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Dear Scott (Sen
Arlen Specter)
Thanks for
listening to my arguments and Mr Moreland's arguments concerning the
remaining Legionella culture plates that are incubating and that
should be read this week. I have argued that the culture plates
should be read and the results interpreted and finalized by the
Special Pathogens Lab team, so the job can be completed. Mr Moreland
disagrees and he has the power to prevent the culture plates from
being read and he has exercised that power.
I have
summarized the arguments for both Mr Moreland and myself including
one additional point that you made At stake, are over 500 culture
plates from 15 clients (1 govermental agency, 3 hospitals, 11 water
treatment consultants) . They have been blind carbon-copied (bcc)
on this email to preserve their confidentiality.
I. My arguments for
concluding the work of the Special Pathogens Lab team for the 15
clients
A. The clients
mailed us the specimens because of our expertise that is unmatched
anywhere in the world.
The attachments
document the errors that can be made in commercial labs. We and CDC
have discussed the issue of certification of commercial labs for
Legionella work, given the unreliability of most labs. We offer to
train microbiologists from commercial labs gratis so as to improve
the number of quality labs in the US.
B. The
specimens were sent to us for protection of patients and the public.
If legionella
is identified in these specimens, interventional preventive measures
can be taken to minimize transmission. The results could also
identify the source of the pathogen in patients who contract
Legionnaires' disease.
C. The
information facilitates decision-making and is time-dependent.
That is, the
results from the culture plates incubating in the VA Special
Pathogens Lab will affect the management of water treatment
specialists, epidemiologists, infection control practitioners and
physicians. This means the current specimens are irreplaceable. For
example, for many specimens, the results will measure the efficacy
of disinfection already in practice. If these specimens are allowed
to die as would occur if Mr Moreland's decision would stand, then a
new round of testing would have to occur. The labor-intensiveness of
culturing should not be underestimated. And, interventional,
prevention, and treatment would be delayed unnecessarily.
In
summary, my argument is based on humanitarian concerns and a
physician's commitment to the common good.
II. Mr Moreland's
arguments for letting the cultures die and go unread.
A. I was given
a directive by Mr Moreland not to process any specimens from outside
the Pittsburgh VA since he had fired all 5 scientific personnel and
terminated the lab on July 7, 2006. None of the specimens
that arrived after July 7 were solicited. Our client list numbers
about 800. It was impractical to notify all clients especially
since we were given only 14 days to finish all specimens that had
arrived prior to July 7.
It should be
pointed out that decision for termination was given to me in writing
on July 5, 2006. I was advised that I had a right to appeal.
However, I was not able to file a timely appeal, because Mr Moreland
directed me to fire all of the scientific personnel the morning of
July 7, 2006 effectively denying me the right to appeal to VACO.
The reason for
the 14 day extension was that Mr Moreland forgot that our lab also
performs clinical testing for Pittsburgh in-patients and VA
physicians had ordered tests for Legionella for their pneumonia
patients. So, he was forced to grant a 14 day extension at the
insistence of the Medical Service Chief . However, during the 14
days, specimens from all over the US continued to come in. I decided to follow
my conscience. I realized that these specimens were important to the
clients and my responsibility was to these patients and the general
public.
B. The
specimens could be sent to other commercial labs.
The attachments
demonstrate how high quality and reliable information can save
lives. Note that there were 17 deaths in the Toronto outbreak, and
4 deaths in the San Antonio outbreak before our Special Pathogens
Lab correctly identified the pathogen as Legionella.
In the Toronto outbreak, the Canadian Reference Lab was in error,
and in the San Antonio outbreak, a commercial lab was unable to
culture legionella tha was actually present in the water supply.
Our clients
made the decision to send their specimens to the VA Special
Pathogens Lab. We accepted this responsibility The 5 scientific
personnel were informed that they had been fired so they
continued to work without pay. Mr Moreland than froze the funds from
my account so we could not purchase supplies. So, the technicians
pooled their monies and arranged for the replenishment of supplies
to keep the lab going. On one occasion, security guards harassed
the 5 personnel informing them the lab had been closed. When asked
why she was still working, she replied to the security guard "I am
working for the VA and its patients."
C. No harm
could come to the patients since the regular clinical microbiology
lab could easily handle the legionella work.
In a survey
conducted some years ago, fewer than 50% of College of American
Pathologists (CAP) - certified hospital labs could identify
Legionella correctly in test specimens. None of the technicians in
the regular clinical hospital laboratory had been trained in
Legionella techniques. Dr Janet Stout is the author of the
Legionella chapter in the American Society of Microbiology Manual of
Clinical Microbiology. Sue Meitzner, the lead microbiologist, is a
CDC-trained bacteriogist and has published on Legionnaires' disease.
D. The
administration would contact all those clients who submitted
specimens and inform them that the Lab had been terminated.
Our reply is
given in IC. above. The information we provide to our client
facilitates decision-making and is time-dependent. So, the culture
plates that are currently incubating are irreplaceable. An example:
On July 14, a major VA hospital submitted environmental water
specimens, because they had experienced at least one case of
hospital-acquired Legionnaires' disease. Following collection of
water specimens, they mailed the samples to Pittsburgh and initiated
disinfection. The results from our Lab showed 68% positivity for
legionella in the drinking water. This verified that the source of
the patient's infection was the water, because the Legionella
subtype in the water was identical to that in the patient. The
results also provided a baseline for the facilities engineer since
they initiated disinfection. Within days, the results were phoned
to the facilities engineer and the physicians. Precautions were
taken by the physicians to implement legionella testing in all
patients with pneumonia, and to initiate antibiotic therapy for
legionella in all pneumonia patients in whom the diagnosis was
uncertain. If I followed Mr Moreland's directive to cease, these
specimens would have never been processed. And, since the baseline
cultures would have been gone unprocessed, the engineers would never
have been able to assess the efficacy of disinfection. The
facilities management engineer has been bcc'd on this email and he
may be able to testify to the value of these results better than I.
E. The
cultures are not the property of the Special Pathogens Lab; they are
the property of the VA and Mr Moreland has decided that the
specimens should not be processed.
I respectfully
disagree. The specimens are the property of the 15 clients who have
been bcc'd.
F. Scott Boos
comments: Testimonials from the clients would be more persuasive
than comments from Victor Yu.
The
clients have been bcc'd on this email and they can testify privately
to the congressman without input from me as to whether they would
prefer to obtain the results or prefer to let the cultures die and
submit a new set of specimens to a commercial lab.
G. Dr Yu is
using the Veterans Research Foundation monies for commercial gain
and not research.
We developed
and formulated the most common media used for environmental cultures
today.
Every
Legionella diagnostic test in use today was tested in our
laboratory. Every antibiotic for Legionella that has been approved
by FDA was first evaluated in our laboratory. The 2 most
commonly-used antibiotics used in the world today were evaluated by
our lab in controlled clinical trials involving human subjects with
pneumonia, Over 200 peer-review publications on Legionella have
come from our lab. We have garnered research funds from VA Merit
Review .
One of our most
important studies was done in collaboration with the Pennsylvania
American Legion. 218 American legionnaires cooperated in a study
which found that Legionnaires' disease could theoretically be
contracted from water sources in a patients's home. A Special
Pathogens Lab collaboration with state heath departments of New
York, Pittsburgh, Maryland, and Ohio funded by EPA confirmed that
residents could, in fact, contract Legionnaires' disease from their
home drinking water.
In September
2006, the VA Inspector General will announce the development of a
plan to protect all VAMCs from Legionnaires' disease. The Pittsburgh
VA Special Pathogens Lab has been selected as the reference lab, and
the guidelines that we have developed in Pittsburgh will be the
template for the National VA plan.
H. Testing for
private facilities is not allowed in US government buildings.
Mr Moreland has
made these comments to both the congressman and the news media who
have requested why the Special Pathogens Lab is being terminated.
This is
incorrect as we have informed Mr Moreland on many occasions: We were
given a mandate by VACO in 1980. Lab space and 2 FTE were provided.
Our objective was to find the source of Legionella and to prevent
its occurrence. We succeeded.
In 1996, the
previous administration and Chief of Lab Medicine and Pathology
established the Pittsburgh VA Special Pathogens Lab as a Special
Reference Lab ( M-2, Part VI, Chapter 11, March 1994 ) under the
Guidelines for a Special
Clinical Resource Center.
In these guidelines, it is explicitly mentioned that work within the
private sector is acceptable.
I. I will add
another comment for Mr Moreland: Dr Yu has engaged in improper and
fraudulent behavior.
This has never
been an issue, but I have heard this innuendo from a number of my
colleagues in the past 2 days. Regardless of whether this charge is
true or not, the question remains : should the clients be able to
obtain the results which are so easily gotten since the specimens
have been processed and the incubation time is near.
A microbiologist only need examination of the plate to get the
results (unfortunately, Mr Moreland arranged for all our microscopes
to be removed from our lab). The issue of my integrity or lack of
it is a separate issue and should not detract from the issue under
discussion, since that discussion affects patients lives.
If Mr Moreland
has evidence that I have acted illegally or fraudulently, then I
will be punished.
One point: The
Veterans Research Foundation sends out invoices to the clients for
the the work we perform. All supplies and salaries are paid by the
VRF. Cash never touches our hands. Mr Moreland receives a
percentage of the funds that we garner. The monies remaining are
used to pay for equipment, supplies, and salaries. The lab is
self-supporting. Mr Moreland is the Chairman of the VRF.
In
summary, Mr Moreland's arguments as given above to me from
Congressman Murphy, Scott Boos (Sen Specter) and the Pittsburgh
Tribune-Review July 19, 2006 front page article are all bureaucratic
arguments that do not touch on patient care.
I have cc'd
also Mr Moreland on this email so he can ensure that Scott Boos'
assessment of Mr Moreland's position is valid. No conclusions should
be drawn until Mr Moreland has presented his side of the story.
Scott is
undecided as to how he should proceed with respect to resolving this
issue. I thank him for his help in informing VACO of our
dilemma (as well as Stan Caldwell, Andrew Fries (Congessman
Strickland) , Alan Smith (Congressman Doyle), and Ron Conley (Past
National Commander, American Legion). I now request that he give a
detailed assessment to Senator Specter as to how to resolve this
issue.
Likewise, I
suggest that Mr Moreland seek counsel from VACO Chief of Staff
Hamerschlag as to the wisdom of his actions.
Sincerely,
Victor L Yu MD
Professor of Medicine
University of Pittsburgh
VA Medical Center
Pittsburgh, PA
Telephone:
Office direct: 412-688-6643 Home: 412-343-7429
Office secretary: 412-688-6179 Cell: 412-901-7707
Office fax: 412-688-6507
Address
Infectious Disease Section (111E-U)
VA Medical Center
University Drive C
Pittsburgh, PA 15240
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