[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]





                      SACRED OBLIGATION: RESTORING
                    VETERAN TRUST AND PATIENT SAFETY

=======================================================================

                                HEARING

                               before the

                     COMMITTEE ON VETERANS' AFFAIRS
                     U.S. HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 3, 2011

                               __________

                           Serial No. 112-10

                               __________

       Printed for the use of the Committee on Veterans' Affairs








                                _____

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                     COMMITTEE ON VETERANS' AFFAIRS

                     JEFF MILLER, Florida, Chairman

CLIFF STEARNS, Florida               BOB FILNER, California, Ranking
DOUG LAMBORN, Colorado               CORRINE BROWN, Florida
GUS M. BILIRAKIS, Florida            SILVESTRE REYES, Texas
DAVID P. ROE, Tennessee              MICHAEL H. MICHAUD, Maine
MARLIN A. STUTZMAN, Indiana          LINDA T. SANCHEZ, California
BILL FLORES, Texas                   BRUCE L. BRALEY, Iowa
BILL JOHNSON, Ohio                   JERRY McNERNEY, California
JEFF DENHAM, California              JOE DONNELLY, Indiana
JON RUNYAN, New Jersey               TIMOTHY J. WALZ, Minnesota
DAN BENISHEK, Michigan               JOHN BARROW, Georgia
ANN MARIE BUERKLE, New York          RUSS CARNAHAN, Missouri
TIM HUELSKAMP, Kansas
Vacancy
Vacancy

            Helen W. Tolar, Staff Director and Chief Counsel

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.











                            C O N T E N T S

                               __________

                              May 3, 2011

                                                                   Page
Sacred Obligations: Restoring Veteran Trust and Patient Safety...     1

                           OPENING STATEMENTS

Chairman Jeff Miller.............................................     1
    Prepared statement of Chairman Miller........................    49
Hon. Bob Filner, Ranking Democratic Member.......................     2
    Prepared statement of Congressman Filner.....................    50
Hon. John Barrow, prepared statement of..........................    50
Hon. Michael R. Turner, prepared statement of....................    51
Hon. Jerry F. Costello, prepared statement of....................    52

                               WITNESSES

U.S. Department of Veterans Affairs:
    Hon. Robert A. Petzel, M.D., Under Secretary for Health, 
      Veterans Health Administration.............................     5
        Prepared statement of Dr. Petzel.........................    52
    John D. Daigh, Jr., M.D., Assistant Inspector General for 
      Healthcare Inspections, Office of Inspector General........     7
        Prepared Statement of Dr. Daigh..........................    58
U.S. Government Accountability Office, Randall B. Williamson, 
  Director, Health Care..........................................     8
    Prepared statement of Mr. Williamson.........................    62
U.S. Department of Health and Human Services:
    Michael Bell, M.D., Deputy Director, Division of Healthcare 
      Quality Promotion, Centers for Disease Control and 
      Prevention.................................................    39
        Prepared statement of Dr. Bell...........................    67
    Anthony D. Watson, BS, MS, MBA, Director, Division of 
      Anesthesiology, General Hospital, Infection Control, and 
      Dental Devices, Office of Device Evaluation, Center for 
      Devices and Radiological Health, Food and Drug 
      Administration.............................................    41
        Prepared statement of Mr. Watson.........................    71

                   MATERIAL SUBMITTED FOR THE RECORD

Post-Hearing Questions and Responses for the Record:
    Hon. Bob Filner, Ranking Democratic Member, Committee on 
      Veterans' Affairs, to Hon. Eric K. Shinseki, Secretary, 
      U.S. Department of Veterans Affairs, letter dated May 12, 
      2011, and VA Responses.....................................    76

 
                      SACRED OBLIGATION: RESTORING
                    VETERAN TRUST AND PATIENT SAFETY

                              ----------                              


                          TUESDAY, MAY 3, 2011

                     U.S. House of Representatives,
                            Committee on Veterans' Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:34 a.m., in 
Room 334, Cannon House Office Building, Hon. Jeff Miller 
[Chairman of the Committee] presiding.

    Present: Representatives Miller, Bilirakis, Roe, Stutzman, 
Johnson, Runyan, Benishek, Buerkle, Huelskamp, Filner, Reyes, 
McNerney, Donnelly, Walz, Barrow, and Carnahan.
    Also Present: Representatives Clay, Costello, Luetkemeyer, 
Ros-Lehtinen, Shimkus, Turner, and Wilson.

              OPENING STATEMENT OF CHAIRMAN MILLER

    The Chairman. This meeting will come to order.
    Thank you, everybody, for attending today's hearing 
entitled, ``Sacred Obligation: Restoring Veteran Trust and 
Patient Safety.''
    Before we begin, I would like to ask unanimous consent that 
all the Members whose names are in front of us be allowed to 
sit at the dais. That would be Lacy Clay, Jerry Costello, 
Blaine Luetkemeyer, Ileana Ros-Lehtinen, John Shimkus, Mike 
Turner, and Frederica Wilson. Without objection, they will be 
allowed to participate in today's hearing.
    Mr. Filner. Hold it. I do not want Ileana.
    The Chairman. Okay. Ileana, you have to leave.
    Hearing no objection, thank you all for joining us for this 
important hearing.
    We, as a Nation, put our trust in the men and women who 
serve in our Armed Forces to protect us and our freedom. And in 
return, our servicemembers put their trust in us to provide 
them with the highest quality healthcare.
    However, incident after incident of serious patient safety 
violations in U.S. Department of Veterans Affairs (VA) medical 
facilities across the Nation in locations such as Dayton, St. 
Louis, and Miami resulting in thousands of veterans across the 
country receiving notification of their potential risk for 
infectious diseases like the human immunodeficiency virus (HIV) 
and hepatitis shatters that very trust that veterans should 
have in each of us.
    After each of these incidents, the VA assured Congress and 
the country that it was aggressively addressing patient safety 
issues and never again would a veteran's trust be compromised 
by lapses in quality care at a VA medical facility and, yet, 
each patient safety incident has seemingly led the way for the 
next lessons learned and the unacceptable and inexcusable 
revelation that the patient safety culture in VA is fractured 
and accountability and leadership at the helm are lacking.
    The time for talk is over. VA has to confront these issues 
head on, deepen the obligation to care for the veterans 
affected by these incidents, and make the necessary changes 
within the VA healthcare system to prevent any future incidents 
that would put veteran patients at risk.
    To that end, at this hearing today, we will address in 
depth the efficacy of VA's patient safety policies and VA 
leadership's ability to provide adequate oversight of its 
medical facilities.
    Further, we are going to explore the development of 
proactive strategies for addressing the issues that underlie 
the lapses we have seen in patient safety including the need 
for improvements in reprocessing of reusable medical equipment, 
systematic ways for VA to limit the activities of suspect 
practitioners, and better and more consistent risk management 
and notification processes for veteran patients when incidents 
do occur.
    It is unconscionable that any one of our veterans should 
ever be exposed to infectious diseases because of the care they 
receive at a VA medical facility.
    I want to assure all of you that this Committee will be 
tireless in its oversight to ensure that VA lives up to its 
creed to provide only the very best and the very safest care 
anywhere.
    I thank you all for joining us for this ongoing and most 
important discussion.
    Before I yield to the Ranking Member, I would like to 
remind the witnesses that testimony is due no later than 48 
hours in advance of a Committee or a Subcommittee hearing. I am 
told that the Disability Assistance and Memorial Affairs (DAMA) 
Subcommittee did not receive VA testimony until late yesterday 
in preparation for today's 8:00 a.m. hearing. To me, that is 
inexcusable.
    And in addition, I and other Committee Members submitted a 
series of questions 7 weeks ago in relation to VA's 2012 budget 
request, yet no responses have been received.
    I would ask those here representing VA to please convey my 
disappointment about this performance and my expectation that 
things will improve in the very near future.
    And with that, I yield to the Ranking Member, Mr. Filner, 
for an opening statement.
    [The prepared statement of Chairman Miller appears on p. 
49.]

              OPENING STATEMENT OF HON. BOB FILNER

    Mr. Filner. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    Obviously we want to gauge VA's response to several recent 
incidents that profoundly affect veterans, as you pointed out, 
due to the failure of some to follow policies, procedures, and 
protocols that have been put in place to prevent such 
occurrences.
    We are going to look at what measures have actually been 
implemented to ensure that these types of lapses never happen 
again.
    I have to say, and I think you would certainly agree, Mr. 
Chairman, that we have been here before. You have acknowledged 
some of the events, but let me just point out the most recent 
things.
    In December 2008, we were notified of improper reprocessing 
of endoscopes, which put thousands of veterans in Murfreesboro 
and Mountain Home, Tennessee and Miami, Florida, at possible 
risk of hepatitis and HIV.
    In February of 2009, another thousand veterans in Augusta, 
Georgia, received notifications that they were at risk for 
hepatitis and HIV because of improper processing of ear, nose, 
and throat endoscopes.
    In July 2010, this Committee held a field hearing in St. 
Louis, Missouri, which you attended, Mr. Chairman, along with 
many of our colleagues here today after we had learned of 
lapses in protocol with the cleaning of dental equipment, which 
put at risk 1,800 veterans.
    The most recent notification, the egregious incidents in 
Dayton, Ohio, affected over 500 veterans and involved a whole 
host of problems.
    The findings beg the questions of proper accountability, 
effective oversight, and enforcement of clear policies and 
procedures.
    Policies and procedures that are sometimes not followed or, 
worse, get completely ignored are the issue. I would like to 
know where is the strong leadership and effective communication 
that is critical when you are entrusted with the care and well-
being of our Nation's veterans.
    Let me point to another big concern as a result of these 
incidents and that is the absolute need for effective 
communication within management ranks and below and also 
between management and the Congress.
    I am sure that the Secretary of Veterans Affairs agrees 
with me on this.
    Clearly, VA has had issues with ensuring the sterility of 
reusable medical equipment in the past and now other patient 
safety issues have come to light as evidenced in the continuing 
problem of veterans being vulnerable to infectious diseases due 
to the problematic yet prevalent issue of lack of following 
sound agency guidelines and policies concerning patient safety.
    In addition to what has been looked at over the past 3 
years, I am strongly dedicated to the need for ensuring that we 
do everything possible so we do not trouble our veterans again.
    As we are all well aware, VA has a higher commitment and a 
moral compact to provide the utmost level of care possible. It 
is this Committee's responsibility to ensure that VA has the 
proper resources to fulfill that mission.
    Of course, we want to acknowledge and recognize the VA's 
excellent healthcare services overall and the dedication of the 
vast majority of its staff. The work that you have done so far 
to try to mitigate the issues that we will be discussing today 
is to be commended.
    I would like to pretend that I am looking forward to 
today's hearing, but I am not. These are not easy questions. 
And, frankly, Mr. Chairman, the issues go beyond just the 
incidents themselves.
    They go to the communication within the VA. It took a long 
time for the right people to know what was going on in each of 
these incidents. It goes to the communication with our VA 
patients. Sending a letter that basically says you may have HIV 
is not the way to deal with these issues.
    There is no case management. There is no way for the 
veteran to really talk about what is happening, what the 
probability of infection is, how to get immediate help, blood 
tests and everything else. A phone call going out or a letter 
going out to 1,500 people or 1,800 people without further 
explanation, without a 24-hour hotline to call?
    As far as I know, on some of these incidents, neither the 
Secretary, nor this Committee, was ever notified for days or 
weeks of the incident. We people at the VA trying to figure out 
how to cover it up or try to stifle the whole thing rather than 
allowing the most information possible? It seems to me that the 
culture of secrecy, the culture of covering up is too prevalent 
here.
    Mistakes are made in every institution and they will be 
made in the VA. But we have to acknowledge and deal with them, 
get the information out as quickly as possible and honestly 
figure out what happened.
    As far as I know, and maybe the panel can correct me, with 
all these incidents, we have never been told, Mr. Chairman, of 
any personnel changes as a result. The only way to send a 
message to an organization that we take these things seriously 
is by firing or whatever.
    I know you have all kinds of guidelines for this to protect 
employee rights and information, but there has to be a way, 
even with the issues of the employee rights, to understand 
there is accountability here.
    I do not know of anybody who has ever been fired. I do not 
know of anybody who has ever been let go. I do not know of 
anybody who has been specifically reprimanded, punished, or 
dealt with when they put the safety of these veterans in 
jeopardy.
    I think there probably have been, but we have never been 
told that. You tell us that personnel changes have been made. 
That is not enough. That is not enough. That is not enough to 
assure us and then that is not enough to assure the public. 
That is not enough to make sure that the good employees at the 
VA know that if someone makes a mistake, they are going to be 
dealt with.
    I think we have to find a new way to handle this, Mr. 
Chairman. Not just the procedures and sterilizations, but how 
are you going to deal with accountability in a public 
institution when employees do have rights, but the public 
accountability is paramount?
    We have to understand that and deal with it in a new way.
    I thank the Chairman.
    [The prepared statement of Congressman Filner appears on p. 
50.]
    The Chairman. I thank the Ranking Member for his opening 
statement.
    And as usual with this Committee, we ask that all Members 
hold their statements so that we can get to the witnesses, but 
each Member will be allowed to enter their statement into the 
record without objection for printing purposes.
    And I would like to welcome the first panel to the table 
this morning, Dr. Robert Petzel, who is VA's Under Secretary 
for Health; Dr. John Daigh, Assistant Inspector General for 
Healthcare Inspections at the VA Office of Inspector General 
(OIG); and Mr. Randall Williamson, Director of the Healthcare 
team at the U.S. Government Accountability Office (GAO).
    Gentlemen, thank you very much for joining us here this 
morning.
    And, Dr. Petzel, you may proceed.

STATEMENTS OF HON. ROBERT A. PETZEL, M.D., UNDER SECRETARY FOR 
  HEALTH, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
VETERANS AFFAIRS; JOHN D. DAIGH, JR., M.D., ASSISTANT INSPECTOR 
    GENERAL FOR HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR 
 GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND RANDALL B. 
      WILLIAMSON, DIRECTOR, HEALTH CARE, U.S. GOVERNMENT 
                     ACCOUNTABILITY OFFICE

            STATEMENT OF HON. ROBERT A. PETZEL, M.D.

    Dr. Petzel. Chairman Miller, Ranking Member Filner, and 
other Members of the Committee, thank you for the opportunity 
to discuss the Department of Veterans Affairs' patient safety 
policies and strategies to build trust and ensure the safe and 
compassionate care of this Nation's veterans.
    I am accompanied today in the first row by Dr. Robert 
Jesse, the Principal Deputy Under Secretary for Health; Mr. 
William Schoenhard, Deputy Under Secretary for Health, 
Operations, and Management; Dr. George Arana, Acting Assistant 
Deputy Under Secretary for Health for Clinical Operations; and 
Dr. Andrea Buck, Acting Chief Medical Officer.
    I have submitted the written testimony and ask that it be 
entered into the record.
    First and foremost, I want to apologize on behalf of the 
Department of Veterans Affairs to those veterans who have been 
affected by these lapses in patient safety practices at any of 
our facilities.
    The primary commitment of every VA employee is the well-
being of our veteran patients. When a lapse in patient safety 
practices occurs, we believe that we must be open and 
transparent with regard to our mistakes and any necessary 
actions that need to be taken.
    We carefully consider the effects of any disclosure, but 
our practice is to provide more information to our veterans in 
an abundance of caution even if the risk is very, very low.
    We believe we provide excellent healthcare overall. Despite 
caring for patients that are on average sicker, older, less 
affluent than the general population, VA's performance exceeds 
the best U.S. healthcare systems.
    We are very open with our information. We report more 
quality data about our programs online than any other 
healthcare system in this country.
    Our written statement provides an overview of our quality 
and safety programs, our practices for standardization, of 
reprocessing, and our credentialing and privileging practices 
and finally our risk management and notification for patients' 
procedures.
    Right now I would like to make three points. First, we are 
focused on continuous improvement to all of our programs. We 
publish an annual report on each facility's quality and safety 
performance online and we are providing data to the U.S. 
Department of Health and Human Services' (HHS) Web site so that 
veterans can compare the care that is delivered in their 
facilities with the care that is delivered in the private 
practice.
    We conduct detailed investigations of not only adverse 
events but of close calls because even if a veteran was not 
harmed in a particular situation, we never want to put that 
patient at risk for that particular problem again.
    We subject our facilities to dozens, dozens of reviews 
annually. Our facilities are subjected to inspections by the 
Joint Commission, the Commission on Accreditation of 
Rehabilitation Facilities, the Inspector General, the Medical 
Inspector, the GAO, and a number of other external and internal 
quality and safety reviews.
    We not only appreciate this oversight, we welcome it. It is 
through these internal and external assessments that we can 
detect problems, identify best practices, and change the way we 
do our business. No matter what the outcomes, these reviews do 
improve the care that we deliver to our veteran patients.
    Secondly, we have made significant progress in 
standardizing, sterilizing, and processing reusable medical 
equipment across the country. Several of the incidents that are 
being discussed today were the result of improper reprocessing 
of reusable medical equipment. This is one area we are looking 
at for even further enhancements.
    We standardized the purchase of reusable medical equipment 
and we are using leases to ensure that the latest and best 
equipment is available so that we go from 40 different brands 
of colonoscope at a medical center to less than 10 brands of 
colonoscope at that medical center to simplify the process of 
re-sterilizing that equipment.
    We have created an Office of Clinical Consultation and 
Compliance that is implementing better tracking and 
documentation control measures over our reusable medical 
equipment.
    And we are subjecting our programs to the requirements of a 
program called ISO-9001. This is an industrialized, 
standardized process for quality control. And we are 
collaborating with the leaders in this field to improve our 
training, accountability, and practices in our Supply, 
Processing and Distributions (SPDs).
    We are looking to work with the private sector to automate 
our practices to reduce the potential for human error, and four 
levels of review of our SPD programs are conducted. The 
facility does reviews. The network or Veterans Integrated 
Services Networks (VISN) does reviews. There are national 
reviews and we have external entities that review our SPD 
processes on an annual basis.
    Finally, we have a careful assessment process to determine 
when we should disclose an event to veterans. We convene a 
fact-finding board to discuss the event and a clinical review 
board to determine if disclosure should occur. This rigorous 
process has been recognized by The New England Journal of 
Medicine as a best practice and a model for the rest of the 
country.
    These boards are comprised of subject matter experts from a 
range of disciplines to determine who should be notified and 
how we best should do that.
    In conclusion, our mission is to serve the Nation's 
veterans by providing them the best healthcare anywhere. We 
take this responsibility very seriously. And we appreciate the 
opportunity to discuss these programs that we have in place to 
deliver on this promise.
    Thank you for inviting us to testify here, and my 
colleagues and I look forward to your questions.
    [The prepared statement of Dr. Petzel appears on p. 52.]
    The Chairman. Thank you, Dr. Petzel.
    Dr. Daigh.

             STATEMENT OF JOHN D. DAIGH, JR., M.D.

    Dr. Daigh. Good morning, Mr. Chairman, Ranking Member, 
Members of the Committee. It is a privilege to discuss the 
published work of the Office of Inspector General as it relates 
to the patient safety issues under discussion today.
    I believe that based on the body of work that we have done 
over the last several years, the VA does, in fact, provide 
high-quality medical care to veterans. Nevertheless we are here 
today to discuss failures by VA to provide properly 
reprocessed, reusable medical equipment at the point of care, 
delivery thus resulting in the notification to thousands of 
veterans that they are at risk of becoming infected with blood-
borne pathogens.
    My conclusion is that these instances result from two 
problems. One is the inability of selected facilities to follow 
established guidelines and directives with a zero defects 
culture, that is to do their job correctly every day and every 
time.
    The second problem that I see from these issues is 
instances of leadership failure where compromises were made to 
acceptable infection control standards that placed veterans at 
risk.
    I recommend the VA consider changes to their current 
policies and procedures and offer a few suggestions.
    One, the hospital leaders must have unfettered input from 
their employees, particularly those employees who I would call 
technicians. They run the lab. They operate the ultrasound 
machines. They provide and support a great deal of the care 
that is provided throughout the hospital.
    The nurses have a direct line of flow of data to the 
hospital leadership. The providers have a direct line of flow 
of unfettered data. I think it is imperative that the hospital 
director reach out and speak directly with the technicians to 
ensure that the data is congruent, that they are hearing about 
what is going on in their hospital.
    The second, I think VA should consider position rotations 
or forced vacations as a management tool in selected 
circumstances. Where senior hospital leadership is viewed as 
unresponsive to employee concerns, the quality of medical care 
may be placed at risk.
    The third, I believe VA has, in fact, an excellent adverse 
event disclosure policy that is, in fact, the national 
standard. However, I think in light of recent events, I think 
it is time to have a broader discussion of the risk management 
policies and the communication policies that entail this 
adverse event disclosure issue.
    And, fourth, I think senior hospital officials must very 
carefully examine those instances in which a provider has 
privileges at the hospital that are less than expected for that 
provider's position or recent history. A limitation of 
procedures alone may not provide the margin of safety 
anticipated by the credentialing and privileging Committees.
    I thank you for this opportunity to testify today and will 
do my best to answer your questions.
    [The prepared statement of Dr. Daigh appears on p. 58.]
    The Chairman. Thank you, Dr. Daigh.
    Mr. Williamson.

               STATEMENT OF RANDALL B. WILLIAMSON

    Mr. Williamson. Good morning, Members of the Committee.
    The Chairman. You might check your microphone really 
quickly.
    Mr. Williamson. I am sorry. I am pleased to be here today 
to discuss our report issued this morning that addresses VA 
policies and oversight governing the cleaning and disinfecting 
of reusable medical equipment, which I will refer to as RME.
    Lapses by some medical centers in cleaning such equipment, 
which includes dental instruments, endoscopes, and surgical 
instruments have recently come to light. Such lapses have put 
thousands of veterans receiving care at these medical centers 
at risk to exposure of HIV, hepatitis, and other infectious 
diseases.
    In my testimony today, I will describe our findings in two 
areas. First, I will address deficiencies in VA policy 
requirements for training its medical center staff to properly 
clean and disinfect RME. And, second, I will discuss needed 
improvements in VA's oversight of medical center staff to 
ensure that they comply with these policy requirements.
    Regarding the first area, we visited a cross-section of six 
VA medical centers across the Nation and found some disturbing 
deficiencies with respect to VA requirements for devicespecific 
training for cleaning and disinfecting RME. These deficiencies 
indicate systemic problems that need to be corrected at the 
national level.
    Two issues came to light here. For one, almost all medical 
center officials we talked with said that VA guidance was 
unclear as to which types of RME required devicespecific 
training to ensure proper cleaning techniques. This resulted in 
devicespecific training not being developed at all six medical 
centers we visited for some critical RME such as surgical 
instruments.
    At one medical center, for example, officials told us they 
had developed devicespecific training for non-critical RME such 
as wheelchairs, but they have not completed training for more 
critical RME.
    Another training issue involved conflicting guidance that 
was provided to medical care staff about developing training on 
how to clean RME.
    Officials in three medical centers, for example, told us 
that certain headquarters' or VISN officials had told them to 
develop devicespecific training for RME that closely matched 
manufacturer guidelines.
    Later other headquarters' and VISN officials told them to 
write reprocessing instructions in a way that could be readily 
understandable rather than strictly following the manufacturer 
guidelines.
    This led to multiple rewrites of training instructions by 
medical center staff, which are both time consuming and a waste 
of resources and could lead to preparation of insufficient 
training instructions for cleaning RME at some medical centers.
    Headquarters' officials told us they are aware of these 
deficiencies and have begun efforts to remedy them. For 
example, VA officials said they have recently gained access to 
a commercial database of standardized devicespecific training 
developed by manufacturers for over a thousand pieces of RME 
and have made this database available to medical centers.
    For RME where manufacturers have not developed 
devicespecific training, VA officials said they plan to develop 
this training and provide standardized instructions to its 
medical centers. But at the time of our review, VA had not yet 
done this and had no firm plans or time table for completing 
this task.
    With respect to RME oversight, VA has recently initiated 
efforts to improve its oversight of medical centers with 
respect to complying with RME reprocessing requirements. These 
efforts include increasing the frequency of unannounced site 
inspections to medical centers, requiring VISNs to use 
standardized assessment tools, and requiring the results of RME 
inspections at medical centers to be reported to headquarters.
    Despite these changes, improvements in VA oversight are 
still needed. Most notably, while VA now requires that all RME 
inspection results from its medical centers and VISNs be 
submitted to headquarters, VA does not systematically analyze 
this information across its medical centers. Such analysis are 
important to assess the extent and risk of noncompliance with 
RME reprocessing requirements across its medical centers and to 
determine whether identified noncompliance cases have been 
addressed.
    VA headquarters' officials said they planned to address 
oversight weaknesses we identified including analyzing 
information to identify noncompliance with RME requirements 
across its medical centers. However, completing these changes 
is contingent on implementation of the VA organizational 
realignment in this area which was still ongoing earlier this 
month.
    In summary, while VA has taken some steps to strengthen 
both its methods for reprocessing RME and its oversight over 
this process, much remains to be done. Until VA's improvement 
efforts in this area are completed, veterans may continue to be 
at risk to RME related infectious diseases.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Williamson appears on p. 
62.]
    The Chairman. Thank you for your testimony.
    And we will start a round of questioning. As our usual 
course, Committee Members will go first and then we will have a 
round for the non-Committee Members as well.
    But on my time, and I will adhere to the 5-minute clock as 
well, Dr. Petzel, would you like to respond to Mr. Williamson 
and his presentation regarding their report?
    Dr. Petzel. Thank you, Mr. Chairman. I would.
    We appreciate both the GAO and the OIG inspecting our 
reusable medical equipment processes as well as the other 
things they do because, as I said in my oral testimony earlier, 
we do learn. And we have concurred in the recommendations that 
the GAO specifically made.
    I want to point out a couple of things. Number one is that 
we do now have a standardized database that covers the 
majority, the vast majority, in fact, of the processes, the 
standard operating procedures for processing reusable medical 
equipment. And that means we do have across the country 
standardized operating procedures for cleaning. In those areas 
where the commercial database does not cover, we have developed 
those ourselves.
    And contrary to what Mr. Williamson said, we do not 
tolerate people writing their own procedures. We have a 
standard for cleaning whatever that piece of equipment is 
across the country. It may not have been completely in place at 
the time they did their inspection, but it is now and it is our 
practice around the country.
    The Chairman [continuing]. If I could----
    Dr. Petzel. Two----
    The Chairman. If I could, on number one, you said in place 
for most of, but the implication is not all?
    Dr. Petzel. Well, what I said was that the commercial 
database that we bought does not cover absolutely everything. 
And we have developed or we have in place processes for those 
things not covered, which are relatively few, not covered by 
this database that we----
    The Chairman. Give me an example of what would not be 
covered.
    Dr. Petzel. There might be some small surgical instruments.
    The Chairman. Does that mean you wrote them or----
    Dr. Petzel. That means the manufacturer has them, they are 
not in the database, and we use the manufacturer's information.
    The Chairman. So you do have everything covered, but some 
is not in that database that you purchased?
    Dr. Petzel. That is correct.
    The Chairman. Okay. And number two?
    Dr. Petzel. And number two is that the training that was 
described in the GAO report is, in fact, in place and has been 
done in the vast majority of our places. We have begun a 
process of certification for all of our technicians. We have 
developed an institute or an academy of SPD where we bring 
people specifically down to go through the training process.
    We require that every SPD document the fact that their 
people, their technicians have been trained on the instruments 
that they are responsible for reprocessing.
    And I believe that the last look that the OIG made at how 
well we have done with that training indicated that we were 
close to but not yet perfect in terms of the number of people 
that were trained. In other words, there were some instances 
where they found no evidence of the training, not that the 
training had not been done, but no evidence.
    So that is number two is that we have indeed set up a 
process for ensuring that our people are properly trained.
    And then the last item that I wanted to discuss in the GAO 
report is the Central Office oversight, again a point that we 
agreed with, that we need to have in place the mechanisms that 
allow us to be assured and are able to assure our patients and 
you all that we are periodically looking at the SPD and how it 
is functioning and assuring ourselves, you all, and the public 
that indeed those things that we say need to be done are being 
done, the training, the following standard operating 
procedures, et cetera.
    As I mentioned in my oral testimony, there are four levels 
of oversight that occur in the SPD. There is a local 
requirement for oversight. We changed the reporting structure 
in SPD to a clinical person, the nurse executive in the 
executive quadrant.
    We require that the networks periodically, three times a 
year, inspect the SPD using a standardized assessment tool 
which I think most people would agree is probably a benchmark 
standard within the industry. Then we from Central Office do 
our regular periodic inspections of the SPD for both infection 
control processes and reprocessing.
    And then finally, as mentioned, there are a number of 
outside organizations that periodically look. The OIG does 
their combined assessment programs that include looking at the 
SPD and that is done every 3 years. The Joint Commission looks 
at SPD. The medical inspector periodically looks at SPD. We 
have an internal Systematic Ongoing Assessment and Review 
Strategy (SOARS) process that looks at SPD.
    So there are at least nine levels of oversight of SPD right 
now.
    The Chairman. I think in your opening statement you talked 
about four levels of oversight.
    I think the GAO talked about inability to follow guidelines 
and need for unfettered input from employees. They found 
disturbing deficiency and systematic problems. You said you 
have begun a process of certification.
    If you do all of those things and your managers do not 
follow the rules, what do you do?
    Dr. Petzel. We would discipline them.
    The Chairman. Have you?
    Dr. Petzel. We have.
    The Chairman. Have you fired anybody?
    Dr. Petzel. We have proposed removal in a number of 
instances and almost invariably the individual has resigned or 
retired as a result of the proposed removal.
    The Chairman. Can you give us a number of individuals that 
you proposed removal of?
    Dr. Petzel. There are, I believe, three physician or dental 
level people that that has occurred with, several chiefs of SPD 
where that has happened. We have also reprimanded individuals, 
suspensions, and letters of counseling.
    The Chairman. One of the dentists was in his eighties; is 
that correct?
    Dr. Petzel. Close, yes.
    The Chairman. Mr. Filner.
    Mr. Filner. Dr. Petzel, you are here as a representative of 
the VA. We have gone through this before, sir. It seems to me 
your job here should have been, and we have Members of Congress 
from all the districts that have been affected, was to begin to 
restore some trust and confidence in your institution.
    I hate to take a poll. If I did, if I asked how many people 
now have confidence that everything is fine in your VA 
hospital, I doubt if anybody would raise their hand. You said 
everything was fine. It is not true, simply not true.
    You talk about transparent procedures and New England 
Journals, best practices, and, yet, every time something 
happens, we have a disaster.
    We do not have a way of communicating. We do not have a way 
of dealing with the personal concerns. We do not have any 
knowledge that anybody has been reprimanded.
    Now you tell us that you have reprimanded three employees. 
We have been going over this for years and now hear these 
results. Still, you have never told this Committee those 
figures before, as far as I know.
    But, Dr. Petzel, we have gone through this before. We have 
raised concerns in our opening statement. You read your opening 
statement as if we never said anything. So you never addressed 
issues of accountability. You never addressed issues of 
communication, whether within your agency, the veterans or with 
this Committee.
    I have gone through the timelines with almost every one of 
these Members here and their hospitals. You say panels get 
together to decide should we disclose, what should we disclose, 
who should we--it looks to many of us like they get together to 
decide what do we keep secret from our--you keep shaking your 
head no.
    Why did it take 8 weeks at St. Louis where Mr. Carnahan 
will raise the issues for that panel to decide to tell people 
that almost 2,000 people were infected, possibly infected with 
HIV? It took 2 months before you guys decided that.
    The Secretary was not notified, as far as I know, in his 
words to me during that whole period of time. It sounds like 
you are sitting there deciding ``what is the minimal amount of 
information that we can give out so people do not get upset 
with us'' rather than the maximum.
    That first day, I would have had the Secretary have a press 
conference and explain the possibility of X hundred or X 
thousand of people being exposed. We are going to get to you 
right away. We want to make sure you know this is happening and 
put pressure on yourselves to become public because, otherwise, 
there is no pressure for you to do anything.
    We did not know anything. The Secretary did not know 
anything. I do not know if you knew anything because these guys 
are basically meeting to determine how to keep this secret for 
as long as possible and maybe we do not have to disclose at all 
because your question was, should we disclose, not how to do 
it.
    As I said, your whole disclosure process is as if everybody 
knows all your acronyms and your initials for everything and 
all these SPDs and RMEs as if the patients know what is going 
on.
    They get a letter. I have seen these letters. It says 
basically, it is not this bad, but you may have HIV. They get a 
letter. It may have even gone to a wrong address.
    For 1,500 people, as I said to you earlier at a hearing, 
you should have had 1,500 of your 250,000 employees, assigned 
to somebody to call them, go visit them, find out when they can 
come back, when they can get their blood test. Treat them as if 
they may have HIV, and they are scared to death that they are 
going to die. Instead, you send them a letter.
    There is no one necessarily there to answer a phone call 
when they call back because you do not have people working this 
like case managers. One person to every five people is not 
enough, I think you should do one on one.
    What you described as this open, transparent process does 
not come through. And every one of these people has 
constituents which I bet can confirm what I just said. Even if 
it is only the perception and not reality, that is just as bad. 
You were not very personal in your notification. You were not 
very clear about what it is that they might have. You did not 
followup in a way that was very quick. And then, we do not know 
anything about accountability. We know nothing from basically 
what you said today.
    You have to develop a new system. We just killed Osama Bin 
Laden and they notified eight Members of Congress and the 
Committees were notified and, they kept that confidential. 
Maybe you should notify the Chair and Ranking Member of the 
Veterans Committees about what you are doing in terms of your 
personnel.
    But there is no sense that you have done anything. Nobody 
in Dayton, nobody in St. Louis, nobody in Miami, nobody in 
Tennessee knows anything about that accountability. And I doubt 
anybody in the system knows about it, so they do not think 
there is any accountability.
    So I wish you would address these issues. We have gone over 
them for several years. You and I have gone over these exact 
issues several times at hearings and then you do the exact same 
thing. You give me a prepared statement that everything is 
fine. You move the discussion into these arcane things about 
SPDs and RMEs and you neglect the basic issues of communication 
and accountability that are at the heart of the confidence that 
our people have in your system.
    You may comment in any way you want.
    Dr. Petzel. Thank you, Mr. Filner.
    What I want to do is first talk about our notification 
process. The process by which we determine who ought to be 
notified or who might be at risk, as I said before, is an 
industry standard. I will stand by that process. Under any 
circumstance, it takes some time, but it is transparent and it 
is weighted heavily in the favor of----
    Mr. Filner. Nobody knew about St. Louis for 8 weeks, 8 
weeks.
    Dr. Petzel. Sir----
    Mr. Filner. If that is the industry standard, you should 
not--we should not be following the industry standard.
    Dr. Petzel. Sir, I am not talking about the communication. 
I am talking about the process that we go through. It is very 
thorough and it is weighted on the side of being abundantly 
cautious to be sure that we take into account every possible 
risk.
    The process by which we disclose to patients involves 
letters, phone calls, and case managers, particularly in the 
instance of St. Louis. Every single individual that was 
affected was called. They were offered a case manager. There 
was a case manager involved. In fact, in some instances, the 
leadership of the medical center.
    I will admit that we have learned iteratively since the 
first episode----
    Mr. Filner. But, sir, that conflicts exactly with what you 
said to me at St. Louis. The Chairman was there. Mr. Carnahan 
was there and Mr. Clay was there. Mr. Shimkus was there. You 
never mentioned the word case manager. You never mentioned that 
they were called.
    Is that right?
    Dr. Petzel. No.
    Mr. Filner. I mean, we went through this discussion with 
you. This is the first word I ever heard of a case manager 
because I said to you, why don't you have case managers. You 
said, yes, we will look at that.
    We are both going to review your testimony in St. Louis 
because it is contrary to what you just said now.
    Dr. Petzel. Again, we have learned iteratively about the 
process of notifying people and early in this with the first 
episodes that we had in Miami and Augusta, I do not think we 
did a good job to be very candid with you.
    But with the next several episodes, I think we have done a 
better job of sending letters, calling people, and giving a 
hotline number to call and making people available to them to 
answer their questions about what happened.
    And, again, after reviewing what is done across the Nation, 
I would stand by the process that we have right now as being an 
excellent way of notifying people when there has been potential 
exposure.
    Mr. Filner. I hope all of our non-Committee Members who are 
here will speak to those issues from the way you saw them or 
your constituents told you. I hope so.
    Thank you.
    The Chairman. Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    And not too many questions, but having served as chief of 
staff of a hospital and a hospital board chairman, you are 
responsible and you feel that responsibility for the care that 
is given by your institution.
    And I have noticed a couple of things here that bother me a 
little bit for the last couple of years is that when you talk 
about the instruments, SPDs where the instruments are cleaned, 
it really gets down to one or two or three people in any 
hospital that are doing this. It is not a whole big system. It 
is people doing it.
    And those people probably think they are doing the job 
right, but if they have not been trained to do it properly, 
they are going to continue to do it wrong.
    I can assure you that in the private sector, had this 
occurred like this just did and a medical/legal case had 
resulted out of it, you just get your pencil out and start 
writing commas and zeros. I can tell you can get the checkbook 
out because this private system would not tolerate this.
    I can tell you right now when you have this no matter if it 
is the SPD that does it, I know who is captain of the ship and 
I know who is going to be responsible for that error that has 
occurred. And there have been numerous errors here.
    One of the things that we have to sell in medicine is 
trust. Our patients need to trust us. They need to trust the VA 
that that is where the quality of care and transparency. Mr. 
Filner is absolutely 100 percent correct. I can assure you that 
when I had a problem go wrong in my shop when I practiced 
medicine, not the clerk that answered the phone made the call 
to the patient, I made the call to the patient. I called them 
up. I explained to them. I had them come in and tell them what 
was going on.
    And I can tell you in a large institution with multiple 
people, I would have had the highest level people contacting 
someone when they think they have HIV or a potential life-
threatening condition.
    Now, because these instruments were cleaned in a certain 
way does not mean that it gave the patient that. We do not know 
what the incident was to start with. I mean, we do not know, in 
these patients, we do not know, but they do not know either.
    So I think Mr. Filner is absolutely dead on right. And it 
is not the crime. It is the cover-up or even perceived cover-
up. I mean, nobody is trying to hide. I do not think you are 
trying to hide anything. I know that. In my gut, I know that.
    But you have a huge system and you have to put systems in 
place where people are trained and to where their training is 
evaluated so that those things do not occur. And I do not have 
the feeling yet that that has been done. Maybe it has been. 
Maybe you can make me feel better. But from what I hear from 
Mr. Williamson, he did not see it that way.
    Comment.
    Dr. Petzel. Dr. Roe, I believe the training is in place. I 
do believe the policies are in place to do this.
    The Chairman. Doctor, could you hit your microphone? Thank 
you, sir.
    Dr. Petzel. I do believe it is up to our oversight 
processes to assure us, assure you, and assure the veteran 
population that, in fact, those things are being done.
    We have learned a lot from these episodes going back to 
2008. And I think we are a better system because of it and I 
think we do have the best, if you will, in terms of 
reprocessing an SPD that is available in this country right 
now.
    Mr. Roe. One of the things that we had in our medical/legal 
training in Tennessee was we had the airline people come to us 
and go over their procedures, which are absolutely textbook. 
Now, when you take a plane off and you will almost find out 
every time it is a pilot error.
    And what you will find out here without oversight, it will 
be an individual person making an error as in the dentist 
example you gave. But that was not dealt with. That is the 
other problem is that when you see that problem, it has to be 
dealt with.
    And I have done that. It is not fun to go in to talk to 
somebody who is a 30-year member of your shop and say you are 
not performing at the level we accept. That is not easy. I have 
done that. That is very hard to do.
    And I do not get the feeling that that was handled very 
well when this problem apparently was identified for years and 
never dealt with. So again, you have to have those procedures 
in place and then you have to follow those procedures and they 
have to be lock step. If you do not, you will have these 
errors.
    And I think the other thing you are doing is it is much 
simpler when you have the same equipment all the time. And you 
have multiple kinds of equipment and doctors are terrible about 
that. We have our little toy we like to play with. But we can 
play with any toy if we learn how to do it. The fewer toys you 
have, the easier it is to not make those errors.
    Dr. Petzel. I absolutely agree with that last comment. We 
are frantically standardizing our reusable medical equipment. 
We just signed two lease contracts for colonoscopes and 
endoscopes. There are only two manufacturers. The fact that 
they are leases means that we will be able to turn over the 
latest model.
    What has happened in the past is that they will buy some 
new endoscopes, but they will keep the old endoscopes as well. 
So you have maybe 7 or 8 years worth of models all of which 
have different instructions about how to clean, et cetera. This 
is going to allow us to have only the most up-to-date models 
and many, many fewer instruments that we have to learn the 
procedures for cleaning. I think that is an excellent point.
    Mr. Roe. Thank you.
    I yield back, Mr. Chairman.
    The Chairman. Mr. Walz.
    Mr. Walz. Thank you, Mr. Chairman.
    And thanks to all of our witnesses for being here.
    And I, like Dr. Roe, was at that hearing a few years ago on 
the endoscopes. And I do appreciate some folks brought several 
into my office and taught me how to do it because my goal was 
to see exactly what the procedure here was.
    And I want to be very clear. Everybody in this room, the 
care of our veterans is the number one concern. And I 
absolutely have no doubt of that. It is a zero sum game. One 
injured veteran is one too many.
    But I want to bring up, Mr. Williamson, to you, and I was 
looking at a recent New England Journal of Medicine report, let 
us be very clear here that this is not a problem associated 
with only the VA.
    How do the private hospitals report this? When I hear 
numbers of 98,000 deaths, 1.5 million injuries per year in the 
private sector and I was. Dr. Roe, I am going to have to get 
with you on that. I almost thought I heard you saying that the 
threat of the legal action kept people doing better things, but 
I will clarify that with you.
    But the idea on this is how much, how prevalent, can you 
make any comparison to--is this systemic with the leadership in 
the VA or how things are done or is this is a broader problem, 
which I would argue representing places like the Mayo Clinic 
and VA facilities that it is systemic across the board in 
medical delivery.
    Mr. Williamson. Well, Mr. Walz, you may be right about the 
breadth of it, but we basically concentrated on VA. We did not 
examine any private-sector data in this regard.
    Mr. Walz. So we do not have the ability then to--we were 
using best practices there, but the argument I would make is 
are we absolutely certain, and do not get me wrong, one is too 
many, but are we absolutely certain the practices being applied 
in the VA are worse than the private sector even though our 
goal is to have the best care?
    Dr. Petzel, can you----
    Dr. Petzel. Congressman Walz, thank you. I can make just a 
couple of comments.
    The New England Journal of Medicine article that I was 
describing before that cites us as being the best, the best 
example of how to assess risk and how to contact patients also 
cites 18 other examples of potential exposure across the 
country ranging from 40,000 people in one instance to just a 
couple in another. It is a prevalent problem across the 
country.
    I believe, and we have had some confirmation of this from 
other people, that we are doing an excellent job of trying to 
achieve the Six Sigma performance in our SPD.
    The ISO-9001 that I spoke about before is an 
industrialization of the whole process. Very few other people 
are doing that in their SPDs. The inspections that we go 
through are not done in many other parts of the country.
    So I think that, I mean, I do not want to compare us to the 
private sector completely, but I think we are doing a good job, 
not a perfect job. As has been pointed out by a number of 
people, we have to do better and we will continuously improve 
this. But I think we are on the right path.
    Mr. Walz. So the Six Sigma process is translating. Are we 
focusing on the one/one-thousandths in here because I said even 
if that is what it is, we are going to focus on that, the care 
for our veterans? Is that what is happening?
    Dr. Petzel. That is the kind of performance that we are 
trying to emulate, correct.
    Mr. Walz. That is right.
    Mr. Williamson. I would add, too, though, that we looked at 
VA policies and what VA requires and the standard of excellence 
that they require of their people you can compare VA to the 
private sector, and I really do not know what is going on 
there, but you really need to compare it against the standard 
of excellence that VA set for itself. And it was not doing the 
job.
    Mr. Walz. Yeah. Good point.
    And I think that, Dr. Petzel, you agree with that, too, 
because I think the question and the frustration coming from my 
colleagues is that whether it be communication or very 
disturbing to me with the dental incident of someone actually 
passing on information of poor practices, less than best 
practices and, yet, the appearance was not anything done about 
it.
    I think that frustration that the Chairman experienced 
asking, well, did you remove these people because there are 
barriers to doing that? I want to be very clear on that. Are 
our managers given the freedom to be able to make changes in 
due process with basic principles, but are they able to do 
that?
    Dr. Petzel. They are. The Civil Service rules are complex 
and complicated, but if you follow the right processes and 
procedures, it is possible to do that.
    I want to just make a comment about Dayton and the dental 
that has come up a couple of different times. And I want to be 
perfectly clear. That was a failure of leadership. That was a 
failure of leadership within the dental clinic.
    The people that worked with this individual knew that this 
was not appropriate. The technicians knew that it was not 
appropriate. The chief of dentistry knew that that was not 
appropriate. And for a long period of time, none of these 
people took the kind of action that they needed to take. And 
unquestionably that is a failure of leadership.
    Mr. Walz. I appreciate that. I appreciate all your work. 
And as I said, I am, of course, your biggest supporter, but I 
will also be your harshest critic until we get this down to the 
best anywhere. So I appreciate that.
    And I yield back.
    The Chairman. Mr. Johnson.
    Mr. Johnson. Thank you, Mr. Chairman.
    You know, as a former Air Force officer myself and as a 
veteran, I am very concerned about what I am hearing here. You 
mentioned several things. I heard earlier in your testimony or 
in response to one of the questions, you indicated that none of 
the technicians were permitted to write their own instructions, 
that there are standards to follow.
    I think you also expressed confidence in your oversight 
processes to catch these things. And just now to my colleague's 
questions, you talked about how everyone in Dayton knew that 
this was going on and that it was a failure of leadership.
    Which leadership are you referring to? Where is the 
failure?
    Dr. Petzel. I did not refer to everyone in Dayton knew this 
was going on. I referred to everybody in the dental clinic----
    Mr. Johnson. Right. Okay.
    Dr. Petzel [continuing]. Knew this was going on. And I 
think the primary failure there was the leadership in the 
dental clinic.
    Mr. Johnson. Okay. Well, let me refer you to a GAO report 
that came out today. The title of it says ``Weaknesses in 
Policies and Oversight Governing Medical Supplies and Equipment 
Pose Risks to Veterans Safety.'' Down in the oversight over 
reprocessing requirements, let me give you this quote.
    It says although VA headquarters receives information from 
VISNs on any noncompliance they identify as well as VAMC's 
corrective action plans to address this noncompliance, VA 
headquarters does not analyze this information to inform its 
oversight.
    Dr. Petzel, how can you express such confidence in an 
oversight process that does not even properly identify and 
analyze the information coming up through the system? And I 
submit to you that the failure in leadership is not just at the 
dental clinic. It is right here in Washington.
    Dr. Petzel. Well, first of all, Congressman, the issue in 
the dental clinic in Dayton was not one of reprocessing. This 
was one of infection control and the practices of a particular 
individual.
    Mr. Johnson. But aren't those covered under your oversight 
processes?
    Dr. Petzel. In a different manner than the reusable medical 
equipment, but, yes, there are some oversight processes 
associated with that.
    Mr. Johnson. Well, let me take just a second. Why GAO did 
this study, Department of Veterans Affairs' VA clinicians used 
expendable medical supplies, disposable items that are 
generally used one time, and reusable medical equipment, which 
is designed to be reused for multiple patients.
    And this GAO study looked at all of that. So they are 
looking at not only the reusables, but they are looking at the 
exposables and they identified serious weaknesses in the 
analysis and identification of the information that comes to VA 
headquarters.
    How do you respond to that?
    Dr. Petzel. We agreed with them and we agree that that was 
an appropriate thing to be doing and are now instituting a 
process to do that, to systematically look at the information 
we get to look for trends, to look for possible themes that run 
through those things. And we are now doing that. We agreed with 
them that that was a wise thing to be doing.
    Mr. Johnson. I guess I refer back to my colleague, Mr. 
Filner. You know, we have been talking about these things for a 
very, very long time. Why are we just now starting?
    You know, I met with a group last week, whether it is in 
the oversight of expendables and reusables or whether it is in 
oversight of the claims process, I met with a focus group that 
has identified glaucoma cases where patients, veterans have 
been identified with glaucoma and, yet, their referral for 
treatment took so long to get through the system that by the 
time it actually came up that they got treatment, it was too 
late and their condition was irreversible.
    And in the oversight and investigation arm of this 
Committee, I can assure you we are going to be looking into 
those as well.
    So how can we say that your oversight processes are even 
close to being adequate and why are we still talking about 
these things rather than doing something about them to protect 
the health and welfare of our veterans?
    Dr. Petzel. Well, Congressman, we have not just started 
doing this. We have been doing this for----
    Mr. Johnson. But that is what you just said. That is what 
you just said.
    Dr. Petzel. I said that particular----
    Mr. Johnson. You said we are now doing it.
    Dr. Petzel [continuing]. I said that particular aspect of 
the oversight is something that we are beginning to do early in 
2010.
    Mr. Johnson. My----
    Dr. Petzel. But the process of looking at RME, of improving 
RME, of oversight, of training, et cetera, these began quite a 
long time ago. And they have been continuously improved since 
our first instance of exposure possibly in 2008.
    Mr. Johnson [continuing]. My time is up, Dr. Petzel, and I 
am going to yield back, but I want to just summarize with this. 
And I agree with my colleague, Mr. Filner.
    If there is anything that it appears that the VA is expert 
in, it is talking around these problems and kicking the ball 
down the stream in a number of areas. We do not seem to get 
specific solutions to specific problems that greatly affect the 
health and welfare of our veterans. And that is a very 
concerning scenario to me.
    Mr. Chairman, I yield back.
    The Chairman. Mr. Reyes.
    Mr. Reyes. Thank you, Mr. Chairman.
    And thank you, gentlemen, for being here this morning.
    I wanted to ask if there was a way to compare what is 
occurring at the VA in terms of these particular issues, 
failings with whatever the standard might be on the civilian 
side or perhaps even in other systems similar to the VA even if 
we are considering other countries.
    I understand that my colleague, Mr. Walz, asked something 
similar, but I have to leave for a little bit and so I 
apologize for doing that. But I wanted to know if there is a 
basis for comparison about what is occurring at the VA.
    Dr. Petzel. Well, Congressman Reyes, there is and there is 
not. First of all, whatever, however we compare to the civilian 
sector, the fact that this happens to even one of our patients 
is not a good thing and needs to be changed and needs to be 
improved.
    So on the one hand, it is almost irrelevant how we compare 
to the private sector if we are allowing these things to 
happen. I think we need to address that directly in the ways 
that we are able to do this such as what is our disclosure 
policy like, how does our disclosure process work. We can 
compare that to what some private-sector people do. And ours 
compares very favorably.
    In terms of the incidents of this happening, it is not 
possible to compare it. And, again, I think that is irrelevant. 
The fact that it happens once is too often in our system and we 
need to be working in the direction of this not being able to 
happen ever again.
    Mr. Reyes. I understand.
    Dr. Petzel. It is very hard to compare. I just have to say 
it is very hard to compare.
    Mr. Reyes. Well, first, but my point is and you are right. 
Even one instance is one too many, but the reality is, and that 
is why we have lawsuits against doctors, against hospitals, 
sponges have been found stitched in after operations and 
scissors and all those kinds of things, the reality is that 
those kinds of things exist and happen in medical treatment.
    My point was if we are going to, are we in essence holding 
the Veterans Administration accountable realistically compared 
to other medical systems or are we in a situation where perhaps 
the VA needs to have an assessment, a self-assessment of the 
quality of healthcare that is going on because perhaps 
incidents are much higher than they would be in other kinds of 
systems?
    That was the point of my question. Yes, we can criticize 
you for every single misstep, but, you know, we all should 
strive for perfection, but the reality is perfection does not 
exist in the medical world just like it does not exist any 
place else.
    We are seeing the shuttle delayed by a week or so because 
of a mechanical problem. And that is in a system that is 
designed by all the checks and double checks and triple checks 
to be a zero defects operation. So that was the question that I 
had.
    Dr. Petzel. Congressman Reyes, I appreciate that. First of 
all, as the gentleman from the GAO said, we have to be held 
accountable for following the policies and procedures that we 
have out there. I mean, we should, number one.
    And number two is that whatever the comparison might be 
between the private sector, we need to again be held 
accountable for how we do. And I think that the goal has to be 
that we do not leave any surgical sponges in a patient's 
abdomen, that we do not fail in our reprocessing efforts with 
any piece of reusable medical equipment. I mean, that needs to 
be the standard against which we are judged, not necessarily 
what goes on.
    So I appreciate the concern and I appreciate the angst that 
people feel about the failures that we have, but I do not want 
to excuse those by saying that we are better than the civilian 
sector.
    We have to solve those problems internally by following or 
having the right policies and procedures, by following those 
policies and procedures, by having the kind of oversight that 
is necessary to assure us that is happening, and then, as you 
all have said repeatedly today, we need to hold people 
accountable if they do not follow those procedures.
    Mr. Williamson. If I could add to that, I think, Chairman 
Miller, you hit the nail on the head initially when you said 
that you could have all the requirements, you know, very good 
requirements, but if people are not following them, therein 
lies a problem. And let me just give you one example.
    In July of 2009, VA came out with a directive for its 
medical centers that said you shall have or you shall develop 
devicespecific training for your RME equipment.
    When we went into St. Louis in the fall of last year, they 
had not developed that kind of training requirements for 80 
percent of their RME. And that was 15 months after the 
directive came out and it was 6 months, we were in there 6 
months after the initial incident with the dental instruments.
    So I think, again, it is tough to compare the private 
sector with VA. I think VA in many cases had very good policy 
requirements and very good policies, but you have to get people 
to implement them.
    The Chairman. Thank you.
    Mr. Reyes. Thank you, Mr. Chairman.
    I was just going to ask perhaps the question that needs to 
be answered is, as we talk about accountability, how when 
issues like this come up, how they respond to it, not just with 
procedures, but accountability by the people that have been 
involved which, by the way, when Dr. Petzel mentioned, the 
Secretary has been in my district and I think Mr. Filner was 
there with us, his goal is to have the best available 
healthcare system on the planet, that has been articulated. We 
just have to make sure that there is accountability.
    Thank you.
    The Chairman. Mr. Runyan.
    Mr. Runyan. Thank you, Mr. Chairman.
    And thank you all on the panel for your testimony.
    I actually just chaired the DAMA Subcommittee hearing that 
the Chairman spoke about earlier. And I want to go back a 
little bit to what I ended up saying at the end. And I know the 
Chairman and several other of the Subcommittee chairmen have 
had meetings with Secretary Shinseki and we talked about 
accountability.
    The fact that we use the word oversight means there is a 
total lack of accountability. It really needs to leave our 
vocabulary because oversight means there was a mistake and we 
need to move on from that because we all agree to that fact.
    But going back to the dental scenario we were talking about 
that everyone knew was going on, have we made any steps in 
developing procedures and/or whistle blowing within that 
management team and moving in that direction to really stop 
something like that from happening because I think that is 
another place where I know people are afraid of stepping on 
toes of people senior to them?
    And I really think it needs to be addressed because 
obviously there is a situation where that did not need to be 
happening. I think if you had procedures and protocols in 
place, you could have avoided those situations.
    Dr. Petzel. Congressman Runyan, you make an excellent, 
excellent point. What is missing and what needs to be there and 
needs to be in all of our medical centers is what is developing 
in St. Louis and that is an atmosphere where people can come 
forward, as you said, to the management, to whoever they need 
to come forward to and say this is happening, this is wrong, 
somebody needs to look at it. And that did not happen at 
Dayton. And for a long time, that did not happen at St. Louis.
    There is very good evidence that things are changing in St. 
Louis. And my expectation is with the management team that is 
now in place in Dayton we are going to create that same kind of 
atmosphere.
    Not only do people need to be able to come forward, but the 
management team needs to be able to sit down and candidly 
discuss what is going on in the medical center to keep each 
other informed as well as hearing from what is coming up. And, 
again, just to reiterate, that was not the case at Dayton.
    Mr. Runyan. I think we can all totally agree on that. And, 
you know, my experience with dealing with higher powers is, you 
know, a lot of times, the truth hurts. And I think to be able 
to have that communication, open communication in a team is 
desirable no matter what team you are on.
    And you really have to make a push forward and just take 
the attitude of, you know, just the procedures that are in 
there, the standards that are in there, and, you know, the 
accountability you have personally to just get the job done and 
not worry about what my superiors are thinking but knowing that 
whether someone lower down has the backing of the Secretary who 
is going to blow the whistle, they need to be informed and 
assured that if they do blow the whistle on someone that it is 
not going to cost them their job and/or their career.
    With that, Mr. Chairman, I yield back the remainder of my 
time.
    The Chairman. Mr. Carnahan.
    Mr. Carnahan. Thank you, Mr. Chairman and Ranking Member 
Filner.
    You all have been on this issue. You both have been to St. 
Louis with a Missouri, Illinois bipartisan delegation and I 
appreciate your commitment to this issue.
    Also, I want to make really just a brief personal thanks to 
Phylicia Woods, who is LA on my staff, who is going to be 
leaving to go in the Peace Corps after this hearing. And I want 
to thank her for all of her great work for my office and for 
veterans in St. Louis, also the Veterans Advisory Committee 
that we work with in St. Louis who are back home watching this 
hearing today, and the many committed medical professionals at 
Cochran that are committed to reforming that institution.
    I spoke with Director Rema Nelson a little over a week ago. 
She described to me that they are working on a comprehensive 
turnaround plan, that they are working to incorporate many of 
these recommendations from the GAO and the Inspector General 
that can help this facility be what it needs to be for the 
veterans in St. Louis.
    My question for Dr. Petzel is, are you aware of this plan? 
We were promised to get a draft copy of it. By the end of last 
week, we have yet to receive that.
    But I think it is critical to turn that facility around, to 
have such a plan, to get buy-in from our veterans, our 
community leaders because we want them to succeed. But I think 
they have to have an aggressive plan to make that happen and 
they have not had it up to now.
    Dr. Petzel. Congressman Carnahan, I have not seen yet the 
plan. As soon as we finish from this hearing, I will get in 
contact with the director, Rema Nelson, and find out where it 
is. And if she has promised a copy of it to you, we will be 
sure that you get it.
    [VA subsequently provided the following information:]

          The St. Louis plan for the way forward was delivered by OCLA 
        on Tuesday, May 10, 2011.

    Mr. Carnahan. To me, that is critical point going forward.
    And to the point of reforming the adverse event disclosure 
procedures, we may have the best scientific procedures there 
are in the world, but if it does not reflect the human impact 
on veterans, it is not a good system. So we have to have the 
human side of that system in place.
    And to Mr. Filner's point, at the hearing in St. Louis, 
there was not a case management part of this in place. People 
in St. Louis, they got a cold form letter like a parking 
summons in the mail. That is it. And so that is when folks at 
the hearing said at the request from many people at that 
hearing that they would follow on and have the more personal 
followup.
    So I appreciate that that happened, but that is not where 
this started.
    Dr. Petzel. Thank you, Congressman.
    I will have to go back and review my recollection of it. I 
do know that we eventually ended up with case managers' phone 
calls in addition to the letters. And you may well be right 
that that occurred after the hearing. I just do not remember 
the sequence.
    Mr. Carnahan. I am right and that is the way it happened.
    Dr. Petzel. Okay.
    Mr. Carnahan. So we need to review it. That is the way it 
happened.
    Dr. Petzel. I will believe you.
    Mr. Carnahan. Anyway, the other thing, in light of the 
incidents at Cochran and other medical centers around the 
country, at what point is the management evaluated at these 
institutions and are they held accountable?
    Again, I am very pleased that the management of Cochran is 
developing this plan, but what we have heard from Dr. Daigh and 
others there have been repeated visits, citations, problems 
that have not been addressed starting with his work back in 
March of 2007, another visit and evaluation in August of 2008, 
May of 2009, March of 2010 and, of course, the Congressional 
hearing in July of last year. A lot of these problems are still 
lingering or not fixed yet.
    And, you know, the question is, how many times do our 
veterans have to fall in the same pothole before we fix it? And 
so I want to have this system in place. I want to have a 
comprehensive plan in place for Cochran. I want to get the 
community and veterans to buy-in, but at some point, people 
have to be held accountable if it is not implemented.
    Dr. Petzel. I absolutely agree with you, absolutely agree.
    Mr. Carnahan. Mr. Chairman, my time is up and thank you 
again. And I yield back.
    The Chairman. Thank you.
    Dr. Benishek.
    Mr. Benishek. Thank you, Mr. Chairman, Mr. Filner, and 
thanks for the panel here.
    I worked at the VA during the time of this colonoscopy 
event and I was aware that they shut the whole thing down. So 
it has some personal meaning to me.
    And I guess what I have found here is I guess you talked 
about this dental clinic a little bit, but are those people you 
identified here in your testimony, you know, the dental 
supervisors, the facility chief of staff, I mean, that dentist 
in question, I mean, did those people--have those people been 
punished or have they been fired or what exactly happened to 
those people?
    Dr. Petzel. I have to speak generically. The principal in 
question has retired. And there is no way that we can prevent 
somebody, even though we may want----
    Mr. Benishek. Right.
    Dr. Petzel [continuing]. To discipline them, from 
retiring----
    Mr. Benishek. What about the chief of staff?
    Dr. Petzel. The chief of dentistry I believe has resigned 
as well. And the chief of staff of that medical center, we have 
not yet determined what the situation is going to be.
    There are three administrative investigative boards going 
on right now as it relates to Dayton and we do not have the 
results of those yet.
    Mr. Benishek. All right. This is the kind of thing that is 
frustrating when there is, you know, a serious lapse of 
leadership that you mentioned, and, yet, you know, a 
significant amount of time has gone by and you have not decided 
what to do with this guy or gal.
    The other thing that disturbs me is Mr. Williamson's 
testimony about the 15 months elapsing between the, you know, 
the saying that you are going to be doing implementation of 
protocol for cleaning RMEs and then he reports that 80 percent 
of the--that has not been done in 80 percent of the places 
after 15 months.
    I would like to know who is responsible for that. I mean, 
who is the guy in charge of that, implementation of that 
process?
    Dr. Petzel. Just a comment. There were six medical centers 
that they reviewed out of 152. And I do not know where those 
medical centers were. If the GAO is willing to identify them, 
we would be delighted to go in and look and see what the 
problems were and what happened.
    Mr. Filner. Why didn't you ask them before this?
    Dr. Petzel. I beg your pardon?
    Mr. Filner. Why didn't you ask them to identify the medical 
centers?
    Dr. Petzel. I just got the GAO report.
    Mr. Benishek. Well, it is just frustrating to me to have--
you know, we have two agencies of the government here that sort 
of conflict. And, you know, Mr. Williamson seems to identify an 
area of leadership, that there is something wrong, where there 
is 15 months and now we--I cannot--how do I understand this 
information. You are saying one thing. He is saying another. 
And we are trying to decide how to best treat our veterans.
    I think we definitely need to followup on this, you know, 
from this Committee further and make sure that there is, you 
know, not only at the chief of staff level but higher up in the 
chain of bureaucracy, that we have effective leadership and 
accountability for those people at each of those higher up 
positions.
    Mr. Williamson, did you have a comment?
    Mr. Williamson. By the way, we went to Albany, Cheyenne, 
Detroit, Miami, Palo Alto, and St. Louis.
    You know, obviously we cannot travel to 90. And what we try 
to do when we go to a location is we look for systemic problems 
that transcend one facility. So while you only may go to a 
small number, you are verifying that something is missing 
throughout the system. So that is kind of the methodology that 
we use.
    I have to say that as most of the Members here who have 
been a recipient of GAO reports know, we have a very rigid and 
rigorous process for verifying our information. And all the 
things that I have told you in the report and in my opening 
remarks, VA has agreed with. We have an exit conference with 
VA. We give them 30 days to comment and so on. And we verify 
that pretty rigorously.
    So I do not think Dr. Petzel is disagreeing with the 80 
percent figure I used. I think he is probably coming from a 
different way. But, you know, accountability is our middle 
name. And so we are pretty careful, you know, about being 
right.
    Mr. Benishek. Well, thank you for your answer.
    I just want to try to follow up with this at a later date, 
so I do not lose track of this kind of information. I 
appreciate your comments and yield back the remainder of my 
time.
    The Chairman. I was just looking at a copy of the GAO 
report where there is a letter from Mr. Gingrich, Chief of 
Staff, saying VA has reviewed this report and appreciates the 
opportunity to comment on the draft.
    So VA had seen the draft, correct?
    Dr. Petzel. Just got it.
    The Chairman. You saw the report. This is talking about the 
draft.
    Dr. Petzel. Oh, the draft. Yeah, I am sure that it was 
reviewed here. I cannot recollect that I saw it, but, yes.
    The Chairman. You have not reviewed the draft?
    Dr. Petzel. I cannot recollect that I did. That does not 
mean I did not. I just do not know.
    The Chairman. If there was a report entitled ``Weaknesses 
in Policies and Oversight Governing Medical Supplies and 
Equipment Pose Risks to Veteran Safety,'' you would not 
remember that you saw it?
    Dr. Petzel. I might not, no.
    The Chairman. I hope you did. I hope you did or somebody at 
VA did.
    Ms. Wilson, you are next. Thank you for joining the 
Committee today.
    Ms. Wilson. Thank you, Chairman Miller and Ranking Member 
Filner.
    I am new to this and I inherited this from my predecessor, 
I am from Miami, Kendrick Meek. And so my following of this 
debacle was by reading the Miami Herald.
    And then my great Congresswoman Ros-Lehtinen invited me to 
a tour of the VA hospital and a meeting with the people there, 
with the administrators there, and then a press conference.
    And at the meeting, I was really shocked by the cavalier 
attitude of the administrator of the hospital and the way she 
was going about answering the questions.
    First of all, I found out that there were five people who 
contracted HIV-AIDS (acquired immune deficiency syndrome), HIV, 
eight hepatitis C patients, and one hepatitis B. We are not 
sure whether it was from the instruments or but they have it 
and they were tested with the unsterilized instruments.
    So my question to her was, where are these people now and 
what are they doing. And no one at that meeting had an answer. 
No one could tell us what was happening with these particular 
patients who were infected.
    So I asked them to assign one person from the hospital to 
be in charge of, sort of like a case worker, to make sure that 
they were being treated, that they were following up with it, 
and to get back to us and let us know what was happening.
    So we got a letter saying that they had followed up with 
all of them except four. And they could not find these four. 
And they could not find the--they could not--four were--came in 
for one treatment and then--I mean, two and then two they could 
not find at all.
    So my concern was that these two people, and they did not 
identify which two they were, they did not identify which 
malady they contracted from the hospital, and I am just 
wondering for their safety and the safety of the public is 
there any way that we should include the Florida Department of 
Law Enforcement (FDLE) or the Federal Bureau of Investigation 
(FBI) or the local authorities to try to find these people, 
even private investigators, so that they would know that they 
are infected and they, in fact, should have the opportunity for 
treatment. That is the first question.
    The second question has to do with Ms. Berrocal who is the 
woman that was in charge of the hospital. It is my 
understanding when this debacle first occurred she was 
reassigned and someone from Jacksonville took her place.
    Before she was put back into her place at Miami Hospital, 
there was supposed to have been a report and some sort of 
evaluation that was supposed to be released before she was sent 
back to her position.
    She was sent back to the position. There was no report 
done. The Miami Herald, through a public records request, asked 
for this report and to date, they still do not have it. And she 
is still there.
    Are you aware of all of these circumstances at the Miami 
Veterans Hospital?
    Dr. Petzel. I am aware of them, Congresswoman. There was a 
report. And Ms. Berrocal is back at the Miami VA Medical 
Center. I do not recollect the specifics of what was in the 
report, but we can certainly resurrect that and see.
    I would say that I think that Congressman Ros-Lehtinen and 
others would agree that Miami is really beginning to turn 
around, that the atmosphere and the practices of that hospital 
are really quite improved over what they were when we 
originally had the colonoscopy incident several years ago.
    Ms. Wilson. My question has to do with finding the patients 
who are unaccounted for. What can we do to find them at this 
point?
    Dr. Petzel. That is a good question. And I honestly do not 
know. I know that the medical people follow up. I do not think 
that they use private investigators, the police, or the FBI. 
That is certainly something that we can look into if we still 
are not able to contact those last two patients. And we will 
look into that.
    Ms. Wilson. Okay.
    The Chairman. Thank you, Ms. Wilson.
    I would like to use the Chairman's prerogative if I would 
and beg the indulgence of the Committee Members. And since we 
are dealing with Miami, which Ms. Wilson has been talking 
about, I would like to go ahead and recognize Chairman Ros-
Lehtinen if she would to continue the questioning regarding 
Miami.
    Ms. Ros-Lehtinen. Well, thank you so much, Mr. Chairman and 
Mr. Filner. Thank you for your leadership on this issue that 
has been ongoing. It is so frustrating for so many of us. And 
Mr. Under Secretary, you said you are doing better, but you 
continue to find patients who were not notified in Miami, 12 
additional names this past December. You state that excellent 
way of notifying industry standards, those kinds of phrases.
    And while I am happy that the VA is making efforts to 
reform its procedures in the area of reusable medical equipment 
and in notifying at-risk patients, we have been down this path 
before. We are so frustrated. Ms. Wilson, Mr. Rivera, Mr. Diaz-
Balart and I.
    In 2009, the Miami VA, as you know, notified over 2,400 
veterans that they may have been at risk for infectious 
diseases. Then a year later during a review of the VA's 
facility logs, a year later an additional 79 veterans were 
discovered to have been at risk. And now just this past 
December where Ms. Wilson was talking about another 12 names 
were discovered in an third review. Of these veterans, 17 have 
been tested for HIV hepatitis B or C. It doesn't mean that it 
is cause and effect, but it is very alarming. So over these 3 
years, the list has kept growing.
    Members have previously sat in this very Committee room, 
were assured by VA that the Administration was taking action to 
correct this previously failed policy. This has not happened, 
those steps have not been put into place.
    The VA Central Office initially left it up to the Miami VA 
to identify at-risk patients, and I would like to ask these 
questions.
    Will another review, if we were to do another review, find 
more at-risk patients? What degree of confidence do we have 
that every time you have done a review you have found 
additional folks who have fallen through the cracks? I don't 
have confidence that the entire pool of at-risk patients have 
been identified.
    Secondly, are there now oversight mechanisms in place at 
the VA Central Office where an independent authority will take 
charge and make certain that a local VA like Miami will 
meticulously review patient files to identify those who require 
notification? Or is the attitude of the Central Office things 
are going well, patients are being identified, and all systems 
go?
    And number three, so here we are again, Members are being 
told that the VA has taken steps to eliminate the problems from 
the VA centers, and if additional names are found or if it is 
discovered that facilities continue to use improperly 
sterilized equipment what then? What steps will be taken?
    And I share Congresswoman Wilson's frustration. We have had 
so many meetings about the follow up, and I remember the first 
meeting that we had, and that was with her predecessor, Mr. 
Meek, and we made this oh so brilliant suggestion that perhaps 
they could go door to door and knock on the veteran's home, 
apartment, wherever the veteran is, and they said, oh, that is 
a good idea. And we are just so brilliant that way. And so they 
said, okay. So they got back to us and they said, yes, we have 
knocked on the doors. And then we kept asking, okay, of those 
you have identified and you have knocked on their doors, have 
each of these veterans been informed that they can get 
treatment? Have they turned the treatment down?
    And I understand that there are privacy concerns. We are 
not asking for their names and their addresses, but they cannot 
tell us, at least they haven't told us. They have not told us 
this is the pool, these have been notified, these are under 
care. We have no degree of confidence that they are in fact 
getting care. We don't have to force someone to get care, but 
we are talking about community health problems if these 
veterans don't get the care.
    So it is not just that veteran, it impacts the entire 
community. You can't force them to get care, but you can 
certainly work with that veteran to have that veteran 
understand how serious this is, how it can impact the 
community, and let us know that those veterans are indeed 
getting care.
    But I want you to understand how frustrated we are that we 
have these meetings once and again and again, and honestly we 
are saying this is water, and they will say, oh, okay this is 
water, and it is very patronizing to us, because we know that 
they must know more. I pray that they know more than they are 
telling us. I pray that the veterans are getting the treatment 
that they are getting, but they are not telling us.
    So, I would like to say, with a degree of confidence, to my 
constituents this problem really has been worked out after all 
of these years, but I don't have that confidence, but I thank 
Ms. Wilson for everything that she has been doing and Mr. 
Rivera, Mr. Diaz-Balart, we are all united, we have a very 
united delegation on this, and I thank the Chairman and the 
Ranking Member for being such fearless leaders on this.
    I would like to see if you could answer those questions. 
Are we going to do another review in Miami? Do you have a 
degree of confidence that every at-risk individual has been 
identified, that there has been some followup care, that 
everything really is what it should be? And if it turns out 
that it isn't what then?
    Thank you, Mr. Chairman.
    Dr. Petzel. Thank you Congresswoman. I can answer those 
questions. First let me start with the last.
    We can provide you with information. Again, not specific 
names, but about the number of people that have been contacted, 
the number of people that are under care, and that is available 
and we will certainly get that to you.
    The second thing is when they are notified part of that 
notification involves one of the consequences of this potential 
exposure and what are the remediations so that if somebody 
feels as if this indeed was the cause of their contracting HIV 
or hepatitis C they have a legal remedy, and every single 
person that we notify that is positive is told about that legal 
remedy.
    In terms of the----
    Ms. Ros-Lehtinen. And let me ask you, when you say that we 
can get you that, that is the same thing that happens to us 
when we meet with them. They will say they can get it to us as 
if we were meeting on what to order for lunch. I mean that is 
the purpose of our meeting, so that is the information we want, 
and then after every meeting they say we will get you that 
info, so that is the purpose of what we want. All of those 
individuals without any names where are they getting care?
    Dr. Petzel. We can get that to you within a week.
    The second question involved the process and how certain am 
I that we have identified and notified everybody. And I am as 
certain as I am going to be, that we have done that.
    We learned a lot in the Miami process, just to reiterate. 
Initially that was the identification of who should be notified 
was the responsibility of the facility, and they made a 
decision to use a computerized medical record and the coding 
that was in there to identify the people that had 
colonoscopies. It was found out several months, almost a half a 
year, after that notification someone called up and said, I had 
a colonoscopy during that period of time but I wasn't notified.
    So there were some errors, if you will, in the coding that 
occurred that went into the computerized medical record. That 
was the second iteration.
    And then the third iteration had to do with a logbook that 
shouldn't have been there but was used and had in it again 11 
patients that weren't on the computer list because those 11 
patients had been inappropriately coded when they went into the 
computer list.
    But the primary lesson we have learned here is that we have 
a Central Office team now that does the process of identifying 
who should be notified.
    This event is something that occurs hopefully once in the 
lifetime of a medical center. They have no experience in 
developing the material that you need to get a list, so we have 
now made that a Central Office function.
    We send a group of people down who have experience doing 
this and have done this in other circumstances and they have 
become responsible for developing the list of people that need 
to be notified.
    Ms. Ros-Lehtinen. Thank you. And Mr. Chairman, just one 
last note. The Miami Herald, Fred Task, has been doing an 
excellent job on this and I hope that he would not need to file 
another Freedom of Information Act to get information about 
these vets. I would hope that you would share information with 
our community, not names and addresses, but what is new on the 
status. It is a big concern with them.
    [The VA subsequently provided the following information:]

          Of the 17 patient positives, one (1) expired from other 
        causes. One (1) patient is currently being followed and treated 
        at a VA Medical Center in Arkansas and was last seen on April 
        9, 2011. One (1) patient is currently being followed by his 
        private physician in the Miami area. The remaining fourteen 
        (14) patients are being followed by the Miami VAHS. Of those, 
        eleven are actively receiving care. The remaining three 
        patients have not responded to VA's outreach efforts. We will 
        continue to make sure that they are aware of our services and 
        remain available to treat them if they choose VA care.

    The Chairman. Thank you, Madam Chairman. Mr. Clay.
    Mr. Clay. Thank you, Mr. Chairman, thank you for conducting 
this hearing.
    Let me personally thank you and Mr. Filner as well as the 
Committee staff for giving the time and attention to the issues 
that have arisen over the last year or more at Cochran VA 
hospital in St. Louis in my district.
    Let me start with Dr. Daigh or Mr. Williamson. Have the 
sterilization problems in the dental clinic at John Cochran 
hospital been resolved?
    Dr. Daigh. Yes, sir, I believe they have.
    Mr. Clay. Thank you. You think they have.
    Okay, now what was the final source of the contamination in 
the surgical unit? What was the cause? Can either one of you 
speak to that? Or can you, Mr. Petzel?
    Dr. Petzel. I think I can. I don't believe, Congressman, 
that they have had any experience with that, and I assume that 
you are referring to the fact that there was some discoloration 
discovered on surgical instruments by one of the scrub nurses, 
and we then stopped surgery in St. Louis while we tried to 
discover what that discoloration was.
    There was not a sterilization problem or an issue, those 
instruments were sterile, and eventually we came to the 
conclusion that it was a combination of events; the fluid that 
was used in pre-wash and the filters on the steam sterilization 
unit. When the solution was changed and when the filters were 
changed we were able to get rid of the discoloration and that 
started up again.
    This is something that we discovered and I think was 
managed quite well.
    Mr. Clay. Okay, Doctor, was that a vendor issue or was it 
inside the hospital?
    Dr. Petzel. Well, it was inside the hospital insofar as the 
instruments were being sterilized in the hospital, but again, 
it had to do apparently to the fluid that was being used and to 
the filters in the sterilization.
    Mr. Clay. Which caused the spots on the instrument.
    Dr. Petzel. Which caused spots on the instrument, correct, 
discolorations, but not an issue of sterilization.
    Mr. Clay. Okay. Let me ask you, why does Cochran VA Medical 
Center consistently receive a low patient satisfaction when 
compared to other VA facilities, and why does this problem 
persist year after year?
    Dr. Petzel. Let me take a few minutes to explain this.
    Mr. Clay. Go right ahead, I have a little time here. Go 
right ahead.
    Dr. Petzel. When you look across the country inside or 
outside the VA wherever you have customers, wherever you have 
patients the satisfaction of the individual patients with their 
care is a direct reflection of employee satisfaction. There is 
a very, very strong relationship. If you have a satisfied 
workforce that enjoys their job and is doing it, you know, with 
a smile, so to speak, you are going to have generally speaking 
a group of patients that are going to also feel good about 
their experience.
    And I think there was a history at John Cochran, again 
before my time, where we had an employee group that was not 
particularly satisfied or happy in the workplace.
    Mr. Clay. Now wait a minute, let me stop you. That tells me 
as a cultural issue----
    Dr. Petzel. Absolutely.
    Mr. Clay [continuing]. In that facility.
    Dr. Petzel. Absolutely.
    Mr. Clay. Have you addressed it and how?
    Dr. Petzel. I believe that we are addressing it. Rema 
Nelson, the new director there has created a much more open 
atmosphere where people can talk to her about problems, she is 
approachable, she is out walking around that hospital 
continuously testing the waters, taking the temperatures, 
seeing how things are happening.
    We hear now from the union and from the service 
organizations that the atmosphere there has changed, that this 
is a better place to work, a happier place to work.
    My hope and expectation is that this is going to be 
reflected in the patient satisfaction scores.
    Mr. Clay. When will we know that?
    Dr. Petzel. Every month we do a series of inpatient and 
outpatient satisfaction scores, so I am hoping relatively soon. 
I don't know how long. I don't know how long, but I am hoping 
relatively soon we will see a change.
    Mr. Clay. Okay, my concern is this, Doctor. If we cannot 
improve conditions perhaps it is time for the St. Louis region 
to try perhaps a voucher system for patients to receive medical 
attention from our two world-class medical facilities that are 
a stones throw away from the VA Cochran.
    If you cannot do the job for these people that deserve it, 
perhaps we need to look at another system to deliver medical 
care to them.
    Dr. Petzel. My expectation is that we are going to see 
improved patient satisfaction scores at the John Cochran.
    Mr. Clay. As soon as you receive it share that with us.
    Dr. Petzel. We absolutely will.
    [The VA subsequently provided the following information:]


              Patient Satisfaction at St. Louis VAMC, 2011
                  National Satisfaction Scores (SHEP)*
------------------------------------------------------------------------
              INPATIENT SATISFACTION                      2011 (%)
------------------------------------------------------------------------
John Cochran                                                       42.3
------------------------------------------------------------------------
Jefferson Barracks                                                     Cases too low
------------------------------------------------------------------------
  Overall                                                          42.3
------------------------------------------------------------------------



------------------------------------------------------------------------
              OUTPATIENT SATISFACTION                     2011 (%)
------------------------------------------------------------------------
John Cochran                                                       54.7
------------------------------------------------------------------------
Jefferson Barracks                                                 40.3
------------------------------------------------------------------------
  Overall                                                          49.1
------------------------------------------------------------------------
Because of the time lag between the time of care and the survey report,
  the FY 11 scores reflected here only data from October through
  January. Until second quarter data is obtained a comparison between FY
  10 and FY 11 is difficult due.


    Quick Card

          In order to provide some real time information on customer 
        satisfaction, the Medical Center has implemented a Quick Card 
        survey system. Here are the results of the Quick Card surveys 
        from December 2010 through April 2011:


------------------------------------------------------------------------
         QUICK CARD QUESTIONS  (yes / no)            YES RESPONSES  (%)
------------------------------------------------------------------------
Courtesy of Staff                                                    97
------------------------------------------------------------------------
Timely Service                                                       88
------------------------------------------------------------------------
Experienced Delay                                                    25
------------------------------------------------------------------------
Facility Appearance                                                  94
------------------------------------------------------------------------
Professional Appearance of Staff                                     97
------------------------------------------------------------------------


    Mr. Clay. Thank you. Thank you, Mr. Chairman, and I yield 
back.
    The Chairman. Ms. Buerkle.
    Ms. Buerkle. Thank you, Mr. Chairman, and thank you to you 
and to Ranking Member Mr. Filner for your taking the lead on 
this issue, very important issue, and thank you to our panelist 
today.
    I am Chairman of the Subcommittee on Health. I am a 
registered nurse and I also am an attorney and I represented a 
major teaching hospital for many years, so this is all of very 
particular interest to me.
    I think the first thing that concerns me is when we refer 
veterans to our healthcare veteran facilities that they have 
some sense of what Dr. Roe mentioned, trust, and that we are 
referring them to a system that will take care of them, and at 
the very least that care should be what the industry offers.
    I think you are all familiar with JCO, every hospital 
hunkers down when The Joint Commission comes in and reviews all 
of the processes, every system, every process, and they hold 
the hospital accountable and everyone prepares for that and 
there is that accountability factor.
    So I guess my first question, Dr. Petzel, is what in the VA 
system is analogous to the JCO reviews that a hospital has to 
undergo every few years?
    Dr. Petzel. Well, Congresswoman, first of all we do undergo 
the Joint Commission reviews just like everybody else, so our 
hospitals are all accredited by the Joint Commission.
    Number two, and the process has changed recently insofar as 
now you don't know when they are going to come, and what 
happens is what we call continuous readiness. That is you have 
to be ready for them to drop in at any moment. They do not 
announce that they are coming and they show up at your doorstep 
on a Monday morning or a Tuesday morning and begin their 
survey.
    It is a tremendous improvement from my perspective, because 
previously we all dropped everything for 6 months before the 
Joint Commission came and cleaned the floors and uncluttered 
the hallways and did all those sorts of things and now you have 
to do that all the time, which is the way it should be.
    We also have the SOARS process, which is an internal within 
the Veterans Health Administration (VHA) process of inspection 
that occurs. The OIG does their Combined Assessment Program 
reviews. Every 3 years they go to every facility and are much 
more thorough than the Joint Commission in terms of oversight 
and looking at us. And those are probably our two biggest VA-
related internal reviews like the Joint Commission.
    Ms. Buerkle. Well, then how do situations like these occur 
with that kind of oversight, with that--kind of what happens 
that these situations--the VA finds themselves in these 
situations? Any private hospital would have corrected it, it 
wouldn't happen again. And these instances continue to occur. 
And if you have this oversight in place why aren't corrections 
being made?
    Dr. Petzel. Well, at each one of the medical centers, 
Congresswoman, that are involved those corrections have 
occurred. We don't have a recurrence of any of these incidents 
at any of the medical centers that were--of these four that we 
have been discussing. They have cleaned up their act, they have 
changed their practices, and they are doing the things that 
they need to do to appropriately sterilize the equipment.
    I think that why this has happened in our system, we are a 
national integrated system, everybody should be aware of what 
is going on, and I think again there is a failure of 
leadership, people not holding other people accountable, people 
not checking to be sure that indeed everybody does have 
training in the SPD, indeed everybody does do their job. We are 
supposed to watch somebody do their training, and I think when 
these things break down it is a failure of those things to 
happen. It is again a failure of leadership.
    Ms. Buerkle. I would submit that if it is happening in any 
of the VA hospitals and it hasn't been corrected we are looking 
at a hospital system, and so the policies and procedures should 
apply to all. So if there is a problem here that correction 
should take place in all of the hospitals, and apparently that 
hasn't been done.
    Dr. Petzel. And I absolutely agree with you, Congresswoman, 
that is absolutely the way this system should work.
    Ms. Buerkle. Just briefly in my few seconds that I have 
left. When we look at medical malpractice, the question is also 
asked what is the deviation in the standard of care, and that 
is how we gauge whether or not there is malpractice.
    What is the standard of care that the VA hospital, what 
standard of care would you be adhering to? Which one standard 
of care? I hear lots of different oversights, but what is the 
standard of care you apply?
    Dr. Petzel. I am sorry, Congresswoman, I don't quite 
understand the question.
    Ms. Buerkle. Well, I assume the VA hospital adheres to one 
set of processes and one set of procedures based on something, 
and whether it is JCO standards or what--it sounds to me like 
it is rather arbitrary.
    Dr. Petzel. First of all sort of at the top would be the 
Joint Commission standards. We are again accredited by the 
Joint Commission, every one of our 152 medical centers and 871 
outpatient clinics have that accreditation, so that would be 
one standard.
    Second, we have policies and procedures that are much more 
specific than what the Joint Commission would be looking at for 
many, many things, and we adhere to those standards.
    And I think we would not get argument either from Dr. Daigh 
or Mr. Williamson about our policies and procedures. We have 
good policies and procedures that are at the top. The problem 
is adherence to those policies and procedures. The problem is 
our people following those policies and procedures.
    So I am not as concerned about the standard that we are 
setting as I am about are we adhering to that.
    Ms. Buerkle. I am out of time. Would the Chairman just 
allow one more question?
    The Chairman. Very short.
    Ms. Buerkle. Dr. Daigh, would you agree with what Dr. 
Petzel is saying?
    Dr. Daigh. Yes, ma'am. I believe VA has really quite 
excellent policies and procedures that are in most cases 
industry standard and often put together with the use of 
experts who spend part of their time at VA facilities and part 
of their time at the various universities. So much of the staff 
at the VA is medical school plus VA, so I think their policies 
are correct.
    As I indicated in my statement, I think the issue is 
execution, that is doing what you are supposed to do every day.
    Ms. Buerkle. Thank you, Mr. Chairman.
    The Chairman. Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman. I want to thank the 
Chairman and the Ranking Member for their tenacity on this 
issue, but I particularly want to thank the Chair.
    Chairman Miller has taken a particular interest in these 
issues. His care for veterans has been evident throughout his 
work on this Committee, but in these instances where these 
specific infractions came to light Chairman Miller has dived 
in, he came to my community and has personally read all the 
documents that are involved, and I want you to know that if it 
hadn't been for Chairman Miller, I don't think my community 
would even have the information that it has today.
    The VA has stone-walled my community, they have not been 
responsive. If it wasn't for this Committee beginning to force 
the VA to work with my community, I honestly believe that we 
would have even less than we have today.
    Mr. Petzel, you said this is unquestionably a failure of 
leadership. Then when you were asked about accountability for 
that leadership, what happened to those people who would have 
been that failed leadership, you really didn't know what had 
happened to the people in this chain.
    We have in my community a dentist who for almost 2 years 
violated the standard care of practice, not sterilizing 
equipment, taking things from people's mouths, using the same 
gloves the entire day while working on people, not cleaning 
instruments and tools that he used on numerous people, and this 
isn't something that was going on for a couple decades in 
secret, it was visibly obvious, it was in a clinic that it 
occurred, that was located directly above the director's 
office. This wasn't even in an isolated, located facility away 
on campus. This is something that was known.
    So when you say failure of leadership I agree. The dentist 
in question though got to retire, the Chief of Staff got to 
retire, the director was promoted.
    So if it is leadership, if we go up the chain of command 
where it goes from the patient to the dentist to the chief of 
staff to the director no one has been held accountable. So we 
have a failure of accountability.
    We also have a failure of being able to complete an 
investigation. The OIG was unable to talk to the dentist in 
question because he retired, or the chief of staff, or even the 
complainants because the people having left the system. So we 
don't have accountability and we don't even have the ability to 
do a complete and total investigation.
    The review that was undertaken by the VA was pretty much 
done in secret. The review board that the VA empanelled and 
even the testimony that was taken when it was released to the 
community, the names of all the individuals were redacted, and 
they were redacted so we wouldn't even know who it was that you 
were relying on to review what had occurred in advising the VA 
as to what patients to be notified or even what their care was 
supposed to be.
    I contacted the Greater Dayton Hospital Association for my 
community, your regional peers, and I asked them to review what 
you did provide the community. They provided a report basically 
saying one, that all of the information needs to be released. 
There is a number of documents that are really critical for our 
community to understand whether or not you are taking 
appropriate precautions for those that were subjected to a risk 
of HIV and for hepatitis.
    Secondly, they disagree with your scope of the patients 
that are notified. They believe that many more people were 
subjected to exposure to HIV and hepatitis, and so they have 
asked for in addition to an expansion of the documents that are 
released for additional patients to be notified.
    Now I appealed your redacting of the documents that were 
provided to us. I was told that you wanted to protect those who 
were part of the review board so they would not be subject to 
harassment.
    You know in our court system we don't let juries stand 
behind a screen. We require that they be held accountable to 
the community for what their decisions are on things that are 
very, very significant judicially and to people's lives.
    There is no reason why you should be empanelling review 
Committees that are then done in secret, that we all then have 
to guess as to what their motives were, their backgrounds, 
their experience, or their basis for their determination.
    When I asked for the non-redacted version to be released, 
you answered that even the dentist's name in question should 
not be released because of the nature of the investigation and 
seriousness of the allegation, the dentist could be subject to 
harassment or worse. You actually indicated that you didn't 
want to release it because he could be subject to annoyance or 
harassment. Annoyance or harassment like being subject to the 
risk of HIV and hepatitis? I mean this is incredibly serious, 
and the VA is not being open with my community or I think even 
giving an ability for proper oversight from Congress.
    I have three questions for you. You said this is a failure 
of leadership, now we are going to come to the issue of your 
leadership.
    Are you willing to expand the number of patients that were 
notified, tested, and received treatment as a result of the 
actions that occurred at the Dayton VA? Are you willing to 
release the documents that were requested by our Greater Dayton 
Hospital Association so that they can review your investigation 
to these practices? And are you willing to release the non-
redacted review transcript from your review board so that we 
can actually evaluate your approach on this issue?
    Dr. Petzel. In answer to the first question, we are and 
will go back and look at the process that we went through in 
terms of identifying the patients that needed to be identified.
    At this present time I stand by the decision that the 
clinical review board made as to who should be notified, but we 
are going to look at that.
    Number two is that we have made available to the Committee, 
to the Chairman all of the material that they request. We 
cannot release some of this material to the Greater Dayton 
Hospital Association. We cannot release----
    Mr. Turner. Sir, hold on a second. I know my time is brief, 
but if you would permit it, Mr. Chairman.
    I have the documents of the Freedom of Information Act 
provisions that you are standing on, they are all 
discretionary, and when I was briefed by your staff in my 
office they admitted it was discretionary. So please don't say 
that you cannot release them, because of course you can. There 
is no patient information that is being protected here, because 
no patient information is included in what is been being asked. 
It is procedures, policies, and actions.
    Dr. Petzel. I am sorry, Congressman, but I have been told 
by our attorneys that we cannot release to you, or to the 
community, those unredacted documents.
    Mr. Turner. Okay. Well then they were in my office, your 
attorneys by the way, if you and I meet in my office with your 
attorneys and your attorneys say that it is discretionary does 
that mean that you are willing to release them? Because you are 
not prohibited from releasing them.
    Dr. Petzel. If they tell me that they are releasable----
    Mr. Turner. That it is discretionary.
    Dr. Petzel. Beg your pardon?
    Mr. Turner. That it is discretionary within your discretion 
you will use that discretion and release them.
    Dr. Petzel. I would have to then consider doing that, but 
that is not what I have been told.
    Mr. Turner. You are not required to maintain the redaction 
and you may release those documents.
    So I would expect that you would use that discretion that 
you have and release them based upon your testimony today.
    And then my third question. You were answering on the 
redaction and the release of the documents. Is it combined, 
both on the issue of redaction and release the documents?
    Dr. Petzel. Correct.
    Mr. Turner. Okay. Thank you. Mr. Chairman, thank you for 
your work on this.
    The Chairman. Thank you, Mr. Turner. Mr. Bilirakis.
    Mr. Bilirakis. Thank you, briefly. Thank you, Mr. Chairman, 
I appreciate it.
    Question for the panel. Should a person acquire an 
infectious disease and it is a result of a mistake by the VA 
health system, what resources are available to that individual 
besides the legal remedies that you mentioned?
    Thank you.
    Dr. Petzel. That is an excellent question, Congressman.
    First of all you can never establish for sure that it was 
associated with the event or that it wasn't associated with the 
event. The assumption has to be that if they had a colonoscopy 
with what was felt to be an unsterilized colonoscope and 
developed hepatitis C that that was responsible, so we assume 
the responsibility for anybody that is converted.
    Two things are fundamentally available. They are eligible 
for and will receive healthcare from us for as long as they 
need it for the rest of their lives if that may be the case. 
Two, is that they have a legal remedy insofar as they could 
file what we call a tort claim and recover damages if the court 
indeed believes that there is a relationship between our event 
and their disease.
    So healthcare on the one hand, compensation on the other.
    Mr. Bilirakis. Does it require filing a lawsuit to receive 
any sort of compensation?
    Dr. Petzel. In most instances, yes, but let me ask one of 
the people here with me. I think that we may be able to 
service-connect somebody who develops a disease because of 
something we did. Is that correct? They believe so. Let me get 
back to you specifically about that.
    Mr. Bilirakis. Okay, please do.
    Dr. Petzel. I will.
    [The VA subsequently provided the following information:]

          The statutory provision at 38 U.S.C.  1151 authorizes 
        payment of compensation for additional disability or death that 
        is not the result of the Veteran's willful misconduct and is 
        caused by hospital care, medical or surgical treatment, or 
        examination furnished to the Veteran under laws administered by 
        VA. To meet the qualifications of 38 U.S.C.  1151, the 
        proximate cause of additional disability or death must be:

            Carelessness, negligence, lack of proper skill, 
        error in judgment, or similar instance of fault on the part of 
        VA in furnishing the hospital care, medical or surgical 
        treatment, or examination; or
            An event not reasonably foreseeable.

          VA may pay compensation under 38 U.S.C.  1151 for disability 
        resulting from hepatitis B and C, as well as HIV, if there is 
        competent medical evidence of record showing that these 
        conditions were proximately caused by either carelessness, 
        negligence, lack of proper skill, error in judgment, or a 
        similar instance of fault on the part of the VA in furnishing 
        hospital care, medical or surgical treatment, or examination.

    Mr. Bilirakis. Thank you. I yield back, Mr. Chairman. Thank 
you.
    The Chairman. Mr. Filner.
    Mr. Filner. Let me just go back to my original statement, 
Dr. Petzel.
    Again, you have said over and over that again that it is a 
failure of leadership, and yet again, I think it is more 
bureaucratic defensiveness and secrecy. We don't know that 
there has been accountability.
    I think we need to work with you and your lawyers to 
develop a new way to give us some assurance these issues are 
being handled. What you have given us today gives us very 
little confidence that these personnel decisions are being 
handled with some accountability. You gave us three examples of 
something happening, mainly retirement, or I forget what you 
called them. Three employees for all these years of problems?
    Whether we can sit in executive session as a Committee and 
talk to you about that, I don't know. I think we have to 
examine that, Mr. Chairman.
    We need a new process here because you are standing on 
Civil Service protections, you are standing on secrecy, you are 
standing on legal matters, and yet I don't care what the 
private sector does, this is a public institution. We have to 
get trust and confidence in a different way. The same legal 
remedies are not available to someone with regard to a public 
system any way. But I think we need to have a discussion about 
how we do this. This is very, very unsatisfactory.
    If you could tell us more and we could get more in a 
setting with, perhaps, just the Chair and the Ranking Member of 
either the whole Committee or a Subcommittee Executive Session. 
We need to figure out a way to get a better handle on this 
stuff, because we can't tell our constituents anything because 
we don't know anything. Even if we knew something it would help 
us to have confidence, and know it has been taken care of. I 
can't say that to anybody right now.
    So you need to find a way to give us the confidence to give 
our constituents, and we would be happy to work with you. We 
need a new way to do this and it is just not working the way it 
is.
    Thank you, Mr. Chairman.
    The Chairman. I thank you very much. Are there any other 
questions of the Committee?
    I thank the panel for being here today. There probably will 
be some questions that will be sent for the record. We thank 
you for your testimony.
    If the second panel will begin coming forward. We have two 
more witnesses here to be with us today. Dr. Michael Bell, he 
is the Deputy Director of the Division of Healthcare Quality 
Promotion for the Centers for Disease Control and Prevention 
(CDC), and Mr. Anthony Watson, Director of the Office of Device 
Evaluation of the Centers for Devices and Radiological Health 
for the Food and Drug Administration (FDA).
    We thank you both for sitting through the testimony from 
the first panel and the questions. We thank you for being here 
today.
    As you have witnessed, the patient safety incidents at VA 
medical centers are complex and have wide ranging implications. 
I look forward to hearing from you today on how we can take a 
comprehensive proactive approach to patient safety for our 
veteran heroes and for all Americans.
    So with that, Dr. Bell, you are recognized for 5 minutes.

STATEMENTS OF MICHAEL BELL, M.D., DEPUTY DIRECTOR, DIVISION OF 
 HEALTHCARE QUALITY PROMOTION, CENTERS FOR DISEASE CONTROL AND 
 PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND 
     ANTHONY D. WATSON, BS, MS, MBA, DIRECTOR, DIVISION OF 
ANESTHESIOLOGY, GENERAL HOSPITAL, INFECTION CONTROL, AND DENTAL 
 DEVICES, OFFICE OF DEVICE EVALUATION, CENTER FOR DEVICES AND 
    RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, U.S. 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

                STATEMENT OF MICHAEL BELL, M.D.

    Dr. Bell. Good afternoon Chairman Miller, Ranking Member 
Filner, and other distinguished Members of the Committee. I am 
Dr. Michael Bell, Deputy Director of the Division of Healthcare 
Quality Promotion at the Centers for Disease Control and 
Prevention.
    Thank you for this opportunity to discuss the important 
topics of preventing healthcare associated infections and 
ensuring safe healthcare nationwide.
    Healthcare associated infections are infections that 
patients get while receiving care. These infections range from 
those related to highly specialized intensive care procedures 
down to infections caused by lapses in the most basic safe 
practices, for example, reusing disposable syringes.
    CDC estimates that roughly 1 in 20 hospital patients have 
healthcare associated infection. These infections are often 
severe and can kill people, and in hospitals alone they result 
in an estimated $26 to $33 billion a year in excess costs. 
Fortunately we know how to protect patients from many of these 
infections, and if we can protect them then we must protect 
them.
    Healthcare associated infections can occur in any 
healthcare setting. These settings include hospitals, dialysis 
centers, ambulatory surgical centers, and nursing homes.
    Medical care that used to take place only in hospitals is 
now increasingly being delivered in non-hospital settings. As 
that shift occurs, we are seeing a growing number of outbreaks 
in those settings. These are settings where infection control 
programs and oversight are generally less rigorous compared to 
hospitals.
    Today I will focus my remarks on healthcare associated 
infections that happen because of lapses in basic infection 
control.
    Infection control refers to the established collection of 
rules and procedures designed to prevent the spread of 
infection during healthcare, including basic safe practices 
such as not reusing syringes or appropriately sterilizing or 
disinfecting equipment. Lapses in those basic safe practices 
are entirely unacceptable. These are never events. 
Unfortunately, we continue to see egregious errors that have 
resulted in transmission of serious infections. As a result CDC 
is working in a number of ways to evaluate the problem and 
launch prevention strategies to stop these lapses from 
occurring.
    CDC has worked with State and local health departments 
across the country and identified numerous lapses in basic 
infection control over the past several years. Recent examples 
include using the same syringe for more than one patient, 
accessing a shared vial of medication with a used syringe, 
using contaminated equipment for diabetic testing, inadequately 
cleaning and disinfecting medical equipment, such endoscopes, 
and improperly reusing medical devices like biopsy needle 
guides. Such practices are simply unacceptable, unfortunately 
they are happening across the spectrum of healthcare, 
particularly in non-hospital settings. More must be done to 
ensure that correct infection control practices are maintained 
wherever medical care is delivered.
    CDC is actively engaged in eliminating these events. Our 
current efforts include developing national infection control 
guidelines and working with Centers for Medicare & Medicaid 
Services (CMS) to ensure that they are followed, developing 
checklists for State and CMS surveyors to evaluate facilities 
infection control practices, responding to outbreaks and 
emergent patient safety threats, educating healthcare personnel 
and patients about basic infection control requirements, and 
promoting the development of safer medical devices.
    Our ultimate goal is to ensure that all patients receive 
safe care in every healthcare setting. We use CMS oversight and 
payment policies to drive adherence to CDC's infection control 
guidelines; however, when there is a lapse in infection control 
patients must be protected from harm. Local and state 
authorities are used to halt the unsafe medical practice. It is 
then necessary to identify which individuals were exposed and 
to promptly notify them so that they can receive appropriate 
care.
    Sadly in the past 10 years, over 100,000 patients have had 
to be notified that they were exposed to infection control 
lapse related to the unsafe injections, even more patients have 
been exposed to other areas such as improper sterilization of 
equipment.
    Ensuring appropriate infection control in all healthcare 
settings is a priority for CDC. Our public health system is 
crucial to ensuring safe care for patients, providing a unified 
approach to implementing infection control, monitoring safety, 
investigating and controlling outbreaks, providing oversight 
and education, and researching new ways to improve healthcare 
quality.
    As we work toward elimination of healthcare associated 
infections, ongoing vigilance is needed as new healthcare 
settings and changing technologies create new challenges to 
healthcare safety. CDC continues to address those challenges 
working to ensure that our patients are safe in every 
healthcare setting. We know how to protect patients from these 
infections; they can and must be prevented.
    Thank you for this opportunity to testify. I am happy to 
take any questions you might have.
    [The prepared statement of Dr. Bell appears on p. 67.]
    The Chairman. Thank you very much, Doctor.
    Mr. Watson, you are recognized.

          STATEMENT OF ANTHONY D. WATSON, BS, MS, MBA

    Mr. Watson. Mr. Chairman, Ranking Member Filner, and 
Members of the Committee, thank you for the opportunity to 
discuss reprocessing of reusable medical devices and the 
importance of adequate reprocessing to protect patient safety.
    Today, I will discuss the challenges to ensuring the safety 
of reprocessed medical devices and describe actions FDA is 
taking to address those challenges.
    Reusable medical devices are devices that are designed and 
labeled for use on multiple patients and are made of materials 
that can withstand repeated reprocessing, including manual 
brushing and the use of chemicals. Some examples of reusable 
medical devices are surgical instruments, such as clamps and 
forceps; endoscopes, used to visualize areas inside the body; 
and accessories to endoscopes, such as arthroscopic shavers; 
and laparoscopic surgery accessories, such as graspers and 
scissors.
    All reusable medical devices can be grouped into one of 
three categories according to the degree of risk of infection 
associated with their use. Critical devices, such as surgical 
forceps, semi-critical devices, such as endoscopes, and non-
critical devices, such as stethoscopes.
    Adequate reprocessing of reusable medical devices is a 
critically important step in protecting patient safety. 
Reprocessing is intended to remove blood, tissue, and other 
debris to ensure that devices are safe for the next patient 
use. Reprocessing can be both labor-intensive and time-
consuming, because most reusable medical devices require a 
specific reprocessing regimen.
    In general, reprocessing reusable medical devices involves 
three steps: initial cleaning which is at the point of use; 
transfer to the reprocessing work area where the device is 
thoroughly cleaned; and disinfection or sterilization, 
depending on the intended use of the device, its risk of 
infection transmission, and the materials from which it is made 
as well. The device is then stored or routed back into use.
    Many factors contribute to reprocessing difficulties, 
including device complexity, absence of best practices, user 
error, and poor instructions on how to reprocess.
    Manufacturers, healthcare facilities, healthcare 
professionals, and FDA share responsibility for reducing the 
risk of healthcare-associated infections, or HAIs, from 
inadequately reprocessed reusable medical devices.
    HAIs are infections caused by a wide variety of common and 
unusual bacteria, fungi, and viruses during the course of 
receiving medical care.
    Under FDA labeling regulations, a device must have adequate 
directions for use. This includes instructions on how to clean 
and disinfect or sterilize a reusable device to ensure that it 
is effectively prepared for its clinical use.
    FDA applies its unique position and expertise to reduce the 
risk of infection from reusable medical devices by evaluating 
devices prior to marketing, identifying device designs that 
facilitate proper reprocessing, assuring that manufacturer 
instructions are clear, and promoting collaboration among all 
stakeholders.
    FDA also works with manufacturers to correct product 
problems associated with reprocessed medical devices.
    FDA expects manufacturers to design their devices to 
minimize debris retention, provide complete and easy to 
understand reprocessing instructions, and validate the 
reprocessing protocols using clinically relevant soil.
    Healthcare institutions should periodically assess 
infection control practices in clinical areas, ensure that 
those responsible for reprocessing understand the importance of 
the job, and are given the necessary training to perform it 
properly. Reprocessing staff should understand the distinct and 
separate steps of reprocessing, and they should follow 
reprocessing instructions provided by device manufacturers.
    Physicians and nurses should consider that reprocessing 
plays a role in device performance and follow up with the 
appropriate chain of accountability, such as reporting adverse 
events that may be related to inadequate reprocessing, 
following guidelines established by professional societies, and 
communicating with manufacturers regarding labeling issues and 
ease of reprocessing.
    While FDA believes that the risk of acquiring an HAI from a 
reasonable device is relatively low and that the benefits of 
these important devices outweigh their risks, we are taking a 
collaborative approach toward improving the reprocessing of 
reusable medical devices.
    On April 29th, 2011, FDA launched the Reusable Medical 
Devices Improvement Initiative to reduce the risk of HAIs from 
inadequately reprocessed medical devices.
    FDA's approach to addressing reprocessing problems focuses 
on collaborating with other government agencies, manufacturers, 
healthcare facilities, and healthcare professionals to 
strengthen all steps in reusable device reprocessing by 
fostering improved, innovative device designs to reduce debris 
retention, strengthening the science of cleaning and high-level 
disinfection or sterilization of medical devices, and ensuring 
that healthcare facilities properly perform cleaning, 
disinfecting, and sterilization.
    Specifically, FDA has issued revised draft guidance that 
updates and clarifies the recommended content of and review 
procedures for medical device applications concerning the 
labeling instructions for reprocessing reusable medical 
devices.
    In addition, this draft document provides more detail about 
FDA's recommendations for the validation of processes intended 
to support reprocessing.
    We have also announced a public meeting to be held on June 
8th and 9th to bring together key stakeholders, including 
industry user facilities, standards organizations, healthcare 
accreditation organizations, government agencies, and 
professional societies.
    This is the first in a series of conversations between FDA 
and reusable device stakeholders to discuss factors effecting 
the reprocessing reusable medical and FDA's plans to address 
the identified issues.
    Finally, FDA has developed a Web page that provides general 
outreach about reprocessing of reusable medical devices to 
educate consumer and healthcare professionals.
    Reducing the risk of infection from reusable medical 
devices is critical to protecting patients and is a shared 
responsibility. By using its unique vantage point, FDA is 
helping to address current problems with reprocessed devices 
while facilitating improvements in innovative design in the 
next generation of these devices.
    Mr. Chairman, this concludes my formal statement. I will be 
happy to address any questions you may have.
    [The prepared statement of Mr. Watson appears on p. 71.]
    The Chairman. Thank you very much, Mr. Watson. Is it safe 
for me to assume that VA has been invited to your June 
workshop?
    Mr. Watson. Absolutely.
    The Chairman. Thank you. Do you see a need for research 
into technologies to develop indicators to improve the ability 
to monitor the quality of reprocessing of reusable medical 
equipment?
    Mr. Watson. One of the elements we have introduced in our 
initiative yesterday was a draft guidance. I apologize that was 
actually Friday. That draft guidance contains information or 
method validation and labeling for these devices.
    In that guidance we talk about the science of reprocessing, 
we get into the steps for reprocessing, we talk about different 
methods of validation, and by doing that we hope that users 
will be able to take that information and use it to improve 
their processes.
    So our role as we see it is to help facilitate 
communication to help ensure that the right information is out 
there for the devices, and as well to help the manufacturers 
produce excellent labels so that people can understand what 
they are actually trying to do in the reprocessing area.
    Specifically we have also included information in there 
that includes a human factors evaluation where users actually 
have to use the labeling to determine whether they can 
reprocess the device properly.
    So our role as we see it is to help facilitate that 
communication, that is what the workshop is about on June 8th 
and 9th.
    The Chairman. And I would like to ask one question for both 
of you to answer. Mr. Watson, if you would answer it first.
    What lessons are to be learned from VA's experience with 
large scale adverse event disclosures?
    Mr. Watson. Well, I think what we have observed from the VA 
is not uncommon as some other Members of the Committee have 
mentioned earlier.
    We have learned that we need to improve the labeling of 
these devices to make sure that people can use them properly. 
And again, I will say that by doing so we can help people do a 
better job of actually reprocessing these devices.
    The communication that we would like to have in the June 
8th and 9th workshop will also allow us to get other 
perspectives, by the way that guidance that we put out is a 
draft so we are asking for comments back on that. We are hoping 
that we can get some more communication in that workshop from 
all stakeholders we have, not only the VA, we have other 
healthcare organizations arriving, we have accreditation 
organizations like JCO, for example, the Commission is going to 
be there, and we are also hoping that users and medical device 
manufacturers will be there so that they can have a dialogue on 
the actual ground-level problems that they are seeing. By doing 
so, we can help those manufacturers come up with better device 
designs.
    Some of the device designs that are out there right now 
don't facilitate reprocessing. They might have narrow lumens 
that make it difficult to clear, they might have hinges, they 
might have rough surfaces on the inner lumens that collect 
debris.
    So we are hoping that by having this dialogue we can lay 
the ground work for future device designs to come out that will 
help facilitate those folks in the hospitals to do a better 
job.
    The Chairman. Dr. Bell.
    Dr. Bell. Unfortunately I think one of the most striking 
things related to what we have heard about today is that it is 
not unique to the VA system. It is emblematic of healthcare in 
the United States. We are seeing lapses in basic practices 
across the county and in Canada as well. This is something that 
needs to be tackled systematically.
    I think that the benefits of being able to work through 
something like this include having an opportunity to deliver 
better products to the users. We have been able to take our 
long-standing guidelines, and this is nothing new in terms of 
science, but those guidelines are now packaged in handy tools 
for CMS surveyors to use when they actually look at facilities. 
The same tools are being used by the Joint Commission.
    It is striking to me that a facility that was shut down in 
Nevada a couple years ago was shut down 3 months after it 
passed with flying colors from a local inspection. The problem 
there is that they are inspecting many of the wrong things. 
They are looking at fire extinguishers and hallway widths, all 
of which are fine, but they are not looking at some of the 
critical issues about infection safety and other safe medical 
practices.
    Being able to translate our guidelines into useful tools to 
put into the hands of the surveyors is one way that we are 
making use of these unfortunate examples.
    Being able to build the guidelines into CMS payment 
policies so that at a broader level we are able to enforce 
adoption of these guidelines with fiscal authorities, that is a 
second way that we are seeing some benefit here.
    With regard to the notification issue we were asked for 
input from the VA and we provided that. Related to that we also 
were able to do some consumer outreach and find out what people 
really wanted to hear about and how they wanted to hear it. 
That is something that we have published on now.
    And then lastly we convened an ethics group to understand 
all of the ramifications of notification, including when is the 
notification something that could be harmful and how do you get 
around that harm to ensure transparency?
    The Chairman. Thank you. Mr. Filner.
    Mr. Filner. Thank you for your testimony today. For the 
record, I would like to note that Secretary Petzel and his 
staff are all in the room. Thank you for staying. I was always 
frustrated when the VA folks would testify and then walk out 
and never listen to the other testimony. So thank you for being 
here and listening to the other witnesses.
    I assume you were here for the earlier testimony. My senses 
was, and tell me if I am right or wrong, but the issues that we 
are dealing with here today are not primarily those of either 
the science or the procedures. We have the procedures, and Dr. 
Petzel explained nine levels of oversight to make sure that 
when mistakes occur we get those new policies in place. That is 
not my sense of where the problem is.
    My sense is still in the accountability and the way we 
communicate. We are a public institution, and we have to handle 
things in a different way than in the private sector and how we 
notify not only the patients, but the public at large and the 
stakeholders.
    I don't know what your sense is that because in all these 
cases that we heard, and I have been to most of the hospitals, 
the problem was whether the employees were implementing good 
policies or not or whether they were covering up those 
incidents. Those became the problems. I think the public 
understands that mistakes are going to be made, they just want 
to have honesty about it. What is the risk, what do I do to 
treat it, and let us get on with it. Not that mistakes won't 
get made.
    I don't know what your sense is, if you want to comment on 
that. I am harping on the accountability because I think that 
is where the problem is.
    Dr. Bell. Well, if I may, I will say that what you are 
describing is an important transformation to a culture of 
safety. This is something that is important across the 
healthcare system in this country.
    There was a time when infection prevention was presumed to 
be the job of an infection control nurse and that that 
individual would take care of. In fact it is everybody's job. 
Anybody who has any contact with a patient is responsible to 
ensure that individual's safety. And having that be understood 
throughout a healthcare system is one of the major goals and 
challenges that we face right now.
    When you talk about accountability hand in hand with 
transparency we want a system where any individual can stop a 
process cold and say, no, what I just saw was a mistake, we 
have to stop that. We have seen that work.
    Shortly after the public was notified in the newspaper of 
syringe reuse mistakes there was a Secretary in a clinician's 
office who watched the physician start to reuse a syringe and 
say I just read that that is wrong. We have to stop doing that, 
and by the way we should notify the health department.
    So that kind of culture of accountability and safety is 
something that I think needs to increase throughout our 
healthcare system.
    Mr. Watson. I would like to add to that if I could. So I 
would like to echo Dr. Bell's comments, and I would like to say 
that it is not only an issue of not being able to communicate 
properly or lack of leadership, it is also unfortunately a lack 
of knowledge and understanding of the process and the 
procedures. There is some science, the science is well known, 
but not to everybody.
    I think there is some element of understanding the 
importance of what needs to be done as well. For our part, what 
we have been trying to do is help propagate that message of the 
importance of doing the right thing all the time and ensuring 
that the folks that are going to be responsible for cleaning 
these devices actually have something less complex that they 
can actually clean.
    We heard from Dr. Petzel that they were reducing the number 
of devices in their hospital, that all the people would have to 
learn how to reprocess. That is a very important step. One of 
the things that we talk about is reducing the complexity of the 
reprocessing system.
    I think it is more than just goes to leadership, it 
actually goes to fixing the system, making sure that we can all 
communicate properly and that we all take our responsibility 
for the links that we put in the chain to correct the system, 
and that is what we are trying to do right now. And I believe 
from what I have heard that it is also what VA and CDC have 
done. We have had communication about various topics, not just 
this issue, where we are trying to close the loop on that.
    Mr. Filner. Thank you very much. Thank you, Mr. Chairman.
    The Chairman. Mr. Bilirakis.
    Mr. Bilirakis. I have no questions, they were already 
asked.
    The Chairman. Ms. Buerkle.
    Ms. Buerkle. Thank you, Mr. Chairman. Thank you both for 
being here today. Just a question to Dr. Bell.
    What guidance do you think the CDC could provide for risk 
management?
    Dr. Bell. By risk management do you mean in terms of 
preventing these problems?
    Ms. Buerkle. Yes.
    Dr. Bell. We have actually just produced a consolidated 
document that takes all of the existing guidelines, which 
admittedly are substantial, and condenses them down for the use 
of ambulatory care settings where many of these errors are 
occurring. That is now up on the Web site and is a nice 12-page 
synopsis of the minimum expected standards for safe practices.
    I think we are recognizing increasingly that having a large 
scientific document sitting on a Web site is not good enough 
and that we need to produce easy, simple, straight forward 
things.
    We are also partnering with organizations like the Safe 
Injection Practices Coalition to produce useful graphic 
materials and tri-fold pamphlets and so on, posters, that 
individuals can use at the site of care as reminders for care 
providers.
    So I think there are many ways that we can reduce risk by 
pushing the information. As Mr. Watson said, it is not a lack 
of information, it is that the people doing the practices don't 
always have it.
    Ms. Buerkle. And just if either one of you know the answer 
to this question.
    What percentage of instruments that are used on an ordinary 
basis in a hospital are disposable versus reusable?
    Mr. Watson. I don't have that information. We have try to 
go back and find that out though if you would like.
    [The FDA subsequently provided the following information:]

          According to our database, the Food and Drug Administration 
        (FDA or the Agency) has cleared approximately 232 devices that 
        are intended to be reprocessed since 1980. These are various 
        devices such as endoscopes, (e.g., bronchoscopes, 
        duodenoscopes, and colonoscopes), endoscope accessories, 
        forceps, arthroscopic shavers, etc. However, this number cannot 
        be considered comprehensive because there are limitations to 
        the information. For example, our databases have not always had 
        the ability to track devices intended to be reprocessed. Also, 
        this number could include devices that have been modified and 
        provided to FDA under a new submission. Therefore, this number 
        would include duplicates. Another challenge is that not all 
        devices require a submission to FDA. For example, most of the 
        reusable manual surgical instruments are Class I exempt and are 
        reusable. They do not need a submission to FDA to go to market.
          Regarding disposable devices, the percentage in use in 
        hospitals depends on what one calls ``disposable.'' Some 
        devices are comprised of both reusable and disposable 
        components, making a calculation for the percentage in use 
        rather difficult. For example, scalpel handles are reusable, 
        but their blades are single use, disposable. Large bore biopsy 
        needles may be reusable but most narrow lumen needles are 
        single use, disposable. Endoscopes used during surgery are 
        reusable, but their connecting tubing--to deliver and drain 
        irrigation fluid, is disposable. There are perhaps a hundred, 
        if not more, 510(k) clearances for the reusable rigid 
        sterilization trays and containers which hold the reprocessed 
        manual surgical instruments. Most of the more recent 
        submissions have multiple models of trays in different sizes 
        and shapes, with different internal configurations to hold 
        specialized instruments in some cases.

    Ms. Buerkle. That would be helpful.
    And as a followup to that, of those that are reusable which 
ones pose the most significant problems, and what are the ones? 
Obviously not all of reusable instruments probably have the 
same occurrence as with complication, so if there is any way to 
find out which are the ones most responsible for these problems 
that would be helpful as well.
    Mr. Watson. Well, if I may, we are actually doing that 
research to get that information, because one of the things we 
want to do is be able to help manufacturers understand which of 
their devices are most at risk. But we do know some of the 
device design issues that play into that and I kind of 
mentioned some of those earlier, narrow lumens, devices that 
have rough surfaces on the inside that retain debris. If that 
debris happens to dry out and they don't clean it properly and 
it happens to dry it is very difficult to get out at a later 
date and it might actually still be there further down the 
line, devices that have attachments to them they collect 
debris, and sometimes there are issues chemicals and material 
compatibility also.
    So we are actually studying device designs that we know are 
problematic, and in fact we have partnered with the University 
of Michigan, and they are doing a two-phase study for us. They 
are actually looking at device designs that might cause 
problems, and there will be some interesting information coming 
back on that, and they are also looking at reprocessing 
instructions, that is the next phase at very specific devices 
looking at the reprocessing instructions to see if those 
reprocessing instructions make sense and they can actually be 
followed.
    So we will hopefully have more information on that at a 
later date, but we are looking at that right now.
    Ms. Buerkle. Very good. Thank you very much. I yield back 
my time.
    The Chairman. Thank you very much. Any other further 
questions? If not we thank you. We do have some followup 
questions that will be submitted for the record.
    All Members will have 5 legislative days to revise and 
extend their remarks and submit questions for the record if 
desired.
    Thank you very much for being here, we thank VA for being 
here today, and we have votes coming up in just a moment, so if 
there is no further business this Committee meeting is 
adjourned.
    [Whereupon, at 1:04 p.m., the Committee was adjourned.]



                            A P P E N D I X

                              ----------                              

                Prepared Statement of Hon. Jeff Miller,
                Chairman, Committee on Veterans' Affairs
    The Committee will come to order.
    Good morning and welcome to today's Full Committee hearing ``Sacred 
Obligation: Restoring Veteran Trust and Patient Safety.''
    Before we begin, I would like to ask unanimous consent for our 
colleagues Lacy Clay from Missouri, Jerry Costello from Illinois, 
Blaine Luetkemeyer from Missouri, Ros-Lehtinen from Florida, John 
Shimkus from Illinois, Mike Turner from Ohio, and Frederica Wilson from 
Florida to sit at the dais and participate in today's proceedings.
    Hearing no objection, so ordered. Thank you all for joining us.
    We, as a Nation, put our trust in the men and women who serve in 
our Armed Forces to protect us and our freedoms. And, in return, our 
servicemembers put their trust in us to provide them with the highest 
quality healthcare.
    However, incident after incident of serious patient safety 
violations in VA medical facilities across the Nation in locations such 
as Dayton, St. Louis, and Miami, resulting in thousands of veterans 
across the country receiving notification of their potential risk for 
infectious diseases like HIV and hepatitis, shatters the very trust 
veterans should have in us.
    After each of these incidents, the VA assured Congress, and the 
country, that it was aggressively addressing patient safety issues and 
never again would a veteran's trust be compromised by lapses in quality 
care at a VA medical facility. And yet, each patient safety incident 
has seemingly led the way for the next ``lessons learned'' and the 
unacceptable and inexcusable revelation that the patient safety 
culture in VA is fractured and accountability and leadership at the helm
 are lacking.
    The time for talk is over. VA must confront these issues head on, 
deepen the obligation to care for the veterans affected by these 
incidents, and make the necessary changes within the VA healthcare 
system to prevent any future incidents that would put veteran patients 
at risk.
    To that end, at this hearing today we will address in depth the 
efficacy of VA's patient safety policies and VA leadership's ability to 
provide adequate oversight of its medical facilities.
    Further, we will explore the development of proactive strategies 
for addressing the issues that underlie the lapses we've seen in 
patient safety including the need for: (1) improvements in reprocessing 
of reusable medical equipment; (2) systematic ways for VA to limit the 
activities of suspect practitioners; and (3) better and more consistent 
risk management and notification processes for veteran patients when 
incidents do occur.
    It is unconscionable that any one of our veterans should ever be 
exposed to infectious diseases because of the care they receive at a VA 
medical facility.
    I want to assure all of you that this Committee will be tireless in 
its oversight to ensure that VA lives up to its creed to provide only 
the very best and the very safest care anywhere.
    I thank you all for joining us for this important and ongoing 
discussion.
    Before I yield to the Ranking Member, I'd like to remind witnesses 
that testimony is due no later than 48 hours in advance of a Committee 
or Subcommittee hearing. I am told the DAMA Subcommittee did not 
receive VA testimony until late yesterday in preparation for today's 
8:00 a.m. hearing. That is inexcusable.
    In addition, I and other Committee Members submitted a series of 
questions 7 weeks ago in relation to VA's FY 2012 budget request, yet 
no responses have been received. I would ask those here from VA today 
to please convey my disappointment about this performance and my 
expectation that things will improve in the very near future. I yield 
to the Ranking Member.

                                 
                 Prepared Statement of Hon. Bob Filner,
     Ranking Democratic Member, Full Committee on Veterans' Affairs
    Good morning. I would like to thank everyone for attending this 
important hearing today.
    The purpose of today's hearing is to gauge VA's response to several 
recent incidents that profoundly affect veterans due to the failure of 
some to follow policies, procedures and protocols that have been put in 
place to prevent such occurrences.
    We are also going to look at what measures have actually been 
implemented to ensure that these types of lapses do not happen again.
    Mr. Chairman, I have to say, and I think you would certainly agree 
that we have been here before! Please indulge me in my brief chronology 
of events.
    In December 2008, we were notified of improper reprocessing of 
endoscopes which put thousands of veterans in Murfreesboro, Mountain 
Home Tennessee, and Miami, Florida, at possible risk of hepatitis and 
HIV.
    In February 2009, another 1,000 veterans in Augusta, Georgia, 
received notifications that they were at risk for hepatitis and HIV 
because of improper processing of ear, nose, and throat endoscopes.
    In July 2010, this Committee held a field hearing in St. Louis, 
Missouri, a hearing you attended Mr. Chairman, along with many of our 
colleagues today, after we had learned of lapses in protocol with the 
cleaning of dental equipment which put at risk 1,800 veterans.
    The most recent notification, the egregious incidents at Dayton, 
Ohio, affected over 500 veterans and involved a whole host of problems. 
The findings beg the questions of proper accountability, effective 
oversight and enforcement of clear policies and procedures.
    Policies and procedures that are sometimes not followed--or worse--
get completely ignored. I would like to know, where is the strong, 
proper leadership and effective communication that is critical when you 
are entrusted with the care and well being of our Nation's veterans.
    Let me point to another big concern as a result of these incidents 
and that is the absolute need for effective communication within the 
management ranks and below. I am sure the Secretary of Veterans' 
Affairs would agree with me on this.
    Clearly, VA has had issues with ensuring the sterility of reusable 
medical equipment in the past and now, other patient safety issues have 
come to light, as evidenced in the continuing problem of veterans being 
vulnerable to infectious diseases due to the problematic, yet 
prevalent, issue of lack of following sound agency guidelines and 
policies concerning patient safety.
    In addition to what has been looked at over the past 3 years, I am 
strongly dedicated to the need for ensuring that we do everything 
possible so that this does not happen again.
    And, as we are all aware, VA has a higher commitment and a moral 
compact to provide the utmost level of care possible. It is this 
Committee's responsibility to ensure that VA has the proper resources 
to fulfill that mission.
    I would like to acknowledge and want to recognize the VA's 
excellent healthcare services and the dedication of the vast majority 
of their staff.
    I would also like to acknowledge the work they have done to 
mitigate the issues at hand. We know it has not been easy.
    I look forward to hearing today's testimony.

                                 
                 Prepared Statement of Hon. John Barrow
    Thank you Chairman Miller and Ranking Member Filner for holding 
this hearing on restoring the trust our veterans have in VA's services. 
We can't keep those promises if veterans don't trust that VA's 
facilities and services are safe.
    This is an issue that hits close to home for the veterans in my 
district. The Charlie Norwood VA Medical Center in Augusta, GA has been 
found out of compliance of VA's sterilization process in 2008, 2009, 
and 2010. They have had to warn veterans that they may have been 
infected with diseases because of unclean ear, nose, and throat 
utensils. As recently as November, the Charlie Norwood VA Medical 
Center had to halt all elective procedures because they were not 
following the proper sterilization procedure.
    Just 2 weeks ago, The American Legion inspected the Charlie Norwood 
VA Medical Center in Augusta, GA. The Legion found what we already 
know: like many VA facilities throughout the Nation, the Charlie 
Norwood VA Medical Center has been under the supervision of an ``Acting 
Director'' for several months. Without a permanent director a VA 
hospital does not have the long term leadership to initiate the reforms 
to ensure high quality, safe, and reliable care. And until veterans can 
trust that the care they receive is high quality, safe, and reliable we 
aren't keeping the most basic promise to them.
    I look forward to the testimony of today's witnesses, and I hope we 
can identify specific solutions to specific problems, like having too 
many ``Acting Supervisors'' in positions that require long term 
accountability.

                                 
                Prepared Statement of Michael R. Turner,
          a Representative in Congress from the State of Ohio
    Chairman Miller, Ranking Member Filner, I would like to thank you 
for your leadership on this issue. Your responsiveness to my request to 
visit the facility in Dayton and decisiveness in holding this vitally 
important hearing are a testament to your dedication to our Nation's 
veterans.
    Along with the many other tragic issues addressed in today's 
hearing, the events that transpired at the Dayton VA Dental Clinic are 
extremely disconcerting because they further illustrate systemic 
problems in the medical system that provides care for our Nation's 
veterans. The dentist in question violated infection control standards 
for nearly two decades. During a significant period of this time he did 
so with the knowledge of many fellow employees and some supervisors. In 
failing to report these problems the clinic needlessly put thousands of 
veteran lives at risk. Several patients have tested positive with 
hepatitis, and I, along with a panel of healthcare professionals, 
believe that many more are at risk and should be notified and tested.
    Last week, I participated in a field hearing with Senator Brown 
under the jurisdiction of the Senate Veterans Affairs Committee on this 
same issue. As I discussed there, it is important for the community to 
become involved in this process because they were the victims and their 
input will be vital in reestablishing the community's trust. In an 
effort to ensure the safety of all the identified victims and 
potentially unidentified victims, the Greater Dayton Area Hospital 
Association (GDAHA) has reached out to the VA to help in this process. 
GDAHA is empaneled by a group of local physicians and has the community 
interests in mind.
    During the course of their investigation GDAHA recently published 
an interim report in which they disagreed with the VA's decision to 
limit the look-back period to 1992. Instead the group concluded that 
the VA should notify and test all patients seen by the DIQ, to include 
the next-of-kin of deceased patients. Their independent conclusions 
were made with a view towards the best interest of the patients and 
community and were free from the influence of VA leadership. I have 
submitted this information to Secretary Shinseki and requested that he 
adhere to their recommendations. I hope that he will choose to enact 
these recommendations in order to protect those that may have been 
exposed and help restore the community's faith in the VA.
    While I appreciate the investigations that have been conducted by 
the VA, I would like to point out that internal constraints placed on 
the OIG investigative team bring the findings of their investigation 
into question. I am concerned that the scope of the OIG investigation 
was limited by an inability to interview key witnesses. As the report 
itself states, the OIG investigative body was unable to interview 
several key witnesses simply due to their retirement. These witnesses 
included the original SOARS complainants, a fellow dentist and the 
facility's Chief of Staff. Their exclusion from the evidence gathering 
process devalues the OIG's findings significantly and raises a very 
serious question.
    Simply stated: What kind of system does the VA have in place where 
the leadership can evade investigative processes simply by opting into 
retirement? The ultimate consequence of this model is that veterans and 
their families carry the scars and the taxpayers carry the debt while 
the responsible individuals walk away into comfortable retirement 
without accounting for their negligence.
    This system is broke and it needs to be fixed. The VA and Congress 
share a responsibility to provide the greatest amount of protection for 
all the potentially affected veterans and their families. In light of 
this, I concur with GDAHA's recommendations that the VA should notify 
and test all patients seen by the DIQ, to include the next-of-kin of 
deceased patients. I also take issue with the underlying rationale to 
limit the scope of the testing.
    In moving forward, I hope that the VA will make a greater effort to 
work with Congress and the community to ensure that all potentially 
affected victims are notified and tested. Further, I would like the VA 
to work in concert with regional stakeholders to identify the 
underlying problems that allowed this tragedy to happen, and devise a 
solution that will prevent it from ever happening again. In order to 
accomplish this, the VA should conduct an open and transparent process 
that includes information sharing with GDAHA and the community.
    After all, our country has thousands of young men and women that 
are making as great of a sacrifice as any generation before them. We 
need to make sure that they have the peace of mind to know that if they 
need help when they are done, there will be a fully functioning and 
competent VA here to give them that help when they need it. Further, we 
need to ensure that a system is in place that holds the leadership 
accountable for their actions and does not allow them to simply walk 
away at the first sign of trouble. This leadership from the rear 
mentality has no place in the Department of Veterans Affairs and is 
particularly shameful in an environment built to care for those 
veterans that kept our country safe and free.

                                 
             Prepared Statement of Hon. Jerry F. Costello,
        a Representative in Congress from the State of Illinois
    I would like to thank Chairman Miller for holding today's hearing 
to examine repeated lapses in patient safety at U.S. Department of 
Veterans Affairs (VA) facilities. I look forward to hearing about the 
underlying issues causing these failures and what changes were 
implemented to ensure they do not happen again.
    As I have said on numerous occasions, the dedicated efforts of VA 
employees and their strong commitment to quality care are an example of 
our country's sincere promise to look after the brave men and women who 
have protected our Nation for over two centuries. Their compassion and 
expertise are an asset to the VA and I encourage the employees to 
remain diligent about communicating discrepancies in protocols.
    Many of my constituents receive medical care from John Cochran 
Veterans Medical Center (VAMC) in St. Louis, Missouri, which was the 
subject of a July 2010 field hearing to examine lapses in cleaning 
reusable dental equipment. This occurrence was disturbing by itself--
putting the health of 1,812 veterans at risk--but to know that it is 
one of many instances in which the VA has failed to perform the basic 
duties of its daily operations is truly shocking. For example, a March 
7, 2011, VA Office of Inspector General (VA OIG) report on a site visit 
to John Cochran VAMC noted numerous inconsistencies remained after the 
July hearing, ranging from the unavailability of manufacturer's 
instructions on how to clean reusable medical equipment (RME), 
insufficient staff training, and inadequate oversight.
    Several other reports and investigations by the VA OIG and the 
General Accountability Office (GAO) have also identified continued 
breakdowns in management practices for VA and facility leadership. 
Despite the fact that both the VA OIG and GAO indicate that policies 
and directives are in place, we are holding another hearing regarding 
repeated oversight and compliance failures that put patient safety in 
jeopardy.
    These occurrences must stop and I implore the VA to work with 
Congress to implement the proper training and oversight necessary to 
limit these occurrences in the future, as we have been promised several 
times would happen by VA officials.
    Patient safety remains our top priority and our veterans deserve 
the very best care available. Congress has a sacred obligation to 
ensure the VA has the resources necessary to fulfill this promise.
    I look forward to today's testimony.

                                 
           Prepared Statement of Hon. Robert A. Petzel, M.D.,
      Under Secretary for Health, Veterans Health Administration,
                  U.S. Department of Veterans Affairs
    Chairman Miller, Ranking Member Filner, and other Members of the 
Committee. Thank you for the opportunity to discuss the Department of 
Veterans Affairs' (VA) patient safety policies and strategies that 
build trust and ensure the safe and compassionate care of our veterans. 
I am accompanied today by Robert Jesse, M.D., Ph.D., Principal Deputy 
Under Secretary for Health; William Schoenhard, Deputy Under Secretary 
for Health Operations and Management, George Arana, M.D., Acting 
Assistant Deputy Under Secretary for Health for Clinical Operations, 
and Andrea Buck, M.D., Acting Chief Medical Officer.
    First and foremost, I would like to apologize on behalf of the 
Department to those veterans who have been affected by a lapse in 
patient safety practices at any of our facilities. The greatest 
commitment of every VA employee is the well-being of our veterans. In 
the Veterans Health Administration (VHA), from the housekeeper, who 
ensures each patient's room is clean, to the Under Secretary for 
Health, we are united in a common mission to protect and provide 
quality healthcare for those who served to defend this Nation.
    When a lapse in patient safety practices occurs, it is VA's 
fundamental belief that we must be open and transparent with regard to 
our mistakes and any necessary actions that may result. This can result 
in disclosing medical events even when not a common practice by others 
in the medical community. For example, in 2010, The New England Journal 
of Medicine published an article noting that large-scale adverse events 
in medical settings are not uncommon; the article described in detail 
VA's disclosure policies and concluded, ``The VHA policy represents a 
valuable resource for all healthcare institutions.'' \1\ We carefully 
consider the effects of any disclosure, but our practice is to provide 
more information to our veterans in an abundance of caution, even if 
the risk to their health is low.
---------------------------------------------------------------------------
    \1\ Denise M. Dudzinski, Philip C. Hebert, Mary Beth Foglia, and 
Thomas H. Gallagher. ``The Disclosure Dilemma, Large Scale Adverse 
Events.'' The New England Journal of Medicine. Vol. 363, no. 10. 
September 2, 2010. P. 978-986, p. 984.
---------------------------------------------------------------------------
    We are particularly concerned about any event where veterans are 
put at risk because we believe we provide excellent care, and we have 
the data to support that belief. Despite caring for patients that are, 
on average, sicker, older, and less affluent than the general 
population, VA's performance overall exceeds the best U.S healthcare 
systems. Our data collection and publication program is unprecedented 
in U.S. healthcare, as we report more data about our programs online 
than anyone else. As the Wall Street Journal observed in March 2011, 
``This usually comprehensive sort of consumer information on medical 
outcomes remains largely hidden from the tens of millions of Americans 
outside the VA system.'' \2\ Professional publications and the 
mainstream media have recognized and lauded our accomplishments in 
providing the best integrated healthcare in the country. Recently, The 
New England Journal of Medicine published an article praising our 
programs to reduce healthcare-associated infections by methicillin-
resistant Staphylococcus aureus (MRSA), a bacteria known to be 
resistant to most antibiotics.\3\ In the words of a New York Times 
editorial about this study, ``If other hospitals could replicate the 
effort, thousands of patients might be saved from needless infections 
acquired after they entered the hospital.'' \4\
---------------------------------------------------------------------------
    \2\ Thomas M. Burton. ``Data Spur Changes in VA Care.'' The Wall 
Street Journal. March 29, 2011. Available online: http://
online.wsj.com/article/SB10001424052748703512404576208812390 
820304.html.
    \3\ Rajiv Jain, et al. ``Veterans Affairs Initiative to Prevent 
Methicillin-Resistant Staphylococcus aureus Infections.'' The New 
England Journal of Medicine. Vol. 364, no. 15. April 14, 2011. P. 1419-
1430.
    \4\ The New York Times. ``Hospitals Shouldn't Make You Sicker.'' 
April 17, 2011. Available online: http://www.nytimes.com/2011/04/18/
opinion/18mon3.html.
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    These accomplishments are significant, but they are not, and never 
will be, enough. We owe it to our veterans and ourselves to continually 
strive to be better. We must be the veteran-centric, results-driven and 
forward-looking organization the Secretary has called us to be. This 
means we will continually learn how to do our jobs more effectively, 
more efficiently, and more compassionately.
    My testimony today will provide an overview of our quality and 
patient safety programs. It will then describe our practices for 
standardized reprocessing of reusable medical equipment; our systematic 
approach to limiting the activities of suspect practitioners through 
rigorous credentialing and privileging, as well as peer review; and 
risk management and notification processes for veterans.
VA Quality and Safety Programs
    VA is committed to providing the safest and highest quality 
healthcare for veterans. We have established a wide array of innovative 
and comprehensive programs to measure, analyze, improve and report on 
all aspects of healthcare quality and patient safety. We have published 
an annual report on each facility's quality and safety performance 
since 2008, and these reports are available online (http://www1.va.gov/
health/HospitalReportCard.asp). The 2010 report includes new metrics, 
such as medical and surgical outcomes data, as well as a detailed 
analysis of VA's safety reports. We have identified six domains in line 
with the Institute of Medicine's recommendations for quality in 
healthcare: effective, equitable, safe, timely, patient-centered, and 
efficient. We have been an early adopter of performance measurement and 
improvement because we at VA have a special responsibility to maintain 
the trust of the veterans we serve and the public at large.
    All eligible VA facilities and programs have been accredited by The 
Joint Commission, and over 200 programs were accredited by the 
Commission on Accreditation of Rehabilitation Facilities. The Joint 
Commission's accreditation is nationally recognized as a symbol of 
quality and is considered one of VA's major external quality reviews. 
Joint Commission accreditation confers recognition that VA healthcare 
organizations meet certain standards of quality and safety, as well as 
compliance with healthcare quality standards of payors. The Commission 
on Accreditation of Rehabilitation Facilities reviews VA programs 
designed to provide specialized treatment and quality rehabilitation to 
veterans with disabilities. Various specialty programs are also often 
reviewed and accredited by boards with expertise in those disciplines. 
We estimate that more than 4,100 site visits occur at VA healthcare 
facilities each year to support approximately 2,000 total accreditation 
reviews and inspections.
    According to the Healthcare Effectiveness Data and Information Set 
(HEDIS), VA facilities provided high quality outpatient medical care 
and compared favorably with the top performing health plans in the 
Nation. When looking at disease-specific healthcare within inpatient 
settings, VA also compares favorably with the best hospitals in the 
Nation on core indicators of quality that are published on Medicare's 
Hospital Compare Quality of Care Web site. The rates of hospital-
acquired infections at VA were generally low when compared with 
national averages according to the Centers for Disease Control and 
Prevention. Many VA facilities report rates that match or are lower 
than the top 10 percent of reporting hospitals in the country (lower 
infection rates are better). High quality outpatient care was available 
to veterans regardless of where they lived. Women veterans receive 
gender-specific care that substantially exceeds care available in non-
VA healthcare systems.
    There are several programs that have proven instrumental to VA's 
success in overseeing quality care. First, VA's Surgical Quality 
Improvement Program (VASQIP) monitors surgical procedures and tracks 
risk-adjusted surgical outcomes, including complications (morbidity) 
and mortality rates. VASQIP analyzes aggregate patient data from 
surgical outcomes of 124 VA facility surgical programs using 
mathematical models to predict an individual patient's expected outcome 
based on the patient's pre-operative characteristics and the complexity 
of the surgical procedure being performed. This calculated expected 
outcome is then compared to an observed outcome on a regular basis. 
Facilities with an observed adverse outcome that significantly exceeds 
expected outcomes undergo a quality improvement assessment to identify 
specific issues that require resolution to enhance patient safety. This 
kind of monitoring has resulted in reductions in patient morbidity and 
mortality across the organization. VASQIP was developed more than 15 
years ago, and the American College of Surgeons now offers a similar 
program to private sector hospitals.
    Another effort is VA's National Center for Patient Safety (NCPS), 
which was established more than 10 years ago to improve the quality and 
safety of care we provide. One key process that NCPS uses when an 
adverse event or a ``close call'' happens is a root cause analysis 
(RCA) to identify the basic or contributing causal factors. This is an 
interdisciplinary review process that focuses primarily on systems and 
processes, rather than individuals, to determine what actually or 
almost went wrong. These investigations can identify changes that 
should be made to either redesign or develop our practices and reduce 
the risk of a similar event in the future. Approximately 40 percent of 
RCAs are done on events that produced little or no harm to patients. 
This is a testament to VA's developed culture of safety, as it reflects 
the willingness of staff to identify close calls for review and 
analysis. The five most common subjects for an RCA include falls; 
delays in treatment, diagnosis, or inpatient surgery; ``high alert'' 
adverse drug events; unexpected deaths (other than suicide); and 
outpatient suicides. Both The Joint Commission and VA require an RCA to 
be completed within 45 days; as such, we track the timeliness of these 
investigations, and we have shown continued improvement over the last 
several years in completing these in a timely manner.
    Finally, VA has recently begun publishing detailed quality and 
safety data online to inform veterans and the public of the care we 
provide. These efforts also improve our internal accountability 
structure. ASPIRE is a Web-based dashboard that documents quality and 
safety goals for all VA hospitals and reports on how individual 
hospitals are meeting these standards. The standards identified by 
ASPIRE are the gold standard and should be the target of every 
healthcare organization; for example, we have targeted zero MRSA 
infections in all of our facilities. We will not necessarily meet these 
objectives, but they should always be our goal. The Linking Knowledge 
and Systems (LinKS) dataset is another dashboard that summarizes 
outcomes in areas such as acute care, safety, intensive care, and other 
measures. LinKS reports quarterly risk adjusted as well as unadjusted 
data that shows how well each VA hospital is performing and areas in 
which each facility can improve. Much of the data in the LINKS and 
ASPIRE dashboards are simply not available in other healthcare systems, 
which limits VA's ability to compare itself against other healthcare 
systems.
    Nevertheless, VA has been identified as a leader in the field, and 
we are setting the bar for other systems to meet. Perhaps most 
importantly, we are using these quality and safety datasets to inform 
the performance reviews of senior leadership. A key element of the 
performance plan for every Veterans Integrated Service Network (VISN) 
Director and VA Medical Center (VAMC) Director is based on objective 
performance in healthcare quality and safety, as measured by 
independent sources of information pulled from our electronic health 
record system. VA has also contracted for an external peer review 
program, which selects a statistically significant random sample of 
cases for each facility and assesses the care we provided. This assists 
VA with validating our internal peer review process and helps ensure we 
are providing the highest quality of care to our veterans.
Standardized Reprocessing of Reusable Medical Equipment
    VA has made significant progress in standardizing sterile 
processing techniques across the Department. We have worked with the 
International Association of Healthcare Central Service Material 
Management, an internationally recognized organization in sterile 
processing, to provide supply, processing and distribution training. We 
have also obtained a national contract to ensure all facilities are 
supplied with up-to-date manufacturers' instructions for sterile 
processing. New standard operating procedures for reprocessing are 
currently in place. Beyond standardizing processes, VA seeks to set the 
standard for effective and safe sterile processing techniques 
nationwide. We have been soliciting proposals from the private sector 
to automate sterile processing techniques to reduce the opportunities 
for human error, and VA is internally pursuing innovations to improve 
the safety, efficiency, and effectiveness of sterile processing.
    Between January 1 and September 30, 2010, VA's Office of Inspector 
General (OIG) Combined Assessment Program reviewed 45 VA facilities to 
evaluate reusable medical equipment practices (RME) to determine if 
facilities complied with VA standards for RME sterilization and high 
level disinfection, provided documentation for annual training, and 
assessed and documented annual competencies for employees who perform 
RME reprocessing activities. OIG identified six areas where compliance 
with RME requirements needs to improve. We appreciate their assessment 
and their recommendations. We have concurred with their 
recommendations, and we have either already completed these 
improvements or we will do so within the next 6 months. Specifically, 
the OIG recommended that VA senior managers (at the national, network, 
and local levels) ensure that:

      Standard operating procedures (SOPs) are current, 
consistent with manufacturers' instructions, and located within the 
reprocessing areas;
      Employees consistently follow SOPs, supervisors monitor 
compliance, and annual training and competency assessments are 
completed and documented;
      Flash sterilization is used only in emergent situations, 
supervisors monitor compliance, and managers assess and document annual 
competencies for employees who perform flash sterilization;
      Appropriate personal protective equipment is donned 
before entering and is worn in decontamination areas;
      Ventilation systems are inspected and filters are changed 
quarterly in all reprocessing areas and that temperature and humidity 
are monitored and maintained within acceptable ranges in sterile 
storage areas; and
      Processes for consistent internal oversight of RME 
activities are established to ensure senior management involvement.

    In response to these recommendations, VA has modified inspection 
processes at the network and facility level to ensure that employees 
consistently follow SOPs and that training and competency assessments 
are complete and documented. Staff from VA's Sterile Processing 
Departments (SPDs) will perform site visits to provide additional 
oversight to ensure that annual training and competency assessments are 
complete as well. We developed and deployed a standardized template as 
of February 14, 2011, that requires facilities to conduct six 
inspections of SPD per year, and for VISN staff to conduct three 
unannounced inspections each year. We will track and review the results 
of these inspections nationally to refine our oversight methods. VA has 
developed a national action plan to specifically address RME concerns 
throughout its entire healthcare system. When VA Central Office learns 
of an adverse event, we immediately activate a fact finding team of 
appropriate subject matter experts to assess the event for veteran 
risk. Depending on this team's determinations, VA may convene a 
Clinical Review Board (CRB) to determine if disclosure to patients 
should occur. We have also realigned our organization to create a 
national SPD office that will provide guidance and oversight for our 
experts in the field.
    We believe veterans should be encouraged by the results of the 
OIG's inspection. While the report identifies areas for improvement, it 
also commends VA facilities for recognizing the importance of 
maintaining consistent RME practices to ensure patient safety. VA's 
policy is to cooperate with all reviews and investigations, from the 
OIG and others, that have been designed to improve service and develop 
better practices for healthcare. Our facilities have been increasingly 
vigilant in monitoring, self-identifying, and investigating any 
inconsistencies in procedures for cleaning RME, and our facilities are 
conducting frequent and repeated reviews of their patient care areas to 
ensure that procedures are clear and followed.
    The Government Accountability Office (GAO) has also reviewed 
selected VA facilities to assess the purchasing, tracking, and 
reprocessing requirements for RME. GAO specifically looked at relevant 
VA policies, as well as two purchasing, two tracking, and two 
reprocessing requirements. These requirements were instituted following 
patient safety incidents at the Palo Alto VAMC, the Miami VAMC, and the 
Augusta and Murfreesboro VAMCs, respectively. GAO did not identify any 
inadequacies in the purchasing requirements they selected for review in 
the context of patient safety. In the area of tracking requirements, 
GAO found VA has a limited ability to identify equipment on which there 
are alerts or recalls and maintaining inventory, and that it also 
experiences challenges developing required training in this area. For 
reprocessing requirements, GAO found VA did not adequately specify the 
types of RME that require device-specific training and that there is 
conflicting guidance on the development of RME reprocessing training.
    We greatly appreciate the work of the GAO in helping VA ensure our 
programs are providing the quality of care our veterans deserve. We 
have already begun instituting changes to address these concerns and 
are ahead of the timeline we outlined for GAO. We are analyzing 
information on non-compliance by specific VA medical centers and are 
overseeing the development of corrective action plans. We are also 
developing a systematic approach to analyzing information to identify 
areas of non-compliance across the Nation, with particular focus on 
those that occur frequently, pose high risks to veterans' safety, or 
that have gone unaddressed. VA has drafted a new handbook that will 
replace all existing sterile processing policies; this handbook will be 
reviewed by experts from the field before publication to ensure its 
requirements are consistent with best practices and capable of 
implementation. To reduce the variation in equipment and accompanying 
processes, VA has established national product specifications and 
criteria for selecting standardized endoscopic equipment. Similarly, an 
Integrated Product Team for Endoscopes has been charged with developing 
recommendations for gastrointestinal (GI) endoscopic equipment. As part 
of our ongoing effort to standardize the reprocessing of RME, we have 
secured a national contract that supplies up-to-date manufacturers' 
instructions to all VA facilities. These efforts will enhance patient 
safety and quality, realize economic value, and reduce variability for 
set up and reprocessing this equipment.
    In addition, VA is partnering with local communities to provide 
state-of-the-art training to those responsible for providing oversight 
of VA's SPD. For example, in Phoenix, Arizona, VA has entered into a 
first-of-its-kind agreement with a local technical college to provide 
VISN SPD boards with a laboratory environment for hands-on training in 
the reprocessing of RME. The first of these courses will begin in June. 
By training the trainers and those responsible for oversight within the 
Department, as well as providing support to community training efforts, 
VA is setting the standard for excellence in the reprocessing of RME 
nationwide.
Credentialing, Privileging, and Peer Review
    Credentialing, privileging, and peer review are essential 
components of our quality and safety program as they assess who is 
competent to perform what types of procedures and how well they 
perform. Credentialing refers to the systematic process of screening 
and evaluating qualifications and other credentials, including 
licensure, required education, relevant training and experience, 
current competence and health status. Clinical privileging is a process 
by which a practitioner, licensed for independent practice, is 
permitted by law and the facility to practice independently, to provide 
specified medical or other patient care services within the scope of 
the individual's license, based on the individual's clinical competence 
as determined by peer references, professional experience, health 
status, education, training, and licensure. Privileging is both 
facility- and provider-specific.
    All VA healthcare providers who are permitted by law and the 
facility to provide patient care independently must be credentialed and 
privileged to do so. VetPro is VA's electronic credentialing system and 
must be used for credentialing of all providers who are granted 
clinical privileges or are credentialed for other reasons. This system 
helps reduce the chance for human error and improves the care we 
deliver at VA. All candidates must submit an application to VetPro 
providing information regarding malpractice, adverse actions against 
licensure, privileges, hospital membership, research, and other 
factors. We do not allow an offer of employment to be made to providers 
until the credentialing process is complete. This process entails 
screening the candidate through the appropriate State Licensing Board, 
the Federation of State Medical Boards, and the National Practitioner 
Data Base (NPDB). The NPDB is a secondary flagging system intended to 
support a comprehensive review of healthcare practitioners' 
professional credentials by identifying any malpractice payments or 
adverse actions against clinical privileges. NPDB screening is required 
before an applicant's appointment; VA then monitors appointed 
practitioners through the NPDB's continuous query program for as long 
as they maintain an appointment at a VA medical facility. The 
information we receive from NPDB offers further insight into the 
provider's history as a clinician and is considered with other relevant 
data in evaluating a practitioner's credentials. VA oversees this 
program at the national, network and facility level to ensure 
compliance.
    Applicants for VA positions are required to respond to questions 
concerning clinical privileges at VA and non-VA facilities. Privileges 
are valid for a period not to exceed 2 years. To approve privileges for 
a provider, VA requires evidence of current licensure, relevant 
training and experience, current competence, and information associated 
with the person's health status as it relates to the individual's 
ability to perform the requested clinical privileges. We also require 
information related to malpractice allegations or judgments, loss of 
medical staff membership, loss or reduction of clinical privileges, or 
challenges to licensure. At the facility level, each service chief is 
responsible for developing additional criteria consistent with the 
needs of the patient population at the facility. We continue to monitor 
privileges based upon quality and performance data on an ongoing basis, 
and we provide numerous training opportunities to ensure that those 
responsible for assessing and validating credentialing and privileging 
standards have the resources they need to help ensure quality patient 
care.
    VA also maintains a robust peer review program to oversee quality 
and accountability for care. Peer review is a process carried out by an 
individual healthcare professional or a select committee of 
professionals to evaluate the performance of other providers. When 
conducted systematically and credibly, as is VA's process, peer review 
can result in both immediate and long-term improvements in patient care 
by revealing areas for improvement in the practice of one or more 
providers, which contributes to organizational improvement and better 
patient outcomes. Peer review is intended to be a comprehensive, 
confidential and non-punitive process that contributes to overall 
quality improvement efforts and to the improvement of care for 
veterans.
    Peer reviews are conducted by internal and external parties. For 
internal reviews, it is VA policy that each VISN and healthcare 
facility must establish and maintain a program of peer review for 
quality management purposes relevant to the care provided. Our 
facilities must comply with the requirements of all applicable 
accrediting and oversight agencies that review VA healthcare 
facilities, including The Joint Commission. We have established 
criteria that indicate who can serve as a peer reviewer to ensure these 
individuals provide competent and accurate information to other 
providers. VHA Directive 2010-025 provides clear guidelines for which 
clinical events require a peer review for quality management purposes. 
As mentioned earlier, VA maintains an external peer review program to 
gather and validate information related to outcomes and processes for 
each of our medical facilities. This provides an important, independent 
assessment of the care we offer and provides an additional source of 
validation for our internal processes.
Risk Management and Notification Processes
    VA has an ethical and legal obligation to disclose to patients 
adverse events they experienced during the course of their care, 
including when the adverse event may not be obvious or severe, or where 
the harm may only manifest in the future. Disclosure of these events is 
consistent with our core values of trust, respect, excellence, 
commitment and compassion. Facility Directors are responsible for 
ensuring that healthcare providers communicate these events to patients 
or the patients' representative and to support staff members who are 
involved. It is VA policy to notify our patients of their rights under 
section 1151 of title 38 United States Code and the Federal Tort Claims 
Act, including information about procedures available to request 
compensation as well as where and how to obtain assistance in filing 
claims.
    One of my chief priorities is to ensure VA is a learning 
organization, and I have emphasized the importance of this philosophy 
to all of our healthcare employees. If an error or an adverse event 
occurs, we must determine if this was the result of a lack of training, 
or some deeper problem. I believe in holding our providers accountable, 
but accountability can take many forms and needs to be evaluated on a 
case-by-case basis. Sometimes disciplinary action is warranted, and in 
a number of situations, we have taken these necessary steps by 
convening Administrative Investigation Boards (AIB) to determine the 
proper response which can and has included administrative action. 
Recommendations from all AIBs are shared and discussed with VHA 
leadership for awareness and as a learning opportunity to understand 
how to deal with any potential future adverse event within their 
facilities.
    In terms of notifications, any events that may require large scale 
patient disclosures must be documented and communicated to VA Central 
Office. When we learn of a potential adverse event, we convene a fact 
finding team of subject matter experts from a range of disciplines to 
assess the situation. At the conclusion of the fact finding review, a 
Clinical Review Board (CRB) may be convened. The CRB is made up of 
appropriate representatives from a range of disciplines and include 
experts on quality and safety, public health, ethics, operations and 
management, patient care, and VHA leadership. The CRB considers factors 
such as the population at risk, the potential severity of outcomes, the 
probability of those outcomes, and other factors relevant to the 
population at risk. VHA Directive 2008-002 provides specific guidance 
regarding what adverse events warrant disclosure, when disclosure 
should occur, and how adverse events should be communicated.
    We are also keenly aware of the need to disclose in a manner that 
does not exacerbate problems and unduly worry our veterans or their 
families. We have convened a working group that is developing common 
guidance and templates for disclosures, and we expect to have results 
from this group this summer.
Conclusion
    Our primary mission at VA is to serve our Nation's veterans. In 
terms of healthcare, this means providing veteran-centered care that 
focuses on improving the lives and well-being of our patients. VA is 
more transparent and makes available to the public more information 
about our entire system than any other healthcare provider in the 
country. Our initiative in this area earned the Department the Annual 
Leadership Award from the American College of Medical Quality. We 
subject our facilities to greater scrutiny through both external 
commissions and accreditation organizations as well as internal reviews 
from the facility, network and national level, including from the 
Office of the Inspector General and GAO. We welcome these assessments 
because they provide us with learning opportunities that will produce 
even better healthcare systems and outcomes. And we welcome 
Congressional oversight, as we work together to serve our veterans.
    At VA, our fundamental belief is that our healthcare system is 
designed to serve veterans, and that to do so, veterans must be an 
equal partner in their healthcare decisions. For this partnership to 
work, we must make sure they have access to the data they need to make 
an informed decision, and that they must trust us to provide them this 
information. We understand that disclosures can raise concerns among 
the public, but we believe that veterans will have greater confidence 
in a system that errs on the side of providing more information to 
them, even when their health risk is low.
    Thank you for inviting me here to testify today to discuss our 
efforts in these vital areas. My colleagues and I look forward to any 
questions you may have, and we welcome this discussion.

                                 
            Prepared Statement of John D. Daigh, Jr., M.D.,
        Assistant Inspector General for Healthcare Inspections,
    Office of Inspector General, U.S. Department of Veterans Affairs
    Mr. Chairman and Members of the Committee, thank you for this 
opportunity to testify on aspects of patient safety that are critical 
to the delivery of quality medical care to veterans. My statement and 
comments are based on reports by the Office of Inspector General (OIG).
    While the subject of this hearing is on substantive performance 
gaps where the Department of Veterans Affairs (VA) needs to improve, I 
want to clearly state that from the body of work conducted by the OIG's 
Office of Healthcare Inspections, it is clear that VA provides veterans 
with high quality medical care that has the support of veterans and 
employees as measured by satisfaction surveys and is rated with the 
best healthcare plans in the country. That being said, VA has had 
several high profile and highly publicized incidents that naturally 
would shake the faith of those who receive care from VA. Some of the 
incidents were the result of improper reprocessing of complex medical 
equipment and others were the result of leadership failing to act when 
presented information of serious breaches of infection control 
protocols.
REUSABLE MEDICAL EQUIPMENT
    The reprocessing of reusable medical equipment (RME) is categorized 
based on the associated risk of and the level of cleaning required to 
prevent infection. Devices that enter normally sterile tissue, 
including joints and the vascular system, require sterilization to 
eliminate all forms of microbial life. Other devices, including many 
endoscopes, examine intact mucous membranes and do not ordinarily 
penetrate sterile tissue. For these devices, which are often 
constructed of materials and mechanisms that are unable to withstand 
exposure to the high temperatures or chemicals required for 
sterilization, high-level disinfection (HLD) is appropriate. HLD 
eradicates all micro-organisms ``except for small numbers of bacterial 
spores.'' \1\
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    \1\ W.A. Rutala, D.J. Weber, and the Healthcare Infection Control 
Practices Advisory Committee, Centers for Disease Control and 
Prevention, Guideline for Disinfection and Sterilization in Healthcare 
Facilities, 2008.

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OIG Reports on RME

Healthcare Inspection, Use and Reprocessing of Flexible Fiberoptic 
Endoscopes at VA Medical Facilities (June 16, 2009) and Healthcare 
Inspection. Follow-Up Colonoscope Reprocessing at VA Medical 
Facilities, September 17, 2009)

    In June 2009, we reported on difficulties in reprocessing 
colonoscopes at the Miami, Florida, VA Medical Center (VAMC) and the 
Murfreesboro, Tennessee, VAMC, which led to the notification of 2,531 
veterans at Miami and 6,805 veterans at Murfreesboro that they were at 
risk of developing the blood borne infections of hepatitis B, hepatitis 
C, and HIV. The same report details defects in reprocessing ear-nose-
throat endoscopes that resulted in 1,069 Augusta, Georgia, veterans 
being notified of their risk of contracting blood borne viral 
illnesses.
    The report includes the results from an unannounced inspection of 
VA medical centers that found more than half did not have appropriate 
standard operating procedures (SOPs) and documented evidence of 
employee training for the colonoscopes in use at the medical center. In 
a follow up inspection of 129 VA medical centers that reprocessed 
colonoscopes, we found that all had the appropriate SOPs for 
reprocessing colonoscopes and one did not have adequate documentation 
of employee training to reprocess the scopes

Healthcare Inspections, Patient Safety Issues VA Caribbean Healthcare 
System San Juan, Puerto Rico Report (March 16, 2010)

    The OIG received allegations regarding quality of care and patient 
safety related to the RME reprocessing at the VA Caribbean Healthcare 
System (the system) in San Juan, Puerto Rico. The complainant provided 
more than 137 pieces of evidence to support their allegations. In our 
March 2010 report, we substantiated multiple allegations:

      For approximately 2 years, endovaginal transducers at the 
Mayaguez Outpatient Clinic were not submitted to high-level 
disinfection as required after each patient procedure.
      Leak testing was not performed on colonoscopes in the 
Operating Room for at least 9 months, leak testing was not performed on 
laryngoscopes in Radiotherapy and at the Ponce OPC for 9 months and 3 
years respectively.
      Pre-cleaning was improperly performed on the 
laryngoscopes in Radiotherapy.
      One of the laryngoscopes had a leak while it was in 
service during this time.
      The system inaccurately certified compliance with RME 
reprocessing procedures and training on three occasions.
      Senior system leadership and responsible managers were 
aware of these issues but took no action to assess the risk to 
patients.

    As a result of our review, issue briefs (IB) on each area were 
discussed on pre-Clinical Risk Assessment Advisory Board (CRAAB) 
conference calls. Based on information provided by the system, the risk 
to patients was determined to be negligible. An Administrative 
Investigation Board (AIB) was completed after our visit to address 
management responsiveness. We recommended that the Veteran Integrated 
Service Network (VISN) Director follow up on all recommendations from 
the AIB and take appropriate administrative action.

Healthcare Inspection, Alleged Endoscope Reprocessing Issues St. Louis 
VA Medical Center St. Louis, Missouri (April 21, 2010)

    This review was conducted to determine the validity of allegations 
regarding ongoing issues in the Supply, Processing, and Distribution 
(SPD) department related to endoscope reprocessing and communication at 
the St. Louis VA Medical Center, St. Louis, Missouri.
    We substantiated:

      Endoscope reprocessing issues have been ongoing. We 
reviewed documentation related to three contaminated gastrointestinal 
(GI) endoscopes, which were identified prior to patient use. We also 
reviewed documents notifying managers that damage and repairs to 
endoscopes had increased. We requested the 2009 repair log and 
associated costs from SPD and found that a majority of the scopes that 
were damaged or needed repair belonged to the GI service.
      Breakdowns in communication of adverse events and 
outcomes existed. We found minimal documentation as well as 
communication failures for two of the three adverse event reports (AER) 
reviewed.

    In addition, we conducted an unannounced inspection of the SPD 
area. We identified several items related to reusable medical equipment 
reprocessing and staff safety that needed improvement as required by 
Veteran Health Administration (VHA) policies.
    We recommended that the AER reporting process is clearly defined, 
timely, and well-documented and that implemented action plans are 
monitored for compliance to eliminate ongoing endoscope damage and 
reprocessing issues. We also recommended that SPD meet VHA policy and 
is monitored for compliance.
    The VISN and Medical Center Directors agreed with the findings and 
recommendations. We closed this report on February 17, 2011.

Healthcare Inspection, Reprocessing of Dental Instruments, John Cochran 
Division of the St. Louis VA Medical Center, St. Louis, Missouri (March 
7, 2011)

    The purpose of this review was to determine the sequence of events 
involving alleged improperly cleaned and sterilized dental RME; errors 
in reprocessing or sterilization; actions taken to correct 
deficiencies; and decisions related to patient notification of breaches 
in dental equipment reprocessing or sterilization.
    The dental RME reprocessing issues at the John Cochran Division 
(JCD) were a long-standing problem that went unrecognized and 
unaddressed by VISN and VAMC managers. VHA self-identified the 
deficiencies and took actions to correct them; however, those actions 
did not always resolve the issues. Responsible managers did not verify 
the adequacy of RME reprocessing practices, nor did they assure that 
corrective actions were consistently implemented in response to VHA 
guidance and the Infectious Disease Program Office (IDPO) report. As a 
result, SOPs were not developed in a timely manner for the reprocessing 
of dental RME, SOPs did not always match manufacturers' instructions, 
and Dental Clinic staff had not received training on dental RME pre-
treatment or reprocessing.
    We concluded that the occurrence of a patient-to-patient 
transmission of a blood-borne infectious disease at the JCD was 
unlikely. Nevertheless, the Clinical Risk Board adhered to the process 
outlined in VHA Directive 2008-002, Disclosure of Adverse Events to 
Patients (January 18, 2008), when it recommended disclosure to 1,812 
patients potentially affected by breaches in the cleaning and 
sterilization processes. We concluded that the VAMC promptly set-up and 
staffed its Dental Review Clinic, made appropriate efforts to contact 
identified patients, and provided adequate support and follow-up to 
patients.
    We recommended that the VISN Director require the VAMC Director to 
monitor the facility's compliance with all appropriate elements of RME 
reprocessing, SOPs, staff training, and staff competencies as defined 
in relevant VHA guidance; ensure that the VISN SPD Management Board 
provides monitoring to ensure that SOPs based on manufacturer's 
instructions are in place and that staff training and competencies are 
current; and take appropriate administrative actions based on the 
findings of the Administrative Board of Investigation and IDPO report. 
The VISN and Medical Center Directors agreed with the findings and 
recommendations
Combined Assessment Program Review Results
    Despite the fact that VA leadership issued clear guidance to 
facilities on standards for reprocessing RME and that Congress held 
hearings on reprocessing failures at these sites, the OIG continues to 
find non-compliance with VA directives. Because of the persistence of 
deviations from expected performance by staff at VA facilities, a 
review of RME reprocessing practices was included in the OIG's Combined 
Assessment Program (CAP) reviews from January 1, 2010, through 
September 30, 2010. \2\ Facility results were reported at the time of 
the inspection and rolled up to present a representative view of the 
system. We found that 87 percent of the reprocessing SOPs were 
consistent with manufacturers' instructions and 92 percent were located 
within the reprocessing areas. In our observations of employees 
reprocessing equipment, the SOPs were followed 87 percent of the time. 
Documented annual training was found for 82 percent of the employees 
and item specific competencies were documented 87 percent of the time. 
Proper protective equipment was worn by employees 89 percent of the 
time. VA requires that RME activities (e.g. validation of staff 
competency, compliance with established SOPs, results of infection 
prevention and control monitoring, and risk management activities) be 
reported to the Executive Committee of the Medical Staff (ECMS). Of the 
45 facilities inspected in this CAP cycle, 37 (82 percent) had 
documented ECMS discussion of all required elements. Compliance with 
these standards at the 82 percent to 92 percent level is not sufficient 
to ensure proper patient safety.
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    \2\ Combined Assessment Program Summary Report, Evaluation of 
Reusable Medical Equipment Practices in Veterans Health Administration 
Facilities Report, March 14, 2011.
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Recommendations
    A zero defects culture is essential at all VA medical facilities to 
ensure patient safety and promote patient confidence. Employees and 
managers must establish a climate of trust to ensure that RME is only 
presented for patient use when it is in the appropriate condition.
    Reprocessing high technology equipment and endoscopes can be 
complex. The methods available to report that proper reprocessing has 
occurred are not as clear as those used to indicate proper 
sterilization has occurred. Users of devices that require reprocessing 
must work with regulators and manufacturers to produce equipment that 
reduces the likelihood of reprocessing errors. VA must consider a 
variety of novel strategies from the method of procurement to the 
support of applicable basic scientific research in its quest to insure 
providers have equipment in the proper condition when patient care is 
delivered.
    VA's Disclosure of Adverse Events \3\ policy was one of the 
Nation's earliest efforts to systematically address the issue. A recent 
article in the medical literature, The Disclosure Dilemma, Large-Scale 
Adverse Events,\4\ highlights some of the issues faced by institutions 
as they struggle to deal with the application of the limits of science 
and proper public policy. I believe it is time to have a national body 
advise VA on potential changes to this policy in light of the broad 
national experience with these complex issues.
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    \3\ VHA Directive 2008-002, Disclosure of Adverse Events to 
Patients, January 18, 2008.
    \4\ Denise M. Dudzinski, Ph.D., Philip C. Hebert, M.D., Ph.D., Mary 
Beth Foglia, R.N., Ph.D., and Thomas H. Gallagher, M.D., New England 
Journal of Medicine, The Disclosure Dilemma, Large-Scale Adverse 
Events, Volume 39, September 2, 2010.
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LEADERSHIP ISSUES
    Leadership failures may endanger patients' lives. There have been 
two recent occasions\5\ when facility staff deviated from RME 
reprocessing standards resulting in VA CRAAB reviews. Failure to comply 
with accepted infection control policies in the Dayton, Ohio, VAMC 
Dental Clinic resulted in the notification to 535 veterans that dental 
care may have put them at risk of acquiring blood borne viral 
infections.
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    \5\ Healthcare Inspection Patient Safety Issues VA Caribbean 
Healthcare System San Juan, Puerto Rico, March 16, 2010; Healthcare 
Inspection Oversight Review of Dental Clinic Issues Dayton VA Medical 
Center Dayton, Ohio, April 25, 2011.
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    In our recent report on the Dayton VAMC Dental Clinic, we concluded 
that the subject dentist did not adhere to established infection 
control guidelines and policies, and multiple dental clinic staff had 
direct knowledge of these repeated infractions. These violations of 
infection control policies placed patients at risk of acquiring 
infections including those that are blood borne.
    In our report on the VA Caribbean Healthcare System RME issues, we 
substantiated multiple allegations including that senior system 
leadership and responsible managers were aware of these issues but took 
no action to assess the risk to patients.
    In these instances, VA local leaders did not perform to the 
expected standard and placed veterans' health at risk. It is imperative 
that leaders take the appropriate actions to ensure compliance with 
policies designed to ensure patients are not placed at risk of 
preventable disease in the normal course of the delivery of patient 
care.
Recommendations
    Just as physicians have access to senior facility leaders via 
clinical department leaders and nurses have access through the Chief 
Nurse, VA clinical leaders should strive to receive unfiltered 
information from the many technicians who are critical to the daily 
delivery of quality medical care. Current lines of communication may 
not be adequate to get the technicians concerns to facility leaders. 
Ongoing discussions between the facilities leadership and the 
hospital's technicians may provide important data necessary to improve 
quality care.
    Some successful organizations recognize that the rotation of 
individuals through leadership positions or positions of special 
responsibility provide a periodic check for the organization on its 
adherence to policy. VA should consider how this management tool might 
improve performance at network offices and at medical centers.
CONCLUSION
    Clearly VA can perform better regarding RME reprocessing. Attention 
from Congress and VA senior leadership has improved processes but 
continuous attention to this issue at the medical center level will go 
a long way to easing veterans concerns about the safety of medical 
procedures and easing anxiety about having routine preventive tests 
such as colonoscopies and regular dental check-ups.
    Mr. Chairman, thank you for this opportunity and I would be pleased 
to respond to any questions that you or other Members of the Committee 
have.

                                 
              Prepared Statement of Randall B. Williamson,
      Director, Health Care, U.S. Government Accountability Office
          VA HEALTHCARE: Weaknesses in Policies and Oversight
       Governing Medical Equipment Pose Risks to Veterans' Safety
    Chairman Miller, Ranking Member Filner, and Members of the 
Committee:
    I am pleased to be here today as you discuss patient safety 
incidents at Department of Veterans Affairs (VA) medical centers and 
potential strategies to address the underlying causes of those 
incidents. VA operates one of the largest integrated healthcare 
delivery systems in the United States, providing care to over 5.5 
million veterans annually. Organized into 21 Veterans Integrated 
Service Networks (VISN), VA's healthcare system includes 153 VA medical 
centers (VAMC) nationwide that offer a variety of outpatient, 
residential, and inpatient services.\1\ In providing healthcare 
services to veterans, clinicians at VAMCs use reusable medical 
equipment (RME), which is designed to be reused for multiple patients 
and includes such equipment as endoscopes \2\ and some surgical and 
dental instruments. Because RME is used when providing care to multiple 
veterans, this equipment must be reprocessed, that is, cleaned and 
disinfected or sterilized between uses. VA has established requirements 
for VAMCs to follow when reprocessing RME,\3\ which are designed, in 
part, to help ensure the safety of the veterans who receive care at 
VAMCs.
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    \1\ The management of VAMCs is decentralized to 21 VISNs.
    \2\ An endoscope is a device with a light attached that is used to 
look inside a body cavity or organ.
    \3\ VA Handbook 7176, Supply, Processing, and Distribution (SPD) 
Operational Requirements (Aug. 16, 2002); VHA Directive 2009-004, Use 
and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health 
Administration Facilities (Feb. 9, 2009); and VHA Directive 2009-031, 
Improving Safety in the Use of Reusable Medical Equipment Through 
Standardization of Organizational Structure and Reprocessing 
Requirements (June 26, 2009).
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    My testimony today, based on our May 2011 report,\4\ which is being 
released today, examines issues related to veterans' safety, including 
(1) selected reprocessing requirements established in VA policies, 
based on their relevance to patient safety incidents and (2) VA's 
oversight of VAMCs' compliance with these selected requirements.
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    \4\ See GAO, VA Health Care: Weaknesses in Policies and Oversight 
Governing Medical Supplies and Equipment Pose Risks to Veterans' 
Safety, GAO-11-391 (Washington, D.C.: May 2011).
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    To examine VA reprocessing requirements, we reviewed relevant VA 
policies and from these policies, we judgmentally selected the 
following two types of reprocessing requirements that we determined 
were relevant to patient safety incidents that were identified at 
certain VAMCs. \5\
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    \5\ We reviewed applicable VA policies, including VHA Directive 
2009-031, Improving Safety in the Use of Reusable Medical Equipment 
Through Standardization of Organizational Structure and Reprocessing 
Requirements; VHA Directive 2009-004, Use and Reprocessing of Reusable 
Medical Equipment (RME) in Veterans Health Administration Facilities; 
and VA Handbook 7176, Supply, Processing, and Distribution (SPD) 
Operational Requirements.
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    Training requirements. To ensure that RME is reprocessed in 
accordance with manufacturers' guidelines, VA requires that each VAMC 
develop device-specific training for reprocessing RME. To develop this 
training, VA requires VAMCs to create device-specific standard 
operating procedures (SOP), which provide step-by-step instructions for 
reprocessing. VA also requires VAMCs to assess staff annually on their 
competence to reprocess RME in accordance with these SOPs.
    Operational requirements. To ensure that reprocessing activities 
are performed safely and that RME is reprocessed correctly, VA policies 
establish operational requirements for VAMCs, which include that VAMC 
staff must monitor sterilizers to ensure that they are functioning 
properly, use personal protective equipment when performing 
reprocessing activities, and segregate dirty and clean RME.
    After selecting these requirements for our review, we judgmentally 
selected six VAMCs from the following locations to visit: Albany, New 
York; Cheyenne, Wyoming; Detroit, Michigan; Miami, Florida; Palo Alto, 
California; and St. Louis, Missouri. These VAMCs represent different 
surgical complexity groups,\6\ sizes of veteran populations served, and 
geographic regions.\7\ At these six VAMCs, we examined the adequacy of 
the selected reprocessing requirements to help the facilities ensure 
the safety of veterans who received care at these facilities. To do 
this, we examined how the selected requirements were implemented and 
whether or to what extent these requirements directly or indirectly 
created a potential risk to veterans' safety. We reviewed applicable 
VAMC committee meeting minutes \8\ and other documentation on the 
implementation of these requirements. We also interviewed VAMC 
officials who were responsible for implementing the selected 
requirements to determine whether these requirements are adequate to 
help ensure veterans' safety.
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    \6\ VA assigns each VAMC a complexity score between 1 and 3, with 
level 1 being the most complex, using a facility complexity model. That 
model uses multiple variables to measure facility complexity arrayed 
along four categories, namely patient population served, clinical 
services offered, education and research complexity, and administrative 
complexity.
    \7\ Each of the six VAMCs we visited is located within a different 
VISN.
    \8\ We reviewed minutes from the following committees: commodity 
standards, equipment, medical executive, infection control, and RME.
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    To examine VA's oversight of VAMCs' compliance with the selected 
reprocessing requirements, we reviewed VA's oversight of these 
requirements and evaluated whether this oversight provides VA with 
adequate information to identify and address noncompliance. As part of 
this review, we assessed VA's oversight in the context of Federal 
standards for internal control for monitoring.\9\ The internal control 
for monitoring refers to an agency's ability to assure that ongoing 
review and supervision activities are conducted, with the scope and 
frequency depending on the assessment of risks; deficiencies are 
communicated to at least one higher level of management; and actions 
are taken in response to findings or recommendations within established 
timelines. We interviewed officials responsible for overseeing VAMCs' 
compliance with the requirements we selected for review from VA 
headquarters, VA's Office of Inspector General (OIG), and six VISNs 
that are responsible for overseeing compliance with the requirements we 
selected for review at the VAMCs we visited. In addition, we obtained 
and reviewed relevant documents regarding VA oversight, including 
internal reports, VAMCs' plans to correct problems identified through 
oversight activities, and policy memorandums.
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    \9\ See GAO, Standards for Internal Control in the Federal 
Government, GAO/AIMD-00-21.3.1 (Washington, D.C.: November 1999) and 
GAO, Internal Control Management and Evaluation Tool, GAO-01-1008G 
(Washington, D.C.: August 2001).
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    We conducted this performance audit from March 2010 to May 2011 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives.
    In summary, we found that the VA reprocessing requirements we 
selected for review are inadequate to help ensure the safety of 
veterans who receive care at VAMCs. Although VA requires VAMCs to 
develop device-specific training for staff on how to correctly 
reprocess RME, it has not specified the types of RME for which this 
training is required. Furthermore, VA has provided conflicting guidance 
to VAMCs on how to develop device-specific training on reprocessing 
RME.\10\ This lack of clarity may have contributed to delays in 
developing the required training. Without appropriate training on 
reprocessing, VAMC staff may not be reprocessing RME correctly, which 
poses potential risks to veterans' safety. VA headquarters officials 
told us that VA has plans to develop training for certain RME, but VA 
lacks a timeline for developing this training.
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    \10\ According to VA headquarters officials, certain RME are 
difficult to reprocess because they need to be fully disassembled in 
order to be reprocessed correctly, so developing device-specific 
training for reprocessing these items is important to help ensure 
veterans' safety.
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    We also found that despite changes to improve VA's oversight of 
VAMCs' compliance with selected reprocessing requirements, weaknesses 
still exist. These weaknesses render VA unable to systematically 
identify and address noncompliance with the requirements, which poses 
potential risks to the safety of veterans. Although VA headquarters 
receives information from the VISNs on any noncompliance they identify, 
as well as VAMCs' corrective action plans to address this 
noncompliance, VA headquarters does not analyze this information to 
inform its oversight. According to VA headquarters officials, VA 
intends to develop a plan for analyzing this information to 
systematically identify areas of noncompliance that occur frequently, 
pose high risks to veterans' safety, or have not been addressed across 
all VAMCs.
    To address the inadequacies we identified in selected VA 
reprocessing requirements, GAO recommends that VA develop and implement 
an approach for providing standardized training for reprocessing all 
critical and semi-critical RME to VAMCs and hold VAMCs accountable for 
implementing this training. To address the weaknesses in VA's oversight 
of VAMCs' compliance with selected requirements, GAO recommends that VA 
use information on noncompliance identified by the VISNs and 
information on VAMCs' corrective action plans to identify areas of 
noncompliance across all 153 VAMCs and take action to improve 
compliance in those areas.
Selected VA Reprocessing Requirements Are Inadequate to Help Ensure 
        Veterans' Safety
    We found that the VA reprocessing requirements we selected for 
review are inadequate to help ensure veterans' safety.
    Lack of specificity about types of RME that require device-specific 
training. The VA reprocessing requirements we reviewed do not specify 
the types of RME for which VAMCs must develop device-specific training. 
This inadequacy has caused confusion among VAMCs and contributed to 
inconsistent implementation of training for reprocessing. While VA 
headquarters officials told us that the training requirement is 
intended to apply to RME classified as critical, such as surgical 
instruments, and semi-critical, such as certain endoscopes,\11\ 
officials from five of the six VAMCs we visited told us that they were 
unclear about the RME for which they were required to develop device-
specific training.
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    \11\ RME is generally categorized into critical, semi-critical, or 
non-critical items based on the degree of risk for infection involved 
in use of the item. Critical items, such as surgical instruments, are 
those that enter sterile tissue or the vascular system and require 
sterilization because they confer a high risk of infection. Semi-
critical items, such as certain endoscopes, are those that contact 
mucous membranes or non-intact skin and minimally require high-level 
disinfection. Non-critical items, such as wheelchairs, are those that 
come into contact with intact skin and may be cleaned with low-level 
disinfectants.
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    Officials at one VAMC we visited told us that they did not develop 
all of the required reprocessing training for critical RME, such as 
surgical instruments, because they did not understand that they were 
required to do so. Officials at another VAMC we visited also told us 
that they had begun to develop device-specific training for 
reprocessing non-critical RME, such as wheelchairs, even though they 
had not yet fully completed device-specific training for more critical 
RME. Because these two VAMCs had not developed the appropriate device-
specific training for reprocessing critical and semi-critical RME, 
staff at these VAMCs may not have been reprocessing all RME properly, 
which potentially put the safety of veterans receiving care at these 
facilities at risk.
    Conflicting guidance on the development of RME reprocessing 
training. While VA requires VAMCs to develop device-specific training 
on reprocessing RME, VA headquarters officials provided VAMCs with 
conflicting guidance on how they should develop this training. For 
example, officials at three VAMCs we visited told us that certain VA 
headquarters or VISN officials stated that this device-specific 
training should very closely match manufacturer guidelines in one case 
verbatim, while other VA headquarters or VISN officials stated that 
this training should be written in a way that could be easily 
understood by the personnel responsible for reprocessing RME. This 
distinction is important, since VAMC officials told us that some of the 
staff responsible for reprocessing RME may have difficulty following 
the more technical manufacturers' guidelines.\12\ In part because of 
VA's conflicting guidance, VAMC officials told us that they had 
difficulty developing the required device-specific training and had to 
rewrite the training materials multiple times for RME at their 
facilities. Officials at five of the six VAMCs also told us that 
developing the device-specific training for reprocessing RME was both 
time consuming and resource intensive.
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    \12\ VA officials stated that manufacturer guidelines for 
reprocessing RME may be technically complex and may include steps that 
staff at VAMCs are unable to follow. For example, these officials 
stated that guidelines from RME manufacturers may require the use of a 
specific disinfectant that is not available in the United States. The 
Food and Drug Administration has responsibility for overseeing RME, 
including the guidelines written by manufacturers for reprocessing 
these items.
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    VA's lack of specificity and conflicting guidance regarding its 
requirement to develop device-specific training for reprocessing RME 
may have contributed to delays in developing this training at several 
of the VAMCs we visited. Officials from three of the six VAMCs told us 
that that they had not completed the development of device-specific 
training for RME since VA established the training requirement in July 
2009. As of October 2010, 15 months after VA issued the policy 
containing this requirement, officials at one of the VAMCs we visited 
told us that device-specific training on reprocessing had not been 
developed for about 80 percent of the critical and semi-critical RME in 
use at their facility.
    VA headquarters officials told us that they are aware of the lack 
of specificity and conflicting guidance provided to VAMCs regarding the 
development of training for reprocessing RME and were also aware of 
inefficiencies resulting from each VAMC developing its own training for 
reprocessing types of RME that are used in multiple VAMCs. In response, 
VA headquarters officials told us that they have made available to all 
VAMCs a database of standardized device-specific training developed by 
RME manufacturers for approximately 1,000 types of RME and plan to 
require VAMCs to implement this training by June 2011. The officials 
also told us that VA headquarters is planning to develop device-
specific training available to all VAMCs for certain critical and semi-
critical RME for which RME manufacturers have not developed this 
training, such as dental instruments. However, as of February 2011, VA 
headquarters had not completed the development of device-specific 
training for these RME and has not established plans or corresponding 
timelines for doing so.
Despite Changes Intended to Improve VA's Oversight of VAMCs' Compliance 
        with Selected Reprocessing Requirements, Weaknesses Continue to 
        Exist
    We found that VA recently made changes to its oversight of VAMCs' 
compliance with selected reprocessing requirements; however, this 
oversight continues to have weaknesses. Beginning in fiscal year 2011, 
VA headquarters directed VISNs to make three changes intended to 
improve its oversight of these reprocessing requirements at VAMCs.\13\
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    \13\ VA headquarters generally delegates responsibility for this 
oversight to the VISNs. In addition to oversight conducted by the 
VISNs, some entities within VA headquarters conduct oversight of VAMCs' 
compliance with VA reprocessing requirements, including those we 
selected for review. Specifically, VA's OIG and Sterile Processing 
Department conduct site visits to investigate allegations of VAMC 
noncompliance with VA reprocessing requirements. In addition, since 
around 2005, VA's System-wide Ongoing Assessment and Review Strategy 
has included reviews of the selected VA reprocessing requirements as 
part of broader reviews of VAMC compliance with VA policies in 
preparation for external accreditation reviews approximately every 3 
years. In 2010, VA's OIG also conducted reviews of the selected VA 
reprocessing requirements as part of broader ongoing reviews of VAMC 
compliance with VA policies.

      VA headquarters recently required VISNs to increase the 
frequency of site visits to VAMCs, from one to three unannounced site 
visits per year, as a way to more quickly identify and address areas of 
noncompliance with selected VA reprocessing requirements.
      VA headquarters also recently required VISNs to begin 
using a standardized assessment tool to guide their oversight 
activities.\14\ According to VA headquarters officials, requiring VISNs 
to use this assessment tool will enable the VISNs to collect consistent 
information on VAMCs' compliance with VA's reprocessing requirements. 
Before VA established this requirement, the six VISNs that oversee the 
VAMCs we visited often used different assessment tools to guide their 
oversight activities. As a result, they reviewed and collected 
different types of information on VAMCs' compliance with these 
requirements.
---------------------------------------------------------------------------
    \14\ VA headquarters officials told us that they may refine this 
assessment tool over time.
---------------------------------------------------------------------------
      VISNs are now required to report to VA headquarters 
information from their site visits. Specifically, following each 
unannounced site visit to a VAMC, VISNs are required to provide VA 
headquarters with information on the facility's noncompliance with VA's 
reprocessing requirements and VAMCs' corrective action plans to address 
areas of noncompliance. Prior to fiscal year 2011, VISNs were generally 
not required to report this information to VA headquarters.\15\
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    \15\ While VISNs were not generally required to report to VA 
headquarters information on VAMCs' noncompliance with VA's reprocessing 
requirements, VISNs were required to report to VA headquarters 
information about noncompliance that may have resulted in harm to 
veterans. VA headquarters officials told us that following a review of 
that information and collection of additional information as needed, a 
panel of experts would determine whether the noncompliance identified 
in the reviews resulted in risks to veterans' safety and, if so, 
whether veterans should be notified. See VHA Directive 2008-002, 
Disclosure of Adverse Events to Patients (Washington, D.C.: Jan. 18, 
2008).

    Despite the recent changes, VA's oversight of its reprocessing 
requirements, including those we selected for review, has weaknesses in 
the context of the Federal internal control for monitoring. Consistent 
with the internal control for monitoring, we would expect VA to analyze 
this information to assess the risk of noncompliance and ensure that 
noncompliance is addressed. However, VA headquarters does not analyze 
information to identify the extent of noncompliance across all VAMCs, 
including noncompliance that occurs frequently or poses high risks to 
veterans' safety. As a result, VA headquarters has not identified the 
extent of noncompliance across VAMCs with, for example, VA's 
operational reprocessing requirement that staff use personal protective 
equipment when performing reprocessing activities, which is key to 
ensuring that clean RME are not contaminated by coming into contact 
with soiled hands or clothing. Three of the six VAMCs we visited had 
instances of noncompliance with this requirement. Similarly, because VA 
headquarters does not analyze information from VAMCs' corrective action 
plans to address noncompliance with VA reprocessing requirements, it is 
unable to confirm, for example, whether VAMCs have addressed 
noncompliance with its operational reprocessing requirement to separate 
clean and dirty RME. Two of the six VAMCs we visited had not resolved 
noncompliance with this requirement and, as a result, are unable to 
ensure that clean RME does not become contaminated by coming into 
contact with dirty RME.
    VA headquarters officials told us that VA plans to address the 
weaknesses we identified in its oversight of VAMCs' compliance with 
reprocessing requirements. Specifically, VA headquarters officials told 
us that they intend to develop a systematic approach to analyze 
oversight information to identify areas of noncompliance across all 
VAMCs, including those that occur frequently, pose high risks to 
veterans' safety, or have not been addressed in a timely manner.\16\ 
While VA has established a timeline for completing these changes, 
certain VA headquarters officials told us that they are unsure whether 
this timeline is realistic due to possible delays resulting from VA's 
ongoing organizational realignment, which had not been completed as of 
April 6, 2011.\17\
---------------------------------------------------------------------------
    \16\ VA headquarters officials also told us that a temporary staff 
member was assigned in March 2011 to begin reviewing some information 
from VISNs' oversight activities. Specifically, that staff member will 
be responsible for reviewing whether VAMCs have developed the required 
device-specific training for reprocessing RME and the extent to which 
VAMCs are utilizing flash sterilization, a sterilization technique that 
should be used only in limited circumstances.
    \17\ As part of this realignment, VA headquarters is establishing a 
new position within the Office of the Deputy Under Secretary for Health 
for Operations and Management, which will be responsible for overseeing 
certain departments, including VA headquarters' Sterile Processing 
Department.
---------------------------------------------------------------------------
    In conclusion, weaknesses exist in VA's policies for reprocessing 
RME that create potential safety risks to veterans. VA's lack of 
specificity and conflicting guidance for developing device-specific 
training for reprocessing RME has led to confusion among VAMCs about 
which types of RME require device-specific training and how VAMCs 
should develop that training. This confusion has contributed to some 
VAMCs not developing training for their staff for some critical and 
semi-critical RME.
    Moreover, weaknesses in oversight of VAMCs' compliance with the 
selected reprocessing requirements do not allow VA to identify and 
address areas of noncompliance across VAMCs, including those that occur 
frequently, pose high risks to veterans' safety, or have not been 
addressed by VAMCs. Correcting inadequate policies and providing 
effective oversight of reprocessing requirements consistent with the 
Federal standards for internal control is essential for VA to prevent 
potentially harmful incidents from occurring.
    To help ensure veterans' safety through VA's reprocessing 
requirements, we are making two recommendations in our report. We 
recommend that the Secretary of Veterans Affairs direct the Under 
Secretary for Health to take the following actions:

      Develop and implement an approach for providing 
standardized training for reprocessing all critical and semi-critical 
RME to VAMCs. Additionally, hold VAMCs accountable for implementing 
device-specific training for all of these RME.
      Use the information on noncompliance identified by the 
VISNs and information on VAMCs' corrective action plans to identify 
areas of noncompliance across all 153 VAMCs, including those that occur 
frequently, pose high risks to veterans' safety, or have not been 
addressed, and take action to improve compliance in those areas.

    In responding to a draft of the report from which this testimony is 
based, VA concurred with these recommendations.
    Chairman Miller, Ranking Member Filner, this concludes my prepared 
statement. I would be happy to respond to any questions you or other 
Members of the Committee may have.
Contacts and Acknowledgments
    For further information about this testimony, please contact 
Randall B. Williamson at (202) 512-7114 or [email protected] Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this testimony. Individuals who made 
key contributions to this testimony include Mary Ann Curran, Assistant 
Director; Kye Briesath; Krister Friday; Melanie Krause; Lisa Motley; 
and Michael Zose.

                                 
       Prepared Statement of Michael Bell, M.D., Deputy Director,
 Division of Healthcare Quality Promotion Centers for Disease Control 
                                  and
        Prevention, U.S. Department of Health and Human Services
    Good morning Chairman Miller, Ranking Member Filner and other 
distinguished Members of the Committee. I am Dr. Michael Bell, Deputy 
Director of the Division of Healthcare Quality Promotion at the Centers 
for Disease Control and Prevention (CDC). I am pleased to be here to 
discuss the prevention of healthcare-associated infections (HAIs) and 
ensuring safe healthcare nationwide.
    Healthcare associated infections are infections that patients 
acquire while receiving care. They include a variety of infections 
ranging from those related to specialized intensive care procedures to 
infections caused by lapses in basic safe practices, like re-using 
disposable syringes or inappropriate reprocessing of equipment. CDC 
estimates that approximately 1 in 20 hospital patients have HAIs. These 
infections are associated with increased mortality and greater cost of 
care; and can occur in any healthcare setting--hospitals, long-term 
care, dialysis clinics, ambulatory surgical centers, and even doctors' 
offices. As complex care is increasingly delivered in non-hospital 
settings, we are seeing a concomitant increase in potentially life-
threatening infections related to care outside of hospitals. Infections 
caused by lapses in basic infection control are unacceptable. We know 
how to protect patients from these events; they can and must be 
prevented.
    Based on CDC data, the four most frequent infections related to 
specialized care procedures accounting for approximately three quarters 
of HAIs are: 1) urinary tract infections; 2) surgical site infections; 
3) bloodstream infections; and 4) pneumonia. These infections are 
caused by both common pathogens such as Staphylococcus aureus, 
including Methicillin-resistant Staphylococcus aureus (MRSA), and by 
emerging pathogens such as drug-resistant Klebsiella pneumoniae. In 
addition, we continue to see egregious failures in basic infection 
control and safety practices (e.g., using the same syringe to 
administer medication to more than one patient) that have resulted in 
transmission of blood borne and other pathogens (i.e., hepatitis C 
virus, [HCV], hepatitis B virus [HBV]). HAIs in hospitals alone result 
in excess healthcare costs of an estimated $26 to $33 billion each 
year. Yet, most HAIs are preventable. HHS and its public and private 
sector partners are working together to eliminate these costly and 
deadly infections. HHS recently launched the Partnership for Patients: 
Better Care, Lower Costs, a new public-private partnership that will 
help improve the quality, safety and affordability of healthcare for 
all Americans. The Partnership for Patients brings together leaders of 
major hospitals, employers, health plans, physicians, nurses, and 
patient advocates along with State and Federal Governments in a shared 
effort to make hospital care safer, more reliable, and less costly.
    The Centers for Disease Control and Prevention, working with 
several other agencies in the U.S. Department of Health and Human 
Services, has taken a lead role in addressing the important public 
health challenge of preventing HAI's by identifying and implementing 
prevention strategies, providing guidelines for prevention, monitoring 
HAIs and tracking prevention progress, and detecting and responding to 
emerging threats.
    The HHS Action Plan to Prevent HAIs sets specific targets for 
monitoring and preventing HAIs nationally and represents a national 
blueprint for promoting HAI prevention. CDC has played an integral role 
in the HHS led effort to develop and implement the HHS Action Plan, 
including chairing the Prevention and Implementation working group and 
co-chairing the Information Systems and Technology working group. Since 
the release of the initial HHS Action Plan, CDC has collaborated 
closely with the HHS Assistant Secretary for Health, the Agency for 
Healthcare Research and Quality (AHRQ), the Centers for Medicare and 
Medicaid Services (CMS), the Department of Veterans Affairs (VA), and 
other Federal agencies to expand and implement the HHS Action Plan to 
include ambulatory surgical centers and hemodialysis centers.
    There has been significant progress in several areas; however more 
work is needed to ensure that appropriate infection control practices 
are adhered to in all healthcare settings. The VA has been an important 
partner in implementing HHS HAI prevention initiatives. However, recent 
infection control lapses, such as those at VA facilities in Dayton OH, 
St. Louis MO, and Miami FL, demonstrate the need for constant 
vigilance.
    Today, I will focus my remarks on 3 specific areas: 1) the issue of 
basic infection control in healthcare, including CDC's efforts to 
prevent them; 2) CDC's collaborations with the VA related to HAIs; and 
3) recommended strategies to halt improper practices when they are 
identified and to notify patients that were exposed to those practices.
Healthcare-Associated Infections Related to Failure to Maintain Basic 
        Infection Control
    CDC has worked with State and local health departments to identify 
numerous breaches in basic infection control practices in recent years. 
Infections acquired through lapses in basic infection control practices 
are generally through an intermediate device or material. A medical 
device (e.g., syringe, needle, lancet) or medication becomes 
contaminated with an infectious agent and the infectious agent is then 
passed to a previously uninfected patient through inappropriate 
exposure to the contaminated material. Examples of improper practices 
include:

      Using the same syringe to administer medication to more 
than one patient;
      Accessing a shared medication vial with a syringe that 
has already been used to administer medication to a patient; and
      Performing finger stick blood sampling with a reused 
lancing device or checking blood glucose levels with a blood-
contaminated glucose meter.
      Improper reprocessing (i.e., cleaning and disinfection) 
of endoscopes
      Improper reprocessing and sterilization of medical 
equipment (e.g., surgical equipment)
      Improper reuse of medical devices (e.g., syringes, 
prostate biopsy needle guides)

    These unacceptable practices put patients at risk of infectious and 
non-infectious adverse events and have been associated with a wide 
variety of procedures. Unfortunately, these practices are occurring 
across the healthcare spectrum and in non-acute care settings outside 
of hospitals, where infection control capacity is often less extensive 
and oversight more limited.
    Healthcare should never be a conduit for transmission of 
infections. Basic infection control practices have long been 
established as part of the evidence-based and common sense precautions 
that are necessary to prevent transmission of pathogens.
CDC's Efforts to Prevent HAIs Due to Failure To Maintain Basic 
        Infection Control
    Leading the Nation's efforts to protect patients from transmission 
of pathogens due to lapses in infection control during healthcare 
delivery, CDC is engaged in a number of efforts to eliminate these 
events, including:

      development and implementation of HAI prevention 
guidelines,
      development of survey tools to evaluate facilities' 
adherence to infection control practices,
      identifying and responding to new and emerging threats to 
patient safety,
      educating healthcare providers and patients in basic 
infection control, and
      promoting development of safer medical devices.
Development and Implementation of Infection Prevention Recommendations
    CDC, working with the HHS Healthcare Infection Control Practices 
Advisory Committee (HICPAC), develops evidence-based guidelines for HAI 
prevention. Key existing guidelines include: (1) the Guideline for 
Disinfection and Sterilization in Healthcare Facilities, 2008, 
presenting evidence-based recommendations on the preferred methods for 
cleaning, disinfection and sterilization of medical equipment and for 
cleaning and disinfecting the healthcare environment, (2) the 
Guidelines for Environmental Infection Control in Health-Care 
Facilities, 2003, a compilation of recommendations for the prevention 
and control of infectious diseases that are associated with healthcare 
environments, and (3) the 2007 Guideline for Isolation Precautions: 
Preventing Transmission of Infectious Agents in Healthcare Settings. 
CDC and HICPAC also developed summary recommendations specifically for 
ambulatory care targeting basic infection control practices that should 
be used in all healthcare settings. CDC has worked with professional 
associations to reach out to healthcare professionals and is 
collaborating with CMS to incorporate CDC guidelines into CMS practice 
requirements.
Tools To Improve Basic Infection Control
    CDC develops tools to translate CDC and HICPAC guidelines into 
practice. For example, CDC is improving basic infection control 
practices through collaborations with CMS to expand survey and 
oversight capacity of non-acute healthcare settings. CDC and CMS worked 
together to develop a new tool that state inspectors can use to better 
ensure the quality of care in ambulatory surgical centers (ASCs); use 
of the tool has been expanded nationwide. In a 2008 Federal survey of 
ASCs, 68 percent of 68 surveyed had noncompliance with the infection 
control requirements in the Medicare ASC health and safety standards. 
CMS has found infection control problems in ASCs to be both common and 
egregious, ranging from failure to clean equipment between patients and 
re-use of single-dose vials of medication for multiple patients. CDC is 
working with CMS to expand incorporation of basic infection control 
content into CMS interpretive guidance for their conditions of 
coverage. The tool has now been adapted for use in nursing homes and 
used to assess infection control practices in Nevada nursing homes. CDC 
continues to work with CMS to develop similar tools for use in acute 
care and other healthcare settings.

    Breaches in basic infection control practices have put greater 
focus on the authorities and role of State and local health departments 
in ensuring patient safety. State licensure boards can promote ongoing 
training and certification as a part of licensure requirements for 
healthcare professionals. State health departments play critical public 
health roles in preventing harm due to incorrect practices, including 
issuance of cease and desist notices when necessary.
Identifying and Responding To New and Emerging Threats
    CDC serves as a national and global leader in the investigation and 
control of HAI outbreaks. Through its investigations, CDC identifies 
problems, develops new prevention strategies, and works with partner 
agencies such as the Food and Drug Administration (FDA) to implement 
policy changes. Investigation of single suspect cases has in many 
instances led to the detection of sizable outbreaks, highlighting the 
point that recognized outbreaks are usually only the tip of the 
iceberg. Outbreaks often reveal unsafe practices and can require large 
scale patient notifications (as described below). Countless infections 
were prevented because of interventions that were implemented in 
collaboration with FDA and other partners to stop these outbreaks, 
including the identification and recall of contaminated or defective 
products, changes in device construction, revised recommendations for 
device use, closure of non-compliant facilities, and recommendation of 
new practices to prevent additional infections.
    CDC deploys experts including healthcare epidemiologists, 
infectious disease physicians, and laboratory scientists to assess 
healthcare settings, collect and analyze data, evaluate practices, and 
perform microbiologic testing in response to a recognized outbreak or 
problem. CDC has assisted with laboratory testing of patients put at 
risk for hepatitis. Information from these investigations not only 
serves to control the immediate problem, but also has a direct impact 
on future HAI prevention nationwide. Experience from outbreak 
investigations also contributes to refinement of infection control 
guidelines and improvements in HAI tracking.
    Viral hepatitis is a reportable condition in all States, but our 
ability to detect transmission in healthcare settings through this 
routine surveillance is limited because the system relies on passive 
reporting and in many cases we cannot evaluate how patients became 
infected. Therefore, CDC provides funding to several States to conduct 
enhanced viral hepatitis surveillance through the Emerging Infections 
Program (EIP). A case control study was conducted as part of the EIP 
activity to examine the role of healthcare exposures among older adults 
with acute hepatitis B and C. Results of this study indicate that viral 
hepatitis infections transmitted to individual patients in healthcare 
settings represent a significant but under-recognized problem.
Promotion of Infection Control Through Education
    CDC is working with partners through the Safe Injection Practices 
Coalition (SIPC), a partnership of healthcare-related organizations, 
professional organizations, and patient advocacy groups, that promote 
safe injection practices in healthcare settings. Through CDC funding, 
the SIPC developed the One & Only Campaign--a public health education 
and awareness campaign--aimed at both healthcare providers and patients 
to advance and promote safe injection practices and implemented the 
campaign in Nevada, New York, and New Jersey. In addition, CDC has 
disseminated almost 5,000 DVDs and logged over 20,000 online views of a 
10-minute educational video for healthcare providers on safe injection 
practices launched in collaboration with the SIPC.
Promoting Development of Safer Medical Devices
    CDC is working to promote innovation and development of product and 
marketing improvements to protect patients. For example after the 
identification of several outbreaks of viral hepatitis resulting from 
shared use of fingerstick (lancing) devices and point of care blood 
testing devices for glucose monitoring, in August 2010, the FDA, CDC, 
and CMS issued clinical reminders and public health notifications 
highlighting the risk of transmission of disease from these devices. 
FDA is working with manufacturers to ensure that adequate labeling and 
instructions for use are provided to healthcare personnel so that they 
can adhere to recommended practices.
CDC's Collaborations With the VA To Prevent Infections
    CDC's efforts to eliminate HAIs are amplified through close 
collaborations with a range of Federal agencies, including the VA. The 
VA has been directly involved with CDC in many of the efforts outlined 
above. A senior representative from the VA serves as an ex-officio 
member of HICPAC, and as such is engaged in the ongoing development of 
infection prevention guidelines and strategies for surveillance and 
prevention of HAIs. The VA is also engaged in HHS inter-agency 
initiatives to improve and expand HAI prevention efforts, including the 
HHS Steering Committee for the Prevention of Healthcare-Associated 
Infections, of which the VA is an active member. CDC has worked with 
the VA in the investigation and response to lapses in basic infection 
control at VA medical facilities.
    The VA hospital system has been a leader in implementing CDC and 
HICPAC infection prevention recommendations. CDC has directly partnered 
with the VA to implement prevention initiatives resulting in a 60 
percent reduction of MRSA in VA facilities over a 32 month period, 
initially as a pilot project at the local level and ultimately 
translated into regional and national programs. CDC is working with 
several groups to assess the effectiveness of several other successful 
implementation strategies. These and other prevention implementation 
examples demonstrate the savings in lives and healthcare costs that can 
result from national implementation of evidence-based HAI prevention 
programs.
When Infections Occur
    The ultimate goal is to ensure that all healthcare is delivered 
safely across the spectrum of healthcare delivery; however, when an 
infection control failure is identified, there is a need to notify 
patients who might have been exposed and to protect other patients from 
harm. During the past decade, over 120,000 patients had to be notified 
of the need to seek testing in the context of two dozen incidents and 
outbreaks involving unsafe injections; additional patients have been 
notified of risks associated with other errors, such as improper 
sterilization of equipment. In addition to Federal oversight and 
payment policies to drive prevention of unsafe practices, local and 
State authorities are necessary to temporarily or permanently halt 
unsafe medical practices. Once halted, strategies for identifying 
exposed individuals are needed so that those put at risk by incorrect 
practices can be notified and provided care.
Patient Notifications
    When failures of infection control result in a need to notify 
patients who were put at risk, such notifications and the accompanying 
diagnostic testing can be resource and labor intensive and are not 
without potential harm to patients notified. Decisions regarding 
notification of exposed patients when there is no evident disease 
transmission are challenging. CDC has engaged diverse partners that 
include State and local health departments, patient advocates, public 
health professionals, ethicists, healthcare industry representatives, 
and the Safe Injection Practices Coalition to discuss and obtain input 
on the ethical and communication issues related to such patient 
notification. CDC also hosted six focus groups in New York and Atlanta 
to identify best practices for notification. CDC's Public Health Ethics 
Committee also informed the process.
    Based on the process described, CDC has developed recommendations 
for determining whether patient notification should be initiated and 
how best to do so. This includes evaluation of the problem in order to 
classify it as Category A: a gross error or demonstrated high-risk 
practice (e.g., reuse of needles or syringes between patients or use of 
contaminated syringes to access shared medication vials), or Category 
B: an error with lower likelihood of blood exposure (e.g., endoscope 
reprocessing errors). Patient notifications are indicated for Category 
A. When an error is classified as Category B and there is no known 
transmission of blood borne or other pathogens, decisions should be 
based on several factors, including the risk of infection, the duty to 
warn versus the potential harm to patients from the notification, and 
addressing public concerns.
    CDC is currently developing a patient notification communications 
toolkit based on the information gathered through the process above. 
The toolkit will contain resources for developing documents for patient 
notification (e.g., sample notification letters, sample patient test 
results letter, resources for risk communication); establishing 
communication resources (e.g., setting up a call center); planning 
media and communication strategies (e.g., sample press release); and 
best practices for patient notification (e.g. planning the release of 
media and notification letters, communicating with key stakeholders and 
partners).
    CDC has met with and continues to work with the VA to share CDC's 
recommended practices for patient notifications.
Conclusion
    Ensuring that appropriate infection control practices are adhered 
to in all healthcare settings is a priority for CDC. Public health 
plays an important role in ensuring a unified approach through 
systematic implementation of prevention practices, monitoring to detect 
problems, outbreak investigation and control, oversight, education, and 
research. As healthcare continues to grow in complexity and is 
increasingly provided in outpatient settings such as ambulatory 
surgical centers, dialysis centers, and nursing homes, where infection 
control programs and oversight are generally less rigorous, outbreaks 
from transmission of pathogens through lapses in basic infection 
control practices have grown. As a result, CDC has undertaken a number 
of efforts to evaluate the problem and develop prevention strategies so 
that these errors do not recur. Many of these efforts are in 
collaboration with diverse partners, including the VA, allowing for 
broad implementation of recommended practices.
    As we continue to work toward elimination of HAIs, new healthcare 
settings and changing technology will create new challenges and will 
require continued vigilance. CDC continues to strive to address those 
challenges and ensure that patients are safe in every healthcare 
setting. Infections caused by lapses in basic infection control are 
unacceptable. We know how to protect patients from these events; they 
can and must be prevented.
    Thank you for the opportunity to testify today; I am happy to take 
any questions you may have.
                                 
    Prepared Statement of Anthony D. Watson, BS, MS, MBA, Director,
 Division of Anesthesiology, General, Hospital, Infection Control, and
  Dental Devices, Office of Device Evaluation, Center For Devices and
           Radiological Health, Food and Drug Administration,
              U.S. Department of Health and Human Services
Introduction
    Mr. Chairman, Ranking Member Filner, and Members of the Committee, 
I am AnthonyD. Watson, Director, Division of Anesthesiology, General 
Hospital, Infection Control, and Dental Devices, Office of Device 
Evaluation, Center for Devices and Radiological Health (CDRH) at the 
Food and Drug Administration (FDA or the Agency). Thank you for the 
opportunity to discuss reprocessing of reusable medical devices and the 
importance of adequate reprocessing to protect patient safety. FDA is 
committed to working with our partners in industry, government and care 
settings to ensure patients are not at risk from unacceptable lapses in 
patient safety practices related to the reprocessing of medical 
devices. Today, I will provide you with an overview of medical device 
regulation, discuss the background on reprocessed medical devices, and 
describe actions FDA is taking to address safety concerns related to 
reprocessing of reusable medical devices.
Overview of Device Regulation
    A medical device, as defined by Federal law, encompasses several 
thousand health products, from simple articles such as tongue 
depressors and heating pads to cutting-edge and complex devices such as 
implantable defibrillators and robotic equipment for minimally invasive 
surgery.
    The Medical Device Amendments of 1976 to the Federal Food, Drug, 
and Cosmetic Act (FD&C Act or the Act) gave FDA specific authority to 
regulate the safety and effectiveness of medical devices. Medical 
devices are assigned to one of three regulatory classes based on risk.
    Class I, General Controls, is the lowest risk category of devices 
and includes items such as adhesive bandages. These devices are subject 
to the General Controls of the Act, which include establishment 
registration and device listing, compliance with current Good 
Manufacturing Practice (cGMP) and labeling, recordkeeping, and 
reporting requirements.
    Class II, Special Controls, is the next category of risk and 
includes devices such as intravenous catheters and powered wheelchairs. 
They are subject to the General Controls of the Act as well as Special 
Controls, which may include special labeling requirements, mandatory 
performance standards, and post-market surveillance, in order to 
provide reasonable assurance of the safety and effectiveness of the 
device.
    Class III is the highest risk category of device and includes 
devices such as heart valves and coronary stents. These devices are 
subject to the General Controls of the Act, plus approval prior to 
marketing of a premarket approval application containing scientific 
evidence of the device's safety and effectiveness.
Adverse Event Reporting
    Once a medical device is marketed, FDA monitors reports of adverse 
events and alerts health professionals and the public when needed to 
ensure proper use of devices and the health and safety of patients. FDA 
uses two principal systems to capture device-related adverse event and 
product problem reports: the Medical Device Reporting regulation (MDR) 
and the Medical Product Safety Network (MedSun).
    MDR is the mechanism by which FDA receives over 300,000 significant 
medical device adverse events annually from manufacturers, importers, 
and user facilities, including hospitals. FDA carefully evaluates the 
reports received to identify safety concerns of public health 
importance, such as product problems that could potentially cause 
injury. User facilities are required to report deaths to the 
manufacturer and FDA and serious injuries to the manufacturer. 
Manufacturers must report to FDA within 30 days deaths, serious 
injuries, and malfunctions that could contribute to a death or serious 
injury. FDA also receives voluntary reports from many different sources 
including consumers and healthcare professionals.
    The limitations inherent in passive reporting systems such as MDR, 
include underreporting of adverse events, the submission of incomplete 
or difficult-to-understand reports, and insufficient information to 
accurately identify the product in question. Recognizing the 
limitations of passive reporting systems, FDA launched MedSun in 2002. 
MedSun is an ``active'' adverse event reporting program that allows FDA 
to work collaboratively with the clinical community to identify, 
understand, and solve problems with the use of medical devices. Over 
350 healthcare facilities, primarily hospitals, participate in the 
MedSun Network.
    Facilities participating in the MedSun Network use an Internet-
based system to report adverse medical device events to FDA. MedSun 
facility reporting differs from the other (mandatory) user facility 
reporting because MedSun participants not only report medical device 
problems that result in serious injury or death, but they also are 
encouraged to voluntarily report problems with devices, such as 
``close-calls,'' potential for harm, and other safety concerns.
    In general, FDA may become aware of device-related or associated 
adverse events that occur in hospitals through the following 
mechanisms:

    1.  the hospital submits an MDR directly to FDA (as described 
above);
    2.  a voluntary report from a clinician or patient associated with 
the hospital and/or the event;
    3.  a report to the MedSun program (if the hospital is in the 
program, as described above);
    4.  the hospital submits information regarding the event to the 
manufacturer, who then reports an MDR to FDA as part of their MDR 
reporting obligation; and
    5.  through the Centers for Disease Control and Prevention (CDC) 
when it undertakes a possible outbreak investigation at the request of 
a State health department.
Reprocessing of Reusable Medical Equipment
    Reusable medical devices are devices that are designed and labeled 
for use on multiple patients and are made of materials that can 
withstand repeated reprocessing, including manual brushing and the use 
of chemicals. Some examples of reusable medical devices are surgical 
instruments, such as clamps and forceps; endoscopes, used to visualize 
areas inside the body; and accessories to endoscopes, such as 
arthroscopic shavers; and laparoscopic surgery accessories, such as 
graspers and scissors.
    All reusable medical devices can be grouped into one of three 
categories according to the degree of risk of infection associated with 
their use:

      Critical devices, such as surgical forceps that come in 
contact with the bloodstream or normally sterile tissue.
      Semi-critical devices, such as certain endoscopes that 
come in contact with mucus membranes.
      Non-critical devices, such as stethoscopes that come in 
contact with intact skin.
Description of Reprocessing Process
    Adequate reprocessing of reusable medical devices is a critically 
important step in protecting patient safety. Reprocessing is intended 
to remove blood, tissue, and other debris and to inactivate infectious 
microbes to ensure that devices are safe for the next patient use. 
Reprocessing can be both labor-intensive and time-consuming, because 
most reusable medical devices require a specific reprocessing regimen.
    In general, reprocessing reusable medical devices involves three 
steps: initial decontamination and cleaning at the point of use; 
transfer to the reprocessing work area where the device is thoroughly 
cleaned; and, either low/intermediate disinfection, high-level 
disinfection, or sterilization, depending on the intended use of the 
device, its risk of infection transmission, and the materials from 
which it is made. The device is then stored or routed back into use.
    Many factors contribute to reprocessing difficulties, including 
device complexity, absence of best practices, user error, and poor 
instructions on how to reprocess. Manufacturers, healthcare facilities, 
healthcare professionals, and FDA share responsibility for reducing the 
risk of healthcare-associated infections (HAIs) from inadequately 
reprocessed reusable medical devices. HAIs are infections caused by a 
wide variety of common and unusual bacteria, fungi, and viruses during 
the course of receiving medical care.
FDA Authority/Role
    Under FDA labeling regulations, 21 CFR Part 801, a device must have 
adequate directions for use. This includes instructions on how to 
reprocess (i.e., clean and disinfect or sterilize) a reusable device to 
ensure that it is effectively prepared for its clinical use. FDA 
applies its unique position and expertise to reduce the risk of 
infection from reusable medical devices by evaluating devices prior to 
marketing, identifying device designs that facilitate proper 
reprocessing, assuring that manufacturer instructions are clear, and 
promoting collaboration among all stakeholders. FDA also works with 
manufacturers to correct product problems associated with reprocessed 
medical devices.
Manufacturer Role
    Manufacturers should design their devices to minimize debris 
retention, so they can be easily and effectively cleaned. Instructions 
for reprocessing, included in product labeling, should be complete, 
detailed, practical, and easy to understand. FDA expects manufacturers 
to validate their reprocessing protocols using clinically relevant 
soil, considering the internal components of the device, and using an 
actual marker(s) (a measured component of the soil, such as protein, 
inorganic carbon, etc.) for clean under-simulated use conditions and 
worst-case scenarios.
Healthcare Facility and Provider Roles
    Healthcare institutions and staff and medical personnel share 
responsibility for preventing problems associated with reprocessing. 
Facilities should periodically assess infection control practices in 
clinical areas using audit tools. Facilities should also ensure that 
those responsible for reprocessing understand the importance of the 
job, are given the necessary training to perform it properly, and 
maintain proficiency in performing reprocessing for each type of device 
they reprocess. Reprocessing staff should understand that pre-cleaning, 
cleaning, high-level disinfection, and/or sterilization are distinct 
and separate steps of reprocessing and that they should follow 
reprocessing instructions provided by device manufacturers.
    Physicians and nurses should consider that reprocessing plays a 
role in device performance and follow-up with the appropriate chain of 
accountability. They can do this by reporting adverse events that may 
be related to inadequate reprocessing, following guidelines established 
by professional societies, and communicating with manufacturers 
regarding labeling issues and ease of reprocessing.
Challenges
    Based on adverse event reports received, FDA has identified several 
safety concerns with reprocessed medical equipment. For example, in a 
review of adverse event reports on endoscopes filed with the Agency 
from January 1, 2007, to May 11, 2010, FDA identified 80 reports of 
inadequate reprocessing and 28 reports of infection that may have 
occurred from inadequate reprocessing. Endoscopes are long thin tubes 
with a camera or a light that are threaded into the lungs, the blood 
vessels, or other cavities to visualize areas within the body. The 
designs of endoscopes are intricate and complex, making optimal 
cleaning, high-level disinfection, or sterilization difficult. It is 
important to note, however, that endoscopes are used in over 10 million 
medical procedures per year. While it appears that the risk of 
acquiring such an infection is relatively low and that the benefits of 
these important devices outweigh their risks, we continue to work with 
industry, provider and government partners to further reduce risks to 
patients.
    Additional challenges to adequate reprocessing of reusable devices 
include the detailed, labor-intensive, and time-consuming nature of the 
necessary processes and the fact that each reusable medical device 
requires specific reprocessing steps or techniques appropriate for that 
device. While manufacturers are required to validate their reprocessing 
instructions by documenting that the recommended cleaning, 
disinfection, or sterilization process consistently results in an 
adequately reprocessed device, many manufacturers do not use a 
clinically relevant test soil in the validation testing of their 
cleaning instructions for use, nor do they use an adequate marker for 
the removal of soil. Finally, facility reprocessing challenges, such as 
inadequate staff training and failure to consistently follow 
reprocessing procedures, have been noted.
FDA's Work With the VA and CDC
    The VA and FDA have a Memorandum of Understanding in place which 
allows for timely information sharing to enhance knowledge and 
efficiency between the Federal partners. Within FDA, CDRH has 
designated a liaison that the VA may contact at any time regarding 
questions or concerns on any topic. With regard to reprocessing, 
beginning in 2008, the VA and FDA have collaborated to address concerns 
regarding reprocessing of reusable medical devices and cross-
contamination of endoscopes during reprocessing. The Agency has 
provided labeling and general information on FDA regulations and 
participated in the VA conference entitled ``Reprocessing of Reusable 
Medical Equipment: Using a Team Approach Towards a Strategic Plan,'' 
December 9-11, 2009.
    Further, on November 19, 2009, the VA, CDC, and FDA issued a joint 
safety communication regarding endoscope reprocessing, cautioning 
healthcare facilities, including hospitals, ambulatory care facilities, 
and private practices, about the risks to patients of improperly 
processed flexible endoscopes and their accessories and recommended 
steps to reduce these risks.
    The VA has developed and shares with FDA information from its 
national electronic Cardiovascular Assessment Reporting and Tracking 
System (CART-CL), a network of approximately 70 cardiac catheterization 
labs. FDA staff reviews this information with VA on a monthly basis, 
and triages for appropriate further actions. Ongoing communication 
benefits both parties, with FDA learning of unexpected lab-based 
experiences, and CART-CL learning about FDA recalls and public health 
communications.
    CDC and FDA communicate quite frequently on matters related to 
general infection control and to coordinate on the approval of some 
respiratory devices. FDA has an ex-officio member on CDC's Healthcare 
Infection Control Practices Advisory Committee. CDC has an official 
liaison stationed at FDA, and there are regular interagency 
teleconferences with CDC, FDA and EPA to discuss liquid chemical 
germicides, high- level disinfectants and various aspects of 
reprocessing of mutual interest to all three agencies.
Actions FDA is Taking
    Adequately reprocessing reusable medical devices is a critically 
important step in protecting patient safety. FDA is taking a 
collaborative approach toward improving the reprocessing of reusable 
medical devices. On April 29, 2011, FDA launched the Reusable Medical 
Devices Improvement Initiative to reduce the risk of HAIs from 
inadequately reprocessed medical devices. FDA's approach to addressing 
reprocessing problems focuses on collaborating with other government 
agencies, manufacturers, healthcare facilities, and healthcare 
professionals to strengthen all steps in reusable device reprocessing 
by fostering improved, innovative device designs to reduce debris 
retention, strengthening the science of cleaning and high-level 
disinfection or sterilization of medical devices, and ensuring that 
healthcare facilities properly perform cleaning, disinfecting, and 
sterilization.
    Specifically, FDA has issued revised draft guidance that updates 
and clarifies the recommended content of, and review procedures for, 
medical device applications concerning the labeling instructions for 
reprocessing reusable medical devices. In addition, this draft document 
provides more detail about FDA's recommendations for the validation of 
processes intended to support reprocessing. We have also announced a 
public meeting to be held on June 8-9, 2011, to discuss factors 
affecting the reprocessing of reusable medical devices and FDA's plans 
to address the identified issues. Finally, FDA has developed a webpage 
that provides general outreach about reprocessing of reusable medical 
devices, the challenges of reprocessing, actions FDA is taking to 
improve safety and effectiveness, and steps consumers and healthcare 
professionals can take to learn more about reprocessing reusable 
medical devices and reporting problems to FDA.
Goals of These Actions
    The Reusable Medical Devices Improvement Initiative focuses on 
improvements in device design, reprocessing procedures and protocols, 
and healthcare facility quality assurance practices. This initiative 
will promote innovation in next-generation reusable medical device 
design that will make medical devices easier to clean, disinfect, and 
sterilize, advance the science of cleaning and cleaning validation 
methods, foster healthcare facility reprocessing quality assurance 
programs, and share best practices.
    The Public Meeting will bring together key stakeholders including 
industry, user facilities, standards organizations, healthcare 
accreditation organizations, government agencies, and professional 
societies the first in a series of conversations between FDA and 
reusable medical device stakeholders.
Conclusion
    Reducing the risk of infection from reusable medical devices is a 
shared responsibility, and one that the FDA takes very seriously. By 
using its unique vantage point, FDA is helping address unacceptable 
patient safety problems with reprocessed devices while facilitating 
improvements in innovative design of the next generation of these 
devices. Mr. Chairman, this concludes my formal statement. I will be 
happy to address any questions you may have.
                   MATERIAL SUBMITTED FOR THE RECORD

                                     Committee on Veterans' Affairs
                                                    Washington, DC.
                                                       May 12, 2011

The Honorable Eric K. Shinseki
The Secretary
U.S. Department of Veterans Affairs
Washington, DC 20420

Dear Secretary Shinseki:

    In reference to our Full Committee hearing entitled ``Sacred 
Obligation: Restoring Veteran Trust and Patient Safety,'' that took 
place on May 3, 2011, I would appreciate it if you could answer the 
enclosed hearing questions by the close of business on June 24, 2011.
    In an effort to reduce printing costs, the Committee on Veterans' 
Affairs, in cooperation with the Joint Committee on Printing, is 
implementing some formatting changes for materials for all full 
Committee and Subcommittee hearings. Therefore, it would be appreciated 
if you could provide your answers consecutively and single-spaced. In 
addition, please restate the question in its entirety before the 
answer.
    Due to the delay in receiving mail, please provide your response to 
Debbie Smith by fax at 202-225-2034. If you have any questions, please 
call 202-225-9756.

            Sincerely,

                                                         BOB FILNER
                                          Ranking Democratic Member
    CW:ds

                               __________

                        The Honorable Bob Filner
                       Ranking Democratic Member
                  House Committee on Veterans' Affairs
   Hearing on Sacred Obligation: Restoring Veteran Trust and Patient 
                                 Safety
                              May 3, 2011
    Question 1: Dr. Petzel, would you agree that there is a problem 
within the Veterans Health Administration with compliance of 
established protocols, policies and procedures? If so, what are you 
doing about it?

    Response: Yes, there are challenges in ensuring 100 percent 
compliance with established policies across 152 medical centers, 798 
community based outpatient clinics, and 313,539 employees. Because this 
is such an important issue, I, as Under Secretary for Health, have 
undertaken a realignment of the Veterans Health Administration (VHA). 
Clinical elements previously focused only policy development have been 
moved into the Deputy Under Secretary for Health for Operations and 
Management (DUSHOM) Operations and Management section. This realignment 
provides clinical leaders who will: better ensure compliance with 
existing policies; improve compliance mechanisms in future policies; 
and improve accountability, with a direct link to the Veterans 
Integrated Service Network operational structure and the ability to 
directly influence practices and clinical outcomes.
    These clinical leads will develop a dashboard, or set of metrics, 
in the areas of homelessness, primary care, mental health, dental, 
surgical services, geriatrics and extended care, sterile processing 
department (SPD), disability management, and rural health operations. 
These dashboards allow the DUSHOM to better monitor the quality of care 
provided at the field level. For example, we are aggressively 
inspecting SPDs (a total of 9 per year per facility), and are 
consolidating inspection data to track policy compliance in several key 
areas. Facilities with problems identified through inspections must 
submit remediation plans that are tracked through completion by VA's 
national SPD office.
    Additionally, VHA oversight functions have been consolidated under 
the Principal Deputy Under Secretary for Health (PDUSH). This will 
serve to align and reconcile results of internal and external reviews, 
with VHA performance metrics and performance results within a single 
entity allowing for clear identification of outliers and improvements. 
Under the leadership of the PDUSH and DUSHOM, operations and management 
leaders will work closely with a new VHA Quality, Safety, and Value 
(QSV) program office to ensure policy compliance and oversight is 
improved. QSV will increase senior leader accountability for the 
quality of clinical programs as well as the quality of VHA oversight of 
those clinical programs. The Clinical Consultation and Compliance 
program within QSV is tasked with implementing an International 
Organization for Standardization (ISO) 9001-consistent Quality 
Management System (QMS) in VHA, beginning with SPD.
    ISO 9001 is the internationally recognized standard for the quality 
management of businesses. It applies to the processes that create and 
control the products and services an organization supplies. This 
approach prescribes systematic control of activities to ensure that the 
needs and expectations of customers are met. This method is designed 
and intended to apply to virtually any product or service, made by any 
process anywhere in the world. The ISO 9001 tools are widely recognized 
as a best practice approach to hardwire continuous quality improvement 
into organizational structures. I believe this approach will move VHA 
forward in reaching our shared goals for improvements in the VA 
healthcare system.

    Question 2: It is clear to me that more attention needs to be 
brought upon managers within the system who are accountable for 
ensuring that policies are in place, enforced and reinforced and that 
the management of personnel who are entrusted with carrying out the 
policies needs to be bolstered. People need to be held accountable at 
every level for not doing the right thing. When you have a Service 
Chief who does not do ANYTHING about the behavior of practicing 
dentist, even though he had been informed that infectious control 
protocols were being completely ignored, indicates to me a glaring 
weakness in leadership principles.

    Question 2(a): How can behavior such as that [of the dentist in 
question in Dayton] go unnoticed for as long as it did when multiple 
staff members knew what was going on?

    Response: This error was one of leadership--a failure on the part 
of the service chief to act in response to employee complaints. 
Inadequate leadership by the dental service chief created an atmosphere 
in the dental clinic that discouraged individual employee 
responsibility and accountability. The employees failed to go above the 
service chief to make the medical center director or others aware of 
the issue. Given the number and frequency of physical reviews and 
inspections of the dental clinic by individuals from other departments 
at the Dayton VAMC, employees from other VHA facilities, and 
organizations external to VHA, I, as Under Secretary for Health, was 
greatly disappointed to learn that the dental clinic issues were not 
reported earlier. As a side note, a large number of VHA employees are 
also veterans who receive care at their place of employment. These 
employees represent the full range of healthcare professional and 
support occupations, and are trained in VHA's expectations for 
infection control and customer service. VHA did not receive complaints 
from our non-dental service employees who received dental services.
    During the week of May 2-5, 2011 a Management Review Team conducted 
an on-site Management Program Review at the dental clinic as requested 
by the DUSHOM. This team was comprised of seasoned current and former 
VHA executives. Among many issues reviewed in detail were the length of 
time the unacceptable practices continued and the failure to correct 
those practices. The team report offered 11 recommendations for 
improvement across many program areas. These recommendations are under 
final review and action plans have been developed to implement them . 
Again, while this situation occurred primarily due to a failure of 
leadership by the former service chief, it was determined that 
improvement actions were needed in other program areas such as quality 
management, organizational development, and patient safety.

    Question 2(b): Why do you think other staff members did not come 
forward when nothing was done about the dentist's behavior?

    Response: Cultural and other environmental factors may have 
contributed to staff members not reporting. However, despite concerns 
regarding the impact of making such a complaint on their career, or 
about retaliation from the dentist in question or the former service 
chief, VHA employees have various means of reporting complaints or 
concerns. These include reporting through the Office of the Inspector 
General (OIG), Office of the Medical Inspector, or to Infection Control 
or Patient Safety. Additionally, the System-wide Ongoing Assessment and 
Review Strategy (SOARS) program, The Joint Commission, and OIG had 
visited the facility on multiple occasions before discovery of this 
unacceptable practice. Dental employees could have approached those 
individuals at any time to make them aware of these issues.
    The VHA National Center for Organizational Development (NCOD) 
offers organizational assessment and consultation services to VHA 
organizations nationwide. NCOD assists with the design, administration, 
and feedback provision of the VHA All Employee Survey. NCOD also 
maintains an active research arm focused on organizational outcomes. 
Approximately 1 year prior to discovery of the practices of the 
dentist-in-question, NCOD had been engaged by Dayton VAMC to review and 
assess outlier employee satisfaction scores identified at the dental 
clinic via the nationally administered All Employee Survey. Since the 
discovery of issues at the dental clinic, NCOD has conducted onsite 
programs in the dental clinic to help clarify organizational climate 
and environmental issues. NCOD is available to provide training, 
coaching, and other assistance to individual leaders, managers, and 
supervisors in all programs and departments at the Dayton VAMC.
    Although this report is still being reviewed, of the 
recommendations in the Management Review Team Report, three encompass 
organizational climate and development issues: specifically executive 
team building; development of soft skills across the organization; and 
executive leadership transition. NCOD will provide additional 
consultation in these areas and actions are underway to identify 
seasoned VHA leaders to provide additional coaching and consultation as 
action plans are developed to move forward to address the 
recommendations made by the review team.
    Additionally, the situation in the dental clinic has been used as a 
teachable moment in a variety of meetings with Dayton VAMC staff, in 
particular the obligation and requirement to report instances of 
improper infection control and substandard patient care, to pursue 
those reports further if action is not taken to address identified 
issues, and to identify methods such reporting can be accomplished 
either anonymously or by self identification. This was specifically 
addressed during the stand-down period held in the dental clinic, where 
the dental clinic was temporarily closed to allow for staff retraining.

    Question 2(c): Is the leadership team not accessible to the front-
line worker?

    Response: We have no evidence that any employee from the dental 
clinic ever attempted to bring their concerns to the leadership team 
and were turned away, or prevented from doing so. No member of the 
dental clinic staff interviewed stated that they had made any effort to 
contact the leadership team.
    The senior leadership team at any VA Medical Center is accessible 
to staff by several means, including scheduled committee meetings, 
special hospital wide programs and celebrations, visits to various work 
areas, and facility assessment walk throughs. In addition, all senior 
leadership team members are accessible by email, as they are included 
in the e-mail directory at each location.
    A number of reviews of the dental clinic were conducted prior to 
the discovery of practices of the dentist in question. Among these were 
semi-annual physical environmental inspections conducted by a large 
multi disciplinary team from other Dayton VAMC departments and led by 
the Associate Medical Center Director. During these environmental 
rounds, extensive discussions take place between team members and 
employees in the area undergoing inspection. These discussions take 
place simultaneously in the various work areas under review. It would 
not have been possible for the former service chief to monitor or 
control in any way all related interactions or discussions. The 
practices of the dentist in question were not identified during these 
physical inspections of the dental clinic.
    At the Dayton VAMC, suggestion boxes are placed at multiple 
locations across the Dayton campus to allow for employees, patients and 
visitors to communicate directly with the senior leadership team. This 
approach allows for anonymous participation. The former Medical Center 
Director conducted quarterly all employee town hall meetings where any 
employee had the opportunity to raise issues and/or ask him questions 
directly.
    Presently, the Acting Medical Center Director has a well-publicized 
open door policy allowing for any employee to drop by unscheduled, to 
discuss any issue. He is frequently out in the medical center on 
unannounced ``walkabouts'' to seek out and engage employees. A formal 
ambassador program has been created for senior leaders where senior 
leaders all are scheduled for well-publicized informal engagement 
sessions in the main hospital lobby and accessible to employees, 
veterans, and visitors. A new working group has been established that 
includes Veteran Service Organization (VSO) and elected officials 
representatives, to share information collaboratively and specifically 
identify stakeholder issues and concerns. Finally, the Acting Medical 
Center Director is making personal visits to individual VSO posts 
across the Dayton VAMC service area.

    Question 3: Please explain to the Committee how long the external 
peer review program has been in place and how often they look at cases 
for each facility to assess the care provided?

    Question 3(a): What, as a manager, do you do with those reports?

    Question 3(b): The Veterans Integrated Service Network Directors 
are very senior employees, how do these reports affect them?

    Response: The national external peer review contract was awarded on 
September 30, 2009 and was implemented during FY 10. The external 
reviews consist of audit reviews and facility requested peer reviews. 
The audit reviews serve to assess inter-rater reliability on peer 
reviews completed by facility staff as well as validate our local 
process. Facility requested peer reviews are conducted when there is 
not enough clinical depth in a particular specialty to obtain a peer 
review, when a senior level provider, such as a service chief, is under 
review, or when facility leadership determines an independent outside 
review is warranted.
    All VA facilities are required to submit cases once per quarter for 
audit review. The large tertiary care facilities (complexity 1a and 1b) 
submit 15 cases/quarter; the smaller facilities (complexity 1c, 2, and 
3) submit 10 cases/quarter. As of May 20, 2011, 281 facilities 
requested reviews and 1,785 audit reviews have been completed. The 
completed external peer reviews have a secondary review by clinical 
staff in the Office of Quality and Safety (OQS). Any clinical concerns 
are brought to the attention of the VISN Chief Medical Officer, VISN 
Quality Management Officer, facility Chief of Staff, and the facility 
Quality Manager or Risk Manager. Teleconference calls are scheduled 
with OQS staff, medical experts from the contractor, VISN, and medical 
staff to discuss cases when an opportunity for performance improvement 
is identified. The external peer review program is contributing to our 
ongoing mission to provide high quality care to our veteran population.

    Question 4: What qualities and skills does VHA look at when 
considering a selection for a VA Medical Center Director?

    Response: Any Medical Center Director candidate must have a broad 
and in-depth knowledge of healthcare systems. They must be able to 
analyze complex issues, identify steps to resolve problems or implement 
policy, evaluate outcomes and take corrective action where indicated. 
They must have strong leadership skills to responsibly and effectively 
triage clinical and management issues as they arise. Sound judgment is 
paramount and must foster an environment of professionalism, optimism, 
honesty, integrity, commitment to quality, continuous learning and 
candor. The candidate must have a strong sense of duty, honor and 
commitment to provide the highest quality of healthcare to those who 
have served our country. Potential candidates are required to have 
demonstrated hands-on healthcare operations experience, professional 
board certification and continuing education are used to ascertain an 
individual's commitment to maintaining and advancing one's personal 
skill set, and a proven record of significant prior accomplishments is 
required.

    Question 5: What are the actions taken with facility management and 
leadership when the VA Inspector General repeatedly finds problems at a 
facility?

    Response: VA leadership assesses each case and takes appropriate 
personnel actions when indicated. A broad range of actions may be 
considered ranging from the development of remediation plans to 
disciplinary action depending on the nature and severity of the issue. 
Issue-specific action plans may also be developed by the facility to 
address identified issues. These are approved by the VISN and the OIG 
and implementation is then monitored at the facility and VISN level.

    Question 6: Both the Inspector General and the Government 
Accountability Office have stated in separate reports that patient 
safety is at risk due to leadership failures and weaknesses in policies 
and oversight.

    Question 6(a): What are you doing to improve leadership quality and 
management training?

    Response: As stated previously, a VHA reorganization is being 
implemented at the highest levels of VHA to ensure appropriate 
resources are aligned to accomplish the improvements needed. NCOD as 
described previously, is a nationwide resource, that is actively 
engaged across the VHA system to help identify improvement 
opportunities and provides the tools and support necessary to achieve 
improvements.
    Additional actions have been taken by the National Center for 
Patient Safety (NCPS). NCPS provides patient safety training programs 
geared toward improving communication and hand-offs for facility staff 
and leadership including: Medical Team Training (MTT), and Clinical 
Crew Resource Management (CCRM). Specifically in regards to infection 
control and re-useable medical equipment, training modules and tools 
related to supply/equipment reprocessing resulting from joint work have 
been shared with facilities, Networks and VHA Central Office leadership 
and staff. These include: a series of core lessons learned from 
reprocessing investigations completed in late 2010 (Attachment A); a 
nationwide Healthcare Failure Mode and Effects Analysis (HFMEA) project 
completed in 2007 (Attachment B); and, a presentation at the national 
Network and Facility leadership meeting ``Preventing Infection is 
Everyone's Job'' in early 2011.

                               __________
        NCPS Lessons Learned--Reusable Medical Equipment in VHA
                Lori A. King, Biomedical Engineer, NCPS
    The National Center for Patient Safety (NCPS) has been involved in 
many investigations involving set-up, use, and reprocessing of reusable 
medical equipment (RME) over the last few years. We have issued Patient 
Safety Alerts and Advisories on some of these topics. The two most 
well-known VHA Patient Safety Alerts on the subject are the following:

      Patient Safety Alert AL06-11, issued on April 3, 2006, 
dealt with transrectal ultrasound transducers used for prostate 
biopsies (http://www.patientsafety.gov/alerts/B-
KMedicalTransducerAlert06-011.pdf). The facility reported soiled needle 
guides and later learned that brushes had not been used to clean the 
lumens of the needle guides. Patients from several medical centers 
required notification and follow up testing (for HIV, Hep C, and Hep 
B), resulting in the largest look back/notification in VHA's history.
      Patient Safety Alert AL09-07, issued on December 22, 
2008, discussed improper setup and reprocessing of endoscopic 
irrigation accessories (http://www.patient safety.gov/alerts/
OlympusScopesAlertAL09-07-WWW.pdf). This Alert also required patient 
notification for some facilities and prompted VHA to look at all of the 
reprocessing of RME in VHA facilities.

    With all of the additional attention provided nationally to 
reprocessing since December 2008, numerous issues with set-up, use, and 
reprocessing of RME have been reported from VHA facilities via Issue 
Briefs up through their VISN Offices to Central Office. Additional 
issues have been identified in Office of the Inspector General Combined 
Assessment Program (OIG-CAP) reports, System-wide Ongoing Assessment 
and Review Strategy (SOARS) reports, and other investigations.
    From involvement in many of these investigations we have identified 
causative factors that have contributed to the potential for risk to 
patients. The risk factors are outlined below along with suggestions 
that facilities can put in place to mitigate the risks. The risk 
factors and suggestions are listed in no particular order; all are 
important to protect our veterans from potential harm.
    By providing an environment where staff feel protected to report 
discrepancies, without fear of retribution or discipline, we encourage 
such issues to come to light and they (along with suggestions for 
mitigating the risks) can be shared nationally to ensure we are 
providing the best care for our veterans.
                              Attachment A

------------------------------------------------------------------------
                                                          Suggestion to
                      Risk Factor                         Mitigate Risk
------------------------------------------------------------------------
Reprocessing devices and device accessories in a
 manner inconsistent with manufacturer's instructions
 (i.e., not following the manufacturer's instructions
 step by step or omitting steps).

Some examples:

   Devices and device accessories not fully
 disassembled before reprocessing
                                                        Follow the
   Devices not sufficiently cleaned prior to     manufacturer's
 disinfection or sterilization (e.g., neglecting to      instructions
 brush lumens or channels; failing to fully submerge a   for
 device that requires full submersion into the           reprocessing--e
 cleaning solution)                                      xactly, step by
                                                         step.


------------------------------------------------------------------------
   Use of reprocessing agents not approved by
 the manufacturer (e.g., use of hand soap instead of
 an enzymatic cleaner; use of alcohol or sterilizing
 wipes instead of high level disinfection or
 sterilization)
                                                        Do not rely on
   Devices not high level disinfected or         verbal or
 sterilized (e.g., not using the sterilization           emailed
 parameters set forth by the manufacturer's              instructions
 instructions; cleaning but not high level               from
 disinfecting or sterilizing)                            manufacturers.
                                                         Follow official
                                                         guidance from
                                                         the
                                                         manufacturer
                                                         (e.g.,
                                                         information
                                                         obtained from
                                                         the
                                                         Instructions
                                                         for Use,
                                                         Reprocessing
                                                         Guides, Company
                                                         Brochures,
                                                         Memorandum on
                                                         company letter
                                                         head, etc.).







------------------------------------------------------------------------

Manufacturer's set up and/or use instructions not
 followed

Some examples:

   Not priming endoscope irrigation systems
 prior to insertion into patient

   Staff ``rigging'' or ``making do'' with
 defective devices or devices missing parts such that
 procedures don't get canceled
                                                        Follow the
   Multiple patient use of single use devices    manufacturer's
                                                         instructions
                                                         for set-up and
                                                         use--exactly,
                                                         step by step.




------------------------------------------------------------------------
                                                        Purchase devices
                                                         and systems
                                                         with built-in
                                                         fault
                                                         tolerance,
                                                         where possible,
                                                         making it
                                                         harder for
                                                         users to make
                                                         mistakes in set
                                                         up or
                                                         operation.


------------------------------------------------------------------------

Inappropriately trained staff                           Ensure that
                                                         there are an
                                                         adequate number
                                                         of trained
                                                         staff and
                                                         supervisors at
                                                         all times in
                                                         SPD to meet
                                                         their mission
                                                         and
                                                         responsibilitie
                                                         s.





------------------------------------------------------------------------

Use of reusable devices that are difficult to clean     Where possible,
 properly, by design, even when the manufacturer's       purchase and
 instructions are followed (e.g., certain graspers,      use disposable
 Kerrison Rongeurs, suction tips, dental burrs)          or ``take apart
                                                         devices'' for
                                                         hard to
                                                         reprocess
                                                         items.

------------------------------------------------------------------------

Staff not wanting to surrender instruments to SPD for   Have the
 reprocessing for fear of loss or damage to devices      department work
                                                         closely with
                                                         SPD and ensure
                                                         SPD staff is
                                                         properly
                                                         trained to
                                                         handle and
                                                         reprocess the
                                                         department's
                                                         delicate
                                                         devices.

------------------------------------------------------------------------

Not reprocessing a reusable device according to the     Reprocess the
 original equipment manufacturer's instructions once a   device
 protective sheath has been removed (e.g., removing      according to
 the sheath and then using sterilizing wipes followed    the original
 by application of another sheath)                       equipment
                                                         manufacturer's
                                                         instructions
                                                         after each use--
                                                         even if a
                                                         protective
                                                         sheath was used
                                                         on the device
                                                         during the
                                                         procedure.

------------------------------------------------------------------------

Unclear terminology and/or lack of clear reprocessing   Don't make
 instructions from the manufacturer and subsequent       assumptions if
 assumptions made by staff                               a
                                                         manufacturer's
                                                         instructions
                                                         are unclear or
                                                         non-existent.
                                                         Get
                                                         clarification
                                                         in writing (in
                                                         a manner more
                                                         official than
                                                         email) from the
                                                         supplier. If
                                                         this proves
                                                         impossible,
                                                         contact the
                                                         National SPD
                                                         Office at 513-
                                                         487-6030.

------------------------------------------------------------------------
Lack of communication/acceptable hand off between       Ensure staff
 staff in SPD (and other areas reprocessing RME) and     communicate
 subsequent assumptions made (e.g., a staff member       what step they
 hands off the process to another staff member,          are at in the
 without indicating where they are in the process)       reprocessing
                                                         process when
                                                         they hand off
                                                         the process to
                                                         another staff
                                                         member. If the
                                                         staff member
                                                         receiving the
                                                         hand off is
                                                         unsure of any
                                                         details after
                                                         the hand off,
                                                         they should err
                                                         on the side of
                                                         caution (i.e.,
                                                         assume that
                                                         nothing has
                                                         been done on
                                                         the device and
                                                         start from the
                                                         beginning).
------------------------------------------------------------------------
Use of inappropriate storage containers for dirty       Use appropriate
 devices (e.g., using sterilization bags to store and    storage
 transport dirty items) and use of inappropriate         containers for
 storage containers for reprocessed devices (e.g.,       dirty and clean
 using reprocessing cassettes, use of foam-backed        devices.
 transport containers)


------------------------------------------------------------------------
Reprocessing occurring in peripheral locations (e.g.,   Consolidate
 Dental, Eye Clinic, GI, Urology, Radiology, etc) and    reprocessing to
 oversight staff not knowing that reprocessing was       SPD if at all
 going on in the peripheral areas                        possible. If
                                                         not possible,
                                                         include audits
                                                         of all areas
                                                         outside of SPD
                                                         (e.g., Dental,
                                                         GI, Eye Clinic,
                                                         GI, Urology,
                                                         Radiology,
                                                         etc).

------------------------------------------------------------------------
Not being cognizant of different reprocessing steps     Finding
 done on the same device used in different areas of      different
 the facility (e.g., laryngoscope blades sterilized      reprocessing
 for the OR but high level disinfected for other areas   processes
 of the facility--when the manufacturer instructions     existing with
 indicate to sterilize)                                  the same model
                                                         of device
                                                         should raise a
                                                         red flag to be
                                                         investigated.
                                                         Note however
                                                         that sometimes
                                                         it is perfectly
                                                         acceptable that
                                                         the same device
                                                         can be
                                                         reprocessed
                                                         differently
                                                         depending on
                                                         area used in
                                                         the facility--
                                                         that is,
                                                         provided the
                                                         manufacturer's
                                                         instructions
                                                         indicate it can
                                                         be reprocessed
                                                         in these
                                                         manners and the
                                                         areas where the
                                                         devices will be
                                                         used can accept
                                                         the level of
                                                         reprocessing.

------------------------------------------------------------------------
Human factors/systems issues with devices and 
 automatic reprocessors

Some examples:   Not using the appropriate automatic
 reprocessor
                                                        Ensure staff has
   Not using appropriate connections with the    been properly
 automated reprocessor                                   trained on the
                                                         use and
                                                         function of any
                                                         automatic
                                                         reprocessor
                                                         they use. ------------------------------------------------------------------------
Staff not following facility policy/protocol or lack
 of policy/protocolSome examples:   Use of equipment prior to having the
 approval to use it   Physician bringing in his/her own device
 (e.g., intubation device) and reprocessing it (often
 inappropriately)   Damaged scope (to be sent for repair) used
 on patient   Loaner instruments cleaned but not
 sterilized
                                                        Put in place the
   Loaner instruments not being reprocessed      proper policies/
 prior to use (e.g., delivered from the vendor to the    protocols to
 OR instead of SPD)                                      ensure the
                                                         examples shown
                                                         to the left
                                                         will not occur
                                                         at your
                                                         facility. ------------------------------------------------------------------------


    A special thanks to the staff at VHA facilities and VISNs, as this 
document would not be possible without their commitment to patient 
safety and their diligence in discovering issues and bringing them to 
light. Special thanks also to Sherri Bull and Rosie Fardo from the 
National SPD Office for their thorough review of this document.

                               __________

                              Attachment B
      2007 Healthcare Failure Mode and Effect Analysis (HFMEA) on
            Supply Processing and Distribution (SPD) Topics

Topics/Processes

     1.  The process of reprocessing a flexible cystoscope between 
patients including transportation, decontamination, high level 
disinfection, sterilization and storage.
     2.  The process of reprocessing a flexible colonscope between 
patients including transportation, decontamination, high level 
disinfection, sterilization and storage.
     3.  The process of reprocessing a flexible bronchoscope between 
patients including transportation, decontamination, high level 
disinfection, sterilization and storage.
     4.  The process of reprocessing a flexible 
esophagogastroduodenoscope (EGD) between patients including 
transportation, decontamination, high level disinfection, sterilization 
and storage.
     5.  The process of reprocessing a rigid endoscope used in urology 
between patients including transportation, decontamination, high level 
disinfection, sterilization and storage.
     6.  The process of reprocessing a rigid endoscope used in ENT 
between patients including transportation, decontamination, high level 
disinfection, sterilization and storage.
     7.  The process of reprocessing reusable items used to perform a 
transrectal prostate biopsy between patients including transportation, 
decontamination, high level disinfection, sterilization and storage.
     8.  The process of assuring sterility of orthopedic implantable 
devices that come in orthopedic loaner instrument trays.
     9.  The process of communicating positive biological test results 
from steam, EtO, and plasma sterilizers to the Chief of Staff, Chief of 
Surgical Service, Operating Room Supervisor and Infection Control.
    10.  The process of disinfecting an infusion pump after patient use 
including transportation and storage.
    11.  The process of using a pre-vacuum steam sterilizer in SPD 
including verifying testing (e.g. Bowie-Dick, biological), reviewing 
printouts (to determine sterilization parameters were met, signature of 
reviewer, content list (detailed enough to enable item[s] retrieval if 
necessary) and documentation of all required aspects of sterilization 
process.
    12.  The process of using the ethylene oxide (EtO) sterilizer 
within SPD including verifying testing (biological), reviewing 
printouts (parameters were met, content list, list of items), content 
list (detailed enough to enable item(s) retrieval if necessary) and 
documenting the results.
    13.  The process of using the plasma sterilizer within SPD 
including verifying biological testing, reviewing printouts (to 
determine sterilization parameters were met, signature of reviewer), 
content list (detailed enough to enable item(s) retrieval, if 
necessary) and documentation of all required aspects of the 
sterilization process.
    14.  The process of using steam sterilization in Dental including 
verifying biological testing (Bowie-Dick type test if using a pre-
vacuum sterilizer), reviewing printouts (to determine if sterilization 
parameters were met, signature of reviewer), content list (detailed 
enough to enable item(s) retrieval, if necessary), and documentation of 
all required aspects of the sterilization process.
    15.  The process of decontaminating surgical instruments prior to 
sterilization.
    16.  The process of preparing surgical instruments for 
sterilization including preparing the surgical instrument trays (e.g. 
inspecting for bioburden, checking for instrument usability, correct 
instruments in correct trays) and packaging instruments.
    17.  The process of coordinating and communicating the availability 
of needed equipment and supplies between the OR and SPD.
    18.  The process of maintaining the primary storage environment 
including: monitoring room temperature, humidity, the number of air 
exchanges per hour, pest control; maintaining the storage arrangement 
(e.g. stock rotation, avoiding outdates); and maintaining cleanliness 
for sterilized instrumentation, equipment and supplies in SPD.
    19.  The process of maintaining the secondary storage environment 
in the operating room including: monitoring room temperature, humidity, 
the number of air exchanges; pest control; storage arrangement, and 
cleanliness for sterilized instrumentation, equipment and supplies.
    20.  The processes of using sterilizers for flash sterilization in 
the operating room including monitoring the frequency of use, 
biological testing, identification of the date and patient and the 
item(s) flash sterilized, and reviewing printouts to verify 
sterilization parameters are being met.

Topic 1

The process of reprocessing a flexible cystoscope between patients 
including transportation, decontamination, high level disinfection, 
sterilization and storage.

Number of reporting facilities: 8

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Untrained Personnel                                      Provide
   Scope not cleaned properly                    all staff with
   Scope not cleaned as per manufacturer's       a thorough
 instructions                                            education
   Lack of standardized staff training           Impleme
                                                         nt a mentoring
                                                         program that
                                                         matches new
                                                         employees with
                                                         seasoned
                                                         employees
                                                         Provide
                                                         specific
                                                         training on
                                                         procedures that
                                                         are more
                                                         difficult to
                                                         perform or
                                                         remember
                                                         Provide
                                                         cognitive aids
                                                         to reduce the
                                                         amount of
                                                         information
                                                         that SPD staff
                                                         must recall
                                                         from memory
                                                         Provide
                                                         training on
                                                         manufacturer's
                                                         procedure for
                                                         cleaning
                                                         Repeat
                                                         training
                                                         annually as
                                                         necessary
------------------------------------------------------------------------
Scope not placed in distinguishable container for        Place
 transport                                               distinguishable
   May result in damage to the scope             containers in
   Red containers not easily accessible          easy access
   Difficult to find                             areas and areas
                                                         where they are
                                                         used often------------------------------------------------------------------------Unable to notify SPD or bring scope to SPD when needed   Designa
   SPD not available                             te other staff
   Off hours                                     to transport as
   Not enough staff                              per policy for
                                                         off hours scope
                                                         use 
------------------------------------------------------------------------Frequent use of brush tends to damage bristles           Use
   Result in bioburden build up                  single use
   Single use brushes used more than once        brushes once
                                                         and throw away
                                                         when done ------------------------------------------------------------------------Personal Protective Equipment (PPE) is not donned for    Place
 cleaning procedure                                      PPE in easy to
   PPE is not available                          access  ------------------------------------------------------------------------Scopes dry in a horizontal position that causes          Purchas
 pooling                                                 e a drying
                                                         cabinet with a
                                                         fan within
                                                         which scopes
                                                         can be hung
                                                         vertically 
------------------------------------------------------------------------Proper protocol not followed due to lack of adequate     Purchas
 equipment                                               e more
   Not enough equipment                          equipment
   Not the right equipment (e.g. wrong sized
 brush can cause damage to the scope) 
------------------------------------------------------------------------Scopes are not being processed at the highest level of   Purchas
 sterilization because there are not enough scopes to    e more scopes
 meet the caseload of the clinic                         to allow proper
                                                         sterilization
                                                         between
                                                         patients------------------------------------------------------------------------Using different sized sinks or wash basins can alter     Limit
 the cleaner to water ratio                              process to use
                                                         of a standard
                                                         basin only.
                                                         Ensure all
                                                         staff use the
                                                         correct basin------------------------------------------------------------------------


Topic 2

The process of reprocessing a flexible colonscope between patients 
including transportation, decontamination, high level disinfection, 
sterilization and storage.

Number of reporting facilities: 8

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Failure to disassemble endoscope before cleaning         Use the
                                                         endoscope
                                                         manufacturer
                                                         provided
                                                         cognitive aids
                                                         showing the
                                                         cleaning
                                                         process will be
                                                         posted where
                                                         clearly visible
                                                         during the
                                                         cleaning of the
                                                         endoscope
                                                         If none
                                                         are available,
                                                         construct
                                                         cognitive aids
                                                         to provide to
                                                         staff
------------------------------------------------------------------------
Surgical residents performing endoscopic procedures      Use
 after hours and on weekends do not wipe down the        signage to
 scope with a detergent soaked sponge/cloth              remind
 immediately post procedure                              residents of
                                                         post-
                                                         operational
                                                         cleaning
                                                         Annual
                                                         staff education
                                                         on proper
                                                         maintenance
                                                         Purchas
                                                         e a cleaning
                                                         kit to be kept
                                                         bedside for the
                                                         surgeon to do
                                                         initial
                                                         cleaning of the
                                                         endoscope
                                                         Develop
                                                         a checklist/
                                                         instruction for
                                                         the immediate
                                                         pre and post
                                                         procedure care
                                                         of the
                                                         endoscope and
                                                         associated
                                                         equipment and
                                                         post it in the
                                                         appropriate
                                                         areas
------------------------------------------------------------------------
Personal Protective Equipment (PPE) not used regularly   Provide
                                                         PPE in
                                                         locations near
                                                         where
                                                         reprocessing
                                                         takes place
                                                         Use
                                                         signage to
                                                         indicate where
                                                         and when to use
                                                         PPE
                                                         Be sure
                                                         to educate
                                                         staff on proper
                                                         use of PPE
------------------------------------------------------------------------
Endoscope does not dry properly, water pools in the      Provide
 endoscope                                               a storage
   Clean endoscope cabinet located in same       cabinet that
 area as contaminated endoscopes                         has adequate
                                                         ventilation and
                                                         is equipped to
                                                         store the
                                                         endoscopes
                                                         vertically
                                                         Flush
                                                         lumens with
                                                         alcohol and/or
                                                         air prior to
                                                         storage to
                                                         promote drying
                                                         Move
                                                         clean endoscope
                                                         cabinet to an
                                                         area without
                                                         contaminated
                                                         endoscopes
------------------------------------------------------------------------
Steps skipped when going through procedures of           Post
 cleaning and disinfecting (i.e. forgetting to flush     signage of
 lumens with alcohol)                                    steps for
                                                         cleaning to jog
                                                         memory
                                                         Set up
                                                         room to promote
                                                         the proper
                                                         cleaning and
                                                         disinfecting
                                                         procedures
------------------------------------------------------------------------
Appropriate containers not used to transport             See
 contaminated endoscopes                                 topic 4
   Choose not to use container because it is     ``Transportatio
 only a short distance to decontamination area           n''
   Appropriate containers not available (i.e.    Post
 only open top containers available)                     signage
                                                         indicating that
                                                         contaminated
                                                         endoscopes must
                                                         always be
                                                         transported in
                                                         a closed top
                                                         container
                                                         Provide
                                                         more
                                                         appropriate
                                                         (i.e. closed
                                                         top) containers
                                                         for transport
                                                         of contaminated
                                                         endoscopes
                                                         Be sure
                                                         to place an
                                                         adequate amount
                                                         of the
                                                         containers in
                                                         areas they are
                                                         needed
------------------------------------------------------------------------
Water temperature not adequate for activating            Install
 enzymatic solution                                      thermometers to
                                                         verify water
                                                         temperature
                                                         before using
                                                         the enzymatic
                                                         solution
------------------------------------------------------------------------
Not using adequate amount of solution when flushing      Purchas
 lumens with alcohol or other cleaning steps             e measuring
                                                         containers that
                                                         will measure
                                                         and/or dispense
                                                         the exact
                                                         amount of
                                                         solution needed
                                                         when flushing
                                                         lumens or
                                                         otherwise
                                                         cleaning the
                                                         endoscopes------------------------------------------------------------------------Timing is not adequate for steps in the reprocessing     Purchas
 of endoscopes (i.e. soak time)                          e and install a
                                                         timer in the
                                                         appropriate
                                                         areas to use
                                                         when timing
                                                         reprocessing
                                                         steps 
------------------------------------------------------------------------Endoscope not picked up from Operating Room (OR) in a    Provide
 timely manner                                           SPD staff with
                                                         a means of
                                                         communication
                                                         (i.e. pagers)------------------------------------------------------------------------Results for each scope are not traceable to specific     Staff
 patients on whom a procedure was performed              will record the
                                                         scope number in
                                                         the procedure
                                                         log
                                                         Create
                                                         a column in the
                                                         procedure log
                                                         that is used to
                                                         record the
                                                         endoscope
                                                         number for each
                                                         procedure on
                                                         each patient
                                                         Impleme
                                                         nt a barcode
                                                         system, coding
                                                         both the
                                                         patient's
                                                         wristband and
                                                         the endoscope------------------------------------------------------------------------Scopes which fail leak test may be reprocessed and       Add to
 used again on a patient                                 the procedure
                                                         the process to
                                                         follow if a
                                                         leak test fails
                                                         All
                                                         scopes which
                                                         fail the leak
                                                         test either
                                                         before or after
                                                         the procedure
                                                         should have a
                                                         work order
                                                         placed and be
                                                         taken out of
                                                         service until
                                                         repaired------------------------------------------------------------------------Patient specific tracking not done                       Develop
                                                         and implement
                                                         patient
                                                         specific
                                                         tracking log
                                                         for all scopes------------------------------------------------------------------------


Topic 3

The process of reprocessing a flexible bronchoscope between patients 
including transportation, decontamination, high level disinfection, 
sterilization and storage.

Number of reporting facilities: 10

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------Transportation                                           Set up
   Lack of appropriate space to separate clean   separate rooms
 from dirty instruments/equipment                        for dirty and
   Adequate container not available for          clean
 transport                                               instruments/
                                                         equipment
                                                         Set up
                                                         the dirty room
                                                         so that it is a
                                                         negative air
                                                         flow room with
                                                         monitor checked
                                                         daily
                                                         See
                                                         Topic 4
                                                         ``Transportatio
                                                         n''
                                                         Provide
                                                         an appropriate
                                                         transport
                                                         container that
                                                         is rigid and
                                                         properly
                                                         labeled (i.e.
                                                         biohazard)------------------------------------------------------------------------
Decontamination                                          Post
   Not performed correctly                       the cleaning
   Lack of training                              checklist, use
   Process not standardized                      as a cognitive
                                                         aid
                                                         Make
                                                         employees
                                                         accountable by
                                                         including the
                                                         employee's
                                                         identification
                                                         tag to
                                                         determine who
                                                         processed the
                                                         instruments
                                                         Maintai
                                                         n record log to
                                                         reflect serial
                                                         number of each
                                                         scope
                                                         reprocessed and
                                                         name of the
                                                         staff doing the
                                                         procedure
                                                         Require
                                                         annual training
                                                         for all staff
                                                         Develop
                                                         SOP for all
                                                         processes and
                                                         educate staff
------------------------------------------------------------------------
Cannot properly complete procedure because of lack of    Purchas
 supplies                                                e adequate
                                                         supplies
                                                         Create
                                                         and utilize a
                                                         system to
                                                         report and
                                                         purchase needed
                                                         items
                                                         Bar
                                                         code area for
                                                         items needed------------------------------------------------------------------------
Staff unaware of correct brush to use to remove          Purchas
 bioburden                                               e only
                                                         disposable
                                                         brushes
                                                         Educate
                                                         staff on which
                                                         brushes to use
                                                         to adequately
                                                         remove
                                                         bioburden
------------------------------------------------------------------------
Staff too busy to properly perform process               Re-
                                                         write position
                                                         descriptions to
                                                         adequately
                                                         reflect the
                                                         need of the
                                                         hospital and
                                                         fill all vacant
                                                         positions
------------------------------------------------------------------------
Lack of appropriate pre-cleaning/Decontamination room    Provide
 and potential for contamination                         appropriate
                                                         space to
                                                         separate clean
                                                         from dirty
                                                         instruments/
                                                         equipment that
                                                         meets VA
                                                         directive 7176
                                                         requirements
                                                         Provide
                                                         a technician to
                                                         perform all
                                                         decontamination
                                                         procedures
------------------------------------------------------------------------
Disinfection of bronchoscope is performed in various     Designa
 areas making it difficult to monitor and ensure         te one area
 compliance with proper procedure                        where the whole
                                                         process of
                                                         disinfecting
                                                         the
                                                         bronchoscope
                                                         occurs
                                                         Require
                                                         disinfection of
                                                         brochoscopes to
                                                         occur in SPD------------------------------------------------------------------------
Proper concentration of enzymatic solution not used      Place a
                                                         waterproof
                                                         label in the
                                                         sink to
                                                         indicate water
                                                         level needed
                                                         Purchas
                                                         e a container
                                                         that will
                                                         dispense the
                                                         amount of
                                                         enzymatic
                                                         solution needed
                                                         for that amount
                                                         of water (pump
                                                         bottle)
                                                         Or
                                                         purchase a
                                                         measuring
                                                         device for
                                                         obtaining the
                                                         correct amount
                                                         of enzymatic
                                                         solution
                                                         (measuring cup/
                                                         scoop)
------------------------------------------------------------------------
Improper sterilization                                   Develop
                                                         a checklist
                                                         using
                                                         manufacturer's
                                                         recommendations
                                                         Direct
                                                         observation by
                                                         supervisor to
                                                         assure
                                                         compliance with
                                                         manufacturer's
                                                         checklist
------------------------------------------------------------------------
Scope not aspirated with alcohol, substituted with       Educate
 another solution                                        staff on
                                                         alcohol use
                                                         Impleme
                                                         nt an initialed
                                                         log to identify
                                                         scope and
                                                         process steps------------------------------------------------------------------------Inappropriate storage                                    Provide
   Clean scopes left lying flat in clean         separate areas
 containers in dirty areas                               to accommodate
                                                         patient
                                                         procedure
                                                         decontamination
                                                         and storage of
                                                         instruments and
                                                         equipment in a
                                                         cabinet
                                                         Change
                                                         the procedure
                                                         to ensure that
                                                         scopes are hung
                                                         to dry after
                                                         reprocessing------------------------------------------------------------------------Failure to link scope and patient to processing cycle    Use a
                                                         bar coding
                                                         system
                                                         Develop
                                                         a system that
                                                         tracks trays
                                                         and scopes to
                                                         patient and
                                                         process used
                                                         Number
                                                         the scopes and
                                                         keep a log that
                                                         links scope
                                                         number to
                                                         patient and
                                                         process------------------------------------------------------------------------


Topic 4

The process of reprocessing a flexible esophagogastroduodenoscope (EGD) 
between patients including transportation, decontamination, high level 
disinfection, sterilization and storage.

Number of reporting facilities: 6

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Transportation                                          Develop a system
   Uncertain which bin to use                    using different
   Potential for mixing the rinsed soiled        colored bins to
 scope with the clean scope                              differentiate
   Potential for wrong container to transport    dirty and clean
 from manual cleaner to Steris                           scopes
   Potential for using wrong bin for delivery    Purchas
 of scope to end user                                    e different
     Scope could be transported incorrectly      colored bins,
 (e.g. on its knobs, coiled, twisted or double           example:
 stacked)                                                  Red
                                                         bins: Biohazard
                                                         and dirty
                                                         scopes
                                                           White
                                                         bins: Transport
                                                         from manual
                                                         cleaning to
                                                         Steris
                                                           Gray
                                                         bins: Clean
                                                         scope delivery
                                                         to end user
                                                         Educate
                                                         staff on the
                                                         need for proper
                                                         transportation
                                                         of these scopes
                                                         and the need to
                                                         transport all
                                                         equipment
                                                         correctly------------------------------------------------------------------------
Improper decontamination                                 Have
                                                         reprocessing
                                                         manual
                                                         available for
                                                         GI and SPD
                                                         staff for
                                                         immediate
                                                         reference
                                                         during
                                                         reprocessing------------------------------------------------------------------------
Potential for using the wrong sized brush or not         Keep an
 having the appropriate brushes available                ample supply of
                                                         appropriately
                                                         sized,
                                                         disposable
                                                         brushes------------------------------------------------------------------------
Potential for attaching the wrong cover to the           Impleme
 channels (i.e. different type of scope or different     nt plastic
 manufacturer)                                           identifier card
                                                         using sturdy
                                                         chains
                                                         installed to
                                                         each connector
                                                         that identifies
                                                         type of scope
                                                         and
                                                         manufacturer
                                                         Impleme
                                                         nt bar coding
                                                         system if
                                                         possible------------------------------------------------------------------------
Scope is not wiped down immediately following            Develop
 procedure                                               procedure for
                                                         nursing
                                                         supervisor and
                                                         ICU staff on
                                                         pre-cleaning
                                                         and handling
                                                         scopes
                                                         immediately
                                                         after a
                                                         procedure------------------------------------------------------------------------
Dried bioburden is not removed                           Compete
                                                         ncy for GI
                                                         nurses will
                                                         include details
                                                         on aspirating
                                                         detergent and
                                                         flushing air
                                                         through channel
                                                         Ensure
                                                         appropriate
                                                         brushes are
                                                         available for
                                                         removing
                                                         bioburden
                                                         Post
                                                         instructions as
                                                         to proper
                                                         removal of
                                                         bioburden
                                                         emphasizing
                                                         proper
                                                         technique------------------------------------------------------------------------
Failure to accomplish leak testing                       Monitor
   Failure to deflect distal tip to check for    number of wet
 leakage                                                 tests related
                                                         to number of
                                                         scope
                                                         procedures
                                                         completed
                                                         Post a
                                                         detailed
                                                         sequence of
                                                         steps in view
                                                         of key staff
                                                         assigned to
                                                         reprocessing of
                                                         scopes with
                                                         demonstrated
                                                         competency
                                                         assessed
                                                         annually and as
                                                         changes occur
                                                         Monitor
                                                         number of tip
                                                         deflections
                                                         performed
                                                         related to
                                                         number of scope
                                                         procedures
                                                         performed------------------------------------------------------------------------
High level disinfection                                  Write
                                                         SOP to provide
                                                         a standard of
                                                         practice on
                                                         processing
                                                         scopes using
                                                         high level
                                                         disinfection to
                                                         clean scopes on
                                                         clinical days
                                                         SOP
                                                         needs to be in
                                                         place to
                                                         provide
                                                         communication
                                                         with end users
                                                         on processing
                                                         of scopes to
                                                         use during high
                                                         level
                                                         disinfection------------------------------------------------------------------------
Biological results are positive, but are not             Alter
 communicated as such                                    the process to
                                                         include running
                                                         biological
                                                         indicator at
                                                         the end of the
                                                         shift
                                                         Results
                                                         will be
                                                         available to
                                                         ensure next
                                                         morning's
                                                         workload begins
                                                         with an
                                                         operational
                                                         unit
                                                         Develop
                                                         means of
                                                         communicating
                                                         test status
                                                         between
                                                         microbiology
                                                         and endoscopy------------------------------------------------------------------------
Staff may not be aware to test the Steris system each    Quality
 day                                                     control book
                                                         should be
                                                         maintained to
                                                         ensure each
                                                         Steris machine
                                                         is checked for
                                                         diagnostics and
                                                         biologicals
                                                         daily during
                                                         regular tours
                                                         Educate
                                                         staff and post
                                                         signage near
                                                         the Steris
                                                         indicating
                                                         daily
                                                         procedures------------------------------------------------------------------------
All staff may not be aware of the minute details that    Assign
 should be completed for each cleaning of scopes         key staff to
                                                         endoscope
                                                         cleaning
                                                         trained with a
                                                         detailed step
                                                         by step
                                                         process,
                                                         annually or as
                                                         changes occur
                                                         Create
                                                         a specialty
                                                         team for the
                                                         scope cleaning
                                                         process
------------------------------------------------------------------------
Storage                                                  Provide
                                                         a cabinet that
                                                         will allow
                                                         scopes to hang
                                                         to promote
                                                         proper drying
------------------------------------------------------------------------


Topic 5

The process of reprocessing a rigid endoscope used in urology between 
patients including transportation, decontamination, high level 
disinfection, sterilization and storage.

Number of reporting facilities: 8

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Transportation                                           Purchas
   Containers used for storage and               e and implement
 sterilization do not protect the scopes during          appropriate
 transportation                                          containers to
   Sterile instruments are transported on a      protect the
 dirty wire cart                                         scopes during
   Scope transported without a solid lid         transportation  
------------------------------------------------------------------------Variation in the concentration of the enzymatic          Purchas
 cleaner                                                 e a measuring
                                                         device to
                                                         select the
                                                         correct amount
                                                         of enzymatic
                                                         solution ------------------------------------------------------------------------Brushes being re-used                                    Deconta
                                                         minate the
                                                         brushes daily ------------------------------------------------------------------------Scopes arrive at SPD with dried debris on them           Impleme
                                                         nt use of
                                                         enzymatic
                                                         cleaner in a
                                                         spray bottle to
                                                         spray scopes
                                                         with after
                                                         procedures to
                                                         prevent dried
                                                         debris 
------------------------------------------------------------------------Staff unaware that ultrasonic cleaner needs to be        Place
 changed often and needs enzymatic solution              signage above
                                                         the ultrasonic
                                                         cleaner
                                                         regarding the
                                                         use of the
                                                         enzymatic
                                                         cleaning
                                                         solution and
                                                         the amount to
                                                         be used ------------------------------------------------------------------------
Variation in the scope cleaning process by SPD staff     Standar
                                                         dize the
                                                         process by
                                                         implementing a
                                                         SOP
                                                         Educate
                                                         staff in SOP
                                                         Install
                                                         cognitive aids
                                                         indicating
                                                         appropriate
                                                         steps to take
                                                         during process
                                                         of cleaning
                                                         Be sure
                                                         to purchase
                                                         adequate
                                                         numbers of
                                                         scopes to allow
                                                         reprocessing in
                                                         SPD between
                                                         uses
                                                         Purchas
                                                         e adequate
                                                         amounts of
                                                         cleaning
                                                         supplies to
                                                         allow
                                                         appropriate
                                                         reprocessing
                                                         procedures
                                                         Create
                                                         a system such
                                                         as bar coding
                                                         to track the
                                                         scope to the
                                                         person who
                                                         cleaned it
------------------------------------------------------------------------
Washer/Disinfector machine's dry cycle does not dry      Ensure
 instruments                                             that the
                                                         biomedical
                                                         engineer's
                                                         periodic
                                                         maintenance
                                                         includes drying
                                                         cycle checks
                                                         Ensure
                                                         SPD staff know
                                                         how to report
                                                         malfunctions
                                                         Add
                                                         malfunction
                                                         reports to
                                                         annual staff
                                                         training and
                                                         new employee
                                                         orientation
------------------------------------------------------------------------
Variations in scope cleaning process by SPD staff        Establi
                                                         sh SOP and
                                                         include it in
                                                         new employee
                                                         orientation,
                                                         and annual
                                                         staff training
------------------------------------------------------------------------
Storage                                                  Store
   Inadvertently placed soiled items on the      all sterile
 top of the cart where clean items are being stored      supplies in a
   There are environmental hazards such as       sterile supply
 cleaning materials or dust in the storage area          room only
                                                         Evaluat
                                                         e for the
                                                         availability of
                                                         storage space
                                                         for clean items
                                                         in the OR rooms
                                                         so clean items
                                                         are not stored
                                                         on the top of
                                                         the case cart
                                                         during
                                                         procedures
                                                         Purchas
                                                         e closed
                                                         shelving units
                                                         for quarantined
                                                         items
                                                         Relocat
                                                         e current
                                                         shelving to
                                                         minimize the
                                                         contamination
                                                         of packages due
                                                         to
                                                         environmental
                                                         hazard
------------------------------------------------------------------------


Topic 6

The process of reprocessing a rigid endoscope used in ENT between 
patients including transportation, decontamination, high level 
disinfection, sterilization and storage.

Number of reporting facilities: 2

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Transportation                                           Obtain
   While transporting the scope to be cleaned,   larger
 it is broken                                            containers to
   Endoscope may not be used in an area where    transport
 biohazard bags are present, resulting in endoscopes     scopes out of
 not placed in biohazard bags                            room to the
                                                         area where they
                                                         are processed
                                                         Provide
                                                         biohazard bags
                                                         inside
                                                         transport case
                                                         to cover
                                                         contaminated
                                                         endoscope from
                                                         inpatient units
                                                         after use
                                                         Post in
                                                         the exam rooms
                                                         and outside of
                                                         the endoscope
                                                         transportation
                                                         case, signage
                                                         indicating that
                                                         used endoscopes
                                                         must be placed
                                                         in biohazard
                                                         bags
------------------------------------------------------------------------
Timing for disinfecting and cleaning steps is not        Purchas
 consistent                                              e and install a
                                                         clock with a
                                                         second hand in
                                                         the work room
                                                         Purchas
                                                         e timers to
                                                         time endoscope
                                                         exposure to
                                                         enzymatic
                                                         detergent and
                                                         Cidex OPA
------------------------------------------------------------------------
Crucial steps in the cleaning process are omitted or     Sterile
 incomplete                                              processing of
                                                         endoscopes
                                                         should be done
                                                         by SPD staff
                                                         who have
                                                         completed
                                                         required
                                                         training and
                                                         certification
                                                         as per VHA
                                                         directive 7176
                                                         Ensure
                                                         manual is
                                                         updated and
                                                         available
                                                         Provide
                                                         in-service by
                                                         vendor to all
                                                         who are
                                                         responsible for
                                                         cleaning the
                                                         endoscopes
                                                         Due to
                                                         tedious
                                                         process, rotate
                                                         SPD staff
                                                         through
                                                         different
                                                         duties during
                                                         the day
                                                         Impleme
                                                         nt a system for
                                                         accountability
                                                         using
                                                         identifying
                                                         tags, or a bar
                                                         coding system
------------------------------------------------------------------------
Personnel without validated VAMC competency initiate     ENT
 the high level disinfection process                     clinic staff,
                                                         ENT medical
                                                         staff and
                                                         rotating ENT
                                                         resident
                                                         rosters should
                                                         be reviewed for
                                                         competency
                                                         If not
                                                         competent,
                                                         schedule in-
                                                         service
                                                         training for
                                                         staff who need
                                                         it
                                                         Schedul
                                                         e in-service
                                                         training for
                                                         physicians and
                                                         residents as
                                                         well
------------------------------------------------------------------------
Storage cabinets are not labeled potentially causing     Label
 clean and dirty instruments to be mixed up              clean storage
                                                         cabinets
                                                         ``clean
                                                         endoscope''
                                                         Label
                                                         any container
                                                         that holds
                                                         dirty
                                                         instruments
                                                         ``dirty
                                                         endoscope''
------------------------------------------------------------------------


Topic 7

The process of reprocessing reusable items used to perform a 
transrectal prostate biopsy between patients including transportation, 
decontamination, high level disinfection, sterilization and storage.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Power goes out: weather, earthquake, fire                Resched
                                                         ule cases
                                                         Obtain
                                                         backup power
                                                         sources
                                                         Develop
                                                         a backup plan
                                                         to use other
                                                         facilities
------------------------------------------------------------------------
Nobody in SPD available to receive items (i.e. lumens)   Hire
   Staffing issues                               more staff or
   Lack of communication process                 backup staff
                                                         Use an
                                                         end of shift
                                                         report, morning
                                                         and afternoon
                                                         reports and a
                                                         communication
                                                         board in a
                                                         prominent
                                                         location
------------------------------------------------------------------------
Items missing/left in urology procedure area or in the   Urology
 OR                                                      should assume
   Items picked up by SPD staff inadvertently    the
 from the OR area                                        responsibility
   Items are thrown away after the case          for items used
                                                         during OR
                                                         (operating
                                                         room)
                                                         procedures and
                                                         should perform
                                                         initial
                                                         cleaning prior
                                                         to delivering
                                                         items to SPD
                                                         decontamination
                                                         area
------------------------------------------------------------------------
Incorrect solution or ratio of enzymatic cleaning        Identif
 agent and water used for cleaning                       y correct
                                                         amount of
                                                         enzymatic
                                                         cleaning agent
                                                         purchasing
                                                         container that
                                                         dispense
                                                         correct amount
                                                         of cleaning
                                                         agent or using
                                                         other measuring
                                                         device (i.e.
                                                         cup)                                                         Post
                                                         this
                                                         information at
                                                         the
                                                         decontamination
                                                         sink to avoid
                                                         re-labeling
                                                         each new bottle
                                                         and to identify
                                                         the correct
                                                         solution                                                         Add
                                                         measurement
                                                         markers at 1
                                                         gallon
                                                         intervals to
                                                         act as a visual
                                                         aid for staff
                                                         when they fill
                                                         the sink with
                                                         water------------------------------------------------------------------------
Failure to follow the correct protocol when cleaning     Educate
 the instruments                                         the staff in
                                                         the
                                                         standardized
                                                         processes
                                                         available for
                                                         instrument
                                                         maintenance                                                         Review
                                                         this
                                                         information
                                                         annually                                                         Post
                                                         visual aids and/
                                                         or memory
                                                         joggers to
                                                         assist staff------------------------------------------------------------------------
Contamination occurs during handling                     Establi
                                                         sh strict
                                                         standardized
                                                         procedure for
                                                         handling and
                                                         sterilization
                                                         of the prostate
                                                         needle guide
                                                         device. SPD
                                                         manual H90.1
                                                         guideline (ID/
                                                         SPD Note: this
                                                         should be the
                                                         VA Directive/
                                                         Handbook 7176)
                                                         will be
                                                         followed to
                                                         prevent
                                                         contamination
                                                         (e.g. end user
                                                         rinses the
                                                         dirty device
                                                         with tap SPD
                                                         picks up the
                                                         device the
                                                         device is
                                                         submerged in
                                                         cleaning
                                                         solution
                                                         external and
                                                         internal------------------------------------------------------------------------
Instruction not complete/correct                         For new
                                                         equipment/
                                                         devices
                                                         procedures/
                                                         instructions
                                                         are developed
                                                         using the
                                                         manufacturer's
                                                         guidelines.
                                                         Guidelines are
                                                         attached to the
                                                         new procedure------------------------------------------------------------------------
Failure to follow manufacturer's instructions            Reduce
   Staff is hurried and/or distracted            distractions in
   Staff was never informed of the               the work area
 instructions  
------------------------------------------------------------------------
Brush Issues                                             Establi
   Correct sized brushes not available           sh par levels
   Staff not aware of need to brush channels     for the
   Brushes are dirty or worn                     required sizes
   Reusable brushes are not sterilized at the    of brushes
 end of the day following use   
------------------------------------------------------------------------


Topic 8

The process of assuring sterility of orthopedic implantable devices 
that come in orthopedic loaner instrument trays.

Number of reporting facilities: 9

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Manufacturers recommendations for cleaning instruments   SPD
 not sent with tray and not on file with SPD             staff to keep
                                                         files of
                                                         manufacturers
                                                         recommendations
                                                         for cleaning
                                                         instruments on
                                                         all instruments
                                                         received on
                                                         loaner trays
                                                         for staff's
                                                         future
                                                         reference                                                         Provide
                                                         staff with
                                                         manufacturer's
                                                         instructions
                                                         for cleaning
                                                         instruments for
                                                         all instruments
                                                         staff is
                                                         unfamiliar with------------------------------------------------------------------------Breakdown in communication between SPD, OR and/or        Create
 vendor                                                  a handoff form
   SPD releases case cart to OR without          to communicate
 communication of critical information as part of this   critical
 handoff                                                 information
   May not properly deliver orthopedic loaner    between SPD and
 instrument sets/non-biological implants on time         OR for all
   No adherence to 48 hour hold time for         trays
 implants ordered for elective procedures
   Loaner implantable device/instrumentation
 needs are not communicated to OR staff
   Possible case conflicts related to types
 and numbers of similar cases resulting in the
 unavailability of vendor or loaner implant sets
 (multiple cases of same type scheduled on same day)   
------------------------------------------------------------------------Not enough in house implantable devices to accommodate   Purchas
 emergent cases                                          e additional
                                                         implantable
                                                         devices
                                                         commonly needed
                                                         in emergent
                                                         cases------------------------------------------------------------------------Defect in instrument or cleaning of the instrument       Hold an
 overlooked                                              educational in-
   Tech may be distracted or overworked          service 
------------------------------------------------------------------------Equipment malfunction (e.g. ultrasonic cleaner, washer/  Perform
 sterilizer)                                             periodic
                                                         maintenance
                                                         checks on such
                                                         equipment to
                                                         ensure proper
                                                         performance 
------------------------------------------------------------------------Delays in getting the releases signed by the approving   If
 official                                                release can
                                                         only be signed
                                                         by one person,
                                                         consider
                                                         finding a
                                                         backup such as
                                                         a charge nurse
                                                         to ensure the
                                                         process is not
                                                         delayed------------------------------------------------------------------------
Implant arrives late from vendor                         Departm
                                                         ent of surgery
                                                         and Prosthetics
                                                         to develop a
                                                         process to
                                                         ensure timely
                                                         arrival of
                                                         implants to
                                                         allow full
                                                         biological
                                                         testing
                                                         verification
                                                         (72 hours prior
                                                         to surgery)
------------------------------------------------------------------------


Topic 9

The process of communicating positive biological test results from 
steam, EtO, and plasma sterilizers to the Chief of Staff, Chief of 
Surgical Service, Operating Room Supervisor and Infection Control.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Positive biological indicator results might not be       Purchas
 detected and communicated in a timely way due to        e and implement
 limitations of current equipment                        new biological
                                                         indicator with
                                                         capability of
                                                         rapid
                                                         biological
                                                         testing 
                                                         Purchas
                                                         e biological
                                                         indicator with
                                                         alarm function
                                                         for positive
                                                         results                                                        ID/SPD Note:
                                                         This is not
                                                         available for
                                                         any except for
                                                         Rapid readout
                                                         and it can give
                                                         false
                                                         negatives.                                                        Training and
                                                         quality
                                                         assurance
                                                         checks must be
                                                         in place to
                                                         monitor the
                                                         Biological test
------------------------------------------------------------------------
Positive biological indicator results might not be       Coordin
 detected in a timely way due to coordination between    ate SPD and Lab
 SPD and Lab and workstation setup in Lab. Lab           functions to
 personnel could be unaware of the result                improve
                                                         workflow and
                                                         tracking
                                                         Revise
                                                         workstation
                                                         setup and
                                                         implement shift
                                                         change tracking
                                                         sheet in Lab
                                                         Set
                                                         timers to alarm
                                                         during testing
                                                         to prompt lab
                                                         personnel to
                                                         check for
                                                         results                                                        ID/SPD Note:
                                                         Biological
                                                         monitoring is
                                                         self contained
                                                         and should be
                                                         read and
                                                         documented in
                                                         SPD. They
                                                         should be
                                                         checked several
                                                         times during
                                                         the day.
------------------------------------------------------------------------
Lack of rapid communication of positive biological       Develop
 indicator results from Medical Supply Technician to     procedure for
 Chief of Staff and Infection control Nurse because it   reporting
 must go through several administrative tiers before     positive
 reaching them                                           biological
                                                         indicator
                                                         readings under
                                                         current SPD
                                                         configuration.
                                                         Procedure
                                                         should include
                                                         an algorithm of
                                                         responsibility
                                                         and authority
                                                         to report
                                                         positive
                                                         biological
                                                         indicator
                                                         results
                                                         procedure
                                                         posted in
                                                         incubator/prep
                                                         room
------------------------------------------------------------------------
Indicator result is not detected due to:                 Select,
   Lack of proper equipment                      purchase, and
   Positive biological indicator not perceived   implement new
 as needing immediate action                             incubator
   Change shift unaware of pending tests or      systems that
 available results                                       include alarms
                                                         and with
                                                         capability of
                                                         rapid
                                                         incubation                                                         ID/SPD Note:
                                                         Rapid Readout
                                                         is not approved
                                                         in the VA due
                                                         to false
                                                         readings. If
                                                         ampoules are
                                                         not placed in
                                                         the incubator
                                                         correctly a
                                                         false reading
                                                         will be
                                                         indicated by
                                                         the reader.                                                         Periodi
                                                         c education of
                                                         staff members
                                                         Coordin
                                                         ate SPD and Lab
                                                         functions to
                                                         improveworkflow
                                                         andtrackingproc
                                                         ess
                                                         lab
                                                         checks samples
                                                         several times
                                                         each day
                                                         trackin
                                                         g systems for
                                                         negative and
                                                         positive test
                                                         results (record
                                                         log)
                                                         Impleme
                                                         nt change of
                                                         shift hand off
                                                         tool for lab
------------------------------------------------------------------------
Supervisor not available when reporting positive         Designa
 biological indicator                                    te a back up
                                                         person
                                                         SPD
                                                         will develop a
                                                         call tree of
                                                         critical and
                                                         emergency
                                                         numbers of key
                                                         personnel.
                                                         Distribute call
                                                         tree to all
                                                         major services
                                                         and a copy
                                                         provided to the
                                                         patient safety
                                                         office
------------------------------------------------------------------------
Biologics being read in more than one area of the        Read
 facility increased likelihood of errors occurring       all biological
                                                         results in lab------------------------------------------------------------------------
Sterilization log not accurate or illegible              Double
                                                         check
                                                         sterilized
                                                         items with list
                                                         Educate
                                                         staff to
                                                         identify
                                                         instruments
                                                         individually or
                                                         by specific
                                                         name
                                                         minimiz
                                                         e distractions
                                                         through
                                                         controlling
                                                         work flow
                                                         Create
                                                         a computer
                                                         spreadsheet to
                                                         replace
                                                         handwritten log
------------------------------------------------------------------------
Reading of biological indicators on weekends or          Establi
 holidays                                                sh a 24/7
                                                         reading of
                                                         biological
                                                         indicators
------------------------------------------------------------------------
Lack of clear understanding on reporting process of      Increas
 positive biological indicators                          e education on
                                                         biological
                                                         indicators
                                                         Develop
                                                         procedure for
                                                         reporting
                                                         positive
                                                         biological
                                                         indicator
                                                         readings under
                                                         current SPD
                                                         configuration.
                                                         Procedure
                                                         should include
                                                         an algorithm of
                                                         responsibility
                                                         and authority
                                                         to report
                                                         positive
                                                         biological
                                                         indicator
                                                         results
                                                         procedure
                                                         posted in
                                                         incubator/prep
                                                         room
------------------------------------------------------------------------
Unclear process for follow up on load that is positive   Impleme
 after used on the patient                               nt a team for
                                                         recall process
                                                         Write
                                                         charter for
                                                         team
                                                         Follow
                                                         up on (used
                                                         instruments
                                                         affected by a
                                                         recall)
                                                         instruments re-
                                                         portedtoInfecti
                                                         oncontrolcoordi
                                                         nator
------------------------------------------------------------------------

Topic 10
The process of disinfecting an infusion pump after patient use 
including transportation and storage.

Number of reporting facilities: 8

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
When staff is on leave, disinfection activity is         Hire
 delayed                                                 more SPD
                                                         technicians to
                                                         ensure full
                                                         service during
                                                         planned and
                                                         unplanned leave
                                                         Impleme
                                                         nt change in
                                                         infusion pump
                                                         flow where the
                                                         pump travels
                                                         with the
                                                         patient when
                                                         transferred to
                                                         another unit to
                                                         reduce the
                                                         frequency at
                                                         which the pump
                                                         and pole must
                                                         be disinfected
------------------------------------------------------------------------
Infusion pumps and poles are placed back into use       ID/SPD Note: Any
 without a thorough disinfection                         infusion pumps
   Unable to discern if pump is clean or dirty   or their
   Pump is not considered a gross                associated
 contamination and is only `wiped down'                  equipment that
                                                         are not covered
                                                         with a bag
                                                         labeled with
                                                         the date
                                                         cleaned is to
                                                         be considered
                                                         dirty and must
                                                         be cleaned
                                                         before being
                                                         used on a
                                                         patient, There
                                                         is no need to
                                                         bag used pumps,
                                                         they are a
                                                         class 1 medical
                                                         device and are
                                                         not considered
                                                         grossly soiled.
                                                         They are
                                                         transported
                                                         throughout the
                                                         medical centers
                                                         attached to
                                                         tubing and the
                                                         patient.
                                                         `Red
                                                         Bag'
                                                         discontinued
                                                         infusion pumps
                                                         and poles prior
                                                         to removal from
                                                         patient's room
                                                         to prevent
                                                         accidental re-
                                                         use before
                                                         disinfection
                                                         Send
                                                         all infusion
                                                         pumps and poles
                                                         to SPD for a
                                                         thorough
                                                         disinfecting
                                                         process after
                                                         discontinued
                                                         from use
                                                         All
                                                         infusion pumps
                                                         and poles
                                                         should be
                                                         picked up by
                                                         SPD and receive
                                                         complete SPD
                                                         cleaning prior
                                                         to reuse
                                                         Cover
                                                         and label clean
                                                         poles and
                                                         infusion pumps
                                                         and store them
                                                         in the SPD
                                                         clean room
                                                         Assign
                                                         one staff
                                                         member at every
                                                         shift to ensure
                                                         dirty infusion
                                                         pumps are not
                                                         being used and
                                                         are being taken
                                                         to the dirty
                                                         room
------------------------------------------------------------------------
SPD is not notified of soiled pumps                      Establi
                                                         sh an SOP for
                                                         routine
                                                         exchange of
                                                         pumps for
                                                         disinfection
                                                         Provide
                                                         a means of
                                                         communication
                                                         for SPD (e.g.
                                                         pagers)------------------------------------------------------------------------SPD is out of infusion pumps                             Identif
   It is an emergent situation                   y a method for
   It is the weekend when SPD is off duty        cleaning
   Shortage due to missing infusion pumps        infusion pumps
                                                         and poles
                                                         appropriate for
                                                         emergent
                                                         situations
                                                         Provide
                                                         education for
                                                         nursing staff
                                                         on appropriate
                                                         circumstances
                                                         and techniques
                                                         for cleaning
                                                         infusion pumps
                                                         Extend
                                                         operating hours
                                                         of SPD
                                                         Recomme
                                                         nd that SPD
                                                         deliver
                                                         multiple (e.g.
                                                         four or more)
                                                         clean pumps to
                                                         acute areas
                                                         late Friday
                                                         afternoon to
                                                         ensure clean
                                                         pumps are
                                                         available in
                                                         each area for
                                                         use on the
                                                         weekend
                                                         Establi
                                                         sh and utilize
                                                         systems
                                                         tracking method
                                                         for infusion
                                                         pumps------------------------------------------------------------------------Staff unaware of proper cleaning procedure or cleaning   Develop
 solutions to use when cleaning infusion pumps and       SOP for
 poles                                                   cleaning
                                                         infusion pumps
                                                         and poles
                                                         Educate
                                                         staff
                                                         periodically on
                                                         proper methods
                                                         for cleaning
                                                         infusion pumps
                                                         Provide
                                                         cognitive aids
                                                         near the
                                                         cleaning areas------------------------------------------------------------------------SPD staff not available on weekends to clean pump        Have
                                                         enough pumps on
                                                         hand to carry
                                                         the staff
                                                         through the
                                                         weekend
                                                         Hire a
                                                         weekend SPD
                                                         shift------------------------------------------------------------------------


Topic 11

The process of using a pre-vacuum steam sterilizer in SPD including 
verifying testing (e.g. Bowie-Dick, biological), reviewing printouts 
(to determine sterilization parameters were met, signature of reviewer, 
content list (detailed enough to enable item[s] retrieval if necessary) 
and documentation of all required aspects of sterilization process.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Power outage                                             Have
                                                         backup power to
                                                         run at least
                                                         one sterilizer
                                                         on the supply
                                                         allocated
                                                         Have an
                                                         adequate supply
                                                         of sterile
                                                         supplies on
                                                         site for a
                                                         short term
                                                         power outage
                                                         Have a
                                                         backup plan
                                                         that includes
                                                         notifying
                                                         another
                                                         facility to
                                                         provide needed
                                                         supplies until
                                                         process is up
                                                         and running
                                                         again------------------------------------------------------------------------No water/steam for sterilizer                            Approac
   Steam generator may not be working            h other
   Connectivity between generator and water      facilities for
 may not be working                                      assistance
                                                         Develop
                                                         a specific
                                                         contingency
                                                         plan that is
                                                         posed as an
                                                         attachment to
                                                         service
                                                         disaster
                                                         emergency plan
                                                         Teach
                                                         staff trouble
                                                         shooting to
                                                         check
                                                         connectivity
                                                         and correct the
                                                         problem
------------------------------------------------------------------------
Operator failure due to frequent distractions/           Limit
 interruptions                                           phone calls to
                                                         SPD to Nursing
                                                         Unit emergency
                                                         needs 
                                                         Employ
                                                         more operators------------------------------------------------------------------------No process for tracking the minimum amount of time       Purchas
 needed for complete sterilization                       e and implement
                                                         the use of
                                                         timers that
                                                         will start when
                                                         the
                                                         sterilization
                                                         process begins 
------------------------------------------------------------------------Operator chooses wrong cycle                             Existin
                                                         g cycles have
                                                         processes with
                                                         newer
                                                         sterilizers
                                                         that minimizes
                                                         the likelihood
                                                         of the wrong
                                                         cycle being
                                                         chosen                                                         If the
                                                         sterilizer is
                                                         older, or does
                                                         not have such a
                                                         process
                                                         developed,
                                                         create and
                                                         implement a
                                                         process that
                                                         will ensure the
                                                         correct cycle
                                                         will be chosen.
                                                         Then train all
                                                         staff to use
                                                         it.------------------------------------------------------------------------Document wrong load number or date due to misreading
 of calendar, forgetting to read label, or misreading
 label
                                                         Write
   Could be due to rushed or distracted staff    sterilization
                                                         policies and
                                                         procedures to
                                                         include daily
                                                         crossing out of
                                                         the Julian date
                                                         for improved
                                                         accuracy when
                                                         logging dates  
------------------------------------------------------------------------Biological results are not checked over the weekend      Hold
                                                         the delivery of
                                                         operating
                                                         room(OR)
                                                         instruments
                                                         until Monday
                                                         morning when
                                                         biological
                                                         tests can be
                                                         read and
                                                         confirmed                                                        ID/SPD Note:
                                                         Only implants
                                                         are held until
                                                         the results of
                                                         the biological
                                                         are know.
                                                         Biological are
                                                         read at 48
                                                         hours, but can
                                                         be read up to 7
                                                         days,
                                                         Biologicals
                                                         processed on
                                                         Thursday or
                                                         Friday (when
                                                         SPD is closed
                                                         on the
                                                         weekends) may
                                                         be read on
                                                         Monday morning.                                                         Train
                                                         OR staff on how
                                                         to read and
                                                         confirm that
                                                         biological
                                                         tests are
                                                         negative------------------------------------------------------------------------
Information in Load Record is missing or wrong           Write
                                                         contents on
                                                         paper or
                                                         external tape
                                                         prior to
                                                         wrapping to
                                                         ensure
                                                         consistent
                                                         recording of
                                                         pack contents
                                                         during
                                                         preparation and
                                                         packing                                                         Add a
                                                         post check of
                                                         load record,
                                                         with signature,
                                                         after
                                                         sterilization                                                         Have
                                                         team leader
                                                         monitor post-
                                                         check signature                                                         Compare
                                                         load record to
                                                         name of item on
                                                         external tape------------------------------------------------------------------------Insufficient cooling time can lead to condensation       Cool
                                                         the cart at
                                                         least 1 hour to
                                                         minimize
                                                         condensation 
------------------------------------------------------------------------Training of OR and SPD staff not adequate                Ask
                                                         manufacturer's
                                                         technical
                                                         representative
                                                         to observe the
                                                         process and
                                                         make
                                                         suggestions for
                                                         improvement------------------------------------------------------------------------


Topic 12

The process of using the ethylene oxide (EtO) sterilizer within SPD 
including verifying testing (biological), reviewing printouts 
(parameters were met, content list, list of items), content list 
(detailed enough to enable item(s) retrieval if necessary) and 
documenting the results.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Item does not have specified place for storage after     Specify
 removal from chamber (e.g. equipment or supplies not    storage areas
 placed in correct area)                                 and specific
                                                         places for each
                                                         item sterilized
                                                         Barcode
                                                         storage areas
                                                         and check daily
                                                         by scanning bar
                                                         code and visual
                                                         inspection of
                                                         items
                                                         Educate
                                                         and train staff
                                                         on correct
                                                         storage of
                                                         items in SPD------------------------------------------------------------------------No biological indicator placed in load                   Require
   Biological placed in wrong position           two signatures
                                                         for load sheet
                                                         verification
                                                         and biological
                                                         positioning------------------------------------------------------------------------Exposure time for biological indicator not monitored     Recheck
                                                         load when
                                                         removed from
                                                         sterilizer that
                                                         parameters have
                                                         been met for
                                                         sterilization
                                                         if exposure
                                                         time has not
                                                         been monitored------------------------------------------------------------------------Indicator not checked before items removed               Impleme
   No check of printout after cycle              nt double check
                                                         system by
                                                         assigning
                                                         specific SPD
                                                         staff------------------------------------------------------------------------Staff work load too high                                 Keep
                                                         staff numbers
                                                         at an adequate
                                                         level for the
                                                         facility------------------------------------------------------------------------Staff turnover too high                                  Create
                                                         memory joggers
                                                         (posters,
                                                         visual aids) to
                                                         help new staff
                                                         remember
                                                         quickly------------------------------------------------------------------------


Topic 13

The process of using the plasma sterilizer within SPD including 
verifying biological testing, reviewing printouts (to determine 
sterilization parameters were met, signature of reviewer), content list 
(detailed enough to enable item(s) retrieval, if necessary) and 
documentation of all required aspects of the sterilization process.

Number of reporting facilities: 4

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Issues with biological indicators
   Daily control indicators not placed in
 correct location or not used
   Verifying color change
                                                         Pull
NCPS Note: This is applicable for all sterilization      random trays
 monitoring not just for Plasma sterilizers.             and check for
                                                         (chemical)
                                                         indicators and
                                                         submit findings
                                                         to infection
                                                         control
                                                         committee
                                                         Biologi
                                                         cal would run
                                                         in next load
                                                         and first load
                                                         reprocessed
                                                        ID/SPD Note:
                                                         Biological is
                                                         to be run in
                                                         each gas load.
                                                         Post
                                                         signage/memory
                                                         joggers to
                                                         remind staff of
                                                         indicator
                                                         Post
                                                         written
                                                         directions
                                                         Have
                                                         case cart tech
                                                         perform a
                                                         second check
                                                         prior to
                                                         delivering to
                                                         the designated
                                                         area, and a
                                                         third check by
                                                         the end user
------------------------------------------------------------------------
List of instruments that cannot be plasma sterilized     Develop
 not up to date                                          a list of items
                                                         approved for
                                                         plasma
                                                         sterilization
                                                         using
                                                         manufacturer's
                                                         recommendations
                                                         Post
                                                         list near
                                                         sterilizers
------------------------------------------------------------------------
Staff lacks training                                     Place
   Loads incorrectly packed                      each new SPD
   Regarding items processed                     employee with a
   Limitations of the plasma sterilizer          preceptor for
   Information misinterpreted by Technician      the first few
                                                         weeks
                                                         Use
                                                         signage and
                                                         other cognitive
                                                         aids and memory
                                                         joggers to help
                                                         staff
                                                         Conduct
                                                         periodic
                                                         training
                                                         reviews
------------------------------------------------------------------------
Facility SOP is not present or not adequate              Develop
   Does not include manufacturer and VHA         and implement
 guidelines                                              SOP for all
                                                         areas
                                                         Ensure
                                                         SOP contains
                                                         manufacturer
                                                         and VHA
                                                         guidelines
------------------------------------------------------------------------


Topic 14

The process of using steam sterilization in Dental including verifying 
biological testing (Bowie-Dick type test if using a pre-vacuum 
sterilizer), reviewing printouts (to determine if sterilization 
parameters were met, signature of reviewer), content list (detailed 
enough to enable item(s) retrieval, if necessary), and documentation of 
all required aspects of the sterilization process.

Number of reporting facilities: 1

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Ineffective ultrasonic cleaning of instruments           Increas
                                                         e time
                                                         instruments are
                                                         left in
                                                         ultrasonic
                                                         cleaner
                                                         Educate
                                                         staff regarding
                                                         extended time
                                                         in ultrasonic
                                                         cleaning
                                                         machine
                                                         Create
                                                         a visual aid
                                                         with step by
                                                         step
                                                         instruction
                                                         delineating the
                                                         entire
                                                         instrument
                                                         process
------------------------------------------------------------------------
Recontamination                                          Redesig
   Compromised packaging                         n instrument
   Wet packs and tears in bags due to            processing
 sterilizer not functioning properly                     areas to create
                                                         separate areas
                                                         to handle dirty
                                                         and clean
                                                         instruments
                                                         Educate
                                                         staff regarding
                                                         appropriately
                                                         wrapping,
                                                         bagging and
                                                         sealing of
                                                         instruments
                                                         Create
                                                         a visual aid
                                                         with step by
                                                         step
                                                         instructions
                                                         for packaging
                                                         instruments
                                                         Repair
                                                         sterilizer and
                                                         perform
                                                         periodic
                                                         maintenance
                                                         checks
------------------------------------------------------------------------


Topic 15
The process of decontaminating surgical instruments prior to 
sterilization.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Unable to visualize bioburden                            Purchas
   Tiny spaces                                   e magnifying
   Poor vision                                   glass with
   Poor lighting                                 light
   Lack of staff knowledge                       Impleme
                                                         nt mandatory
                                                         eye exam to
                                                         identify staff
                                                         with vision
                                                         troubles
                                                         Install
                                                         more light
                                                         Increas
                                                         e lighting
                                                         wattage
                                                         Clearly
                                                         define
                                                         bioburden
                                                         Increas
                                                         e in-servicing,
                                                         training
                                                         Install
                                                         cognitive aids
                                                         to help
                                                         identify
                                                         bioburden
------------------------------------------------------------------------
Staff rushed                                             Increas
   Increased demand for equipment                e staff to
   Staff shortage                                ensure backup
                                                         Use a
                                                         temp agency as
                                                         needed
                                                         Increas
                                                         e inventory of
                                                         surgical
                                                         instruments to
                                                         have enough
                                                         instruments to
                                                         support
                                                         surgical
                                                         scheduling
                                                         peaks and
                                                         emergency cases
                                                         Increas
                                                         e availability
                                                         of instruments
                                                         through better
                                                         coordination
                                                         with surgery
                                                         department
------------------------------------------------------------------------
Vendors bring grossly contaminated instruments           Develop
                                                         a Memorandum of
                                                         Understanding
                                                         with vendor and
                                                         SPD
                                                         Support
                                                         addition to
                                                         National
                                                         Contract for
                                                         having vendor
                                                         supplied
                                                         instruments in
                                                         house 48 hours
                                                         prior to case                                                        ID/SPD Note:
                                                         Require that
                                                         the instruments
                                                         remain at the
                                                         VA as required
                                                         by the national
                                                         contract, and
                                                         do not allow
                                                         them to be
                                                         taken back and
                                                         forth.                                                         Vendor
                                                         accountability
                                                         in having
                                                         instruments
                                                         cleaned
                                                         properly before
                                                         bringing them
                                                         in for cases
                                                         Conside
                                                         r purchase of
                                                         one-of-a-kind,
                                                         high use
                                                         instruments to
                                                         decrease
                                                         dependence on
                                                         vendors
                                                         Standar
                                                         dization of
                                                         inventory used
                                                         for cases
                                                         Flexibi
                                                         lity of SPD to
                                                         increase
                                                         staffing the
                                                         day prior to
                                                         cases with
                                                         numerous
                                                         instruments to
                                                         assure thorough
                                                         decontamination
                                                         and processing
------------------------------------------------------------------------
Inappropriate use of the flash sterilizer                See
   hurry to get instrument to sterile field      Topic 20
   instrument not meant to be flashed            Post
                                                         AAMI standards
                                                         and VA Policy
                                                         in OR for flash
                                                         sterilization
                                                         Evaluat
                                                         e need for
                                                         additional
                                                         instrument/sets
                                                         to meet case
                                                         demand and
                                                         project future
                                                         demand in
                                                         interdisciplina
                                                         ry meetings
                                                         between
                                                         surgeons,
                                                         material
                                                         coordinators
                                                         and SPD
                                                         Evaluat
                                                         e SPD process
                                                         to streamline
                                                         and get
                                                         instruments
                                                         returned to OR
                                                         rather than
                                                         have to flash
                                                         sterilize
                                                         Develop
                                                         policy/
                                                         guideline for
                                                         flash
                                                         sterilization
                                                         use------------------------------------------------------------------------Gross contamination present inside hollow instruments,   Provide
 difficult to remove                                     adequate number
                                                         and size of
                                                         receptacles to
                                                         submerge all
                                                         hollow
                                                         instruments in
                                                         water in OR
                                                         Purchas
                                                         e ultrasonic
                                                         cleaner to
                                                         provide proper
                                                         decontamination
                                                         of lumens------------------------------------------------------------------------Covering for transport of contaminated instruments       Purchas
 does not meet infection control standards               e containers
                                                         with fitted
                                                         lids that will
                                                         fit securely
                                                         into c-lockers
                                                         and avoid
                                                         spills
                                                         Purchas
                                                         e stainless
                                                         steel case
                                                         carts with
                                                         doors to
                                                         provide a
                                                         barrier to
                                                         prevent spills
                                                         Use
                                                         dumbwaiter
                                                         elevator
                                                         between OR and
                                                         SPD------------------------------------------------------------------------Next day schedule not always accurate or subject to      Add a
 late changes due to bed availability and SPD not        night shift in
 prepared for first morning cases                        addition to
                                                         call person to
                                                         cover routine
                                                         processing from
                                                         late cases
                                                         including a
                                                         communication
                                                         process for
                                                         what sets are
                                                         needed for next
                                                         day cases                                                        ID/SPD Note: all
                                                         instruments are
                                                         to be put up
                                                         and ready for
                                                         use, as soon
                                                         after use as
                                                         possible and
                                                         should never be
                                                         down overnight                                                         Keep
                                                         communication
                                                         open between OR
                                                         and SPD------------------------------------------------------------------------Errors occur due to repetitive and tedious nature of     Create
 role                                                    rewards and
                                                         incentives for
                                                         job well done
                                                         Recogni
                                                         ze SPD staff
                                                         who perform
                                                         well at staff
                                                         meetings
                                                         Pay
                                                         market rate and
                                                         give a higher
                                                         level pay for
                                                         staff with
                                                         experience
                                                         Hire
                                                         people who
                                                         clearly
                                                         understand the
                                                         importance of
                                                         this role and
                                                         take pride in
                                                         performing
                                                         exceptional
                                                         work each day
                                                         Impleme
                                                         nt a mandatory
                                                         rotation of SPD
                                                         staff through
                                                         different
                                                         duties
                                                         throughout the
                                                         day                                                        ID/SPD Note:
                                                         While cross
                                                         training is
                                                         encouraged
                                                         permanently
                                                         scheduled
                                                         rotations are
                                                         not
                                                         recommended.
------------------------------------------------------------------------
Inconsistent process of using manufacturer recommended   Create
 guidelines for instrument cleaning                      a file for
                                                         manufacturer
                                                         recommended
                                                         guidelines 
------------------------------------------------------------------------


Topic 16

The process of preparing surgical instruments for sterilization 
including preparing the surgical instrument trays (e.g. inspecting for 
bioburden, checking for instrument usability, correct instruments in 
correct trays) and packaging instruments.

Number of reporting facilities: 11

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Lack of staff with knowledge necessary to meet the       Develop
 demands of the hospital                                 SOPs to reflect
   Non-standardized procedures                   the
   Manufacturer or vendor did not provide        requirements of
 protocol                                                each scope
   Incomplete training of staff
   Lack of knowledge of instrument use
   Staff unfamiliar with seldom used
 instruments
   All inclusive education not provided prior
 to use of equipment     ------------------------------------------------------------------------Water and enzymatic cleaner is not measured but          Mark
 `eyeballed' due to lack of measurable containers and    sink to reflect
 portion dispensing enzymatic pumps                      the correct
                                                         amount of water
                                                         for scope
                                                         cleaning ------------------------------------------------------------------------
Incorrect instruments placed in container               Random tray
   Non-standardized nomenclature for             monitoring by
 instruments                                             SPD and OR
   Incorrect label                               staff to ensure
   Inconsistent measurement of instruments       sterilization,
   Similar/look-alike instruments                completeness of
                                                         instruments,
                                                         and
                                                         functionality
                                                         of instruments
                                                         Write
                                                         SOP for
                                                         nomenclature
                                                         and labeling
                                                         Affix a
                                                         permanent
                                                         measurement
                                                         tool to area
                                                         where trays are
                                                         assembled
                                                         Obtain
                                                         detailed visual
                                                         aid poster and
                                                         hang closer to
                                                         where trays are
                                                         assembled------------------------------------------------------------------------Washer/Sterilizer breaks down                            Purchas
                                                         e another
                                                         washer/
                                                         sterilizer------------------------------------------------------------------------Malfunctioning instrument is identified by doctor and    Adequat
 disposed of and not reported to SPD                     e documentation
   Incorrect count sheets                        of number and
   Instrument is not replaced in inventory       types of
   Loss of instrument not known until it is      instruments
 needed                                                  coming in and
                                                         going out of
                                                         the OR
                                                         Locate
                                                         any missing
                                                         instruments/
                                                         equipment
                                                         Replace/
                                                         repair
                                                         malfunctioning
                                                         instruments/
                                                         equipment
                                                         Increas
                                                         e inventory of
                                                         instruments------------------------------------------------------------------------Malfunctioning instrument is not identified              Random
   Broken instruments or instruments needing     tray monitoring
 repair are recycled into service without repair         by SPD and OR
                                                         staff to ensure
                                                         sterilization,
                                                         completeness of
                                                         instruments,
                                                         and
                                                         functionality
                                                         of instruments
                                                         Write
                                                         SOP for visual
                                                         inspection when
                                                         cleaning
                                                         instruments to
                                                         check for
                                                         bioburden or
                                                         malfunctioning
                                                         instruments------------------------------------------------------------------------Instruments not available                                Constru
   Vendor/Loaner tray not received 48 hours in   ct a Memorandum
 advance                                                 of
                                                         Understanding
                                                         (MOU) between
                                                         SPD staff and
                                                         the vendor that
                                                         discusses
                                                         appropriate
                                                         time periods
                                                         for receiving
                                                         instruments and
                                                         equipment                                                        (ID/SPD comment:
                                                         and make sure
                                                         the MOU is
                                                         agreed to by
                                                         all parties and
                                                         is followed.)------------------------------------------------------------------------Failed to visually inspect for bioburden                 Write
   Blood, bone, fecal matter left on             SOP for visual
 instrument                                              inspection when
   Inadequate lighting                           cleaning
                                                         instruments to
                                                         check for
                                                         bioburden or
                                                         malfunctioning
                                                         instruments
                                                         Increas
                                                         e lighting in
                                                         areas where
                                                         visual
                                                         inspection
                                                         occurs------------------------------------------------------------------------Failure to document counts on the original count sheet   Revise
                                                         policy to
                                                         include the
                                                         instructions
                                                         that upon
                                                         return of the
                                                         surgical trays
                                                         sent from the
                                                         OR the original
                                                         count sheet is
                                                         returned to SPD
                                                         with the
                                                         surgical set
                                                         Communi
                                                         cate this
                                                         revision with
                                                         the OR staff
                                                         and implement
                                                         the requirement
                                                         to complete the
                                                         instrument
                                                         count on the
                                                         original count
                                                         sheet
                                                         Have
                                                         SPD revise the
                                                         count sheet
                                                         using the count
                                                         sheet format
                                                         approved by the
                                                         VISN, SPD and
                                                         nurse managers------------------------------------------------------------------------
The serial number of the scope is not written on the     Place
 sterilizer logs to allow for tracking scope to          patient
 sterilizer                                              identification
                                                         and scope on
                                                         sterilizer
                                                         record to allow
                                                         for tracking of
                                                         scope to
                                                         patient
------------------------------------------------------------------------
Failure to visually inspect for bioburden                Designa
   Bioburden not recognized                      te an educator
   Light/Magnification not used                  for SPD to show
                                                         examples of
                                                         bioburden
                                                         Seek
                                                         better
                                                         magnifying
                                                         options
                                                         Post
                                                         visual aids
                                                         identifying
                                                         bioburden
                                                         Impleme
                                                         nt mandatory
                                                         eye exam to
                                                         identify any
                                                         staff in need
                                                         of vision
                                                         correction
------------------------------------------------------------------------
Failure to replace instrument                            Have an
   Instrument not available due to being         additional
 repaired                                                contract for
   Instrument not in inventory                   repairs
   Instrument not returned from repair           Place
                                                         an order for
                                                         loaner
                                                         instruments 
------------------------------------------------------------------------
Lack of staff training and process education (e.g.       Impleme
 material incorrectly wrapped, or damaged wrapping,      ntation of a
 incorrect load alignment, cart packed too tightly)      structured
                                                         educational
                                                         program
                                                         consisting of
                                                         annual
                                                         competency,
                                                         supervisor
                                                         observation and
                                                         certification
                                                         testing
                                                         Include
                                                         a preceptor
                                                         program for new
                                                         employees
                                                         Impleme
                                                         nt mandatory
                                                         daily rotation
                                                         though
                                                         different
                                                         duties in SPD 
------------------------------------------------------------------------


Topic 17

The process of coordinating and communicating the availability of 
needed equipment and supplies between the OR and SPD.

Number of reporting facilities: 9

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Difficult to find where Operating Room (OR) supplies     Create
 are stored                                              a table of the
                                                         inventory of
                                                         the supplies
                                                         and their
                                                         locations
                                                         Standar
                                                         dize locations
                                                         of supplies
------------------------------------------------------------------------
Scheduling issues                                        Create
   Scheduling changes made over weekend          an OR
   Elective surgery scheduled between already    scheduling
 scheduled cases                                         protocol that
   Patient scheduled for first case does not     will outline
 show up                                                 the proper
   No standardized means of communication for    procedure for
 scheduling changes                                      changing OR
                                                         cases
                                                         Also,
                                                         look into
                                                         feasibility of
                                                         purchasing an
                                                         OR scheduling
                                                         package
                                                         Assign
                                                         each service a
                                                         designated
                                                         surgery
                                                         scheduler who
                                                         is aware of
                                                         patient's
                                                         travel
                                                         constraints and
                                                         takes these
                                                         constraints
                                                         into account
                                                         when making the
                                                         surgery
                                                         schedule
                                                         Identif
                                                         y a point of
                                                         contact so that
                                                         if the OR/
                                                         scheduler have
                                                         questions
                                                         regarding the
                                                         surgery it can
                                                         be clear who
                                                         should be
                                                         contacted------------------------------------------------------------------------Lack of communication and/or miscommunication            OR and
                                                         SPD staff must
                                                         share info
                                                         across
                                                         departmental
                                                         lines as well
                                                         as throughout
                                                         all levels of
                                                         management
                                                         Provide
                                                         clear upfront
                                                         directions to
                                                         the staff that
                                                         will enable
                                                         them to carry
                                                         out tasks more
                                                         timely and
                                                         avoid
                                                         unnecessary
                                                         delays
                                                         Have up-
                                                         to-date
                                                         information
                                                         available
                                                         Periodi
                                                         c review of
                                                         equipment/
                                                         supply lists is
                                                         a feasible way
                                                         to monitor
                                                         inventory and
                                                         enhance the
                                                         coordination of
                                                         quality care
                                                         SPD
                                                         staff must have
                                                         sufficient
                                                         knowledge of
                                                         policies and
                                                         procedures
                                                         related to
                                                         order control
                                                         and inventory
                                                         management
                                                         Procedu
                                                         re
                                                         verification.
                                                         Utilize a write
                                                         down, ``read
                                                         back''
                                                         procedure to
                                                         endure total
                                                         understanding
                                                         by both staff
                                                         members------------------------------------------------------------------------Communication Issues between SPD and OR                  Establi
   No communication with OR regarding being      sh a process
 out of supplies                                         for
   Miscommunication between provider             communication
 (requestor) staff and OR/SPD (ordering) staff for new   of missing
 or changed equipment request                            items between
   Miscommunication between OR staff, nursing,   OR and SPD
 SPD and Medical/Surgical department secretary when      liaison to
 order is placed resulting in incorrect equipment        communicate
 order                                                   with SPD night
   OR not fully aware of SPD process             supervisor on a
   Lack of communication between SPD and OR      daily basis
 due to limited phones and contact information           prior to setup
                                                         of cases in OR
                                                         Collect
                                                         data on number
                                                         of OR delays/
                                                         cancellations
                                                         related to
                                                         missing
                                                         instruments
                                                         Explore
                                                         feasibility of
                                                         employing an OR/
                                                         SPD trainer
                                                         ensure on going
                                                         consistent
                                                         training of
                                                         staff
                                                         particularly
                                                         focusing on
                                                         communication
                                                         Utilize
                                                         a write down,
                                                         ``read back''
                                                         procedures
                                                         Request
                                                         or to use
                                                         written
                                                         standard
                                                         request
                                                         (including
                                                         date, subject-
                                                         specifics).
                                                         Request form is
                                                         put on shared
                                                         drive, all
                                                         parties will
                                                         use a voting
                                                         button for
                                                         department
                                                         review and
                                                         check off
                                                         Before
                                                         completing the
                                                         purchasing
                                                         request,
                                                         medical/
                                                         surgical
                                                         program
                                                         secretary sends
                                                         to SPD/OR/
                                                         Nursing mail
                                                         group the list
                                                         of ordered
                                                         equipment and
                                                         supplies------------------------------------------------------------------------
                                                         Each
                                                         department
                                                         reviews for
                                                         errors and
                                                         sends back a
                                                         confirming
                                                         email                                                         During
                                                         OR orientation,
                                                         have new OR
                                                         staff rotate in
                                                         SPD to
                                                         reinforce the
                                                         importance of
                                                         timely
                                                         communication
                                                         between the OR
                                                         and SPD                                                         OR room
                                                         extensions
                                                         posted in SPD
                                                         telephones with
                                                         multiple phone
                                                         lines will be
                                                         installed in
                                                         SPD------------------------------------------------------------------------Issues with vendors                                      Require
   Vendor drops off borrowed instrument kits     vendors to
 but it is unknown if all kits have been delivered       provide a list
   Loaner trays not received in a timely         of items in
 fashion from vendor or sales representative resulting   instrument kits
 in late arrival in instruments and possible delays in   as well as the
 procedures                                              number of
   Vendor contact info is unavailable or         trays, weight
 inaccurate which causes barriers for communication      of trays, type
   Mixing of vendor and facility instruments     of tray and
 resulting in lost instruments                           contents of
                                                         each tray. SPD
                                                         will be
                                                         informed of the
                                                         number of trays
                                                         to inspect and
                                                         verify that
                                                         this is
                                                         accurate upon
                                                         delivery from
                                                         vendor   ------------------------------------------------------------------------Instruments not available delivered to wrong dept,       Establi
 mislabeled, unable to locate                            sh a process
                                                         for
                                                         communication
                                                         of missing
                                                         items between
                                                         OR and SPD (OR/
                                                         SPD liaison to
                                                         communicate
                                                         with SPD night
                                                         supervisor on a
                                                         daily basis
                                                         prior to setup
                                                         of cases in OR                                                         Take a
                                                         picture of
                                                         instruments in
                                                         loaner trays------------------------------------------------------------------------Case carts inaccurate                                    Standar
   Wrong Cart                                    dize procedure
   Missing supplies                              names and case
                                                         cart codes
                                                         needed for
                                                         those
                                                         procedures ------------------------------------------------------------------------


Topic 18

The process of maintaining the primary storage environment including: 
monitoring room temperature, humidity, the number of air exchanges per 
hour, pest control; maintaining the storage arrangement (e.g. stock 
rotation, avoiding outdates); and maintaining cleanliness for 
sterilized instrumentation, equipment and supplies in SPD.

Number of reporting facilities: 7

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Monitoring room temperature, humidity, and number of     Develop
 air exchanges per hour                                  and implement a
   Temperature and humidity are not controlled   Standard
 or tracked                                              Operating
   No assessment of temperature and humidity     Procedure for
 if staff not physically present                         the
   Records of temperature and humidity are not   environmental
 maintained                                              controls of the
   No monitoring of air exchanges                storage areas
   Negative and positive pressure is not         Purchas
 monitored                                               e and implement
   Potential to tamper with thermostat           temperature and
                                                         humidity
                                                         loggers to
                                                         continuously
                                                         monitor the
                                                         area
                                                         Install
                                                         an alarm that
                                                         will sound if
                                                         the area's
                                                         temperature or
                                                         humidity goes
                                                         out of range
                                                         and will alert
                                                         the physical
                                                         plant
                                                         Downloa
                                                         d and print
                                                         data
                                                         periodically
                                                         (e.g. weekly)
                                                         from the logger
                                                         Print
                                                         data for out of
                                                         range
                                                         deficiencies
                                                         and report to
                                                         facilities
                                                         engineering,
                                                         Patient Safety
                                                         Manager, and
                                                         Infection
                                                         Control
                                                         Coordinator
                                                         Put in
                                                         to effect a
                                                         system of
                                                         maintaining the
                                                         records
                                                         Educate
                                                         all SPD staff
                                                         that will be
                                                         responsible for
                                                         temperature and
                                                         humidity
                                                         control
                                                         The air
                                                         conditioning
                                                         department
                                                         needs to verify
                                                         and log the
                                                         number of air
                                                         exchanges as
                                                         well as the
                                                         positive and
                                                         negative
                                                         pressures in
                                                         SPD on a
                                                         monthly basis
                                                         In the
                                                         SOP require
                                                         that air
                                                         exchange data
                                                         be kept for 3
                                                         years
                                                         Monitor
                                                         with a
                                                         vanometer
                                                         Place a
                                                         secure cover
                                                         over the
                                                         thermostat------------------------------------------------------------------------Current temperature and humidity recorders require       Develop
 annual calibration resulting in downtime in use; due    a rotation
 to the nature of work schedules, there is a potential   schedule for
 for failures to go undetected for an unacceptable       current
 amount of time                                          recorders to
                                                         allow annual
                                                         calibration
                                                         Try to
                                                         obtain
                                                         temperature and
                                                         humidity
                                                         monitors with
                                                         centralized
                                                         monitoring
                                                         which will wire
                                                         into current
                                                         system in use
                                                         in engineering
                                                         to provide
                                                         computerized
                                                         alarming when
                                                         temperature and
                                                         humidity are
                                                         out of range
                                                         and 24/7
                                                         monitoring------------------------------------------------------------------------Pest control could be an issue if food items are         Do not
 present                                                 allow food or
   Corrugated boxes for shipping could also      drink in any
 bring in pests                                          area except the
   SPD tech does not check for insects daily,    break room
 including in light fixtures                             Post
   No schedule for performing pest control       signage
                                                         indicating
                                                         areas that
                                                         should be clear
                                                         of food
                                                         No
                                                         shipping
                                                         containers (or
                                                         any corrugated
                                                         material)
                                                         should be
                                                         allowed in SPD
                                                         All
                                                         areas should be
                                                         cleaned daily
                                                         Garbage
                                                         should be
                                                         removed daily------------------------------------------------------------------------
                                                         Develop
                                                         an SOP for
                                                         maintenance
                                                         that includes
                                                         checking for
                                                         pests daily in
                                                         all areas
                                                         In this
                                                         SOP, include
                                                         periodic pest
                                                         control in all
                                                         areas
------------------------------------------------------------------------
Maintaining storage arrangement                          Supplie
   Supplies on shelves do not get rotated and    s should be
 checked for outdates                                    obtained,
                                                         monitored, and
                                                         distributed by
                                                         SPD rather than
                                                         individual
                                                         services to
                                                         allow better
                                                         control of
                                                         stock,
                                                         outdates,
                                                         recalls, etc.
                                                         Develop
                                                         a schedule for
                                                         inventory
                                                         rotation to
                                                         prevent
                                                         outdates of
                                                         supplies
                                                         Rotate
                                                         stock so that
                                                         first in is
                                                         first out
                                                         Periodi
                                                         cally (ID/SPD
                                                         Comment:
                                                         weekly, shelves
                                                         must be
                                                         cleaned,
                                                         stocked checked
                                                         for rotation,
                                                         and supplies
                                                         that will
                                                         expire in the
                                                         next seven
                                                         days, or until
                                                         the next
                                                         scheduled
                                                         cleaning and
                                                         checking, will
                                                         be pulled) a
                                                         technician
                                                         should print
                                                         out a log sheet
                                                         showing which
                                                         supplies will
                                                         outdate in the
                                                         next year and
                                                         do a walk
                                                         through of SPD
                                                         to determine
                                                         what supplies
                                                         will need to be
                                                         added to the
                                                         list ensuring
                                                         that items are
                                                         pulled before
                                                         outdate
                                                         Put SPD
                                                         staff in charge
                                                         of all
                                                         inventory for
                                                         disposable and
                                                         reusable
                                                         supplies
------------------------------------------------------------------------
Lack of duplicate instruments for OR and clinic          Make
 procedures may cause delay and postponement of          additional
 procedures                                              instruments
                                                         available
                                                         through
                                                         contract or
                                                         purchase to
                                                         ensure
                                                         availability
                                                         for OR and
                                                         clinic areas
------------------------------------------------------------------------
Maintaining cleanliness for sterilized                   Physica
 instrumentation, equipment and supplies                 lly separate
   No schedule for cleaning the shelving to      clean and
 maintain the cleanliness for sterilized                 sterilized
 instrumentation, equipment and supplies                 instruments,
   Items stored in closed cabinets may have      equipment and
 compromised sterility                                   supplies from
   Carts are not cleaned on a regular basis      the dirty ones
                                                         To
                                                         ensure
                                                         cleanliness in
                                                         the clean room,
                                                         construct the
                                                         floors, walls,
                                                         and ceiling
                                                         with moisture
                                                         proof material
                                                         Periodi
                                                         cally (i.e.
                                                         weekly) wipe
                                                         down all
                                                         shelving and
                                                         storage bins
                                                         that are used
                                                         to store clean
                                                         and sterile
                                                         supplies
                                                         Include
                                                         this in the SOP
                                                         for this area
                                                         Check
                                                         items stored in
                                                         closed cabinets
                                                         for punctures,
                                                         tears,
                                                         outdates, or
                                                         anything that
                                                         may compromise
                                                         the sterility
                                                         of the item
                                                         prior to issue
                                                         Develop
                                                         and implement
                                                         SOP for
                                                         cleaning
                                                         distribution
                                                         carts on a
                                                         regular basis
                                                         as per VA
                                                         Central Office
                                                         for cleaning of
                                                         SPD cleaning
                                                         logs to be kept
                                                         in Business
                                                         service as per
                                                         policy
                                                         Educate
                                                         all SPD staff
                                                         that will be
                                                         responsible for
                                                         cleaning carts
                                                         on new SOP
------------------------------------------------------------------------
SPD staff assigned to decontamination area are not       Educate
 showering at end of the shift                           staff on need
                                                         to use shower
                                                         Post signage
                                                         indicating need/
                                                         requirement to
                                                         use shower
------------------------------------------------------------------------


Topic 19

The process of maintaining the secondary storage environment in the 
operating room including: monitoring room temperature, humidity, the 
number of air exchanges; pest control; storage arrangement, and 
cleanliness for sterilized instrumentation, equipment and supplies.

Number of reporting facilities: 8

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Monitoring temperature, humidity, and the number of      Increas
 air exchanges                                           e the frequency
   Infrequent cleaning of the filters on air     of filter
 conditioning units                                      cleaning to
   No controls in place for monitoring           monthly
 humidity, temperature and the number of air exchanges
 in the procedure rooms and supply storage areas
   Current air exchanges for secondary storage
 areas do not meet 10 air exchanges per hour as
 recommended by SPD handbook ------------------------------------------------------------------------Pest control                                             Impleme
   Food present in inappropriate areas and it    nt weekly pest
 is attracting pests                                     control rounds
   Cardboard boxes, open windows, and other      in the surgical
 penetrations in the building could be allowing pests    suite
 to enter    
------------------------------------------------------------------------Storage arrangement                                      SPD
   Bar code component of generic inventory       storage should
 computer package not utilized                           meet the same
   Instruments not available (out for repair,    standard as OR
 broken, worn out)                                       storage
   Instrument kits incomplete
   Expiration dates not monitored   
------------------------------------------------------------------------
                                                         Periodi
                                                         cally (i.e.
                                                         monthly) a
                                                         technician
                                                         should print
                                                         out a log sheet
                                                         showing which
                                                         supplies will
                                                         outdate in the
                                                         next year and
                                                         do a walk
                                                         through of SPD
                                                         to determine
                                                         what supplies
                                                         will need to be
                                                         added to the
                                                         list ensuring
                                                         that items are
                                                         pulled before
                                                         outdate
------------------------------------------------------------------------
Cleanliness for sterilized instrumentation, equipment    Develop
 and supplies                                            and implement a
   Lack of a SOP which is tailored to the        SOP that is
 facility for cleaning the surgical procedure room       tailored to the
   Wood shelving is used for SPD supplies        facility
   Breaches in traffic control in OR (i.e. non   Increas
 OR staff with inadequate coverings and doors that       e cleaning
 allow access)                                           frequency to
   Sterile supplies are transported to OR        include
 covered with a drape or left uncovered in hallways      cleaning rooms
                                                         regardless of
                                                         use on all
                                                         working days
                                                         Include
                                                         in that SOP,
                                                         designation of
                                                         a housekeeper
                                                         to the surgical
                                                         procedure room
                                                         during
                                                         administrative
                                                         hours to
                                                         promote
                                                         consistent
                                                         cleanliness of
                                                         the procedure
                                                         room
                                                         Replace
                                                         with metal
                                                         shelving
                                                         Post
                                                         signage
                                                         indicating
                                                         personnel
                                                         approved for
                                                         entry
                                                         Educate
                                                         non-OR staff
                                                         who need access
                                                         to OR
                                                         Purchas
                                                         e closed carts
                                                         for these
                                                         purposes
                                                         Post
                                                         signage in
                                                         prominent areas
                                                         indicating
                                                         importance of
                                                         using closed
                                                         carts
------------------------------------------------------------------------


Topic 20

The processes of using sterilizers for flash sterilization in the 
operating room including monitoring the frequency of use, biological 
testing, identification of the date and patient and the item(s) flash 
sterilized, and reviewing printouts to verify sterilization parameters 
are being met.

Number of reporting facilities: 10

------------------------------------------------------------------------
  Potential failure modes, causes and vulnerabilities       Proposed
                      identified:                          solutions:
------------------------------------------------------------------------
Flash sterilization is used too frequently               Ensure
   Issues with instruments                       instrument
   inadequate supply of instrumentation (i.e.,   supply is
 demand for instruments exceeds instrument supply)       greater than
   debris on instruments                         demand (e.g.,
   wet instruments                               purchase more
   integrity of packaging                        of the
   instrument was not sterilized                 frequently used
   missing an instrument                         instruments and
                                                         those that are
                                                         most frequently
                                                         flash
                                                         sterilized)
                                                         Maintai
                                                         n a running
                                                         list of those
                                                         instruments
                                                         that require
                                                         replacing
                                                         Keep
                                                         additional
                                                         instruments
                                                         stocked and
                                                         ready to go
                                                         SPD to
                                                         use magnifying
                                                         lens/lamp
                                                         consistently,
                                                         particularly
                                                         with problem
                                                         instruments
                                                         Operati
                                                         ng room (OR) to
                                                         use enzymatic
                                                         cleaner and
                                                         flush any
                                                         instrument with
                                                         a lumen in the
                                                         OR before
                                                         sending it to
                                                         SPD
                                                         Revise
                                                         tracking log in
                                                         SPD to detect
                                                         wet instruments
                                                         before sending
                                                         them to the OR
                                                         Allow
                                                         more SPD
                                                         personnel to
                                                         attend annually
                                                         training to be
                                                         certified with
                                                         ``SPD level one
                                                         certification''
------------------------------------------------------------------------
SPD Issues                                               Staff
   SPD understaffed at critical times            SPD
   Turn around time in SPD viewed to be too      appropriately
 long                                                    (e.g., hire
   No time for SPD to reprocess doctor           more SPD staff,
 supplied instruments and loaner instruments delivered   consider 24
 later than anticipated                                  hour operation,
                                                         schedule SPD
                                                         staff to meet
                                                         needs of
                                                         reprocessing.)
                                                         Purchas
                                                         e better
                                                         reprocessing
                                                         technologies to
                                                         decrease
                                                         sterilization
                                                         times to
                                                         decrease SPD
                                                         turn-around
                                                         Develop
                                                         a Memorandum of
                                                         Understanding
                                                         (MOU) between
                                                         SPD and OR
                                                         staff, which
                                                         will discuss,
                                                         but is not
                                                         limited to:
                                                         Scheduling,
                                                         expected turn-
                                                         around times
                                                         within SPD,
                                                         expectations of
                                                         OR for initial
                                                         decontamination
                                                         , etc.)
                                                         Do not
                                                         allow doctors
                                                         to have their
                                                         own instruments
                                                         flash
                                                         sterilized--the
                                                         y must be
                                                         brought in
                                                         beforehand and
                                                         reprocessed in
                                                         SPD
                                                         Constru
                                                         ct a MOU
                                                         between vendors
                                                         and SPD for
                                                         loaner or other
                                                         instruments
                                                         (e.g., vendor
                                                         agrees to get
                                                         instruments or
                                                         products to the
                                                         facility within
                                                         a certain time
                                                         period)
------------------------------------------------------------------------
Improper documentation of use of flash sterilization     Write a
 (e.g., staff enters instrument sets in flash            SOP for flash
 sterilization log, but doesn't identify the types of    sterilizers
 instruments; no reason specified for flash              containing the
 sterilization.)                                         most current
                                                         AORN
                                                         information and
                                                         reflect the VHA
                                                         directive 7176
                                                         and provide
                                                         educate
                                                         applicable
                                                         staff members
                                                         on the SOP
                                                         Impleme
                                                         nt a dual layer
                                                         review of flash
                                                         sterilizer
                                                         documentation.
                                                         Revise
                                                         documentation
                                                         form to include
                                                         both
                                                         (Supervisor and
                                                         Center Core SPD
                                                         tech)
                                                         reviewer's
                                                         initials
------------------------------------------------------------------------
Improper procedure followed when using flash             Write
 sterilization (e.g., not sterilized long enough, no     SOP for OR for
 biological indicators used)                             flash
                                                         sterilization
                                                         Increas
                                                         e cognitive
                                                         aids/signage
                                                         near flash
                                                         sterilizers
                                                         (e.g., stating
                                                         what can or
                                                         cannot be flash
                                                         sterilized,
                                                         indicating
                                                         biological
                                                         indicators must
                                                         be used)
                                                         Staff
                                                         training (e.g.,
                                                         so that they
                                                         know to adhere
                                                         to SOPs and
                                                         MOUs)
------------------------------------------------------------------------