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



 
                      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
---------------------------------------------------------------------
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092104 Mail: Stop IDCC, Washington, DC 20402ï¿½090001

                  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.


                            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+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+ 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.



























































































































































































































































































































































































































































                      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.























































































































































                       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.















                     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-zoonotic-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+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.



















                   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+ refrigerators. Specimens kept in 
the -70+ 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.


                               Appendix:

                              ----------                              


                   Additional Material for the Record








































































































































































































































