Should Moreland allow the Special Pathogens Lab team finalize the results for the 15 institutions or let the cultures go unread


Victor Yu <victorlyu@gmail.com>

Wed, Jul 26, 2006 at 4:24 AM

To: "Boos, Scott (Specter)" <scott_boos@specter.senate.gov>

 

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

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