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