VHA'S RISK MANAGEMENT POllCY AND 

PERFORMANCE 

HEARING 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

OF THE 

COMMITTEE ON VETERANS' AFFAIRS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTH CONGRESS 

FIRST SESSION 

OCTOBER 8, 1997 

Printed for the use of the Committee on Veterans' Affairs 

46-316 CC 

Serial No. 105-23 

U.S. GOVERNMENT PRINTING OFFICE 

WASHINGTON: 1998 

For sale by the U.S. Government Printing Office 

Superintendent of Documents. Congressional Sales Office, Washington, DC 20402 

ISBN 0-16-056429-8 
COMMITTEE ON VETERANS' AFFAIRS 

BOB STUMP, Arizona, Chairman 

CHRISTOPHER H. SMITH, New Jersey LANE EVANS, Illinois 

MICHAEL BILIRAKIS, Florida JOSEPH P. KENNEDY II, Massachusetts 

FLOYD SPENCE, South Carolina BOB FILNER, California 

TERRY EVERE'IT, Alabama LUIS V. GUTIERREZ, Illinois 

STEVE BUYER, Indiana JAMES E. CLYBURN, South Carolina 

JACK QUINN, New York CORRINE BROWN, Florida 

SPENCER BACHUS, Alabama MICHAEL F. DOYLE, Pennsylvania 

CLIFF STEARNS, Florida FRANK MASCARA, Pennsylvania 

DAN SCHAEFER, Colorado COLLIN C. PETERSON, Minnesota 

JERRY MORAN, Kansas JULIA CARSON, Indiana 

JOHN COOKSEY, Louisiana SILVESTRE REYES, Texas 

ASA HUTCHINSON, Arkansas VIC SNYDER, Arkansas 

J.D. HAYWORTH, Arizona CIRO D. RODRIGUEZ, Texas 

HELEN CHENOWETH, Idaho 

RAY LAHOOD, ILLINOIS 

BILL REDMOND, New Mexico 

CARL D. COMMENATOR, Chief Counsel and Staff Director 

SUBCOMMITTEE ON HEALTH 

CLIFF STEARNS, Florida, Chairman 

CHRISTOPHER H. SMITH, New Jersey LUIS V. GUTIERREZ, Illinois 

MICHAEL BILIRAKIS, Florida JOSEPH P. KENNEDY II, Massachusetts 

SPENCER BACHUS, Alabama CORRINE BROWN, Florida 

JERRY MORAN, Kansas MICHAEL F. DOYLE, Pennsylvania 

JOHN COOKSEY, Louisiana COLLIN C. PETERSON, Minnesota 

ASA HUTCHINSON, Arkansas JULIA CARSON, Indiana 

HELEN CHENOWETH, Idaho 

(II) 
CONTENTS 

Page 

OPENING STATEMENTS 

Chairman Stearns ........ .... ...... .... ..... ...... ...................... ....... .... .... ....... .......... .... ........ 1 

Hon. Luis V. Gutierrez ............................................................................................ 2 

Prepared statement of Congressman Gutierrez .... ........... .... ........ ..... .... ......... 55 

Hon. Michael Bilirakis .............................................. .............................................. 3 

Prepared statement of Congressman Bilirakis .............................................. 61 

Hon. Lane Evans, Democratic Ranking Member, Committee on Veterans' 

Affairs .................................................................................................................... 4 

Prepared statement of Congressman Evans ......... .... ... .... .... ............. ............. 63 

Hon. Jerry Moran .................................................................................................... 5 

Hon. John Cooksey .................................................................................................. 30 

Hon. Joseph P. Kennedy, II .................................................................................... 32 

Prepared statement of Congressman Kennedy..... .... .... .... ... ...... ............ ........ 58 

Hon. Asa Hutchinson .. ...... ........... .... .... ... ........ ....... ...... ....... ... ..... .... ..... ............ ........ 15 

WITNESSES 

Doherty, T.C., Director, Miami VA Medical Center, accompanied by Douglas 

Bradshaw, Assistant General Counsel, Department of Veterans Affairs ........ 37 

Prepared statement of Mr. Doherty ................................................................ 141 

Headley, Elwood, M.D., Director, Boston VA Medical Center .. .... .......... ............. 35 

Prepared statement of Dr. Headley ................................................................ 135 

Kizer, Kenneth W., M.D., M.P.H., Under Secretary for Health, Department 

of Veterans Affairs accompanied by Nancy Wilson, M.D., M.P.H., Director, 

Office of Performance and Quality, Department of Veterans Affairs; James 

McManus, M.D., Medical Inspector, Office of Medical Inspector, Department 

of Veterans Affairs ............................................................................................... 21 

Prepared statement of Dr. Kizer ..................................................................... 107 

Leape, Lucian, M.D., Harvard School of Public Health ....................................... 5 

Prepared statement of Dr. Leape .................................................................... 93 

Mather, John, M.D., Assistant Inspector General for Health Care Inspections, 

Office of the Inspector General, Department of Veterans Affairs .................... 23 

Prepared statement of Dr. Mather .................................................................. 117 

Valentine, Billy, Director, Muskogee VA Medical Center, Department of Vet- erans Affairs ..... ......... ........ ........... ..................... .................... ....................... ........ 39 

Prepared statement of Mr. Valentine ............................................................. 148 

MATERIAL SUBMITTED FOR THE RECORD 

Articles: 

"Deaths rise at VA hospitals," Times Herald-Record, (Middletown, NY) 

May 13, 1997 ...... ..................... ................. ......... ........... ............. ...... .............. 72 

''VA hospital deaths soar," The Reporter Dispatch, May 15, 1997 ............... 73 

"Families describe deaths," Times Herald-Record, May 15, 1997 ........ ........ 75 

''Vet fades. A casualty of 'chaos'," Times Herald-Record, May 13,1997...... 78 

"Castle Point deaths under investigation,"Poughkeepsie Journal, May 21, 

1997 ................................................................................................................ 80 

''Veterans' suffering is more than numbers," Times Herald-Record, May 

21, 1997 .......................................................................................................... 81 

"Families tell of VA neglect," Times Herald-Record, May 26, 1997 .... ........ 82 

"Dead in 38 days," Times Herald-Record July 1, 1997 ................................. 84 

"Deaths blamed on VA cutbacks," Times Herald-Record, August 6, 1997.. 87 

(III) 
Page 

IV 

"Tales of neglect rise at VA hospitals," Times Herald-Record ..................... 88 

"Vets battle bureaucrats," Times Herald-Record ........................ ... ............ ... 89 

"What they say," Times Herald-Record, Augst 5, 1997 ................................ 90 

"Anger and sorrow mark vets' plight,"Poughkeepsie Journal, August 5, 

1997 ................................................................................................................ 92 

Report-''Patient Deaths Under Unusual or Apparently Avoidable Circumstances at VAMCs," prepared by Dr. John Mather, September 26, 1997 130 

Statements: 

Hon. Maurice D. Hinchey, a Representative from the State of New York.. 66 

Hon. Sue Kelly, a Representative from the State of New York, with 

attachments ............................... ........... .... ......... ...... ....... ................. ...... .... .... 69 

Written committee questions and their responses: 

Congressman Evans to Dr. Kenneth Kizer, Under Secretary for Health, 

Department of Veterans Affairs ................................................................ 156,174 

Congressman Evans to Dr. Elwood Headley, Director, VA Medical Center, 

Boston, MA ............. .............................. ................... ....... ........................... .... 163 

Congressman Evans to T.C. Doherty, Director, VA Medical Center, 

Miami, FL ........... ................................................................................... ........ 166 

Congressman Evans to Billy Valentine, Director, VA Medical Center, 

Muskogee, OK ......................... ........................................... .................... .... ... 169 

Congressman Evans to Dr. Lucian Leape, Harvard School for Public 

Health ............................................................................................................ 178 

Congressman Evans to Dr. John Mather, Office of the Inspector General, 

Department of Veterans Affairs .................................................................. 183 
VHA'S RISK MANAGEMENT POLICY AND 

PERFORMANCE 

WEDNESDAY, OCTOBER 8, 1997 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON VETERANS' AFFAIRS, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:05 a.m., in room 

334, Cannon House Office Building, Hon. Cliff Steams (chairman 

of the subcommittee) presiding. 

Present: Representatives Steams, Bilirakis, Moran, Cooksey, 

Hutchinson, Gutierrez, Kennedy, and Peterson. 

Also Present: Representative Evans. 

OPENING STATEMENT OF CHAIRMAN STEARNS 

Mr. STEARNS. Good morning, everybody. The subcommittee will 

come to order and I welcome my colleagues. Over the course of the 

last two years, the VA health care system has undergone dramatic 

change. In many respects, the change has been beneficial for veterans with establishment of systems for providing veterans' routine 

outpatient care, opening of community-based clinics and greater 

emphasis on improving customer service. 

With an accompanying emphasis on the part of VA health care 

managers on cost-cutting and improved efficiency, however, VA employees have faced unsettling times with hospital downsizing reorganization and threats of reduction in force. These sweeping 

changes have made all the more important the need to ensure that 

the quality of VA care remains high. 

This morning we examine one aspect of that obligation, VA's effort to prevent injury to its patients. Patient safety is by no means 

simply a VA issue. We are fortunate this morning to hear from a 

national expert on the prevention of error in health care delivery. 

Dr. Leape's estimate that approximately one million Americans 

are injured by errors in hospital treatment each year and that 

120,000 die as a result thereof is chilling. Our concern certainly is 

to be sure that VA is doing all it can to ensure veterans' well-being 

in its care delivery. VA has sadly experienced some tragic mishaps 

resulting in unexpected patient deaths. 

One can only react with horror at the image of a Miami VA 

nurse interrupting the start-up of a patient's blood dialysis to take 

a personal phone call, returning to find the patient's blood flowing 

from the dialysis machine on to the floor and then attempting to 

cover up the incident, rather than seeking emergency help. 

(1) 
2 

Cases like that lead me to wonder whether a new risk management policy is really the answer. I raise that question with the 

knowledge that VA has had risk management policies for some 

time. For years, a key element of VA policy has been to require 

both system-wide reporting of unexpected patient incidents and national review of that rolled up data to identify trends and institute 

remedial changes. 

I was astounded to learn, however, that until the committee 

asked and recently received tabulated national data on adverse incidents, for years, no VA official had compiled the data, let alone 

analyzed it. If VA headquarters ignores its own policy directives, 

I have to wonder how much trust to place in, quote, "new policy 

pronouncements," however enlightened they might be. 

lt is clear that this hearing raises some uncomfortable questions 

for the department. lt has also become apparent that since we 

began to take a close look at these issues, VA has given the subject 

far more attention and concern. I approach this hearing, therefore, 

with cautious optimism that patient safety has become a critical 

VA issue but, also, with the resolve that this committee will be vigorous in its continued oversight of this area. It goes without saying 

that this is a most important hearing and I very much appreciate 

the efforts of those who came such a distance to be with us this 

morning. I look forward to their testimony. But before calling on 

our first witnesses, I am pleased to recognize our Ranking Member, 

my colleague and friend, Congressman Gutierrez for his opening 

remarks. 

OPENING STATEMENT OF HON. LUIS V. GUTIERREZ 

Mr. GUTIERREZ. Thank you very much, Mr. Chairman. Allow me 

to reiterate the importance of the subject matter of this hearing 

today. Improved patient safety and the prevention of unplanned 

clinical occurrences is a goal we all wish to achieve. In this regard, 

the Department of Veterans Affairs, our Nation's largest health 

care provider, is no different than nongovernmental health care 

providers. However, the VA serves a unique patient base and thus 

carries a unique responsibility to address patient safety. 

The VA as a Government provider is also under the budgetary 

constraints imposed upon it by the Congress and because this committee is responsible for oversight of veterans' health issues, we are 

also responsible for the health of veterans who use the VA for medical purposes. 

I believe this hearing is particularly timely. Unanticipated 

deaths at a number of VA medical facilities have raised our awareness of patient safety issues and the adverse medical effects that 

occasionally result from medical treatments. The statistics do not 

point to a greater number of unanticipated deaths at VA hospitals 

nationally for this year, but cases in Ohio and in upstate New York 

demonstrate the need for new approaches to be developed and implemented to address this problem. 

I am pleased to see the VA start this process. The VA has recently announced a partnership to address these important issues 

in conjunction with other national health care organizations, such 

as the American Hospital Association and the National Patient 

Safety Foundation of the American Medical Association is certainly 
3 

a positive step. The implementation of a comprehensive risk management strategy with concrete proposals for preventing injuries to 

patients, visitors and VA employees is also a useful endeavor that 

should help the VA synchronize its efforts throughout the system. 

Ensuring the quality of care throughout the VA is vitally important. Dr. Kizer has admitted that health care quality varies from 

hospital to hospital; that some hospitals are better than others and 

that some facilities have more reports of adverse events than others. For me, this variance from place to place means we are letting 

some veterans down and I believe by failing to offer the best quality care to all veterans, regardless of their location or network, we 

in turn let all veterans down. 

To address this problem, the recent actions of the VA must be 

followed up by more tangible steps. Access to information must be 

improved, the reporting of adverse events in VA hospitals is even 

more inconsistent than health care. A formal structure should be 

established to ensure that incidents of this nature are reported 

promptly throughout the system. In addition, the number of adverse events facility-by-facility, year-by-year, must be chronicled. 

We cannot determine if the VA health care has improved unless 

we have reliable statistical evidence that VA must make this an urgent priority if it is to address the issue in a responsible manner. 

Allow me once again to express my support for what the VA is currently doing to improve patient safety. These are positive steps 

worth commendation and they should help us all understand the 

true nature of this problem and assist in the creation of innovative 

solutions. I thank you all for joining us here today on this important issue and I look forward to questioning the witnesses later 

this morning. Mr. Chairman, thank you so much. 

Mr. STEARNS. Thank you. My colleague from Florida, Mr. Bilirakis. 

OPENING STATEMENT OF HON. MICHAEL BILIRAKIS 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I ask unanimous consent my entire statement be made a part of the record. And Mr. 

Chairman, I would like to commend you for scheduling this hearing. I do want to thank you for postponing it from the prior date. 

As you know, I had FDA reform at that time and I wanted to be 

here. I also would like to join you and others in welcoming Dr. 

Doherty, the Director of the Miami VA Medical Center, here to 

Washington. 

Earlier this year, Mr. Chairman, as we all know, one of my district newspapers printed a series of articles on VA health care. 

These articles chronicled the stories of a number of patients who 

died unexpectedly because of adverse events. That paper reported 

that at least 23 veterans have died under unusual or avoidable circumstances at 17 VA hospitals and nursing homes around the 

country since 1993. These articles also recounted a series of mistakes that resulted in the deaths of 23 veterans in Florida and I 

won't go into those specific adverse events, Mr. Chairman. I suppose in our hearing today, it will go into those, but it is tragic. 

I think it is important we realize as tragic as these events are, 

the purpose of today's hearing is not to condemn the VA health 

care system. In fact, I have always believed that the VA health 
4 

care system is a national asset that provides high quality care to 

our Nation's veterans. I am concerned, obviously, that events such 

as this sort of lessen the credibility in veterans' minds of the VA 

health care system, and I think that is the biggest problem with 

it all. 

Over the years, I visited, as have many others, VA health care 

centers. I have also heard from many veterans who have taken the 

time to share their positive experiences at VA medical facilities 

with me. Moreover, Mr. Chairman, it is important we realize adverse events are not unique to the VA. 

A 1993 Harvard study estimated one million preventable injuries 

and 120,000 preventable deaths occurred at American hospitals in 

a single year. While we would obviously prefer that adverse events 

never occur at any hospital, it is unrealistic to think that such 

events can be completely eliminated. After all medical providers 

are human and mistakes will occur if only by human error. So 

rather than set an unachievable goal, it is the responsibility, I 

think, of this subcommittee to ensure that when an adverse event 

does happen, it is properly investigated by the VA in a timely manner. Moreover, it is important that the VA establish appropriate 

risk management policies, as you indicated, to prevent such events 

from occurring. 

We must also conduct proper oversight to ensure the risk management policies are being followed by VA medical personnel. This 

is particularly important because of the significant changes that 

have taken place within the VA health care system over the last 

couple years. These changes were designed to reduce health care 

costs and increase the timeliness of care provided to veterans. 

As the reorganization of the VA health care system continues, we 

must monitor the impact that these changes have on the quality 

of care veterans receive in VA medical facilities. Simply put, Mr. 

Chairman, veterans deserve to know they will receive the highest 

quality of care of VA medical facilities, and it is our job to make 

sure they do. I thank you, Mr. Chairman, for scheduling this hearing and, hopefully, we can get to the problems. 

Mr. STEARNS. I thank my colleague. The Ranking Member of the 

full committee, Mr. Evans. 

OPENING STATEMENT OF HON. LANE EVANS, DEMOCRATIC 

RANKING MEMBER, COMMITTEE ON VETERANS' AFFAIRS 

Mr. EvA.~s. Thank you, Mr. Chairman. I guess I want to associate myself with the remarks just made by our colleague from Florida. You all know that this issue is a very important one. We congratulate you for holding this hearing. We know it goes to the 

heart of the basic issue of providing quality health care to our Nation's veterans, and when we have preventable mistakes occurring, 

it is often sensational and graphic in the media reports we receive, 

but I think as shocked as we all are, we need to keep these events 

in perspective as the gentleman from Florida indicated. Every system has its problems. 

One of our committee staff members shared an experience about 

the potentially life-threatening mistakes in her father's health care 

under one of the Nation's most preeminent health care organizations, so we must not characterize the VA by the number of unfor-
5 

tun ate incidents that have occurred. We need to be practical and 

make sure they don't occur again and I completely associate myself 

with the remarks made by the gentleman from Florida. 

Mr. STEARNS. Mr. Moran. 

OPENING STATEMENT OF HON. JERRY MORAN 

Mr. MORAN. Mr. Chairman, thank you. I appreciate the opportunity to hear the testimony today and I congratulate you on having this subcommittee hearing. I think all Americans have a right 

to expect quality health care when they are admitted to a health 

care system, and it is especially true for veterans who have served 

our country and who are receiving medical care provided by the 

United States Government, so I think this is a very important topic 

and I appreciate the opportunity to participate in today's subcommittee meeting. 

Mr. STEARNS. Mr. Peterson. 

Mr. PETERSON. Nothing. 

Mr. STEARNS. Without objection, all Members' opening statements will be made a part of the record. 

And now we will start with the first panel, Dr. Leape, from the 

Harvard School of Public Health. Welcome, this morning, and we 

will have your opening testimony. 

STATEMENT OF LUCIAN LEAPE, M.D., HARVARD SCHOOL OF 

PUBLIC HEALTH 

Dr. LEAPE. Mr. Chairman, members of the committee, thank you 

very much for the opportunity to come and testify before you. Although I am currently at the Harvard School of Public Health, I 

want to make sure you know that I am a real doctor; that for 25 

years I was a practicing pediatric surgeon, so I think I have some 

understanding of these problems from the trenches as well as from 

academe. I also am a veteran so I have an interest in what is going 

on. 

I have not, however, studied the Veterans' Administration hospitals, but I have no reason to think they are any different from 

the rest of the hospitals in the country in terms of the nature of 

the problems and the way they are approached. As the Chairman 

has pointed out, we have a serious problem. We have far too many 

injuries and deaths as a result of treatment that is designed to 

help people, and it is very important to try to understand why that 

occurs so we can do something about it. 

Clearly, health care is a high hazard industry. It has not thought 

of itself that way. We think of ourselves as a highly effective industry and, indeed, in the last 10 or 20 years, the improvements in 

medical science have, indeed, been breathtaking. We are highly effective. We are now, of course, also highly technological and highly 

complicated and complexity breeds opportunities for error and that 

is how injuries happen. 

But other industries are also high hazard, highly effective, high 

technology industries but have much lower injury rates. I think, 

first off, of aviation and nuclear power. Nobody questions the fact 

that these are very risky enterprises and yet they go wrong very 

seldom. What do they know that we don't know? Why is it that 

when you enter a hospital, your chances of dying from an accident 
6 

are one in 200, but when you climb on an airplane, your chances 

of dying in an accident are one in 2 million? 

Clearly, we can learn a lot from what has been done in industry 

and it is time we apply these lessons to health care. Why haven't 

we done something before this? I would submit there are three 

basic reasons: The first is that the leaders in our hospitals have 

been unaware of the severity of the problem. It has only been in 

the last few years that these reports have come out that show the 

high incidence of injuries and accidents and errors, and the other 

reason is they don't receive the reports within the hospital. 

The reason we don't get voluntary reporting is that we punish 

people when they make errors, and, therefore, no one is going to 

report an error they can hide. These egregious incidents you have 

heard of already increase the fear that is so present in our hospitals among personnel concerning errors, and until we change 

that, we are not going to get good reporting. We may be able to 

snoop around as policemen, but we won't be getting the voluntary 

reporting. 

The second is that our method for dealing with errors is misguided and ineffective. Our focus, traditionally, since time immemorial, has been on the individual. We attempt to get perfection in 

care by training doctors and nurses and pharmacists to be perfect 

and then punish them when they fail. The "train and blame" approach has been shown to be ineffective and the results speak for 

themselves. 

The high hazard industries that have low risks, such as aviation, 

do not get there that way. They have found, as we have learned 

from human factors experts over the years, that errors are not 

made on purpose, and that errors don't occur out of the blue, but 

that human beings make errors because of the situations, the processes, that they are functioning in; that is, defective systems make 

errors more likely and more difficult to pick up. Pilots aren't any 

better than doctors, but they make fewer errors because their systems make errors more difficult and when errors do occur, and they 

make errors also. They can identify them and correct them before 

an accident happens. So we have to think in terms of systems 

terms, rather than individual terms. 

When something goes wrong, we always want a head to roll, we 

look for somebody to blame, we cry negligence and abuse and so 

forth. Very, very few of our errors, I would say less than 1 percent, 

are due to real negligence. Most are made by good conscientious 

people that make a dumb mistake, just like you and I do every day. 

Errors are part of human experience. 

What we need to do is to have systems that keep them from 

hurting patients. For example, two medications that have similar 

looking labels are an accident waiting to happen. Two medications 

with similar sounding names are an accident waiting to happen. 

Nurses and doctors who work double shifts and have increased patient loads, who are tired and under stress, those are accidents 

waiting to happen. We all know that stress makes you more likely 

to make a mistake and yet doctors and nurses and pharmacists are 

often under great stress. 

The recent tendency to substitute less trained people for highly 

skilled nurses in our care of patients is absolute idiocy at a time 
7 

when the intensity of illness in hospitals has gone up, as more and 

more patients are taken care of outside. At a time when care has 

become increasingly more complicated, we are reducing the level of 

expertise of people delivering the care. This is absolute madness. 

It is a setup for errors and it is not surprising they occur. 

Illegible handwriting has long been a big joke. Doctors' handwriting has always been known to be something you can't read. It 

is not a joke when it leads to the wrong medication or wrong dose. 

This is something we should eliminate. And so it goes. So we have 

a lot of things in our system that, if you will, set up people to make 

mistakes. 

In fact, I would say the nurses and the pharmacists and the doctors are our best defense against these defects. They don't make 

mistakes most of the time. They keep from doing the things they 

are being set up to do. 

The third reason, in addition to the fact that our efforts have 

been misguided, is that hospitals and health care organizations 

have not made safety a number one priority. I think it is quite evident the time has come to do that. We have to stop reacting to crisis events and start being proactive in thinking about how to design our systems. It has already been mentioned there has been 

some recent progress. I think I should take one minute to mention 

that. 

Last October, there was an exciting conference sponsored by the 

Annenberg Center in which we brought together members from the 

health professions as well as industry and academics to talk about 

error prevention. At that time, the AMA announced its formation 

of the National Patient Safety Foundation, specifically committed 

to improving information dissemination, education and sponsoring 

research in error prevention. I think this is a significant step forward by the AMA, and they ought to be commended for it. 

At the same time, the Joint Commission on Accreditation of 

Health Care Organizations announced it was changing its reporting policy, to make it less punitive and more constructive. The 

American Society of Health-Systems Pharmacists published a list 

of eight or nine major features that hospitals should incorporate to 

prevent errors. If these were adopted by all hospitals in the country, errors in the medication process would be significantly reduced. And hospitals are beginning to do something about it. 

We had a collaborative effort to reduce medication errors run by 

the Institute for Healthcare Improvement. We had 41 hospitals 

signed up and another 20 that we couldn't take, so there is an interest and demand; hospitals are trying to do something about it. 

We need to help them as much as we can. However, it is going to 

take a major culture change. It is going to take hospitals beginning 

to look upon errors as what they are, which is symptoms of a disease, not the disease itself. The disease is faulty systems. Until we 

concentrate on the system faults, we are not going to stop the errors. It is time to shift the target away from the people and on to 

the process. 

There are several things we could do right up front. It is time 

to move ahead with the electronic medical record. It is madness 

that we have medical records that nobody can read. It is time to 

move to computerized physician order entry so when doctors make 
8 

an error, the computer picks it up and corrects it before it gets executed. It is time to implement bar coding of medications. We do it 

in our supermarkets, but we don't do it in our hospitals. 

The pharmaceutical industry ought to be called upon to bar code 

every drug and to bar code all unit doses, and hospitals should 

have bar coding of medications and bar coding of patients to prevent error. I am optimistic. I think what the VA has done with its 

new risk management policy is a step in the right direction and I 

think hospitals throughout the country are making a lot of 

progress, but we have a long way to go. Thank you. 

[The prepared statement of Dr. Leape appears on p. 93.] 

Mr. STEARNS. Thank you, Dr. Leape. I have an article in front 

of me from the Washington Post, dated October 7, and, basically, 

Dr. Kizer, who is the VA Under Secretary for Health, indicated 

that despite all the incredible advances in medical science of the 

past several decades, the simple fact is too many adverse events 

happen as a result of medical treatment, which pretty much corroborates what you have just said. 

Obviously, the statistics of 1 in 200 in a hospital, versus one in 

two million in an airline is something we have to work harder on 

and it is scary, frankly, to think about it. Further on in this article, 

near the end, you say that basically you hail the VA for taking, 

quote, "a giant step forward," end quote, by joining the effort to improve patient care. 

My question is, while your testimony or your comment in the 

newspaper praises the VA's, quote, "new risk management policy" 

and the potential it holds, in terms of measurable outcomes or results, how could this committee best assess the effectiveness of that 

policy, particularly in the absence of baseline data? 

Dr. LEAPE. It is going to be very difficult. They are no different 

from any other hospital. We don't have good baseline data anywhere because we have had very limited reporting in the past. We 

estimate that fewer than 5 percent of significant errors get reported and I have no reason to think the VA is any different from 

any other hospitals in that regard, so it is difficult to assess improvement. 

What can be done, however, is to take some baseline measurements now. This can be done in the form of focused audits. One can 

identify certain specific kinds of errors that are known to occur. 

One can do a survey of one or two units, nursing units in a hospital, and get a fix, if you will, on what the baseline rate is, so it 

is possible with intensive review of records and discussion with 

personnel, to get a good idea of where you stand and then reassess 

it by the same method a year or two later. But you do not have 

baseline data, you are absolutely correct, and neither does anyone 

else. 

Mr. STEARNS. So let me review. You know, it was disappointing 

for us in the committee to realize that this information was not 

regularly sent, and if it got there, it was just put into a room and 

it was not looked at on a periodic basis. So this baseline data is 

absent, and we don't have any way to evaluate it. Is there any difference between what is being done-what occurred in the VA and 

in the private sector. 
9 

Dr. LEAPE. Not to my knowledge and as a matter of fact, one of 

the disturbing things is most hospitals have incident reporting systems and we found, number one, they miss 95 percent of the 

events. Number two, usually nothing happens after a report goes 

in. 

One of the frustrations of medical personnel, nurses and doctors 

is they file a report and never hear anything back and nothing happens and that is unfortunately all too typical now. I obviously can't 

speak for all hospitals, but in the ones we have looked at that has 

been characteristic and this has got to change. I think it is changing, and that is why I complimented the VA on trying to change 

it, but it is not surprising it wasn't there before. 

Mr. STEARNS. So you are saying that what occurred in the VA 

system is typical of what occurs in the private sector. 

Dr. LEAPE. I believe so. 

Mr. STEARNS. So the nurses will offer the information, but low 

and behold, no one looks at it. There is no one who studies the 

baseline data and comes up with any conclusions. 

Dr. LEAPE. Of course, that is not a blanket statement that applies to all hospitals in the country because some do, but in general 

it tends to be more that way than the reverse, unfortunately. 

Mr. STEARNS. Well, how do we know that once we institute the 

new system that Dr. Kizer is talking about, and I commend him 

for it, that we are going to have any new results. That is really a 

question for Dr. Kizer. But my concern is, in your testimony you 

counsel against blame and punishment as tools to minimize clinical 

tools. In the private sector, if there is not performance, if there are 

continued adverse problems, they make change, they do something 

about it. This whole idea of blame and punishment in a medical 

center, should we use that as a means to implement new procedures, if we find, for example, one institution, one VA hospital, that 

has an enormous or adverse risk that is out of the norm, I mean, 

should there be some type of management reform, new safety 

measures done at that institution? I mean, we can collect all this 

information, but if you have an institution that is managed in such 

a way that safety is not preeminent, I mean, I guess what I am 

saying is what is the enforcement mechanism and is blame and 

punishment a motivator? 

Dr. LEAPE. Well, I think what you are suggesting is what most 

regulators suggest. In other words, what is the rule and how do we 

enforce it? The evidence is that that is not the way you reduce errors. You have a fiduciary responsibility to monitor what they are 

doing and therefore you need to have data and you need to follow 

it, but that alone is not going to get you where you want to go. 

We really have to have a climate where people feel free to talk 

about their errors and where people think of errors as systems 

problems, not people problems. You still think of them as people 

problems. I was that way. When I had residents, I would chew 

them out when they made a mistake. It never occurred to me when 

I made a mistake it was something in the system; I always thought 

it was me. But experts say that isn't the way it is and again I come 

back to aviation. 

They have been fantastically successful and they have been successful because they have looked beyond the individual and said 
10 

let's try to figure out what is going wrong so we can prevent it from 

happening again. So if you want to improve safety in the VA, you 

have to change the climate. That won't be easy. It will take time 

and, number two, you can legitimately expect each hospital to have 

in place features that we know reduce errors. 

For example, every hospital should have, I assume they do, but 

I don't know this, should have the unit dosing system, which reduces medication dose errors by 80 percent. Every hospital should 

have within 5 years computerized physician order entry. Every hospital should have within 5 years electronic medical records. Every 

hospital should have a full-time pharmacist and so forth and so on. 

So there are a number of things that we know make a difference 

and there is no excuse for them not being done and you can certainly monitor that. You certainly want to get a fix on what the incidence of adverse events is, but if you really want to have errors 

drop, it is going to require culture change and that isn't going to 

happen overnight. 

I think this policy sounds as if that is what they are trying to 

do. They are trying to be proactive. They are trying to put an emphasis on involving people and getting every individual thinking 

safety. They don't think that way now, and if the VA could get its 

people in the trenches, the people in the units, thinking safety and 

realize when they have an idea, it is responded to and people make 

changes, then things will improve. I think you need to keep the 

heat on them to do that, but it seems to me they are trying to do 

that from what I read here. I have no, you know, firsthand knowledge. 

Mr. STEARNS. I think that is a significant point and at this point 

I tum over to the Ranking Member, Mr. Gutierrez. 

Mr. GUTIERREZ. Thank you. Doctor, could you share with us 

some specific examples that you might know of hospitals, medical 

institutions, things that have happened there and actions that particular institutions have taken? 

Dr. LEAPE. You mean specific awful events? They have been in 

the newspapers. 

Mr. GUTIERREZ. No. 

Mr. LEAPE. You don't mean that. 

Mr. GUTIERREZ. Specific actions that have been taken by the 

medical institutions, like a medical institution, things that have already been done. Here is what was going on; here is how they addressed it so that we can get a sense of what is happening. 

Dr. LEAPE. Sure. We got very interested in the whole business 

of computerized physician order entry because if the doctor has to 

order the medication in a computer, the computer will remember 

that the patient is allergic, which the doctor might forget, the computer will remember the patient is on another medication which 

interacts badly with it, so you can prevent errors by computerized 

prescription entry. And of two major hospitals we studied, one was 

going to implement that, the other hospital was not all ready to do 

that yet. They weren't set up. They didn't have the money and so 

forth. 

As an alternative, what they did was they got their pharmacist 

to come out of the basement and come up on the floors and make 

rounds with the doctors and nurses. Well, the pharmacist is a gold 
11 

mine of information about drugs, I mean, that is what he knows, 

and they found with the pharmacist there that the physicians 

would ask them for advice and so forth. The pharmacist would see 

something going wrong and he would make an offer, and in a 6-

month period, we found that the pharmacists had made 394 recommendations of changes, and the doctors had accepted 390 of 

them. 

I mean, there wasn't much question that this was well-accepted. 

The nurses thought it was wonderful because, of course, they didn't 

have to go get the orders changed and so on. So the simple device 

of having a pharmacist make rounds with the team is a great step 

forward. Others have worked on the handwriting problem. They 

have sent the orders back to the doctors and said, you know, we 

can't read this. That sounds pretty obvious, but it wasn't being 

done and they have standardized their procedures to make sure 

that orders are correctly written. 

Chemotherapy is a hazardous form of treatment, as you know. 

People can die from their medications, and it is too easy to give an 

overdose because it's so complicated to compute these. Every drug 

has a different system and they give so much per day for how 

many days and so forth. Well, you can reduce errors greatly in that 

by merely having a pre- printed form in which the person is led 

through the calculations in which the weight and height and all 

those things are in, so they are less likely to make a mistake than 

if they just remember the dose and write it down. So some of the 

things are exceedingly simple. Bar coding is exceedingly simple. 

Mr. GUTIERREZ. What does bar coding exactly do, Doctor? Tell me 

the benefits of bar coding. 

Dr. LEAPE. Well, with bar coding, with a simple wand, you can 

identify that the medication you are about to give a patient is the 

right medication and that it is for that patient and then you can 

bar code the patient and make sure it is the right patient. You can 

link up the drug to the right patient, right drug, right patient, 

right dose, and this has been done in some institutions with significant reduction in errors. 

Mr. GUTIERREZ. And what can the VA do to encourage its clinicians to report quickly adverse-what kinds of things have been 

done in other settings. You said it is a systems problem, and that 

it takes time to change, so what have people done, and what can 

you recommend they do, to encourage a change and more honesty 

in coming forward. 

Dr. LEAPE. This is a leadership issue, isn't it, so the chairman 

of the department of medicine or surgery has to believe in this and 

he has to communicate it down. So if you want to change the culture, you have to change it from the top down, and this hearing 

today may help start it. But you have to have the heads of the hospitals understand and believe-it is not a religion, but it sounds 

like it. You really have to believe the way to make improvements 

is to take the focus off people and put it on the system. 

Once you believe that, it gets transmitted readily. So if the chairman of surgery at the weekly morbidity and mortality conference, 

we always had weekly morbidity and mortality conferences, if it is 

quite clear to everybody there that the name of the game is to try 

to understand why it happened, not try to figure out who to blame, 
12 

the information will pour out. We had one nurse supervisor at our 

training sessions who went home and decided she was going to try 

this out because she really thought it made a lot of sense. She convinced the other nurses she was sincere that they were not going 

to be punished. She said "I really want to know what has been 

going on." 

The number of reported errors in that unit were approximately 

eight per month for the preceding year. In the month after this 

happened, they had 160 reported, a 20-fold increase from merely 

the nurse saying we are going to change the way we do business 

here. We think errors are symptoms. We think you are good people. 

The errors are made by good people trying to do a good job, but 

we all make mistakes every day. If you really say let's get the focus 

off the individual and onto the systems, miracles happen. 

Mr. GUTIERREZ. So unless you change the leadership, you are not 

going to get the information and until you get the information, you 

can't correct the situation. 

Dr. LEAPE. Absolutely. 

Mr. GUTIERREZ. Mr. Chairman, thank you very much. I agree 

with you. I go to the hospital, I relax, I get on an airplane, I tense 

up. 

Dr. LEAPE. You've got it backwards. 

Mr. GUTIERREZ. According to Dr. Leape, I got it kind of backwards. But that is the way I think most of us probably feel. You 

have a sense of confidence and here is your doctor-not that I don't 

confide in the airline pilots, but I just feel like I don't get on an 

airline and get help. I go to my doctor and hospital to get help and 

there are professionals there. And you are right, we do have to do 

some things, even in the private sector. And if you visit even a 

manufacturing site, there are signs that say so many days without 

an accident, and they do have recommendation boxes, at good 

plants, you know, where people put their recommendations for 

safety and there is a safety box and there are all kinds of incentives to give workers so they can tell and take pride and actually 

report what is going on so they can do that. Thank you very much, 

Doctor, I really appreciate your testimony this morning. 

Mr. STEARNS. Thank you. Mr. Bilirakis. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. Dr. Leape, you have 

been very helpful and all of us really appreciate you taking the 

time to be here. Let me go back, and I don't want to spend very 

much time on this, but that 1993 Harvard study that estimated, 

that one million preventable injuries and 120,000 preventable 

deaths occurred in American hospitals in a single year. When the 

study came up with that figure, and I realize the word "estimated" 

is in there, this is versus how many total preventable injuries and 

versus how many total injuries and how many total deaths 

occurred. 

Dr. LEAPE. Those numbers were extrapolated from a study that 

was done in New York State in which 30,000 hospital records were 

looked at, random sample, all kinds of hospitals, and tried to get 

a population estimate. Most studies come out of one hospital, and 

they are often teaching hospitals and, you know, they are not representative. So we think it is reasonably representative. You may 

come from Idaho or Mississippi, you may not think what happens 
13 

in New York is representative, in which case you can adjust, but 

we extrapolated. 

From that we found there were 1.3 million injuries and 69 percent were related to an error, so 69 percent times 1.3 comes out 

to be approximately 1 million. We estimate a total of 1,180,000 

deaths. Two-thirds of that is 120,000. So two-thirds of all the injuries, 69 percent, we found, were due to errors. 

Mr. BILIRAKIS. Preventable. 

Dr. LEAPE. And therefore preventable, yes, right, by definition 

preventable, potentially preventable. 

Mr. BILlRAKIS. Well, you know, Doctor, you are right. I know Mr. 

Gutierrez mentioned a change in leadership. I don't know about 

changing the leadership, but I think everybody meant and he 

meant changing- the culture, changing the thinking, if you will. I 

know we have had many instances in our hearings over the years 

here where there is great concern expressed by veterans, and I 

think we have all seen it if we visit enough centers, that a lot of 

the personnel there-I don't necessarily mean the medical doctors 

and what not, but a lot of the personnel have a feeling of, oh, well, 

the people here are on welfare. In other words, they don't treat the 

veterans with the respect that they certainly deserve, so that is a 

culture, even though it may be a lower level of clerk or whatever 

the case may be, it is very important. 

I know that a few years ago, maybe the 2 or 3 years before the 

series of articles on VA health centers appeared, there was an article in the local newspaper in Florida, of a particular local hospital, 

where a doctor was involved in deaths. I think it was during open 

heart surgery and the articles indicated that that doctor had been 

involved in other incidences prior to these immediate deaths that 

the article referred to. The reason why he wasn't let go by the hospital is because the doctor threatened to sue them, and they were 

concerned about a lawsuit. They would go bowing out of the culture 

and that is really a part of it, is it not? 

Dr. LEAPE. The whole malpractice situation overlays this. You 

see, doctors are told by their lawyers not to tell the patient anything. You can't even say I'm sorry. All of that is designed to focus 

on a bad apple. All the best surgeons I know, and a lot of the best 

surgeons are my personal friends, every one of them has been sued. 

Now, they are not negligent, they are not bad apples, but the system does that and therefore doctors are inhibited and they are reluctant to participate in this. They don't want to report errors. Why 

should they incriminate themselves? That is a very major issue. It 

may be less of a problem in the VA, I don't know, but it is a very 

major issue we have to deal with. 

Mr. BILlRAKIS. Reform is something you feel is a major issue and 

is required. 

Dr. LEAPE. Absolutely, yes. 

Mr. BILlRAKIS. You also mentioned, and I guess this goes maybe 

to cultural thinking, cultural changes, but my oldest son is now a 

physician and part of his residency was included at the VA hospital 

in Tampa. I think back 3 or 4 years ago. I think back to the hours 

the people worked. You talked about the stress. Is that changing, 

these fantastic hours that these residents work and certainly it has 

to result in some problems taking place. 
14 

Dr. LEAPE. You may remember that New -iork State passed regulations a few years back in reaction to the Libby Zion case to restrict the hours. There was a tremendous resistance to change, particularly in the surgical community, because, again, the culture, 

really what I grew up in, is that you have to be there and be with 

the patient day and night to really understand what is going on 

and to develop your sense of responsibility. 

One of the most important things we want to develop in young 

doctors is a sense of responsibility and it certainly does that. It also 

makes you so tired that if you have an operation the next day, you 

may have trouble keeping your eyes open. That is a long way of 

saying there have been some efforts, but they haven't been very 

successful, and people who look at this from the outside are aghast. 

Health care is the only industry in this country that doesn't seem 

to believe that fatigue degrades performance. If you are a pilot, you 

are forced to take hours off between flights at night and the idea 

that surgeons and anesthetists can be up all night doing an emergency operation and then at 8 o'clock the next morning start a new 

case, that is madness, yet it happens in every hospital. 

Mr. BILlRAKIS. So the bottom line of what you are basically telling this committee is the problems at the VA are similar to the 

problems in health care throughout America and probably throughout the world. 

Dr. LEAPE. Absolutely. 

Mr. BILlRAKIS. And the way they are going to be correctable is 

not just at the VA, but throughout the entire-really, throughout 

the medical world. 

Dr. LEAPE. But you, of course, can be part of this process and 

things like this new policy, I think, are a leadership move. If it can 

be implemented, if you can do the things there that is moving 

ahead and if the VA does some exemplary things, other hospitals 

will learn from that, so I think you have an opportunity for leadership here, I really do. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. 

Mr. STEARNS. Mr. Evans. 

Mr. EVANS. Thank you, Mr. Chairman. Picking up on the gentleman from Florida again. Based on your knowledge of the VA and 

other health care systems, are VA patients more likely than patients of other systems to experience an adverse event that results 

in serious injury or death. 

Dr. LEAPE. I have no idea. I don't have any data on that. 

Mr. EVANS. All right. Well, VA has obviously been influenced by 

your work in developing their current risk management guidance. 

Do you have any views on the adequacy of their new policy and 

does it compare to policies used by other major health care systems? Are there good models that it might follow? 

Dr. LEAPE. As I look at this policy, and I haven't looked at VA 

hospitals or their data, but I have looked at this policy; there are 

several features of it that strike me as really exemplary, and as I 

say, if they are implemented will be a real move in the right 

direction. 

First of all, it is a proactive policy. Most error programs, error 

prevention programs, or what are often called risk management 

programs are reactive. Somebody does something awful and we 
15 

have a big shake-up and try to change the system. This policy is 

an attempt to get the frontline people: nurses, doctors, pharmacists, to identify accidents waiting to happen and redesign the 

system before that happens. 

If you can do that, you are really on the right track. We have 

to do more than just react to disasters and this attempts to do that. 

Secondly, it attempts to-it sets as a goal-to incorporate the 

concepts of continuous quality improvement into the everyday routine of the nurses and doctors in the hospitals. That is, thinking 

of themselves as part of a team to ensure safety, to be thinking 

about how to make the process better. That has to do with reporting and then getting some feedback and some response when you 

report. 

If that can be done, that is going to be one of the most important 

things you can do to improve quality. Third, they are setting up an 

Intranet, not an Internet, an Intranet, a computerized Internet 

within the VA hospital system, which not only nurses or doctors or 

any personnel can report things they have learned about a way to 

prevent a certain kind of error, but the results from the review by 

the Office of Performance and Quality and by the Medical Inspector 

will be distributed through this. 

Aviation has this and pilots read these things avidly. If we could 

learn from each other's mistakes, which is what this tries to do, 

clearly that would be helpful. You know, you have 173 hospitals. 

You have 173 potential laboratories for improving the way things 

are done and if that information is disseminated, clearly that will 

be a good thing. So I think these are very important and impressive features. 

Also, the emphasis on promptly informing patients, that doesn't 

happen in most hospitals. That is one of the reasons lawsuits happen, but patients are often the last to know that there has been 

an error, so one of the policies listed here is that patients will be 

promptly informed of what is going on. 

It has a lot of bureaucratism in it and it has a little too much 

regulation for my way of thinking. It reminds me of my days in the 

Navy, but on the other hand, the goals are good and what they are 

trying to do makes a lot of sense, and I think if you can implement 

it, it will be a giant step forward. 

Mr. EVANS. Thank you. 

Thank you, Mr. Chairman. 

Mr. STEARNS. Mr. Hutchinson. 

OPENING STATEMENT OF HON. ASA HUTCHINSON 

Mr. HUTCHINSON. Thank you, Mr. Chairman, and I apologize for 

coming in late, but I want to assure you, doctor, that I have read 

your testimony and I very much appreciate your participation in 

this hearing, and I thank the Chair for conducting this very important hearing. 

I was intrigued with some of your comments and the emphasis 

upon systems to help correct errors and a different approach to it. 

Even under a systems approach, though, errors will still occur, but 

the whole object is to provide more training, positive reinforcement, 

and systems to correct or define the errors and prevent them. 

Dr. LEAPE. Right. 
16 

Mr. HUTCHINSON. Am I getting the gist of that? 

Dr. LEAPE. That is right. It is not possible to make things perfect, but you approach perfection and part of your approach is twopronged. One is to make it much more difficult for errors to occur 

and, secondly, to make it possible to intercept them before they 

cause harm. That is the goal, and you are right now say at a 50 

percent level. Get to the 90 percent level in 5 yeers and 5 years 

later get it to the 95 percent level, and keep on closing in until we 

get to a 99.9 percent perfection. 

Mr. HUTCHINSON. Which is exactly where we want to go, but 

there is always going to be some errors that sneak through and injuries as a result of that. I was intrigued by your comments on the 

tort system and in your written testimony, you talk about the tort 

system focus on the individual who made the error causing an injury, assuming that punishment will make the person less likely to 

err again. 

The concept of a systems cause is really considered. Just a comment on the tort system, though. The tort system is not designed 

for punishment, but it is designed for compensation, and even if 

you have a good systems approach, there are still going to be some 

errors that happen, some injuries that occur and compensation is 

still going to be important, would you agree? 

Dr. LEAPE. You are touching on a subject that is dear to my 

heart. I happen to think we should compensate everybody for their 

injuries. I think hospitals should be required to pay the cost of 

health care for everybody that is hurt by treatment because right 

now the health insurance mechanisms, among people outside the 

government hospitals, only pay about three-fourths of the cost, and 

the patient ends up picking up the rest of it, and those costs are 

sometimes substantial. 

Insurance doesn't cover it, they can't get insurance for that and 

so the patient is left holding the bag. If hospitals had to pay the 

cost of injury, they would have a tremendous incentive to reduce 

injuries and that is probably the single thing we could do to make 

the most difference, and I don't think the chances of that happening are very great. 

Mr. HUTCHINSON. Yes, I think you answered my last question, 

which you raised the question in your written testimony about 

should hospitals and health care organizations, instead of physicians, be held responsible for adverse events. I think your answer 

is that should be looked at very affirmatively. 

Dr. LEAPE. Resoundingly, yes. 

Mr. HUTCHINSON. Now, a follow-up question would pain and suffering be included in your compensation? 

Dr. LEAPE. That is a sticky one. In Sweden and other countries 

where they have attempted to do things like this, they have not included that. Interestingly enough, if you talk with patients who 

have been injured, they want two things. They like to hear the doctor say I'm sorry and they like to see that the health care system 

is going to do something to keep that from happening again. Money 

is a distant third objective and I think the pain and suffering thing 

is all part of the anger that comes from a doctor that won't talk 

to them and a system that won't do anything. That may turn out 
17 

not to be very important if we really had a good system of dealing 

with errors. 

Mr. HUTCHINSON. I think that is a good observation. I am not 

sure I agree 100 percent, but it is a good observation. And in regards to the admission of error, if the doctor says I'm sorry or whoever is responsible, and I am sure as part of your job you have reviewed medical records, is there hesitancy now for doctors to put 

in medical records all of the facts that might make them look bad. 

Dr. LEAPE. Absolutely. I have never seen a record that said I 

made a mistake. 

Mr. HUTCHINSON. I am not sure I have either. 

Dr. LEAPE. I certainly never wrote that. 

Mr. HUTCHINSON. Is there any system that can be developed that 

would help in that regard. 

Dr. LEAPE. Sure. What we are talking about: If the physician is 

functioning in a hospital, in a department, where the understanding is that he or she is trying to do a good job and made a mistake, 

didn't make it on purpose. Let's see if we can figure out how to 

keep anybody from making the same mistake again. We are really 

sincere about it and the discussions are confidential and, of course, 

under the peer review statutes they are nondiscoverable in most 

States, so we don't need a law to do this. But if we had that kind 

of a system, then the physicians would be very interested in doing 

that, because all health workers want the same thing as patients 

want. They want to figure out a way to keep the mistake from happening again and the way you do that is to start talking about It. 

I don't think there is any question they would participate. 

Mr. HUTCHINSON. Doctor, thank you very much. 

Mr. BILIRAKIS. Will the gentleman yield for a minute? 

Mr. HUTCHINSON. Certainly. 

Mr. BILIRAKIS. Getting back to the immediate conversation, Doctor, you would have a strict liability type of a thing insofar as 

health care is concerned. 

Dr. LEAPE. Yes, this is very controversial obviously. We have had 

a couple States that have had some interest in implementing this 

and whether it will come to pass, I don't know. We should try it 

out at a State level to see what the problems are. But if you think 

about it, if you really believe systems failures are the cause of errors, you need to put the responsibility on the party that can do 

something about the systems. 

Doctors can't change the systems by themselves; the hospital has 

to do that. So if the hospital were responsible for the consequences 

of the injuries, the hospital would have a strong incentive to try to 

reduce that and would think about changing systems instead of 

just fingering the individual. 

Mr. BILIRAKIS. You would have, then, a process where it would 

have to be determined whether this was a preventable injury versus a nonpreventable one; isn't that correct. 

Dr. LEAPE. Well, I would make it for all injuries caused by treatment, as opposed to caused by the disease. I mean, not complications of the disease, but all complications of treatment, yes, because 

the nonpreventables hurt just as bad as the other. 

Mr. BILIRAKIS. Give me an example of a nonpreventable, that is 

not the cause of disease. 
18 

Dr. LEAPE. Sure. You wouldn't have to compensate for this but 

a rash from a drug, a person is allergic to a drug, it was not known 

before, they got the drug for the first time, they had an allergic reaction. At the present time, we have no way of preventing that. It 

could be fatal, all the way from a simple thing like a rash to being 

fatal. It is not the doctor's fault that happened and we don't have 

any mechanism for compensating them, so I think that the hospital 

should pay that and then the hospital would work on it. They obviously couldn't do anything about those, but they would work on the 

ones that are preventable, which are two-thirds of them. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. 

Mr. STEARNS. Mr. Peterson. 

Mr. PETERSON. Thank you, Mr. Chairman, and thank you, Doctor, for giving us some compelling testimony here. I just wonder, 

how realistic it is that we can get to some of the places you want. 

You talk about a change in leadership. It seems to me that maybe 

people sitting around this table might be a key component of that. 

Right now, we have a situation where everybody is beating the 

heck out of the IRS because they are doing what we told them to 

do. Listening to what you are saying, it makes a lot of sense to me, 

but it just seems that your solutions are going to cost a lot of 

money. And the VA system is under a lot of pressure. They don't 

have enough money to do what they are doing now. I think to some 

extent, you have the same thing happening in the regular health 

care system where it is driven by costs, it is not driven by safety. 

Dr. LEAPE. Right. 

Mr. PETERSON. And what you are suggesting is going to cost 

more money. If you are going to tell people they can't work 80 

hours, they can only work 40 like an airline pilot-and I am totally 

persuaded computerizing records, bar coding would save a significant number of errors-that is going to cost money. 

I assume Dr. Kizer is going to tell us that they don't have the 

money to do that, to the extent because they can't take care of the 

patients they have. I would imagine you have people in the regular 

health care system that are not doing it because of the same reasons, am I right or wrong on that? Have you studied that whole 

aspect of this? 

Dr. LEAPE. Two answers, one theory and one reality. In theory, 

quality pays. That is, most studies done in the past show improving quality cuts cost. 

Mr. PETERSON. It costs more money at the beginning--

Dr. LEAPE. It costs less money to make a perfect car than to 

make one with defects and have to redo it. 

Mr. PETERSON. But how do you get there? 

Dr. LEAPE. Yes, right, in general. Now, specifically, I will give 

you one example. The Brigham and Women's Hospital recently put 

in a computerized physician order entry system, all orders have to 

be put in the computer. By doing that, it looks as if we have reduced adverse drug events by a sizable percentage, probably as 

much aE 40 percent. 

Every preventable adverse drug event in that hospital costs 

$4,685 to the hospital. The hospital is spending $2.8 million a year 

by our estimate on preventable adverse drug events. If we cut that 

in half, they will save $1.4 million a year, that's every year. That 
19 

will pay for a lot of computers. That may be more dramatic than 

most. Putting bar coding in would certainly save money, because 

if you eliminated 100 adverse events a year because it was the 

wrong dose and so forth. The business about reducing hours is a 

little stickier. 

People are getting paid by the hour, the nurses and pharmacists 

are. The house officers are not, but nurses working double shifts 

get double pay. In fact, they get more than double pay, so it isn't 

necessarily more expensive. I think it is up front going to be more 

expensive, but in the end it will save money. 

Mr. PETERSON. Well, if it is saving all this money, why isn't everybody doing it? 

Dr. LEAPE. Well, they haven't known about it. It hasn't been selfevident up until now. I mean, computerized entries are a new thing 

just coming down the line. 

Mr. PETERSON. Are you kidding me? 

Mr. LEAPE. No, I'm not kidding you. 

Mr. PETERSON. I was in the hospital in my District 5 or 6 years 

ago and I think some of the people in the hospital understood if 

they could computerize, they would save a lot of money. They 

couldn't get their people running the hospital to do it. 

Dr. LEAPE. Yes. 

Mr. PETERSON. So it is hard for me to believe the whole industry 

didn't know about this, about bar coding. Bar coding has been 

around for 15 years. 

Dr. LEAPE. It is hard to believe, isn't it? I am with you. I mean, 

seriously, why haven't they done it yet? 

Mr. PETERSON. And I would guess, there is no money in the VA 

budget to bar code every VA hospital, to computerize every VA hospital so they can have an order entry system. I am totally convinced if we did that, it would save us money, probably a lot of 

money and a lot of problems. 

Dr. LEAPE. Well, see, in the private sector, it is the patients who 

have been paying, you know. 

Mr. PETERSON. Well, the patients have no idea what they are 

paying for. That is part of the problem, and the media is part of 

the problem with this, too. They don't put the right message out 

about what is going on with it. 

Dr. LEAPE. The other answer to your question is if it costs more, 

so be it. 

Mr. PETERSON. I agree. 

Dr. LEAPE. I mean, we are talking about lives. If it is going to 

cost us a little more to do it safe, we have to pay a little more to 

do it safe. You wouldn't begrudge the airlines increasing the price 

of your ticket by 20 percent if it reduced your chances of having 

a crash. It is the same thing here. I really believe that in the long 

run it will save money. All the evidence from industry indicates 

that. But if it costs more up front, then we should pay that. 

Mr. PETERSON. I totally agree with you, but the reaction out of 

Congress might be, because of the media, to put more regulation 

on, to punish people more, which would have the exact opposite 

effect. 
20 

Dr. LEAPE. We are starting to turn that around this morning. It 

is time to change and it starts in one room on one day and then 

it goes on. 

Mr. PETERSON. Amen. You need to go to talk to the appropriators 

I think, too. 

Dr. LEAPE. I appreciate your help. 

Mr. STEARNS. Dr. Leape, before you go, the staff pointed out to 

me there is a provision in VA law that the VA hospitals, in fact, 

have to compensate when an event occurs not reasonably foreseeable. Disability or death caused by hospital care, including carelessness, negligence, and lack of proper skill and error. 

Dr. LEAPE. Well, see, you are ahead of all the rest. You are already a leader. 

Mr. STEARNS. Before you go, you cite one in 200. But then you 

go on to say that doctors don't want to report their errors. Nurses 

don't want to report it. No one ever tells the patient, but in the airline industry we get good reporting. In all candidness, is this one 

in 200, maybe it is 1 in 100 or 1 in 70. How do we have any confidence in this 1 in 200 when we have doctors not reporting, nurses 

not reporting, no one across the hospital industry looking at the 

baseline information? I mean, how do we have any confidence in 

this? 

Dr. LEAPE. I am going to make it worse. That number came from 

our study which was a review of medical records. Every doctor 

knows-every doctor and nurse knows what is not in medical 

records. 

Mr. STEARNS. So medical records have really already been diluted. 

Dr. LEAPE. What I am saying is when we say it is one million 

and 120,000 deaths, that is based on data from medical records. 

The number is almost certainly higher than that, maybe two or 

three times as high. I don't think we need to get everybody all 

shook up, but I think it is clearly a lower bound. It is clearly worse 

than that. 

Mr. STEARNS. But you are just saying for the record, you said two 

or three times so if I took three into 200, I am at 70, so 1 in 70 

is probably a limit you are indicating for the record. 

Dr. LEAPE. It might be. I mean, we don't have that kind of data, 

but it certainly might be. 

Mr. STEARNS. Okay. Well, I thank you for your time. 

Mr. GUTIERREZ. Mr. Chairman, I ask unanimous consent that the 

Members be allowed to submit follow-up questions and responses 

for the hearing record. 

Mr. STEARNS. Without objection. We thank you for your time and 

we will now hear from the second panel. We have Dr. Kizer, Under 

Secretary for Health, Department of Veterans Affairs, accompanied 

by Dr. Wilson, Director, Office of Performance and Quality Department of Veterans Affairs, Dr. McManus, Medical Inspector, Office 

of Medical Inspector, Department of Veterans Affairs; Dr. Mather, 

Assistant Inspector General for Health Care Inspections, Office of 

the Inspector General, Department of Veterans Affairs. 

Let me again welcome our panelists and particularly Dr. Kizer 

for his valuable time and for coming here this morning and we 

await your opening statements. 
21 

STATEMENTS OF KENNETH W. KIZER, M.D., M.P.H., UNDER 

SECRETARY FOR HEALTH, DEPARTMENT OF VETERANS AFFAIRS ACCOMPANIED BY NANCY wn.SON, M.D., M.P.H., DIRECTOR, OFFICE OF PERFORMANCE AND QUALITY, DEPARTMENT OF VETERANS AFFAIRS; JAMES MCMANUS, M.D., MEDICAL INSPECTOR, OFFICE OF MEDICAL INSPECTOR, DEPARTMENT OF VETERANS AFFAIRS; JOHN MATHER, M.D., ASSISTANT INSPECTOR GENERAL FOR HEALTH CARE INSPECTIONS, OFFICE OF THE INSPECTOR GENERAL, DEPARTMENT 

OF VETERANS AFFAIRS 

STATEMENT KENNETH W. KIZER., M.D., M.P.H. 

Dr. KIZER. Good morning, Mr. Chairman, members of the subcommittee. You have my written statement. I am not going to repeat that now. Instead, in the interest of time, I would like to take 

these few minutes to make just five points. First, I hope that Dr. 

Leape's comments made clear that the problem of adverse events 

resulting from medical treatment is a problem affecting health care 

everywhere, public and private hospitals, nursing homes, clinics, 

doctors' offices throughout the country. 

The size and dimensions of the problem are far greater than commonly realized. Indeed, investigators in this area have repeatedly 

stated that the statistics arising out of studies probably indicate 

only the lower bounds of the problem; that is, it is a problem much 

larger than the chilling numbers cited by the Chairman and Mr. 

Bilirakis earlier and those which Dr. Leape noted. 

The second point I would make is that as a former regulator of 

over 5,000 health care facilities in the State of California for quite 

a few years; as a physician who has practiced in a number of settings, ranging the gamut from university teaching hospitals to 

small rural hospitals; and as a consultant on quality of care issues, 

I can tell you, without any question, that the type of medical treatment problems seen in the VA are the same types of problems that 

occur every day in non-VA facilities throughout the Nation. 

The major difference is that these problems elsewhere rarely receive the public scrutiny that events in the VA do. 

Third, while the quality of care provided by the veterans health 

care system overall is as good, and often better, than that provided 

in the private sector, as attested to by various objective indices, the 

system is far from perfect, and the quality of care is not as uniform 

throughout the system as it should be. 

We truly regret that treatment mistakes and some tragic errors 

have occurred. I personally consider even one death or injury resulting from medical treatment to be too many, and I concur with 

the Chairman, or at least with the statement that is attributed to 

the Chairman in the media, that the VA is and should be held to 

a higher standard than the private sector. 

The fourth point is that as part of the veterans health care system reengineering effort that we have discussed before this committee and other committees on a number of occasions, we have implemented a very comprehensive quality care framework, one element of which is a new risk management policy that will routinely 

identify and analyze adverse events that may be related to medical 

care. 
22 

Our approach to this has been reviewed oy a variety of entities, 

and we have gone to other health care systems to seek their critique and input on this policy, and I can tell you they have been 

uniformly very complimentary. In fact, to date, we have not been 

able to identify any other health care system in the country that 

is taking as rigorous approach to ferreting out this information as 

the VA is in its new policy. 

I should note, though, that as we actively seek out these problems in the months and years ahead, I would not be surprised to 

see the number of identified untoward incidents grow; in fact, that 

is something we should expect to see. 

The last point I would make, and as will be discussed by the 

third panel in more detail, I believe VA hospitals have generally 

done a good job of analyzing and correcting facility specific circumstances that may have contributed to untoward treatment-related outcomes. However, VA has done less well in taking those individual lessons learned and generalizing the findings to the system overall; that is, in fact, a focus of much of our efforts at 

present and underlies much of the thinking behind the new risk 

management policy. I can cite perhaps a couple of examples of how 

we are trying to approach this. 

In the last 3 years, we have had three deaths due to errors in 

blood transfusions. We are now moving forward with a bar coding 

system that will be used when any blood transfusion or blood product is to be given. I think Mr. Peterson asked about the cost of 

that. Part of any of these things we talk about doing is what it 

costs for one facility, and then we have to look at the entire system. 

We think this particular intervention will cost about a half a million dollars, of which, I believe, we can readily absorb. We have to 

write some software programs and other things to incorporate it 

into the system, but that is moving forward. 

As another example in a similar vein, we have had an institution 

who has been looking at bar coding for pharmaceuticals or the administration of drugs. We are now looking at this for the implications, fiscal and otherwise, for system-wide implementation. When 

we flush that out we will be either moving forward with it or coming back and seeking funds to implement it. We are hopeful we can 

do it with the savings that we are generating by doing other things 

within the system. Let me stop here. 

I would just conclude by saying that I think we have set the 

stage for changing the way that we do business, and I think this 

will have a salutary effect on the way health care is provided 

throughout the entire Nation. I would say, though, that, frankly, 

we need your help. 

We need a change in the atmosphere and the environment in 

which these things are approached, as Dr. Leape spoke so eloquently about. We welcome your oversight, and we enlist your assistance in trying to solve this very major national problem. That 

is by no means solely a VA problem. It is a problem affecting 

health care everywhere in this country. 

[The prepared statement of Dr. Kizer appears on p. 107.] 

Mr. STEARNS. Dr. Mather. 
23 

STATEMENT OF JOHN MATHER, M.D. 

Dr. MATHER. Good morning, Mr. Chairman. I appreciate this opportunity to appear before you today and discuss VA's policy and 

performance in the area of risk management and also the role of 

the Office of Medical Inspector. With your permission, Mr. Chairman, I request my written prepared statement be entered into the 

record and I will use this opportunity to summarize key issues. 

Mr. STEARNS. Without objection. 

Dr. MATHER. Veterans receiving their medical care through the 

VA can expect the health care professionals who treat them to do 

it well without inflicting serious harm. Even so, over the past 5 

years, there have been instances where this has not been so and 

there have been a dozen or so widely publicized and apparently 

avoidable deaths. 

The Veterans Health Administration, with its system of medical 

centers, has long had policies which were intended to minimize 

risks to their patients of inadvertent error in medical care. Actions 

have been taken which, if consistently and properly applied, would 

have prevented serious disability and deaths under unusual or apparently avoidable circumstances. 

The risk management policy focused on achieving effective VA 

medical center programs, with appropriate oversight by regional 

networks offices (the VISNs), and headquarters offices including 

the Inspector General. Over the past several years, whenever there 

have been incidents of serious disability and avoidable deaths 

under unusual adverse circumstances, VA medical centers have 

taken the situations very seriously. Their staffs have conducted indepth investigations, determined the nature of the error, assigned 

individual culpability, devised mechanisms to prevent similar incidents and filed reports with senior management. 

Over the past 5 years, the VA has issued a series of policy directives on risk management. It has recently published a strong and 

comprehensive risk management policy. This latest directive fully 

addresses the criticisms we have previously raised concerning omissions and weaknesses. The present policy has the potential for significantly strengthening the VA's present procedures and mechanisms for coordinating an effective risk management program. 

VA's risk management policies have always had reporting requirements for the VA medical centers with defined procedures for 

oversight by regional components (the VISNs), and headquarters. 

Over the past couple of years, it seems that issues related to resource allocation, strategic planning and the implementation of a 

performance measurement system have been dominant on their 

agendas. Consequently, components in Central Office have not 

given careful attention to reviewing aggregate information on adverse events. This new risk management policy seeks to remedy 

this deficiency by assigning more definitive roles to VISN s and 

Central Offices. 

Eventually, throughout the VA's health care system, the information on adverse events can be appropriately standardized to insure 

that comparable data and information are collected and available 

for review. In this regard, the risk management directive gives 

broad guidance and each VISN is required to appoint a statistical 

consultant who can provide some consistency. Once data and infor-
24 

mation on risk management are collected, it is essential that it be 

tracked and regularly examined for trends. This requires assignment of clear roles and responsibility in the VISNs and for Central 

Office components. 

Here, the new policy provides the specific guidance for the organization of an Adverse Events Registry and the establishment of a 

Central Office Risk Management Oversight committee. The VA's 

Medical Inspector is a member of the committee, but his participation is likely to be compromised as long as questions persist about 

the role and staffing of the Office of the Medical Inspector. 

The Risk Management Oversight Committee needs to regularly 

review the Adverse Events Registry and identify relevant information for prompt dissemination to VA medical centers. This communication is an essential feature of a risk management policy for a 

health care system as large and complex as the Veterans Health 

Administration. 

My Office of Health Care Inspections is the primary office in the 

Inspector General's office, with direct clinical and quality assurance 

oversight responsibilities. In fulfilling this role, we have generally 

reviewed as paramount the VA's need to revise its risk management policies and significant progress has been made in correcting 

several previously deficient areas. 

My office will continue to actively monitor the implementation 

and effectiveness of these risk management policies. Mr. Chairman, 

this completes my oral testimony. I will be pleased to answer any 

questions or provide written commentary in the future. 

[The prepared statement of Dr. Mather appears on p. 117.] 

Mr. STEARNS. Thank you, Dr. Mather. As I understand, Dr. 

Kizer, those are the two only opening statements, or are there additional? 

Mr. KIZER. No sir. 

Mr. STEARNS. Okay. I think the big question I have is, how big 

a problem is safety with the veterans' hospitals? You are quoted, 

again, in the Washington Post saying, quote, "we really do not 

know the complete dimensions of what we are dealing with." You 

know, that is a very candid statement, and I commend you for 

what you are doing here in issuing a new directive and, as you 

pointed out in the press, your joint effort to improve hospital care 

and get an understanding of the safety. 

But, Dr. Kizer, until we made a request to see the systemwide 

patient incident reports, that data had not been systematically reviewed for several years, and as I understand, this is contrary to 

your own policy directive of April of 1995, chapter 35, of VA manual M-2. I guess the first question is how do you explain that, and 

how do we know it is going to occur after your new directive? 

Dr. KIZER. I think there are probably a lot of things that can be 

said on why it was not occurring. I would just sum it up by saying 

some things that I had thought were being done were not being 

done. I think the focus and the attention has significantly changed, 

and I know that one of the reasons why you can have confidence 

that things will change is because you are going to ensure that 

they do, in addition to our efforts. 

But I think within the organization there is now a commitment 

to our risk management progress. As Dr. Leape alluded to, much 
25 

of the problem here is a cultural problem in medicine, and medicine everywhere, as far as a willingness to identify and openly talk 

about and thoughtfully analyze errors and mistakes that occursome of which are preventable, some of which may not be. VA 

health care practitioners are like what you would find elsewhere in 

that there is often a reluctance to do that, either because of fear 

of litigation or other concerns, because of the way things typically 

get sensationalized in the media with anecdotes getting blown out 

of proportion, and a whole host of other things. The bottom line is 

there have been changes put in place, and they are going to be carried through on. 

Mr. STEARNS. You know, when I heard Dr. Leape talk about 

underreporting, it comes to my mind the staff has shown me statistics that the number of reported incidents in 1994 were 5,063; and 

in 1996, it was 3,622; and this year the number of incidents is 

shrinking further. I mean, I don't know, but just looking at that 

report makes you concerned. 

Then when you go to look at the patient incident reports at particular networks, through 1997, mid-September, there are some 

very low numbers here. Some are reporting 13 incidents, 15,21. So, 

I mean, this would sort of corroborate what you have been saying 

and what Dr. Leape has been saying. I mean, I would suspect, 

there seems to be underreporting from the data we have here. 

Do you want to comment on the fact that there appears, from the 

data here, that things are going down, and that the different networks are reporting very, very small incidents, and based upon 

what we have heard from Dr. Leape, it gives you a question of 

underreporting? 

Dr. KIZER. I think you are absolutely correct; that is a very legitimate question. It is one that we are looking at as well. The nonuniformity of this across the system is certainly one that we are looking at to see if we can better explain it. 

The nature of the drop in reported incidents may well be due to 

underreporting. It may well be due to other things as well, including shorter hospital stays and the shift in care to outpatient settings. We have other data, for example, that shows significant improvements in care. For example, 3 years ago, we began tracking 

specific types of patients-Le., specific vulnerable cohorts of patients-and looking at their longevity and clinical outcomes; we 

now see that over that period of time, there have been statistically 

significant increases and improvements in their I-year survival 

rates. 

There are some other indicators that also would suggest that the 

quality of care is improving. For example, in surgery the numbers 

show fewer deaths and complications related to surgery. So at this 

point, I think underreporting is certainly a potential problem and 

may well account for some or indeed much of lower counts. But we 

also have data that suggests that quality of care is improving, and 

the actual numbers of complications are dropping. 

I am not going to stand before you and say that it is one or the 

other. I think we need to continue to look at this. I also would note 

that no matter how much we look at what has happened historically, we will probably never be able to ferret it out completely. 

What we are trying to focus on is where we go from here and how 
26 

we move forward and get the sort of baseline data and ongoing 

mechanisms in place that can answer the questions you have, and 

also provide our patients with the sorts of assurances they need, 

and how we can demonstrate leadership to the rest of the health 

care community. 

Mr. STEARNS. I think that is good. And you are pointing out, as 

Mr. Bilirakis pointed out, about setting the culture. 

Let me just suggest or comment that your new policy, as I understand it, calls for a headquarters committee meeting once monthly 

to review all adverse events and all Board of Investigation reports. 

Now, considering there are thousands of cases, and you have this 

backlog of information, doesn't the headquarters committee have a 

responsibility to meet daily to look at this, rather than monthly, to 

carry out this responsibility, particularly in light of the fact that 

what appears here, we have all the information collecting, we are 

not doing anything with it, it seems to me you should jump on this 

and do it daily. Am I wrong? 

Dr. KIZER. The frequency of review is certainly not set in stone, 

and if it turns out we need to meet weekly, biweekly, daily, then 

will do so. These are all things that as we move forward with implementing this policy, are subject to change, according to what the 

data and our results show. 

Mr. STEARNS. My last question is for Dr. Mather. Would you 

elaborate on the concern you have expressed in your testimony, 

and we sent out the letters to all the administrators of the hospital, 

as a result of the articles that were in Congressman Bilirakis' congressional district. We read these articles, and we were concerned, 

just as he was. And then we sent these letters to all the administrators, and they came back, and you, as I understand it, looked 

at these letters. 

The VA's new risk management efforts-let me just read it to be 

very clear. Would you elaborate on the concern expressed in your 

testimony that VA's new risk management efforts may be compromised to the extent that its Medical Inspector's Office is understaffed; that is the key, is it understaffed. 

Dr. MATHER. Mr. Chairman, in the Under Secretary's written 

statement, and also in mine, there is an elaboration there of some 

of the roles that have been performed by the Office of the Medical 

Inspector over the past few years. I know Dr. Kizer has a contract 

to review that role and function, which he anticipates will be completed later this year. 

If you look at this risk management policy, there is clearly a very 

key role for the Medical Inspector, Dr. McManus, to perform. Not 

only is it the receipt and review of those Boards of Investigation 

and the focus reviews, but to be very much of an active participant 

in that particular oversight committee, the Risk Management Committee. I think it is a dilemma he has, and that is while all the 

scopes of responsibilities he has, his staff over the last 3 years is 

down under half what it was. He did have a staff of some 20, and 

with what I see as the scope of what Dr. Kizer has in mind for that 

office, I do not see how Dr. McManus, with his small staff, and also 

with, generally speaking, a nonclinical staff, has really the wherewithal to be a complete and active participant in that oversight 

committee, the Risk Management Oversight Committee. 
27 

Mr. STEARNS. Thank you. Mr. Gutierrez. 

Mr. GUTIERREZ. Thank you very much, Mr. Chairman. 

Welcome to the panel. Welcome, Dr. Kizer. I guess we have a 

great opportunity for the VA to set a standard for the rest of the 

Nation, and I guess-I don't guess, I know that apart from your 

comment, Dr. Kizer, that this committee won't allow it to happen, 

I think we also have a responsibility to deal with everybody at the 

VA to ensure that you have the resources. 

So we would also like to hear, if you are going to issue a report 

back to us and you are going to be communicating to us, I think 

that is just as important as everything you are doing is everything 

you need to get it done so that the Members can be fully aware so 

that in the future, I think it is very fair for someone to be able to 

say, well-for me to be able to add, well, Dr. Kizer, you know, this 

is what you did; and for you to be able to say, yes, this is what 

I asked you in order to get there. And I think if we are going to 

do that, I certainly would like to have a complete list of the things 

you need to get it done. 

Having said that, if you could just share, Dr. Kizer, with us some 

specifics and reiterate just exactly what you intend to do, but not 

in general terms, but in specific terms. What can we expect to happen at VA hospitals that they are going to make the system better? 

Dr. KIZER. I think what you can expect is that as we analyze 

these incidents, we will be looking at all of them for systemwide 

improvements, and what you will see is a succession of systemwide 

implementations of interventions that are identified at the local 

level as being successful. Patient identification by bar coding, in 

the case of blood transfusions, is one example. Bar coding for pharmaceuticals is another. 

But as these are identified, the focus here is how can we implement those from a systemwide perspective. I wouldn't be surprised 

if there were resource needs associated with these interventions as 

we move forward. And as the committee knows, because of budgetary reductions, our headquarters operation has been reduced by 

about 30 percent of its staff in the last 3 years. As we have tried 

to look at the staffing needs for the Office of the Medical Inspector, 

that has to be done within the context of overall, very substantial 

reductions that we are forced to live with, in addition to some particular issues regarding the overlap in law, as well as in policy and 

operations, of the Office of the Medical Inspector and the Office of 

Health Care Inspections within the Inspector General's Office. As 

was commented on, or has been identified in other sources, there 

is overlap there, and that results in some confusion as far as exactly who is responsible for what. 

We have also-as Dr. Mather noted-hired a consultant to review the functions of this office because this is unique; there is no 

such entity as the Office of Medical Inspections elsewhere in the 

health care system. That function simply doesn't exist anywhere in 

the private sector, and there are notable differences between how 

that office has operated in the past in the VA, as opposed to the 

Department of Defense, where there is an analogous office. To help 

with that, we have contracted with a consulting group to try to 

help ferret out some of those things. We have some preliminary information, and we expect to have their final report within the next 
28 

couple months. Based on that, we will be looking at what the staffing needs may be for that department. 

But I would also add, as I have reiterated to Dr. McManus on 

a number of occasions, that while his office may have only a certain 

number of people, there are approximately 15,000 physicians in the 

system that are at his disposal should he need them; there are tens 

of thousands of nurses and other personnel. All he has to do is tell 

me what type of person he needs, and we will make those available 

to his office to conduct reviews or inspections, as needed. 

Mr. GUTIERREZ. Thank you very much, Dr. Kizer. 

Thank you, Mr. Chairman. 

Mr. STEARNS. Mr. Bilirakis. 

Mr. BILlRAKIS. Thank you very much, Mr. Chairman. 

A lot has been made of the underreported adverse incidents, and 

we can't belittle that. Because if we don't know what the problems 

are and we don't know what the occurrences are. How in the world 

are we even going to possibly try to address them and to solve 

them? 

One of you, it might have been Dr. Mather, I am not sure, said 

something about we need your help. Exact three words: We need 

your help. I guess Dr. Kizer said it. And I think that is good. Although, unless you tell us what you want us to do, I mean, other 

than more money, I am not sure that we can help, and I would 

hope that more would come from you all here today in that regard. 

But let me go to a couple specifics here, because this cultural 

thing is very important, and we talked a lot about it, if you recall, 

when we had the sexual harassment hearings surface. There is a 

culture there. There is an accusation of good old boys culture and 

culture at the VA, and it is just very important. 

I am going to refer to a June 15 article in the St. Petersburg 

Times and ask two questions regarding that article. The Times reported the VA was forced to rehire a doctor that an assistant U.S. 

attorney called, "a menace to his patients' well-being." This doctor, 

who worked at the Beckley, WV, VA Medical Center had four malpractice complaints against him and eventually had his license suspended by the West Virginia Board of Medicine. His license was 

formally revoked in January of 1997. And the article also went on 

to report that one VA physician had to take the medical examination 10 times, 10 times before passing. 

So the questions are, first, how big of an impairment is this for 

you as you try to effectively manage the VA health care system? 

Dr. KIZER. Let me say two things. First, you cited a couple of instances, and just should the people sitting immediately behind me 

generalize that to the rest of the physicians in the VA, I would note 

that 70 eercent of physicians in the VA are university faculty, and 

you won t find that at any other health care system in the country. 

These are what we generally consider the best physicians in the 

country. 

Mr. BILIRAKIS. But we want as close to 100 percent as we can 

get, don't we, Dr. Kizer? I don't think we should be sitting on 70 

percent. I mean, it is a good statistic, and I appreciate that. 

Dr. KIZER. Seventy percent are university faculty, and you are 

mixing two things there. The point, or specifically the point you 

raise, and I will respond to it the way I responded at a number of 
29 

other hearings and settings as well, whether it is sexual harassment or whether it is some of the issues related to how we deal 

with physicians who we would like to-or other professionals we 

feel aren't serving the system well, the civil service laws and rules 

are a major impediment. I understand they are well-intended and 

that they are certainly derived by good motivations, but the person- nel system has become so complex and so difficult and unworkable 

that it is creating many of the problems that you are now focusing 

on. 

Mr. BILlRAKIS. You are attributing some of the problems to the 

fact that you can't fire, let go, or maybe in another way reprimand 

a Federal employee because he or she is a Federal employee. 

Dr. KIZER. There are so many levels of appeal and other mechanisms to circumvent disciplinary action that the system is exceedingly difficult to work with. The case you cited is one particularly 

egregious example of that where we tried to terminate the person, 

but the system forced us to rehire the individual. 

Mr. BILIRAKIS. All right. But have you come to the Congress, or 

has anyone at the VA come to the Congress and said to the Congress, look, you know, the laws mean well, we don't want to hurt 

innocent people, et cetera, but these are some changes that we recommend to allow us to be able to serve the veterans better? 

Dr. KIZER. We have discussed this, I would say, informally. But 

if I could take that as an invitation, we will come back with some 

more specifics. 

Mr. BILlRAKIS. Sure, you can take it as an invitation. I can't really speak for the committee, although the chairman is shaking his 

head yes. 

Mr. STEARNS. I agree completely. 

Mr. BILlRAKIS. Then it goes on to what type of standards does 

VA have for hiring of physicians and other medical personnel. Now, 

why would this physician who had to take the medical examination 

10 times before passing have been hired by the VA? 

Dr. KIZER. If he is a licensed physician, the law doesn't allow us 

to discriminate against him because he had to take it 10 times. 

Once he passed and was licensed, by statute we cannot discriminate. 

Mr. BILIRAKIS. But you don't have to take everybody who applies, 

do you, just because they happen to be a licensed physician, and 

there happens to be an opening? I mean, isn't there some criteria 

there, whether it be subjective or otherwise, which allows you to 

not hire this one individual because the person might have something wrong with him or whatever the case might be? 

Dr. KIZER. Well, I think it is not that simple. 

Mr. BILIRAKIS. It isn't? 

Dr. KIZER. No, it is not. We would certainly be willing to engage 

in further discussions on specifics. 

Mr. BILIRAKIS. I know this is a public hearing, and there might 

be sensitivity to some things that might be said and all that, but 

darn it, we are talking here about veterans. You know how I feel 

about the veterans health care system, but problems are there, and 

we can say that those problems are no worse there than they are 

in the regular health care system in America or maybe in the 

world. That doesn't make any of us feel any better because we are 
30 

talking about treating veterans, who are ..,;pecial people. And so it 

seems like we ought to be confronting some of these things head 

on, because when we are talking about culture and cultural 

changes, I think these things are part of all that. 

Dr. KIZER. And I agree. 

Mr. BILIRAKIS. And there is something in the law that precludes 

you from being able to make a decision when more than one person 

applies for a job that you take this person versus the other person 

or whatever; is that right? 

Dr. KIZER. Without being able to focus on the specific circumstances, it is pretty hard to talk about that in the abstract. All 

I can-I would go back that the prohibitions against discriminating 

against somebody are very strong and very explicit in the law. 

Mr. BILIRAKIS. But, sir, excuse me, forgive me, Doctor-Mr. 

Chairman, with your indulgence-but you use the word "discriminating." I am talking about making a decision. I mean, you know, 

we are human beings, and when we hire people, I don't think we 

should be discriminating. Are we saying that this particular individual had to take the examination 10 times, it would have been 

considered discrimination if we hadn't hired that person? 

Dr. KIZER. It might well have been, yes. That is the nature of the 

law and how it is being interpreted. 

Mr. BILIRAKIS. So if I am not hired, the law will protect me in 

terms of they can say, hey, they don't like Greeks, or something of 

that nature; is that right? 

Ms. WILSON. Or someone with an anxiety disorder, and the reason they took the test 10 times was because of that, we would be 

discriminating against someone with a psychiatric illness. 

Mr. BILIRAKIS. I am sure the veterans love to hear that. 

Dr. KIZER. Well, we don't write the laws, but the way they are 

interpreted in the real world, in interpreting these things, they are 

not always used to the advantage of the employer or in the way 

they were intended; they do not work to the advantage of the system all too often. 

Mr. BILIRAKIS. Thanks, Mr. Chairman. 

Dr. KIZER. I would, if I might, mention one of the new policies 

that we put in effect a few months ago was the requirement that 

any new physician that is hired into the VA system must be board 

certified in the specialty that he or she will be practicing in. While 

this requirement is present in some other health care systems, that 

is not the norm in the community at large. 

Mr. STEARNS. Dr. Cooksey. 

OPENING STATEMENT OF HON. JOHN COOKSEY 

Mr. COOKSEY. Thank you, Mr. Chairman. Well, this, no doubt, is 

a problem, and it is a problem that needs to be addressed. And in 

defense of the VA, the veterans' hospitals have received some cuts, 

I think oftentimes too many cuts will ultimately lead to the reduction in quality of care, because when you cut and cut personnel, it 

is going to create a problem. I happen to personally believe that 

when you have the best physicians, the best health personnel, 

nurses and so forth, you are going to get the best quality of care. 

But too often we make decisions based on the cost of care instead 

of quality of care, and as long as we are making decisions, health 
31 

care decisions, based on cost of care and not quality of care, we are 

not going to get good quality care. 

But in this current climate, these decisions are dictated by politicians, and now that I have changed from being a physician to being 

a politician, I assume I am part of the problem. They are made by 

bureaucrats, they are made by numbers crunchers, and they are influenced by the media and the tort system, which is greatly distorted, and it is a shame. 

And I agree with my colleague, Congressman Bilirakis, that it is 

a shame that physicians who have failed an exam 10 times can be 

brought in, because there are physicians out there. I happen to 

serve on the ethics committee of our State medical board for about 

8 years, and it is the worst job ever-I realize there are people out 

there that probably should not be working, and too often they can 

end up in a State hospital because they have had their license 

jerked, and the only thing they can get is an institutional license, 

which means they can work at a State hospital or a veterans' hospital. I think the veterans deserve better than that. So it is a problem. 

Dr. KIZER. Let me just interject, just to clarify one point. They 

may well be able to work at the State hospital, I can't comment on 

that, since there are 50 different sets of laws dealing with the 

States; but if they have had their license revoked, they cannot 

work in a VA hospital. They have to be licensed to work for the 

VA. 

The other thing I would comment on is your comment about the 

malpractice and tort system in this country being a major barrier 

to addressing this problem of adverse events related to medical 

treatment. It is an absolute major contributing factor to why these 

things aren't talked about openly and why they aren't dealt with 

in health care overall. 

Mr. COOKSEY. Sure, no question about it. But, unfortunately, the 

trial lawyers carry the day. In case you didn't know, Dr. Kizer, I 

am sure you know this, there are 172 lawyers in Congress, and I 

think 52 or 53 in the Senate, and that is part of the problem, and 

there are too many in State legislatures. But anyway, I am obviously biased, and I do discriminate against trial lawyers and relish 

it. 

But, you know, I think we are all here to make sure we get the 

right health care for veterans because there are good veterans out 

there. I had a retired physician, a veteran, World War II, good guy, 

tell me about some concerns at a local veterans' hospital in my District, and we checked it out, and there really was some misinformation there. There is still a lot of misinformation and this particular 

veterans' hospital is doing top quality work with good physicians, 

and I am pleased to be affiliated with it. There is another veterans' 

hospital in the general area that perhaps does not-has not addressed all these problems, but it does get back to quality of care, 

and that is what I think we are all about. And I applaud your efforts in moving in the right direction. 

And this is the type of flowchart that you need to find these 

problems, and it is one we deal with in the private sector as well, 

but we can do it-these problems will best be solved by properly 

motivated health personnel making the decisions, instead of politi-
32 

cians, lawyers, and the media trying to make these decisions or influence these decisions to their own advantage. 

Thank you, Mr. Chairman. 

Dr. KIZER. If I can make one final comment, please. One of the 

ways you can help is exactly what Dr. Leape mentioned as far as 

the climate and how these issues are perceived. There was an excellent article in the New York Times a few months ago about the 

need to change the mindset around this problem; it specifically 

dealt with medical treatment errors in private institutions. Insofar 

as starting at the top, the culture can change to facilitate open and 

thoughtful discussion of these things, and anything Congress can 

do in that regard certainly would be beneficial and would translate 

probably very tangibly into ultimately better care for our veterans. 

Mr. STEARNS. Let me just thank you for your candidness, and towards this idea of the culture that we want to improve the system, 

may I suggest, and we would welcome, if you would follow up, perhaps, with suggestions for us to improve the selection, the management of these facilities, because in the end, if we could together 

work to do that, we would provide immeasurable benefit to the veterans in this country. 

The last sort of question I have is when it is all said and done, 

what will this committee get from your Department in the way of 

records showing that you have increased effectiveness, you have determined that these records are not underreported, and so forth 

and so on? So I am just asking you as a management policy, what 

will this committee see from your Department? 

Dr. KIZER. Obviously, in general terms, you will see whatever 

you want, whatever we can provide, and if the information that we 

do provide you as far as the statistics and numbers and the specific 

examples of things that have changed is not adequate, then we will 

increase that to give you, the committee and the Congress a level 

of comfort that it needs to be confident that the problem is being 

addressed and that improvements are being made. 

Mr. STEARNS. Again, I want to thank all of you. 

Mr. KENNEDY. Mr. Chairman, can I just make one point? 

Mr. STEARNS. Absolutely, Mr. Kennedy. 

OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, II 

Mr. KENNEDY. I apologize, Dr. Kizer, and other members of the 

panel for being late. I had, as you know, another conflict up here 

at the same time. 

But I just wondered if you might comment generally, Dr. Kizer. 

I think that the fear that people have, generally speaking, after a 

movie a couple years ago, I think it was called Article 99, that sort 

of demonstrated, you know, kind of a cannibalistic health care system within the VA, where parts of the VA health delivery system 

had to be robbing from other parts in order to be able to provide 

any kind of reasonable amount of care. And the real concern, I 

think, goes back to hearings that we have had in this committee 

room over the course of the last several years, where we have had, 

for instance, VA directors come before us, tell us everything was in 

fine shape within their own regions, and then I have walked out 

the door and had a VA director grab me and say, listen, I can't, 

in fact, tell you the truth within that committee because it will 
33 

mean my job, but the truth of the matter is that underneath we 

are really in trouble in terms of having enough money to be able 

to actually create the kind of health care system that will provide 

the basic protections. 

I apologize for missing your testimony, but do you have concerns 

that you just don't have enough resources to actually get the job 

done to be able to provide the kinds of assurances that you would 

actually see within the private health care system? 

Dr. KIZER. Let me just say, on the movie, that I have heard of 

it, but I have never seen it. 

Mr. KENNEDY. You got to catch it. It is worth the rental. 

Dr. KIZER. I have heard contrary views. 

Mr. KENNEDY. I am sure where you work you have. 

Dr. KIZER. Resources are always an issue. I think that many of 

the changes we are putting in place, as we have discussed at other 

hearings, are showing that we can take the limited and constrained 

resources that we do have and make them go a lot further. We 

really are able to do this; this year we have treated more veterans 

than have ever been treated in the VA before, and we are able to 

show very tangibly that'$e quality is better. 

Are there issues? Yes. And we are going to have to continue to 

focus on those. \ 

Mr. KENNEDY. All right. Bht I guess what I am really trying to 

deal with is-I understand that, and I think everybody gives you 

great high marks for revamping the VA health care system and 

kind of bringing it into the 21st century. But I am asking a slightly 

different question, and I am making a different point. 

There have been a number of instances where there-and these 

are always pointed out to be individual circumstances-where bodies have been found in hallways, where they were-where body 

parts, I believe, were found at a VA health facility in the Midwest, 

out buried in different parts of the facility. In my own district I am 

certainly aware of VA health facilities that were in very, very bad 

condition with plaster falling down into the mouths of dental patients and the like. I mean, these are the kinds of-where an individual had died in a hallway and had been left for a couple of days, 

you know. 

I mean, these are circumstances that could, in fact, be isolated 

incidents. On the other hand, they could be circumstances that portray a pattern that I don't think, you know-the last thing we want 

to do is have you feel defensive about the system and feel that it 

is an automatic response to come in and just say, oh, we are getting better, if, in fact, there is a major problem below that is just 

not getting the kinds of resources that are necessary to deal with 

creating an adequate health care delivery system. 

So I just want to make-I want to make it very clear that nobody, I think, is interested in seeing any kind of whitewash of serious problems that exist because of a lack of resources. If that is an 

issue, I think, you know, we should just know it and understand 

it, rather than just be told that, and have you or anybody else feel 

that this is going to be a reflection on the kinds of changes that 

you have brought about, which I think, as I said earlier, people I 

think are generally very supportive and complimentary to the leadership that you have shown. But I am and have always been con-
34 

cerned that below the surface there is a great deal of need within 

all sorts of the VA health facilities that maybe we just aren't even, 

you know, coming close to the kinds of adequate resources that are 

necessary to deal with the problem. 

Dr. KIZER. Well, you know, I think you cite some specific anecdotal things that hopefully wouldn't be generalized in the system, 

because I don't think they accurately characterize the nature of the 

care, the physical plant or other aspects of the system. 

But I would go back, again, to note that resources certainly are 

and will continue to be an issue. The VA budget over the past 15 

years has gone up each year, generally, 2 or 3 percent. Medicare 

and Medicaid are going up 8, 9, 10 or 12 percent each year. I mean, 

unquestionably the funding support for the veterans health care 

system is not on par and has not kept up with other government 

health care programs as far as the funding they are receiving. 

Mr. KENNEDY. And it is your opinion, then, that that has created 

serious shortfalls in terms of the kind of quality care that is necessary to provide-you know, just the adequate health care to the 

veterans? 

Dr. KIZER. I don't think the funding is at the root of this. I think 

there are other things we have talked about at some length this 

morning that really will help, but I don't think that resources are 

the root cause of the problems that have been cited. 

Mr. KENNEDY. Thank you, Doctor. 

Mr. Chairman, I appreciate your indulgence. 

Mr. STEARNS. Sure. We are going to take a recess now before the 

third panel, which is very important, that is the directors from 

three major hospitals who have answered our request. So the committee is in adjournment until we have two votes, and we should 

be back perhaps in about 15 minutes, or I should be back after the 

two votes in about 15 minutes. 

Dr. KIZER. Mr. Chairman, it was my intent to sit through the 

third panel, but I do have a speaking engagement that I need to 

go to. 

Mr. STEARNS. I understand. Is there anything you would like to 

add before we conclude? 

Dr. KIZER. No, that is fine. 

Mr. STEARNS. Okay. Thank you all for your time. 

[Recess.] 

Mr. STEARNS. The committee will come to order, and we will resume with the third panel: Dr. Elwood Headley, Director of Boston 

VA Medical Center, Department of Veterans Affairs; T.C. Doherty, 

Director, Miami VA Medical Center, Department of Veterans Affairs; and Billy Valentine is Director, Muskogee VA Medical 

Center. 

Gentlemen, I want to thank you for coming, and I know, having 

been in business myself, you have to take time in your busy schedule to come here; so we appreciate your taking your time and sharing with us your opening statements. 

So at this point you can begin. 
35 

STATEMENTS OF ELWOOD HEADLEY, M.D., DIRECTOR, BOSTON VA MEDICAL CENTER; T.C. DOHERTY, DIRECTOR, MIAMI 

VA MEDICAL CENTER, ACCOMPANIED BY DOUGLAS BRADSHAW, ASSISTANT GENERAL COUNSEL; AND BILLY VALENTINE, DIRECTOR, MUSKOGEE VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS 

STATEMENT OF ELWOOD HEADLEY, M.D. 

Dr. HEADLEY. Thank you very much, Mr. Chairman, members of 

the committee, thank you for the opportunity to present the details 

regarding this incident. Written testimony has already been submitted and this will be a brief summary of that testimony. I will 

present the circumstances of the case, the nature and findings of 

the investigations which occurred, and remedial steps which were 

taken. 

The patient was a 60-year-old man with cancer of the esophagus. 

He had previously undergone surgery for this and was taken back 

to the operating room for reexploration of the surgical site and 

drainage of fluid accumulation from the right side of his chest. He 

was seriously ill prior to the surgery and judged to be a high-risk 

surgical candidate. 

During the surgical procedure, he suffered a cardiac arrest and 

attempts at resuscitation were unsuccessful. In the process of reviewing the events surrounding his death, it was discovered that 

he had received two units of packed red cells, typed and crossmatched for another patient. 

Needless to say, the staff was devastated. Fact-finding was 

begun immediately, the patient's family was promptly notified of 

the incident, and of their rights, appropriate internal VA and external notifications were immediately accomplished. An administrative board of investigation was charged to review the incident. And 

if I might just add, a typographical error in the submitted testimony states that the administrative board of investigation was 

begun March 8, 1997, it was 1996; I apologize for that. It was an 

immediate board of investigations. 

Mr. STEARNS. Unanimous consent, so corrected. 

Dr. HEADLEY. Thank you. 

Findings of the board. The identification of the patient prior 

to and during the surgical procedure was an area that was looked 

at. Each discipline in the operating room independently identified 

the patient, but there was no interdisciplinary process in place to 

verify this identification. Another finding was that blood was stored 

in a refrigerator in the operating room by room number, this is a 

relatively standard practice in operating rooms. This patient was 

in operating room number 7. He received the blood prepared for the 

patient who preceded him in operating room number 7. 

The arm band identification of the patient was not verified 

against the blood product prior to administration. This was clearly 

in violation of policy and procedure. 

The conclusion of the administrative board of investigation was 

that the transfusion error had both a human error and a system 

component. Had the verification process included the confirmation 

of patient identification, as reflected on the wrist ID band, the incident could have been avoided. While the transfusion error was the 
36 

result of human error, there were also opportunities to improve 

systems and existing policies and procedures. 

The remedial steps that were taken: In addition to the administrative board of investigations summarized above, a root-cause 

analysis was undertaken of our entire blood administration process. This is a method of reviewing processes as an aid to restructuring them. Based on the findings of the administrative board and 

the root-cause analysis, it was decided to reengineer our blood and 

blood products policies and procedures totally, in order to prevent 

this from ever happening again. 

The following were implemented: Letters of reprimand were issued to the anesthesiologist, the certified nurse anesthetist and the 

nurse involved. There was a total redesign of the process of blood 

administration to assure interdisciplinary verification of patient 

identification prior to the initiation of anesthesia or procedures, 

and prior to the administration of blood or blood products. There 

was a redesign of the process to a uniform system of dispensing 

blood to the operating room by individual patient, rather than in 

bulk, and eliminating storage of blood in the operating room and 

outside of the blood bank, minimizing risk to patients. Blood is now 

individually dispensed to the patient in the operating room, directly from the blood bank. 

There was a change in policy to require documented, informed 

consent for blood transfusion, medical center-wide to facilitate active involvement of patients in the treatment decisionmaking 

process. 

Educational programs addressing all of the above were instituted 

hospital-wide with special emphasis on the operating room. Educational programs on risk management were presented hospitalwide with emphasis on the operating room. 

Ongoing monitoring of all the steps in the blood administration 

process were instituted and are being followed by the transfusion 

committee of the Boston VA. An annual review of blood and blood 

product administration was instituted in the hospital's ongoing 

clinical staff education program. 

The Joint Commission on the Accreditation of Health Care Organizations paid us an unannounced visit for cause to review our 

blood administration program. While we were in compliance with 

their standards at the time of the visit, we were placed on accreditation watch, pending implementation of the recommendations 

from the administrative board and the root-cause analysis. 

We were revisited several months after this initial visit and the 

watch was lifted. We were re-reviewed as a part of the triennial 

survey 3 weeks ago and were found to be in total compliance with 

Joint Commission standards. 

Thank you very much. 

[The prepared statement of Dr. Headley appears on p. 135.] 

Mr. STEARNS. Dr. Headley-I guess we got the name tags mixed 

up. 

Mr. BILIRAKIS. Change around the name plates in front of you. 

Which one is Dr. Headley? 

Mr. STEARNS. Okay. So, Mr. Doherty. 

Mr. DOHERTY. Sorry about that. 

Mr. STEARNS. No problem. 
37 

STATEMENT OF T.e. DOHERTY 

Mr. DOHERTY. Mr. Chairman, members of the subcommittee, you 

have my statement, and if acceptable, I would just like to enter the 

statement into the record and give you a brief statement regarding 

the untimely death of Mr. Martin. 

I would like to say in the beginning, Mr. John Martin was more 

than a patient of ours, he was a personal friend. John came out of 

the military after a very brief stint and became a patient of the VA. 

We cared for him for more than 25 years before his untimely death. 

John was noncompliant, he was in the end stages of renal disease, 

and we did everything humanly possible to encourage him to 

change his dietary and other habits. Prior to John's death, there 

have been no-there had been no adverse effects related to staff 

performance in our dialysis program. 

The Miami VA Medical Center instituted the first dialysis treatment program in 1966. There were more than 135,000 treatments 

provided our veterans and, absolutely, this was the first untoward 

incident that had occurred. Mr. Martin's death was because the dialysis nurse, who had cared for him for a number of years and who 

was an experienced nurse, 16 years service, connected Mr. Martin 

to the dialysis machine, and she failed to connect the venous dialysis line to the return port. Instead, the line was left and his blood 

went into a container. This resulted in a loss of more than 1,800 

cc's of blood. 

A brief overview of the events is as follows: As the dialysis nurse 

began the dialysis connection process for Mr. Martin, she encountered a problem with the venous transducer, which is a center unit 

that indicates blood pressure; she was unable to correct the problem and she called the nurse, a dialysis technician. While they 

were working, the dialysis nurse, his principal nurse, was called to 

the telephone. The dialysis technician continued to troubleshoot the 

transducer and the machine and determined the transducer needed 

to be replaced. 

After she replaced the transducer, the technician proceeded to 

leave the patient's bedside. At this point, she heard the hissing of 

blood going out of his body. 

The dialysis nurse returned-she was on the phone for approximately 2 minutes-she and the technician immediately began to 

replace the blood that had been lost by Mr. Martin with large 

amounts of saline solution. The technician also began to clean up 

the blood spill. In the process of cleaning up, the technician showed 

a second dialysis nurse the amount of blood that had been spilled. 

The second nurse then began to assist with Mr. Martin's care. 

He appeared to stabilize, he spoke to the nurse, he spoke to the 

dialysis technician, but shortly after, his stability began to deteriorate, and an emergency code was called. The code team responded 

promptly. The team, however, was not informed of the blood loss; 

instead they were told the patient had developed abdominal pain 

followed by low blood pressure. 

Resuscitation measures were attempted, but not successful. Mr. 

Martin was pronounced dead at 8:25, June 22, 1996. 

Upon learning of this event, I immediately convened a three-person board of investigation to thoroughly investigate all the circumstances surrounding Mr. Martin's death; and I would like to 
38 

say at this point that I am a former Staff Investigator for the 

House Veterans Affairs Committee, and when we conduct an investigation, my medical center, I usually assist in all investigations to 

make sure that they are thorough and complete. 

I then contacted his family. Mr. Martin had been separated from 

his wife for more than 23 years. His sister was identified as his 

next of kin. I nevertheless contacted the widow and the sister, and 

invited them to come to the medical center. They came to the medical center, and I informed them that an investigation was under 

way, because I was not satisfied with the events leading up--the 

circumstances leading up to Mr. Martin's death. 

At the same time I had directed the investigation be conducted, 

I also ordered that the two dialysis nurses, the dialysis technician, 

the dialysis unit nurse manager be removed from the dialysis unit 

pending the outcome of the investigation. 

After the board of investigation was completed, the following actions were taken. The employment of the primary nurse assigned 

to Mr. Martin was terminated, and the nurse was reported to the 

State licensing board. She immediately left the country and I believe is somewhere in either Puerto Rico or Guam. 

The second dialysis nurse was suspended for 30 days and reassigned. She resigned from the VA. 

The nurse manager of the dialysis unit was suspended for 14 

days, and was permanently reassigned. The dialysis treatments 

were moved to newly constructed dialysis units, which had been 

planned prior to the incident. 

The nursing staff of the dialysis unit was redesigned to ensure 

a more uniform approach among all staff members and with all patients. All the nursing leaders within the dialysis unit were given 

formal leadership training. All dialysis staff members have been 

engaged in ongoing training procedures relating to administrative 

and clinical problems and procedures. Plans are under way for all 

members of the interdisciplinary dialysis team to participate in a 

team-building program in order to advance a positive, cohesive 

team spirit that has been developed since this tragic accident. 

In conclusion, let me say-and I am a retired Marine Corps paratrooper, and I saw a lot of combat and I had multiple gunshot 

wounds; believe me, I have empathy for my patients, my veterans, 

and I relate to them. And as I indicated earlier, this was a tragedy 

that affected me very personally. 

We pride ourselves on providing the best possible care to our patients, and to have something of this nature occur has required us 

to humbly sit back and take a look at ourselves, asking how we can 

ensure that something like this never happens again. We have 

learned many lessons from this tragedy and have emerged from the 

incident with a renewed sense of mission to do everything we can 

to provide the very best for our veterans, which they deserve. 

And we thank you very much for being able to come before you 

today. 

[The prepared statement of Mr. Doherty appears on p. 141.] 

Mr. STEARNS. Thank you. Mr. Valentine. 
39 

STATEMENT OF BILLY VALENTINE 

Mr. VALENTINE. Yes, sir. Mr. Chairman, members of the subcommittee, I have submitted written testimony that explains in detail the events that occurred at Muskogee VA Hospital. I will briefly take a minute to recap the events of May 24 and 25. 

I am pleased to be here this morning; it is just unfortunate it is 

under such tragic circumstances, that in 30 years in the VA I have 

but one opportunity to appear before a subcommittee, and it is 

under these tragic circumstances. 

Mr. STEARNS. That is a good point. 

Mr. VALENTINE. Our staff at Muskogee was saddened by the untimely death and also disappointed that this isolated accident so 

overshadowed the compassionate care that has been provided day 

to day at Muskogee VA Medical Center for over 60 years. The patient in question was a 65-year-old veteran admitted on May 22 

with a diagnosis of gastrointestinal bleeding with other complications. From the time of his admission, he had progressively improved medically. He exhibited appropriate interaction with staff, 

was judged to be oriented and competent to make his own decisions. He was receiving no sedatives, relaxants or psychoactive 

medications. 

On May 24, at approximately 10:30 p.m., the patient left the 

ward without telling the staff or signing out. We can only assume 

he left the ward to go for a smoke, as he had done that several 

times that day. The staff noted that he was missing about 15 to 

20 minutes after he departed the ward, and immediately began our 

search policy. 

At approximately 8 a.m. the next morning, May 25, the VA policemen found the body of the missing patient in the construction 

site adjacent to the medical center. Investigations were conducted 

by the Muskogee Police Department, the Board of Investigation 

and the Office of the Medical Inspector. The death was ruled an accident which was precipitated by the actions taken by the patient. 

We will never know why the patient went to such a seldom used, 

isolated smoking area, nor will we know why he disassembled a 

chain-link fence to enter the construction site, why he walked 40 

or 50 feet, over piles of bricks and construction debris, to the point 

that he fell to his death. 

What we have learned from this is that we have a commitment 

to continually analyze and redesign our systems to assure that our 

patients, employees and visitors are provided a safe environment. 

[The prepared statement of Mr. Valentine appears on p. 148.] 

Mr. STEARNS. Thank you, Mr. Valentine. 

Let me just echo your point about it is unfortunate that perhaps 

the one time you are coming in front of the committee, the subcommittee here, would be under these circumstances. But I think 

the larger issue is, how can we develop this culture that we have 

talked about, that we have a system-wide program to stop these 

and help out. So if all of us can work towards that, I think the larger goal will be immensely helpful to the VA hospital, and that is 

sort of the imprint we are trying to do here. 

So you are here obviously to try and improve the system and 

that is why-so towards that end, I understand that something 

happened in Muskogee, and then a year later, the same thing hap-
40 

pened in the Miami hospital; and if there had been actual reporting 

of this incident, perhaps the procedures could have been placed so 

that in the Miami hospital, it would not have occurred. 

To your knowledge, Mr. Valentine, did the Central Office prominently notify other VA medical centers of the lessons learned as a 

result of the incident to which you just testified? 

Mr. VALENTINE. No, not to my knowledge. 

Mr. STEARNS. Now, there is a good example, where if that was 

put on a bulletin board and notified, then Mr. Doherty and Dr. 

Headley could all look at it and say, by golly, here is something we 

should do to prevent something happening. 

Mr. Doherty, when the press reported that particular example, 

the kidney dialysis-and I used that in my opening statement-you 

went into the system-wide problems, the clinical problems. But the 

press has identified other patient deaths at the Miami hospital; I 

understand there have been four more cases involving failure to 

treat a veteran's bladder cancer, for example. 

So my question is, have all of these cases prompted a broader review of the systems of care delivery at your hospital, and is this 

a change in philosophy that is just starting now, or what can you 

say? 

Dr. DOHERTY. I think, number one, we regret-as Dr. Kizer indicated, one death is one too many, and we regret that any deaths 

occurred-untimely and unwarranted deaths-and I think that 

each case has to be viewed separately. 

And I think that, yes, we have instituted a system whereby-and 

Dr. Kizer, I think, alluded to that in his statement-the VA is 

going to have a database system whereby all of this stuff will be 

funneled in to headquarters. When anything occurs at our medical 

centers, we immediately notify our VISN director, and he in turn 

notifies our headquarters, Central Office, of the incident; and immediate steps are always taken at the medical center level to determine what happened, how did it happen, why did it happen, and 

what steps can be taken to prevent it from happening again. 

And not all of these things that happened can be blamed on the 

medical center or the failure of medical center personnel to act 

properly. For example, you mentioned the case of the missing 

patient. 

Mr. STEARNS. Right, which you talked about. 

Dr. DOHERTY. The patient was brought to our hospital, he had 

a fire in his home, his wife brought him to the hospital and asked 

if we would hospitalize him because he could not get along with his 

mother-in-law and we agreed to take him in. He had been a patient 

previously in our nursing home and we had had the gentleman on 

the locked ward, secured unit, of the nursing home. His wife was 

determined that he was not going to be placed on the secured unit, 

locked ward of the nursing home; she felt this would be counterproductive and that he would lose all the confidence that he had, 

and that he was able to take care of himself. 

A conference was held at the nursing home, and it was determined they would go along with the wife of the veteran, and they 

placed the veteran in an unlocked ward. Four days later, he wandered away from the ward. 
41 

Mr. STEARNS. And we looked at the Dillmore case in November 

of 1996, where wheelchair brakes failed and the individual toppled 

from the bus and was killed. 

Dr. DOHERTY. Yes. 

Mr. STEARNS. The Ribler case in 1995, the patient died after VA 

failed to-well, what I am saying is, all these things should have 

prompted a system-wide--

Dr. DOHERTY. Well, I think we are continually in a system-wide 

investigative posture to make sure that there are no accidents or 

untoward events that are occurring in our medical center. I think 

this is a daily occurrence, and I think that we take great pride in 

our medical center, in ensuring that our veterans not only receive 

quality care, but we take every measure to ensure their safety. 

In the case of Mr. Dillmore, sir, I can assure you, we took Mr. 

Dillmore out for an outing to buy some stuff at a local shopping 

center. Upon his return, he was loaded onto the elevated wheelchair lift. Mr. Dillmore was a quadriplegic and he operated his 

wheelchair by his chin. When he was loaded onto the wheelchair, 

he put his wheelchair into motion, and it was a very heavy wheelchair, electric-powered wheelchair, and the attendant was unable 

to stop the wheelchair from moving forward. Mr. Dillmore had full 

control of that wheelchair, and he toppled over and fell 4 feet to 

the pavement. 

He indicated he was all right, and we immediately rushed him 

to the Parkway Medical Center; and unfortunately, he did expire, 

but I don't think it was a system failure. As-again, as in Mr. Martin's case, it was not a system failure; it was a case of failure of 

one individual to properly perform their duty. 

But in answer to your question, sir, yes, we are daily evaluating 

and measuring what steps can be taken to prevent any untoward 

incident from happening in our hospital. We are constantly putting 

systems into effect. 

Mr. STEARNS. I would submit, though, Mr. Doherty, if a person 

is controlling the wheelchair with his mouth, he should not be in 

control of the wheelchair when he is on that kind of structure. 

Mr. DOHERTY. You are absolutely right, sir. 

Mr. STEARNS. But be that as it may, here is something that I 

have no feel for and this is a general question for all of you. 

There were some $53 million paid in malpractice cases in 1996, 

fiscal year. And I read earlier that the hospitals have an obligation-as opposed to the private sector, they have an obligation to 

pay for negligence and errors and so forth. How has that impacted 

your hospital, the fact you have malpractice-and I might ask Mr. 

Headley, and I will move from my left to my right-because, you 

know, we have records of malpractice insurance claims and, obviously, in which hospital it occurred. 

For example, in Mr. Doherty's hospital, it is my understanding, 

more than 4.4 million was attributable to cases involving your facility, and so I think just my question is not specific to any individual. And I don't even have a feel if 53 million is a lot. But just tell 

me, from your standpoint, this malpractice, is this a concern of 

yours at all; and is there something that the committee should 

know in reference to these claims? 
42 

Dr. HEADLEY. Well, I think malpractice is always a concern because it indicates that there has been a failure of the system. It 

indicates that something has been done wrong. It indicates that 

there is something that we can improve. 

And indeed we use tort claims as part of our performance improvement activities. At the Boston VA, we do have a very mature 

performance improvement system, which has been in place probably for 20 years now which tracks and indeed does trend all of the 

various components of our quality management program. We look 

at tort claims, we look at patient incidents, we look at minor patient incidents, we look at medication errors, we look at all of the 

errors in our hospital. We trend these quarterly, we put them together annually, we share them with clinical staff, we take lessons 

from these; we use the tort claim data in order to improve performance. Financially, this is an impact; I don't know exactly how to 

compare this $53 million versus the private sector. 

Mr. STEARNS. I don't either. 

Dr. HEADLEY. And the amounts that go on there. 

Mr. STEARNS. Yes, sir, Mr. Doherty. 

Mr. DOHERTY. I would piggyback on Dr. Headley's statement. We 

are doing all of the same things that he indicated. To me, today 

it is very-you know, we get many frivolous claims that we have 

to entertain, and some of our-when you look at the malpractice 

suits that are filed, you wonder why there are so many. As I indicated, many of them are frivolous in nature, and the majority of 

the suits, claims that are filed against VA Medical Center of 

Miami, are denied. 

I personally encouraged the widow and the sister of Mr. Martin 

to file a claim, and that was the only claim that was filed in the 

five deaths, and I assisted them in filing that claim because I felt 

in this case that they were deserving of something. 

Mr. STEARNS. Mr. Valentine. 

Mr. VALENTINE. I share in the concerns, any time you have a tort 

claim filed, there is a perception by the patient or his family, that 

the care that they have received was inappropriate, and that is the 

last message any health care facility would want to send. We do 

trend and track the filing of tort claims regardless of whether they 

are accepted or whatever action happens on them just so that we 

can get some tracking process into what may be hot spots in the 

facility; and I would certainly feel that $53 million is a significant 

amount of money. That is enough money to actually fund one small 

hospital for a year's operation. So we do have a concern. 

Mr. STEARNS. Okay. Mr. Kennedy. 

Mr. KENNEDY. Thank you very much, Mr. Chairman. 

First of all, I was struck by the testimony that the three of you 

gave in terms of just how it seemed as though you all cared very 

deeply about the loss of life that took place in your facilities, and 

I think that is an important demonstration for not only the people 

here, but for your staff, as well, to understand, you know, just how 

important these lives are that you are taking care of. 

I think, you know, it is also important to point out, as I understand, that there are about a million cases each year of patients 

that are injured by mistakes in treatment and that over 120,000 

of them across the United States die, so I don't think that we are 
43 

here to just try the three of you based on the fact that there are 

incidents in each one of your facilities where people have been 

killed as a result of inadequate or wrong medical treatment. 

I do think what we are trying to do is determine whether or not 

appropriate steps are being taken by your facilities, and whether 

or not there is a systemic problem that needs to be fIxed, and I 

think there are enough incidents that have taken place around the 

country over the course of just in the last 10 years or more, since 

I have been serving on this committee, that would lead one to believe that there is, in fact, some kind of underlying problem that 

needs to be dealt with. And I think that I would like to just pursue 

that and get your thoughts on whether or not there is in fact, you 

know, a deeper issue that needs to be examined by this committee 

and dealt with either legislatively or administratively. 

First and foremost, I mentioned in my opening statement, when 

I was talking to Dr. Kizer, I remember-and I don't have a listing 

in front of me, but I remember, I believe it was in Columbia, Missouri, there was an incident in the last couple of years where there 

was sort of a rogue individual running around killing a whole rash 

of different patients. 

I remember there was another incident where there were patients' bodies that were found buried on VA grounds. There were 

all these kinds of cases, you know, in terms of bodies being lost in 

various exits and horror story after horror story after horror story. 

We are told that these are sort of different, isolated incidents 

that have no reasonable relationship to one another. On the other 

hand, we have heard, I think, enough of them to, for instance, have 

the chairman of the subcommittee call all three of you here to ask 

you what is going in your facilities; and the real question is whether or not there is a systemic problem that either requires additional resources-I mean, Dr. Headley, I noticed you brought up 

the JCOA. Now, as you may recall, we had to bring in the Joint 

Commission to inspect the Court Street Clinic, going back several 

years ago. When they came in and looked at Court Street, they condemned the place. Subsequent to that we got a very nice new temporary facility where the veterans are very, very happy in terms 

of the quality of care they received. But it did take bringing JCOA 

in to condemn an older clinic in order for us to move on and get 

the kind of funding that was required, and I am wondering whether or not-you know, what brought JCOA into your situation. 

You indicated, I thought, according to your testimony, that they 

had come in and given you some sort of status that was not exactly 

adequate, and you then made some improvements to get yourself 

into the adequate category. So can you just explain what happened 

there, please? 

Dr. HEADLEY. Yes, certainly. The Joint Commission is routinely-let me back up one step. When there is an incident involving blood administration, it automatically gets reported to the FDA 

as a part of the external reporting mechanism. The FDA notifIes 

the Joint Commission and the Joint Commission does go in and investigate each case of this nationally. So this was a routine visit 

of the Joint Commission for an incident. It is called a visit for 

cause, and it is for death involving blood administration. 
44 

The surveyor who came to us said that they investigate three to 

five of these nationally a year-not in VA hospitals, but nationally. 

At the time that the investigator came in, we had already done our 

administrative Board of Investigation, and I believe had already 

done our root-cause analysis. 

The Joint Commission surveyor who came in said that, indeed, 

you have basically done all of the things, you are basically in compliance, but we will put you on what is called "accreditation watch" 

until you implement all of the recommendations that you came up 

with. 

Mr. KENNEDY. Does that indicate that, in fact, you were below 

their standards prior to their arrival? 

Dr. HEADLEY. It means we had an incident. 

Mr. KENNEDY. If it is on some sort of temporary status, after 

they arrived, doing the investigation, it would imply that you were 

not operating at the status that JCOA requires. 

Dr. HEADLEY. I am not sure what accreditation watch exactly 

means. It is something that they implemented about a year and a 

half ago. They made organizations conditional; they rendered them 

conditional accreditation if they came in and investigated an incident, until they took some remedial steps. 

Mr. KENNEDY. Well, it bothers me a little bit to hear you say you 

don't know what that means. I mean, I am not trying to be unnecessarily hard on you there, Doc, but you know, you are the administrator of the hospital, and if the accreditation board is coming in 

and you are saying that they are not giving you an adequate-you 

are saying to us before the committee they didn't give you an adequate appraisal, they put you on temporary status, and you are 

saying to me you don't understand what they really meant by--

Dr. HEADLEY. I understood exactly what they meant for us. What 

I am saying is, I am not quite sure what "accreditation watch" 

means in terms of Joint Commission accreditation, it doesn't have 

an official sort of-it means that they detected in our blood administration program some areas that could be improved. 

For instance, we had said that we felt that having the refrigerator in the operating room and blood delivered to that refrigerator was a potential cause of error in the administration of blood 

in the operating room; and we had determined that we were going 

to remove that refrigerator, we were going to replace it with blood 

being delivered directly to the operating rooms from the blood 

bank. We instituted that as part of our systems process. We 

changed-the Joint Commission surveyor said and felt that an 

interdisciplinary identification of patients in the operating room 

was better than having each discipline identify the patient separately, having physician identify, having nurse identify, and we 

changed that procedure in our operating room. 

Mr. KENNEDY. And I appreciate the Chairman to just give me a 

minute to wrap up here. 

But I heard in your testimony these changes you made, and I 

think the question before the committee is whether or not these are 

changes that should have been imposed as a result of normal oversight by an administrator of a situation involving a life-threatening 

procedure. 

Dr. HEADLEY. Yes, they are. 
45 

Mr. KENNEDY. And whether or not these are, you know, where 

people aren't looking to, you know, just come in and sort of gratuitously whack you around here Dr. Headley. 

What I think it is our responsibility is to make certain that, in 

fact, proper oversight of administrative procedures is going on 

within the VA; and I am still, to be honest with you, Mr. Chairman, somewhat unclear as to how that has occurred here. 

Mr. STEARNS. I will tell my colleague, we can go another round 

if you like. Let me call on my colleague, Mr. Bilirakis, who, I might 

point out, is the Chairman of the Commerce Health Subcommittee, 

which deals with Medicaid and part of Medicare, so he has large 

jurisdiction. My colleague. 

Mr. BILlRAKIS. Thank you, Mr. Chairman. 

I want to welcome the gentlemen, and particularly Mr. Doherty, 

who comes from our State, even though it is not our congressional 

district. And really, Mr. Kennedy hit upon it, and before you came 

in, Joe, we talked about the need for cultural change. I mean, there 

is an atmosphere there that really many of us think results in a 

lot of these problems and you hit upon it. 

Let me ask you, Mr. Doherty, in the case of Mr. Martin, who bled 

to death while receiving the dialysis, the St. Petersburg Times reported it took ten-and-a-half months to report the nurse responsible for the incident to the State licensing authorities and the national data bank that collects the names of medical professionals 

who err; is this correct? 

Mr. DOHERTY. Yes, sir, but I think it needs explanation. 

It wasn't a delay; we had to conclude the investigation and the 

other processes that are necessary before reporting to the national 

data bank. 

Mr. BILlRAKIS. Is this a process? 

Mr. DOHERTY. This is a process, Mr. Bilirakis, that we have no 

control over; it is something that is imposed upon us. 

Mr. BILlRAKIS. By whom? 

Mr. DOHERTY. By the data bank and by the system, the system 

beingthe--

Mr. BILlRAKIS. By the data bank, in other words, the national 

data bank? 

Mr. DOHERTY. We have to furnish certain documentation, including a report of investigation and other matters, meaning that this 

case is finished by the VA and has been investigated by our peers 

and everything else. 

Mr. BILlRAKIS. But in the meantime, during this almost 11-

month period of time-this nurse is no longer in the VA system? 

Mr. DOHERTY. She immediately left the VA. We suspended her 

immediately and then terminated her. Upon completion of the investigation, she returned to her home in Puerto Rico. As I understand, now she is in Guam, but her license was pulled. 

Mr. BILIRAKIS. Well, you know, there is a period of time there; 

in other words, during this approximately 11 months, she could 

have gone out, and maybe she did go out and get a job as a nurse 

someplace. 

Mr. DOHERTY. You are absolutely right, sir, and this happened 

with the young lady we suspended for 30 days, she resigned and 
46 

went to work immediately for the Cedars of Lebanon Hospital, directly across the street from us-at higher pay, I might add. 

Mr. BILlRAKlS. Well, and then what happened, did you plug her 

into the national data bank ultimately? 

Mr. DOHERTY. Her offense was not reportable to the national 

data bank. 

Mr. BILlRAKlS. It was not reportable? 

Mr. DOHERTY. No, sir. There are certain parameters that we 

have to follow and requirements for reporting to the national data 

bank. 

Mr. BILlRAKlS. By "the national data bank," they are not VA requirements, they don't come from headquarters in Washington? 

Mr. DOHERTY. Right. 

Mr. BRADSHAW. Excuse me. 

Mr. BILIRAKlS. Yes, sir. 

Mr. BRADSHAW. Mr. Bilirakis, I am Doug Bradshaw, Assistant 

General Counsel in the VA, and just to clarify the reporting to the 

data bank, for adverse personnel actions, the data bank takes reports on licensed physicians and dentists, but not nurses. For malpractice payments, we can report any licensed provider. 

Mr. BILlRAKlS. For malpractice payments? 

Mr. BRADSHAW. Yes, and in this case there was a malpractice 

claim filed, it was settled and upon settlement and payment of the 

claim, the data bank procedures went into effect at that stage and 

the nurse was reported for the malpractice payment. That is what 

the time lag was. 

Mr. BILlRAKlS. Due process is very important and we don't want 

to watch a person, just because of a particular event which maybe 

has not been proven yet, that is a result of his or her negligence, 

to suffer. On the other hand--

Mr. DOHERTY. I think the unusual delay in this case, sir, was because of the tort suit claim that had been filed. 

Mr. BILIRAKlS. And you felt-in other words, you didn't want to 

interfere with the legal process is what you are basically saying, I 

guess. 

Mr. DOHERTY. Not exactly, not with the VA. 

Mr. BILlRAKIS. Well, you know, Mr. Doherty-let me ask, do you 

hire your physicians? Who hires physicians, who hires nurses; do 

you have the kind of authority to hire people? 

Mr. DOHERTY. Are you asking me? 

Mr. BILIRAKlS. Yes, I am asking all three of you. 

Mr. DOHERTY. Yes, sir. But our physicians-we have-naturally 

they go through a clearance, and the chief of staff and his staff and 

the credentialing of people, I mean, to make sure--

Mr. BILIRAKlS. The "chief of staff," meaning up here in Washington? 

Mr. DOHERTY. No. The Chief of Staff at the Medical Center have 

the final say in the matter. 

Mr. BILIRAKlS. Mr. Doherty, you indicated you were a paratrooper, you were wounded in action, et cetera, so you care about 

the veterans; and Mr. Kennedy talked about the strong feeling all 

three of you showed as far as caring is concerned. 
47 

If a person who is a medical doctor applies, and you find out that 

this person failed the test 10 times in succession, would you still 

hire them, him or her? 

Mr. DOHERTY. I would probably stand to run the risk of losing 

my job, but I don't think I would, no, sir. 

Mr. BILIRAKIS. Well, there has to be some courage, some guts 

here somewhere, for crying out loud. 

Mr. DOHERTY. I would be very suspect of anybody that failed because, like with the bar exam, if you failed the bar exam seven or 

eight times--

Mr. BILlRAKIS. The bar exam is probably not life and death either, but here we are talking about life and death and we are talking about veterans besides. 

Mr. DOHERTY. Yes, sir, I understand. 

Mr. BILIRAKIS. And it kind of blows my mind to see these things 

happening. You know, perception, as we find out up here, sometimes is more significant than facts. 

Let me get back to some of the cases. George Dillmore, the metro 

Dade police say unfortunately they have been uncooperative, we 

have not gotten anywhere with them. I don't understand what the 

big deal is; all we want to do is talk to the people who were there. 

Accidents do happen. Apparently they were stonewalled, right? 

Mr. DOHERTY. Mr. Bilirakis, the metro Dade police know they 

have access to my office, to our security and police office. They did 

not contact us. They contacted a clerk in our Medical Release Bureau, and the young lady--

Mr. BILlRAKIS. She was unauthorized probably to talk to them. 

Mr. DOHERTY. Yes. After reading about the article in the St. Petersburg Times, we contacted the officer. It took us 7 days to make 

contact with him. 

Mr. BILlRAKIS. You tried to contact him? 

Mr. DOHERTY. Then he finally contacted us and we are cooperating with him, we told him, you know, all the years we have been 

in business, the police department comes to us, police and security, 

we cooperate fully, but we have to be very careful of the Privacy 

Act. 

Mr. BILlRAKIS. And I can understand, things happen and there 

is some sensitivity to them, and just anybody doesn't have the authority to talk to-whether it be law enforcement or whatever. But 

these things take place. 

You know, the case of the American Legion commander, Mr. 

Fincham, I believe it was. 

Mr. DOHERTY. Yes, sir, Fincham. 

Mr. BILlRAKIS. Well, Mr. Fincham. The names off the top of other 

x rays were cut, the x rays involving Mr. Fincham's situation disappeared. No one owned up to altering the missing and defaced x 

rays. The hospital's associate director said Friday the x rays later 

turned up. 

You know, it doesn't sound right. 

Mr. DOHERTY. I can understand, Mr. Bilirakis, and I fully appreciate what you are saying. In the teaching setting that we-we are 

an affiliated medical school-the identity of the patient is removed 

from the x ray when it is used for teaching purposes. This probably 
48 

happened. I am not saying it did, but this probably happened in 

the case of Mr. Fincham. 

And in the case of Mr. Fincham's death, I would like to say this. 

Mr. Fincham, God bless him, was a very, very heavy man, it took 

four or five nurses to get him back in bed when he fell out. He kept 

putting his side rail down, and he was always pulling his IV s out 

and pulling his tubes out; and we had a sitter with him, and there 

was no clear-cut evidence, but it is highly believed that he removed 

the tracheal tube himself and it was put back in by the sitter. We 

have no evidence to indicate otherwise, but we have no evidence to 

indicate that this actually happened. But I think it should be 

known. 

Mr. BILlRAKIS. Thank you, Mr. Chairman. 

Mr. STEARNS. I just have two questions, I guess. 

One, Mr. Doherty, I mentioned earlier, there is $53 million in 

malpractice insurance in fiscal year 1996; $4.4 million was attributed to your facility. No other facility had more than $3 million. 

Can this be explained? Is this just an aberration? 

Mr. DOHERTY. We are one of the most active medical centers in 

the State of Florida, and one of the busiest; and many of our patients come to us, believe me-I mean, we take care of very, very 

sick patients. I am not saying these cases were not legitimate, but 

I can cite one case that I have very strong, serious doubts about. 

I don't think anyone wants me to go into that, but I deeply regret 

that this kind of money has been paid out in the settlement cases, 

Mr. Stearns. 

Mr. STEARNS. I understand. 

Let me just conclude my questions, and Mr. Kennedy and Mr. 

Bilirakis can ask another series of questions afterwards. 

Dr. Kizer has instituted new policy procedures. The Washington 

Post had an article yesterday where he says, basically, the simple 

fact is that too many adverse events happened as a result of medical treatment, and he says he is going to do all this new systemnew policy. 

What specific steps have been or will be taken at your facility to 

carry out that policy, and how will it be different if we come back 

here in 1998 and we are talking. And this is for each one of you. 

Mr. DOHERTY. I would think the system-we are in a tracking 

mode now; we track everything that happens in hospital medication-errors and untoward incidents, everything else that occurs, 

this is tracked and documented, this is reported, and the database 

is set up so that we will know instantly, and all the care-givers will 

be given access to know, so that we can identify areas that havethat are suspect and that people can look into and find out just 

what is happening here, that we have so many errors, medication 

errors and other things. 

So I think that Dr. Kizer is on-I think he is taking a very aggressive role in this thing. And he indicated to us in our meeting 

yesterday that he intends to set up a database where all of this 

stuff will be funneled into headquarters, and the medical centers, 

everyone will have access to know where things are occurring, why 

they are occurring, how can we prevent them, how can we stop 

them, what is necessary to change the system. 

I think it is a wonderful step that he is taking. 
49 

Mr. STEARNS. Mr. Valentine. 

Mr. VALENTINE. Well, I agree with Mr. Doherty. I think the VA 

handbook, 1051, is probably the most cutting-edge document that 

I have seen on risk management in health care for some time. 

Many of the issues covered in the handbook are activities that are 

going on within facilities at this time. I think the most significant 

area that must be put into place, if we are really going to reap any 

bet;l.efits from the changes, is that we need to be able at the facility 

level to learn very rapidly what has occurred at other facilities, 

what caused sentinel event to occur and what actions were taken 

to prevent a reoccurrence of it. 

I think the failure in the system in the past has been that we 

don't find out about these things in a timely manner, like was said 

earlier in the panels, that information may sit in a room for 2 years 

with no follow-up action; and if the steps that are outlined in the 

VA handbook in fact are implemented, and that that processing 

house and headquarters in fact do disseminate the information to 

the facility, I think the facility will benefit from this. 

Dr. HEADLEY. I would like to agree with the previous two speakers. I think that the VA has an opportunity to lead the way in the 

improvement of errors in medical care and the damages that occur, 

because we do have an integrated national system that is capable 

of pulling the information together and sharing it throughout the 

system. 

I think that many of us have had very active quality improvement, performance improvement, risk management programs at 

our facilities, but we have not necessarily had the benefit of findings at other facilities. There have been times in the past when 

this information has been shared, but it has not been continuous. 

I think that the plan that is currently in place makes this a very 

real possibility, and makes us have the potential to really make 

some significant contributions to the national effort, not just the 

VA, but to the national effort of reducing errors in health care and 

deaths secondary to those errors. 

Mr. STEARNS. When you mention the responsibility, we probably 

have a moral responsibility, even more so, than the private sector 

because these·are veterans. Mr. Kennedy. 

Mr. KENNEDY. Thank you, Mr. Chairman. 

I want to come back to the issue we were discussing, Dr. 

Headley. I mean, I think that if you look at any profession where 

there are life-threatening situations, whether you are talking about 

a military situation, which has reasonably well-defined rules of engagement, if you look at the rules that police officers and fire departments or other people that are involved in the setting of health 

and safety of the American people, there are fairly strict rules and 

regulations which folks have to follow. 

Now, as I understand, in the Boston situation where this fellow 

received the wrong blood, the two nurses that were involved in the 

transfusion still work at the VA facility. The anesthesiologist quit, 

so they took this on themselves to deal with what their future was, 

and the situation where the VA fired the anesthesiologist; no one 

going up the management scale in any way was penalized that I 

am aware of. 
50 

Is it your opinion that this was simply a situation where a procedure was in place that was inadequate, that had no-where there 

was no demonstrable responsibility by any health care provider to 

anticipate the risk that the patient was being put in? 

Or, in fact, is this the kind of situation where, when the monitoring body of the government came in and looked at it and said, hey, 

wait a minute, this thing is not-you know, you guys aren't following the procedures that you ought to be here, and therefore we are 

putting you on hold and not giving you, you know, the sort of gold 

star or the green light on your current procedures, and you have 

got to bring your procedures up to a certain standard, and then you 

were going to then give them the kind of-the checkoff saying, you 

are in good shape? And if, in fact, it is the latter, is it your opinion 

that no one should have been fired, no one should have been in any 

way held accountable for this loss of life? 

Dr. HEADLEY. Mr. Kennedy, we did a thorough Board of Investigation; at the time that this incident happened, reprimands were 

issued to the physician and to the two nurses involved in this. 

Mr. KENNEDY. What does that entail, Doc? 

Dr. HEADLEY. A reprimand is a letter and a counseling to an individual that there has been a problem with their performance, it 

is expected that this performance will improve, that they are being 

monitored for performance in this area, and that this letter goes 

into their personnel file. 

Mr. KENNEDY. Permanently? 

Dr. HEADLEY. It goes in for I believe a period of a year and it 

goes-it can be removed after a year. 

Mr. KENNEDY. Were these removed? 

Dr. HEADLEY. I don't believe they have been at this point in time. 

Mr. KENNEDY. But you don't know? 

Dr. HEADLEY. I don't know if they have been removed yet. 

Mr. KENNEDY. Do you think that is appropriate? Do you think it 

is appropriate? 

Dr. HEADLEY. That they be removed? 

Mr. KENNEDY. I am trying to understand. You know, somebody 

died in this case. 

Dr. HEADLEY. Yes. 

Mr. KENNEDY. I am not an expert on what hospital emergency 

room or operating room procedures are, so I feel somewhat uncomfortable in trying to understand exactly whether or not there was 

greater risk and responsibility than is being owned up to here. And 

as I said before, it sounds like there is the possibility that that is 

the case, and I am trying to get a better understanding of whether 

or not this was simply a situation where, you know, year in and 

year out, we followed these certain procedures. It has always 

worked before and, gosh, nobody ever anticipated that this particular situation would occur; and therefore, somebody accidentally 

died, and now we have to go fix up what had been accepted, reasonable procedures. 

This is a very different circumstance than, look, you know, there 

was a procedure set up over in this particular operating room that 

was half-baked, harebrained, and people were putting patients at 

undue risk, and as a result, an individual died. 
51 

You know, we have got two letters of reprimand that go into a 

file for a year; they are then withdrawn. And the anesthesiologist 

quits, and I don't know if he went off and got a better job, like the 

nurse did, but you are leaving open the possibility that accountability was not placed in order here, right, and that is what I am trying to get at. 

Dr. HEADLEY. Yes, I think that we do take this very seriously. 

I think that we have policies and procedures in place in the operating room, in the administration of blood, that we expect people to 

follow. 

We have a transfusion committee---

Mr. KENNEDY. I understand all that. I don't want to hear about 

all of the--I am just trying to understand whether or not the procedures that were in place were, in your opinion, adequate, given the 

historical record; or whether or not they were, in fact, inadequate. 

Dr. HEADLEY. Yes, I believe that the procedures that were in 

place were adequate, given the historical record. The procedures of 

checking an arm band before you administer blood and checking it 

against the blood, for some reason, this procedure was not followed. 

There was another procedure--

Mr. KENNEDY. So the procedure that was acceptable was not followed? 

Dr. HEADLEY. It was not followed. 

Mr. KENNEDY. And even though the procedure that was acceptable was not followed, the only thing that occurs in terms of disciplinary action is a letter of reprimand. 

Dr. HEADLEY. That is correct. 

Mr. KENNEDY. Do you think that is adequate? 

Dr. HEADLEY. I don't know; I have thought a great deal about 

that. 

We heard this morning from Dr. Leape about the need to change 

the way we approach errors of this sort to become less punitive, so 

that people will be forthcoming in discussing errors when they are 

made and trying to improve systems so that these will not occur; 

and Dr. Leape made some very compelling arguments about this 

this morning. 

When we approached this, we approached it in a twofold manner; 

we approached it in looking at individual performance and we approached it in looking at systems problems. 

Mr. KENNEDY. Well, if we have gotten to a point where we are 

now saying we are going to forgive, you know, just blatantly, sort 

of inadequate procedures and the performance of those procedures 

in order to have a greater amount of openness, you know, we are 

entering the realm of the bizarre. 

I am all for having procedures where people aren't going to be 

hurt by coming forward with problems that exist in a system, but 

that should never get in the way of creating adequate responsibility 

on behalf of individuals to do their jobs properly, and-I mean, you 

know, if somebody isn't following procedures, and it ends up that 

a patient is killed-I mean, it is up-that is your job, to determine 

what is the proper way of handling it. 

You can get a bunch of Congressmen to come up here and try 

to tell you that, but ultimately you are the VA administrator. 

Dr. HEADLEY. That is correct. 
52 

Mr. KENNEDY. All right. 

Mr. STEARNS. The gentleman's time has expired. 

We have a vote, but I think we have enough time for Mr. Bilirakis. 

Mr. BILlRAKIS. I will just hustle through this, Mr. Chairman. 

Gentlemen, some Members of Congress claim that the VERA, the 

new resource allocation method, of course, which has not been in 

place all that long-and a lot of these problems occurred long before VERA-is the cause of poor patient care in areas of the country which receive under VERA less funding. 

Do you, Dr. Headley, believe that VERA is having an adverse impact on those areas of the country, such as yours, for instance? 

Dr. HEADLEY. I can't really say at this point in time. I don't believe that, as yet, we have experienced the full impact of VERA. 

Mr. BILlRAKIS. There is one particular delegation that is very 

vocal here who are maintaining that and your delegation is not in 

that category, but I appreciate your honesty. 

Mr. Doherty and Mr. Valentine, I don't know if you have any 

quick comments regarding that. 

Mr. DOHERTY. I think VERA has enabled us to provide quicker 

access and faster delivery of service by opening up communitybased outpatient clinics; and we have opened up two of them, and 

our veterans, I think, are now being better served. We get a lot of 

snowbirds down in Miami, so we are very grateful for the extra 

money we get. 

Mr. BILlRAKIS. I am going to go on here, Mr. Valentine; if you 

will forgive me, I am going to finish it up. We have heard about 

new procedures put into place, and if you all were in the room, you 

heard my opening statement. 

I think that VA health care is pretty darn good in general, but 

we have heard about some of the things that have taken place, we 

have heard that cultural changes need to take place, we have 

heard about how existing civil service laws make it very difficult, 

sometimes almost impossible, to fire Federal employees and how 

that is a problem-and, boy, I would like to spend a little more 

time on that with you, but time doesn't permit be~ause of the vote. 

And we have heard that on October the 6th, a couple of days ago, 

VA announced a national effort designed to improve the safety of 

patients at its hospitals. 

I guess some of you all, in responding to the Chairman and to 

Mr. Kennedy, you talked about certain ideas put into place. It 

seems to me practically every one of those ideas are common sense, 

and I sit here and I sometimes wonder, well, hell, why haven't they 

been in place all along anyhow? Does it take a newspaper article 

to kick this thing oft? Does it take then Mr. Kizer-Dr. Kizer to basically maintain these things are put into place? It seems like good 

gentlemen, caring as much as you do, would have probably put 

some of these things into place all along. 

We have heard during sexual harassment about, as I said before, 

a good old boys network and protecting one another and things of 

that nature. I tell you, the image is not as good as I think it deserves to be, because I don't think that health care in general is 

a bad system of health care or a bad quality of health care-maybe 
53 

that is the best way to put it-through my experience with the VA; 

and I have had some experience. 

But we have got to do something about these things, and we invited Dr. Kizer-and I know the Chairman was going to reiterate 

the invitation, Dr. Kizer, to kind of tell us how Congress can help 

in terms of the changes that maybe can be made in the laws to be 

of some help. And I would strongly urge you-and we don't have 

the time now because of the vote--I would strongly urge you to 

submit your inputs to Dr. Kizer, and if Dr. Kizer ignores some of 

them, if you want to get them to some of us around the bend, so 

to speak, we certainly would welcome that. 

But if we are going to help out here, we have to change, I think, 

our mental outlook, starting at the top and going all the way down 

to that clerk in the lobby when the VA member or when the family 

first comes in; and some of them are just not as courteous as they 

should be. 

Having said all that, Mr. Chairman, thanks very much. 

Mr. STEARNS. I want to thank my colleagues for their second 

round of questions, and I want to thank our panelists for their patience and waiting between votes and everything. 

We now call the subcommittee of health adjourned. 

(Whereupon, at 1:32 p.m., the subcommittee was adjourned.] 
APPENDIX 

Statement by Rep. Luis V. Guti~rrez 

Subcommittee on Health 

Committee on Veterans' Affairs 

U.S. House of Representatives 

October B, 1997 

Thank you Chairman Stearns. 

Allow me to reiterate the importance of the subject matter of this hearing 

today. 

Improved patient safety and the prevention of unplanned clinical 

occurrences is a goal we all wish to achieve. 

In this regard, the Department of Veterans Affairs, our nation's largest 

health care provider, is no different than non-governmental health care 

providers. 

However, the VA serves a unique patient base and thus carries a unique 

responsibility to address patient safety. 

The VA, as a government provider, is also under the budgetary 

corstraints imposed upon it by Congress. 

And because this committee is responsible for oversight of veterans 

health issues we are also responsible for the health of 

veterans who use the VA for medical purposes. 

I believe this hearing is particularly timely. 

Unanticipated deaths at a number of VA medical facilities have raised our 

awareness of patient safety issues and the adverse medical effects that 

occassionally result from medical treatments. 

(55) 
56 

Thp qotistics do not point to a greater number of unanticipated deat"s at 

VA hospitals nationally for this year, but cases in Ohio and in upstate 

New York demonstrate the need for new approaches to be developed and 

implemented to address this problem. 

I am pleased to see the VA start this process. The VA's recently 

announced partnership to address these important issues in conjunction 

with other national health care organizations, such as the American 

Hospital Association (AHA) and the National Patient Safety Foundation of 

the American Medical Association (AMA), is certainly a positive step. 

ThlJ implernpn. 'ltinn of a comprehensive risk management striH"gy with 

concrete proposals for preventing injuries to patients, visitors and VA 

employees is also a useful endeavor that should help the VA synchronize 

its efforts throughout the system. 

Ensuring the quality of care throughout the VA is vitally important. 

Dr. Kizer you have admitted that health care quality varies from hospital 

to hospital, that some hospitals are better than others, and that some 

facilities have more reports of adverse events than others. 

For me, this variance from place to place means we are letting some 

veterans down and I believe that by failing to offer the best quality health 

care to all veterans, regardless of location or network, we in turn let all 

veterans down. 

To address this problem, the recent actions of the VA must be followed 

by more tangible steps. 
57 

Access to information must be improved. The reporting of adverse events 

in VA hospitals is even more inconsistent than the health care. 

A f Jrmal structure should be established to ensure that incidents of this 

nature are reported promptly throughout the system. 

In addition, the numbers of adverse events, facility by facility, year after 

year, must be chronicled. 

We cannot determine if VA health care has improved unless we have 

reliable statistical evidence. The VA must make this an urgent priority. 

Allow me once again to express my support for what the VA is currently 

doing to improve patient safety. These are positive steps worth 

commendation and they should help us all understand the true nature of 

this problem and assist in the creation of innovative solutions. 

I thank you all for jOining us here today to discuss this important issue 

and I look forward to questioning the witnesses later this morning. 

Mr. Chairman, thank you again. 
58 

THE HONORABLE JOSEPH P. KENNEDY, II 

Opening Statement 

before the 

Committee on Veterans Affairs 

Hearing on Improving Patient Safety 

October 8, 1997 

Thank you, Mr. Chairman, for holding this hearing today to 

decide what we can do to reduce errors and improve patient health 

care at V A Medical Centers. I want to welcome everyone who is 

here to testify, especially Dr. Elwood Headley of Boston's Veterans 

Affairs Medical Center, and Dr. Lucian Leape of the Harvard 

School of Public Health. 

We must acknowledge that accidental injury and death does 

occur in our VA hospitals, and in public and private hospitals 

across the nation. 

Dr. Leape made very good points in his testimony that human 

beings are not perfect, and that health care professionals do make 

mistakes. And he also pointed out that health care professionals 

are blamed for being careless when they make mistakes. But in 

fact, these mistakes are accidents waiting to happen due to the 

system - such as working double shifts and having twice as many 

patients to take care of. This causes fatigue in our doctors, nurses 
59 

and pharmacists. Inevitably, mistakes happen. And tragically, 

sometimes they happen at the expense of the lives of our patients. 

A tragic human error happened at the Boston V A Medical 

Center on March 5th of 1996, when Peter Anderson, an Army 

veteran who served in the Korean War, died after he was given a 

transfusion of the wrong blood type during surgery. The Boston 

V A Medical Center acknowledges this tragic human error and has 

taken corrective steps to try to minimize the chance this will ever 

happen again. 

Three days after the tragedy, the Boston V A began an 

investigation and improved their process of verifying patient IDs 

and their process of dispensing blood for transfusions. In addition, 

all hospital personnel are required to participate in programs on risk 

management, especially in the operating room. 

I am pleased to announce today that the Boston V A Medical 

Center was just surveyed last month by the Joint Commission on 

Accreditation of Healthcare Organizations, which gave Boston a 

rating of 96. This is an "A." It shows Boston is achieving safe, 

quality health care for its patients and is doing its best to minimize 

mistakes. I want to congratulate Dr. Headley for the high rating. 
60 

In general, we need to take corrective steps throughout our 

V A hospitals and our healthcare system across this country. 

We must put a stop to the statistics that indicate a million 

patients are injured by mistakes in treatment each year, and that 

120,000 of them die. We must develop a national system to track 

mistakes and implement effective corrections. We owe this to the 

families of patients we have lost through tragic mistakes, and we 

owe it to incoming patients who put their trust in health care 

professionals. 

Thank You, Mr. Chairman. 
61 

The Honorable Michael Bilirakis 

Subcommittee on Health 

October 8, 1997 

Hearing on the Prevention of Adverse Events in 

the Provision of VA Medical Care 

Thank you, Mr. Chairman. 

First, let me take this opportunity to commend you for scheduling this hearing. I also want 

to thank you for postponing this hearing from an earlier date so that I would be able to 

participate today. Unfortunately. a scheduling conflict would have made it impossible for 

me to attend the hearing on September 25th so I appreciate your cooperation on this 

matter. I would also like to welcome T.e. Doherty, the Director of the Miami VA Medical 

Center, to Washington. 

Today, we are going to be examining the issue of "adverse events" in the provision of VA 

health care and what is being done to prevent such incidences from occurring. An adverse 

event is generally described as u an unintended injury that was caused by medical 

mismanagement and that resulted in measurable disability." 

Earlier this year, one of my district newspapers printed a series of articles on VA health 

care. These articles chronicled the stories of a number of patients who died unexpectedly 

because of "adverse events." The paper reported that at least 23 veterans have died under 

unusual or avoidable circumstances at 17 VA hospitals and nursing homes around the 

country since 1993. These articles also recounted a series of mistakes that resulted in the 

deaths of 23 veterans in Florida. 

The accounts of the "adverse events" that led to the deaths or injury of veterans in VA 

medical facilities were disturbing. According to the news articles, two veterans suffered 

fatal burns in scalding bath water. Three more died after nurses gave them the wrong blood 

type. Another veteran receiving dialysis lost nearly two quarts of blood while his nurse 

talked on the telephone. Insulin overdoses, poisoned oxygen and malfunctioning equipment 

resulted in the deaths of other veterans. In some instances, misdiagnosis, delay or 

fragmentation in care led to the deaths of VA patients. 

Even more disturbing were the actions of some VA employees after the certain incidents 

occurred. In the case of the dialysis patient, the nurse and other employees attempted to 

cover up the incident by cleaning the area and hiding the information from the team that 

came to revive the patient. The nurse was eventually fired and the other employees were 

disciplined. 
62 

After reading these articles. I requested that our Subcommittee hold a hearing on these 

incidents. As members of the Subcommittee with jurisdiction over VA health care, it is 

incumbent upon us to investigate these incidents and whether or not adequate steps have 

been taken to prevent the same thing from happening again. 

As tragic as these incidents are, the purpose of today's hearing is not to condemn the VA 

health care system. In fact, I have always believed that the VA health care system is a 

national asset that provides high quality care to our nation's veterans. 

Throughout my congressional career, I have visited many VA medical facilities and met 

hundreds of VA employees who are dedicated to providing veterans with high quality care. 

Over the years, I have also heard from many veterans who have taken the time to share 

their positive experiences at VA medical facilities with me. 

Moreover, adverse events are not unique to the VA. A 1993 Harvard study estimated that 

one million preventable injuries and 120,000 preventable deaths occurred in American 

hospitals in a single year. While we would obviously prefer that adverse events never occur 

at any hospital, it is unrealistic to think that such incidents can be completely eliminated. 

After all, medical care providers are human and mistakes will occur if only by human error. 

Rather than set an unachievable goal. it is the responsibility of this Subcommittee to ensure 

that when an adverse event does happen, it is properly investigated by the VA in a timely 

manner. Moreover. it is important that the VA establish appropriate risk management 

policies to prevent such events from reoccurring. We must also conduct proper oversight to 

ensure that these risk management policies are being followed by VA medical personnel. 

This is particularly important because of the significant changes that have taken place 

within the VA health care system over the last two years. These changes were designed to 

reduce health care costs and increase the timeliness of care provided to veterans. As the 

reorganization of the VA health care system continues. we must monitor the impact that 

these changes have on the quality of care that veterans receive in VA medical facilities. 

Simply put, veterans deserve to know that they will receive the highest quality of care at 

our VA medical facilities. It is our job to make sure that they do. 

Once again, Mr. Chairman, I thank you for scheduling this hearing. I look forward to 

working with you and the other members of the Health Subcommittee on this important 

matter. 
63 

STATEMENT OF LANE EVANS 

RANKING DEMOCRATIC MEMBER 

HOUSE VETERANS' AFFAIRS COMMITTEE 

TO SUBCOMMITTEE ON HEALTH 

HEARING ON VA'S PREVENTION OF ADVERSE 

EVENTS 

OCTOBER 8,1997 at 10:00 AM 

Thank you, Mr. Chainnan. Today, your subcommittee will 

examine an issue that is of the gravest concern to veterans-an issue that 

goes right to the heart of the quality of their health care-the processes 

and systems the V A system uses to prevent avoidable patient deaths and 

injuries. The cases the media presents to us on medical practice gone 

awry are often sensational and graphic. They cast indelible images for 

all of us-I am touched by these tragic events and join others in being 

outraged over mistakes or clinical negligence that cause them. Some 

indicators tell us that V A has no more ofthese unexpected deaths or 

injuries than other providers. And yet the stories we hear about V A 

providers going through major changes that appear to result in lower 

quality care for veterans lead us to believe it is our duty to assess the 

systems VA uses to ensure patient safety. 

While it is both necessary and appropriate for us to investigate the 

systems and procedures VA uses to manage risk and also for us to 

understand whether VA has more of these events than other providers, it 
64 

would be unfortunate for us to view sensational events as representative 

of the health care VA generally provides. As shocked as we are, we 

need to keep these events in perspective. Every system has its wartsone of our Committee staff members shared an experience with us about 

potentially life-threatening mistakes in her father's care under one ofthe 

nation's pre-eminent health management organizations. WE MUST NOT 

CHARACTERIZE THE VA SYSTEM BY THESE UNFORTUNATE 

OCCURENCES, but rather explore how they happened and ensure that 

VA NEVER ALLOWS SIMILAR EVENTS TO HAPPEN AGAIN. 

The testimony we will hear today indicates that the Veterans' 

Health Administration is trying to deal constructively with these 

distressing isolated incidents. We also have objective criteria to help us 

assess quality and performance. For example, all VA medical centers 

voluntarily comply with the Joint Commission on Accreditation of 

Healthcare Organizations criteria-a mark of quality sought be many 

health care providers. Many facilities have been awarded accreditation 

with commendation. Numbers of reported incidences of adverse events 

have decreased since fiscal year 1994. I also commend VHA for the 

initiative it has undertaken along with the American Nurses Association, 

the American Hospital Association, the National Patient Safety 

Foundation, the American Medical Association, and others to improve 
65 

patient safety. VHA has a long history with risk management and 

recently put in place a revised protocol for dealing with adverse events. 

It appears to address some very complex issues involved in the 

reporting, tracking, and response to so callcd "scntinel events". External 

parties have reviewed their procedures and will tell u~ that VA appears, 

both in policy and practice, to take these events very seriously indeed. 

Some ofthe events we will hear about today could color our 

opinion of VA forever. We could indict VA for its health care quality 

(whether or not it is different from other providers) based on our feelings 

about these events. Or we could move forward to address the systems 

that ensure the prevention of these events are sound and that VA is 

taking concrete steps to correct systematic deficiencies. I believe this is 

the more constructive of the two approaches and I will look forward to 

hearing more from our expert witnesses today to learn how we can 

improve VA's systems. 

Thank you, Mr. Chairman that concludes my testimony. 
~' 

statement of Rep. Maurice D. Hinchey 

House Veterans' Affairs committee 

Subcommittee on Health 

October 8, 1997 

I believe we would all agree that the purpose of the 

Veterans' health care system is to assure our veterans that they 

will always have access to quality health care. It has changed 

and evolved over the years, as it should, but that commitment 

remains its core purpose. 

Today most veterans do not come to the VA for health care, 

often because they do not need to and sometimes because it is 

inconvenient. They use non-VA facilities; the cost is often 

covered by Medicare or by employer-paid insurance. The VA now 

recognizes that it is not always convenient or appropriate to 

provide care at its hospitals, and has begun developing 

outpatient clinics and other means of providing services to 

veterans closer to home. I think the VA deserves to be commended 

for this effort. However, that should not mean that the 

commitment to provide quality health care at its own hospitals 

will be relaxed or abandoned. The VA hospitals should continue to 

provide quality services to those veterans who continue to need 

them. 

Unfortunately, that has not always been the case. I would 

like to call to the subcommittee's attention the problems at a VA 

hospital that serves many of my constituents, the hospital at 

Castle Point, New York. I am concerned that--for whatever reason-

-the quality of care at Castle Point has deteriorated. Many of 

our veterans have lost their confidence in Castle Point, and to a 

considerable degree. in the VA itself. 

All of us who represent veterans in the Hudson Valley have 

lodged numerous complaints with the VA about the situation at 

Castle Point. We have had numerous meetings about it with VA 

administrators, up to and including former Secretary Brown and 

Acting Secretary Gober. I think it is fair to say that we know 

our complaints have been heard, we know that the VA is paying 

attention, but we don't yet know if the problems will be resolved 

in a way that addresses the needs and concerns of the veterans 

that Castle Point is supposed to serve. 

I would like to submit a written statement for the record 

which includes several detailed case histories of serious 

problems that some of my constituents have encountered at Castle 

Point. I want to emphasize that the cases in my statement 

represent only a small sampling of the many complaints I have 

received. I have been disturbed not only by the number of 

complaints, but also by the wide range of problems that have been 

reported to me. They include allegations about misdiagnosis, 

errors in treatment, and surgical mistakes that suggest serious 

incompetence. They include complaints about poor relations 

between doctors and patients, and the inability of doctors to 
67 

communicate with patients--a problem that Undersecretary Kizer 

confirmed in our most recent meeting with him. They include 

complaints about shortages of professional nursing staff and 

allegations that patients have been neglected as a result of 

these shortages. I have heard allegations as well about 

unsanitary conditions, poor maintenance of the facility, and 

misapplication of funds. 

Many of our veterans have expressed concern that the VA may 

be ignoring these problems because it is concentrating too much 

effort on more abstract management issues--most importantly, the 

shift of funding known as VERA. The VA has told us repeatedly 

that VERA would not reduce services or compromise quality of care 

at Castle Point--but that is what seems to be happening. 

Undersecretary Kizer recently told us that there were "notable 

problems" at only four VA facilities that were being 

consolidated--but he did not include Castle Point on that list. I 

want to make it clear that I believe that the problems at Castle 

Point are indeed "notable. 1I 

At my request, as the Committee knows, the VA's Inspector 

General is conducting a thorough investigation of the problems at 

Castle Point, including reports of an increased mortality rate, 

declining quality of care, quality and adequacy of the staff, and 

the effects of resource allocation on Castle Point. We will be 

eager to see that study when it is complete. In the meantime, I 

hope the committee will consider some of the broader questions 

about government management and VA management that this situation 

has raised. 

specifically, these are some of the issues that concern me. Is management of VA health care being driven by computer analyses 

and allocation formulas, while actual day-to-day conditions and 

the concerns of individual patients and their families are ignored? If so, how can this be remedied? 

Does the problem lie with applying uniform rules and 

standards and salary schedules across the country? Is it harder, 

for instance, to find good physicians and nurses in New York than 

in some other places? 

Would the problems be alleviated if there were better 

communication between VA administrators and veterans? Is it 

possible to require clearer communications, as in the regulatory 

process, for instance? We have heard constant complaints that 

veterans' concerns are ignored, that they are not notified about 

changes in services provided, that they are not consulted. 

Finally, and perhaps most importantly, are the problems 

attributable to a shortage of funds? VA administrators have 

suggested this to us on several occasions, and I have asked 

several times if they need more money to provide the services veterans expect and deserve. I haven't had an answer. Congress 

may be at fault here by imposing arbitrary budget ceilings; the 
68 

Administration may be at fault in its budgeting process. I don't 

know. But if cold, hard budget decisions made in an analyst's 

office in washington mean that a diabetic veteran in New York is 

left unmonitored and ignored, then the public needs to know that. 

The VA has suggested to us that this may be the case. We should 

try to find out. 
SUE V..., "'-.tLLf 

69 

(:ongrrss of tbr [ll1ltrb $tatrs 

J!)OIl5r of i'rprrsrnt.ltIUrs 

\[(U.lSIIlI1~tol1. DIC 2l)313-3210 

Statement of Congresswoman Sue Kelly (NY-J9) 

Hearing on the prevention of adverse events in the 

provision of VA medical care 

House Committee on Veterans' Affairs, Health Subcommittee 

Wednesday, October 8,1997 -- 10:00 AM; 334 Cannon House Office Building 

Chairman Stearns, Ranking Member Gutierrez, I want to thank you for allowing me to 

present testimony before the House Veterans Affairs Subcommittee on Health, I cannot think of 

a more important issue for veterans nationwide than the proper oversight of veterans medical 

care facilities to ensure that our veterans receive only the best medical care possible. Today's 

hearing, examining "unusual or avoidable" deaths at V A hospitals must take a strong look at the 

two V A medical centers -- Castle Point V AMC and FOR Montrose V AMC-- in my district. 

F or the past 15 months, we have seen an appreciable drop in the quality of care at these 

two facilities. Keep in mind, this occurred during the preparation for. and implementation of, the 

VA's Veterans Equitable Resource Allocation (VERA) program, which has resulted in a shift of 

$180 million from our New Yark area V A facilities to those elsewhere in the nation. While we 

are not absolutely certain of a concrete connection between these reports and the VERA plan, we 

have certainly seen volumes of anecdotal evidence that suggests otherwise. Plus, Mr. Chairman, 

it was only AFTER reports of aberrant deaths and highly suspect quality care surfaced from local 

veterans service organizations (VSOs), as well as area media outlets, that positive changes have 

been instituted at these t"'.:o facilities. 

In early August, Congressman Gilman and I prevailed upon Congressman Shays, 

Chairman of the Human Resources Subcommittee of the House Government Reform & 

Oversight Committee, to convene a field hearing in Middletown, New York, examining these 

reports of diminished quality care. At this event, we heard from more than 100 veterans and 

family members who shared their personal experiences with those of us on the panel. 

The stories they related were heat! wrenching. One man was admitted to the hospital by 

his wife for treatment of a broken hip, and ended up being transferred three times between the 

Castle Point, FOR Mo~trose .and Brooklyn V AMes, before he then developed an infection and 

died. Another man tearfully described how he had admitted his wife for a seemingly minor 

medical treatment, only to have her die nine days before their 52nd wedding armiversary. 

Similarly, a young woman related how her father was released from Castle Point with 
70 

only a so-called "virus". Yet, two weeks later, she had to rush him to a non-VA hospital where 

her father was diagnosed with a perforated ulcer within hours after he was admitted. However. 

due to his advanced condition, he passed away that same evening, for no other reason than poor 

quality care at our V A hospitals. I would like to ask unanimous consent that articles that detail 

these and other such cases be made part of the record. 

My greatest concern is the reduction in the quality and accessibility to health care that 

veterans deserve, and depend on, through our nation's VA medical facilities. While VERA is a 

three-year plan that officially went into effect on April I, 1997 the changes to the VA facilities in 

my VISN began as early as late September 1996. In that time, my office has been inundated by 

reports of reductions in the quality of care that veterans receive. 

As we speak, the VA's Medical Inspector is undertaking what it describes as a rigorous 

and in-depth examination of the conditions at the Castle Point and FDR Montrose V A Medical 

Centers. Unfortunately, the results of this probe will not be available for at least two months. 

Meanwhile many of my colleagues and I worked to secure language in the FY 98' VA-HUD 

Appropriations bill requesting an additional GAO study that examines the impact of VERA in 

the most adversely impacted regions and reports of reductions in quality care. 

Hopefully, the GAO report and the result of the VA medical inspectors investigation "ill 

shed some much-needed light on some of the unintended consequences of VERA's 

implementation. So while I have no idea what mayor may not be in these reports, I have faith 

that the GAO will conduct a fair and honest accounting of the situation,just as they have in their 

past review of the V A and the VERA program. 

On September 17, 1997 the GAO released a report that outlined the current problems 

with VA oversight of VA Medical Facilities. As background, in my area of the country we have 

the highest number of specialty care veterans nationwide. As you know, speciality care veterans 

are the most expensive to treat, the national price for speciality care is $35,707 per veteran per 

year. In it's September Report, the GAO concludes: 

"Moreover, V A lacks measures for monitoring cbanges in special patient category services, which 

include the most expensive services V A delivers. Monitoring these changes is important because 

of[the VA's new spending plan) incentives to reduce the cost of patient care and because of [the 

VA's new spending plan] incentives to reduce the cost of patient care and because the special care 

population is particularly vulnerable .... some [veterans service areas] are increasing the number of 

patients served in VA.aperated nursing homes without increasing the number of beds or staff 

available by reducing patients' Iveragelength of stay." 

Because of this conclusion, GAO made the recommendation for the VA to: 

" ... improve oversight of (veterans service areas'] allocations of resources to their facilities by (I) 

developing criteria for use in designing [veterans service areas1 resourc::e allocation 

methodologies; (2) reviewing and approving the resulting methodologies. and (3) and monitoring 

the impact of these methodologies on veteran's equitable access to care." 
71 

In response to that recommendation Secretary-designee Gober replied: 

"I believe that the oversight now provided to the [veterans service areas] is appropriate and that 

managements's focus should be on performance outcomes rather than on dictating inputs." 

By overlooking this warning by the GAO the V A is putting the most vulnerable veterans, 

the speciality care veterans, of which I have the highest number, at risk. I ask that you get a full 

commitment from the V A to truly make the V A monitor the implementation of this new 

spending plan as closely as possible. 

Also, in GAO's May I, 1997 report on VA Health Care --Assessment o/VA's Fiscal 

Year 1998 Budget Proposal, the GAO notes several warnings about the implementation of 

VERA: 1) potential risks and vulnerabilities that these changes pose to low-income uninsured 

veterans; 2) that VERA many shift some resources inappropriately because it may not fully 

account for justifiable differences in regional cost variations; 3) that the V A may not have taken 

into account, for example, that veterans are sicker and need more health care services in different 

parts of the country, so that additional case mix adjustments may be necessary to fully explain 

regional cost differences; and 4) that VERA's incentives for lower per veterans costs and higher 

workload numbers could lead to unintended consequences. 

Finally, the GAO report concludes that "Delaying a decision on VA's legislative 

proposals until such critical information is available -- including a plan describing how the 

system will look and operate in 2002 -- may result in a better legislative decision on VA's budget 

proposal. It will also afford V A and the Congress time to better assess how V A's future resource 

needs may be affected by the new decentralized management and resource allocation initiatives." 

It is this very "delay" that I have been pressing for over these past nine months, and will 

continue working for until we get all the answers from the VA. I ask the Committee to take into 

account the conclusions of these two GAO reports. The attached articles are only a sampling of 

what I believe are the noticeable effects of VERA on only two V A Medical Centers in VISN 3 

over the past ten months. 

I thank the Committee for affording me this opportunity, and taking these accounts into 

your consideration. 
72 
73 

1l-'1j ;:-:::.: ~ ~--

~ , . t ',- :-
74 

• 

--I 

J 
75 

Families d 

Heat on local VA hospitals ~lls 

mounts under calls for probe ,: tI· .. 

ribs dE 
76 

'5 ueserlDe deaths 

:4 hospitals 

-;alls for probe m" '-" 
77 
78 

Vt:L IdUt:~. 

a casualty 

of'chaos' 
79 
80 

OurTown. ObItuarlet I I B 

Bu,lnn, I 

WIDNODAv. WOV 21.1"7 

Castle Point 

deaths under 

inv~tion VA Office team examines records 
81 
--

CD 

.. 

(II 

CD 

. --. -

E 

If 

82 

• 

~ 

~ 

• i 

! . 1 , , 

f 
83 

, 

Hospitals 
84 

Thirteen U.S. veterans died 

at the Montrose V.A. Medical 

Center in a live-week period in 

the fall when a plan to streamline nursing-home services 

there went awry, say nurses 

who work althe hospilal. 

And that number - borne au' 

by Health Department records 

- could actually be as high as 

26, nurses charge, if patients 

who died aHer being transferred to other facilities are 

included. 

Nurses charge that the death: 

. occurred when nursing-home 

patients were transferred to ___ n .. ·-·'W..,'=a.lI)iiiillIUI--IlilIIIii----III'W$tiiibili·Iiir!!!iIi-G./' new wards without identification or medical charts. ------------------ .' + story, page 3 
Multiple 

deaths at 

Montrose 

Nurses: 13 vets died 

last fall at VA hospital 

By BETH MULLAlLY St.aft"Wnter 

MO~IROSE - llurteen u.s. veterans died at the Montrose VA Medical Cen.ter in a five-week period last 

~,;n=n~ ~~.tosa~~~~wou:t ~~~~ ~~~ In adcbtJon, DuneS charge another 13 pa!Jents died dur Illg the same penod .alter they were transferred to Castle Pomt or Bronx VA bosplWs La cribca.l condition The 

patients died eIther en 

route or short· ly ~er arrivIng at those facwtJes 

Normally. 

the 200-bed 

nUl"SU1g home 

untt at the hospital sees 

an average of 

one to three deaths per month, SaId 

MaryAnne 

MusumeCI, 

a.::ung direc· tor of the bospltal 

~usumeci 

m.aJnt.una that the number of_Ills during tll.al time penod. Oct .• to Nov. 17 last )"!&r, was '"DO different than any other month ... 

But statl!' Health Department records lndic.ate otherwise 

De.ath certificates ~ the 13 patients who died at Montros~ have been &led with the Health Department's 8Ul"UU of 

Vi~=~WuU: ~~d~reds~~~~bers at ~tontrose said a chaotic reshu1lhng of patients and down- slZtne of staff last October resulted ill the unusually IlJgh morta!J.ty rate 

85 
Montrose 

udr who had twn Uft of tum for about a 

'!'U, but who was now )ocated III • d1I.ferent ward. 

"The aide told me 1M patients and ,WI --., All UPset." "",d loin Nelson "She 5aJd <he _ to ftsit my lather alter her .luIt 

"'clod and found hun so ogIl.Ited that she Il.Iy<!d with him She told ..... 'Nobody 

- him hpn, In this ward They don't 0-wt.at he n~ They don't know they haW' to watch Ius food and water ont.ake· Mel she told _ about All 1M de.ths that had~" 

Cluel Nun. Mujofie O'Connor, who speartIeaded the de¥elapment and impIe - or tho ption to _ patients IUId <'OIl _ ....... moved fnIm her position 

Ibort\y -"1Ioe nouws' .... thre.~ned 

to IiJo. lUI Unfair Labor Pnctite lawsuit 

opiIoII tho hosp~ 1ft Nomnber. nune. J.tic1 She JaUin.d ~ .tth. hoIpi. tal in .naIher job until today. when she will mire with fllllbene6ta. 

Tho reorpaiuboD plan alto called lor a 

reduction ill the number'" .~d nun· ~s in t.Iw ntII'1Iing home unit .". mon! than 

SO pen:ent. fror" 49 to n .• T'hat mt'ant one Rl'I -.lei ev>er _ to.l)ed wan! during the 

day shill No RN s were to be Kheduled to COftr owning and night shilts 

But nunel '§aJd the' plan failed almost 

~tely """_u .. the trans"'r 01 the elderty, mosUy sentlt', patients to new _ toot plac. &0 chaobca1Jy 

MuswneC'1 SAId she was unaware of any 

movtment of patients and staff reductions during that pe-nod because she did not take 

over at Montrose unhJ March of Uutll year: 

Hosp'l.Il adminislrator Jack Gra<\y, who was there in October, did not return phone calls 

UNon olJicials said they protested the 

ption. which ..... cAII.d th. NHCU Re engi· 

neering Plan, bef<n it was implemented Oct. I The plan was developed in rrsponse 

to <XpOCt.d cuts in th. VA budgeL which were approved by Congress at the end of September. 

In memo! to O'CoMor in JuJy and September, the nurses expre.sed (ean that 

moving the patients and cutline stair would _tpali.ntc ..... 

In • July 3 memo to O'CoMor, a union chief steward _. ",.he drutlc cut in 

prole.,ion.1 care .nd supeni.ion will unpact on quatity patient c.... and the woriDnC condiIion. 01 the employees." 

Th. union •• ked the administration not to implemenl the plan without input from nune. on patienl-aJ1! Iuuea. 

In • Sept. 'memo to the union, O'Connor wrote', '~ur conceml Ire appreciated, 

however, .. noted there were apportuniti .. available fur union inpul." 

Th. plan wa. finalized Aug. 30 and went into effect Oct. t. 

~ palienls di.d, union offici.als began 

coUecting data on the deaths. 

". ,f j ~ ) I II 

The Times HCfald Ric

"We went down to the mo

the records," said one 

Nun •• provided The Times 

with tht' documentation tha

clauns They also kept an 

01 pllientlran.'en 

The union officials ,<aid 

Irwin Gerard, commi!i5ione

Mediation and Conciliatio

with hospital officials in O

in November to protest th

ward reusignmenh. 

"The mediator recomm

staffing a.rrangements be 

mal," said one union officia

G.card ,"id the diapat

amlClbl)!. ~ • result. nun •

olfered the option 01 return

pati.nts. The planned sta

night shift did not go into .

rat. hi •• ince dropped to n 

.. said, 

Nunes laid O'Connor wa

h.r polition shortly Iller 

• gree .... nt and look • job a

_ ",,~s alIai ... tt

lew month. unW her retire

O'Connor declined 10 c

circumltallc:.1 01 her job ch

m.n~ and.he referred All q

pital oIIIeiaIs. 

Musumeci said that " •• 

w" her choice to I .... her 

MUlumeci also disput

clainu that 13 veterans die
87 

L./(';ULllv UIUIII\"U 

on VA cutbacks 

Above, • 'IIn II 

the Monttn. VA hOlpftal .. Iut .. 

Am,rICI" 

vet.,." •. At I'". Carman QrUIO'II 

01 .. _.""" 

W "rud ••• __ 

In World 

betng trlntf'."ed 011' of th. VA hOlplta' Into , 

prl."tl nur'lnQ hom,. H, had Alzh.lm.r', dll· -. ~~-==~~~r!: ~~.:.:-.. 'to :.!:::!"" tIIin\J. Aad tbe, !be _ Iwlhllbud .... tit be lad aIGwb' bec2UM he =-:,=.,., saa::-:.~~.=mt! pul'~b:lbeliabil-...cIL 

., lUI ... • .. aid ...... GruiDIi. -..e', ill pod health. 

=~~~ri!llrinLBejalt"'tllbe~ 

Rer 1NItIud'. C'DCIIIitioa dda'Ion&ed ~ liter the 

I:rm.ter.H'e:.~biI'" H.~ ~he cIe4 BIll Riebl drqlped tam I~ to 

.. ~~~~~.,..".~.~ wtx.e .. ..., trw. -' AlIDo ~ ttMI' ... It IIurt ::,:::!-,..,1111 lit. AIIId ct.; ... , Ute rime 

an. 

..=-,..... -~c:'a: tile acca.t of .. .. '"::" 

.,.. ....... 

~ =, "em- ~.-= =., bud6a no lied III tblt VA 

Uif-~~: -: ~ :a:::,::r ~t 

=...-..:z:.:.~~~~~~ 1Ut1llil ......... 
88 

Tales of neglect rise at VA hospitals "Within. w •• k. th.y lo,t hi. 

t •• th .nd .1 •••••. "I. co .... itlo" ..,.nt fro," b.d to wo ... . WIthout hi. t •• th. he oould,,'t •• , 10114 •. HI •• "kl ..... 1 .... to 

the pol"t wh ••• I could b., •• y put aock. 0" hlm:-

-Mdf\lMeNUI •. 

'pt-.aklng of M' '-Nt w.1!,.~ 'tiPPY" P,.,..d.rg ... 

v--.. to rally eplnat cuts lIIIIDI..ftOWIf-v ____ .. ~ 

:rt~~~...:_vc:"·~ 

tr:=:..o::..~~a-r:.; .. 'ftw_WII".~"I~ ~~::::s- ~ uboClac..de r __ .-wi 

~~.,o.~VefInIUI~"--bu 

=.:..~.:=:~~...::~ ... cuth".,tlltll .... 

,....._~U.liIritIt;.a-..-'p&enty1ll 

.. lIlT r .... ~~bGn, QIJ" 0WIcaII ,\ tc-,m. 
89 
what they say 

~ 

"~We ha .... e.,.full., 

ud'I I3H It\i:I hft bMt'I brougf'I: 10 DlJf .ft~Don 

dUrI", ,h ... put f ... .., 

m~ ....... .,hm.cl'a. ou,ef~d~~ .. or .. alar,ns. II 1I, .. t. ".,v ~1IO,....,ltGriaIof 

Door _Ihor'_",,_ UN, I _ani yOU to 

:X::,~:;~ ,.eivwd ... tift, CM. mil 1'IIlicn ........ w.c,w, ... _ ........ aI. 

famIy ~ who .. Ie. 

purpa. ., .... ~ cat. WId ...,....,.. at .... ,....., _ Owr __ '-umod'" boII_ "'"' ~ tA .... brMr., ~ Ie .... ~.' 

_MrtYtlUYA_ ---. 

90 

T.r\"~ ~\t. i<''''ll) 

iCl c C'R.t> 

~, /5 ,Iq, =I 

..".. mp~ gf vet4 ha ,,(Nt piaed ~ 

9Jn.t 

_ ....urrw. Ind " .. 19_Mt: sale tor ~ Iund1 

",. 

....... 

.... _---. gf ~ ~ ,rd nal\g d.-.N It VA halo • ... lit c.h Potnt .fICI MonIroso ., not YrnQIoie 10 Ito\; 

Hudson 'VI/!~. W. " ft 0M.;gn '" V~· d,lt5 ""' .... ~ 5imIl, .-.g.Uot'w frwn .... m ... e wd f.rnTa frO'"" ON' _ of .,. 1RiWe. Ind dng ....,..." If'Id upnale Now 

Y""'ond.".~ ..... Ywtwww.rldthe .. kNwdor-. .... cr~~ .nd f"rl\,: VA hospiaI • ...,.,.. ~ .. btllCOO or hoQo. Now, ~':r . ........ .. bWJg ..." • ....., for *W ...., once t;d. lor ~ .. 

..",. ~ !hit 'we wa;nt b ._ CIr8 of ,04/ eol'O\lno 

frQTt .,.. "A ill fer!TlOl"ty ....... ~ hanj 10 ..-OW'. Vet.n ...... 

..-.d ...... .."... ~ "'. tt. •• In \IW«I"I ~Ct "T"ttII, befi ..... '&he' aM V".-.". Alt.-In. It .... t wh('ll1 .: 

~1O~~.""~-" __ .: ~0l.l''7:.'!'==:':;.'' ftaday. ,"IY -_ ....... ..... --'-c-ty 

_MV_A_ 

l.,.twt~~~~ I ttl PoUI1 refJecq I.h. com· 

1 ~,... .. an:l fOf o.l;.n! 

NW.,...,r;rf.~ 

~u • ......-r"'ppo. 

:::. t: :':';1 ~~~"'; Nquo.drlg 1ft -,,/TIk'I.,;1"'1' 

with. physici.". All.;: I 

........ ".,~ 

I III'" cIcIaDr ... INd. ~.; 

I ===.~"':.~qC~; I .... I .-: ""OU loot rll'1(" 

10". I dan't _ ........... MIt.........,.... nGI ~i; lrlP!L! 

to til m. onCI by uposIne me to C8tcl,..."e"ic "'~tI ,I 

ci6aW .. "IIct~pn:Ipa'~~ .... d""C'I"II;';'''' ..,."..~.III!ICD'Mf."., .. 

.. ....., .... e.-e • 

......... ,.." 
Activist 

petitions 

for probe DwIao-~ .• _' ....... _ ......... a_VioI· __ 10_\!::,,:_1 ............. ., __ 

..... 

~--.. ... -. ,-........... --", ....-~..-....... ...... • ",.. u.. ......... C.-.I ..... 

_~""'-'nl_ a.p-. __ 011 ....... _ .... _-.r_ ......... ... _ ...... __ Ithe 

--........ 

~:::. :t~I;:-.! 

-"',""--.. _. ...... ..... rh _ or *"" _III 

AIIlII -thel • ....." eft c ...... lie ........ 1oIl ond Il1o npooot bId __ 

_ .. II ....... · .... InC fur 

...... , .. _,....,...., ..... '- ........... n<)'I/00~_ .., .. I.,.,., c ......... _ ........ 

IIMftst ... ....... whaI. r ...... 

_l ..... 1d. 

• HPFpltal "","icr. and Wdvt NIo _ .. ~ " 11"010", IIIId ..... nnl ... ., .......... ."... ~ _ .nd quoIif.y 

of .. _ ~ .. VA ho.,I" bot -" Ie _ ...... _ ..... - ____ cIepubik. 

what they say 

''W. u. 'or • comple.e in" .. t.gallon by 

.. ~Ior genor" om" ~" ~DPoented 

mdcoonclent council into .11 ve •• ' .... ,eeio* oIfIcu aftd ccmp.n •• tlon doclor. In lhe U"".d 51 •••• to det.rmlna 

wt1Ich ..me. -"' docloU arc in tho busi· 

fMln of ob.tructing veterent 'eg_I""" •• d_1 TIle .... ...,.,. phIIooophy behind 

.... ".. • ..". ." ~, COM.uno" i& .he 

..... '" power occur .. hlrn It\ftr. i. no • v', .... •• chech .,ut t-.le"c •• l The ", ••• ,ena edmin,eUe,jon aho"ld b. , ......... 10 ,...1)Ond cOor,.,t'¥' to .. I .. .". 

dMN ..... 10 d-V- or en In'e ... 1 pen-

.tty ...... be II"ftDOMdl Unte.. the,. ar • ~ 'or ..... nlc:.iency IIftd ett.l,ucdon of ce. .... 1 v.t.r.ne will,. contin.,. '0 til • 

tr_ .... un;v."", 

"o~piU.' .crvil;OI a"d budoet cut. s_ be do ...... 1Md by .... quollty 01 

•• f •• e.1I r.nd.,.d. v.I.,an n •• d. end K(eufbili" of • ." .. icn. nO' by ,i •• or pofhlc.el loullonl V ... r.n •• hould no' 

• t •• " whil. ou, .m.n., ho_"itdl. a,c 

..... ~ tf' ""0' of hug_ tnOnft~ 

'''hle 1n"'lutlona wh.r. our chanr.: •• of 

'''''''1I1ng QI ... nry r.er. •• gr •• 'y dlmin .. ,.twd, 

I •• S ""51 "rnr 'Ot veta'en, to unit. aM 

fit"'l 'ow the Iusllca. '_pee,. and cttgnt'V 

_w.h they d .... ",., " ~ do "01 (line 0\1, 

vo,e., .. nd •• oreis. our "ghls, ,,'env .foIOn ww will .... k. up tn ftnd """ dn "hi 

I .. ",. '''yl hi I", "",ow tt,. wo,tt't ,".t 'Mt 

wIN not "go QUtC'lIty Nl'O .h .. night" _hilt' 

tho "e_ans Admanl.I, •• 'con contlnu ... to 

r"'p-'u". tnJu.hce In lh_ h., ... 0' ,,"an 

om: of "'Y' comb., .... '.,.".1 

la' WI .C8nd up .nd .,. cOlln •• d tn ,t1l. 

" .. ",.1 Lei W5 dt:m~nd an 'n'"'e,tig.tlon by 

Iha msp.dor G.n.r.1 end an ,nd.P."dttul 

counCIl lod.y. 

l .. our erv fof JU~';U' rin

lartd untif ou, ,",ole.s ., ..

Ju.1tce II'Id ' .. ~ct which 

to our Yef.r.m. 1'1 ftnl" 

ohern' 

The llallto 1\;I.on is no .... l 

_"

V ........ V.c.n

.. c:-..... __ 

'''WI'h C •• II. Point. 

0-"" tM la .. y.a,. I 

' •• 1 .v.rything " •• .on. downhill. I" AIDri' ..... , .... tnt. ..rl •• of t •• te. the d_f., told .... h.'d 

be in touch _1h ma 

wh." ... '01 1ha , ........ tl·snow 

A~ MIl I Mvan', h •• rd on_ '1,nvlG 

-. Temorrow. I will Wlnd..- 

egMt to 1M VA end .......

COfi'W ....... h".. ,.&1 r-.u

luw.t .. IIIII'hIn the _wer 

··W. e_n', (md mIt ,iftt.·, 

........ did IhI'lwK. 1M _ 

-R ......

_v.

"I wi' .elndt:d .. 10 Munff

tal .. isle MII\IIIlf'( fill "~Ai".c,

rlort' In Ot:lob"r 1 tIJfi A hos

,va,', r .. ponalbthty II 10 m

the palion' ge,. tho best 

Ihlt .If.tv ,,"'«IIII.ils, Ihat 

OCC-U" ...:;, 

Whit ••• rvlng th.rfl, It ha

.hlt Moollv'. ,oU1lnelv in
Anger and sorrow mar

.,_II.T_ 

ne --doon to the WoIlItiII 

c.....ity c .... ." I"", .... n 

.. .., ... '.he \'d.I!~, "'" IIIl'e Iftd ,..,.". writtm _ 

....unc -.. ...- into 

....... 'T1Io7 ,........ pliot .... Md """,. 

...... -...... -......... oIIItn ill wIIftI<Iwn. '-...... 

.-.-........... jodi. 

.... ".,. como<Il_-" .. wIoit:IIRft __ oI 

..... lrIdlMitplity 

'T1Io7 set th." ,.nil .. the _ \IIIIa AI ..... Nt locAl 

... ",lIen of C""",",. Reps 5uo 

Kdy. BellJU1in Gilman and 

Maurice Hinchey, At another sal 

admini5tntorfi "I thf' federnl 

Department nI Veterans AlJ'il1J"!I: 

Por mOIl of the day, the velcrans Ulerwd and It't'fhc!d Thty 

yeUed angrily when they hean' 

_hat they thoug,hl w.s a lie. Thry <tapped _. they heard wh.ot 

th.,""""ht_.....,." . 

They hod lhinp to .. y . - "",,"I 

care not recciYed It Callie Pomt 

Medical Center, about _ucntivp. 

IIodorw and ""en.itive slafh'~, 

Some prailed the Gpfl1llion and 

the employt'l!5, but lhe~ wrrr 

""",,_negri.! 

OllUlhters !!pOk.. nf ("I tw",; 

d)ing too ~onfl One man told the 

(onurutlre Ll1al he had asked his 

sufferi~ \Ylle In ~o ItI.a VA hoSpl 

tal She dld and !lh~ died. be said 

He 11 ~hnYli re~1 .... hat he did, he 

"aid. II!I has vOl('e brokr 

, .... u •• In ."., wtth q ... 'UO .. 

"On March 24 f)f tiw> year, my 

~dfatber WYnl to Ca&lIe POint 

Ind was Jut home with a sncalled virus," Cindy Trimble of 

Glenham.said. "We bad him tl'UlSIorred to another hospital. H. b"" • perforalod uk .... 

"By that time, there wu nothtng 'hot cooId be done H. died 

t wn day. latrr In figurine mortali· 

ty rail'S, dn<'~ the VA count ~e 

patie

dU'd 

tal' 

after 

~ceM

from 

A

ut P

r.the

rom

lilt! t

d(lt.i.

would

"W

fathe

hoor

died 

htp. 

,"y~"
93 

HARVARD SCHOOL OF PUBLIC HEALTH 

Depanment of Health Policy and Management 

Lucian L. Leape, M.D. 

Cliff Steams 

Chainnan, Subcommittee on Health 

Committee on Veterans' Affairs 

U.S. House of Representatives 

335 Cannon House Office Building 

Washington, DC 20515 

Dear Mr. Steams: 

October 3, 1997 

EnClosed are the materials for my testimony scheduled for October 8, 1997: 

• A camera ready copy of my testimony 

• My disclosure statement 

• MyCV 

• 150 copies of my testimony 

• A diskette with copies of my testimony in ASCII and WordPerfect fonnats 

I look forward to the opportunity to discuss these issues with members of your committee 

Lucian L. Leape, MD 

677 Huntington Avenue Boston, Massachu ..... 02115 617432-2008 Fa" 617432-4494 
94 

TESTIMONY OF LUCIAN L. LEAPE, MD 

Members of Ihe Subcommillee on Heallh of Ihe Commillee on Veterans Affairs: 

I am Lucian L. Leape, MO, a professor at the Harvard School of Public Health with a primary 

professional interest in improving patient safety in health care through reduction of errors. I come 

before you to discuss the problem of accidental injury to patients in our health care system, 

particularly among hospitalized patients. 

First, it must be said that the rates of errors and injuries in hospitalized patients are far too high. In 

1991 the Harvard Medical Practice Study reponed that 4% of hospitalized patients suffered an injury 

due to treatment and that two-thirds of these were caused by errors. Extrapolating to the nation as a 

whole. we estimated that approximately I million Americans are injured by errors in treatment in 

hospitals each year, and that 120,000 people die as a result of Ihese injuries. This is 3 limes Ihe 

number who die on the highways, and 1000 limes the annual airline falalily rale. The cost of these 

injuries in 1984 was eSlimaled al $33 billion. Because Ihat sludy was based solely on a retrospeclive 

review of medical records we Ihought our findings represented a lower bound. Indeed, recent sludies 

by olhers suggest the rale of injury caused by errors might be Iwo or three times what we found. 

Barriers to error reduction 

It is evident Ihal hospilals and olher heallb care organizations have major deficiencies in Iheir ability 

to insure the safety of patients. Why? The reasons are complex: 

I) Lack of information. Studies have shown that only 2-3% of major errors are reponed in 

hospital "incident report" systems. As a result, most hospitals are unaware of the extent of 

their errors and injuries. The reason for low reporting is that personnel are typically 

punished when they repon errors. Because of this punitive environment workers tend to 

repon only those events that cannot be concealed. 

2) Health care organizations accepl low levels of performance. For example. a recent repon of 

screening rates for breast cancer in HMOs found mammography rates for women at risk 

varied from 30% to 90%, rates of performance that would be unacceptable in other 

industries, panicularly high-hazard, "high-reliability" industries, such as aviation and 

nuclear power. 

But, despite the evidence to the contrary, health care does not think of itself as a highhazard industry, much less a high-reliability industry. In pan. this reflects the 

preoccupation of doctors and nurses with diagnosis and treatment, but also the traditional 

view of many providers that health care is so extraordinary and so socially useful that some 

slippage or inefficiency is an acceptable by-product. As a result, hospitals are incredibly 

inefficient, and tend to accept inefficiency as a normal component of health care delivery. 

3) Hospital personnel (as well as most of the public) tend to regard errors as evidence of 

personal carelessness, the failure of the individual to meet the standard of perfect 

performance. Human factors specialists and high-reliability industries reject that view, 

recognizing that errors almost always result instead from defects in the systems in which 

people work. These students of error have taught us that errors are not accidents occurring 

out of the blue. Errors have reasons - and those reasons are very rarely carelessness or 

malice. Human beings make mistakes because the systems, tasks, and processes they work 
95 

Lucian L. Leape, MD October 8, 1m 

in are poorly designed. Two medications with similar names or with similar labels are an 

accident waiting to happen. Working double shifts or having twice as many patients to take 

care of is an accident waiting to happen. We all know that fatigue causes errors, yet we 

work our doctors. nurses. and pharmacists long hours and give them extra patients to take 

care of. These are the kinds of systems failures that underlie the apparently simple errors 

that people make. These are the kinds of systems failures that must be corrected if errors 

are to be prevented. Hospitals don't think of errors as systems problems. 

2 

4) Our methods for eliminating errors are ineffective and misdirected. Because of the focus on 

individuals and on carelessness as the cause of errors, hospitals and health care organizations 

rely almost exclusively on training, rules, and punishment to prevent errors. We insist on 

perfect performance and punish people when they (inevitably) fall shon. 

Unfortunately, human beings. even careful, conscientious, caring doctors and nurses. 3re 

incapable of perfection. Everyone, even the most careful, makes errors - every day. 

Punishment for errors merely acts as an incentive to conceal. Ironically. rather than reduce 

errors, punishment increases them because it makes it difficult to uncover the underlying 

causes of errors and remedy them. The paradox is that the single greatest impediment to 

error prevention is that we punish people for making them. 

High reliability industries, such as aviation, air traffic control, and nuclear power, learned 

long ago the fallacy in this perfectibility approach. They also believe in training, rules, and 

high standards, but they don't rely on them. They look to their systems. 

5) Hospitals and health care organizations also lack clear incentives to do something about 

errors because patients, doctors. and insurance companies bear most of the costs of medical 

injuries. In truth, of course, errors, like any process inefficiency are costly for hospitals in 

terms of rework and prolonged hospitals stays by injured victims. But these have been 

largely unrecognized costs. 

As a result of these factors, hospitals and health care organizations have not made error prevention a 

corporate objective, or, in most cases, even put it on the agenda. We have not made safety "job one" 

in health care. But, even if our health care organizations were to do so, our society imposes some 

formidable barriers in the regulatory and legal systems that make changing our approach to error 

prevention difficult. 

Public approaches to error prevention 

The public approaches to medical error, which are often mirrored within hospitals, are based on 

inspection, incentive, punishment of offenders, and controlling outbreaks. These approaches are 

neither modern, scientifically grounded, nor powerful forces for improvement. Worse, they add cost, 

reduce information exchange, produce fear, and cause their own hazards. 

• Both state agencies, such as depanments of health and boards of registration in medicine, 

and private regulators reinforce the "blame the individual" approach to error prevention. 

They call for identification and punishment of the responsible person. 

• The media reinforce this focus on finding the person responsible - heads must roll. 
96 

Lucian L. Leape, MD October 8, 1997 

• The ton system focuses on the individual who made the error causing an injury. assuming 

that punishment will make that person less likely to err again. The concept of a systems 

cause is rarely considered. 

What needs to be done? 

The problem of errors in health care is now becoming recognized as a major health quality issue. It 

will not disappear from public concern. Sentinel events reponed in the media focus the attention of 

oversight agencies, consumer groups. organized medicine, managed care organizations. and health 

care executives. A body of research on the prevalence and etiology of medical error has emerged, 

informed in pan by the experience of the aviation and nuclear power industries, and by students of 

human factors engineering. Health care organizations are beginning to respond. Managers within 

health care organizations are developing tools and techniques for the identification and prevention of 

errors, including sophisticated information systems, pharmacy tracking systems, practice guidelines, 

and quality improvement methods. These initial effons are impressive - and reassuring that the 

private sector is taking up its responsibility. Some notewonhy initiatives: 

• In October, 1996, under the auspices of the American Association for the Advancement of 

Science, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the 

American Medical Association (AMA), and the Annenberg Center, and with sponsorship by 

a host of health-related organizations, and others, a major conference was held that brought 

together people from diverse backgrounds, industrial and theoretical as well as healthrelated, to exchange information and ideas on how to prevent errors in health care. 

• The AMA has launched a major initiative, the National Patient Safety Foundation (NPSF), 

dedicated to error prevention through research, education, and the dissemination of 

information. It can serve as a clearing house for information and a stimulus for the 

development of new knowledge. The NPSF has a national board of directors and has 

already supponed some innovative approaches to error reduction while developing 

information resources about what is being done throughout the nation. 

• The JCAHO has revised its reponing and examination procedures to reflect an emphasis on 

systems repair rather than punishment as a means of preventing errors. 

• The American Society of Health-System Pharmacists has long led the efforts to reduce 

medication errors. Together with representatives from the major health care organizations 

and the United States Pharmacopeia they have published a guide to imponant systems 

changes that all hospitals should incorporate to reduce medication errors. 

• The Institute for Health Care Improvement recently carried out a collaborative effon to 

reduce adverse drug events due to errors. Fony-one hospitals and health care organizations 

participated in this year long effort: a second collaborative is about to begin. 

3 
97 

Lucian L. Leape, MD October 8, 1997 

In the public sector. state Departments of Health and Boards of Medicine are re-evaluating their 

procedures to focus the attention of hospitals and health care organizations on systems problems. 

while still maintaining vigilance to identify and remediate individuals whose performance is 

dangerously below the acceptable level. 

4 

At the federal level. the Veterans Health Administration has developed a Handbook for Risk 

Management that incorporates some of the new insights into error prevention through systems change. 

This new system for identification. reporting. and analysis of adverse events has the potential to 

greatly expand our understanding of (he scope and causes of injuries and errors in health care. It also 

represents an enhanced level of accountability from which all will benefit. This proactive approach 

can serve as a model for all health care organizations. public and private, as they seek ways to more 

adequately take responsibility for patient safety. 

Future directions 

Much remains to be done. however. We have just begun what may (and should) turn out to be a 

major overhaul of how we deliver health care. Some of the questions that have to he addressed 

include: 

I. What is (he best way to create incentives for hospitals and health care organizations to make 

error prevention a major strategic objective? 

2. In the short-term. prior to implementing the needed major systems reforms. how can hospitals be 

motivated to implement lesser changes that are effective in reducing errors? 

These measures. which are not in place in most hospitals. include such things as bar-coding 

of drugs and patients. use of computerized order entry. the use of protocols for emergency 

treatment and for complex drug therapy. such as chemotherapy. 24-hour presence of a 

pharmacist. and limited work hours. 

3. How can hospitals and health care organizations be motivated to eliminate punitive reporting 

systems? How do we make reporting of errors "safe"? 

4. What measurement and monitoring systems should be developed for tracking errors and 

effectiveness of corrective measures? 

We lack good measures for error detection. analysis, and tracking. To be effective for 

improvement. measurement systems must be designed to gain knowledge. not to administer 

punishment. 

5. How can the necessary report gathering function of regulators be modified to become a force for 

error reduction rather than an incentive for error concealment? 

6. How do we educate health care professionals. both students and established practitioners. to help 

them understand. accept and act upon modern concepts for error prevention? (Including such 

things as teamwork. effective communication. and application of human factors principles) 
98 

Lucian L. Leape, MD October 8, 1997 

7. How can we facilitate the exchange of infonnation between health care organizations and other 

industries that are more expert in error prevention and system fe-design? 

8. Should hospitals and health care organizations instead of physicians be held responsible for 

adverse events (including compensating patients)? If so. what type of legislation is needed? 

9. How can the perceptions of the media and the public be changed from the idea that errors are 

best controlled by blame and punishment to an understanding of the central roles of systems 

redesign and corporate responsibility? 

5 

A tall order. But we are off to a good start. And. with typical American initiative. many innovative 

approaches will be developed in the next few years. Making health care safe is finally on the national 

agenda. 
99 

HARVARD SCHOOL OF PUBLIC HEALTH 

Department of Health Policy and Management 

Lucian L. Leape. M.D. 

To: Subcommittee on Health, Committee on Veterans' Affairs 

Date: October 3, 1997 

From: Lucian L. Leape 

Subject: Federal support and conflicts of interest 

I hereby declare that I have not received any funding or support from any Federal grant or 

contract related to the subject matter of my testimony within the past two fiscal years. Nor 

am in the employ of any commercial enterprise that makes or distributes health related 

equipment or supplies. 

Lucian L. Leape, MD 

677 Huntington Avenue Boston, Massachusctt~ 02115 617432-200S Fax: 617 432-4494 
100 

Lucian L. Leape, MD 

Lucian L. Leape is a health policy analyst whose research has focused on quality of 

health care, particularly unnecessary surgery, the development of practice guidelines, and 

error prevention. He is currently Adjunct Professor of Health Policy at the Harvard School 

of Public Health and a member of the Health Sciences Division at RAND. Prior to joining 

the faculties at Harvard and RAND, he was an academic surgeon, most recently as 

Professor of Surgery and Chief of Pediatric Surgery at Tufts and the New England Medical 

Center from 1973 to 1986. 

At RAND, Dr. Leape has directed several studies of overuse and underuse of 

cardiovascular procedures. At Harvard, he participated in the Medical Practice Study of 

malpractice and the Resource Based Relative Value Study. His experience in the Medical 

Practice Study led him to investigate the causes of error in health care practice and to carry 

out studies of adverse drug events and their underlying systems failures. He is currently 

leading the Institute for Healthcare Improvement initiative in error prevention. He has 

served on the AHCPR Health Services Research Review Committee, the Institute of 

Medicine Committee on Technological Innovation in Medicine. and the PPRC Access 

Advisory Committee. Dr. Leape is a graduate of Cornel! University and Harvard Medical 

School and trained in surgery at the Massachusetts General Hospital and at the Boston 

Children's Hospital. 
ADDRESSES: 

Office: 

Home: 

PRESENT POSITION: 

101 

CURRICULUM VITAE 

LUCIAN L. LEAPE, MD 

Dept. of Health Policy and Management 

Harvard School of Public Health 

677 Huntington Ave. 

Boston, MA 02115 

(617) 432-2008 

12 Laurel Drive 

Lincoln, MA 01773 

(617) 259-9620 

Adjunct Professor of Health Policy. Harvard School 

of Public Health 

Consultant. The RAND Corporation 

PERSONAL INFORMATION: 

Born: November 7, 1930. Pittsburgh. PA 

Social Security No. 

MILITARY SERVICE: Lieutenant (j.g.), U. S. Navy (1952-55) 

EDUCATION: A.B. Cornell University. 1952 

M.D. Harvard Medical School. cum laude. 1959 

POSTDOCTORAL TRAINING: 

Internship and Residency in Surgery 

Massachusetts General Hospital 

1959-62; 1964-65 

Resident in Pediatric Surgery 

Boston Children's Hospital, 1962-64 

Registrar in Pediatric Surgery 

Alder Hey Hospital 

Liverpool. England. 1965-66 

Health Policy Fellow 

The RAND Corporation. 1986-87 

xxxx
Lucian L. Leape 

CERTIFICATION AND 

LICENSURE: 

102 

- 2-

Licensed in Massachusetts (# 265XO) (1959) 

National Board of Medical Examiners (1960) 

American Board of Surgery (1967) 

American Board of Thoracic Surgery (1967) 

Certificate of Special Competence in Pediatric Surgery. 

American Board of Surgery (1975). Recertified. 1984 

PREVIOUS ACADEMIC AND 

HOSPITAL APPOINTMENTS: 

Instructor to Associate Professor of Surgery. Senior Surgeon 

University of Kansas School of Medicine. 1966-73 

Professor of Surgery 

Tuns University School of Medicine 

Chief of Pediatric Surgery 

New England Medical Center Hospital. 1973-87 

AWARDS AND HONORS: 

Society of the Sigma Xi. Harvard University (1957) 

Alpha Omega Alpha. Harvard Medical School (1958) 

John and Mary R. Markle Scholar in Academic Medicine. Kansas 

University (1968) 

EDITORIAL BOARDS: Associate editor. Journal of Pediatric Surgery (197 I - I 987) 

NATIONAL COMMflTEES: 

AHCPR Study Section. 1990-92 

10M Committee on Technological Innovation in Medicine. 1991-

PPRC Access Advisory Committee. 1992-

PROFESSIONAL SOCIETIES: 

American Academy of Pediatrics 

American College of Surgeons 

American Pediatric Surgical Association 

American Public Health Association 

Association for Academic Surgery 

Association of American Medical Colleges 

Association for Health Services Research 

Boston Surgical Society 

British Association of Pediatric Surgeons 

Lilliputian Surgical Society 

National Wilms Tumor Study 

New England Pediatric Society 

New England Surgical Society 

Roxbury Clinical Record Club 

The Society of University Surgeons 
103 

Lucian L. Leape 

Recent Publications 

I. Leape, L L, Unnecessary Surgery. A Pew Memorial Trust Policy Synthesis: 7. HSR: Health Services 

Research, 1989,24 (3):351-407. 

2. Leape, L. L., Park, R. E., Solomon, D. H., Chassin, M. R., Kosecoff, J .• and Brook. R. H.: Relation 

between surgeons' practice volumes and geographk variation in the rate of carotid endarterectomy. 

New Engl J. Med, 1989, 321:653-657. 

3. Hiall, H. H., Barnes, B. A., Brennan, T. A., Laird. N. M., Lawthers, A. G., Leape. L. L.. Localio, A. 

R., Newhouse, J. P., Peterson, L. M., and Thorpe, K. E.: A study of medical injury and medical 

malpractice. An overview. New Engl J. Med, 1989,321:480-484. 

4. Leape, L. L., Park, R. E., Solomon, D. H., Chassin, M. R., KosecofT. J., and Brook, R. H.: Does 

inappropriate use explain small area variations in the use of health care services" J AM A, 1990,263:669-

672. 

5. Leape. L L. Practice guidelines - an overview. QRB. 1990; 16:42-9. 

6. Brennan. T. A., Localio, A. R., Leape, L. L., Laird, N. M .. Peterson, L., Hia!!, H. H., and Barnes, B.: 

Identification of adverse events occurring during hospitalization. Ann Int Med, 1990, 112:221-226. 

7. Brennan, T. A., Leape, L. L., Laird, N. M., Hebert, L.. Localio, A. R., Lawthers, A. G., Newhouse. J. 

P., Weiler, P. c., and Hia!!, H. H .. Incidence of adverse events and negligence in hospitalized patients: 

Results from the Harvard Medical Practice Study I. New Engl J. Med. 1991,324:370-376. 

8. Leape, L. L., Brennan, T. A., Laird, N. M., Lawthers, A. G., Localio, A. R .. Barnes, B. A., Hebert, L., 

Newhouse, J. P., Weiler, P. c., and Hia!!, H. H .. The nature of adverse events in hospitalized patients: 

Results from the Harvard Medical Practice Study II. New Engl J. Med, 1991, 324:377-384. 

9. Leape, L. L., Brennan, T. A., Laird, N. M., Lawthers, A. G., and Hia!!, H. H .. Adverse events and 

negligence in hospitalized patients. latrogenics. 1991, 1:1-5. 

10. Brennan, T.A., and Leape, L. L.. Adverse events, negligence in hospitalized patients. Results from the 

Harvard Medical Practice StUdy. Perspectives in Healthcare Risk Management. 1991, 11:2-7. 

II. Brennan, T. A., Hebert, L. E., Laird, N. M., Lawthers, A., Thorpe, K. E., Leape, L. L., Localio, A. R., 

Lipsitz, S. R. Newhouse, J. P., Weiler, P. c., and Hia!!, H. H .. Hospital characteristics associated with 

adverse events and substandard care. JAM A, 1991, 265:3265-3269. 

12. Leape, L. L., Hilborne, L. H., Kahan, J., Slason, W. B., Park. R. E .. Kamberg, C. J .• and Brook. R. H., 

Coronan' Artery Bypass Graft A literature review and ratiolls o(apJl[Oprjaleness and Decessit)'. Publ 

JRA02. Santa Monica, 1991, the RAND Corporation. 
104 

13. Hilborne, 1.. H., Leape, L. 1.., Kahan, J. P., Park, R. E .. Kamberg. C. J .. and Brook. R. H., 

Percutaneous Transillmjnal CoronDey AnaiQlllasl)' A IjternlufC review and ratjngs ofappmprjateness 

and nece."ily. Pub!. JRAOI. Sanla Monica, 1991, the RAND Corporation. 

14. Leape. L. L.. Unnecessary surgery. Ann Rev of Public Health, 1992, 13:363-383. 

15. Johnson, W.G., Brennan, T.A., Newhouse, J.P., Leape. L. L., Lawthers, A.G., Hiall, H.H., and Weiler, 

P.c.. The economic consequences of medical injuries: Implkations for a no-fault insurance plan. 

JAMA, 1992, 267:2487-2492. 

16. Leape, L. L., Park, R. E., Kahan, J. P., and Brook, R. H .. Group judgments of appropriateness: The 

effect of panel composition. Qual Assur in Health Care, 1992.4:151-159 

17. Ballard, D. J., Etchason, J. A., Hilborne, 1.. H., Campion, M. E., Kamberg, C. J., Solomon, D. H., 

Leape, 1.. 1.. , Kahan, J. P .• Park, R. E., and Brook, R. H., Abdominal Aortic Aneurysm Surl:"[)' A 

literature review and raljolls ofapll[ol2riateness aDd necessit),. Publ JRA04. Santa Monica, t 992, the 

RAND Corporation. 

18. Bernstein. S. J., Laouri, M., Hilborne, 1.. H., Leape, L. L., Kahan, J. P., Park, R. E., Kamberg, C. J., 

and Brook, R. H., Coronary AOiiofrapby A literature review and [atjoas o(approprjaleoess and 

n=si1y. Pub!. JRA03 Santa Monica, 1992, the RAND Corporation. 

19. Leape, L. L., Freshour, M. A., Yntema, D. B., and Hsiao, W., Small-group judgment methods for 

detennining resource-based relative values. Medical Care, 1992, 3O:NS28-39. 

20. Leape, L. L., The Future of Surgery. In: Blendon, R. J. and Hyams, T. S., eds. Refonnine Ibe system· 

Comainine costs in an era of universal access. Washington, DC, 1992, Faulkner and Gray. 

21. Bates, D. W., Leape, 1.. L. and Petrycki, S., Incidence and preventability of adverse drug events in 

hospitalized adults. J. General Internal Medicine 1993, 8:289-294. 

22. Weiler, P. c., Hiall, H. H., Newhouse, J. P., Brennan, T. A., Johnson, W. G., and Leape, L. L., 

Patients doctors and lawyers' A study of medical injury malpractice lilia-alioD and patient 

compensation. Cambridge, Harvard University Press. 1993 

23. Leape, L. 1.., Hilbome, 1.. H., Park, R. E., Bernstein, S. J., Kamberg, C. J., Sherwood, M., and Brook, 

R. H., The appropriateness of use of coronary artery bypass graft surgery in New York state. JAMA, 

1993,269:753-760. 

24. Hilborne,1.. H., Leape, 1.. L., Bernstein, S. J., Park, R. E., Fiske, M. E., Kamberg, C. J., Roth, C. P .. 

and Brook, R. H., The appropriateness of use of percutaneous transluminal coronary angioplasty in 

New York state. JAMA, 1993, 269:761-765 

25. Bernstein, S. J., Hilbome, 1.. H., Leape. L L, Fiske. M. E., Park, R. E., Kamberg. C. J., and Brook, 

R. H., The appropriateness of use of coronary angiography in New York state. JAMA, 1993, 269:766-

769 
105 

26. Leape, L. L., Practice Guidelines. In: Goldstone, J, et ai, eds., Perspectives in Yascular Sureery 6: 117-

127, 1993, St Louis, Quality Medical Publishing. 

27. Leape, L. L., Lawthers, A. G., Brennan, T. A .. and Johnson, W.G., The preventability of medical 

injury. Qual Rev Bull 1993, 19:144-149. 

28. Leape, L. L., McGlynn, E. A., Naylor, C. D., Bernstein, S. J .. The Canadian Coronary Angiography 

Panel, Park, R. E., Kahan, J. P., and Brook, R. H., Coronary Aneioeraphy' Ratines of 

Appropriateness and Necessity by a Canadian Panel Pub!. MR-129-CWF/PCT Santa Monica, 199:1, 

the RAND Corporation. 

29. Naylor, C. D., McGlynn, E. A., Leape, L. L., Hilborne, L. H., The Canadian Revascularization Panel, 

Park, R. E., Kahan, J. P., and Brook, R. H., Coronary Artery Bypass Graft Sureery and PercllHlneolls 

Translumioal Coronary Angioplasty' Ratings ofAppTopriateness and Necessity by a Canadian Panel 

Pub!. MR-128-CWFIPCT Santa Monica, 1993, the RAND Corporation. 

30. ShifTman, R.N., Leape, L. L., and Greenes, R. A., Translation of appropriateness criteria into practice 

guidelines: Application of decision table techniques to the RAND criteria for coronary artery bypass 

graft. Proc. 17th SCAMC (1993) 243-252. 

31. Leape, L. L., Strengthening the connection between evaluative research and coverage adoption 

decisions. In: Gelijns et ai, eds, AdOPtion decisions in Health Care. Washington. D.C., 1994, National 

Academy Press. 

32. Leape, L. L., The Preventability of Medical Injury. In: Bogner, M. S., ed., Human Error in Medicine, 

1994, Lawrence Erlbaum Associates. 

33. McGlynn, E. A., Naylor, C. D., Anderson, G. M .. Leape, L. L., Park, R. E., Hilbome, L. H., Bernstein, 

S. J., Goldman, B. S., Armstrong, P. W .. Keesey, J. W., McDonald, L., Pinfold, S. P., Damberg, c., 

Sherwood, M. J., Brook, R. H., Comparison of the appropriateness of coronary angiography and 

coronary artery bypass graft surgery between Canada and New York State. JAMA, 1994, 272:934-940. 

34. Kahan, J. P., Bernstein, S. J .. Leape, L. L., Hilborne, L. H., Park, R. E., Parker, L.. Kamberg, C.J., and 

Brook, R. H. Measuring the necessity of medical procedures. Medical Care, 1994,4:357-365. 

35. Leape, L. L., Error in Medicine. JAMA, 1994,272:1851-1857. 

36. Bernstein, S. J., Hilbome, L. H., Leape, L. L., Park, R. E., and Brook, R. H., The appropriateness of 

use of cardiovascular procedures in men and women. Arch Int Med, 1994, 154:2759-2765. 

37. Bates, D. W., Boyle, D., Vander Vliet, M .. Schneider, J., and Leape, L. L.. Relationship between 

medication errors and adverse drug events. J. Gen Int Med, 1995, 10:199-205. 

38. Leape, L. L., Preventing adverse drug events. Am J Health-Syst Pharm, 1995, 52:379-382. 

39. Leape, L. L., Translating medical science into medical practice. Do we need a National Medical 

Standards Board? JAMA, 1995,273:1534-1537. 
106 

40. Leape, L. L .. Bales, D. W .. Cullen, D. J., Cooper, J., Demonaco, H. J., Gallivan, T., Hallisey, R.,lves, 

J., Laird, N .. LafTel, G., Nemeskal, N., Pelersen, L. A., Porter, K., Servi. D .. Shea, B. F., Small, S., 

Sweilzer, B., Thompson, B. T., and Vander Vliel, M., Syslems analysis of adverse drug even Is. JAM A, 

1995,274:35-43. 

41. Bales, D. W., Cullen, D. J., Laird, N., Pelersen, L. A., Small, S., Servi, D., Laffel. G., Sweilzer, B., Shea, 

B. F., Hallisey, R., VanderVliel, M .. Nemeskal, R .. and Leape, L. L.. Incidenceofadversedrugevenls 

and polenlial adverse drug evenls: Implicalions for prevenlion. JAM A, 1995.274:29-34 

42. Cullen, D. J., Bales, D. W., Small, S. D .. Cooper, J. B., Nemeskal, A. R .. and Leape. L. L.. The 

incidenl reporling syslem does nOI delecl adverse drug even Is: A problem in quality assurance. JI Com 

J Quallmprov, 1995,21:541-548. 

43. Leape, L. L., A brief accounl of Ihe founding of Ihe American Pedialric Surgical Associalion. J. Ped 

Surg, 1996,31:12-18. 

44. Kahan, J. p .. Park, R. E., Leape, L. L., Bernslein, S. J., Hilborne, L. H., Parker, L.. Kamberg, CJ .. 

Ballard, D. J., and Brook. R. H. Varialions by specialty in physician ralings oflhe approprialeness and 

necessily of indica lions for procedures. Med Care. 1996,34:512-523 

45. Leape, L. L., Hilborne L. H .. Schwartz, J. S., Bales, D.W., Rubin. H. R .. MD. PhD; Slavin, P. L., Park, 

R. E., Willer, D. M .. Panzer, R. J., Brook. R. H., and Ihe Working Group of Ihe Approprialeness 

Projecl oflhe AMCC, The approprialenessofcoronary arlery bypass graft surgery in academic medical 

cenlers. Ann Inl Med, 1996, 125:8-18. 

46. Leape, L. L., An overview of adverse drug events. U.S. Pharm, 1996. October Surrlement: 2-8. 

47. Leape, L.L.. OUI oflhe darkness. Hllh Sys Rev. 1996. NovlDec:21-24 

48. Bates, D.W .. Miller, E., Bernstein, SJ., Haurlman, PJ .. and Leape, L. L., Coronary angiography after 

acule myocardial infarction: A literature review. Ann Int Med, 1997, 126:351-359. 

press. 

49. Bates, D.W .. Spell, N., Cullen, DJ., Burdick. E., Laired, N .. Petersen, L.A .. Small. S.D., Sweilzer. BJ .. 

and Leape, L.L., Thecosls of adverse drug even Is in hospitalized patients. JAMA, 1997; 277:307-311. 

50. Matchar, D.B .. Oddone, E.Z., McCrory, D.C.. Goldstein. L.B., Landsman, P.B .. Samsa, G .. Brook. 

R.H., Kamberg, C .. Hilborne, L.H., Leape. L.L., and Horner, R.,lnOuenceofprojectedcomplication 

rales on eSlimated appropriale use rates for carotid endartereclomy. Hllh Serv Res. In press. 

51. Leape, L.L., A systems analysis approach to medical error. In: M.R. Cohen and N.M. Davis, 

Medication Errors' Causes and Prevention, Washington, DC .. Am Phann Assoc. In Press. 
107 

STATEMENT OF 

KENNETH W. KIZER, M.D., M.P.H. 

UNDER SECRETARY FOR HEALTH 

DEPARTMENT OF VETERANS AFFAIRS 

ON VA'S RISK MANAGEMENT POLICIES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

OCTOBER 8,1997 

Mr. Chainnan, I am here to discuss VHA's risk management program and changes that 

have been made to facilitate system leaming to reduce untoward outcomes related to 

medical treatment. Before addressing specifics of our risk management policy, however, 

I want to briefly describe VHA's overall approach to quality management. 

VHA's Approach to Quality Maoa~ement 

As you know, during the last 2-3 years, great progress has been made in reengineering the 

veterans healthcare system. Many of the changes that have occurred were thought to be 

impossible not long ago. 

As part of this reengineering effort we have ,;nplemented a very ccmprehensive quality 

care framework. This framework consists of 12 dimensions. In brief, these dimensions 

are as follows: 

1. Credentialing and privileging of personnel. 

2. Accreditation of programs, facilities, and networks by such groups as the Joint 

Commission on Accreditation of Healthcare Organizations, the Commission on 

Accreditation of Rehabilitation Facilities, the American College of Surgeons, and 

the College of American Pathologists, to name a few. 
108 

3. 1m itution of clinical care strategies such as practice guidelines and clinical 

pathways, case management, provider profiling, shared decision-making, and 

improved palliative care. 

4. Use of performance indicators such as the new Chronic Disease and Prevention 

Indexes, surgical morbidity and mortality rates, and standardized functional 

outcome instruments. 

S. Internal review through mechanisms such as clinical pathology conferences and ad 

hoc review teams. 

6. External and independent review from contracted external peer review 

organizations and from such entities as the General Accounting Office, 

the Inspector General, and congressional oversight committees. 

7. Customer feedback from such activities as patient satisfaction surveys, patient 

focus groups, and patient complaint traclting. 

8. Continuous quality improvement activities such as the National Quality Council, 

360-degree personnel evaluations and employee satisfaction surveys. 

9. A risk management program that encourages open reporting of untoward outcomes 

and includes an adverse events registry and root cause analysis, among other 

specific methods. 

10. Use of VA's education apparatus for training healthcare professionals as well as 

the new VA Leaming University that focuses on workforce development. 

11. Research in areas such as quality of care, clinical care studies, health services 

delivery, and technol0gy assessment. 

12. Change management and organizational learning through activities such as 

executive performance agreements, a new resource allocation strategy (VERA), and 

integrated collaborative planning. 

It is important to understand the various dimensions of the framework, and what they 

target, when considering the specific function of the risk management policy and role of 

the Office of the Medical Inspector (OMI). 
109 

Risk Mana~ement in YHA 

I would like to tum now to our risk management program, the major focus of today' s 

hearing. This is a program that focuses primarily on patient safety -- i.e., on adverse 

events that are related directly or indirectly to medical treatment. 

A number of well publicized and tragic events during the last few years have made it 

clear that increasing patient safety should be a national priority for healthcare systems 

everywhere. Research findings certainly support this conclusion. In particular, the 

widely respected Harvard Medical Practice Study indicated that 180,000 Americans die 

each year and 1.1 million are injured or disabled because of adverse events, two-thirds of 

which are thought to be preventable. Other studies have found that about 5 per 1,000 inpatients experience an adverse event that results in their deatlt. Investigators also report 

that they believe these data represent the lower limits ofthe occurrence of these events 

and that the actual occurrence is much higher. 

VHA has recently implemented an improved risk management program that I believe will 

place it at the forefront of efforts everywhere to provide safer medical care. Indeed, on 

sharing drafts oftbis policy with various private sector organizations they have all been 

highly complimentary. 

VHA's program is based on a new paradigm for risk management - one which has 

emerged from a number of significant research findings during the last few years. First, 

studies of private sector care, such as the Harvard Medical Practice Study, have shown 

that serious injuries resulting from medical care are common - in fact, much more 

common than generally believed. Second, most of these patient injuries result from 

preventable errors. Third, errors usually result from poorly designed systems or 

processes that either induce errors or make them difficult to detect and intercept (as 

opposed to negligent or ill intentioned people). Fourth, and most important, analysis of 

the underlying systems can often lead to process or system redesigns that will 
110 

significantly reduce the likelihood of errors. The latter requires an atmosphere that 

encourages complete reporting and thoughtful analysis of such problems. 

Based on these compelling findings, VHA is focused on designing patient care systems 

that will prevent errors. Implicit in this design is the need to break down currently 

prevalent disincentives for addressing medical errors. These disincentives include the 

traditional medical care culture that finds it difficult to acknowledge errors and mistakes, 

as well as the fear of litigation and sensationalistic anecdotal media coverage. In its 

place, we need to create a culture that permits medical care personnel to acknowledge the 

occurrence of errors and encourages open and complete reporting of adverse events. Of 

course, the system also has to ensure that when appropriate, personnel actions should be 

taken against employees whose negligence led to a patient injury. However, we are 

convinced that the real payoff in improving patient safety will come from changing the 

way medical care is provided in the V A and in the healthcare system overall. 

We are using several different strategies to identifY and make needed changes. First, our 

facilities routinely analyze all service delivery systems to identifY redesigns of those 

systems that will increase patient safety. These analyses involve: (l) identifYing those 

medical care processes most in need of redesign, and (2) introducing checks and balances 

for each of these processes so that the likelihood of errors is zero. The well-established 

procedure of having two staff independently check a patient's identity before 

administering a transfusio.' is a simple example of checks and balances. Another is the 

lise of bar coding to prevent medication errors by electronically verifYing the patient, 

drug, route, and time against the original order before a drug is given to a patient. 

A second procedure to increase safety is to intensively review all adverse events from a 

care-site specific and systemwide focus. These reviews identifY the root causes of each 

incident, the changes in design of systems needed to prevent recurrence, and any 

appropriate personnel actions. 
111 

Under VHA's new protocol, all reviews of adverse events are sent to the network office 

and to VHA headquarters where they are reviewed to identify: 

1. The adequacy of the facility review and the appropriateness of the actions taken, 

2. The frequency with which particular care delivery systems have been problematic 

so managers know where the best opportunities for improvement exist, 

3. System redesigns that should be adopted throughout the network or nationally, 

4. Needed changes in network and national policies and procedures, and 

5. Lessons learned that can be shared throughout VHA on an Intranet database. 

Within Headquarters, a Risk Management Oversight Committee accomplishes this 

review with representatives from the Offices ofthe Chief Network Officer, Performance 

and Quality, Medical Inspector, and Patient Care Services. As needed, the committee 

obtains the input of subject matter experts from throughout VHA. At a recent meeting, 

the committee reviewed a case involving the pharmacy mail out program and requested 

that VHA's ChiefInformation Officer and Chief Pharmacy Consultant also review this 

adverse event. As a result of their review, the committee decided that this incident 

contained important lessons. VHA software designers are now modifying the software 

for entering prescriptions to prevent such errors systemwide. 

The sharing of risk management information between our facilities, particularly 

innovative system redesigns, is another key aspect of our improved program. All current 

VHA communication media, such as weekly VISN director conference calls and 

regularly scheduled nation-wide risk management conference calls, are being used for 

this purpose. In addition, a Lessons Learned Database on VA's Intranet is being 

developed as an interactive medium for the sharing of risk management information 

throughout our system. Information will be routinely entered by facility staff as well as 

the Risk Management Oversight Committee and the Offices of the Medical Inspector and 

Performance and Quality. 
112 

The improved policy also requires medical faclljties to review morbidity and mortality 

data generated by national monitoring programs to identify problems in quality of care. 

The new policy also provides specific guidance regarding the notification of law 

enforcement authorities and other appropriate actions when review of morbidity and 

mortality data indicate an association between a specific practitioner and increased 

morbidity or mortality rates. 

Finally, VHA's new Risk Management policy continues VHA's emphasis on minimizing 

the negative consequences of injuries to patients. It requires facility staff to promptly 

infonn patients and their families about the clinical facts associated with injuries reSUlting 

from medical care, assuring them that measures have been taken to maintain life and 

minimize disability and discomfort. In addition, facility staff are required to advise 

patients and their families of any remedial options including clinical care and possible 

compensation. 

To encourage rapid and effective implementation of its improved risk management 

program, VHA will include a risk management measure in its network director 

performance measures for FY 1998. To be fully successful in achieving this measure, a 

network must redesign a number of major service delivery systems to improve patient 

safety at all applicable network facilities. Site visits to validate the supporting 

documentation provided by the network will be performed. An exceptional rating 

requires also having at least one system redesign from the network assessed by other 

networks as one of the 10 system redesigns presented on the Lessons Learned Intranet 

Database that were most useful to them in redesigning their own care delivery systems. 

Role of Medical Inspector 

Mr. Chairman, you also requested that I discuss the role, function and organizational 

structure of the Office of the Medical Inspector (OMI) as it relates to Risk Management, 

and its other responsibilities. 
113 

The Office of the Medical Inspector is organizationally an adjunct of the Office of the 

Under Secretary for Health, and the Modicallnspector reports directly to me. The office 

is directed by a highly qualified physician with a unique background of many years 

assessing quality of care for the Joint Commission on Accreditation of Health care 

Organizations. His staff includes an experienced nurse with a Ph.D. in Epidemiology, an 

experienced health systems specialist with a Masters in Public Health and a Doctor of 

Science in Operations Research, two master level Health Systems Specialists, one with 

extensive knowledge and experience in planning and fiscal matters and the other with 

extensive clinical and quality assurance knowledge as an allied health professional and 

three office assistants. One of the health systems specialists is detailed to another agency 

for one year. Some time ago, I recognized the need for more personnel and authorized 

the OMI to hire two additional staff, a nurse and a physician. A nurse who served as a 

chief nurse at one of our facilities recently joined the OMI staff. She brings to the staff 

additional field perspective. A physician is being recruited. 

The Medical Inspector is authorized to use specialists and consultants from the field, as 

needed, to carry out site visits and to conduct reviews. Depending on the issues, a 

specific interdisciplinary tearn is assemblod for each site visit. OMI staff advise and 

direct the tearn and coordinate the site visit. Over 75 physicians, nurses, social workers, 

patient representatives, quality improvement managers, and others have participated in 

the past year. On occasion, the OMI joins forces with staff from the Office of Healthcare 

Inspections (OHI), Office of the Inspector General, on investigations when expertise from 

both offices is needed. The OHI also oversees the work of the OMI. 

Th" OMI conducts case-specific/incJdent-specific and some program quality of care 

reviews through investigations, site visits, and other analyses. These are performed at the 

request of the Secretary of Veterans Affairs, the Under Secretary for Health, individual 

veterans, and a number of other stakeholders. These reviews range from the care 

provided tu an individual patient to the quality of care provided by a medical center or 
114 

Veterans Integrated Service Network (VISN). A formal report of each investigation and 

review is developed and sent in draft form for comments to me and to other appropriate 

program offices, including the Office of the Inspector General. The final report contains 

findings, conclusions and, if applicable, recommendations. The involved medical center, 

VISN, or program office submits an action plan that addresses the recommendations. 

The action plan is monitored over time. When actions are completed, and supported by 

documentation, the report is closed. In the preceding 12-month period, the OMI 

conducted 21 reviews and investigations, 

I have directed that VHA staff give all information requested and their full cooperation to 

the OMI in its reviews and investigations. By the same token. I have insisted that the 

OMI conduct objective and independent reviews and investigations, and that they submit 

thorough and fair reports. 

Within the context of the new Risk Management Directive, the OMI assumes both 

reactive and proactive roles. The OMI has timely access to reports of adverse events, 

such as unexpected deaths and serious injuries to veterans. as well as to the reports of all 

Boards of Investigation and focused reviews. The new Risk Management policy provides 

for this access by requiring facilities and networks to report particularly significant 

adverse events to the Chief Network Officer within 48 hours who, in tum, provides the 

information to the office of the OMI and others. The circumstances surrounding these 

events are evaluated and actions are taken at the local facility and network levels. In the 

majority of instances, no further action is required at VHA Headquarters. I rely on the 

OMI and others to assess this information on a regular basis and to take appropriate 

action. The OMI is also involved in the development ofa registry of adverse events that 

will serve as a resource for all relevant offices in YHA Headquarters and field facilities 

and the OMI will be a regular contributor to our 'Lessons Learned' hornepage. 
115 

In addition to focllsed reviews and involvement with other risk management functions, I 

have asked the OMI to conduct other reviews or studies. This can best be illustrated by 

two recent examples. In January 1997, to become better informed as to whether Gulf 

War veterans were listened to about their possible exposure to various chemical and 

environmental agents, I asked the OMI to conduct a review of medical records to see 

what was documented regarding potential exposure to environmental agents. In the space 

of three weeks, the staff visited nine hospitals and reviewed a sample of 1200 medical 

records and reported their findings to me. In brief, the OMI concluded that VA Registry 

staffs at the selected VA facilities had been listening to Persian Gulf War veterans about 

possible exposure to environmental contaminants, particularly in the last two years. The 

second example was an analysis by OMI staff of all Boards of Investigation of Patient 

Abuse cases in inpatient settings over a period of three years, 1992 through 1994. The 

analysis showed an upward trend in the nwnber of both alleged :md substantiated patient 

abuse incidents in our V A facilities for the period. It was on this basis that my office 

authorized the formation and funding of a highly specialized task force to study the issue 

in depth and to render a report with recommendations for corrective actions to be taken. 

In reviewing the role and functions of the OMI, I recognized the need for an outside 

review. As with other offices in VHA Headquarters, such evaluations are helpful in 

informing decision-making as it relates to the size and mix of the staff, and to changes in 

functions and organizational placement. This review is in progress and should be 

completed within 2-3 months. 

To summarize, the OMI has a distinct and important place in VHA Headquarters. Its role 

in Risk Management events, its evaluation of quality of care issues, its ability to 

recommend changes and corrective actions, and its monitoring of the implementation of 

r,e changes and actions, serves to enhance the quality of V A healtheare. 
116 

Overall, Mr. Chainnan, while I believe VA's record on patient safety is a good one 

compared to other healthcare systems, there is room for improvement. I believe V Ns 

present framework for assuring quality of care, which includes the new risk management 

policy and a clarified role for the OMI, will translate into more rapid and more complete 

system learning about improving patient safety and far fewer adverse events related to 

medical care. 

This concludes my statement. I will be pleased to respond to your questions. 
117 

STATEMENT OF DR. JOHN H. MATHER 

ASSISTANT INSPECTOR GENERAL 

DEPARTMENT OF VETERANS AFFAIRS 

BEFORE THE SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON VETERANS' AFFAIRS, 

UNITED STATES HOUSE OF REPRESENTATIVES 

OVERSIGHT HEARING ON 

THE VETERANS HEALTH ADMINISTRATION'S 

RISK MANAGEMENT PROGRAM AND 

ITS OFFICE OF MEDICAL INSPECTOR 

OCTOBER 8, 1997 

Mr. Chairman and Members of the Subcommittee, I appreciate the opportunity to 

appear today to discuss the Veterans Health Administration's policy and 

performance in the area of risk management, and the mission, role, and 

organizational structure of its Office of Medical Inspector (OMI), as it relates to 

both risk management and the OMl's other responsibilities. 

,. Office of Inspector General (OIG) Role 

The Office of Inspector General (OIG) has a mandate to provide independent 

oversight of the Department of Veterans Affairs. The OIG is accountable to both 

Congress and the Department in carrying out its mission to promote economy, 

efficiency, and effectiveness in VA operations; to detect and prevent fraud, waste, 

and abuse in VA programs; and to monitor V A' s medical quality-assurance 

programs. In carrying out its mission, one of the OIG's primary goals is to help 

management succeed in its effort to reinvent government; that is, to build a 

government that works better and costs less for the benefit of today's and 

tomorrow's veterans and taxpayers. This goal speaks to the very essence of the 

OIG mission--and unites us with Department management and Congress as we 

strive together to ensure that quality services are delivered to veterans in a cost 

effective, efficient, and timely manner. 

2. OIG Monitoring of Quality AllUrance 

In the mid-1 980s, a perception developed that, at least in the area of having 

proficiency in the formal implementation of the healthcare quality assurance (QA) 

process, VA was lagging. The General Accounting Office (GAO) reported, ·VA Has 

Not Fully Implemented Its Health Care Quality Assurance Systems " • in June 

1985, followed immediately by a U.S. House of Representatives report entitled 

"Patients At Risk: A Study Of Deficiencies In the Veterans Administration Medical 

Quality Assurance Program,,2 Both reports were very critical of VA's formal QA 

programs and processes. 

The GAO similarly criticized the VA Central Office's Office of the Medical Inspector 

(OMI) established to oversee quasi-legal and quasi-medical aspects of VA, mainly 

VA's patient injury control program, patient abuse, and practitioner licensing 

sanctions. VA's Medical Inspector office, which had been established within the 

I VA Has Not Fully Implemented Its Health Care Quality Assurance Systems, U.S. General Accounting Office, 

GAOIHRD-85-57, June 27, 1985 

2 Patients At Risk: A Study of Deficiencies in the Veterans Administration Medical Quality Assurance Program, 

Seventh /Report By the Committee on Government Operations Together With Separate Views. April 30, 1987, U.S. 

Government Printing Office, Washington: 1987 
118 

Veterans Health Administration (VHA) in response to an apparent lack of effective 

central oversight and medical investigator capacity, was felt to require substantial 

revision in the GAO report, "VA's Patient Injury Control Program Not Effective. "3 

It is consistent with the broad charter of VA's IG--mainly the obligation to monitor 

the economy, efficiency, and effectiveness of the Department's programs and 

activities--to oversee V A healthcare and QA activities. Nonetheless, after 

substantial debate, Congress decided to provide emphasis in this area for VA's IG. 

The first specific attempt at such a focus through the OIG was in Public Law 99-

166, "The Veterans' Administration Health-Care Amendments of 1985,"4 which 

mandated that "The Inspector General of the Veterans' Administration shall allocate 

sufficient resources including sufficient personnel with the necessary skills and 

qualifications to enable the Inspector General to monitor the [healthcarel quality 

assurance program." Eventually the Congress was to extend this legislation and, in 

the "Veterans Benefits and Services Act of 1988"5, Public Law 1 00-322. It was 

more fully elaborated that VA should "upgrade and expand the activities of the 

Veterans' Administration's Office of Inspector General in overseeing, monitoring, 

and evaluating the operations of the Department of Medicine and Surgery's [VHA'sl 

quality-assurance programs and activities and its Medical Inspector office so as to 

provide the Chief Medical Director [Under Secretary for Health], the Administrator 

[Secretary]' and the Congress with clear and objective assessments of the 

effectiveness of those programs and operations, including ensuring such numbers 

of, and such skills and training on the part of, employees assigned to the Office of 

Inspector General as are necessary to carry out such oversight, monitoring, and 

evaluation effectively. " 

3. PIG Organizational Focus' Office of Healthears Inspections 

In 1988, VA's IG established a support Division within its Policy, Planning, and 

Resources Office known as the Quality Assurance Review Division (QARD). This 

Division was staffed in 1989. In 1991, coincident with the continuing and, indeed, 

increasing prominence of QA and oversight of health care systems, the QARD was 

upgraded to a full VA OIG "office," co-equal organizationally with its Office of 

Audit and Office of Investigations. This Office is named the Office of Healthcare 

Inspections (OHI). 

The OHI fulfills for the 10 the primary focus for general oversight and monitoring of 

VHA's quality-assurance activities and programs, and oversight of the VHA's OMI. 

These broad responsibilities are ongoing and become most specific as regards 

program evaluations, Hotline inspections, and the development of a new Quality 

Program Assistance (QPA) review. 

a. General Oversight 

i. Oversight of VA's QA Programs 

Oversight of VA's QA programs at all levels, particularly its VACOIVHA Quality 

Assurance Office (now named, Office of Performance and Quality) was specifically 

mandated by Congress. OHI attempts to meet this mandate in two general ways. 

In individual case reviews, a facility's QA programs are routinely assessed, and 

J V A Health Care, VA's Patient Injury Control Program Not Effective, U.s. General Accounting Office, 

GAO/HRD·87-49, May, 1987 

4 Public Law 99-166, "The Veterans' Administration Health-Care Amendments of 15," 99 STAT. 941, Title II--

Health Care Administration Sec. 201 - 204, December 3, 1985 

5 "Veterans' Benefits and Services Act of 1978," May 20, 1988, Public Law 100-322, Section 201, 102 Stat. 508-

509 

2 
119 

generally commented upon in conjunction with OHI hotline inspections. Second, 

OHI understands that VACONHA coordinates several nationwide OA programs. 

These include its "Occurrence Screening Program," "The Patient Incident Reporting 

System,' "Tort Claims Analysis," "Patient Satisfaction Survey Program, " 

"Utilization Management Program: "Cardiac Surgery Review Program,' and the 

"External Peer Review Program." 

OHI, in its oversight capacity has reviewed the strengths and weaknesses of many 

of these programs, such as the "Evaluation of the Veterans Health Administration's 

Patient Satisfaction Survey Program.' This was followed by an "Evaluation of the 

Veterans Health Administration's Ouality Improvement Checklist (OUIC) Program,' 

and "Evaluation Of The Patient Representative Program." Its most recent report of 

a V ACONHA directed OA program is a review of the "External Peer Review 

Program." 

Earlier this year, OHI initiated an evaluation of VHA's quality assurance program at 

the request of the Senate Veterans' Affairs Committee (SVAC). This review will 

encompass and conduct: 

1. A comprehensive evaluation of the VHA's current OA activities, including those 

at the V ACO level the VISN level, and the local V A medical center (V AM C) level. 

2. Identifying specific guidance provided to field facilities about OA matters, 

3. Identifying the number of personnel who are assigned OA responsibilities on a 

full or part-time basis, and determine if they have the resources, authority, and 

access to ensure veterans receive quality care. 

OHI is in the midst of this review which will include a review of VHA's risk 

management program. It is anticipated that this will be completed early in 1998. 

ii. Ollllfsight of the Office of Medica! Inspector 

VHA's Office of Medical Inspector (OM I) was established in 1980·. This office 

serves as an internal medicolegal oversight office for VHA, and in some sense 

might be considered a precursor to OHI. However, it is distinguished from the 

OIG's OHI, in that OMI is internal to VHA. OHI, being an OIG component, is 

external to the VHA. This distinction, which, unfortunately, has been a repeated 

cause of confusion, even to those familiar with VA, might be further explained by 

the analogy that the OMI serves as an internal overseer and "troubleshooter" for 

VHA and reports to the Under Secretary for Health (USH): while OHI is an external 

overseer of health care activities, reporting, through the Inspector General, to the 

Department's Secretary and Congress. These different reporting relationships 

provide the OHI with the assurance of an independence of its investigations that 

the OMI cannot always have. VHA's current operating philosophy is that the USH 

should have the opportunity to have available internal oversight mechanisms as a 

"troubleshooter" including an office configured as OMI, for a health care system the 

size of VHA. 

The above notwithstanding, Public law 100-322 provides OIG with a specific 

directive to oversee the OMI. This task has been approached in several ways. 

Initially, case reviews conducted by OMI are reviewed by OHI prior to final closure. 

In so reviewing the OMl's work, and having the imprimatur of final closure, both 

the quality and rigor of that Office's case reviews could be assessed, and hence the 

OMI overseen. likewise, this means of oversight provided OHI with a sense of the 

issues and controversies current within VHA. Second, as OHI evolved, the 

6 "Oversight Activities of the VA's Inspector General," Hearing Before the Committee on Petuans' Affairs. 

United Stales Senate, Ninety-Sixth Congress, Second Session, June II, 1980 
120 

approach of publishing a detailed summary report on the activities, needs, 

strengths, and weaknesses of OMI was added to OHl's oversight efforts of OM I, 

and this is discussed later. 

b. Specific Oversight 

L program Eyaluations 

More under the auspices of the IG Act than under Public Law 100-322 which 

focuses specifically on VA's quality assurance programs, review of VHA clinical 

programs other than strictly its OA programs, has been a continuing OHI activity. 

At the forefront of such program reviews are current critical issues in veterans 

health care. These include the Department's response to veterans who become ill 

after service in the Persian Gulf7

, provision of health care to an ever increasing 

number of female veterans· in a health care system largely designed to serve male 

veterans, and a review of VA's handling of the new, but extremely expensive and, 

toxic, high surveillance anti-schizophrenic drug clozapine'. In addition to the topics 

receiving medical and public attention, there are ongoing issues in veterans health 

care for which VA has developed programs, and which OHI inspected. These 

include VA's pro~rams addressing such issues as homeless ness, domiciliary care'o, 

ambulatory care' , Advance Directives 12 and the impact of downsizing substance 

abuse rehabilitation programs '3. It is anticipated that such programmatic reviews 

will continue, these being perennial health care issues which require oversight, and 

which are integral to a large health care system. 

ii. Hotljne Inspections 

To fulfill the OIG organizational charge of identifying waste, fraud, and abuse in the 

agency, VA's OIG, like most Federal OIGs, maintains a "hotline." This "hotline" is 

an "800 number," and an address which is prominently displayed in VA facilities 

(medical and non-medical), and listed in local telephone directories and more 

recently can be accessed on the OIG Internet. On the order of 20,000 hotline 

contacts yearly are made to VA's OIG. A large portion of these contacts are 

clinical or OA related and hence OHI has found itself involved in numerous hotline 

cases. Additionally, Congressional constituent referrals, White House case 

referrals, and cases prominently highlighted in the media are often assigned hotline 

status. While the majority of these cases must be referred to VHA for primary 

review, many are referred to OMI--thus reinforcing the need for OHI oversight of 

VHA. However, as a means of independent verification of VHA's work, and due to 

its status as a clinical oversight body independent of VHA, OHI also independently 

inspects approximately 100 hotline cases yearly. Most of OHl's hotline cases have 

very high profiles. Through OHI's performance of hotline reviews, oversight data is 

7 "An Oversight Evaluation Of The Department of Veterans Affairs' Response To Health Care Issues Relating To 

Military Service In the Persian Gulf War," VA OIG Report No.: 5HI-A28-01 t. December 29, 1994 

I "Evaluation of Papanicolaou Test Procedures for Veterans Health Administration Women Patients," VA DIG 

Report No.: 6HI·A2S-032, March 26, 1996 

9 "Review ofVHA's National Clozapine Coordinating Center," VA DIG Report.: 3HI-A28-153. August 27, 1993 

10 "Program Evaluation OCThe Veterans Health Administration's Domiciliary Care Program," VA OIG Report 

No.: 5HI-A2S·020, January 4, 1995 

II "Evaluation OF VHA's Ambulatory Care Program," VA OIG Report No.: SHI-A28-021, January 4, 1995 

12 "Evaluation of the Veterans Health Administration's Advance Directive Program," VA OIG Report No.: 7HIA2S-03 7. January 24, 1997 

n The Impact of Downsizing Inpatient Substance Abuse Rehabilitation Programs on Homeless Veterans and 

Other Frequen' USerlI," VA OIG Report No.: 7HI·A2S-10S, July S, 1997 

4 
121 

obtained in the form of independent verification of the quality and rigor of VHA' s 

review of such cases. These inspections often give some insight into the 

effectiveness of a VAMC's risk management program. OHI is currently conducting a 

review of all hotline cases for Fiscal Years 1993 through 1995 from which it is 

expected that some profiles and patterns will emerge. 

Also, OHI provides technical assistance to OIG's audit and criminal investigative 

branches. OHI provides technical assistance in clinical fields such as medicine, 

nursing, social work, respiratory therapy, nutrition, and clinical pharmacy to 

auditors and invastigators not trained in those areas. OHI technical assistance has 

led, on occasion, to identification of clinical, i.e., non-audit and non-criminal, quality 

assurance issuas, which may then ba reported under OHI cover. 

iii. Quality Program Assil1ance 'opA' Reyjew 

It has become apparent that OHI should "inspect" VHA's hospital facilities and 

inspect individual VAMC's OA programs, on-site, without the crisis atmosphere or 

adversarial nature that may accompany a hotline inspection. To meet this need, 

OHI is pioneering a system of proactive review. 

OHI hopes to develop and implement a program of comprehensive medical center 

reviews which includes an assessment of the medical care and provides VHA 

managers with independent, objective findings which will assist them in improving 

the efficiency and effectiveness of their operations. The principles guiding the OPA 

program development are: healthcare remains, at its core, the interaction of 

professionals (providers) with clients (patients); the program should focus on broad 

general indicators of healthcare quality; inspections should be direct and consider 

historic data only secondarily; the process should not be duplicative of other 

internal or external review programs; the inspections should be undertaken by 

generalist healthcare inspectors; the process should use standard instruments, 

which might eventually allow results to be compared from center-to-center; and the 

process should be cost effective. 

The program of OPA reviews was begun in early 1995 and after an initial pilot, six 

facilities were visited to further refine the process through late 1 996. After a 

careful review of the experience gained from those early endeavors, a final 

prototype was devised with the advice of some VISN clinical managers, and was 

tested at six VAMCs at the end of fiscal year 1997. If, after a final thorough 

evaluation, it is concluded that this is a "value added" process, then it is projected 

that the OPA reviews will become fully operational in 1998. 

4. OHI/OIG Oversight of YHA's Risk Management Policy 

The general purpose of a risk management policy in healthcare facilities and 

healthcare systems is to have program and operational requirements, which have a 

fundamental orientation towards prevention of errors in the provision of personal 

medical services. Hence it is expected that an effective risk management program 

will: 

• Minimize the likelihood of adverse events (risk) to patients, personnel and 

visitors; 

• Protect resources and prevent loss by accurately identifying, reporting, trending, 

reviewing, and correcting problems leading to incidents, through risk 

identification and analysis, and systems improvements; 

• Encourage healthcare facilities to view risk management as an overall activity 

which includes both clinical and administrative services; and 
122 

• Ensure that healthcare facilities, within a healthcare system, share information 

on adverse events which contributes to the systematic identification and 

assessment of their potentially harmful impacts. 

Both the VHA and the Joint Commission on Accreditation of Healthcare 

Organizations (JCAHO) identify risk management as an integral part of quality 

improvement activities. VHA has been active in risk management for many years. 

Two of VHA's many risk management programs are the Occurrence Screening 

Program (OS) and Patient Incident Reporting (PIR) Program. 

In May 1987, the GAO recommended that VAMCs be required to implement 

occurrence screening (see footnote 3). This interest resulted in legislation enacted 

in May 1988, Public Law 100-322, Section 201. Along with expanding and 

assigning higher priority and greater resources to quality-assurance programs and 

activities at each medical center, this law required the implementation of the review 

known as "occurrence screening" throughout all VAMCs. Patients' medical records 

are reviewed, with the maximum use of the facility's computerized management 

information system, for adverse events, which may not be the natural or expected 

consequence of the patient's disease, injury, or treatment. 

The OS Program was based on a 1977 California Medical Insurance Feasibility 

Study, which reported that almost 5 percent of hospital admissions were 

associated with an adverse event that was potentially compensable. In the OS 

Program, cases are screened against a predetermined list of criteria. Those cases, 

which involve one or more of the occurrences, are reviewed to identify possible 

problems in patient care. The PIR Program has long existed in all VA medical 

centers and in 1974 it became one of the initial programs included under the QA 

umbrella. The goal of the PIR Program is to identify opportunities for improvement 

in patient care by monitoring, reporting, analyzing, reviewing, and investigating (if 

necessary) any unusual, unexpected or unfavorable incident involving a patient 

during the course of the patient's medical management. 

Section 204(a) of Public Law 99-166, passed in 1985, and codified in Title 38 

United States Code (U.S.C.) 7311, required VA to establish a comprehensive 

Quality Assurance Program, of which PIR was a part. In early 1980, VA 

transferred the pr09ram to the Office of Medical Inspector. Then in 1991, the 

program was transferred to the Office of the Associate Chief Medical Director for 

Quality Management, now the Office of Performance and Quality. 

Both the OS and PIR Programs are automated and operate in the VA's 

Decentralized Hospital Computer Programs (DHCP). This allows V A to identify 

opportunities for improvements through local data analysis and the potential 

national roll-up of information relevant to the VHA healthcare system as a whole. 

The VHA guidance on its Risk Management program has, during the last 5 years, 

changed four times, with the issuance most recently of the Risk Management 

Directive VHA Directive 105, September 25, 1997, and its accompanying 

Handbook. Prior to the issuance of this Directive, the most specific general 

guidance had been contained in VA Manual M-2, Part I, Chapter 35, "Integrated 

Risk Management Program" (lRMP), issued April 7,1995. This was replaced with 

the VHA Directive 97-029, "Risk Management," June 6, 1997. The IRMP, April 7, 

1995, had replaced the previous Chapter 35, August 7, '992, with rescission of 

several other Directives. VHA guidance in each of these policy revisions has varied 

considerably in the scope, specificity and assignment of responsibilities at each 

managerial level in VHA: the VAMC, VISN and VACO. 

5. VHA's Risk Management Directives 

The present Risk Management Directive, VHA Directive 105, September 25, 1997, 

and its accompanying Handbook (hereafter referred to as the RM Directive) contains 

6 
123 

guidance which satisfactorily addresses several issues that have been of great 

concern to the OIG. Further this RM Directive encompasses features that make it a 

much more definitive and comprehensive document than has been heretofore 

available in VHA. If fully and consistently implemented it has the potential for 

becoming an effective risk management policy 

The issues, until the publication of this RM Directive, that have been outstanding 

for OHI/OIG are: 

a. Recommendations made in OHI program reviews agreed to by VHA, which had 

not been incorporated into the prior risk management guidance. 

b. Understandings reached with VHA concerning the tracking and trending of 

mortality data to identify unusual and unanticipated deaths. 

c. Ensuring that the guidance to VAMCs, VISNs, and VACO will result in 

continuing improvements in quality. 

The following discussion expands on these three areas: 

iJ. Incomoratjon of aHI/DIG recommendations 

Three OHI program reviews had made specific recommendations related to VHA's 

Risk Management Directive: 

i. "Oversight Inspection of the Veterans Health Administration's Office of Medical 

Inspector, Fiscal Year 1994" (Report No. 5HI-A28-039). - Recommendation lbDelete the paragraph in the M-2, Part I, Chapter 35 revision draft that delates OMl's 

review of VAMC's Boards of Investigation. 

This recommendation was implemented through the VHA Directive 97-029 "Risk 

Management," June 6, 1997. The role for the OMI has been further extended and 

clarified in the most recent RM Directive. 

ii. "Evaluation of VHA's Policies and Practices for Managing Violent or Potentially 

Violent Psychiatric Patients" (Report no. 6HI-A28-038). - Recommendation 1 a. The 

Under Secretary for Health should ensure that: 

la. All patient-on-patient and patient-on-staff assaults are proparly and uniformly 

entered into the automated PlR program at an V AMCs to ensure accurate counting 

of assaults, but more important, to ensure that all assaulters are identified and the 

circumstances of tha incidents are trended for use in both locel and national VHA 

planning and monitoring purposes. 

The issue of patients assaulting other patients or employees is a serious one. VHA 

health care facility right-sizing could exacerbate the problem and increase the risk of 

both types of assaults. When the subject report was issued in March 1996, the 

USH stated that one of the goals of a Risk Management Program would be to 

implement a uniform facility-level automated database that could also be accessed 

in VACO by the individual VISNs. The USH also stated that tracking, trending, and 

problem solution information could then be shared throughout the VHA. 

Implementation of such a system would necessitate a change in current regulations 

or PIR reporting as well as possible technical enhancements to the existing 

automated system. VHA Directive 97-029, Risk Management, dated June 6, 

1997, did not implement these commitments. The most recent RM Directive has 

now incorporated this important procedure. 
124 

iii. Alleged Cover-up of an Unexplained Increase in Deaths, Harry S. Truman VA 

Medical Center, Columbia, Missouri" (Report No. 5PR-A 19-115) -

Recommendation 4 - Revise M-2, Part I, Chapter 35 on reporting serious incidents 

at medical centers to provide clarifying guidance that facility Directors could use to 

determine if and when to report an incident such as the Columbia Medical Center's 

unexplained deaths to law enforcement authorities. The guidance in those cases 

where there is strong suspicion that a serious crime may have been committed, 

should emphasize both aggressive internal investigations to determine the possible 

clinical causes as well as simultaneous reporting to law enforcement officials. 

This recommendation was implemented through the VHA Directive 97-029, "Risk 

Management, .. June 6, 1997, as an improvement upon the previous Manual 

reference. Even so, OHI did not consider that the guidance was sufficiently specific 

or strong for a V AMC Director. The latest RM Directive has further clarified the 

procedures to be followed by VAMCs under these circumstances. 

b. Tracking and Trending of Mortality Data 

In Title 38 U.S.C. § 7311, "Quality Assurance", it is required that mechanisms for 

monitoring mortality and morbidity rates for surgical procedures be established. 

The National Surgical Quality Improvement Program (NSQIP) analyzes data on 

surgical mortality (within 30 days) and morbidity (presance of 1 or more 

postoperative morbidities within 30 days). NSQIP allows VHA to monitor surgical 

outcomes system-wide as well as locally. Data are shared with VAMC directors 

and surgeons to advise them of the quality of care they are providing and of 

opportunities for improvement. This system has the potential for monitoring 

significant fluctuations in mortality. 

In a broader context, stemming from situations at VAMC Columbia and other 

VAMCs in recent years related to unusual mortality occurrences, it has been 

considered essential that VHA develop more robust mechanisms of monitoring data 

on mortality. The expectation has been that a RM Directive would delineate 

tracking, trending, and analysis of specific risk management/quality indicators such 

as mortality and certain morbidity rates in order to achieve early identification of 

possibly serious, unacceptable health care practices. 

The rates for individual VAMCs, VISNs, and VACO in regard to the data or 

information to be monitored, collected, reported, analyzed, organized, and ·rolledup· would be specifically defined. Provisions would also be made for VHA's 

healthcare system to be alerted to unusual or unexpected mortality rates. 

The present RM Directive clearly provides an overall strategy to suitably track and 

trend information and data concerning unexpected deaths at the individual VA 

facility. The RM Directive's Appendix C clearly defines roles and responsibilities for 

the VAMC, VISN and VACO. In this same Appendix C, VISN directors are 

requested to designate from within the VISN a statistical consultant to assist in 

data analyses for risk management and other quality assurance functions. We 

consider these actions to fulfill VHA's commitment and should, when fully 

implemented, provide a vital mechanism for identifying unusual patient deaths from 

mortality data. 

c. EDlllriog CQD1inujog ImprpytHll8nt1 in Oua!!ty 

The present RM Directive has several features, which can potentially result in 

improvements to the quality of care for veterans across the VHA healthcare 

system. 

Mr. Chairman, recently you asked me to review VHA's response to the 

Committee's concerning 18 incidents in which there were patient deaths under 

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125 

allegedly unusual or apparently avoidable circumstances at VAMCs. There were 15 

incidents in which there was a confirmed specific misadventure, including deaths 

from burns, administration of incorrect medications or blood, and so forth. 

My personal impressions, as reported to you, were: 

• Almost without exception each VAMC seriously engaged with the issues related 

to the incidents. 

All VAMCs indicated immediate extensive investigation of the incidents, with 

possibly two exceptions. 

• The oversight by the RegionlVlSNs, OMI andlor OHI have ensured that these 

untoward incidents are definitively and completely reviewed, with few 

exceptions. 

Most of the 15 VAMCs with specific incidents have responded by careful indepth inquiries which have resulted in several local policy changes. 

• VAMCs which have reported incidents to external agencies, such as JCAHO and 

FDA, seem to be most highly motivated to complete more extensive facilitywide performance improvements such as root cause analyses. 

• VHA RegionslVlSNs and VACO did monitor these incidents, but it is unclear as 

to whether they have been accurately and consistently recorded on the DHCP 

data base. 

• The OMI and OHI, when inspections have been completed, have generally 

validated that the incidents were adequately managed, and in several instances 

confirmed an excellent response by the V AMC. 

The present RM Directive has the potential for ensuring greater accuracy and 

consistency in resolving these observations. Yet, there is an important question 

which goes beyond these 15 specific incidents, which is, "What has the corporate" 

VHA learned and what systematic changes in practices and policies have been 

promulgated throughout the VA's health care system, especially to all VAMCs, to 

assist them in preventing and avoiding similar occurrences? 

This RM Directive has specific roles for the VISNs and V ACO, including a 

mechanism for monitoring untoward events, with possible standardization of VISN 

risk management programs. Even so, the assistance role of the VISNs and VACO, 

capitalizing on the diligence at V AMCs to have effective Risk Management 

programs, will need to be evident and robust. The "lessons learned" from analyzing 

the specific incidents should be codified and disseminated in a timely fashion 

throughout VHA's health care system. 

6. Ovttl3igbt of YHA's Offic@ of tbl Medical InSDActo[ 

Almost 214 years ago, OHI filed a report on its oversight of the OMI14. The 

recommendations to the USH were: 

A. Either provide additional staffing to the Office of Medicallnspactor such that 

clinical staffing is incraasad sufficiently to perform its legislatively mandated 

function. This should resuit in an increase of at least four registered nursss and at 

least one senior physician; or 

14 "Oversight of the VHA's Office of Medical Inspector, Fiscal Year 1994," OIG Report No.: SHI-A28-039, 

February 16, 1995 

9 
126 

1. Submit a legislative proposal through the Office of the Secretary of 

Veterans Affairs to amend Public Law 100-322 to recognize the reduction in OMl's 

capability to conduct proper clinical evaluations; or 

2. Since the capability for independent oversight overall within VHA is 

seriously limited, initiate action to transfer the aMI's resources to OIG. 

B. Delete the paragraph in the M-2, Part I, Chapter 35 revision draft that deletes 

aMI's review of VAMCs' Boards of Investigation; and 

C. Authorize the OMI to continue development of the self-assessment instruments 

in order to assist VAMCs to strengthen known program weaknesses. 

Since then, only Recommendation B has been implemented through the recent RM 

Directive. 

In response to the report on the OMI, the USH concurred with Recommendation C, 

but indicated that he wanted to defer decisions on Recommendations A and B, until 

a new VACO organization has been completed. This was agreed to as an interim 

measure by the OIG. Now, Recommendation A remains unimplemented and 

Recommendation C has recently moved into a non-concur status. 

In May 1996, Dr. James McManus joined VHA as the new Director of OMI, i.e. the 

Medical Inspector, which brought the staffing level up to eight. Since then, the 

OMI lost its Deputy and one of its clinicians while adding a senior nurse located in 

Iowa City and, recently, another nurse in VACO. The OMI is currently recruiting 

for a physician Deputy. The staffing level will then be 9, which is far short of the 

OMI's initial more adequate 20 FTE staffing level. 

The OHI and OMI offices have always coordinated their hotline inspection activities. 

The OHI has generally assumed responsibility for inquiries originating in Congress 

and complex issues that mayor may not involve the OIG's Investigation office. 

The cooperation between all these offices continues. However, one of the impacts 

on OHI, from limited OMI staffing has been that OHI has hed to assume more of 

this workload, leaving OHI with constraints on its resources to perform its other 

healthcare oversight activities, described earlier. 

Just prior to Dr. McManus assuming the directorate of OMI, a VHA Directive 96-

021, March 20, 1996, "Cooperation with the Medical Inspector" was issued. The 

role of the OMI was stated to be: 

"The Medical Inspector serves as an investigative arm of the Office of the Under 

Secretary for Health (USH). When issues arise requiring further investigation, the 

USH, or designee, may ask the Madicallnspector to develop a factual analysis. In 

addition, the Medical Inspector may undertake investigation on bahalf of tha USH 

when requested to do so by veterans, VHA employees, the Inspector General, 

member of Congress or other stakeholders. " 

Late last year the USH responded to OIG follow-up inquiries as to the staffing and 

any modifications to the role of aMI. While the USH indicated additional FTE 

would be provided he also indicated that a contract would be awarded to an 

independent entity to study the structure and functioning of the OMI. This contract 

was awarded to Abt Associates, Inc., on May 6,1997, with a broedly dafined 

scope of work involving its assessment of the role, functions, and staffing of the 

OMI. The contractor's report is likely to be available in early November, according 

to VHA. 

10 
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Until this past month, we had understood the implementation of Recommendation 

C was only dependent on OMI having sufficient staff to develop self-assessment 

instruments. We were informed by VHA that it now will discontinue the 

development of self· assessment instruments. Rather, VHA will replace the original 

commitment through the activities of VHA's Office of Special Projects' "Lessons 

Learned" initiative. The "Lessons Learned" initiative is a reactive process that is 

instigated after a serious or catastrophic event has occurred. The self-assessment 

instruments are designed and intended to help prevent incidents from occurring in 

the first place. Presently, OIG is seeking from VHA a substantive explanation for 

its apparent change of direction, and an indication as to its vision regarding how its 

revised approach will be effectively assist in preventing serious adverse incidents in 

the future 

Hence, the OIG considers the issues raised in its report on the OMI to be mostly 

unresolved. 

7. An Analysis and present Status 

VHA, along with most of the healthcare professionals it employs, has long had 

policies that are directed towards ensuring veterans receive safe, effective personal 

healthcare in V AMCs with an assurance that their risk of incurring inadvertent 

actions that threaten disability and cause avoidable deaths is minimal. V AMCs have 

long had in place and have applied policies to use appropriate screening 

mechanisms, confidential reporting mechanisms and investigative processes to 

accurately monitor, identify, evaluate and correct harmful and potentially harmful 

health care circumstances. These procedures, when consistently and properly 

applied, help to prevent injury and avoid harm. 

VHA has a broad approach to quality assurance, including a risk management 

program, focused on achieving effective operations in the VAMCs, augmented by 

various oversight and investigative procedures. Over the past several years, it 

appears that when there are critical inadvertent and unusual adverse consequences 

to veterans in the course of receiving their healthcare through the V A, whether 

disability or death, VAMCs have for the most part taken the situations very 

seriously. In dealing with their own situations, VAMCs employees have conducted 

in-depth investigations, determined the nature of the error, assigned culpability, if 

needed, devised mechanisms to prevent similar incidents and filed reports with 

senior management. Unlike private sector healthcare providers, VAMC managers 

inform patients and families if they make serious errors, and explain their 

prerogatives for redress 

In providing VAMCs with policies and guidance for its Risk Management program, 

VHA has, over the past five years, provided a series of four Directives. The most 

recent RM Directive was published this past September 25th and constitutes a 

strong and comprehensive policy, which fully addresses criticisms the OIG/OHI had 

previously raised concerning omissions and weaknesses in prior RM Directives, 

particularly the one published this past June. The current RM Directive has the 

potential to strengthen and enhance VHA's present mechanisms for conducting an 

effective risk management program. 

In all previous RM guidance there have been V AMC reporting requirements and 

defined procedures for oversight by the Regions, (now replaced with 22 VISNs), 

and VACO. Within the past two years the VISNs have steadily been staffed, and 

the V ACO offices have gained new leadership. During this time period it is evident 

that issues related to resource allocation, strategic planning and the implementation 

of a performance measurement system have been dominant on VHA's agenda. As 

a consequence, little or no attention has been given to reviewing information on the 

Patient Incident Reporting (PIR) program either in the VISNs or in VACO. The 

recently published RM Directive seeks to remedy this deficiency by assigning more 

definitive roles to the VISNs and V ACO. It is essential that VISN programs be 

11 
128 

appropriately standardized to ensure that comparable data and information is 

collected and available for raview. The RM Directive has given some broed guidance 

in this regard although appointment of a statistician in each VISN can assist in 

ensuring some consistency in this regard. 

Once data and information on risk manegement is collected it is essential that it be 

tracked and routi . .,ely examined for trends. This requires assignment of clear roles 

and responsibilities in the VISNs and for VACO components. The RM Directive 

provides the clearest guidance so far in this area with the establishment of an 

Adverse Event Registry and the establishment in VACO of a Risk Management 

Oversight committee. The OMI is included on this committee but its participation is 

likely to be compromised as long as questions persist about its role, responsibilities 

and functions, and the staffing level in the office remains restrained. Without 

resolving these issues very soon, it is difficult to envisage how the OMI can 

significantly and effectively contribute to this activity. A regular and systematic 

review of the Adverse Event Registry, with the identification of relevant information 

that must be prompt in its dissemination to all VAMCs, is necessary. This 

communication is an essential feature of a Risk Management program for a 

healthcare system as large and complex as VHA. It provides the critical step in the 

sequence of an effective risk management program which, uses the broad 

dissemination of what has been learned from inadvertent event(sl, to assist in the 

prevention of a similar occurrence at the same or other VAMCs. 

8. ConG!w!lon 

The OHI is a QA oversight office, unlike any other in government, including the rest 

of the OIG community. It has direct clinical and OA oversight responsibilities under 

law. The task of monitoring a health system's effectiveness and overseeing its OA 

activities has proved to be most challenging in an era of shrinking government yet 

continuing increases in health care expenditures for veterans in VHA. 

In fulfilling its mandate to oversee VHA's quality assurance activities and the aMI, 

tha OHI/OIG has generally viewed VHA's need to address its risk management 

policies as paramount. VHA has made significant progress in this area with the 

possible notable exception of clarifying the OMI's role, function, and staffing. OIG 

will continue to monitor the implementation and effectiveness of VHA's recently 

published Risk Management Directive. 

12 
129 

• 

DEPARTMENT OF VETERANS AFFAIRS 

INSPECTOR GENERAL 

WASHINGTON DC 20420 

September 26, 1997 

The Honorable Cliff Stearns 

Chairman, Subcommittee on Health 

Committee on Veterans' Affairs, 

House of Representatives 

335 Cannon House Office Building 

Washington, DC, 20515 

Dear Congressman Stearns: 

I have now had an opportunity to more carefully review the report to you that I 

appended to my letter, September 17 th, 1997. 

I found some areas that were worthy of clarification and I have revisad the partl 

that discusses the JCAHO. Would you kindly replace the previous copy with this 

version? Thank you. 

Sincerely, 

H. MATHE , M.D. 

Assi ant 'nspec r General for 

Ithcare Ins etions 

En 

cc: Under Secretary for Health (101105E) 
130 

REPORT TO THE HOUSE VETERANS' AFFAIRS COMMITTEE 

"Patient Deaths under Unusual or Apparently Avoidable Circumstances at VAMCs" 

Introduction: 

The Subcommittee on Health House Veterans' Affairs Committee solicited in two 

seperate mailings in June and July, 1 997, information from 18 VA medical centers 

rela~d to the Committee's oversight of quality of care and risk ma?agement 

programs. The information requested concerned news reports of Mpatieht deaths 

under unusual or apparently avoidable circumstances at Department of Veterans 

Affairs Medical Centers W (VAMCs) Each letter focused on a specific incident or 

situation at the VAMC, seeking a full account of the circumstances which included 

information as to whether a Board of Investigation or other mode of inquiry was 

initiated. Also, specific questions on the involvement of the Veterans Health 

Administretion's (VHA) Office of the Medical Inspector (OMI) and/or the Office of 

Inspector General's (OIG) Office of Healthcare Inspections (OHI) were asked. 

Background: 

The general guidance for handling of unusual incidents for the time period for 1 2 of 

the 18 incidents is contained in M-2, Part I, Chapter 35, Mlntegrated Risk 

Management Program W (lRMP) that was issued April 7, 1995. This was replaced 

with the VHA Directive 97-029, MRisk Management," June 6, 1997. The IRMP, 

April 7, 1995, had replaced the previous Chapter 35, August 7, 1992, with 

rescission of several other Directives which reduced the VAMC reporting 

requirements. The earlier IRMP applies in 6 of the 18 incidents. 

The V AMCs requested to provide information and the approximate time frame of 

the incidents are: 

VA Medical Cente .. 11meFrame 

1. Atlanta, GA January 1997 

2. Baltimore, MD (Ft. Howard) March 1995 

3. B~Pinas, Fl AUllust 1994 

4. Backley, WV February 1994 

5. Boston, MA March 1996 

6. Huntington, WV December 1995 

7. Lake City, FL August 1996 

8. Miami, FL June 1996 

9. Muskogee, OK May 1996 

10. Northampton, MA IN/A) 1996 

11. Oklahoma City, OK January 1993 

12. Omaha, NE / JulV 1993 

13. Poplar Bluff, MO (St. Louis) August 1996 

14. Providence, RI March 1997 

15. Richmond, VA IN/A) 1996 

16. San Antonio, TX November 1996 

17. Temple, TX IN/A) March 1996 

18. West Los Angeles, CA February 1995 . . Note: N/A: Not Applicable to a speCifiC InCident . 
131 

2. 

Initial Analysis: 

Amongst these 1 8 incidents there are two situations in which patient deaths are 

not specifically identified with a confirmed specific misadventure (V AMCs 

Northampton and Richmond). While the OHI is and has been very closely involved 

with the issues involved, specific recommendations in the draft and final reports 

have been made and accepted by VHA for improvements. Another incident (VAMC 

Temple) involved deaths related to a contaminated oxygen supply that may have. 

been a contributing factor in four or six deaths. The OMI was involved in an 

exhaustive review of the situation. 

The other 1 5 incidents might be classified as follows, within the framework of 

inadvertent deaths: 

Type VAMCCs) - 15 

Scalding and/or Burns Atlanta, lake City, West los Angeles 

Drug Administration "Error" Baltimore, Omaha, Providence 

Misdiagnosed/Delayed/Fragmented Care Bay Pines, Beckley, Oklahoma City, Poplar 

Bluff 

Incorrect Blood Transfusion Boston, Huntington, San Antonio 

Exsanguination during Dialysis Miami 

Wandering and Accident Muskogee 

Establishment of Boards of Investigation: (See: IRMP Manual Chapter 35) 

The focus, in these 1 5 incidents, is related to deaths involving Mandatory 

Reportable Risk Events of Severity Level 3 and requires documentation on a VA 

Form 10-2633 with the information entered on the decentralized hospital computer 

program (DHCP) data base. Further, a Board of Investigation is convened in all 

cases where patient abuse is suspected and in certain other instances of reportable 

risk events. 

This review of the documentation provided by the VAMCs indicates that most of 

them completed VA Form 10-2633, and probably entered the information onto the 

DHCP data base. The accuracy and consistency of this requirement in the 18 

incidents could be independently validated through a separate query of the DHCP 

data base. 

Boards of Investigation were completed in 1 2 of the 1 5 instances. One was 

merged in an OIG/OHI inspection (VAMC Baltimore). One was conducted as a 

focus review with essentially the same level of effort as a Board of Investigation 

(VAMC Huntington). One was considered unnecessary (VAMC Oklahoma City) 

because the patient died at home, although the OHI did conduct and file an 

inspection report. 
132 

3. 

Reporting of Incidents: (See: IRMP Manual Chapter 35) 

In general, these types of incidents, because of their severity, would be reported to 

various other lellels in VHA. Until October 1995, with the abolishing of the four 

Regions and the establishment of the 22 Veterans Integrated Service Networks 

(VlsN), the VHA reporting requirements were very clear. The Regions were vitally 

and closely involved as they received an immediate notification and reviewed the 

results of the VAMCs management of the incident. Eventually a judgment would 

be rendered by the Region as to whether everything was done that was needed. 

VA Central Office (VACO) would often be less intimately involved, and sometimes 

after the Region had completed its oversight role. 

The documentation provided by the 15 VAMCs demonstrate that the Region or 

VlsN was notified, but the degree of oversight by them is variable. In certain 

instances the Region'sNlsN's role is superseded by the intervention of the OMlor 

OIG/OHI. The guidance is relatively flexible in law as to what extent an incident is 

reviewed by other levels in VHA when the VAMC has completed its inquiry. 

Guidance does exist for when incidents need to be reported to the Joint 

Commission on Accreditation of Healthcare Organizations (JCAHO). When an 

incident is considered as a ·sentinel event," although not a requirement, it is often 

reported to JCAHO and the VAMCs with more recent incidents have closely fulfilled 

this guidance. It appears that some VAMCs could well have reported the incident 

to JCAHO, but according to the documents provided, did not. The reporting of a 

·sentinel event" will involve the JCAHO in a special visit, and the VAMCs are 

generally expected to complete a root cause analysis. The specific definition of a 

sentinel event and when the option of reporting was established as a JCAHO 

guidance, is not immediately apparent and could be verified with JCAHO. 

Five of these 15 VAMCs stated that they had made a report to the JCAHO (Boston, 

Miami, Muskogee, Providence, and San Antonio) with the JCAHO conducting 

special site visits to assess the accreditation status. It is evident that four of these 

five VAMCs conducted careful and in-depth root cause analyses according to the 

documents provided. The JCAHO also visited Northampton, Temple, and 

Richmond to review their situations which may have been reported as sentinel 

events. 

In certain instances where there are blood transfusion errors, reports are made to 

the Food and Drug Administration (FDA). In the two instances where the 

mismatched blood transfusion was the obvious and proximate cause of death 

(VAMCs Boston and San Antonio), reports were made to the FDA. The other 

incident (VAMC Huntington) is less evident as to the need for a report to the FDA, 

and a report was not apparently filed. 
133 

4. 

Involvement of OMI andlor OHI: 

The stimuli for the OMI and/or OHI involvement in such incidents are variable. The 

RegionlVlSN may seek their involvement or other VHA officials, including the Under 

Secretary for Health. An OIG hotline or a congressional inquiry may also stimulate 

an OMI and/or OHI involvement. 

The OMI was involved with VAMC Temple, while OHI has been involved with 

VAMCs Richmond and Northampton. Respectively, the stimuli were a referral from 

a VHAIV ACO official, the OIG Hotline, and from OIG Investigations. 

In the other 15 incidents, the OMI was, or is, involved in 7 while OHI was involved 

in 3, while an addition 1 was handled by OIG Investigations due to a potential 

homicide investigation. In four VAMCs (Bay Pines, Boston, Huntington, and West 

Los Angeles), neither the OHI nor OMI have been involved in an inspection. 

It should be noted that the OHI has an oversight role with respect to inspections 

conducted by the OMI. It is a routine practice for OHI to review and comment on 

all OMI draft reports before the OMI issues them as final reports. 

Notification of "Family" and Next of Kin: 

It is generally required that the "family" and next of kin be notified of these possible 

misadventures in medical care. The understanding is that "communication" in of 

itself, is part of the treatment process, including admission of error, where 

appropriate. Review of the documents provided proved to be very difficult in 

determining the effectiveness of this process. Clearly a post hoc hotline or 

congressional inquiry complaint would tend to vindicate some breakdown in 

·communication." Also, the actual evidence for settling tort claims is not really 

found in the documents provided. 

General Impressions: 

The following are offered as general observations: 

• Almost without exception, each VAMC seriously engaged with the issues 

related to the incidents. 

• All VAMCs indicated immediate extensive investigation of the incidents, with 

possibly two exceptions. 

• The oversight by the Regions/VISNs, OMI and/or OHI have ensured that these 

untoward incidents are definitively and completely reviewed, with few 

exceptions. 
134 

5. 

• Most of the 1 5 V AMCs with specific incidents have responded by careful indepth inquiries which have resulted in several local policy changes. 

• VAMCs which have reported incidents to external agencies, such as JCAHO and 

FDA, seem to be most highly motivated to complete more extensive facilitywide performance improvements such as root cause analysis. 

• VHA RegionsNISNs and VACO did monitor these incidents, but it is unclear as 

to whether they have been accurately and consistently recorded on the DHCP 

data base. 

• The OMI and OHI, when inspections have been completed. have generally 

validated that the incidents were adequately managed, and in several instances 

confirmed an excellent response by the VAMC. 

Other Observations; 

It was the focus of the collection of information to not go beyond the incidents 

themselves to any great extent. The roll-up and trending of this and other data on 

risk management to be filed in DHCP is a very important function for a health care 

system such as VHA. It is unclear as to whether, from these untoward incidents, 

lessons have to be learned which would be useful to all VAMCs in the care of 

veteran patients. What corporate processes in the VISNs and at VACO can be 

clarified which will more likely ensure that systematic errors are not repeated? The 

assistive role of the VISNs and VACO, building the diligence at VAMCs to have 

robust risk management programs, needs to be evident and maximally effective. 

Prepared by: 

JOHN H. MATHER, M.D. 

Assistant Inspector General for 

for Healthcare Inspections 

September 17, 1997 

As amended September 26, 1997 
135 

STATEMENT OF 

ELWOOD HEADLEY, M.D. 

MEDICAL CENTER DIRECTOR FOR THE 

BOSTON VETERANS AFFAIRS MEDICAL CENTER 

ON PATIENT INCIDENTS 

BEFORE THE 

SUBCOMlI<UTTEE ON HEALTH 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

OCTOBER 8, 1997 

Mr. Chairman, members of the subcommittee, thank you for the opportunity to present 

details regarding this incident. As requested this testimony will discuss in detail the 

circumstances of the case, the nature and findings of the investigations which occurred 

and the remedial steps taken. 

CIRCUMSTANCES OF THE CASE: 

The patient was a 60 year old man with a history of esophageal cancer, who underwent 

an esophagogastrectomy (an operation to remove the cancerous esophagus and attach the 

lower esophagus to the stomach) February 13, 1996. This was complicated by a leak of 

the anastomosis (site of reattachment) and renal and respiratory failure. On March 5, 

1996 he was taken to surgery to have are-exploration of the right chest and drainage, 

repair of the anastamosis and a tracheostomy to improve ventilation. He was severely ill 

and the highest risk category patient. The procedure was only undertaken because of the 

life threatening nature of his problem. During the preced"re he suffered a cardiac arrest 

and attempts at resuscitation were unsuccessful and the patient expired. In the process of 

reviewing the circumstances surrounding Mr. Anderson's death it was discovered that he 

had received two units of packed red blood cells typed and cross matched for another 

patient. The Medical Examiner was notified and declined the case, however the family 

consented fer the autopsy to be performed by the Medical Center. Acute hemolytic 
136 

reaction secondary to incompatible ABO transtUsion was identified as the immediate 

cause of death. 

NATURE AND FINDINGS OF INVESTIGATIONS: 

Facl finding was instituted immedialely and an Administrative Boan! of Investigation 

was requesled immedialely and convened on March 8, 1997. II was chaired by the 

Director of Quality Managemenl and consisted of the Associale Chieffor Clinical 

Pathology and the Operating Room Nurse Coordinator. 

The Board was charged with the following responsibilities: 

a. 10 investigate the transfusion error of March S, 1996; 

b. to review the circumstances surrounding, and factors contributing to the error; 

and, 

c. to make recommendations to minimize recUITellce. 

In order to comprehensively review the incident the board tracked and evaluated what 

were fell 10 be essential aspects of care for this patient with regard 10 the blood 

transfusion including the: 

• identification of the patienl prior to and during the surgical procedure; 

• effectiveness by which information was communicated between the 

interdisciplinary team; 

• storage and handling of blood and blood products in the operating room; 

• adherence to policy and procedure associaled with the verification and 

administration of blood and blood products; 

• timeliness by which the error was identified, reported and appropriate follow 

up initialed. 

The following individuals were called as witnesses: 

• The Attending Thoracic surgeon 

• The Attending Anesthesiologist 

• Three Operating Room Nurses involved with the case. 

• Blood Bank Supervisor 
137 

o Chief Anesthesia Section 

o CRNA involved with the case 

o One SICU Nurse 

In addition, policies and procedures related to Transfusions of Blood and Blood Products, 

Standard Texts relating to Blood use, the Patient Incident Review Program and the 

Integrated Risk Management Program were reviewed. In addition, the patient's medical 

record was reviewed and the operating room refrigerator for the storage of blood and 

blood products was inspected. 

FINDINGS: 

Identification of the patient prior to and during the surgical procedure: 

Each discipline (surgeon, anesthesia and nursing) identified comprehensive procedures 

for the identification of the patient prior to the procedure. Of note, however, this is not an 

integrated process. Each utilizes procedures that are specific to their discipline and 

conducts identification procedures as an intra-disciplinary, versus an inter-disciplinary 

process. 

Effectiveness by which in/ormation was communicated among tire interdisciplinary 

surgical team: 

Each discipline as appropriate, described comprehensive procedures for the 

communication of essential patient information that was shared among the members of 

the team at various points during the procedure, such as at the time of transfer of 

responsibility for breaks. According to testimony, the extent to which information 

specific to patient identification is integrated into this process may vary. Of note, in this 

case a nurse assigned to assist in the room did not participate in patient identification 

procedures; however, he subsequently participated in the verification of blood prior to 

administration. Consequently, the omission of checking the patient's lD (wrist) band, by 

those participating in the verification became critical. Members of anesthesia who 

participated in the verification of the blood also participated in the care of the patient who 

preceded this patient in OR #7 and had, by then, begun to confuse the two patients. This 
138 

was further precipitated by the storage of the previous patient's blood in the refrigerator 

marked for OR#7 following completion of the case and his transfer to the recovery room. 

Because patient identification procedures are conducted by individuals rather than by the 

"team" without any subsequent interdisciplinary verification, this aspect of 

communication was felt to be less than optimal. 

Storage and handling of blood and blood products in the operating room: 

I 

Blood and blood products are stored in the operating room refrigerator by room number, 

based on the operating room schedule and case assignment for a given day. Of note, as 

stated above, another patient's blood was located in the section of the refrigerator 

compartment marked as OR#7. Both the patient and the previous patients procedures 

were performed in OR#7 with blood ordered for both cases. The patient's blood was later 

found to be stored and marked for OR#6. The exact process by which the blood was 

inaccurately stored in this instance could not be ascertained in spite of comprehensive 

review. 

The board feels that the storage of blood products and the identification of blood in the 

OR by room number rather than by patient increases the risk of errors. This aspect of 

care is not currently addressed in any existing policy or procedure. 

Adherence to policy and procedure associated with the verification and administration 

of blood and blood products: 

Policy and procedure clearly state that the verification process requires the confirmation 

of patient identification as reflected on the ID (wrist) band. This step was omitted during 

the verification process used for both units of blood. 

Timeliness by which the error was identified, reported and appropriote follow-up 

initiated: 

The timeliness by which appropriate follow-up, according to established protocol, was 

initiated was less than optimal. This included notification of the blood bank, notification 
139 

of the Chief of Staff or Risk Management and the initiation of the protocol for suspected 

blood transfusion reaction. 

Based on testimony, notification and follow-up was delayed because of a lack of 

knowledge on the part of the medical staff. Both consultants (surgeon and anesthesia) 

reported the incident to their Section and Service Chiefs in a timely manner, however, 

there was a significant delay in the information reaching either the Blood Bank or Quality 

Management Office in accordance with established policy. 

CONCLUSIONS: 

The transfusion error was directly attributable to human error. If the verification process 

included the confirmation of patient identification as reflected on the ID (wrist) band, the 

incident could have been avoided. 

While the transfusion error was clearly the result of human error there are opportunities 

to improve existing policy and procedure and minimize the risk of recurrence. 

The Surgical Service was less than timely in reporting this incident in accordance with 

established policy. 

REMEDIAL STEPS TAKEN: 

In addition to the Administrative Board of Investigation summarized above, a Root Cause 

Analysis was performed which is a method of reviewing processes as an aid to 

restrucruring them. No new information was introduced as a result of the Root Cause 

Analysis, it merely assisted in planning the remedial actions. Based on the results of the 

Administrative Board and the Root Cause Analysis it was decided to re-engineer our 

blood and blood products policies and procedures and the following steps were 

implemented. 

Letters of reprimand were issued to the Anesthesiologist, the Certified Nurse Anesthetist 

and the Nurse involved. 
140 

There was a redesign of the process to assure interdisciplinary verification of patient 

identification prior to the initiation of anesthesia or procedure and prior to the 

administration of Blood or Blood Products. 

There was a redesign of the process to a unifonn system of dispensing blood to the 

operating room by individual patient rather than in bulk and eliminating storage of blood 

outside of the Blood Bank, minimizing risks to patients. 

There was a change in policy to require documented infonned consent for blood 

transfusion medical center-wide to facilitate active involvement of patients in treatment 

decision-making processes. 

Educational programs addressing all of the above were instituted hospital-wide with 

special emphasis on the operating room. 

Educational programs on Risk Management were presented hospital-wide with emphasis 

on the operating room. 

An annual review of blood and blood product administration was instituted in the 

hospital's ongoing clinical staff education program. 
141 

STATEMENT OF 

T. C. DOHERTY 

MEDICAL CENTER DIRECTOR FOR THE 

MIAMI VETERANS AFFAIRS MEDICAL CENTER 

ON THE VETERANS HEALTH ADMINISTRATION'S 

POLICY AND PERFORMANCE 

RELATING TO SPECIFIC PATIENT INCIDENTS 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON VETERANS' AFFAIRS 

U. S. HOUSE OF REPRESENTATIVES 

OCTOBER 8, 1997 

Mr. Chairman and Members of the Subcommittee: 

I appreciate the Subcommittee's consideration of the serious case before it today. 

In June 1996, Mr. John Floyd Martin, a hemodialysis patient being treated by the V A for 

more than 25 years, died during one of his dialysis treatments at the Miami V A Medical 

Center as a result of a massive blood loss. When informed of Martin's death, I 

immediately convened a Board of Investigation. Later, a Root Cause Analysis was 

completed. A brief summary of the nature of the circumstances of the case; the findings 

and conclusions related to the case; and the remedial steps taken follow. 

It should be noted that prior to the tragic death of Mr. Martin, the outcome statistics for 

the Miami V AMC Dialysis Unit were above the national average, and our mortality rates 

are below the national average. In addition, there had been no adverse events related to 

staff performance in the estimated 135,000 dialysis treatments that have been performed 

since the unit opened in 1966. 
142 

I. Nature of the Circumstances ofthe Case. 

On Saturday June 22, 1996, the dialysis nurse who was scheduled to give Mr. Martin his 

dialysis treatment arrived a few minutes late for duty. She immediately proceeded to 

connect Mr. Martin to the dialysis machine. She observed a problem with the venous 

pressure transducer. Unable to resolve the transducer problem, the nurse requested 

assistance from a dialysis technician. They worked together to correct the problem. 

During this process, the dialysis nurse was notified that she had a telephone call. She left 

the bedside to answer the telephone in the nurses' station. The dialysis technician 

remained at the bedside, troubleshooting the machine. The nurse completed her call and 

returned to the bedside. The technician replaced the transducer and was leaving the area, 

when she heard a hissing sound. She returned to the patient's bedside and observed blood 

overflowing from the 2·liter collection container located on the side of the dialysis 

machine. The nurse and the technician investigated and discovered that the venous 

dialysis Hne was not connected to the return port in the patient's vascular access. The 

primary nurse had failed to connect the venous line to the patient. This resulted in the 

loss of more than 1800cc of blood. The nurse and the dialysis technician then attempted 

to replace the blood loss with large amounts of physiologic saline. 

The dialysis technician proceeded to clean up the blood spill. The blood-filled container 

was removed from the dialysis machine for disposal by the dialysis technician who called 

a second nurse to show her the blood-filled container and informed her that the blood was 

Mr. Martin's. The second nurse immediately rushed to Mr. Martin's bedside to assist. 

The technician emptied the container of blood and returned to the bedside to complete 

eleamng the area. 

The patient appeared to stabilize briefly after the administration of saline. During the 

course of these events, one of the above-mentioned three staff members obtained a blood 

sample and sent it to the laboratory for determination of hematocrit. 
143 

An employee ofthe Enviro.lInental Management Service arrived on the Dialysis Unit at 

approximately 7:15 a.m. and proceeded to clean the area. He stated that he spoke to Mr. 

Martin when he first approached the bedside and that the patient responded to his 

greeting. He stated however, that when he left the area, "the patient didn't look good." 

The patient's condition began to rapidly deteriorate. A third dialysis nurse was called to 

the scene from,la separate room to assist with the care of the patient. She was not 

informed of the blood loss. Shortly thereafter, at approximately 7:30 a.m., a dialysis 

nurse called a code. 

The coo, tearn physician reported that when he arrived on the scene, the other tearn 

members had already started the appropriate life saving measures. He stated that he 

questioned the staff at the bedside as to what had happened. He was told that the patient 

had developed abdominal pain followed by hypotension (low blood pressure). All three 

individuals (Mr. Martin's nurse, the second dialysis nurse, and the dialysis technician) 

knowingly withheld information concerning the blood loss from the code tearn. 

Knowledge of the loss would have been of great importance to the tearn in the proper 

assessment and management of the patient. At no time during the code did anyone ofthe 

three caregivers inform the code tearn that the patient had lost a large quantity of blood or 

that it was replaced with physiologic saline. The patient was pronounced dead at 8:25 

a.m. June 22, 1996 by the code tearn physician. 

At approximately 9:30 a.m., the nephrology fellow questioned the nursing staff involved 

in this incident. They failed to advise him that the patient had lost blood, or to provide 

him with the flow sheet documentation of the dialysis treatment. The staff also failed to 

notify the Chief of the Nephrology Section of the blood loss when he questioned them at 

approximately II :30 a.m. 
144 

On the morning of the incident, Mr. Martin's primary nurse called her supervisor (the 

Nurse Manager of the Dialysis Unit) at home and informed her about the incident. There 

is conflicting testimony as to what was actually relayed during the conversation. 

The sLcond dialysis nurse called the Nurse Manager of the Dialysis Unit at home the 

following day to inform her of the extent of the patient's blood loss. The Nurse Manager 

of the Dialysis Unit instructed the second dialysis nurse to report to work on Monday, 

June 24,1996 (her scheduled day oil) to further discuss this incident. 

The Nurse Manager of the Dialysis Unit failed to inform her supervisor of the incident 

until the afternoon of Tuesday, June 25, 1996. 

II. Findings and Conclusions Related to the Cas •• 

Proximate factors contributing to Mr. Martin's death were massive blood loss and the 

cover-up ofthe blood loss. In addition, there were other factors that are believed to be 

related to this tragic event. 

A. The Massive Blood Loss. 

1. The patient lost in excess of 1800cc of blood during his dialysis 

treatment over a period of approximately 10 minutes between 6:45 

a.m. and 7:00 a.m. This blood loss occurred because Mr. Martin's 

nurse failed to close the dialysis blood circuit. 

2. In addition, Mr. Martin's nurse left the patient's bedside during the 

critical set-up phase of the dialysis treatment, without assuring 

appropriate care of the patient. 

B. The Cover-Up of the Blood Loss. 

Mr. Martin's nurse, the second dialysis nurse, and the dialysis technician 

were negligent when they attempted to handle the emergency upon 

discovery of the blood loss, without immediate notification of a physician, 

and when they did not inform the Code Team about the massive blood 

loss. 
145 

C. Other Related Factol$. 

1. The Nurse Mauager of the Dialysis Unit failed to notity proper 

authorities in a timely manner. 

2. The Dialysis Unit that was operational at the time of the incident 

was separated into two main areas that were divided by a corridor. 

The geographical division did not pennit optimal observation of all 

patients by all staff members. 

III. Remedial Steps Takoa. 

A. 

B. 

I. 

Personnel Actions. 

Mr. Martin's nurse, the second dialysis nurse, the Nune Manager, 

and the dialysis technician were immediately removed from the 

Dialysis Unit, pending the outcome of the Investigation. 

2. Mr. Martin's nUl$e was terminated and the State Licensing Board 

was notified. 

3. The second dialysis nurse was suspended for 30 days and 

permanently reassigned. She resigned. 

4. The Nurse Manager of the Dialysis Unit was suspended for 14 

days, and wu"reassigned. 

s. The dialysis technician was suspended for 14 days. 

Other Remedial Actions. 

1. Dialysis treatments were moved to a newly constructed Dialysis 

Unit, which had been planned prior to the incident. This provides 

increased accessibility and visibility of staff to patients. The open 

design of the new unit pennits staff to assist each other in the event 

of an emergency while ensuring patient privacy. 

2. A total reorganization ofnuning staffwitbin the Dialysis Unit, 

including a new nurse manager and four new staff members, has 

taken place following the death of Mr. Martin. 
146 

3. The critical set-up process for dialysis has been redesigned to 

ensure a more uniform approach among all staff members and with 

all patients. A flow sheet was developed during the Root Cause 

Analysis to graphically represent the critical elements in the set-up 

process, particularly those involving the clamping of venous and 

arterial lines. The flow sheet clarilied the need for nurses to stay 

with the patient throughout the critical phase of the treatment and it 

is displayed at each patient's dialysis treatment location. Ongoing 

monitoring of the revised critical dialysis set-up process has been 

initiated. Since the onset of the tracking, there has been 100% 

compliance with the set-up process. 

4. Leadership issues on the Dialysis Unit have been addressed. 

Specilically, leadership training for the recently hired Nurse 

Manager and for designated charge nurses has been instituted. 

One-on-one mentoring for both the Nurse Manager and the charge 

nurse by the Associate Chief Nurse (ACN), Special Care has been 

ongoing. The nurse manager has received a formal supervisory 

training course from Human Resources specialists. The charge 

nurse and of all of the current RNs are participating in a nationally 

developed basic leadership development program which is being 

held over a six-month period. 

5. Meticulous attention to all aspects of conformance to policies and 

procedures has been in effect since this tragic incident even though 

prior to Mr. Martin's death, monitoring activities did not reveal 

evidence of inappropriate patient care. Dialysis staff members 

have received on-going staff training in administrative policies and 

procedures, emergency procedures, dialysis procedures, incident 

reporting, and accepting personal telephone calls. Subsequent to 

the incident, all dialysis nurses have achieved certilication in 
147 

Advanced Cardiac Life Support (ACLS). Fifty percent of the 

current dialysis staff nurses have received national certification in 

Nephrology Nursing. Ethics classes for dialysis statI and others 

have been provided by The National Center for Clinjcal Ethics 

6. The Chief, Dialysis Unit; the ACN, Special Care; and the Nurse 

Manager of the Dialysis Unit meet regularly with all statImembers 

to ensure accurate communication. 

7. Modifications in the culture of the Dialysis Unit have been made. 

The new dialysis team is functioning emctively to provide safe, 

competent care to veterans. The entire imerdisciplinary dialysis 

tearn collaborated to revise and improve the dialysis order forms 

and documentation forms and to update 100% of the dialysis 

policies and procedures utilizing the most recent dialysis science 

data. All registered nurses on the Dialysis Unit are reviewing 

patient charts as part of the peer review process to ensure 

continued quality. Patients, when questioned, express satisfaction 

with their care. A plan for all members of the interdisciplinary 

dialysis team to participate in a tearn-building program presented 

by Project ChallCOie is underway to advance the positive, cohesive 

tearn spirit that has been developed. 

IV. Conclnsion. 

From Mr. Martin's death. we at the Miami V AMC have learned many lessons. We have 

taken remedial personnel actions, have improved the Dialysis Unit's operating 

\ 

procedUres, and have conducted intensive education and training of staff members. 

Again, thanlc you for allowing me to explain the circumstances surrounding this tragic 

deviation from the high quality care that bas been the hallmark of the care provided to our 

veteranS in the thirty..one years since the Dialysis Unit opened. 
148 

STATEMENT OF 

BILLY M. VALENTINE 

MEDICAL CENTER DIRECTOR FOR THE 

MUSKOGEE VEtERANS AFFAIRS MEDICAL CENTER 

ON THE DEATH OF A PATIENT AT A CONSTRUCTION SITE 

ON MAY 24,1996 AT 

THE V AMCMUSKOGEE, OKLAHOMA 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

OCTOBER 8,1997 

Mr. Chairman and Members of the Subcommittee: 

I appreciate the Subcommittee's weighty responsibility for oversight of the VA healthcare 

system and fully understand concerns regarding uncommon, isolated events reSUlting in a 

patient's death. 
149 

The staff of the medical center were deeply saddened by the untimely death of the patient. This 

tragedy was highlighted in various news medias and provoked anxiety among the staff for 

many months. Although an unfortunate event, it was the only such accident that has occurred 

of its nature having to do with patient safety. The coverage of this isolated incident far 

outshadowed the compassionate care delivered by our staff each and every day to hundreds of 

veterans. In keeping with our mission, our staff continue to "provide personalized, high quality 

care with dignity and compassion." 

The patient was a 65 year old male with an admitting diagnosis of gastrointestinal bleeding and 

chronic alcohol abuse. He was brought to the Emergency Care and Treatment area at the 

Muskogee VAMC at 7:15 p.m. on May 22,1996, complaining of abdominal pain, nausea, 

vomiting and diarrhea for two to three days. He had a history of chronic alcohol abuse and had 

alcohol on his breath. Vital signs were taken. A naso-gastric tube was inserted, intravenous 

fluids were begun with intravenous famotidine (Pepcid) and he was transfused with two units of 

red blood cells. He received one injection of 50 mg of chlordiazepoxide (Librium) for 

restlessness. On May 23, 1996 the naso-gastric tube was removed. He was able to take clear 

liquidS by mouth and was allowed out of bed in a wheel chair. On May 24, 1996, he was 

further improved and stated he was hungry. He was started on oral feedings with 

supplementary potassium and phosphate and begun on oral famotidine (pepcid). 

The patient's medical condition had improved significantly since his admission. He had 

interacted appropriately with staff. He was judged to be appropriately oriented as to place, time 

and person. He was receiving no sedation, relaxants, or psychoactive medications. He was 

growing increasingly independent from his wheel chair, using it only for short rest and usually . 2 
150 

walked behind it. Staff were sure that the patient was oriented and competent to make his own 

decisions. 

Prior to the time of the incident, his hospital stay was uneventful, with all activities of care well 

coordinated and timely. On May 24,1996, around 10;30 p.m., the patient left the ward without 

infonning the nurses, possibly to smoke. This patient was a smoker and left the ward on 

several occasions to smoke. When he did not return within approximately IS minutes, a search 

was conducted but the patient was not located. On May 25,1996, at around 8 a.m., the patient 

was found dead in the construction site. 

The local Muskogee police and the VA police both investigated the incident immediately. The 

Medical Center convened a Board ofInvestigation June 3-7,1996, and the Office of the 

Medical Inspector conducted a site visit on June 26-27,1996. 

The local police department investigated the death and ruled it accidental. The Board of 

Investigation and the V AMC police also found the death as accidental. 

Findings of the AdministralIve Board oflnvestigation resulted in the following 

recommendations and subsequent actions by management. 

a) All patients are to be assessed for risk of wandering or falls at the time of 

admission and reevaluated routinely. This is to be documented in the medical record. 

(Managerial response - Policy was revised to ensure all patients were assessed for wandering 

3 
151 

and/or falls and that medical records indicate the assessment. There is ongoing monitoringfor 

compliance.) 

b) The instructions provided to patients upon admission should be documented in 

the medical record, including instructions regarding appropriate smoking ateas. (Managerial 

response - Documentation of orienting the patient to this requirement is reflected on the 

NurSing Admission Assessment Form and on the MUltidisciplinary Patient/Family Education 

Safety Tracking Flow Sheet.) 

c) All patients should be'cautioned to avrd all areas adjaCejt to the construction 

site. (Managerial rl$pdnse- A ietter wks developed stating the dangers. This letter continues 

to be distributed to every patient entering the medical center and is'posted throughout the 

medical center.) 

d) All staff with the potential to serve as a coordinator in a missing patient search 

should receive annual training on V A and medical center search policies and procedures. 

(Managerial response - This has been addressed in the new policy. All staff have received 

formal education and will receive annual updates.) 

e) In addition to the interim recommendations made by the Safety Committee on 

5/28/96, a formal assessment of the environment of care should be made in the areas of 

security, life safety and construction management. (Managerial response - Formal assessments 

were completed and are contained as Tabs 13, 14. and 15 in the documents submitted to Mr. 

Cliff Sterns.) 

f) Signage indicating "This door locks automatically behind you" should be placed 

on all applicable exit doors. (Managerial response - Appropriate signage was developed and 

installed.) 

g) Policies (i.e., MCMs and service-level) pertaining to search procedures should 

be reviewed and modified as needed to minimize any potential areas of ambiguity or 

weaknesses. (Managerial response - New policies were developed and continue to be revised 

as necessary. An inservice for all staff on the new policy was conducted by the Safety and 

4 
152 

Occupational Health Manager and incorporated in the annual training program. See Tabs 21 

-26.) 

Following the Administrative Board of Investigation, the Office of Medical Inspector (OMI) 

conducted an investigation. This was in response to the family's request for an investigation 

from OMI. In response to this request the Deputy Under Secretary for Health asked the 

Medical Inspector to determine if the V AMC's actions prior to and subsequent to the death 

were in compliance with V A policy and to review the Board of Investigation's report and other 

evidence to determine if a full site team visit and investigation by the OMI were needed. 

The OMI reported the following findings in their final report dated February 12, 1997, which is 

contained in the reference book sent earlier to the Subcommittee. 

The OMI determined that prior to the event of May 24, 1 996,the patient had been allowed 

appropriate independence in movement. It was on that date the patient found himself locked 

out of the hospital when he went outside to smoke. While other options for reentry were 

available, such as calling for help from a telephone in a well-lit smoking shelter or waiting in 

the smoking shelter until someone came looking for him, he apparently tried to find a path back 

to the front door. "After squeezing through the seam between two sheets of construction 

fencing," (it was later determined he had unfastened metal ties connecting the fence), he walked 

around part of the perimeter of a construction hole. He fell 35 feet into the construction hole 

where he was impaled on an uncapped steel rebar imbedded in concrete. His decision to force 

his way into a construction site, which was clearly marked as dangerous, exposed him to the 
153 

hazards that resulted in his death. Maintenance of the construction site by the independent 

contractor was brought into question by the Board of Investigation; however, some of the 

citations and findings of that Board were corrected or questioned by the VHA Chief of 

Facilities Maintenance Officer and found to be unsubstantiated. 

The patient's absence was almost immediately noted by the ward staff, and search procedures 

were implemented. The patient, however, was not found until the next morning. 

The Office of Medical Inspector found that the Medical Center and loeal police conducted 

complete and thorough investigations. 

Based on the review by the Medical Center and OMI's concurrence with the Medical Center's 

findings, the following recommendations were made: 

1) All doors, which lock behind those exiting should be clearly marked as such. In 

the event that a patient, staff, or visitor is inadvertently locked out, instructions on how to 

regain entry should be posted on the outside of the door. (Managerial response - All exit doors. 

which lock behind those exiting. have been clearly marked.) 

2) Search procedures should be expanded to include any closed-off construction 

areas to determine if the perimeter is intact. (Managerial response - The Medical Center 

Search Policy was revised to include a search of the perimeter of any construction area.) 

6 
154 

3) All hazardous areas, such as construction sites must be fully lighted at night. 

(Managerial response - The construction area is illuminated by a flood light The Medical 

Center Search Policy includes a search of all construction sites. Corrective action was taken 

immediately following the incident.) 

4) Consideration should be given to requiring patients to sign out when leaving the 

ward, at night and on weekends. (Managerial response - Patients are required to sign out 

when leaving the ward. Monitors are in place to ensure compliance. Corrective action was 

taken immediately folloWing the incident.) 

5) Medical Centers should develop a mechanism to limit acute care patients, who 

wish to smoke, to designated smoking areas outside the building. (Managerial response -

Orientation for patients pertaining to the Medical Center Smoking Policy, location of patient 

smoking shelters and uses of sign-out sheets was implemented as a result of the Medical Center 

Administrative Investigation. Appropriate nursing staff received education and trainingfor 

this orientation.) 

Recommendations were made to VHA to incorporate much of what was recommended to the 

V AMC into V A policy. All V AMCs should be directed to review the foregoing 

recommendations as an alert to prevent a similar tragic accident. 

The Medical Center took immediate action to comply with all recommendations set forth in the 

administrative investigation and the Medical Inspectors Report. As indicated in the reference 

material sent to the Subcommittee earlier, and in my testimony today, search policies were 

7 
155 

followed appropriately. Policies have been modified to delete any areas which may have been 

ambiguous and training for the entire staff of the Medical Center has taken place and will 

continue to be a part of the annual training each Medical Center employees goes through. 

Our Risk Management Program is aimed at improving the quality of care through identification 

of system design flaws and other problems and redesign of patient care systems to decrease the 

likelihood of deviations that can harm patients. Our Medical Center, like all medical centers 

and VISNs throughout the country is in the process of revising our Risk Management Program 

to comply with the new National Risk Management Directive and the VISN 16 Risk 

Management Policy. We have a designated Quality Management Specialist who serves as our 

facility's Clinical Risk Manager and a full time Safety Officer. We participate in an exchange 

process whereby we have the benefit of review from other V A facilities and also perform 

reviews for them when requested. We have a formal process, which follows the guidelines set 

forth in the National Risk Management Directive for reporting any events that are, or may 

become, high profile to our VISN within 24 hours. In addition, the Quality Managers from 

VISN 16 had a meeting in Dallas where our Quality Manager gave a presentation on Risk 

Management related to these events. So as you see we have an elaborate and extensive network 

for reviewing, improving, and evaluating our potential for risk. As directives are finalized, staff 

will be educated on the changes. 

It is unfortunate that this accident occurred, and we have taken steps to minimize the possibility 

of any reoccurrence. 

g 
156 

POST-HEARING QUESTIONS 

CONCERNING THE OCTOBER 8, 1997 

HEARING ON VHA'S RISK MANAGEMENT 

POLICY AND PERFORMANCE 

FOR KENNETH W. KIZER, M.D., M.P.H. 

UNDER SECRETARY FOR HEALTH 

DEPARTMENT OF VETERANS AFFAIRS 

FROM THE HONORABLE LANE EVANS 

RANKING DEMOCRATIC MEMBER 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

Question 1: How does V A track and trend malpractice suil' and 1151 claims taken 

against V A or its agents? Please provide a profile of the number of each type of action 

brought against V A and their dispositions. Also. please provide an estimate of the costs 

of malpractice and 1151 benefits to V A each year. 

Answer: The Office of General Counsel maintains a system· wide database that is 

designed to track all claims filed with the Department of Veterans Affairs pursuant to the 

Federal Tort Claims Act (FTCA). The system is called the Tort Claims Information 

Syslem (TCIS) and follows the progress of both malpractice and non-malpractice claims 

from the date they are received until final disposition administratively or by litigation. 

V A' s medical malpractice experience for the past decade is detailed in the attachment 

According to the Compensation and Pension Service of the Veterans Benefits 

Administration, claims filed with V A pursuant to 38 U .S.c. § 1151 are entered into the 

Target system with the special law code of 07, and VBA is able to retrieve the number of 

1151 claims for any month or period of months. With the Supreme Court decision in 

Brown v. Gardner, 130 L.Ed.2d 462 (1994), the number of living section 1151 recipients 

increased dramatically from 479 in September 1993 to 2,182 in September 1997. The 

sum paid out increased from $436,008 per month in September 1993 ($5,232,096 per 

year) to $2,301,229 per month in September 1997 ($27,614,748 per year). In addition, 

there are another 690 monthly recipients of Dependency and Indemnity Compensation 

based upon section 1151 awards. The monthly payout on these cases is $595,454 which 

amounts to $7,145,448 per year. 

Question 2: Roughly, how much docs VA spend to measure and monitor quality in the 

health care system? Do you have any idea on how its spending on measures to enhance 

quality compare to spending for other health care providers? 

Answer: It is not possible to fully answer your question because measuring and 

monitoring quality is an inherent responsibility of all caregivers and managers in the 

system, but the specific time or percent of their effort devoted to such efforts varies by 

position and over time. 

Within VHA headquarters, two offices are specifically devoted to measuring and 

monitoring quality: the Office of Performance and Quality (105A) and the Office of the 

Medical Inspector (IOMI). For FY 1998, total salary costs for these two headquarters 

offices are approximately $1 ,426,000. The Office of Performance and Quality also 

monitors quality through field programs, special contracts, and granL •. These include for 

FY 1998: 

Paticnt Advocacy Program at Danville, IL V AMC 

Data Resource Center at Durham V AMC 

National Customer Feedback Cenler at W. Roxbury, MA V AMC 

External Pecr Review Contract 

Joint Commission on Accred of Healthcare Orgs Contract 

Inlerqual (Utilization Management) Contract 

Functional Status Project 

Total Field, Contract, and Grant 

$188,000 

1,345,000 

1,304,000 

7,300,000 

2,800,000 

245,000 

413 000 

13,595,000 
157 

Total travel costs to support all of these programs are approximately $760,000, and the 

bulk of this goes to field sites to support travel by field staff. Total Headquarters costs 

identified for the two offices whose mission is to monitor and measure quality of care for 

FY 1998 are as follows: 

Headquarters Salary 

Field Programs. Contracts. and Grants 

Travel 

Total 

$1,426,000 

13.595,000 

760000 

$15,781,000 

These costs do not include the oversight responsibilities of other Headquarters elements 

such as Patient Care Services (II) where a substantial amount of staff time is spent in 

activities that could be defined as monitoring and measuring quality of care. Further, 

these costs do not include the many field staff who devote their time to monitoring and 

measuring quality of care. Currently, the Office of the Inspector General is conducting a 

review of VHA's quality management programs, with part of that review involving an 

effort to determine the amount of staff time spent in monitoring and measuring quality 

activity. We understand that the OIG review is scheduled for completion in December 

1997. VHA is not able to compare its costs with the private sector, since this information 

is considered proprietary and is not publicly available. My personal impression, as a 

former state regulator of over 5,000 healthcare facilities, as a private consultant on 

healthcare quality issues, as a senior faculty member involved in quality of care issues at 

a large academic health center, and as a medical practitioner in a wide variety of settings 

is that V A devotes considerably more resourees and efforts in this regard than most other 

healthcare systems. 

Question 3: We heard testimony from three of your facilities that are tragic examples of 

preventable deaths. Are you generally satisfied with the manner in which these directors 

reviewed and corrected systemic deficiencies that lead to the dire incidences that 

occurred? 

Answer: I am never satisfied when events like those which you reference occur. Having 

said this, I should also say that the directors at the three V A Medical Centers who 

testified at the House Veterans Affairs Committee Hearing on October 8,1997, 

thoroughly reviewed the incidents and implemented corrective actions. These actions 

were directed at preventing future similar incidents from occurring. Each of the medical 

centers established interdisciplinary teams to conduct the intensive investigations. The 

investigations and resultant action plans focused on systems and process defects that 

allowed the incidents to occur. While the manner in which each of the directors reviewed 

and corrected the systemic deficiencies leading to the incidents was satisfactory, four 

additional enhancements of the process have been implemented to further assist them: 

\. The new Risk Management Directive (VHA Handbook 1051,9/25197) provides 

additional guidance to V A facilities in the process of analysis of adverse events. 

2. A Risk Management Oversight Committee meets biweekly at VHA Headquarters to 

review all of the investigations of these serious events carried out by V A medical 

centers. The Committee provides feedback to them regarding the need for any 

additional information. The Committee along with the medical center and the 

respective network identifies and develops "lessons learned," as appropriate for 

distribution throughout the VHA system. A Lessons Learned Intranet database is 

being developed for application of information V A wide. 

3. A Sentinel Event Registry has been established for the benefit of the entire VHA 

system. The Chief Network Officer maintains the registry in VHA Headquarters. All 

serious adverse events are logged and tracked electronically, so that, in time, staff at 

each medical center may access trended data to determine possible patterns. 

4. The Office of the Medical Inspector (OMI) also reviews each Board of Investigation 

and Focused Review, for compliance with policy, for completeness, for timeliness, 

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for trending, for further review, for identifying a need for an OMI investigation, and 

for any additional lessons learned. 

I believe these four enhancements will improve the process by which each serious 

adverse event is used for future systemic improvements, and hopefully help to reduce the 

overall number of serious adverse events to a minimum. 

Question 4: Please briefly describe how VHA's new risk management plan differs from 

the plan that was previousl y in place. 

Answer: There are many significant differences between the new policy and the 

previous one. Some of the most important are that the new policy is based on the most 

rigorously conducted research on patient safety, emphasizes identifying and revising 

system designs that have led, or that may lead, to practitioner errors and adverse events, 

establishes a clearly defined oversight role for the networks and Headquarters in the risk 

management process, and includes a mechanism for sharing lessons learned from the 

review of adverse events between facilities. The requirement in the new poliCY that most 

clearly differentiates it from the previous policy is the implementation of a systematic 

monitoring process, involving the facilities, networks, and Headquarters. This 

monitoring process is described in the response to Question 5. 

Question 5: VA's Risk Management directive indicates that it will establish a systematic 

monitoring process. What does this entail? 

Answer: The systematic monitoring process involves facility review of all adverse 

events with significant consequences (as well as near-misses) to identify the underlying 

causes and needed system redesigns. Facilities are required to address 10 specific 

questions that focus on improving patient safety in their assessment of each adverse 

event. The assessments are reviewed by the VISNs and the Risk Management Oversight 

Committee in Headquarters to trend the frequency with which particular care delivery 

systems have been problematic, identify needed changes in policies and procedures, and 

identify system redesigns requiring further review and development. Insights gained 

from this process that may be useful to other facilities are shared through VHA's Lessons 

Learned Database on the V A Intranet. In addition, all adverse events and subsequent 

reviews will be transmitted to a central data repository that will be regularly analyzed by 

VISN and Headquarters staff. 

Question 6: Have you thought of how V A will balance correcting problems (which 

sometimes implies punitive action) while ensuring that employees are encouraged to 

report adverse data? 

Answer: In a 1996 national conference, "Errors in Health Care," Lucian Leape, a 

Harvard physician, educator, and researcher, stated in his keynote address that frequently 

errors are made by the best people-the best trained, the best educated, the best 

performing. It has been an unstated belief, according to Stahultz and Gosbee in the 

August 1996 edition of AmeriCan Medical News, that through medical education and 

practice, medical professionals Can be trained to be "infallible." The truth is 

unfortunately otherwise; humans have measurable limitations in memory, attention span, 

and physiological and mental endurance. Stahultz and Gosbee go on to say, " ... medical 

educators and clinicians must understand that human performance is not perfect and 

cannot be perfected by training. Then they must be taught to look for opportunities to 

modify systems .... " That is the direction of the new VA-focusing on correcting 

systems and not on punitive action toward individuals. 

While there are errors caused directly by willful acts of an individual, these are the 

extreme exception rather than the rule. The real gains to be made in the reduction of 

errOrs in health care are through identification and repair of systems errOrs. These 

systems errors are frequently the cause of why the best people commit errors, according 

to Leape. Within the document, Journey of Change, the need for VHA to be an 

exceptionally accountable organization is stressed. Within that need for accountability, 

reporting of errors is part of the individual ethical behavior expected of all VHA workers. 

3 
159 

It is only through identification and reporting of errors that we can begin the process of 

reducing them. 

Within the VHA. the Office of the Medical Inspector is frequenUy involved in reporting 

error and making recommendations to reduce error. That office never recommends 

individual sanctions, but, instead, focuses on the systemic causes. This is a philosophy 

we hope is spreading throughout the VHA. 

Having said these things, any suggestions that you might have to facilitate the right 

balance would be welcome. 

Question 7: Your policy cites a study that found that 18% of all hospitalizations are 

subject to an adverse event resulting in serious injury. Are there any data to indicate how 

V A compares to the private sector in the occurrence of adverse events. 

Artswer: There are no studies that have applied the same definitions and data collection 

procedures to V A and private sector care to compare the rates of adverse events. VHA 

has analyzed data on adverse events reported in its Risk Management program during FY 

1994 to 1997 and compared these rates to findings from research conducted in the private 

sector. A copy of this analysis is attached. Again, my personal impression (based on my 

past experience as noted in the answer to question 2) is that VA's experience compares 

very favorably. 

Question 8: How docs V A ascertain that its patients who arc harmed due to medical 

negligence or malpractice are informed about the error in their treatment? 

Artswer: V A 's new RM policy requires that staff inform patients and their families 

about all injuries resulting from adverse events, not just those adverse events involving 

medical negligence or malpractice, and also about their remedial options if the adverse 

event involves potential organizational liability. The Office of the Medical Inspector and 

the Office of the Inspector General are responsible for determining whether this and other 

policy requirements arc being implemented by facilities. This is a change from prior 

policy. 

Question 9: How many networks have developed policies for reporting adverse events? 

How arc you ensuring that the policy is developed and implemented? Do any networks 

offer models? What is VHA Headquarters role in overseeing the effective development 

and use of these policies? 

Answer: At the time of the October 8, 1997 hearing, not all VISNs had issued a VISN 

Risk Management policy. Some were awaiting the issuance of the Risk Management 

Handbook which was issued by VHA Headquarters on September 25, 1997. Some 

VISNs have simply adopted the national risk management policy at the VISN level. The 

VISNs are in the process of setting up mechanisms to implement the risk management 

policy. Several have developed their own model risk management programs. These will 

be reviewed by the Risk Management Oversight Commiucc (RMOC) in Headquarters 

and shared with other VISNs. 

Many VISNs have designated a lead Risk Manager for the VISN to ensure consistent 

implementation of policy. The data is reviewed by the Chief of StaWClinical Advisory 

Councilor Executive Leadership Council. 

Risk Management is a topic that has been discussed on the Clinical Managers' weekly 

conference calls as well as their face to face meetings. To underscore the importance of 

risk management, the Network Directors' performance contract for FY 98 contains a 

performance measure on risk management. 

VHA Headquarters' role at present is providing guidance to the VISNs and field 

regarding the expectations of the risk management policy. A Senlinel Events registry has 

been established and reporting of events is being facilitated by the usc of MS Exchange 

which is now available at the facility level. The Risk Management Oversight Committee 

reviews each incident to identify the adequacy of the facility review, the prevalence of 

4 
160 

incidents and commonalties, system redesigns that should be adopted and shared 

throughout the system, and to identify lessons learned that can be shared on the Intranet 

database. To date, several facilities have been asked to develop lessons learned based on 

how they handled specific incidents. 

If you have specific suggestions on how you think this process should work, I would 

welcome your suggestions. We also are working with a consultant on this matter. 

Question 10: How does headquarters review and compare data rolled up at the national 

level? Do you feel that this is a timely and effective means of identifying potential 

problems? 

Answer: Currently, Headquarters analyzes aggregate data based on incident reports that 

are sent to the Hines Chief Information Officer Field Office. However, the value of these 

analyses is somewhat limited by the incident reports only including variables derived 

from the preceding RM policy. In addition, access to these data is limited to a small 

number of staff at the Hines Field Office. These problems will be remedied when the 

incident reporting software is upgraded. The upgrade will establish a national database 

that includes all relevant variables needed to adequately describe the adverse event as 

well as the results of the review that was conducted to assess the adverse event This 

database, which will be located at the Austin Automation Center, will be accessible to 

Headquarters and VISN staff as well as HSR&D researchers. 

These data should provide a timely and effective means of identifying RM issues 

requiring further evaluation and national efforts at system redesign. The data will also 

flag facilities with unusually high or unusually low adverse event rates for further 

assessment. Because of the difficulties involved in determining whether a high rate of 

reported adverse events represents poor quality of care or unusually good reporting (See 

response to Question 12), it will usually not be possible to definitively identify facilities 

providing poor quality care from these data alone. Intensive assessment of the facility, 

usually involving site visits, will often also be necessary. 

Question 11: Describe the role of the sentinel event registry in ensuring quality care. 

Answer: The sentinel event registry tracks those adverse events for which reporting to 

Headquancrs within 48 hours is required; this includes sentinel events and adverse events 

likely to generate substantial negative publicity or to lead to a JCAHO Visit for Cause. 

The registry is used by the Office of the Chief Network Officer to identify adverse events 

that require immediate alerts being sent to field facilities or that need to be brought to the 

attention of the Under Secretary or Deputy Under Secretary. It also enables that office to 

track whether appropriate review activities have been performed for these serious adverse 

events. In addition, the sentinel event registry is used by the Risk Management Oversight 

Committee to identify adverse events and system failures that have repeatedly occurred 

within VHA and require national efforts at system redesign. 

Question 12: Do you have an expected number of adverse events which helps you 

understand where facilities may be under-reponing? For example, if 0 reports were filed 

for a facility, would your reaction be, this facility is doing a great job or this facility is not 

identifying its adverse events? How do you know? 

Answer: Since the available studies indicate that adverse events are common in all 

healthcare settings, a repon of 0 adverse events for an extended period of time would 

certainly suggest under reponing. Since the research literature also indicates that under 

reporting is extremely frequent, it would not be immediately clear whether a large 

number of reported incidents signified unusually good reporting or poor quality of care. 

Intensive study, probably including a site viSit, and other evaluation, would be required 

and would be the approach taken by VA. Based on the research literature, under 

reponing probably occurs at all healthcare facilities and, thus, it is not necessary to 

establish a threshold to identify it. 

When the Risk Management directive was issued June 6,1997, there were many areas 

that required clarification based on field concerns. The recently issued Handbook 
161 

provides clarification, examples that provide clear guidance to facilities on what incidents 

should be reported. In addition, guidance is provided by Headquarters on the monthly 

Risk Management conference calls. 

Question 13: What is the private-sector standard for reporting practitioners to the 

National Practitioner Data Bank? Is V A's any different? If so, how so? 

Answer: The private-sector standard for reporting to the National Practitioner Data Bank 

(NPDB) is set forth in the Health Care Quality Improvement Act of 1986, Title IV of 

Public Law 99-660, and further delineated in Department of Health and Human Services 

(DHHS) regulations 45 CFR, Part 60, entitled National Practitioner Data Bank for 

Adverse Information on Physicians and Other Health Care Practitioners. 

There are two types of reports: 

I. Adverse Action Report - this report is filed when an action (reduction or 

revocation) which exceeds 30 days is taken against a practitioner's clinical 

privileges. 

2. Medical Malpractice Payment Report - this report is filed when a malpractice 

payment is made on behalf of a Licensed Health Care Practitioner. 

The V A makes both types of reports. The only difference is with regard to Malpractice 

payment reporting. The process for V A is different. For a private sector practitioner, 

when his/her malpractice insurance company makes a payment on a claim filed against 

the practitioner, the company which makes the payment also immediately files the form 

for NPDB reporting because the practitioner is the named defendant in the action. 

Because malpractice claims in V A are Tort claims with the defendant being the United 

States government, the V A performs a post-payment peer review to determine: 

a. the practitioner(s) responsible for the act/omission for which payment was 

made AND 

b. whether that act/omission constitutes substandard care, professional 

incompetence, or professional misconduct. 

Although the legislation establishing the NPDB was not binding on Federal Agencies, the 

V A voluntarily entered into a Memorandum of Understanding with the DHHS in 

Nuvember 1990, to participate in support of the spirit and intent of the legislation. 

Question 14: Systems design is to blame for most adverse events. For what systems has 

V A taken steps to improve design? (How many of the references in your Appendix A is 

V A implementing?) 

Answer: Based on the work of a national task force established to look at blood 

transfusion errors in the operating room, Dr. Kizer has recently approved a plan to 

implement bar coding procedures to match blood products against the patient's ID wrist 

bracelet prior to operating room transfusions. VHA expects to quickly expand this 

system redesign to all blood transfusions and is developing a plan to also implement bar 

coding in the medication administration process, because of its known effectiveness in 

reducing medication errors. We are also developing plans to have physician orders 

entered directly into computer terminals. We anticipate that this step, combined with the 

use of bar coding in medication administration, will significantly reduce the number of 

adverse drug events in OUf medical centers. 

Althe facility and VISN levels, plans are being developed to redesign a large number of 

other systems. These plans arc to some extent being driven by the Risk Management 

Performance Measure in the FY 1998 Network Directors' Performance Agreement that 

requires each VISN to implement a number of system redesigns of their care delivery 

systems to enhance patient safety. We anticipate that most of the issues listed in 

Appendix A of our Risk Management policy, as well as many other system issues, will 

have been addressed either nationally or by a number of VISNs by September 1998, 

which marks the end of the assessment period for the FY 1998 performance agreements. 

6 
162 

Question 15: How are you assuring that every layer of VHA knows that you, as its 

leader, are deeply committed to ensuring quality for the veterans who are your patients? 

Answer: As you know, I have made it a hallmark of my tenure as Under Secretary for 

Health to insist that veterans receive the highest quality health care available, and a 

consistent message to that effect has gone out to all V A employees. This message was 

first promulgated in 1995 in the "Vision for Change," a document that described the 

restructuring of the V A health care system. This was followed in 1996 by the 

"Prescription for Change," a document that laid out the five Mission Goals that are the 

strategic underpinnings of change in VHA: 

• Provide Excellence in Healthcare Value 

• Provide ExceHcncc in Customer Service 

• Provide Excellence in Education and Research 

Be an Organization that is Characterized by Exceptional Accountability 

• Be an Employer ,if Choice 

In 1997, the "Journey of Change" was published. This document describes the 

systematic approach being taken to meet slrategic and annual targets set for the 22 VHA 

Networks. This document outlines the Domains of Value that provide the framework for 

defining and measuring Excellence in Healthcare Value and Customer Service. 

All of the initiatives described in these documents come to life in annual performance 

agreements with the Network Directors. The requirements in these performance 

agreements filter through the organization and literally touch every employee. A primary 

mechanism for ensuring that my commitment to quality reaches all levels of the 

organization is the existence of performance measures in these performance agreements 

that require all employees to address the quality of their work-whether it be meeting the 

customer service standards or the rigorous technical requirements of complex surgical 

procedures. The message is getting there. For example, in a recent survey of VHA 

employees, fully 75% identified the delivery of excellent customer service as a critical 

component of VA's mission. We cannot be satisfied until 100% answer that way, but 

75% is a good start. 

In addition, I have personally lectured to staff on this subject and have effected a number 

of other policy and program changes aimed at enhancing and standardizing quality of 

care. Exemplative of these are the June 1997 requirements for board certification for 

physicians and, mQre recently, a similar requirement for medical center directors, 

associate directors and other VHA executive personnel; the "Clinical Programs of 

Excellence" program; various incentive awards; participation in the Institute of 

Medicine's National Roundtable on Quality; increased use and support for VA's National 

Biocthics Committee; and implementation of the Chronic Disease Index and Prevention 

Index. A number of other such efforts are currently at various stages of development. 

7 
163 

POST-HEARING QUESTIONS 

CONCERNING THE OCTOBER 8, 1997 

HEARING ON VHA'S RISK MANAGEMENT 

POLICY AND PERFORMANCE 

FOR DR_ ELWOOD HEADLEY 

DIRECTOR, VA MEDICAL CENTER, BOSTON, MA 

DEPARTMENT OF VETERANS AFFAIRS 

FROM THE HONORABLE LANE EVANS 

RANKING DEMOCRATIC MEMBER 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENT A T1VES 

Question 1: I fear that something must first go horribly wrong before VA assesses how 

to redesign systems to improve patient safety. Has your facility undenalcen any other reengineering studies since your root cause analysis of the evcnl~ that Jed to your patient 

being transfused with the wrong blood type? 

Answer: The Boston VA Medical Center. and VHA nationally. have historically been 

very aggressive in developing a risk management program that systematically collects 

data to identify areas that place patients. visitors and staff at risk. Data are tracked. 

trended and analyzed so that measures can be taken to redesign systems as appropriate to 

facilitate environmental safety. In many instances the data are computerized to facilitate 

local. network, and national trending and comparison. It is because of this type of 

ongoing systematic approach to risk assessment and management that sentinel events are 

a rare occurrence. Our goal has always been to minimize clinical risks to patients. When 

systems do fail. causing patient injuries, we very quickly conduct a comprehensive root 

cause analysis to identify and correct deficiencies to eliminate recurrence. While these 

unfortunate incidents clearly identify systems issues that warrant immediate action, they 

are by no means the only source of such information or impetus for process 

improvements. 

Long before the unfortunate error occurred, the medical center developed processes to 

systematically review designated aspects of care known to pose significant risks to 

patients such as: complex pharmacy and therapeutic agents: operative, invasive and 

other procedures: and transfusion medicine. Interdisciplinary committees systematically 

review and evahltte the quality and appropriateness of care using a proactive approach to 

risk a~essment and management. We recognize that there arc certain risks inherent in 

what we do and value the lives of each veteran we serve. In addition to internal review, 

each group tracks sentinel events that occur in private healthcare systems so that lessons 

can be learned before simi:ar events occur locally. For example: 

a. Patients on multiple medications are at risk for the drugs adversely interacting with 

each other. For years, the medical center has identified polypharmacy as an area of 

significant clinieal risk to patients, especially the elderly veteran population. Systems 

have been put in place to identify patients and medications at risk for drug-drug 

interactions. The system is computerized so that all patients receiving more than eight 

medications are automatically identified and medications are reviewed. These patients 

may be referred to a Pharmacy Clinic for medication review and extensive patient 

teaching to minimize the risk of complications from the medications and enhance the 

patient's understanding to assure that the medications are appropriately taken. In 

addition, regardless of the number of medications prescribed, certain drugs or 

combinations of medications are automatically flagged in the pharmacy computer system 

and reviewed before the prescriptions are filled, thereby minimizing the risk of an 

adverse event. Prescribing guidelines are readily available to all providers via the 

computer. Physician orders are initiated via the computer and the system is structured to 

limit dosing based on established guidelines which further decreases the risk for error or 

adverse reactions. Finally, there are stringent guidelines and monitoring processes for 

certain complex medications, such as chemotherapeutic agents, to avoid overdosing and 

causing devastating complications or death, such as that which was reported to occur in a 
164 

well known local private hospital. Our physicians report that there is currently no 

comparable system available in private health care facilities in the Boston arca. 

b. The literature shows that procedures in which any type of sedation or anesthesia arc 

involved also pose known clinical risks. There have been several unfortunate 

complications rcported in the media, especially within the private sector's pediatric and 

elderly population. The medical center has extensive processes in place to assure that 

care is uniform and safe in all areas in which procedures are performed andior sedation 

administered. Our Invasive Procedure Committee, for example, has established stringent 

guidelines to define minimum standards of care and practice to assure the appropriateness 

of indications for procedures and the selection of sedative agents; assessment of patients; 

monitoring patients during procedures; and providing follow-up care after procedures. 

Recognizing that medical technology and pharmacology change rapidly. and that illness 

within the veteran population is extremely complex, there was a redesign of systems to 

enhance patient care aimed at further minimizing clinical risks associated with sedation. 

These changes were done although the unexpected outcomes and complications observed 

at our hospital were minor in nature and represented a complication rate of less than 1% 

historically. 

A comprehensive educational program was developed for all staff involved in the 

administration of sedation or monitoring of patients who receive conscious sedation. 

Course content focuses heavily on the assessment of each patient's health status, 

pharmacology and airway management. All members of the medical staff must 

successfully complete the course and a post test to demonstrate competency before 

privileges are approved in this area. Because airway obstruction or compromise is known 

to occur in a percentage of cases, competency in airway management is an essential 

component of our educational and monitoring process. The use of sedation is closely 

monitored by the Invasive Procedure Committee, in conjunction with the Committee on 

Therapeutic Agents, so that any need for further system redesign is identified in a timely 

manner. We have developed provider profiles to track and trend individual performance 

regarding operative, invasive and other procedures. 

The medical center also participates in a VHA-national Surgical Quality Improvement 

Program. There arc local and national data on major operative procedures that is tracked 

and trended to identify possible systems issues that place patients at risk for 

complications. The data arc reviewed through our surgical case review process. 

Findings may result in system changes or in identifying topics for more comprehensive 

research designed 10 enhance patient care. Our surgical staff are integrally involved in 

research initiatives. 

c. The transfusion of blood and blood products is also known to have certain clinical 

risks. Although extensive monitoring processes associated with transfusion were in 

place, our systematic internal review did not identify any significant issues that would 

have warned us of the transfusion error prior to its occurrence. Our review systems were 

consistent with established community and JCAHO standards and there were no trends 

regarding lapses in policy or procedure known to contribute to such an error. We have 

since expanded the scope of our systematic review and have redesigned systems to avoid 

recurrence and facilitate the identification of risks, as previously reported. The review 

and evaluation of systems is ongoing through our Transfusion Committee and we will 

continue to be aggressive in pursuing opportunities for improvement. 

Question 2: Besides the steps you took to remedy the systems that fdled in the scenario 

you described in testimony, are there any other quality initiatives Boston has undertaken 

that you would like to share with the committee? 

Answer: Examples of quality initiatives, other than for blood transfusion, are provided 

in the response to question number one. However, there is supplemental information that 

you may be interested in regarding last year's sentinel event. In addition to the risk 

management initiatives undertaken as result of the initial root cause analysis, ongoing 

review by the Transfusion Committee has resulted in other comprehensive assessment 

and process changes to further minimize clinical risks to patients. 

9 
165 

(I) There is a two-person veri fica lion of patient identification required at the time that 

any blood specimen is obtained for cross-matching and transfusion as well as prior to the 

transfusion of any blood or blood product. 

(2) We have consulted specialists in the area of transfusion medicine to work wi'th us as 

we continue our aggressive review of all aspects of care in this field such as: ordering; 

distribution and handling; administration; and effectiveness of systems in identifying and 

managing risks. 

(3) As a resuh of a VHA-national initiative, bar coding will be implemented to eliminate 

human errors in transfusion that are associated with inaccurate verification of patient 

identification. 

Question 3: Please indicate how you believe the new Risk Management policy will be 

applied at the local level. What specific changes arc planned for your facility or network 

as a result of this new directive? 

Answer: The new risk management policy should not have any significant impact on the 

operations of the Boston VA Medical Center. It should be noted that the 'new' policy 

represents the updating of preexisting policy to reflect systems changes or modifications 

rather than the development of policy that was not previously in existence. The VA has 

had such guidelines and directives in place since its inception. Tbe most significant 

change in the policy is the integration of multiple aspects of risk management into one 

document rather than separate policies. We agree with this concept and functionally have 

operated in this manner for quite some time. We believe that quality cannot be 

adequately assured without integrating the ongoing assessment and management of risk 

into the day-to-day operations of a health care organization. 

To demonstrate commilmentto a proactive versus reactive approach to risk management. 

VHA has integrated the identification of risks and system redesign into its performance 

measurement and improvement processes nationally. There has always been opponunity 

to share lessons learned throughout our system. The process will be expanded to become 

more comprehensive. inclusive, and formally reponed as a result of this new performance 

improvement initiative. 

The systems described above are merely a few examples of how we integrate risk 

assessment and management into the day-to-day operations of the Boston V A Medical 

Center. Similar examples of systems assessment and redesign can be found in all 

services and at all levels of the organization. We routinely assess the quality, 

appropriateness and timeliness of the services we provide so that we can take measures to 

minimize patient injury. Our proactive approach to risk assessment and management was 

acknowledged during our recent JCAHO survey. The internal review and evaluation of 

the effectiveness of systems continues to be ongoing. 

10 
166 

POST-HEARING QUESTIONS 

CONCERNING THE OCTOBER 8, 1997 

HEARING ON VHA'S RISK MANAGEMENT 

POLICY AND PERFORMANCE 

FOR T.C. DOHERTY 

DIRECTOR, VA MEDICAL CENTER, MIAMI, FL 

DEPARTMENT OF VETERANS AFFAIRS 

FROM THE HONORABLE LANE EVANS 

RANKING DEMOCRATIC MEMBER 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTA T1VES 

Question 1: The case you presented today is greatly disturbing to me, not only because 

of the tragic event that occurred due to clinical mismanagement, but because of the 

obvious cultural problems within your organization that must have existed to allow the 

attempted cover-up and failures to report to higber management levels to occur. Has 

your facility gone througb any type of cultural audit to determine what the source of these 

problems is? 

Answer: Without question, the death of patient John Martin while receiving dialysis 

treatment at the Miami V A Medical Center was tragic, especially in view of the fact that 

the caregivers had several opportunities to initiate a medical response after they realized 

their mistake, The tragedy was compounded by the fact that the caregivers elected to 

cover up the mistake, In your inquiry, you mentioned "obvious cultural problems· and 

asked if we had done a cultural audit to determine the source of these problems, In 

response, I have to respectfully disagree that there are obvious cultural problems 

throughout the Miami V AMC. I readily agree that there were cultural issues within the 

Dialysis Unit. These issues were identified during the Root Cause Analysis (RCA) that 

we conducted following the incident. From the RCA, it was quite clear that the cultural 

issues arose within the Dialysis Unit because the unit had, over time, become somewhat 

isolated, functioning in a relatively independent fashion, As you are aware from the RCA, 

this is no longer the case, in that we have a brand new unit, an almost entirely new slaff, 

and a Dialysis Unit environment where communication and team work are fostered and 

praised. 

In answer to your question regarding cultural audit, we have not conducted anything that 

we termed as an organization-wide cultural audit, but indeed we have conducted multiple 

reviews and slaCf surveys in order to ensure that we continually know and undersland the 

opinions, thoughts, and ideas of our slaff; and to ensure that we fully undcrsland our 

organizational environment and culture. From our careful analysis of these reviews and 

surveys, we do not believe the culture within the organization is one that fosters coverups and failures in reporting to higher authority. The Miami V AMC is a very complex 

and culturally diverse Medical Center where all minority groups are recognized and 

valued for their contributions. Tbese groups have worked together, learned together and 

supported each other through a number of significant events. Here again, there is not any 

evidence to suggest cultural differences played a role in this tragic event nor is there 

evidence that cultural diversity lead to cover-ups or failures to report to higher 

authorities. 

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 

conducted a Survey for Cause at our Medical Center in May of this year because of the 

Dialysis incident. The JCAHO surveyor reviewed our RCA and did his own assessment 

of the issues surrounding the event. As was reflected in the JCAHO report we received 

after the survey, the surveyor also recognized culture issues within the Dialysis Unit and 

our Medical Center received recommendations from the JCAHO, accordingly. The 

recommendations affirmed our opinion that this was an issue of cultural separateness on 

the part of one specific unit within our organization, and in no way was indicative of an 

organization-wide cultural problem. We had a second follow-up survey conducted by tbe 

JCAHO on October 27, 1997. The surveyor did a thorough and complete review and 

II 
167 

concluded that we were in 100% compliance with applicable JCAHO standards, that we 

had met all of the recommendations of the JCAHO, and had no further recommendations 

for the organization. 

Question 2: 1 fear that something must first go horribly wrong before V A assesses how 

to redesign systems to improve patient safety. Has your facility undertaken any other re 

engineering studies since the root cause analysis of the event in your dialysis unit took 

place? 

Answer: Rendering quality health care and ensuring patient safety are our top priorities. 

Nothing has to go horribly wrong before we reassess our systems and processes. 

Continuous assessment is on going in everything we do. Strong evidence of this is the 

fact that several hundred thousand procedures are ordered and completed annually and 

few, if any, have had outcomes similar to the one observed in the John Martin case. 

As stated previously, we have conducted multiple reviews and staff surveys. Many of 

them have been conducted to determine what is good and bad about our facility. From 

the 1,000+ responses received, there was no evidence of any disregard for patient safety. 

Nor was there any evidence of fear of reprisal for reporting out-of-line situations. In a 

recent "One V A" Employee Survey conducted by the former Secretary of the Department 

of Veterans Affairs, the Miami V AMC received an extremely high score by employees 

for faith and confidence in top,management for trying to implement quality 

improvements within the Medical Center. The effort to improve does not stop, even with 

the level of confidence expressed in these kinds of responses. 

You asked if we have undertaken any other re-engineering studies since the root cause 

analysis of the event in our Dialysis Unit took place. The answer is "Yes." While the 

Dialysis Unit was the recipient of intense team building exercises and numerous reengineering efforts, the same type of focus is also underway or being planned for the rest 

of the Medical Center. A consultant has been hired to do an assessment of our 

organization's readiness to change. Information gained from this consultant will help us 

to more clearly understand what our barriers to re-engineering are. We are currently 

planning intense customer service training for our staff that will help guide us towards 

enhanced customer relations and help us to become an even more customer-focused 

organization. Recently, we began a major re-engineering effort related to the way we 

assess employee competency. D07.cns of key supervisors and managers participated in a 

two-day seminar conducted by outside consultant, on the subject of employee 

competency. As a result of this seminar, we will be totally changing our employee 

competency assessment process and will be establishing organization-wide competencies 

that every employee must possess in order to satisfactorily perform within the Miami 

V AMC. We are also reorganizing our employee training and development program in 

order to make it more responsive to Medical Center goals and objectives. Funds will he 

spent on programs that have the greatest potential for organizational impact involving the 

largest number of employees. A new multidisciplinary Education Council is being 

selected to establish operational guidance for the education and training process. All of 

these fe-engineering efforts can only positively support our initiatives to become an 

organization on the cutting edge, relative to systems and processes that are geared toward 

providing quality healthcare and patient safety. 

Question 3: How are you taking steps to communicate your commitment to risk 

management to your staff and what if any steps are you taking to encourage staff to 

report? 

Answer: A number of effOrl' have been initiated or are underway to improve 

communications among the staff and leadership, including town-hall meetings, enhanced 

E-mail access, weekly newsletters, etc. Additionally, management is making a 

comprehensive effort to communicate its goals and objectives and is making effective usc 

of multidisciplinary group exercises to address process improvement problems. I reemphasize that without the direct employee input we already receive about problem or 

process areas of concern, we would not be able to effectively identify all of the areas that 

need focused attention. A majority of our employees recognize their role in reporting 

problems andlor areas of concern because they realize that this is the only way to 

12 
168 

effeclively iniliale change and 10 woll< as a team. MOSI employees readily understand and 

acknowledge thaI no one has losltheir job althe Miami V AMC because they reponed an 

oUI-of-line silualion. 

I will continue 10 utilize the multidisciplinary woll<groups 10 develop effective solutions 

10 identify problem areas. Our Qualily Leadership Council will continue to be the main 

body for organizational inpul and development of process improvements. Through our 

extensive communications network, I will continue 10 encourage input from all 

employees, patients and families on how we can make our organization better, more 

effective, and more responsive to our customers. Through our Quality Management and 

Performance Improvement program, I will continue to implement the components of the 

VA. VISN and V AMC Miami Risk Management poliCies and procedures. Further, I will 

continue to encourage use of the Medical Center Risk Management Hotline which has 

been established to foster easy, timely, non-threatening reporting of all adverse incidents 

occurring within the organization. 

13 
169 

POST-HEARING QUESTIONS 

CONCERNING THE OCTOBER 8, 1997 

HEARING ON VHA'S RISK MANAGEMENT 

POLICY AND PERFORMANCE 

FOR BILLY M. V ALENTlNE 

DIRECTOR, VA MEDICAL CENTER, MUSKOGEE, OK 

DEPARTMENT OF VETERANS AFFAIRS 

FROM THE HONORABLE LANE EVANS 

RANKING DEMOCRATIC MEMBER 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

Question 1: I fear something must first go horribly wrong before VA assesses how to 

redesign systems to improve patient safety. Has your facility undertaken any other reengineering studies since your root cause analysis of the events that led to your patient 

being transfused with the wrong blood type? 

Answer: Your question refers to a patient being transfused with the wrong blood type. 

This did not occur at the Muskogee V AMC. However. regarding our incident of a patient 

death at a construction site we have continued to implement and monitor activities based 

on findings from our root cause analysis. Our Facility Safety Manager meets weekly and 

as needed with the contractors for the Replacement Bed Tower to ensure that a safe 

environment in and around the consuuction site is maintained. 

Question 2: Have you assessed any other opportunities for system re-engineering since 

you implemented the new policies responding to the Board of Investigations and the 

Medical Inspector? 

Answer: Assessment and reassessment for system fe-engineering is a continuous effort 

at the Muskogee V A Medical Center. This is accomplished through patient and staff 

education, drills, and critiquing; however, no additional needs have been identified, 

although letters to patients, visitors and employees visiting the medical center have been 

issued regarding dangers of construction. We have implemented the new national "Risk 

Management" policy. 

Question 3: Do you believe that your organization would have either taken proactive 

sleps to prevent this accident or responded any differently had V A had its new risk 

management plan in place in the wake of the incident you just shared with the 

Subcommittee? Please discuss your response. 

Answer: Any further restriction of mentally competent, physically mobile patients 

would infringe on the patients' rights. This incident did not occur as a result of risklilking behavior by any employee. While it may have changed the outcome in our 

particular incident, implementation of the new policy, with a Lessons Learned Intranet 

Database, would have certainly implemented system-wide communication to facilitate 

systems redesign where needed. Had this incident occurred at another facility, and those 

experiences shared, we may have been prompted to conduct more frequent sweeps of the 

construction area to include specific issues addressed in others experiences. For example 

this patient entered the construction site by taking apart a barrier fence. Sharing this 

information with other sites engaged in construction, and with Headquarters facilities 

staff who arc responsible for ensuring construction documents contain appropriate safety 

precautions, will hopefblly prompt them to more closely scrutinize barrier fences. 

14 
FY 

88 

89 

90 

91 

92 

93 

94 

95 

96 

97 

TOTAL 

FY FILED 

88 350 

89 272 

90 248 

91 239 

92 228 

93 219 

94 155 

95 222 

96 185 

97 211 

TOTAL 2,329 

170 

Attachment to Question #1 frol"! Han. J"me Evnns co Dr. Kizer 

VA MEDICAL MALPRACTICE EXPERIENCE 

FISCAL YEARS 1988 THRU 1997 

ADMINISTRATIVE CLAIMS 

Claims Claims Amt. Paid in 

Filed Settled Claims Settled 

844 206 $ 9,304,783 

692 182 $ 7,726,483 

676 168 $ 9,854,744 

672 152 $ 9,868,960 

749 183 $ 13,284,344 

801 188 $ 16,640,350 

978 257 $ 19,640,022 

1,084 252 $ 18,820,625 

1,039 203 $ 20,492,247 

1,117 258 $ 21,129,995 

8,652 2,049 $146,762,553 

LITIGATION 

Jgt. DISMISSAL U.S. 

Jgt. 

PLAINTIFF SETTLEMENTS/AMT. 

77 34 15/$ 3,348,274 150/$ 16,514,057 

80 26 6/$ 2,005,650 169/$ 16,907,393 

75 17 6/$ 1,872,045 179/$ 20,090,593 

75 39 17/$ 6,631,498 130/$ 20,916,550 

61 26 18/$ 9,089,489 141/$ 18,427,452 

61 17 14/$ 3,722,467 114/$ 21,070,888 

53 22 12/$ 3,596,292 127/$ 30,628,483 

56 34 14/$ 7,040,024 107/$ 22,227,467 

74 38 14/$ 5,125,155 127/$ 27,830,873 

58 20 11/$13,834,638 121/$ 27,062,891 

670 273 127/$56,265,532 1,365/$221,676,647 
171 

AMOUNT PAID IN VA MEDICAL MALPRACTICE CASES 

FISCAL YEARS 1983 thru 1997 

:ADMINIS I RA liVE: :LlIIGA liON 

FY :SETTlEMENTS :SETTlEMENTS: :JUDGMENTS: :TOTAL: 

83 $ 4,482,520 $ 9,195,011 $ 2,374,656 $ 16,052,187 

84 $ 5,692,487 $ 8,059,466 $ 4,229,897 $ 17,981,850 

85 $ 14,464,433 $ 13,055,818 $ 7,484,353 $ 35,004,604 

86 $ 10,361,648 $ 17,454,963 $ 5,140,419 $ 32,957,030 

87 $ 11,392,261 $ 17,752,838 $ 5,241,132 $ 34,386,231 

88 $ 9,304,783 $ 16,514,057 $ 3,348,274 $29,167,114 

89 $ 7,726,483 $ 16,907,393 $ 2,005,650 $ 26,639,526 

90 $ 9,854,744 $ 20,090,593 $ 1,872,045 $ 31,817,382 

91 $ 9,868,960 $ 20,916,550 $ 6,631,498 $ 37,417,008 

92 $ 13,284,344 $ 18,427,452 $ 9,089,489 $ 40,801,285 

93 $ 16,640,350 $ 21,070,888 $ 3,722,467 $ 41,433,705 

94 $ 19,640,022 $ 30,628,483 $ 3,596,292 $ 53,864,797 

95 $ 18,820,625 $ 22,227,467 $ 7,040,024 $ 48,088,116 

96 $ 20,492,247 $ 27,830,873 $ 5,125,155 $ 53,448,275 

97 $ 21,129,995 $ 27,062,891 $13,834,638 $ 62,027,524 

TOTAL $193,155,902 $287,194,743 $80,735,989 $561,086,634 
172 

VA MEDICAL MALPRACTICE LITIGATION 

FISCAL YEAR 1997 

Cases Closed 

Closed With Payout 

Settled 

Judgment for Plaintiff 

Closed Without Payout 

Dismissed 

Judgment for U.S. 

Cases Tried 

(To Summary Judgment or Beyond) 

Judgment/U .S. as % of trials 

Judgment/Plaintiff as % of trials 

Amount Paid in cases Settled 

Average Settlement 

Amount Paid in Judgment/Plaintiff 

Average Judgment 

Total Amount Paid in Litigation 

Average Award 

210 

132 (63%) 

121 (58%) 

11 ( 5%) 

78 (37%) 

58 (27%) 

20 (10%) 

31 (15%) 

65% 

35% 

$27,062,891 

$ 223,660 

$13,834,638 

$ 1,257,694 

$40,897,529 

$ 309,829 
173 

VA MEDICAL MALPRACTICE CLAIMS 

FISCAL YEAR 1997 

Claims Closed 

Settled 

Denied 

Denied without suit following 

Cases Finally Closed Administratively 

Amount Paid on Claims Settled 

Average Settlement 

758 

258 (34%) 

500 (66%) 

289 (58%) 

539 (72%) 

$21,129,995 

$ 81,899 
174 

Attachment to Ouestion 7 

from Hon. Lane Evans to Dr. Kizer 

Frequency of Adverse Events Identified for Review at 

VA Medical Facilities 

Adverse events are unexpected and undesirable events that mayor may not lead 

to negative consequences. The V A requires its clinical and non-clinical staff to report all 

such adverse events. The VA reviews them to identify possible errors or design defects 

in care delivery systems in order to improve patient care. Table I shows how frequently 

14 categories of adverse events occurred at VA medical facilities from FY 1994 to FY 

1997. The definitions of the 14 categories are in Appendix 1. 

Adverse events requiring review that led to death were separately analyzed. For 

each year from FY 1994 through FY 1997, we determined the proportion ofacute care 

inpatients treated within V A hospitals who died as a result of any of these adverse events 

requiring review. 

FY 1994 - 2.3 per 1,000 inpatients treated 

FY 1995 - 1.8 per 1,000 inpatients treated 

FY 1996 - 1.4 per 1,000 inpatients treated 

FY 1997 - 1.2 per 1,000 inpatients treated 

The most comparable data available from non-VA hospitals come from the 

widely respected Harvard Medical Practice Studyl, which examined the care received by 

30,000 randomly selected acute care patients hospitalized in New York State in 1984. In 

this study 5.0 per 1,000 inpatients treated experienced an adverse event that caused their 

death. A second relevant study, the California Medical Insurance Feasibility Studl, 

assessed the care given to 20,000 California inpatients in 1974. The authors reported that 

4.5 of every 1,000 patients studied died as a result of their health care management. 

References 

I. Leape LL, et al. Incidence of adverse events and negligence in hospitalized patients. 

Results of the Harvard Medical Practice Study 1. New England Journal of Medicine. 

324:370-376, 1991. 

2. California Medical Association. Report of the Medical Insurance Feasibility Study. San 

Francisco: California Medical Association, 1977. 
175 

Table 1 

Number of Adverse Events Requiring Review in VHA 

FY 1994 . FY 1997 

FY94 FY95 FY96 FY97 

Rate Per Rate Rate Rate 

1,000 Per Per Per 

1,000 1,000 1,000 

Patients Patients Patients Patients 

Category* # Treated Treated # Treated # Treated 

# 

No informed consent 94 0.0334 36 0.0125 46 0.0157 41 0.0135 

Medication errors 120 0.0427 104 0.0360 101 0.0344 101 0.0332 

Wandering patient 82 0.0292 112 0.0388 99 0.0337 18 0.0059 

Transfusion errors 5 0.0018 6 0.0021 3 0.0010 1 0.0003 

Falls 1026 0.3650 1003 0.3470 883 0.3006 663 0.2178 

Patients involved in 4 0.0014 12 0.0042 16 0.0054 7 0.0023 

fires 

Patient abuse 998 0.3550 762 0.2637 564 0.1920 395 0.1298 

Assaults 50 0.0178 55 0.0190 37 0.0126 39 0.0128 

Sexual assault 42 0.0149 41 0.0142 51 0.0174 64 0.0210 

Suicide attempts 848 0.3017 837 0.2896 764 0.2601 562 0.1847 

Suicide 281 0.1000 245 0.0848 220 0.0749 168 0.0552 

Homicide 3 0.0011 11 0.0038 15 0.0051 13 0.0043 

Deaths requiring review 897 0.3191 674 0.2332 417 0.1420 274 0.0900 

Miscellaneous injury 538 0.1914 499 0.1727 394 0.1342 299 0.0982 

TOTALS 4988 1.7745 4397 1.5214 3610 1.2291 2645 0.8691 

'See Appendix 1 for definitions of 14 categories. 

"Rate of adverse event. where 1.0 would be 1 patient per 1,000 patients treated and 0.10 

would be 1/10th of 1 patient per 1,000 patients treated. Total number of patients treated for FY 

1994 - FY 1997 FY 1994 - 2,810,975; FY 1995 - 2,890,157; FY 1996 - 2,937,000; FY 1997-

3,043,449 
176 

Appendix 1 

Definitions of 14 Adverse Events 

1. No Informed Consent: 

Informed consent is not obtained for any invasive procedures or for any patient 

participating in a research protocol. 

2. Medication Errors: 

An administration or dispensing of medication that deviates from the phYsician's order as 

written in the patient's medical record or as written on an outpatient prescription foml or 

which deviates from standard medical center policies and procedures for administering 

and dispensing medications and results in a significant injury or death. Prescribing errors 

that result in a significant injury* or death are also included. 

3. Wandering Patient: 

A search for a patient who disappears from the patient care area for any length of time. 

even if found or the patient returns on his/her own, if the patient has a court-appointed 

legal guardian, is considered a danger to self or others, is legally coIl1mi\\ed. ll[ lacks 

cognitive ability to make decisions. 

4. Transfusion Errors: 

Blood administered to the wrong patient. administered when not ordered. administered 

using the wrong product, incorrectly administered, or an error occurred in the type/cross 

match process. 

5. Falls: 

All falls whether observed or not that result in a significant injury or death. 

Ii. Patients Involved in Fires: 

Includes patients who set a fire, are hurned, experience smoke inhalation. or arc 

otherwise involved in a fire. 

7. Patient Abuse: 

Acts against patients. which involvt: physical, psychological, sexual or wrhal :lhusc. 

Employce "intent" to ahuse is not a rCljuirell1cnl. 

4 
177 

8. Assaults: 

Unwanted physical contact that results in a significant injury. 

9. Sexual Assault: 

Sexual contact without consent with or without penetration and regardless of gender. 

10. Suicide Attempts: 

Self-destructive act requiring inpatient medical or surgical care or behavior which carries 

a high risk for severe injury or death by patients currently receiving inpatient or 

outpatient care or who had a V A clinical encounter or visit within 30 calendar days. 

11. Suicide: 

Taking of one's own life by patients currently receiving inpatient or outpatient care or 

who had a V A clinical encounter or visit within 30 calendar days. 

12. Homicide: 

The death of a patient or staff member intentionally caused by a patient or the death of a 

patient intentionally caused by another individual. 

13. Deaths Requiring Review: 

Deaths that occur in the operating room, in the recovery room, during induction of 

anesthesia (including in procedure rooms), within 48 hours of surgery, within 24 hours of 

a procedure, or during use of a medical device; also, deaths due to equipment 

malfunction, deaths reportable to and accepted by the medical examiner, and deaths of 

patients who are on the medical center grounds but not necessarily being treated at the 

time. 

14. Miscellaneous Injury: 

Signit1cant injury or death to a patient resulting from an adverse event not specifically 

addressed elsewhere is included in this category. 

* A significant injury is an injury that requires medical or surgical intervention or 

increased hospital stay, or is disabling or disfiguring so that the patient will have any 

degree of permanently lessened function or quality of life. 

5 
178 

HARVARD SCHOOL OF PUBLIC HEALHI 

Dcpanment of Health Policy and Management 

lucian l. Leape. M.D. 

Hon. Lane Evans 

U.S. House of Representatives 

Committee on Veterans' Affairs 

335 Cannon House Office Building 

Washington. DC 20515 

Dear Rep. Evans: 

November 25. 1997 

Thank you for the opportunity to answer your questions about improving safety in the 

Veterans' Health Administration. Here are my replies. If there are futther questions. do not 

hesitate to get in touch with me. I appreciate your efforts on behalf of all of us to make 

health care safer in the VA. and. by example. to encourage the private sector to do likewise. 

Lucian L. Leape. MD 

677 Huntington Avenue Boston, Massachusens 02115 617432-2008 Fax: 617 432-4494 
179 

Post-Hearing Questions for Dr. Lucian Leape 

J. Based on your knowledge of the VA and other health care systems. are VA patients any 

more likely than patients of other systems to experience an adverse event that results in injury 

or death? 

I. I never practiced in the V A health system so my knowledge of patient care in the V A 

is severely limited. In addition. I am a pediatric surgeon. and I have been out of 

clinical practice for 11 years, further limiting my knowledge. However, my general 

understanding is that V A patients in general are older and tend to have more severe 

disease than the average patient in non-VA acute care hospitals. If that is true, then 

they may well be more likely than other patients to experience adverse events since 

our studies in the private sector have shown that adverse events are more common in 

both the elderly and those with complicated illnesses. 

2. Your testimony describes an approach to risk management which centers on re-designing 

systems to control for human fallibility. Can you identify the types of system breakdowns 

health care facilities are most likely to experience that result in adverse outcomes? Does VS 

have different problems than other providers? 

2. We don't know the answer to this question because the nature and extent of systems 

failures in health care has not been examined extensively. Most studies have 

concentrated on the medication system, in which systems failures have been 

demonstrated at every stage, but most extensively in the physician prescribing stage 

and in the nurse medication administration stage. Other areas that are known to have 

higher than average adverse event rates that probably are due to systems failures are 

emergency rooms, intensive care units, and operating rooms. I do not know if V A 

has different problems than other providers. 

3. VA has a series of general approaches to system redesign listed in Appendix A of its Risk 

Management Handbook. These approaches. such as "standardize", "reduce reliance on 

memory". "u.fe protocols" .fOund like pretty practical advice. Are vouJamiliar with the 

approaches in Appendix A and if so do you think they are generally sound? If these general 

approaches based on medical literature are sound and useful in preventing injury or death. 

why do you believe VHA would be reluctant to recommend them to its facilities? 

3. The approaches described in Appendix A of the VA Risk Management Handbook are 

indeed sound - they represent the application of human factors principles that have 

been proven effective in other industries, and, to a limited extent, in health care. I 

have not heard that VHA is reluctant to recommend them and if it is I do not know 

why. 
180 

4. What can VA do to encourage its clinicians to repon adverse aU/comes quickly and 

honestly? 

4. Quit punishing them for reporting. While I recognize that efforts are being made to 

develop a non-punitive environment within the V A, the need to punish people when 

they make mistakes is very deeply ingrained in all of us. That is, the concept that an 

error - particularly an egregious one, such as removal of the wrong organ - results 

from systems failures is difficult for most people to accept. Not only is it counterintuitive, it offends our sense of justice somehow. Certainly, we think, SOMEONE 

should pay. So, even in a system that tries to be non-punitive, a fair amount of 

punishment will seep through - sending a loud message to all that it is better not to 

report events that arejl't obvious. It is not a matter of dishonesty, it is a matter of 

self-preservation. A!\d it is universal. 

A critical ingredient in changing this culture of blame is developing the recognition 

that the cause of an error is almost always multifactorial. Therefore, understanding 

the "root cause" requires extensive investigation and analysis. An error is never just 

one person's fault. Creating a safe environment requires attention to all aspects -

education and training, process design, team training, working conditions, leadership, 

etc. - that are known to induce individuals to make errors. Management has 

responsibility to stimulate and require all members of the health care team to examine 

these issues and create safer systems. 

Until the culture is changed so that everyone feels it is safe 10 report and discuss 

errors, attempts to monitor errors and adverse events will always fail. A wise 

alternative that would probably improve patient safety more would be to monitor the 

use of safe practices. That is, we should insure that known safety measures are in 

place and operative (see below). 

5. Are there any "quick fixes" to improve patient safety within VA's health care system or 

other health care system you study? What are the easiest types of systems to fix? 

5. Yes. The major systems changes that have the greatest potential to rapidly and 

substantially reduce errors in health care are in information processing. Specifically, 

computerized physician order entry has the potential to cut the rate of medication 

errors in half. Similarly, the computerized medical record. which permits timely and 

accurate access to all pertinent patient information by all parties who need to know, 

has great potential to reduce all kinds of errors in patient care. 

"Tried and true" systems changes from the past that if not already in place should be 

implemented promptly include: unit dosing, 24-hour availability of the pharmacist, 

central IV-admixture, protocols for ER management of trauma, myocardial infarction, 

etc., protocols and preprinted orders for chemotherapy and other hazardous drugs 

such as insulin. removal of concentrated potassium chloride from floor stock in rcus 

and regular units, weight-based heparin dosing, and anticoagulation services run by 

nurses or pharmacists. 
181 

Experience in other industries suggest other changes that would improve patient 

safety, such as prohibition of double shifts or 12-hour shifts, standardization of 

processes, simplification of processes, use of checklists, etc. 

We don't know which are the easiest types of systems to fix. It is undoubtedly easier 

to change processes (such as various components of the medication system) than to reengineer a whole system (although the latter is urgently needed for the medication 

system). And it is probably easier to change processes than traditions (such as long 

hours and double shifts), or practices (such as not functioning in teams). However, if 

one is serious about safety, all of these should be pursued simultaneously. 

I commend you for your attention and concern about safety in the VA. We need these kinds 

of efforts throughout our health care system, but why not start here? Good luck! 

Lucian L. Leape, MD 

November 25, 1997 
The Honorable lane Evans 

Ranking Minority Member 

Committee on Veterans' Affaire 

House of Representatives 

Washington, DC 205155 

Dear Congressman Evans: 

182 

':;~:' 

I am please to respond to your October 30, 1997 letter requesting answers to the 

questions you asked in reference to the Subcommittee on Health's hearing on 

October 8,1997. I have enclosed my response. 

Thank you for your interest in the Department of Veterans Affairs. 

Sincerely 

JOHN H. MATHER, M.D. 

Enclosure 
183 

Post-Hearing Questions for Dr. John H. Mather 

Assistant Inspector General for Healthcare Inspections (54), 

Office of the Inspector General 

Department of Veterans Affairs 

1. In your statement you indicete thet there may have been somewhet clearer reporting 

lines when the VA health care system was organized under the four Regions. Do 

you want to elaborate on this statement and indicete where VHA, under its current 

organizational structure, could take steps to ensure clear lines of communication in 

the event of an adverse outcome? 

Answer: 

The guidance for the four Regions and the twenty-two VISNs that have replaced them, 

in regard to VHA's Risk Management (RM) Policy, have been clear and explicit. The 

exception was the interim Risk Management Directive VHA Directive 97-029 that was 

issued June 6, 1997 and replaced just over three months later with the present Risk 

Management Directive, VHA Directive 1051, September 25,1997. This interim RM 

Directive was a most unfortunate issuance since it gave authority and responsibility to 

the VISNs with very little guidance. The VISNs were expected to develop and issue 

VtSN-wide guidance, which had the great potential for twenty-two different RM 

programs. If this RM Directive had not been changed it would have been very diffiwH, if 

not impossible, to have any consistency in the data that would be collected, monitored 

and tracked, analyzed for trends, and system-wide corrective actions taken. The 

present RM Directive should provide sufficient guidance. 

In addition, there will need to be a continued emphasis in the VISNs to monitor the 

VAMCs and their investigations of adverse events either as focused reviews or 

Administrative Investigations. The VISNs have an augmented responsibility in these 

matters as compared to the guidance previously followed by the four Regions. This will 

be a particular challenga since tha VISNs are sparsely staffed to cover a large spectrum 

of responsibilities such as fulfillment of Performance Plans that include tha execution 

and allocation of resources [VERA), Annual StrategiC Planning and so forth. 

Ultimately, when an adverse event is identified and current explicit instructions are not 

followed or remain ambiguous, VHA should recognize the problems and issue add~ional 

guidance and education. The Office of HeaHhcare Inspections is committed to 

monitoring the implementation of the present RM Directive and will make further 

recommendations for guidelines wherever deficits in the present RM Directive occur. 

2. You indicate that of the 15 reports you reviewad for this Committee, most VA 

medical centers have taken active steps to identify the cause of sentinel eventsand further that those inclined to report to external organizations, such as the Joint 

Commission on Accreditation of Healthcare Organizations, seem especielly invested 

in investigating the root cause of their problems. Should, in addition to their internal 

reporting requirements, all VA medical centers also be required to report to an 

external quality assurance group? 

Answer: 

The Joint Commission on Accred~ation of Healthcare Organizations (JCAHO) is, in 

broad definition, an external quality assurance group. Its accreditation standards do not 

actually require the reporting of "sentinel" events, but they strongly urge that ~s 

accredited healthcare facilities report such adverse events. The JCAHO does monitor, 

independently of voluntary reports, other sources of information and may selt-iMiate a 

site visit team to investigate. The result may be a curtailing of the healthcare facility'S 

accreditation status. Wherever external quality assurance groups encourage or 

mandate the reporting of sentinel events then, VAMCs should fulfill these requirements. 

These external reviewers may be comprised of other Federal regulatory agencies such 

as the Centers for Disease Control and the Food and Drug Administration. It is unclear 

as to whether there is a master list of external quality assurance groups VHA to which 

sentinel or adverse events need to be reported. 
184 

3. With regard to VHA's Medical Inspector, it is sometimes said that no man can serve 

two masters. Is this the case with the Medical Inspector responding to both you and 

VHA? Are you aware of any plans to change the mission or activities aSSociated 

with that office? Have you spoken with the Secretary or Under Secretary about why 

has there been a delay in fully staffing this office: 

Answer: 

The Medical Inspector reports to the Undersecretary for Health and, by statute, its 

operations are overseen by the Inspector General (IG). The IG has delegated this 

oversight responsibility to the Office of Health Care Inspections (OHI). All OMI 

inspection reports are submitted to OHI in draft and we provide comments as to the 

adequacy of the inspection and the reasonableness of the conclusions and 

recommendations. The Undersecretary for Health has contracted with Abt. Associates 

to conduct a broad-based analysis of the role, functions, and responsibilities of the OMI. 

This contractor should be finishing its work this month and we anticipate conferring with 

tM USH on the results of this outside inquiry by Abt Associates momentarily. Ever since 

we issued our Oversight Report on the OM I, February 16, 1997 [OIG Report No: 5H1-

A28-039] we have sought resolution of the three recommendations. Only one has been 

resolved and this concerned the receipt by the OMI of all VIWICs' Boards of 

Investigation reports. The other two recommendations relate to the staffing levels of the 

OMI. The USH has chosen to defer making a final response to our recommendations 

until after he has received the Abt Associates report and can clarify the mis~,on for the 

OMI. Even so, a certain amount of influence on the USH has been exerted and the OMI 

is projected to achieve a staffing level equivalent to just under half of what used to be 

considered necessary. This contrasts with the remaining VHA Headquarters 

organization that have lost between 25 and 30 % of their previous staffing levels. 

4. You indicated that a couple of VA facilities presented documentation from their 

Boards of Investigations that did not convey the same level of concern as others 

over sentinel events. How would you handle these responses? 

Answer: 

The expectation is that the current RM Directive will require the VISNs to carefully 

review all Boards of Investigations (BOI) and make a determination as to their 

completeness and sufficiency. Then each will be forwarded to VHA headquarters where 

several offices, including the OMI, will further review the BOI reports. In OHI, if we were 

referred a BOI or had, in the course of an inspection of a veteran's complaint about poor 

quality of medical care received at a VIWIC, an opportunity to review a BOI we would 

conduct a thorough review. The BOI report would be scrutinized for deficient 

investigations of the issue(s) and, if necessary, additional evidence would be collected 

through requesting additional documents, conducting interviews by telephone or on-site. 

Depending on how severe a threat to 'life and limb' the issue was, a more in-depth 

inspection would be conducted and a report filed with the VIWIC and VHA headquarters 

that may include a number of recommendations which need to be implemented. 

5. Does your office have sufficient staff to sustain the IG's mission and your caseload? 

Answer: 

The staffing level designated for the OHI is 25 FTE but due to funding restrictions the 

authorization has had to be limited to 20 full-time staff. OHl's staffing is insufficient to 

maintain a balance in its product lines of program review, hotline inspections and 

Quality Program Assistance reviews as the number of veteran complaints concerning a 

perceived poor quality of care, received at V IWICs, increases. These complaints, which 

are frequently received from Congressional and other sources, such as VHA itself or the 

Veterans Service Organizations, are becoming more and more complex due to 

companion is~ues such as personnel or possible fraUdulent activities. The affect of this 

increase in number and complexity of holline inspection activity is to restrain OHl's 

ability to complete its other product lines in a timely manner. The deficient OHI staffing 

level has been recognized and the Department has made representation to the Office of 

Management and Budget to increase the assigned FTE in the President's Fiscal Year 

1999 budget request. 

The Statute requires the VA's OIG to maintain a floor of 417 FTE, but OMB has 

submitted a legislative initiative to Congress requesting abolition of this FTE floor. 

Current FTEE levels are Significantly below the statutory floor, creating a situation 

where the OIG's ability to cover VA programs is vulnerable. 
185 

6. The IG's SlraIegic Plan indicates thel your office, woI1dng with VHA. intends to 

conduct a review of VHA's Medical Inspector and Quality Management (QM) 

activities. Has this review begun? C ... you share any preliminary findings? 

Answer: 

The OIG statute provides thet all of VA's programs are subject to review. Public Laws 

99-166 and 100-322 require the OIG to give particular emphasis in its work to 

overseeing the OMI and VHA's quality Assurance adivities. Our ongoing review of the 

OMI is discussed in the answer to Question 3. In addition to OHl's regular ongoing 

review of VHA's quality assurance activities we have initiated two reviews. 

One initiative is at the request of the Senate Veterans Affairs Committee to conduct a 

complete, detailed evaluation of VHA's quality assurance program. We are assessing 

the changes in the quality assurence program over the last five years with regard to its 

scope, administration and staffing at the VNAC, VISN and haadquarters levels. This 

program review will be completed very earty on in 1998. 

The second initiative is the development of a Quality Program Assistance (QPA) review 

program, which is designed to assess the ability of a V NAC to provide high quality of 

care to the veterans it serves. This initiative is in its final phase of piloting and it is 

anticipated that upon completion of an evelualion of its effectiveness as a mechanism 

for fulfilling our oversight function, the QPA program will go operational early in 1998. 

7. Do you believe thet VHA's guidance to the field on risk management policy is 

sound? Are there improvements you might recommend? 

Answer: 

The present RM Directive is sound and consistent with contemporary notions of what a 

RM program should be. The real concern has to be whether it will be adequately and 

properly implemented, and whether the VISNs and VHA headquarters will consistently 

and vigorously ensure that the policy is foll~. In the past there have been 

reasonably good RM policies espoused by VHA leadership, which have not been fully 

complied with. The USH has stated that he thought certain aspeds of the RM policy had 

been going on but he found that they had been forgotten or ignored. In perticular, he 

was referrinO to the collection of information on adverse events in VHA headquarters, 

the tracking and trending of these sentinel events, and the issuance to the VISNs and 

VNACs of instructions on systematic changes thai were needed. Now the intent is to 

conduct such an activity through the VHA headquarters RM Oversight committee and to 

issue guidance through various means on "Lessons Learned". Also, the USH has 

aligned the VA with several other organizations to approach the issue of prevanting 

medical errors more broadly, and it is anticipated thet further adions will come from this 

collaboration. 

8. Your office operates a hotline. Please describe any procedures you have in place 

for communicating with the VHA's Centrel Office following a Class I HoUine Call. 

Answer: 

The OIG operates a Hotline and Special Inquiries Office which is the central focal point 

for receipt of complaints and inquiries. OHI works very dosely with this office. There are 

many complaints and inquiries that involve issues related to quality of care received by 

veterans. The less serious of these complaints can be handled through a referral to 

VHA without the involvement of OHI, and an appropriate response to the complainant 

can often be made upon review of the response from VHA Some other complaints 

clearly require OHl's immediate involvement because of a Congressional inquiry or the 

apparent serious nature of the issues involved, such as petient abuse or unusual 

deaths. If VHA's OMI is already aware or even involved in the issue, OHI may assume 

the responsibility for the case to be more evidently assured of an independent inquiry, 

or the OMI will continue the inspaction with dose monitOring from OHI. The coordination 

and cooperation has worked well over the past several years although it does require a 

high level of confidence in the OMl's capebilities, and amount of staff resources in the 

OHI to aggressively condud these inspections in a timely mamer. 

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