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S. HRG. 111–177 

HEARING ON OVERSIGHT OF VA QUALITY 

MANAGEMENT ACTIVITIES 

HEARING 

BEFORE THE

COMMITTEE ON VETERANS’ AFFAIRS 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

JUNE 24, 2009 

Printed for the use of the Committee on Veterans’ Affairs 

( 

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate 

(II) 

COMMITTEE ON VETERANS’ AFFAIRS 

DANIEL K. AKAKA, Hawaii, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

PATTY MURRAY, Washington 

BERNARD SANDERS, (I) Vermont 

SHERROD BROWN, Ohio 

JIM WEBB, Virginia 

JON TESTER, Montana 

MARK BEGICH, Alaska 

ROLAND W. BURRIS, Illinois 

ARLEN SPECTER, Pennsylvania 

RICHARD BURR, North Carolina, Ranking 

Member 

LINDSEY O. GRAHAM, South Carolina 

JOHNNY ISAKSON, Georgia 

ROGER F. WICKER, Mississippi 

MIKE JOHANNS, Nebraska 

WILLIAM E. BREW, Staff Director 

LUPE WISSEL, Republican Staff Director 

(III) 

C O N T E N T S 

JUNE 24, 2009 

SENATORS 

Page 

Akaka, Hon. Daniel K., Chairman, U.S. Senator from Hawaii ........................... 1 

Burr, Hon. Richard, Ranking Member, U.S. Senator from North Carolina ....... 1 

Specter, Hon. Arlen, U.S. Senator from Pennsylvania ......................................... 3 

Begich, Hon. Mark, U.S. Senator from Alaska ..................................................... 4 

Tester, Hon. Jon, U.S. Senator from Montana ...................................................... 4 

Isakson, Hon. Johnny, U.S. Senator from Georgia ............................................... 5 

Johanns, Hon. Mike, U.S. Senator from Nebraska ............................................... 20 

WITNESSES 

Nolan, Thomas, Ph.D., Senior Fellow, Institute for Healthcare Improvement .. 5 

Prepared statement .......................................................................................... 7 

Wise, Robert A., M.D., Vice President of Standards and Survey Methods, 

The Joint Commission ......................................................................................... 9 

Prepared statement .......................................................................................... 10 

Watrous, Julie A., RN, MS, Director, Combined Assessment Program, Office 

of Healthcare Inspections, Office of Inspector General, U.S. Department 

of Veterans Affairs; accompanied by John D. Daigh, M.D., Assistant Inspector General for Healthcare Inspections; and Victoria H. Coates, Regional 

Director of the Atlanta Office of Healthcare Inspections .................................. 15 

Prepared statement .......................................................................................... 17 

Cross, Gerald M., M.D., FAAFP, Acting Under Secretary for Health, Veterans 

Health Administration, U.S. Department of Veterans Affairs; accompanied 

by Dr. William E. Duncan, M.D., Ph.D., MACP, Associate Deputy Under 

Secretary for Health for Quality and Safety; Juan A. Morales, RN, MSN, 

Director, Tennessee Valley Healthcare System; Rebecca J. Wiley, Director, 

Charlie Norwood (Augusta) VA Medical Center; and Mary D. Berrocal, 

MBA, Director, Miami VA Healthcare System .................................................. 34 

Prepared statement .......................................................................................... 37 

(1) 

HEARING ON OVERSIGHT OF VA QUALITY 

MANAGEMENT ACTIVITIES 

WEDNESDAY, JUNE 24, 2009 

U.S. SENATE, COMMITTEE ON VETERANS’ AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 9:31 a.m., in room 

418, Russell Senate Office Building, Hon. Daniel K. Akaka, Chairman of the Committee, presiding. 

Present: Senators Akaka, Tester, Begich, Specter, Burr, Isakson, 

and Johanns. 

OPENING STATEMENT OF HON. DANIEL K. AKAKA, CHAIRMAN, 

U.S. SENATOR FROM HAWAII 

Chairman AKAKA. The hearing of the Senate Committee of Veterans Affairs will come to order. 

Let me say that we know of several instances of poor quality care 

including the prostate cancer treatment in Philadelphia. The 

deaths at Marion, Illinois, of course, and at certain facilities which 

failed to clean endoscopes properly, putting veterans at risk for infectious diseases. 

In the case of the cancer treatment, VA contracted with an outside entity for a large sum of money, with the expectation that 

good care would be provided. Good care was not the result and VA 

failed to monitor such care. I want to be clear that each of these 

instances is a breach of our promise to provide the highest quality 

of care to our veterans. 

As I said I would keep my opening statement short, I would like 

to call on our Ranking Member, Senator Burr, for his opening 

statement. 

STATEMENT OF HON. RICHARD BURR, RANKING MEMBER, 

U.S. SENATOR FROM NORTH CAROLINA 

Senator BURR. Thank you Mr. Chairman. Aloha. 

Chairman AKAKA. Thank you. 

Senator BURR. Mr. Chairman, I want to thank you for honoring 

my request from early May and calling what I think is a vitally important hearing about the VA’s improper cleaning of its medical 

equipment. I want to welcome our witnesses today. 

There is a human element to this issue that must not be forgotten or overlooked at all. Those affected are all veterans who served 

their country with honor. 

These are people like Michael Priest, a Navy veteran who had a 

colonoscopy performed at the Murfreesboro VA Medical Center in 

2 

June 2007. Mr. Priest was to submit a statement today about his 

experience, though we haven’t gotten it yet, Mr. Chairman. 

The VA notified Mr. Priest by telephone that he had tested positive for Hepatitis B and HIV. After he came in for more extensive 

tests and treatment, they notified him by phone a week later that 

the first round of tests were inaccurate: he was not infected. 

The lack of sensitivity displayed by VA officials in Mr. Priest’s 

case is troubling, to say the least. There was no formal apology 

issued to him, no phone call from a higher up from the hospital explaining why there was a mix-up, just a single phone call saying, 

‘‘We got it wrong,’’ as if the detail was trivial and not life-impacting. There was this and clinicians informing his wife, who accompanied him for the second test and was also presumed to be infected, that she was on her own when looking for treatment, that 

the VA would not necessarily facilitate for her. 

Simply put, this is an unacceptable way to treat our veterans or 

their families. Unlike Mr. Priest, who was ultimately found to be 

negative for these diseases, 52 of his fellow veterans have tested 

positive. While it is still unclear if the procedures at VA facilities 

are responsible for infection, what is clear is that VA’s practices 

opened the door to exposure. 

Mr. Priest has abandoned the VA health system and is now seeing a private provider. When veterans lose their confidence in the 

VA, then we have all failed in our mission to care for those who 

fought for us. 

Although the VA has been working to restore confidence in their 

services, veterans are still hesitant; and, quite frankly, who can 

blame them? The more I learn about this issue, the more it seems 

to be a case of extreme negligence. 

With multiple past incidents, multiple warning signs, multiple 

patient safety alerts, multiple internal VA directives, widespread 

media attention, an on-going Inspector General’s investigation, and 

pending hearings on the issue, there is no possible justification as 

to why this has still not been corrected. 

I am going to run through a brief timeline, Mr. Chairman. 

March 2003. Patient Safety Advisory issued stated that the auxiliary water channels on endoscopies must be cleaned after each 

use. Again, March 2003. Despite this warning, this was not followed in at least 18 facilities, including Murfreesboro and Miami. 

February 2004. Another alert, this time about using the correct 

connectors. Despite this warning, incorrect connectors were used in 

Murfreesboro. 

Are you noticing a pattern here? I sure am. Since this 2004 February alert, there have been 11 additional Patient Safety Alerts on 

the topic of medical devices and equipment reprocessing. Eleven. 

April 2006. Over 500 Maine veterans are tested due to improper 

disinfection of biopsy needles. Seventeen facilities in 11 States are 

found to have the same problem. 

March 2008. 714 veterans at an Illinois facility put at risk because of improper cleaning of biopsy valves. VA put out a Patient 

Safety Alert in response. 

July 2008. 159 veterans at a North Dakota facility put at risk because of improper cleaning of the ENT endoscopies, strikingly similar to the problem we saw at the Augusta Medical Center. 

3 

As you can see, despite 6 years of warnings about improper 

cleaning of medical devices, we now arrive at the current problem 

that has all of our attention. 

December 2008. In the wake of improper reprocessing at Murfreesboro, another Patient Safety Alert issued. Again, not new 

issues, but issues first brought out in 2003 and 2004. 

February 2009. VA issues another directive, detailing the proper 

procedures for the maintenance of equipment. The IG report shows 

this was ignored by many facilities. 

March 2009. VA conducts a ‘‘Step-Up Week,’’ in which, according 

to a VA press release, VA would focus on ‘‘retraining, accountability, and training of standard operating procedures.’’ The IG reports that this was also ignored at many facilities. 

Mr. Chairman, it is one thing for the VA to discover problems at 

its facilities and disclose them. But that’s only one part of the 

equation. The other part is learning from mistakes so they are not 

repeated. That did not happen. It has not happened to date. 

The IG conducted unannounced visit to a random sample of hospitals on May 13 and 14, and in these visits, less than 50 percent 

of the facilities were able to prove they are doing this right. Thirteen and 14 May. Still after all that has happened to shed light on 

the proper way to do this, they are still not doing it right. 

In the wake of Murfreesboro, we were told that all facilities were 

looking at their procedures and fixing any problems that they had. 

The VHA directive on February 9 was supposed to have codified 

the procedures. The Step-Up Week in early March was supposed to 

have engaged senior hospital management in personally assuring 

that the procedures were being done right; then came the IG’s findings. 

Mr. Chairman, the warning signs were there, but the decision 

not to focus on them and to take corrective action is what we cannot tolerate. That is the culture that must change. 

I look forward to hearing from not only our first panel, but our 

second panel of VA witnesses. I am not satisfied that the larger 

problem of patient safety is being adequately addressed. I hope to 

be convinced today—not for my sake, but the safety of our veterans 

who trust this medical system as their lifeline. 

Mr. Chairman, thank you. 

Chairman AKAKA. Thank you very much Senator Burr. 

And now I would like to call on our Member, Senator Specter, 

for his brief statement. 

STATEMENT OF HON. ARLEN SPECTER, 

U.S. SENATOR FROM PENNSYLVANIA 

Senator SPECTER. Thank you very much, Senator Akaka. Thank 

you Mr. Chairman and Senator Burr for convening this hearing. 

I want to speak briefly about a problem which is very similar 

which has occurred at the Philadelphia Veterans Administration 

Hospital. According to a New York Times article last Sunday, a 

rogue cancer unit at the Philadelphia VA Medical Center botched 

92 of 116 cancer treatments over a span of more than 6 years and 

kept quiet about it. Ninety-two implant errors resulted from a system-wide failure in which the safeguards were ignored. 

4 

The approach is to have seeds the size of a grain of rice permanently inserted into the prostate through needles instead of having 

an operation. And the insertions were to the wrong area. 

I very much appreciate, Mr. Chairman, your authorizing a field 

hearing in Philadelphia, which we have scheduled for next Monday. 

I regret that I cannot stay, as we have an extraordinarily busy 

morning with the live quorum at 10 o’clock and the vote at 11. I 

think, as most everyone knows, there are many committees meeting simultaneously, so we have to be quadruplets really to make 

all of the events. We have invited Dr. Cross to come to Philadelphia 

and I hope he will join us at that time. 

I can’t see all of the nameplates. Is Dr. Cross in the room? Will 

you join us on Monday? 

Dr. CROSS. Sir, if you need me there I will be there. I have a 

family wedding to go to, but if need be, I will skip it. 

Senator SPECTER. Well, I very much appreciate your willingness 

to accommodate our schedule. There’s a tremendous amount of concern in Philadelphia—really more broadly speaking, but certainly 

in Philadelphia—where these implants occurred and I think that 

prompt oversight is something that we ought to do to respond to 

the public concern. 

Thank you very much Mr. Chairman. 

Chairman AKAKA. Thank you very much, Senator Specter, for 

your brief statement. I would now like to call on Senator Begich 

and then we will hear from Senator Tester afterwards. 

STATEMENT OF HON. MARK BEGICH, 

U.S. SENATOR FROM ALASKA 

Senator BEGICH. Mr. Chairman, because of limited time, I will 

bypass my opening statement and look forward to the questions. 

Chairman AKAKA. Thank you. 

Senator Tester. 

STATEMENT OF HON. JON TESTER, 

U.S. SENATOR FROM MONTANA 

Senator TESTER. Thank you, Mr. Chairman. I am going to make 

my statement very, very brief. First of all, thank you all for being 

here. I appreciate it and look forward to a good question and answer session. 

The material I have gotten is, as I read through it, I can only 

draw one conclusion and that is there are some things that have 

been happening that are unacceptable. I think from a medical 

standpoint you probably know that better than I since I’m not in 

that profession, yet I guess it. In the testimony that the panel 

comes forward with, I would just say that I want to know what 

steps have been taken so it doesn’t happen again. I want to know 

what has been done so that there can be internal reporting without 

any doubt about it if people see it. Because people in the medical 

profession, overall—and the VA is no exception—has some pretty 

competent people. They know what is right and they know what is 

wrong. And for this to have happened there absolutely was a 

breakdown in reporting, and there was a breakdown in the overall 

program; and I want to know how it is going to be fixed to elimiVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
5 

nate some of the things that have happened that you guys are 

going to be talking about today. 

With that, Mr. Chairman, I appreciate you having this hearing, 

as always, and I hope we have an opportunity to ask questions at 

the end. This is a very, very, very serious situation, as Senator 

Specter pointed out from his perspective in Pennsylvania. It’s the 

same way across the country. I think that we need to be sure that 

we have done everything possible to make sure our veterans are 

treated the way they are supposed to be treated and not put in 

harm’s way because of poor medical practices. 

Thank you. 

Chairman AKAKA. Thank you very much Senator Tester. 

Senator Isakson. 

STATEMENT OF HON. JOHNNY ISAKSON, 

U.S. SENATOR FROM GEORGIA 

Senator ISAKSON. Thank you very much, Chairman Akaka. I, too, 

will be brief because the testimony is far more important from 

those who came than hearing from us. 

The Charlie Norwood VA Center in Augusta is one of the three 

hospitals where we had, I think, four instances or four cases. Obviously, veterans in Georgia are very concerned and I am very concerned. I have the highest regard for what has been done in Augusta—what they have done regarding seamless transition for the 

wounded warriors who come back to DOD and transfer to VA—has 

been tremendous. They have been real leaders. 

But this is a very, very serious subject and it is very important 

that we have a mechanism of accountability to assure our veterans 

that we are doing everything we can to ensure that all of the equipment and all of the use of equipment is absolutely consistent with 

the highest forms of hygiene and medical science. 

So, Mr. Chairman, I appreciate very much your calling the hearing. I look forward to hearing from the witnesses. 

Chairman AKAKA. Thank you very much, Senator Isakson. 

I want to welcome the witnesses on our first panel. Dr. Tom 

Nolan, a distinguished Senior Fellow with the Institute for Healthcare Improvement will begin our discussion of quality management. Also testifying will be Dr. Robert Wise on behalf of the Joint 

Commission and Ms. Julie Watrous accompanied by Dr. David 

Daigh and Ms. Vicki Coates on behalf of the Office of Inspector 

General. 

I thank all of you for being here this morning. Your full testimony will appear in the record. 

Dr. Nolan will you please begin? 

STATEMENT OF THOMAS NOLAN, PH.D., SENIOR FELLOW, 

INSTITUTE FOR HEALTHCARE IMPROVEMENT 

Mr. NOLAN. Mr. Chairman and Members of the Committee, 

thank you for extending me the privilege of testifying at this hearing on Quality Management on behalf of the Institute for Healthcare Improvement, also known as IHI. I’m a Senior Fellow at IHI. 

IHI is an independent not-for-profit organization helping to lead 

the improvement of health care throughout the world. 

6 

Although modern approaches to quality management originated 

and evolved outside of health care, the application of these methods 

has gained significant traction within health care. Two landmark 

reports issued by the Institute of Medicine, To Err Is Human in 

1999 and Crossing the Quality Chasm in 2001, highlighted the extent of defects in health care in the United States and the opportunity for improvement. The ‘‘Chasm’’ report declared that the performance of any health care system should be evaluated on six dimensions: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The authors of the report recognized that 

these dimensions were an interacting set of qualities that must be 

pursued together and in balance. 

One of the pioneers of quality management was W. Edwards 

Deming. Deming was one of the first theorists to recognize that 

most problems of quality and safety arise because of faults of the 

system rather than because of faults of individuals working in the 

system. 

A simple example illustrates this fundamental principle. Consider how an Automated Teller Machine, or ATM, operates. A customer inserts a bank card, enters the PIN, and then requests an 

amount of money to be dispensed. In one type of machine, the 

money comes out first; once the customer removes the money, the 

bank card comes out. In another type of machine, the bank card 

comes out first; once the customer removes the card, the money 

comes out a simple reversal of steps in the process. 

The choice between these two designs matters. The customer is 

far more likely to forget the bank card at the ATM machine if the 

money comes out first and then the bank card. A directive sent to 

customers to ‘‘please remember your card’’ will not produce a sustained reduction in cards left at the ATM. 

Of course, health care is not banking, but our health care system 

has thousands of similar opportunities for well-meaning but fallible 

humans aiming to cure, comfort, or help veterans to make mistakes 

that harm them. From the viewpoint of quality management, the 

job of health care executives is to ensure design of systems that 

both prevent these errors and mitigate the harm when errors do 

occur. 

By what method? Joseph Juran, another pioneer of modern quality management, outlined three key elements of quality management systems: quality planning or system design; quality control in 

operations; and quality improvement. 

How might these apply to the problem that has recently surfaced 

at VA facilities of contamination in reprocessing of endoscopes? 

Few systems in the U.S. could produce such thorough and insightful reports as the Inspector General’s report on the ‘‘Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities’’ and the ‘‘National Center for Patient Safety Review of Reprocessing Issues.’’ Among other things, the Inspector General’s report 

recommended instituting more reliable processes. The National 

Center for Patient Safety suggested areas of system design that 

would be needed to accomplish a more reliable overall system. 

It is notable, however, that these two reports appear after the 

fact. If instead they were an input to quality planning and system 

design, this would help accomplish one of the key goals of quality 

7 

1Deming WE. Out of the Crisis. Cambridge, MA: MIT Press; 1986. 

management: prevention of defects through design of reliable systems. This is the frontier of quality management in health care. 

How would one know at a VA facility if quality management and 

the resulting high quality were present? One could start by 

ascertaining how the executives and managers view their role in 

quality management. They know the trends in the performance of 

the system through measurement and audit. They invest in improvements to the system. They provide an environment in which 

everyone in the system can improve the processes in which they 

work. They promote cooperation between parts of the system, for 

example, between a hospital and a clinic. 

The Veterans Health Administration has been a leader in applying quality control, modern quality control, and quality improvement. We at IHI believe that the VHA could now lead the country 

into the realm of quality planning and design of a safe system, to 

prevent these problems from happening in the first place. 

Thank you. 

[The prepared statement of Dr. Nolan follows:] 

PREPARED STATEMENT OF THOMAS NOLAN, PH.D., SENIOR FELLOW ON BEHALF OF

THE INSTITUTE FOR HEALTHCARE IMPROVEMENT

Thank you for extending me the privilege of testifying at this hearing on quality 

management on behalf of the Institute for Healthcare Improvement—also known as 

IHI. I am Tom Nolan, Senior Fellow at IHI. IHI is an independent not-for-profit organization helping to lead the improvement of health care throughout the world. 

Founded by a small group of health care leaders in 1991, IHI is based in Cambridge, 

Massachusetts. We work to accelerate improvement by building the will for change, 

cultivating promising ideas for improving patient care and safety, and helping 

health care systems put those ideas into action. IHI employs a core staff of approximately 100 people, along with hundreds of faculty members. We maintain worldwide action- and results-oriented partnerships with thousands of organizations, and 

tens of thousands of individuals, offering comprehensive programs and maintaining 

a large research agenda. Our aim is to improve the lives of patients, the health of 

communities, and the joy of the health care workforce. We believe that, in most settings, this could be accomplished while simultaneously reducing per capita cost. 

Although modern approaches to quality management originated and evolved outside of health care, the application of these methods has gained significant traction 

within health care. Two landmark reports issued by the Institute of Medicine, To 

Err Is Human in 1999 and Crossing the Quality Chasm in 2001, highlighted the extent of defects in health care—and the opportunity for improvement. The ‘‘Chasm 

Report’’ declared that the performance of any health care system should be evaluated on six dimensions: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The authors of the report recognized that these dimensions were 

an interacting set of qualities that must be pursued together and in balance. 

One of the pioneers of quality management was W. Edwards Deming. Deming was 

one of the first theorists to recognize that most problems of quality and safety arise 

because of faults of the system rather than because of faults of individuals working 

in the system.1 A simple example illustrates this fundamental principle. Consider 

how an Automated Teller Machine, or ATM, operates. A customer inserts a bank 

card, enters the PIN, and then requests an amount of money to be dispensed. In 

one type of machine, the money comes out first; once the customer removes the 

money, the bank card comes out. In another type of machine, the bank card comes 

out first; once the customer removes the card, the money comes out—a simple reversal of steps in the process. 

The choice between these two designs matters. The customer is far more likely 

to forget the bank card at the ATM machine if the money comes out first and then 

the bank card. The customer knows how to operate the machine—and suffers a loss 

if he forgets his bank card—but still forgets the bank card if the money comes out 

first. A directive sent to customers to ‘‘please remember your card’’ will not produce 

a sustained reduction in cards left at the ATM. 

8 

2 Juran JM, Godfrey, AB. Juran’s Quality Handbook. 5th ed. New York, NY: McGraw-Hill; 

1999: 2–6. 

Of course, health care is not banking, but our health care system has thousands 

of similar opportunities for well-meaning but fallible humans aiming to cure, comfort, or help patients to make mistakes that harm them. From the viewpoint of quality management, the job of health care executives is to ensure the design of systems 

that both prevent these errors and mitigate the harm when errors do occur. 

By what method? Joseph Juran, another pioneer of modern quality management, 

outlined the three key elements of a quality management system: quality planning 

(system design), quality control in operations, and quality improvement.2

Quality planning includes: 

• Designing processes capable of being executed reliably to meet the needs of customers or produce the desired outcomes; 

• Training and certifying people in the skills necessary to do the work. In health 

care, professional licensure and board certification are ways in which this happens; 

and 

• Understanding the types of defect that are possible in the system and developing a means for the routine tracking of the occurrence of these defects. 

Quality control includes: 

• Tracking performance during routine operations of key factors in the process or 

elements of a clinical guideline; 

• Identifying failures in operation and mitigating the harm caused to patients; 

and 

• Monitoring defects and the trend in their frequency—for example, are drug 

overdoses going up, down, or staying the same? 

Quality improvement includes: 

• Setting priorities for defect reduction; 

• Applying design concepts such as simplification, visual controls, and waste reduction; and 

• Capturing the learning and spreading it to other locations. 

How might this thinking apply to the problem that has recently surfaced in the 

VA of contamination in reprocessing of endoscopes? Few systems in the US could 

produce such thorough and insightful reports as the Inspector General’s report on 

the ‘‘Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities’’ and the ‘‘National Center for Patient Safety Review of Reprocessing Issues.’’ 

Among other things, the Inspector General’s report recommended instituting more 

reliable processes. The National Center for Patient Safety suggested areas of system 

redesign that would be needed to accomplish a more reliable overall system. 

It is notable, however, that these two reports appeared after the fact. If instead 

they were an input to quality planning and system design, this would help accomplish one of the key goals of quality management: prevention of defects through design of reliable systems. This is the frontier of quality management in health care. 

How would one know at a VHA facility if quality management—and the resulting 

high quality—were present? One could start by ascertaining how the executives and 

managers view their role in quality management: 

• They know the trends in the performance of the system through measurement 

and audit. In a system such as the Veterans Health Care system, this would include 

knowing the variation in performance among different VHA sites. 

• They invest in improvements to the system. These investments range from capital investments to install an electronic medical record, to the investment of clinicians’ time to test and implement a protocol for treating heart attack victims effectively, safely, and efficiently. 

• They provide an environment in which everyone in the system can improve the 

processes in which they work. This environment includes the freedom to surface 

problems in the system without fear of retribution. 

• They promote cooperation between parts of the system—for example, between 

a hospital and a clinic, or between the Department of Defense health care system 

and the VHA. 

The Veterans Health Administration has been a leader in applying quality control 

and quality improvement. We at IHI believe that the VHA could now lead the country into the realm of quality planning and design of a safe system, to prevent these 

problems from happening in the first place. 

Resources: IHI Website: www.ihi.org 

9 

Chairman AKAKA. Thank you very much, Dr. Nolan. And now we 

will hear from Dr. Wise. 

STATEMENT OF ROBERT A. WISE, M.D., VICE PRESIDENT OF 

STANDARDS AND SURVEY METHODS, THE JOINT COMMISSION 

Dr. WISE. Mr. Chairman, Ranking Member, and Members of the 

Committee, on behalf of The Joint Commission, thank you for the 

opportunity to testify at this very important hearing. 

The Joint Commission accredits approximately 146 Department 

of Veterans Affairs organizations, including all of its hospitals. We 

strive to ensure that our Nation’s veterans are receiving high quality and safe care. The Joint Commission accreditation is a risk-reduction process, which is designed to assist health care organizations in reducing the safety risks that are ubiquitous in health 

care. 

Providing health care is fundamentally a human endeavor. The 

Joint Commission emphasizes to health care organizations the importance of having a systems approach to the delivery of care that 

requires all staff to work together to create a culture of safety similar to that found in high reliability industries such as nuclear 

power and commercial aviation. 

For example, the systems approach to reducing health care associated infections within health care organizations involves all parts 

of the organizations and all staff—from physicians and nurses to 

housekeeping. 

This systems approach requires organizations to establish a just 

culture in which people feel safe to identify and report errors has 

happened in the VA when problems with cleaning equipment was 

discovered. 

There are five critical components of the hospital accreditation 

program. First is the need to meet evidence-based standards and 

National Patient Safety Goals. Second is the ongoing collection of 

data, such as patient outcomes, complaints, and past survey results. Third is a periodic onsite survey process in which unannounced onsite surveys emphasize the need for organizations to be 

in continuous compliance with all accreditation standards. 

Surveys start with a group of patients and then each patient’s 

experience is traced through the organization. Thus, a surveyor is 

able to both understand the care directly delivered to these patients and how well the services are integrated to produce good 

outcomes. 

Fourth, hospitals are required to complete an annual self-assessment tool regarding its ongoing compliance with Joint Commission 

standards. And last is public access to a robust complaint process 

for families, patients, staff or anyone else who has concerns about 

the care provided at an organization. Raising the bar. 

The Joint Commission helps organizations focus on priority safety issues. Infection prevention remains one of the most challenging 

issues in the safe delivery of health care. The Joint Commission 

has worked closely with both government and professional organizations to identify the most effect ways to use scarce resources to 

reduce the number of HAIs. 

The Joint Commission’s Infection Prevention Standards require 

the creation of a hospital-wide program that addresses the specific 

10 

risks to the organization, which must be re-evaluated and modified 

on a yearly basis. Our surveyors examine a sample of disinfection 

and sterilization processes. While not every type of procedure is reviewed, the overall framework of how the organization manages 

this portion of its infection prevention program is always part of 

accreditation. 

The Joint Commission’s experience with the VA. Because of the 

way the VA is organized, the opportunities exist to achieve high 

quality safe care when compared to other health care organizations. Among the VA’s attributes are a single medical record for 

each patient across all care, an integrated health care system allowing coordination of care, and the ability to standardize medical 

equipment through centralized purchasing. As an example of the 

positive attributes of the VA system, its sophisticated information 

system allowed much of the performance measured data required 

by the Joint Commission to be gathered in an electronic manner, 

which has resulted in almost uniformly strong performance on 

measures pertinent to heart attack, heart failure, pneumonia, and 

surgical infection prevention. 

Furthermore, the power of the VA’s unique environment was 

demonstrated when more than a dozen organizations stepped up to 

describe similar process breakdown in their own facilities. This 

type of self-disclosure is unusual in an industry that too often is 

seen hiding these types of problems. 

What the Joint Commission is doing to improve safety in health 

care. The Joint Commission learns lessons from high-risk industries and from other disciplines such as systems engineering that 

have been successful in creating safe environments as they strive 

toward high reliability of their processes. To create a high reliability organization an attitude of safety must exist through all levels of an organization. This expectation is essential to the Joint 

Commission’s accreditation process and its message. 

The delivery of health care is a complex undertaking that depends on human beings, therefore making it error prone. The Joint 

Commission began years ago to help organizations become safer organizations by expecting cultures of safety. This direction will remain our top priority. 

On behalf of The Joint Commission, I would like to thank you 

again for this opportunity to testify. 

[The prepared statement of Dr. Wise follows:] 

PREPARED STATEMENT OF ROBERT A. WISE, M.D., VICE PRESIDENT OF STANDARDS

AND SURVEY METHODS, THE JOINT COMMISSION

INTRODUCTION

Mr. Chairman, Ranking Member and Members of the Committee, on behalf of The 

Joint Commission, I want to thank you for the opportunity to testify at this very 

important hearing on the Oversight of VA Quality Management Activities. Founded 

in 1951, The Joint Commission is an independent, not-for-profit organization whose 

mission is to continuously improve the safety and quality of care provided to the 

public through the provision of health care accreditation and related services that 

support performance improvement in health care organizations. 

While The Joint Commission has its roots in hospital accreditation, over the years 

it has developed evaluation programs for a diverse array of health care settings. 

Today, The Joint Commission evaluates and accredits approximately 16,000 health 

care organizations and programs in the United States, including ambulatory care, 

11 

behavioral health services, durable medical equipment providers and suppliers, 

home care, hospices, hospitals, laboratories, and long term care facilities. 

The Joint Commission accredits approximately 146 Department of Veterans’ Affairs organizations, including all of its hospitals. In partnership with the Veterans 

Health Administration, the Joint Commission strives to ensure that our Nation’s 

veterans are receiving high quality and safe care. We take situations such as the 

improper cleaning or reprocessing of colonoscopy equipment at VA medical centers 

very seriously and are working with the VA to identify the causes that contributed 

to this problem and to develop solutions so that these problems do not occur again. 

THE JOINT COMMISSION’S ACCREDITATION PROCESS

Joint Commission accreditation is a risk-reduction process. The Joint Commission’s accreditation process is designed to assist healthcare organizations in reducing the ubiquitous safety risks that are an integral part of the delivery of the high 

quality health care found in the United States and to then assess the level of the 

organization’s success. While risk will never be completely removed, organizations 

can be highly successful in substantially reducing, though not eliminating, errors. 

The delivery of health care is complex and is fundamentally a human endeavor. 

The role of The Joint Commission is to help organizations decrease errors through 

compliance with state-of-the-art standards that focus on a ‘‘systems approach’’ to delivering care. The Joint Commission emphasizes to health care organizations the importance of having all staff work together to create a culture of safety, and establishing and maintaining a strong commitment from leadership to evolve toward high 

reliability organizations such as those found in the high risk industries of nuclear 

power and commercial aviation. 

Systems Approach and Culture of Safety 

Joint Commission efforts to improve patient safety in all types of health care organizations are based upon a recognition of the need for organization leaders and 

health care practitioners to adopt a ‘‘systems approach’’ to managing risk and keeping inevitable human error from reaching patients. For example, to help reduce the 

possibility of acquiring and transmitting an infection, organizations need to establish a robust, systematic infection prevention and control program that starts with 

strong expectations from organizational leadership and emphasizes communication 

and collaboration among all parts of the organization. Attempting to eliminate 

healthcare associated infections (HAIs) within health care settings requires attention to the entire care delivery process and involves everyone, from physicians and 

nurses to housekeeping and receptionists. 

This systems approach requires organizations to establish a just culture in which 

people feel safe to systematically identify and report errors and near misses so that 

these events serve as important learning experiences for the organization and its 

staff. The Joint Commission recognizes that the VA is a leader in American medicine in creating such a culture and has spent a great deal of time and effort in creating and maintaining it. A safety-focused learning environment is one in which 

safety is always top of mind and in which there is constant vigilance by the organization’s leaders and staff to identify and eliminate risks. The Joint Commission’s 

standards, survey process, and other quality and safety improvement initiatives are 

designed to stimulate and facilitate the creation of a culture of safety within accredited organizations. 

Accreditation Methods 

The Joint Commission has created a framework to enhance patient safety. The 

critical components needed to achieve lasting improvement in organizational performance include: 

• Evidenced-Based Standards and National Patient Safety Goals: Standards describe the successful operation of administrative and other critical systems of the 

health care organization (e.g., medication management, infection control and prevention, and leadership), while National Patient Safety Goals focus on specific high 

risk processes that directly impact the quality and safety of care delivered to patients (e.g., reduction of central line infections, safe use of anticoagulation medications, reduction of wrong site surgery). These requirements are developed in collaboration with experts and key stakeholders with final review carried out by a Nationwide field engagement. 

• Ongoing Collection of Data: The Joint Commission initiated the first national 

standardized data collection program for hospitals. This program has formed the 

basis for Medicare’s current pay-for-reporting program; the VA has been an active 

participant in this program since its inception. The data collected on each organization reflect the degree to which the organization routinely delivers safe and quality 

12 

health care. Data on sentinel events, patient complaints, past survey results, and 

performance measures are collected on every Joint Commission-accredited healthcare organization and help The Joint Commission focus and drive the onsite assessment. • Periodic Onsite Survey Process: Unannounced onsite surveys emphasize the 

need for organizations to be in continuous compliance with all accreditation standards. The organization’s annual self-assessment augments the onsite survey process. 

Additionally, the availability of data about the performance of an organization gives 

the Joint Commission surveyors an informed method to pick patients in the organization whose experience can highlight how the organization is performing in its delivery of quality and safe medical care; this data allows the surveyors to use the 

important ‘‘tracer methodology’’ tool. By starting with a specially selected patient 

and then ‘‘tracing’’ that patient’s experience through the organization, a surveyor is 

able to both understand the care directly delivered to patients and the integration 

of systems within the organization. For example, a patient with a hospital acquired 

MRSA infection in the ICU will not only reveal how an infectious patient is treated, 

but will also lead the surveyor to appreciate the healthcare organization’s entire infection prevention and control program. 

• Completion of an Annual Self-Assessment Tool: In addition to being assessed for 

compliance with standards during the onsite survey, every health care organization 

is required to complete an annual self-assessment of compliance with all standards. 

Part of that process is an opportunity to discuss questions and concerns with Joint 

Commission staff about the organization’s approach to compliance with the accreditation requirements. 

• Ready Public Access to a Robust Complaint Process: As a way to receive ongoing 

information about the delivery of care at all of the accredited organizations, there 

exists a toll-free complaint hotline, the confidentiality of which is maintained for 

those who report concerns about an accredited organization. This hotline is available 

to patients, families, staff, or anyone else who might have concerns about the care 

provided at an organization. There is a team that investigates all complaints and 

has the resources to do an onsite visit if required. Also, this information becomes 

part of the data used by the Joint Commission to focus the onsite survey. 

RAISING THE BAR

The Issue of Infection Prevention and Control 

Infection prevention and control remains one of the most important issues challenging the safe delivery of health care, and the approach to eliminating infections 

is constantly changing and improving. The Joint Commission is aware of this and 

strives to remain on the cutting edge of initiatives and advancements in this area 

of health care. Since there are numerous ways in which errors may occur in delivering health care, The Joint Commission helps organizations to focus on priority 

areas. For example, The Centers for Disease Control and Prevention (CDC) estimates that tens of thousands of central line-associated bloodstream infections occur 

annually; 12–25% of patients with these infections die. The Joint Commission created a National Patient Safety Goal requiring organizations to implement best practices to prevent central line-associated bloodstream infections. These requirements 

specify steps an organization must take and are based on evidenced-based national 

guidelines (Compendium of Strategies to Prevent Healthcare-Associated Infections 

in Acute Care Hospitals, found at www.shea-online.org/about/compendium.cfm). A 

March 2008 GAO report underscores the importance of providing such explicit implementation guidance to hospitals trying to reduce the transmission of infections. 

For example, the GAO stated that the CDC has over 13 guidelines for hospitals on 

infection control and prevention containing almost 1200 recommended practices. 

However, these practices are not framed for easy implementation and in a manner 

that provides a blueprint for action. The Joint Commission recognizes that many of 

these practices are vague or framed as contingencies (e.g., if this, then maybe that). 

To help to address the GAO’s concern, The Joint Commission was active in the development of the Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals. The Compendium addresses these implementation 

issues to help hospitals be successful in a complex area. 

In regard to the VA’s situation pertaining to the use of colonoscopes, because of 

the complexity of disinfection and sterilization of equipment, the process can be 

error-prone. Though the number of infections resulting from these processes is not 

as high as other sources of HAIs, disinfection and sterilization remains a current 

area of focus. 

The need to decrease the number and seriousness of healthcare associated infections remains a focus of Joint Commission accreditation. In the last several years, 

13 

The Joint Commission has worked closely with both government (e.g., CDC) and 

professional organizations (e.g., SHEA, APIC) to identify the most effective way to 

use scarce resources to mitigate the continuing problem of HAIs. Four infections are 

responsible for the majority of HAIs. The National Patient Safety Goals identify the 

most dangerous of those infections and create the expectation that the organization 

develops processes to significantly lower their incidence in the hospital. 

Simply knowing about problems will not immediately remedy the situation, but 

it is the first step. Usually, an epidemic triggers an investigation and the results 

of that investigation uncover system failures or process breakdowns. For example, 

an outbreak of Hepatitis in Nevada led to an investigation which uncovered the 

reusing of syringes or needles in clinics. In the VA situation, there is no known epidemic; the performance improvement process is working. The VA self-identified a 

process problem, conducted an investigation, and is implementing improvements. 

The lapses that happened within the VA system are probably typical of what may 

be occurring within health care organizations outside of the VA system. The Joint 

Commission will actively disseminate what is being learned from this situation to 

other health care organizations. 

The Infection Prevention and Control Standards stress the fact that everyone who 

works in the organization has a role in infection prevention and control; must be 

given the tools and training necessary to fulfill that role; and must be held accountable for following procedures that minimize risks to patients. In addition, the Infection Prevention and Control Standards require the creation of a program that addresses the specific risks to the organization and which must be re-evaluated and 

modified on a yearly basis. 

A standard part of any infection control and prevention program is the proper 

processing of equipment, devices, and supplies. This would include all surgical 

instruments, scopes, and other equipment. While the frequency of infections directly 

associated with poorly cleaned equipment is not well established (compared to, for 

example, those associated with the insertion of devices in the body), the control and 

prevention of HAIs nevertheless remains an integral part of all infection control 

and prevention programs. The Joint Commission expects organizations to use evidence-based national guidelines when developing infection prevention and control 

activities. The two widely recognized guidelines pertaining to cleaning, disinfecting, 

and sterilizing equipment are the Centers for Disease Control and Prevention’s 

Healthcare Infection Control Practices Advisory Committee’s Guideline for Disinfection and Sterilization in Healthcare Facilities (http://www.cdc.gov/ncidod/ 

dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf, and The Society for Healthcare Epidemiology of America’s Multi-society Guidelines for Reprocessing Flexible Gastrointestinal Endoscopes (http://www.shea-online.org/Assets/files/position_papers/ 

SHEA_endoscopes.pdf). 

It is important to emphasize that, as part of every accreditation survey, the surveyors will examine disinfection and sterilization processes. Surveyors are trained 

to ask health care workers about manufacturer’s instructions and how they process 

medical equipment; observe medical equipment being processed; and review information about parametric, chemical, and biologic indicators. Surveyors are well prepared to review how an organization manages the processing of medical equipment. 

Surveyors receive ongoing training on the proper management and processing of 

medical equipment, and they also have access to infection prevention and control 

experts within The Joint Commission who can guide them while conducting the onsite review. 

A combination of cleaning, decontamination, disinfection, and sterilization methods are used in handling medical equipment. Regardless of the methods required, 

organizations are expected to follow the manufacturer’s guidelines. Additionally, organizations are expected to have an on-going quality control process that ensures 

that proper medical equipment handling protocols are being followed. In a large hospital, there will be many procedures requiring disinfection and sterilization in which 

many staff are involved. So, while not every type of sterilization procedure is reviewed, the overall process of how the organization manages this portion of its infection control and prevention program is always part of an accreditation survey. 

THE JOINT COMMISSION’S EXPERIENCE WITH THE VA

How the VA Differs from Other Health Care Systems 

The Joint Commission has been asked to comment on how the VA health care organizations perform in relation to private health care organizations. Because of 

issues such as confidentiality and limited resources, The Joint Commission does not 

routinely conduct such data analyses. However, because of the way the VA is 

uniquely organized (for example, the integration of care for a single episode is genVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6621 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
14 

erally unique to the VA system), the opportunity exists to achieve high quality, safe 

care when compared to other health care organizations. Among the VA’s positive attributes are the following: 

• A single medical record for each patient across all care settings supporting coordination of care 

• A centralized, integrated health care system allowing coordination of care 

• A standardized credentialing and privileging process for the appointment of 

medical staff 

• The capability to achieve enhanced epidemiology through the integrated medical 

record 

• The ability to standardize medical equipment through centralized purchasing 

• Leadership’s commitment to and support of performance improvement and the 

encouragement of a culture of safety that impacts the entire delivery system 

The power of the VA’s unique environment was demonstrated through its ability 

to reach out to the entire hospital membership once the process breakdown in the 

colonoscopy cleaning process was discovered. That more than a dozen organizations 

stepped up to describe similar process breakdowns in their own facilities is unusual 

in an industry that too often is seen as hiding these types of problems. The advantage of the VA’s medical record system was demonstrated through the identification 

of all of the potentially infected veterans and the seeming ease with which the VA 

contacted those patients with proper next steps. 

The Joint Commission’s Process with the VA 

The Joint Commission’s Office of Quality Monitoring is working with the VA to 

assist with the organizations that are experiencing issues with colonoscope cleaning. 

According to the responses from the organizations to date, no definitive connection 

between the equipment and the positive diagnoses found in patients has been made. 

In addition, prior survey history and prior complaint history were absent any indication of infection control or equipment management problems at any of the three facilities. While the organizations’ responses were thorough and credible, ongoing 

guidance with Joint Commission management and leadership was sought related to 

whether any alternative approaches should be considered due to the common theme 

among these events and with the knowledge that the situation was being addressed 

by the VA at a leadership level. The Joint Commission is continually in communication with the VA regarding this matter, and will ensure through survey and other 

means that follow-up is successful. 

WHAT THE JOINT COMMISSION IS DOING

Complexity of Health Care 

There are a number of industries operating within complex environments that 

have been more successful in avoiding the number and variety of errors that continue to plague the delivery of medical care. Industries such as commercial aviation 

and nuclear power have had similar types of challenges and have been more successful in creating safe environments known as High Reliability Organizations. 

While a complete discussion of what constitutes a High Reliability Organization is 

beyond the scope of this document, it is important to at least list the characteristics 

that are generally associated with organizations that have achieved such a status. 

These five characteristics are: 

• Preoccupation with failure 

• Reluctance to simplify interpretations 

• Sensitivity to operations 

• Commitment to resilience 

• Deference to expertise 

For an organization to incorporate these characteristics into its fabric, an attitude 

of safety must exist through all levels of an organization. While that achievement 

is quite difficult, at a minimum an expectation that the organization will remain 

safe through the use of established tools must be solidly part of the leadership’s attitudes. The expectation that health care organizations continually move toward 

achieving this state of high reliability is at the core of The Joint Commission’s accreditation process and its components. 

The Joint Commission continues to work with the VA in a collaborative and collegial fashion to resolve the VA’s infection prevention and control issues. The Joint 

Commission’s pledge to help health care organizations help patients by providing 

them with useful guidelines and tools (such as the Standards and National Patient 

Safety Goals) drives The Joint Commission to constantly evolve and grow. In addiVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6621 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
15 

tion to disseminating all lessons learned through its interaction with the VA, The 

Joint Commission will: 

• Survey health care organizations using state-of-the-art standards; 

• Guide and educate these organizations on the most critical of issues through the 

National Patient Safety Goals; 

• Launch the Center for Transforming Healthcare which will allow The Joint 

Commission to directly partner with the most innovative and advanced organizations in the country to address the most critical health care issues facing the industry today; 

• Regularly introduce new initiatives to the health care industry, such as the 

forthcoming hand hygiene initiative; 

• Help health care organizations to reach the same high reliability status as the 

commercial aviation and nuclear power industries; 

• Share with the health care industry all lessons learned; 

• Help organizations to provide the highest quality, safest care possible; and 

• Serve and protect patients. 

CONCLUSION

The delivery of health care is a complex undertaking with numerous intricate and 

complicated processes that fundamentally depend upon human beings, which tends 

to make these processes error-prone. The Joint Commission began a number of 

years ago to help organizations become safer environments for patients and staff by 

moving organizations toward establishing cultures of safety that are characterized 

by encouraging the reporting of problems and unsafe practices; prospectively wrapping envelopes of safety systems around high risk processes; and involving all parts 

of the organization in keeping safety top of mind. 

The Joint Commission is pleased that the VA has moved expeditiously in this direction and has spent significant resources on creating the safety infrastructure that 

can take them into the future. We note that it was a VA employee who identified 

the risk to patients and the VA leadership took appropriate action to minimize risks 

for patients being treated at other VA facilities. These types of actions are critical 

to the evolution of a culture of safety. 

On behalf of The Joint Commission, I would like to thank you again for this opportunity to testify. We are firmly committed to working with all of our partners— 

public and private—to ensure continuous improvement in the delivery of safe, quality health care. 

Chairman AKAKA. Thank you very much, Mr. Wise. We have a 

quorum call at 10, so we’re going to recess and be on the floor. Ms. 

Watrous, when we return we will hear your testimony. 

So the Committee stands in recess at the call of the Chair. 

[Recess.] 

Chairman AKAKA. The hearing of the Senate Committee on Veterans’ Affairs will come to order. 

Ms. Watrous, will you please begin with your testimony. 

STATEMENT OF JULIE A. WATROUS, R.N., M.S., DIRECTOR, 

COMBINED ASSESSMENT PROGRAM, OFFICE OF HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR GENERAL, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY JOHN 

DAIGH, M.D., ASSISTANT INSPECTOR GENERAL FOR 

HEALTHCARE; AND VICTORIA COATES, MSW, DIRECTOR, 

ATLANTA REGIONAL OFFICE 

Ms. WATROUS. Mr. Chairman and Members of the Committee, 

thank you for the opportunity to testify today on a subject that is 

very important to all of us and to me personally—Quality Management in the VA. I have worked for over 20 years in the VA to manage and improve the quality and safety of health care for our veterans. 

16 

I will highlight the results of two reports that we have recently 

published in this area. I will also briefly discuss our recent report, 

on the reprocessing of endoscopes. 

VHA employs many thousands of care providers who work everyday to provide high quality health care to our veterans and they 

mostly succeed. VA does some things very well and the quality of 

care in VHA is generally high. However, the controls need to be improved to ensure the consistent delivery of a uniform medical 

benefit. 

I run the Combined Assessment Program (CAP) with site visits 

to each VA facility approximately every 3 years. We cover a variety 

of patient-care administration and quality management topics. We 

have had findings in environmental issues, medication management, and coordination of care, among others. 

In our report, ‘‘Evaluation of Quality Management in VHA Facilities Fiscal Year 2008,’’ we summarize our findings from 44 CAP reviews. Quality management programs were generally comprehensive and effective. Two of the 44 facilities had significant weakness 

in their QM programs, and those were Detroit and St. Louis. Specific recommendations for those two sites addressed peer review, 

adverse event disclosure, and patient safety among other issues. 

Both facilities submitted acceptable action plans and we tracked 

the actions to completion. 

In our report, we recommended that patient complaints be critically analyzed and actions taken when trends are identified. Medication reconciliation needed to be actively monitored, medical 

records needed to be reviewed for inappropriate use of the copy and 

paste function, and a system-wide fix needed to become a high priority. Compliance with moderate sedation monitoring requirements 

needed to be reinforced and the length of privileges granted to physicians needed to match the length of the employment association. 

VHA concurred and submitted an acceptable action plan. 

VHA’s Patient Safety Program is world renowned and has been 

copied in other health care systems. However, there is room for improvement. In our report titled ‘‘Evaluation of VHA’s National Patient Safety Program,’’ we made three recommendations for improvement. All relevant patient data sources needed to be assessed 

for patient safety significance coordinated across the VA’s Quality 

and Safety Programs and used to drive change. 

Organized coordinated oversight of the National Patient Safety 

Program needed to be systematically provided and VHA needed to 

develop a plan to systematically review all aspects of the program 

for efficiency and effectiveness, and revise as needed. VHA concurred and submitted an adequate action plan. 

The third report to discuss today is titled ‘‘Use and Reprocessing 

of Flexible Fiberoptic Endoscopes.’’ This review was a reaction to 

recent events. We reviewed the topic at Murfreesboro, Tennessee, 

Miami, Florida, and Augusta, Georgia, in detail. We also conducted 

unannounced visits to 42 other reprocessing sites to assess the extent of related problems across the system. Dr. Daigh testified on 

this topic before the House Veterans’ Affairs Subcommittee on 

Oversight and Investigation last week. 

In our report we concluded that facilities had not complied with 

directives to ensure appropriate endoscope reprocessing. We also 

17 

noted that the Clinical Risk Assessment and Advisory Board has 

been an effective mechanism for providing guidance on the disclosure of adverse events. We recommended that VHA ensure compliance with relevant directives regarding endoscope reprocessing, explore the possibilities to improve the reliability of endoscope reprocessing, and review the organizational structure and make necessary changes to implement controls that will ensure compliance. 

Mr. chairman, thank you again for the opportunity to appear before the Committee. We would be pleased to take your questions. 

[The prepared statement of Ms. Watrous follows:] 

PREPARED STATEMENT OF JULIE A. WATROUS, RN, MS, DIRECTOR, COMBINED AS- SESSMENT PROGRAM, OFFICE OF HEALTHCARE INSPECTIONS OFFICE OF INSPECTOR

GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS

Mr. Chairman and Members of the Committee, thank you for the opportunity to 

testify today on Quality Management in the Department of Veterans Affairs. I will 

focus on the results of two reports that we recently published in this area (1) 

Healthcare Inspection—Evaluation of Quality Management in Veterans Health Administration Facilities Fiscal Year 2008; and (2) Healthcare Inspection—Evaluation 

of the Veterans Health Administration’s National Patient Safety Program. I will also 

discuss our recent report, Healthcare Inspection—Use and Reprocessing of Flexible 

Fiberoptic Endoscopes at VA Medical Facilities. I am accompanied by Dr. John D. 

Daigh, Assistant Inspector General for Healthcare Inspections, Office of Inspector 

General (OIG) and Victoria H. Coates, Regional Director of the Atlanta Office of 

Healthcare Inspections, OIG. 

BACKGROUND

The Joint Commission (JC), an accrediting body, describes quality management 

(QM) as a continuous process that involves measuring the functioning of important 

patient care processes and services and, when indicated, identifying changes that 

enhance performance. JC conducts triennial surveys at all Veterans Health Administration (VHA) medical facilities. However, external surveyors typically do not focus 

on VHA requirements. Also, the JC changed the focus of their survey process in 

2004, resulting in a reduction in the JC’s onsite attention to those standards that 

define many requirements for an effective QM program. 

Since the early 1970s, VA has required its health care facilities to operate comprehensive QM programs to monitor the quality of care provided to patients and to 

ensure compliance with VA directives and accreditation standards. Several VHA offices have created programs to evaluate and seek improvement in patient care and 

safety. Each of these offices has access to comprehensive patient databases and can 

obtain reports that assess performance against metrics, such as procedure complication rates, surgery waiting times, and patient satisfaction. Some specific programs 

have developed databases tailored for their patient care review needs, such as the 

National Surgical Quality Improvement Program (NSQIP), the Inpatient Evaluation 

Center, and the Cardiac Assessment Reporting and Tracking System. 

In 1999, VHA issued the National Patient Safety Improvement Handbook, which 

established a policy for identifying, reporting, and mitigating vulnerabilities that 

may result in adverse patient events (such as patient falls and medication errors). 

VHA facility staff are expected to identify and report actual adverse patient events. 

Facility patient safety managers (PSMs) prioritize them for severity and probability. 

A root cause analysis (RCA) may be used by facility staff to determine the reasons 

why events occurred and to try to prevent future occurrences. The handbook describes two types of RCAs—aggregated and individual. Aggregated RCAs may be 

used for four events (falls, adverse drug events, parasuicides [actual or attempted 

suicides], and missing patients) for which data are gathered over time and evaluated annually. Individual RCAs are conducted for more serious events. PSMs enter 

adverse event information into the National Center for Patient Safety’s (NCPS) 

database. The NCPS has access to all reported patient adverse events, close calls, 

and RCAs across the VA system. 

The OIG is required by Public Law 100–322, Veterans’ Benefits and Services Act 

of 1988, to oversee VHA’s QM programs at every level. Oversight is provided 

through four different approaches: 

• Combined Assessment Program (CAP) Reviews—These site visits are scheduled 

at each VHA facility approximately every 3 years and cover a variety of patient care 

18 

1 Healthcare Inspection—Evaluation of Quality Management in Veterans Health Administration Facilities Fiscal Year 2008, May 19, 2009. 2 Healthcare Inspection—Evaluation of the Veterans Health Administration’s National Patient 

Safety Program. 

administration and QM topics. The QM program review has been a consistent focus 

during CAP reviews since 1999. • National Reviews—These system-wide reviews vary by topic and scope but have 

repercussions for VHA policies and practices. The review of VHA’s National Patient 

Safety (NPS) Program is an example of a national program review. • Hotline Complaint Inspections—These inspections address complaints made to 

the OIG Hotline. They may address issues at one facility, several facilities, or may 

be wider in scope. • Community Based Outpatient Clinic Reviews (CBOC)—This new program of 

site visits began in April 2009. The goal is to visit all CBOCs over time. A variety 

of quality and safety topics will be covered in these reviews. 

THE EVALUATION OF QUALITY MANAGEMENT IN VHA FACILITIES

The OIG conducted CAP reviews in 44 VA medical facilities during fiscal year 

(FY) 2008. To evaluate QM activities, we interviewed facility directors, chiefs of 

staff, and QM personnel, and we reviewed plans, policies, and other relevant documents. Some of the areas reviewed did not apply to all VHA facilities because of 

differences in functions or frequencies of occurrences. 

The components of a typical QM program are not standardized. For a complete 

list of the program areas we defined to comprise a comprehensive QM program, 

please see our report,1 but some of the areas we chose to include are: 

• QM and Performance Improvement (PI) committees, activities, and teams. • Peer reviews. • Patient complaints management. • Disclosure of adverse events. • Patient safety functions. • Reviews of patient outcomes of resuscitation efforts. • Medical record documentation quality reviews. 

As a result of our review we made five recommendations, which VHA concurred 

with: 

• Patient complaints needed to be critically analyzed and actions taken when 

trends are identified. • Medication reconciliation needed to be actively monitored. • Medical records needed to be reviewed for inappropriate use of the copy and 

paste functions and a system-wide fix needed to be made a high priority. • Compliance with moderate sedation monitoring requirements needed to be reinforced. • The length of privileges granted to physicians needed to match the length of the 

employment association. 

In addition to these five issues, we expressed concern about the following seven 

areas and will continue to monitor them: 

• Adverse event reporting. • Utilization management. • Patient flow. • Peer review. • RCA timeliness. • Implementing and evaluating corrective actions. • Continuous performance monitoring for physicians. 

Although all 44 facilities we reviewed during FY 2008 had established comprehensive QM programs and performed ongoing reviews and analyses of mandatory areas, 

the St. Louis VA Medical Center and John D. Dingell VA Medical Center, Detroit, 

Michigan, had significant weaknesses. While facility senior managers supported 

their QM programs and were actively involved, they needed to implement and/or reinforce efforts to improve action item implementation and evaluation. 

EVALUATION OF VHA’S NATIONAL PATIENT SAFETY PROGRAM

On June 18, 2009, we published the results of our evaluation of VHA’s NSP Program.2 We reviewed the VHA National Patient Safety Improvement Handbook (VHA 

Handbook 1050.01, May 23, 2008), reports, training materials, and other relevant 

documents. We interviewed NCPS staff in July 2008, as well as staff at VA Central 

Office, at the Veteran Integrated Service Network (VISN) level, and at the facility 

19 

3 Healthcare Inspection—Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities, June 16, 2009. 

level. Also, we assessed patient safety review results and feedback gathered from 

VHA facilities during CAP reviews. 

It is important to identify as many safety concerns as possible from all available 

sources in order to understand the magnitude of the concerns and prioritize actions 

to address them. Many programs under the broad umbrella of quality and safety 

have the potential to identify safety issues and adverse events. At the facility level, 

the following programs comprise a partial list: 

• Patient incident reporting. 

• Patient advocate. 

• Peer review. 

• Tort claim information system. 

• Morbidity and mortality conferences. 

• NSQIP. 

• Infection control. 

While some facility staff may share data from these programs to identify patient 

safety issues and events, no such sharing is required by directives. Most of these 

programs require facility data to be entered into databases or sent in reports that 

are available to the responsible program offices at the VA Central Office level. If 

these databases were available to all relevant program offices for use in data analysis, it is possible that resulting actions could improve patient care quality and safety. However, quality and safety information is not always well coordinated among 

VHA entities. 

Patient safety could be improved by better coordinating existing data sources in 

various programs, expanding the identification of patient events through the addition of automated systems, making appropriately identified data available for analysis, and using the data to drive change. High frequency event types should be 

given appropriate attention. 

We found that although the NCPS monitors selected data elements within required processes, it does not provide comprehensive oversight of the NPS Program. 

It is expected that organized, coordinated oversight of VHA programs be provided 

to determine whether policies are effective and relevant or in need of revision. Currently, there appears to be redundancy and lack of role clarity between NCPS and 

VISN staff, resulting in confusion. The NCPS does not document the systematic 

evaluation of required patient safety processes to determine if revision is needed. 

It is a general philosophy of any quality review activity to continually assess and 

seek to improve key processes. We identified the following four areas that would 

benefit from systematic assessment and possible revision. 

• Cumbersome processes and content. 

• Follow-up of action items. 

• Inter-rater reliability. 

• Adverse event disclosure. 

As a result of our review, we made three recommendations: 

• All relevant patient data sources needed to be assessed for patient safety significance, coordinated across VHA’s quality and safety programs, and used to drive 

change. 

• Organized, coordinated oversight of the NPS Program needed to be systematically provided by either the NCPS or another VHA entity. 

• VHA needed to develop a plan to systematically review all aspects of the NPS 

Program for efficiency and effectiveness and make revisions as appropriate. 

VHA concurred with our recommendations and provided an implementation plan 

that is responsive to our recommendations. 

USE AND REPROCESSING OF FLEXIBLE FIBEROPTIC ENDOSCOPES

AT VA MEDICAL FACILITIES

Based on requests from the VA Secretary, the Chairmen and Ranking Members 

of our oversight committees, and other interested Members of Congress, we conducted a review of the reprocessing of endoscopic equipment at several specific VA 

medical centers (VAMCs), and assessed the extent of related problems throughout 

VHA.3 We visited the facilities that had been the subject of considerable media attention: the Bruce W. Carter VAMC in Miami, FL; the Tennessee Valley Healthcare 

System-Alvin C. York Campus in Murfreesboro, TN; and the Charlie Norwood VA 

Medical Center in Augusta, GA. We reviewed applicable regulations, policies, proceVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
20 

dures, guidelines, and conducted unannounced onsite visits at 42 randomly selected 

VHA facilities to examine pertinent endoscope reprocessing documentation. 

We estimated that VA medical facilities: 

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

the time. 

We concluded that facilities did not comply with directives to ensure compliance 

with reprocessing of endoscopes, resulting in a risk of infectious disease to veterans. 

Endoscope reprocessing requires a standardized, monitored approach to ensure that 

these instruments are safe for use in patient care. The failure of medical facilities 

to comply on such a large scale with repeated alerts and directives suggests fundamental defects in organizational structure. 

As a result of our review, we made three recommendations: 

• 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. 

VHA has concurred with our recommendations and will provide an action plan for 

implementation within 30 days. 

CONCLUSION

The OIG works diligently to provide oversight of quality and safety activities and 

programs in VA’s large and complex health care system. While our reports indicate 

that VA has a program in place for quality management and patient safety activities, it is important that VHA and facility senior managers strengthen QM programs through increased compliance with existing Joint Commission standards and 

VHA requirements and continue to improve the NPS Program’s effectiveness and 

oversight. 

When internal controls and supervisory monitoring fail, as in the case of endoscope reprocessing, it is essential that appropriate actions are taken to standardize 

the processes, strengthen the monitoring, and holding staff accountable for performance failures. 

Mr. Chairman, thank you again for this opportunity to appear before the Committee. We would be pleased to answer any questions that you or Members of the 

Committee may have. 

Chairman AKAKA. Thank you very much for your testimony. 

Senator Johanns if you have any opening statement, you may 

give it at this time. 

STATEMENT OF HON. MIKE JOHANNS, 

U.S. SENATOR FROM NEBRASKA 

Senator JOHANNS. Mr. Chairman, if I might, I would like to give 

just a very brief opening statement. 

First of all, I do want to say I am glad to be here. I really appreciate the Chairman calling this hearing. I am especially interested 

to have an opportunity to visit with the witnesses. I appreciate 

your testimony. 

I will tell you as a Member of the Committee I was very concerned about the report that was released by the VA Inspector 

General last week entitled, ‘‘Use and Reprocessing of the Flexible 

Fiberoptic Endoscopes at VA Medical Facilities.’’ It highlighted 

what I would regard as widespread lapses in a standard of equipment handling. The report was initiated after several deeply troubling instance in various VA facilities, which potentially exposed 

veterans to deadly viruses: Hepatitis, HIV. 

The veterans who had sought treatment at the locations were 

called back for testing and some of them discovered that they had 

21 

been infected. The VA Inspector General decided to conduct a more 

widespread survey and its findings were nothing to be proud of. 

Out of the 42 facilities inspected by the IG, less than half were following the correct procedures. I recognize that the failing rates of 

compliance with these two factors does not necessarily mean that 

the equipment was not cleaned properly. It does not necessarily 

mean that the staff do not know how to use the equipment. 

But I think what it does mean is that something is wrong in 

terms of the management of VA, since these lapses occurred after 

the instance of contamination at other VA facilities. They occurred 

after the VA sent out several directives concerning these issues and 

after a lot of media attention. 

I must admit, I do not understand how VA medical facilities were 

not 100 percent alert after all of this. I am sure that by now you 

are familiar with the IG report I am describing—probably very familiar—but I just want to quote one part. ‘‘The failure of medical 

facilities to comply on such a large scale with repeated alerts and 

directives suggest fundamental defects in organizational structure.’’ 

I could not agree more. After the report was released I did write 

a letter to the Secretary outlining my personal concerns. I believe 

we are fortunate to have representatives of non-VA institutions 

who have the best and most timely information about the specific 

challenges facing our veterans who give us their thoughts. Perhaps 

they have some suggestions on how to address the problem. 

I am especially concerned about what I quoted; this structural 

issue really, really worries me. I found as a previous Cabinet Member that those are the most difficult problems to address. So, I am 

very anxious to hear how we fix what we are dealing with in the 

go-forward plan. 

Thank you, Mr. Chairman. 

Chairman AKAKA. Thank you very much, Senator Johanns. 

Now for questions. Dr. Nolan, you made a very good point in 

your testimony when you said that too often we are reacting to 

problems instead of designing our systems to prevent them. How 

would you suggest we restructure our systems to reduce the 

chances of these kinds of errors that are occurring? 

Mr. NOLAN. Well, it starts with aims. We have many, many facilities in the VA system. The question, say of the endoscope reprocessing is, are these problems limited to a few facilities or is it 

systemwide? 

My prediction would be that even the best facilities will not be 

defect free. So, if this is a priority systemwide, my view is that unless we take a design approach—as opposed to each facility fixing 

its own problems we are never going to get to the point where all 

of us want to see this care for our veterans. What would that 

mean? 

It would mean that we design systems that can be executed reliably across the board in different settings. This is not a trivial matter; it is not a matter to be left to individual facilities. In my testimony I mentioned just a small change of whether the bank card 

or the money comes out that can have a big effect. Well, you can 

imagine all of the small changes which can have an effect on this. 

My recommendation would be start with quality design with a 

qualified group of people, including people for facilities. Make sure 

22 

we have processes that can be executed reliably then put the accountability for the quality control and quality improvement on facilities. But if we start going back to each facility we will be back 

in the same situation in the near future. 

Chairman AKAKA. Dr. Wise, in light of some of the problems in 

VA’s quality management as described in the IG reports, will you 

be changing the way in which you evaluate VA and private hospitals? 

Dr. WISE. There has been. Obviously we have taken a lot of this 

information and brought it back to our surveyors. The way we do 

surveys is we have an extensive program on infection control and 

prevention. We tend to be driven by where the scientific evidence 

is, where those scarce resources should be used. 

Currently people talk about the four major causes of infection— 

things like catheter-related, ventilator, et cetera. As we start to 

hear about these other types of processes we need to pull back and 

make decisions of how we should begin to take a look at this which 

is disinfection and sterilization. 

Actually over the last year we have run into significant problems 

around the issues of steam sterilization, which is quite different. It 

is when instruments are then sterilized by steam and brought forward. We now know that there have been significant problems with 

steam sterilization. We are hearing some very concerning issues 

about what is going on with colonoscopies and all endoscopes. 

There is no question now that we are going to pull back and take 

a look at a much broader process, specific to what is happening 

with this area and that will become more of a focus now of our survey. 

Chairman AKAKA. Ms. Watrous, we have heard about the problems with prostate cancer treatments in Philadelphia VA. How did 

the Philadelphia VA Hospital perform during your last inspection? 

Ms. WATROUS. Thank you for that question. We did a CAP review there in September 2007. There were a number of issues that 

we identified needing improvement there including peer review, 

tracking patient complaint data, improving processing time for patient safety reviews called Root Cause Analyses, et cetera. 

There were a total of 12 recommendations that we found there 

at Philadelphia, so they certainly had issues that they needed to 

fix. 

Chairman AKAKA. Dr. Nolan, a recent news story described a 

problem where a doctor from the University of Pennsylvania, who 

was under contract with VA put radioactive implants in the wrong 

place in dozens of prostate cancer patients. Isn’t it part of good 

quality management for a health care system to require proof of 

competency to perform a procedure before privileging a physician 

to do it? 

Mr. NOLAN. Yes, of course, it is part of quality planning and design. I am not particularly familiar with all the details of that incident, but the question becomes, is this particular physician a special case or is the variation in that system in need of redesign? 

Chairman AKAKA. Ms. Watrous, what role has the Veteran Integrated Service Network played in overseeing the quality of health 

care in Veterans Administration and what role do you think they 

should play? 

23 

Ms. WATROUS. Each of the Network offices has a dedicated staff 

person for quality management—a quality management officer. 

They are expected to do oversight of their facilities’—the facilities 

within that network—quality management programs. I know that 

is probably variable across the system. We are actually working on 

a task force with the VHA folks to develop an assessment tool that 

can be used across all of the facilities and all of the network so 

there is more consistency in their quality management programs. 

I do think they have a role to play, an important role. Again, we 

focus on the systems. If the system is in place it is much more likely—an important alert or any kind of new direction coming down 

from headquarters—is more likely to be implemented if we have 

good systems in place. All similarly, if there is an adverse event— 

we all hope that there won’t be—but when there is an adverse 

event, if the systems are in place it is more likely to be identified 

and addressed and, hopefully, a review process put together so that 

that particular event will not repeat itself. 

Chairman AKAKA. Dr. Daigh, do you have any further comments 

on that? 

Dr. DAIGH. Yes, sir I have a few. I would say that I’ve been disappointed at the VISNs ability to influence what happens with respect to the delivery of health care, the quality of health care 

across VISNs. 

We looked at the peer review process sometime ago and there 

was a specific role for VISNs to try to ensure that peer review is 

accomplished in a meaningful way. So, if you have a hospital that 

has a large number of internists, they may well have a pool of physicians who can provide peer review. If you have a hospital that 

has some specialist for which there are not very many, you would 

hope that there would be a system where within the VISN one 

could pool a number of experts who could then provide adequate 

peer review. 

So, from my point of view I think we see hospitals having difficulty individually. We do not see hospitals have difficulty by 

VISNs. So I am not confident that VISNs are appropriately affecting quality of care issues. 

Chairman AKAKA. Thank you. Senator Burr. 

Senator BURR. Thank you Mr. Chairman. Dr. Nolan let me ask 

you to look at the VA in comparison to sort of the private health 

care infrastructure that we have in this country. In the private 

health care system do they routinely not sterilize or disinfect reprocessed devices? 

Mr. NOLAN. Not intentionally. 

Senator BURR. And is it my understanding that a manufacturer 

of a reprocessed device issues with that device their recommendations about sterilization or disinfection and in addition to that 

there is a back up in the application approval process at FDA there 

is also some requirements that FDA issues as to the use of that 

equipment? 

Mr. NOLAN. Yes. 

Senator BURR. So is it safe for everybody to assume that a health 

care professional hired to work with this equipment would either 

know the manufacturer’s recommendation for sterilization/disinfecVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00027 Fmt 6633 Sfmt 6601 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
24 

tion or the FDA’s recommendation that probably dovetails with the 

manufacturers’ for disinfection or sterilization? 

Mr. NOLAN. Well, let’s assume what they may not have is and 

it may not be working in a process which reliably allows them to 

carry out their intention. 

Senator BURR. So why would an institution not require a health 

care professional to follow the manufacturer’s recommended sterilization and/or the FDA’s recommendation? What benefit would 

there be? 

Mr. NOLAN. I cannot see a benefit of requiring and not to follow 

it. The question is are they in systems which allow them to follow 

it reliably? They may be able to follow it 90, 95 percent of the time. 

Senator BURR. Is there a significant cost to the sterilization/disinfection? 

Mr. NOLAN. I am not an expert in disinfections. 

Senator BURR. Dr. Wise can you help me at all? 

Dr. WISE. The types of devices you are talking about are quite 

complicated. Actually some of these colonoscopies will be 20, 25 different steps and the problem is if there are so many changes going 

on in the actual devices that a device that you are using today may 

end up having changes that you are not using—— 

Senator BURR. And in fact, the safety alerts that were put out 

by the VA actually were put out because of changes in certain devices if I understand the chronology of those alerts. 

Dr. WISE. That I am not sure, but I do know that one of the 

things that we are talking about—systems—is that when you are 

dealing with 20–25 steps, you probably need to have something on 

the wall that says, ‘‘here you do this, this, this.’’ It is pretty much 

like a checklist. If you are trying to commit those steps to memory, 

the chance that you are going to miss one or after a while start 

doing the same thing consistently, becomes much higher. 

So, that’s really one of the changes that needs to be made—when 

you walk into one of these types of departments you would see 

that. 

Senator BURR. Well, I will turn to the AIG. I take for granted 

that there was not a step-by-step process clearly visible for individuals to follow. 

Dr. DAIGH. The directive from VHA was that there would be on 

the wall, basically where these reprocessing occurs, the instructions 

for the different kinds of scopes that that facility had. 

Senator BURR. And you found that—— 

Dr. DAIGH. And we found that about 20 percent of the time that 

instruction was not there. So you would think that there was noncompliance about 20 percent of the time for that feature. The second feature was that we would expect that the training records of 

the individuals who actually cleaned the scopes would reflect that 

they had knowledge and expertise to clean the different variety of 

scopes that the facility had and that was not present a significant 

percent of the time. So, only 43 percent of the facilities that we visited met both criteria. 

Senator BURR. According to your report in 1998, a VA panel recommended the creation of the National Center for Patient Safety 

Office and a director was hired shortly thereafter reporting directly 

to the Under Secretary for Health, VA. Your report further states 

25 

that since 2007 the National Center for Patient Safety director has 

been reporting to the Associate Deputy Under Secretary for Health 

and Quality and Safety. 

You get any understanding in your investigation as to why the 

change? 

Dr. DAIGH. We did not explore that administrative change. I 

have no comment on that. 

Senator BURR. OK. I will take it up with the VA, but clearly 

quality and safety seems to have diminished from a standpoint of 

importance given that your recommendation and quick action in 

1998 put it directly under the Under Secretary of Health and now 

we know how—when you sort of knock down the food chain—all of 

a sudden the focus begins to change. 

In your opinion would an organization committed to patient safety lower it’s Safety Office status? 

Dr. DAIGH. I have not discussed with the Under Secretary of 

Health why they made or did not make that change, nor have I discussed with the principals who you are talking about, who either 

manage patient safety or who the Patient Safety Director reports 

to. I take all of those individuals to be serious individuals committed to patient safety; and how VHA determines the structure 

within the organization, I have not been asked to look at and have 

not looked at that. 

Senator BURR. I appreciate that. Mr. Chairman, I will have to 

have a second round with this panel. Let me just say to Dr. Cross 

and his colleagues, I deeply respect the work that they do. Now is 

when I separate the high regard that I hold them in and the functions of the institution, of the agency. This is a very, very serious 

issue. If we were here with one veteran who had been infected because we had not sterilized or disinfected correctly, I would think 

that is important. If it were one, we would be here looking at the 

procedure, and I am not here to highlight the warts at VA. I am 

here after 11 alerts to say enough’s enough. 

I thank the Chair. 

Chairman AKAKA. Thank you very much, Senator Burr. 

Senator Tester. 

Senator TESTER. Thank you, Mr. Chairman. Dr. Daigh, to just 

kind of follow up on some things that you said to some previous 

questions. You said that 20 percent of the hospitals had no instructions on how to use the equipment, 80 percent did; and then you 

said, if I heard you right, 43 percent of the hospitals only had instructions and what I interpret as kind of a job logbook. Is that 

what you meant? 

Dr. DAIGH. When we were asked to look at the endoscopic issue 

at a national level, having looked at three sites in the report it became clear to me that the reprocessing of endoscopes was a high 

risk area. So we then had to come up with a way to try and address it as a national problem. I do not have individuals on my 

team with the knowledge to actually reprocess an endoscope. So we 

read the directives very carefully as to what VHA asks the facilities 

to do and then we checked to see whether they had done two of 

those things. 

Senator TESTER. Procedures. 

26 

Dr. DAIGH. That is correct. So what I am saying is that essentially 80 percent of the time they had the directions on what to do 

and a much lower percent of the time they had the training records 

to demonstrate that the people, or that one person who cleans the 

scopes was adequately trained. 

Senator TESTER. OK. Thanks. Earlier you talked about the fact 

that the VISNs did not have the ability to influence individual hospital quality of care, from your perspective. 

Dr. DAIGH. From my perspective, what I see is difficulty in individual hospitals. The VISNs, in my view, have not stepped in to ensure consistent high quality of care across their facilities. 

Senator TESTER. Is there any recommendation that you would 

have so that those individual hospitals could be influenced in a way 

to follow the procedures? 

Dr. DAIGH. I believe that it would be appropriate to look at the 

organization within hospitals which are now organized very differently—VISNs which are organized very differently—to look at 

the organizational structure and determine if that is best for the 

current needs for VHA. I think at the same time one needs to look 

at the data that you need to capture to manage and look at the 

flow of data through the organization. 

Senator TESTER. Were you able to capture, in fact, whether the 

VHA directives actually got to the hospitals? And if you want to 

defer that you can. 

Dr. DAIGH. I would have to get back to you on that, but I do not 

believe there is any doubt that they got there. I can get back to 

you on that. I will check and if I am in error I will say, but I do 

not believe there was any doubt about that. 

Senator TESTER. Dr. Wise, can you briefly explain how the Joint 

Commission conducts the accreditation surveys? 

Dr. WISE. There are several parts. One is that we are constantly 

collecting information about organizations throughout the cycle. We 

talked about patient complaints and other information that allow 

us to understand what the potential strengths and weaknesses of 

an organization are. When you go into a hospital it is a big place. 

There are a lot of places to look at in a reasonably short period of 

time. So that information allows us to target in on patients who in 

some way are affected by it. 

Senator TESTER. So your standard is zero tolerance? 

Dr. WISE. For an organization to remain accredited it must adhere to all standards a hundred percent of the time. 

Senator TESTER. OK. And is that the same as with the private 

sector? 

Dr. WISE. Yes. They are exactly the same standards. 

Senator TESTER. Exactly the same standards. Have you done any 

evaluations in the private sector? 

Dr. WISE. We look at about over 4,000 hospitals. 

Senator TESTER. Do you see that the VA is—and by the way I 

agree with what Senator Burr said, one case is bad—but I want to 

know where the VA ranks in relationship to the private sector as 

far as occurrences of screw ups in this particular area. 

Dr. WISE. That question was actually asked, to see if we could 

pull the data. We have lots and lots of data. That particular analysis has not been completed; so it is something that we have the 

27 

data for, but not the effort required to do it. So, we do not know. 

But we do know the kinds of infrastructure that exist within the 

VA that does not exist within other parts of the private sector, 

which I had talked about in my testimony, which in fact, gives it 

a leg up in being able to do a whole lot better than many parts of 

the private sector. 

Senator TESTER. OK, I am out of time. I will pass it on. Thank 

you, Mr. Chairman, and I thank the panelists. 

Chairman AKAKA. Thank you very much, Senator Tester. Now 

we can move on to questions from Senator Isakson. 

Senator ISAKSON. Thank you, Mr. Chairman. Following up on 

that question, so there is no relevant data on private sector occurrence of these infections in terms of if it happens at all or how frequent it happens? 

Dr. WISE. We do not have that data at our fingertips through the 

accreditation process, no. 

Senator ISAKSON. Do you have any idea, Dr. Nolan? 

Mr. NOLAN. I do not have the data, no. 

Senator ISAKSON. Ms. Watrous, in terms of the VA in previous 

history, has this type of occurrence happened before? 

Ms. WATROUS. I am sorry, I do not have data for that. 

Dr. DAIGH. What do you mean exactly, sir? Do you mean—— 

Senator ISAKSON. Infection from a procedure—either colonoscopy 

or endoscopy. 

Dr. DAIGH. There have been a number of instances where instruments have not been cleaned or sterilized correctly, leading to 

issues with patients. So, in the prostate biopsy issue, which was 

cited earlier, and certainly with respect to the insertion of cranial 

implants some years ago, there were some issues around that. So 

I am aware of isolated cases where this has occurred, yes, sir. 

Senator ISAKSON. Ms. Watrous, seeing these occurrences at the 

three VA hospitals, you have in place a procedure called CAP— 

Combined Assessment Program? 

Ms. WATROUS. Yes. 

Senator ISAKSON. And those are every 3 years in each facility. Is 

that correct? 

Ms. WATROUS. Yes. 

Senator ISAKSON. Are you now making a specific inspection of the 

disinfecting process of this equipment as a part of that? 

Ms. WATROUS. I believe we will be adding that to our cadre of 

topics, yes. 

Senator ISAKSON. Ms. Coates, I know you are in Georgia. It is 

good to have a hometown person here. Are you in Clermont or are 

you in the regional office in Atlanta? 

Ms. COATES. I am at the regional office on Clermont, yes. 

Senator ISAKSON. Is Augusta VA, the Charlie Norwood Hospital, 

is that in your region? 

Ms. COATES. Yes, sir, it is. 

Senator ISAKSON. Since the incident or instances that took place 

there, has there been a change in procedures or have you implemented a program to prevent the possibility of infection being 

transferred with this type of equipment? 

Ms. COATES. My office has done that. I am working with Ms. 

Watrous to develop and design that for the CAP reviews. 

28 

Senator ISAKSON. Would your office be the appropriate office to 

put in new procedures or direct new procedures? 

Ms. COATES. We would identify issues during our CAP reviews 

and make recommendations to VHA to make improvements. 

Senator ISAKSON. So you are in the process of determining, in 

terms of the CAP inspections, what procedures you are going to 

create to ensure redundant inspections of this type of disinfectant? 

Ms. COATES. Yes. 

Senator ISAKSON. For all VA facilities? 

Ms. COATES. Yes. 

Senator ISAKSON. You have a complaint process, is that correct? 

Dr. DAIGH. Yes, sir, we do. We have a hotline process that is very 

active. 

Senator ISAKSON. You mean you get a lot of calls? 

Dr. DAIGH. Yes, sir. 

Senator ISAKSON. Do you have the personnel necessary to follow 

up on those calls? 

Dr. DAIGH. I am not sure. We have the capability and publish 

about 50 hotline reports a year. We get several thousand calls either by email or telephone a year. Many of those, we refer back to 

VHA’s management one level above the level of the complaint. The 

most serious ones, we address in writing and publish on our Web 

site. 

Senator ISAKSON. To your knowledge, were all of the instances of 

infection in these three facilities self-reported by the facilities or 

did they come to you by virtue of the hotline? 

Dr. DAIGH. In this case, all three were self-reported through VHA 

systems, not primarily through us. 

Senator ISAKSON. Well, I think that is an important quality fact. 

We do not want any mistakes to take place, but we do want to 

have a culture that when a mistake does take place, we take immediate action from a standpoint of the specific case, and also—it 

would seem like in this CAP program—that I would be working as 

fast as I could to have procedures in place so every future inspection would address the disinfecting program on this type of equipment in the hospital. 

Dr. DAIGH. Could I comment, sir? 

Senator ISAKSON. Yes, you can. 

Dr. DAIGH. We have been asked, and will in 90 days, do a followup inspection on this topic. And it has been our general observation 

that when things are really on the front burner and everybody is 

aware of it that VHA then will pay attention to it, and I think it 

is often important to follow up—down the road when the light has 

moved off that a little bit—to look closely at not only the reprocessing of endoscopes but reprocessing of reusable medical equipment. 

So, we will look at it and take a serious long-term look at this. 

Senator ISAKSON. Thank you very much, Mr. Chairman. 

And, Mr. Chairman, if I can, I want to apologize to Rebecca 

Wiley on the second panel, that I may not be back. I do not want 

her to consider that local hometown boy not coming back, but I am 

on the Health Care Committee markup and I have to get back 

there this afternoon. Thank you, Mr. Chairman. 

Chairman AKAKA. Thank you very much for being here, Senator 

Isakson. 

29 

Now we will hear from Senator Johanns. 

Senator JOHANNS. Thank you very much, Mr. Chairman. 

Let me, if I could, start out with the Inspector General here. The 

first thing I would like to say is how much I appreciate your work. 

As you know, I was the Secretary of Agriculture, where I worked 

with an Inspector General, and I always found that her work was 

very, very professional. I will tell you that some of the gray hair 

I have came from the various reports, but I do appreciate the work. 

I quoted from your report here where it said the failure of medical facilities to comply on such a large scale with repeated alerts 

and directives suggests defects in organizational structure. What 

drew my attention to that was, unfortunately, there can be cases 

where an employee is not paying attention for whatever reason. 

Maybe they have had a bad day or a bad night or whatever, and 

something goes wrong, and that is deeply as tragic. But it does not 

imply what you are implying here. 

Talk to me a little bit about that conclusion; why you think that 

in fact is the case; and then I would like you to just give me two 

or three or four, whatever, bullets on how you fix that. If it is really 

a structural problem here, what is your recommendation in terms 

of how to deal with that? 

Dr. DAIGH. So, in response to your question, I do believe it is a 

structural problem. There are, I believe, at least several instances 

we have been dealing with where a directive goes out from VACO 

to the field on things that I think are important wherein compliance is not what one would expect. And so, I do find that to be an 

issue. 

I think that the solution to the problem—and let me also say 

that the current structure of VA, I think, has produced a wonderful 

health care system that produces very high quality care. It also has 

produced a medical record, and I think an excellent culture of safety. I believe the ladies and gentleman behind me have done a wonderful job with that. 

I think the problem, though, now is to stamp out variation in delivery, so that every time you deliver care it is excellent care. 

And there are parts of health care that require intellect and 

thought and planning, and I think those need to be very carefully 

preserved. But there are parts of health care that are a process, almost an industrial process. You order an x-ray of the chest that 

needs to be done correctly, timely, and reported correctly. 

And I think that it is time to take a look at whether the current 

variety of organization within hospitals—some hospitals have a Department of Surgery, a Department of Anesthesia; some hospitals 

have a Surgical Care Line. So, I think the people need to sit down 

and think about what organization would best allow us to drive out 

the variation, and I think that is the troubling part. 

You have wonderful population metrics and variation that troubles us. The variation can never be driven out, but I think there 

are some significant steps to do that. 

I also think the talent exists within VHA to do that. I think that 

the people behind me understand that, recognize that. I just would 

encourage that we move out on that topic. 

30 

Senator JOHANNS. I think the report is very thorough. We can 

read that. We can understand, man, something really went wrong 

here. 

If there is anything I would ask as your office is working to try 

to assist a structural change here that does what you are suggesting—and I agree these things have to be done routinely and 

well each time—is to let us know if this is not being overcome, because if it is not being overcome then you do have a serious problem. You have got a serious management issue. You have got a serious issue in terms of how management is driving this message 

down to the actual care level, and that is what we need to know. 

Like I said, everybody understands a variation. We do not want 

to see it ever, but we can understand it. But if what is happening 

here is variations are occurring because the message is not getting 

down to the care level in terms of what to do, how to do it, and 

when to do it, then that is a very significant issue because this 

problem will not go away. It will just continue to repeat itself over 

and over. 

Then the final thing I wanted to say, Mr. Chairman, is this: what 

worries me about the structural issue in your finding here is what 

else is happening. You know what I am saying? 

If there is a structural issue in the organization, I doubt that you 

just happen to stumble onto the problem that it was causing. I 

worry that there are other issues out there that you have not been 

asked to look at or you have not looked at or audited or whatever, 

that are going to be the subject of another hearing and another 

hearing. So I am hoping you will somehow keep us apprised of 

what we are dealing with and whether you are seeing the change 

that needs to occur to solve the problem. 

Senator BURR [presiding]. Thank you, Senator Johanns. 

I am going to recognize myself. You have not voted, have you? 

Senator JOHANNS. I think we have. Have we been called to a 

vote? 

Senator BURR. We have been called to a vote. You need to leave. 

Senator JOHANNS. I need to get out of here and vote. 

[Laughter.] 

Senator BURR. I will try to fill in until the troops, the cavalry 

come back. 

To those of you from the Inspector General’s Office, in your report, you detailed how in the wake of the January 2006 event with 

reprocessing of prostate biopsy devices VHA had conducted a national review to assess compliance with reprocessing standards. 

You mentioned that all VHA facilities conducted self-assessments, 

and the aggregated results were published in 2007. Tell us what 

was found to be the main conclusions from those assessments. 

Dr. DAIGH. I did not review the conclusion. I do not know the answer to that. 

Senator BURR. In the course of the investigation, did you find 

that the VA had used the results in a constructive manner? 

Dr. DAIGH. I think that the litany of notification to facilities that 

this is a high-risk area and the fact that there had been self-reporting of lack of following the directions at quite a number of facilities 

led us to the conclusion that we needed to take a hard look at what 

was going out universally. So we then had the unannounced inVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00034 Fmt 6633 Sfmt 6601 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
31 

spection to try to determine whether compliance was systemwide 

or not. 

Senator BURR. You know what I am asking here. It is sort of impossible to assess what and if VA took a constructive step in the 

right direction if in fact the IG did not even look at what the reviews were that came back from this internal process. 

I am trying to give the VA a fair opportunity to detect what was 

wrong and begin to try to fix it. Whether that was a structural 

change, I think is in question. But is there any reason for me to 

believe that from the information they gleaned in the 2007 self-assessment, that they learned something and acted on it? 

Dr. DAIGH. I would say that the fact that there were the incidents we described in the report—that would be Miami, Murfreesboro, and Augusta—the repeated notifications of failure to properly 

reprocess ENT scopes at several other sites, the 16 or so sites who 

indicated that they were not following all of the directions with respect to reprocessing led us to the conclusion that whatever had 

happened before was not effective at the current time. And so, I 

think that the facilities did not recognize this to be the high-risk 

area that it was or, as we go through the recent events, there 

should have been a facility or two that had a problem, but there 

were quite a number of facilities that had reprocessing problems. 

Senator BURR. So, in other words, the medical alerts that went 

out were ignored or devalued from a standpoint of importance? 

Dr. DAIGH. I think that it was not appreciated that multiple 

alerts about the same problem or series of problems—not exactly 

the same issue—set up a situation where reprocessing of these instruments was a high-risk area that needed more than just casual 

oversight because of the risk involved in them. Otherwise, there 

would not be so many recurring alerts about these topics. 

Senator BURR. Last week, you released a report evaluating 

VHA’s National Patient Safety Program. I am sort of curious. 

When conducting analysis with a national safety program, you 

made no mention of the multiple alerts that were ignored with respect to endoscopy. Can you share with me why? 

Dr. DAIGH. The issue that we were looking at there was whether 

we thought the effectiveness of that organization could be improved 

or not, and we did not specifically look at the endoscopy alerts at 

the time that we did that report. 

I should say that about 2 years ago we conducted an unannounced review of VHA to see whether or not the facilities had 

complied with the National Patient Safety Alert which dealt with 

the recall of cadaver material to be used in surgery. So an alert 

went out. We then, after a period of time that we thought appropriate for VHA to respond, had a similar unannounced inspection. 

We published that report, and VHA did extraordinarily well. We 

thought they had complied very well with that patient safety alert. 

So, from my point of view, I thought the alerts were, in fact, 

being addressed reasonably and that people were responding to 

them. So these unannounced inspection results are a surprise to 

me, that we found the answer that we did. 

Senator BURR. I guess I am having a little disconnect because in 

the previous question you suggested they were ignored. Yet, in this 

32 

process, the alerts were not important to come to a determination 

about. Is that what I understand? 

Dr. DAIGH. I am suggesting that. Yes. 

Senator BURR. Have there been any personnel actions that have 

been taken throughout VHA in response to any of these mistakes, 

to your knowledge? 

Dr. DAIGH. I am aware of a variety of administrative board actions. I am unaware of the outcome of that human resources effort. 

So, I think the second panel could much better speak to what actions have been taken or not been taken, but I am aware that there 

have been efforts along that pathway. 

Senator BURR. Now the VA has maintained that it is very transparent when it comes to its disclosure of adverse events, even more 

so than the private sector. But in your June 18 report, you detailed 

that during your 2007 VA facility reviews, ‘‘We assessed adverse 

event disclosure and reported weaknesses. We reported that only 

54 percent—21 of 39 facilities—had completed full disclosure.’’ 

Given these facts, what is the IG’s opinion of the VA’s level of 

transparency both with respect to this specific situation as well as 

the overall VA health care system? 

Dr. DAIGH. Let me say that the disclosure policy the VA has, I 

think, leads the country in terms of the requirement to disclose to 

patients when events occur that are not life-threatening, when 

events occur that are life-threatening, and, as a third category, 

when events occur that require the disclosure to a large number of 

people. 

And I believe that when you go back and look at the disclosures 

that have been made—and in this case VHA identified the problem 

and then disclosed to the affected patients that there was a risk— 

I think VHA has been very forthright in their disclosure, both with 

respect to the prostate issue and with respect to this current problem. 

Senator BURR. Dr. Nolan, relative to proper sterilization or disinfection of reusable devices, how many lives need to be at risk before this is a medical problem? 

Mr. NOLAN. Well, any one death or injury is one too many. In 

the Quality Chasm report, Joseph Juran pointed that out. 

Senator BURR. How about from a standpoint of infection? How 

many Hepatitis B or HIV before this is a medical problem? 

Mr. NOLAN. The goal is zero, clearly. 

Senator BURR. That is sort of the way I look at it. 

In conducting the random site visits during the course of your investigation, you visited 42 hospitals specifically to evaluate their 

procedures, if I am correct. You excluded Miami, Murfreesboro, and 

Augusta from the review because you said separate detailed onsite 

inspections were taking place there. I take for granted you meant 

by the IG’s office? 

Dr. DAIGH. Yes. Victoria Coates went to all three of those sites. 

Senator BURR. Could I ask you or her to give more details about 

what the IG is doing to ensure the safety of our veterans at those 

facilities? 

Dr. DAIGH. I think that what we have done is identify clearly to 

the management of those facilities the defects that we found, and 

33 

have strongly encouraged that they comply with the standards that 

are written which should be followed. 

We will also have a follow-up inspection, within 90 days, of 

VHA’s facilities to assess the system’s response to this directive. 

We will also incorporate into our CAP process a look at aspects 

of reusable medical supplies so that this does not go away in 2 or 

3 months; that we continue to track this until we are comfortable 

that everyone has the message and that that is being done well. 

I do not have the power to tell people exactly how to change their 

process or to make personnel changes. We point out to management what we find as problems and ask management to respond. 

Senator BURR. Mr. Chairman, I am nearly done, but I just want 

to follow this up. 

Chairman AKAKA [presiding]. Sure. 

Senator BURR. At what point—and I am talking about these 

three facilities and the continuing inspections—at what point 

would you determine it is appropriate for the IG to release something versus for this to be internal between the IG and the VA in 

hopes that this might be remediated; or are the results of your initial findings made public? 

Dr. DAIGH. I would consider this a hotline in our records. So, 

from my point of view, Congress and the Secretary asked us to look 

at this issue, and so on my books this is a hotline. 

Every hotline that I accept I either publish on our Web site—and 

I would say that that is fully 80 percent of all the hotlines we accept—and then there are a few, say maybe 10 percent or 20 percent, where the allegations are completely unsubstantiated, and to 

publish a series of allegations that are serious and unsubstantiated 

I think is not in the public interest. 

Senator BURR. I would agree. 

Dr. DAIGH. And I close those administratively. 

We have occasionally been asked by Members of Congress about 

those cases, those hotlines, and then we respond appropriately with 

respect to that. But, if my office accepts a report, we put it on the 

Web. 

Senator BURR. I guess my direct question is having noted those 

deficiencies in those three facilities, at what point would it trigger 

you to take a more aggressive stand relative to VA’s remediation 

of the deficiencies? 

Dr. DAIGH. I think that if—yes, I think—— 

Senator BURR. Does it happen voluntarily on your part or does 

it require us to ask you? 

Dr. DAIGH. No, no, no. I think what you are asking is at what 

point would I call the Under Secretary for Health and say, we need 

to do something very quickly and very seriously systemwide to address the issue. 

Let me say that if what we had done in our inspection was to 

actually pull scopes off the wall and inspect them for whether or 

not they were properly cleaned and in proper condition to be used, 

and if I had found in that circumstance that the scopes were not 

appropriate, I would have called and said that patients are clearly 

at risk. 

The review I did looked at administrative compliance. Did you 

have the SOP there? Did your training records reflect that folks 

34 

were trained? That is close to saying that things are not going well, 

but that is not the same as saying that patients are actually at 

risk. 

There are instances where I become aware through the hotline 

process that patients are at risk. I routinely pick up the phone and 

call Dr. Cross in either his current or his prior role, and the response has always been immediately trying to take steps to make 

sure that that risk is immediately mitigated, and that we can then 

work to figure out what the facts are and how to move forward. 

So, I would say over the last 5 or 6 years I have had this job I 

have had that discussion a couple of times a year at least with the 

Under Secretary, the Deputy Under Secretary, or the Chief of Staff 

of VHA, and it has always been a very professional: What do we 

need to do to try to make sure that veterans are not harmed? 

Senator BURR. I thank you. 

I thank the Chair. 

Chairman AKAKA. Thank you very much, Senator Burr. 

I want to thank this first panel very much for your testimony. 

It is good to hear from the Institute, the Commission and also the 

IG’s Office on this. 

We, without question, want to maintain the quality or raise the 

quality of what we are doing for our veterans, and the bottom line 

is our veterans’ well being. We must take greater measures to ensure these problems do not recur. 

So, I want to thank you all for what you are doing and look forward to working with you. Thank you very much. 

Let me introduce the second panel. We will hear from Dr. Gerald 

Cross who is Acting Under Secretary of Health. He is accompanied 

by Dr. William Duncan, Associate Deputy Under Secretary for 

Health, for Quality and Safety. 

Also, we have medical center directors from Murfreesboro, Tennessee, Augusta, Georgia, and Miami, Florida, to respond to questions. VA originally identified problems with the cleaning of endoscopes at these facilities. 

Dr. Cross, thank you very much for being here. Your full testimony will appear in the record and we look forward to your testimony. Will you please begin, Dr. Cross? 

STATEMENT OF GERALD M. CROSS, MD, FAAFP, ACTING 

UNDER SECRETARY FOR HEALTH, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY WILLIAM E. DUNCAN, MD, PhD, MACP, ASSOCIATE DEPUTY UNDER SECRETARY FOR HEALTH FOR QUALITY AND SAFETY; JUAN A. MORALES, RN, MSN, DIRECTOR, VA 

TENNESSEE VALLEY HEALTHCARE SYSTEM; REBECCA J. 

WILEY, DIRECTOR, CHARLIE NORWOOD VA MEDICAL CENTER; AND MARY D. BERROCAL, MBA, DIRECTOR, MIAMI VA 

HEALTH CARE SYSTEM 

Dr. CROSS. Mr. Chairman, my comments were written in regard 

to the original hearing topic which was quality management. I am 

now including comments on quality management, but also endoscopy and brachytherapy. 

Nothing that I am going to say reflects any defensiveness or satisfaction, and, if you hear any hint of pride about our overall proVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6601 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
35 

grams, you will hear nothing but humility and determination in regard to any errors in patient care. My focus, my team’s focus, our 

foremost and always focus is the patient’s well-being. 

VA health care is dedicated to caring for our most honored citizens. Today’s challenge for VA health care is consistency—consistency at all sites of care. In other words, while overall quality is 

above average, a few of our 1,400 facilities have, on occasion, performed poorly on some aspects of care. I am referring to the VA 

sites that self-reported systemic problems with their endoscopy reprocessing or brachytherapy treatment. 

In the vast majority of cases, VA’s experiences and achievements 

have had an extremely positive impact on national health care and 

VA will continue to play a key leadership role in the success of our 

Nation’s health care future. 

There are several reasons for it. First, VA trains a large number 

of our Nation’s health care workers—about 100,000 health care 

workers per year. Second, our research has provided significant 

proportion of our Nation’s medical research advances. In the past 

7 years, VA authors and co-authors have published more than 

46,000 articles, contributing significantly to the world’s library of 

medical knowledge; and that is just the beginning. 

VA also is the innovator of several of the tools that our Nation 

will need to support health care delivery improvements. For example, VA has developed creative techniques to dramatically lower the 

cost of purchasing and distributing medications. Our performance 

management system also holds our senior clinical and administrative leaders accountable for achieving evidence-based quality targets and has led to dramatic improvement across our health care 

system. 

At VA, we have seen time and again that quality and innovation 

go together. Perhaps one of the most famous innovations is our 

world-class electronic health record. The use of the electronic 

health records for all of our patients led to soaring improvements 

in quality of care over the last decade. 

VA innovations enable us to provide superior care to veterans we 

treat. For example, we developed a new system of health care such 

as our National Polytrauma System of Care, telemedicine and teleradiology. We are looking beyond traditional hospitals to a new 

concept: health care centers that will meet the vast majority of patient needs without the expense of a large inpatient facility. Our 

NSQIP program, that stands for National Surgical Quality Improvement Program, which monitors surgical quality is so successful that it has been adopted by others including the American College of Surgeons. 

Mr. Chairman, I provided you and the Members of the Committee a few slides which demonstrate the current state of VA 

health care quality, which I believe is unmatched in the Nation 

today. These slides permit a quality base comparison between VA 

results and others. The slides demonstrate VA’s exceptional record 

with regard to preventive health care including screening for cholesterol, cancer and diabetes. 

Patients report high levels of satisfaction with the care they receive, whether inpatient or outpatient facilities, and the medical 

literature documents these accomplishments. For example, after acVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6601 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
36 

counting for the burden of chronic illness, risk-adjusted mortality 

for older VA patients was almost 30 percent lower than patients 

enrolled in Medicare Advantage. This was published by Dr. Alfredo 

Selim’s research in the Journal of Medical Care in April 2006. 

If you have any specific questions about these slides, I look forward to discussing them after my oral statement. 

As the Nation moves to its health care future, ethics policies, 

such as those developed at VA, should serve as a foundation for organizational responsibility. We have a strong policy of disclosure 

when we do something wrong. We disclose our errors publicly because we believe it promotes the trust of our patients. We believe 

it is the right thing to do. It may be painful, and I can assure it 

is in the short term, but it is the best thing for everyone, particularly for our patients, in the long term. 

This policy of disclosure has been put to the test several times. 

Recently, we discovered that several of our facilities were not following manufacturer instructions for the reprocessing of endoscopes. Last year, we discovered problems with the dosing and follow-up for brachytherapy patients. 

When we found these problems and determined that there was 

a potential risk to patients, we took action. We informed Members 

of Congress. We put information on the internet. We met with veterans service organizations. We contacted patients to come in for 

special follow-up with respect to endoscopy. And, with respect to 

endoscopy, we engaged the Inspector General’s Office. 

What is more, we implemented a corrective plan that goes beyond endoscopy to address more broadly how we use all reusable 

equipment and how it is handled. The plan focuses on training. It 

focuses on standardization, and it focuses on oversight. Further, we 

have devoted additional funding just as of this week, about $26 

million, to upgrade reprocessing equipment. We have been working 

on that plan for some time. 

In regards to brachytherapy, reviews of the program at the 

Philadelphia VAMC, my external experts gave our program high 

marks. Yet, when we noted problems, I directed a review of all 

sites—not just Philadelphia—but all sites providing this therapy. 

We hired a highly regarded radiation oncologist to review our practices, and all of this followed an external assessment in August 

2007 by the American College of Radiation Oncology in which the 

brachytherapy program reviewer gave the quality assurance program high marks and described one portion as the best I have seen 

on any site visit. 

In any case of medical error, our foremost priority is to work 

with individual patients to acknowledge errors when they occur 

and to do all that we can for each patient. We are committed to 

holding our staff accountable for their performance. VHA must ensure compliance with SOPs and encourage those who raise concerns about the quality of care. We need to encourage them and reward them. 

Our patient safety program depends on both external oversight 

and internal self-reports. When our staff members feel that they 

can bring problems forward, we are more likely to hear about those 

problems. That is why we foster a culture of self-reporting. 

37 

Conclusion: In conclusion, Mr. Chairman, quality and innovation 

are important to our Nation’s health care future. VA will continue 

to lead the Nation in these areas. But when problems occur, ethics, 

disclosure, and accountability also are vital to our veterans’ trust 

and our veterans’ care. 

Thank you, sir. 

[The prepared statement of Dr. Cross follows:] 

PREPARED STATEMENT OF GERALD M. CROSS, MD, FAAFP, ACTING UNDER SEC- RETARY FOR HEALTH, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF

VETERANS AFFAIRS

Mr. Chairman, Ranking Member Burr, and Members of the Committee: Thank 

you for providing me this opportunity to discuss the Department of Veterans Affairs’ 

(VA) quality management and safety programs, as well as the facts and circumstances surrounding recent gaps in the reprocessing of endoscopes and how VA’s 

quality management programs responded to this situation. I am accompanied today 

by Dr. William E. Duncan, M.D., Ph.D., MACP, Associate Deputy Under Secretary 

for Health for Quality and Safety; 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 Miami VA Healthcare System. 

Before reviewing the details of the recent shortfalls in VA’s endoscope reprocessing at several of its medical centers, I will review the quality management organizations and activities in place. Quality management is fundamental to VA health care, 

which exists solely to serve our Nation’s Veterans. Professional publications and the 

mainstream media have recognized and lauded our accomplishments in providing 

the best integrated health care in the country. These achievements are possible because of VA’s ability to link four fundamental elements of health care delivery: access by eligible Veterans, regardless of pre-existing condition or ability to pay; systems of care, such as primary care and community-based long term care coordination that focuses on the whole patient; a comprehensive electronic health record that 

follows the patient throughout the continuum of care; and systems of performance 

measurement that ensure consistently safe, high-quality health care. Despite caring 

for patients that are, on average, sicker, older, and less affluent, VA health care 

compares favorably with the best U.S. health care systems. 

VA maintains broad and robust quality management and safety programs that incorporate multiple components, including improvement activities, patient safety reporting and analysis, internal and external reviews including accreditation by recognized professional groups, performance management, close monitoring of patient 

care experiences, evidence-based clinical guidelines, utilization management, risk 

management activities, and a systematic approach to process improvement and redesign. VA tracks more than 250 measures and monitors that are routinely used 

to evaluate processes and outcomes of care, as well as to hold its senior administrative and clinical leaders accountable. Some examples of these measures include 

breast and cervical cancer screening, diabetes exams, hypertension screening, smoking cessation counseling, immunizations and the use of beta blockers after a heart 

attack. Based upon standard benchmarks from other Federal systems and the private sector, the Veterans Health Administration (VHA) has consistently improved 

its performance annually for the past decade on nearly every measure and VHA’s 

performance equals or exceeds the average for commercial health plans, Medicare 

and Medicaid. Veterans’ perceptions of care provided by VHA likewise equal or exceed those in the community on standard measures of patient satisfaction. VA provides this information online (www.qualityofcare.va.gov/home.cfm). This Web site 

provides information on 10 quality measures at the facility, Veterans Integrated 

Service Network (VISN), and national levels and compares VA’s performance with 

other providers; on all 10 measures, VA outperforms its counterparts. 

My testimony today will describe how VA has centralized quality and safety management, how it turns measurement into action, and discuss in detail how VA identified problems in some of its facilities concerning the reprocessing of endoscopic 

equipment, including how VA began and continues to notify patients, and what remedies it has adopted in response to these incidents. 

CENTRALIZING QUALITY AND SAFETY MANAGEMENT

VA has long been a leader in measurement of quality and performance. Our current Performance Measurement System began as the External Peer Review Program in 1992, focusing primarily on compliance with evidence-based guidelines for 

38 

inpatient and outpatient care. Even prior to that, the Continuous Improvement in 

Cardiac Surgery Program (founded 1987) and the National Surgical Quality Improvement Program (1991) developed some of the first tracking systems for risk-adjusted surgical mortality and morbidity to provide VA a comprehensive quality assurance program for surgical services. 

VA established the Office of Quality and Safety on November 16, 2008, to better 

align and integrate ongoing quality and safety activities and to provide senior leaders with trustworthy analysis of quality data and monitors from multiple sources 

in order to drive improvement and transformation throughout VHA. This new Office 

also provided a mechanism to ensure that quality and safety indicators across multiple measurement approaches were being routinely analyzed and trended. This Office consists of three units: the National Center for Patient Safety, the Office of 

Quality and Performance, and the Quality and Safety Analytics unit. 

VA’s National Center for Patient Safety (NCPS) has been in existence since 1999. 

NCPS takes a systems approach to patient safety that is adapted from known high 

reliability organizations such as aviation or nuclear power. These system-level interventions include safety engineering tools (e.g., Root Cause Analysis, Healthcare 

Failure Mode and Effect Analysis), checklist and template-driven approaches to 

standardizing care processes (e.g., Patient Daily Plans, Universal Protocols to Ensuring Correct Surgery and enforce Hand Hygiene guidelines), and leadership training (e.g. Medical Team Training). High reliability organizations align all their activities to create an organizational mindfulness of safety. VA accomplishes this through 

a national, externally validated, organizational safety culture survey. NCPS utilizes 

reports of adverse events and ‘‘close calls’’ from facilities to identify vulnerabilities 

that require intervention. ‘‘Close calls’’ are those events that did not result in significant harm but identified vulnerabilities that, under other circumstances, might have 

resulted in harm. One measure of the dissemination of safety-mindedness is the continued growth in self-reported adverse events and close calls. Since its inception, 

NCPS has conducted Aggregated or Individual Root Cause Analyses that targeted 

over 425,000 adverse events and close calls. Dozens of countries around the world 

recognize this system of analysis and monitoring as a benchmark and have adopted 

it for their own health care systems. 

VA’s Office of Quality and Performance has, since the 1990s, been responsible for 

assessing patient experiences and satisfaction; measuring, analyzing and reporting 

on VA’s performance; identifying and promoting evidence-based practices; monitoring accreditation of facilities and programs, physician credentialing and privileging, peer review and risk management; and supporting utilization management. 

Since 2006, VA has used the Survey of Healthcare Experiences of Patients to track 

patient satisfaction. This year, VA selected a new contractor and a new instrument, 

the Consumer Assessment of Healthcare Providers and Systems (CAHPS), to measure patient satisfaction. The Agency for Healthcare Quality and the Centers for 

Medicare and Medicaid Services developed the CAHPS, which has been widely 

adapted by other health systems. VA made this shift because the CAHPS is a shorter survey, has a wealth of research already available, will improve turnaround reporting of fully adjusted and weighted satisfaction information to the field, and allows benchmark comparisons with private and other Federal health care organizations. Early results suggest VA is outperforming the private sector. Similarly, the 

American Customer Satisfaction Index has shown VA performance to be superior for 

hospital and outpatient care in each of the last 5 years. 

VA’s newest organization, the Office of Quality and Safety Analytics, compiles and 

analyzes quality and safety data from multiple sources and supports education and 

training of quality management professionals across all of VHA. This unit is the 

outgrowth of a national Inpatient Evaluation Center (IPEC) program begun in 2005 

to measure and report risk-adjusted medical or surgical care outcomes, including 

length of stay, use of intensive care units, and rates of complications such as central-line associated bloodstream infections, ventilator associated pneumonia, and venous thromboembolism. IPEC staff generates quarterly reports for all facilities and 

are available to facilitate onsite quality improvement efforts. 

The Office of Quality and Safety seeks input from both internal and external subject matter experts. Many of the country’s leading experts on these issues are VA 

clinicians, who serve on an internal advisory committee. VHA also recently participated in the Institute for Healthcare Improvement’s ‘‘5 Million Lives’’ Campaign. 

FROM MEASUREMENT TO ACTION

VA has set the national standard for quality measurement and transparency, but 

measurement alone is not enough—action is also needed. Last year, VA issued Quality Management Program Directive 2008–061, which emphasized the critical responVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00042 Fmt 6633 Sfmt 6621 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
39 

sibility of facility, VISN, and national leadership to ensure health care is safe, effective, patient-centered, timely, efficient and equitable. It designated that leaders 

must have accountability structures in place, must understand and be able to articulate the flow of quality management within their organizations, and must take 

responsibility for identifying, prioritizing, and coordinating improvement activities 

within their organization. VISNs were tasked with doing an annual evaluation of 

the Quality Management Programs at their facilities, developing action plans for 

identified deficiencies and tracking these until they have been corrected. Networks 

and facilities are held accountable for these measures in their performance plan; the 

Deputy Under Secretary for Health for Operations and Management conducts quarterly reviews with Network Directors to review their progress. Additional interventions may be triggered by specific circumstances—for example, the appointment of 

any VHA physician who meets identified malpractice triggers is subject to mandatory review by the VISN Chief Medical Officer. Facilities with special concerns can 

also undergo a detailed Analytic Site Review coordinated through the VISN office 

and conducted by staff from the Office of the Associate Deputy Under Secretary for 

Health for Quality and Safety. These comprehensive assessments attempt to identify areas of concern by linking and analyzing over a thousand quality metrics in 

multiple domains. Follow up site visits by teams of experts are often initiated as 

a result. 

VA is committed to improving systems and redesigning them when necessary to 

improve the care delivered to patients by engaging front line staff in productive and 

meaningful changes. A national approach to process improvement and redesign, 

known internally as Systems Redesign, is adapting approaches such as Six Sigma, 

Lean Thinking, and International Standards Organization (ISO) Quality Management Systems, all of which are proven tools in highly complex and high reliability 

organizations, to tackle some of the most challenging problems in health care, including optimizing use of staff and beds to avoid delays in emergency rooms, operating rooms, and intensive care units; ensuring critical laboratory values are 

brought to the attention of clinicians responsible for the care of patients immediately; and making care transitions and handoffs—such as when a patient transfers between hospital units, or is discharged home—as safe as possible. We are hiring systems improvement professionals and aligning them with our executives because quality improvement can only be sustained if it is supported by top leadership. We are also establishing our first four Veterans Engineering Resource Centers 

because these partnerships with the Nation’s leading schools of engineering will 

bring critical insights from disciplines not typically used in health care settings. 

These perspectives have particular value in analyzing complex, recurring processes 

such as the sterile reprocessing of medical and diagnostic devices. 

High quality care also demands attention to everyday activities, such as improving hand hygiene practices to reduce health care associated infections and other efforts to prevent the spread of Methicillin-Resistant Staphylococcus Aureus (MRSA) 

in hospitalized patients. VA’s MRSA prevention program has had a significant impact on infection rates, transmission rates, and has been recognized as a national 

model. Falls and pressure ulcers are among the most common inpatient adverse 

events, particularly for older patients, and have the potential to greatly extend a 

hospital stay. VA is deploying special programs to assess and reduce the risk of falls 

and skin breakdown in hospitals across the country. 

Another routine task is the process of verifying the training, licensure, and employment of all licensed, registered and certified health care professionals in VHA, 

including nearly 55,000 licensed independent practitioners and 70,000 non-independent professionals. VA continually improves its process for credentialing and 

privileging health care providers to ensure VHA clinicians meet the highest possible 

standards. Last year, VHA enrolled all licensed independent practitioners in the National Practitioner Data Bank—Health Integrity and Protection Data Bank 

Proactive Disclosure Service, which ensures immediate notification of medical malpractice payments and adverse actions. To ensure VA is aware of any actions taken 

against a physician for all current and previously-held licenses, we monitor physician licensure through the Federation of State Medical Boards’ Disciplinary Alert 

Service. We also obtain confirmation from the Federation of all licenses currently 

or previously held by all physicians who work for VHA (employees and contractors). 

VA has an exceptional program for ensuring patients receive the right medication, 

in the right dose, at the right time through its patient-centric electronic health 

record (EHR). VA’s EHR is supported by the Computerized Patient Record System 

(CPRS), electronic medication order entry, and direct prescription into Pharmacy 

Vista and the Bar Code Medication Administration (BCMA), which has become the 

model for the private sector and foreign countries alike. The EHR also automatically 

checks for allergies or possible drug interactions, further improving patient safety 

40 

and care. VA’s Center for Medication Safety (VAMedSAFE) is a national, comprehensive pharmaco-vigilance program that emphasizes the safe and appropriate 

use of medications. VAMedSAFE utilizes different methods and tools, including passive and active surveillance, to continuously monitor for potential adverse drug reactions. In many instances, VAMedSAFE directly and promptly notifies providers 

across VA’s health care system if patients are at risk. VA has a Memorandum of 

Understanding with the Food and Drug Administration (FDA) that allows close collaboration on specific post-marketing surveillance efforts and other drug and vaccine 

safety projects. These efforts are conducted through FDA’s newly established Sentinel Initiative and the Office of Surveillance and Epidemiology’s Center for Drug 

Safety and Epidemiology Research. Medications and prescriptions are essential to 

effective health care management, but inaccuracies can have severe repercussions. 

In 2008, VA provided approximately 130 million prescriptions to more than 5 million patients. Our error rate for these prescriptions is less than 1 in every 294,000, 

significantly better than the private sector. 

ENDOSCOPE REPROCESSING

Legitimate questions have been raised about the overall quality and safety of VA’s 

care due to inadequate reprocessing of fiber-optic endoscopic equipment at some of 

its facilities. VA’s number one priority is the well being of our Nation’s Veterans, 

and we deeply regret these incidents occurred. 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 

receive medical care. Veterans and their families need to feel confident that when 

they come to VA they are in good hands and that they are being provided consistently safe, high-quality health care. As this incident shows, however, we must consistently challenge ourselves to remain diligent stewards of leading health care initiatives and services. 

Leaders in health care quality have long recognized the challenges of maintaining 

high reliability across complex activities such as endoscope reprocessing in the face 

of production pressure. Although we are not able to provide comparison rates for 

reprocessing discrepancies in non-VA health systems, it is important to emphasize 

that a cornerstone of VA’s quality and safety programs is a commitment to identifying problems, identifying any patients at risk, disclosing any problems to them, 

and offering appropriate testing, counseling and treatment. The reprocessing issues 

identified at our facilities were identified by VA employees committed to quality and 

safety, and we have kept Veterans Service Organizations, the media, and Congress 

informed about this issue as new facts become available. 

Secretary Shinseki has made accountability and transparency top priorities for 

VHA and for the entire Department. It is unacceptable that this has happened and 

the Secretary directed aggressive action to inform, test and support our patients. We 

will use this unfortunate experience to understand how we can transform our Department. VA is a results-driven organization that learns from its mistakes. Everyday we need to push ourselves to better serve and care 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 

necessary corrective actions in a firm, responsible fashion. We will do this while continuing to maintain an environment that encourages all staff to identify concerns 

that impact the care and safety of our Veterans. 

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 never 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. 

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 

41 

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. 

There were other facilities where there was inadequate reprocessing of endoscopes 

but, after review, it was determined that the risk of harm to patients at these facilities was so remote that it did not justify informing patients. 

BACKGROUND

Endoscopes are small diameter devices that allow a physician to see internal organs through external orifices by utilizing a system of optics. There are many different types of flexible and rigid endoscopes. The endoscopes discussed below are inserted either through the nose or mouth to visualize the esophagus, nasal passages, 

lung, stomach and upper part of the small intestine, or they are inserted through 

the rectum to visualize the colon. Some of these endoscopes used for colonoscopies 

have an internal tube that allows the physician to inject a stream of water through 

the endoscope to flush away any material that might obstruct adequate visualization of the colon. 

Flexible endoscopes are complex devices that need to be reprocessed before they 

can be used again safely. Reprocessing procedures are defined by the endoscope 

manufacturer and generally involve careful cleaning of the entire external and internal surfaces with an appropriate cleaner, brushing any interior channels, and subjecting the entire scope to high level disinfection or sterilization as recommended in 

the manufacturer’s instructions. 

DISCOVERING THE PROBLEMS

On Monday, December 1, 2008, at the Tennessee Valley Health Care System, 

Alvin C. York (Murfreesboro) VA Medical Center (VAMC) in Tennessee, VA staff observed during the third endoscopic colonoscopy of the day a discoloration in the tubing that supplies water to flush the colonoscope. They immediately realized that this 

presented a potential problem to the patient and investigated further. Over the next 

2 days, staff determined they were not using a water irrigation tube with a check 

valve designed to prevent contaminated fluid from the patient from flowing back 

into the scope and irrigation water tubing. As they investigated further, the staff 

discovered the Auxiliary Water Tube (MAJ–855) had been altered with a different 

connector that was not a one-way valve. In the process of examining the procedures 

for the use and reprocessing of the colonoscope, the Murfreesboro staff discovered 

that they were not changing and reprocessing the MAJ–855 in accordance with the 

manufacturer’s instructions. 

The Murfreesboro staff reported these problems to the facility Patient Safety staff 

on December 4, 2008, and the next day, to VA’s National Center for Patient Safety 

(NCPS). NCPS conducted fact finding by evaluating the equipment and procedures 

used at Murfreesboro and by closely working with the endoscope manufacturer. 

Based on this work, a Patient Safety Alert (AL09–07) was issued to the entire VA 

system on December 22, 2008. This alert requested that all facilities determine they 

were using the correct valve and also stressed that the manufacturers’ instructions 

for all endoscopes were to be exactly followed regardless of the brand. All facilities 

were directed to determine if manufacturers’ instructions were followed in the use 

or reprocessing of flexible endoscope tubing and accessories and to report any deviations to VA Central Office by January 7, 2009. As a result of this alert, in early 

January 2009, 16 additional facilities reported they had in some way not reprocessed their endoscope water flushing systems in accordance with the manufacturers’ 

instructions. 

It must be emphasized that failure to follow a manufacturer’s instructions does 

not necessarily result in significant additional risk of cross contamination because 

the equipment is designed to have redundant safety features. With this in mind, 

NCPS contacted the manufacturer, which conducted tests to clarify what additional 

clinical risk might accrue from the failure to follow its instructions. As a result of 

these clinical and lab-based tests, the VHA Clinical Risk Assessment Advisory 

Board (CRAAB) determined there was no appreciable additional risk of cross-contamination if the only practice was incorrect reprocessing of the MAJ–855 between 

patients. This determination was made on February 6, 2009, following receipt of results of the manufacturer’s clinical tests. The CRAAB is a multidisciplinary committee that makes recommendations to the Principal Deputy Under Secretary for 

Health (PDUSH) as to clinical risk and whether large scale notifications (disclosure) 

should be made to Veterans. 

42 

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 its 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 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 VAMCs performing any 

endoscopic procedures to conduct a review of the set up and reprocessing of these 

devices. On February 9, 2009, the Under Secretary for Health instructed all medical 

centers to conduct a safety Step-Up Week from March 9 through 13, 2009, to focus 

facilities on retraining staff on the proper use of all endoscopy equipment, establishing easily tracked accountability chains for instrument cleaning, and training all 

appropriate staff about standard operating procedures. 

On February 24, 2009, Mountain Home VAMC reported that ENT endoscopes 

were not reprocessed in accordance with manufacturer’s instructions. On February 

27, 2009, after reviewing the facts with the facility and a group of experts, the 

PDUSH decided that disclosure to patients was required. The facility notified its 

local congressional delegation, local Veterans Service Organizations, and Veterans 

at potential risk. 

On March 4, 2009, in preparation for the Step-Up Week, staff at the Miami VA 

Medical Center discovered they had erroneously reported in January they were in 

compliance with the manufacturer’s instructions. Miami staff found that the water 

irrigation tubing was not correctly reprocessed and that it was not consistently 

primed and flushed prior to the start of the patient examination. While either one 

of these omissions by themselves would not have resulted in increased risk to patients, both practices together created a slightly increased potential for cross contamination between patients. The CRAAB recommended disclosure to affected Veterans, and the PDUSH agreed. 

The official policy of VHA 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. 

At 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 

43 

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 scope reprocessing that was not in strict compliance with the manufacturers’ instructions. All scopes are now reprocessed by the facility’s Supply, Processing and Distribution (SPD) program. The facility has updated policies to require 

better coordination among departments when RME is purchased and SOPs are written. All staff members responsible for handling RME are trained and certified. 

Training is noted in each competency checklist prior to actual operations. Supervisors are responsible for maintaining competency checklists and periodically validating adherence to standards. All facility SOPs are aligned with the manufacturers’ written instructions. 

At the Augusta VAMC, staff identified 1,069 Veterans who received ENT procedures between January and November 2008. VA completed an initial mailing of letters to these Veterans by February 10, 2009. Additionally, VA released public service announcements with the help of local media to further increase awareness 

among Veterans and family members. VA staff called Veterans who had not contacted the VAMC in response to the initial mailing. At the end of March 2009, VA 

sent 137 certified letters to patients who still had not made contact in response to 

the initial mailing or who could not be reached by phone. Of those letters, 128 were 

successfully delivered, one was declined, and six were returned. Of the six returned 

letters, one was identified as not deliverable because the patient was deceased. As 

of May 29, 2009, all but five of the 1,069 patients in the risk pool have received 

mail notification, and we are continuing to attempt to locate these five patients. 

Augusta VAMC also conducted a Root Cause Analysis and, based on its findings, 

took the following steps to improve medical equipment reprocessing. First, reprocessing of RME was consolidated into the SPD function. Construction also began on 

a new SPD station near the gastrointestinal endoscopy suite. A multidisciplinary 

task force ensured the ready availability of manufacturers’ instructions for reprocessing and that SOP and staff competency checklists matched those instructions, revising where needed. VA re-trained all staff involved in RME reprocessing and evaluated them using competency checklists. Finally, the facility also increased use of 

the SPD Observational Assessment Tool from once per year, as nationally required, 

to once a month to ensure continued compliance with all requirements. 

At Miami VAMC, VA identified a total of 2,609 Veterans through medical record 

searches and reviews as having been possibly at risk for cross contamination. VA 

began mailing notifications to all affected Veterans March 23, 2009. After checking 

other databases for address updates or changes, the facility sent a second certified 

mailing to Veterans whose first letters were returned as undeliverable. Miami has 

a particularly mobile population, so the facility undertook additional efforts to locate 

Veterans who could not be notified by mail. These measures included searches for 

alternate addresses on other VA databases and commercial Web sites and multiple 

visits to homeless shelters in the Miami area. The facility continues to attempt to 

locate and notify remaining potentially affected Veterans. 

44 

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. It 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 VAMCs. 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 VAMCs. 

The Safety Step-Up Week and the series of communications to the field (including 

memoranda, the patient safety alert, and reminders on national calls and at national meetings) alerted all facilities about potential problems with endoscope processing and training. Facilities have been given an opportunity during national calls 

to inform other facility leaders about what they have learned concerning the discovery of problems, patient disclosures, or best practices. 

VHA developed, published and implemented a national directive (Veterans Health 

Administration Directive 2009–004, dated February 9, 2009, ‘‘Use and Reprocessing 

of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities’’). Cornerstones of the directive are: 

• Assigning responsibilities, especially at the front line level with Network and 

Facility Directors, but also with key staff within each medical facility; 

• Requiring oversight programs be established, including unannounced site audits 

and quality assurance processes; 

• Requiring through policy that manufacturers’ instructions for the use, reprocessing, and maintenance of RME must be obtained and followed. These instructions 

must be used to develop local standard operating procedures and have them available for use by staff; and 

• Requiring staff training and assessing staff competency to ensure manufacturers’ instructions are being followed correctly. 

VA’s national SPD program has developed several training courses to increase the 

professionalism and education of field SPD employees. For example, VHA has developed a 5-day course, which includes a National SPD Certification Test, for new SPD 

staff, particularly front-line technicians. SPD Chiefs, Assistants and Supervisors can 

take a three-day seminar, and managers who supervise Chiefs of SPD can take a 

different three-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 

45 

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. 

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 develop and deploy a 

systems-based approach that will become the standard for quality management systems for SPD. In addition, a workgroup continues to investigate ways to standardize 

the brands and models of endoscopes used in a particular facility, which will simplify reprocessing protocols and training needs. The workgroup is also evaluating 

leasing options that will provide repair, maintenance and training services. VA has 

issued a request for information (RFI) for a software solution for SOP management 

that can also be used for competency verification and document control. VA expects 

such software will facilitate automatically transmitting any changes to the manufacturers’ instructions to users and verifying receipt of these changes. We are also developing a new directive that will align SPD at each medical center under the facility Chief of Staff. Standardizing organizational alignment will simplify communication lines from VA Central Office to the field and vice versa. It will also enhance 

clear lines of authority and responsibility for the SPD function. 

To better understand any possible connection between newly discovered chronic 

blood borne infections and reports of possible improper reprocessing of endoscopy 

equipment, VA has assembled a team of subject matter experts to conduct a detailed 

epidemiologic investigation, starting with an extensive review of electronic medical 

records. The review encompasses all recent and prior testing for HIV, Hepatitis B, 

and Hepatitis C, as well as other relevant laboratory test results (e.g. liver function 

tests); medical histories and risk factors for each of the three viral infections; and 

details of the actual procedures. The team will also review the sequence of patients 

receiving endoscopic exams, to assess whether a Veteran previously diagnosed with 

one of the three viruses preceded a newly-diagnosed Veteran on a daily examination 

schedule. It is very important to note that, even when completed, this study will 

not be able to demonstrate causality. However, it will be able to answer the following questions: 

• Have all positive test results for HIV, Hepatitis B and C been confirmed? Are 

there any false positives? 

• Is there evidence that any Veteran with a positive post-endoscope test was infected prior to their endoscopic procedure, but never diagnosed? 

• Can we identify whether a patient who was previously diagnosed with HIV or 

Hepatitis had an endoscope procedure the same day as a Veteran who is now newly 

diagnosed with these viruses? 

It is expected that the first phase of this investigation will take several weeks, 

to permit review of relevant charts and completion of any additional blood work. We 

will share the results with the Committee when it is available. Additional analyses 

will need to be performed after the remaining patients exposed have been tested. 

Very limited information exists in the medical literature that could elaborate or 

quantify the known risks associated with reprocessing of endoscopy equipment. One 

long-term review (1970 through 2003) examined health care associated infections reVerDate Nov 24 2008 13:27 Feb 02, 2010 Jkt 000000 PO 00000 Frm 00049 Fmt 6633 Sfmt 0190 H:\111TH HEARINGS\50926.TXT SVETS PsN: PAULIN
46 

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. 

lated 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

Quality is a journey without end. Our quality monitoring systems continue to be 

refined and, by objective measures of performance, indicate that VHA continues to 

set the pace for health care in the country. Nonetheless, the recent troubling revelations regarding endoscope reprocessing show just how hard it can be to ensure that 

care is safe and effective 100 percent of the time. We do feel, however, that these 

revelations validate our effort over the past several years to develop a culture of 

transparency in which staff are not afraid to raise issues and concerns and in which 

we share with our Veterans and other stakeholders our success and our shortcomings. This allows us to re-think and re-design our systems of care and create 

additional tools and measures to strengthen quality management. 

Mr. Chairman, quality remains a priority at VA. Our Veterans are the finest 

America has to offer and they deserve the best care possible, and because of our 

quality and safety programs, I can state VA is answering that call. Thank you again 

for the opportunity to testify. My colleagues and I are prepared to answer your questions. 

Chairman AKAKA. Thank you very much, Dr. Cross, for your testimony. 

Dr. Cross, this morning, we received a copy of the contract for 

radiation oncology services at the Philadelphia VA. It looks like VA 

paid $133,000 for about 5 months of radiation oncology services. 

Yet, nationally, such physicians make an average of $165,000 for 

an entire year’s work. My question to you is: Did VA get their money’s worth here? 

47 

Dr. CROSS. Sir, I do not know what the amount was we spent on 

that contract. The comparison that you give in regard to others, I 

think, is that they were working, I think, only part-time on some 

of these programs. 

I do not think we got our money’s worth, and I would like to reflect what some external reviewers reported to us. I have their report, sir, right here that you can request if you choose to. 

They were reviewed. Those individuals you are talking about 

were reviewed by the American College of Radiation Oncology. I 

will read you just a couple of their comments. This is an external 

reviewer looking at the quality of the program at the exactly relevant time that you are talking about. 

And they said, this process utilized to evaluate your practice consisted of in-depth appraisals of your practice, your facility, your 

equipment, policies, procedures, staff and clinical treatment methods, and they describe their review as extensive. They reported 

that the VA radiation oncology program—this is their statement, 

not mine—‘‘This VA radiation oncology department is under the 

control of the University of Pennsylvania.’’ 

They went on to say in their report that there is a very strong 

quality assurance program for the doctors and technical staff, both 

intra and interdepartmental. There is a printed summary of a 

chart-check tumor board and peer review which appears fully accurate and, according to the onsite physician reviewer, it is ‘‘the best 

I have seen on any site visit.’’ 

He says, continuing medical education was available to the physicians and staff, and it appeared that they met or exceeded the 

State licensure requirements. 

Here is the summary conclusion from this report: ‘‘In summary, 

your PVAMC practice, as noted above, is well organized; an operated radiation oncology practice that not only meets but in many 

aspects exceeds the ACRO standards for practice accreditation. The 

ACRO is pleased to inform you that the PVAMC has been awarded 

full 3-year accreditation.’’ 

Chairman AKAKA. Thank you, Dr. Cross, for the answer you gave 

me before you read that letter. 

Dr. Cross, we have heard many proclamations about how VA 

care is the best anywhere. How can VA’s care be the best anywhere 

in light of the problems we heard about today? 

Dr. CROSS. Sir, I appreciate your asking that question. 

Our best care anywhere I think is true, and it is in regard to the 

overall organization. 

The problem I am facing, the problem I am working with and 

that I am challenged to change is consistency. It is not enough that 

we are better. I take no glory in that. I take no pride in that. That 

is, as long as any patient is being hurt anywhere because there is 

a deficiency or variation, I cannot be satisfied. 

So the issue here is consistency throughout this large system. I 

have 1,400 plus sites of care. I have to make sure that every single 

one of them is performing up to standard on these very complicated 

procedures, and these are complicated procedures with many, many 

steps. 

We wrote that there are directions from the manufacturer. Well, 

it turns out that every single scope has a direction. It turns out 

48 

that every different manufacturer has directions. It turns out that 

different scopes have different directions. Then they change them 

periodically as they upgrade their thinking about it. Furthermore, 

other organizations put out guidance, and they all vary one from 

the other. 

We have said we cannot deal with that. We are a large organization. We have to have consistency. You must go by the current directions from the manufacturer. That is the only standard that we 

will follow. We will ignore the other ones because we have to focus 

on that. 

And these slides that we have given you, sir, reflect the broad 

overview of VA quality; and even our patients fare better in terms 

of mortality within our system than in other systems. But that is 

not enough for me. That is not enough for you, I believe, sir. While 

there is any problem left, we have to deal with that variation. 

Chairman AKAKA. Thank you very much. 

Let me call on Senator Burr for his questions. 

Senator BURR. Thank you, Mr. Chairman. 

Dr. Cross, welcome. And to all that are here, I meant what I said 

earlier. I hold you in high esteem for the jobs that you do. 

Oversight, I hope you understand, is a very important role of this 

Committee, and I think it is impossible to fully understand the 

depth of a problem until you have had an opportunity to air it. Our 

role is to take bits and pieces that are out there and try to construct a picture out of it. It is not pleasant. I would rather not 

spend the time on it, but I think we all agree that the patient population that is served demands that we do this. 

Let me ask you, Dr. Cross, how many hospitals in the system 

today are compliant with the VA plan for sterilization from infection of reprocessing equipment? 

Dr. CROSS. Sir, like you, I was very disappointed in the report 

from the IG on their documentation issue—looking at the documentation of the SOPs and the training documents had to be in 

place. In fact, I mandated that each of the VISN directors report 

to me within days that every single one of those SOPs were in 

place and that every single one of those training documents were 

in place, and that if I walked into one of those places this morning 

I could be absolutely assured that I would find them. They certified 

that to me in writing about 2 weeks ago. 

Senator BURR. You read an independent review of the Pennsylvania facility on the brachy treatment. If an independent facility 

went and assessed all of the facilities relative to reprocessing devices, would the report be as glowing today? 

Dr. CROSS. You have hit right on the issue. None of those external agencies found the problem. None of the oversight organizations, of which we have many, found any of these issues with endoscopy reprocessing or with the brachytherapy program. We reported those. We found them internally. 

That is why it is so important—this is the critical point—that we 

have external oversight and that we have internal reporting. My 

staff have to believe that they should do the right thing. If they see 

something wrong, they have got to come report it. 

49 

And I have got to be very careful about discouraging that by saying that I am going to shoot the messenger. I do not want to do 

that. If anything, I would like to reward the messenger. 

But then I have to balance that with the external reporting, like 

with the IG, that we have a very collaborative relationship with. 

After they told me that they made the correction, the IG sent people out to look and make sure that it was done. If they were not, 

then that becomes for me an accountability issue. 

And we are now taking disciplinary action at multiple sites 

across the country, reluctantly, not so much for the people who reported the problems—not at all—but for the people that I held accountable to institute the corrections. And so, those issues largely 

related to supervisors. They include demotions. They include, in 

some cases, changes of jobs, changes of organization, and I think 

one person resigned. 

Senator BURR. In the National Center for Patient Safety review 

of the situation dated 17 April and included in the IG’s report, the 

VA stated the following: ‘‘The analog for endoscopy reliability 

would be commercial or military aviation maintenance.’’ 

I am going to be real direct on this one. Keeping in mind that 

that is your statement and not mine, if a surprise inspection was 

done on an airline and it was found that the airline was compliant 

with both procedures and documentation 43 percent of the time, 

would you fly on it or would you have your family fly on it? 

Dr. CROSS. Well, fortunately, documentation and the actual care 

of the patient are not necessarily the same thing, but I feel no satisfaction in that. I was distraught by that report. I found it unacceptable, and that is why I mandated that my VISN directors immediately confirm to me that, in fact, the paperwork that the reviewers were looking for was in place. 

I agree with you. I would have been very concerned. 

Senator BURR. I requested and received a list of dates when endoscopy procedures were performed for those veterans who tested 

positive. I am not an epidemiologist, I admit that, but I would 

gather that if multiple veterans who tested positive had this procedure performed at the same hospital on the same day, then there 

is a fairly good chance that the VA caused at least one of those infections. 

The data I received back from Augusta shows that five of the 

seven infected patients had this procedure performed on the same 

day as another infected veteran—on April 16, June 10, August 20, 

September 10; two infected patients had this ENT procedure performed on the same day. 

What is the VA’s opinion of these facts? 

Dr. CROSS. Here is what we have done. We have asked the epidemiology team—these are scientists that deal with investigation in 

terms of how infection occurs, where it spreads and so forth—that 

they look at this and do a detailed analysis, including genetic testing of the viruses to see if there is any link at all. They are in the 

process of doing this at this time. However, sir, I do have a statement I can read to you at this moment. 

Senator BURR. OK. 

Dr. CROSS. Coming from my epidemiology team in regard to the 

numbers of cases, understanding that this is preliminary, that they 

50 

are still working on this, that they do not have a final report at 

this time and that we are not ready to draw any final conclusions 

at this time. This is just where they are at the moment. 

It should be noted they say that the number of veterans who 

have been newly diagnosed with HIV, HBV or HCV as a result or 

in association with endoscopy look-back analysis is consistent with 

or less than the number of infected veterans that we would expect 

to find based on previously published SERO prevalence studies. Although not definitive proof, this suggests that these infections are 

not associated with the endoscopy procedures. 

VA is in the process of conducting an epidemiological look-back 

study of those veterans and others who underwent endoscopy procedures at those sites to better characterize the possible risk transmission of these infections in these procedures. 

That is interesting as a matter of science. But when those patients come in and we find that they are positive, I am not worried 

about what the cause was. I do not question them about the cause. 

That is not my issue. I just want to take care of them at that 

point—first and foremost, take care of the patient. 

This evaluation that we are doing is all in the background. It is 

not to question them. It is not to lay any blame. It is not to redirect 

where the responsibility might lie. Our first priority is to take care 

of the patient. This is a scientific investigation that we will publish 

over time. 

Senator BURR. I can go to your charts because you should be 

proud of the lack of MRSA infections within the system. 

Dr. CROSS. MRSA is a scary infection. 

Senator BURR. Yes, you highlight it. And there is nobody today 

that can tell us we have not done everything to prevent it. We 

sterilize equipment. We sterilize operating rooms. Yet, somehow, 

this bug lives somewhere. 

You highlight the fact that we do a better job than everybody 

else. So, I listen to that last response from your epidemiologist and 

I ask, well, where does that get us? 

I mean I think we all know that there is—I am going to use Dr. 

Nolan—there is a structural problem. You cannot assure me that 

everybody is doing it exactly like your dictates ask. I think we all 

agree with that. We all agree that it should be—that noncompliance is unacceptable. 

I will only say this, I hope that you will publicly or privately 

share with us when those epidemiologists come back after they 

have looked at the genomic connection, so that we can know, once 

and for all, if there was a direct link. Clearly, when you look at it 

on the surface, same day, same place. 

Dr. CROSS. Different scopes. 

Senator BURR. Same process followed within the hospitals. 

Dr. CROSS. Sir, I concur, and I have already pledged that when 

we produce this report it is my intention to publish it. 

Senator BURR. My last question, Mr. Chairman. You have been 

very kind to me today. Dr. Cross, 297 veterans are currently being 

tested for possible exposure to Hepatitis B, C and HIV at Mountain 

Home, Tennessee, VA Medical Center. In my capacity as Ranking 

Member of the Committee and as a Senator from North Carolina 

who represents 7,500 veterans in a 3-county area that are serviced 

51 

by Mountain Home, I was not told, my staff was not told, that you 

are contacting 297 veterans about the possibility of infection. 

I assume that some of them may be from North Carolina. I have 

sort of got two skins in the game: as Ranking Member of the Committee actively involved in this investigation through this oversight 

process; as a Senator from North Carolina concerned about the veterans that live there, given the fact that this occurred after the 

Murfreesboro and Augusta disclosures. 

Why was this not treated at the same level as the other issues 

with public disclosure, at least congressional notification? 

Dr. CROSS. Sir, let me be very clear that I apologize to you for 

lack of notification to your office. The notifications were done by 

the local facility to the congressional delegation in Tennessee. 

There was also a communication with the Committee. Also, we put 

it on the internet to some degree. We talked to the patients and 

did disclosure to the patients. In fact, I have a copy of the internet 

site here if you want it. 

Fortunately, no positives, small-scale and one of the errors that 

they made at Mountain Home is a different character from all the 

others. The type of antiseptic they were using, it was not that it 

was too weak; it was too strong. They were not diluting it enough, 

and so the actual concentration of antiseptic—one of the errors that 

they were making—was several times too high. 

Senator BURR. Well, let me end with this because my staff had 

posed the question and the answer that they got was that it did 

not involve a large enough group of veterans. 

Dr. CROSS. But we did notification, and we did call the local delegation. We were in error in not notifying you as well. 

Senator BURR. What is the size it has to get to before it is at a 

level of importance? 

Dr. CROSS. Well, at the moment, we are at zero positives. 

Senator BURR. No. What is the size of the potential pool before 

this raises to the threshold of being concerned? 

I mean 297. I am going by VA’s statement, and I apologize, but 

that is all I can do: ‘‘The decision not to include Mountain Home 

results on the national Web site was that it did not involve a large 

number of veterans. The local delegation was notified and veteran 

disclosure has begun.’’ 

What is the threshold? If 297 does not meet it, then what is the 

number? 

Dr. CROSS. Sir, I will define that according to however you would 

like me to define it. If it is one, we will do that. 

Senator BURR. I hope that the concern at the VA is one. I am 

not sure that an IG investigation, I am not sure that a public disclosure, and I am not sure that a Web site notification is required 

at that number. 

But I would just say, as the Ranking Member of the Committee, 

I think 297 is a big number. I think that suggests that there is 

something extremely serious to look at, whether there is fire behind the curtain. I am glad to hear that we are finding out there 

is not, but I think that that number as a threshold is significant. 

I just have a problem with the answer that we were given, which 

was it did not meet the threshold of a large group of veterans. 

52 

Dr. CROSS. Sir, the only answer I have for you is I apologize, and 

it was an error to not inform you. 

Senator BURR. I thank you. 

I thank the Chair. 

Chairman AKAKA. Thank you very much, Senator Burr. 

Just to let Senator Tester know, we still are in the first round. 

Senator Tester. 

Senator TESTER. Thank you, Mr. Chairman. I will try to make 

this as quick as I can. 

Dr. Cross, sorry I missed your testimony, but I want to go back 

to a previous comment that Dr. Daigh made to get your opinion on 

it. He talked about the VISNs’ lack of ability to influence individual 

hospitals’ quality of care. He has taken a look from a different perspective than somebody inside the organization. Do you think that 

this is correct? 

Do you think that it can be improved upon and how are you 

going to do it? Or, is it not their job? Does it need to come from 

somewhere else? 

Dr. CROSS. Let me say that it is their job, and I think that has 

been an area where we need improvement. 

Let me tell you how. Let me talk to you for a moment, sir, if I 

may, about how this works. I have some of the best experts in the 

world on my staff to help me figure how these things should be 

done—safety, quality, so forth—and we put out very good instructions and directives. That is fine. That is a piece of paper. And then 

we have meetings and so forth to discuss that. 

Execution then becomes of paramount importance. A key link in 

the execution chain is the VISN who are the intermediate commanders, so to speak. While their focus may be on the interaction, 

budget, all of those kinds of administrative things, quality of care 

also has to be acknowledged and a part of their responsibility at 

all levels. Many of them do a wonderful job on this. I think that 

we need to enhance the work and the role that they play, particularly in quality of care. 

Senator TESTER. What role does peer review play in quality of 

care? 

Dr. CROSS. Peer review has a long and famous history. It is not 

highly regarded in some organizations. 

I highly regard it. We track it. We classify the numbers. We look 

at each facility in terms of how many peer review reports, reviews 

that they are doing and what grade they gave those reports. If they 

are not doing very many or if they are grading them in a way that 

we think is too generous, we call them up and talk to them about 

it. 

Senator TESTER. How do you guard against retribution from a 

negative peer review analysis? 

Dr. CROSS. In our system, the individual always has the right to 

appeal, and they can ask for a further review. 

Senator TESTER. All right, but I am talking about the other direction. Let’s say that I see something going on as a peer that is not 

up to snuff. I report it, and I am dressed down for it. How do you 

guard against that? 

Dr. CROSS. Let me ask my colleagues who might give you more. 

53 

Senator TESTER. That would be fine. If you want to defer it, you 

can. 

Dr. CROSS. Juan or Bill? 

Mr. MORALES. Sure. I am the Director at Tennessee Valley which 

is Nashville to Murfreesboro. 

Senator TESTER. Yes. 

Mr. MORALES. Part of the peer review process is that if let’s say 

there is another provider that reports—is that your question? 

Senator TESTER. No. My question is that for a peer review process to work, the person who is being the bad guy—who is doing the 

work that nobody wants to do, pointing out an inadequacy in the 

system—needs to be guarded against so that retribution does not 

take place. How do you stop or guard against retribution toward 

somebody who is giving an honest analysis on somebody who is 

inept? 

Mr. MORALES. Well, that is where my responsibility comes in: to 

make sure that whatever is being reported by the person, that we 

are protecting that person, that we are taking the right steps. 

Senator TESTER. Are they being adequately protected now? 

Mr. MORALES. I can tell you from Tennessee Valley, what we 

have in the organization and what we follow, the VHA policy, yes. 

Senator TESTER. OK. Yes, go ahead, Dr. Duncan. 

Dr. DUNCAN. I think the key element is building a culture of 

quality and safety and building a culture that we are a learning 

organization. 

Senator TESTER. That is right. 

Dr. DUNCAN. I think you can look at peer review as a punitive 

mechanism. I think we try to approach it from a viewpoint that is 

a learning mechanism. I think that we do monitor how many of our 

peer reviews fall into where there are questions raised about the 

care, and so we do that, and we do see that people are utilizing 

peer review to point out errors and point out areas we can improve. 

Senator TESTER. OK. I appreciate those answers. Let’s go back 

to Dr. Cross. 

Dr. Cross, you said that you valued peer review. I know oftentimes people at the top have certain goals in mind that do not filter 

through the system. Maybe VISN is part of it. Maybe there are 

other parts. I mean is it valued throughout the system to the extent you would like to see it valued? 

Dr. CROSS. Probably not, but here is what I have done to correct 

that. I worry about the internal aspects of peer review, the people 

who are reporting on their colleagues and that they may not want 

to do that. 

Senator TESTER. Yes, that is right. 

Dr. CROSS. It is alluding to what you were talking about before. 

So I decided we should do this externally as well. So we now ordered a grant which the acquisition folks are still working on, nationwide, to give us an external arm of peer review nationwide, and 

so that someone completely unrelated comes in and does this same 

process and gives us another level of evidence. 

Senator TESTER. OK. So you are doing an investigation right 

now. 

And, excuse me, Mr. Chairman. I know my time has run over. 

I have this next question to ask. 

54 

You are doing an investigation right now on Hepatitis and HIV 

linked to the procedures of the unclean equipment. That is correct. 

Who is doing your peer review? 

Dr. CROSS. On the epidemiology? 

Senator TESTER. Yes, on your investigation? 

Dr. CROSS. We are going to publish it in the peer review journal 

if they will accept it. 

Senator TESTER. OK. If there is another round, I will wait. If not, 

I can keep going. 

Chairman AKAKA. We will have another round. 

Senator TESTER. OK. 

Chairman AKAKA. Thank you. Thank you, Senator Tester. 

Dr. Cross, this is a follow-up to questions that have been asked 

on endoscopes. Your testimony that says VA’s quality of care is 

good and that your quality management works. How, then, do you 

reconcile your testimony with the IG’s report that only half—half— 

of the VA’s facilities complied with the internal policy for endoscopes even after you told them to fully comply as part of the stepup? 

The question is, what is the disconnect? Are your network directors listening to you? 

Dr. CROSS. I guarantee you they are going to listen, and they 

know how I feel about this report. We had some very heart-to-heart 

discussions. I was very disappointed in that report, and, further, 

we are holding folks accountable. 

Now, again, I want to make the important distinction that folks 

who come forward and report things and say they are wrong, I 

would like to pat them on the back and say, thank you for doing 

a good job. 

But when we have identified something is wrong, I expect it to 

be corrected; and we have talked about it several times. It has got 

to be done, and that becomes an issue of accountability at that 

point. 

Chairman AKAKA. Well, thank you, Dr. Cross. 

Last year, we had problems with privileging of physicians to perform procedures they were not qualified to do at the Marion VA. 

Now the person is reporting that the doctor in Philadelphia responsible for the problems with the prostate procedures was allowed to 

do those procedures at VA but not at the University of Pennsylvania. The bottom line, did the Philadelphia VA have proof that 

the physician could perform this procedure competently before they 

let him do it? 

Dr. CROSS. I have not looked into that specific allegation as of 

yet. 

There is an important distinction here that I would like to point 

out to you about something that you raised earlier. You mentioned 

the contract and how much it cost. The contract was not with the 

individuals. The contract was with the university, the health care 

system, to provide the appropriate people to do that care, but that 

does not in any way minimize, escape or excuse our oversight of 

that process. I want to be very, very clear. If it is in our facility, 

it is our responsibility. 

And so, sir, I will look into that allegation. 

55 

Chairman AKAKA. Well, thank you so much for pointing that out 

as one would assume the university would send a qualified person. 

Dr. Cross, the IG’s reports describe significant problems in VA’s 

quality management and patient safety efforts, and you have 

shared with us what you will do to address those concerns. But a 

fundamental question arises. Do you have confidence that VA’s 

Central Office has a handle on the quality of care being provided 

in the field? 

Dr. CROSS. Senator Burr asked a question a while ago: why did 

we change the reporting relationship? I have been looking for an 

opportunity to answer that, and this relates to it very well, as you 

just opened up that discussion. 

Quality is so fundamentally important that the previous Under 

Secretary for Health reorganized it. He felt that patient safety, 

quality and the Quality Office should not be managed independently. He found that they should interact very closely; that they 

should be working together. They should be within the same organization. So, he merged those into the same organization. The head 

of that organization does report to me, the Under Secretary of 

Health, directly. 

I would like to have Dr. Duncan comment on that, sir, to provide 

further response to your question. 

Chairman AKAKA. Thank you. 

Dr. Duncan? 

Dr. DUNCAN. Thank you for the opportunity to respond. 

I cannot speak for Dr. Kussman, but in my conversations with 

him, what Dr. Cross said is absolutely correct. The IOM report, 

when it was looking at quality health care systems, defined—and 

Dr. Nolan gave those to you at his opening statement—the whole 

universe of what a health care system should be. It is that quality 

includes patient safety and that our patient safety organization is 

in Ann Arbor, Michigan. 

It is true that they reported directly to the Under Secretary before. By reporting to me, I am in Washington every morning. I sit 

in on the Under Secretary and the senior leadership of the VA. I 

sit in with them, and they hear about quality and safety every day. 

I am in the Under Secretary’s office. I can walk into his office anytime with any issue. So it was, I think, Dr. Kussman’s desire to elevate the place of quality and safety, to coordinate it across our 

whole system. 

And the second point I want to make is that quality and safety 

does not reside just in my office or in the National Center for Patient Safety. It is the responsibility of every program office. It is 

the responsibility of every facility director and every member of our 

VA family to ensure that we have quality and safety. And so, coordinating that is a huge job, and this is the reason they set up 

my office. 

Chairman AKAKA. Thank you. Thank you very much. 

Let me call on Senator Tester for the second round. 

Senator TESTER. Yes, thank you. Thank you, Mr. Chairman. 

OK, Dr. Duncan, quality and safety is your job. I do not doubt 

it just by the tone of your voice and your resoluteness to that. 

We are dealing with a number of individuals here. Compared to 

the private sector, it may be lower than the standard of screw ups, 

56 

but it may be equal to or higher. For the purpose of this hearing 

and for the purpose of my perspective, I think I agree with Senator 

Burr. One is too many, so we have to go for zero tolerance. 

What are you doing to make sure it gets to the ground, if you 

know what I mean? We can have all these visits in Senate Committees, and we can have visits in Dr. Cross’s office and your office, 

but the fact is where it happens is in the hospital, on the ground 

with the patients. What is being done to get it there? 

Dr. DUNCAN. I think that is a very central question, and right 

now my office is actually right in the center of the operations. So 

I have access to the people that oversee the VISNs and the operational element. 

Senator TESTER. So, we will just back up for a minute. I do not 

mean to cut you off. So what are you doing with the VISNs since 

they are inadequate by several different people’s perspective? What 

are you doing with those VISNs, just for an example, to get them 

fired up, get them off their duff and get them going in the right 

direction; do what they need to do to make sure things happen? 

Dr. DUNCAN. We are trying to coordinate. We do this with many 

mechanisms where we bring together the various elements in VHA 

that are responsible and have quality and safety programs. We coordinate those at the Under Secretary’s Coordinating Committee 

for Quality and Safety. 

A big player in this is the Operations. The Operations has the 

responsibility for doing quality improvement. My office is doing the 

coordination. We do the measurement and analysis, and then we 

work with them to execute the quality improvement. 

They have developed a very robust systems redesign. You heard 

Dr. Nolan talking about designing a system. Well, in Dr. Cross’s 

testimony, you can see the many systems that have been put in 

place to do the quality improvement. So this is a journey that we 

are on. 

Dr. CROSS. Can I add just a word to that? 

Senator TESTER. Yes, you can. 

Dr. CROSS. A concrete example, in this last go-round when you 

heard me say I made them certify that those SOPs and training 

documents were in place, I did something else too. By the 14th of 

July, their staff are to have visited every single facility unannounced—unannounced by the 14th of July. 

Senator TESTER. What are they looking for? 

Dr. CROSS. The reprocessing, training, and documentation issues. 

Senator TESTER. Do you have the results of those visits? 

Dr. CROSS. By the 14th of July. 

Senator TESTER. Oh, July, OK. I am a month ahead of myself. 

OK. I would love to see what the results of those visits are. If that 

is public information, I would love to get it from you. 

And the reason is this: I am a farmer, which is fairly well-known 

around here. You can grease the tractor until the cows come home, 

but if you don’t get on it and get some work done, nothing ever 

happens. 

And so, we need to make sure that the information that I believe 

is in your guys’ heads—I really believe it. I believe that you are 

sincere about it, and I believe that you want to see it happen. 

57 

Something is happening—a disconnect here. It is not getting to the 

ground where the work is being done. 

I do not know how to do it. I have my own ideas, but you guys 

are in the business, and I am sure there are better ideas than I 

have. 

Just a couple more things, Dr. Cross. Has there been any evaluation or follow-up as far as the prostate issue and how many were 

affected; if any have died? 

Dr. CROSS. When we found the issue in Philadelphia, which we 

found, I decided and the Under Secretary at the time decided that 

we should do this the way we normally do things. We should not 

just assume that the issue was limited to one facility. So I mandated a review of all the facilities that do those procedures. 

We did find some deficiencies. I have curtailed some programs. 

Senator TESTER. What about its impacts on vets? 

Dr. CROSS. I am not aware of adverse impact. I know about the 

case that was reported in the newspaper. But, in terms of, you 

said, mortality? 

Senator TESTER. Yes. 

Dr. CROSS. I am not aware of any such issue. 

Senator TESTER. I just want to close real quick, if I might, Mr. 

Chairman. 

I spend more time on this Committee than any other committee 

I have, and I have some really important committees. I go around 

the State of Montana. I visit with vets all over the place. I have 

110,000 of them in the State of Montana. They all, for the most 

part, speak very, very highly of the VA. Because of that, I speak 

very, very highly of the VA because the service they offer is really 

the proof in the pudding. 

Where I am getting at on this is that I know that there are allowances made for things not happening and certain people getting 

sick because of screw ups. I am very proud of the VA. I think they 

do a great job. I am not proud of them on this one, and I think 

that it needs to be fixed. 

And, if the results come back that the private sector is worse 

than the VA, do not even look at that. That is too low of a bar. 

That is like me comparing things here to the private sector. We do 

not want to do that. We want to set our bar at a standard because, 

quite frankly, this is a good outfit, and I do not like to see it get 

black eyes. And I will do everything I can do to help you fix it, but 

in the end it has to be fixed. 

I was just given a timeline of how things have happened here. 

I know hindsight is 20–20, but if you look at that timeline it is totally ridiculous that it came to this point. This should have been 

fixed a long time ago. I do not think it slipped through the cracks. 

And I know you are not Superman, but we expect you to be. 

Thank you very much. 

Chairman AKAKA. Thank you very much, Senator Tester. 

I have a question for the medical center directors from Murfreesboro, Miami, and Augusta, and really it comes down to two questions. One is, because we have been talking about this, how do you 

go about creating an environment in which employees feel comfortable bringing problems to the attention of leadership? That is 

one. 

58 

And the other is, can you describe for us the extent to which networks and Central Office provide you with oversight on your quality management work? 

So let me, in that order, call on Mr. Morales first, then Ms. 

Berrocal and Ms. Wiley. Mr. Morales? 

Mr. MORALES. Thank you for the question, Senator Akaka. 

The environment or the culture of safety—in that employees can 

come forward and report things—it starts in my office setting the 

example that when things are reported we listen to the employees, 

we follow through, and we fix it. If the employee feels that they are 

going to come forward and nothing is done by the leader of the organization, then they know that they are wasting their time. 

So it starts within my office, making sure that when things are 

reported we look into it. We report it immediately to the people 

that need to hear it, and we take care. The first question that we 

ask is was there any harm to our patients? That is how the culture 

in the organization starts. 

I think the other thing is how important it is to have our patient 

safety officers being part of any discussion that has to do with patient activity because they bring a very different perspective. They 

look at things and can help with making sure that the environments are safer for our patients. So that is number 1. 

Number 2, the support that we get. I can say from my perspective, that since I have been a director at Tennessee Valley—I came 

in at VISN 9—I have gotten tremendous support in looking at our 

quality management issues and how we are structured. We had our 

CAP review about a year ago, and they identified some areas that 

we needed to improve in our program. We took action. We work 

very closely with our network office, and also we follow through 

when there are things that come from either the VISN or from 

Central Office and things that we need to look at and that we need 

to pay attention to. 

Chairman AKAKA. Thank you very much. 

And, Ms. Berrocal? 

Ms. BERROCAL. Thank you, Senator Akaka. 

At our medical center, we believe that the patient safety issue is 

the responsibility of everyone in the medical center, and we encourage a culture that would allow people to come forward. 

Similar to Mr. Morales, what we do is we ensure that when people bring issues to our attention—whether that be a Congressman’s 

office or an employee, a patient, whomever—we are listening and 

we take steps to ensure that they know we are taking some kind 

of an action on it. In that same manner, we assign administrative 

investigation boards where we think there might be issues that require more in-depth analysis, and we take appropriate action if 

there is something that is not a system issue, but negligence on 

someone’s part or a misconduct issue. 

I work very carefully with the whole leadership team to ensure 

that our decisions are patient-centered, so that if we are always focused on the patient, what is proper and correct for the patient, 

that that is how we should make our decisions, and that is how we 

should always question things. 

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I also indicate to them that we need to create a culture where 

it is not just business as usual, but every single thing we do is important and critical because we take care of patients’ lives. 

I have the patient safety officer reporting directly to me. And 

what we are doing now with patient alerts and that kind of thing 

is: we have them come every Monday. She comes to us and reports 

to the whole leadership team in terms of any patient alerts and 

who they went to for response, how we are validating those responses. We ensure that she then keeps the evidence of how we 

validated that, so that I can make sure we are continuing to create 

a culture of consciousness about patient safety. 

At the network level, we receive a lot of support. We have a Joint 

Commission Readiness Program at the network level. There is a 

Patient Safety Program. There is the Quality Management Office 

that provides support for us. We have the VISN Performance Improvement Teams that come by the medical centers and check to 

see whether we are doing things properly or not. We, obviously, 

have the other external reviews that we have to respond to in 

terms of our accountability to the network and Central Office in 

terms of the IG CAP and the SOARS visits, and those kinds of 

things. 

Chairman AKAKA. Thank you. Thank you very much. 

Now we will hear from Ms. Wiley. 

Ms. WILEY. Thank you, sir. 

In Augusta, we believe that safety has to be embedded in everything that we do. It is the underpinning of quality, and we incorporate that. I walk around, as does my leadership team, and as we 

are making rounds on our units, talking to our providers, we talk 

about safety. 

We also incorporate safety as a part of agenda items for all of 

our committees, even at the basic levels of the organization. We include staff in a lot of our safety reviews, our RCAs—which are our 

Root Cause Analysis—of systems issues. We have staff that are involved in that. I sit in on all those reviews as they are summarized, 

so that we can look at safety and other systems issues that might 

need improvement. 

How the VISN supports us in Georgia: monthly, our VISN director and other members of his staff, including the quality management officer, come to our medical center where we walk around 

and look. We talk. We meet with staff about all the pertinent 

issues that may be involved in our performance improvement activities. 

We have a quarterly meeting that encompasses all of the quality 

management and performance improvement activities for all of the 

eight medical centers in our VISN, so that we are not only talking 

about quality at one site. We are looking at it systematically in our 

VISN. 

Chairman AKAKA. Well, thank you very much for your responses. 

We really appreciate your being here. 

In closing, we have heard of problems today in VA health care 

that are very disturbing. It is not enough that VA outperforms private hospitals in many ways. The Nation’s veterans deserve more, 

and the Committee will continue to insist that VA provide the best 

care anywhere. 

60 

I look forward to working with the new administration, and in 

a way it is good to say, ‘‘the new administration’’ because it is like 

a commencement for a new system and a better system with better 

quality. We know some of the problems and look forward to working with you to correct that in the case where it needs to be corrected and to improve our system. But the sense here is that you 

all are poised to move ahead here with this administration and try 

to improve the system to deal with and service our veterans, which 

is what this is all about. 

So thank you very much. I am looking forward again to working 

with you and the new administration to find solutions to the overarching problem of who is managing VA quality. I think we need 

to consistently look at this and continue to try to improve the system and maybe work up a new design, but we need to change it. 

As I like to say to our old-timers, we cannot continue with a 

World War II system. We have to change that system and move it 

to these current times. This is what we are all about, and, together, 

we can bring these changes about. 

So thank you very much. 

The hearing is adjourned. 

[Whereupon, at approximately 12:27 p.m., the hearing was adjourned.] 

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