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Formal Response to R. James Nicholson, Secretary of
Veterans Affairs, and William F. Feeley, VA Undersecretary for Health
Operations and Management
Concerning Abrupt Termination of Pittsburgh VA Special
Pathogens Laboratory
Victor L. Yu, M.D. Former Chief, Infectious Disease
Section VA Medical Center Pittsburgh, PA
and
Janet E. Stout, Ph.D. Former Director, Pittsburgh VA
Special Pathogens Laboratory VA Medical Center, Pittsburgh, PA
In this e-mail, we summarize the claims laid forth by the Pittsburgh VA
administration in 3 formal letters and 1 email to justify the closing of the
VA Special Pathogens Lab:
1) Letter from Michael E. Moreland,
Pittsburgh VA Hospital Director, to
Congressman Michael Doyle dated July 19, 2006.
2) Letter from R. James Nicholson, Secretary of
Veterans Affairs, to Victor L. Yu dated July 21, 2006.
3) Letter from William F. Feeley, Deputy Under
Secretary for Health Operations and Management, to Congressman, Michael Doyle dated July 28, 2006.
4) Letter from Michael Moreland to Congressman
Tim Murphy in email dated July 17, 2006.
The claims in all the communications are similar and can be summarized as
follows:
“The results of this review indicated that the research funds were being
used by the Special Pathogens Laboratory to conduct neither a research
project, clinical services required by the VAPHS, or authorized work under a
Memorandum of Understanding or contract.”
Reply: All of the above alleged
points are incorrect and we will rebut them with documentation. In contrast,
please note that although the claims presented by Mr. Moreland are serious,
no documentation was provided to Secretary Nicholson, Undersecretary Feeley,
Congressman Doyle, or Congressman Murphy to verify these claims.
Moreland Claim # 1
Research Projects: “It was brought to the attention of the Director that
the Special Pathogens Laboratory received research funds, but that there was no
research currently being conducted as detected by an absence of an approved IRB proposal.”
Reply: This is untrue. Attached are the
documents showing IRB approvals (Attachment: IRB Approvals). Note the
Attachment shows that R&D approval for “Various Studies of Legionella” was
in force until December, 2006. Moreland’s contention that no research was
being conducted is refuted by over 200 articles published in the peer review
scientific literature including the most visible and prestigious journals in
the world including New England Journal of Medicine, JAMA, and Lancet, plus
chapters in over 20 medical and microbiology textbooks.
a. A proactive approach to prevention of Legionnaires’ disease. Am J
Infect Control, 2006. (Attachment:
Article)
We performed a collaborative study with the Allegheny County Health
Department and the Association of Practitioners of Infection Control which
demonstrated that the approach pioneered at the Pittsburgh VA has resulted
in a significant reduction in Legionella infections in Western Pennsylvania.
Subsequently, variations of our Guidelines have been adopted by the State of
Maryland, and the countries of France, Germany, Netherlands, Denmark, and
Taiwan.
b. Legionnaires’ disease in nursing homes. J Amer Geriatrics Soc,
2006. (Attachment: Article)
We warn public health agencies and nursing home administrators that
elderly patients can contract Legionnaires’ disease from the water supply of
the long-term care facility.
c. Legionnaires’ disease in children. Lancet Infect Dis, 2006.
(Attachment: Article)
We warn pediatricians that children can contract Legionnaires’ disease
from children’s hospitals and propose a solution.
d. VA National Collaborative Study, Infect Control Hosp Epidemiol,
2007 (in press) (Attachment:
Article).
The Special Pathogens Laboratory conducted a VA Merit Review funded
multicenter study involving VA hospitals across the U.S. The results of this
study prompted the VA Medical Inspector General Office to formulate a plan
for prevention of hospital-acquired Legionnaires’ disease for the entire VA
system. The Special Pathogens Laboratory was designated as the reference lab
for this study.
e. Legionella contracted from patient homes: Multiple Articles
In an important collaborative study with members of the American Legion,
we show that Legionella could contaminate patient homes (Attachment:
Article). In 3
subsequent articles published in JAMA 1987 (Attachment:
Article), New England Journal of Medicine 1992 (Attachment:
Article), and European Journal of Clinical Microbiology 2002 (Attachment:
Article), we show that Legionnaires’ disease can be contracted from the
home water supply.
In an Environmental Protection Agency (EPA) funded study, the Special
Pathogens Laboratory coordinated testing with health departments in four
states (New York, Maryland, Ohio and Pennsylvania). Approximately 20% of
community-acquired cases of Legionnaires' disease could be traced to
contaminated water in the patient’s home (Attachment:
Abstract).
Moreland Claim # 2
“In closing the Special Pathogens Laboratory, it should be noted there is
no clinical impact to patient care. Any necessary clinical activities are to
be transferred to the Medical Center’s Clinical Laboratory.”
“I understand that it was determined that the clinical functions of the
lab could be assumed by the VAPHS clinical laboratory, as can be the
non-clinical function of Legionella testing.”
Reply:
The Special Pathogens
Laboratory provided the following clinical services to the VA: In-house
diagnostic testing services for VA patients:
- Legionella urinary antigen testing
- Legionella antibody testing (serology)
- Legionella respiratory culture and Direct fluorescent antibody
staining - Preparation of specialty culture media to detect antibiotic
resistant bacteria in patient samples
- Test for early detection of Aspergillosis in transplant patients
- Molecular typing of bacterial pathogens (S. aureus and
Klebsiella) for infection control program
Closing of the Special Pathogens Laboratory has meant that the most
sophisticated and sensitive tests for Legionnaires’ disease are no longer
available to Pittsburgh VA patients. The above mentioned tests are now
either being done by inexperienced technicians or sent out to a reference
laboratory (none of the technicians in the regular clinical hospital
laboratory have been trained in Legionella techniques). Both of these
practices have been shown to lead to misdiagnosis or under utilization of
these tests such that cases go unrecognized. The Special Pathogens
Laboratory provided expertise in execution and interpretation of these
tests, which allowed VA physicians to appropriately treat VA patients. For
example, antibody tests for Legionella do not provide a definitive diagnosis
and the results require interpretation. This level of support to physicians
is no longer available from the Special Pathogens Laboratory and Dr. Janet
Stout – the author of the Legionella chapter in the American Society of
Microbiology Manual of Clinical Microbiology.
Environmental testing for Legionella was performed by the Special
Pathogens Laboratory for all 3 VA facilities in the Pittsburgh Healthcare
System. Only a handful of laboratories in the U.S. can perform this testing
with proficiency - the Special Pathogens Laboratory was the gold standard.
This testing today is being performed at our Pittsburgh VAMC by technicians
that have NEVER done Legionella testing and without supervision from a
knowledgeable microbiologist.
In a survey conducted by the College of
American Pathology, fewer than 50% of certified hospital labs could identify
Legionella correctly in test specimens. The lack of proficiency of
laboratories in performing these tests has caused outbreaks of Legionnaires'
disease to go unrecognized. So, while it is true that these tests have been "assumed" by the
clinical laboratory of the Pittsburgh VA, the value of the test result is questionable. When this
was pointed out to the Director, he stated "the results
may not be available as fast, and the result may not be as good, but it is a
result". Is this the quality of care our Veterans deserve?
Moreland Claim # 3
“The research funds were being used inappropriately.”
Reply:
We point out that the
Veterans Research Foundation of Pittsburgh (VRFP) receives the payments from
all work performed at the Special Pathogens Laboratory and manages all
accounts. All supplies and salaries are paid by the VRFP. Cash never touches
our hands. The monies are used to pay for equipment, supplies, and salaries.
The VRFP receives a percentage of the funds that we collect. The lab is
self-supporting as required by the Guidelines for Special Reference
Laboratories. Mr. Moreland is the Chairman of the VRFP. An audit conducted
by the Pittsburgh VA Administration failed to document any malfeasance,
corruption, or inappropriate use of funds.
Moreland Claim # 4
"I also understand that although Legionella testing was once a very
specialized test, and that the VAPHS Special Pathogens Laboratory was one of
the few laboratories that could perform this test, Legionella testing is now
available at many community laboratories.”
Reply:
Attachment - Uncovered
Outbreaks documents the errors that can be made in commercial labs. The New
York Department of Health and CDC have discussed the issue of certification
of commercial labs for Legionella work, given the unreliability of many
labs. We offer training for microbiologists from commercial labs gratis so
as to improve the number of quality labs in the U.S. Note that there were 17
deaths in the Toronto outbreak, and 4 deaths in the Antonio outbreak before
our Special Pathogens Laboratory correctly identified the pathogen as
Legionella. In the Toronto outbreak, the Canadian Reference Laboratory was
in error, and in the San Antonio outbreak, a commercial laboratory was
unable to culture Legionella that was actually present in the water supply.
Moreland Claim # 5
“The work being conducted by the Special Pathogens laboratory was for
non-VA organizations.“ [In Michael Moreland’s letter to the Congressman Mike
Doyle dated July 19, 2006] “Their current research where they are collecting
samples to test for Legionella with samples from France and Canada.” This
represents a private corporation being run out of the VA with samples from
other countries [email from Mr. Moreland to Congressman Tim Murphy dated
July 17, 2006].
Reply:
Attachment - VAMC & PHA
lists the VAMC’s and Public Health Agencies that use the services of the
Pittsburgh VA Special Pathogens Laboratory. Samples from outside the U.S.
are sent to our lab because of its international reputation. However, these
constitute <1% of all samples.
Moreland Claim # 6
“No authorized work under a Memorandum of Understanding or contract.”
Reply:
In 1980, the Special
Pathogens Laboratory was created at the Pittsburgh VAMC as mandated by VACO
during 3 major outbreaks of Legionnaires’ Disease in VAMC’s (Wadsworth VA,
Los Angeles, CA; Togus VA, Togus, ME; Pittsburgh VA, Pittsburgh, PA)
[Attachment – Mather & Kunin Letters]***
In 1996, the previous administration (Thomas Cappello, Director and
Ernest Urban, Chief of Staff), and the Chief, Laboratory Medicine and
Pathology (Gurmukh Singh) established the Pittsburgh VA Special Pathogens
Laboratory as a Special Reference Laboratory (M-2, Part VI, Chapter 11,
March 1994) under the Guidelines for a Special Clinical Resource Center. The
most important point emphasized in these guidelines were that VACO could not
provide any financial support (“seed money”) and “The criterion for success
will be financial self-sufficiency”. In fact, a proposal for advertising was
discussed for the VA Special Pathogens Laboratory. The guidelines explicitly
stated that work within the private sector was acceptable. See
Attachment
- Reference Lab guidelines).
Also in 1996, we were instructed by the Pittsburgh VA financial
officer (Ray Laughlin) that a Memorandum of Understanding or contracts were
not required and were instructed to use a fee-for-service system for billing
(Attachment
- SPL Ref. Lab Testing 1996 memos). |
