Blood Safety TranscriptsADVISORY 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 P A R T I C I P A N T S 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 C O N T E N T S 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 P R O C E E D I N G S 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 | 
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