[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
                        ENDOSCOPY PROCEDURES AT 
                THE U.S. DEPARTMENT OF VETERANS AFFAIRS: 
                    WHAT HAPPENED, WHAT HAS CHANGED? 

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

                                HEARING

                               before the

                     SUBCOMMITTEE ON OVERSIGHT AND
                             INVESTIGATIONS

                                 of the

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

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 16, 2009

                               __________

                           Serial No. 111-28

                               __________

       Printed for the use of the Committee on Veterans' Affairs

                               ----------
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                     COMMITTEE ON VETERANS' AFFAIRS

                    BOB FILNER, California, Chairman

CORRINE BROWN, Florida               STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas                 CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine            JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South     HENRY E. BROWN, Jr., South 
Dakota                               Carolina
HARRY E. MITCHELL, Arizona           JEFF MILLER, Florida
JOHN J. HALL, New York               JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois       BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia      DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico             GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas             VERN BUCHANAN, Florida
JOE DONNELLY, Indiana                DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia

                   Malcom A. Shorter, Staff Director

                                 ______

              Subcommittee on Oversight and Investigations

                  HARRY E. MITCHELL, Arizona, Chairman

ZACHARY T. SPACE, Ohio               DAVID P. ROE, Tennessee, Ranking
TIMOTHY J. WALZ, Minnesota           CLIFF STEARNS, Florida
JOHN H. ADLER, New Jersey            BRIAN P. BILBRAY, California
JOHN J. HALL, New York

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 
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both printed and electronic versions of the hearing record, the process 
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                            C O N T E N T S

                               __________

                             June 16, 2009

                                                                   Page
Endoscopy Procedures at the U.S. Department of Veterans Affairs: 
  What Happened, What Has Changed?...............................     1

                           OPENING STATEMENTS

Chairman Harry E. Mitchell.......................................     1
    Prepared statement of Chairman Mitchell......................    50
Hon. David P. Roe, Ranking Republican Member.....................     2
    Prepared statement of Congressman Roe........................    50
Hon. Bob Filner..................................................     4
Hon. Steve Buyer.................................................     4
Hon. Timothy J. Walz.............................................     6
Hon. Ileana Ros-Lehtinen.........................................     6
Hon. Corrine Brown...............................................     7
Hon. Paul C. Broun...............................................     8
Hon. Bart Gordon.................................................     8
Hon. Kendrick B. Meek............................................     9

                               WITNESSES

U.S. Department of Veterans Affairs:
    John D. Daigh, Jr., M.D., CPA, Assistant Inspector General 
      for Healthcare Inspections, Office of Inspector General....    11
        Prepared statement of Dr. Daigh..........................    51
    William E. Duncan, M.D., Ph.D., MACP, Associate Deputy Under 
      Secretary for Health, Quality and Safety, Veterans Health 
      Administration.............................................    30
        Prepared statement of Dr. Duncan.........................    55

                       SUBMISSION FOR THE RECORD

Stearns, Hon. Cliff, a Representative in Congress from the State 
  of Florida, statement..........................................    62

                   MATERIAL SUBMITTED FOR THE RECORD

Letters:
    Hon. Steve Buyer, Ranking Republican Member, Committee on 
      Veterans' Affairs, to Hon. George Opfer, Inspector General, 
      U.S. Department of Veterans Affairs, letter dated March 25, 
      2009.......................................................    63
    Hon. George J. Opfer, Inspector General, U.S. Department of 
      Veterans Affairs, to Hon. Harry E. Mitchell, Chairman, 
      Subcommittee on Oversight and Investigations, Committee on 
      Veterans' Affairs, letter dated July 23, 2009 [An identical 
      letter was sent to Hon. David P. Roe, Ranking Republican 
      Member, Subcommittee on Oversight and Investigations, 
      Committee on Veterans' Affairs]............................    63
Post-Hearing Questions and Responses for the Record:
    Hon. Harry E. Mitchell, Chairman, and Hon. David P. Roe, 
      Ranking Republican Member, Subcommittee on Oversight and 
      Investigations, Committee on Veterans' Affairs, to Hon. 
      Eric K. Shinseki, Secretary, U.S. Department of Veterans 
      Affairs, letter dated June 24, 2009, and VA responses......    64


                        ENDOSCOPY PROCEDURES AT
                THE U.S. DEPARTMENT OF VETERANS AFFAIRS:
                    WHAT HAPPENED, WHAT HAS CHANGED?

                              ----------                              


                         TUESDAY, JUNE 16, 2009

             U.S. House of Representatives,
                    Committee on Veterans' Affairs,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 10:30 a.m., in
Room 340, Cannon House Office Building, Hon. Harry E. Mitchell
[Chairman of the Subcommittee] presiding.

    Present: Representatives Mitchell, Space, Walz, Adler, and 
Roe.

    Also Present: Representatives Filner, Brown of Florida, 
Buyer, Gordon, Meek, Broun, and Ros-Lehtinen.

             OPENING STATEMENT OF CHAIRMAN MITCHELL

    Mr. Mitchell. Good morning. And welcome to the Subcommittee 
on Oversight Investigations hearing, ``Endoscopy Procedures at 
the U.S. Department of Veterans Affairs (VA): What Happened, 
What Has Changed?'' This meeting is held on June 16th, 2009, 
and the hearing will come to order.
    I ask unanimous consent that Ms. Brown of Florida, Mr. Meek 
of Florida, Mr. Gordon of Tennessee, Ms. Ros-Lehtinen of 
Florida, and Mr. Broun of Georgia be invited to sit at the dais 
for the Subcommittee's hearing today. Hearing no objections, so 
ordered. Ms. Brown, Mr. Meek, Mr. Gordon, Ms. Ros-Lehtinen, and 
Mr. Broun are invited to the dais.
    I would like to thank everyone for attending today's 
Oversight and Investigations Subcommittee hearing entitled, 
``Endoscopy Procedures at the U.S. Department of Veterans 
Affairs: What Happened and What Has Changed?'' Thank you 
especially to our witnesses for agreeing to testify.
    We are here today to evaluate endoscopy procedures used by 
the Department of Veterans Affairs since this Subcommittee was 
made aware of the improper reprocessing, incorrect usage, and 
substandard cleaning of endoscopy equipment at Murfreesboro, 
Tennessee; Augusta, Georgia; and Miami, Florida. We have 
learned that 53 veterans and maybe more were potentially 
infected with human immunodeficiency virus (HIV) and Hepatitis.
    Additionally, during surprise inspections last month more 
than half of the time VA facilities shockingly did not have 
proper training and guidelines in place for common endoscopy 
procedures. Exposing our veterans to this type of risk is 
unacceptable, and I am outraged that any of our Nation's heroes 
were potentially infected or that they even have to worry about 
that possibility.
    Sadly we have been there before. Time and again we have 
seen the VA violate the trust of those who have bravely served 
this country. These endoscopy errors are yet another reason for 
veterans to lose confidence in a system they rely on for the 
care we owe them.
    Most infuriating is the irony that these veterans were 
undergoing routine medical evaluations to keep them safe and to 
prevent illness, but ultimately, they may be in more danger now 
than before the procedure.
    Although we will hear today from the VA that it is 
difficult to determine whether illnesses diagnosed after these 
procedures resulted from the endoscopies or from unrelated 
exposures, there is no question that shoddy standards--systemic 
across the VA--put veterans at risk and dealt a blow to their 
trust in the VA.
    And I will say it again, whether or not any of these 
veterans contracted illnesses from these procedures, it is 
outrageous that they even have to worry about that possibility.
    In response to these shocking wrongdoings, in December 2008 
and January 2009, all VA medical centers were required to 
review their procedures to ensure that they were in compliance 
with the endoscopy device manufacturer's instructions. Twenty-
seven facilities reported noncompliance.
    I want to hear from the VA today that the Veterans 
Integrated Services Network (VISN) directors have addressed 
these mistakes and that medical centers are now following 
standard protocol. I am also eager to hear what the VA has done 
to ensure that proper policies and training are in place so 
that mistakes like these will not happen again. I expect to 
learn what will be done to care for those who may have been 
exposed to HIV or Hepatitis. And I want to know how they are 
going to regain the trust of the veterans they serve.
    In closing, I would like to acknowledge the VA's 
cooperation as this Subcommittee prepared for today's hearing. 
But despite this cooperation and enhanced transparency with the 
new Administration, we must continue to provide persistent 
oversight to identify problems, motivate improvement, and help 
the VA to provide the safe and thorough care veterans deserve.
    Before I recognize the Ranking Republican Member for his 
remarks, I would like to swear in our witnesses. I ask that all 
witnesses please stand and raise their right hand from both 
panels; the first panel and the second.
    [Witnesses sworn.]
    Thank you. I would now like to recognize Dr. Roe for 
opening remarks.
    [The prepared statement of Chairman Mitchell appears on p. 
50.]

             OPENING STATEMENT OF HON. DAVID P. ROE

    Mr. Roe. Thank you for yielding, Mr. Chairman.
    This very important hearing was scheduled at the request of 
Ranking Member Buyer due to the seriousness of the allegations 
involved in the improper disinfecting and cleaning of 
instruments used during endoscopy procedures such as 
colonoscopies.
    I am pleased we have the opportunity to review what 
procedures were in place at the time in the instances that 
occurred in Augusta, Murfreesboro, and Miami, and what the VA 
has done to address and correct VA-wide problems.
    On December 1, 2008, the VA Medical Center in Murfreesboro, 
Tennessee, identified a problem relating to the reprocessing of 
endoscopic equipment. VA Central Office requested that all 
facilities review their processes to ensure that they were in 
compliance with the manufacturer's instructions. These reviews 
identified significant reprocessing issues at the Augusta VA 
Medical Center and the Miami VA Medical Center. Both of these 
issues required patient notification and testing.
    In February 2009, the VA announced a step-up campaign 
scheduled from March 8 through March 14 during which all VA 
facilities would review the safety procedures and reprocessing 
protocols with special emphasis on retraining of the 
reprocessing endoscopes, establishing an easily tracked 
accountability for instrument processing, and training on 
standard operating procedures by facility leadership.
    VA also began notifying veterans who were in the risk pool 
of potentially affected patients. In total, VA has notified 
10,320 veterans of potential risks. Nine thousand nine hundred 
and fifty of these patients responded to the notification, 633 
declined testing or were appointed for follow up, and 8,596 
veterans were notified of the results of their testing. Out of 
all these veterans who were tested, 13 were found positive for 
Hepatitis B virus, 34 were found positive for Hepatitis C 
virus, and 6 were found positive for HIV.
    While the percentage of infections appear small, the issue 
at hand is the proper processing of equipment and ensuring the 
ultimate safety of those veterans who have placed their trust 
in VA's hands for care.
    On March 25, 2009, Ranking Member Buyer requested an 
Inspector General (IG) investigation be conducted on the VA 
step-up program and to determine if there was a systematic 
problem throughout the VA in meeting the step-up training 
requirements.
    I request unanimous consent to have Ranking Member Buyer's 
letter submitted for the record.
    I am looking forward to hearing the testimony of the Office 
of Inspector General (OIG's) on its investigation into this 
issue. It is troubling that these steps had to be taken, but 
given the possible magnitude of the problem that occurred 
earlier this year, it is reassuring that the VA has taken steps 
to ensure patient safety at the VA medical facilities.
    The safety of our Nation's veterans should be our top 
priority when they come to VA medical centers and out-patient 
clinics for care. When we fail to care for even one veteran 
properly we have failed in our sacred trust. We can do better, 
and we will do better.
    Thank you again, Mr. Chairman, I yield back.
    [The prepared statement of Congressman Roe, and the letter 
from full Committee Ranking Member Buyer to the VA OIG, dated 
March 25, 2009, appear on pages 50 and 63.]
    Mr. Mitchell. Thank you, I would like to now recognize 
Chairman Filner.

              OPENING STATEMENT OF HON. BOB FILNER

    Mr. Filner. Thank you, Mr. Chairman, and I appreciate you 
calling this hearing, and I share your outrage.
    As you stated, this incident is another blow to the trust 
that veterans have in our system. You would think that after 
the initial discoveries and the directive from the VA that 
medical directors would make sure that all of their equipment 
and all of their procedures were brought into line, and yet 
later investigation shows that many, many did not.
    You stated that we have been there before. Whether it was 
dealing with suicide statistics, shredding claims documents, or 
re-dating files, we have been there before, but I think we are 
going to have a different ending to this incident, and I hope 
in future incidents. You pointed to new transparency and new 
cooperation. The VA has been up front with the statistics and 
with the investigation. We all know and every one of us on this 
panel have talked about the lack of accountability in the VA 
system, which leads to the fact that we have been here before.
    I don't think that is going to happen again with this 
Administration or with this Secretary. We have praised him, 
every Member here has praised him, and I will say that there is 
going to be a different accounting of this incident and future 
incidents.
    The Secretary has assured me that there will be 
disciplinary action taken. Of course, disciplinary action 
cannot be taken until the required legal process is complete. 
Although we have been there before, we are not going to have 
the same ending.
    I see a new transparency, I see a new sense of 
accountability. I think people are going to not only take this 
incident and learn from it, but understand that a new era of 
accountability is upon us. Hopefully, this will say something 
to our veterans to restore their trust and faith in the VA.
    Someone asked me in the press today, ``Should a veteran 
have any problem or any doubts or concerns?'' and I said, 
``Sure.'' But, if they become assured by the way that this new 
Administration handles these incidents I think we will have 
restored faith rather than less faith. This hearing is part of 
that assurance, but I have confidence that we are going to have 
a new sense of accountability and transparency in the VA. Mr. 
Chairman, I appreciate you yielding to me.
    Mr. Mitchell. Thank you. Mr. Buyer.

             OPENING STATEMENT OF HON. STEVE BUYER

    Mr. Buyer. Thank you very much Chairman Mitchell and 
Ranking Member Dr. Roe.
    First of all let me thank the VA OIG. Let me thank you for 
your good work. Every year I feel like I work to try to get you 
more people, not less, because you are a multiplier and you 
also do a very good job in the accountability of a very large 
health system.
    We also have a lot of good people who work in the VA, and 
too often when incidents come up like this, I never want the 
entire system to be whitewashed. But at the same time, what 
Chairman Filner has just said, that there is a system of 
accountability. And you know, over the years I have also seen 
here in Washington, DC, that there is always downward 
compression whenever there is an incident that occurs. So 
whether it goes from the Central Office to the VISN to the 
medical center, it is always downward compression, and blame 
people at the lowest levels.
    A couple of things I want to bring out. First of all, the 
reason I asked the IG to become immediately involved in there 
is because I had the really strong gut feeling that this was 
systemic, and you are showing that in fact it is. I also have a 
deep seated concern that this doesn't just impact the VA health 
system, that this impacts the greater health systems in the 
country at large.
    We are able to examine systems and errors in the VA through 
our systems of reports and accounts. So sometimes we can get 
really upset and say whether it is there, or is it transparent 
or not transparent?
    Talk about the decentralized model of health that we have 
in our own country. We don't have these reporting requirements. 
And I am interested to know from VA OIG what contact the VA has 
had with the U.S. Department of Health and Human Services (HHS) 
and with the U.S. Department of Veterans Affairs (DoD), and 
whether the same stand downs, inspections, and certifications 
are being done within DoD. And DoD has its own stove pipe 
health systems. Because if this is happening within the VA, 
what is happening in DoD, what is happening in our greater 
health system? And that really concerns me, because we are 
truly a microcosm of the greater population, and my sense is 
that there are some general greater problems out there.
    The other will be on a timeline, and I will work with the 
IG to get a better understanding for myself I guess with regard 
to the timeline. Because in your appendices when I go back the 
first patient safety advisory on reprocessing medical devices 
was issued in March 6th of 2003. So you are reaffirming the 
facilities the auxiliary water channels on the Olympus 
gastrointestinal endoscopes need to be reprocessed, cleaned and 
highly disinfected and sterilized each time the endoscopy was 
used. This was back in 2003 there was a Central Office concern. 
And wow. I don't know who did or did not have their eye on the 
ball.
    The other issue will rest with the Secretary, and that is I 
am quite certain we will have a lot of different claims that 
are going to be filed on behalf of veterans. This is just my 
opinion alone. Each Member of Congress can have their own 
opinion. But my opinion is that the benefit of the doubt will 
go to the veteran.
    I understand causation and I also understand that there 
will be veterans of whom will find themselves in a difficult 
position. The legal process will somehow force them to prove 
causation that they contracted HIV, was it before or after the 
endoscopy? Did they have Hepatitis before or after the 
endoscope? And let us not do that to the veteran. I think a 
presumption when in doubt here should be placed in behalf of 
the veteran.
    We have truly messed up, and I don't think science is going 
to be able to tell us with 100 percent certainty that they will 
have contacted these viruses before and therefore we don't have 
to pay. That is going to be a judgment on behalf of the 
Secretary. But I just want to be clear on my opinion, when in 
doubt the doubt goes to the veteran.
    I yield back.
    Mr. Mitchell. Thank you. Mr. Walz.

           OPENING STATEMENT OF HON. TIMOTHY J. WALZ

    Mr. Walz. Well thank you, Mr. Chairman and our Chairman of 
the Committee and the Ranking Member for bringing this forward, 
I truly appreciate that, and I appreciate your remarks, 
especially the part about the benefit of the doubt with the 
veterans. Thank you for saying that.
    Also, I would like to say a thank you for your Office of 
Inspector General. I have been talking about this since I have 
been here, the service that you do and the ability to ensure 
quality has always been important, and again the Ranking 
Members knows that this Committee has taken a real strong stand 
on trying to increase those numbers, increase your ability to 
do the job that you need to do, and for that I am very 
appreciative.
    As we get ready to ask some questions today I too would 
echo the sentiments that, as I always say, I am the biggest 
supporter and advocate for the VA, but because of that I will 
also be the biggest critic, and any mistakes we make, it is a 
zero sum game. If one veteran is harmed by the care, that is 
one too many. And I think there are some deep questions here. I 
think the systemic question is the one we are going to have to 
try and get after.
    As we start to ask a few questions here I think some of the 
results you found dealing with this issue and the lack of 
following standard operating procedures (SOPs) leads me to 
believe that there is a culture of disregarding the SOPs that 
probably, more than likely, will run deeper.
    So, Mr. Chairman and Chairman of the Full Committee and 
Ranking Member, I want to say again this is exactly what the 
Oversight and Investigation Subcommittee is supposed to do: to 
provide the oversight. One, to make amends for harm that has 
been done, but even more importantly, to make sure we fix this 
going forward to make sure that we continue to provide the best 
care available to our veterans.
    So I look forward to our witnesses helping us get to that 
point. Because as I have said time and time again, everyone in 
this room, leave no doubt, is totally committed to the care of 
our veterans, and when there are mistakes it is our 
responsibility to bring those forward, to find corrective 
action, put that into place, and make sure that we continue to 
deliver that care.
    And I yield back.
    Mr. Mitchell. Thank you. Ms. Ros-Lehtinen.

         OPENING STATEMENT OF HON. ILEANA ROS-LEHTINEN

    Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman, and 
thank you for the opportunity to participate with you.
    The name of our Miami VA is one in which I am very involved 
in and interested in because I passed the bill to name it the 
Bruce Carter Department of Veterans and Affairs and Medical 
Center, so I know the dedication, the courage, and the 
sacrifice of this brave marine named Bruce Carter, and I know 
his family, and I want the great staff that we have at the VA 
to also hold themselves up to that same standard of care. The 
same strict standards that Bruce Carter had in his valiant, but 
short life, and that all of our veterans have.
    The terrible mistakes that led to 2,446 veterans being 
potentially infected with life-threatening diseases at our 
Miami VA must obviously never be repeated. The VA must put 
their lessons learned from these tragic mistakes to good use. 
They have got much work to do ahead of them to rebuild the 
trust and the bond between the veteran and the VA that is now 
shattered, but it had better start with transparency and 
accountability.
    The VA must be forthcoming with timely and candid 
information so that we can all implement the solutions that are 
addressed in this most excellent Inspector General report, so 
we can implement those solutions promptly.
    Our veterans deserve to know what went wrong, and more 
importantly, that it will never happen to a fellow soldier from 
here on out.
    And I just had three quick questions that I hope that our 
panel will address. I know that in a letter that the 
Subcommittee received General Shinseki stated that the Miami VA 
reviewed the Administrative Investigation Board and they took 
several disciplinary actions, and it included the motions, 
revocation of supervisory ratings, suspensions without pay, 
admonishment, and to my knowledge this is the most aggressive 
set of repercussions so far throughout any facility that is 
currently under review. And I wanted to ask what makes Miami 
staff more culpable of wrong doing and deserving of these 
actions?
    And I thank the Miami VA for implementing the 
recommendations that Kendrick and I had put out for door 
knocking, for reach out fairs, that we want up-to-date 
information on the results of these efforts.
    And lastly, Mr. Chairman, I would like to hear from the 
Miami VA about what steps they are taking to implement the IG 
recommendations to make sure that quality control is held to 
the highest standard.
    Thank you for the time.
    Mr. Mitchell. Thank you. Ms. Brown.

            OPENING STATEMENT OF HON. CORRINE BROWN

    Ms. Brown of Florida. Thank you, Mr. Chairman. Mr. Chairman 
I want to thank you for holding this hearing today on the 
Subcommittee.
    As the only Democratic Member from Florida on the VA 
Committee I take a special interest in all issues relating to 
Florida that come before this Committee.
    The VA came to this Committee in March to inform us of this 
situation, and we were assured that everything was under 
control. Step up week, March 8th through the 14th, had done its 
job and found problems with the self-reporting process. Because 
everything was voluntarily reported, the system worked. All the 
veterans who might have been affected have been contacted and 
testing was under way and this problem was contained.
    Something did not work.
    Now the Inspector General reports that this issue was still 
going on in the same facilities in May!
    In March, we were told that there were 3,260 patients at 
Miami alone who would need to be tested. You assured us that 
the risk of the cross contamination was still small. You also 
assured us that the problem was found and fixed. How many 
patients now? Why was the issue not fixed when the problem was 
first noticed? What happened between March and May that 
procedures and training were not updated? How do you know that 
you are able to fix this problem?
    I am very interested in hearing from the Inspector General, 
and I am also interested in Miami, but I am interested in 
Georgia and Tennessee. We have got to fix this problem wherever 
it exists and make sure it doesn't happen again.
    We passed the largest VA budget in the history of the 
United States, we have got to make sure that we support and 
carry out the day-to-day needs of the veterans. Thank you.
    Mr. Mitchell. Thank you. Mr. Broun.

            OPENING STATEMENT OF HON. PAUL C. BROUN

    Mr. Broun. Thank you, Chairman Mitchell, and thank you 
Ranking Member Dr. Roe, and the Members of this Subcommittee 
for this hearing today, and I appreciate the opportunity to be 
here as we look into endoscopy procedures at the VA.
    This is a matter of great concern to my constituents of the 
10th District in Georgia, which is home of the Charlie Norwood 
VA Center in Augusta. As a former U.S. naval medical officer, 
U.S. marine, and as a physician, I am dedicated to ensuring the 
best care possible for our Nation's military veterans. 
President Calvin Coolidge once said, ``The Nation which forgets 
its defenders will itself be forgotten.'' Now, I agree with the 
President in that statement.
    As Americans, we all owe a debt of gratitude to the men and 
women who throughout our Nation's history have served so 
bravely in defense of liberty.
    Thank you for allowing me to join you today to find out 
what happened, what has changed, and what remains to be 
changed, and I look forward to hearing the testimony of 
witnesses today.
    Thank you, Mr. Chairman. And I yield back.
    Mr. Mitchell. Thank you. Mr. Gordon.

             OPENING STATEMENT OF HON. BART GORDON

    Mr. Gordon. Let me start by saying thank you, Chairman 
Mitchell and Ranking Member Roe, a fellow Tennessean, for 
holding this important hearing on endoscopy procedures at the 
VA Medical Center. I appreciate the opportunity to participate, 
even though I am not a Member of the Veterans' Affairs 
Committee.
    But I want to say from the start that my father, a World 
War II veteran, worked at the VA there at the Alvin C. York 
Center for 27 years. He was a grounds keeper. And when I was in 
high school and later in college, I was a volunteer there, so I 
know firsthand the dedication of those individuals that work at 
the York Hospital.
    But mistakes were no doubt made. However, the VA sought to 
determine which veterans in Murfreesboro, and later in Miami 
and Augusta, were potentially affected by the errors and 
offered expedited blood tests free of charge for them.
    The unfortunate reality is that out of the more than 6,400 
veterans in Middle, Tennessee, who received a colonoscopy 
during the period in question, 26 tested positive for Hepatitis 
B, Hepatitis C, or HIV; all blood-borne diseases.
    And while there may be no way to definitively determine if 
the Murfreesboro VA caused all of these infections, one thing 
is certain, veterans confidence in the VA facilities has been 
shaken. I have heard from many veterans who were relieved that 
they tested negative, but at the same time expressed a sense of 
distrust. One of these veterans who served in Vietnam and is 
100 percent disabled tested negative. However, he told me that 
he will not have another colonoscopy until he can be assured 
that this type of error won't happen again.
    I hope you will address this matter in your testimony and 
consider laying out a plan to rebuild the confidence among 
veterans in Tennessee and the rest of the United States.
    Another concern is how the VA plans to handle the cost 
associated with the treatment of the affected veterans. As I 
mentioned earlier, 26 Middle, Tennessee, veterans tested 
positive for blood-borne diseases. Many of them are required to 
make co-payments for their nonservice-connected treatment at 
the VA service.
    One of my constituents, who tested positive for Hepatitis 
C, recently lost his job. He is only rated 30 percent disabled 
and has great concern about how is he going to afford the 
necessary treatment?
    While there may be no way to determine if the VA endoscopy 
procedure resulted in his infection, it is my hope that the VA 
will consider giving each of the infected veterans the benefit 
of the doubt and pay in full for their care if needed. I hope 
you will address this in your testimony today.
    And finally, I spoke with a veteran late last week who was 
notified on May the 8th, 2009, that he may be at risk of an 
infection and should get tested immediately. The initial letter 
went out in February. This veteran was obviously overlooked. 
What additional steps is the VA taking to ensure that all 
veterans who may have been exposed are properly notified?
    Again, I thank the Chairman and Ranking Member for allowing 
me to participate in this hearing and look forward to the 
testimony of our witnesses.
    Mr. Mitchell. Thank you. Mr. Meek.

           OPENING STATEMENT OF HON. KENDRICK B. MEEK

    Mr. Meek. Thank you very much, Mr. Chairman, Ranking 
Member, for allowing me to be here, not a Member of this 
Committee, but a proud Member of the past 6 years of serving on 
the Armed Services Committee, we deal with a number of issues 
not only facing veterans, but those that are enlisted now.
    I have been looking forward to this day coming for some 
time where we could hear back from the Inspector General and 
hear more from the Veterans Affairs about the level of service 
that veterans are receiving or not receiving.
    As you know, the hospital in question is in my district. 
And Congresswoman Ileana Ros-Lehtinen and I have worked very 
closely together. Congresswoman Brown, serving on this 
Committee, has worked on behalf of veterans in the past, and 
Florida is home to a number of veterans.
    I can tell you, Mr. Chairman, I am beyond disturbed of the 
dates and times that we have been told that this particular 
issue would have been resolved by now only to find out of the 
VA admitting itself that we still have a super problem with 
veterans receiving care and their health care being compromised 
as we sit here in this Committee room.
    I came today to find out if there will be recommendations 
on legislative action to bring about a change immediately, or 
will the proper management be put in place to prevent 
compromising veterans in their health care? We are talking 
about one procedure here, so what is happening with the other 
procedures that are taking place in the VA?
    Now, I do commend the hard working men and women, some of 
whom are veterans that work within the VA, but I am very, very 
concerned and will take out sharp objects against those that 
are not moving in an appropriate way to make sure that this 
doesn't happen again.
    Someone getting fired is not a solution. Someone moving in 
or a number of individuals moving in the right direction and 
making sure that veterans are no longer compromised when they 
go in to get preventive care--preventive care I must add--and I 
don't need to give a speech about the commitment of veterans in 
this country to allow us to salute one flag, but I think the 
least that we can do is give them the utmost confidence that 
when they step through the doors of a VA need it be in Miami, 
Florida, or anywhere in the country and even here in the 
Capital beltway that they know that their health care is not 
being compromised.
    So Mr. Chairman, being a Member of the House and being in 
an investigative body, one of our number one objectives and 
duties here representing the American people and veterans we 
have to be assured and we have to assure our constituents and 
veterans in this country that they are not being compromised 
when they step through the doors of the VA.
    So I comment you and the Ranking Member and other Members 
that are here to show great interest. Some are on other 
Committees but could not be here today on this topic, and I 
look forward to the continued work of this Committee and this 
Congress to assure every veteran that they will not be 
compromised when they walk through the doors of the VA.
    So I am looking forward to the Inspector General's report. 
I am looking forward to hearing recommendations on how we can 
improve not only a level of care, but assure every veteran that 
they are not compromised, especially when it comes down to 
human error and lack of procedures. So I look forward to the 
testimony, sir.
    Mr. Mitchell. I ask unanimous consent that all Members have 
5 legislative days to submit a statement for the record. 
Hearing no objections, so ordered.
    At this time I would like to welcome panel one to the 
witness table. Joining us on the first panel is Dr. John Daigh, 
Assistant Inspector General for Healthcare Inspections for the 
Office of Inspector General, U.S. Department of Veterans 
Affairs. Dr. Daigh is accompanied by Dr. George Wesley, 
Director of Medical Consultation and Review in the Office of 
Healthcare Inspections for the Office of Inspector General; Dr. 
Jerome Herbers, Associate Director of Medical Consultation and 
Review in the Office of Healthcare Inspections for the Office 
of Inspector General; and Dr. Limin Clegg, Director of the 
Biostatistics Division at the Office of Inspector General.
    I ask that all witnesses stay within 5 minutes of their 
opening remarks. Your complete statements will be made part of 
the record.
    At this time, I would like to recognize Dr. Daigh for up to 
5 minutes.

STATEMENT OF JOHN D. DAIGH, JR., M.D., CPA, ASSISTANT INSPECTOR 
    GENERAL FOR HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR 
 GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY 
      JEROME HERBERS, M.D., ASSOCIATE DIRECTOR OF MEDICAL 
  CONSULTATION AND REVIEW, OFFICE OF HEALTHCARE INSPECTIONS, 
   OFFICE OF INSPECTOR GENERAL, U.S. DEPARTMENT OF VETERANS 
 AFFAIRS; GEORGE WESLEY, M.D., DIRECTOR, MEDICAL CONSULTATION 
    AND REVIEW, OFFICE OF HEALTHCARE INSPECTIONS, OFFICE OF 
  INSPECTOR GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND 
LIMIN CLEGG, PH.D., DIRECTOR, BIOSTATISTICS DIVISION, OFFICE OF 
   HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR GENERAL, U.S. 
                 DEPARTMENT OF VETERANS AFFAIRS

    Dr. Daigh. Mr. Chairman and Members of the Subcommittee, 
thank you for the opportunity to comment on our findings 
regarding the reprocessing of flexible endoscopes at VA Medical 
Facilities.
    Seated with me at the table are Drs. Herbers, Wesley, and 
Clegg, as you have previously identified. There should be two 
handouts at your tables with the diagrams which I will refer to 
as I go through my testimony.
    Mr. Filner. Dr. Daigh, could you speak more directly into 
the microphone?
    Dr. Daigh. Yes, sir.
    Mr. Filner. It is a hard room to hear everybody. Thank you.
    Dr. Daigh. There are two handouts at your table which I 
will refer to.
    As I present our findings to you this morning, I report 
based on our ongoing work, that VA provides veterans with high 
quality medical care; however, I am concerned that the 
necessary controls are not in place to ensure the consistent 
delivery of a uniform medical benefit to veterans.
    The Inspector General was asked to review the circumstances 
surrounding fiberoptic endoscope reprocessing errors at three 
VA medical facilities; Murfreesboro, Tennessee; Miami, Florida; 
and Augusta, Georgia.
    At Murfreesboro on December 1, 2008 during the colonoscopic 
evaluation of the third and last patient of the day a 
discoloration was noted in the auxiliary water tube, a finding 
that suggests that colonic contents had refluxed into tubing 
connected to the endoscope and thus created a risk of patient 
cross contamination.
    A detailed review of this issue at Murfreesboro was 
undertaken which revealed one, that the one-way valve between 
the auxiliary water tube and the irrigation tube had been 
replaced by a similar appearing connector with no one-way 
valve. Secondly, that the auxiliary water tube was not 
reprocessed between each patient, but at the end of the day. 
And thirdly, that the irrigation tube was not discarded at the 
end of each day.
    On January 7th, 2009, the second and third patient from the 
December 1, 2008, schedule were notified of their risk of 
Hepatitis B, Hepatitis C, and HIV. The first patient of the day 
not being at risk of cross contamination was not notified.
    Our review of the medical literature indicates that there 
are no reported cases of HIV transmission by a colonoscope; 
however, there are cases of transmission of Hepatitis B and C 
in the literature.
    Because the date of use for the incorrect connector could 
not be established, letters were sent on February 9th to 6,387 
veterans notifying them of a potential risk of viral 
infections. The action notified affected veterans from the date 
the endoscope was placed in service, April 23, 2003, who were 
not the first patient of the day.
    After the events at Murfreesboro, a National Center for 
Patient Safety Alert was issued on December 22nd, 2008, 
requiring a compliance, noncompliance response by January 7, 
2009, from VA medical centers. Sixteen additional sites 
reported noncompliance with this alert. Thirteen indicated they 
did not comply with the manufacturer's recommendation for 
change in the auxiliary water tubing between patients, and ten 
indicated noncompliance with changing the irrigation tubing at 
the end of the day.
    As a result of this data Veterans Health Administration 
(VHA) issued a memorandum, and on February 9, 2009, a directive 
on the use and reprocessing of reusable medical equipment in 
VHA facilities.
    VHA directed that an endoscopy step-up week should take 
place the week of March 8 to 14 to ensure compliance with these 
directives.
    I will now address the issues at Miami, Florida. On January 
5th, 2009, Miami responded to the National Center for Patient 
Safety Alert 0907 indicating no problems with endoscopy 
equipment. In preparation for the step-up week it was 
determined that Miami was not compliant with the patient safety 
alert and directives.
    On March 5th, 2009, the VISN was notified, and on March 6th 
the memorandum was forwarded to the VA Central Office (VACO) 
indicating noncompliance with alert.
    The findings at Miami included the auxiliary water tube was 
not processed between patients, none of the irrigation tubing 
had been changed since purchase, and endoscopic procedures 
began before the auxiliary water tube was connected to the 
scope half of the time. This breach of operational protocol 
made reflux of colonic contents into the auxiliary water tube 
more likely.
    On March 17, 2009, VHA recommended disclosure of the risk 
of viral infection to the affected veterans who had a procedure 
between May of 2004 and February 12, 2009. Three thousand two 
hundred and sixty letters were mailed to veterans at risk of 
viral infection.
    With respect to the 16 sites that indicated failure to 
comply with manufacturer's instruction for reprocessing of the 
auxiliary water tube and/or replacement of the irrigation tube, 
VHA determined after a significant review that the risk of 
infection was small, and when balanced against the risk that 
veterans would forego colonoscopic examinations or experience 
other untoward effects, decided not to notify veterans exposed 
to this risk.
    I will now discuss the issues at Augusta, Georgia, VAMC, 
which did not properly reprocess endoscopes used by ear, nose, 
and throat (ENT) physicians.
    On November 4, 2008, after an endoscopic procedure a 
patient questioned why the scope was cleaned with a disposable 
sanitizing cloth when the box indicated that the cloth should 
not be used on equipment that comes into contact with mucus 
membranes? A facility investigation ensued. It was determined 
that ears, nose and throat endoscopes were not properly 
reprocessed and 1,069 affected patients were notified of their 
possible exposure to Hepatitis B, C, and HIV.
    On May 13 and 14, the Office of Inspector General's Office 
conducted an unannounced inspection of colonoscopy and ENT 
reprocessing sites within VA medical facilities testing 
compliance with the VHA directive.
    From the sampling of colonoscopy reprocessing units, the 
OIG projects that nationwide 78 percent of VA colonoscope 
reprocessing units were in compliance with directives by having 
a scope specific reprocessing SOP available at the reprocessing 
site. We estimate that only about one out of two colonoscope 
reprocessing units were in compliance with the requirement to 
ensure demonstrated competency and endoscope processing by 
employees at these sites, and that 43 percent of the 
reprocessing sites had both demonstrated competencies.
    The OIG report recommends that VA ensure compliance with 
the relevant directives regarding endoscope reprocessing, 
explore possibilities for improving the reliability of 
endoscope reprocessing with VA and non-VA experts, and review 
the VHA organizational structure and make the necessary changes 
to implement quality controls and ensure compliance with 
directives.
    VHA concurred with the recommendations and findings and 
agreed to supply us with an action plan.
    Thank you, Mr. Chairman for the opportunity to testify 
before you this morning, we will be pleased to take your 
questions.
    [The prepared statement of Dr. Daigh and referenced slides, 
appear on p. 51.]
    Mr. Mitchell. Thank you, Dr. Daigh.
    You know, one of the most important questions on everyone's 
mind is how do we make sure this doesn't happen again? We have 
seen the procedures were not followed at separate locations.
    And there are two questions I have. Is there something 
about the VA's guidelines and procedures that make them 
difficult to follow in this instance? And secondly, if not, why 
was there a breakdown in procedures at different locations?
    Dr. Daigh. I think that there are a number of different 
types of processes that occur in a hospital. Some require a 
great deal of thought and intellectual activity to derive what 
the treatment plan should be, other processes are really 
industrial in nature. That is, you need to supply reprocessed 
equipment to the right user when he needs that equipment, you 
need to provide sterile equipment to the operating room on 
time. And I think VA needs to take the approach that would 
ensure a tighter quality control methodology and a standard way 
to reprocess these scopes across the entire VA so that there 
are checks in place, people understand exactly who is 
responsible for reprocessing endoscopes at the VA facility.
    For instance, when you look at gastrointestinal (GI) scopes 
and you ask the question who is responsible for reprocessing 
it? We found that in some hospitals it was supply, processing, 
and distribution (SPD), some hospitals it was the nurses in the 
GI lab, some hospitals it was GI lab staff.
    So I think VA needs to standardize the way they deal with 
reprocessing issues, and they need to ensure that there is one 
way to do it and that that methodology is tested rigorously 
during the reprocessing activities by the facilities.
    Mr. Mitchell. Another question. How could the confusion 
between the one-way valve and connector lead to the problems at 
Murfreesboro had been prevented?
    Dr. Daigh. I don't think it was ever determined how the 
one-way valve switch occurred, so that despite a number of 
reviews by VHA, no one understands right now how that occurred. 
The Clinical Risk Assessment Advisory Board (CRAAB) came to the 
conclusion that this was the only instance in which this event 
occurred across the system. We have talked with the 
manufacturer and they are aware of no other instances that this 
has occurred.
    So the best that we can surmise is that in the cleaning 
process at one point in time somebody took apart the tubes and 
then reassembled them incorrectly. The instructions do not 
anticipate that you are going to take these tubes apart and 
remove the valves from the tubes they come assembled with, but 
that is the best guess as to what happened. But there is no 
real known answer to that question.
    Mr. Mitchell. With all the notifications to medical centers 
from scope manufacturers to VA patient safety and directives 
from the VA leadership, why do you think you found such poor 
compliance in these directives?
    Dr. Daigh. If an alert goes out on a topic then I think it 
is important that the individual at each hospital or VISN 
understand clearly who is supposed to respond to that alert. 
And if the management of GI endoscopes at the different 
facilities is actually managed by different people, then I 
think there in fact might be some misunderstanding or confusion 
as to who exactly is supposed to respond to the alert and 
ensure that the alert is acted upon properly.
    I also would point out that the VISNs are all structured 
differently and that the facilities are all structured 
internally differently. And when we were here talking about 
Marion I also made the point that I thought that the committee 
structure within the facility at Marion was not typical of 
other VA facilities.
    So I think the VA needs to think about the flow of data 
through the system, both the quality assurance data, quality 
control data that should routinely be collected at the 
facility, so that it is collected in a standard way, analyzed 
in a standard way, and then reported back to Central Office in 
a standard way. And I think without that it is going to be very 
difficult to solve these problems.
    Mr. Mitchell. Thank you.
    And at this time I would like to call on Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    First of all, I think we should acknowledge that the VA in 
Murfreesboro and Augusta did self-report this, and they are to 
be praised for that. And one of things you don't want to do is 
discourage that by the impunity at the level right there where 
the people had discovered it and found out.
    I will tell you, having been in the operating room 
thousands of times myself, that if this has been an airplane 
taking off or one in the air this would have crashed. That is 
how bad this is. This should not have happened.
    And one of the things you can do I think, Dr. Daigh, is--
and you are familiar with this in the operating room--is a 
surgical pause that we do prior to operating on anybody. Is 
this the right patient? Are we doing the right procedure? Are 
we following the protocol? And do we have the equipment we need 
to do this operation? And I think had the protocols been 
followed--and I was baffled--I have read that entire brief two 
times, and cannot figure out how this happened. How you could 
have had a procedure set in place and just not followed it. I 
mean, I have done literally thousands of procedures, and this 
was just not done right.
    To re-emphasize, I have reviewed the literature myself and 
the incidence of the chances of developing something are very 
remote; one in 1.8 million, probably less than that, but there 
have been reported cases that it has happened.
    And so I agree with Ranking Member Buyer, that you have to 
err on the side of the patient because of the mistakes that 
were made here.
    And I think I would like to know exactly why we did any 
more procedures when we found that we had been doing them 
wrong? Why we didn't stop right then and make sure systemwide--
I realize it is a huge system, 142 or more hospitals--but one 
patient gets harmed, that is one too many. It is 100 percent.
    Can you assure me right now--and I agree with Congressman 
Meek, we need to know--that if I am a veteran, which I am, and 
I go into a VA hospital, do I have confidence in that facility? 
Because that is what is at risk right here, what we are talking 
about. You assure me right now that if I go in and get a 
colonoscopy at Mountain Home VA in Johnson City, Tennessee, 
where I live that it is going to be done properly and that the 
protocols and procedures are going to be followed.
    Dr. Daigh. Well, sir, I am going to ask VA to give that 
assurance. We have recently published a report, we have 
indicated that we think there are systemic issues, and I am 
going to ask that the VA itself offer that assurance to you.
    We believe in check and verify, and so I am not in a 
position to comment on that. I hope that they are in that 
position, but I will ask VA to comment on that, sir.
    Mr. Roe. Is anyone in the panel here able to comment on 
that?
    Dr. Daigh. No, sir. It would be the next panel.
    Mr. Roe. We will ask later when the VA is here.
    I think that one of the things that is sort of surprising 
and was a good thing I think was the recognition at the 
Murfreesboro VA, and all of them that went ahead and recognized 
right then.
    But this, as Congressman Buyer also pointed out, may be 
more systemic than we had first thought, and we need to look at 
every procedure that anyone has and make sure those protocols 
are being followed. Do you all have any recommendation other 
than just follow the protocols?
    Dr. Daigh. I think that for the endoscopy procedures, which 
are in fact incredibly sophisticated equipment used in many, 
many places in the hospital appropriately, that VA work with 
the Food and Drug Administration (FDA) who deals with the 
design requirements and also deals with the instructions to 
clean and properly reprocess this equipment, to see if 
alignment between the hospital's needs to reprocess and to 
efficiently deal with these pieces of equipment can be aligned 
with FDA's requirements. So I think that is an important link 
that needs to occur. And I do know that VHA has been talking 
with FDA on these issues.
    Mr. Roe. Well let me suggest, and I know you are not the 
one, and I am just--I had a colonoscope--it isn't that 
complicated.
    Dr. Daigh. Right.
    Mr. Roe. I mean, it is really labeled four things. It is 
not a complicated procedure. If you follow it, it is one, two, 
three, four. It isn't hard.
    Dr. Daigh. Right.
    Mr. Roe. It is not rocket science.
    Dr. Daigh. Right.
    Mr. Roe. So I think this is something that we have got to 
make sure that we do across this great system. It is a 
wonderful system the VA is, and as Congresswoman Brown said, we 
have had a great increase in the last 2 budget years for VA.
    So I will yield back, Mr. Chairman.
    Mr. Mitchell. Thank you. Mr. Filner.
    Mr. Filner. Thank you, Mr. Chairman. It is nice to hear 
some of the expertise that you have in the operating room 
coming out here. I appreciate that, Dr. Roe.
    Dr. Daigh, How long have you been in your present position?
    Dr. Daigh. I have been in this position since 2003.
    Mr. Filner. Okay. So you have done a series of these kinds 
of investigations.
    Dr. Daigh. Yes, sir, we have done reports on the VA for a 
number of years.
    Mr. Filner. In your experience, has the VA taken all of the 
recommendations that you make in a report? Do you see an 
aggressive response?
    Dr. Daigh. I would say that we work very hard to work with 
the management of VHA to arrive at recommendations that are 
implementable and that from my side of the aisle don't overstep 
by bounds. The manager has to make decisions about how to 
actually decide what to do, and I am not in a position to make 
those positions. But we work hard to drive change for the 
benefit of veterans.
    There are occasions where we find issues that we think are 
extremely egregious where VA has agreed to make a change, and 
so we then have an unannounced inspection and go see if in fact 
they have done what it is they say that they will do. It is not 
a common event, I haven't felt it to be needed on a common 
basis, but every year once or twice we make an unannounced 
inspection. Most of our inspections we look for compliance with 
VHA policy and directives.
    Mr. Filner. How about personnel accountability, have you 
seen any of that in your 5 years?
    Dr. Daigh. I have seen personnel accountability. If you go 
back and look at institutions where we found significant 
defects, either where we felt the quality assurance program at 
the hospital was woefully inadequate. If you go back and look 
at those hospitals you will find that the leadership has in 
fact changed over time at those hospitals.
    So I have seen VA take these issues seriously, and I have 
seen actions taken. And again, I focus on one very small part 
of an individual's job performance, and so it is difficult for 
me to comment more than to say that I have seen significant 
actions taken.
    Mr. Filner. Have those changes been made public in the 
past?
    Dr. Daigh. I am uncertain of that.
    Mr. Filner. I mean as Congressman Meek said firing somebody 
doesn't necessarily change the situation, but I think 
disciplinary action is a part of accountability, and as the 
French would say it is to encourage the others to make sure 
that they realize how serious it has been.
    I have been on the Committee for 17 years and I haven't 
heard a public response to any problem that there is a specific 
disciplinary change. Maybe they just don't make it public.
    As I said earlier, I think that is going to change. The 
Secretary has assured me of that. As I said earlier, once the 
legal requirements are followed that there is some public 
announcement of the changes that are made due to this incident. 
Dr. Roe said that he can't understand how it happened. I think 
that is helpful quite frankly, and I think it is long overdue.
    There is a sense that this big bureaucracy of 250,000 
people somehow doesn't have to worry about following these 
procedures to the letter.
    We will talk to the VA panel when they get here, but I 
think you will see a different situation.
    Most of the Members here have said that we appreciate what 
you do. We have had discussions and I hope that we have tried 
to increase your budget, increase your ability to be effective, 
and that is an important part of the checks and balances that 
we have to have.
    I thank you for your work and look forward to a new era of 
transparency and accountability.
    And I thank the Chair.
    Mr. Mitchell. Thank you. Mr. Buyer.
    Mr. Buyer. Thank you very much.
    I feel somewhat disadvantaged here today, and so I will 
have follow on with you at another day. Disadvantaged in that 
this is the first time I have had a chance to see your report 
is right now, and so I am going to take a chance to digest 
this, to learn it, and get some greater understanding. But I do 
have a couple of questions I will ask.
    And that is first, let me thank you with regard to your 
methodology. I do like the fact that you expanded this, that 
you then sought to do a random sample, and then to use the 
probability to help forecast. So your methodology I think is 
sound. I like the fact that you took that type of an approach. 
And I love the fact that you did these unannounced on site 
visits. I am sure it really was very upsetting to many people 
that you did such a thing unannounced especially, and I am sure 
there were tremendous repercussions from things like that. And 
they are not fun, they are not easy, and so let me thank all of 
you.
    A real subjective question I want to ask you is, are you 
comfortable that you have an understanding of the scope of the 
problem? Too often we are eager to run out for solutions, but 
do you believe we understand the scope of the problem?
    Dr. Daigh. I think that the problem of the endoscopes is 
extremely important, but I think that the bigger problem is 
again the implementation of industrial process management where 
appropriate within VHA facilities, the determination of what 
data should be collected at facilities, and then how it should 
be reviewed at facilities, and a review of the reporting 
requirements and checks and balances from the facilities to VA. 
So if that answers your question.
    Mr. Buyer. I guess for the motivation of my question is, 
when I went to this report, the Administrative Investigative 
Board at Miami. Now under one of the conclusions on the 
endoscope, if we want to focus just on this, the reason I am 
asking do we really understand the scope of the problem is 
going to be twofold.
    Here they sought then to follow the instructions and the 
guidelines and they believed that what they had was now clean. 
So on March 26th, 2009, during a demonstration by an Olympus 
representative debris was discovered when manually flushing one 
of the channels of a clean scope.
    Dr. Daigh. Right, that is very disconcerting.
    Mr. Buyer. So that is why I am saying, you know, we can say 
okay are they following the process and the procedures? If they 
followed the process and the procedures and they believed it 
was clean and when in fact it wasn't clean.
    So is there going to be more out there that we are not 
thinking of? Okay? Hold that, hold that.
    And here is the other reason I asked that question. The 
pump that is used for this is also used--can be used in the 
ENT. You can have a situation whereby the pump that can also 
have been found to have debris, that very same pump used for a 
colonoscopy could then be used as an endoscope, could it not?
    Dr. Daigh. I am uncertain of the answer to that. I am 
saying that I don't know the answer to that.
    Mr. Buyer. Well you should not, but it is possible that the 
very same pump could be used with both, correct?
    Dr. Daigh. I think so, yes.
    Mr. Buyer. Yes. And so if we have got a process whereby 
rules and procedures are not being followed, we have a very low 
competency rate that you in fact are showing us, now I kick it 
back to you relative to the scope of the challenge that is in 
front of us. I didn't mean to use the word scope.
    Dr. Daigh. Well we would recognize that there are again 
many endoscopes, and every doctor that doesn't have one would 
like one, and they are used in many parts of the hospital. So 
we focused on colonoscopes and ENT scopes because that was the 
issue we were addressing.
    But I think again, in the reprocessing of all of these 
scopes people need to think carefully about how they are going 
to do it, manage the process, and ensure it is done well. And I 
think that needs considerable thought and review within VHA. I 
think there should be a VA way to do it with assigned clear 
responsibility and clear measurement to ensure that that is 
occurring. Right now I think it is done differently at 
different places, under different individuals responsibility 
and control, with individuals with different level of training, 
some people reading the manual and going exactly step by step, 
some people going by how they remembered they used to do it, 
even though the scope has changed and now has a biopsy port, 
now has an auxiliary water channel, now has some other feature 
that is going to occur next year. So there needs to be 
inculcated into the VA hospitals a VA way to do this.
    Mr. Buyer. Mr. Chairman, I know my time has expired, but 
may I ask this?
    Is there a specific rule that a pump that is used for GI, 
that pump is never taken out of that room and shared by any 
other operating room in that hospital? Are there specific rules 
that say that?
    Dr. Daigh. I am unaware of those kind of restrictions on 
equipment where I have worked. Usually the equipment is 
reprocessed and then used wherever appropriate. So you would 
expect that wherever you did--you could do a colonoscopy in 
many different places. You could do it in a GI suite, you could 
do it in the operating room, you would expect that the 
equipment was appropriately presented to you in the right 
status no matter where you were so the operator shouldn't worry 
about that the equipment is in the right condition.
    Mr. Buyer. I guess I am trying to nail this down. Would the 
pump that is used for this colonoscopy ever be used as an 
endoscope?
    Dr. Daigh. I will have to take that----
    Mr. Buyer. We don't know?
    Dr. Daigh. I would have to take that for the record. I 
don't know, sir. Whether the pump that drives that water could 
be used in another I don't know the answer to that.
    [The information was provided in a followup letter from the 
VA OIG, dated July 23, 2009, which appears on p. 63.]
    Mr. Buyer. Thank you.
    Mr. Mitchell. Mr. Walz.
    Mr. Walz. Well, thank you again, Mr. Chairman, and thank 
you to your whole team here from the IG. As I said, I see you 
as partners in quality and oversight and I truly appreciate 
that. And as other Members have expressed, to think that--not 
because I want to find somebody doing something wrong--
unannounced visits are the best way or one of the ways to help 
ensure quality, but not the only way, and obviously it is 
procedures we are trying to get at.
    A couple things I want to ask. When I saw your report, you 
said, ``Appropriate endoscope SOPs were available 78 percent of 
the time, proper training 50 percent of the time, and compliant 
with recommendations 43 percent of the time.'' Does that 
trouble you, or am I thinking that I could extrapolate that to 
other procedures as being a problem if the SOP are not even 
available, let alone being trained and followed? Can you help 
me understand that? Would that trouble you?
    Dr. Daigh. Yes, sir, it troubles me greatly, we looked at 
ENT and we looked at GI, so that----
    Mr. Walz. You know, and I know we have a lot of work to do 
on this, this of all the things is troubling. Of course, you 
know, when I see when we are trying to figure out the risk of 
probabilities I know we talk about things like adverse events.
    Going in for a routine colonoscopy and being contacted 
later that you are HIV positive or Hepatitis C is not just an 
adverse event, that is absolutely catastrophic.
    So a couple things I would like to get at. Maybe some of 
you can help me with this and I can't track it down, I 
apologize. The staff has been looking at this. Did this happen 
back in the 1990s at the Houston VA? Do some of you recall 
that? I know you didn't prepare for this.
    Dr. Daigh. My memory doesn't go back that far, sir. Maybe 
on the next panel they might be able to answer that.
    Mr. Walz. Okay. We will check and see on this.
    Two other points I have, and this is one. Olympus, the 
manufacturer of the one we are talking about in question here, 
are they required or do they provide routine in-service 
training for people on this, or is that solely the 
responsibility of the VA then? Do you know?
    Dr. Daigh. I believe that when you purchase equipment they 
will certainly come and train, and it is clear from the sites 
that we visited that Olympus folks have been on site helping to 
train individuals. So the manufacturers I believe are willing 
and able to train folks on how to properly reprocess their 
equipment.
    Mr. Walz. And I know you weren't looking at them, but it 
was part of it. You think the manufacturers are a resource that 
could definitely be used on how to do this correctly and just 
might not have been?
    Dr. Daigh. I will strongly agree that the manufacturers are 
a resource that are willing and can be used, and I am uncertain 
to what extent they were used at each of these sites.
    Mr. Walz. Okay.
    Dr. Daigh. But clearly they were on site at some of these 
places.
    Mr. Walz. I see the staff just gave me a letter from the 
Olympus company, and again, I will say the same as the Ranking 
Member said, there is more to read on this and to hear, I am 
just trying to get at the systemic problem on this.
    I thought an interesting point was brought up, and I know 
you may not have the statistics and something we need to find 
on this. How often are these types of mistakes made in the 
private sector? Do you know of any other----
    Dr. Daigh. We tried very hard to get data, but there is no 
data that I am aware of, nor could I get other than rumor, and 
I really can't report rumors, so I don't have an answer to that 
question.
    Mr. Walz. I know some of us who are concerned about this 
see that as a short fall right now. And definitely again, I am 
agreeing often with the Ranking Member. I don't know, it is in 
the air today, or it could be he is absolutely right on this, 
and as often, but this issue of seeing if this is a systemic 
problem, Mr. Buyer, I think you were at this that we have a 
great potential here--what the IG has done and what VA is doing 
to focus on what could be a greater problem in the private 
sector.
    Mr. Buyer. Would the gentleman yield?
    Mr. Walz. Yes.
    Mr. Buyer. You are right on the cusp when we talked about 
manufacturers. How many manufacturers are there?
    Dr. Daigh. Five.
    Mr. Buyer. Five? And of those five manufacturers when the 
Sergeant Major brought up the SOPs are they different for each 
manufacturer with regard to reprocessing?
    Dr. Daigh. Well, I think that there is a--each scope comes 
with a cleaning instruction, so the answer is there is going to 
be a specific cleaning instruction for each scope.
    Mr. Buyer. How about that. You were right on it.
    Mr. Walz. Yeah. And it is just the enlisted guy in me 
always wants to find a conflict point there with the officer. 
But no, I appreciate it, my time is coming.
    Again, we have much to ask for the next panel, but I can't 
express my deep appreciation enough as I have spoken many times 
for what the IG is doing as partners in this. We have always 
seen you as that. I know the VA sees you as that, and that is 
the way they need to see you. If there is friction there that I 
know some would see that better go away fast, because this is 
all about preventing this from happening in the future and care 
for your veterans, and that is where we go forward.
    So I yield back, Mr. Chairman.
    Mr. Mitchell. Thank you. Ms. Ros-Lehtinen.
    Ms. Ros-Lehtinen. Thank you. Thank you so much, Mr. 
Chairman again for the time, and thank you to the Ranking 
Members as well. Thank you for an excellent report.
    I had a question on the timeline and how often this 
timeline is replicated in other problems that you have 
explored, is this normal procedure, the kind of lag in time?
    February 2003 Olympus issues a safety alert. February 2004, 
a year later, the VA issues an alert. And then February 2009, 
many years later, VA does that push week where everybody is 
really going to look at their equipment after they have been 
told everything is fine. And then in March of 2009 is when the 
Miami VA reports the problem with water supply tube.
    That is a long time that each one of these actions has 
taken. Is that normal for medical equipment in VA facilities? 
Does this one seem to take a lot longer to have folks pay 
attention, or is this just the way the system works?
    Dr. Daigh. I would say that the length of time in terms of 
the way we found VA to perform is not normal for what I see, 
and that the cleaning and reprocessing of these scopes is in 
fact a rather rigorous, boring job that is repetitively done 
many, many times a day where you do high volumes of these, that 
I think until it is treated as an industrial process with those 
kind of quality control and performance measures in place there 
will not be the prevention of episodes like this.
    The scopes are going to continue to evolve. What you did 
yesterday to clean it will change when the scope is modified.
    So I think it is that they need to treat this and some 
other processes that are similar in the hospital as industrial 
processes and put those criteria in place.
    Ms. Ros-Lehtinen. And I like the three recommendations that 
you make, and certainly I think one of them should be that 
these safety alerts and that these notices from the Central VA 
need to be paid attention to, because it seemed like it was 
just another e-mail and another letter in the mail, and there 
was so much time that went by where they could have caught this 
and stopped it, but either their routine or----
    Dr. Daigh. Well, let me comment.
    Ms. Ros-Lehtinen [continuing]. They are not treated as 
seriously as they should.
    Dr. Daigh. I believe that they are usually treated 
seriously.
    A couple a years ago there was an alert that indicated that 
a manufacturer was using--I guess they were cadaver parts--and 
that those parts used for surgeries were not properly being 
harvested and they might have the risk of illness. So 
similarly, we did an unannounced check. The alert went out from 
patient safety that there was a problem. We did an unannounced 
check of facilities to see whether or not there was compliance, 
and VHA had complied very well with that. Our report had some 
minor issues about the management of that data and did they 
have it and where we thought the right place should be, but we 
checked the patient safety alert and they did well.
    So I was somewhat surprised at the noncompliance we found 
here, because when I looked before I had seen things to be much 
better, but when you think about the process that is trying to 
occur, I think it is a process.
    Ms. Ros-Lehtinen. And just one last question----
    Dr. Daigh. Yes, ma'am.
    Ms. Ros-Lehtinen [continuing]. Because I know my time is 
up.
    About the inventory. The chief of SPD stated that there was 
no auxiliary water tubing equipment at the Miami VA and then 
they found out that there was. And I was wondering how normal 
it is and par for the course that the inventory could be so 
haphazard and staffers don't know this equipment that they are 
overseeing? How good is the inventory in our VA clinics?
    Dr. Daigh. That is normally looked at by audit, but there 
was a Core Financial and Logistics System (FLS) project that 
occurred some years ago where people were trying to get 
inventories and business processes inline, and I think that 
from--again, I would have to defer to our audit group--but I 
think there are some problems with inventories and keeping the 
inventories up to date and maintaining them as tightly as you 
would like and expect them to be. So I think there are issues 
with that. Both with supplies and other issues too.
    Ms. Ros-Lehtinen. Thank you. Thank you, again. Thank you.
    Mr. Mitchell. Mr. Meek.
    Mr. Meek. Thank you again, Mr. Chairman.
    Dr. Daigh, I want to, and I know at the beginning of your 
report you say, that you were activated not only by the 
Chairman of this Committee, but also oversight bodies within 
Congress and Members of Congress, me being I am pretty sure one 
of the first, if not the first to write you and bring this to 
your attention of what happened at the Miami VA to get you and 
your team in yesterday to start looking at these issues.
    I know at the beginning of the report many times of your 
years of being at the VA and reporting what your findings are 
and started out the report, ``Suspected wrong doing in VA 
programs and operations.'' I think, you know, we are beyond 
suspected, we do know that they were not carried out.
    Some of the findings that Ms. Ros-Lehtinen and others have 
pointed out of the three, we are asking the VA to implement, 
starts at the Under Secretary or the Assistant Secretary level, 
acting Under Secretary in this case, to really deal with the 
issue as to endoscope and other scopes throughout the VA to 
assure that procedures are improved and responsibility is 
paramount when it comes down to this very boring process that 
you talk about of making sure that these machines are sterile.
    Definitely, in my opinion, rise to the Secretary level. You 
know, the Secretary being fully aware of what is going on and 
that the management that is in place as the Ranking Member Roe 
has said, that when a veteran walks into the VA--I mean you 
used the term ``check and verify,'' that is what you do, you 
don't necessarily implement or assure.
    I mean, you are going to, I understand from this report, a 
detailed report is supposed to be given I guess by the VA in 
July of 2009 coming up and then you are going to continue to 
follow up on that report to make sure that things--so I guess 
you are going to continue to do your surprise inspections, your 
team will be out there, what the VA tells you what they are 
doing and how they are doing it you are going to verify that.
    Because I can tell you just as a Member of Congress that 
have sat down with veterans that were a part of the Miami group 
that emotionally sat in my office more concerned about their 
family. We are talking about veterans, we have to also talk 
about significant others who felt that they could possibly be 
compromised. And it is a very long 7 days from being tested and 
being cleared that goes on in a veterans home. Because the 
veterans are not over it yet. They have to be retested in 
months to come.
    So I see this as a very Secretary or I would even put it as 
high as the President, should be very, very concerned about 
something that I don't want to be over alarming here that have 
been identified as a very small chance that something could 
be--a life-threatening disease could be transferred because 
they went through this procedure, but the possibility exists 
regarding of the personal responsibility that the veteran he or 
she has taken on to make sure that they don't infect their 
family members with any of the Hepatitis, HIV, or any of the 
transmitted diseases that can be transmitted through this 
procedure and other acts of lack of responsibility.
    The lack of responsibility has fallen on the VA, and this 
is a bipartisan spirit I know in the Congress in making sure 
that this doesn't happen. I want to ask you how do you feel 
about the level of concern that the VA has based on your report 
and their own findings?
    Dr. Daigh. I would say that I have briefed Dr. Cross and I 
have briefed the Secretary on this issue. I have talked with 
other senior VA managers, some of whom will be testifying here. 
There is no one who hasn't taken this extremely seriously. And 
I believe that they will make the changes required to ensure 
that this does not occur or is much less likely to occur in the 
future.
    It is very difficult to give on a complex process with 
complex equipment that there will never be someone who doesn't 
reprocess it incorrectly and raise their hand and say I have a 
problem we need to deal with it. But I think that the 
appropriate changes will be made to do everything humanly 
possible to ensure that the risk is as close to zero as we can 
make it.
    Mr. Meek. So on the scale of the response that you have 
received from the VA and the briefings that you have been a 
part of obviously you have had a sit down with the Secretary 
prior to sharing with us here in this Committee of some of your 
findings.
    Dr. Daigh. That is correct.
    Mr. Meek. How do you feel from a scale of one to ten of the 
response or the confidence that you have? Obviously you are 
going to check regardless if they are being followed through. 
It is one thing for us to say something in Washington, it is 
another thing in Tennessee or Georgia or a VA clinic--we even 
break this down to a clinic because it is not all hospitals--
following that procedure and making sure that the proper 
management is in place. Because as far as I am concerned, the 
button should have been pressed long ago. We have been told in 
Congress and I don't know how many times we have been told that 
it is being followed to only find out in your report that it 
was dropped this morning at 6:00 a.m. that it has not been 
followed. And I mean, where does it stop and where does it 
begin? The healing begin.
    And I just want to, you know, I think I have been very 
patient and a number of other Members have been patient, Mr. 
Chairman, as I close, have been patient with the VA as it 
relates to this issue.
    And so I came today with the very different attitude than I 
have had in the past of hope and change as it relates to the 
seriousness of this situation, and for it to be resolved. You 
are part of the solution. You know, your office is part of the 
solution in reporting and doing what you are supposed to do, 
Congressionally and statutorily.
    But I want to make sure that the VA has the proper not only 
heat but motivation of knowing that the very best should be on 
this particular subject, because when we lose--when the veteran 
loses confidence in the VA, then we have all failed them 
regardless of who is responsible and who is not responsible.
    So thank you, Mr. Chairman, I look forward to hearing from 
the next panel.
    Mr. Filner. Mr. Chairman, would you just yield for a 
second?
    Mr. Meek, I know you are talking to the Inspector General, 
but as the full Committee Chair I have discussed this with the 
Secretary and his deputies, and I can assure you that I have 
been pretty bulldoggish in my attempts to get accountability, 
and I am convinced on your scale of one to ten that it is ten 
in terms of understanding the seriousness and acting quickly to 
deal with it.
    Mr. Buyer. Mr. Meek, will you yield?
    Mr. Meek. Yes.
    Mr. Buyer. Mr. Meek, you were right on the point.
    Here is where I see the real problem, Mr. Chairman. Is this 
has come out into the public, we know the problem is in three 
locations, the VA should know that there is a problem out 
there, yet he goes and does an unannounced inspection at 42 
sites and finds out that leadership has not occurred at the 
medical centers.
    Mr. Meek, you are voicing the concern for all three of you, 
but it is beyond the three of you. And what I can't get at, and 
there is a leadership challenge here and we will get into this 
in the next panel, but this is already in the public. Your 
competency level should not be this low; these percentages. 
They should be higher. Because they have been given notice that 
there is a problem, yet where was the leadership?
    So Mr. Meek, I congratulate you for your line of 
questioning.
    Mr. Mitchell. Mr. Broun.
    Mr. Broun. Mr. Chairman, thank you so much for the ability 
to come and participate with this hearing, and I agree with 
Congressman Buyer, that I am very distressed about the 
competence level that we have across the board in this system. 
As a physician I am very concerned about it.
    And Dr. Daigh, I want to ask a question. There seems to be 
some confusion with my constituents in Georgia in the 10th 
Congressional District about the timeline of events of the 
occurrences at the Charlie Norwood VA Center there in Augusta. 
And I was wondering if you could clean up the timeline for us. 
When did the facility become aware of the endoscopy 
sterilization problem? Was it in April or November of 2008 or 
was it some other time?
    Dr. Daigh. It was November 2008, yes.
    Mr. Broun. Well are you all aware of e-mails that were 
discussing an endoscopy sterilization issue in Augusta as early 
as April of 2008?
    Dr. Herbers. I will speak to that briefly.
    Sir, after this was brought to our attention and of course 
after it was brought to the attention of the leadership at 
Augusta there was a look back and it was discovered that in 
fact some individuals locally--had been aware of the problem 
and that it had not been brought to leadership's attention. So 
yes indeed there is evidence that it was known long before 
November.
    Mr. Broun. That is totally unacceptable to me. Why in the 
world was that not brought to the attention of the leadership?
    Dr. Daigh. I don't know the answer to that, sir. Are you 
referring, sir, to the issue of an employee indicating that 
they had gone to a superior and said that these are reprocessed 
at another site differently than reprocessed here?
    Mr. Broun. Well, I am not privy to the e-mails, but it is 
my understanding that there was some e-mail traffic indicating 
that there were some problems. Why wasn't leadership notified 
of that? And why wasn't something done about it earlier?
    Dr. Daigh. We did not pull the e-mails at these sites, sir, 
and I haven't read the e-mails directly. I think if you talk to 
the panel behind me they can more accurately address these 
issues.
    I am aware that one employee indicated that they had 
brought to the attention of individuals at the facility that 
reprocessing wasn't occurring correctly. And then I think it 
becomes a he said she said argument as we understand the facts.
    Mr. Broun. Well, I encourage you to look into that e-mail 
traffic and let us get some answers. Because I think each step 
of the way needs to be dealt with and we need to find out when, 
how, why, all the questions need to be answered across the 
board.
    Dr. Daigh, you mentioned in your testimony that medical 
research has shown that Hepatitis B and C has been transmitted 
through endoscopes. I would like to see those data actually. Is 
the same true for HIV? And how likely is it that if a high 
level of disinfectant was used, as in the case in Augusta, that 
each of these viruses or any of these viruses could be 
transmitted to another patient?
    Dr. Daigh. I believe that if the reprocessing is done 
correctly there is no transmission reported. If the 
reprocessing of endoscopes is done incorrectly then there has 
been transmission of Hepatitis B and C.
    So I will ask Dr. Wesley to bring you up an article that 
cites that.
    Mr. Broun. I would like to see that and we might enter that 
into the record, Mr. Chairman, if that is okay. Okay, very 
good. Thank you for the article. I appreciate that.
    [Two articles were submitted, but will be retained in the 
Committee files. The articles are entitled, ``Gastrointestinal 
Endoscopy Decontamination Failure and the Risk of Transmission 
of Blood-borne Viruses: A Review,'' by J. Morris, G.J. 
Duckworth, and G.L. Ridgway, Journal of Hospital Infection 
(2006) 63, pages 1-13; and ``Transmission of Infection by 
Gastrointestional Endoscopy,'' May 2001, by American Society 
for Gastrointestinal Endoscopy Technology Committee, Technology 
Status Evaluation Report, Gastrointestinal Endoscopy (2001), 
Volume 54, No. 6.]
    But back to my question. It is my understanding in Augusta 
a super strong disinfectant was used in inappropriate ways, it 
was used through wipes instead of through the proper cleaning 
procedure, but I still don't have the answer to the question. 
If this procedure was used with a super disinfectant, what is 
the likelihood of transmission of these three viruses with the 
procedure that was utilized at the Charlie Norwood VA? Do you 
have any data?
    Dr. Daigh. I can't answer that, sir. Someone on the second 
panel might be able to answer that. We did not look at that 
question in detail.
    From our point of view either you reprocessed the endoscope 
appropriately or you did not. If you did not reprocess it 
appropriately, then there is a risk. And so I think that is the 
way VHA has viewed these issues also.
    So I can't answer your question.
    Mr. Broun. Well, I think those data need to be found so 
that the veterans who have been exposed need to know what their 
potential of exposure is.
    Thank you, Mr. Chairman.
    Mr. Mitchell. Thank you. Mr. Space.
    Mr. Space. Thank you, Mr. Chairman, and please accept my 
apologies for arriving late, I have got another hearing running 
simultaneously to this.
    Mr. Daigh, your testimony indicates that the Veterans 
Health Administration conducted a national review in September 
of 2006 which included purportedly as part of that review all 
VHA facilities conducting self-assessments. And my question is, 
given that widespread errors were found by unannounced site 
checks, why was the decision made to conduct self-assessments 
as opposed to bringing in independent third-party evaluators?
    Dr. Daigh. I don't know the answer, sir, you will have to 
ask VHA. That decision was theirs, not mine.
    Mr. Space. Do you have any concerns with the fact that 
self-assessments were utilized in this case given the findings?
    Dr. Daigh. As I have stated, when issues rise to the level 
of a certain threshold, then I don't use self-assessments. I go 
out and inspect and try to get data to make a decision.
    So the answer to that question is yes, I am concerned that 
they use self-assessments, at the same time there are many, 
many issues that need to be addressed and somebody has to make 
a decision about which ones to physically inspect and which 
ones to have people tell you what they did. That would be a VHA 
issue.
    Mr. Space. Sure, and I am not asking that you answer a 
question that is beyond your pay grade, but in this situation 
now do you think the facts would warrant further third-party 
investigations of all VHA facilities given what was found in 
the ones involved here?
    Dr. Daigh. I think what is important to do is to have 
individuals who understand the reprocessing routine who are 
experts in how you actually reprocess the scopes to observe and 
make sure that VHA individuals who do that job do it correctly.
    So what I would have liked to have done is myself sent 
people out and watched people reprocess those, but that is a 
skill that my staff doesn't have and I could not do that on an 
unannounced basis.
    I think that again, VHA may have some views about how that 
might be accomplished or how that should be done, but that is 
what I think should be done.
    Mr. Space. Thank you, Dr. Daigh, I yield back. Thank you, 
Mr. Chairman.
    Mr. Mitchell. Thank you. I want to thank you all for the 
work that you have done, Dr. Daigh and your staff. And before 
we excuse you I would like to ask if there is anyone else that 
is with you at the table that has any other comments or 
suggestions that we haven't covered?
    Dr. Daigh. Sir, I would like to thank you----
    Mr. Mitchell. Yes.
    Mr. Buyer. I just have one last question of you so that I 
have a good understanding.
    There has been so much focus on the tube itself with regard 
to reprocessing. When you went out and you looked at the 42 
different sites, did you sense that when you have such a low 
competency rate on reprocessing that each medical facility was 
sort of across the board? Some may clean the tube but not the 
pump, some may clean the tube and the pump but not the biopsy 
portion. They are to clean all portions after each procedure. 
Did you find everybody was a little bit across the board on 
everything?
    Dr. Herbers. I will try to comment on that, Mr. Buyer. I 
believe our inspectors found a range of findings. But I want to 
make clear that almost every facility had some sort of 
documentations of demonstrated competence on the part of staff. 
We were quite explicit, based on VHA's directives, that 
competence be model and scope specific, because we know it 
matters which scope you are talking about.
    So I guess I just want to make it clear that there was 
evidence of documentation. We are not talking about people 
having no training or no demonstrated competence, but we didn't 
think it rose to the level that it was appropriate.
    Mr. Buyer. I know, but when you say 50 percent or 60 
percent on competency I got this really strange sense that some 
may have cleaned the tube but not the pump, and in Miami they 
even found where the biopsy portion of this instrument was 
found to have debris.
    Dr. Herbers. No, I think the 50 percent does not work that 
way.
    What we are saying is that the individuals who do this 
work, in their training files you could not see that they had 
demonstrated competency to do this job for each scope that they 
owned at that site. So there might be scopes that had water 
channels and some without and there might be scopes from 
different manufacturers. So the instruction was follow the 
manufacturer's guidelines, just clean the scopes. We went out 
to see if in fact these individuals had the demonstrated 
competency to do that in their training records.
    Mr. Buyer. I know, I am just left with a very strong 
feeling though that we could actually have a medical center 
whereby the pump may have been cleaned, the tube may have been 
cleaned, but maybe the biopsy portion was not cleaned until the 
end of the day.
    Dr. Herbers. I can't comment on that.
    Mr. Buyer. You know, and you could very well have that type 
of thing occur and you have got the debris buildup from the 
procedures for the day.
    All right. I yield back. Thank you very much for your 
quality work.
    Mr. Mitchell. Thank you very much, and we appreciate your 
work and your testimony today.
    Dr. Daigh. Thank you, sir, I appreciate your support.
    Mr. Mitchell. At that time we would like to invite the 
second panel to come to the table.
    Mr. Buyer. Mr. Chairman.
    Mr. Mitchell. Yes?
    Mr. Buyer. May I entertain a colloquy with you while we are 
having the second panel set up?
    Mr. Mitchell. Sure.
    Mr. Buyer. Maybe what would be a good idea for thought 
between you and Dr. Roe is that we have a--the IG has set a 
good baseline for us, and that baseline will also be used as 
directives to the leadership in the VA. Since they already have 
a present expertise we ought to keep them online and say okay, 
now we want you to go out, I don't know what your 
recommendation would be on 6 months from now give us a progress 
report.
    Mr. Mitchell. Absolutely.
    Mr. Buyer. I am just curious. I mean, the expertise is 
there, let us just not let it go. This is a maintenance issue 
and leadership issue that we are going to have to continue with 
your oversight.
    Mr. Mitchell. And one of the things that I have asked our 
staff to do is to let the people know, not only this particular 
panel, but any other hearings that we have had to follow up. We 
just don't want to have a hearing and then drop it and not 
follow up.
    Mr. Buyer. Right.
    Mr. Mitchell. So we are going back and those that have made 
suggestions from other hearings we are going to double check on 
it. I think it is the good idea.
    Mr. Roe. Mr. Chairman may I?
    Mr. Mitchell. Yes.
    Mr. Roe. One of the things, that this is a quality of care 
issue that goes at the very heart of what you do in a hospital, 
and you have to have a confidence that it is being done right. 
It is not that complicated. And I am telling you right now, I 
have been in the operating room thousands of times, it is 
mundane and routine, but complicated it isn't. It is making 
sure that scope is clean, that is just simple, like washing 
your hands. You wash that scope, you process it properly, and 
you don't take it for granted. And I think it goes at the very 
heart of what we are and what we do in any hospital, not just 
the VA. Your point was well taken.
    Mr. Buyer. We have done this before with the Joint 
Commission, for example, on a particular issue asking them to 
follow it.
    Mr. Mitchell. Right.
    Mr. Buyer. I would be more than happy to----
    Mr. Mitchell. And I think the VA noticed it that we are 
going to have some more checks just like we had the last one. 
Absolutely.
    Mr. Buyer. Okay. Thank you very much.
    Mr. Mitchell. It does no good to have these hearings if 
there is no followup.
    Mr. Buyer. All right, thank you.
    Can I ask one more?
    Mr. Mitchell. Sure.
    Mr. Buyer. Have you ever considered doing a six sigma 
industrial process on this? Well your next panel is in place. I 
would be more than happy to engage you on this and how we 
proceed.
    Mr. Mitchell. Sure.
    Mr. Buyer. Thank you.
    Mr. Mitchell. I welcome panel two to the witness panel. For 
our second panel we will hear from Dr. William Duncan, 
Associate Deputy Under Secretary for Health for Quality and 
Safety, Veterans Health Administration, U.S. Department of 
Veterans Affairs. Dr. Duncan will be accompanied by Dr. Jim 
Bagian, Chief Patient Safety Office, Veterans Health 
Administration; Nevin Weaver, Director of VISN 8; Lawrence 
Biro, Director of VISN 7; Dr. Joseph Pellechia, Interim Network 
Office Medical Officer and Chief of Staff, Huntington VA 
Medical Center; Dr. John Vara, Chief of Staff, Miami VA 
Healthcare System; Dr. Juan Morales, Director of Tennessee 
Valley Healthcare System; Rebecca Wiley, Director of Charlie 
Norwood VA Medical Center; and Mary Berrocal, Director of Bruce 
W. Carter Veterans Affairs Medical Center.
    I would like to recognize Dr. Duncan up to 5 minutes and 
let him know that all of his statement will be placed into the 
record. Thank you.

 STATEMENT OF WILLIAM E. DUNCAN, M.D., PH.D., MACP, ASSOCIATE 
DEPUTY UNDER SECRETARY FOR HEALTH, QUALITY AND SAFETY, VETERANS 
  HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; 
ACCOMPANIED BY JAMES P. BAGIAN, M.D., PE, CHIEF PATIENT SAFETY 
 OFFICER, NATIONAL CENTER FOR PATIENT SAFETY, VETERANS HEALTH 
  ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; NEVIN 
 WEAVER, FACHE, DIRECTOR, VETERANS AFFAIRS SUNSHINE HEALTHCARE 
     NETWORK, VISN 8, VETERANS HEALTH ADMINISTRATION, U.S. 
  DEPARTMENT OF VETERANS AFFAIRS; LAWRENCE A. BIRO, DIRECTOR, 
  VETERANS AFFAIRS SOUTHEAST NETWORK, VISN 7, VETERANS HEALTH 
  ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; JOSEPH 
 PELLECCHIA, M.D., FACP, INTERIM NETWORK CHIEF MEDICAL OFFICER 
AND CHIEF OF STAFF, HUNTINGTON VETERANS AFFAIRS MEDICAL CENTER, 
  VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS 
 AFFAIRS; JOHN R. VARA, CHIEF OF STAFF, MIAMI VETERANS AFFAIRS 
    HEALTHCARE SYSTEM, VETERANS HEALTH ADMINISTRATION, U.S. 
   DEPARTMENT OF VETERANS AFFAIRS; JUAN A. MORALES, RN, MSN, 
 DIRECTOR, TENNESSEE VALLEY HEALTHCARE SYSTEM, VETERANS HEALTH 
ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; REBECCA J. 
   WILEY, DIRECTOR, CHARLIE NORWOOD VETERANS AFFAIRS MEDICAL 
  CENTER, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF 
VETERANS AFFAIRS; AND MARY BERROCAL, DIRECTOR, BRUCE W. CARTER 
       VETERANS AFFAIRS MEDICAL CENTER, VETERANS HEALTH 
      ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS

    Dr. Duncan. Mr. Chairman and Members of the Subcommittee, 
good morning. Thank you for this opportunity to discuss 
endoscopy procedures at the Department of Veterans Affairs.
    Today I would like to provide you with a brief background 
on endoscopic devices, explain what happened at our facilities, 
describe the changes our Department has instituted, report on 
new national policies, and discuss what will happen in the 
future.
    America's veterans deserve the best possible care at every 
health care facility we operate. VA is widely regarded as among 
the Nation's finest health care providers, but we can never 
rest on our laurels as these events have shown. Mr. Chairman, 
let me begin by explaining what endoscopies are. Endoscopes are 
devices small in diameter which allow physicians to see 
patients internal organs through external orifices using a 
system of optics.
    Colonoscopes, which are the type of endoscopes used in 
colonoscopies, sometimes have an internal tube that allows the 
physician to inject a stream of water through the scope to 
flush away any material that might obstruct their ability to 
see properly inside the colon.
    Endoscopes are complex, reusable, medical instruments that 
need to be thoroughly cleaned or reprocessed before they can be 
used more than once.
    Endoscope manufacturers specify the type of reprocessing 
procedures that must be used on the equipment that they 
manufacture. Generally these procedures involve careful 
cleaning of the entire external and internal surfaces with an 
appropriate cleaner, brushing away debris on any interior 
channels, and providing the entire scope with high level 
disinfection or sterilization.
    Since December 2008, 30 VA medical centers have reported to 
us that they have not been reprocessing the endoscopes they 
use, or the water flushing system used with the endoscope in 
accordance with the instructions of the manufacturer.
    We rigorously studied the circumstances at each site. We 
determined that for four VA medical centers, Murfreesboro in 
Tennessee; Augusta, Georgia; Mountain Home, Tennessee; and 
Miami, Florida, we needed to notify patients that there was a 
small chance that because of procedures they had undergone they 
might be at risk of being infected with the viruses that cause 
Hepatitis B or Hepatitis C, or the human immunodeficiency virus 
or HIV.
    Each of the four medical centers took prompt action to 
notify veterans who might have been infected. They offered them 
testing, counseling, and treatment, if needed, and they made 
changes to their procedures to ensure that they were in 
compliance with the manufacturer's reprocessing instructions.
    As of June 8th, 2009, VA has identified 10,617 veterans who 
have been exposed to the risk of infection. Ten thousand six 
hundred and eight of these veterans have been notified of this 
risk, and 10,109, or 96 percent, have responded to our 
notification. VA is conducting an intensive outreach effort to 
find the remaining 419 veterans, and we will leave no stone 
unturned in doing so.
    To date, 13 veterans have tested positive for the Hepatitis 
B virus, who VA did not previously know had that virus. Thirty-
four have tested positive for Hepatitis C, and six veterans 
have tested positive for HIV.
    VA has taken a number of additional steps to ensure that 
throughout our system endoscopic equipment is properly set up, 
used, reprocessed, and maintained. We have provided all 
facilities with a patient safety alert discussing the proper 
way to accomplish these tasks, sent out two reminders on the 
subject, and asked all facilities during the week of March 8th 
through the 14th to take a time out to review their procedures 
in that area.
    More recently as a result of receiving a draft version of 
the Inspector General's report you just received, we required 
every facility to certify that all employees who work on 
endoscopes were not only trained, but that their supervisor had 
certified that they could properly reprocess all endoscopy 
equipment owned by the facility, and that standard operating 
procedures for reprocessing all equipment were on file and 
available.
    We will be conducting unannounced inspections in the weeks 
and months ahead to verify that these procedures are in place 
and that the competency of the staff to perform them continues 
to be documented.
    We were disappointed, as you no doubt are, by the IG's 
report, and we will redouble our efforts in that area.
    Thank you again for the opportunity to testify.
    At this time my colleagues and I are prepared to answer 
your questions.
    [The prepared statement of Dr. Duncan appears on p. 55.]
    Mr. Mitchell. Thank you. Dr. Duncan, a couple questions. 
How is it possible that these reprocessing issues surrounding 
endoscopy were so widespread throughout the VA?
    Dr. Duncan. Are you referring to the results of the IG 
report?
    Mr. Mitchell. Right.
    Dr. Duncan. How is it possible? I can't answer that 
directly other than to say that the IG required that we have 
model specific SOPs as they testified in the last panel.
    We were not up to that standard, but as Dr. Herbers pointed 
out, we did--in many cases there were SOPs in place.
    Likewise the competency. We don't disagree with the IG that 
we should have the competency documented on every employee, and 
that is our goal. We need to do better on this and we will.
    Mr. Mitchell. All right. How can you assure our veterans 
that are having any type of endoscopic procedures today, 
tomorrow, in the future that they are safe in the hands of the 
VA? That is the key question now.
    Dr. Duncan. It is a key question, sir, and I think first of 
all we have been transparent and honest with our veterans, and 
that should reassure them that if we find a problem that 
impacts on their health they will know. That is a trust 
building measure and is something that we and our Secretary are 
committed to; that is the transparency.
    The problem of reprocessing endoscopes is a safety issue. 
And our goal in all safety issues is zero defects. That is the 
goal of all high reliability organizations. Be it airlines, 
nuclear energy, and manufacturing is to have a high reliability 
organization. And the goal is zero defects. I am unaware of any 
organization that has reached that, but that is our goal, and 
our veterans can rest assured that we are aggressively seeking 
out problems and when we find them address them.
    Mr. Mitchell. You mentioned maybe not having zero errors. 
Let me ask everyone on the panel if they have ever worked for a 
private health care facility before, and how would a private 
health care facility handle this issue?
    And along with that, since all of these have gone public, 
what kind of questions or is anybody in your area, your 
geographic area, have they phoned you to ask about your 
procedures and your findings, and do other people even in the 
private care have the similar problems?
    Dr. Duncan. Okay, there are two parts to your question. I 
think we have a number of people who have worked in the private 
industry that can give you some perspective--their perspective, 
and then Dr. Vera would like to comment specifically on some of 
the inquiries that his facility has received.
    Mr. Biro. I have worked in the private sector for over 20 
years, leaving practice in the mid-1980s, and I was on a risk 
management committee of a 1,000-bed medical center. The way it 
would have been handled at least in the mid-1980s would be to 
look at the relative risk or chance of infection and then make 
a decision at that point. I can tell you at least then there 
would not be any massive notification unless the risk was 
extremely, extremely high. If it was one or two or three or 
four we would wait to see what would happen and use the tort 
system to see how it played out.
    Dr. Duncan. Thank you, Mr. Chairman. John.
    Dr. Pellecchia. Yes, before coming to the VA in 1986 I had 
been on the staff of a 750-bed hospital, and prior to that I 
had been in academic medicine--working for LSU medical school--
and I can say that with the private sector this type of thing 
would have gone to a risk manager and the lawyers, and unless 
it was discovered by the tort claim system you may not see any 
advertising at all, and when it got to the tort claim system, 
that is when it would get into the newspapers.
    Mr. Buyer. Mr. Chairman, the two individuals that spoke 
need to identify themselves for the record.
    Dr. Pellecchia. I am sorry, I am Dr. Pellecchia.
    Mr. Biro. Larry Biro.
    Mr. Vara. Mr. Chairman, this is John Vara, I am the Chief 
of Staff at Miami.
    The first piece is commenting in terms of past practice at 
private facilities. I think that the issue about candor and 
health care is one which this Committee cannot ignore.
    It is extraordinarily difficult as a physician or a 
provider to take a look when mistakes are made and how you deal 
with patients.
    In this particular circumstance in Miami, there were no 
patients identified who were harmed. In the private sector, 
that would not come forward in any way, and that it would be 
only when a patient is harmed that some action would be taken. 
So you know, I think that that is a big piece.
    The second piece that I would add is that after the news in 
Miami hit the press on Monday the 23rd, by the evening of the 
24th, a little over 24 hours later, our Infection Control 
Department had received 4 phone calls from other community 
hospitals, because they had gone to take a look at their 
processes and they had found some difficulties and wanted some 
advice.
    So I think that the issue is as Congressman Buyer mentioned 
earlier, this is a bigger issue than just the VA, but we are 
determined to come out and be open about it so that we can 
continue to improve our processes and patient safety as we have 
done with methicillin-resistant Staphylococcus aureus and some 
other activities.
    Mr. Mitchell. Thank you. Dr. Roe.
    Mr. Roe. Thank you. One of the things that I was impressed 
with, and you are correct in your comment, and I have been in 
private practice my entire career, but you spoke volumes for 
tort reform. When you brought that up, it is good for the 
private sector to bring these things out in the open and 
discuss them, the cause of that.
    And I guess what I am asking, is when this directive first 
came out Dr. Duncan, and I am reading right here from the 
National Center for Patient Safety, the first patient safety 
advisory was in March of 2003, and reaffirming to the facility 
that the water channel system and so on, so that has been known 
for what is it, 6 years? And you still, as I said, if this 
would have been an airplane taking off it would have crashed. 
And we didn't follow that or have the procedures to protect our 
patients. And after all, that is what we are there to do.
    The Chairman asked a very, very important question. If I go 
to my VA hospital right now and I say--and I am the patient--am 
I going to be fine? I read this in the newspaper. What can you 
do to reassure that veteran, I am going to be okay? And I 
understand that the incidence is very, very low, but somebody 
wins a lottery too, and this can happen to somebody; a patient. 
If it happens to you, it is 100 percent.
    Dr. Duncan. Well, Dr. Bagian, do you want to address the 
March 2003? With your analogy, we are very fortunate, Dr. 
Bagian is an astronaut so he can address your concerns there.
    Dr. Bagian. This is Jim Bagian.
    Well in 2003, as you know, there was an alert that we put 
out about making sure the channels were completely clean. Since 
then, we have had several other alerts referring to endoscopes, 
the most recent one being in December. There have been other 
ones having to do with reprocessing the equipment as well. In 
fact we testified about similar alerts before the Committee 
about 3 years ago. We looked at the BK Transducer at that time, 
and that was a case where actually manufacturer's instructions 
were incorrect, and we turned that up early and it resulted in 
it being a change for everybody, and we worked extensively with 
the companies and the FDA, as we have this time as well.
    The one thing that we pointed out and the VA took action, 
not just to tell people to go check that you do things, that is 
necessary to do, people actually do these, these aren't done by 
robots. So there is both people in the SPD that process this 
equipment as well as the clinicians.
    There is, you know, if you read the IG report, if you look 
at Appendix B, and I would, you know, that is only like three 
pages, it is worth the read. I wrote it, that is why I think it 
is worth reading. But Appendix B goes into many of these 
things, and we came out in 2006 working with infection control 
and others and we came up with a self-assessment so people 
would have a quality--I wouldn't say it is an in-depth--but a 
quality assurance document to see what went on.
    As we got into this right after it came out in early 
January of this year, Mr. Feeley, who is the Deputy Under 
Secretary for Health Operations and Management--I always forget 
what the abbreviation is--but anyway, Bill Feeley asked us to 
go and actually make a site--this goes back I think to Mr. 
Buyer's question--about who else checks, you just have them 
check themselves. And Mr. Feeley had us go out there and we 
went to Iowa City.
    At that time, we came back and we submitted a report and 
the IG has this report, and we went through a number of the 
systems issues. That you know, it is one thing certainly that 
people should be asked to be competent and do all the things 
that have been discussed, you know, that you have heard already 
about ad nauseam, but also if you don't have other systems 
going through the industrial process--you know, because this 
can be a six sigma process. This isn't like trying to figure 
out a diagnosis, this is about really an industrial process.
    These are devices that we know how they are made. It is not 
that they are made randomly. The manufacturer has specific 
instructions and there are ways to verify to make sure there is 
competency and have certain quality checks.
    In health care in general, and also at the VA, there are 
traditional not what I would call robust quality control and 
quality assurance processes that are used for scopes. If you 
contrast this, for example, with the clinical labs, like when 
you have blood drawn, they have a number of--and as you know 
Mr. Roe, there are a number of checks that go on every day that 
are specified. That is almost--I won't say completely--but 
almost unheard of anywhere else in health care, though it 
should not be.
    And I think we should look at this and we are starting to 
do that. To look at as we do say in aviation. You know, the 
aviation mechanic is not the highest paid person at the 
company, but they understand if he doesn't do his job well, the 
company will cease to exist. I think the same thing applies to 
SPD.
    We made recommendations back on the 28th of January to Mr. 
Feeley, he immediately put out that people should check again. 
We then made the recommendations, it is in Appendix B, on the 
17th, and just what 2 weeks ago, I guess 2 weeks ago--there was 
a meeting at VACO--at VA Central Office--to say how can we do 
this besides just telling people to be careful, which is 
ineffective and we have seen that. And that is the traditional 
way medicine has done it.
    So I think we were guilty of maybe thinking that we could 
do it the traditional way, and we have to understand, we have 
to go to the next level and do this in an industrial way.
    Mr. Roe. I disagree that it is just done the traditional 
way. Because I have worked in hospitals and we have very rigid 
protocols that we go through where we are. And I think that 
these are good people and these are smart people trying to do a 
good job, and I think the leadership is where you insist that 
this be done and it will be done. They will do that. I mean, I 
know, I have worked with those folks.
    Dr. Bagian. Well, if I may disagree a little bit, maybe the 
semantics thing. There are protocols but we know people don't 
follow them.
    For example, in this particular case one of the reasons 
that Miami had to notify patients was because the endoscopist, 
you know, or the team that would do the endoscopy--was it you 
that talked about the time out or the pause? You know, when 
they did the endoscopy you are supposed to flush--you know, the 
flushing solution, the saline through the end of the scope. 
They only did it 50 percent of the time. That is a critical 
step. But when we talked to many physicians they said, well you 
can do what you want and I don't need it to see, and they fail 
to understand that it is not just so that they can flush the 
end of the optic to see, that it also has an effective control 
function which they failed to appreciate. So that is not unique 
to the VA.
    Mr. Roe. Not to interrupt, but my time is up. But you bring 
up another point which was brought out, that you do need rigid, 
rigid continuing education, and that maybe hadn't been done 
anywhere along the time. But I can tell that you have a system 
set up regularly, that you have the 6 months or whatever it is 
or once a year that you go through these things again and 
again. And we have done that at our hospital where even if it 
is routine.
    Dr. Duncan. We agree.
    Dr. Bagian. You are absolutely right, we agree, that is one 
component. But you have to realize, for instance, if there were 
quality control and assurance measures in place, for example, 
the MAJA55, the water tube which is what we are talking about, 
the auxiliary water tube which was not cleaned between every 
patient on some of these ones is one of the issues, the scope 
was cleaned. Okay? They should both be cleaned, you know, after 
each patient. If they had just been looking at a bookkeeping 
thing to say how many scopes did he clean? How many MAJA55's 
did we clean? The numbers should be the same. They weren't. 
There was no process in place.
    So you know, there are a number of things like belt 
suspenders. You never want to be reliant just on people 
following procedures. If that is what you do eventually 
somebody is not perfect, they have a bad day, they are 
distracted, they are tired, whatever.
    Mr. Roe. Okay. Thank you, Mr. Chairman.
    Mr. Mitchell. Mr. Buyer.
    Mr. Buyer. I yield to the Sergeant Major.
    Mr. Walz. Thank you, Mr. Buyer, I appreciate that.
    First of all, I would like to thank each of you for serving 
in the VA. I have no doubt that each of you with your expertise 
could choose to go elsewhere and you have not, so you have 
chosen to serve our veterans, serve our country. I very much 
appreciate that.
    I also very much understand that you are under a spotlight 
on reporting negative events and medical errors unlike the 
private sector, and I agree with Dr. Roe in bringing that out. 
Now he and I could debate long and hard on the role of tort 
reform in that, but we will save that for another day. But the 
fact of the matter is, that is very important, and it is not 
lost on us, so we understand where you are at.
    Just a couple of things that I wanted to try and get at, 
and I think Dr. Roe's expertise did bring up something here and 
your comments back to this. Listening to Dr. Bagian, especially 
coming as an astronaut in an Air Force culture type of thing, 
are there checklists on this? Is anybody checklisting these? I 
mean, is it recorded after these things are done? Can anybody 
comment on that? If I were to go and look just as a layman 
could I see a checklist that each of these parts was cleaned in 
a certain way?
    Dr. Pellecchia. If I can address that at least for Network 
Nine, which I represent. Is that when all of this came out in 
February, we established a team of individuals from the network 
and also chiefs of staff from the different medical centers to 
put a new set of eyes on each of the medical centers on each 
one of those areas where we actually looked to see could we 
find that the specific training, one, had been accomplished, 
two, that it was obvious to us that it is available to us on 
the site where it was done, and whether the competencies for 
that individual could be demonstrated.
    We did our first cut during the last week of February and 
during the critical week in March. We did consultation reviews 
for those areas where we felt there needed to be improvement. 
We have used a standardized tool and a retrained program for at 
least annually for all those who are currently competent has 
been set in place. And we had made a second review spot check. 
Again, new sets of eyes, different medical centers, using the 
same tool, and we will continue to do that until we have----
    Mr. Walz. And this tool looks like a checklist? I may be 
oversimplifying here and not coming from a medical background, 
but when I go into a gas station restroom it says this was 
cleaned by Mary at 9:10. Is there something like that? Yes, 
ma'am?
    Ms. Berrocal. I actually had the opportunity, recently--I 
am Mary Berrocal, Miami--I recently had the opportunity to go 
to one of the Air Force bases and observe the pilots as they 
prepared to take off and I also observed how they were 
maintaining the engines of the fuel tankers. And actually one 
of the things that I noted was precisely that the pilot, one of 
them had flown 150 missions over Iraq, so recently, as he was 
engaging and starting the plane he went through his little 
checklist.
    Mr. Walz. Even though he or she could do it in their sleep.
    Ms. Berrocal. Right.
    Mr. Walz. They still do it. That is my point.
    Ms. Berrocal. Right.
    Mr. Walz. This is routine. Dr. Roe's point is it is the 
routine that gets you if you don't checklist it.
    Ms. Berrocal. So we are implementing that.
    Mr. Walz. Very good.
    Ms. Berrocal. In addition to that, you know, I notice that 
they work in a buddy system which we implemented. We also 
developed a knee board where the SOPs are also readily 
available and they can be in the procedure room so that they 
can refer to them if necessary.
    Mr. Walz. Very good.
    Ms. Berrocal. The other thing is that I have initiated 
discussions with the Air Force base to partner with them to 
provide training so that we can kind of like take our 
technicians to that area so that they can observe and 
understand the relationship between the need to do it and----
    Mr. Walz. I think that is the stuff we are looking for. The 
next thing I would bring up would come back to this, and this 
is my last or broader question.
    I understand the reason for giving the VISNs a lot of 
control so that the decision is made on the ground. Are we 
going to have VISNs doing this differently, some with 
checklists, some without or whatever, or is there going to be a 
uniform approach? Dr. Duncan.
    Dr. Duncan. Thank you. We have adopted a progressively more 
intrusive series of requirements on our medical centers. And as 
we found that we have not reached our goal of doing it right 
every time for every veteran, we are preparing and have 
prepared a directive about reprocessing not just of 
colonoscopes, not just endoscopes, but all reusable medical 
equipment.
    We are looking right now into standardizing at the level of 
facility so that we have the minimum number of scope, 
standardizing our SOPs across our system and that they are 
electronically available, and standardizing our document 
management so that when changes to those SOPs occur that 
electronically those changes are made, that the document 
management--that those changes go out and it is verified to 
every staff member that needs to see them. When SOPs become 
obsolete they are automatically retired, so that there is no 
confusion.
    So we agree with the IG that this needs to be viewed not as 
a medical process, but as an industrial process, and put into 
place the oversight, the controls, the quality controls that we 
need to get those defects as close to zero as possible.
    Mr. Walz. I appreciate that and I very much agree with that 
much, and I appreciate hearing that.
    The Ranking Member, I thank you for yielding your time, and 
I yield back.
    Mr. Buyer. Now will you yield to me?
    Mr. Walz. Absolutely.
    Mr. Mitchell. Can I have one followup real quick?
    Mr. Buyer. Sure.
    Mr. Mitchell. Ms. Berrocal, you mentioned what you are 
doing now in Miami. Is that a process that can be done in all 
of the hospitals, and is there a--look not every hospital had--
some of them passed the test, some of them were doing the 
procedures correct--is there a best practices that you review 
and say these people had no problems, why can't we do it that 
way? And if what is happening in Miami with the new process 
maybe that ought to be adapted everywhere.
    Dr. Duncan. Excellent point, sir. We do have mechanisms in 
place where we allow our medical centers to share lessons 
learned about notification and disclosure, as well as best 
practices in SPD.
    Key to what we feel we need to do to take this to really an 
unprecedented level in SPD is to standardize across our system 
so that we don't have procedures being done 153 different ways 
in 153 different facilities, or worse yet being done 
differently in the same facility in different clinics.
    Mr. Mitchell. Thank you. Mr. Buyer.
    Mr. Buyer. Thanks. I want to build off of the Sergeant 
Major's line of questioning.
    I know Dr. Duncan what your testimony just was. What I 
embrace the most was the latter two sentences of your 
testimony, because I think that was responsive to the Sergeant 
Major's inquiry.
    The Sergeant Major looked at it because he has been 
responsible for trucks, you know, tanks, jeeps, artillery 
pieces, he knows what things need to be done and he looks for 
the checklist when he goes and does his unannounced visits that 
First Sergeants, Sergeant Majors like to do, show me your 
paperwork. Right? So that is how he is looking at it.
    And so Dr. Bagian, when you mentioned six sigma, I also got 
excited. So when you mentioned this as an industrial approach--
you haven't done that yet--so that is why I discount the first 
part of your testimony. You can't say okay this is how we are 
going to move out squarely and then at the last part you 
mentioned we should have an industrial-type approach.
    So the reprocessing of the endoscope equipment, if it is an 
industrial process for which we now agree, then we should be 
applying a six sigma process to this and it would be 
beneficial. You mention this in your appendix.
    Dr. Bagian. Right. I thought it was six sigma reliability, 
not necessarily the investigation technique; just to 
differentiate, but the reliability should be at that level, no 
question.
    There has been discussions about this for quite some time 
as I pointed out, you know, we have done it for--we have talked 
about it for 3 years, but there was always discussions about 
should we go to that direction or not, and the decision was 
never made to go that way. I think now is the----
    Mr. Buyer. Is the decision now to go that way? The last I 
heard from Dr. Duncan? Is the decision now to go this way?
    Dr. Duncan. Yes. The VHA has decided that what we have been 
doing, business as usual, is not satisfactory, and that the way 
forward for us is to try to impose some of these industrial 
manufacturing standards to these processes. How to do that 
since there are not a lot of models in health care, the only 
area of health care where this has really been applied has been 
in the laboratory.
    Mr. Buyer. All right, well hold on.
    Dr. Duncan. Okay.
    Mr. Buyer. Hold on. Dr. Bagian, you just said you wrote 
Appendix B. The first patient safety advisory on reprocessing 
medical devices was issued on March 6th of 2003. What caused 
that first patient advisory back in March of 2003?
    Dr. Bagian. That is a good question. Virtually all of 
these. In fact every one of these, unlike you see from other 
sources were due to either self-reports or industry making us 
aware that they become aware. Not just the VA, but globally 
there had been an issue. And they come from both things.
    As contrasted to the studies that were mentioned in the 
previous panel where they talked about Hepatitis B, Hepatitis C 
transmission, those all were--there was an epidemic. That is 
under the classic definition, you know, an outbreak of where 
all these people have a disease now why did it happen? All ours 
really do is the proactive work on the part of either, you 
know, talking to the manufacturers or the manufacturers talking 
to us----
    Mr. Buyer. March 6th, 2003.
    Dr. Bagian. Oh, no, no.
    Mr. Buyer. Get me to that one.
    Dr. Bagian. In the 2003 that was the Olympus. Let me look 
at the summary and I will just tell you. I don't memorize each 
one and I would be foolish to say that I did. But that was the 
Olympus Exera gastrointestinal endoscopes, and there was an 
alert there about verifying that. The ones past that are 
actually more germane to your point, which is the ones where we 
went out with a self-assessment, we got the 2006 after BK. At 
that time there were discussions about and we had talked about 
it, in fact Dr. Rosell, SPD, Infectious Disease reported in 
March of 2007 to the Under Secretary's Coordinating Council for 
Quality and Safety that when they did the self-assessment, 
which we participated and helped construct, that there were 
still problems here. At that time we had advocated 
restructuring of the reporting mechanisms that occurred of how 
we verified these things, but at that time it was not adopted. 
And I can just tell you that was a decision made because I 
think they were looking at the traditional way it worked.
    Mr. Buyer. All right, well I am going to call ``time out'' 
on you. Hold on, hold on, hold on. Hold on, time out. I am 
going to send you to the U.S. Senate. I feel like I am talking 
to a Senator.
    I asked a very specific question. What caused you to do 
this on March 6th of 2003? I will tell you what, why don't you 
answer that question for the record for me, okay? May I have an 
additional few minutes? I think that would be helpful for us. I 
want to know what caused you to do this first assessment. 
Because I use that--you mention this in Appendix B, so I use 
this as your starting point, so here we are in 2009, we are 
going back to 2003 as your first patient safety.
    Dr. Bagian. It wasn't an alert, it was an advisory. We have 
two types. And that was due to Olympus coming out with what is 
called, an ``Important Safety Notice'' on February 10th, 
2003.''
    Mr. Buyer. Okay.
    Dr. Bagian. And they said would you please tell all your 
users. So that was a pass through. So that is different than 
the other ones.
    Mr. Buyer. Okay. All right, thank you.
    Dr. Duncan, in your testimony you state that VHA conducted 
a self-evaluation assessment on reprocessing endoscope 
equipment in fiscal year 2007 and again in 2008 and again this 
year, but in light of the IG's findings do you still endorse 
self-reporting--or excuse me--self-evaluation assessments?
    Dr. Duncan. The answer is yes, but that is not the whole 
answer. I think we have to, as a learning organization, allow 
our facilities and our staff to find problems, and I think we 
should allow them to have a chance to fix those problems. 
Clearly that is not the whole answer and we are not advocating 
that.
    We have instituted a much more direct and intrusive 
unannounced evaluation of our facilities in this area. We have 
our SPD program goes out and does evaluations of the SPD 
sections. And we also are currently undergoing a random 
unannounced inspection of all our facilities to make sure that 
we are in compliance and that model specific SOPs and 
documented competencies for every staff are in place.
    Mr. Buyer. Self-assessments are important. We do that in 
our own personal lives every day, right?
    Dr. Duncan. Yes.
    Mr. Buyer. So I don't want to ever do away with self-
assessments.
    But would you please provide to the Chairman and this 
Subcommittee the results of the 2007 and 2008 self-assessment 
survey, a list of the names of all VHA senior managers who were 
briefed on the results, and I would like to know what remedial 
actions were recommended and when were they actually 
implemented? Okay? Thank you.
    [The VA subsequently provided the results of the 2007 and 
2008 self-assessment survey in response to Question #6 of the 
Post-Hearing Questions and Responses for the Record, which 
appear on p. 69, but did not provide a list of the individual 
names of the VHA senior managers who were briefed on the 
results. National summary results of the observational 
assessments were presented to groups, by staff from the 
National Infections Diseases Program, which were listed.]
    Dr. Duncan. Be glad to do that, sir.
    Mr. Mitchell. Thank you. Mr. Meek.
    Mr. Meek. Thank you very much, Mr. Chairman.
    Dr. Duncan, I wanted to just I guess reel the tape back. I 
remember we were down the hall in the big Committee room a 
couple of months ago; is that a fair assessment?
    Dr. Duncan. Yeah.
    Mr. Meek. Okay. And three Members of Congress outnumbered 
by people that are working within the VA, especially on the 
medical side assuring us that everything is being taken care of 
and that we will not find ourselves in this situation that we 
are in today, and now we have a report that was released this 
morning that said they took 2 days, May 13th and 14th, and to 
take a look at what is going on out there in the field, and we 
find that training of the staff was 50 percent at the time and 
that the recommendations to follow simple operating procedures 
were not followed. And today, you come here today and you say 
we have a new attitude, we are going to go a little further 
now.
    I am not a veteran, but I represent veterans. I am pretty 
sure there are more veterans in this room than any other 
Committee room on Capitol Hill right now. We have veterans on 
the Committee and that is leading the Committee. We have 
veterans that are sitting behind you that are representing 
groups that represent veterans. I am pretty sure a super 
majority of you all at the table are veterans. And so I don't 
think that anyone set out to say let us see who we can infect 
today, but I can tell you that I do not believe as someone who 
has gone to the Miami Medical Center and have worked with not 
only the director, but the medical director and walked through 
the doors of what a veteran goes through when they go to get 
tests to see if their health care has been compromised, I still 
sit here today after 2 plus hours in this hearing and still 
feel a lack of confidence of what veterans are going through 
right now, that are going through the procedure that is in 
question.
    When can we say that a veteran should have all confidence 
that procedure is being followed?
    I know that there has been testimony from the table there 
that we are being held at a higher standard. Well, we are 
dealing with individuals that have been held at a higher 
standard their entire career, so they know what that means, 
especially for our enlisted men and woman, and also for our 
officers that are serving on this Committee.
    I am just trying to get to the point of feeling a little 
better when I brush my teeth in the morning that things are 
going like they are supposed to on behalf of veterans. I want 
to know when will that moment take place? When can I tell my 
constituents and my veterans that are concerned right now, 
because they pick up the newspaper, they watch the news, they 
say I cannot believe this is still happening, talk to me.
    Dr. Duncan. Well first of all let me say that the IG 
report, we were extremely disappointed at the findings of the 
IG report and we regret that we were not 100 percent in 
compliance.
    Just to take a fine point on your comment. The IG was 
looking for the presence of model specific SOPs. It wasn't the 
presence of SOPs, it was model specific SOPs. It didn't mean 
that they didn't have SOPs. We agree with the IG, they need to 
be model specific. And they did not evaluate the competency of 
the staff. They were looking for a written document that showed 
that that was there in their file. We agree that we should be 
able to produce that and we will work on that.
    I think immediately the veterans can be assured and they 
can have confidence in us that we are transparent, that we are 
up front, and we are honest with the medical care that we 
provide them, and if we do something that has a negative impact 
on any veteran's health we will tell them. That is our pledge 
to our veterans.
    I can tell you right now that we take this extremely 
seriously. And we have put in place guidance from Central 
Office to address these issues, and we are putting in place 
systems of oversight and quality control and standardization 
that are unprecedented so that we will provide the safest care 
for our veterans. That is what they deserve, and that is what 
we intend to provide them.
    Mr. Meek. Mr. Chairman, if I can just have 2 more minutes.
    I hear exactly what you are saying, okay? And I could see 
if I was a Member of Congress that wanted to just talk about 
the negative in this whole thing, but I think I have been 
pretty good with the VA. I mean, I have talked with the 
Secretary, I have talked to the directors in south Florida, I 
have even participated in information sessions and sat through 
all of it--not my staff, me--and I am not giving you secondhand 
information. This is what I have been told by you and others 
that this would be corrected.
    Now let me just say this very quickly, and I just want to 
make sure that we are crystal clear. This is not personal, this 
is business for me of following procedure. But guess what, on 
the flip side it is very personal for those that have gone 
through this, and it is very emotional for them, and I have 
bugs in my teeth of hearing the stories of real stories, not 
what I read in the paper, not what I saw in the news, not what 
I think is going on out there, but what has actually happened. 
And there have been some very courageous veterans sharing their 
personal medical experience with me. They didn't have to, but 
they did. So I can only imagine if some of them can sit up here 
and have a chance to have an open microphone with the VA and 
even with the Inspector General.
    And all I am saying is that I have heard what you are 
saying before, and I still go back to my question, not 
transparency, not that we care. Can a veteran go into the 
veteran facility right now, VA facility, to receive preventive 
examination as it relates to a cancer, that by age and by 
doctor recommendation that they should take, that their health 
care status will not be compromised?
    And if you are going to answer that question yes, then I 
want to know the things that you identified as what we are 
going to start doing, is that in place now? Was there a phone 
call this morning? Was there a video conference this morning to 
say yes, we said we were serious, but we are really serious 
now, and so you go through the numbers. Is there a manager 
standing over someone that is getting ready to carry out a 
procedure saying okay, have you properly cleaned this 
equipment? Have you properly followed the procedure? That is 
what I am talking about. Because I have too many veterans that 
are now saying Kendrick, can I go somewhere else, because I 
can't walk into the facility, and we have just dropped 
unprecedented dollars in investment into the VA. So if there is 
an argument that the resources are not there or that you don't 
have the means to do it then we need to hear it.
    Ms. Berrocal. Sure. Thank you Congressman Meek, and thank 
you so much for taking an active part at coming to the Medical 
Center and actually viewing the efforts of the Miami VA. I 
appreciate that.
    I do want to give you some assurances about the Miami VA. 
We have made extensive reviews. We have been reviewed by 
external bodies. We have provided training to our staff locally 
from our Medical Center. We have received training from experts 
in Central Office. We have received training from individuals 
at other VA medical centers that are considered to be experts 
at that. We have sent our staff to the Richmond VA to receive 
training and observe how other places have done it. We have 
validated competencies of the individuals. We have re-worked 
the SOP's----
    Mr. Meek. Sorry, Mr. Chairman, if I can, I am sorry, and I 
am sorry to cut you off.
    Dr. Duncan, I asked you a question, I don't have an answer. 
I know the Miami VA, they are under a real microscope. Everyone 
is paying attention. This thing is bigger than Miami.
    I want to know if a veteran walks into a VA facility, 
whether it be in Florida, Nevada, Washington State, wherever, 
can they be assured that their health care will not be 
compromised? Now you have told us time and time again, and I am 
sorry to get a little short fused with you, I need to know.
    Dr. Duncan. I will say that a veteran can walk into any VA 
hospital and my honest belief is that their risk of being 
harmed by the medical care that they receive is less than what 
it would be in the outside medical facilities.
    American health care has been recognized as being dangerous 
and does cause deaths. It is the sixth leading cause of deaths 
in the United States, and that is in the Institute of Medicine 
report that came out a number of years ago about patient safety 
in American health care.
    I cannot guarantee to any veteran that they will not have 
an adverse event occur in our facility. I can guarantee that we 
are dedicated and committed to reducing those adverse events to 
the lowest possible level, and we take that extremely 
seriously. We understand the impact that these events have on 
our veterans' lives. And we will do everything we do. But I 
can't give you a blanket assurance. And if I gave you that 
impression in previous briefings I apologize, because I don't 
believe anybody in any hospital can make that assurance.
    Mr. Mitchell. Thank you.
    Mr. Meek. Thank you, Mr. Chairman, thank you so very much.
    Mr. Mitchell. You are welcome. We need to get moving, 
because we have one more and we are running out of time.
    Mr. Meek. I know that, Mr. Chairman, I just want to make 
sure that we are clear for the record.
    Yes, we would like 100 percent, no one is 100 percent. I am 
not 100 percent, but I do know that we are still finding 
official reports saying that we are not even close to 100 
percent or 80 percent. So I just want to make sure that we are 
there and that the right attitude is in place.
    Mr. Chairman, thank you for the latitude.
    Mr. Mitchell. Thank you. Mr. Broun.
    Mr. Broun. Mr. Chairman, thank you so much for allowing me 
to be here.
    And to begin with I want to congratulate Ms. Wiley for the 
fantastic job she has done at the Augusta Charlie Norwood VA 
Hospital. I am very aware of the tremendous job she has done 
there, and I want to congratulate you publicly for the great 
job that you have done there. I am sorry these issues have come 
forth so that you have to be here today, but you have done a 
great job.
    Dr. Duncan, there seems to be some confusion among my 
constituents in Georgia about the timeline of events at the 
Augusta VA--Charlie Norwood Medical Center--and I was wondering 
if you could clear up the timeline for us. When did the 
facility become aware of the endoscopy sterilization problems? 
Was it in April, was it in November of 2008 or some other time?
    Dr. Duncan. I will ask Ms. Wiley to address that since she 
has personal knowledge about that.
    Ms. Wiley. Thank you. Thank you, and again we regret that 
this has occurred first of all.
    The endoscope that we are talking about is an ENT scope, a 
Rhino Laryngo Scope, which is a much smaller scope. It is 
approximately 8 inches long and it has no inner channel, so it 
has no cleaning requirements that require flushing.
    Mr. Broun. Let me interpret you here a minute. I just want 
to be clear for the Committee's perspective. Because as a 
physician who has done colonoscopies myself in my own medical 
practice and have been associated with ENT endoscopy, we are 
talking about a completely different situation here with the 
scopes at the Charlie Norwood VA; is that correct?
    Ms. Wiley. That is correct.
    Mr. Broun. Okay. I thank you for----
    Ms. Wiley. Thank you. In November we had a patient who 
asked the clinician while he was waiting for the procedure to 
be performed why we were using a super sani-wipe which is an 
aluminum chloride based product which is--kills everything--why 
we were using that when it would be perhaps dangerous for the 
mucous, it might irritate that.
    Mr. Broun. Let me interpret you again. I apologize, but you 
just made a statement, it kills everything. Does it kill 
Hepatitis B, Hepatitis C, and HIV?
    Ms. Wiley. It is my understanding that it does, yes, sir.
    Mr. Broun. Okay.
    Ms. Wiley. But it is not according to manufacturer's 
recommended cleaning requirements.
    Mr. Broun. I understand that. But it is a super cleaner 
that will kill these viruses.
    Ms. Wiley. Correct, on the surface.
    Mr. Broun. Even though this wasn't recommended it would 
kill the viruses when it was utilized in the manner that it was 
utilized; is that correct?
    Ms. Wiley. That is correct.
    Mr. Broun. Okay.
    Ms. Wiley. At the time that the patient made mention to the 
physician, we immediately stopped those procedures in that 
clinic. The physician immediately reported it to his 
supervisor, who was our chief of surgery, who at that point let 
leadership know, and we discontinued at that point all scope 
procedures in the ENT clinic.
    Subsequent to that and the following 5 days, we also did a 
step down throughout the medical center to ensure that we had 
no other lapses in any of our other scope processing activities 
at the medical center at that time.
    And subsequently in January, we had the VA senior officials 
conduct a CRAAB at which point it was determined that we need 
to notify our patients that there might be a potential risk; 
however, very, very minimal.
    What you are talking about in April is a series of e-mails 
that had to do with two employees that attended a conference, 
and there was some questions or controversy over where the 
supervisory responsibility needed to be for SPD in the future. 
If it needed to be under the infectious control guidance, under 
the chief of staff. That discussion and other query surrounding 
that was discussed in the Infectious Control Committee, but was 
not surfaced to my level until well after that time.
    Mr. Broun. Okay, thank you, Ms. Wiley.
    Dr. Duncan, I appreciate your written comments that the 
Department of Veterans Affairs number one priority is the well-
being of our Nation's veterans, and it very well should be. Our 
veterans have volunteered to serve our country, and it is 
unacceptable that their care--that any VA facility is 
inadequate. There is simply no excuse that some of these things 
went on so long, as far as I am concerned, and I know that you 
agree with me about that.
    Dr. Duncan. I do.
    Mr. Broun. At least I think you do.
    Dr. Duncan. I do.
    Mr. Broun. I appreciate the VA's accountability after the 
fact, but we expect much, and much more when it comes to the 
care and treatment of our veterans.
    My question for you today is this. Dr. Daigh said in his 
testimony that serious management issues need to be addressed 
by the VA with respect to the management of the industrial 
processes, such as reprocessing of the endoscopes.
    What is the VA doing to address its current management 
issues, and how can you reassure our veterans that the VA is 
doing everything in its power to resolve its endoscopy issues? 
This is what Mr. Meek was saying. And especially given that the 
Office of Inspector General Inspections in May showed that 
there is only a 43 percent compliance rate for proper staff 
training and appropriate SOPs are available.
    Mr. Biro. Well let me just say for VISN 7 and Augusta 
specifically. This is Larry Biro, the Network Director.
    What I did for the last go round of self-certification, I 
required my directors to personally communicate with me through 
e-mail using the ``I'' word. ``I went and looked, I did this, I 
did that.'' I will have to admit this is the first time I ever 
did this with all the self-certifications. At least I have a 
record, which was very revealing, because they could explain to 
me what they did, and they did find still some weaknesses at 
this last self-evaluation which had to be fixed, but at least 
now I have a personal bond with this disclosure.
    As other people know, and you do, I go to Augusta, and all 
my medical centers, VA every month, I will be there tomorrow in 
Augusta, and this will be a hot topic, and we have spent hours 
and hours on this. And my personal style is, I will be there 
looking and asking and tearing the place apart to see if it is 
being done appropriately in all my facilities.
    Mr. Broun. Well, I appreciate that.
    Actually my question was to Dr. Duncan, because my 
knowledge of what has gone on in the Augusta VA, it is a 
totally different situation there than we have at the Miami VA, 
for instance, but I am concerned about systemwide, and I 
appreciate your comments, because I congratulate what you all 
have done at Augusta, I think it is very appropriate what you 
all have putting into place, but I am really concerned 
particularly about the endoscopy and the things that have 
occurred with that. Because we are talking about two different 
situations here, and I just want assurances.
    Mr. Meek was saying that a veteran, if he goes to any VA 
facility, no matter where it is in this country, that those 
procedures--those process procedures, the industrial procedures 
are put in place so that veterans are absolutely very 
comfortable going to the VA to have a colonoscopy in Miami or 
any other place.
    Dr. Duncan. And I agree with you.
    To get to your question and your point exactly. We are 
committed to standardizing SPD functions, and we have done two 
things. One is we have already put out guidance to standardize 
the reprocessing of reusable medical equipment. We are also in 
the process of preparing a reorganization and a directive to 
reorganize SPD functions so that it looks the same in all 
facilities as far as who SPD is accountable to, what standard 
procedures are being used, that there is standardized document 
control, there is standardized training.
    And so we believe that and are committed to doing--instead 
of letting each facility sort of devise their own way of doing 
things, this is a departure. We have decided to try to 
centralize and standardize these functions so that when you go 
to different facilities they are doing things in the same 
manner.
    A directive, and I can't emphasize this enough, is a weak 
action unless we follow it up with careful inspection both at 
the local level and external, and that is being ramped up. And 
I have no doubt that we will be asked to come back and report 
to you what we have done and we look forward to doing that, 
because we feel this is a serious problem that needs to be 
addressed and we want to address that so we can assure our 
veterans that they are going to the safest facilities for their 
medical care that they so rightly deserve.
    Mr. Broun. Dr. Duncan, I appreciate that. There will always 
be problems that will always have to be fixed. Only one perfect 
person ever lived and that is the Lord Jesus Christ.
    But let me just refer you to this picture of the two 
different tubes used at Murfreesboro. If you look at the 
connectors they look very similar. And Congressman Buyer was 
talking about even fixing the things in the private sector.
    I request as you look at these things that something is 
done so that maybe the color coding is different for one-way 
versus a two-way connector, and that can very easily be done by 
the manufacturer, and I think there are a lot of things that 
can be done that are absolutely important to do so that will 
help veterans, as well as people in other facilities to 
understand that their procedure is perfectly safe--as safe as 
can be in human endeavor.
    Dr. Duncan. I have two comments and then Dr. Bagian I think 
wants to say something. First of all, Murfreesboro looked at 
this and as part of their root cause analysis, devised a 
mechanism for tagging those valves that should not be used so 
it would be clear. And I agree with you, we have brought this 
to the attention of the manufacturer, and if we could change 
the color of those valves we would. Jim.
    Dr. Bagian. Well certainly you want to design things so the 
easiest thing to do is the right thing to do. You want to make 
it more difficult.
    You know, we have had extensive discussions with Olympus in 
this case, and you know, we have had very productive 
discussions. In fact, I would say the testing that Olympus 
helped us really understand what patients were put at risk. 
Without that we would have been in far worse shape. And you 
know, my hat's off to Olympus and I think others would say the 
same for that.
    As to the color coding you have to look at other things 
that need to be done. Those two tubes as you showed in the 
picture, one is very short and it is used for cleaning only. 
Apparently what happened is--I forget who it was that said, you 
know, we still don't know--I think it was when the IG was 
talking--it is still unclear how they became pulled apart. They 
shouldn't be pulled apart and disconnected at all.
    So the step for instance that Murfreesboro was taking where 
they tagged the one I think is an adequate step. There are 
other reasons why you wouldn't want to use different colors, to 
be quite honest. So I think that is right. Olympus is not the 
only manufacturer as you heard before, so there are issues that 
have to do with that. We work with a number of manufacturers to 
try to look at, and we are looking at, both their procedures 
and have reviewed company's procedures to talk about how they 
could be less likely to be misinterpreted or ambiguous as well 
as designs, and we continue to do that.
    So that is certainly one of the components that need to be 
done, we would agree, but it wouldn't necessarily be color. I 
mean, there are a number of factors, that is but one I would 
say.
    Mr. Broun. Thank you very much, Mr. Chairman, I appreciate 
it.
    Mr. Mitchell. Thank you. Just one followup and then I want 
to ask Dr. Roe to follow up. The counsels for both the Majority 
and the Minority went to Bay Pines in Tampa and they use a 
disposable system and don't seem to have any problems. Is there 
a real cost difference?
    Dr. Bagian. Let me answer that one. That is an after market 
one, which also has certain advantages and disadvantages, we 
also work with that company as well. It is a very complex 
topic, and we can go into that, the issues about doing it. They 
both have their advantages and disadvantages, and we are 
working with all these companies to figure out if there are 
ways to make them more foolproof, if you will, less likely to 
error, and we are doing that.
    Mr. Mitchell. Well we have seen the issues with the 
reusable, and I don't want to go into another whole hearing 
about the disposable.
    I just want you to know also that with all the directives 
that you are going to give out, the publicity that this has 
gotten, the fact that I am sure systemwide everybody talks to 
each other, that the IG has been to a number of places, but the 
frustrating thing is that even though this all came out when 
they did their unannounced visits people weren't complying.
    I just want you to know that Dr. Roe and I have just 
talked, that we expect that when the IG goes back--and we are 
going to ask the IG to do this--within 90 days that he finds 
complete compliance with the procedure that you have in place 
that is going to eliminate this mistake period.
    Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman, thank you for chairing 
this meeting, I think it has been very helpful for everyone.
    And first of all, Dr. Duncan, you made a vigorous defense 
of the VA system. I would argue that the private health care 
system is not a dangerous place. I would say that hospitals are 
safe. Medical errors occur, but hospitals are by and large not 
dangerous places, they are places where we go hopefully to heal 
our patients.
    I do think that we need to be transparent as the VA has 
done, a confession is good, but it doesn't fix the problem. 
Saying I am sorry doesn't fix the problem. So we need to work 
on fixes to the problem.
    The other thing that we don't need to do for the people 
down the trenches--and I spent 31 years in the trenches--is 
have those omnipotent ones--us here from up above--shove down a 
bunch of paperwork on people and make their job a lot harder. 
This has got to be easy to do for them, where it is either a 
checklist or something that is fairly easy to do or they will 
push back.
    Now, I will also tell you that doctors are the worst about 
pushing back about changing. We hate change. But I recall when 
they brought the surgical pause in, where you stopped before 
you dropped the knife on somebody and you went through this 
procedure list. And I will tell you where that came from. Our 
volunteer State mutual malpractice company had the airline 
industry come in and talk to us on two different occasions 
about procedures. I think that has helped. As a matter of fact, 
I embraced it fairly early on because it made sense. If you are 
running from one operating room to another, this is Ms. So and 
So, you are going to do this, and have I got the equipment, is 
it prepared and so on. Those are good things to do. We need to 
change where it helps our patients. But in doing this, don't be 
so heavy handed that it makes it difficult for the people doing 
10 colonoscopies a day to do their job.
    And once again, I will say that I know their friends or 
patients or whatever that work at the VA hospital in Mountain 
Home. They want to do a good job. They are trying to do a good 
job. That is not the case. They are not out there deliberately 
trying to do anything wrong. I think we have got to help them 
and not make their job harder.
    And the Chairman and I have talked, and I think in 90 days 
that is fair. We should be able to look at that again in 90 
days and say we fixed this problem, and I think then you can 
look a veteran in the eye and say, you know, this has been 
looked at systemwide, and this problem has been resolved.
    Mr. Chairman, I yield back, and thank you for holding this 
meeting.
    Mr. Mitchell. Thank you very much. And I want to thank you 
for your service and all your help with veterans. And yes, Mr. 
Broun?
    Mr. Broun. Mr. Chairman, will you yield a second?
    I just want to thank you and the Ranking Member for having 
us who are not on this Committee participate as if we were 
Committee Members, because it is a concern of mine as a 
representative of the Charlie Norwood VA Hospital, just like it 
is for Mr. Meek and Ms. Ros-Lehtinen, and I really want to 
thank you and how much I deeply, personally appreciate the 
ability to be here and participate. Thank you so much, sir.
    Mr. Mitchell. Thank you. And before we gavel this meeting 
to an end, Ms. Brown, do you have a comment?
    Ms. Brown of Florida. Mr. Chairman, I just want to thank 
you for holding this hearing, and I am going to follow up with 
the IG, because I don't want this meeting to be about just 
talk, but what we are going to do to make sure that this 
doesn't ever happen again.
    Mr. Mitchell. Thank you. The hearing is adjourned.
    [Whereupon, at 1:11 p.m., the Subcommittee was adjourned.]

















                            A P P E N D I X

                              ----------                              

             Prepared Statement of Hon. Harry E. Mitchell,
         Chairman, Subcommittee on Oversight and Investigations
    I would like to thank everyone for attending today's Oversight and 
Investigations Subcommittee hearing entitled, Endoscopy Procedures at 
the U.S. Department of Veterans Affairs: What Happened, What Has 
Changed? Thank you especially to our witnesses for agreeing to testify.
    We are here today to evaluate endoscopy procedures used by the 
Department of Veterans Affairs. Since this Subcommittee was made aware 
of the improper reprocessing, incorrect usage, and substandard cleaning 
of endoscopic equipment--at Murfreesboro, Tennessee; Augusta, Georgia; 
and Miami, Florida--we have learned that approximately 53 veterans, and 
maybe more, were potentially exposed to HIV and Hepatitis. Exposing our 
veterans to that type of risk is unacceptable . . . and frankly, I'm 
outraged that any of our Nation's heroes were potentially infected or 
that they even have to worry about that possibility.
    We have been here before, and time and again, we have seen the VA 
violate the trust of those who have bravely served this country. The 
endoscopy issues in Murfreesboro, Augusta, and Miami are yet another 
reason for veterans to lose confidence in a system they rely on for the 
care we owe them.
    Most infuriating is the irony that these veterans were undergoing 
routine medical evaluations to keep them safe and to prevent illness, 
but ultimately, they may be in more danger now than before the 
procedure. Although we will hear today from the VA that it is difficult 
to determine whether illnesses diagnosed after these procedures 
resulted from the endoscopies or from unrelated exposures, there is no 
question that shoddy standards--systemic across the VA--put veterans at 
risk and dealt a blow to their trust in the VA. And I'll say it again, 
whether or not any veterans contracted illnesses from these procedures, 
it is outrageous that they even have to worry about that possibility.
    In response to these shocking wrongdoings, in December 2008 and 
January 2009, all VA Medical Centers were required to review their 
processes to ensure that they are in compliance with the endoscopy 
device manufacturer's instructions. This incident serves as yet another 
example of why standardization of VA medical procedures is needed. I 
expect that the VA can report today that all VA Medical Centers are now 
in compliance.
    I am also eager to hear what the VA has done to ensure that proper 
policies and training are in place so that mistakes like these will not 
happen again. I expect to learn what will be done to care for those who 
may have been exposed to HIV or Hepatitis. And I want to know how they 
are going to regain the trust of the veterans they serve.
    In closing, I would like to acknowledge the VA's cooperation as 
this Subcommittee prepared for today's hearing. But despite this 
cooperation and enhanced transparency with the new Administration, we 
must continue to provide persistent oversight to identify problems, 
motivate improvement, and help the VA to provide the safe, timely, and 
thorough care veterans deserve.

                                 
  Prepared Statement of Hon. David P. Roe, Ranking Republican Member,
              Subcommittee on Oversight and Investigations
    Thank you for yielding, Mr. Chairman.
    This very important hearing was scheduled at the request of Ranking 
Member Buyer due to the seriousness of the allegations involving the 
improper disinfecting and cleaning of instruments used during 
endoscopic procedures such as colonoscopies. I am pleased that we have 
the opportunity to review what procedures were in place at the time the 
incidents occurred in Augusta, Murfreesboro and Miami, and what the VA 
has done to address and correct the problems VA-wide.
    On December 1, 2008, the VA Medical Center in Murfreesboro, 
Tennessee identified a problem relating to the reprocessing of 
endoscopy equipment. VA Central Office requested that all facilities 
review their processes to ensure that they were in compliance with the 
manufacturer's instructions. These reviews identified significant 
reprocessing issues at the Augusta VA Medical Center and the Miami VA 
Medical Center. Both of these issues required patient notifications and 
testing.
    On February 9, 2009, the VA announced a ``Step-Up'' campaign 
scheduled from March 8 through March 14, during which all VHA 
facilities would review the safety procedures and processing protocols, 
with a special emphasis on retraining on the reprocessing of 
endoscopes, establishment of easily tracked accountability for 
instrument processing, and training on standard operating procedures by 
facility leadership. VA also began notifying veterans who were in the 
``risk pool'' of potentially affected patients. In total, VA has 
notified 10,320 veterans of potential risk. Nine thousand nine hundred 
fifty of these patients responded to the notification, 633 declined 
testing or an appointment for follow up; and 8,596 veterans were 
notified of the results of their testing. Out of all of these veterans 
who were tested, 13 were found positive for Hepatitis B virus; 34 were 
found positive for Hepatitis C virus; and 6 were found positive for 
HIV.a While the percentage of infections appears small, the 
issue at hand is the proper processing of equipment, and ensuring the 
ultimate safety of those veterans who have placed their trust in VA's 
hands for care.
---------------------------------------------------------------------------
    \a\ Numbers updated as of June 8, 2009, 4:00 p.m. from VA's Web 
site.
---------------------------------------------------------------------------
    On March 25, 2009, Ranking Member Buyer requested an IG 
investigation be conducted on the VA's Step-Up program, and to 
determine if there was a systematic problem throughout the VA in 
meeting the ``Step-Up'' training requirements.
    I am looking forward to hearing the testimony of the IG's office on 
its investigation into this issue. It is troubling that these steps had 
to be taken, but given the possible magnitude of the problem that 
occurred earlier this year, it is reassuring that VA has taken these 
steps to ensure patient safety at the VA medical facilities.
    The safety of our Nation's veterans should be our top priority when 
they come to the VA Medical Centers and Outpatient Clinics for care. 
When we fail to care for even one veteran properly, we have failed in 
our sacred trust. We can do better, and we will.
    Again, thank you, Mr. Chairman, and I yield back.

                                 
          Prepared Statement of John D. Daigh, Jr., M.D., CPA,
        Assistant Inspector General for Healthcare Inspections,
    Office of Inspector General, U.S. Department of Veterans Affairs
INTRODUCTION
    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to testify today on endoscopy reprocessing errors by VA 
that placed veterans at risk of viral infections as a result of 
endoscopy procedures performed at several VA medical centers (VAMC). 
The VA Secretary, the Chairmen and Ranking Members of our Oversight 
Committees, and other Members of Congress requested the Office of 
Inspector General (OIG) review VA's procedures at those facilities as 
well as nationwide. Our report, Healthcare Inspection, Use and 
Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical 
Facilities, was published today.\1\ I am accompanied by three members 
of my staff: George Wesley, M.D., Director, Medical Consultation and 
Review, Office of Healthcare Inspections; Jerome Herbers, M.D., 
Associate Director, Medical Consultation and Review, Office of 
Healthcare Inspections; Limin (Lin) Clegg, Ph.D., Director, 
Biostatistics Division, Office of Healthcare Inspections. As I have 
previously stated in testimony before this Subcommittee, I believe that 
VA provides high quality health care to veterans; however, I am 
concerned that the controls are not in place to ensure the delivery of 
a uniform, high quality medical benefit.
---------------------------------------------------------------------------
    \1\ http://www.va.gov/oig/publications/reports-list.asp.
---------------------------------------------------------------------------
BACKGROUND AND FINDINGS
    VA medical facilities have not complied with multiple directives to 
ensure endoscopes are properly reprocessed. Unannounced OIG inspections 
on May 13 and 14, 2009, found that medical facilities:

      Have the appropriate endoscope Standard Operating 
Procedures (SOPs) available 78 percent of the time.
      Have documented proper training of staff 50 percent of 
the time.
      Are compliant with both recommendations 43 percent of the 
time.

    The impact of improper high level disinfection of reusable 
endoscopes places veterans at risk of infection from viruses including 
Hepatitis B, Hepatitis C, and human immunodeficiency virus (HIV). 
Medical research has shown Hepatitis B and Hepatitis C infections have 
been transmitted through endoscopes. There has not been a documented 
case of HIV transmission with colonoscopes.
    As a result of the improper reprocessing of colonoscopes, 6,387 
veterans were notified by the Murfreesboro, Tennessee, VAMC, and 3,260 
veterans were notified by the Miami, Florida, VAMC, that they were at 
risk of these viral infections. Improper processing of ear, nose, and 
throat (ENT) endoscopes at the Augusta, Georgia, VAMC, resulted in the 
notification of 1,069 veterans that they were at risk for these same 
diseases.
    There have been multiple notifications to VA medical centers that 
reprocessing of endoscopes required close attention to detail and 
compliance with the manufacturers' recommendations for high level 
disinfection. The responsibility for reprocessing endoscopes is 
described in VA Handbook, ``Supply, Processing, and Distribution (SPD) 
Operational Requirements.'' \2\ Part 6 of the handbook addresses 
decontamination and states, in part, ``All reusable medical devices 
used in the medical center should be processed in the SPD 
decontamination area. If there are other areas of the medical center 
where decontamination must be done, all procedures listed in this 
section of the handbook will apply to that area.'' The handbook also 
states that staff reprocessing endoscopes ``should consult all 
manufacturers' instructions.''
---------------------------------------------------------------------------
    \2\ VA Handbook 7176, issued in 2002.
---------------------------------------------------------------------------
    On February 10, 2003, based on problems identified at non-VA 
facilities, the Olympus Corp. issued a safety alert entitled 
``Reprocessing of Auxiliary Water Channel on Olympus EXERATM 
Gastrointestinal Endoscopes.'' This notice reminded customers that 
``the auxiliary water channel must be reprocessed each time the 
endoscope is used.''
    On February 13, 2004, the VA National Center for Patient Safety 
(NCPS) issued an alert related to ``an incorrect connector being used 
to link cleaning solution to endoscopes during reprocessing.'' \3\ The 
alert required VA medical facilities to: (1) provide in-service 
training consistent with manufacturers' instructions for reprocessing 
specific models of gastrointestinal (GI) endoscopes, and (2) 
incorporate knowledge of proper handling and reprocessing of GI 
fiberoptic endoscopes into the Joint Commission competence assessment 
requirements for individuals tasked with this assignment.
---------------------------------------------------------------------------
    \3\ NCPS Alert, Proper Connectors for Sterilization of all 
Gastrointestinal Fiberoptic Endoscopes, February 13, 2004.
---------------------------------------------------------------------------
    Based on a January 2006 event involving the reprocessing of 
prostate biopsy devices, the Veterans Health Administration (VHA) 
conducted a national review in September 2006 to assess compliance with 
reprocessing standards. All VHA facilities conducted self-assessments 
and the aggregated results were published in 2007. Facilities were 
directed to create local policies based on manufacturers' instructions, 
including requirements for demonstration of competence in performing 
reprocessing.
    On December 22, 2008, in response to events at the Murfreesboro 
VAMC, NCPS issued a Patient Safety Alert regarding the incorrect tube/
valve combination and the frequency of reprocessing auxiliary water 
system accessories.\4\ The alert emphasized the importance of following 
manufacturers' instructions. The alert also required facilities to have 
SOPs available to all personnel who reprocess endoscopes and 
accessories and that staff be evaluated for reprocessing competence. 
Facilities were directed to certify compliance with these action steps 
by January 7, 2009. Sixteen facilities reported that they were not in 
compliance with the manufacturers' instructions for reprocessing 
endoscopes.
---------------------------------------------------------------------------
    \4\ VHA Patient Safety Alert AL09-07, Improper Set-up and 
Reprocessing of Flexible Endoscope Tubing and Accessories, December 22, 
2008.
---------------------------------------------------------------------------
    On February 4, 2009, the Principal Deputy Under Secretary for 
Health (PDUSH) and the Deputy Under Secretary for Health for Operations 
and Management (DUSHOM) sent a memorandum to all VA medical facilities 
announcing ``Endoscopy Step-Up Week'' for March 8-14 requiring that 
facilities ensure they have:

      Locally-developed device-specific SOPs meeting 
manufacturers' requirements for set-up and reprocessing of all 
endoscopes.
      Evaluations of model-specific competence for appropriate 
personnel who set up and/or reprocess endoscopic equipment.
      Assured accountability for reprocessing procedures in all 
areas and at all levels of the organization.

    The memorandum did not require reporting or certification of 
compliance. On February 9, 2009, VHA issued Directive 2009-004, Use and 
Reprocessing of Reusable Medical Equipment (RME) in Veterans Health 
Administration Facilities. This Directive formalizes the requirements 
specified in the February 4 memorandum.
    On May 12 and 13 of this year, the OIG conducted unannounced 
inspections of VA medical facilities to test the medical facility's 
compliance with VHA's leadership memorandum of February 4, 2009, 
establishing an ``Endoscopy Step Up Week'' March 8-14, 2009, and the 
February 9, 2009, VHA issued Directive 2009-004. For each colonoscope 
reprocessing location, we classified that reprocessing unit as ``SOP 
compliant'' if model-specific reprocessing SOPs were present for 
applicable colonoscopes; as ``competence compliant'' if at least one 
demonstrated model-specific competence record existed for each 
applicable endoscope; and as ``compliant'' if it was both ``SOP 
compliant'' and ``competence compliant.''
    From the sampling of colonoscope reprocessing units, the OIG 
projects that 78 percent of VHA colonoscope reprocessing units were in 
compliance with SOPs. We estimate that only about one out of two VHA 
colonoscope reprocessing units (50.2 percent) is in compliance with 
competency. The compliance with both SOPs and competency is estimated 
at 42.5 percent.
    The results of the unannounced inspections led to the conclusion 
that serious management issues need to be addressed by VA with respect 
to the management of industrial processes such as the reprocessing of 
endoscopes. The OIG report recommends that VA:

      Ensure compliance with relevant directives regarding 
endoscope reprocessing.
      Explore possibilities for improving the reliability of 
endoscope reprocessing with VA and non-VA experts.
      Review the VHA organizational structure and make the 
necessary changes to implement quality controls and ensure compliance 
with directives.

Clinical Risk Assessment Advisory Board (CRAAB)
    VHA Directive 2008-002, Disclosure of Adverse Events to Patients 
(January 18, 2008), provides guidance for disclosure of adverse events 
related to clinical care to patients or to their personal 
representatives. Adverse events are defined as ``untoward incidents, 
therapeutic misadventures, iatrogenic injuries, or other adverse 
occurrences directly associated with care or services provided within 
the jurisdiction of a medical center, outpatient clinic, or other VHA 
facility.''
    VHA Directive 2008-002 describes three adverse event scenarios and 
their corresponding notification processes:

      Clinical Disclosure of Adverse Events. This disclosure 
category pertains to disclosure of an adverse event to a single patient 
at the local level. Generally, such events referred to in this 
subdivision are of a relatively minor nature.
      Institutional Disclosure of Adverse Events. This type of 
disclosure focuses on ``cases resulting in serious injury or death, or 
those involving reasonably expected serious injury, or potential legal 
liability.''
      Large Scale Disclosure of Adverse Events. This type of 
disclosure is defined as ``involving a large number of patients, even 
if at a single facility.'' Authority and responsibility for large scale 
disclosures resides with VHA's PDUSH. Often the issues will be clear 
and the PDUSH will proceed according to the facts and available medical 
science. However, if the issues are unclear, the PDUSH can request that 
the DUSHOM convene the CRAAB, an ad hoc consultative board.

    CRAABs have permanent voting members that include representatives 
from the Office of the National Center for Ethics in Health Care, 
Office of Quality and Performance, National Center for Patient Safety, 
Office of Patient Care Services, and Office of Public Health and 
Environmental Hazards. Additionally, individuals knowledgeable about 
the case at hand, subject-matter experts, and stakeholders affected by 
the decision may be asked to participate.
    Key issues that the CRAAB is expected to address include the number 
of veterans exposed or potentially exposed; the probability that the 
adverse event will cause harm; the nature, magnitude, and duration of 
the potential harm; and the availability of treatment to prevent or 
ameliorate harm.
    VHA Directive 2008-002 recognizes that although it is difficult to 
weigh all benefits and harms, situations prompting a decision whether 
to conduct large scale disclosure of adverse events likely involve the 
following considerations.

      Are there medical, social, psychological, or economic 
benefits or burdens to the veterans, resulting from the disclosure 
itself?
      What is the burden of disclosure to the institution, 
focusing principally on the institution's capacity to provide health 
care to other veterans?
      What is the potential harm to the institution of both 
disclosure and nondisclosure in the level of trust that veterans and 
Congress would have in VHA?

    The CRAAB may choose to recommend notification if ``one patient or 
more in 10,000 patients subject to the event or exposure is expected to 
have a short-term or long-term health effect that would require 
treatment or cause serious illness if untreated.''
    With respect to the colonoscopy reprocessing issues at the 
Murfreesboro VAMC and the Miami VAMC, the CRAAB unanimously voted for 
patient notification. The CRAAB was charged with addressing the Augusta 
VAMC ENT reprocessing incident, but as the facts became clear, 
notification proceeded without requiring formal CRAAB meetings.
    As a result of the National Patient Safety Alert of the December 
22, 2008, 16 VA facilities (other than Murfreesboro) reported 
reprocessing problems with tubing that connects to the auxiliary water 
line of colonoscopes. The CRAAB, over a series of meetings, and after 
reviewing scientific literature and conducting further evaluations, 
voted unanimously to recommend that veterans not be notified of these 
reprocessing issues as the risk of cross contamination of patients was 
so small as to be clinically insignificant.
CONCLUSION
    The OIG's review of these issues concludes that the CRAAB has been 
an effective mechanism for providing guidance to VHA leadership on 
disclosure of adverse events to veterans. However, the results of our 
unannounced inspections led to the conclusion that serious management 
issues need to be addressed by VA with respect to the management of 
industrial processes such as the reprocessing of endoscopes.
    Mr. Chairman, this concludes my statement and we would be happy to 
answer any questions that you or other Members of the Subcommittee may 
have.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

      Prepared Statement of William E. Duncan, M.D., Ph.D., MACP,
    Associate Deputy Under Secretary for Health, Quality and Safety,
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Good morning, Mr. Chairman and Ranking Member. Thank you for the 
opportunity to testify about what happened and what has changed 
regarding endoscopy procedures at the Department of Veterans Affairs 
(VA). Accompanying me today are Dr. James Bagian, Chief Patient Safety 
Officer; Nevin Weaver, Veterans Integrated Service Network (VISN) 8 
Director; Dr. Joseph Pellecchia, Interim Network Chief Medical Officer 
and Chief of Staff, Huntington VA Medical Center; Lawrence Biro, VISN 7 
Director; Dr. John Vara, Chief of Staff at the Miami VA Medical Center; 
Juan Morales, Director of the Tennessee Valley Healthcare System; 
Rebecca Wiley, Director of the Charlie Norwood (Augusta) VA Medical 
Center; and Mary Berrocal, Director of the Bruce W. Carter VA Medical 
Center.
    My testimony today will provide a brief background on endoscopic 
devices, explain what happened at four of our facilities, describe 
changes VA instituted at the local level, report on new national 
policy, and discuss future actions.
    The Department of Veterans Affairs' number one priority is the 
well-being of our Nation's veterans. VA deeply regrets these incidents 
occurred. We are an organization that is accountable to veterans.
    VHA is committed to being people-centric, results-driven, and 
forward looking to create an organization that is equipped for the 21st 
century. We will use this unfortunate experience to understand how we 
can transform our Department.
    Our veterans were willing to make the ultimate sacrifice and they 
deserve the best possible care, at every facility that we operate. We 
have an obligation to provide them a safe environment in which to get 
medical care. Veterans and their families need to know when they come 
to VA they are in good hands and that they are being provided the best 
care in the country and they need not fear the VA health care system, 
it is one of the best in the Nation. As this incident shows, however, 
we must never rest on our laurels, and always remain diligent stewards 
of leading health care initiatives and services.
    Secretary Shinseki has made accountability and transparency a top 
priority for VHA and for the entire Department. It is unacceptable that 
this has happened and the Secretary has insisted that we take 
aggressive action to inform, test and support our patients. We are a 
results-driven organization that learns from our mistakes. Everyday we 
need to push ourselves to better treat, serve and provide for our 
clients--veterans.
    The Secretary has demanded that we continue to rigorously monitor 
this situation. Our next step is to utilize the findings of these 
investigations to implement any necessary corrective actions in a firm, 
but responsible fashion. We must continue to provide an environment 
that encourages all disclosures that impact the care and safety of our 
veterans.
    I hope our testimony today will provide the necessary background 
information to explain what happened at our facilities, describe 
changes VA has instituted, report on new national policy, and discuss 
future actions.
    In relation to the inadequate processing of endoscopes, that is, 
those steps taken to disinfect at a high level endoscopic equipment and 
prepare it for further use, VA has taken local and national actions to 
better understand how this could happen and to ensure it does not 
happen again. We are committed to an open and honest assessment of our 
policies and procedures. While we do not ever want to worry patients 
unnecessarily, we believe patients have a right to know about important 
information that could potentially affect their health. VA's policy 
requires disclosure to patients of any adverse events related to their 
health care that causes or may potentially cause harm. VA has notified 
patients about even those events that may not be obvious or severe or 
those that pose only a minimal risk to a patient's health. The 
probability that anyone was harmed as a result of our inadequate 
reprocessing at these four facilities is very low.
    Because of the quality and patient safety programs VA has built 
over the past several years, we discovered the problem, identified the 
patient population at risk, proactively notified them, and began robust 
testing, counseling and treatment. The reprocessing issues identified 
at our facilities were identified and announced by VA, not by an 
outside group. We have kept Veterans Service Organizations, the media, 
and Congress informed about this issue.
    The disclosures we are making to veterans are based on the very 
small potential for harm. At present, there is no definitive evidence 
to suggest that the positive tests we have found so far are the result 
of inadequate reprocessing of endoscopy equipment. In this country, 
many adults who are infected with Human Immunodeficiency Virus (HIV), 
Hepatitis B and C have not been tested and would not be aware that they 
are infected. In recent weeks VA has been testing many patients who 
have never been tested before. As a result, we would expect some of 
these patients would test positive. No matter how low the likelihood 
that any disease occurred due to suboptimal scope disinfection, VA will 
care for patients regardless of the source of infection.
    We are aware there were other facilities identified with potential 
issues, but we determined that the risk of harm to patients at these 
facilities was so remote that it did not justify informing patients.
Background
    Endoscopes are small diameter devices that allow a physician to see 
internal organs through external orifices by utilizing a system of 
optics. There are many different types of flexible and rigid 
endoscopes. The endoscopes discussed below are inserted either through 
the nose or mouth to visualize the esophagus, nasal passages, lung, 
stomach and upper part of the small intestine, or they are inserted 
through the rectum to visualize the colon. Some of these endoscopes 
used for colonoscopies have an internal tube that allows the physician 
to inject a stream of water through the endoscope to flush away any 
material that might obstruct adequate visualization of the colon.
    Flexible endoscopes are complex devices that need to be reprocessed 
before they can be used again safely. Reprocessing procedures are 
defined by the endoscope manufacturer and generally involve careful 
cleaning of the entire external and internal surfaces with an 
appropriate cleaner, brushing any interior channels, and subjecting the 
entire scope to high level disinfection or sterilization as recommended 
in the manufacturer's instructions.
Discovering the Problems
    On Monday, December 1, 2008, at the Tennessee Valley Health Care 
System, Alvin C. York (Murfreesboro) VA Medical Center (VAMC) in 
Tennessee, VA staff observed during the third endoscopic colonoscopy of 
the day a discoloration in the tubing that supplies water to flush the 
colonoscope. They immediately realized that this presented a potential 
problem to the patient and investigated further. Over the next 2 days, 
staff determined they were not using a water irrigation tube with a 
check valve designed to prevent contaminated fluid from the patient 
from flowing back into the scope and irrigation water tubing. As they 
investigated further, the staff discovered the Auxiliary Water Tube 
(MAJ-855) had been altered with a different connector that was not a 
one-way valve. In the process of examining the procedures for the use 
and reprocessing of the colonoscope, the Murfreesboro staff discovered 
that they were not changing and reprocessing the MAJ-855 in accordance 
with the manufacturer's instructions.
    The Murfreesboro staff reported these problems to the facility 
Patient Safety staff on December 4, 2008, and the next day, to VA's 
National Center for Patient Safety (NCPS). NCPS conducted fact finding 
by evaluating the equipment and procedures used at Murfreesboro and by 
closely working with the endoscope manufacturer.
    Based on this work, a Patient Safety Alert (AL09-07) was issued to 
the entire VA system on December 22, 2008. This alert requested that 
all facilities determine they were using the correct valve and also 
stressed that the manufacturers' instructions for all endoscopes were 
to be exactly followed regardless of the brand. All facilities were 
directed to determine if manufacturers' instructions were followed in 
the use or reprocessing of flexible endoscope tubing and accessories 
and to report any deviations to VA Central Office by January 7, 2009. 
As a result of this alert, in early January 2009, 16 additional 
facilities reported they had in some way not reprocessed their 
endoscope water flushing systems in accordance with the manufacturers' 
instructions.
    It must be emphasized that failure to follow a manufacturer's 
instructions does not necessarily result in significant additional risk 
of cross contamination because the equipment is designed to have 
redundant safety features. With this in mind, NCPS contacted the 
manufacturer, which conducted tests to clarify what additional clinical 
risk might accrue from the failure to follow its instructions. As a 
result of these clinical and lab based tests, the VHA Clinical Risk 
Assessment Advisory Board (CRAAB) determined there was no appreciable 
additional risk of cross-contamination if the only practice was 
incorrect reprocessing of the MAJ-855 between patients. This 
determination was made on February 6, 2009, following receipt of 
results of the manufacturer's clinical tests. The CRAAB is a 
multidisciplinary committee that makes recommendations to the Principal 
Deputy Under Secretary for Health (PDUSH) as to clinical risk and 
whether large scale notifications (disclosure) should be made to 
veterans.
    The CRAAB concluded there was a very small risk of cross-
contamination if the MAJ-855 was not reprocessed between patients and 
either (1) the proper check valve was not attached to the MAJ-855; or 
(2) the clinician did not prime the MAJ-855 with water prior to 
initiating the examination. Following the February 6, 2009, meeting, 
the CRAAB, therefore, recommended disclosure only where either of these 
two circumstances existed in addition to improper reprocessing of the 
MAJ-855. Of the 17 VAMCs reporting noncompliance with manufacturers' 
instructions, these circumstances existed only at Murfreesboro and 
thus, the CRAAB only recommended disclosure to patients at this 
facility.
    VA has a formal process to evaluate clinical risks to patients when 
a risk, and hence the need for disclosure, is not clear. The CRAAB 
weighs the nature of the harm, the probability, severity, magnitude and 
duration of the harm, and courses of action, and balances these factors 
against the potential medical, social, psychological or economic 
benefits or burdens to veterans resulting from the disclosure itself.
    On January 26, 2009, the Augusta VAMC informed VA Central Office of 
a problem it discovered with reprocessing of their Ear, Nose and Throat 
(ENT) scopes. These scopes are different from the colonoscopes used at 
Murfreesboro. As a result of a personnel change in January 2008, ENT 
scopes were not reprocessed in accordance with the manufacturer's 
instructions. After reviewing the circumstances, the PDUSH decided that 
potentially exposed patients should be informed.
    To ensure all Veterans Health Administration (VHA) facilities were 
reprocessing endoscopic medical equipment correctly, on January 28, 
2009, the Deputy Under Secretary for Health for Operations and 
Management issued a memorandum requiring all VA medical centers 
performing any endoscopic procedures to conduct a review of the set up 
and reprocessing of these devices. On February 9, 2009, the Under 
Secretary for Health instructed all medical centers to conduct a safety 
Step-Up Week during March 9 through 13, 2009, to focus facilities on 
retraining staff on the proper use of all endoscopy equipment, 
establishing easily tracked accountability chains for instrument 
cleaning, and training all appropriate staff about standard operating 
procedures.
    On February 24, 2009, Mountain Home VAMC reported that ENT 
endoscopes were not reprocessed in accordance with manufacturer's 
instructions. On February 27, 2009, after reviewing the facts with the 
facility and a group of experts, the PDUSH decided that disclosure to 
patients was required. The facility notified its local congressional 
delegation, local Veterans Service Organizations, and veterans at 
potential risk.
    On March 4, 2009, in preparation for the Step-Up Week, staff at the 
Miami VA Medical Center discovered they had erroneously reported in 
January they were in compliance with the manufacturer's instructions. 
Miami staff found that the water irrigation tubing was not correctly 
reprocessed and that it was not consistently primed and flushed prior 
to the start of the patient examination. While either one of these 
omissions by themselves would not have resulted in increased risk to 
patients, both practices together created a slightly increased 
potential for cross contamination between patients. The CRAAB 
recommended disclosure to affected veterans, and the PDUSH agreed.
    The official policy of the Veterans Health Administration is that 
``VHA facilities and individual VHA providers have an ethical and legal 
obligation to disclose to patients adverse events that have been 
sustained in the course of their care, including cases where the 
adverse event may not be obvious or severe, or where the harm may only 
be evident in the future.''
    As a result of increased scrutiny of the reprocessing of medical 
equipment within VHA, 10 VA medical centers, in addition to the 17 
originally identified, have found reprocessing practices that were not 
in compliance with manufacturer's instructions. Each facility where we 
found a problem, we evaluated the situation to determine if 
notification was required.
Local Response
    Each of the four medical centers mentioned above took prompt action 
to notify possibly affected veterans; to offer testing, counseling and 
needed treatment; and to identify and implement necessary procedural 
changes to ensure the issues would not develop again. Other changes 
varied among medical centers and are discussed below. Specifically, 
each VAMC:

      Identified veterans who received endoscopic colonoscopies 
or esophageal studies during the applicable date range and sent them 
letters by regular or certified mail, return receipt requested. The 
letters informed the veteran they were potentially at risk and offered 
testing for Hepatitis B, C, and HIV infection. Hepatitis B, C and HIV 
were identified as the significant viral conditions which have the 
potential to be transmitted via endoscopic cross-contamination. The 
letter provided a toll-free telephone number to call to answer 
questions or schedule testing.
      Established and staffed call centers to respond to 
questions from veterans.
      Established systems to track veterans who were notified 
and tested.
      Established clinics to provide, on a priority basis, 
testing and treatment as appropriate.
      Instituted changes in staffing and processes as necessary 
to ensure endoscopic equipment would be properly reprocessed according 
to manufacturer's instructions.

    At the Murfreesboro campus, staff identified 6,805 veterans in 
initial reports as having received colonoscopies between April 2003, 
when VA first began using the affected equipment, and December 2008, 
when VA discovered the issue. After conducting an intensive medical 
record review to ensure all potentially affected veterans were 
identified, VA added 418 patients to the list for notification. VA 
completed certified mailings to the first group by February 13, 2009, 
while the second group was notified by certified letters sent May 8, 
2009. Murfreesboro VAMC continues to search for veterans whose letters 
have been returned. The staff is using additional databases and general 
Internet searches. VA is closely monitoring the results of this 
outreach, and the records will continue to be updated. My oral 
statement will include the most current information. As part of its 
participation in the national Step-Up Week in March 2009, the 
Murfreesboro VAMC conducted an intensive review of the procedures for 
reprocessing of all reusable medical equipment (RME), ensuring they 
complied with manufacturers' reprocessing instructions. It also 
conducted a Root Cause Analysis to identify and understand all 
components of this issue, validated standard operating procedures 
(SOPs), confirmed training of all clinical and support staff, and 
verified staff competencies.
    At the Mountain Home VAMC, staff identified 297 veterans as 
possibly affected by improper endoscope reprocessing that was not in 
strict compliance with the manufacturers' instructions. All 
laryngoscopes are now reprocessed by the facility's Supply, Processing 
and Distribution (SPD) program. The facility has updated policies to 
require better coordination among departments when RME is purchased and 
SOPs are written. All staff members responsible for handling RME are 
trained and certified. Training is noted in each competency checklist 
prior to actual operations. Supervisors are responsible for maintaining 
competency checklists and periodically validating adherence to 
standards. All facility SOPs are aligned with the manufacturers' 
written instructions.
    At the Augusta VAMC, staff identified 1,069 veterans who received 
ENT procedures between January and November 2008. VA completed an 
initial mailing of letters to these veterans by February 10, 2009. 
Additionally, VA released public service announcements with the help of 
local media to further increase awareness among veterans and family 
members. VA staff called veterans who had not contacted the VAMC in 
response to the initial mailing. At the end of March 2009, VA sent 137 
certified letters to patients who still had not made contact in 
response to the initial mailing or who could not be reached by phone. 
Of those letters, 128 were successfully delivered, one was declined, 
and six were returned. Of the six returned letters, one was identified 
as not deliverable because the patient was deceased. As of May 29, 
2009, all but five of the 1,069 patients in the risk pool have received 
mail notification, and we are continuing to attempt to locate these 
five patients.
    Augusta VAMC also conducted a Root Cause Analysis and, based on its 
findings, took the following steps to improve medical equipment 
reprocessing. First, reprocessing of RME was consolidated into the SPD 
function. Construction also began on a new SPD station near the 
gastrointestinal endoscopy suite. A multidisciplinary task force 
ensured the ready availability of manufacturers' instructions for 
reprocessing and that SOP and staff competency checklists matched those 
instructions, revising where needed. VA re-trained all staff involved 
in RME reprocessing and evaluated them using competency checklists. 
Finally, the facility also increased use of the SPD Observational 
Assessment Tool from once per year, as nationally required, to once a 
month to ensure continued compliance with all requirements.
    At Miami VAMC, VA identified a total of 2,609 veterans through 
medical record searches and reviews as having been possibly at risk for 
cross contamination. VA began mailing notifications to all affected 
veterans March 23, 2009. After checking other databases for address 
updates or changes, the facility sent a second certified mailing to 
veterans whose first letters were returned as undeliverable. Miami has 
a particularly mobile population, so the facility undertook additional 
efforts to locate veterans who could not be notified by mail. These 
measures included searches for alternate addresses on other VA 
databases and commercial Web sites and multiple visits to homeless 
shelters in the Miami area. The facility continues to attempt to locate 
and notify remaining potentially affected veterans.
    Miami also reorganized its SPD program and realigned executive 
leadership and line managers to make them accountable for reprocessing 
activities. The facility added a Clinical Nurse Specialist to enhance 
clinical knowledge in the line management function. They also reviewed 
and revised competency definitions for all employees assigned to the 
gastrointestinal clinic or to SPD to address proper equipment handling, 
maintenance, use, and cleaning. VA conducted extensive training for 
gastrointestinal technicians and nurses in proper equipment set-up and 
pre-cleaning practices. Some of this training was done by 
manufacturers' representatives, while some was done by sending staff to 
other VA medical centers. Facility leadership verified the competencies 
of all SPD staff responsible for endoscope cleaning by April 7, 2009. 
Beyond this, the facility established a continuing education plan, 
including professional certification activities. By enhancing quality 
management committees and establishing a VISN-level team responsible 
for conducting unannounced inspections, VA continues to exercise 
effective oversight of facilities and to preserve patient safety.
VA's National Response
    VA has taken a number of steps nationally to identify and correct 
shortfalls with the proper set up, use, reprocessing, and maintenance 
of reusable endoscopy equipment at all other VA medical facilities.
    The Safety Step-Up Week and the series of communications to the 
field (including memos, the patient safety alert, and reminders on 
national calls and at national meetings) alerted all facilities about 
potential problems with endoscope processing and training. Facilities 
have been given an opportunity during national calls to inform other 
facility leaders about what they have learned concerning the discovery 
of problems, patient disclosures, or best practices.
    VHA developed, published and implemented a national directive 
(Veterans Health Administration Directive 2009-004, dated February 9, 
2009, ``Use and Reprocessing of Reusable Medical Equipment (RME) in 
Veterans Health Administration Facilities''). Cornerstones of the 
directive are:

      Assigning responsibilities, especially at the front line 
level with Network and Facility Directors, but also with key staff 
within each medical facility;
      Requiring oversight programs be established, including 
unannounced site audits and quality assurance processes;
      Requiring through policy that manufacturers' instructions 
for the use, reprocessing, and maintenance of RME must be obtained and 
followed. These instructions must be used to develop local standard 
operating procedures and have them available for use by staff; and
      Requiring staff training and assessing staff competency 
to ensure manufacturers' instructions are being followed correctly.

    VA's national SPD program has developed several training courses to 
increase the professionalism and education of field SPD employees. For 
example, VHA has developed a 5-day course, which includes a national 
SPD Certification Test, for new SPD staff, particularly front-line 
technicians. SPD Chiefs, Assistants and Supervisors can take a 3-day 
seminar, and managers who supervise Chiefs of SPD can take a different 
3-day class. A new 3-day class is available for new SPD Chiefs and 
Assistant Chiefs. The VHA National Infectious Diseases Program and 
Employee Education System have produced one educational video for 
reprocessing endoscopes, distributed it to medical facilities and is 
completing the production of another video.
    Oversight of SPD is accomplished by both internal and external 
mechanisms. First, a national SPD Self-Evaluation involves each 
facility analyzing its SPD-related activities twice a year. A 
facility's performance is judged in part on the results of this 
evaluation. Second, the National SPD Quality Management Observational 
Assessment Tool (SPD Tool) was conducted in fiscal years (FY) 2007 and 
2008 and is being repeated this fiscal year. VA distributed the SPD 
Tool to VISNs and facilities in May for completion. The SPD Tool 
requires a four-person team at each medical facility to directly 
observe staff members reprocessing cytoscopes, colonoscopes, 
bronchoscopes, and upper GI endoscopes. Low outliers identified by this 
SPD Tool are scheduled for special site visits. One of the 
recommendations of the FY 2008 SPD Tool was to establish and fill 
Assistant Chief of SPD positions at all Complexity Level 1 
facilities.\1\ All Complexity Level 1 and 2 facilities have been 
directed to establish these positions, and facilities are working to 
establish and fill them. These positions will assist with the oversight 
of reprocessing activities that occur both inside and outside of SPD. 
Finally, the National SPD Site Review Program also sends a site review 
team each year to one-third of VHA facilities. Areas reviewed by the 
site review team include the SPD department and areas outside SPD where 
medical equipment reprocessing occurs.
---------------------------------------------------------------------------
    \1\ There are five levels of complexity: 1a, 1b, 1c, 2 and 3, in 
descending order of complexity. VA determines facility complexity based 
upon a formula that considers the patient population, the patient risk, 
the level of intensive care unit and complex clinical programs, as well 
as education and research indices.
---------------------------------------------------------------------------
Future Actions
    VA has several initiatives underway to improve SPD and ensure it 
becomes a high reliability production environment. We are working to 
make SPD compliant with International Organization for Standardization 
(ISO) 9001, which is widely considered to be the standard for quality 
management systems. In addition, a workgroup continues to investigate 
ways to standardize the brands and models of endoscopes used in a 
particular facility, which will simplify reprocessing protocols and 
training needs. The workgroup is also evaluating leasing options that 
will provide repair, maintenance and training services. VA has issued a 
request for information (RFI) for a software solution for SOP 
management that can also be used for competency verification and 
document control. VA expects such software will facilitate 
automatically transmitting any changes to the manufacturers' 
instructions to users and verifying receipt of these changes. We are 
also developing a new directive that will align SPD at each medical 
center under the facility Chief of Staff. Standardizing organizational 
alignment will simplify communication lines from VA Central Office to 
the field and vice versa. It will also enhance clear lines of authority 
and responsibility for the SPD function.
    To better understand any possible connection between newly 
discovered chronic blood borne infections and reports of possible 
improper reprocessing of endoscopy equipment, VA has assembled a team 
of subject matter experts to conduct a detailed epidemiologic 
investigation, starting with an extensive review of electronic medical 
records. The review encompasses all recent and prior testing for HIV, 
Hepatitis B, and Hepatitis C, as well as other relevant laboratory test 
results (e.g. liver function tests); medical histories and risk factors 
for each of the three viral infections; and details of the actual 
procedures. The team will also review the sequence of patients 
receiving endoscopic exams, to assess whether a veteran previously 
diagnosed with one of the three viruses preceded a newly-diagnosed 
veteran on a daily examination schedule. It is very important to note 
that, even when completed, this study will not be able to demonstrate 
causality. However, it will be able to answer the following questions:

      Have all positive test results for HIV, Hepatitis B and C 
been confirmed? Are there any false positives?
      Is there evidence that any veteran with a positive post-
endoscope test was infected prior to their endoscopic procedure, but 
never diagnosed?
      Can we identify whether a patient who was previously 
diagnosed with HIV or Hepatitis had an endoscope procedure the same day 
as a veteran who is now newly diagnosed with these viruses?

    It is expected that the first phase of this investigation will take 
several weeks, to permit review of relevant charts and completion of 
any additional blood work. We will share the results with the Committee 
when it is available. Additional analyses will need to be performed 
after the remaining patients exposed have been tested.
    Very limited information exists in the medical literature that 
could elaborate or quantify the known risks associated with 
reprocessing of endoscopy equipment. One long-term review (1970 through 
2003) examined health care associated infections related to 
gastrointestinal endoscopy and found 281 transmitted infections.\2\ 
Major reasons for endoscope-related infections from this study were 
inadequate cleaning, improper selection of a disinfecting agent, 
failure to follow recommended cleaning and disinfection procedures, and 
flaws in endoscope design or automated endoscope reprocessors. Failure 
to follow established reprocessing guidelines has continued to result 
in infections associated with gastrointestinal endoscopes.\3\
---------------------------------------------------------------------------
    \2\ Seoane-Vazquez E. et al. (2007). Endoscopy-related infections 
and toxic reactions: an international comparison. Endoscopy 39(8): 742-
78.
    \3\ See ibid.
---------------------------------------------------------------------------
    Flexible endoscopes are particularly difficult to disinfect and 
easy to damage because of their intricate design and delicate 
materials. Meticulous cleaning must precede any sterilization or high 
level disinfections of these instruments. Failure to perform thorough 
cleaning can result in sterilization or disinfection failure, and 
outbreaks of infection can occur.\4\ Because of the large variety of 
types and models of endoscopic equipment, a single, standard process 
for reprocessing all reusable endoscope equipment does not exist. This 
equipment is also constantly being updated, improved, and changed. Our 
responsibility for effective maintenance and disinfection is further 
complicated by the growing plethora of equipment, as each type of 
equipment or each piece and component requires unique reprocessing 
techniques. The leasing option described above is one approach to 
improving SPD and should help address this concern.
---------------------------------------------------------------------------
    \4\ See Seoane-Vazquez E., Rodriguez-Monguio R. (2008). Endoscopy-
related infection: relic of the past? Curr Opin Infect Dis; 21(4): 362-
6.
---------------------------------------------------------------------------
    A recent article summarized the information available in the 
scientific literature about endoscopy-related exogenous infections (an 
infection having a cause from outside the body) or pseudo-infections 
(where patients may have a positive test result but do not develop 
clinical symptoms). The article identified 140 outbreaks during the 
period 1974 through 2004, roughly half of which occurred in the United 
States and half elsewhere.\5\ Overall, the risk of infection due to 
inadequate endoscope reprocessing is reported as very low.\6\
---------------------------------------------------------------------------
    \5\ See ibid.
    \6\ See nn 2, 4, ibid; also Schembre D.B. (2000) Infectious 
Complications Associated with Gastrointestinal Endoscopy. 
Gastrointestinal Endoscopy Clinics of North America; 10(2): 215-231.
---------------------------------------------------------------------------
Conclusion
    In conclusion, I would like to say that I know we have not answered 
all your questions, but we have come here today to be open, honest and 
to report on an issue of grave importance to us. Although the risk of 
cross contamination and exposure to infections is exceptionally low, we 
are notifying all potentially affected veterans and treating those 
testing positive regardless of cause.
    When we identified a problem related to the reprocessing of 
endoscopy equipment, we took aggressive actions and voluntarily 
disclosed the information. From the start, our intention has been to do 
what is best for the veterans. We know that we have made a mistake and 
necessary corrective actions will be taken.
    VHA is committed to being a veteran-centric organization that 
continues to improve the services we provide the men and woman who have 
sacrificed for our country. Our sole purpose is to make sure that we 
put veterans and their care first.
    We are proud of the fact that VA health care is widely regarded as 
among the best in the country, but we know that we are not perfect and 
have many things we can improve.
    By the end of fiscal year 2008, more than 7.8 million veterans were 
enrolled for care and almost 5.6 million of them were receiving care. 
VA provided more than 67 million outpatient visits last fiscal year 
alone. Our aim is to ensure every encounter is a positive and safe one 
for our patients. It is our duty and honor to serve America's veterans 
and provide them the highest quality health care.
    Thank you again for the opportunity to testify. My colleagues and I 
are prepared to answer your questions.

                                 
                    Statement of Hon. Cliff Stearns,
         a Representative in Congress from the State of Florida
    Thank you, Mr. Chairman.
    Thank you for holding this very important hearing. Our Nation's 
veterans come to the VA for some of the best care in the country, so it 
was very alarming for me as a Senior Member of this Committee to learn 
that VA medical facilities have not been complying with multiple 
directives to ensure the endoscopic equipment they use is properly 
reprocessed and sterilized, and that as a result, many of our veterans 
have been put at serious risk. Like the thousands of veterans who could 
have been harmed by this negligence, I too have many questions and I 
hope today's hearing affords us the chance to have a frank and honest 
discussion about what happened and what the VA is going to do to ensure 
this never happens again.
    Placing our veterans at risk to be inadvertently exposed to blood 
born pathogens such as Hepatitis and HIV via improper use of endoscopy 
equipment is completely unacceptable. The numbers reported from the 
medical centers at fault in Miami, Augusta, and Murfreesboro are truly 
disturbing: over 10,000 patients have been put at risk at these 3 
facilities with 53 reported cases thus far. Thirteen veterans have been 
diagnosed with Hepatitis B, 34 with Hepatitis C, and 6 with HIV. And 
while we will never really know if these veterans contracted these 
diseases because of the improper use of the equipment and lack of 
proper sterilization, or if these diseases were present in the body 
prior to the procedures, it is pertinent that the VA provide 
comprehensive care for all of these patients regardless of the source 
of the infection.
    We must put ourselves in the shoes of these veterans and imagine 
what it would be like to have received a letter from the VA notifying 
you that you could have been inadvertently exposed to diseases such as 
Hepatitis and HIV while undergoing a procedure that is designed to 
ensure you are healthy. No veteran should ever have to receive such a 
letter, and no veteran should ever have to worry about the quality of 
care they receive at a VA medical facility.
    Clearly, there is a systemic problem at the VA, or we wouldn't be 
here today. The VA needs standardized reprocessing procedures for all 
of its medical centers and these procedures should not be open to the 
interpretation of the medical staff. Additionally, the management and 
communication at all VA medical centers needs to be improved.
    I, therefore, look forward to hearing from our two panels today, 
and I hope that we can leave this hearing feeling confident in the VA's 
plan to ensure all of its medical centers are complying with proper 
procedures from here on out and the VA as a whole fosters a culture 
that encourages honesty and an environment that ensures the safety of 
our veterans.

                   MATERIAL SUBMITTED FOR THE RECORD

                                     Committee on Veterans' Affairs
                                                    Washington, DC.
                                                     March 25, 2009

The Honorable George Opfer
Inspector General
Department of Veterans Affairs
Washington, D.C. 20420

Dear Mr. Opfer:

    On February 4, 2009, the Department of Veterans Affairs released a 
Memorandum to all facility directors to conduct an ``Endoscopy Step-Up 
Week,'' March 8-14, 2009.
    I am concerned that Miami VAMC has not adequately supervised the 
training at their facilities. Therefore, I request a detailed review 
into the Miami VA Medical Center on their ``Step-Up'' training and 
reprocessing procedures on endoscopic equipment used in diagnosing and 
treating veterans.
    I am also concerned there may be a systemic problem throughout VA 
Medical Centers in meeting the ``Step-Up'' training requirements as 
directed in the February 4, 2009 memorandum. I strongly request a VA 
wide review of all endoscopic procedures.
    Please contact either Art Wu or Dolores Dunn at 202-225-3527 if you 
have any questions in this regard.

                                                        Steve Buyer
                                          Ranking Republican Member

                                 

                                U.S. Department of Veterans Affairs
                                                    Washington, DC.
                                                      July 23, 2009

The Honorable Harry E. Mitchell
Chairman, Subcommittee on Oversight and Investigations
Committee on Veterans' Affairs
United States House of Representatives
Washington, DC 20515

Dear Mr. Chairman:

    This is in response to a question at the Subcommittee's June 16, 
2009, hearing on endoscopy procedures at the U.S. Department of 
Veterans Affairs on whether water pumps used in colonoscopes could be 
used with other types of endoscopes.
    After consulting with a leading manufacturer of colonoscopes and 
endoscopes, it became clear that water pumps are approved by the Food 
and Drug Administration for specific use with specific endoscopy 
equipment. In general therefore, water pumps are not interchangeable 
between different models of scopes. There may, however, be specific 
cases where the same model water pump is approved for use with a 
variety of endoscopes.
    This information has also been provided to Congressman David P. 
Roe, Ranking Republican Member, Subcommittee on Oversight and 
Investigations.

            Sincerely,

                                                    GEORGE J. OPFER
                                                  Inspector General

                                 

                                     Committee on Veterans' Affairs
                       Subcommittee on Oversight and Investigations
                                                     Washington, DC
                                                      June 24, 2009

Honorable Eric K. Shinseki
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Secretary Shinseki:

    Thank you for the testimony of William E. Duncan, M.D., Ph.D., 
MACP, Associate Deputy Under Secretary for Health for Quality and 
Safety, Veterans Health Administration, U.S. Department of Veterans 
Affairs, accompanied by: James P. Bagian, M.D., PE, Chief Patient 
Safety Officer, National Center for Patient Safety, Veterans Health 
Administration, U.S. Department of Veterans Affairs, Nevin Weaver, 
FACHE, Director, VA Sunshine Healthcare Network, VISN 8, Veterans 
Health Administration, Lawrence A. Biro, Director, VA Southeast 
Network, VISN 7, Veterans Health Administration, Joseph Pellechia, 
M.D., FACP, Interim Network Chief Medical Officer and Chief of Staff, 
Huntington VA Medical Center, Veterans Health Administration, John R. 
Vara, M.D., Chief of Staff, Miami VA Healthcare System, Veterans Health 
Administration, Juan A. Morales, RN, MSN, Director of the Tennessee 
Valley Healthcare System, Veterans Health Administration, Rebecca J. 
Wiley, Director of the Charlie Norwood VA Medical Center, Veterans 
Health Administration, and Mary Berrocal, MBA, Director of the Miami VA 
Healthcare System, Veterans Health Administration, U.S. Department of 
Veterans Affairs at the U.S. House of Representatives Committee on 
Veterans' Affairs Subcommittee on Oversight and Investigations hearing 
that took place on June 16, 2009 on ``Endoscopy Procedures at the U.S. 
Department of Veterans Affairs: What Happened, What Has Changed?''
    Please provide answers to the following questions by Wednesday, 
August 5, 2009, to Todd Chambers, Legislative Assistant to the 
Subcommittee on Oversight and Investigations.

    1.  What is VA doing to assist those veterans who have been tested 
and found positive for various infections as a result of the incidents 
in Murfreesboro, Tennessee, Miami, Florida and Augusta, Georgia?
      a.  Please explain the nature and type of support, and care the 
VA will provide those veterans that have tested positive for Hepatitis 
B, Hepatitis C, and HIV.

    2.  What number of veterans that have tested positive for Hepatitis 
B, Hepatitis C, and HIV have filed Form 95s?
      a.  What actions has VA taken to inform the veterans who have 
tested positive as to their rights in bringing legal action against VA?

    3.  In the VA OIG's testimony, the OIG discussed the unannounced 
inspection of colonoscopy and ENT reprocessing sites within VA medical 
facilities testing compliance with the VHA directive, VHA Directive 
2009-004. The OIG estimated that only about one out of two colonscope 
reprocessing units were in compliance with the requirement to ensure 
demonstrated competency and endoscope reprocessing by employees at 
these sites, and that 43 of the reprocessing sites had both 
demonstrated competencies. What actions are in place to ensure 
compliance increases throughout VHA?
      a.  What actions has VA taken to ensure compliance with the 
relevant directives regarding endoscope reprocessing?
      b.  When will VA review the VHA organizational structure and make 
the necessary changes to implement quality controls and ensure 
compliance with directives?
      c.  When will the changes be executed and how will VA ensure that 
the changes are executed at every VHA facility?

    4.  The AIB chartered to review the issues in Miami found serious 
problems with: inventory control, oversight, supervision, training, 
communication, and competence assessment related to endoscopy 
equipment. Which one of these serious problems listed is the greatest 
concern to the VA and why?
      a.  What actions have you taken to improve each of the AIB 
concerns?

    5.  How can the Patient Safety Alert system at every VISN and 
Medical Center be improved and what actions have been taken to further 
this end?

    6.  Please provide the Committee the results of the 2007 and 2008 
self-assessment survey, a list of all names of all VHA senior managers 
who were briefed on the results, and what remedial actions were 
recommended, as well as a timeline for implementation of these remedial 
actions to be completed.

    7.  What metrics does the VA plan to utilize in order to measure 
the effectiveness of compliance with the International Organization for 
Standardization (ISO 9001), and when does VA plan to implement ISO 
9001?

    8.  Please provide a report back to the Committee on what 
endoscopes are currently being utilized at the various VA facilities, 
how many of these endoscopes can be equipped with disposable tubing, 
and if there would be any benefits in either cost savings or patient 
safety in moving toward the use of disposable tubing.

    9.  Please detail the methodology VA is implementing to assure 
continued training and competencies of staff responsible for cleaning 
and sterilizing all medical equipment, including scopes and endoscopes.

    10.  What coordination has been done between VA and the Department 
of Health and Human Services to share information regarding patient 
safety alerts on this issue, as well as other issues that have arisen 
in the treatment of veterans at the VA?

    Thank you again for taking the time to answer these questions. The 
Committee looks forward to receiving your answers. If you have any 
questions concerning these questions, please contact Subcommittee on 
Oversight and Investigations Majority Staff Director, Martin Herbert, 
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur 
Wu, at (202) 225-3527.

            Sincerely,

HARRY E. MITCHELL
                                                       DAVID P. ROE
Chairman
                                          Ranking Republican Member

MH/tc

                               __________
                        Questions for the Record
               The Honorable Harry E. Mitchell, Chairman
         The Honorable David P. Roe, Ranking Republican Member
              Subcommittee on Oversight and Investigations
                  House Committee on Veterans' Affairs
                             June 16, 2009
    Endoscopy Procedures at the VA: What Happened, What Has Changed?
    Question 1: What is VA doing to assist those Veterans who have been 
tested and found positive for various infections as a result of the 
incidents in Murfreesboro, Tennessee, Miami, Florida and Augusta, 
Georgia? Please explain the nature and type of support and care the VA 
will provide those Veterans that have tested positive for Hepatitis B, 
Hepatitis C, and HIV.

    Response: While reviews indicate that the risk of transmission of 
Hepatitis B and Hepatitis C virus as a result of endoscopy procedures 
is extremely small, and that transmission of human immunodeficiency 
virus (HIV) through endoscopy has never been reported, the Department 
of Veterans Affairs (VA) is providing appropriate counsel and 
individualized care for those veterans that have tested positive no 
matter what the source of their infections may be. Their care is 
individualized to meet their needs with referrals to the appropriate 
clinic for treatment and ongoing care, including any other support they 
may need as a result of their new diagnosis. This includes referrals to 
sub-specialists such as hepatologists and infectious disease 
specialists for appropriate care within VA guidelines for the 
individual illness. Providers caring for these veterans have clinical 
expertise and experience to prescribe and monitor treatment regimens. 
Additionally, these veterans are also being offered the following:

    1.  Mental health counseling and support service;
    2.  Individual and personalized counseling with a special care 
coordinator (or the veteran's primary care provider at the veteran's 
request);
    3.  Consultations with specialists in infectious diseases and 
hepatology;
    4.  Family education and support;
    5.  Chaplain services;
    6.  Social work services;
    7.  Referrals to internal and external support groups;
    8.  Ongoing monitoring of clinical condition with appropriate 
diagnostics; and
    9.  An individualized treatment plan to meet the veteran's 
conditions, needs, and wishes

    Question 2(a): What number of veterans that have tested positive 
for Hepatitis B, Hepatitis C, and HIV have filed Form 95s?

    Response: As of July 27, 2009, 13 veterans who have tested positive 
for Hepatitis B, Hepatitis C, or HIV have filed Form 95s 
(administrative tort claims under the Federal Tort Claims Act).

    Question 2(b): What actions has VA taken to inform the veterans who 
have tested positive as to their rights and bringing legal action 
against VA?

    Response: Augusta VA Medical Center (VAMC) has followed the 
procedure outlined in Veterans Health Administration (VHA) Directive 
2008-002, Disclosure of Adverse Events to Patients, which includes 
giving the patient information about eligibility for both 38 USC 1151 
claims for VA compensation and tort claims. Each patient who tested 
positive for various infections as a result of the look-back received a 
face-to-face meeting with either the chief of staff or the medical 
center epidemiologist. In these meetings, VA staff discussed the 
patient's test results, developed treatment planning relative to the 
patient's new diagnosis, and informed the patient of their rights 
regarding the tort claim process or application for VA compensation 
benefits under 38 USC 1151.
    Miami followed the procedure outlined in VHA Directive 2008-002, 
Disclosure of Adverse Events to Patients, which includes providing 
information to patients about eligibility for both 38 USC 1151 claims 
for VA compensation and tort claims. VA presented this information in 
multiple formats to reach the affected patient population to the 
greatest extent possible. Specifically, the facility used certified 
mailings, education sessions, handouts, home visits, and provider-
patient conferences. All patients who reported to the special care 
clinic at the Miami VA Healthcare System were provided with the General 
Counsel brochure entitled Adverse Event Frequently Asked Questions 
(FAQ), which describes patients' legal rights. The brochure also 
accompanied the second notification letters, which were mailed by 
certified delivery receipt. Patients were provided on-site education 
sessions that included discussion of patients' rights. Homeless 
veterans program social workers and home care nursing staff made visits 
to the last known addresses of the homeless veterans prior to the June 
13, 2009, outreach fair. The brochure was provided during those home 
visits as well.
    At Tennessee Valley, veterans testing positive were initially 
brought into the medical center for an appointment and were made aware 
of their test results. VA staff also discussed future plans for their 
care. Each veteran was personally contacted and informed of their 
options to either have a meeting for the purpose of disclosure, or, if 
they preferred, to receive information by mail to review. Either way, 
veterans received information on how to apply for both VA compensation 
under 38 USC 1151 and the process for filing a tort claim. They were 
also provided a copy of VA's Adverse Event FAQ.

    Question 3(a): In the VA OIG's testimony, the OIG discussed the 
unannounced inspection of colonoscopy and ENT reprocessing sites within 
VA medical facilities testing compliance with the VHA directive, VHA 
Directive 2009-004. The OIG estimated that only about one out of two 
colonoscope reprocessing units were in compliance with the requirement 
to ensure demonstrated competency and endoscope reprocessing by 
employees at these sites, and that 43 of the reprocessing sites had 
both demonstrated competencies. What actions are in place to ensure 
compliance increases throughout VHA? What actions has VA taken to 
ensure compliance with the relevant directives regarding endoscope 
reprocessing?

    Response: Each veterans integrated service network (VISN) has 
certified a VISN team has conducted an unannounced site visit to every 
facility where endoscopic procedures are conducted in its VISN by July 
17, 2009. This comprehensive review found that VHA facilities have made 
significant progress in providing a uniform process for pre-cleaning, 
cleaning and reprocessing of reusable medical equipment. Facilities 
submitted action plans for any areas that needed to be addressed and 
included target dates for completion. VA central office (VACO) staff 
with subject matter expertise in supply, processing and distribution 
(SPD) and reprocessing of reusable medical equipment, are carefully 
reviewing the findings and action plans from these VISN site team 
reviews to ensure the plans are reflective of the findings.
    Assisted by personnel from VA's National Center for Patient Safety 
and the Infectious Disease Program Office, the Office of the Medical 
Inspector has made a number of visits to medical centers to assist in 
their continued efforts to improve compliance with equipment specific 
re-processing standard operating procedures (SOP) and equipment 
specific competencies. The focus of these visits is to provide 
additional ``fresh eyes'' to review the medical center's actions to 
ensure adherence to VHA directives.

    Question 3(b): When will VA review the VHA organizational structure 
and make the necessary changes to implement quality controls and ensure 
compliance with directives?

    Response: VA is currently reviewing the organizational structure 
for reprocessing reusable medical equipment (RME). VHA issued Directive 
2009-031 on June 26, 2009, Improving Safety in the Use of Reusable 
Medical Equipment through Standardization of Organization Structure and 
Reprocessing Requirements, which drives several significant 
organizational changes. Each facility's nurse executive is now 
responsible for the day-to-day supervision of local supply processing 
and distribution (SPD--the area responsible for reprocessing medical 
equipment) operations and ensures the facility chief of SPD carries out 
their responsibilities as indicated within this directive. By September 
1, 2009, each VISN director must appoint a VISN SPD management board, 
which will be responsible for SPD oversight at the VISN level and the 
reprocessing of RME occurring within the VISN.

    Question 3(c): When will the changes be executed and how will VA 
ensure that the changes are executed at every VHA facility?

    Response: VHA Directive 2009-031 sets forth changes that are to be 
in place by September 1, 2009. The Deputy Under Secretary for Health 
Operations and Management's (DUSHOM) office was tasked with deploying 
and implementing this directive at all VISNs and facilities. A VISN-
level SPD management board is tasked with oversight to ensure that 
changes are executed at every facility within the VISN. The nurse 
executive has been designated as the person responsible for the local 
day-to-day operations at each facility and has a duty to ensure that 
changes are in place.
    An action plan has been developed in response to the Office of 
Inspector General's report, and is being reviewed by VHA senior 
leadership. The plan is centered on four core components: (1) 
implementing principled processes; (2) verifying compliance; (3) 
organizational design; and (4) reducing variability. The DUSHOM will 
work with the appropriate program offices to operationalize the plan 
and to ensure compliance in the field. The action plan as written 
consists of short-term (3-6 months), intermediate (6-12 months), and 
long-term (up to 24 months) components, that in all cases have specific 
programmatic and milestone accountability assigned.

    Question 4(a): The AIB chartered to review the issues in Miami 
found serious problems with: inventory control, oversight, supervision, 
training, communication, and competence assessment related to endoscopy 
equipment. Which one of these serious problems listed is the greatest 
concern to the VA and why?

    Response: VA plans to transform SPD patterned on an industrial 
model that incorporates processes found in International Standards 
Organization 9001 (ISO-9001) standards. VHA projects full 
implementation by July 1, 2011. The transformed SPD program will 
include the following:

      Demonstration of adherence to standards for management of 
SOPs, including rigid document control and review;
      Demonstration, documentation, and tracking of training 
and competencies through scheduled and unscheduled review; and
      Implementation of rigorous quality assurance and quality 
control programs to ensure high-reliability in all SPD processes.

    Uniform organizational alignment of SPD across VHA is crucial to 
ensuring the effective oversight of all reprocessing activities within 
medical facilities. A systematic approach involving representatives 
from infection control, patient safety, quality management, appropriate 
clinical service lines (e.g., gastroenterology and otolaryngology), and 
procurement/logistics personnel working collaboratively with the chief, 
SPD will ensure all personnel involved with reprocessing of RME have 
the necessary initial training, competency certification, and annual 
refresher training, and competency assessment to ensure the provision 
of safe patient care within VHA. The Acting Under Secretary for Health 
directed the uniform organizational alignment of SPD within VHA 
facilities. This organizational alignment defines responsibilities and 
expectations of leadership and implements a uniform reporting structure 
for SPD to assist in the implementation of quality controls and ensure 
compliance with directives.

    Question 4(b): What actions have you taken to improve each of the 
AIB concerns?

    Response: For the Miami VAMC, the following areas have been 
identified and addressed by the facility:

    Inventory Control: To ensure equipment inventory listing (EIL) 
accuracy, the director has detailed an administrative officer to 
execute the plan to correct the content of all EILs. The biomedical 
engineering (BME), acquisitions & materiel management (A&MM), and 
engineering services share access and control the automated engineering 
management system/medical equipment reporting (AEMS/MERS) file to 
ensure maintenance and repair activity, location of equipment removed 
for repair, as well as equipment excess and new acquisitions are 
properly recorded in real time. Vendor access to key procedure areas, 
particularly operating rooms (OR), is subject to restriction per 
policy. Prior to newly acquired equipment being released to a service, 
A&MM and BME collaborate to ensure device-specific SOPs exist in the 
using service and in SPD, as necessary.
    Oversight: Appointment of a program management official that 
reports to the facility director. This individual has oversight 
responsibilities for program areas including A&MM and BME services and 
cochairs the reusable medical equipment committee. Gastrointestinal 
(GI) technicians were moved organizationally from medical service to 
nursing service. An additional full-time employee equivalent (FTEE) 
clinical nurse specialist position was approved and is in the 
recruitment process. This position's sole purpose will be to provide 
oversight, training, and competence assessments for GI staff. 
Currently, the OR nurse educator fulfills this function. Quality 
assurance program with monitors, unannounced audits, and Joint 
Commission-type tracers are being instituted to facilitate outcome 
measurements.
    Supervision: The structure in place reflects lead technicians in 
reprocessing areas. The first line reprocessing area supervisor reports 
to the assistant chief, SPD. This position, in turn, reports to the 
chief, SPD. The chief, SPD, provides overall supervision to the 
reprocessing areas.
    Training: Providers, nursing staff, GI technicians, SPD technicians 
and supervisors have completed training provided by the endoscope 
manufacturer (Olympus), VACO SPD program office, and by VA SPD staff 
from Bay Pines, Florida. Four GI staff (nurses and technicians) spent 
on-site time training at the Richmond VAMC. All SPD technicians have 
completed the Level 1 40-hour training curriculum out of the SPD VACO 
program office. Three-fourths of the SPD technicians have taken the 
optional Level 2 exam, which completes the certification process. The 
remainder of SPD staff is in training to prepare for the certification 
exam. The chief, A&MM at Miami completed training at the logistics 
conference in June 2009. An extensive training module was established 
on all RME and is being mobilized throughout the organization to all 
employees. The Miami VA Healthcare System is developing a partnership 
with the Homestead Air Force Base to take SPD technicians on a tour and 
demonstration of the need for accuracy in the aviation industry, to 
conceptualize and link this model to the endoscopy reprocessing for 
patient safety.
    Communication: The communication process for patient safety alerts 
(PSA) was revised by the executive team in conjunction with the patient 
safety officer (PSO). The PSO is the official point of contact to 
disseminate all VISN action items/PSAs and is responsible for the 
overall coordination of responses to the alerts. Alerts require 
written, certified responses to the PSO that are aggregated and 
reviewed by the oversight executive prior to submission. Employee 
responsibility and response to PSAs are included in the training 
curriculum for the REM process.
    Competence Assessment: Competency affects the quality of direct 
patient care. The competence assessment process was revised to include 
return demonstrations on all equipment usage. Competence assessment 
reflects manufacturer instructions. Competency of those identified to 
assess competency of others is verified. Written SOPs on the setup, 
use, maintenance, pre-cleaning/cleaning and/or reprocessing developed 
and disseminated to all using employees are used as the basis for 
checklists (checks and balances), training, and competency.

    Question 5: How can the Patient Safety Alert system at every VISN 
and Medical Center be improved and what actions have been taken to 
further this end?

    Response: PSAs are issued by the DUSHOM through VHA's hazard alert 
electronic mail group. This mail group has approximately 1,500 field-
based members, including top management at each VISN and VHA medical 
facility. In addition, all patient safety officers and patient safety 
managers in VHA receive the alert. This distribution approach was 
adopted after evaluation of the obstacles to dissemination for PSAs in 
the past to provide a more robust, redundant, and reliable method for 
dissemination. PSAs transmit specific actions that must be implemented, 
identify the individual responsible for the action implementation (by 
title), and establish a due date by which the action must be completed. 
To provide further insight and accountability tools to management at 
all levels, the final action in each PSA requires the facility patient 
safety manager, on behalf of the facility director, to document on 
VHA's alert and recalls intranet Web site that the actions in the alert 
were implemented. This last step provides VHA the opportunity to 
periodically review facility compliance with alert action 
implementation. These processes were instituted, some fairly recently, 
as a result of a continual assessment of the PSA system. We will 
continue to evaluate and make changes as necessary to enable the PSAs 
to best achieve their desired objectives.

    Question 6: Please provide the Committee the results of the 2007 
and 2008 self-assessment survey, a list of all names of all VHA senior 
managers who were briefed on the results, and what remedial actions 
were recommended, as well as a timeline for implementation of these 
remedial actions to be completed.

    Response: The Committee was provided this information immediately 
after the hearing as a followup deliverable. An additional copy is 
included with these replies and labeled Attachment 1.

    Question 7: What metrics does the VA plan to utilize in order to 
measure the effectiveness of compliance with the International 
Organization for Standardization (ISO 9001), and when does VA plan to 
implement ISO 9001?

    Response: ISO 9001 is based on standardization of processes. VHA 
plans to implement ISO 9001 guidelines throughout VHA facilities by 
July 1, 2011. Metrics used to measure effectiveness of compliance 
include:

      Regular review of SOPs at each facility for uniformity 
throughout VHA facilities.
      Regular review of staff competency to perform assigned 
tasks through the use of standardized competency checklists which are 
uniform throughout VHA facilities.

    Question 8: Please provide a report back to the Committee on what 
endoscopes are currently being utilized at the various VA facilities, 
how many of these endoscopes can be equipped with disposable tubing, 
and if there would be any benefits in either cost savings or patient 
safety in moving toward the use of disposable tubing.

    Response: An integrated procurement team (IPT) that includes 
clinicians has been chartered by logistics [a combination of 
purchasing, supply chain management and in some cases contracting] to 
look at various aspects of flexible endoscopes, including lease vs. 
purchase options. A survey is being formulated to address the number 
and type of endoscopes in use in the field. Survey distribution to the 
field is anticipated to occur in August 2009. It is anticipated that 
the survey information will be returned by August 31, 2009. An analysis 
will be completed by September 30, 2009, with a report identifying the 
manufacturer, the type and number of endoscopes presently being used in 
VA. VA is committed to standardization of endoscope purchases at the 
facility level in support of effective training and process management; 
however, there will be flexibility related to specialty procedures and 
the preference of the clinician. At this time, the information gathered 
supports that most endoscopes should be able to use disposable tubing.
    When reviewing the cost benefit analysis of disposable tubing vs. 
reusable tubing and patient safety, it is cost effective to provide 
each patient with a known sterile item. The costs associated with 
reprocessing reusable tubing involve labor costs, facility utility 
costs, and the cost of cleaning supplies (detergents, brushes, 
enzymatic cleaners) which will usually exceed the cost of the 
disposable item.

    Question 9: Please detail the methodology VA is implementing to 
assure continued training and competencies of staff responsible for 
cleaning and sterilizing all medical equipment, including scopes and 
endoscopes.

    Response: VHA Directive 2009-031, issued June 26, 2009, established 
competency requirements for all staff responsible for reprocessing 
reusable medical equipment, as well as identified responsible persons 
for oversight of these competencies.
    The National Infectious Diseases (ID) Program Office provides a 
variety of annual education and training opportunities to staff at all 
SPD levels. Six cluster trainings are offered annually in various 
locations throughout the country, specific to staff responsible for 
reprocessing medical equipment. This training covers such topics as 
basic anatomy and physiology, medical terminology, basic microbiology 
and concepts of disease transmission, and SPD specific topics of 
disinfection, decontamination, sterilization, preparation, 
distribution, monitoring, and inventory management. Additionally, the 
SPD learning institute was established recently to host hands-on 
training for employees both within and outside of SPD who are 
responsible for reprocessing reusable medical equipment or other 
devices. In the coming fiscal year, the program office also looks 
forward to directing presentations specifically for staff that 
reprocess reusable medical equipment outside of SPD.
    Aside from these opportunities for staff directly involved in 
reprocessing reusable medical equipment, the ID Office also directs 
professional conferences for SPD chiefs, assistant chiefs, supervisors 
and managers who supervise SPD chiefs. These conferences provide an 
overview of the same SPD specific topics taught at the cluster training 
but also review other information relevant to SPD management, such as 
oversight of SPD activities, Occupational Safety and Health 
Administration (OSHA) standards, and prime vendor, etc. In addition to 
these annual professional conferences, in fiscal 2009 the office will 
host a conference entitled, Reprocessing of Reusable Medical Equipment: 
Using a Team Approach toward a Strategic Plan. The ID Office has begun 
to craft specific objectives for the target audience, which includes 
facility SPD chiefs, nurse executives (as the newly appointed managers 
of SPD) and the VISN SPD management boards.
    Last, the ID Office is actively involved in nontraditional training 
and education venues. The office has widely distributed multiple SPD 
operations DVDs and will distribute additional DVDs currently in 
production: Endoscopes Part II--Components, Accessories, and Special 
Considerations, Special Reprocessing Considerations--Powered Surgical 
Instruments, Microsurgical Instruments and Laparoscopes, and Non-
biological Implantable Devices. The ID Office is currently reviewing 
software solutions for ongoing review and management of applicable 
operating procedures, competencies and manufacturing instructions for 
reprocessing of reusable medical equipment. The ID Office further hosts 
monthly SPD conference calls where the latest directives, technical 
information, training opportunities, procedure changes, hot topics, 
manufacturer instructions and recommended practices are reviewed and 
discussed. The office participates in a variety of other conference 
calls for the purposes of information sharing nationally.

    Question 10: What coordination has been done between VA and the 
Department of Health and Human Services to share information regarding 
patient safety alerts on this issue, as well as other issues that have 
arisen in the treatment of veterans at the VA?

    Response: VHA patient safety alert developed by the National Center 
for Patient Safety (NCPS) in collaboration with VHA's ID Office, the 
Office of the DUSHOM, and the manufacturer in December 2008 has been 
posted on NCPS' Web site (www.patientsafety.gov). It is available for 
reference and use by other agencies and health care organizations. 
Based on discussions with NCPS staff, and data sharing, the Department 
of Defense's (DoD) Patient Safety Center is developing an endoscope 
reprocessing advisory. It builds in part on lessons learned from VHA; 
DoD shared its draft advisory with NCPS on July 2, 2009. Also in early 
July, VHA's Office of Quality and Performance, in collaboration with 
NCPS, contacted the Food and Drug Administration (FDA) and the Joint 
Commission on behalf to convene a joint meeting and begin discussions 
on a national public and private sector response. This would build upon 
the VHA/FDA meeting on June 4, which preceded the completion of VHA 
directive 2009-031. In addition, VHA's Office of Patient Care Services 
is working directly with FDA to expand their existing joint program on 
post-market device surveillance to include endoscopy issues.

                              Attachment A
                  Deliverables from Endoscopy Hearing
           HVAC Subcommittee on Oversight and Investigations
                             June 16, 2009
Questions:

      Results of 2007 and 2008 Self Assessment Surveys
      List of VA Management who were briefed on the results
      Remedial actions recommended and when implemented
      Subcommittee will ask IG to re-inspect VHA facilities for 
compliance within 90 days--Expect next report to be 100%

    1.  The actual spreadsheets that contain the questions the facility 
review teams used to conduct the National Supply, Processing and 
Distribution (SPD) Quality Management Observational Assessment for the 
four (4) different types of flexible endoscopes assessed.
    2.  National summary results for FY 07 and FY 08 for each of the 
four (4) different types of flexible endoscopes. The results correspond 
to the questions on the spreadsheets for each of the endoscopes.
    3.  Contained within each of the national summaries is information 
about how the observational assessments were conducted, reporting 
requirements, taking corrective action and what groups received 
presentations of the national summaries.

                               __________

   VHA National SPD Quality Management Observational Assessment Tool
                          Flexible Cystoscopes


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Station Number:                                                  November, 2007
-----------------------------------------------------------------------------------
Location of facility (city/state):
-----------------------------------------------------------------------------------
VISN #:
-----------------------------------------------------------------------------------
Name/Title of Contact Person:
-----------------------------------------------------------------------------------
Contact Person's Phone Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  This section of the observational assessment will entail a review of a flexible cystoscope. The facility
review team (the Patient Safety Manager, Infection Control Professional, Quality Management Representative and
Chief of SPD) will need to identify every area in the facility where a flexible cystoscope and its components
are reprocessed. This will require the review team to coordinate their schedules with staff in areas where a
flexible cystoscope is reprocessed. The review of flexible cystoscopes will be limited to the parent facility
and does not include a review of flexible cystoscopes reprocessed at remote locations, e.g., community based
outpatient clinics. The team is encouraged though to eventually review any reprocessing of flexible cystoscopes
at remote locations. The team must go to each area at the parent facility where a flexible cystoscope is
reprocessed and observe firsthand the flexible cystoscope actually being reprocessed after use. The team will
conduct only one observation per area where the flexible cystoscope is being reprocessed.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  The team must inform, in advance, any employee, of their intent to come and observe him/her reprocessing this
flexible cystoscope. The team must also explain why they are coming and what the observation will entail. The
team must interact with the employee(s) in a collegial and respectful manner. It is recommended that the team go
and look at a flexible cystoscope and become familiar with it before using this observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Again, the review team must observe staff, who are normally assigned to reprocess flexible cystoscopes, in
each area at the parent facility where one is reprocessed and separately report the findings for each area.
Flexible cystoscopes are typically reprocessed in SPD, the Operating Room or an outpatient area, etc. So, again,
the team must identify every area in the parent facility where a flexible cystoscope is reprocessed and fill in
the columns in the spreadsheet corresponding to each area (see below). The reason this is required is to observe
and assess if reprocessing is being performed correctly, consistently in each area throughout the facility.
----------------------------------------------------------------------------------------------------------------
  When observing the flexible cystoscope being reprocessed the team will ask the employee who is reprocessing
the flexible cystoscope to describe verbally what he/she is doing as he/she works and why he/she is doing it.
Through this observation and interaction the review team will be able to answer most of the questions in this
section of the observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  IMPORTANT: The team must not prompt the employee to complete any of the reprocessing steps covered in this
observational assessment tool. The review team's job is to observe whether the employee is actually completing
the reprocessing steps without being prompted. The review team must also actually observe firsthand the employee
performing the work and not ask the employee whether he/she does any of the steps and accept a yes answer.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  1. How many different areas within the parent
facility are there in which a flexible
cystoscope is reprocessed? ____ Answer with a
number to indicate how many different areas. If
the answer is zero, then this section is
completed. If the answer is one or more then
continue on.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Reminder: The team must complete this observational assessment tool for each area at the parent facility where
a flexible cystoscope is reprocessed. On the spreadsheet below, there are columns for the different locations
that will need to be filled in based on the answer to this question and question #3 below.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
   Place a ``Y'' or ``N'' in the appropriate
                     block.                       Yes   No
----------------------------------------------------------------------------------------------------------------
  2. Are flexible cystoscopes reprocessed at
remote locations outside of the parent
facility, e.g., community based outpatient
clinics? Yes or No Note: This will require the
review team to contact each location and ask if
flexible cystoscopes are reprocessed at it.
Again, the review team will NOT be required to
conduct observations at these remote locations
and report on them within this tool. The review
team is encouraged though to eventually review
any reprocessing at these remote locations.
------------------------------------------------------------------------------------------------------------------------
  3. Are flexible cystoscopes reprocessed at
the parent facility in:
------------------------------------------------------------
  a. SPD  Yes or No
------------------------------------------------------------
  b. The operating room      Yes or No
------------------------------------------------------------
  c. Outpatient area      Yes or No
------------------------------------------------------------
  d. Other _____      Yes or No
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
 Place a ``Y'' or ``N'' in the appropriate      SPD      Operating   Outpatient    Other      Other      Other
   block. Fill in the name of the ``Other   -----------    Room         Area      Location   Location   Location
 Location(s)'' in the appropriate column(s)            -------------------------    ____       ____       ____
    to the right, in which the flexible                                         --------------------------------
  cystoscope is reprocessed at the parent     Yes   No   Yes   No     Yes    No
                 facility.                                                        Yes   No   Yes   No   Yes   No
----------------------------------------------------------------------------------------------------------------
  4. Were the manufacturer's instructions
for reprocessing the flexible cystoscope
available for review? Yes or No Note: The
team should see the document and not ask
whether one exists and accept a yes answer.
----------------------------------------------------------------------------------------------------------------
  5. Was a local, written standard
operating procedure (SOP) for reprocessing
the flexible cystoscope available? Yes or
No Note: The team should see the document
and not ask whether one exists and accept a
yes answer.
----------------------------------------------------------------------------------------------------------------
  6. Did the SOP follow the manufacturer's
instructions for reprocessing the flexible
cystoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  7. Was the SOP approved by the facility's
Infection Control Committee? Yes or No
Note: The team should see an actual
document which indicates it was approved by
the Infection Control Committee.
----------------------------------------------------------------------------------------------------------------
  8. Are current training records available
for each employee who reprocesses this
flexible cystoscope? Yes or No Note: The
team will need to ask for names of
employees who reprocess this flexible
cystoscope and review training
documentation. To answer yes, all training
records must be present and current within
the past year.
----------------------------------------------------------------------------------------------------------------
  9. Was a wet leak test conducted on the
flexible cystoscope? Yes or No or Not
Applicable (NA). If NA, place an ``NA'' in
the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  10. Was the flexible cystoscope
disassembled so that all components were
separated for reprocessing? Yes or No or
Not Applicable (NA). If ``NA'', place an
``NA'' in the ``No'' block. Note: Some
flexible cystoscopes may or may not have
parts that require disassembly. Parts
include, e.g., water, suction and biopsy
ports/covers.
----------------------------------------------------------------------------------------------------------------
  11. Was an enzymatic detergent solution
prepared in accordance with the
manufacturer's instructions? Yes or No
Note: The team will need to review the
manufacturer's instructions for the
enzymatic detergent. The team should ensure
that the detergent being used is an
enzymatic detergent (an enzymatic detergent
removes proteins as well as other material)
and not merely a hospital grade detergent
(which does not remove proteins), and that
it is a combination of both. The team
should not only review how the enzymatic
detergent solution is prepared, but also
what the instructions are for how many
times it can be used before it has to be
changed and what the practice is at the
facility. See question 20 as well.
----------------------------------------------------------------------------------------------------------------
  12. Was the flexible cystoscope and all
its components, channels and lumens
completely immersed in an enzymatic
detergent to cover all external and
internal surfaces? Yes or No
----------------------------------------------------------------------------------------------------------------
  13. Was the flexible cystoscope and its
components, channels and lumens cleaned
with an enzymatic detergent, e.g., with a
sponge or brush using mechanical motions,
to ensure bioburden was removed?
Yes or No
----------------------------------------------------------------------------------------------------------------
  14. Was attention given to brushing
internal channels and lumens to ensure
bioburden was removed? Yes or No
----------------------------------------------------------------------------------------------------------------
  16. Were new brushes* used to clean each
flexible cystoscope? Yes or No. Note: The
team is looking to see if the same brushes
are used throughout the day to process
every flexible cystoscope and its parts or
whether new ones are used for each flexible
cystoscope processed.
----------------------------------------------------------------------------------------------------------------
  * New brushes are defined as new out of
the package or those that have been through
a sterilization process.
----------------------------------------------------------------------------------------------------------------
  17. Were all internal channels and lumens
flushed with an enzymatic detergent?
Yes or No
----------------------------------------------------------------------------------------------------------------
  18. After processing in the enzymatic
detergent, was the flexible cystoscope and
its components rinsed with water?
Yes or No
----------------------------------------------------------------------------------------------------------------
  19. After processing in the enzymatic
detergent was the flexible cystoscope's
internal channels and lumens flushed with
water? Yes or No
----------------------------------------------------------------------------------------------------------------
  20. If indicated in the manufacturer's
instructions, was the enzymatic detergent
changed after each flexible cystoscope was
cleaned? Yes or No or Not Applicable (NA)
Note: The team will need to refer to the
manufacturer's instructions for use. If
``NA'', place ``NA'' in the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  21. Is the sink that is used for the
cleaning processes above cleaned at least
on a daily basis? Yes or No Note: The team
will probably not be able to observe this
being done, but should ask who cleans the
sink and how often is it cleaned.
----------------------------------------------------------------------------------------------------------------
  22. Is the flexible cystoscope used in
conjunction with a sterile field, e.g.,
sterile gloves are used and there is a
sterile back table?
Yes or No
----------------------------------------------------------------------------------------------------------------
  After the decontamination/cleaning
process, how is the flexible cystoscope
reprocessed? Answer the following questions
below.
----------------------------------------------------------------------------------------------------------------
  23. Is it sterilized in an ethylene oxide
(EtO) sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  24. Is it sterilized in a steam
sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  25. Is it sterilized in a Sterrad
Sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  26. If it is sterilized in a Sterrad
Sterilizer, is there written validation
from the manufacturer   of the flexible
cystoscope   on file? Yes or No.      Note:
The team should review the actual written
validation.
----------------------------------------------------------------------------------------------------------------
  27. Is it sterilized in a Steris 1
System sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  28. Is it high-level disinfected? Yes or
No
----------------------------------------------------------------------------------------------------------------
  If the answer to question 28 above was
yes, the team needs to complete questions
29-40 below for high-level disinfectant.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 27 above was
yes, the team needs to complete questions
41-50 below for Steris 1 System
sterilizer.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 23 (EtO),
24 (Steam) or 25 (Sterrad Sterilizer)
above was yes, then this section is
complete.
----------------------------------------------------------------------------------------------------------------
          High Level Disinfectant
----------------------------------------------------------------------------------------------------------------
  29. If a high-level disinfectant is used,
was it checked before use in accordance
with the manufacturer's instructions with a
chemical strip to validate its strength to
effectively disinfect?
Yes or No
----------------------------------------------------------------------------------------------------------------
  30. After testing the high-level
disinfectant, was the result recorded and
signed by the person doing the testing? Yes
or No. Note: Both recording and signature
must be done to answer ``yes'' to this
question.
----------------------------------------------------------------------------------------------------------------
  31. If high-level disinfectant was used,
was it used in accordance with the
manufacturer's instructions? Yes or No.
Note: The team must review the
manufacturer's instructions of the high-
level disinfectant being used. The team is
checking to see what the exposure time is
and whether the scope and its components
were in the high-level disinfectant for the
time period required. The team should ask
how the individual reprocessing the scope
and its components knows that it was
exposed for the required time, e.g., is a
timer and log book used?
----------------------------------------------------------------------------------------------------------------
  32. If high-level disinfectant was used,
was the flexible cystoscope and its
components completely immersed in it to
cover all external and internal surfaces?
Yes or No
----------------------------------------------------------------------------------------------------------------
  33. If high-level disinfectant was used,
was attention given to flushing channels
and lumens? Yes or No
----------------------------------------------------------------------------------------------------------------
  34. If high-level disinfectant was used,
was the flexible cystoscope and all its
components rinsed thoroughly rinsed with
the appropriate type of water according to
the manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  35. If high-level disinfectant was used,
was attention given to flushing/rinsing the
internal channels and lumens of the
flexible cystoscope with the appropriate
type of water according to the
manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  36. If high-level disinfectant was used,
and after rinsing/flushing with the
appropriate type of water, was the flexible
cystoscope and its parts dried with a
sterile towel? Yes or No
----------------------------------------------------------------------------------------------------------------
  37. Was the flexible cystoscope rinsed
with alcohol, its channels flushed with it
and      then blown out with compressed air
before it was stored if it was not going to
be used within   2 hours? Yes or No.
Note: All must be done   to answer yes to
this question.
----------------------------------------------------------------------------------------------------------------
  38. Was the flexible cystoscope stored in
a clean, closed container or hung
vertically in a clean, closed cabinet
without the end of it touching the bottom
of the cabinet?
Yes or No
----------------------------------------------------------------------------------------------------------------
  39. Was a log maintained to reflect what
specific scopes were reprocessed in high-
level disinfectant? Yes or No. Note: The
log should include the serial number of
each scope reprocessed, the date it was
disinfected, and the name of the individual
doing the reprocessing. All must be present
to answer yes to this question.
----------------------------------------------------------------------------------------------------------------
  40. Is the SOP written clearly enough
that the team would be able to take the SOP
and use it to correctly reprocess the
flexible cystoscope?
Yes or No
----------------------------------------------------------------------------------------------------------------
        Steris 1 System Sterilizer
----------------------------------------------------------------------------------------------------------------
  41. Were all the connectors identified
for the specific scope used to reprocess
the flexible cystoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  42. Was the flexible cystoscope rinsed
with alcohol, its channels/lumens flushed
with it and then blown out with compressed
air before it was stored if it was not
going to be used within   2 hours? Yes or
No.      Note: All must be done   to answer
yes to this question.
----------------------------------------------------------------------------------------------------------------
  43. After reprocessing in the Steris 1
System sterilizers was the flexible
cystoscope stored in a clean, closed
container or hung vertically in a clean,
closed cabinet without the end of it
touching the bottom of the cabinet? Yes or
No
----------------------------------------------------------------------------------------------------------------
  Steris 1 System sterilizers have a
recording device that provides a printed
record that indicates the amount of time
the sterilizer ran and whether sterilant
concentration was met for each cycle. It
must be reviewed by an employee who is
responsible for reprocessing the flexible
cystoscope and have his/her signature
recorded on it to indicate that it has been
reviewed and meets parameters each time the
sterilizer is used.
----------------------------------------------------------------------------------------------------------------
  The review team must review records for
the past 1-month period for all questions
where indicated so as to have the most
current information.
----------------------------------------------------------------------------------------------------------------
  44. Does the Steris 1 System sterilizer
have a printout for each time it has been
used? Yes or No
----------------------------------------------------------------------------------------------------------------
  45. For each time the Steris 1 System
steri- lizerwasused,diditmeet time and
concentration parameters? Yes or No. Note:
The usual cycle time is 28 minutes, but
varies. The team will need to review the
manufacturer's instructions. The printout
will indicate whether the sterilant
concentration was met or not by having,
e.g., aborted, cycle aborted, on it.
Aborted or similar terms mean the cycle was
not completed and the items not sterilized.
The team will need to review the printout
and see what time was reached and recorded
on the printout and if the printout
indicated the cycle was aborted or not.
----------------------------------------------------------------------------------------------------------------
  46. If there were any instances that the
Steris 1 System sterilizer did not meet
parameters, was documentation available to
reflect that actions were taken to
determine the cause, correct it, and that
the flexible cystoscope was sent back for
another attempt to sterilize it? Yes or No.
Note: All must be present to answer ``yes''
to this question.
----------------------------------------------------------------------------------------------------------------
  47. Has each printout been reviewed by
the employee who is responsible for
reprocessing the flexible cystoscope, which
should be indicated on the printout by a
signature of the person doing the review?
Yes or No. Note: The printout is not to be
initialed, it must be signed. The signature
must be legible to identify the person who
reviewed it. The signature must be the
person's usual signature that they would
normally use. The review is to verify that
the parameters have been met.
----------------------------------------------------------------------------------------------------------------
  48. Does the printout include which
specific flexible cystoscope was
reprocessed in the Steris 1 System
sterilizer? Yes or No. Note: In the event a
biological indicator test comes back
positive, then one must be able to know
what specific flexible cystoscope was
processed in the sterilizer. The printout
must include the scope's serial number. The
serial number is important to have written
on the printout to allow one to be able to
recall the specific scope in the event of a
positive biological indicator and also link
what scope(s) was used on a given
patient(s).
----------------------------------------------------------------------------------------------------------------
  49. Dotherecordsshow that a biological
indicator test was performed at least daily
on days the Steris 1 System sterilizer was
anticipated to be used? Yes or No.   Note:
The biological indicator test must include
(1) a biological indicator processed
through the sterilizer with results
recorded and (2) a biological indicator
control that is not processed through the
sterilizer with the results recorded. The
results of the processed biological
indicator must be negative and the results
of the biological indicator control must be
positive. All elements must be present to
answer ``yes'' to this question.
----------------------------------------------------------------------------------------------------------------
  50. Does the facility have local, written
standard operating procedures in the event
of a positive biological indicator with the
Steris 1 System sterilizer? Yes or No.
Note: The team should review the document
and not ask whether one exists and accept a
yes answer.
----------------------------------------------------------------------------------------------------------------


                               __________

                                                            6/18/09
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                          FLEXIBLE CYSTOSCOPES
                          FY 2007 AND FY 2008
    On the following two pages are the national summary results for 
flexible cystoscopes from the observational assessments conducted in FY 
2007 and FY 2008. The results represent the percentage of yes or yes in 
compliance answers that correspond to each of the questions contained 
within the observational assessment (see attached spreadsheet). The 
national results are based on facility and VISN submitted reports on 
the actual observation of staff reprocessing a flexible cystoscope by a 
four person review team at the facility. The team consisted of a 
Patient Safety Manager, an Infection Control Professional, a Quality 
Management Representative and the Chief of SPD. Facility specific 
results were to be reported to facility management by the review team.
    Facility management reported the results to VISN management. VISN 
management reviewed the results and then submitted them to VA Central 
Office. Both facility and VISN management were to review the results 
and develop corrective action plans, if indicated.
    The national summary results of the observational assessments have 
been presented to the following groups by staff from the National 
Infectious Diseases Program: Under Secretary's Coordinating Committee 
on Quality and Safety (USCCQS), National Leadership Board (consisting 
of VISN Directors), VISN Chief Medical Officers, VISN Quality 
Management Officers, VISN Logistics Officers, VISN Patient Safety 
Officers, Facility Chiefs of Supply, Processing and Distribution (SPD) 
and Facility Infection Control Professionals.
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                          FLEXIBLE CYSTOSCOPES
                          FY 2007 AND FY 2008


------------------------------------------------------------------------
                                               FY 07           FY 08
             Question Number              Percentage Yes  Percentage Yes
------------------------------------------------------------------------
 1                                                 1-4 Locations   1-4 Locations
------------------------------------------------------------------------
 2                                                  14%             12%
------------------------------------------------------------------------
 3 SPD                                               55              60
------------------------------------------------------------------------
   OR                                                40              39
------------------------------------------------------------------------
   OP                                                34              34
------------------------------------------------------------------------
   OTHER                                             17              13
------------------------------------------------------------------------
 4                                                   82              92
------------------------------------------------------------------------
 5                                                   70              81
------------------------------------------------------------------------
 6                                                   58              81
------------------------------------------------------------------------
 7                                                   37              68
------------------------------------------------------------------------
 8                                                   54              74
------------------------------------------------------------------------
 9                                                   77              91
------------------------------------------------------------------------
10                                                   99              95
------------------------------------------------------------------------
11                                                   79              88
------------------------------------------------------------------------
12                                                   88              94
------------------------------------------------------------------------
13                                                   89              94
------------------------------------------------------------------------
14                                                   96              94
------------------------------------------------------------------------
15                                                   96              96
------------------------------------------------------------------------
16                                                   64              86
------------------------------------------------------------------------
17                                                   88              95
------------------------------------------------------------------------
18                                                   87              95
------------------------------------------------------------------------
19                                                   81              94
------------------------------------------------------------------------
20                                                   88              91
------------------------------------------------------------------------
21                                                   97              94
------------------------------------------------------------------------
22                                                   NA              75
                                                                 New 08
------------------------------------------------------------------------
23                                                   NA              38
                                                                 New 08
------------------------------------------------------------------------
24                                                   NA               1
                                                                 New 08
------------------------------------------------------------------------
25                                                   NA               7
                                                                 New 08
------------------------------------------------------------------------
26                                                   NA              19
                                                                 New 08
------------------------------------------------------------------------
27                                                   68              62
------------------------------------------------------------------------
28                                                   19              15
------------------------------------------------------------------------
29                                                   94              96
------------------------------------------------------------------------
30                                                   74              92
------------------------------------------------------------------------
31                                                   87              92
------------------------------------------------------------------------
32                                                   97              87
------------------------------------------------------------------------
33                                                   90              96
------------------------------------------------------------------------
34                                                   71              96
------------------------------------------------------------------------
35                                                   71              96
------------------------------------------------------------------------
36                                                   65              69
------------------------------------------------------------------------
37                                                   73              85
------------------------------------------------------------------------
38                                                   65              88
------------------------------------------------------------------------
39                                                   53             73
------------------------------------------------------------------------
40                                                   55             83
------------------------------------------------------------------------
41                                                   98              99
------------------------------------------------------------------------
42                                                   45              64
------------------------------------------------------------------------
43                                                   81              92
------------------------------------------------------------------------
44                                                   97             100
------------------------------------------------------------------------
45                                                   91              96
------------------------------------------------------------------------
46                                                   73              76
------------------------------------------------------------------------
47                                                   53              74
------------------------------------------------------------------------
48                                                   60              81
------------------------------------------------------------------------
49                                                   88              91
------------------------------------------------------------------------
50                                                   85              87
------------------------------------------------------------------------


                               __________


   VHA National SPD Quality Management Observational Assessment Tool
                         Flexible Colonoscopes


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Station Number:                                                  November, 2007
-----------------------------------------------------------------------------------
Location of facility (city/state):
-----------------------------------------------------------------------------------
VISN #:
-----------------------------------------------------------------------------------
Name/Title of Contact Person:
-----------------------------------------------------------------------------------
Contact Person's Phone Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  This section of the observational assessment will entail a review of a flexible colonoscope. The facility
review team (the Patient Safety Manager, Infection Control Professional, Quality Management Representative and
Chief of SPD) will need to identify every area in the facility where a flexible colonoscope and its components
are reprocessed. This will require the review team to coordinate their schedules with staff in areas where a
flexible colonoscope is reprocessed. The review of flexible colonoscopes will be limited to the parent facility
and does not include a review of flexible colonoscopes reprocessed at remote locations, e.g., community based
outpatient clinics. The team is encouraged though to eventually review any reprocessing of flexible colonoscopes
at remote locations. The team must go to each area at the parent facility where a flexible colonoscope is
reprocessed and observe firsthand the flexible colonoscope actually being reprocessed after use. The team will
conduct only one observation per area where the flexible colonoscope is being reprocessed.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  The team must inform, in advance, any employee, of their intent to come and observe him/her reprocessing this
flexible colonoscope. The team must also explain why they are coming and what the observation will entail. The
team must interact with the employee(s) in a collegial and respectful manner. It is recommended that the team go
and look at a flexible colonoscope and become familiar with it before using this observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Again, the review team must observe staff, who are normally assigned to reprocess flexible colonoscopes, in
each area at the parent facility where one is reprocessed and separately report the findings for each area.
Flexible colonoscopes are typically reprocessed in SPD, the Operating Room or an outpatient area, etc. So,
again, the team must identify every area in the parent facility where a flexible colonoscope is reprocessed and
fill in the columns in the spreadsheet corresponding to each area (see below). The reason this is required is to
observe and assess if reprocessing is being performed correctly, consistently in each area throughout the
facility.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  When observing the flexible colonoscope being reprocessed the team will ask the employee who is reprocessing
the flexible colonoscope to describe verbally what he/she is doing as he/she works and why he/she is doing it.
Through this observation and interaction the review team will be able to answer most of the questions in this
section of the observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  IMPORTANT: The team must not prompt the employee to complete any of the reprocessing steps covered in this
observational assessment tool. The review team's job is to observe whether the employee is actually completing
the reprocessing steps without being prompted. The review team must also actually observe firsthand the employee
performing the work and not ask the employee whether he/she does any of the steps and accept a yes answer.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  1. How many different areas within the parent
facilityarethereinwhich a flexible colonoscope
is reprocessed? ____ Answer with a number to
indicate how many different areas. If the
answer is zero, then this section is completed.
If the answer is one or more then continue on.
----------------------------------------------------------------------------------------------------------------
  Reminder: The team must complete this observational assessment tool for each area at the parent facility where
a flexible colonoscope is reprocessed. On the spreadsheet below, there are columns for the different locations
that will need to be filled in based on the answer to this question and question #3 below.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
   Place a ``Y'' or ``N'' in the appropriate
                     block.                       Yes   No
----------------------------------------------------------------------------------------------------------------
  2. Are flexible colonoscopes reprocessed at
remote locations outside of the parent
facility, e.g., community based outpatient
clinics? Yes or No Note: This will require the
review team to contact each location and ask if
flexible colonoscopes are reprocessed at it.
Again, the review team will NOT be required to
conduct observations at these remote locations
and report on them within this tool. The review
team is encouraged though to eventually review
any reprocessing at these remote locations.
------------------------------------------------------------------------------------------------------------------------
  3. Are flexible colonoscopes reprocessed at
the parent facility in:
------------------------------------------------------------
  a. SPD  Yes or No
------------------------------------------------------------
  b. The operating room      Yes or No
------------------------------------------------------------
  c. Outpatient area      Yes or No
------------------------------------------------------------
  d. Other _____      Yes or No
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
 Place a ``Y'' or ``N'' in the appropriate      SPD      Operating   Outpatient    Other      Other      Other
   block. Fill in the name of the ``Other   -----------    Room         Area      Location   Location   Location
 Location(s)'' in the appropriate column(s)            -------------------------    ____       ____       ____
    to the right, in which the flexible                                         --------------------------------
  colonoscope is reprocessed at the parent    Yes   No   Yes   No     Yes    No
                 facility.                                                        Yes   No   Yes   No   Yes   No
----------------------------------------------------------------------------------------------------------------
  4. Were the manufacturer's instructions
for reprocessing the flexible colonoscope
available for review? Yes or No      Note:
The team should see the document and not
ask whether one exists and accept a yes
answer.
----------------------------------------------------------------------------------------------------------------
  5. Was a local, written standard
operating procedure (SOP) for reprocessing
the flexible colono- scopeavailable?YesorNo
Note: The team should see the document and
not ask whether one exists and accept a yes
answer.
----------------------------------------------------------------------------------------------------------------
  6. Did the SOP follow the manufacturer's
instructions for reprocessing the flexible
colonoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  7. Was the SOP approved by the facility's
Infection Control Committee? Yes or No
Note: The team should see an actual
document which indicates it was approved by
the Infection Control Committee.
----------------------------------------------------------------------------------------------------------------
  8. Are current training records available
for each employee who reprocesses this
flexible colonoscope? Yes or No Note: The
team will need to ask for names of
employees who reprocess this flexible
colonoscope and review training
documentation. To answer yes all training
records must be present and current within
the past year.
----------------------------------------------------------------------------------------------------------------
  9. Was a wet leak test conducted on the
flexible colonoscope? Yes or No or Not
Applicable (NA). If NA, place an ``NA'' in
the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  10. Was the flexible colonoscope
disassembled so that all components were
separated for reprocessing? Yes or No or
Not Applicable (NA). If ``NA'', place an
``NA'' in the ``No'' block. Note: Some
flexible colonoscopes may or may not have
parts that require disassembly. Parts
include, e.g., water, suction and biopsy
ports/covers.
----------------------------------------------------------------------------------------------------------------
  11. Was an enzymatic detergent solution
prepared in accordance with the
manufacturer's instructions? Yes or No
Note: The team will need to review the
manufacturer's instructions for the
enzymatic detergent. The team should ensure
that the detergent being used is an
enzymatic detergent (an enzymatic detergent
removes proteins as well as other material)
and not merely a hospital grade detergent
(which does not remove proteins), and that
it is a combination of both. The team
should not only review how the enzymatic
detergent solution is prepared, but also
what the instructions are for how many
times it can be used before it has to be
changed and what the practice is at the
facility. See question 20 as well.
----------------------------------------------------------------------------------------------------------------
  12. Was the flexible colonoscope and all
its components, channels and lumens
completely immersed in an enzymatic
detergent to cover all external and
internal surfaces? Yes or No
----------------------------------------------------------------------------------------------------------------
  13. Was the flexible colonoscope and its
components, channels and lumens cleaned
with an enzymatic detergent, e.g., with a
sponge or brush using mechanical motions,
to ensure bioburden was removed?
Yes or No
----------------------------------------------------------------------------------------------------------------
  14. Was attention given to brushing
internal channels and lumens to ensure
bioburden was removed? Yes or No
----------------------------------------------------------------------------------------------------------------
  15. Were brushes, appropriately sized,
for the internal lumen/channel being
cleaned, being used? Yes or No
----------------------------------------------------------------------------------------------------------------
  16. Were new brushes* used to clean each
flexi- blecolonoscope?YesorNo Note: The
team is looking to see if the same brushes
are used throughout the day to process
every flexible colonoscope and its parts or
whether new ones are used for each flexible
colonoscope processed.
----------------------------------------------------------------------------------------------------------------
  * New brushes are defined as new out of
the package or those that have been through
a sterilization process.
----------------------------------------------------------------------------------------------------------------
  17. Were all internal channels and lumens
flushed with an enzymatic detergent?
Yes or No
----------------------------------------------------------------------------------------------------------------
  18. After processing in the enzymatic
detergent, was the flexible colonoscope and
its components rinsed with water?
Yes or No
----------------------------------------------------------------------------------------------------------------
  19. After processing in the enzymatic
detergent was the flexible colonoscope's
internal channels and lumens flushed with
water? Yes or No
----------------------------------------------------------------------------------------------------------------
  20. If indicated in the manufacturer's
instructions, was the enzymatic detergent
changed after each flexible colonoscope was
cleaned? Yes or No or Not Applicable (NA)
Note: The team will need to refer to the
manufacturer's instructions for use. If
``NA'', place ``NA'' in the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  21. Is the sink that is used for the
cleaning processes above cleaned at least
on a daily basis? Yes or No Note: The team
will probably not be able to observe this
being done, but should ask who cleans the
sink and how often is it cleaned.
----------------------------------------------------------------------------------------------------------------
  After the decontamination/cleaning
process, how is the flexible colonoscope
reprocessed? Answer the following questions
below.
----------------------------------------------------------------------------------------------------------------
  22. Is it sterilized in an ethylene oxide
(EtO) sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  23. Is it sterilized in a steam
sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  24. Is it sterilized in a Sterrad
Sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  25. If it is sterilized in a Sterrad
Sterilizer, is there written validation
from the manufacturer   of the flexible
colonoscope   on file? Yes or No      Note:
The team should review the actual written
validation.
----------------------------------------------------------------------------------------------------------------
  26. Is it sterilized in a Steris 1
System sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  27. Is it high-level disinfected? Yes or
No
----------------------------------------------------------------------------------------------------------------
  If the answer to question 27 above was
yes, the team needs to complete questions
28-39 below for high-level disinfectant.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 26 above was
yes, the team needs to complete questions
40-49 below for Steris 1 System
sterilizer.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 22 (EtO),
23 (Steam) or 24 (Sterrad Sterilizer)
above was yes, then this section is
complete.
----------------------------------------------------------------------------------------------------------------
          High Level Disinfectant
----------------------------------------------------------------------------------------------------------------
  28. If a high-level disinfectant is used,
was it checked before use in accordance
with the manufacturer's instructions with a
chemical strip to validate its strength to
effectively disinfect?
Yes or No
----------------------------------------------------------------------------------------------------------------
  29. After testing the high-level
disinfectant, was the result recorded and
signed by the person doing the testing? Yes
or No Note: Both recording and signature
must be done to answer ``yes'' to this
question.
----------------------------------------------------------------------------------------------------------------
  30. If high-level disinfectant was used,
was it used in accordance with the
manufacturer's instructions? Yes or No
Note: The team must review the
manufacturer's instructions of the high-
level disinfectant being used. The team is
checking to see what the exposure time is
and whether the scope and its components
were in the high-level disinfectant for the
time period required. The team should ask
how the individual reprocessing the scope
and its components knows that it was
exposed for the required time, e.g., is a
timer and log book used?
----------------------------------------------------------------------------------------------------------------
  31. If high-level disinfectant was used,
was the flexible colonoscope and its
components completely immersed in it to
cover all external and in-
ternalsurfaces?YesorNo
----------------------------------------------------------------------------------------------------------------
  32. If high-level disinfectant was used,
was attention given to flushing channels
and lumens? Yes or No
----------------------------------------------------------------------------------------------------------------
  33. If high-level disinfectant was used,
was the flexible colonoscope and all its
components rinsed thoroughly rinsed with
the appropriate type of water according to
the manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  34. If high-level disinfectant was used,
was attention given to flushing/rinsing the
internal channels and lumens of the
flexible colonoscope with the appropriate
type of water according to the
manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  35. If high-level disinfectant was used,
and after rinsing/flushing with the
appropriate type of water, was the flexible
colonoscope and its parts dried with a
sterile towel? Yes or No
----------------------------------------------------------------------------------------------------------------
  36. Was the flexible colonoscope rinsed
with alcohol, its channels flushed with it
and      then blown out with compressed air
before it was stored if it was not going to
be used within   2 hours? Yes or No
Note: All must be done   to answer yes to
this question.
----------------------------------------------------------------------------------------------------------------
  37. Was the flexible colonoscope stored
in a clean, closed container or hung
vertically in a clean, closed cabinet
without the end of it touching the bottom
of the cabinet?
Yes or No
----------------------------------------------------------------------------------------------------------------
  38. Was a log maintained to reflect what
specific scopes were reprocessed in high-
level disinfectant? Yes or No Note: The log
should include the serial number of each
scope reprocessed, the date it was
disinfected, and the name of the individual
doing the reprocessing. All must be present
to answer yes to this question.
----------------------------------------------------------------------------------------------------------------
  39. Is the SOP written clearly enough
that the team would be able to take the SOP
and use it to correctly reprocess the
flexible colonoscope?
Yes or No
----------------------------------------------------------------------------------------------------------------
        Steris 1 System Sterilizer
----------------------------------------------------------------------------------------------------------------
  40. Were all the connectors identified
for the specific scope used to reprocess
the flexible colonoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  41. Was the flexible colonoscope rinsed
with alcohol, its channels/lumens flushed
with it and then blown out with compressed
air before it was stored if it was not
going to be used within   2 hours? Yes or
No      Note: All must be done   to answer
yes to this question.
----------------------------------------------------------------------------------------------------------------
  42. After reprocessing in the Steris 1
System sterilizers was the flexible
colonoscope stored in a clean, closed
container or hung vertically in a clean,
closed cabinet without the end of it
touching the bottom of the cabinet? Yes or
No
----------------------------------------------------------------------------------------------------------------
  Steris 1 System sterilizers have a
recording device that provides a printed
record that indicates the amount of time
the sterilizer ran and whether sterilant
concentration was met for each cycle. It
must be reviewed by an employee who is
responsible for reprocessing the flexible
colonoscope and have his/her signature
recorded on it to indicate that it has been
reviewed and meets parameters each time the
sterilizer is used.
----------------------------------------------------------------------------------------------------------------
  43. Does the Steris 1 System sterilizer
have a printout for each time it has been
used? Yes or No
----------------------------------------------------------------------------------------------------------------
  44. For each time the Steris 1 System
steri- lizerwasused,diditmeet time and
concentration parameters? Yes or No Note:
The usual cycle time is 28 minutes, but
varies. The team will need to review the
manufacturer's instructions. The printout
will indicate whether the sterilant
concentration was met or not by having,
e.g., aborted, cycle aborted, on it.
Aborted or similar terms mean the cycle was
not completed and the items not sterilized.
The team will need to review the printout
and see what time was reached and recorded
on the printout and if the printout
indicated the cycle was aborted or not.
----------------------------------------------------------------------------------------------------------------
  45. If there were any instances that the
Steris 1 System sterilizer did not meet
parameters, was documentation available to
reflect that actions were taken to
determine the cause, correct it, and that
the flexible colonoscope was sent back for
another attempt to sterilize it? Yes or No
Note: All must be present to answer ``yes''
to this question.
----------------------------------------------------------------------------------------------------------------
  46. Has each printout been reviewed by
the employee who is responsible for
reprocessing the flexible colonoscope,
which should be indicated on the printout
by a signature of the person doing the
review? Yes or No Note: The printout is not
to be initialed, it must be signed. The
signature must be legible to identify the
person who reviewed it. The signature must
be the person's usual signature that they
would normally use. The review is to verify
that the parameters have been met.
----------------------------------------------------------------------------------------------------------------
  47. Does the printout include which
specific flexible colonoscope was
reprocessed in the Steris 1 System
sterilizer? Yes or No Note: In the event a
biological indicator test comes back
positive, then one must be able to know
what specific flexible colonoscope was
processed in the sterilizer. The printout
must include the scope's serial number. The
serial number is important to have written
on the printout to allow one to be able to
recall the specific scope in the event of a
positive biological indicator and also link
what scope(s) was used on a given
patient(s).
----------------------------------------------------------------------------------------------------------------
  48. Dotherecordsshow that a biological
indicator test was performed at least daily
on days the Steris 1 System sterilizer was
anticipated to be used? Yes or No   Note:
The biological indicator test must include
(1) a biological indicator processed
through the sterilizer with results
recorded and (2) a biological indicator
control that is not processed through the
sterilizer with the results recorded. The
results of the processed biological
indicator must be negative and the results
of the biological indicator control must be
positive. All elements must be present to
answer ``yes'' to this question.
----------------------------------------------------------------------------------------------------------------
  49. Does the facility have local, written
standard operating procedures in the event
of a positive biological indicator with the
Steris 1 System sterilizer? Yes or No
Note: The team should review the document
and not ask whether one exists and accept a
yes answer.
----------------------------------------------------------------------------------------------------------------


                               __________

                                                            6/18/09
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                         FLEXIBLE COLONOSCOPES
                          FY 2007 AND FY 2008
    On the following two pages are the national summary results for 
flexible colonoscopes from the observational assessments conducted in 
FY 2007 and FY 2008. The results represent the percentage of yes or yes 
in compliance answers that correspond to each of the questions 
contained within the observational assessment (see attached 
spreadsheet). The national results are based on facility and VISN 
submitted reports on the actual observation of staff reprocessing a 
flexible colonoscope by a four person review team at the facility. The 
team consisted of a Patient Safety Manager, an Infection Control 
Professional, a Quality Management Representative and the Chief of SPD. 
Facility specific results were to be reported to facility management by 
the review team.
    Facility management reported the results to VISN management. VISN 
management reviewed the results and then submitted them to VA Central 
Office. Both facility and VISN management were to review the results 
and develop corrective action plans, if indicated.
    The national summary results of the observational assessments have 
been presented to the following groups by staff from the National 
Infectious Diseases Program: Under Secretary's Coordinating Committee 
on Quality and Safety (USCCQS), National Leadership Board (consisting 
of VISN Directors), VISN Chief Medical Officers, VISN Quality 
Management Officers, VISN Logistics Officers, VISN Patient Safety 
Officers, Facility Chiefs of Supply, Processing and Distribution (SPD) 
and Facility Infection Control Professionals.
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                         FLEXIBLE COLONOSCOPES
                          FY 2007 AND FY 2008


------------------------------------------------------------------------
                                               FY 07           FY 08
             Question Number              Percentage Yes  Percentage Yes
------------------------------------------------------------------------
 1                                                 1-4 Locations   1-4 Locations
------------------------------------------------------------------------
 2                                                  12%             14%
------------------------------------------------------------------------
 3 SPD                                               23              29
------------------------------------------------------------------------
   OR                                                31              27
------------------------------------------------------------------------
   OP                                                42              47
------------------------------------------------------------------------
   OTHER                                             37              32
------------------------------------------------------------------------
 4                                                   93              98
------------------------------------------------------------------------
 5                                                   75              85
------------------------------------------------------------------------
 6                                                   68              83
------------------------------------------------------------------------
 7                                                   40              70
------------------------------------------------------------------------
 8                                                   64              84
------------------------------------------------------------------------
 9                                                   93              97
------------------------------------------------------------------------
10                                                  100              99
------------------------------------------------------------------------
11                                                   79              92
------------------------------------------------------------------------
12                                                   90              97
------------------------------------------------------------------------
13                                                   93              99
------------------------------------------------------------------------
14                                                   99              99
------------------------------------------------------------------------
15                                                   99              99
------------------------------------------------------------------------
16                                                   72              90
------------------------------------------------------------------------
17                                                   95              99
------------------------------------------------------------------------
18                                                   86              85
------------------------------------------------------------------------
19                                                   83              96
------------------------------------------------------------------------
20                                                   89              96
------------------------------------------------------------------------
21                                                   97              97
------------------------------------------------------------------------
22                                                   NA               8
                                                                 New 08
------------------------------------------------------------------------
23                                                   NA               1
                                                                 New 08
------------------------------------------------------------------------
24                                                   NA               1
                                                                 New 08
------------------------------------------------------------------------
25                                                   NA               2
                                                                 New 08
------------------------------------------------------------------------
26                                                   66              59
------------------------------------------------------------------------
27                                                   68              43
------------------------------------------------------------------------
28                                                   89              94
------------------------------------------------------------------------
29                                                   71              92
------------------------------------------------------------------------
30                                                   89              94
------------------------------------------------------------------------
31                                                   97              99
------------------------------------------------------------------------
32                                                   95             100
------------------------------------------------------------------------
33                                                   47             100
------------------------------------------------------------------------
34                                                   39              99
------------------------------------------------------------------------
35                                                   71              63
------------------------------------------------------------------------
36                                                   82              87
------------------------------------------------------------------------
37                                                   78              86
------------------------------------------------------------------------
38                                                   70              90
------------------------------------------------------------------------
39                                                   67              80
------------------------------------------------------------------------
40                                                   99             100
------------------------------------------------------------------------
41                                                   56              83
------------------------------------------------------------------------
42                                                   86              86
------------------------------------------------------------------------
43                                                   97             100
------------------------------------------------------------------------
44                                                   93              94
------------------------------------------------------------------------
45                                                   80              79
------------------------------------------------------------------------
46                                                   63              72
------------------------------------------------------------------------
47                                                   65              87
------------------------------------------------------------------------
48                                                   89              87
------------------------------------------------------------------------
49                                                   87              88
------------------------------------------------------------------------


                               __________


   VHA National SPD Quality Management Observational Assessment Tool
              Flexible Esophagogastroduodenoscope (EGD's)


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Station Number:                                                  November, 2007
-----------------------------------------------------------------------------------
Location of facility (city/state):
-----------------------------------------------------------------------------------
VISN #:
-----------------------------------------------------------------------------------
Name/Title of Contact Person:
-----------------------------------------------------------------------------------
Contact Person's Phone Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  This section of the observational assessment will entail a review of a flexible esophagogastroduodenoscope
(EGD). The facility review team (the Patient Safety Manager, Infection Control Professional, Quality Management
Representative and Chief of SPD) will need to identify every area in the facility where a flexible EGD and its
components are reprocessed. This will require the review team to coordinate their schedules with staff in areas
where a flexible EGD is reprocessed. The review of flexible EGDs will be limited to the parent facility and does
not include a review of flexible EGDs reprocessed at remote locations, e.g., community based outpatient clinics.
The team is encouraged though to eventually review any reprocessing of flexible EGDs at remote locations. The
team must go to each area at the parent facility where a flexible EGD is reprocessed and observe firsthand the
flexible EGD actually being reprocessed after use. The team will conduct only one observation per area where the
flexible EGD is being reprocessed.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  The team must inform, in advance, any employee, of their intent to come and observe him/her reprocessing this
flexible EGD. The team must also explain why they are coming and what the observation will entail. The team must
interact with the employee(s) in a collegial and respectful manner. It is recommended that the team go and look
at a flexible EGD and become familiar with it before using this observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Again, the review team must observe staff, who are normally assigned to reprocess flexible EGDs, in each area
at the parent facility where one is reprocessed and separately report the findings for each area. Flexible EGDs
are typically reprocessed in SPD, the Operating Room or an outpatient area, etc. So, again, the team must
identify every area in the parent facility where a flexible EGD is reprocessed and fill in the columns in the
spreadsheet corresponding to each area (see below). The reason this is required is to observe and assess if
reprocessing is being performed correctly, consistently in each area throughout the facility.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  When observing the flexible EGD being reprocessed the team will ask the employee who is reprocessing the
flexible EGD to describe verbally what he/she is doing as he/she works and why he/she is doing it. Through this
observation and interaction the review team will be able to answer most of the questions in this section of the
observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  IMPORTANT: The team must not prompt the employee to complete any of the reprocessing steps covered in this
observational assessment tool. The review team's job is to observe whether the employee is actually completing
the reprocessing steps without being prompted. The review team must also actually observe firsthand the employee
performing the work and not ask the employee whether he/she does any of the steps and accept a yes answer.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  1. How many different areas within the parent
facilityarethereinwhich a flexible EGD is
reprocessed? ____ Answer with a number to
indicate how many different areas. If the
answer is zero, then this section is completed.
If the answer is one or more then continue on.
----------------------------------------------------------------------------------------------------------------
  Reminder: The team must complete this observational assessment tool for each area at the parent facility where
a flexible EGD is reprocessed. On the spreadsheet below, there are columns for the different locations that will
need to be filled in based on the answer to this question and question #3 below.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
   Place a ``Y'' or ``N'' in the appropriate
                     block.                       Yes   No
----------------------------------------------------------------------------------------------------------------
  2. Are flexible EGDs reprocessed at remote
locations outside of the parent facility, e.g.,
community based outpatient clinics? Yes or No
Note: This will require the review team to
contact each location and ask if flexible EGDs
are reprocessed at it. Again, the review team
will NOT be required to conduct observations at
these remote locations and report on them
within this tool. The review team is encouraged
though to eventually review any reprocessing at
these remote locations.
------------------------------------------------------------------------------------------------------------------------
  3. Are flexible EGDs reprocessed at the
parent facility in:
------------------------------------------------------------
  a. SPD  Yes or No
------------------------------------------------------------
  b. The operating room      Yes or No
------------------------------------------------------------
  c. Outpatient area      Yes or No
------------------------------------------------------------
  d. Other _____      Yes or No
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
 Place a ``Y'' or ``N'' in the appropriate      SPD      Operating   Outpatient    Other      Other      Other
   block. Fill in the name of the ``Other   -----------    Room         Area      Location   Location   Location
 Location(s)'' in the appropriate column(s)            -------------------------    ____       ____       ____
 to the right, in which the flexible EGD is   Yes   No                          --------------------------------
    reprocessed at the parent facility.                  Yes   No     Yes    No   Yes   No   Yes   No   Yes   No
----------------------------------------------------------------------------------------------------------------
  4. Were the manufacturer's instructions
for reprocessing the flexible EGD available
for review? Yes or No      Note: The team
should see the document and not ask whether
one exists and accept a yes answer.
----------------------------------------------------------------------------------------------------------------
  5. Was a local, written standard
operating procedure (SOP) for reprocessing
the flexible EGD available? Yes or No Note:
The team should see the document and not
ask whether one exists and accept a yes
answer.
----------------------------------------------------------------------------------------------------------------
  6. Did the SOP follow the manufacturer's
instructions for reprocessing the flexible
EGD?   Yes or No
----------------------------------------------------------------------------------------------------------------
  7. Was the SOP approved by the facility's
Infection Control Committee? Yes or No
Note: The team should see an actual
document which indicates it was approved by
the Infection Control Committee.
----------------------------------------------------------------------------------------------------------------
  8. Are current training records available
for each employee who reprocesses this
flexible EGD?         Yes or No Note: The
team will need to ask for names of
employees who reprocess this flexible EGD
and review training documentation. To
answer yes all training records must be
present and current within the past year.
----------------------------------------------------------------------------------------------------------------
  9. Was a wet leak test conducted on the
flexible EGD? Yes or No or Not Applicable
(NA). If ``NA'', place an ``NA'' in the
``No'' block.
----------------------------------------------------------------------------------------------------------------
  10. Was the flexible EGD disassembled so
that all components were separated for
reprocessing? Yes or No or Not Applicable
(NA). If ``NA'', place an ``NA'' in the
``No'' block. Note: Some flexible EGDs may
or may not have parts that require
disassembly. Parts include, e.g., water,
suction and biopsy ports/covers.
----------------------------------------------------------------------------------------------------------------
  11. Was an enzymatic detergent solution
prepared in accordance with the
manufacturer's instructions? Yes or No
Note: The team will need to review the
manufacturer's instructions for the
enzymatic detergent. The team should ensure
that the detergent being used is an
enzymatic detergent (an enzymatic detergent
removes proteins as well as other material)
and not merely a hospital grade detergent
(which does not remove proteins), and that
it is a combination of both. The team
should not only review how the enzymatic
detergent solution is prepared, but also
what the instructions are for how many
times it can be used before it has to be
changed and what the practice is at the
facility. See question 20 as well.
----------------------------------------------------------------------------------------------------------------
  12. Was the flexible EGD and all its
components, channels and lumens completely
immersed in an enzymatic detergent to cover
all external and internal surfaces? Yes or
No
----------------------------------------------------------------------------------------------------------------
  13. Was the flexible EGD and its
components, channels and lumens cleaned
with an enzymatic detergent, e.g., with a
sponge or brush using mechanical motions,
to ensure bioburden was removed?
Yes or No
----------------------------------------------------------------------------------------------------------------
  14. Was attention given to brushing
internal channels and lumens to ensure
bioburden was removed? Yes or No
----------------------------------------------------------------------------------------------------------------
  15. Were brushes, appropriately sized,
for the internal lumen/channel being
cleaned, being used? Yes or No
----------------------------------------------------------------------------------------------------------------
  16. Were new brushes* used to clean each
flexible EGD? Yes or No Note: The team is
looking to see if the same brushes are used
throughout the day to process every
flexible EGD and its parts or whether new
ones are used for each flexible EGD
processed.
----------------------------------------------------------------------------------------------------------------
  * New brushes are defined as new out of
the package or those that have been through
a sterilization process.
----------------------------------------------------------------------------------------------------------------
  17. Were all internal channels and lumens
flushed with an enzymatic detergent?
Yes or No
----------------------------------------------------------------------------------------------------------------
  18. After processing in the enzymatic
detergent, was the flexible EGD   and its
components rinsed with water?
Yes or No
----------------------------------------------------------------------------------------------------------------
  19. After processing in the enzymatic
detergent was the flexible EGD's internal
channels and lumens flushed with water? Yes
or No
----------------------------------------------------------------------------------------------------------------
  20. If indicated in the manufacturer's
instructions, was the enzymatic detergent
changed after each flexible EGD was
cleaned? Yes or No or   Not Applicable (NA)
Note: The team will need to refer to the
manufacturer's instructions for use. If
``NA'', place ``NA'' in the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  21. Is the sink that is used for the
cleaning processes above cleaned at least
on a daily basis? Yes or No Note: The team
will probably not be able to observe this
being done, but should ask who cleans the
sink and how often is it cleaned.
----------------------------------------------------------------------------------------------------------------
  After the decontamination/cleaning
process, how is the flexible EGD
reprocessed? Answer the following questions
below.
----------------------------------------------------------------------------------------------------------------
  22. Is it sterilized in an ethylene oxide
(EtO) sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  23. Is it sterilized in a steam
sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  24. Is it sterilized in a Sterrad
Sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  25. If it is sterilized in a Sterrad
Sterilizer, is there written validation
from the manufacturer   of the flexible EGD
on file? Yes or No Note: The team should
review the actual written validation.
----------------------------------------------------------------------------------------------------------------
  26. Is it sterilized in a Steris 1
System sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  27. Is it high-level disinfected? Yes or
No
----------------------------------------------------------------------------------------------------------------
  If the answer to question 27 above was
yes, the team needs to complete questions
28-39 below for high-level disinfectant.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 26 above was
yes, the team needs to complete questions
40-49 below for Steris 1 System
sterilizer.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 22 (EtO),
23 (Steam) or 24 (Sterrad Sterilizer)
above was yes, then this section is
complete.
----------------------------------------------------------------------------------------------------------------
          High Level Disinfectant
----------------------------------------------------------------------------------------------------------------
  28. If a high-level disinfectant is used,
was it checked before use in accordance
with the manufacturer's instructions with a
chemical strip to validate its strength to
effectively disinfect?
Yes or No
----------------------------------------------------------------------------------------------------------------
  29. After testing the high-level
disinfectant, was the result recorded and
signed by the person doing the testing? Yes
or No Note: Both recording and signature
must be done to answer ``yes'' to this
question.
----------------------------------------------------------------------------------------------------------------
  30. If high-level disinfectant was used,
was it used in accordance with the
manufacturer's instructions? Yes or No
Note: The team must review the
manufacturer's instructions of the high-
level disinfectant being used. The team is
checking to see what the exposure time is
and whether the scope and its components
were in the high-level disinfectant for the
time period required. The team should ask
how the individual reprocessing the scope
and its components knows that it was
exposed for the required time, e.g., is a
timer and log book used?
----------------------------------------------------------------------------------------------------------------
  31. If high-level disinfectant was used,
was the flexible EGD and its components
completely immersed in it to cover all
external and internal surfaces? Yes or No
----------------------------------------------------------------------------------------------------------------
  32. If high-level disinfectant was used,
was attention given to flushing channels
and lumens? Yes or No
----------------------------------------------------------------------------------------------------------------
  33. If high-level disinfectant was used,
was the flexible EGD and all its components
rinsed thoroughly rinsed with the
appropriate type of water according to the
manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  34. If high-level disinfectant was used,
was attention given to flushing/rinsing the
internal channels and lumens of the
flexible EGD with the appropriate type of
water according to the manufacturer's
instructions?      Yes or No
----------------------------------------------------------------------------------------------------------------
  35. If high-level disinfectant was used,
and after rinsing/flushing with the
appropriate type of water, was the flexible
EGD and its parts dried with a sterile
towel?      Yes or No
----------------------------------------------------------------------------------------------------------------
  36. Was the flexible EGD rinsed with
alcohol, its channels flushed with it and
then blown out with compressed air before
it was stored if it was not going to be
used within2hours?YesorNo Note: All must be
done   to answer yes to this question.
----------------------------------------------------------------------------------------------------------------
  37. Was the flexible EGD stored in a
clean, closed container or hung vertically
in a clean, closed cabinet without the end
of it touching the bottom of the cabinet?
Yes or No
----------------------------------------------------------------------------------------------------------------
  38. Was a log maintained to reflect what
specific scopes were reprocessed in high-
level disinfectant? Yes or No Note: The log
should include the serial number of each
scope reprocessed, the date it was
disinfected, and the name of the individual
doing the reprocessing. All must be present
to answer yes to this question.
----------------------------------------------------------------------------------------------------------------
  39. Is the SOP written clearly enough
that the team would be able to take the SOP
and use it to correctly reprocess   the
flexible EGD?
Yes or No
----------------------------------------------------------------------------------------------------------------
        Steris 1 System Sterilizer
----------------------------------------------------------------------------------------------------------------
  40. Were all the connectors identified
for the specific scope used to reprocess
the flexible EGD? Yes or No
----------------------------------------------------------------------------------------------------------------
  41. Was the flexible EGD rinsed with
alcohol, its channels/lumens flushed with
it and then blown out with compressed air
before it         was stored if it was not
going to be used within   2 hours? Yes or
No      Note: All must be done   to answer
yes to this question.
----------------------------------------------------------------------------------------------------------------
  42. After reprocessing in the Steris 1
System sterilizers was the flexible EGD
stored in a clean, closed container or hung
vertically in a clean, closed cabinet
without the end of it touching the bottom
of the cabinet? Yes or No
----------------------------------------------------------------------------------------------------------------
  Steris 1 System sterilizers have a
recording device that provides a printed
record that indicates the amount of time
the sterilizer ran and whether sterilant
concentration was met for each cycle. It
must be reviewed by an employee who is
responsible for reprocessing the flexible
EGD and have his/her signature recorded on
it to indicate that it has been reviewed
and meets parameters each time the
sterilizer is used.
----------------------------------------------------------------------------------------------------------------
  The review team must review records for
the past 1-month period for all questions
where indicated so as to have the most
current information.
----------------------------------------------------------------------------------------------------------------
  43. Does the Steris 1 System sterilizer
have a printout for each time it has been
used? Yes or No
----------------------------------------------------------------------------------------------------------------
  44. For each time the Steris 1 System
steri- lizerwasused,diditmeet time and
concentration parameters? Yes or No Note:
The usual cycle time is 28 minutes, but
varies. The team will need to review the
manufacturer's instructions. The printout
will indicate whether the sterilant
concentration was met or not by having,
e.g., aborted, cycle aborted, on it.
Aborted or similar terms mean the cycle was
not completed and the items not sterilized.
The team will need to review the printout
and see what time was reached and recorded
on the printout and if the printout
indicated the cycle was aborted or not.
----------------------------------------------------------------------------------------------------------------
  45. If there were any instances that the
Steris 1 System sterilizer did not meet
parameters, was documentation available to
reflect that actions were taken to
determine the cause, correct it, and that
the flexible EGD was sent back for another
attempt to sterilize it? Yes or No Note:
All must be present to answer ``yes'' to
this question.
----------------------------------------------------------------------------------------------------------------
  46. Has each printout been reviewed by
the employee who is responsible for
reprocessing the flexible EGD, which should
be indicated on the printout by a signature
of the person doing the review? Yes or No
Note: The printout is not to be initialed,
it must be signed. The signature must be
legible to identify the person who reviewed
it. The signature must be the person's
usual signature that they would normally
use. The review is to verify that the
parameters have been met.
----------------------------------------------------------------------------------------------------------------
  47. Does the printout include which
specific flexible EGD was reprocessed in
the Steris 1 System sterilizer? Yes or No
Note: In the event a biological indicator
test comes back positive, then one must be
able to know what specific flexible EGD was
processed in the sterilizer. The printout
must include the scope's serial number. The
serial number is important to have written
on the printout to allow one to be able to
recall the specific scope in the event of a
positive biological indicator and also link
what scope(s) was used on a given
patient(s).
----------------------------------------------------------------------------------------------------------------
  48. Dotherecordsshow that a biological
indicator test was performed at least daily
on days the Steris 1 System sterilizer was
anticipated to be used? Yes or No   Note:
The biological indicator test must include
(1) a biological indicator processed
through the sterilizer with results
recorded and (2) a biological indicator
control that is not processed through the
sterilizer with the results recorded. The
results of the processed biological
indicator must be negative and the results
of the biological indicator control must be
positive. All elements must be present to
answer ``yes'' to this question.
----------------------------------------------------------------------------------------------------------------
  49. Does the facility have local, written
standard operating procedures in the event
of a positive biological indicator with the
Steris 1 System sterilizer? Yes or No
Note: The team should review the document
and not ask whether one exists and accept a
yes answer.
----------------------------------------------------------------------------------------------------------------


                               __________

                                                            6/18/09
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
              FLEXIBLE ESOPHAGOGASTRODUODENOSCOPES (EGDS)
                          FY 2007 AND FY 2008
    On the following two pages are the national summary results for 
flexible esophagogastroduodenoscopes (EGDs) from the observational 
assessments conducted in FY 2007 and FY 2008. The results represent the 
percentage of yes or yes in compliance answers that correspond to each 
of the questions contained within the observational assessment (see 
attached spreadsheet). The national results are based on facility and 
VISN submitted reports on the actual observation of staff reprocessing 
a flexible EGD by a four person review team at the facility. The team 
consisted of a Patient Safety Manager, an Infection Control 
Professional, a Quality Management Representative and the Chief of SPD. 
Facility specific results were to be reported to facility management by 
the review team.
    Facility management reported the results to VISN management. VISN 
management reviewed the results and then submitted them to VA Central 
Office. Both facility and VISN management were to review the results 
and develop corrective action plans, if indicated.
    The national summary results of the observational assessments have 
been presented to the following groups by staff from the National 
Infectious Diseases Program: Under Secretary's Coordinating Committee 
on Quality and Safety (USCCQS), National Leadership Board (consisting 
of VISN Directors), VISN Chief Medical Officers, VISN Quality 
Management Officers, VISN Logistics Officers, VISN Patient Safety 
Officers, Facility Chiefs of Supply, Processing and Distribution (SPD) 
and Facility Infection Control Professionals.
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
              FLEXIBLE ESOPHAGOGASTRODUODENOSCOPES (EGDS)
                          FY 2007 AND FY 2008


------------------------------------------------------------------------
                                               FY 07           FY 08
             Question Number              Percentage Yes  Percentage Yes
------------------------------------------------------------------------
 1                                                 1-4 Locations   1-4 Locations
------------------------------------------------------------------------
 2                                                   7%              7%
------------------------------------------------------------------------
 3 SPD                                               21              28
------------------------------------------------------------------------
   OR                                                30              30
------------------------------------------------------------------------
   OP                                                40              43
------------------------------------------------------------------------
   OTHER                                             33              30
------------------------------------------------------------------------
 4                                                   93              95
------------------------------------------------------------------------
 5                                                   74              85
------------------------------------------------------------------------
 6                                                   67              80
------------------------------------------------------------------------
 7                                                   40              67
------------------------------------------------------------------------
 8                                                   68              81
------------------------------------------------------------------------
 9                                                   96              97
------------------------------------------------------------------------
10                                                  100              99
------------------------------------------------------------------------
11                                                   82              92
------------------------------------------------------------------------
12                                                   97              98
------------------------------------------------------------------------
13                                                   97              98
------------------------------------------------------------------------
14                                                  100              99
------------------------------------------------------------------------
15                                                  100              94
------------------------------------------------------------------------
16                                                   67              91
------------------------------------------------------------------------
17                                                   96              98
------------------------------------------------------------------------
18                                                   85              96
------------------------------------------------------------------------
19                                                   86              96
------------------------------------------------------------------------
20                                                   91              97
------------------------------------------------------------------------
21                                                   99              96
------------------------------------------------------------------------
22                                                   NA               7
                                                                 New 08
------------------------------------------------------------------------
23                                                   NA               3
                                                                 New 08
------------------------------------------------------------------------
24                                                   NA               1
                                                                 New 08
------------------------------------------------------------------------
25                                                   NA               4
                                                                 New 08
------------------------------------------------------------------------
26                                                   66              60
------------------------------------------------------------------------
27                                                   42              43
------------------------------------------------------------------------
28                                                   93              94
------------------------------------------------------------------------
29                                                   74              79
------------------------------------------------------------------------
30                                                   90              96
------------------------------------------------------------------------
31                                                  100              99
------------------------------------------------------------------------
32                                                  100             100
------------------------------------------------------------------------
33                                                   46             100
------------------------------------------------------------------------
34                                                   41             100
------------------------------------------------------------------------
35                                                   33              47
------------------------------------------------------------------------
36                                                   87              87
------------------------------------------------------------------------
37                                                   85              87
------------------------------------------------------------------------
38                                                   78              92
------------------------------------------------------------------------
39                                                   64              77
------------------------------------------------------------------------
40                                                  100              99
------------------------------------------------------------------------
41                                                   60              79
------------------------------------------------------------------------
42                                                   81              84
------------------------------------------------------------------------
43                                                   96             100
------------------------------------------------------------------------
44                                                   96              95
------------------------------------------------------------------------
45                                                   83              79
------------------------------------------------------------------------
46                                                   60              77
------------------------------------------------------------------------
47                                                   82              88
------------------------------------------------------------------------
48                                                   90              96
------------------------------------------------------------------------
49                                                   87              90
------------------------------------------------------------------------


                               __________


   VHA National SPD Quality Management Observational Assessment Tool
                         Flexible Bronchoscopes


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Station Number:                                                  November, 2007
-----------------------------------------------------------------------------------
Location of facility (city/state):
-----------------------------------------------------------------------------------
VISN #:
-----------------------------------------------------------------------------------
Name/Title of Contact Person:
-----------------------------------------------------------------------------------
Contact Person's Phone Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  88888This section of the observational assessment will entail a review of a flexible bronchoscope. The
facility review team (the Patient Safety Manager, Infection Control Professional, Quality Management
Representative and Chief of SPD) will need to identify every area in the facility where a flexible bronchoscope
and its components are reprocessed. This will require the review team to coordinate their schedules with staff
in areas where a flexible bronchoscope is reprocessed. The review of flexible bronchoscopes will be limited to
the parent facility and does not include a review of flexible bronchoscopes reprocessed at remote locations,
e.g., community based outpatient clinics. The team is encouraged though to eventually review any reprocessing of
flexible bronchoscopes at remote locations. The team must go to each area at the parent facility where a
flexible bronchoscope is reprocessed and observe firsthand the flexible bronchoscope actually being reprocessed
after use. The team will conduct only one observation per area where the flexible bronchoscope is being
reprocessed.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  The team must inform, in advance, any employee, of their intent to come and observe him/her reprocessing this
flexible bronchoscope. The team must also explain why they are coming and what the observation will entail. The
team must interact with the employee(s) in a collegial and respectful manner. It is recommended that the team go
and look at a flexible bronchoscope and become familiar with it before using this observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Again, the review team must observe staff, who are normally assigned to reprocess flexible bronchoscopes, in
each area at the parent facility where one is reprocessed and separately report the findings for each area.
Flexible bronchoscopes are typically reprocessed in SPD, the Operating Room or an outpatient area, etc. So,
again, the team must identify every area in the parent facility where a flexible bronchoscope is reprocessed and
fill in the columns in the spreadsheet corresponding to each area (see below). The reason this is required is to
observe and assess if reprocessing is being performed correctly, consistently in each area throughout the
facility.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  When observing the flexible bronchoscope being reprocessed the team will ask the employee who is reprocessing
the flexible bronchoscope to describe verbally what he/she is doing as he/she works and why he/she is doing it.
Through this observation and interaction the review team will be able to answer most of the questions in this
section of the observational assessment tool.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  IMPORTANT: The team must not prompt the employee to complete any of the reprocessing steps covered in this
observational assessment tool. The review team's job is to observe whether the employee is actually completing
the reprocessing steps without being prompted. The review team must also actually observe firsthand the employee
performing the work and not ask the employee whether he/she does any of the steps and accept a yes answer.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  1. How many different areas within the parent
facilityarethereinwhich a flexible bronchoscope
is reprocessed? ____ Answer with a number to
indicate how many different areas. If the
answer is zero, then this section is completed.
If the answer is one or more then continue on.
----------------------------------------------------------------------------------------------------------------
  Reminder: The team must complete this observational assessment tool for each area at the parent facility where
a flexible bronchoscope is reprocessed. On the spreadsheet below, there are columns for the different locations
that will need to be filled in based on the answer to this question and question #3 below.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
   Place a ``Y'' or ``N'' in the appropriate
                     block.                       Yes   No
----------------------------------------------------------------------------------------------------------------
  2. Areflexiblebroncho- scopes reprocessed at
remote locations outside of the parent
facility, e.g., community based outpatient
clinics? Yes or No Note: This will require the
review team to contact each location and ask if
flexible bronchoscopes are reprocessed at it.
Again, the review team will NOT be required to
conduct observations at these remote locations
and report on them within this tool. The review
team is encouraged though to eventually review
any reprocessing at these remote locations.
------------------------------------------------------------------------------------------------------------------------
  3. Are flexible bronchoscopes reprocessed at
the parent facility in:
------------------------------------------------------------
  a. SPD  Yes or No
------------------------------------------------------------
  b. The operating room      Yes or No
------------------------------------------------------------
  c. Outpatient area      Yes or No
------------------------------------------------------------
  d. Other _____      Yes or No
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
 Place a ``Y'' or ``N'' in the appropriate      SPD      Operating   Outpatient    Other      Other      Other
   block. Fill in the name of the ``Other   -----------    Room         Area      Location   Location   Location
 Location(s)'' in the appropriate column(s)            -------------------------    ____       ____       ____
    to the right, in which the flexible                                         --------------------------------
 bronchoscope is reprocessed at the parent    Yes   No   Yes   No     Yes    No
                 facility.                                                        Yes   No   Yes   No   Yes   No
----------------------------------------------------------------------------------------------------------------
  4. Were the manufacturer's instructions
for reprocessing the flexible bronchoscope
available for review? Yes or No      Note:
The team should see the document and not
ask whether one exists and accept a yes
answer.
----------------------------------------------------------------------------------------------------------------
  5. Was a local, written standard
operating procedure (SOP) for reprocessing
the flexible broncho-
scopeavailable?YesorNo Note: The team
should see the document and not ask whether
one exists and accept a yes answer.
----------------------------------------------------------------------------------------------------------------
  6. Did the SOP follow the manufacturer's
instructions for reprocessing the flexible
bronchoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  7. Was the SOP approved by the facility's
Infection Control Committee? Yes or No
Note: The team should see an actual
document which indicates it was approved by
the Infection Control Committee.
----------------------------------------------------------------------------------------------------------------
  8. Are current training records available
for each employee who reprocesses
thisflexiblebronchoscope? Yes or No Note:
The team will need to ask for names of
employees who reprocess this flexible
bronchoscope and review training
documentation. To answer yes all training
records must be present and current within
the past year.
----------------------------------------------------------------------------------------------------------------
  9. Was a wet leak test conducted on the
flexible bronchoscope? Yes or No or Not
Applicable (NA). If NA, place an ``NA'' in
the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  10. Was the flexible bronchoscope
disassembled so that all components were
separated for reprocessing? Yes or No or
Not Applicable (NA). If ``NA'', place an
``NA'' in the ``No'' block. Note: Some
flexible bronchoscopes may or may not have
parts that require disassembly. Parts
include, e.g., water, suction and biopsy
ports/covers.
----------------------------------------------------------------------------------------------------------------
  11. Was an enzymatic detergent solution
prepared in accordance with the
manufacturer's instructions? Yes or No
Note: The team will need to review the
manufacturer's instructions for the
enzymatic detergent. The team should ensure
that the detergent being used is an
enzymatic detergent (an enzymatic detergent
removes proteins as well as other material)
and not merely a hospital grade detergent
(which does not remove proteins), and that
it is a combination of both. The team
should not only review how the enzymatic
detergent solution is prepared, but also
what the instructions are for how many
times it can be used before it has to be
changed and what the practice is at the
facility. See question 20 as well.
----------------------------------------------------------------------------------------------------------------
  12. Was the flexible bronchoscope and all
its components, channels and lumens
completely immersed in an enzymatic
detergent to cover all external and
internal surfaces? Yes or No
----------------------------------------------------------------------------------------------------------------
  13. Was the flexible bronchoscope and its
components, channels and lumens cleaned
with an enzymatic detergent, e.g., with a
sponge or brush using mechanical motions,
to ensure bioburden was removed?
Yes or No
----------------------------------------------------------------------------------------------------------------
  14. Was attention given to brushing
internal channels and lumens to ensure
bioburden was removed? Yes or No
----------------------------------------------------------------------------------------------------------------
  15. Were brushes, appropriately sized,
for the internal lumen/channel being
cleaned, being used? Yes or No
----------------------------------------------------------------------------------------------------------------
  16. Were new brushes* used to clean each
flexible bronchoscope? Yes or No Note: The
team is looking to see if the same brushes
are used throughout the day to process
every flexible bronchoscope and its parts
or whether new ones are used for each
flexible bronchoscope processed.
----------------------------------------------------------------------------------------------------------------
  * New brushes are defined as new out of
the package or those that have been through
a sterilization process.
----------------------------------------------------------------------------------------------------------------
  17. Were all internal channels and lumens
flushed with an enzymatic detergent?
Yes or No
----------------------------------------------------------------------------------------------------------------
  18. After processing in the enzymatic
detergent, was the flexible bronchoscope
and its components rinsed with water?
Yes or No
----------------------------------------------------------------------------------------------------------------
  19. After processing in the enzymatic
detergent was the flexible bronchoscope's
internal channels and lumens flushed with
water? Yes or No
----------------------------------------------------------------------------------------------------------------
  20. If indicated in the manufacturer's
instructions, was the enzymatic detergent
changed after eachflexiblebronchoscope was
cleaned? Yes or No or Not Applicable (NA)
Note: The team will need to refer to the
manufacturer's instructions for use. If
``NA'', place ``NA'' in the ``No'' block.
----------------------------------------------------------------------------------------------------------------
  21. Is the sink that is used for the
cleaning processes above cleaned at least
on a daily basis? Yes or No Note: The team
will probably not be able to observe this
being done, but should ask who cleans the
sink and how often is it cleaned.
----------------------------------------------------------------------------------------------------------------
  After the decontamination/cleaning
process, how is the flexible bronchoscope
reprocessed? Answer the following questions
below.
----------------------------------------------------------------------------------------------------------------
  22. Is it sterilized in an ethylene oxide
(EtO) sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  23. Is it sterilized in a steam
sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  24. Is it sterilized in a Sterrad
Sterilizer?
Yes or No
----------------------------------------------------------------------------------------------------------------
  25. If it is sterilized in a Sterrad
Sterilizer, is there written validation
from the manufacturer   of the flexible
bronchoscope on file? Yes or No      Note:
The team should review the actual written
validation.
----------------------------------------------------------------------------------------------------------------
  26. Is it sterilized in a Steris 1
System sterilizer? Yes or No
----------------------------------------------------------------------------------------------------------------
  27. Is it high-level disinfected? Yes or
No
----------------------------------------------------------------------------------------------------------------
  If the answer to question 27 above was
yes, the team needs to complete questions
28-39 below for high-level disinfectant.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 26 above was
yes, the team needs to complete questions
40-49 below for Steris 1 System
sterilizer.
----------------------------------------------------------------------------------------------------------------
  If the answer to question 22 (EtO),
23 (Steam) or 24 (Sterrad Sterilizer)
above was yes, then this section is
complete.
----------------------------------------------------------------------------------------------------------------
          High Level Disinfectant
----------------------------------------------------------------------------------------------------------------
  28. If a high-level disinfectant is used,
was it checked before use in accordance
with the manufacturer's instructions with a
chemical strip to validate its strength to
effectively disinfect?
Yes or No
----------------------------------------------------------------------------------------------------------------
  29. After testing the high-level
disinfectant, was the result recorded and
signed by the person doing the testing? Yes
or No Note: Both recording and signature
must be done to answer ``yes'' to this
question.
----------------------------------------------------------------------------------------------------------------
  30. If high-level disinfectant was used,
was it used in accordance with the
manufacturer's instructions? Yes or No
Note: The team must review the
manufacturer's instructions of the high-
level disinfectant being used. The team is
checking to see what the exposure time is
and whether the scope and its components
were in the high-level disinfectant for the
time period required. The team should ask
how the individual reprocessing the scope
and its components knows that it was
exposed for the required time, e.g., is a
timer and log book used?
----------------------------------------------------------------------------------------------------------------
  31. If high-level disinfectant was used,
was the flexible bronchoscope and its
components completely immersed in it to
cover all external and in-
ternalsurfaces?YesorNo
----------------------------------------------------------------------------------------------------------------
  32. If high-level disinfectant was used,
was attention given to flushing channels
and lumens? Yes or No
----------------------------------------------------------------------------------------------------------------
  33. If high-level disinfectant was used,
was the flexible bronchoscope and all its
components rinsed thoroughly rinsed with
the appropriate type of water according to
the manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  34. If high-level disinfectant was used,
was attention given to flushing/rinsing the
internal channels and lumens of the
flexible bronchoscope with the appropriate
type of water according to the
manufacturer's instructions? Yes or No
----------------------------------------------------------------------------------------------------------------
  35. If high-level disinfectant was used,
and after rinsing/flushing with the
appropriate type of water, was the flexible
bronchoscope and its parts dried with a
sterile towel? Yes or No
----------------------------------------------------------------------------------------------------------------
  36. Was the flexible bronchoscope rinsed
with alcohol, its channels flushed with it
and      then blown out with compressed air
before it was stored if it was not going to
be used within   2 hours? Yes or No
Note: All must be done   to answer yes to
this question.
----------------------------------------------------------------------------------------------------------------
  37. Was the flexible bronchoscope stored
in a clean, closed container or hung
vertically in a clean, closed cabinet
without the end of it touching the bottom
of the cabinet?
Yes or No
----------------------------------------------------------------------------------------------------------------
  38. Was a log maintained to reflect what
specific scopes were reprocessed in high-
level disinfectant? Yes or No Note: The log
should include the serial number of each
scope reprocessed, the date it was
disinfected, and the name of the individual
doing the reprocessing. All must be present
to answer yes to this question.
----------------------------------------------------------------------------------------------------------------
  39. Is the SOP written clearly enough
that the team would be able to take the SOP
and use it to correctly reprocess the
flexible bronchoscope?
Yes or No
----------------------------------------------------------------------------------------------------------------
        Steris 1 System Sterilizer
----------------------------------------------------------------------------------------------------------------
  40. Were all the connectors identified
for the specific scope used to reprocess
the flexible bronchoscope? Yes or No
----------------------------------------------------------------------------------------------------------------
  41. Was the flexible bronchoscope rinsed
with alcohol, its channels/lumens flushed
with it and then blown out with compressed
air before it was stored if it was not
going to be used within   2 hours? Yes or
No      Note: All must be done   to answer
yes to this question.
----------------------------------------------------------------------------------------------------------------
  42. After reprocessing in the Steris 1
System sterilizers was the flexible
bronchoscope stored in a clean, closed
container or hung vertically in a clean,
closed cabinet without the end of it
touching the bottom of the cabinet? Yes or
No
----------------------------------------------------------------------------------------------------------------
  Steris 1 System sterilizers have a
recording device that provides a printed
record that indicates the amount of time
the sterilizer ran and whether sterilant
concentration was met for each cycle. It
must be reviewed by an employee who is
responsible for reprocessing the flexible
bronchoscope and have his/her signature
recorded on it to indicate that it has been
reviewed and meets parameters each time the
sterilizer is used.
----------------------------------------------------------------------------------------------------------------
  The review team must review records for
the past 1-month period for all questions
where indicated so as to have the most
current information.
----------------------------------------------------------------------------------------------------------------
  43. Does the Steris 1 System sterilizer
have a printout for each time it has been
used? Yes or No
----------------------------------------------------------------------------------------------------------------
  44. For each time the Steris 1 System
steri- lizerwasused,diditmeet time and
concentration parameters? Yes or No Note:
The usual cycle time is 28 minutes, but
varies. The team will need to review the
manufacturer's instructions. The printout
will indicate whether the sterilant
concentration was met or not by having,
e.g., aborted, cycle aborted, on it.
Aborted or similar terms mean the cycle was
not completed and the items not sterilized.
The team will need to review the printout
and see what time was reached and recorded
on the printout and if the printout
indicated the cycle was aborted or not.
----------------------------------------------------------------------------------------------------------------
  45. If there were any instances that the
Steris 1 System sterilizer did not meet
parameters, was documentation available to
reflect that actions were taken to
determine the cause, correct it, and that
the flexible bronchoscope was sent back for
another attempt to sterilize it? Yes or No
Note: All must be present to answer ``yes''
to this question.
----------------------------------------------------------------------------------------------------------------
  46. Has each printout been reviewed by
the employee who is responsible for
reprocessing the flexible bronchoscope,
which should be indicated on the printout
by a signature of the person doing the
review? Yes or No Note: The printout is not
to be initialed, it must be signed. The
signature must be legible to identify the
person who reviewed it. The signature must
be the person's usual signature that they
would normally use. The review is to verify
that the parameters have been met.
----------------------------------------------------------------------------------------------------------------
  47. Does the printout include which
specific flexible bronchoscope was
reprocessed in the Steris 1 System
sterilizer? Yes or No Note: In the event a
biological indicator test comes back
positive, then one must be able to know
what specific flexible bronchoscope was
processed in the sterilizer. The printout
must include the scope's serial number. The
serial number is important to have written
on the printout to allow one to be able to
recall the specific scope in the event of a
positive biological indicator and also link
what scope(s) was used on a given
patient(s).
----------------------------------------------------------------------------------------------------------------
  48. Dotherecordsshow that a biological
indicator test was performed at least daily
on days the Steris 1 System sterilizer was
anticipated to be used? Yes or No   Note:
The biological indicator test must include
(1) a biological indicator processed
through the sterilizer with results
recorded and (2) a biological indicator
control that is not processed through the
sterilizer with the results recorded. The
results of the processed biological
indicator must be negative and the results
of the biological indicator control must be
positive. All elements must be present to
answer ``yes'' to this question.
----------------------------------------------------------------------------------------------------------------
  49. Does the facility have local, written
standard operating procedures in the event
of a positive biological indicator with the
Steris 1 System sterilizer? Yes or No
Note: The team should review the document
and not ask whether one exists and accept a
yes answer.
----------------------------------------------------------------------------------------------------------------


                               __________

                                                            6/18/09
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                         FLEXIBLE BRONCHOSCOPES
                          FY 2007 AND FY 2008
    On the following two pages are the national summary results for 
flexible bronchoscopes from the observational assessments conducted in 
FY 2007 and FY 2008. The results represent the percentage of yes or yes 
in compliance answers that correspond to each of the questions 
contained within the observational assessment (see attached 
spreadsheet). The national results are based on facility and VISN 
submitted reports on the actual observation of staff reprocessing a 
flexible bronchoscope by a four person review team at the facility. The 
team consisted of a Patient Safety Manager, an Infection Control 
Professional, a Quality Management Representative and the Chief of SPD. 
Facility specific results were to be reported to facility management by 
the review team.
    Facility management reported the results to VISN management. VISN 
management reviewed the results and then submitted them to VA Central 
Office. Both facility and VISN management were to develop corrective 
action plans, if indicated.
    The national summary results of the observational assessments have 
been presented to the following groups by staff from the National 
Infectious Diseases Program: Under Secretary's Coordinating Committee 
on Quality and Safety (USCCQS), National Leadership Board (consisting 
of VISN Directors), VISN Chief Medical Officers, VISN Quality 
Management Officers, VISN Logistics Officers, VISN Patient Safety 
Officers, Facility Chiefs of Supply, Processing and Distribution (SPD) 
and Facility Infection Control Professionals.
                     DEPARTMENT OF VETERANS AFFAIRS
 NATIONAL SUPPLY, PROCESSING AND DISTRIBUTION (SPD) QUALITY MANAGEMENT 
                 OBSERVATIONAL ASSESSMENT TOOL RESULTS
                         FLEXIBLE BRONCHOSCOPES
                          FY 2007 AND FY 2008


------------------------------------------------------------------------
                                               FY 07           FY 08
             Question Number              Percentage Yes  Percentage Yes
------------------------------------------------------------------------
 1                                                 1-4 Locations   1-4 Locations
------------------------------------------------------------------------
 2                                                   5%              8%
------------------------------------------------------------------------
 3 SPD                                               43              47
------------------------------------------------------------------------
   OR                                                46              37
------------------------------------------------------------------------
   OP                                                35              39
------------------------------------------------------------------------
   OTHER                                             37              26
------------------------------------------------------------------------
 4                                                   82              92
------------------------------------------------------------------------
 5                                                   70              81
------------------------------------------------------------------------
 6                                                   59              83
------------------------------------------------------------------------
 7                                                   36              66
------------------------------------------------------------------------
 8                                                   55              77
------------------------------------------------------------------------
 9                                                   80              94
------------------------------------------------------------------------
10                                                   99              99
------------------------------------------------------------------------
11                                                   73              88
------------------------------------------------------------------------
12                                                   85              95
------------------------------------------------------------------------
13                                                   89              96
------------------------------------------------------------------------
14                                                   96              97
------------------------------------------------------------------------
15                                                   96              96
------------------------------------------------------------------------
16                                                   73              87
------------------------------------------------------------------------
17                                                   89              96
------------------------------------------------------------------------
18                                                   86              93
------------------------------------------------------------------------
19                                                   82              90
------------------------------------------------------------------------
20                                                   90              95
------------------------------------------------------------------------
21                                                   89              92
------------------------------------------------------------------------
22                                                   NA              22
                                                                 New 08
------------------------------------------------------------------------
23                                                   NA               3
                                                                 New 08
------------------------------------------------------------------------
24                                                   NA               1
                                                                 New 08
------------------------------------------------------------------------
25                                                   NA               2
                                                                 New 08
------------------------------------------------------------------------
26                                                   66              69
------------------------------------------------------------------------
27                                                   30              28
------------------------------------------------------------------------
28                                                   89              98
------------------------------------------------------------------------
29                                                   77              88
------------------------------------------------------------------------
30                                                   80              95
------------------------------------------------------------------------
31                                                   96             100
------------------------------------------------------------------------
32                                                   98              98
------------------------------------------------------------------------
33                                                   38              98
------------------------------------------------------------------------
34                                                   36              98
------------------------------------------------------------------------
35                                                   31              66
------------------------------------------------------------------------
36                                                   78              86
------------------------------------------------------------------------
37                                                   89              91
------------------------------------------------------------------------
38                                                   65              67
------------------------------------------------------------------------
39                                                   57              93
------------------------------------------------------------------------
40                                                   98              98
------------------------------------------------------------------------
41                                                   57              77
------------------------------------------------------------------------
42                                                   83              90
------------------------------------------------------------------------
43                                                   98              99
------------------------------------------------------------------------
44                                                   93              93
------------------------------------------------------------------------
45                                                   83              87
------------------------------------------------------------------------
46                                                   58              69
------------------------------------------------------------------------
47                                                   79              85
------------------------------------------------------------------------
48                                                   90              92
------------------------------------------------------------------------
49                                                   88              92
------------------------------------------------------------------------

                                 
