<DOC>
[110th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:43530.wais]
BIOBANKING: HOW THE LACK OF
A COHERENT POLICY ALLOWED
THE VETERANS ADMINISTRATION TO
DESTROY AN IRREPLACEABLE COLLECTION
OF LEGIONELLA SAMPLES
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
----------
SEPTEMBER 9, 2008
----------
Serial No. 110-120
----------
Printed for the use of the Committee on Science and Technology
BIOBANKING: HOW THE LACK OF A COHERENT POLICY ALLOWED THE VETERANS
ADMINISTRATION TO DESTROY AN IRREPLACEABLE COLLECTION OF
LEGIONELLA SAMPLES
BIOBANKING: HOW THE LACK OF
A COHERENT POLICY ALLOWED
THE VETERANS ADMINISTRATION TO
DESTROY AN IRREPLACEABLE COLLECTION
OF LEGIONELLA SAMPLES
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 9, 2008
__________
Serial No. 110-120
__________
Printed for the use of the Committee on Science and Technology
Available via the World Wide Web: http://www.science.house.gov
______
U.S. GOVERNMENT PRINTING OFFICE
43-530 PDF WASHINGTON DC: 2008
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COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
MARK UDALL, Colorado LAMAR S. SMITH, Texas
DAVID WU, Oregon DANA ROHRABACHER, California
BRIAN BAIRD, Washington ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri
JERRY MCNERNEY, California TOM FEENEY, Florida
LAURA RICHARDSON, California RANDY NEUGEBAUER, Texas
DONNA F. EDWARDS, Maryland BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington
JIM MATHESON, Utah MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona VACANCY
CHARLES A. WILSON, Ohio
ANDRE CARSON, Indiana
------
Subcommittee on Investigations and Oversight
HON. BRAD MILLER, North Carolina, Chairman
JERRY F. COSTELLO, Illinois F. JAMES SENSENBRENNER JR.,
EDDIE BERNICE JOHNSON, Texas Wisconsin
STEVEN R. ROTHMAN, New Jersey DANA ROHRABACHER, California
BRIAN BAIRD, Washington DAVID G. REICHERT, Washington
ANDRE CARSON, Indiana PAUL C. BROUN, Georgia
BART GORDON, Tennessee RALPH M. HALL, Texas
DAN PEARSON Subcommittee Staff Director
EDITH HOLLEMAN Subcommittee Counsel
JAMES PAUL Democratic Professional Staff Member
DOUGLAS S. PASTERNAK Democratic Professional Staff Member
KEN JACOBSON Democratic Professional Staff Member
BART FORSYTH Republican Counsel
TOM HAMMOND Republican Professional Staff Member
STACEY STEEP Research Assistant
C O N T E N T S
September 9, 2008
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Brad Miller, Chairman, Subcommittee
on Investigations and Oversight, Committee on Science and
Technology, U.S. House of Representatives...................... 7
Written Statement............................................ 9
Statement by Representative Dana Rohrabacher, Acting Ranking
Minority Member, Subcommittee on Investigations and Oversight,
Committee on Science and Technology, U.S. House of
Representatives................................................ 10
Prepared Statement by Representative Eddie Bernice Johnson,
Member, Subcommittee on Investigations and Oversight, Committee
on Science and Technology, U.S. House of Representatives....... 11
Panel I:
Dr. Janet E. Stout, Director, Special Pathogens Laboratory;
Research Associate Professor, Department of Civil and
Environmental Engineering, University of Pittsburgh
Oral Statement............................................... 12
Written Statement............................................ 14
Biography.................................................... 239
Dr. Victor L. Yu, Professor of Medicine, University of Pittsburgh
Oral Statement............................................... 239
Written Statement............................................ 242
Biography.................................................... 323
Dr. David R. Snydman, Chief, Division of Geographic Medicine and
Infectious Diseases, and Attending Physician in Infectious
Diseases, Department of Medicine, Tufts Medical Center;
Professor of Medicine and Microbiology, Tufts University School
of Medicine
Oral Statement............................................... 323
Written Statement............................................ 326
Biography.................................................... 335
Discussion
The Labeling and Cataloging Characteristics of the Scientific
Collection................................................... 335
The Special Pathogens Laboratory (SPL)......................... 337
Why Was the Special Pathogens Laboratory Closed?............... 339
Transferring the SPL Collection................................ 341
Reasons for Destroying the SPL Collection: Procedural Flaws or
Personality Conflicts?....................................... 342
Panel II:
Dr. Jim Vaught, Deputy Director, Office of Biorepositories and
Biospecimen Research, National Cancer Institute, National
Institutes of Health, U.S. Department of Health and Human
Services
Oral Statement............................................... 345
Written Statement............................................ 347
Biography.................................................... 349
Dr. Janet K.A. Nicholson, Senior Advisor for Laboratory Science,
Coordinating Center for Infectious Diseases, Centers for
Disease Control and Prevention, U.S. Department of Health and
Human Services
Oral Statement............................................... 349
Written Statement............................................ 352
Biography.................................................... 356
Discussion
Scientific Collection Disposal at NCI and CDC.................. 356
Should the SPL Been at the VA?................................. 358
More on Scientific Collection Disposal at NCI and CDC.......... 358
Panel III:
Mr. Michael E. Moreland, Network Director, VA Healthcare--VISN 4,
Department of Veterans Affairs
Oral Statement............................................... 362
Written Statement............................................ 364
Biography.................................................... 376
Dr. Ali Sonel, Associate Chief of Staff, Research and
Development, VA Pittsburgh Healthcare System, Department of
Veterans Affairs
Oral Statement............................................... 376
Written Statement............................................ 378
Biography.................................................... 379
Dr. Mona Melhem, Associate Chief of Staff, Clinical Support
Service Line, VA Pittsburgh Healthcare System (VAPHS),
Department of Veterans Affairs
Oral Statement............................................... 379
Written Statement............................................ 380
Biography.................................................... 381
Dr. Steven H. Graham, Director, Geriatric Research, Educational
and Clinical Center, VA Pittsburgh Healthcare System,
Department of Veterans Affairs
Oral Statement............................................... 382
Written Statement............................................ 383
Biography.................................................... 384
Ms. Cheryl Wanzie, Chief Technologist, VA Pittsburgh Healthcare
System, Department of Veterans Affairs
Oral Statement............................................... 385
Written Statement............................................ 386
Biography.................................................... 387
Discussion
The Catalog for the SPL's Collection........................... 389
The Technical Review's Biohazard Determination................. 390
Fee for Service Testing Policies............................... 393
More on Transferring the SPL Collection........................ 394
More on Reasons for Destroying the SPL Collection: Procedural
Flaws or Personality Conflicts?.............................. 397
Appendix: Additional Material for the Record
Biobanking: How the Lack of a Coherent Policy Allowed the
Veterans Administration to Destroy an Irreplaceable Collection
of Legionella Samples, Staff Report, Subcommittee on
Investigations and Oversight, September 2008................... 400
Exhibit 1........................................................ 433
Exhibit 2........................................................ 434
Exhibit 3........................................................ 437
Exhibit 4........................................................ 439
Exhibit 5........................................................ 442
Exhibit 6........................................................ 445
Exhibit 7........................................................ 446
Exhibit 8........................................................ 482
Exhibit 9........................................................ 483
BIOBANKING: HOW THE LACK OF A COHERENT POLICY ALLOWED THE VETERANS
ADMINISTRATION TO DESTROY AN IRREPLACEABLE COLLECTION OF LEGIONELLA
SAMPLES
----------
TUESDAY, SEPTEMBER 9, 2008
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:00 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brad
Miller [Chairman of the Subcommittee] presiding.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
hearing charter
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
Biobanking: How the Lack of
a Coherent Policy Allowed
the Veterans Administration to
Destroy an Irreplaceable Collection
of Legionella Samples
tuesday, september 9, 2008
10:00 a.m.-2:00 p.m.
2318 rayburn house office building
Purpose
On December 4, 2006, a set of biological materials that was a
primary support for work on Legionella, the bacterium causing
Legionnaire's Disease, was destroyed at the Veterans Administration
(VA) Medical Center in Pittsburgh, Pennsylvania. This occurred even as
the process to transfer the collection to a University of Pittsburgh
laboratory for further use in research was underway. It was also the
last act of an acrimonious process that had seen the closure of its
host, the Special Pathogens Laboratory (SPL), some four months earlier.
The closure of this lab puts all hospital patients, especially the
elderly, severely sick children--all those with compromised immune
systems--at greater risk because this was one of the top hospital
infection laboratories in the Nation.
The purpose of this hearing is to make public the findings of a
Subcommittee investigation of this case. The Subcommittee's findings
highlight the need for improved policies on biospecimen management.
Witnesses
Panel I
Dr. Victor Yu, Professor of Medicine, University of Pittsburgh
Dr. Janet Stout, Director, Special Pathogens Laboratory
The collection of materials destroyed at Pittsburgh was the work of
Doctors Yu and Stout, who have, during the last three decades, become
world-recognized experts in identifying Legionnaire's Disease. Dr.
Stout is widely recognized for her work in developing methods to keep
Legionella out of water supplies at hospitals and nursing homes. Dr. Yu
has an international reputation for his work on infectious diseases in
hospitals, of which Legionnaires' Disease is a common type. Dr. Stout
had a meeting scheduled the morning after the destruction of the
collection (December 5, 2006) to remove personal identifying data from
the specimens, a necessary step prior in the transfer process.
Dr. David Snydman, Chief, Division of Geographic Medicine and
Infectious Diseases, and Attending Physician in Infectious Diseases,
Department of Medicine, Tufts Medical Center
Dr. Snydman has collaborated with Dr. Yu on infectious disease
research, and will provide an expert perspective on the value of the
lost materials. He was also instrumental in bringing the loss of the
collection to the attention of the scientific community, and calling
for an independent review of the actions by administrators at the
Veterans Administration Pittsburgh Healthcare System (VAPHS).
Panel II
Dr. Jim Vaught, Deputy Director, Office of Biorepositories and
Biospecimen Research, National Cancer Institute (NCI)
Dr. Vaught has been directly involved in the development of
biospecimen management policies in his position at the NCI, helping to
develop the ``best practices'' guide published by the Institute in June
2007. He was assigned to the task force that assisted in a review and
update of National Institutes of Health (NIH) policies in 2006. He has
also been participating as an NIH representative on an Office of
Science and Technology Policy working group on scientific collections
that is finishing a draft report on the state of all federal scientific
collections.
Dr. Janet K.A. Nicholson, Senior Advisor for Laboratory Science,
Coordinating Center for Infectious Diseases, Centers for Disease
Control and Prevention (CDC)
CDC is a federal agency that faces questions of biospecimen
management constantly, as the collection of those materials is critical
to the identification of disease. Dr. Nicholson will testify on her
agency's methods for dealing with the issues raised by the collection
and proper management of biospecimens. She will also discuss the
policies governing operations at the CDC's major central repository,
CASPIR.
Panel III
Michael Moreland, Director, Veterans Integrated Services Network 4,
Department of Veterans Affairs
At the time the collection was destroyed, Mr. Moreland was the
Director of the VAPHS (he was in the process of being promoted to lead
the VA's regional office). Mr. Moreland oversaw the decision to close
the SPL and instituted a Board of Investigation to examine allegations
of financial impropriety against Dr. Yu. He is alleged, though there is
no written record, to have personally ordered the destruction of the
collection.
Dr. Mona Melhem, Associate Chief of Staff and Vice President, VAPHS
Clinical Support Service Line
Dr. Melham supervises the clinical activities at the Pittsburgh VA
Healthcare System, which include the Clinical Microbiology Laboratory
at the hospital. It was Dr. Melhem's direct order that led to the
abrupt destruction of the collection at the Special Pathogens
Laboratory on December 4, 2006.
Dr. Ali Sonel, VAPHS Associate Chief of Staff (Research)
In his position, Dr. Sonel is responsible for the management and
conduct of research by staff at VAPHS. Dr. Sonel assumed the position
on September 1, 2006, soon after the SPL was closed. He was overseeing
efforts to assist Dr. Stout to move the collection from the SPL to the
Department of Microbiology and Molecular Genetics of the School of
Medicine at the University of Pittsburgh when the collection was
destroyed without his knowledge.
Dr. Steven Graham, Director, VAPHS Geriatric Research, Education and
Clinical Centers
Dr. Graham preceded Dr. Sonel as head of research at VAPHS, and was
involved in the process that led to SPL's closure. He served as a
member of the Board of Investigation convened by Mr. Moreland. He was
cited by Dr. Melhem as having approved the destruction of the
collection, but has denied it.
Ms. Cheryl Wanzie, VAPHS Chief Technologist
Ms. Wanzie supervises the technical operations of the VAPHS
Clinical Microbiology Laboratory. She was one of those receiving Dr.
Melhem's order to destroy the collection on December 4, and was in the
Laboratory as the freezers were emptied into biohazard bags.
Background
On December 4, 2006, employees of the VAPHS' clinical microbiology
laboratory, were ordered to destroy the collection of Legionella and
other disease isolates and also water samples containing the Legionella
bacteria that had been accumulated by Dr. Yu and Dr. Stout over the
decades of their research on this disease. The order was given by Dr.
Melhem at the same time Dr. Sonel was actively working to transfer the
collection to a laboratory at the University of Pittsburgh for use in
further research by Dr. Yu and Dr. Stout.
At that time, the Special Pathogens Laboratory had been closed for
almost five months, and Dr. Yu was no longer with the VAPHS.
The destruction took place outside of any previous process that had
been used to determine the disposition of biospecimens left behind by
former researchers and without the knowledge of Dr. Sonel or the
Research Compliance Committee, which would normally been involved. The
collection was the life's work of Dr. Yu and Dr. Stout, and no one from
the VAPHS has been able to provide a credible reason for such a
precipitous act.
Building the Better Biobank
Collections such as the Legionella collection are more and more
common as researchers study the evolution of both disease strains and
treatment. The improving capability of tools for biological analysis is
allowing researchers to make greater strides in understanding the
workings of human biology at ever finer detail. Coupled with ever more
powerful computers, this allows studying amounts of data that could
never have been contemplated in the past. With the completion of the
``draft'' of the human genome, so-called ``personalized medicine''
appeared on the horizon: medical treatments could be devised to meet a
patient's unique condition.
These changes are reflected in the development of biobanks: places
where traditional human biospecimens such as blood and tissue are
matched to databases with medical records, genomic sequence data and
other information. Bringing these together helps with the
identification of disease-causing genes or genetic variants. It can
find connections between outbreaks of infection and factors in the
environment. Targets for new therapies can be found. The SPL collection
was something of a prototype biobank, and much of its value resided in
the ability to match a particular biospecimen to its clinical history.
That the collection included biospecimens extending back more than two
decades also allowed comparative study to learn how organisms were
changing in response to efforts to control or eradicate them.
One of the principal values of a properly-run biobank is the
control of quality, allowing researchers to be confident that the
information they use (and the results they obtain) are accurate. This
requires rigorous control over biospecimens from the moment of
collection and equally careful handling of the patient-specific medical
information associated with it. Today's hearing is concerned, not just
with the events at the VAPHS, but with the collection management policy
aspects related to the physical biospecimens.
The Federal Government has supported, either with work at agencies
like the National Institutes or Health the Centers for Disease Control
and Prevention or by external research grants, the collection of
millions of biospecimens. Many are in freezers in thousands of
disparate laboratories, mostly of interest to a particular researcher
for a specific project. It is not easy to find firm policy governing
these valuable materials. The loss of the SPL collection, where
materials of continuing scientific value were destroyed on the order of
just one person, highlights the need to bring greater discipline to
biospecimen management.
There have been scattered efforts to address the need for improved
policies in biospecimen management. The hearing today will discuss
efforts at NIH and CDC to update their policies to serve as models for
discussion. This includes the question of destroying materials; while
no scientist likes to lose a piece of data, it sometimes is necessary
when freezers fill up or the collection's champion retires and no one
is interested in carrying on that line of work. Best practice today
argues that efforts should be made to find an alternative home for
those materials, a process that had been successfully underway with the
SPL Legionella collection. It also expects that there will be some
evaluation of the continuing value of the materials before deciding on
destruction. The biospecimens at the heart of tomorrow's biobanks need
robust protection, unlike the fate of SPL's collection.
The SPL Environment
The 1976 outbreak of Legionnaires' Disease at the Philadelphia
American Legion convention immediately raised concerns at the Veterans
Administration, as it attacked precisely the same populations in VA
hospitals across the country. VAPHS did much to lead the effort to find
out about the disease. The Clinical Microbiology Laboratory found a way
to grow Legionella bacteria in laboratories, and Doctors Yu and Stout
traced the source of infection to water systems. The Special Pathogens
Laboratory was originally established as a focus for continued
Legionella studies and testing for both VA and non-VA health care
facilities. The work of Doctors Yu and Stout figured prominently in a
review of Legionnaires' Disease risk at VA facilities by the
Department's Inspector General last year and the institution of a new
protocol.
SPL's expertise was shared with other VA facilities and outside
entities. Although initially funded by the VA's central office, in
keeping with VA policy in the mid-1990s, Dr. Yu proposed to recover
testing costs by billing for services. This was approved, and the
billing system was set up through the Veterans Research Foundation of
Pittsburgh. Congress had allowed the creation of these non-profit
entities to manage outside contributions for research at VA facilities.
The revenues were used to pay the salaries of Lab employees (except for
Dr. Stout, who was a VA microbiologist). By the time the SPL was
closed, it was billing about $500,000 per year. For the most part, so
far as documents show, there was little concern about the Lab's
activities at the Foundation until 2006.
While the decision to close the SPL is not the focus of this
hearing, it cannot be completely divorced from the discussion. The
chaotic events of July 2006, during which Dr. Yu was told to close the
lab in two days, then received a 10-day extension, after which the
doors were locked and access denied, confused the status of the
Legionella collection. It became clear that there were gaps in the
system of research oversight at the VAPHS. Some administrators assert,
based on incomplete, largely post-hoc investigations, that these
biospecimens were not collected as part of approved research protocols,
nor were they properly maintained and identified--therefore they had no
scientific value despite their role in numerous peer-reviewed articles
and VA's treatment practices. Doctors Yu and Stout firmly state that
they had appropriate approvals and that the collection was properly
cataloged.
But what is evident is that the research structure at the VAPHS--
which was supposed to have been in charge of the collection, had
opposed its destruction and was ready to transfer it to Dr. Yu--was
deliberately kept out of the loop. What is also evident is that
administrators at a major VA hospital system had allowed personal
animosities and goals to overcome its own processes. No federal health
facility should be allowed to function in this manner. A Subcommittee
staff report describes the situation in greater detail.
Chairman Miller. Good morning. This hearing will come to
order. Today's hearing is ``Biobanking: How the Lack of a
Coherent Policy Allowed the Veterans Administration to Destroy
an Irreplaceable Collection of Legionella Samples.''
The Subcommittee staff for the Investigation and Oversight
Subcommittee conducted an extensive investigation into the
handling of an irreplaceable collection of Legionella samples
at the Veterans Affairs Pittsburgh Healthcare Clinic. The
purpose of this hearing is to make public the findings of the
Subcommittee's investigation into this case and to highlight
the need for a uniform national policy on biospecimen
management.
On December 4, 2006, late in the afternoon, two employees
of the clinical microbiology laboratory at the Veterans Affairs
Pittsburgh Healthcare Clinic, the VAPHS, were ordered by Dr.
Mona Melhem, the Associate Chief of Staff for Clinical
Services, to go to the Special Pathogens Laboratory and destroy
the research collection of Dr. Victor Yu and Dr. Janet Stout.
Dr. Melhem said her orders came from Michael Moreland, then the
system's Director.
The two employees commandeered the help of three other
employees, and within three hours a collection that had taken
three decades to build was gone. Drs. Yu and Stout are
international experts in the detection, treatment and control
of Legionella, a bacterium that causes a kind of severe
pneumonia called Legionnaires' disease, and their laboratory
was internationally acclaimed. Dr. Yu was known for his work on
other infectious pneumonias and antimicrobial resistance.
According to Dr. David Snydman of Tufts Medical Center, one of
our witnesses today, this collection was used to develop new
diagnostic tests and therapies and to study resistance and
mechanisms of disease transmission.
The destruction of the research collection was the
culmination of an acrimonious series of events that included
the closing of the nationally acclaimed laboratory, the firing
of Dr. Yu and the attempted firing of Dr. Stout.
As an impartial audience--there is no real partisanship to
any of this--the most troubling part of the story is that the
destruction of this one-of-a-kind collection occurred less than
an hour after Dr. Melhem learned that formal steps were being
taken the following day to transfer the collection to the
University of Pittsburgh, where Drs. Yu and Stout were then
affiliated so their research could go on, and the destruction
of this collection occurred after Dr. Melhem made a false
statement to the system's Chief of Staff and the head of the
research office telling him that the collection could not be
transferred because it had already been destroyed on the orders
of the medical center's Director. That false statement kept the
head of the research office from effectively intervening to try
to save the collection.
Months of investigation by the Subcommittee have not
revealed any credible reason for the destruction of the
collection. Dr. Melhem said that a former research official had
approved the destruction months before. That official denies
giving such approval. She also claims that the decision was
made in July without ever informing Dr. Stout or Dr. Yu, both
of whom were then still on staff. Dr. Moreland can't remember
giving her such orders on December 4 and seems unclear about
his understanding of the difference between the research
specimens that we are concerned with today and clinical
specimens that were being processed by the laboratory on the
day that it closed. Both Dr. Melhem and Mr. Moreland are now
taking the position that the collection wasn't really a
research collection and did not have to be preserved. This is
despite the fact that dozens of peer review papers have come
out of the laboratory in its 25 years of existence, and
statements made to Dr. Yu that he would be able to continue his
research, even if the lab closed.
Mr. Moreland's testimony came in late yesterday. The
Subcommittee has made two very comprehensive document requests
concerning the closure of the Special Pathogens Laboratory and
the destruction of its research collection, and we received
many documents, voluminous documents, but in his testimony, Mr.
Moreland refers to a technical review regarding biohazards at
the lab, disposal acts done in July of 2006, and a December
2006 determination that not a single one of the samples in
question were collected, or was collected, as part of any
previously approved research effort. The Committee has never
received any documentation of any of those assertions. Either
they do not exist, the documents do not exist, or they have not
been provided, but in any case, the testimony is very
troubling.
Mr. Moreland and other witnesses from the Pittsburgh VA
should remember that their testimony today is under oath and it
is simply not credible that important technical decisions were
made entirely based upon conversations with no documentation.
I cannot imagine the circumstances under which a federal
health agency official would unilaterally order the destruction
of a human tissue collection without receiving the approval of
the agency's research office and the Research Compliance
Committee. I cannot imagine why that official would apparently
make false statements during the destruction to keep the
associate director for research at the center in the dark until
the destruction was complete. It stuns me that in the time
since those actions, neither Pittsburgh nor national VA
officials have taken formal action to discipline the managers
involved in this case or establish clear policy on the
destruction of biomedical collections to make sure that this
will never happen again.
All of us may pay a price for this conduct, veterans most
of all, because the Nation lost one of its leading research
labs on hospital infectious diseases, and while the researchers
can relocate and start their work again, the research samples
can never be wholly reconstituted. Those who are in hospitals,
the elderly, severely sick children or anyone else with
compromised immune systems are those most at risk.
The work of Dr. Yu and Dr. Stout cannot be recovered
entirely. However, we can protect the work of thousands of
other professionals at the VA and other federal agencies or
institutions that result in the collection of biological
samples, biological collections funded by taxpayer money. Those
collections should not be subject to similar mishandling simply
at the caprice of a powerful administrator. It is time for the
Office of Science and Technology Policy to start an interagency
effort to create a core set of policies for the handling,
maintenance and disposition of such specimens, and I do intend
to introduce that legislation shortly.
[The prepared statement of Chairman Miller follows:]
Prepared Statement of Chairman Brad Miller
The Subcommittee staff of the Subcommittee on Investigations and
Oversight conducted an extensive investigation into the handling of an
irreplaceable collection of Legionella samples at the Veterans Affairs
Pittsburgh Healthcare System. The purpose of this hearing is to make
public the findings of the Subcommittee investigation of this case and
to highlight the need for a national uniform policy on biospecimen
management.
On December 4, 2006--late in the afternoon--two employees of the
clinical microbiology laboratory at the Veterans Affairs Pittsburgh
Healthcare System (VAPHS) were ordered by Dr. Mona Melhem, the
Associate Chief of Staff for clinical services, to go to the Special
Pathogens Laboratory and destroy the research collection of Dr. Victor
Yu and Dr. Janet Stout. Dr. Melhem said her orders came from Michael
Moreland, then the system's Director.
The two employees joined by three others took less than three hours
to bag up a biomedical sample collection that represented almost three
decades of research by Dr's Yu and Stout. It was bagged, burned and
gone. Drs. Yu and Stout are international experts in the detection,
treatment and control of Legionella, a bacterium which causes a type of
severe pneumonia called Legionnaires' disease, and their laboratory was
internationally acclaimed. Dr. Yu was also known for his work on other
infectious pneumonias and antimicrobial resistance. According to Dr.
David Snydman of Tufts Medical Center and one of our witnesses today,
this collection was used to develop new diagnostic tests and therapies
and to study resistance and mechanisms of disease transmission.
The destruction of the research collection was the culmination of
an acrimonious series of events that included the closing of the
nationally acclaimed laboratory, the firing of Dr. Yu, the system's
long-time Chief of Infectious Disease, and the attempted firing of Dr.
Stout.
As an impartial audience, the most troubling part of this story is
that the destruction of this one-of-a-kind collection occurred less
than an hour after Dr. Melhem learned that formal steps were being
taken, on the following day, to transfer the collection to the
University of Pittsburgh, where Drs. Yu and Stout were affiliated. And
the destruction of this collection occurred after Dr. Melhem made a
false statement to the system's Chief of Staff and the head of the
research office, telling them that the collection could not be
transferred because it had already been destroyed on the orders of the
medical center's Director. That false statement kept the head of the
Research Office from effectively intervening to try to save the
collection.
I will leave many details to my written statement, but summarize by
saying months of investigation by the Subcommittee have not revealed
any credible reason for this rash and malicious act. Dr. Melhem says
she received direction to destroy the collection; the people she cites
deny it or don't recall doing so. There is a claim this isn't
``research'' collection, despite the fact that dozens of peer-reviewed
papers have come out of the laboratory in its 25 years of existence,
and statements made to Dr. Yu in July that he would be able to continue
his research even if the lab closed.
The policies for collection management at the Pittsburgh VA--and
perhaps the entire VA system--are unclear, and the organizations in
place to oversee research appear to have been short-circuited. We also
found that there were years of neglect by the board of the Veterans
Research Foundation of Pittsburgh, which was handling the Special
Pathogens Laboratory's funds, but paid little attention to it until a
few months before its abrupt decision to close the lab. The
institutional failure to establish and follow clear procedures spilled
over into the decision-making process for closing the lab. It appeared
that the most important thing to the Pittsburgh VA hierarchy in the
summer of 2006 was to close the lab and rid itself of Dr. Yu and Dr.
Stout by whatever means necessary.
I want to make one comment about Mr. Moreland's testimony which
came in late yesterday. The Subcommittee has made two very
comprehensive document requests concerning the closure of the Special
Pathogen Laboratory and the destruction of its research collection, and
we have received many documents. Yet in his testimony, Mr. Moreland
makes reference to a ``technical'' review regarding biohazards at the
lab; disposal acts done in July of 2006; and a December 2006
``determination'' that not a single one of the samples in question were
collected as part of any previously approved research efforts. The
Subcommittee has never received any documentation of any of these
claims. Either they do not exist or they have not been provided, but
either way, this testimony is very troubling.
Mr. Moreland and other witnesses from the Pittsburgh VA should
remember that they are giving their testimony under oath. The
Subcommittee will take it very seriously if they cannot provide
documentation of their statements.
Scientists from several other agencies and institutions have been
contacted by the Committee staff and, while their own policies may be
based more on habit and common sense than actual guidance, all of them
indicated that such an act would not have occurred in their agency. A
much more common practice is to determine if any other researchers at
the institution are interested in the collection and, if not, ask the
departing researcher if he or she wants to take the collection. If no
one wants the collection and its long-term value to the originating
institution is deemed minimal, it may be offered to outside researchers
who have worked in the field. If there is absolutely no interest, the
collection is destroyed. The Pittsburgh VA's actions were so out of the
norm that more than 200 infectious disease researchers have called for
an independent investigation.
I cannot imagine the circumstances under which a federal health
agency official would unilaterally order the destruction of a human
tissue collection without receiving the approval of the agency's
research office and the Research Compliance Committee. I cannot imagine
why that official would, apparently, make false statements during the
destruction to make it keep the Associate Director for Research at the
Center in the dark until the destruction was complete. It disappoints
me that in the time since those actions, neither Pittsburgh nor
national VA officials have taken formal action to discipline the
managers involved in this case or establish clear policy on the
disposition of biomedical collections to make sure that this could
never occur again.
The work of Dr. Yu and Dr. Stout cannot be recovered. However, we
can protect the work of thousands of other professionals at the VA and
other federal agencies or institutions that result in the collection of
biological collections funded by taxpayer money. These collections
should not be subject to similar mishandling simply because they run
afoul of a powerful administrator. It is time for the Office of Science
and Technology Policy to start an interagency effort to create a core
set of policies for the handling, maintenance and disposition of such
specimens. I intend to introduce that legislation shortly.
Chairman Miller. I now yield to my distinguished colleague,
Representative Rohrabacher, for an opening statement.
Mr. Rohrabacher. I thank you very much, Mr. Chairman, and I
am sorry that I have a bit of a cold today. Maybe I could seek
advice from the panel on what to do. If you have one of those
things to cover my face, that might be an appropriate
situation.
So often here in Washington, D.C., when we take a look at a
serious problem, we find that politics and bureaucracy has
really screwed things up, and this may or may not be the case
here. In this case, we might be looking at a situation where
individuals were wrong. People who held power made wrong
decisions, and people who make wrong decisions should be held
accountable or it will not encourage other people who hold
positions of authority to take their job as seriously as their
jobs dictate. If it's not an individual flaw or a situation
where we have a situation where an individual has made wrong
decisions, we may find in this case that the system itself is
flawed.
I want to congratulate the Chairman for the work he has
done on this issue to see if we can come down to find out
exactly what is at the heart of this issue and what caused this
to happen and what can be done to correct the situation. We
need to hear the details to see if it is a flaw in the system,
if it can be corrected, and if it is a personnel situation
where bad decisions were made for whatever reason, that those
people are held accountable. Our policy on biobank issues
certainly deserves our attention in relation to looking over
this particular issue.
I would suggest that we should be very careful, however, to
make sure that when we are proposing changes or what should be
the reaction of the government to this incident that we be
careful not to introduce politics and bureaucracy in a negative
way into a system that may well be making mistakes because
people within the system just made flawed decisions. Maybe
people were kept in positions of authority for too long, maybe
perhaps a situation where the people themselves did not have
the proper oversight, so we really have to take a look where an
individual, he or she did something wrong but we can't use that
as an excuse to alter the system in a way that might make it
less effective in the future if we haven't targeted the reforms
in the right way.
So I am very open-minded to this, and if we can make it
better, we will, and as the Chairman stated, there is no
politics in a situation like this. We work together to try to
see what we can come up with that will correct a flawed
situation or hold people accountable for the decisions they
have made.
With that, thank you very much, Mr. Chairman. I look
forward to the hearing.
Chairman Miller. Thank you, Mr. Rohrabacher.
Any additional opening statements submitted by Members will
be included in the record.
[The prepared statement of Ms. Johnson follows:]
Prepared Statement of Representative Eddie Bernice Johnson
Mr. Chairman, the flippant destruction of a biobank of Legionella
concerns me greatly, as a nurse.
As you may know, this bacterium causes a serious lung infection. It
was so named in 1976 when many people attending a convention of the
American Legion became sickened by it.
The Centers for Disease Control report that between 8,000 and
18,000 people are hospitalized each year with Legionnaires' disease in
the United States. Elderly people are especially vulnerable to it.
Legionnaires' disease can have symptoms like many other forms of
pneumonia, so it can be hard to diagnose at first. Signs of the disease
can include: a high fever, chills, and a cough.
The disease can be very serious and can cause death in up to five
percent to 30 percent of cases.
The Legionella bacteria are found naturally in the environment,
usually in water.
The bacteria grow best in warm water, like the kind found in hot
tubs, cooling towers, hot water tanks, large plumbing systems, or parts
of the air-conditioning systems of large buildings.
People get Legionnaires' disease when they breathe in a mist or
vapor (small droplets of water in the air) that has been contaminated
with the bacteria.
Mr. Chairman, I understand that in 2006, a set of biological
specimens was destroyed at the Veterans Administration Medical Center
in Pittsburgh, Pennsylvania.
This represented a hostile act that was part of the shut-down of
the lab at the VA Medical Center.
The collection was intended to be transferred to the University of
Pittsburgh, so that important research on Legionnaire's disease could
continue.
This recklessness is a disservice to the American public and is an
ignorant waste of taxpayer dollars.
In addition, the closure of the Special Pathogens Laboratory (SPL)
is detrimental to public health because the lab was one of the top
hospital infection laboratories in the Nation.
The circumvention of appropriate decision-making processes will
have the ultimate effect of harm to public health.
I want to commend the Chairman and staff for seeking the
perspectives of scientists who were in the Special Pathogens
Laboratory.
Researchers will be able to underscore the value of the specimens
that were discarded, and the consequences of that action on our
nation's public health.
Thank you, Mr. Chairman. I yield back.
Panel I:
Chairman Miller. It is now my pleasure to introduce our
first panel of witnesses today. First is Dr. Victor Yu, a
professor of medicine at the University of Pittsburgh. Dr.
Janet Stout is the Director of the Special Pathogens
Laboratory. Dr. David Snydman is the Chief of the Division of
Geographic Medicine and Infectious Diseases and attending
physician in infectious diseases at the Department of Medicine
at the Tufts Medical Center. I suspect that is not what he says
at cocktail parties that his job is.
You will all have five minutes for your oral testimony.
Your written testimony will be included in the record. When you
complete your testimony, we will begin with questions. Each
Member will have five minutes to question the panel. It is the
practice of the Committee, because we are an Investigations and
Oversight Subcommittee, to take testimony under oath. Do any of
you have any objection to being sworn in, to swearing an oath?
All the witnesses nodded their heads that they did not. The
Committee also provides that you may be represented by counsel.
Are any of you represented by counsel at today's hearing? All
three of witnesses also nodded their heads no. If you would now
please stand and raise your right hand. Do you swear to tell
the truth and nothing but the truth? All three of the witnesses
said that they did so swear.
Actually, if we could begin with Dr. Stout today. Dr.
Stout, could you begin?
STATEMENT OF DR. JANET E. STOUT, DIRECTOR, SPECIAL PATHOGENS
LABORATORY; RESEARCH ASSOCIATE PROFESSOR, DEPARTMENT OF CIVIL
AND ENVIRONMENTAL ENGINEERING, UNIVERSITY OF PITTSBURGH
Dr. Stout. Thank you. Members of the Committee, first I
want to thank you for holding the hearing. I am Dr. Janet
Stout. I received both my Master's and Ph.D. degrees from the
University of Pittsburgh Graduate School of Public Health. I am
internationally recognized as an authority on Legionnaires'
disease. I have authored book chapters and more than 80
publications in peer-reviewed journals. I spent 25 years at the
Pittsburgh VA Medical Center as a microbiologist in the Special
Pathogens Laboratory. My scientific achievements include
identifying the drinking water, not air conditioning, as the
real source for hospital-acquired Legionnaires' disease.
The VA Special Pathogens Laboratory was part of the VA
microbiology laboratory and served as a national Legionella
reference laboratory until its closure in 2006. The
accomplishments of this laboratory are many. The collection of
isolates and specimens housed in this collection played a major
role in these accomplishments. From 1979 to 2006, we banked
over 8,000 specimens from our studies on Legionnaires' disease
and other infections. These specimens included isolates of
Legionella and thousands of serum, respiratory and urine
samples.
The role of this collection of microorganisms in our
discoveries can be summarized as follows. We showed that
Legionnaires' disease was acquired from hospital drinking water
systems. Legionella isolates in our collection proved this
association for hospitals across the United States. Our
laboratory developed new and better ways to detect and treat
this disease. Every antibiotic and Legionella diagnostic test
in use today was tested in our laboratory. Our collection
allowed new tests to fulfill FDA requirements for approval.
These specimens were destroyed.
We developed advanced environmental and clinical methods
which were not used by many laboratories. Less-experienced labs
gave incorrect results and bad advice, placing patients at
risk. For example, in 2005, one laboratory failed to diagnose a
large outbreak of Legionnaires' disease in a nursing home.
Using our collection, we showed that the urine antigen test
used by that laboratory gave false negative results. The
specimens that allowed us to make this discovery were
destroyed. I therefore caution the Pittsburgh VA, who is
performing Legionella testing for free for other VA
laboratories, that this testing is being done by untrained and
inexperienced technicians.
Our collection included isolates from every hospital using
our laboratory. Having these isolates available in the future
would establish whether or not the hospital was the actual
source of infection or the patient acquired the disease
elsewhere. These isolates were destroyed.
We demonstrated the development of resistance by Legionella
to a commonly used water disinfection method. This observation
was only made possible by comparison of historical isolates to
present-day isolates. The specimens that allowed us to make
this discovery were destroyed.
We showed that the risk of illness to patients could be
predicted. Other scientists have requested our specimens for
study in their laboratories to study disease-causing traits and
evaluate new antibiotics. These specimens are no longer
available to the scientific community for study. They were
destroyed.
Our research was supported by the VA Merit Review System,
the U.S. Environmental Protection Agency and industry. The VA
Merit Review study was an IRB-approved study involving 20 VA
institutions across the United States. The results of this
study were published in 2007 in the journal Infection Control
and Hospital Epidemiology.
We also showed that patients get Legionnaires' disease from
drinking water in their own homes. This was an EPA-funded, IRB-
approved study. All of the isolates and specimens collected
during the Merit Review and EPA studies were destroyed.
We collected these isolates for research purposes and the
research was approved. Dr. Yu will provide the Committee with
documentation to support this point.
What did we do to save the collection? I wasn't concerned
about the transfer of the collection from the VA because I knew
other VA investigators had transferred their collections when
they left the VA. The research office even told us that they
had recently gone through this process with one of their VA
physicians. In August 2006, we first expressed our concern for
the safety of the collection. In an e-mail from Dr. Yu to Dr.
Graham, Dr. Yu stated, ``I fear the vindictiveness of the
Administration may imperil this irreplaceable collection.'' We
were reassured by Dr. Graham when he responded, ``Of course I
don't want to see valuable specimens destroyed.'' In response,
Dr. Yu and I obtained the assistance of Dr. Tim Mietzner at the
University of Pittsburgh and we requested the transfer of these
materials to his laboratory at the University of Pittsburgh.
From August through December 2006, I actively engaged the
research office in my attempt to transfer the collection to the
university. VA administration was copied on these e-mails. I
was never asked by anyone to provide any information on the
contents of the collection and there was never any indication
that the disposition of the collection was in question or that
the collection was in danger of being destroyed.
On December 4, 2006, Dr. Sonel notified the VA
administration that I was to meet with the research compliance
officer in the laboratory the next day to begin the transfer.
Later on that same day, Dr. Sonel informed me via an e-mail
that he was asked by the front office to put this process on
hold. He said he or someone from the front office will be
contacting me about this request. No one from the VA ever
contacted me and I did not know that the collection had been
destroyed. Only after an inquiry from Senator Specter and Rick
Earl, a reporter, did the VA publicly admit to destroying the
collection. For me as a scientist, and for veterans and the
American public, the loss is incalculable.
In protest, a petition was published in the April issue of
Clinical Infectious Diseases and signed by over 250 scientists
worldwide. They requested that an investigative committee
review the actions of the Pittsburgh VA Healthcare System
regarding the closure of the laboratory and the destruction of
the scientifically valuable collection of microorganisms.
The petition signatories and I thank you for your time
today and your effort in fulfilling this request. Thank you.
[The prepared statement of Dr. Stout follows:]
Prepared Statement of Janet E. Stout
Members of the Committee, first I want to thank you for holding
this hearing.
I am Dr. Janet Stout. I have a Ph.D. in infectious disease
microbiology and I am a Research Associate Professor at the University
of Pittsburgh Department of Civil and Environmental Engineering. I
received both my Masters and Ph.D. degrees from the University of
Pittsburgh, Graduate School of Public Health.
I am internationally-recognized as an authority on Legionnaires'
disease. I have authored book chapters and more than 80 publications in
peer-reviewed journals including the New England Journal of Medicine,
the Journal of the American Medical Association (See Stout CV in
Section 8 of written testimony).
I have lectured on Legionnaires' disease at national microbiology,
infection control and engineering conferences, at the European Working
Group on Legionella Infection and in 2009, I will speak at the
International Legionella Symposium in Paris France.
I spent 25 years at the Pittsburgh VA Medical Center as a
microbiologist in the Special Pathogens Laboratory.
My scientific achievements include identifying drinking water--not
air conditioning--as the real source for hospital-acquired
Legionnaires' disease. This finding was a major paradigm shift and
unraveled the epidemiology of hospital-acquired Legionnaires' disease,
and was published in the New England Journal of Medicine and in the
Lancet.
I have worked with State and local public health agencies in
developing guidelines for the prevention of hospital acquired
Legionnaires' disease. This work provided the foundation for guidelines
for the Health departments in the States of Maryland and New York, and
the countries of Spain, Italy, Taiwan, the Netherlands, Denmark, and
France, and the VA Healthcare System.
In 2005, I was asked by the VA Medical Inspector General to assist
him in devising a new VA Legionella prevention Directive, which was
issued nationwide in February 2008.
The Special Pathogens Laboratory
The VA Special Pathogens Laboratory was part of the VA microbiology
laboratory and served as a national reference laboratory until its
closure in 2006. As a microbiologist in this unit, I performed clinical
and reference laboratory testing for VA and non-VA institutions (See
Stout position description Section 5 of written testimony).
I was among the many students, physicians and scientists that
worked in this ``Center of Excellence'' and whose accomplishments were
highlighted in the VA ``Vanguard'' in 1996, on the occasion of the 20th
anniversary of the discovery of Legionnaires' disease (See ``Medical
Advances May/June 1996).
The collection of isolates and specimens housed in this laboratory
played a major role in those accomplishments and resulted in more than
200 publications on Legionnaires' disease.
The Collection
A scientifically valuable collection of microorganisms was
destroyed. In order to fully understand the impact of this action, I
will describe its scientific relevance and how we were the guardians of
the collection until its destruction in 2006.
I was trained to catalogue isolates and specimens, place them in
plastic freezer vials at -70<SUP>+</SUP>C and maintain a detailed
record so others could retrieve the isolates for future study (See
Section 4 of written testimony--Bacterial Stock Maintenance). I
maintained the collection in the Special Pathogens Laboratory at the VA
Medical Center in Pittsburgh, PA. Information about the isolates was
recorded in a log book and typed into an electronic file on the lab
computer.
From 1979 to 2006, we banked over 8000 specimens from our studies
on Legionnaires' disease and other infections. The specimens included
isolates of Legionella, Staphylococci, Pseudomonas, Klebsiella,
Enterococci, Streptococci and Candida species and thousands of serum,
respiratory and urine samples. They were all were destroyed.
The role of this collection of microorganisms in our discoveries
can be summarized as follows:
1. We showed that Legionnaires' disease was acquired from
hospital drinking water systems. Legionella isolates in our
collection proved this association for hospitals in Pittsburgh
and across the U.S.
2. Our laboratory developed new and better ways to detect and
treat this disease. Every antibiotic and Legionella diagnostic
test in use today was tested in our laboratory. Our collection
allowed new tests to fulfill FDA requirements for approval (See
requests from scientist in Section 7 of written testimony).
These specimens were destroyed.
3. We developed advanced environmental and clinical methods.
Less experienced laboratories often gave incorrect results and
advice, placing patients at risk. For example, in 2005 one
laboratory failed to diagnose a large outbreak of Legionnaires'
disease in a nursing home. Using our collection, we showed that
the urine antigen test used by the laboratory gave false
negative results. The specimens that allowed us to make this
discovery were destroyed.
4. Isolates from every hospital using our lab were stored in
our freezer. Having these isolates available in the future
would establish whether or not the hospital was the actual
source or the patient acquired the disease elsewhere. These
isolates were destroyed.
5. We demonstrated the development of resistance by Legionella
to a commonly-used water disinfection method--copper-silver
ionization. This observation was only made possible by
comparison of historical (frozen) isolates to present day
isolates. The specimens that allowed us to make this discovery
were destroyed.
6. We showed that the risk of illness to patients could be
predicted. Other scientists have requested our specimens for
study in their laboratories to study disease-causing traits and
evaluate new antibiotics. These isolates are no longer
available to the scientific community for study--they were
destroyed.
7. Our research was supported by the VA Merit Review System,
the U.S. Environmental Protection Agency, and industry. The VA
Merit Review study was an IRB approved study involving 20 VA
institutions across the U.S. The results of that VA Merit
Review-funded study were published in 2007 in the journal
``Infection Control and Hospital Epidemiology.''
8. We also showed that patients get Legionnaires' disease from
the drinking water in their own homes. This was an EPA-funded
IRB-approved study.
All of the isolates and specimens collected during the Merit Review and
EPA studies were destroyed.
Did We Collect These Isolates For Research Purposes and Was the
Research Approved?
Dr. Yu and the other VA infectious disease physicians participated
in approved research activities that involved the collection and
storage of microorganisms and specimens in the Special Pathogens
Laboratory (See Section 5). When the lab closed in July 2006, we had an
active R&D approved study that was in effect through December 2006
entitled ``Various Studies Examining Treatment, Prevalence and
Eradication of Legionella'' ID: 00137.
What Did We Do to Save the Collection?
Initially, I was not concerned about the transfer of the collection
from the VA. I knew that other VA investigators had left the VA and
taken their collections of specimens with them. The VA Research office
even told us that they had recently gone through this process with one
of the VA physicians.
July 2006--During a meeting in the Special Pathogens Laboratory in
July, Sue Mietzner, a microbiologist in our lab, showed Dr. Melham the
freezer where our collection was stored and told her of its importance.
She also showed her the location of the computer file describing the
isolates. The handwritten log book containing all the isolate
identification information was also left in the laboratory. I was never
asked to provide any information on the contents of our collection.
August 2006--I first expressed my concern for the safety of the
collection in an e-mail to Dr. Yu on August 12, 2006. In response, Dr.
Yu immediately sent an e-mail to Steven Graham, the head of Research
requesting his assistance in protecting the collection. In this e-mail
Dr. Yu stated ``I fear the vindictiveness of the administration . . .
may imperil this irreplaceable collection.''
We were reassured by Dr. Graham when he responded: ``Of course I
don't want to see valuable specimens destroyed, but these specimens are
biohazards so we must follow accepted procedures in order to transfer
them. We recently went through this process in regard to Dr. VonKammens
samples at Highland Drive.''
He told us that the collection ``must be moved to an institution
approved to handle biohazards. They must sign a materials transfer
agreement and have an approved biosafety program.''
In response, Dr. Yu and I obtained the assistance of Dr. Timothy
Mietzner, Professor of Molecular Genetics and Molecular Biology at the
University of Pittsburgh and on August 21st we requested the transfer
of these materials to his laboratory at the University of Pittsburgh.
More assurances came from Dr. Sonel, who replaced Dr. Graham as
head of Research in September of 2006. In an e-mail to me on October
5th, he stated ``We will work with you to facilitate the transfer.''
August and December 2006--There were numerous e-mails between me and
the Research office to affect the transfer of the collection, which
included sending the Material Transfer form to the Research office. I
actively engaged the Research office in my attempt to transfer the
collection to the University of Pittsburgh. VA Administration was
copied on these e-mails.
Throughout this time, there was never any indication that the
disposition of the collection was in question or that the collection
was in danger of being destroyed.
Dr. Sonel notified the Pittsburgh VA Administration on December 4th
that I was to meet the Research Compliance Officer on December 5th in
the Special Pathogens Laboratory to begin the process of transferring
the collection to the University.
In response to this information, and less than 24 hours before I
was to start the transfer of the collection they destroyed our
collection on December 4th, 2006.
The Pittsburgh VA administration failed to preserve and protect
this valuable scientific resource.
Were We Notified of this Action?
Dr. Sonel sent me an e-mail on December 4th informing me that he
``was asked by the front office to put this process on hold. I or
someone from the front office will be updating you soon regarding this
request. I apologize for any inconvenience that this may have caused.''
No one from the VA has ever contacted me regarding the destruction
of our collection.
For me as a scientist, and for Veterans and the American public--The
loss is incalculable.
A petition was published in the April 2008 issue of the medical
journal ``Clinical Infectious Diseases'' (CID 2008;46:1053-9) and
signed by over 250 scientists. They requested that an investigative
committee review the actions of the Pittsburgh VA Healthcare System
regarding the closure of the Special Pathogens Laboratory and the
destruction of a scientifically valuable collection of microorganisms.
The petition signatories and I thank you for your time and effort
today in fulfilling this request.
The Special Pathogens Laboratory
The Special Pathogens Laboratory has existed as a special
microbiology laboratory at the University Drive VA since 1981. The
initial funding and FTE's for the unit were provided by VA Central
Office in response to endemic hospital-acquired Legionnaires' disease
at the hospital. Thereafter, the Special Pathogens Laboratory has been
funded through the clinical microbiology laboratory ( a microbiology
sub account) as well as by grant and industry support.
The Special Pathogens Laboratory is a diagnostic, training, and
clinical research laboratory, varied in scope of operations and a
nationally recognized Legionella resource/reference center. The
microbiologists assigned to the Special Pathogens Laboratory are
responsible for day-to-day patient care testing, research projects and
laboratory functions. This includes the teaching and training of
students, clinical research and LegionelIa resource/reference
laboratory testing for VA and non-VA facilities.
Dr. Stout is an internationally recognized microbiologist who is an
expert on the microbiology and epidemiology of Legionnaires' disease.
Dr. Stout has assisted public health agencies such as the Centers for
Disease Control and Prevention as well as State and local health
agencies in Legionella outbreak investigations. The VA Medical
Inspector General contacted Dr. Stout in 2006 to assist in the
development of a Legionnaires' disease prevention plan for the VA
nationwide. She has over 70 peer-reviewed publications.
Closing of the Special Pathogens Laboratory
The Special Pathogens Laboratory has been active for approximately
25 years, and in that time has become internationally recognized as a
Legionella reference center. The closure of the laboratory was swift
and disorganized--the culmination of an inquiry that denied Dr. Victor
Yu (the Chief of Infectious Diseases and Microbiology) a fair appeal.
It was within this atmosphere of chaos that I was repeatedly
informed by Dr. Melhem that all Legionella testing functions of the lab
were to be transferred to the clinical microbiology laboratory. Only
one person in this lab has limited ability to perform Legionella
clinical testing and no one in this lab has the capability to perform
Legionella environmental testing.
This decision by Dr. Melhem and Mr. Moreland was made despite Dr.
Yu's repeated requests for a review of the decision by VA Central
office. In addition, one reason given by Dr. Melhem for the speed of
the closure was the imminent demolition of Building 2--the building
which houses the Special Pathogens Laboratory. When asked about this,
Engineering service could not verify this assertion.
I was required to meet with Dr. Gutkin and Cheryl Wanzie to
coordinate the move of equipment and Legionella testing supplies so
that this testing would be performed in Building 1 the clinical
microbiology laboratory. We agreed that this would be done on July
25th. July 19th, I was asked to meet with Dr. Melhem--Dr. Muder and
Cheryl Wanzie were present at this meeting. Dr. Melhem informed us that
the equipment and supplies would be moved within the next two hours!
Again she repeated the statement that Building 2 was set to be
demolished as a justification for the hurried pace. I was directed to
move all clinical specimens from our -70<SUP>+</SUP> freezer into a
freezer that was being moved (that day) to the clinical laboratory.
This required the removal and transfer of specimens from one freezer
into the other. It is important to note that as a Legionella reference
laboratory, we maintain a collection of specimens and isolates in these
freezers that are of historical significance and are irreplaceable.
Board of Investigation
Also within this same time period on July 19th, I was contacted by
David Cord to appear at a Fact Finding Administrative Board of
Investigation to testify as a witness. Mr. Cord noted that I was ``not
the subject of the investigation, but testifying as a witness.'' I was
to appear that afternoon.
It was at this time that I experienced cardiac-related symptoms and
called a friend to take me to my doctor's office. Upon arrival at the
office, the staff advised me to go to the emergency room (ER). I went
directly to the ER of West Penn Hospital. After undergoing several
tests, I was told that they wanted to admit me for additional tests,
including a cardiac stress test. After consultation with the ER
physician, I agreed to arrange for the testing the next day, and I
signed out Against Medical Advice (AMA).
Both Mr. Cord and Mr. Bonner were notified of my medical situation
and that my appearance at the board would need to be rescheduled. They
were also made aware of my scheduled leave for July 21 and July 24th.
Given that we were informed that access to the laboratory and our
materials would be restricted, I asked the laboratory staff to pack our
things. These files were removed to preserve our research. They were
then placed in the custody of my attorney.
The laboratory service secretary and time keeper (Lorraine
Paternoster) was notified on July 20th of my ER visit via voice mail
before 7 a.m. on July 20th. I requested four hours of sick leave for
July 19th (12:30-4:30 p.m.) and eight hours of sick leave for July
20th.
Thursday, July 20th, I went to my doctor's office to make
arrangements for the cardiac stress test. Given that I was scheduled
off to annual leave for Friday the 21st and Monday the 24th, I left
Pittsburgh to attend to my previously scheduled personal matter.
Cheryl Wanzie attempted to reach me on Thursday, but failed to do
so before I left Pittsburgh. She left a voice mail message at my home
stating that she was informing me that she had canceled my annual leave
and that I was considered absent without leave (AWOL).
Upon my return to work on July 25th, I called Mr. Cord expecting to
be interviewed at the ``Board of Investigation'' that day--given the
apparent urgency displayed the week before.
Instead I was told that my testimony was scheduled for Monday
August 2nd. I explained to Mr. Cord that I was scheduled off on annual
leave from Monday July 31st to Thursday August 3rd. I suggested that I
testify any time between July 25-28, but because Dr. Graham was out of
the office on vacation we had to wait until his return. I requested
that my testimony be scheduled for Friday August 4th or that we have
Dr. Graham attend the meeting via conference call. Mr. Cord arranged to
have my testimony scheduled for 10 a.m. on Friday August 4th.
I was notified on August 24, 2006 that the VA Pittsburgh Healthcare
System--University Drive Division proposed to remove me from my
position as a GS-11 Microbiologist with the Department of Veterans
Affairs for ``Misuse of Government Property: Failure to Safeguard
Confidential and Privacy Act protected Data in Violation of VA PHS
Privacy Policy, MCM RI-17.''
This action against me by the Agency was challenged with the
assistance and representation of the AFGE Union President Robert Bonner
and attorney George Love, Esq. The proposed termination was ultimately
not upheld by the Administration. Instead they imposed a 30-day
suspension--without pay. This action is also being challenged through
the merit System Protection Board (MSPB).
Upon completion of the 30-day suspension, I returned to the VA
Pittsburgh Healthcare System--University Drive microbiology section on
December 13, 2006. I was immediately presented with a ``Performance
Improvement Plan,'' (PIP) which claimed that my performance was
unsatisfactory in several critical areas. The items listed in the PIP
were complete fabrications. Interestingly, the PIP was signed by the
microbiology supervisor, but he emphasized that he had not participated
in writing it. He was, however, responsible for implementing it.
In addition, the new position description that was created for me
prior to my return to duty was never reviewed by the Union--per the
AFGE contract.
As mentioned previously, the Special Pathogens Laboratory was an
internationally-recognized Legionella reference laboratory. We
maintained a collection of specimens and isolates in the lab freezers
that are of historical significance and are irreplaceable. Despite our
inquiries for the transfer of this collection to the University, Dr.
Melhem ordered the destruction of this irreplaceable collection of
research material. This was done despite recommendations to the
contrary from Dr. Robert Muder--the Chief of Infectious Diseases. We
were never informed that this action was to be taken.
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Biography for Janet E. Stout
Dr. Stout received her BS in Biology from Clarion State College,
Clarion, Pennsylvania; and her Master's and Ph.D. degrees in
Microbiology from the University of Pittsburgh.
Dr. Stout is the Director of the Special Pathogens Laboratory in
Pittsburgh, PA and concurrently a Research Associate Professor in the
Department of Civil and Environmental Engineering University of
Pittsburgh.
Dr. Stout discovered the link between the presence of Legionella
bacteria in hospital water systems and the occurrence of hospital-
acquired Legionnaires' disease while working at the Pittsburgh VA
Medical Center. She was instrumental in the development of the
prevention strategy that serves as the foundation for the VHA
Legionella Directive. Dr. Stout gave the Professional Development
Course on Legionella at the American Industrial Hygiene Association
(AIHA) Conference in 2007.
She has authored approximately 80 peer review papers in the area of
Legionnaires' disease, which include papers in the New England Journal
of Medicine, Journal of the American Medical Association, the Journal
of Clinical Microbiology, and the Journal of the American Water Works
Association. Dr. Stout has also authored book chapters on Legionnaires'
disease, including the Legionella chapter in the Manual of Clinical
Microbiology.
Recent research projects include: Eradication of Legionella from
hospital water systems by copper-silver ionization and chlorine dioxide
and development of microbiological criteria for assessing risk of
Legionnaires' disease.
Dr. Stout is a member of the American Society for Microbiology, the
Association for Professionals in Infection Control, and the American
Society of Heating, Refrigeration and Air-conditioning Engineers
(ASHRAE).
Chairman Miller. Thank you, Dr. Stout.
Dr. Yu.
STATEMENT OF DR. VICTOR L. YU, PROFESSOR OF MEDICINE,
UNIVERSITY OF PITTSBURGH
Dr. Yu. Thank you so much, Mr. Chairman, Congressman
Rohrabacher and Congressman Broun for allowing us to tell you
this terrible tragedy.
As you mentioned, I am Professor of Medicine at the
University of Pittsburgh. I have been there since 1978, and
during most of those years I was also Chief of the Infectious
Disease Section at the Pittsburgh VA Medical Center. My CV is
51 pages long but I have published 600 papers and abstracts and
written six textbooks of medicine. I have gotten many honors in
my CV but I think I will only mention one. I received the
Distinguished Research Award from the American Legion for our
achievements and Janet's achievements in unraveling the mystery
of how the disease was contracted and how the disease might be
prevented and cured. That plaque honoring that achievement was
in the lobby of the Pittsburgh VA Medical Center for many
years, although I am told that it is no longer there.
The Special Pathogens Lab was established in 1980 and you
gave sort of a good overview, and Dr. Stout listed its
achievements, but it also made important discoveries in MRSA,
methicillin-resistant Staph aureus, antibiotic-resistant
bacteria, pneumonia, and urinary tract infections. We
ultimately established collections of fungi and virtually all
human pathogens of man that are commonplace. We established
international collaborative studies with investigators in
Africa, Australia, New Zealand, China, Hong Kong, Argentina,
Brazil, Canada, Norway, Sweden, every inhabitable continent.
Investigators interested in antibiotic-resistant bacteria
contributed pathogens to our laboratory and in huge
international collaborative attempts actually collected data
from these patients and then sent the isolates to one standard
reference laboratory. Over 200 publications from these talented
and prestigious investigative groups from France to Taiwan to
Australia participated in this massive effort, which was a true
international community effort.
When we first started in the early 1980s, we had one
microbiologist and one graduate student named Janet E. Stout,
and then over time the VA asked us to come under a mandate
called the Special Clinical Resource Center. We became the
Special Pathogens Lab of the entire Pittsburgh VA Center, and
over the next 10 to 12 years we have evolved into five
laboratory scientists headed by Dr. Stout. And then in 2006,
inexplicably, Mr. Moreland, the director of the VA, terminated
the laboratory. On Wednesday he came in, handed us a directive,
the laboratory is closed. There was no forewarning of any sort.
All five individuals, university employees who are scientists,
were all terminated immediately. They lost their livelihood. No
explanation was given. On July 12, one week later, I asked for
a written explanation of why this happened. The effect was so
stunning that we couldn't understand why it was done and I said
it is morally imperative for you to place in writing why you
terminated this laboratory of 20-plus years with all of its
accomplishments and give us the reasons why so that we could
respond. We couldn't even appeal because 48 hours later, all
the personnel had to evacuate. They were told that if they left
their personal belongings behind, they would never be able to
retrieve them. And 48 hours later, the laboratory was
padlocked. However, Mr. Moreland forgot one thing. We were
processing specimens for patients in the ICU in addition to
patients from medical centers all over the country. So if he
terminated immediately, what about the patients at the VA
Highland Drive, a few miles away? What about patients in the
ICU a few floors away? So they reluctantly gave us 14 days but
they gave me an order: no more specimens from anyplace else can
be processed and tell everybody that you cannot have any more
specimens processed. But we had 600 clients and they don't send
us specimens every day. As outbreaks occur across the United
States, public health departments who wonder if it is
Legionnaires' disease send their specimens by Federal Express,
and you can see the UPS and Federal Express trucks coming every
day dropping off specimens, and now we have 10 to 14 days to
process all these specimens. We couldn't contact 600 clients by
fax. So now I had to make a decision. Should I not process
these specimens, and since they gave us no reason for the
closure, I sent an e-mail to Mr. Moreland and I said I have a
difficult decision to make, Mr. Moreland you have told me I
cannot process any of these specimens, and specimens from
Bayside Hospital, Johns Hopkins-affiliated hospitals, Phoenix
VA were coming in and they were thinking that maybe they had
outbreaks of Legionnaires' disease. So I as a physician
researcher placed an e-mail and said I have a conscience as a
physician researcher. I can decide to disobey the order and
know that I will be terminated as my laboratory colleagues were
terminated or I can do my duty.
I did my duty. We processed those specimens. But we needed
supplies and the supplies were kept by the security police from
entering into the laboratory. Microscopes were taken from our
laboratory, and there is documentation of all the disruptions.
They held a hearing, and the laboratory technicians had to
leave their job and go to a witch hunt-type hearing, and they
were told that if you don't come, maybe there is going to be
problems, so they went to these hearings and then we had to
process all these specimens that were coming in including
patients in our own intensive care unit. So there was
tremendous pressure on all of us. Janet Stout even ended up
having to go to cardiac clinic because she was developing chest
pains. But we worked hard on it. They rose to the occasion.
When we ran out of supplies, the laboratory researchers pooled
their own funds to buy supplies and bring them into the lab. If
they had to go to the bathroom and they walked outside the
door, the laboratory door fell shut. The security guard refused
to let them in. They had to use their cell phones to call the
lab people inside to let them in.
The work continued. And we had 15 specimens left from a
government building, 14 hospitals and from a wife of a patient
who died of Legionnaires' disease who was trying to find out if
the source of her husband's Legionella came from their water
supply, and in the appendix is the discussion of what she went
through. She was in California and couldn't find a laboratory
to do the processing, and then through a contact at one of the
hospitals she ended up calling Janet Stout, who advised her
what to do. She estimated that the cost from the other
laboratories that she contacted would be over $2,000. Janet
Stout said that she would do it for free, send us the specimens
as soon as possible, but the timing was so bad. By the time she
got to the specimens and Federal Expressed them to us, we
planted the cultures. She wanted to know what the results were;
so did we. Mr. Moreland said you cannot look at the culture
results. We had processed all the specimens. All Janet had to
do was look at the culture plate, and using dyes that were
formulated by this Pittsburgh VA, we could tell if there was
Legionella, and then using a microscope we could identify if it
was Legionella. Fifteen specimens lined up on the counter. We
asked for permission to go back into the hospital on day 11
after day 10 to give the results to these hospitals and to the
wife. It was refused.
Over the next two weeks the specimens dried up. We don't
know what the results were and we thought we lost it for the
hospitals, but the Phoenix VA got lucky. Why? Because their
specimens were the last specimens processed. They were
interpreted and read and faxed. Sixty-five percent of the
Phoenix VA water samples were positive for Legionella. They
sent the specimens to us because they suspected an outbreak of
Legionnaires' disease but there was controversy within the
center that were these really Legionella. Well, maybe--we have
a VA reference lab. If it is, we will look in the water. They
found it. That was the last duty of the Pittsburgh VA Special
Pathogens Laboratory.
Chairman Miller. Dr. Yu, this is compelling testimony but
could you summarize?
Dr. Yu. Yes.
Chairman Miller. Thank you.
Dr. Yu. Okay. So the one question is, and I had to listen
to it for all these years, the last two years, this is not
approved research. It is not approved research, all these
papers? And then two weeks ago I got from your committee a
document that I had never seen before and it says VA Pittsburgh
Healthcare System Publication Audit. This was the document that
Mr. Moreland used to say that we did unapproved research. All
these Merit Review publications, that wasn't approved? So I
looked at it, and this is one of the cleverest documents that
man has ever contrived. A full description is in the Appendix,
but I will give you the highlights. Six articles that had no
documentation and this document is the documentation in
Appendix B. Ten out of these 39 studies, all 39 studies, there
is no documentation. Ten were observational studies, and under
federal code do not have to be mandated by human rights review
so they included these 10 studies that we had published. Seven
studies that were not--that were published and not approved by
the VA were studies from other hospitals. One of them was in
Russia, and if a study is done in Russia, it doesn't need
Pittsburgh VA IRB approval. Three studies had no patients in
them, and if you do a study with no patients, you don't have to
have human IRB approval. Every one of the 39 articles was
legitimate.
So why are these microbes so important? Well, here is one
example. One study came from published in Chest. It said there
was no documentation, and in the Appendix, the documentation is
there. Two other studies by Janet Stout said no documentation,
and they were there. And what were those studies? We received a
compound from Daiichi, Japan. We were looking for antibiotics
that would cure Legionnaires' disease because the mortality was
still high using existing antibiotics. Dr. Stout devised an
intracellular model that you wouldn't have to use animals, so
using that model, she found that this compound was highly
active, more active than any compound we had ever seen. Then we
recommended that it go into clinical trials. OrthoMcNeil
developed a compound for clinical trials and it was given to
several thousand patients in the United States with community
pneumonia and hospitals all over the United States started
sending their culture specimens to Janet Stout to see if they
had Legionnaires' disease, and we found all these cases of
Legionnaires' disease that no one would have suspected if they
had not been sent to Dr. Stout.
And then we broke the code. What antibiotic did these
patients receive? They received levofloxacin, the new name that
OrthoMcNeil gave this compound. The mortality for Legionnaires'
disease in this study was zero percent. Well no antibiotic is
100 percent effective. Four years later, in the largest
outbreak ever to hit Europe, over 200 patients contracted
Legionnaires' disease. The decision was made to give every
single patient levofloxacin. Not a single patient died. Think
about all the patients who died in the American Legion outbreak
in 1976. Organisms that we had, Mr. Moreland destroyed all of
these organisms. We now receive compounds from all over the
world and we can't do the studies anymore and we can't devise a
diagnostic test because of what Mr. Moreland did.
Thank you.
[The prepared statement of Dr. Yu follows:]
Prepared Statement of Victor L. Yu
Introduction
Academic credentials
Legionnaires' disease (LD)
Pneumonia
Bloodborne pathogens
MRSA
Antibiotic resistance
Encounter with Legionnaires' disease
Pittsburgh VA outbreak of hospital-acquired cases
High mortality
Unknown source
Outbreaks in VAs
Breakthrough discoveries
Culture media development and other tests
LD commonplace, but undiagnosed unless special tests done
Source discovered--drinking water of hospital
Establishment of Special Pathogens Lab (SPL)
Veterans Research Foundation (VRF) of Pittsburgh
Antibiotic studies
Diagnostic lab studies
Water disinfection studies
Development of experience and expertise
Lab space with intention of bringing in research funds to
support VRF
Hiring of University employees
Special Clinical Resource Center with ability to bring in
funding
Development of expertise--Five FTEs
University funds and equipment
Research M.D. fellows and graduate students
Advances in treatment and prevention of Legionella
Disinfection of hospital drinking water
Antibiotic cure
Expansion into other infectious diseases
Bloodborne pathogens--Klebsiella
Antibiotic-resistance microbes--MRSA
Pneumonia, Endocarditis, Urinary Tract Infections
SPL as mecca for infectious disease research
Visiting researchers
Grants
Large-scale collaborative studies
Breakthroughs in antibiotic resistance, bloodborne pathogens
Abrupt closure of SPL with two-days notice
No apparent reason for this drastic action
Refusal to process incoming specimens including Phoenix VA
Confiscation of university funds and equipment
Destruction of scientific collection
No warning
No explanation
VA response to Congressmen, lay media--
No research performed
Unlabeled specimens
Unapproved studies
Response to VA audit of unapproved studies
Discussion of specific studies showing value of collection
Levofloxacin
Klebsiella
MRSA
Introduction
My name is Dr. Victor Yu. I am a Professor of Medicine in the
Division of Infectious Diseases at the University of Pittsburgh. I have
been a University Professor since 1978 and most of that time was also
Chief of the Infectious Disease section at the VA Medical Center, an
affiliated teaching hospital of the University of Pittsburgh.
I have published widely on Legionnaires' disease, pneumonia,
bloodborne pathogens, MRSA (Methicillin resistant Staph. aureus),
antibiotic resistance, anal medical informatics. I have a background in
mathematics and computer science so I have devised an idea of
accumulating clinical information about patients, their laboratory
values, their underlying diseases, the antibiotics that they received,
and their outcome. I realized that having a computer database for
thousands of patients would enable us to make statistical correlations
about epidemiology and therapy In the era of antibiotic resistance and
new emerging pathogens, such a database has been invaluable.
Using this approach, over .100 articles in different areas of
infectious diseases have been published and led to therapeutic
advances. I organized large international collaborative groups of
physicians and scientists who have contributed patient information into
the computer database as well as microbial pathogens that caused these
infections. This treasure trove of computerized data plus a collection
of human pathogens has led to many advances in management and diagnosis
of very difficult infectious diseases.
Encounter with Legionnaires' Disease
After the American Legion outbreak in Philadelphia in 1976, it was
soon discovered that other cases of Legionnaires' disease were
occurring. As a junior assistant professor in 1979, I came across the
first cases of hospital-acquired or nosocomial Legionnaires' disease.
It had caused a serious problem at three VA Medical Centers: Wadsworth
VA Medical Center in Los Angeles, the Pittsburgh VA Medical Center, and
the Togus, Maine VA Medical Center: It was a shock to find out that it
was being contracted by patients in the hospital.
Dr. Janet E. Stout, Ph.D., would soon make the startling discovery
that the Legionella bacteria; the causative agent of Legionnaires'
disease was in the driving water supply of the hospital. The prevailing
theory at that time was that it was in cooling towers and air
conditioners. Even today, many physicians are not aware that drinking
water is the major source.
Because of this occurrence, we were given funding by VA Central
Office to add a special microbiologist to the Infectious Disease staff
to assist us. Legionella is a fastidious organism that requires
expertise and special techniques to isolate. Dr. Susan Mather in VA
Central Office (enclosed letter) oversaw the investigation into
Legionnaires' disease.
One of the reasons we were given extra funding and assistance is
that outbreaks were being described all over the world besides the VA
Hospital, and we had formulated a culture media that microbiologists
could identify Legionella by the coloration on the culture plates. This
technical advance accelerated the ability to diagnose Legionella from
patients and from the environment. Over the next many years, we would
accomplish a number of things with respect to Legionella, microbiology
and public health.
Dr. Stout has listed the advances made by the VA Special Pathogens
Lab in her testimony which includes evaluating all the commercially
available tests for Legionnaires' disease, evaluating all commercially
available antibiotics for therapy of Legionnaires' disease, describing
the clinical manifestations of Legionnaires' disease, and formulating
the disinfection method of eradicating Legionella from drinking water.
HISTORY OF THE SPECIAL PATHOGENS LABORATORY
The Special Pathogens Lab was established in about 1980. Because of
the large number of outbreaks that were occurring in Veterans Affairs
Medical Centers, VA Central Office awarded two full-time employee slots
to Pittsburgh to respond. During those early years, we pioneered the
use of various tests and most importantly, formulated the culture media
in which Legionella could be identified by color, thus allowing the
microbiologists to get preliminary identification of the Legionella by
looking at a culture plate; a microscope was not needed. In the next
several years, we became quite prolific in advances in Legionnaires'
disease.
About 1984, we received our first VA Merit Review Grant dealing
with Legionnaires' disease. About three years later, Martin Sax, then
Chief of the Research and Development Committee, approached us and
suggested that we become active members of the Veterans Research
Foundation. Given our reputation, we could solicit funds from industry
and other sources to supplement the funds coming into the Veterans
Research Foundation. He offered us lab space as cuts in the VA budget
were forcing many VA researchers to discontinue their studies. We
agreed. We subsequently were able to bring in funds from foundations
and industry for work on disinfection modalities, and antibiotic
studies of a whole host of pathogens, including Staphylococcus aureus
(MRSA), Streptococcus pneumoniae, Enterococcus, Pseudomonas aeruginosa,
Enterobacter, Stenotrophomonas maltophilia, Bacteroides, and fungi
(Candida, Cryptococcus, Aspergillus).
However, in subsequent years we branched out into pathogens of
community-acquired pneumonia, urinary tract infections, abdominal
abscesses, and endocarditis. We acquired expertise in antimicrobial
resistance and published about 100 articles in this area. We were able
to bring in hundreds of thousands of dollars into the Veterans Research
Foundation which allowed them to gain critical mass and justify
laboratory space.
In 1994, as the VA budget was being cut, VA Central Office sent out
a solicitation to academic researchers about the possibility of using
their capabilities to initiate laboratories for profit. This was based
on a 1994 Special Clinical Resource Center memorandum. In 1996, the
Director of the VA and Chief of Pathology agreed that designating the
Special Pathogens Laboratory as Special Clinical Resource Center was
feasible. And, in 1996, the Special Pathogens Lab went national.
Over the next many years our laboratory and clinical work
continued. Funds were brought into the Veterans Research Foundation
under grants I wrote as Professor of Medicine at the University of
Pittsburgh. Five University employees including a CDC-trained
microbiologist were brought in to handle the growing amount of research
activity. New instrumentation, equipment and supplies awarded to the
University of Pittsburgh was brought into the Special Pathogens Lab.
All this equipment was tagged as University of Pittsburgh equipment.
In those early years, the VA budget was very thin and most VA
laboratories were not only understaffed but their equipment was
outdated. Since we were using microbiology equipment for research which
also could be used to handle the clinical load, we outfitted the VA
Clinical Microbiology Laboratory with modern equipment and furniture.
This made our laboratory one of the best equipped laboratories in
Pennsylvania, and both the research and patient care benefited.
Graduate students, infectious disease fellows, and visiting
professors, came to the Special Pathogens Lab to our laboratory to
learn new techniques and assist with clinical studies. Their
participation led to many breakthroughs in infectious diseases over the
next 12 years.
In 2006, inexplicably, the Special Pathogens Lab was shut down by
Mr. Moreland, Director of the Pittsburgh VA. The specific reasons were
never given to us as noted in my letter of July 12, 2006 (Appendix). We
were given only 48 hours notice and the entire tab was to be shut down.
All the Lab personnel were fixed, and the Lab was to be padlocked. Mr.
Moreland had been in his position as Director of the Hospital for only
a few years and some of the laboratory personnel had been there for
more than 10 years and their livelihood and occupation was shattered
with one 48-hour notice. It should be noted that this violated the
provisions of the Special Clinical Resource Center memorandum which had
guidelines to insure that patient care and other aspects would not
suffer from abrupt lab closure.
However, Mr. Moreland overlooked the fact that we were processing
specimens for the Pittsburgh VA Medical Center patients as well and
reluctantly agreed to a two-week moratorium. During that time specimens
from all over the country continued to come into the Special Pathogens
Laboratory as usual.
We were ordered to notify all of our clients that the lab was being
closed, but since we had 600 different clients including health
departments and hospitals, faxing to 600 clients was impossible.
Moreover we had two weeks to complete a huge workload. During this
time, the laboratory personnel were harassed by security guards and
administrators. Microscopes were removed. When the laboratory
technician left the laboratory for breaks or lunch, the security guards
refused to unlock the doors such that the personnel in the lab had to
come out an open the doors for them. It was a Gestapo-like atmosphere
and caused tremendous stress among the laboratory personnel. Yet, they
accelerated their efforts in trying to process all the samples that
were coming in.
Because the results were so important to the hospitals and health
departments, we no longer had the time necessary to enter them into the
computer, send out invoices, and so forth. Moreover, Mr. Moreland
stopped the supplies from entering into our laboratory so that supplies
which had been purchased were not allowed to be used and delivered to
the personnel. Moreover, he refused to allow us to purchase materials
for the specimens which included Pittsburgh VA patients to lie
processed. The laboratory personnel pooled their own funds to buy these
supplies.
They were true heroes working for the VA patients and the U.S.
community. In the last two weeks, Mr. Moreland ordered me to stop
accepting specimens from outside the University of Pittsburgh. I wrote
to him that this was a Hobson's choice: Obey an administrative order
from the Director or follow my conscience as a physician researcher and
process specimens from patients, hospitals, and public health agencies.
I decided to process these specimens and informed Mr. Moreland the
reasons for doing so. One set of samples came from the Phoenix VA
Medical Center. Sixty-five percent of the hospital drinking water
specimens yielded Legionella and uncovered an endemic outbreak of
Legionnaires' disease. This outbreak and the source would not have been
identified if I had not continued to process the incoming water
specimens.
During this time, the Lab personnel were not only harassed, but
each was asked to give sworn testimony at an investigative hearing.
This was done during their work hours and added to their stress.
The saga of what happened to the last 15 clients' specimens that
were processed is a matter of record (See www.legionella.org/
vaspl.asp). On the day of closure where the lab was to be padlocked,
culture specimens from 15 clients remained to be read. They included
hospitals, a government building, and samples from a patient's home.
The lab successfully processed all these samples, but since they
required 48 to 72 hours of incubation, they could not be read. The
security guards would not allow staff into the laboratory. We made a
plea to Mr. Moreland to allow the culture plates to be read. He
refused. We made a plea to VA Central Office; they never replied.
However, Senator Arlen Specter wrote a letter to Mr. Moreland on our
behalf requesting that the final 15 culture samples be processed. He
ignored that request. We offered to transport the VA cultures to
another laboratory. Mr. Moreland refused. Those culture specimens dried
out in the laboratory, were left unread, and ultimately trashed. The
only thing that was needed to be done was to interpret the culture
plates.
Ironically, in the 10 days after the closure, the Pittsburgh
Tribune Review ran a front-page story of accomplishments of the
Pittsburgh VA with the discovery of Legionnaires' disease. Because of
the National Legion Convention was held in Pittsburgh that week,
Congressmen from Pennsylvania attended. The American Legion knowing of
our contacted Congressman Mike Doyle and Senator Arlen Specter; both of
whom wrote letters of support. These letters were ignored by Mr.
Moreland and VA Central Office.
The reasons they gave to the Congressmen and to the lay media are a
matter of record. For example, Mr. Cowgill alleged we were not
processing VA specimens but instead processing specimens from other
countries. In letters from VA Central Office, William Feeley, Under
Secretary, claimed we were not doing any research and that commercial
labs could do the same work. These were outrageous exaggerations and
untruths.
We have already furnished documentation showing errors and the
difficulty of doing Legionella laboratory work. Experience, training
and special equipment is necessary. We had become the premier reference
laboratory for Legionella for the United States. Not only were visiting
professors and scientists coming to the lab, but commercial
laboratories sent their technicians to our laboratory to learn the
correct technique as mandated by the American Society of Microbiology
Manual of Clinical Microbiology written by Janet Stout and John D.
Rihs. We did not charge for this teaching.
Response to VA Audit
In response to the outcry generated by the destruction of the
scientific collection, the VA claimed that I had conducted non-approved
research studies. The conducted an audit which was never shown or
discussed with me. I obtained a copy of this audit from congressional
investigators. In this biased audit of 39 articles and 11 projects, not
a single study was found to be non-approved. The audit by the
Pittsburgh VA administrators showed numerous errors that were obvious
and blatant. Some examples:
Seven articles were cited as having no documentation for VA
approval involved no VA patients and were not performed at the VA (one
of these studies involved no patients whatsoever and would not be
covered by human subject review).
Six articles were cited as having no documentation. Yet Appendix B
contained the documentation for all of these articles.
Ten articles were cited as having no documentation were
observational studies that did not fall under human subject research as
defined by federal code. So no approvals were required.
Two articles were cited as having no documentation. However, the
articles did not involve any patient contact or physician intervention,
and therefore would not require human rights approval.
Three articles involved clinical trials and intervention which
would require IRB and R&D approval. The audit showed that all three
were approved.
Articles by Dr. Yu that were funded via VA Merit Review and would,
of course, be approved by the VA R&D committee were not included in the
audit.
In Appendix B, 11 Projects were reviewed. All 11 Projects were
approved by R&D and/or IRB. Missing forms were cited, although it was
clear that the studies were approved by R&D and IRB. Since approval was
given, these forms were either lost by the R&D Committee or overlooked
by the auditor.
For full details, see Appendix. Response to VA Publication Audit by
Victor L. Yu.
The sheer number and the blatancy of these errors are consistent
with a witch hunt conducted by a biased VA administration.
Klebsiella and Levofloxacin studies were cited inaccurately as
unapproved. Details of the studies are summarized below.
Klebsiella--a virulent Klebsiella discovered by us in an
international antibiotic resistance study was found in Taiwan but not
elsewhere. In the past five years, patients who are Asian have been
found to have a similar disease in the U.S. Two critically-ill patients
were referred to us who were non-Asians and had not traveled outside of
the U.S. Examination of the molecular type of these Klebsiella showed
that were identical to the Taiwan Klebsiella. This Klebsiella is now in
the U.S. Our entire collection of Klebsiella collected in two large-
scale studies in the U.S. and all six inhabitable continents was
destroyed. We lost the ability to compare the molecular characteristics
of the Klebsiella in our collection with those of newly-infected
patients. Study of our original collection and new Klebsiella would
allow us to develop antibiotics and vaccines. (See Appendix--Approval
from Request to Review Research Proposal for ``Pathogenicity of
Klebsiella'')
Levofloxacin: Janet Stout found a new compound from OrthoMcNeil to
be highly effective in the lab against Legionella. This compound was
brought to clinical use and in the first trial of pneumonia, the
compound cured an amazing 100 percent of patients with LD. This
experience was reported and the compound was released as levofloxacin.
Four years later, levofloxacin was used in a huge outbreak of LD in
Spain. One hundred percent cure. All of our Legionella isolates were
destroyed. (See Appendix--Response to publication audit. Project 9.
Documentation of approval of ``Levaquin Community-Acquired Pneumonia'')
In summary, this massive collection of more than 8,000 microbes
(5,000 Legionella, 300 species of other bacteria and fungi), 3,000
patient sera, and 202 patient specimens (urine, respiratory tract) was
destroyed without warning. The VA administration never even confirmed
that this collection had been destroyed despite repeated requests. The
collection was unique in that the microbes and specimens were linked to
the clinical histories of the patients who were infected by, these
microbes.
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Biography for Victor L. Yu
Victor L. Yu, M.D., is a Professor of Medicine at the University of
Pittsburgh, Pittsburgh, Pennsylvania. He majored in mathematics at
Carleton College, earned his medical degree at the University of
Minnesota, and performed his internship and residency at the University
of Colorado and Stanford University. He performed his postdoctoral
fellow in infectious diseases at Stanford University. His research
interests include Legionella infections, antimicrobial resistance, and
medical informatics. He had published over 300 scientific papers,
contributed to chapters to over 70 books, and is Editor-in-Chief of
three textbooks. He is also the editor of www.antimicrobe.org, a state-
of-the-art website for antimicrobial agents and infectious diseases. A
major accomplishment has been the 50 students and fellows he has
mentored who are now active in research and academic positions
throughout the world. Dr. Yu has accepted over 200 invited lectures and
visiting professorships internationally. He has received numerous
awards including these from the American Legion, Health Research and
Services Foundation, American Society for Microbiology, National
Institutes of Health, the Federal Research Executive Board, and
Australasia Infectious Disease Society. He was elected to Best Doctors
in America from 1996-present (Woodward, White, Inc.), and Top Doctor
2006-present (Castle-Connelly). He is the recipient of the Emmanuel
Wolinsky Award given by the Infectious Disease Society of America for
the Best Original Article published in Clinical Infectious Diseases for
2003.
Chairman Miller. Thank you, Dr. Yu.
Dr. Snydman.
STATEMENT OF DR. DAVID R. SNYDMAN, CHIEF, DIVISION OF
GEOGRAPHIC MEDICINE AND INFECTIOUS DISEASES, AND ATTENDING
PHYSICIAN IN INFECTIOUS DISEASES, DEPARTMENT OF MEDICINE, TUFTS
MEDICAL CENTER; PROFESSOR OF MEDICINE AND MICROBIOLOGY, TUFTS
UNIVERSITY SCHOOL OF MEDICINE
Dr. Snydman. Thank you, Mr. Chairman and Members of the
Committee. Thank you for inviting me. I am Dr. David Snydman. I
am Chief of the Division of Geographic Medicine and Infectious
Diseases at Tufts Medical Center in Boston and professor of
medicine and microbiology at Tufts University School of
Medicine. I offer my CV, which outlines my training and
expertise in the fields of microbiologic research as well as
clinical research within the field of infectious disease.
Due to time constraints, I will not go into details about
my training or publication record, which are listed on my CV,
but I will state for the record that I conduct studies in
infectious diseases using the microbiology laboratory and I am
nationally and internationally recognized for my research. I
have been funded by the NIH for many years for many of the
studies that I have published. I have collaborated with Victor
Yu in a variety of studies conducted over the past 20 years or
more. Many of these have been published in the highest-level
journals within the field of clinical infectious diseases and
microbiology.
Let me also state that I have publicly praised the VA
health care system in an editorial I wrote for the Mayo Clinic
proceedings regarding quality of care around central line-
associated infections, so I come to this proceeding as someone
who recognizes the value of the VA health care system. I have
never been an employee of the VA but have worked as a medical
resident at the Boston VA and volunteered in the Atlanta VA
while I was employed by the Centers for Disease Control. I am
trying to offer as dispassionate and objective an opinion as
possible.
I have been asked by the staff to comment on a number of
issues pursuant to these proceedings including the value of the
resource of the Special Pathogens Laboratory in the Pittsburgh
VA Hospital as well as the studies which were foreclosed by the
destruction of the isolates and the value of the research
conducted by Drs. Yu and Stout. I have also been asked as to
how I learned of the destruction of the isolates housed in the
Special Pathogens Laboratory, to comment on my actions and to
comment on changes in policies Congress should consider in
order to prohibit such actions from happening in the future.
First, let me say from the outset that the question should be
broadened to include isolates other than Legionella since many
of the isolates the Special Pathogens Laboratory housed were
microbiologic species of bacteria and fungi other than
Legionella.
I first learned there was a problem in the Special
Pathogens Laboratory in July of 2006. I actually called Dr. Yu
in late June or early July of that year to discuss a case of a
very rare disease, Legionella endocarditis. I wanted him to try
to isolate the organism from a heart valve that needed to be
replaced in a patient I was consulting on. Our laboratory had
not been able to isolate the organism but there was a strong
suspicion that Legionella was causing the disease based on a
number of clinical factors. Since treatment requires six months
or more of therapy, I wanted to get as definitive an answer as
possible. I knew that Dr. Yu had the expertise to perform
specialized studies on the valve including the use of molecular
diagnostic tools. He told me that he would try to perform the
studies, to hold onto the blood cultures and he would give me
instructions as to how to send them. After some time he told me
he would not be able to perform the studies and indicated the
laboratory would be shut down. I was quite disturbed and asked
if there was anything I could do. I subsequently wrote to the
VA hospital administration in Pittsburgh protesting this action
as well as Senator Specter and some in the Pennsylvania
Congressional Delegation. I later found out, much to my dismay,
that the isolates from the whole collection were destroyed. I
eventually wrote the viewpoints piece for the journal Clinical
Infectious Disease, which is the official clinical journal of
the Infectious Disease Society of America. I have appended this
article for submission with my testimony.
With respect to the research done by Drs. Yu and Stout, one
can only conclude that it is of the highest caliber in the
world. They are internationally recognized for their work and
expertise in Legionella as well as other pathogens and their
laboratory set the standard for our understanding of the
environmental control for Legionella. If I may read into the
record part of the viewpoints piece, I believe the Committee
will get a flavor for the value of the collection. ``Dr. Yu
established a series of national and international
collaborations to elucidate our understanding of the
microbiological and clinical management issues of bacteremia
due to many different organisms. These studies were seminal in
many respects. They changed our understanding of the
relationship between appropriate and inappropriate therapy, the
relationship between the minimum inhibitory concentrations of
isolates to antimicrobial agents in outcome, and the molecular
epidemiology of relapse and re-infection as well as relatedness
of strains throughout the world. The studies are far too
numerous to articulate in detail or even list here in total but
they include studies of the major pathogens that confound us
today including Staphylococcus aureus, Pseudomonas aeruginosa,
extended spectrum beta-lactamase producing Klebsiella
pneumoniae, Enterobacter species, Stenotrophomona maltophilia,
Enterococcus species, Bacteroides fragilis, Streptococcus
pneumoniae, and Candida species. The concept was simple:
observe the clinical presentation of bacteremia or fungemia and
follow outcomes while correlating microbiology to outcome. The
studies were prospective, and all the isolates were collected
and sent to a central laboratory, the Pittsburgh VA Special
Pathogens Laboratory, for more definitive analysis. Each of the
studies emanating from this collection has changed our
knowledge base and contributed significantly towards optimal
management of patients with these infections. Capturing the
isolates and making sure they were sent was an important and
difficult task, especially for fastidious organisms like Strep
pneumoniae and Bacteroides species. Given the international
component as well as the requirements for sending specimens
across national borders, these studies were difficult to
perform. All studies were approved as per local IRB
requirements and permits were obtained from regulatory
authorities. Nevertheless, the number of studies and important
insights total well over 100 peer-reviewed articles and have
provided important information that correlate outcome with the
use of certain antibiotic classes as well as levels of
susceptibility. Some of the studies have challenged prevailing
dogma and helped provide data for the CLSI, the Clinical Lab
Standards Institute.''
I go on to point out, ``These isolates were accrued purely
for the advancement of science and beneficiaries of these
studies were the patients infected by these microbes. Moreover,
these isolates and samples would have proven invaluable in the
future in that these strains would enable comparison over time
for changes in pathogen virulence, antimicrobial susceptibility
correlation with outcome, and changing genetic diversity as
well as the development of new molecular tests.''
The value of the collection is that it was linked to
clinical outcomes. This kind of collection does not really
exist anywhere in the world, and these studies are really quite
difficult to organize and complete. The reason this is so
important is that one can correlate microbiologic factors to
clinical outcomes, and with a large number of patients and
specimens to study, one can control for confounding variables
such as underlying host factors which might relate to the
clinical outcome. The Committee should note that one of our
studies on pneumococcal bacteremia was given a national award
at the annual meeting of the Infectious Disease Society, the
Emmanuel Linskey Award, as the best clinical paper for the
year.
The studies which were foreclosed by the destruction of
these isolates included any study of new pathogenic factors
that might be related to microbial pathogenesis in a variety of
organisms changing microbial diversity, which we recognize as
continually evolving, and factors that might relate to
antimicrobial resistance and susceptibility. While these
organisms exist in nature and can be grown from the environment
as well as people, the fact that there was a collection of
organisms linked to outcomes made the collection invaluable to
science. It would have been relatively simple to maintain the
collection since many organisms are maintained in freezers in a
holding solution. Some agreement should have been entered into
between the parties that wanted to close the lab and Drs. Yu
and Stout in order to give them time to make arrangements for
transport of the specimens to another laboratory. To just
destroy the specimens as was done was a wanton, thoughtless
act. It is for this reason that I wrote my viewpoints piece for
publication and appended a petition which has been signed by a
number of clinical and microbiologic research scientists
throughout the world, and I am happy to attend these
proceedings. Thank you.
[The prepared statement of Dr. Snydman follows:]
Prepared Statement of David R. Snydman
I am Dr. David R. Snydman, MD, Chief of the Division of Geographic
Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA and
Professor of Medicine and Microbiology, Tufts University School of
Medicine. I offer my C.V., which outlines my training and expertise in
the fields of microbiologic research, as well as clinical research
within the field of infectious diseases. Due to time constraints I will
not go into details about my training or publication record which are
listed on my C.V., but I will say for the record that I conduct studies
in infectious diseases using the microbiology laboratory and am
nationally and internationally recognized for my research. I have been
funded by the NIH for many years for many of the studies I have
published. I have collaborated with Dr. Victor Yu in a variety of
studies conducted over the past 20 years or more. Many of these have
been published in the highest level journals within the field of
clinical infectious disease and microbiology. Let me also state that I
have publicly praised the VA health care system in an editorial I wrote
for the Mayo Clinic Proceedings regarding quality of care around
central line associated infections. So I come to this proceeding, as
someone who recognizes the value of the VA health care system. I have
never been an employee of the VA but have worked as a medical resident
in the Boston VA and volunteered in the Atlanta VA while I was employed
by the Centers for Disease Control. I am trying to offer as
dispassionate and objective opinion as possible.
I have been asked by the staff to comment on a number of issues
pursuant to these proceedings, including the value of the resource of
the Special Pathogens laboratory at the Pittsburgh VA hospital as well
as the studies which were foreclosed by the destruction of the
isolates, and the value of the research conducted by Dr. Yu and Dr.
Stout. I have also been asked as to how I learned of the destruction of
the isolates housed in the Special Pathogens laboratory, to comment on
my actions, and to comment on changes and policies Congress should
consider in order prohibiting such actions from happening in the
future.
First, let me say from the outset that the question should be
broadened to include isolates other than Legionella, since many of the
isolates housed in the Special Pathogens laboratory were microbiologic
species of bacteria and fungi other than Legionella.
I first learned that there was a problem in the Special Pathogens
laboratory in July 2006. I actually called Dr. Yu in late June or early
July of that year to discuss a case of a very rare disease, Legionella
endocarditis. I wanted him to try to isolate the organism from a heart
valve that needed to be replaced in a patient I was consulting on. Our
laboratory had not been able to isolate the organism but there was a
strong suspicion that Legionella was causing the disease based on
several factors. Since treatment requires six months or more of
therapy, I wanted to get as definitive an answer as possible. I knew
that Dr. Yu had the expertise to perform specialized studies on the
valve, including the use of molecular diagnostic tools. He told me that
he would try to perform the studies, to hold onto the blood cultures
and he would give me instructions as to how to send them. After some
time, he told me he would not be able to perform the studies and
indicated the laboratory would be shut down. I was quite disturbed and
asked if there was anything I could do. I subsequently wrote to the VA
hospital administration in Pittsburgh protesting this action, as well
as Senator Specter and some in the Pennsylvania Congressional
Delegation. I later found out, much to my dismay, that the isolates
from the whole collection were destroyed. I eventually wrote the
Viewpoints piece for the journal Clinical Infectious Disease, which is
the official clinical journal of the Infectious Disease Society of
America. I have appended the Viewpoints article for submission with my
testimony.
With respect to the research done by Dr. Yu and Dr. Stout, one can
only conclude that it is of the highest caliber in the world. They are
internationally recognized for their work and expertise in Legionella
as well as other pathogens and their laboratory set the standard for
our understanding of the environmental control for Legionella. If I may
read into the record part of the Viewpoints piece, I believe the
Committee will get a flavor for the value of the collection.
``Dr. Yu established a series of national and international
collaborations to elucidate our understanding of the microbiologic and
clinical management issues of bacteremia due to many different
organisms. These studies were seminal in many respects. They changed
our understanding of the relationship between appropriate and
inappropriate therapy, the relationship between the minimum inhibitory
concentrations of isolates to outcome, and the molecular epidemiology
of relapse and reinfection as well as relatedness of strains throughout
the world. The studies are far too numerous to articulate in detail or
even list here in total, but they include studies of the major
pathogens that confound us today, including Staphylococcus aureus (6-
8), Pseudomonas aeruginosa (9), extended spectrum beta-lactamase
producing Klebsiella pneumoniae (10-12) Enterobacter species (13),
Stenotrophomonas maltophilia (14), Enterococcus species (15,16),
Bacteroides fragilis (17), Streptococcus pneumoniae (18-20), and
Candida species (21-23). The concept was simple, observe the clinical
presentation of bacteremia or fungemia, and follow outcomes while
correlating the microbiology to the outcome. The studies were all
prospective and the isolates collected and sent to a central laboratory
(the Pittsburgh VA special pathogens laboratory) for more definitive
analysis. Each of the studies emanating from this collection has
changed our knowledge base and contributed significantly towards
optimal management of patients with these infections.
Capturing the isolates and making sure they were sent was an
important and difficult task--especially for fastidious organisms like
S. pneumoniae and Bacteroides species. Given the international
component, as well the requirements for sending specimens across
national borders, these studies were difficult to perform. All studies
were approved as per local IRB requirements and permits were obtained
from regulatory authorities. Nevertheless, the number of studies and
important insights total well over a 100 peer-review articles and have
provided important information that correlates outcome with the use of
certain antibiotic classes as well as levels of susceptibility. Some of
the studies have challenged prevailing dogma and helped provide data
for the CLSI.
I also go on to point out ``These isolates were accrued purely for
the advancement of science and the beneficiaries of these studies were
the patients infected by these microbes. Moreover, these isolates and
samples would have proven invaluable in the future in that these
strains would enable comparison over time for changes in pathogen
virulence, antimicrobial susceptibility correlation with outcome, and
changing genetic diversity as well as the development of new molecular
tests.''
The value of the collection is that it was linked to clinical
outcomes. This kind of collection does not really exist anywhere in the
world and these studies are really quite difficult to organize and
complete. The reason this is so important is that one can correlate
microbiologic factors to clinical outcomes, and with a large number of
patients and specimens to study, one can control for confounding
variables such as underlying host factors, which might relate to the
clinical outcome. The committee should also note that one of our
studies on pneumococcal bacteremia was given a national award at the
annual meeting of the Infectious Disease Society of America, the
Emanual Wolinsky award, as the best clinical paper for the year. The
studies which were foreclosed by the destruction of these isolates
included any study of new pathogenic factors that might be related to
microbial pathogenesis in a variety of organisms, changing microbial
diversity which we recognize as continually evolving, and factors that
might relate to antimicrobial resistance and susceptibility. While
these organisms exist in nature and can be grown from the environment
as well as people, the fact that there was a collection of organisms
linked to outcomes made the collection invaluable to science.
It would have been relatively simple to maintain the collection
since many organisms are maintained in freezers in a holding solution.
Some agreement should have been entered into between the parties that
wanted to close the lab and Dr. Yu and Dr. Stout in order to give them
time to make arrangements for transport of the specimens to another
laboratory. To just destroy the specimens as was done was a wanton
thoughtless act. It is for this reason that I wrote my Viewpoints piece
for publication and appended a petition which has been signed by a
number of clinical and microbiologic research scientists throughout the
world.
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Biography for David R. Snydman
David R. Snydman, MD, FACP, is currently Chief of the Division of
Geographic Medicine and Infectious Diseases and Hospital Epidemiologist
at Tufts Medical Center and Professor of Medicine and Pathology at
Tufts University School of Medicine. He went to Williams College and
graduated with highest honors in Chemistry (1968) and graduated from
the University of Pennsylvania School of Medicine (1972) where he was
awarded the Dr. A.O.J. Kelly prize. He was an intern and resident in
medicine at Tufts-New England Medical Center, and spent two years in
the Epidemic Intelligence Service at the Centers for Disease Control.
He was a clinical and research fellow in infectious diseases at Tufts-
New England Medical Center before joining the faculty. He is board
certified in medicine and infectious diseases.
Dr. Snydman has been involved in both antibiotic resistance related
research, epidemiologic research and clinical care for over 30 years.
He has had an ongoing interest in anaerobic infections as well as an
interest in Cytomegalovirus in solid organ transplantation. He
developed Cytomegalovirus Immune Globulin, brought it to licensure and
was awarded a citation from the Massachusetts Department of Public
Health for his efforts. He has been a Teaching and Research scholar of
the American College of Physicians. He has published over 250 peer
reviewed original articles, book chapters and reviews, co-edited 13
Year Books of Infectious Disease, five Yearbooks of Medicine and
published one book. He was the recipient of the Ken Kaplan award, given
annually to the ``outstanding infectious disease clinician'' by the
Massachusetts Infectious Disease Society, and he has also received a
Distinguished Faculty award from Tufts University School of Medicine.
He is also a co-recipient of the Emanual Wolinsky award, given annually
for the best clinical paper published in the Journal of Clinical
Infectious Diseases. He sits on the editorial boards of the Journal of
Transplantation, Journal of Clinical Infectious Diseases, and Mayo
Clinic Proceedings. He is nationally and internationally recognized for
his clinical and microbiologic research in the field of infectious
diseases.
Discussion
The Labeling and Cataloging Characteristics of the Scientific
Collection
Chairman Miller. Thank you, Dr. Snydman.
I understand that Mr. Moreland will testify. His written
testimony submitted last night asserts that none of the samples
were, and this is a quote from the testimony, ``collected,
labeled, cataloged and properly stored to constitute a
scientific collection.'' One of the people who cleaned out the
refrigerators at the lab on December 4 said that the individual
vials had numbers, both numbers and letters on them, and Dr.
Stout has attached to her testimony a catalog that looks, to
our staff, who have more expertise than I do, like a thorough
catalog. Is that how samples are collected, labeled, cataloged
and stored to constitute a scientific collection?
Dr. Snydman. Are you asking me?
Chairman Miller. Yes, Dr. Snydman.
Dr. Snydman. Absolutely. They typically will have a
laboratory number that will refer in a notebook or some other
central repository the linkage. For a couple of reasons that is
done. One is to protect the identity of the individual from
whom the isolate has been obtained, and also to have kind of a
linear catalog that can refer to specimens and they are usually
grouped in boxes in freezers so that they can be ascertained
for subsequent analyses as needed. So that is very typical.
Chairman Miller. All right. And Dr. Stout, were the numbers
and letters part of our cataloging of the collection?
Ms. Stout. Yes, and for those of you who have never seen a
scientific collection, I wanted to show you with this visual
aid. There are 81 little compartments in these boxes and this
is what a freezer vial, and what we would write on the side is
the number and some information about the material in there. We
would write the same number on the top so that when someone
went into the box, they could see easily where they wanted to
go to find the isolate, and then each of these boxes was put
into a stainless steel rack and that rack held 20 individual
boxes. Our collection of microorganisms were stored in this
very orderly manner.
Chairman Miller. Okay, and that is a standard procedure in
cataloging?
Ms. Stout. That is a standard procedure, and in our
procedure manual--which the laboratory service had, because we
were under laboratory service when we were performing clinical
testing--it is the standard operating procedure describing that
process.
Chairman Miller. Your testimony has established well, as
has our staff report, that there was a great deal of peer-
reviewed research that resulted from research on this
collection. Is a proper catalog of samples necessary for peer-
reviewed research, Dr. Stout?
Ms. Stout. Absolutely. One of the examples that I provided
to the Committee was a paper where we were using new molecular
tests to link the organisms from hospital water systems to
patients. It is called pulse field gel electrophoresis. And
that group of organisms was retrievable from the freezer
because we had cataloged those organisms and we could go back
and use new tests to evaluate those new tests, and in fact, we
have had requests from other scientists for those very
organisms, and in the publication is the stock number that is
on the vial in the freezer and those individuals in other
countries have asked for those organisms for further study.
Chairman Miller. Dr. Snydman, do you agree with what Dr.
Stout just said? Is proper cataloging a necessary part of peer-
reviewed research?
Dr. Snydman. Yes, I would say absolutely.
Chairman Miller. So if this collection were not properly
cataloged, it would not have resulted in the number of peer-
reviewed articles that it appears to have resulted in?
Dr. Snydman. Absolutely.
Chairman Miller. Okay. Dr. Stout, when did you first hear
these criticisms of your collection, that it wasn't done
scientifically, it wasn't collected or labeled or cataloged or
properly stored to make it a real scientific collection?
Ms. Stout. I believe I was told that by the Committee staff
after they had conducted interviews, and I didn't find that to
be a credible statement.
Chairman Miller. You never heard it from Dr. Melhem?
Ms. Stout. No.
Chairman Miller. You never heard it from Mr. Moreland?
Ms. Stout. No, and I never had any direct conversations
with them. I believe they have claimed that they asked me for
information about the catalog collection and no one from either
the research department or the clinical laboratory asked me for
specific information. When I was in the process of working with
the research group to make the transfer, all they were
concerned about was the paperwork and, you know, they were
apparently trying to help me do that.
Chairman Miller. Dr. Yu, when did you first hear these
criticisms of how your collection was cataloged, that it wasn't
scientific?
Dr. Yu. I wrote many communications to them, and the
letters are documented in the Appendix. I never heard anything
from them, and I never heard this particular excuse used to
justify destruction of the organisms.
Chairman Miller. Dr. Melhem never told you before or told
you to your face or even in an e-mail, that is----
Dr. Yu. That is right.
Chairman Miller.--kind of like to your face, that there was
some failure in the way that the collection was collected,
labeled and cataloged and stored?
Dr. Yu. Yes. I never had any communication with Dr. Melhem.
Chairman Miller. My five minutes have expired. Mr.
Rohrabacher.
Mr. Rohrabacher. Thank you very much, Mr. Chairman, and
again, I appreciate your leadership in directing your staff to
come to this as early as you obviously have. I am a former
journalist and I remind people that journalists really, we know
this much about that much, but we don't know this much about
anything, and I have to admit, some of the words that were
being used today, I don't know what those words were and I am a
man of words.
Chairman Miller. I thought that Dr. Snydman was just
showing off.
The Special Pathogens Laboratory (SPL)
Mr. Rohrabacher. So let me ask a couple questions here
about the nature of your laboratory. There are two natures to
the laboratory that we are talking about. One is a research
component and the other is a diagnostic and clinical component
that basically services other hospitals. Is that right?
Dr. Yu. I was also head of the Clinical Microbiology
Laboratory and that laboratory handles specimens from the local
VA hospitals, and then I was also head of the Special Pathogens
Laboratory and that is a research laboratory. However, since we
had outbreaks of Legionnaires' disease within our own hospital
initially, sometimes there was interaction between the two. But
the publications and the personnel in the Special Pathogens
Laboratory were the main component of the research.
Mr. Rohrabacher. The research has been going on since 1976,
or how long?
Dr. Yu. The Special Pathogens Lab really started in
approximately 1979 to 1980, and that was when----
Mr. Rohrabacher. Okay, so it has been going on since 1979
or 1980 and that is----
Dr. Yu. Yes.
Mr. Rohrabacher.--28 years, almost 30 years now.
Dr. Yu. Yes.
Mr. Rohrabacher. And during that time period, you have
managed to actually discover the cause of Legionnaires' disease
and identify this--what do you call it, bacilli or----
Ms. Stout. Bacteria.
Mr. Rohrabacher. Okay, bacteria, that actually has resulted
in these deaths and these horrible problems for people. How
long ago was it that that was discovered?
Dr. Yu. Janet made the first discovery that it could be
contracted from hospital water. It was published in 1982 in the
New England Journal of Medicine and in 1983 in the Lancet.
Mr. Rohrabacher. So, number one, let me just note, I, like
everybody else, thought it was the air conditioning up until
right now. If indeed you come to a point where you have
identified what the cause is and you have had over 20 years of
research into that, was there a need for further research as
compared to utilizing the resources for diagnostic and helping
with specific patients? Was there a need for further research
on this?
Dr. Yu. As a specific example, microbes are evolving and
antibiotic resistance is now a major problem, and it turns out
actually just two days ago we received commentary from one of
my colleagues in France. They believe that Legionella has the
capability to evolve resistant to levofloxacin, and they wanted
us to test their hypothesis with the organisms that we had in
our collection.
Mr. Rohrabacher. So the actual--the discovery was made
years ago but the ongoing research is vitally important because
these things, these bacteria change and we need to keep on top
of it. Is that it basically?
Dr. Yu. Exactly.
Ms. Stout. And if I may just add, in addition to therapy
and treatment, we are also and have been for many years trying
to put the tools in the toolbox to prevent the disease, which
includes treatment of water distribution systems with various
methods to control the presence of the bacteria in water, and
just like with antibiotics, there is no perfect solution so we
continuously do research to perfect those techniques.
Mr. Rohrabacher. Let me note, I think that is very worthy
research. We are going to be talking to someone in the Veterans
Administration who you have been pointing to, decisions that he
made, later on. What if he tells us that that research is
something that he supports but isn't within his budget?
Ms. Stout. Well, I am sure Dr. Yu has something to say, but
what is interesting to me is that in the September issue of
Clinical Infectious Diseases, there is a report demonstrating
that there is an increase in the incidence or the number of
cases of Legionnaires' disease that have been noted, and that
document is, I believe, the last document in your report here.
Mr. Rohrabacher. First of all, let me just say that I would
be supportive of this research. This research sounds like it is
very important. I am trying to make sure that we are not
totally villainizing a man who we have given, and people we
have given the responsibility to run certain budgets and----
Ms. Stout. Well, I think the other point to be made is that
veterans are disproportionately affected by this disease.
Mr. Rohrabacher. And----
Dr. Yu. And one other point. We receive funding from
industry for the levofloxacin study and actually the first
effective disinfection measure was placed at the Pittsburgh VA.
The Los Angeles VA tried some things but the solution came from
Pittsburgh. All of those disinfection systems were put in
gratis, and the levofloxacin and azithromycin, the other major
antibiotic that we discovered effective for Legionnaires'
disease, VA patients got the medicine for free from the
pharmaceutical industry. So we actually brought funding into
the Pittsburgh VA, and that was one of the reasons that we were
made a special clinical resource center because we were--we
could actually bring in funds.
Mr. Rohrabacher. Well, again, it sounds like the research
is really important and I have no doubt, and I would imagine no
one disagrees with that, that the research is very important.
You also serve an important function in your diagnostic help
for people who actually have contracted that, and sometimes we
do give people the authority to try to make decisions based
on--and budget decisions sometimes lead people to do crazy
things, so we will have to take a look and hear the whole
testimony, but thank you very much and thank you for your good
work. I know you have saved lots of lives. I appreciate that
very much.
Ms. Stout. Thank you.
Chairman Miller. Thank you, Mr. Rohrabacher.
Dr. Broun.
Why Was the Special Pathogens Laboratory Closed?
Mr. Broun. I want to remind my colleague from California
that we are all ignorant about some things.
I thank you all for y'all's work. I am a practicing
physician, and I certainly understand the importance of the
clinical work that you are doing and how levofloxacin and
azithromycin have been very instrumental in treating not only
Legionnaires' disease but many others that my patients have
enjoyed the fruits of y'all's efforts. I would like to ask Dr.
Yu and Dr. Stout individually, why do you think y'all's lab was
closed?
Dr. Yu. We asked that question in writing and it is the
letter in the appendix, why would you do this. I did want to
say it had nothing to do with funds because we were bringing in
funds from EPA and industry and so forth, and other
laboratories that needed the work, they actually paid a small
fee too. I don't know the answer but I think the people behind
me can answer that question. It is inexplicable why that
happened.
Mr. Broun. Dr. Stout, do you have any knowledge or even
speculation why the lab was closed?
Ms. Stout. I think probably most of the people reading the
information that has been provided and collected by the staff
come down to the same question that you are asking because it
is essentially inexplicable, given the value of the laboratory,
not only for the clinical laboratory but the other infectious
disease physicians that were practicing not only at the
Pittsburgh VA but nationwide. We served that function and we
supported them not only with regard to Legionella detection and
diagnosis but also in their other investigations of other
pathogens. I am reminded of a term about shortsighted
businessmen where they act before they actually understand the
scope and the value of that which they are proposing to cut. So
I believe that there was a failure at all levels within this
administration to not only protect the value of the laboratory
but the value of the collection.
Mr. Broun. Are either of you familiar with any of the
processes or procedures that are required for a VA lab closure?
Ms. Stout. I have read the document that was associated
with the research centers of excellence and that there was
terminology in there about orderly closure and having plans for
those closures, yes.
Mr. Broun. Dr. Yu.
Dr. Yu. Yes, I was well aware of that, and actually I had
to go through an interrogation. I pointed out the specific
memorandum in my interrogation that one of the points that they
made is that there was no mandate for this laboratory,
something that was again so incredibly difficult to comprehend
since the previous director had actually mandated that, and I
pointed this out to Mr. Moreland and his group.
Mr. Broun. Do either of you all know if the policies and
the procedures for VA lab closures were followed in this case
with SPL?
Dr. Yu. The policy says that you have to arrange for
orderly closure to ensure that patients are not affected and so
forth, and that clearly wasn't done. It was a strike of
lightning that I think really caught Senator Specter's eye as
to that just didn't seem right, that a lab that is there for 30
years is there on Wednesday, you close it on Friday.
Mr. Broun. So it is your contention that those procedures
and policies that are put in place for VA lab closures were not
followed in this case with SPL?
Dr. Yu. They were not followed.
Mr. Broun. There were clinical specimens that were
undergoing those studies for antibiotic resistance or for
identification and those types of things that were shut off
without any final determination of what that isolate was, what
any kind of antibiotic treatment was or anything else. Is that
correct?
Dr. Yu. That is correct.
Mr. Broun. Would this, in your opinion, open some liability
for patient safety?
Dr. Yu. It turns out that there was a major affiliated
hospital of one of the most prestigious universities in the
United States had sent specimens to us and that individual was
so perturbed when we were unable to give him the results when
all we had to do was open the cabinet and look at it under the
microscope, he wrote me a letter saying you have done great
work but go out on the high road, give me those results. We
sent that communication to the administration and to Senator
Arlen Specter, and Specter asked them to release the results.
They let those cultures die. But I understand a settlement was
made with the Pittsburgh VA and the water contractor or water
consultant who had sent the specimens to our laboratory, but
that is what I heard. So they paid off this individual who
actually, I think, was very, very concerned about the
implications of not following through on a commitment.
Mr. Broun. Thank you. My time has expired. Thank you, Mr.
Chairman.
Chairman Miller. Thank you. The Chairman welcomes both Dr.
Broun's expertise and his use of the word ``y'all.''
I now recognize myself for a second round of questions. Mr.
Moreland, his written testimony and presumably his oral
testimony under oath later today, will be that he was shocked,
shocked to learn that there was research going on in his
laboratory. Dr. Stout, I understand that part of your work
including the research on the Legionella at that hospital, that
VA hospital, resulted in your playing a significant role in
developing a protocol for reducing the risk of Legionella in
the VA hospital system. Is that correct?
Ms. Stout. That is correct.
Chairman Miller. Okay. Did the VA embrace that work? Did
they know that you were doing it there? Did they say what on
Earth were you doing, doing research.
Ms. Stout. It is difficult for me to understand how the
administration of the hospital in which we worked was
completely unaware of the work that we had been doing for more
than 25 years. The basis for the VA directive which was
published in February of 2008 came from our work and came from
direct collaboration with the VA medical inspector general.
That piece of information was among the various pieces of
information provided to the administration as justification for
our continuing to serve the VA and the Nation. So I am not sure
exactly when Mr. Moreland said that he was unaware but he
certainly was aware of our accomplishments including that
before they made the decision to close the laboratory.
Transferring the SPL Collection
Chairman Miller. Okay. Just a couple of other questions
about Mr. Moreland's written testimony. These can be very quick
answers, yes or no. His testimony is that, ``Following a
technical review by the ACOS for clinical support, we found it
presented a potential biohazard to both employees and our
veterans. The SP lab lacked a defined and approved research
activity.'' Dr. Yu or Dr. Stout, did anyone ever tell you that
there was a technical review and a finding that your research
or the maintenance of this collection presented a potential
biohazard?
Ms. Stout. No.
Chairman Miller. When did you first hear that?
Dr. Yu. Now.
Chairman Miller. Right now this minute? Okay. Dr. Yu, Dr.
Stout, you apparently conducted months of negotiations on the
transfer of this collection to another facility where you could
continue your research. Could you describe fairly briefly those
negotiations, Dr. Yu or Dr. Stout?
Ms. Stout. I probably should do that because it was my
communication with the research department at the VA from
August to December. There were numerous documents, mostly e-
mails between myself and the research department. The first was
with Dr. Graham, then Dr. Sonel subsequently and then Dr. Sonel
directed one of his individuals, the research compliance
officer, to work with me to effect that transfer, and if I may
just correct a misconception, both Dr. Graham and Dr. Sonel
each had conversations with Dr. Melhem in which she led them to
believe that it was her intention to destroy the collection.
Therefore, they were forewarned. It was not the fact that
although they were misled in December, they all had an
opportunity to protect the collection as early as September
when they were informed of her intention to destroy it.
Chairman Miller. Dr. Snydman, you have worked with Dr. Yu.
You are an infectious disease researcher yourself, which is why
you were able to show off rattling off the names of all those
bacteria. Our second panel will be about policies and protocols
of what perhaps should happen. It appears that a great many
laboratories do not necessarily have written protocols but
there is sort of a habit or common sense, common decency of
seeing first if there is another researcher at the same
institution when a researcher is leaving that would use the
samples for their research, whether the researcher who is
leaving would take it with them or whether it could be given to
be somebody else if there is no one there that would continue
the research or has any interest, and it is only if no one, no
researcher appears to have any interest at all that samples are
destroyed. Is that consistent with your own impression of what
happens?
Dr. Snydman. I would say yes. In general, if there is
someone who is taking over or collaborating, there would be
some preservation and transport of the specimens, but if there
isn't anyone else, they might be destroyed.
Chairman Miller. All right. Are you aware of other
instances when a research institution destroyed a specimen
collection without consulting with the research staff?
Dr. Snydman. No.
Chairman Miller. Are you aware of any circumstances--well,
this seems to be a redundant question but if redundancy is a
sin, all politicians are going to hell. Do you know of any
circumstances in which or can you imagine a research
institution destroying a collection while there were
negotiations underway for what to do with the collection?
Dr. Snydman. No.
Chairman Miller. Mr. Rohrabacher.
Reasons for Destroying the SPL Collection: Procedural Flaws or
Personality Conflicts?
Mr. Rohrabacher. Thank you, Mr. Chairman, and again, we are
novices here in a number of ways, both in terms of the subject
of your research and also in exactly how the structure works.
First of all, I take it that your laboratory worked
somewhat independently because--and that up until now you
really haven't had any close relationship with top people in
the Veterans Administration.
Ms. Stout. I would say literally that would be not true
because over the years I participated in numerous activities
through the VA central office infectious disease group, as did
Dr. Yu, and we were asked to be lecturers and to participate in
the development of guide books on infectious diseases.
Mr. Rohrabacher. But would that be people at the top, at
the very top level of the VA or just people who are operating
within the VA?
Ms. Stout. Not in Pittsburgh, in Washington, that----
Mr. Rohrabacher. Yes, but I mean----
Ms. Stout. Yes.
Mr. Rohrabacher. Okay. First of all, you have accomplished
a lot and we should all be grateful for that, and when I
mentioned earlier that bureaucracy gets in the way of all this
stuff, here in Washington you can trace things down to just the
way people operate and rules of bureaucracy within a certain
parameter there, and let me ask you this. There are controls
that laboratories in the NIH and CDC and others whose only area
is research and not necessarily helping with hospitals like you
are also doing, but there is a lot of controls on human subject
research. Now, are you--have you been under that same sort of
umbrella of regulations as to how you can operate as would
happen under the labs of NIH or CDC?
Ms. Stout. Yes. For example, the Environmental Protection
Agency study involved interactions with patients so it was
approved by the IRB as well as the VA Merit Review study and
numerous other studies by Dr. Yu.
Mr. Rohrabacher. Okay. So you are not just operating out on
your own and----
Ms. Stout. No.
Mr. Rohrabacher.--ignoring what all the other labs have to
do because they are under----
Ms. Stout. No, and in fact, there was tremendous oversight
over what we did from very different bodies.
Mr. Rohrabacher. All right. That is really an important
element here because I think what we are being told is that
somebody asked for a raise, which got somebody's attention, and
all of a sudden they had never--somebody had not realized that
you existed before. Frankly, if I had not realized that you
existed before and then heard that you had been involved with
such important work, I would be very happy and I would have
tried to be your friend and take credit for everything you did.
So the fact is, that is the way it works in Washington quite a
bit, and instead, it seems here that personalities have come
into play and that what often we see in Washington also within
the bureaucracy is, at times people get a little bit miffed
that their authority is being challenged in some way. Do you
think that there is a personality end of this about people
worrying that rather than looking at the value of what you are
doing, that they were only looking at maybe their authority was
being challenged?
Ms. Stout. Well, what I am heartened by is the work that
the Chairman and the Committee will do to prevent this from
ever happening again.
Mr. Rohrabacher. Right.
Ms. Stout. I think that there were some checks and balances
available within the administration in Pittsburgh to prevent
this from happening and they were completely disregarded.
Mr. Rohrabacher. And was that due to, as I say, people
getting miffed or a personality situation being brought into
what should have been a professional situation, or was this a
real flaw in the system?
Ms. Stout. I think it was both. I think hat there were
people in the administration that cared more about themselves
than science, medicine or veterans. I think that what the
Committee has shown and the hard work of the staff is that the
measures that we had faith in and we were working in good faith
with the research department to transfer the collection, the
atmosphere in this administration prevented them from acting
respectfully and responsibly.
Mr. Rohrabacher. Well, certainly any lab that is shut down
should be--anybody who is told--with research as important as
yours should be given enough advance notice that these type of
problems, that the disaster that we are talking about wouldn't
have happened. So thank you very much.
Ms. Stout. Thank you.
Chairman Miller. Thank you. I think we have gotten from you
the particular points we wanted covered in your testimony, but
I am a recovering lawyer, and it occurs to me that you all have
been wronged. Obviously others have been wronged too. We will
never know who has been wronged. We will never know that
someone who died from an antibiotic-resistant staph infection
might not have died had your specimens not been destroyed, but
you all have been wronged professionally. Have you talked to a
lawyer?
Dr. Yu. I have talked to a lawyer.
Chairman Miller. Okay.
Dr. Yu. But so far, I am still recovering psychologically
from this blow, frankly.
Chairman Miller. Well, I am certainly not dispensing legal
advice but my sense of how the law has developed over the last
several hundred years is that some conduct, some event strikes
us as unjust in our viscera, something seems unjust to us, and
then we engage our intellect to explain why it is unjust, and
from that comes legal concepts, whether it is the law of
property or of contract or of tort, you all have suffered an
injustice, and I would encourage you to talk about whether you
might have some redress from that.
Dr. Yu. Are you still practicing?
Chairman Miller. I am not. There is an election in less
than two months. It is my hope that I will have some continuity
of employment here----
Ms. Stout. You have our vote.
Chairman Miller.--and I will be unavailable to practice
law. Thank you.
Ms. Stout. Thank you.
Chairman Miller. Mr. Rohrabacher, anything else?
Mr. Rohrabacher. I have one last point and that is when I
first ran for office, my most successful slogan during my first
campaign was, ``Vote for Dana, at least he is not a lawyer.''
Ms. Stout. Well, I am glad you all have a sense of humor.
We appreciate it very much.
Chairman Miller. Thank you, and I thank all of you. We will
now have our next panel, and we will have about a two-minute
break while you all step down and the next panel steps up.
[Recess.]
Panel II:
Chairman Miller. I would now like to introduce our second
panel. Dr. Jim Vaught is the Deputy Director of the Office of
Biorepositories and Biospecimen Research at the National Cancer
Institute. Dr. Janet Nicholson is the Senior Advisor for
laboratory science at the Coordinating Center for Infectious
Diseases at the Centers for Disease Control and Prevention. You
each have five minutes for your oral testimony, and your
written testimony will be included in the record of the
hearing. When you complete your testimony, we will have
questions. Each Member will have five minutes. We will proceed
in rounds of five minutes each. It is the practice of the
Subcommittee to take testimony under oath. Do either of you
have an objection to being sworn in, to swearing an oath? Both
have said or nodded no. The Committee also provides that you
may be represented by counsel. Are either of you represented by
counsel at today's hearing? Both have said or nodded no. Please
stand and raise your right hand. Do you swear to tell the truth
and nothing but the truth? Both witnesses did so swear.
Dr. Vaught, please begin.
STATEMENT OF DR. JIM VAUGHT, DEPUTY DIRECTOR, OFFICE OF
BIOREPOSITORIES AND BIOSPECIMEN RESEARCH, NATIONAL CANCER
INSTITUTE, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Dr. Vaught. Thank you, and good morning, Mr. Chairman, Mr.
Rohrabacher, Members of the Subcommittee. I am Dr. Jim Vaught,
the Deputy Director of the Office of Biorepositories and
Biospecimen Research, or OBBR, at the National Cancer
Institute, part of the National Institutes of Health, an agency
of the Department of Health and Human Services. I have been
engaged in the area of biospecimen research and biorepository
management for over 15 years and I have participated in the
development of a number of practices and policies relevant to
today's discussion. This testimony will highlight four specific
activities relevant to the hearing topic; one, the NCI Best
Practices for Biospecimen Resources; two, a trans-NIH effort to
develop a policy framework for biospecimen collections; three,
the NIH Scientific Directors Subcommittee on Biorepository
Practices and Guidelines within the Intramural Research
Program; and four, the Interagency Working Group on Scientific
Collections. These activities were triggered in part by the
acknowledgement that the value of biospecimens and other
scientific research collections is not always recognized and
that these collections need to be managed in an optimal way.
Substandard practices can have a negative impact on research
studies as well as the practice of medicine.
In September 2007, the HHS produced a personalized health
care document that recognized the critical importance of
biospecimens to the research infrastructure that will support
personalized medicine. The vision of personalized medicine is
one in which the standard of medical care is improved by adding
an individual's genetic and molecular profile to the decision-
making process. With the support of senior NCI leadership, the
OBBR worked in a highly collaborative manner with many NIH and
external experts to develop the NCI Best Practices for
Biospecimen Resources. For the purpose of today's discussion,
the recommendations in Section C-1 of the Best Practices
concerning custodianship of specimen collections are the most
relevant.
We consider the custodianship issue to be so important that
we sponsored a workshop on ownership and custodianship issues
in biospecimen research in October 2007 which resulted in a
series of more specific recommendations that we are considering
for incorporation into the next version of the NCI Best
Practices.
The NIH Scientific Director's Subcommittee was formed to
make recommendations to the scientific directors concerning
biorepository practices and policies within the NIH intramural
research program. As a result of the work of this subcommittee
during 2006 and 2007, the NIH published guidelines for human
biospecimen storage and tracking within the NIH intramural
research program. These guidelines make specific
recommendations regarding one, the transfer of specimen
custodianship and informed consent information when the
responsible investigator leaves NIH or when the custodianship
needs to be changed for other reasons; and two, reporting
requirements for the specimen inventory and tracking systems
being used.
In addition, NIH intramural investigators were directed in
a June 2006 memorandum to include in their institutional review
board packages the manner that specimens are stored, tracked
and what will happen to the specimens at the completion of the
protocol. As a result, any decision to destroy or transfer
specimens out of NIH is carefully monitored by scientific
directors as well as IRBs. At NIH, the specimens obtained
belong to the government, not the researcher. Plans to move
materials outside NIH must include appropriate material
transfer agreements and must be approved. NIH policy does not
permit a scientist leaving the NIH to disperse his or her
materials without review.
A federal-wide Interagency Working Group on Scientific
Collections (IWGSC) was formed in response to a call from the
White House Office of Science and Technology Policy and the
White House Office of Management and Budget for federal
agencies to address the scientific, environmental, societal and
national security needs for collections. As we had found in our
assessment of the NCI and NIH collections, the IWGSC survey
found that federal agencies often do not have standardized,
comprehensive approaches to the long-term management and use of
their scientific collections. The working group is evaluating
recommendations that are consistent with NIH long-term
management principles.
In conclusion, since many such collections are priceless
and irreplaceable, adoption of practices such as those
developed by NCI and other groups that I noted will be critical
if we are to preserve them in the condition necessary to make
the scientific discoveries and medical advances for which they
were collected. Based on these considerations, the NCI Best
Practices reflect the following themes with respect to
developing a custodianship plan at the beginning of a study or
program: one, appoint a custodian to address long-term
management of specimen collections; two, manage conflicts of
interest; three, follow all applicable regulations and
policies; and four, include plans for management after a study
ends, funding is lost or similar situations requiring
custodianship changes. These are extremely important issues
concerning critical resources that are central to our
biomedical research infrastructure.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Vaught follows:]
Prepared Statement of Jim Vaught
Good morning Mr. Chairman, Mr. Sensenbrenner and Members of the
Subcommittee. I am Dr. Jim Vaught, the Deputy Director of the Office of
Biorepositories and Biospecimen Research (OBBR\1\ ) at the National
Cancer Institute (NCI), part of the National Institutes of Health
(NIH), an agency of the Department of Health and Human Services (HHS).
I have been engaged in the area of biospecimen research and
biorepository management for over 15 years, and I have participated in
the development of a number of practices and policies relevant to
today's discussion. This testimony will highlight four specific
activities relevant to the hearing topic.
---------------------------------------------------------------------------
\1\ NCI Office of Biorepositories and Biospecimen Research (OBBR)
web site: http://biospecimens.cancer.gov/
---------------------------------------------------------------------------
In 2007, NCI published its Best Practices for Biospecimen
Resources, which provide guiding principles that define state-of-the-
science biospecimen resource practices, promote high standards of
biospecimen and data quality, and facilitate compliance with ethical
standards and legal requirements. NCI has also been involved in a
trans-NIH effort to develop a policy framework on legal and ethical
issues that would apply to all NIH-supported human specimen
collections. Additionally, I have been an active participant in the NIH
Scientific Directors Subcommittee on Biorepository Practices and
Guidelines within the Intramural Research Program, formed in 2006 to
address biospecimen storage and tracking practices and policies at
laboratories at NIH facilities. The recommendations of this group are
currently being implemented.\2\ In 2005, I was appointed to a federal-
wide Interagency Working Group on Scientific Collections (IWGSC). This
working group is a subcommittee of the Committee on Science (COS),
within the National Science and Technology Council (NSTC), managed by
the Office of Science and Technology Policy (OSTP). Our charge has been
to identify resources and requirements, including research and
development needs, for long-term stewardship of these collections, and
to foster coordination of collections-related activities across the
Federal Government.
---------------------------------------------------------------------------
\2\ NIH Intramural Research Program Biospecimen Guidelines: http://
www1.od.nih.gov/oir/sourcebook/oversight/
Biospecimen%20Storage%20and%20Tracking%20Guidelines%2020080717.pdf
---------------------------------------------------------------------------
These aforementioned activities--the development of the NCI
biospecimen best practices document, the NIH guidelines for the
intramural program, the trans-NIH policy framework on legal and ethical
issues and the federal-wide Working Group--were triggered in part by
the acknowledgment that the value of biospecimens and other scientific
research collections is not always recognized and that these
collections need to be managed in an optimal way. Substandard practices
can have a negative impact on research studies as well as the practice
of medicine. In a September 2007 report on Personalized Health Care,\3\
HHS also recognized the critical importance of biospecimens to the
research infrastructure that will support personalized medicine. The
vision of personalized medicine is one in which the standard of medical
care is improved by adding an individual's genetic and molecular
profile to the decision-making process.
---------------------------------------------------------------------------
\3\ Personalized Health Care: Opportunities, Pathways, Resources.
U.S. Department of Health and Human Services, http://www.hhs.gov/
myhealthcare/
---------------------------------------------------------------------------
Scientists can now study cancer at the most fundamental level,
identifying genes and their functions in the body, called genomics, and
studying the corresponding set of proteins programmed by the genetic
code, called proteomics. At NCI we recognize the critical role that
biospecimens play in these endeavors. OBBR's mission is to ensure that
human specimens are available for cancer research and that they are of
the highest quality. The OBBR is responsible for developing a common
biorepository infrastructure that promotes resource sharing and team
science, in order to facilitate multi-institutional, high throughput
genomic and proteomic studies. These types of studies will lay the
groundwork that will lead us to personalized medicine.
With the support of NCI senior leadership, our office worked in a
highly collaborative manner with many NIH and external experts to
develop the NCI Best Practices for Biospecimen Resources. Following a
careful analysis of NCI's biological specimen practices, NCI sponsored
two workshops in 2005 that resulted in a series of recommendations
that, along with existing guidelines, regulations and best practices
from other organizations, became the NCI Best Practices. The Best
Practices include recommendations from technical and ethical/legal
standpoints. I have provided the full document to the Committee, but
for the purpose of today's discussion, the recommendations in Section
C.1 of the Best Practices, concerning custodianship of specimen
collections, are the most relevant. We consider the custodianship issue
to be so important that we sponsored a workshop on Ownership and
Custodianship Issues in Biospecimen Research in October 2007, which
resulted in a series of more specific recommendations\4\ that we are
considering for incorporation into the next version of the NCI Best
Practices.
---------------------------------------------------------------------------
\4\ NCI OBBR Ownership and Custodianship in Biospecimen Research
Workshop summary: http://biospecimens.cancer.gov/global/pdfs/
CaOSumm.pdf
---------------------------------------------------------------------------
The NIH Scientific Directors Subcommittee was formed to make
recommendations to the Scientific Directors concerning biorepository
practices and policies within the NIH Intramural Research Program. As a
result of the work of this subcommittee during 2006 and 2007, NIH
published Guidelines for Human Biospecimen Storage and Tracking within
the NIH Intramural Research Program. These Guidelines make specific
recommendations regarding: 1) the transfer of specimen custodianship
and informed consent information when the responsible investigator
leaves NIH or when the custodianship needs to be changed for other
reasons; and 2) reporting requirements for the specimen inventory and
tracking systems being used. In addition, NIH intramural investigators
were directed in a June 2006 memorandum to include in their
Institutional Review Board (IRB) packages the manner that specimens are
stored, tracked, and what will happen to the specimens at the
completion of the protocol.\5\ As a result, any decision to destroy or
transfer specimens out of NIH is carefully monitored by Scientific
Directors as well as IRBs. At NIH, the specimens obtained belong to the
Government, not the researcher. Plans to move materials outside NIH
must include appropriate material transfer agreements and must be
approved. NIH policy does not permit a scientist leaving the NIH to
disperse his/her materials without review.
---------------------------------------------------------------------------
\5\ June 12, 2006 memorandum from Dr. Michael Gottesman: Research
Use of Stored Human Samples, Specimens or Data: http://
www.nihtraining.com/ohsrsite/info/DDIR.html
---------------------------------------------------------------------------
The federal-wide IWGSC was formed in response to a call from the
White House Office of Science and Technology Policy (OSTP) and the
White House Office of Management and Budget (OMB) for federal agencies
to address the scientific, environmental, societal, and national
security needs for collections. The Working Group's main activity to
date has been to conduct a survey to examine the current state of
federal scientific collections and to assess general thematic issues
regarding collections management and stewardship. These collections are
highly variable, from NIH's human biological specimens to NASA moon
rock collections and Smithsonian museum artifacts (for example, from
the Lewis and Clark Expedition). A report is being prepared to outline
the Working Group's findings. As we had found in our assessment of the
NCI and NIH collections, the IWGSC survey found that federal agencies
often do not have standardized, comprehensive approaches to the long-
term management and use of their scientific collections. The IWGSC is
evaluating recommendations that are consistent with NIH long-term
management principles.
In conclusion, there is broad agreement that collections of
biological specimens, as well as other collections of materials of
scientific value, are critical to the research enterprises that
support, among other important endeavors, advances in the medical and
technological fields. As such, standardized, high quality management
practices and long-term plans for custodianship of these collections
are needed. Since many such collections are priceless and
irreplaceable, adoption of practices such as those developed by NCI and
other groups that I noted will be critical if we are to preserve them
in the condition necessary to make the scientific discoveries and
medical advances for which they were collected. We are mindful that
when patients and other study participants agree to provide blood or
other samples for a research study, they generally do so with an
expectation that their tissue will be used to provide insight into the
causes and/or cures of their disease, or to advance medical research in
general.
Based on these considerations, the NCI Best Practices reflect the
following themes with respect to custodianship of biospecimens:
1. At the beginning of a study or program that will include
biospecimen or other research collections, a custodian, either
a person or a governance committee, should be appointed by the
institution to develop a plan for addressing long-term
management of specimen collections.
2. Responsible custodianship requires appropriate management
of financial or scientific conflicts of interest that may
interfere with appropriate judgment concerning the proper
disposition of the collection, and the most appropriate
scientific and/or medical use of the specimens.
3. All applicable regulations and policies concerning, for
example, privacy, informed consent, and material transfer must
be followed in decisions concerning the disposition of
specimens and data.
4. Custodianship plans should state in detail how specimen
collections will be managed or dispersed when funding is lost,
custodial management changes, or protocols are completed,
including careful consideration of the future scientific value
of the collection. The plan should recognize that specimens
that are no longer valuable or necessary for their original
purpose may be useful for other purposes, consistent with the
requirements of informed consent and other applicable rules and
policies.
These are extremely important issues concerning critical resources
that are central to our biomedical research infrastructure.
We appreciate the opportunity to provide our views, Mr. Chairman.
Thank you, and I would be pleased to answer any questions.
Biography for Jim Vaught
Dr. Vaught has a Ph.D. in biochemistry from the Medical College of
Georgia, and has been with the National Cancer Institute for almost 10
years. He has been involved in the field of biorepository and
biospecimen science for over 15 years. In 1999 he was one of the
founding members of the International Society for Biological and
Environmental Repositories (ISBER) and was its second President. He
participated in the development of ISBER's Best Practices for
Repositories, as well as the NCI Best Practices for Biospecimen
Resources and the OBBR's other strategic initiatives. Since 2005 he has
served as one of NIH's representative to the Interagency Working Group
on Scientific Collections, which was created by the White House Office
of Science and Technology Policy. He also served as a member of the NIH
Intramural Scientific Directors Biorepository Committee. In addition to
ISBER, Dr. Vaught is a member of the American Association for Cancer
Research (AACR), the Association for Laboratory Automation, the
American Society for Pharmacology and Experimental Therapeutics and the
American Association for Clinical Chemistry. He is Senior Editor for
Biorepository and Biospecimen Science for the AACR journal Cancer
Epidemiology, Biomarkers and Prevention, and a member of the editorial
board of the ISBER journal Cell Preservation Technology. He has been
invited to write book chapters about biospecimen science and policy
issues, as well as speak at national and international conferences on
these topics.
Chairman Miller. Dr. Nicholson.
STATEMENT OF DR. JANET K.A. NICHOLSON, SENIOR ADVISOR FOR
LABORATORY SCIENCE, COORDINATING CENTER FOR INFECTIOUS
DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Nicholson. Thank you, and good morning, Mr. Chairman
and other distinguished Members of the Subcommittee. I am Dr.
Janet Nicholson and it is my pleasure to be here in my capacity
as senior advisor for laboratory science to the director of the
Coordinating Center for Infectious Diseases at CDC. I have
nearly 20 years of experience working inside CDC's infectious
disease laboratories and have provided expert guidance on
infectious disease laboratory-related activities. I have also
represented the CDC laboratory community on complex,
overarching infectious disease-related scientific issues
including specimen collection, use and storage. I have co-
authored 95 research or review papers and have delivered
roughly 80 presentations in the fields of emerging infectious
diseases, laboratory response to bioterrorism threats and
immune responses to HIV infection. I currently serve as the
U.S. representative for the Global Health Security Action Group
Laboratory Network as a member of the Trans Federal Task Force
for Optimizing Biosafety and Biocontainment Oversight, as an ex
officio member of the National Science Advisory Board for
Biosecurity, and the President-Elect on the Board of Directors
for the Clinical and Laboratory Standard Institute, or CLSI.
I am pleased to appear before you this morning to address
CDC's laboratory specimen collections. I would like to give a
brief overview on CDC's management of infectious disease
specimens and then I would be happy to answer your questions.
Each year CDC laboratories receive hundreds of thousands of
human and environmental specimens from its various partners in
public health throughout the United States and abroad. Many of
these specimens contain organisms or products that need to be
identified. Other specimens are unique population-based
collections. Virtually all of these specimens are automatically
archived because of their potential importance to public health
and safety. Upon receipt at CDC, specimens are logged in,
tracked and examined. In the Coordinating Center for Infectious
Diseases, my coordinating center, specimens are logged, tracked
and reporting is managed by an automated system called Star
Limbs. Any given specimens or samples we receive may be
entirely consumed by the testing process or sufficient
quantities may have been obtained for storage. In the case of
diagnostics work, reports of laboratory results from tests done
on these samples are provided to the submitter or other
appropriate authorities. At times, portions of the samples may
be placed in long-term storage and are retained for future use.
In extremely rare circumstances, some of our archived specimens
may be destroyed because of lack of relevance, loss of
viability during storage, lack of appropriate documentation,
space limitations or when IRB, or the Institutional Review
Board regulations, require so.
Maintaining CDC's world-renowned culture collections of
specimens is essential in carrying out the agency's public
health functions, that is, to detect, control and prevent
morbidity and mortality from diseases. CDC manages its
specimens in a manner commensurate with the scientific
integrity required by HHS guidelines and policies. Each
collection has a curator, as you heard before, whose
responsibility is to create, maintain and oversee the use of
these special collections. These specimen collections are
unique and unmatched anywhere in the world. Not only are they
critical to CDC's mission, they are also critical to our
commitment to the global community to serve as a reference
diagnostic center. The collections support the work
accomplished in our nearly 30 World Health Organization
collaborating centers for reference research on virus,
bacteria, parasites and fungi.
Rare and irreplaceable collections of specimens are stored
at CDC. Some of these historical collections date back to
before 1945, which was before the era of antibiotics. CDC
routinely performs reference and research activities on rare
and unusual and novel bacterial and viral pathogens. This
specialized work requires comparison of the new unknown
organism to isolates of these archive strains with similar
characteristics. Through this work, new pathogens such as SARS
may be discovered when novel isolates are shown to be unrelated
to any archived organism or DNA sequences on record. We would
not be able to conduct our comprehensive work on pathogen
discover without these valuable strain collections.
In the early 1990s, CDC and the Agency for Toxic Substances
and Disease Registry, or ATSDR, developed a specimen repository
that provides for secure, long-term storage and management of
our valuable collection of specimens. The CDC-ATSDR Specimen
Packaging Inventory and Repository, or CASPIR, is a significant
resource for the management of specimen collections at CDC
because it provides unique archival space and utilizes a
documented management system for these archives. The CASPIR
policy board developed policies which include admission of
specimen collections, ensuring data quality and security,
documenting data and specimen sharing, specimen and data
withdrawal and use, human subjects review issues, review of
specimen usage and disposal of unwanted specimens, and
contingency and disaster management. Each collection must be
unique and not redundant of other collections already stored.
CDC's diagnostic laboratories are certified under the
standards of the Clinical Laboratory Improvement Amendments of
1988, or CLIA. CLIA requires specific policies and procedures
regarding the collection, testing and storage of specimens. CDC
conducts research on human specimens. The research plans for
this work to include information about the procedures for the
collection, testing and storage of these specimens.
To protect our collections, CDC's specimen archival storage
facilities and containers consist of freezers at -70 degrees
centigrade and liquid nitrogen containers that are monitored 24
hours a day, seven days a week, with up to three responsible
people to be notified in the case of an alarm that would
indicate a problem with temperature control that could threaten
the contents. To further guard some of our bacterial
collection, CDC and the American Tissue Culture Collection, or
ATCC, have a verbal agreement that new and reclassified strains
of certain bacterial pathogens are placed into the ATCC
collection so that organisms are available from the ATCC to all
scientists for purchase to use in their research.
Specimens at CDC that are collected for the purpose of
human research must comply with the basic HHS policy for
protection of human research subjects. CDC investigators who
collect and use human specimens are required to receive
training in scientific ethics for investigators who engage in
research using human subjects. Unless exempt by certain
classifications identified in the human subjects research
policy, all such research must be approved by an institutional
review board, IRB, prior to start of the research and specimen
collection. IRB guidelines require that research protocols
specify the disposition of remaining specimens after the
completion of the research. The principal investigator must
request permission from the participants via informed consent
to store the remaining specimens for future use.
In closing, CDC reference collections are a core component
of our mission, unique in the world and absolutely critical to
research in medicine and public health. Storage and subsequent
disposal of the specimens are carefully managed. These
specimens provide the agency with the ability to not only
detect, respond to and control diseases today but are vital to
unraveling tomorrow's unexpected disease crises.
Thank you for the opportunity to appear before the
Subcommittee to share this information with you about our
invaluable specimen archives and our critical work in
protecting public health. I would be happy to answer any
questions.
[The prepared statement of Dr. Nicholson follows:]
Prepared Statement of Janet K.A. Nicholson
Good morning, Chairman Miller, Mr. Sensenbrenner, and other
distinguished Members of the Subcommittee. I am Dr. Janet Nicholson,
and it is my pleasure to be here today in my capacity as Senior Advisor
for Laboratory Science for the Coordinating Center for Infectious
Diseases (CCID) at the Centers for Disease Control and Prevention
(CDC), an agency of the Department of Health and Human Services (HHS).
In addition to advising the Director of CCID on all laboratory-related
science issues, I also serve as the designated federal official for the
CCID Board of Scientific Counselors, and the Co-Chair for the steering
committee for the design and construction of four CDC Laboratory
Buildings. I have co-authored 95 research/review papers and have made
80 presentations in the fields of emerging infectious diseases,
laboratory response to bioterror threats, and immune responses to HIV
infection. I also currently serve as the U.S. representative for the
Global Health Action Group Laboratory Network, as a member of the Trans
Federal Task Force for Optimizing Oversight of Biosafety, and as the
President-Elect on the Board of Directors for the Clinical and
Laboratory Standards Institute.
I am pleased to appear before you this morning representing the
CDC, the Nation's leading public health protection agency, to address
the CDC's Laboratory Specimen Collections.
CDC Policies and Procedures Governing the Collection and Study of
Specimens:
Each year, CDC laboratories receive hundreds of thousands of human
and environmental specimens from its various partners in public health
throughout the United States and abroad. Many of these specimens
contain organisms or products that other laboratories could not
identify, and virtually all of these specimens are automatically
archived because of their potential importance to public health and
safety. These specimens are collected for the purpose of detecting,
controlling, and preventing morbidity and mortality from diseases.
Specimens are used for a variety of purposes, including research,
pathogen discovery, diagnostics, reference diagnostics, vaccine
development, and supporting external scientific research activities
within multiple National Centers across CDC.
Upon receipt, CDC logs, tracks, and examines these specimens and
provides reports of any laboratory tests to the submitter of the
specimen or other appropriate authorities. Specimen logging, tracking,
and reporting is managed by our automated Specimen Tracking and
Retrieval Laboratory Information Management Systems (STARLiMs). Any
given specimens or samples we receive may be entirely consumed by the
testing process, or portions may be stored for safekeeping or retained
for future use. In extremely rare circumstances, some of our archived
specimens may be destroyed because of space limitations, lack of
current relevance, loss of viability during storage, lack of
appropriate documentation, or when required by an Institutional Review
Board (IRB).
Maintaining CDC's world renowned culture collections of specimens
is essential to carrying out the agency's core public health functions
to detect, control, and prevent morbidity and mortality from infectious
diseases. CDC manages its specimens in a manner commensurate with the
scientific integrity required by HHS guidelines and policies. These
policies and guidelines include, but are not limited to, the HHS Public
Health Service Policies on Research Misconduct (42 CFR Part 93)\1\ and
the HHS Protection of Human Subjects regulations (45 CFR Part 46).
Laboratories also have guidelines specific to the types of specimens
collected, as most collections must be handled in very specific and
often unique ways, for example, CDC's ``West Nile Virus: Guide for
Clinicians,'' and CDC's ``Instructions for Testing by the Division of
Vector-Borne Infectious Diseases Bacterial Zoonoses Diagnostic
Laboratory.'' \2\ Each collection has a curator, whose responsibility
is to create, maintain, and oversee the use of these special
collections. These specimen collections are unique and unmatched
anywhere in the world. They are critical to CDC's mission and to our
commitment to the global community as a reference diagnostic center, as
well as supporting the work accomplished in our nearly 30 World Health
Organization (WHO) Collaborating Centers for Reference and Research on
viruses, bacteria, parasites, and fungi.
---------------------------------------------------------------------------
\1\ Some of the areas covered in this policy include: ``Protection
of the confidentiality of respondents, complainants, and research
subjects identifiable from research records or evidence, consistent
with'' 42 CFR 93.108; and, ``A thorough, competent, objective, and fair
response to allegations of research misconduct consistent with, and
within the time limits of the final rule, including precautions to
ensure that individuals responsible for carrying out any part of the
research misconduct proceeding do not have unresolved personal,
professional, or financial conflicts of interest with the complainant,
respondent, or witnesses,'' as explained at http://ori.hhs.gov/
policies/Requirements-Reg-6-05.shtml
\2\ http://www.cdc.gov/ncidod/dvbid/misc/
bacterial<INF>-</INF>zoonotic<INF>-</INF>shipping.htm
---------------------------------------------------------------------------
Rare and irreplaceable collections of specimens stored at CDC are
subject to the limitations of research resources that could block our
ability to uncover the benefits to health and medicine that are
contained in these specimens, some representing historical collections
pre-1945 (pre-antibiotic era). For example, CDC routinely performs
reference and research activities on rare, unusual, and novel bacterial
pathogens. This work requires comparison of the new, unknown organism
to isolates of archived strains with similar characteristics. New
pathogens are discovered when novel isolates are shown to be unrelated
to any archived organism or DNA sequence on record. We would be unable
to conduct our comprehensive work on pathogen discovery without these
valuable strain collections.
The CDC's diagnostic laboratories save and store the significant
organisms they identify; the laboratories are certified under the
standards of the Clinical Laboratory Improvement Amendments (CLIA) of
1988 and currently have policy statements and guidelines regarding
archival and storage of laboratory specimens. Under CDC's Laboratory
Quality Management System (QMS) approach to carrying out our laboratory
science, all laboratories are required to document their policies and
processes for specimen collection, disposal, and storage. The QMS is
part of CDC's ongoing work to achieve even higher quality standards and
is aimed at standardization of policies to the extent that is possible,
given the distinct nature of each laboratory. CDC also is a
participating member of the National Science and Technology Council's
Interagency Working Group on Scientific Collections. CDC's specimen
archival storage facilities and containers consist of -70<SUP>+</SUP>C
freezers and liquid nitrogen containers that are monitored twenty-four
hours a day, seven days a week, with up to three contacts available and
listed on each storage container, should an alarm indicate a problem
with temperature control that could threaten the contents. To further
protect our collections, CDC and the American Type Culture Collection
(ATCC) have an oral agreement that new and reclassified strains of
enteric bacterial pathogens are placed into the ATCC collection so that
the organisms are available from the ATCC to all scientists for
purchase to use in their research.
Specimens at CDC that were collected for the purposes of human
subjects research must comply with the HHS Protection of Human Subjects
regulations (45 CFR Part 46). This includes specimens collected for
research conducted by CDC employees or supported by CDC through funding
or provision of other tangible support whether conducted inside or
outside the United States. CDC investigators who collect and use these
specimens are trained in compliance with the regulations that apply to
investigators who engage in research using human subjects. Unless
exempt, under the HHS regulations for the protection of human subjects,
all research involving human subjects must be approved by an IRB prior
to the start of the research and specimen collection. CDC IRBs are
composed of members from various scientific disciplines including
health fields, social sciences, methodology, laboratory sciences and
toxicology; and non-scientific disciplines, including ethics,
education, administration and youth advocacy. Most IRB panels have
members with specialized knowledge of the interests of pregnant women,
children, prisoners, and other categories of vulnerable groups and
individuals, to protect them from inappropriate or unethical treatment.
Each of CDC's seven IRBs is composed of 12 to 16 members, and at least
one to three of these members are not affiliated with CDC. The
guidelines of the CDC IRBs require that protocols specify the
disposition of remaining specimens after completion of the research,
and the principal investigator must request permission from the
participants via informed consent to store the remaining specimens for
future use, unless that requirement is waived by the IRB or the samples
have been stripped of identifiers. These are common industry best
practices.
How CDC laboratories evaluate the continuing need for, and scientific
value of, the collections of specimens in its
laboratories:
CDC reference collections are a core component of our mission,
unique in the world, and absolutely critical to research in medicine
and public health. When assessing archival specimens, we take into
consideration a number of factors, including the needs of special
patient populations (such as HIV-positive individuals, intensive care
unit patients, ethnic populations, and women); novel or emerging agents
of disease compared to archival isolates; pathogen discovery; pre-
antibiotic era isolates (pre-1945); epidemics or pandemics;
confirmation or development of taxonomic additions or changes; and
correlation of new isolates to disease. CDC evaluates the value of
particular collections based on the uniqueness of the isolate, its
potential value in future studies, and especially the quality of
supporting data that accompanies the collection. Additionally, the
number of external requests for archived samples is another indicator
for the need of our collections. These materials are readily available
to requestors through Material Transfer Agreements (MTAs) that outline
roles and responsibilities of both the provider and recipient. Last
year, for example, CDC executed approximately 200 MTAs for materials in
our collections.
Collections are only as good as the clinical and epidemiological
information available for the specimens. Clinical data can identify
specimens from persons with well-defined diseases, or persons well-
defined as ``healthy'' individuals. Some rare collections may represent
historical importance documenting the first introduction of a disease
caused by a particular strain. For example, our virus collections were
critical when CDC responded to the world-wide outbreak of Severe Acute
Respiratory Syndrome (SARS) in 2003. Other collections allowed CDC to
recognize the agent of Legionnaires' disease in 1977 as a newly defined
organism and to trace its origins. Diagnostic tests and laboratory
identification procedures developed by CDC are validated using dozens
of archived isolates as well as specimens from both normal donors and
donors that are identified with specific diseases, such as influenza
and respiratory syncytial virus.
Currently most of our laboratories have no uniform protocols in
place regarding the destruction of specimen archives. When necessary,
destruction occurs only after study and consultation and in a very
controlled and documented manner. Indeed, we never want to purposely
dispose of rare collections, and it is uncommon that any are destroyed.
The establishment of the CDC and Agency for Toxic Substances and
Disease Registry (ATSDR) Specimen Packaging,
Inventory and Repository (CASPIR) and its
contribution to specimen resource management at the
CDC.
In the early 1990's, CDC/ATSDR developed a specimen repository that
provides for secure, long-term storage and management of our valuable
collections of specimens. The CDC/ATSDR Specimen Packaging, Inventory
and Repository (CASPIR) is a significant resource for the management of
specimen collections at CDC because it provides archival space not
available on the main CDC campus and utilizes a documented management
system for these archives.
The roles of CASPIR are to: 1) ensure each collection has a
scientific curator who is responsible for the information in the
collection and who approves the use of the collection by persons or
groups outside of the scientific program that collected the specimens;
2) ensure the quality of the specimens in storage by monitoring freezer
temperatures and responding to alarms caused by temperature changes; 3)
provide a single electronic database for the inventory; 4) provide a
secure location for the specimens; 5) ensure that when investigators
leave CDC, the collection is assigned to another CDC investigator; and
6) facilitate sharing of specimens, associated clinical and
epidemiological data, and test results. CASPIR places critical record
keeping in the hands of archivists, not busy laboratorians, and thus
ensures availability of unique isolates to national and international
research
Policies and procedures were developed through a CASPIR Policy
Board. These policies include: apportionment of available storage
space; admitting specimen collections; cataloging collections; ensuring
confidentiality; ensuring data quality; documenting data and specimen
sharing; ensuring data security; specimen and data withdrawal and use;
additional testing of specimens; human subjects review issues; review
of specimen usage and disposal of unwanted specimens; physical security
of specimens; and contingency and disaster management. Storage space is
allocated to a CDC program based on requests from each program, and
space is reapportioned when necessary.
Collections for research are admitted to CASPIR when they meet
basic criteria and have the appropriate approvals from CDC's National
Center directors or their designees. The mandatory criteria for
acceptance include submission of the following information: study
design; study sites; duration of the study; study population; and a
copy of the informed consent form for the overall study. Additional
information needed includes whether epidemiological or clinical data
were collected; types and number of specimens collected; types of tests
performed directly on the study participants or the specimens; and
contact information for the custodians of the collection. Lastly, each
collection must be unique and not redundant of other collection already
stored. Individual isolates will be stored in CASPIR only if they are
deemed to be unique and cannot be easily recreated.
In addition to this information about the study, there are
additional explicit mandatory criteria about the samples themselves for
specimens to be deposited to CASPIR. The specimens must be sera, plasma
lymphocytes, other body fluids, separated white blood cells, nucleic
acids, cultures of microorganisms, or other miscellaneous biologicals.
They must be of a certain volume, age, and condition, to ensure that
meaningful testing can be performed on the specimen if retrieved at a
later date. There also must be sufficient volume of remaining specimen
to be of value for testing. When appropriate, the method of specimen
collection that was used is included. An important example of this
information would be the type of anticoagulant in which the specimen
was collected. Sterility and viability must be documented. Finally, the
specimens must be in storage vessels appropriate for the proposed
storage condition. For example, the use of glass vials is not
appropriate unless storage is in a refrigerator.
Detailed information about the collection is necessary for the
specimens to be meaningful. This information includes: the name and
contact information of the custodian and designated organizational
contact if there is a recommendation to discard the collection; a brief
description of the project and study design and why the activity led to
the collection; information about the source of the specimens; the age
and time period of the collection; the geographical location or
locations where the specimens were obtained; the study population
(e.g., uranium workers in New Mexico); demographic data such as age,
gender, race, and ethnicity; whether the collection was the result of a
research project and the consent form used, if available; types of
tests performed directly on the study participants or the specimens;
and, types, number, and volume of specimens in the collection.
Acceptance of collections requires completing a form with all the
information noted above and with written approvals from the appropriate
CDC officials. Externally-obtained collections are not accepted into
CASPIR unless a National Center shares ownership of the collection and
can assist in technical and scientific decisions regarding the use of
the collection.
Distribution of specimens from the collection takes into
consideration that though the investigators are custodians of the
collection, CDC is the ultimate owner. This policy helps to assure that
the investment made by CDC to conduct critical studies and analyze
valuable specimens will be securely maintained. When collections are
accepted into the CASPIR facility, a determination is made as to the
availability of the collection for use by those outside of the
scientific program that is the custodian. Each National Center must
then establish a review process for requests of materials, including a
process for assuring that IRB approval is obtained before human
specimens will be provided for non-exempt human subjects research.
Release of specimens and associated data must be approved by the
National Center. There are provisions for appeals of denials of
approvals.
All specimen and data bank information is treated in a confidential
manner and safeguarded in accordance with the Privacy Act and any other
applicable laws, regulations, and policies.
National Centers are required to review the usage of their
collections annually to ensure the periodic disposal or transfer of
materials that they determine are no longer used or needed. Before
disposal or transfer, the appropriate CDC program officials must
provide descriptions of the excess specimen collections to other
National Centers, institutions, or organizations affiliated with the
collection through the Associate Director for Science at CDC. Any
disposal or transfer of specimens that can be directly linked back to
the study subject must be consistent with what was stated in the
consent form. When appropriate approvals are given, the recipient
organization becomes the custodian of the collection and assumes
responsibility for it. Any destruction of specimens must follow current
biosafety guidelines established by CDC and the National Institutes of
Health.
Conclusion
In closing, CDC reference collections are a core component of our
mission, unique in the world, and absolutely critical to research in
medicine and public health. CDC takes its use of and subsequent storage
and disposal of specimens seriously. These specimens provide the agency
with the ability to not only detect, respond to, and control diseases
today but are vital to unraveling tomorrow's unexpected disease crises.
Thank you for the invitation to appear before the Subcommittee to
share this information with you about our invaluable specimen archives.
I would be happy to answer any questions.
Biography for Janet K.A. Nicholson
Prior positions: Acting Deputy Director, National Center for Infectious
Diseases (NCID), CDC; Associate Director for Laboratory Science, NCID;
Deputy Chief, Immunology Branch, Division of HIV/AIDS, NCID; Research
Chemist, Immunology Branch, Division of Immunologic, Oncologic, and
Hematologic Diseases, NCID; Postdoctoral Fellow, Division of
Immunology, Bureau of Laboratories, CDC; Research Scientist, Emory
University; Research Technician, University of Texas Medical Branch;
Research Technician, University of Nebraska Medical Center.
Education: B.S., Buena Vista College; Ph.D., Emory University.
Honors: Charles C. Shepard Science Award; Excellence of research,
National Student Research Forum; McLaughlin Award in infectious
diseases and immunology, National Student Research Forum; President's
Award, Association of Public Health Laboratories (awarded twice);
Centennial Achievement Award, University of Iowa Hygienic Laboratory;
John Fischer Alumni Award, Buena Vista University. Invited speaker at
over 70 national and international conferences.
Significant National activities: Ex officio member, National Science
Advisory Board for Biosecurity; Member, Interagency Biosecurity
Subcommittee of Select Agent Committee; President-elect, Board of
Directors, delegate, and subcommittee member, Clinical and Laboratory
Standards Institute (CLSI), [formerly National Committee for Clinical
Laboratory Standards (NCCLS)]; Member, Infectious Diseases Committee,
Association of Public Health Laboratories; Coordinator, ASM/NCID
Postdoctoral Fellowship; Member, Laboratory Response Network (LRN)
Joint Leadership Council; President, Advisor, and Counselor, Clinical
Cytometry Society; Former Member and past Chair, Flow Advisory
Committee (FAC) for NIAID; Editorial Boards of Communications in
Clinical Cytometry and Clinical and Diagnostic Laboratory Immunology;
Member of six professional societies.
International activities: U.S. representative for the Global Health
Action Group Laboratory Network; Member, Framework Initiative for a
Safe and Secure Society (U.S.-Japan initiative); Expert, Biological
Weapons Convention Expert Meeting on Biosecurity, 2003; Involved in
efforts to develop alternative technologies for CD4 enumeration through
WHO; Invited speaker at 15 international conferences.
Scientific interests: Emerging infectious diseases; laboratory response
to bioterror threats; immune responses to HIV infection.
Publications: Author/co-author of over 95 research/review papers.
Additional significant activities: Co-chair, core team/steering
committee for design and construction of four NCID/CCID Laboratory
Buildings; CDC Co-lead for Laboratory Coordination of Anthrax Events of
2001; Public Health Leadership Institute, Year 12 Class.
Discussion
Scientific Collection Disposal at NCI and CDC
Chairman Miller. Thank you. Both of you gave testimony that
was reassuring that our agencies, the procedures for the
disposition of scientific collections are done with some care
and some thoughtfulness, some thought. Can you assure the
Subcommittee that a similar incident would not have occurred at
your institution? Dr. Vaught?
Dr. Vaught. Well, the NCI and the broader NIH have spent a
lot of time in the past few years trying to put policies into
place to anticipate and manage collections so that they are
collected, processed and stored in an orderly way, and I
believe the policy that has been most effective in this has
been established within the last two years by the NIH and its
intramural program that I mentioned where IRB packages and
institutional review board packages have to have a
custodianship plan included for specimens and data. When an
investigator leaves NIH or otherwise something changes that
causes the custodianship of the sample collection to change,
then that has to be done in an orderly way. If the person goes
outside NIH, then there are material transfer agreements that
control transferring specimens and data outside of NIH, and if
some change occurs within NIH, then there is agreement among
various investigators to change the principal investigator who
will lead and control the specimen collection. So we believe we
have those issues covered in that way.
Chairman Miller. Dr. Nicholson, would the CDC have
destroyed a collection in the circumstances that you have heard
occurred here?
Dr. Nicholson. CDC has a similar approach to NIH in this
regard. Quite honestly, the investigators at CDC have a very
hard time removing any specimens from the collection and it is
a very difficult decision when that would happen.
Chairman Miller. Dr. Vaught, your testimony is that we need
long-term plans for custodianship, really very standardized and
excellent management practices, many of the collections really
are irreplaceable and priceless, and that other agencies need
systems in place, procedures in place, protocols in place like
what NCI has. Would a Congressional directive to establish such
policies and implement the policies throughout the various
federal agencies that do such research help that goal?
Dr. Vaught. Well, I think there is no easy answer to that.
I think the basic principles that I laid out that NCI and NIH
use are very good ones for custodianship of specimen
collections. I believe, Mr. Chairman, you touched in your
earlier opening statement on the interagency issues, that the
OSTP created this Interagency Working Group on Scientific
Collections and we found in that group that I think it is
something like only 35 or 40 percent of the agencies that
reported have standard operating procedures and policies for
managing long-term management of their collections. But we have
to remember that scientific collections include not only the
biological specimens that I mentioned for NIH but also in my
written testimony I mentioned that the moon rock collections
that NASA manages, for example, the Smithsonian artifacts from
the Lewis and Clark expedition have to be managed and these are
all important collections for different reasons so they would
have differing management policies, depending on the type of
collection that is involved. So I think it would be difficult
to write a policy that covers all the bases there but I think
it is probably something to be followed up with by this
interagency working group.
Chairman Miller. But biospecimens in particular, biobanking
in particular, it does seem that they are somewhat different
from the artifacts of the Lewis and Clerk expedition. Would a
directive from Congress to adopt a standard set of policies
help make sure--which obviously has not happened. Would it help
that happen?
Dr. Vaught. Well, I think we have to remember that there
are already policies and regulations in place including the
federal regulations that govern informed consent from the
Department of Health and Human Services and also the
regulations and rules within NIH and other agencies that govern
material transfer agreements, so you already have a basis for
creating custodianship policies. So the question I think would
be whether you go beyond the existing IRB and informed consent
rules and regulations and the existing material transfer
agreement regulations and create something that is beyond that.
I think there are already good policies in place to handle most
of these kinds of situations.
Chairman Miller. Are you aware of such policies at the VA?
Dr. Vaught. Actually I don't know--I know very little about
the VA's policies. The informed consent policies that Dr.
Nicholson and I operate under are governed by what is called
the Common Rule, and that is a HHS regulation.
Chairman Miller. My time is expired. Mr. Rohrabacher.
Should the SPL Been at the VA?
Mr. Rohrabacher. Thank you, Mr. Chairman.
I take it that both of you knew that the major area that we
were supposed to be looking at here today, the reason you are
here, is to give us a broader image, a broader view as well,
which you have and I appreciate that, but I would like to ask
your opinion on this case. I believe that first of all the
research that was being conducted which we now know contributed
greatly to saving human life and is very admirable and positive
research for the country and for the well-being of our people,
should that research have been VA research or should it have
been under NIH or CDC?
Dr. Nicholson. CDC does have a Legionella lab that does
research. I don't know enough about what the VA's mission is to
determine whether or not CDC should also do that type of
research.
Mr. Rohrabacher. So the CDC could well have offered an
alternative to encompassing this research and bringing them in?
Dr. Nicholson. I am not the Legionella expert so I don't
know what the focus of the research in our Legionella lab is so
I can't really say.
Mr. Rohrabacher. All right. What about with NIH?
Dr. Vaught. Well, I think I am even further removed from
that. NIH has something like 26 or 27 institutes. One of them
is the National Institute of Allergic and Infectious Diseases,
NIAID, and NIAID works closely with the CDC on infectious
disease issues, but I couldn't say whether this would fall
under NIAID's mission or not.
Mr. Rohrabacher. Were the people involved and was the lab
that is now being looked at--you have listened to the testimony
and I don't know if you read the testimony to come or not but
is it your professional opinions that the job that they were
doing met your professional standards?
Dr. Vaught. I honestly don't know enough about this
situation to comment on that. I have of course read some of the
testimony and background papers and so forth but really my
major conclusion was that this was an issue of custodianship
and so I have tried to address that from NCI and NIH's point of
view and hopefully those sorts of policies and procedures that
we developed at NIH would be applied in other situations but I
really----
More on Scientific Collection Disposal at NCI and CDC
Mr. Rohrabacher. We are talking about custodianship in a
period of transition as well. They were closing the lab and who
then and what those procedures should be and how to make sure
situations don't arise like this in which some very damaging
decisions were made that ended up with the destruction of
materials that could well have served us and served the lives
of human beings in a very important way, and what would you say
to that?
Dr. Nicholson. I don't really have any more to add. I also
don't know any more than we just heard this morning about this
particular case.
Mr. Rohrabacher. And have any of your organizations had
run-ins with the administration like this before?
Dr. Vaught. Run-ins with our administration?
Mr. Rohrabacher. With people who are overseeing you within
the administration for budgetary reasons making decisions that
could lead to a negative impact.
Dr. Vaught. Well, I can only say from my own experience
that there are policies and procedures developed at NIH for
closing labs and an orderly transfer of equipment, materials
and personnel. Those decisions are made above my pay grade but
they happen.
Mr. Rohrabacher. So there are decisions that you think that
are in place at NIH that would have prevented this destruction
of these specimens?
Dr. Vaught. I can only say that I believe that we have
orderly processes in place at NIH.
Mr. Rohrabacher. What about the CDC in this?
Dr. Nicholson. For the long-term collections, yes, that is
absolutely the case. There are policies and procedures in place
to ensure that appropriate approvals are received in order to
destroy specimens.
Mr. Rohrabacher. Well, I won't try to put you on the spot
anymore because I understand the position you are in, but let
us just--again, I realize, like I stated in the beginning,
there are bad decisions that are made by people that should be
held accountable. There are also bureaucratic problems that
arise within a governmental approach to problems and
governmental involvement in human activity. So we will find out
what is at the bottom of this but certainly these are people
that have contributed enormously to the well-being of our
people. I mean, Legionnaires' disease, it is a very admirable
thing to come up with some solution for that and some way they
can be treated. We end up with a situation like this and I am
very pleased that the Chairman to focus his attention on this
issue. Thank you very much.
Chairman Miller. Thank you, Mr. Rohrabacher.
Dr. Broun.
Mr. Broun. Thank you all for coming to this hearing today.
As a physician and scientist, I am very concerned about this
issue. I just have a question of each of you. Do you see any
reason, any compelling reason from a scientific perspective why
these specimens should have been destroyed in the way that they
were, from a safety perspective, a health perspective or
anything else? Can you see any reason to just destroy these
specimens the way that they were handled? And I would like both
of you to comment on that, please.
Dr. Vaught. Well, again, I feel like as a scientist that I
really don't know all the facts in this case to make that sort
of judgment. I can tell you that in our experience at NIH,
there are a number of reasons that specimen collections would
be destroyed after a long and careful process of reviewing
their utility. Normally they would be destroyed if they are no
longer useful for their original purpose, or if there isn't
enough sample left to do any further work on. Or if they
presented some other sort of biohazard may be one reason but
usually those biohazard issues can be mitigated by regulations
that are in place at NIH and CDC. So I just have to say that a
lot of thought is given to destroying specimen collections, and
as Dr. Nicholson stated, usually the problem is getting
investigators to let go of their specimens because the tendency
is to want to save them as long as possible and that is why we
have huge warehouses full of freezers out in Frederick,
Maryland.
Mr. Broun. Dr. Nicholson.
Dr. Nicholson. I also don't know enough about this
particular case. I will tell you, I don't have a whole lot more
to add over what Dr. Vaught has said, but within CDC it would
be very rare for a specimen collection to be destroyed. I am
not aware of any of that. It is not all that unusual for
specimens as part of collections to be destroyed because of a
variety of reasons that you may understand and that I had
already outlined.
Mr. Broun. Certainly as a practicing physician, I don't
anticipate my own patients' specimens to be continued on an
ongoing basis once I get the clinical information I need as a
practicing doctor. I make those clinical decisions that I make
and then I don't expect those decisions, but also valuable
research is absolutely critical for antibody development and to
find out about pathogens changing their response to various
anti-microbials, et cetera, and so I just--I can't imagine as a
scientist just destroying a whole set of specimens just without
any regard, particularly those that are involved in patient
care and patient evaluation prior to having a determination
about what the final results of that culture might be. In each
of y'all's opinion, is destroying a specimen prior to
developing the identification and antibiotic sensitivities to
clinical specimens--to me, this seems to be just totally beyond
comprehension. Can you see any compelling reason to destroy
those when you have an ongoing process for clinical specimens
on patients or environmental sources of those specimens prior
to the determination of what the pathogen--well, whether this
is pathogen there, what the pathogen might be and anything to
help in determining how to deal with that pathogen at that
point?
Dr. Nicholson. For clinical laboratories, and CDC does do
reference diagnostic testing, primarily for the State public
health laboratories, we have to abide by CLIA and every CLIA
laboratory has written procedures and protocols about the
collection and the use and the storage of such specimens.
Specimens before they actually have been evaluated to determine
what might be the causative agent may be actually rejected
because they appear to CDC in such poor condition, they were
exposed to high temperatures. There are other physical reasons
for specimens to have never reached the testing component after
they have been collected.
Mr. Broun. But at this point, again, just for the record,
when that determination is made, it is because of inadequacy of
collection materials or that the media has a problem with it or
something else.
Dr. Nicholson. Exactly.
Mr. Broun. It is not because it is a valid specimen that
could be utilized in that investigation. Is that correct?
Dr. Nicholson. Exactly.
Mr. Broun. Dr. Vaught, do you have anything to add?
Dr. Vaught. I don't think so. My experience at the Cancer
Institute is not in infectious disease so our specimens are
collected, for example, for clinical trials and epidemiology
studies where cancer biomarkers are studied, and usually--or
always, there is a study protocol where it is determined what
the specimens are going to be used for, how long they are going
to be saved, and there are primary hypotheses, secondary
hypotheses. When all of those hypotheses are exhausted, then
consideration will be given usually to sharing any additional
specimens that are left over with investigators outside of NIH
or colleagues within NIH. So discarding a sample collection is
usually the last resort when it is no longer useful or there
could be some circumstances where specimens are no longer
useful or they are not in good condition to be used but those
would be, as I said, as a last resort.
Mr. Broun. Thank you very much.
Chairman Miller. Thank you, Dr. Broun.
I think we have no further questions of this panel. Thank
you very much for being here, and we will now take about a 15-
minute break before the final panel. Thank you.
[Recess.]
Chairman Miller. We will wait just a minute or two for Mr.
Rohrabacher.
[Recess.]
Panel III:
Chairman Miller. We are back.
I would now like to introduce our final panel today. Mr.
Michael Moreland is the Director of the Veterans Integrated
Service Network 4 at the Department of Veterans Affairs. Dr.
Mona Melhem is the Associate Chief of Staff and Vice President
of the Clinical Support Service Line for the Veterans Affairs,
Pittsburgh Healthcare System. Dr. Ali Sonel is the Associate
Chief of Staff for the Veterans Affairs Pittsburgh Healthcare
System. Dr. Steven Graham is the Director of the Geriatric
Research, Education, and Clinical Centers at the Veterans
Affairs, Pittsburgh Healthcare System. And Ms. Cheryl Wanzie is
the Chief Technologist for the Veterans Affairs Pittsburgh
System. Dr. Sonel is the Associate Chief of Staff for Research,
specifically, at the Veterans Affairs, Pittsburgh Healthcare
System. I understand that only Mr. Moreland will be giving
prepared testimony today, but the other witnesses will answer
questions that may be directed to them.
Mr. Sonel. Actually, sir, each of the witnesses does have
an oral statement.
Chairman Miller. Oh, all right. We will take the oral
statement. We did not get anything in writing beforehand but
that is fine. As you know, from seeing the earlier two panels,
we do take testimony under oath. Do any of you have an
objection to being sworn in, to swearing an oath? All the
witnesses nodded their head that they had no problem, no
objection. The Committee also provides that you may be
represented by counsel. Do any of you have counsel with you at
the hearing today? All witnesses nodded or said that they did
not have counsel. Now, please stand and raise your right hand.
Do you swear to tell the truth and nothing but the truth? All
the witnesses said or otherwise--all the witnesses are now so
sworn.
Mr. Moreland, you may begin.
STATEMENT OF MR. MICHAEL E. MORELAND, NETWORK DIRECTOR, VA
HEALTHCARE--VISN 4, DEPARTMENT OF VETERANS AFFAIRS
Mr. Moreland. Thank you. Good morning, Mr. Chairman, and
Members of the Subcommittee. Thank you for the opportunity to
discuss the events surrounding the closure of the Special
Pathogens Laboratory at the VA Pittsburgh Healthcare Center. I
am joined today by several colleagues from the VA Pittsburgh
Healthcare System including Dr. Ali Sonel, our Associate Chief
of Research and Development, Dr. Mona Melhem, our Vice
President, Clinical Support Service line, Ms. Cheryl Wanzie,
Medical Technologist, and Dr. Steve Graham, Director, Geriatric
Research and Education Center. And sir, I assume our written
testimonies will all be entered for the record.
Chairman Miller. Mr. Moreland, I believe that only you have
submitted written testimony. It will be submitted in full in
the record.
Mr. Moreland. Thank you very much. Today we will address
the closure of the Special Pathogens Lab, the disposition of
equipment and specimens, and the VA policies as they were in
December of 2006. Additionally, I will discuss some changes
that we have made and instituted in policy since that time.
In January of 2006, the Associate Chief of Staff for
Clinical Support who oversees all of Pittsburgh's laboratory
functions conducted a standard review of the Special Pathogens
Lab workload. This review determined that the main clinical
laboratory would be more efficiently managing these duties. It
also revealed that the Special Pathogens Lab was acting beyond
its intended scope. The lab lacked a defined and approved
research activity and the volume of clinical work being
performed was low. These plus other concerns led us to conclude
that the Special Pathogens Lab would be moved into the main
clinical lab and that additional reviews of the lab's research
accounts would be unnecessary.
The Special Pathogens Lab closed on July 21, 2006.
Approximately two weeks earlier, on July the 5th, the Director
of the lab was notified by e-mail and in person about the lab's
closure, and he and his staff were given two weeks to complete
work currently in process. This notification included
instructions to stop accepting specimens from external
customers. The lab's close-out plans were forwarded to the
lab's staff on July the 7th, and formal letters of notification
were delivered on July the 10th. The members of the lab
received clear direction regarding labeling of existing and new
specimens and stored samples, and the members of the lab were
told to provide a map for this storage. These orders were
specific, but they were ignored.
As the Medical Center Director, I initiated an
Administrative Board of Investigation to review research and
financial activities. The Administrative Board determined that
the lab was operating outside of its established scope of
services and had involved into an unauthorized commercial
enterprise, testing samples for private companies including
hotels, restaurants, and gas stations. It was also engaged in
subcontracting for private environmental companies. The lab had
a commercial client list well into the hundreds.
In September of 2006, we conducted a review of every
publication generated in the lab and concluded its studies
involving human subjects were conducted without required
approval from the Institutional Review Board and/or the
Research and Development Committee. To our knowledge, no
individuals were harmed as a result of this research. We
reported these findings to the VA Office of Research Oversight,
ORO, in October of 2006. They concluded we had adequately
addressed research non-compliance by preventing the lab from
any future research projects, eventually closing the lab, and
establishing safeguards to prevent similar non-compliance in
the future. Following the lab's closure, all properly labeled
and cataloged clinical specimens were moved to the main lab.
Research specimens associated with an approved research
protocol properly labeled and maintained by the principal
investigator were transferred to the main clinical lab for
storage as well. In these specimens that were either not
labeled or not cataloged or properly sealed were considered
biohazardous material and were safely disposed of in accordance
with hazardous material procedures to safeguard patient care
and public health. VA Pittsburgh water samples were transferred
to the clinical laboratory and were sent to an outside vendor
for Legionella testing subsequent to the lab's closure.
VHA policy in December of 2006 clearly stated that if an
investigator leaves the VA facility, the original research
records must be retained at the institution. Moreover, VA
policy instructs that records and information collected and
created by VA personnel, in the conduct of official business,
belong to the Federal Government and not to the employee who
initiated the collection or the creation.
We determined that the samples in question were not
properly labeled and cataloged and did not constitute a sample
of collection. Even if the samples had been properly labeled
and stored, the collection could not have been banked at a non-
VA institution without proper approval.
Following this incident, VA Pittsburgh Healthcare System
has adopted new policy. On October 19, 2007, we issued Research
Data Security and Privacy Policy that specifically outlines
processes for disposition of research and clearly informs
researchers that VA research is the property of VA and that
investigators cannot take the collection away from the VA
without appropriate approval. The VA Pittsburgh Healthcare
System offers a robust research program committed to
contributing to science and enhancing care to veterans in the
broader community. We added compliance staff to increase
research oversight, and leadership is continuing an ongoing,
in-depth review to ensure all VA researchers adhere to the
highest level of human subjects' protection.
That concludes my statement, Mr. Chairman. I will be happy
to take questions.
[The prepared statement of Mr. Moreland follows:]
Prepared Statement of Michael E. Moreland
Good morning Mr. Chairman and Members of the Subcommittee. Thank
you for the opportunity to discuss the events surrounding the closure
of the Special Pathogens Laboratory (SP Lab) at the VA Pittsburgh
Healthcare System (VAPHS). I am joined today by Dr. Ali Sonel,
Assistant Chief of Research and Development, VAPHS; Dr. Mona Melham,
Vice President Clinical Support Service Line, VAPHS; Ms. Cheryl Wanzie,
Medical Technologist; and Dr. Steven Graham, Director, Geriatric
Research and Education Center (GREC).
VAPHS is an integrated health care system serving a population of
over 360,000 veterans throughout Western Pennsylvania, Ohio, and West
Virginia. In Fiscal Year 2007, VAPHS served over 58,000 unique veterans
and completed over 489,000 outpatient visits. Between 2000 and 2007,
the VAPHS research program grew from $11 million to over $24 million in
funded research including an initiative for a VA-led cooperative study;
this growth is indicative of a healthy program that promotes a positive
environment for researchers.
Today I will address the closure of the SP Lab, the disposition of
equipment and specimens, and VA policies as they were in December 2006.
Additionally, I will discuss some changes we have since instituted to
these policies.
Closure of Special Pathogens Laboratory
Let me say at the outset that the Special Pathogens Lab operated
within the VAPHS as a part of the regular clinical laboratory services.
As such, the primary mission was to support the clinical work of the
organization. Its original focus was to perform clinical testing for
Legionella bacteria for the VA.
Further, it should be understood that research projects may be and,
are indeed encouraged, to be undertaken by VAPHS clinicians in the
scope of their VA employment if their protocols are presented and
approved by the Research and Development Committee.
The Research Foundation, an incorporated not-for-profit
organization, has the mission to support VA research operations.
External funding resources are often secured and managed by this
foundation for properly approved and sanctioned activities of VA
researchers.
In January 2006, the Associate Chief of Staff (ACOS) for Clinical
Support, who oversees all VAPHS' laboratory functions, reviewed the
workload of the SP Lab. She determined the clinical workload could be
managed more efficiently within the main clinical laboratory. She also
discovered the SP Lab was acting beyond its intended scope.
Following a technical review by the ACOS for Clinical Support, we
found it presented a potential biohazard to both employees and our
veterans. The SP Lab also lacked a defined and approved research
activity. The volume of clinical work being performed in the SP Lab was
low. The ACOS for Clinical Support determined that this function could
easily be absorbed by the main clinical laboratory at reduced cost. The
supplies necessary to effect such a change were minimal and the
conversion would free up the time of the full-time VA microbiologist to
do other VA work. These concerns were the basis for the ACOS for
Clinical Support's recommendation that the VA work of the SP Lab be
moved into the main clinical lab and that there be an additional review
of SP Lab research accounts.
On July 5, 2006, the Director of the SP Lab was notified via e-mail
and in person about the lab's closure and he and his staff were given
two weeks to complete work currently in progress. This notification
included instructions to stop accepting specimens from external
consumers. The Lab's ``close-out'' plans were forwarded to the SP Lab
staff on July 7, and formal letters of notification were delivered July
10. The SP Lab closed on July 21, 2006. The members of the lab received
clear direction regarding labeling of existing and new specimens and
stored samples, and the members of the lab were told to provide a map
for storage. Although these instructions were specific, they were
ignored.
Investigative Reports
As VAMC Director, I initiated an administrative board of
investigation (ABI) on July 19, 2006, to review research and financial
activities. In addition, I expanded the scope of the investigation on
August 4, 2006, to include investigation of any breach of security and/
or patient privacy surrounding activities in the SP Lab. The ABI
determined the SP Lab was operating outside the scope of services for
which it was established. It had evolved into an unauthorized
commercial enterprise, which tested environmental water supplies for
private companies (including hotels, restaurants, and gas station
bathrooms), and was engaged in subcontracting for private environmental
companies. The SP Lab had a commercial client list in the hundreds that
included private hospitals, businesses, municipal water authorities and
other institutions.
Funds were collected and deposited within the foundation accounts.
As part of an internal financial review at the VA Pittsburgh, financial
concerns were raised. Records indicated that their non-VA invoiced
revenue for 2005 was $396,631.41 and for 2006 was $311,337.71. Since
this was found, the Research Foundation has hired financial staff and
enhanced financial oversight. Non-VA revenue remained unobligated. The
Research Foundation has a procedure in place for left over funds from
research accounts. These funds were pulled into the foundation and used
for other projects.
In September 2006, the VA Associate Chief of Staff for Research,
conducted a review of every publication generated in the SP Lab and
concluded that human subject microbiological diagnostic and
interventional human research studies were conducted at the VAPHS
without required approval from the Institutional Review Board (IRB) and
the Research and Development Committee. To our knowledge, no
individuals were harmed as a result of this research.
We reported all of these findings to the VA Office of Research
Oversight (ORO) on October 12, 2006. In October 2006, after reviewing
these reports of investigations and the actions taken by VAPHS, ORO
concluded the VAPHS had adequately addressed research non-compliance by
suspending the SP Lab from embarking on any future research projects,
eventually closing the lab, and establishing sufficient safeguards to
prevent similar non-compliance from recurring.
Removal of Equipment and Environmental Specimens
Following the closure of the SP Lab, furnishings and equipment
purchased with clinical lab's funds or with VA Research Foundation
funds were moved to the main clinical lab. SP Lab staff were allowed to
transfer equipment acquired by non-VA funds to a site off federal
premises. Properly labeled and cataloged clinical specimens from the SP
Lab were also moved to the main lab. Research specimens associated with
an approved research protocol, properly labeled and maintained by the
principal researchers were transferred to the main clinical laboratory
for proper storage. Those specimens that were not labeled, cataloged,
or were in opened or damaged tubes were considered bio-hazardous
material and were safely disposed of in accordance with hazardous
materials procedures, safeguarding patient care and public health.
VAPHS water samples were transferred to the clinical laboratory. For
approximately two weeks, VAPHS sent water samples to an outside vendor
for Legionella testing. After this period, VA's clinical lab developed
the ability to conduct Legionella testing in-house and currently offers
this service to several other VA Medical Centers.
Policy Governing Disposition of Research
In December 2006, VHA Directive 2000-043 (attached) governed the
disposition of research collections. The Directive and a clarification
memorandum from VHA's Chief Research and Development Officer (CRADO)
addressed the collection and storage of clinical data that could be
linked to the human biological specimens. Two additional policies
discussed record retention. VHA Handbook 1200.05 (attached) states that
``if an investigator leaves a VA facility, the original research
records must be retained at the institution.'' VA Handbook 6300.1
(attached) states that ``records and information collected and created
by VA personnel in the conduct of official business belong to the
Federal Government and not to the employee(s) who initiated their
collection or creation.''
We determined in December 2006 that no VA-approved research
protocol existed to cover the samples in question. The samples were not
collected as part of any previously approved research efforts, nor were
they collected, labeled, cataloged and properly stored to constitute a
scientific collection. Even if the samples had been properly labeled
and stored, the collection could not have been banked at a non-VA
approved institution without a VA investigator.
In response to the investigations of the SP Lab and after the loss
of research data in another VISN, VAPHS took steps to enhance awareness
among staff of VA research and lab policies and procedures. In March of
2007, VAPHS held a two-week Research Stand Down to ensure staff
understood laboratory policies and the importance of securing sensitive
research data.
New Policy Governing Disposition of Research
On October 19, 2007, VAPHS issued Research Data Security and
Privacy Policy. The new policy specifically outlines processes for
disposition of research and clearly informs researchers that VA
research is the property of VA and that investigators cannot take what
they collect as part of VA-approved research when they leave the
institution. Additionally, local policies and procedures will continue
to be revised as needed, including policy related to tissue, specimen
and data banking.
The VA Pittsburgh Healthcare System operates a robust research
program committed to contributing to science and enhancing care to
veterans and the broader community. We have added compliance staff to
increase research oversight and leadership is continuing an ongoing,
in-depth review to ensure all VA researchers adhere to the highest
level of human subjects' protection.
This concludes my statement. I would be pleased to answer any
questions the Subcommittee may have.
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Biography for Michael E. Moreland
Michael E. Moreland was appointed Network Director of the VA
Healthcare--VISN 4, on December 24, 2006. In this position he directs
the operations, finances and clinical programs of a health care system
that serves an estimated 1.5 million veterans throughout Pennsylvania
and Delaware, as well as portions of West Virginia, New Jersey, Ohio
and New York. The system is comprised of ten medical centers and 40
community based outpatient clinics.
Prior to this appointment, Mr. Moreland had been the Director of
the three-division VA Pittsburgh Healthcare System (VAPHS) since June
18, 2000. Mr. Moreland is a Fellow of the American College of
Healthcare Executives and received the Presidential Rank Award for
Meritorious Achievement from President Bush in November 2002. He is a
member of the VHA National Leadership Board Finance Committee.
Mr. Moreland began his service with the Department of Veterans
Affairs in 1980 as a clinical social worker. He held progressively
responsible positions with several VA Medical Centers, including
serving as the Director of Butler VA Medical Center from August 1997
until his appointment to VA Pittsburgh. He was also Deputy Network
Director of VA Health Care Network 2 in Upstate New York, Associate
Director at Lebanon VA Medical Center in Pennsylvania, Chief of Social
Work Service at the Highland Drive VA Medical Center in Pittsburgh, and
held various assignments as a Clinical Social Worker in the 1980s. Mr.
Moreland received a Bachelor of Arts degree from the University of
Maryland at Baltimore in 1978 and earned his Masters degree in Social
Work from the University of Maryland in 1980.
Chairman Miller. All right. We do not have written
testimony from any of the other witnesses, but I understand
each of you wishes to give oral testimony, so why don't we just
go down the line. Dr. Sonel?
STATEMENT OF DR. ALI SONEL, ASSOCIATE CHIEF OF STAFF, RESEARCH
AND DEVELOPMENT, VA PITTSBURGH HEALTHCARE SYSTEM, DEPARTMENT OF
VETERANS AFFAIRS
Dr. Sonel. Good afternoon, Mr. Chairman, and Members of the
Subcommittee. I would like to thank you for providing this
opportunity to discuss the events surrounding the disposal of
various samples, from the now-closed Special Pathogens
Laboratory at the VA Pittsburgh Healthcare System.
I am Dr. Ali Sonel, and I am the Director of the Cardiac
Catheterization Laboratories and Associate Chief of Staff for
Research and Development at VAPHS.
To provide some context, VAPHS is home to one of the
largest research programs in the Nation with over $24 million
in annual research expenditures and 276 active research
protocols including 165 human research participant protocols
conducted by 120 investigators.
Fostering scientific research and ensuring the safety,
rights, and welfare of research participants through compliance
with local, State, and national regulatory requirements for
protection of human subjects are critical to our mission
serving America's veterans.
In September 2006 I became the ACOS for research. Prior to
this time, I was not involved with the closure of the Special
Pathogens Lab. The Special Pathogens Lab Director did not
contact me to request a transfer of any biological samples or
specimens. The only request I received for transferring any
specimens or samples was made by another member of the Special
Pathogens Lab staff in October 2006. This researcher inquired
about potentially transferring biological isolates derived from
human subjects and related environmental samples referencing an
earlier discussion with the prior ACOS for research. After
discussing this request with the Chief of Staff, I asked the
researcher to present us with any required paperwork for such a
transfer. In order to better understand the request, I also
asked our research compliance office to determine what items
specifically were being requested for transfer, their
condition, and whether or not such a transfer would be
permitted by existing regulation. However, I did not receive
any formal paperwork or materials transfer agreements. A
meeting was arranged at the end of November between the VAPHS
Education and Compliance Coordinator and Special Pathogens Lab
staff members so the Special Pathogens Lab staff could identify
and catalog the samples and specimens in question. This meeting
was scheduled for December 5, 2006.
On December 4, I sent an e-mail to the Chief of Staff to
confirm that there were no administrative barriers for this
meeting to take place. The Chief of Staff responded positively
and included ACOS for Clinical Support on the e-mail string to
confirm. The ACOS for Clinical Support indicated at 3:09 p.m.
on December 4th that the freezers containing the samples were
cleaned out and the freezers were returned. The Chief of Staff
concluded that there were no materials left for the Special
Pathogens Lab staff to review and suggested that they be
directed to the ACOS for Clinical Support if they had any
further questions regarding the samples.
At that point, I had asked the Research, Education and
Compliance Coordinator to cancel the meeting with the Special
Pathogens Lab staff and directed them to the ACOS for Clinical
Support for any further inquiries.
There were no policies specific to VAPHS as of December 4,
2006, with regard to this position of tissue or data
repositories in a situation where the investigator is no longer
authorized to conduct research. VHA Handbook 1200.5 stipulates
that if an investigator leaves a VA facility, the original
research records must be retained at the institution. VHA
Handbook 6300.1 further notes the records and information
collected and created by VA personnel in the conduct of
official business belong to the Federal Government and not to
the employees who initiated their collection or creation.
On October 19, 2007, VAPHS Research Data Security and
Privacy Policy was issued outlining local policies regarding
the security of research information. This policy, which was
written based upon guidance provided by the Office of Research
Oversight and Office of Research and Development, clearly
states that VHS research data belongs to the VA. The policy
describing our procedures relating to the disposition of
research collection states that any data to be retained,
reused, or shared for future studies must be housed in a data
repository and that the creation of the repository requires the
development of policies and procedures that must be approved by
the VAPHS IRB and the Research and Development Committee.
VAPHS is currently developing a comprehensive policy
addressing the handling and disposition of research data and
collections including situations where the investigator's
appointment was terminated or in cases where research data or
specimens were collected without proper regulatory approvals,
thus constituted serious non-compliance.
Thank you again for your time, Mr. Chairman. I am prepared
to answer any questions you may have.
[The prepared statement of Dr. Sonel follows:]
Prepared Statement of Ali Sonel
Good morning Mr. Chairman and Members of the Subcommittee. I would
like to thank you for providing this opportunity to discuss the events
surrounding the disposal of various samples from the now-closed Special
Pathogens Laboratory (SP Lab) at the VA Pittsburgh Healthcare System
(VAPHS). My name is Dr. Ali Sonel and I am the Director of the Cardiac
Catheterization Laboratories and the Associate Chief of Staff (ACOS)
for Research and Development at VAPHS.
To provide some context, VAPHS is home to one of the largest
research programs in the Nation with over $24 million in annual
research expenditures and 276 active research protocols, including 165
human research participant protocols, conducted by 120 investigators.
Fostering scientific research and ensuring the safety, rights and
welfare of research participants through compliance with local, State,
and national regulatory requirements for protection of human subjects
are critical to our mission of serving America's veterans.
In September 2006, I became the ACOS for Research. Prior to this
time I was not involved with the closure of the SP Lab. The SP Lab
Director did not contact me to request a transfer of any biological
samples or specimens. The only request I received for transferring any
specimens or samples was made by another member of the SP Lab staff in
October, 2006. This researcher inquired about potentially transferring
biological isolates derived from human subjects and related
environmental samples, referencing an earlier discussion with the prior
ACOS for Research. After discussing this request with the Chief of
Staff, I asked the researcher to present us with any required paperwork
for such a transfer. In order to better understand the request, I also
asked our Research Compliance Office to determine what items
specifically were being requested for transfer, their condition and
whether or not such a transfer would be. permitted by existing
regulations. However, I did not receive any formal paperwork or
materials transfer agreements. A meeting was arranged at the end of
November between the VAPHS Research Education and Compliance
Coordinator and SPL staff members so the SPL staff could identify and
catalog the samples and specimens in question. This meeting was
scheduled for December 5, 2006.
On December 4, I sent an e-mail to the Chief of Staff to confirm
that there were no administrative barriers for this meeting to take
place. The Chief of Staff responded positively and included the ACOS
for Clinical Support on the e-mail string to confirm. The ACOS for
Clinical Support indicated at 3:09 PM on December 4th that the freezers
containing the samples were cleaned out and the freezers were returned.
The Chief of Staff concluded that there were no materials left for SP
Lab staff to review and suggested that they be directed to the ACOS for
Clinical Support if they had any further questions. At that point, I
asked the Research Education and Compliance Coordinator to cancel the
meeting with the SPL staff and directed them to the ACOS for Clinical
Support for any further inquiries.
There were no policies specific to VAPHS as of December 4, 2006
with regard to disposition of tissue or data repositories in a
situation where the investigator is no longer authorized to conduct
research. VHA Handbook 1200.5 stipulates that if an investigator leaves
a VA facility, the original research records must be retained at the
institution. VA Handbook 6300.1 further notes, ``The records and
information collected and created by VA personnel in the conduct of
official business belong to the Federal Government and not to the
employees) who initiated their collection or creation.''
On October 19, 2007, VAPHS Research Data Security and Privacy
policy was issued, outlining local policies regarding the security of
research information. This policy, which was written based upon
guidance provided by the Office of Research Oversight and the Office of
Research and Development, clearly states that ``VHA research data
belongs to the VA.'' The policy describing our procedures related to
the disposition of research collections, states that ``any data to be
retained, reused, or shared for future studies, must be housed in a
data repository and that the creation of the repository requires the
development of policies and procedures that must be approved by the
VAPHS IRB and Research and Development Committee.''
VAPHS is currently developing a comprehensive policy addressing the
handling and disposition of research data and collections, including
situations where the investigator's appointment was terminated or in
cases where research data or specimens were collected without proper
regulatory approvals, thus constituting serious noncompliance.
Thank you again for your time, Mr. Chairman. I am prepared to
answer any questions you may have.
Biography for Ali Sonel
Dr. Ali Sonel is currently the Associate Chief of Staff for
Research and Development at the VA Pittsburgh Healthcare System as well
as the Director of Cardiac Catheterization Laboratories at the same
institution. Dr. Sonel has also has served as Chairperson of the
Institutional Review Board at the VA Pittsburgh Healthcare System from
1999-2006. Dr. Sonel has also been the Director of the ACLS and BLS
programs at the VA Pittsburgh Healthcare System since 1999. His
research interests include management of acute coronary syndromes and
disparities in health care as they relate to acute coronary syndromes.
He has been the author of numerous peer-reviewed research publications
in his field. Dr. Sonel is also a champion of promoting adherence to
evidence-based practice guidelines in cardiac care and leads many
quality improvement programs to improve delivery of care and outcomes
of veterans. Dr. Sonel is also an Assistant Professor of Medicine at
the University of Pittsburgh and Affiliate Faculty at the Center for
Health Equity Research and Promotion.
Dr. Sonel is a graduate of the Hacettepe University, School of
Medicine in Ankara, Turkey. He completed his internal medicine,
cardiology and interventional cardiology training at the Indiana
University School of Medicine in Indianapolis, Indiana. He has been at
the VA Pittsburgh Healthcare System since 1998.
Chairman Miller. Dr. Melhem? You need to turn your
microphone on.
STATEMENT OF DR. MONA MELHEM, ASSOCIATE CHIEF OF STAFF,
CLINICAL SUPPORT SERVICE LINE, VA PITTSBURGH HEALTHCARE SYSTEM
(VAPHS), DEPARTMENT OF VETERANS AFFAIRS
Dr. Melhem. Good afternoon and thank you for the
opportunity to appear before you today. My name is Dr. Mona
Melhem. I am the Associate Chief of Staff for Clinical Support
of the VA Pittsburgh Healthcare System. I am also a Professor
of Pathology at the University of Pittsburgh, School of
Medicine. I have been a practicing physician and a pathologist
at the Department of Veterans Affairs in Pittsburgh since 1986,
and I did additional clinical special qualifications. I am a
board-certified in anatomic and clinical pathology and
hematopathology, and I have published more than 150, peer-
reviewed articles and published abstracts of research presented
in national and international conferences.
For the past 22 years, I have taken on greater clinical and
administrative responsibilities within the pathology and lab
medicine services of the VA, and I began my current position as
Associate Chief of Staff and Vice President of Clinical Support
since 2001. In this capacity, I am responsible for pathology
and lab medicine including the clinical microbiology and
Special Pathogens Lab.
In January 2006, acting in my oversight capacity, I
requested a routine review of the clinical productivity and
financial expenditure of the Special Pathogens Lab. This lab
was chartered in the 1980's as the clinical resource for VA.
The lab was to be financially independent and to serve the
clinical needs of the VA Pittsburgh Healthcare System and other
VA medical centers in what was then an emerging field of
Legionella testing. Based on this review, it was clear the lab
was not productive and was a drain on clinical resource. This
led me to the decision to consolidate the Special Pathogens Lab
functions into the main clinical and microbiology labs in the
main building.
Of note, the Chief of Infectious Disease by law cannot be
also named administratively Chief of Microbiology Lab, and this
constituted a conflict of interest and self-referral of any
specimens that go to this lab.
In preparation for the lab's closing, I ordered lab
personnel to move all recognizable, cataloged and well-marked
intact tubes and specimens to the main laboratories to ensure
the patients' confidentiality and the specimens' integrity.
There were several efforts to enlist the cooperation of the
then-director of the Special Pathogens Lab but to no avail.
Upon the Special Pathogens Lab Director's departure, we
found a freezer filled with unidentified biological materials
and microorganisms. There was simply no way of knowing the
specimens' or danger to the public. Special pathogens are
infectious agents that produce serious disease in humans; and
so in July of 2006 in the interest of public safety and the
health of our veterans, we requested the Vice President of
Facility Management to coordinate the disposal of hazardous
material and immediate cleaning of the Special Pathogens Lab.
These steps were consistent with established procedures and
guidelines followed by both public and private laboratories
across the world which dictate that unknown remaining specimens
must be disposed of as soon as possible.
I was not aware of any effort by the staff of the Special
Pathogens Lab to transfer any samples to qualified labs at the
University of Pittsburgh. Some time around September '06,
roughly one month after the closure of the lab, I had an
informal conversation with the Associate Chief of Staff for
Research and Development about the specimens that were
preserved after the lab closure. I stated at that time that we
preserved specimens we knew to be part of an approved research
protocol or would otherwise be able to identify. Well-labeled,
well-cataloged specimens from other investigators were moved to
the main clinical lab under strict freezing condition to
maintain their integrity.
On December 4, I asked that personnel about the status of
the remaining sample, knowing then that it had been destroyed
and taken care of some time between July and September. Based
on my earlier instruction, I believed they had already been
properly destroyed. I was informed there may be some biohazard
material remaining in Building 2 where the Special Pathogens
Lab was located.
Since this lab had been closed since July of 2006, I
ordered an extensive cleaning and disposal process of all
remaining unidentifiable, broken, or abandoned tubes.
Mr. Chairman, that concludes my statement. I am prepared
for any questions.
[The prepared statement of Dr. Melhem follows:]
Prepared Statement of Mona Melhem
Mr. Chairman and Members of the Subcommittee on Science and Technology:
Good morning and thank you for the opportunity to appear before you
today. My name is Dr. Mona Melhem, and I have been a practicing
physician and pathologist in the Department of Veterans Affairs (VA)
Pittsburgh Healthcare System (VAPHS) since 1986. I am also a Professor
in the Department of Pathology at the University of Pittsburgh, School
of Medicine. I am a board certified Anatomic and Clinical Pathologist
with Special Qualification in Hematopathology. I have published more
than 150 articles in peer-reviewed journals and published abstracts of
research presented at both national and international conferences. For
the past 22 years, I have taken on greater clinical and administrative
responsibility within the Pathology and Lab medicine services. I began
my current position as Associate Chief of Staff and Vice President of
the Clinical Support Service line in 2001. In this capacity, I am
responsible for Pathology and Lab medicine, including the clinical,
microbiology and Special Pathogens Labs.
In January 2006, acting in my oversight capacity, I requested a
routine review of the clinical productivity and financial expenditures
of the Special Pathogens Lab. This lab was chartered in the early 1980s
as a clinical resource for VA. The lab was to be financially
independent and to serve the clinical needs of VAPHS and other VA
medical centers in what was then an emerging field. Based on this
review, it was clear the lab was not productive and was a drain on
clinical resources. This led me to the decision to consolidate the
Special Pathogens Lab's functions into the main clinical microbiology
labs in the main building.
Of Note: The Chief of Infectious Diseases, by law, cannot be also
named Chief of the Microbiology Lab as this constitutes conflict of
interest and self-referral.
In preparation for the Lab's closing, I ordered lab personnel to
move all recognizable, catalogued, and well-marked, intact tubes and
specimens to the main laboratories to ensure our patients'
confidentiality and the specimens' integrity. There were several
efforts to enlist the cooperation of the Director of the Special
Pathogens Lab, but to no avail.
Upon the Special Pathogen Director's departure, we found a freezer
filled with unidentifiable biological materials and microorganisms.
There was simply no way of knowing the ?specimens' risk or danger. Dr.
Yu's testimony attested that organisms were sent to the SP Lab from all
over the world. Special pathogens are infectious agents that produce
serious disease in humans, and so in July 2006, in the interests of
public safety and the health of our veterans, we requested the Vice
President of Facility Management coordinate the disposal of hazardous
material and the immediate cleaning of the Special Pathogens Lab. These
steps were consistent with established procedures and guidelines
followed by both public and private laboratories across the world which
dictate that unknown remaining specimens must be disposed of as soon as
possible.
I was not aware of any efforts by the staff of the Special
Pathogens Lab to transfer any samples to qualified labs at the
University of Pittsburgh. Sometime around September 2006, roughly one
month after the closure of the lab; I had an informal conversation with
the Associate Chief of Staff for Research and Development about
specimens that were preserved after the lab closure. I stated at that
time that we preserved specimens we knew to be part of an approved
research protocol or were otherwise able to identify.
On December 4, 2006, I asked lab personnel about the status of the
remaining samples. Based on my earlier instructions, I believed they
had already been properly destroyed. I was informed there maybe some
biohazardous material remaining in Building 2, where the Special
Pathogens Lab was located. Since this lab had been closed since July
2006, I ordered an extensive cleaning and disposal process of all
remaining unidentifiable, broken or abandoned tubes.
Mr. Chairman, that concludes my statement, I am prepared to answer
any questions you may have.
Biography for Mona Melhem
Dr. Mona Melhem has served as the Associate Chief of Staff for
Clinical Support Service Line, at VA Pittsburgh Healthcare System
(VAPHS) since 2001. She received her MD degree from Cairo University,
Cairo, Egypt, and completed a residency training program at the
University of Pittsburgh Medical Center in 1986. She joined the VAPHS
as a Career Development Awardee, Research and Development and staff
pathologist in 1986. She was appointed Chief of the Hematology in 1990.
She is board certified in Anatomic and Clinical Pathology and
Hematopathology and is a member of several professional and scientific
societies, including the American Association for the Advancement of
Sciences (AAAS), the American Association for Cancer Research (AACR),
the International Academy of Pathologists (IAP) and the American
College of Healthcare Executives (ACHE). She received several honors
and awards, including a clinical fellowship of the American Cancer
Society, the Young Investigator award by the American College of
Nutrition. She is well published in the medical literature with over
150 publications in refereed journals, invited articles and national
and international scientific conferences. She is a professor of
Pathology, University of Pittsburgh School of Medicine and is active in
departmental and medical school committees, as well as the local
community.
Chairman Miller. Dr. Graham.
STATEMENT OF DR. STEVEN H. GRAHAM, DIRECTOR, GERIATRIC
RESEARCH, EDUCATIONAL AND CLINICAL CENTER, VA PITTSBURGH
HEALTHCARE SYSTEM, DEPARTMENT OF VETERANS AFFAIRS
Dr. Graham. Thank you. My name is Steven Graham, and I am
the Director of the Geriatric Research, Educational, and
Clinical Center at VA Pittsburgh Healthcare System, and I am
Professor of Neurology at the University of Pittsburgh. My own
research program concerns the mechanisms of neuronal cell death
and is funded by the National Institute of Health and
Department of Veterans Affairs.
I served as Associate Chief of Staff for Research at VA
Pittsburgh Healthcare System from July 2002 until September
2006. I am prepared to discuss my involvement and knowledge of
the Special Pathogens Lab's closing and related issues.
In March 2006 I participated in a meeting with the senior
VA Pittsburgh leadership regarding the Special Pathogens Lab.
At that meeting, serious questions were raised about the lab's
lack of peer-reviewed research grants and whether approved
research was being conducted in the laboratory. There were also
questions about the extent to which the lab's activity
supported veterans' health care.
In April 2006, I met with the Special Pathogens Lab's
Director and VA Pittsburgh senior leadership to discuss these
concerns. At the meeting the lab director was asked to provide
a list of institutions and companies for whom the lab was
performing studies, the number of VA studies, and a list of all
research studies approved by the Institutional Review Board.
We asked the Lab Director to comply with the requirements
for IRB and R&D Committee review of his research program. The
VAPHS Director directed that an audit be conducted of the Lab's
accounts in the Veterans Research Foundation of Pittsburgh.
I understand that the hospital director later decided to
close the Special Pathogens Laboratory, although I did not
participate in any meetings where this was discussed.
The results of this foundation financial audit and review
of additional documents by the research service suggested the
strong likelihood that the lab had conducted research without
prior approval from an IRB or the Research and Development
Committee. The VAPHS Director and the Office of Research
Oversight, ORO, were informed of these concerns.
The VAPHS Director convened a Board of Investigation on
which I served. I referred this matter to VAPHS Research
Compliance Committee for further investigation and action.
In July 2006 I met with the Director of the hospital, Chief
of Staff, and the Research Administrator Officer regarding the
lab's closure. The concern was raised that there might be
biohazardous material in the lab that could constitute a safety
hazard. The Director asked the Research Administrative Officer
and me to address this problem. To the best of my knowledge,
the Research Administrative Officer and the Biosafety Officer
subsequently entered the laboratories and disposed of all
cultures still growing in incubators as well as biological
agents and chemicals stored in 4-degree refrigerators.
Specimens kept in the minus-70 freezers were not disposed of at
that time.
In August of 2006, I was contacted by a former Special
Pathogens Lab staff scientist and the Director of the Special
Pathogens Lab regarding the possible transfer of equipment and
reference specimens from the lab. I informed the Special
Pathogens Lab Director that equipment bought by the Veterans
Foundation of Pittsburgh remains the property of the
foundation, and regulations allow that equipment to be
transferred only to another VA or VA Foundation.
I was informed that it would be difficult or impossible to
transfer any human specimens, but it might be possible to
transfer bacterial specimens to another institution. This would
require a materials transfer agreement that must be endorsed by
the accepting institution and approved by the VAPHS
Administration. At that time, the new laboratory was not
operational, so I considered it premature to consider this
issue further. I did communicate this desire to transfer the
specimens to the Research Administrative Officer. I have no
direct knowledge of the destruction of specimens on December 4,
2006.
At the request of the Subcommittee, I have also been asked
to comment on the efforts of a schizophrenia researcher who
left VA Pittsburgh in 1995 to transfer specimens to another
institution. In 1998 and 2000, requests were submitted to my
predecessor as ACOS for Research to transfer cerebrospinal
fluid and blood specimens that were obtained under an approved
IRB protocol to another institution. The ACOS for Research
eventually denied that request upon the advice of the VA
regional counsel and the VA's Office of Research and
Development. The transfer request was not compatible with VHA
directive 2000-043 regarding Banking of Human Research
Specimens. Another investigator at VAPHS agreed to take custody
of these samples, and they remain at the hospital to this day.
This concludes my statement. I am prepared to answer any
questions the Subcommittee may have.
[The prepared statement of Dr. Graham follows:]
Prepared Statement of Steven H. Graham
Good morning, Mr. Chairman and Members of the Subcommittee and
thank you for this opportunity to discuss issues regarding the closure
of the Special Pathogens Laboratory (SP Lab) at the VA Pittsburgh
Healthcare System (VAPHS).
My name is Dr. Steven Graham and I am Director of the Geriatric
Research Educational Clinical Center at VAPHS and Professor of
Neurology at the University of Pittsburgh. I served as Associate Chief
of Staff (ACOS) for Research at VAPHS from July 2002 until September
2006. I am prepared to discuss my involvement and knowledge of the SP
Lab's closing and related issues.
In March 2006, I participated in a meeting with the senior VAPHS
leadership regarding the Lab. At that meeting, serious questions were
raised about the Lab's lack of peer-reviewed research grants and
whether approved research was being conducted in the laboratory. There
were also questions about the extent to which the Lab's activities
supported veterans' health care. In April 2006, I met with the SP Lab's
Director and VAPHS senior leadership to discuss these concerns. At the
meeting, the Lab Director was asked to provide a list of institutions
and companies for whom the lab was performing studies, the number of VA
studies, and a list of all research studies approved by the
Institutional Review Board (IRB). We asked the Lab Director to comply
with the requirements for IRB and R&D committee review of his research
program. The VAPHS Director directed that an audit be conducted of the
Lab's accounts in the Veterans Research Foundation of Pittsburgh. I
understand the VAPHS Director later decided to close the Special
Pathogens Laboratory, although I did not participate in any meetings
where this was discussed.
The results of this foundation financial audit and review of
additional documents by the Research Service suggested the strong
likelihood that the Lab had conducted research without proper approval
from an IRB or the Research and Development Committee. The VAPHS
Director, the VA Office of Research Oversight were informed of these
concerns. The VAPHS Director convened a Board of Investigation on which
I served. I referred the matter to the VAPHS Research Compliance
Committee for further investigation and action.
In July 2006, I met with the Director of VAPHS, the Chief of Staff,
and the Research Administrative Officer regarding the Lab's closure.
The concern was raised that there may be biohazardous material in the
lab that could constitute a safety hazard. The Director asked the
Research Administrative Officer and me to address this problem. To the
best of my knowledge, the Research Administrative Officer and the
Biosafety Officer subsequently entered the laboratories and disposed of
all cultures still growing in incubators, as well as biological agents
and chemicals stored in 4<SUP>+</SUP> refrigerators. Specimens kept in
the -70<SUP>+</SUP> freezers were not disposed of at that time.
In August 2006, I was contacted by the former SP lab staff
scientist and the Director of the SP Lab regarding the possible
transfer of equipment and reference specimens from the Lab. I informed
the SP Lab Director that equipment bought by the Veteran's Research
Foundation of Pittsburgh remains the property of the Foundation and
regulations allow equipment to be transferred only to another VA
medical center or VA Foundation. I informed them that it would be
difficult or impossible for any human specimens to be transferred, but
it might be possible to transfer bacterial specimens to another
institution. This would require a Materials Transfer Agreement that
must be endorsed by the accepting institution and approved by the VAPHS
administration. At that time, the new laboratory was not operational,
so I considered it premature to consider the issue further. I did
communicate this desire to transfer these specimens to the Research
Administrative officer. I have no direct knowledge of the destruction
of specimens on December 4, 2006.
At the request of the Subcommittee, I have also been asked to
comment on the efforts of a schizophrenia researcher who left VAPHS in
1995 to transfer specimens. In 1998 and 2000, requests were submitted
to my predecessor as ACOS for Research to transfer human cerebrospinal
fluid and blood specimens that were obtained under an approved IRB
protocol to another institution. The ACOS for Research denied the
request upon the advice of VA Regional Council and VA's Office of
Research and Development (R&D). The transfer request was not compatible
with VHA Directive 2000-043 regarding Banking of Human Research
Subjects Specimens. Another investigator at VAPHS agreed to take
custody of these samples and they remain at VAPHS to this date.
This concludes my statement. I am prepared to answer any questions
the Subcommittee may have.
Biography for Steven H. Graham
Steven H. Graham, MD, Ph.D., received his doctorate degrees from
the University of Texas in Houston. He then completed a neurology
residency training and postdoctoral fellowship at the University of
California San Francisco. He currently is the Director of the Geriatric
Research Education Clinical Center at VA Pittsburgh Healthcare System
and Professor and Vice Chair of Neurology at the University of
Pittsburgh School of Medicine. Dr. Graham's research concerns the
molecular mechanisms of neuronal cell death in stroke, traumatic brain
injury, and neurodegenerative diseases. His work has been continuously
funded by the Department of Veterans Affairs since 1988 and the
National Institute of Health, National Institute of Neurologic Diseases
and Stroke since 1998. Dr. Graham has received a number of awards and
honors including being elected as a Fellow of both the American Heart
Association and the American Academy of Neurology, is a member of Alpha
Omega Alpha Medical Honorary Society and has been named as the Connolly
Family Chair at the University of Pittsburgh. Dr. Graham has served on
a number of a national scientific review and advisory groups at the
National Institute of Health, Department of Veterans Affairs Medical
Research Service and American Heart Association.
Chairman Miller. Ms. Wanzie.
STATEMENT OF MS. CHERYL WANZIE, CHIEF TECHNOLOGIST, VA
PITTSBURGH HEALTHCARE SYSTEM, DEPARTMENT OF VETERANS AFFAIRS
Ms. Wanzie. Good afternoon, and thank you for the
opportunity to appear before you today. My name is Cheryl
Wanzie. I am an American Society of Clinical Pathologists,
Registered Medical Technologist since 1971. I have been
employed with the Department of Veterans Affairs since 1973.
My current position is Chief Medical Technologist,
Pathology and Laboratory Medicine at VA Pittsburgh Healthcare
System. I was responsible for overseeing the quality of the
process for clinical testing of samples from VA patients
performed by the Special Pathogens Laboratory and ensuring that
the laboratory met the standards for laboratory accreditation.
I was and am currently responsible for allocating the clinical
laboratories supply budget and monitoring associated workload
data.
In January of 2006, I provided workload and cost data for
the Special Pathogens Lab to Dr. Mona Melhem, Associate Chief
of Lab, Clinical Support Service Line. After reviewing the data
and obtaining other information, Dr. Melhem determined that the
Special Pathogens Lab's clinical and environmental testing
workload could be performed more efficiently in the clinical
microbiology laboratory. Dr. Melhem asked me to facilitate and
oversee the transition of the clinical and environmental
Legionella testing to the main laboratory. In June 2006, Dr.
Melhem informed me that the Special Pathogens Laboratory would
close in July and that the clinical microbiology laboratory
would assume both clinical and environmental Legionella
testing.
On the morning of July 19, 2006, Dr. Melhem, a VAPHS
research scientist, and I met with a staff member of the
Special Pathogens Lab----
Chairman Miller. Ms. Wanzie, can you pull the microphone
closer? Apparently, the recorder is having a hard time hearing.
Ms. Wanzie. On the morning of July 19, 2006, Dr. Melhem, a
VAPHS research scientist, and I met with a staff member of the
Special Pathogens Lab to discuss the transfer of clinical and
environmental specimens and clinical laboratory equipment from
the Special Pathogens Lab to the main laboratory. Dr. Melhem
instructed the Special Pathogens Lab staff to consolidate all
clinical and environmental specimens in a clinical refrigerator
and specimens belonging to other research scientists in a
clinical ultra-low freezer which would be moved to the main
laboratory that afternoon.
Special Pathogens Lab was also instructed to prepare an
inventory of the clinical environmental specimens which they
never provided. In the afternoon, Dr. Melhem and I supervised
the transfer of the equipment and appropriately labeled
clinical specimens from the Special Pathogens Lab to the main
laboratory. At that time, VAPHS research scientist specimens
were secured in an ultra-low freezer in the main laboratory.
The remaining specimens were left in the special pathogens lab
which closed on July 21, 2006.
In the afternoon of December 4, 2006, Dr. Melhem inquired
if there were specimens remaining in the Special Pathogens Lab.
I responded that to my knowledge they were still in the Special
Pathogens Lab. Dr. Melhem informed me that the Medical Center
Director considered this to be a concern due to the presence of
biohazardous material and directed that the refrigerators and
freezers be cleaned out by the end of the day. I assembled some
of the microbiology staff and we proceeded to remove all
improperly labeled or uncataloged specimens from the Special
Pathogens Lab using standard biohazardous waste protocols. I
cautioned the staff to take extra precautions because some of
the specimens were uncapped and in broken glass tubes. The
specimens were placed in double-biohazard bags, removed from
the building, placed in biohazard waste containers to be
removed from the facility by a contractor.
In my position as Chief Technologist, I had no knowledge of
any policies in effect on December 4, 2006, concerning the
disposition of research collections. I am now aware of a VAPHS
Research Data Security and Privacy Policy which ensures
protection of private information and the disposition of
research material.
Thank you. That concludes my statement. I am prepared to
answer any questions you may have.
[The prepared statement of Ms. Wanzie follows:]
Prepared Statement of Cheryl Wanzie
Good morning and thank you for the opportunity to appear before you
today. My name is Cheryl Wanzie. I am an American Society of Clinical
Pathologist's registered Medical Technologist since 1971. I have been
employed with the Department of Veterans Affairs since 1973. In my
current position as Chief Medical Technologist, Pathology and
Laboratory Medicine at the VA Pittsburgh Healthcare System, I was
responsible for overseeing the quality of the process for clinical
testing of samples from VA patients, performed by the Special Pathogens
Laboratory (SPL) and ensuring that the laboratory met the standards for
laboratory accreditation. I was and am currently responsible for
allocating the clinical laboratory supply budget and monitoring
associated workload data.
In January 2006, I provided workload and cost data for the SPL to
Dr. Mona Melhem, Associate Chief of Staff, Clinical Support Service
Line. After reviewing the data and obtaining other information, Dr.
Melhem determined that the SPL clinical and environmental testing
workload could be performed more efficiently in the clinical
microbiology laboratory. Dr. Melhem asked me to facilitate and oversee
the transition of the clinical and environmental Legionella testing to
the main laboratory. In June 2006, Dr. Melhem informed me that the SPL
would close in July and that the clinical microbiology laboratory would
assume both clinical and environmental Legionella testing.
On the morning of July 19, 2006, Dr. Melhem, a VAPHS research
scientist and I met with a staff member of the SPL to discuss the
transfer of clinical and environmental specimens and clinical
laboratory equipment from the SPL to the main laboratory. Dr. Melhem
instructed SPL staff to consolidate all clinical and environmental
specimens in a clinical refrigerator and specimens belonging to other
research scientists in a clinical ultralow freezer which would be moved
to the main laboratory that afternoon. SPL staff was also instructed to
prepare.an inventory of the clinical and environmental specimens, which
they never provided. In the afternoon, Dr. Melhem and I supervised the
transfer of the equipment and appropriately labeled clinical specimens
from the SPL to the main laboratory. At that time, VAPHS research
scientists specimens were secured in the ultralow freezer in the main
laboratory. The remaining specimens were left in the SPL which closed
on July 21, 2006.
In late afternoon of December 4, 2006, Dr. Melhem inquired if there
were specimens remaining in the SPL. I responded that to my knowledge
they were still in the SPL. Dr. Melhem informed me that the Medical
Center Director considered this to be a concern due to the presence of
biohazardous material and directed that the refrigerators and freezers
be cleaned out by the end of the day. I assembled some of the
Microbiology staff and we proceeded to remove all improperly labeled or
uncatalogued specimens from the SPL using standard biohazardous waste
protocols. I cautioned the staff to take extra precautions because some
of the specimens were uncapped and in broken glass tubes. The specimens
were placed in double biohazard bags, removed from the building, placed
in biohazard waste containers to be removed from the facility by a
contractor.
In my position as Chief Technologist, I had no knowledge of any
polices in effect on December 4, 2006 concerning the disposition of
research collections. I am now aware of a VAPHS Research Data Security
and Privacy Policy which ensures the protection of private information
and the disposition of research material.
Thank you, that concludes my statement, I am prepared to answer any
questions you may have.
Biography for Cheryl Wanzie
Cheryl Wanzie has worked for the VA Pittsburgh Healthcare System
since January 21, 1973. After graduating from the University of
Pittsburgh with a Bachelor's of Science in 1970, Ms. Wanzie continued
her education in the field of Medical Technology at Presbyterian-
University of Pennsylvania Medical Center in Philadelphia, PA. After
graduating in June 1971, she received certification as a Medical
Technologist by the American Society of Clinical Pathologists. After
working for a year in Philadelphia, Ms. Wanzie relocated to Portland,
Oregon in 1972 and accepted a Medical Technologist position at the VA
Medical Center. She resigned her position for family reasons and
returned to Pittsburgh in 1973. She was offered a position as a Medical
Technologist in the Transfusion Service at the VA Pittsburgh and worked
in the Blood Bank Laboratory until 1981. Ms. Wanzie transferred to the
Immunopathology Laboratory in 1981 and was promoted to Supervisor in
1988. In this capacity, she supervised three Medical Technologists and
one Medical Technician and was responsible for administrative and
clinical duties in the laboratory. During this time, she was appointed
as a Field Instructor for the Medical Technology Program at the
University of Pittsburgh's School of Health Related Professions. Ms.
Wanzie furthered her education at the School of Health Related
Professions and received a Master's of Science in 1982. Ms. Wanzie was
promoted to Chief Medical Technologist in 1990 and continues to hold
that position. In this capacity, she is responsible for the
administrative and clinical functions of Pathology and Laboratory
Medicine Program. The Program provides both clinical and anatomic
pathology laboratory services for three sites at the VA Pittsburgh
Healthcare System, five Community Based Outpatient Clinics and nine
other VA facilities in VISN 4. The Program provides laboratory services
24 hours a day, 365 days a year with a staff of 86 FTE. In 1990, Ms.
Wanzie received a bronze award for Outstanding Technical Supervisor
from the Pittsburgh Federal Executive Board's Excellent in Government
Awards. In 1999, she was nominated and received the gold award for
Outstanding Supervisor/Manager in a Technical Series.
Discussion
Chairman Miller. Thank you. I understand that all of you
have been interviewed by the Subcommittee staff. That is
correct. You can just nod your head. All of you remember? I
would assume it would be an event you would remember, and do
any of you now recall differently any event that you talked to
our staff about? Do any of you wish to correct anything that
you told our staff? Mr. Moreland?
Mr. Moreland. The only thing I would say is I don't
remember every single word that I said to the Committee staff.
So it would be very difficult to assert that today.
Chairman Miller. Well, I understand. I am not talking about
every single word, but do you remember the gist of anything
that you said differently now from what you recall saying
something to the staff that you now believe, you now recall
differently?
Mr. Moreland. Not a significant content. I don't, and
again, I am not trying to be argumentative----
Chairman Miller. Okay.
Mr. Moreland. I am just saying it was, you know, a few
weeks ago and we had----
Chairman Miller. I understand that nobody is going to
remember every word that you said.
Mr. Moreland.--extensive, long conversations.
Chairman Miller. But you know the gist of what you told our
staff. Do any of you now recall differently anything that you
told our staff. Dr. Sonel?
Dr. Sonel. I do not recall anything different.
Chairman Miller. Dr. Melhem.
Dr. Melhem. I do not.
Chairman Miller. Dr. Graham.
Dr. Graham. No.
Chairman Miller. Ms. Wanzie.
Ms. Wanzie. I do not.
Chairman Miller. Okay. All of you did not submit written
testimony in advance but all of you read verbatim from written
testimony. Obviously, it would have been helpful to this
committee to prepare for the hearing to have had that testimony
in advance, and all of you obviously made a conscious decision
not to provide written testimony.
Dr. Sonel, did anyone talk with you about whether you would
provide written testimony in advance?
Dr. Sonel. I was told that we could prepare oral statements
and that they would be our own statements.
Chairman Miller. Well, but you also read verbatim from a
written statement, isn't that correct?
Dr. Sonel. Correct.
Chairman Miller. I just saw you do it. Why did you decide
not to provide that statement in advance to the Committee which
obviously would have been our preference?
Dr. Sonel. We were working with the central office and
there was----
Chairman Miller. I am not sure if your microphone is on or
it is close enough to you.
Dr. Sonel. We were working with VA central office, and they
were assisting us in the submission process. So I relied on
them to----
Chairman Miller. Okay. Who read your written testimony?
Dr. Sonel. Ms. Lanzendorfer I believe from the VA----
Chairman Miller. Okay. Anyone else?
Dr. Sonel.--Legislative Affairs. I am not sure if it was
circulated to other people, but it was made clear that it was
to be our own statement.
Chairman Miller. Did she make any suggested changes in your
testimony?
Dr. Sonel. No material changes.
Chairman Miller. Did you talk to any other witnesses today
about your testimony?
Dr. Sonel. I shared my planned statement with them, yes.
Chairman Miller. Did you see their statements?
Dr. Sonel. I did.
Chairman Miller. All right. Dr. Melhem.
Dr. Melhem. Yes, sir.
Chairman Miller. Did you see anyone else's statements?
Dr. Melhem. I did see Mr. Moreland's.
Chairman Miller. Well, how about Dr. Sonel, Dr. Graham, Ms.
Wanzie?
Dr. Melhem. I did not read any of them.
Chairman Miller. Okay. Did you provide your written
statement to anyone else?
Dr. Melhem. I did send it to Ms. Lanzendorfer in the
central office.
Chairman Miller. All right. Mr. Moreland, who saw your
statement in advance?
Mr. Moreland. I submitted it to Congressional Affairs like
we usually do in Central Office, and they saw it and then I
know that I have read the testimony in front of the people here
on the panel so that we were aware of each other's statements.
Chairman Miller. Okay. Yes? You were about to say something
else.
Mr. Moreland. But there wasn't direction from either of us
about what to say, it was simply sharing the statements so we
could make sure what the other one was saying.
Chairman Miller. Dr. Graham.
Dr. Graham. Yes, I submitted a draft of my oral statement
as requested to the VA legal affairs. They counseled us not to
say anything about impending personnel actions because that
might violate the Privacy Act, and I actually recall that they
asked Mr. Moreland to redact some of his oral statements
because they might not be appropriate for a public statement.
Chairman Miller. All right. Ms. Wanzie.
Ms. Wanzie. I was asked to provide the oral statement in
written form to VA Central Office. I received some responses
back, some questions about my statement. I did not make any
substantive changes to my statement. I did read statements from
the rest of the panel.
The Catalog for the SPL's Collection
Chairman Miller. Ms. Wanzie, one of the people, perhaps it
was you, who dumped the vials into the biohazard bags and took
them to be incinerated, said that the vials were labeled with
or had both numbers and letters on them. Is that correct? Was
that you that said that?
Ms. Wanzie. I said that.
Chairman Miller. What?
Ms. Wanzie. Yes, I said that.
Chairman Miller. Okay. All right. Mr. Moreland, you heard
the testimony of the first panel. I assume that Dr. Snydman and
both Dr. Stout and Dr. Yu said that those letters and numbers
actually matched up to a catalog, and Ms. Stout attached a
catalog or appended a catalog to her testimony. What is the
basis for your statement that they were not cataloged?
Mr. Moreland. My basis was that I had never seen the
catalog and that despite numerous requests, it was not
provided. The VA catalog is actually VA property so if----
Chairman Miller. Did you ask Dr. Stout for a catalog?
Mr. Moreland. I did not personally.
Dr. Melhem. I did on several occasions, including in one of
the e-mails.
Chairman Miller. Okay.
Mr. Moreland. By having asked for the catalog, it was not
provided. So without the presence of a catalog, one cannot
ascertain what the numbering system means. And so by the lack
of provision, it becomes a catalog system that is not cataloged
because it wasn't provided. And I wanted to make clear, as I
was starting to say, the catalog actually is the property of
the organization. So that catalog, if it has been removed from
the VA and is in the presence of a non-VA employee and is not
provided to the organization, that is a significant concern to
me, sir, because it may have private information that was not
available to the public and should not be. And so despite
requests, it was not provided.
Chairman Miller. Dr. Moreland, did you look on her
computer?
Mr. Moreland. I did not look on her computer. It was
requested to be provided, and so it could have been e-mailed,
it could have been provided in written copy. And I will
mention, sir, that there were two other significant research
projects going on in that building. When we asked them to
provide a catalog of their samples, it was provided the same
day. We easily had the catalog, we had the samples labeled. We
were able to take those labeled catalog samples and move them
properly to the clinical laboratory. That was not possible to
do with the Special Pathogens Lab because they did not provide
the requested catalog.
The Technical Review's Biohazard Determination
Chairman Miller. All right. Mr. Moreland, you said in your
written testimony and your oral statement that there was a
technical review that found that the research specimens
presented a potential biohazard to both employees and our
veterans. Was that technical review in writing?
Mr. Moreland. I will have to defer that question to Dr.
Melham.
Dr. Melhem. Sir, my technical review was mostly concerned
with the clinical specimens, and the clinical specimens in a
clinical lab can only remain up to two weeks after testing of
the clinical specimen and----
Chairman Miller. Right, but we are not talking about----
Dr. Melhem.--and should have been destroyed at that time.
Chairman Miller. We are talking about the research
specimens. Was there a technical review that the research--I
mean, that certainly is the implication of this testimony.
Mr. Moreland. Well, again, what I would say is as Dr.
Melhem mentioned, if you have samples in a freezer and samples
that are not identified, I don't know what they are. I don't
know what they could be.
Chairman Miller. But you used the term technical review,
and that was all oral? It was around the water cooler? It
wasn't in writing? There was no scrap of paper generated as a
result of this technical review?
Mr. Moreland. That is correct. The technical review----
Chairman Miller. My time is----
Mr. Moreland. The technical review regarding whether it was
biohazard is done basically done with the clinical staff, and
they went over and looked. So there was not a technical review
in writing.
Chairman Miller. All right. My time is expired for this
round. Mr. Rohrabacher?
Mr. Rohrabacher. Thank you, Mr. Chairman, and Dr. Melhem,
you have responsibility, it says, of Clinical Support Services.
Do you have any responsibility for overseeing research?
Dr. Melhem. No, I don't.
Mr. Rohrabacher. So you would not have known any of this
information anyway, would you?
Dr. Melhem. Sir, the information I got is the specimen that
would----
Mr. Rohrabacher. You would not have known about the
research information?
Dr. Melhem. The information I had is that the specimens
that were kept in the freezer had patients' identifications
including first initial and four letters--the Social Security.
Mr. Rohrabacher. But you had no idea what type of research
that this dealt with?
Dr. Melhem. Sir, I am a researcher.
Mr. Rohrabacher. I know.
Dr. Melhem. And I have been a researcher for many years.
Mr. Rohrabacher. That is not your responsibility. That is
not your responsibility, is it?
Dr. Melhem. That is not my responsibility----
Mr. Rohrabacher. All right, so----
Dr. Melhem.--but I know a collection when I see a
collection.
Mr. Rohrabacher. You know a collection? And you spent a lot
of time in their lab trying to familiarize----
Dr. Melhem. I spent time looking through the freezers and
asked several times of the Director who is answering to me----
Mr. Rohrabacher. How much time did you spend did you spend
looking through their freezer?
Dr. Melhem. Well, I looked at the freezers, I determined
what belonged to the catalogs that we had and what did not
belong.
Mr. Rohrabacher. How much time did you spend was the
question?
Dr. Melhem. I was----
Mr. Rohrabacher. An hour?
Dr. Melhem.--in the freezer----
Mr. Rohrabacher. One hour?
Dr. Melhem.--a couple of times.
Mr. Rohrabacher. Two hours? Or are we talking about 30
minutes or 15 minutes?
Dr. Melhem. Probably a couple of times, a half-hour or an
hour each.
Mr. Rohrabacher. A couple of times or a half-an-hour. Thank
you. You know, when I was a young reporter, I worked for a news
organization that hired me to go to press conferences and
rewrite statements by politicians, rewriting their press
releases and supposedly covering the news. And I took it upon
myself to actually go out and investigate some stories on my
own. You know, I never had any appreciation from my bosses for
the public service that I was actually providing by
investigating corruption in our city because that wasn't their
job. Their job was to rewrite press releases and fill copy.
Excuse me if I don't notice the same sort of lack of
appreciation. Have any of you, and you are all doctors and
researchers and such, have any of you had the accomplishment of
finding the source of a bacteria that was causing thousands of
people or risking thousands of people to lose their lives? Have
any of you reached that plateau yet in your career or is it
that you are just looking through the refrigerators of people
who are involved with that type of activity? I said earlier
that, you know, in Washington we have to deal with a lot of
bureaucratic problems. I certainly identify today after your
testimony that we have got a bureaucratic attitude problem.
Someone didn't ask permission, and this is my area. Listen, I
have got to tell you, I can totally identify with what is going
on. I can sense the personality problems that arose when
someone didn't ask permission. You know, I will have to tell
you, Dr. Moreland, you are complaining that they have a
commercial client group. They are servicing the health needs of
certain people in the community. They have something to
complain about? They were offering a service to identify a
deadly bacteria to the community. Is that what you are
complaining about?
Mr. Moreland. Well, sir, what I would respond to that is
the VA has a very specific mission to take care of veterans.
Mr. Rohrabacher. That is right.
Mr. Moreland. And there are multiple commercial
laboratories----
Mr. Rohrabacher. Like I said----
Mr. Moreland.--that do the exact kind of testing----
Mr. Rohrabacher. Again, you are talking about the
bureaucratic lines, and you are upset that the bureaucratic
lines were stepped upon by these people. By the way, they may
well have not been--you know, they have been out of the
borders. I understand that. And I understand your job is to
make sure that this thing runs smoothly. Take a look at the
bigger picture here. What you are thinking of is a rogue
element of scientists looking in through their microscopes
without permission. The rest of us may look at it and say, hey,
my uncle was saved because of what this lady did. I will have
to tell you I think this type of bureaucratic attitude comes
with the job. I am not blaming you as individuals. You have
been given a responsibility to try to make a huge organization
and a huge budget, make it work. I understand that, and I
respect that. I think that when people have that type of
responsibility, quite often they can't see the forest for the
trees of what the purpose of all of this is. It is to save
people's lives, trying to make the world a little better and
these aren't rogues. These are people trying to do a good job,
and certainly you can reply to that and I will shut up after
that. Go right ahead, Dr. Moreland.
Mr. Moreland. No, sir, I was simply going to say it wasn't
that it upset me or it angered me, it was that it was not
appropriate use of government funds and government work. And
there are multiple private-sector groups that do the exact same
testing, and I don't think that it is my place to compete with
these private-sector companies to do referral lab services. And
so we are constituting our work to make sure that the clinical
work of the VA and our patients are taken care of. And I wish
Dr. Yu well in his private endeavor.
Fee for Service Testing Policies
Chairman Miller. Thank you. The staff report found that the
Research Foundation gave express approval in 1995 to do fee-
for-service testing for Legionella. Is that an incorrect
finding?
Mr. Moreland. It is an incorrect interpretation. And so
if----
Chairman Miller. What do you mean? What is the distinction
that you are making?
Mr. Moreland. Are you referencing the July 5th memo that
you have provided?
Chairman Miller. Yes.
Mr. Moreland. Yes. That is a discussion that went along
about doing fee-for-service work for other VA hospitals, and in
the memo, if you look, there is a term that is used that makes
that pretty clear, when it talks about the--in the third
paragraph, the last sentence, it says services provided to
other VA medical centers can be paid on an expenditure
transfer. This was about providing services to other VA
hospitals and other systems in the VA. And they were doing
that. And in fact, the VA Pittsburgh continues to provide those
kind of services to other VA hospitals who are sending their
Legionella samples to the VA Pittsburgh. And Dr. Melhem in the
clinical lab is indeed processing those. This was really about
that. And I will also mention it was 1995, and this is 2008
today and things do change on occasion.
Chairman Miller. Did you get word that the approval had
been revoked?
Mr. Moreland. The approval was internal to the VA
Pittsburgh.
Chairman Miller. I am sorry, what?
Mr. Moreland. The approval was internal to the VA
Pittsburgh, and so when there is--that approval can be changed
internal to the VA Pittsburgh.
Chairman Miller. Was it?
Mr. Moreland. Well, since I was the hospital director, I
would have made that decision. So what I was looking at----
Chairman Miller. Did you?
Mr. Moreland. Yes, I did, sir.
Chairman Miller. Did you do that in writing?
Mr. Moreland. I informed Dr. Yu and others that I was
concerned that we were taking samples from 600 companies across
the United States, some of them outside of the United States,
we were processing them and charging a fee. Those fees were not
covering the cost of what was going on, and it seemed to me to
be an inappropriate use of VA funds and VA services. And so it
was better that we not do that business.
Chairman Miller. Mr. Moreland, did you instruct anyone to
destroy the collection? You told our staff earlier you did not
recall doing that.
Mr. Moreland. My memory as I think I said to the staff is
that in July I had been very clear. I wanted any samples or
identified collections that included labeling and mapping, that
those samples should be moved in whole over to the clinical lab
and stored property, and anything left would be disposed of as
excess. And I thought that is what happened in July. And so
when Dr. Melhem went to the other two researchers and asked for
their catalog and got them, those samples were moved. Frankly,
I didn't know what had happened to the samples that were
constituted there because I assumed they either were moved as a
collection because of mapping or they were disposed of as would
have been the case with left over samples.
More on Transferring the SPL Collection
Chairman Miller. Were you aware that continuing discussions
about transferring them, transferring the sample?
Mr. Moreland. I don't recall being aware of that until
December when I----
Chairman Miller. Okay. Dr. Sonel, were you part of those
discussions?
Dr. Sonel. Yes, as I indicated in October, by e-mail Dr.
Stout contacted me, and I made some preliminary arrangements to
explore that request further. And that is why I got the
Research Compliance Office involved.
Chairman Miller. Okay. And when did you find out that the
collections had been destroyed?
Dr. Sonel. That was on December 4th in the afternoon when I
e-mailed my supervisor, our Chief of Staff, regarding the
planned meeting between the Special Pathogens Lab staff and
the----
Chairman Miller. What time of day was that?
Dr. Sonel. I believe that was around 3:09 p.m. is when I e-
mailed our Chief of Staff.
Chairman Miller. That you found out they had been
destroyed?
Dr. Sonel. Shortly after that, within a few minutes when he
responded and----
Chairman Miller. And at that point, did you have an
agreement to transfer the collection?
Dr. Sonel. No, we actually--Dr. Stout and I had
communicated on e-mail that we would require materials transfer
agreements, and I suggested to her that the recipient lab
should initiate the paperwork. But I was never presented any
paperwork for me to review to consider the transfer further,
and part of the intent of the meeting was for the Special
Pathogens Lab to provide paperwork, identify what they were
talking about, and identify what they had desired to transfer
and what condition they were in.
Chairman Miller. Do you have any idea what Dr. Melhem knew
about the discussions for the transfer of the collection?
Dr. Sonel. I actually want to clarify one thing that Dr.
Stout indicated during her testimony that is factually
inaccurate. She indicated that Dr. Melhem and I had had a
discussion about her intent to dispose of any materials or
samples, and we never had such a discussion. So the first that
I heard about the disposal was December 4th or the intent to
dispose was December 4th.
Chairman Miller. I am sorry. I don't think that your answer
actually provided an answer to the question I asked. Did you
talk to Dr. Melhem about your negotiations to transfer the
collection?
Dr. Sonel. Not during the negotiations themselves. I----
Chairman Miller. Well, when did you? Did you at another
time?
Dr. Sonel. When I first took over and we were going over
research space, I do remember Dr. Melhem showing a freezer that
was a remnant or residual of the Special Pathogens Laboratory
in one of the research areas. And at that point, I thought we
briefly discussed that potentially getting those out of there
by properly identifying those samples and specimens. That was a
verbal discussion, and I do not recall all the details of it.
But during the e-mail communication between Dr. Stout and
myself, we did not have any discussions with Dr. Melhem. At
that time, my discussions were directed toward my supervisor.
Chairman Miller. Just one second, please. Dr. Sonel, do you
remember sending an e-mail to Rajiv Jain----
Dr. Sonel. Dr. Jain is our Chief of Staff.
Chairman Miller.--on the day after the destruction of the
vials, I think Tuesday, December 5th. Next day. Next day. Do
you remember sending an e-mail?
Dr. Sonel. I do remember communicating with Dr. Jain
multiple times by e-mail during that time. I don't remember the
specific e-mail that----
Chairman Miller. Well, let me read this one to you. It is
number five in your book.
Dr. Sonel. Yes, I do have it here.
Chairman Miller. Okay. ``Dr. Jain, I appreciate your
support and clarification. I am a bit disappointed that I was
not give an opportunity to process this through the RCC.'' What
is the RCC?
Dr. Sonel. That is our Research Compliance Committee.
Chairman Miller. Okay. ``Which I feel would have been the
due process even if the end result may have been to destroy the
samples. The samples and their proposed fate to de-identify and
release was discussed in person with Dr. Melhem in end of
September. Dr. Graham denies agreeing to destruction of samples
as well. I sincerely hope we can avoid such a confusion, and I
would truly appreciate being kept in the loop if data or
specimen destruction is considered when it may be linked to
approved or non-approved research.'' Is that the e-mail that
you sent?
Dr. Sonel. Yes.
Chairman Miller. Okay. So you did not think then that the
procedures to decide to destroy the collection were
appropriate?
Dr. Sonel. Actually, I don't think that e-mail necessarily
says that. My intent in that e-mail is to indicate what the
process would have been had we discovered unauthorized
research. Now, in this case, I believe there was concern that
there was no clear knowledge of what these remaining specimens
and samples were and whether they were indeed clinical or
research. But our normal process if an investigator conducts
unauthorized research and collects a body of information or
samples or specimens without authorization or informed consent
from the subjects, then the Research Compliance Committee would
make a determination as to the fate of those data and the
samples and specimens collected in that process. And to give
you an example, there have been--if there is an instance where
no informed consent was obtained but somebody collected blood
samples from patients, for example, and stored them, then the
Research Compliance Committee would evaluate that serious non-
compliance and as part of that evaluation would then look at
what would be done with those collected samples. And in the
absence of informed consent, the usual action RCC takes in
those cases is to actually destroy the samples because the
primary determinant that the RCC considers is the subject's
intent as to what was to be done with the samples.
Chairman Miller. Dr. Sonel, you have just described this as
kind of an abstract discussion of procedures, but this chain of
e-mails all had to do with specific destruction of this set of
Legionella and other bacteria samples, didn't it?
Dr. Sonel. This was related to the collection in question
and the rest of this e-mail string, correct.
Chairman Miller. All of you saw the first panel discussion,
and you heard Dr. Yu and Dr. Stout and Dr. Snydman say that
this was a very valuable collection that had been used in many
peer-reviewed articles. Dr. Stout said, for instance, it had
been useful to her in developing the protocols for dealing with
Legionella in the water supply VA hospitals and that the
research collection was invaluable for that work. We have just
heard that this was just a bunch of broken bottles. Dr. Sonel,
do you believe the testimony given by the first panel was not
true with respect to the value and the scientific integrity of
that sample?
Dr. Sonel. I cannot comment to the actual value of the
scientific value of the collection that they are talking about,
and that is due to the fact that the protocols that we have had
at hand and the only existing protocol that was in effect at
the time that the Special Pathogens Lab was closed, did not
make any reference to retaining any collection of samples or
specimens, though a scientific protocol should describe how the
collection is going to be accumulated, what are going to be the
storage conditions----
Chairman Miller. That is an entirely----
Dr. Sonel.--and how they are going to be disposed of. So
what I am trying to say is we can review research based on the
protocol and the materials that are provided to us, and that is
what guides how they are collected and how they are stored; and
I did not have that information so I cannot tell you how
valuable that collection was because I had no way of verifying
that that, what was disposed of that we are discussing, is
actually what they indicated is.
Chairman Miller. I think what you just said is you don't
know?
Dr. Sonel. I do not know.
Chairman Miller. Okay. Did you do anything to find out?
Dr. Sonel. That was my intent when I arranged that meeting
with the Research Compliance Office and the Special Pathogens
Lab staff was to find out what the request was about, what it
entailed, what sort of samples were in question. That is
correct. I did not know what they were.
Chairman Miller. Okay. And they were destroyed before you
could in fact----
Dr. Sonel. Yes, apparently they were disposed of before we
could have that meeting or that request further.
Chairman Miller. Did Dr. Melhem consult with you at all
knowing that you were in discussions about what to do with the
samples, apparently her decision to destroy all the samples,
all of the bacteria?
Dr. Sonel. She did not. The first time Dr. Melhem directly
got into that e-mail string was that afternoon about that
meeting. So prior to that there was no discussion, and after
that, she did not discuss the disposition with me.
More on Reasons for Destroying the SPL Collection: Procedural
Flaws or Personality Conflicts?
Chairman Miller. Dr. Melhem, you heard the testimony of the
first panel. It was a first-rate collection of research samples
that represented 30 years of research, that it was cataloged,
it was stored in the appropriate manner, and now you have
testified that these were just some loose broken bottles. Was
the first panel testifying incorrectly? Did Yu testify to it
incorrectly? Did Dr. Stout? Did Dr. Snydman?
Dr. Melhem. Sir, Dr. Stout is a full-time clinical lab
employee, and as such her mission was to test clinical patient
specimens.
Chairman Miller. That is really not the question at all.
Dr. Melhem. The specimens in the freezer were, as far as I
am concerned, clinical patient specimens that were not--were to
be destroyed within two weeks after the clinical results have
been released into the computer and the patients taken care of.
Chairman Miller. You did not understand that any of the
vials in the refrigerator were for research specimens, not
clinical?
Dr. Melhem. Sir, I have asked Dr. Stout to present us with
whatever lists and maps or boxes or whatever in that freezer
and she did not comply.
Chairman Miller. Did you tell her that unless I get
something from you by December 4th I am destroying all this
stuff?
Dr. Melhem. I did not, and I don't have to because I have
asked her three times in a row between January and April or
May, and there was no answer and no reply.
Chairman Miller. Now, you mentioned earlier that that was
in one e-mail. Were they all in e-mails? Were they all in
writing?
Dr. Melhem. We had a meeting with her that also included
the Chief of Pathology and Lab Medicine and the then-Chief of
Infectious Disease.
Chairman Miller. Dr. Melhem, I think Ms. Wanzie also
verified as did Dr. Stout and Dr. Yu that this collection, the
vials, has numbers and letters on them, suggesting that there
was a catalog system in place. Do you deny that?
Dr. Melhem. I have not seen any log or any map of that----
Chairman Miller. But you saw the vials?
Dr. Melhem. They looked like patients' first letter and
four-digit of Social Security number which we use to identify
patient specimens.
Chairman Miller. You thought they were clinical specimens?
Dr. Melhem. I thought they were clinical specimens.
Chairman Miller. Did you ask anyone whether that was--did
Dr. Stout and Dr. Yu tell you that they were research
specimens?
Dr. Melhem. Dr. Stout and Dr. Yu were not cooperative in
any of these encounters with them, with their staff, with
anybody. Dr. Stout came to the lab at midnight between the 19th
of July and the 20th of July and took away boxes and boxes of
patients' care material and took them off-site with the help of
two non-VA personnel. And I have no idea what was taken away. I
have no idea what came back. This is not good faith.
Chairman Miller. Is that why you destroyed the samples?
Dr. Melhem. This was not why, I am just telling you that
they have no cooperation. I had no cooperation of any kind from
the people who are now claiming responsibility.
Chairman Miller. Dr. Melhem, I really don't need to be
persuaded that all of you all didn't get along all that well.
Dr. Melhem. I had no problem with any of them. That is not
true. That is not true.
Mr. Moreland. Sir, I would just say that in every
organization, there are certain procedures and rules that need
to be followed, and one of the responsibilities that I had as a
hospital director is that research must be done to protect
humans and it has to be done in compliance with rules and
regulations. And so that was one of the major issues that we
had, and a scientific collection must have a catalog. And if a
researcher is requested to provide that catalog, it should be
provided immediately. All the other researchers in that
building, two of them with substantial collections, immediately
provided that catalog and assisted us in the move. What I was
left with----
Chairman Miller. Well----
Mr. Moreland. What I was left with, sir----
Chairman Miller. Mr. Moreland----
Mr. Moreland.--was a collection of things that were
unidentified.
Chairman Miller.--from your testimony earlier today and
from what you have said to our staff, other than a discussion
in July, you were not part of this decision to destroy the
samples, isn't that right?
Mr. Moreland. Yeah, and my assumption was that in July,
anything that was collected and had a catalog was moved,
everything else was destroyed.
Chairman Miller. You were not part of the decision on
December 4th?
Mr. Moreland. No.
Chairman Miller. Okay. So your statement really doesn't
pertain to any question I have asked. Well, the testimony has
been quite at variance with the documents that were earlier
provided and with the staff interviews, and I thought that this
hearing today would probably be the end of our committee's
involvement and may be the end of our committee's involvement.
But it might be the end of this decision generally, this issue
generally. But perhaps not. I have no further questions, and
this hearing--I don't think that I have actually formally moved
to enter documents into the record. But without objection, it
is so ordered. And you all have written testimony in front of
you. Will you provide that to the Committee now? All five of
you? Okay. The hearing is adjourned.
[Whereupon, at 1:37 p.m., the Subcommittee was adjourned.
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