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Blood Safety Transcripts

DEPARTMENT OF HEALTH AND HUMAN SERVICES
ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY

Seventeenth Meeting

"How Can Government and Industry Work Together
to Assure the Availability of Blood and
Blood Products?"

8:14 a.m.

Thursday, September 5, 2002

Wyndham Washington Hotel
1400 M Street, N.W.
Washington, D.C. 20001

P A R T I C I P A N T S

Committee Members

Mark Brecher, M.D., Chairman

Celso Bianco, M.D.
Rajen Dalal, MBA
Richard Davey, M.D.
Ronald Gilcher, M.D.
Edward D. Gomperts, M.D.
Paul F. Haas, Ph.D.
W. Keith Hoots, M.D.
Dana Kuhn, Ph.D.
Jeanne Linden, M.D.
Karen Shoos Lipton, J.D.
Lola Lopes, Ph.D.
Mark Skinner, J.D.
John Walsh
Jerry Winkelstein, M.D.

Non-Voting Government Representatives

Jay Epstein, M.D.
Colonel G. Michael Fitzpatrick
Harvey Klein, M.D.

Consultants to the Committee

Christopher Healey, J.D.
Allan S. Ross

Captain Lawrence McMurtry

C O N T E N T S

AGENDA ITEM

Call to Order, Introduction of Members, Conflict of Interest

Welcome - Dr. Eve Slater, Assistant Secretary for Health

Blood Availability

Introduction and review of prior ACBSA recommendations - Mark Brecher, Chair

Update on the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism - Karen Lipton

Remarks by Miriam O'Day re: plasma products

Monitoring of the blood supply

HHS Monitoring - Virginia Wanamaker
Trans-net - Alan Williams
America's Blood Centers - James MacPherson

Break

National Blood Data Resource Center - Marian Sullivan
American Red Cross - Peter Page

Reimbursement resolution discussion

Forecasting - Dan McGee, Florida State University

Lunch

Strategic reserves (liquid and frozen) - Col. Michael Fitzpatrick (DOD)

How much is enough?

Puget Sound - Richard Counts
Georgetown Medical Center - S. Gerald Sandler
New York Blood Center - Robert Jones
American Red Cross - Peter Page
Oklahoma Blood Center - Ronald Gilcher
Mississippi Valley Regional Blood Center - Louis Katz

Break

Lessons from the HRSA organ donation initiatives - Mary Ganikos

Update on West Nile Virus - CDC and FDA
- Anthony A. Martin, M.D., M.P.H., CDC
- Jesse L. Goodman, M.D., M.P.H. CBER, FDA

Public Comment
- Roslyne Schulman
- Alan Brownstein
- Susan Zagame Reardon
- Rich Vogel
- Dave Cavenaugh

Discussion

Adjournment

P R O C E E D I N G S

CAPTAIN McMURTRY: I'd like to welcome everybody to the Advisory Committee on Blood Safety and Availability. We have a lot on the agenda, so let me go ahead and call the roll.

[Technical problems with sound, roll call inaudible.]

CAPTAIN McMURTRY: The Ethics Division in the Office of the General Counsel has asked that I explain the rules that apply to you as special government employees, or SGEs. If you have questions, let me know. I will seek assistance from the attorneys in the Office of the General Counsel. All the matters I'll be discussing are explained in more detail in the handout that's been distributed to you.

Pursuant to several sections of the Public Health Service Act, as amended in the U.S. Code, and various provisions of the Federal Food, Drug and Cosmetic Act, the Secretary of the U.S. Department of Health and Human Services has authority to carry out research in health fields including diseases involving blood and blood products, and for issuing and enforcing regulations concerning the collection, preparation, and distribution of blood and blood products. The Advisory Committee for Blood Safety and Availability will advise, assist, consult with, and make recommendations to the Secretary and Assistant Secretary for Health regarding these broad responsibilities.

The Chair and other members are special government employees, SGEs, appointed to perform duties on an interim basis not to exceed 130 days during any 365-day period. If any of you want it, I have the U.S. Code reference for the authority.

Confidential financial disclosure reporting requirements. All committee members appointed as SGEs are required under the Ethics in Government Act, amended by the Ethics Reform Act of 1989, to file a financial disclosure report when first appointed and annually thereafter. The information reported is used to determine the matters for which the Committee member must be disqualified under criminal conflict of interest statutes.

Criminal conflict of interest statues. SGEs are subject to a number of criminal ethics statutes. Violation of the bribery provision that I'll discuss later imposes substantial fines and/or imprisonment. A violation of any of the other U.S. Code provisions is punishable as a Class A misdemeanor and subject also to fines and imprisonment.

Willful violation of the Code elevates the commission of a felony, and the Attorney General may opt for several listed penalties. In a civil action, the government need only prove the violation by a preponderance of the evidence rather than the criminal standard requiring proof beyond a reasonable doubt.

Now, the various statutes, the first being the bribery statute, which prohibits federal employees, including SGEs, from seeking, accepting, or agreeing to receive anything of value in return for being influenced in the performance of an official act. An example would be the brown paper bag full of money in exchange for recommending that the Secretary do whatever.

There is the Anti-Representation Act, which prohibits an SGE from receiving compensation for representational services rendered by the employee or other person before HHS or another federal agency or other specified entity, such as a court or committee, in any particular matter involving a specific party, one, in which the SGE has participated personally and substantially as a government employee; or, two, which is pending in the government agency in which the SGE is serving if the SGE has served more than 60 days during the immediately preceding 365 days.

The post-employment statute imposes a lifetime ban on a former SGE from representing another person or entity to HHS or other federal agency or other specified entity, such as a court or committee, in any particular matter involved a specific party in which the former SGE participated personally and substantially while serving the government.

The financial conflict of interest statute--this is the main conflict of interest statute--prohibits an SGE from participating personally and substantially in any particular matter that would affect the financial interests of the SGE, the SGE's spouse, minor child, general partner, or organization in which an SGE serves as an officer, director, trustee, general partner, or employee, or an organization with which the SGE is negotiating or with which the SGE has an arrangement for prospective employment.

Specifically, you as an SGE cannot work on matters affecting your financial interests or those of your spouse, minor children, or organizations with which you are affiliated. An example would be owning stock in Pharmaceutical X that produces a test for viral contamination. You cannot participate in discussion or decision to partner with Company X to promote that test.

You must also disqualify from matters affecting your financial interests as a class. For example, using the same scenario, you own stock in a pharmaceutical company that produces a test for viral contamination. You cannot participate in decisions regarding testing for viral contamination. However, broad matters of national policy, such as today's agenda, that don't focus on a specific industry are not a problem.

Under the regulatory waiver issued by the Office of Government Ethics, you may participate in matters affecting your employer as a member of a class, but not in a manner that will affect the employer specifically. For example, you may recommend that a grant program be established even though the university for which you work will be eligible. But you may not participate in consideration of a specific grant application submitted by your university, for example, Harvard.

Additionally, while this exception will allow you to participate in a particular matter of general applicability that would affect the financial interests of Harvard Medical School and/or Harvard University as a member of a discrete and identifiable class of similarly situated medical schools or universities, the exemption will not protect you from violation of the criminal statute if the matter will have a specific or distinct effect on Harvard Medical School or Harvard University. This means that you can participate in generally applicable matters such as legislation, regulation, or policy that affects medical schools or universities as a class. The same rule applies with respect to other types of employers, so that if you work for a pharmaceutical, you can participate in matters affecting your employer as a member of a class. However, if you have any other interests besides employment, such as stockholding, you must disqualify from all matters even if it only affects a part of the industry sector.

On the other hand, under another regulatory exemption, if your financial interest is in publicly traded securities valued at less than $25,000, you can work on matters affecting as part of the industry sector, but, again, you have to avoid matters that will have specific effect on that company.

Compensation. You may receive compensation for speaking engagements or writing undertaken in a personal capacity. However, you may not receive compensation for speaking or writing that was undertaken as part of your official duties as a member of the committee that draws on non-public information to which you have access as a member of the committee, nor if the invitation was extended primarily because of your membership on the committee. You may receive gifts where the circumstances make it clear the gift was not offered as a result of your membership on the committee.

Misuse of position. Generally, you should not use your position to imply that the committee or the government endorses your private activities. You should not disclose non-public information to which you have access. You may state your personal opinions, but you should not imply that you are speaking for the committee unless authorized to do so.

There is an issue regarding fundraising, and you may do personal charitable fundraising but may not personally solicit funds from someone who has business before the committee.

Foreign activities. Under the Constitution of the United States, while you serve as an SGE you may not have an employment relationship--that is, receive compensation--with a foreign government. This may include foreign public universities and government-owned companies, depending on the degree of control a foreign government exercises. Under the Foreign Gifts and Decorations Act, you generally may not accept gifts from a foreign government unless the worth is less than $260.

Lobbying activities. In your official capacity or as a group, committee members are prohibited from engaging in any activity which directly or indirectly encourages or directs any person or organization to lobby one or more Members of Congress. When authorized, committee members may appear before any individual or group for the purpose of informing or educating the public about a particular policy or legislative proposal.

Committee members may communicate with Members of Congress at the request of the Members of Congress. Communication to Members of Congress initiated by committee members in their official capacity as members of the committee should be coordinated through the Office of the Assistant Secretary for Legislation.

As private citizens, committee members may express their personal views, but not the views of the committee as a whole or the opinions of the DHHS to anyone.

In doing so, committee members may state their affiliation with the committee, may factually state that the committee's official approval on a matter, to the extent that non-public information is not used, but may not take new positions and represent those views as the committee's position on the matter.

Moreover, in expressing their private views, as with all personal--that is, non-governmental-- activities, committee members are not permitted to use government computers, copiers, telephones, letterheads, staff resources, or appropriated funds. All personal activities must occur off-duty time.

And, finally, political activities. The Hatch Act prescribes the restrictions on certain political activities of federal employees. Unlike the criminal statutes and most of the other ethics rules, which are fully applicable to an SGE throughout their entire term of appointment, the Hatch Act restrictions apply only during the period of the day in which you are actually performing government business. For example, at the end of the day today, after the committee adjourns, you may attend a political fundraiser and even solicit political contributions for attendees. Once again, if you have questions on any of this, let me know and I'll get the ethics attorneys to answer it for you. Thank you.

DR. BRECHER: Okay. Thank you, Mac. We're now going to move to Dr. Eve Slater, the Assistant Secretary for Health.

DR. SLATER: Thank you, Mark. I want to thank you very much for the opportunity to make just a few very brief remarks, primarily to welcome you all to what is apparently the 17th meeting of the Advisory Committee on Blood Safety and Availability.

Last January, I had the opportunity to meet several of you in an unofficial capacity, having yet to be confirmed, but now I can actually greet you formally and welcome you on behalf of Secretary Thompson. He and I very much value your service. We want to thank you especially for the time that you commit, the advice that you give, and we certainly want to reassure you that this advice will be taken very, very seriously by our office in Health and Human Services.

The agenda is robust, Mark. Thank you very much for that, and we look forward to your discussions today.

In view of the recent event, the unfortunate event, as you know, of the possible transmission of West Nile virus by an organ donor, obviously inadvertently, and the possible relationship of that to prior transfusions to that donor, I have requested an update, the most recent information available to us, and I have requested that presentation, which has been added on at the close of your schedule today. And I'm very grateful for the individuals who will be coming to do that.

So, in short, thank you again for your service. I look forward to the discussions. I believe I'll be able to stay through lunch, barring the beeper or the phone going off, and I look forward very much to your advice and counsel. Thank you.

DR. BRECHER: Thank you very much, Dr. Slater.

MR. SKINNER: Mr. Chairman, is Dr. Slater going to entertain questions? Would that be appropriate at this point?

DR. SLATER: I'd be happy to, sure.

MR. SKINNER: Great. Thank you. Again, I'm Mark Skinner. I know recently you had the opportunity to meet with members of the plasma community of this body, and I come from the other side of the community, from the blood products community. I'm with the National Hemophilia Foundation.

For a period of time, a number of us have been very concerned about the responsiveness that this committee has received for a number of our recommendations and what I think is perceived as the lack of feedback in terms of recommendations that we've put forward. And it's been deeply troubling to us. I certainly am gratified by your comments about the Secretary's acknowledgment of the importance of the work of this committee, but at some point--and I don't know where the breakdown is--that hasn't been translated back to us in tangible terms.

I guess simply what I would ask today is if you would commit to us that you would have a similar meeting with the blood products representation on this committee that you did with the blood community to discuss our specific concerns, because we do believe it's very important that the agenda that this committee have is balanced and represent both sides of the issues, and that we can discuss them collectively going forward.

DR. SLATER: Yes, I think that's a reasonable request, Mark. I have been and will hopefully always be available to those of you at this table and the organizations that you represent. Hopefully that will be borne out over time.

I think it's fair to say this is not the only committee that has expressed--"concern" perhaps is an overstatement, but at a least a question about the feedback that occurs between the time that you make your advice and the responsiveness of our offices. And I take that concern very seriously and hopefully in this capacity now will do my best with the help of Dr. McMurtry and others in this particular committee's case to provide you with a closed loop in terms of feedback that you deserve. So I accept your comment, and I can't speak for the past but hopefully we'll take the advice of the 17th meeting to heart and get back to you on it.

MR. SKINNER: Thank you. We'll look forward to meeting with you.

DR. BRECHER: Thank you, Eve.

We're going to work very hard to stay on time today, if possible, and so we're going to just move on to the next presentation. Actually, Mark, that is a good lead-in because I am going to look back on what were some of our past recommendations that came out of this committee and actually circulated to the members of the committee a summary of all the past recommendations. And if you did not receive that by e-mail--and I'll get a copy to Dr. Slater as well. But if you have not received a copy, let Mac know and we'll get you a copy.

Pertinent to this particular meeting, which deals with how can government and industry work together to assure the availability of blood and blood products, I've summarized those recommendations that I think are pertinent to this subject. In many ways, this meeting is a continuation of the discussion that was started in our last meeting about seven months ago. We were dealing with the 9/11 crisis and the blood supply. So if we can have the slide projector on--sorry, the computer projector. I'm sorry. The computer.

[Pause.]

DR. BRECHER: Okay. In the last meeting, the Advisory Committee endorsed the principles that were articulated by the American Association of Blood Banks Interorganizational Task Force on Domestic Disasters and Acts of Terrorism, which are: one, that the actual medical need for blood should drive all subsequent decisions an actions in responding to the acts of terrorism; the blood community should avoid creating supply in excess of medical need at the local blood centers; the blood community response to domestic disasters and acts of terrorism should be effectively coordinated with all stakeholders.

Next slide?

The blood community should establish clearly defined lines of communication to facilitate the response to domestic disasters and acts of terrorism, transportation mechanisms for blood units, test sample supplies and reagents including alternate and redundant capability should be identified and communicated to the blood community, and preparation for future disasters.

There should be a plan to assess the collection, processing, and testing, supply needs of blood facilities, and a plan to reintegrate with communication channels identified in the blood disaster plans, and revisions, interim or permanent, to existing regulatory requirements relating to donor suitability, collection, testing, and release of supplies and/or reagents should be based solely on actual medical need. Consistent with those principles, the Advisory Committee recommended:

A, mindful of the needs of all stakeholders, DHHS should act to promote and coordinate a single consistent public message on blood issues, and the ultimate spokesperson for the blood community should be the Assistant Secretary for Health or his or her designee;

B, emergency support functions, health and medical services, an annex of the federal response plan should be reviewed to incorporate the recommendations and organizational members of AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism;

C, that Task Force on Domestic Disasters and Acts of Terrorism should coordinate the national response of the blood community;

D, DHHS should fund the evaluation and potential development of blood reserves in parallel with supporting the development of ongoing programs for monitoring blood availability and shortages, including related reagents and supplies. And many of these topics we will get updates on at this particular meeting.

In addition, the committee recommends that DHHS identify blood donors as a critical national resource and promote blood donations in national service to maintain enough blood on the shelf to permit rational management of routine needs and disaster responses. It should be a national goal to recognize and promote self-identification of lifetime-committed donors willing to donate regularly, at least once a year, and as needed.

The committee recommends that the Secretary recognize and incorporate the FDA Office of Blood Research and Review's strategic plan into the DHHS Response Plan for Counterterrorism and Disaster Preparedness.

Next?

Going back to the August 2001 meeting, the Advisory Committee supported the proposals before it to monitor supply and demand of blood products, plasma derivatives, and their recombinant analogs, and recommends that there be adequate infrastructure, expert advice, and long-term funding for these initiatives.

Two, the President of the United States should join with other leaders of government and industry to make blood donations a national priority, including the creation of a national events coordinator with the private sector to encourage donation and to support efforts by commercial as well as nonprofit organizations that have successfully promoted blood donation.

Three, the Secretary be encouraged to move the blood demand, the sentinel monitoring program for it as quickly as possible and that the funding and the number of sites monitored be appropriate for its needs.

Next slide?

The April meeting from 2001, whereas patient access to a safe and available blood supply is a public health priority, the Advisory Committee recommended to the Secretary and to Congress that:

A, ensure that an appropriate office within the department has the responsibility to facilitate the gathering and dissemination of national blood collection, distribution, and utilization data, and development of analytical models to predict shortages. Moreover, adequate federal dollars should be provided to support collection, analysis, and distribution of these critical public health data.

Specifically, the following actions should be addressed:

one, assign responsibility for this activity; two, support programs to develop the data and ensure that data collected are available to the public; three, encourage collaboration of blood collection centers for the purpose of identifying and addressing areas of short supply of blood and blood products; and, four, encourage collaboration of plasma manufacturers for the purpose of identifying and addressing areas of short supply of plasma products and their recombinant analogs. B, support a program of public and physician education designed to improve blood and blood product donation and utilization throughout the U.S. and encourage support for such programs through the Department of Health and Human Services.

And, finally, the August '98 meeting, the Advisory Committee directed its staff to develop options to present to the Blood Safety Director for the creation of a sentinel system to monitor production, demand, and utilization of blood products and to create projections for future demand. The Advisory Committee also urged the Secretary to convene a meeting of manufacturers of plasma derivatives and their recombinant analogs to discuss strategy for distribution in light of shortages.

Now, there were several other recommendations that were made in regard to reimbursement, and I did not summarize them all here. We will hear some discussion about reimbursement today. Although it was not specifically indicated on the agenda, we will have a few minutes to discuss reimbursement. Hopefully I'd like to take the committee to the whole question of reimbursement at a later meeting for blood products.

Okay. So that concludes the prior recommendations. The next speaker is Karen Lipton from the AABB. She's going to be talking about the Interorganizational Task Force on Domestic Disasters and Acts of Terrorism. And, Karen, if you could also take a few minutes to talk about reimbursement.

Do you have a question?

DR. KUHN: Mr. Chairman, in consideration of our robust agenda that we have today, Mr. John Walsh had asked me as a committee member if we could take a portion of time today--I know it's very pressed, but there is a very important issue that has come up. It is a ruling that has arisen that will have an impact on the availability of product, access to care for plasma users needing life-sustaining therapies. And, you know, I would appreciate it if we could have an opportunity to just address that. We have a recommendation that we would like to bring to the committee which we believe would be possible for the committee to act upon, because this is an issue which, if we waited until another meeting, it will already have been enacted, and it could have great impact upon these communities.

DR. BRECHER: I don't think that that will be a problem. I think after Karen says a few words about reimbursement that she wants to say, then it would be logical to move on to that statement.

DR. KUHN: Thank you.

MS. LIPTON: Thank you. That's just what I was going to say, that we would like to address briefly the reimbursement issue because of its pressing nature.

I will be brief. A very nice set-up for me. Thank you. Thank you, Mark. I also wanted to say that, contrary to popular belief, I am not Don Doddridge, who's the chairman of the task force, but he's asked me to give the committee a little update on where we are.

I'm briefly going to go through, if I can have the next slide, the background about the task force. You've heard it all before, but just to make sure we're all up at the same place, I'll go through it briefly.

I'm going to briefly overview the plan, the response plan that the blood organizations and the rest of the organizations who are participating put together to describe how the task force and the blood community intends to respond and coordinate efforts in a disaster, talk a little bit about the Operations Handbook which we are in the process of putting together and we invite your input into, and, finally, next steps for our task force.

If I could have the next slide, please? Again, the blood organizations are what we would call our first-tier participants in this task force. It's AABB, America's Blood Centers, Red Cross, and Blood Centers of America. We also have a number of government departments and agencies who have been very active participants, and we very much appreciate the time and effort they've put into making this plan a reality. That's DOD, of course, HHS, the Centers for Disease Control, and FDA.

We also have a number of other participants who are involved in this, including AdvaMed, American Hospital Association, PPTA, American Association of Tissue Banks, and at the request of Mr. Skinner, who had asked that we put someone on from the consumer groups, we had difficulty identifying one, so we have identified a public ethicist who we have placed onto the Disaster Task Force with the responsibility of saying you represent consumer interests on this and trying to make him very aware. He undoubtedly will be in touch with a number of groups trying to make sure that he understands their concerns.

Next slide, please?

Again, our mission of the task force was to identify components of an effective, comprehensive national blood disaster plan, to identify opportunities for better coordination, particularly among the blood community participants, and then something that we added as we became more familiar with what was going on, and that's opportunities to integrate the blood disaster plan with other disaster plans in the community and also with disaster plans that are evolving in hospitals themselves, to make sure that we're not standing on one side of the issue but that we are seen as a piece of an overall comprehensive disaster response plan.

Next slide, please?

There are three overarching lessons.

Actually, the first two were the two that we articulated at the last meeting. One was the need to control collections in excess of actual need.

We believe this is very important from a public accountability standpoint and also simply from a logistics standpoint, which creates real problems if we actually end up collecting in excess of what we can use.

We also said that another lesson was the need to ensure facilities maintain inventories to prepare for disasters. We talked about a seven-day supply. I know there's going to be a discussion about that later today, and we welcome that input.

I think the most important thing that we all learned was that it was the blood on the shelves that day during the disaster that allowed us to respond. It isn't really what we collect in the days following.

Finally, in all of our discussions we recognized this as the third lesson that became more apparent as we worked with the task force, and that is the need for an overall inventory management within the United States. Again, we're going to hear something more about that in terms of blood reserves, but we do think that we need to have a better handle with real data on inventory that's available across the country, because in this time of persistent, what I call chronic and regional shortages, we need to understand where blood is and how quickly we can move it to other locations.

Since January of '02, which was the last time you heard from us, these have been our activities. We actually ran a 2002 Winter Olympics pilot test, which the Winter Olympics gave us an opportunity to find out how we could respond. It was an interesting exercise. We did learn some things. We also have requested a change to the FEMA Emergency Support Function No. 8 language. We put in an official request that went both to FEMA and to Dr. Jerome Hauer's office.

We did some work in smallpox, actually recognizing with the smallpox issue it wasn't so much a matter of having blood available but how smallpox and epidemics like smallpox might affect donor eligibility and suitability. So we have a task force that's working specifically on that.

And, finally, we did create the first draft of an Operations Handbook.

Next slide, please?

Now, here's an overview of the response plan that I just wanted to go through with you. It all starts, as we said, with an event. And once that event occurs, we have said that we would have a blood collector--we call him an affected blood collector. Now, an affected blood collector is any blood collector that provides blood in the affected area. So it's not necessarily the primary blood center there. It can even be a peripheral blood center providing blood, and that's, in fact, what happened in Salt Lake City when we really had Red Cross being the primary supplier, but we did have a blood center in Denver, Bonfice (ph), who was also a supplemental supplier.

So what we've said is that an affected blood center is responsible for a number of things. They are responsible for gathering information from their hospital customers on the nature of the emergency, current and expected hospital admissions, the potential effects of the event on the local donor base--that is, if it's a biological event, what effect do we think it will have on donors who can donate.

We've asked them specifically to assess local Type O red blood cell inventory levels and total Type O red blood cell units needed from the task force using a specific formula that we arrived at, which I won't go into.

Again, an affected blood collector is a blood center. It also includes hospitals that collect allogeneic units. We're not as interested as much in autologous, but we have a number of hospital facilities that actually collect the major portion of their share in a local community.

After that happens, the affected blood center is responsible for contacting AABB, and we actually have an 800 number. We have a national blood exchange that operates on a beeper system 24 hours a day, and so they are accessible. And they are responsible for contacting the AABB within one hour of the event and reporting what they know about the medical need and the local blood inventories.

We have a hierarchy of communication so that people understand that they're first to try land lines. Then they have a set of cell phone lines. We have amateur radio, ham radio support systems set up, and we also wireless e-mail BlackBerry. At the AABB, we actually have redundancies built into each of those capabilities.

We were finally successful--we learned this summer that we also had to contact our power supply company because when we lost our power several times, we weren't considered to be a first-tier responder. We are now a first-tier responder, and PEPCO understands that they have to get us up as quickly as they might a hospital or other organization.

Again, once we've made the contact, we then contact what we call our Level 1 First Responder Task Force members. That's America's Blood Centers, Blood Centers of America, Red Cross, AABB, FDA, and then HHS. And we are to--what we do is organize a conference call to occur generally within one hour of the event, and we first find out what kind of information we have.

At that point, the Level 1 representatives are responsible for determining the national strategy and coordinating efforts specifically about a message to the blood community and donors--that is, Do we need blood? Do we not need blood?

We're responsible for coordinating transportation and blood shipped to the affected blood center, and then talking about next steps.

Immediately after that, we go to what we call our Level 2 task force representatives. Those are the people who are not primarily involved but really do assist us in this message, and hopefully at this point we have developed a recommendation to Assistant Secretary for Health in HHS about a unified message that we would like communicated to the blood community.

Now, it doesn't mean that the blood centers won't be communicating that message to their blood donors as they're coming in the door because that will happen. But from a national perspective, we feel it's very important to have a single coordinated message out to the nation.

Can I have the next slide?

The Operations Handbook, I won't go through this a lot. I just want you to see we have, of course, our introduction, preparation, what a blood center needs to do to prepare for a disaster, and there are a number of steps included--making sure that you have a relationship with a local ham radio operator, making sure that you understand within your organization who's responsible for responding to the disaster. We have what we call the activation, that is, a step-by-step response, including transportation, vendor management, regulatory concerns, managing donors, managing crowds around the blood center, coordinating a common message and working with the media.

Section 4 is education and training. We are actually trying to develop staff instruction materials, training exercises, and regional and national drills. This is not drafted as of this point, and so if anyone has any ideas or materials that they would like to contribute to this effort, the task force would be most grateful to have some input.

Our quick reference materials are just reference materials that can be pulled out of the handbook. We also have now tried to create a hospital supplement because hospitals really are not the first-tier responders from the blood organization level. They are first tier on other levels. But we're going to create a separate booklet for the hospitals that focuses on their role as opposed to the blood center role. And, finally, we are creating a biological event supplement that will focus more on the effect on donors and the donor population than on responding to critical patient needs. Next steps is to finalize and distribute the Operations Handbook. It actually is posted on the AABB website for comments to all of our members. For those of you who would like to--Theresa, do you happen to know where it's located on there? I think it's under the disaster icon, if you go on to the public section.

MS. WIEGMANN: I need to check. I think we moved it into--it's going to be moved into the "What's New" section so that it's not just in disasters, so that it will be available. Right now it's available to our members. But we're going to be moving it to a broader page. Right now it's under our "Members" section of "What's New."

MS. LIPTON: We did send a letter, all three organizations, Red Cross--all four organizations: Red Cross, AABB, Blood Centers of America, and--let's see. Blood Centers of America, ABC, AABB, and Red Cross. We sent letters out to all of our members notifying them that we were undertaking this activity and inviting their comment and directing them to the website so that they could take a look at the materials.

Next is also going to conduct regional and national drills. As we said, we had what we called a pilot test in the Olympics. What we really need to do is have a drill where there's an event that is precipitated from the outside rather than all knowing what's going to happen. We really have to see how we could respond.

We are continuing to monitor blood-related disaster issues, for example, the whole smallpox discussion. And, actually, one of the last things I wanted to mention is the possibility of using the task force as a means of communicating about other emergency issues. I do want to mention that this weekend, as the West Nile virus issue really began to be an emergent issue, we did have a phone call from the FDA on Sunday, and we were able to convene the task force within an hour of that phone call to talk about the issues and communicate. And I just want to give a special thank you to the FDA, who I think in this whole West Nile issue has been remarkably responsive to the blood community, very open. It's been extremely helpful, and I hope to see this as a model of future communication, and our task force I think would be delighted to be a convener of all parties if that should happen again.

Any questions?

DR. BRECHER: Jay?

DR. EPSTEIN: I thank you for the kind words, Karen, and we correspondingly recognize the very helpful role that AABB has played in coordinating communications as well as providing some good thinking.

Just two brief questions. Clearly, a lot has been accomplished in the Interorganizational Task Force. Of course, the proof is always in the pudding. And I would ask if you could comment on two points.

First, what in your opinion is the strength of the organizational commitments to a common message? I think one of the biggest problems that we actually had in the wake of September 11 was disparate voices, each organizational entity seeking to do the right thing in its own view, but not necessarily coordinating. And I think part of the crux of the matter is whether there's an overarching commitment now to that principle of a joint communication to the public. So that's point one.

And then, secondly, I'd like to ask: Is there any leadership structure to the Level 1 task force? What exactly will you do in a crisis if you don't happen to have consensus? You know, the alternative to consensus within an organization is, well, you have a hierarchy and, you know, there is some element of following the leader. But, you know, this is a coalition. So how have you approached the problem of decisionmaking? There's the notion that you'll have a plan within an hour, but, you know, what if the debate's not over in an hour?

MS. LIPTON: Let me respond to the first question about the common message. I do think we had an opportunity earlier this summer to test that commitment to a unified message, and at that time we were approached by the Red Cross who was considering going out on a national appeal. And we were able to work together as the blood organizations. I don't think all of us had a single view, but we talked it over and I think we came up with, yes, we think this is important and we were very supportive and we did come out with a common message.

I will say, with all apologies to Dr. Slater, that I think there was a misstep in that we did not include HHS in this. We weren't thinking disaster mode, I think at that point. We were really thinking this is a shortage issue. But I think after speaking with Dr. Slater, we realized the strength of including HHS in this message, too, so that it's truly coordinated.

But I think after that experience I think we had a remarkably good experience working together. I think I can say--I mean, I can't speak for them, but I absolutely believe that Red Cross and America's Blood Centers and Blood Centers of America are firmly committed to making this work.

With respect to the leadership issue and, you know, who's the first among equals, I don't know the answer to that question. We really see our role as being one of the convener. I think in some ways what I would say is that what needs to drive the issue is the medical need at the site of the disaster. And I think when we get together, we will all recognize that that's the most important thing we can do, is to worry about the patients and whether we're doing the right thing, and then worry about the public and the donors.

So although I believe there will be disagreements, I think in the first instance the decision that we're making in the first hour is:

Do they need blood at the site? Do we need to convene shipments to the site? And that's going to have to be dictated by what we hear from the point of disaster, not by what we believe sitting in Washington, D.C., or Bethesda.

DR. BRECHER: Okay. Thank you. Karen, do you want to take a few minutes to talk about reimbursement?

MS. LIPTON: Yes. Theresa, could I just ask you to focus on--I'm going to ask Theresa to talk a little bit about the reimbursement issue. It will take about three minutes. Oh, five?

[Laughter.]

MS. WIEGMANN: We just wanted to raise an issue that we have discussed with the committee before, the issue of the importance of fair Medicare reimbursement for blood products and services.

Recently, the Centers for Medicare & Medicaid Services released a proposed rule establishing new payments or proposing new payments for outpatient services, including blood products and services, that would go into effect in fiscal year 2002. And we are quite concerned about these proposed payment rates.

For the first time, the agency is looking at hospital charge data rather than actual cost data that go along with these products and services. And to give you one example of how dire we think the proposed payment rates are, CMS has proposed almost a 40 percent reduction in payment per unit of leukoreduced red blood cells; that is, where today it pays approximately $137 for one unit of this product, in fiscal year 2002, if this proposed rule were to go forward, they'd pay $82.69.

Obviously this is of great concern to blood centers as well as hospitals across the country because they can't afford to absorb these losses themselves. Therefore, the AABB is working with the Red Cross, America's Blood Centers, and others in the blood community to work with CMS to try to correct this problem prior to final implementation of the rule in October.

However, you never know how those discussions are going to go, and, therefore, we'd strongly urge the Advisory Committee to weigh in on this critical patient care issue and recommend to CMS that its proposed payment rates for blood products and services be adjusted to reflect their actual costs to our community as opposed to the hospital charges, which, unfortunately, we think that the hospital charge data they're using is both inaccurate and out of date, and that leads to some significant problems for our community.

DR. BRECHER: Okay. Thank you.

Dana, I think that's a good lead-in--we have one more question. I'm sorry.

DR. WINKELSTEIN: I wondered, is there data on how much the reduction would be for plasma products such as IV gamma globulin?

DR. BRECHER: Well, I think Dana is going to be addressing some of that.

DR. KUHN: Yes, there is, and it was published on what--for example, I know for the hemophilia community they're now categorizing the reimbursement rate for hemophilia at 52 cents a unit, which is a 45 percent reduction off of AWP. These are very serious times in which this could set up a precedent for the private payer to follow suit, which would then encompass an all-impacting effect upon not only reimbursement but also upon availability. And I think that's why it comes before this committee.

If I can ask the Chair, I think that there is one other--since John Walsh wanted to present this, if someone could present it in his stead for just five minutes to explain how it would impact the plasma user community, I would like to request that the Chair allow Miriam O'Day to have the podium just for five minutes to explain how this would be, and then hopefully we can go from there into a recommendation that Mr. Walsh and myself have been working on.

DR. BRECHER: Okay, five minutes.

MS. O'DAY: Good morning. Thank you very much for allowing us some time to make some comments. We also are very concerned about the proposed rule that came out on August the 9th and the impact on availability. And for us, it means that the hospitals will be reimbursed at 45 percent below the acquisition cost, and overall it is a cut in benefits for patients receiving alpha-1 of over 50 percent, about $27,000 annually. And we're requesting that the Advisory Committee take action in the form of a resolution and that the resolution reimburse it at an appropriate level, and that in the absence of data that the payment policy be modeled on other sites of service, such as the physician's office or other non-inpatient settings.

Our rationale is as follows: that protein replacement therapy is life-sustaining and that the policy right now has serious deleterious health consequences to patients; that for alpha-1 it's the sole therapy; that a patient requires 5,000 milligrams weekly throughout their lifetime to maintain their lung function; and in the absence of data, bad decisions are being made. Hospital claims data can never adequately represent the needs of the rare disease community, and most plasma consumers fall into the rare disease category.

Lacking good prospective data, reimbursement should be based on a reasonable cost system or, as has been recommended by AABB--and we would support that--on hospital charge data.

Alpha-1 patients receiving treatment in a hospital outpatient setting do so at the recommendation of their health care providers. Many times they don't have an option of receiving their treatment at another site of service. So it's been suggested that what may happen with this policy is a cut in hospitals will cause a migration to physician offices, and, in fact, for a good number of cases, that's not possible.

And alpha-1, the treatment for alpha-1, is one of the three drugs that falls into CMS' own definition, the criteria that they set for orphan disease status. And even that special acknowledgment does not allow us adequate reimbursement. And our future recommendations include offering to work with CMS to gain a good understanding of the true cost of this illness and the impact of policy changes on this patient community.

I really would like to conclude by saying thank you so much for letting us make a statement, but also that if reimbursement is not at an adequate level, basically we feel the Federal Government is saying that these patients have no access to this treatment, that it's just not available for them.

DR. BRECHER: Okay. Thank you. Keith?

DR. HOOTS: Just one more comment. If this were implemented, in certain facets of the plasma and recombinant community it would force cost loss back on distributors, like even federally funded hemophilia treatment centers, that would make it impossible for them to continue to be a provider.

But since they are in many cases representative of state programs, it would probably force the collapse of state programs as well. So it would essentially involve--because Medicaid rules tend to follow Medicare rules. So essentially the domino effect would be that federal mandate would force the collapse of state-supported programs.

MR. HEALEY: Mr. Chairman, if I could just make a comment, as I mentioned to you, I'd be happy to yield some of my time this morning for this important topic. There's no doubt in my mind that this is the most important topic facing all the users of plasma therapies and potentially blood product recipients as well.

It's clear, to Dr. Winkelstein's point, that IVIg is similarly abused in this proposed rule, and that if changes aren't made, patients are going to suffer. I think as Ms. O'Day pointed out, it's clear that the rule is so flawed that the data are unreliable, that there's no solution but to seek an alternate payment means, and that is linking payment to these life-saving therapies to an inpatient setting. And I can tell you based on the strong recommendations of the committee in the past and how useful they've been in working to assure patient access to therapies, a recommendation from this committee that plasma protein therapies and recombinant analog therapies be reimbursed according to an inpatient fee schedule would go a long way to helping make sure that patients have continued access.

So if I could put that out on the table, I'd appreciate it.

DR. BRECHER: All right. Thank you, Chris.

I think that clearly one of the resolutions that will be coming out of this meeting at the end of the day will address the reimbursement for both plasma products as well as whole blood-derived products. And so, Dana, I think what I'd like to do is just ask you to hold on your resolution until we get to our discussion period. We will address it, I guarantee you.

DR. KUHN: And I'll make sure that we write it out and be able to distribute that ahead of time so that we can make use of our time.

DR. BRECHER: All right. We're already running a little behind, so I'd like to move on to the next item on the agenda, which is monitoring of the blood supply. We're going to go through several different strategies for assessing the adequacy of the daily supply.

We're going to begin with the HHS monitoring. Virginia Wanamaker will give the first presentation. Thanks.

MS. WANAMAKER: Good morning. I know you've heard of this project before, but I thought it's been a while so I'd just give a real quick review, and you do have handouts.

This is comprehensive daily data collected on blood and platelets from 29 sentinel sites. There's actually a list of the sites, if you want to review them, on the next to the last page of your handout. We now are set up and have been since about November for the sites to enter their data daily online, and the last copy of your handout is the actual data entry page.

This project has 29 sites--26 hospitals and three community blood sites. The community sites are centralized transfusion services that actually cross-match and provide the blood for 38 hospitals. So all together there are 64 hospitals.

The sites are geographically dispersed throughout the continental U.S. We've divided them into four regions: East, South, Midwest, and West. We do have a steering committee. On the steering committee we have a representative from each region, an at-large chairperson, and agency representatives from FDA, CDC, and NIH.

Now, we'll just go ahead and start off with the data. This is the actual total red cells for the community sites. The top red line is the inventory; the bottom blue is transfused; and in the middle there's a black line that represents the median daily inventory.

We actually have now a full year's supply worth of data, starting on August 15th of 2001, and I took it through the end of August 2002. And you can see the rise and fall. You can see September 11 and the aftermath. You can see the December/Christmas, January--early January drop.

Oh, good, how do I use it? He brought me a laser, but I'm technically challenged by it. Ah, okay. Thank you.

Here's the drop. And then, of course, this starts the summer--well, no, I'm sorry. This is the February, March, April, May, and then right in here starts--well, starts the summer drop-off, which is seasonal and expected. You can see also a little bit of--around the 1st of July a drop, and then also about mid-August.

Here's the total red cell for the hospitals. I'm not going to go through every single blood type, but I am going to show you O negative and O positive because I think there's some interesting points in that.

This is the total red cell for the hospitals. You can also see a rise and fall. It's not quite as significant as it is with the blood centers, but you can see here an increase in about early--it's probably about mid-July.

Also, this side line here, which is definitely more obvious with the hospitals, is just a drop-off in data entry. Not every site is able to enter on the same day.

Some of our sites are capable of entering the data the very--as of today, they'll enter today's data. Others are a couple of days behind because it takes them a while to calculate their transfused data. And, of course, from time to time an occasional site does get a few days behind, just staffing issues, vacation issues, and, of course, patients are their first priority.

This is the O negative from the community sites. There is a slightly different scale here we had to use in order to get the peaks in. You've got a really high peak here on day's inventory, so this scale is slightly larger than the rest of the slides that you have. But, again, you see the rise and fall.

Here's O negative for the hospitals, and you can see a little bit of a dip here, and that's early June. At the same time there was also a rise in the number of transfusions.

This is O positive. Of course, you've got a rise and fall. Now here's around the 1st of July where there's a drop to approximately as low as it was in the beginning of the data collection in August. It may have even dipped slightly below. But then, of course, there's a rise back and the data seems to have stabilized.

This is O positive for the hospitals, and, again, I'm concentrating on the summer because that's the most recent data. Here for about two weeks there was a gradual decline at approximately the same time as there was greater usage. But then at the beginning of July or the first or second week in July, you can see a drastic increase. A little bit of a drop here, again, but back up right after that.

I just wanted to show you the outdates. Of course, the most significant there is right after September 11. Other than that, they're pretty steady and very low.

We do ask questions daily, and these are the list of questions. Now, for the first four, they can quantify--well, they can indicate whether it was less than 24 hours or more than 24 hours. We've kind of considered the first three questions to be actual shortage, the next three to be threatened shortage, and the last three to be possible. We also have a free text space so that any site can augment the canned comment, or they can actually enter something that wasn't available through the canned comment.

This is a compilation of the actual shortage--or not actual but all of the shortage comments. You can see they peaked the last week of June, and that coincides with the data charts. There was a little bit of a rise again at the end of August, and it's too soon to tell. I do believe that that's dropped off, but with the lag in reporting we can't tell for certain.

We did notice when there was an increase in shortage comments that some sites had begun to comment that it took more than 24 hours to get their supply.

There are a few sites that seemed to have chronic shortage comments. There are also some sites that never have or seem to almost never--I never want to say totally never--have a shortage comment. The majority of the sites fall in the middle. They will from time to time have an issue. They may have it for a couple of days, or they may sporadically have comments. So we do get sort of a bell-shaped curve with the commenters.

I also want to let you know that we do have an agreement with the statistician to review the size of the sample.

Now, this slide just shows what we refer to as actual blood shortage, when surgery was cancelled or delayed because of lack of blood. You can't see them too well, but there are three dots there, the first being right here, which was an AB plasma issue. There's another dot somewhere in here, which was inability to get antigen-negative units at the last minute. I think it's over here. These are four dots together, and it was one of our sites that cancelled elective surgery for four days in a row, and that was in early to mid-July.

Also, if you--I'm not a statistician or a stats expert, but if this line represents the median of all the medians of each of the sites, then this site was below the median at the time of their problem.

Just a brief note no platelets because we do collect the same data on platelets. We collect the random and single donors separately. The inventory is much narrower. Virtually people get platelets as they need them, and there's minimal outdating, particularly for the single donor.

Just to show you the platelet shortage comments, they peaked back in December. I don't really know--I mean, one could speculate as to what the reason for that might be. And the platelet shortages have resulted in about 16 or 17 cases of cancelled or delayed surgeries.

That's my presentation for today. Thanks very much for your time and attention. Do we have time for questions or--

DR. BRECHER: I think we can take one or two questions.

DR. KLEIN: Thank you very much for the presentation. Obviously we haven't had time to analyze your data, but seeing that one of your sentinel sites had four days in a row where a surgery was postponed because of lack of blood, can you say anything about that nationally? Can you project anything based on the data that you have? Is this simply something that happened at one site, or is this representative of what is happening across the country at that time?

MS. WANAMAKER: I really--I mean, on my part that would be pure speculation, and I can only say that by looking at our sites, it was more of a regional issue or maybe even a site-specific issue.

DR. BRECHER: Ginny, this monitoring I think it's estimated it reflects about 10 percent of the blood collection and transfusion in the country. Is this data being useful for consumers, or is it just being collected and...

MS. WANAMAKER: Well, I can see a usefulness in it because you can clearly see trends and you can see the rise and fall. Of course, the seasonal shortages are to be expected, but this data is comprehensive in that it verifies some of the anecdotal comments, or it may either verify them or discount them. But what we've got here is actual hard, comprehensive data and, to my knowledge, data to this level and extent has not been collected before.

DR. BRECHER: Jay?

DR. EPSTEIN: These data suggest that for most of your sites and most of the time, the red cell inventory is between five and ten days, average of around seven to ten. And yet at least in the summer, there were numerous media reports of inventories as low as one day or one to three days. And I'm just wondering how one can reconcile that apparent discrepancy in what centers have been saying versus what the monitoring is saying.

MS. WANAMAKER: Well, I can tell you that--and I had meant to tell you earlier, but I'm glad you brought that up. The aggregate data, of course, loses or you miss the fact that there are some sites which have a much, much closer inventory-to-transfuse ratio than others. We do have some sites that carry a pretty large inventory. We have others that have a very, very short inventory. And I'm sure that's relatively consistent with the country because there are a number of sites that are going to have a much better inventory than others, particularly the O negative and O positive. There's a wide variation in the amount of inventory from site to site.

DR. EPSTEIN: If I could follow up, then, it may, in fact, not be useful to report the median. In other words, the median may be misleading us if, in fact, there's a very wide range, and any significant proportion of centers, in fact, have low inventories.

MS. WANAMAKER: That's a valid question, a valid suggestion.

DR. BRECHER: I was just thinking, to follow up on that, to be useful, if one site was short and was cancelling surgery, to have a database where they could quickly go to and say this center has excess, and maybe we could bring in inventory from there, that would be, I think, practical and useful. Karen?

MS. LIPTON: I was just going to make three comments. One was also on this median issue, which bothers me, because we do keep hearing from hospitals--and I know this is just 10 percent, but at the AABB we hear from hospitals that say we're really suffering here and this is critical. And then you hear from the blood centers. So there's something that we're not picking up here, and I don't know what it is. Maybe people are just, you know, jumping off of cliffs and they shouldn't be. But there is clearly a perception among hospitals and blood centers that things are tighter and more difficult to manage than they were. That's number one.

Number two, I'd just like to get back to two of the recommendations that we had that I don't think we're doing it, and one is public availability of this information, that it's easily understandable and accessible, and I know--you know, even if you were a lay person getting on this site, I mean, I don't know what this would necessarily tell you.

I think the other thing is that what just appears to me to be lacking in all of these things is this predictive modeling. And we've said this a number of times. I really hope that we don't lose sight of that. I'm not saying that this isn't a valid exercise. But without predictive models that let us know, we're not going to have made any headway here.

I also just wanted to note that, you know, when we had--when you pointed out that the inventory went up in July, we were out on a totally national unified appeal message then, and it is no surprise, then, that our inventories went up.

MS. WANAMAKER: The inventory does follow right on the heels of that.

MS. LIPTON: But I think what we would like to avoid is having to resort to that type of message all the time to pull inventories up.

DR. BRECHER: Mike?

COLONEL FITZPATRICK: Just to follow up on Karen, I think there is an apparent problem that we need to iron out between this 10 percent and what we're seeing otherwise. And I can show some of that in my talk.

The other would be that we've talked about this for a couple of years now, and we still don't have a method of intervention. And it's good data, but the data is not very useful if we don't intervene somehow to level out these peaks and valleys and provide a constant supply. And I think that we need to come up with--we have recommendations and we've made recommendations for interventions, and we need to find a way to provide some action on them.

DR. BRECHER: Okay. I think we need to move on. Thank you, Ginny.

MS. WANAMAKER: Okay. I just wanted to show you one quick point about the inventory. Even though we do have some sites with a large amount of inventory, if you hold any value to this, there is a point where all sites dipped to maybe three days' inventory of O positive.

DR. BRECHER: Okay. Thank you. Our next speaker is Alan Williams from the FDA talking on Trans-Net.

DR. WILLIAMS: Thank you. I'm Alan Williams. I'm Director of the Division of Blood Applications in the CBER Office of Blood Research and Review. What I'd like to do today is not compare and contrast the different studies and proposals that are under discussion today, but start out with just a couple of slides which are being loaded, really emphasizing--trying to target exactly what data we need to try to monitor the national supply, and then go into what FDA has put together as a proposal to specifically measure blood shortages around the country on a population-based model rather than a sampling model.

For the first aspect of data, what do we really need to know? I think there's a clear need for a long-term collection and utilization data collection mechanism to capture total collections both whole blood and specific blood components, look at utilization and especially if that could be done by specific ICD code or transfusion indication. Such a system should have the capacity for ad hoc collection of operational data which might be put into place in any given year. The data should be available publicly and within a short time frame, if possible, and optimally would be updated annually.

This is similar to some systems that are currently in place, but there are some differences as well, but I think having an annual system like this in place with readily available data would be a real addition to our knowledge base as far as what's going on in the current transfusion world.

The second system I'd like to mention, I think we need much more intense monitoring of the breadth, the impact, and the duration of blood and reagent shortages pertaining to blood collection. This could be done either by a quite large sample which would provide good representation for the entire country, or even on a population basis, which is what we're proposing, that all potential users would have a voice. Certainly there'd be a certain amount of noise reporting, but that could be adjusted out so that you could actually set a cut-off threshold.

Data, if possible, should be available in real time. One of the potential applications is, as Mark suggested, the ability to know if you don't have blood, where is it, to allow that sort of real-time capability.

Although the system I'll discuss doesn't specifically go into specific blood types, clearly I think a monitoring system can be reliably put together looking at Group O red cells and platelets. If you have Group O, you have blood. And I'm not sure that the other types on a picture of a national basis are quite as important, but that may be debatable.

Such a system should allow tracking of time trends and allow a relationship to interventions, both positive and negative interventions. Certainly in implementing any sort of donor screening policy which may impact donor eligibility, FDA would like to know whether the supply is healthy at the time of intervention or not.

Similarly, if there's a national campaign, one would want to know how that impacts the prevalence of shortages and how long that impact would be sustained. The data should be easily interpreted. Shortage alerts ideally should carry both a collection center perspective and a transfusion service perspective, because this is really a very complex system. If you don't have both sides in hand, it's hard to figure out exactly what's going on. And the system should have flexibility to meet future data needs.

What I'm going to go on and do is propose or describe to you a system that's been under development within FDA for the past several months. We've called it Trans-Net. And what it is is a Web-based voluntary reporting system for the real-time identification of shortages of blood, blood components, and reagents or supplies.

Manette Niu in the Office of Blood is a principal investigator. Sharyn Orton, Stan Pawlowski, Amy El-Naggar, and I are co-investigators.

Since April, we've been developing the program in close consultation with 12 hospital transfusion services and blood centers, looking at the best mechanisms for collecting data, defining workable shortage criteria, ways that data might be used and ways to enhance participation, because we're really looking for voluntary participation in the program. That's probably the biggest hurdle that the program faces.

The design recommendations we received: One, keep it simple. Utilize data, if possible, that's routinely collected by the facility. Have daily reporting with a simple no-shortage single keystroke reporting arm which would cover most situations. Recognize local variations in the definition of shortages. As we heard from Dr. Snyder at the last meeting, at his facility they have a defined internal shortage criteria which will tell them to go to their frozen repository.

These aren't the same across all institutions. They're somewhat unique by the institutions, so we want to try to recognize that in defining shortages at an individual site.

And recognizing that all sites at this point may still not have Internet access, we wanted to investigate alternate reporting methods.

Incentives for participation given that this is proposed as a voluntary program would be rapid, accurate data availability and meaningful use of the collected data.

The design is population-based. This would encompass 3,000-plus transfusion services and 150, give or take a few, blood collection centers. All will be eligible to participate. However, we want participation to be predictable. We'd like the sites to register so we have some brief contact information should we need to go back and verify information. This would also permit follow-up and tracking for consistent participation in the program.

The data will be automated in a simple manner. The thought is that there would be an outgoing e-mail to prompt our daily response. This could be made either with a keystroke which will tie into a Web reporting site, and most recently we've also been looking at a telephone reporting system where there is no Internet access in that a call would come out and simply using the touch-tone, one can make a quick data entry over the telephone system, equally simple, and this is automated and is added to the database.

This is an example of what an intake form might look like for the outgoing e-mail. It would be controlled through a blood facility ID, single keystroke reporting for no shortage. If a site feels they have a shortage, it then takes you into a criteria page which then defines those, which I'll show you in a moment.

Now, shortages may--definitions may vary. They could vary by hospital, by blood center, by geographic region. They could change over time, and supply networks are convoluted. Certainly that impacts whether or not a facility can get the blood it needs.

At the blood center side, we've considered the following factors: whether there was a media appeal saying that blood is in critical short supply; whether orders have been cut; whether there has been use of a strategic reserve or frozen inventory; whether a site that normally exports has cut its exports to other sites; whether a site is importing from alternate sources; whether there's been prospective filling of back orders; and other factors that would be write-in data fields.

This would be the second-tier screen that if a site chooses to report a factor, they would simply check it off here or enter information in the box.

On the transfusion service side, the factors are similar to those mentioned by Ginny. They include delayed surgery, non-routine support of Rh-negative patients with positive blood, incomplete orders received, purchased from a supplier not routinely used, double cross-matching, early release of cross-matched blood, and also a free text field.

The data, once received at the central site, would be mapped into a central database and then reported into mapping software using our GIS program. Because facilities are registered, any reports that would appear to raise suspicion or be of particular interest would be available for verification and follow-up, and this would be a manual process. And the software would provide mapping which in essentially real time would be available not only to those monitoring the system but to the general public through a Web access.

In addition, the software can be set at threshold levels based on the frequency of reports received, the time trending of those reports, and you can actually set a threshold to put out an alert which will draw particular attention.

On the mapping side, it will operate from an Oracle database. The GIS mapping will provide a map; it could be at a national level or even drill down to a state, county, or smaller level. But we have to be careful not to allow individual identification of participants so the drill-down capability would be limited to not fewer than five respondents.

This is a sample of what GIS software looks like. You've all seen this sort of map. This is simply, I believe, a county representation of the Washington metropolitan area, and one can color-code areas with different characteristics. These are not real data. It's simply an example. And then this would be a drill-down of a closer area where one can actually see very readily a color-coded representation of the situation.

We anticipate after the program is implemented there will be a need to adjust the sensitivity and specificity; particularly, we don't know what level of normal shortage reporting might occur, and there certainly would be some. So one would need to set a threshold.

We need to evaluate sites that fail to use the system consistently because we need an accurate denominator for reporting as well as a numerator to know what is being reported. And we probably will need to consider weighting some variables based on respondent characteristics, whether the data are coming from a collection center or a transfusion service. For instance, size of a particular facility may make a big difference.

So how are data to be used? This is a very important question. FDA does not control recruitment. It doesn't control movement of blood around the country. That's largely business practice. So FDA is not in a position to influence that. However, I think data of these type, if referred to an entity such as the AABB Interorganizational Task Force, would be of tremendous value so that the organizations that do have the power to call on the reserves and national blood exchange and similar facilities would be able to respond to the data.

On the other hand, in looking at reagent and supply shortages, they can occur in a natural manufacturing situation. Obviously they can occur in some sort of terrorism event. FDA does have a little more ability to investigate those types of shortages, to speak with the manufacturers, help to facilitate lot release if necessary, and generally get a good handle on whether the shortage is real or based on an anecdotal report, which comes in fairly frequently.

It will allow us the ability to have objective evaluation of policy impact. Implementation could be weighed against the current national blood availability situation. And impact could be monitored closely after policy is implemented.

The final thought, it's a little bit wild, but the idea is--a thought you'll commonly hear from blood bankers is you need to ask donors on a regular basis to get them to come back. So we thought something like a blood thermometer based on the data made available widely in the media, imagine, you know, in the top left corner of USA Today, where the public is constantly aware of what the blood supply is both nationally and in their particular area. These type of data would support that type of facility, which would help keep donation in the public eye.

Then the final comment is that disruptions of blood and reagent supplies are very likely an outgrowth of both terrorist activities and even the planning process for counterterrorism, such as Karen mentioned. Interventions related to smallpox are likely to have an impact on blood donor eligibility, and we need to consider this. Real-time data will allow identification of regional areas that are in need of help as well as those without blood and reagent shortages that may be able to provide assistance.

And the system we're proposing, Trans-Net will also provide a flexible data collection conduit that can be applied ad hoc to other critical data needs as part of overall CT efforts. For instance, a site that has potentially been exposed to a Bt agent like anthrax, one would need a rapid means to notify and collect data from sites that may have possibly had a blood collection in an exposed area and be able to manage that information.

The program has really reached the late stages of development. We've defined the pilot team which is going to start working on this next month. We've submitted a request to OMB for emergency review, and once we've crossed those hurdles, we will begin to make the program known more widely and hope for wide participation. Thanks.

DR. BRECHER: Thank you. Karen?

MS. LIPTON: I just have a couple questions. Now we've heard of the HHS monitoring system and this system. Are there efforts to coordinate these two? I mean, it seems we started down one path within HHS and invested some significant resources, and now I see this and I don't know what the cost of this is, and it may actually be minimal because it's Web-based. But it just seems to me that we ought to be making an effort to put these two thing together rather than going off in different directions. And I don't actually know what the plans are for the HHS monitoring system.

Let me just say, my second question--and I'm actually more concerned about this--is this idea of a regional blood thermometer, I mean, we've just talked about a unified message and making sure we do the same thing. So although I think that's a good idea, I think you have to communicate what you're going to say to the public with the local blood collector because you could be giving out a very different message. And also, in disasters, I mean, we've tried to focus all disaster communications to the AABB task force, and we don't want them to think, well, I have to do AABB task force but then I also have to do this.

I think it's just a coordination issue, but I think we need to be very careful that we're not starting to--we've tried very hard to come up with a unified system, and now we're sort of drifting in different directions.

DR. WILLIAMS: I agree with that comment, and certainly regional blood recruitment activities will continue to be done in earnest when there is a regional specific shortages. I think that's kind of the thought that there was.

You know, I'm hoping this would be potentially a nationally utilized system, and certainly coordination is important, and I think there's still plenty of time and interest in doing that.

With respect to the relationship with the current DHHS program, as I said, I'm not attempting to compare and contrast programs. I view the HHS program largely as an inventory monitoring system. Should, you know, the desire be to detect how many sites are, in fact, maintaining the desired seven-day supply, this type of system would help give that to you because Trans-Net is not a quantitative system. It's a shortage detection system. And on that basis, I think it's more sensitive and specific than the other one, but the other is an inventory monitoring system. I think they're compatible--

MS. LIPTON: But I thought the other one was a sentinel system also and not really an inventory management.

DR. WILLIAMS: Well, I think referring to some comments that were made, you know, earlier at the meeting, what's the reliability if you see something in a single site that represents something larger than might be going on in the country. I'm not sure there's confidence at this point that it is a sufficiently large sample, even if representative, to reflect the local and regional situation around the country.

DR. BRECHER: Jay?

DR. EPSTEIN: While I'm in agreement with what Alan has said, I just want to add a few perspectives.

First is sort of a famous law of politics, which is, Think global but act local. And I think that's what we're talking about here, that we need the national view but, of course, donor campaigns are always local campaigns and come down to bringing in individuals. So I don't think that those perspectives are incompatible.

Secondly, I think that Alan has made the case that we need a variety of monitoring tools that have different objectives. We need long-term monitoring to look at the large trends--blood utilization, changes in clinical care, differing indications for transfusion, changing demographics on the source of blood, changing patterns of blood distribution, and so forth. So that's the long-term data.

We do need quantitative data on inventory management which speaks directly to the question of where is the blood. And I think that Alan has made a very good case that we need a more real-time system to monitor acute shortages so that we know when we're having a problem. So I think that the idea here is that with the sensitive tool for national monitoring of regional shortages, we answer the question: Is there a problem today? With the inventory management system, we answer the question of: Is blood available and where? And with the long-term trending, we answer the question of: Are there aggregate system problems that need to be addressed in how we're collecting and utilizing blood?

So I think that what's ended up happening over time, even though we've moved down this pathway in fits and starts with different efforts to monitor different things, we are starting to get our hands around a spectrum of data that will equip us really to look at and manage the system. And I think that, you know, Mike Fitzpatrick hit the nail on the head when he said the missing ingredient is the intervention strategy, because we don't yet have an organized system to move the blood from where it is to where it's needed. But, of course, knowing where it's needed is sort of a threshold question.

And I think that one of the issues that has been the most difficult to figure out is how to look at the inventory pattern. What the department has put in place is what's been called the sentinel monitoring system, which, although quantitative, only looks at a selected number of centers, and questions have been raised repeatedly whether it's giving us an accurate national picture.

The point has been made many times in the past that there are, in fact, better data sources of inventory within the blood industry. I mean, Red Cross on a daily basis knows where all its blood is, and I believe that America's Blood Centers knows that, too. But those data are not being compiled into a national picture, and, in fact, they could be, or at least potentially they could be.

So I think that there is room for improvement in all three areas. Trans-Net is not yet up and running, but, you know, certainly at FDA we think this is a good addition to the surveillance base. The inventory management system seems to suffer not just from statistical analytical limitations but from the question of what should be the data set. And then I think that we have not clearly supported the long-term surveillance to the level needed. Alan has gently suggested that maybe annual data would be better than biennial data, and, again, there would be the question of is it adequately comprehensive. But certainly we have all made tremendous use of the NBDRC reports, and we're going to hear about that very shortly.

So that's my effort to sort of put the picture together. I think that we're looking at, you know, the different parts of the elephant and that what we're trying to work toward is the global vision.

MS. LIPTON: I think that what you just articulated is understandable. I guess from a committee standpoint it would be helpful to see that rationale articulated so we know why we're looking at different projects. And, again, maybe the HHS system is now an inventory management, but three times up there it's been represented as a sentinel. And so I just think--I mean, if we say these are the three pieces that are evolving and we think we need it, it would just be helpful from a committee perspective to understand that as this evolves, this is now what we think we need and this is how we think we should fill it. Otherwise, I feel like we get the project of the day and we're not quite sure where it fits into the picture.

DR. EPSTEIN: Well, I would just say that I have not been trying to describe what people thought they were doing, just my vision of what we need to be looking at and the extent to which these different approaches address the need.

DR. BRECHER: Harvey?

DR. KLEIN: Alan, I really want to commend you. I think this committee has asked repeatedly for a statistically sound analytical tool, and I think you're developing one that will give us some data that we need in real time. And I for one really am very anxious to see the data as this system gets up, and I thank you. I have two questions, however.

One is: Is there a long-term commitment? Because the worst thing that I think a government agency can do is to set up something that's really helpful and then see it dwindle or disappear.

And the second question is: Are there thoughts about adding plasma derivatives to this kind of a system?

DR. WILLIAMS: Regarding long-term commitment, the comment came up earlier that, well, probably it isn't too expensive because it's a Web-based system. Well, the primary expense is in the development and in the software purchase, and that's been done. Maintenance largely consists of staffing, software maintenance, and data management. You know, I wouldn't want to shun the idea of getting some additional money to fund the program, but it is a manageable amount. It's a low-budget project, actually.

DR. BRECHER: It seems to me that we've got, as Karen said, two government-funded operations, and I think the two need to talk together and work out some priorities, and maybe we can come back in our open discussion.

I have one other question for you, Alan. You had your entry screens, was shortage, no shortage. But are you going be collecting any quantitative data or at least asking do you have an excess? That would seem like a simple third choice.

DR. WILLIAMS: We have not considered that. It's something we could think about. But you're right. A single keystroke, no shortage, and then if you have a shortage, then it refers you to the criteria screen.

We have not looked at the excess picture. That would require some definitions as well. But it could be an add-on, I agree.

Harvey, with respect to your question, also plasma derivatives is a potential add-on, but we have not considered it in this first phase. I think the system is flexible that it could be applied to a lot of different areas like that.

DR. BRECHER: Okay. Last comment. Jay?

DR. EPSTEIN: Well, I just want to sound a little bit more cautionary note on the question of whether there's stable funding for these initiatives, because my perspective is that there is not. The question was raised all the way back in November '99 about whether the government should play a primary role in this blood system monitoring. We decided that we should. However, we've approached it with a system of Band-aids. I mean, we've had funding from different sources at different points in time on different initiatives, some of which have continued and some of which have not. And I think that the reality here is that there is still not an enduring commitment through any programmatic mechanism. In other words, there's no stable base funding. There's no part of government that has ownership of blood supply monitoring as a programmatic function.

So, you know, the various components of government I think have stepped forward to do what they can within their limitations, and that's good. But we shouldn't kid ourselves that that's the same thing as, you know, a program mandate or a programmatic commitment. It's something short of that.

DR. BRECHER: Okay. Thank you. Let's move on to the next speaker, James MacPherson, from America's Blood Centers.

MR. MacPHERSON: Thank you, Dr. Brecher, Dr. Slater, members of the committee. I appreciate the opportunity to present what I think is a really interesting tool here, and while my presentation is being loaded, let me just make a couple comments.

First, my presentation can be shortened a little bit because Dr. Williams has just made my presentation. We have taken what he has talked about, and we have implemented it, at least for half the blood supply related to blood centers, and we did it for less than $20,000. And the ongoing costs of this are in the hundreds of dollars per month.

The other thing that I think--just to comment on Dr. Epstein's and Dr. Williams' comments--is the idea that FDA would intervene in shortages I think will have a chilling effect on the voluntary participation in any government-run program. The whole idea of Big Brother moving the blood around or investigating as to why people are having shortages in some areas and not in others I think will have a difficult road to hoe.

While I agree with Dr. Fitzpatrick and other people who have said that we need to work on better strategies to make sure that the blood is evenly put around, I don't think that government intervention is the way to get it. I also don't think you're going to get participation in the program that way.

One of the things that we found out in even talking with our own members is many of them don't go public about their shortages. They quietly try to address them. They may go to the media once in a while. Some go to the media often. But they don't want it known to the public in many cases that they're out calling more donors in or scheduling more drives.

Hospitals, too, don't want it reported when they cancel surgeries or when they waste organs because, again, that sends a message out to the public about the quality of the hospital.

Anyway, let me go on with the presentation here, and I'll try to be as quick as possible.

I think you all know who we are. We're the federation of the community blood centers that provide just about half the U.S. blood supply. We now have gone international as well, and one of our members now provides about 25 of the Canadian blood supply. It's all volunteer donor, obviously, and there's about over seven million donations--if you subtract out Canada, the Canadian member, it's about seven million in the U.S., and those donations are made into two million blood components that go to over two million patients at 3,300 hospitals.

Again, this is stuff most of you already know. I think a couple key points is that our members already share among themselves about a half a million blood components, most of that being red blood cells, every year. They do it through direct and long-term contracts, which are the best way to address chronic shortage areas in the country, and I think there are a number of spot market mechanisms which I'll talk about in a second.

Just by happenstance of geography, it was our members that provided the blood for the victims of the Oklahoma City bombing, Columbine, and September 11th, so obviously we have a lot of history and experience in dealing with major disasters.

One of the complicating factors in monitoring blood center supply versus hospital supply is that the growing trend of our members is to be the hospital transfusion service, and, of course, Seattle has been doing this for over 50 years, but now many of our members are now the hospital transfusion services in Milwaukee and Denver for the majority or many of the hospitals in that area. And so when you start talking about monitoring inventory and managing inventory, you have a regional management that's vertically integrated all the way up to the patient.

Now, just a couple background points that I think are important to talk about to put this all in a perspective. We have just completed a study that we hope to have published within the next 60 days. We're doing some peer reviewing right now. But over one in five hospital admissions are blood- dependent. That means that if you look at the DRGs, that includes significant amounts of blood in them; that accounts for over 20 percent of all hospital admissions.

It varies quite a bit if you talk about tertiary care hospitals. It's over a third. If you're talking about more rural hospitals, it's about 10 percent.

As you all know, blood is used to primarily support trauma, organ transplants, marrow transplants, and the need for blood is growing. Last year, there were about 15 million blood donations in the United States. Over four million--the estimate is now four and a half million received blood transfusions, and several studies have shown that about half of all transfusions are urgent and life-saving. What that means is that potentially two million Americans would die if the blood transfusions weren't there.

What about the others? Well, that's elective use in many cases for what we call elective surgery. It doesn't mean it's not life-saving surgery, but very often it can be postponed and moved around.

Now, the demand, as I said, for blood is increasing. As we boomers are getting older, we're using more blood, having more therapies, plus medicine is advancing in the sense that it is becoming more blood rather than less blood intensive. While we figure out how not to use blood in some areas, we find new areas on how to use blood.

We expect that the blood demand will increase 5 to 7 percent in the U.S. over the next five years. That's a crystal-ball figure. And blood substitutes are at least three to five years away, and I think the belief is, general belief, they will only replace about 10 to 15 percent of the demand, that is, the blood that's already shed in the emergency room or surgical suite floor, that's probably where the substitutes will work best.

Now, in monitoring the blood supply and making it meaningful, we had some of the exact same challenges to try to address as Dr. Williams nicely outlined, so I won't have to go through them in any great detail.

The first thing was to keep it simple, to keep it low cost, to keep it meaningful, and also to keep it confidential, because, as I said, you get more participation if you protect the sources of the data.

There is the question that we're talking about even here. We can't monitor the hospital inventory, but when you examine the question of blood center versus hospital inventory, I think we have to keep in mind that blood centers normally move their inventories to hospitals as soon as the components are available. They keep a small amount of blood on hand as back-up supply. So the hospitals actually feel the shortages later than the blood centers do.

One of the phenomena that we hear all the time is when a blood center goes out on media appeal, the first thing that the reporters do is call the hospitals and want to know how many people have died or how many surgeries have been cancelled, and hospitals says, Well, I don't know what you're talking about, we have plenty of blood. And, again, this is the blood center going out first to try to prevent any shortages in the hospital itself, while they'll try to keep the stock for their hospitals fairly high.

What do you want to monitor? Well, Dr. Williams talked a lot about some of the issues that you have to consider. Do you want to monitor absolute numbers? They're very difficult to get and really, even though the blood centers have electronic mechanisms to do that internally, they're all different electronic systems, and interfaces would be very difficult. But it can be done. It's just it will take a lot of resources to do it. And, you know, we're looking at are there simple ways of doing that ourselves, and I think everybody's looking at that.

Then the question of: What do the numbers mean, and how do you translate those numbers into something that is meaningful to the public, is meaningful to the industry, is meaningful to officials who have to look at this, is meaningful to the media who is interested in reporting this to the public.

So we came down and we just decided, well, let's use days of supply because that's a meaningful figure to us, and now we can try to make that a meaningful figure to the public and to the other stakeholders.

Now, a one-day supply to us--and I think there are slight variations on this definition, but the way we standardized on the definition was a one-day supply is equal to one day's net collections, after you take out all the outdates and everything else. And so it's just a simple number. In our case you take seven million or 7.2 million and divide it by 365, and that's the number that you come up with.

Now, what does that mean for the hospitals? Well, that usually means one day's usage, because since only 2 percent of blood outdates at any one particular time, that means that one day--one day's supply means one-day usage across the country.

Now, we're talking about for ABC members, again, we're the federation of the community blood centers. That's about half the blood supply, and that's about 20,000 units of red blood cells is a one-day supply. What we consider a good inventory in a blood center is a three- to five-day supply. That's somewhere between 60,000 and 100,000 units of red blood cells. A good hospital inventory, for the most part, is a five- to seven-day supply. A lot of that is on cross-matched or committed to patients, so that's about 100,000 to 140,000 units of red cells. And so a total good supply for at least the ABC, half of the country, if you will, is between 160,000 and 240,000 units.

That's a lot of blood in the system at any one time. But as I said, it's all in different parts of the country and some rural parts, and a lot of it's cross-matched and already committed.

Well, what's an adequate blood supply? And I think that's part of what the committee's charge is today, to try to see if--and there's going to be some discussion of this and presentations this afternoon. But just to give you some thoughts as we go through this, I think the answer depends upon the degree of preparation required and your ability to mobilize donors in inventory at any one particular time.

One liver transplant can consume up to 150 Group O red blood cells, which could be a one-day supply for the average blood center around the country. And they could be in a critical shortage by just having to worry about one liver transplant. This is true in Pittsburgh all the time. That seems to be in chronic shortages these days because they're doing a lot of liver transplants.

Columbine used hundreds, Oklahoma City used thousands of units of blood. What kind of disaster are we preparing for other than the kinds of disasters we've already seen? 9/11 is one of the reasons why we're discussing this, but, on the other hand, 9/11 used, I believe, between 400 and 600 units of blood.

Following the September 11th attacks, our members collected nine days of supply within 48 hours. But they were running out of collection bags, test reagents, other kinds of things, problems that we're still trying to figure out how to address today. What happens if the airports are closed again? And with manufacturers on just-in-time inventory deliveries, these become difficult problems.

A lot of our members are now thinking of doing testing again that had stopped doing testing because they couldn't get their blood tested. And so they had difficulty not so much with red cells that were sitting on the shelf, but with platelets that needed to be replenished every day.

Tens of thousands of units of red cells were mobilized to go to New York, but the airports were closed and communications were poor, and as we all know, the needs were very minuscule.

So how do you prepare for massive trauma? Well, after September 11th, the Red Cross stated its inventory intent to maintain a 15-day blood center supply, and my understanding is it's nowhere near that today. ABC said--and we echoed Mike Fitzpatrick's comment, stole a comment from him that he made publicly--that the best place to store blood is in the donor. I think, again, this is a question that the committee is going to talk about today. I don't know what the answer is, whether in the country we should have a five-day supply nationally, a ten-day supply or a 20-day supply.

So let me talk about the Stoplight, which is, I think, the main reason I was here, and, again, this won't take as long as you think. I'll just let the graphic go through so you can see why this is a seven-megabyte file.

The Stoplight is Phase 1 of a two-stage Internet-based project that we launched a year ago. Phase 1 was to monitor the day's supply of member inventory and to do it simply and graphically.

Phase 2 is to put in place a more active mechanism for showing members where excesses are, not just shortages. We already have a mechanism, an Internet-based mechanism in place for alerting members as to shortages. And that seems to have been actually fairly effective, except now that we have so many centers on shortage, we're concerned a bit that the messages are coming frequently. And instead of people responding to one or two messages a week, they're now seeing three or four messages a day. And I'm sure that members that have excess are responding as best they can. But there becomes the phenomenon of too much, too many messages, and just like when blood centers go public too often, the public doesn't respond. Well, I think the same thing is going to happen if we're having five to ten messages a day of shortages between members. I don't think we're going to see the response that we had hoped, or at least the response that we have seen in the past.

How does the Stoplight work? Very simple. Blood centers already perform inventory at a set time. It varies between 9:00 p.m. usually and 7:00 a.m. in the morning. They calculate--they already do this. They did this before we even asked them to do this. They calculate a day's supply on hand using Group O as the lead indicator. Every day at 6:00 a.m., an e-mail is generated. We only do Monday through Friday because we're having enough--we're having hard enough trouble with people responding to e-mail Monday through Friday, so we don't do it on weekends yet.

But an e-mail is automatically generated to two contacts in the blood center--one is back-up--with three links on the e-mail. We give the definitions, which I'll show you in a second, as to what the--just to remind them if they need to know what red, yellow, and green mean. And we give them three links to a server back at our office that is linked to an Oracle database, and that's where all the software resides and other calculations, the number reside.

The database contains the blood center's annual collections and calculates the percentage of the ABC's supply in red, yellow, and green. The database updates the calculations and trend data on the website, and so it's instantaneous. You can go in and you can see minute by minute any update on how it happens.

These are the definitions. I'm not going to go through them, but it took us a while to get consensus from the members. They're not as complicated as it looks if you read through them, but these are the definitions that all the members have accepted in terms of what does green mean, what does yellow mean, what does red mean. The only variation I would say is that some centers will go red when they have a two-day supply, some will go red when they have a three-day supply. It all depends what they're used to and how their system works.

So what we did was we gave the definition, and everyone has agreed what is red, what is yellow, what is green, and if it's a little bit different for them internally, the system works.

Now, if you go to the ABC website, you'll see a traffic light over in the corner, and you click on the traffic light, and it will take you into some fairly crude graphics right now. We're going to be updating these within the next 60 days. But what you see is a map we've divided into quadrants--not quadrants, actually five sections of the country. I believe these roughly are equivalent to what HHS is monitoring in terms of their quadrants or their sections of the country.

It is quadrants.

We actually provide actual numbers, which probably for most people are very hard to follow and hard to read, but the numbers are all there in terms of calculations that I mentioned before. And the calculations are there for each region of the country. And then we have the entire nation number. We actually have--because we want the regional breakdowns, we have split our 74 U.S. members into actually 94 members that respond, and then it gives you the percent of the blood supply that's in red, yellow, blue, not the number of members, not the number of centers, but the percent of the blood supply.

If you want to know what that means nationally, you just divide it in half because, again, if we're half the blood supply, then that number represents half the blood.

Oops. That's not a good graphic, anyway, so we'll go...

This, we also used some trend data, so you can click on links on the website and see the trend data so you can see what percentage is in red, yellow, green. You can also see what percentage of members don't respond. As I said, it's not--all the members respond but not all the time. So it's not a perfect system, but we're working on it.

We also publish in our newsletter that I'm sure a lot of you see, we publish trend data so that you can see for the last few weeks where the blood supply has been. This has been an unusually bad summer. And if you look--you really want to focus on yellow--on yellow and red because that sort of tells you the preparedness. And the number in red means that there's a real problem in that region.

So my conclusion on this, it's a start for us. We know it's not perfect, but it does provide a meaningful and graphic marker of supply. We've worked through many of the problems that FDA is going to find that they're going to be working through in their system.

We need a better way to monitor the impact of acute shortages, and we're not the ones to do it because we don't go into the hospitals that much, although, as I said, many of our blood centers are hospital transfusion services. But I don't think we're the best ones to do it at this point.

I know CBER's system will try to intend to do that. I just would say that the question of confidentiality and how you're going to maintain that data confidentially and not start calling up hospitals and saying, What's going on? and Are those reports going to get to the media?, et cetera, I think that's going to be a big problem.

The next phase I mentioned already is a more efficient way to identify and share excesses. We already have an Internet-based research sharing system that's not utilized very much, but we've figured out some ways that we think that we can make it a lot easier for people. And, of course, the most important thing is that we all collect more blood.

Thank you.

DR. BRECHER: Thank you, Jim. We have time for a few comments or questions. Ron?

DR. GILCHER: First of all, I want to correct one of the remarks that was made by Jim. We didn't use thousands in the Oklahoma City bombing. We used about 300 units in a very short period of time, which clearly was life-saving and life-sustaining.

I made a calculation, though, that I think is important to present to the committee, and it represents really what happens at our blood center, the Oklahoma Blood Institute. Jim, I calculated to have 100 transfusable red cell units, we would need to have 111 collections because of various kinds of losses. But we would have to have 128 donors present because of the deferrals.

So taking that 100 over 128, 78 percent of donors that are presenting in our system on the average will end up as a potentially transfusable unit, and I think that can put it into perspective about the number of donors that we need to access in order to have transfusable units.

DR. BRECHER: All right. Why don't we take a 15-minute break. Then we'll come back at 10:30.

[Recess.]

DR. BRECHER: Could everybody take their seats and we can get started again? Thirty seconds.

Okay. The next speaker is Marian Sullivan talking about the National Blood Data Resource Center.

MS. SULLIVAN: Good morning. The National Blood Data Resource Center is an independent, not-for-profit organization that was founded by the American Association of Blood Banks in 1997. Over the past five years, we have collected, analyzed, and disseminated blood data that have been shared with us by every U.S. blood center and more than 3,000 hospitals.

We employ a variety of methods of data collection and statistical analysis, and our major activities that address blood availability are listed on this slide. I'll use examples from most of these studies in the course of my presentation.

Excuse me just a moment.

[Pause.]

MS. SULLIVAN: Sorry about that.

The point that I'd like to make from this slide is that we've built in some degree of overlap between many of our data collection methods as well as repetition over time, and this now allows us the benefit of substantial cross-validation of the data captured by different methods or at different times, which improves the overall accuracy of our estimates.

Our efforts to understand the dynamics of blood availability have evolved into a strong, three-faceted approach, each of which I'll discuss in detail.

At the top of the triangle is characterization. The cornerstone of our organization is the Nationwide Blood Collection and Utilization Survey, which provides us with detailed information on blood services activities in U.S. blood centers and hospitals. Most importantly, it allows us to continue the analysis of long-term trends in collection and transfusion begun in the 1970s by the National Heart and Lung Institute and furthered by the Center for Blood Research. This trend analysis is central to our understanding of blood supply and demand.

Conducted every other year, the nationwide survey is a detailed and largely quantitative questionnaire designed to provide national estimates for many of the key variables related to the collection, processing, modification, and transfusion of blood. We recently completed data collection for 2001: 138 blood centers, representing nearly 98 percent of U.S. blood center collections, and just over 1,300 hospitals; 56 percent of our hospital sample responded. I'd like to share with you some preliminary results.

Most of you have seen this graph before. It illustrates the trends in blood collection and transfusion since 1987, combining national estimates generated by the Center for Blood Research with NBDRC results for 1997, 1999, and we've just added 2001. It also illustrates the narrowing margin between collection and transfusion over time.

Last year at this time, we had just completed our Web-based QuiKount survey of U.S. blood centers. We weighted those data to account for hospital collections, which resulted in a national estimate for 2000 of 13.4 million allogeneic units, which was not statistically different from our national estimate for 1999.

QuiKount also measured collections in the first six months of 2001, and by extrapolation, we predicted that allogeneic collections in 2001 would reach 13.9 million. And that's depicted by the dotted line. But the tragic events of September 11th changed all that, and we now know that total collections exceeded 15 million in 2000 and our national estimate for allogeneic units collected is 14.8.

I had hoped to be ready to give you our 2001 transfusion estimate as well today, but we haven't finished the calculations. I can tell you that the rate of increase in demand exceeded the 5 percent per year that we had measured in 1999.

The nationwide survey also captured the number of days on which elective surgeries were cancelled due specifically to red cell inventory shortages. In 2001, 139 of the 1,086 hospitals reported cancelled surgeries on one or more days. The number of days reported ranged from 1 to 63, with a median of 2.0 for those reporting any days of cancellation other than zero. The mean number of days for all hospitals, regardless of response, was 0.56. And the actual number of surgeries cancelled was reported by 113 hospitals and totaled 896.

Also show on this slide are the results for this same variable from our previous two surveys in 1997 and 1999. Comparing 1999 to 2001, we do notice significant increase with a p value of 0.02 in the number of hospitals reporting days of cancelled surgeries. This is clearly an interesting trend. It's one that we feel that it's important to continue to track, but admittedly, it's difficult to interpret without the additional details of each occurrence.

The second facet of our efforts is monitoring. In January 2000, the NBDRC began the collection of monthly data from a sample of U.S. blood centers at the request of the NHLBI. Oversight of this monitoring activity was transferred to the Office of Public Health and Science in 2001, and our funding was discontinued in January 2002. However, recognizing the value of this dense time series of data and the willingness of the blood centers to continue to voluntarily provide the monthly data to the NBDRC, we've continued to collect the monthly data.

The sample consists of 25 blood centers and includes both American Red Cross and community blood centers. Collectively, the sample accounts for 32 percent of U.S. blood center collections. It's representative of all centers that collect more than 20,000 units annually. Data are submitted electronically by the tenth day of the subsequent month, and at this point, we have 31 months' worth of data for this sample.

As many of you know, the data variables were selected by Dr. Paul McCurdy, a consultant to NHLBI at the time. We capture monthly data for whole blood and red cells by blood group and type and platelets of both types. The variables are units collected, units released for distribution, imports, exports, and outdates. And we get inventory data on a twice-monthly basis.

Early on, we attempted to capture data on delayed provision of blood and units ordered versus units shipped, but it was soon evident that the blood centers do not track this information, and we've abandoned that. We also collected U.K. deferral data successfully, but eliminated that about a year ago.

Here are some of the data. This is monthly collection data for 2001 and 2002. This monthly data was particularly useful to us in the months after September 11th in tracking the rise and fall in collections at both the regional and national levels. In September of 2001, collections increased by 38 percent over the monthly average to 473,000. October collections totaled 406,000. And in November collections fell to 337,000, which was not statistically significant from the collections for August.

The donations in excess of what was expected based on the average of monthly collections for January through August of 2001 totaled 191,000 for the sample. We estimated at the time that nationally 600,000 additional units were donated through blood centers, and this has been confirmed by the 2002 survey.

An unexpected event such as you see here is referred to by forecasters as a loading event. And loading events are almost always followed by a de-loading, and that's certainly what we saw in December of 2001 when collections fell to their lowest level of the year at 319,000 units. Thus far this year, collections have remained--the red lines, collections have remained statistically unchanged, with the exception of April, which is the only statistically significant difference versus last year.

This slide illustrates units released for distribution for all three years of monitoring. Over the long term, these data are the best surrogate that we have for demand in the absence of hospital usage data. The curve for 2000 is the dark purple line on the bottom; 2001 in blue is recognizable, again, because of the September 11th effect. We measured a significant increase of 5.1 percent prior to September 11th in 2000 in comparison with 2001. And, thus far, 2002 has not been different in terms of distribution from 2001.

Here we have a denser time series of data because these inventory data are collected twice monthly. Also note the difference in the scale on the y axis.

In each of the three monitoring years, we see, not surprisingly, a trend of lower inventory levels in the summer months. This was particularly true last year in late August and the first week of September. After September 11th, total inventory increased from 29,000 units to 113,000 units by the third week of October, after which the curve began to level off as units began to outdate in the fourth week of October.

There's a lot that can be learned from our experience after September 11th. But in terms of monitoring, the real story isn't here. It's here. But we'll never know what might have happened next.

The third and perhaps most important facet of the NBDRC scheme is forecasting. Forecasting is a powerful tool that's used both in for-profit and not-for-profit sectors. Over the course of the past year, we've been trained to apply forecasting methods to the monthly blood data that we have collected by Dr. Barry Keating, a professor of business economics at the University of Notre Dame, and I'll show you some examples.

Here's a collection forecast for our entire sample group. The blue line is actual data through July. The red line is the forecast. The green lines are the lower and the upper confidence intervals--confidence limits, excuse me.

The confidence limits here are relatively narrow, indicating a fair degree of accuracy of the forecast. It was generated from a time series of decent length, good density, meaning at least monthly data, and repeating patterns, and using data from a large collaborative group, the monthly sample of 25 blood centers, as opposed to a single center.

Here's an inventory forecast for the group. Note that the narrow confidence intervals indicate that this is a very accurate forecast for the third week of August 2002 through January--first Wednesday of January 2003. And also note that the confidence intervals tend to widen as you go further out in time, which is typical.

If I had a forecast for my individual blood center, I could increase the accuracy of my forecast by overlaying the forecast for the group onto my forecast line so as to overlay the patterns, and this is called grouping. And although I'm not showing you the effect of grouping, we do prepare forecasts for each of the individual blood centers in our monthly sample, and they're forecasts specifically for those centers individuals, but they benefit from the collaborative experience of the whole group.

And, finally, a forecast of distribution which is probably the best variable that we have in terms of forecasting. We use smoothing techniques to adjust the actual data that allow us to retain the repeating patterns or seasonality of the data while getting rid of the noise, the other fluctuations that we want to eliminate.

The accuracy of any forecast is greatly improved by these things, these factors: increasing the density of the data set or the frequency of data points; grouping, a collaborative forecasting model is much, much more powerful than if each unit does a forecast itself; smoothing, retaining the inherent patterns in blood data while eliminating the noise; event modeling. We used event modeling very heavily to deal with the post-9/11 data so that it wouldn't have a disproportionate effect on our forecasts for 2003--for 2002, excuse me.

And, finally, don't stop or interrupt data collection. The longer the time series, the more accurate the forecast becomes.

I'm certainly not suggesting that the National Blood Data Resource Center is the first organization in the blood community to apply forecasting techniques to the blood supply and to supply management. Many of you here are using forecasting very successfully in your own institutions, but what I am suggesting is that the accuracy and the value of these forecasts could be greatly increased by a collaborative system.

We believe that a monitoring scheme should be quantitative and should include forecasting. A scheme that ignores the value of forecasting is like turning on the weather report and hearing that earlier this morning it was very cold or pleasantly warm and nothing more.

There's one final aspect to forecasting--and in this case it's probably more accurately referred to as a projection rather than a forecast--that I'd like to tell you about before closing.

One additional group of studies at the NBDRC is helping us to gain a better understanding of how blood components are currently being used in the United States and the drivers behind the increase--the continuing increase in demand. These detailed analyses of utilization by DRGs and patient demographics that we're conducting are funding by the National Blood Foundation. We now know from these utilization studies that 50 percent of transfusion procedures are performed on patients 69 years of age and older, and this comes from Jim Greer's analysis of three years' worth of data from the national inpatient sample.

This slide, which was created from Census Bureau data--and my apologies to the Bureau for neglecting to put that on the slide--illustrates the age distribution of the U.S. population in 2000. At that time, and today, there are approximately 27 million residents, or 9.9 percent of the population, that fall in the range from 69 years of age upward. By 2020, as the baby boomers break into the upper age brackets, an obvious shift will have taken place in the age structure of the United States, resulting in an additional 12 million residents in these upper age groups. And at that point they will represent 12.1 percent of the U.S. resident population.

At the NBDRC we are analyzing population demographics as well as trends in the use of specific blood-intensive procedures in an attempt to provide a more accurate demand planning model for the coming years.

So, in conclusion, I have two sets of conclusions. What I call the database conclusions, we know that total collections in 2001 exceeded 15 million units; that more patients' surgeries were affected by blood inventory shortages in 2001 than in 1999; that distribution increased significantly in 2001 in comparison to 2000; that this year collection and inventory totals thus far are unchanged in comparison with last year pre-September 11th; and that by 2020, 12 million residents will be added to the age groups at highest risk of transfusion.

My second conclusion is what I call my "obvious to us" conclusion, and this is that an accurate working understanding of the dynamics of blood supply and demand can best be achieved by detailed characterization of blood services over the long term, frequent quantitative monitoring of representative hospitals and blood centers, and creation of a collaborative demand planning model or forecast.

I'd like to acknowledge individuals at the NBDRC, our paid and volunteer consultants, and the blood center participants who have contributed to the work I've presented today.

Thank you very much.

DR. BRECHER: Okay. Thank you, Marian. We're already running a little behind. We maybe have time for one question or comment.

[No response.]

DR. BRECHER: If not, let's move forward, and we now have Peter Page from the American Red Cross.

[Pause.]

DR. BRECHER: While they're setting up, I'll just let the committee know that several committee members will not be able to stay until the end of the day, and there was a request to discuss the reimbursement resolution. And we are going to do that after Peter Page's talk.

MR. PAGE: American Red Cross very much appreciates the opportunity to share some of our data and looks forward to questions or interactions.

In the morning remarks, I will talk about monitoring red cell inventory, and the first several slides are some background about American Red Cross.

The upper two curves are how many units of whole blood we actually collected versus what our collection plan was, and last fiscal year, we collected more than planned. That included September 11th. Current year to date, we're a bit behind year to date planned or recruitment goals. You can see that we've been collecting more every year.

The lower curves are our actual number of red cells distributed and our projected or forecasted distribution or budget plan. I think you can see that for the last five years we under-projected. We distributed more than we had planned for, and that number also has been going up every year. The gap has to do with test positive units, outdates, other losses.

American Red Cross as a system works through its 36 regions. The geography traditionally served by each is reflected in a different color on this map, and our regional code number is shown there.

These 36 regions we divide into four areas of the country. On the left is the Northeast, then the Midwest, then the Southeast, and then the West, generally, not identical but similar to the areas described by earlier speakers.

Each regional code has two columns. In the foreground is their collections of whole blood for last year, and in the background is their red cell distributions in the last year. You will see that some regions distribute much more than they collect, while other regions collect more than they distribute. And by Red Cross being a system, we use this data to equalize equitably the adequacy of our blood components through the country.

Lumping each of the four areas of the country, I think you'll see that the Midwest collects more than it distributes more than the others and that the Northeast collects about what it distributes, which does not acknowledge losses and outdates. So the Northeast is dependent upon the other three quadrants of the country, particularly the Midwest and the Upper Midwest, in providing blood supply throughout our Red Cross system of 36 regions.

Our inventory management is comprised of three components. One is planning the balance between the units we collect in each region and the units distributed in each region, and we do that balance for the whole system, and I'll talk about that.

The second component is managing the units in our inventory systemwide, and the third I wasn't planning on talking about here and don't have slides to represent, but it's the local-regional management of its inventory and delivering blood to the hospitals it traditionally serves.

First, planning the balance between collection and distribution. As a system, every quarter we determine the 18-month and the future system demand forecast based upon projections from each of our 36 regions, which we then cumulate and think about other factors that we think might influence it.

We analyze those projected requirements with our current collection capacity to determine whether we have an excess or a deficit in collection capacity. And then we align the capacity with our projected requirements.

We then balance the system amongst the 36 regions. Import and export contracts among our regions we call internal distribution as opposed to what I'll call later on external distribution, which is distribution to a hospital or to the two blood centers in New York City.

Every quarter we measure our most recent plan versus actual, determine whether we can the causes of differences. We review with that in mind our forecast assumptions, and then we determine the impact of our actual performance and assumption changes on the 18-month plan. And then we make modifications in our planning, our collection goals, our staffing levels, our import-export contracts, as deemed appropriate on a monthly basis.

Now, every day we manage the units in our inventory across all 36 regions. We put in today's inventory and, as with others, it's on the quiet hours of the midnight shift. We have our daily forecasted blood collections for each region and the projected distribution for each day into a two-week forecasting model.

We compare the forecasted inventory levels with the required inventory levels for the next two weeks, and then we determine the excess and needs among all 36 regions. We internally--and I'll give you examples of this. We internally distribute components among the regions to cover the required inventory levels outside, not including the import-export contracts that are annual ones among the Red Cross region. And then for each of the four geographic areas, we have an inventory planner who has a conference call with all the regions in his area every day to validate the forecast assumptions and identify emergencies or other issues.

Then later on in the day, the national inventory manager, Leo DeBande (ph), who's responsible for much of the work in this presentation, coordinates among the four area inventory planners.

Now, we have used some standard definitions, and we are in the process of considering different ones, but this is what we've used. A one-day supply is based upon a three-month rolling average of gross daily hospital distributions plus the region's average daily export contract to other Red Cross regions, as well as the over 100,000 units a year that we're shipping to New York City.

We consider a two-day supply a critical inventory level, and an adequate inventory level to be a three-day supply, and that's in our regional inventory. It does not include what's in hospitals. An optimal we have considered seven days.

So, for example, a one-day supply of red cells, all ABO types, would be 25,000, and I think you can read for yourself the other numbers, remembering that that's for all types, which I'll talk about this afternoon.

A couple days ago, August 30th, we had 51,000 red cells in inventory, so we were just at a two-day supply.

Here's a sample of how we forecast the red cell inventory, and this is true data, and it is for one region. What we do is we take the daily inventory in the wee hours of the morning. We add to the forecasted daily release, which means the number of units that we forecast to collect that would be released two days later after test results are back, labeling has occurred, and they're ready to be released for distribution. That's projected every day. And then we subtract the forecasted daily distribution based upon the local region's traditional hospital needs and export contracts.

So we have just a week of data here from the middle of July. It's divided out for that region by ABO types and then totaled. So that's the forecasted inventory for that region.

Then we try and determine whether there's an excess or a need in each region, and so this is the same region for the same dates divided by type, and the blue numbers indicate that we project an excess in A pos., and the red numbers indicate that we project for several days a deficit in O pos., most days O neg. and A neg., and a little bit of problem with some Bs as well.

So then we take these excesses and ship them into places where there are needs on a daily basis to equilibrate our needs throughout the system, and that's basically how we monitor and manage our inventory. I was going to stop there because the remaining slides have to do with how much is enough for the optimal inventory.

DR. BRECHER: Okay. Thank you, Peter.

Are there questions or comments?

[No response.]

DR. BRECHER: If not, Chris Healey has yielded his time so we could have a discussion about the reimbursement resolution, so, Dana, do you want to propose the resolution?

DR. KUHN: We had physically sent out the resolution to be typed up, hoping that we would have it for the committee at this time. It might be still in the process.

DR. BRECHER: Why don't you just read it for now. Then maybe we can get it projected on the screen, if someone could type it in.

DR. KUHN: Let me just say thank you for yielding some of this time, Mr. Chairman, so that we can address this all important topic and prospective ruling that may come out.

The recommendation, I think, when we get it will have this kind of concept behind it: that we're going to recommend that the Advisory Committee on Blood Safety and Availability recommend that the Secretary of Health and Human Services direct the Centers for Medicare & Medicaid Services, the CMS, that all plasma-derived and recombinant analog therapies be reimbursed at a present reasonable cost and that payment for these plasma therapies be tied to payment policies for--and we're looking for a better word than this, but drugs provided in the physician's office and other non-inpatient settings to ensure access to care, ample availability, and uninterrupted life-sustaining therapy.

That is the gist of the recommendation, and it does have a whereas clause, which would provide the justification and probably provide the focus for the recommendation itself.

If you would allow me to read that, and then hopefully we can get copies to each committee member:

Whereas, fair payment to hospitals for blood, blood products, transfusion services, and transfusion laboratory procedures is essential to ensure that Medicare patients have access to the best possible care, the Advisory Committee urges the Secretary of Health and Human Services to direct the Centers for Medicare & Medicaid Services, CMS, to establish 2003 Medicare Hospital Outpatient Prospective Payment System payment rates for blood and blood products, transfusion services, and transfusion laboratory procedures based on current year costs rather than on hospital outpatient claims from previous years;

Whereas, the plasma-based therapies and their recombinant analogs are: one, life-sustaining or life-saving treatments; two, predominantly treating rate disorders, thereby making hospital claims data an inadequate basis for cost analysis; three, administered for chronic conditions, therefore, requiring hospitals to stock significant supplies; and, four, administered in a hospital outpatient setting at the recommendation of health care providers;

The Advisory Committee recommends that the Secretary of Health and Human Services direct the Centers for Medicare & Medicaid Services, CMS, that all plasma-derived and recombinant analog therapies be reimbursed at appropriate levels to safeguard patient access to these critical therapies because the Hospital Outpatient Prospective Payment System, HOPPS, no longer provides for adequate reimbursement of these life-saving therapies, the committee recommends that payment for plasma therapies should be tied to payment policy for drugs provided in the physician office and other non-inpatient settings to ensure patient access to care.

DR. BRECHER: Comments? Karen?

MS. LIPTON: I just wanted to say, we had tried to combine both the blood and the plasma resolutions, and they didn't quite work because they operate a little bit differently, so there's a separate one also for blood, which--are you trying to pull that up, Theresa?

MS. WIEGMANN: Yes, I am trying to.

MS. LIPTON: Okay. And do we have copies of this other one for the committee?

[Inaudible comment off microphone.]

MS. LIPTON: I think they had to copy it downstairs, and it's on its way up.

DR. BRECHER: Okay. Karen, do you think we could combine the two, or should we keep them separate?

MS. LIPTON: I think at this point, because of the way that they are reimbursed, that it would be easier to keep them separate. They are both the same sense. It's just that from a technical standpoint they operate a little bit differently.

DR. BRECHER: Okay. Comments? Suggestions?

MS. WIEGMANN: Do you want me to make that larger?

DR. BRECHER: Okay.

DR. EPSTEIN: I just want to ask Dana and others: At the present time, the problem is that there's a misalignment between the proposed prospective payment for in-hospital versus outpatient, where the real cost in the outpatient is obviously much higher. But will that recommendation stand the test of time? In other words, the real cost in-hospital could at some point between greater than outpatient. So is that really the standard you want to put in place, or should we put some caveat under the current circumstance?

DR. KUHN: So if I understand you correctly, Jay, you're looking for, you know, what--the what if's occur, a correction to what has preceded this ruling, in other words, the way they've done this ruling now, in other words, we'd like to try to correct it in the future so it doesn't come to this kind of a point.

DR. EPSTEIN: What I'm saying is the recommendation is framed as a change in the decisional criterion for prospective payment. And what you're asking for is a decisional criterion based on outpatient real costs. Okay?

But outpatient real costs may not be the right metric in the future. So if you get CMS to change its underlying criterion, true, you fix the immediate problem, but you may not be happy with what you've got in the future.

DR. KUHN: Right. I think that's why we had used--I'm not sure, but I think that's why we used the word that they should pursue cost basis. You know, that would be in and out, in-hospital and outpatient.

DR. EPSTEIN: I would say considering both real costs in-hospital and in outpatient settings rather than making a recommendation that strictly links it to the outpatient setting.

DR. WINKELSTEIN: I agree.

DR. KUHN: That's okay.

DR. WINKELSTEIN: It's a minor but important modification. Jay is trying to not have us have a restrictive recommendation, one that's more flexible and can move with the future. So it sounds like a no-brainer.

MS. WIEGMANN: And so what you're talking about, just the plasma-based--the plasma derivatives at this point in time, is my understanding.

MS. LIPTON: The one that's up there.

MS. WIEGMANN: Well, no, they're both up there. The first two paragraphs are about referring to blood and transfusion services. The second after the little bulleted section, from that period on are the plasma derivatives. I can put them on separate pages or...

MS. LIPTON: I guess my concern with just using current year costs is I still am convinced that they confuse costs and charges, and I would like to see acquisition costs because I'm just concerned that when they look at a charge they say, well, we did base it on a cost. And the question is: What did the hospital have to get it for, not what--not what does CMS think that they are paying for it. I mean, one person's charge is another person's cost.

DR. HOOTS: I think that's important because acquisition costs, particularly in the plasma and recombinant analogs, is so dependent on the specific product and who's buying it. And obviously the Federal Government, ever since they started prospective payment, has had access to acquisition cost data that is local, that is definitive for an individual purchase. And that's what they need to use because that's--it's going to vary somewhat regionally. It's going to vary dramatically on the type-specific product, and it's also going to vary based on the amount you buy. So acquisition cost seems to be the line at which you should draw whatever purchase plus cost of distribution is added onto. But acquisition cost should be the one, not anything to do with the amount that was either budgeted for or any other point.

DR. BRECHER: How about the word "drugs" at the bottom? Is that the appropriate word, or is there some better word?

MS. LIPTON: I thought perhaps they might use "for such plasma-derived and recombinant analog therapies." Then you don't get trapped into is it a drug or not a drug, you just reference the--

DR. BRECHER: Or just simply "for such therapy"?

MS. LIPTON: Yes.

MS. WIEGMANN: One comment back on the acquisition issue, Karen, and the rest of the committee. We used the word for the cost as the cost to the hospitals, and in that paragraph we're not only referring to the cost of the blood products but for the transfusion services, so acquisition is not necessarily an appropriate term there.

MS. LIPTON: Can you think of one that would be that wouldn't allow them to substitute charges or claims for cost?

DR. LOPES: How about acquisition and provision costs?

DR. BRECHER: Or acquisition and/or actual cost.

MS. WIEGMANN: Actual total costs?

DR. HOOTS: If we want to be inclusive, we can include in parenthetical form what we mean by actual, including inventory costs, distribution costs, et cetera. I mean, just "et cetera," but not all-inclusive, but at least that it's in there so that it doesn't get written in stone that they'll only reimburse acquisition, ignoring all the other necessary costs for getting it to the end user.

MS. WIEGMANN: We also added the clause after that with the "rather than hospital outpatient claims," and that gets somewhat at your concern about charge data versus cost data.

MS. LIPTON: But I think that the specific point there was that there is a cost of acquiring the product and then there's a cost of providing the therapy that's related to the product.

MS. WIEGMANN: Okay.

MS. LIPTON: And so the cost needs to encompass both of those pieces, not just a, quote, product cost. Is what you're getting at, Keith?

DR. HOOTS: Yes.

MS. WIEGMANN: So if I put there acquisition or actual total costs of providing such products and services?

DR. BRECHER: Right, that should cover it, I think. Jeanne?

DR. LINDEN: I just have a question on what's included, because the first item includes blood components and derivatives, and then the second one is the plasma derivatives only, but it sounds like you're intending the first to be components. If you can please clarify the intent?

MS. LIPTON: Yes, it's confusing.

MS. WIEGMANN: I'm sorry. Can you repeat your question?

MS. LIPTON: I think the question is blood or blood products seems as if it also includes the plasma-derive and analog therapies, and I think what Jeanne's questioning is: Isn't the first one really just related to what we would call traditionally blood and blood products--

MS. WIEGMANN: Components, yes.

MS. LIPTON: --as opposed to plasma-derived products.

MS. WIEGMANN: Yes.

DR. BRECHER: Dana?

DR. KUHN: Mr. Chairman, did we incorporate Jay's concern about when we do the analyzing the cost that we include in-hospital as well as outpatient?

DR. BRECHER: Jay?

DR. EPSTEIN: Well, I think that in the first recommendation it's fine, and in the second recommendation it's too narrow.

DR. BRECHER: Jay, do you have some alternate wording?

DR. EPSTEIN: I would word the last sentence of the last paragraph similarly to the last sentence of the first paragraph.

MS. O'DAY: I think that's an excellent recommendation, let's put it in.

DR. KUHN: And just in case someone may question this committee, you know, maybe terminology, access to care, I think that should stay there, but I think we also should add in "and availability" after the bottom, at that bottom sentence. This is an availability issue.

DR. SLATER: Yes, but that's not going to be able to be changed on a dime. CMS--I think it's a logical suggestion, but it's an impracticable one. The prices can't change in a free-flowing fashion.

MS. O'DAY: I'm sorry, Dr. Epstein. We got confused here. I thought your recommendation was that in the plasma-based therapies, right now the way that the recommendation is structured it speaks to AWP, which may be altered at some point, and you were expanding it to a reasonable cost basis, and you had some expanded language. And we just confused about where you wanted to make the changes.

DR. EPSTEIN: My proposal is that the last sentence parallel the language of the second paragraph; in other words, that payment for plasma therapies should be based on current year acquisition or total costs of providing such products and services. And you could then also say both in inpatient and non-inpatient settings.

MS. O'DAY: Gotcha.

DR. EPSTEIN: I would also suggest that part of the sentence that says "because the Hospital Outpatient Prospective Payment System no longer provides for adequate reimbursement of these life-saving therapies," that's actually, if you will, a finding of fact. And I think it belongs up in the bullets where you have "whereas." Maybe you need a second "whereas." In other words, "Whereas, plasma-based therapies and recombinant analogs are life-sustained," et cetera, and I think you need to say "And, whereas, the current Hospital Outpatient Prospective Payment System no longer provides for adequate reimbursement," because that's not really a recommendation. You're stating what you think to be a finding or a fact.

[Pause.]

DR. EPSTEIN: Right, and just change the "because" to "whereas," and then move it up as a second "whereas" statement. No, under the last bullet. Change the "because" to "whereas," and make it its own paragraph.

[Pause.]

DR. EPSTEIN: Yes, and you could just say "And, whereas."

All right. And it's been pointed out that the first sentence of the last paragraph is actually redundant with other text. You could simply move to, "The Advisory Committee recommends." And just strike everything down to the words "that payment" in the next to the last line.

[Pause.]

DR. EPSTEIN: Right, and then the text is that it should be--right, based on or tied to current year acquisition--right--for such therapies.

DR. WINKELSTEIN: Jay, do you want to say "acquisition and actual total cost" rather than "acquisition or total cost"?

DR. EPSTEIN: Yes, I think it should say the same thing that it says in the above paragraph, make the "or" the "and."

DR. WINKELSTEIN: They both say "or"--

DR. EPSTEIN: I think it should say "and" in both places. And it should say "The acquisition cost of providing such products and services," and then we want it to say "both within hospital and in non-inpatient settings."

MS. WIEGMANN: Not necessarily for blood--blood is a little--

DR. EPSTEIN: Well, now, I thought we'd separated--

MS. WIEGMANN: -- hospital.

DR. EPSTEIN: I'm sorry, but I thought the entire second section is plasma therapy.

MS. WIEGMANN: Okay, yes. Down here, I'm sorry.

DR. EPSTEIN: Right. After the words "and services." It should say "both within hospitals and in non-inpatient settings."

All right. That's period, and the rest comes after. And you could add the words "both within hospitals and in non-inpatient settings," period. Now, if you want to illuminate it by saying "such as" or "including physician offices," that's redundant, but it makes a useful point, perhaps. I would just say "including."

[Pause.]

DR. EPSTEIN: Could I ask a technical question? We've struck the words "The Advisory Committee recommends that the Secretary of Health and Human Services directs CMS," et cetera. Are we better off leaving those words back in or leaving those words back out? They're in the first recommendation in the second paragraph. They're no longer in the second recommendation.

DR. BRECHER: I think we should be consistent, put them in the second paragraph.

DR. EPSTEIN: Put those words back in.

DR. BRECHER: As long as we're up there, is "urge" the right word, or is it "recommend"?

MS. WIEGMANN: Recommends, yes.

DR. BRECHER: "Urge" is sort like a little nudge.

DR. EPSTEIN: "Recommends that..." Right. And then we want to add those words back in the last paragraph.

DR. BRECHER: If you just put your cursor at the first letter, hold the shift key down, and then with your arrow key go over, you'll highlight everything.

COLONEL FITZPATRICK: Is "ensure" the right...

DR. EPSTEIN: Where's "ensure"?

COLONEL FITZPATRICK: "Ensure patients access to"--

DR. EPSTEIN: No. That should come out.

MS. LIPTON: And then you just might want to delete the "should"; instead of "should be tied," just "be tied," "recommends that it be tied..."

DR. EPSTEIN: "Be tied," right. "Tied" or "based"? We used "based" above.

MS. WIEGMANN: "Based."

DR. EPSTEIN: It should say "based" again for consistency, "based on."

DR. KUHN: In that paragraph we used the phrase "plasma therapies" and in the first "whereas," we say plasma-based therapies and their recombinant analogs." Should we pick up that full phrase down below?

DR. EPSTEIN: Yes.

[Pause.]

DR. EPSTEIN: And should it say "plasma-derived therapies"? Because "plasma-based therapies" could be understood to include components, fresh frozen plasma, cryopur plasma, et cetera, cryoprecipitate.

Then you want to change that in the last paragraph.

MS. WIEGMANN: The other--

DR. EPSTEIN: Yeah.

DR. BRECHER: Okay. Is everybody happy with this wording? We'll take a vote--

DR. DAVEY: Mark, just one quick question. Just to make sure people are clear that we have two clear recommendations, I would just suggest a 1 and a 2, a 1 right there and then 2 at the next "whereas."

DR. BRECHER: Okay. Given that we now have them numbered, voting members, I'd say all--all in favor of the numbered version?

DR. KUHN: No--

DR. EPSTEIN: No, Miriam, I think the number 2 belongs two paragraphs up at the word "whereas."

DR. KUHN: Yes.

DR. EPSTEIN: Yes.

DR. KUHN: Right.

DR. BRECHER: Jeanne?

DR. LINDEN: I thought we were going to with "blood components" in the first one?

DR. KUHN: "Of blood and blood products."

DR. LINDEN: You're not including plasma derivatives?

DR. KUHN: Right. We need to be consistent with the two paragraphs. I'd say "components" rather than "products."

DR. LINDEN: But the very first line should be "blood and blood components."

DR. KUHN: "Blood/blood components."

DR. LINDEN: If we're limiting it to--

MS. WIEGMANN: Yes. Sorry.

DR. BRECHER: Okay. Now we're going to vote. Voting members in favor of these two resolutions? It looks like we have a majority. Those opposed?

Okay. These two resolutions carry. Thank you.

We'll now move on to the last agenda item for the morning, which is a discussion of forecasting by Dan McGee from Florida State University.

[Pause.]

DR. BRECHER: Sorry. I've gone out of order. Forecasting is after lunch. We're going to do lessons from the--

MR. : She's not here yet.

DR. BRECHER: Oh, she's not here? So let's do forecasting. Back to forecasting.

MS. WIEGMANN: It's not working.

MS. O'DAY: We'll just unplug it.

[Pause.]

MR. McGEE: I apologize for not being set up. I thought I was going after lunch.

While this is heating up, I'll say that I'm generally in the same position as most of you on you have no data. My involvement here is simply that I serve on the FDA's BPAC. When they keep getting faster, I wonder why these seem slower.

[Pause.]

MR. McGEE: What I find is whenever I start with some thoughts, it means I'm really still formulating thoughts. And it was very helpful listening this morning to all the presentations, so I'd like to start with a contrast, I think.

There were three words I heard this morning a lot: "collaboration," "commitment," and "intervention." And I started in the world as a biostatistician at the National Heart, Lung, and Blood Institute. In 1948, the question of chronic diseases was becoming rather--to the forefront in the United States, and the fledgling NIH made a rather phenomenal commitment of 20-some years to study heart disease in a little community in Massachusetts called Framingham.

That, I think, is unparalleled in the government, but not only did they commit to that 20-odd years, they committed to a collaborative project. When I went to work at the National Heart, Lung, and Blood Institute, there were eight full-time statisticians who did nothing but think about how to analyze the Framingham data and to analyze it. But they didn't do this in isolation. They did it in collaboration with some very fine cardiologists, laboratory types, and epidemiologists. So there is a precedent for this type of thing. It is different times.

As I said, I had no data. I was given the same data as you, which were these time trends, very pretty pictures. And what we're talking about and what I'm going to just say a few words about--and, by the way, I'm going to--I think given the last presentation and the ones I've heard, I'll try to cut it a little short because I'm a bit redundant. I'll make the same points that they did, but perhaps with different data.

And so a time series, we all know what it is. It's just we have data over time--that's the x axis--and we have some measurement of something, the total red blood cells is the y axis. And this is from the 26 sentinel hospitals that were talked about earlier. I just scanned these in from the hard copies I was given.

So the first thing that a time series can do for us is just plain description. I'm not going to say much about it because I would really echo what Dr. Fitzpatrick said this morning, that without some way to think at least about intervention--and I forgot to mention that the Framingham study, if you think about it, led to some of the major interventions that took place in this country. The findings on cholesterol, the findings of blood pressure and so on led to major clinical trials that came to an outcome.

The second thing is monitoring, and monitoring--again, it's not sufficient just to monitor. What comes to mind is that we're looking for something unusual that occurs. The thing that comes to mind with me is always laboratory quality control. I spent my youth monitoring a laboratory and once spent two months of my life finding out that the laboratory director was putting the wrong dates on his quality control samples.

Nonetheless, the point is that the monitoring was used to show me an unusual event, which was it appeared that the laboratory was out of control, and to go looking for and then to see if it could be fixed. So I think it's not sufficient to say, well, we have four clinics or four blood centers where a shortage is. The question is: Why did the shortages occur, and can we fix them?

Forecasting, you just heard a nice introduction to forecasting. I'll say a little bit about it. What we want to do, let's be honest, we want to predict the future based on the past. We don't say we want to predict because if I went around telling people that I want to predict the future, they would give me strange looks and not believe me. But if I say forecasting, it has a little milder tone and something we have to do.

Something I didn't see mentioned this morning was these time series help us in looking at what if's. What if the entire State of Florida suddenly its blood supply ended? What could the nation do and how could it be treated?

There are three things. Everybody's talked about them. The first one that is being batted around is the questions, and it seems to me that all of these data are--some are answering similar questions, a lot are answering different questions.

I happen to like this sentinel system that you folks have derived. But it answers one question, I think, which is: What is the overall blood supply in the nation? The data itself, you would have to answer that, and then we--I'm going to say a few words about models, not much.

These were the data that were supplied to me. The first--and you heard about them this morning, so I don't need to really go over them. And the first question I would ask with these data is: If these folks could collaborate, is it possible to combine these multiple sources of data and get a better projection or a forecast?

The source of the data people went over. I still have, at least in my mind, some questions about the quality of the data ongoing. It seems to vary--not the 26 sentinel hospitals. Those seem set. But some of the data seems to be what I would call a convenience sample, and the question is how representative it is.

The next question is timeliness. How timely really is the data, and how timely should it be? And if I put that back in, I apologize. I wasn't prepared so I didn't put a mouse up here. I'm terrified of trying to get the mouse pointed with one of these text pads.

But a good example is on this data, which is if you look--it was mentioned when it was shown. It was quite open, which is that final drop at the bottom says that the data really are not quite up to date. They're about a week behind in anything. And is that good enough? Perhaps.

Okay. This modeling of the data, you know, any--you can ask six statisticians, and they'll give you six different models, and all will be pretty good. But I want to differentiate between data dependent in context and process-driven modeling. And it's very important in time series.

About, oh, eight, ten years ago, I was at a different university at the medical school during the time of changeover to managed care. And we were going to from a tertiary care center to a primary care center, and I got a call from the provost one morning saying they'd hired a business consultant to predict clinical income from all of the departments, and then, I guess, rewards and punishments were going to be developed based on these projected clinical revenues. And as you can all imagine, the clinical department heads were having a fit over this, and they asked me, I guess, to bless these projections.

So I met with the young fellow who had done the projections, and he had done really nice mathematics. He had used the best software available. But in one particular department, what had happened, because of this changeover there had been a large loss of personnel. So it was a very short period in which clinical revenues were very low. Then they began to rise, and then there was a short period when they tapered off. He had, in fact, fit a trend that showed a very rather large increase going on in the time.

Now, my point is that he did violate an assumption of time series, which is stationarity, which is that we can't--it shouldn't matter where we sample the data. We should get the same picture. And we'll get back to that. If I have the right slide in here, we'll get back to that in a moment. So he forgot that.

But had he simply talked to the people in the departments, he would have known all this, and the question of seasonality that was talked about in the previous talk is something that has to be done with subject matter people. It cannot--I can find them for you. Believe me, if you give me a set of data, I'll get you a model. But the question is whether it's going to be correct.

So my point that I was making here is simply that this has to be a collaborative thing. So I did put that slide in. And without a pointer, I'm going to just point to this, but any fool can look at that and see if I fit that red line, I'm going to project--oh. A laser, a little tiny laser. If I fit that line, I'm going to fit a tremendous decrease in the nation's blood supply based simply on that.

Context. Now, any fool knows this, but often we don't know that September the 11th went on.

So my point is that it takes more than just mathematical models. Somebody has to sit around and talk to subject matter people to figure out what's going on and what the important aspects--where are the important cycles in the data? Do they make sense? Do they not? And then perhaps can we intervene on them?

I don't want to waste a lot of time with this, but I'm very fond of this example because it shows both that we can do forecasts and that we can be arrogant in doing forecasts.

This is from a 1920 article in the National Academy of Sciences by two very famous men, Pearl and Reid. Pearl was a biostatistician. Those of you who know Johns Hopkins, the Reid-Frost Symposium is named after this Reid. And all they wanted to do is project the population of the United States. And they had data from 1790 up to 1910, and there are actually two points on this graph. One is their prediction and the other is the actual population.

And you can see it's pretty good. You have a hard time fitting those. That's the data itself. Okay? Let's see if I can make this change. Oh, and they went beyond just projecting the size of the population. What they were interested in was limiting population size for the United States.

They said that the maximum growth of the population occurred in 1914, and they said--they actually did go into context in great detail. It's a fascinating article if you ever want to read it, and they said something would have to happen that's never happened before to make this change. And they also calculated the limiting population of the United States. How big a population could the United States actually sustain? It was 197 million, roughly. And they went beyond this, though. I've shortened this here, but they actually calculated the number of calories that it would require to sustain this population, and then they went ahead and brought in all sorts of experts who said the United States could not conceivably produce that many calories.

So if you take their predictions, they really aren't bad for the population of the United States. This shows the population through 2000, and this is the actual population, and this is their predicted population. And you can see that up through around 1940, they actually did rather well. So the short term, you do very well, and this is pretty much the point that was made in one of the slides of the last talk, that as we go further away from where we are, the worse we can do. And the second thing is you cannot foresee these events or loadings.

In my own case, if I had any arrogance about my ability to forecast, as I was throwing my stuff in my overnight bag, my wife, Karen, picked that point to tell me about how well my retirement funds had done over the last year. I attempted to explain to her about events and loadings and things, but she explained to me that it meant that I'm going to be working for the foreseeable future.

So my point is it can be done, and all sorts of statisticians can do it, but we ought to take them with a grain of salt, and we have to be very careful. And, finally, I believe in what I call the shotgun approach. There are lots of ways to do these things. If they give you different answers, then it's hard to tell which one's right. If they all give you roughly the same answer, you're pretty good.

Now, the way--I have a son who lives in Puerto Rico, so I pay a lot of attention to hurricanes. What the Weather Bureau does is they have like a half a dozen competing models, and they fit all six competing models, and if they give them the same answer, they start getting people ready. And they have a weighting scheme for doing it.

That's about all I'm going to say. I thank you for the opportunity for saying it, and if you have any questions, I'm ready.

DR. BRECHER: Okay. Thank you.

I think we're going to just break for lunch now, come back at 12:35, 12:40, and we'll resume at that point.

[Whereupon, the meeting was recessed, to reconvene at 12:40 p.m., this same day.]

AFTERNOON SESSION

[12:42 p.m.]

DR. BRECHER: Okay. Everyone take their seats. We're going to begin.

Okay. If everyone will take their seats, we're going to resume. We're going to start the afternoon session with Mike Fitzpatrick talking about strategic reserves, liquid and frozen. You're on, Mike.

COLONEL FITZPATRICK: Okay. The good stuff comes at the end. It's a pleasure to be here after lunch. Hopefully I can keep everybody awake, and we'll go through this.

A lot of you have seen some of these slides before, but there is a different twist to the talk, and I'll go through the repetitive stuff quickly, I hope.

As you know, we have set up a worldwide distribution system in the military, and we're losing a little bit of the slide, but over here are all the donor centers in the United States. We have laboratories on the East and West Coasts that we ship the blood to, and then from there it goes to the overseas destinations or a blood transshipment center and eventually to the hospital.

It's been since 1953 when this was established, and the reason that we have frozen blood reserves is because, by our estimates and our planning, if there were a large war--not a small war but a large war--it would take us up to ten days to actually be shipping all the liquid blood to the theater that would be required to support the war on a regular basis, even though we know we could ship some blood in here, the three-, four-, and five-day level. And so it's essential for us to have some reserves.

Right now we have 21 donor centers within the United States to collect blood, and as I show you what we've been doing with these 21 donor centers, I hope you'll understand that the Department of Defense is supporting our nation fairly well right now.

Just to put it in perspective, back in October of last year, we implemented the variant CJD deferral as in the FDA guidance fully. We did not phase it, and we did it early in October because of implications with the Red Cross deferral policy.

Since 9/11, you can see, this is an estimate of the civilian blood inventory. It's not exact. We do get exact figures from the Red Cross, but we have to extrapolate some figures from America's Blood Centers because of their Stoplight program. But you can see that nationally we seem to be running at about a three-day supply of blood in the civilian sector, and this is before the total implementation of variant CJD deferrals, which will come next month.

You can see in the military supply we have remained constant, green, above what we consider our nine-day level, which allows us to have enough blood to meet all our transfusion requirements and ship blood in support of Operation Enduring Freedom.

We did this by procuring $2.1 million to hire recruiters and phlebotomists in order to offset the deferrals that we were going to incur. Our estimated deferral rate for variant CJD was 18 percent. Our actual rate varies from 5 to 40 percent, depending on the installation, the mean being about 15 percent. So our estimate was not too far off.

Now, this is just a shot of our blood transshipment centers. There's one at Fort Travis Air Force Base and one at McGuire Air Force Base, in New Jersey and California, and I'll come back to those at the end of the talk.

Each one of those centers can receive and distribute 7,200 units of blood daily, and they retype each unit in that process.

We ship it--that's a cargo--that's 3,600 units of blood going into an airplane. And we have been focused outside of the United States and have a large distribution system set up outside the United States, and we've had to put into place a distribution system in this area of the world, as you all are aware right now. And that's what a transshipment center looks like, just a place to store and receive blood and transship it. They do not retype the units. And we have one that we can put up under tents if we need to.

But the goal is to have the blood here and available to treat patients. This war is a little different, and you'll see at the end of the talk why it's a little different and why I'm going to talk about reserves and stockpiles.

We have shipped in the past year to several contingencies. The most noteworthy here is the embassy bombings and the USS Cole, and those are noteworthy because we were asked to ship blood rapidly from the United States to Africa. The first aircraft went out of Andrews Air Force Base two hours after we were notified.

Now, even here within the National Capital Region, in Washington, D.C., because of transportation, because of traffic, because of a lot of things, that first aircraft went out with 23 units of blood on it. Twenty-four hours later, we had 900 units of blood ready to go. But the immediate rapid response is the key element to saving lives. Twenty-four hours later, everybody that had hemorrhaged to death was gone. Blood was still needed for constructive surgery, for those things that go on after a stabilized patient is in the hospital, but that immediate need was not met by us. It was met in Africa by other elements, but not by us.

And that just recaps the blood support to Africa. It did--we were able to get a hundred units from the Baltimore-Chesapeake Red Cross within hours, not within two hours but within hours, to Andrews Air Force Base to be shipped. And as I said, the next day we had lots of blood at Andrews ready to go.

We also shipped blood from Germany and, as you know, the Germans and the French shipped blood.

I want to focus a little bit right here on Operation Enduring Freedom. Right now we're up to 15,000 units shipped since October in support of Operation Enduring Freedom. You can look at Bosnia. The total so far for Bosnia and Kosovo is only about 8,300 units. And that's cumulative since we began our operations there.

Of those 15,000 units, 800 have been transfused, not all to U.S. casualties, obviously, because we haven't had that many casualties. They've been used in coalition hospitals, host nation hospitals, and on board ships.

We have used frozen red cells in the theater because we keep frozen red cells on board our casualty-receiving ships, and at the beginning of the operation, there was not a distribution system for Afghanistan. So the first operational elements that went into Afghanistan were deployed from a ship and came back to the ship, and any casualties that were generated came back to those ships for treatment.

You can see here that we have no platelets shipped because, of course, we can't ship platelets. They're only good for five days, and you can't get them into the theater. So the only fallback we have to that is to collect whole blood from volunteers that have been previously tested, but essentially they're being given untested units at that point in time.

And just for a point of reference, for Desert Shield/Desert Storm, we shipped over 100,000 units and transfused about 2,000.

Right now we have 59,000 units of frozen blood throughout the world as a strategic reserve. It's supposed to be of short-notice or no-notice contingency. It's under the old open system with only 24-hour dating and 10-year shelf life, of which about 40 percent has reached its 10-year shelf life and is expired.

That's what a frozen blood product depot looks like, a big building with lots of hemanetic (ph) cell washers, lots of freezers, lots of supplies, takes a lot to maintain it and keep it operating.

We're modernizing the system with the new hemanetic system which will give us 14-day dating. We're doing validation studies and replacing the stock, and we have an application in to FDA to extend the storage period from 10 years to 22 years. But there are some issues with that. As you get longer shelf life, you have to deal with future test requirements. How do you predict what sample you have on hand to test when you don't know what the test is going to be?

We also have the issue of current history screening. In order to maintain licensure, we've had discussions with FDA, and one of the feelings is that blood that's transfused as a licensed product should meet licensed requirements, which would mean medical history screening of the donor should be current.

It's an expensive program. To replace it we're looking at $33.7 million over 7 to 10 years.

Can it be a blood reserve? It can, but is it good at it? It takes one hour per unit per machine. It's not a rapid solution. It's expensive. It requires training. You need stock rotation and management to stay current with GMP issues. Compliance is always a problem because of handling and tracking frozen specimens, the medical history problem, freezers go down. Compliance is an issue.

But frozen blood, I think, can have a place as a frozen reserve, but maybe not the way we have done it over the past 20 years. I think the concept needs to change.

It can be used to provide the inventory during critical shortage periods, especially now that it has 14-day dating. If you have a shortage of Os at your facility and you have a freezer with 200 Os in it, it seems like a good idea to thaw them out and use them.

If we had enough liquid red cells somewhere in the country, then we could immediately ship them and rapidly respond to a situation, but as a result of that, we reduce the inventory below critical levels at some sites, if there was frozen blood available and you were having trouble collecting or testing or getting donors, you could thaw and deglycerize the frozen blood to backfill the liquid units that had been shipped to the site.

Along those lines, we're staffing a letter to the Interorganizational Task Force proposing a national reserve of liquid red cells. I'd like to be able to tell you the letter had been received by Mr. Doddridge at this point, but it hasn't because it has to go through a staffing process.

In support of that, you may not be aware--or you may be aware--that House Resolution, House bill 3448, Section 121 on homeland defense, calls for a strategic national stockpile, an authorized national stockpile of drugs, vaccines, biological products, medical devices, and supplies. I think Dr. Epstein might agree with me that blood is a biological product, so I think we could put it under House Resolution 3448, although I'm not sure that Congress had that intent when they wrote that bill.

But you have to have a plan to maintain a blood reserve. It would have to be located somewhere for rapid response. We have two sites, but two sites are probably not enough. And it could be collocate with frozen blood stockpiles or not, depending on this concept of operation.

There are a number of ways to look at this. What we're asking the Interorganizational Task Force to do is put together a work group of subject matter experts and see if it's possible. You could select sites to maintain three to five days over the normal minimal needs. You could actually transfer units to holding sites. You could develop a "virtual network," but the problem is as you expand the number of sites that support a national reserve, rapid response becomes more problematic. You need more transports. You need to be able to get it to the airport, and what if the aircraft are grounded again? Then you have to get military transport or permission to fly.

The more places you have to do that from, the more complicated it becomes. But the reason to have it rapid, again, is that the first flight to Africa left in two hours, and we only got 23 units of blood on it. I don't think that was quote as a success.

So the questions we need to answer are: Where? How much? How much money is it going to cost? And who manages it? How do we manage it?

I think we use the interagency task force and the agencies that are here to answer those questions or see if it's feasible. But from that we could have a national donor recruitment program. We could go beyond the problems we've seen with national programs in the past. If we have a national program, who do we tell the donor to donate to if the city has both an ABC center and a Red Cross center? Well, do we really care? Don't we want the donor to donate? That's the point. So if we have a national program to support a national reserve, we just tell them to donate. They select who they donate to. We shouldn't be competing over that.

We have subject matter experts to develop a work group and see if we can do this if there's a management structure and a plan that we can use to figure out an efficient way of doing it.

It would give us the capability to immediately respond anywhere in the world. It might allow us to help level those peaks and valleys because conceivably, if you have a national reserve, we don't have hostilities going on, but we have a critical shortage somewhere, you could cut into that national reserve to offset some of that critical shortage, and then build it back by coming back to your donor base and telling them we need your donation.

It might help restore donor confidence in the ability of our community--and I include myself in the blood collection community--to manage the gift they give us, because right now I think that confidence kind of ebbs and flows. No pun intended.

What would that do for me? It would allow me to move this number from ten days, I hope, back to the three- to five-day category. And if I could move that number back to the three- to five-day category, being very selfish and working for DOD at this point, I could reduce that number of 59,000 units of frozen red cells drastically and save you, the taxpayer, a lot of money, and myself, I hope. So that's a selfish motivation there.

What do we want totally? We would like to be able to treat casualties in the field with everything that we could to save their lives. So the first responder, we should be able to manage their bleeding. We should be able to resuscitate them with some product. And when they get to a hospital, they should be able to have plasma, platelets, and red cells to control their bleeding and resuscitate them. I can't do that in all instances right now. I have no capability to do that.

How does that impact on homeland defense? Well, we had this big spike after 9/11, and we outdated some units, and we've had some controversy over that. But that seems to have calmed down. And I think some good has come out. The Interorganizational Task Force--and Karen updated you on that, so I don't need to, but they've done good things, and they're making progress. And I'm glad that we're a part of that group.

We agree with them. We should avoid creating supply in excess of need. That's not easy to do, and I think they're working toward that goal.

This is a key element here, though, but even after 9/11, the civilian supply keeps dropping, and we need to do something about that. Whether that's an oxygen therapeutic, as you heard might be licensed in three to five years, or a liquid national blood reserve or a combination of those and other new products, we need to address those supply issues because they are and can impact when the next 9/11 occurs, not if.

We are currently at war. Although it seems to not be as much of a war as it used to be, we still are at war. I have over 70,000 individuals deployed in support of Operation Enduring Freedom that I support. I provide blood to over 19 facilities that have to have blood on their shelves, and we ship 400 units a week. That's a war.

So shouldn't we have an inventory management system and perhaps new products that provide a constant, safe, and adequate inventory?

Some of the things we should look at and are looking at, I know, are inactivation, rapid testing. DOD has a frozen platelet license submitted to FDA. On a note to that, the Netherlands, using the same procedure, has platelets in Bosnia and Kosovo where I can't put platelets and is transfusing them.

Should we have a hemoglobin-based oxygen carrier or some sort of oxygen-carrying resuscitative fluid or just a resuscitative fluid, and, ideally, for the Holy Grail, a lyophilized oxygen carrier plasma or platelet? But as we go through the longer shelf life, you're going to run into the same problem we're running into with frozen blood. Is it current in testing and is it current in screening? Is it still a licensed product? Those are issues that are going to have to be dealt with as we use longer shelf lives of products.

Do we need a nationally funded research effort? Well, I don't know, to be honest, but I think we have problems in that there is a limited commercial interest in these products. They're not seen as large profit makers. And I'm not a big enough user to make it a profit maker. It's a niche product. So how do we go about from a national perspective supporting the research, development, and licensure of these products? I think that needs to be grappled with.

In summary, we have a worldwide distribution system that is successful and has supported numerous conflicts. The frozen blood program was created in 1984 to bridge the gap where inventories of blood products were not available. It's not practical, it's not highly effective for mass casualties, but it's the only thing I have available at this point in time. An immediately available, rapidly transportable reserve would help my situation for the Department of Defense and for homeland defense I think has some practical aspects also.

If we had all these products available both at home and abroad, I think we would be able to impact and save lives.

Now, the only reason I bring this in is not for melodramatic purposes but to tell you that this war is different from other wars, and the key here are the time elements. In Operation Anaconda, the first casualties occurred at 3:00 a.m. The helicopters went down. The patients could not be evacuated. Contrary to Department of Defense doctrine, I have medics in Afghanistan taking blood in coolers with them when they go on a mission because they know they may not be able to be evacuated in a short time, such as we've done in the past.

A PJ is a parajumper, a para-rescue medic. So he carried two units of blood on this mission with him. The pilot of the helicopter was one of the casualties. He gave him the blood. But at 8:15 p.m., 17 hours later, the pilot died. Okay? That's a long time. So I need something to give to these people, and in that period of time, I think e could make a difference.

So just as a reminder, we are at war. We're doing the best we can to support everyone that is deployed in war. We have a frozen reserve that we have used in support of this war and that has been valuable. But it has problems, as I showed you. A liquid reserve on a national basis that could be managed and maintained I think would be advantageous to all of us.

Thanks.

DR. BRECHER: Okay. We have time for some questions or comments. Karen?

MS. LIPTON: And, I'm sorry, I missed the first part, but I did know--I had spoken to Colonel Fitzpatrick about this. One of the things we talked about before in one of the recommendations that we were going to have funding to take a look at this issue, the value of frozen reserves and liquid reserves, and I would just like to suggest that I think it is important that at least we put together some kind of funding and some kind of mechanisms that allows us to look at this and find out what it would take, not, you know, decide right away it's not a good thing but what it would take to have some system like this and then make a decision as to whether it's a good system or not.

DR. BRECHER: Mike, how big a reserve are you talking about?

COLONEL FITZPATRICK: That's a hard question to answer because we don't have a good estimate. My gut instinct and based on the planning factors that we used to develop the frozen blood reserve would be that about 10,000 units is a minimal number at four, five, or six sites throughout the country. But that's just--you know, people need--we need to look at that and look at those numbers and see how we would develop an idea of what a good number is.

DR. BRECHER: And would you position these reserves right next to the runway?

COLONEL FITZPATRICK: To be rapidly responsive, it has to be very near some site that it could be mobilized from. So, you know, that's either a large international airport or a large military air base so that you are able to do that.

DR. LOPES: If you have 10,000 units at four or five sites, that would be about 2,000 at each site?

COLONEL FITZPATRICK: Yes.

DR. LOPES: How feasible would it be to use the blood that's coming in for normal purposes within a region, say within a hundred miles, 200 miles of one of your air bases as a reserve that is not held until it's discarded but perhaps held four or five days on a rotating basis, then shipped out, and you would avoid then the need to have 10,000 extra units?

COLONEL FITZPATRICK: No, to be practical and efficient, that's why I said increase the days of supply at strategic locations, because then you could merely--you increase the shelf inventory so there's a constant level over and above what the old minimum level was, and that's rotated and used on a regular basis. But instead of a two-and-a-half-day supply, now maybe you have a 10-day supply. So if you take 2,000 units away, you're not making things even worse than they were before at that site.

DR. KLEIN: Mike, you may have said this, but are you thinking of Os, or are you thinking of different blood groups?

COLONEL FITZPATRICK: I'm thinking of mixed, but there would have to be a higher percentage of Os available, depending on the situation, because some situations you would have to respond to with only Os, initially.

DR. BRECHER: Mike, you said platelets are not rapidly available in DOD operations. Would lengthening the shelf life significantly--sy two days--make a difference?

COLONEL FITZPATRICK: It takes us 48 hours to ship it overseas, so that would mean constantly rotating a supply of platelets.

Now, in some sites, like--you know, we have two, quote, hospitals in Operation Enduring Freedom that would make regular use of platelets. Would it be practical to send a shipment every three days? It might. We'd have to look at the cost and practicality of that.

DR. BRECHER: Celso?

DR. BIANCO: Mike, maybe I can interpret what you just said in a slightly different way. One is obviously the purpose of the national liquid reserve. But if all of us were able to raise our inventories by a couple of days, you would have that national reserve.

COLONEL FITZPATRICK: It's true. The key is to be able to tap that reserve.

DR. BIANCO: But our doors are open. I think the issue that led to your concern and our concern is that we have not been able in recent times to retain an inventory that would be sufficient for these emergencies.

COLONEL FITZPATRICK: Yes. There are two points, Celso. One is the inventory. If everybody were at the seven- to ten-day inventory level, then the blood would be available. The next is a structure to get the blood. The Interorganizational Task Force is certainly the beginning of that structure, but you have to look at the strategic implications of where that blood is spread out. And so if you have to go to 20 sites to get it, bring it together, and ship it, you're going to delay the shipment to the place it has to get to. So we have to look at the transportation piece and what is the maximum number of places we would have to go to to get it out immediately. And one of the keys is that we retype those units before they go overseas. Okay?

Normally here a unit is retyped when it reaches the transfusion service to make sure the label and the bag contents are in agreement. When it's going to an emergency site, that's probably not going to happen. And I feel from a safety perspective it needs to have at least been typed again prior to being shipped out.

Now, it can be done far in advance to where it's not a problem, or it can be done at the site where it's shipped from. There's lots of different ways to do that. But I think that's another key element that needs to be processed in there.

DR. BRECHER: Okay. Thank you, Mike. We're going to need to move on.

We're now going to address how much is enough and hear representatives from multiple blood centers and transfusion services. So the first speaker is Richard Counts from Puget Sound Blood Center.

MR. COUNTS: Thank you. I'm Rich Counts from the Puget Sound Blood Center. I know this committee has a major interest in thinking nationally. I want to talk a little bit about some local things and use our program as one example, because the experience that we've had in our region has convinced us that there is a lot of--that there's primarily local solutions. There's a certain amount presumably could be done nationally in the way of policy, informing the public of the need and that sort of thing, but primarily there are major organizational and management strategies that each blood center needs to attend to.

Just briefly, the Puget Sound Blood Center is a regional community blood center. It serves most of--hospitals in most counties in western Washington, primarily, with the exclusion of the Tacoma area in Pierce County, which is served by an independent community blood center also.

This slide is just a very brief illustration of sort of the essence of the problem of maintaining a steady, adequate blood supply. I just plotted the use of red cells and also the blood drawn. The top curve is the number of red cells issued by day just for August of this year, and you see there is a strong periodicity. It's not exact but roughly weekly variations from day to day, different days of the week.

But the other thing to note is the variance daily from the mean is pretty large. We issue between 400 and 900 units a day, depending on the day of the week, and then in different weeks that can vary a little bit. And that's a pretty large variation.

In fact, this pattern of the large variance persists if you plot weekly use, and certainly even to a lesser extent monthly use.

The problem there is that if blood centers recruit donors on the basis of mean need, they're predictably going to have times when they're short, and they also would predictably have times when they outdate too many units. So we concluded quite some time ago that you got to have not only a way of estimating your mean use, but you got to have a rapid way of adjusting from day to day and week to week for variations in use.

Blood centers usually tend to think about externally directed strategies, donor recruitment, when they talk about strategies for a blood supply. And these are sort of the standard ones that we hear about all the time, and our center did that for years, and for many years since it was started in 1994, probably for its first 45 or 50 years, had severe, recurring, pretty regular and predictable blood shortages, crises, media appeals, and we have been trying to do something about that, and I'll tell you a little bit about our experience.

In the last four or five years, we have not had those kinds of severe shortages, and this is just a little bit about the experience of some things that we think were helpful.

We turned our attention to internally directed strategies, treating this as a management problem, an organizational strategy problem, as you would any other challenge. One has to develop the goals that you want, know what those goals ought to be. Then there's a significant organizational problem within a blood center because collecting and providing an adequate blood supply is a multi-step process that involves people in different departments. And they have to all know what the goal ought to be, what it really is, and be going in the same direction. And that has turned out to be a lot easier said than done. Once you know where you need to go, then you need to work on the resources and organizational leadership.

This is what I mean when we talk about the blood supply as a work flow. It can be modeled basically--if you're looking at the blood inventory, it's a fairly straightforward model as a reservoir with multiple inflows and outflows. And the properties of this system, this kind of system, we found was for the most part not intuitively obvious or even apparent to our staff, the recruitment, collecting, and laboratory staff, and they consistently were mystified at the shortages that would occur and at the fact that we could have a shortage one day, have a very large blood collection the next day, and still have a shortage.

So we needed to have a way of getting the staff organized and also educating them as to what the nature of the dynamics of the inflow and outflow of blood was to help them get realistic goals for recruitment.

The fact that there are many departments and many different individuals involved, as in any kind of organization, any other company, means that there are a number of sources of conflict, and to concentrate only on the medical or the scientific or even the statistical problems doesn't really adequately deal with these organizational problems. Obviously different departments will have different departmental goals. Individuals will have their own goals.

Many of these groups have very different styles of learning and communication. For example, the donor recruiters who are people people out generating enthusiasm have a very different approach to things than some of the laboratory people who are very precise, procedure-oriented, and focus on the technical problems.

That made in our center, at least, great communication problems between those groups. They don't have a common background. They didn't even in a sense speak the same language. Of course, good people tend to be competitive, and they have their own approach.

Now, I would like to talk just a little bit about modeling. One needs data, and that's where we start to begin to get an idea of how many units we need. So we started with historical data, and we keep redoing this for various periods as the use changes. This is just an example. We have nine donor centers in our region; 13 bloodmobiles collect about half of the blood on mobiles, and half at centers. And these are some mean data a year or so old of how we go about it.

From our centers, we try to establish sort of a baseline, a steady amount that we can schedule well in advance and know from the mobiles the same sort of thing. However, once you get working with mobile campaigns, it's not as easy to raise and then lower the numbers from day to day. So the calling to the centers is the main day-to-day adjustment as the needs change.

So we call about 12,000 a week. About 10 percent of those we get the right person that we wanted to talk to, a little under 300 appointments. Almost 80 percent--these are definite appointments that are made, and so the show-up rate is quite high compared to what it used to be when we just said could you come in some time in the next week. A certain number of walk-in donors.

With the mobile campaigns, we aim in a similar fashion, and altogether we end up with a little under 700--at least at that year; it's a little higher this year--per day that come in.

So then the system starts, and the other important data, as Ron Gilcher was pointing out earlier, is where the losses are. There are a lot of leaks in this kind of multi-step system, and there are losses at every step. In the first place, we have about 14 percent deferred. We noticed a little bit of increase with the CJD deferrals. It's about 1.6 percent of the people who register in our area, and I am aware that in certain areas of the country that is a much higher number.

So of the other ones that are not deferred, we attempt collections. A certain number of those aren't satisfactory for one reason or another, don't really make it back to the processing lab. So we have another loss there.

At our center in processing and testing, a certain number will be positive; others will be lost for one reason or another, technical reasons, and another couple percent are discarded. The others then are available and labeled and go into the inventory.

Now, the inventory has that inflow of that. A certain number are issued, and these are simply means here. I haven't put the standard deviations. But when you come to make our dynamic model, you'll see that we use the standard deviations, too.

Then in 35 to 42 days over at the right--you can't see it, but those are either transfused or expire.

We are in a position to export a few units, not an awful lot. That is mainly used in our system to balance the needs so as to decrease the expiration rate, so as to keep the outdates low. And we outdate--actually it's around 2 percent. It's kind of off the bottom there. And then, of course, there is kind of a recycling system. Some of the units are transfused, and after a certain period of time, some of them are returned that are issued to the inventory.

Now, we've used--in building our model as to try to anticipate what we need for the use, we've actually looked at the units issued per day because that's what the blood center actually has to supply each day. If one determines how many donors you have to recruit on the basis of the units actually transfused, one will tend to underestimate what you need because, from the blood center's point of view, you've got to be ready to meet the needs as they're ordered, not necessarily as they're ultimately transfused.

About two-thirds of our blood goes directly to patients in hospitals in the Seattle metropolitan area where we're the transfusion service. About a third goes to hospital blood transfusion services in other counties around.

And now we've been to those numbers, those kinds of numbers and did some practical things.

First, we made a model. Let me just take a second here, and I'll see if I can show you how that model works. I have an example. We used some software that's a model-building program in which I have described the flow again here: donors, collections, processing the inventory and the sorts of things I illustrated.

This is a program which allows you to put numbers to this to describe this process, and we used, we treated the important inflows and outflows, such as the number of donors arriving each day, and the number of units issued each day as a random variable, not just using the means, but plugging in the mean and the standard deviation so that the program each time there is a simulation will generate a different random variable to start with in each of those times.

This sets up then a series of difference equations which the program will recalculate as many times as you want. And as an example here, I've set it up so that it will run over a period of 60 days, and we can start with certain assumptions, and I've put in some numbers that we would then try and see if, over a period of time, this would be expected to give us, to maintain an adequate inventory.

The graph will show the levels in the inventory reservoir there, and in addition, as you'll see when it runs, there's some graphics that kind of give you an idea of how those vary also in addition to the graph.

So we run these simulations ordinarily several times because, again, being a stochastic process with certain randomness in a variable, you won't get the same outcome each time. And so in order to try to help our staff get a feel for the process when use happens to be up or donors happen to be down, we'll run it several times before we will decide that we're about right. The line there in the middle shows an inventory of 2,500 units which would be a little smaller than we would want.

However, as you can see, from the substantial variability in the day-to-day numbers, if you do different simulations, you'll get different answers, and of course that's the experience of blood centers, also, and it just points to the fact that we're dealing with a large variance. So, even if one calculates means and the statistics very carefully, you're still going to have to have a way of making some fairly rapid adjustments.

And then just to finish up, the other part of this becomes, again, as I said, not so much a medical problem, but a fairly straightforward management problem; in other words, how to get all of the people in those different departments, the donor recruiters, the blood collection, the laboratory people, going in the same direction.

So we set up this group using the model, and then of course they had to have adequate information. One of the first things we found out was that everybody was using different numbers. They happened, just I guess coincidentally, to be using numbers that were most convenient for their own department's function, but they weren't necessarily the right numbers, and it took the group quite a while to get to where they could agree on the numbers they needed, agree on the losses at each step and work backwards to agree on the number of donors that needed to be recruited.

The way we did it, and I think the way itbasically has to be done, is to have not representatives who are just people coming representing their departments who are going to take notes about what somebody else says, but people who are really responsible.

We basically had to get the department directors working together, and it wasn't necessarily a natural process because many of them were a bit reluctant. They didn't want other people involved in what their department was doing. They had to understand kind of the dynamics of the problem and what they were doing, and surprisingly enough, they had to work with each other enough that they could really begin to understand each department's role, that is to say, what the challenges facing each department was, otherwise they tended to be pretty unsympathetic, and it was easier to blame failures on another department rather than to realize they all had to succeed or fail together.

Once they got a common purpose, then they could be in a position of developing their plans, and then it became a matter, and it's still a matter of celebrating success and encouraging that kind of success.

So this is just my last slide, again, to emphasize this is a problem that can't be solved by one or two individual departments. For example, the donor recruiters alone can't solve the problem in any blood center or nationally. It needs to be a team, and at least in blood centers with a lot of technically competent people, forming a team isn't the easiest thing to do.

If you've got a particularly decisive leader who tells everybody what to do, that makes it very hard for the team to take any responsibility. In fact, they have no incentive whatever. It's even the easiest way because then if the team fails, it's the leader's failure.

Technical experts by themselves have a hard time collaborating. Again, they can't be representative, it takes time, and it's a long-term process. It took us at least five years, five/six years to make this change. We're still working on it, and I think it would take other blood centers. So that this is kind of a basic problem that I thought I might emphasize, recognizing that in different parts of the country in different communities, there are other sorts of external challenges and problems which I imagine you'll hear more about, but those are overlaid over these kind of internal problems too.

Thank you.

DR. BRECHER: Thank you. There may be time for one question or comment.

[No response.]

DR. BRECHER: If not, let's move on to the next speaker.

Jerry Sandler from Georgetown Medical Center?

DR. SANDLER: Thank you, Mr. Chairman. My name is Jerry Sandler. I direct a hospital transfusion service, and I understand that my topic is to be to address the factors that determine a hospital's blood component inventory requirement.

On the first slide I have the obvious, but I'll just review it for the sake of completeness. The factors that determine our inventory levels are, of course, the number of beds in the hospital, the case mix and how far we are located from the blood center.

In my hospital, our plasma is driven by a liver transplant program, platelets by our cardiovascular surgery program, and our plasma derivatives by a hemophilia center. We have the Lombardi Cancer Center that drives our red cells and platelets as well.

Another obvious point I think to this group is that having an adequate supply from the blood center doesn't mean that patients are going to get the optimal transfusion therapy, that the inventory should be driven by a proper blood utilization program, and that is organized by an appropriate medical oversight.

In our hospital, the medical oversight is driven by intensive educational programs. We have educational programs for the surgeons and for the other physicians who are ordering blood to make sure they understand the latest in terms of triggers and proper utilization.

Every day we have a blood utilization review. Each transfusion that was given during the previous 24 hours is reviewed retrospectively by a physician, and if there are questions, the physicians are seen face-to-face so that they know that their decisions are being monitored.

Prospectively, we have a computerized blood order entry so that when physicians order blood, it comes up on the screen of the computer with a list of the proper utilization--I'm sorry--the proper indication for what they've ordered. They order red cells and up come a few indications does your patient have this, this or this indication.

So, prospectively, they know what the indications are approved for the hospital for what they've ordered, and they have to pick among them, and that requires, in my opinion, a full-time medical director.

This is my last slide, and this is where I want to spend my time.

First, what we did is collect the data in the hospital for the last eight weeks. So this is real-time data, and we can state that we had no delays due to shortages. In fact, we haven't canceled surgery in the hospital in the last probably 10 years. Our community blood center has been very adequate in the supply, and we've had a good supply during that period of time.

I want to go over outdating of components because I think that's where the information is. First of all, with regard to red blood cells, we've outdated 0.4 percent, and I think that that's not unusual. It's a very low number, and I think that hospitals in the United States, with a 42-day shelf life of that product, are capable of managing in that range. I think that's rather typical.

I want to discuss the fact that we outdated 56 percent of the autologous red blood cells, and I think there are two factors for that.

Factor one, we have an informed patient population. They are aware that there is a very, very small chance, but there is a chance, that they will acquire HIV, hepatitis B, and particularly hepatitis C, and that the only thing that they can do to reduce the risks of the complications as far as they're concerned, is to give their own blood. We don't go out and actively pursue that, but I do have the attitude that it's like life insurance, the best thing to happen is at the end of the year to pay for your insurance and not to use it, and that explains how we got up to giving 111 units.

Now how about the 56 percent that weren't transfused? That reflects the education of our surgeons that they must not, even though they're under pressure by the patient to transfuse the blood because it will be reimbursed, if they transfuse two units of red cells that were given autologously, the surgeon knows it will save the patient $600. It will be reimbursed.

They don't transfuse it, and that statistic shows it, because of the risk of bacterial contamination and the risk of wrong blood to the wrong patient, which certainly holds in these special circumstances.

So the 56 percent, in my mind, reflects our unwillingness to transfuse blood to save people money and our willingness to stick to very tight triggers. We use very few directed donors. We wasted two.

Here is what I would like this committee to focus on, the number one point. Between the few days before the 4th of July weekend, and in preparation for the Labor Day weekend, Georgetown University Hospital wasted by outdating 11 percent of the 357 pheresis platelets that we had in our inventory.

We did that because during the past year the average shelf life that we have to deal with is two to three days. There's five days of shelf life, as you know. It takes two to three days for the regional blood center to get through testing it with 11 infectious tests and everything else that you know about. So platelets come to Georgetown University Hospital with two and a half to three days of shelf life.

If you're going to deal with a three-day weekend, and you've got a trauma center, you've got everything that I've listed, you are going to have to outdate. It's something that everyone knows in a blood center that there are two factors that come into this.

One is tremendous variation. I don't know where all of the patients went. Our surgeons seem to have gone on a holiday. The patients seem to have gone on a holiday. Utilization was way down during that period. That's one very important factor. And we must be prepared for a liver transplant or a cardiovascular patient.

I think if I gave this figure back to my blood center, and I were running the blood center, if I were running the blood center and I saw something like this, and the hospital started to order just what they needed, I'm back at the blood center, and they're just ordering platelets one-by- one and one-by-one, I would go to my donors and say we're going to cut back, and I would have less inventory in my blood center.

So we haven't pushed back on our blood center because we don't want them to do that and run out of platelets. We are right at that interface where we must have it. Someone in the system has to swallow the wastage that's required to be prepared, and where we're situated in the chain, we have to swallow it because the alternative is our blood center will cut back--at least I would think so. That's what I'd do--and they won't have it, and we'll have some shortages.

Lastly, I want to point out that we wasted 2 percent of all of the fresh frozen plasma that we have. We have a liver transplant service, a very active, and as you know, these patients are the sickest with liver disease that could possibly have a chance for a successful liver transplant, so we use about 1,300 units during this period of time to keep them tuned up in case a liver comes available for them.

Two percent of the bags, when we take them out of inventory, put them into a water bath, have already been broken by a crack because when the plastic is frozen, and it's transported hither and yon, and comes in, even though it's bubble wrapped and handle with care, we waste 2 percent, and that's a lot to be wasted in a way that I think could be prevented.

As a parenthetical note, I would say that when I was directing the National Rare Donor Registry for the American Red Cross, hard to believe it, but 10 percent of rare red blood cells had cracked bags after being transshipped. It's an extraordinary number and something that I think industry could work on.

The Rare Donor Registry, of course, is if you have a unit of O-negative blood, and it's TJA-negative blood, you ship it frozen, dry ice or whatever, to someplace and say, "Don't open it up and thaw it unless you really need it," and they kind of hold onto it, and they don't need it, so they ship it to the next place, and by the time it gets used, it's probably been in one or two places, and that accounts for that breakage.

But just to summarize, then, I think the supply in this area is adequate, and it can be managed adequately without much outdating. I think that there will be a lot of outdating of autologous red blood cells in certain places, but I would like to attribute that to things other than inventory management. I think there are many factors that determine that, which I mentioned.

I think that the issue on the floor is really how can we prevent the waste that's required when you have a two- to three-day shelf life of a very important product that you can't run out of, and it's a crying shame that blood gets broken because plastic breaks, and I think that industry is capable of solving this problem.

Thank you for your time.

DR. BRECHER: Thank you, Jerry.

Is there a comment or question?

[No response.]

DR. BRECHER: If not, I think we'd like to keep moving and try and stay on time.

The next speaker is Robert Jones from the New York Blood Center.

DR. JONES: While we're getting set up, I distributed to--first of all, I want to thank the committee for the opportunity to come and share with you our experiences over the last several months. My statement will probably sound to some of you like another TSEAC statement because that's one of the things we live day-to-day, and I wanted to share with you our experience, especially in light of our 9/11 experience.

I've shared with you all a written statement which you can read along with as I read it to you.

One year ago our lives changed forever as we experienced an historic attack on our country and way of life. In our world of blood collections and transfusion medicine, the world changed dramatically as well. Prior to September 11th, as I'm sure you all remember, our world was intensively involved in a debate over blood donor deferrals for VCJD.

The impact of FDA guidance was predicted to be substantial, and preparations were already underway to deal with the loss of blood donors, as well as our imported supply of Euro blood for New York. As the disaster of September 11th unfolded, an unprecedented surge of blood donations brought a new set of problems of oversupply that none of us would have predicted. Our immediate reaction was to assume, and at least hope and pray, that the problems of lagging blood donations and short supply, with which we have struggled for years, would no longer be with us.

In the months post-9/11, we began dealing with the unfortunate circumstance of outdating thousands of red blood cell units for which there were no transfusion recipients. This began precisely 42 days after the disaster and continued for months afterwards, as donations continued to be strong through December and January.

Now we believe that this phenomena would not be sustained, so we continued our preparations for the implementation of VCJD donor deferrals, the first phase of which was scheduled for May 31st. We prepared with major investments in new-donor recruitment and collections capacity, as well as with new agreements for sharing of surplus supply from other U.S. blood collection agencies such as ABC centers, BCA, and American Red Cross, and I'd like to add that we really appreciated, and we were working very collaboratively with those agencies.

Our instincts about the donations trend were correct, as we saw that the surge of September and October returned to our baseline in November and descend into a trough that continued until May of this year.

I will just point out that on this slide, this trend line here is really just fit to this data. It doesn't really necessarily match our expected line, which I'll refer to later. Given the gains from the surge, and the losses from the trough, and the losses due to units discarded due to outdates or processing problems, we now calculate the net loss to our available supply of over 21,000 units or about 5 percent of our annual whole blood collection. So this event, which we all initially were hoping would be a positive event in terms of available blood, turned out to be a net loss of 5 percent for us.

Since June 1, when the first phase of VCJD deferral was implemented, we have experienced a surprising and catastrophic loss of donations of some 20 to 25 percent below expected levels. So we were just creeping up, back up toward the baseline, which our expected line is up in here somewhere. As you can see, after here in January, we were starting to creep back up, and then in June, July and August, we've had dramatic falloff in donations.

Now, last summer, when estimating the impact on our donor base, we surveyed current donors and found that the percentage of our donors that fit the VCJD's criteria proposed would be approximately 7 to 8 percent, which translates into a loss of about 10 percent of our donations in the New York Metropolitan Area.

This current picture is compounded by self-deferrals of those who perceive that they fit the criteria, plus are very difficult to quantitate, but I think almost universally understood across the world and the U.S. at this point, donor apathy.

As we interview donors and donor group leaders, we believe that the apathy is due to anger with blood collections over discarding units, the poor understanding of blood's perishability, and more importantly in our area, severe economic impact of the disaster, which has left many of our corporate blood collection partners with downsizing and low employee morale. We're, at this point, desperately now trying new donor recruitment strategies, trying to find new donor groups to make up for the shortfall in donations.

Although we remain optimistic, if these donation rates do not improve, our supply assumptions that rely on other U.S. supply may not be sufficient or prove adequate supply of RBCs for our service area.

Equally painfully for us, it will raise some difficult financial issues of whether we can sustain the capacity which we have built to collect these levels up in here, and we deliberately built up these resources over the last two years.

Now, as previously mentioned, our RBC supply status since 9/11, was remarkably high through the first few months after the disaster.

Now go to Figure 2, hopefully. This is really a plot of our total RBC inventory as we've had a month-to-month. Now the falloff in donations that started occurring in December and showed up in the first part of the calendar year was compensated by the new supply that was coming in from U.S. suppliers that I mentioned as we started to arrange and our European supply which continued to come in. So we have a biphasic curve here.

This was the 9/11 inventory surge. It started dropping off, and then during the first few months of this year, we had another rise in inventory building for the summer, which we knew would be a problem because of the CJD criteria, and now you see that we've been in a slide since May.

Now the overall curve does not show the type-specific problem experienced by all blood collects as had been mentioned earlier. Because Rh-negative blood has a higher demand than availability, we've had to reduce our shipments to our hospitals O-negative and A-negative units for almost the entire summer. Therefore, we've been in short supply of these units, in spite of having the overall RBC supply that appears to be adequate.

Given the surprising donation deficits we now encounter, the efforts we made to build a cushion up for supply for the loss of Euro blood, which we thought was maybe 30 percent higher than we needed, may now prove to be inadequate.

Given the problems with donations experienced by ourselves and most other blood ollection agencies that we know, it appears that the impact of VCJD guidance is greater than anticipated and threatens to severely weaken our national abilcity to provide for patients who need transfusion.

Although our supply issues have been limited to Rh-negative RBCs thus far, my understanding is that there are other parts of the country that have supply issues for the entire summer. It appears that the convergence of the post-9/11 apathy, the reaction to publicity about blood outdating and the VCJD deferrals, along with economic impact, have produced a danger to patient care that rivals historic blood shortages of similar severity.

The historic and current difficulties with the blood supply are driving transfusion practices that potentially endanger patients. We saw some of those listed earlier this morning. The best example that I know of is the practice of administering Rh-positive-type red blood cells to Rh-negative transfusion recipients. This practice carries measurable risk for patients, but has become more common due to chronic shortages of Rh-negative RBCs.

Other practices driven by shortages include delay of surgical procedures, loss of organs for transplantation due to low blood availability and diversion from emergency rooms with inadequate blood supplies. These practices are difficult to document, and as Jim MacPherson pointed out, not often reported by hospitals, but informally they are increasingly reported by transfusion specialists as blood availability shrinks relative to demand.

As we survey this medical landscape, the question should arise as to whether we are introducing greater risk to patients by restricting the donor base than we are protecting against by reacting to theoretical or remote risk of transmission of infectious disease.

The problem is that risk assessment is done only in the isolation of the specific issue and not examined against the background of supply losses all along the supply chain. That's been brought up by other speakers as well.

All subtractions from the supply from donor deferrals, testing, processing, distribution, inventory management and so forth are cumulative and take away from the total available units for transfusion.

Now, in fairness to the regulators who make the difficult decisions to protect the safety of blood, the public, perceptual and political logic behind these policies is somewhat understandable. They view these decisions as public health policy, and the blood supply is an elastic resource that can expand to meet public need.

What we've learned in the past few years, and certainly in the last few months, is that the supply is not as elastic as necessary to adopt to policies of this impact and the patient care has been jeopardized. In our estimation, as a medical care provider, this is where medical logic of these policies falls very short. All of the medical transfusion specialists with whom I've spoken also agree with this.

We urge, again, immediate examination of the VCJD deferral policy against the realities of total risk to transfusion patients. We feel that the current and the future blood supply horizon and the practices to adapt present a greater danger to the population of patients in need of transfusion than the possible transmission of VCJD via transfusion and probably other agents as well.

We also urge FDA to regularly examine its blood safety policies--historic, current and future--against the risk of short supply and to work with the medical community to do this examination.

Finally, the events of 9/11 bring new meaning to emergency preparedness, of which blood supply is an important element, and this has also been brought out earlier. We were fortunate that we had adequate blood on the shelf for the events of 9/11. However, blood donor restrictions that continue to erode the nation's blood donor base do not prepare us for the next terrorist attack that could require a blood supply that is not on our shelves. This is another grim example of how medical logic must be incorporated into decisions that impact on blood safety and supply.

I'd just like to add a couple of things from comments I heard this morning. It seems like we talk enough about regional, and even seasonal, shortages to understand them as sort of being a fact of life and even acceptable. But I remind you that regional shortages tend to take place where most of the people are, and we seem to look at this map of the United States as though, well, there's not a shortage over here in Nebraska, so we should be able to move the blood over from Nebraska over to New York.

Unfortunately, there are not nearly as many people, and donors, and blood supply in Nebraska to meet the New York need. So that is something I think, as we try to look globally, we should try to keep in mind.

Now we've also heard probably five ways of monitoring the blood supply this morning, and it reminds of a bunch of doctors standing around a patient's bed who's dwindling away and trying to measure all sorts of things while the patient dwindles away. I think we really need to start taking some action.

I'd really pick up on Mike's comment. Intervention is what we need. I would suggest that as we design intervention, we not only think about increasing the donor base, but we're thinking about a more rational way of measuring the risks that are out there and include the risks that there are currently, and growing, for transfusion patients.

Thank you.

DR. BRECHER: We have time for one comment?

DR. EPSTEIN: Yes, Bob, I'd like to address one question to you in clarification.

First of all, I agree with your larger point about looking at supply issues in the larger context of risks and benefits of policy as we've been trying to do, and I don't dispute what you've had to say about the situation in New York and the New York Blood Center.

However, I want to address the impression that a chronic shortage, as a consequence of the VCJD deferrals, is significant at the national level because what I think we've heard from American Red Cross and from America's Blood Centers is that collections now are as good as they were with historic norms before 9/11, and that's despite the fact that most of the deferrals have already been implemented in both components of that system, representing 90 percent of all collections.

So I would like a clarification whether the larger national picture is or is not in concert with what you've presented, which is a 5-percent-below- expectation collection rate, and maybe that's really a question for folks like Peter Page or Celso Bianco, but I think it's important to distinguish the impression of what's happening in New York now from whether that's the national picture.

DR. JONES: Well, our actual picture, I think you said 5 percent, it's actually 20 to 25 percent below our expected donations. We built capacity to collect 20 to 25 percent more in our plan. If you look at our curve, we were ramping up at a rate where we would have been at 25 percent higher than we are now, so that's a big drop-off, and we had predicted 10-percent loss, and now we're looking at 25-percent loss.

We do know that there are lots of perceptual deferrals, self-deferrals. It's hard to get those people back. I don't know everybody else's data, but what I hear anecdotally from other ABC centers, not all of them, is that they've never seen a worse summer in the history of the people that have been in the business; that, on the background of what we hear reporting accurately, is an increasing demand for the product.

So it's a dynamic situation where you're not collecting as much, certainly not as much as you need; at the same time, you've got a higher demand.

I'm not going to try to pretend that all of what we see is due to VCJD. There are other things going on. We certainly saw this huge trough after the 9/11. We know that some of that continues to, that psychology continues to drift into the donor base. However, there's a very strong temporal relationship with the implementation of our VCJD criteria and the sharp drop-off in the summer.

We do hope that it starts coming back, but we think we're dealing with a much lower base of blood donors than we had before, and I think that's probably true for Red Cross, that despite the fact that they implemented back in October, they don't have the donor base reserve to make up for the shortages they would appear to have in the summertime. We know that they lost some 10 percent of their donor base. You predicted that.

So it's definitely a factor. I just think it would be wise for us, in a medical sense, to look at what we're trading off here.

DR. BRECHER: I think we have to move on. Perhaps the next couple speakers might comment on this particular question as to whether they have seen a drop-off in their donors since implementation of these new requirements.

Peter Page with American Red Cross?

DR. PAGE: First I'll just make a few comments on that. I did not bring data with me about our collections versus goal for the last six or seven months. I did show that year-to-date this fiscal year we are behind our collection goal, and we have been struggling. I also showed that our inventory today is barely two days' of inventory, which is at a critical level.

We did lose some donors when we implemented our VCJD deferrals in October, and then that culled and dropped down to less than a percent, but as many people pointed out, that doesn't count the people who don't even come to show up to get counted as being deferred, so we don't know how many we've lost.

We've had an ongoing struggle with the blood supply this year. It's not as easy to recruit and collect as it used to be, and we are not meeting our goals as well or consistently as we have.

I'll go on now in continuation of this morning's presentation talking about how much is enough or optimal red cell inventory. As I mentioned this morning, we must balance across the system, but also our total demand requirements. If we see that demand is increasing or that our collections need to increase, it takes us some lead time to increase.

It takes us three months once we decide. We have to decide how much and where. We then have to advertise to hire new people, we have to interview, evaluate, recruit, hire and then training for phlebotomy and medical history is eight weeks because of the complexity of the questions and the procedures and regulations they have to learn.

So there's at least a three-month delay before we can make a substantial increase in collections. That's on top of replacing turnover or staff that leave for other opportunities in the meantime.

I'm going to talk next about customer service levels, volatility of demand, outdates and focus on type mix--that's ABO mix--for a while.

Regarding customer service levels, Leo Demande [ph] did a study in March of this year comparing our average daily inventory level with our customer service level and expiring units, and I'll show you that data in the next two slides, which suggest a need to maintain seven days of supply or 175,000 units for us to meet our needs.

Now that is based upon a couple pieces of data. This is one. Each red diamond represents one month of data for the last 12 months. On the bottom axis is our average total inventory for the month. Averaging the inventory for each day in the month, 30 days or whatever, that's the average inventory for the month. You'll see three months off to the right, where we have between 200- and 300,000 units of inventory. Not surprisingly, that was September, October, November of last year. The inventory was as low as in the low 50s, but as you heard, on August 31st, it's even lower than that right now.

Now the Y axis is labeled Customer Service Level Percent. That is ordered versus shipped. If customer ordered 100 units, and we shipped 94, that's a 94-percent customer service level. We've had that system in place for more than a year in all of our regions. It is still not consistently applied in every region, and there's some other issues we need to work out, but this is data for the last 12 months.

It's interesting to me that when we have between 200- and 300,000 red cells, we only filled 97 percent of the orders. Now I've learned that a factor in that is, if you order on the 31st of the month to be delivered on the 1st, that order on the 31st is counted as not filled. So if there's 30 days in the month, that's 3 percent, and that may be part of it, but there's other fine-tuning we need to do on this.

So if you try to try a line on this curve, and you have a target of 175,000 units or a seven-day supply, that equates to a 96-percent fill rate which, apart from the end of last year, we did make on one month and came kind of close to several other months. So for purposes of our current thinking and projecting a target, it would be for us to have enough blood in our inventory to meet 96 percent of customer needs. That's our approach.

Volatility of distribution someone else mentioned earlier today. This is based upon daily net distributions for the four months of April through July of this year, weekdays only, divided by ABO type. It is the mean, plus or minus two standard deviations. So if we incurred both extremes of two standard deviations, there was a weekday when we only distributed 5,000 O-pos and another when we distributed almost 14,000 O-pos, and I can tell you that there is that variation.

Now this is volatility of distribution, not volatility of demand need or orders, which I don't have, but we're going to be looking for. I think you can see that the variation appears to be greater in O's than A's, and I was quite struck by this data when Leo showed it to me.

Now the type mix discrepancy. There is something that is called the AABB mix, which is that column of percents. When one orders 100 units of red cells to be shipped in an export or import contract, traditionally, that is what is sent among blood centers in the United States, rather than sending only O's, which would lead the A's to outdate in the exporting region.

So you can see those percents, which I'm told are ancient, have not changed, and I can't find the source for them. If you look at our last fiscal year net red cell distribution by ABO mix, we distributed 40 percent, which is 2 percent more than the AABB mix of O-pos, and AB-pos, for example, we only distributed 2 percent, as opposed to the 3-percent mix.

If you look at all of the units we outdate and take the percentage that outdate, while 40 percent of our distributions are O-pos, only 23 percent of our outdates are O-pos. Whereas, 2 percent of our distributions were AB-pos and 16 percent of our outdates are AB-pos.

The same is basically true amongst the Rh- negatives. There is much less relative outdating of O's, more of A's and AB's.

Now, if you look at the population, ABO RH frequency, and you look at it by ethnicity, and I'll compare it to the AABB mix again, the AABB mix is not too different from the white population. However, if you look at Hispanics, 51 percent of Hispanics are O-pos, 37 percent of whites, and the AABB mix is 38 percent.

So if Hispanics are likely to get transfused, as anybody else, historically we--we, anyhow--have not done as well in recruiting amongst Hispanics. We have made progress, particularly in some of our regions, but there are a number of challenges in doing that.

If you look at the last two lines, the Southern California population has a mix 43-percent O-pos, and the AABB mix of 38 percent that they would import is 14 percent less. So if Southern California relied upon blood from the rest of the country, they would be quite short of the proportion of O-pos's needed, which is a challenge for Southern California and some other parts of the country.

This is a population projection going out 40 years for Southern California, divided by ethnicity, and you can see that the Hispanics, which are a substantial proportion already, are growing already and are projected to grow even more, which will make the relative greater need for O's in transfusions greater in that rapidly growing large metropolitan area.

I'll skip this in the interest of time. It just shows that if you import that AABB mix, you get more A's than you need in the outdate, and you don't get enough O's.

In summary, maintaining a two- to three-day inventory of red cells is not sufficient to handle the normal usage and its variation in distribution and also be prepared for a catastrophic event. We need to have higher inventories in order to be prepared, and the cost of preparedness is an increased number of units that expire, particularly A's. If you collect enough the regular way to have enough O's, you're going to outdate a lot of A's routinely.

So blood collections must mirror blood usage by type. And as we look to increase blood collections, focusing on O's and also B's is something that should be considered, rather than spending lots of money to collect lots of A's, a proportion of which will end up not being used.

Thank you very much.

DR. BRECHER: Thank you. Peter, if two or three is not enough, pick a day. How much do we need?

DR. PAGE: Seven days if the ABO is by AABB mix. That's 175,000. I can't describe, in days, how many we need if they were proportionately greater O's. We can give that some thought, and we can come up with whether maybe 100,000 is okay if 75 percent of them are O's. I don't have a number, but I think this posed a framework for having some considerations, discussions, and models along those regards. I mean, we need more and more O's.

DR. BRECHER: It may be that the A's go to hemoglobin-based--

DR. PAGE: Let them be platelet pheresed, yes.

DR. BRECHER: Keith?

DR. HOOTS: I know we're not here to talk about recruitment very much, except as it applies, but targeted demographic recruitment, has anybody gotten very far in, say, California, Texas, places where Hispanic populations are a high percentage?

DR. PAGE: The Red Cross region based in Los Angeles, the Southern California region, which one of the Red studies made a particular effort in that regard and monitored their results, and I'm sorry I don't have them with me, but I believe that Hispanic participation increased by more than 40 percent in the year that they launched and initiated that effort, which is continuing to go on.

It requires contact by Hispanics with Hispanic leaders in the community. It makes a difference, and there's some cultural challenges that are different in each of the ethnicities that need to be overcome.

DR. LINDEN: Peter, your data on outdating were sort of surprisingly high for O-pos, and particularly O-negative. Can you comment on why that is, why it can't be addressed towards inventory rotation, and have some of your experts given thought to possible strategies to improve on that?

DR. PAGE: I can't flip back readily, but the percent outdating given for O's was of all of those that outdate, 23 percent is O's. It's not that 23 percent of O's outdate.

We supply a couple thousand hospitals, many of which are in rural, outlying areas, who like to have at least an O or two on hand just in case, and so there are some there that don't get used, and the cost of transporting them back and forth frequently is great.

Also, I would say that there has currently been a variation in local inventory management and credit for returns. We have a substantial number of O's that the hospitals return to us with less than 24 hours dating remaining. We work hard to use those, but I would say that that is probably almost all of the O's that end up outdating, and we're not currently in a position to rejuvenate them for some reasons which include regulatory and package insert constraints.

I was surprised at how big the number is, too, but I would say if your outdate is zero, you might have been short.

DR. BRECHER: Thank you.

We are now going to move on to Ron Gilcher in the Oklahoma Blood Center.

DR. GILCHER: Technology change takes time. I might start out with a couple of introductory remarks while we're getting my CD-ROM in place.

Initially, I was asked to give a talk that encompassed the whole title of this agenda, and I prepared that talk, and then discovered that the topic had been changed to how much blood is enough, and so I've prepared a talk on that. You all should have handouts. If you don't, beside my desk there are additional handouts that we can distribute.

So, while we're waiting for the CD-ROM, how much is enough? That question is ambiguous because blood serves two purposes, and we perhaps haven't talked about that enough today. The first purpose is availability. Even if never transfused, blood is an insurance policy that allows a medical or surgical procedure to occur. I think we sometimes forget that even if it never was transfused, it still serves a purpose, and obviously that which is transfused saves lives or improves the quality of life.

If we compare the year 2000 against the year 2002, how much is enough is quite different. And the difference, as far as we're concerned at the Blood Institute--and by the way, the comments which I'm making really reflect our particular actions regarding how much is enough--the difference is the concern over terrorism and bioterrorism, which has created, we believe, an additional need for more blood reserves, both liquid and frozen.

Let me make sure you all have handouts there.

The way we function enough means that all hospitals have all of the blood that they need for availability purposes and for transfusion purposes, whether that would be a normal or crisis as far as they're concerned.

Enough means that the reserves, liquid and frozen that we have in our system, must handle any major crisis.

Enough means that the blood does not have to be imported into our system, and we have not imported blood into our system for now over 21 years. Therefore, we always are in the position to be an exporting or resource-sharing center.

Enough also means that the outdating must be managed, as we just heard from Dr. Page.

I want to define crisis, and this is again on the handout, and hopefully the CD-ROM will be up in a minute. We really have three kinds of crises that we face. The first one is the sudden increased usage crisis--the Oklahoma City bombing, the Oklahoma City tornado. But the reality is that the amount of blood that's needed in those crises is really very small compared to what the donor turnout is, and of course that was seen with the World Trade Center.

The second kind of crisis, which we have not experienced, but which we're planning for with the increased reserves, both frozen and liquid, is a decreased donor availability; that is, exposure to an infectious agent that could, say, for some period of time, prevent us from drawing a large segment of our donor base.

And then the third is the loss of a blood center functional unit, and we had that happen a little over a year ago, where one of our blood centers was completely destroyed by a wind shear. But, in fact, because of the infrastructure we have in place with multiple blood centers, it was completely invisible to the hospitals that were served.

So those are the three kinds of crises with which we potentially have to deal. So enough as far as reserves go. As far as we're concerned at the Oklahoma Blood Institute, it's having liquid for immediate transfusions and then frozen reserves for us are to back up our liquid reserves, and you can follow the handout.

Now, interestingly, as we plan for the future, we're looking into the distant future as well, and enough to us means to move to an all Group O system. Now obviously that's not possible at present, but potentially in the future, it will, with enzymatic conversion of Group A, B and AB to O; that is, what's going to be called the ECO or the enzymatic converted O.

Just for your interest, we've actually converted two of our smaller hospitals in our system currently to all blood Group O because, from a safety standpoint, that is much better than for them, and from a logistical standpoint for us, it is better to have them just be Group O, just O-pos/O-neg, and they are way out on the fringes because we're dealing with a huge service area that's 300 miles across.

[Pause--computer failure.]

DR. GILCHER: I'm going to go on with the talk, and hopefully you've got the handout.

One of the things that we have done, and we've been developing this over the last three years, and if you look at your handout, the next slide on there says BUSS, which stands for Blood Utilization, initially, Blood Utilization Software System, and now is a Blood Utilization Support System. It's in the process of being validated in our system, and it fits extremely well into the Trans-Net concept which FDA is developing.

Essentially, what we have done is to develop a Windows-based, Internet-accessed, real-life, that is, inventory management system, whereby all of our hospitals will be, the big hospitals will be on-line all of the time through the Internet.

The small hospitals will do a call-up, and those hospitals will scan the blood unit identification number, the product code, the expiration date, and the blood type. Those are all scannable. They're eye readable and machine readable. And from that it will transmit back to us what they have in inventory. When they go to cross-match the unit, they'll scan it again. It's a very fast process. It'll tell us what they have on cross-match. When they transfuse it, again, it will scan it and bring it back to us so we'll know what they've transfused.

In addition, we've put in clinical flags, as we've called them, which tell us when there's an inappropriate order, and we've done that because ultimately we wanted to improve utilization, and I'll give you an example of a clinical flag.

If the first order was for a gamma irradiated red cell unit, but the next unit that they select for that patient, because this is now patient specific, is not a gamma irradiated unit, then it will flag in our system and one of our physicians will call and say either your first order or your second order is inappropriate. So that is this new Blood Utilization Software System.

The next one is a service map that I was going to show you to show you the extent of our system, which is extremely large. We have a main center, and you're going to have to visualize the State of Oklahoma with its panhandle sticking out there. In the center of the state is Oklahoma City, and approximately 100 miles away in all directions there are six what we call subcenters. So we have the main center and six subcenters that comprise our system, and we're serving now, and we've had 10 hospitals that were added just within the last month and a half. We now serve 89 hospitals.

The way that we store red cells in these hospitals is the plan is to always keep maximum inventory within the hospitals, and those inventories are set by both OBI and the hospitals. They would like more, we would like less, we come to a happy medium on what the amount of red cell storage will be.

Our subcenters, which number six, and each approximately 100 miles away, our plan is to keep them also fully stocked. And then our main center will support, in a sense, the Oklahoma City hospitals, plus the whole system, but that's where we will take the hit whenever there's not enough blood because that's an easier one for us to refill.

The next slide talks about the number of hospitals, 89, and the number of units that we transfuse. We now transfuse about 11,000 red cells per month. The largest hospital in our system transfuses 1,200 units, the smallest hospital five units per month.

Going to the next slide, those AB hospitals are currently storing about 4,000 units of red cells. Our subcenters store about 1,250 units of red cells, and our main center stores 1,200 red cells. So if you start adding that up and start dividing those numbers out by the 11,000 that are transfused, the total system currently is about 6,450 units, plus or minus, or about a 17-day supply for the whole system. That's one of the things that, to me, has been a problem with this meeting and others is how do we define what a day's supply is. We all need to standardize that definition, and I'm really giving our definitions here.

Our main center, and our six subcenters then, have about 2,450 units, which equates out over a 30-day period of time, that that's a seven-day supply, in addition to that which is in the hospitals. Theoretically, our hospitals have a 10-day supply that's independent of the center and the subcenters because that's how much blood we are keeping in their inventory.

So how much is enough? Our objective is to add a frozen reserve to the liquid reserve that I've just talked about. Our frozen reserve is going to be integrated into the liquid reserve so that our current plan is that of the 2,000 units that we want to put into the frozen reserve, all Group O, O-pos, O-neg, that they will be used at the rate of 500 to 700 units per year. There will be no additional charge to our hospitals. They will use the new hemonetic system that will be a 14-day liquid shelf life for those units.

So our proposal is to add 2,000 Group O's, and that will give us an additional five-and-a-half day reserve. So our total reserves will then be 4,450 red cells or about a twelve-and-a-half day supply that's independent of what the hospitals have.

I'm just about at the end of the talk. I'll just run these slides very fast here. These are the ones that I've talked about. The ambiguous question; enough in the year 2000, very different from the year 2002; what enough means to us, the four points, again, on your handout--and I'm sorry to go through these quickly, but I don't want to take any additional time--what a crisis means to us, the three, again, important points: sudden usage, loss of donor base, loss of a blood center functional unit.

Reserves, now we feel need to be both liquid and frozen; enough for the future, leading to an all Group O system, not possible yet, but in the long term, possible; the Blood Utilization Software or Support System that I told you about; our service area. Again, I think this is the one that I do want you to see. You can see the main center in the center of the State of Oklahoma, and then where the other subcenters are located, that decentralizes our blood supply so that we can call upon that, we can move it very quickly.

Again, the plan that I talked about with the hospitals and subcenters. We currently serve the 89 hospitals with 11,000 units; the 17-day supply currently for the whole system, which will go up to about a 23-day supply with that frozen red cell addition; and then the proposal for the frozen storage, which is the 2,000 units, by the way, to be located at two different subcenters, and that is to decentralize that large supply of blood so that if any kind of disaster hits, that we will have a decentralized or additional decentralized blood supply.

One last point before I address this slide, and that is that, with the addition of the frozen reserves, we can mobilize within two hours a thousand liquid units in our system that could help our system or virtually go anywhere. As I mentioned to Colonel Fitzpatrick, Tinker Air Force Base is 10 minutes away from our main center. We could literally move 1,000 units, all types, 500 O's, within less than two hours to Tinker, where it could be disbursed if there was a military kind of disaster, but that is the capability of our system.

The very last slide, and I'm glad that now I have the slide up on the board, was actually what I was going to talk about. What you see up here is not original to me. This is the summation of a conference that occurred at the NIH. It was an NHLBI conference, I believe, February 28th of 2000, and chaired by Barbara Alving, Dr. Barbara Alving, where 40 representatives of the American Red Cross and 40 representatives of the independent blood centers met to talk about blood availability in this country.

The conclusions of that meeting are really summarized on this slide, and I think they're worth restating and hearing, and we've heard it this morning already; that there needed to be adequate reimbursement to the hospitals, and that really is the government and the insurers; that there needed to be support from the top down, meaning that the government leaders and the industry leaders needed to really endorse the blood programs that we needed to get support for, donations at the corporate level while people are working on the job; and then the last point, which is I think absolutely critical, and I'm going to add my own personal viewpoint here, is education from the ground up; that is the importance of social and community responsibility.

I have highlighted what I think is something that we now have to say to the American public, that is, that they have an obligation to donate blood to support this country with the potential for terrorism that exists.

Thank you.

DR. BRECHER: Thank you, Ron.

In the interest of time, we're just going to move to the next speaker, Lou Katz from the Mississippi Valley Regional Blood Center.

DR. KATZ: This should be a little quicker than Ron's.

I'd like to thank Captain McMurtry and Dr. Brecher for the invitation. When I talked to Captain McMurtry, I said, "What the hell do you want me to talk to you about? I'm from a stinking little blood center out in the middle of nowhere." And somewhere or another he had heard that we always have blood, so I think that's probably why I'm here.

We are a stinking little blood center out in the middle of nowhere in Eastern Iowa on the Mississippi River. We serve 34 hospitals in 30 counties. I'll show you a map on one of my slides. We have 10 fixed-donor sites throughout our region, and our collections are evenly split between these fixed sites and mobile blood drives all over the area.

We are budgeted and will make our goal this year of 88,600 whole blood and apheresis collections in 2002. That's 14-percent up from last year, so up 14 percent in one year. I'll show you a picture of our region. It's not quite as spread out as Ron's.

You can see the Mississippi running through the middle of that red area, and our core area is very--our core counties are right here where Interstate 80 and 74 and 88 all come together, two counties--Scott County in Iowa, Rock Island County in Western Illinois. The population of the entire region is 960,000. Our two core counties, the aggregate population is 310,000.

In those two core counties, we draw 14 percent of the eligible donor base. Fourteen percent of the eligible donors are drawn each year in those two core counties, a little less than that in the others. They have less population, obviously.

National estimates are 5 percent of eligible donors donating on an annual basis. So some people say we overdraw, some people use what is perhaps a more pejorative term, exploit our donors. Our donors would disagree with those characterizations.

Well, how much is enough? I don't know. This balance should be, it seems to us in Eastern Iowa/Western Illinois, to be an easier balance to reach the more integrated the National Blood Collection and Distribution System becomes. That's the philosophical underpinning of my center's operational approach, and has been since it was founded 27 years ago by a guy some old people in this room will recognize, Dick Novota [ph]. If you don't have any gray hair, you won't know who Dick is.

But the integration I'm talking about doesn't imply corporate integration. It doesn't mean we all have to be the Red Cross or UBS, but it's a perhaps less-formal type of integration, referring to a network to maximize collections and then to get the blood where it's needed.

In our model, excess collections are used to buffer our system from day-to-day fluctuations, and you've heard about those quite graphically, and most particularly I think from people in the larger urban areas. These fluctuations lead to alternate shortages, and wastage and are kind of the pain in all of our butts, I guess.

So we endeavor to buffer our system with excess blood that then goes elsewhere to patients in need, and so the answer for us is there's never enough blood in the system, and I think that's why we do what we've done.

As a consequence of that type of operation, what we're interested in, so that we know how to plan and what to do next year, we're interested in long-term relations with importing areas so that we can build our program to be as reliable to them as we are to our own system, and I want to point out we have never had an emergency appeal in our system in 27 years. We have never gone to the media and said we're in trouble, not once. It probably would take an act of God because I know our CEO wouldn't allow it.

Well, so what are the factors in supply and demand? These are the simplistic ones. I think you've heard about most of them already. Donors recruited, donors referred, dah, dah, dah, and then the demand is on the other side. I would argue that donors deferred, lab and manufacturing losses, outdates, those kinds of things are relatively inelastic, and they are just, in some certain sense, the cost of doing business.

So we really, if we're looking for flexibility on the supply side, we're looking at donors recruited, and my CEO's quite appropriate approach, I think, to threatened blood shortages is let's hire some more recruiters, and that's what we do. That's a little flippant, but it is, in fact-- as we took on a major tertiary care center that uses 13,000 red cells about a year ago, when I show you our supply data, you'll see that we just increased our collections and took care of it.

The area on the demand side that I think is kind of interesting, inventory in hospitals we're arguing a day or two. I mean, the hospitals want seven days, we want to give them five days, we'll settle at six. There's not a lot of room there.

I think what we don't know is how much of the product that's transfused in this country isn't indicated. I think that over the last four or five years, we've seen some data that is very interesting from a variety of clinical trials that suggest that we probably still do transfuse too many red cells in intensive care units, and you wonder how much more robust the supply could be if this committee, and what filters from this committee, made the application of appropriate transfusion triggers a high priority.

You saw this. This is the ABC stoplight data. But I think that as I looked at all of the supply data this morning that was presented, this is pretty median. What we're seeing in ABC I think is probably what's happening in the Red Cross, and so it's probably pretty accurate.

We maintain our hospitals with a five-day supply in inventory at the hospital, and we keep a five- to seven-day supply in inventory at the main blood center, and in depos at our other fixed sites. So we keep a 10- to 12-day supply of red blood cells, liquid red blood cells, in inventory at all times. These stoplight data suggest that that's not a widespread phenomenon.

I guess the $64,000 question is going to be whether what we do in our system can be replicated elsewhere, and if it can be replicated elsewhere, can it be replicated often enough to relieve some of the concerns that have been expressed here?

So, on my next slide, I want to show you the important slide. It runs off a little bit, but the purple is RBC's made. That means red blood cell, packed red blood cell that found its way into inventory and could have been shipped to a hospital as a licensed product. The yellow line is the red blood cells that we distribute out of our system.

So we have our system of 34 hospitals. That includes a major transplantation and specialty surgery tertiary care center in Iowa City, four other open-heart programs, six or seven oncology services, and then the whole panoply of general hospitals in rural areas that you might imagine.

So we participate in the support of sophisticated care inside our system and, at the same time--I can take this back almost 25 years if you want to see--we export 50 percent of the red cells we produce, so that this year the number out here is almost 40,000 red blood cells.

Jim MacPherson showed you some data from ABC. ABC is 75 independent community FDA licensed blood centers spread around the country, 7 million components. We're now almost a 90,000-unit center. We're in the middle of the pack. We're kind of an average-size center in ABC, and we are exporting 40,000 red cells in calendar 2002, we hope, and we think we're going to make our goal.

Why should we do that? Well, number one, and this goes back to what Ron said--I think he used the word "obligation," and I think, when we're talking about volunteer, uncoerced donors, I don't know about obligation, but at any rate, it's the right thing to do. I mean, from the medical, moral, social standpoint, it's the right thing to do.

Now this was not my idea. This was Dick Novota coming to a community of however big we were 27 years ago, merging two blood banks, Rock Island County and Scott County Medical Society blood banks, and from the beginning, 27 years ago, saying we are responsible for the hospitals we serve directly, but we're also responsible for the rest of the country because there are shortages of blood. These are not new discussions.

Basically, what he sold to our board first, and community second, and what we continue to sell most particularly to our community, our board has learned the lesson over that long period of time, is that the definition of community is substantially larger than the geographic extent of your blood system.

Everybody knows it now. We have people that sing our jingle, and it's a horrible jingle. When we do market research, they sing our jingle back to us from the radio spots, and we have people who hear about us in the media and in our advertisements, and come and ask for jobs because it sounds like a good place to work, and that is 27 years of promotion of blood donation and what we do with the blood that's donated as a community responsibility.

So we have, of course, the other reasons that we do this. It provides a cushion that our system hospitals depend upon. Our fulfillment calculated the Red Cross approach is 100 percent for the last l5 years--100 percent for the last 15 years.

We are reliable, we don't have emergencies, we don't want to have emergencies because we worry about the little boy who cried wolf. How many times can you go to the public with that message? Our recruitment messages are also positive, not crisis, not guilt. We want to talk about their friends and families that are going to survive, not their friends and families that will die if they don't. You do this, and your friends and family are going to survive, and some of your friends and family, by the way, are in New York City, who is one of our larger resource-sharing customers, along with Richmond, and Chicago, and other places that you might imagine.

Economies of scale and proficiency, the more reagents we buy to test to lower our prices, this stuff is all I think pretty transparent. We have better-prepared personnel. We have more personnel. So if somebody that's been there for 15 years decides to go someplace else, we've got somebody that's been there seven years to replace them.

So we have a very stable, low-turnover workforce and are very well-trained because we draw a lot more blood than we need to just to supply the hospitals that we're contracted to, and stable pricing to our hospitals, which recently has resulted in substantially more hospitals than we had, say, two or three years ago.

And then we have resources for new programs, and we were the first center our size to have a blood irradiator. We're the first center in the country that's screening donors essentially exclusively using a computer-interactive audiovisual, touch-screen, donor screening system that controls the process of donor history taking.

We have a flow cytometer, we've hired a transfusion safety officer, we're going to build a new building over the next 18 months. We have a prism sitting in our laboratory--I don't know if that's good or bad. We'll have a NAT lab when our new building goes up, and we're talking about bacterial detection. If we have to do those things, we can do them out of reserves. We don't have to go borrow money. We don't have to raise our prices.

So it's nice. It's enormously fun to collect twice as many red cells as you need.

I didn't mean to put in these effects.

Is there a secret? No, there is no secret. This is 25 years of this is the way we do business. First of all, donors won't give if we don't ask, so that our focus when we're recruiting is the future, not just the current donation or drive.

Our Recruitment Department has been relieved of an enormous amount of work because our Collections Department is responsible for recruiting the repeat donor for the next drive.

65 percent of our donors at our site are rescheduled at the time of an index donation with about a 52 percent show rate for those appointments. 65 percent of the people that come in are scheduled for their next donation and never have to interact with the recruitment department.

There is no mobile blood drive too small almost. And the point there is that a 10-unit drive this month may be a 20-unit drive next quarter, and a 40-unit drive next year, and on and on and on. And we want our collection staff to be busy, so really, for all intents and purposes, there's no mobile drive we won't do at least once or twice to see how things go.

Ron referred to education. In 1979 we hired a teacher as our full-time youth education coordinator, and what he does is go to every middle school and every high school in our system so that every potential donor, prior to being eligible to donate on their 16th birthday and beyond, has seen the blood center twice. Over a period of years every potential donor in our service area has seen the blood center twice. We show them blood typing. We tell them what the blood components are for. We talk about how long they can be stored. We talk about testing, on and on and on, and we think that that's extraordinarily valuable. We can't prove the contribution of that component to our ability to overdraw. We can't prove that any individual component is responsible for X percent, but the youth education coordinator we think is very valuable.

Our recruitment department consumes $10.21 per red cell collected. That's what we spend on recruitment. I don't know about other places. We're in the Midwest, so our labor costs are lower than say New York City, but we think that's a fair amount.

Our marketing efforts are $6 per red cell, and 2-1/2 dollars are paid advertising. We don't like PSAs. Basically they run at 3 o'clock in the morning and you get what you pay for. We want our name and our jingle and our message on the radio at drive time. We want it on in the evening news, and so we pay for it, and we think it works remarkably.

And the last point is a little facetious. It happens to be true, and they are married. But as I told you before, recruitment and collections are--are separate functions only on our organization chart, that goals are established and performance evaluated collaboratively between our recruitment and collections department. There are standards. Our recruiters are responsible for more than 90 percent of goal and more than 17 percent first-time donors, and those sorts of things, but that's done as a collaboration between recruitment and collection.

Can the model be expanded? I know there are blood centers in the heartland that are not doing what we're doing, and theoretically can do it. Remember, this is 27 years in our blood center, so this isn't something that happens overnight. The potential exporting centers need to decide to do it, number one. That's something that happens to level the CEO. Then you have to sell it to your board because the board's the one that votes on the budget. Then you have to sell it to the community. That's extraordinarily important, and you have to spend the money it takes to do it. It's pretty clear cut, and I think the timeline is measured in years, not 25 or 27, but I think 3, 4, 5 years for a center that's kind of happy with the way things are going, taking care of their hospitals, to become an exporter in the magnitude that we are is some period of time.

Chronic importers have to decide to do it. They have to think in the long term. We're not interested in one-year contracts. If we're going to put together what it costs to send 20,000 units to metropolis, we have to spend a lot of money. So we want to talk about 5 and 10-year horizons. That means forging partnerships, and there is a mantra of self sufficiency in our community that maybe is not terribly sensible.

Are our donors different? That's what I hear from a lot of people. They think, well, yeah, you're in Eastern Iowa. There's more pigs than people. Although there are more pigs in North Carolina now than in Iowa I am told, so, Dr. Brecher might. We don't think our donors are different. We think that our blood center's different and has been different for a quarter of a century, and that's the difference.

I would ask the Committee to think about whether this model can be generalized to a wider group of centers outside the urban centers that are suffering worse from the shortages. If the answer is yes, I think it's the responsibility of the government and the blood collection organizations to make the case to those centers who can do it, and to point out to them the enormous benefits to an exporting center.

Questions? Or are we done?

DR. BRECHER: Lou, just for the record, North Carolina's also an exporting state.

MR. KATZ: I'm not going to make any more pig jokes.

DR. EPSTEIN: Lou, maybe you could help me understand a little bit better the relationship in terms of supply stability between an exporting center and an importing center.

You've clearly shown that if you excess collect as a routine policy and with community support, that you can stabilize your primary service area.

MR. KATZ: The happens automatically.

DR. EPSTEIN: Right, that's automatic. On the other hand, you've shown that, well, the excess collections are then the support for other centers that are importers, but it seems to logically follow that if you then had times of excess need, be they disasters or fluctuations, that the units available to export must necessarily decline.

There is a zero sum gain then, right?

MR. KATZ: Yeah, we carry--well, first of all, let me tell you that our exporting is done with contracts and long-term commitments, and how many units of what type per week, and in the last 5 years we've missed one shipment. So that our ability to recruit, retain and draw donors has been enough that since our planning horizons run out on long-term contracts, we've been able to fulfill the commitments that we've made to the New Yorks and Richmonds and Chicagoes.

DR. EPSTEIN: Right. But the thing is that those importing centers probably are not 100 percent dependent on your exports.

MR. KATZ: Oh, absolutely not. No, we cannot take care--

DR. EPSTEIN: Right. But if you start to look at it from the national perspective or the global perspective, an importing center is necessarily vulnerable. It just depends where the excess needs are occurring, because they're always sort of second in line. That's one issue that I'd like to--

MR. KATZ: Yes, I think it's always bumpier on the importer's end.

DR. EPSTEIN: Right.

MR. KATZ: I don't argue that.

DR. EPSTEIN: And then the second issue is that if you accept that logic, then the only way to stabilize the whole system is for everybody to be an excess collector, and then the implication of that is that the wastage rate would have to go up dramatically.

MR. KATZ: Well, it may be that our wastage rate is a little low in some areas now.

I will tell you that I'm not sure it makes any sense at the cost of doing business in New York City for Bob Jones to try and be self sufficient. I can tell you that I can sell him a red cell for $130, and he can't make a red cell for anywhere near that. If everybody did what we're doing, we'd be out of business. They all tell me they can't do it, that we're an aberration. I think that there are subsets of centers outside of major urban areas that can do exactly what we do and augment the blood supply. It won't be perfect, but be better than it is.

DR. JONES: Can I make a comment?

DR. BRECHER: Yes. Come up to a microphone, Bob.

MR. KATZ: Bob and I have had this discussion.

DR. JONES: We're very happy that Lou and others like him do a good job and we're able to, at least in some transition period, have a good supply from them.

One of the issues we face is our type mix of transfusion and how we're going to match that with blood that's coming from parts of the country that don't have nearly the ethnic diversity that we have. I mean it's not just Type O, AB. There are all kinds of subtleties in our patient population that really are better matched from the ethnic diverse population that we have as donors or potential donors.

I was interested in Peter's comment because we have a big push towards Hispanics as well. It's very, very difficult. It's a long haul, but it has to be done in order to really have a blood supply that meets the needs of your local population.

MR. KATZ: And I think--I don't have every answer here, but I think that we can put an--you want more A's in your contract, talk to us. We'll recruit A's.

DR. JONES: I don't think--A's I don't think are the issue.

MR. KATZ: Well, you know, just it's where you tell us and let us take a shot at it, or if it's not us, Amarillo, that does not export to the degree that we do, has a huge Hispanic population. Why isn't Amarillo helping you guys out in a proportion like we are? I don't know. I think there's a million reasons, and mostly it's inertia. This is the way our little blood center out in the middle of nowhere always ran. We take care of our community, and that's what we're about. There's all kinds of reasons.

I think that these partnerships and more of these kind of partnerships and more activity of this type by heartland center, for lack of a better word, would make your life a lot easier, and will work on the details of type distribution.

DR. DAVEY: I just think, along the points that I think have been made about the vulnerability of importing centers--I work in New York with Bob--as Bob said, we're very grateful that people have stepped up to the plate and helped out at least our center, and it's been invaluable to us. But I think it is key that exporting centers--and as Lou and others have said--have their primary responsibility of course to their local base. And if the national blood supply continues to erode as it seems to be eroding in the past several months, we cannot rely on imports to sustain our operation. It's critical, and I think Bob has indicated that we penetrate and engage our ethnic communities, and continue to increase our own donor base.

We can't rely on imports all the time. It's unreliable even with the full intent and commitment of a contract, we know that exporting centers have their own priorities, and that's their local communities first.

DR. BRECHER: Okay. Rajen, one last comment.

MR. DALAL: Just a couple of questions regarding your exceptional sort of experience with recruiting. First, just for information, the 10.21, the $10.21, is that the full--fully burdened, and does that include the $6.00 of advertising?

MR. KATZ: No, that's separate from the $6.00 of advertising.

MR. DALAL: So it's a total of 16.21. And is that--does that include overhead or is that just--

MR. KATZ: That's salaries, materials--yeah, it's pretty close to everything.

MR. DALAL: Okay. At some point it would be very interesting to know what the cost is in some of the other parts of the country so we can compare, because there's an investment opportunity here, so we should think about that. The second is, what is your experience with the sort of marginal return on hiring a new recruiter? Every time--I mean if you were to add one or two or three, would they continue to be able to bring in new donors pretty much at the average rate of your existing recruiters?

MR. KATZ: There's a learning curve. There clearly is a learning curve. We don't--the only time recently that we've brought in new recruiters kind of cold and quickly, was when we took on the University of Iowa Hospitals and clinics. It was kind of an opportunity that came along quite quickly, and we really needed to ramp up and we did. So our--otherwise, this is long-term planning and we have plenty of time to train people. And, you know, our training is, this is your job, these are your goals and be nice. And I think be nice is the important thing.

We ask our donors every year, "What was your experience like at the blood center?" And we want them all to say, "It was fun. It was neat. I felt fulfilled. I was treated well. And that includes our recruiters. I mean we ask them about that. So it's not rocket science to recruit donors. You ask. And you ask a lot of people. You saw--who showed us the 12,000--Rich Counts showed you 12,000 to get 1,000 in the door, a little less?

MR. COUNTS: 2,500.

MR. KATZ: 2,500, yes. And we think--I think our return on telerecruitment, cold calls a little lower than that even. It's not the most exciting work in the world, and so retention becomes an issue, but we don't have a hard time keeping our recruitment staff up to snuff.

MR. DALAL: And just a last point of information. Do you do a systematic survey of your donor base to understand their attitudes towards blood donation, particularly the younger donors?

MR. KATZ: The younger donors, we haven't done one in a couple of years, and we're working on one now because we're very interested, as that population distribution shifts, as you were shown, we're asking ourselves, are we right now living off the baby boomers? And we think we are a little bit, and so we're trying to bring in, I don't know what it is now, Gen-X, Gen-Y and there's another one below that. So we're particularly interested. If somebody donates with us in their 20s, they're going to donate with us in their 30s if they're still around and we haven't deferred them for one reason or another. So we do enormously well in the high schools.

But then the high school kids, half of them go off to college and half of them go into jobs and stuff. And so what we're interested in is the high school kids that stay, do we keep them? And we don't know the answer to that.

DR. BRECHER: Okay. We're going to take a 15-minute break.

[Recess.]

DR. BRECHER: Dr. Jones from the New York Blood Center has asked for 60 seconds to make one additional comment. We'll let him do that. Then we'll move on. So let's reconvene, and Bob Jones from the New York Blood Center.

DR. JONES: Now that I'm off my soap box on CJD, I just wanted to bring up a subject which is that Mike Busch and I have talked for about a year about putting together a metanalysis study to try to determine what the actual potential of the nation's donor base is. There's lots of information out there available from different blood care organizations, certainly Red Cross, ourselves, BSI, many other ABC Centers have done market research to look at all of the events that take place between the time a donor thinks about donating blood to the time they walk to the door to register. That's probably the most difficult sector to look at, but there is market research available on that. Then all the events that take place between the time the donor is at the door and registered until the time a bag of blood rolls out, those events are very well defined and highly measured, lots of information available. That's sort of Section Two.

And then all the events that take place after blood enters a hospital and is inventory that impact on the total available supply is Section Three.

So we're putting together basically three metanalyses of these sections to try to determine, if we can, what is the total potential blood supply for the United States given all the criteria and so forth we have right now. We had a meeting in Washington, or actually it was in--where was that, Jay, the meeting we had? I can't remember where that meeting was that we had. Yeah--maybe it was in Bethesda. Wherever it was, it was at an FDA facility. And a couple of folks from FDA were there, and ARC and ABC, and it's a very interesting study, and I think there's lots of energy and commitment from all the organizations to work together and share information. And so hopefully maybe in another six months to a year we'll have some better information regarding that important question. Thank you.

DR. BRECHER: Thanks.

We're now going to hear about lessons from the Health Resources and Services Administration on organ donor initiatives, if we have the technology up and running.

MS. GANIKOS: Good afternoon. I'm Mary Ganikos, and I'm Chief of the Education Branch, Division of Transplantation in the Health Resources and Services Administration. And I am going to share with you today some of the things that we are doing to increase organ and tissue donation, and my understanding is that you all are thinking about ways that you can try to increase blood donation and maintain blood donors.

Now, there is somewhat of a difference in the types of things that--strategies that we might use because in organ donation, that's a one-time thing. We're not trying to maintain that donor once they've donated their organs.

But without exception there probably are a number of similarities and types of things that you could consider, and I'm hoping that those strategies we'll be sharing with you will trigger some thoughts.

I would like to share with you first the problem in organ donation. I'm sure you're intimately familiar with the problems in blood donation. In organ donation, the top line that goes up is the number of people on the waiting list, that actually now it has exceeded 79,000. It's more than 80,000. The middle line is the number of transplants that were performed last year in 2001, about 24,000 transplants. And the red line, the bottom line, is the number of donors that we had that year, and that includes living donors as well as cadaveric donors, or deceased donors.

Last year, in 2001, for the first time the number of living donors surpassed the number of deceased donors, and the number of living donors is growing fairly dramatically. A big difference of course in living donation and in deceased donation is that you get multiple organs from a deceased donor. And that is why you can see, even though we had only 12,000 donors, we were able to do 24,000 transplants. But still that's a drop in the bucket compared to what we need to, and annually about 6,000 people on the waiting list for organs died because there are not enough organs to go around.

So that was the problem. And where--in organ transplantation and donation, where does the problem lie? Where are we missing the boat, so to speak? It's basically in the general population people's intent to donate, whether they want to be a donor, whether they have declared themselves to be a donor, whether they identify themselves as a donor, in the hospital whether the hospital staff recognize when a donor becomes available or a potential donor, so that it's acted upon, and then whether the family give consent at the time of death for a potential donor.

And we're finding that when asked only about half of the families give consent, so this is an important issue for us. And those three items set the stage for the types of activities that we do and where we target them, so we basically target at the individual or the general public and some groups therein. We target the hospitals and we target families.

What are we doing about the problem? One of the main things that we're doing now--and let me say that we have been promoting organ and tissue donation since the early '90s. Only more recently since our budget has expanded somewhat have we been able to do it on a fairly large scale, "recently" being in the last four or five years, but right now we have a Secretary who is very, very committed to organ, tissue, marrow and blood donation. When he came to HHS he was a self-proclaimed advocate for donation, and that has been a real find for all of us.

And I want to say that whenever we produce materials--and those of you around the table have a packet of information, not everything that we do in this initiative, but some of the things. And as you will see, every time we say what we're promoting it always is organ, tissue, marrow and blood donation.

We also do related community outreach programs that are not necessarily part of the Secretary's campaign, but they are related because they all focus on increasing donation, and we have a research and evaluation program because we feel that we need to learn what works, so that we don't keep doing things that don't work.

These are the five components of the Secretary's initiative. The first and probably largest component is called the Workplace Partnership for Life, and in that--well, let me just go through all of them first. Then we had a donor registry forum. I'll explain in a minute what a donor registry is to us. A National Donor Medal, a curriculum for driver's education and a model donor card.

And this initiative was launched in 2001 in April, and that was within 100 days after Tommy Thompson became Secretary. He was emphatic that he was going to launch a major national campaign within his first 100 days, and he certainly did. There were 18 corporations and organizations that joined his Workplace Partnership for Life as charter members, and the purpose of the Workplace Partnership for Life was to recruit organizations, unions, corporations, all kinds of agencies around the country into the partnership, and with the idea that they would educate their members or employees about the need for donation, and conduct drives, whether it be a marrow drive, a blood drive, an education program about organ and tissue donation, et cetera.

We had, after one year of this, about 1,000 partners, about 1,200 partners. Tommy Thompson told us we would get 1,000 partners in a year, and so we did. And he now has told us since we were so good at getting the 1,000 he wanted us to get, that now we shall get 5,000 by next year. So we are moving with that.

We have a lot of partners. These are some examples, and they're large and small. We have partners as large as General Motors and Proctor & Gamble, and we have partners as small as the Cleaning Cubans of Jacksonville, Florida. But in every--every organization is important in this initiative. We really feel that most of the adult population in this country goes to a place of employment or a place of an educational institution or something of that ilk, and that is an ideal place and a way to reach those gatekeepers and to get them to help us educate others.

A donor registry in organ donation generally is something that is housed by a division of motor vehicles at the state level, and basically it lists the number, the people who want to be donors. And we found that that was an important venue because there's no other place that we could think of where people routinely go every so often as you to a division of motor vehicles.

Now, a donor card is something generally that people carry in their wallets, and often those are not available at time of death. Many donors come from car crashes and many traumatic accidents, and sometimes the highway patrol take the wallet away, and it ends up with them or in the hospital safe, or maybe it's never found. And so having a registry so that when a person dies and a family is asked if they want to donate the organs, most families, the first thing they say is, "Gee, I wonder what so-and-so would have wanted." And so having that information available is important to use. So one of the other components of this campaign was to have a donor registry forum, and discuss a number of issues related to donor registries.

The Secretary also learned to create a medal, a visual symbol that continues to educate the public and honors donor families for--and donors for their charitable acts. And we have recently developed and put through our channels a proposal, a legislative proposal that we hope will end up in January in Congress, asking them to determine whether it would be possible for us to initiate a congressional medal for donors. It has not been decided yet finally, to my knowledge, whether these are organ donors deceased or living also, or organ, tissue, marrow and blood donors that--well, nothing has really been decided because it has yet to reach Congress.

We're also developing a high school curriculum, and this was something the Secretary very much wanted to do. It was done in Wisconsin when he was there, as was a medal. Wisconsin has a medal that they give to their donors. But a curriculum that can be--it started out as a driver's ed curriculum for high school students, and we've enlarged that to a curriculum that can be used in any high school class to teach organ and tissue donation. And so we were working on that.

The Secretary wanted a donor card that would be a legal document in all 51 jurisdictions including the District of Columbia, and so we had the American Bar Association research the requirements in those 51 jurisdictions and this is the things that you see on here, the two witnesses, donor's signature, et cetera, work in all the states.

Now, I'd like to share with you some of the related community outreach programs that we are doing at--at the Division of Transplantation. And I would like to say that much of the work that we do and the initiative that I was just talking about, and much of the work that I am going to share with you now is headed up by my colleague, who has joined me here today, Joy Deamis (ph), and Joy, if you would just raise your hand?

And Joy has also worked in the marrow community at NIH. I see someone shaking his head. You must be Dr. Klein. Okay. She said you were here.

And so Joy has been able to work in both of those areas, which has been a real plus for us.

One of the things that we believe in developing campaigns and in trying to promote large-scale behavior change in the American population, is that people need to hear the message time and time again from various institutions in their community and various people in their community that have credibility for them, and repetition is a real key. So we try to plan a variety of projects that will promote this message in different venues.

Some of the things that we do, there are a number of nationally recurring days or weeks in the organ donation community, and so we always have projects that evolve around or revolve around these weeks or days, and we really spend a lot of time focusing on those. For example--and some of these were in existence when we came into the Division of Transplantation, and others we developed. For example, National Donor Sabbath was developed by the Division in collaboration with the transplant community. It's a three-day period, Friday, Saturday, Sunday, two weekends before Thanksgiving, where we ask clergy to help us promote this message from the pulpit and through the bulletin, and we developed a kit that we could send out to our local transplant organizations throughout the country, where they could--they had sermons that we had collected and copied and different articles about how different religions view donations and so forth, but basically giving a turnkey product to our helpers in the community, so that it makes it easy for them to do what we're hoping that they will do, and we found that obviously we can't go this alone. That's why we're recruiting corporate partners now, and we can't--we need our colleagues in the community throughout the country to work on all of these things with us, so we have quite a collaborative effort.

National Health Care Decisions Week, is generally the third week of October, and we developed that project with the American Bar Association. They had a project going that they were piloting at Valparaiso Law School and in that community, whereby the attorneys of the law school students in this case, would go out into the community and give lectures on things like end-of-life decisions like advanced directives and living rules and so forth. And then they would prepare those documents pro bono for the people who attended those seminars. And so we piggy-backed on that and included organ and tissue donation in National Health Care Decisions Week. And I would think that that would be something--I can say that this has been ongoing now for several years, and blood was not included in that, but certainly we would be very willing to try to broaden that, or any of these activities if we could work with you and help your community.

We have a program every year, every two years now--it started out every year for eight years, and we've gone to every two years because it's grown so much--to recognize the nation's donors, and this is conducted in Washington. It's the Federal Government's way of saying thank you. We have--it's very federal looking. Last year we had the President's own Marine Band present the colors. It was a 100-person band that played some of the music. And people come from all over the country to attend this program. The most I think we had in attendance was close to a thousand a couple years ago. We always try to get key speakers who are going to get some media attention too, and continue to draw attention to the need for organ and tissue donation. We have had a number of key people from entertainment, but also from politicians and HHS people. Tommy Thompson was our key speaker last year, and Ken Moritsugu who is the Deputy Surgeon General, has been our moderator all these years.

We produced and I was planning to bring a box of films for you so each of you could have one today until my secretary put it together and I looked at it and I said, "Oops, I think we'll mail them a copy." It was a bit heavy. But we put together, because we believe that media plus community grass roots activities are the key in changing health behavior. If you're familiar at all with any of the health behavior literature, some of the seminal work in changing health behavior was done by Stanford, some research studies that showed that really media enrollment is not sufficient, and grass roots alone is not sufficient. The two together are a dynamic couple and you need both.

So we were planning to promote some things on television by making this film called "No Greater Love." I don't know if any of you have seen it in your communities. It's being shown now on PBS stations around the country. It's a 60-minute documentary, and I have a 15-minute version as well as a 2-minute clip. But I will be glad to send to all of you at the table--and we've already worked out the arrangements for that--you'll get a copy of the 60-minute version.

We're also, this coming FY, beginning in October, we will be sponsoring traffic ads on radio stations, and we'll also be sponsoring some ads on the weekly nationally broadcast NCAA football game an also BET radio.

There's another group in the transplant community, the Coalition on Donation, that does most of the television advertising, so we're trying to supplement that with radio advertising. So we're trying to supplement that with radio advertising.

The documentary that we prepared, we had a premiere of this documentary that Secretary Thompson hosted on April 9th at the Reagan Building, and we invited all of the partners in the Workplace Partnership, all that were partners at that time. We've recently learned that it is needed, even though it's only been out and being broadcast since April 9th, into the top 10 of what they call one-time offerings on PBS, and that means not a series. PBS has an exclusive on broadcasts for this for the next two years. It was not shown on one national date. It was sent out by satellite feed to PBS stations, and they could download it if they wish. And they can show it if they wish. They can broadcast if they wish. But it has now made it into the top 10 of one-time offerings being shown on PBS in the last 12 months. So I look forward to seeing how farther up it gets in the top 10 when it's been out there for 12 months. But it's really, I think you'll see, quite an outstanding film. We were very pleased with the results of it.

And we target other gatekeepers in the community. We target the professional community, as well as for us what would be the lay community, which doesn't mean they're not professional, but they're just not transplant folks or related. We have a project going with the AMA to try to identify reasons why physicians don't become more involved in donation, and then they will be giving us a white paper on strategies to overcome these barriers.

We developed research and developed it with the National Council of State Legislatures and the Council of State Governments, a substantial document that was at the time--it's a year old now--but it was a comprehensive resource on state legislation and bills and policy that affect donation, and we had little charts on there. One of the things that NCSL told us was that states like to compete with each other, and so if we put some charts on there and show that Florida is doing all these things, then Georgia may look at it and say, "Maybe I'd better do some of these things too."

So we were hoping to stimulate some competitive juices with this document. But we have actually just filled out some papers today to reprint because it's been quite popular.

And we focus on hospital staff, and as you may remember, one of the places where we lose donors is when hospital staff don't recognize a potential donor and call in the transplant community.

Then we also focus on education, institutions and students. And we've done for the past couple of years a college campus campaign based on the theoretical model of behavior change, and we are in the process of preparing a how-to book so that it can be replicated in other schools across the country. And this coming year we will be focusing on getting into the elementary and middle schools through the Internet.

And then we also pick out special populations to focus on. We're developing this year, we will be developing, a 30-minute film similar to the one now on PBS, but that focuses exclusively on minorities, so that it can perhaps be shown on some of the minority television programs but also in other ways such as local educational efforts. We have a project with the Congress of National Black Churches, whereby we are trying to educate their leadership about the need for donation.

We're developing--and these should be out hopefully in the next couple of months--little health passports that look like a passport, and that don't necessarily act like a passport. You couldn't go overseas with it, although you should take it overseas, but it's a place to record all your health information and your doctors' numbers and your families' history on health issues and so forth. So you have everything all in one place. We have one for Hispanics and one for African-Americans, and then of course there's a section on organ and tissue donation. And this year we will be focusing our campaign efforts on older Americans and Native Americans, two populations that we really haven't focused exclusively on yet.

For the campaign we developed a symbol. Secretary Thompson wanted something with a heart in it. The green ribbon had traditionally been the symbol of donation and transplantation, so he wanted to combine the two, and our graphics artist came up with this, and we think it's quite lovely. There should be a pin like that in the folder that you've received. We have a website at organdonor.gov, where we put lots of different kinds of information, but we also post information about what partners are doing, and we feature different recipients and donors and rotate them on a monthly basis. And we're in the process of printing, hopefully next week, some kits that we've made for the employers and the employees that sign up in the initiative. We have bumper stickers, pins, posters. Materials are always an important part of a campaign.

We have a grant program, and that just was started in 1999 when our budget got sufficient that we could have a grant program, and our objective basically, as I said earlier, is to learn what works in increasing organ and tissue donation, so that we put our efforts in the places that work, that give us the best results.

And any kind of organization, as long as they are private not-for-profit can apply to this grant program. Unfortunately, there's a fluke in our legislation that doesn't allow us to fund public institutions, so we cannot fund public universities or units of government, local government, but it's private not-for-profit. But the grants must all include organ research. So actually a blood donation center could indeed apply, but they would have to focus on organ donation. They could also focus on blood donation at the same time, but they could not focus only on blood donation.

These are the sums that we have awarded in the years of the grant program. We haven't awarded this year's yet, but we figure it will be about 3 million for new starts. Now, the sums that I have up there are for three years, so 13,000 in 1999 was for three years. Our grants are three-year projects.

The original grant program focused on social and behavioral efforts to increase organ and tissue donation, and just this year we began a clinical grant program that focuses on increasing organ donation. In February we plan to have a showcase to share the results of the '99 grants with anybody who would like to attend.

And that again is our little symbol that we promote on everything that we do, and if you--I guess--back up. Well, anyway, the end.

[Applause.]

MS. GANIKOS: Questions?

MS. GANIKOS: Jeanne?

DR. LINDEN: For the donor cards, are there any states or areas where those are actually used as consent?

MS. GANIKOS: There are, and it's an increasing trend in the transplant field. A number of states have passed legislation where a donor card or a driver's license or a registry indicator serves as what we call first-person consent. Traditionally we've looked to the family for consent, but a number of states, including Virginia, has passed laws that say that the transplant people are in violation of law if they don't take the organs if they're usable from a donor who has a donor card or a driver's license indicator, even if the family objects. And there are other states that do that as well.

DR. LINDEN: Do you happen to know how many states, and is there a list somewhere that's available?

MS. GANIKOS: I don't know off the top of my head how many. I would guess at this point 7 or 8.

Joy, do you have any idea?

[Comments off microphone.]

MS. GANIKOS: There are 7 or 8 I would think that have passed this kind of legislation, and we could probably find a list for you if you contacted us, or we could develop a list for you.

DR. BRECHER: Okay. Thank you, Mary. That was very helpful.

We're going to change topics briefly, and move on to a brief update on the West Nile virus, and we're going to hear from representatives from the FDA and from the CDC. Jesse Goodman from the FDA will give the first--oh, it will be the reverse? That's all right.

[Pause.]

DR. MARTIN: Unfortunately, my CD cracked this morning, so please pardon the delay here in terms of getting my hard drive up.

My name is Tony Martin, and I'm with the Division of Vector Borne Infectious Diseases, which is one of the divisions of Centers for Disease Control, and we're located in Fort Collins, Colorado. This is the first time that anyone from our division has come to talk with you, but Drs. Mary Chamberland and Judy Gerberdine thought it was very important to give people an update so that rumors don't start and just to let you know what's happening with regard to West Nile virus, because I'm sure a lot of you are aware that there are some recent changes.

First I'm going to talk a little about the virus. Then I'm going to talk about the pattern of viremia very briefly, the nature of infection, the antibody response, a brief overview of the epidemiology, because it's important to understand that this is a rapidly expanding geographic zone of activity, and it's going to have some real implications. And I'll speak a little about avian mortality. It always seems funny to physicians to have a physician talking about blue jay deaths and things like that, but it is actually pretty important. I'll talk about human illnesses with some emphasis on what's happened this year, and then I'm going to talk about an investigation of some West Nile viral diseases in some organ transplant recipients that has been heavily investigated over the past four days.

Matter of fact, working with Mary Chamberland for the past four days has just completely wore me out.

[Laughter.]

DR. MARTIN: Not getting much sleep.

West Nile virus is a flavivirus, which is a huge family that does include some human pathogens. Most of the human pathogens in the flavivirus are arthropod borne. This will be the only group that will point out to me that of course that hepatitis C is a flavivirus too and that is not arthropod borne.

West Nile virus is related to Yellow Fever and dengue, and the reason I want to bring that up is Yellow Fever and dengue are two flaviviruses where the viremia, the virus in the blood, can achieve very, very high levels, high enough to infect mosquitoes and then subsequently infect another human being. They are the only two flaviviruses where that occurs, and people have been looking for transfusion-associated transmission of Yellow Fever and dengue for many, many years, and no one has ever found it. And then I should point out of course that West Nile virus is distantly related to hepatitis C.

West Nile is part of the Japanese encephalitis sero complex. We have had another flavivirus in this country that's been identified, recognized in the United States since 1933 and that's St. Louis encephalitis virus. Both of these viruses are primarily bird viruses. Humans play no role in terms of the amplification. We play no role in terms of the reservoir. We're what's called incidental hosts. Some of us can become very ill when we get infected and sometimes die.

West Nile virus was only recently introduced into the United States. To the best of our knowledge, there has never been a case of West Nile virus in the United States until 1999 when it was introduced in New York City.

For all extent and purposes--and I have that all in quotation marks for reasons that you'll see here in just a bit--all infections are due to mosquito bites. There have been well-documented lab transmission cases in which there was percutaneous injury, even inhalational challenge that resulted in West Nile infection, but for extent and purposes, this is a mosquito-borne disease.

The incubation usually comes about 2 to 6 days after infection. It usually starts with a mosquito bite as I noted up here, and after the mosquito bite there's usually local viral replication within the regional lymph nodes. It's a little unusual in that there's probably two ways of viremia, one a very, very low concentration viremia, in which the virus spread from the regional lymph nodes and seeds the liver and spleen, where it undergoes a lot of replication, and then there will be a second wave of viremia, and that usually results invasion of the central nervous system to some extent.

Now, some people will just have a mild invasion, people that have fever and a headache. Others may develop aseptic meningitis, and some will develop encephalitis, and there are host factors that cause that.

The secondary viremia is the one that has the highest concentration within humans, although as I'll point out a little later, it's not very high at all, and it usually lasts from about 5 to 6 days. There were lots of studies done in the '50s in Israel when West Nile virus was a large problem, in which they clearly showed that the peak viremia is about one or two days prior to illness.

They moved people into areas where--not purposely--but they moved people into areas where there was a lot of West Nile virus transmission, and they just bled them every day, and put that serum into neonatal mouse brains, and they showed that almost all the viremia is occurring before people are ill. You can still get some on the first day of illness, sometimes on the second day. There have been isolates after 4 days later. But really the viremia that I think everyone would be concerned about in thinking of a transfusion related event is occurring before people have their illness.

Now, we have had the opportunity to be working in many communities this year. As you all know, there's just been many, many human cases. I think we're going to be pushing close to 800 reported human illnesses with the reports that come in today. And we've gotten involved in looking in a lot of communities, looking at some what we call West Nile fever studies. In those studies we have established a presence, and we are taking blood samples from people who come in with fevers and headaches, and we are trying to show both the proportion of those people that have illnesses due to West Nile virus, as well as to try to demonstrate that there is a measurable viremia. I mean the question is still out there whether humans can infect mosquitoes that can subsequently infect humans. And so we're continuing to look for that.

I will give you a news flash. This isn't the news flash you're looking for, but this is that we have not been able to demonstrate any measurable viremia. All of our results have been intermediate low, and we just haven't been able to show significant viremia. In fact, since 1999 when West Nile was introduced, we've had only one human isolate. That was just a few weeks ago in a person who was simply incapable of making immunoglobulin, and that is the only human isolate that we have since 1999.

There are many human isolates in Israel over the past three years, where they are having similar outbreaks, and we're working with them now to find out what they're doing that is somewhat different than us.

When all is said and one though I think we're talking about a concentration of virus in general, about 10 to the second or 10 to the third virus per ml., which is not enough to infect a mosquito. Occasionally we do see people that will get up to about 10 to the fourth back in some of the older studies.

Are primary diagnostic method, when we talk about West Nile virus, has been to measure IgM antibody to the virus, and about 95 percent of people will develop IgM to West Nile virus by about the eighth day of illness. Somewhere about 85 to 90 percent are developing it by the fourth or fifth day of illness. And as West Nile virus IgM titer goes up, the level of viremia drops rapidly, and so these are the important things to think about here in a bit when we talk about how we know somebody's got a West Nile virus infection occurring.

I'll come back to these. This is just talking about some Tag Man and culture studies, and I'll come back to those if there are questions about that.

Now, the epidemiology, human infection rate correlates very closely with the mosquito infection rate in Culex mosquitoes. Infection rates are roughly equal across all age groups. This was best shown in 1996 in a large outbreak of West Nile virus in Bucharest. But the illness itself primarily does affect people that are 65 years and older. So the infection is equal across all age groups, but in terms of the manifestation of disease, it is primarily older people.

In general I think that you would have to say that the infection rates, even in areas where birds are literally falling out of the tree around you while you're doing the sero survey, is relatively low. And the first sero survey that was done was in Queens, where the team gerrymandered a population to include the hottest of the hot zone, and they were able to show that in a worst-case scenario, that about 2.6 percent of the population was infected in the summer of 1999 with West Nile virus.

The next year we did three sero surveys, and literally the crows were falling out around us as we were walking through the neighborhoods. They were staggering across the street. And it's a very, very intense epizootic, and we were able to demonstrate zero percent infection in Connecticut, 0.1 percent in Suffolk County, New York, and 0.4 percent in Staten Island, New York. These are very, very low infection rates.

If you look at some of the recent St. Louis encephalitis outbreaks, 1991 in Pine Bluff, Arkansas, we're talking 11 to 12 percent of the population will become infected in a year. So we're nowhere near that.

So the infection rate is low, and in fact, very few of those people ever develop disease. And so what we have managed to do is we have developed a ratio of cases of meningoencephalitis to the number of infections, and for about every 150 to 200 infections, you'll get about one case of meningoencephalitis, and about 20 to 30 cases of West Nile fever. Well, that means there's about 120 to 180 cases of asymptomatic infection out there, and we have no reason to believe that the viremia patters is any different for people with asymptomatic infection than we do for people with meningoencephalitis.

Another thing that I wanted to point out here is that if you look at the cases of meningoencephalitis, they are older people. Some of them have a lot of co-morbid disease, and that by far the asymptomatic infections occur more frequently in younger people. They don't develop any manifestations whatsoever, which of course may have some implications with regards to your blood donor population.

Let me just quickly show you the epizootic. These were the 28 counties that reported West Nile virus infected birds in 1999. That doesn't show up well, but that is for 2000. There were 136 counties. This was through May of 2001. Last year there were 11 counties. Through August there were 200 counties. Through the end of the year last year--and there were birds going all the way up till Christmas--there were 328 counties reporting at least one West Nile virus infected bird. That meant that there's infected mosquitoes there. These are not due to migration in from other counties. These are due to local transmission with infected mosquitoes that may bite human beings.

You can see that last year we actually involved a lot of the Midwest, and that's going to be important here in just a bit.

Okay. Let me just show you what happened with the humans that year. In 1999 only 6 counties reported cases of West Nile virus infection. In 2000 there were 10. August of last year, one year ago, there were 22 counties. This year there are 28 states. This is all we had last year, 39 total counties. Just to run that down again, there were 62 cases reported in 1999, only 21 cases of illness reported in 2000, and 66 cases reported last year. We thought this was a lot until this year.

And I should take the opportunity here to look at the onset dates for the cases in 2001. We're talking about people who had onset illness all the way into December. There's a real potential here for year round transmission as we get into some of the Southeastern and Southern states.

Now, this is a summary of any--having any West Nile virus activity. In fact, we'll go right to the bottom row. 2001 there were 358 counties that reported any West Nile virus activity in their counties, and again, as I mentioned, all the way up through Christmas, and it starts right after the spring thaw. There's real potential for a year round transmission. So where are we now? Unfortunately, I was still building this slide set this morning, and I had to go onto one of our partner's websites, and it doesn't transmit very well, and I apologize for that. But what I do want to point out is that those areas where there were lots of birds last year, we now are having lots of human cases. And they kind of warmed up the place. We have hundreds of cases coming out of Louisiana, hundreds of cases coming out of Illinois. We are approaching 200 cases in Mississippi. Texas has many cases, Missouri. And if you remember, if anyone in here is old enough to remember 1975 and the large St. Louis encephalitis outbreaks, we're just coming into what people might call the shank of the evening, that first week of September when so many cases can--

VOICE: [Inaudible, off-microphone.]

DR. MARTIN: These are both. These are illness. Have I been using them interchangeably? See what Mary does to me? She just works me too hard.

All right. As of yesterday, last night, 41 states report any West Nile virus activity in animals. 28 states report human West Nile illnesses. There's 737 West Nile illnesses. Two-thirds of those, by the way, are meningoencephalitis, and it's probably going to be higher than that. What happens when you get an epidemic of course is people start reporting West Nile fever all the time too, and there have been 40 deaths.

Now, if we take that 150 to 1 or 200 to 1 ratio, this means that there's at most probably about 150,000 infections in 41 states where there's activity, so it is relatively rare in terms of infection, and the real problem of course is that 80 percent of these infections are going to be completely asymptomatic.

So what are the problems? We have widespread and spreading activity. We have activity that persists in some areas for year after year. There is one county in New York that has had human West Nile infection now for 4 years running. It's a relatively low human infection rate. Peak viremia occurs prior to illness. Most infected persons are asymptomatic. Most symptomatic infected persons are older. And the worst thing is that it's kind of unpredictable in terms of sporadic or epidemic infection patterns.

So this is why I'm here, and that's to talk about some West Nile virus infections that have been recently described in organ transplant recipients.

In late July of this year an eventual organ donor was in a motor vehicle crash. This person is a resident of the Southeastern United States. This person was well up until the time of that crash. This person was taken to a tertiary care center, where during the first 24 hours there were few surgeries and lots of transfusions. All told there were 63 donors who contributed products that went into this person. After that first 24 hours it was clear that unfortunately that this donor was brain dead, and they began to prepare her for organ donation.

Four organs were recovered. They went to four recipients. In late August we were told that 3 of the 4 recipients developed West Nile encephalitis and actually now I can tell you--because I was embargoed till 4 o'clock--that all 4 of these recipients have in fact developed West Nile illness. 3 of them developed encephalitis. The fourth person here in line, the testing is being announced right now in Florida, that this too is a West Nile infection and she had a West Nile fever. So 100 percent of the organ recipients developed West Nile viral illness, 3 encephalitis and 1 fever.

Two of these cases had been discharged home after transplant and before their illness onset. They are residents of the Southeast United States. They're living in areas where there is quite bit of mosquito activity and quite a bit of animal activity. So I guess it always can be discussed as to whether they got their infection from a mosquito bite. Seems unlikely. These two cases, by the way, did not receive any transfusions before the onset of their illness. They were both the kidney recipients and there was very little--there were no blood products used in terms of their surgery.

The other two cases had no outdoor exposure before their illness onset. They were transplanted and then they were in the hospital till they became ill. They too live in an area where there is some West Nile virus activity, although not very much at this time. And they did receive quite a few transfusions.

This is, after an exhaustive search by the Georgia State Department of Health, the Florida Department of Health and CDC, we were able to find two samples from the organ donor. One of them was a very, very small amount of early serum, and that early serum, we were unable to demonstrate that there was any West Nile virus antibody. It was also negative for PCR. So to the best of knowledge, there was no West Nile virus in there.

Since that time we have identified another source or serum, an we will be doing testing on that as well.

We then found a late serum, and again there was no antibody to the West Nile virus, but in fact we did show that there was a low level positive PCR result for West Nile virus, and that has been repeated several times. So either this person was incubating and they finally got up to a particular threshold, or they were infected sometime between the early and that late serum.

Well, although I've said that most West Nile virus infection occurs as a result of mosquito infection, we have to consider that perhaps transfusion played a role in here. And the American Red Cross, FDA, the state health department, CDC, we're all working very hard to investigate this, to see just what was the role of any transfusion products.

American Red Cross has located all the pigtails from the blood donations, at least for their Southern Region donors, and they're working with the other regions to identify if there's any of these segments left so that we can be doing some testing. They've identified all the in-date co-components that are out there, and are trying to take control, if not possession, of those products. They've worked very closely to identify all the donors that gave blood products to the organ donor, and they're identifying the recipient's co-components, because what we're going to do is we're going to test the organs and the blood samples of the organ donor to try to estimate--I should have put "estimate" here in quotation marks--we're going to try to really make a good determination whether this person was infected at the time of the crash or whether this was an infection that subsequently occurred while in the hospital.

But we still need to determine if the implicated blood products contained West Nile virus. And we're going to be using some nucleic acid amplification testing techniques for both the pigtail context as well as the recovered products. We're also going to be working with American Red Cross to see if these donors have recently sero-converted and now have antibody IgM to West Nile virus, and we're going to be working with the hospital transfusion service directors and physicians to identify the recipients of the co-components to see if they've been recently infected.

So I didn't use the word "summary" because we still have so much work to do. But it is likely that this organ transplantation resulted in not three, but four West Nile virus illnesses out of the four recipients that received organs. Although mosquito bites are still the principal means of acquiring infection in endemic and epidemic zones in the United States, you know, we really have to think about whether transfusion played role in it. So we're going to be investigating these as a possible source of virus for the organ donor.

But I think at this point I think it's still best to say that to date there haws been no case of West Nile infection that has been shown to be due to transfusion, but this investigation has to go on.

I was asked to announce before I walk out the door--and this is the second thing that I was asked to announce--that we're involved in a second investigation, an investigation of a Mississippi resident who received 18 blood products--18 units of blood products as part of an obstetrical surgical procedure in late July. Approximately four weeks after receiving those transfusions, she developed West Nile encephalitis, confirmed case, no doubt about it. She was identified as part of some of our epi surveys, epidemiological surveys that we are doing down in Mississippi.

We are working with the blood collection agency doing the exact same things that we are doing for the case that I just described to you.

This person, by the way, recovered and is doing well.

The big difference here is that this person lives in an area that--well, I don't want to use the word has "epidemic" West Nile virus, but there are lots of human infections from the area where she lives. We know that those people did not receive transfusions. We know that they got it from mosquitoes. So that implies that she may have gotten hers as well, and you can see where we're going to have some difficulty in terms of making this determination ultimately.

Should I--I'll wait for questions.

DR. BRECHER: Well, why don't we hear from the FDA. Then maybe the two of you together can answer questions.

DR. GOODMAN: Okay. Good afternoon. I'm Jesse Goodman, Deputy Director at CBER, for those of you I have not met.

First of all, I'd like to thank Tony and CDC for preparing a presentation of the cases and of the epidemiology of West Nile on short notice and coming down from Fort Collins to do that. We really appreciate that and it's very helpful.

I'm also very appreciative, although we're all very busy and anxious right now, of the opportunity to be here because I think that this is an area where communication is absolutely critical. And I would say it's critical on two fronts. One front is communication about the reality of what's going on so we can deal with it, and the other is communication that is oriented towards assuring that the perceptions and the reality come together in some kind of reasonable way.

Okay. When I thought about this last night, I said, you know, really we're almost in a pre- and post-state. And the background is that before 9/4/02, the date on which the collaborative investigation and the CDC laboratory testing was able to show fairly convincingly that the donors indeed had--the donor had West Nile and three, at that time, of the recipients did, until that time this was a concern that had been out there for some time, that there was a biological plausibility for transfusion transmission to occur for this virus. And it's not unique among viruses, certainly. And Tony presented this extensively, but the reason is there is a transient viremia in patients, and most patients are asymptomatic.

However, this risk has been viewed, at least in the past, as likely to be very low. There's been no non-chronic carrier state. There have been no cases reported in prior years in this country or in endemic countries where many, many people have been infected.

Something that helped prompt our recent alert was the CDC risk modeling which was performed and published in Transfusion this month or last month, based on an assumption of a six-day viremia and 100 percent transmission suggested that during an epidemic circumstance in an epidemic area--so it's important to remember that--that something like 1 to 2 in 10,000 could become exposed through the blood. Again, this is--and Lyle Peterson and Dr. Biggerstaff, the co-authors of this, were very careful in the article, if you read it, of mentioning the many limitations of the available data and the assumptions. Risk could be considerably lower. Risk in certain circumstances might be higher.

It's important to mention that our current understanding with respect to plasma derivatives is that the procedures used to produce them inactivate related flaviviruses, and this risk is perceived as low. But our Division of Hematology is looking more carefully at that data now and we'll be sure whether we have a need for any additional data.

So based on this pre-9/4 level of concern, FDA, working with CDC and NIH closely, issued an alert on 8/17 that the blood community is very familiar with that really just raised this possibility and emphasized the importance in areas of endemic transmission of exclusion for prodromal symptoms, fever, et cetera. We recognized that this would not take out asymptomatic donors, but we felt we should do what we could and also increase awareness of the problem.

Okay. What about after yesterday when these transplant patients were identified as likely infected by their organs? Well, certainly there is a very high suspicion that transmission has occurred by organ transplantation, as just presented. And as mentioned, possible sources for the donor's infection that we are aware of are two: a mosquito bite or multiple transfusions.

We obviously have a heightened level of attention and concern, and while at this time, as Tony said, there are no proven cases of transmission by blood transfusion, there's certainly an increased suspicion and concern about this. Even though the results of this investigation may or may not be definitive, we have to, again, understand that this is a distinct and real possibility; and if it didn't occur now, it could occur in the future.

Certainly organ transplantations, with their degree of immunosuppression and with the potential dose of virus which could be received in the organs, would be, you know, a particularly susceptible population if this occurs.

What is the current public health response? And I'm not going to have anything really new to say here. I'm just providing a framework for where we are and where we at FDA and our partners think it's reasonable to go.

There is an ongoing partnership with CDC, the States of Florida and Georgia, and, now because of the organ transplant issue, HRSA, and I should say that we have daily, if not a couple times a day, conference calls. And we'll do that so long as it's helpful and necessary.

There's continued investigation, as Tony mentioned, of the possible blood source. There has been a withdrawal of in-date products. And I should mention that our blood centers and the blood industry involved have been extremely cooperative.

We have tried very hard to give continued and increased quantity of information to and communication with the blood community, the health professionals, the media, and consumers. And the media have been very, very interested and, in general, I think particularly with the print media, have done a pretty good job grasping some of the subtleties of this. And we've worked very hard to try to do that. And I would say, again, CDC and FDA have both spent a lot of time on this.

Part of the purposes of this are stimulate reporting. If there is a problem, we want to know about it. We will investigate any other plausible reports, and you just heard about the Mississippi case where there was a much better history for natural exposure, but it was still of concern enough to prompt an investigation. And we want to do balanced risk communication, stressing risks and benefits of transfusion and transplantation. As Tony said and as Jim Hughes said, the risk of West Nile virus right now is far higher from mosquito bites than from transfusions or organ transplants. And as we say, the risk from transfusions is unproven right now, but certainly unknown in terms of level.

And I think we need to emphasize that there is an ongoing aggressive investigation, an attempt to share new knowledge with the public, and take action as indicated.

What else more substantive? Those are the things we do. They're our job. We try to do them well. I think we need to define more knowledge here. It would be desirable to rapidly deploy a clinical research agenda, and I think the different agencies in the Public Health Service and the blood industry have indicated a willingness to cooperate on this. You know, it takes some time to set up and do studies, so we have to keep expectations realistic. But these are just some examples of things we can think about, not things that I'm saying are in progress right now.

But there could be retrospective studies, for instance, based on reports or investigations of any possible donor or recipient infections. And I think as this level of alert has increased in the population, we're going to have to expect a lot of reports of things that probably are not related to transfusion or organ transplants and may not even be West Nile virus infection. That's the nature of when we raise a lot of public health concerns; you get a lot of things reported that raise concerns but on careful or maybe sometimes first look are proved to be something else.

But for those that are plausible donor infections, we should, as we're doing, follow up recipients for clinical infection and their serology. And in cases where recipients have West Nile virus, potentially coincidentally, when we want to investigate obviously we would look at donor samples. So this is sort of rote.

In addition, I mention there the use of potentially banked specimens and resources. This is something we would like to explore whether there are useful specimens out there that could help address some questions, whether in these areas of high transmission or in other prospective studies.

Possible prospective studies that--just thinking very quickly in the last couple days, it would be really nice to know the incidence of viremia in donors in an endemic U.S. setting.

You can see that that's not an easy study to do if the CDC risk modeling suggests that it could be 1 to 2 in 10,000. However, some anecdotal, more anecdotal experience in Israel suggests that in certain pockets it could be higher.

Certainly if we looked at a thousand donors and didn't find it, that would be somewhat reassuring; and if we did, that's information that would be helpful to have. So this would be important.

One could look at seroprevalence in frequently transfused individuals. Again, there'd be a lot of confounding and we'd have to be very careful what the controls were and the geographic issues. But that might be a worthwhile study, and these are things that many people in this room are much more experienced than I am with respect to blood-borne infections but have used successfully in really defining the epidemiology of other blood-borne infections.

I think although most of the data suggests that viremia is short-lived, since if we do find this to be a problem with blood we're basing a lot of policy on that, it would be good to get harder data about that. And CDC is doing some studies which I think will be helpful in that. And, of course, any other ideas that people have would be great.

Okay. What if a problem is identified and intervention is needed? And I don't think we have information at least with respect to transfusion now to necessarily indicate that. But I think it's important that we think about and discuss and get input about some of these possibilities ahead of time.

Well, there could be additional donor screening or deferrals. But the possible approaches that at least we've thought of so far aren't too satisfied. We got asked questions about just deferring anybody with a mosquito bite. Obviously this would not be a high-sensitivity or specificity medical intervention, and it would probably precipitate a supply crisis.

One could look at very high areas of transmission if we could define them. If we could define areas where transmission is so intense that the risk is much higher than in other areas and the likelihood of blood being in asymptomatic donors is higher. That is an approach that one could take.

Given that, as was discussed, the epidemiology of this disease is a moving target, these little mini-epidemics turn off and on like a faucet, this may not be a very practical thing to do within a blood system. And also the broad range, as I said, could be a problem, and certainly you couldn't say from all--what is it?--31 states? Is that right? That was the last I heard--that you'd defer blood or something. It's not going to work.

Recently--I mean, many people in this room are interested in pathogen inactivation. There was a recent FDA workshop on this. There's a lot of promising technology coming down the pike. There are also some legitimate issues about use of that technology. But one could think about pathogen inactivation, particularly if you found that it was only certain kinds of blood recipients who were most susceptible to this infection and you could identify the seasons and places where this was going to occur.

In other words, if you could construct a risk/benefit paradigm and identify patients who might benefit from pathogen-inactivated blood, that would be one strategy. Again, please be very careful. Just because I'm from FDA, I'm not saying we're doing this. I'm not saying we're proposing it. To me this is right now a scientific discussion to get input and to provoke thought. It's just too early in this for us, any of us, to pretend that we have enough knowledge to know the most efficient approach, if any, to this and what, if anything, we even need to do. But I think these are interesting things for people to think about, and part of the reason to present them is to stimulate thought.

We've heard a lot about the possibility of testing of donor blood. Again, if needed, there's a lot to think about. We've gotten questions: Why don't you just immediately test all donor blood? And I think people don't always get the technological difficulties, the resource issues, and the fact that those resources may have to be shifted from one area of blood safety to another or from one area of health care to another.

Those are important things to consider in policymaking, but from a medical or public health point of view, let's face it, all our scientific assumptions here could be a little off. It could turn out that West Nile transmissions from blood does not end up being rare and ends up being a real problem. If it turned out that way, we do need to look at donor screening.

So, again, if it was needed, the questions would come: Do we need to do this for all blood? Do we possibly target this to areas of transmission or, again, to blood that is going to be used in patients who we would be concerned would get sick from the infection?

There are some parallels with the use of CMV-negative blood for bone marrow transplant patients, for example. So if we--now, you know, this takes much more data. I mean, I would never recommend that unless we knew that it was safe for some patients and we could identify a risk group. But these are important issues that need resolution.

Consistent with Dr. Martin's comments, we would think that antibody testing is unlikely to identify most early asymptomatic donors with viremia. So, therefore, direct detection is most likely to be of potential value, and, of course, when you talk direct detection and current technologies, we mostly have nucleic acid amplification or antigen detection.

Reportedly, sensitive and specific PCR diagnostic assays have been developed in both research and clinical lab settings out there. But these have been used primarily in diagnostic settings and not in labs handling very large numbers of samples. And the technologies vary in terms of their potential ease of transfer to a screening setting. So there are some real challenges here in terms of making sure that technology is good and then transferring it to the kind of setting that, again, the people in the blood industry here are much more familiar with some of the special demands of in terms of the testing. Also, the use and validation for donor screening, obviously the demands on a test for doing medical diagnosis of sick patients and the sensitivity and specificity acceptable for that are different than for blood screening. So this would need to be looked at or validated.

But I think we can't be too pessimistic. Some people have said to me, well, this would be years if we needed it. And that might be too pessimistic because we do--there are some facilitating factors. The diagnostic industry, the blood banking industry, and the FDA, for instance, have accomplished a reasonable amount with nucleic acid testing, and, in addition, once there is evidence of a test that can be useful and correctly produced in an acceptable manner, the potential for use under IND is there.

And, again, if we identified areas or populations at risk, it would be possible to target that kind of use first in that direction rather than have it be general.

So what I want to say is that I think there are some real barriers. I got one call that said somebody announced that there would be a test next week and all the blood in the United States would be screened. And I said, well, that's great. You know, not that it needs to be screened, but that would be great if we had that test. And, you know, I said you should look into it. And, you know, if you want to tell us more about it and talk to us more about it, that's fine.

So I think we need to recognize that the blood industry, the diagnostics industry have been through some of this before, that the challenges are substantial. But I think all of us, if faced with a pressing public health need, would try to meet those challenges.

I will say that after some communication with Dr. Slater, the Assistant Secretary, and at her request, FDA is planning to organize sometime in the near future a workshop to consider diagnostic issues, to have some sharing of what technologies are out there, and to try to stimulate discussion and preparedness in case that's needed.

Okay. So, finishing off, again, this isn't going to say much more than Tony said, but the investigation continues. There is a high level of alert and concern. It's important to recognize it's a potentially evolving situation. You just heard another piece of lab data. You could hear another piece tomorrow. If a blood donor turns out to be positive--we don't know that they will, but if they did, obviously that will ratchet up the interest and attention. So we all need to be ready for what our messages and responses are.

But, clearly, there is a need for better defining the actual risk and potential strategies to mitigate it. And, again, I reiterate, at this point on the blood transfusion end, we have no proven risk. We have a high level of concern, and that's a different thing.

We need to continue with close interagency collaboration and industry cooperation. We need to continue the communication. I've kind of said all this before. We need to encourage and facilitate technology development and transfer. And, again, I'd like to reiterate, irregardless of the results of the current investigation, it would be great--I would have been happiest if the organ donor hadn't been a source, and it would be great if we find that blood is not a source. But I still think we need to be prepared for this possibility.

Finally, we really, all of us, will seek continued discussion of this issue and input in various formats from various communities as additional information becomes available. So I thank you all very much.

DR. BELCHER: Thank you. We are running behind schedule, and maybe we have time for one or maybe two questions from the members.

Rick?

DR. DAVEY: First, thank you both for that very useful update.

A quick question, Tony, for you. You mentioned that the organ donor, you had an early sample and a late sample. Obvious question. Have those samples been correlated with the timing of transfusion?

DR. MARTIN: Actually, that's what was I doing last night is I was putting all of those blood forms in order of the time, and we still have to find the time that the early one was obtained. The late one was at least 12 hours after the last transfusion.

DR. BRECHER: Harvey?

DR. KLEIN: Could I ask you, the NAT assay that you described, two or three logs, those are copy numbers and not infectious units; is that correct?

DR. MARTIN: I am pretty sure they're infectious units.

DR. KLEIN: Those are infectious units?

DR. MARTIN: Yes. When we talk about significant viremia in humans, horses, cats, birds, we're usually talking about 10 to the 4th infectious units.

DR. KLEIN: And during that early viremic period where you get a low-level viremia, it will spread from nodes to liver and spleen, is there then a period where you can't detect virus with blips or can you always detect that low level until you then get the increased level of spread to the central nervous system?

DR. MARTIN: All of that primary viremia work is all done in animals, in which it was used with a needle to go intradermally and then sacrifice the animals to see just exactly where everything was.

So, in humans, I was extrapolating, and it's unknown.

DR. BRECHER: Celso, last comment.

DR. BIANCO: Tony, is there a correlation between early diagnosis of the encephalitis or meningoencephalitis and the outcome? Is it something that we should be telling physicians to be aware today, that this is a potential risk? Would that benefit the patient?

DR. MARTIN: Just like people have been looking for years, and years, and years a way to talk about dengue and yellow fever causing transfusion, people have been looking for a role for ribovirin for years, and years, and years with regards to flaviviruses.

Although it looks good in cell culture, it has not been shown to be beneficial, mostly because it hasn't been put in at trial. There are some anecdotal stories out of Israel.

I think there were some anecdotal stories out of New York City in 1999, but recently the FDA has been working with a gentleman from the New York Hospital of Queens to do a randomized open-label trial of alpha interferon. Again, you all know this from hepatitis C, and that's why people are looking at ribovirin and alpha interferon. So this person does have a trial going, although it is a little slow now, I think he has enrolled about four people to date, unfortunately. But we had him on our conference yesterday, so maybe we'll get better enrollment.

DR. BIANCO: Send him south.

DR. BRECHER: John, last comment or question?

MR. SKINNER: Quick question. Plaa derivatives, on of the slides indicated that this was similar viruses were inactivated. Can we tell the community that's dependent upon plaa derivatives, with absolute certainty, that West Nile isn't activated and, if not, are there plans underway to validate that assumption?

DR. GOODMAN: I'll defer to Jay on that. That's a good question.

DR. EPSTEIN: We've reviewed all of the virus inactivation studies for all of the licensed plaa derivatives, and what I can tell you is that for all of the products, one of two things is true; either that product had validation with removal or inactivation of one or more flaviviruses or it uses a process which, in someone else's hands, was extensively validated with one or more flaviviruses.

What I cannot tell you is that any of those studies directly were done with West Nile Virus because they were not, but I think it comes down to a similar question. We were not able to do those studies with hepatitis C because there's no culture or system for hepatitis C, and yet the systems that validated viral safety for hepatitis C by the use of so-called marker viruses, have proven sufficient to ensure the safety against hepatitis C, and there's been no tranission since we've put in validated viral inactivation methods.

So the question really comes down to how similar or different do we think the question is for West Nile to be validated by marker viruses versus a hepatitis C, which was validated through marker viruses such as BVDV, Sindbis, and others.

So I think the bottom line is that we're highly confident that all of the licensed derivatives are manufactured with procedures that would remove or inactivate flaviviruses, including West Nile. So we're as confident as we could be, short of repeating all of the experiments with West Nile Virus, and I personally don't think that that's actually necessary since the approach of using marker viruses has proved inadequate for other similar agents.

MR. SKINNER: Thanks for that. I'm sure you can appreciate the hypersensitivity in the communities about this information, and I think we need to figure out a cogent way to tranit that explanation and information in rapid fashion.

DR. EPSTEIN: Sure. And I think a corollary, though, on the theory of belt plus suspenders, is that it would be reasonable to do some serological surveillance in the hemophilia community, especially comparing samples recently since 1999 and pre-'99 to find out whether there have been any infections out of proportion to background in the population.

Now those studies would take time to do, but I think that, whereas, it's important to do those studies, we shouldn't be approaching them with a mind-set of panic because I think that we have, in fact, available a very high level of assurance that the products are not at significant risk.

DR. EPSTEIN: That was clearly my goal in asking the question, is to avoid the panic and be able to respond to all of the inquiries we're receiving.

DR. BRECHER: Thank you. That was very helpful.

We now enter the public comment portion of the meeting. If someone has a comment or a question, please come to the microphone.

Please come up to the microphone, identify yourself, and state your question or comment.

MS. SCHULMAN: Good afternoon. I'm Roslyne Schulman, a senior associate director for Policy Development at the American Hospital Association. On behalf of the AHA's nearly 5,000 hospitals and health care systems, we appreciate the opportunity to provide comments to you.

The topics I'll address include the blood supply, blood safety and costs and reimbursement issues. I'd like to submit written comments for the record.

The nation's hospitals are facing worsening shortages of blood, shortages that have serious, even life-threatening implications for the patients we serve. These shortages are forcing hospitals in some communities to limit blood-intensive services, such as cardiac surgery and organ transplantation.

Last year, the AHA conducted a survey of hospitals to learn more about blood shortages and their impact on patients, and here are some of the things we learned:

A majority of America's hospitals, 57 percent, indicated that they experienced a shortage in 2001. The impact was greater in urban areas, which was 77 percent, than in rural areas, 42 percent. Blood shortages cause serious interruptions in hospital operations and patient care, such as cancelled or rescheduled surgeries and ambulance diversions.

One in three hospitals reported that shortages have grown more severe over time. Over the course of one year, 14 percent of hospitals experienced more than 10 blood shortages and 11 percent had shortages that lasted for more than a month. Hospitals are taking various actions to relieve shortages, such as holding blood drives, seeking out other sources of blood and encouraging conservation.

There are several ways to mitigate these shortages: For example, blood conservation efforts hold much promise. We encourage the Advisory Committee to work with the blood community and hospital representatives to develop and disseminate model practices in this area.

However, the greatest promise for inadequate and sustained blood supply lies in increasing blood donations and maintaining those donors over time, and that's why we urge the Federal Government to forge a partnership with the private sectors to step up efforts to increase blood donation.

We strongly encourage increased collaboration between stakeholder organizations such as the AHA, the blood community and the Secretary of HHS. This collaboration should develop and fund a major national blood donor campaign to ensure that a safe and adequate volunteer donor base is available for all who need it. We're looking forward to being involved in such an effort.

The AHA is committed to the continued safety of America's blood supply because it is a critical factor in the quality of care that hospitals provide. New technologies have helped us to improve blood safety, but have also led to higher blood prices. Higher blood costs are a result of FDA-mandated screening tests and donor deferral requirements and other processing and handling methodologies that are intended to bolster the safety of the blood supply.

But blood prices have also risen due to other changes in blood processing whose patient safety benefits are less clear. For example, the American Red Cross, which supplies half of the blood use by hospitals, changed its policies so that hospitals are now able to purchase only leuko-reduced red blood cells. Since then other blood service providers have also adopted the practice of universal leukoreduction. While it's clear that targeted leukoreduction benefits certain categories of patients, there's no scientific consensus to suggest that this additional processing benefits all patients, and it is expensive, increasing the price of blood between $30 to $40.

The price of blood is expected to run even higher in the near future, as FDA formally mandates new screening tests. For instance, nucleic acid testing will double in cost as it moves from research to a licensed test. The price will increase even more if FDA mandates that individual testing replace the current pooled testing, viral inactivation, a technique under development that's expected to double or triple the price of blood.

This is occurring in an environment in which hospitals are already in dire financial straits, with one in three hospitals losing money. The nation's hospitals strongly support a safe and adequate blood supply. However, in an era of tightening budgets, we need to ensure that any new screening test or processing technique meets a high standard of scientific evidence demonstrating substantially improved patient outcomes or other improvements in patient safety.

We urge the Advisory Committee to carefully consider scientific and clinical evidence before recommending the widespread use of these tests.

For years, the steep inflation in blood prices has not been appropriately accounted for in the Medicare payments to hospitals. However, an important first step has taken place. Starting in October, the Medicare Hospital Payment System adds a separate component to the market basket index, which is an inflation index to account for changes in blood prices. This new blood index, which is tracked by the Bureau of Labor Statistics, will more accurately reflect the price that hospitals pay for blood and blood products and services.

Still, the index is far from perfect, and more work needs to be done to improve it so that it better captures fluctuation in prices for the full range of blood products used by the nation's hospitals. Moreover, as we heard this morning, due to change in methodology in outpatient reimbursement, hospitals will see a sizeable reduction in payments for blood-related outpatient services.

We look forward to working with the Advisory Committee to address these issues. We appreciate this opportunity to present our concerns, and I'd be pleased to answer any questions.

DR. BRECHER: Thank you.

Any questions or comments?

[No response.]

DR. BRECHER: Next comment, please.

MR. BROWNSTEIN: My name is Alan Brownstein, and I'm the president and CEO of the American Liver Foundation.

I am here today to thank this committee for addressing the issue of West Nile Virus and beginning to sharpen the focus on what this may mean for the American public. It is our concern that we find answers rapidly as to how the public may be at risk, as this may relate to a transfusion-tranitted disease, as well as one that is tranitted through organ donation to the organ recipients.

We want to know how the organ recipients are at risk, and we also want to know how those who may be most vulnerable, those who are immunosuppressed, and that, too, relates to organ recipients and those with HIV, how they may be at risk with respect to transfusion-tranitted, organ-tranitted West Nile Virus.

It is urgent that these risks be assessed as soon as possible. However, there's also the concern that was expressed here today that we not cause undue alarm, and of course we should try to avoid causing undue alarm, but there must be a profound sense of urgency. It is so important that this profound sense of urgency exist so that we could acquire these answers as soon as possible.

However, as the previous speaker, as the speaker from the FDA pointed out, definitive scientific answers may not be readily available. Indeed, that may be true. So, therefore, I think it is very important that even if we do not have definitive scientific answers that are readily available, it is important to look at the potential impact, the potential impact on morbidity and mortality and take precautionary measures to safeguard the public, even if we do not have definitive scientific answers.

I recall the time back in the early 1980s when we did not have definitive scientific answers that we saw the oking gun with respect to HIV, and certain precautionary measures could be taken. So I urge that this committee, this committee which, as all of you know, you were born out of the IOM report, the IOM report on HIV in the blood supply, and this committee was set up as the sentinel body to safeguard the public.

So all I say is you're doing a great job, and what I hear from the FDA, and from the CDC and HRSA, it seems that everyone is ready, but it's important that we be mobilized, and expend the resources and take the steps that are necessary to get the scientific answers, and at the same time, concurrently, take the necessary precautionary measures to safeguard the public.

Thank you very much.

DR. BRECHER: Thank you.

Any responses from committee members?

[No response.]

DR. BRECHER: Next public comment?

MS. REARDON: Good afternoon. My name is Susan Reardon, and I work with Ortho-Clinical Diagnostics, a Johnson & Johnson company. Most of you know this company. We've been in the business for over 60 years, and it's a very important heritage business for us.

I've delivered a statement to your chairs earlier, and I'm not going to read through that statement because you have actually granted much of the relief requested in that statement, and for that I want to thank you on behalf of not just myself, but the innovators of technology that helped to create a safe blood supply.

I've asked for permission to insert the full statement in the record, and received permission, and I thank you for that as well.

I would like to simply draw your attention, however, to several of the additional recommendations that you did not address. I applaud the efforts of Dr. Brecher, the chairman, and the rest of you to start to assess the effectiveness of this organization by reviewing the status of the implementation of the recommendations that you've made at previous meetings, and I have identified several previous recommendations of this committee that I believe have a great deal of bearing on the future effectiveness of the reimbursement issues that so concern this industry.

One of those recommendations has to do with adding a nonvoting representative to this group from CMS, and I've been assured that as this committee is rechartered, that in fact a representative from CMS will be added to this committee. I would recommend that such a representative be an appropriate one, a high-ranking one, who can bring back the important messages delivered at this committee to CMS.

And then the second recommendation is, again, to implement the prior recommendation of this committee, which was to develop guidelines, for CMS to develop comprehensive guidelines on reimbursement in the outpatient system so that hospitals are fully aware of and can more accurately code for and bill blood and blood products.

I thank you, again, for your recommendation this morning, your resolution, and I urge you to continue to follow up on these recommendations and resolutions in the future, perhaps adding that as a regular item of business for future meetings.

Thank you very much.

[The statement of Ms. Reardon follows:] ********** INSERT **********

DR. BRECHER: Thank you, Susan. And thank you for not reading it all into the record.

Next comment, please.

MR. VOGEL: Mr. Chairman, committee members, my name is Rich Vogel, and I'm the immediate past president of the Hemophilia Federation of America and present chair of the Blood Safety Committee at the Hemophilia Association of New Jersey.

More importantly, as a severe hemophiliac who contracted HIV and hepatitis C through the use of blood products, the decisions and recommendations of this committee directly affect my quality of life. I remember 40 years ago spending hours and hours in hospital emergency rooms. We've come a long way since then, but are now threatened to go back to those days and even worse.

I would urge this committee to act on the recommendations of this morning and follow through with its implementation. I don't want to be turned away from emergency rooms for lack of access or, worse yet, be admitted to the hospital for a simple, minor bleed, so I can receive the quality of care we have fought so long for.

I would also urge this committee not to backtrack on prior recommendations. When the question was put to this committee during the discussions on leuko-reduced blood, if you would rather you or your loved ones receive leuko-reduced or unleuko-reduced blood, only one person responded to preferring unleuko-reduced blood.

As technology and new science moves forward, we should embrace it as opposed to pushing it aside because of cost. If NAT testing makes a safer product, let's use it and find a way to have it reimbursed adequately. Let's not blame the blood shortages on mandated safety regulations.

We saw during 9/11 an increase in donations. The donors are out there. Let's figure out a way to get them back and not trade safety for supply.

Thank you.

DR. BRECHER: Thank you.

Next public comment?

UNIDENTIFIED PARTICIPANT: Since I seem to be the last one, I'll keep it brief because I know everybody is tired.

First of all, I want to echo some of the comments that Rich made, especially in the area of the HOPPS situation that we're in right now with reimbursement for blood products. It's been a long two years since the summer of 2000, when the first horrible Medicaid AWP reductions came out, and it's gone downhill since then. We certainly don't want this new thing on the horizon to make it even worse.

I applaud the committee for your actions this morning. I hope that you will follow through, through the Secretary's office, and see that this one, along with some of the others, are actually followed through on.

At the same time, I would like to say that I am delighted to take back to our constituents the fact that at this meeting today West Nile Virus was addressed. It has not taken nearly as long to bring this to the attention of the committee and to the powers that be as it took us to wade through HIV, and hep C, and CJD, and we are absolutely delighted that this discussion happened. We appreciate the opportunity to interact with FDA and CDC on what is going forth with this.

Along those lines, I would like to put forth a recommendation that I requested yesterday afternoon on the phone conference, in that, in addition to looking at whether or not West Nile can be tranitted, either through blood transfusions or organ donations, that we think in terms similarly to what Mark Skinner said earlier about the immunosuppressed community and say are there any other things that we can take back to our community, other than the traditional spraying, use of DEET, staying away from standing water, and staying inside at the peak hours of infection or biting of the mosquitoes.

Coming from Louisiana, I'm very, very interested in this, but I'm really specifically interested for our community.

Thank you, again, for addressing this very urgent issue, and let's stay on top of it. Thank you for your attention.

DR. BRECHER: Thank you. One last comment.

MR. CAVENAUGH: I'm Dave Cavenaugh of the Government Relations staff for the Committee of 10,000, and I merely wanted to urge that the main topic of the day, which is supply monitoring, be thought of as an access issue, just as the CMS HOPPS issue is, and that we not forget the supply of plaa because there really wasn't any discussion of that today.

There's an assumption that the PPTA monthly data takes care of that, but that data is not exhaustive, it's not really a discussion of collections, and doesn't give us any flavor for how the 9/11 changed the numbers that were coming forward and how the demographics of the population coming forward are now and have been.

If we're looking at collections, let's look at all blood and blood product collections.

Thanks very much.

DR. BRECHER: Thank you.

Committee members, take a deep breath, and let's launch into additional recommendations, besides the two that we had from this morning.

The floor is open to suggestions.

MS. LIPTON: Could I ask, in the public awareness, I mean, with all of these, we actually have some recommendations that are already outstanding, and I hate to repeat ourselves, and I feel that somewhat we're going to be repeating ourselves. You know, public awareness, I think we've asked for a role, a very visible role, of the HHS Secretary at very high levels.

We saw the HRSA program today. I'm grateful that blood donation is in there, but, frankly, we're somewhat of an afterthought in that, and it's too bad that we can't have more visibility in that program because it is, I think, funded at a good level that we would like to see.

I guess with respect to, what's number two? Inventory. Is that the number two issue?

The number two issue, I think we've made some recommendations. I see, you know, that we now have a number of different programs. It's hard to comment on how they all fit together. Although I liked Jay's explanation, it would be nice to see that in writing. I think the real issue is what Harvey said there, that is, ongoing funding so that these aren't "one of" studies or pilot projects that don't have any continuation because the one message that came through today is that you need to collect the same data over and over again to have some predictive value.

I can't even remember what the third one was.

DR. KUHN: The national campaign.

MS. LIPTON: Oh, the national campaign. I don't know. I'm frustrated because it seems that we've had these recommendations.

DR. BELCHER: Actually, we started by stating several, what they were.

Jay actually has some wording for some proposed recommendations, so why don't you read those, Jay.

DR. EPSTEIN: It's a little bit lengthy, but I'll read them, and then I think we'll probably put them up on a screen. They're, of course, straw men for further discussion.

On the point of public awareness, the suggestion is that the Department of Health and Human Services should promote increased public awareness of the ongoing need for routine blood donation by healthy persons via, one, periodic public service announcements by top officials and paid advertising campaigns; two, funding of demonstration projects to optimize use of educational and other behavior-influencing approaches; and, three, supporting specific initiatives to encourage routine donation by young persons and minorities as part of general messages on healthy lifestyles and community support. So that's the proposal on awareness.

With regard to monitoring, the proposal is as follows: That the Department of Health and Human Services should maintain and/or increase funded support for blood supply monitoring to address, one, long-term trends in blood collection and use; two, data on daily nationally distributed blood inventories; three, indicators of blood shortages and excesses; four, predictive models to determine or identify critical inventory levels or trigger points for coordinated national donation campaigns; and, five, coordination of governmental and nongovernmental initiatives.

Lastly, with regard to reserves. Department of Health and Human Services should support initiatives of the interorganizational task force and other groups to improve management of blood inventories, including, one, the potential role of liquid and frozen reserves, first, to moderate fluctuations in supply and, second, to improve disaster response preparedness; and then, secondly, again, improve management of blood inventories including integration of supply forecasting into strategies directed to correct imbalances in supply and need.

So it's a lot of text, but I think when it's put up on the screen, we'll be able to get our arms around it.

DR. GILCHER: That's fine.

DR. BELCHER: Yes, that sounded pretty good to me too. I think I've said this before. Jay, you've had some experience running these sorts of things.

DR. GILCHER: I guess just the one thing that I'd is that we already have the model the organ donor campaign which relates very much to us, and it fits right with what Jay is saying. Maybe we even make reference to this in the memo.

MS. LIPTON: Excuse me, Jay. Did you mention plaa in there--you were going so fast--in monitoring?

DR. EPSTEIN: I didn't because we really didn't discuss it today. I mean, that's something we can talk about.

MS. LIPTON: We have discussed it at past meetings.

DR. EPSTEIN: In the past, right, and there have been past recommendations, but we've had whole meetings on plaa supply and derivative monitoring.

DR. BRECHER: How do other committee members feel?

Rick?

DR. DAVEY: I also think Jay captured the relevant issues on all three items, and I'm fully supportive of what will be written.

If we could capture, perhaps, in the public awareness piece, a little bit of what Ron said, and others have said, that perhaps--I don't know how to word this--that we might want to shift our emphasis to a little bit of the fact that blood donation is now becoming essentially a civic duty, and I don't particularly like the word "obligation" either, but I think if we get the word "civic duty" in this context, I think it might give a bit more emphasis to this particular point because we are in a state of, I think, crisis, both in supply and in our national crises also.

I also am very much supportive of the coordinating comments that Jay brought in, in number two. I think coordination of all of the five or six or eight processes that were described this morning is essential.

In my particular organization, we're expending more and more time responding to these various requests, and it would be great if we could find some coordination in all of those things. That's my comments.

DR. BELCHER: Harvey?

DR. KLEIN: While Jay's wording is going up, I have to say that I was very surprised at what I heard today. Dr. Gee pointed out that when you hear the same message from different sources that you sort of have to sit up and listen to it.

What I heard at today's meeting is the Red Cross told us that they're at critical levels, 50,000 units. ABC's stoplight showed a disturbing number of yellows and reds on their slide. The HHS database showed an increased number of reports of shortages. We didn't go into what kinds of reports those were, but they were clearly increasing. The NBDRC showed a 12.8-percent rate of delayed surgery last year, 12.8 percent of hospitals reporting.

The New York Blood Center is issuing increased amounts of Rh-positive blood to Rh-negative patients. We heard that the military needs an additional 10,000 units of blood potentially for emergency purposes.

So I think we really do need to kind of preface this with a sense of some urgency. Here all of these different sources are giving us the same message. I also think we do need to consider whether or not we have eliminated too many people from the current donor base, and revisit some of the decisions that have been made earlier.

DR. BRECHER: I agree with that, Harvey. I think the one other thing I heard a couple times today was that seven days' supply in the blood centers seems to be a goal for many of the centers. Maybe that's something that we should put on paper and strive for.

DR. KLEIN: I think the other statistic that I wrote down, which again astonished me, was that the American Hospital Association's survey showed that 57 percent of hospitals experienced shortages in this past year and 77 percent of those in urban areas. I think that should be eye-opening to all of us.

MR. ROSS: I'd like to embrace what Colonel Fitzpatrick mentioned today, and that is the strategies of intervention.

I was struck by Dr. Katz' presentation, whereby their blood center has a participation rate of 14 percent. That really is a tremendous achievement versus the overall average in the country of 5 percent is something else.

I would suggest that HHS could play a significant role in regards to Federal employees. There are 2.7 million Federal employees in the United States. I can tell you, in the greater Washington, D.C., area, only 3 percent donate blood, and I think HHS could play a leadership role in urging all Federal employees to increase their participation rate, and maybe we can help get to a rate of 10 percent even, maybe not 14, but maybe 10 percent.

DR. BELCHER: Do you want to word a resolution to that effect, that the HHS should take a leadership role in donations?

MR. ROSS: I'd be happy to if I could have some wordithing help. I would recommend that the Health and Human Services play an integral role in--

DR. BIANCO: Play a leading role, actually.

MR. ROSS: Yes. Thank you, Celso.

DR. BIANCO: It has to involve all of the other agencies too.

MR. ROSS: On behalf of Federal employees, HHS play a leading role in increasing participation of Federal employees in blood donation programs throughout the United States.

DR. BELCHER: What percent of the population are eligible to donate? Do we have that number?

DR. BIANCO: Jeanne has it.

DR. LINDEN: Well, I wrote a paper in 1988 that basically estimated approximately 60 percent, and I've tried to update it, and good data just are not available. It's probably even fewer now with our increased deferrals.

DR. BELCHER: So possibly 50 percent, possibly, in that ballpark.

CAPTAIN MURTRY: Allan, I was writing down what you said; that you recommend that DHHS play a leading role in increasing participation of Federal employees in donating blood. That doesn't sound very good, but it's a start.

MR. ROSS: That is a start. There are others--Jay is certainly much better at drafting these than I am, and there are probably others around the table that are better at that than I, but the intent is there.

DR. BRECHER: It'll be easier I think once we get it up on the screen that we can play with it.

[Pause.]

DR. BRECHER: How about West Nile Virus, do we, as a committee, need to say anything other than we support ongoing research into West Nile and other pathogens?

MS. LIPTON: Yes, I think we can say we support the current efforts of the FDA and the CDC in monitoring this issue.

DR. DAVEY: I would also include something like we share the concern of the agencies and others so that we not just support, but share concern.

DR. BIANCO: And probably we should, also, I think that one of the people at the public hearing noted that, I think it was Jan, the speed with which the information came about and came to us. I think that we should not only support, but that we are very happy with the way things are being handled.

DR. BRECHER: So I guess we can something like the committee is pleased with the current state of the investigation or something to that effect.

DR. KUHN: And probably that recommendation or resolution should also have continued periodic reporting back to this committee or informing this committee of the findings so that we can keep communities informed so that there is no panic, but, you know, education is information.

DR. BELCHER: Yes. Actually, one of the topics where I hope to take the committee next meeting is to go over all of the perceived risks, transfusion-tranitted disease risks to the blood supply.

Jay?

DR. EPSTEIN: I think, as a preface to the set of recommendations on awareness, and monitoring systems and so forth, we need to capture the point that Dr. Klein made, which is that data from multiple sources appear to indicate a serious problem with blood shortages in the United States at the present time, indicating an urgent need to improve systems to monitor and increase the blood supply.

DR. KUHN: I was just looking back on some of our recommendations, and to incorporate plaa or plaa derivatives would be in order, since it was in the August 24, 2001, recommendations that we made. So if we could insert that someplace in number two, that would probably be very acceptable.

DR. BRECHER: I think that's reasonable. Maybe we can take five minutes to try to get everything up on the screen. Maybe we can even double-team the two computers so we can do it a little faster.

DR. LINDEN: I have a question for Jay on Item 2(b), assuming that that's what you actually wrote. I'm not clear what that means, nationally distributed blood inventories. Are you talking about blood in the hospitals and not blood centers? What does "distributed" mean?

DR. EPSTEIN: I just mean that on a daily basis there should be some ability to know where the blood is, and I think that that logically needs to include both collection center and hospital inventories, otherwise we're not looking at the whole picture.

DR. LINDEN: So that's in addition to blood center inventories and distributed.

DR. EPSTEIN: I think where you're misunderstanding my intent is on the word "distributed." I'm not talking about blood distribution. I'm talking about the geographical distribution of where the blood is. Because I think if all we get are aggregated figures, like, you know, what's today's U.S. blood inventory, that's inadequate. You want to know where it's located.

So that's what I meant by distributed. I apologize. I know that's not clear in the text, but it had nothing to do with whether it's a distributed or nondistributed unit. What I mean is where is it geographically.

DR. LINDEN: So like regionalized.

DR. EPSTEIN: Regional, you know, major metropolitan area, where it lives in the distribution chain; is it at the blood center, is it in the hospital? But what I really was getting at is where is the blood.

DR. LINDEN: Okay.

[Pause.]

MS. LIPTON: I think one of the things that we're missing on the, you know, if we are going to add plaa to number two, is what the specific monitoring issues are for plaa because they're going to be a little bit different than what we're talking about in blood.

Our previous recommendation had just said to monitor supply and demand of plaa derivatives. I just don't know how applicable the A, B, and C are to plaa derivatives.

DR. EPSTEIN: I don't see where you are.

MS. LIPTON: Under two.

DR. EPSTEIN: What if we just said blood and plaa derivative inventories? Of course, I'm not sure that that's meaningful daily. I think it doesn't--

MS. LIPTON: That's why I'm saying I think there might be some different issues related to plaa monitoring that might be slightly different than what we have articulated up there as being important for blood.

DR. EPSTEIN: As I said before, we didn't talk about derivative monitoring today, and I'm a little bit uncomfortable knowing exactly what I'd want to tell the Department.

DR. BELCHER: Well, I think what we can do is probably provide the Assistant Secretary a listing of all of the prior recommendations, and say this is where the committee has been, this is what's been recommended, just as a reminder, and then the plaa monitoring was in the prior recommendations.

Does that sound like a reasonable compromise?

MR. SKINNER: I think the piece that's new in this recommendation that's not in our previous recommendation is looking for predictive models, something that's forecasting, which I don't know that our previous recommendation indicated that's we need for the derivatives, and I think that's our goal is we want the data so that we can predict future shortages for those products. I think the other pieces are addressed, and maybe we could just add that piece to this recommendation, that we need predictive models for derivatives as well.

DR. BELCHER: I think that's reasonable. I think we can do that.

DR. BRECHER: Are we all in agreement about number 1? Is the wording adequate, public awareness? Anybody have any other suggestions? Jay? You can't, Stephanie. It was your wording.

DR. EPSTEIN: Not quite, because I had wanted "advertising campaigns" to come after "top officials." "Periodic PSAs by top officials, and paid advertising campaigns." It's not clear to me that the officials should do the advertising campaign.

DR. DAVEY: Could we also say "Periodic PSAs and blood donation"--"blood donations by top officials, and paid advertising campaigns"?

DR. EPSTEIN: Dr. Ross' point. Sure.

Can you make those changes?

STAFF: I'm sorry?

DR. EPSTEIN: We'd like 1(a) to say "periodic PSAs," and I guess we're talking about--what?-- public blood donations. "Visible blood donations by top officials." Comma, "and paid advertising campaigns." And then strike the rest of it.

[Pause.]

DR. BRECHER: Okay. So everyone agree with number 1? Can we take a vote on number 1? All in favor? All opposed? Okay. Number 1 is passed.

Number 2, changes. There should be a space between "should" and "maintain." Also a space between "term" and "trends." Now we get back to the question with predictive models, do we want to say something about both blood components and plaa derivatives?

DR. EPSTEIN: Mark?

DR. BRECHER: Yes?

DR. EPSTEIN: I think it's not quite right because even if you have trigger point monitoring, it's not clear that it translates into national donation campaigns. I mean, it could translate into, you know, increased fractionation capacity, changing patterns of domestic versus export use. I mean, it's just not clear that the plaa issue is focused on campaigns. We already collect two times more plaa than we need for domestic need.

MR. SKINNER: No, I think you raise good points. I think if we can just have a commitment from the Chair that we can fully discuss this at a future meeting and pick up the pieces that are missing here, because I think there are items to discuss, but I don't think it's ready--we're ready to do it fully today.

DR. BRECHER: I think that's reasonable, to be given the time.

DR. DAVEY: Jay, on (e), did you mean coordination of governmental and intergovernmental monitoring initiatives? Should we be a little more clear on what initiatives are being discussed in (e)? Should it be governmental blood monitoring initiatives?

DR. EPSTEIN: Well, the heading is "Support for blood supply monitoring to address..." I mean, it's redundant. But, also, I think it was meant to say "governmental and nongovernmental initiatives." That's what I actually said.

DR. BRECHER: Wasn't one of our goals to try to facilitate the transfer of excess supply from one region to regions that didn't have much of a supply? I don't--reading that, I don't really get the feeling that that's stated.

DR. EPSTEIN: There was an effort to capture that point elsewhere. It's not in this section, but we could add it in this section. But is that monitoring? This is just monitoring--

DR. BRECHER: Right, I see, to improve management. That's number 3.

DR. EPSTEIN: Also, I think (d) can be condensed a little bit. "Predictive models to identify trigger points." Just take out "determine." Just make it "to identify trigger points."

Take out "critical inventory levels." Just make it "models to identify trigger points." And then just make "campaign" into the plural, "campaigns."

DR. BRECHER: Everyone happy with the wording of number 2?

[No response.]

DR. BRECHER: All in favor of number 2? All opposed? Let's move to number 3.

DR. DAVEY: 3(a) should be reworded a bit.

COLONEL FITZPATRICK: (a) should read "potential role of reserves, liquid or frozen." "Liquid and/or."

DR. EPSTEIN: Perhaps (a) would also read better if it said "defining the role" instead of "the potential role." So "Improve management of blood inventories, including a defined role for"--

COLONEL FITZPATRICK: "Defining the role"--

DR. EPSTEIN: "Determining the role" or "defining the role."

MS. LIPTON: I think what we're looking at is determining. I think we've had different models up here, and what we want to do is explore each of them and figure out how they work or don't work.

DR. EPSTEIN: Okay. So "defining the role of liquid and/or frozen reserves." I'm sorry. You want "determining" or "defining"?

MS. LIPTON: You can use "defining." I was going to say "determining," but it's the role--"roles" maybe possibly with an s, because you might have both.

DR. EPSTEIN: Yes, you have--the word "reserves" is there twice. It should come out where it first appears and strike the word "the" in the beginning.

MS. LIPTON: I'm sorry, I meant "s" in a parenthetical where you have "roles." So put "role(s)."

DR. EPSTEIN: Strike "reserves" where you are right now.

Now you have to add back the word "liquid" before the word "and."

Now you have to add a space after the word "of."

DR. BRECHER: Down in (b), it should be "a need."

MS. LIPTON: Can I ask also one question? This is directed to Mike. Yours really wasn't focused on disaster. Yours is also focused on potential military need. Is that something we need to include in this? Because Mike's whole proposal was to prepare for military response to need.

COLONEL FITZPATRICK: Well, in 2 you could put "improve"--I think "disaster" would cover it.

MS. LIPTON: As long as you're happy with it.

COLONEL FITZPATRICK: There's manmade disasters. There's natural disasters.

MS. LIPTON: Okay. Disasters of our own making?

DR. EPSTEIN: In 3(a) I would take out the semi-colon after "reserves."

Also in (a), it should say "role(s)," not "roles(s)."

DR. BRECHER: It's just been pointed out that we've just lost our quorum, so what I would propose we do is we continue to wordith these statements. Then we will distribute it by e-mail for a vote.

Any more wordithing on number 3?

[No response.]

DR. BRECHER: Okay. Let's put this on the screen.

COLONEL FITZPATRICK: Karen, were you wanting something specifically about HRSA somewhere, or--

MS. LIPTON: Where's number--oh, that was--the HRSA actually was covered up in the public awareness, and I think it's fine because if they choose to do that through HRSA--you know, my only comment was it was a shame we weren't in there more prominently.

DR. EPSTEIN: Mark, if I could come back to your point about moving blood from excess regions to shortage regions.

DR. BRECHER: Right.

DR. EPSTEIN: Point 3(b) was intended to capture that concept, so if it doesn't, we should add it there.

DR. BRECHER: Well, that talks about forecasting, Jay. It doesn't talk about what's actually happening at this moment.

DR. EPSTEIN: Right. Okay. The idea, though, was that the way you correct imbalances is you move blood. But it could be made more explicit, certainly.

DR. BRECHER: Well, I think, you know, we could say--

DR. EPSTEIN: Why don't we add (c)?

MS. LIPTON: Could you just add "existing and future supply"--"imbalances in supply and need"?

DR. BRECHER: Or you could say "integration of current supply and forecasting into integration strategies."

MS. LIPTON: That works.

DR. EPSTEIN: I think we should just say in (c), "strategies to facilitate movement of blood from areas of surplus to areas of shortage."

"Strategies to facilitate movement of blood from areas of surplus to areas of shortage."

DR. BRECHER: Yes, I think that addresses it.

[Pause.]

DR. EPSTEIN: Mark, could I come back up to the earlier proposal that we capture Dr. Klein's thought with an opening remark?

DR. BRECHER: Sorry, which thought?

DR. EPSTEIN: This is above all these recommendations--oh, okay. Then I'll just wait.

[Pause.]

DR. BRECHER: We've been diligently working on another computer over here.

MS. LIPTON: Does your other one include West Nile virus, or could we--oh, good. I was going to say--oh, could we just say whatever you said?

DR. BRECHER: Harvey is the--

DR. KLEIN: I've started to do something on that. I think we probably should share the concern, express--commend the work that's been done, and urge continued aggressive investigation and public information.

[Pause.]

DR. KLEIN: Well, I thought we would put something like--and we can add numbers in which I captured are in the record, if one wishes, but, "Data from several sources"--and we can list those if we wish--"presented at this meeting indicate that the nation's blood inventory is currently at critical levels and that blood shortages during the past year have resulted in postponed surgery and suboptimal transfusion therapy. Furthermore, to assure a ready reserve to address potential military needs, additional blood resources will be necessary."

DR. BRECHER: Is it just potential military needs or potential military needs and disasters?

DR. EPSTEIN: Well, potential disasters and military needs, because military needs are ongoing in terms of preparedness.

Is there a point that we need to make about gaps in the current monitoring? In other words, why are we talking about increased efforts at monitoring if we think, you know, the data already tell us what we know? So I think there's another thought that needs to be added.

Maybe it comes in the first sentence, "Although the current monitoring tools have significant limitations"--

DR. KLEIN: I think that's probably a wonderful introductory phrase: "Although the current monitoring tools"--did you say--

DR. EPSTEIN: "Significant limitations."

DR. KLEIN: "...limitations, data from several sources..."

DR. EPSTEIN: No. It's "Although the current monitoring tools have significant limitations..."

Right, comma and then all d. We don't need a comma after the closed parens.

DR. BRECHER: Harvey, would you propose putting this at the top, above the--

DR. KLEIN: I would propose putting this or something like this as an introductory.

DR. EPSTEIN: I think it should then say "therefore" and appear just, "Advisory Committee Blood Safety Availability recommends," and then continue with that set of recommendations that we drafted. And then make this current paragraph follow that entire set, because it's a new subject

DR. KLEIN: That was exactly what I had in mind. That's why I separated this, and I thought the Committee should share the--as a separate thought. So why don't we put in, for the first paragraph, "Therefore, the Committee recommends the following," or so you can put that at the end--yes, at the end of that first paragraph, very end, the end of the first paragraph after "necessary." "Therefore, the Committee recommends"--that would be a colon. "that:" and now the recommendations will follow that.

DR. EPSTEIN: While you're there, you might want to change the semicolon to a colon.

Yes. That would be Number 4.

DR. BRECHER: Well, actually, we're going to have to renumber at the end because we had Number 1 and 2 from this morning, but we'll renumber later.

MS. LIPTON: Harvey, you had the rest of that language, didn't you?

DR. KLEIN: No, I actually just started working on that. Something like--where are we now with it? Get back to that start. Okay. "We commend HHS for the rapid response to this potential risk, and recommend continued aggressive investigation." All the way at the bottom, all the way down.

Okay. "We commend HHS for the rapid response to this potential public health risk, and recommend continued aggressive investigation." Now we want public information or something.

MS. KUHN: Can we use the words "monitoring and surveillance?" Is that--because that would encompass--that would encompass what the CDC is doing as well as FDA.

DR. KLEIN: Just add "and public communication."

DR. EPSTEIN: "And public communication."

MS. LIPTON: An investigation? So you wanted to say "aggressive monitoring, surveillance and investigation, and?"

CAPT. MURTRY: Monitoring goes after surveillance and investigation and [off microphone].

MS. KUHN: That's simple, short.

MS. LIPTON: Right.

DR. EPSTEIN: I think the sense of this second sentence needs to be that we recommend aggressive efforts to clarify the actual risk and the feasibility of effective interventions. I think focusing on monitoring is wrong here because that's only a little piece of the larger scientific effort that has lots of dimensions. So I think public communication is also very important, but I think it can be its own stand alone statement. So I would be inclined to say "And recommend continued aggressive efforts to determine the actual risk and the feasibility for effective intervention."

MS. LIPTON: Didn't go anywhere.

DR. EPSTEIN: Are we agreed to that change?

DR. KLEIN: Yes.

DR. EPSTEIN: So after the word "aggressive" change it to "aggressive efforts to determine"--

MS. LIPTON: Hadn't you used "clarify the risk" before?

DR. EPSTEIN: Okay, "to clarify the actual risk", or the should be plural, right, "the actual risks and the feasibility for effective intervention." Change "of" to "for." No, no, "the feasibility for effective intervention," and then period and take out the rest.

And we want a sentence about, "Additionally, DHHS is encouraged to continue to disseminate timely public information."

DR. KLEIN: That's perfect.

MS. LIPTON: Could you write these earlier, Jay, so we're not sitting around?

DR. KLEIN: I certainly couldn't have said that better myself.

DR. EPSTEIN: It's actually possible, you know.

DR. BRECHER: That looks great, Jay. We will distribute this by e-mail to the members and take a vote by e-mail.

Any other comments?

DR. EPSTEIN: I would just change, in the second sentence, item 4, make it "DHHS" for consistency.

DR. BRECHER: Oh, yes, DHHS. We also will renumber it.

DR. EPSTEIN: Right. And I think 4 shouldn't be 4. I think these are two subject headers.

DR. BRECHER: Right. Mac, you will review this with me before we send it out.

CAPT. MURTRY: Right, I will.

MS. LIPTON: We don't even have a quorum to adjourn, do we

DR. BRECHER: No, but we're going to anyway. As it is, I'm probably going to miss my plane.

CAPT. MURTRY. Thank you.

[Whereupon, at 5:52 p.m., the meeting was adjourned.]