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Hearing Transcript on U.S. Department of Veterans Affairs Credentialing and Privileging: A Patient Safety Issue.

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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
VIC SNYDER, Arkansas
MICHAEL H. MICHAUD, Maine
STEPHANIE HERSETH SANDLIN, South Dakota
HARRY E. MITCHELL, Arizona
JOHN J. HALL, New York
PHIL HARE, Illinois
MICHAEL F. DOYLE, Pennsylvania
SHELLEY BERKLEY, Nevada
JOHN T. SALAZAR, Colorado
CIRO D. RODRIGUEZ, Texas
JOE DONNELLY, Indiana
JERRY MCNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota

STEVE BUYER,  Indiana, Ranking
CLIFF STEARNS, Florida
JERRY MORAN, Kansas
RICHARD H. BAKER, Louisiana
HENRY E. BROWN, JR., South Carolina
JEFF MILLER, Florida
JOHN BOOZMAN, Arkansas
GINNY BROWN-WAITE, Florida
MICHAEL R. TURNER, Ohio
BRIAN P. BILBRAY, California
DOUG LAMBORN, Colorado
GUS M. BILIRAKIS, Florida
VERN BUCHANAN, Florida

 

 

 

Malcom A. Shorter, Staff Director


SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
HARRY E. MITCHELL, Arizona, Chairman

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

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

 

       

C O N T E N T S
January 29, 2008


U.S. Department of Veterans Affairs Credentialing and Privileging: A patient Safety Issue

OPENING STATEMENTS

Chairman Harry E. Mitchell
        Prepared statement of Chairman Mitchell
Hon. Ginny Brown-Waite, Ranking Republican Member
        Prepared statement of Congresswoman Brown-Waite
Hon. Jerry F. Costello
        Prepared statement of Congressman Costello
Hon. Timothy J. Walz
Hon. Ed Whitfield


WITNESSES

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


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


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

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

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

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

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

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"


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


Tuesday, January 29, 2008
U. S. House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Veterans' Affairs,
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 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 six 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 five 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 Shimkus would join us, please come to the dais.

I would like to now recognize Ms. Brown-Waite for her opening remarks.

[The statement of Chairman Mitchell in the Appendix.]

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 in the Appendix.]

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 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 statement of Congresswoman Brown-Waite in the Appendix.]

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 that 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 two-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 is 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, hard-working 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 statement of Mr. Costello in the Appendix.]

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 five 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 five 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 of 1997 when he started working at the Maytag plant that I was hired into in September of 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, 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 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 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 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 three 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 two-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 statement of Ms. Shank in the Appendix.]

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 five 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 Veterans Integrated Service 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 statement of Dr. Daigh in the Appendix.]

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 on-line 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 got 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 got 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 three 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 Boar