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51–867 2009

ENDOSCOPY PROCEDURES AT 

THE U.S. DEPARTMENT OF VETERANS AFFAIRS: 

WHAT HAPPENED, WHAT HAS CHANGED? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON VETERANS’ AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

JUNE 16, 2009 

Serial No. 111–28 

Printed for the use of the Committee on Veterans’ Affairs 

( 


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COMMITTEE ON VETERANS’ AFFAIRS 

BOB FILNER, California, Chairman 

CORRINE BROWN, Florida 

VIC SNYDER, Arkansas 

MICHAEL H. MICHAUD, Maine 

STEPHANIE HERSETH SANDLIN, South 

Dakota 

HARRY E. MITCHELL, Arizona 

JOHN J. HALL, New York 

DEBORAH L. HALVORSON, Illinois 

THOMAS S.P. PERRIELLO, Virginia 

HARRY TEAGUE, New Mexico 

CIRO D. RODRIGUEZ, Texas 

JOE DONNELLY, Indiana 

JERRY MCNERNEY, California 

ZACHARY T. SPACE, Ohio 

TIMOTHY J. WALZ, Minnesota 

JOHN H. ADLER, New Jersey 

ANN KIRKPATRICK, Arizona 

GLENN C. NYE, Virginia 

STEVE BUYER, Indiana, Ranking 

CLIFF STEARNS, Florida 

JERRY MORAN, Kansas 

HENRY E. BROWN, JR., South Carolina 

JEFF MILLER, Florida 

JOHN BOOZMAN, Arkansas 

BRIAN P. BILBRAY, California 

DOUG LAMBORN, Colorado 

GUS M. BILIRAKIS, Florida 

VERN BUCHANAN, Florida 

DAVID P. ROE, Tennessee 

Malcom A. Shorter, Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

HARRY E. MITCHELL, Arizona, Chairman 

ZACHARY T. SPACE, Ohio 

TIMOTHY J. WALZ, Minnesota 

JOHN H. ADLER, New Jersey 

JOHN J. HALL, New York 

DAVID P. ROE, Tennessee, Ranking 

CLIFF STEARNS, Florida 

BRIAN P. BILBRAY, California 

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. 


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C O N T E N T S 

June 16, 2009 

Page 

Endoscopy Procedures at the U.S. Department of Veterans Affairs: What 

Happened, What Has Changed? ......................................................................... 1 

OPENING STATEMENTS 

Chairman Harry E. Mitchell ................................................................................... 1 

Prepared statement of Chairman Mitchell ..................................................... 50 

Hon. David P. Roe, Ranking Republican Member ................................................ 2 

Prepared statement of Congressman Roe ....................................................... 50 

Hon. Bob Filner ....................................................................................................... 4 

Hon. Steve Buyer ..................................................................................................... 4 

Hon. Timothy J. Walz .............................................................................................. 6 

Hon. Ileana Ros-Lehtinen ....................................................................................... 6 

Hon. Corrine Brown ................................................................................................ 7 

Hon. Paul C. Broun ................................................................................................. 8 

Hon. Bart Gordon .................................................................................................... 8 

Hon. Kendrick B. Meek ........................................................................................... 9 

WITNESSES 

U.S. Department of Veterans Affairs: 

John D. Daigh, Jr., M.D., CPA, Assistant Inspector General for 

Healthcare Inspections, Office of Inspector General .................................. 11 

Prepared statement of Dr. Daigh ............................................................. 51 

William E. Duncan, M.D., Ph.D., MACP, Associate Deputy Under Secretary for Health, Quality and Safety, Veterans Health Administration 30 

Prepared statement of Dr. Duncan .......................................................... 55 

SUBMISSION FOR THE RECORD 

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

statement .............................................................................................................. 62 

MATERIAL SUBMITTED FOR THE RECORD 

Letters: 

Hon. Steve Buyer, Ranking Republican Member, Committee on Veterans’ 

Affairs, to Hon. George Opfer, Inspector General, U.S. Department 

of Veterans Affairs, letter dated March 25, 2009 ....................................... 63 

Hon. George J. Opfer, Inspector General, U.S. Department of Veterans 

Affairs, to Hon. Harry E. Mitchell, Chairman, Subcommittee on Oversight and Investigations, Committee on Veterans’ Affairs, letter dated 

July 23, 2009 [An identical letter was sent to Hon. David P. Roe, 

Ranking Republican Member, Subcommittee on Oversight and Investigations, Committee on Veterans’ Affairs] ................................................. 63 

Post-Hearing Questions and Responses for the Record: 

Hon. Harry E. Mitchell, Chairman, and Hon. David P. Roe, Ranking 

Republican Member, Subcommittee on Oversight and Investigations, 

Committee on Veterans’ Affairs, to Hon. Eric K. Shinseki, Secretary, 

U.S. Department of Veterans Affairs, letter dated June 24, 2009, and 

VA responses ................................................................................................. 64 


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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 


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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. 


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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. 


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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 inciVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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dent 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. 


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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 


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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! 


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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. 


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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 bloodborne 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 


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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 acVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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companied 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. 


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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. 


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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 


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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 reVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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ported 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. 


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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 


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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. 


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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. 


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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. 


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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—— 


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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 


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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 email 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 


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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 HepaVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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titis, 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? 


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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 


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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 Bloodborne 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. 


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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 


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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 


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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 


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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 


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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 


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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. 


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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. 


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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 


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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 


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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 


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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 diVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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rective 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 


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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 


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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. 


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[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 vetVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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erans 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? 


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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 


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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? 


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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. 


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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 selfcertifications. 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 


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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 twoway 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. 


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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 


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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.] 


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(50) 

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. 

f 

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. 


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a Numbers updated as of June 8, 2009, 4:00 p.m. from VA’s Web site. 

1http://www.va.gov/oig/publications/reports-list.asp. 

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. 

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. 

f 

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. 

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. 


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2 VA Handbook 7176, issued in 2002. 

3 NCPS Alert, Proper Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes, 

February 13, 2004. 4 VHA Patient Safety Alert AL09–07, Improper Set-up and Reprocessing of Flexible Endoscope 

Tubing and Accessories, December 22, 2008. 

• 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.’’ 

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. 

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. 

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. 


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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? 


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• 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. 


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f 

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 conVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00059 Fmt 6604 Sfmt 6621 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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tinue 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. 


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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 StepUp 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 


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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 


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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 


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1There 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. 

• 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. 

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? 


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2Seoane-Vazquez E. et al. (2007). Endoscopy-related infections and toxic reactions: an international comparison. Endoscopy 39(8): 742–78. 3See ibid. 4See Seoane-Vazquez E., Rodriguez-Monguio R. (2008). Endoscopy-related infection: relic of 

the past? Curr Opin Infect Dis; 21(4): 362–6. 5See ibid. 6See 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. 

• 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

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. 

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

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. 


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Thank you again for the opportunity to testify. My colleagues and I are prepared 

to answer your questions. 

f 

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. 


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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 

f 

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 

f 

Inspector General 


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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? 


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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; 


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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 reusVerDate Nov 24 2008 08:52 Jan 07, 2010 Jkt 051867 PO 00000 Frm 00070 Fmt 6621 Sfmt 6621 M:\VAJKT\51867.XXX GPO1 PsN: 51867

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able 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 


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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? 


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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 selfassessment 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. 


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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 postmarket device surveillance to include endoscopy issues. 


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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. 


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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? 

llll 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 lllll 

Yes or No 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No 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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 highlevel disinfectant being 

used. The team is checking to see what the exposure time is and whether 

the scope and its components were in the highlevel 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


ebenthall on DSK9Q6SHH1 with HEARING
80 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

45. For each time the 

Steris® 1 System sterilizer was used, did it meet 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
81 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

cystoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. Do the records show 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
82 

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 

Question Number 

FY 07 

Percentage 

Yes 

FY 08 

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 


ebenthall on DSK9Q6SHH1 with HEARING
83 

Question Number 

FY 07 

Percentage 

Yes 

FY 08 

Percentage 

Yes 

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 


ebenthall on DSK9Q6SHH1 with HEARING
84 

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 

facility are there in which 

a flexible colonoscope is 

reprocessed? llll 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
85 

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 lllll 

Yes or No 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No 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 colonoscope available? Yes or No 

Note: The team should 

see the document and not 

ask whether one exists 

and accept a yes answer. 


ebenthall on DSK9Q6SHH1 with HEARING
86 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
87 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


ebenthall on DSK9Q6SHH1 with HEARING
88 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

16. Were new brushes* 

used to clean each flexible colonoscope? Yes or No 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
89 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


ebenthall on DSK9Q6SHH1 with HEARING
90 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 highlevel disinfectant being 

used. The team is checking to see what the exposure time is and whether 

the scope and its components were in the highlevel 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 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 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 


ebenthall on DSK9Q6SHH1 with HEARING
91 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


ebenthall on DSK9Q6SHH1 with HEARING
92 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


ebenthall on DSK9Q6SHH1 with HEARING
93 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

44. For each time the 

Steris® 1 System sterilizer was used, did it meet 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
94 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

colonoscope is reprocessed 

at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. Do the records show 

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. 


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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 

Question Number 

FY 07 

Percentage 

Yes 

FY 08 

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 


ebenthall on DSK9Q6SHH1 with HEARING
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Question Number 

FY 07 

Percentage 

Yes 

FY 08 

Percentage 

Yes 

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 


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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 

facility are there in which 

a flexible EGD is reprocessed? llll 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. 


ebenthall on DSK9Q6SHH1 with HEARING
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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 lllll 

Yes or No 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating 

Room 

Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No 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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. 


ebenthall on DSK9Q6SHH1 with HEARING
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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


ebenthall on DSK9Q6SHH1 with HEARING
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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 highlevel disinfectant being 

used. The team is checking to see what the exposure time is and whether 

the scope and its components were in the highlevel 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 

within 2 hours? Yes or No 

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 


ebenthall on DSK9Q6SHH1 with HEARING
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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

44. For each time the 

Steris® 1 System sterilizer was used, did it meet 

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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

EGD is reprocessed at the 

parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. Do the records show 

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. 


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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 

Question Number 

FY 07 

Percentage 

Yes 

FY 08 

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 


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Question Number 

FY 07 

Percentage 

Yes 

FY 08 

Percentage 

Yes 

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 


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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: 

This 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 

facility are there in which 

a flexible bronchoscope is 

reprocessed? llll 

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. 


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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. Are flexible bronchoscopes 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 lllll 

Yes or No 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No 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 bronchoscope available? Yes or No 

Note: The team should 

see the document and not 

ask whether one exists 

and accept a yes answer. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 

this flexible bronchoscope? 

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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 

each flexible bronchoscope 

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. 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 highlevel disinfectant being 

used. The team is checking to see what the exposure time is and whether 

the scope and its components were in the highlevel 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 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 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes 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 


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Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

44. For each time the 

Steris® 1 System sterilizer was used, did it meet 

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. 


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120 

Place a ‘‘Y’’ or ‘‘N’’ in the 

appropriate block. Fill in 

the name of the ‘‘Other 

Location(s)’’ in the appropriate column(s) to the 

right, in which the flexible 

bronchoscope is reprocessed at the parent facility. 

SPD 

Operating Room Outpatient 

Area 

Other 

Location 

llll 

Other 

Location 

llll 

Other 

Location 

llll 

Yes No Yes No Yes No Yes No Yes No Yes No 

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. Do the records show 

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. 


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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 

Question Number 

FY 07 

Percentage 

Yes 

FY 08 

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 


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Question Number 

FY 07 

Percentage 

Yes 

FY 08 

Percentage 

Yes 

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 

Æ 


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