Blood Safety Transcripts

ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY

Sixteenth Meeting

WHAT LESSONS CAN BE LEARNED FROM THE EVENTS
OF SEPTEMBER 11, 2001, THAT WOULD STRENGTHEN THE SAFETY
AND AVAILABILITY OF THE UNITED STATES BLOOD SUPPLY?

Volume I

8:03 a.m.

Thursday, January 31, 2002

Hyatt Regency Capitol Hill Hotel
400 New Jersey Avenue, N.W.
Washington, D.C. 20001

Voting Members

Mark Brecher, M.D., Chairman

Larry Allen

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.

Gargi Pahuja

John Penner, M.D.

Mark Skinner, J.D.

Jerry Winkelstein, M.D.

Government Representatives [Non-voting]

Mary Chamberland, M.D.

Jay Epstein, M.D.

Colonel G. Michael Fitzpatrick

Harvey Klein, M.D.

David Snyder, D.D.S.

Consultants to the Committee [Non-voting]

Christopher Healey, J.D.

Allan S. Ross

AGENDA and ITEM

Call to Order, Introduction of Members,
Conflict of Interest

Lessons from Previous Disasters:

Paul Schmidt, M.D.
University of South Florida

Ronald Gilcher, M.D.
Oklahoma Blood Institute

The Experience and Actions of the New York
Blood Community on and after September 11
Robert Jones, M.D.
New York Blood Center

The Experience and Actions of the
Washington, D.C., Blood Community on and
after September 11
Gary Ouellette
Chesapeake and Potomac Red Cross

The Experience of the Food and Drug
Administration on and After September 11
Alan Williams, Ph.D.
Food and Drug Administration

The Federal Government Role in Assuring
Blood Safety and Availability During a Disaster
Stephen Nightingale, M.D.
Department of Health and Human Services

The State Role in Assuring Blood Safety
and Availability During a Disaster
Jeanne Linden, M.D.
New York State Department of Health

A Military Perspective on Assuring Blood
Safety and Availability During a Disaster
COL G. Michael Fitzpatrick
Armed Forces Blood Program

An International Perspective on Assuring
Blood Safety and Availability During a Disaster
Jean Marc Gabasto, Ph.D.
Pan American Health Organization

Blood Community Perspective on Assuring
Blood Safety and Availability During a Disaster

Karen Lipton, AABB

Donald Doddridge, MA, MT [ASCP]
American Association of Blood Banks

Lisa Marie Brody
America's Blood Centers

Jerry Squires, M.D.
American Red Cross

Edward Snyder, M.D.
Yale University

Medical Industry Perspective on Assuring
Blood Safety and Availability During a Disaster

Elizabeth Bewley
Advanced

Andrew Heaton, M.D.
Chiron Corporation

Karen Long
Roche

Dr. Mark Popovsky
Haemonetics Corporation

Susan Reardon
Ortho Clinical Diagnostics

Susan Sanborn
Abbott Laboratories

Patrick Schmidt
FFF Enterprises

James Weston
Biopure

Monitoring the Capacity of the Blood
Supply to Meet Demand

Judith Chapman
National Blood Service, United Kingdom

Stephen Nightingale, M.D.
Department of Health and Human Services

Public Comment

Adjourn

DR. NIGHTINGALE: It is 8:03 a.m. Good morning. My name is Dr. Stephen Nightingale. I am the executive secretary of the Advisory Committee on Blood Safety and Availability, and this is the sixteenth meeting of the committee. I would like to begin by calling the roll.

We have a new chairman, and it is a pleasure to welcome him. This is Dr. Mark Brecher. When I call your name, would you say present, for the record, and also practice using your microphone.

DR. BRECHER: Thank you, Steve, and I am present.

DR. NIGHTINGALE: Mr. Larry Allen, I believe, cannot be here today.

We have another new member of the committee who is about to sit down, and that is Dr. Celso Bianco. Dr. Bianco, welcome to the committee.

Mr. Rajen Dalal.

MR. DALAL: Present.

DR. NIGHTINGALE: Dr. Richard Davey?

DR. DAVEY: Here.

DR. NIGHTINGALE: Dr. Ronald Gilcher?

DR. GILCHER: Here.

DR. NIGHTINGALE: Dr. Edward Gomperts?

DR. GOMPERTS: Here.

DR. NIGHTINGALE: Dr. Paul Haas?

DR. HAAS: Here.

DR. NIGHTINGALE: Dr. Keith Hoots?

DR. HOOTS: Here.

DR. NIGHTINGALE: Dr. Kuhn, I believe, will not be able to make the meeting today. He may be able to make the meeting tomorrow.

We have another new committee member, Dr. Jeanne Linden.

DR. LINDEN: Present.

DR. NIGHTINGALE: Dr. Linden, welcome to the committee.

DR. LINDEN: Thank you.

DR. NIGHTINGALE: Ms. Karen Lipton?

DR. LIPTON: Present.

DR. NIGHTINGALE: Dr. Lola Lopes?

DR. LOPES: Present.

DR. NIGHTINGALE: Ms. Gargi Pahuja plans to attend the committee. I anticipate her presence shortly.

Dr. Penner?

DR. PENNER: Here.

DR. NIGHTINGALE: Thank you, Dr. Penner.

We have another new member of the committee who is just walking in. He is recognizable by the marks of recent surgery, Mr. Mark Skinner. Mr. Skinner, we are delighted that you have joined us on the committee.

Mr. John Walsh?

MR. WALSH: Here.

DR. NIGHTINGALE: And, finally, Dr. Jerry Winkelstein is not able to be here today.

The government representatives to the meeting are Dr. Mary Chamberland.

DR. CHAMBERLAND: Present.

DR. NIGHTINGALE: Dr. Jay Epstein?

DR. EPSTEIN: Here.

DR. NIGHTINGALE: Colonel Michael Fitzpatrick?

COL FITZPATRICK: Present.

DR. NIGHTINGALE: Dr. Harvey Klein?

DR. KLEIN: Here.

DR. NIGHTINGALE: And Dr. David Snyder, who I anticipate will be here shortly.

In addition, we have invited two people to become consultants to the committee. This is a practice that we have had in the past. It does not infer special government employee status on the individuals. It acknowledges the fact that we, on a very regular basis, seek their advice and are appreciative of it.

They are Mr. Christopher Healey.

MR. HEALEY: Here.

DR. NIGHTINGALE: And Mr. Allan Ross.

MR. ROSS: Here.

DR. NIGHTINGALE: The second, and last, order of business that I have is a reading of the conflict of interest statement. Our previous chairman referred to this as a ritual. If it is a ritual, it is nevertheless a ritual which involves reading from Title 18 of the United States Code, and that is the criminal statute. So I encourage your active attention to the following:

The following announcement is made as a part of the public record to preclude even the appearance of a conflict of interest at this meeting. General applicability has been approved for all committee members. This means that unless a particular matter is brought before this committee that deals with a specific product or firm, it has been determined that all interests reported by the committee members present no potential conflict of interest when evaluated against the agenda.

In particular, as specified in Title 18 of the U.S. Code, 208(b)(2), a special government employee, which all committee members are, may participate in a matter of general applicability. For example, advising the government about the topic of today's discussions, even if they are presently employed or have the prospect of being employed by an entity, including themselves, if they are self-employed, that might be affected by a decision of the committee provided, and this is in italics, "that the matter will not have a special or distinct effect on the employee or the employer, other than as a part of a class."

The example given in 5 CFR 2640.203, which implements Title 18 of the U.S. Code 208(b)(2) is as follows: A chemist employed by a major pharmaceutical company has been appointed to serve on an advisory committee established to develop recommendations for new standards for AIDS vaccine trials involving human subjects. Even though the chemist's employer is in the process of developing an experimental AIDS vaccine, and therefore will be affected by the new standards, the chemist may participate in formulating the advisory committee's recommendations. The chemist's employer will be affected by the new standards only as part of the class of all pharmaceutical companies and other research entities that are attempting to develop an AIDS vaccine.

In the event the discussions involve a specific product or a specific firm for which a member has a financial interest, that member should include him- or herself from the discussion, and that exclusion will be noted for the public record.

With respect to all other meeting participants, we ask, in the interest of fairness, that they disclose any current or previous financial arrangements with any specific product or specific firm upon which they wish to comment.

I would conclude, as follows: The purpose of having this meeting is to ask all present if they have any suggestions how we can better prepare ourselves for the future. If that is not a matter of general applicability, I do not know what one is.

I think the guiding principle here--oh, I guess there are two. One is common sense, and the other is common sense. If I feel that anybody is even close to the border, I will let you know, but the point here is to bring people in and not to exclude either people or ideas from the discussion.

With that, it is a pleasure to turn over the meeting to our new chairman, Dr. Brecher.

DR. BRECHER: Thanks, Steve.

We're running a little ahead of schedule already, and I hope to continue to be ahead of schedule. We are going to be on time.

The topic for discussion in this session is: What lessons can be learned from the events of September 11th that would strengthen the safety and availability of the United States blood supply?

We'll begin by having two speakers talk about lessons from previous disasters, and the first one is Dr. Paul Schmidt, from the University of South Florida.

DR. SCHMIDT: Thank you. I'm honored to be invited to address the committee.

I'm here because 25 years ago there was a retirement of an employee at the blood center in Tampa who had spent 30 years doing what she called blood banking. So that carries us right back to the beginnings.

She was interviewed by the local newspaper and was asked for her most striking memory. Her most striking memory was the day the school bus turned over and all of those wonderful people donated blood and all of the employees worked very hard. I checked the files. Of course, no blood was used for the school bus passengers.

But I began to follow up disasters that made national news in the media, and the story was always the same. How many people had died, how many people donated blood and how hard the people in the Blood Bank worked, how much blood they collected. The stories rarely told how many people were critically injured and never how many were in need of a transfusion or how many transfusions were actually given.

I began to gather that information from friends in the field, some of whom I see here today, and the story was always the same. The call for blood usually came from some well-meaning media personality, spread widely, often no blood was needed. If some blood was transfused, it was, of course, from the shelf collected before the disaster, but the reports are always the same over and over again in those 25 years--how many people were killed, how many wonderful people gave blood after the disaster, and how hard the staff worked.

I have some data on the significant disasters. The actual facts coming out of that are medical facilities usually will have a 3-day supply of blood on hand. If that stock is depleted in three hours, it will not be needed for elective surgery the next day because the surgeons will stay home. Meanwhile, blood already tested and ready to use can be brought in from neighboring communities less than three hours away, followed by more, and more, and more.

If survivors are in the range of the overwhelming numbers that were expected or feared on September the 11th, then the capability of medical personnel to administer blood will also be overwhelmed, and donating blood immediately for 500 or 5,000 or 50,000 casualties will not result in more emergency care.

Those facts were not appreciated on September the 11th in the call for an instant national blood donor response. Even if there were the 50,000 victims, instead of the less than 500 who were admitted to hospitals, more blood could not have been used than was already immediately available. Despite that, a half-million units of blood were collected nationwide.

Disasters that we may hear about today I have arbitrarily put in these categories, as you can see: minimal, delayed, floods, tornadoes. What happens after floods is the people who get their arm cut off by a chain saw in cutting down the tree in front of their house after the disaster, and I am talking about the acute needs for transfusion, and that's what I've limited my talk to today.

Mine disasters again are delayed. Immediate are manmade, and the major ones are structure collapse, explosion, aircraft, shooting, bombing, some fire--although that may not be immediate--and in this country we don't have any history of large blood use in rail or railroad.

Now I have the data on--

[Pause to take care of slides.]

DR. SCHMIDT: These are the data that I've been able to find and get over the years. On the form disasters, 20 years in the United States, in which more than 100 units of bloods were needed, used immediately. They happened in different sized communities, different times of the day, different reasons, different kinds of injuries, and in all four, the community, which was centralized as far as blood, was self-sufficient, and no blood from outside of that community was used for disaster victims.

There are numbers are here, and Dr. Linden and I have already talked, it's very difficult to get these numbers. There are inflated numbers and deflated numbers, depending whose ox you're goring or sharpening, but, anyway, this applies to the entire presentation.

In Kansas City, the hotel collapse in the Hyatt atrium threatened more than 1,000 people who were there. The cooperative media worked with the community blood center to issue the correct message that there was adequate blood available and that appointments would be made for future generations.

Injured is actually the people hospitalized, except for Sioux City. Those were the people on the plane who were injured, but about 80 of them walked away from the crash. It was an emergency crash landing of a large plane that was scheduled to land someplace else. Sioux City has about 80,000 people, and they really mobilized a care situation for those victims. They already had in their two hospitals and small blood center, 713 units of blood, and over the next day they collected 602, and they did use 119 units of blood.

Kansas City, we have up above, had a much larger, because it's a larger area, it had 2,500 on hand. It did collect blood. It transfused 126.

Oklahoma City I think we're going to hear more about today. The bombing of the federal building took place on a weekday morning, and there were a lot of bloody casualties because of flying glass. There was a national donor response, but in Oklahoma City, after nine hours of collecting blood, the Oklahoma Blood Institute informed the public that supplies were adequate. These are data that Dr. Gilcher, I'm sure, will speak to and Ms. Belcher presented shortly after the disaster.

The last one of these is the Denver Columbine shooting. A small number killed, but a fairly high usage of blood, 105 units, and all of the blood reports in here are red cells or early on whole blood. I haven't said anything about platelets or plasma in these studies because they're there. It's not the reason that people donate blood, which is the topic of our general conversation. There was one patient who got 50 units of blood at Columbine, and that's what pushed up the total.

The interesting thing about Columbine is they make a point, after the disaster, they thanked the people who gave the blood before the disaster and made it possible to transfuse those people. In case I forget to mention it later, I've seen a marked absence of that information in anything since then, with the exception of Harvey Klein's paper. Who went out and thanked the people who gave the blood that was used? Very little of that at least gets into the major press.

I'm going to move now to how do we learn from these disasters or what do we learn into September 2001 and give you the next slide to say the American Red Cross learned very well from all of these tragedies, and they gave the appropriate response. I think it was the last appropriate response given on that day. It says, very clearly, "We're ready to send over 50,000 units of blood to New York and Washington. The Red Cross is not at this time calling for emergency blood donations." That's the press release that was appropriately issued, because of what they've learned in the past, on the morning of September 11th.

That proper response was not understood, I guess, at the executive level of the federal government. The U.S. Department of HHS ordered the immediate collection of blood for Pentagon victims at its nearby NIH research facility, and the national call for donors went out. The FDA authorized the collection of blood by volunteers, the interstate shipment of unlicensed blood and the transfusion of incompletely tested blood.

The next day the White House staff was asked to donate blood. When an attempt was made to halt the national overflow of blood and of waiting blood donors, the Red Cross did continue its appeals.

The New York and Washington areas get their blood from different sources, and you will hear of their donor activities later today. Meanwhile, blood was being collected as well at hospitals, which provide a significant percentage of blood in the New York area, at makeshift centers next to the White House, and in that week, America's blood centers collected 167,000 units of blood more than it had collected in the prior equal period.

The Red Cross figures, we have to look at the whole month because they continued their appeals, and in that month they collected 287,000 more than at the time before.

Blood that they were unable to test, unusable blood all over the country was never counted. That stuff that was collected in hospitals, it didn't get there. So almost a half-million units of blood may have been collected in the name of the disaster victims.

The information on actual blood transfusion was again reported. It was not gathered or released by the local hospital organizations, but for the two cities, my calculations are it comes to about 258 units transfused, compared to the minimum of 475,000 registered units collected nationwide. You will hear more data from the other speakers, I am sure.

The question of how many were hospitalized in New York, the data you see there, the 139, from the January 11th issue of to MMWR, which, as it says, got data from the five hospitals closest to the World Trade Center and the burn hospital that took care of the burn patients.

In the Washington, D.C., area, of course, the Pentagon is in Virginia, and it involved people who were treated at military hospitals, as well as hospitals in Virginia and the District. So it's quite possible that the actual numbers transfused are not what you see there. If they go up to 500, I have a lot of doubt, and still, there was enough blood collected to take care of 1,000 such disasters.

How can we correlate this to what we learned from previous disasters? Well, there certainly were benefits. There was well-deserved recognition worldwide of the value of altruistic blood donation. Experience from San Francisco after their earthquake there showed that it's possible as many as 39 percent of first-time donors in San Francisco after the earthquake there came back within the next six months. We read that may not be happening in New York.

The costs of what we did that we didn't learn from previous disasters. The blood intake system was in disarray. Platelets ordinarily harvested from whole blood were lost to use. A processing backlog blocked the testing of the fresh platelets needed in the following days for patients with medical thrombocytopenia.

Past disasters were made near collection sites, and they permitted distribution of excess inventory to other areas. The Oklahoma Blood Institute was able to ship out nationally 6,848 units of its overage in 1995. That was not possible in the current disaster because the message had come from Washington for everyone everywhere to donate blood.

The Red Cross, which ordinarily outdates 3 percent on its shelves, outdated 17 percent or almost 50,000 of the 280,000 extra units collected, and that doesn't take into account that which outdates in the hospital shelves which, of course, had been packed. There was an unknown number of additional makeshift collections of blood that were never tested and never included in the statistics. I think, taking the known 475,000, it's very easy to see that it's really a half-million.

In 1995, the Oklahoma Blood Institute received immediate monetary donations from industry to help finance the blood collections that it made. Since last September, the federal government has granted more than a half-million dollars to four organizations for their expenses in unnecessary blood collection and processing, but the greatest cost may be the loss of trust by the public in the industry.

We're supposed to be learning how to do things better. I think we did a lot of things better after September 11th. I've picked on some of the things that I don't think we did better. But they show, again, that mass appeal is neither a safe nor an efficient way to collect blood, and how could it be done better?

Well, let me point out to you that before places that use more than 100 units of blood before September 11th in the past 25 years were cities in which there was a coordinated blood center or blood authority or blood something. Everybody knew where the blood for those communities came from. That really needs to be established by the local emergency management distribution to manage not only disaster blood availability and distribution, but also collection. And the hospitals and media must know where the blood voice is in a community because that's what needs to speak. And, hopefully, that blood voice will be a very intelligent one.

We had one in a large city in Florida, where they had a wonderful TV video about disaster, where something hit the stadium and all of these emergency vehicles are going out to the stadium, and the red lights are flashing, and the blood mobile is going out to the stadium. I don't know what the blood mobile was going to do out at the stadium, but, anyway, you have to think about what you're doing in leaving this image in people's minds.

So, when a disaster happens, everybody has to know who that blood authority is, and whether it's the local, regional or national level, depending on the scope of the disaster, they need to speak to the public in the first hours before there is an outpouring of misinformation from anybody else, with the resultant outpouring of unneeded donors.

Similarly, I think I noticed in your call of the roll Dr. Nightingale, I don't know how many hospital representatives we have here. This is where the blood is used. These are the people from whom I couldn't find out from the hospital associations how many people were really critically injured, certainly not how many were transfused or how much blood they had. They're not interested in that because blood always appears. So this is the missing area in this blood puzzle of data. It's the hospital end, the transfusion end. This is now supposed to be transfusion medicine and not blood banking, and we don't talk about transfusion when it comes to disasters.

The immediate message, as was attempted in Kansas City, Sioux City and Denver, is that your blood will not be used today, but you'll be needed for future donations to replace the current supply. And then there needs to be a reporting on what happened.

As I said before, I heard almost nothing since September 11th about the fact that the people who are the regular blood donors, who donated blood before the disaster, are the people who saved the problem, and nobody has spoken to this 2,000-fold disparity between collections and transfusions.

We need a public education campaign, and this might be the time to start it, an education campaign that has been attempted, in some ways, to promote regular blood donation without emotional appeals, and perhaps it can be figured out how to seize on this disaster to really make a functional presentation of those needs. Those needs need to be exploited by this Committee on Blood Availability.

Thank you very much.

[Applause.]

DR. BRECHER: Thank you, Dr. Schmidt. I think we have time for one or two questions, if someone has any questions for Dr. Schmidt.

DR. KLEIN: Paul, in all of your years, in thinking about this issue, can you conceive of any kind of scenario at all, either civilian or military, in which you would need this kind of a mass appeal, even one that was an order of magnitude lower than the one that we had?

DR. SCHMIDT: I think the answer to that is it's impossible to transfuse blood to 50,000 casualties or 5,000. We're kind of pushing it with 500, even if it is national. By the time you get those medical teams where they should be, they're doing triage. There are few people getting emergency transfusions. The ones who really would need it in an ordinary disaster are being sort of pushed aside. We learned something from the military.

And maybe it's useful, and maybe Glen will speak to it, I think the military has a number that it's developed of one or two units of blood needed per--maybe Glen will speak to it later--hospitalized or injured hospitalized persons. So that's a kind of rule of thumb. Obviously, the Red Cross knew it. They said we have 50,000 units of blood we can send immediately. Let's wait and find out what's going on before we get into this. I hope that person is still working for the Red Cross because that was a very intelligent response.

DR. BRECHER: Thank you, Dr. Schmidt.

We have one more introduction to make, and Dr. Nightingale will do that.

I'm going to do this because I think there is some legal thin ice here, and I want to make sure that I get it right. It is with great pleasure that I point out that we have been joined today by the person who I believe is appropriately titled the Designee Assistant Secretary for Health. Dr. Eve Slater has been confirmed by the Senate, but to my knowledge has not yet been sworn in, but that is going to happen imminently.

Dr. Slater will have many, many responsibilities. One of those, however, will be to be the Blood Safety Director. I join the entire audience in thanking Dr. Slater for joining us. She is very busy and will be even busier. Dr. Slater, will you identify yourself.

DR. SLATER: Thank you.

[Applause.]

DR. NIGHTINGALE: And did so without making us late. Thank you for that too.

DR. BRECHER: Thank you, Dr. Slater, Dr. Nightingale.

Our second speaker on Lessons from Previous Disasters is Dr. Ron Gilcher from the Oklahoma Blood Institute.

DR. GILCHER: Good morning, and thank you for the opportunity to talk with you this morning about disasters.

My talk will be slightly different from Dr. Schmidt's in terms of I'm going to bring this down to specifically the, so to speak, disasters in Oklahoma. I was going to kid with you a little bit and say that there were four disasters, not three; the fourth one being my attempt to get here from Oklahoma yesterday. If you have followed the news, we have an ice storm, and the governor has declared a state of emergency in Oklahoma.

Actually, we have had three major disasters, as far as we're concerned in Oklahoma, two of which you are aware of. Specifically, I think the whole country certainly knows of the April 19th, 1995, bombing of the Murrah Building, and then on May 3rd, 1999, we had the tornadoes, and there were actually multiple tornadoes, with the highest wind speeds recorded on the Planet Earth of 318 miles per hour, and I'm going to show you pictures of this.

But, interestingly, we had a wind sheer, which is kind of a tornado, that came through last year and destroyed one of our centers. This turned out to be absolutely invisible because of the way we have designed our system, and I'll talk briefly about these.

That's a picture of my home--

[Laughter.]

DR. GILCHER: No, that's actually the main--well, I spend most of my time there. That is the main center of the Oklahoma Blood Institute called the Sylvan N. Goldman Center. It is located about a half a mile from ground zero where the bombing occurred at the Murrah Building, and our building shook so violently from that blast that we had to bring structural engineers in to evaluate whether some cracks and so forth that occurred after the bombing were of significance.

Of course, this is the picture that nobody will ever forget. As Dr. Schmidt pointed out, and I have on subsequent slides, there were 168 people killed, and I was reminded by a minister when I gave a talk that there were 171 because he appropriately pointed out that three of the women who died were pregnant, and their babies died with them. So it's either 168 or 171 people died.

But there were approximately 400 people who were injured in that blast, and there was a significant amount of blood used. As Dr. Schmidt pointed out, in the first day, it was actually a little more than that, Dr. Schmidt, as we put the numbers together, and it was very hard to get those numbers, but it was about 170-some units in the first day, and in the first three days we figured there were about 300 units of blood used totally.

The next disaster was the tornadoes, and I'm going to show you again a slide that contrasts them, but this was very different because the bombing was in one spot. The tornadoes were everywhere. The destruction that you see here happens to be one of our, actually, one of our former employees, this was her home, and in fact all of the family survived, and one of the differences, interestingly, in these two disasters is the first one nobody knew was coming, as with the World Trade Center. On the other hand, the media was tracking the tornado so carefully that they clearly deserve the credit for preventing a lot of the deaths, and still there were 44 deaths with the tornado.

But this is a slide that shows you the extent of the tornado. This was a massive, mile-and-a-half-wide tornado that came through that looked like a giant rotary lawn mower, and it just totally leveled everything. There were thousands of homes destroyed. So we had widespread destruction, and yet very little loss of life when you look at the area of destruction--44 against 168 in the bombing. Reason--people knew the disaster was coming.

And then here is a little disaster that received essentially no notice, and that was the wind sheer that hit one of our centers, ripped the roof off, poured tons of water in and totally destroyed the center, completely invisible to the world and invisible to Oklahoma because of the way that we have designed our system with multiple subcenters and the other subcenters simply took over. As far as the hospitals were that were supplied by this particular blood center of the Oklahoma Blood Institute, there was no change in the service.

Now, as we looked at, and we had done this before, but we really learned a lot of lessons. What I want to do, at this point, is just take a few minutes and really talk about the lessons that we have learned. Very clearly, there are three things that are important. We used to talk about the plan, but now it's the process of planning that is so important because there is no one plan that fits every disaster. Basically, we are planning all of the time. We are always changing our disaster plan in some way. It is always in the state of evolution and occasionally it's a revolution when the disaster occurs.

But, also, the blood center infrastructure is absolutely critical; that is, how the center or centers are designed and set up. And then as I said many times before, as Dr. Schmidt said, the bottom line when the disaster occurs is blood on the shelf. And as you appropriately stated and said, Dr. Schmidt, it's the thank you to the people who donated in the days before, and we also clearly said that in Oklahoma because all of the blood used came from the people who had donated in the five to seven days before the bombing.

As I said, one plan does not fit all disasters, and certainly understanding the process of planning, you just don't stop with the plan. It's a continual process. That, clearly, has allowed us to be successful. Being able to change quickly, being very flexible, being sure that every single person in the organization has a function assigned to them in addition to their regular function because there are certain things that you don't have to do when the disaster occurs.

The question of who is in charge--in fact, I became one of the least-important people. I became, in a sense, a spokesperson because everybody knew what their function was, and they carried it out. I, in a sense, I felt as though I wasn't needed, but, in fact, I was, but I was not a critical person as far as handling the disaster because everybody knew what they had to do.

And then constant monitoring and rapid assessment, and I mean minute-to-minute assessment by appropriate staff so that we were doing the right thing at the right time.

Our blood center is not a single blood center. It's, in fact, seven blood centers, and that clearly has paid off. As I showed you, we have one blood center destroyed, but the other blood centers took over, so it's seven locations storing blood. We have our blood diversified over the state.

Transportation, absolutely critical in a system such as ours. When the bombing occurred, we moved blood quickly to the hospitals we knew would get blood. In the case of the tornado, we couldn't get the blood to the hospitals. The roads were cluttered with debris. We had to rely on not only our own vehicles, but clearly on the local police and the state police who clearly helped us. Helicopters could not fly at that time because of the tornadoes themselves being so active.

Having the right kind of equipment to go out and draw blood. And, again, as Dr. Schmidt pointed out, the big problem is really not the collection of blood. I mean, that becomes the problem because the first problem is how many victims are there and how much blood do they need, and the second problem is how do you handle the massive number of blood donors?

Communication systems become critical. When the tornado hit, a lot of our telephone lines went down, so wireless systems were very important, radios. We're a very large system. We cover from one side to the other over 350 miles. That is a 175-mile radius.

Power. Power is absolutely critical. We have generators and uninterrupted power source systems at virtually all of our centers now in order to back up the power needs, and that became a very big problem. Fuel--we have our own fuel tanks so that we can, in fact, always have power. This played a role last night when the power went out in Oklahoma City. We have a 4,000-gallon diesel tank. We can run our center for about three weeks without any outside power.

Staff availability, planned and unplanned. In our system, the employees who are not working, as soon as they heard there was a disaster, came in and immediately took on the functions that they had been preassigned.

Then having enough supplies, and I'm sure this happened to virtually all blood centers with the World Trade Center disaster. We ran out of reagents, we ran out of blood bags by the fourth or fifth day, in spite of the fact that we didn't need that blood, and we were trying to not turn away or turn off the donors, but we finally went to something that we had not tried before, which was very unique, and we are collecting that data. We collected samples from people who wanted to donate. Instead of asking them to come back, we actually collected samples because it was such a high percentage of first-time donors and then said we will call you, and that built a bond with those individuals, and so far we've been very successful in getting those individuals to come back.

Well, the bottom line is blood on the shelf, absolutely, clearly, when there is a disaster that uses blood. In our system, and as you said, Dr. Schmidt, most places only have a three-day supply. We've, in fact, designed our system to have a 14- to 17-day supply of blood. But in fact we've decided, as we look at bioterrorism issues, that this is not enough, and we are redesigning our system to have a 21- to 24-day supply, and I'm going to show you how we anticipate doing that.

Blood placement was strategic. It's in the hospitals and in our blood centers. For example, in our system we keep anywhere from 4,500 to 6,000 units either in our centers or in our hospitals at all times.

Well, handling the disaster itself. One of the most important issues is rapid assessment of the disaster, the number of people or victims involved, the likelihood of them being alive or dead, the types of injuries if they're alive. For example, as Dr. Schmidt said, we had a lot of penetrating injuries, and we had a few patients who used a lot of blood because of the penetrating injuries, glass that had penetrated not only tissues, but organs and, as a result, a lot of bleeding with the bombing.

On the other hand, with the tornado, we used a lot less blood. We had crush injuries, and there were broken bones, and there was blood used in the next 24 to 48 hours, more so than on the front end, but with the bombing, there clearly were people bleeding to death.

One of the problems that all of us face is anticipating the blood needs. When the disaster occurs, we don't know how many people are injured, and as a result, we don't know how much blood we will need. So what we did in Oklahoma was to essentially pick out the hospitals. We knew which hospitals would receive the victims, and we didn't know how many there were.

We actually delivered the blood to the hospitals, five hospitals in Oklahoma City, before the victims from the Murrah Building were brought in. So the hospitals were not only initially stocked, but we overstocked them, and that was with O-pos and O-neg red cells.

Well, then the next part of the disaster is how do you handle the donor response, and you addressed that Dr. Schmidt very well. I addressed it from the standpoint of the desire to help and the desire to heal, and it's that desire to heal that is the problem for us in the blood centers because if we turn the donors off or turn them away, then we will get a lot of negative feedback, and that is what none of us have learned to do well yet at this point, but there clearly is this desire the heal, and then attempting to anticipate the response, in terms of the numbers of donors.

We had no idea of the response we would get with the bombing of the Murrah Building. As Dr. Schmidt pointed out, we had over 7,000 donors in the first four or five days. What was amazing to us, Dr. Jones, is that we had more donors turn out the first day of the World Trade Center attack than we did the first day of the Murrah Building bombing. We had 3,646 donors that turned out, and this became, in a sense, kind of a disaster trying to handle that number of donors.

As Dr. Schmidt pointed out, one of the things that you cannot do is make components from that blood, so you lose all of the components because your staff is totally involved in the collection and handling of that blood in trying to meet the regulatory criteria for storage.

Then you have to handle everyone else. The media is extremely important. They can help you, they can hurt you, and we have very good relationships with our media, and they were a tremendous help.

And then you get gifts from everybody--food and drink, equipment, money. Everybody is wanting to help, and everybody is wanting to heal.

Now contrasting the bombing and the tornadoes. Factor one, location. The bombing was in one site, the same was with the World Trade Center. The tornadoes, they were everywhere. They covered a huge area. The bombing occurred during the day. That was very different when the tornadoes hit actually in early evening and at night.

The cause, terrorism. Terrorism scared the people in Oklahoma to death when the Murrah Building was bombed. On the other hand, a natural disaster has quite a different public reaction. As you see in Point 3, with the bombing, people were stunned, they were shocked, they were dazed. These are the same things that I am sure were seen with the World Trade Center. There was anger, and the fact that there was no warning. Obviously, that was different. We had warning. There was greater acceptance and understanding with the tornadoes.

The number of blood donors, 7,000 in three days. They were tolerant with the bombing, they waited, they wouldn't leave, they needed to heal, and obviously wanted to help. In the case of the tornado, about 3,000 donors in three days. They were intolerant. They didn't want to wait. They were angry at times with us because they had to wait--very different from the bombing.

At the Blood Institute, as far as staffing went, there was no problem. Our staff, as I said, who were not on duty came in without being called, knew what their functions were, and worked literally like dogs. They were overtaxed tremendously with the bombing. They were overtaxed with the tornadoes, but not as much.

The cost, very increased with the bombing. We lost all of the potential revenues from the components, and so I think people think that when you draw this blood that you're going to make a lot of money. It is not true. We had a major financial hit with the bombing and also with the tornado, but not quite as much.

As far as the victims, the 168 dead, penetrating wounds, comparing that to the tornado where there were 44 dead, we used probably a little greater than 300 units of blood in total for the bombing, about 175 probably in the first day. It was very hard to put these numbers together. This is over and above what we would normally use, and then with the tornado less than 100 red cells in three days, and most of that was really used in the second and third day for individuals with crush injuries, broken bones, who are undergoing surgical procedures.

With the loss of our blood center, just briefly, to talk about that, on May the 27th, the evening of Memorial Day. There were no injuries. There was a complete loss of the center. It was invisible to the hospitals because of the design, and sometimes that has been by design and sometimes we've been just very lucky with the way we have set up our system, but it has made us very successful, but it did take over seven months to rebuild that center.

What are the lessons learned? No two disasters are the same, one plan does not fit all disasters. Planning and the blood infrastructure are critical, but the bottom line is when the disaster itself occurs, it's blood on the shelf, and as Dr. Schmidt so appropriately said, it's the donors who donated in the few days before who are the real heroes.

Helping victims and healing donors are two sets of problems. They are each different, and it's the healing of the donors that we at the blood center level must really learn how to do a better job.

Back-up and redundancy of everything, power, fuel, supplies, reagents, information systems is critical.

Multiple customers emerge. We think that we know who our customers are. Well, the nondonors emerge, volunteers, businesses, the media, people that we don't normally have as the everyday customer sudden emerge.

Our philosophy, Point No. 7. We now operate as though there will be a disaster essentially every day. That is how we plan. And for the future, as I pointed out, we intend to increase our blood supply up to 21 to 24 days. Let me show you how we intend to do that.

The current blood use in our system we supply now 79 hospitals. We use about 9,500 red cells, this is actual usage, per month in our system. Our current availability, 14 to 17 days, means that we have somewhere between 4,500 to 5,500 red cell units in our system at all times. We're proposing to increase that availability to about 6,500 to 7,500 red cell units.

The way we intend to do this is, obviously, we already have a frozen blood program, but we're going to do this differently. This is being carefully designed. It is being worked on at the present time. We intend to add about 2,000 units of frozen red cells, all Group O, that is, O-pos/O-neg, we're going to store 1,000 units in two different sites, each 100 miles away from the main center so that the blood will be diversified. We're going to integrate the use of these red cells into our regular system so that we will use about 500 units--this is the plan--500 units per year so that we will rotate this 2,000 units over a period of 4 years.

We will not charge any additional fees to our hospitals so that they will look, in a sense, as though they are liquid units, and we will use the new system recently announced by the Haemonetics Corporation, which allows us to have a closed system and then a 14-day shelf life for the frozen deglyceralized units.

We are setting up a secondary command center at the new building that we've just completed in Lawton, Oklahoma, and putting one of our main frame computers in that building, trying to be prepared to handle any kind of potential future disaster.

Thank you.

[Applause.]

DR. BRECHER: Thank you, Ron. We have a couple questions.

Jay, do you want to go first?

DR. EPSTEIN: Thank you, Ron. Clearly, you have a lot of experience and insight to impart. I just wonder if you could comment on the process of educating the donating public. And, specifically, what is the relative utility of messages at the time of disaster versus preparation of the community on how to respond? Because what struck me the most on the 11th was the overwhelming demand to permit people to donate. Centers everywhere were, you know, pleading for the permission to do this on an urgent and a massive basis, and it was just an overwhelming social pressure.

DR. GILCHER: You're absolutely correct, Jay. It is an overwhelming social pressure. And trying to educate the donors on the front end, we have not successfully done that. We have been very successful in educating Oklahomans on the importance of donating so that we, as you know, have a very good blood supply virtually at all times. And yet it's very clear that there are people who literally come out of the woodwork, who are not part of the regular donor base.

I have a slide that I didn't put in here that I call "the thermostat level," and different people have different levels at which they will respond. We have our regular donors who respond, fortunately for us, all the time at a certain level. But when the disaster occurs--and let me say, it's a perceived disaster by the individuals, and that is heightened really by the media. The media drive it. And so we have to really work closely with the media. The media can just overwhelm the number of donors that are coming out, and we have had to ask the media to stop.

I'm sure that happened everywhere in the country, but that's been one of the big issues, that the media perceive themselves as the experts--and I don't mean this in a negative way. They perceive themselves as the experts when the disaster occurs, and they put this demand out, because they perceive that there is a need for blood, but they have absolutely no idea of how much blood is needed, and they're driving the donors. People are hearing this: "Donate blood, donate blood." And so they turn out.

We still have a lot to learn about how to handle that.

DR. CHAMBERLAND: Ron, a couple questions.

One is, after the Murrah Building and then the World Trade and Pentagon disaster, can you comment on what went on in the community, in the surrounding hospitals in terms of what you know about blood donations at hospitals in your area? For example, we have heard that another problem was that there were a lot of collections going on at hospitals, again, to meet this, if you will, demand that people had in terms of the need to donate. And, in fact, a lot of blood collection centers couldn't release their inventory to hospitals because the hospitals had collected more than they usually did on their own.

And then, secondly, I guess I wanted to encourage you to continue to collect the data on your approach to donors who showed up after September 11th in terms of collecting a sample and then actively following up to arrange donation at a future date. I think it would be extremely interesting and important to learn what proportion of people accepted that offer to donate a sample, what proportion of people did follow through on a subsequent donation, became regular donors, et cetera. I think that would be very important, that we might be able to learn from that.

DR. GILCHER: The first part of the question, again, was?

DR. CHAMBERLAND: I'm just curious, because the Oklahoma Blood Institute is obviously such a well-known facility in your area. I'm just curious what information you knew about what went on at the surrounding hospitals in terms of collections. And then does that impact on what you deliver to them?

DR. GILCHER: We're very fortunate in that, again, by design and by luck both, we are the only facility that collects blood, which means that none of our hospitals have that capability. So that both the hospitals, the media, everyone looks to us when there's any kind of disaster, and they will send--I mean, everybody comes to us.

For example, with the World Trade Center, something that we learned was that we couldn't operate our multiple donation centers. We have five in Oklahoma City. We shut them all down. We went to the new Convention Center and said, Can we set up our total mobile operations in this building? And they said yes. And we were much more efficient in terms of collecting blood and handling people by doing this. So we went to one central large building, and we collected blood there and shut down our multiple donation centers.

That made some people angry, but it made a lot more people happy in terms of being able to be drawn. Again, we were overwhelmed by the total amount of blood.

As far as the samples, that is something that we are assessing, and we think it's going to be, at least in our system, very good because what we're trying to do is build that relationship, the bond with the individual. And if we had--and we have done this in the past, so we have that data, where we've said we've got enough blood, we want you to give us your name, and then come back.

When we did that and we called those people, the return rate was very low. We thought we might build a stronger relationship by getting samples--and, by the way, we ran full testing on those samples. So now, in a sense, they become a repeat donor. And we were able to, in a sense, screen out those individuals without an actual donation who have positive test results, so that the people that we call are very likely to be donors with normal or negative markers. But that's data that's in progress of being collected, but the response from our telephone calls to those individuals has been very good.

DR. BRECHER: One last question.

MS. LIPTON: Ron, actually, you just--I was going to ask about the return rate on these donors, too, who you took samples from. But it also just struck me, one question: When you take the samples and if someone is positive, do you enter those people on a DDR at that point, or do you--so you treat them as if they've already gone--

DR. GILCHER: Yes. If we come up with positive markers, they will go on the deferral registry. We also sent the results to every one of those donors. We sent them their results, whether they were positive or negative, because it was not connected with a donation. So we're also trying to gather data on how did the individuals feel.

The initial data coming back is that--it has been very good. The donors really appreciated--I'm talking about the donors with negative test results--really appreciated getting that data. Certainly it's negative, they knew it was negative, but just having that in their hands has been very helpful to them.

MS. LIPTON: And my second question actually relates to the frozen blood inventories, and I found it very intriguing, you know, talking about setting up these repositories and then sort of, if you will, feathering it into the supply as you go along.

Do you think that's something that we should all be looking at?

DR. GILCHER: I don't know. I think that each system has to look at what their needs are. The reason we picked 21 to 24 days is that we believe that if there were any kind of major--I'm talking about a large disaster, bioterrorism, that would either take out a significant segment of our donor base or take out the main center, that we could relocate within three weeks and again be operational. So we want to have a minimum of three weeks of blood available in our system, and we don't believe that we can do that with liquid units, totally. We believe that we really need those frozen units, but what has lacked in the past has been the ability to store those units post-thaw. And now with the new system, the closed system--which means that this all has to be prospective. We can't do any of this retrospectively. It all has to be prospective.

But this is what the plan is, and I think each system should look at it to see whether that would fit for them.

DR. BRECHER: Thank you, Dr. Gilcher.

We want to stay on time, so we're going to move to the New York experience, Dr. Robert Jones.

DR. JONES: I want to test my voice a little bit, not the machine here. I'm recovering from a total voice loss of about three or four days. I can't tell you the joy, silent joy, in my blood center since that's happened. But I will struggle through.

I want to thank the committee and Steve for the opportunity to share our experience. There are certainly trends developing here on many of the things. I will echo things that have been said here already.

But the first thing I'd like to do is to ask people in the room, just by a show of hands, how many people have visited Ground Zero?

[A show of hands.]

DR. JONES: A good number so far. I would encourage all of you to do that just so that you get a handle, a sense of the enormity of what happened.

I don't have slides or pictures of the disaster. We all know what that looked like. But I want to share with you first my personal experience of visiting Ground Zero about three weeks after the event, because you really can't appreciate from the pictures on television what it looks like.

Now, when I visited there, it was three weeks, and there was still a pile of rubble about seven to ten stories high, and you see that on television. But what you don't see are things around it. First, there's smoke coming out of the pile, and what struck me was when I learned about what that was all about, that was actually the heat generated with all that mass falling so quickly and being compressed, that the core was actually burning at something like 1800 degrees. So that was a pretty remarkable factoid to learn.

Then as you looked around the scene, you saw the collateral damage, which you also don't see at all on the television pictures. For example, there's about a 60-story building, this whole glass/steel building, that has a gash that's about 50 feet wide and 50 feet deep that goes from the 35th floor down to the ground, where one of the corners of the World Trade Center just sliced right into that building. It's still standing. Actually, they say it can be rebuilt.

Now, if you visited today, which, again, I encourage you all to do when you're in New York--spend money while you're there, too, please. What you see is a hole. It's a deepening hole. It's still filled with rubble. And what it looks like is a wound. It is a wound. It's a wound that's still being cleaned before it can heal.

The citizens of New York, the people in our area, were wounded. They're still recovering. And I think you'll see some of that in the slides that are coming up.

Well, to start off the talk, the title has several pieces to it, and the last one, I think, will add to what we've heard before and how the disaster impact continues, at least on the blood care system.

Day one, very much like what you've heard before, although I must say the intensity was somewhat magnified, as you might imagine. We learned of the attack like everybody else did. We had a very quiet day. It wasn't a routine day because we had 120 of our employees in our Center East facility where our corporate headquarters are for training that day. It turned out that was good and bad. We mobilized those folks right away to help us collect all the blood that we were going to be collecting.

We got organized. I share Ron's experience. My first thoughts were: Now what do we do? And it turns out that everybody knew what to do. They just jumped right into action. There was very little coordination. We had a disaster plan. We're still altering it as we go, as Ron said. But it was clear that our disaster plan wasn't fit for this disaster. Our disaster plan had actually been designed around Y2K. So we had to do more with distributing blood across the system.

Our first priority was to supply the hospitals, needless to say. We sent out 600 units to the hospitals that were in the immediate area right away. Never heard another request from them. We did contact them every hour for the first 24 to 48 hours just to see what was going on.

The donors appeared almost instantaneously. I'd say within an hour our auditorium--which those of you who have visited us know is a fairly good-sized auditorium. It was filled, overwhelming, overrun with people wanting to donate blood. And within about three hours, the line at the Center East facility was all the way around the block, a Manhattan city block.

Our biggest issue at first was managing the crowds, and one of the things we did right away, I recall I had to go up to Fox, which is about a half a block from us, Fox TV, for a report for them. And as I came back, I saw the lines around the block. It was the first time I had actually seen what happened to the World Trade Center. When I saw those buildings going down and I saw these lines around the block, the first thing I thought was: We're not going to need any blood for that.

And so I saw these lines around the block, and I said we've got to do something about this. So the first thing we did was to say to all the donors in all the lines everywhere across our system, we're only going to take Type O an Rh negative donations. I thought that would really cut the lines back. It didn't do anything.

As I said, we were in very frequent communication with the hospitals and other blood programs about their blood needs. We knew by that afternoon we weren't going to need any blood for this disaster. I think Ron pointed out--and this happened to us, too. Because the donor response was so overwhelming, even though we were trying to push back as hard as we could, the capacity to process and test was overwhelmed. So we lost platelets. Around day six or seven, we had a severe platelet shortage because none of the platelets were tested.

We learned very quickly about managing the donors, getting them information. Our logistics, we had to make some alternations to what we usually do there. We had troubles with internal communications because those of you--I know many in the room were trying to call me, and our phones were out. There was such a massive, overwhelming use of the telephones that the telephone lines were down.

We were lucky. We had e-mail for about the first 48 hours. Then that went down.

We were certainly in close association with the hospital associations, number one, our Greater New York Hospital Association, because one of the big issues that was arising was that lines were forming outside of hospitals, and the hospital CEOs would look out the window and say, Oh, my God, we've got to do something. So they'd go to their blood banker and say we've got to start collecting blood from all these people. Most of these are hospitals that don't really collect blood. Even the ones that did didn't know how to handle these crowds. So we were getting--they were all calling, the hospital association to call us to get us to send teams to go help them draw blood, while we were already overwhelmed.

It took a while to get those conversations in the right direction, and that's one of the things, when we think ahead of time, to understand that ahead of time.

I mentioned there were problems with telecommunications and e-mail. The most reliable--I think everybody has this experience--are radio telephones. Maybe satellite phones will be the replacement for that.

Internally, we had probably three, four times a day internal conference calls across our system to connect with all our regions. We're a decentralized system with five operating regions.

Our hospital communications were primarily the responsibility of our regions. As I mentioned, Greater New York Hospital Association with myself and corporate VPs--like Ron, I became much more of a spokesperson to the media and to the public that was connected at the association level. Our PR people handled most of the media.

We managed to communicate with other blood centers in the area via our central operations and corporate offices. We have a group that manages the inventories since we have large dependencies on places from all over the world. We have an operations group that is our sourcing group. So they were in contact with the other blood centers, ABC, ARC, AABB, whoever. Everybody was calling us, of course.

And then the community and the donors, we tried to keep those communications being regional, although with the press, like television, which does broadcast over the entire area, that was also a corporate function.

This is what happened during the first week. On 9/11, you can see--these are actual collections and what is expected. These are what we usually would expect to collect on that day, and you can see there was a little bit of an excess.

I mentioned to you the type prioritization we did initially. We were successful at that. Our type mix went from--we're usually running a type mix of about 47 percent, and on 9/11 it went up to 52; 9/12 it was 58; and then progressively over the next several days it went to 60 percent. This turned out to be problematic later, and I'll explain that to you.

What happens when you start returning to "normal"? And I use that in quotes because we still haven't returned to normal.

First, we obviously overcollected and oversourced. Everybody wanted to send us blood, and actually, I think we were lucky that the airplanes weren't flying for a few days because we would have gotten a lot more than even we could have handled. So we were overcollected and oversourced, both domestically and our euro blood partners, they were calling us. Of course, they couldn't fly overseas, but once they started flying, they started flying it in.

Our drives and our fixed sites were running to 130 percent of expectation, and this went on for probably three or four or five weeks, despite the fact we kept pushing them back and trying to make them have appointments in the future.

The inventories exceeded need certainly over several weeks by more than 100 percent, and the demand was substantially reduced, and this was very true in the Manhattan hospitals. You can imagine there weren't a lot of people who wanted to come into Manhattan hospitals over the first few weeks to have their elective surgery. And so their censuses are still down, and that gets reflected in our distribution to them.

As mentioned by others, we made every attempt to postpone individual and group drives in the future. At that point in time we were looking at December and beyond. And we had all kinds of new people coming to us. New people wanted to do drives, and they wanted to do them right away, and we just couldn't accommodate them, nor did we think it was appropriate.

Now, here's a really ongoing problem. Many drives were lost from employee and business displacement. So if you come to the World Trade Center Ground Zero, you will see there is a big hole. That's where lots of people used to work; lots of businesses and companies used to be in that area. They're not there anymore. Now, many of them have moved out to New Jersey or wherever. Some of them just disappeared, and many of those we ran blood drives in. So Manhattan in particular, our New York Blood Services Region, is losing at current count about 25--has lost about 25 percent of its donor base. This is how the disaster continues.

So we have a huge rebuilding job, not only of the World Trade Center but in our donor base, in New York Blood Services.

We're also seeing, as I'll mention in a minute, the economic problem. You have to remember that hundreds of thousands of people were affected here. Hundreds of thousands. Only 3,000 people died--that's a lot of people, but hundreds of thousands of people have had major social and economic disruption as a result of this event. And that, believe it or not, impacts on blood donations.

We had tremendous financial losses. I think we did receive something from HHS, and we certainly appreciate it, but not near the magnitude of financial losses, both from decreased revenues--I mentioned to you the distribution that was down--plus increased expense. Then we outdated a ton. So overall our financial losses are in the range of $4 to $5 million. That's a lot of money for us.

Well, this is what the inventory did. Now, these were projections back here, and they've been borne out to be very accurate. As you can see, here we are before September 11th cruising along at our usual four- to five-day, thinking--we're feeling pretty good about our O positive supply. And then, boom, it's going up here, and then it starts falling off as the drives start disappearing and the donations started to--and the outdates started appearing in here.

Now, Karen and I think some others have mentioned--and Ron--how do you get these people back? Because we had thousands, tens of thousands of people who showed up and because they weren't O positive or Rh negative, we asked them to come back. They did pledges. They signed up. They'd do anything at the time.

Our yield for those people who did not donate--and I tell you, we have worked at this. We send them cards and letters. We call them on the telephone. We send carrier pigeons. We do whatever is necessary to contact these people and plead with them. Ten percent so far is the yield.

Now, so far, in terms of first-time donors, people who had never donated before, at least by our records, and they came to us during the first week--actually, I think this is from the first two weeks. We now, of course, are tracking them: 4.5 percent of them returned. This is the staffer phone calls after letters, after whatever.

I mentioned drives lot from the disaster area. Now we're starting to also see the drives being lost due to the failing economy and what we call donor apathy. The failing economy is much more easy to document and understand because when companies are downsizing people, which they are big time in our area, they don't want to have blood drives. Or when they have blood drives, people don't show up because they're worried about whether they're going to get a pink slip, you know, rather than a thank-you card about their blood donation.

I mentioned outdating of supply. That was a big, big problem for us, but it was just simply unavoidable. There weren't enough transfusion recipients for this blood.

And the inventories, when we--I showed you that chart. We were riding at about a 40,000-unit inventory--which for us is huge--for weeks and weeks, maybe two or three months. Then it started dropping off precipitously as this outdating started coming into play, and I'll show you the donation rates, which are now really scary. And so our inventories are now in the sort of 12,000 to 14,000 range. So we go from 40 to 12 or 14.

We have a big problem with Type O--I think everybody is having that at this point in time--and Rh negative.

Well, we certainly weren't prepared for this outcome, and I think as we look in the future--certainly the ideas I've heard from the first two speakers--we must understand what a huge mistake it is to do this again. Huge mistake.

All the problems we had related to the massive and unprecedented number of donations. I mentioned there were testing issues. There were processing systems that were overwhelmed. It's like you have a pipeline--we all have a pipeline nationally of how much blood goes through our pipeline. And there's some ability to expand. This went way beyond that. Way beyond that.

We had delays that led to losses of short daily products and red cells. Lots of red cells were lost, even before they got on the shelves.

And then there was the potential for safety issues. I know everybody was working really hard and working overtime everywhere. We test for the Red Cross. We know they were working overtime. When you get people working like that, there are going to be more mistakes.

Now, these are just brief things to mention. We had lots of comments, questions from our hospitals about training because they want to be prepared for the next time this happens. They want to train their hospital personnel to collect blood. And we said, okay, we'll be happy to work t you on that, and we will be doing that over time.

Transportation. We had no problems with transportation. As a matter of fact, in Manhattan, there was nobody on the streets, so you could move anywhere you wanted to.

Now, there was a bit of time where the city was sealed off. The police were just incredibly helpful and cooperative, and they moved us around wherever we needed to move.

Now, there are scenarios, obviously, as Ron mentioned, when there's all kinds of debris in the street. But we certainly didn't need to move to Ground Zero, so that was really where most of the congestion was.

And staffing, we've been in a staffing ramp-up for three years, anyway, because of the euro blood situation, but it even shows, you know, what we can do and what we can't do. So we learned a lot about staffing internally from this event.

Here are some lessons. Much has been said just in the last couple of minutes about the need, social need, the healing, for donors. There is a social value of blood donation which we saw probably in an unprecedented way, and we have to understand that that's there, but collecting blood is not necessarily the best way to meet that need. So we've got to do some brainstorming and some thinking about this. How can we meet that need without clogging up our system and causing the disaster that we're now dealing with?

Community and industry coordination and communication. I think this is a very, very important--you know, I would certainly salute what Ron says about the best preparation for disaster is blood on the shelf. But after that, you should design your collections response to medical need, not to the social need. And there's an inter-organizational task force that's been working on this. It's not rocket science. I think what we're going to end up with is the military's recommendations of, you know, somewhere between two and four units per casualty, and just take a bet and say, well, if we understand how many casualties there are as fast as we can, and then try to design a collection response around that.

Safety issues I mentioned. I can't mention that too often, though, because nobody thought about that. We don't know, you know, whether what happened here--because there was so much chaos, but I think we can understand that when people are overwhelmed like that and a system's overwhelmed that there could be safety issues.

There's clearly an opportunity for public education. They're not too interested in this right now, I can tell you that for sure. But, you know, this response--we talked a lot to the people in the lines. We showed them movies and all sorts of things about blood donations and had a real good time, and I think we educated lots of people, because they said, We had no idea you were here. So that's an opportunity.

Then the opportunities all of us have felt to engage a larger and now sufficient public to assure our blood supply of the future, it feels like sand going through our fingers right now. I'm sure others are having that experience. Maybe we're just too big and we can't get a hold of this. But it's very frustrating.

Well, here's a chart we're really proud of. This is what we looked like before September 11th. Now, we have some special pressures on us, as probably many of you know in this room, and since this goes from April '99 up until August, end of August of 2001, what you see here is our ramp-up plan to replace euro blood. This is an unprecedented increase in collections. We're going up at a rate of 11 percent per year here, a third in three years. Nobody has done that before, sustained. I'll be happy to hear about it and hear what they did that was something different than we did.

The arrow here is a marker we always have in mind. That's May 31st of 2002 when the first phase of CJD deferrals goes into place. So you can see there's a very nice, tight line here--this is a March-April zoom; I think everybody had that--and a very tight, predictable line for our ramp-up.

Here is what happened: September, October, November, December. These are three points, January through March, which are projected from our current, what we call efficiencies. That's the numbers of people that are showing up for our drives given our expected. So we're very good at projecting this, and right now we're projecting these kind of numbers. So that's pretty scary.

I don't know what other people are doing, only anecdotally. I know that--I hear from other blood center CEOs that they're having very serious problems with blood donations. They attribute it largely to seasonal, but I don't think they watch it as close as we do. We're like the canary in the coal mine here. Nobody--we watch this every hour. Here's May 31st again. So we're hoping we can get back up on this line so that we can feel more secure about this arrow right here.

Here are some more lessons. Much as we'd like to hope and pray that this would be true, September 11th did not solve the New York City area's or the national blood supply problems. We were all euphoric, I think, in the first couple of months. We thought, Wow, look at this; there's no problem here. But if you just remember those curves I just showed you, there's a big backlash, and this is not new. These are things that happen after appeals, after these kinds of disasters.

Remember that there is a social versus a medical value of blood donation. We must focus on this in the future. If something like this ever happens again--hopefully it doesn't--we must remember this: that there are safety issues associated with overcollections, that we should have better coordination of public messages in collections. One of the goals of the task force was to--what is the central body that would sort of coordinate and create teamwork around these kinds of things if they ever happen again? And at least for now we've decided that AABB is common to all the collectors, so that that would be the coordinating focus.

Again, I can't emphasize this too much, it is certainly a trend we're hearing. Blood collections in future disasters should be tailored to medical need only, and also that these disasters tend to create secondary disasters. And I think I showed you one, that it doesn't just come back to normal, especially when we've got something on this scale and intensity. And we need to figure out ways to manage that.

There is in my mind--and I've told this to a lot of people. I believe that our blood supply right now and blood donor base is tremendously unstable. And the question we have, ask ourselves every hour, is: Will the instability and shortages related to that extend into the period of vCJD deferrals? Remember those arrows. It starts on May 31st. I don't have the answer to that question. If I were a betting man, I'd say probably yes. The good news is that I'm not a betting man, and when I do be, I'm usually wrong.

So that's our experience. Again, I want to encourage you who go to New York, spend money, but also visit the site. It's a human experience, one that you'll never forget.

Thank you.

[Applause.]

DR. BRECHER: Thank you, Dr. Jones.

We have time for a few questions. Maybe I could just begin. You said transportation was not a problem. What about testing of all those donations and the supply of reagents to the New York area?

DR. JONES: We ran out of bags the third or fourth day, but that was the last thing we needed was more bags. Our testing transportation goes bidirectionally, one to Boston and one to--I mean, once you got outside of New York, there wasn't a transportation problem.

So we ran into no transportation problems. Now, that's not to say that it couldn't happen in another set of circumstances. But that was not one of the issues for us.

DR. BRECHER: Dr. Popovsky?

DR. POPOVSKY: Dr. Jones, much has been written, or at least said, that post-September 11th new demographic bands appeared in the donors who came in the first few days, particularly younger donors. Your data would suggest that you're not capturing those younger donors.

DR. JONES: I don't really have the figures with me on the demographics. We may have seen a lot more younger donors and some more minorities. But what it looked like to me, just anecdotally in the lines--and, again, I don't have the data with me. They looked like our donor base just on a bigger scale, much bigger scale.

There were some interesting experiences, I have to say. The person who's now mayor of New York was a donor. He came on September the 11th, couldn't get in the door, and he didn't make any--he just stood there. This is sort of an advertisement for him, I'm sure, but we're happy that he's mayor. Then he appeared at 7:30 the next morning in the line. Never said a word to anybody. Some other mayoral candidates did, incidentally, were quite visible, and cadres around them, but our current mayor, the one who won--so there were lots of interesting stories, and people, really, they appreciated the experience. For one thing, they didn't have anything else to do. They didn't have anything else to do, so they wanted--you know, they were all New York Blood Center

DR. BRECHER: Okay. Thank you.

DR. JONES: Thank you.

DR. BRECHER: We're going to stay on time, so we're going to move to Mr. Gary Ouellette from the Chesapeake and Potomac Red Cross.

MR. OUELLETTE: Good morning. My name is Gary Ouellette. I'm the Executive Directors of the Greater Chesapeake and Potomac Region. Our headquarters is in Baltimore, Maryland, and our territory encompasses all of Maryland. You see here parts of southern Pennsylvania, parts of Northern Virginia, and, of course, Washington, D.C.

We are what I would call "the other ground zero," and I would like to share with you some of the things that we experienced.

Our territory is 8,000 square miles, which is really considered a rather tight geography, and I think that worked in our favor.

We have annual distributions of about 324,000 units of blood, red cells per year. We service over 80 hospitals in the territory that I showed. We have ten trauma centers in that area, and we conduct approximately 25 operations per day. This is our fixed sites as well as our mobile operations.

I'd like to talk to you a little bit about our experience as a local blood center. Later, Dr. Jerry Squires will talk about Red Cross on a national basis. But as the local blood center, we experienced some things that I want to share with you.

As we all did, we heard about the World Trade Center attacks in the morning. Everyone turned on the television sets and watched the second plane go into the second tower.

As part of the National Red Cross system, to move products from one area to another in case of natural disasters or otherwise, I had the responsibility to phone our national office to let them know what we had for supply, which we had a very good supply at the time, and to indicate that I could dispatch product to New York City, I could put it on a truck, and then we could re-dispatch while it was on its way, so at least being within five hours by land we could get product there.

While I was talking to the vice president in Rosslyn, she was looking out her window, and while I was speaking with her, she saw the explosion at the Pentagon and said, "Oh, my God, the Pentagon just exploded." And, obviously, that changed my perspective and certainly my charge dramatically, because now this was something in my own territory that I needed to deal with.

We immediately pulled together my senior management team. We did an inventory assessment. We have three to four days' inventory, which was a very comfortable level. I want to echo what we heard earlier. The real donors--or the donors that were the real heroes were the ones that donated on September 5th, 6th, 7th, 8th, and 9th, because it allowed us to have product on the shelf at the time of the emergency. And I think that's a critical element that we need to talk about as a group to ensure that we always have a good supply.

We discussed--one of our--we had two primary issues that we needed to deal with. Coincidentally, on the day of September 11th, we were running a blood drive at the Pentagon, and I had staff inside the Pentagon, and we had no indication as to whether they were okay or not. This was a little bit disconcerting for us. All of the phones were scrambled. We were not able to get any communication, even by cellular phone. So that put us on edge a little bit.

We also attempted to call all of our hospitals in the Washington, D.C., area that were trauma centers as well as another hospital in Northern Virginia that has a large emergency room. We were not able to get through at all, so we decided to take action regardless of that.

We immediately shipped 600 O positive units to designated hospitals surrounding the Pentagon, and I'll show you a map of that, and I'll give you an idea where we dispatched to. But we coordinated our efforts with the mayoral offices in Baltimore as well as Washington, D.C. They were extremely cooperative. They provided police escort for our trucks to get down to our hospitals. And I'm very proud of this factor: At 10:30 in the morning is when the Pentagon was hit. Before noon, we had 600 units O positive in four hospitals surrounding the Pentagon, and we felt very proud of that factor.

This is a map of the Washington area. Obviously, here's the Pentagon here. We had three trauma centers that we sent blood to immediately, also Fairfax Hospital, which has a very large emergency room, and we also sent additional units to Walter Reed Army Hospital to assist them as well.

What action steps did we take? We finally made contact with our American Red Cross staff, but it wasn't until 1:00 p.m. that we were able to talk with them. And they were safely evacuated. In the meantime, we had identified where they were in the Pentagon, so we knew they were not near the area that was damaged. So we felt a little bit more comfortable with that.

We set up a situation room at our blood donor center. It was manned, literally manned 24 hours a day. And we set this up so that any management person or any staff person could go to the situation room and we knew exactly what was happening at any point in time, as opposed to having multiple people with information and trying to figure out who knows what. We had one central area, and I think that worked very effectively for us.

Also, before midnight on September 11th, we had 1,100 units of O positive and O negative delivered to our center, and this is part of the Red Cross network where other Red Cross centers sent that into us by land--because obviously nothing could fly--but this worked very effectively. So we had emergency backup to us within hours of the situation.

Other action steps we took, as I said, we have 25 mobiles and fixed sites that we run on a daily basis. We consolidated our efforts. We opened only our fixed sites and ran no mobiles whatsoever.

Now, there's good reasons for that. One is that it's the most effective use of staff, and I think we heard that from some of our other speakers, to have large operations and fewer of those, as opposed to spreading out your resources, although the pressure was intense from everyone. Everyone wanted to run a blood drive. People who we couldn't get to even talk with us previously called and said, We want to run a blood drive, and, by the way, be here tomorrow. So it was pretty intense.

It's also easier to stock supplies in fewer places than it is to try to spread it out throughout multiple sites. We had more effective regulatory oversight because if you have fewer operations, you can have your regulatory and quality people at those sites to ensure that everything is being done and done well. And, also, it helped with the media message because the more complicated the message is, the more confusing it gets for the media and the general public. So by saying that we had our fixed sites and we could say that those fixed sites were going to be open every single day, people knew exactly where they were. It was the same message every day, and it was far less confusing than trying to say what community we were going to be in on that particular day.

We also set up two operations--we have a blood donor center in Washington on I Street. We shut that down, and we opened up two blocks away at our Red Cross headquarters, and we had two large rooms. This is the ballroom at our headquarters where we set up 12 beds in there. It was a much more comfortable situation because it was larger, we could move people around easier.

This is another large room at the Red Cross center. Those are the Tiffany windows in the background.

Our nation's leaders were asking the public to do three things. They said that they wanted everyone--or encouraged everyone to pray, and I think we probably all did a fair amount of that; to donate money to help those people that will be needed support; and, of course, to give blood. And we all heard a number of times already that not much blood was needed, but our public leaders were out there saying give blood. I think that's good, and I think it hurt us. And I'll share a little bit of my thoughts on that.

The impact on what we call donor deluge, which is exactly what it was, and, in fact, one of our donor sites that usually collects 50 units of blood a day on September 11th had 1,600 people show up at the site. And we saw similar numbers at all of our other fixed sites. So donor management was really quite a challenge for us.

Also, with respect to staffing availabilities, hours worked, fatigue, we had to make sure that we gave our staff breaks at appropriate times in order to be able to service the donors most effectively. With respect to confidentiality, it always becomes an issue. The more people you have in a room, the more risk you have on the confidentiality issue, which is exactly why it was better to be in our donor centers where we have confidential booths for health histories.

Process flow and our donor flow, we had volunteers that were working up and down the line, taking names, addresses, pone numbers, encouraging people to please be on our list and we'll call you when we need you. But, quite honestly, people would not go away, and I think we heard that here, and I'll bet everyone in this room who works in a blood program experienced that as well.

I had one gentleman that was in line, and I was working the line and talking to our donors. And I told him that it would be a five- to six-hour wait. He looked me in the eye, and he said that, "If people in New York can sit on the rubble for five or six hours, I certainly can sit here for five or six hours." And that was the emotion that ran through every one of those people who were waiting in line. They wouldn't go home.

With respect to manufacturing, that was another challenge for us. We were able to keep up with it. We ran our two shifts in our labs, and fortunately we were able to keep up. Data entry became an issue because you have to enter all your information, and that's something that we really hadn't planned on. And that was not in our contingency plan. It is now. But we didn't have it set up, so we had additional data entry people to come in and put the information in the computer because you can't release the products unless you do.

Also, product storage became a challenge. Now, we were fortunate that we did not have to--we were able to use the storage that we had and not overexceed that. We had just put together a capacity plan about two months before, and this was an opportunity for us to see just how our capacity plan would work. And, quite honestly, we had more capacity than we thought we did in our plan. But we did line up some refrigeration trucks just in case. And this was not in our contingency plan--it is now--to ensure that we had some backup for refrigeration.

Volunteer management. This was a challenge for us. We had a lot of people that wanted to volunteer. It was more of a challenge with the people who wanted to volunteer that were doctors, nurses, and technicians because, of course, they were doctors so they should be able to do a phlebotomy. Well, it doesn't work quite that way. And it was a challenge for us to respectfully talk to our physicians about how they might help. But our volunteers that were non-regulated volunteers took names and addresses and phone numbers and talked to the donors, served refreshments to our donors that were waiting. We made sure we had television sets everywhere so people could watch what was going on in the news. And with our clinical staff, some were permitted to do physical findings, blood pressure, temps, those types of things, and that's where we used our doctors, nurses, and medical technicians.

But we wanted to make sure that they were credentialed people if they were going to do this, so they had to show credentials, confirmed through photo ID, that, in fact, they were what they said they were. A valid ID from the institution, we asked them to display that while they were working at the blood drive so people knew where they were from and who they were, taking their name, Social Security number, address, and phone numbers, tasks performed, the dates they performed those tasks. We made them sign that so that it validated exactly what they did and when they did it because we wanted to make sure we had clean records on this. And also with respect to training and documentation, we trained them on our blood service directives, and they were not allowed to do a task until they were signed off and released a task. And I think this is very critical when using volunteers to make sure that they are appropriately trained before letting them loose.

Now, with our physicians--before I get to this, with our physicians we talked with them about doing something a little bit different than what they usually do. And what we asked them to do is to talk to the blood donors and talk to them about what blood is used for and how important blood donations are. And I'll tell you, this was the most amazing thing because--I know we have a lot of doctors in the room, but for those of you who go see your doctor, you usually have about 15 seconds with him, he says, "Thank you very much. Next?" And this is an opportunity to have quality time with a physician, and it was unbelievable. The donors loved it, and the physicians loved it. And we had physicians coming back for two or three days because they enjoyed talking to donors and talking to people. So this was a very effective use of our physicians. They were helpingout, and everybody was very happy with that.

With respect to processing, all the products that we collected and tested were testing and manufactured in a reasonable time frame. Within a few days we had all our tests done. Part of that is we have a national testing lab system. I'm fortunate enough to have my testing done in Philadelphia, which is only an hour and a half away from our headquarters by land. So I was able to get testing samples there in very short order and turn-around. Although we did have some challenges with platelets, as was mentioned earlier, we were okay, even though we had a couple of times that it was tight. It's amazing how you can have so much and yet sometimes have so little of some of the things you need.

Supplies swelled from a three- to four-day inventory to a 10- to 15-day inventory. We had local product outdating, which is normally 2 percent for us. Our outdating went up to 3 percent. Now, we are an importer. We did an import during this time, and that's why our outdate didn't go out quite so high. But we also had--because our refrigerators were so full, I assigned two people and their full-time job for--actually, it was about three or four weeks. Their full-time job was to make sure stock was rotated, because the most critical thing was making sure that we got the oldest stuff out first, and that product management I think served us quite well.

We also will attribute some of this outdating to the fact that in the first three days of our collection, 60 percent of our donors were first-time donors. Now, we do specific type recruitment. We do it through a telemarketing, and we make sure that we get the right types that we need at the right times. When you have 60 percent of them being first-time donors, you have no clue what their type is. So you're going to collect blood that you know you're not going to use. There's going to be a lot of ABs that come in, a lot of As that come in that you're just not going to use. So that was a challenge.

To ensure the quality of our operations, our quality assurance group and quality systems staff were assigned to potential hot spots. Now, actually, I put that on here, but all of our donor centers were potentially hot spots only because of the number of people that came in. So we had quality staff, and their job was just to walk around and make sure we were doing it all right and that we didn't have people wandering around where they shouldn't be, and that the staff were also getting their breaks so that we could head off fatigue.

Here's what our collections looked like. We normally collect about 1,100 units a day. On September 11th, you see greater than 2,200. September 15th is when we--or, 12th, rather, is when we crescendoed at greater than 2,500 units; on September 13th, 2,300, with a 60 percent first-time donor rate, was incredible.

Now, we're looking at this and saying, God, if we can get these people back, it will be wonderful. We saw the same kind of statistics that New York saw. We're talking about 4 to 5 percent of those people returning, and that's unfortunate. But I think there's some things we can do to encourage them to come back.

We had some unique challenges. Being responsible for the hospitals in Washington, D.C., our nation's capital, I talked earlier about how our political leaders, our nation's leaders said what we need to do is pray, give money, give blood. Some of them said give blood at your local hospital, which even compounded our problem because our hospitals, most of them don't collect. They get the blood from us. And we learned that, and I'll address that in a few moments.

But at 11:00 p.m., I still had all of our staff in our strategy room. At 11:00 p.m. on September 11th, I received a call. The President of the United States requested that we have blood drives at the New Executive Office Building and the Old Executive Office Building, and, gee, we'd love to have you there tomorrow morning.

Now, our staff were dispatched to all of our sites. We were running until 1:30 in the morning that first day because of the number of donors in there. So now we had a challenge to get 20 staff reassigned to be at the White House at 6:30 a.m. the next morning. Within 15 minutes of that call, we were also supposed to have their Social Security numbers, their date of birth, and proof of citizenship so they could have security clearance. This was a challenge at 11 o'clock at night because our HR Department's closed, and a lot of the staff had gone home. But we were able to scramble and get that information available.

Dispatching equipment and personnel through heightened security is a nightmare. We went to the White House the next morning, and we had to park a block away. So we had to load all of our equipment on our trucks on hand trucks and carry it a block down the road in order to be able to get into our fixed site. For those of you who ever operate Bloodmobiles, you know the challenges that are part of that.

We also had to make sure that we dispatched our trucks at least an hour and a half before we normally do, because we had mirrors put under the trucks and we had dogs sniffing the trucks. So it was really quite a challenge being in the Washington area trying to run blood operations.

At one point around our headquarters, where we had two of our collection sites, they had actually, I think on the third day, cordoned off a 14-block radius around the White House, and our donor center was in that block. Fortunately, the back door wasn't, so our donors were able to come in through the back door. We were still able to bring people through, as well as our staff.

Other unique challenges: We were requested to be at the Senate and the House of Representatives on the 13th and 14th. We had over 500 donors present themselves there. Our region was responsible to ensure heightened blood collection awareness for the United States. Let me explain that.

We were asked and actually provided any Senator or Representative that was donating blood, if they would like, we would videotape that, and we would send a complimentary videotape to wherever they wanted us to send it so they could have their constituency see that they were donating blood and encourage blood donations. This was a wonderful thing for them to do, and, in fact, we did this for any Senator anywhere. It didn't matter. This was a time when blood donations and blood crisis throughout the United States. We would send it to whoever would like us to send it and where we sent it.

During the blood drives, we were evacuated multiple times. So here we are in the middle of a Bloodmobile, bomb scare, everybody out. So we would get out. We had one blood drive at the Rayburn Building. We were evacuated three times during that blood drive. It's pretty disruptive when you're trying to run an operation and you have to be out on the sidewalk every few minutes.

But I think what was important here is our nation's leaders did something that I thought was pretty special, and a good leader is one who leads by example, and our leaders came down and they donated blood.

Now, another challenge that we have is when we have our blood drives at these places, our Representatives and Senators have little gold pins. All of our staff know how to spot a Representative and a Senator. We have a special health history. They have special elevators. They have special everything in their buildings, right? So we had a special health history. We triaged them through. They get done and everybody's happy and they move along.

What do you do when 70 of them show up and they're all special? Well, it was quite a challenge for us, but I will tell you this, that everyone was very understanding and very patient as we went through the process.

Some stories. You know, this is something that our industry, I think, as we look at collaboration with all of the blood collectors in the United States, we have a business that we run. We have a manufacturing plant that we run. We have a pharmaceutical operation that we run. But when we talk about our donors, they don't want to hear all of that. They don't want to hear statistics. They want to hear stories. And that's what brings donors in, how important it is to donate blood and that there's real people that are receiving blood transfusions. And so stories are important, and I'm going to share some of those with you.

We had Mrs. Bush come through the White House blood drive. I will tell you that this was really kind of--this was very uplifting for our staff as well as the donors that were there. She personally went to every staff person and every donor and thanked them for the work that they were doing.

Most federal agencies hosted blood drives within two weeks of September 11th. Everybody wanted to be special and have a blood drive. This was quite a challenge for us, as we were trying to meet everyone's needs.

At the same time, we were not going to any of our communities. Now, we have a lot of people out in the communities that are not real happy about the fact that we're not out there, and it was a real challenge for us on the media side to really handle that.

We also had many Cabinet members that donated blood and, again, leading by example is important. We had national leaders, local leaders, and even some celebrities that donated. This is Mr. Ashcroft. He came in with his wife and donated. He was very patient. He talked to all of the staff and was very nice.

This was probably one of the most heart-wrenching donations that we saw during the process here. We had two of our blood donation sites, one downtown and one in Fairfax, where we had about a dozen American Airline flight attendants come to donate. And they did that in honor of their fallen colleagues in the planes that were crashed. And I will tell you that when they showed up and they started talking to the donors and thanking them for being there, there wasn't one donor that was going to go home. And I don't care whether they stayed in line for eight hours. They were not going to leave. And it was a very emotional situation, and I think the pictures tell a little bit of that story.

This is our Lieutenant Governor in Baltimore, Lieutenant Governor Kathleen Kennedy Townsend. She came down to donate, and she is a regular donor and supporter of our blood program.

This gentleman here, who stands about six-five, weighs 340 pounds, is the offensive lineman for Baltimore Ravens, who at least for the next couple days are still the world champions.

[Laughter.]

MR. OUELLETTE: No more. It's going to end, I know. But he did come in, and he was just incredible, because he came in and our staff moved him through and brought him up in front of the line, and donors didn't care. They said, oh, yeah, this is great. He's shaking their hands, showing his Super Bowl ring and whatever. And he came in and he donated, and he spent two and a half hours after he donated just talking to the people on line and telling them how important they were to come in and donate.

Now, two weeks later, we had our annual meeting, and he came as a speaker. And he said, "Well, what do you want me to talk about?" I said, "Just tell your story about what you felt on the day of the--on September 11th." He said, "Okay."

We have a room full of people, and he stands up there, a mountain of a man, I mean he is huge. And he stands there, and he's a very humble and kind individual. And he's talking about September 11th. He said, "You know, I heard what happened. We were watching television. I sat there with my family. I was hugging my children and my wife. And we were all very touched by and hurt by what happened, as we were watching the whole New York scene."

He said, "I then said to my wife, `I need to do something. I need to help some--I need to do something. I ache to do something.'"

He called a couple of his buddies, and he said to his wife, "I'm going down to the Red Cross to donate blood." He arrived at the center, as I said, but when he was making his presentation, he said, "You know, I'm an American, and I felt compelled to do something, something that helped others. And I also needed to do something to help me. And as an American, I needed to help other Americans."

Now, here's this man who's huge. He didn't break once, but tears were rolling down his face. There was not a dry eye in the house. But again, when I go back to stories and I talk about what it's all about, that's what it's all about. It's people who want to help other people. It's just that we don't want them to all come in at the same time. But it was a very powerful message that he was delivering.

Other stories. We had some staff that set up their own child care unit. The ones that had teenagers brought them in, and the ones that had young ones brought those in, and their teenagers took care of their kids. And they did this--they had us set up in our board room so they could work because they didn't want to go home and they knew that they needed to be there. Our staff worked tirelessly to meet our country's needs, and when we talk about therapeutic blood donations, they had a whole new meaning after September 11th because the people that donated not only were there to help others, they were there to help themselves, and they really had an aching need to do something special.

Also our staff were getting tired. We declared Sunday, September 16th, a day of rest for staff. One of the things that we recognized is that while everybody was at home watching television sets and watching what was unfolding, our staff weren't. They were on their feet and they were working 15-, 16-hour days, day after day after day. Well, we realized that they didn't have an opportunity to grieve as an American. They didn't have an opportunity to be with their families. So we said, "On Sunday, you'll go home and you'll hug your kids and you'll need to have some time to yourself." And I tell you, there were staff that came to me and said, "No, it's okay, I'll work." And I said, "No, it's okay, you'll go home." And it was important that we did that.

The aftermath, collections continued strong through September and October. We had collections drop off precipitously in November, December. We saw that everywhere, and we're now seeing some come back in January, but it's not as strong as it should be. It demonstrates the fragility of the blood supply. We have a 42-day product and this product doesn't last too long, and you can't have it all come in in the same day. And I think that it's important that that be the education process for our public as to just how fragile the blood supply is.

Lessons learned? We know that we can manage a 7- to 10-day supply. Dr. Gilcher, I applaud your going higher than that. That's a real challenge to be able to move that product around and be able to maintain a low outdate on that, but 7- to 10-day felt comfortable for us. We revised our contingency plan to the event driven versus department focus. That was--we had a plan that was a good plan, and everything in there was good. However, we had it set up so that we looked at each department individually when we really should have looked at the event and then the trickle down effect by department. So we have rearranged that so it's a little more practical for us.

We also learned that when our political leaders and others said, "Go donate blood and by God go to your local hospital," there are hospitals who were trying to take care of patients are inundated with people coming in the door. We now have in our contingency plan volunteers that will go out to the hospitals, take names, addresses and phone numbers and redirect people to our donor center so that the hospital staff don't have to deal with that. I had several CEO meetings with our hospital Chose post-September 11th and reviewed this with them, and they were quite appreciative of us putting a plan like this into place for them.

We now have at the ready Social Security numbers, date of birth, and everything ready so that if someone says, "Be there tomorrow and have security clearance," we've got it ready. We also maintained and updated a list of trauma hospitals with our hospital associations in Washington and Maryland. We had a hospital that I went to visit afterwards, and they said, "How come we didn't get additional products? We're a trauma center." And I said, "You are?" He said, "Yes." I said, "Well, when did that happen?" "About a year and a half ago." But they didn't tell us. So here we are the blood supplier. We didn't even know that we had a hospital that went to a trauma hospital. So now through the hospital associations we're making sure we keep an updated list on that, but that was an oversight that was a very dangerous oversight in my opinion.

Logistics of blood storage. As I said, we now have in our plan back-up refrigeration if we need it, although we didn't have to put that into place this time. And also the dedication of our staff and donors was just incredible. Our staff would have worked till they dropped. And we had to break then because they just would not stop. And our donors, and you heard some of the stories. It was just phenomenal, the people that were waiting in line.

I'd like to extend our gratitude to the many blood donors of our community, the media who were incredibly supportive through this period. They would come down to our donor centers. They would tell the story that we wanted them to tell, which was please call and make an appointment for later. People didn't pay attention to it, but we got that message out there as strongly as we could.

We also would like to thank the establishments that provided just a huge amount of food for our donors and our staff. We had caterers that were bringing in hundreds of meals, hot meals, for the donors that were waiting in our lobbies watching television, and it really helped quite a bit. And certainly all of our public officials who were extremely supportive through this period of time.

I'd like to make a couple concluding remarks here. I've been--September 11th is a day that obviously we'll never forget, and it was something like we've never experienced before. In my 30 years of blood bank experience I've never seen an outpouring of donors like this, and I've seen Desert Storm, Oklahoma and a number of other natural disasters, but nothing felt like this felt. This was a violation. People felt violated and people felt like they needed to do something. And it was a very unique situation.

We went from a system, ordinary system outdate of about 2 percent, and that swelled to about 5 percent. We had between the donors that were collected between September 11th and middle of October, we had about a 5 percent outdate on that. And I was looking at that, and I was thinking, with a lot of the negative press that has been out there with respect to blood being thrown away, that that concerned me quite a bit because I think that's had an impact on donors coming back. So we had this 5 percent, and I'm thinking, you know, I prefer to look at that as a 95 percent success rate because 95 of every 100 units of blood that we collected went to transfusing to recipients and helping save lives.

And so I'd like to pose for you a couple questions just to think about, that is a 95 percent rate versus a 98 percent success rate, a small price to pay for homeland security and insuring that we have an adequate blood supply for an emergency. And isn't that 95 percent success rate versus a 98 percent success rate a small price to pay when we had a terrorist attack, we were being told by our government, and even given dates of when there were likely additional terrorist attacks, to be able to be prepared. And also a small price to pay when we knew that our men and women of the armed forces were likely going to go to war and no one had an idea of what that outcome of that would be.

And so I think that as people who influence the public, our public leaders, our media, it's important that what we should be doing, in my opinion, instead of being critical, is to take a look and use what we learned from this as a tool to get better, but not have that tool be a hammer, because that's not going to do anybody any good. And I think that it's time for us to take a look at all of those donors that came in during this time and encourage them to come back, and thank them for what they did. But encourage them to come back, but also take the opportunity to educate them, that blood is needed 365 days a year, and this next year in our country over 12 million units of blood are going to be needed to be transfused, and we can't lose sight of that. But for us to not take that opportunity I think we're missing just a huge opportunity and we're not doing our country any service.

And so I would like to ask those people that do have the influence to encourage people to donate and to give that precious gift of life. Thank you very much.

[Applause.]

DR. BRECHER: Okay. We're running a little behind. I think we're going to take our break now and we're going to start promptly at 10:30.

[Recess]

DR. BRECHER: All right. We're going to being the second session of the morning. This is going to be the experience of government in the crisis, and we're going to begin with the experience of the FDA and Dr. Alan Williams will be the first presenter. Alan?

DR. WILLIAMS: Thank you, Mark.

The Kennedy assassination, the Challenger explosion, September 11th, we all know where we were on those days. I happened to be in off-site training, and was called back and had the rather eerie experience of finding my way back to FDA in very heavy traffic with sirens seemingly, you know, coming from all directions, and really not knowing what was next for the country, really a very unusual and eye-opening situation.

Once back at FDA we also established a situation room where we had all available staff around a single table, trying to anticipate what potential events might unfold and what the appropriate regulatory and coordinating response for FDA should be.

Obviously, one of the first things to do was to closely monitor developments, both from the media and by intensive phone contacts where possible with the New York area, with DOD, with blood collectors and major blood collecting organizations and those in the Washington area, and use that information to try to anticipate needs in the day and days to come.

We also anticipated a range of blood supply scenarios September 11th. One can view it in retrospect and certainly assess it, but on that day it was a very unknown and confused situation. We didn't know what potentially could happen next. We didn't know exactly what the casualties were in the New York and Washington areas at that time.

Based on the close contact that we established with the blood organizations, with manufacturers, with the Department of Defense and with other HHS agencies, we built that information into what was put together as a policy statement and issues late in the evening of September 11th. And this was done for really I think three primary reasons.

The first is just the situation that everything was an unknown, we didn't know what supplies would be needed, what the transportation would be to move those supplies, particularly of blood and blood components. And we didn't need what the collections needs would be and how much flexibility collection facilities would need.

The second area is that if there was a need for contingency measures in the country, we felt it was better to have them done under a framework, rather than having it done ad hoc, with calls made out to FDA as far as requesting permission to do things. So we felt it was important to get a framework out there.

The elements of the policy statement issued on September 11th covered several areas. The first is the training and certification of emergency staff measures. On the September 11th policy statement, it provided that routine trainers could train emergency staff as appropriate, using existing SOPs, that these same trainers would provide assessment of the competency of the individuals that they were training, that all procedures would then be conducted under SOP and that the training would be sufficiently documented. I might also add that each of these measures were done under the existing regulatory framework.

The second element concerns the release and use of units that are not fully tested, either due to lack of availability of the test reagents or transportation issues, specifically for required or recommended tests, use of those reagents would require an "emergency use only" label. The label would reflect the test that was not done, and that testing of course would be done as soon as possible based on availability of materials. Additionally, for nonrequired tests which would reflect primarily ALT testing, and that testing being done in the field under IND, there was a recommendation that the label carry an indication of the test that was not performed, again with testing to be done as soon as possible.

Third, shipping of unlicensed blood components in interstate commerce. We recognized that if blood from registered facilities needed to be shipped interstate, there potentially would need to be provisions for that. Again, such shipment should carry a label for emergency use only, and that FDA would use enforcement discretion in looking at these situations on an individual basis.

Fourth, product identification and record keeping. The statement indicated that records of units collected under emergency conditions should be maintained so that those units could be subsequently identified, and records of products both in blood centers and transfusion services, "under emergency use only" labeling should also be maintained.

On September 14th the information was becoming a little clearer. We were aware of the--that the blood supply needs within the New York and Washington areas had been met, that the immediate terrorist threats, at least as recognized over a several day period, were not creating unusual demands for blood and blood supplies. So on the 14th, FDA issued a revised policy statement, which is a revision of the 11th statement, which covered several of the same areas and made revisions, specifically the training and certification of emergency staff was revised to stop the use of emergency training procedures of new individuals, that emergently trained individuals should cease doing phlebotomy and donor suitability screening, and that all other use of emergently trained personnel should be stopped as soon as possible.

In addition we requested that all materials collected under emergency procedures should be subject to a quality assurance investigation within 72 hours, and that any collections found to be unsuitable would be removed from potential distribution.

Release of units not fully tested was revised to really allow for the emergent situation, that what was the problem on September 14th was the lack of transportation as much as anything, so we needed to make provision for the inability to ship samples to central testing labs and to potentially deal with the fact that reagents might be in short supply. The shipment of unlicensed blood components in interstate commerce was discontinued. That was felt not to be needed. Product identification and record keeping continued as specified on the 11th, and the use of alternative FDA registered laboratories, actually one of the most active areas that we were involved in, normally what's known as a change is being affected in 30 days as a license supplement. We made available the fact that manufacturers could change to an alternate facility and provide an indication to us that that was being done, what is normally a CDE-30.

Other activities regarding the 11 through 14th time period. There was a need to address the transportation disruptions, primarily the air carriers, and internally we took measures to assure continued availability of supplies, reagents and sample shipments. This meant monitoring the situation through the FAA and their current policies on shipment of samples when air carriage might be available, how to handle materials that were in transit. Certainly there were some shortages of reagents that were stuck in the pipeline, and we had to consider reprioritizing lot release for everything from immunohematology reagents to infectious disease test materials.

We had a lot of exchange with a lot of different entities on those days, particularly with blood centers, and what we did was formally document these experiences, because this was the first time policies like this had been issued. We had a lot of interactions. We documented those, and I think got a pretty good sense of where things worked correctly, where potential changes might be made in the future, and we have begun building ourselves a set of internal SOPs that would address different potential scenarios so that we could have, you know, at least a skeleton plan of how to react in different scenarios with appropriate phone numbers and so forth.

This is actually amazing, amazingly the first mention of anthrax in today's discussion. The realization that anthrax had been sent through the mail and passed through various postal facilities and other potential government areas was being recognized. Most of us were out at the annual AABB meeting in San Antonio. It was actually some of the FDA folks and CDC collaborators and others who met extensively in October timeframe to determine what potential risk there was regarding anthrax exposure in blood donors and potential blood donors. Through these intense discussions agreement was reached that there was no known risk for transmission from blood collected from any asymptomatic donors who may have been exposed to bacteria or spores. This was an important conclusion and supported issuance of a guidance in October of 2001, entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax."

The key elements of that guidance were that in situations of proven anthrax, donor deferral would be appropriate until the completion of appropriate antibiotic treatment and quarantine and retrieval of any end-date products was also indicated. In situations where an individual was found or selected to have colonization or a suspected skin lesion, donor deferral until an alternate diagnosis was established or anthrax-appropriate treatment completed.

Third, post-donation illness without confirmed diagnosis would be a situation for medical discretion in terms of that follow up of that donor's products and potential retrieval.

In addition, the major facilities that had known anthrax exposure, the Brentwood mail facility in Washington, the Trenton Post Office and various state and federal facilities. Being large facilities, they were, you know, had become major collection areas for the local blood centers. So there were--you know, there was recognition that potentially there had been blood drives at these facilities in the timeframe of the anthrax exposures. The initial recognition and investigation of these appropriately was done by the centers during the collection and many of these had already looked very carefully into the situation, and subsequently discussed it with FDA. FDA considered this further and pro-actively made phone calls to potential collectors in some of these areas, specifically Trenton, New Jersey, and ensured that no blood collections had taken place so that donors had donated blood during a time of potential anthrax exposure.

Subsequent to that we also had discussions with the Centers for Disease Control and managed to coordinate, including a question about blood donation in their case investigation of the actual anthrax cases, which clearly is the most efficient way to follow up that type of potential exposure.

Now, you will in depth tomorrow details about some of the FDA's plans moving into the future. I've just provided a little skeleton here and I'll say a few words about plans within the Blood Applications Division. The key elements are development of emergency response SOPs, which I mentioned. This not only refers to actions concerning blood and plasma collectors, but certainly would apply to the Hematology and Emerging and Transmissible Disease Divisions as well in terms of maintaining adequate supplies, looking at contingent measures to provide test kits and maintain a safe blood supply.

Also were actions to treat and protect affected individuals through therapeutic materials--this will be detailed tomorrow; measures to protect the blood supply in terms of specific screening or inactivation procedures, especially for bioterrorism; and we've tried to be very proactive in terms of outreach and coordination, not only with our agencies with whom we work on a regular basis, but also the major blood organizations, and I think we're very pleased to see the progress that's been made between the organizations in working with the task force and really creating a national program for emergency response.

In my final slide I'll detail some of the things that are actually occurring within the division of blood applications. We are putting together a consideration of actions to continue under the general heading of actions to assure continued supply. We're considering assessment of anticipated blood needs for different emergency scenarios, the sort of thing we're talking about this morning.

Admittedly, the U.S. experience with natural disasters and terrorist acts has had a low to moderate need for blood products, specifically red cells. One can imagine scenarios that might create more of a need, for instance, things like mail bombs simultaneously going off in different areas--those are penetration injuries--potentially could create a red cell demand that exceeded local supply. We don't know. We haven't experienced it in large scale in this country, but it's a readiness consideration.

What would happen in terms of a radiation attack, a chemical attack, some other type of traumatic attack? Just anticipate what the blood needs might be, and certainly other elements of the national response are doing the same thing, particularly DOD, and I think all this is certainly going to be valuable information to have if we ever need it.

We've also been thinking, like the major blood collectors and the military, about the optimal design storage and movement of strategic red cells, platelets and plasma derivative reserves. Clearly we're thinking about this from a regulatory perspective, but there are many considerations as far as maintaining frozen blood, liquid blood, blood still in the veins of donors who are pre-identified as being--you know, potentially could be called on in a given situation. All have pros and cons, and I think worthy of thought.

And then finally we're considering, within FDA, I think a system which that's complimentary to some of the other blood adequacy measures that are in place including the HHS blood inventory measures, which Dr. Nightingale will describe in a few minutes, and the activities of the National Blood Data Resource Center within the AABB and some of the other major blood organizations, but we got a sense during this--particularly during this crisis situation, of needing to know when emergencies shortages were likely to occur at individual transfusion services. Emergency shortages of blood and blood components and emergency shortages of supporting products, be it blood bags or test reagents or other materials.

So we're in the early phase of developing a web-based voluntary reporting system which will allow each of the 5,000 plus transfusion services in the country to report emergency shortages of blood and blood components as far as their own shelves, reagents and supplies. This would be directly to FDA simply to have a grass-roots measure and give individual services a voice to say where they have shortages. Admittedly there will be a certain amount of noise in a system of this size, but with reasonable participation, one should be able to readily identify where a local or regional shortage of a particular product is occurring and be able to address that either through contact with manufacturers or simply serving as an information conduit, or as, going back to the early slides, just by allowing some variations in current policy to make provisions available as needed in time of crisis.

I'll end there. Thank you very much.

[Applause.]

DR. BRECHER: We have time for a few questions. Harvey, Dr. Klein?

DR. KLEIN: I only have two questions. Does the agency have any idea how many of those not-fully-tested units was transfused? And second, is there any way for you to collect and analyze any information about the error rate that may have resulted either from the mass appeal or from the emergently trained individuals, or a combination of the both?

DR. WILLIAMS: Unfortunately, the agency's ability to objectively collect those types of data are currently limited. Any data collection needs to go through the Office of Management and Budget. Potentially this--a case could be made for this type of information collection. It does not currently exist. We do have some anecdotes available. The use of untested units, at least for tests that aren't recommended or required was very minimal, not zero but very minimal. I'm not aware of situations where required or recommended tests were not performed. And in terms of the quality assurance related to use of emergency procedures, again, anecdotal information from just a few sites, but it appears that the QA audits of those materials reflected an unexpectedly high level of unusable units, and the one figure that really struck us was, I think on the order of 24 to 25 percent unusable materials.

DR. KLEIN: I think in terms of blood safety and the likelihood that we will have additional mass appeals, although we hope not like this one, we need to have those kinds of information collected and analyzed.

DR. BRECHER: Dr. Epstein?

DR. EPSTEIN: Yeah. I just want to add a few personal remarks. You know the FDA was very mindful that we were making pivotal decisions about safety and supply and that they were linked. But what was the environment in which the decisions were being made? Well, I think the first and most telling point is that within the first hour or two the reports coming to the agency were that there might be as many as 5 to 10,000 injured survivors on route to hospitals. And contact with the New York Blood Center indicated to us that in that event there was no way that they could supply the need, and there was an urgent need to get blood to New York, as well as an urgent need to assist New York in ramping up collections.

There was also a concern which was widespread that there might be additional attacks, that we didn't know where more blood might be needed next or what kind of attacks might occur. And that contributed to the mindset of, you know, mobilizing donation. Also, as Bob Jones pointed out, the massive presentation of donors happened extraordinarily rapidly, and we were besieged with calls, you know, how can the system absorb all these donors? We can't do it with our existing staff, and we can't do it with fully routine procedures. And I think that there was also the mindset that, well, we'll just freeze the excess, which of course was a naive point of view, because you can only prepare blood and components using well-validated procedures. Otherwise you incur highly significant safety risks.

Now, the situation changed dramatically by the next day. I mean by September the 12th we knew the sad truth, that there was going to be a minimal additional need for transfusion. The concern, however, about additional attacks did not go away, but there was also the inability to turn off the public donation campaigns that got mobilized. We became aware that there were plans at the White House, plans at the Congress. Red Cross had shifted its message, and there was no turning that off. You know those wheels were set in motion. People began talking to responsive organizations, to the Department and so forth, to the blood organizations about maybe this is the wrong message. But the wheels were in motion, and that became a problem in itself.

By the end of the week it became clear that we were going to be living with a period of surging donations, that we simply had to deal with it, like it or not, and that there was now an emerging ongoing acute problem in regard to the availability of reagents and the transport of samples. And that then became the key focus. And then it became clear that we were going to have a persisting problem in that there was disagreement among the major organizations about whether to continue or to cease donation campaigns. And there was at least in some quarters a concept that this was a good time to establish a strategic reserve, that we could capitalize on this mass outpouring of willingness to donate, and I would have to say that that, although a laudable sentiment, was not occurring in the context of a well-orchestrated plan.

And so, you know, I guess what I'm trying to paint is a picture where we were dealing with a lot of pressures and a lot of uncertainties, and trying at the same time to deal with facts on the street as well as diverging sets of projections about what was needed and where we should go. And that the main lesson, at least that I take away from all of this, is that we were not in this crisis working with the benefit of fore knowledge from prior experience. You know, we had knowledge from previous disasters on the limitations to the need for transfusion. We had not, at that point in time, built them into plans.

So these are just some of my own reflections. I mean, I think Alan did an excellent job summarizing what we actually did, but I'm trying to give you a feeling for why it unfolded in that way.

DR. BRECHER: Dr. Chamberland?

DR. CHAMBERLAND: Alan, I wanted to follow up on your response to the previous question, that you said at least anecdotal information that FDA had received suggested that QA audits reflected fairly high rates of unusable units, perhaps in the range of 24, 25 percent. Again, I realize you're basing this on anecdotal reports. Is your sense that that rate of unusable units would be homogenous across collecting sites? Would it perhaps be ranging from--can you perceive that there was a difference in usability from units that were collected in hospitals versus non-hospital settings?

DR. WILLIAMS: As you suggested, all I can get is a seat-of-the-pants feeling. The anecdote that we had was from a collector that had tried using emergency-trained staff as phlebotomists. I think that was really a rather unusual and rare occurrence in that situation, and I think most of the failures from that were related to the phlebotomy procedure. I would suspect for sites that used emergency-trained staff for other procedures unrelated to phlebotomy and donor suitability, the numbers would probably be considerably lower, but we just haven't see the numbers. Perhaps anyone with experience in the area could contribute, but that was the one figure that we had related to phlebotomy.

DR. BRECHER: Although anecdotal, Alan, that may be one of the lessons that comes from this, is to be very wary of using emergency-trained personnel in the actual phlebotomy.

All right. If there are no other questions.

DR. BIANCO: I have one question.

DR. BRECHER: I'm sorry, Celso.

DR. BIANCO: Alan, one common theme, and for which we have heard no data, is that a lot of hospitals with donor rooms collected--that normally will collect just a few directed units--collected a lot of blood, and then had difficulties distributing that blood or actually getting appropriate tests like NAT. What is the authority that FDA--because they are outside our system. There was very good, at least in part, coordination between these--even with the different messages--the organization, the blood and all that. But what is the authority that FDA has to regulate the activities of those hospitals, and how could they become part of the system?

DR. WILLIAMS: Some of our blood and plasma staff are here, so they can correct me if I misspeak, but I think in terms of hospitals that are not registered to collect blood, to do so in any situation is simply illegal. For hospitals that are registered to correct blood, I think probably they're responding to the pressure of people at the door, as you heard, wanting to contribute, and as far as distributing that blood, we allow that in case of need that could be distributed interstate with appropriate labeling. I would surmise that as the relevant authority in those situations.

DR. BRECHER: All right. One last question.

DR. LOPES: Do we know of any of the bioweapons that would pose a problem for transmissibility through the blood supply?

DR. WILLIAMS: The question is do we know what?

DR. LOPES: Are there organisms that might be used as weapons that would pose blood safety problems?

DR. WILLIAMS: Certainly anything that might exist in circulating in the bloodstream during an asymptomatic phase where an individual would be healthy and well enough to donate blood would be a potential blood contaminant, particularly in a bioterrorism attack situation. I think this will be reviewed in considerable depth tomorrow.

DR. BRECHER: Thank you.

DR. PENNER: Just a quick question. I know you're going over different scenarios as to how blood use would go on under certain circumstances. Considering the fact that most surgical procedures around the country could be curtailed in circumstances of great disaster, how much flexibility do we have? Is there enough blood in the system, recognizing that those units then would be available, to handle most of these operations? I'm gathering from Dr. Gilcher's remarks and others that probably there is a lot of blood in the system once it is being held because of the problems of not proceeding with standard procedures.

DR. WILLIAMS: I won't comment on that specifically. I think it's a valuable observation. Certainly one of the first responses in New York was to notify the hospitals to put a hold on not-urgent use of blood, and that certainly made a major impact on available inventory.

DR. PENNER: So on could speculate that there may not be much more than a need for an additional 5 or 10 percent blood in the system under most of the more serious conditions you could consider; is that the thinking?

DR. WILLIAMS: I think it's a reasonable assumption, but still, I think we need to consider--I would think on the far end and consider the worst possible scenario and what you might have to do to meet that need.

DR. BRECHER: Okay. I think we'll move on. Thank you, Alan.

The next speaker will be Dr. Stephen Nightingale, talking about the federal government role in assuring blood safety and availability during a disaster.

DR. NIGHTINGALE: Thank you very much. No slides this morning. There will be slides this afternoon. And the talk this afternoon that I'm giving will be longer than the talk that I'm giving this morning, in part because my topic, which is the federal government role in assuring blood safety and availability during the disaster was one that we received a specific request from the General Accounting Office to comment on in early January of this year, and we determined that we would respond to this request from the GAO, and in fact we ran our responses through our formal clearance process, including our formal legal, our Office of General Counsel.

So what I want to do in this brief presentation is to stick as closely as possible to the responses that we gave to the GAO, which are responses for record, and I think that you will see how they fit into the broader perspective of this meeting as we go along.

The first point that we made to the GAO--and I will reiterate here, although perhaps it need no reiteration here, it needs reiteration in some places--is that in the United States, unlike most other countries, and I am reading here the private sector rather than the government manages the blood supply, and the private sector rather than government is ultimately responsible for maintaining an adequate blood supply. That is not the way it is done everywhere, but that is the way that it is done here, and in this society that has very profound respect for private property and private institutions and for private institutions working in the public good, that is the point of departure for the federal government's perspective on its own role in the management of the blood supply.

During times of peace the primary authority over the blood supply is the authority of the Food and Drug Administration. They have the power to issue and enforce regulations that are intended to ensure that the blood supply is and remains safe in the event of a public health emergency. On the other hand, the Department has additional powers. And what I want to do right now is to enumerate those additional powers.

First of all, under the Federal Emergency Management Act, which is Title 42 of the U.S. Code. I'm carrying it here, but I'm not going to read it today to you in its entirety. But you need to know that the key is that the Assistant Secretary of Health, who will be Dr. Slater, is the federal official responsible for implementing the Emergency Support Function 8, which is the coordination of the health and medical services components of the Federal Response to a Public Health Emergency once it has been declared by the President. Blood and blood products, plasma derivatives, would be components of that services. So if there is a emergency that is declared by the President, at the point where FEMA kicks in, the responsible authority in the federal response is the Assistant Secretary for Health, and blood comes under that responsibility in times of a national emergency declared by the President.

There are three other emergency authorizations. Section 319 of the Public Health Service Act authorizes the Secretary--the Secretary himself, not the Assistant Secretary--to take appropriate action to respond to a public health emergency. These actions can include making grants, entering into contracts, and conducting and supporting investigations into the cause, treatment or prevention of the disease or disorder causing the public health emergency. Blood products and plasma derivatives again come under this rubric.

And the question is why are there two rubrics? I think the key here is money and the official responsible either for authorizing funds or requesting additional funds from the Congress, is at the secretarial rather than the assistant secretarial level, and as I am sure you can appreciate from our experiences, that both have plenty to do in an emergency.

In addition, the Food, Drug and Cosmetic Act gives the FDA authority to issue emergency rules regarding standards for blood and blood products and blood establishments to prevent the transmission of communicable diseases.

And finally, under Section 217 of the Public Health Service Act, during an emergency proclaimed by the President, the President himself has the authority to use the public health service to such an extent and in such manner as would promote the public interest. Again, blood products and plasma derivatives could be subject to the President's actions under these circumstances.

So I have covered times of peace. I've covered times of emergency. There are times in between, of course, that can affect blood, and that is why we developed, in the events surrounding July 1 of 1995, when the Institute of Medicine issued its report on HIV in the blood supply, a procedure in the Department, which has been reiterated, re-authorized by the new administration, whereby urgent matters of blood safety can be brought to the highest levels of the Department, and indeed brought within 24 hours, and that structure is the Public Health Service Blood Safety Committee. That is chaired by the Assistant Secretary of Health. Its members include the Directors of the CDC, NIH, Food and Drug Administration, along with other senior Department management, and that body has in fact met on 24--actually, we scramble on 24 hours notice and continue to do so.

And finally, for what I'll probably call subacute policy matters, we have a variety of structures. One important one is that is not commonly mentioned here is that once a month there is a public health service blood teleconference that Dr. Epstein initiated and has led for many years. This is an extremely valuable way for us to keep ahead rather than to catch up with events that affect people across agencies. Sometimes it seems it goes on for a long time, but mostly we end up at 11 o'clock with still a number of things to say. And that's our baseline structure.

Above that is the meeting that we're holding here today. This Advisory Committee is an opportunity to bring the public, as broad a representation as possible, in to the planning of what again I've called sub-acute, and I think perhaps the response to the events of September 11th can be characterized that way, and of course, the PHS Blood Safety Committee, the senior management, is not restricted to consideration of events that have to be determined tomorrow. That is our senior body.

And one of the lessons that we have learned from the past is that there needs to be method for communicating urgent issues about blood safety and availability to the very top of the Department. We've learned that lesson and that mechanism is intact.

So what I've really described here for you is a framework rather than a road map for the federal government's involvement in assuring blood safety and availability during an emergency. And I think it's important to emphasize that the purpose of the meeting today is to help us flesh out this framework, get it as close to a road map as you can, again with the realization that road maps are only good for about a year or so. Road maps change. If there's one thing that we've learned, and in fact the one piece of information that I was asked, you know, in a sentence, what would you tell Dr. Slater when she came in? And it is to expect the unexpected in this field, something that perhaps needs no emphasis here, but is so--we're looking, I hope here, to turn the framework that I've described into a bit more of a road map.

I think that there is a hope that the road map can also be turned into something of a crystal ball. We've talked about projecting into the future. I am perhaps a little bit more cautious about projection into the future than either the folk here, but I think a very close examination of the past and the immediate past is something that we can--I think we do well and perhaps we can do even better after this meeting.

So I would like to conclude my comments there. I would be glad to answer any questions either now or probably later if we go after another three minutes.

DR. BRECHER: Okay. Do we have any questions or comments? Sounds like there is a government mandate to be involved in this problem, that we have justification. Dr. Penner?

DR. PENNER: Steve, what is the present situation for mobilizing the blood producers and those institutions that are involved with this? Once you've set up this program in the FDA to proceed, what can you do at that point? Can you take over? How do you interact with the various blood institutions that are going to be available? Is there any command situation or centralization? How does it work?

DR. NIGHTINGALE: That is under discussion today. There is, as I said, the framework. We have a framework right now, that you'll see in your handout, the Complete Emergency Support Function 8 is up on the website, fema.gov. There's a command center. There's emergency operations center for FEMA, and requests--there's a mechanism for that to be processed through the government. I think that when you read the ESF 8 or the other Emergency Support Function description is the role of federal emergency support is to supplement existing systems that are damaged or dysfunctional because of the emergency, rather than to replace.

To try to answer your question a second way is that there is a silla [ph] and there is a carib [ph] disk, there is a rock and there is a hard spot here. The rock, I suppose--government or industry--is a Supreme Court -- Nevy v. New York State, which says that the federal government can make just about any regulation that it feels is in the public interest, as long as that regulation is neither arbitrary nor capricious. We can make just about any statute, but you can't pass a statute on September 11th. So we have to think forward about those.

The other is Sawyer v. Youngstown Sheet and Tubing. Now, I didn't go to law school. Right next to you is Mr. Hoots, who is probably reading these right now as I have not. But Sawyer was the decision by the Supreme Court that President Truman exceeded his authority by taking over the blood system. If one had--sailing a course between those gives one a fair amount of latitude, and hopefully that latitude--I perceive that latitude as a good thing because that latitude helps us help the private sector deal with this issue, and I feel in fact quite strongly that our role is to help the private sector do the job, and for the private sector to tell us when and where they need more help, witness this meeting.

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

We're going to move on to Dr. Jeanne Linden talking about the New York State experience.

DR. LINDEN: No, I will not be using slides this morning. For those of you who do not know me, I direct the Blood and Tissue Resources Program in the New York State Health Department, which is a general public health agency, but we do oversee all of the blood banks and transfusion services in the state as part of our responsibility. So we were involved in the events of September 11th, and I'm just going to tell you a little bit about our experience and maybe some lessons that can be learned based on our experience.

It certainly seemed that for us communications were the number one issue or the lack thereof. There were certain things that worked well. There were certain things that did not work well. One thing that worked well is that we had sort of a practice in the Y2K event, in that our State Emergency Management Office already had all of the necessary phone numbers for all of the key people in state government, and in fact, within the first hour after the event, I received a call from the State Emergency Management Office, who knew who I was, asking about the status of the blood supply, which I was able to provide, and giving very early projects about possible casualties, which actually were much higher than they wound up being, and then there were repeated communications after that as more information became available, although certainly, as we know, as time went on, it was clear that the blood supply was really the least of the concerns, and the other issues that we were dealing with from a public health standpoint far overshadowed any blood concerns.

We did have a sense of communications difficulties with the field, however. As Dr. Jones mentioned, we were able to talk to people in New York City as late as about 10 o'clock in the morning, after the first building fell, before the second building fell, but at that point the phones went out and it was not possible to use the regular telephones. E-mail worked for a while. Then that went out as well. We also had problems internally with our e-mail because a lot of our computer capacity was in fact at the World Trade Center and we lost that, and we had to limit our e-mail communications to only absolutely essential communications. So trying to overcome the communications difficulties was one of the biggest challenges that we faced.

We did try to help coordinate the transfer of supplies as needed, although really, ultimately, that clearly was not needed. Upstate as well as other parts of the blood service community in other states were able and poised to send supplies to New York, and in fact, cancel elective surgery upstate as well as in the New York City area.

We also fielded several calls from hospitals seeking permission to collect blood without a permit. Right now there are a little over 40 hospitals in New York that do have a permit to collect blood. All except one of those are in the downstate area. There were some hospitals that had previously held a permit, discontinued their collections and wanted to resume collections, claiming at the time that they still had SOPs and trained staff in place, although that turned out not to be the case. And there were also a number of requests for exceptions to regulatory requirements and established SOPs.

It was clear that a lot of the pressure to collect blood from this overwhelming outpouring of donors came from hospital administration, who really did not understand the situation and the needs. There were blood bank directors who did not want to increase collections, but were basically forced to do so, or who were forced to collect blood without a permit, really against their wishes. The remaining facilities used untrained staff to collect blood. In fact I'm going to tell you later about some of what we found that went on at some of the hospitals. Some used noncompliant history forms that were outdated, and that blood had to be discarded. As other centers have found, shortage of blood bags became an issue. A lot of these hospitals were collecting, instead of 2 or 3 units a day, collecting 200 or 300 on September 11th, September 12th.

We also tried to keep in touch, to the extent possible, as communications allowed, with facilities near ground zero, trying to monitor the need for blood, and also for skin. The tissue was actually much more of an issue with all of the burn patients. Possible shortages of skin were actually a significant concern. We do not usually import skin in New York. We're usually pretty picky about the standards for skin, try and supply it ourselves, and it actually did have to be imported, not for the patients injured at the World Trade Center, but for other patients who were already hospitalized in New York.

We also tried to facilitate communications with the State Emergency Office staff, who were working closely with the military, the police and other emergency agencies, and I must say that the military and the police were absolutely phenomenal. As has been said by other speakers, transportation was not a problem. We had planes coming in, trucks. We were getting supplies in including blood, and that was not a problem. But it was sort of controlled chaos because shipments were coming in and nobody knew what was expected. They didn't know where things went. One lesson to be learned is that if things are going to be sent in, it would be helpful to have it be labeled as to where it was going, because I was getting calls, "You know, we have blood coming in. What do we do with it?"

And another lesson for me would be to make sure that I take home with me my full list of contacts and addresses, because I didn't have that, so I didn't initially know where to send them, and I actually had to go to the Internet and look it up on the New York Blood Center's website to get all of the information.

And there were some communications about where things were going. The New York Blood Center at one point intercepted a delivery that was intended for somebody else. It really didn't matter because everybody had plenty of blood, but things were not really going exactly the way it was supposed to be, so that was a problem in terms of knowing what was coming and knowing where it was supposed to go.

As time went on routine supplies became a problem, but emergency supplies were really not an issue, and that was in fact for all of our public health needs, really not a problem.

We also tried to reinforce communications regarding blood donation. As others have said, the first day it really wasn't clear what the needs were going to be, but by the next day it was very clear that the needs were not going to be great, but we try to facilitate the first day information about available sites, and donor eligibility, all the questions that came up to everybody else. We also gave advice regarding training of volunteers.

By the 12th it was clear that the needs were not going to be great and that it was really necessary to scale back some of the message about blood donation, try to have some of the donors try to come back later. And it was also to scale back some of the emergency measures such as postponing elective surgery, particularly upstate which was not as directly affected as the hospitals downstate. But the communications were not as ideal as they could have been, and there in fact was more conserving of blood than in fact turned out to be necessary, and in fact, some of the hospitals upstate prepared for victims that in fact never arrived.

We also after the fact tallied the usage for the World Trade Center victims. As Dr. Schmidt has mentioned, we found in the range of 224 red cell units were used, 62 unit of FFP, and 12 platelets, totally components of 298, which was a tiny fraction of that that was collected during this time period. The usage was about two-thirds for trauma patients and about one-third for the burn patients, and this was among about 5,000 emergency department visits and a little over 400 hospital admissions by our tally. And I think the reason that this figure differs from the CDC figures, this was all hospitals, this was not only those in the immediate vicinity World Trade Center.

It did seem that lack of a consistent message was a problem later in that week. Some parties were scaling back donations and trying to have donors come back later. Other parties were still encouraging donation, and that seemed to lead to confusion among donors and also the fact that there were continued collections may have been a problem later in terms of the need to discard some of that. The hospitals that did extensive over collecting I think are a real problem in my opinion. For one thing, they ran out of storage space, so we were able to find additional storage space for some of them with assistance of the New York Blood Center. But the rate limiting factor for the collections, particularly for the hospitals, was clearly the testing capacity. A lot of the hospital units just simply couldn't get tested, and we helped to try to address a lot of sufficiency issues, but basically you can't just come up with this out of thin air. And we observed with the hospital collections, unlike the blood center collections, where the pheresis samples could be labeled to be prioritized, the hospital samples were all the same and were not able to be prioritized, and the turnaround time issues with the hospitals in fact led to a discard of thousands of units, as well as shortages of platelets after the first few days, as has been mentioned by other speakers.

Something else that we observed is that these security measures themselves became an impediment to effective care, specifically in the tissue area. We had a problem with corneas. Corneas are shipped in a very specific way and they cannot be inverted. They require special handling. You cannot tip the package upside down, and before September 11th they basically were hand carried by the airlines. With the new security measures in places, the airports basically did not want to deal with this, and we in fact had five corneas that were lost and could not be used because they were not accepted at one of the major airports, so we in fact were successfully able to intervene with the Port Authority Police to make special arrangements for these types of products.

We did also, after the fact, go back and do a poll of the hospitals in New York that collected blood during the week of September 11th, and the results of that are of concern. The number of facilities that used only the routine, trained collection staff was one. Everybody else supplemented with additional staff with on-the-job training to a greater or lesser extent. One facility used nurses and physicians to collect blood but wouldn't allow them to sign the donor forms. So those 10 percent of their units, those could not be used.

One facility located very near the World Trade Center, where they had very much of an outpouring of support, rejected 25 percent of their units due to incomplete donor forms. And based on our tally from these hospitals, that was not the routine, so I don't think it's representative, but it certainly echoes what Dr. Williams said, that this is the order of magnitude that we were talking about of, you know, 10 percent or more of units not being acceptable. Clearly, not to mention the ones where the collection may not quite have been exactly in compliance, but nobody noticed. So in my mind there's certainly question about a lot of the units that were collected and in fact were used, although as I mentioned, since a lot of them couldn't get tested, they weren't used anyway. So that may have evened out in the wash.

We are aware of some mixups in labeling. This is something that we have tallied. I don't have numbers on this, but there were certainly anecdotal reports of people making errors that were in fact detected in the system. Who knows about the ones that were not detected? And of course, since many of these are first-time donors, you're not going to have a historical type on them that you can even check.

So in summary, our experience was in general the facilities were extremely conscientious. They were overwhelmed by the donor support and the concept for blood donation as therapy, not for medical need, but as therapy of people trying to help out. And as we've heard today, I think that's an issue that we really need to look at. The fact that there were mixed messages about whether donations were still needed or not was a problem in my opinion, as well as continued ongoing collections at a very high rate that may not have been in compliance.

Any questions?

MS. LIPTON: Dr. Linden, I actually do have one question, be I know you collect so much good data and it's always--you know, seem to have information that other people don't. One of my concerns, when we talk about incomplete testing, is that perhaps units actually were tested that complied with FDA testing requirements, but were not really transfused according to a standard of care, which now to my mind would mean that you're doing NAT testing for both HIV and HCV. Are you aware of any facility or any hospital in New York that did that?

DR. LINDEN: I'm not aware of any times when NAT testing was not done, mostly because there is a NAT lab that was within close transportation, since it was not the problems that other parts of the country had. However, ALT was an issue because of the sample liability. I don't--people were talking about releasing without ALT. I believe that happened, but I don't have good numbers. That's the only one I'm aware of.

DR. BRECHER: Dr. Gomperts.

DR. GOMPERTS: Thank you, Mr. Chairman.

Dr. Linden, thank you for your presentation and also identifying a number of issues. There are two issues, two gaps, that just listening through this morning, that so far haven't been raised, and I just wanted to ask your opinion on this.

The one is if a second catastrophe or a third catastrophe were to occur at approximately 40 days, 45 days subsequent to September 11th, and perhaps a third one, how would the city, the state respond to that situation?

And my second question and second boy scout scenario that I can foresee, is if there were to be--one of these catastrophes were to be a nuclear episode, where there would be tremendous demand for platelets--and from what I hear there have been some issues around the provision of platelets and the quantity of platelets--how would that be addressed? Thank you.

DR. LINDEN: Well, on your first question, are you referring to the blood being outdated by the time of a second event or just a second event period?

DR. GOMPERTS: Well, clearly, if there were to be a second catastrophe, meeting the supply with a massive outpouring of donors wanting to donate donating, and then of course not becoming available on the basis of the time factor and handling that particular issue for example.

DR. LINDEN: Well, in this particular event, it was recognized very early that the usage was going to be minimal and there were attempts to turn the spigot off, so that in fact I know that the collections in our area continued to be high all the way through September and October, so that the concerns about between day 42 and day 56, there all of a sudden being a tremendous shortage, did not happen. That was staved off because of the collections that were deferred, and I think that's a lesson that we've learned and that we would do well with that in the future, so I don't think that's a concern. But clearly, had there been additional events as we all were afraid of, particularly that first day, that could be a challenge.

DR. GOMPERTS: And the issue around platelets, do you have any data on that?

DR. LINDEN: I do not have total numbers on the platelet losses, but the platelet shortages were indeed a huge problem here, and had there been another event during those days where there were shortages of platelets, we could have had catastrophes, and that I think is a lesson for the future, to think about how we can deal with these platelet issues, prioritizing, testing.

DR. BRECHER: Harvey, last question.

DR. KLEIN: Jeanne, could I ask you, how did you handle the requests for both variations and for collections by unlicensed facilities?

And with the 20, 25 percent unsuitable units that you found, is there any way of knowing what percentage of unsuitable units were actually transfused?

DR. LINDEN: In terms of the requests for variances, the first day we tried to be flexible. We did not grant any facility authority to collect that had not collected before, even though there were some that wanted to, but ones that had only very recently discontinued and assured us that they still had their SOPs and trained staff in place, were allowed to resume, although one of those turned out not to be in compliance and none of their units could be used. We do know that a lot of the facilities conscientiously did a careful review and in fact themselves rejected a lot of the units. How many were transfused that were noncompliant, I don't know. My concern is that it's not zero. I wish I had data on that, but how can you measure--I mean it was chaos. I mean everyone here knows that, to really know whether things were done properly or not after the fact, to determine that, it was really impossible.

DR. BRECHER: I think we're going to have to stop here. Thank you, Dr. Linden.

We're going to move on to the military perspective, Colonel Mike Fitzpatrick.

COL. FITZPATRICK: Before I start I wanted to preface a couple comments. Based on what we've heard this morning, my job as head of the blood program is a privilege, and it's been designed since its inception in 1953 to provide blood outside of the United States to our troops at war. What we face now is the unfortunate circumstance of determining how best to provide blood inside the United States during a period of war. Last time there was a major military conflict with the continental United States was in the Civil War. We haven't really addressed that.

The key elements of our program are that since 1953 and the inception of my office, we have trained professionals to know how to distribute, transport and collect blood products and provide them at the point where they are supposed to be. The key lesson to learn from that experience since 1953 is that nobody's crystal ball is perfect, you can't have the right amount of blood at the right place at the right time, and it will either be too much or too little. Even in current circumstances, I can tell you that we are making choices based on the capabilities we are providing to our folks in Afghanistan, Uzbekistan and Southwest Asia.

So how does that impact on us? I'll go quickly through these first few slides because I want to give you an idea of what our program is set up, and I'll try to concentrate on the last two slides and some comments about comments this morning.

First planning. Everyone's been talking about planning, how do we learn from history? What are the lessons learned? Well, a timeline is very important when it comes to blood. People have thanked the donors for having the blood on the shelf. We have a term in the military called Force Health Protection. That means that in order to be ready to go to war, you have to have your immunizations, you have to know how to don your gas mask, wear your equipment, fire your weapon. We have added into that you need to be a good volunteer blood donor, because if it's not on the shelf when you leave, it won't be there when you need it.

And here's our timeline. C-Day is the day that I would get a call saying blood is needed somewhere. LAD is the latest arrival date or the required delivery date. For our planning factors, given the fact that it takes time to call in donors, takes time to collect the blood, takes time to process the blood, transport it to where you want it to get, should there be a large need for blood, our planning factor says it's going to take us 10 days to get it to where it needs to be. For a limited need, where there are ample quantities available and all we're doing is distributing it, we can do that in two to three days overseas. Certainly we can do much better than that within the continental United States. So just try to keep that timeline in mind as we go through things.

We have positioned ourselves with military donor centers throughout the United States, and for those of you who don't know, we do collect blood of our own within the military and supply almost 100 percent of our own needs. Each of the services has an FDA license and collects FDA-licensed blood, and transports it throughout the world. This is how we're configured. Just for a point of reference, during Desert Shield, Desert Storm there were 83 blood donor centers. Now there are 21.

Key elements here are at Travis Air Force Base California, and at McGuire Air New Jersey, are what's called an Armed Services Whole Blood Processing Laboratory on each coast. They have the ability to pack and make available for shipment 7,200 units of blood a day if needed, and those are our focal points for transportation.

Just a schematic. We have our donor centers. If we exceed the need we would ask the civilian blood collection agencies for blood. All the blood that is collected within the United States for shipment overseas is funneled to one of the ASWBPLs. And we know it's not whole blood anymore; it's packed cells, but nobody will get rid of that name. It just rolls off the tongue too well.

[Laughter.]

COL. FITZPATRICK: Overseas we have blood trans-shipment centers which are kind of mini ASWBPLs. The difference between these two is when the blood at the ASWBPL, it is retested. The ABO and Rh are confirmed, and it's confirmed that what's in the bag is the same as what's on the label, because when it gets out here to the hospitals, it's doubtful that we're going to be doing complete cross-matching. It's doubtful that we're going to have complete testing of the patient, and we want to make sure that if it's given as a type-specific unit, it is correctly labeled. In our history, to our knowledge, we've never had a unit leave the ASWBPL and get to its point of use and be improperly labeled.

A blood supply unit is sort of a mini blood trans-shipment center. They can handle about 3,600 units a day if needed, and distribute the blood to hospitals, forward surgical teams, special operations units, allied forces, if necessary. A blood product depot holds frozen units, and we might address those if there's time, but there probably won't be.

This is our Command and Control Structure, and I'll kind of go over that at the end. Unfortunately I'm at the top.

We'll go through these quickly. We collect blood the way everybody else does. Right now we collect about 110,000 units annually.

This is how we ship it at McGuire. It's stored in walk-in refrigerators, shipped in a styrofoam Collins [ph] box and shipped by U.S. Air Force aircraft. That's one pallet, 120 boxes or 7,200 units of blood ready and available for shipment.

That's a blood trans-shipment center. When it's received on that end every 10th box is checked for temperature to make sure that it did not exceed temperature requirements during transportation, it's checked for the inventory, and either the ice is removed and it's stored in a walk-in refrigerator or it's re-iced and sent forward for further shipment. We have a transportable unit that also encloses frozen blood product. Possibility that could be set up under tents. We have five of those. We can drop it out of airplanes without breaking it, and we've done that successfully.

But here you'll see how we're configured worldwide for our distribution. Not surprisingly, during the Cold War we were focused on Europe and we were focused on the Pacific. We happen to be focused on Southwest Asia right now and there's not much there. But we have responded and we have in place a blood trans-shipment center there. We have in place blood supply units, and we have been able to put together a group to distribute blood throughout a very large geographic area, not because there was a plan that said where everything would go. There was a general plan that said how we would do it, but because for the past 50 years, we have trained people to be professionals and know how to do their job and to be able to think on their feet and put together a distribution system where it's needed.

Even though we're focused on Southwest Asia, I want to let you know that we are still involved in Bosnia and Kosovo and other areas in Europe, and we continue to supply blood there.

This is not the first time we've been involved in terrorist activity. I've had the privilege of being personally involved in four mass casualty situations. The first was the Ramstein Air Show in Germany, where, if you'll recall, three French fighters collided, unfortunately very close to the stands. There were hundreds of casualties, most of them burn patients. There was chaos for the first 24 to 48 hours as they were evacuated to several hospitals. Care was received. Patients were taken care of. Some blood was needed, primarily provided by the Germans, but not excessive amounts.

The next one was the embassy bombings in Kenya. Probably as far as terrorist activity goes, the largest collateral damage prior to the World Trade Center that we're aware of, and the largest number of casualties that actually needed blood that we're aware of. Now, I don't have real good statistics from that area because of the nature of the disaster, but we know we shipped a number of units in, the French shipped a number of units in, the Germans shipped a number of units in, and the reports from the physicians on site were that there were lots of transfusions conducted, because there were hundreds of casualties from the collateral damage of those bombings. I wish I had better data to provide on how many units were actually used and how many patients were actually transfused, but we don't have that.

I put this up to remind folks that even though our experience is that in most disasters very little blood has been required, there is the potential for the requirement for some large numbers of units of blood, but would those numbers exceed what we have on hand in this country? I can say with, I think, relative certainty, no. Okay. We had four planned simultaneous attacks, three of which were successful. If the towers had not crumbled we would have had more casualties. We would have had more blood usage required. Would it have exceeded the capacity of the available blood in this country to respond to it? No, it would not have. Do we have a good system to respond and collect the blood required to support a disaster of that nature and make sure it gets there in time to be used? At this current time I would have to say no, we don't, but we have a large number of dedicated people who do their job, and they responded to the World Trade Center appropriately.

So what happened on September 11th? Well, the Pentagon was attacked, and I get to go by there every day, and it's being rebuilt. And I lost some comrades and some good friends. Our office was staffed with one individual that day because the other two of us were gone, but they responded as they were supposed to, just as everyone else did. Set up an emergency operations center, made the phone calls, made sure that we had an idea of where blood was, where it would need to be moved if it had to be moved, did some things that some people might not be aware of. There is a classified location where the Congress and the President would go to. There is a medical treatment facility there. That has to have blood and it has to be supported.

What is different between the World Trade Center and the Pentagon bombing and Oklahoma, and the "Cole" and the embassy bombings, is that we didn't know if that was the end. And not knowing if that was the end, and not knowing when the next attack was planned or when the next attack would occur, we had to make judgments as to what did we do, how much blood should we collect, how much blood should we get on hand? Should we put into effect the waivers that the FDA put into effect and take on trained personnel and collect more blood. We made the decision not to do that, that we felt there was enough blood within the country to respond to a crisis within the country. We felt there was enough blood within the system to respond to a crisis should a base in Germany be bombed or a base anywhere else or an embassy. So we didn't put into effect any waivers.

We had calls from our facilities wanting us to do emergency transport of specimens to get them tested because they had units that they had collected just like everyone else that they couldn't get immediately tested. Our response back to them was, "What is your need currently for these products? Can you meet your platelet requirement, because right now, rather than devote an emergency aircraft to moving your samples for testing for blood that is probably not needed, we need to use that aircraft for something else that might be needed." So those were the types of decisions being made.

We did do some things I think that were of note. Hawaii was rather isolated. The Blood Bank of Hawaii ships all their testing specimens to Seattle, to Puget Sound for testing. We happen to do our own testing at Tripler Army Medical Center in Hawaii, and as far as platelet requirements, we did testing for Blood Bank of Hawaii, so that there were tested platelets available on the island.

As you've heard from some people, civilian collections exceeded storage. We were asked by some civilian agencies if we could store products for them at our facilities, and we did. We coordinated military air on some requests for blood transport to New York Blood Center without questioning whether that blood was needed or not, and we know that the Air National Guard in the states also coordinated a number of their own shipments of blood, and that there was really not a central organization coordinating that.

So just an example, what we did in about the first 48 hours, the ASWBPL East at McGuire Air Force Base turned out to be conveniently located for New York Blood Center with an easy truck transportation not in the normal air routes that were being used, and we had the facility there that could store 7,200 units of blood if necessary, and train personnel to deal with the blood.

What are we doing now? We've been focusing and hearing about the after action, the impact, lessons learned, a lot of past tense phrases. I would like to remind everyone that there are over 60,000 Americans currently deployed fighting the President's war on terrorism. Those 60,000 individuals are supported by military medical units. Over 17 military medical units are deployed that require blood support. They're in a very austere environment. They're in a somewhat hostile environment, although the risk of casualties is less than it was. But our job is to keep blood on those shelves and available for the occasional soldier that is going to be injured.

In order to do that, we have to determine minimum inventories. We have to manage the inventories. We have to ship and distribute it. We've shipped over 4,800 units of blood to date in support of the operation. We're shipping about 240 units a week in order to handle expirations and inventory. We've established supply routes.

This is a worldwide effort, because if you've been reading the papers you'll note that we're also involved in the Philippines. So those areas in the Pacific are being supported for the potential of a conflict there. I bring this up to point out that it's an ongoing effort. As your collection agencies are struggling to meet current needs, my collection agencies are still meeting current needs and the additional requirement of supporting two operations on two sides of the world. I might need to call on you in the future. I am fully confident that should there be a conflict that breaks out, we will have the same overwhelming response in donors that we had in those weeks after the World Trade Center. I've been asked that before at this Committee. I still remain confident.

During this time we've also instituted the variant CJD deferrals, and we are accommodating those new deferrals.

So just to show you what happened to us after September 11th, we had that same peak. I had general officers calling non-general officers, majors and captains, saying, "You have to have a blood drive right now because everybody else is having blood drives and we want to donate too." We worked our way through that. We've made our own determination. This 9-day supply is just what it--we consider a 9-day supply for our normal routine operations. It doesn't take into account support of Enduring Freedom or the Philippines. And we've pretty well leveled out. We had a little dip, but we seem to be doing okay, although we've had to make some concerted recruitment efforts.

We project what happens at the ASWBPLs and we try to keep these lines level. You'll see these lines going up out here because we're working on changing the shipment quotas, but we have a tool that we use to try to manage our collections and our shipments and make sure that we're not over collecting.

We monitor three areas, the Pacific right now because of the Philippines; Europe because should there be a change in Southwest Asia and something happened that would cause us to go into a different sort of combat environment and we generate a number of casualties, because of the long transportation times involved, the individuals from Central Command or Southwest Asia would go to Europe. We have to have blood in Europe to be able to accommodate those casualties should they occur.

We also have the potential of not being able to provide blood from the United States to Southwest Asia, maybe because of weather, maybe because of an aircraft interdiction or something like that. So Europe serves as a backup supply for Southwest Asia. So they may be a little artificially high. And then of course, Southwest Asia needs to be maintained at a certain level.

So if we put that together and view a national response in the United States, what should we think about? Well, the HHS Federal Response Plan regarding blood management distribution is a little bit meager, one paragraph, three lines, and we probably don't want to go into the specifics of that right now, but that could use some changes.

There is though, within the United States, the Federal Emergency Management Agency and the Office of Emergency Preparedness, whose job is to move things around, respond to disasters, do distribution and do things like that. But blood distribution management is not part of their responsibility. My suggestion would be we take the experts that know about blood, the Red Cross, ABC, possibly DOD, and the AABB, and have a response cell that provides blood management knowledge and expertise to FEMA and OEP. It could be on a regional or national basis. It could identify shortages, and then OEP and FEMA, who work with the logistics people, who move things around, we just tell them where it needs to go and they'll help us get that done.

One of the questions that comes up is dollars. If California needs a bunch of blood and it has to come from Oklahoma and New York and other places, well, who's going to pay for that? Someone will have to eventually, and that will get sorted out in the water as we are sorting out things now, but it would be nice to know that in advance if we could. So I think that's one national response role.

The other one is safety, and I want to touch on--Dr. Klein mentioned at the AABB--and I was fortunate enough to share a podium with him one night--and brought up a number of concerns that have been discussed here, but not necessarily as importantly as they might need to be. That outpouring of blood, those emergency collections, those staffs that were overworked and over stressed, made mistakes. That's apparent from what Dr. Klein's provided, from what Dr. Linden's provided. Shouldn't our job be to try to provide an environment that doesn't force them into that situation, that allows them to collect blood under GMP practices, test it under GMP practices, and provide to the patients the safe product that they expect? Is there a possible alternative therapeutic mode that we can provide to donors other than donating blood? I'm not a behavioral scientist. I don't know what that might be. I think Dr. Gilcher's method of taking samples, pretesting and taking their names, might accomplish the same thing. I don't know that for sure, but it's certainly worthwhile to look into.

We need to realize that in the cases of terrorist attacks, bombings, that history shows us that in only rare instances are there large numbers of mass casualties that require blood, and that if we don't find those casualties within the first few hours, they then become fatalities, and the blood need is reduced by the length of time it takes to find the casualty and get them to a facility. That's unfortunate, but it's true, and it's something we need to face.

Did we miss an opportunity? We had a time period when we had the focus at the highest level of government and civilian agencies on blood collection, blood recruitment, the need for blood. 70 senators and representatives, everyone demanding, wanting to donate to help out and feel better. But as an industry we weren't able to get our act going and provide them the appropriate message, which was that there is enough blood now, we don't know if there will be enough blood next week, the week after, two months from now, and we need your help in getting that message across to the public, and I think we missed an opportunity there.

Was there really an acute problem with the availability of reagents? To me you define an acute problem because there's a need. There's a need to test blood and put it on the shelf if there's a requirement for the blood. There was ample blood tested, available and labeled on September 15th to meet the need. Now, on the 12th, 13th and 14th, there was a lot of unsurety, but there was still probably ample blood available. How do we define an acute need? What is the emergency? I think we need to address that.

I want to close with just one other comment. Since the advent of blood banking which has been providing blood to combat, which has been a military role for a number of years, and advances in blood banking has been a military role for a number of years, really since the Spanish-American War, when the first mobile blood bank began, we still--I can still only provide the same product to the forward surgical team that was given then, red blood cells or fresh whole blood. I can't provide platelets. I can't provide plasma. I can't improve the care of that patient from what was done during the Spanish-American War. We can get it there faster. It's better tested. It's safer. Shouldn't we be focusing on treatment modalities that could improve patient care, not only for my patients, but for our patients from the World Trade Center or any other disaster? Shouldn't we be focusing on improving hemostasis, which we are doing through the advent of some bandages that are improved, but we need to work faster on them. Can we focus HHS and support in funding on improving those things? Is there an oxygen solution that has a longer dating period than 42 days, that can be used to provide a better response valve than frozen blood? Frozen blood is the best thing we have now, but it's fraught with its own problems.

So I'd like us to take into consideration, when we look at a federal response plan, the need to be able to distribute what is probably an adequate inventory within the country, quickly and efficiently to the site that it needs to be gotten to.

DR. BRECHER: All right. Mike, I think we need to move on.

COL. FITZPATRICK: Okay. And I'd like us to look at the alternative therapy, and if we can improve patient care at those sites. Thanks.

[Applause.]

DR. BRECHER: Thank you. We're running a little behind. Our last speaker of the morning is Dr. Gabasto, talking about the international perspective on disasters and blood supply.

DR. GABASTO: Good morning. My name is Jean Marc Gabasto. I'm adviser on public health laboratory services in the Pan American Health Organization. I'm going to replace Dr. Jose Ramero Cruz, who is in charge of the Blood Bank and Laboratory Service programs in the same organization, but at the moment he's in Bolivia.

I would like to thank the organization for this event and in particular to Stephen Nightingale for the kind invitation. And apologize for my very bad English and this accent, but it's not my fault. I'm from France.

[Laughter.]

DR. GABASTO: But I can try to present you in a short conference the last publication we have elaborated in the Pan American Health Organization. It's a guideline on the organization of laboratories and blood bank in disaster situation. It's in Spanish version, but we hope have the same publication in English in a few weeks. So that guidelines was elaborated by two programs, the program on disaster of the Pan American Health Organization and the program on essential drugs and technology. Laboratory and blood bank are included in the second.

First slide is the contents of the guideline. In the introduction we have the impact of disasters and consequence in the public health sector after we studied the appropriateness and mitigation for public health and clinical laboratories and blood banks and organization of health services in response to natural disasters. I'm speaking about natural disasters and not like the last presentation, human disasters.

Recent disasters in Central America, such as George and Mitch in 1998 and the Salvador earthquake to South San Juan, called attention to the need for integrating public health laboratories, clinical laboratories and blood banks with health sectors emergency plans in three priority areas. First, the diagnostic confirmation of communicable disease with very high mortality rates. Second, the availability of basic tests used in carrying the injured, and the timely provision of safe blood.

The following factors influence the emergence of communicable disease. Change in population density, displacement of population, exposure to the elements influence the emergence of acute respiratory infection for example. Change in the ecological balance that facilitates the proliferation of vectors, dengue and malaria. Displacement of animals which forces development of (?) like rabies and plague. Disruption and contamination of the water supply, water and food-borne disease, reduction in the response capacity of the health services network due to damage to the health services infrastructure or to increased demand like of safe blood, and disorganization of public health programs in general.

What does it propose? The impact of disasters on infrastructure and the health services will be specific emergency measures to ensure basic services to care for affected population, and to establish a surveyal system. In order to guarantee the effectiveness of the intervention during that critical period, it's necessary to reduce the variability of laboratories and blood banks, mitigate effects and improve efficiency.

Objectives. First to sensitize and orient health workers, authorities, directors of laboratories and blood bank, et cetera, of identifying the responsibilities and functions of the services and disasters made on priorities, needs, and the local capacity for immediate response.

Second, incorporate international emergency plan activities to mitigate and reduce vulnerability and to restore and reorganize the health services.

The specific objectives: ensuring communicable and clinical diagnosis, public health laboratories and clinical laboratories, and providing safe blood, blood banks.

First chapter, Preparedness and Mitigation. Common for both public health and blood bank services, though not a subject today.

So the next is Blood Bank Organization. The National Blood Commission or Council as the main actor to providing intervention guidelines in the countries. Three stages: preparedness, emergency stage and post emergency. At national level establishing a national reference blood bank to coordinate operation and designate centers that are strategically located in accordance with your political condition, access route and communication facilities. Provide an alternative center in the same country in case of destruction of the first one or collapse. Maintain an inventory of human health services. Organize a communication system. Organizing the information flow, organizing the transportation of blood components, using other way like drug transportation or vaccine transportation, so-called chain, it's a thing called chain. Define the mechanism to receive, test and transfuse in disaster area, planning the blood collection in accordance with needs, and organizing simulation exercise in the network.

At each blood bank level, defining and establish donor reception and orientation, screening tests, blood grouping, component separation, produced for transfusion, shipment of blood and components, and uninterrupted support.

Second part, emergency stage. Assessing the needs for blood locally and immediately. Confirm the number of units available for immediate release. Evaluating the processed you need. Evaluating the ability to meet the demand before addressing the community. Concentrate volunteer donation centers in areas not congested by the disaster. Collect blood in accordance with the national standards. Easily accept people who have previously donated blood. And mobilizing skilled health workers who are trained.

Post-emergency stage. Assess compliance with the existing emergency. Implement appropriate corrective action. Evaluating the coverage of the demand. Replacing the stocks. Checking the inventory and use of supplies. Report on (?) action to the authorities. Report to and thank the community.

Thank you very much. So I repeat this English version will be ready in a few weeks. Thank you.

[Applause.]

DR. BRECHER: Thank you. We're going to adjourn for lunch. We will start again promptly at 1 o'clock.

DR. NIGHTINGALE: If anyone wishes to speak in the public comment session this afternoon, just let me know if you could. You can speak today and you can also speak tomorrow in the public session, though hopefully not on the same topic or at least with the identical words.

DR. BRECHER: Just one other comment. The industry perspective that will be presented, our number of speakers has ballooned, and so I'm going to give everyone a heads-up. You're going to probably have about 5 minutes, each, so make it pithy.

[Whereupon, at 12:15 p.m. there was a luncheon recess.]

A F T E R N O O N S E S S I O N

(1:08 p.m.)

DR. BRECHER: Would everyone please take their seats?

All right. In the interest of time, I think we'd better get started. We'll start with Karen Lipton from the AABB. So, Karen.

MS. LIPTON: Thanks very much. Steve had actually originally placed me on the agenda to give a statement on behalf of AABB, and he really had asked me to focus on the AABB's response in the hours and the days and the weeks following September 11th. Our story isn't very different though from the other organizations, and so I asked Steve if we could give what I would call a more prospective look at some of the issues.

Before I turn over the podium though to talk about some of our prospective efforts, I want to set the stage by showing three slides of data that's been collected by the National Blood Data Resource Center which is a subsidiary of the AABB. The Data Center of course has its own board, it has its own medical and technical advisors. But they've been involved in collecting data both from blood centers and some hospitals for probably the past 24 months.

I just want to show you up here in this first slide, it really shows us total U.S. collections of whole blood and red cell units from January to December 2001. Now, this is based on a sample of 26 blood centers. It says 25 because I think midstream another joined. But it's a sample of the 26 blood centers that represent different geography, different size and different affiliations. And then it's a statistical weighting of the sample for the other nonreporting centers.

And what it really shows you is that in September and October and November, we collected a total of 572,000 red cells and whole blood units in excess of our predicted levels, which is really a phenomenal amount for all of us.

If you look at the biweekly inventory, it really does track just behind the curve, and shows that our inventory levels were fairly steep them in October and November and then came down. The dotted line you see is for 2000, and we actually had collected data for 2000, and I just wanted to show you in comparison what happened to inventories, which is not surprising, it really is reinforcing everything else we've heard this morning.

And finally I want to show you this last slide which is the whole and red cell units that are outdated. I want to talk a little bit about the definition of "outdate." For purposes of the study and what was told to the participating centers, we defined "outdate" as blood that outdates on the shelf of a blood center. That being said, I can tell you that some blood centers actually do things a little bit differently, so it's very, very hard to tell whether this is an actual blood center outdate. The other thing that happens is that this does not account for any of the blood that outdated on the hospital shelves, and we really don't know whether during this time period, when we had such a bolus of supply going through, whether there actually were more outdates. And I think Steve is going to show us some data later that suggests that perhaps there was more outdating on the hospital shelves.

If you see the line below, you can see that last year's outdates were running fairly steadily all the way through. That's the dotted line. And what you can see again on the outdates related to September, October and November, is that they were about 4.7 times greater than the prior month's average, which is a pretty significant amount.

Now, again, before I turn the podium over to Don Doddridge, I do want to talk a little bit about the Inter-organizational Task Force. Shortly after September 11th we actually had the--it was a very fortuitous experience to have the AABB meeting in San Antonio, and at the meeting there was a lot of discussion about some of the issues that had happened, and how we could do a better job in the future. And our board at that time, then chaired by Dr. Harvey Klein who's a member of this Committee, decided that they would try to create an inter-organizational task force composed of all the people that we thought should be sitting at the table to look at how we could do a better job. It took us a while to get the group going. There's nothing quite like seeing an agenda like this to suddenly have everyone's calendars cleared and be able to actually have a face-to-face meeting, and indeed that's what happened to us.

And Don Doddridge very graciously agreed to take over this task, and he is now going to report out the report and recommendations of that task force. Don.

MR. DODDRIDGE: Thank you, Karen.

Good afternoon. I am Don Doddridge, the Chief Operating Officer of Florida Blood Services, and today I am representing the American Association of Blood Banks Inter-organizational Task Force on Domestic Disasters and Acts of Terrorism.

Following the events of September 11th, 2001 the blood community recognized the need to evaluate actions taken by the blood community in response to the tragedy, to examine lessons learned, and to develop recommendations relating to the blood community's response to future domestic disasters and acts of terrorism.

Last December the American Association of Blood Banks convened an inter-organizational task force representing the stakeholder organizations and the blood banking and transfusion community. Participants in the task force included representatives of the blood organizations, government departments and agencies and the vendor community.

Although the mission of the task force is simply stated, fulfilling the mission was quite an undertaking. I am very pleased to report though that every organization worked towards this common purpose. As Chair I am here today to share with you the preliminary findings and recommendations of the task force.

The most significant findings of the task force were there are no currently identified scenarios in which the medical need for blood in a domestic disaster would be beyond the capacity of the blood organizations to respond. I think you've heard that over and over in some of the presentations this morning. Now, there may be some out there that we have not had to deal with yet, but currently we feel like the local needs can be met. We consulted with medical and military experts who could not identify a scenario in which there would a significant number of casualties or survivors that would require immediate blood transfusion. We know that the blood collection community has the capacity to increase collections three-fold in the short run if that is required. We will continue to evaluate whether there are any other scenarios such as a civil disturbance which might suggest a different conclusion.

The single greatest risk to the blood supply is a disruption to the system. That would include donor deferrals related to exposure to biological agents, vaccines, unavailability of blood collection supplies, and transportation problems.

You have already heard a number of presentations on collections, inventories and outdates relating to the months following September 11th. Although we might not all understand or agree on the actual amount of collection in excess of medical need, every blood organization agrees that collection that is greatly in excess of medical need, is not productive because it stresses the system in some very unhealthy ways.

Following September 11th over collection resulted unnecessary discard of untransfused units. We also had increased error rates in the collection process which has already been discussed. There were some serious financial losses in the blood community. Donor confusion and disenchantment relating to a lack of a clear public message was something that we're still dealing with.

New shortages in the months following the period of over collection. I think you've seen from some of the data that Karen just showed you, that collections are going downwards.

The potential transfusion of units collected under emergency conditions after those conditions had ceased. The primary purpose of this report, however, is not to delve into the problems encountered after September 11th, but to use these issues to create a responsive and efficient system for the future.

The actual task force recommendations are as follows. One of the first recommendations is the medical need for blood should be the driving force for all subsequent actions. The local blood center or centers, which we define as the centers most proximate to the disaster, should have the primary responsibility for ascertaining the actual medical need. We want to establish real-time connections with the hospitals involved to attain estimates of anticipated casualties and establish a communication with the local disaster control teams. We would strongly encourage our blood collection facilities to establish communications with the local FEMA office.

The task force also concluded that the medical need should be established by using predetermined formulas for blood needs relating to the specific type of casualties, and we have created a work group to come up with these formulas.

The second recommendation is that the blood community should avoid creating supply excess at the local blood center. Unless specifically requested, the local blood center should not initially receive from outside sources a quantity that is more than the average daily distribution of that center. Further, outside source requirements should be determined by medical need, which should be updated as needed at a minimum of every 12 to 24 hours. The blood community should develop messages for educating and informing the media and the public that most disasters do not generate a need for a massive amount of blood, and to develop alternative roles for the public and potentially medical volunteers, and some of our centers have already done that.

Having worked in the blood banking field for over 30 years in Florida, I have experienced many natural disasters as a result of hurricanes, including a tropical storm which we had four days after the tragedy of 9-11. The reality in all of these is that there was no immediate increased need for blood. The need for blood came days and weeks after that when we had collections our mobile units were not able to go out and collect, and created a regional shortage of blood that appeared within say days or weeks after the actual disaster.

The task force should take steps to ensure that other stakeholders are consulted in the development of a national disaster plan for blood needs. The activities related to blood should be explicitly incorporated into the FEMA Federal Disaster Plan as well as the American Association of Hospitals and the JACO [ph] Disaster Plans. Blood facilities should be recognized by local, state and federal authorities as health care agencies, and they should be treated as a component of any emergency organization network. This designation will enable blood collection facilities to obtain critical services and materials, such as electrical power and the right to transport materials in the event of emergency.

The blood community should establish clear defined lines of communication to facilitate the blood community's response to domestic disasters and acts of terrorism. The task force felt strongly that there should be a single agency within HHS, preferably the FDA, designated as a contact point for government contact for blood activities. Communication networks with redundant alternate capabilities and focal points should be established. I think we heard that clearly from the New York experience. One means of communication is not going to be something that will take care of all different types of disasters. If one medium doesn't work, you need to have another media out there.

The transportation mechanisms for blood, test samples, supplies, and reagents including alternate and redundant capabilities should be identified and communicated in advance of the next disaster. The grounding of almost all commercial aviation, as well as difficulties experienced by the military in transporting blood for civilians, made us realize how critically important it is to have transportation issues resolved before the disaster hits.

A few of our organizations, including mine, were tapped into the Angel Air flights and others, with flights flown by the Civil Air Patrol with pre-approved clearance to operate in case of emergencies. Angel flights allowed us to serve as a depot to coordinate anticipated shipments to blood to New York. Secondly, since we are also a large regional testing lab for many blood centers up and down the East Coast from New Jersey to Puerto Rico, we were able to arrange transportation on those Angel flights to bring those test samples down to Florida Blood Services for testing.

As it turns out, both the capability and means were there, but not all knew where to find it immediately. We need a plan to assess the collection, processing and testing supply needs, and we need to integrate that plan into the Blood Disaster Plan.

The task force concluded that the suppliers were in the best position to assess those needs, and you're going to hear from them a little bit later. We also concluded that "just in time" inventory management may not be compatible with planning for future crises, particularly if those supplies come from offshore facilities. The task force will investigate the advisability of participating in the CDC National Pharmaceutical Stockpile program. This is a program that ensures the availability and rapid deployment of life-saving pharmaceuticals and medical materials.

Any revisions, interim or permanent, to existing regulatory requirements relating to donor suitability, collection, testing and release of supplies and reagents should be based on actual medical need. Implementation of emergency procedures generates concern about the safety of the blood collected under such circumstances, particularly for units collected under emergency conditions, but transfused long after the emergency is over. FDA already has a mechanism in place for prioritizing release of test kits and reagents and we'll be working closely with that.

In conclusion the AABB has agreed to serve as the coordinating entity for the blood community during times of national disaster and in response to acts of terrorism within the United States. In the event of a disaster the AABB will immediately convene the blood banking organizations and contact their local blood center to evaluate the medical need and assess local supplies. The task force will consider short, medium and long-term needs. The task force will coordinate obtaining information about excess supply and determine need and logistics of shipping excess supply and communicate that information to the blood banking community.

The task force blood banking organization will convene at regular intervals, reevaluate medical need and estimated blood requirements as needed at least every 12 to 24 hours, and will communicate that information to the blood community. The task force will also invite additional constituents to participate in the task force deliberations as needed.

I think this is one of the most important messages we want to get out of this. The single biggest determinant of a successful response to domestic disasters and acts of terrorism is the blood already on the shelf. And I think you've heard that from several speakers this morning. The task force recognizes that the provision of blood and response to disaster requires an inadequate supply of blood be available throughout the country on a daily basis. It is the blood that is on the shelf the day of the disaster that is most critical. It is the chronic shortage of blood that is the major concern, not the possibility of needing to respond to an increased medical need. Blood centers should have a 7-day supply of blood on hand at all times. However, this is not currently the case, and we must continue to educate the public and the media that blood is needed at all times, not just in times of disaster.

In closing I would like to quote Dr. Arthur Kaplan, a past chairman of the Federal Panel on the Blood Supply, who stated, "These patchwork solutions don't suffice. We need to have a sustained national crisis mode response to increase donations. It's not enough to simply say we're going to work on it." Thank you.

[Applause.]

DR. BRECHER: Thank you, John.

We're going to move on to our next speaker, Lisa Marie Brody from the America's Blood Centers.

MS. BRODY: I will try to keep this to 5 minutes.

America's Blood Centers' members have a tremendous amount of experience dealing with a variety of emergency situations. Our members are located virtually all across the United States in every geographical area. So they have planned for and experienced every natural disaster situation, including hurricanes, earthquakes, and most recently providing blood to the Houston floods.

Our experience also includes primary responsibility for providing blood in response to many of the recent tragedies, including September 11th, the Oklahoma City bombing, and Columbine.

America's Blood Centers' members collect approximately 7 million blood donation units each year, which represents about half the blood supply. Our members are located in 45 of the 50 states and operate approximately 450 blood donation sites.

Because ABC members are community based, emergency management activities are a large part of our responsibility to the communities and hospitals that we serve. To that end, our members work with a variety of--on a number of levels and with a variety of agencies that serve functions in emergency management, like hospitals, county offices of emergency management, and the state offices of emergency management, which are the state and county FEMA offices.

With any emergency situation each group uses their individual expertise to determine a course of action, and for America's Blood Centers September 11th tested our expertise and resources. First among the actions taken by ABC members was to determine medical need. This determination was done on September 11th by contacting our member, New York Blood Center, about the possible number of injuries of people located in the World Trade Centers. Vital to the management of the blood supply during an emergency is communication and coordination among the blood centers. By communicating the medical needs of those injured, our blood centers were better prepared to gauge their own needs versus what they were able to supply to New York Blood Center.

Also by communicating and coordinating with our other blood centers, our blood centers were able to know what to tell their stakeholders including those donors who spontaneously lined up around the block to give blood. Also by coordinating information we can also save the blood--we saved our blood centers directly from--hopefully saved New York Blood Center the problem of having to answer questions about whether or not they wanted blood from other organizations.

Next ABC transported blood to the affected area, in this case which was New York Blood Center, using overnight carriers and our own member center transport vehicles.

Finally ABC members coordinated with hospitals and county and state offices of emergency preparedness to prepare for emergencies like these with testing drills.

ABC members were confronted with a number of problems on September 11th. First among those was transportation problems. The terrorist attacks shut down air traffic, and roads and bridges had closed. Fortunately, our members were able to get around that by renting trucks, using the National Guard and voluntary organizations cleared to fly into disasters, such as the Angel Flights organization.

During times of national emergency communication is critical. September 11th was an extreme example of just how critical communication is. Cellular phones were--and land-line phones were jammed within an hour of the attack. Soon after the second World Trade Center tower fell, our e-mail was completely lost with New York Blood Center. Fortunately, communication remained partially opened with New York Blood Center through their New Jersey division. And we also got around the communication problem by using ham radio operators.

The third problem that we encountered was that of supplies. Because most manufacturers and some blood centers operate on a "just in time" inventory, many of the manufacturers were unprepared to fill the requests from blood centers for additional testing equipment and blood bags due to the influx of donors.

Finally, America's Blood Centers' members experienced a lack of coordination from county and state offices of emergency preparedness with the FEMA national office. Some of our centers were simply told that no transportation was available. When we communicated our needs to the FEMA national office, they seemed unaware and unable to assist us. In addition, there seemed to be an assumption that the American Red Cross was taking care of the blood-related patient needs, which wasn't the case with September 11th, because New York Blood Center, who was providing most of the blood to the New York area, is our member.

There are three levels of participants in emergency management for blood services. First are operational organizations which are represented by the American Red Cross and America's Blood Centers. Second, you have your professional organizations, which is the American Association of Blood Banks and the College of American Pathologists. Finally, you have your government organizations, which is the Advisory Committee on Blood Safety and Availability, FEMA, the Office of Emergency Preparedness, and the National Guard.

The following list that I'm going to be going through represents the support initiatives that blood centers need to properly prepare for and act in an emergency situation. First the Advisory Committee--excuse me one second.

Operational organizations. As I mentioned previously, operational organizations have to determine medical need in order to maintain the supply for the hospitals they serve and to manage the overwhelming influx of donors expected during a major disaster; establish communication and coordination plans; develop transportation methods, taking into account each disaster type; and coordinate emergency procedures with the hospitals they serve. In addition, they should also coordinate emergency supplies with manufacturers.

We look to our professional organizations to provide expertise. For example, most recently you probably heard about irradiation of mail. And so we would look to our professional organization to provide expertise about how to manage shipment of blood and any irradiation problems that might occur.

Second, we would look to our professional organizations to develop medical needs models, as discussed by Don Doddridge earlier; models for various emergency situations.

Finally, we would like our professional organizations to work with the advisory committee and government agencies to secure communication and transportation alternatives when there might not be any available.

This is the list. The following list represents the support initiatives that blood centers need to properly prepare for and act in an emergency situation. First, the advisory committee should encourage FEMA and CDC to include ABC in support function activities, including coordination of ABC participation in the planning for massive evacuations, field hospitals, etcetera.

Second, along with the blood banking community, the advisory committee should support transportation and communication plans developed by blood centers for emergency situations, and make sure that we have permission and, most importantly, funding from the government and military authorities to do what we need to do.

Next, facilitate the regulatory release of needed products; as for instance, the FDA lot release required by FDA regulations.

Next, for government agencies to address the potential effects of measures against bioterrorism on safety and availability of blood and blood products, the effects of irradiation on mail and parcels, donor referral issues, and indeterminate screening test results related to massive vaccinations.

Next, study the chemical and biological agents that may increase the need for support with blood transfusions and bone marrow transplants, such as chemicals that produce blood disgratia.

Also, that the advisory committee, FDA, and CDC, with help from blood organizations, should develop guidelines and/or requirements for emergency communications for blood services on a county and state and national level. This should include plans for dealing with the influx of donors. We don't need blood organizations saying different things. For instance, the blood organizations together may want to give the Secretary the authority to call off the donors if there is a huge influx of donors and there is not really a medical need for extra blood.

And finally, that the advisory committee should encourage HHS to fund PSAs calling for blood donation, or no need for immediate blood donations.

It's important to mention that ABC is participating with the American Association of Blood Banks Inter-Organizational Taskforce. So the presentation that I just gave is really the perspective of ABC donors. And we're looking to AABB to incorporate some of our needs into their goals. That's it.

[Applause]

DR. BRECHER: Thank you, Lisa.

The next speaker is Dr. Jerry Squires, American Red Cross.

DR. SQUIRES: Mr. Chairman, members of the advisory committee, prior to September 11th, the need to develop a stable and sustainable blood supply to meet the increasing patient needs was really already apparent. In order to accomplish this goal, it's really imperative that the entire blood industry and the American public recognize this growing need for blood donations that really help save millions of lives each year, and also prepare us in the eventuality of another disaster, another set of emergencies.

To encourage an industry-wide response to this need, we are currently participating with the Inter-Organizational Taskforce on Disaster Planning and Bioterrorism. We really look forward to continuing that dialogue, the dialogue that has occurred already, with the taskforce, in the hopes of achieving a consensus on the roles and responsibilities of the blood banking community in responding to future threats and natural disasters.

Let me spend just a couple of minutes talking about blood collections prior to September 11th. Prior to the attacks on September 11th, the Red Cross had implemented a summer donor recruitment campaign, which had contributed to increasing donors presenting at Red Cross to about 7.5 million in fiscal year 2001, as compared to fiscal year 2000. That's a 6.1 percent increase in presenting donors.

In actuality, this represented about 543,000 more units of blood donated in fiscal year 2001. These increased collections had a direct impact on our inventory. Our total red cell inventory was about 33 percent higher this past August, as compared to the year before. And our Type "O" inventory was about 83 percent higher over the previous August.

We had also begun implementation of a strategic blood reserve. And this effort was directed at ensuring a readily deployable liquid inventory, a cadre of dedicated blood donors who would be available in times of need, as well as a frozen reserve.

Now, let's turn to the situation immediately after September 11th. After September 11th, as we've all heard over and over and actually experienced, there was a tremendous outpouring of support by Americans wishing to give blood in response to the attacks on our country. It's important to remember the uncertainty that followed these attacks. There were statements from our nation's leaders for really several weeks following the attacks, that the country needed to remain at a high state of alert, and that it was unknown if or when there would be future attacks.

This sense of uncertainty among our nation's leaders was really evidenced by the fact that the Red Cross was called upon to perform blood drives at several executive and legislative offices. In fact, during the week of September 11th, the Red Cross collected over 275,000 units of blood.

These collections progressively decreased over the next month, to about 130,000 to 140,000 units of blood per week; which represents the approximate weekly goal for the Red Cross. And they've remained fairly constant since that time.

On the other hand, distributions to hospitals have continued to increase, leading us yet again to augment our needs or our efforts to further bring in more blood donors. For this reason, again, it's essential that the public understands that blood is a perishable commodity, and it must be regularly replaced, just as we constantly replenish the nation's stockpile of vaccines, drugs, and food.

In regard to our strategic reserve, we were able to greatly improve upon the three-day inventory that has traditionally been found in the blood industry--a perilously low level, that obviously contributes to ongoing or periodic shortages throughout the country. We have dedicated units to a frozen reserve of blood, to meet unknown contingencies. And we have also begun to aggressively outreach to those donors who donated around September 11th, to come back and donate yet again.

With regard to our current efforts to ensure a stable and sustainable blood supply, we need--the Red Cross needs to collect about 25,000 units of blood in order to maintain our inventory of blood. And to that end, we are beginning today implementing an aggressive $1.5 million advertising and direct marketing campaign, to continue to build and maintain the blood donations, maintaining that level of inventory to meet ongoing patient need.

Let me turn in the last few minutes here to some issues that the Red Cross believes need to be addressed. Immediately after September 11th, the Red Cross was able to mobilize our national network by moving about 5,000 units of blood to the two Red Cross blood centers closest to New York City and Washington, D.C. However, we did experience a number of logistical issues that will need to be addressed if the blood industry is to respond in a timely manner to future attacks or natural disasters.

First among these is transportation. As everyone is well aware, the transportation infrastructure of our country was severely disrupted. And as a result of the grounding of air transportation following the attacks, we faced a number of challenges, if you will, in transporting blood samples to our national testing laboratories, and difficulty in actually transmitting or transporting units around our system.

Secondly, spontaneous volunteers, if you will: As our citizens are well known to do, Americans came out to volunteer their services in that time of national need following the attacks. Our blood centers were literally inundated with nurses, doctors, other health care practitioners, asking how they could help.

This outpouring of support was difficult to manage because of the really limited role that health care professionals can play in our regulated environment. The blood banking community will need to work on programs to seamlessly incorporate these volunteers, so that we can utilize their expertise and their compassion.

Thirdly, supplies: For the most part, the Red Cross was able to obtain the needed supplies to handle the huge increase in donations. However, for future events, the blood industry will need to enhance supply channels to meet unanticipated demand and ensure good supply chain management structure. And we'll need input from the suppliers, particularly in this regard.

Fourth, increased collections: The Red Cross experienced an outpouring of support from the American public wanting to donate blood following the September 11th attacks. As a result, we really had to ramp up every facet of our operation, to ensure regulatory compliance and a seamless system that ensured that donations could be made and that those donations could be made with the safety and compliance and quality standards that we need to maintain.

In fact, the Red Cross saw no change in our rate of reportable errors in the days after September 11th. We were also able to freeze about 10,000 Group "O" red cell units from these generous donors. It will be important that blood banks have contingency plans in place for future natural disasters, so that we are able to handle this kind of potential increase in donations.

And finally, let me just return to a few comments on the Federal Response Plan. The American Red Cross, as many of you know, plays a vital role in the nation's response to disasters. We are the lead agency under the Federal Response Plan for emergency support function number six, mass care. We're the only non-government agency with lead responsibilities.

We are also a primary support agency for ESF-8, health and medical services, where we are tasked to provide blood and blood products. It is important to note, though, that Red Cross responsibilities under ESF-8 go well beyond the provision of blood and blood products. It includes such items as the provision of emergency first aid; supportive counseling; health care for minor illnesses and injuries to disaster victims; assisting community health personnel; providing supportive counseling for family members of the dead or the injured; providing personnel to assist in temporary infirmaries, immunization clinics, morgues, hospitals, nursing homes; acquainting families with available health resources and services; and making appropriate referrals; and providing coordination on casualty and patient information.

Given this extensive role under ESF-8, the Red Cross will continue to support HHS and others through our responsibilities outlined in the Federal Response Plan. However, a national strategy on blood products and its role in disaster preparedness will need to be the coordinated effort of the entire blood banking community. And the Red Cross looks forward to continuing a dialogue with the AABB and ABC in moving this process forward.

In conclusion, on behalf of the Red Cross, I want to thank you for the opportunity to provide our insight into the events following September 11th. And once again, it is imperative for our national preparedness and the daily treatment of those with life-threatening conditions that Americans continue to donate generously. This act can, and does, save lives.

[Applause]

DR. BRECHER: Thank you, Jerry.

Our next speaker will be Dr. Ed Snyder, from Yale University.

DR. SNYDER: Thank you very much, Mr. Chairman. It's a pleasure to be here to represent Yale New Haven Hospital, and give you some insight into what happens at a hospital. Most of the morning has been spent talking about people providing blood to hospitals, and I wanted to give you just an idea of what we've done at Yale.

What we decided--Well, let me tell you a little bit about the university first. Oh, conflict of interest statement. I think I need to say this. I have a variety of paid consulting positions and research grants. The research grant with Haemonetics goes back about ten years. We have nothing current with them; which will become clear, why this conflict we just mentioned now, as we go forward. And I have no stock options or equities in any corporation.

Yale New Haven Medical Center was started in 1826, and currently is a 950-bed hospital. I'm going to give you a little idea of what our hospital is like, so that you can compare what we've done with hospitals that you know, to see whether it follows, if it's similar or if it's a much bigger institution or smaller.

It has a children's hospital affiliated within the school of medicine. We also do not have a donor room, an allogeneic donor room. We have a donor room which provides autologous blood and pheresis, but we do not collect allogeneic blood.

What is the reason for a hospital-based strategic reserve? And this was the idea which actually I got when I read an article in the ABC newsletter that the Red Cross was starting a national strategic reserve and Alan Ross was going to be leading this. And we decided, or I decided, that we should really put away some frozen units of blood for our purposes. The problem was to decide when to use it and how to use it. And that's what I'm going to share with you in a few minutes today.

What is the increased demand for blood at Yale? We're a Level One trauma center. Our organ transplant program is growing. The liver transplant program, which had stopped, is apparently restarting again. We do a variety of insertion of cardiac devices, redo CABG's and redo valves, all of which lead to excessive bleeding on occasion.

We have a new chair of surgery, and when I went to speak to him, I told him about the problems we had with chronic blood shortages. And he told me that he came to Yale to increase the transplant program, not to shrink it. And I told him that we needed to talk, because we didn't have a faucet. So there is an expectation that hospital directors have to deal with.

Decreased supply: We always have had for a long time acute spot component shortages, superimposed on chronic shortages. Periodic NAT testing delays: Certainly, that applies to platelets, rather than red cells. And we're also concerned about transportation delays due to weather, disaster, or terrorism.

Our blood supplier is a highly-placed, unnamed regional blood center which is about an hour away, just 40 miles. So if we had a weather disaster where there was ice or snow, where someone could not get through for a day or so, or if airports were closed, as happened on the September 11th disaster, where we could not get blood, we felt that Yale needed to have some degree of self-sufficiency.

Area hospitals rely on us in times of acute shortage. We get phone calls, "Do you have blood?", if we're closer than our regional blood center is. We do not have an allogeneic donor room, so the concept of donor surge is not applicable to us. In a sense, we are the 800-pound gorilla, and we need a plan. It's a sort of an expectation that we will be able to do something in a time of crisis.

We have fostered the "rabbit-in-the-hat" syndrome. Joe Bobey, who was the director for many years before I was there and while I was there--You got pretty much what you wanted out of the blood bank at Yale. And I did not foresee terrorism or weather-related disasters changing that. They somehow expected we would provide blood for them. And we needed to provide some type of a plan, with all the warts and caveats that there may be; we needed something.

I also believe that hospitals should be proactive. We should not sit back and just expect that the regional blood supplier will arrive with the blood in the nick of time. We needed to do something to help ourselves get through some of these emergencies. So self-sufficiency, I think, we validated internally.

We then went to the first level of assessment. We went to the chief of staff, and we asked them to reaffirm this. Why? Because they are the ones who could give us the resources, and they are the ones who would give us the clout to provide the material and person power to effect this.

And the chief of service's mandate was, as you might expect: Never cancel elective surgery, close the operating rooms, or the emergency room. Which is what I wanted, because that basically gave us the ability to ask for what we needed to really effect this.

We evaluated our daily use, and we decided, based on past evaluations, that we used about 70 units of red cells a day, 20 FFP, and 50 random donor platelets. We do not use single-donor platelets very much at our institution. Less than a three-day shortage was usual. There were local issues involved. And our blood center usually could supply us, or kept us going. If it was over a three-day shortage, that would imply a larger area disaster, and it would affect much more than just our local region.

We decided that in order to affect this we would need to get a freezer with a capacity of about 200 units, and that's roughly the three days' supply. We also needed a system which was a closed system to freeze, deglycerolize, and store, in order to have inventory flexibility. You cannot run a program like this with a 24-hour out date of a deglycerolized red cell unit. Which I why I mentioned that I had nothing to do with the corporation that I mentioned earlier.

We also needed to expand and develop an allogeneic donor room, and that meant applying to the FDA for a change in our registration.

Just very briefly, we transfuse about--all these slides will show this--we transfuse about 7,200 patients a year. We transfuse about 40,000 products, which has been decreasing through a variety of efforts. We transfuse about 20,000 units of red blood cells; about 12,000 units of platelets. We use four-unit pools. So it's roughly 4,000 to 5,000 administrations a year.

We do use some single donors. These are in the hundreds. So there's a couple of hundred single donors--primarily, cross-match compatible.

And we use about 6,000 units of FFP. Don't ask me what for; but that's what we give out. And cryoprecipitate has dropped because of the development of fiber and glue.

The rationale for the second level was we formulated an internal working group among the blood bank staff and we needed to develop an algorithm. The time to determine when you go to this reserve is not when there is a problem, but before the problem happens, obviously.

We needed to avoid "chicken little" syndrome. The last thing I wanted to do was to say, "It's a disaster, we have to cancel surgery," and then I get a call from the blood supplier, "We have blood," and then I un-cancel it, and back and forth and toggle back and forth. We needed to work out a solution where we didn't have to notify externally, yet when we did it was with good reason and we've gone through the issues.

We made a decision only to track "O"-pos, "A"-pos, and "O"-neg. We decided we would not track "A"-neg's, "B"-pos's, and so forth. And RH was no longer important to me; which was a major monolith that crumbled. But red and cold and ABO compatible was what I wanted, and if it was RH-negative and compatible, that was fine, in an emergency. If it wasn't, we have other ways of dealing with it.

Our red cell levels--again, vetted on ten years of evaluation--were about 70 units a day. Our FFP was about 60 units. This was what we wanted in the freezer: 200 units of red cells; 60 units of FFP. Platelets was a problem, and it still is a problem, because you can't freeze platelets in glycerol. You'd have to use DMSO. And that opens up an entire issue of what to do about that.

The third level was process validation. We analyzed our average usage per day, going back about ten years. And our normal old inventory is about 150 units. Fifty 100 units are routine as a chronic shortage, with blood center back-up. When we get less than 50 units in a shortage, without blood center back-up of "O"-pos, that's when we start getting nervous. And we have actually not gotten to that level. The "O"-neg inventory we felt was superfluous. It was there; that was nice. But we were concentrating on "O"-pos.

We assessed the number and volume of deliveries from our supplier. And our major goal was internal conservation and ward-specific assessment, to find where we could decrease large blood use. And a key concept was to avoid what we consider frivolous hospital-wide notifications.

We used a format of green, yellow, and red; green being normal status; yellow, high alert, but internal management; and red being internal and external management.

There are also two other concepts I need to mention: emergency blood management plan, which is our SOP for ensuring adequate amounts of blood for hospital patients in need; and the rationing plan, which is when we went into the critical red zone and we only had 200 units, who decided who got them? We're not going to discuss that here. That requires a group that will evaluate, when blood is at such a critical level that the needs of all patients cannot be met, who gets the cookies. And that's something we'll talk about in a second.

This is the overall, which I have broken down in the next two slides. These are our normal levels over here, and this shows the various algorithms. And I'm going to walk through that in a second, right now.

Look at the "O"-neg's and the "A"-pos's. Green, these are our levels for normal levels for green. Yellow is shown here. And then, red. When they get into the red level, we check our "O"-pos inventory. If the "O"-pos inventory is acceptable, then we just monitor. If it's not acceptable--that is, the "O"-pos is somewhere in the 50 to 100 range--we go to what we call a "yellow internal alert." We check the blood center and find out the fill rate for the next 48 hours. If they cannot supply us because the airports have shut down, blood has to be diverted to ground zero, there's a major snow storm, there's been an explosion at the blood center, whatever the reason, we take that into consideration. We check our frozen status. We review elective transfusion orders, and project excessive demand, and check the OR for the types of cases based on ABO type.

With that information, we can go back to monitoring status. Or if it turns out that we are still in trouble, we then call the floors and suggest cutting or postponing elective transfusions, and call the operating room and remind them about availability of blood and see what they have planned and if we can get an assessment of that.

If that gives us a comfort level that we can still maintain it and our blood supply is there, our blood support from the blood center, then we'll just monitor. If it's not okay, then we have to go to the following area. And this is where really we feel we've come up with a possible check point.

Can the blood center provide support within 24 hours? Is there sufficient liquid inventory to support elective transfusions, support the operating room, and support the OR? And if the answers to all of these are "No," we then notify what we call the "transfusion crisis management team," to go to the condition red; that is, we have to rely on the freezer completely to supply red cells and plasma.

This team will be the ones to determine how the blood is rationed. And it consists of the chief of staff, myself, the chairs of the various clinical services, hospital administration, risk management, and ethicists. And that group will decide how those units are allocated.

The adverse aspects of this: The need for the reserve is uncertain and episodic, at best. But you need to have a plan in place. We're here discussing what we hope will never happen again.

Statewide and national support have been excellent, and will likely continue to be, and we've never needed it before. If we do have to implement this going to the frozen reserve, this 200 units, will three days be sufficient?

Resources are needed: a freezer, closed-system, salt washer, possibly two, because it takes about an hour a unit, etcetera, etcetera. So we would need to start thawing. And without that 14-day flexibility, you can't run a program like this.

You need to store FFP. It's do-able. Platelets is a concern because of the need for DMSO. And we are in the process of developing a program to look at that, in conjunction with Bob Valerie [ph] and Charlie Schiffer; neither of whom I've actually notified about our need for their services.

And there's also the idea of inventory rotation. And what about charges if frozen red cells are not ordered but you need to rotate the inventory? That's a concern.

So this just sort of gives you a summary of this. Green is normal operations. This is heightened internal and focused external notification. When we get into the red zone, when there is less than 15 or 20 units of liquid or when we have to go to the reserve, this is what gets activated, with the approval of the medical staff.

Now, what about costs? Well, it's about $6,000 for a mechanical freezer. It's about $40,000 for a cell processor, and if you need two that's $80,000. Supplies for freezing 200 units, about $10,000. Two hundred units of red cells is about $34,000. FFP is about $3,000. The cost of developing a frozen platelet program is going to be around $15,000. Technologists' time.

But in the bottom analysis, the cost of a unit of blood when a bleeding patient will die without it is priceless. So we feel--with apologies to Madison Avenue for that--it is important to at least have a program in place, that has warts and has some flaws but, now with some of the technologies that are becoming available, provides us with the ability to keep the operating rooms open and keep the clinics open and transfusions, at least until a disaster that may prevent us from contact with our blood center can be reestablished.

And this was presented at the AABB this year. Thank you very much.

[Applause]

DR. BRECHER: Thank you, Ed.

We have one additional speaker, Chris Healey, from PPTA.

MR. HEALEY: As the new industry consultant to the committee, with a perspective on plasma, we thought it appropriate just to make a few very brief comments on the plasma industry perspective on disaster readiness.

It's worth noting that PPTA is a participant on the AABB taskforce. And we appreciate the opportunity to participate with the AABB and support their work and the work of all of the people on that taskforce.

Clearly, a lot of the objectives are the same, but some of the objectives are different. From the plasma industry perspective, our objective principally is to really maintain production and availability of plasma therapeutics. That means making sure that we continue to take donors into donor centers; we continue to plasma-pherese them; collect that plasma; test it; have it distributed to the fractionation facilities; and making sure that they're up and running and that all of the equipment and other components that are needed for that production cycle are ready and available.

A secondary but equally important objective is to contribute to other public health efforts. And I think that was borne out by September 11th. I know that a number of the plasma centers around the country offered their facilities for use by trained phlebotomists to come in--Red Cross and others--and draw blood there, as well. So there is a larger sense of contributing to the public health during times of emergency.

In terms of September 11th, and with regard to the production and availability, the plasma industry really did mobilize there. A number of aircraft were chartered to make sure that products were distributed around the country. Production was maintained. We saw an increase in donations from plasma donors, as the public outcry for making a contribution rose. So we really believe that those objectives were met to the best extent possible.

Our focus is probably a little bit different in the plasma industry than in the blood industry. And as you can see, ours is really on high-impact, low-probability events. That's probably a shared focus.

What we mean by that is things like product tampering, catastrophic earthquake, a terrorist donor. I mean, these are the kinds of brainstorming things that you go through. If somebody came into a donor center, knowingly infected, to try and contaminate the product line. These are things that we're thinking about, and how to prevent those and make sure that the product and the manufacturing process is maintained safe.

Logistic sabotage clearly is an issue. I think we've heard throughout the day that logistics is a challenge for the entire community, both blood and plasma; making sure that products can move around the country. So that's another area that we are focused highly on.

Current status and what we have in place now: Each of our member companies has readiness plans--they all have environmental health and safety officials on site--that are really aimed at the low-impact, low-probability, or high-impact, high-probability events. So for example, something like a fire or an explosion, hazardous materials spills--Those things are planned for at the facilities, at the fractionation plants. People are in place. There are plans already in place.

And so we say we're looking at the low-probability, high-impact events, those things that it's not easy to plan for. That's what we're trying to come together as an industry and focus on and develop some plans around.

We have made some first steps. We have a crisis communications plan in place, and I can tell you that it goes to the very highest levels of each of our member companies. We have the cell phone numbers, home phone numbers of some of the CEO's. And they're ready and available on short notice, in the event of a major crisis. So we can pull together the leaders of the industry, and take appropriate action.

In addition, we are in the process of forming a taskforce for the plasma industry exclusively. We're not quite as far as AABB has developed. And we applaud their efforts. But we are coming together and, again, focusing on those high-impact, low-probability events.

Along that line, we have some acknowledged vulnerabilities, as have been discussed here; logistics management being primary among them. Freezer capacity was an issue for us in connection with September 11th. We had a lot of donors coming in, as I say, but it wasn't always possible to get the test vials out, the samples out to the laboratories, and get those test results back so that the plasma could be released. And as a result, we had inventories of plasma in the collection facilities getting larger and larger, with limited ability to store it.

Laboratory shipments was an issue. The labs were down on occasion, due to unavailability of test kits and reagents. And then the supplies for collecting plasma and the reagents for the laboratories also were a logistical problem.

Another area that we're focused on is stakeholder communications. Clearly, this is a big part of the industry, and one that I think we all need to focus on; in general, reassuring the public. But particularly, for the plasma industry with the communities that we work with--the hemophiliac community, the IVIG-using community--it's important to make sure that we keep in touch with them and let them know that things are going to be okay and that we're trying to manage things as best we can.

We have made some gains in that regard. We participated in a CDC meeting earlier this year, and sponsored a meeting at NHF where we spoke with the hemophilia community and did some brainstorming about how to manage disaster situations and prepare.

Next steps: I think we really need to broaden our perspective of public health emergency. Clearly, there is the immediate reaction to whatever the disaster may be, but it goes beyond that. I think we need to think downstream, and think of the consequences of our response to that emergency. We saw that through the shortage of the P24 antigen test kits downstream, after so many of them were used in response to the increased donations. So we need to broaden that perspective of public health emergency, and make sure that we consider all those downstream effects.

We're also looking to develop what we call a "playbook" with stakeholders; principally, the Food and Drug Administration, but also with consumers and other industry partners such as AABB and their taskforce. But to put in place some protocols that are ready in the event another disaster does occur, so that we'll have some lock-step procedures to follow.

You know, a few quick examples are if there's product that's available and labeled for foreign distribution, maybe it's appropriate to consider having that distributed in the United States if there's a need. Are there ways that we can do work-arounds, to make sure that the product gets to where it's needed most during times of emergency?

So we look forward to continuing our work with AABB and with all of the stakeholders. And that's just my brief update of where we are. Thank you.

[Applause]

DR. BRECHER: Thank you, Chris.

We're going to now move to the Medical Industry Perspectives. As I said, we have several speakers, and we'd like to try and limit each of these speakers to approximately five minutes. The first speaker is Ms. Elizabeth Bewley, from Advamed.

MS. BEWLEY: Good afternoon. My name is Elizabeth Bewley, and I am vice president of supply chain at Johnson and Johnson Health Care Systems. I would like to share with you today a few key points on behalf of the Advanced Medical Technology Association, Advamed, which represents over 800 medical technology manufacturers worldwide, including manufacturers of blood-related hardware, software, disposables, testing equipment, and reagents, and other technology processes.

In the wake of September 11th, Advamed established an emergency preparedness council for its members. This activity now involves over 75 Advamed member organizations. We also have been actively involved in the taskforce organized by the American Association of Blood Banks to identify critical areas for emergency preparedness for our blood supply.

We applaud their efforts, and would like to highlight a few of the issues that are of specific concern to technology manufacturers. There are two broad areas that are relevant for any discussion of emergency preparedness for blood-related supplies and technologies.

The first area comprises the plans, inventories, and systems that we as a nation have in place to manage and direct supplies appropriately on a day that an emergency happens. The second area relates to Food and Drug Administration regulatory restrictions for blood technologies that make sense under normal conditions, but may need modification during times of crisis.

To give you a sense of our preparedness in the first issue area, our planning for emergency supply chain management, many of us in the industry realized on September 11th how little we knew about the supplies that were needed for the emergency that was unfolding. On September 12th, it became apparent that there was no coordination process that we could use to sort out who needed products the most, and how the products should be routed. We had no idea if we were fulfilling the same order twice; that is to say, responding to the same demand twice, through different channels.

And lastly, because commercial air transportation was largely unavailable, we had to find many creative solutions for moving products. In a nutshell, there was not nearly enough information about the key channels of demand or the nature and relative importance of the demand that we were facing.

To those of us in the supply chain management profession, this is truly troublesome. I think we all have realized that now is the time to assess the various scenarios that we could face and put into place the tools that we need to ensure our preparedness.

Here is the list of action items that we propose should be developed as part of our nation's readiness efforts. Although our focus here is specific to blood, many of these things are relevant to other medical supplies as well, and should be reflected in our national preparedness planning.

The first is disaster protocols and planning. There should be national and regional contingency plans and recommended protocols for all stakeholders, including blood technology manufacturers, for emergency supply chain management. The plans and protocols should be structured by disaster scenario and level of severity of the emergency.

The next area is blood supply issues. Protocols and planning for blood-related supplies and technologies should be coordinated with those for supply and distribution of collected blood.

Next is preparedness review. There should be a national assessment system to periodically assess our level of preparedness nationally and regionally for all potential emergency supplies, including blood and related supplies.

Then there is supply chain coordination. As a nation, we need a greater level of coordination of the distribution of needed technology and supplies during domestic emergencies. Although planning and protocols may help suppliers to sort out many of the hurdles through established channels, there needs to be a predetermined coordination point to eliminate redundancies and assist us in directing supplies to where they are most needed. For blood-related technologies and supplies, this should be coordinated with the supply and distribution of the blood products themselves, probably by the same entity.

The next area is communications. Reliable channels of communication should be developed for emergency supply chain management. There should also be a directory of key national and regional contacts developed and maintained for emergency management. That is to say: Who do you call?

Emergency transportation protocols: The Federal Government should develop lists of critical emergency supplies and provide special status to blood-related products and IV products, along with other critical medical products, so that these items can be shipped domestically and from foreign sources during an emergency.

Many blood-related products require special climate-controlled transportation. In some cases, ground transportation simply is not adequate, and special protocols should be developed to afford access to air shipments.

In the blood area it's also important to recognize that the very high level of regulatory oversight for blood products and the supplies used for blood collection and transfusion also may create unworkable barriers for management of an emergency situation.

I would like to mention three areas where our members believe that existing FDA policies should be reexamined. The first is lot release requirements. Currently, reagents for blood screening tests and other blood supplies and technologies are subject to lot release requirements that often include shipment of a sample for FDA review.

Because companies perform the same tests prior to the release of products, FDA lot release testing is redundant, and should be waived. FDA can still review company documentation related to lot release, without physical testing of product samples.

The second point is related to FDA expedited review. In determining whether to grant a product expedited review, the FDA should pay special attention to devices that have uses in emergency blood safety assurance.

The third area is blood collector licensing. The FDA should work with blood collectors, to allow for emergency relaxation of licensing restrictions, such that blood collectors can have flexibility to use substitutable FDA-approved blood-related products and disposables for items already being used under their FDA-approved facility licenses.

We think that these few steps would go a long way in allowing manufacturers to move products quickly and safely to the areas and specific health care providers that need them most.

Advamed looks forward to working with the AABB, the members of this committee, and other key stakeholders, to devise the best solutions for emergency supply chain management. Thank you for the opportunity to share the views of the medical technology industry on these important issues.

[Applause]

DR. BRECHER: We really don't have time for questions and comments in this session. I'm sorry.

Our next speaker is Dr. Andrew Heaton, from Chiron Corporation.

DR. HEATON: Good afternoon. Thank you for the opportunity to talk to the issues associated with the 9/11 disaster.

Thus far, we've heard presentations on the issues related to patients, donors, donations, regulations, and hospitals. But blood is a manufactured product, the end of a long and most complex supply chain. This chain involves the producers and manufacturers of bags, pheresis equipment, components, cleaning materials and, finally, blood testing, before the final product can be released to the patient.

As the newest element in the supply chain, nucleic acid testing could be regarded as a high-tech, complex product, and would therefore be suspected of being most likely to be the problem in an emergency. This presentation will show that this was not the case, and the nucleic acid testing performed as well or better than many other links in the supply chain.

Chiron and Gen-Probe, our partner, have both recognized that blood availability is a strategic resource. And we've therefore developed business continuity plans, or disaster plans, which of course, coming from California, is something that is especially close to one's heart.

We have developed and have completed a business continuity plan. And we recognize that critical advance planning was an essential part of a high technology service where the source of manufacture would be limited and where the product was extremely complex to manufacture.

The key planning elements included reserves at the customer site and at alternate locations. We pre-planned equipment and pre-placed equipment, both at customer sites and central locations. We developed a decentralized service support program. And we planned a distributed service and support availability.

When the disaster occurred--It's always interesting: It takes one a while to catch on to the fact that it is a disaster. And it certainly took us an hour or two before we pulled our team together. But once we did, we reviewed all the issues. We anticipated the increase in donations; we reviewed equipment functionality and availability; we assessed resupply capability and the service availability; and we reviewed orders, service orders, and upgrades currently in progress.

The outcome was that we estimated that the industry would need between two and three times increase in demand. We observed that our customers' equipment service records looked good, and they had adequate inventory of parts.

Our biggest worry was support personnel, which I will show you later was a problem since, as luck would have it, we had our engineering in service and so we had all our key personnel in Emeryville for training on the 11th of September.

We certainly looked at alternate methods of restocking. And absolutely critical in any disaster, we developed a communication plan, in order to reassure our customers and provide them with updates.

Our going-in position, therefore, was, we had a very heavy inventory in all our customers. And by virtue of the fact that NAT testing is performed in a pooled environment, we had a very large over-capacity. In fact, our months of forward supply ranged between 1.0 and 2.5 months on-site, at the customer, immediately available to support an emergency.

In addition to the on-site inventory, we had a further three-quarters of a million tests available in a central inventory. Not only did we have the tests on-site at the customers', but we had excess equipment, we had back-up equipment, and we had pre-positioned back-up equipment at a central location. So we had redundancy at the customer sites, immediately available back-up, and then sources of support in the event that the customers needed it.

Our biggest worry on the day was pretty well all our engineering staff were in Emeryville being trained. And we had very few of the customers close to our customer sites, who are depicted as red dots on this map.

Well, what happened? Well, test volume certainly increased dramatically. Thirty-six percent in our customer base, September over August. And the weekly test volume went up by 2.6 times, which was dramatic. However, I'm delighted to report that the NAT turn-around time was unaffected. In fact, nucleic acid testing results were sometimes available before EIA testing results.

Certainly, pooling facilitated turn-around time maintenance. And the main problem our customers faced and we faced was transportation restriction. And in fact, I think one of the biggest difficulties the customers faced was, even when there was a NAT test center physically closer to them, they simply couldn't switch their computer systems to transfer the testing to a more geographically proximate service.

Our engineers and tech support were rapidly available. In fact, we put them all in cars and sent them across country with supplies and spare parts just as fast as we could.

Our account managers actually assisted with sample shipment and unpacking. Indeed, some of them physically drove samples from New Jersey down to Florida, to help get the blood there to be available to be tested.

We implemented routine conference calls to support a situation analysis. But in fact, we were so quickly on top of the issues that our customers kicked us off the conference calls, because we were no longer a problem.

And in one center, where we had mechanical problems, we were able to service the equipment within 24 hours.

By 72 hours, we had redistributed our personnel so that they were close to the customer sites and immediately available to provide technical support.

What actually happened? Well, the on-site inventories gradually decreased as the customers used a lot more tests than they anticipated. Their weekly test volume went up dramatically, and then it gradually came down as you've heard reported earlier. And our test performance was excellent. We were running about a 1.5 percent invalid run rate; we saw a little bit of a blip this week; went down; went up. And the tests performed superbly well, even with technicians working around the clock two or three shifts without a break.

Customer account management incorporated a large inventory relative to usage, so we had the product. The test performance supported a rapid turn-around time. The equivalent functions and the services support back-up kept the customers rolling.

What was the outcome then from our perspective? Well, we felt we did a good job assessing disaster implications. We did a very good job of risk assessment and following up. We probably could have benefitted from an improved customer communication plan and better central control of customer communication.

We had very good pre-distribution of inventory in geographic areas. But we had to scramble to get some of our vendors to help us provide back-up when we had so many of our engineers on the West Coast and we couldn't get them back to the East Coast in time.

And lastly, we believe very strongly that we need to rehearse. And we would encourage the committee to support national disaster preparedness planning and rehearsals, in order to be able to meet the next disaster.

Thank you for the opportunity to present.

[Applause]

DR. BRECHER: Thank you, Dr. Heaton.

Now, in the interest of fairness, we have Karen Long, from Roche.

MS. LONG: Roche wishes to thank the members of this committee and the community for giving us the opportunity to participate in today's session.

In addition, we wish to express our condolences to those families and friends throughout the many communities who were directly or indirectly affected by the events of September 11th.

When I was contacted by Dr. Nightingale to participate, my first reaction was that I would suspect no one had a disaster plan in place that anticipated not having air transport readily available.

Even though Roche discussed the topic of this particular meeting in detail, for purposes of time, we have looked at two paths: How manufacturers were affected; and were our processes in place. And also, with the input of the blood community, their thoughts, which they requested that we share.

First is the manufacturers industry. As already mentioned, for those products approved and licensed that require each lot to be released from the FDA prior to distribution, an alternative path may be required. There are several sections within the Public Health Service Act that address a state of emergency. And you heard those this morning.

In addition, the regulation that requires lot release for licensed products does allow for reduced surveillance, as requested by the product manufacturer and approved by the FDA. Therefore, in a state of emergency lots may require shipment before the agency can complete and return the manufacturers' documentations. And therefore, we would need to look at this in the future for an immediate reduction in surveillance, so it could be granted to the manufacturer.

Another issue presented to manufacturers if any disaster should last for any length of time, is the availability of raw material. This is a concern. Depending on the duration of any emergency, critical raw material may be difficult to obtain, due to transportation and increased demand.

We've heard this discussed many, many times today. The first important note on any distribution is that this is a worldwide concern; not just the United States. Even though Roche has manufacturing and distribution locations throughout the United States, a lack of air transport could result in product delay.

Roche, as other manufacturers have, has a sound ground transportation fleet, which was very effective on September 11th. However, if the length of our air transport restriction had been longer, supplies to the manufacturer, our raw material, and to the customer, may have been affected. I'm glad to say it was not; but any time a disaster occurs, depending on the longevity, you may not have anticipated actions that need to be in place.

We also need to remember that we have Alaska and Hawaii to be concerned about. And without air transport, that was an issue of concern.

The other alternative which we investigated because of the lack of air transport was the use of our corporate jets. And those discussions had taken place for FAA, in the event that we needed to use the corporate jets.

One thing that Roche wishes to express to the community and to this committee is during times of national disaster manufacturers, government, blood and plasma industry, should work together. We saw that on September 11th, but that was limited and fragmented. And I think we could have done a better job.

One path that may be advantageous is, for the lack of a better term--and I think we've heard this several times today--a taskforce of individuals that are experts in their related fields, to assess what we have learned from September 11th, and to look to the future.

The specifics, obviously, we will not go into today. But we should all have one goal, and that is to look at the situation that we learned from September 11th, and take that with those experiences and move forward.

During the week of September 11th, Roche worked with the blood industry to ensure reagents and supplies were available. Subsequently, I've had several conversations as a follow-up, with the following input. And I think you're going to see a theme here that you've seen throughout the day.

Transportation: The major concern of theirs was reagent availability and sample transport to their testing facilities. Roche contacted all of their sites using our reagents, to assess their reagent inventory against the two to three times anticipated influx of donations.

All centers had sufficient inventory in place. With the anticipated increase in donation of two to three times, the ground transport was initiated, and all sites had additional inventory within one to two days. We only had one site that actually received or got caught in the air grounding on September 11th, but NAT testing was not interrupted.

One comment was this is a perfect opportunity, and maybe that's where a taskforce comes in, where we look and reevaluate the current processes and look and see if there's anything that's outdated or needs to be further developed.

Any communication issued should be clear. Some sites were not able to reach a clear understanding of the information provided. And one location said that they would not react to an immediate dispensation of information, for the sheer fact that they thought it would cause more errors within their facility; and therefore they made no changes. But testing was not interrupted at all.

Again, it's back to availability. We've heard this over and over again. And this has been discussed to a degree when it's surrounding transportation. But the one point that the individuals wanted me to make on this topic was: How do we maintain and provide the service in the blood industry in the event of an extended disaster?

Again, Roche wishes to thank the committee for their efforts and giving us the opportunity to have our input. Thank you.

[Applause]

DR. BRECHER: Thank you, Ms. Long.

Our next speaker is Dr. Mark Popovsky, from Haemonetics. And I did give him a special dispensation. He can have six minutes, instead of five.

DR. POPOVSKY: Good afternoon. I hope that didn't use one of my minutes.

Mr. Chairman, ladies and gentlemen, in this presentation I shall make three points, several of which you've already heard today from several speakers. First, that the best insurance for emergencies is an adequate blood supply of the right blood types. Secondly, that technology can enhance blood availability and the ability of our nation to meet patient needs. And thirdly, that donor education is the key to ensure a stable blood supply.

This table outlines our view of what the key blood inventory management issues are today. First, the deferral criteria, and other factors that time does not allow me to delve into, place pressure on our fragile donor pool. And, a point that hasn't been made today, donor recruitment is as much an art as a science; and that it is unpredictable; and that day-to-day collections in any one regional blood center can vary tremendously. And in my own personal experience, that can range from 80 to 120 percent of goal.

That leads to an over- and an under-representation of inventory, versus the actual demand. That in turn can lead to excessive out-dating of certain blood types, and lack of availability of others. And that is certainly underscored by Group "O" demand, which frequently exceeds that of the available supply.

When that demand is great and the inventory shrinks, then a very common reaction is for a blood center or blood centers to issue an appeal. Appeals lead to collection spikes, and increased costs, because appeals are very expensive to run. But as we've already heard today, they don't lead to a sustained growth in the donor pool.

So what are the consequences of that flow chart? Well, first, one often has, and can have, an insufficient inventory to meet the needs of the major disaster that does require blood. Secondly, this system that I described has inefficiencies in it, in both the collection and the distribution end. This system has excessive costs then that are incurred by the blood supply system.

And finally, it can lead, as data from various sources have shown, to either the cancellation of surgery, or what I call "the worry factor," which was alluded to in Dr. Snyder's presentation, due to excessively tight inventories.

That said, in the background, we must realize that the average donor does not donate many times a year--just a shade over once per year--and that where blood is collected today is not at giant corporations of the 1970s and '80s; it's often collected at workplaces or community sites that have--a workplace with less than 200 employees, or a collection of work sites where the aggregate is 200 employees or less. Thus, every donation must count.

So what are some of the responses that we in the transfusion medicine and blood banking community should consider? First, it's been stated and restated today, we need to educate donors about their true value to the blood supply. But that value should focus on their blood group; such that a Group "O" or Group "B" donor--the two types that are frequently in tight supply conditions or shortages--we should be focusing them on optimizing red blood cell production. On the other hand, we should be focusing on Group "A/B" donors to optimize those donors for plasma production. And finally, we should be looking at Group "A" donors for either platelet or plasma production.

Secondly, we need a better job at donor education. As has been already stated today, donors must understand that blood is a perishable resource and, again, that crisis-response donations don't address today's immediate need. It was the donor who came in yesterday and the day before.

Thirdly, we should increase our efficiency in the system, through automation. Group "O" and Group "B" donors can make donations on devices that are readily available today, either through red cell A pheresis, so two units are collected at a single donation, or so-called "red blood cell jumbo plasma combinations," which can yield 600 Mls of plasma in addition to a red cell donation.

Group "A/B" donors can be targeted for large plasma donations for fresh-frozen plasma purposes. And Group "A" donors--because, as already pointed out today, we often collect more "A's" than are needed--should be targeted for non-red cell uses, such as platelet pheresis donations.

To show that this based and grounded in reality, I'll illustrate an example of a large, multi-site blood collector that introduced double red cell collection in year 2000, and went from zero to 11 percent of their red blood cell production, using automation, over a 12-month period; and as a result, netted an additional 6,700 units to the blood supply from that red cell A pheresis procedure.

But in addition--important for blood banking today because of the pressures placed because of reimbursement issues--efficiency also increases through automation. And in one of these sites that converted entirely to automation, they were able to increase their units-per-collection-hour by 57 percent.

A second response--and it has been noted today by several presenters--is that one should consider building frozen red cell reserves. It can back up liquid inventories either in the military sector or the civilian sector. With automated, enclosed system technology, that was alluded to by Dr. Snyder, one can now take frozen blood, deglycerolize it, and store it for 14 days after it's been thawed; instead of systems that provided us with 24 hours of coverage.

In addition, it provides improved logistical support. Because now, instead of moving frozen units around the country, you can now move deglycerolized liquid units, and therefore obviate or prevent the problems associated with breakage.

Finally, frozen red cells then should be considered as a tool to be integrated into a total red blood cell inventory, which then minimizes out-dating. Because rather than simply holding the frozen units up until the last day before expiration, one can then rotate those inventories to supplement liquid inventories.

Something that has not been thought of or discussed today is a technology that has been available which should be considered as a tool to improve our blood supply. Interoperative auto-transfusion has been with us now for a quarter century. It's a proven and safe technology. It's clearly useful in both the trauma setting and the emergency room and operating suite, as well as post-operatively. And it can indeed reduce allogeneic blood requirements.

So in conclusion, blood donors need education about their potential to the blood supply. Automation of blood collection and processing can assist, by providing smarter collections, by collecting and targeting the types that are needed. It can improve productivity and improve availability. And finally, tools such as frozen red cells and interoperative auto-transfusion can enhance whole blood availability. Thank you very much.

[Applause]

DR. BRECHER: Thank you, Mark.

Our next speaker is Susan Reardon, from Ortho Clinical Diagnostics.

MS. REARDON: Thank you very much. I'm Susan Reardon. I'm the director of reimbursement and health policy for Ortho Clinical Diagnostics. It's a pleasure to be here today.

We are, of course, part of the Johnson and Johnson family of companies, and are one of the very few companies in the country that are licensed by the FDA to supply reagents and cross matching and blood typing and infectious disease tests to donor screening centers.

This is just a list of most of the products that we supply in this area.

On September 11th and in the days following, we, like many of the others, were challenged tremendously by the transportation issues. We enlisted the help of the Volunteer Pilots Association. We had "angel flights." In addition, we were able to commission several of our corporate planes and helicopters to fly needed supplies to blood centers throughout the whole country. This picture on the right is one of our corporate jets.

And then, in addition, we're challenged because we supply these products, along with all of our clinical chemistry products, worldwide. And we ship on a daily basis. So we needed to get some of that equipment and supplies to foreign countries as well. So we had to get special permission from the FAA to get a cargo transport over to Europe.

In addition, we had production concerns. Many folks have talked today about the need to ramp up production three times. That's difficult when you're talking about the types of products that are involved here, biologic products. They're fragile, and the cycle times involved in the production are long.

We also had issues with the FDA license procedures. There is a provision of the CFR, 21 CFR Part 640.120, that allows for variances from license requirements. For example, OCD's product license for assays for infectious diseases requires 14 days of sterility testing; which was a time requirement that we couldn't make, given the demands for our products. And while we ultimately were able to get these waivers, the process was challenging.

Now, I used to work in government. I used to work at HHS. I was in the general counsel's office. And I know that you, as an advisory committee, would like to make some recommendations to the Secretary to improve the process. So I have some very specific recommendations. And some of them hark back to what's been said before.

The first recommendation is that we believe that there should be alignment of emergency preparedness plans at all levels, with specific procedures in all of those plans directed to blood safety and supply issues. This includes every plan that has been mentioned today, and several others that are probably existing out there.

There should be a core set of elements in those plans. That includes transportation and communication and the like. And there is a coordinating role, I believe, for HHS and its experts to work with the AABB and other appropriate bodies, to make sure that all of those plans are in fact aligned.

Our second specific recommendation is that we, like others, believe that a single voice is absolutely essential in order that the right messages get out in times of emergency. We believe that it should be a government designated body with full official authority and accountability to provide clear direction in times of emergency.

The Office of Homeland Security is probably the right-hand arm of the President in times of terrorist attacks, and would be one of the logical places that would be a good party to exercise this voice. So we are recommending that that office be included.

There is also, I would mention, a Citizens Corps that's been established recently by that office, that would involve citizens in emergency preparedness, and could include blood as well.

We note also that HHS has a key and critical role, one that's codified in the Federal Emergency Response Plan in the emergency support function number eight. We believe that that FRP emergency response function eight--I'm sure it's got an acronym of some sort--should be revised and revisited, just as some of our previous speakers have mentioned--Mr. Fitzpatrick, commander, or captain--whatever. I'm sure you've got some high title.

[Laughter]

COL. FITZPATRICK: "General."

MS. REARDON: General. Okay. You'll take whatever you can get.

[Laughter]

MS. REARDON: But that particular plan needs to be specifically revisited and revised. And we believe that it needs to be revised to specifically add AABB as one of the official support agencies, in addition to the Red Cross, that the government looks to for support in these kinds of emergencies. We further believe that the FDA role needs to be further defined within that document, with some specific responsibilities.

Now, let me just go back up for one quick second here. Because the other key element here is that with regard to the alternate procedures that the regulations now authorize, we believe that FDA should develop not only its internal SOPs--which we were glad to see they've decided to do--but to also develop a guidance document that would be available to those of us in the industry, so that we would have a clear idea as to what processes and procedures to follow in these particularly trying times.

And then recommendation three: We agree with what's been said, that the emergency cry for blood is, in very many situations, if any, going to actually be there. But the need for blood is there on a daily basis. And we believe that we have a primary opportunity, a window of opportunity, to have the Secretary--perhaps, even the President--use the power of the "bully pulpit" to motivate Americans to register as blood donors to donate regularly. We endorse what the ABC and the ARC are doing to create strategic donor reserves.

We would like to see this committee recommend to the Secretary that he use his power, that the new Assistant Secretary use her power, to encourage and educate Americans throughout the country to become part of the strategic blood reserve.

Finally, I just wanted to mention that, as part of the Johnson and Johnson family of companies, we are very serious about the importance of our credo. We live by this credo. And never more so were we required to live by this credo than in this very trying time and difficult time for all of us and the industry. And it says: We believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services.

Our employees work night and day to fulfill the needs of our customers. And because of our very personal experiences with this tragic time in our history, we are intensely interested in doing our part to improve our nation's response to an emergency. If we can help strengthen the nation's fragile blood supply at the same time, we will be enormously gratified. Thank you very much for your time.

[Applause]

DR. BRECHER: Our next speaker is Ms. Susan Sanborn, from Abbott Laboratories.

MS. SANBORN: Good afternoon. I'm Susan Sanborn, with the regulatory affairs department for the Abbott Laboratories Diagnostics Division. And I'm substituting today for Mat Klamyrzinski.

I'd like to thank Dr. Nightingale and the committee for allowing me to share the issues and lessons learned regarding product availability during a disaster such as September 11th.

I'd like to focus today on three issues. And several of these issues have been discussed by previous speakers, and I think we've come up with the general theme of the day. These issues are: transportation, finished goods inventory, and the suppliers or vendors of parts and raw materials.

In regards to transportation, I think it's been said several times today, our biggest challenge was the cessation of air shipments immediately after the September 11th events. Critical blood-screening tests that are labeled must be delivered between 24 and 48 hours unless they are refrigerated. And we were able to deliver our products within 24 and 48 hours by land transports to 80 percent of the U.S. The remaining 20 percent of the U.S. requires refrigerated trucks for transport times that exceeded the 24 to 48 hours, and have to be mobilized quickly when air transport is not an option, such as it was after September 11th.

The lesson learned from this then is that government could help us with some of the transportation challenges, with an access channel to military aircraft capability for a disaster area. Or possible arrangements could possibly be made with the National Guard to coordinate deliveries to needed locations.

In regard to the finished kit inventory, most of our blood-screening products have a 30-day supply availability. The upsurge in demand during the September 11th crisis reduced some of these products to critical levels. During the disaster recovery after the initial crisis it is taking more than three months to recover to normal inventory levels with our existing manufacturing capabilities, when about a 30-percent increase in demand continues.

Some of the lessons to be learned with that: As has been talked about previously today with lot release, for products having less than a three- to four-week inventory at a manufacturer, perhaps alternate procedures in regard to the FDA lot release should be considered.

Possibilities would be concurrent lot release upon submission of the lot results protocol to the FDA for products that are subjected to the lot-by-lot release. This is especially important if the telephone and fax lines are disrupted, or until normal testing demands come back.

Increasing our inventory levels by two-fold in alternate warehousing sites for our critical blood tests could also be considered by the manufacturers.

And lastly, as has been indicated, perhaps monitoring by either an emergency coordinating body or group, or perhaps a taskforce, of the needed blood tests should be performed in order to prevent over-collection of the units and subsequent draining of our test kit inventories.

With regard to our manufacturers, suppliers, or vendors, the manufacturers need to be vigilant with their supplies of materials for blood tests and equipment, in order to carry adequate inventories for accommodating a sudden crisis demand.

Visits to the suppliers by the test kit manufacturing personnel to encourage the vendors' participation in a disaster plan recovery is essential. An emphasis would need to be made on the vendors' roles in keeping their inventories and critical materials at high levels for rare reagents and hardware for instruments.

Thank you very much for your time and allow us to participate.

[Applause]

DR. BRECHER: Our next speaker is Mr. Patrick Schmidt, from FFF Enterprises.

MR. SCHMIDT: Good afternoon. Mr. Chairman, Dr. Nightingale--General Fitzpatrick--

[Laughter]

MR. SCHMIDT: It's a pleasure being here. I do realize that I am the speaker directly prior to the break. And there's three rules of presentations, if you're the speaker right before the break. Those are: Be direct, be brief, and be seated. And I plan to follow all three of those.

DR. BRECHER: Actually, there will be one other speaker.

[Laughter]

MR. SCHMIDT: Then forget the "Be Brief" part, then.

My name is Patrick Schmidt. I am the president and CEO of FFF Enterprises and our family of companies, which include Life Tree Technologies and New Factor. I will be brief, and I will talk quickly.

Three-F Enterprises, as I refer to us, is the largest distributor of albumin and IVIG in the U.S. We store huge quantities of albumin IVIG in our single location, Tumecula, California. From that location, we service 80 percent of the hospitals in the U.S. with albumin intravenous immune globulin. For 14 straight years, we've been on service, handling emergency requests for home care companies, hospitals, and hemophilia treatment centers.

The events of September 11th I think changed all of our lives dramatically. Upon first news of the attack, we went through the same uncertainties that everybody else did: Was it an accident? Ultimately, our worst conclusion was realized; that it was terrorism.

Our second thought was: How widespread were the attacks? And we learned within moments of the attack that hospitals in the areas affected by the tragedy began to call us as their primary supplier. That's one of the things we learned. I think people in a time of disaster look to their primary resource for the products they need.

Reports of thousands of injured were coming in. And as we all know, and have talked about already many times today, all flights were cancelled. A very unique experience.

We learned in a situation like this that you have to think the unthinkable: Ground transportation blocked. Again, air cargo space unavailable. Our ability to get product in an emergency overnight, or within hours, was severely hampered.

In response to that, and based on our responsibility to the hospitals that we serve, we looked at our emergency SOPs. And I've heard other people today say that theirs were limited in scope. Ours were, too. They were not designed to cover an event of this magnitude.

So we rapidly explored alternatives. Simultaneously, we loaded 94 pallets of 25,000 vials of different medications--human serum albumin, TB vaccine. And we cooperated with the local American Red Cross, and transported some skin grafts via chartered aircraft that we obtained emergency clearance for that evening, Tuesday, September 11th.

That product arrived in Philadelphia at 8:45 p.m. Eastern Standard Time. And a convoy of trucks was awaiting it, and delivered that product--the human serum albumin, TB vaccine, etcetera--to 54 D.C. and New York area hospitals.

There was uncertainty as to when the airlift ban would be lifted. Would it be days, moments? Our additional contingency plan that we created on the spot with our triage team was to send some additional products into an East Coast location where we partnered with one of our business partners, Corm Health Care. And we stored product there in the East Coast. And we supplied the regular, ongoing, continuous demand from that location for the next couple of weeks.

The hopelessness of the situation was, the albumin that we sent in anticipation of the injuries that were reported was, unfortunately, not needed. But unlike the blood products we've spent much of the day talking about, albumin continued to be used for the regular ongoing demand for the next several weeks. It was not returned and, because of the dating on it, did not out-date.

And what we've learned is, cellular and land telephone lines were overloaded; but, besides the major news sites, the Internet was relatively unaffected. I'll never forget when I heard that the Pentagon had been bombed, or a tragedy had occurred at the Pentagon. I sent an e-mail to some friends of mine at the national headquarters of the American Red Cross: "Are you okay?" Response back: "Yes, but the Pentagon is burning." I will never forget that. But the Internet--my major point here--remained largely unaffected.

So how has our world changed? Our New Factor Division services people that have hemophilia--And speaking to some of those folks. Tighter airport security measures: We've all been through it. I bet everybody in the room has probably had to take their shoes off at least once or twice here recently. And they are different at every airport. There is very little standardization. And it's difficult to get any needles and syringes through security. And in some cases, and with some of the gentlemen that I've spoken to, they'll check their luggage. So now they're separated from their personal factor supplies. So that increases, in my opinion, the health risk.

And all of us in this room probably traveled to get here. If there's anybody that's never lost luggage in their lives, consider yourself quite fortunate--But I'm sure your experience is coming.

Another concept, an idea that we have tossed about: In our inventory we carry nearly 1.5 million grams of IVIG. It's a huge supply of inventory. People supposedly in the know--I'm just the CEO of our corporation; I do not know--tell me that there's possibly high-titers antibodies, vaccinia antibodies, existing in our inventory.

Our suggestion would be to establish a program to identify newly-manufactured lots. That product would be on hand to address adverse events associated with large-scale smallpox vaccinations. And we would have a rolling inventory. I think somebody earlier today mentioned feathering inventory in. And we would keep a national asset there, intact and in-date. A concept I think worthy of consideration.

From the National Disaster Medical System paper, Public Health System Reports, I noticed this comment: "Our ability to care for mass casualties will require creative new ideas." We have some ideas. I can't say how creative they are, or how good they are. Our company has been credited with having lots of ideas--very few good ones, though.

[Laughter]

MR. SCHMIDT: Health and Human Services directly after the September 11th attacks published this news release:

"HHS' new daily blood monitoring system, which began operating last month, shows that reporting hospitals have five to six days' supply, which is considered fully efficient."

On thing we saw very little of was messages of reassurance. Our company did it. This to me is a message of reassurance: "Fully sufficient [sic]."

And they're using our Life Tree technology to accomplish this. Here's a screen shot from our technology--maybe talked about later on over the next few days--where we're capturing data from 29 sentinel sites.

So future solutions: Our ICTM data capture tool was integrated relatively quickly to help monitor the nation's blood supply. We have another system, very similar--we call it the "Integrated Emergency Medical System"--which does serial bar code scanning via web-based system; which will give instant availability--and you'll have to use your imagination here--instant availability on products considered necessary to respond to a national disaster, national tragedy.

And we've determined logistically--Take, for example, if you want to know at any given time how much albumin was in the system, as an example, we considered maybe 200 locations, and we knew exactly what their material levels were. Able to respond instantly to any emergency.

And I don't want to pick on the Northeast again, but let's say something happened in the Northeast. We could have instant availability of information, by region. It could be blood products, it could be beds, it could be physicians--any information that's necessary to track. And this information could easily be made available to ESF-8.

We can scan via bar code; we can scan photo identification; give a complete accountability for either individuals or individuals who are monitoring supplies or reporting what their various inventories of whatever product this committee or others would deem necessary.

We can scan locations so we would know by location, by rack, by position, by room in a treatment facility, where these products are located. We can scan an individual product, cases of products. And all this inventory can be instantly available, by location, via the Web.

We have this technology today. Again, whatever needs to be tracked, if in fact it does need to be tracked, is limited only by our imagination. I have some examples of some things there that potentially could be.

So next steps, and in conclusion, I think we need to identify specific risks associated with different patient groups. I talked about some; that some members of the hemophilia community have communicated to me about not being able to carry their factor onboard, or the inconvenience of doing so, because of the heightened and stepped-up security measures.

We have centralized distribution of one product by the Alpha One community. I think that creates some inherent risks there. And our suggestion would be to have meetings with the stakeholders to agree on what the risks are, and what the plans are to mitigate those risks, and coordinate technology.

I think it has to be a coordination of technology, private enterprise, and establish the government rules in that regard.

And we pledge all of our resources at 3F Enterprises to "Helping Health Care Care": Our credo. And I've never been prouder to be American. I say, God Bless America. Thank you very much.

[Applause]

DR. BRECHER: All right. The last speaker of this session, Mr. James Weston, from Biopure.

MR. WESTON: I'm the last member to speak here before the break. Good afternoon. I'm Jim Weston, from the Biopure Corporation.

The tragic events of September 11th have raised our awareness of the logistics needed to maintain our nation's readiness for urgent and life-threatening medical situations. The Biopure Corporation supports the efforts of this committee today to address key issues to strengthen the safety and availability of our red blood cell supply.

We also would like to share with the committee information on a new class of oxygen-carrying solutions that in the future could be immediately available to stabilize critically-injured victims and allow corrective surgical procedures to occur without delay. We urge the committee to consider the important role that these products could serve in the future to improve patient care.

As we know, the 24-hour period immediately after a major disaster is the most critical one for treating victims. During this time, any immediate need for red blood cells can only be met by the local inventory procured through recent collections. When a major disaster occurs, local inventories of red blood cells, as we know, may not be sufficient to meet the immediate medical needs.

The blood banking industry and the American public have clearly demonstrated their willingness to respond during a national disaster. However, the highly regulated, individualized procedures for the collection and processing of blood do not always allow them to be released for at least 24 to 48 hours without compromising safety.

Transportation to the disaster area can add additional time; particularly when elements of our transportation infrastructure are affected, or when biological quarantine of an area could occur. Local red blood cell collections could also be compromised due to donor exposure to bioterrorist agents.

Increasing the immediately available inventory could also result in patients routinely receiving older red blood cells, which have been shown to have a temporarily reduced capability of delivering oxygen. Thus there remains a need for a readily available supplement to red blood cells to provide immediate benefit to victims of a major disaster.

The Biopure Corporation develops, manufactures, and supplies a new class of pharmaceuticals called "oxygen therapeutics." One product, our product called "Hemopure," is an oxygen-carrying drug that is immediately available, is ready to administer without cross-matching and typing, and is capable of being stockpiled at temperatures locally of 2 to 30 degrees Centigrade for long periods of time, up to three years.

Results from two red blood cell controlled clinical trials in general and orthopedic surgery show that a greater percent of patients receiving Hemopure avoided red blood cell transfusion in the first 24-hour period.

Hemopure is currently in investigational use in the United States. But it's approved and currently being used in the Republic of South Africa to treat acute anemia and avoid donated red blood cells in adult surgery patients. Its uses have included urgent medical situations. And we plan to file marketing applications in the U.S. and European Union this year.

Therefore, our recommendations to you: As oxygen therapeutics like Hemopure become approved in the U.S. in the future, we request that you consider their use to, first, enhance the local capability to respond to immediate needs for oxygen-carrying solutions, including red blood cells and alternatives; second, to allow for a more efficient, less reactive response to red blood cell demands; and third, to lower our overall inventory and stockpiling costs.

On behalf of the Biopure Corporation, I thank you for the opportunity to provide our views and strategies. Thank you very much.

[Applause]

DR. BRECHER: All right. We will take a break of 15 minutes. And we still start again in exactly 15 minutes.

[Recess, 3:22 p.m.-3:40 p.m.]

DR. BRECHER: All right. We're going to get started, so everyone take a seat.

Our next speaker is Ms. Judith Chapman, from the National Blood Service, United Kingdom, talking about "Monitoring the Capacity of the Blood Supply To Meet Demand." Judith.

MS. CHAPMAN: Thank you, and good afternoon. And I'd like to thank you for inviting me to share the scheme that we've implemented with the English National Blood Service with you. And this scheme has been implemented to try to get a feel for how we can monitor the blood supply within the English National Blood Service.

Just to give you a feel for the kind of communities that we're serving, we have ten National Blood Service centers that are involved in processing, testing, and issue. And we have five NBS centers that just issue units, but have other areas of work going on. And those are represented on the screen there.

And then I've also put a pie chart just indicating the donors and the non-donors within each of the regions that these centers are serving. And you can see that the proportion of active donors is relatively small, to the population that is served.

So how do we go about monitoring our blood stocks? Well, little was known about what was happening with blood stocks within the English National Blood Service, and so the government decided, in their wisdom, that more should be known about what was going on, and the whole blood supply chain should be effectively managed.

So in partnership with hospitals that the NBS was supplying, we set up this national blood stocks management scheme. And it was implemented on the 1st of April this year, and it utilizes a Web-based system for hospitals to submit their data. And in return, they get instant graphical feedback. And I'll show you some examples of the screens that they can access that they get.

So data submission is there, this data management system that's accessed through the blood stocks management scheme website. Each participant has a secure ID and password, so it's all very secure.

We collect data on the level of unreserved red cell stock for each day in the hospital blood bank. We collect data on red cell wastage according to four categories. And those categories are: time expired; out-of-temperature control outside of the laboratory; out-of-temperature control inside the lab; and miscellaneous episodes.

And then, during specific time periods we also collect data on allocated stock, so stock that's held within the reserved fridge.

And then, we collect data from the National Blood Service on their red cell stock levels and wastage. And that data is automatically downloaded from their computer system.

This is our stock entry page for hospitals that are in this scheme. And you can see here that they can set the date, and then they just tap down these fields and enter their stock levels. And they provided us with what they think their ideal stock is. And then, this nominal one-day stock is their annual issues divided by 365, and we roll that on every six months.

They can also enter information on impacts. So this is if there is a shortage within the Blood Service of available blood, then they can according to these levels tell us whether there is an impact on the lab or whether there is an impact on the patient, whether operations are cancelled.

And they can also make comments here that we can access--so if they've got a patient that's requiring a large amount of blood that they don't normally stock.

This is the wastage page. And again, we've got the categories, and they just tap down these fields, entering the wastage, and submit the data into the system.

They get graphical displays. And the data management system has data extraction facilities, and they can access these. And they get graphical displays on the issuable stock index, so in other words, how much blood they are holding, and that's basically how many days' worth of blood that they're holding; how much "O"-neg blood they're getting; the shelf life of the stocks that they have; and their wastage.

And one of the nice things about the system is that the users can actually benchmark their performance against the other participants. They can either benchmark against all of the participants, or they can select different categories of hospital and facilities within that hospital to benchmark against.

So this is a graphical display of the stock index graph. This is slightly different to the one that you've got. Something happened with the data that I sent Steve. But basically, this is the average of all the participants here. And then, this will be a selected hospital here. And the average for the whole time period is this hatched line.

So they can see very well whether they're actually performing well against the average of all participants, or whether they're above.

This is one of the wastage graphs, and shows wastage by category. The green is the time expiring; and the yellow, out-of-temperature control outside the lab. And you can see, there's quite a lot of that wastage going on. Again, there's another graph that will show each site how they're doing against the other participants. And we've found that's a really effective tool for the participants, to actually look at the way they're handling their blood, and reducing their wastage.

So as of this week, we have 167 hospitals onboard. That's 54 percent of hospitals that are served by the Blood Service. Participation in this scheme is entirely voluntary. So if they want to do it, they can do it. And they can choose not to belong.

It's free. They don't have to pay. However, there is a premium on the price of a unit of blood. So the cost of a unit of blood went up by approximately 10 pence, to actually fund the scheme. So it wasn't a huge amount. It's 84.56P a unit.

Seventy-six percent of the hospitals that are onboard are teaching hospitals, so they will have medical schools attached to them. Fifty-seven percent district general hospitals; and that's just your sort of basic hospital doing average surgery, medicine, etcetera. And then, we have 31 percent of private hospitals. We have a number of private hospitals that are relatively small. And we've found that getting the private hospitals onboard has been a bit of a problem, but we're working on that at the moment.

These 167 hospitals take up about 1.44 million red cell units. That's 65 percent of the National Blood Service issues. So we think that's a pretty good take-up, considering we're only nine months into the scheme.

One of the nice things about this is that the people involved with the system--so that's me and my two colleagues--are able to access the data, the raw data from the database. And we can manipulate it ourselves. And in the next few slides, I'm going to show you some of the data that we've got out of the system.

This graph here is available on the National Blood Service website, so the general public can have a look at a graph very similar to this. But basically, the Blood Service trucks the blood supply over the year, or the stock levels. And you can see, we have a target stock level over the year, and this is gained from some work that's been done over the supply in previous years.

And then, we have a minus-one-day stock and a plus-one-day stock. And this red line is actually how the stock level is this year. So it's not actually too bad. And it fairly well mirrors the ups and downs of the requirements. I should say that we hold about three days' stock within the National Blood Service centers.

This is a graph of the red cell issues to all of the hospitals that are in the scheme, from the start of the scheme in April to December, here. And you can see the rise and fall in levels for all the groups. But mainly, for the "O"-pos and "A"-pos, the rise and fall is more marked.

This graph is the National Blood Service's, really, day stock level for the different groups. I know it looks a bit busy, but you can see here, this red line is the "O"-pos level. And we did have a bit of a problem in May with "O"-pos stocks, and we were down to about 0.8 of a day's worth of supply. And there was a real issue as to whether we'd declare a shortage. We didn't, and we got over it. So we haven't actually declared a shortage within the English National Blood Service now for over two years. And part of that is actually careful monitoring of how we look after the blood.

So this just gives a neat graphical display of each of the groups and how we're doing. And it was interesting, hearing Marc saying about the shortage of "B" and "O." And these are the two groups that we find are in short supply most of the time.

I'll just briefly whiz through these next few graphs. This is the "O"-pos issuable stock index; so basically, a day's worth of stock in the blood banks within the participant hospitals. You will see in the next few graphs that the private hospitals have much more blood than the teaching hospitals, which are those represented by the yellow line. The red line is the average for all participants. So the district general hospitals actually followed this average very closely.

So we have a similar pattern with "O"-negatives; again, a similar pattern with "A"-positives, "A"-negatives, "B"-positives. Again, the privates go up and down. They tend not to hold "B"-positives in stock, so it really is according to demand.

The next is very different. The private hospitals really don't hold much "B"-neg at all. And you can see that the teaching hospitals are very much up and down in the day's worth of stock that they're holding. And "A/B's," again, the privates are well ahead of the rest of the field; and "A/B"-negs they tend not to hold.

And this is really a summary of all of the participants, and the lows and highs of the issuable stock levels. So the ranges for "O"-pos are really quite small, 1.1; for "O"-neg, 1.5; "A"-pos, 1.1; and so on.

The "A/B's," we tend not to worry too much about, because hospitals are issued with "A/B's" on a sale-and-return basis. So what they don't use and they send back, wastage, they actually get refunded for.

Wastage is interesting. This is National Blood Service wastage. And you can see here that most of it is miscellaneous. So that will be DAT-positives, short volumes, etcetera.

This hiccup here in May was due to a recall of some of the bags where a fault was found. So the wastage did go up quite considerably in May, due to that recall.

In the hospitals, this is just a display of "A/B/O" wastage. We lumped all the "A/B/O" groups together, bar "O"-negative. And you can see, there's a rising trend in wastage, which is quite interesting; seeing as hospitals have said they're more aware of their wastage. Similarly, with "O"-negative there's a rising trend.

And I think these yellow bars are really quite worrying, that we don't know what's going on outside the laboratory with some of our blood banks.

"A/B" wastage is very high. But as I say, we're not too worried about that, because they have it on a sale-and-return basis, just to try and get them to use "A/B's," rather than "A's" or "B's" or "O's."

And this is all hospital wastage here, and it's running at an average of about 3.2 percent. And we don't think that's too bad, considering we're taking "A/B's" into account there, as well. If we just looked at "A/B/O" wastage, it runs at about 2.6 percent; and "O"-negative wastage, just slightly higher.

So finally, what do I think the value of this scheme is? Well, it certainly facilitates monitoring of the blood stock levels, both at the blood centers and within our user sites. And it's become a very powerful tool in allowing us to know what's going on in our facilities.

And I think this will come into its own if in the U.K. we introduce further donor deferrals for BCJD. And we're doing a lot of contingency planning at the moment, and working on various scenarios from a 10-percent to a 50-percent shortage in our blood supply.

The graphical displays enable peer review, which we have found has been a powerful tool. We have many hospitals ringing us up and saying, "We've introduced new systems in our stock management program, thanks to the graphical displays. And all the people in the lab want to change practice, so that we're performing better than the others on the scheme." So that's good.

And then, we've introduced a series of ad hoc exercises which we hope will give us better information on the issues that affect stock management. I think there's a tendency for the hospitals--and this is someone who has come from a hospital transfusion laboratory--to really not be aware of our blood supply management. So people just open the fridge door, guess the amount of blood that they need, and phone up the blood service and ask for it. And I think attitudes have to change.

And we just completed our first questionnaire. And I've brought with me a 28-page document that we are going to send out to our sites, just letting them know what's going on with their blood-ordering practice; how few staff in the laboratories are trained; and actually, what they should do about ordering blood, and how they should manage the supply.

So we really feel that this scheme is a very powerful tool for helping the hospitals and the Blood Service to monitor the blood supply.

And finally, this is our website address. And if you'd like to visit it, there's lots of information on the scheme on that website. Thank you.

[Applause]

DR. BRECHER: Thank you, Judy. It's impressive that you've been able to pull this off in the last nine months.

I think we have time for a question, or a couple of questions and comments, if there are any. Go ahead, Keith.

DR. HOOTS: I was wondering, does the National Health Service either abide or actually encourage autologous pre-surgical self-donations? And if so, what's the impact of variant CJD on that? And is increased out-dating as a result, if you do do it, maybe accounting for some of those unexplained losses of units?

MS. CHAPMAN: They do encourage it in a way, but it's not actively promoted. But it's one of the things that the BCJD contingency planning group are looking at. And it will become an issue, and definitely will get a higher profile within the hospitals, and they will be encouraged to use autologous units.

But at the moment, it's very few transfusions that actually are through autologous.

DR. BRECHER: Harvey?

DR. KLEIN: Noting that your overall wastage is going down, but the hospital wastage is going up, I wonder, is there a financial incentive for hospitals not to allow blood to out-date on their shelves? Or are the centers simply sending it to the hospitals where it's being out-dated because it's not being used as efficiently?

MS. CHAPMAN: It's a good question. And the price of blood is just about--in April--to go up from 84 pounds to 99. And I think that will focus people's attention on the amount of blood that they're wasting.

And we've actually done some figures. And we reckoned that the total for wastage, just projected figures, is something like 1.5 million within the Blood Service hospitals. So it's a significant amount of money. So that's one area that we are actually trying to focus the hospitals' attention on, so that they don't waste as much as they are.

DR. BRECHER: Okay. Thank you, Judy.

MS. CHAPMAN: Thanks.

DR. BRECHER: Our last speaker of the day before the public comment is Steve Nightingale, talking about monitoring that the HHS has been doing of the blood supply in the U.S.

DR. NIGHTINGALE: Before I begin my own presentation, I would like to join the committee and the audience in thanking Ms. Chapman for being here, and congratulate her on an effort that we would do well to emulate, and that we will try to.

The introduction that I will give you is basically the introduction that I gave you in August, when we got started. The project that I am describing is an attempt to monitor the ability of the United States blood supply to meet demand. And that is precisely what this project is about. It is not just a monitoring of supply; it's not a monitoring of demand. It's trying to find out if there is a balance.

And we are doing so by monitoring inventories and releases at three sentinel community blood services and 26 sentinel hospital transfusion services geographically distributed around the United States.

And the methodology that we use is daily e-mail reports of units of blood and platelets in inventory, units transfused, units exported, and units outdated, by A/B/O and RH, or by single and random donor in the case of platelets.

And the particular comparison that we're making is we are trying to correlate these observations with, again, daily e-mail reports of actual or potential product shortages. We think simply the release by itself, without correlation with either potential or actual shortages, is of much less value than the correlation itself.

The particular indicators that we are presently using of either actual or potential shortages are as follows. For the actuals, has emergency surgery been delayed, either one to 24 hours or greater than 24 hours? Has scheduled surgery been delayed, or has scheduled surgery been cancelled? We ask each site to report this information each day. If a surgery is being delayed, elective or otherwise, that's what we would consider a direct hit.

If an order is delayed for one to 24 hours, or greater than 24, order not filled, or purchase from alternative supplier, for want of a better word, we're calling that a near-miss. Perhaps no blood, no foul, is not completely applicable here. But what we'd really like to be able to do is identify a predictor of a problem, rather than a problem itself.

And third, we have some indicators for which I really don't have a classification yet. The questions that we ask are the questions that have been suggested by the group and codified based on their collective clinical experience.

One of those questions: Was a physician consult required for orders required due to shortages? Well, this is practice dependent by site at the moment, and I really don't have that filtered out yet.

Has RH-positive blood been given to an RH-negative patient? Not according to policy. Again, that's one that I haven't figured out yet.

And the third: Have any other actions been taken in response to shortages? We get free text information--We have the capacity for people to enter free text information every day. By and large, there has been very little of that. Most of the time, we have just the boxes are checked off.

The one indicator that we do not have here, that Ms. Chapman has, but that has been suggested in our discussions and I think we'll proceed to, is an indicator of blood on the shelf. We don't ask that. Has a particular threshold of comfort been broached? We're going to have a telephone conference in the middle of February to try to get at that level.

The participating sites are the same as I presented when I spoke to you in August on the 24th. We have Northeast; we have South; we have Midwest; we have West. And our three community blood services are Florida Blood Services, Puget Sound, and Institute for Transfusion Medicine. And the other participating site: our office. It's a pleasure to acknowledge the contribution of my colleagues Captain McMurtry, Ms. Wannamaker, Captain Silverman. This is their work; proud to participate.

It's also a pleasure to acknowledge Life Tree Technologies. They have given us superb service, and it's, again, a pleasure to acknowledge that publicly.

To the data. This is the daily inventories that we have gotten from our three community sites. That's in the red. And at the bottom is the daily outflow. You can see an obvious bump in the community sites immediately after September 11th.

There are a couple of points around the middle of November. There's a sudden drop, and a rise. One of our sites didn't report on that day. This is sensitive. If you miss a data point, it's there. You're looking at raw data here, and that's intentional. They were back to normal the next day.

Right on February 1st there is a spike. Somebody hit two zeroes when they were supposed to hit "zero." And instead of having 20 units of--oh, I don't know, 200; they had 2,000, I think it was, of a particular type of blood. And that's been corrected.

This gives you an idea of how we're trying to verify the accuracy of the blood. We run this graph every day. When I ran this Tuesday at noon, we had identified the error, but had not corrected it. And I wanted to give you the raw data, rather than the prettied-up data.

You'll see a drop on the last two days, because one of our sites doesn't feel that they can give us accurate data for how much blood was actually used in the community hospitals for 48 to 72 hours. So there is a lag at the tail end. So we're sensitive to within a week, but we're not sensitive to a day, with our current methodology.

And this slide is of the 26 sentinel hospitals. And you will notice that there is less of a bump after September the 11th. And most of that bump, in fact, is attributable to the hospitals that collect a substantial, or even a majority of their own blood. Dr. Snyder at Yale University is not a member of this consortium, but my guess would be that they would not have the post-September 11th bump, based on analysis of our own data. And the local hospitals worked off their supply by about November 1st.

The one other difference here that you see between the three big community centers and the hospitals is that the trailing average is a little bit slower. Not everybody reports at 8:00 on the morning after. We're working on that, but we don't pay them that much. And in fact, what we're really interested in here right now is accuracy. It's in everybody's best interests that we know what the limitations of our current methodology are so, among other things, we might be able to make it better.

As you look at the total here, I want you to look at the area in January. You may be able to talk yourself into a slight fall-off after the 1st of January. I'm not sure that I see it. I'm not sure it's definite. But watch that spot when we get to "O"-negative and "B"-negative down the road.

What you saw in the last slide, you see, there's about seven or eight--On an average day, all our sites report that they have seven to eight times as much blood on the shelf as they are distributing in a day. And while that sounds like there's a big cushion, the feedback that I've gotten halfway is that, "Steve, this is not the whole story."

And of course, it is not the whole story, because we are not currently measuring--although I suspect we'll move to measure--how much of that seven-day supply, if you will, is actually available for release. That is a complex question. Most hospitals keep track of inventory that's available for cross-match and how much is committed to a patient.

The question that we'll have to answer there, I think, from pooling experience, is whether or not that disaggregation of, say, half the supply, because it's already been cross-matched, is an appropriate measure of shortage. If there's only so much blood around, maybe there is a different way to manage it. Or if by increasing our margin from seven to ten days it creates an unbearable economic burden, maybe we'll have to look to alternatives. But our raw data here is seven to eight days.

This is an average over all sites. For the individual sites, there is a weekly period. There's more surgery done on Monday morning than there is on Sunday afternoon.

If you're looking in subsequent slides, you'll see there is a little "M." Look at the left side. You'll see the signatures of the graphs there to follow. What this means is that 14 of our 29 sites--and I put the three big ones in here--are running more than a seven-day inventory on a given day, and 14 of our sites are running less.

What I'm going to do from this slide is give you the distribution, by giving you a box plot in a minute. And I don't want to turn off those of you who are still awake when I show you our complicated slide.

What I'm going to show you in the next slide is where the 25th and 75th percentile is. Most people run between five and ten days supply. So take a deep breath, and there it is.

You will see, the spikes go to 95 percent. There are some--One site a day will run around 15 or so days' inventory. One site, not necessarily the same site, will run around two or three. But this is how the individual sites match themselves up against the median line.

These are hard, I think, simple numbers. The difference between these and what I've showed you before is that these are easier to comprehend, but I think give you less information. If you want a simple number: What is the average median day's supply? Hospitals are 7.33; the community centers are a little big. You scrunch them together, and it's 7.4 days, which was the same number that I gave you in August.

There is a little bit of variation between the groups. What does it mean right now? I'm not particularly sure. But I would point out that the community blood sites that do the collection have got a lot more "B"-negative and a lot more "A/B"-negative, the rarer types, than the hospitals do.

I want to briefly then show you where we are with individual sites. "O"-positive in our series behaves like a commodity, behaves like the total supply. You'll see it bounces up a little bit in the hospitals, and it's pretty stable through January 29th at 12:00 noon.

We're going to go to "O"-negative and "B"-negative. Just look for numbers. We have for the hospitals about 9,000 units total that we're tracking. About 3,000 of them are "O"-positive, and about 1,000 of them are "O"-negative.

Dr. Bianco was one of several who told me I ought to be watching the "O"-negative as a leading indicator of a pending shortage. And again, watch this spot here for a minute. Thank you very much. A lot of people have contributed to this already. Dr. Bianco is one of many who's contributed a lot to it.

There's a subtle decline, but I think it's clear in the back of the room that the "O"-negative has been falling in January. And when you look at "B"-negatives, we don't keep a lot of "B"-negatives in our hospitals. And again, you're looking at raw data, this jagged up and down; but "B"-negative has also apparently been tight over the last 29 or 30 days.

Here is the first of the two slides where for this project the rubber meets the road. And this is the frequency of blood shortage events by week. This is anything that anybody reported to the shortage indicator: near-miss, direct hit, not sure, free text.

There is only one week where there is a blank. And that is the week that came 42 days after September 11th, when there was a very substantial excess inventory, as indicated--and I'll show in the next slide--by the number of out-dates.

There is a base line indicator of shortages. But you will see that in December they've climbed up. We're two sites down from last week. We've only got 27 of 29 in as of Tuesday at noon when I pulled it. They're probably in by now. So it's possible that we'll have two or three more for the week of January the 19th. But it would appear that the frequency of shortages reports for January has probably peaked right now. January is when things get tight, but I'm not yet ready to predict February, because my crystal ball nor my SAS [ph] program has access to that data.

But what we were looking for is: Can we anticipate when complaints are going to go up by a lag in inventory? And it's possible that we may be getting there.

What I wanted to do with this slide was not just to confuse you, but to show you what the inventories were on the day when somebody reported in this case a near-miss. And this is actually the problem with reporting near-misses. Some people are a little bit on the low side, a little bit below the mean. But people aren't reporting near-misses when they're out of blood.

This is the day's inventory a site had when it reported that either a blood order was not completely filled, a blood order was delayed, or they had to go to an alternative supplier. The near-misses occur when we're not scraping rock bottom. The near-misses occur when the majority, about 75 percent or 80 percent, are below the base line.

But I think what we have is at least one measure of a near-miss. But the ideal measure of a near-miss is one that in fact predicts a direct hit. And here comes the limitation of this study to date. And that is that we haven't had any direct hits so far.

I don't know if that's appropriately a limitation, but since this study started we have not had a single hospital of our 29 report to us that elective surgery was delayed, elective surgery was cancelled, emergency surgery was delayed or cancelled.

That is not to say that those events have not happened in the United States; but they haven't happened in this sample. And the question is, if they haven't happened in the sample and they've happened somewhere else--Well, there's two basic explanations. One is, the sample is no good. Or the other explanation--the one which I, of course, prefer--is that there is something going on in those other hospitals that's not going on here, and the way to fix the problem is to find out what the difference is.

This is the second of the observations, which is the out-dates. And this is out-date at the hospital level, not out-date at the producer level. You can see, as predicted, about 42, 43, 44 days after September 11th, after the surge of donations, yes, there was an increase in out-dates at the hospital level. And this is an increase in cost to the hospitals, I assume, unless an angel gives the money back. And nobody's called me to say that that happens.

You can see that the hospitals really didn't work it off until about the 1st of January. So interpreting the out-dates here, we have, I think, two phenomena that are intersecting and limit the interpretation of this curve right now. One is the fall off in donations that happens on a yearly basis, and one is the correction for the increased out-dates that occurred on or after October the 24th.

Things have been tighter; or would things have gotten tighter earlier if we hadn't had that? I don't know. We just started to shine our flashlight in here. And you need more time, you need repetition, I think, before you can fully interpret these data.

I can draw even nastier graphs than Ms. Chapman can draw--or more confusing ones.

For those of you in the front of the room--to say nothing of those in the back--this is simply to show that there was not a particular pattern of out-dates following August 24th. The most common units in inventory, which are "A"-positive and "O"-positive, red and green respectively, were the ones that were out-dated. We had the capacity to look; we looked, and we didn't find anything of particular significance.

Of the last two slides that I want to show, the first one is the ratio of inventory to release of random donor platelets. And the difference between these and the previous ones, there's no white space between the two. The ratio is, for all practical purposes, one-to-one. If it's on the shelf, it's gone the next day.

And the same for the very last of the slides I will show, which is for the pheresis platelets. It is, if possible, the two curves are even tighter. I do not at this point either have a good idea of whether or not this is an adequate metric for platelets. But this is why we've got contractors, is to ask the participants first of all whether or not they think this would be an adequate way, or whether or not there's a better way to monitor the supply of platelets. I would hope that there is a better way.

Where are we going with this? We need to make this project grow. We've got some useful information. One way to grow is to grow in the direction that Ms. Chapman is leading us. We remain in discussions with Red Cross and ABC. ABC has recently put up on their website a red-yellow-green blood monitoring system. And clearly, some work needs to be done to normalize or to make their data comparable to ours. Because, again, the idea is to not predict too far away; but to predict as far in the future, even a week, as we can, if we're coming into a shortage situation.

And I think the final thing that we need to figure out is whether or not a seven-day supply is the right supply or not. Right now we're in a period where, at least with the metric we have, we haven't seen an acute shortage situation develop.

Do we have the right metrics or not? These are the ones that our contractors suggested. We're using those. But we need to go back to our contractors and ask them if, for example, the available for type and cross would be a better one, and then to look at the data in the most unbiased ways we can, compare it to other metrics, and then see if that gives us the information we need to increase the availability of the blood supply or our capacity to predict and prevent shortage situations from occurring. Thank you.

[Applause]

DR. BRECHER: All right. Thank you, Steve. Steve, do you have time for some comments or questions, if there are any?

[No Response]

DR. BRECHER: If not, we'll move to the public comment portion of the program. Anyone who has any comments, questions they'd like to make, please come to the microphone, identify themselves, and proceed. I know there are already a few who have already said they'd be coming up.

MR. CAVENAUGH: Thank you. My name is Dave Cavenaugh. I'm government relations staff for the Committee of Ten Thousand.

In early December, we were in discussions with Sieber [ph] over the recent CJD guidance, Sieber of FDA. Our comments included a recommendation that the guidance be implemented as soon as possible, not in two phases six and 12 months out. They responded the phasing was to ease recruitment pressure, as blood organizations faced new deferrals of several percent.

We counted that public and private efforts could easily increase supply above the 5 to 10 percent of eligible donors now active. We discussed schisms in the blood industry and jurisdictions of agencies.

After the call, we prepared a press release sent to 500 news outlets on 12/11 on this point. We've provided copies here today.

The situation in December needed to be addressed, as well as the one in September. Then, too, there had been a nightmare between concerning over-collection, a liberty fund, and anthrax, and government leadership questions that emerged.

We felt that a unique opportunity--if tragic--in donor recruitment had been lost. We laud the AABB for forming its taskforce, but the retrospective focus on September, troubled as it was, overlooked the unfolding situation.

We represent the HIV-infected hemophilia community, one dependent on a safe and available blood supply. Earlier today we heard the phrase "like sand slipping through our fingers." This well describes the opportunity and the blood lost.

We have seen five years of off-again, on-again shortages. We appreciate the distinction between whole blood and plasma issues, shortages in both of which leave us in a precarious situation. Chronic disease communities dependent on regular whole blood product usage need to have adequate supply mechanisms.

We were speaking with the FDA on about December 8th. And as I looked to the calendar on the wall as we talked, I saw December 11th just ahead, and noted that that would be the three-month "month-iversary" of the tragedy in New York and Washington. And it just became blindingly clear that getting a PSA on the air--with Dr. Satcher, with Mr. Thompson, with some public figure from Hollywood, whatever, sports--would be very opportune at keeping the public message going that blood is now needed again.

We had obviously gone past the 42 days, but not by too much at that point. I think that now that we're four and a half months out, that's a little harder to accomplish. And that spot, that PSA, preferably, if it had Red Cross, AABB, and ABC logos on it, would speak with one voice, which is what we were saying was missing.

Adequate supply maintenance cannot tolerate schisms. Shortages impact safety. When in shortage, government is forced to make regulatory decisions sensitive to supply. Decisions regarding safety of our blood should not be colored by questions of supply.

American has proven its willingness to donate when needed. Our community calls on government and blood organizations to speak to the public now, four and a half months after the attack, with one voice, to boost recruitment and, hopefully, avert a most dangerous situation now developing. Thank you.

DR. BRECHER: Thank you.

MS. DE SIMONE: My name is Anna De Simone. I am here today as the mother of a child with hemophilia. I serve in a volunteer capacity as the president of the Hemophilia Association of New Jersey.

I am, as you can well imagine, as concerned as anyone in this room about the safety and availability of the blood supply, and of course, of access to safe clotting factor. In our collective efforts, we must not lose sight of the fact that this committee evolved as a result of the recommendations of the Institute of Medicine. The IOM was very clear regarding conflict of interest and the role it played in the contamination of the blood supply during the 1980s.

And I quote from their report and recommendations in the executive summary:

"Financial conflicts of interest influence organizations as well as individuals. The standards for acknowledging and in some cases avoiding conflicts of interest are higher than they were 12 years ago. Public health officials, the medical professions, and private organizations must uphold this new difficult standard. Failure to do so will threaten the fabric of the trust that holds our society together."

I urge this committee to heed these wise words. Thank you.

DR. BRECHER: Thank you.

MR. BABLAK: Hi. My name is Jason Bablak, and I'm with the Immune Deficiency Foundation. And I just want to briefly highlight an issue that was brought up earlier today by Patrick Schmidt. And actually, we're going to talk about it a little bit more tomorrow in the open public comment, but I wanted to bring it up since it was brought up today. Which is the idea of a stockpile of IVIG that contains vaccinia antibodies. The IDF is very much in support of that, and we think that that would be useful for our community as well as other immune-compromised individuals.

And secondly, the supply that was shown in inventory there by Patrick, we're not sure how long that might last. We recently have surveyed our community and still find that there is some under-utilization of therapy for our patients. And as the shortage that occurred several years ago continues to pass, we expect that the product usage will go up.

And so, certainly, this would be a good time, while there still is some supply in the system, to do that kind of program. And like I said, tomorrow we're going to give a longer presentation on that. Thank you.

DR. BRECHER: Thank you.

Dr. Goldfinger.

DR. GOLDFINGER: Dennis Goldfinger, from Cedar Sinai Medical Center in Los Angeles.

I wanted to make a couple of comments about some of the discussion about frozen red blood cell inventories and stockpiles. Frozen red cells has been a pet project of mine for over 30 years. I set up the program at the NIH, and then subsequently at Cedar Sinai. And for years we had several hundred units of frozen red cells at all times. And they were Group "O" red cells that could be useful in times of emergency.

But this program now fails, and it fails both at the hospital level and in the large stockpile level for emergency use. The big problem that we have is that the blood in the freezer suddenly becomes useless and sub-standard when the Food and Drug Administration comes out with a new and required test, disease-marker test. And so suddenly, all of that blood in the freezer has not been tested for that new disease marker. And anyone here in blood banking knows the frequency and the great number of new tests that have come along over the last few years. Each time that happens, the blood is useless.

We thought, well, what we can do is keep a little tube of plasma on each of those units, so that we could test these units afterwards if a new test came along. The problem with that--and again, why this program fails--is because there are new questions that come up that we have to ask of our donors. You can't go back and retrospectively ask those questions of our donors.

And so time after time, every time you fill that freezer, within a short period of time, guaranteed--And I'm sure the FDA has some new planned changes both in testing and in questioning that make the blood supply in that freezer obsolete.

The second problem with frozen blood as it affects the large stockpiling of blood for emergencies is that we concentrate on having to buy large numbers of freezers so that we can have the stockpile. The problem is not that; the problem is getting the blood out of the freezer when you need it in a hurry. It takes about an hour to thaw and deglycerolize a unit of red cells. So if you have a couple of cell washers, you can only turn out a couple of units an hour. That's just a joke at times of serious--in a disaster, for example.

If you had 50 cell washers, the problem would be that you would never have sufficient numbers of trained personnel to run those, because they'd only have to run them maybe once every several years. And so you could never match the need for the personnel and the equipment to the need for that blood.

So sad, but true: I think that frozen red cells are going to have to represent a niche place in blood bank supply, and certainly not be available to take care of periodic shortages or large disasters when large numbers of units of blood are needed. Thank you.

DR. BRECHER: Thank you, Dennis.

Do we have any other public comments or questions? Dr. Schmidt?

DR. SCHMIDT: I see the overhead projector is gone, so I won't ask for it. But I had one other transparency I brought with me. And the topic was only mentioned in the last few minutes here, very briefly.

I addressed it sort of awkwardly by talking about our public image. And what I would show is a cartoon that appeared in the Saint Petersburg Times in November. And I'm sure there were the same type of cartoons all over the country.

And it was a large--I guess it was a person once, probably as big as Patrick Schmidt or me, only quite wide and full, going "Burp." And on one side was a bag of blood, and on the other side was a bag of money. And there was a label on there that said, "American Red Cross."

Now, there's no American Red Cross in Saint Petersburg; there's no American Red Cross in Florida. It makes the point better.

And I think the whole blood industry was tainted with a problem which is still with us. And it's going to be with us, unless we face it up and somebody talks about the facts of what happened in that era, and that we're starting all over again.

DR. BRECHER: Thank you. Are there any other comments or questions?

[No Response]

DR. BRECHER: Will we be breaking any law if we end early?

DR. NIGHTINGALE: No, but we surely will be setting a new precedent.

[Laughter]

DR. BRECHER: All right. Then this concludes today's session. We begin again tomorrow, I think at 8:00.

[Whereupon, at 4:32 p.m., this meeting held on January 31, 2002, of the Advisory Committee on Blood Safety and Availability was adjourned, to reconvene the following day, Friday, February 1, 2002, at 8:00 a.m.]

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