[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
----------
U.S. GOVERNMENT PRINTING OFFICE
51-867 PDF WASHINGTON : 2009
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
DC area (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP,
Washington, DC 20402-0001
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
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
__________
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
------------------------------------------------------------------------