The Advisory Committee on Blood Safety and Availability met for the seventeenth time on September 5, 2002 at the Wyndham Washington Hotel, 1400 M Street, N.W., Washington, D.C., 20001 to consider how government and industry can work together to assure the availability of blood and blood products. Voting members present were Eve Slater, Assistant Secretary for Health, Mark Brecher, Chair, Larry Allen, Celso Bianco, Rajen Dalal, Richard Davey, Ronald Gilcher, Edward Gomperts, Paul Haas, Keith Hoots, Dana Kuhn, Jeanne Linden, Karen Shoos Lipton, Lola Lopes, Mark Skinner, and Jerry Winkelstein. Non-voting members present were Jay Epstein, Col Michael Fitzpatrick, Harvey Klein. Consultants to the Committee present were Christopher Healey and Allan Ross. Also present were Lawrence McMurtry, Acting Executive Secretary, Virginia Wanamaker, Carolin Commodore, Committee staff and approximately 100 members of the public.

After the roll call and reading of the conflict of interest instruction Dr. Slater welcomed the committee and thanked them for their past and future thoughtful consideration of the issues and assured them that their recommendations were taken very seriously. Following her remarks Mark Skinner told her that he was aware of the meeting she had recently had with the blood industry and asked if such a meeting would be possible with the blood products industry. Dr. Slater stated that his request was reasonable and Mr Skinner said that he would be in contact with her.

Dr. Brecher then reviewed the past recommendations of the committee that were pertinent to the current agenda. When he concluded Dana Kuhn asked to read a statement to the committee regarding reimbursement by John Walsh who was absent. Karen Lipton, who was scheduled to speak next, indicated that she wished to address reimbursement issues also. The Committee agreed that after her presentation on the Interorganizational Task Force on Domestic Disasters and Acts of Terrorism it would turn its attention to reimbursement issues. Ms. Lipton then reviewed the activities to date of the task force. After her presentation on the task force Ms Lipton then asked her associate, Theresa Wiegmann to outlined the various issues that negatively effect reimbursement and asked the committee to recommend to the Centers for Medicare Services (CMS) that its proposed payment rates for blood products and services be adjusted to reflect actual costs as opposed hospital cost which are felt to be inaccurate and out o date.

Dana Kuhn asked that Miriam O'Day be allowed to address the committee regarding the same reimbursement issues. Ms. O'Day proceeded to review the effect of the new CMS reimbursement rules and proposed a resolution for the committee on the subject. After some discussion the committee decided to address the issue of the resolution later in the morning. Mr. Kuhn agreed to draft language for the committee to consider when it returned to the subject.

The majority of the rest of the morning was devoted to reviewing the various blood monitoring schemes available both within the government and in the private sector. Ginny Wanamaker reviewed the currently operating OPHS project which receives quantitative data from 26 hospitals and 3 community blood collection sites and explained the resulting charts and graphs. Allan Williams reviewed the proposed Trans Net system and described how it would be a voluntary system eventually allowing all hospitals and blood centers to report shortages. Jim McPhearson of America's Blood Centers outlined the Stoplight system his organization uses followed by Peter Page who described the system used by the American Red Cross (ARC). Marian Sullivan then described the system developed by the National Blood Data Resource Center. That system is a statistically representative system that monitors 26 blood centers and shows that blood stocks are virtually unchanged from last year. She also provided a very informative talk on how her system with its extensive base line could forecast future blood levels with varying degrees of accuracy depending on the margins of error used. This was followed by Dan McGee a statistician from the University of Florida who is a member of the FDA Blood Products Advisory Committee.

This was followed by a presentation by Dr. McGee who gave an overview of the various monitoring programs and stated that monitoring was, in itself, not sufficient. The point, he said, was not to monitor events but to look for something unusual that occurs and to attempt to determine what caused that event to occur and see if it could be fixed. In regard to monitoring blood stocks he said that he believed in the shotgun approach. Dr. McGee said that there were several disparate monitoring systems but they all indicated that there were shortages. The conclusion he drew was that if all the systems, diverse as they were, showed shortages then there must certainly be shortages. He also said that of all the systems described there was only one that quantified its data therefore it was, in his opinion, the only good system.

The following recommendation was made regarding reimbursement:

Following discussion the motion was unanimously approved.

Following lunch the committee reconvened to finish with its examination of monitoring blood stocks. Col Michael Fitzpatrick described how the Department of Defense maintains its liquid reserves. He described the problems of frozen reserves and that an adequate liquid reserve easily distributed to areas of need was advantageous to the nation as a whole.

The committee then went on to consider the issue of how much blood was enough. It heard first from Richard Counts of the Puget Sound Blood Center who described how his center collected blood and how recruitment efforts varied depending of projected need. He stated that his center had developed a model that resulted in not having had severe shortages in four or five years. It was his opinion that shortages were not so much a medical problem, but a fairly straightforward management problem.

Gerald Sandler from Georgetown Medical Center followed with a discussion of what an adequate inventory was for any given hospital. He said the decisions should be driven by a proper utilization program and that using a proper program his hospital had not experienced a cancellation of surgery in the last 10 years. He stated that having an adequate inventory and being prepared meant that the hospital would waste some blood though outdating a certain amount of its stock.

Robert Jones from New York Blood Center was the next to speak. He described how his center went from having an abundance of blood resulting from the outpouring of donors following the events of September 11, 2002 to the severe shortages that are resulting from the vCJD donor deferrals, the first phase of which was scheduled for May 31, 2002. He closed by urging the FDA to examine its donor deferral policies against the risk of a short blood supply.

Peter Page returned to tell the committee that the ARC was averaging a two to three day inventory and that level was not sufficient to cover a catastrophic event. There was enough blood in the ARC inventory to meet 96% of its customer needs but that there was a great deal of volatility in distribution. He stated that an ideal blood inventory would be a seven day supply but there would be wastage if that level would be achieved.

Ron Gilcher of Oklahoma Blood Institute (OBI) followed and he informed the committee that enough blood means enough to handle any major crisis and that OBI had not imported blood into its system in over 21 years. He maintains a 17 day blood supply and that level was moving to a 23 day supply with the addition of frozen red cells. He said that reimbursement was a critical element of how government and industry can work together to assure the availability of blood and blood products.

Louis Katz was the last invited speaker and he described how the Mississippi Valley Regional Blood Center maintained a 10 to 12 day supply at its center and were still able to export 50% of the red blood cells it produced. He described a social contract his center has with its population and how, through education, they feel that giving blood is "the right thing to do."

The committee was interested in the experiences of the organ donation program administered by the Health Services and Resources Administration . Mary Ganikos explained how Secretary Thompson has supported the organ donation program and how the program was enhanced by using incentives. She outlined the donor recruitment program.

At the request of Dr. Slater the committee turned its attention to West Nile Virus (WNV). Tony Marfin discussed efforts of the CDC to define the risk of WNV to the population. He showed graphics that illustrated the spread of the disease in animals and humans and showed how WNV effect the various segments of the population. He closed by describing research in which the CDC was involved to further define the problem.

Jessie Goodman followed with an overview of the cases of WNV confirmed to have resulted from organ transplanted from an infected donor. He closed with a description of the efforts the FDA was taking to prevent further spread of the disease through blood donations.

The committee then heard from its public speakers. Roslyne Schulman of the American Hospital

Association called for adequate reimbursement for blood and blood products. Alan Brownstein of the American Liver Foundation called for continued vigilance on the part of the FDA and CDC in regard to transfusion transmissible infections. Susan Reardon of Ortho Clinical Diagnostics called for adequate reimbursement for blood and blood products, the addition of a representative to the committee from the CMS, the re-chartering of the committee, and the implementation of prior recommendations. Rich Vogel of the Hemophilia Federation of America called for continued safety. Jan Hamilton also of the Hemophilia Federation of America thanked the committee for addressing the threat of WNV. Dave Cavenaugh of the Committee of 10,000 called for continued monitoring of blood supplies.

The committee then entered into discussions regarding appropriate resolutions. After much discussion the following resolutions were proposed: