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Blood Safety Transcripts

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

Tenth Meeting

Errors and Accidents in Blood Administration:

What Can Be Done to Reduce Their Occurrence?

Volume II

Thursday, January 27, 2000

Hyatt Regency Capitol Hill

400 New Jersey Avenue, N.W.

Washington, D.C. 20001

PARTICIPANTS

Arthur Caplan, Ph.D.

Stephen D. Nightingale, M.D., Executive Secretary

Larry Allen

James P. AuBuchon, M.D.

Michael P. Busch, M.D., Ph.D.

Richard J. Davey, M.D.

Ronald Gilcher, M.D.

Edward D. Gomperts, M.D.

Fernando Guerra, M.D.

William Hoots, M.D.

Dana Kuhn, Ph.D.

Karen Shoos Lipton, J.D.

Gargi Pahuja

John Penner, M.D.

Jane A. Piliavin, Ph.D.

Marian Gray Secundy, Ph.D.

John Walsh

Jerry Winkelstein, M.D.

Ex Officio Members

Mary E. Chamberland, M.D.

Jay Epstein, M.D.

Lt. Col. Fabrizio Saraceni

Paul R. McCurdy, M.D.

David Snyder, R.Ph., D.D.S.

CONTENTS

AGENDA ITEMPAGE

Old Business

Preliminary Report on Direct Notification

Programs for Possible Hepatitis C Exposure-

Miriam Alter, Ph.D., Centers for Disease

Control 5

Implementation of Blood Action Plan

Initiatives to Promote Blood Availability-

Capt. Mary Gustafson, Food and Drug

Administration 33

Canadian Responses to the Challenges Posed

by vCJD Deferral Policies - Francine Decary,

M.D., Executive Director, Hema-Quebec, and 56

Graham Sher, M.D., Vice President for Medical

Affairs, Canadian Blood Services 67

Committee Discussion --

Additional Measures to Reduce the Incidence of Transfusion Errors and Accidents

Positive Identification of Patient, Blood

Samples, and Blood Components Using the

Immucor ABS2000 and I-TRAC-Plus Bar Code

Systems - S. Gerald Sandler, M.D., Professor

of Medicine, Georgetown University 96

Adjournment xx

PROCEEDINGS

DR. CAPLAN: Good morning. What I'd like to do today is say just a little bit about the agenda. We're going to catch up on some matters that the Advisory Committee has considered before and then return back to the issue of transfusion errors and accidents and what steps might be taken to reduce the incidence.

I was impressed yesterday with the presentations that I heard and then the readings. In some ways, blood and how it deals with problems of error becomes a useful model for thinking about error more generally, so I think in that sense we can perhaps shed some light on ways to handle medical error by looking at what's happened to reduce error already and what might be done to get further down the road in the blood world.

We have a schedule that could get us out of here by 3:00, and maybe earlier if we really stick to our time on the speakers, and so I'll try to drive along the presentations. And what I wanted to say to the morning speakers is that some of the panel want to make sure there's time for talk and discussion, so if you've got a slide that you're thinking about in terms of does this have to be there or not, they'll ask you about it if they want to hear about it. So expeditiousness will be good. That will open up for more questions and comment in the morning.

So with all that, Miriam Alter, who will be familiar to many in the Advisory Committee, from CDC, is going to give us a report on what's going on with the direct notification program for hepatitis C.

DR. ALTER: Thank you. This morning I am going to present to you the preliminary analysis of progress to date on the efforts of the blood collection establishments and transfusion services to carry out the targeted notification of transfusion recipients who received blood that may have contained hepatitis C virus.

This evaluation was done by CDC in collaboration with the American Association of Blood Banks' Interorganizational Task Force on HCV lookback, in addition to the Agency for Health Care Policy and Research and the FDA.

What happened? Oh. Technology, it's a wonderful thing, isn't it? Oops.

Just to refresh your memories, targeted lookback is the identification of prior donations from repeat donors who later tested positive for HCV, notification of transfusion services to which components from these prior donations were shipped, and the identification and notification of recipients who received components. And everyone on the Advisory Committee should have a copy of these slides.

The first phase of the evaluation was intended to evaluate the effectiveness for notifying prior transfusion recipients of their potential risk and for identifying persons infected with HCV, as well as to determine the cost-effectiveness. We performed nationwide surveys by mailed questionnaire of all blood collection establishments and transfusion services in the United States.

To determine progress to date--and, remember, this is an ongoing process which is going to take several more years to complete--we mailed the first set of survey forms in mid-November to 200 blood collection establishments, representing 148 community-based blood centers, included among America's Blood Centers, the American Red Cross, and United Blood Systems, as well as 52 hospital-based blood collection--transfusion services that collect blood. And we mailed forms to 5,468 hospitals based on the American Hospital Association mailing list. Not all of these hospitals are expected to either have transfusion services or to receive notifications.

Responses were requested by December 24th. We sent follow-up postcards to remind everyone to respond to the survey, and we also called all of the blood collection establishments since the number of those was manageable in terms of telephone follow-up.

For the blood collection establishments, 72 percent of the community-based blood centers responded and 54 percent of the hospital-based. These respondents represent 81 percent of the blood collected in the United States, so we had an excellent response, and there are 56 additional responses which were not included in this interim analysis because they came in during influenza and ice storms, and we were unable to analyze them in time for this presentation.

Of these blood collection establishments, they reported to us that they identified 60,000 donors triggering lookback based on multi-antigen testing, and that from these donors, 87,000 components were shipped to transfusion services, and 67,000 required the transfusion service to be notified. There are reasons why transfusion service aren't notified. They've been closed or they've merged or they don't have records or for a variety of reasons.

Eighty-eight percent of the blood collection establishments indicated that they told their consignees that they would provide testing to recipients at no cost.

About 80 percent of the blood collection establishments are 90 percent or more complete, or have completed 90 percent or more of the notifications from multi-antigen-screened donors, bringing them close to completion for the date set by the FDA guidance as the end of March of 2000.

Only 15 percent--15 percent have completed notifications of transfusion services based on single-antigen-screened donors, but most have not begun this process.

Among the transfusion services, 48 percent responded to the survey, and there are an additional 500 responses which have been received but not included in this analysis. The respondents indicated they'd received notifications on 48,000 components, of which 85 percent were transfused to identified recipients.

Of the 41,000 recipients eligible for notification, the process has been--the notification process has been completed on 80 percent. Seventy percent were found to be deceased, and 23 percent have been successfully notified. We just considered those alive who can be notified. The transfusion services have done an excellent job of locating and notifying these individuals, 78 percent.

If we look at the outcome of the notification by the year these recipients were transfused, we find that two-thirds of the recipients for notification were transfused between 1988 and 1991, and as we expected, the proportion of those who have already died increased the further back in the notification--or the further back the transfusion occurred, so that about 70 percent of those who have been transfused more than a decade ago have already died.

Also, as we anticipated, being able to successfully notify these recipients decreases the further back the transfusion occurred, and less than 20 percent of those transfused in 1988 or before have been successfully notified. However, as pointed out before, of those found to be alive, the success rate in notifying them is quite high, although it also declines the further back the transfusion occurred.

Eighty percent of the transfusion services indicated that all of their notification letters offered testing at no cost to the recipients. Testing might be offered by either blood centers or the transfusion services themselves.

Forty percent of the transfusion services reported test results on recipients. From these transfusion services, 54 percent of the recipients had been notified--I mean, had been tested of those notified, and 28 percent of those with test results were anti-HCV-positive, half of whom knew their positive status prior to the notification.

Except for those transfused before 1988, the proportion of recipients tested did not vary substantially by the year in which they were transfused. However, the rate at which they tested anti-HCV-positive did. Note that only 8 percent of those transfused since 1993 tested positive compared to about 50 percent of those transfused before 1988.

So if we put all of this information together and look at the bottom line, we see that of all the recipients identified for notification, 70 percent are deceased, 23 percent were successfully notified, 12 percent of the original target population were tested for HCV, 2 percent of the entire population at risk was positive for HCV, of whom half knew their positive status prior to the notification. So that the effectiveness of the targeted lookback for identifying HCV-positive individuals is about 1 percent.

In summary, these interim results indicate that 80 percent of the blood centers have completed 90 percent or more of their component notifications based on multi-antigen testing. But the total components requiring notification are likely to be less than one-third of our previous estimate. The notification process has been completed by transfusion services for 80 percent of recipients of components for multi-antigen-tested donors, and remember, the transfusion services have a year after the blood centers' date of completion to complete this process. So they're quite ahead of schedule in terms of completing the multi-antigen--notification based on multi-antigen testing.

Most at-risk recipients, most individuals who need to be notified, are already deceased, and about one-quarter of the target population was successfully notified. Of the recipients who were tested, less than 30 percent were found to be HCV-positive, and of notified recipients transfused since 1993, most, 92 percent, tested HCV-negative. This is most likely because repeat donors who have been tested since 1993 were most likely previously tested and tested negative, and, therefore, the infections represent--the infections that their testing is identifying represents recent infections and their prior donations were actually not infected, so that their newly acquired infection did not put their prior recipients--or recipients of their prior donations at risk.

The effectiveness of targeted lookback for identifying HCV-positive individuals is about 1 percent, and this indicates that general notification may be as effective, if not more effective, actually, than targeted notification since half of the HCV-positive recipients identified knew they were positive prior to the notification.

DR. PENNER: Why do you say that? Why can you make the statement and say that it would be just as effective to have notified them generally as opposed to specifically?

DR. ALTER: I said they were as effective, and then I--it's possible general notification might even be more effective, because half of these individuals were tested as a result of the fact that their physicians identified them as needing to be tested.

DR. PENNER: But half were not.

DR. ALTER: That's correct. I said it was "as"--I'm sorry. I--

DR. PENNER: My impression was that you felt that general notification might have been better or as good as just not notifying them specifically, as had been done in this process.

DR. ALTER: I think it's very possible general notification might be, if we had done--general notification also implies that we had an all-out campaign to educate both the target population and their health care providers about the need to be tested, which is something that's ongoing now. And all I'm saying is that it's very possible that that approach could have accomplished the same level of effectiveness since a fairly passive approach managed to get half of these individuals tested.

DR. PENNER: Okay. An assumption.

DR. ALTER: We intend to repeat the--obviously, since this is an ongoing process, we will be repeating the national surveys to follow up on not only continuing progress but also the final outcome. The timing of these additional surveys will be dependent on the final FDA guidance, that is, the dates that they set, that the FDA sets for the blood collection establishments and transfusion services to complete the extended lookback as well as the single-antigen--lookback based on single-antigen testing. And final surveys will also collect data on the resources and costs required to complete the notification process.

Phase II of the evaluation is currently being planned and will include contacting a sample of notified transfusion recipients directly, probably by telephone to determine their reaction to the notification, their response to the notification, that is, what action they took, and which may give us a better estimate of the number of or proportion of recipients who availed themselves of testing as a result of the notification, as well as the proportion of recipients who already knew their status, and the results of that testing.

And, finally, of course, we are going forward with strengthening the general education of the public as well as health care professionals, which includes a hepatitis C public information campaign, which includes a media briefing and materials which were--took place and were developed last spring, public service announcements that have been recorded by Dr. Satcher recently and should be launched in the near future, public transit advertisements, a manned hotline which is now available seven days a week, 24 hours a day, and written educational materials developed not only by CDC but also by its voluntary health organization partners.

Professional education, as you know, has been ongoing for quite a few years, involving educational materials, Web-based training, et cetera, meetings, symposia, and also at the end of February, February 27th and 28th, we're having what we'll call a transfusion organizations meeting, which will include representatives from professional and voluntary organizations whose populations are likely to include a large proportion of transfused patients or whose physicians or nurses care for a large proportion of transfused patients, in order to develop and implement approaches for identifying patients with a history of transfusion of blood- or plasma-derived products.

Thank you.

DR. CAPLAN: Thank you, Miriam.

Let's open the floor up for questions. Jane?

DR. PILIAVIN: Two questions. What's the total number of people who were located who were indeed found to be positive, that 1 percent? How many people is that? And roughly how much did this effort cost us?

DR. ALTER: Well, the number of--we have not adjusted the number for, let's say, non-response, so that this analysis is based purely on the number of individuals reported by the facilities that have been--that were included in this particular survey.

DR. PILIAVIN: I'm just asking about--

DR. ALTER: The absolute number, I can look for it and give it to you.

DR. PILIAVIN: Yes, rough ballpark. Twenty? Fifty?

DR. ALTER: It's about--I want to say it's about--a little over 400 tested positive.

DR. PILIAVIN: Okay. And how much, roughly, was spent on this whole--

DR. ALTER: Well, we haven't--

DR. PILIAVIN: --effort, lookback effort--

DR. ALTER: We haven't measured that yet. We're not measuring that until they complete it, the process. If anyone from the industry wants to...

DR. PILIAVIN: There's various ways of measuring efficiency, is what I'm saying.

DR. ALTER: Oh, absolutely, and this is a preliminary analysis. I think that the industry has done an excellent job in going forward with this and in reaching those people who are eligible--who are still alive. And they should be congratulated for their efforts.

DR. CAPLAN: Let's put the name in.

MR. MacPHERSON: Sure. Jim MacPherson, America's Blood Centers. Several of our centers have done some cost analyses, and these are all very preliminary numbers, but probably in the order between $100 and $125 per notification. So if there is 100,000 notifications, then multiply that by $100 and that's the cost.

DR. DAVEY: I think the Red Cross roughly spent about $10 million.

DR. CAPLAN: Keith?

DR. HOOTS: Miriam, in terms of the follow-up, the next phase, when you call the people who have been notified that they have HCV, are you going to query them--and, again, I'm just trying to get at, coming full circle to the debate we started with about efficacy and value. Are you going to query them to what their perceptions were not only about being notified, but would they have likely have responded to a broader campaign in the community? Because I think that's an important question, because some people clearly do. Some people say, well, I saw it on TV and I immediately went and got tested. Other people say, I never listen to any of that kind of stuff.

I wonder if that's part of the next phase.

DR. ALTER: The next phase is still in planning, so we don't have the interview completed, but we'll certainly take that into consideration, including it.

DR. CAPLAN: Fernando?

DR. GUERRA: Yes, Miriam, it was obvious from the data that you shared with us that a very significant number of these individuals that we're trying to identify were deceased. It's obviously very difficult to get the information from the population that is deceased of what the underlying conditions were that they died from. I wonder if there's any sense of whether or not some of those perhaps were infected with hepatitis C. And the reason that I bring this up is that in looking at some of our own death data, we have over the last 10 years continued to see on an annual basis an increase of hepatitis C appearing on the death certificate as one of the conditions associated with death.

DR. ALTER: No, we have no idea. But I also think that there have been quite a few other studies showing that most of these deaths are related to their underlying condition and the reason for which they were transfused.

DR. CAPLAN: Jim?

DR. AuBUCHON: I would like to congratulate Miriam and her colleagues at CDC for conducting this analysis on quite short notice, and beginning to gather the data that really this committee or similar committees in the future will need to refer to in order to understand how to approach these kinds of questions.

With HIV the look-back question was, quote, unquote, "a no-brainer." We knew that was the appropriate thing to do, and it began long before anyone from the federal government or the community at large suggested that blood bankers should be doing it.

With HCV the questions were not so clear, and having these data such as Miriam is collecting now, will certainly be helpful for the next time we approach these kinds of issues. There are options available, and the general notification or public education approach is one that we will need to investigate more carefully as to whether or not it will be effective. The only similar approach that's reported has been from Cincinnati a decade ago now, and that response rate in the community was about 5 percent or a little bit less than 5 percent, so indeed, a public education campaign may be more effective than what we've been doing, but it may not be, and so we will need to gather that information. I appreciate that.

DR. CAPLAN: Let's go to Ron.

DR. GILCHER: Miriam, there will be an impact of those who acquired their hepatitis C through another route. Is there any way to assess that? In other words, some of these people obviously got their hepatitis C not from the transfusion but from another route, and that tends to muddy the picture.

DR. ALTER: That may very well be true. We're not going to measure that, and since the objective was to identify, you know, people who might have been infected with HCV, it accomplishes that regardless of the source of their infection. I will tell you that in our studies, in individuals who have a history of transfusion, almost never have another risk factor. So I think the majority of these individuals probably don't have other risk factors, but, as I said, we're not going to measure that.

DR. CAPLAN: Jay?

DR. EPSTEIN: Jim, I beg to differ about the historic record on HIV. FDA recommended the look-back in July 1985. However, we left it to medical discretion, and the President's Commission on the HIV Epidemic found in 1988 that only approximately 20 percent of look-backs had occurred, and this is what led President Reagan, in his 10-point response, to indicate that it should be mandated. Now, it is true that it was essentially completed by the time a regulation became finalized in 1996, but I would contend that it was neither obvious nor automatic that it required a certain amount of public dialog and government pressure.

My question for Miriam is: in looking at the effectiveness, you've measured the 1 percent effectiveness based on the target population of recipients identifiable through records. However, a different way of looking at it would be what percent of living persons who may have acquired HCV from transfusion were found through look-back. And I just wonder, now that you have modeled some of the outcome data, have you gone back to model what percent of that target population was captured by the effort, because I think that might be a better way to look at the effectiveness.

DR. ALTER: We haven't yet, but we can certainly do that.

DR. GOMPERTS: Dr. Alter, this is really an outstanding effort, and I'll look forward to the final report. Are there plans to evaluate the effectiveness of the general education program?

DR. ALTER: We hope to. It's a little more difficult, but we hope to go into various communities with campaigns and set up an evaluation at the same time to determine how effective these campaigns are in getting people to at least seek medical counseling and testing.

DR. DAVEY: Miriam, on the general notification--perhaps I missed it--could you also tell us what plans CDC has developed since we last heard from you on general notification for the 93 percent of people who got HCV from means other than transfusion?

DR. ALTER: Actually, it's quite a similar approach, just expanding all of these messages beyond the transfusion recipients, so that each of the target populations has messages targeted directly to them. We have found that trying to communicate a message doesn't work if you just have a laundry list of risk factors and say, "If you belong to any of these groups, you should get--know you're at risk for HCV and get tested" doesn't work very well. So each of the high-risk populations for whom we recommend routine testing needs to have a message tailored specifically for them, and we're working on that now, particularly the individual who might have injected drugs in the past and no longer--and does not identify themselves as such. This group represents the majority of infections today, chronic infections today.

And part of this--getting this--part of the success of these efforts is dependent upon support of counseling and testing programs in the public sector, because to give out a broad message about that all of these individuals, other risk groups should be tested, requires us to provide the resources for them or the places where these individuals can go, and that's in the planning stages in the sense that we need to have the resources to support that, but we also have several demonstration projects currently ongoing to see how best to provide those services in the public sector.

DR. CAPLAN: Dave?

DR. KUHN: And, Dr. Alter, I think compliments are in order for the CDC on carrying out an effective targeted notification for HCV infection, first of all.

And second, the question I have--and hoping I'm hearing correctly--is that approximately 100,000 persons were notified, and out of the 100,000 persons notified, approximately--well, I'm saying, I guess it would be close to 500 were--already knew their HCV-positive status, and then 500 or 400, whatever, did not know their HCV status and were--in other words, found out through this targeted look-back. Is that--am I perceiving that correctly?

DR. ALTER: Are you trying to adjust for the non-response at this point, or just--

DR. KUHN: No, just looking at--

DR. ALTER: Well, no. You've doubled the numbers essentially at this point.

DR. KUHN: Double the numbers, yeah.

DR. ALTER: Yeah, you've doubled your numbers. So I haven't tried to adjust this information to the country to account for non-response. We have no idea of the transfusion services who responded, what proportion of the transfused volume they account for, and at this point I can't--I would not be comfortable applying an absolute number to any of this, because we just have not had time to do that, to account for the non-response and other issues, so--

DR. KUHN: I guess what I would like to just suggest to the CDC, if at all possible, when the report is finalized, if there could be numbers placed into this report, as well as the cost that it acquired to do this targeted look-back.

DR. ALTER: This was done--this is the first of a group of serial surveys. This was intended to measure the progress to date. It was done as an interim. And we--the idea being that we will measure the entire effort when it's completed, and at that point we'll be able to come up with absolute numbers, and possibly prior to that, since for multi-antigen screened donors, they are very close to completion, and I would think that most likely by the end of--you know, at some point during this year we'll be able to give you absolute numbers on that. Of course, we--I fully intend to do that. And the cost will not be collected until they have completed the process.

DR. KUHN: Thank you very much.

DR. PENNER: I'd like also to commend the CDC for just an excellent and impressive response so far in achieving their goals. I think I would be concerned yet about the single antigen donors which you have not really addressed very effectively yet, and that represents perhaps a majority of those donors that originally would have been culled out of our donor population, giving rise to the second generation testing, so that they're still, I would think perhaps, even higher numbers of positive patients in that group that hasn't been looked at. And secondly, I think this means it's for those several hundred that were identified, this is 100 percent success. The ones that did not know they were--that they were positive for hepatitis C, which gives them a whole different outlook for life and how they're going to manage it. This brings us up, I think, to the level of the Canadians and United Kingdom, that we have taken the responsibility to notify these people.

DR. CAPLAN: Maybe one last question, and then we'll let Miriam go. And I don't mean to put you on the hot seat about this. It's just something that I've been watching in my own little neck of the woods about the Philadelphia Fire Department. There's been a lot of discussion about higher hepatitis C rates in EMS and firefighter workers. It's particularly an acute discussion right now in Philadelphia, but I gather it's going to be spreading out to other places. And you can't help but look at that coming from the Advisory Committee in trying to understand incidence rates from transfusion and from drug behavior in the past. But the comment here is that exposure to blood can drive much higher infection rates, and in trying to baseline out what's going on, I'm just curious how this data, the surveillance data, other things that we have shapes that debate?

DR. ALTER: I think that there is a lot of misunderstanding about the information that's been communicated about the firefighters in Philadelphia and about the risk to public safety workers or emergency response workers in general.

First of all, the prevalence of infection, which is what they were measuring when they did that survey, is probably not higher than the general population as they're implying, because they're comparing it to the overall rate of 1.8 percent in the general population, when in fact, I imagine these firefighters are mostly male, mostly between the ages of 20 and 50, and the males--I don't know what their ethnic, racial-ethnic group is--but males between those ages are more likely to have rates that are 3 to 6 percent, which in fact, would not be different than what they are saying the firefighters have. And based on studies of other health care workers who have frequent percutaneous exposures to blood, such as orthopedic, general and oral surgeons, the rate of HCV infection is actually quite low, about 1 percent.

It's my professional opinion that the firefighters--most of the firefighter's infections that have been identified are not the result of occupational exposure.

DR. CAPLAN: Okay. That's something I think we'll hear more about that down the road. But the Committee wants to thank you for the presentation, look forward to continuing updates about progress in terms of look-back.

Let's turn right away to Mary Gustafson from FDA, who is going to talk about a topic that seems to be very much in the news, plans to promote blood availability, something that at least since I walked into this room people have been haranguing me about in terms of shortages and problems in finding donors, particularly right now. So you're going to solve that for us, I assume?

CAPT GUSTAFSON: Thank you. And I'm very low-tech. I have overheads.

This is in the old business section, and so I wanted to remind you--if we could have the next overhead--that it was only 5 months ago that I came before the Committee and reported--gave the recommendations from a report entitled "Strategies for Increasing the US Blood Supply." And this was a report that was prepared by a task group under the auspices of the Inter-agency Working Group on Blood Safety and Availability, and at the request of Dr. Satcher, following the National Blood Data Resource Center's survey, comparing 1997 and 1994 blood availability data. And the survey had projected that the demand would overtake supply in the year 2000. The group convened and developed a report in five areas that was presented to Dr. Satcher in August of 1999.

Next overhead. Dr. Satcher considered the report, and the Blood Safety Committee met in November and considered the recommendations from the report, and later that month the report was adopted as an amendment to the Department's ongoing Blood Action Plan.

Next overhead. To refresh your memory, the report recommended activities in five areas. The first is to monitor the blood supply. The second, to encourage more donations by eligible donors. The third, improve donor relations as a part of recruitment and retention. Four, remove restrictions to safe donation. And five, address economic issues facing the blood industry. And I will update you--refresh your memory on these areas, and update you on the current status.

First, in the area of monitoring the blood supply--next overhead, please--the National Heart, Lung & Blood Institute, on December 10th, entered into a contract with the National Blood Donor Resource Center--Data Resource Center to conduct monthly surveys and provide data to the Public Health Service. The surveys will be conducted in 28 blood centers based on the size of the centers, and two others that were selected based on characteristics, New York Blood Center on size, and Pittsburgh on their centralized cross-match function.

The data collection started--well, we'll start with October 1999 data. The first data will be coming into the National Health, Lung and Blood Institute in early February, and there's a smaller group, the ad hoc task group--I don't know what it's called when you subdivide down that far--will be reviewing the data, but it will be reviewed on an inter-agency basis on a monthly basis.

And then by October of the year 2001 the Public Health Service will determine whether this function, the monitoring function, should become a program activity within one of the Public Health Service agencies.

The next element, activity element, is to encourage more donations by eligible donors. What has occurred so far is the Department of Health and Human Services has offered its support to the industry to participate in public service announcements. Industry representatives met with department officials before the end of the year. I think it's fair to say on this initiative the ball may be in the blood industry's court at this time, but I think Dr. Satcher has been offered to help in giving public service announcements.

The National Heart, Lung & Blood Institute is sponsoring a February 28th workshop. And I notice from Dr. Alter, this end of February is going to be a busy time. The workshop will be entitled National Strategy to Increase Blood Donations. This workshop will be fairly small, limited to around 40 to 50 participants, with presentations and focus group activities. The participants will be people who are knowledgeable in blood donation, including donor recruiters. And the goal is to come out with a unified message and unified mechanism for delivering that message to the public.

FDA has committed to publish a donor incentive guidance by June 30th, 2000. This guidance will be what is allowed right now by our regulations. Our regulations are very strict in saying what is a paid donor and what is a volunteer donor. The paid donor designation indicates that a donor receives direct cash payment or something that is readily converted to cash for the donation. So what is being developed right now falls along those lines. It won't really be a guidance to tell people whether it's a desirable practice or not a desirable practice, but what is allowable now with our current regulatory authority.

And additionally, the NHLBI will explore the feasibility of initiating studies on the development of educational programs to encourage blood donations as a civic responsibility by the end of June.

Next overhead. In the area of improving donor relations as a part of recruitment and retention, FDA has committed to draft guidance on recruitment practices by the end of this year. It's possible that FDA and NHLBI will sponsor a donor recruitment workshop by the end of August, and a decision will be made on this after the February 28th workshop to see what issues come out of that workshop that may be developed more fully in a broader public forum.

FDA is also working on guidance on computer-assisted interviews that we plan on having by the end of September, and this too will be guidance on what we have approved in the area of computer-assisted interview processes.

And there's an inter-agency industry goal of initiating a simplification and abbreviation of the donors history questionnaire by January 1st, 2001, and this will be in terms of initiating certain studies or certain ideas in this area.

Next overhead. Removing restrictions to safe blood donation, FDA has committed to issue guidance for use of therapeutic hemochromatosis donations by May 31st, 2000. This guidance is being developed based on an August 10th, 1999 memorandum from the Commissioner of Food and Drug Administration, Dr. Jane Henney, to the Surgeon General, that outlined several areas in which we would allow donors with hemochromatosis whose donations for therapeutic--to be provided as volunteer donations without restrictive labeling as to their disease state, and also to address the frequency limitations for these donors.

In the interim, we are accepting exceptions from our regulations on a case-by-case basis, and to date we have approved two of these exceptions to our regulations.

Additionally, CDC and FDA will look into having workshops in other areas of relaxing the restrictions to safe donation. We had planned for some of these workshops to be in physical year 2000 and some in 2001. Because so many of them seem to be tied with the implementation of NAT testing, most of these will probably be addressed more in the year 2001 than this year.

Next overhead. The last issue is addressing the economic issues facing the blood industry. Your August meeting was a forum for the discussion of safety measures and their cost implications. The department has also committed I think--because of the snow, I didn't get a chance to check with Dr. Nightingale--but under April meeting, to discuss further the reimbursement issues, I think particularly inpatient reimbursement issues about blood. And the department will clarify its policies on reimbursement by June 1st of this year.

Are there questions? Fernando?

DR. GUERRA: I guess the question that comes up more in the public health side of being prepared in the instance of some catastrophic event, but especially such things as chemical or biological warfare or weapons of mass destruction. The question has come up in several discussions about how well prepared is the nation's blood center operations and blood supply, you know, in terms of some of the conditions that pose a significant threat that are associated with significant bleeding diaphyses and clotting disorders that could come on very acutely. Is the supply prepared in terms of stockpiling or in terms of having an adequate volume of blood, or blood products or clotting factors that could be deployed into some of those areas of impact?

CAPT GUSTAFSON: I may need a little help on this. It's a little broader than some of our blood supply issues. I think we found in some of the natural disasters and not-so-natural disasters--and perhaps, Dr. Gilcher has had his fair share of this--that the blood industry is very able to marshal resources for an emergency and move blood fairly quickly in the US. In terms of a catastrophic incident, something like bio-terrorism, I don't know in that respect.

DR. CAPLAN: Ron?

DR. GILCHER: Yes, I can comment to that, Fernando.

Very clearly, when any kind of disaster occurs, whether it be bio-terrorism or natural, both of which have occurred within a four-year period in Oklahoma City, the response of the public is an outpouring of individuals to donate blood, so there is no problem in terms of the number of people who want to donate blood. What becomes the problem is how can one process that blood? And I would say almost all, if not all large blood centers, such as our own, have contingency plans and crisis plans in place that will allow us to process large numbers of donors, providing we're still standing, so to speak, and can really produce very large amounts of blood in very short periods of time.

The critical issue in our case, for example, going back to the bombing, was having blood on the shelf, because the reality was, the people who were acutely injured were in fact bleeding to death, and the fact that we did have the blood supply that we had is what made the difference. So for the very acute injuries it's actually the blood supply that's on the shelf, but once that passes, there's no problem in the number of people who are willing to donate. They just pour out of the woodwork, so to speak. Then the problem is can the blood center actually complete the processing?

DR. GUERRA: I guess if I could just--so we don't lose that--the concern is that, obviously, when some of these weapons of mass destruction, a cloud of anthrax spores that impacts on a population where over a period of several days, several hundred thousand people are affected with this and could not even begin to serve as donors. So that I guess the question is: is there a stockpile somewhere that could be immediately deployed into communities or regions that were affected in that way, that, you know, would have to come from outside of that area?

DR. GILCHER: Again, I'd like to comment, because there clearly was, in the case of the bombing in Oklahoma, a national response. There were people all over the country who were willing to donate, and again, I think it's the response of the general public to that kind of a problem which would occur everywhere, and so those areas that are not involved, I think there wouldn't be any problem in terms of amounts of blood that would be needed.

DR. CAPLAN: Rick?

DR. DAVEY: Yes. Just a couple other comments. I certainly second Ron's comments.

Also, we do have, as you know, at least two or three systems of national blood exchange, the National Hub and the Red Cross National Blood Exchange, that allows blood to moved around quickly in the case of a disaster. Also, there is a national consortium of 13 agencies, FBI, Defense Department, including the Red Cross, looking at nuclear, biological and chemical warfare, and trying to coordinate a national response to those particular events. We don't have all the answers, but I think certainly having the blood people involved in that discussion with the other national agencies is important.

Also, in terms of our own organization, there are increased efforts now to link the Red Cross Blood Response to the Red Cross Disaster Response, so that when hurricanes and tornadoes and other natural events occur, that the blood side of the organization is quickly and effectively wedded in with the disaster side, so there is progress, but there's a long way to go, Fernando.

DR. EPSTEIN: There is a FEMA plan for emergencies requiring increased blood use. The determination by FEMA was that the existing mechanisms in the private sector were, "A", adequate, and "B", the right place to try to manage it, rather than having it centralized to the federal government. And the response modalities are as Rick described.

I would say that the issue of having preparedness for potential bio-terrorism is somewhat newly recognized, and that the Congress has seen fit to target funds specifically for that in this year's budget, and that we can look forward to increased activity to try to figure out what the needs really are and what has to be produced. So we're not there yet, but the issue is definitely in front of us.

DR. CAPLAN: Jim?

DR. AuBUCHON: The ability of the blood supply system in this country to respond to a disaster in any particular area of the country will be dependent to some degree on the timing of that disaster or timing of the unexpected blood need. For example, if it were to occur today, clearly, blood centers from across the country could still send blood to Oklahoma City to help out if Oklahoma City needed a lot of it at the moment. That would, however, certainly have an impact on blood supply that's available for use throughout the country because of the current severe shortage of blood.

This morning, for example, I was speaking with Dr. Sandler of Georgetown before the meeting, and he noted that he had committed all of his O-negatives this morning. He has no O-negatives in his transfusion service refrigerator at Georgetown University at the moment. And that kind of severe shortage is one that would obviously impact the ability of the entire system to respond to a particular need, and if we had to move blood, there would be cancellations of surgeries and so forth in other parts of the country. We, obviously, hope that that does not happen. We hope that we would always be able to respond to a disaster as we have in the past, but our ability to do it would depend on the status of the supply at the moment.

DR. HOOTS: Just to follow up what you were talking about, Jim, and this is, I guess, for all the people with expertise, did we learn anything--we were lucky I guess that first of all Y2K didn't turn out to be a disaster, but it did teach us a little bit about what the impact of just extreme preparations could be on something like the blood supply, particularly when a confluence of events of being the holidays in addition, that create the present situation, or helped contribute to the present situation. Had there been a national or a major catastrophe like Oklahoma City had occurred on the 3rd of January, would it have essentially stopped a lot of--I mean, clearly, surgery was already put off--and if there was that possibility that things would have stopped in a whole region of the country for the next week or two in response, did we learn anything about how--other than to increase donations--how to deal with unexpected confluence of events, kind of like the error addition situation we heard about yesterday?

DR. DAVEY: I can maybe respond to that. I think we are learning a lot, and every time we have a situation like the current one, I think it's a learning opportunity, and the current situation is one of the most serious I think we've faced in quite a while. We have a confluence of the January traditional shortage along with influenza, which has dramatically impacted some blood drives, and now the storm, which has cost our system 10,000 units in the past two days, and problems like Jerry's having at Georgetown are happening around the country, surgeries being cancelled in a number of cities, and that is not good.

So in spite of, I think, the efforts that all of the blood centers and others have used to increase donations, we are very marginal, and I think this is a lesson for us, that we do have a marginal system, the UK deferral is coming, and we need to do what we can to work with Mary, the others, to do what we can to increase donations and find ways to get more donors in there, because we have a marginal supply and the current situation emphasizes that.

DR. CAPLAN: Let me jump in there. One of the things that I've had the opportunity to do just as chair, is to flag the marginal nature of the supply system in the media, and I was a little bit bothered about the fact that Mary seemed to suggest that there hadn't been a response yet to offers to give more publicity or highlight through PSAs or campaigns the shortage problems in terms of taking advantage of Dr. Satcher or others.

Related to that, I'd just be interested in hearing an opinion or two about whether the FDA role, in terms of guidance about incentives, other attempts to standardize or push through efforts on the policy side to facilitate donation is adequate. I mean, in a sense we're watching one type of response, but sufficient, not sufficient, we're impressed, we don't like it, got to do more?

DR. NIGHTINGALE: May I comment on that?

DR. CAPLAN: Of course.

DR. NIGHTINGALE: As a matter of fact--excuse me, Dr. Piliavin--the offer of the Surgeon General and senior department officials is ongoing and based on the premise that the department and the government as a whole wishes to support on a continuous rather than on a single-moment basis, the efforts of the blood industry, and to follow the lead of the blood industry.

One specific comment I would make before I turn the microphone over to the next speaker, Dr. Piliavin, is that the Department of the Surgeon General does understand that although the Surgeon General's presence, or the presence of his head on the television screen talking, might motivate some people to donate the presence of other heads, such as popular actresses from popular television series might be a more effective motivator, and the Surgeon General understand that, and will--

DR. CAPLAN: So he proposes to wear a disguise when he--

[Laughter.]

DR. NIGHTINGALE: No, the Surgeon General does not.

[Laughter.]

DR. CAPLAN: Jane.

DR. PILIAVIN: I just want to go on record--and this is based on my years of research on donor motivation--to discourage extraordinary use of incentives. First of all, there is always the safety problem that may, theoretically, be associated with the use of incentives. I would like to point out we've done lots of things recently regarding theoretical risks, most of all the "Mad Cow Disease" business. So the fact that incentives have not been clearly demonstrated to pose a risk--although there is evidence from REDS that they do--should not be used to relax the use of incentives. That's number one.

Number two, what I can speak to more definitively from my research, is that the use of incentives is very likely to undermine the internal motivations developed over time among regular blood donors.

I couldn't say this more strongly. What you end up with when you try a major incentive program is you get a temporary spike of more people giving, and then you end up having fewer people giving than you had before. There's good evidence for this, and I strongly urge that we not say, well, just go on ahead, give people raffle tickets and chances on vacations and all of those things that have indeed been attempted in the past. They don't work, and in fact, they boomerang.

DR. PENNER: I'd agree with Jane. I think our experience in local community levels has been very similar, but incentives do not add a great deal, but very briefly.

The one thing that hasn't been mentioned I'd like to bring up, and that is, has there been any chance to bring industry into this and get them involved, particularly because release time for labor to donate has been a major issue, at least in the state of Michigan, and has impacted us directly whenever this inability to get at the labor population has been presented, because there is no release time from their work.

CAPT GUSTAFSON: All of the efforts will be not only interagency, but also working with industry. The workshops primarily pull in industry participants, consumer participants, as well as agency participation.

LT COL SARACENI: Lieutenant Colonel Saraceni from the Armed Services.

One of the efforts to educate the public would go with what Dr. Gilcher said, not so much to get the people to donate because people do come out to donate when they are at crisis, but to educate, that takes time to process those units of blood, and that the effort to go into processing does take time. So the populous needs to come out on a regular basis to donate, not just in times of crisis because the blood may not be there.

DR. DAVEY: Just one kind of bit of information for the committee to keep in mind in terms of increasing awareness of the blood supply. April 7th this year is World Health Day. I am sure most of you know that. World Health Day has been designated every year by the World Health Organization as a day of the year to focus on a specific health issue internationally.

This year, the World Health Organization has identified blood safety as the international issue that they are focussing on, and there is an effort here in the United States, not entirely coordinated, to really have special activities on that day to emphasize that "Safe Blood Starts With Me." I think that is the international slogan for this. There are going to be activities around the country on that day, and it is going to be an important day for all of us to focus on the blood supply, the safe blood supply, the importance to donate.

I think the fact that the international community at the highest levels has identified this is an important signal to us, also.

DR. CAPLAN: Just a quick follow-up actually for you. What is the connection now in terms of links not just to industry, but to the religious community in terms of motivating people to donate? Is there systematic ties going on between the blood donation side and religious organizations? Is there going to be a plea from the pulpit April 7th or that week?

DR. DAVEY: I am sure that I can speak for my colleagues that we work very closely with religious organizations.

For instance, in Utah, there is a very, very clear link with the Mormon group to work with them in increasing donations.

I am not sure. Maybe some of my other colleagues would like to comment. It is mostly, I think, local regions working very closely with local religious leaders. For sure, church drives are a big part of our efforts.

DR. CAPLAN: I just meant to coordinate in the same way. If you are going to do those events, that might be one of those "here comes the Governor, here comes the Surgeon General, and here comes the local religious community." That may be a time to mount something more systematic than maybe has been tried before.

Thank you, Mary.

Let's go to our next presentation. We are going to hear about the Canadian experience in trying to deal with Jakob-Creutzfeldt disease and deferral policies in that area.

Francine?

DR. DECARY: Thank you, Dr. Nightingale for inviting me here.

Dr. Graham Sher from the Canadian Blood Services will talk just after me, and we thought it would be better if we together took all your questions.

Steve has asked us to talk about the impact of the implementation of the exclusion criteria for variant Creutzfeldt-Jakob disease in Canada, and I am going to talk about Hema-Quebec which is the blood supply for the Province of Quebec.

May I have the next one?

Perhaps before we go into this, I think it probably is worthwhile remembering that in Canada, we are still in the post-Krever era in terms of safety, and when Justice Krever issued his report in the fall of 1997 with 50 recommendations, the second one was about the principles that would guide the new blood system in Canada and the number-two principle was that the safety would be paramount.

One of the parts of that paragraph said the following, "Preventive action should be taken when there is evidence that a potentially disease-causing agent is or may be bloodborne even when there is no evidence the recipients have been affected. If harm can occur, it should be assumed that it will occur, and if there are no measures that will entirely prevent the harm, measures that may only partially prevent transmission should be taken." This is really sort of the basis onto which decisions have evolved in Canada with regards to variant CJD.

May I have the next one?

So, right from the start, there was something that became quite evident. There was no scientific proof that variant CJD could be transmitted by blood. So, therefore, the risk was impossible to assess, thus the notion of theoretical risk, but on the other hand, we knew that it was something that was quite clear that we could measure the risk to the blood supply itself.

There were two concepts that have helped us make a decision. The first one was that the shortage of blood is a definite risk, and we all assumed that we could not take a sudden reduction higher than 5 percent. If lower than 5 percent, everybody probably would be able to deal with that more rapidly.

The second thing was that if variant CJD behaves as a viral disease, then perhaps we could apply the present-time exposure concept, and then a certain reduction in variant CJD would be possible, of course, once again under the assumption that it is transmissible.

The next one.

So the first thing that we had to know, because we did not have that in our questionnaire, we had to go and do a survey of our blood donors to have an idea of what the impact would be of excluding people and deferring people who had traveled to the U.K.

The first week of January of last year, we did a systematic survey of all blood donor clinics over a period of one week. It was a one-page questionnaire, self-administered, and a multiple choice. The questionnaire was completed immediately before or after donation. The questionnaires were anonymous and voluntary, and they were performed by the two blood agencies in Canada, CBS and Hema-Quebec.

Just to give you an idea of the Hema-Quebec's operation, we operate strictly in the Province of Quebec. The annual number of donations in 1997 were approximately 212,000. We now know as of last year that there were around 230,000. Once again, the survey was done between January 25 and 30 last year.

We registered 5,500. There were 5,513 people that were registered in these clinics, and 81 percent or 4,454 responded.

Next one.

So, basically, it was a matter of knowing whether they had or not traveled to the U.K., and for the sake of getting more information at the same time, France had been added.

Just to give you an idea of the way that the responders were split, there was a little bit over-representation of the people in the age bracket of 18 to 29, and upon looking at this, it was a week where we had been into universities quite a lot.

Sixteen percent were referred donation, and 83 or 84 percent were just regular donors, which is our regular ratio.

Then, of course, the most important part was since 1980, if you traveled to, and then we had England or Wales. We had Ireland, Scotland, and then United Kingdom in general. So, if you see that in general 13.2 percent of our donors had been once to the United Kingdom, be it England, as you see most people go there, very few to Ireland and a little bit more to Scotland.

Of course, you could see here that 25 percent of our people had gone to France, and I think it comes to no surprise for anybody, since Quebec is the French-speaking enclave in North America. Of course, so any BSC country, be it France or Portugal, and we had Switzerland there, it was 32 percent of donors who had traveled there.

There was also a question of the community of time that hey had spent in the U.K. In our donors, .6 percent had spent more than one year; .9 percent more than 6 months; and, of course, 13 percent one day or more.

Then we made a little calculation in the reduction in total person-time exposure, if deferral is more than a year, more than 6 months, and more than a month, and you can see, of course, it increases as you reduce the exposure.

May I have the next slide?

One of the things that was decided in Quebec, because of what we saw, of about 3 percent of people had traveled to the U.K., we decided to go for a deferral of a month or less. So we see that a month in the U.K., there were 3 percent, that only 3 percent of the people who had traveled more than a month cumulative to the U.K. So we looked at our donor base, and we said that would mean 9,750 donors.

We have calculated over the years that most of the donors give about 1.6 times a year. So, in theory, we would have an impact of over a year of 15,600 donations. Of course, one has to find a way of replacing them.

So I think it is always important to go back to the demography of the territory that you service. The population in Quebec is about 7.4 million, and the donor population between 18 and 70 is about 5.4 million. Since we have an active donor list of 6 percent, that means that only 4.3 percent of the population basically give blood.

So, in some ways, the good news is that there is 5 million to go and look for, and if you take that only 3 percent of these have been to the U.K., there is still an enormous amount of person to go and tap in. Of course, we are still working to a mean donation of 1.6, and you can calculate it. If everybody starts giving twice a year, then you have plenty of blood.

So, in order to be able to meet that new deferral criteria, we looked at the recruitment strategy. Of course, we thought perhaps new donors, but the best one certainly would be regular donors. So we use what the people in marketing use. They use two strategies, the push strategy and the pull strategy. The push strategy is really once the person is there, you make sure that everything is correct for them. So, for example, improving the blood donation time was one aspect.

Being there more often, a lot of surveys have told us that people will give blood more often if we were there. So one of the things was increasing the number of blood drives and also implementing what we call mini mobiles.

Then the pull strategy is composed of daily recruitment, a very active one, and meeting with volunteers. We had created about a year ago a Blood Volunteers Association, which has turned out to be very helpful in discussing the new criteria, for example, and mobilizing the community to come and give blood.

Thirdly is publicity. We have moved from public service announcements to paid publicity so that you can manage exactly when, especially on TV, you want to have your publicity.

As an example, last year we invested 800,000 Canadian dollars, which is not much. You can negotiate with media, be it television or radio or newspaper, and you can get a lot more exposure time than for that money. So, as you see, it is almost a 3-for-1 sort of exposure that you get for the same amount of money.

This is a strategy that we have been using since '98, and you can see that when we compared the number of donations in the same period of October of March 1997 to 1998 and 1998 to 1999, we showed that the push-pull strategy worked since we had an increase of 4.5 percent of the donors.

May I have the next one?

So what is the impact of the donor deferral? I should say that our regulator, the Bureau of Biologics, has asked us to implement this in August, and CBS and ourselves decided to implement that on the 30th of September of 1999. So we have now 3 months into this, remembering that in Quebec if you have been to the U.K. more than one month, you were deferred.

As you see, in October, November, and December, we have had 75,000 donors of which only 533, that is, 0.7 percent, were deferred for traveling more than a month.

It is quite interesting to see this. Our explanation for this, because we had seen in the survey that it was supposed to be 3 percent, we are quite convinced, although we have nothing to really prove that, that there is a lot of self-deferral that has happened.

One of the things that has happened in the environment is that in August, when the Bureau of Biologics announced that it was coming with a directive over variant CJD, we had a lot of phone calls in the centers asking, "Well, I have been to the U.K.," this and that, and what I have learned from this is that the community is quite aware of the safety of the blood supply, and people will make their own self-deferral and not even come in the clinic.

So the other explanation would be that there was a real bias in the week of January when we did our survey last year, and in fact, these were the real numbers. It is only a 3-month thing.

Just as a matter of comparison, I went back to October, November, and December of last year. Finally, I could sort of recognize that in fact we have had more donors during this period. So the strategy that we have been using during this period--it so happens also that it is the period just before the holidays--is that we increased the number of mobiles and we went in the places where we used to go on a regular basis, but not often, in order to get regular donors.

The second thing was that we increased the publicity, and the media weight was very important since by our surveys we know that 70 percent of the people have heard about blood donation through TV.

Perhaps just as a last comment, the strategy for marketing and for publicity is to come back to the basics; that is, people give blood for a recipient, not for an organization or not for anybody. It is for a recipient. So the marketing and the publicity strategy deals around showing recipients, and we have been using children who are actually receiving blood in the last 2 years and it has been quite effective.

Thank you.

DR. SHER: Thank you, Mr. Chairman, Dr. Nightingale, and the committee for the invitation.

As Francine said, I will share with you the experience from Canadian Blood Services, and I will not reiterate much of what Francine has said.

Again, the directive was issued in Canada on August the 17th, and giving us 6 months to implement the deferral criterion, but as Francine indicated, we planned to implement by September the 30th of last year and I will show you why that is the case for CBS.

We did a similar survey to the one that Dr. Decary mentioned. In fact, it was an identical one. Just a week later, 14 whole blood centers and 2 plasma centers that CBS operates, we surveyed around 12,000 donors with a slightly lower response rate.

I will move through the numbers fairly quickly, but if you look at the right-hand column, you can see in the CBS service that we are responsible for just under 22 percent of donors would have had travel exposure to the United Kingdom from our total donor base.

For France, it was about 15 percent of our donor base and total exposure to any of the BSC countries for which we surveyed was around 31 percent.

As a function of the time donors had spent, the left-hand column is have you ever been there. That is the 22 percent for the United Kingdom, and for a total exposure of 6 months or greater was 2.5 percent of the CBS donor base.

We had enormous geographic variation across the country which is not dissimilar to the results that were found in the survey done by Adam Williams in the U.S. The numbers are very small on this slide. Suffice it to say that the variation was as high as over 4 percent of the donors from our Toronto blood center and as low as .2 or .3 percent in some of the more rural Northern Canadian areas where we collect blood. So we saw a very wide geographic variation with the national average of around 2.5 percent of our donor base.

The directive from our regulator in essence said to defer all those people that spent 6 months or greater in the countries listed on the slide here, England, Scotland, Wales, Northern Island, the Isle of Man, and Channel Islands, between 1980 and 1996, which is very similar to the directive from the FDA.

At the time that this was being discussed, CBS launched a multitude of activities to mitigate against the donor loss, and I am going to walk you through some of the activities and the outcomes of those.

What we did conduct at the time that the directive was being prepared was a series of focus groups right across the country, and we had focus groups in every city in which we have blood centers.

One of the things that became very clear from the focus groups, and several thousand donors were group-tested across the country, was an extreme disconcern on the part of both the public as well as donors who were in the focus group that if we were to delay the implementation, it did not make sense to the public that if the directive was coming out on August the 17th, why we would take 6 months to do it.

We spent a great deal of time explaining the balance between a theoretical risk and the need to protect the supply, but the overall concern was very markedly in favor.

If you are telling us that there is potentially something that may be a threat, then do something now to minimize that. I think that refers to the post-Krever era that Dr. Decary mentioned that in Canada there certainly is the desire to do something even if it only partially reduces a potential threat, but that was a very clear message in all the focus group testing that we undertook.

There was also some concern around the 6-month exposure, how much risk would we actually be reducing if there really was a risk, and a number of people in the focus groups asked us if we were simply doing this as a PR exercise to make the blood operator look good.

Many, many people in the focus groups urged regular review of this interim policy, and while they understood that there might be needs to act now, that they urged us and the regulator in Canada to look at this on a regular basis at least annually.

CBS also undertook to do an extensive mail-out campaign. We have about 400,000 active donors in our donor base, but we have a total donor base of around 1.3 million donors that have been in the donor base over the last number of years, many of whom have lapsed.

In essence, we mailed out 1.3 million letters across the nine provinces and three territories that we are responsible for in Canada. It was a one-page letter signed by our CEO that explained in layman's language the evolution of the policy, the regulatory framework for the decision, and the implementation date of September the 30th.

It was made very clear, again, in layman's language, that we were acting in a proportionary principle, and that we were really making a decision that required us to balance the risk against the supply.

We dedicated a 1-800 number across the country to elicit donor questions and concerns. I cannot remember the exact number, but it is several thousand calls to that 1-800 number since the mail-out of this letter, and, of course, most of the calls were in the first few weeks around this campaign.

Part of the letter urged lapsed donors to return if they were otherwise eligible and would not be deferred based on the 6-month travel to the United Kingdom.

We had planned additional clinics. Many clinics were increased across the country in both locations and numbers. We began purchasing some new clinic site locations or leasing new clinic site locations, and we undertook a fairly extensive geodemographic mapping of our areas where we were collecting donors from.

One thing we did do was--and this is similar to what we heard from Captain Gustafson--is we met with the regulator, with the BBR, to look at which donor deferral policies that were currently in place could potentially be lifted without imposing any safety risk to the supply, and we felt that this was an opportune time to review some of the existing donor deferral criteria.

We met with the regulator to discuss these, and four main areas were identified as potential quick hits, if you want. One of the ones that was already in the mill at the time was we had been deferring donors on antihypotensive therapy, and the age limit in Canada is only to the seventy-first birthday for regular donors and up to the sixty-sixth birthday for all first-time donors.

In Canada, hemochromatotic individuals are permitted to donate, provided they do not have cardiac or diabetic complications, but they are only permitted to donate every 56 days and we discussed ways of increasing the frequency of that. We also talked with the regulator about possibly modifying the hemoglobin level around which donors are accepted.

The regulator gave us a very clear thumbs up that at least for the first three, they would entertain submissions to lift these and other criteria. For example, we are currently deferring donors if they have had dental work in the past 72 hours, and we have just submitted to the regulator now to change that to the day of donation.

When we looked at our deferral criteria right across the system over many years, you can see that in the last 2 years, '97 and '98, we had been deferring between 13 and 15 percent of donors for a variety of medical and obviously permanent TD deferral reasons. Clearly, we needed to try to reduce that deferral rate where possible without adding risk to the blood supply. In fact, we have now, as I say, been given permission to drop the antihypotensive criterion, and that is not an inconsequential number of donors.

The environment in which the policy was implemented in Canada is an important one. As I say, we launched a very large media campaign, the largest ever media campaign for donations in Canada. We increased our donor recruitment activities, and we began to make operational changes to the way we were collecting blood.

It is also important to remember that CBS, as well as Hema-Quebec, was only established in September 1998, out of the rubble heap of the Canadian Red Cross, and many of these activities had been planned for the first 3 years of our existence, which was clearly our mandate to increase donations.

What really came to bear with the variant CJD policy was the need to severely compress the time period in which these multiple activities were going to occur. It is not that there was 70 new activities, but we needed to expedite the process as rapidly as possible.

It is also important to point out that at the same time in essence, Canada implemented universal prestorage leuko-reduction of red cells. We had been leuko-reducing our random donor platelets for over a year already, and that was implemented in the summer of '99.

That testing, we were a little bit later than the United States, but it was implemented across Canada on October the 25th. So, in essence, that program was going on at exactly the same time as the variant CJD policy. We were all facing the same Y2K issues, and CBS is currently undergoing a rather large organizational transformation project looking at the entire structure of the business and the service delivery model.

Briefly, to show you the results since the policy went in, in Canada, this is not dissimilar from the results that Dr. Decary just showed you. We had expected from our survey to defer about 2.5 percent of our donors on a national average, and you can see at least for the last 3 months of last year that we deferred about 1.4 percent in October and about .7, .8 percent in November and December. For the first 2-1/2 weeks of January, it was in fact done at about .4 percent.

We had done a validation survey after the initial one in February, and in fact, that confirmed that the 2.5 percent was spot-on when we did much more extensive validation surveys afterwards. So we feel that we knew what we expected to defer, and I think that supports the notion that many, many donors are self-deferring before coming into clinic. We currently have planned a study to contact donors who have not presented on clinics in fact to verify that the self-deferral is occurring.

As I said, the number of clinics have begun to increase nationally. These are data of the next two or three slides comparing a month of a month for the years 1998 to 1999, and as you can see in September and November, we had substantially higher clinics than we had in the previous year.

We are seeing an increase in new donors, particularly in November. In fact, the preliminary data for December show that we are seeing considerably more first-time donors than we were seeing in previous years as a percentage of our total donors.

As I mentioned, the mail-out campaign and the advertising campaign did target lapsed donors specifically. We were trying to get back into the system donors who had not donated in the previous 2 years or more, which we are defining as lapsed donors or returned donors, and you can see that we are seeing many of these donors return as well, both in October and November. We are seeing a considerable increase in the number of lapsed donors coming back to the system.

Part of the media campaign, one of the three big media campaigns is targeted at the young donors, and we are seeing hopefully what will continue as a trend to increase in new first-time young donors who hopefully, once they pass all of the screening tests, will remain in the system for a longer period of time.

This is obviously preliminary data. We only have 3 or 4 months of experience, but it is exactly the same as Francine mentioned. You can see on the yellow line our collections for the fiscal year 1999-2000, and if you look at September, the media campaign began in late August. The deferral went in, in September, and you can see that at least for September, November, and December, our collections are the highest they have ever been, month over month, for the past 3 years.

So we are encouraged by this preliminary data for the first 2 weeks of January that suggests that the yellow line will still stay above the pink and the blue line, and obviously, it is important to monitor this on a long-term basis.

So, in summary, then, we had expected to defer about 2.5 percent of our donors with a wide geographic range. We made a policy decision to implement the deferral policy within 6 weeks of its announcement by the regulator, as we did along with Hema-Quebec, and that was done coincidentally with multiple other large initiatives.

CBS undertook the largest-ever marketing campaign for donors, a campaign known as "If You Knew, Would You?" That is showing right across the country. Thus far, we are seeing much less than half the predicted deferrals, suggesting a very large element of self-deferral. We feel that so far the campaign goals are being met with overall collections up, in fact the highest they have ever been in the previous 3 years, suggesting that we had some ability to stress the system, not at an inconsequential cost, I must add. However, the issue is always how much further room is there for elasticity should similar deferral criteria go into place.

Thank you, Mr. Chairman.

DR. CAPLAN: Let's go right to questions for either speaker.

DR. PENNER: Just a question. With the changes in the management of the TSE problems in Great Britain, do you presume that there will be some alteration in your restrictions in the future with respect to travel to England?

DR. SHER: Certainly, we would review that on a regular basis, and as more data and more policy evolves, it may very well be changes. It is clearly an interim policy.

DR. CAPLAN: Jay?

DR. EPSTEIN: It is interesting that Hema-Quebec chose a deferral of one month or greater. CBC and the U.S. policy is 6 months or greater. However, I believe that the former speaker noted that the percent of exposure days captured was estimated to be 87 percent, which is the identical figure in the U.S. I just wonder whether you have estimated the percent of exposure days captured by the 6-month-or-greater deferral in CBC.

DR. SHER: We have, Jay. I cannot remember the exact numbers, but it was almost identical as well. The curves coming out of our data and those from Hema-Quebec are almost mirror images.

DR. EPSTEIN: I think the important point is that even though different deferral periods were chosen, the underlying concept of capturing approximately 90 percent, that is to say, one log risk reduction was in common.

DR. SHER: Yes. I think ours is about 83 percent or something, almost identical.

DR. DAVEY: Graham, first, let me congratulate you and Dr. Decary for juste an excellent effort at meeting this problem and providing these important data to us.

Have you been able to tease out a little bit of the cost of the mailing and the media campaign? Obviously, you made a major effort, both of you, to address this problem. Any idea how much this costs?

DR. SHER: Our media campaign alone was a $2.5-million media campaign. The mail-out alone was about a million dollars. To send out 1.3 million letters through Canada Post, it costs about a million dollars. So those two aspects alone were $3.5 million.

The other aspects of increasing clinics and increasing autologous donations and all those other things were part of what CBS has budgeted for donor recruitment over the next 3 years. We have seen the need to shift a lot of that up, but just those two elements alone was 3- or $4 million and much else spent. This is many millions of dollars.

DR. DECARY: Perhaps I could add, the marketing campaign cost approximately the same price this year, but in any case, this was October and we had planned to have our media campaign for the holidays. So, basically, it was already budgeted.

We had estimated that to go and get about 15,000 or 16,000 donations more, it would cost approximately a million dollars. That was our figure. Unfortunately, I have not looked so far how much it has really cost.

DR. BUSCH: I was fortunate to participate in the consensus conference recently, and during that discussion, we hear comments about the financing of the Canadian Blood Agency and Hema-Quebec, and I think what I heard is sort of the honeymoon, post-Krever period, you actually increased nearly three-fold the budget that was supporting the blood programs. There is an enormous amount of resource in Canada right now to support this endeavor and the others you alluded to.

This letter approach, I was proposing within our own system. It not only allows you to preclude that these people coming in who would then be deferred and all the complications inherent in that and use it as a recruitment tool, but it also prevents the deferral of these donors in your computer system. They need to proactively reinstate them.

It also lets you in a perhaps more comfortable environment, to reassure the donors who are going to be deferred that this is really not a problem for their own health.

Unfortunately, the budget within our own system would have been over $100,000 to send these letters out which seemed to make sense to me, but this is at a time when we are laying off people and our blood supply is inadequate, and whatever resources we have are trying to go into recruitment. So I think there is a real problem right now in the States.

We simply will not be able to support anything close to this without some mechanic to fund it.

DR. SHER: I think it is a very important point. There is no doubt that we are in a honeymoon period, and there was additional funding in the system compared to what the previous operator had. We might not have spent the million dollars on a mail-out campaign if this issue did not arrive, but we were able to do that with the support of our funders and I think it probably paid dividends for the reasons you state.

DR. DECARY: Perhaps I could add something. We had decided in Hema-Quebec not to do a letter campaign, but we decided to go and to use our Volunteer Donor Association. They are already organizing two little chapters. So we met with the board of directors of this association of volunteers and we had a full presentation, a little bit like what we did in terms of what the environment was, why we had made this decision.

We asked them to convey the message in the community. So at least that part for us was not as expensive as sending a letter.

DR. KUHN: Dr. Decary and Dr. Sher, I want to thank you fro that information and those statistic on donor deferral and how much you did with the Canadian dollars. I think you have to be complimented on that.

But could you say that your proactive CJD donor deferral policy complemented with your program to increase supply has not had significant impact upon your blood supply? Could you say that as these two programs have complemented each other?

DR. SHER: It is very hard to say. It is really hard to say if we had not had that deferral policy, would that yellow line had been even higher than the other two lines, even lower. It is very hard to tease out what is the exact contributor because these multiple donor recruitment and retention strategies went into place more or less at the time.

Many of them had been planned, but were compressed in time. I think it is very hard to tease out. I think it is an important question. I am not sure we know exactly.

DR. DECARY: I agree.

MR. MacPHERSON: Jim MacPherson.

I think it is important to put the Canadian experience in context, too. For almost 4 or 5 years, there had been a very public war between the government and the previous carrier, the Red Cross, with the resolution of the formation of Hema-Quebec and CBS.

My understanding is your donations nationwide at least had dropped by somewhere around 20 to 30 percent during that period of time. So they are rebuilding their whole national system at a time when they are trying to do all this other stuff at the same time.

Contrast that in the United States where donations in the United States have been increasing by about 1 or 2 percent a year, at least on the independent side for the last 5 or 6 years, and have been increased even more in the last year as demand has been increasing again.

So it is kind of hard to make the leap from where they have been and where they are now and where they are going, and I think it is remarkable that having to do all these things and having to have these all on deferrals that they are still building, but they started at a pretty low point.

DR. CAPLAN: I am going to take two more comments for the speakers, and then I actually have a resolution I would like us to think about before the break which I think we might be able to ram through.

Keith and then Mary.

DR. HOOTS: I am interested in the strategies you used to attract the younger donor population. Do you have a sense yet? Was it the PSA avenue or was it putting more donor locations in college campuses? Which one of those have you looked at as most effective in achieving that?

DR. SHER: Actually, that is one we have done a little bit of work on, and we think that the media campaign targeted at youth had a very substantial contribution to that because it was a very targeted campaign on all the youth channels on television, in the movie houses. In follow-up work by the media consultants, it is clear that in the focus groups coming out of that campaign that that is where some of those youth donors are coming.

DR. CHAMBERLAND: I guess my question was somewhat similar, which is you have seen increases not only among the young, but kind of across the board. I was curious. Are either one of you systematically surveying your donors to try and assess what it is that brought them back to donate? Because that would be very valuable information because a lot of resources--what is it that really worked?

DR. SHER: We have designed a number of those surveys that are currently underway. I think we need a length of time, but I think those are very important questions. We need to know what investment ultimately paid off. So, yes, we are doing that.

DR. DECARY: Yes, same here. We have not had a chance to do that, but your question is really important, why are people coming back.

DR. CAPLAN: Thank you.

Who on the committee has visited the committee's web site?

[Show of hands.]

DR. CAPLAN: Who on the committee can visit any web site?

[Show of hands.]

DR. CAPLAN: Okay. Well, if you were to visit the web site, as I once in a while do, you would find a lot of transcripts from this group, and they are there and available, but one thing that is not there yet is a summary of key recommendations that we have made in certain areas and a little bit of a progress or uptick about what has gone on since we made the recommendations.

So the resolution I am looking for is I would like this group, even if they cannot get there--first, you should go there--resolve that in your own minds, but, secondly, to ask staff to create on the web site a list of key recommendations that we have made in a format that will allow anyone who cares to go there to see what progress has been made or what we found out about the implementation of key recommendations.

It is not quite user friendly. There is a lot of information there, but it is not quite in shape, and I have a feeling if we push a little bit, we can get it done better.

DR. PILIAVIN: Are you asking for a motion?

DR. CAPLAN: I don't even know what that resolution was, but--

DR. PILIAVIN: I am going to put a qualification on my motion. The qualification is that you publish to the committee what the web site is. I had never been given a URL for this web site.

With that qual, I will move your motion.

DR. CAPLAN: Steve?

DR. NIGHTINGALE: First, for the record, as well as for Dr. Piliavin, www.dhhs.gov/partner/Blood Safety.

This web site is a little bit hidden from search engines which I regret. As resources become available to us, the one compensatory action we have is to link our web site with other more accessible and more easily searchable web sites.

We will continue our efforts to obtain technical support from the Department for modifications and improvements to our web site, and I would also document for the record that those efforts have begun some time ago.

I would finally--I see my deputy, who is actually the person who knows how to do this, wishes to speak, but I would also suggest to the committee that since its recommendations carry some weight, it might not be necessary for the committee to vote, but simply to express its interest. I can assure you that the staff will continue to respond as best we possibly can to your interests as well as your formal recommendations.

CAPT McMURTRY: Actually, the web site has been connected now to the DHHS home page. It used to not be accessible to the home page, but now if you will go to the HHS home page, click on Agencies, click on Office of the Secretary, click on Assistant Secretary down there, the fourth one down, it is more available than it used to be. It is not quite as hidden.

DR. NIGHTINGALE: We have yet to fully consult with our teenaged children, but we do have teenaged children available to assist us.

CAPT McMURTRY: If I could figure out a way to pay them.

DR. CAPLAN: What I want to make sure is that the Department puts the resources there to get this site up. I get a lot of questions wandering around from patients, people out in the community who cannot find the web site or do not find it quite user friendly yet.

So, as much as I am interested in an expression of interest, my view is it might be useful to have a vote and a directive to put the resources there to develop the web site.

DR. NIGHTINGALE: This is Steve Nightingale.

I would not propose that recommendation if it were made.

DR. PENNER: Why is it such a lengthy "www"? Why can't we condense that or consolidate it a little bit?

DR. NIGHTINGALE: The short answer is don't ask. The longer answer is a recommendation that might assist us to obtain additional resources to correct the problem that you raised.

DR. CAPLAN: So the motion is that we ask the Secretary to put the resources forward necessary to develop the web site, and that we have the web site pushed in the direction of more user friendly usage, which would include key recommendations and monitoring.

So I hear a second to that?

DR. PENNER: Second.

DR. CAPLAN: No more discussion.

All in favor?

[Show of hands.]

DR. CAPLAN: Opposed?

[No response.]

DR. CAPLAN: So resolved.

All right, a 10-minute break, and then we will come back to transfusion errors.

[Recess taken from 10:01 a.m. to 10:20 a.m.]

DR. CAPLAN: We have got Dr. GERald Sandler from Georgetown to talk about the use of barcode systems as a way to reduce the incidence of transfusion error.

I will turn the floor over to you, Dr. Sandler.

DR. SANDLER: Thank you, Mr. Chairman.

During the early part of yesterday afternoon, the committee heard a very thoughtful and informative presentation on the nature of human error, and toward the end of the afternoon, Dr. Jeanne Linden brought this committee a very focussed presentation on the very specific factors that lead to human error in a blood transfusion.

With Dr. Linden's permission, I am going to try and paraphrase what she told you, and that is based on 10 years of experience, she observed that in New York State, 70 percent of the cause of the wrong blood going to the wrong person occurred at the bedside, and 30 percent of the error occurred in the laboratory.

She showed you the picture of a nurse who was hanging a unit of blood and misidentified it. She told you that labels get mixed up, and she told you that components get misidentified.

She showed you in the laboratory that sometimes if the ink does not come out right, someone is going to read zero or "O" when it is a "B" or when it is--what was it?--a "B" or a "D" or something like that.

What I am going to show you now is a very specific solution to the problem that I think you have been hearing about. The device is called the I-TRAC. It is made and manufactured by Immucor and Partners. It is field-tested now at Georgetown University Medical Center.

In short, I can tell you, this is really terrific. It works very well. We have transfused more than 500 units using this. It will solve, in my opinion, about 90 percent of the identification issues. Nothing is going to solve all of them, but this one, I think, is going to solve most of them.

The concept of closing the loop is simply that over here we start to collect blood from the patient, and at that point is the first step where the error can occur.

We put a label on the tube. We send the tube to the laboratory with the label, and during the time in the laboratory, errors can occur reading it.

We identify a unit from inventory that is going to be cross-matched, and we send the cross-matched unit up to the floor. Again, we are back at the loop. Other opportunities occur where errors can be made in reading.

We are going to talk about a system where in my hospital there are no pencils, there are no pens, there are no erasers, and there is no paper that is involved in this.

I-TRAC Plus is a portable bedside barcode scanning system that provides electronic verification and tracking of the blood transfusion process, and the hardware is a Symbol SPT 1500 portable data terminal and a portable printer.

We are talking about something that is like a pocket notebook. It is like the palm-three that I have over here. I did not bring one in because they are actually using them at the moment over at the hospital, and the portable data printer is a battery-operated device which I am going to show you as I walk you through the system.

The features of the system are that it creates some prints, blood bank specimen tube labels at the bedside. It verifies identification of the transfusion recipient and the blood component at the time of blood administration. It documents electronically full transfusion data, including vital sign collections that the nurse takes, and I will show you how we put those into the chart on a sticky, all printed out.

In fact, I remember yesterday it was Dr. Ken Shine when he concluded. His last remark was, "You know, there is no reason why you can't use a palm-three to write orders and do other things," and that is exactly the kind of technology that we are talking about, and it generates transfusion reports.

Let me walk you through exactly what we are doing now in the infusion service at Georgetown University Hospital.

I do not have a focus, but if someone could keep me in focus, that might help.

The process starts when a physician places an order for a patient who is in the hospital, and we are going to add from the computer three bits of data. It is going to come out of this little printer that is on the side of the nursing unit computer.

Here is the risk band that we are generating and putting into barcode. So, from the mainframe data, we have taken the patient's first name, second name, and medical record number. We have transferred that electronically to a barcode printer at the nursing unit, and we are making a risk band in barcode, which looks like this. It says Dawn Rumsey over here, technologist's name actually in the blood bank. That is Dawn, that is Rumsey, and that is the medical record number in barcode identification. We are going to put that on the patient at the bedside.

What is happening here is the first step. This is the barcode reader. We are going to generate a label for a tube. Barcode label is over here. We are going to read that with the scanner. We are going to read the identification tag. I am wearing my identification tag. So we are going to take the scanner and we are going to read it, just like I am reading mine, and that is the electronic signature.

For this whole process, nobody signs anything. Everything is done. You have your own identification tag. We all have them to get in and get out of the hospital. You just read this, and it is an electronic signature. That is your signature, and that is how we work.

Those two readings, then, are transmitted by a laser beam. You could have a hard wire connecting them, but you just beam it. You just beam it and point it at the printer, and this is portable. It is battery-operated at the bedside. Out comes a label.

You stick the label on the tube. That tube comes down to the blood bank and it has got a barcode label. It will be registered in our mainframe, but most importantly, it is going to be read by the blood typing analyzer.

Let me just take a moment and go through the blood typing analyzer. You are looking at an instrument that is known as the ABS2000. It is FDA-cleared for work in a hospital transfusion service to do ABO and D typing of a patient sample. It performs an antibody screen, and it does cross-matches.

The key part of that in terms of this closing the loop is you drop the sample in, and it is all barcoded. It is all barcoded. So the information just gets transferred right through the system to the other end of it where we are going to take the unit that we have selected from general inventory, which already has a barcode on it, its own unit number. The unit of blood has its own unit number in barcode. We are going to barcode-read that. We are going to take the information that came out of the ABS2000, and we are going to generate over here a sticky label that is going to go on the back side of that unit. We are going to convert that unit from a general inventory.

This slide here shows you that we have the back side of a unit of blood, and we are sticking on the back side of that not to interfere with reading the color of the unit or anything. We are sticking on it a barcode that has been generated. It is called a compatibility barcode. It has got the same identification. It has got the first name, the second name, the unit number, and all the other information that we have generated.

There is an alternative. You do not have to own the fully automated walkaway ABS2000. You can do it in another way, and for about 5 percent of the cases that come into Georgetown University Hospital, we do not want to put it through the machine.

An absolute real state, for example, or some other things are not going to go through that way. So you can use the barcoded label through another system, and in Milan, Italy, where they have a similar operation to the one we are doing here--we are sort of partnered with them--they are doing this. First, they are doing it all in the Italian language, which is kind of interesting, through the electronics, and they are also doing it on a totally different instrument, one that happens not to be FDA-cleared for use in the United States.

We are back now with that unit that has been selected for the patient. We are back at the bedside. We are going to read the patient's label. We are going to read our own identification label. It is going to be a different person, and we are going to read the label on the unit. This is the compatibility label. We are going to read that label, and if all information does not match electronically, there will be an alarm sounded by the instrument. We will not be able to print the sticky label that is the key part.

There is the sticky label going into the patient's chart at the bedside, and essentially, what it says in very clear writing, much clearer than I can write, that Mary Jones, nurse, is transfusing blood to John Smith, such and such a number, 10:00 in the morning, and anything that she wants to add, those of you who know how to write in graffiti on the pound system, you could add whatever you would like to add onto that. Vital signs, whatever, would be useful, and you get a printed label, and most importantly, you have got the data electronically which you can download. You can carry 1,000 transfusion episode data in the instrument.

When you are through, you do the same thing. You take the unit down. You go through a similar procedure, and you would say when you finished. So there is a clear record in the chart, a clear electronic record in the instrument.

The I-TRAC Plus then provides positive identification of each transfusion recipient from the blood bank specimen collection through to the transfusion. It provides unique matching between the scanned barcode data at the time of the transfusion. It utilizes barcodes to ensure information integrity for the entire transfusion process.

The 15,000 single platform collects all the necessary transfusion process data and eliminates all bedside paperwork. As I say, nothing that you saw involved a pencil, an eraser, or paper. It establishes an audit trail, and it standardizes the operation procedure.

It improves productivity because one nurse can use this, and let me just take a moment and tell you that that was the key for establishing acceptance. In our hospital, and I hope in most of your hospitals, it takes two nurses to identify the unit before it is transfused, and typically, one nurse is busy and she is trying to take another one and they are going over this.

With the scanner, she gets the unit. She scans it. She gets the reading. She prints it out, and she really feels confident. She knows that this is better than pulling over someone else harried who is just going to do it quickly and just move on. They really like this.

All steps of the process are driven by screen prompts. So it is tightly standardized. I cannot read. So surely you cannot read it. It says that you can do this for any kind of a product. These are red cells. These are leukocyte-reduced red cells. I think these are platelets, plasma, and other things, and with a little bit of imagination, you can sort of run off over here and imagine that if you have got cyclophosphamide that you are going to give to someone, you could barcode cyclophosphamide and if you got IV potassium and if you have got insulin and so forth. So that, the cost of this as you think about implementing that can be expanded over perhaps a broader range than just blood transfusion.

This is just another benefit, and I think it can be focussed a tad, but what you are looking at here are the number of samples that came into the blood transfusion service at Georgetown during the time of the study.

This is the unit that we did for the pilot study, and we are still doing it. This is orthopedics, medicine, obstetrics, and gynecology. The little red things down over here show you that about 10 to 15 percent of all tubes that come into our blood bank drawn by interns, medical students, nurses, and house officers and so forth, they come in with the wrong signature or it says John Smith and the record is for Johnny F. Smith or something. Like we and everyone else in the industry, we bounce it back and we say everything must be perfect.

Here is the piece of paper, and, of course, there is all the hassle. About 10 percent of samples, including my own daughter's a few weeks ago, and I got a big hassle about that, are redrawn for blood transfusions. 0.00 are redrawn when you are using this system because it is all electronic and it all matches. So one of the side benefits, you eliminate all the hassle about the patient identification with the other issues that are involved.

Can I have the lights, please?

I am just going to close by giving you an anecdote of what happened to me last night. As I left here, I went back to Georgetown University Hospital where we were doing a 4-unit red cell exchange on a patient with sickle cell disease. I witnessed exactly what I knew I would be talking to you about today. One nurse has got the unit over here and she has got six pieces of paper over here, and she is getting this unit and she is getting that unit. She is trying to put it altogether and identify that, and I left while they were doing that because my wife had called and she wanted me to pick up some milk and some bagels for breakfast this morning.

I stopped off at the supermarket on the way back, and I got my milk for $1.59, swiped across the barcode. I got my bagels swiped across for $3 a bag. I took my visa card out, I put it in, and I said to myself, "The world is really topsy turvy." Life and death depend in hospitals in the United States on the nurses trying to figure this thing out, and they are probably still doing that, and for $1.59 a quart, I can get a barcoded milk bottle and I can get bagels in the United States. It is just upside-down in the way it is doing this.

I would like you to think about where we are heading with this. You did not create the problem here, but I think the solution is available to you, and I would like you to move on it.

Thank you.

DR. NIGHTINGALE: Steve Nightingale.

Gerry, I apologize for not reading the conflict-of-interest statement while you were in the room yesterday morning. I would ask you, could you acknowledge for the record if there are any financial obligations or arrangements that you have with any of the commercial firms that you discussed at the meeting, simply in the interest of fairness.

DR. SANDLER: I have no conflict of interest. I have previously received maybe one or two honoraria for making presentations from the company. I have no financial interest in the company and no conflict of interest.

DR. NIGHTINGALE: Thank you very much.

DR. CAPLAN: Jane?

DR. PILIAVIN: This is Jane Piliavin.

You brought this on yourself by using the grocery store analogy. There have been several exposés in newspapers regarding the inaccuracy of the barcoding of products in the grocery store, and I would like you to speak to the relevance of this for this product.

DR. SANDLER: The inaccuracies, Dr. Piliavin, if I understand that, are due to having the wrong barcode imprinted on the product. In other words, the Wheaties has got a Cheerios imprint on that.

We are generating the barcodes in this, obviously the reason one does a field trial. With regard to the specific patient transfusions, we have done about 500. We have done thousands of barcoded samples coming through the ABS2000. The ABS2000 at Georgetown--and we have two of them. You cannot get high-tech instrumentation and just have one instrument. So we have two, one here and one over there.

We run 95 percent of all blood samples in the transfusion service at Georgetown through the ABS2000. We are up to many thousands of samples. It goes to the number of about 15,000 which is our red cell transfusion per year because we have had it in for a year, without any barcode misidentification.

DR. PILIAVIN: Thank you.

MR. MacPHERSON: Gerry's presentation stimulated both a memory and also a suggestion.

Twenty-three years ago, there was a private-sector Government group called the Committee for Commonality and Blood Banking Automation that developed a specifications document that eventually became the labeling system that we currently use in blood banking today; that everything has to be barcoded.

A part of that specification is exactly what Gerry was talking about today in terms of barcoding for patient risk and identification systems. It got dropped off the specification and was not included in the final GMPs because the hospital said the technology would be too expensive at that time, and again, you are talking 23 years ago.

I am wondering if maybe it is time to resurrect the idea of including such a specification in the blood GMPs.

DR. PENNER: Response, Gerry?

DR. SANDLER: I cannot speak very specifically to cost, but I can make some general comments. I have asked the president who is in the audience what the cost of this would be for a hospital that transfuses 25,000 units, and he said it would be about $50,000 which is mostly hardware.

So, assuming that this thing is going to outdate in 2 years and then you are going to get version 2.0, then you divide 25,000 into 50,000 and including the hardware and everything, it is $2 a unit.

The six units of red cells that I got last night, I was thankful to get them in the current blood shortage, but they were surcharged to me, $40 for prestorage leukocyte reduction, a decision that I do not make. It is made by my community blood supplier. So I was charged $40 surcharge on each of these because someone thinks it is safer to do that at the present time.

I would rather have $2 worth of barcoding, and then I could pay for the whole thing, but decisions about that are not up to me.

DR. McCURDY: Gerry, I have got a question and perhaps a comment. The question is where can this system be overridden manually. Is there any place in this system that it can be overridden manually?

DR. SANDLER: Intentionally? Do you mean as an error, Dr. McCurdy, or do you mean someone could sabotage the system and cause an error?

DR. McCURDY: I am not thinking of sabotage. I am thinking of urgency, emergencies, things do not match, somebody says, "I know it is all right. We will just go ahead." I mean the sort of things that happen when you are harassed in either a blood bank or on the ward.

DR. SANDLER: First, for real emergencies, that is why I said I think this is going to work for 95 percent. For a real, real emergency, my version would be to take a Typonex type of sticky. The Typonex is a brand name for someone else's sticky system. We have got about 20 stickies, and you stick them on everything. You stick them on the patient. You stick them on the blood until you have names and other things. I would use a Typonex system that had a barcode, a unique barcode for each Typonex that was there.

So, in an emergency, I would take a little sticker that has got a barcode in it, and it might really be saying John Doe A. You stick the tubes that are being drawn, stick the patient, stick his thing, and go through the whole system. That is how I do a real, real emergency.

The question of how about overriding, I think the easiest way to override it is you are at the bedside. You read the tube here. You read your label here. You read the unit over here. You walk over here, and you give it to that person.

If you are going to have humans, humans can always find a way to screw up, and I think if you read everything off the wrist band and you are smart enough to know that this is the wrist band of this person, then you should give the blood to that person, but, yes, you could pick the unit up, answer the phone, and go to the left side of the room instead of the right. That can always happen.

DR. McCURDY: And will.

DR. SANDLER: Yes, yes.

DR. McCURDY: I mean, if it can, it will.

One more question before I make my comment. You mentioned that this eases staff load on the wards. Will that permit any reduction in staff? Because the only way you actually save money by reducing staff load is if it enables you to reduce staff so you have fewer people doing the same jobs.

DR. SANDLER: I would not say that from any of our experience we can reduce workload with the identification step. The identification step, we cannot reduce.

The ABS2000 in the blood bank did reduce one FTE out of 14 in the blood bank at Georgetown. I had a vacant position. I was to fill the position. I went to the administration and I said if you get us one of these automated machines, I will not ask to fill that position because we are going to batch test and it is a walkaway instrument. I put the batch stuff in, and it is going to come out the other end. So the person walks away while it is being done.

I do not have a specific financial personal interest in this, but my blood bank is obviously partnered with the company in the sense that they are during the pilot study providing us with instrumentation. You are not going to save money at the nursing level. You will at the tech level.

DR. McCURDY: The comment follows on a bit what Jim MacPherson said. Probably somewhere in the neighborhood of 5 to 7 or 8 years before his episode with the commonality, a pathologist at Georgetown University developed a system somewhat similar to this that was linked to the local blood center. This was done on a grant from NIH. I suspect a NHLBI or maybe before "Blood" was added.

It seemed to perform fairly well. It did not use the current technology, obviously. It was a but more cumbersome.

I know the blood center dropped the program because it was deemed too costly by the chapter manager. I do not know what the situation was at Georgetown, but I suspect it was the same reason that it was dropped when the grant expired. The more things changed, the more they become the same.

LT COL SARACENI: Dr. Sandler, you mentioned that this system is very economically for facilities that transfuse up to 25,000 units a year, but yesterday Dr. Linden presented data that showed that the most errors occurred in facilities that transfused less than 2,000 units a year. Would this type of automated system be cost effective for the smaller facilities, especially those that may not be able to afford the automated typing systems?

DR. SANDLER: I think the most precise answer I can give you is I cannot expertly address the economics of this, but your question was not that. Your question was cost effectiveness. We are dealing with infinitesimally small risk. I think we decided yesterday that there were something on the order of 10 to 12 fatalities that actually occur in the United States. So that little tiny hospital is going to have to try and figure something out in terms of cost effectiveness. The simple answer is you are just going to have to do it. It is a hell of a lot more cost effective than $40 surcharge on red cells for leukocyte reduction.

We are in a limited resource and we are spending the money, as far as I am concerned, in the wrong direction.

DR. McCURDY: Gerry, another thing occurred to me. I do not know if Hal Kaplan is in the audience. I believe that there is a lock-and-key system that was available at one time where you could lock up in the blood bank, and it could not be given until it was unlocked by something that was at the patient's bedside. Could those two systems be combined? Is it reasonable? Maybe Hal would like to comment.

DR. SANDLER: I think someone on your committee plans to do a show and tell on blood lock, and I do not see the need to add another device to this system. I think this system covers all of the issues regarding blood lock. Plus, it provides electronic record-keeping. So you have records of absolutely everything that went on the floor.

We are talking about cost effectiveness. My son is a medical resident, and he tells me that absolutely every one of the residents are moving from palm threes to palm fives now because they have got the program that requires 8 megabytes of information on drug data. So every drug is going to be on this. You can scan and you can read this.

I am with Ken Shine. I think this is the way of the future, and I think that if my hospital partnered with the residents and said, "We are going to buy you one of these things here and you just pay us $100, but it has got on it the software program for the I-TRAC. Everything you do is going to have an electronic signature to it, and when you leave this program, you can keep this thing," I think there are ways if we just went in and said, "Okay, we are at Version 1.0, but let's get going with this kind of thing," rather than staying where we are.

DR. CAPLAN: That actually leads me to my question. One group that is out on the frontier of barcoding in addition to groceries is the rental car business which will not let you out until you swipe. So they lock up automatically. Yet, at the same time, they are moving to chip technology. They do not want to deal with any paper anywhere. They are going to put chips into every one of their cars. No one does anything. The car will not leave until it is sort of rented out.

One of the things that people want to know sometimes is this--while we ought to get going at some time, is this the technology to go with or should we sort of microchip ourselves and then just scan ourselves with the information on the blood banks.

Some Wired magazine devotee would be in here saying, "This technology looks old to me."

DR. SANDLER: Yes, yes. You are entirely right. I asked my teenager should my wife get a new computer. He says, "No. Wait until 2 more years. You will not even recognize it."

I think you really have to jump in. I think that we really have to jump in and take the technology that is there. We have had four iterations of this.

We started out with something just like the Avis system. It looked like a handheld telephone, and we brought it up to the nurses and they said all right and it was just too awkward.

I went to the company and I said to them, "Hey, why don't you approach these people and ask them if they can put that on this?," and we ended up with that version. Things do not happen if you do not get in.

We can stand aside in blood banking and watch the airplanes do their thing and watch everybody else, or we can move forward for safety and make some good choices. I would like to see us start that.

DR. CAPLAN: Dr. Kaplan?

DR. KAPLAN: I just wanted to comment. We have one of the world's experts. One of the differences between blood lock and this elegant system is blood lock is a forcing function.

When you are in a building and you go down the stairs and you get to the ground level, you do not ordinarily get into the basement without having to go through some barrier, either another entrance or through a gate. That is to stop people when they are in a fire from running into the basement. It is a forcing function. By having a mechanical lock, it forces you to stop and do something the right way. Jim has got the world's experience.

DR. AuBUCHON: Well, unfortunately, this committee has had to listen to my harangues in the paste about the importance of mistransfusion, but I wanted to demonstrate to you that this is something that we actually have paid attention to at Dartmouth Hitchcock Medical Center.

We have been using the blood lock system, a mechanical barrier system, to prevent mistransfusion for over 8 years, for over 80,000 red cell transfusions. It is a very simple system that I would be happy to demonstrate for you here.

It begins when a patient is admitted and receives a wrist band. This wrist band is not barcoded. It is a standard readable wrist band, but at the point where the patient is wrist-banded, the admitting officer will peel off a randomly selected, randomly encoded 3-letter code which is merely stuck on the patient's wrist band. The patient gets that regardless of whether or not they may ever receive a transfusion.

When the pretransfusion specimen is drawn, this 3-letter code, as well as all the other information that we require in the blood bank, is transferred to the label of the two. Ultimately, that information is used to set one of these plastic locks before the red cell unit is released for transfusion. The locks are generic. They do not come preset from the manufacturer. You simply dial in the code that you have received on the pretransfusion testing, press it down. The little ring pops off the back, and now this lock will only open to--I have set it for ABC.

The lock can then be used to prevent access to the unit at an inappropriate patient's bedside. There are a couple of ways that this can be done. If multiple units are going to be sent, for example, to the operating room or any other situation, units can be put in a bag and the bag can be closed with this lock.

As you see, it takes a moment, but it can be done, if you want to play with that, send it around, show and tell, as was said.

Also, it is interesting hat it has been able to be engineered that on the blood bags of one blood bag manufacturer, the one that has the majority of market share in this country, there are two little holes at the top.

I am not very facile with this. My technologists do this. I do not, but the two holes can be lined up with pegs on the back of the lock, and then the lock can be closed over such like that.

When the tranfusionist goes to give the transfusion, he or she must, of course, check all of the printed information on the label as to the identity of the intended recipient and check that with the wrist band of the patient, but then they actually have to deal with this lock. They have to get it off, and the only place that they have the code written to open this lock is the wrist band of the patient, importantly the wrist band of the patient who gave the pretransfusion specimen. So, even if all of the other information is incorrect, they cannot get access to the lock without the blood lock opening up.

Admittedly, it is possible to carefully cut this off, and these are not brass padlocks. You can pick them if you try hard enough, but what we advise our staff is that if this lock will not open, there is a reason for it. Call us. We need to find out what the story is.

We have, as I said, been using this lock for about 80,000 red cell transfusions. The problems in terms of the lock not opening when it should happened very infrequently. We have systems in place to deal with emergency transfusions, should they be necessary, where the patient has not yet had a sample collected with this code, but importantly, it has prevented three mistransfusions in our hospital where units would have gone to the wrong patient if this system had not been used.

I certainly do not hold up our institution as a perfect one, but I am not aware that we had any great labeling or identification problem with our patients. I think we actually have quite a good system for that, but one of these cases is another case where you can understand from the studies that Dr. Linden showed yesterday just exactly how these things can happen.

One day in the ICU, it was noontime, and what happens is that half of the nurses go to lunch and the other half take care of two patients at a time. One nurse was left with two patients, both of whom needed transfusion, and a unit of blood arrived via the pneumatic tube system.

Delivery by pneumatic tube system is one of the things that Dr. Linden has noted as possibly increased the risk of mistransfusion, but that is how we have to do it at our institution.

She took the unit of blood and said, "Oh, this is for Patient A," and walked to the bedside of Patient A. She and another nurse both checked the written information on the back of that unit and verified that it was for Patient A. It was not for Patient A. It was for Patient B. They missed it. They were expecting to see Patient A's name, and that is what they saw, but that is not what was printed.

They could not open the blood lock because they did not have the right code from Patient A. It was Patient B's code that the lock was encoded with, and we got kind of a snitty call from this nurse telling us that our blood lock would not open. We asked what patient they were trying to transfuse, and when they told us, we told them, "Well, we have not sent any blood up on that patient." Silence from the other end of the phone, and a much more congenial atmosphere then ensued. The right patient ultimately got transfused. It is just one example of how this kind of barrier system might work.

We have had the opportunity to trial the I-TRAC and are very impressed with its capabilities. We particularly like the idea that it can produce a written record that can go in the patient's chart that all of the checks were done appropriately, and you have all of the transfusion-related information right there.

One thing that has prevented us from adopting it and going away from the mechanical barrier system, and it is something that Dr. McCurdy noted, there is not an absolute requirement that it be used. It can be bypassed. You have a unit of blood. There is nothing to prevent someone from looking at the I-readable labels and say, "Yep, that is the right unit for the right patient," and going ahead and transfusing it.

We are particularly concerned in the operating room where that may happen, where things can happen quite quickly. There is a perceived immediate need for blood, and everyone in the room just assumes that, yes, that is indeed the right unit for the right patient.

With a blood lock, they have to deal with it. They have to get it off the unit somehow before they can get to the blood, and that, we feel, is an important safety measure.

So, actually, our anesthesiologists who admittedly are not the world's greatest proponents of this mechanical barrier system are the ones who said, "No, we don't want to leave the mechanical barrier system to go to the electronic system because we could bypass it, and we know we could and we know we would occasionally."

So there are multiple ways to skin a cat. I agree with Dr. Sandler that we as blood bankers need to do something and need to do something now. We needed to do something long before now, but certainly now we need to do something. There are some simple ways and some more complicated ways of doing it.

Unfortunately, there are only 25 hospitals out of almost 6,000 in the country that use this mechanical barrier system--25, and that is not a growing number either, I don't think, or not by leaps and bounds. It surprises me.

Yes, it costs money. These locks cost about $3 each, and although they are technically reusable, frankly it is too much trouble to try to reset them. So no one reuses them.

We have, of course, coming from the land of decision analysis in Dartmouth, performed a cost-effectiveness analysis on using a mechanical barrier system, and it does cost society some money for us to use this.

On the other hand, if you put the hospital's perspective into that analysis, it is cheaper to buy a $3 lock and to use it than it is to pay for the care of a patient who receives the wrong unit of blood, albeit it extremely rarely, but to pay for the care of that patient and to, of course, pay for the consequent legal bills and liability judgment which will come from having transfused the wrong unit to the patient.

Therefore, we think this make sense not only from an economic perspective, but does make sense by making transfusion safer.

DR. CAPLAN: I am going to take a couple more comments here.

Fernando?

DR. GUERRA: Dr. Sandler, do you know if the technology is far enough along that is used by the criminal justice system, by INS and by DOD to use fingerprints? In scanning that, just to build in that additional level of reassurance, if one could do that, I think that one could certainly match a fingerprint from an individual that has provided the sample and then matching it with the unit that is going to that individual. Could that be built in as part of the scanning?

DR. SANDLER: The answer is, of course, I do not know.

I have talked to the technical people who are involved in developing this about retinal scanning. There is a technology of identification that banks are looking at where they read the retina, and that is a unique print.

My guess would be that in the medical situation, there will be enough material that is going to get on the key fingerprint, whether it is blood or other materials, that it is probably not going to be a desirable and long-term system. Plus, of course, to get a fingerprint, you have got to have a pretty controlled situation. People are sick, and it just may not be the technology. Bottom line, I don't know.

DR. DAVEY: Just on the front end of the process on the donor identification side which is a little different from what Gerry and Jim have been addressing, the fingerprint technology and iris scanning--I believe it is iris scanning--technology are now being evaluated to make sure the right donor is indeed showing up and identifying themself properly.

So the technology exists. I think it is easier to implement it at a blood center than in a hospital, but it is coming along.

DR. NIGHTINGALE: This is Steve Nightingale.

It is in the interest of the committee that all commercial interests who would wish to be represented in a discussion of this sort would have access to our microphone.

I have one question. Is there anyone in the audience who either represents or has an interest in a commercially marketed, within the United States, system that has not been addressed here?

I see none, but I would like to state for the record if there is such an individual or entity, if that individual or entity would provide the committee, myself, with any material that it wishes to be distributed to the membership of the committee between now and April 15th, 2000, please provide 30 copies or 30 samples and I will see that it is distributed to all the membership.

DR. CAPLAN: Why don't we do Keith, and then I think we are going to move on to the public comment.

DR. HOOTS: I think Dr. Kaplan yesterday was talking about patient-related factors as one of the contributors to error, and actually, as you talk about events in the technology, the one advance of either having iris or retinal scanning would be that presumably you could buy at least--I don't know if you could, but if you knew that there was a master to which to compare, you could at least eliminate that source of people using or borrowing cards coming into the institution and getting the wrong blood. Again, you would have to have some sort of standard against which to measure it, and I do not know how the banks or the ATMs are planning to exactly deal with that, but I am sure they have a strategy. So, presumably, whatever strategy they implement for that should work similarly for either donors or for recipients, and that would at least curtail that particular facet.

DR. SANDLER: Let me just respond by stating that the goal of this as we use it at Georgetown is to replace the second person. That is to say, as we go through and as we have it fully implemented in the oncology infusion service, the nurse still looks at the patient, looks at the bag, looks at the tube, and the tech does the same thing.

The second person, however, is the electronic identification which leads to the recording of all of the data as well.

So we are not at the point where we would propose that this is so fail-safe that you just go and barcode everything and just move it right along. We do the visual reading as usual, but the double check is done this way, and that is how we accumulate the data as well.

DR. CAPLAN: Thank you.

Steve, what do you have for public comment? Do you have any list developed?

DR. NIGHTINGALE: I do not have a list developed. I know that blood centers, American Association of Blood Banks, there are a number of individuals. Ms. Bogner, whose book you have all seen, I believe wishes to make a comment.

Jan, I have yours as well.

I think that what I would like to do is start out with our previous precedent of alphabetical order and have those who wish to comment roughly arrange themselves in alphabetical order.

In the Federal Register, there is a 3-minute limitation on public comment. I think that we can be somewhat flexible with that, but I would most emphatically encourage all of the public commenters to stick as close to the point as they possibly could, being as how this has been a physically trying as well as temporally long meeting.

The American Association of Blood Banks, America's Blood Centers--American Red Cross does not wish to comment. Then I think after that, we go to "B" for Bogner. Then we would go to "C" for Cott and move on from there. If that is acceptable, we will start that way.

MS. GREGORY: Thank you.

I have provided you with a copy of our complete statement. So what I will try to do is summarize and keep my comments as short as possible because I know I cannot fit them all into 3 minutes.

First of all, you heard yesterday about the AABB commitment to quality. You heard other people talk about that. We are a standard-setting organization.

Can I have the next overhead, please?

We have been setting standards since the 1950's. So we have been in this for a while. Since 1991, we have also required every facility to develop and implement a program of quality assurance or a quality program, and since 1998, we have had all institutional members as a requirement for their accreditation to have a quality program in place. Error detection and monitoring is a part of that particular quality program.

Mike, skip the second slide and go to the third one.

I want to talk for a minute about elements of error reporting. First of all, it is important that we have a common terminology, and I think this is something we really need to work on because the definitions in the IOM reports for mandatory and voluntary are very different, I believe, from the way we in the blood bank industry have been using voluntary and mandatory. So whatever we want to work on, we need to make sure that we are using the same definitions and talking about exactly the same things.

We are used to using "mandatory" to mean somebody requires you, and there may be a penalty attached, but we do not attach to that what kind of information necessarily would be reported.

"Voluntary," we define as being the ability where we would just act on our own initiative.

Next slide, Mike.

I want to talk for just a minute about a voluntary reporting system that you may not have been aware of, and this is the BaCon study or the bacterial contamination study.

This really was intended to be a research project rather than a reporting mechanism, but I think it fits nicely into the idea of voluntarily reporting things.

What this study was, it is a cooperative effort between the CDC, the AABB, the American Red Cross, and the Department of Defense in which we ask people to voluntarily report to us adverse reactions that patients have that are due to bacterial contamination products. Our experience with the study illustrates the problem with voluntary reporting.

Go to the next slide, Mike.

Out of 970 AABB facilities that we contacted and asked to participate in the voluntary study, only 128 agreed to do so. Thirty-five of them were blood centers. Ninety-three were transfusion services.

I think the disparity also shows up if you look at the kinds of case reports that we have actually received over about an 18-month period, and that is that we have 11 reports that came in through the Red Cross system and only 6 that came in through the AABB system. I think the difference is that the Red Cross has a more structured system in which they already require their transfusion services to report any product defects to them.

All of the product defects that are reported to their national headquarters--and they, of course, can see that it gets reported, then, to the BaCon study.

On the other hand, the AABB has to rely strictly on voluntary reporting, and we have had fewer cases. As a matter of fact, some of the cases that did come through the AABB system actually probably were not voluntary reporting so much as they were the FDA and cooperating with the CDC, notified the CDC about a potential fatality and asked for some further investigation. We then got in touch with them and made sure that they did do the reporting through the AABB system.

So a voluntary system, while nice, may not work unless there is some sort of incentive, and as a matter of fact, the BaConÊstudy has now gone so far as to establish an incentive, not an incentive per se, but remuneration to help the transfusion services recoup the cost of what they need to do to do the investigation of these potential bacterial cases.

I cannot tell you if that really makes the difference or not, but that is certainly something that we are going to monitor.

Next slide.

I mentioned funding. We also think that the data collection, the analysis, and the use of the reported event, what it is you are going to do with it, are all very important issues.

We agree that the reporting of near-misses is desirable, but it will not accomplish a useful purpose if the system is overwhelmed with data and the data are not analyzed appropriately.

So, in order to build support for a system, it may be necessary to start with more limited event reporting, establish that, and then move on to making the system a little larger and doing more information.

The reporting system to be successful has to be streamlined and easy to accomplish and provide meaningful data.

You heard yesterday that since 1991, the FDA had asked for voluntary reporting for unlicensed registered blood banks and transfusion services, and that has not really been very successful, as even they admit.

We believe that it is partly because it is difficult to figure out exactly what you are supposed to report, although they have improved that, but finally they don't analyze and turn the data in a format that is particularly useful, especially to hospital transfusion services. It is somewhat more useful to blood collection agencies, but the hospital transfusion services really cannot make very good use of this data. So we think that is one of the reasons why the voluntary reporting may not have been successful.

You also heard yesterday that in 1977, they proposed a rule to make error reporting mandatory for everyone, and I should tell you the AABB did oppose that rule as it was proposed. However, there are ways to address our concerns, and we do not oppose mandatory or required reporting if it will ultimately assist blood centers and hospitals in improving transfusion safety.

Finally, one thing I left off my overhead here is punitive action, and that is any reporting system. Blood facilities need to feel free to report without the threat of regulatory action, et cetera.

Next slide, Mike.

In terms of how to integrate new and existing initiatives, we do have some ideas on this. One is we believe that we should support existing systems.

The BaCon system now is pretty well established for reporting bacterial contamination problems, and we certainly would like to see that continue, not necessarily as a research project, but perhaps as a surveillance system.

While we have concerns about the FDA reporting system and we do think it can be improved--and we heard yesterday from Ms. O'Callaghan some of the ideas that they are thinking about--we do believe that this system should be continued and should be applied to licensed and registered collection facilities.

On the other hand, however, for transfusion services in particular, we would recommend establishing a new system for error tracking.

The FDA does not have the same expertise in transfusion service activities as they have in product manufacturer, but we would rather see them spend their time and energies upgrading their system and allow the private sector or someone else to work on transfusion service error reporting.

We also support funding for the National Blood Data Resource Center as the mechanism for this new system, and we are very interested in utilizing something like the MERS-TM system that you heard about yesterday. Remember, they talked about the possibility of having central reporting, and we think that NBDRC would be a good place for this central reporting.

One thing also is that we understand that we will need to continue fatality reporting to the FDA because that already is a regulation. So we certainly agree with that approach as well, although it may be that there may be a different way of doing it than what we do now, but the fatalities that are reported are very few in any one year. Consequently, they can get somewhat immediate attention at the FDA.

Next slide.

Finally, one of the questions was about other actions to improve safety, and we think that probably as important as the reporting of adverse events and near-misses is a requirement that the facilities have in place, an effective and appropriately implemented quality system. Good quality systems all have comparable elements in common, including the internal capture analysis and correction of events that deviate from regulatory and voluntary standard requirements and the conduct of internal audits of all activities. These tools more than reporting requirements probably have the power to solve or improve transfusion safety.

In summary, the AABB supports reporting of errors when such a system contributes to improving patient safety and stands ready to provide its member expertise and experience in designing and implementing such a system.

Thank you.

DR. NIGHTINGALE: Thank you.

America's Blood Centers, I believe, wishes to speak.

MR. MacPHERSON: Our excellent and crisp statement is being passed out. I will spare you reading the statement and go to some of the main points of the statement.

First off, the bottom line here is that slide. This is the first conference that I am aware of in which we have had some serious discussions about the major remaining cause of death related to transfusions. We have had probably a half-a-dozen on bacterial contamination with no resolution, and I think that it is due time that we focussed on the real problem today.

We, the independent community of blood centers that represent about half the blood supply, have been under a mandatory system since time in memorial, I think since the TMPs were first promulgated in the 1970's, and we think it should be extended to all blood facilities, including transfusion services, no doubt, no question at all. It works.

The threat of FDA intervention has enormous impetus on improving quality within a blood center, and will within a transfusion service as well.

The mechanisms for doing it are kind of complicated. We have outlined them in our statement having to do with HCFA and some dance that will need to be done between FDA and HCFA and updating perhaps their memorandum of understanding as to how FDA rules will apply to in essence unrelated facilities, but facilities nonetheless that receive funding from HCFA.

We will also believe that there is an excellent model for a voluntary system and a non-punitive system, and that is called CITINGS. I do not know how many of you are aware of CITINGS, but about 10 years ago, ABC founded CITINGS. We then took CITINGS and assigned the rights to a private sector organization, a not-for-profit private sector organization, that runs it on a prescription service and has, I would say, probably 95 percent of the blood collectors and all the plasma collectors subscribed to it and are part of it.

What it does is that the individual organizations report anonymously. They report their FDA citations and the corrective action that they have put into place, and experts in blood banking pore over that material and then publish any new findings and any interesting and novel corrective action to the entire community on a monthly basis.

They also report on a quarterly basis, trends and statistical analyses. So I would support what Jeanne Linden said yesterday, and that is in any reporting system, what you need is both statistics to show trends and to show where you can bench-mark yourself within those trends, but also the narratives are what really provides the most important information because that is where the corrective action is and that is what all the quality assurance people look for when they go through CITINGS.

So we would say there is a system out there. It already works and could be easily adapted as well to error reporting, and would encourage that that be looked into. In fact, we will encourage the CITINGS people to look into that as well.

I think that the most important message that we can give today is keep it simple and do it now.

Thanks.

DR. NIGHTINGALE: Is there anyone who wishes to speak whose name begins with any letters before B-o, before Ms. Bogner? If not, I think Ms. Bogner would be our next speaker.

MS. BOGNER: Thank you. I had almost decided not to speak, but in hearing what you are talking about, reporting error--and my area of expertise and you have seen my book--I have been involved in error in medicine since the lonely boys in the wilderness, in the early '90s. I would encourage everyone not to stop at an organization level or look down within an organization to see what the contributing factors are to any error, but to look up also to see what may be going on in society, if you will, and policy and legislation, in reimbursement policies. All of these factors come down through the various systems and affect what you are doing in providing care.

In my book, if you have a copy, you can look at Neva Moray's chapter. He has what he calls an onion model, which is square, but it shows the various levels of systems that do impact on the care provider and how they do affect the care provider. So, again, I encourage you looking up as well as down.

Thank you.

DR. NIGHTINGALE: Thank you.

I believe that the next speaker that I am aware of begins with C-o for "Committee." Is there anyone before "Committee" who wishes to speak?

If not, does the representative of the Committee of Ten Thousand wish to speak?

MR. DUBIN: I am Corey Dubin. I am with the Committee of Ten Thousand.

You mean you guys are not going to make any comments? You are going to let me get away with it? Not bad.

Let me say a couple of things.

DR. CAPLAN: I am still smarting over the Ph.D. cracks from yesterday.

[Laughter.]

MR. DUBIN: Let me start by saying two things, and I am going to steal somebody else's quote, but I think it is good. Any mandatory system is at its heart voluntary, and I think that is important to remember.

The second thing I think that is important to remember for all of us in this room who have a stake in this is errors are hot on the Hill and they are going to do something.

When Arlen Specter and Senator Jeffords hold hearings within 2 days on this issue and Bliley is knocking around to do the same, they are going to do something. As we all know, there are very few Members of Congress who understand this issue at any real depth, and if we allow them to take the ball and run, on all sides of this, we may well regret the result.

Another quote I heard this morning was Congress is not a scalpel. They are more like a hammer. This issue may take a scalpel. That said, I think we have got to think out of the box. We keep talking about new paradigm, but I am going to change that a little so maybe I can be clearer and talk about out of the box.

I was a little surprised at the IOM report because the IOM did such a superb job on HIV and the blood supply that I think we got spoiled.

The concept that consumers are not much more than potential litigants is a little distressing to us. Obviously, our organization has been in the thick of the Blood Products Advisory Committee and this committee for a good part of the '90s and not been totally wrapped up in litigation. Had our way happened, the original class action filed on blood products would have been used as a negotiation vehicle and we would have been done a long time ago.

That said, there is a direct--not quite an oxymoron, but a contradiction in the IOM report. I think, again, we are talking about liability, but we are just not really using the words directly.

If we really want to create a culture of safety, we have to create a culture of trust. If we are going to continue to talk about liability questions and liability fears, but kind of couch them in other terms, then I do not think we are working towards building a culture of trust.

I think what the blood banks are concerned about is liability on some level, and I think we understand that. If it is liability protection that in part is sought, understand we are not necessarily opposed to that at its front end. What we want to do is seek a landscape solution that includes, for instance, no-fault compensation structure. At the same time, we do not want to create a new national blood shield law. So we would like to put that no-fault compensation as part of a package that is a blood policy that serves all of our needs.

Let me say this. We had to go a long way towards getting over how pissed off we were to get to the table a long time ago. We feel that some elements in this process are still looking over at our shoulder at us like we are chasing you. Let's be clear that is not the goal.

The goal is to put together some intelligent prospective solutions to what our problems that we all have to wrestle with, be they donors, be they liability questions, and no one would argue this is a litigious society, but we can get around this. We continue to be a little amazed that we are not farther along in this process. I think we are clear about what people in blood banks and in the industry are after in terms of some protection. I think it is time you all be clear about what we are after and be clear about what our goals are. I think we are almost continuing to be in the Dark Ages around some of the questions.

I know I am not right on the question, Steve, but I am close because this really speaks to it.

We ought to put this away. There are solutions to these problems that can be had, and if we leave it to Congress, we are all going to regret it, but as you and I have talked about, Rick, if we went up on the Hill together with a plan, we could sell it to Bliley, as Dana and I hae talked about, we could sell it to Waxman. I think they would be surprised to see us up there together, and I think we could do this.

We were really a little upset at the IOM reports. All we got out of it is you guys are potential litigants. Well, we are a lot more than that, and you are a lot more than any kind of narrow construction that may occur.

I think the Canadian success that we have all seen and heard about has much to do with trust. We got to get to a position of trust, and when consumers or public interest groups see a report where inherent in the slides are we are only going to give the public some information, the public asks what the heck are you hiding.

I do not think you have got a whole lot to hide. I think the real concern is if error and accidents get on the table too much, they are going to contribute when somebody really gets hurt to their lawyers being able to show a pattern. Let's cut to the chase.

So how do we consider that in the context of building in some protections that reduces that concern on the blood banking side and the industry side, at the same time addressing our concerns which are we do not want to go back to the old blood shield law kind of structure, but we do understand the need for protection. So our approach is let's talk about a larger policy that includes no-fault compensation or some form. I do not even want to put a word to it.

I think we are definitely not looking for a reporting system that is punitive to people working in the blood bank. That is the last thing we are after.

A culture of safety is going to need people getting excited, working on a team, and not feeling like they are going to get heavily punitively attacked if they make a mistake. People make mistakes.

I think the only place you have got to take it out of that context is when there is really gross negligence, but the norm is not gross negligence. The norm is humans make mistakes.

So how do we create a system where we know the harmful errors are going to be reported, but we also know that we are going to get enough data kicked up the system to see trends in near-misses that might tell us if maybe three or four institutions are using the same software and the same near-miss keeps popping up. FDA might be able to look at that and say we have a software problem or we need to do this kind of in-service. I think we agree with a lot of what was said by Dr. Linden about New York. So I do not need to revisit it, but I think it is important.

Something you said to me, Jay, was important. Resources, where do you draw the line? You cannot have giant amounts of data flowing in and no one to go through it. So maybe a sampling, shorter term, like AABB was talking about would be a good idea.

I think we have got to talk about resources. The IOM talks about the agency, the FDA, doing post-market surveillance. When Dana and I met with Commissioner Henney in the spring, she said, "Post-market surveillance. I have got to have a lot more resources to do that, gentlemen." Congress has got to understand that it takes bodies and time to do post-market surveillance.

So how do we take it to the next step and get out of this box we are in? We are in this box. I think you all sometimes are looking over your shoulders wondering who we want to hammer next, and we are looking at you all wondering when you are going to hand us something that we think is trust-building. We have been going around like this for a lot of years, and it seems to me in this room, we have some of the brightest and most well-thought-out people on this issue in this country and in the world, and it would be very nice to go to the next step and put the stakeholders together in a way that says let's get to work and let's develop a comprehensive plan that meets all of these issues, meets the liability questions, because we keep talking about liability in couched terms. Let's cut that out. Let's talk about what that really us.

For us, the trust issue, which I think can be met and in some ways has begun to be met in this committee and elsewhere--because I keep going back. Congress is going to do something about this error thing, and what they may do may be ugly for a lot of the perspectives in this room because the education and the subtlety needed to solve this problem is not there.

I think one of the models for us--and I had told Dr. Gomperts, I was going to mention this--the Committee of Ten Thousand in the middle of the worst part of the fight made a reach out to Baxter, and there were enough enlightened people in the leadership of that company at that moment to respond. Very good things have happened to the degree where Terry Rice and I toured their new recombinant factory, something that could not happen 5 years ago because of the outrage that the community would have expressed.

So I think there really is a way to do this, but I think we keep getting caught. I think the IOM report surprised us in reading it. We certainly do not think they attained the level they attained in HIV in the blood supply. However, I will say they did structure the argument generally well and raised the issues well.

I think the challenge to us now is how to get together and answer these questions that all relate to each other because I think creating a culture of safety is what we all want, and beating people over the head is not going to get you a culture of safety because, again, even a mandatory system that it is voluntary.

I think we learned that as well as anyone, and I think we have to move in that direction. There just has to be a decision that there is going to be more trust than there is and a realization that somehow we are not just sitting in the corner with a phone waiting to call the next lawyer to find out who is ready to sue some of you guys. Let's be really candid. Our experience in the courts has not been too good, if you really look at it. Our experience here has been better. Our experience at the BPAC has been better. These are the environments where we are consumers made real gains and want to continue to do that, but I think we keep bouncing off this same wall.

This morning, when we were all thinking about it, the wall has something to do with liability and it has something to do with trust. So I think that is where we need to break through.

To get more specific in closing and just to circle back and restate that part, somewhere there needs to be a balance between voluntary and mandatory. We think if all near-misses are simply voluntary, then how are we going to collect trend data?

We also agree that you want processes going on inside individual blood banks that move towards this team approach where people get with the data and say what have we got to do, but we also think we have seen enough of regional differences from, say, Buffalo to Portland or Miami to L.A., that there is a need for data on near-misses to come in that gives you a trend picture. Maybe it is a sampling of data. I am not quite sure how we do this. Dr. Epstein raised a point with me, "What are you going to do with all this data flowing into the agency all at once?," and I think that is a valid point that we went away and started thinking about, but we do think if it becomes completely mandatory, you lose some of that data that gives you the opportunity to say we need to do this in-service on this issue or change this software.

So I think this is an important issue, and I am going to circle back and say something for the third time on my way out. I think that we need to fill the vacuum that Congress is about to fill because, again, the people in this room understands what needs to happen in a very good way and are in the trenches, so to speak, doing the work.

I can only think of one or two aides that Dana and I have ever met in 6 years on the Hill that really understand this issue well enough to craft legislation. It is a little scary, I think all of us would agree, if they start pumping out legislation on error and accident reporting.

Lastly, again, I will leave everyone with a challenge. Let's go to the next phase. Let's hear what the Canadians have done and see some of that and understand that it is high time that we get to that level so we can iron these problems out that get in our way to the point where there is a degree of trust which will absolutely build a culture of safety.

Thank you.

DR. NIGHTINGALE: Thank you.

I am aware that the Hemophilia Federation of America and the National Blood Data Resource Center wish to make a public comment.

I have received a public statement by the Medical Device Manufacturers Association, if there is a representative in the room.

Is there anyone else who wishes to make a public comment? Could you raise your hand if you do? There most certainly is.

DR. CAPLAN: If people do, the Chair would ask that you not read your statements into the record. We have got them. We will read them. So, if people are coming up for comment, just in the interest of time at this point--I want to watch that 3-to-5-minute window, but if you have a statement, you do not have to read it to us.

DR. NIGHTINGALE: We have Hemophilia Federation of America. Then I think the Joint Commission will be afterwards.

MS. HAMILTON: Hi. I am Jan Hamilton, Hemophilia Federation of America.

I just wanted to have a little preface. You have my statement. It is short. I just wanted to say that over the last couple of years, at least three members of my family and two very close friends have been in a hospital in a situation in which they received blood and blood products, and while Dr. AuBuchon was speaking a while ago, I really got chills down my spine because I revisited several of those incidents.

I feel like I am very much aware of what is going on, and when I got scared of looking at what was happening, it really kind of shook me and made me think what about those people who are not as aware as we are in this room of what is happening to them when a loved one goes to receive as blood transfusion.

The comment from one of the physicians to me, when my father had to receive two units of red blood cells because of an extreme anemic situation that just popped up, it was we don't have to worry, the blood supply is very, very clean today. I said, "Yes, it is cleaner than it ever has been, but we still have to worry about human error."

So I am very much aware of what is happening here, and I would say to those of us who have braved the elements and come out that we have been able to listen to some very good things over this weekend and we hope that some of them will actually come to pass.

The biggest point that I wanted to make really in my statement is I have had a bone for the last several years that I wanted to hit on, and that was I do not really understand why there is such a thing as an unlicensed facility that deals with blood and blood products. Somebody can die from that blood product issued in the wrong manner, just like they can from one that is licensed, and if we have to change the wording and change the channeling, let's do it. Let's protect these people and save lives.

Thank you.

DR. NIGHTINGALE: The Joint Commission on Accreditation of Health Care Organizations wishes to speak, and after that, I think we have the National Blood Data Resource Center.

MR. CROATO: Thank you.

My name is Rick Croato. I am with Joint Commission on Accreditation of Health Care Organizations. I appreciate the opportunity to talk with the committee.

I have been very pleased in listening to your discussions and the presentations that you have received. It is certainly consistent and very supportive of the objectives of the Joint Commission in this area. The improvement of safety in health care has been a focus of the Joint Commission since its inception, and it has been formalized, as you have heard, over the last 4 years, through the implementation of our sentinel event policy.

We believe that there is currently no more important issue facing health care today than medical errors, and we do endorse clearly the concept that safety must be systematically designed into health care.

The sentinel event policy and our accreditation standards require each of the 20,000 or so organizations that we accredit to have procedures in place to identify, to report, and to manage unanticipated serious outcomes, what we call sentinel events.

This policy requires accredited organizations to determine the root causes and to implement improvements to reduce the likelihood of similar events and monitor the effectiveness of these improvements.

By working with accredited organizations to ensure that thorough and credible root-cause analyses are conducted whenever sentinel events occur and by collecting and aggregating information derived from those analyses, the Joint Commission has been able to alert health care organizations to potentially deadly errors, to their underlying causes, and potential risk reduction strategies through a national bulletin that we publish periodically called Sentinel Event Alert.

Over the past 2 years, we have issued Sentinel Event Alerts addressing transfusion errors, medication errors, wrong-site surgery, inpatient suicides, infant abductions, and restraint-related deaths. We cover under our policy the broad range of medical error and adverse outcomes that can occur in health care.

If the goal is to learn from these events in order to reduce the incidence of such events in the future, we must ensure that thorough analyses are conducted. Simply counting the events by itself does little to prevent future occurrence. Knowing what has happened is certainly interesting. It may even be useful if the information is complete, which is currently is not, but it is the "why" that will lead us to the solutions.

I would submit that if the true goal is to reduce errors, then any reporting something, whether mandatory or voluntary--and I agree with the quote earlier that mandatory at its root is still voluntary--any reporting system must be tied to first a requirement for in-depth systems analysis; second, Federal protection of the confidentiality of the findings from these analyses; and third, sharing of de-identified information with those agencies and organizations who are in a position to aggregate and analyze the data, to recommend solutions, and to monitor on a regular basis the response of health care organizations to those recommendations.

Over the last 2 years, the Joint Commission has actively pursued such protective legislation to bolster reporting and analysis of medical errors. When you consider the issue of disclosure, I would ask you to distinguish between the information about the event itself, which is generally discoverable, and the findings of the analysis of the event, which is what we seek to keep confidential.

I would like to conclude my remarks by observing that the work we are doing now concerning identification and response to errors and to sentinel events represents only a starting point. We should learn what we can from these efforts certainly and use that knowledge to move quickly into a proactive risk-reduction model where systems analysis and safe design anticipates rather than follows an adverse event.

Finally, I strongly believe that we will not have achieved the sustainable solution to the problem of medical errors until we develop a national curriculum in safe health care design that would be included in the education of all of our health care professionals.

Thank you very much for this opportunity.

DR. NIGHTINGALE: Thank you very much.

I believe that "M" as in Medical Device Manufacturers precedes "N" as in National Blood Data. One more chance, a show of hands. Let's do those two and then Dr. Linden and the lady, just to the speakers left.

MR. NORTHRUP: Thank you.

I am Steve Northrup, executive director of the Medical Device Manufacturers Association. We are an association of 130 companies based here in D.C. that represents the entrepreneurs in the medical device industry. We were created back in the early '90s by a group of executives of small- and mid-sized companies who felt that the entrepreneurs in the industry needed their own distinct voice in Washington.

You are probably familiar with HIMA, the Health Industry Manufacturers Association. We are not HIMA. We are focussed on the needs of the entrepreneurs.

As I am sure you know, most of the innovation in medical technology comes from small entrepreneurial companies. Clearly, your discussion of medical errors, I think our perspective bears on that discussion.

Technology can certainly play a role in reducing errors in blood administration. Technology when used, as intended, can play that role. The problem is when state-of-the-art technology cannot make it to the blood-banking and blood administration industries. That is when you have got a problem.

Our point of view on this--and you have our statement--is that this committee is in a perfect position to take a look at what the FDA is going and specifically what the Center for Biologics, Evaluation, and Research, or CBER, is doing or not doing to make sure that state-of-the-art technologies are on the market and available to the blood-banking industry.

As you may or may not know, CBER and the Center for Devices in Radiologic Health, or CDRH, at the FDA have an inter-agency agreement that allows or gives the authority for reviewing devices that are used in blood banking to CBER. There are probably about 60 devices a year that CBER reviews, but it takes CBER on average--and these are based on the latest statistics that I have--three times as long as it takes CDRH to review and approve or clear a device for marketing.

We would like you to take a look at this issue. We would like to see CBER return the responsibility for managing the review of these devices to CDRH. CDRH has been working since 1994 reengineering its own processes and implementing the reforms that are mandated by the FDA Modernization Act of 1997 to get their systems to a point where they are a being responsive and timely regulator, but it has taken us 6 years to get there.

I know that CBER has a device action plan, but frankly it seems like a lot of work, thousands of staff hours and untold dollars to reengineer CBER's processes to get to the point where CDRH is now. It has taken them 6 years, and I do not think any of you nor any of the consumers in this room in particular want to wait 6 years for CBER to get their act together to the point where they are a responsible and responsive regulator of the medical technology industry or at least those technologies that are used in blood banking.

So I would like you to look at this issue. It is important for medical technology entrepreneurs or scientists and health professionals and engineers who are trying to develop new technologies that will make blood banking safer, that will address some of the concerns that have been raised here. So I would like to encourage this committee perhaps at your next meeting to take a look at what CBER is doing and see if perhaps you would not agree with us that it makes more sense for the 60 devices a year that CBER reviews to transfer that responsibility to the Center at the FDA that has clearly taken steps to address the problems in its regulatory processes, rather than having to wait 6 years or maybe even more for the Center that is currently reviewing those devices to get its act together.

I appreciate the opportunity, and you do have my comments. Thank you.

DR. NIGHTINGALE: Ms. Sullivan?

MS. SULLIVAN: Good morning. I have provided a statement which I hope you will read, and I will summarize it at your request.

My name is Marian Sullivan, and I am the executive director of the National Blood Data Resource Center, which is the only existing organization dedicated to the collection, analysis, and distribution of data characterizing blood-banking and transfusion medicine.

Our data have been requested by this committee as well as by the Subcommittee on Oversight and Investigations of the House Commerce Committee, and at the suggestion and recommendation of this committee, we are now collecting monthly distribution data from a representative sample of blood centers in the United States to address the issues of the blood supply that concern us all.

In a few months, a similar hospital sample will be in place to enable the rapid collection of utilization data by NBDRC.

The NBDRC believes that no-fault confidential event reporting to a non-regulatory, non-accrediting organization would significantly increase error detection, reporting and prevention, and we firmly contend that such a program must be either mandatory, meaning required, or include sufficient financial incentives to ensure a high rate of institutional participation. Such a program should include adverse events and near-misses.

A centrally maintained secure database would be an invaluable research tool which would be readily accessible to other investigators.

The collection of coded and classified event reports from transfusion medicine should be the responsibility of an independent organization with an in-depth understanding of the terminology, standards and procedures of this complex specialty.

The NBDRC has the unique capacity to serve as a central repository for event reporting data for transfusion medicine for the reasons that I have outlined in my statement. We hope to have the opportunity to participate in the development and analysis of a reporting system for transfusion medicine.

Thank you.

DR. NIGHTINGALE: Dr. Linden?

DR. LINDEN: Based on some conversations last night and this morning with people, I would just like to clarify and elaborate some of the comments that I made yesterday.

Firstly, briefly, to clarify Jim AuBuchon and my conversation about the Statue of Liberty, we were referring to the fact that the Statue of Liberty is geographically in what should be New Jersey. Of course, legally, we all know it is in the State of New York.

[Laughter.]

DR. LINDEN: I was also asked about the cost of our program. I believe you were the one who asked me, and I gave some thought to that. The figure I came up with is probably about $150 per facility per year for what we do in my office in terms of tracking these events, assisting people with their corrective actions and so forth. These costs are passed onto the facilities in the form of the fees that we charge them.

That does not count the cost that the facilities themselves incur in the process of investigating their own events and reporting them to us, but the fact that they need to be reported to us is hopefully not much additional cost on their part because I certainly hope that these facilities all have quality programs where they are doing this, anyway.

One reason that we chose the format that we did of being very flexible in allowing people to submit their reports in a manner of their own preference basically relates to what Corey Dubin said, that even a mandatory system is ultimately voluntary, and we did want to facilitate compliance by making it easy for people. Therefore, we have tried to be flexible in what people report. So that what additional costs they may have related specifically to the reporting, I cannot asses, but they hopefully should not be too great.

I do think that if there is to be a mandatory system, we do need to keep that in mind and keep it from being too burdensome because, if it is too burdensome, people will not comply. We cannot be too overly complex or convoluted in what we ask or what we are expecting in a mandatory type of system. I think you may have a little bit more flexibility with voluntary systems, but then you may bias your participation towards the large and more sophisticated facilities.

Since I did mention that we see a higher rate of problems in the smaller facilities, we do need to keep in mind that it is these 100-, 200-bed hospitals that are really where we need to focus our attention, not the 1,000-bed hospitals, which are largely doing a fairly good job with their own quality improvement programs.

Lastly, I just wanted to comment and clarify on confidentiality and to distinguish that from anonymity. There has been mention of unlinked reports.

When I mentioned confidentiality and the fact that our reports are confidential, I mentioned that through legislation, we have exempted those reports from the Freedom of Information law, which would otherwise provide that these reports be discloseable.

So, therefore, while I may or may not receive patient identifiers, I may or may not receive staff identifiers, we do always receive facility identifiers. That is certainly very important to our work assisting the individual facilities.

In contrast, an unlinked system that would be completely anonymous, you would lose the ability, one, to look at things changing over time at individual facilities, but you would also lose the ability to focus on facility attributes that you may not have originally looked at.

For example, we looked at the size of the transfusion service. There may be other types of attributes of the facility that you want to look at that perhaps you were not initially collecting, but if you know the name of the facility, you can go back and collect those later. I certainly favor confidential systems, but I certainly agree that these reports do need to be confidential if you are going to encourage people to comply, be it a voluntary or a mandatory system.

Thank you.

DR. NIGHTINGALE: We have one additional person who wishes to comment, I believe.

MS. POZEN: Yes. My name is Ann Pozen, and I am the president of the National Association for Victims of Transfusion-Acquired AIDS.

I know that you all met all day yesterday and today, and the errors that you have been discussing are human errors that are related probably more to carelessness, maybe reading test results inaccurately, and other types of errors.

The errors that were made in the early 1980's regarding the blood supply were really errors of ethics, and although I do not know whether you have been discussing the issue of ethics over the past 2 days--I am sorry I was unable to make the meeting yesterday and could only make it late today--I think that any review process of errors in the blood supply must include some ethical review as well as a structure for identifying types of errors and quantifying those errors.

That is all that I really wanted to add. I did want to make our presence known. We are a new organization, and we are here. This is the first time we have been able to attend meetings in Washington, and we plan to be involved in the process as much as we can.

Thank you.

DR. NIGHTINGALE: Is there anyone else in the audience who wishes to make a public comment about any item on the agenda at this meeting?

I see none.

DR. CAPLAN: Let me try to lay out a work plan for the rest of the meeting.

Some of you have said because of the weather and bad conditions, either here or where you are going back to, that you really are pressed. I think what we will try to do is make sure that we keep the lunch to one hour, try and aim for, believe it or not, a 2:30 end time.

I asked Steve if he would try and come up with some recommendations for us to think about, if there are any--maybe there are not--that we wish to make at this time to talk about after lunch. So he is going to sit with his pencil and a piece of paper in the lunch room, and those who would like to be on the rump drafting committee are welcome to join him or lobby him as they feel appropriate.

Mac, you can gear up the old slide projector of overhead for the after-lunch experience. We will in fact have some sort of print-out to replace your rotten penmanship some day.

The other comment that I want to make before we leave here, it does seem to me we need to keep in mind the recommendations that we have some progress made. We have heard a lot from different organizations and settings about detecting error and responding to it, systems in place that people are using. So, in the blood world, unlike some other areas where error has become an issue, there are things to build upon.

Secondly, the committee knows that micromanagement is a very dangerous thing. So large-scale directions to go toward are in some ways easier for us than getting specific about how to implement things. That is probably going to take a little more back-and-forth.

The last comment I would make is to get at the liability lawsuit phenomena. If we are going to really have a system in place, I think what this committee should do is figure out what it really thinks is important for identification and analysis and response to error. We do not have to solve the liability compensation issue here. So what I would rather see us do is approach this with the attitude of what would we like to know, what would be good to know, then maybe make some comments about how to get that rolling with respect to confidentiality or privacy or anonymity or non-identifiers.

It can be done in looking at this issue that we start by collecting data and make that the basis for trust and then move onto a discussion at some day in the future about how to disseminate information, but if we do not think we have got enough now, then the first goal is to get it and to accumulate it or to build a system that will structure it. Then you can decide what you want to do about releasing it or disclosing it, but if we are not going to get any information, there is nothing to release and disclose, and there is no compensation, liability, or anything else to talk about.

So I would rather see us decide what we think we ought to get, not get bogged down in fights about privacy, confidentiality, and liability, which will flow out, anyway, and I might add are probably beyond our control because Congress, like it or not, is going to go in these waters. They may set some policies about what is going to happen there that we just are not going to be controlling, but what we can control is recommendations on what to collect, what to do with it, what the scope is, how we like to see it standardized. So that is the spirit with which I hope we can approach this after lunch.

That is the end of my soap-boxing. Why don't we meet here at 1:00

[Whereupon, at 12:03 p.m., a luncheon recess was taken, to reconvene this same day, Thursday, January 27, 2000.]

- - -

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

[1:12 p.m.]

DR. CAPLAN: I think where we got during the lunch break was four proposals that we'd like to present for the Committee's deliberation. I'm not ready to put them forward as motions yet, but just something to think about. There's only four of them. That doesn't mean there can't be more, but I'm going to ask Steve to read these even before we start writing them up on any displays yet, just so you can get a sense of what the lunch discussion produced.

DR. NIGHTINGALE: The first suggestion is that quality assurance programs in transfusion--

DR. CAPLAN: Mic, your mike is on?

DR. NIGHTINGALE: Sorry. The first suggestion is as follows: "Quality assurance programs in transfusion medicine should capture, analyze and respond to data on errors and accidents that do not cause actual harm with the same effort and vigilance applied to errors and accidents that do cause harm."

Number 2: "The experience of aviation and other industries supports the use in transfusion medicine of a confidential non-punitive system for the management of errors and accidents that do not cause harm."

Number 3 is the first ABC recommendation, "That FDA extend the current error and accident reporting requirement to apply to all blood establishments and hospital transfusion services rather than only registered blood establishments."

In recommendation number 4: "Industry and government should be encouraged to facilitate the evaluation and implementation of devices that promise to prevent misidentification of blood products and/or patients."

Those are four broad topics.

DR. CAPLAN: Does the Committee think those four are worth going through, looking at, using as a basis of discussion to get us going?

Okay. Why don't we then see if we can talk about the one that you all have in front of you which you gave as ABC 3, I think, but since that one's written down and--

DR. NIGHTINGALE: But could we start since--there is a certain logical flow here. I'd like to--yes.

DR. CAPLAN: Okay. Then let's start with what is proverbially known as 1. Would you recap that, the gist of it, Steve? That's the one that says we treat non-harmful errors with the same verve that harmful ones are treated.

DR. NIGHTINGALE: Roughly.

DR. CAPLAN: Jim?

DR. AuBUCHON: I realize we may not have verbiage here yet, but my perception of Number 1 was in essence a quality assurance system, quality improvement system, designed to detect and fix problems. Am I understanding this correctly?

DR. NIGHTINGALE: No. I think that you're calling Number 1, we're calling Number 2. What we're starting out with is a statement--our response to the idea of voluntary--or reporting an analysis of near misses as well as direct hits.

DR. AuBUCHON: Is Number 1 pertaining to an internal system within each blood establishment, or are we talking about an external reporting system?

DR. NIGHTINGALE: That's down the road.

DR. AuBUCHON: I gave you an either/or, Steve.

DR. NIGHTINGALE: Yeah. Neither. No. The question is, we had a day's worth of presentations about the relative merits of analysis of near misses. Is that concept a guide to our future deliberations? Is that where we start or do we start from somewhere else?

DR. AuBUCHON: Okay. So this, the first item up here is really just sort of a God-motherhood-and-apple-pie sort of statement, that we think near misses are important?

DR. NIGHTINGALE: God, motherhood, apple pie and aviation safety, yes.

DR. AuBUCHON: Okay, thank you.

DR. CAPLAN: I can suggest that what we're trying to say here is that existing quality assurance programs should capture, analyze and respond to--if you want it to turn a little more prescriptive, what we're saying is where the programs exist, they've got to reach out to extend to this. That's building--that would be a building on statement.

DR. AUBUCHON: Well, I certainly am not going to argue against God, motherhood, apple pie or aviation safety, but I would take step number 1 a little bit further, and propose that we recommend that a quality assurance system that does these things be implemented in every transfusion service. We could say all blood establishments. They already exist in blood centers, but that we try to bring that out internally.

DR. NIGHTINGALE: That is Number 3, or that's going to be Number 3.

DR. AuBUCHON: No, Number 3 talks about reporting. I'm talking about an internal quality assurance system within each blood establishment, to capture, analyze, and remediate problems.

DR. NIGHTINGALE: Then I think that should be number 2-1/2. I think that's a separate idea.

MS. O'CALLAGHAN: Excuse me, Dr. Nightingale. I would like to comment on this first point in focusing on incidents that cause harm versus those that do not cause harm. The reports--the errors and accidents that are reportable to FDA in most cases don't cause harm, because a lot of them have not actually been transfused, okay? So, I would hesitate in putting that focus on harm versus no harm. You know, if you change that to errors--you want the near misses to be identified as those that do not impact at all on product or patient. You know, use the word like "impact" as opposed to "harm." And as opposed to "the reportable types of errors and accidents that may impact on products or patients."

DR. NIGHTINGALE: That is correct, but that is--I understand the statement, but your statement identified precisely what the issue before this Committee actually is. What Mr. Francis' exposition yesterday touched on at least peripherally was the use--the analysis and the disposition of reports of incidents that did not cause actual harm. As you point out in your handout and elsewhere, the near misses right now are reportable to FDA, and our first question is, is that where we want to continue to go?

MS. O'CALLAGHAN: Yeah. We know that there's going to be probably some changes in the final rule as far as what's reportable, but we will--I'm almost positive we will still be getting some of what would be considered to be a near miss because it wasn't actually transfused, okay? And we certainly will be getting reports of situations where products were actually transfused, but there was no harm to a patient. I just have a little problem with the distinction of harm versus no harm.

DR. NIGHTINGALE: And that's for the Committee to determine, but I think you've done us a great service by crystallizing just what the issue is in the first question. And this helps me respond to Dr. AuBuchon as to why did I want motherhood, apple pie and aviation safety in Item 1, and I want it there because it's, I think, the most critical issue before the Committee today.

DR. CHAMBERLAND: Just a follow-up to Jim AuBuchon comment, kind of a clarification. Number 1, as I understand it, is predicated--as I read it at least, it's predicated on the existence of a QA program in transfusion medicine, that that's there first, and you want this additional information that we're currently going to discuss be captured. If I understood what Jim said correctly and Karen Shoos Lipton said yesterday, I don't believe all transfusion medicine programs currently have a QA in place. Is that correct?

DR. NIGHTINGALE: Dr. Epstein, do all registered programs have a QA system in place?

DR. EPSTEIN: Well, FDA did issue a guidance--I believe it was in 1994--which made clear the expectation by the regulator that all blood establishments should have a QA program, and we identified what we thought were the critical control points. So from a regulatory point of view this should be in place.

Now, what you could ask is how well developed is it across the board? And you'll find that there's variation. But certainly we already regard that as a regulatory requirement.

DR. NIGHTINGALE: Sure. And, Dr. Epstein, as a follow-up, is that not one of the leading motivations of those who would extend registration to currently unregistered establishments, that a quality assurance program of some sort be made mandatory?

DR. DAVEY: Steve, maybe we could around this and respond to the comments from the FDA, and just put a period after "accidents" in the third line, and get away from all this stuff about actual harm and possible harm.

DR. NIGHTINGALE: I don't--the whole point of the first day was to address rather than to get away from that point.

DR. EPSTEIN: Well, my suggestions would be to edit programs in transfusion medicine to say "all blood establishments." And then I would say "should respond with equal vigilance to data on errors and accidents independent of whether the units were distributed or there was a clinical adverse effect." In other words, that captures the notion of near misses without creating any conflict with the existing reporting system, just calling for equal vigilance.

DR. NIGHTINGALE: There's two ideas that on, "blood establishments" means something very specific in regulatory parlance, and something less specific in plain English. Do you wish to say "blood establishments" or "blood establishments and transfusion services?"

DR. EPSTEIN: Well, in regulatory parlance transfusion services are blood establishments. They are subject to all FDA standards. It's only that the oversight, in terms of inspections is through HCFA, but the standards are those which are promulgated by the FDA.

The nuance with respect to registration is that we register all establishments that are engaged either in blood collection of further processing. We do that independent of whether they are intrastate or interstate. However, the interstate establishments furthermore require licenses. Okay? So I mean, unfortunately, this is technical in its jargon, but it would be correct to say: "Quality assurance programs in all blood establishments (understood to include transfusion services) should capture, analyze and respond to data on all errors and accidents, independent whether the products were distributed or whether the patient had an adverse effect."

DR. NIGHTINGALE: Should we re-edit the first sentence as Dr. Epstein has suggested? Seeing no objection, Jay, would you watch that we get it right?

DR. EPSTEIN: Yeah, I will write it down.

DR. CAPLAN: While we're looking at that, not to get technical about it, but 2 is probably the preface; it doesn't recommend anything, it just states a fact, so while I doubt anybody will oppose it, we might just make that the--would you be amenable to moving that into the lead to the recommendations?

DR. PENNER: As a lead-in to the rest?

DR. CAPLAN: Yes. Does that seem okay, that we sort of preface the recommendations here that we look elsewhere? This sort of supports it, so that becomes the preface?

[Pause.]

DR. CAPLAN: Make sure you're hitting your microphones, and we've got the "W" is going to go as soon as she transfers that. We'll make a dead "W." The technology has raised expectation I see among the Committee. Don't forget to use your mics, by the way. Use your mics if you're talking. All right.

So let's come down to show off 2 again while we're there. Let's look at 2, because I think, one, it's going to generate a whole lot of trouble.

DR. NIGHTINGALE: We're waiting for Dr. Epstein.

DR. CAPLAN: All right. How about we take a look down at 3 then?

DR. NIGHTINGALE: We're waiting for Dr. Epstein, and once we get Dr.--

DR. CAPLAN: Fernando, you want to get in on this Number 2?

DR. GUERRA: Yeah. I--

DR. CAPLAN: Hold on, hold on, hold on. Let's keep this now to the Committee, Committee talk.

DR. GUERRA: If he could just bring it down a little bit, the lead-in, the first sentence in 2, where we talk about blood establishments, quality assurance programs in all blood establishments should capture, that is quite restrictive, I think, because that implies just those centers that have as their main work something to do with blood, but how about blood establishments and/or centers that administer blood and blood products?

DR. NIGHTINGALE: As I understood the previous discussion that I had with Dr. Epstein, "blood establishments", the words, incorporate the concept that you--the institutions you were discussing.

DR. GUERRA: I guess it would be very helpful to know what is in their list then of blood establishments, because I'm thinking of some of the free-standing ambulatory surgi-centers, some of the free-standing plasma centers.

DR. NIGHTINGALE: Dr. Epstein has dealt with that. We added "blood establishments and transfusion centers" to the language in parentheses. It will be up in just a minute. So watch the screen and see if we have addressed your question.

[Pause.]

DR. GUERRA: But I think that still misses that other group. I mean, "collection centers, transfusion"--Dr. Epstein, does that cover, for example, the free-standing surgi-centers where a lot of blood is transfused, because they're not recognized as transfusion centers. People don't expect to be transfused in many instances, but because of problems they do have to get transfused. I mean, that limits it to collection and transfusion services, and I just wonder if we shouldn't include the other places?

DR. PENNER: "Centers that provide transfusion services."

MS. O'CALLAGHAN: Actually, what is meant by transfusion service is a facility who performs some type of manufacturing, which would be compatibility testing typically, so some of those places--like if it was a dialysis center that does some type of transfusions, would not be considered, under the "transfusion services" as part of a blood establishment, according to FDA.

DR. GUERRA: So is it possible for us to expand that to include some of those?

DR. NIGHTINGALE: What would that wording be, Fernando, that would--

DR. AuBUCHON: I have a suggestion in that regard. Because it's really blood establishments that are connected to the FDA and listen to this kind of discussion, in that we have a way of getting them to, I would suggest that we leave this Number 2 directed to blood establishments, but make sure that in the--after the parenthetical statement there, we include not only those errors and accidents or incidents that relate to what goes on within the blood establishment, but include all activities related to the transfusion event. In other words, make the transfusion service responsible for investigating, analyzing, responding to incidents that happen outside of its four walls, but that relate to transfusion safety, including collection of samples for pre-transfusion testing, and transfusion of the units. That would then empower the transfusion service to investigate all the way through to transfusion in a free-standing surgi-center, if that's where the error actually occurred, and make them, in essence, responsible for including that in their entire quality assurance system.

DR. NIGHTINGALE: Should that be in this resolution or in a separate one? This one's getting long.

DR. GUERRA: I think it could be stated as a separate one, because I believe it could be a special case in what we hope to accomplish for early recognition of some adverse event, and a system that can pick it up, and follow up, and investigate it.

DR. CAPLAN: Let's take that one, just a little more comment on this Number 2.

DR. PENNER: We still need something--center on the verbiage, it's still off. "Both blood collection centers and transfusion services." It would be in "facilities that provide transfusion services."

DR. CAPLAN: You want the words "facilities that provide?"

DR. PENNER: "And facilities that provide transfusion service." Otherwise it doesn't fit. It's just collection centers and then transfusion services. What's a transfusion service?

DR. CAPLAN: All right. "Facilities that provide."

DR. NIGHTINGALE: Dr. Guerra, does that address your concern?

DR. CAPLAN: That actually picks up Fernando's point if you write it that way.

DR. NIGHTINGALE: Yes, yes. Is that--from the FDA perspective is that--

DR. EPSTEIN: Well, we have one remaining technical problem. You see, technically, the way we define "reportable errors and accidents", they cannot include near misses, because they only exist for us if the unit was made available for release. I understand, it's just that "error" and "accident" is being used with a somewhat different meaning in this text versus FDA text.

DR. NIGHTINGALE: That's correct, and there--while there is overlap, there is not complete overlap between what we're talking about and what the FDA regulates.

MR. WALSH: Is it inappropriate to use "incident" instead of "accident?"

DR. AuBUCHON: The issue that Jay raises is one reason that I had suggested the phraseology which--is not perfect--that the system should investigate, capture, so forth, "all deviations from expected practices and outcomes."

DR. NIGHTINGALE: "All deviations from expected practices and outcomes?" Dr. Davey is nodding. Should we substitute "errors and accidents" with "all deviations from expected practices and outcomes?" There's a nod.

DR. CAPLAN: We could add it.

DR. NIGHTINGALE: There's a nod around the table. And strike "errors and accidents?"

DR. PILIAVIN: Take it all out from in front of "expected."

DR. CAPLAN: And then just leave it? Let's keep it in.

DR. PENNER: Instead of "deviations" could you use "all approved procedures" instead of "expected?"

DR. NIGHTINGALE: What's the next word? Who has--

DR. CAPLAN: As well as "errors and accidents."

DR. NIGHTINGALE: Why are you leaving that in? This is the time to comment.

DR. PENNER: I think you still need "approved procedures" because "expected outcomes" just kind of floats very broad. And you already have "approved procedures" in your laboratory and in your nursing manual and all of these things that are already involved in hospital management. So all you have to do is refer to those, and these have been passed by that hospital committees as being accepted and approved standards of procedure, as opposed to just outcomes.

DR. PILIAVIN: This is just editorial. It's nothing final.

DR. CAPLAN: Other comments? We're staggering toward something here.

DR. CHAMBERLAND: Just a point of clarification. As I understand it, "blood establishments" would include plasma collection centers? Okay. Do you think that that should be--to be totally clear--presuming that most people reading these recommendations don't do it with knowledge of what many people at the table know to be accepted regulatory language. Maybe we should just spell it out because--"in all blood and plasma establishments", or "i.e., both blood and plasma collection centers", something like that? Just put the word in, plasma, so there's no question that there is--

DR. NIGHTINGALE: Or "blood and plasma collection centers", Mary?

DR. CHAMBERLAND: Yes, in that parenthetical statement.

DR. GUERRA: I think it would also be helpful to reference the FDA regulatory document that may be without the specifics of that, and in that one could almost footnote some of these specific issues.

DR. CAPLAN: We'll make a note of that. We can do that later. I understand what--you're just cross-citing to.

DR. NIGHTINGALE: Dr. AuBuchon?

DR. AuBUCHON: Well, if I could follow up a bit on Fernando's point, and Mary brought this up earlier as well. Two-thirds of the transfusion facilities, transfusion services in this country are not members of the AABB, and although I would like to think that every member of the AABB has all of this included in their quality program, admittedly, they vary in the extent to which their individual quality programs do address it--at least they have something. But at least two-thirds probably have very little if anything related to this, and the drop-off of some members of the AABB, because of the AABB's insistence of the presence of this kind of program, and the objection of many of these institutions to this kind of approach, tells me that many of them are not reading what the FDA has been sending out, and do not believe that what the FDA has to say applies to them.

This also has to be taken in light of the data from Dr. Linden, that the smaller the facility, the greater the risks of some of these errors. Therefore, I think we should be very clear that we're talking about something that needs to be in place in every transfusion facility.

DR. NIGHTINGALE: In that case would you care to add, after "provide transfusion services", comma, "registered or otherwise?" That's the place you put your qualifier, and what qualifier do you want?

DR. GOMPERTS: Steve, I like that. I think we should add "registered and non-registered."

DR. NIGHTINGALE: There's a vote for registered and not. Dr. Chamberland?

DR. CHAMBERLAND: I didn't raise my hand to vote, but the comment is--I'm just wondering--especially since Number 2 is getting a little lengthy, whether before Number 2 we should have a separate recommendation that basically states what Jim just articulated, namely "blood and plasma collection centers and facilities that provide transfusion services should have in place QA programs." And then either same recommendation, new sentence: "These QA programs should capture, analyze, respond", but because I still see this as presuming that it's already in place, it's just not collecting enough data, and what we're hearing is, it's barely in place if in place at all.

DR. CAPLAN: I want to second that. I think we can say that they should have quality assurance programs in place. I don't think--I don't even know if we need to take the time to put that one up there now, if we can get agreement just one--actually, get a motion. We'll use the language that is appearing faster than I think it can, but it's basically saying "All blood collection facilities and establishments should have quality assurance programs in place." Got a motion about that?

DR. AuBUCHON: So moved.

DR. CAPLAN: Second?

DR. HOOTS: Second.

DR CHAMBERLAND: Don't you want to have "whether registered or unregistered" in there?

DR. CAPLAN: You can even use that language too; that's fine with me. And we'll just make that recommendation 1 discussion, because the other thing is a preamble, remember.

DR. GUERRA: I guess I would certainly support the notion of registered and/or unregistered, but we need to be sure that it is not interpreted as being licensed or unlicensed, and I don't know what the state statutes are for licensure, but I guess--and maybe, Dr. Epstein, is that a requirement in most of the states, that there has to be some licensure procedure for--

DR. EPSTEIN: No. Most states do not have licensing in place. The federal government requires a license to collect with the intent to ship in interstate commerce. States vary a great deal whether they have any further licensing process, and except for just a handful, most do not.

DR. GUERRA: But that doesn't preempt being registered or unregistered. They can be unlicensed and still be registered.

DR. EPSTEIN: Well, FDA requires that establishments that are engaged in collection or further manufacturing, say, making a plasma and a platelet or a red cell component, must be registered. Now, that's true whether they are an entity in a hospital or a free-standing community blood bank. If they're engaged in collection and processing, they must be registered with FDA. If they are only engaged in cross-matching, storing and distributing, which is really what transfusion services are, then they must be registered with Healthcare Financing Administration. They are, however, captured by all FDA standards.

DR. GUERRA: It's very complicated.

DR. EPSTEIN: Yes.

DR. CAPLAN: Well, I like--on Number 1, my comment would be that I believe in "all" as a very nice word, so I'm going to call a vote on 1. No, 2. Excuse me, Number 2. All in favor of Number 2?

DR. EPSTEIN: Could I make a technical comment first?

DR. CAPLAN: Yes.

DR. EPSTEIN: I'm not happy with the word "approved." I think it would be better to say "established procedures" than "approved procedures", because it begs the question of who approved them and under what mechanism. We're talking about--I guess 2 became 3?

DR. CAPLAN: Yes.

DR. EPSTEIN: I'm sorry.

DR. NIGHTINGALE: Should we vote on 1 first?

DR. CAPLAN: 1 is the preamble just passed.

DR. EPSTEIN: What's 1?

DR. CAPLAN: Don't worry about that.

DR. NIGHTINGALE: Aviation.

DR. CAPLAN: Aviation safety--I know you want that aviation safety thing in there.

DR. NIGHTINGALE: No. What I want is documentation in the record that the Advisory Committee has approved it.

DR. CAPLAN: All right, let's do 1.

DR. EPSTEIN: But we haven't discussed 1.

DR. CAPLAN: No, no, I mean I'm ready to open up the floor for 1. We can comment.

DR. PILIAVIN: "Aviation" should not be capitalized.

DR. CAPLAN: Discussion?

DR. GUERRA: I guess I'm concerned about the use of "transfusion medicine" as almost a specialty or--this group probably understands it, and those that certainly work within the industry, but that puts it at a different level. I'm concerned.

DR. NIGHTINGALE: I think the follow up of what you're suggesting would be to strike the words "in transfusion medicine" and add the word "medical" before "errors and accidents." Is that what you wanted to do?

DR. PILIAVIN: I don't think we can talk about "medical" in general, not in this Committee. If you took out "transfusion medicine", then all you'd have left is "medical", and we can't tell them what to do in other areas of medicine, can we?

DR. NIGHTINGALE: I would reserve comment on that, but I understand what Dr. Piliavin is saying.

DR. HOOTS: I think we can. I mean, we're not directing anything anyway. This is just a preamble, it's a statement.

DR. NIGHTINGALE: What's the sense of the Committee?

DR. PILIAVIN: Are you suggesting we just take out "transfusion" and leave in "medicine?"

DR. HOOTS: Yes.

DR. NIGHTINGALE: The suggestion is that the recommendation of the Committee be broadened beyond the scope of its charter.

DR. PILIAVIN: Okay with me.

DR. NIGHTINGALE: There are heads shaking around the table.

DR. EPSTEIN: I would suggest you leave some reference to transfusion medicine. Whatever you want to call it, I think we ought to be restrictive.

DR. NIGHTINGALE: In that case, is there a sense that the resolution as it stands reflects the sense of the Committee?

DR. CHAMBERLAND: Perhaps to get around this issue, do we need to think about being consistent with the wording that we use in each of these recommendations? We just struggled quite a bit of time ago developing this language about blood establishments and what they were. Is not that the same entity that we're referring to here in recommendation 1, supports the use of a confidential non-punitive system in blood establishments that we defined below. So instead of going down--coming up with new terminology, should we just be consistent?

DR. NIGHTINGALE: Yeah. I'm going to suggest that for the purposes of a recommendation of the Advisory Committee that this is close enough to the sense of what we want, that you could go with this without causing harm to the system or constraining anything that you wanted to do in the future. And you might want to look and say, "Is this close enough?" And we move on.

DR. CAPLAN: And it seems to me what we'll have in front of this is a set of presentations and discussions about error in medicine anyway, so there's a sort of silent preamble here, so the best focus for us I suspect is to keep the transfusion emphasis there for now.

DR. PILIAVIN: I mean here we're talking about things that happen in hospitals that aren't necessarily in some of these other establishments, aren't we?

DR. CAPLAN: Right.

DR. GUERRA: I would move the "transfusion" to the end of that, "supports the use in medicine of a confidential non-punitive system for the management of errors and accidents that do not cause harm and are related to transfusion of blood and blood products."

DR. NIGHTINGALE: I would like to keep as few words as possible here.

DR. PILIAVIN: Yes. I like the wording the way we have it.

DR. NIGHTINGALE: Do we have a motion?

DR. PENNER: So moved.

DR. CAPLAN: Second?

MR. WALSH: Second.

DR. CAPLAN: All in favor? Opposed?

[Show of hands.]

DR. NIGHTINGALE: We have opposition to 3, and it may be worthwhile listening to that opposition, because I thought when we proposed the motion that we had unanimity.

DR. GILCHER: I had my hand up to make a statement, and was not recognized.

DR. CAPLAN: Oh.

DR. GILCHER: Before the vote.

DR. CAPLAN: And you're still not. Who's got objections?

[Laughter.]

DR. CAPLAN: Anybody with an objection?

DR. GILCHER: Yes, I object.

DR. CAPLAN: Okay.

DR. GILCHER: I believe--I support what Mary Chamberland said, and if in the first paragraph one said: "The experience of aviation and other industries supports the use in all blood establishments", and then put the parenthesis that has "both blood and plasma collection centers and facilities that provide transfusion", and put a parenthesis, then you have defined "blood establishments", and no longer does that need to be said in the rest of the resolutions.

DR. NIGHTINGALE: So that that would be an amendment to the resolution we just passed to--that's an editorial amendment.

DR. GILCHER: Yes.

DR. NIGHTINGALE: I think we can do that. Dr. Chamberland, does that address your concern?

DR. CHAMBERLAND: It does, but I didn't have a chance to put forward another concern, and I think Jay has a concern.

DR. NIGHTINGALE: Could we stick to this concern before we to another one?

DR. CHAMBERLAND: Yes.

DR. NIGHTINGALE: Dr. Epstein, do you have residual concerns if we make the editorial change that Dr. Gilcher just suggested?

DR. EPSTEIN: I agree with Dr. Gilcher's proposed change. My further concern is once again we have to clearly distinguish the fact that FDA's definition of "error and accident" precludes the notion that it caused harm. In other words, it's logically inconsistent with existence parlance.

DR. NIGHTINGALE: That's true. It's logically inconsistent with existing FDA parlance, but we're somewhat--this Committee goes beyond FDA parlance.

DR. EPSTEIN: But this Committee has not defined "error and accident."

DR. NIGHTINGALE: We have a transcript, and we have common language. I think that--

DR. CAPLAN: Well, but for preamble purposes, we can probably get the spirit without the definition there. This is just a warm-up, I suspect. Fernando?

DR. GUERRA: No, I would certainly support Dr. Gilcher's suggestion. I can live with that. But somehow I would still like to see the notion tied to medicine and the practice of medicine.

DR. CAPLAN: Dave?

DR. KUHN: Art, are we going to be voting on these seriatim or is it going to be in total?

DR. NIGHTINGALE: No. I think that we really need to get the language seriatim, so that what we--what I really need is a set of recommendations that truly reflect the majority if not the unanimity of this Committee. If we get them, we can do something with them. If there is confusion after the a whether the recommendations actually reflect the majority or unanimity, then they go nowhere.

DR. KUHN: The reason I ask that question is because--you know, as I'm sitting here thinking that we're crafting recommendations that could have all-time effect on reporting errors and incidents, I can't help think that someday this transcript of this Committee could in some way, shape or form, be cited as a moment the government is either taking a more rigorous or a less vigorous position on safety requirements. And, you know, what I'm thinking is I would like to make sure that when we do this, we're doing the right thing, and that we're trying to encapture everything at the best possible avenues.

DR. NIGHTINGALE: Well, the tape is running as those policy recommendations are evolving. I would assure you that this is not the last word on the subject, and I think it would look much better if we recognize that this may be one of the first words.

DR. CAPLAN: Mary?

DR. CHAMBERLAND: Perhaps as a way to address Fernando's concerns, which I share as well, in that I think it's appropriate for the Committee to be focusing on errors, near misses, whatever in transfusion medicine, because that's our charge. But we recognize that that's only one piece of a much broader, larger problem that the IOM report and others have highlighted, so perhaps in this introductory preamble, we could--language could be crafted which basically states just that, that we--you know--

DR. CAPLAN: I actually have something that Ed gave me--hold on--

DR. CHAMBERLAND: Because also where I'm going with this is I think we need to consider that the systems, the reporting systems or whatever that are developed for accidents, near misses in transfusion medicine, may actually--I think a lot of thought has to be given as to whether these are stand-alone, are these part of a larger, comprehensive system of which one piece is transfusion medicine, et cetera? So--

DR. NIGHTINGALE: Mary, may I suggest that while we're not obligated to limit ourselves to transfusion medicine, we might look better if we take care of transfusion medicine first, and at the conclusion rather than the initiation of our recommendation, we recommend that these be applicable to other areas of medicine.

DR. CHAMBERLAND: I wasn't suggesting this be a recommendation. I was suggesting that this be sort of introductory language, that we recognize that transfusion-related errors are part of a whole larger--

DR. CAPLAN: Let me read something that Ed prepared for me. "Given the fact that the cost of health care and access to health care has received much attention with considerable consequences and changes of health care delivery, it's appropriate now to focus on error and accidents arising out of health care delivery and the changes that have and are occurring. Therefore, we are recommending that all branches of government associated with health care and its delivery be focused on error and accident in health care delivery, including blood administration or transfusion practice."

Something like that is what you're looking for to set it up. We have something like that. And let me suggest that that we can probably craft pretty easily to lead in here. That's the spirit of what you're looking for?

DR. NIGHTINGALE: Yeah. They have reference to the experience of aviation.

DR. CAPLAN: There's that. I don't think we have to do that right now, but we'll craft that into the setup. I understand what you're hunting for. Thanks.

DR. EPSTEIN: Yeah. I'd like to come back to trying to fix FDA's problem. I think that the simple fix is to say "management of near-miss errors and accidents", because what we're confounding here is what was called a near miss and what was called a benign event. FDA requires reporting of benign events. If you give the wrong blood group type, but it was compatible with the recipient, that's a benign event, that's a benign error. FDA doesn't really wish to be told that we have to have a confidential non-punitive system, because we currently have a system which is not confidential, it is accessible under FOIA, and, you know, you can debate whether it's punitive or it's friendly correction, but I think it would be problematic to be advised that we have to change that system right now. A simple fix would just be to say "a confidential non-punitive system for the management of near miss", and even put it in quotes, "errors and accidents." That creates the break point which is consistent with the existing system, because we don't currently request reporting of near misses. Indeed, we don't even define them as errors and accidents.

DR. NIGHTINGALE: That's understood, but I guess the question then before the Committee is, is the principal imperative to stick within the current system or are we recommending changes?

DR. EPSTEIN: Well, that's fine with me for that to be debated, but you see, it's being buried in the language rather than being debated. In other words, if it's the thought of this Committee to stop reporting of benign incidents and move that into the confidential, quote, unquote, "non-punitive system", that's a pretty big change, and it ought to be mindful, not just accidental due to change of language.

Again, I would suggest that the framework for this distinction is simply to make this point refer to the near miss.

DR. NIGHTINGALE: Well, that was the point of having the Committee meeting in the first place, so let's debate it.

DR. HOOTS: It seems to me that we should be able to get at this issue on the broader sense, and getting back to what Art said before lunch, I'm not sure that we should actually answer that question definitively today. I think we should write this in such a way that what works out to be the best system overall after more perusal than just our two days actually comes into play.

So I would vote for language that does not grant necessarily what Jay wants in terms of preservation of present policy, but on the other hand, doesn't necessarily cause it to be overturned either. But says that we want this to happen, and we want it to happen most expeditiously and that we'll leave the logistics of the language to be played out by people who have to deal with that on a day-to-day basis.

DR. NIGHTINGALE: In that case, does the language that's up there right now that has "near miss" and in quotation marks, address your concerns?

DR. HOOTS: I think it probably does. I'd like some other committee members to comment about it, though.

DR. DAVEY: Certainly "near miss" is clearly vague and ill-defined right now, and I think we have to be careful how that evolves. I mean, what is a near miss? Are we going to put that language in there now with that degree of "vaguery"?

DR. NIGHTINGALE: That's what we're asking.

DR. DAVEY: I would suggest no.

DR. NIGHTINGALE: And you would suggest instead?

DR. DAVEY: To leave the language as it was before Dr. Epstein's editorial.

DR. NIGHTINGALE: Jay?

DR. EPSTEIN: Another way to clarify it would be to say, "For the management of errors and accidents not currently subject to regulatory reporting." Then you also have no conflict, and you didn't have to define it.

DR. NIGHTINGALE: There's a lot of nodding of the head around the table, "The report of errors and accidents that is not subject to current regulatory reporting requirements."

DR. HOOTS: Can we then, not on this one, but later on down when we talk about error reporting, get a little more specific to make sure we include the concept of "near miss"? For people reading this who don't know FDA regulations, I want to make sure that concept is included, but it doesn't have to be included here.

DR. NIGHTINGALE: "Near miss" is out of here.

DR. HOOTS: Right.

DR. NIGHTINGALE: So we'll address that issue when it arises. If the words "near miss" come back into subsequent regulations, then we can address it at that time.

Mary?

DR. CHAMBERLAND: I'm ready to move on to another word issue in number one, if you're all ready.

DR. CAPLAN: Any more on this?

DR. NIGHTINGALE: Let's stay right here.

DR. SNYDER: I've got a quick question. Why are we hung up on the words "errors" and "accidents"?

DR. NIGHTINGALE: Because this is a really important concept.

DR. CAPLAN: All right. I guess what I'm going to try and do is drive this forward. So let's hear another wording concern.

DR. CHAMBERLAND: Yeah. The other wording concern is it speaks to the initiation of a system for "management." But doesn't the system also have to have a reporting component previous to management? I mean, first, you have to collect, so you have to have collection, reporting, analysis and management.

DR. NIGHTINGALE: That's the next recommendation right now. Recommendations that go more than two sentences really don't work. If you've got an idea, put in one sentence at a time, and it'll be much easier to carry down the regulatory road.

DR. CAPLAN: Actually, what you're talking about I would say is subsumed under the concept of management here, just for the opening thing. I understand what you're asking about reporting, but that's what I would call managing error.

Jay?

DR. EPSTEIN: Could I just suggest that instead of saying "current regulatory practice," we simply say "regulatory requirements." The reason is that they are also evolving--

DR. NIGHTINGALE: Understood.

DR. EPSTEIN: Take out the word "current" too--just "regulatory requirements." That basically says there should be no gap.

DR. NIGHTINGALE: Yeah.

DR. CAPLAN: Call this question for a friendly amendment of our previously passed motion, in somebody's bizarre parliamentary principles. So we are going to amend our language slightly.

A second to that motion?

DR. HOOTS: Second.

DR. NIGHTINGALE: May I read it into the record? "The experience of aviation and other industries supports the use in all blood establishments [i.e., both blood and plasma collection centers and facilities that provide transfusion services] of a confidential, nonpunitive system for the management of errors and accidents not subject to regulatory requirements."

DR. CAPLAN: Jim?

DR. AuBUCHON: We previously had registered and unregistered before the close of the parenthesis, but those disappeared. Did we want--

DR. CAPLAN: After "transfusion services," he means, there was a comma, "registered and unregistered."

DR. NIGHTINGALE: Should we introduce "registered and unregistered" or does Dr. Epstein's--could we see some nods?

DR. CAPLAN: Let's not introduce it here, in the interests of spicy, dynamic language.

DR. NIGHTINGALE: Then, is number one a go?

DR. CAPLAN: All in favor?

[Show of hands.]

DR. CAPLAN: Opposed?

[No response.]

DR. CAPLAN: Number two?

DR. NIGHTINGALE: The amendment to number one passed unanimously.

DR. CAPLAN: So we're up to, "All blood establishments should have an established quality assurance program."

DR. HOOTS: Can we just take out "established"?

DR. CAPLAN: Uh-huh, and we could substitute for that "an incredibly good"--

[Laughter.]

DR. CAPLAN: Discussion?

DR. GILCHER: The reason I had said about number one was so we could remove "that is" because we've defined blood establishments in number one and just shorten number two.

DR. CAPLAN: Other comments? Motions?

DR. PILIAVIN: Don't we have to put the "registered and unregistered" back in one?

DR. CAPLAN: Yes, that's going to zip back in there.

Give me a motion.

DR. GUERRA: So moved.

DR. CAPLAN: Second?

MR. WALSH: Second.

DR. CAPLAN: Favor?

[Show of hands.]

DR. NIGHTINGALE: Proposed was Guerra, second was Walsh.

DR. CAPLAN: Opposed?

[No response.]

DR. CAPLAN: Okay. That's unanimous.

DR. NIGHTINGALE: Unanimous for the second. Number two is passed unanimously.

DR. CAPLAN: And we're stumbling toward three.

DR. HOOTS: Question: Are we going to put "registered and unregistered" in one or in three or in both?

DR. CAPLAN: I think we'll put it up in one just to use it as the definition throughout.

DR. NIGHTINGALE: Is there discussion?

DR. GUERRA: Deviations is either on the plus side or negative side or do we need to make--

DR. NIGHTINGALE: Is there a plus for a deviation from approved procedure?

DR. AuBUCHON: Not from a blood banker's perspective. All deviations are bad. My only comment on this, I don't have any problem with deviations, but deviations from approved procedures can, at least in our shop, include those changes from procedures that I may approve as a physician for an individual patient for a specific medical reason, and those aren't really intended to be included in what I think we're talking about here. We're talking about deviations that are unplanned, accidental or as a result of errors.

DR. NIGHTINGALE: Then "unplanned" would be a good word to put before "deviations" or would it be?

DR. CAPLAN: Mary?

DR. CHAMBERLAND: Well, building on the language that we have now established in the previous recommendations, aren't we talking about errors and accidents that are both subject and nonsubject to regulatory requirements? Does that capture the universe of--because I'm sort of, I have some concerns that some of this language, you know, we worked on before we had now this firm foundation in one and two, and, again, trying to be consistent throughout all of these.

DR. NIGHTINGALE: Where are you going with the sentence?

DR. CHAMBERLAND: Well, it should capture data on all errors and accidents, both subject and not subject to regulatory requirements. We got in this place because of the concerns expressed about using "errors and accidents," which means something very specific in regulatory language. So we fixed it in recommendation number one by specifying that we were interested in systems that went beyond errors and accidents captured by regulatory requirements.

DR. CAPLAN: I understand what that concern is. Let me make a suggestion there. We'll try--I want to keep this recommendation clean. After the meeting, I'm going to ask Steve maybe to talk to me, an appropriate person, so that we can footnote it or amend it just as we were going to cross-reference some of the regs earlier so that we clarify that we're not trying to undercut existing regulatory things. But to spell it out in there is going to kill that regulation in terms of anybody being able to read it. So I would suggest we keep it clean and maybe keep it up in the preface somewhere, what we had in one.

DR. NIGHTINGALE: I like keeping it clean. I can tell you a lot of people are going to read these things, and the force of them is based on their having been written and approved in an open, democratic process within the explicit guidelines of the Federal Open Meeting Act. I am very reluctant to doing anything that either slows down the process or does it in anything that's not under the public glare.

DR. CAPLAN: Jay?

DR. EPSTEIN: I think the way to make this clean is to put a period after the word "procedures" because, you know, if it's all procedures, then all of the other caveats become moot.

DR. NIGHTINGALE: But then you get rid of, regardless of what--

DR. EPSTEIN: Well, if it's all procedures, it's certainly regardless of caveats. Also, I would again propose that we change the word "approve" to "established."

So it would read, "Quality assurance programs in all blood establishments would capture, analyze and respond to data on all deviations from established procedures."

DR. AuBUCHON: I'd second that.

DR. CAPLAN: Ron?

DR. GILCHER: I want to come back to what Jim AuBuchon said, and that is I think there needs to be said or implied in a footnote, where we have data on all deviations from established procedures, "excluding approved medical exceptions," so that you don't interfere with the practice of medicine in those special situations.

DR. PILIAVIN: Ron, doesn't "established" do that for you? I should have thought that's what Jay meant because it's an established procedure, that there can be medical exceptions to approved procedures.

DR. GILCHER: And we could footnote that.

DR. NIGHTINGALE: I don't--you can't footnote a recommendation. It's either in the recommendation or it isn't.

DR. GUERRA: I guess I would use the special case of exchange transfusions that, in some instances, are certainly within the realm of established and approved recognized procedures, but that today there is technology available that precludes that. And it would not come out as a deviation. But I think that it would be important to be able to capture those outliers, if you will.

DR. CAPLAN: Let me just say, if you put a period after "procedures," if you're worried about "physician discretion" there, I think that the quality assurance program should expect an explanation. The explanation is it's physician discretion. So that's what's going to happen here. I don't think it's taking away the authority. I think it's saying if something's deviant, explain it.

So Jim would say, "I made this decision about this individual patient, and that's why this deviation happened." So that it doesn't diminish the authority, it just says Q&A should ask, which it should. So I wouldn't do anything here. I would leave it exactly the way it says and expect people who deviate to account. But it's a pretty simple--

DR. GILCHER: But I think it already does in all of our systems. I mean, we have a medical exception form, and every time we do an exception, I fill that form out.

DR. CAPLAN: Right. But I think that's the spirit of the recommendation that everybody be doing that.

DR. NIGHTINGALE: That's the spirit. But if you take the words "errors and accidents" out of this, you are going to remove your debate from what the rest of the town or the rest of the country is talking about right now.

DR. CAPLAN: No, but wait. Put a period there, and then what I would suggest is maybe we could add something like "This should be done with all errors and accidents with the same--" In other words, that sentence two in there, if you want to do that.

DR. NIGHTINGALE: Again, if you stop talking about "errors and accidents," people are going to stop reading because that's what everybody else is talking about. And if you make an explicit decision to take those words out, you've taken away--

DR. CAPLAN: I don't want to take them out. I was just going to make it a period and then put it into sentence two, but I don't care.

DR. NIGHTINGALE: Honestly, the way that I would prefer to see this sentence done is to say, "Errors and accidents, as well as all deviations from established procedures." You've got to have some concern for the way other people outside this room are using the English language right now.

DR. HOOTS: I actually think that's a reasonable thing, to invert the sequence and continue as it's written.

DR. DAVEY: I would support it, too, but I would eliminate that last big phrase. I think we don't need that.

DR. WINKELSTEIN: I'm not in transfusion medicine so perhaps this perspective is going to be helpful. Without the last phrase, as Steve suggested, it has less meaning for me. And I think I'm more representative of the audience to which this would be aimed.

DR. PILIAVIN: Excuse me. Why are you reversing those? I think what you want to say is that we should respond to data on deviations from established procedures, as well as on errors and accidents, because they already respond to data on errors and accidents. So what you're trying to tell them is to do this, as well as what you're already doing. So you don't want to invert it. You want to put it back the way it was.

DR. NIGHTINGALE: No. The issue right now is really whether or not you extend your purview to errors and accidents, independent of whether blood units were distributed or caused adverse medical reactions. That's really the issue on the table right now is how broad is your scope. And what we heard yesterday was broaden it and don't drop the egg.

DR. CAPLAN: Jay?

DR. EPSTEIN: I would echo Mary Chamberland's earlier remark to fix it in three the way we fixed it in one. It would say, "All deviations from established procedures, including errors and accidents not subject to regulatory requirements." That gets back the term "errors and accidents," and it again avoids the confusion with the existing systems. So, again, it would say, "All deviations from established procedures, including errors and accidents not subject to regulatory requirement."

DR. NIGHTINGALE: I would leave it the way it is. And the reason that I would say I leave it the way it is is not because I think Dr. Epstein's suggestion changes the meaning of it, but I think it changes the ability of others to understand that we're talking about the same thing that they are.

DR. PILIAVIN: I think Jay's is much clearer.

DR. CAPLAN: Larry?

DR. ALLEN: Where do the controls of mandatory versus voluntary come into play with these recommendations?

DR. NIGHTINGALE: Down the road.

DR. CAPLAN: They haven't shown up yet.

Other comments on language here?

DR. SECUNDY: I'm not clear what "same effort" and "vigilance" refers to. Same effort as what? That may have been discussed before I came in, but it's not clear.

DR. NIGHTINGALE: The language initially said, "Same effort for those that did not cause harm as those who did." The syntax is left over from an earlier version.

DR. SECUNDY: Okay. Well, it's not clear, I mean, as it is now.

DR. PILIAVIN: We are taking that out, aren't we?

DR. CAPLAN: So would you just say, "From established procedures, as well as errors and accidents," at least as it's written up there, "whether affected units were distributed or not"? Is that what you're--get rid of "the same effort"?

DR. NIGHTINGALE: You can get rid of "with the same effort." Yes, you can get rid of "with the same effort and vigilance" without changing the meaning, and you can get rid of a few words.

DR. AuBUCHON: Art?

DR. CAPLAN: Yes, Jim?

DR. AuBUCHON: I have some philosophical, as well as procedural, problem with the implication in this that every deviation from every procedure needs to be tracked down to the same degree. If we are, unfortunately, about to cause the death of a patient because of an error, I'm going to spend a lot more time and effort tracking that down than if it's simply an incorrect keystroke on a computer entry that really has no bearing, has no potential of causing anyone any harm. So I think some graded response to the error, accident or deviation is appropriate.

DR. PILIAVIN: They took out the "equal vigilance" stuff.

DR. AuBUCHON: Well, it even pertains to "distributed or caused adverse reaction."

DR. NIGHTINGALE: But we also added, as Dr. AuBuchon said, in the words, "deviation from established procedures," a broadening of the scope of this beyond--of our deliberations beyond errors and accidents. And Dr. AuBuchon raises a very important question; is that where we want to go?

DR. SECUNDY: Is that not inherent in any good quality assurance program?

DR. NIGHTINGALE: That's what the question is all about; do we want to go there, too, right now, as opposed to do we want to define "physician judgment," for example, as a potential error and accident? Some would say no.

DR. CAPLAN: Ron?

DR. GILCHER: I would like to change the last word "reactions," to "event" or "caused adverse medical event" or "events."

DR. CAPLAN: My comment is I would keep, I wouldn't do any wordsmithing toward graded responses in this recommendation because I think quality assurance is supposed to come up with ways to respond to minor and major deviations. So I don't think I would spell it out. I would just leave it. I know what Jim is saying. I just think it's one of those things where the Q&A has to do it, not us.

DR. NIGHTINGALE: Also, I think because these are recommendations that are going for further processing, that we may be approaching the point of diminishing returns here.

DR. CAPLAN: How about anybody interested in a motion on the language that's up there now?

DR. SECUNDY: So moved.

DR. GUERRA: Second.

DR. NIGHTINGALE: Dr. Secundy, and Dr. Guerra seconds.

DR. CAPLAN: Discussion?

[No response.]

DR. CAPLAN: All in favor?

[Show of hands.]

DR. CAPLAN: Opposed?

DR. NIGHTINGALE: Dr. Piliavin opposes.

DR. PILIAVIN: Piliavin.

DR. NIGHTINGALE: I apologize. It is Piliavin. It's been three years, and I'm going to learn it soon.

DR. AuBUCHON: I would like to abstain.

DR. CAPLAN: Do you want to hear the objection?

DR. NIGHTINGALE: Jane?

DR. CAPLAN: Jane, do you want to say something about the objection?

DR. PILIAVIN: Yeah. I just liked Dr. Epstein's wording a whole lot better, and I don't like this wording, and so I'm voting against it because I think the other wording was much clearer.

DR. NIGHTINGALE: Thank you.

MR. WALSH: Just a point of clarification, Dr. Piliavin made the motion, didn't she? I believe that Jane made the motion.

DR. SECUNDY: I did.

MR. WALSH: Oh, you made the motion. Okay.

DR. CAPLAN: All right. Let's take a peak at four, which is the--aren't we up to the AABB?

DR. NIGHTINGALE: This is recommendation number one that was suggested by America's Blood Centers.

DR. CAPLAN: Do we need it any more?

DR. AuBUCHON: I fully support the concept, but I have great difficulties with the particulars of this recommendation. I support the concept of a broadening of reporting requirements, and I do mean requirements--it is mandatory reporting for errors and accidents in a non-FDA sense--to apply to all establishments and for these reports to be accumulated in some national way, with periodic analysis and dissemination of useful information.

I'm concerned that the FDA be the focus of this, with all due respect to my esteemed colleagues, and I do regard them as colleagues in the FDA. I just don't think that the Agency is set up to handle the barrage of transfusion service reports that they're about to receive if they do this.

DR. NIGHTINGALE: Dr. AuBuchon, could I suggest that we could substitute the word "The Department of Health and Human Services," since that includes HCFA?

DR. AuBUCHON: I'm not even sure that I would want necessarily the government to be the individuals who are collecting and analyzing these data.

DR. NIGHTINGALE: Dr. Chamberland?

DR. CHAMBERLAND: Clarification. I don't read this recommendation to apply to what we just previously recommended. This recommendation I think speaks to a very specific issue about, which I think FDA is currently engaged in rulemaking on, and maybe Jay can expand it, I don't think number four applies to the expansion of near misses and all of that. It's another issue.

DR. NIGHTINGALE: Dr. Epstein?

DR. EPSTEIN: If the intent in number four is to advise FDA to extend the reporting requirements to registered establishments and transfusion services, that is indeed the content of the proposed rule, which will be soon published as a final, making item four, in effect, moot.

The question is whether the report requirement should be extended from what it is now limited to, which is errors and accidents in the blood bank which affect released units, independent of whether there's an adverse medical outcome in the patient. So, in other words, if there's a wrong unit administered at the bedside, FDA's proposed rule, soon to become final, would not require that reporting unless it was a fatality.

So I'm just not clear what the intent of four is. If you are concurring with the proposed rulemaking, I would suggest it's unnecessary. If you are asking FDA to extend the scope of reporting to which transfusion services and hospitals are subject, then I think that's a very big issue, which we haven't really teased out. For example, one of the proposals that we heard today was to let that be part of the voluntary reporting system to the NBDRC. So it's not automatic that it should be extended by FDA. It hasn't been debated whether it should be extended by HCFA, and it's not the only model possible anyway.

So I'm just again concerned. I think there's some imprecision here, where we're really trying to go. As stated, the matter is moot. That's what the proposed rule will do when it's finalized.

DR. NIGHTINGALE: Jay, this is Steve Nightingale. I think that the intent of the rule and the intent of most people--the understanding of most of the folks of the committee is that this is in support of that proposed rule. I would respectfully disagree that just because it has some steam behind it doesn't mean it's going to happen tomorrow. Dr. Epstein is well familiar with what the Office of Management and Budget can do with proposed or even final rules.

DR. EPSTEIN: Okay, then, on that model, I would suggest that the word "registered" in the last line be changed to "licensed," since the current requirement is licensed, and just add the word "should." "FDA should extend..." and then that would be a recommendation in favor of finalizing the rule as proposed.

DR. NIGHTINGALE: And that would not be moot by any means.

DR. CAPLAN: Other comments?

Jane?

DR. PILIAVIN: You need a "than" between "rather" and "only."

DR. CAPLAN: Motion?

DR. DAVEY: So moved.

DR. KUHN: Second.

DR. NIGHTINGALE: Dr. Davey, and Dr. Kuhn second.

DR. CAPLAN: Discussion? Jim?

DR. AuBUCHON: I guess at this point I should state why I'm probably going to vote against this, despite the fact that I do agree that a national reporting system is appropriate, because it would appear that to vote for this is going to be an endorsement for the final rule.

I had many objections to the proposed rule, and I don't know, obviously, all of the details of the final rule. It hasn't been released yet. And I am reticent to support this proposal for fear of it being interpreted as supporting the final rule, when I just don't know what that is.

DR. NIGHTINGALE: I think that that is a very legitimate concern, but is there any wording in--are there any of the current words in number four to which you object to, individually or in aggregate? That's the first question.

DR. AuBUCHON: I wouldn't change a word or two, I would restate the concept, as I've stated before. There should be a national reporting system for all of the events, we'll call them errors and accidents, but all of the events relating to blood transfusion safety.

DR. NIGHTINGALE: Is that not a separate issue from this one?

DR. AuBUCHON: Not in my mind. I would like to see a single reporting system, not fragmented reporting systems where you report some things to the FDA on their forms, and some things to JCAHO and their system, and some things--it can get very complicated. We've got to have a single system.

DR. NIGHTINGALE: But it strikes me that that's a very rich, complex and, I think, different from this one. This one, I think, speaks for itself. I understand what you're saying. I think that your concern should be addressed in a separate recommendation of the committee or at least a proposed recommendation that would provide context to this one.

DR. CAPLAN: Jay?

DR. EPSTEIN: Could I again suggest that we clarify, blood establishments, in FDA parlance, do include hospital transfusion services. So just change the word "and" to "including." In other words, it's being stated redundantly for clarity, but it suggests that it's not subsumed when, in fact, it is subsumed. So "including."

And I would also add the preposition "rather than only two licensed blood establishments."

DR. CAPLAN: Other comments?

This motion is seconded, and hanging out there. So it's going to be calling a vote here. All in favor?

[Show of hands.]

DR. CAPLAN: Opposed?

[Show of hands.]

DR. NIGHTINGALE: Dr. AuBuchon opposes. All other members approve it.

DR. CAPLAN: Keith?

DR. HOOTS: I'd like to propose that for the next recommendation we address Jim's issue, which has to do with trying to achieve some parsimony of reporting and something that can work in a centralized and very efficient manner rather than in a diffuse, disparate manner.

DR. NIGHTINGALE: Dr. AuBuchon, do you wish to make a recommendation?

DR. AuBUCHON: I believe I gave you some language to that effect earlier.

DR. CAPLAN: What is on five down there now?

DR. AuBUCHON: I'm trying to figure out how to change my wording into something that sounds like a recommendation. Propose the following: "That there be established a system--" I'm sorry.

DR. CAPLAN: Is she typing what you have, Jim?

DR. AuBUCHON: No.

DR. CAPLAN: Something else.

Don't pay attention to that man behind the screen.

DR. AuBUCHON: I'm just not sure I'm going to be able to do this twice. That's the problem. "There should be established a system for the accumulation, analysis and dissemination of data derived from all blood establishments' quality assurance programs that would facilitate improved transfusion safety through a mandatory, confidential, nonpunitive system managed outside of the regulatory framework."

DR. NIGHTINGALE: Would you like to leave "mandatory" for another motion?

DR. AuBUCHON: No. I think "mandatory" is an important part here because the point was made yesterday that if something is voluntary; that is, if a hospital may or may not do it, that in today's current economic environment, most hospitals will not do it. It needs to be mandatory if it is going to be complete, mandatory as in required.

DR. NIGHTINGALE: Would you read it once again at typing speed.

DR. AuBUCHON: "There should be established--"

DR. CAPLAN: He's got a "There should be established."

DR. AuBUCHON: "There should be established a system for the accumulation, analysis and dissemination of data derived from all blood establishments' quality assurance systems that would facilitate--"

DR. PILIAVIN: You need an apostrophe after "establishments."

DR. AuBUCHON: "--that would facilitate improved--"

DR. CAPLAN: Keep going. We'll put the--don't even worry about the spelling right now. Let's just get it up there, and then we'll go back and fix it.

DR. AuBUCHON: "--that would facilitate improved transfusion safety through a mandatory, confidential, nonpunitive system managed outside the regulatory framework."

DR. SECUNDY: Congressional action or are you thinking within the framework of governmental agencies or private industry? I mean, who should establish? I think it's awfully vague.

DR. AuBUCHON: I hadn't take it any further than that.

DR. NIGHTINGALE: Jay or Mary, do you have some comments?

DR. EPSTEIN: Well, I guess that there's an apparent conflict with the existing regulatory system here. Are you saying that we should therefore not continue the current regulatory reporting system, which is, after all, a system which accumulates, analyzes and disseminates information obtained from all of the blood establishments' quality assurance systems?

Again, we need to distinguish what is semantic from what is the real intent of the proposal. If the intent of the proposal is that there should be national aggregation, analysis and dissemination of the data gathered under item one, then we don't have a conflict. If, on the other hand, you are saying that that system which accumulates, analyzes and disseminates the data should be confidential, nonpunitive and outside regulation, you are saying FDA should stop what it's doing.

So I'm not clear, again, what the real intent here is, and we need to discuss the intent before we discuss the wording.

DR. AuBUCHON: I have no objection to the FDA continuing what it is currently collecting, and I have no problem with the FDA having access to data that might be submitted through the system envisioned in item number five here, as it pertains to particularly the issues that the FDA has always been concerned about, particularly product safety. I am concerned about extension of that current FDA system into the transfusion service only for fear, or primarily out of fear that the data collected at some considerable effort will not be analyzed and disseminated in a manner that's useful to those who are submitting it. Instead, I am proposing a system that goes beyond the transfusion service, further than the FDA is currently planning on looking, as I understand it, all of the way to the bedside, as would be included in a transfusion service's quality assurance system, and collecting it in a manner could be within the FDA, but outside of the usual regulatory framework so that the data are analyzed and are useful to those who are trying to improve the safety of the transfusion system.

DR. NIGHTINGALE: Jim, Steve Nightingale.

I believe that the genesis of your suggestion is the example of the aviation system, where the near missing goes to NASA Ames and is compiled by Battel. It is worthwhile to remember, particularly in light of Dr. Epstein's concern about this, that the FAA can, in the interest of public safety, acquire whatever information it needs to preserve that public safety. In fact, much of that system, as I understand it, involves a delegation of statutory authority rather than an abrogation of it. And that may or may not address all of Dr. Epstein's concerns, but I'm sure it addresses one of them.

DR. AuBUCHON: Well, if the FAA would like to start gathering this data, that's fine.

DR. NIGHTINGALE: You obviously don't work in the airline industry.

DR. McCURDY: Following up on that, I think that wherever the information is going to be collected and analyzed will probably require additional resources to do this. And as you pointed out, if the additional resources are provided, one place or another, they perfectly may do this on contract, such as is done by NASA.

DR. NIGHTINGALE: I think we've got the right idea and the wrong words. Jay, is that close to your thinking?

DR. EPSTEIN: Well, I guess if it opened by saying, "In addition to mandatory regulatory requirements, there would be established--" Because then it's clear that you are not seeking to supersede the regulatory requirements.

DR. NIGHTINGALE: Dr. Penner?

DR. PENNER: He's really saying that without this it would be discretionary for FDA then to pick up a contractual arrangement if they wanted to and carry it out. So I question, Jim, whether you need this. If it looks like they're being overwhelmed, there's no doubt that FDA would probably look to contracting an outside agency to follow the additional material.

DR. NIGHTINGALE: Dr. Piliavin?

DR. PILIAVIN: I really don't want the FDA to be doing this because I think we want to have a separate system that is nongovernmental that people will feel is like the research organization that already exists, that it's there for analysis, it's not there for regulatory purposes.

DR. NIGHTINGALE: The issue revolves around the definition of "this," and "this," under current parlance, is information that is not covered by current statute. That's a lot of information. And what's left over, after the current statute's limits are exhausted, is, frankly, not everything you want in a voluntary system.

If you want your voluntary--what you really want is as much reporting of the near misses as you can, in the hopes of getting enough of those near misses before you get a direct hit, will avoid the direct hit, you need to identify the gray area which might be under joint FDA--mandatory and voluntary review. To do that, you're probably going to need more sentences than we've got up here.

My suggestion at the moment is to try to get a sense of the committee as to whether they think the current language is workable within the next 15 minutes, and particularly, can we get the ideas that I think we share into the language that's up there?

DR. DAVEY: Steve, I would suggest that we put in dissemination of data from quality assurance systems. And right now it says we disseminate the quality assurance systems.

DR. NIGHTINGALE: Good point.

DR. HOOTS: I know we want succinct but if we did what you--and if we stated what you just implied, you know, something like a "or whereas the FDA does this we would recommend that in addition a dot, dot, dot, a system that can accommodate dot, dot, dot, be established." Would that be concise enough for a recommendation?

DR. NIGHTINGALE: Well, actually that might. Dr. Epstein, is the language up there compatible with your statutory mandate? Dr. Epstein is shaking his head.

DR. EPSTEIN: No. I don't believe so. Because, look, again, information reported to the FDA is subject to Freedom of Information Act. So, it's not confidential. Secondly, it could be argued that because our intentions are regulatory we may think of ourselves as, you know, benign friends of the industry but there are those who would say we are the punitive system.

So, almost by definition, you're now calling for the data which is now in the FDA system to instead go to the confidential non-punitive system managed outside the regulatory framework.

So, unless you're distinguishing which data one of two things happen. Either you're saying the system should coexist but then the reporting should be to two entities, both FDA and this other entity. Or you're saying that the FDA system now should be superseded. And I'm not happy with either outcome.

I would rather--and it's just my point of view--I would rather that this element be focused on the set of data that was identified in recommendation one, namely, errors and accidents not already subject to regulatory requirements, or not subject to regulatory requirements. So, that's what I would rather see this say, because then in essence, you're saying create the NTSB-like system where the near-misses go to one place and the actual events go to another place.

DR. NIGHTINGALE: And that concept you're not--

DR. EPSTEIN: No, I wouldn't have a problem with that concept. Because then you're creating a complementary system and you're also neither undercutting nor inundating FDA because you're not calling for FDA to handle this 10-fold increased data stream but you're also not telling FDA to stop what it's doing.

DR. PILIAVIN: My interest in this would be purely wearing my academic research hat that someone is going to want to be able to compare the near-misses to the benign events to the real accidents and injuries and see how various factors relate to the ones that don't go bad as compared to the ones that do. That's why I think we should have it in one system.

If we could have a system that is set up to intake the near-misses and then the FDA would send over their reports, it would solve it. And then people wouldn't have to report some things twice and one thing once and get all confused. But it would be awfully nice if all of the data could somehow end up in the same place. That's what would be in my mind what you would want for an analytic system.

DR. NIGHTINGALE: And perhaps that's one step farther than we need to be today. I think that I can certainly identify a system including the current FAA/NASA AMES system where the data on near-misses and the data on direct hits are, in fact, compared and have been done so for five years anyway.

So, I share your concern. I do think we have a precedent that says that that concern could be addressed in detail.

DR. PILIAVIN: Okay. Then I, for one, would be perfectly happy to change it along the lines that Jay is suggesting so that this becomes a separate system that inputs only the data that doesn't go to the FDA.

DR. NIGHTINGALE: Dr. AuBuchon.

DR. AuBUCHON: Might we possibly accomplish that by inserting in the first line of number five, before the word, system, either the word complementary or coordinated?

DR. NIGHTINGALE: Complementary?

DR. AuBUCHON: With an "E". With the idea that that's referring complementary to number four.

DR. CHAMBERLAND: But as you defined quality assurance systems for an earlier recommendation it included information that was collected as required by FDA and outside of that. So, I think what complementary doesn't solve the problem. I think as Jay suggested you have to specify that piece of the data in this QA system that falls outside what FDA currently collects or regulates.

DR. AuBUCHON: I'm trying to accomplish though what Dr. Piliavin has suggested that these events are reported only once, not twice for some of them.

DR. NIGHTINGALE: That is correct and the reason we're having trouble is that we have not yet resolved that as a society or as a political process: which goes where? So, I suggest that our problems are legitimate and we may be trying to force an idea out that is about two or three months ahead of it. I hope not because I think the idea is important but that is what I see our problem is.

Jay?

DR. EPSTEIN: Well, the language I would propose is on line 1 to say, for errors and accidents not subject to regulatory requirements.

DR. NIGHTINGALE: Yes.

DR. EPSTEIN: And just delete complementary. There should be established a system. That is the thing that makes it come out complementary and eliminates dual reporting.

And I think it's worth mentioning that since anything reported to FDA is not confidential certainly it can also be provided as information to the confidential system. Nothing would preclude that. I don't see why government would resist that and even if we did you could request it under FOIA.

DR. NIGHTINGALE: Jim, are we getting closer to what you are hoping to accomplish?

DR. AuBUCHON: Now, we get into the issue of what is an error and an accident? Because the Food and Drug Administration's purview is that those don't occur except within the laboratory and I'm trying to extend this to the entire transfusion system from vein-to-vein.

DR. NIGHTINGALE: I have error and accident in the current language, however.

DR. EPSTEIN: Why is that a problem? In other words, it is an error and accident not subject to regulatory requirement. One way in which it's not subject is if it's outside our definition. So, it would just be captured in this complementary system. Because we're not saying you, therefore, can't capture it. Just if we capture it, it goes to our system.

DR. NIGHTINGALE: And, furthermore, one of the many benefits of the language that Dr. Epstein proposes is that it admits to evolution of the system over time and there sure is going to be a lot of that.

DR. CAPLAN: Paul?

DR. McCURDY: Implementation of this will require some descriptive language as to what is an error and what is an accident, and I don't think we can do this satisfactorily enough here. I think the people who implement this, assuming it does get implemented, will have to provide the guidance necessary for people to do the reporting.

DR. PILIAVIN: I move this language.

DR. NIGHTINGALE: Yes. Dr. Davey was recognized.

DR. PILIAVIN: Sorry.

DR. NIGHTINGALE: No. Just the reason that if this is tricky and the more views we get on the table the better we will serve the public interest.

DR. DAVEY: Yes. I'm wondering whether at this point we should include the word, mandatory. There was a lot of discussion of voluntary versus mandatory, the voluntary with incentive, and how best to structure this program which I think probably we can support. I think that requires a bit more study and I'm not sure that putting mandatory in at this point is useful. I would prefer it be removed as it has been.

DR. CAPLAN: Ron?

DR. GILCHER: I would like to change the modifiers in a sense. There should be established a system and then say that facilitates improved transfusion safety because that's what we're really trying to do through a confidential non-punitive system managed outside the regulatory framework for the accumulation analysis and dissemination of data.

Because we really want an improved system that facilitates improved transfusion safety.

DR. NIGHTINGALE: It's unclear to me what concepts were included in the additional words that are not in the current.

DR. GILCHER: Well, I just simply made a switch. I didn't add anything. I reversed the order, that's all. I said establish a system that facilitates improved transfusion safety.

DR. NIGHTINGALE: Thank you. I'm corrected.

DR. CAPLAN: Fernando?

DR. GUERRA: I suspect that in this instance it would be better to err on the side of over-reporting.

DR. PILIAVIN: You can just cut and paste from below.

DR. GUERRA: And that will happen. In the vaccine adverse event, it's just you have probably about ten to 15 times more reports than what actually are confirmed to have been a significant adverse event.

DR. KUHN: Going back to Rick's comment, I would like to keep in the word, mandatory, because I think that you have some qualifiers there such as non-punitive, and what was the other one--confidential. And I think it would give more incentive for people to at least give that information that is really needed. But I think those qualifiers would probably alleviate any concern that someone would have regarding mandatory.

DR. NIGHTINGALE: But the problem with the word, mandatory, right now as I understand it is the complexity of the ideas behind the term. If we mandate a voluntary system, for example, is it mandatory or voluntary? That's--you are arguing a substantive point, I'm arguing a technical point. Dr. Davey is shaking his head. Do other people see it the same way I did?

LT. COL. SARACINI: I think that point about whether it should be mandatory or voluntary should be a separate point. I think we all agree that we should have the system and discuss the point about mandatory or voluntary as a separate issue.

DR. GUERRA: Change the word, for, after framework to, by, outside the regulatory framework, by the accumulation analysis and dissemination of data.

DR. NIGHTINGALE: Is there agreement on the language that is up on the word processor right now?

MR. WALSH: I'd be more comfortable if there was more clarity as it relates to mandatory if we're going to address mandatory versus voluntary.

DR. NIGHTINGALE: But let's make sure we got the language right before we go to mandatory.

MR. WALSH: I understand that but if we go there and it's important to put it here as opposed to some place else if it doesn't get there.

DR. NIGHTINGALE: We're going there in a minute.

DR. PILIAVIN: I think the language now is very confusing because what we want is that it's a system for the accumulation, analysis and dissemination of data. You don't want the: through a confidential, non-punitive system, up there. It's all--the wording is all screwed up now. It's a syste--

DR. GUERRA: One facilitates improved transfusions.

DR. PILIAVIN: That facilitates improved transfusion safety but it's also a system that for the accumulation, analysis and dissemination of data, which is how we started. Now, that's way at the tail-end and it doesn't make any sense down there.

DR. GUERRA: We want to facilitate transfusion safety by utilizing the information that is the accumulation of the analysis and so forth.

DR. PILIAVIN: But the system is a system for the accumulation and analysis. That's what the organization--we're talking about an organization. It made much more sense before. I understood what you wanted to put in but I don't think--I think it's completely screwed up the meaning of it now.

DR. NIGHTINGALE: Dr. Hoots?

DR. HOOTS: I think what Jane is talking about makes some sense. I mean in terms of usually you would follow the adjectival phrase closer to the noun. Because otherwise it kind of gets dangling out there. And I know what Ryan is talking about but I think that the emphasis here is kind of we want transfusion safety. That kind of goes without saying, but what we really--the real meat of the matter is the system that collects and analyzes.

DR. PILIAVIN: What we want to say is in order to facilitate improved transfusion safety--could you back it up to the top of the sentence, please? Way up at the top. Just go back to the top of item four. In order to facilitate improved transfusion safety, no capital for, for errors and accidents not subject to regulatory requirements there should be established a system for the accumulation, analysis and dissemination of data, blah, blah, blah, through a confidential non-punitive organization managed outside the regulatory framework.

DR. HOOTS: Yeah. A system for the accumulation.

DR. PILIAVIN: Cool. That's great. And then a comma after the systems, at the beginning of that sentence. No, that's fine. That's fine, right there. And take off the bottom by. That, I think, makes the sense that we want. Although using systems several times is problematic.

DR. CAPLAN: Jay?

DR. EPSTEIN: I agree with Jane on what's wrong but I think it's not entirely cured. I think what is needed here is to move all the modifiers of the system in front of the word, system. So, that it would say a confidential, non-punitive system managed outside the regulatory framework, that, or through accumulation, analysis, dissemination. Just move all of that--

DR. NIGHTINGALE: I agree.

DR. EPSTEIN: Just move all the modifiers of, system, before the word, system.

In other words, there should be established, right, a confidential--

DR. PILIAVIN: [Editorializing.]

DR. EPSTEIN: That would be fine also.

DR. CAPLAN: Jim?

DR. AuBUCHON: I don't have any comments on the phraseology here and I don't want to get involved with that, but I do have a comment about mandatory. If we are having difficulty with the term, mandatory, could I suggest we consider putting in the word, required. It's a little bit clearer and avoid some of the phraseology we heard that is used differently by different people yesterday.

I am afraid that unless the term required is inserted that the system will gather data that are very incomplete. We saw this morning a brief exposition of some of the data from the bacterial contamination study and, frankly, it has a lot of holes because it's a "voluntary system". Unless it's required transfusion services will not be able to muster the resources inside the facility to participate in this. And without their participation it's meaningless.

DR. PENNER: I would agree with Jim. I think that you have to have it mandatory requirement or you get nothing back. No one wants to add and send off additional information unless they have to.

DR. CAPLAN: Mary?

DR. CHAMBERLAND: I guess I would say that my thought on this is that we're really still so very early in this whole process of trying to implement systems to address the error of patient safety of which transfusion-related errors are only one piece. And usually and what you're talking about is the whole paradigm shift which I think is good and the committee has broad agreement to move in that direction.

But usually when you try and implement something this comprehensive, this complex, oftentimes you try and do it in--not in one fell swoop but some sort of graduated program, pilots, demonstration projects, et cetera, because I would submit that maybe we really don't know what is going to work best and resources are a key issue.

In the data that was presented on the MERS-TM system was very impressive. The number of reports in this kind of a voluntary setting. Now, I would also say the caveat is that it's a very special setting, it's kind of a research project funded by NHLBI, et cetera.

So, I would just hate to see us boxed in prematurely by language when we're really, we really probably don't know. I mean Mr. Francis told us it took American Airlines ten years to refine a system. So, I think we have to say something about the system but that we need to kind of sort of leave it open-ended and we're really kind of in an exploratory initial phase.

DR. NIGHTINGALE: I would simply respond, however, that it appears to me and several of the speakers at this meeting that we are weeks if not days from the introduction of legislation on this area. So, I don't think we are that early in the phase and I don't think it's moving at a ten-year pace.

DR. CAPLAN: Larry.

MR. ALLEN: Just sort of a clarification. Is the idea to get all these recommendations then review them in terms of which ones should be mandatory and which ones should be voluntary; is that your plan?

DR. NIGHTINGALE: No.

DR. CAPLAN: This one, we're talking required mandatory or my favorite word, obligatory. An obligatory confidential but, whatever.

MR. ALLEN: Well, where does the voluntary/mandatory come into play at?

DR. NIGHTINGALE: Mandatory has, at least to me, a connotation of the Code of Federal Regulations required. Required, I guess, I had thought did not have the Code of Federal Regulations attached to it.

DR. PENNER: I think the small facilities is already mentioned, just will not respond. And I think you're going to have to wait ten years before you begin to get some of that accumulation.

DR. CHAMBERLAND: Jeff, if you really want to do this is that Dr. McCurdy made the point, there's going to have to be--and the IOM made this point--resources, new resources, not redirected resources put to this. You know, and the issue, in the arena of public health surveillance for diseases the number of cases, the completeness of reporting is clearly correlated with the amount of resources. HIV case reporting is the most complete, most comprehensive. But that's because there are millions, hundreds of millions of dollars that are put into that system.

By contrast, voluntary reporting will--by contrast to other diseases, there's not nearly that level of completeness. That's not to say the data aren't valuable because you don't need necessarily complete reporting to--for a surveillance system. But you really--I just as I said I'm just concerned that we're not quite there yet, and that we have to do some really piloting of the system, and even the IOM advocated a two-tiered approach, some things mandatory and some things voluntary.

DR. CAPLAN: Jim?

DR. AuBUCHON: I would just note that we're not voting on whether to make obligatory a system that is already defined and is in chapter and verse and 300 pages long in detailed procedures.

We're talking about a concept here. And undoubtedly this concept is going to take some time to evolve and we don't know what this is exactly going to look like. Initially, as it is rolled out, it would certainly be voluntary. It would be test-piloted, I'm sorry, tested as a pilot program in some facilities. And it's going to take some time before it would truly be mandatory. It won't be a week from tomorrow. But I think that concept of where we want to go in the end is that, in my opinion, it would be a required function.

DR. CAPLAN: Three people now have used the word, obligatory. So, why don't we try for changing required to obligatory. And the reason I like obligatory is that it has all the force of mandatory but it doesn't tell you who are obliged to. It could be a funder, it could be a Federal agency, it could be a licensing thing. So, there's probably room there, it sends a message that we want everybody in but we haven't said sort of what the enforcement game is and that's okay. I suspect that's going to take a while to hash out.

DR. DAVEY: I would prefer required but that's okay. I really think Mary was on the mark here. This is a very complex area and I think that--Jim, I have to disagree a little bit--I think this is fairly prescriptive, this particular paragraph as we have it. It doesn't allow to some extent the piloting, kind of experimentation, the sentinel work or whatever needs to be done to kind of figure out what is going to work and what kind of data we want to get and from whom and how obligatory are these data going to be needed?

So, I would--I am not happy with it as it is. I support Mary's comments.

DR. CAPLAN: Jane?

DR. PILIAVIN: Since both Mary and I want to get to the airport, I would like to propose an additional sentence here that might solve some of these problems, which would be something on the order of once such a system has been tested and funded, participation will be mandatory.

DR. NIGHTINGALE: You know, I think that you're--my impression is that you're trying to put too much weight to an advisory committee recommendation. You know, we're supposed to be at the cutting edge here. We shouldn't be quite as diffident as--

DR. PILIAVIN: No, no, you don't understand, Steve. I'm trying to send a message to the Government that it should be funded.

DR. NIGHTINGALE: The message has been sent back that we're supposed to talk about funding in April. That's a very strong message.

DR. KUHN: If I heard Steve correctly, if this is going to be going before some legislators I think there has to be some language in it which is going to have kind of a bite to it. Otherwise, it is not going to float before some legislators. And I think this language has, captures it at this point. Because definitely some legislators are going to come and they're going to ask very definitive questions of those who bring it before them and they're going to want to know what is required or what is mandatory and those are going to be pretty difficult questions to ask.

So, I think this kind of captures it and gives us the avenue to wiggle in.

DR. CAPLAN: Jay?

DR. EPSTEIN: What if instead of the word, obligatory, we said, an effective confidential, non-punitive system because that leaves open what it looks like in the end. In other words, what you would be saying is that you have to know it works. It may turn out that certain kinds of voluntary system are the best ones, and as long as you're shown them effective, everybody ends up satisfied.

So, I'm just suggesting that perhaps we don't need to decide today whether the best answer is requirement or obligatory, just that the requirement is that it be effective.

DR. CAPLAN: Strange as it may seem, I don't think effective and obligatory get the same work done.

DR. PILIAVIN: No.

DR. EPSTEIN: Well, I think it's different work but I'm trying to respond to Mary Chamberland's point, which I share.

DR. CAPLAN: But obligatory means potentially you have a voluntary thing that you are obliged to follow. What I'm looking for is the waffle here is the ought to do it, not the mandate, but the ought to. But there's a lot of places to be obliged to.

DR. PILIAVIN: But we all know that in order to be effective it's going to eventually have to be mandatory, that's why I like, effective. It doesn't come right out and say it, but we all know from the data we've been listening to that that's the truth.

DR. CHAMBERLAND: Other possible words are, you know, that we commonly use to describe surveillance systems are: sensitive or complete. You know, systems with surveillance that are sensitive, meaning that they are good at capturing the events you want to detect. Effective, I have no problem with.

MR. ALLEN: The only problem with effective is that there's no telling how long it's going to take before it becomes effective. I think, you know, we need to be concerned about the fact that at some point throwing out mandatory/voluntary is, you know, voluntary or mandatory, we need to deal with these things; we either do it now or let's come back to this later.

DR. CHAMBERLAND: I mean I submit it's really a research question, that this could potentially be addressed by piloting head-to-head comparisons within whatever, a hospital setting or whatever, mandatory, some sort of mandatory versus voluntary.

I mean in the end what you're looking for is complete and accurate information and the aviation industry and the MERS-TM folks have, I think put forward very convincing data that you can see significant increases in the number of reports. They may not be a 100 percent complete but they give you enough information to do the things you want to do which are fix the latent errors in all these other things that would go a long way in addressing safety.

DR. CAPLAN: Well, let's leave effective in there for now. Have I got a motion on that language?

DR. EPSTEIN: An editorial suggestion. I think it reads better if you take the words, outside the regulatory framework and put them after the word, established. There should be established outside the regulatory framework an effective, confidential dah, dah, dah. Just drop managed. There should be established outside the regulatory framework.

DR. CAPLAN: Motion?

DR. PILIAVIN: Are you calling the question because it's been moved.

DR. CAPLAN: Oh, it was moved. Okay.

DR. PILIAVIN: It was moved and seconded.

DR. CAPLAN: I didn't even know that. So, that was when I was indisposed.

All in favor?

[A show of hands.]

DR. NIGHTINGALE: The vote is who is in favor of the resolution as placed on the board?

[A show of hands.]

DR. NIGHTINGALE: Just voting members. Nine. Let me repeat the count. Dr. Winkelstein, Dr. Walsh--these are in favor--Dr. Winkelstein, Dr. Walsh is in favor. Dr. Hoots is in favor. Dr. Penner is in favor. Dr. Piliavin is in favor.

We're going to do this again. Keep those hands up high. We're going to do it again.

I got Winkelstein, Walsh, Secundy, Piliavin, Penner. I have Hoots, Guerra, Gomperts, Gilcher, Davey and I have AuBuchon.

DR. CAPLAN: Opposed?

DR. NIGHTINGALE: I have Pahuja, Kuhn, and I have Allen.

DR. CAPLAN: The motion carries.

All right, what's up there next? I know the airport beckons many or the trains or the buses.

Is that our list?

DR. NIGHTINGALE: This will be the last one when it's typed.

DR. CAPLAN: Mack, what is the next dates; do you remember?

April. Okay. Well--

DR. PILIAVIN: I would like to have the dates before I go since it's going to interfere with my classes again.

CAPT. McMURTRY: I believe it's the last Thursday, Wednesday and Thursday in April.

DR. PILIAVIN: Steve told me it was Tuesday and Wednesday.

CAPT. McMURTRY: No.

DR. NIGHTINGALE: Before we go it's--these dates are in a contract which is in our office. That contract is not in front of me. We may well want to check it with the hotel so we're going to decline to answer that one because we don't have the paper right in front of us.

What is on the website is correct, but--

DR. CAPLAN: But it's the last week of April.

DR. NIGHTINGALE: That's right, yeah.

I'm not looking at the website right now. CAPT. McMURTRY: That's correct, the website is correct for the April dates.

DR. CAPLAN: Is that that one? Is this 6 or 5? I can't remember now. We're up to 6 maybe.

Okay, it's 6. This is the--we love automation--resolution. Industry and government should be encouraged to facilitate the evaluation and implementation of devices that promise to prevent misidentification of blood products and/or patients.

Discussion?

(No response.)

DR. CAPLAN: Motion?

DR. AuBUCHON: So moved.

MR. WALSH: Second.

DR. NIGHTINGALE: AuBuchon and Walsh moved and seconded.

DR. CAPLAN: All in favor?

[A show of hands.]

DR. CAPLAN: Opposed?

[None.]

DR. NIGHTINGALE: None are opposed. It passes unanimously.

DR. CAPLAN: Well, I believe this may conclude the deliberations on the recommendations. Other business? Steve?

DR. NIGHTINGALE: I recognize Dr. Snyder.

DR. SNYDER: Yes. I have one quick question. Are we going to say anything about legislation to prevent discovery? When you say, confidential, that's what you're referring to, I'm assuming. Do we want to say anything about that? Do we need to say anything about that?

Because one of the biggest impediments to reporting what you're talking about in some of these motions is the fact that they are discoverable.

DR. NIGHTINGALE: My own suggestion to the committee would be that since this is a complex legal issue that it would be better addressed by the committee after the committee had had the opportunity to hear testimony from experts in the case.

DR. HOOTS: May I make a comment? It's a direct follow-up of that but not the same issue which is at a future meeting not too far, you know, down the road, can we address issues--I think Mr. Dubin made some very cogent remarks today about the sacred cow of liability and I think really we can't forever avoid--we can't change the system unilaterally, clearly, but I think we shouldn't avoid addressing the impacts of that system on the decisions that we make. Because I think if we do not speak up the story is out and maybe in Congress that well, nobody really has a problem with the system.

DR. NIGHTINGALE: In response to that it is my current expectation and we have discussed this with the Surgeon General, although we do not have a formal clearance from him at this point to have the August meeting of the Advisory Committee concerned with the general issue of no-fault insurance for blood injury. We expect that discussion to include a discussion of safety cautious, the sort of things Corey brought up in his talk and this does open up Pandora's Box to a broader discussion of liability.

DR. CAPLAN: Paul?

DR. McCURDY: I just wanted to put on the record that the NIH, NHLBI has a small business innovative research set aside that could very easily help people who may be interested in number 6.

MR. ALLEN: I thought we were going to get back to this mandatory/voluntary. Now, we're out the door.

DR. NIGHTINGALE: We're not out the door yet.

DR. CAPLAN: Well, my hunch is that they didn't want to do mandatory/voluntary because they didn't think they had enough data to decide what to do. That's what I heard. So, I didn't think there was a lot of sentiment to wrestle with it but we can--

DR. NIGHTINGALE: Here's the issue. The issue of mandatory and voluntary right now is difficult for many people to resolve because the question is not whether there should be mandatory for some and voluntary for others, but what should be mandatory and voluntary? And this is a place where I and I think many other people in the committee do agree with the sentiment that Dr. Chamberland and with her, Dr. Epstein, articulated a few minutes ago that maybe in some of this we'll a little bit ahead of ourselves.

I don't think that there is disagreement that the mandatory reporting of major torts or perhaps torts entirely should continue to be mandatory. There is concern that some things that are currently mandatory might not be. And the specific one that causes the most grief is, what about the transfusion of a B unit into an O recipient that doesn't cause harm? Sharon O'Callaghan brought that up. Should that be mandatory if it does not cause harm?

There is a spectrum of opinion on that subject right now and the spectrum of opinion is hard to focus right now because the question is what would be the benefit to society if that bad but non-harmful transfusion reaction were mandatorily reported? You heard from Linden comments that she had to correct her 1992 data because of under-reporting of events that didn't cause harm. Does that under-reporting affect the validity or utility of her results?

That is why I think many people in this room are looking to get out of the room before tackling the issue not because they don't want to tackle it, but because the issue isn't "tackleable" quite yet.

DR. CAPLAN: Why don't we agree that on April 25, 26, which is the next meeting, that we will go back to this issue. I mean I think we've got recommendations here that we can put into play in the immediate political context of error. We're going to also know more about both--trust me, the next time we're here--obligatory/mandatory; we're going to know more about insurance and liability and we're going to know something more about standardization because every one of these things is going to be wrestled with in the next two months that Congress is about to move on some of this stuff.

So, my suspicion is we'll have to be guided in some ways by what happens there, but I have no problem coming back to it, I just want to make sure we're in the flow here.

DR. NIGHTINGALE: Wrestled in 2, but also wrestled in 6. August will be right before an election. Dr. Snyder?

DR. SNYDER: No. I was just going to say for Larry's benefit that we do know that "the bad things", the majority of them are already mandatory for Food and Drug Administration. So, that it's a question now on the stuff that would be good to know that have not caused harm. Should that be voluntary or mandatory? The other is a slam-dunk. It's, it's reported. Somebody correct me if I'm wrong.

DR. CAPLAN: Larry, you have the final word.

DR. WINKELSTEIN: But I'd like clarification and I'm not trying to be facetious. This isn't basketball. There can be a foul even if there is no harm.

DR. CAPLAN: Sure.

DR. WINKELSTEIN: And that's part of my thinking in terms of what the whole point of the last day and a half has been which is there is something to be learned from near misses. So, that's going to influence my thinking on mandatory versus voluntary.

DR. NIGHTINGALE: And I think everybody's thinking is going to evolve over the next six months.

All right. So--

DR. WINKELSTEIN: So, these will be part of next meeting's agenda?

DR. CAPLAN: I will make sure we are back to mandatory/voluntary at the next meeting.

DR. WINKELSTEIN: Thank you very much.

DR. CAPLAN: And the direction is there to the staff to get that on.

Thank you.

DR. NIGHTINGALE: Move to adjourn?

MR. WALSH: So moved.

DR. AuBUCHON: Second.

DR. NIGHTINGALE: Mr. Walsh moves and Dr. AuBuchon seconds.

It is unanimous, we are adjourn.

[Whereupon, at 3:20 p.m., the above-entitled meeting was adjourned.]