[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]


 
                  U.S. DEPARTMENT OF VETERANS AFFAIRS 
                     CREDENTIALING AND PRIVILEGING: 
                         A PATIENT SAFETY ISSUE 

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

                                HEARING

                               before the

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 of the

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

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                            JANUARY 29, 2008

                               __________

                           Serial No. 110-65

                               __________

       Printed for the use of the Committee on Veterans' Affairs

                               ----------
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41-365 PDF                       WASHINGTON : 2008 

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                     COMMITTEE ON VETERANS' AFFAIRS

                    BOB FILNER, California, Chairman

CORRINE BROWN, Florida               STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas                 CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine            JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South     RICHARD H. BAKER, Louisiana
Dakota                               HENRY E. BROWN, Jr., South 
HARRY E. MITCHELL, Arizona           Carolina
JOHN J. HALL, New York               JEFF MILLER, Florida
PHIL HARE, Illinois                  JOHN BOOZMAN, Arkansas
MICHAEL F. DOYLE, Pennsylvania       GINNY BROWN-WAITE, Florida
SHELLEY BERKLEY, Nevada              MICHAEL R. TURNER, Ohio
JOHN T. SALAZAR, Colorado            BRIAN P. BILBRAY, California
CIRO D. RODRIGUEZ, Texas             DOUG LAMBORN, Colorado
JOE DONNELLY, Indiana                GUS M. BILIRAKIS, Florida
JERRY McNERNEY, California           VERN BUCHANAN, Florida
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota

                   Malcom A. Shorter, Staff Director

                                 ______

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                  HARRY E. MITCHELL, Arizona, Chairman

ZACHARY T. SPACE, Ohio               GINNY BROWN-WAITE, Florida, 
TIMOTHY J. WALZ, Minnesota           Ranking
CIRO D. RODRIGUEZ, Texas             CLIFF STEARNS, Florida
                                     BRIAN P. BILBRAY, California

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.














                            C O N T E N T S

                               __________

                            January 29, 2008

                                                                   Page
U.S. Department of Veterans Affairs Credentialing and 
  Privileging: A Patient Safety Issue............................     1

                           OPENING STATEMENTS

Chairman Harry E. Mitchell.......................................     1
    Prepared statement of Chairman Mitchell......................    30
Hon. Ginny Brown-Waite, Ranking Republican Member................     3
    Prepared statement of Congresswoman Brown-Waite..............    31
Hon. Jerry F. Costello...........................................     4
    Prepared statement of Congressman Costello...................    32
Hon. Timothy J. Walz.............................................     5
Hon. Ed Whitfield................................................     6

                               WITNESSES

U.S. Department of Veterans Affairs:
  John D. Daigh, Jr., M.D., CPA, Assistant Inspector General for 
    Healthcare Inspections, Office of Inspector General..........    11
      Prepared statement of Dr. Daigh............................    34
  Gerald M. Cross, M.D., FAAFP, Principal Deputy Under Secretary 
    for Health, Veterans Health Administration...................    20
      Prepared statement of Dr. Cross............................    39

                                 ______

Shank, Katrina, Murray, KY.......................................     7
    Prepared statement of Ms. Shank..............................    32

                   MATERIAL SUBMITTED FOR THE RECORD

Charts:
  Risk Adjusted Mortality as an Indicator of Outcomes: Comparison 
    of the Medicare Advantage Program with the Veterans Health 
    Administration...............................................    43

Pre-Hearing Letter and Post-
    Hearing Questions and Responses for the Record:
  Hon. Steve Buyer, Ranking Member, Committee on Veterans' 
    Affairs, and Hon. Ginny Brown-Waite, Ranking Member, 
    Subcommittee on Oversight and Investigations, Committee on 
    Veterans' Affairs, to Hon. George Opfer, Inspector General, 
    U.S. Department of Veterans Affairs, letter dated September 
    14, 2007, requesting the VA Inspector General to conduct an 
    investigation into the surgical deaths at the Marion, 
    Illinois VA Medical Center...................................    44
  Hon. Harry E. Mitchell, Chairman, and Hon. Ginny Brown-Waite, 
    Ranking Republican Member, Subcommittee on Oversight and 
    Investigations, Committee on Veterans' Affairs, to Hon. James 
    B. Peake, Secretary, U.S. Department of Veterans Affairs, 
    letter dated January 30, 2008, requesting VA supply an 
    itemized schedule of implementation dates in the 17 VA Office 
    of Inspector General's recommendations made in the January 
    28, 2008 report, Healthcare Inspection: Quality of Care 
    Issues, VA Medical Center, Marion, Illinois (Report No. 07-
    03386-65); and VA Response Provided in Appendix A of the 
    Report, dated January 23, 2008, Memorandum and Attachment 
    from Michael J. Kussman, M.D., MS, MACP, VA Under Secretary 
    for Health, U.S. Department of Veterans Affairs..............    44
  Hon. Harry E. Mitchell, Chairman, and Hon. Ginny Brown-Waite, 
    Ranking Member, Subcommittee on Oversight and Investigations, 
    Committee on Veterans' Affairs, to Hon. George Opfer, 
    Inspector General, U.S. Department of Veterans Affairs, 
    letter dated February 28, 2008, and response letter dated 
    April 25, 2008...............................................    51
  Hon. Harry E. Mitchell, Chairman, and Hon. Ginny Brown-Waite, 
    Ranking Member, Subcommittee on Oversight and Investigations, 
    Committee on Veterans' Affairs, to Hon. James B. Peake, 
    Secretary, U.S. Department of Veterans Affairs, letter dated 
    March 3, 2008, and VA responses..............................    55
  Hon. James B. Peake, M.D., Secretary, U.S. Department of 
    Veterans Affairs, to Hon. Bob Filner, Chairman, Committee on 
    Veterans' Affairs, letter dated May 14, 2008, transmitting 
    Administration views for H.R. 4463, the ``Veterans Health 
    Care Quality Improvement Act''...............................    62


                  U.S. DEPARTMENT OF VETERANS AFFAIRS
                     CREDENTIALING AND PRIVILEGING:
                         A PATIENT SAFETY ISSUE

                              ----------                              


                       TUESDAY, JANUARY 29, 2008

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

    The Subcommittee met, pursuant to notice, at 10:09 a.m., in 
Room 340, Cannon House Office Building, Hon. Harry E. Mitchell 
[Chairman of the Subcommittee] presiding.
    Present: Representatives Mitchell, Space, Walz, Brown-
Waite.
    Also Present: Representatives Costello, Whitfield

             OPENING STATEMENT OF CHAIRMAN MITCHELL

    Mr. Mitchell. We are here today to address the fallout from 
events at the Marion, Illinois, Veterans Affairs Medical 
Center.
    I was troubled to find out about a pattern of deaths at 
this U.S. Department of Veterans Affairs (VA) hospital that 
went unaddressed. I am further concerned that the system in 
place to catch the substandard care has no rapid response 
measures.
    According to the VA's Office of the Medical Inspector 
(OMI), from the beginning of 2006 through August of 2007, nine 
patients at Marion died as a result of substandard care. 
Another 34 had postoperative complications resulting from 
substandard care.
    The Marion, Illinois, VA Medical Center serves veterans in 
south Illinois, southwestern Indiana, and northwestern 
Kentucky.
    In August of 2007, the Veterans Health Administration (VHA) 
noticed a disturbing pattern. Patient deaths following surgery 
were more than four times the average.
    The VHA sent an inspection team. They suspended all 
surgeries at the hospital and placed the leadership at the 
hospital, including the Chief of Surgery, on administrative 
leave. The VHA responded quickly when the data became 
available, but that data was more than 6 months old.
    The data from the National Surgical Quality Improvement 
Program known as NSQIP, collects information from several 
hundred thousand surgeries performed at VHA facilities every 
year. Unfortunately, NSQIP reports only become informative an 
average of 5 months after an incident, due to a lag in 
gathering and inputting the data.
    When VHA responded in August of 2007 to the pattern of 
excessive deaths at Marion, they were using data that covered 
October 2006 to March 2007. This is unacceptable.
    The VHA cannot respond to problems in its hospitals if it 
does not know what they are. There must be controls to ensure 
that doctors and other healthcare providers have the required 
credentials and are fully qualified to perform the specific 
medical procedures they undertake. Events at the VA hospital in 
Marion, Illinois, tragically show what happens when these 
essential controls break down.
    The Inspector General (IG) and Office of the Medical 
Inspector found that there is a serious hole in the system. The 
VA does not have a way to identify all jurisdictions where a 
physician has been or is licensed. This is because some States 
do not have an electronic registry or are not willing to share 
records.
    The VHA requires that surgeons must receive clinical 
privileges to perform specific procedures at the hospital. The 
IG and the OMI discovered that this process had been abused at 
Marion. In fact, the privileges were granted at Marion 
regardless of the experience or training.
    Even more disturbing is that privileges were granted at 
Marion for procedures that the hospital did not even have the 
facilities to accommodate, such as radiology access 24 hours a 
day.
    The events at the Marion Hospital demonstrate a failure of 
the VA system to quickly bring important information forward so 
that the VHA can respond with appropriate action. This is a 
real problem.
    Our first witness today is Ms. Katrina Shank. She drove her 
husband, Bob Shank, to Marion for a routine surgery. Bob passed 
away within 24 hours of the procedure due to the substandard 
care at the hospital.
    I believe that if the safeguards had been in place and 
administrators had been properly notified of past incidents, 
Bob's death could have been prevented.
    I want to know why no one outside of Marion was aware of 
the problems until August of 2007 and what VHA is doing to make 
sure that this failure of information flow never happens again.
    Additionally, what is VHA going to do to fix the serious 
quality management issues, credentialing, and privileging that 
has been disclosed by this tragedy?
    I am afraid that once we start looking at this issue 
deeply, we may find what happened at the Marion Hospital is not 
an isolated incident.
    Our veterans served honorably to protect our Nation. We 
have the responsibility to take care of them when they come 
back home.
    And before I recognize the Ranking Member for her remarks, 
I would like to swear in all of our witnesses. I would ask at 
this time that all of our witnesses for all the panels if they 
would please stand and raise their right hand.
    [Witnesses sworn.]
    Thank you.
    Next I ask unanimous consent that Mr. Costello and Mr. 
Shimkus be invited to sit at the dais for the Subcommittee 
hearing today. Hearing no objection, so ordered.
    If Mr. Costello and Mr. Shimkus would join us, please come 
to the dais.
    I would like to now recognize Ms. Brown-Waite for her 
opening remarks.
    [The prepared statement of Chairman Mitchell appears on p. 
30.]

          OPENING STATEMENT OF HON. GINNY BROWN-WAITE

    Ms. Brown-Waite. Thank you, Mr. Chairman, and I thank you 
for yielding.
    When the news came out last year showing a spike in 
surgical deaths at the Marion, Illinois, VA Medical Center, we 
on this Committee were concerned. We wanted to know whether 
this was an isolated incident or more widespread than reported.
    On September 14th, Ranking Member Buyer and I wrote a 
letter asking for an investigation by the Office of the 
Inspector General into the spike in surgical deaths.
    I am asking for unanimous consent to submit a copy of this 
letter for the record.
    [The September 14, 2007, letter to Inspector General George 
Opfer, appears on p. 44.]
    Mr. Mitchell. So ordered.
    Ms. Brown-Waite. Thank you.
    I hope to hear from the Inspector General this morning 
about the results of the investigation.
    On November 6, 2007, our Senate counterparts held a hearing 
on this issue as well. During this hearing, the U.S. Government 
Accountability Office (GAO) testified that in their 2006 review 
of the VA's credentialing requirements, it made four 
recommendations that VA medical facility officials must (1) 
verify that all State medical licenses held by physicians are 
valid; (2) query the Federation of State Medical Boards' 
database to determine whether physicians had disciplinary 
actions taken against any of their licenses, including expired 
licenses; (3) verify information provided by physicians on 
their involvement in medical malpractice claims at the VA or at 
a non-VA facility; and (4) query the National Practitioner Data 
Bank (NPDB) to determine whether a physician was reported to 
this data bank because of involvement in a VA or non-VA paid 
medical malpractice claim, and also display of professional 
incompetence or engaged in professional misconduct.
    I am interested to hear if the VA was following all of 
these recommendations. If they were, I would like to know how a 
physician who lost his license in the State of Massachusetts, 
but still licensed in the State of Illinois, was allowed to 
practice at the VA facility in Marion, Illinois.
    I think it is imperative that we explore the circumstances 
of this situation to prevent similar cases in the future. To do 
this, several questions still need to be answered.
    How current are the national databases available to 
maintain licensing standards and how is information on 
licensing actions disseminated to other States?
    The current NPDB system does not inform the agency of 
actions taken against a license, although I understand that 
they are in the process of developing a prototype to do this. 
The question is, has VA enrolled in this prototype?
    Committee Members have been told repeatedly that the VA has 
one of the best healthcare systems in the Nation. The VA 
healthcare system is one that many other hospitals and 
healthcare systems are trying to emulate.
    However, when the VA maintains credentialing for a 
practitioner whose license has been revoked in another State, 
we must question the quality of care being provided to our 
Nation's veterans.
    Also, it is apparent that the scope of privileging and the 
commensurate appropriateness of staffing support has not been 
afforded the professional due diligence of responsible senior 
management. VA's premier healthcare delivery system is marred 
by some senior managers asleep at the wheel.
    When veterans come to VA hospitals and outpatient clinics, 
they should not have to worry about whether or not their 
physician has a valid license to practice medicine. Veterans 
should not have to worry about whether the State of 
Massachusetts or any other State has revoked the license of a 
doctor practicing in Illinois for quality of care issues.
    Our veterans trust that the VA does its part to ensure 
practitioners in VA medical facilities are the best trained and 
most qualified individuals to care for them. For the VA to do 
anything less is simply unacceptable.
    Thank you, Mr. Chairman, and I look forward to hearing the 
witnesses that we have before us today. I yield back.
    [The prepared statement of Congresswoman Brown-Waite 
appears on p. 31.]
    Mr. Mitchell. Thank you.
    At this time, I would call on Mr. Costello.

          OPENING STATEMENT OF HON. JERRY F. COSTELLO

    Mr. Costello. Mr. Chairman, thank you, and thank you for 
allowing me to participate in this hearing today, and thank you 
for calling the hearing, both yourself and the Ranking Member.
    I would ask unanimous consent, Mr. Chairman, that my 
statement, my full statement be entered into the record.
    Mr. Chairman, as we will hear today from our witnesses, 
both the IG and an internal investigation that was conducted by 
the VA, one is that the IG's report indicates that there are 
three patients who died as a result of substandard care 
administered by medical officials at the Marion facility. And 
as the internal investigation at VHA will reveal is that, as 
the Secretary informed me yesterday, that there are nine deaths 
that occurred as a result of substandard care at the Marion 
facility.
    From my briefing yesterday with some of the witnesses that 
you will hear from today and my conversation with the Secretary 
yesterday, it is clear to me that the VA facility in Marion was 
grossly mismanaged during this period of time. And as you 
noted, the IG report covered a period of one fiscal year and 
the investigation that is being done internally by the VA 
covers a 2-year period. But it is clear that there was gross 
mismanagement on the part of those running the facility at 
Marion.
    I want to say for the record that Marion, Illinois, and the 
facility are in the congressional district that I am privileged 
to represent. I know most, if not all, of the employees who 
work at the facility and that they are good, dedicated, 
hardworking professionals. The mismanagement was on the part of 
the top administrators at the facility, not on the part of the 
nurses and other professional staff.
    It is worth noting, too, that the nine deaths that the 
internal investigation revealed resulted from substandard care, 
that all of these patients were under the care of two specific 
physicians.
    In addition to gross mismanagement, it is very clear that 
there was a lack of oversight on the part of the VHA concerning 
this facility and the practices of these physicians.
    And it is my hope that as a result of this hearing and as a 
result of the investigation by the Inspector General and the 
internal investigation that, one, that we will see prompt 
action on the part of the VA to institute management at the 
facility that will follow procedures, follow practices, and 
implement standards that already exist; two, that we will see 
aggressive oversight by VHA of not only the Marion facility but 
all of the facilities under the jurisdiction of the VHA, and 
also that it is very clear that national policies need to be 
developed and implemented for all of the facilities so what 
happens at the VA facility and what has happened there during 
this period of time does not happen ever again in Marion or any 
other facility.
    Finally, it is my hope, and I expressed this to the 
Secretary yesterday, that the VHA will immediately contact the 
families of the nine patients who died as a result of 
substandard care at this facility, that they will not only 
inform them but assist them in filing claims against the VA and 
against the Federal Government; two, that the VHA releases all 
of the information regarding this investigation to the public.
    Many of my constituents, and I think Mr. Whitfield's 
constituents, Mr. Shimkus, those who are served by this VA 
facility, are wondering is this problem unique to the facility 
in Marion or this is a problem throughout the VHA at every 
facility.
    And so it is my hope that they will release all of the 
information concerning this investigation and then, lastly, 
begin the process to implement policies to make sure that 
checks and balances are being performed and that we get back to 
providing the quality care that the VA has been noted for in 
the past.
    So I again thank you, Mr. Chairman. I thank the Ranking 
Member and all of the Members of the Subcommittee for allowing 
me to participate.
    [The prepared statement of Mr. Costello appears on p. 32.]
    Mr. Mitchell. Thank you.
    Mr. Walz.

           OPENING STATEMENT OF HON. TIMOTHY J. WALZ

    Mr. Walz. Thank you, Mr. Chairman and Ranking Member Brown-
Waite.
    Ms. Shank, I am sincerely sorry for your loss, and I can be 
fairly certain that there is probably any place in the world 
you would rather be than right here and I am sure you would 
rather be there with your husband.
    And we are not here on a witch hunt, but we are sure here 
to understand and recognize that the human tragedy in this 
cannot be overlooked.
    To give you the respect that you and your husband have 
earned, to look you in the eye and to talk about what we are 
going to do to make sure that this never happens again, I 
wished every Member of Congress could be here because I fail to 
ever see a politician who does not support our veterans, and 
then we hear about tragedies like this.
    It is not time for the platitudes. It is not time to say, 
oh, it will be okay or we are sorry, a mistake was made. We 
know we are in the business, and I have often sat here and 
talked to people from the VA. I am a staunch supporter of the 
thousands and thousands of people who work in the VA with the 
sole purpose of caring for our veterans.
    But I am also one of their harshest critics whenever we do 
not get it right. These are people who deserve our highest 
sacrifices ourselves. They deserve the highest and the best 
quality care that they can receive. I have often said it, this 
is a zero sum game, not a single veteran or their family should 
have to sit where you are at and testify what you are about to 
say. It should be our responsibility to make sure that never 
happens.
    And I take that very seriously. I know the Members of this 
Committee take it very seriously. And our goal is to make sure 
that we do not just provide that lip service, that we make 
things right. But I know no matter what we do, none of those 
things will ease the pain of your loss, but I praise you for 
your courage to come here because what you are doing will 
ensure no one else sits where you are at.
    So I thank you for that, and I yield back to the Chairman.
    Mr. Mitchell. Thank you.
    Mr. Space.
    Mr. Space. Thank you, Mr. Chairman.
    I have no statement other than to express my sorrow for 
your loss, and as a Member of this Committee, my commitment to 
make sure that it does not happen anywhere in this country 
again. And thank you for your courage in coming today.
    Mr. Mitchell. I ask unanimous consent that all Members have 
5 legislative days to submit a statement for the record. 
Hearing no objections, so ordered.
    At this time, I would like to recognize Congressman Ed 
Whitfield of Kentucky who is here to introduce his constituent, 
Ms. Katrina Shank.
    Congressman Whitfield.

              OPENING STATEMENT HON. ED WHITFIELD

    Mr. Whitfield. Chairman Mitchell and Ranking Member Brown-
Waite and other Members of the Subcommittee, we thank you so 
much for having this important hearing on VA credentialing and 
patient safety.
    I would also just mention I left a hearing a few minutes 
ago with Congressman Shimkus and he is the Ranking Member on a 
Subcommittee that is issuing subpoenas related to the Food and 
Drug Administration this morning or he would be here. So he 
asked me to convey that message to you and that he appreciates 
this hearing as well.
    I would just say that all of us have certainly been 
shocked, disappointed, and upset about revelations of 
substandard care at the Marion VA Hospital.
    And I have the privilege this morning of introducing a 
constituent of mine, Katrina Shank, from Murray, Kentucky. I 
know it is very difficult for her to be here today.
    And I know that the testimony that she is going to provide 
will assist you as you make decisions about ways that we can 
guarantee good healthcare for our veterans. Our Nation's 
veterans deserve the best and in my mind, that certainly means 
competent, medical care that our Nation can offer.
    I had the opportunity to meet with Ms. Shank yesterday and 
she told me about how her husband, Bob, who served in the 
military had gone to Marion for a routine gallbladder surgery 
and he never left the hospital and died just a day or so later 
from what was clearly substandard care that was given to him at 
the hospital.
    So I want to thank her very much for her courage. Certainly 
all of us offer our sincere condolences, but we do thank her 
for being here today and look forward to her testimony.
    And, once again, I want to thank you all for your efforts 
to nationwide ensure that our veterans have quality and 
competent medical care. Thank you very much.
    Mr. Mitchell. Thank you.
    At this time, I would like to recognize Ms. Shank for 5 
minutes.

         STATEMENT OF KATRINA SHANK, MURRAY, KY (WIDOW)

    Ms. Shank. Mr. Chairman, ladies and gentlemen of this 
Subcommittee, my name is Katrina Marie Shank.
    I am sitting before you today because I am the widow of 
Robert (Bob) Earl Shank III of Murray, Kentucky, who passed 
away August 10, 2007, after a routine laparoscopic gallbladder 
surgery at the Veterans Administration hospital in Marion, 
Illinois.
    Bob was a United States Air Force veteran who served his 
country from July 30, 1975, to July 13, 1977, discharged with 
the service character of honorable.
    I met my husband in July 1997 when he started working at 
the Maytag plant that I was hired into in September 1995. We 
were co-workers and friends for 6\1/2\ years prior to our 
marriage on June 25, 2004.
    Bob was a reliable, hard worker and was promoted to group 
leader in our department, a position he held for several years.
    Upon the closure of the Maytag plant on December 26, 2006, 
we relocated to Murray, Kentucky, on January 27, 2007, to be 
closer to my family and to establish a start to our retirement 
today down near Kentucky Lake.
    Bob was an outdoorsman. He enjoyed hunting, fishing, 
golfing, and four-wheeler riding. We thought that if we were 
going to have to start all over, then we could be somewhere and 
could enjoy retirement together.
    Bob helped raise six children of which only one was his 
own. When I met him, the first older three children were 
already young adults and out on their own. My children were 
still small and he wanted to be the dad, but he did not have to 
be.
    He was a man that took respect very seriously before he 
asked me to marry him. He did not ask my father for my hand in 
marriage. He respected my children enough as individuals that 
he asked each of them for permission to marry me. That says a 
lot about a man's character to want to raise another man's 
children, not once, but twice, when he could have started 
living a life without children still at home.
    He was the type of man that if you needed something that he 
had, without any questions asked, it was yours. He was always 
trying to help the next person out.
    We both wound up back in the VA system after we lost 
private insurance when the Maytag plant closed. Before that, 
since we had the private insurance to pay for our healthcare, 
we opted not to use the facility and the benefits in hopes this 
would help with the overcrowding of the VA, giving the next 
veteran a better chance at receiving the help and care that 
they needed, where that might be the only option many of our 
veterans have for healthcare.
    In turn, I now have reservations and fears of returning to 
the VA hospital for my personal healthcare.
    On June 26, 2007, we traveled to Marion VA for an 
ultrasound of his entire abdomen in which only the upper right 
quadrant was scanned. The technician found the gallbladder and 
did not continue to scan on the rest of the abdomen. The test 
revealed that his gallbladder was full of stones and that 
surgery to remove the gallbladder was the course of action to 
be taken.
    I started my new job on July 26, 2007. And in fear of 
putting my job in jeopardy so soon after hiring in, I was 
unable to attend his first meeting with Dr. Mendez on August 2, 
2007.
    Bob was originally scheduled for surgery in September. But 
before he left the hospital that day, there was a cancelation 
for August 9, 2007. He was asked if he would like to have that 
appointment instead. Naturally, in a desperate attempt to be 
relieved of his pain, he accepted this earlier appointment.
    But I wonder would he still be here today had his surgery 
not been moved up. Chances are he might have even had a 
different surgeon given the investigation that we know now 
would have started prior to the surgery being performed in 
September instead of August.
    With the same fear of losing my job, I almost did not 
accompany Bob to the surgery that day. One of my parents was 
going in my place instead. Thank God above that I found the 
courage and strength to approach my new boss with my situation 
and asked for the time off that I needed for his surgery.
    The first time I met Dr. Mendez was about Bob's surgery 
when he came to me and said something had gone wrong during the 
surgery, that my husband just would not wake up. Maybe he had a 
heart attack. Maybe he had a stroke. I just do not know what 
happened. We are taking him up to ICU where he can be cared 
for. I have another patient waiting on me.
    We left outpatient surgery and went to ICU. We were 
standing in the hallway when they wheeled my husband by. Going 
into ICU as they passed, the nurse was manually bagging him to 
keep him breathing.
    The next time I saw my husband as the doctor pulled me by 
the hand through a crowded room full of nurses and doctors to 
his bedside, he lay there motionless with tubes coming out of 
his body, hooked to IVs and machines, as he was already placed 
on life support.
    Throughout the course of the night, I was approached by Dr. 
Mendez several times to hear him comparing my husband to a car 
that needed routine checkups and blamed my husband for not 
taking care of his body. He also at one point told me that my 
husband had liver damage that we knew nothing about and that 
had caused his problems.
    The autopsy performed on my husband did not reveal any 
liver damage. The doctor was covering his own tracks.
    As my husband lay there with his blood pressure still 
dropping, another doctor had questioned Dr. Mendez about taking 
him back into surgery to find out where the blood was going. 
Dr. Mendez's response was, I have this under control. He waited 
several hours before taking him back into surgery to explore 
where he was losing blood from. Standing in the hallway talking 
to Dr. Mendez, he told my sister and me I have to try 
something. I either let him lay here and die or I kill him on 
the operating table, but I have to try something.
    By the time he took him in, Bob's blood pressure was so low 
his blood was not spurting with his heartbeat. It was just an 
oozing effect making it difficult for Dr. Mendez to determine 
where the blood was coming from.
    I believe had he gone back into surgery sooner when it was 
suggested by the other doctor, my husband would have had a 
better chance for survival.
    The autopsy revealed his bile duct had been cut and he had 
a two centimeter laceration to his liver. The sutures that were 
placed in my husband's body had a knot at one end of the stitch 
and not at the other end. The heart attack and/or stroke the 
doctor blamed my husband's death on was not supported by the 
autopsy either.
    As I left the hospital after my husband passed away, I had 
an overwhelming feeling that there was more to this story. 
Something just did not seem right. The nurses had a look in 
their eyes that they knew something but just could not tell me 
what it was.
    I returned to the hospital on August 16, 2007, to sign 
papers for release of information to obtain a copy of his 
medical record and an autopsy report. To this day, we still do 
not have a complete set of records.
    While I was there, I saw the Chaplain who had sat and 
prayed with me through the night and one of the nurses that 
took care of my husband in ICU, again with that same look on 
their faces and their eyes that told me there was more to my 
husband's story and they just could not tell me.
    Before my children and I left the hospital that day, a 
hospital employee, which I had contact with shortly after Bob's 
passing, pulled me to the side. As he looked around and over 
our shoulders as if to make sure no one could ever overhear, he 
told me you need to hire an attorney, that my husband was Dr. 
Mendez's third patient death recently, one of which the man's 
wife worked at the hospital.
    Dr. Mendez had up and resigned from the hospital Monday 
morning and did not even have the decency to come to the 
hospital to resign. He sent them an e-mail instead. That was 
August 13, 2007, just 3 days after Bob passed away.
    As my mouth and my heart fell to the floor, I was shocked 
and instantly angry. As the pieces of the untold story were now 
falling into place, this seemed to be the coward's way out and 
that he was on the run because he knew he had done something to 
Bob. In my mind, him fleeing was his admission of guilt to what 
happened to my husband.
    As I look back on the day of August 9, 2007, on our trip up 
from Murray, Kentucky, to Marion, Illinois, about a 2-hour 
drive, we did not discuss his operation. We were at ease 
knowing that he was finally going to get the relief from his 
pain that he so desperately needed and had waited for. And we 
did not foresee any problems or complications and assumed he 
would be returning home with me the next day, August 10, 2007.
    However, he passed away that Friday morning instead, but 
finally we were able to bring him home on August 16, 2007, in a 
wooden urn that now sits on top of our entertainment center. A 
picture of him cropped out of our wedding photo is overlooking 
his urn. Alongside are two of his Air Force pictures placed 
underneath two trophy ducks that he had hung on the wall 
himself when we moved into our new apartment to start living 
the rest of our lives together and looking forward to our 
retirement.
    I speak to my husband's ashes and picture every night 
before going to bed. I stand there with tears rolling down my 
face telling him how the day has gone and how much he had 
missed out on. I always end my conversations with I love you 
and I miss you and goodnight, my love, and give him a goodnight 
kiss on the outdoor scenery of the urn where my husband now 
rests in peace.
    No other veteran's family should have to go through the 
heartache and the pain that mine and Bob's families have had to 
endure. So in closing, I ask why my husband's life had to end 
this way? Why was this allowed to happen given Dr. Jose 
Viezaga-Mendez's track record? How did the system fail my 
husband and several other veterans at the hands of this doctor? 
How many other veterans are going to have to lose their lives 
before we as a country can offer them more reliable healthcare?
    I want to thank you for this opportunity to have our voices 
heard and our questions answered. Although my husband did not 
die during battle for our country, I ultimately believe that 
through us, he is still fighting for the safety of his comrades 
in arms and the future healthcare of our American veterans.
    [The prepared statement of Ms. Shank appears on p. 32.]
    Mr. Mitchell. Thank you very much.
    Any questions?
    [No response.]
    Mr. Mitchell. Thank you. We appreciate it.
    At this time, I would like to welcome panel number two to 
the witness table. Dr. John Daigh is the Assistant Inspector 
General for Healthcare Inspections for the VA Office of the 
Inspector General.
    Dr. Daigh's team has recently completed an extensive 
investigation of the quality of care at the Marion VA Medical 
Center, and we look forward to hearing his view on VA's 
credentialing and privileging systems.
    Dr. Daigh, will you please introduce your team.
    Dr. Daigh. Yes, sir. On my right is Dr. Clegg who is a 
statistician in my office. Dr. Andrea Buck, Dr. George Wesley, 
Dr. Jerry Herbers are internists who work in my office.
    Mr. Mitchell. Thank you. You have 5 minutes for your 
testimony.

STATEMENT OF JOHN D. DAIGH, JR, M.D., CPA, ASSISTANT INSPECTOR 
  GENERAL FOR HEALTHCARE INSPECTIONS, OFFICE OF THE INSPECTOR 
 GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY 
 GEORGE WESLEY, M.D., DIRECTOR, MEDICAL ASSESSMENT, OFFICE OF 
    HEALTHCARE INSPECTIONS; JEROME HERBERS, M.D., ASSOCIATE 
DIRECTOR, MEDICAL ASSESSMENT, OFFICE OF HEALTHCARE INSPECTIONS; 
   ANDREA BUCK, M.D., SENIOR PHYSICIAN, OFFICE OF HEALTHCARE 
  INSPECTIONS; LIMIN CLEGG, PH.D., MATHEMATICAL STATISTICIAN, 
OFFICE OF HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR GENERAL, 
              U.S. DEPARTMENT OF VETERANS AFFAIRS

    Dr. Daigh. Thank you, sir. Mr. Chairman, Ranking Member, 
Congressmen, Ms. Shank, I would like to express my sorrow and 
disappointment at the care Ms. Shank so unfortunately described 
this morning.
    We make a conscious daily effort to make a positive 
difference in the quality of medical care that is provided to 
veterans in the hope that events like this can be avoided.
    I am appalled at the medical care that is described in our 
report yesterday. Quality medical care results from careful 
planning and attention to detail.
    The peer review, credentialing, privileging, patient 
adverse event notification policies were among the policies 
that the Marion faculty simply did not comply with.
    The question I was most asked during my briefing yesterday 
was, is there another facility with similar unrecognized 
quality of care problems waiting to be discovered. I answered 
that if I knew of a medical center with similar problems, that 
I would ensure that prompt action was taken.
    I would like to add some context to that response. In all 
of the prior testimony that I have given before this 
Subcommittee, I have unequivocally said that I believe veterans 
are getting excellent quality healthcare. I am less certain of 
that assertion today than I have been in the past.
    In June of this year, we published a report on the 
deficiencies at Martinsburg, West Virginia, which resulted in 
the death of a veteran who was in need of intubation.
    In August of 2007, we published our follow-up report to the 
experience of the surgery service at Salisbury, North Carolina, 
for which I appeared before this Subcommittee some time ago.
    In December of 2007, we reported on significant management 
deficiencies in the ICU in San Antonio.
    And today, we report on the issues at Marion.
    This collection of reports is unusual in my experience and 
in the experience of the men and women who work with me and who 
have been at the IG's Office for many years. And it erodes the 
confidence, my confidence, that veterans are receiving the best 
possible care.
    I am also concerned about the effectiveness of Veteran 
Integrated Services Networks (VISNs) to monitor and supervise 
their regional medical facilities. We have, over the last year, 
seen VHA struggle to comply with directives from VA Central 
Office (VACO) to set business rules appropriately on the 
computerized medical record.
    On our current ongoing review of VHA peer review processes, 
which is a result of the discussions we had at our Salisbury 
hearing, that data will demonstrate lack of VISN oversight of 
this process.
    I believe that veterans are receiving quality care 
throughout the VA system based upon our ongoing hospital 
reviews, our CAP reviews. However, my confidence that the 
proper controls are in place has been shaken by the reports of 
the last several months.
    Our recommendations in this Marion report are designed to 
improve some of the system-wide issues that we believe require 
correction and to address specific issues at Marion. In our 
report, we made 17 recommendations, which I would like to 
summarize.
    One, and the Under Secretary of Health concurred in all of 
these recommendations, one is that patients who have received 
substandard care be informed of their rights for benefit claims 
either through the tort system or other applicable laws.
    Two, that administrative reviews be conducted to determine 
whether or not senior officials within Marion should, in fact, 
receive some administrative disciplinary action.
    Three, to develop and implement a national quality 
management directive which goes to the issue of there being 150 
hospitals out there, each of which have a different management 
system in place, to address the data which should be collected 
and acted upon to ensure veterans receive quality care.
    Three, to improve the credentialing process, and there are 
a number of specific issues which can further delineate how to 
improve the privileging process.
    The most important aspect of that is to match the 
privileges, that is the procedures, both diagnostic and 
therapeutic, that a physician is allowed to perform at a 
hospital with the total capabilities of that hospital to 
support that care so that you do not do surgeries that you do 
not have the ICU staff, and other relevant staff, to support.
    In addition, we are concerned about the NSQIP reporting 
system. This is the first serious review we have undertaken of 
NSQIP data. We are concerned about the sampling methodologies.
    We would like to review with the VHA algorithms used to 
produce a forecast of expected mortality and we believe that 
there needs to be a review of the reporting process undertaken 
once data from that algorithm is obtained.
    And then we made a series of specific recommendations 
regarding Marion leadership, that they follow specific 
procedures.
    With that, I would like to end my statement and am pleased 
to take questions either by myself or with my staff.
    [The prepared statement of Dr. Daigh appears on p. 34.]
    Mr. Mitchell. Thank you. Thank you.
    I do have a couple questions. Do you believe that the VHA, 
or does the VHA, control the complexity of procedures performed 
at a facility?
    Dr. Daigh. I think that in general, the privileging process 
is viewed as a local process at an individual hospital. The 
view has been they are best determined and able to figure out 
what ought to be done at their hospital.
    And I believe that it is time for VHA to exert from the 
Central Office more control of that. And I believe that the 
Under Secretary of Health, through our report, has agreed that 
action should be taken to supervise that process more closely.
    Mr. Mitchell. And along with that, does the current VHA 
policy define what kind of documentation is needed to establish 
a provider's current competence to perform a particular 
procedure?
    Dr. Buck. No, sir, it does not. It specifies that they need 
to determine current competence, documents reviewed and 
rationale for conclusions reached, but does not specify what 
constitutes evidence of current competence.
    Mr. Mitchell. And what responsibility does the VISN have 
with respect to credentialing and privileging?
    Dr. Buck. VHA Handbook 1100.19, which is the Credentialing 
and Privileging Handbook for VHA, does not specify any VISN 
responsibility for credentialing and privileging.
    Mr. Mitchell. And one of the issues here is that the VA's 
Central Office did not learn of the excessive deaths following 
surgery until months after the fact.
    Can the VA rely on the system that is in place as its 
backdrop or does it need to do something else?
    Dr. Daigh. I think that in response, also, to your opening 
statement where the concern was a timely response to events 
like this, I think that it is the leadership and the people who 
work in a hospital who have to timely respond to issues that 
are ongoing. They have to track mortality rates. They have to 
review cases of individuals who die. They have to track 
infection rates. And they need to, in real time, address those 
issues. At Marion, that was not happening.
    I think NSQIP is not designed, and I think it is beyond its 
expectation, that it should in real time identify outliers. It 
is a catch-all, but it can never be a real-time program, I 
believe.
    The time required and the effort expended to collect the 
data elements, 200 some data elements to put into the program, 
and then the time to actually crank and do the statistical 
analysis does, in fact, take several months. So that is not 
what we should be relying on.
    We need to rely on the Chief of the service, the Chief of 
Staff, the nurses who are there looking at these cases, the 
leadership at the hospital, and throughout VHA to make sure 
that these issues are picked up and addressed timely.
    Mr. Mitchell. Thank you.
    And one last question. The VHA issued a new policy 
yesterday on the peer review process for reviewing potentially 
problematic outcomes.
    Are you aware of this and did you see any new policy before 
it was issued?
    Dr. Daigh. I am aware that they issued a policy yesterday. 
We did not comment and I did not see the policy before it was 
issued. Oftentimes we do see these policies before they are 
issued. We will, however, not be deterred from reviewing the 
policy and making comments back to VHA in light of our view of 
what peer review ought to be.
    Mr. Mitchell. And along with that, would you expect the VHA 
to want your input or the IG's input on a new policy, 
particularly in light of what happened at Marion?
    Dr. Daigh. I would hope that they would. We would require, 
in closing our recommendations that have to do with peer 
review, that we see such policy and agree that such policy is 
appropriate to deal with the issues that we have defined. So 
there is a process in place to ensure that we do address it. So 
I will just answer it that way.
    Mr. Mitchell. Thank you.
    Dr. Daigh. Yes, sir.
    Mr. Mitchell. Ms. Brown-Waite.
    Ms. Brown-Waite. Thank you, Mr. Chairman.
    And I sit there and I look at the table and we have five 
doctors there. I take it you all are physicians; is that 
correct?
    Dr. Daigh. Dr. Clegg is a statistician.
    Ms. Brown-Waite. Okay. Four doctors and a statistician.
    Probably one of the toughest battles I ever had in the 
Florida Senate was when I went up against doctors and said I 
think that the public should know when there are disciplinary 
actions taken, including in another State, and also malpractice 
claim settlements in excess of, at the time I believe it was in 
excess of $100,000. It was either $75,000 or $100,000.
    I was threatened. It was a very difficult time, but it was 
the right thing to do. And guess what? In Florida, we have what 
is called ``Physician Profiles.'' You can go online and find 
information out about any physician.
    Now, we all know that physicians get sued. Some specialties 
get sued more than others. But the reason why this drastic step 
was necessary was because doctors do not stand up and say Dr. 
X, Y, or Z is bad and dangerous for the patient. I am sorry, 
doctors, but that is the truth. Peer review is a joke.
    I am convinced that if more States had the availability of 
this process, that we would have weeded out bad doctors who 
either lose their license or have disciplinary action taken, 
that perhaps Bob Shank would still be here today and that we 
would not have had to put his widow, Katrina, through this.
    You know, I have to ask. When I read the report, this is 
the Office of the Medical Inspector General, and was told that 
some staff felt that when they voiced patient safety concerns, 
including those about rapid expansion of surgical scope of 
services, their concerns were dismissed as unimportant.
    Nurses who took their concerns to the Chief of Surgery were 
told that is the way the Chief of Staff wants it. One senior 
nurse took concerns directly to the Director and was told ``my 
hands are tied.''
    So even when there are nurses that recognize patients are 
being put in jeopardy, they are not listened to. And it is not 
just in the VA unfortunately and we all know that. It is not 
just in the VA.
    Doctors, when is your profession truly going to do no harm 
by being able to stand up and say, ``That doctor is a danger to 
the public?'' He might be your golfing buddy. He might be 
somebody who attends Christmas parties with you or holiday 
parties with you. But if he is a bad doc, he does not belong in 
there, especially in surgery.
    Would you come forward with some recommendations how we can 
better protect the patients? Because I can tell you that other 
legislators in other States were not successful when they tried 
to mirror the legislation I put in place. They were beaten down 
by the medical societies.
    Please, and you do not need to answer it now, please come 
forward with some recommendations so that patients can be 
better protected and give doctors the necessary backbone that 
it takes to protect the patient.
    Dr. Daigh. Yes, ma'am, we will do that.
    Mr. Mitchell. Mr. Walz.
    Mr. Walz. Well, thank you, Mr. Chairman, and thank you all 
for being here today.
    And I said it many times and I say it again that we are all 
here to make sure that the care for our veterans is improved, 
but I also hear us talking a lot and I see Ms. Shank sitting 
behind us, and I am wondering right now if she has heard 
anything that makes her have any confidence that this is not 
going to happen again.
    And as we hear these things, there are a few questions that 
I sure want to ask. The one thing is is that I am confident 
that Ms. Shank will get a peer review on this by a jury of her 
peers at some point who will make some decisions on this. And I 
trust the justice system, but when they hear her story, I think 
we will find out how that will work.
    But in the meantime, we have work to do. And I am, of 
course, a big supporter of the Office of Inspector General. I 
consider it to be a critical component in the quality of care. 
I consider it to be a critical component in oversight. And I 
know that the VA facilities who are delivering the quality of 
care, which there are many and many providers doing that, see 
you as partners in doing that.
    So this is a group that I am glad that is here this 
morning. I am going to read a couple statements that came from 
your report.
    You talked about the medical facility at Marion. The 
oversight reporting was fragmented, inconsistent, making it 
extremely difficult to determine the extent of oversight, 
patient quality, or corrective actions needed to improve.
    And then there was another statement that talked about 
inadequate quality management measures in place for tracking, 
trending, evaluation of data relating to patients undergoing 
cardiac catheterization.
    That type of data is longitudinal. It takes time to get 
that. You have your statistician here in Dr. Clegg.
    My question is, why did we not spot it earlier? Why after 
the fact do we see this? Why if this was an ongoing problem?
    And I guess in answering that, my goal, and I think the 
goal of this Committee, is to make sure that the Office of 
Inspector General, we have many hearings on this and it is very 
frustrating for many of us, do you have the personnel necessary 
to make sure you can review all these records and do you have 
the budgeting and the personnel necessary to do it because, 
unfortunately, we have heard it time and time again one of the 
largest government agencies has the lowest per capita number of 
inspector generals?
    I guess what I am trying to see, is there a correlation 
between not having the resources necessary and catching this 
before Ms. Shank has to come here and testify? So, please, go 
ahead.
    Dr. Daigh. I think there is a correlation. I have 60 people 
working for me. There are over 150 hospitals. There are half a 
hundred nursing homes. So I do believe that with more resources 
we could do a more effective job.
    We look at each facility on a once every 3 year basis. We 
focus on quality of care issues and procedures that are in 
place. And I would like to think that if there were defects 
like are at Marion and we were there, we would find them.
    We have found them in the past and reported them. With my 
last testimony, I indicated hospitals where we have done that.
    We were at Marion in 2005 and we did not find any problems 
with their quality procedures at that time. There were some 
changes, I believe, in the Marion leadership and in the 
organization of the hospital that I think may well have led to 
the current problem, but I cannot be sure that we did not miss 
something there.
    So, yes, I think with more resources, I could do more. 
Thank you.
    Mr. Walz. If you know offhand or if somebody knows here, 
what did we do this year for the 2008 budget? Is it going to 
get better or is it going to stay flat or is it going to get 
worse for the Office of IG as it shakes out?
    Dr. Daigh. Our budget in 2008 went up. Our budget in 2009 
is back below where we were before. So there is uncertainty as 
to what our long-term funding is. In that we just recently got 
a budget, it is uncertain whether we should hire individuals 
now and then have to fire them in several months. So that is a 
quandary that our leadership is dealing with.
    Mr. Walz. But we see leadership make a very intelligent and 
I guess professional judgment that more resources could have 
had some effect. I obviously understand some of this is 
subjective. And with that statement being made and, of course, 
we are going to give you those necessary resources.
    So if you are Ms. Shank sitting behind you, what should she 
leave with? Should she leave with, well, Congress says they are 
going to fix this, but the person who said we could have caught 
this is not going to get the resources necessary to catch it? 
Is that the conundrum we are in right now?
    Dr. Daigh. Yes.
    Mr. Walz. Okay. Thank you.
    Mr. Mitchell. Thank you.
    Mr. Space.
    Mr. Space. Thank you, Mr. Chairman.
    I recognize that all medical procedures, even marginally 
invasive ones, carry with them a certain recognized risk. But I 
guess the thing that concerns me about the Marion incident or 
incidents, in the case, the case of Mr. Shank, are the 
allegations of a cover-up, the suggestion that the original 
problems were blamed upon a heart attack or stroke, and then 
the subsequent statement by Ms. Shank that she still has not 
received all the medical records. That bothers me. And I think 
it is consistent with really a thread that we have seen in 
other aspects of the VA generally.
    And my question of you, Doctor, is whether or not your 
investigation revealed any evidence of a cover-up by any 
specific employees at the Marion facility, whether medical 
records have been forthcoming, or, alternatively, whether Ms. 
Shank has had a difficult time obtaining them, and, third, 
whether any of your recommendations pertain to transparency and 
honesty in the provision of records and statements regarding 
condition. Was that looked into as a part of your 
investigation?
    Dr. Daigh. Well, sir, we did not talk with Ms. Shank. We 
did review the records surrounding that case. And for privacy 
reasons, which sort of sound silly here, but we have properly 
considered the outcome of this case and are very saddened by 
it.
    With respect to whether she has gotten the medical records 
or not that she has requested, I simply do not know the answer 
to that. You would have to ask VHA whether there is a problem 
in her getting the records that she has requested.
    With respect to the issue of whether local individuals told 
her stories that were an attempt to cover up or hide what 
actually happened on a minute-by-minute basis, I am sorry. We 
have no insight as to those specific facts.
    I do think it would be revealing, though, to have Dr. Buck 
talk for a minute about the issue of what data one is supposed 
to submit as a physician for privileging and credentialing and 
then how that tracks through its difficulty in the system with 
respect to some of the doctors that are talked about here.
    Dr. Buck. Initially during the credentialing process, a 
physician actually submits an application in which they are 
supposed to disclose any pending actions against their licenses 
or any previous restrictions on their privileges or any present 
or former malpractice claims.
    The VA is supposed to obtain primary source documentation. 
I think this goes to Representative Brown-Waite's initial 
comments regarding the GAO report. That information is obtained 
from malpractice carriers or previous institutions in the case 
of malpractice claims.
    This information then is supposed to be evaluated and 
considered in the Professional Standards Board. Now, this is a 
group of other physicians at the facility.
    What happens at this level is that the individuals review 
the information and then make a determination or recommendation 
for credentialing or privileging a person at the facility.
    The credentialing process is about having these particular 
things addressed. The privileging process is about what a 
provider and an institution are competent to do. And that 
includes both specific aspects.
    So that is why some component of privileging is facility 
specific. That does not abrogate VHA's responsibility overall 
for the credentialing and privileging process. However, there 
are components to privileging that are inherently facility 
specific.
    These determinations are made. They go through the 
Professional Standards Board. They are signed off by the 
Service Line Chief, the Chief of Staff, and the Medical Center 
Director. These are the procedures that are in place.
    Now, what happened at Marion is that much of the 
information that was collected was not critically evaluated. 
There were discrepancies in what providers placed on their 
applications and what were actually obtained through primary 
source verification.
    And the Professional Standards Board failed to critically 
evaluate this information and to document current competence 
and the rationale for the conclusions reached in the 
credentialing and privileging process.
    One of the examples mentioned in the report is a provider, 
who at his previous institution, did not have privileges to 
perform colonoscopy. He came to Marion, and was granted 
privileges to perform colonoscopy with no discussion in the 
minutes regarding this individual provider's competence to 
perform this procedure.
    A nurse develops a report of contact within 2 months of 
this person starting employment at the facility that says he 
could not recognize the anatomy of the colon or perform the 
procedure properly in one case. And as a result of this, we 
could find no evidence that official action was taken against 
the provider's privileges or that this information was 
considered.
    Information collection is less of a problem than 
information evaluation.
    Mr. Space. Thank you, Doctor.
    Very briefly, has a determination been reached by you 
concerning whether, I am getting back to the specific case of 
Mr. Shank, whether the applicable standard of care was violated 
in this case relating to his treatment or condition?
    Dr. Daigh. Yes. Mr. Shank is one of the cases we identify 
as not meeting the standard of care.
    Mr. Space. Thank you.
    Mr. Mitchell. Ms. Brown-Waite.
    Ms. Brown-Waite. Thank you very much.
    I guess I would ask this to Dr. Daigh. Did Dr. Mendez 
indicate or anywhere in the credentialing process, were you 
told that he had restrictions in Massachusetts and that this 
also apparently had been disclosed in December of 2004?
    Dr. Daigh. I am going to ask Dr. Buck again to respond. Dr. 
Buck and Dr. Wesley went and met with Dr. Mendez and we 
subpoenaed documents from Massachusetts. So I will ask her to 
respond to your question.
    Dr. Buck. It is true that there is a letter dated in 2004 
which discloses that there was an active investigation ongoing 
in Massachusetts.
    The initial provider's application asked questions 
regarding whether there has been any disciplinary action taken 
against the license or whether there are pending administrative 
claims that might suggest there was problems with quality of 
care, somewhat vaguely worded questions.
    The actual complaint came from a malpractice carrier that 
essentially limited liability coverage, which in Massachusetts, 
is a reportable event to the State Licensing Board. This was 
reported and triggered an investigation of some malpractice 
claims in that State. And that is, in fact, what started in 
2004 but was not resolved for quite some time. It was actually 
two additional cases were added in 2005 and it continued on for 
at least 2 years.
    Ms. Brown-Waite. But I think the question is, the VA was 
aware of this possible problem that was out there from 2004. 
Did anyone follow-up on this to see the outcome?
    Dr. Buck. Well, the VA actually received documentation from 
the Massachusetts board that there were no disciplinary actions 
against this provider at the time of his hire because they 
report only final disciplinary actions, not pending ones.
    The actual information that he provided did indicate that 
there were some possible restrictions.
    Ms. Brown-Waite. Well, I do not think, with all due 
respect, Dr. Buck, I do not think you answered my question. Did 
anybody at the VA follow-up on this? If there was something 
pending there and the outcome was not yet resolved, did anybody 
at the VA follow-up to see what was the conclusion of that?
    Dr. Buck. They had information that were not followed up 
on.
    Ms. Brown-Waite. Okay. If I may ask Dr. Daigh just two 
questions. I know that the Marion facility is a very small 
facility. During your investigation, did you determine why the 
employees at that medical center never called the IG hotline or 
made complaints outside of the facility about patient care 
issues? Could it be that there was a fear of retribution if 
anyone was a whistle blower?
    Dr. Daigh. It is hard for me to know what is in the mind of 
individuals at Marion. We did during this timeframe, however, 
get a call from Marion to our hotline regarding one of the 
surgeons. The call, however, had nothing to do with their 
clinical care, but spoke to their use of language.
    We sent that request back to be acted upon. The facility 
held a Board of Investigation and made some findings as a 
result of that.
    So we have as a group thought about this a great deal and 
we simply do not have an answer for that, why they did not call 
us, the OMI, the newspaper. I just do not know.
    Once, however, there were several deaths in a row in August 
and the NSQIP team arrived, then clearly everyone was upset at 
that point and began to talk.
    Ms. Brown-Waite. Let me just extend a comment to my 
colleague, Mr. Walz. We have an obligation, I believe, to make 
sure that the funding for the Inspector General not only is the 
same as it was in 2008, and from what Dr. Daigh believes, the 
President's budget will have it reduced even more, I think it 
is our obligation here, and I know everyone agrees with me, to 
fight for additional funding because that is the way that I 
believe that these kind of constant problems can be resolved, 
by having adequate funding for the Inspector General.
    Mr. Walz, I know how passionate you and every Member of 
this Committee is about veterans. And I think that is something 
that on both sides of the aisle we feel very strongly about.
    Thank you, Mr. Chairman.
    Mr. Mitchell. Thank you.
    And thank you all very much for your testimony.
    Dr. Daigh. Thank you, sir.
    Mr. Mitchell. I welcome panel three to the witness table. 
Dr. Gerald Cross is the Principal Deputy Under Secretary for 
Health at the Department of Veterans Affairs. Dr. Cross, we 
welcome you, and your insight. I would like to ask you to 
introduce your team before you begin your statement.

  STATEMENT OF GERALD M. CROSS, M.D., FAAFP, PRINCIPAL DEPUTY 
  UNDER SECRETARY FOR HEALTH, VETERANS HEALTH ADMINISTRATION, 
  U.S. DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY KATHRYN 
  ENCHELMAYER, M.D., DIRECTOR OF QUALITY STANDARDS, VETERANS 
 HEALTH ADMINISTRATION; JOHN PIERCE, M.D., MEDICAL INSPECTOR, 
   VETERANS HEALTH ADMINISTRATION; NEVIN WEAVER, DIRECTOR OF 
     WORKFORCE MANAGEMENT AND CONSULTING, VETERANS HEALTH 
ADMINISTRATION; AND HON. PAUL J. HUTTER, GENERAL COUNSEL, U.S. 
                 DEPARTMENT OF VETERANS AFFAIRS

    Dr. Cross. Good morning, Mr. Chairman and Members of the 
Subcommittee. And I thank you for the opportunity to discuss 
the recent reports from the VA's Office of the Inspector 
General and the Medical Inspector on the quality of surgical 
care provided at Marion.
    I am accompanied by Dr. Kate Enchelmayer, who is the 
Director of Quality Standards; Dr. John Pierce, VHA Medical 
Inspector; Nevin Weaver, VHA's Chief Officer of Workforce 
Management and Consulting; and Paul Hutter, our General 
Counsel.
    These reports were issued yesterday and I understand that 
the Committee has already received them. As the Committee 
Members know, these investigations yielded troubling results.
    Mr. Chairman, my heart goes out to the patients who 
received substandard surgical care and the families affected at 
Marion. I am angry that such a thing could have happened at one 
of our hospitals. And on behalf of the VA and again to the 
family that I spoke to before, I apologize to those patients 
and to their families.
    But let me assure all of you that VA management did not sit 
idly by once we learned of the problems at the Marion facility. 
We first learned the extent of the problem on August 30, 2007, 
and major surgeries were stopped that same day.
    On September 14, we removed the Hospital Director. We 
removed the Chief of Staff and we removed the Chief of Surgery 
from their positions. Since then, a new leadership team has 
been in charge, ensuring quality of care to our veterans.
    Yesterday, we began calling all veterans who we believe may 
have been harmed by any substandard care, surgical care at 
Marion. And in accordance with our ethics policy, we will set 
up appointments within the next 2 weeks to review their care 
with them and we will help them and their families in their 
efforts to receive compensation.
    We have set up a toll-free number for patients and their 
families who are concerned about the care they received at 
Marion.
    And, finally, we are working diligently to ensure that the 
issues that arose at Marion are not present in other 
facilities. We will do all we can to prevent problems like this 
from occurring anywhere in the future and we are determined to 
quickly correct any problems that we uncover.
    Mr. Chairman, there were four significant areas in which 
Marion employees failed to comply with regulations and VHA 
directives and procedures. Those were leadership, 
credentialing, privileging, and quality management.
    I believe the bottom line is this was a failure of 
leadership. To remedy this, we have initiated an Administrative 
Board of Investigation to review both quality in care issues 
and the conduct of individual employees.
    The Board is empowered to recommended specific disciplinary 
actions against individuals. They can make such recommendations 
on any employee they choose at any level of responsibility.
    The employees at Marion have been assured that whatever the 
Board's findings, the former Director and Chief of Staff will 
not return to the facility.
    Regarding credentialing and privileging, we are undertaking 
a full review of our credentialing and privileging processes 
and we will increase our vigilance to make sure the 
representations our facilities make to us are accurate and 
complete.
    We have chartered a group to link the level of support 
services provided at a facility with the complexity of 
procedures that can be performed at that facility.
    We have created a work group on surgical processes to 
review our current strategies for improving quality, to examine 
the way in which we analyze surgical results, and to define a 
quality assessment process all hospitals can use to better 
assess their quality of care.
    In quality management, we have already established a new 
directive to augment our reviews and have more to follow. And 
this will be for our facilities and will require external 
reviews of care and other changes.
    Mr. Chairman, we have learned a hard lesson from these 
events. Among the lessons we have learned are the value of 
prompt and decisive action. We must link the capabilities of 
hospitals to the complexity of procedures they perform. We must 
strengthen the peer review system, especially at small 
hospitals. And, finally, we have learned the meaning of 
President Reagan's statement, trust, but verify.
    Let me close with sincere apologies to all who have 
received any substandard care at the Marion surgical program, 
to their loved ones, to the Marion community, and to all of 
America's veterans and their families.
    Mr. Chairman, I thank you and the Committee for your time.
    [The prepared statement of Dr. Cross appears on p. 39.]
    Mr. Mitchell. Thank you.
    Dr. Cross, between October 1 and December 31, 2006, Marion 
had seven deaths following surgery when the expected number 
according to NSQIP was two. We have been told that as a ratio, 
this is the highest deviation from the expected deaths ever 
reported. That information did not come to the attention of the 
Central Office until August. This is clearly unacceptable.
    The VA cannot rely solely on local facilities to identify 
and deal with their own problems. What is the VA doing to make 
sure management can respond to serious problems in a timely 
fashion?
    Dr. Cross. Mr. Chairman, you are absolutely right. We 
cannot wait for NSQIP to give us those results. NSQIP was very 
helpful in this case as a backup system to give us that kind of 
information ultimately when the people close to the local 
facility did not do what they should have.
    First and foremost, we need to demand of our leaders that 
they take their responsibilities and carry them out 
effectively. I do not believe that happened at Marion.
    But beyond that, we have to put policies in place now to 
make sure that, particularly in things like peer review, that 
it is not just left up to the local facility, particularly at a 
small facility like Marion, but that we have external reviews 
that are done elsewhere. And, indeed, it is my intention that 
those external reviews, a portion of them will be done outside 
the VA entirely.
    Mr. Mitchell. How do you know that there are no more 
Marions out there? If you rely strictly on NSQIP for this 
conclusion, as you said, we know it is out of date. So how do 
we know that there are no more Marions out there?
    Dr. Cross. That is a question that I have thought long and 
hard about, Mr. Chairman, and my staff has as well.
    First of all, let me point this out. We found the problem. 
We took action on the problem, and it was rather decisive 
action, at removing the entire leadership of the facility.
    But that system that found the problem is also in place 
elsewhere. We have looked at that data. The data does not 
suggest that we have a problem similar to Marion elsewhere in 
our system. But that is not enough.
    We are taking further action. We have already met with our 
National directors and pointed out the lessons learned as we 
knew them at the time last year in regard to Marion.
    We are putting in place training and other measures to make 
sure that at all levels of our organization people understand 
what to look for to make sure that this does not happen.
    Mr. Mitchell. Under what conditions will Marion be 
permitted to reestablish its surgery program?
    Dr. Cross. I have been asked several times again when will 
surgery be resumed at Marion. And I have assured everyone that 
we have no timeline and no pressure to move that forward.
    I think that we really need to reassess what is done at 
Marion. I told you we have established a surgery group to look 
at the complexity of surgery and the type of facility at which 
that is done.
    I think that we will have to reconsider similar facilities 
to Marion and Marion itself as to what their future is in 
regard to a surgery program.
    Mr. Mitchell. Limiting privileges at individual hospitals 
to those procedures that the hospital itself has the services 
to support, is a great idea. But we have heard that Marion 
granted privileges to physicians apparently without any review 
at all. Even if the hospital can support a procedure, our 
veterans need to know that the doctor has the experience and 
skill to perform those procedures.
    What is the VHA going to do to ensure the policies about 
experience and review of qualifications are followed at the 
local facilities?
    Dr. Cross. Well, we have a number of revisions and ideas on 
how we can do that. I am going to ask Kate Enchelmayer to 
support me in expanding on this answer.
    Ms. Enchelmayer. Thank you, Dr. Cross.
    We actually recognized quite early on that it is the 
medical staff leadership that is responsible for the review and 
the documentation of an individual's competency.
    So we actually implemented back, actually last July, 
training and have required all medical staff leaders at each 
facility to take this training that reinforces their 
responsibilities in this process and their responsibility in 
reviewing the competency of practitioners as it comes forward 
for initial appointments and initial privileging, as well as 
ongoing monitoring. We are reinforcing requirements of the 
Joint Commission and making sure that the leadership 
understands that they do have this responsibility.
    We also, in October, put in a requirement. We have an 
electronic credentialing system, VetPro, which consolidates 
everything, all the information, all the primary source 
information, as well as all the secondary source that we do get 
from the Federation of State Medical Boards and the National 
Practitioner Data Bank.
    And we actually are now mandating that service chiefs who 
are the frontline making the recommendations for granting these 
privileges actually document in this electronic record 
themselves their recommendations, including requiring a 
competency statement of them so that they will be able to 
incorporate this information. But it does put all the 
information directly in front of them as they are making these 
recommendations.
    So these are some of the actions we have taken, as well as 
we will be looking at the complexity work group as it comes 
forward. And we have been discussing a number of other 
activities.
    Mr. Mitchell. I have one last question. The VHA issued a 
new policy statement yesterday on the peer review process and 
reviewing potentially problematic outcomes.
    Who reviewed this before it was issued and did the Medical 
Inspector review this? We just heard earlier the IG did not. Is 
it standard practice not to include the IG in statements like 
this and do you not think it would be essential to get the IG's 
involvement in this after they just got through investigating?
    Dr. Cross. Mr. Chairman, I am willing to get a good idea 
from anybody who will give it to me, and if the IG has some 
ideas. Here is what we did.
    We actually had a meeting with them earlier this week and 
discussed the basic findings and what actions we were planning 
on taking. That was very valuable to me in writing and 
approving that directive that came out. That directive is one 
of several that we have underway. They are going to get more 
and more specific in terms of the external peer review 
component.
    And, again, I am happy to work with the IG on this. I meet 
with them frequently. We have an excellent relationship. I take 
their ideas very seriously and will continue to do so.
    Dr. Pierce. Sir, I was involved in that peer review 
directive being redone.
    Mr. Mitchell. Thank you.
    Ms. Brown-Waite.
    Ms. Brown-Waite. Thank you very much.
    Dr. Cross, I am seeing far too much of you with all due 
respect. Those of us who sit on the Oversight panel are very 
concerned about this continuing process where I believe 
veterans are harmed and/or the once great VA healthcare system 
is substantially impaired.
    When you said that the Chief of Staff was removed and the 
Chief of Surgery also was removed, what does removed mean? Are 
we just rearranging the deck chairs? Does anybody at VA ever 
lose their job for gross negligence?
    Dr. Cross. You bet. And what it means in terms of removed 
in this case is that they were taken away where they had no 
further responsibility----
    Ms. Brown-Waite. Is that like the witness protection plan?
    Dr. Cross. I am going to ask Nevin Weaver to give you the 
details.
    We are part of the government. We do have to follow the 
government safeguards that have been put in place. But we made 
sure within minutes, within hours that those individuals were 
removed from the facility and had no longer any relationship to 
the Marion facility.
    I will ask Mr. Weaver to comment.
    Ms. Brown-Waite. Sir, I think the question is, are these 
two individuals, the previous Chief of Staff for the hospital 
and Chief of Surgery, in any position in the VA today 
overseeing or performing any medical practices?
    Dr. Cross. No.
    Mr. Weaver. Yes. Let me talk a little bit about that. We 
did take 12 personnel actions that are in process. We have a 
combination of people who have reassigned, people who were 
actually removed.
    And as you mentioned about the Director and the Chief of 
Staff, they are going to be a part of our Administrative 
Investigative Board which has begun yesterday. And we will be 
reviewing their involvement and then taking appropriate 
actions.
    Ms. Brown-Waite. I certainly hope that none of these 
actions will be taken against the nurses who actually spoke up 
but who felt that (A) nobody cared what they said, and (B) that 
there was a lot of intimidation going on at that facility.
    Have you all looked into that and do you have any remedies 
for other situations where quality of care is really necessary?
    I find it also amazing that the Joint Committee on 
Accreditation of Healthcare Organizations (JCAHO) gave their 
approval to this facility in August of 2007 while all this was 
going on. This is just absolutely amazing.
    Dr. Cross. Let me clarify one thing I told you earlier. The 
individuals were put on administrative leave.
    Mr. Weaver On detail.
    Dr. Cross. And the Administrative Board of Investigation is 
the thing that will now determine their responsibility and 
disciplinary actions, whatever that may be.
    In regard to the Director and the Chief of Staff, I said in 
my opening statement that they would not be returning to the 
facility regardless of the findings.
    Furthermore, the individuals have been placed at the VISN 
headquarters, which is, I think, over a hundred miles away from 
Marion, to just do routine administrative duties on a day-to-
day basis while this investigation continues.
    Ms. Brown-Waite. So it is basically administrative leave 
with pay and they are doing something administratively, not 
medically? Is that what I understand you to say?
    Dr. Cross. That is my understanding, yes.
    Ms. Brown-Waite. Okay. Dr. Cross, you know that we have had 
hearings in the past on bonuses. As a matter of fact, we had 
one last year.
    Can you tell this Committee if any of the senior management 
at Marion received bonuses and, if so, how much?
    Dr. Cross. I do not have that information.
    Ms. Brown-Waite. Mr. Chairman, I would like to ask 
unanimous consent to have that information supplied to the 
Committee.
    Mr. Mitchell. Without objection.
    [The information was provided in the response to Question 1 
of the Post Hearing Questions for the Record letter from VA 
dated March 3, 2008, which appears on p. 56.]
    Ms. Brown-Waite. I appreciate that very much.
    The other thing is, and this will be my last question, 
there are about 20 other facilities in the VA, somewhat similar 
size to Marion.
    Why are you waiting until March to check these facilities?
    Dr. Cross. We are not waiting until March to check those 
facilities. What we are doing, we started the credentials 
review that Ms. Kate Enchelmayer can comment on last year. And 
that is a credentialing review of all the staff at all those 
facilities across the Nation. And that has been underway now 
for some time.
    I would like to ask Kate to comment on that.
    Ms. Enchelmayer. Certainly. Thank you.
    We actually, the 7th of October, went into our VetPro, our 
electronic credential system, and extracted approximately 
17,000 names of the 56,000 licensed, independent practitioners. 
These are individuals who responded to supplemental questions 
that they had allowed a license to lapse or had a licensure 
action. They had responded to the questions about 
administrative claims or medical malpractice against them.
    They also have had documented reports of information from 
the licensing boards or NPDB, reports given to us as we queried 
the NPDB, and also responses from the Federation of State 
Medical Boards.
    That information was compiled and distributed to each 
individual facility. Each individual facility has already done 
a review of these individuals. They have looked at the 
information that we had available, looked at the documentation 
and the consideration of these people as they were appointed to 
the facility or reappointed to the facility and privileges 
granted.
    This has gone through VISN. It has had a VISN review. And 
we are in the process of actually collating information on the 
dollar figures that we have gotten over the many years of the 
National Practitioner Data Bank and the reports there. We have 
dollar figures. We have the reports. We have the information.
    We are also looking at the licensure action information. We 
know that we have no physician or licensed independent, 
practitioner who is working for us who has a revoked license or 
has surrendered a license for cause after written notification 
of a revocation----
    Ms. Brown-Waite. May I stop you right there?
    Ms. Enchelmayer. Certainly.
    Ms. Brown-Waite. I have found that when physicians know 
that they are being brought up on disciplinary action, what 
they do is they hand their license in at the State they are in, 
which in most States, will stop the disciplinary action. So 
they have voluntarily surrendered that license in another 
State. I see you shaking your head in agreement with me.
    Ms. Enchelmayer. We have the requirement. The other half of 
the requirement is that if they surrender their license after 
written notification of a potential revocation for cause, then 
they cannot work for us until that license is fully reinstated. 
And that information is confirmed with the State Licensing 
Board, so we are at the mercy of the State Licensing Board to 
give us the information that we are requesting.
    But we do have the requirement that if it is a voluntary 
surrender, once they are notified that the action is pending, 
they may not work for us until that license is fully restored.
    Ms. Brown-Waite. Ma'am, the point at which someone realizes 
that disciplinary actions are going to be taken or that they 
are going to be involved in a major lawsuit, at that point, and 
you know it as well as I do, at that point, it is I am going to 
move to Florida or I am going to move to California and I am 
voluntarily giving up my license in this State. So you need to 
peel that onion apart a little bit more than just----
    Ms. Enchelmayer. We are working very hard at that.
    Ms. Brown-Waite [continuing]. If they have disciplinary 
actions.
    Ms. Enchelmayer. We are working very hard at that. We 
implemented again back in October related to the medical 
malpractice issues that you have raised, we have implemented a 
VISN level review based on certain triggers in the medical 
malpractice payment process.
    If a practitioner has three or more medical practice 
payments period, they must be reviewed by the Chief Medical 
Officer (CMO) at the VISN level to review the process that the 
facility has used in their review and the documentation of that 
process.
    The second trigger on medical malpractice payment is if 
they have two or more malpractice payments totaling a million 
dollars or more, and the third trigger point is a medical 
malpractice payment of $550,000, a single malpractice payment.
    And this is based on National Practitioner Data Bank data 
of all physicians who have been reported to them since the 
founding of the data bank in 1990. And that is the 85 percent 
cut point for the physicians of those three different 
categories.
    So we have implemented that and those were the standards 
that were used by the VISNs when they reviewed the data that 
they were looking at back in November and December. And we are 
also looking at that.
    To date, we have calculated that 619 practitioners out of 
the 56,000 licensed, independent practitioners we have would 
have triggered a review by the CMO based on medical malpractice 
payments.
    Ms. Brown-Waite. Just one other question, Mr. Chairman, if 
you will.
    I do hope that you will take into consideration that some 
specialties are sued more than others.
    Ms. Enchelmayer. Yes.
    Ms. Brown-Waite. Obviously orthopedic, OB/GYNs, and many 
times oncologists alone. So take that into consideration.
    Ms. Enchelmayer. We are doing that right now, ma'am.
    Ms. Brown-Waite. Okay. Thank you very much.
    And I really do yield back.
    Mr. Mitchell. Thank you.
    Mr. Walz.
    Mr. Walz. Thank you, Mr. Chairman.
    And thanks, Dr. Cross, and your team.
    Ms. Shank, when I opened with my statement, I said the 
least we can do is show you the respect to look you in the eye 
and talk about this issue which we have been doing over about 
the past hour.
    And the one thing I can tell you as an honest assessment, 
you have heard it here, and this place and this Committee is a 
place where it is not business as usual for Congress. You heard 
the Ranking Member's passion on this issue and the cooperation.
    I would like to tell you that I just returned recently from 
a fact-finding trip on the medical care our soldiers are 
receiving out in the field in Afghanistan and Iraq. And that 
trip was put together and led by Mr. Bestor on the Majority 
side and Mr. Wu on the Minority side. And I can tell you that 
politics did not enter into that at all. It was all about fact 
finding and seeing what is happening.
    And I am pleased to tell you that the care that is provided 
for our soldiers down range is unprecedented in world history. 
And I think it is probably worth noting that a person highly 
responsible for that is Dr. Cross and his training of many of 
those physicians in the position he was in.
    He came to the position he is in right now, if I am not 
mistaken, Dr. Cross, in July of 2007. So he took on this task 
and I am telling you this, Ms. Shank, to let you understand 
that this is not business as usual, that you coming here, 
nothing we say is going to make your pain any better, but the 
people you have here are the people who can make decisions.
    You have the passion of the Chairman and the Ranking 
Member. You have the people here, and IG are the oversight on 
this, and you see the gentleman who is responsible for this in 
making sure that it does not happen again answer hard questions 
and get quizzed on this.
    So I would have to tell you that in terms of the way this 
place normally works, unfortunately, it does not look like this 
and the way it should be, that I am optimistic. But as the 
Ranking Member and the Chairman have said, there are issues we 
need to bring up.
    Dr. Cross, the 17 IG recommendations on this specific issue 
at Marion, you concurred that those were issues?
    Dr. Cross. Yes, sir, we do.
    Mr. Walz. The only thing I am questioning, and this is 
where I get frustrated with business as usual, what assurance 
do we have that those are going to be done in a timely matter?
    That is not something we were given. And I understand 
procedures and things. I would just ask you, Dr. Cross, to tell 
me how can we, in our oversight capability, be able to see that 
those things are hitting the benchmarks.
    Dr. Cross. We will give it to you and without hesitation. I 
should say that, you know, because of the relationship that we 
have with the OMI and the IG, we did not just start working on 
the recommendations this week. We actually started months ago 
because we in talking with the OMI and IG had some sense of 
what the issues were going to be and so we did not wait. We 
went ahead and started putting these things together at that 
time.
    Mr. Walz. Well, I look forward to it. It is incumbent upon 
us to exercise our responsibility to make sure that is 
happening. There is supposed to be layers in place to make sure 
these types of things do not happen. They obviously failed you, 
Ms. Shank and failed your husband, Bob. The issue at hand now 
is to do everything we can to make sure they do not fail in the 
future. And I think the questions that were asked, I am very 
appreciative of the hard questioning and the point of attack on 
this.
    I can tell you something I was just notified of, that on 
February 13th, we will be holding a hearing in this 
Subcommittee on the IG's budget. And you heard the Ranking 
Member's commitment to making sure we get this thing right and 
we will be working on that.
    So it is not lip service for a short time and then we brush 
away any of the inconveniences. This is a case of understanding 
that this has to be fixed.
    So for all of us here today, it is an unfortunate reason 
that we are here, but it is also, I think, in the right spirit 
that we are going to move this thing forward and that 
responsibility is being taken. And we're going to make sure if 
responsibility is not taken, that it will be.
    Mr. Mitchell. One thing just before he comes back. Can we 
make sure that Ms. Shank gets the records that she is after?
    Dr. Cross. Yes, sir.
    Mr. Mitchell. Thank you.
    Mr. Walz. The last question that counsel asked, Dr. Cross, 
was on this issue and that you are going to provide those to us 
and those timelines of when the 17 recommendations will be. How 
can we expect to get that, I guess, being a little more 
specific?
    Dr. Cross. I am going to get them to you as fast as I can. 
You know, we are still drafting them and we have to make sure 
that it is a quality document, that we have covered the entire 
gamut. We still have work to be done. I am not sure what the 
exact process is, but it is my hope----
    Mr. Walz. Do your staff know that I can call over and keep 
following up?
    Dr. Cross. Yes, sir. And I will work on that call.
    [The timeline was provided in Appendix A, of the January 
28, 2008, report, Healthcare Inspection: Quality of Care 
Issues, VA Medical Center, Marion, Illinois (Report No. 07-
03386-65), which appears on p. 45.]
    Mr. Walz. Okay. Thank you.
    And I yield back.
    Mr. Mitchell. Thank you.
    I would just like to make one closing statement, that I 
joined with Mr. Costello and Mr. Whitfield and Mr. Shimkus in 
introducing H.R. 4463, the ``Veterans Healthcare Quality 
Improvement Act.'' And I believe this bill is a first step in 
improving the desperate situation that the VHA is in at this 
time.
    And what I am asking is that if you would review this and 
give us your input because we want to make sure that we are on 
the right track and we are doing the right thing.
    And I also ask the Members of this Subcommittee to join on 
as joint sponsor.
    Dr. Cross. Yes, sir.
    [The Administration views for H.R. 4463, the ``Veterans 
Healthcare Quality Improvement Act,'' appear on p. 62.]
    Mr. Mitchell. And this concludes the hearing. And I want to 
thank all of our panelists.
    And, Mrs. Shank, again, our condolences.
    Thank you.
    [Whereupon, at 11:43 a.m., the Subcommittee was adjourned.]



















                            A P P E N D I X

                              ----------                              

        Prepared Statement of Hon. Harry E. Mitchell, Chairman,
              Subcommittee on Oversight and Investigations
    This hearing will come to order.
    We are here today to address the fallout from events at the Marion, 
Illinois, VA Medical Center. I was troubled to find out about a pattern 
of deaths at this VA Hospital that went unaddressed . . . and further 
concerned that the system in place to catch this substandard care has 
no rapid response measures.
    According to the VA's Office of Medical Inspector, from the 
beginning of 2006 through August of 2007, nine patients at Marion died 
as a result of substandard care. Another 34 had post-operative 
complications resulting from substandard care.
    The Marion, Illinois, VA Medical Center serves veterans in southern 
Illinois, southwestern Indiana, and northwestern Kentucky. In August of 
2007, the Veterans' Health Administration noticed a disturbing 
pattern--patient deaths following surgery were more than four times the 
average.
    VHA sent an inspection team. They suspended all surgeries at the 
hospital and placed the leadership of the hospital--including the chief 
of surgery--on administrative leave.
    The VHA responded quickly when the data became available, but that 
data was more than six months old.
    The data came from the National Surgical Quality Improvement 
Program, known as NSQIP. This program collects information from several 
hundred thousand surgeries performed at VHA facilities every year. 
Unfortunately, NSQIP reports only become informative an average of five 
months after an incident . . . due to a lag in gathering and inputting 
the data.
    When VHA responded in August 2007 to the pattern of excessive 
deaths at Marion, they were using data that covered October 2006 to 
March 2007.
    This is unacceptable. The VHA cannot respond to problems in its 
hospitals if it does not know what they are.
    There must be controls to ensure that doctors and other health care 
providers have the required credentials and are fully qualified to 
perform the specific medical procedures they undertake. Events at the 
VA Hospital in Marion, Illinois, tragically show what happens when 
these essential controls break down.
    The Inspector General and Office of the Medical Inspector found 
that there is a serious hole in the system. The VA does not have a way 
to identify all jurisdictions where a physician has been--or is--
licensed. This is because some states do not have an electronic 
registry or are not willing to share records.
    The VHA requires that surgeons must receive a clinical privilege to 
perform specific procedures at the hospital; the IG and OMI discovered 
that this process had been abused at Marion. In fact, privileges were 
granted at Marion regardless of experience or training.
    Even more disturbing is that privileges were granted at Marion for 
procedures that the hospital didn't even have the facilities to 
accommodate, such as radiology access 24 hours a day.
    The events at the Marion hospital demonstrate a failure in the VA 
system to quickly bring important information forward so that the VHA 
can respond with appropriate action. This is a real problem.
    Our first witness today, Ms. Katrina Shank, drove her husband, Bob 
Shank, to Marion for a routine surgery. Bob passed away within 24 hours 
of the procedure due to the substandard care at the hospital. I believe 
that if the safeguards had been in place and administrators had been 
properly notified of past incidents, Bob's death could have been 
prevented.
    I want to know why no one outside of Marion was aware of the 
problems until August 2007 and what VHA is doing to make sure that this 
failure of information flow never happens again.
    Additionally, what is VHA going to do to fix the serious quality 
management issues, credentialing and privileging that have been 
disclosed by this tragedy?
    I am afraid that once we start looking at this issue deeper, we may 
find that what happened at the Marion hospital isn't an isolated 
incident.
    Our veterans served honorably to protect our Nation. We have a 
responsibility to take care of them when they come back home.

                                 
             Prepared Statement of Hon. Ginny Brown-Waite,
Ranking Republican Member, Subcommittee on Oversight and Investigations
    Mr. Chairman, thank you for yielding.
    Mr. Chairman, when news reports came out last year showing a spike 
in surgical deaths at the Marion, Illinois VA Medical Center, we on 
this Committee were concerned. We wanted to know whether this was an 
isolated incident or more widespread than reported.
    On September 14, 2007, Ranking Member Buyer and I wrote a letter 
asking for an investigation by the Office of the Inspector General into 
the spike in surgical deaths. I ask unanimous consent that a copy of 
this letter be submitted for the official hearing record.
    I hope to hear from the IG this morning about the results of this 
investigation. On November 6, 2007, our Senate counterparts held a 
hearing on this issue as well. During this hearing, GAO testified that 
in their 2006 review of VA's credentialing requirements, it made four 
recommendations that VA medical facility officials must:

    1.  Verify that all state medical licenses held by physicians are 
valid;
    2.  Query Federation of State Medical Boards (FSMB) database to 
determine whether physicians had disciplinary action taken against any 
of their licenses, including expired licenses;
    3.  Verify information provided by physicians on their involvement 
in medical malpractice claims at a VA or non-VA facility; and
    4.  Query the National Practitioner Data Bank to determine whether 
a physician was reported to this data bank because of involvement in VA 
or non-VA paid medical malpractice claims, display of professional 
incompetence, or engaged in professional misconduct.

    I am interested to hear if the VA was following all of the 
recommendations. If they were, I would like to know how a physician who 
lost his license in the state of Massachusetts, but was still licensed 
in the state of Illinois, was allowed to practice at the VA facility in 
Marion, IL.
    It is imperative that we explore the circumstances of this 
situation to prevent similar cases in the future. To do this, several 
questions need answering.
    How current are the national databases available to maintain 
licensing standards, and how is information on licensing actions 
disseminated to other states?
    The current NPDB system does not inform the agency of actions taken 
against a license, although I understand that they are developing a 
prototype to provide Proactive Disclosure Services. Has VA enrolled in 
this prototype?
    Committee Members have been told repeatedly that the VA has one of 
the best healthcare systems in the nation. The VA healthcare system is 
one that many other hospitals and healthcare systems are trying to 
emulate.
    However, when the VA maintains credentialing for a practitioner 
whose license has been revoked in another state, we must question the 
quality of care being provided to our Nation's veterans.
    Also, it is apparent that the scope of privileging and the 
commensurate appropriateness of staffing support have not been afforded 
the professional due diligence of responsible senior management. VA's 
premier healthcare delivery system is marred by some senior managers 
asleep at the wheel.
    When veterans come to VA hospitals and outpatient clinics, they 
should not have to worry about whether or not their physician has a 
valid license to practice medicine.
    Veterans should not have to worry about whether the state of 
Massachusetts has revoked the license of a doctor practicing in 
Illinois for quality of care issues.
    Our veterans trust that the VA does its part to ensure 
practitioners in VA medical facilities are the best trained and most 
qualified individuals to care for them. For the VA to do anything less 
is unacceptable.
    Thank you for calling this hearing, Mr. Chairman. I look forward to 
the witness testimony.

                                 
             Prepared Statement of Hon. Jerry F. Costello,
        a Representative in Congress from the State of Illinois
    Chairman Mitchell and members of the Subcommittee on Oversight and 
Investigations, I would like to thank you for giving me the opportunity 
to be a part of this hearing addressing the issue of ensuring the 
quality of healthcare practices within the Veterans Health 
Administration (VHA).
    First, I want to give my condolences to the families affected by 
the tragedy at the Marion VA Medical Center, including the wife of Mr. 
Robert Shank III, Mrs. Katrina Shank, who is here today to testify.
    As the representative of the congressional district which includes 
Marion, Illinois, I know that much of the staff at the Medical Center 
does good work providing healthcare for Veterans. For this reason I am 
all the more troubled that faulty leadership at the Medical Center and 
significant institutional problems have resulted in the tragic deaths 
of at least nine individuals in the past two years and in significant 
health problems for numerous others. The system has failed these 
veterans, and their families, who have given a part of their lives to 
the service of this country. While it is too late to help these 
veterans, we must make sure that these problems are corrected to 
restore the integrity of the VHA system.
    The report addresses four major problems that were found at the 
facility: quality management, the credentialing process, the 
privileging process, and a lack of leadership by senior staff. In all 
of these cases there was a combination of exceedingly poor management 
in parts of the facility and a lack of sufficient, systemwide rules 
ensuring checks on the quality of health care. As such, both the Marion 
VAMC's practices and VA Department rules relating to quality healthcare 
assurance need to be reviewed and strengthened accordingly. In 
addition, while the credentialing of health care providers can be 
viewed as a problem of the health care system as a whole, there is much 
that the VHA can do to address this problem.
    While I am pleased that the VA discovered and investigated the 
problems at the Marion VAMC, this must be the first step in 
reevaluating and reforming fundamental procedures in the VHA. 
Representatives Shimkus, Mitchell, Whitfield and I have recently 
introduced legislation to address many of these issues. The Veteran's 
Health Care Quality Improvement Act would:

    1.  require greater disclosure of a physician's history of 
malpractice lawsuits and status of being licensed
    2.  establish within the VA, as well as in each Veteran Integrated 
Services Network (VISN), a Quality Assurance Officer responsible for 
ensuring quality healthcare is provided
    3.  require a complete review of VA policies and procedures which 
ensure quality care

    While I will work to enact this legislation into law, it is 
seriously troubling that these controls were not already standard 
practice within the VHA.
    As these investigations demonstrate, there clearly needs to be a 
substantial revamping of the credentialing and privileging processes, 
as well as other institutional changes within the VHA to assure quality 
healthcare. I look forward to the panel's testimony regarding their 
investigations. I also hope to hear suggestions of how reliable 
controls can be implemented in our medical centers and outpatient 
clinics so that our Veterans receive the quality healthcare that their 
country owes them.
    Mr. Chairman, I again thank the Subcommittee for allowing me to 
participate today, and I look forward to the testimony of the 
witnesses.

                                 
        Prepared Statement of Katrina Shank, Murray, KY (Widow)
    Mr. Chairman, Ladies and Gentlemen of this Committee:
    My name is Katrina Marie Shank; I am sitting before you today 
because I am the widow of Robert (Bob) Earl Shank III of Murray, 
Kentucky, who passed away August 10, 2007, after a routine Laparoscopic 
Gallbladder Surgery at the Veterans Administration Hospital in Marion, 
Illinois.
    Bob was a United States Air Force Veteran, who served his country 
from July 30, 1975-July 13, 1977, discharged with a service character 
of ``Honorable.''
    I met my husband in July 1997, when he started working at the 
Maytag plant that I was hired into in September 1995. We were co-
workers and friends for six and a half years prior to our marriage on 
June 25, 2004.
    Bob was a reliable hard worker and was promoted to group leader in 
our department, a position he held for several years. Upon the closure 
of the Maytag plant on December 26, 2006, we relocated to Murray, 
Kentucky, January 27, 2007, to be closer to my family, and to establish 
a start to our retirement together down near Kentucky Lake. Bob was an 
outdoorsman; he enjoyed hunting, fishing, golfing, and four-wheeler 
riding. We thought that if we were going to have to start all over then 
we would be somewhere we could enjoy retirement together.
    Bob helped raise six children of which only one was his own. When I 
met him the first (older) three children were already young adults and 
out on their own. My children were still small and he wanted to be 
``the dad that he didn't have to be.''
    He was a man that took respect very seriously; before he asked me 
to marry him, he did not ask my father for my hand in marriage, he 
respected my children enough as individuals that he asked each of them 
for permission to marry me. It says a lot about a man's character, to 
want to raise another man's children, not once, but twice, when he 
could have started living his life without children still at home.
    He was the type of man that if you needed something that he had, 
without any questions asked, it was yours. He was always trying to help 
the next person out.
    We both wound up back in the VA system after we lost private 
insurance when the Maytag plant closed. Before that, since we had the 
private insurance to pay for our health care, we opted not to use the 
facilities and benefits, in hopes this would help with the overcrowding 
of the VA; giving the next veteran a better chance at receiving the 
help and care they needed, where that might be the only option many of 
our veterans have for health care. In turn I now have reservations and 
fears of returning to the VA for my personal healthcare.
    June 26, 2007, we traveled to the Marion VA for an ultrasound of 
his entire abdomen, in which only the upper right quadrant was scanned, 
the technician found the gallbladder and didn't continue the scan on 
the rest of the abdomen; the test revealed that his gallbladder was 
full of stones and that surgery to remove the gallbladder was the 
course of action to be taken.
    I started my new job on July 26, 2007, in fear of putting my job in 
jeopardy so soon after hiring in, I was unable to attend his first 
meeting with Dr. Mendez on August 2, 2007. Bob was originally scheduled 
for surgery in September, but before he left the hospital that day 
there was a cancellation for August 9, 2007 he was asked if ``he would 
like to have that appointment instead,'' naturally in a desperate 
attempt to be relieved of his pain he accepted that earlier 
appointment. I wonder ``would he still be here today had his surgery 
not been moved up; chances are he might have even had a different 
surgeon, given the investigation that we now know would have started 
prior to the surgery being performed in September instead of August.''
    With the same fear of losing my job I ``almost'' did not accompany 
Bob to surgery that day, one of my parents was going in my place 
instead, ``Thank the good Lord above that I found the courage and 
strength to approach my new boss with my situation and ask for the time 
off that I needed for his surgery.''
    The first time I met Dr. Mendez was after Bob's surgery when he 
came to me and said ``something had gone wrong during surgery, Mr. 
Shank just wouldn't wake up, maybe he had a heart attack, maybe he had 
a stroke, I just don't know what happened; we are taking him up to ICU 
where he can be cared for, I have another patient waiting on me.''
    We left out-patient surgery and went to ICU, we were standing in 
the hallway when they wheeled my husband by, going into ICU. As they 
passed, a nurse was manually bagging him to keep him breathing; the 
next time I saw my husband as the doctor pulled me by the hand through 
a crowded room, full of nurses and doctors to his bedside. He lay there 
motionless, with tubes coming out of his body hooked to IV's and 
machines; as he was already placed on life support.
    Throughout the course of the night, I was approached by Dr. Mendez 
several times listening to him compare my husband to a ``car'' that 
needed routine check-ups and blamed my husband for not taking care of 
his body. He also at one point told me that Bob had liver damage we 
knew nothing about, and that had caused his problems. The autopsy 
performed on my husband did not reveal any liver damage (the doctor 
covering his own tracks).
    As my husband lay there with his blood pressure still dropping, 
another doctor and I questioned Dr. Mendez about taking him back into 
surgery, to find out where the blood was going; Dr. Mendez's response 
was ``I have this under control.'' He waited several hours before 
taking him back into surgery to explore where he was losing blood from. 
Standing in the hallway talking to Dr. Mendez, he told my sister and 
me, ``I have to try something, I either let him lay here and die, or I 
kill him on the operating table, but I have to try something.'' By the 
time he took him, Bob's blood pressure was so low, his blood was not 
spurting with his heart beat; it was just an ``oozing'' effect making 
it difficult for Dr. Mendez to determine where the blood was coming 
from. I believe had he gone back into surgery sooner when it was 
suggested by the other doctor, my husband would have had a better 
chance for survival.
    The autopsy revealed his bile duct had been cut and he had a 2cm 
laceration to his liver, the sutures that were placed in my husband's 
body had a knot at one end of the stitch and not at the other end. The 
heart attack and/or stroke the doctor blamed my husband's death on, was 
not supported by the autopsy either.
    As I left the hospital after my husband passed away, I had an 
overwhelming feeling that there was more to this story; something just 
didn't seem right. The nurses had a look in their eyes, that they knew 
something but just couldn't tell me what it was.
    I returned to the hospital on August 16, 2007, to sign papers for 
release of information, to obtain a copy of his medical records and 
autopsy report (to this day we still do not have a complete set of 
records). But while I was there, I saw the Chaplain, who sat and prayed 
with me through the night, and one of the nurses that took care of my 
husband in ICU, again with that same look on their faces, and in their 
eyes that told me there was more to my husband's story and they just 
couldn't tell me. Before my children and I left the hospital that day a 
hospital employee (which I had contact with shortly after Bob's 
passing) pulled me to the side, as he looked around and over our 
shoulders as if to make sure no one could over hear, he told me ``You 
need to hire an attorney, that my husband was Dr. Mendez's third 
patient death ``recently''; one of which, the man's wife worked at the 
hospital, Dr. Mendez had up and resigned from the hospital Monday 
morning and he didn't even have the decency to come to the hospital to 
resign, he sent them an e-mail instead.'' (August 13, 2007, just 3 days 
after Bob passed away). As my mouth and my heart fell to the floor I 
was shocked and instantly angry, as the pieces of the untold story were 
now falling into place; this seemed to be the coward's way out and that 
he was on the run cause he knew he had done something to Bob. In my 
mind, him fleeing was his admission of guilt as to what happened to my 
husband.
    As I look back on the day of August 9, 2007, on our drive up from 
Murray, Kentucky, to Marion, Illinois (about a two hour drive) we 
didn't discuss his operation. We were at ease knowing that he was 
finally going to get the relief from his pain that he so desperately 
needed and had waited for. We did not foresee any problems, or 
complications, and assumed he would be returning home with me the next 
day, August 10, 2007. However, he passed away that Friday morning 
instead, but finally we were able to bring him home August 16, 2007, in 
a wooden urn that now sits on top of our entertainment center. A 
picture of him cropped out of our wedding photo is overlooking his urn; 
alongside are two of his Air Force pictures placed underneath two 
trophy ducks that he had hung on the wall himself, when we moved into 
our new apartment to start living the rest of our lives together and 
looking forward to our retirement. I speak to my husband's ashes and 
picture every night before going to bed. I stand there with tears 
rolling down my face telling him how the day had gone and how much he 
missed out on each day. I always end my conversation with, ``I Love You 
and I Miss You, Goodnight My Love,'' and give him a goodnight kiss on 
the ``outdoor'' scenery of the urn, where my husband now ``Rests In 
Peace.''
    No other veteran's family should have to go through this heartache 
and pain that mine and Bob's families have to endure!!! So in closing I 
ask why my husband's life had to end this way? Why was this allowed to 
happen, given Dr. Jose Viezaga-Mendez's track record? How did the 
system fail my husband and several other veterans at the hands of this 
Doctor? How many other veterans are going to have to lose their lives 
before we, as a Country, can offer them more reliable health care?
    I want to thank you for this opportunity to have our voices heard 
and our questions answered. Although, my husband did not die during 
battle for our Country, I ultimately believe that through us he is 
still fighting for the safety of his comrades in arms and the future 
health care of our American Veterans.

                                 
          Prepared Statement of John D. Daigh, Jr., M.D., CPA,
        Assistant Inspector General for Healthcare Inspections,
    Office of Inspector General, U.S. Department of Veterans Affairs
    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to testify today on the credentialing and privileging 
process of the Department of Veterans Affairs. As a way of explaining 
to you the importance of the credentialing and privileging process, I 
would like to review our findings from the Office of Inspector General 
(OIG) report Healthcare Inspection, Quality of Care Issues, VA Medical 
Center, Marion, Illinois. I am accompanied by Dr. George Wesley, Dr. 
Andrea Buck, Dr. Jerome Herbers, and Dr. Limin Clegg.
INTRODUCTION
    The Veterans Health Administration's (VHA's) National Surgical 
Quality Improvement Program (NSQIP) identified the VA Medical Center 
(VAMC) at Marion, Illinois, as having a mortality rate that was over 
four times the expected rate as calculated by VHA during the first two 
quarters of fiscal year (FY) 2007 (October 1, 2006, through March 31, 
2007). In response, a NSQIP review team was sent to the Marion VAMC on 
August 29, 2007. By the end of its 2-day visit this team had identified 
concerns with the quality of surgical care provided patients and 
deficiencies related to medical center leadership and the Surgery 
Service, including quality management (QM) processes, such as peer 
reviews and credentialing and privileging of physicians. As a result of 
this review, inpatient surgery was suspended at the Marion VAMC, and 
the Under Secretary for Health and Congress asked the Office of 
Inspector General (OIG) to perform a comprehensive review of these 
concerns.
    The OIG Office of Healthcare Inspections (OHI) immediately 
initiated a review making numerous site visits to Marion VAMC and the 
Veteran Integrated Services Network (VISN) 15 in Kansas City, Missouri. 
We reviewed all Marion VAMC NSQIP surgical mortality cases for FY 2007 
and selected morbidity cases and ancillary services, such as 
respiratory therapy and intensive care unit capabilities, necessary to 
permit the safe performance of inpatient surgery. We retained 
distinguished surgeons and an anesthesiologist not employed by the 
Federal government to further review cases in question. We also 
conducted a comprehensive review of the credentials and privileges of 
the Marion VAMC surgical staff and a review of NSQIP processes and 
data.
    OHI staff interviewed physicians; other clinical and administrative 
staff; veterans and family members; and VHA leadership at Marion VAMC, 
VISN 15, and VA Central Office in Washington, DC. OHI also interviewed 
staff at the NSQIP Denver Data Analysis Center (DDAC), the NSQIP Boston 
Coordinating Center, and the Information Service Center at Birmingham, 
AL. Records were subpoenaed from state medical licensing boards and 
other institutions. The Federation of State Medical Boards (FSMB) was 
contacted to determine the extent of information provided VHA, as was 
the Department of Health and Human Services concerning VHA inquiries 
regarding the National Practitioner Database (NPDB).
INSPECTION FINDINGS--QUALITY OF CARE IN SELECTED CASES
    Overall, we concluded that the Surgical Specialty Care Line at 
Marion VAMC was in disarray. Based on a review of 29 deaths that 
occurred among veteran patients who underwent surgery at the Marion 
VAMC in FY 2007, we concluded that there were specific problems with 
actual quality of care provided to veteran patients. These problems 
included pre-operative, intra-operative, and post-operative quality of 
care issues. In the report we discuss three mortality cases as examples 
of those which did not meet the standard of care. A veteran suffered a 
traumatic rupture of his spleen requiring urgent surgery. Sufficient 
blood transfusions were prepared for this patient, but they were 
administered too late to be effective. The second example involved the 
care provided for a patient whose heart disease placed him at increased 
risk for surgery. This patient, who died 1 day after surgery, received 
inadequate intra- and post-operative care. The third case involved a 
death following elective gallbladder surgery, with clear evidence of 
inadequate management of the patient's ventilation and post-operative 
instability.
    OHI also identified examples of non-fatal complications resulting 
from poor care involving other patients treated by surgeons at Marion 
VAMC. In one case, we found that Marion VAMC failed to appropriately 
diagnose and treat a young Operation Iraqi Freedom Marine veteran 
following the onset of severe abdominal pain. Areas of deficiency 
related to this case included availability and use of consultants and 
the transfer of his care to his home state. He also faced substantial 
barriers to ongoing specialty care in the private sector due to the 
lack of specialty surgeons participating in TRICARE. Other cases 
discussed in this report include a veteran who received substandard 
care by an orthopedic surgeon managing a knee infection following total 
knee replacement surgery, and a urologist who perforated both the 
bladder and the sigmoid colon of another veteran patient while 
attempting to incise a urethral stricture.
    We also substantiated allegations of poor medical care involving 
two patients treated by non-surgical providers. One case involved 
allegations relating to the follow-up of a patient with a thoracic 
aortic aneurysm, and the other the medical management of a patient with 
hypotension.
QUALITY MANAGEMENT
    Quality Management is designed to monitor quality and performance 
improvement activities, compliance with selected VHA directives and 
appropriate accreditation standards, as well as Federal and local 
regulations. The ability of Marion VAMC to effectively respond to 
quality of care concerns was hampered by an ineffective QM Program. We 
found that failure to comply with VHA QM policies resulted in 
deficiencies in the peer review process, tracking and collecting 
service line or medical provider performance data, reporting adverse 
events and occurrences, and mortality assessments, among others.
    We concluded that the oversight reporting structure for QM reviews 
at Marion VAMC was fragmented and inconsistent, making it extremely 
difficult to determine the extent of oversight of patient quality or 
corrective actions taken to improve patient care. This occurred 
partially because QM responsibilities were split between multiple 
groups at the facility with little or no management oversight. 
Likewise, Surgery Service leadership was ineffective, including 
communication between the NSQIP nurse, surgical providers, and the 
Chief of Surgery, allowing multiple QM processes within the care line 
to fail.
    An important component of the QM Program is the peer review 
process. VHA defines peer review as a protected, non-punitive, medical 
center process to evaluate the care at the medical provider level. The 
peer review process includes an initial review by an individual peer to 
determine if the most experienced practitioners would have managed the 
case in a similar fashion (Level I), might have managed one or more 
aspects of the care differently (Level II), or would have managed the 
case differently (Level III) in one or more prescribed categories. At 
Marion VAMC, surgical peer review results from February 2007 through 
August 2007 resulted in 131 Level I findings, 4 level II findings, and 
no Level III findings. These results appear inconsistent with OHI 
review findings of the mortality and morbidity cases discussed in this 
report. Also, it was not clear how cases at Marion VAMC were identified 
for peer review, and cases were not presented in a timely manner. Local 
policy states that reviews should be completed in 30 days, although 
some cases took as long as 5 months.
    VHA policy requires that standardized trending of patient deaths 
occur at each medical facility. The results are required to be 
presented in a regular forum in order to identify unusual patterns or 
trends. Although VHA policy does not designate the frequency for 
presentation of death reviews, standard practice is to aggregate and 
report results quarterly. We found that Marion VAMC reviews are 
compiled annually. If there were a trend in mortality, an annual review 
would not address issues in a timely manner. For example, the latest 
review at Marion VAMC was presented in April 2007, but it was limited 
to deaths that occurred during FY 2006. As such, the spike in deaths 
reported by NSQIP that occurred during the 1st and 2nd quarters of FY 
2007 would not have been compiled and assessed for unusual patterns or 
trends until almost a year later.
    We also found that Marion VAMC had inadequate quality management 
measures in place for tracking, trending, and evaluation of data 
relating to patients undergoing cardiac catheterization. The facility 
also failed to adequately document nursing staff and provider 
competencies to perform services in the cardiac catheterization 
laboratory.
CREDENTIALING
    Credentialing refers to the process by which health care 
organizations screen and evaluate medical providers in terms of 
licensure, education, training, experience, competence, and health 
status. The credentialing process is done for a medical provider's 
initial appointment in VHA and every 2 years following. Credentialing 
occurs at the VISN 15 level in a centralized credentialing office. VISN 
15 also queries the FSMB and the NPDB to obtain information regarding 
any disciplinary actions taken against a provider's medical license and 
any paid malpractice claims. Even though credentialing is centralized 
to VISN 15, credentialing decisions must still be approved at the 
medical center by the Professional Standards Session of the Clinical 
Executive Board (Marion VAMC's term for the Professional Standards 
Board or PSB). Credentialing is done through VetPro, VA's credentialing 
and privileging system.
    We found deficiencies in the credentialing of physicians. For 
example, the PSB at Marion VAMC failed to document consideration of 
important credentialing information such as malpractice claims 
identified through the NPDB, the health status of a surgeon who 
recently had a visual problem, and information on previous performance 
problems contained in provider references. OHI also found discrepancies 
in the number of malpractice claims reflected in primary source 
documents from malpractice carriers and the initial application of a 
medical provider without evidence that this discrepancy was addressed 
by the PSB, the Chief of Staff, or the Chief of Surgery Service. Other 
examples include not completing documentation related to verification 
of licensure, registration, and board certification requirements in a 
complete and timely manner. In one instance, a physician was granted 
privileges on May 3, 2007, even though the Chief of Staff did not 
complete reporting requirements until August 27, 2007.
    VHA does not require physicians to have a medical license in the 
state in which they are employed with VA. As a result, a surgeon at 
Marion VAMC can hold a medical license issued by a state other than 
Illinois. It is also common for VA physicians to simultaneously hold 
licenses from more than one state, and to let licenses lapse and apply 
for new ones throughout their career. Being able to identify which 
state or states a physician is or has been licensed in is critical in 
obtaining information regarding any disciplinary actions taken against 
a physician's medical license for credentialing purposes. VHA currently 
has no means of identifying all states in which a physician holds a 
license to practice medicine if that physician does not disclose those 
licenses on his or her initial application.
    We found the existence of undisclosed medical licenses in both 
surgical and non-surgical providers. For example, OHI reviewed 
credentialing and privileging files for 14 non-surgical providers and 
found that 2 providers held licenses not listed on the initial 
application. In one of these examples, the medical provider had not 
disclosed a license in a state where disciplinary action was ultimately 
taken against that license. We also discovered an instance where VHA 
received a disciplinary alert from the FSMB concerning a Marion VAMC 
medical provider's license, but they failed to fully evaluate the alert 
for more than 9 months after receiving it.
PRIVILEGING
    We found significant deficiencies in the privileging of physicians, 
which is the process by which physicians are granted permissions by the 
medical center to perform various diagnostic and therapeutic 
procedures. For example, multiple instances were discovered in which 
physicians were privileged to perform procedures without any 
documentation of current competence to perform those procedures. In one 
instance, a surgeon received privileges to perform colonoscopies at the 
Marion VAMC. His privileges from his previous institution did not 
include colonoscopies. On February 22, 2006, a report of contact 
written by the Operating Room (OR) nurse manager described an incident 
in which a technologist reported to her that this surgeon had 
difficulty identifying colon anatomy and in maneuvering the 
colonoscope. We were informed that the surgeon was asked not to perform 
colonoscopies at the Marion VAMC. Although no documentation was 
identified of any action taken against his privileges, there were no 
records indicating that the surgeon performed colonoscopies after that 
date.
    In another example, we could not find documentation that the PSB 
considered current competence of a surgeon to place a central line. On 
November 1, 2007, the Acting Medical Center Director at Marion 
requested an administrative board of investigation (ABI) to examine the 
surgeon's treatment of a complication arising from central line 
placement. The physician placed a central line, and the patient, who 
was receiving mechanical ventilation at the time, developed a tension 
pneumothorax. The ABI found that, while both the surgeon and another 
physician involved in the care of the patient were privileged to 
perform needle decompression of a tension pneumothorax, neither could 
articulate the proper procedure to the ABI. The ABI recommended that 
the facility evaluate processes in place for requesting and approving 
provider privileges.
    Not only did the facility fail to document consideration of the 
current competence of a physician to perform certain procedures, the 
PSB also failed to consider professional performance data in its 
decision to re-privilege physicians at the institution. For example, as 
early as May 19, 2006, the Medical Center Director was notified of 
serious problems with documentation of patient encounters. Multiple e-
mails document that this problem was ongoing. On November 20, 2006, the 
Quality Assurance Session of the Clinical Executive Board identified 
that a specific physician had an increased number of post-operative 
infections. On April 24, 2007, the OIG referred a complaint against 
this physician to Marion VAMC for review of allegations of 
inappropriate conduct and tardiness. On June 20, 2007, Marion VAMC 
notified the OIG that an ABI substantiated multiple reports of vulgar 
language and prolonged waiting times for patients resulting from 
numerous factors, including physician tardiness. The ABI recommended 
appropriate progressive disciplinary or other administrative actions 
related to the physician's behavior. On May 10, 2007, his service chief 
received peer reviews conducted on this physician's cases which 
identified clinical care issues in 8 of 12 cases reviewed. 
Nevertheless, the physician was re-privileged without reference to 
aggregated data from the peer reviews, the results of the ABI, or the 
physician's problems with documentation.
    In part, privileging is facility specific because, regardless of 
the expertise of the physician involved, the availability of services 
at a facility may limit the appropriateness of performing those 
procedures at that facility. OHI found that facility leadership did not 
limit provider privileges based upon medical center capabilities. For 
example, the Marion VAMC Surgical Specialty Care Line Operational 
Planning Guide reflected interest in establishing a specialty surgery 
program in part to decrease fee basis costs. As a result, in January 
2006, Marion VAMC hired a general surgeon to perform surgery in that 
specialty, even though he was not board certified in general surgery or 
the specialty surgery at the time he was hired. He also received 
special pay based on the facility's recruitment and retention 
difficulties related to hiring surgeons in that specialty. Also, Marion 
VAMC did not have in-house 24-hour coverage in respiratory therapy, 
pharmacy, and radiology. Because of that, OR staff expressed concern 
about performing such complex procedures at Marion VAMC. Clinical staff 
at the facility acknowledged that they felt pressured to perform more 
complex procedures in order to reduce fee basis costs.
FACILITY LEADERSHIP
    Problems identified in the areas of quality management and 
credentialing and privileging, as well as the quality of care issues 
identified in specific cases, are a reflection of facility leadership. 
The Marion Medical Center Director, Chief of Staff, Chief of Surgery, 
Associate Chief Nurse, and Associate Director for Patient Care/Nursing 
Services have specific responsibilities for the performance of quality 
management activities in the surgical specialty care line. OHI found 
that there were significant warnings of many of these very problems 
that were available to medical center senior management well before the 
NSQIP site visit and the subsequent suspension of inpatient surgery. 
These took the form of a detailed external review of the Surgery 
Service by a consultant nurse occurring in October 2006, and a similar 
review performed by the Chief of Surgery Service of a large midwestern 
VAMC. Likewise, we found internal reports of contact and e-mails 
detailing frontline nursing surgical staff problems with many aspects 
of the Surgery Service. It appears that most of this information, with 
the possible exception of the aforementioned Chief of Surgery Service's 
report, was not disseminated to other VHA managerial entities such as 
VISN 15 or VA headquarters in Washington, DC.
NATIONAL SURGICAL QUALITY IMPROVEMENT PROGRAM
    NSQIP data are collected locally at each VAMC and analyzed 
centrally in the DDAC. The Marion VAMC NSQIP data were abstracted and 
entered by the same NSQIP Surgical Clinical Nurse Reviewer (SCNR) for 
the 1st and 2nd quarters of FY 2007, during which the Marion VAMC had 
elevated Observed-to-Expected mortality ratios which triggered the 
NSQIP team site visit. During her tenure as the Marion SCNR from 
September 1998 until her retirement in April 2007, there is no evidence 
to question her technical competence as the NSQIP SCNR.
    We concluded that NSQIP offers an opportunity of providing 
evidence-based monitoring and improvement in VA quality of surgical 
care. NSQIP could improve by developing an operations manual for the 
DDAC, reviewing and adopting the state-of-the-art statistical 
methodologies, detailing its risk-adjustment methodology in a technical 
report, taking more advantage of the VA computerized medical records 
system in its data collection and edits, and evaluating evidence of its 
tangible improvement in VA quality of surgical care. NSQIP would 
enhance the utility of its risk-adjusted and unadjusted surgical 
outcome measures by taking its sampling scheme into account in their 
estimation to reflect the actual outcome experience of the VA surgical 
patient population.
RECOMMENDATIONS
    The following recommendations are based on the findings of the 
report.

    Recommendation 1: The Under Secretary for Health develop and 
implement a national quality management directive that ensures a 
standardized structure and mechanism throughout VHA for collecting and 
reporting quality management data.
    Recommendation 2: The Under Secretary for Health develop and 
implement a mechanism to ensure that VHA's diagnostic and therapeutic 
interventions are appropriate to the capabilities of the medical 
facility.
    Recommendation 3: The Under Secretary for Health explore the 
feasibility of implementing a process to independently identify all 
state licenses for VA physicians.
    Recommendation 4: The Under Secretary for Health develop and 
implement formal policies and procedures to ensure that Federation of 
State Medical Boards' Disciplinary Alerts are timely addressed by 
medical facilities, VISNs, and VHA headquarters.
    Recommendation 5: The Under Secretary for Health conduct reviews to 
determine appropriate administrative actions against Marion VAMC 
leadership and other staff responsible for the problems cited in this 
report, to include the Medical Center Director, the Chief of Staff, the 
Chief of Surgery, the Associate Director for Patient Care/Nursing 
Services, and the Associate Chief Nurse of the Surgical Service.
    Recommendation 6: The Under Secretary for Health issue guidance 
that clearly defines what constitutes evidence of current competence 
for use in the privileging process.
    Recommendation 7: The Under Secretary for Health consider the 
issues which are identified in this report for modifications to NSQIP 
and other related programs.
    Recommendation 8: The Under Secretary for Health confer with the 
Office of General Counsel regarding the advisability of informing 
families of patients discussed in this report about their right to file 
tort and benefit claims.
    Recommendation 9: The Under Secretary for Health ensure that Marion 
VAMC complies with VHA policies regarding peer review, mortality 
assessments, adverse event reporting, and the performance of root cause 
analyses.
    Recommendation 10: The Under Secretary for Health require the 
Professional Standards Session of the Clinical Executive Board at 
Marion VAMC to consider National Practitioner Database results and 
document consideration of those results.
    Recommendation 11: The Under Secretary for Health ensure that 
Marion VAMC appropriately credentials providers with references 
executed in accordance with VHA Handbook 1100.19 and documents 
consideration of discrepancies in provider disclosures and information 
obtained from references.
    Recommendation 12: The Under Secretary for Health require the 
Marion VAMC Chief of Surgery, Chief of Staff, and Professional 
Standards Session of the Clinical Executive Board to consider the 
health status of practitioners for credentialing and privileging 
purposes in accordance with VHA Handbook 1100.19.
    Recommendation 13: The Under Secretary for Health require the 
Marion VAMC Chief of Staff to sign and complete the certification 
correctly on VA Form 10-2850, Application for Physicians, Dentists, 
Podiatrists and Optometrists.
    Recommendation 14: The Under Secretary for Health require the 
Professional Standards Session of the Clinical Executive Board at 
Marion VAMC to consider and resolve discrepancies in the number of 
malpractice claims disclosed by a practitioner and the number obtained 
through primary source verification.
    Recommendation 15: The Under Secretary for Health require that the 
Marion VAMC Chief of Surgery Service and the Professional Standards 
Session of the Clinical Executive Board record the documents reviewed 
and rationale for the conclusions reached with respect to privileging 
process.
    Recommendation 16: The Under Secretary for Health require that the 
Marion VAMC Chief of Surgery, Chief of Staff, and Professional 
Standards Session of the Clinical Executive Board document 
consideration of quality assurance data in accordance with VHA Handbook 
1100.19 in the re-privileging of medical providers.
    Recommendation 17: The Under Secretary for Health ensure that the 
new cardiac catheterization laboratory at Marion VAMC fully institutes 
quality management measures, performs appropriate competency 
evaluations for staff, and evaluates the privileging of catheterization 
laboratory providers in according with VHA policy.
Comments
    The Under Secretary for Health concurred with our findings and 
recommendations and submitted appropriate action plans. We found the 
Department's improvement plans acceptable and will follow up until all 
recommendations are implemented.
    Mr. Chairman, thank you again for the opportunity to testify on 
this important issue. We would be pleased to answer any questions that 
you or other members of the Committee may have.

                                 
          Prepared Statement of Gerald M. Cross, M.D., FAAFP,
              Principal Deputy Under Secretary for Health,
  Veterans Health Administration, U.S. Department of Veterans Affairs
    Good morning, Mr. Chairman and members of the Subcommittee. Thank 
you for the opportunity to discuss the reports from VA's Office of the 
Inspector General (OIG) and the Office of the Medical Inspector (OMI) 
regarding surgical care provided at the Marion, IL VA Medical Center 
(VAMC). I am accompanied by Ms. Kate Enchelmayer, Director of Quality 
Standards, Dr. John Pierce, Veterans Health Administration (VHA) 
Medical Inspector, Nevin Weaver, VHA's Director of Workforce Management 
and Consulting, and Paul Hutter, VA's General Counsel. These reports 
were issued yesterday and I understand the Committee has already 
received them. As the Committee members know, these investigations 
yielded troubling news.
    Last year, VA provided treatment to almost 5.5 million veterans, 
the vast majority of whom received exemplary care. The events at Marion 
represent an unfortunate exception to our established record of high 
quality care. As part of that care, the VA review process detected the 
problems at Marion, and our response has been sure and swift. Our 
Department is committed to continually improving our care to make the 
VA health care system a model of excellence for health care around the 
world. VA is determined to do the right thing for our patients and 
their families.
    In that spirit, I will now outline VA's initial response to the 
problems VA identified at Marion, the conclusions of the two 
independent investigations, and our subsequent actions.
    The Marion VAMC opened in 1942 and now provides care to almost 
44,000 veterans annually. The Marion VAMC serves 27 counties in 
southern Illinois, eight counties in southwestern Indiana, and 17 
counties in northwest Kentucky. It is a general medical and surgical 
hospital that operates 55 acute care beds. The last full survey by the 
Joint Commission was completed on August 31, 2007. There were no major 
issues identified, and the Marion VAMC was re-accredited.
    The National Surgical Quality Improvement Program (NSQIP) gathers 
aggregate data from surgical outcomes to determine whether there are 
significant deviations in mortality and morbidity rates for surgical 
procedures. VA developed NSQIP almost 15 years ago as part of our 
effort to monitor and improve the quality of surgical care. The 
American College of Surgeons (ACS) has incorporated its own version and 
now enrolls new private sector hospitals in the ACS' program. VA's 
NSQIP feeds back mortality and morbidity data on a quarterly basis to 
VA Surgical Chiefs, Directors, and VISN CMO's. Beginning in Fiscal Year 
2007, the National Director of Surgery of the NSQIP Executive Committee 
reviews NSQIP information on a quarterly basis. Prior to that time, the 
information had been reviewed by the board yearly. It was decided that 
NSQIP would be a better tool if the data were acted upon more 
frequently. This was reinforced when our NSQIP data was evaluated after 
the onset of this new timing.
    For Fiscal Year 2006 (FY06), there were fewer surgery-related 
deaths at Marion VAMC than statistically predicted by NSQIP, suggesting 
surgical performance was acceptable. Questions about the quality of 
care at Marion first arose in April 2007, when NSQIP data became 
available to facility leadership at Marion for the first quarter of 
Fiscal Year 2007 (FY07). The data revealed the number of deaths during 
and after surgery between October and December 2006 were significantly 
higher than NSQIP statistically expected.
    On April 26, 2007 the 1st Quarter FY07 data became available to the 
facility's parent organization, the VA Heartland Network Office in St. 
Louis (VISN 15). In early May, the Network's Chief Medical Officer 
discussed the data with the Marion director, who agreed to review the 
data by asking Marion surgeons to conduct additional internal peer 
reviews. On May 22, the director provided the Chief Medical Officer 
with the results of the peer reviews conducted by the hospital, which 
concluded surgical performance was acceptable.
    In July 2007, the Network and the facility received NSQIP results 
from the second quarter of FY07, indicating there had been two 
additional reportable deaths between January 1 and March 31. On August 
10, the Network learned of four more surgery-related deaths and one of 
the hospital's three general surgeons notified the Director he intended 
to resign. The Network initiated additional peer reviews, this time by 
VA physicians from outside the facility. In addition, they notified the 
NSQIP Executive Committee.
    On August 15, 2007 the VA NSQIP Executive Committee told Marion 
they would conduct an urgent site visit. As a result of the findings of 
their August 29 and 30 visit, NSQIP's Executive Committee recommended 
suspending major surgeries at the hospital, pending a more 
comprehensive investigation; the facility director agreed. After NSQIP 
verbally briefed the Under Secretary for Health, he immediately 
directed the Office of the Medical Inspector to investigate the 
situation at Marion.
    The Medical Inspector's initial investigation took place on 
September 5 and 6, and he briefed the Under Secretary on September 10. 
The Medical Inspector recommended continuing the suspension of major 
surgeries, due to serious concerns regarding the facility's surgical 
care capabilities. On the same day, the Under Secretary also requested 
the Medical Inspector continue its review and asked the Inspector 
General to begin an independent investigation of its own. VA briefed 
the staffs of the House and Senate Veterans' Affairs Committees on the 
Medical Inspector's findings on September 13.
    On September 14, a new leadership team took charge of Marion. The 
Under Secretary reassigned the Hospital Director and Chief of Staff to 
non-supervisory, restricted one Mortality Reportable deaths: All deaths 
within 30 days including preoperative, intraoperative and other 
postoperative occurrences prior to death. (American College of 
Surgeons: National Surgical Quality Improvement Program) administrative 
duties outside the hospital and placed the Chief of Surgery and an 
anesthesiologist on administrative leave.
    The reports of the Inspector General and the Medical Inspector 
agree that surgical patients were harmed because patients received 
substandard care at the Marion VAMC. According to the Medical 
Inspector, out of 7,949 procedures conducted over a period of two 
years, nine surgical patients died as a result of substandard care. 
Thirty-four additional patients who had a procedure also received 
substandard care, which complicated their health issues; while ten of 
these surgical patients died, the Medical Inspector did not determine 
that substandard care caused their deaths.
    In parallel with the completion of the reports by the Inspector 
General and the Medical Inspector, VA has conducted checks on the 
credentials of every member of the hospital's medical staff. One 
surgeon failed to disclose a previous license and was fired. VA learned 
about this license, as well as an action against it, during a re-
privileging review. The anesthesiologist placed on administrative leave 
has since resigned. VA has alerted the appropriate licensing 
authorities about the anesthesiologist and the surgeon who resigned in 
August. The surgeon who was fired in January is still within a 30-day 
appeal period, so VA is unable to make a report until that time has 
expired. Investigators examined the quality-management program and 
other concerns raised by employees regarding human resources, labor 
relations, and the environment of care.
    Both the Inspector General and the Medical Inspector identified the 
same four areas as contributing factors to the decline in Marion's 
quality of care: facility leadership, quality management, privileging, 
and credentialing.
    The Inspector General concluded significant warning signs were 
available such that the leadership of the Marion VAMC should have 
recognized them and intervened before others discovered these problems. 
According to the Inspector General, much of this information was not 
disseminated to other VHA managerial entities, including the Network 
Office in St. Louis or Central Office in Washington, D.C.
    Both reports found that reviews of the quality of care, including 
the facility's peer reviews, were not complete and thorough. 
Additionally, trends in patient deaths at the hospital, which VA 
requires all medical centers to monitor, were not adequately evaluated, 
preventing the facility from properly addressing these problems in a 
timely manner.
    VA requires that its physicians be credentialed and privileged 
regularly. This information is verified through the National 
Practitioner Data Bank, other databases, and additional sources 
containing information on disciplinary actions taken against a 
physician's state medical license or a physician's competence.
    VA physicians must complete a written request for clinical 
privileges for review by their supervisor, who considers whether the 
physician possesses the appropriate professional credentials, training, 
and work experience to successfully perform the procedures for which 
they have requested privileges. Every two years, or more frequently if 
circumstances dictate, supervisors are required to review information 
on each physician's performance, including surgical complication rates, 
and to decide whether or not to renew a physician's clinical 
privileges.
    Both the Inspector General and the Medical Inspector found cases 
where surgeons performed procedures with little or no documentation of 
their competence. When granting privileges, supervisors did not conduct 
full evaluations; rather, they relied on privileges granted by a 
previous, non-VA facility without adequately considering objective 
measures of past performance and outcomes.
    These reports also criticized the facility for permitting surgeries 
more complex than the facility could accommodate based on its staff and 
capabilities. There was not adequate staff coverage in areas critical 
to managing surgical complications, including respiratory therapy, 
pharmacy, and radiology.
    Staff at the Marion facility also failed to pursue adequately 
questions regarding one surgeon's credentials that arose after the 
surgeon was hired. This information became available through an alert 
from the Federation of State Medical Boards.
    VA is closely examining each of these areas, not only at Marion but 
throughout the Department's health care system, to ensure no other 
facilities share these issues and to prevent them from developing 
anywhere else. We assembled a work group to review the process by which 
peer reviews are handled within the Department. Yesterday, the Under 
Secretary signed a new directive setting forth new requirements on the 
manner in which physicians will conduct peer reviews at all facilities 
while calling for external and independent reviews when appropriate.
    Similarly, we are reviewing our credentialing and privileging 
processes, and will increase our vigilance to ensure the information 
provided by our physicians is valid and complete. Yesterday, VA 
initiated an Administrative Board of Investigation to review quality of 
care issues and the conduct of individual employees at Marion. The 
Board will consist of senior VA employees from other facilities and 
networks: three physicians, two human resource specialists, and an 
information technology expert. The Board is empowered to recommend 
specific disciplinary actions against individuals. For now, VA is 
continuing its suspension of major surgeries at Marion.
    It is important to note the Inspector General's and the Medical 
Inspector's reports are based on external peer reviews of the written 
records of surgical cases in the Department. The staff at Marion has 
not yet had the opportunity to provide information, but they will be 
given this opportunity by the Administrative Board.
    VA has begun notifying all patients and family members of patients 
who we believe may have been harmed by the events at the Marion VAMC. 
We will provide them a thorough and honest assessment of their care, 
and will offer follow-up assistance as appropriate. We will also help 
them develop and file, as appropriate, any claims they may have related 
to improper or insufficient care at the Marion VAMC. A toll-free number 
has been established for those with questions about the notification 
process. Marion patients requiring surgery will, as appropriate, either 
be transferred to the St. Louis VA Medical Center or, if St. Louis does 
not have the capacity or the patient cannot travel, VA will contract 
for care in the community.
    Let me close with VA's sincere apologies to all who received 
substandard care at Marion, to their loved ones, to the Marion 
community, and to all of America's veterans and their families. We 
understand our unique role in upholding two sacred trusts--physicians' 
responsibility to instill confidence in their patients and provide the 
best care possible; and our Nation's duty to honor and care for those 
who have served so nobly to defend it. We are determined not only to 
correct the problems we have uncovered, but to make Marion and all our 
facilities a model for health care excellence across the country and 
the world.
    Thank you again for the opportunity to appear here today.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 

                                     Committee on Veterans' Affairs
                                                    Washington, DC.
                                                 September 14, 2007

Honorable George Opfer
Inspector General
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Mr. Opfer:

    We would like to request that the Office of Inspector General of 
the U.S. Department of Veterans Affairs (VA) conduct an investigation 
on surgical deaths at the Marion, Illinois VA Medical Center over the 
past year.
    The investigation should include a complete review of the National 
Surgery Quality Improvement Program data from the facility, all 
corrective actions taken in response to the surgical deaths at the 
facility and by the VISN, including the response from the Mortality and 
Morbidity Committee meetings. Additionally, we would like to request 
that the IG include an audit on the credentials and privileges of the 
surgical staff at the Marion VA Medical Center.
    If you have any questions, please contact the Subcommittee on 
Oversight and Investigation's Republican Staff Director, Arthur K. Wu, 
at (202) 225-3527.

            Sincerely,
                                                        STEVE BUYER
                                                     Ranking Member

                                                  GINNY BROWN-WAITE
                                                     Ranking Member

                                 

                                     Committee on Veterans' Affairs
                                                    Washington, DC.
                                                   January 30, 2008

Hon. James B. Peake
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Secretary Peake:

    Yesterday, Dr. Gerald Cross testified that the VA is taking a 
number of steps to comply with the seventeen VA Office of Inspector 
General's recommendations made in their January 28, 2008 report, 
Healthcare Inspection: Quality of Care Issues, VA Medical Center, 
Marion, Illinois (Report No. 07-03386-65), and to respond more 
generally to the issues brought to light by the tragic events at the 
Marion, Illinois VA Medical Center.
    We request that by February 8, 2008, this Subcommittee be provided 
with an itemized schedule with definitive implementation and completion 
dates. If the timing of your response is a problem, or you have any 
other questions, please contact Geoffrey Bestor, Esq., Staff Director, 
Subcommittee on Oversight and Investigations at (202) 225-3569; or 
Arthur Wu, Republican Staff Director, at (202) 225-3527.
    We look forward to reading your timeline. In advance, thank you.

            Sincerely,
                                                  HARRY E. MITCHELL
                                                           Chairman

                                                  GINNY BROWN-WAITE
                                          Ranking Republican Member
                               __________
   Healthcare Inspection: Quality of Care Issues, VA Medical Center, 
               Marion, Illinois (Report No. 07-03386-65)
                               APPENDIX A
Department of Veterans Affairs
Memorandum
Date: January 23, 2008
From: Under Secretary for Health (10)
Subj: OIG Draft Report, Healthcare Inspection, Quality of Care Issues, 
    VA Medical Center, Marion, Illinois

To: Assistant Inspector General for Healthcare Inspections (54)

    1. I have reviewed the draft report and I concur with your 
recommendations. The findings outlined in your review, and the lack of 
appropriate and timely management intervention to address the situation 
are disturbing. Let me assure you that I am personally committed to 
ensuring that the recommendations made in this report are implemented 
as swiftly as possible and that the circumstances that allowed these 
events to unfold are prevented from recurring at this facility, or any 
other VHA facility.
    2. As outlined in the attached action plan, VHA is taking a number 
of steps to strengthen its surgical programs, monitoring and oversight, 
which will allow identification of potential problems much sooner than 
we can now, and will strengthen our surgical programs and service to 
veterans. VHA is revising its peer review policies with the intention 
that it will serve as a benchmark for peer review in the United States. 
VHA is also revising its credentialing and privileging policies and 
training to ensure that the issues identified at Marion do not occur at 
any of VHA's facilities. I have directed the review of leadership and 
other staff responsible for these events and will take appropriate 
action once the reviews are completed. VHA will also provide assistance 
and information, in conjunction with VA's General Counsel, to those 
patients and/or their representatives involved in these adverse events.
    3. In summary, VHA takes what has occurred very seriously and I 
regret these unfortunate events. Your assistance in helping to identify 
the issues is appreciated. I assure you that needed improvements are 
being implemented, with careful monitoring by both Network and VACO 
program officials, who will keep my office fully apprised of progress.

                                   Michael J. Kussman, MD, MS, MACP

Attachment
                               __________
                     VETERANS HEALTH ADMINISTRATION
                          Action Plan Response
   OIG Draft Report, Health Ccare Inspection, Quality of Care Issues,
         VAMC Marion, IL, Draft Report, Dated January 16, 2007
OIG Recommendations
    Recommendation 1: The Under Secretary for Health develop and 
implement a national quality management directive that ensures a 
standardized structure and mechanism throughout VHA for collecting and 
reporting quality management data.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                                   May 2008
----------------------------------------------------------------------------------------------------------------


    VHA will form a work group to make recommendations about the 
structure and processes for the collection, analysis, management and 
reporting of quality management data into VHA policy. OIG will be 
invited to brief the workgroup about their findings and their 
recommendations related to this item.
    VHA is in the process of formalizing an Integrated Risk Management 
Program. Implementation of the Risk Management Program will depend upon 
the recommendations of the workgroup report.
    Although the current peer review policy exceeds national standards, 
VHA has recently revised its directive on Peer Review for Quality 
Management. Our intention is that this new policy will serve as the 
benchmark for peer review in the United States.

    Recommendation 2: The Under Secretary for Health develop and 
implement a mechanism to ensure that VHA's diagnostic and therapeutic 
interventions are appropriate to the capabilities of the medical 
facility.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                                  July 2008
----------------------------------------------------------------------------------------------------------------


    As surgical procedures and peri-operative care become more complex, 
it is increasingly important to understand the nature, and to qualify 
and quantify the extent, of processes and personnel involved in the 
pre-operative assessment, the operative intervention, and the post-
operative care of the surgical patient. It is essential to match the 
complexity of a procedure, the skills of the surgeon, and the extent of 
peri-operative support.
    To understand and quantify, to the degree possible, those complex 
systems interactions, the Under Secretary for Health chartered an 
Operative Complexity and Infrastructure Standards Workgroup in December 
2007. This workgroup has been tasked with the following key 
deliverables: 1) Identify a structure with which to define the 
complexity of surgical procedures/interventions, 2) Identify and 
categorize the elements (infrastructure) involved in peri-operative 
care, 3) Develop a matrix model to correlate level of peri-operative 
services with complexity of procedures to be performed, 3) Identify 
plan for quality management/monitoring, and 4) Identify strategies and 
action plans for roll out.

    Recommendation 3: The Under Secretary for Health should explore the 
feasibility of implementing a process to independently identify all 
state licenses for VA physicians.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                                 March 2008
----------------------------------------------------------------------------------------------------------------


    We recognize that this is a national problem for VA, DoD, IHS, PHS 
and all U.S. healthcare organizations and VHA will explore the 
feasibility of implementing a process. VA policy requires practitioners 
to report all current and previously held licenses at the time of 
initial appointment and keep the agency apprised of anything that would 
adversely affect or otherwise limit their clinical privileges. Failure 
to do so may result in administrative action. Additionally, all 
practitioners are required to account for their personal history from 
the time of graduation. Staff must look at this personal history and 
discern if there is potential for the practitioner to have a license 
that is not declared during the application process. Medical staff 
credentialers and leadership will have this process reinforced by 
Office of Quality and Performance staff and VHA will continue to look 
for solutions to this issue.

    Recommendation 4: The Under Secretary for Health develop and 
implement formal policies and procedures to ensure that Federation of 
State Medical Boards' Disciplinary Alerts are timely addressed by 
medical facilities, VISNs, and VHA headquarters.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                                 April 2008
----------------------------------------------------------------------------------------------------------------


    VHA has already incorporated language into VHA Handbook 1100.19, 
Credentialing and Privileging (currently in concurrence) requiring VA 
medical center staff notified of a Disciplinary Alert from the 
Federation of State Medical Boards as follows: Facility credentialing 
staff must obtain primary source information from the State licensing 
board for all actions related to the disciplinary alert. Complete 
documentation of this action, including the practitioner's statement, 
is to be scanned into VetPro before filing in the paper credentials 
file. Medical staff leadership is to review all documentation to 
determine the impact on the practitioner's continued ability to 
practice within the scope of privileges granted. This review must be 
completed within 30 days of the notice to the facility staff of the 
alert and complete documentation in VetPro prior to filing in the paper 
file. This process will be coordinated and monitored by staff from the 
Office of Quality and Performance. Failure to complete these actions 
within 30 days will be reported to the VISN Chief Medical Officer. 
Compliance with this policy will be assessed through the System-wide 
Ongoing Assessment and Review Strategy (SOARS) process.

    Recommendation 5: The Under Secretary for Health conduct reviews to 
determine appropriate administrative actions against Marion VAMC 
leadership and other staff responsible for the problems cited in this 
report, to include the Medical Center Director, the Chief of Staff, the 
Chief of Surgery, the Associate Director for Patient Care/Nursing 
Services, and the Associate Chief Nurse of the Surgical Service.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                         Estimated May 2008
----------------------------------------------------------------------------------------------------------------


    An Administrative Investigation Board (AIB) has been charged to 
investigate problems cited and issues raised at the VA Medical Center 
in Marion, IL and to recommend appropriate administrative actions on 
their findings. The AIB will begin the investigation the week of 
January 28, 2008.

    Recommendation 6: The Under Secretary for Health issue guidance 
that clearly defines what constitutes evidence of current competence 
for use in the privileging process.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                                  July 2008
----------------------------------------------------------------------------------------------------------------


    The 2008 Joint Commission Standards require each facility to define 
a Focused Provider Practice evaluation for new practitioners and new 
privileges requested by practitioners at their facility. Additionally, 
VHA's Health Care Failure Mode and Effects Analysis (HFMEA) Team has 
recommended the development of indicators to be used by facilities in 
defining provider profiles for ongoing monitoring of clinical 
competence. These will be specialty specific and developed by the 
appropriate clinical champions based on current medical evidence and 
national benchmarks and incorporated into the Provider Profile Library 
on the Office of Quality and Performance Web site. These provider 
profiles will be developed in conjunction with Patient Care Services. 
Priority in development of these profiles will be given to General 
Surgery. In the interim, the DUSHOM will direct the field that any 
renewal or augmentation of clinical privileges will be carefully 
reviewed. DUSHOM action will be followed by publication of a directive 
developed by the Office of Quality and Performance.

    Recommendation 7: The Under Secretary for Health consider the 
issues which are identified in this report for modifications to NSQIP 
and other related programs.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process                             September 2008
----------------------------------------------------------------------------------------------------------------


    NSQIP is a nationally recognized surgical quality program designed 
to enhance the outcomes and efficiency of surgical and peri-operative 
care across the continuum of the episode of surgical care, beginning 
with the initial evaluation for a possible surgical problem and ending 
with long-term outcomes of surgery. NSQIP provides reliable and valid 
data on the processes, organizational attributes, outcomes, and costs 
of care at the patient or facility-level. These data are then 
aggregated, analyzed, and transformed into information.
    The NSQIP has been successful in achieving this mission through 
enhancements to the ongoing collection, analysis, and dissemination of 
reliable and valid information about the outcomes, processes, 
organizational attributes, costs, and appropriateness of surgical and 
peri-operative care. In 2001, the American College of Surgeons (ACS) 
began to take an active interest in the NSQIP and its results in 
reducing surgical mortality and morbidity rates. Based on the success 
of the pilot program, and in collaboration with the VA, the ACS applied 
for an Agency for Healthcare Research and Quality (AHRQ) grant to 
expand the program further into the private sector.
    As surgical care and its associated challenges evolve, VHA will 
remain a leader in the field of surgical quality and safety. New 
strategies and goals are being developed to anticipate ongoing changes 
in surgical health care delivery. To that end, the Under Secretary for 
Health will launch a Surgical Quality Workgroup on January 17, 2008. 
This workgroup will be tasked with the following key deliverables:

      Assess current strategies for surgical quality 
improvement, including but not limited to, a review, comparison, and 
contrast of the current NSQIP model, Continuous Improvement in Cardiac 
Surgical Program (CICSP) and Neurosurgery Consultants Board processes.
      Employ state-of-the-art statistical methodologies to 
evaluate current processes of sampling, imputation modeling and risk 
adjustment models to determine if there are any opportunities for 
improvement in current analysis methodologies that will further refine 
the success of the NSQIP program.
      Develop metrics/processes to enhance granular assessments 
of surgical program quality to supplement aggregated, risk-adjusted 
data.
      Define a core quality assessment process that each 
facility can use to assess ongoing quality on as `close to real time' 
process as possible modeling and risk adjustment models to determine if 
there are any opportunities for improvement in current analysis 
methodologies that will further refine the success of the NSQIP 
program.

    The work done by this workgroup will be in alignment with the 
findings of the Operative Complexity and Infrastructure Standards 
Workgroup.
    The Under Secretary of Health will also charge the Surgery Program 
Office in the Office of Patient Care Services to develop a NSQIP 
operations manual that defines processes of data collection, sampling 
methodology and analysis methodologies,
    Other related programs identified in the report refer to the 
Cardiac Catheterization Laboratory. VHA has a Cardiovascular 
Assessment, Reporting and Tracking System for Catheterization 
Laboratories (CART-CL) program. The mission of the CART-CL project is 
to develop and implement a national VA reporting system, data 
repository, and quality improvement program for procedures performed in 
VA cardiac catheterization laboratories. This program provides for a 
standardized data capture and reporting process across all VA 
catheterization labs, is a single national data repository for tracking 
and documenting cardiac procedures performed in VA cardiac 
catheterization labs, has core data elements that conform to the 
definitions and standards of the American College of Cardiology's 
National Cardiovascular Data Registry (ACC-NCDR) to allow for 
benchmarking, and it provides a centralized platform to support quality 
improvement, both locally and nationally and will allow for VA 
participation in the ACC-NCDR quality improvement program. The CART-CL 
project was initiated in 2003 with, after development and testing, a 
phased in implementation process that began in 2006. All facilities 
with cardiac catheterization labs will be fully on board by the end of 
2008 (currently approximately 99% are installed). Local site reports 
have been developed that outline utilization and volume of cases in the 
labs. Now, with increased volume of cases and that soon all 
laboratories will be installed, the next phase of reporting will add 
quality indicators that will include benchmarking from the ACC-NCDR 
registry.

    Recommendation 8: The Under Secretary for Health confer with the 
Office of General Counsel regarding the advisability of informing 
families of patients discussed in this report about their right to file 
tort and benefit claims.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                    In process   Initiated immediately, completed as soon
                                                                         as possible but not later than 1 month
                                                                                from publication of the report.
----------------------------------------------------------------------------------------------------------------


    Consistent with VHA Directive 2005-049, Disclosure of Adverse 
Events to Patients, institutional leaders at the Marion VAMC will 
review information, from the patients' medical records and subsequent 
findings in the report of the Office of the Inspector General, with 
patients or their representatives. In addition, patients and/or their 
representatives will be provided information regarding how to request 
compensation. Representatives from the VA's Regional Counsel will be 
ready to assist with this process. VHA institutional leaders will also 
apologize as part of communicating with patients and/or their families 
regarding these adverse events.

    Recommendation 9: The Under Secretary for Health ensure that Marion 
VAMC complies with VHA policies regarding peer review, mortality 
assessments, adverse event reporting, and the performance of root cause 
analyses.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
provide comprehensive training to ensure Marion VAMC complies with VHA 
policies regarding peer review, mortality assessments, adverse event 
reporting, and the performance of root cause analyses. Network 
leadership will report to the DUSHOM when Marion VAMC is compliant with 
these VHA policies.

    Recommendation 10: The Under Secretary for Health require the 
Professional Standards Session of the Clinical Executive Board at 
Marion VAMC to consider National Practitioner Database results and 
document consideration of those results.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring of the 
Chief Medical Officer and Quality Management Officer, will require the 
Professional Standards Session of the Clinical Executive Board at 
Marion VAMC to utilize National Practitioner Database results and 
document evaluation of results. Network leadership will report to the 
DUSHOM when the Marion VAMC is compliant with this recommendation.

    Recommendation 11: The Under Secretary for Health ensure that 
Marion VAMC appropriately credentials providers with references 
executed in accordance with VHA Handbook 1100.19 and documents 
consideration of discrepancies in provider disclosures and information 
obtained from references.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require that Marion VAMC staff appropriately credential providers with 
references executed in accordance with VHA Handbook 1100.19 and 
document evaluation of references in provider disclosures and 
information obtained from references. Network leadership will report to 
the DUSHOM when the Marion VAMC is compliant with this recommendation.

    Recommendation 12: The Under Secretary for Health require the 
Marion VAMC Chief of Surgery, Chief of Staff and Professional Standards 
Session of the Clinical Executive Board to consider the health status 
of practitioners for credentialing and privileging purposes in 
accordance with VHA Handbook 1100.19.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require the Professional Standards Session of the Clinical Executive 
Board to consider and document the health status of practitioners for 
credentialing and privileging purposes in accordance with VHA Handbook 
1100.19. Network leadership will report to the DUSHOM when the Marion 
VAMC is compliant with this recommendation.

    Recommendation 13: The Under Secretary for Health require the 
Marion VAMC Chief of Staff to sign and complete the certification 
correctly on VA Form 10-2850, Application for Physicians, Dentists, 
Podiatrists and Optometrists.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                              February 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require the Marion VAMC Chief of Staff sign and complete the 
certification correctly on VA Form 10-2850, Application for Physicians, 
Dentists, Podiatrists and Optometrists. Network leadership will report 
to the DUSHOM when the Marion VAMC is compliant with this 
recommendation.

    Recommendation 14: The Under Secretary for Health require the 
Professional Standards Session of the Clinical Executive Board at 
Marion VAMC to consider and resolve discrepancies in the number of 
malpractice claims disclosed by a practitioner and the number obtained 
through primary source verification.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require the Professional Standards Session of the Clinical Executive 
Board at Marion VAMC consider and resolve discrepancies in the number 
of malpractice claims disclosed by a practitioner and the number 
obtained through primary source verification. This resolution must be 
documented. Network leadership will report to the DUSHOM when the 
Marion VAMC is compliant with this recommendation.

    Recommendation 15: The Under Secretary for Health require that the 
Marion VAMC Chief of Surgery Service and the Professional Standards 
Session of the Clinical Executive Board record the documents reviewed 
and rationale for the conclusions reached with respect to the 
privileging process.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require that the Marion VAMC Chief of Surgery Service and the 
Professional Standards Session of the Clinical Executive Board record 
the documents reviewed, with a rationale for the conclusions reached 
with respect to the privileging process. Network leadership will report 
to the DUSHOM when the Marion VAMC is compliant with this 
recommendation.

    Recommendation 16: The Under Secretary for Health require that the 
Marion VAMC Chief of Surgery Service, Chief of Staff, and the 
Professional Standards Session of the Clinical Executive Board document 
consideration of quality assurance data in accordance with VHA Handbook 
1100.19 in the re-privileging of medical providers.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 March 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require that the Marion VAMC Chief of Surgery Service, Chief of Staff, 
and the Professional Standards Session of the Clinical Executive Board 
document consideration of quality assurance data in accordance with VHA 
Handbook 1100.19 in the re-privileging of medical providers. Network 
leadership will report to the DUSHOM when the Marion VAMC is compliant 
with this recommendation.

    Recommendation 17: The Under Secretary for Health ensure that the 
new cardiac catheterization laboratory at Marion VAMC fully institutes 
quality management measures, performs appropriate competency 
evaluations for staff, and evaluates the privileging of catheterization 
laboratory providers in accordance with VHA policy.


----------------------------------------------------------------------------------------------------------------
                Recommendations/Actions                     Status                  Completion Date
----------------------------------------------------------------------------------------------------------------
Concur                                                       Planned                                 April 2008
----------------------------------------------------------------------------------------------------------------


    VHA, through network leadership oversight and monitoring, will 
require that the new cardiac catheterization laboratory at Marion VAMC 
fully institutes quality management measures, performs appropriate 
competing evaluations for staff, and evaluates the privileging of 
catheterization laboratory providers in accordance with VHA policy. 
Network leadership will report to the DUSHOM when the Marion VAMC is 
compliant with this recommendation.

                                 

                                     Committee on Veterans' Affairs
                       Subcommittee on Oversight and Investigations
                                                    Washington, DC.
                                                  February 28, 2008

Hon. George J. Opfer
Inspector General
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Mr. Opfer:

    On Tuesday, January 29, 2008, the Subcommittee on Oversight and 
Investigations of the House Committee on Veterans' Affairs held a 
hearing on credentialing and privileging systems at the U.S. Department 
of Veterans Affairs (VA).
    During the hearing, the Subcommittees heard testimony from Dr. John 
Daigh, the Assistant Inspector General for Healthcare Inspections. Dr. 
Daigh was accompanied by Dr. George Wesley, Director of Medical 
Assessment in the Office of Healthcare Inspections, Office of Inspector 
General (OIG); Dr. Jerome Herbers, Associate Director of Medical 
Assessment in the Office of Healthcare Inspections; Dr. Andrea Buck, 
Senior Physician in the Office of Healthcare Inspections; and Dr. Lynn 
Cleg, Mathematical Statistician in the Office of Healthcare 
Inspections. As a follow-up to that hearing, the Subcommittee is 
requesting that the following questions be answered for the record:

    1.  The Subcommittee understands that situation at Marion came to 
the attention of VA's central office via national VA Surgical Quality 
Improvement Program (NSQIP). During the IG's investigation, was there a 
determination as to why the employees at the VA Medical Center in 
Marion never called in to the OIG Hotline or made complaints outside 
the facility regarding the patient care issues at Marion? What 
conclusions, if any, did the IG reach on this issue?
    2.  When will the follow-up report on Marion be published?
    3.  With respect to the three deaths highlighted in the IG report, 
and the other deaths resulting from substandard care identified by the 
Office of the Medical Inspector, did Marion VA Medical Center request 
or did the veterans' families request autopsies? Please provide 
documentation.
    4.  Did the VISN learn about the substandard care at Marion before 
the VA Central Office? If not, why not? If so, please provide timelines 
and actions taken by the VISN to investigate or remedy the situation.
    5.  What directives does VA currently provide to the VISNs for 
providing oversight of the quality of medical care at the medical 
centers within the VISN?
    6.  There appears to be a national problem with obtaining updated 
licensing data from the State licensing boards. Not all boards report 
licensing actions to the National Practitioner Database in a timely 
manner, if at all, and there is no centralized repository for this 
information to be maintained. Is this problem of licensing verification 
limited to the VA or does it cross a wide spectrum of healthcare 
providers? Does the Inspector General's office have any legislative 
recommendations on fixing this problem?
    7.  If the OIG had sufficient resources, what steps would you take 
to ensure that there are no other serious medical and credentialing 
issues, such as those reflected at Marion, occurring in the VA medical 
care system? Under the President's proposed fiscal year 09 budget for 
the OIG of $76 million, would you have sufficient resources to take 
these steps? If not, what additional resources would you need?

    We request you provide responses to the Subcommittee no later than 
close of business, March 28, 2008.
    If you have any questions concerning these questions, please 
contact Subcommittee on Oversight and Investigations Staff Director, 
Geoffrey Bestor, Esq., at (202) 225-3569 or the Subcommittee Republican 
Staff Director, Arthur Wu, at (202) 225-3527.

            Sincerely,
                                                  HARRY E. MITCHELL
                                                           Chairman

                                                  GINNY BROWN-WAITE
                                          Ranking Republican Member
                               __________
                                U.S. Department of Veterans Affairs
                                                    Washington, DC.
                                                     April 25, 2008

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

Dear Mr. Chairman:

    Enclosed are the responses to the questions from the January 29, 
2008, Subcommittee hearing on credentialing and privileging systems at 
the Department of Veterans Affairs. A similar letter is being sent to 
Congresswoman Ginny Brown-Waite, Ranking Republican Member of the 
Subcommittee.
    Thank you for your interest in the Department of Veterans Affairs.

            Sincerely,
                                                Jon A. Wooditch for
                                                    GEORGE J. OPFER
                                                  Inspector General

Enclosure
                               __________
    Responses from the Office of Inspector General to Post Hearing 
      Questions on Credentialing and Privileging Systems at the VA
 1. The Subcommittee understands that the situation at Marion came to 
        the attention of VA's central office via National VA Surgical 
        Quality Improvement Program (NSQIP). During the IG's 
        investigation, was there a determination as to why the 
        employees of the VA Medical Center (VAMC) in Marion never 
        called in to the OIG Hotline or made complaints outside the 
        facility regarding the patient care issues at Marion? What 
        conclusions, if any, did the IG reach on this issue?
    Response: The Office of Inspector General (OIG) analysis found that 
the three mortality cases that did not meet acceptable quality of care 
occurred in July and August of 2007. These deaths created anxiety among 
the staff and that anxiety was transmitted to NSQIP reviewers who 
visited Marion in August of 2007, to review the facility's elevated 
Observed-to-Expected mortality ratio. We concluded that this was the 
first opportunity for staff to raise quality of care issues in person. 
The OIG Hotline did receive an anonymous complaint regarding non-
patient care in April 2007, so we do know that staff was aware of the 
OIG Hotline.
 2. When will the follow-up report on Marion be published?
    Response: Issues not included in the January 28, 2008, report were 
addressed in a separate report that was published on March 26, 2008. An 
OIG review of the Veterans Health Administration's (VHA) Veteran 
Integrated Services Network (VISN) peer review oversight was published 
on April 22, 2008. OIG will follow up with a visit to Marion within the 
next year to assess the implementation of recommendations that were 
agreed upon in the January 28, 2008, report.
 3. With respect to the three deaths highlighted in the OIG report, and 
        the other deaths resulting from substandard care identified by 
        the Office of the Medical Inspector (OMI), did Marion VA 
        Medical Center request or did the veterans' families request 
        autopsies? Please provide documentation?
    Response: The OIG report and the OMI report discussed a total 19 
deaths. Of those 19 deaths, 5 occurred outside the Marion VAMC. Of the 
remaining 14 cases, autopsies were performed in 2 cases. For those two 
cases, we believe that the staff at Marion raised the issue with the 
families. While there is no definitive entry in the records, however, 
we concluded that autopsies were requested by Marion VAMC officials in 
four other cases but they were not performed. Subcommittee staff 
informed us on March 31, 2008, that the request for documentation was 
withdrawn.
 4. Did the VISN learn about the substandard care at Marion before the 
        VA Central Office (VACO)? If not, why not? If so, please 
        provide timelines and actions taken by the VISN to investigate 
        or remedy the situation?
    Response: VACO, the VISN, and the facility were all aware of the 
NSQIP data at about the same time. (Please note the three deaths that 
OIG determined did not meet the standard of care occurred in July 2007 
and August 2007.) A chronology and time of relevant events follows:

      April 10, 2007--NSQIP Program Office sends reports for 
the 1st QTR, 2007, to Chief, Surgery Service, at Marion VAMC with a 
copy to the VAMC Director. The report reveals an elevated Observed-to-
Expected mortality ratio of greater than 4.
      April 26, 2007--NSQIP Program Office sends reports for 
the 1st QTR, 2007, to the VISN 15 Chief Medical Officer.
      April 30, 2007--A Marion VAMC response containing peer 
reviews of the NSQIP identified deaths for 1st QTR, 2007, is created. 
It is sent from the Marion VAMC Chief, Surgery Service, to the Marion 
VAMC Medical Center Director.
      May 1, 2007--The VISN 15 Chief Medical Officer meets with 
the Marion VAMC Medical Center Director. The Medical Center Director 
gives a copy of the Marion VAMC response which contains peer reviews of 
the NSQIP identified 1st QTR, 2007, mortality cases to the Chief 
Medical Officer. This Marion VAMC response contains a brief summary of 
the seven mortality cases identified by NSQIP for 1st QTR, 2007.
      May 1, 2007--Based on contemporaneous discussions, the 
VISN plans to follow up on the Marion VAMC's Chief, Surgery Service's 
review with a second level review.
      May 22-23, 2007--The VISN Chief Medical Officer and 
Marion Chief of Staff meet and discuss the matter at a VISN 15 
leadership board meeting in St. Louis, MO. The Marion VAMC did not 
identify any specific surgeon or procedure as the cause of the elevated 
number of NSQIP deaths in 1st QTR, fiscal year 2007.
      July 3, 2007--During a visit to the Marion VAMC by the 
VISN Chief Medical Officer, discussions regarding the VAMC's surgery 
program take place. These discussions, per the VISN Chief Medical 
Officer, ``indicated expectation for decreased mortality report for 
second quarter, plan to add an additional anesthesiologist--and an 
additional pulmonologist.''
      July 9, 2007--2nd QTR, 2007, NSQIP data become available 
on the NSQIP website. The number of Marion VAMC NSQIP deaths is two for 
this quarter. The cumulative Observed-to-Expected mortality ratio 
(i.e., for 1st QTR + 2nd QTR, 2007) remains greater than 4.
      Mid to late July 2007--VISN 15 Chief Medical Officer 
briefs VISN 15 Network Director on above.
      August 10, 2007--The Marion VAMC Chief of Staff informs 
the VISN Chief Medical Officer that there have been an additional four 
cases of surgical deaths. The surgeon in three of four of these cases 
was the surgeon referred to as Provider #1 in our report.
      August 10, 2007--The VISN Chief Medical Officer arranges 
for these four mortality cases to be peer reviewed at the Kansas City, 
MO, and St. Louis, MO, VAMCs.
      August 13, 2007--Provider #1 resigns his appointment at 
the Marion VAMC.
      August 15, 2007--VISN 15 is notified of an impending 
NSQIP site visit, planned for August 30-31.
      August 27-31, 2007--The Joint Commission visits Marion 
for its triennial survey.
      August 29-30, 2007--NSQIP site visit occurs. Based on 
initial findings by the NSQIP team, the VISN Network Director stands 
down inpatient surgery at the Marion VAMC. VA Central Office is 
notified.
 5. What directives does VA currently provide to the VISNs for 
        providing oversight of the quality of medical care at the 
        medical centers within the VISN?
    Response: There is no single directive that specifically defines 
the VISN role in the oversight of the quality of care. There are a 
number of directives from VHA that provide guidance regarding the 
performance of quality assurance and related activities:
Patient Safety
      VHA National Patient Safety Improvement Handbook, VHA 
Handbook 1050.1, January 30, 2002
Administrative Boards
      Administrative Investigations, VA Handbook 700, March 25, 
2002
Peer Review
      Peer Review for Quality Management, VHA Directive 2008-
004, January 28, 2008
Tort Claims
      Notification of Medical Malpractice Claims Against 
Licensed Practitioners, VHA Directive 2004-024, June 10, 2004
Utilization Management
      Utilization Management Policy, VHA Directive 2005-040, 
September 22, 2005
Credentialing and Privileging
      Credentialing and Privileging, VHA Handbook 2200.19, 
October 2, 2007
Patient Complaints
      VHA Patient Advocacy Program, VHA Handbook 1003.4, 
September 2, 2005
Mortality Review
      Mortality Assessment, VHA Directive 2005-056, December 1, 
2005
Disclosure of Adverse Events
      Disclosure of Adverse Events to Patients, VHA Directive 
2008-002, January 18, 2008
 6. There appears to be a national problem with obtaining updated 
        licensing data from the State licensing boards. Not all boards 
        report licensing actions to the National Practitioner Database 
        in a timely manner, if at all, and there is no centralized 
        repository for this information to be maintained. Is this 
        problem of licensing verification limited to the VA or does it 
        cross a wide spectrum of healthcare providers? Does the 
        Inspector General's office have any legislative recommendations 
        on fixing this problem?
    Response: The problem of license verification is not limited to VA, 
but affects large multi-State medical care providers, States, and 
others who require this information. OIG has no legislative suggestions 
to address this issue at this time. However, based on questions at the 
hearing, OIG is currently reviewing the issue of disclosure of 
information that is relevant to veterans about the providers and care 
available at the VA; when completed, we will provide the information to 
the Subcommittee.
 7. If the OIG had sufficient resources, what steps would you take to 
        ensure that there are no other serious medical and 
        credentialing issues, such as those reflected at Marion, 
        occurring in the VA medical care system? Under the President's 
        proposed fiscal year 2009 budget for the OIG of $76 million, 
        would you have sufficient resources to take these steps? If not 
        what additional resources would you need?
    Response: OIG believes that VHA medical facilities should be 
subject to a more in-depth and detailed review of their quality 
assurance activities during Combined Assessment Program (CAP) reviews. 
This would include a detailed review of credentialing and privileging 
documents for a sample, if not all, of new physicians and independent 
providers at a medical center. There is a 2-year cycle of credential 
and privileging for physicians, and additional review of the data used 
to re-privilege providers is essential. In addition, OIG needs to 
perform a more detailed review of the ongoing processes that occur in 
response to unexpected or untoward events. Thus, the incident report 
system, medication errors, operating room procedures that are designed 
to insure the correct surgery is performed, and the response to these 
occurrences through corrective action and adverse event reporting to 
patients demand closer oversight. The quality of peer reviews and the 
process by which they are obtained, the usefulness of root cause 
analysis, and the patient safety program require review. It is not 
possible to address these issues during the CAP review at the detailed 
level required and maintain the ability to perform reviews related to 
individual complaints to the OIG Hotline and national reviews at the 
current level of OIG staffing. Twenty additional healthcare inspectors 
are required to address these concerns. New staff would be added to CAP 
review teams and visit facilities and review documents at the facility 
in detail.
    There remain about 800 Community Based Outpatient Clinics (CBOCs) 
and 200 Vet Centers with minimal OIG oversight. A review process, 
similar to a CAP, but designed to review CBOCs on a 3-year cycle would 
require 20 additional healthcare inspectors. During the reviews of 
these facilities, we would review the credentials and privileges of 
CBOC staff.

                                 

                                     Committee on Veterans' Affairs
                       Subcommittee on Oversight and Investigations
                                                    Washington, DC.
                                                      March 3, 2008

Hon. James B. Peake
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420

Dear Secretary Peake:

    On Tuesday, January 29, 2008, the Subcommittee on Oversight and 
Investigations of the House Committee on Veterans' Affairs held a 
hearing on credentialing and privileging systems at the Department of 
Veterans Affairs (VA).
    During the hearing, the Subcommittee heard testimony from Dr. 
Gerald M. Cross, Principal Deputy Under Secretary for Health. Dr. Cross 
was accompanied by Kathryn Enchelmayer, Director of Quality Standards 
for the Veterans Health Administration (VHA); Dr. John Pierce, the 
Medical Inspector for VHA; Nevin Weaver, Director of Workforce 
Management and Consulting for VHA; and Paul Hutter, General Counsel. As 
a follow-up to that hearing, the Subcommittee is requesting that the 
following questions be answered for the record:

     1.  Please provide detailed information regarding all bonuses 
received by senior and middle management at the Marion, IL VA Medical 
Center (Marion) for 2007.
     2.  It has come to the Subcommittee's attention that employees at 
the Marion, IL, VAMC were hesitant to voice concerns over quality of 
care issues for fear of reprisal. What has been done throughout VHA to 
ensure protections for whistleblowers?
     3.  The National Practitioner Data Base (NPDB) system does not 
proactively inform the VA of actions taken against a practitioner 
license, although the Subcommittee has learned that a prototype to 
provide Proactive Disclosure Services (PDS) is being developed. When 
does VA plan to enroll in the prototype? How many practitioners will be 
enrolled by the VA under the PDS?
     4.  What is the cost to the VA for enrolling its practitioners in 
the PDS, and where will the funding come from to enroll each 
practitioner at the VA medical facilities?
     5.  Marion had only three surgeons on staff, with differing 
specialties, who were responsible for peer review of each other's work. 
How many VA hospitals are in a similar situation of having a small 
number of doctors conducting peer review and/or not having expertise in 
specialties that are being reviewed?
     6.  The Committee understands that VHA currently has a team 
working on matching size and capabilities of each medical facility with 
the clinical privileges that each facility is able to support. When 
will VA report back to Congress on the completion of this process?
     7.  How and when does the VA intend to provide outreach and 
information to patients/families provided substandard care at Marion?
     8.  Did information about morbidity and mortality rates at Marion 
come to the attention of the VISN before VA's Central Office (VACO) 
observed the spike in expected mortalities in the National VA Surgical 
Quality Improvement Program (NSQIP)? If so, please explain the 
circumstances and describe what steps the VISN took in response.
     9.  What is VA's enterprise wide remediation plan to address the 
serious medical and credentialing issues that were taking place at 
Marion, and ensure similar situations are not occurring elsewhere in 
the VA system?
    10.  A significant part of the serious problems at Marion resulted 
from the fact that information about excessive mortality and morbidity 
rates, the breakdown of the peer review process, and the apparent 
failure of the facility to consider relevant information when granting 
privileges, did not make its way outside of the facility until much of 
the damage had been done. Describe in detail the steps VA is taking to 
ensure that local breakdowns in these or other areas come to the 
attention of management in a more timely way and in a manner that will 
guarantee management response.
    11.  As a result of the events at Marion, has VA identified any 
issues with NSQIP? Do not limit your response to the question of 
whether NSQIP is an effective tool to identify issues requiring 
immediate attention. Please tell us about any ways in which NSQIP could 
be improved and what VA is doing to realize these improvements.

    We request you provide responses to the Subcommittee no later than 
close of business on March 28, 2008.
    If you have any questions concerning these questions, please 
contact Subcommittee on Oversight and Investigations Staff Director, 
Geoffrey Bestor, Esq., at (202) 225-3569 or the Subcommittee Republican 
Staff Director, Arthur Wu, at (202) 225-3527.

            Sincerely,
                                                  HARRY E. MITCHELL
                                                           Chairman

                                                  GINNY BROWN-WAITE
                                          Ranking Republican Member
                               __________
                        Questions for the Record
                    Hon. Harry E. Mitchell, Chairman
           Hon. Ginny Brown-Waite, Ranking Republican Member
              Subcommittee on Oversight and Investigations
                   House Veterans' Affairs Committee
                            January 29, 2008
Credentialing and Privileging Systems at the Department of Veterans Affa
                                  irs
    Question 1: Please provide detailed information regarding all 
bonuses received by senior and middle management at the Marion, IL VA 
Medical Center (Marion) for 2007.

    Response: No bonuses were awarded to senior or mid-level managers 
at Marion in 2007.

    Question 2: It has come to the Subcommittee's attention that 
employees at the Marion, IL, VAMC were hesitant to voice concerns over 
quality of care issues for fear of reprisal. What has been done 
throughout VHA to ensure protection for whistleblowers?

    Response: The No FEAR Act training, which includes whistleblower 
protection, is mandatory for all employees. It is offered at new 
employee orientation and then annually to all VA employees. This 
training is continually enforced through various communications such as 
newsletters, e-mail, other training modules available on web-based 
training and through the Compliance and Business Integrity Office. The 
Office of Human Resource Management (OHRM) Intranet Web page contains 
information on the No FEAR Act and is available to VA employees at: 
http://vaww1.va.gov/ohrm//EmployeeRelations/Grievance.htm
    Information from the link above including the VA No FEAR Act notice 
were issued to employees at Marion and Evansville during the November 
assessment.
    Information on the No FEAR Act pertaining to VA is available on the 
Internet at: http://www.va.gov/orm/NOFEAR_Select.asp

    (Note: A No FEAR Act notice that will bear the Secretary's 
signature is in the internal concurrence process. This notice will 
affirm the Secretary's commitment to the No FEAR Act and direct the 
employees to the aforementioned links.)

    Question 3: The National Practitioner Data Base (NPDB) system does 
not proactively inform the VA of actions taken against a practitioner 
license, although the Subcommittee has learned that a prototype to 
provide Proactive Disclosure Services (PDS) is being developed. When 
does VA plan to enroll in the prototype? How many practitioners will be 
enrolled by the VA under the PDS?

    Response: VA will mandate enrollment of all licensed independent 
providers in the national practitioner database's (NPDB) proactive 
disclosure service as soon as software modifications are made to 
VetPro. The contract for the software modifications to VetPro is 
pending. Once software modifications are made, VA medical centers 
(VAMC) will have 30 days in which to enroll all licensed independent 
practitioners. It is expected that approximately 56,000 practitioners 
will be enrolled.

    Question 4: What is the cost to the VA for enrolling its 
practitioners in the PDS, and where will the funding come from to 
enroll each practitioner at the VA medical facilities?

    Response: VA has approximately 56,000 licensed independent 
practitioners. The cost per practitioner is $3.25 per year. Each 
facility where a practitioner is appointed must register the 
practitioner. It is estimated that VA has approximately 2,500 
practitioners appointed at more than one facility. Therefore, the cost 
for the initial enrollment of all VA practitioners in the NPDB PDS is 
estimated to be $190,125. The annual recurring cost of maintaining 
current licensed independent practitioners as well as the enrollment of 
new practitioners is expected to be $213,200. Practitioners can only be 
enrolled during the period of time they are affiliated with a VAMC. If 
a practitioner leaves VA or transfers from one facility to another the 
enrollment would be terminated by the departing facility and re-
enrolled by the gaining facility. There is no prorated cost for only 
part of the year registration. Individual facilities will incur the 
cost.

    Question 5: Marion has only three surgeons on staff, with differing 
specialties, who were responsible for peer review of each other's work. 
How many VA hospitals are in a similar situation of having a small 
number of doctors conducting peer review and/or not having expertise in 
specialties that are being reviewed?

    Response: Prior to the release of the Veterans Health 
Administration (VHA) Directive 2008-004, if a facility did not have the 
capability to perform peer review, the facility staff sought review 
from another facility. VHA Directive 2008-004, (released January 28, 
2008) states that the VAMC Chief of Staff will coordinate arrangements 
for the review to be conducted at another VAMC. Veteran Integrated 
Services Network (VISN) leadership is responsible for ensuring 
implementation of and compliance with the policy. The VISN Director is 
responsible to ensure there is an adequate review of the information 
provided and review of information from VAMC on variances and 
initiation of appropriate actions. This might include a request for an 
external review or a site visit be conducted to review the peer review 
process. The VISN Director must ensure that there is at least an annual 
inspection of the peer review process in all VISN medical centers.
    VA is preparing a contract for an external entity to validate the 
VA peer review process. The purpose of the external peer review 
contract is to detect patterns of inaccurate or inadequate peer review 
in any VAMC through an audit of high risk cases and to provide 
standardized information to individual VAMCs that identify 
opportunities to improve care through the peer review process. The 
external review will provide additional assurance of quality of care in 
small and large VAMCs by conducting focused, independent (external) 
case level quality of care assessment.

    Question 6: The Committee understands that VHA currently has a team 
working on matching size and capabilities of each medical facility with 
the clinical privileges that each facility is able to support. When 
will VA report back to Congress on the completion of this process?

    Response: VHA is engaged in conducting a surgery-only operative 
complexity study and we expect to have a report by the end of July 
2008.

    Question 7: How and when does the VA intend to provide outreach and 
information to patients/families provided substandard care at Marion?

    Response: On January 28, 2008, simultaneous with the release of the 
Office of the Medical Inspector (OMI) and the Office of Inspector 
General (OIG) reports, patient and family notifications were initiated 
for cases in which the OMI found that substandard care provided to 
veterans resulted in harm. Arrangements were made for personal 
disclosure conferences coordinated by the OMI, Regional Counsel, VISN 
15 Chief Medical Officer and VBA. Between January 30 and February 7, 
2008, 24 of these meetings were completed and an additional two 
meetings were completed as of March 6, 2008. The meetings include a 
discussion of findings by an OMI physician, a discussion of legal and 
benefit options by Regional Counsel and VBA representatives, and the 
assignment of a local liaison (social worker or psychologist) for any 
further questions. Pastoral counseling is also offered at the 
conclusion of the meeting. Contacts were made by telephone and letter, 
and at this time we have confirmed receipt by all veterans or families 
identified by OMI. Some declined the offer of a meeting, others elected 
to have their attorneys meet directly with regional counsel, and others 
have requested to defer the scheduling of a meeting. We will continue 
this process until all of the identified veterans or family/families 
who desire a disclosure meeting have had this opportunity.

    Question 8: Did information about morbidity and mortality rates at 
Marion come to the attention of the VISN before VA's Central Office 
(VACO) observed the spike in expected mortalities in the National 
Surgical Quality Improvement Program (NSQIP)? If so, please explain the 
circumstances and describe what steps the VISN took in response.

    Response: In January 2007, the VISN Chief Medical Officer (CMO) 
received from National Surgical Quality Improvement Program (NSQIP) the 
fiscal year (FY) 2006 annual report concerning all facilities within 
the VISN. The surgical mortality data (observed/expected) for the 
Marion facility was 0.88 (less than the ``expected'' ratio of 1.0). In 
late April 2007, the VISN CMO received from NSQIP the first quarter FY 
2007 data which reflected an increase in expected mortality at the 
Marion facility. The CMO met personally with the Marion VAMC Director 
at the VISN office in Kansas City on May 1, 2007, at which time the 
data, and a summary report of case reviews from the Marion Chief of 
Surgery were reviewed. A plan of action was discussed, including a plan 
for second level case review within the facility and additional support 
for surgical care, including the addition of a second anesthesiologist 
and organizational changes for the surgical program. The VISN Director 
was briefed by the CMO. Later in May 2007, the CMO met with the VAMC 
Director and Chief of Staff and discussed findings of the second 
reviews, which did not identify a specific procedure or individual 
surgeon as an etiology of the increase. In July 2007, the VISN CMO 
visited the Marion facility and met with the Chief of Staff. Second 
quarter NSQIP data reflected that the cumulative mortality rate for the 
year remained high but the number of deaths had decreased significantly 
in the second quarter. Additional actions at that time included 
recruitment of a third anesthesiologist and an additional pulmonary/
critical care physician to the facility. On August 10, 2007, the VISN 
CMO was notified of additional surgical deaths, primarily involving a 
single surgeon, who resigned the following day. The VISN CMO arranged a 
case review of these cases to be performed by surgeons outside of the 
Marion facility. The plan for a NSQIP site visit was arranged on August 
15, 2007.

    Question 9: What is VA's enterprise wide remediation plan to 
address the serious medical and credentialing issues that were taking 
place at Marion, and ensure similar situations are not occurring 
elsewhere in the VA system?

    Response: VA is preparing a contract for an entity external to VA 
to validate the VA peer review process. The purpose of the external 
peer review contract is to detect patterns of inaccurate or inadequate 
peer review in any VAMC through an audit of high risk cases and to 
provide standardized information to individual VAMCs that identify 
opportunities to improve care through the peer review process. The 
external review will provide additional assurance of good quality of 
care in small and large VAMCs by conducting focused, independent 
(external) case level quality of care assessment.
    A meeting was held with senior leadership in The Office of 
Acquisition and Material Management. The contracting officer is 
identified as well as the contracting officer's technical 
representative. The core package for the solicitation is complete. Due 
to the size of this contract, estimated to be between $15 to $25 
million over the 5 year span of the contract, a technical team is being 
assembled that will include not only staff from the Offices of Quality 
and Performance and Acquisition and Material Management, but also 
Office of Congressional and Legislative Affairs, Office of Public 
Affairs, and Office of General Counsel. This team will determine the 
type of contract to be competed; schedule a day for industry to gain 
information on the proposed contract prior to solicitation; and plan 
the solicitation. Industry must be given sufficient time to respond to 
the solicitation. It is anticipated that this contract will be awarded 
mid-to-late summer 2008.
    VHA Directive 2008-008, requires that the VISN Director ensures 
there is an adequate review of the information provided and review of 
information from VAMCs on variance and initiation of appropriate 
actions. This might include a request that an external review or a site 
visit be conducted to review the peer review process. The VISN Director 
must also ensure that there is at least an annual inspection of the 
peer review process in all VISN medical centers.
    The major medical issues that have become apparent through our 
analysis of the Marion situation are fundamentally attributable to 
systems and complexity management. Specifically, the ability to deliver 
safe and high quality surgical and procedural care is dependent not 
only on the skills of a given surgeon or operator, but also on the team 
supporting them as well as the institutional capabilities, including 
response times for key services. Thus, remediation requires not only 
ensuring the capability of the primary operators through the 
credentialing process, but also on better understanding and ensuring 
that the proper support is in place across all levels.
    A task force has been working to analyze, report, and make 
recommendations for an enterprise wide approach to managing surgical 
complexity. That process has developed methodology for ranking the 
complexity of all surgical procedures and for assigning facilities a 
complexity ranking based on a broad range of capabilities including 
space, equipment, staff, consultative support for both pre- and post-
operative care, and response times. In addition, there are patient 
characteristics that also being factored into this equation. These are 
being assembled into a `matrix' that will ensure procedures are only 
performed in the appropriate environments, by the appropriate 
operators, with appropriate support at all levels. This process will be 
presented at a VHA-wide quality conference next week, (April 1-4, 
2008).
    A charge has been developed to assemble a similar task force to 
review all non-surgical procedures, such as cardiac interventions, to 
ensure that the same level of assurance is available for where and by 
whom medical procedures are being performed.
    VHA has initiated a broad review of its clinical tracking programs, 
including NSQIP. The validity of our statistical methodologies will be 
subjected to external review as will the methodologies for data 
management and the entire structure for data reporting being evaluated 
internally. The goal is to strengthen both the robustness of the 
program and its ability to enhance facility performance. A national 
quality monitoring program is also under development for the non-
surgical procedures, beginning with the cardiac catheterization lab 
procedures. This group is charged with developing processes for 
national monitoring of quality and outcomes for cardiac interventions, 
as well as processes for remediation when problems are identified.
    As patient complexity increases, so does the need for higher levels 
of support. Toward this end there are ongoing systematic reviews and 
enhancements of both intensive care units (ICU) and emergency 
departments throughout VHA. A system-wide methodology for monitoring 
key outcomes measures in ICU patients (IPEC) is being extended to 
include all medical-surgical beds; a program to expand the availability 
of intensivists and hospitals, especially for lower complexity 
facilities, is being developed. Emergency departments are being 
standardized across VHA to ensure early management of acutely ill 
patients is optimized and appropriately meets the needs of the 
facilities. A pilot for providing higher lever intensivist support to 
smaller facilities and to improve house-staff supervision for 
facilities with residency programs is being developed using a ``virtual 
ICU'' monitoring system.
    The overall goal for all of these initiatives is to ensure that all 
health care delivery across VHA is performed in the environment and at 
the time most suited for the complexity of the patients and procedures.

    Question 10: A significant part of the serious problems at Marion 
resulted from the fact that information about excessive mortality and 
morbidity rates, the breakdown of the peer review process, and the 
apparent failure of the facility to consider relevant information when 
granting privileges, did not make its way outside of the facility until 
much of the damage had been done. Describe in detail the steps VA is 
taking to ensure that local breakdowns in these or other areas come to 
the attention of management in a more timely way and in a manner that 
will guarantee management response.

    Response: A new Acting Director and Acting Chief of Staff are in 
place and recruitment for permanent positions is underway. The facility 
has been working with the National Center for Organizational 
Development (NCOD) on an ongoing basis to assist with improving 
employee communication and satisfaction.
    Additional staff was added for quality management in order to 
provide additional focus, tracking and management of the peer review 
program. A national practitioner data bank (NPDB) query was obtained 
for all staff physicians in October as a proactive process to identify 
potential issues. Clinical privileges for all procedures have been 
reviewed and adjusted as appropriate to both provider and 
organizational factors.
    Joint Commission has conducted a full survey (late August) and 
three follow-up unannounced surveys, and the facility remains fully 
accredited.
    The facility is moving forward with other clinical programs, 
including the recent opening of an expanded mental health clinical 
space, with plans in progress for a clinical annex for the Marion 
facility and expanded space for the Mt. Vernon and Effingham Community 
Based Outpatient Clinics (CBOC).
    VA published VHA Directive 2008-004, Peer Review for Quality 
Management, January 28, 2008, clearly defines the roles and 
responsibilities of not only medical center leadership but also VISN 
and VHA headquarters leadership in the oversight of the peer review 
process and ensures that the review of facility information occurs at 
least quarterly with an annual inspection. Additionally, VA is 
preparing to complete a contract for an entity external to VA to 
validate the VA peer review process. The purpose of the external peer 
review contract is to detect patterns of inaccurate or inadequate peer 
review in any VAMC through an audit of high risk cases and to provide 
standardized information to individual VAMCs that identify 
opportunities to improve care through the peer review process. The 
external review will provide additional assurance of good quality of 
care in small and large VAMCs by conducting focused, independent 
(external) case level quality of care assessment.
    VA required training of all medical staff leaders on the importance 
of the credentialing and privileging process using three Web based 
training modules. This training included identifying the roles and 
responsibilities of medical staff leaders in the credentialing and 
privileging process as well as requirements for effective 
implementation of ongoing monitoring of practitioner competency and 
continuous professional practice evaluations. The required training was 
completed January 31, 2008; and over 3,200 medical staff leaders took 
each of the three training modules.
    In October 2007, VA implemented VISN-level review of practitioners 
prior to appointment by a medical center if the practitioner meets one 
of three medical malpractice criteria. These criteria are:

    1.  Three or more medical malpractice payments in payment history;
    2.  Two medical malpractice payments totaling $1,000,000 or more; 
or
    3.  A single medical malpractice payment of $550,000 or more.

    During this second level review, VISN leadership has an opportunity 
to review and provide oversight to the credentialing and privileging 
process at the medical center level and determine if any additional 
follow-up is required.
    In addition to statistical data measures, VHA also has an internal 
quality review team. The System-wide Ongoing Assessment Review Strategy 
(SOARS) mission is to provide assessment and educational consultation 
to VHA facilities using a systematic method for on-going self-
improvement. SOARS also provide continuous readiness to reduce survey 
preparation anxiety and chaos, and help prevent and reduce repeat or 
high risk recommendations from external reviews and proactively 
identify areas of potential risk.

    Question 11: As a result of the events at Marion, has VA identified 
any issues with NSQIP? Do not limit your response to the question of 
whether NSQIP is an effective tool to identify issues requiring 
immediate attention. Please tell us any ways in which NSQIP could be 
improved and what VA is doing to realize these improvements.

    Response: In 1991, the National Surgical Quality Improvement 
Program (NSQIP) was established as a Special Purpose Workgroup (SPW) 
under the Office of Patient Care Services. It was developed to provide 
data to Veterans Health Administration (VHA) operations and field 
entities for enhanced monitoring of specific surgical outcomes. NSQIP 
also responded to quality issues raised by the VHA field or Central 
Office entities. Public Law (PL 99-166 December 3, 1985, Subchapter V 
Quality Assurance) stated that VHA compare its mortality and morbidity 
``from prevailing national mortality and morbidity standards for 
similar procedures.''
    NSQIP analysis was initially based on two key hypotheses:

    1.  Surgical morbidity and mortality rates are determined by 
patient-related risk factors such as primary disease, extent of 
disease, comorbid conditions, and sociodemographics and by a range of 
processes related to health care providers, the facilities, and 
institutional policies.
    2.  After adjustment for patient specific preoperative (risk) 
factors, operative mortality and morbidity indicate the quality of 
processes and structures of surgical care at a particular institution.

    Aggregate reports of observed to expected (O/E) ratios of morbidity 
and mortality for each facility have proven to be important instruments 
for monitoring and improving the quality of care, originally based on 
facility action and later based upon widespread sharing with Veteran 
Integrated Services Networks (VISNs) and VA Central Office (VACO) 
entities. Risk-adjusted aggregated data calculations are based upon 
logistic modeling of all procedures for a given fiscal year.
    Although the accuracy of data collected was verified by the VA 
Office of the Medical Inspector (OMI), over time it became clear that 
quality programs need to be more nimble, timely, and detailed with 
their reporting in order to provide a true oversight function. The 
assumption that providing annual risk-adjusted data to field and VACO 
entities would, in itself, improve results in specific facilities was 
not validated, although overall aggregate results improved over the 
decade the program had existed.
    Starting in 2005, a number of changes were initiated with the 
intent to make NSQIP an improved oversight tool. NSQIP expanded its 
activities to include quarterly reports to VA operations, to focus upon 
results of specific operations including colectomy, bariatric 
procedures aneurysm repair, pancreatectomy, and transplant procedures. 
Actual mortality figures in addition to risk adjusted ratios are now 
calculated and compared to national averages.
    In 2007, NSQIP initiated a web-based, color coded, quarterly 
website dashboard reporting system. This provided statistical 
evaluation of outliers based on a probability of 0.10 for both O/E 
ratios and actual mortality. Out of necessity, the ongoing web-based 
calculations were based upon hierarchical modeling of the performances 
of the previous year for comparison.
    In addition, NSQIP can now tabulate quarterly aggregate patient 
safety issues, including correct site surgery and prevention of 
retained surgical item in response to VHA Directives 2004-028 and 2006-
030.
    In the case of Marion, these proactive, programmatic enhancements 
enabled the Office of Patient Care Services to detect serious 
performance concerns that had recently arisen. In order to further 
improve its capabilities NSQIP has added a senior nurse Validation 
Manager and is in the process of adding more enhancements which include 
additional statistical personnel, Bayesian Statistics for small number 
detection of outliers, and ongoing real-time comparisons of actual and 
expected mortality. An operating room supervisors' national conference 
stressing quality and safety along with a general educational meeting 
are scheduled for April 2008.
    Two work groups were appointed by the Under Secretary for Health to 
further evaluate NSQIP procedures and surgical complexity at all 
facilities. The Surgical Quality Work Group will include in their 
review the capture of critical or sentinel events for urgent review and 
the use of rolling six-month NSQIP averages to provide greater 
sensitivity to changes that occur between fiscal year comparisons. The 
Operative Complexity Work Group will provide a template of surgical 
complexity of all procedures to assure that a procedure and the 
facility complexity and its support structures are in alignment.
    To further ensure that medical center and VISN leadership 
comprehend and effectively utilize NSQIP, a conference on Quality 
Enhancement is planned for April 2008. All VAMC Chief of Staff and 
Nurse Executives, in addition to VISN CMO and QMO are expected to 
attend. There are two required sessions specifically, discussing NSQIP 
at this conference.

                                 
                               U.S. Department of Veterans Affairs,
                                                    Washington, DC.
                                                       May 14, 2008

Hon. Bob Filner
Chairman
Committee on Veterans' Affairs
U.S. House of Representatives
Washington, DC 20515

Dear Mr. Chairman:

    This letter transmits the views of the Department of Veterans 
Affairs (VA) on H.R. 4463, the ``Veterans Health Care Quality 
Improvement Act.'' The bill contains numerous provisions that are 
excessively prescriptive and would impede the operations and structure 
of the Veterans Health Administration (VHA). We have enclosed a 
sectional analysis, which addresses each section in depth. A copy of 
this letter is also being sent to Congressman Miller, who requested 
these views at a recent hearing held on January 29, 2008, before the 
Subcommittee on Oversight and Investigations.
    The Department strongly opposes two provisions of H.R. 4463. The 
first would require that within one year of appointment, each physician 
practicing at a VA facility (whether through appointment or 
privileging) be licensed to practice medicine in the State where the 
facility is located. VHA is a nationwide health care system. By current 
statute, VA practitioners may be licensed in any State.
    If this requirement were enacted, it would impede the provision of 
health care across State borders and reduce VA's flexibility to hire, 
assign and transfer physicians. VA makes extensive use of telemedicine. 
This requirement also would significantly undermine VA's capacity and 
flexibility to provide telemedicine across State borders. In addition, 
VA's ability to participate in partnership with our other Federal 
health care providers would be adversely impacted in times such as the 
aftermath of Hurricanes Katrina and Rita, where we are required to 
mobilize members of our medical staff in order to meet regional crises.
    Currently, physicians who provide medical care elsewhere in the 
Federal sector (including the Army, Navy, Air Force, U.S. Public Health 
Service Commissioned Corps, U.S. Coast Guard, Federal Bureau of Prisons 
and Indian Health Service) need not be licensed where they actually 
practice, so long as they hold a valid State license. Requiring VA 
practitioners to be licensed in the State of practice would make VA's 
licensure requirements inconsistent with these other Federal health 
care providers and negatively impact VA's recruitment ability. In 
addition, many VA physicians work in both hospitals and community-based 
outpatient clinics. Many of our physicians routinely provide care in 
both a hospital located in one State and a clinic located in another 
State. A requirement for multiple State licenses would place VA at a 
competitive disadvantage in recruitment of physicians relative to other 
health care providers.
    Although the provision would allow physicians one year to obtain 
licensure in the State of practice, many States have licensing 
requirements that are cumbersome and require more than one year to 
meet. Such a requirement could disrupt the provision of patient care 
services while VA physicians try to obtain licensure in the State where 
they practice or transfer to VA facilities in States where they are 
licensed.
    Further, we are not aware of any evidence of a link between 
differences in State licensing practices and quality of patient care. 
In 1999, the Government Accountability Office (GAO) reviewed the effect 
on VA's health care system that a requirement for licensure in the 
State of practice would have. The GAO report concluded, in part, that 
the potential costs to VA of requiring physicians to be licensed in the 
State where they practice would likely exceed any benefit, and that 
quality of care and differences in State licensing practices are not 
directly linked. See GAO/HEHS-99-106, ``Veterans' Affairs: Potential 
Costs of Changes in Licensing Requirement Outweigh Benefit'' (May 
1999).
    The other objectionable provision in H.R. 4463 would require that 
the Under Secretary for Health be a board-certified physician. Public 
Law 108-422, section 503, removed the requirement that the Under 
Secretary for Health be a doctor of medicine. Section 3(b) would undo 
this recent amendment, which affords the President greater flexibility 
in appointing, and the Senate in confirming, the best-qualified 
individual. The current statute appropriately requires the Under 
Secretary for Health to be appointed solely on the basis of 
demonstrated ability in the medical profession, in health care 
administration and policy formulation, or in health care fiscal 
management, and on the basis of substantial experience in connection 
with VHA programs or programs of similar content and scope.
    The Office of Management and Budget advises that there is no 
objection to the submission of this report from the standpoint of the 
Administration's programs.
    We appreciate the opportunity to comment on this bill. Copies of 
this bill report are being transmitted to Senators Akaka and Durbin 
(who also requested the Department's views).

            Sincerely yours,
                                               James B. Peake, M.D.
                                                          Secretary
                               __________
                           SECTION BY SECTION
Section 2. Standards for Appointment and Practice of Physicians in 
        Department of Veterans Affairs Medical Facilities.
    Section 2(a)(1) of the bill would amend Subchapter I of chapter 74 
of title 38, United States Code, to add a new section 7402A, 
Appointment and practice of physicians: standards.
    New section 7402A(a) would require the Secretary, through the Under 
Secretary for Health, to prescribe standards for appointment and 
practice as a VA physician that incorporate the requirements of Section 
2 of the bill. New section 7402A(b) would require physicians, as a 
condition of appointment to VA, to provide a full and complete 
explanation to VA of each lawsuit, civil action, or other claim 
(whether open or closed) against them for medical malpractice or 
negligence (except those closed without judgment against or payment by 
them or on their behalf); each payment made by or on their behalf to 
settle any such lawsuit, action or claim; and each investigation of 
disciplinary action taken against them relating to their performance as 
a physician.
    These provisions are unnecessary. Qualification requirements for 
appointment as a VA physician are set forth in 38 U.S.C. Sec. 7402. To 
be eligible for appointment in VHA, a physician must hold the degree of 
doctor of medicine or doctor of osteopathy from a college or university 
approved by the Secretary, have completed an internship satisfactory to 
the Secretary, and be licensed to practice medicine, surgery, or 
osteopathy in a State. Except as provided in 38 U.S.C. Sec. 7407(a), a 
physician also must be a U.S. citizen and possess basic proficiency in 
spoken and written English. Furthermore, physicians who have or have 
had multiple licenses, registrations, or State certifications are 
subject to the employment restrictions in 38 U.S.C. Sec. 7402(f) for 
any license terminations or surrenders for cause (i.e., for reasons of 
substandard care, professional misconduct or professional 
incompetence). By policy, all physicians must undergo a rigorous 
credentialing process. VA already requires all applicants and employed 
physicians to disclose the following: any involvement in 
administrative, professional or judicial proceedings, including Federal 
tort claims proceedings, in which malpractice is, or was, alleged; 
anything that would adversely affect or limit their clinical 
privileges, including previous adverse privileging actions; and 
anything that has or would adversely affect or limit their professional 
credentials, including licensure, registration, certification, 
individual DEA certification, and/or other relevant credentials.
    Failure to provide this information on an application is considered 
falsification and may be sufficient grounds for denial of appointment 
or termination from employment. In addition, at a minimum of every two 
years, VA physicians are required to resubmit their applications for 
clinical privileges. A physician who fails to disclose the requested 
information at the time of this reappraisal may be terminated.
    VA has no objection to requiring physicians seeking appointment to 
authorize their State licensing board(s) to disclose information to VA 
concerning lawsuits, claims, investigations, payments, etc. However, 
legislation is not required. The Under Secretary for Health issued 
policy that took effect on January 1, 2008, that would require all 
applicants to sign a written request to State licensing board(s) 
authorizing the release of this information to VA.
    New section 7402A(c) would require physicians, as a condition of 
continuing service under the appointment, to agree to disclose within 
30 days of occurrence each medical malpractice or negligence judgment 
against them; payments made by or on their behalf to settle any 
lawsuit, action, or claim for medical malpractice or negligence; and 
any disposition of or material change in such matters. It also would 
require physicians to biennially submit the written request and 
authorization to the State licensing board(s) described in section 
7402A(b) as part of the biennial review of their performance as a 
physician.
    This provision is also unnecessary. By policy, VA physicians 
already are required to disclose anything that would adversely affect 
or otherwise limit their appointment and/or clinical privileges, 
including any changes in the status of their credentials; any 
involvement in administrative, professional or judicial proceedings, 
including Federal tort claims proceedings, in which malpractice is, or 
was, alleged; and any previous adverse privileging actions. Failure to 
do so may result in administrative or disciplinary action.
    New section 7402A(d) would require the Regional Director of the 
relevant Veteran Integrated Services Network (VISN) to perform and 
fully document a comprehensive investigation of each matter disclosed 
concerning the physician seeking appointment or continued employment in 
that VISN. New section 7402A(e) would require the Regional Director of 
the relevant VISN to approve the appointment of the physician, and 
provide written certification that each disclosed matter had been 
investigated, and written justification why any matters raised in the 
course of investigation would not disqualify the individual from 
appointment.
    These provisions too are unnecessary. The Deputy Under Secretary 
for Health for Operations and Management issued guidance on October 10, 
2007, that instituted system-wide changes to help ensure that the 
credentialing and privileging system is optimized throughout VHA 
Changes include a requirement that the Service Chiefs personally 
document their own review of all licensed health care practitioners. 
Where the physician has a record flagging, VHA must obtain primary 
source verification and documentation of the flagging issues. The 
Service Chief's comments on the appraisal documents must reflect an 
analysis of the issue and recommendations.
    Where the response to the National Practitioner Data Bank-Health 
Integrity and Protection Data Bank query displays any of the criteria 
listed below, the credentialing staff will refer the credentials file 
to the VISN Chief Medical Officer (CMO), prior to presentation to the 
Executive Committee of the Medical staff for review and recommendation 
whether to continue the appointment and privileging process. These 
criteria are:

    1.  Three or more medical malpractice payments in payment history,
    2.  A single medical malpractice payment of $550,000 or more, or
    3.  Two medical malpractice payments totaling $1,000,000 or more.

    The VISN CMO will review all circumstances, including the 
individual's explanation of the specific circumstances in each case and 
the primary source verification of the bases for medical malpractice 
payments, to determine whether the appointment is appropriate. If a 
query about a license results in a report of surrender or revocation, 
primary source documentation of the action will be obtained from the 
licensing board. The credentials file will be reviewed with Regional 
Counsel, or designee, to determine if the practitioner meets 
appointment requirements. In all circumstances where information from 
the primary source indicates there is an ongoing investigation, follow-
up with the licensing board must occur at least monthly and be 
documented in VetPro. In addition, the Office of Quality and 
Performance (OQP) will forward any alerts received from the Federation 
of State Medical Boards (FSMB) Disciplinary Alert Service to the 
appropriate medical center staff within 24 hours. Once the licensing 
board takes final action, the service chief and the Executive Committee 
of the Medical Staff must review the practitioner's privileges and 
appointment to determine if any action is necessary. The credentialer 
must document this review, and any necessary action, in the 
practitioner's credentialing and privileging record.
    In July 2007, VA launched training modules specific to the roles 
and responsibilities of medical staff leadership in the credentialing 
and privileging process. This is mandatory training for all medical 
center Directors, Chiefs of Staff, Chiefs of Quality Management, Chiefs 
of Services with credentialed staff, VISN CMO, and VISN Quality 
Management Officer. This was accomplished by January 31, 2008.
    New section 7402A(f) would provide that a physician may not be 
appointed to VA unless board certified in the specialties of practice. 
However, this requirement may be waived (not to exceed one year) by the 
Regional Director for individuals who complete a residency program 
within the prior two year period and provide satisfactory evidence of 
an intent to become board certified.
    VA opposes this provision. Current statute does not require board 
certification as a basic eligibility qualification for employment as a 
VA physician. VA policy currently provides that board certification is 
only one means of demonstrating recognized professional attainment in 
clinical, administrative or research areas, for purposes of 
advancement. However, facility directors and Chiefs of Staff must 
ensure that any non-board certified physician, or physician not 
eligible for board certification, must be otherwise, well qualified and 
fully capable of providing high-quality care for veteran patients. VA 
is entitled to considerable deference regarding the standards of 
professional competence that it requires of its medical staff, 
including whether the requirement for specialty certification is 
reasonable and not applied arbitrarily and capriciously. Were this 
measure enacted, the requirements could potentially induce a chilling 
effect, impeding our ability to recruit the most qualified physicians 
and provide the best care possible to veterans. At this point in time, 
VA has physician standards that are in keeping with those of the local 
medical communities.
    New section 7402A(g) would require that within one year of 
appointment each physician practicing at a VA facility (whether through 
appointment or privileging) be licensed to practice medicine in the 
State where the facility is located.
    VA strongly objects to enactment of section 7402A(g). VHA is a 
nationwide health care system. By current statute, VA practitioners may 
be licensed in any State. If this requirement were enacted, it would 
impede the provision of health care across State borders and reduce 
VA's flexibility to hire, assign and transfer physicians. VA makes 
extensive use of telemedicine. This requirement also would 
significantly undermine VA's capacity and flexibility to provide 
telemedicine across State borders. In addition, VA's ability to 
participate in partnership with our other Federal health care providers 
would be adversely impacted in times such as the aftermath of 
Hurricanes Katrina and Rita, where we are required to mobilize members 
of our medical staff in order to meet regional crises.
    Currently, physicians who provide medical care elsewhere in the 
Federal sector (including the Army, Navy, Air Force, U.S. Public Health 
Service Commissioned Corps, U.S. Coast Guard, Federal Bureau of Prisons 
and Indian Health Service) need not be licensed where they actually 
practice, so long as they hold a valid State license. Requiring VA 
practitioners to be licensed in the State of practice would make VA's 
licensure requirements inconsistent with these other Federal health 
care providers and negatively impact VA's recruitment ability. In 
addition, many VA physicians work in both hospitals and community-based 
outpatient clinics. Many of our physicians routinely provide care in 
both a hospital located in one State and a clinic located in another 
State. A requirement for multiple State licenses would place VA at a 
competitive disadvantage in recruitment of physicians relative to other 
health care providers.
    Although the provision would allow physicians one year to obtain 
licensure in the State of practice, many States have licensing 
requirements that are cumbersome and require more than one year to 
meet. Such a requirement could disrupt the provision of patient care 
services while VA physicians try to obtain licensure in the State where 
they practice or transfer to VA facilities in States where they are 
licensed. The potential costs of this disruption are unknown at this 
time.
    Further, we are not aware of any evidence of a link between 
differences in State licensing practices and quality of patient care. 
In 1999, the Government Accountability Office reviewed the effect on 
VA's health care system that a requirement for licensure in the State 
of practice would have. The GAO report concluded, in part, that the 
potential costs to VA of requiring physicians to be licensed in the 
State where they practice would likely exceed any benefit, and that 
quality of care and differences in State licensing practices are not 
directly linked. See GAO/HEHS-99-106, ``Veterans' Affairs Potential 
Costs of Changes in Licensing Requirement Outweigh Benefit'' (May 
1999).
    New section 7402A(h) would require each VA medical facility to 
enroll each privileged physician in the National Practitioners Data 
Base Proactive Disclosure Service.
    This provision is unnecessary. The Under Secretary for Health has 
directed his staff to work with the National Practitioner Data Bank 
(NPDB)'s Branch of the Department of Health and Human Services to 
enroll VA's licensed independent practitioners in the Proactive 
Disclosure Service. We are currently in the process of establishing a 
system to ensure that all licensed independent practitioners are 
enrolled in that Service.
    Section 2(b) of the bill would provide that the board certification 
and in-State licensure requirements would take effect one year after 
the date of the Act's enactment for physicians on VA rolls on the date 
of enactment. Section 2(b) also would provide that the requirement for 
enrollment in the NPDB Proactive Disclosure Service would take effect 
60 days after the Act's enactment.
    The requirements for board certification and licensure in the State 
of practice could temporarily disrupt VA's operations if physicians are 
unable to obtain board certification and in-State licensure within one 
year, or are unable to transfer to a State where they are licensed.
Section 3. Enhancement of Quality Assurance by the Veterans Health 
        Administration.
    Section 3(a) would amend subchapter II of chapter 73 of title 38, 
United States Code, to add a new section 7311A, Quality assurance 
officers. It would require the Under Secretary of Health to designate a 
National Quality Assurance Officer to be responsible for establishing 
and enforcing VA's quality-assurance program, including a system 
through which employees, on a confidential basis, may submit reports on 
matters relating to quality of care problems, peer review of physician 
actions, and accountability of the facility director and chief medical 
officer for the actions of facility physicians. It also would require 
the designation of a Network Quality Assurance Officer (who is a board 
certified physician) for each VISN, and a Quality Assurance Officer 
(who is a practicing physician at the facility) for each medical 
facility. In addition, it would set up an organizational reporting 
structure regarding the discharge of the responsibilities and duties of 
the quality assurance officers.
    VA already has an organizational structure that includes a national 
Quality and Performance Office, headed by the Chief Quality and 
Performance Officer, who is required to be a physician. Each of VA's 21 
VISNs has a Quality Management Officer, and each of VA's 153 hospitals 
has a Quality Manager. These employees are not required to be 
physicians because VA believes it is more important that they fully 
understand how to manage reviews of quality of care processes at the 
facilities to which they are assigned. Very few physicians have the 
specific knowledge needed to accomplish this task. The industry 
standard for hiring qualifications of a Quality Manager is a graduate 
level nurse with advance training in Quality Management. Quality 
Managers are tasked to oversee the quality of care processes at their 
facilities, and refer issues that need to be reviewed to the 
appropriate individual, Committee, or facility leader for appropriate 
action. As noted below in analysis of section 3(c), VA already has a 
confidential process for reporting problems with the quality of care 
furnished by VHA.
    Section3(b) would amend section 305(a)(2) of title 38, United 
States Code, to require that the Under Secretary for Health be a board-
certified physician.
    VA opposes this provision. Public Law 108-422, section 503, removed 
the requirement that the Under Secretary for Health be a doctor of 
medicine. Section 3(b) would undo this recent amendment which affords 
the President greater flexibility in appointing, and the Senate in 
confirming, the best-qualified individual. The current statute 
appropriately requires the Under Secretary for Health to be appointed 
solely on the basis of demonstrated ability in the medical profession, 
in health-care administration and policy formulation, or in health-care 
fiscal management, and on the basis of substantial experience in 
connection with VHA programs or programs of similar content and scope.
    Section 3(c) would require the Under Secretary for Health to 
establish a confidential reporting system through which VA employees 
may report quality of care matters to facility and network quality 
assurance officers.
    This provision is not necessary. VA already has in place a 
confidential process for employees to report problems. Every hospital 
is required to advertise this process throughout the facility. 
Employees may also use a variety of other external or internal methods 
to report their concerns. Internally, one may call the Office of the 
Inspector General's Hotline. Outside of VA, methods include: reporting 
a problem under the provisions of the Federal Whistleblower Protection 
Act; and providing information to the Joint Commission (previously the 
Joint Commission on Accreditation of Health Care Organizations). 
Internally, VA employees can provide confidential information to the 
Office of the Medical Inspector; the National Patient Safety Office, 
and to the Office of Compliance and Business Integrity.
    Section 3(d) would require VA to conduct a one-time comprehensive 
review of all current VA policies and protocols for maintaining health 
care quality and patient safety. This would include a review of the 
National Surgical Quality Improvement Program (NSQIP), including an 
assessment of the efficacy of its quality indicators, data collection 
methods, and the frequency of its regular data analyses, and the 
adequacy of allocated resources. Section 3(d) also would require VA to 
submit a report to Congress concerning its findings and recommendations 
within 60 days of the Act's enactment. VA supports this provision.
Section 4. Incentives to Encourage High-Quality Physicians to Serve in 
        the Veterans Health Administration.
    Section 4(a) would amend title 38, United States Code, by adding 
new section 7431A(a) to require the Secretary to carry out a loan 
repayment program for physicians who serve in hard-to-fill positions. 
Under new section 7431A, the Secretary would repay loans covered under 
the section in exchange for not less than three years of service by the 
participating physician in a hard-to-fill position at a VA facility. 
Loans covered by this provision would include any loan described in 10 
U.S.C. Sec. 16302(a)(1)-(4) and any other loans designated by the 
Secretary for which the proceeds were used by the physician to finance 
the education leading to the physician's medical degree.
    Under the program, physicians would have to enter into a written 
agreement with the Secretary under which they agree to perform 
satisfactory service for a specified number of years in a physician 
position at a VA facility specified in the agreement. Physicians 
participating in the program would also have to agree to possess and 
retain such professional qualifications needed to fulfill their service 
obligation. Repayment of loans would be made on the basis of completed 
years of service, but in no case could the amount of repayment exceed 
$30,000 for any one year of service.
    New section 7431A(b) would require the Secretary to conduct a 
tuition reimbursement program for medical students who agree to serve 
for a specified number of years as a VA physician in a hard-to-fill 
position. Specifically, individuals enrolled in a course of education 
leading to board certification would be eligible for this benefit. 
Individuals receiving tuition reimbursement under this program would 
also receive a stipend in the amount of $5,000 for each academic year 
after having entered into an agreement with the Secretary under this 
section.
    In signing the written agreement, a participant would also be 
required to agree to satisfactorily complete the course of education 
leading to board certification as a physician; to become board 
certified as a physician; and upon completion of their education 
program, to perform satisfactorily in the specified physician position 
and to possess and retain the requisite professional qualifications 
throughout their service obligation period. The amount of reimbursement 
payable for one year could not exceed $30,000. Any individual who 
breaches his or her obligations under an agreement would be required to 
repay the funds they received, pursuant to requirements established by 
the Secretary.
    New section 7431A(c) would extend participation in the Federal 
Employees Health Benefits Program (FEHBP) to individuals not otherwise 
eligible for health insurance under chapter 89 of title 5 if they agree 
to serve as a physician in a VA facility in a hard-to-fill position for 
not less than five days per month (of which two days must occur in each 
14-day period). Participating physicians would be able to enroll in one 
of the FEHBP plans on a self or family basis. In carrying out this 
provision, the Secretary would be required to consult with the Director 
of the Office of Personnel Management.
    All of these incentives would be in addition to any other 
recruitment or retention benefits these individuals are eligible for or 
entitled to under the law.
    Section 4(b) of the bill would require the Secretary, to the extent 
practicable, to compel each VA medical facility to seek to establish an 
affiliation with a medical school within reasonable proximity of the 
facility.
    VA does not support section 4 insofar as it would establish a new 
student loan repayment program for VA physicians. Such authority is not 
necessary. VA's Education Debt Reduction Program (EDRP) (authorized by 
38 U.S.C. Sec. Sec. 7681-7683) is sufficient to reimburse recently 
appointed VA physicians for amounts paid on their medical education 
loans. Currently, the Department has authority to award those 
physicians up to $50,824 (tax free) over a period of 5 years to 
reimburse them for amounts paid on their medical school educational 
loans. (The maximum allowed by statute is $44,000, but this is 
automatically increased each calendar year by the amount of the general 
pay increase for Federal employees pursuant to 38 U.S.C. Sec. 7631.) 
Data reflect that the current authority is a highly effective 
recruitment and retention tool. For instance, a study done of EDRP 
award recipients from the first year of program implementation showed 
that 75% of physicians receiving awards in 2002 remained with VHA for 
the duration of their award eligibility, which ended in 2007. In 
addition, we note that the bill would require the Secretary to provide 
this loan repayment benefit rather than making it available as a 
discretionary recruitment and retention tool. Thus, we support 
continued funding of the EDRP but do not believe authority to establish 
a similar loan repayment program is needed.
    VA does not support the provisions of section 4 that would 
establish the tuition reimbursement program for medical students. The 
Administration is currently evaluating the recruitment and retention 
incentives aimed at ensuring the Veterans Health Administration has the 
health professionals needed to deliver high-quality health care to our 
Nation's veterans. Once we have completed our review we will be in a 
better position to evaluate the need for a tuition reimbursement 
program for individuals who are not currently employed by the 
Department.
    We are mindful, however, that VA would not immediately reap 
recruitment benefits under the tuition reimbursement program, After 
graduation, these students must still complete internship and residency 
requirements, and most do not perform their training at the same 
institutions where they obtain their medical degrees. Many students 
additionally pursue fellowships after their residency requirements are 
completed. All in all, these training requirements can extend up to 
seven years post-graduation for some specialties. This does not account 
for the fact that many students change their area of specialty during 
these training periods, thereby extending their overall period of 
training. Thus, there would be a significant lag between the time VA 
makes payments on behalf of particular students and the time those 
students could actually be appointed as physicians to VHA. It is 
because of the difficulty and costs involved in tracking each student 
during his or her training periods that we do not support imposition of 
an annual stipend. Awarding stipends under these circumstances would 
simply not be feasible,
    VA does not support the terms of section 4 that would extend 
participation in the FEHBP to individuals covered by that section. 
While we are greatly interested is in attracting physicians in ``hard-
to-fill'' positions the legislation would provide more favorable 
treatment to this class of physicians than other similarly situated 
employees not only at the Department, but in the Federal Government as 
a whole.
Section 5. Reports to Congress.
    Section 5(a) would require VA to submit annual reports, from 2009 
to 2012, to Congressional veterans affairs committees on the 
implementation and amendments of this Act during the previous fiscal 
year, and VA's recommendations for legislative or administrative action 
to improve the authorities and requirements of the Act, the quality of 
health care, and the quality of VA physicians.
    VA does not support section 5. This section is unnecessary, because 
most provisions of the bill are already being implemented.