U.S. GOVERNMENT PRINTING OFFICE

59–993CC WASHINGTON : 1999

BLOOD SAFETY AND AVAILABILITY

HEARINGS

BEFORE THE

SUBCOMMITTEE ON

OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

SEPTEMBER 23, OCTOBER 6, and OCTOBER 19, 1999

Serial No. 106–79

Printed for the use of the Committee on Commerce

(

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COMMITTEE ON COMMERCE

TOM BLILEY, Virginia, Chairman

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

MICHAEL G. OXLEY, Ohio

MICHAEL BILIRAKIS, Florida

JOE BARTON, Texas

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

Vice Chairman

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

STEVE LARGENT, Oklahoma

RICHARD BURR, North Carolina

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

TOM A. COBURN, Oklahoma

RICK LAZIO, New York

BARBARA CUBIN, Wyoming

JAMES E. ROGAN, California

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

ROY BLUNT, Missouri

ED BRYANT, Tennessee

ROBERT L. EHRLICH, Jr., Maryland

JOHN D. DINGELL, Michigan

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RALPH M. HALL, Texas

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

RON KLINK, Pennsylvania

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

THOMAS C. SAWYER, Ohio

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

THOMAS M. BARRETT, Wisconsin

BILL LUTHER, Minnesota

LOIS CAPPS, California

JAMES E. DERDERIAN, Chief of Staff

JAMES D. BARNETTE, General Counsel

REID P.F. STUNTZ, Minority Staff Director and Chief Counsel

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

FRED UPTON, Michigan, Chairman

JOE BARTON, Texas

CHRISTOPHER COX, California

RICHARD BURR, North Carolina

Vice Chairman

BRIAN P. BILBRAY, California

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

ROY BLUNT, Missouri

ED BRYANT, Tennessee

TOM BLILEY, Virginia,

(Ex Officio)

RON KLINK, Pennsylvania

HENRY A. WAXMAN, California

BART STUPAK, Michigan

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

JOHN D. DINGELL, Michigan,

(Ex Officio)

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C O N T E N T S

Page

Hearings held:

September 23, 1999 .......................................................................................... 1

October 6, 1999 ................................................................................................. 57

October 19, 1999 ............................................................................................... 107

Testimony of:

AuBuchon, James P., Professor of Pathology and Medicine, DartmouthHitchcock Medical Center ............................................................................ 27

Bianco, Celso, President, America’s Blood Centers ....................................... 125

Fredrick, Jacquelyn, Chief Operating Officer, American Red Cross Biomedical Services, National Headquarters ................................................... 119

Heinrich, Janet, Associate Director, Health, Education and Human Service Division, General Accounting Office ...................................................... 10

Roslewicz, Thomas D., Deputy Inspector General for Audit Services, accompanied by Joseph Green, Assistant Inspector General for Audits,

Public Health Service Audit Division, Department of Health and

Human Services ............................................................................................ 17

Satcher, David, Assistant Secretary for Health and Surgeon General,

Department of Health and Human Services, accompanied by Kathryn

Zoon, Director, Center for Biologics Evaluation and Research, Steven

A. Masiello, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, and Jay S. Epstein, Director,

Office of Blood and Research Review, Center for Biologics Evaluation

and Research, U.S. Food and Drug Administration ................................... 62

Sperry, Craig and Jennifer, c/o America’s Blood Centers ............................. 112

Sullivan, Marian T., Executive Director, National Blood Data Resource

Center ............................................................................................................ 23

Wilkinson, Susan L., Deputy Director, Clinical and Technical Services,

Hoxworth Blood Center ................................................................................ 113

Material submitted for the record by:

American Association of Blood Banks, material dated December 22, 1997,

submitted for the record ............................................................................... 46

Plaisier, Melinda, Associate Commissioner for Legislation, Food and Drug

Administration, letter dated November 23, 1999, to Hon. Fred Upton,

enclosing response for the record ................................................................ 85

Upton, Hon. Fred, Chairman, Subcommittee on Oversight and Investigations:

Letter dated October 21, 1999, to Hon. David Satcher, enclosing

question for the record and response to same ..................................... 81

Letter dated November 1, 1999, to Hon. David Satcher, enclosing

questions for the record and response to same ................................... 83

(III)

(1)

BLOOD SAFETY AND AVAILABILITY

THURSDAY, SEPTEMBER 23, 1999

HOUSE OF REPRESENTATIVES,

COMMITTEE ON COMMERCE,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 10 a.m., in room

2322, Rayburn House Office Building, Hon. Fred Upton (chairman)

presiding.

Members present: Representatives Upton, Cox, Bilbray, Ganske,

Bryant and Strickland.

Staff present: Alan Slobodin, majority counsel; Anthony, Habib,

legislative clerk; Chris Knauer, minority counsel; and Brendan

Kelsay, minority clerk.

Mr. UPTON. Good morning, everyone. I apologize in advance for

my cold, my bad ears.

This morning the subcommittee holds the first of three oversight

hearings on the safety and availability of the U.S. blood supply.

The issue of the blood supply is not a remote one to any of us.

Every 3 seconds, a person needs blood. Michigan hospitals, as one

example, use a pint of blood every 43 seconds. According to one estimate, 95 percent of us will need a blood transfusion by the time

we’re 75. And we expect the blood to be there and for it to be safe.

Recently, we have seen some anecdotal reports about blood shortages during certain times of the year in some areas of the country.

We have heard about elective surgeries postponed because of blood

shortages and increased risks to patients who may have an immediate need for a transfusion. In one example last year, one third

of the 38 American Red Cross blood regions were down to only a

day’s supply of type O blood and nine regions were on emergency

appeal, meaning they had less than 1 day’s supply of type O blood.

In another example, this past winter about half of all U.S. blood

banks had less than a day’s supply.

In looking at the long-term trend, an internal memo dated July

2 of this year from the NIH noted, ‘‘A gradual decline has occurred

in blood donation by the U.S. general population over the past 10

years.’’

Another internal NIH memorandum dated August 6, 1999,

states, ‘‘There is an immediate need to monitor the blood supply for

adequacy. The time is approaching when supply will become a safety issue.’’

I ask unanimous consent that both of these memoranda be inserted in the record in their entirety.

[The information referred to follows:]

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TO: Ruth Kirschstein, M.D., Deputy Director, NIH

FROM: Director, NHLBI

SUBJECT: Monitoring the US Blood Supply

In following up to Dr. Sachter’s memorandum of July 22, the NHLBI concur with

the importance assigned to monitoring the adequacy of the US blood supply, especially in view of the imminent deferral of potential donors who have spent time in

the United Kingdom.

The Institute is prepared to respond by arranging for monthly data collection from

a sample of blood collection centers, with analysis focusing on trends and possible

seasonal shortages. If Feasible, data will also be collected from transfusion services,

emphasizing the detection of shortages, if they occur, and their adverse effects, if

any, on patient care. The mechanisms by which this data collection will be supported are under review, but the cost seems unlikely to exceed $300,000 annually

and may be somewhat less.

Other PHS Agencies and parts of the private sector will be involved to ensure that

the data meet the needs of the government and of the blood collectors and that

there is a smooth transition between procedures used to satisfy immediate requirements and a long term solution to providing necessary blood data.

CLAUD LENFANT, M.D.

cc:

Dr. Alving

Dr. McCurdy

DEPARTMENT OF HEALTH & HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

MEMORANDUM

Date: August 6, 1999

From: George J. Nemo, Ph.D.

Paul R. McCurdy, M.D.

Subject: Blood Data

To: Director, NHLBI

Through: Director, DBDR

The PHS has an immediate need to monitor the nation’s blood supply for adequacy. This action is necessary to determine the effect of deferring blood donors who

have spent an aggregate of 6 or more months in the UK between 1980 and 1996.

This deferral policy will be activated by an FDA Guidance document which is expected to be released by the end of August. Other safety-related initiatives such as

the recent introduction of nucleotide amplification technology (NAT testing) are also

likely to have an adverse effect on supply, while improving safety. The time is approaching when supply will become a safety issue.

The NHLBI has long been aware of the limitations on information about the collection and transfusion of blood. The Institute supported the data system of the

American Blood Commission (ABC) in the late 70s, but with drew that support because the ABC tried to accomplish too much and failed to provide useful data in

a timely fashion. One of the NHLBI SCOR programs in Transfusion Medicine provided considerable information for over a decade on the collection and use of blood

in the U.S. These data were not obtained frequently enough, however, for decisionmaking purposes. The Institute also sponsored a workshop on blood data in 1989,

but its recommendations were never implemented.

To be most helpful, data to be collected must be carefully determined and examined in the light of detecting seasonal and other changes in supply and demand for

blood and its components. Thus, setting up data collection and analysis is a research

activity and well within the purview of the NHLBI. It is anticipated that in the future, most likely in FY2002, the data system will be established to be contracted

for management by another agency as a service (e.g., CDC).

Hence, it is recommended that the NHLBI support through appropriate mechanisms blood data collection and analysis to evaluate ways of accomplishing this activity and to support necessary initiatives to improve blood safety while maintaining

an adequate supply.

Attached is a note addressing several issues relating to blood data collection and

analysis and a plan for the Institute to obtain blood data on a timely basis.

cc: Ruth Kirschstein, M.D.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

August 3, 1999

TO: Assistant Secretary for Health and Surgeon General

FROM: Deputy Director, National Institutes of Health

SUBJECT: Procedures to Monitor the Blood Supply

Dr. Varmus has asked me to respond to your memorandum of July 21. Following

the meeting of the Blood Safety Committee on June 8, at which there was much

discussion about the likely reductions in the number of blood donations in the

United States, I met with Dr. Claude Lenfant, Director, National Heart, Lung, and

Blood Institute (NHLBI) , the staff of its Division of Blood Diseases and Resources

and Dr. Paul McCurdy, a consultant to Dr. Lenfant and to me. The following plan

is the result of those discussions:

The plan consists of six discrete activities, three of which, currently supported

by NHLBI, will be continued and three proposed new ones which can be implemented after approval by the National Advisory Council of the Institute. Descriptions of the research plan are attached.

The current expenditures for FY1999 for the ongoing projects, #1, 2, and 6 and

the total proposed for FY2000 are:

FY99 FY2000

#1 and 2 ...................................................................................................................... $1,137,500 $500,000

#6 ................................................................................................................................. $180,000 Not determined as yet

The new projects, #3, 4, and 5, if approved by the Council, will start in fiscal year

2000 and are projected to be:

FY00 ........................................................................................................................................................................ $1,638,347

FY01 ........................................................................................................................................................................ $1,638,347

FY02 ........................................................................................................................................................................ $1,165,786

As these studies progress, and in some cases, start, NIH will work with your office

and the Blood Safety Committee to assess the need for, and types of studies, to be

planned regarding blood donations.

RUTH L. KIRSCHSTEIN, M.D.

Attachment

July 2, 1999

NHLBI RESEARCH PLAN TO INCREASE THE U.S. BLOOD SUPPLY

With demand for blood increasing and supply decreasing, the AABB National

Blood Data Resource Center estimates that overall demand will exceed supply in the

year 2000. The recent decision of the U.S. Public Health Service to recommend deferral of donors who have visited and/or resided in the United Kingdom and the Republic of Ireland for a cumulative period of six months or greater between 1980 and

1996 will likely contribute to this problem.

Understanding why people donate blood is paramount to insuring the adequacy

and safety of the blood supply. The National Heart, Lung, and Blood Institute

(NHLBI) through its Retrovirus Epidemiology Donor Study (REDS) plans to conduct

a survey of donor motivations. Furthermore, the Institute plans to evaluate the use,

effectiveness, and safety of blood donation incentives. A study is also being developed to determine the feasibility of increasing the frequency of donations in repeat

blood donors by one donation per year. A longitudinal study is being planned on the

recruitment and retention of blood donors. Another project is being planned to determine the feasibility and cost effectiveness of using double red blood cell collection

by apheresis as a means of increase red cell donations. The Institute is also supporting a study that is evaluating a computer-assisted interactive video donor

screening system. Brief descriptions of these studies follow.

1) Evaluation of the Impact of Recruitment Strategies on Blood Donation Behavior

Extensive literature exists on ways to recruit blood donors. However, few attempts

have been made to study the real-time interactions of blood centers with their donors on a large scale, or to conduct controlled experiments to determine the positive

and negative impact of specific recruitment programs, especially those offering various forms of incentives. The primary goal of this study is to produce measurable

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improvement in donor recruitment efficiency as measured by new and repeat donation behaviors in those subgroups, while monitoring any major changes in deferrable

risk.

In Phase I of the study, REDS will interact closely with a small group of mobile

blood collection units for approximately 6 months. The recruitment strategies used

for donors at a sample of these mobile units such as telerecruiting, direct mailing,

and media appeals will be documented and donor responses to these recruitment

strategies will be measured. A combination of mail and on-site survey techniques

will be used to measure prevalence of deferrable risk and, donor attitudes and responses to recruitment practices.

Based upon data derived from previous REDS Donor surveys and available data

from Phase I, four REDS blood centers will implement and evaluate experimental

incentive programs in Phase II of the study. In this phase, specific incentives and

promotional strategies such as cholesterol testing, gifts, or time off from work will

be provided to the same mobile units, with the goal of measuring the positive and

negative impact of these specific interventions. Prevalence of deferrable risk and recruitment efficiency among sites that implemented new incentives programs will

then be measured and compared to similar data obtained in Phase I before implementation of the incentives. The survey instruments for this study are being developed. It is anticipated that the documents will be submitted to the office of Management and Budget (OMB) in October 1999 and the study initiated in January 2000.

2) Study of donor Motivations

Little appears to be known about what motivates some people to become regular

blood donors, or why only about 39 percent of first-time donors return. Adequate information pertaining to donor motivation in various ethnic groups is also lacking;

data which would be valuable for minority recruitment efforts. With the current difficulties in maintaining an adequate blood supply, it is important to discern the reasons behind people’s decisions to donate, so that better recruitment strategies can

be formulated.

The REDS group is in the process of developing a donor survey to examine motivational factors. The survey will be conducted at all five REDS blood centers at both

fixed and mobile recruitment sites. Donors will be presented with a questionnaire

to be completed during the donation process. Previous REDS donor surveys have

yielded low response rates from certain groups of donors, such as first timers, minorities, and the young. It is thought that using the approach of surveying donors

while they are still at the center will increase response rates for these groups and

be of minimal cost.

Approximately 37,000 donors will be surveyed over a 6-month period at the five

REDS centers. The survey will be identity-linked to enable follow-up of donors in

the REDS donation database. This will permit REDS investigators to compare actual donation behaviors to stated intent. Questions pertaining to motivational factors and demographic data will be collected. Blood centers will also track incentive

use and recruitment techniques at both mobile and fixed sites to permit evaluation

of the association between actual exposure to incentives and reported donor motivational factors. The survey document is currently being developed and will be submitted to the OMB in October 1999. The study is scheduled to begin January 2000.

3) Study to Increase Blood Donations

A study is being planned within REDS to increase the frequency of blood donations in repeat blood donors by one donation per year. For many years, data have

repeatedly shown that most blood donors give but once a year (50-70%, most recent

REDS data). If a second blood donation is given within 1-2 years of the first, the

individual is more likely to become a ‘‘regular donor,’’ defined as one who gives

every 1-2 years for several years. It is hypothesized that arranging for donors who

give 1-2 times yearly to donate blood once more per year is feasible and will increase

the blood supply and eliminate shortages.

The study would be conducted in two or more REDS blood centers. For a sample

of a blood center’s fixed and mobile sites, arrangements would be made for each

donor, while resting in the canteen after donating, to make an appointment for the

next donation (after 3-6 months). A reminder (card and/or call) will be sent before

the appointment. Control sites will have no such appointment plans. Endpoints

would be the number of donations at the test sites with an appointment system,

compared with those sites who use current procedures. This study will be conducted

at two REDS blood centers and is scheduled to be completed in two years.

4) Study on the Recruitment and Retention of Blood Donors

A gradual decline has occurred in blood donation by the U.S. general population

over the past ten years. As a result, recruitment and retention of donors is a top

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priority for virtually all of the nation’s blood collectors and each blood center now

spends an increasingly large proportion of their overall resources to maintain the

current supply.

What appears to be missing from this intense recruitment activity is a structured

approach to understanding the reasons why sub-populations of donors appear for donation the first time, and why they appear for return donations with varying levels

of frequency. When stratified by demographic subgroups, improved understanding

of these factors should help to inform the design of experimental studies and demonstration projects related to recruitment and retention and allow rapid transfer of

information to the field.

At the five REDS centers and three additional blood centers (chosen to represent

the overall U.S. population), a representative sample of approximately 25,000 active

donors will be invited to participate in a linked study of blood donation patterns.

The follow-up of each donor will last for two years. Two weeks following enrollment

and at six month intervals thereafter, mail surveys will be sent to study participants to gather information about donation experiences, blood donation recruitment

exposures (ads, telephone calls, sponsored donations, incentive offerings, etc.), reactions to these exposures, rationale for becoming a donor in the first place and actual

or intended post-enrollment donation.

A subset of this study will involve the over sampling (an additional 10,000) of college-age donors to participate in a similar, but more targeted version of this study.

Surveys distributed to this subset of donors will include questions about donations

made during high school, donation patterns of their parents, how they were first introduced to the donation experience, and what types of opportunities, fed back, or

appeals will encourage them to become lifetime donors.

5) Feasibility of Increasing Red Cell Donations using Apheresis Procedures

This project will study the use of double red blood cell (2RBC) collection by

apheresis as a means to increase red cell donations. The 2 RBC procedure collects

the equivalent of two whole blood derived packed RBC units from one donor in a

single procedure. Donors who give typically only once or twice a year, if recruited

to give 2RBC donations would effectively double their donations. This would be of

particular value for Rh negative donors and those with blood types always needed

such as group O.

Practical limitations have existed in the length of time required for 2RBC donations (35-40 min.), donor size and hematrocrit requirements, and relative cost of the

procedure. The costs of disposable collection equipment, however, have begun to decline. The purpose of this project would be to demonstrate the feasibility of converting whole blood donors to 2RBC donors, and that this conversion can be performed in an economically feasible manner. This project will be conducted at two

blood centers and is scheduled to be completed within two years.

6) Computer-assisted Interactive Video Donor Screening

The Institute is supporting a grant program to develop an interactive, multimedia

video blood and plasma donor health history system; and to evaluate its acceptance

and feasibility in operational settings. The principal aims of the program are to improve overall operational systems for screening donors and collecting blood and plasma; and to improve the safety of blood and plasma supplies. these aims will be evaluated in two stages. In the initial stage, the interactive video screening software

will have no decision logic and the nursing staff will determine donor suitability

from the printed output of the screening system. In the final stage, it is planned

to integrate the interactive video donor screening system into the data management

system of the donor center resulting in a ‘‘paperless’’ health history assessment.

Mr. UPTON. We have become concerned, as have the blood banking community and public health experts, about the apparent tightening of the blood supply. There seem to be several factors that are

contributing to this trend of an apparent tightening of our blood

supply: A growing population over 65 that will need more operations and thus more blood transfusions, younger generations donating at lower rates than the past generations, and improved

screening and testing, to name just a few.

Officials in both the blood banking community and the government have raised concerns about these trends. In response to these

concerns, Chairman Bliley asked the GAO to conduct an assessment of the availability of the U.S. blood supply. We look forward

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to hearing the GAO’s testimony on the supply and the demand

trends.

We’re also pleased to have two experts, Marian Sullivan of the

National Blood Data Resource Center and Dr. James AuBuchon, of

the Dartmouth-Hitchcock Medical Center, who will also discuss the

matter.

At the same time concerns have been raised about the blood

shortages and the trends in the blood supply, a new Federal policy

will further decrease that blood supply. Last month, the FDA

issued a new policy that requires that individuals who spent a total

of 6 months or more in the United Kingdom between 1980 and the

end of 1996 be prohibited from donating blood because of concerns

over theoretical risk of spreading a new variant of CJD,

Creutzfeldt-Jakob Disease, or the human form of the mad cow disease.

This new donor exclusion policy was taken as a precaution since

little is known about this new variant of mad cow disease, how it

is transmitted, what the incubation period is and whether it is

transmissible through blood transfusions. However, the new policy

has been estimated to reduce the blood supply by 2.2 percent.

Chairman Bliley asked the GAO to analyze this policy and the

expected loss to the blood supply. The GAO will be testifying on

this new policy.

To alleviate blood shortages and especially to offset the expected

loss to the blood supply, the Department of HHS asked the FDA

and HCFA to identify a strategy to increase the blood supply by

easing restrictions on the distribution of blood collected from

hemochromatosis patients. This is an iron overload disorder that is

genetic and not a transmissible disease.

These patients are not less safe donors because of their disease.

However, because of their disease, these patients require blood removal as therapy and most patients are charged for the removal.

A concern is that a financial incentive to donate at no cost, rather

than having blood removed therapeutically, might cause the donor

to be less truthful about acknowledging risk behaviors.

Ways are being considered to remove financial incentives for

these patients. Chairman Bliley again asked the GAO to evaluate

the potential impact of a change in policy to allow units of blood

collected from these patients to be distributed. The GAO’s testimony before us today will cover this area as well.

We’re also pleased to hear the testimony from the Inspector General at HHS concerning error and accident reports. In May 1995,

the IG issued a report that concluded the FDA could improve the

safety of the blood supply by doing a better job of collecting data

on errors and accidents made by hospitals and blood banks.

The audit found that the FDA was not insisting that hospitals

and blood banks submit error reports in a timely fashion and that

FDA does not get these reports at all from unlicensed facilities that

handle about 10 percent of the blood used in the U.S. In contrast,

blood centers that account for about 80 percent of the blood supply

are covered by consent decrees that are required to submit error

and accident reports within 30 days.

The IG recommended that the FDA expedite regulations that

would be more specific about the timeframe in which reports are

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required to be submitted and that would require unlicensed blood

establishments to submit their reports. The IG will be testifying on

the status of the implementation of these recommendations.

Today we lay a foundation for oversight efforts. In future hearings, we will have witnesses from the Department of HHS, as well

as the FDA and from the blood banking community.

I was a member of this subcommittee in the early 1990’s when

we investigated the contamination of blood supply with the AIDS

virus. Since that time, a number of measures have been taken by

the government and the blood banks to provide greater assurance

of safety.

They have also been technological advances such as nucleic acid

testing and viral inactivation that could make the blood supply

even safer. This subcommittee will continue to oversee blood safety

vigorously, with a watchful eye on availability.

I look forward to working with my colleagues on this subcommittee, the administration, the blood banking community, the

public health and medical communities, and especially the patients

who receive blood transfusions, to provide absolutely the strongest

assurance possible for the safety and availability of the Nation’s

blood supply.

And I yield to my friend from Ohio, Mr. Strickland, for an opening statement.

Mr. STRICKLAND. Thank you.

I thank you, Mr. Chairman; and I want to thank you for holding

these hearings. This is an important issue. It could potentially affect every American citizen. And it is proper that we hold these

hearings to find out what we, as a Congress, need to do or can do

to make sure that our Nation’s blood supply is adequate and safe;

and I look forward to hearing from the witnesses. Thank you.

Mr. UPTON. Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman.

I want to welcome all of those in the audience, including our

panel of witnesses. I have reviewed the qualifications and certainly

we have a very distinguished panel who are competent to testify

about the issues that are before us today, which has been said already twice this morning, this is a very important issue for this

country.

I must apologize that sometimes we have overlapping schedules,

and I will be in and out today. We are downstairs marking up a

bill in another subcommittee on the Commerce Committee, on

which I serve as well, and on the floor with a bill that has to do

with class action litigation, something that is very near and dear

to my heart, and I will have a role in that.

So all that to tell you I must leave after making the statement.

But I will try and get back and hear some of the testimony. I would

like to be available to ask some questions.

I know there are issues out there, and there appears to be some

conflict among our witnesses as to the adequacy—the state of our

current Nation’s blood supply, the effect on the new FDA policy regarding transfusions—or not transfusions, but obtaining blood from

people who have been to England, and the reporting requirements,

all important matters that I’m sure this panel will discuss in detail.

8

But, again, I must apologize for missing this. I will have the opportunity to review your testimony if I should miss it. And I want

to especially thank the chairman of the Oversight Subcommittee,

Mr. Upton, for his foresight in having this hearing.

I mentioned to someone this morning as I came up, it’s about

blood safety, but you don’t think too much about that until you,

yourself, or someone in your family needs that blood, and then you

say I hope that blood is safe, and I trust that blood is safe.

But it’s good to have this hearing, and I appreciate, Mr. Chairman, you for calling this. And I yield back my time.

Mr. UPTON. Thank you.

Mr. Cox.

Mr. COX. Thank you, Mr. Chairman.

The FDA has told us—in fact, Commissioner Jane Henney—that

blood safety is one of FDA’s top priorities; and today the purpose

of our oversight hearing is to ensure that is and remains the case.

Four years ago, the Office of Inspector General at the Department of Health and Human Services completed a study and report

that recommended the FDA expand its use of error and accident

information; and, at the same time, the Public Health Service,

which is FDA’s oversight agency, agreed with that recommendation

and told Congress that there would be a proposed rule issued by

February 1996. But 11⁄2 years later, there still had not been a proposed rule issued.

Finally, in September 1997, that proposed rule was issued, but

we are told now that a rule in final form is going to be postponed

until sometime in 2001. And because we wish this to be a top priority, not a secondary priority, of FDA, we are concerned that the

reason given by FDA for delay of its final rule is ‘‘because of multiple public-health-related priorities of the agency’’. In other words,

this isn’t a top priority. That’s the way I understand FDA’s statement.

I’m sure we will be told today that it is and remains a top priority, but we will have to look to results rather than rhetoric. Error

and accident reports are the basis for FDA’s oversight of the blood

industry. Some 13,000 reports were filed last year, but there is indication that they are still not on an overall systemic basis being

provided promptly. Furthermore, those establishments that do not

shift blood interstate—and thus are not subject to the licensing regime—are not on a continuing basis, as was identified some 4 years

ago, submitting reports that provide data to FDA for its oversight

of the blood supply.

And when 10 percent of the blood supply is missing from this

equation, it raises obvious concerns of the establishments that are

unlicensed. Representing about 10 percent of the supply, they accounted for only 1 percent of the report. So either the situation

with these establishments is completely different than with all of

the licensed establishments or we are simply not getting the information from them, which is more likely the case.

So today’s hearing is properly focused on what FDA is doing now

and, even more importantly, what they’re going to do tomorrow

morning; and I think this panel of four is especially well-suited to

address those questions.

And I thank the chairman for scheduling the hearing.

9

Mr. UPTON. Thank you, Mr. Cox.

At this point it’s been noted we have a number of subcommittee

meetings this morning, and I would ask that all members of this

subcommittee under unanimous consent request be allowed to offer

as part of the record any opening statement that they may have.

At this point, without objection, so ordered.

[Additional statement submitted for the record follows:]

PREPARED STATEMENT OF HON. TOM BLILEY, CHAIRMAN, COMMITTEE ON COMMERCE

Mr. Chairman, thank you for these hearings concerning the safety and availability

of the Nation’s blood supply. Last June, I asked the General Accounting Office

(GAO) to conduct an assessment about the blood supply. I specifically asked the

GAO to provide: (1) information on recent trends in blood supply and demand, (2)

the expected impact on the blood supply by a new ban on donors who have traveled

to the United Kingdom, and (3) the potential impact on the blood supply from a

change in policy to make it easier to distribute units of blood collected from patients

with an iron overload disorder. I appreciate the GAO’s work and believe the GAO’s

findings will provide a sound foundation for this Subcommittee to investigate in a

careful, fair, and balanced manner. In addition, the Office of Inspector General (IG)

at HHS, will report to the Subcommittee on the status of FDA’s implementation of

the IG’s recommendations concerning certain blood safety reports.

However, today’s hearings about blood, and the hearings to come, mean more to

me than just facts and figures. It’s about people’s lives. It’s about a young married

couple, Bruce and Kristina Wenger, of Hanover, Virginia, who were the first unrelated partial liver transplant case in the United States.

Four years ago, Bruce was diagnosed with a rare liver disease. By the beginning

of 1998, Bruce was about to die from this disease and would have left his young

wife and infant son. But his wife, Kristina, volunteered to donate part of her liver.

Tests showed her liver was compatible. On Valentine’s Day 1998, 60 percent of

Kristina’s liver was removed and transplanted into Bruce. The transplant team was

led by Dr. Robert Fisher, director of the liver transplant program at Virginia Commonwealth University’s Medical College of Virginia.

During the operation Bruce received five pints of packed red cells. Kristina didn’t

receive any blood products: Her own blood was recycled. According to the blood bank

at the Medical College of Virginia, partial liver recipients use an average of 40 blood

products, including red cells, fresh frozen plasma and platelets.

Bruce is now back at work part time as an estimator for a homebuilder. Kristina

is a Captain in the Marine Corps Reserves and a full-time mom. Bruce was kept

alive for his son, Bruce Jr. And I am delighted to report that last week the Wengers

had their second child. The transplant, and the blood transfusion that made it possible, were gifts of life and love.

Throughout the years, hundreds of thousands of people in my district like Bruce

have needed blood during operations. The good news is that the blood supply has

never been safer, with more advances coming to improve blood safety. But blood still

has risks. We still must be vigilant on safety. However, the greater challenge now

appears to be on the supply side. Our task is to ensure that the blood is there and

that the blood is safe.

As we learn more about blood, and look at ways to improve the quantity and quality of the blood supply, my thoughts will be with the people. People like Bruce and

Kristina Wenger.

Mr. UPTON. At this point, we would like the witnesses to come

forward: Janet Heinrich, Associate Director of Health Financing

and Public Health Issues at GAO; Thomas Roslewicz, Deputy Inspector General for Audit Services at the Department of Health

and Human Services; Marian Sullivan, Executive Director of the

National Blood Data Resource Center; and James AuBuchon, Professor of Pathology and Medicine at Dartmouth-Hitchcock Medical

Center.

As you all know, this is a subcommittee where we take testimony

under oath. Do you have any objection to that?

[Witnesses sworn.]

10

Mr. UPTON. You’re under oath and you may have a seat. Your

statement will be made part of the record in its entirety. We would

like, if we can, to limit your statement or your opening to 5 minutes or so.

Dr. Heinrich, we will start with you. Thank you for coming.

TESTIMONY OF JANET HEINRICH, ASSOCIATE DIRECTOR,

HEALTH, EDUCATION AND HUMAN SERVICE DIVISION, GENERAL ACCOUNTING OFFICE; THOMAS D. ROSLEWICZ, DEPUTY INSPECTOR GENERAL FOR AUDIT SERVICES, ACCOMPANIED BY JOSEPH GREEN, ASSISTANT INSPECTOR GENERAL FOR AUDITS, PUBLIC HEALTH SERVICE AUDIT DIVISION, DEPARTMENT OF HEALTH AND HUMAN SERVICES;

MARIAN T. SULLIVAN, EXECUTIVE DIRECTOR, NATIONAL

BLOOD DATA RESOURCE CENTER; AND JAMES P.

AUBUCHON, PROFESSOR OF PATHOLOGY AND MEDICINE,

DARTMOUTH-HITCHCOCK MEDICAL CENTER

Ms. HEINRICH. Thank you very much.

Mr. Chairman and members of the committee, I am pleased to

be here today as you discuss the availability——

Mr. UPTON. If you could just move the mike just a little closer.

Thank you.

Ms. HEINRICH. As you discuss the availability of blood to meet

the Nation’s requirements, as well as recent and proposed FDA policy changes regarding blood donations.

At the committee’s request, we have examined trends in the Nation’s blood supply, the effect of a ban on donors who have traveled

to the UK and the potential effect of policy changes to allow blood

collected from people with hemochromatosis to be distributed. And

we did issue a report to you earlier this week.

I will focus on the trends in the blood supply and our analysis

of the policy changes recommended by HHS. We found that while

there is concern for shortages of certain blood types, seasonal patterns and occasional shortages in certain regions of the country,

the blood supply, as a whole, is not in crisis. The blood supply has

decreased over the last decade, and there is some evidence that, in

recent years, the demand for blood has increased. However, any

conclusions about the trend in the blood supply are hampered because information about the supply has not been gathered routinely. The last survey was conducted in 1998.

The total decrease in units collected between 1994 and 1997 was

5.5 percent, according to the National Blood Data Resource Center.

Most of this decline was in donations targeted for specific individuals, especially autologous collections taken from individual patients for personal use prior to surgery, rather than in the allogenic

or community supply of blood available to anyone.

During the same period, there was a decrease in the community

supply of about 2 percent. We believe that the NBDRC study overstates the decline in the blood supply. Overall, the blood banking

system had an adequate supply to meet increasing demand as total

units transfused increased by 3.7 percent during the same period.

The supply cushion is growing smaller. Blood centers gave us

data showing less than 1 day’s supply on hand for some blood

types, such as O & B in some regions this summer. Blood centers

11

have no incentives to collect more blood than can be used. In 1997

only about 4 percent of the allogenic blood supply expired before

being transfused.

With 93 percent of available supply used in transfusions, blood

centers state that they are below the comfort level in many regions.

Blood banks can mitigate the effects of local blood shortages by

transferring blood from regions with an excess supply to those with

shortages. The American Association of Blood Banks National

Blood Exchange and the American Red Cross together moved about

1.1 million units of blood between blood centers last year.

Estimates of the future demand for blood are uncertain. Blood

banks want to ensure that trauma patients and others who may require many units of blood can be promptly treated whenever the

need arises. Persons that are 65 and older receive twice as much

blood per capita as young individuals, so we do expect that the

aging population may increase the demand. Further, the number

of surgical procedures that require blood or blood products are increasing.

On the other hand, some evidence indicates that the use of blood

can be substantially reduced without effecting clinical outcomes.

For example, the amount of blood used for hospitals vary widely,

and at least one pilot program has shown that the use of blood can

be substantially reduced without affecting the clinical outcomes.

Improved surgical techniques and better understanding of the

clinical thresholds that trigger blood transfusions has reduced the

demand for blood in some instances as well.

In response to concerns for the safety of the blood supply, FDA

has issued a guidance recommending that collections be prohibited

from donors who traveled or resided in the UK for a total of 6

months or more between 1980 and 1996 because of the theoretical

risk of transmitting new variant CJD through blood transfusions.

Transmission by blood in humans has not been documented, although animal research suggests that infection by blood is theoretically possible. The 6-month residence interval was selected to balance the twin goals of minimizing losses in blood and eliminating

as much risk as possible.

Would you like me——

Mr. UPTON. If you can.

Ms. HEINRICH. [continuing] to summarize?

Mr. UPTON. Yes, that would be great.

Ms. HEINRICH. The other policy that you asked us to evaluate

was making hemochromatosis patients available to donate blood.

We estimate that that might mean that we have 300,000 units, 3

million units, it’s very hard to estimate exactly how much. There

are concerns, though, about financial incentives for these individuals to donate blood because of the issues of cost incentives that

must be addressed before the inclusion of hemochromatosis patients blood enter the community supply. We are concerned about

how quickly this blood would be available.

This concludes my prepared statement, Mr. Chairman. I will be

happy to answer any questions.

[The prepared statement of Janet Heinrich follows:]

12

1 Blood Supply: Availability of Blood to Meet the Nation’s Requirements (GAO/HEHS-99-187R,

Sept. 20, 1999). 2To be eligible to donate, a person should be at least 17 years of age, weigh at least 110

pounds, be in good physical health, and pass a physical and medical history examination.

PREPARED STATEMENT OF JANET HEINRICH, ASSOCIATE DIRECTOR, HEALTH FINANCING AND PUBLIC HEALTH ISSUES, HEALTH, EDUCATION, AND HUMAN SERVICES DIVISION, GAO

Mr. Chairman and Members of the Subcommittee: I am pleased to be here as you

discuss the availability of blood to meet the nation’s requirements as well as recent

and proposed policy changes regarding blood donation that may affect the future

supply.

A recent report by the National Blood Data Resource Center (NBDRC), a group

representing blood banks, projected that the demand for blood will outstrip the

available supply by next year. At the same time, the Department of Health and

Human Services (HHS), which oversees the nation’s blood supply, has initiated a

major policy change—and is considering another—that could further affect the blood

supply. Specifically, the Department’s Food and Drug Administration (FDA) has recommended prohibiting blood donations from individuals who spent a total of 6

months or more in the United Kingdom between 1980 and the end of 1996 because

of concerns over the possible transmissibility of new variant Creutzfeldt-Jakob disease (nvCJD), the human form of ‘‘mad cow’’ disease. HHS has also proposed removing barriers to donation by individuals with hemochromatosis—an iron-overload disease that may be treated by drawing blood—to make up some of the loss in blood

donations from the decreases in donations and losses that may result from the U.K.

donor exclusion.

In light of these developments, you asked us to discuss the results of our recent

correspondence on the blood supply.1 In that report, done at the Committee’s request, we provide information on (1) recent trends in blood donation and the demand for blood transfusions, (2) the expected effect of a ban on donors who have

traveled to the United Kingdom, and (3) the potential effect of policy changes to

allow units of blood collected from individuals with hemochromatosis to

bedistributed. The points I will present today are discussed in more detail in the

correspondence.

In summary, we found that, while there is cause for concern about shortages of

certain blood types or in certain regions, the blood supply as a whole is not in crisis.

We believe that the NBDRC study overstates the decline in the blood supply. Most

of the decline found by NBDRC was in donations targeted for specific individuals,

rather than in the community supply of blood available to anyone in need. Further,

the projection of a shortage relies on data from only 2 years. The U.K. donor exclusion policy has been estimated to reduce the blood supply by approximately 2.2 percent. Blood banks fear that the actual loss due to this exclusion will be greater, but

it is not possible to assess the validity of their concerns. Estimates of the potential

increase in the blood supply from donations by individuals with hemochromatosis

vary widely, from 300,000 to 3 million units. Regardless, use of such donations will

require changes to current regulations, which may delay their availability for some

time.

BACKGROUND

About 8 million volunteers donate approximately 12 million units of whole blood

each year. Sixty percent of the population is eligible to donate, and about 5 percent

of the eligible population actually donate each year.2 There are four sources of whole

blood from volunteer donors for transfusion. The first, allogeneic donations, is the

most important category, accounting for roughly 90 percent of the blood supply.

Blood from allogeneic donations is available to any patient in need, and efforts to

increase the blood supply usually focus on increasing participation in blood drives

or otherwise raising the number of allogeneic collections. Second, autologous collections involve blood taken from patients before a medical procedure for their own

use. Third, directed collections involve blood donated for use by a particular patient.

A small portion of the autologous and directed collections ultimately are ‘‘crossed

over’’ to the general supply. Finally, less than 2 percent of the total blood supply

is imported.

Blood banks maintain a supply cushion to meet the uncertain demand for blood.

Local demand for particular blood types varies over the course of the year, and blood

banks want to ensure that trauma patients and others who may require many units

of blood can be treated promptly whenever the need arises. The supply cushion

13

3There are two genetic mutations, C282Y and H63D, associated with hemochromatosis.

C282Y is considered the major mutation; fewer data are available on the prevalence of

hemochromatosis in other populations. 4This projection did not consider the consequences of excluding travelers to the United Kingdom from donating blood or of any other policy changes that may affect the blood supply. 5The number of autologous and directed units collected but not transfused dropped 63 percent

between 1994 and 1997.

means that some blood is discarded—in 1997, for example, about 4 percent of the

allogeneic blood supply expired without being transfused.

New variant CJD is a chronic, progressive neurodegenerative disease that is inevitably fatal. It has a long, but unknown, incubation period. As of August 1999,

there had been 43 confirmed cases—41 in the United Kingdom, 1 in France, and

1 in Ireland. It is suspected that all of these individuals contracted nvCJD from eating contaminated tissues from cattle infected with bovine spongiform

encephalopathy (‘‘mad cow’’ disease) in the United Kingdom, probably prior to 1990.

Estimates of the number of U.K. residents who will ultimately manifest nvCJD

range from the hundreds to more than 500,000. In the United States, there have

been no documented cases of nvCJD.

Hemochromatosis is the most common genetic disease in Americans of European

descent—about 1 in 10 may carry the gene for this disease, and as many as 1 million Americans have evidence of hemochromatosis.3 The proportion of individuals,

however, who have the mutations associated with hemochromatosis and later develop the disease is unknown because not all of these individuals become ill. Treatment of hemochromatosis has two phases: (1) iron depletion therapy, in which the

patient receives a therapeutic phlebotomy, or drawing of blood, about 1 to 2 times

a week for several months up to 3 years to remove excessive iron stores, and (2)

maintenance therapy, in which the patient continues to undergo therapeutic

phlebotomies but less frequently (2 to 6 times a year) to keep body iron stores low

and iron levels normal for the remainder of the patient’s life.

RECENT TRENDS IN SUPPLY AND DEMAND

The blood supply has decreased over the last decade, and there is some evidence

that in recent years the demand for blood has increased. However, any conclusions

about the trends in the blood supply are hampered because information about the

blood supply has not been gathered routinely. The last systematic survey of the

blood supply was conducted by NBDRC in 1998, which measured units collected and

transfused in 1997. NBDRC will release the results of a new survey of blood collections this November, and the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) has recently arranged for NBDRC to collect data

on blood donations on a monthly basis from a sample of blood centers.

Earlier this year, NBDRC projected that the demand for blood will outstrip supply

by next year.4 We found that current evidence indicates the blood supply has declined more slowly than assumed for that projection. NBDRC’s projection rests on

the overall 5.5 percent decrease in the blood supply from 1994 to 1997, and on the

observed 3.7 percent increase in the number of units transfused during those years.

(See table 1.)

Table 1: Blood Supply Trends

1989 1992 1994 1997

Percent

change

(1994-1997)

Total units collected ............................................. 14,229,000 13,794,000 13,340,000 12,602,000 -5.5

Total community supply ........................................ 13,296,000 12,303,000 12,075,000 11,837,000 -2.0

Total units transfused .......................................... 12,059,000 11,307,000 11,107,000 11,517,000 +3.7

Our analysis of the blood supply data found that the 5.5 percent figure suggests

a more serious decline than actually occurred in the community supply of blood

(available to anyone in need). Most of the 5.5 percent decrease came from a drop

in blood not included in the community supply, which decreased only about 2 percent from 1994 to 1997. The number of units designated for particular transfusion

patients, both autologous and directed donations, decreased by 37 percent from 1994

to 1997, accounting for two-thirds of the overall 5.5 percent decline. Indeed, there

was an even larger decline in the number of such units that had been collected but

not used.5

14

6 Among all hospitals responding to the survey, the mean number of days with surgeries cancelled was 0.44 and the mean number of days with unmet nonsurgical blood requests was 2.1.

While other evidence seems to indicate that the blood supply cushion has narrowed, it is difficult to determine if shortages are worse now than in earlier years

because blood banks have no incentive to collect more blood than can be used. The

American Red Cross informed us that the number of days’ supply decreased below

the comfort level in many of its centers and gave us data showing less than 1 day’s

supply on hand for some blood types in some regions at one point this summer.

America’s Blood Centers reported anecdotal evidence of shortages in many of its affiliated blood banks this year. Shortages occur more frequently in some regions, as

do shortages of blood types O and B. Furthermore, the 1998 NBDRC survey found

that at least some surgeries and medical procedures have been postponed due to

blood shortages. Specifically, 8.6 percent of the hospitals surveyed indicated that

elective surgeries were cancelled on 1 or more days in 1997 due to blood shortages;

24.7 percent of hospitals said that they were unable to meet nonsurgical blood requests on 1 or more days in 1997.6

Blood banks can mitigate the effects of local blood shortages by transferring blood

from regions with an excess supply to those with shortages. The American Association of Blood Banks’ National Blood Exchange and the American Red Cross together

moved about 1.1 million units of blood between blood centers last year. This blood

is purchased by centers in shortage areas from centers with surpluses of particular

types of blood.

Estimates of the future demand for blood are also uncertain. On the one hand,

persons aged 65 and older receive twice as much blood per capita as younger individuals, so the aging of the population may increase the demand for blood products.

Further, some procedures requiring blood are being performed with increasing frequency, and the range of treatments requiring blood or blood products is increasing.

On the other hand, some evidence indicates that the use of blood can be substantially reduced. The amount of blood used for the same procedures varies widely

among hospitals, and at least one pilot program has shown that clinical outcomes

would not be affected if the use of blood were substantially reduced. Similarly, improved surgical techniques and better understanding of the clinical thresholds that

trigger blood transfusions has reduced the demand for blood in some instances.

EXPECTED EFFECT OF EXCLUDING DONORS WHO HAVE RESIDED OR TRAVELED IN THE

UNITED KINGDOM

Last month, FDA issued guidance recommending that collections be prohibited

from donors who had traveled or resided in the United Kingdom for a total of 6

months or more between 1980 and 1996—because of the theoretical risk of transmitting nvCJD through blood transfusions—which has raised concern among some

about the effect such a policy would have on the blood supply. FDA will review this

policy at 6-month intervals, to consider any new scientific information and the policy’s effect on the blood supply.

While it has not been shown that nvCJD is transmissible by blood transfusion,

animal research suggests that infection by blood is theoretically possible—in some

cases, direct injection of blood from a contaminated animal into the brain of another

has caused infection. However, no cases of transmission by blood in humans have

been documented. In the United Kingdom, 4 donors subsequently diagnosed with

nvCJD gave blood that was transfused into 10 recipients. None of these recipients

have developed nvCJD to date, although they may later because of the long incubation period.

Effect on the Blood Supply

The 6-month U.K. residence interval was selected to balance the twin goals of

minimizing losses to the blood supply and eliminating as much risk as possible. A

survey of blood donors by the American Red Cross found that 23 percent of donors

had traveled to the United Kingdom between 1980 and 1996. Only one-fifth of the

blood-donor travelers had been in the United Kingdom for more than 30 days, and

just 1 in 10 of them had a cumulative stay of 5 months or more. The Red Cross

analysis estimated that the 6-month exclusion criterion would result in a 2.2 percent reduction in the blood supply and eliminate 87 percent of the risk of collecting

blood from a person infected with nvCJD.

Blood banks have expressed concern that this exclusion will result in more than

a 2.2 percent loss. First, there is the possibility that some potential donors will fail

to attend to the details of the policy and not donate blood even though they are eligible to do so. For example, donors who traveled to the United Kingdom only in

15

7 Hemochromatosis is a disease of iron regulation that results in excessive iron absorption and

accumulation, leading to organ damage. The human body cannot excrete excess iron, so it remains in the body unless it is lost through menstruation, childbirth, hemorrhage, or blood donation. Iron is highly toxic when an excessive amount is absorbed. Some clinical chronic conditions

associated with hemochromatosis include severe fatigue, diabetes mellitus, heart disease, cirrhosis of the liver, and cancer. 8Therapeutic phlebotomy is the removal of a full unit of blood from an individual, about 500

mls, for the purpose of treating a disease. 9S. M. McDonnell and others, ‘‘A Survey of Phlebotomy Among Persons With

Hemochromatosis,’’ Transfusion, Vol. 39 (1999), pp. 651-6.

1997 may stop donating even though they remain eligible to do so. Second, there

is concern that potential donors may become discouraged because their friends or

neighbors are excluded, heightening the sense that it is difficult to pass all the

screening criteria for giving blood. Third, there is worry that excluded U.K. travelers

will not return to donate blood if, and when, the restriction is lifted.

Blood banks are also concerned about other burdens imposed by this exclusion.

For example, according to research conducted by the American Red Cross, donors

who resided or traveled in the United Kingdom are disproportionately repeat donors. Without these donors, the blood banks will need to recruit a large number of

first-time donors to replace them because first-time donors are roughly twice as likely to have disqualifying medical conditions as regular donors. Second, the effect will

vary by blood center, as those with a larger proportion of U.K. travelers will lose

more of their donors than other blood collection centers. The Red Cross survey found

that the proportion of donors affected in some blood centers were 35 percent greater,

and others 50 percent less, than the overall average.

Risk Reduction

Estimates of the degree of risk reduction achieved by this exclusion are problematic. First, the degree of potential risk to be mitigated is unknown. Second, because

the prohibition applies only to future donations, some blood from donors who would

now be excluded has entered the blood supply in the recent past. Third, because so

little is certain about how nvCJD is acquired, estimates of the beneficial effect of

any prohibition threshold—other than a complete ban on potential donors who have

traveled to the United Kingdom at all—are uncertain. For example, the Red Cross

estimate assumed that the risk of acquiring nvCJD increased directly with each day

spent in the United Kingdom. Any change in this assumed relationship would lead

to a significantly different risk reduction estimate. Indeed, HHS told us that the Department did not totally agree with the Red Cross risk formulation and that its

choice of the 6-month threshold was based on other information. In particular, HHS

told us that all of the individuals in the British cases (41 of the 43 known cases)

were born in the United Kingdom and resided there for at least 10 years between

1980 and 1996; thus, the Department reasoned that any exclusion threshold of 1

year or less would reduce the presumed risk tenfold or more.

POTENTIAL FOR BLOOD DONATIONS FROM INDIVIDUALS WITH HEMOCHROMATOSIS

In April 1999, the Public Health Service’s Advisory Committee on Blood Safety

and Availability recommended that policy changes be made to allow blood collected

from individuals with hemochromatosis to be distributed for transfusion.7 Making

hemochromatosis patients eligible to donate would essentially guarantee an increased number of donors because they have to periodically have blood drawn to

treat their condition. Members of the advisory committee concluded that blood products from individuals with hemochromatosis carry no known increased risk to recipients. Therefore, they recommended that HHS change its policies and remove any

barriers to the use of this blood. At the same time, the advisory committee recommended that HHS take steps to eliminate any financial incentive for these individuals to donate blood. Since individuals with hemochromatosis may have to pay

to have their blood drawn through therapeutic phlebotomy, 8 there would be a financial incentive to avoid this cost by donating blood. Unless this incentive is removed,

FDA is concerned that these potential donors will not truthfully answer screening

questions about risk factors that would disqualify them from donating, thereby compromising the safety of the blood supply.

According to one survey, most individuals with hemochromatosis are insured or

partially insured for therapeutic phlebotomies. However, even though therapeutic

phlebotomies are necessary medical treatment for some individuals, insurance does

not always cover the costs. The average cost of the procedure per unit of blood

ranges from $52 at blood centers to $69 at physician offices and $90 at hospitals,

with an average out-of-pocket cost of $45 for all respondents to the survey.9 These

16

10S. M. McDonnell and others, ‘‘A Survey of Phlebotomy Among Persons With

Hemochromatosis.’’ 11The processing of whole blood units into packed red cells removes most of the iron-enriched

serum. 12Data show that blood from paid donors is more likely to transmit disease than that from

volunteer donors; R. A. Sacher, ‘‘Hemochromatosis and Blood Donors: A Perspective,’’ Transfusion, Vol. 39 (1999), pp. 551-4. 13The American Association of Blood Banks has also indicated that, if FDA changes the regulations, it would make changes to its standards related to the use of blood from patients with

hemochromatosis, so that centers could remain in compliance with the association’s requirements.

out-of-pocket costs are a financial incentive for persons with hemochromatosis to not

disclose any disqualifying conditions and volunteer for blood donations. In one

study, 37 percent of the hemochromatosis patients surveyed reported being voluntary donors before their diagnosis and 54 percent of the individuals attempted to

donate blood after diagnosis.10 The results from the National Donor Research and

Education Study sponsored by NIH show that about half of the individuals who responded that they had hemochromatosis (only 0.4 percent of those surveyed) were

volunteer donors. At present, there is no routine screening for this disease.

In the United States, blood obtained by therapeutic phlebotomy from individuals

with hemochromatosis is currently discarded. Although hemochromatosis is inherited, not transmitted, and there is no evidence that the use of hemochromatosis

blood for transfusion carries any risks to the recipients, 11 hospitals and physicians

hesitate to use this blood. FDA permits the use of blood from individuals with

hemochromatosis, as long as they meet the same donor suitability criteria as any

other donor, but it requires that this blood be labeled as coming from a

hemochromatosis donor, which effectively impedes the use of this blood. Some in the

U.S. blood industry consider hemochromatosis donors to be the same as paid donors,

implying a decreased level of safety.12 In 1996, the American Association of Blood

Banks issued standards discouraging transfusion of blood from donors who had

therapeutic phlebotomies. Because many blood centers conform to these standards,

this policy effectively excludes most individuals with hemochromatosis from donating blood.

FDA has agreed to make the necessary regulatory changes to remove barriers to

donation once financial incentives for hemochromatosis patients are removed.13

There are several different requirements that would need to be changed. FDA currently requires an 8-week interval between donations to prevent iron depletion of

donors, but individuals with hemochromatosis at the initial stage of treatment undergo therapeutic phlebotomies 1 to 2 times a week. FDA also requires blood from

therapeutic bleeding, including for hemochromatosis, to be labeled with the disease

for which the bleeding was performed, which discourages health care providers from

using this blood.

As an initial step, FDA recently agreed to consider case-by-case exemptions to existing regulations on blood labeling and frequency of blood collection for blood establishments that can verify that therapeutic phlebotomy for hemochromatosis is performed at no expense to the patient. However, FDA officials have publicly stated

that in making these exemptions, they will require a commitment from blood collection facilities to concurrently provide safety data, including viral marker rates, incidence of transmissible infections based on seroconversion rates, frequency of

postdonation reports of undisclosed risks, and reports of adverse events.

Individuals with hemochromatosis have the potential to make up some of the loss

in blood donations due to the U.K. donor exclusion policy. Estimates of increases in

the blood supply through donations by these individuals vary widely, from 300,000

to 3 million units—although the former is generally considered a better estimation.

Regardless, changes to current regulations affecting blood from hemochromatosis

patients will occur considerably later than FDA guidance to exclude donors, which

has already gone into effect. It seems unlikely that the issue of coverage of therapeutic phlebotomies by insurers will be quickly addressed and that anything less

than full reimbursement may be considered undue donor incentive. Therefore, unless blood centers absorb the costs of providing therapeutic phlebotomies to persons

with hemochromatosis, it is also unlikely that FDA will revise current regulations.

CONCLUSIONS

On the basis of the information we reviewed, we conclude that the blood supply

is not in crisis. However, there is cause for concern about the possibility of some

regional shortages and shortages of some types of blood. These may be exacerbated

somewhat by the U.K. donor exclusion policy, which will affect blood banks difVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00019 Fmt 6633 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
17

ferently. Potential additions to the blood supply from hemochromatosis patients cannot occur for some time, since blood from these individuals will not be entered into

the community supply until issues related to who pays the costs of therapeutic

phlebotomies are resolved and regulatory changes are implemented.

This concludes my prepared statement, Mr. Chairman. I will be happy to respond

to any questions that you or Members of the Subcommittee may have.

CONTACTS AND ACKNOWLEDGMENTS

For future contacts regarding this testimony, please call Janet Heinrich at (202)

512-7119. Key contributors to this testimony include Marcia Crosse, Martin T.

Gahart, and Angela Choy.

Mr. UPTON. Thank you very much.

Mr. Roslewicz.

TESTIMONY OF THOMAS D. ROSLEWICZ

Mr. ROSLEWICZ. Thank you, Mr. Chairman.

If I may, I would like to invite Mr. Joseph Green to join me at

the table. He is the Assistant Inspector General for Audits at our

Public Health Service Audit Division.

Mr. UPTON. That would be fine. I need to swear him in as well.

I should have.

Mr. ROSLEWICZ. His staff was responsible for this audit.

[Witness sworn.]

Mr. ROSLEWICZ. Thank you, Mr. Chairman.

Mr. UPTON. Thank you.

Mr. ROSLEWICZ. I’m pleased to discuss the results of our work requested by the subcommittee concerning the Food and Drug Administration’s error and accident reporting process for blood.

Errors and accidents are events occurring in blood establishments that may affect the safety, security or potency of blood and

blood products. Examples include incorrectly labeling blood products or shipping the unit that has repeatedly tested reactive to a

viral marker test, such as human immuno deficiency, HIV virus.

According to FDA, it is important that the agency receive error

and accident reports from blood establishments so that it can accurately monitor actions taken to respond to problems and facilitate

a rapid response where the public health may be at risk. We issued

a final report on May 31, 1995, detailing our findings and recommendations to the Commissioner of Food and Drugs.

At that time, FDA agreed to take specific regulatory steps to

strengthen its oversight of the blood industry. As I discussed below,

the agency proposed regulations in 1997 to improve the error and

accident reporting process but does not anticipate issuing the final

regulations until February 2001.

The FDA is the Federal agency responsible for regulating blood

establishments, which include human blood and plasma donor centers, blood banks, transfusion services, and other blood product

manufacturers. Such regulation, which is the responsibility of the

Center for Biologics, Evaluation and Research—CBER—includes

registering establishments, licensing products and issuing and enforcing safety rules. The Office of Regulatory Affairs directs the

agency’s field staff, which performs inspections of blood establishments, to ensure, for example, that they are complying with current manufacturing practices and implementing all the safeguards

over blood and blood products.

18

In the early 1990’s, we chose to review FDA’s error and accident

reporting process because it was critical to FDA’s oversight of the

blood industry. Further, the agency planned to expand the use of

the error and accident reports to upgrade the quality of the blood

industry.

Licensed blood establishments, those that ship their products

interstate, are required by regulation to promptly report errors and

accidents to FDA. Unlicensed establishments, those operating

intrastate, have been requested by FDA to voluntarily submit reports. When errors and accidents occur, all blood establishments

are required to investigate them, take appropriate corrective action

and, if indicated, initiate a recall. The Food and Drug Administration uses the error and accident reports to gauge the severity of the

incident, monitor the actions taken in response to the events reported, and to classify the most serious events as recalls.

In fiscal year 1998, FDA received about 13,000 error and accident reports. Our reviews show that FDA’s error and accident reporting process is a valuable management tool because it provides

a framework to enable the agency to evaluate and monitor the

blood establishments’ actions to problems. However, the process

would require more prompt and comprehensive reporting to be able

to provide an effective early warning device for FDA field offices

and the blood industry.

We found two shortcomings that could hamper FDA’s plan to expand the usefulness of error and accident reports. First, the blood

establishments were not submitting error and accident reports to

FDA promptly, as required by Federal regulations. Our sample indicates that the time between the date the error or accident was

detected and the date it was reported to FDA ranged from less

than 1 month to over 1 year, with an average of a little over 4

months. Only about 14 percent of the error and accident reports we

reviewed were submitted by blood establishments within 1 month

after the detection of the incident, while 13 percent were reported

6 months or more after detection.

Second, there was no assurance that unlicensed blood establishments were voluntarily submitting their reports. At the time of our

review, even though 75 percent of the 2,900 blood establishments

were involved in intrastate activity only, and thus were unlicensed,

this group provided only 1 percent of the error and accident reports

received by FDA.

Overall, we concluded that, without prompt and complete reporting by blood establishments on the number and types of errors and

accidents that are detected, FDA may be hampered in its efforts to

evaluate and monitor the blood industry.

In May 1995, we recommended that the Commissioner of Food

and Drugs, first of all, expedite the development and issuance of

revisions to the Federal regulation on error and accident reporting

to be more specific concerning the timeframe in which error and accident reports are required to be submitted and, second, expedite

the development and issuance of a regulation to require unlicensed

blood establishments to submit error and accident reports.

The FDA agreed with these recommendations and assured us

that they were already taking action to implement them. The agenVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00021 Fmt 6633 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
19

cy estimated that the proposed regulations would be issued in November 1995. I’m just about finished.

Mr. UPTON. That’s fine.

Mr. ROSLEWICZ. In August 1999, staff of the subcommittee requested the Office of Inspector General to determine the status of

our 1995 recommendations. Through an August 24, 1999, memorandum, FDA provided the following information: A proposed rule

was published on September 23, 1997, first of all, to require blood

establishments to report errors and accidents as soon as possible

but not to exceed 45 calendar days; and, second, required reporting

of all blood establishments, including licensed manufacturers of

blood and blood components, unlicensed registered blood establishments and transfusion services.

CBER was in the process of making revisions to the proposed

rule based on the comments received during the comment period.

In an effort to make reporting requirements effective and less burdensome to the industry, the FDA planned not issuing the final

regulation until—they delayed until February 2001 because of multiple public-health-related priorities of the agency.

We recently spoke with FDA officials involved in blood safety to

pinpoint reasons for the delay in issuing the final regulation. According to the Director of CBER, the Food and Drug Administration received 97 comments on the proposed rule. The comments

were varied and complex and required revision of considerable solutions in order to give a straightforward response. The Director

stated that the final regulations were slated to be cleared through

FDA by June 2000 and that they would likely be published in February 2001.

Mr. Chairman, that concludes my statement. I will be available

to answer questions.

[The prepared statement of Thomas D. Roslewicz follows:]

PREPARED STATEMENT OF THOMAS D. ROSLEWICZ, DEPUTY INSPECTOR GENERAL FOR

AUDIT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES

INTRODUCTION

Mr. Chairman and members of the Subcommittee, I am Thomas D. Roslewicz,

Deputy Inspector General for Audit Services at the Department of Health and

Human Services. I am pleased to discuss our previous work concerning the Food

and Drug Administration’s (FDA) error and accident reporting process for blood. We

issued a final report on May 31, 1995 detailing our findings and recommendations

to the Commissioner of Food and Drugs. At that time, FDA agreed to take specific

regulatory steps to strengthen its oversight of the blood supply. As I discuss below,

the agency proposed regulations in 1997 to improve the error and accident reporting

process, but does not anticipate issuing the final regulations until 2001.

For this hearing, the Subcommittee asked us to summarize the findings and recommendations contained in our 1995 report on the error and accident reporting

process, and to discuss the status of FDA’s actions with regard to our recommendations. Before providing this information, I will briefly describe the FDA’s and the

blood establishments’ responsibilities in ensuring the safety of our blood supply, including a description of the error and accident reporting process.

BACKGROUND

Organizational and Legal Responsibilities

The FDA regulates the blood industry by licensing products, and issuing and enforcing safety rules. The Center for Biologics Evaluation and Research (CBER) is

the FDA component responsible for regulating products used for the prevention,

treatment or cure of diseases and injuries, including blood products, vaccines, seVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00022 Fmt 6633 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
20

rums, and toxins. The Office of Regulatory Affairs (ORA) directs the agency’s field

force, which performs inspections of FDA-regulated establishments.

The PHS Act (Title 42 U.S.C. 262) and the Federal Food, Drug and Cosmetic Act

(Title 21 U.S.C. 331) place the responsibility for the oversight of blood establishments with FDA. The FDA has the authority to register all blood establishments

and to license those establishments that ship blood and blood products interstate.

Registered blood establishments that are not licensed by FDA (these unlicensed establishments do not engage in interstate shipments of blood products) fall under

State licensing procedures. All registered blood establishments—whether licensed or

not—are to be inspected by FDA every 2 years, and many are inspected more frequently if they are under scrutiny for previous quality problems. The FDA has several regulatory options available to it, ranging from warning letters to product seizures, for protecting the blood supply. These enforcement options apply to all registered blood establishments.

The Blood Establishments’ Role in Ensuring Blood Safety

With the emergence of the Acquired Immune Deficiency Syndrome (AIDS) epidemic, ensuring the safety of the blood supply has become extremely complex. While

FDA provides guidance to blood establishments to help them comply with industry

standards and safeguards, all blood establishments, including unlicensed establishments, are responsible for ensuring the safety of their blood products. To meet this

responsibility, blood establishments are to comply with established current good

manufacturing practices, which are defined as those standards that would be generally acceptable in a particular industry and would result in the manufacturing of

products which would meet standards of the Federal Food, Drug and Cosmetic Act.

They are also required to fully implement all safeguards over blood and blood products including:

• eliminating high risk donors by encouraging them to exclude themselves, and by

evaluating their behavioral and medical history as a basis for deferral;

• updating a list of unsuitable donors and checking the donors’ names against this

list to prevent use of their blood;

• testing the blood for such blood-borne agents as HIV, hepatitis, and syphilis;

• quarantining all donated blood until tests and other control procedures established its safety; and

• investigating all incidents, auditing their systems, and correcting all deficiencies.

When an error or accident occurs that may affect the safety, purity, or potency

of blood, licensed blood establishments are required to self-report the incident to

FDA. Unlicensed establishments are not required to self-report, but have been requested to do so on a voluntary basis. The FDA has provided guidance to the blood

establishments as to what constitutes a reportable error or accident. The reportable

incidents include, but are not limited to, the following:

• release of units repeatedly reactive to tests indicating hepatitis or HIV;

• release of units in which testing was performed incorrectly or misinterpreted;

• release of units from donors who are, or should have been, permanently or temporarily deferred due to medical history or a history of repeatedly reactive viral

test results for hepatitis or HIV;

• release of units prior to completion of all tests or that are incorrectly labeled, e.g.,

incorrect expiration date; and

• release of contaminated blood components when the contamination is attributed

to an error in manufacturing.

The error and accident report identifies the blood establishment, the donor, the

blood product, and the final disposition of the blood product. It contains appropriate

dates such as date the incident occurred, date it was discovered, date of the report,

and type of error or accident involved. There are three basic types of incidents: (1)

labeling error or accident—testing correctly performed, but incorrect label applied

to product; (2) testing error or accident—test either incorrectly performed or misinterpreted, or product released inadvertently before tests completed; and (3) manufacturing/control procedure error or accident. The report also lists contributing factors causing the error or accident and the actions taken by the blood establishment.

FDA’s Role in Processing Error and Accident Reports

The FDA relies on error and accident reports, in conjunction with inspections and

other surveillance activities, to provide a continuing overview of the blood industry.

According to FDA, receipt of the reports—which numbered 13,232 in Fiscal Year

1998—helps ensure that the industry identifies instances where additional corrective action is needed, such as additional training and revisions of standard operating procedures.

21

1 Regulation 21 CFR 600.14(a) states that error and accident reports are to be submitted to

CBER promptly, but does not define the term ‘‘promptly’’.

The error and accident reports are to be submitted ‘‘promptly’’ 1 to CBER’s Office

of Compliance, which is responsible for analyzing the reports. If the report clearly

does not require further evaluation of the severity of the incident, it is sent to the

appropriate district office for follow up at the next inspection. The FDA’s ORA is

responsible for the coordination of all field office activities. The field offices, under

the direction of ORA, are responsible for conducting all routine blood establishment

inspections.

If an error and accident report indicates that further evaluation of the severity

of the incident is warranted, the report is forwarded to Case Management within

the Office of Compliance. This group evaluates the error or accident being reported

and, based on the severity of the incident, may recommend that it be classified as

a blood recall. At the time of our previous review, about 8 percent of the error and

accident reports were referred to Case Management to be evaluated for a recall classification.

A recall is a blood establishment’s voluntary removal or correction of a marketed

blood product that violates laws administered by FDA. The FDA cannot issue a

product recall but can request that a firm do so. The FDA recognizes that a voluntary recall is generally more appropriate and affords better protection for consumers than seizure, which is a FDA option when a firm refuses to undertake a

recall. In the case of blood, blood establishments are responsible for voluntarily initiating recalls to protect the public health from any defective products. They are also

responsible for developing a recall strategy and determining whether the recall is

progressing satisfactorily. Blood recalls differ from other product recalls because

blood, having a short shelf life, is often used before it can be retrieved. If the blood

cannot be retrieved, the blood establishment is responsible for identifying all recipients of the blood subject to the recall so that they can take extra steps to guard

their health and avoid infecting others.

The FDA is responsible for classifying the blood establishment’s recall according

to the health hazard presented by the incident, and conducting its own audit checks

to assess whether the establishment has notified all affected parties and taken appropriate action. The FDA publishes all recall actions in its weekly Enforcement Report regardless of when the recall was made.

According to FDA, since blood establishments are required to investigate all errors and accidents, including those that are eventually classified as blood recalls,

the corrective action is generally completed by the blood establishment before FDA

classifies the recall. At the time of our review, FDA told us that compliance with

industry standards and safeguards accounted for the relatively few accidents severe

enough to warrant a blood recall.

FDA’s 1993 Plan For Blood Quality Assurance

Just prior to our review of 1993-1994 error and accident reporting, FDA proposed

a plan to establish a blood quality assurance initiative aimed at ensuring the safety

of the Nation’s blood supply and upgrading the operational quality of the blood industry. As part of the plan, FDA sought to: strengthen its capability to identify

blood center operational deficiencies; provide appropriate guidance to the blood industry; educate and assist blood centers in conforming to this guidance; provide

more timely decisions on licensing applications and amendments; and carry out inspections that assess the industry’s progress in bringing operations to a higher

standard.

One component of this plan focused on the blood industry’s self-reporting of errors

and accidents that may affect the safety, purity, or potency of blood and blood products. The FDA envisioned that the error and accident reports submitted by blood

establishments could be used to identify trends and develop appropriate ‘‘early

warning’’ guidance to the field offices and the blood industry. Another component

of this plan was the consolidation of FDA’s multiple automated systems into a single

relational data base designed to facilitate the exchange of information between field

and headquarters staff and permit FDA to identify trends and problems in early

stages of development and issue guidance to blood establishments to prevent errors

and accidents.

OIG FINDINGS AND RECOMMENDATIONS ON ERROR AND ACCIDENT REPORT PROCESSING

Our review showed that while FDA’s error and accident reporting process was a

valuable management tool for evaluating and monitoring blood establishments’s actions, it could be more useful with prompter and more comprehensive reporting. The

22

FDA processed error and accident reports in our sample in accordance with established procedures; however, we identified two shortcomings that could hamper the

success of FDA’s plan to expand the usefulness of error and accident reports:

(1) Blood establishments were not submitting error and accident reports to FDA

‘‘promptly,’’ as required by the regulation (21 CFR 600.14(a)) and as encouraged by

FDA correspondence with the industry in 1991. Based on a sample of 163 error and

accident reports received in the first half of Fiscal Year 1993, we found that the

time between the date the error or accident was detected and the date it was reported to FDA ranged from less than 1 month to over 1 year, with an average of

a little over 4 months. Only about 14 percent of the error and accident reports we

reviewed were submitted by the blood establishments within 1 month after the detection of the incident, while 13 percent were reported 6 months or more after detection.

We concluded that blood establishments, in light of the lack of specificity concerning the term ‘‘promptly,’’ were taking a liberal interpretation of the time frame

in which they are to report incidents affecting blood and blood products. This concerned us given that there were 17 cases in our sample requiring further evaluation

for a possible recall. These cases involved, for example, shipping blood that tested

positive for Hepatitis C; shipping mislabeled plasma units; and shipping units of red

blood cells that were contaminated after being stored at room temperature.

(2) There was no assurance that unlicensed blood establishments were voluntarily,

as requested by a March 1991 FDA memorandum, submitting the reports. Data provided by FDA during our review indicated that of the 10,308 error and accident reports submitted to the agency during Fiscal Year 1991, 99 percent were submitted

by licensed blood establishments, with only 148 reports—about 1 percent—submitted by unlicensed blood establishments. We found a similar split between the licensed and unlicensed establishments for the error and accident reports reviewed

in our sample: Of the 163 error and accident reports in our sample, only 2 were

from unlicensed establishments. Acknowledging that FDA was seeking to more effectively evaluate and monitor the blood industry—as outlined in its 1993 plan—

we concluded that it should have reports from the full spectrum of establishments.

Comparing the reporting data with the numbers of unlicensed establishments, we

believed that the statistics provided by FDA and the data from our sample were

more likely indicative of nonreporting, rather than unlicensed establishments having less problems than their licensed counterparts. At the time of our review, about

2,900 blood establishments were registered by FDA: about one-fourth of those registered would have been licensed by FDA, and required to submit error and accident

reports related to blood and blood products. The remaining 75 percent of the registered blood establishments would not be shipping blood or blood products interstate and, therefore, would be unlicensed. Unlicensed establishments are not required to submit these reports to FDA except for cases involving fatalities. According to FDA at the time of our previous review, unlicensed establishments accounted

for about one-tenth of the blood collected in this country.

We concluded during our previous review that without prompt and complete reporting by blood establishments on the number and types of errors and accidents

that are detected, FDA may be hampered in its efforts to evaluate and monitor the

blood industry. The FDA pointed out repeatedly that delays in reporting by licensed

blood establishments and/or failure to voluntarily report by unlicensed establishments should not cause corresponding delays in initiating action aimed at correcting

the specific problems being reported. This is because all blood establishments are

required to investigate and correct all errors and accidents detected, independent of

the reporting process. While we did not evaluate the timeliness or appropriateness

of the blood establishments’ actions, we noted that all 163 error and accident reports

in our sample contained information showing that some action was taken. According

to FDA, the actions reported to be taken by the blood establishments were appropriate.

In May 1995, we recommended that the Commissioner of Food and Drugs:

1. Expedite the development and issuance of revisions to the Federal regulation on

error and accident reporting (21 Code of Federal Regulations (C.F.R.) 600.14(a))

to be more specific concerning the time frame in which error and accident reports are required to be submitted;

2. Expedite the development and issuance of a regulation to require unlicensed

blood establishments to submit error and accident reports; and

3. Expand CBER’s use of existing information in its current error and accident data

base to identify blood establishments that regularly fail to submit error and accident reports in a timely manner and provide additional trend analysis reports

to FDA field offices and blood establishments.

23

In its April 28, 1995 response to our draft audit report, the Public Health Service

(PHS), FDA’s oversight agency at the time of our review, agreed with our recommendations and indicated that FDA was taking action to implement them. The

PHS asked us to revise our recommendations to reflect its view that many ideas

presented in our report were already being translated into action. For example, PHS

asked the OIG to add the word ‘‘expedite’’ to recommendations 1 and 2. The agency

also informed us in its comments that the proposed regulation regarding recommendations 1 and 2 would be issued in November 1995, with a final publishing

date of February 1996.

STATUS OF FDA ACTIONS ON OIG RECOMMENDATIONS

In August 1999, staff of the Subcommittee requested the OIG to contact FDA to

determine the status of the recommendations made in its May 1995 report. In response to our request, FDA’s Deputy Commissioner for Management and Systems

forwarded a written memo, dated August 24, 1999 providing an update on our recommendations.

Regarding our recommendations to expedite development and issuance of revisions to the Federal regulation on error and accident reporting, to be more specific

about the time frame in which the reports are to be submitted, and to require unlicensed establishments to submit such reports, FDA provided the following information:

• A proposed rule was published on September 23, 1997 to: (1) require blood establishments to report errors and accidents ‘‘as soon as possible but not to exceed

45 calendar days,’’ and (2) require the reporting of all blood establishments including licensed manufacturers of blood and blood components, unlicensed registered blood establishments, and transfusion service. The introductory portion

of the proposed rule states: ‘‘FDA regards the proposal to amend the error and

accident reporting regulation to be an essential tool in its directive to protect

public health by establishing and maintaining surveillance programs that provide timely and useful information.’’

• CBER was in the process of making revisions to ‘‘the proposed rule based on the

comments received during the comment period in an effort to make reporting

requirements effective and less burdensome to the industry.’’

• The FDA planned a delay in issuing the final regulation until February 2001 ‘‘because of multiple public health related priorities of the Agency.’’

Regarding our third recommendation, focusing on FDA expanding the use of error

and accident report information, the agency informed us that summary reports of

errors and accidents continue to be sent to FDA’s Office of Regulatory Affairs Regional and District Directors and are also available to the industry through CBER’s

FAX Information system. The FDA further stated that CBER would continue to

identify trends for reporting times, but that it would wait until the final rule is published—in February 2001—before making any changes in how the error and accident information is used.

The agency response provided limited detail on the status of our recommendations; however, in anticipation of this hearing, we recently spoke with FDA officials

involved in the blood safety area to pinpoint reasons for FDA’s anticipated delay in

issuing the final regulation. According to the director of CBER, FDA received 97

comments on the proposed rule—comments that were varied and ‘‘not straightforward’’ to address. She stated that the final regulations were slated to be cleared

through FDA by June 2000 and that they would likely be published in February

2001.

CONCLUSION

That concludes my testimony, Mr. Chairman. At this time, I would be happy to

answer questions from the Subcommittee.

Mr. UPTON. Thank you very much.

Ms. Sullivan.

TESTIMONY OF MARIAN T. SULLIVAN

Ms. SULLIVAN. Good morning. My name is Marian Sullivan. I’m

the Executive Director of the National Blood Data Resource Center

in Bethesda, Maryland. I’m pleased to have the opportunity to

speak to you about the NBDRC; and after briefly introducing you

to our organization and our activities, I will summarize for you our

24

most recent findings regarding the U.S. blood supply and our plan

for monitoring it in the next 16 months.

The NBDRC is an independent, not-for-profit corporation, conceived and founded by the American Association of Blood Banks in

July 1997. The mission of the NBDRC is to collect, analyze and distribute data on all aspects of blood banking and transfusion medicine. Prior to the founding of the NBDRC, there was no existing

organization dedicated to the collection of blood supply monitoring

data.

The goals of the NBDRC are to assist members of the blood community in identifying and assessing existing and emerging issues,

improving operations, promoting the highest standards of care for

patients and donors, and making policy at the national, regional

and local levels. In short, we strive to provide whatever information is needed by the community to ensure a safe and efficient

blood system.

We rely on the AABB and our own limited membership for the

financial support of our operations. Our small staff has worked

hard to meet our goals in the brief 25 months since we opened our

doors. Our accomplishments include the 1998 Nationwide Blood

Collection and Utilization Survey, a comprehensive survey of blood

services activities completed by 2,360 blood centers and hospitals.

Data from this project have assisted numerous Federal agencies

and advisory committees in recent policy discussions and been

quoted in the media by the Surgeon General, yet not $1 of Federal

funds supported this ambitious NBDRC project.

The NBDRC has also contributed directly to the safety of the

blood supply by continuation of the long-term Creutzfeldt-Jakob

Disease Lookback Study, now funded by the Centers for Disease

Control and Prevention, and the Survey of Donation Incentives,

supported by a grant from the National Blood Foundation.

The results of our most recent national survey indicated that

700,000 fewer units of whole blood were collected in the U.S. in

1997 than in 1994, a statistically significant decrease of 5.5 percent. It’s important to note that 205,000 of these units were directed donations intended for a specific patient and 643,000 units

were autologous donations for the donor’s own use. Although we

recognize that both directed and autologous donations have been on

a steep downward trend since they peaked in popularity in 1992,

we cannot disregard the fact that these donations combined to account for .6 million transfused units in 1997, units that would have

otherwise come out of the community supply.

On the other hand, the total number of transfused whole blood

and red cell units increased by 4 percent in 1997, in comparison

with 1994, to 11.45 units. If the rates of overall blood collection and

transfusion that occurred between 1994 and 1997 are continuing,

the United States may experience a national blood shortage as

early as next year.

The NBDRC is committed to conducting another nationwide survey in 2000, even if it must be supported entirely by internal funds

and report sales as it was last year. The results of the 2000 survey,

which will be available to NBDRC members and customers approximately 12 months from now, will provide data for 1999 and

enable us to extend the historical trends analysis.

25

However, in the interim between surveys, there’s little information available regarding the adequacy of the blood supply, other

than anecdotal. Some blood centers have recently reported significant increases in collections, while other centers issue repeated appeals for blood. The impact of this on the national supply cannot

be carefully assessed without current nationwide data for comparable time periods and donation types.

In order to better estimate the adequacy of the recent supply and

to enable us to more accurately project the available supply for

next year, the NBDRC is currently conducting a QuiKount of the

whole blood donations made at every U.S. blood center. The survey

will capture blood collection data for all of 1998 and the first 6

months of 1999 by calendar quarter. This project is supported entirely by internal funding, and the results will be shared with all

interested parties in early November.

Finally, I’m very pleased to tell you that we will begin to collect

supply data on a monthly basis in approximately 2 months from a

representative sample of blood centers under a short-term financial

arrangement with the National Heart, Lung and Blood Institute.

Congress has rightly recognized that the safety of our blood supply is a national public health priority. However, patients cannot

benefit from safe blood if it is not readily accessible, and long-term

blood collection and usage data are needed to detect and avoid potential blood shortages.

The NBDRC urges Congress to support the collection of blood

supply monitoring data. We are proud that in our short tenure the

NBDRC has established a reputation as the premier source of national blood data. We appreciate the recognition of this subcommittee, the NHLBI and the various advisory committees and

agencies which relied on our data to characterize the U.S. blood

supply. You have our commitment to continue to provide accurate

and timely data to meet the needs of the U.S. public health service

as long as sufficient financial support is available.

Thank you for the opportunity to testify today. I will be pleased

to answer any questions.

[The prepared statement of Marian T. Sullivan follows:]

PREPARED STATEMENT OF MARIAN SULLIVAN, EXECUTIVE DIRECTOR. NATIONAL

BLOOD DATA RESOURCE CENTER

Good morning, My name is Marian Sullivan. I am the Executive Director of the

National Blood Data Resource Center (NBDRC) in Bethesda, Maryland. I am

pleased to have the opportunity to speak to you about the NBDRC. After briefly introducing you to the NBDRC and our activities, I would like to outline for you our

most recent findings regarding the U.S. blood supply and our plan for monitoring

it in the next sixteen months.

The NBDRC is an independent, not-for-profit, corporation, conceived and founded

by the American Association of Blood Banks (AABB) in July of 1997. The mission

of the NBDRC is to collect, analyze, and distribute data on all aspects of blood banking and transfusion medicine. Prior to the founding of the NBDRC, there was no

existing organization dedicated to the collection of blood supply monitoring data.

The goals of the NBDRC are to assist members of the blood community at large

in identifying and assessing existing and emerging issues, validating new technologies, improving operations, promoting the highest standards of care for patients

and donors, and making policy at the national, regional, and local levels. In short,

we strive to provide whatever information is needed by the community to ensure

a safe and efficient modern blood system.

We rely on the AABB and our own limited membership for the financial support

of our operations. Our small staff has worked hard to meet our goals in the brief

26

25 months since we opened our doors. Our accomplishments include the 1998 Nationwide Blood Collection and Utilization Survey—a comprehensive survey of blood

services activities completed by 2,360 blood centers and hospitals. Data from this

project have assisted numerous federal agencies and advisory committees in recent

policy discussions, and been quoted in the media by the Surgeon General, yet not

one dollar of federal funds supported this ambitious NBDRC project.

The NBDRC has also contributed directly to the safety of the blood supply by continuation of the long-term Creutzfeldt-Jakob Disease Lookback Study, now funded

by the Centers for Disease Control and Prevention, and the Survey of Donation Incentives, supported by a grant from the National Blood Foundation.

The results of our previous Nationwide Blood Collection and Utilization Survey

indicated that 700,000 fewer units of whole blood were collected in the United

States in 1997 than in 1994, a statistically significant decrease of 5.5%. It is important to note that 205,000 of these units were directed donations (intended for a specific patient) and 643,000 units were autologous donations (for the donor’s own use).

Although we recognize that both directed and autologous donations have been on

a steep downward trend since they peaked in popularity in 1992, we cannot disregard the fact that these donations combined to account for 0.6 million transfused

units; units which would have otherwise come out of the community supply.

On the other hand, the total number of transfused whole blood and red blood cell

units increased by 4% in 1997 in comparison to 1994, to 11.5 million units. If the

rates of overall whole blood collection and transfusion that occurred between 1994

and 1997 are continuing, the United States may experience a national blood shortage as early as next year.

The NBDRC is committed to conducting another Nationwide Blood Collection and

Utilization Survey in 2000, even if it must be supported entirely by internal funds

and report sales, as it was last year. The previous survey captured blood collection

and transfusion data for the calendar year 1997. In February 2000 we will distribute the next nationwide survey to 3,000 hospitals and blood centers.

The results of the 2000 survey, which will be available to NBDRC members and

customers approximately twelve months from now, will provide data for 1999, and

enable us to extend the historical trends analysis through 1999 as well. However,

in the interim between surveys, there is little information available regarding the

adequacy of the blood supply, other than anecdotal. Some blood centers have recently reported significant increases in 1998 and 1999 collections, while other centers have issued repeated appeals for blood, beginning well in advance of the anticipated summer shortages this year. The impact of this on the national supply cannot

be carefully assessed without current nationwide data for comparable time periods

and donation types.

In order to better estimate the adequacy of the recent supply, and to enable us

to more accurately project the available supply for the year 2000, the NBDRC is currently conducting a ‘‘QuiKount’’ of the whole blood donations made at every U.S.

blood center. The short survey was mailed out last week and will capture blood collection data for all of 1998 and the first six months of 1999 by calendar quarter.

The QuiKount project is supported entirely by internal funding, and the results will

be shared with all interested parties in early November.

Finally, I am very pleased to tell you that we will begin to collect supply data

on a monthly basis in approximately two months, under a short-term financial arrangement with the National Heart, Lung and Blood Institute (NHLBI). Initially,

we will enlist the participation of a representative sample of blood centers willing

to report their monthly distribution figures very rapidly. Later on, next year, we

hope to bring the corresponding national hospital sample on-line in order to capture

timely and detailed blood utilization data.

Congress has rightly recognized that the safety of our blood supply is a national

public health priority. However, patients cannot benefit from safe blood if it is not

readily accessible. Moreover, long-term blood collection and usage data are needed

in order to detect and avoid potential blood shortages. The NBDRC urges Congress

to support the collection of blood supply monitoring data.

We are proud that in our short tenure, the National Blood Data Resource Center

has established a reputation as the premier source of reliable, national blood data,

and we sincerely appreciate the recognition of this subcommittee, the NHLBI, and

the various advisory committees, task groups and agencies which have relied on our

data to characterize the U.S. blood supply. You have our commitment to continue

to provide accurate and timely data to meet the needs of the U.S. Public Health

Service, both routine and urgent, as long as sufficient financial support is available.

Thank you for the opportunity to testify today. I would be pleased to answer any

questions.

27

Mr. UPTON. Thank you.

Dr. AuBuchon.

TESTIMONY OF JAMES P. AUBUCHON

Mr. AUBUCHON. Good morning. My name is James AuBuchon.

I’m a physician and professor of pathology and medicine at Dartmouth Medical School and Medical Director of the Blood Bank and

Transfusion Service of Mary Hitchcock Memorial Hospital in New

Hampshire. I appreciate the opportunity to offer the perspective of

a physician who specializes in transfusion medicine in considering

blood safety and availability.

Transfusion medicine specialists are pleased, and I’m sure our

patients are grateful, that receiving a transfusion today has less

risk than ever before. Reduction in the risk of viral transmission

has occurred through the diligence of oversight on the part of regulatory bodies such as the FDA and through the dedication of thousands of medical, technical and administrative professionals in

blood centers and hospitals.

The success of these efforts has created new dilemmas, however.

Dramatic reductions in the risk of HIV have fueled public anticipation of transfusion without any risk. However, continual focus on

one type of risk, viral infection, prevents a rational prioritization

according to where the greatest residual risk remains. Reducing

the risks of transfusion also encourages transfusion in situations

where the predictable benefit is smaller.

The consequential increase in demand for blood comes at a time

when the demands for increased safety and other factors have reduced the availability of blood. The intersecting interests here are

clear particularly when an inadequate blood supply becomes a safety risk for a patient who cannot get a needed transfusion.

It is commonly accepted among transfusion medicine specialists

that many transfusions cannot be justified medically. For example,

at least a third of plasma transfusions do not occur in situations

where the plasma confers benefit. We face three major hurdles in

reducing inappropriate transfusion.

One, information. We simply do not have enough data about the

effects of transfusing all the different kinds of blood components

and all the different kinds of clinical situations where they may be

applied. As a result, many transfusion decisions are made on

guesses and personal experience. Studies indicate that a conservative approach to transfusion uses less blood in the end and is associated with better patient survival. Clearly, more clinical research is needed to define when transfusion should not be given.

Two, patient variability. Compounding the problem of inadequate

research in this field is the inherent variability of patients. What

may be a safe level of anemia that does not require treatment for

one may be lethal for another. Medical science does not allow us

to know enough about each patient to make well-founded individual decisions. The consequences of not transfusing when needed

are immediate and catastrophic, whereas the consequences of

transfusing when not needed are distant and only remote possibilities; hence, physicians frequently err on the side of treatment.

Three, education. In attempting to change transfusion behaviors,

considerable trust must be developed in the transfusion medicine

28

specialist by the clinician. This must be followed by the investment

of considerable time for prompt clinical interactions to redirect the

clinician’s practice. Many studies have shown that ongoing interactions with clinicians can have a positive impact. However, there

is no support for this activity; and only academic medical centers

have the trained staff and anything close to sufficient time to attempt it.

Given the demographics of our population, the blood supply situation is only going to get worse. A report of the Office of Technology Assessment 15 years ago noted that while 12 percent of the

population was age 65 or over, this segment accounted for 22 percent of all hospital admissions and 45 percent of all transfusions.

The graying of the population will not only accelerate blood usage

but also reduce the number of available donors.

We may already be seeing the tip of the iceberg of this shortage.

Will the periodic shortages we have been experiencing with increasing frequency become perpetual? Will the trends of increasing

usage and decreasing availability soon combine to cause the death

of a patient needing a transfusion? What can we do to forestall

this?

Frankly, I do not hold out the promise of significant reduction in

usage because of the advancing age of the population and because

of increased aggressiveness of a wide variety of therapies that

would require transfusion support. Greater use of autologous blood

options is attractive but impractical since most approaches to

autologous therapy are more expensive than depending on the community blood supply. Until this blood supply is so short or undependable that elective surgery is frequently postponed, most will

not opt for this approach.

Some blood conservation mechanisms are now fairly common in

larger hospitals, and these do decrease reliance on the community

supply. For example, using equipment to recover red cells lost in

surgical wounds for reinfusion back to the patient can decrease the

transfusion of banked blood by 50 percent or more in cases that require blood. Smaller hospitals find only occasional use for this

equipment, however, and have not adopted it widely.

Other options, such as diluting the patient’s blood with a salt solution while collecting several units at the start of a surgical procedure, generally save a unit of blood or less and are not cost-effective. Units of blood donated by patients several weeks ahead of surgery do save the need to call on the community blood supply as

often. However, not all patients are in sufficiently good health to

donate, and unused units do not augment the blood supply.

Is medical practice likely to change sufficiently to avoid or delay

the projected shortfall in blood availability? Physicians and surgeons have become accustomed to a safe and readily available blood

supply. It is difficult to make the argument to a physician that he

or she should increase the risk of a heart attack in his or her patient in order to maintain the blood bank’s inventory so that another patient might have blood available. Increasing the knowledge

base of clinicians about appropriate transfusions would tend to decrease usage, but this will require concerted effort of the entire

medical establishment, and there are just too few medical specialists in transfusion medicine to accomplish this.

29

What is needed? The medical community will likely acclimate

itself to blood shortages through increased internal audits of blood

transfusion decisions in each hospital. This committee and Congress could provide assistance in a variety of ways. I would make

a plea for funds for research and educational efforts, and I would

ask that when the American Association of Blood Banks comes before Congress each year to define areas in which heightened research activity would be beneficial that Congress accept these recommendations with the knowledge that all in society will benefit

from these advances.

Furthermore, Congress can provide needed assistance to us today

in our mission by serving as the voice of the people, by helping to

define for the blood banking community what society expects from

its blood supply.

When the requirements of increased safety and tightening availability conflict, how should choices be made? The FDA, chastened

by retrospective criticism of decisions made over 15 years ago, always opts for increased safety, regardless of the costs and with

scant attention on supply. Many in our field believe that the public

still expects the impossible, a risk-free blood supply. The public’s

attention to AIDS and hepatitis is focused on minuscule or improbable infectious risks while missing much larger opportunities to

make transfusion safer, such as methods to ensure that units are

transfused to the right patient.

A clear statement of understanding that safety and availability

may have opposing elements and a clear acceptance that a certain

level of risk is unavoidable would help all blood bankers and transfusion specialists deal with the reality of our situation productively.

In the same manner, I believe that Congress should recognize

that blood is indeed different than other medical commodities. Including its provision in underfunded Medicare prospective payment

systems and expecting that the free market will resolve all ills in

the blood supply system is mistaken. Heaping additional safety requirements on the blood supply system by Federal fiat without providing specific financial resources to accomplish these tasks creates

unresolvable conflicts in the blood collection system. In the end,

that constrained system must choose between measures that will

augment safety or that will augment supply, a Hobbsian choice

that none of us wish to make.

I will urge that the important and sacred place that this precious

donated human research has in the medical care system be recognized so that the public’s desire for a safe and adequate blood supply can be met.

Thank you.

[The prepared statement of James P. AuBuchon follows:]

PREPARED STATEMENT OF JAMES P. AUBUCHON, PROFESSOR OF PATHOLOGY AND

MEDICINE, DARTMOUTH-HITCHCOCK MEDICAL CENTER

Good morning. My name is James AuBuchon. I am a physician and a professor

of Pathology and Medicine at Dartmouth Medical School. I am also the Medical Director of the Blood Bank and Transfusion Service of Mary Hitchcock Memorial Hospital in Lebanon, New Hampshire. I appreciate the opportunity to offer the perspective of a physician who specializes in transfusion medicine in considering blood safety and availability.

Those of us in transfusion medicine are pleased—and I am sure that our patients

are grateful—that receiving a transfusion today has less risk than ever before. ReVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00032 Fmt 6633 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
30

duction in the risk of viral transmission has occurred through the diligence of oversight on the part of regulatory bodies, such as the FDA, and through the dedication

of thousands of medical, technical and administrative professionals in blood centers

and hospitals. Early information suggests that when appropriately selected volunteer donors are tested with the most advanced technology, there is virtually no risk

that their donated blood units will transmit the two most feared viruses, HIV and

hepatitis C.

This incredible success story has created new problems for us and for our patients, however. Dramatic reductions in the risk of HIV have fueled public anticipation of transfusion without any risk. However, continual focus on one type of risk—

viral infections—prevents a rational prioritization according to where the greatest

residual risk remains. Reducing the risks of transfusion also encourages transfusion

in situations where the predictable benefit is smaller. The consequential increase in

demand for blood comes at a time when the demands for increased safety and other

factors have reduced the availability of blood. The intersecting interests here are

clear, particularly when an inadequate blood supply becomes a safety risk for a patient who cannot get a needed transfusion.

Transfusion medicine specialists direct much of their consultative efforts into ensuring that transfusions are clinically indicated. Many clinicians view us as the

‘‘blood police’’ because of our attempts to enforce protocols designed to ensure that

this precious, scarce—and potentially dangerous—resource is used wisely. It is commonly accepted amongst our fraternity that many transfusions cannot be justified

medically. For example, several studies of the use of plasma have shown that at

least a third of plasma transfusions do not occur in situations where the plasma

confers benefit, and approximately 10% of red cell transfusions fall into the same

category. We face three major hurdles in reducing these proportions.

1. Information. We simply do not have enough data about the effects of transfusing

all the different kinds of blood components in all the different kinds of clinical

situations in which they may be applied. As a result, many transfusion decisions are made based on guesses, hunches and personal experience. Studies indicate that a conservative approach to transfusion uses less blood in the end,

results in exposure to fewer donors, and is associated with better patient survival. Clearly more clinical research is needed to define when transfusions

should—and need not—be given.

2. Patient Variability. Compounding the problem of inadequate research in this field

is the inherent variability of patients. Not only are babies different from octogenarians, but not every 80 year old man is the same. What may be a safe level

of anemia that does not require treatment for one may be a lethal anemia for

another. Medical science does not allow us to know enough about each patient

to make well-founded individual decisions. The consequences of not transfusing

when needed are immediate and catastrophic, whereas the consequences of

transfusing when not needed are distant and only ‘‘remote possibilities’’; hence,

physicians frequently err on the side of treatment. Indeed, there are concerns

that, in some circumstances, physicians are undertransfusing, that is, withholding transfusion when it would be beneficial, because of overstated fears

about infectious transmission. We must be careful to strike an informed balance

between risk and benefit.

3. Education. In attempting to change transfusion behaviors, considerable trust

must be developed in the transfusion medicine specialist by the clinician; this

must be followed by the investment of considerable time for prompt clinical

interactions to re-direct the clinician’s practice. Many studies have shown that

ongoing interactions with clinicans can have a positive impact. However, there

is no support for this activity, and only academic medical centers have the

trained staff and anything close to sufficient time to attempt this effort. The

monetary savings to the institution for reducing component usage will probably

not justify the many hours of physician time required. The benefits of clinical

consultation that my transfusion medicine colleagues and I can offer patients

are just not available in most hospitals.

Given the demographics of our population, the blood supply situation is only going

to get worse. A study by the Office of Technology Assessment 15 years ago noted

that while 12% of the population was age 65 or over, this segment accounted for

22% of all hospital admissions and 45% of all transfusions. The ‘‘graying of the population’’ will not only accelerate blood usage but also reduce the number of available

donors. Fifteen years ago, there were 8 qualified potential donors for every potential

recipient. In ten years, it is estimated that this ratio will have dropped to 3:1, expanding the difficulties in recruiting enough blood donors.

We may already be seeing the tip of this iceberg with the recent data developed

by the National Blood Data Resource Center, presented today by Marian Sullivan.

31

Will the periodic shortages we have been experiencing with increasing frequency become perpetual? Will the trends of increasing usage and decreasing availability soon

combine to cause the death of a patient needing transfusion? What can we do to

forestall this?

Others will be speaking on efforts to increase blood recruitment success. As one

who formerly directed a blood center, I will only offer the comment that recruitment

efforts take place in the societal milieu. Clearly, societal attitudes about public service and volunteering have changed over the last several decades, and these changes

place additional challenges before donor recruiters. The increasing workweek and

the pressures for efficiency stemming from global competition make availability of

donors at the workplace more difficult as well. Unfortunately, these challenges must

be faced with decreased resources as blood collecting agencies are deferring more

donors than ever before and spending greater proportions of their resources on testing—all at a time when hospitals are demanding reduced costs because of their financial pressures.

What can be done to reduce blood usage? Frankly, I do not hold out the promise

of significant reduction in usage because of the advancing age of the population and

because of increased aggressiveness of a wide variety of therapies that require

transfusion support. Greater use of autologous blood options is attractive but impractical in the current environment. Most approaches to autologous therapy are

more expensive than depending on the (very safe) community blood supply. Until

this blood supply is so short or undependable that elective surgery is frequently

postponed, most will not opt for this approach. Furthermore, since an increasing

proportion of patients are treated under some type of fixed payment system, hospitals have a strong financial incentive not to use more-expensive approaches. Indeed, the shortage may have to reach critical proportions before these alternatives

are widely used. It is unlikely that one hospital would invest in a more-expensive

but blood-conserving approach in order to increase the community’s blood supply to

be shared amongst hospitals that have maintained a less-expensive system.

Some blood conservation mechanisms are now fairly common in larger hospitals,

and these do decrease reliance on the community supply of blood. For example,

using equipment to recover red cells lost in surgical wounds for reinfusion back to

the patient can decrease the transfusion of banked blood by 50% or more in cases

that often require blood, such as cardiac, vascular and orthopedic surgeries. If the

patient requires more than about two units of blood, this option may actually save

money. Smaller hospitals find only occasional use for this equipment, however, and

have not adopted it as widely. Other options, such as diluting the patient’s blood

with a salt solution while collecting several units at the start of a surgical procedure, generally save a unit of blood or less and are not cost-effective. The future

advent of oxygen-carrying solutions will allow collection of more blood while keeping

the patient’s oxygen carrying capacity at a safe level, but the expected high cost of

these solutions will not make their widespread use feasible in the current financial

climate; even in cases with large blood losses, the savings to the community blood

supply are very modest. Units of blood donated by patients several weeks ahead of

surgery do save the need to call on the community blood supply as often. However,

not all patients are in sufficiently good health to donate; unused units do not augment the blood supply since most patients either do not qualify as community blood

donors or their units were collected sufficiently far enough ahead of surgery that

little time remains after surgery to use them for another patient.

Is medical practice likely to change sufficiently to avoid or delay the projected

shortfall in blood availability? Physicians and surgeons have become accustomed to

a safe and readily available blood supply, and new surgical techniques or

chemotherapies are not sidelined because of a projected increased need for blood

support. Certainly, more appropriate usage would reduce the demand a significant

degree. However, it is difficult to make the argument to a physician that he or she

should increase the risk of a heart attack or other bad outcome in his or her patient

in order to maintain the blood bank’s inventory so that another (unnamed, unknown) patient might have blood available. Increasing the knowledge base of clinicians about appropriate transfusion therapy would tend to decrease usage, but this

will require concerted effort of the entire medical establishment. There are too few

transfusion medicine specialists, concentrated primarily in academic medical centers, and there are too few resources to make a broad impact on medical practice

in the short run.

What is needed? The medical community will likely acclimatize itself to blood

shortages through increased internal audits of blood transfusion decisions in each

hospital and educational efforts to reduce the demand for blood. This Committee

and Congress could provide assistance in a variety of ways. I would make a plea

for funds for research and educational efforts, and I would ask that when the AmerVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00034 Fmt 6633 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
32

ican Association of Blood Banks comes before Congress each year to define areas

in which heightened research activity would be beneficial that Congress accept these

recommendations with the knowledge that all in society will benefit from these advances. Furthermore, Congress can provide needed assistance to us today in our

mission by serving as the voice of the people, by helping to define for the blood

banking community what society expects from its blood supply. We in the field will

continue to strive for increased safety and improved availability regardless of the

outcome of this Committee’s deliberations. However, when the requirements of increased safety and tightening availability conflict, how should choices be made? The

FDA, chastened by retrospective criticism of decisions made over 15 years ago, always opts for increased safety—regardless of the cost and with scant attention to

the effect on supply. Recent decisions regarding the potential for transmission of

spongiform encephalopathies through transfusion are an example of this. Many in

our field believe the public still expects the impossible, a risk-free blood supply. The

public’s attention to AIDS and hepatitis has focused us on minuscule or improbable

infectious disease risks while missing much larger opportunities to make transfusion safer, such as methods to ensure that units are transfused to the right patient. A clear statement of understanding that safety and availability may have opposing elements and a clear acceptance that a certain level of risk is unavoidable

would help all blood bankers and transfusion medicine specialists deal with the realities of our situation more productively.

In the same manner, I believe that Congress should recognize that blood is indeed

different than other medical commodities. Including its provision in underfunded

Medicare prospective payment systems and expecting that the free market will resolve all ills in the blood supply system is mistaken. Heaping additional safety requirements on the blood supply system by federal fiat without providing specific financial resources to accomplish these tasks creates unresolvable conflicts in the

blood collection system. In the end, that constrained system must choose between

measures that will augment safety or that will augment supply, a Hobbsian choice

that none of us wish to make. I would urge that the important and sacred place

that this precious, donated human resource has in the medical care system be recognized so that the public’s desire for a safe and adequate blood supply can be met.

Thank you.

Mr. UPTON. Thank you very much.

Mr. Cox.

Mr. COX. Thank you very much.

In particular, Dr. AuBuchon, your testimony has left us with a

strong focus on concerns that we have about the safety of transfusions themselves and about receiving blood. But, just for openers,

I want to make sure I have everybody’s agreement that, in the

United States today, the act of giving blood does not present risks

to the donor. That is an exceptionally safe thing for every American

to do; isn’t that right?

Mr. AUBUCHON. That’s absolutely correct. There is no way that

the donor can get any infectious disease from the donation process.

They will get coffee and cookies, but that’s all they will get.

Mr. COX. While we are at it, because this is an open and most

public hearing that the American people will pay some attention to,

how often can one donate blood safely?

Mr. AUBUCHON. FDA regulations require donation no more frequently than once every 56 days or 8 weeks. That’s based on the

need for the donor to replenish their red cell supply. Other kinds

of donations such as platelets or plasma can be given on a more

frequent basis.

Mr. COX. You could, if you wanted to be especially public-spirited, donate blood 4 or 5 times a year completely safely.

Mr. AUBUCHON. Indeed, you could donate theoretically up to 6

times a year. Unfortunately, most American donors donate, however, once or, at most, twice a year. There are a few committed

ones who donate at least a gallon each year, but most do not.

33

Mr. COX. Before I leave this topic, because I just want to make

sure that everyone understands our object here is to encourage people to donate blood so that we can increase the blood supply and

avoid the problems that Ms. Sullivan is warning about, a possible

blood shortage for the whole country, what percentage of the eligible American population is it our best guess currently donates

blood on a regular basis, at least once a year?

Ms. HEINRICH. The best information that we have is that 5 percent of the eligible population is giving once a year.

Mr. COX. So it’s even worse than voting?

Ms. HEINRICH. Yes.

Mr. COX. By a lot. And 95 percent of eligible Americans aren’t

yet doing the patriotic thing and donating their blood, and we all

on this panel and all of you on that panel——

Mr. UPTON. That’s until we pass campaign finance reform.

Mr. COX. [continuing] hope that this happens.

Mr. Roslewicz, the Inspector General’s report from 1995, which

I’ve just again reread, uses the word expedite. And how did that

word get in the report in 1995?

Mr. ROSLEWICZ. Okay. The process we use when we are conducting an audit is to submit a draft report for comments to the

agency before we finalize it; and FDA, when they responded to our

draft report—we didn’t use the word expedite in the recommendations. We said FDA should just establish a timeframe.

FDA had already, during the course of our audit, been working

on making some revisions to the error and accident blood reporting

process, so they asked us if we would in our final report use the

word expedite, which would then sort of—not sort of—it would

show that they were in fact trying to correct the system and make

improvements to it.

Mr. COX. Was that the Public Health Service?

Mr. ROSLEWICZ. It was the Public Health Service. At the time,

Public Health Service was the oversight agency for all of the PHS

agencies. So the Public Health Service Assistant Secretary would

have responded for Food and Drug Administration back in 1995.

Today, FDA would respond themselves to the draft report.

Mr. COX. So when they reviewed your draft report. They said,

put in the word expedite, which according to its plain English

meaning suggests hurry it up——

Mr. ROSLEWICZ. Exactly.

Mr. COX. [continuing] get it done?

Mr. ROSLEWICZ. From what they told us, they’re already working

on it. They had anticipated getting the proposed regulation out in

November 1995.

Mr. COX. They wanted this new regulation out because there

were a lot of people that aren’t reporting either promptly or at all

errors and accidents. And by errors and accidents we mean, for example, the release of blood units that are repeatedly reactive to

tests indicating, for example, hepatitis or HIV? And we’ve all understood from your testimony that this doesn’t happen all the time.

It’s rare that you would have to do a recall.

But in order to determine when a recall is in order, you’ve got

to have that information. If they don’t send you timely reports,

then FDA cannot function as an oversight agency.

34

In order to fix this problem which you’ve identified a half decade

ago, you recommended with the concurrence of the Public Health

Service that the new regulations be expedited, and so they originally said that they were going to do it many years ago, and now

they’re talking about doing it in 2001. Now, when we live in this

high-tech age where everything changes very, very fast, complex inventions are created and deployed in months, certainly a year or

two would be adequate to do most complex things in our society.

Why is it that the bureaucracy needs nearly half—this would be

more than a half decade by the time they’re done on their schedule—to read the comments and issue the regulation that originally

they said should be expedited to deal with something as important

as the safety of our blood supply?

Mr. ROSLEWICZ. Okay. We have the same question. When we

went back in August of this year, at the request of the committee

to ask that very question, we were told that they had multiple priorities going on at the same time.

Mr. COX. Did they ever tell you what they were?

Mr. ROSLEWICZ. No, we don’t know what those priorities were.

Mr. COX. Do you believe the FDA commissioner when she says

that safety of the blood supply is a top priority?

Mr. ROSLEWICZ. Do I believe her? Yes, I would certainly believe

her.

Mr. COX. Even though it’s taken a half decade to get this reg

out?

Mr. ROSLEWICZ. This is something—FDA would have to respond

to that better than I can. But my concern would be that, if there

are these priorities, what are they? We would have to go back and

do an audit to get you specific information. But, you know, we have

not audited that specific aspect of what’s happened after the

issuance of our report.

What we do do, though—we have in our organization, in the Inspector General’s Office, what we call an Orange Book. In this Orange Book are all the unimplemented recommendations that we

have made to the various agencies within our Department. And

this Orange Book repeats these findings and recommendations year

after year until they are either implemented or resolved in some

manner.

This particular report has been carried forth in all of our Orange

Books, which is provided to the Congress as well as to the various

components within our Department. So we do try to follow-up and

make sure that these things don’t fall off the scale. In this particular case, FDA is going to have to explain to you why it’s taken

so long. I can’t speak for the FDA Commissioner.

Mr. COX. I thank you. And I thank you, Mr. Chairman.

I especially want to thank our panel for your obvious interest in

this subject, making sure that our blood supply is safe and that it’s

there that we don’t have that shortage next year that Ms. Sullivan

is warning us about.

Mr. UPTON. I would just note for the record that we’ve invited

the FDA commissioner to come testify this next month when we

continue these hearings.

Mr. Strickland.

35

Mr. STRICKLAND. Thank you, Mr. Chairman, and I thank the

panel.

Mr. AuBuchon, during the early 1990’s, primarily we think because of fear of contacting HIV, we found that many patients and

families of patients contributed blood, for example, prior to surgery

and thereby increased the blood supply. My understanding is that

that practice has fallen off rather dramatically, and I was wondering if it was your feeling that we should encourage that kind of

behavior as a way of releasing our supply of blood?

Mr. AUBUCHON. Preoperative blood donation became increasingly

popular as the public’s fears about HIV in the community blood

supply increased from the mid-1980’s through the early 1990’s. Because of the public’s recognition of the increased safety of the blood

supply, beginning I would think in about the early 1990’s, there

was less motivation for patients to donate blood. It takes considerable motivation on the part of a patient to donate blood as they’re

preparing for elective surgery.

And I think the understanding that the blood supply today essentially does not carry the risk of transmitting HCV or HIV, that

the public is less interested in doing that. Once the community

blood supply becomes so short that a patient may not be able to

reliably schedule elective surgery, then there will be additional motivation for autologous donation. Until that happens, I think we

will see a decline in preoperative autologous donation.

Mr. STRICKLAND. The second question for you, Doctor. In your

testimony you talk about a lack of transfusion protocols that clearly

define when a transfusion is appropriate, when it may not be necessary in medical situations. Why is it important that such protocols be developed and who should be responsible for the development of such protocols?

Mr. AUBUCHON. Medicine attempts to be science or data driven

as much as possible, and any physician wants to know when he or

she should apply a particular therapy or when it’s not appropriate.

Although I believe I’m up to date on medical literature in terms of

transfusion, when I speak with a surgeon or a physician about

when to transfuse, I almost never have absolute data in my back

pocket to say clearly this situation has been studied and I can show

you precisely that you should take the following course of action.

I usually have to refer to studies that are similar and deal with patients who are in a similar situation, and we have to make our best

guess jointly.

Sometimes we guess wrong. The physician in charge of the patient does not want to avoid transfusing a blood component and

risk a very serious outcome when the risk of transfusion is so low.

If I go to a physician and say, if you don’t transfuse this patient,

he will do fine, and the surgeon may ask me what is the risk he

will have a heart attack, and I will say it’s probably very low. He

says, one in a thousand, one in 10,000, what’s the risk in AIDS,

one in a million.

Given those choices, the surgeon is going to transfuse. This will

make the blood supply safer. The surgeon is going to move into

that direction. So we need more data in order to establish a scientific basis for transfusion medicine.

36

Mr. STRICKLAND. I think what you’re describing is the practice

of the art of medicine versus the science of medicine, and that’s

why I believe medical decisions need to be made by persons who

are trained physicians, not only in this situation but across the delivery of our medical services.

In recent times, medical science has made great advances. And

I’m wondering, in your judgment, are we approaching the point

where blood substitutes may be practical as a way of increasing our

supply and, if so, would you estimate when such practices may become cost-effective so that they could effectively alleviate concern

about shortages?

Mr. AUBUCHON. I gave an hour-long lecture last week on that

topic with 60 slides. I won’t go into that detail for the subcommittee this morning.

I do not believe that blood substitutes are going to make a major

impact in the near future. There are artificial blood-carrying solutions for fluorocarbons which may be used in some surgical situations to allow hemodilution immediately before surgery. However,

for most patients, they are likely to save less than a unit of blood.

The hemoglobin-based oxygen carrying solutions have a little further to go, I believe, before they are potentially licensable by the

FDA.

The problem is that their source of blood is going to be primarily

human blood. There is not much outdated blood today, and with

loss of hemoglobin in the preparation, there will not be a lot of this

hemoglobin-based oxygen carrier solution available. It will also be

extremely expensive. So I do not see these, quote, unquote, blood

substitutes playing a major role in transfusion therapy in the near

future.

Mr. STRICKLAND. Thank you.

And, Dr. Heinrich, getting to this issue of preventing individuals

who may have spent 6 months in the UK from donating blood because of the fear of the human form of the mad cow disease and

given Dr. AuBuchon’s contention that sometimes we focus on the

least effective ways of increasing safety and neglecting others, looking at the loss that we would experience in the blood supply as a

result of that decision, do you think it’s justified and should we

rethink whether or not that’s a good practice?

Ms. HEINRICH. From the data that GAO collected, we found that

there’s an estimate that we would lose about 2.2 percent of units.

It’s our understanding that the various science advisory committees through FDA and the Public Health Service have said that, in

terms of the science, we don’t have all of the facts yet in terms of

the possible transmission of a new variant CJD. And in terms of

the timeframes, I think that the thinking was that 6 months is reasonable in terms of the kind of time, amount of time that one

would have to have been in the UK.

I think that the Department is also going to be continually monitoring this decision. They’re going to be looking at this on a regular

basis, to see if, in fact, there’s a problem with the supply or if

there’s anything new that comes up in terms of science.

Mr. STRICKLAND. Mr. Chairman, could I ask just one quick follow-up with Dr. AuBuchon? Is that an example of where we may

be focusing on an issue that has very minimal risk and thereby

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perhaps not focusing or neglecting to focus on things that could be

done that would have much greater impact on the supply?

Mr. AUBUCHON. Precisely. The risk of transmission of CJD

through the blood supply is clearly there. It’s a potential possibility. It’s my diligent effort to find it amongst individuals who

have come down with new variant CJD and were prior blood donors. No cases of transmission have been found. Yet every year in

this country data from the FDA and data reported to the New York

State Department of Health document that we kill 2 dozen patients

by giving them the wrong unit of blood, yet there’s no discussion

of that.

Mr. STRICKLAND. Thank you. Thank you, Mr. Chairman.

Mr. UPTON. Thank you, Mr. Strickland.

As I listen to the testimony—first of all, I appreciate again your

testimony. And I just—the first question off the top of my head

here, Ms. Sullivan, is, as you all through the NBDRC begin to collect monthly data next year, I would appreciate it if you could supply this committee with your results on a timely basis so we can

continue to monitor this. If that would be possible, it would be terrific.

Ms. SULLIVAN. Certainly.

Mr. UPTON. I’m a blood donor. But I will confess it has been a

little—when I get over this cold, I’ve already instructed my staff to

sign me up in Michigan.

Dr. Heinrich, I listened to your testimony. You indicated that

there was not a crisis, we are not in a crisis mode now, but in fact

we are below a comfort level in many regions of the country, and

in some cases, I would suspect that it’s less than a day supply; is

that right? How do those two statements comport instead of conflict?

Ms. HEINRICH. What we did is we looked at the overall numbers

and found that, indeed, the decrease has been primarily in the

autologous and directed donations, so that the community supply

for blood overall, the decrease has been about 2.2 percent. We have

heard again anecdotally that there are some regional shortages at

some times of the year and certainly for certain blood types, the

rare types O and B.

But on the other side of the equation is the fact that the ability

of our major blood banking systems, the ability to shift blood from

areas, regions where there are surpluses to areas where there is a

need, seems to have made our system run rather efficiently to meet

the demands.

Mr. UPTON. I know Richard Burr, who is the vice chairman of

this subcommittee, represents North Carolina; and I believe a number of counties in his district are flooded.

Ms. HEINRICH. Yes.

Mr. UPTON. And I heard a report earlier this week on the news

that, in fact, those areas impacted by the flooding—I suspect they

would include New Jersey and some other places I’ve seen as

well—have real trouble. And you believe then at this point from

your overview that, in fact, those areas are covered sufficiently in

terms of supply from other parts of the country?

38

Ms. HEINRICH. Our information would say that these national

systems are able to accommodate regions when there is this kind

of shortage.

Mr. UPTON. Mr. Roslewicz, what is the shelf life of a pint of blood

after it’s given until it has to be disposed?

Mr. BILBRAY. Whole blood.

Mr. ROSLEWICZ. Whole blood? I would have to defer to a doctor.

I don’t know the answer to that question.

Mr. UPTON. Dr. AuBuchon.

Mr. AUBUCHON. Whole blood itself can be stored for up to 35

days. Most units of whole blood are separated into red cells and the

plasm. The red cells can be kept for 42 days in the liquid state.

Mr. UPTON. The question, now that we have that answer, is, you

indicated in your testimony that in terms of safety, in essence, only

about 14 percent of the errors were reported in the first 30 days,

which means that 85 percent are reported after 30 days; is that

right?

Mr. ROSLEWICZ. That’s correct. As a matter of fact, another 13

percent are reported 6 months or later into years. So you have—

there’s a lot of—and it raises the question of, when you get a report

that is a year old, sort of like getting an audit that is a year old,

what good is it if you haven’t had it when the incident happened;

at least as early as possible, in order to make sure that the blood

establishment took the proper actions to correct the problem.

That’s one of the reasons why I think it’s important that they get

these reports more timely, so that they can in fact make sure that

these blood establishments are acting appropriately. There are

close to about 3,000 of them out there. Any one of these 3,000 institutions could have some kind of an error or accident and it could

happen daily. Without knowing exactly what the accident was and

what actions were taken to correct it, it becomes questionable when

a report comes in a year later as to the value of that.

I realize in their proposal that they issued in September the FDA

is recommending a 45-day maximum reporting period. That’s something that FDA proposed—we did not give them what we thought

was a reasonable period of time. But the issue you’re raising about

the shelf life is certainly something I think FDA needs to consider

when they’re making a determination.

Mr. UPTON. Do you know, though, if that consideration is going

to be taken into effect with their proposed regs that they’re planning to issue in 1901? Will they be looking at some gauge or standard to shorten that timeframe in terms of the error rate?

Mr. ROSLEWICZ. I hope they would do that. I haven’t talked to

them specifically about how they came up with the 45 days. It was

something we did not do as part of the audit that we are testifying

on today.

Mr. UPTON. Okay.

Mr. ROSLEWICZ. So I’m not sure as to what their basis was for

the 45 days.

Mr. UPTON. Mr. Bilbray?

Mr. BILBRAY. Yes, Mr. Chairman.

Ms. Sullivan, speaking to the FDA on the process—and I guess

we were just talking about them trying to get their reports and

their status-front loaded so you can respond to them. You know, I

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look at 6 years being called expedited by the FDA and, you know,

you kind of say, well, they were busy doing other things. And I

guess, Dr. AuBuchon, it was probably because they’ve been blocking this licensing of blood substitutes as it goes through the process.

I want to know when we get into this kind of a situation where

we are being projected with a 2.2 reduction, do we have any strategy or is there any program being brainstormed to how they respond to get the public to respond to the crisis, if the crisis is created? And, Doctor, if you want to answer that, I’m sorry, I directed

that to Miss Sullivan, but for any panelist.

Ms. HEINRICH. The Department of Health and Human Services,

the HHS, has recommendations.

First of all, they feel that it’s very important to increase the monitoring, and I think we’ve heard that that is ongoing. There are recommendations to increase donations from the existing donor pool.

There are recommendations to increase the donor pool since only

5 percent of those eligible are donating now. There are recommendations to improve donor relations, to develop public service

announcements and to do studies so that we better understand the

incentives for giving blood.

And another one of their recommendations, there are a few others, but another one that I think people feel is very important is

to address the economic issues that are facing our blood collection

centers.

Mr. BILBRAY. My biggest concern is that if we really do have a

plan that can be initiated as quickly as possible and to raise the

public awareness—I mean, obviously, we could have—I know a lot

of people would love to see Congress and the administration laid

out on a gurney donating blood, and maybe more than we prefer,

but that kind of public awareness, the ability to kick in that kind

of program high enough, has anybody talked about that kind of

high-profile response?

Ms. SULLIVAN. Certainly. Within the private sector, the American

Association of Blood Banks, also America’s Blood Centers, and in

fact a lot of the individual blood centers themselves have such

plans, but resources are very limited. Obviously, education recruitment campaigns are very important. Plans have been developed

particularly targeted to the younger generations, which is a considerable concern with respect to generating and encouraging new

blood donors. And what is essentially needed are additional resources to support these education and recruitment campaigns.

In addition, there are—there has been a lot of discussion of research activities, additional data collection activities that need to

be undertaken to reduce the knowledge gap. Certainly research involving today’s eligible blood donors, who gives blood, who doesn’t

give blood, why they don’t give blood, how incentives factor into

their blood donation decision, and then certainly the application of

appropriate interventions and the effect of these interventions,these are all issues that we would all love to tackle if the resources were available.

Mr. BILBRAY. I would just ask, when you say resources, that we

traditionally around here always talk spending more money on a

new program rather than tapping into resources that are out there

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already. The public relations and the public information—the public awareness potential that exists in this city and the ability for,

you know, representatives from the city to go throughout the entire

Nation on a ‘‘weekend’’ to raise that awareness, but that kind of

coordinated effort, that, you know, popularizing, the whole issue

has never been one—you see the President in foreign countries, but

you don’t see him on the in the West Wing giving blood. It may be

one of those things that we talk about as a way—let’s use this crisis as a way of raising it.

The trouble is, we’ve got the problem, and, Dr. AuBuchon, we expose the risk of expanding the universe of blood donors. Is there—

and my question is, is that a higher risk or a lower risk than utilizing those who have been in the United Kingdom and maintaining that pool?

Mr. AUBUCHON. You raise a good question, because whenever we

defer a donor for whatever reason, that donor ultimately has to be

replaced, if the supply is going to be maintained. And particularly

when we are talking about deferring a relatively large proportion,

say 2 percent of the donating population, we will have to replace

them to some extent by new donors.

New donors are known to be the riskiest donors, because they

have not been previously tested for infectious disease markers, and

their reasons for donating may not be as altruistic as the return

repeat donor.

We would like to see the donors that we have donate more frequently, but we realize there are economic pressures, social pressures and the like that not everyone is going to donate every 8

weeks. So we have to balance the risk involved in every decision.

Mr. UPTON. Excuse me just 1 second here. We have a series of

votes. We have only about 4 minutes to go. I’m not one of those

folks to miss votes. We will temporarily stop the proceedings, and

we will come back at quarter of.

[Brief recess.]

Mr. UPTON. I don’t have to set the clock. We’ve got lively debate

on the House floor. And we have a markup that’s going on in another subcommittee, so members will probably be in and out.

I have a couple more questions that I would like to ask.

One, there’s been a lot of attention with regard to this mad cow

disease, and with the new proposal that’s on the table, which is

going to be implemented, a 6-month exclusion over a period of,

what, 16 years, I guess it is. The estimate has been 2.2 percent in

terms of the drop-off of donors. Do all of you agree that that is

probably about right?

Ms. HEINRICH. When GAO did its data collection, we tried to

verify the numbers of people that go to the UK in any year. And

in terms of the numbers of people—and this was the American Red

Cross survey that gave us the estimate of 2.2, that this new regulation would affect about 2.2 percent of the supply. We think that

that’s pretty reasonable.

What you don’t know, though, is whether people, as this is publicized, how people will really respond to this. Will it increase people’s concern and, therefore, they will not donate as they have in

the past?

Mr. UPTON. One of the—Ms. Sullivan.

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Ms. SULLIVAN. If I could also add.

Mr. UPTON. Let me just clarify, too. When did that—when does

that new regulation hit? Is it soon?

Ms. HEINRICH. Now.

Mr. UPTON. It’s now. And when did it take effect?

Mr. AUBUCHON. Now.

Ms. SULLIVAN. As soon as they can begin.

Mr. UPTON. August 17. Okay. Go ahead. I’m sorry to interrupt.

Ms. SULLIVAN. The Red Cross data, the 2.2 percent primarily applies to whole blood donations. But it’s also important to realize

that apheresis—there also will be a hit on apheresis donations.

Nine million platelets are transfused in this country each year approximately and, of those, about 2⁄3 are collected by platelet phoresis. These donors actually donate, for the most part, more frequently and I have heard the figure, an average of 10 to 12 times

per year. So the deferral could in fact hit that group even harder

than the whole blood donor. So this is also something to consider.

And also we can’t really take into account without any data at

this point, the effect, the indirect effect or the self-deferral of donors who hear that they’re deferring donors who have traveled to

the UK, don’t completely understand the deferral guidance, and

they simply don’t show up at the blood center because they assume

that they landed in London 1 day, they may be deferred as well.

So there will be probably an indirect effect as well.

Mr. UPTON. Now, your studies, when they commence next year,

how quickly will you be able to ascertain whether that 2.2 percent

figure was correct, do you think?

Ms. SULLIVAN. Well, we are hoping to be including some blood

centers in our blood center sample that will be beginning some

blood centers that will initiate the deferral or implement the deferral very soon, like before the end of the year.

Mr. UPTON. Before the end of 1999 or before 2000?

Ms. SULLIVAN. Before the end of 1999. It will take some other

blood centers longer to implement the deferral. They have to make

changes in their SOPs, in their blood donor forms, their donation

records. So they won’t all begin essentially immediately or even

within the next 30 days or so. But we will try and include some

blood centers in our sample that are coming on-line early with the

implementation of that deferral and try and get data as soon as we

can.

But it will be pretty limited. It will probably be 6 months or so

before we have a sense.

In addition, those data will need to be compared with data from

the previous year, from the period when the deferral was not in effect by month. So we will need to go back retrospectively and collect some additional monthly data probably from last year for comparison.

Mr. UPTON. Dr. Heinrich, you indicated in your report that—I

mean, this is fairly well-known, that O and the B donors or that

blood supply is the shortest. I happen to be A. My wife would—I’m

not going to get into that. Why is that? Is there any reason why

O and B are traditionally on the short end of the stick?

Ms. HEINRICH. I would actually defer to Dr. AuBuchon on this.

Mr. AUBUCHON. There are several reasons for that.

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First of all, group O red cells can be transfused to any patient

regardless of their ABO group. So in situations where we need to

transfuse emergently, we don’t have time to determine the ABO

group. Or in some particular circumstances, such as in neonatal intensive care units, group O is the preferred type of blood to transfuse. That places a heavier burden on group O donors, which I happen to be one. And blood centers frequently call them to donate.

Group B is in shorter supply than one might imagine, primarily

because group B is more commonly seen in African Americans than

in Caucasians. About 20 percent of African Americans are group B

and only about 9 percent of Caucasians are group B. For whatever

reason, the donation message is not received as well in minority

communities. We are not as successful in recruiting blood donors

from minority communities. So we are undercollecting group B in

comparison to our use of group B.

Mr. UPTON. On page 2 of the GAO report, it states that about

4 percent of the allogenic blood supply expired without being transfused. Why would it have expired before it was shipped, do you

know? Do you know the reason behind that?

Ms. HEINRICH. Why?

Mr. UPTON. Why would the shelf—I presume it’s because it was

there too long, right?

Ms. HEINRICH. I think that that would be the usual. Would you

have anything more to say with that?

Mr. AUBUCHON. Yes, Mr. Chairman. About half to two-thirds of

those expiring units are group AB, which, although it’s the rarest

type of blood, can only be given to group AB recipients, and since

there are so few of those and their needs can be taken care of by

any other blood group, the AB blood is more likely to outdate.

The remainder are primarily group A, which, for the same reason, are usually only for group A recipients. So it’s not a matter

of logistics or having a better system to move the blood around. It’s

primarily this blood is just not needed.

Ms. HEINRICH. The demand.

Mr. UPTON. I understand. Thank you for that clarification.

The GAO criticized the National Blood Data Research Center

projection that the demand would outstrip available supply next

year because the projection relied on the study that overstated the

decline in blood supply. However, GAO noted that the supply of the

imported blood decreased—allogenic and imported blood decreased

2.1 percent. The community supply decreased by 2 percent, and

that same portion of losses in autologous and directed donations

would have to be replaced by units from the allogenic supply.

Given those decreases and the expected loss of 2.2 percent because of the mad cow, isn’t it still possible, do you think, that the

demand could exceed supply next year?

Ms. HEINRICH. I think that the supply and demand of the blood

system is very dynamic. And, as we’ve heard, recently some blood

centers have said that their donations are up. We have to remember that this is data from 1997. So there are a number of unknowns on the supply side and, as we discussed, there are also a

number of unknowns on the demand side.

Mr. UPTON. Ms. Sullivan, would you like to answer that? Or Dr.

AuBuchon?

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Ms. SULLIVAN. We certainly maintain that a nationwide shortage

could occur as early as next year, and we base that on the data

that we collected.

I would like to make a couple of points. To paint a picture of the

U.S. blood supply that does not fully include autologous and directed donations, as the GAO has suggested, because they are pulling the curve down essentially faster than it should be, simply

doesn’t tell the whole story, and that’s why we felt they needed to

be included.

Second, we think that it is clear, regardless of how you cut the

numbers, that donations—if donations continue to decrease and

usage is increasing, as it’s likely to do, then the lines will eventually intersect, and whether it is next year or 5 years from now, we

still need to take the same steps, we believe, to monitor the blood

supply and avoid the situation.

And we—as I announced today, we are taking steps to collect

more recent data as quickly as we can, data from 1998 and 1999,

that will enable us to refine our estimate of the available supply

for 2000.

Mr. AUBUCHON. Red cell use at our hospital had remained constant or slightly declined each year over the past 6 years. On average, about half a percent declined per year. I might like to take

credit for that for working with our clinicians about better blood

usage, but I’m not sure that really I can. However, in this year, our

red cell usage has gone up 5 percent, and that’s without the addition of any new clinical programs, without closure of any hospitals

in the area, for reasons that we can’t define. We are doing more

surgeries, and it relates—our increased usage of red cells relates to

that, but the reason we are seeing more patients coming to us, we

don’t know.

This is what is concerning to me knowing that the supply of

blood is limited and may be headed downward, and it may indeed

be that our usage is finally going upwards. We suppressed the

usage in the mid-’80’s, wringing some unnecessary transfusion out

of the system. That change occurred because of some concern about

HIV transmission. HIV certainly was not good, but the outcome in

terms of becoming more conservative in blood transfusion was

good, was useful.

I think we have done about all that we can do for the near term

in that, and as the population continues to get older, we will have

more demand on medical services and more need for transfusion.

Mr. UPTON. You know, as a layperson looking at the blood givers

and the different things that are out there to try and remind and

encourage, it’s the public service announcements on radio and TV,

and it’s different competitions—our church does a little bulletin

thing down in the basement: Next Monday, it’s going to be the day.

And I know this week, when I was back in Michigan, I

watched—Western Michigan University plays their big rival—

which is in Kalamazoo, which is, their big rival is the Central

Michigan University, so they have an annual blood drive fight. The

winner, whichever campus turns in more blood gets a nice award

at halftime of the game, and it’s traditional.

As you’ve sort of looked at other communities across the country

that often may be in a shortage of supply, what other things do you

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think have worked effectively with the Red Cross and other groups

in terms of, A, getting the message out before its dire straits like,

you know, we are shipping people home from the hospital, whatever it might be? Or what other types of events have you seen that

have been successful in raising the awareness of a community to

let them know, in fact, there is a shortage and for folks to really

come out and volunteer and donate a pint of blood?

Ms. HEINRICH. I’m sure others would like to contribute to the answer to this question.

From our data gathering, I think that’s an area that we don’t

know a great deal about, that we really feel that we found that the

experts are saying that they need more information about how to

effectively put forward campaigns. And I think that there’s also an

interest now in finding out how to target particular populations

that would be a good and dependable donor pool, if you will.

I think the other part of this is that the blood centers don’t have

incentives to collect more blood than they can use, and I think the

balance that each center will try to achieve between blood collection, blood collection from a new pool and what they project their

demand to be is a dynamic process that we don’t know a great deal

about.

Mr. UPTON. Are there some areas of the country that are traditionally more short than others in terms of having supply, and

what are those? Where have they not done as good a job in other

parts of the country by region?

Ms. HEINRICH. Our information says that New York, New York

City, Miami or southern Florida, Los Angeles, San Francisco, seem

to have chronic shortages. You probably want to add to that.

Mr. UPTON. Will your studies—in fact, as you do your monthly

studies, will it look at region by region?

Ms. SULLIVAN. Yes. We are selecting the sample so that it will

be representative by region, by size of blood center and numerous

other factors so that we will be able to analyze any potential shortages by region of the country.

Mr. UPTON. Dr. AuBuchon.

Mr. AUBUCHON. If I can just offer the comment. I’m not a specialist in donor recruitment, but I have worked in blood centers in

the past. I don’t think there’s a magic bullet to donor recruitment.

There’s no one single thing that will work in all communities or

with all potential donors. The bottom line is that it requires people

to go out and talk to people. It requires public knowledge about the

importance of blood donation, which has to begin with the childhood years and working up to the time when someone can be a

donor. And it requires enough organizational skill and manpower

to pull together a blood drive.

I think we may be beginning to see the result of the constraints

on health care spending as it’s being trickling down to the blood

centers. Hospitals have certainly seen difficult financial times over

the last decade. They’ve placed pressure on all of their suppliers,

including blood centers, to reduce costs.

Blood centers have attempted to do that. They’ve also been faced

with increasing demand for new tests and quality assurance approaches, regulatory requirements and the like. So they’re being hit

45

from that side as well. And there just isn’t—there aren’t as many

resources as there were in blood centers as there were in the past.

I would think that recognition of the special nature of blood

would be helpful and that there is an unusual commodity, it’s donated. There’s no payment for whole blood donation. The collection

is handled by a not-for-profit blood center, community blood center

or a large organization like the Red Cross, so not-for-a-profit blood

center, without great resources, and the reimbursement is coming

through a system that does not recognize blood as an individual

cost item and yet the public is wanting more, more out of that system. So it’s a difficult situation.

Mr. UPTON. Did either you or your organization, Ms. Sullivan,

Dr. AuBuchon, provide comments to the FDA with regard to the

new regulations that are supposed to be out?

Ms. SULLIVAN. Certainly the American Association of Blood

Banks, which my company is a subsidiary of.

Mr. UPTON. It was awhile ago, you know; 1996 was when they

solicited the comments.

Mr. AUBUCHON. You’re speaking of comments on error and accident reporting?

Mr. UPTON. Yes.

Mr. AUBUCHON. Yes, I did personally.

Mr. UPTON. Would you be able to provide us your comments to

the subcommittee?

Mr. AUBUCHON. I will try to find them in my files, yes.

Mr. UPTON. You’ve gotten a new computer since then, so you

have got to find them.

All of us appreciate your testimony and your willingness to come

up here today, sort of kicking off our series of hearings on this very

important topic, and we appreciate that, providing us information

that will certainly be used for questions, the FDA and others as

they come up.

And if you have additional comments or thoughts, please feel free

to pass them along to any members of the subcommittee and the

staff. We clearly are working very closely together.

So thanks very much. You’re excused. Have a nice day.

[Whereupon, at 12:10 p.m., the subcommittee was adjourned.]

[Additional material submitted for the record follows:]

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BLOOD SAFETY AND AVAILABILITY

WEDNESDAY, OCTOBER 6, 1999

HOUSE OF REPRESENTATIVES,

COMMITTEE ON COMMERCE,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:30 a.m., in room

2322, Rayburn House Office Building, Hon. Fred Upton (chairman)

presiding.

Members present: Representatives Upton, Burr, Bilbray, Bryant,

Bliley (ex officio) and DeGette.

Staff present: Alan Slobodin, majority counsel; Anthony Habib,

legislative clerk; and Chris Knauer, minority counsel.

Mr. UPTON. Okay. Good morning. This morning the subcommittee continues its oversight hearings on the safety and availability of the U.S. blood supply, and knowing that the chairman of

the full committee, also a member of this committee, is here and

knowing that he needs to be on the floor soon for the important debate on the Patients’ Bill of Rights, I will yield for an opening

statement to the chairman.

Mr. Bliley.

Chairman BLILEY. Mr. Chairman, I want to thank you for these

continued hearings concerning the safety and availability of the

Nation’s blood supply. I particularly want to welcome Dr. David

Satcher and the other witnesses for the Department of Health and

Human Services. As we learned at the previous hearing, the U.S.

blood supply is tightening and will get even tighter. We need more

blood. We also recognize that the U.S. blood supply has never been

safer. Let me repeat that. It has never been safer.

New technological advances can make the blood supply even

safer, but we still can do more to reduce the risk. Errors and accidents in the blood supply, especially transfusion errors, remain a

safety problem that can be reduced. In fact, the risk of a fatal

transfusion from a transfusion error is about the same risk as getting a transfusion with the AIDS virus. One study, based on reports to the FDA, from 1990 to 1992 found that incompatible red

blood cell transfusion continued to be the primary cause of preventable transfusion deaths and concluded that one-third of the deaths

could have been prevented by following proper procedures.

As we have learned, a well-designed reporting system is an effective safety management tool. For example, in the field of domestic

airline safety, aviation reporting systems have helped contribute to

a safety record of no fatalities in 1998. Unfortunately, the present

FDA reporting system for errors and accidents at the blood supply

58

has several weaknesses. Some of these were identified by reports

by the HHS Inspector General’s Office and the General Accounting

Office. Since the IG’s Office issued recommendations 41⁄2 years ago,

the weakness remains uncorrected, and FDA does not expect to

publish a final rule on error and accident reporting until 2001.

The American people should not have to wait until 2001 to have

a stronger blood supply safety system. We can make getting a blood

transfusion much more safe. There is an alternative reporting system with promising results that exists, and the FDA participated

in its design. The alternative model is called the medical event reporting system for transfusion medicine, which was developed by

Dr. Harold Kaplan and his team at the University of Texas. This

reporting system is supported by a research grant funded by the

National Heart, Lung, Blood Institute.

Through this committee’s investigation of blood safety, we have

learned about the exciting possibilities of this new reporting system

and brought this matter to the attention of Dr. Satcher. I am

pleased that Dr. Satcher has indicated that he is taking action to

see if it can be implemented. At the appropriate time, I intend to

ask Dr. Satcher about how the Department can assume direct control over blood reporting and accident reporting, expedite a new

policy and consider the medical event reporting system for transfusion medicine as the new reporting system for blood errors and

accidents.

Improving the reporting system is just one area this subcommittee is looking at to protect the Nation’s blood supply. We

want to be supportive of Dr. Satcher’s efforts to increase blood donations. I believe the subcommittee and Dr. Satcher can work together to give the American people the blood they need with absolutely the most safety possible.

And I thank you, Mr. Chairman, and regret that I am not going

to be able to stay to hear the testimony of the witnesses.

Mr. UPTON. Well, I would note to all the folks that are here, not

only are we very busy on the House floor, on votes that will commence in just a couple of minutes, but all of our subcommittees are

meeting as well. Some of us are on another committee, as I serve

on the Education Committee, and we are marking up Title I of the

Elementary and Secondary Education Act. So you will see a lot of

moving chairs as we work through this hearing this morning.

We do welcome today’s witness, Dr. David Satcher, who is the

Assistant Secretary for Public Health, the U.S. Surgeon General

and the Blood Safety Director, and we look forward to learning

more about the views of HHS on the blood supply, the UK donor

exclusion policy, strategies to increase the blood supply, error and

accident reporting, and the HHS blood oversight system.

At our previous hearing on September 23, we heard testimony

that suggested that we are below the comfort level in some areas

of our blood supply. The GAO testified that the blood supply as a

whole is not in crisis, but there is a cause for concern about shortages of certain blood types or in certain regions. GAO confirmed

that the available data showed that the blood supply has tightened,

even though the blood supply has declined more slowly than assumed in the projections. The National Blood Data Resource Center, NBDRC, testified that if rates of overall blood collection and

59

transfusion that occurred between 1994 and 1997 continue, the

U.S. may experience a national blood shortage as early as next

year. Dr. James AuBuchon of the Dartmouth Medical School testified that given the demographics of our population, the blood supply situation is only going to get worse, and that he did not expect

significant reductions in blood usage.

At the same time our blood supply is tightening, HHS made a

major policy change that could further reduce the blood supply. On

August 17, 1999, FDA directed that individuals who had spent a

total of 6 months or more in the United Kingdom between 1980

and the end of 1996 be prohibited from donating blood because of

concerns over the theoretical risk of spreading a new variant

human form of mad cow disease. This new donor exclusion policy

has been estimated to reduce the blood supply by 2.2 percent. At

the September subcommittee hearing, the GAO testified that this

estimate appeared to be reasonable.

At today’s hearing, I would like to examine the strategies that

Dr. Satcher and HHS are taking and considering to offset the

shortages that may result from the U.K. donor policy.

We will also follow up on a blood safety issue from the last hearing: error and accident reporting. On May 31, 1995, the Office of

Inspector General, Department of Health and Human Services, IG,

issued a report that concluded that the FDA could improve the

safety of the blood supply by doing a better job of collecting data

on errors and accidents made by hospitals and blood banks. The

audit found that the FDA was not insisting that hospitals and

blood banks submit error reports in a timely fashion, and that the

FDA does not get these reports at all from unlicensed facilities that

handle about 10 percent of the blood used in the United States.

The IG made several important recommendations to address the

issue, with which the FDA agreed. Yet here it is 4 years later, and

the FDA has yet to issue a final regulation extending the reporting

requirement to unlicensed facilities and requiring more timely reporting on the part of all of its facilities. The FDA has indicated

that the final rule will not see the light of day until February of

2001, and this in spite of the fact that the Commissioner of the

FDA has stated that blood safety is one of the agency’s top priorities.

One last issue we will want to discuss at the hearing is how well

the new HHS blood oversight system is working. In July 1995, the

Institute of Medicine issued a report that concluded that there was

a failure of leadership from the Public Health Service agencies that

may have delayed effective action against AIDS-contaminated blood

products. To address this problem, the report recommended that

HHS reorganize its oversight of blood issues by establishing a blood

safety director, a blood safety council and an expert panel. Starting

in October of that year, HHS Secretary Donna Shalala instituted

a number of changes, such as establishing the blood safety director

as the Assistant Secretary of Health. Four years have nearly

passed now since the HHS oversight system was established. It is

certainly appropriate for this subcommittee to review what has

been accomplished and what remains to be done in the stewardship

of the blood supply.

60

In addition to Dr. Satcher, I have also invited Secretary Shalala

and FDA Commissioner Henney for this hearing. I had hoped,

given the importance that both the Secretary and the FDA Commissioner have placed on blood safety, that they might have been

able to join us today. Had they appeared with Dr. Satcher, it would

have provided an even more powerful public statement from the

administration about the importance of blood donations and blood

safety. Since I intend this subcommittee to continue its oversight

of the blood supply throughout this Congress, perhaps there will be

another opportunity for these folks to appear before us.

During this oversight hearing on blood safety and availability,

the subcommittee will probably identify some areas where more

could be done. I appreciate the difficulty of Dr. Satcher’s task. I am

strongly supportive of his goal and work to increase blood donations, and I am going to be playing my role by donating blood in

Michigan next week.

Again, the policy challenges facing the blood supply have

changed in recent years, but some things about the blood supply

have not changed. There is no substitute for blood, and we need

blood donations. As Douglas Starr, the author of the book, ‘‘Blood,’’

observed, ‘‘Blood is a precious and dangerous medicine. We must be

careful how we use it.’’

And I would yield for an opening statement to the vice chairman

of the subcommittee, Mr. Burr.

Mr. BURR. Thank you, Mr. Chairman. You stimulate me to look

at my pocket and see if my due date is here for the next donation,

and I am sure that it is.

Let me take this opportunity to welcome the Surgeon General

and to express the subcommittee’s thanks for his diligence on this

issue. I think it’s safe to say that as we sit here today, not only

is the blood supply safer, as you say in your testimony, but we also

discover new health risks and technology changes when we’re able

to detect more things and also to check the blood supply.

I think the challenge for us, though we can always find fault

with Congress and with agencies, is to make a commitment that

we will make sure that the government oversight and the policies

we set in the future are as seamless as the technology and the

health risks that we will face in the future; that it won’t take an

oversight committee of Congress or a delay from an agency to

change the policy to reflect the safeguards that the American people need.

I’m confident that we have the right formula in those agencies

and the Surgeon General and in this Congress that we can accomplish this with the highest degree of confidence. I look forward to

working with you, Mr. Chairman, and with the Surgeon General to

make sure that seamless world is one that we can achieve.

I thank you.

Mr. UPTON. Mr. Bilbray.

Mr. BILBRAY. Yes, Mr. Chairman. Mr. Chairman, I would like to

echo Chairman Bliley’s statement. I think a lot of us, as we approach these situations where we see that there’s improvement can

be done, we sort of forget about highlighting how much success

we’ve had in the past. Let me just say as somebody who’s had 25

years involvement in different public health issues and environVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00063 Fmt 6601 Sfmt 6601 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
61

mental health issues, we need to be reminded that the air today

is cleaner than it has ever been in the history of the United States;

that our water is cleaner than it’s ever been in the history of the

United States; our drinking water is safer than it’s ever been in the

history of the United States. There is less risk from hazardous

waste today than there has ever been in the near past, and the fact

is, our blood supply is safer than it has ever been in the history

of this country.

So I think starting from that basis, that we’re not coming from

a crisis of how terrible things are, but the fact that things are as

good as they have been in the past, that we need to move forward

and continue the process of improvement, continue to refine the

safeguards, and I think that what we’re looking for here now is

how we can we do that fine-tuning to continue the evolution toward

a safer, more healthy society for all citizens. And I appreciate the

fact that we are trying to work together here in a bipartisan way

with the administration and the Congress, and I look forward to us

taking that next step. And there may not be a huge leap, but it’s

those small, little steps that have added up in the past, and those

steps are the important steps that we need to make for the future.

I yield back, Mr. Chairman.

Mr. UPTON. Thank you.

Those of you all who heard those buzzers, it means we do have

a vote on the floor. We’ll temporarily adjourn. We will come back

at about 11 o’clock.

[Brief recess.]

Mr. UPTON. It must be 11 o’clock. We are going to keep the

record open for any opening statements that other members may

make. So I make unanimous consent that the record be open for

any opening statements, and at this point we’ll proceed with the

opening statement of Dr. Satcher.

As you know, it is customary of this subcommittee to take testimony under oath. Do you have any objection? Are you planning to

have counsel with you or others?

Mr. SATCHER. No. I would like for the colleagues that I might call

upon in the question period to stand with me and take the oath.

Mr. UPTON. If you could so identify them and have them maybe

join with you, that would be perfect.

Mr. SATCHER. There will be three. Dr. Kathy Zoon is the Director

of the Center for Biologics Evaluation and Research; and with her

is Dr. Jay Epstein, who is Director of the Office of Blood Research

and Review in the same center; and Dr. Steven Masiello, who is

the head of the Office of Compliance and Biologics Quality. They

might well be called during the question-and-answer period.

Mr. UPTON. If you all would raise your right hand.

[Witnesses sworn.]

Mr. UPTON. You are now under oath, and again, we welcome you

to this subcommittee, and you may proceed with your opening

statement. Certainly, as a matter of courtesy, your statement in its

entirety is made part of the record, and the time is now yours.

62

TESTIMONY OF DAVID SATCHER, ASSISTANT SECRETARY FOR

HEALTH AND SURGEON GENERAL, DEPARTMENT OF

HEALTH AND HUMAN SERVICES, ACCOMPANIED BY KATHRYN ZOON, DIRECTOR, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, STEVEN A. MASIELLO, DIRECTOR, OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY, CENTER

FOR BIOLOGICS EVALUATION AND RESEARCH, AND JAY S.

EPSTEIN, DIRECTOR, OFFICE OF BLOOD AND RESEARCH REVIEW, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION

Mr. SATCHER. Thank you, Mr. Chairman and members of the

Subcommittee on Oversight and Investigation of the Committee on

Commerce. Thank you for inviting me to discuss the safety and

availability of the blood supply. This is really a critical issue, and

we appreciate this opportunity.

Our Nation’s blood supply is safer than it ever has been and is

getting safer as we speak. Dr. AuBuchon, who testified before you

last month, reported that just 2 years ago the risk of hepatitis C

from blood transfusions was about 1 in 100,000 transfusions, or

about 120 cases a year. He also reported that the risk of HIV was

about 1 in 500,000 transfusions, or about 24 cases per year. We

have made tremendous progress, especially when you reflect on the

fact that it was not that long ago that the risk of hepatitis C was

at least 50 times greater.

One of my most memorable experiences as Director of the CDC,

of course, was meeting with the National Hemophiliac Foundation

a few years ago and revisiting their experience in the early to mid1980’s when over that half of that population was infected with

HIV. We have come a long way, but the issue of the safety of the

blood supply is still a very critical issue.

We have recently introduced the nucleic acid test for hepatitis C

and HIV into development. Most of the older tests which produce

the results that Dr. AuBuchon described detect antibodies to these

viruses, but in contrast, nucleic acid tests detect the viruses themselves. For this reason, nucleic acid tests may help us to close the

so-called window period between the time an infectious agent appears in the blood and the time that infections can be detected.

As you know, currently nucleic acid tests are investigational and

are being evaluated widely using pools of donated blood. Even more

sensitive nucleic acid tests performed on single units are under development. Collectively these advances should reduce the risk of

transfusion-transmitted hepatitis C and HIV by a large order of

magnitude and possibly even more.

I want to say a word about what I think we’ve accomplished in

terms of blood safety since we reorganized our strategy for protecting the blood supply. First, we have prioritized blood safety

within the Department. Our efforts to increase the safety of the

blood supply began in the earliest days of this administration. In

July 1993, Secretary Shalala commissioned the Institute of Medicine to prepare a report on the introduction of HIV into the blood

supply. She did this, as she said at the time, to ensure the safety

of the Nation’s blood supply against new challenges in future.

The Institute of Medicine released its report in July 1995. On the

same date that it was released, the Secretary directed Dr. Lee,

63

then the Assistant Secretary of Health and senior member of the

Department, to review it. In October of that year, in testimony before Congress, the Secretary announced her concurrence with this

report, and I must say I was then Director of the CDC, and I was

involved in all of these deliberations. She also announced that she

had designated the Assistant Secretary for Health to be the blood

safety director for the Department. In addition, she announced the

establishment of two high-level committees on blood safety and

availability, one internal and one external to the Department.

The Secretary concluded her testimony by saying blood and blood

products will always be capable of transmitting diseases, and their

use will never be completely free of risk. But for everyone who relies on blood and blood products to sustain life, the Federal Government will do everything in its power to reduce risk and to assure

availability.

We are implementing the Secretary’s policy in three ways: No. 1,

working for the timely introduction of new technologies such as the

nucleic acid testing; two, a proactive response to the threats posed

by emerging and reemerging infectious diseases such as transmissible spongiform encephalopathies; and three, increased attention to quality assurance, such as an emphasis on current, good

manufacturing practice requirements.

We believe that these three initiatives will permit us to achieve

the degree of blood safety that the American people demand without compromising the blood availability that the American people

need.

What is our blood action plan? I feel it’s important to stress in

light of earlier discussions by the committee the commitment of the

Food and Drug Administration to increasing effectiveness of regulation of the blood industry. The concrete expression of this commitment is the Blood Action Plan which was initiated in July 1997.

The Blood Action Plan is one of the FDA’s responses to the 1995

Institute of Medicine report and also to several congressional oversight reports since that time.

The Blood Action Plan establishes a comprehensive review of all

blood-related regulations. Most of this review has been completed.

In May and August of this year, the FDA published direct final

rules and companion proposed final rules that updated technical

standards for blood and blood products. In August of this year,

FDA proposed two additional rules, one on testing blood donors for

infectious diseases and another on donor notification. But also in

July of this year, FDA proposed an important consumer safety initiative, a tracking system for plasma derivatives from manufacturer through the distribution network to the end user, that will

ensure prompt notification when indicated.

Progress has been made in improving the responsiveness of the

agency. Under the Blood Action Plan, FDA is harmonizing its new

biologics license application for blood products with its new drug

applications. In addition, I think it’s important to note that the

Food and Drug Administration is working with the CDC and NIH

representatives and have formed an emerging infectious disease

committee that has developed plans for responding to emerging infections that threaten the blood supply.

64

I do want to point out, Mr. Chairman, that I think there are

global implications to the safety of our blood supply, and as you

probably remember, a few years ago when I was Director of CDC,

we proposed a global system of surveillance and response for

emerging infectious diseases, and that proposal was approved, and

we are now in the process working with our G-8 partners and others of implementing such a system.

FDA has also recognized its field inspection programs and has

reorganized these programs, and as a result, there has been considerable progress toward bringing the blood and blood product industries into full compliance with current good manufacturing practice

requirements.

In the past, we have talked about the hepatitis C look-back program, and in the interest of time, I will only mention the Department’s initiative to notify all individuals who may have inadvertently been exposed to hepatitis C through blood transfusions. FDA

has moved rapidly to issue guidance on this initiative and is moving rapidly as well to issue a final rule on this matter. I think the

role of the CDC and the FDA in collaboration with the Agency for

Health Care Policy and Research will allow us to implement an effective program and to evaluate that program as it goes forward.

So we’re committing to not only implementing this look-back, but

being able to tell you how effective this program is being throughout the country.

One of the major issues that you have discussed recently and

that we have been concerned about is the defense against the

transmissible spongiform encephalopathies. Over the past 4 years,

the Department has substantially updated its policies regarding

TSEs, if you will. These include Creutzfeldt-Jakob disease, or CJD,

and this new variant CJD, the human form of mad cow disease, if

you will. Animal experiments indicate that both are potentially

transmissible by blood transfusion, but it’s important to point out

that no actual case of this has been thus far observed in humans.

This surveillance system that we have in place through the CDC

really goes back to 1979, and we have been monitoring very closely

for the occurrence of CJD and any form of it. So we’re very confident about the data.

Extensive epidemiologic data has permitted us to revise some

precautions against CJD. However, new and disturbing information

about this new variant CJD has recently become available. We

have learned that the prions of new variant CJD are quite different

from classic CJD in many ways, but let me say that this may explain why the clinical manifestation of the two diseases tend to be

so different. We have learned that the new variant CJD forms deposits in peripheral tissues, like lymph nodes and the spleen and

the tonsils, and there is some preliminary evidence in transgenic

mice that suggests a role for certain blood cells in the pathogenesis

of this disease, and I think you can see, therefore, why, even

though there’s no evidence that this is transmitted in the blood, we

have not reached the level of comfort that would prevent us from

taking action.

We’ve learned that the risk of new variant CJD is uniformly distributed throughout the United Kingdom. In fact, the only definable risks of new variant CJD at present are long-term residence

65

in the United Kingdom and the methionine homozygosity at codon

129 of the prion protein gene.

The first critical piece of information we currently lack is the

length of the incubation period between exposure to the agent of

a new variant CJD and the onset of the symptoms. This is a really

critical issue. I think if we were to assume that the incubation period in humans were the same as in cows, we would assume that

it was about 5 years, and therefore, we would expect no more than

about 500 victims. Even that assumption is open to some question.

However, the incubation period in humans could be as much as 40

years, and that means that we could have as many as 500,000 victims of this new variant CJD.

I think the other critical piece of information we currently lack

is whether this new variant CJD is, in fact, transmitted by a blood

transfusion in man. So far there is no evidence that this has occurred, and as you probably know, we have had no evidence that

CJD itself has been transmitted through the blood and humans.

And without going into a lot of detail, we have followed the evolution of this, especially looking at the hemophiliac population, persons with thalassemia, persons with sickle cell disease, all people

who receive a lot of transfusions, and there’s no evidence today

that that population is at any greater risk for CJD than any others.

So we are pretty comfortable, even though not comfortable to stop

monitoring this very carefully, but we have no evidence to date

that CJD itself is transmitted through blood transfusions.

The Food and Drug Administration’s Transmissible Spongiform

Encephalopathy Advisory Committee made recommendations on

June 2 of this year regarding donor deferral based on a period of

residence or travel in the United Kingdom to the blood safety committee which I chair, and we voted unanimously to support that,

and it was really out of that committee that we recommended that

persons who had spent up to 6 months in the United Kingdom between the years of 1980 and 1996 be deferred from blood transfusions. There is, as you know, some disagreement with that, but

I do want to point out that we felt that if we were going to err,

we should err on the side of being very cautious.

We were concerned about the impact that this would have on the

blood supply. According to our data and our estimates, this could

potentially reduce the blood supply by 2.2 percent, but it would, on

the other hand, take care of 87 percent of the days of risk that we

would experience from that group of people. So we felt that this

was the right decision. However, the main point I want to make

today is that this is a decision that we will continue to revisit at

least every 6 months. So as we speak, we are evaluating the impact

that this decision is having.

The next point I want to make is a word about the availability

of blood and what we’re trying to do to assure that blood availability is enhanced in this country. At the June 8 meeting of the

Blood Safety Committee, I did appoint an Interagency working

group to make recommendations to me about ways that we could

enhance the blood supply, and they made their recommendations,

which I have accepted, and there are five areas of recommendation.

One is, of course, that we do a better job of monitoring the blood

supply, and we have committed up to $300,000 in the current fiscal

66

year from NHLBI to purchase this information from the National

Blood Data Resource Center. So we are going to be monitoring

much more carefully the blood supply and seeing what’s happening

to donations.

We’re also going to do more to encourage the public to donate

blood. I was very happy to hear about your commitment and others

on the panel. I hope to do a much better job as Surgeon General

of communicating to the American people in general the importance of donating blood, as well as donating organs. A lot of lives

can be saved, and we’re going to make that a much greater part

of our deliberations.

The NIH has committed $1.8 million in the current fiscal year

to research strategies that can be used to enhance donation.

The third thing that this committee recommended and we accepted was that we needed to work on improving the relationship between donors and the blood establishment. There are donors who

complain about the experiences that they have when they go to donate blood. So we’re going to see how we can really improve that

relationship in many ways.

We also are going to remove unnecessary restrictions to donations. This is a very important recommendation because we believe

that there is much more blood available than we’re receiving because of some unnecessary restriction. So we are going to review

the current donor deferral policies, particularly in light of emerging

technologies, such as nucleic acid testing. FDA’s decision to reassess donations by individuals with hemochromatosis that was announced on August 10 by Commissioner Henney is only one of several responses to this issue that we are now considering.

And finally, we’re going to address economic concerns of the

blood industry as it relates to blood donations. What I didn’t say,

which I should mention because I don’t know how many people are

aware, that about 60 percent of the people in the population are

really eligible for blood donation, and yet only about 5 percent are

donating. The other thing, of course, is that of the people who donate, many of those persons could donate many more times a year

than they are. Most of them donate once a year. So we are working

on those two things at the same time.

The other Departmental initiatives in blood safety which I’ll

mention just briefly as I close is to look at the issue of accidents

and errors associated with blood administration, which Congressman Bliley mentioned. FDA has long recognized the importance of

reporting investigation and correction of errors and accidents. The

FDA has already used information learned from the errors and accident reports to identify areas where clinical practice and government regulations could be improved, and FDA issued a proposed

rule in 1997 to require unlicensed, as well as licensed, institutions

to file these reports, and they quantified a time period in which

they should be filed. However, the final rule of this matter has yet

to be issued.

It is important to emphasize that the error and accident reporting required under this rule serves not to alert the FDA to emergencies, but to provide an additional layer of data for quality assurance for longer-term safety monitoring, audits and to help support

for target inspections. The major proactive approach to assuring

67

high quality and compliance with the regulations of the blood industry is, in fact, FDA’s regular inspection process. In fact, the vigorous and rigorous FDA inspection program has led in recent years

to a number of major enforcement actions to help assure the safety

of the blood.

Mr. Chairman, I would like to join your fellow committee members who have thanked you for holding this hearing because you

have raised awareness of an essential layer of the blood safety system. I want to assure you that none of us are waiting for the time

required to issue a final rule to address this important matter. As

you know, on August 13 of this year I had directed the Advisory

Committee on Blood Safety and Availability to place this matter on

their agenda. This is a very talented advisory committee, very diverse in terms of its expertise, and they will be looking critically

at this matter. This meeting in which they will discuss this issue

is scheduled for late January of 2000, and preparation for it is already under way.

Congressman Bliley mentioned Dr. Harold Kaplan, professor of

transfusion medicine, who has been awarded a research grant by

the National Heart, Lung, and Blood Institute to study transfusion

errors and how it might be reduced. The Department will promptly

consider any recommendations that arise from this meeting. We

will not wait until 2001 to respond. We will move as expeditiously

as possible to put in place recommendations to enhance or reduce

errors and accidents, and we’d be delighted to inform of you our response to these recommendations.

Thank you.

[The prepared statement of David Satcher follows:]

PREPARED STATEMENT OF DAVID SATCHER, ASSISTANT SECRETARY FOR HEALTH AND

SURGEON GENERAL, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Mr. Chairman, Members of the Committee: Thank you for your invitation to discuss the safety and availability of the blood supply.

I. RECENT ADVANCES IN BLOOD SAFETY

Our nation’s blood supply is safer than it ever has been, and it is getting safer

even as we speak. Dr. AuBuchon, who testified before you last month, reported just

two years ago that the risk of hepatitis C from blood transfusion was about one in

one hundred thousand transfusions, or about 120 cases per year. He also reported

that the risk of HIV was about one in five hundred thousand transfusions, or about

24 cases per year.

Since then, nucleic acid tests for hepatitis C and HIV have been developed. Most

older tests, which produced the results Dr. AuBuchon described, detect antibodies

to these viruses. In contrast, nucleic acid tests detect the viruses themselves. For

this reason, nucleic acid tests may help us close the so-called ‘‘window period’’ between the time an infectious agent appears in the blood and the time that infection

can be detected.

Currently, nucleic acid tests are investigational, and are being evaluated widely

using pools of donated blood. Even more sensitive nucleic acid tests performed on

single units are under development. Collectively, these advances should reduce the

risk of transfusion-transmitted hepatitis C and HIV by an order of magnitude, and

possibly even more.

II. DEPARTMENT ACCOMPLISHMENTS IN BLOOD SAFETY

A. Prioritization of Blood Safety Within the Department

Our efforts to increase the safety of the blood supply began in the earliest days

of this Administration. In July 1993, Secretary Shalala commissioned the Institute

of Medicine to prepare a report on the introduction of HIV into the blood supply.

68

She did this, as she said at the time, ‘‘. . . to insure the safety of the Nation’s blood

supply against new challenges in the future.’’

The Institute of Medicine released its report in July 1995. On the day it was released, the Secretary directed Dr. Lee, then the Assistant Secretary for Health, and

senior members of the Department to review it. In October of that year, in testimony before Congress, the Secretary announced her concurrence with the report.

She also announced that she had designated the Assistant Secretary for Health to

be the Blood Safety Director for the Department. In addition, she announced the

establishment of two high-level committees on blood safety and availability, one internal and one external to the Department. The Secretary concluded her testimony

by saying

Blood and blood products will always be capable of transmitting disease, and

their use will never be completely free of risk. But for everyone who relies on

blood and blood products to sustain life, the Federal Government will do everything in its power to reduce risk and assure availability.

We are implementing the Secretary’s policy by:

1. Timely introduction of new technologies, such as nucleic acid testing;

2. Proactive response to the threats posed by emerging and re-emerging infectious

diseases, such as transmissible spongiform encephalopathies; and

3. Increased attention to quality assurance, such as emphasis on current Good Manufacturing Practice requirements.

We believe that these three initiatives will permit us to achieve the degree of

blood safety that the American people demand without compromising the blood

availability that the American people need.

B. Blood Action Plan

I feel it is important to stress, in light of earlier discussion by this Committee,

the commitment of the Food and Drug Administration to increasing the effectiveness of regulation of the blood industry. The concrete expression of this commitment

is the Blood Action Plan, which was initiated in July 1997. The Blood Action Plan

is one of FDA’s responses to the 1995 Institute of Medicine report, and also to several congressional oversight reports since that time.

The Blood Action Plan established a comprehensive review of all blood-related

regulation. Most of this review has been completed. In May and August of this year,

FDA published Direct Final Rules, and companion Proposed Final Rules, that updated technical standards for blood and blood products. In August of this year, FDA

proposed two additional rules, one on testing blood donors for infectious diseases,

and another on donor notification. Also, in August 1999, FDA proposed an important consumer safety initiative: a tracking system for plasma derivatives from manufacturer through the distribution network to the end user that will insure prompt

notification when indicated.

Progress has also been made in improving responsiveness of the Agency. Under

the Blood Action Plan, FDA is harmonizing its new Biologics License Application

for blood products with its New Drug Application. In addition, FDA, CDC, and NIH

representatives have formed an Emerging Infectious Diseases Committee that has

developed plans for responding to emerging infections that threaten the blood supply. FDA has also reorganized its field inspection programs. As a result, there has

been considerable progress towards bringing the blood and blood products industries

into full compliance with current Good Manufacturing Practice requirements.

C. Hepatitis C Lookback

In the interest of time, I will only briefly mention the Department’s initiative to

notify all individuals who may have been inadvertently exposed to hepatitis C

through blood transfusion. FDA has moved rapidly to issue Guidances on this initiative, and it is moving rapidly as well to issue a Final Rule on this matter. As part

of this effort, CDC is coordinating a Hepatitis C Public Information Campaign and,

in collaboration with FDA and the Agency for Health Care Policy Research, will

carefully evaluate both the targeted and the general notification efforts.

D. Defense Against Transmissible Spongiform Encephalopathies

Over the past four years, the Department has substantially updated its policies

regarding the transmissible spongiform encephalopathies. These include

Creutzfeldt-Jakob disease, or CJD, and new variant CJD, the human form of ‘‘mad

cow’’ disease. Animal experiments indicate that both are potentially transmissible

by blood transfusion, but no actual case of this has so far been observed in humans.

Extensive epidemiologic data has permitted us to revise some precautions against

CJD. However, new and disturbing information about new variant CJD has recently

become available. We have learned that the prion of new variant CJD is different

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from the prion of classic CJD. This may explain why the clinical manifestations of

the two diseases are so different. We have learned that the prion of new variant

CJD forms deposits in peripheral tissues, and there is some preliminary evidence

in transgenic mice that suggests a role for certain blood cells in the pathogenesis

of this disease. We have learned that blood from rodents experimentally infected

with Mad Cow Disease can, under some circumstances, transmit it to other rodents.

We have learned that the risk of new variant CJD is uniformly distributed throughout the United Kingdom. In fact, the only definable risks of new variant CJD at

present are long-term residence in the United Kingdom, and methionine

homozygosity at codon 129 of the PRNP gene.’’

The first critical piece of information we currently lack is the length of the incubation period between exposure to the agent of new variant CJD and the onset of

symptoms. In cows it is five years. If it is also five years in people, there may be

no more than 500 victims of this disease. However, if the incubation period is up

to forty years, there could be more than 500,000 victims of new variant CJD.

The other critical piece of information we currently lack is whether new variant

CJD is in fact transmitted by blood transfusion in man. No such instance has yet

been identified, but the possibility has not been excluded. Some have suggested that

we take no action until the first case of transfusion-transmitted new variant CJD

is documented. However, by that time, how many others might be irreversibly infected with a uniformly fatal disease that destroys the brains of its victims in the

prime of their lives? We have chosen to reduce this risk by the limited methods now

available to us, and not wait until the answer reveals itself.

In formulating our policies, we have repeatedly invited comment from scientists,

the blood industry, and the public on their perception of the risk to blood safety

posed by new variant CJD to blood safety, the impact of any measures we might

take to reduce that risk, and what we could do to minimize that impact. As we expected, the advice varied. For this reason, we followed the process established by

Secretary Shalala in 1995, which was to bring this matter promptly to the highest

level of the Department. The Food and Drug Administration’s Transmissible

Spongiform Encephalopathy Advisory Committee made their final recommendation

on June 2 of this year regarding donor deferral based on a period of residence or

travel in the United Kingdom; the Blood Safety Committee, which I chair, met on

June 8. The Blood Safety Committee’s recommendation was unanimous in favor of

this precautionary measure. FDA announced this recommendation at its Blood Products Advisory Committee meeting on June 17, and FDA’s Guidance to Industry was

issued on August 16.

III. DEPARTMENT ACTIONS TO ASSURE THE AVAILABILITY OF BLOOD

At the June 8 meeting of the Blood Safety Committee, I appointed an Interagency

Working Group to identify strategies to increase the blood supply. I received their

report on August 10, and discussed it at the August 26 meeting of the Advisory

Committee on Blood Safety and Availability. I concur with each of their recommendations, both for the short and the long term, and I have directed the appropriate agencies to implement these recommendations as soon as possible. Much of

this implementation has already occurred.

A. Monitor the Blood Supply

The first recommendation of the Interagency Working Group was to institute prospective monitoring of the blood supply. The NIH has committed up to $300,000 in

the current fiscal year to purchase this data from the National Blood Data Resource

Center, beginning as soon as possible, and perhaps even this month. Plans for longterm management of this activity are currently under review.

B. Encourage the Public to Donate (And to Continue Donating)

The second recommendation was to increase suitable donations. As the General

Accounting Office report to your Committee pointed out, there are plenty of eligible

donors; we simply need to find more effective ways to encourage them to donate.

The NIH has committed $1.8 million dollars in the current fiscal year to research

in this area.

C. Improve Relations Between Donors and Blood Establishments

The third recommendation was to improve relationships between donors and blood

centers. While much of this task is the industry’s, the Department will consider

steps that it can take. For example, there may be ways to make required donor

questionnaires less burdensome without making them less effective.

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D. Remove Unnecessary Restrictions to Donation

The fourth recommendation was to review current donor deferral policies, particularly in light of emerging technologies such as nucleic acid testing. FDA’s decision

to reassess donations by individuals with hemochromatosis that was announced on

August 10 by Commissioner Henney is only one of several responses under active

consideration by FDA.

E. Address Economic Concerns of the Blood Industry

The fifth and final recommendation was to address economic pressures on the

blood industry that may limit its performance. The Advisory Committee on Blood

Safety and Availability reviewed this issue at its August 27 meeting. The Committee’s recommendations are currently under review within the Department.

IV. OTHER DEPARTMENTAL INITIATIVES IN BLOOD SAFETY

Another issue that both we and you have under active review is accident and

error associated with blood administration. FDA has long recognized the importance

of reporting, investigation, and correction of errors and accidents. FDA has already

used information learned from error and accident reports to identify areas where

clinical practice and government regulation could be improved. FDA did issue a Proposed Rule in 1997 to require unlicensed as well as licensed institutions to file these

reports, and to quantify the time period in which they should be filed. However, a

Final Rule on these matters has not yet been issued.

It is important to emphasize that the error and accident reporting required under

this rule serves not to alert the FDA to emergencies, but to provide an additional

layer of data for quality assurance, longer-term safety monitoring, audits, and to

help target inspections. The major proactive approach to assuring high quality and

compliance with regulations in the blood industry is FDA’s regular inspection process. In fact, the vigorous FDA inspection program has led, in recent years, to a number of major enforcement actions which have helped assure blood safety.

Mr. Chairman, I would like to join your fellow Committee members who have

thanked you for holding this hearing, because you have raised awareness of an essential layer of the blood safety system. I want to assure you that none of us are

waiting for the time required to issue a final rule to address this important matter.

As you know, on August 13 of this year I had directed the Advisory Committee on

Blood Safety and Availability to place this matter on their agenda. This meeting is

scheduled for late January 2000, and preparations for it are already under way. One

of the invited speakers will be Dr. Harold Kaplan, the Professor of Transfusion Medicine at Columbia University, who has been awarded a research grant by the National Heart, Lung, and Blood Institute to study transfusion error and how it might

be reduced. The Department will promptly consider any recommendations that arise

from this meeting, and I would be delighted to inform you of our response to these

recommendations as soon as it is formulated.

I would be happy to answer any questions you may have.

Mr. UPTON. Well, thank you very much for your testimony, and

again, I apologize for Members who are not here, but we do have

a number of activities going on in committee that require all of our

attention.

As I indicated in my opening statement, I am planning to donate

blood next week, and I am going to be donating it through my local

Red Cross facility back in Michigan. We don’t have votes on Monday, and I know that the Red Cross, of course, complies with all

the regulations. They are, in fact, licensed. They have inspections.

They have prompt reporting of any error and accident rates, and

all of us want very much to know and be assured that, in fact, all

of the blood supply, 100 percent, is sufficient in terms of its level

and that it is safe.

And one of the concerns that I know Chairman Bliley raised earlier and all of us share is that, in fact, we’re not perhaps at that

100 percent level. And you referenced the regulations that were put

out for comment back in 1997—a good year for the Michigan Wolverines, national champs, and we’re looking to repeat again this

year—but you know, 10 percent of the blood collected, in fact, goes

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to unlicensed facilities that, as I understand it, are inspected

maybe not more than once every 1 or 2 years. The definition of

prompt reporting of errors and accident rates—it’s all relative. Who

knows what it is. In fact, furthermore, we learned that there are

a number of blood transfusion centers that have no oversight by

the FDA at all but, in fact, are overseen by HCFA. Is that right?

Mr. SATCHER. Well, there are some programs that come under

HCFA because they are funded through Medicare and Medicaid, so

that is true.

Mr. UPTON. But there’s a mishmash of stuff that does not sort

of bring the full regulatory oversight to 100 percent of the blood

supply; is that not right?

Mr. SATCHER. I would say that’s correct, and I think that that’s

what we’re looking to correct.

Mr. UPTON. Well, Chairman Bliley indicated earlier today when

he was here at the committee that one-third of the transfusion-related deaths could have been prevented by eliminating human errors in the processing of blood. Unfortunately, the FDA has yet to

implement the regulations providing for more timely reporting and

more comprehensive reporting of the error and accident rates as

recommended by both the GAO and the Inspector General, and

there are a lot of us that are not happy about waiting until the

year 2001. That’s a long time away.

Chairman Bliley raised earlier today that as the airline industry

is required to promptly report all of the problems that may happen

in the air. They have learned from those mistakes, and we had a

100 percent safety record, as I recall, this last year, no deaths.

That has not been the case with blood safety. A question that I

have for you, particularly as you look to the meeting that you referenced in January coming up a couple of months from now, would

you be willing as the blood safety director to assume control over

the policy of error and accident reporting, to put the medical event

reporting system for transfusion medicine before that meeting and

report back to this subcommittee next March or so on whether or

not you can implement the error and accident reporting initiative

way before they might otherwise come to it in 2001? Would that

be something you’d be willing to discuss and put on the agenda?

Mr. SATCHER. Yeah. In essence, in our mind that’s what I’ve

done. My intent is that——

Mr. UPTON. In other words, we want someplace where the buck’s

going to stop, and we don’t want to wait a couple more.

Mr. SATCHER. I take responsibility for blood safety and availability. I think my role as Assistant Secretary for Health puts me

in charge of the Blood Safety and Availability Committee in the

Department. We have an outside advisory council to whom we take

issues so we can get the kind of input that we need to make the

right decisions. So I take that responsibility very seriously, and I

have talked with Commissioner Henney, and she is well aware that

we’re going to move forward when we get the information we need

to deal with errors and accidents. We are not waiting until the year

2001.

Mr. UPTON. You think that you can implement a system that, in

fact, will be in place way before 2001 so, in fact, 100 percent of the

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blood collected will be regulated and we can be assured that it’s

safe?

Mr. SATCHER. I don’t want to preempt the committee.

Mr. UPTON. You’ve got a couple of——

Mr. SATCHER. I don’t want to preempt the January meeting. I

can tell you what I think, but it wouldn’t be fair for me to say to

an advisory council, I want you to put this on your agenda, I want

you to bring the best minds in the country to testify, and then

when we finish that meeting, we’re going to make a decision about

how rapidly we can move, and I will report back to you. It is my

intent to move as rapidly as possible, yes, but I do want to go

through the process. I wish it would have happened faster, but this

is where we are. We have set in this place, this process of bringing

it before a very outstanding advisory council. Dr. Harold Kaplan

will be there to testify, and we’re going to move as rapidly as possible following that.

Mr. UPTON. Well, we’d like to light the fire underneath that

meeting to be sure that it comes into place because we don’t want

to wait. We raised this at our hearing we had back in September.

From 1997 to 2001 is too long. I don’t know of any regulation in

this administration or the last couple that has waited and languished that long on an issue that everyone, everyone will acknowledge is one of the most important things that we need to assure

the American public that it is safe, particularly when we see the

evidence that as much as 10 percent has regulation that’s pretty

lax. Every year or 2 someone might come by and inspect the

records versus accurate and prompt reporting of any error or accident. If other agencies are able to do it, there’s no reason why we

can’t try to expect the same for something just as vital as this one.

Your leadership will be most appreciated in crossing that touchdown line.

Mr. SATCHER. I appreciate that. It’s not my intent, and I try to

avoid doing that, to make excuses for what has not happened, but

in fairness to FDA and others, I don’t think they have just been

sitting and waiting. I think we have made a tremendous progress

in this area while dealing with hepatitis C issues and several other

major issues in blood safety where we, as you have pointed out,

have made tremendous progress in the last 2 or 3 years. So they

have not just been waiting, and I think if you look at the data in

terms of the number of deaths that have occurred from blood transfusions, they have been coming down rapidly. I think it’s about,

what, 45 to 50 per year now based on, you know, the blood itself

that’s being transfused.

We have made tremendous progress. We will not be satisfied

until we have in place a system that is optimal for protecting the

blood supply and the safety of the transfusion itself,but they have

not just been sitting and waiting. They have been involved in a

process that I would agree I think we can move more rapidly, and

we’re going to move more rapidly.

Mr. UPTON. So you are not happy about the delay either then?

Mr. SATCHER. I am not happy about the delay, but I also understand people have made a lot of progress in the system while we

have been, as you say, waiting for the formal, the final rules.

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Mr. UPTON. What would you say about the blood transfusion centers? Are their regulations that you would like to see come into

place, put it under one body instead of others such as we have

learned with HCFA?

Mr. SATCHER. Well, I think—again, I think that’s what—I’d like

to wait and see what works best. There is a reason for things being

the way that they are in terms of efficiencies, and we’re going to

look at that. That is one of the issues that we will be looking at,

but again, I get criticized when I don’t allow the advisory council

to advise us before we make decisions and commitments, and I

don’t want to be guilty of that, and I don’t think it’s the best way

to run this operation. So I will listen very carefully to the input

from that council and will act on the best information expeditiously. That I will promise you.

Mr. UPTON. Well, we look forward to hearing back.

At this point, I yield to the vice chairman Mr. Burr.

Mr. SATCHER. If you would like to hear more details from Dr.

Zoon.

Mr. UPTON. I’m sort of watching the clock. I didn’t set this little

timer here. Do you want to respond to that now? That would be

terrific.

Ms. ZOON. One thing I would like to ensure the committee is 100

percent of the blood is regulated. That 10 percent of the blood supply which is supplied by registered blood banks in lieu of the 90

percent that’s under licensed banks is regulated by FDA. They are

required to maintain error and accident reports in their blood

banks, and those are inspected when the FDA goes in there. Their

submission of the reports to the FDA is voluntary, but their need

to follow GMPs and establish error and accident reports and follow

up on those error and accidents is part of our requirement.

Mr. UPTON. My point is, though, the inspections may lapse for

as long as 20 or 24 months before someone actually comes by to

sort of leaf through the material. Though the definition is we’d like

you to report it today when you have an accident, in fact that

doesn’t happen.

Ms. ZOON. And we agree with the committee, and it is being

changed in the proposed rule to have those voluntary reports mandated, but if there are problems in a facility, our inspectors will follow up more frequently than the 1 or 2 years, depending on the nature of the violations in the blood bank.

Mr. UPTON. But, see, one of the points I would like to make is

here we have a problem that’s been identified and you admit is a

problem, and we’d like to change it. Why is it that it takes years

to get even that part of it in place? What would be the problem of

just promulgating a final rule that just deals with that, which then

gives us all a little breathing room in terms of the safety of the

blood supply?

Ms. ZOON. Sir, we did propose the rule which includes the very

blood banks that you have——

Mr. UPTON. I know that it is proposed, but it’s not final.

Ms. ZOON. And the FDA has gotten the comments back. We had

97 comments back on the proposed rule, and many of these comments have been reviewed, categorized, and definitely we are moving forward on this rule. And clearly under Dr. Satcher’s leaderVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00076 Fmt 6601 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
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ship, we will move as expeditiously as possible to finalize this rule,

again, being mindful of the PHS Blood Advisory Committee. But

one thing I want to assure the committee, and this is very important, that error and accidents are just a very small part of the surveillance procedures that we use for blood banks. We have—as I

mentioned, there are not only error and accidents. We have adverse

reports. We also have fatality reports, and I think this is very important because this requires the institutions to report to the agency immediately and then follow it up with a report within 7 days,

and that is for the fatalities.

In addition, we get annual reports. If there are medical device reports, they are also reported to the agency. In addition, we have

guidances, inspection programs and recalls that we use as part of

our compliance activities to ensure at least that this oversight of

the blood safety program is dealt with, and while we recognize the

importance of error and accidents as part of that, it is part of the

bigger picture of the FDA surveillance of this system. And we treat

this very seriously because we believe this is an important area of

one of the five layers of blood safety.

Mr. UPTON. I would just like to say, I know that I am beyond

my 5 minutes and I apologize to my friend and colleague Mr. Burr.

But as I think about things, 1997 is a while ago, and to have only

97—I used to work at OMB, and I know what comments look like—

and to have only 97 comments come in is not an inordinate number

that someone can’t begin to look through, even almost one a month,

to try and get the darn thing done. To wait until 2001, I just think

one death is too many. I would hate to welcome that family and

say, if those regulations had only been in place like it was proposed, you know, years ago, we could have saved. I mean, it’s just

not acceptable. I don’t know if you’re able to do this, but can you

share with this committee the 97 comments?

Ms. ZOON. Yes, yes.

Mr. UPTON. Can I get copies of the 97? I’ll look through them myself.

Ms. ZOON. Yes.

Mr. UPTON. I look forward to doing that, but I don’t think it will

take years to finish that, particularly when I know that one of the

top priorities of the Commissioner is blood safety. I mean, it doesn’t

seem like we’re getting there—it’s not right. The priority may not

be there even though she is well-intended in stating such. I mean,

we’re just not seeing the results that we really ought to have. It’s

because of that stack of frustration that the chairman and others

are looking at. Maybe we ought to transfer the authority to someone that we know is responsible and thoughtful and courageous

and a good spokesperson in making sure that the job gets done.

Mr. SATCHER. As we speak, I take responsibility because in the

Department I am responsible for the blood safety community. That

includes FDA and NIH and CDC, and I have discussed this with

Commissioner Henney, and we are going to move forward expeditiously. We are going to give time——

Mr. UPTON. Well, surprise us. Okay.

Mr. Burr.

Mr. BURR. I thank you, Mr. Chairman.

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Dr. Zoon, if you would just stay at the table, and I thank you for

being here. Few people do I hold in as high a regard at the FDA

as I do you, and I thank you.

Just for the record let me say, Mr. Chairman, that if my memory

serves me correctly, the time that it took to go from proposed to

final rule on tobacco was 1 year with 1,000 comments. So clearly

when an agency is focused on completion, I think that significant

increases can be made in how expeditious we move from proposed

to final.

Let me say that it’s refreshing, Dr. Satcher, to hear you hold off

and to say, I am going to wait for the advisory panel. Most people

fold and go ahead and give the answer prior to getting the recommendation, and I commend you for doing it because that’s the

reason we have advisory panels, but they’re overlooked in many

cases.

I thought, as Fred talked about blood donations, about my last

one. It was a very tough process to go through. It was lengthy. The

process time seemed to be doubled, if not tripled. There were questions that I had no clue as to why they asked them, and there were

stations that I had to stop at that really did give me the impression

that a bureaucrat set the system up versus somebody who’s in the

business of blood collection, and I think that was exacerbated by

the fact that when I asked the individuals why they were there,

they couldn’t answer me. So I commend you on the efforts to

streamline the process because I think that we’re always limited in

the potential pool. That pool is one that fluctuates up and down in

the frequency of their donations, and I think right now we’re

trending in a direction, myself included, where the 55-day period

which I usually aspire to religiously has slipped and slipped and

slipped because of the time that’s needed to drop by.

Let me ask you a few questions relative to the blood collection.

I think most banks have expressed increased difficulty with their

collections. Do you believe it’s today as easy for a blood bank to

take one of the mobile units up to a factory, and collect blood as

it was prior to our efforts?

Mr. SATCHER. That’s a tough question. One of the reasons the

blood supply is as safe as it is is that we have had to make the

process tough in some ways, but I still believe, based on my own

personal experience with donating blood, that it is fairly easy to

collect blood. I think we have to look at that donor satisfaction

issue, and I listed that as one of the five areas that we’re going to

be looking at. I believe that we can improve rather than just leave

it like that on what we’re doing now because I don’t know if we

have done what I would call the sort of quality-assurance-type

strategies that we need to do to really make this process as efficient as possible.

Mr. BURR. How much will technology play a role in our ability

to expedite that process and to raise the assurance of a clean blood

system in the next several years?

Mr. SATCHER. Well, you know, obviously, as I mentioned, technology will play a role, no question about it. The nucleic acid testing will certainly mean that some of the donors that we now either

say no to or defer, we can really, really test the blood and know

fairly comfortably that it is safe. So technology will continue to play

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a major role, but also in just a repetitive way in which we’re able

to assess it.

I mean, just to reflect on hepatitis C, we first discovered this

virus in this country in 1988, and around July 1992, June, July,

we had a screening test that allowed us to really adequately screen

the blood for hepatitis C. The difference in term—and those are the

figures that I gave you about the risk of 1 in 100,000 versus a risk

of 1 in 200 of receiving hepatitis C through a blood transfusion.

Technology is critical in this area. It is the area where we have to

continue to invest in improving technology, but also improving the

technology of the process of blood donation.

Mr. BURR. Now, nucleic acid is still an investigational drug; it

has not gone through approval?

Mr. SATCHER. Right.

Mr. BURR. Let me ask you about another one, Dr. Zoon. Abbott

Labs prism blood screening analyzer. It came before the FDA in a

510K in October 1997. It took 18 months to get that final 510K

clearance. Now, there’s a Federal statute under the FDA Modernization Act. We didn’t meet it in this particular case, and I am

not asking for specifics about this application. If I did that, I’d do

it privately. But I guess my question to you is, how much better

are we doing? Where are the priorities as it relates to how new

technology expedites the process, and gives us a higher degree of

assurance? We did it with nucleic acid, but not with this. What’s

the process we go through?

Ms. ZOON. As you say, sir, the FDA Modernization Act had a

number of provisions in it that the agency is currently implementing. CBER has a number of devices related to biological products, and those that are involved in blood screening lie under

CBER’s purview. We recognize the importance of high performance

in this area, and, in fact, in the past 9 months we have issued a

device action plan at the Center for Biologics to deal with performance issues, inspections, communication and a variety of areas to

affect devices, so that we are looking forward to improvements in

this area and performance overall by focusing on this more.

Mr. BURR. What is the percentage of applications that actually

fall within that 90-day statute; do you know?

Ms. ZOON. Well, there’s a number of—there are—the Center for

Devices and Radiological Health have by far the large majority of

510Ks. I don’t have those numbers right here in my head, but we’d

be happy to get back to you.

Mr. BURR. Get back with me if mine are wrong, and according

to recently released data, the FDA’s Division of Blood Applications

took first action within 90 days as required by the statute and the

FAD’s own performance goals in 36 percent of the cases. Now, if,

in fact, my information is wrong, please let me know, but I would

tell you that if you are looking for an area that we can have an

immediate impact, let us get closer to 100 than zero as it relates

to that statutory deadline of action on applications.

Dr. Satcher, let me go somewhere that probably isn’t directly relevant to this hearing, but I think that it’s important. There is a

huge debate that will continue for some time, and possibly action

by HHS, as it relates to medical privacy. I’ve looked at your plan

on the hepatitis C look-back. The way I envision some of the proVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00079 Fmt 6601 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
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posals as it relates to medical privacy, some go as far as an optin, opt-out on a patient’s basis as far as the sharing of their data.

Opt-out, it can go nowhere. It can be used for nothing. It cannot

go into research for the purposes of drug and device development.

But more importantly, when you lose the ability to have a key to

identify the individual, how could that affect the public health of

this country, and what would it do specifically to the ability to look

back, whether it’s hepatitis C, or if it’s something 10 years from

now, or all of a sudden there is a need to address a public health

issue with individuals?

Mr. SATCHER. I think it’s a critical issue, let me just put it that

way. I think balancing patients’ rights to privacy with the public

health needs for research and investigation is one of the critical

issues that we face. Obviously, it relates even to HIV name reporting which is being debated right now. For a lot of reasons you could

argue that we need to treat HIV the same as we’ve treated other

sexually transmitted diseases.

I think we have not in this country arrived at a point that we

have assured the population that there is not a risk of being identified. We have been through a difficult period, you know, Ricky Ray

and other things I can remind you of, where people have actually

suffered because of identity. So we’re trying to overcome that.

We’re trying to overcome that fear, that distrust. We’re trying to

find ways to assure people that we can protect them while at the

same time carrying out the public health needs to take control of

an infectious disease epidemic like hepatitis C or HIV.

Mr. BURR. Do you agree that Congress could go so far in the privacy effort that they could eliminate the ability for you as a Surgeon General, or CDC, or for anybody whose core function it is, to

address the public health of the American people, that we would

have an inability to look back, an inability, once technology allows

us to find a genetic trait that may or may not be treatable, but we

owe it to look back and notify the individual? Could we go so far

that we couldn’t have the ability to do that?

Mr. SATCHER. We could, but I think we have this need and this

obligation to also protect the rights of people from abuse, and

whether that occurs on a Federal level or State level or local level.

So I think we’re trying to balance these, and I think that does require us to do some things that are not necessarily optimal at the

time in terms of the public health needs, but I think we always

have to keep the public health needs of the Nation in the forefront

while trying also to protect individuals.

Mr. BURR. I would agree with you totally.

Let me ask you relative to the technology infusion into this specific area of blood safety, if we went too far on the privacy issue,

what does that do to the marketplace as it relates to what effort

companies are going to make to develop technological advances in

blood detection or any other areas?

Mr. SATCHER. Well, obviously, it could affect the market in terms

of depending on what specifically we did.

Mr. BURR. It’s not a trick question. I am not trying to nail you

on anything. I’m just trying to make everybody understand this is

a much bigger issue.

78

Mr. SATCHER. It’s a very important issue, there’s no question

about it, and I think the bottom line is—and it’s not always easy

to get to that bottom line—is that we’ve got to find a way to balance the public health needs on the one hand and the thing that

we value so much in this country, the rights of individuals and the

protection of individuals from abuse.

Mr. BURR. If you couldn’t identify the individuals who were exposed to mad cow disease, to follow them for whatever period of

time we need to, to secure their safety, how much of a health risk

is that in the U.S., if we don’t know that it can be transmitted?

Mr. SATCHER. I don’t know the answer to that question

because——

Mr. BURR. Nor do I.

Mr. SATCHER. As I have already said, if we don’t even know yet

whether or not it is possible for a new variant CJD to be transmitted in blood transfusions, we certainly don’t know the risk that

individuals provide to others in society. So we are still studying

that issue very carefully. So I can’t answer your question.

Mr. BURR. If it could be transmitted, though, it would be important that we would know who was exposed, wouldn’t it?

Mr. SATCHER. Yeah, but also you have to understand that we—

what we need to be able to do is to detect any risk to the public

that is in the blood supply. Many times the individual him or herself will not know that they have the risk in their blood. So our

concern right now is our own ability to detect as early as possible

any threat to the safety of the blood supply, and that’s our major

struggle.

Mr. BURR. You have mentioned nucleic acid several times. How

available is it to blood centers around the country?

Ms. ZOON. While it’s under investigational development, it has

broad use—many blood centers have and institutions have taken it

on under the clinical investigation phase to get experience with it

and have been involved in these clinical trials. So it has a very

broad base. I can’t give you the percentage of implementation of

NAT testing, or nucleic acid testing, for blood. It varies based on

the agent. HCV and HIV are the two primary agents, and we could

get you the exact numbers of how the percentage of what blood

banks are using the NAT test for HCV and the NAT test for HIV.

Mr. BURR. What I conclude from that answer is that if we looked

at it on a percentage basis, it would be a very small percentage of

the blood banks.

Ms. ZOON. No. Actually Dr. Epstein just handed me 92 to 98 percent of whole blood is already NAT-tested for HCV.

Mr. BURR. Okay. Mr. Chairman, I thank you for the time that

you were able to give me and would encourage you to give up on

Michigan this year. They have no prayer.

Mr. UPTON. I just wished we played North Carolina and North

Carolina State or any other, Wake Forest, it doesn’t matter. The

gentleman’s time has expired.

Mr. BURR. Mr. Chairman, can I make one correction? My crack

staff behind me informed me that I needed to correct the record as

it related to the comments on tobacco. There were 7,000 comments

on tobacco, which probably makes my point even a little heavier.

Mr. UPTON. But the problem is 6,000 of them were yours.

79

Okay. I have a question with regard to the NAT testing. When

I donate blood next week, I am going to ask about the NAT test.

My sense is that it will be NAT-tested. Tell me exactly what happens. You said, what, 90 percent of the blood collected today is

NAT-tested, nucleic-acid-tested?

Ms. ZOON. Yes. It’s investigational, so these are being studied in

92 to 98 percent of whole blood, and this is for hepatitis C virus,

so I just want to make sure that’s clear.

Mr. UPTON. Will they test it right there at the site?

Ms. ZOON. Some blood banks will have their own laboratory. Others have centralized laboratories. I believe ARC has centralized

laboratory testing.

Mr. UPTON. Okay. Part of the testimony that we heard in September was the concern that at some point next year, the trend

lines will cross, and we will perhaps be in a real crisis as the number of donors and blood units has been on the decline, and the need

for blood is increasing. And particularly with the new test that’s

now in place or the new question that if you have been in the UK

from 1980 to 1996 for a period of more than 6 months during that

period, you’re asked to come back some other date, who knows

when, but because of that decline, which is probably about as much

as 2.2 percent, as I recall, that, in fact, the real comfort level for

the blood supply, particularly in a number of regions around the

country, could be in desperate need. Now, would you agree with

that? Is your sense along the same lines?

Mr. SATCHER. It’s a difficult question, but let me just say that

there are several things happening at the same time, and the same

day on which, of course, we acted on that proposal, which we will

monitor every 6 months, we’ve also taken action relative to

hemochromatosis. What impact will this have on the blood supply?

It could increase the blood supply from 300,000 units to 3 million

units of blood a year. And then the other things that we are doing

in terms of enhancing the blood supply—and on the other end, I

think there’s also some ways to be more efficient with how we use

blood that we collect, and so all of these things are happening at

the same time.

We’re going to be vigorous in our attempts to make sure that the

blood supply continues to be adequate and it’s enhanced, especially

in the areas of plasma donation.

Mr. UPTON. I was a little surprised when the NBDRC testified,

and I was a little surprised at that hearing that there was not a

system now in place, at least monitored by the FDA or anybody

else, that actually measures the units of blood on a monthly basis

that are collected, and in fact, your statement as part of the record

was that we are going to get data—and the NBDRC indicated they

would share the data with this committee as well. I hope we don’t

have to pay $300,000 for it.

Mr. SATCHER. You’ve already paid $300,000.

Mr. UPTON. Yeah, maybe we did. But I was surprised, I guess,

that we’ve spent a lot of money. Over the last couple of decades

looking at some of these trend lines, and yet there is not one thing

that has been collected at least on a national basis until beginning

of next year. What’s your comment with regard to that?

80

Ms. ZOON. Well, my only comment is that at this point in time,

we recognize the need right now, especially with the current concerns regarding blood supply, to make sure that we have a vigorous

program in the Department to look at this, and, in fact, this study

is actually being funded by the National Heart, Lung, and Blood

Institute and will be sharing the data with the FDA and the CDC

and working with Dr. Satcher on the Blood Safety Committee to

make sure that we use this information wisely to ensure an adequate blood supply.

So we have not done this, to my knowledge, on a monthly basis

or contracted this information, but we have—there have been other

studies looking at blood donations, and that will be important additional information, as we go forward, to look at what initiatives we

may need to follow.

Mr. SATCHER. And I think there is—we think that there is a lot

of potential in going back to donors like yourself, and I don’t know

how often you donate, but there are a lot of people who take very

seriously the donation of blood. Many of them only donate once a

year, and so we can be much more aggressive in terms of trying

to encourage people to donate more, but also that pool of people

who are eligible who don’t donate, so we’re going to be working in

all of these areas.

Mr. UPTON. Well, that second category is going to be considerably

larger than the first one, I imagine. Maybe we just ought to get for

happenstance a show of hands in this room, how many folks here

have donated blood ever, raise your hand. I’m pleasantly surprised.

And how many people have donated in the last year? My hand is

down, too, but it will change next week.

Mr. SATCHER. That’s an important question, and how do we get

to the 60 percent. You see, I didn’t raise my hand for the last year.

Mr. UPTON. Because the camera was on you.

Mr. SATCHER. No, no, because I travel. In my position, I travel

a lot, and there are a lot of places where we travel that you’re not

eligible——

Mr. UPTON. We’d like you travel to Michigan. You can do it with

me on Monday.

Mr. SATCHER. No. I travel to places where if you travel there,

you’re not eligible to donate blood, sometimes for 3 years, and

that’s one of the ways we protect the safety of the blood supply.

Mr. UPTON. What are some of those countries? I will fill out the

questionnaire when I am there on Monday, but what countries

are——

Mr. SATCHER. Places that are high risk for malaria for example,

sub-Saharan Africa, Southeast Asia, places where countries are

still struggling with malaria, and hopefully we’re going to solve

that problem because the World Health Organization has made a

real commitment to roll back malaria. But these are maybe 1 billion people in the world who are now at risk for malaria because

of where they live. Generally, they are places where poverty is a

major factor in terms of setting up the systems to prevent the

spread of malaria and diseases like that. So if you travel to those

areas, in order to optimally protect the safety of the blood supply,

we ask people—we don’t allow people to donate for quite a while.

81

Mr. UPTON. That’s certainly a valid excuse. You don’t need to

submit anything in writing on that.

One of the things you indicated in your statement was that the

NIH has been authorized to spend $1.8 million to enhance and improve the number of folks that donate blood. Has that ever been

done before? Has NIH been given that authority before? Have there

been times that they have had——

Mr. SATCHER. They have a priority. What I don’t know is if they

have ever done it before. I don’t think so.

Mr. UPTON. Do you know if they have done that before?

Mr. SATCHER. It’s new. As far—I’m always hesitant to say it’s

never been done before.

Mr. UPTON. Especially under oath.

Mr. SATCHER. Yeah, that’s right. But as far as we know, it has

not been done before.

Mr. UPTON. And do you know when their report is going to be

due or submitted? Do you know when that will be? It won’t be in

time for your January meeting, will it, or it will be? Good, I see

a nod.

Ms. ZOON. The money or the funding for the NBDRC is committed to produce monthly data is starting in October. So we

should have our first report in November.

Mr. SATCHER. We don’t know how much information we will have

by then, so when we say monthly reports, some of those will be just

process reports.

Mr. UPTON. I know that we asked for the same data, as I indicated a little earlier, so we are looking forward to seeing those

trend lines particularly early next year when Congress comes back,

after we finish at some point this year as well.

Well, I appreciate you both coming up today, and we may have

additional questions that other members of the panel may wish to

submit. If you could respond to those in a timely basis, that would

be terrific.

We wish you well on your meeting. If you would like to take this

gavel and rap some knuckles, it’s yours, and you don’t need——

Mr. SATCHER. We really appreciate your holding this hearing. I

think it will help to move us forward. We appreciate your attention.

Mr. UPTON. We will be following it with rapt attention, I can assure you. Thank you very much. You are excused. Thank you.

[Whereupon, at 12:10 p.m., the subcommittee was adjourned.]

[Additional material submitted for the record follows:]

U.S. HOUSE OF REPRESENTATIVES

COMMITTEE ON COMMERCE

October 21, 1999

The Honorable DAVID SATCHER

Assistant Secretary for Health and Surgeon General

Department of Health and Human Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

DEAR DR. SATCHER: Thank you for your testimony on October 6, 1999 concerning

the safety and availability of the U.S. blood supply. I appreciate your commitment

and hard work for maintaining the safety and availability of the nation’s blood supply. As a follow-up to the hearing, I would appreciate your response to a question

concerning the Hepatitis C education program.

82

Hepatitis C virus (HCV) is the most common cause of post-transfusion hepatitis.

Overall, HCV is responsible for 15 to 20 percent of all cases of acute hepatitis and

is the most common cause of chronic liver disease. Prior to 1992, blood was not routinely tested for HCV prior to transfusion. FDA regulations now require testing of

all blood for HCV. HCV has become a major public health concern, and public

health agencies have engaged in an active search to identify patients exposed to

HCV-infected blood. In August 1997, the Department of Health and Human Services

recommended a look-back and public education campaign.

On March 5, 1998, you announced the HCV look back and education plan. You

testified that HHS has ‘‘established a comprehensive plan to address this significant

public health problem. It is our intention to reach effectively as many people at risk

as we can.’’ My understanding is that rather than running a national campaign informing people at risk about the need to get tested for Hepatitis C, the Centers for

Disease Control (CDC) is pilot testing transit ads in the insides of buses and other

public transportation only in the Washington, D.C. area and Chicago, September 1-

October 31, 1999. This month, the Michigan Hepatitis C Coalition is kicking off a

statewide education campaign, Hepatitis C Awareness Month. I understand as

many as 168,000 Michigan residents already may be infected with Hepatitis C.

These residents and many other Americans would benefit from the Hepatitis C public education program.

Given your commitment to a comprehensive campaign, when will the Hepatitis C

public education program run nationally? In addition to providing a target date,

please explain what information the CDC expects to gain from the pilot program

and how this could affect the design and timing of the public education program.

I would appreciate your response by November 12, 1999, for purposes of completing the hearing record. Thank you for your assistance. If you have any questions, please contact Alan Slobodin of the Committee staff at (202) 225-2927.

Sincerely,

FRED UPTON, Chairman

Subcommittee on Oversight and Investigations

cc: The Honorable Tom Bliley, Chairman

The Honorable John D. Dingell, Ranking Member

The Honorable Ron Klink, Ranking Member Subcommittee on Oversight and Investigations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

ASSISTANT SECRETARY FOR HEALTH

SURGEON GENERAL

November 18, 1999

The Honorable FRED UPTON

Subcommittee on Oversight and Investigation

Committee on Commerce

Room 2125, Rayburn House Office Building

Washington, D.C. 20515-6115

DEAR MR. UPTON: I am happy to respond to your inquiry of October 21, 1999 regarding the Department of Health and Human Services’ Hepatitis C Public Education Program.

This program, which I announced in Congressional testimony on March 5, 1998,

has several components. These include education of healthcare professionals, education of the general public, and education of those at increased risk of hepatitis

C virus (HCV) infection.

Our efforts to educate healthcare professionals began in 1997. Prior to this time,

many physicians had little knowledge of HCV infection, and there were differences

of opinion among experts about how best to manage this condition. For this reason,

a Consensus Development Conference was convened by the National Institutes of

Health (NIH) in March 1997. Following this Conference, the NIH issued Management of Hepatitis C, based on evidence presented at the Consensus Conference. In

November 1997, The Centers for Disease Control and Prevention (CDC), in collaboration with the Hepatitis Foundation International, produced an interactive satellite

conference on HCV infection for primary care physicians, Hepatitis C: Diagnosis,

Clinical Management, Prevention. The audiotape and other materials from this teleconference were mailed to 250,000 primary care physicians (family practitioners, internists, pediatricians, surgeons, and obstetrician-gynecologists) during the summer

of 1998.

In July 1998, CDC convened a meeting of consultants to develop updated recommendations for the prevention and control of HCV infection and HCV-related

chronic liver disease, including identification of persons at risk because of prior

blood transfusion. In October 1998, Recommendations for Prevention and Control of

83

Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Liver Disease was published as a supplement to Morbidity and Mortality Weekly Report. This supplement

was mailed to both primary and specialty care physicians throughout the country.

These publications provided a framework for developing health education messages

concerning HCV screening, counseling, and prevention to the public.

Initial public education activities begin in 1997 with the development of health

communications materials on hepatitis C, risk factors for HCV infection, and HCV

testing. These materials were developed by the CDC and the American Liver Foundation, the Hepatitis Foundation International, and the National Association of City

and County Health Officials, with support from cooperative agreements funded by

CDC. In early 1998, CDC began routine updates of information about HCV prevention, testing, and control on its website and on its Hepatitis Information Line.

Development of national public education activities to encourage HCV testing of

persons at risk because of prior blood transfusion began in February 1999. Contracts were funded for the development of public advertising and patient information brochures. Focus groups of individuals who had received transfusions were used

in the development of these materials. On May 5, 1999, CDC hosted a press briefing

about HCV at the National Press Club; this event was attended by over 100 media

representatives. Public transit advertisements based on these materials were run in

Washington, D.C. and Chicago in September and October, 1999, at a cost of $70,000.

The impact of this pilot program on the number of inquiries to the CDC Hepatitis

Information Line, a manned hepatitis C hotline, and to the CDC hepatitis web site

is currently being analyzed.

CDC plans to expand this effort nationwide by making these materials available

to national voluntary health organizations for distribution. In addition, through the

CDC Foundation, partnerships are being developed for cosponsorship of an expanded national public advertising campaign that is to begin in early 2000.

Also in early 2000, CDC plans to bring together national professional and voluntary health organizations whose patients have a high likelihood of having received a transfusion before July 1992 (e.g., premature infants, persons who had

heart surgery, women who had caesarean sections). The purpose of this meeting is

to encourage these organizations to make their membership aware of the need for

HCV testing for certain transfusion recipients and to share the materials developed

by CDC.

I would be happy to answer any additional questions you may have.

Sincerely yours,

DAVID SATCHER, M.D., Ph.D.

Assistant Secretary for Health and Surgeon General

U.S. HOUSE OF REPRESENTATIVES

COMMITTEE ON COMMERCE

November 1, 1999

The Honorable DAVID SATCHER

Assistant Secretary for Health and Surgeon General

Department of Health and Human Services

200 Independence Avenue, S.W.

Washington, D.C. 20201

DEAR DR. SATCHER: Thank you for your testimony on October 6, 1999 concerning

the safety and availability of the U.S. blood supply. As a follow-up to the hearing,

I would appreciate your responses to the following questions:

1. The FDA, NIH, and U.S. Army held a September 27-28, 1999 Workshop on

‘‘Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Cell

Substitutes.’’ Given the potential shortages which could occur—either regionally or

nationally—in the blood supply, some observers believe that oxygen therapeutics

could provide a safe, effective, and readily available alternative to blood donations.

What specific actions and timelines for implementation resulted from this Workshop?

2. The General Accounting Office (GAO) indicated that ‘‘one alternative being explored for handling issues of blood shortages and blood safety is the development

of blood substitutes.’’ The goal is to develop substitutes for red blood cells that are

safe, do not require cross-matching or typing, have a longer shelf-life, are readily

available in large quantities, and deliver oxygen therapeutically and quickly to tissues and organs. Given the potential of these alternative agents, what criteria

would be considered for expedited review of their use for specific applications which

could relieve shortages, either regionally or nationally, if and when they occur? If

the criteria were satisfied, what steps would be taken to expedite review?

84

3. As indicated by the GAO, the U.S. imports approximately 2% of its blood supply. Given the potential for shortages in the U.S. supply, how can HHS assure that

any increased imports of blood will have the same level of quality—particularly considering donor exclusions like the ban on individuals who have resided in the U.K.

for a cumulative 6 months or more between 1980 and 1996?

I would appreciate your response by November 15, 1999, for purposes of completing the hearing record. Thank you for your assistance. If you have any questions, please contact Alan Slobodin of the Committee staff at (202) 225-2927.

Sincerely,

FRED UPTON, Chairman

Subcommittee on Oversight and Investigations

cc: The Honorable Tom Bliley, Chairman

The Honorable John D. Dingell, Ranking Member

The Honorable Ron Klink, Ranking Member Subcommittee on Oversight and Investigations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

ASSISTANT SECRETARY FOR HEALTH

SURGEON GENERAL

November 18, 1999

The Honorable FRED UPTON

Subcommittee on Oversight and Investigation

Committee on Commerce

Room 2125, Rayburn House Office Building

Washington, D.C. 20515-6115

DEAR CONGRESSMAN UPTON: I am writing in response to your letter to me dated

November 1, 1999 concerning the development of oxygen-carrying therapeutics as

possible blood substitutes in light of possible blood shortages. At this time the approval of any such product is not imminent, since no candidate product has yet been

shown to be safe and effective for a well-defined clinical indication. By way of clarification, it needs to be understood that oxygen-carrying therapeutics may not actually substitute for use of blood products. For example, products with a short duration of action in the body may prove useful as volume replacement solutions, but

only as a temporary therapy until blood is available. Also, even if oxygen-carrying

therapeutics can substitute for use of some blood components such as red cells, they

cannot be expected to substitute for use of all blood components due to the complex

nature or blood.

FDA has been very active in its interactions with the industry that is developing

oxygen-carrying therapeutics both through public discussions and regular meetings

at the request of product sponsors. At these meetings, sponsors are given the opportunity to express their views and discuss their data. FDA understands industry’s

concerns about the often-difficult clinical studies that are necessary to validate these

products. At the same time, FDA is appropriately concerned about the need for careful studies to establish the safety of oxygen-carrying therapeutics. As you know,

there have been enormous strides made in recent years to make the United States

blood supply highly safe. If a product is to be used as a substitute for blood, there

should be assurance that it is at least as safe as blood. Studies to substantiate safety comparable to blood products necessarily are large, difficult and expensive.

The following remarks address your specific questions as numbered in your letter:

1. You asked what specific actions and timelines for implementation resulted from

FDA’s recent ‘‘Workshop on Criteria for Safety and Efficacy Evaluation of Oxygen

Therapeutics as Red Cell Substitutes.’’ As a result of the valuable discussions from

both industry representatives and academic researchers who are prominent in the

field, FDA will develop an industry guidance document on the design of clinical

trials to validate indications for oxygen-carrying therapeutics. According to established ‘‘Good Guidance Practices’’ the guidance will be distributed initially as a draft

for comment, and then finalized for implementation after review of public comments. In this policy document FDA will address the various possible indications for

these products and provide guidance an the data needed to validate different claims.

FDA’s Center for Biologics Evaluation and Research expects to develop the draft

guidance by the end of Spring 2000. In the interim, FDA will continue to make its

current thinking known through public statements and in meetings with product

sponsors.

2. You have asked what criteria would be considered for expedited review of these

products. FDA is committed to a rapid approval of any product that addresses a significant unmet medical need such as novel use in a serious or life-threatening condition. Under the FDA Modernization Act of 1997, criteria for fast track approval were

well defined. In particular, accelerated marketing approval can be granted to appliVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00087 Fmt 6601 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
85

cable drugs that have an effect on a surrogate marker that is reasonably likely to

predict clinical benefit, As yet, such surrogate markers have not been established

for validation of oxygen-carrying therapeutics. Nevertheless, FDA is working cooperatively with product sponsors to clarify the requirements for validation and thereby facilitate product development. For some indications, e.g., trauma, the endpoint

of mortality is of overwhelming interest and it is possible that a surrogate may not

be useful.

3. You have asked how DHHS can assure that any increased importation of blood

will maintain the U.S. standards for quality. As you know, FDA allows blood products to be imported under certain conditions. However, the blood that is imported

for distribution in the U.S. is collected and processed only in FDA-licensed facilities.

As such, the facilities are required to meet all of our standards including those for

donor suitability, product testing, and good manufacturing practice. To insure compliance, U.S.-licensed foreign facilities are inspected according to the same standards as facilities located within our borders. Blood products that are not collected

in licensed facilities may be imported for further processing solely for export under

appropriate circumstances and conditions as determined by FDA. Such imported

blood cannot be distributed for human use in the U.S., and the final manufactured

product can only be exported. Therefore, the safety or availability of blood products

in the U.S. would not be affected.

I hope that these remarks adequately address your stated concerns. Please feel

free to contact this office if you have additional comments.

Sincerely yours,

DAVID SATCHER, M.D., Ph.D.

Assistant Secretary for Health and Surgeon General

DEPARTMENT OF HEALTH & HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

November 23, 1999

The Honorable FRED UPTON

Chairman

Subcommittee on Oversight and Investigations

Committee on Commerce

House of Representatives

Washington, D.C. 20515-6116

DEAR MR. CHAIRMAN: The Food and Drug Administration (FDA or Agency) appreciated the opportunity to accompany Dr. David Satcher, Assistant Secretary of

Health and Surgeon General, at the October 6 hearing to discuss the present state

of blood safety and availability. FDA appreciates and shares your concern about the

safety of the blood supply. During the October 6 hearing Dr. Kathryn C. Zoon, Director, Center for Biologics Evaluation and Research (CBER), was requested to provide written answers to several questions for the hearing record. The questions and

answers are provided below and the corrected transcript is enclosed. In addition, to

assist the Committee in its consideration of blood safety issues, a more detailed explanation of certain aspects of FDA’s blood safety program is provided.

Error and Accident Reports

FDA is committed to finalizing the proposed rule on error and accident. FDA appreciates the concern expressed by you about the lack of required error and accident

reporting for registered, but unlicensed blood banks. A more detailed explanation of

the error and accident reporting function and its applicability to blood safety is provided below for your information.

Error and accident reports are one of several safety layers FDA utilizes in monitoring the safety of the blood supply. FDA uses error and accident reports primarily

to identify systemic problems for the entire industry. Inspections are the most important tool used to monitor industry compliance. Prior to inspection, and on an ongoing basis, FDA reviews previous inspection reports, fatality reports, adverse experience reports, medical device reports, annual reports and error and accident reports. During inspection, FDA reviews these reports to determine if the firm appropriately investigated the incident and implemented corrective action.

There is, at times, a public misconception that recalls and withdrawals of products are dependent on the filing of error and accident reports to the Agency or that

such actions are somehow delayed by the classification of such reports. This is not

accurate. Blood establishments are required to take corrective actions immediately,

independent of the reporting process. Blood establishments are ultimately responsible for the products they distribute. FDA monitors industry compliance with

86

standards but cannot function as the quality assurance unit for each manufacturer.

It is the manufacturer’s responsibility to comply with rigorous standards that are

necessary to protect the blood supply. The error and accident reports constitute one

facet of the system of overlapping surveillance. Primarily, these serve as one source

of information on industry performance. The most critical problems that result in

a fatality are brought to FDA’s attention in a short time and investigated. As noted

at the hearing, fatalities are required to be reported to FDA within seven days (21

CFR § 606.170(b)).

The requirement for blood establishments to file error and accident reports cannot

itself provide an assurance that blood will be safe. The majority of errors or accidents are not life threatening and are detected and reported retrospectively during

quality assurance activities or audits (21 C.F.R. § 211.180 (e) and 21 C.F.R. § 820.22

requires that audits be performed on at least an annual basis). The detection of errors and accidents allows firms to investigate and correct any deficiency in the system so that future errors can be prevented. On an industry wide basis, the actual

reporting to FDA of errors and accidents enhances FDA’s oversight. These reports

assist the Agency to identify the need to develop new policy, to revise existing policy, to provide training to industry and FDA inspection personnel and to revise compliance programs as appropriate.

Licensed Blood Banks and Unlicensed Blood Banks (Registered)

During the hearing on October 6 and the two other hearings held on blood safety

and availability, licensed and unlicensed blood banks were discussed. To assist the

Committee, the following information may be helpful.

All blood banks are registered with FDA and are assigned registration numbers.

The Public Health Service Act requires a firm to have a license in order to introduce

biological products such as blood and blood products into interstate commerce. This

is in addition to being registered with FDA. Although there are two types of facilities, there is no difference in the inspectional coverage or requirements to follow

current good manufacturing practices (cGMPs) for licensed versus unlicensed blood

banks. Routinely, all blood banks are inspected once every two years. Inspectional

frequency of individual blood banks is increased, however, when there is a recent

violative history.

Transfusion Services

A number of questions were also raised during the hearing concerning transfusion

services and we wanted to provide additional information for the Committee. Transfusion services routinely perform blood typing and crossmatching. Transfusion services do not collect blood or manufacture components. While the majority of transfusion services are inspected by the Health Care Financing Administration (HCFA),

some transfusion services that perform some further manufacturing of blood products such as washing, freezing, deglycerolyzing, or irradiating are inspected by FDA.

Because the Veteran’s Affairs and military transfusion services are not regulated by

HCFA, these facilities are also inspected by FDA.

Transfusion services that are inspected by HCFA are usually small hospital or

outpatient center blood banks that only perform blood typing, crossmatching and

issue blood. As of November 1, 1999, the number of transfusion services, which do

not collect blood or manufacture blood components, and are regulated by HCFA is

about 5000. FDA’s and HCFA’s coverage and responsibilities for these facilities is

discussed in the 1980 Memorandum of Understanding between FDA and HCFA, a

copy of which is enclosed as Tab A.

Fatality Reports

In the hearings held by the Committee there was uncertainty concerning the

number and types of fatalities. As noted at the hearing, fatalities are required to

be reported to FDA within seven days (21 CFR § 606.170(b)). We are happy to provide the following information for clarification.

The total number of fatalities reported to FDA in the last 3 years is:

FY 1999 ................................................................................................................................................................................ 64

FY 1998 ................................................................................................................................................................................ 85

January to September 1997 ................................................................................................................................................. 57

Of these fatalities, the following numbers and percentages refer to fatalities that

occurred as a result of an individual receiving the wrong unit of blood:

FY 1999 ...................................................................................................................................................................... 7 (11%)

FY 1998 ...................................................................................................................................................................... 11 (13%)

January to September 1997 ....................................................................................................................................... 14 (25%)

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These errors have been attributed to either laboratory staff or other persons outside the blood bank (usually nurses and medical staff in the OR, ER, ICU, or patient

units), in the following numbers:

Lab Other

FY 1999 ................................................................................................................................................................... 4 3

FY 1998 ................................................................................................................................................................... 6 5

January-September 1997 ......................................................................................................................................... 8 6

Please note that CBER changed its reporting interval in October 1997 to reflect the fiscal year used throughout the Government.

A small number of the laboratory errors are caused by laboratory personnel, usually phlebotomists, who do not work directly in the blood bank but who obtain blood

specimens from patients for the blood bank to use in crossmatching. Errors caused

by nurses and medical staff outside the blood bank can occur when a unit that has

been correctly processed and labeled is given to the wrong patient. As mentioned

above, please note that the number of fatalities caused by patients receiving the

wrong unit of blood has decreased over the past 3 years.

Questions/Answers from October 6 Hearing

Question: (Chairman Fred Upton) Could FDA provide the 97 docket comments received commenting on the 1997 proposed Error and Accident Rule?

FDA has provided these comments previously to the Committee. All of the docket

comments were provided electronically to Mr. Alan Slobodin, Committee Counsel,

over several days, from September 26 through September 29.

Question: (Mr. Richard Burr) According to his information, only 36% of device applications filed with CBER had a first action within the statutory deadline of 90

days.

Please find enclosed at Tab B a chart entitled, CBER’s Device Review Performance, which details FY99 and FY98 device review data for a number of categories.

CBER is committed to improving its performance in this area. As was explained by

Dr. Kathryn Zoon at the hearing, CBER has made considerable progress in improving device review times. Performance has been of concern in the past and in response to that concern, CBER held a stakeholders meeting in December 1998 specifically to discuss CBER’s review of medical devices. One result of that meeting was

the development of the CBER Device Action Plan (DAP). This DAP is provided at

Tab C. The plan also can be found on FDA’s website at www.fda.gov/cber.

The plan went into effect on April 20, 1999. Since then, CBER has received 17

device submissions. Of these 17, 11 have had a first action completed on time while

the remaining 6 submissions are pending and CBER anticipates completing the first

action within the due date.

In conjunction with the DAP, CBER also has conducted a number of activities

that relate to the implementation of the Food and Drug Administration Modernization Act device provisions. These include the following:

CBER is working along with CDRH on device standards development and guidances

for In vitro Diagnostics.

CBER established a ‘‘Device Information’’ section on its home page that includes:

The Device Action Plan

A list of medical devices regulated by CBER

Device Approval Information

FDAMA Guidances, Information on Preparation Device Marketing

Submissions, & Intercenter Agreement between CBER and CDRH

In July 1999, CBER established mechanisms to meet the time periods specified in

FDAMA for the review of applications and submissions.

CBER conducted scientific training to improve the skills of product reviewers; many

product reviewers also took courses sponsored by CDRH.

CBER and the Health Industry Manufacturers Association (HIMA) cosponsored a

Vendor’s Day for CBER staff to allow biological device manufacturers to demonstrate new biological devices and describe how they work.

A CBER sponsored public meeting and teleconference was held on November 15,

1999, with device stakeholders on the development of regulations and guidance

documents.

Question: (Mr. Richard Burr) Why did it take 18 months for the Abbott Prism

screening test to receive 510k clearance?

The original submission for this device came to FDA in October 1997, and the review was completed in November 1998. At that time, a period of 1 year for a blood

device review was not uncommon in CBER and reflected the resource limitations in

this program.

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Question: (Mr. Richard Burr) What percentage of facilities are using nucleic acid

testing (NAT) for its blood donations?

Information on implementation of NAT was provided to FDA in August and October by the American Association of Blood Banks based on a survey of blood centers

and hospitals. As of October 1999, of the blood centers that collect approximately

92% of whole blood in the United States, close to 100% were using NAT for Hepatitis C Virus (HCV) screening. As of August 1999, approximately 65%-78% of these

same centers were using NAT for HIV. Of hospitals that collect about 8% of the

blood supply in the United States, approximately 10% (51 out of 500 hospitals surveyed) were using NAT for HCV screening. These 51 hospitals account for about

90% of hospital collections, so another 7% of the blood supply was being screened

by NAT for HCV. As of August 1999, the Department of Defense (DOD) had not

yet implemented NAT testing. DOD collections represent about 1% of the blood supply. Since the test is not yet approved, all use is being conducted as part of clinical

trials for the investigational product. Part of the 8% of blood that is collected by

hospital blood banks is autologous blood, to be used by the donor only, and presents

no additional risk of infection to the donor/recipient.

We hope this information is useful and responds to your questions. We will be

glad to answer any other questions you have.

Sincerely

MELINDA PLAISIER

Associate Commissioner for Legislation

Enclosures

cc: The Honorable Ron Klink

Ranking Member

Subcommittee on Oversight and Investigations

House of Representatives

The Honorable Tom Bliley

Chairman, Committee on Commerce

House of Representatives

The Honorable John Dingell

Ranking Member

Committee on Commerce

House of Representatives

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BLOOD SAFETY AND AVAILABILITY

TUESDAY, OCTOBER 19, 1999

HOUSE OF REPRESENTATIVES,

COMMITTEE ON COMMERCE,

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,

Washington, DC.

The subcommittee met, pursuant to notice, at 9:30 a.m., in room

2322, Rayburn House Office Building, Hon. Fred Upton (chairman)

presiding.

Members present: Representatives Upton, Whitfield, Ganske,

Bryant, Bliley (ex officio), and Green.

Also present: Representative Combest.

Staff present: Alan Slobodin, majority counsel; Anthony Habib,

legislative clerk; Chris Knauer, minority counsel; and Brendan

Kelsey, minority clerk.

Mr. UPTON. Good morning. Those bells, by the way, indicate we

are going into recess for a short while. I think we are not expecting

a vote for about an hour or so.

This morning the subcommittee continues its oversight hearings

on the safety and availability of the United States blood supply. At

previous hearings we have heard from the GAO that the blood

shortage situation was overstated. Today we will hear a much different story from the blood collection side. Today’s testimony and

reports from around the country indicate that our blood supply is

below comfort level in many regions. More current information

than that reviewed by the GAO suggests overall trends threaten

the blood supply. For example, the American Red Cross will tell us

that in the last 2 years, while they have seen blood collections increase by 8 percent, blood distribution to hospitals has increased

even more, 11 percent.

In August 1999, survey of members of America’s Blood Centers

showed a 7 percent increase in demand over August 1998. The

Midwest has historically been the blood basket for the rest of the

country. I understand from America’s blood centers that some blood

centers in the Midwest that have never or rarely gone on emergency appeal went on an emergency appeal this year, 1999.

This past summer, my home State of Michigan, the American

Red Cross declared a blood alert in Michigan because of decreased

donor turnout. The southeastern Michigan region of the Red Cross

had less than 1 day’s supply of blood in its inventory.

One of the themes we will hear at this hearing is that national

leadership is needed to support national blood donations. For the

past month this subcommittee has held hearings on the safety and

availability of the blood supply. I anticipate chairing further hearVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00110 Fmt 6601 Sfmt 6601 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
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ings on blood-related issues throughout this Congress. Last week

in my home community, I donated blood and I urge others to donate blood as well. We will hear from one family today on how that

blood donation truly is the gift of life.

Without a significant effort to increase blood donations, our blood

supply will gradually be outstripped by increased need. More

Americans are living longer and require more operations and more

blood transfusions. New safety requirements, new donor exclusion

rules, and increased costs are pressuring the blood supply. Although we have heard differing assessments about the degree of seriousness of blood shortages, everyone is in agreement that action

must be taken.

To that end, at the October 6 hearing, Surgeon General David

Satcher outlined a 5-point strategy for increasing the blood supply.

As I indicated at that hearing, I will be supportive of Dr. Satcher’s

efforts to increase blood donations.

This subcommittee and I will also point out ways to improve

blood safety and availability. For example, Chairman Bliley and I

are pushing to get improved blood safety reporting now. I look forward to the witnesses’ testimony and am particularly interested in

hearing about the blood banks’ view on Dr. Satcher’s plans and

how they plan to increase donations.

As we have learned, the U.S. blood supply is indeed fragile. This

subcommittee will continue to monitor the situation, keep the blood

supply on our radar screen, and support volunteer blood donations.

And, in addition, I guess you could somewhat say, putting my

money where my mouth is on this issue, in addition to personally

donating blood this last week, I have joined the Congressional Honorary Host Committee for National Volunteer Blood Donor Month

2000. I want to encourage all members and staff in this Congress

to participate in the Year 2000 Fight for Life on Capitol Hill, a

friendly contest between Republican and Democrats, to see who donates more blood.

[The prepared statement of Hon. Fred Upton follows:]

PREPARED STATEMENT OF HON. FRED UPTON, CHAIRMAN, SUBCOMMITTEE ON

OVERSIGHT AND INVESTIGATIONS

This morning the Subcommittee continues its oversight hearings on the safety

and availability of the U.S. blood supply. At previous hearings, we heard from the

GAO that the blood shortage situation was overstated. Today we will hear a much

different story from the blood collection side.

Today’s testimony and reports from around the country indicate that our blood

supply is below comfort level in many regions. More current information than that

reviewed by the GAO suggests overall trends threaten the blood supply. For example, the American Red Cross will tell us that in the last two years while they have

seen blood collections increase by 8%, blood distribution to hospitals has increased

by 11%. An August 1999 survey of members of America’s Blood Centers showed a

7% increase in demand over August 1998.

The Midwest has historically been the bloodbasket for the rest of the country. I

understand from America’s Blood Centers that some blood centers in the Midwest

that had never or rarely gone on emergency appeal, went on emergency appeal in

1999.

This past summer in my home state of Michigan, the American Red Cross declared a blood alert in Michigan because of decreased donor turnout. The southeastern Michigan region of the Red Cross had less than a one-day supply of blood

in inventory.

One of the themes we will hear at this hearing is the need for national leadership

to support volunteer blood donations. I am delighted to provide some of this national

leadership. For the past month, the Subcommittee has held hearings on the safety

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and availability of the blood supply. I anticipate chairing further hearings on bloodrelated issues throughout this Congress. Last week in Benton Harbor, I donated

blood. I urge others to donate blood. We will hear from one family today on how

that blood donation truly is the gift of life.

Without a significant effort to increase blood donations, our blood supply will

gradually be outstripped by increased need. More Americans are living longer and

require more operations and more blood transfusions. New safety requirements, new

donor exclusion rules, and increased costs are pressuring the blood supply. Although

we have heard differing assessments about the degree of seriousness of blood shortages, everyone is in agreement that action must be taken. To that end, at the October 6 hearing, Surgeon General David Satcher outlined a five-point strategy for increasing the blood supply. As I indicated at that hearing, I will be supportive of Dr.

Satcher’s efforts to increase blood donations. The Subcommittee and I will also point

out ways to improve blood safety and availability. For example, Chairman Bliley

and I are pushing to get improved blood safety reporting now.

I look forward to the witnesses’ testimony. I am particularly interested in hearing

about the blood banks’ views on Dr. Satcher’s plans and how they plan to increase

donations.

As I have learned, the U.S. blood supply is fragile. This Subcommittee will continue to monitor the situation, keep the blood supply on our radar screen, and to

support voluntary blood donation.

And I am putting my money where my mouth is on this issue. In addition to personally donating blood, I have joined the Congressional Honorary Host Committee

for National Volunteer Blood Donor Month 2000. I want to encourage all Members

of Congress and their staff to participate in the year 2000 Fight for Life on Capitol

Hill, a friendly contest between Republican and Democrats to see who donates the

most.

Mr. UPTON. Mr. Chairman.

Chairman BLILEY. Thank you, Mr. Chairman, for these continued

hearings concerning the safety and availability of the Nation’s

blood supply. I also want to thank you, Mr. Chairman, for your

hard work in bringing attention to the U.S. blood supply and to

thank you for stepping up to the plate and donating blood. I hope

maybe it will slow you down a step or two on the tennis court when

we next play.

The blood supply, you know, ladies and gentlemen, is like an insurance policy. You don’t think much about it until you need it.

But most of us or our loved ones at some point in our lives will

need blood.

Today’s testimony paints a troubling picture about whether we

will have the blood we need. It is a more troubling picture about

the blood supply than what we heard from the GAO at the September 23 hearing. On the front lines of blood collection in the

United States, these blood centers represented before this subcommittee are seeing evidence of a blood system struggling to meet

demand. For example, the American Red Cross will tell us that in

the last 2 years, while they have seen blood collections increase by

8 percent, blood distribution has increased by 11 percent. Other

testimony will show that some blood centers which usually do not

resort to emergency appeals for donations during the year are making several such appeals this year.

With the challenge to meet increased demand for blood products,

today’s witnesses are calling for national leadership to support volunteer blood donation. This committee, through these hearings on

the blood supply, has stepped up to the plate to provide some of

this leadership. We are pushing for more blood donations and for

more safety of the blood supply. For example, on the blood safety

front, I have pushed for a new reporting system for blood errors

now, rather than wait for FDA to take at least 6 years to impleVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00112 Fmt 6601 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
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ment recommendations from the HHS Inspector General to repair

its flawed reporting system.

I am pleased that at the last hearing, Surgeon General David

Satcher was not only receptive to my request to implement a new

reporting system for transfusion errors that will improve blood

safety, but he announced that an outside HHS advisory committee

will meet on this matter in January. I am optimistic that we can

improve the safety of the blood supply just as we have done with

the commercial airline safety and nuclear power.

Fred Upton and I will continue to push for improvements and

quick action on the U.S. blood supply.

Mr. Chairman, I join your call to the American people for more

blood donations. Just one pint of blood can save several people’s

lives. Thank you.

Mr. UPTON. Mr. Chairman, if I had known that by donating

blood we could get a 12-0 score a couple days later, I would do it

every week.

Chairman BLILEY. Then you better cut it off.

Mr. UPTON. Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman. I do want to thank you

for holding this hearing and also for the work that you do in this

area, and also as I listened to our full committee chairman, Mr.

Bliley, I want to thank him also for his sponsorship of legislation

in regard especially to the safety of our blood supply.

Certainly the two issues that are important—and I am not going

to go on and on because I am anxious to hear the very competent

and qualified testimony from the panel that we have, panel of witnesses that we have today—but certainly what concerns all of us

across this country is the two issues of supply: the amount of supply, the abundance of supply, and the safety of that supply. And

certainly it is our responsibility as Members of Congress to, and

particularly this committee and this subcommittee, to help oversee

those two very important issues.

So I think we are doing our job today as we have been in past

hearings. I appreciate very much the testimony that we have had

in the past, and certainly I think we are going to hear a little different version or story today. But I do appreciate our Surgeon General, Mr. Satcher, and some of the things he is recommending regarding the blood supply and safety issues.

But again, I look forward to the testimony, not only listening to

it, but also perhaps getting to read some of it. As those of you who

have been in Washington know, sometimes the pulls and tugs of

other committees come into play, and I have another subcommittee

involving the Food and Drug Administration going on that will be

starting at about 10 o’clock, so I am going to try to be shuffling

back and forth between the two committees.

Again, with that, I would yield back my time.

[Additional statement submitted for the record follows:]

PREPARED STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN CONGRESS FROM

THE STATE OF TEXAS

Thank you, Mr. Chairman, for scheduling this important hearing.

There are several important issues to be discussed before this Committee today.

Most importantly, however, is to examine recent trends that indicate that blood doVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00113 Fmt 6601 Sfmt 6621 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
111

nations in this country are on the decline, and what that means for our nation’s

health care establishment.

This trend, combined with the rise in demand for blood, due to an aging population and increased surgical procedures, is a real threat to our nation’s health infrastructure and one that deserves the close scrutiny of this Committee.

We should examine carefully all the options to addressing this situation, including

the controversial proposal to allow the distribution of blood units that are gathered

through the treatment of patients who suffer from hemochromatosis.

We must insure that we first remove any and all financial incentive for donation

before a policy like this is implemented, so as to remove the temptation for these

patients to mislead hospital officials about their medical histories when they go in

to give blood.

Additionally, we must ensure that we act to protect the safety of the blood supply

by supporting new rules designed to exclude donors who may have encountered previously unknown or unsuspected risk factors.

An example of this would be the FDA’s new donor exclusion policy concerning individuals who spent six months or more in the United Kingdom between 1980-1996.

Because of the uncertainty surrounding how the so-called ‘‘mad cow disease’’ may

or may not be spread, this action is an important step that will give us time to determine the seriousness of the threat while avoiding endangering the blood supply

and those who depend on it.

Again, Mr. Chairman, thank you for holding this hearing and I look forward to

the testimony of the witnesses here today.

Mr. UPTON. Thank you. I would let everyone know here that we

have a number of subcommittees that are meeting this morning, so

we are all juggling our time constraints. We welcome everyone

here. I would ask that the witnesses come to the table: Ms. Jacqueline Fredrick, CEO of the American Red Cross Biomedical Services; Dr. Celso Bianco, President of America’s Blood Centers; Mr.

and Mrs. Craig Sperry from the America’s Blood Centers; and Dr.

Susan Wilkinson, Deputy Director of the Clinical and Technical

Services of Hoxworth Blood Center in Cincinnati, Ohio.

Let me just say, I don’t know whether you knew our normal

practice before this subcommittee, but we take testimony under

oath. Do any of you have objection to that?

Hearing none, committee and House rules allow you to be represented by counsel. Do any of you need to be represented—feel the

need to be represented by counsel?

If not, if you would stand and raise your right hands.

[Witnesses sworn.]

Mr. UPTON. You are now under oath. For the purposes of introduction, I would like to introduce and recognize my friend and colleague from Texas, the chairman of the House Agriculture Committee, Mr. Larry Combest.

Mr. COMBEST. Mr. Chairman, thank you very much for letting

me come to introduce three of my constituents and three of your

witnesses today with what is, I think, a very personal and heartfelt

story. Craig, Jennifer, and Kirkland Sperry are from Canyon,

Texas, in my district. I think that this is one of those great stories

that had a wonderfully happy ending. That happy ending happens

to be with us here today. But I think that Kirkland’s father, Craig,

best summed it up, and you will hear their full account, when he

said that a person totally unbeknown to them was willing to give

an hour of their time to allow blood to be—to donate blood in a

very critical moment. That blood supply, literally one pint, saved

Kirkland’s life. I think it points out something we take for granted

many, many times.

112

Thank goodness, Kirkland is here. The Sperrys took their time

to be here, and I appreciate very much, Mr. Chairman, your allowing me to come and introduce them.

Mr. UPTON. We appreciate your time as well. Since you are here,

maybe we will start with the Sperrys, with their testimony. I want

you to know we appreciate all of you sending your testimony in advance. It is made part of the record in its entirety. We would like

you to limit your remarks, if you can, to about 5 minutes. I will

set this very sophisticated timer. It has probably never been tested

on eggs before, but I suspect it works. If you can limit your remarks to about 5 minutes, that will be terrific. We will all listen

for that familiar chime at the end. We recognize the Sperrys first.

Thank you for coming here this morning.

TESTIMONY OF CRAIG AND JENNIFER SPERRY, C/O AMERICA’S

BLOOD CENTERS; SUSAN L. WILKINSON, DEPUTY DIRECTOR,

CLINICAL AND TECHNICAL SERVICES, HOXWORTH BLOOD

CENTER; JACQUELYN FREDRICK, CHIEF OPERATING OFFICER, AMERICAN RED CROSS BIOMEDICAL SERVICES, NATIONAL HEADQUARTERS; AND CELSO BIANCO, PRESIDENT,

AMERICA’S BLOOD CENTERS

Mrs. SPERRY. Thank you for allowing us to be here. This is just

a story that I am sure us, as well as other parents, or hopefully

not many parents, have had to go through, the experience of having to have a pint of blood save your child’s life.

When Kirkland was born, he was diagnosed with a cardiac condition and a seizure disorder. We thought that that was the end of

our problems, as you would think. But when he was 2 months old,

he developed the RSV virus, respiratory syncytial virus, and he

progressed through that very well as far as being in the hospital.

Then one night when we were about to be released, he ended up

coding on us. We were sent out of the room and they were brought

in, and they brought us over to the ICU, and they had done a blood

gas. We thought getting through that was enough, but the doctor

came out and said we have another problem. Of course, the first

thought was maybe something happened with his heart. They came

out and said that not knowing how it was, the virus was attacking

his bone marrow and he needed a blood transfusion and he needed

it now.

Of course, my first reaction was, well, take my blood, because he

and I are both AB positive. Well, he looked at me and said, you

don’t understand. We do not have enough time for you to give your

blood and for it to go through all the testing.

So we are like, okay, we will take that. Then he came back a few

moments later and said, ‘‘Hold on, let your family know, stay here,

we may need you anyway, we can’t find blood.’’ Of course, knowing

that he needs blood and they can’t find it and they are saying we

may still need you anyway, even though we don’t have the time,

it was hard to imagine—I had given blood in the past, taking it for

granted when I needed it, or especially if my son or child needed

it, it would be there.

Just that moment of wonderment, of wondering if it is going to

be there, was going to be there in time enough to make the changes

that it needed to with it, it was definitely a moment unforgetting.

113

Knowing that someone out there gave the little time it took to

give blood, that we still have him here today. My husband put it

pretty good one time. He asked what we would tell people to go

give blood, and my husband said, I just challenge them to look in

any child’s face or look in my child’s eyes and explain to them why

they couldn’t have taken that 30 minutes, 45 minutes’ worth of

their time to save his life or save a person’s life.

It is very simple to do, and we are just grateful that someone

gave that time to do it.

Mr. SPERRY. The only thing I would like to add is many people

don’t realize, and we didn’t realize, when you have the need for

blood, most of us take for granted it is there. When it is sometime

for a blood transfusion or you go on the operating table, your blood

is there. When the doctor comes back to you and says, We can’t

find the blood, it is not in this hospital, it is not in the other hospital, you start to wonder. Luckily for us, believe it or not, it was

the last pint in the city of Amarillo we got, and he was headed out.

So my wife said it, and that is what I have said, it only takes

30 minutes for someone to go give blood. Look in his eyes and that

tells you what you get from giving blood. This little boy is alive.

If you have watched him before this meeting started, he is healthy.

It is a painless procedure, and I advise everybody to give blood. If

they don’t feel like they can, then you can look in his eyes and explain why.

Mr. UPTON. Boy, that was perfect. I even thought about maybe

I should give you an extra 10 minutes since there are three

Sperrys.

But I would like to note that by unanimous consent, all members’

statements will be made part of the record as well.

Dr. Wilkinson, welcome.

TESTIMONY OF SUSAN L. WILKINSON

Ms. WILKINSON. Thank you very much. My name is Susan

Wilkinson and I am pleased to be here today to speak on behalf

of the American Association of Blood Banks. I currently serve as

the President of the AABB, the professional association representing approximately 2,200 institutions, including community

and Red Cross blood centers, as well as hospital transfusion services and 9,000 individuals involved in blood banking and transfusion medicine.

AABB members are responsible for virtually all of the blood collected and over 80 percent of the blood transfused in the United

States. The AABB would like to commend the subcommittee for

holding this series of hearings addressing the critical public health

issues related to blood safety and availability. We would also like

to echo a statement made by Chairman Bliley, as well as several

other members of the subcommittee and previous witnesses that

you have heard, that the Nation’s blood supply is safer than it has

ever been.

However, as you have heard from a variety of witnesses, safety

cannot be considered in a vacuum. Congress and the country must

also pay careful attention to assuring the broad and timely availability of safe blood and blood components.

114

The AABB and professionals in blood banking and transfusion

medicine throughout the country have serious concerns about the

availability of the blood supply. Already there seem to be daily reports of isolated blood shortages across the country. In Cincinnati,

where I serve as Deputy Director of Clinical and Technical Services

at the Hoxworth Blood Center and on the faculty of the University

of Cincinnati, we have issued an unprecedented four emergency appeals to date in 1999.

In the past, we seldom had to resort to such appeals. Although

these shortages are not necessarily nationwide and most often take

place during particular times of the year, they raise health concerns for the blood providers and the patients we serve.

As a national blood data resource center reported to the subcommittee last month, the best available data suggests if current

trends continue, the demand for blood will surpass the supply as

early as the Year 2000. If this forecast proves true, at a minimum,

patients will have to delay elective surgeries, a somewhat misleading term in that certain cancer, orthopedic, and cardiac procedures are considered elective.

The NBDRC data indicates that 8.6 percent of more than 2,000

hospitals surveyed postponed elective surgeries due to a lack of

blood and that nearly 25 percent experienced at least 1 day in

which nonsurgical blood needs could not be met.

If a lack of blood leads to a patient not receiving timely treatment, he or she will certainly consider this a crisis. We strongly believe that the availability of the Nation’s blood supply is a major

public health issue that Congress, the administration, and the

blood banking and transfusion communities cannot afford to ignore.

Several factors contribute to the trend toward a decreased blood

supply and increased usage and they include the following: First,

with the aging population, more people are requiring transfusions

and other blood-related therapies. Advances in many medical areas

have led to the development of additional therapies necessitating

increased blood usage, including cancer treatment, organ transplants, heart surgeries and other therapies.

New safety measures, including policies requiring additional

donor deferrals, have reduced and will almost certainly continue to

reduce, the number of eligible donors.

Finally, the challenges of assuring a continuing stream of committed blood donors and educating the public as to why donating

blood is vital to our Nation’s health have become increasingly difficult.

The AABB strongly urges Congress and the administration to act

now to ensure not only a safe, but an available blood supply as we

enter the new millennium. We recommend the following steps be

taken:

First, in order to be prepared for potential shortages before they

strike, the Federal Government should provide additional support

for blood supply data collection and analysis.

In 1996, recognizing the significant need for blood supply data,

the AABB conceived and founded the National Blood Data Resource Center. In prior years, data had been collected by the Center for Blood Research at Harvard, which received funding from the

National Heart, Lung and Blood Institute.

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When this Federal funding ceased, the AABB saw the need to fill

this void. The AABB is very proud of the fine work the NBDRC has

produced and is excited about its ongoing and future data initiatives. Annual support from Congress and NHLBI is needed to collect and analyze on a routine and timely basis information to better

forecast and take steps to avoid possible blood supply shortages.

The public and private sectors need to work together to increase

retention and recruitment of blood donors. The AABB has been a

supporter of many volunteer recruitment efforts, including the upcoming National Blood Donor Month initiative, a public outreach

campaign to promote increased blood donations. On January 4, as

Chairman Upton stated, Congress will help kick off this month

with a ‘‘Fight for Life Congressional Blood Drive Challenge.’’ We

are pleased to note that Chairman Upton and Representatives

Brown and Waxman have agreed to serve on the honorary committee for this event and we hope other members of the subcommittee will also take this important challenge.

Additional research regarding donor behavior and motivation is

necessary to enhance donor retention and recruitment. The complexities associated with blood donation today, together with everincreasing demand on personal time, have made the recruitment

process more difficult than ever. The AABB has recommended that

the government convene a national meeting to highlight recruiting

efforts and to provide appropriate education on what makes recruitment successful and what makes it fail.

Fourth, policymakers should thoroughly consider the implications

of new blood safety initiatives on availability of this valuable resource. Efforts to enhance safety, even when the risks involved are

theoretical, can have significant effects on the blood supply. For example, it is estimated that FDA’s recent proposal to require deferral of donors who have spent at least 6 months in the United Kingdom between 1980 and 1996 will eliminate 2.2 percent of donations. Moreover, it is particularly troubling that many of those deferred due to this policy will be the community’s most relied upon

repeat donors. Finally, government should help ensure that nonprofit blood centers and transfusion services have adequate resources available to support a safe and available blood supply.

At the same time, costly new blood products and therapies are

being introduced and the FDA is mandating new safety measures.

Federal reimbursement for blood products and services is being severely limited. Nonprofit blood centers and financially strained hospital transfusion services do not have the capacity to absorb these

additional burdens. A timely example is the recent Medicare proposal to establish a prospective payment system for outpatient

services, including transfusion services. Under this proposal, blood

services would be reimbursed at a level far below what they actually cost; in some instances, only one fourth of a procedure’s true

cost.

Faced with such severe underpayments and already tight restricted budgets, many hospitals likely will not be able to offer patients these necessary services.

My final comments to the subcommittee will address error and

accident reporting. The AABB supports the goal of identifying errors and accidents as a means of ensuring that patients receive

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quality care. Since 1958, the AABB has developed standards for

voluntary compliance in blood collection and transfusion. The

AABB also conducts independent assessments and accredits facilities, including blood collection centers and hospital-based transfusion services that are in compliance with AABB standards and

applicable Federal and State regulations.

Since January 1998, the AABB has had in place a quality management system that requires that AABB-accredited facilities have

in place a process to capture, assess, investigate and monitor errors

and accidents. AABB’s accreditation system is well recognized in

the medical community, has been granted deemed status by HCFA

under the Clinical Laboratory Improvement Act, as amended, and

is formally recognized by the Joint Commission on Accreditation of

Health Care Organizations. An error and accident reporting system

should lead to corrective and preventive measures and be designed

to facilitate the ultimate goal of promoting the best possible patient

care.

In conclusion, blood represents the unique public health benefit

for the patients whose lives depend on this resource. We hope that

Congress will work with the blood community in taking the abovementioned steps to ensure a safe and available blood supply. Thank

you very much.

[The prepared statement of Susan L. Wilkinson follows:]

PREPARED STATEMENT OF SUSAN L. WILKINSON ON BEHALF OF THE AMERICAN

ASSOCIATION OF BLOOD BANKS

My name is Susan Wilkinson and I am pleased to be here today to speak on behalf of the American Association of Blood Banks (AABB). I currently serve as President of the AABB, the professional association representing approximately 2,200 institutions, including community and Red Cross blood centers as well as hospital

transfusion services, and over 9,000 individuals involved in all aspects of blood collection, processing, distribution and transfusion. AABB members are responsible for

virtually all of the blood collected and over 80 percent of the blood transfused in

the United States.

The AABB would like to commend the Subcommittee for holding this series of

hearings addressing the critical public health issues relating to blood safety and

availability. We would also like to echo a statement made by Chairman Bliley as

well as several other Members of the Subcommittee—the nation’s blood supply

today is safer than it has ever been. However, as you have heard from a variety

of witnesses, safety cannot be considered in a vacuum; Congress and the country

must also pay careful attention to assuring the broad and timely availability of safe

blood and blood components.

Serious Concerns about Blood Availability

The AABB and professionals in blood banking and transfusion medicine throughout the country have serious concerns about the availability of the blood supply. Already, there seem to be daily reports of isolated blood shortages in geographic communities across the country, from San Diego, to Detroit, to Pittsburgh. In Cincinnati, where I serve as Deputy Director of Clinical and Technical Services of the

Hoxworth Blood Center and on the faculty of the University of Cincinnati, we have

issued an unprecedented four emergency blood appeals this year. In the past, we

seldom had to resort to such appeals and would go for a year without any. Although

these shortages are not nationwide and most often take place during particular

times of the year, they raise real health concerns for blood providers and the patients we serve.

Moreover, as the National Blood Data Resource Center (NBDRC) reported to the

Subcommittee last month, the best available data suggest that if current trends continue, the demand for blood will surpass the supply as early as the year 2000. If

this forecast proves true, at a minimum, patients will have to delay elective surgeries—a somewhat misleading term in that certain cancer or heart surgeries are

considered ‘‘elective.’’ The NBDRC data indicate that 8.6 percent of the more than

2,000 hospitals surveyed postponed surgeries due to a lack of blood and that nearly

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25 percent experienced at least one day in which non-surgical blood needs were not

met. If a lack of blood leads to a patient not receiving timely treatment, he or she

will certainly consider this issue a crisis. We strongly believe that the availability

of the nation’s blood supply is a major public health issue that Congress, the Administration and the blood banking and transfusion medicine communities cannot afford

to ignore.

Likely Causes of Increasing Blood Shortages:

Several factors contribute to the trend toward a decreased blood supply and increased usage. They include the following.

• With the aging of the population, more people are requiring transfusions and

other blood-related therapies. Persons aged 65 or older receive twice as much blood

per capita as younger individuals.

• Advances in a wide array of medicine have lead to the development of additional therapies necessitating increased blood usage, including cancer treatments,

organ transplants, heart surgeries, and other therapies.

• New safety measures, including policies requiring additional donor deferrals,

have reduced and will almost certainly continue to reduce the number of eligible donors. We are particularly concerned about the impact policies, such as the deferral

of donors who have traveled to the United Kingdom for at least six months between

1980 and 1996, will have on preventing reliable, repeat donors from providing this

needed public health resource.

Ways to Ensure a Safe and Adequate Blood Supply:

The AABB strongly urges Congress and the Administration to act now to ensure

not only a safe, but an available blood supply as we enter the new millennium. We

recommend that the following steps be taken in this effort.

• First, in order to be prepared for potential shortages before they strike, the federal government should provide additional support for blood supply data collection

and analysis. In 1996, recognizing the significant need for blood supply data, the

AABB conceived and founded the National Blood Data Resource Center. In prior

years, data had been collected by the Center for Blood Research at Harvard Medical

School, which received funding from the National Heart Lung and Blood Institute.

However, when this federal funding ceased, there was a clear vacuum in public or

private support for national blood data collection, which the AABB saw the need to

fill. The AABB is very proud of the fine work the NBDRC has produced and is excited about its ongoing and future data initiatives. We are also very pleased that

the NHLBI has agreed in the short-term to purchase data from the NBDRC, which

will help enable the Center to gather more timely, monthly data regarding the blood

supply. Additional, annual support from Congress and NHLBI is needed to collect

and analyze on a routine, timely basis information to even better forecast and take

steps to avoid possible blood supply shortages.

• The public and private sectors need to work together to increase retention and

recruitment of blood donors. The AABB has been a supporter of many donor recruitment efforts, including the upcoming National Volunteer Blood Donor Month initiative. The AABB invites Members of the Subcommittee, their staffs and all of Capitol

Hill to participate in this special event in January 2000. This annual event sponsored by a coalition of blood organizations spearheaded by the AABB and including

America’s Blood Centers and the American Red Cross involves a broad public outreach campaign to increase awareness about the need to donate blood and promote

increased blood donations. On January 4, 2000, Congress will help to kick-off the

month with the ‘‘Fight for Life Congressional Blood Drive Challenge,’’ which pits Republicans and Democrats against each other in a friendly battle to see which side

of the aisle can contribute the most blood. We are pleased to note that Chairman

Upton and Representatives Brown and Waxman have agreed to serve on the honorary committee for this event and we hope that all of their colleagues on the Subcommittee will participate in this important effort.

• Additional research regarding donor behavior and motivation is necessary in

order to enhance donor retention and recruitment. The complexities associated with

blood donation today together with the ever-increasing demands on personal time

have made the recruitment process more difficult than ever. Discussions during a

variety of public meetings have revealed a lack of understanding of the full range

of difficulties associated with recruiting and retaining donors. In this light, the

AABB has recommended to the Advisory Committee on Blood Safety and Availability that the government convene a national meeting to highlight recruiting efforts and to provide appropriate education on what makes recruitment succeed and

what makes it fail. The AABB also believes there is a need for research into behavioral sciences to determine what motivates individuals to donate. In 1998, the

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AABB’s National Blood Foundation (NBF) provided funding for an NBDRC survey

regarding donation incentives. In the near future, the NBF will award an additional

$175,000 grant to study the blood donation decision process. In addition, we recommend a critical review of donor suitability requirements to provide recommendations on how to streamline the process and delete unnecessary and outdated requests for information. Both federal and private support for research efforts is essential if we are to obtain critical information to increase donations as soon as possible, and before more drastic blood shortages occur. • Policymakers should thoroughly consider the implications of new blood safety

initiatives on availability of this valuable resource. Efforts to enhance safety, even

when the risks involved are theoretical, can have significant effects on the blood

supply. For example, it is estimated that FDA’s recent proposal to require deferral

of donors who have spent at least six months in the United Kingdom between 1980

and 1996 will eliminate 2.2 percent of donations. This may not seem like a high

number, but when combined, each such chipping away at the blood supply can add

up to a significant public health dilemma. Moreover, it is particularly troubling that

many of those deferred due to this policy will be the community’s most relied on

repeat donors. In addition, the ensuing donation reductions are likely to be even

more severe in certain locales—for instance, East Coast cities. We were pleased to

hear that FDA intends to gather and analyze additional data regarding the impact

on the blood supply as this deferral policy is implemented and scientific information

about the actual threat of new variant Creutzfeldt-Jakob disease (nvCJD) transmission through blood. Blood availability should not be unduly reduced absent a

true blood safety risk.

• Finally, the government should help ensure that nonprofit blood centers and

transfusion services have adequate resources available to support a safe and available blood supply. At the same time costly new blood products and therapies are

being introduced and the FDA is mandating new safety measures, federal reimbursement for blood products and services is being severely limited. Nonprofit blood

centers and financially strained hospital transfusion services do not have the capacity to absorb these additional financial burdens.

A timely example is the recent Medicare proposal to establish a prospective payment system for outpatient services, including transfusion services. Under this proposal, blood services would be reimbursed at a level far below what they actually

cost. For example, Medicare would pay only $325 for therapeutic apheresis, a therapy used to treat individuals with severe medical conditions, including certain lifethreatening blood disorders, which in reality costs closer to $1,400 to provide. Faced

with such severe underpayments and already tightly restricted budgets, many hospitals likely will not be able to offer patients this necessary care.

Shortfalls in blood-related reimbursement have even a larger impact in the inpatient setting, where the vast majority of blood services are provided. Medicare and

private reimbursement payments lag far behind the state of blood-related care and

medical technology. FDA and the blood community continue to move forward in requiring notable new blood safety measures. But the Health Care Financing Administration (HCFA) is not providing fair reimbursement to cover these safety measures. The AABB strongly urges Congress to act to ensure that Medicare provides

fair payments for blood safety measures as soon as they are approved by the FDA.

Just as blood safety is a national priority, assuring fair payments and patient access

to quality blood therapies should be a priority as well. Recognizing this fact as well

as the underlying reimbursement problem, the federal Advisory Committee on Blood

Safety and Availability recently adopted a resolution recommending that the Secretary of the Department of Health and Human Services work with Congress to

seek additional resources to support the introduction and maintenance of mandated

blood safety measures. We hope that Congress will act immediately to ensure necessary coordination of blood-related policies at FDA and HCFA and other divisions

of HHS. By enhancing reimbursement to fair levels, you can help guarantee that

patients have access to the safest and best possible blood products and therapies.

Error and Accident Reporting

Congress and other policymakers should also consider these decreases in reimbursement and the increasing budgetary constraints facing blood centers and hospital transfusion services, along with the all-important impact on blood safety and

patient care, as you address the issue of error and accident reporting. The AABB

supports the goal of identifying errors and accidents as a means of ensuring that

patients receive quality care. Since 1958, the AABB has developed standards for voluntary compliance in blood collection, processing and transfusion. The AABB also

conducts independent assessments and accredits facilities, including blood collection

centers and hospital-based transfusion services, that are in compliance with AABB’s

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Standards and applicable state and federal regulations. Since January 1998, the

AABB has had in place a quality management system that requires AABB-accredited facilities to have in place a process to capture, assess, investigate, and monitor

events that deviate from accepted policy or procedure or that fail to meet AABB

Standards and other applicable regulations and requirements. AABB’s accreditation

system is well-recognized in the medical community, has been granted deemed status by HCFA under the Clinical Laboratory Improvement Act, as amended (CLIA),

and is formally recognized by the Joint Commission on Accreditation of Healthcare

Organizations (JCAHO).

In establishing an error and accident reporting system, we believe that the most

important question is what will be done with the information collected. An error

and accident reporting system should lead to corrective and preventive

measures and be designed to facilitate the ultimate goal of promoting the

best possible patient care. Policymakers must be aware that any new regulation

which requires additional man-hours of data collection and submission, if gathered

to no useful corrective purpose will only serve to further divert strained hospital

staffing resources away from patient care. Such an outcome would threaten to worsen, rather than improve the safety of transfusion services.

Conclusion

Blood represents a unique public health benefit for the patients whose lives depend on this resource. As the federal Advisory Committee on Blood Safety and

Availability recognized during a recent meeting, blood merits special attention due

to several of its unique characteristics—including the fact that it is a donated national resource and is provided, in the vast majority of cases, by nonprofit institutions. We hope that Congress will work with the blood community in taking the

above-mentioned steps to ensure a safe and available blood supply.

Mr. UPTON. We do appreciate your work. Thank you.

Ms. Fredrick, welcome.

TESTIMONY OF JACQUELYN FREDRICK

Ms. FREDRICK. Mr. Chairman and members of the subcommittee,

I am pleased to be here today to discuss the issues of safety and

availability of the Nation’s blood supply. My name is Jackie

Fredrick, and I am the Chief Operating Officer and responsible

head of the American Red Cross Blood Services.

Red Cross Blood Services is the Nation’s largest supplier of blood

products, serving more than 3,000 hospitals across the country.

Today I want to address the vital public health issue of ensuring

an adequate blood supply. I am going to highlight for you what the

Red Cross has been doing to meet this challenge.

As Chairman Bliley, Chairman Upton, and Surgeon General

Satcher have all stated, the Nation’s blood supply is safer than

ever before. Now we must work together to make the same intellectual and financial investments to ensure the availability of the

blood supply.

During the past decade, the Red Cross has made substantial investments in procedures, programs and equipment to continually

improve the safety of the blood supply. We have invested more

than $300 million over the past 5 years alone in the establishment

of eight state-of-the-art laboratories, a single computer system that

maintains the world’s largest blood donor data base, standard operating procedures in all of our blood centers, and an independent

quality assurance program.

Most recently, the Red Cross has been at the forefront in the implementation of nucleic acid testing, or NAT, having invested well

over $17 million. I would refer you to my written statement for a

thorough description of our surveillance programs for emerging infectious diseases and our error and accident reporting systems. We

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are especially pleased to hear the subcommittee highlight the important research of Dr. Harold Kaplan, as the Red Cross has lent

significant support to his project on error and accident reporting.

Although blood safety is our top priority, we are strongly committed to increasing the availability of the blood supply. Compared

to the more than $300 million that the Red Cross has invested to

improve the safety of the blood supply, we have had only a small

fraction of that amount available to us to invest in the availability

of the blood supply.

The Red Cross collected more than 6 million units of blood last

year. Over the past 2 years, as you have heard, we have increased

collections by 500,000 units, or 8 percent. During that same time

period, however, our distribution of blood to hospitals has increased

11 percent.

It is clearly evident that even in good times, the Nation’s blood

supply is fragile. While blood donations in some parts of the county

are increasing, donations in other areas have been on the decline.

From 1994 to 1999, the largest urban areas served by the Red

Cross, such as Detroit, Philadelphia, and Baltimore, have experienced a decline in donations of more than 9 percent. For that same

time period, there has been an 8 percent rise in donations in the

rural midwestern areas of the country and an 11 percent increase

in the Sunbelt and western portions of the country served by the

Red Cross.

With our nationwide blood system, we are able to move this precious resource wherever and whenever it is needed. Part of availability is making sure the right blood is in the right place at the

right time, and the Red Cross last year moved over 650,000 units

of blood to areas of need.

To counteract these supply and-demand trends, the Red Cross is

engaged in a number of efforts to continuously recruit new donors

and retain previous donors. These initiatives include implementing

innovative donor recruitment and retention techniques using stateof-the-art technology; identifying best practices to be used throughout the Red Cross system; improving the convenience and comfort

of the donation experience; reaching out to minority and youth populations; and investigating the use of technologies such as the

Internet to reach current donors.

If we are to cultivate the next generation of blood donors, we

need to look to youth and segments of our society who have been

underrepresented in the donor pool. Later this year the Red Cross

will launch the first program in a 3-year minority recruitment initiative patterned after a highly successful program at North Carolina Central University, resulting in tenfold increase in donations.

We currently are working with over 70 historically black universities and colleges on this effort.

If we are to meet the public health challenge of an adequate

blood supply, the Federal Government must partner with the Red

Cross and our independent blood center colleagues. We must work

together to ensure that appropriate resources, both human and

monetary, are invested to meet the Nation’s future blood need. This

includes funding additional research on donor motivation, studies

to help us monitor the supply, and especially blood utilization, public education campaigns targeted at making the public generally

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aware of the critical importance of donating blood, and making the

process more user friendly.

Finally, because blood centers are operating in the same managed care environment as hospitals, we face similar pressure to reduce costs while increasing the quality of our services. We are very

concerned about HCFA’s proposed rule covering outpatient services, as it would not adequately cover the cost to hospitals for the

majority of products and services provided by blood centers. The

proposed rule jeopardizes Medicare patient access to the most lifesaving therapies.

Mr. Chairman, I would like to join your fellow committee members who have thanked you for holding these hearings. They have

assisted greatly in raising the awareness and importance of blood

safety in our Nation. I also want to thank you personally for your

commitment and your blood donation in Great Lakes. Our staff enjoyed your visit and expects you back in exactly 48 days.

This concludes my prepared statement. I would be happy to answer any questions you or members might have.

Mr. UPTON. I thought it was 56 days.

Ms. FREDRICK. You donated last week.

Mr. UPTON. You are already counting. I understand.

[The prepared statement of Jacquelyn Fredrick follows:]

PREPARED STATEMENT OF JACQUELYN FREDRICK, CHIEF OPERATING OFFICER, AMERICAN RED CROSS BIOMEDICAL SERVICES

Mr. Chairman and Members of the Subcommittee: I am pleased to be here today

to discuss the issues of safety and availability of the nation’s blood supply. My name

is Jackie Fredrick, and I am the chief operating officer and responsible head of

American Red Cross Blood Services. Red Cross Blood Services is the nation’s largest

supplier of blood components, serving more than 3,000 hospitals across the country.

Last year, we collected more than 6 million units of whole blood through the generous donations of approximately 4.5 million volunteer donors. Each day, 22,000 donors visit one of 400 Red Cross blood donation sites. For more than 50 years, the

Red Cross has remained an innovator and a leader in transfusion medicine and research. The Red Cross has provided the nation with safe and reliable blood components and products for generations. Through blood services, the Red Cross is touching more lives than ever before.

Today, I am here to address the vital public health issue of ensuring an adequate

blood supply. I am going to highlight for you what the Red Cross has been doing

to meet this challenge. We have made substantial investments to improve safety.

Indeed, as Chairman Bliley, Chairman Upton and Surgeon General Satcher have all

stated, our nation’s blood supply is safer than ever before. Now, we must work together to make the same intellectual and financial investments to ensure the availability of the blood supply.

Safety Initiatives Undertaken by the Red Cross

During the past decade, the Red Cross has made substantial investments in procedures, programs and equipment to continually improve the safety of the nation’s

blood supply. We have invested more than $300 million over the past five years

alone in the establishment of eight state-of-the-art testing laboratories; a single,

standardized computer system that maintains the largest blood donor database in

the world; standardized operating procedures in our 37 Blood Services regions; and

an independent quality assurance program with more than 200 experts who monitor

every aspect of our operations to ensure compliance with our standard operating

procedures and all federal regulations.

The Red Cross has been proactive in its efforts to ensure that new, viral screening

tests are implemented as soon as they become available. Most recently, the Red

Cross has been at the forefront in the implementation of nucleic acid testing, or

NAT, having invested $17 million on this effort. NAT, which the Red Cross is conducting under an Investigational New Drug protocol, has the potential to detect the

actual DNA of the virus in a blood donation rather than waiting for the body’s response to the virus through the creation of antibodies, as most currently licensed

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tests do. As such, NAT may greatly reduce the ‘‘window period’’—the time between

when an individual is infected and the point at which evidence of the virus can be

detected in that person’s blood. As Surgeon General Satcher stated, NAT will be especially helpful in screening donations from individuals newly infected with the hepatitis C virus (HCV) and the human immunodeficiency virus (HIV).

Red Cross Surveillance Activities

Each year the Red Cross invests more than $20 million in basic and applied research at our Jerome H. Holland Laboratory for the Biomedical Sciences, one of the

world’s premier blood research facilities. At the Holland Laboratory, more than 270

world-class Red Cross scientists and technicians evaluate and monitor possible

threats to the blood supply and develop cutting-edge technologies that bring innovative products and services to patients. We actively monitor and detect the emergence

of infectious diseases through ARCNET, the most comprehensive blood collection-related epidemiological database in the world. This includes 16 million records, with

each record consisting of donor demographics, screening test results and deferral

history.

The Red Cross monitors the blood supply for emerging infectious diseases. For example, Holland Laboratory researchers have conducted a number of studies on

Chagas disease and tick-borne diseases such as babesiosis. Red Cross regional staff

are also involved in a study to assess the risk of bacterial contamination of blood

products—referred to as the BaCon study.

Surveillance within the Red Cross extends beyond research. Through its quality

assurance program, the Red Cross has sophisticated surveillance programs in place

to monitor and review all elements involved in collecting, manufacturing, testing

and distributing blood components. For example, a system of ‘‘In-Process Reviews,’’

or IPRs, has been established at each of the Red Cross’s eight national testing laboratories. IPRs consist of reviews and documentation of all critical control points in

the testing process to ensure that testing technicians have performed each task in

the testing process correctly. Another level of review follows the IPR and ensures

that documentation for all testing is recorded correctly. Finally, there are quality

control and quality assurance steps, which include another round of review of infectious disease test results and general system audits. Together these levels of review

enable us to track and trend all unexpected outcomes and helps to ensure our compliance. Next year the Red Cross will implement a new laboratory information system that will automate many functions now performed by employees.

For some time, the FDA has required licensed, registered blood establishments,

including the Red Cross, to report errors and accidents as a tool to ensure the safety, potency and purity of blood and blood products. The Red Cross has achieved a

high degree of compliance in reporting errors and accidents in a timely manner, as

required by the FDA. The Red Cross encourages the application of any measures

that may increase the safety of the blood supply including the research that is being

conducted by Dr. Harold Kaplan that includes a new method for reporting errors

and accidents. We were pleased to hear that Dr. Kaplan’s important research was

brought to the Subcommittee’s attention at its last hearing. The Red Cross has lent

significant support to this research because of its potential to enhance the current

error and accident reporting system by assessing and correcting errors before they

happen.

Ability of the Blood Supply to Meet Anticipated Patient Needs

The Red Cross has not only committed financial resources, but also invested in

human talent by bringing together the best in the field to make improvements to

the safety of the blood supply. We are equally committed to blood availability. To

address future needs in blood availability, however, we will need to make the same

financial and intellectual investment as we have with blood safety.

The Red Cross collected more than 6 million units of blood last year. We have

seen an increase of 500,000 units in our collections over the past two years, an 8

percent increase. During that same time period, however, our distribution of blood

to hospitals increased by 11 percent. The increase in demand is also reflected in the

fact that very few components expire before they can be used, and that number continues to decrease.

Recent studies by the National Blood Data Resource Center (NBDRC) and the

General Accounting Office (GAO) have highlighted concerns about the availability

of blood components. Both NBDRC and the GAO cite trends in collections and demand for blood that point to possible widespread shortages in the near future. The

Red Cross shares its data with the NBDRC, and during the time period of the

NBDRC study (1994-1997), we had a decline in donations of 2 percent, while the

NBDRC report shows a similar nationwide decline of 5 percent. We look forward

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to continuing our work with the NBDRC to build upon the progress that has been

made in collecting comprehensive data on the supply and utilization of blood.

Although we have seen an increase in donations overall, there are times when individual Red Cross Blood Services regions experience serious shortages of certain

blood types. As the GAO pointed out in its study, shortages tend to be in specific

blood types such as O and B, with type O in shortest supply because it is the universal blood type. Shortages tend to occur during the summer months and holiday

seasons, and in times of bad weather. For example, in September, before Hurricane

Floyd, Red Cross Blood Services regions in the Southeastern United States made

sure that their hospitals had stocked shelves to meet patient needs. During and

after Hurricane Floyd, many previously scheduled blood drives had to be cancelled

throughout much of Virginia, North Carolina and South Carolina resulting in the

loss of approximately 10,000 units to the Red Cross system. Through our nationwide

system, the Red Cross was able to ensure that hospitals in this area of the country

had an uninterrupted supply of blood throughout the storm and its aftermath with

18 regions shipping in approximately 8,000 units.

It is clear that, even in good times, the nation’s blood supply is fragile. While

blood donations in some parts of the country are increasing, donations in other parts

have been in decline. For example, from 1994-1999, the largest urban areas served

by the Red Cross, such as Detroit, Philadelphia and Baltimore have seen a decline

in collections of more than 9 percent. For the same time period, we have seen an

8 percent rise in donations in the rural Midwestern areas of the country. The Sunbelt and Western portions of the country served by the Red Cross have experienced

an even more dramatic increase in donations—more than 11 percent during the past

five years. The Red Cross nationwide blood services system allows us to move blood

to hospitals wherever and whenever it is needed. During the past year, we made

available 650,000 units from sections of the country where there was a sufficient

supply to those areas where this resource was needed. Market research has indicated that donors are driven by altruistic reasons. Once their local community needs

are met, they welcome the opportunity for their life-giving donation to help people

in other parts of the country.

The aging of the U.S. population impacts both the supply and demand for blood.

As a group, older Americans (Americans over the age of 65) tend to require more

blood than other age groups. In addition, as these individuals age, we lose our most

dedicated, repeat blood donors. To meet anticipated future demands upon the blood

supply, the Red Cross is working smarter and more efficiently to increase our collection base. We are applying the same proven techniques used by corporate America

to understand and attract customers—and in our case to make blood donation more

appealing.

We are engaged in a number of efforts to continuously recruit new donors and

retain previous donors. These initiatives include:

• implementing innovative donor recruitment and retention techniques using stateof-the-art technology;

• identifying best practices to be used throughout the Red Cross system;

• improving the convenience and comfort of the donation experience;

• reaching out to minority and youth populations; and

• investigating other ways to apply technology, such as the Internet, to reach potential and current blood donors.

The Red Cross is currently piloting new blood drive scheduling software to improve the efficiency of blood drives, enhancing the experience for both the donor and

blood drive managers. We are implementing a new nationwide telerecruiting system

that allows the Red Cross to contact more donors, more often, and in a more efficient manner. Use of the Internet as a means of scheduling donor appointments also

holds tremendous promise.

As the Subcommittee has heard from other witnesses, the Blood Donor Record,

or BDR, is a lengthy document that requires donors to answer very personal questions that are required by FDA standards. As part of our effort to use technology

to make our system painless and paperless, we are working with leading technology

companies to develop hand-held, computerized BDRs that will give blood donors

more privacy and speed up the health history process.

The Red Cross is striving to identify the most effective ways of doing business in

donor recruitment and collections. Our PRIDE project team (Process Reengineering

and Improvements Done by Everyone) is examining the best business practices in

our system and ensuring their implementation throughout our 37 regions. The

team’s work encompasses donor recruitment and collections, production and distribution, sales and marketing, quality assurance, performance management and organizational design.

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As the Subcommittee has stressed, it is important not only to attract new donors,

but to retain them after their initial experience. Research has indicated that donations from individuals who are repeat donors tend to be safer than those from firsttime donors. The Red Cross has performed research on donor motivation and what

it takes to bring people back. Through focus group research, we know that it is important for volunteer donors to feel a connection with the patients who benefit from

the gift of their donation. We also know that donors find it important to be part

of the Red Cross ‘‘family.’’ To drive this point home, we are conducting a pilot program in the Southeastern United States called ‘‘Hero’s Welcome,’’ which shares the

story of blood donation and the people it helps. As we approach the holidays and

the year 2000 date change, the Red Cross is launching a special blood donation initiative called ‘‘Millenium Hero.’’ The program is intended to ensure adequate donations prior to and following January 1, 2000.

Donor comfort is important to ensuring that people have as pleasant an experience as possible when they take time out of their busy schedules to donate. We are

investigating the development of ergonomic chairs and looking for ways to measure

donors’ hemoglobin levels or ‘‘hematocrit’’ without having to perform an ear or finger

stick. Our goal is to foster an environment that is friendly and painless, as well as

one that encourages repeat donations.

If we are to cultivate the next generation of blood donors, we need to look to youth

and segments of our society who have been underrepresented in the blood donor

pool. Later this year, we will launch the first program in a three-year minority recruitment initiative. This exciting program, entitled ‘‘The Power is in You,’’ encourages blood donation by African Americans and is based on a highly successful effort

at North Carolina Central University, spearheaded by Ted Parrish, which has increased blood donation on campus tenfold. The Red Cross currently has relationships with 76 of the 118 historically black colleges and universities. By working

with historically black colleges and universities, we hope to increase blood donation

on campus and throughout the African-American community.

The Red Cross is launching regional and national youth recruitment initiatives,

such as ‘‘It’s What’s Inside That Counts’’ and ‘‘Generation V,’’ which enable high

school and college blood drive coordinators and their teams to run frequent and successful blood donation programs. At the elementary school level, we have held blood

drives in which children are first educated about the need for blood donation and

then recruit their parents and teachers to donate blood. By teaching the importance

of blood donation at an early age, we hope it will encourage these youth to become

donors when they are old enough to do so.

Dedication of Red Cross Resources

The possibilities to increase blood donation are numerous, and to us, exciting. As

a not-for-profit organization, however, the Red Cross must be a careful and responsible steward of its funds, and scarce resources must be prioritized. Accordingly, our

highest priority has been to increase the safety of the blood supply. As I said earlier,

since 1994, the Red Cross has invested more than $300 million in technologies and

systems to improve the safety of the blood supply. In comparison, during the same

five-year period, we have had only a small fraction of that amount available to invest in the availability of the blood supply.

Need for Federal Support

The federal government must partner with the Red Cross and our independent

blood center colleagues to meet the public health challenge of an adequate blood

supply. We must work together to ensure that the appropriate resources, both

human and monetary, are invested to meet the nation’s future blood needs. This includes funding additional research on donor motivation, studies to help us monitor

the supply and utilization of blood, and public education campaigns targeted at

making the general public aware of the critical importance of donating blood. In addition, the screening process for blood donors must be made more user-friendly. For

example, the FDA should consider allowing blood centers to simplify the BDR, especially for repeat donors.

We are committed to bringing the best science to the donor screening process. We

view with concern, therefore, the recent recommendation from FDA requiring that

anyone who has spent more than 6 months in the United Kingdom between 1980

and 1996 be indefinitely deferred from donating blood. There is very little science

supporting this deferral policy, yet it has been estimated that the nation could lose

at least 2.2% of donations, almost 300,000 units per year, at a time when the blood

supply is marginal. We encourage FDA to review this policy frequently, and we will

assist them by providing whatever data is available and appropriate.

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Finally, because blood centers are operating in the same managed care environment as hospitals, we face similar pressures to reduce our costs, while improving

the quality of our services. Reimbursement programs, such as those administered

by HCFA and other third-party providers, must fully reimburse hospitals and blood

centers to ensure that patients receive the newest and most innovative blood services. We are very concerned about HCFA’s proposed rule covering out-patient services. As proposed, the rule would not adequately cover the costs to hospitals for the

majority of products and services provided by the Red Cross. The proposed rule jeopardizes Medicare patient access to the most up-to-date lifesaving therapies. As the

nation’s largest provider of blood components, we will continue to work with Congress and HHS to ensure the formulation of a fair and reasonable reimbursement

system.

Mr. Chairman, I would like to join your fellow Committee members who have

thanked you for holding these series of hearings. They have assisted greatly in raising the awareness of the importance of blood safety and availability. I also want to

thank you for your personal commitment to ensuring that vital blood components

are available for those in need, as evidenced by your recent donation at our Great

Lakes Region. Our staff enjoyed the time that they spent with you last week and

welcome your return 48 days from now.

This concludes my prepared statement. I would be happy to answer any questions

you or Members of the Subcommittee may have.

Mr. UPTON. Dr. Bianco.

TESTIMONY OF CELSO BIANCO

Mr. BIANCO. Mr. Chairman, thank you for your blood donation.

Mr. Chairman and honorable members of the Commerce Committee, I am Dr. Celso Bianco, Vice President for Medical Affairs

for the New York Blood Center. Today I am honored to represent

America’s Blood Centers as their President. ABC is the federation

of independent community blood centers that provide about half of

this Nation’s volunteer blood donor supply.

On behalf of ABC, I would like to applaud the committee, Chairman Upton and Chairman Bliley and Surgeon General David

Satcher, for their efforts to enhance the safety of the blood supply

through improved error and accident reporting. We address this

topic in separate written comments to the committee. Today my

comments will focus on five very important issues.

First, we ask Congress to encourage the Department of Health

and Human Services, HHS, to do what it can to ensure that a dependable supply of volunteer donor blood is available. Our written

testimony contains copies of letters that outline specific actions

that we believe HHS can contribute.

Over the past 10 years, the need for blood has increased, as data

from the national Blood Data Resource Center clearly demonstrates. At the same time, the number of Americans willing and

able to voluntarily give blood has decreased.

The number of those willing to donate has decreased because

they are too busy and because there has been a decline in support

from corporate America for voluntary blood donations by their employees. The number of those able to donate has decreased because

the Food and Drug Administration continues to add new donor criteria.

We agree with criteria that ensures a safer blood supply. However, we are deferring more and more perfectly healthy Americans

because of speculation.

Community blood centers are working hard to make sure that

this potential crisis does not threaten the health of patients needing blood. It is very important to understand that often the need

126

for blood is urgent, meaning the blood needs to be already on the

shelf when the emergency occurs. We just heard from Mr. and Mrs.

Sperry about that. But ultimately, the blood needs to be there or

lives will be lost. That is why we are so concerned when stocks of

blood are low.

Think of the Oklahoma City bombing, the shootings at Columbine, the school bus hit by the train. Most of the blood used to

save those lives was given within the first few hours of the tragedy.

We live on the edge. For instance, in New York today, we have

a 3-day blood supply of the O-positive blood and 11⁄2 days supply

of the O-negative type blood. We have also asked HHS to eliminate

unscientific barriers to donation, and to encourage eligible Americans to give blood. We believe that the national leadership must

foster a culture of blood donation.

The congressional challenge that you just talked about is an example of this type of leadership.

Second, we recognize that FDA has made great contributions to

blood safety in the past. However, we are now spending more and

more resources chasing theoretical or minuscule risks, such as

those from mad cow disease and malaria, instead of focusing on

well-recognized problems. For example, we defer 50,000 healthy

people a year from donating blood because they visited Mexican resorts in areas defined as malarial zones. Not one of the 10 U.S.

cases of transfusion-related malaria in the last decade was transmitted by someone that visited Mexico. They were all transmitted

by people who emigrated to the U.S. from West Africa.

Similarly, we will defer over 250,000 healthy donors who have

traveled to the United Kingdom because of the theoretical risk of

transmitting variant CJD. Instead, Congress should encourage

FDA to focus on the over 200 Americans reported to FDA who have

died because they got the wrong unit of blood, or because of bacterial contamination. In a 1997 report, the General Accounting Office recommended that FDA focus on these clerical errors and on

preventable transfusion reactions.

Third, we ask that Congress encourage FDA to use science as the

basis for its decisionmaking and that FDA apply consensus development processes, like negotiated rulemaking, when considering

controversial policies. At ABC’s annual meeting this past February,

FDA Commissioner Jane Henney called blood safety one of her

highest priorities. She also pledged that FDA would again become

a science-based organization. We are ready to contribute to joint efforts in this area. We are ready to accept decisions based on

science.

Fourth, we ask that Congress ensure proper representation of

the blood service community on bodies that advise FDA. In a 1996

study of the tragedy of AIDS in the blood supply in the early

1980’s, the Institute of Medicine of the National Academy of

Sciences recommended that FDA strike a proper balance in committee membership, but today there are no representatives of the

blood community on FDA’s most important Blood Products Advisory Committee.

Fifth, we ask that Congress ensure the Health Care Financing

Administration pays for blood safety mandates from FDA. Last

April, Surgeon General Satcher said that, ‘‘We as a society need to

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assure unequivocally that the blood supply is safe.’’ Dr. Satcher

went on to state that we must be ready to pay for safe blood as

a disease prevention, rather than spending money on treatments.

We support Surgeon General Satcher. We understand that HCFA

is looking at the best options to assure that the FDA blood safety

mandates result in a timely change in HCFA’s reimbursement to

hospitals.

In essence, we ask Congress to support volunteer blood donations, to focus FDA on demonstrated safety risks, to encourage

science-based decisions, to ensure adequate representation of the

volunteer blood center community in the Blood Products Advisory

Committee, and to assure adequate HCFA reimbursement.

I thank Congress for this opportunity. Please know that America’s Blood Centers, the community blood centers, will do everything possible to assure the safest and most dependable blood supply possible. Congress must also do what it can to help us meet our

goals.

Thank you. I am open to questions.

[The prepared statement of Celso Bianco follows:]

PREPARED STATEMENT OF CELSO BIANCO, PRESIDENT, AMERICA’S BLOOD CENTERS

Mr. Chairman and Honorable Members of the Commerce Committee. I am Dr.

Celso Bianco, vice president for medical affairs for the New York Blood Center.

Today, I am honored to represent America’s Blood Centers, or ABC, as their president. ABC is the federation of the independent community blood centers that provide about half of this nation’s volunteer donor blood supply.

On behalf of ABC, I would like to applaud the Committee and Surgeon General

David Satcher for their efforts to enhance the safety of the blood supply through

improved error and accident reporting. We address this topic in separate written

comments to the Committee. Today, my comments will focus on five very important

issues.

First, we ask Congress to encourage the Department of Health and Human Services (HHS) to do what it can to ensure that a dependable supply of volunteer donor

blood is available. Our written testimony contains copies of letters that outline specific actions that we believe HHS can contribute. Over the past ten years, the need

for blood has increased—as data from the National Blood Data Resource Center

clearly demonstrate. At the same time, the number of Americans willing and able

to voluntarily give blood has decreased. The number of those willing to donate has

decreased because they are too busy and because there has been a decline in corporate America’s support for voluntary blood donations by their employees. The

number of those able to donate has decreased because the Food and Drug Administration (FDA) continues to add new donor deferral criteria.

We agree with criteria that ensure a safer blood supply. However, we are deferring more and more perfectly healthy Americans because of speculation.

Community blood centers are working hard to make sure that this potential crisis

does not threaten the health of patients needing blood. It’s very important to understand that often the need for blood is urgent, meaning the blood needs to be already

on the shelf when the emergency occurs. We can tinker with the system through

sharing of blood between blood centers and go out on emergency appeal. But ultimately, the blood needs to be there or lives will be lost. That’s why we are so concerned when stocks of blood are low. Think of the Oklahoma City bombing, the

shootings at Columbine, the school bus hit by the train. Most of the blood used to

save those lives was given within the first few hours of the tragedy.

We have also asked HHS to eliminate unscientific barriers to donation, and to encourage eligible Americans to give blood. We believe that the National leadership

must foster a culture of volunteer blood donation.

Second, we recognize that FDA has made great contributions to blood safety in

the past. However, we are now spending more and more resources chasing theoretical or minuscule risks, such as those from mad cow disease and malaria, instead

of focusing on well-recognized problems. For example, we defer 50,000 healthy people a year from donating blood because they visited Mexican resorts in areas defined

as malarial zones. Not one of the 10 U.S. cases of transfusion-related malaria in the

128

last decade was transmitted by someone who visited Mexico! They were all transmitted by people who emigrated to the US from West Africa. Similarly, we will defer

over 250,000 healthy donors who have traveled to the U.K. because of the theoretical risk of transmitting variant CJD. Instead, Congress should encourage FDA

to focus on the over 200 Americans reported to FDA who have died because they

got the wrong unit of blood, or because of bacterial contamination. In a 1997 report,

the General Accounting Office recommended that FDA focus on these clerical errors

and on preventable transfusion reactions.

Third, we ask that Congress encourage FDA to use science as the basis for its

decisionmaking, and that FDA apply consensus development processes, like negotiated rulemaking, when considering controversial policies. At ABC’s annual meeting this past February, FDA Commissioner Jane Henney called blood safety one of

her highest priorities. She also pledged that FDA would again become a sciencebased organization. We are ready to contribute to joint efforts. We are ready to accept decisions based on science.

Fourth, we ask that Congress ensure proper representation of the blood service

community on bodies that advise FDA. In a 1996 study of the tragedy of AIDS in

the blood supply in the early 1980s, the Institute of Medicine of the National Academy of Sciences recommended that FDA strike a proper balance in committee membership. But today, there are no representatives of the blood community on FDA’s

most important Blood Products Advisory Committee.

Fifth, we ask Congress to ensure that the Health Care Financing Administration

(HCFA) pays for blood safety mandates from FDA. Last April, Surgeon General

Satcher said that, ‘‘We as a society need to assure unequivocally that the blood supply is safe.’’ Dr. Satcher went on to state that we must be ready to pay for safe blood

as a disease prevention, rather than spending money on treatments. We support

Surgeon General Satcher. We understand that HCFA is looking at the best options

to assure that FDA blood safety mandates result in a timely change in HCFA’s reimbursement to hospitals.

In essence, this Committee and Congress can support the safety and availability

of the volunteer blood supply by:

1. Supporting volunteer blood donations and encouraging HHS to make this issue

a National priority;

2. Focusing FDA on demonstrated safety risks;

3. Encouraging science-based decisions;

4. Ensuring adequate representation of the volunteer blood center community in the

Blood Products Advisory Committee; and

5. Assuring adequate HCFA reimbursement for measures that increase the safety

and availability of the volunteer blood supply.

I thank Congress for this opportunity. Please know that America’s Blood Centers,

the community blood centers, will do everything possible to assure the safest and

most dependable blood supply possible. Congress must also do what it can to help

meet our common goals.

Thank you.

Mr. UPTON. Thank you all very much.

Again, we got a unanimous consent request earlier that all members’ statements be made part of the record. At this point the members will be asking some questions. We will try to stick to this 5-

minute time clock as well, as we rotate with questions here certainly before the votes.

I have a question that I asked, I guess 2 weeks ago, at our hearing. I asked the audience, though not under oath: How many folks

here have donated blood at least once in their lifetime, raise your

hand?

I am so glad. We want to make sure our blood competition drive

is open to the press as well. Some of us feel like we give blood

every day and they take it.

How many people here have given blood in the last year raise

your hand?

Again, okay. Again I want to make the point you can do that

every 56 days.

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The Sperrys, we appreciated your story, and even more for those

in the audience. I don’t know if they put these books out on the

table, but there is a book that is a weekly calendar put out. We

can make sure that anyone in the audience that would like one, we

will make these available ‘‘Pints for Half Pints.’’ There is a story

on a number of really remarkable kids, most of whom survived.

But your son is there for the first full week in March. It is really

a remarkable story, very touching for him and all of these wonderful children that were highlighted in this, and again it reminds us

about the need for blood.

It sort of reminded me as you told your story and as I read it

in advance as well, in not only giving blood, that everyone that can

ought to do so, but also the story of one of our colleagues, Bill

Young, who has been a leader in the bone marrow tests. I was

among many that participated in a drive here on Capitol Hill to

have my blood marrow tested, stored in a bank, and I can hardly

wait for the day when someone comes and calls and says, We need

you, and I will be there. It is that type of volunteer effort that really does save lives. We witness your son, who has certainly been a

little active this morning. We appreciate that.

You know, I was on C-SPAN this morning, I did calls with my

colleague, Mr. Strickland, who is a member of this subcommittee

as well, and one of the calls that I received was, I believe, a gentleman from Kentucky, who on trips to Ohio had noticed a lot of

people on crack. And his question to me, which I wasn’t able to give

him an answer, but I said I would ask this this morning, was

whether or not these tests in the blood he donated last week—I

know it is NAT-tested later on—my suspicion is that that NAT

test, nucleic acid test, given the acronym NAT, does in fact weed

out anyone that might have some illegal substance in their blood.

Is that true, Ms. Fredrick? Do you want to answer that?

Ms. FREDRICK. That unfortunately is not true. The testing we do

for viruses such as hepatitis and the HIV virus, those viruses happen to be present to a greater extent in people who use illegal

drugs, but we have multiple layers of safety in the blood supply.

The first layer is the health history and the questions we ask.

Though we believe they are rather cumbersome, the purpose of

those is to solicit truthful answers about risk activities that might

put the donor——

Mr. UPTON. That is right. I did note to the gentleman that called

that there was a lengthy questionnaire that took about 10 or 15

minutes to fill out, because they wanted—I mean, the person that

walked through with me, he made sure that everything was answered. I had one question on an anticholesterol drug that I take,

and I told him about that, and he said that shouldn’t warrant any

trouble. But in fact that was a question.

I noted, in fact, that there were some folks, I think there is a

question on tatoos on that, whether you have had a tatoo. I remember that question, because I don’t have any tatoos. I just checked

no.

But go a little bit more on the drugs. I am sorry to interrupt.

Ms. FREDRICK. As you know, we ask extensive questions about

lifestyle. Those questions we do ask about illegal use of drugs for

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injection, because mostly we are concerned about the transmission,

obviously, of viruses such as hepatitis and HIV.

The blood then goes on and is tested for those viruses, but in fact

we cannot do testing for actual presence of any illegal drugs like

crack cocaine.

Mr. UPTON. Okay. Mr. Green.

Mr. GREEN. Thank you, Mr. Chairman. Again, thank you for calling this hearing. This is our third hearing. I was proud for a number of years to give blood, but I guess coming from Houston and

my sinus problems, I have been rejected now for the last 4 or 5

years because of the medication.

That is one of the questions I would ask. I understand, you

know, and I have gone through the questionnaire, because frankly

the church my wife and I attend, we have a blood drive as often

as we can, the Shriners. There is an effort at the Texas Medical

Center in Houston. But I think the outreach more is to nontraditional groups. I do know, for example, churches in my community

that do it, so—because of the fear of the amount of blood supply

and the shortness we have had, particularly over holiday periods

of time.

I know the tatoo issue and things like that. But that is one of

the frustrations that I have tried to do, and I guess there is a fear

because of whatever sinus medication or something you are taking.

Doctor, could you answer that?

Mr. BIANCO. In general, we will not defer a donor because of a

sinus medication. We will defer if they were recently taking an antibiotic because of the fear that there could be some bacteria in the

blood that we take. As it is stored for several days, there is opportunity for those bacteria to grow. But just a sinus medication, just

decongestants, should not be a call for deferral.

But I think you hit a very important problem, Mr. Green. It is

that because of concerns of safety, we have been overzealous, overcautious. Today, as I tried to say in this statement, we are deferring incredible amounts of healthy Americans because of the fear

of that minuscule risk that is there, as if we could eliminate all the

risk.

What we are creating is the shortage on the other side. We discourage a lot of people. You had a reaction that is not the common

reaction. Your reaction was to say, I can’t give, I will get my church

and groups to give. Most of the people that get deferred get very

depressed, very upset, feel rejected, feel they are not healthy, and

they have trouble dealing with that rejection. That is a network.

They don’t encourage other people to donate.

We have to find ways to change that behavior. We have to find

ways we are donating for the whole community. If we don’t give,

we help give.

Mr. GREEN. I understand the reason. Maybe the pendulum

swung so much because of the problems we had a decade ago with

the quality of the blood supply because of the AIDS virus and some

of the tragedies that we have seen. I don’t know if I want to actually weaken it, but I also know maybe we need to—the questionnaire is involved, and I would hope that there would be other ways

you could check the blood.

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Mr. BIANCO. The quality of tests also has changed substantially,

Mr. Green, particularly with the addition of the NAT testing that

we just mentioned. It is our ability to detect those infections and

to shorten what we call the ‘‘window period’’ to days. It is incredible in terms of reducing the risk of transmission of those viruses.

So the history, medical history, becomes in a certain way as one

of the layers a little bit less important than it was in the past.

Mr. GREEN. Ms. Wilkinson, you make a point in your testimony

that there are daily reports of isolated blood shortages. Again, my

district in Houston, I know we have experienced that in geographic

communities all across the country, from San Diego to Detroit to

Pittsburgh. Can you put it in better context for us and explain why

these sporadic shortages are occurring and why this is something

we should be concerned about?

Ms. WILKINSON. I think again it is really twofold. We see less

people who are willing to donate. People have articulated people’s

busy lifestyles. I think support from corporate America has declined over the years. Again, bringing a mobile operation into an

organization obviously takes time away from the job. So there has

been less interest from corporate America in supporting the community blood program. I know in our community, this is an area

we are trying to focus on very significantly, again in order to increase getting the donors in the door.

Again, the other end of the spectrum is increased usage. We have

seen at least in our community, a tremendous increase in blood

products. Again, it goes back to procedures like more aggressive

therapy for cancer treatment, transplants, traumas. They are able

to get patients to hospitals much more quickly now because of air

care support. Again, the likelihood of saving that person’s life increases. But along with that comes the usage of blood and blood

components. So I think all of those factors contribute to the shortages we are seeing.

Mr. GREEN. Thank you, Mr. Chairman. I would just like to ask

Ms. Fredrick, and Dr. Bianco also, if they would just address that

sometime in other questions.

Ms. FREDRICK. I would say to you, for instance in Houston, like

many of our urban centers, the medical intensity of the procedures

that go on in our urban areas, this is where people come to have

bone marrow transplants, open heart surgery. So you have a great

need in the large urban areas of this country in the use of blood,

and the population not able to meet all of those needs. So in many

large areas, Houston to be one, not only does the local community

support the blood supply, but actually communities throughout the

country also support the blood supply.

The other issue around that is our urban centers tend to be very

diverse. We need to spend more time, more effort, in reaching out

to all the different populations we have in our communities, the

Hispanic population, the African American population, youth. That

is a job we need to think more about, reaching different groups to

encourage blood donation, because we are becoming a more diverse

community, not less so.

Mr. BIANCO. Just to add a number to what Jackie just mentioned, Gulf Coast Regional Blood Center in Houston had an increase of 15 percent in demand for blood last year.

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Mr. GREEN. Thank you, Mr. Chairman. I can also share the doctor’s concern because of the economy in Texas and people do spend

a great deal of time, maybe a long weekend in Mexico, the west

coast of Mexico, and that fear, I can understand that may be something we need to look at. Thank you, Mr. Chairman.

Mr. UPTON. Thank you. I do want to make sure that the record

is correct, too, when I talked about tatoos. It is only if you have

received a tatoo in the last year. Again, I don’t have any.

You have heard these buzzers. We have a vote on the House

floor. So we are going to temporarily adjourn for about 15 minutes

and then come back. It will be about a quarter of.

[Brief recess.]

Mr. UPTON. I think we are okay for a little while. We don’t have

votes for another hour.

At this point, I yield to a member of the subcommittee, Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman. Let me begin by asking

Dr. Wilkinson, as a lay person, a reformed lawyer, I don’t know a

lot about medicine, but I think there is a perception out there

among the public that when you give blood, a lot of people don’t

want to give it unless there is an emergency, and then you can just

run down there and give it. As was pointed out in the speakers’

testimony, that is not always the case.

Can you quickly, because I want to ask other panelists a couple

of questions, tell us the timeframe involved and sort of walk us

through? If you go and give blood, are you tested first to see if you

are acceptable, and then do they have to test the blood? How quickly can that be done?

Ms. WILKINSON. We don’t pretest the blood. But let’s say you decide you want to give blood; you come to the neighborhood blood

center, and you will be asked to give some demographic information and then you will be given a health history form. This is the

questionnaire that Mr. Upton referred to, that I guess can appear

somewhat long to someone who may not have gone through the

process before.

Typically, a lot of blood centers will have a part of the form that

is self-administered and ask general health questions about you as

a donor. It will ask for medications you have been on. It will ask

about any systemic diseases that you might possibly have that

would disqualify you as a donor.

I want to emphasize that all of this obviously is intended to protect the recipient; but there are some reasons that the questions

are being asked, in fact, to protect the donor. So we don’t draw

blood when it is inappropriate for you as the donor.

Mr. BRYANT. I guess the real point of my question: How long

would it take if you had that emergency and if you are relying on

that, then I can run in and give blood—how long would it take to

get that blood if it were acceptable to the recipient?

Ms. WILKINSON. So it is available for distribution, it takes approximately 2 days.

Mr. BRYANT. That is a point I wanted to make. We have an audience that may be watching on television, and the fact is, it is not

just a matter of walking down, taking your blood out of the body

and giving it to someone else.

133

Ms. WILKINSON. That is exactly right. From the day of donation,

your unit goes through a number of test procedures with NAT. The

turnaround time, most typically, blood centers are releasing products on the second day.

Mr. BRYANT. Dr. Bianco, you make some excellent points I think

in terms of how we think of things in Washington, too. I think this

panel has been really good on the practical side, kind of what I describe as where the rubber meets the road. This is where it happens. But you make some good recommendations. I wanted to

quickly read those and see particularly if Ms. Fredrick or Dr.

Wilkinson, anybody from the professional standpoint—certainly the

Sperrys have an experience personally—but from a professional

standpoint, if you have any disagreement.

I think the five points you make that we ought to consider in

Washington are having HHS take a stronger position on voluntary

blood donation and encouragement. Number 2, focusing the FDA

on demonstrated safety risk. Number 3, using science-based decisions in making the determinations on whether to have these restrictions in place or not. I think that is very good, using sound

science. Number 4, ensuring adequate representation of the volunteer blood community and their products advisory committee,

which I think again is a very strong and ought to be an acceptable

recommendation on your part. I think someone ought to have a

presence on that panel and have input. And the fifth, assuring adequate HCFA reimbursement for measures that increase safety and

availability of the overall blood supply.

The trends are down in this country for all these reasons we

have talked about, and it is time the government, the Federal Government, took notice of this. I think, again, those five recommendations are very strong, and I just wondered if Ms. Fredrick or Dr.

Wilkinson—I know, Dr. Bianco, you feel that way or you wouldn’t

have made it. Do you all have any comments?

Ms. FREDRICK. Yes, I think we very much support what Celso

said. We would also encourage the need to increase the funding

and the intellectual capital we spend on this issue.

If you look at the great progress we have made in safety in this

country, it has come at a financial investment and an investment

of experts, intellectual investments. We would like to see that same

sort of investment now made in availability to draw on the partnership between the private sector and the public sector, government

and blood centers, to really solve the issue of availability.

Ms. WILKINSON. I would certainly concur with Celso’s five recommendations. Again, I think it is very important that we emphasize some issues about educating the public on the need for blood

donation and how in fact those products are used; the real patients,

in fact, whose lives are changed by receiving that product from an

altruistic donor.

Mr. BRYANT. If I may make one comment to follow up on my first

comment to Dr. Wilson, there is a perception in the public if an

emergency comes up, a shooting or the bridge collapses, that we

can all run down there and give blood, but in fact there is a delay

of up to 2 days before that blood can actually be used, and you

have to have that blood in the bank, so to speak.

Ms. WILKINSON. That is correct.

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Mr. BRYANT. Literally and figuratively.

Mr. BIANCO. The word ‘‘bank’’ is what gives a false impression.

It is a feeling people have that we open the door and it is all there,

sitting on the shelf. It is not a bank, really. It is a pipeline. It is

coming in every day, it is going out every day, and it doesn’t last

too long. A platelet donation we can use within 5 days. The maximum life for a unit of red cells is 42 days. So they are very shortlived products.

Mr. BRYANT. Thank you.

Mr. UPTON. Mr. Whitfield.

Mr. WHITFIELD. Thank you, Mr. Chairman, and I apologize for

being late and not hearing your testimony, although I did have an

opportunity to read some of it. But the area that I just wanted to

focus on briefly, you had talked about in your testimony, I guess

it was Dr. Bianco, about the consensus development processes at

FDA, and I had the impression that your view is that they are not

operating with consensus development as it relates to blood.

Would you elaborate on that just a little bit?

Mr. BIANCO. Yes. The relationship of blood centers—and I can

understand historically why it happened, it all relates to the AIDS

crisis—was during many years an adversarial relationship. On the

other hand, I think that we have sufficient expertise within the

blood transfusion community in which we can sit down around the

table and make some very reasonable decisions.

I think there are many examples that come from other agencies

of the Federal Government, for instance the Energy Department,

and the decisions about pollution standards and all that, that were

achieved in terms that were much better for the American population, because everybody sat around the table, saw what is possible to do, and instead of just rules that were issued continuously,

trying to control the process and sometimes a little bit out of focus.

They were in focus a few years ago, but now the issues are different. So I think that if there was more interaction we would be

more successful in reaching that.

Mr. WHITFIELD. Is there anyone else who would like to comment

on that general area?

This Blood Products Advisory Committee, that is a committee at

FDA; is that correct?

Ms. WILKINSON. Yes.

Mr. WHITFIELD. Are blood centers represented on that?

Mr. BIANCO. Currently there are no blood center members sitting

on the committee. It used to be the tradition that one or two representatives of blood centers sat in the committee. Currently there

are physicians, there are scientists, but there are no blood center

persons.

Mr. WHITFIELD. Who appoints those members to that committee?

Mr. BIANCO. FDA. The center for Biologic Evaluation and Research.

Mr. WHITFIELD. Why would there not be a representative of the

blood centers on there?

Mr. BIANCO. Again, I believe this is a concern that comes from

the AIDS tragedy. It was a concern at one point in the early days

in which there was a feeling that FDA was too close to the blood

banking community and may not—by being too close, may not have

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been as vigilant as they should be. So the pendulum, as somebody

said, swung the other way, and so there has been a very big separation.

So the committee was reconstituted in 1995 and the previous

committee was dissolved, reconstituted, and from that point on,

there were several representatives from advocacy groups like hemophilia groups, but there were no representatives of the blood banking community.

Mr. WHITFIELD. So you feel like it has gone too far the other way

now?

Mr. BIANCO. That is what I said in my testimony, it is just a reasonable balance.

Mr. WHITFIELD. There was an example that someone gave about

this malaria in Mexico.

Mr. BIANCO. That is the example that I also gave. The example

is that we are concerned, obviously. We do not have a test that is

practical for malaria screening of blood donors, and there have

been for the last 20 or 30 years 1, 2, sometimes 3 cases a year,

sometimes no cases a year, among the 12 million units that are

transfused. Malaria in general is benign, but it can be fatal on occasion.

So we ask donors, in order to avoid people that could be at risk

of transmitting malaria, we ask donors if they have been in a malarial zone. And we are too strict about that in the ways we do it,

in my medical opinion; because we, for instance, had asked the

FDA to consider a change that if people were just in a resort where

there are no mosquitos, where everything is clean, they didn’t leave

at night to go walk by the forests or by the ruins near some Mexican resort, that those donors would be eligible to donate.

But there have been very strict interpretations of those rules,

and we cannot collect for a year a unit of blood from somebody that

went to a resort in Mexico, some resorts in Mexico, that are in malarial zones. There are resorts not in malarial zones.

Mr. WHITFIELD. Thank you.

Mr. UPTON. Dr. Ganske.

Mr. GANSKE. Thank you, Mr. Chairman.

I am sorry I wasn’t here for your presentation. I had a meeting

with the Speaker. So I may ask some questions that have been

asked before, but I think it is useful to go through some of this.

I want to talk first about safety. I guess I would leave this for

anyone on the panel to answer. But because there is a window for

sero conversion for a number of diseases, what is the chance that

a unit of blood could have the AIDS virus in it, but the test be negative?

Mr. BIANCO. The window period with the test, the officially sanctioned test that we have today for HIV, is a window of 16 days between the date the average person is infected and the date when

the virus appears in the circulation, we can detect it by the test.

With the introduction of the NAT test, that window will be reduced to 11 days.

Now, in the first 10, 11 days of the infection, the virus is not in

the circulation, it is not in the blood. It is usually in the lymph

nodes, starting to replicate. So the NAT testing will bring us the

closest we can to closing that window.

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The risk before the NAT testing, derived from some very serious

national studies, is 1 in 676,000. After the NAT testing, we don’t

have numbers measured, and the NAT testing is done under a research protocol, so we don’t have a final figure, but we assume that

will be way below 1 in a million.

Mr. GANSKE. How about hepatitis?

Mr. BIANCO. For hepatitis C, the window period is very long with

the antibody test that we have. It is about 70 days between the

date of the infection and the day on which the person develops the

antibodies that we can detect. Again, NAT testing here is very useful because the viral load, the number of viral particles in the circulation, increases very rapidly, so the NAT testing in the format

we are doing now in the research mode can reduce that window to

about 2 weeks.

Mr. GANSKE. But that is in the experimental stage. That is not

routinely being done?

Mr. BIANCO. It is being routinely done under our experimental

protocol, an IND protocol approved by FDA. But the test is not yet

licensed by FDA, but it is being done by the vast majority of the

blood centers in the country.

Mr. GANSKE. What percentage of units of blood are tested that

way before they go to a patient?

Mr. BIANCO. I would say way over 90 percent.

Mr. GANSKE. So we have a chance in 1 in 676,000 for HIV or for

hepatitis?

Mr. BIANCO. We had a chance of 1 in 103,000. Now we believe

it is again close to 1 in 600,000 to 1 in 1,000,000 after the NAT

test.

Mr. GANSKE. Have there been documented cases in England or

anywhere for the transmission of so-called mad cow disease

through blood transfusion?

Mr. BIANCO. No.

Ms. WILKINSON. No.

Mr. GANSKE. So do you agree with the ban on utilizing units of

blood from people who spent a certain period of time in England?

Mr. BIANCO. No, I do not. I do not believe there is evidence, scientific evidence, that indicates that there is risk.

Mr. GANSKE. Does anyone else on the panel want to comment on

that?

Ms. WILKINSON. I agree with what Dr. Bianco just said. It is a

theoretical risk only.

Mr. GANSKE. Does anyone pay for blood today? Do any of the

blood collecting organizations pay somebody to donate blood?

Mr. BIANCO. Not in the whole blood sector. All donors in the

AABB, American Red Cross, America’s Blood Centers, are volunteer blood donors from the community, and that is why it is tough.

The carrot is what we can do to their hearts and not the dollar bill.

Mr. GANSKE. How long has that policy been in effect?

Mr. BIANCO. The policy started effectively in the country in the

late sixties and spread all over, so I would say by the mid-to-late

1970s, early 1980s, 100 percent of the whole blood collection.

Mr. GANSKE. How about plasma?

Mr. BIANCO. Plasma for the manufacturer of plasma products is

collected from paid donors. But the plasma industry has a number

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of safety measures, and some that we cannot use, like viral inactivation of the product, that guarantees safety.

Mr. GANSKE. Okay. And then my final question would be, and

this would be for the entire panel, what is the single thing that

government could do that would help increase blood donations? If

we could start with Ms. Fredrick?

Ms. FREDRICK. I think the single thing government could do is

increase the funding available to look at donor motivation studies,

to understand the data and information on the blood supply, blood

utilization in particular. We can probably get a lot of the data on

blood collection because we are collectors, but in terms of how the

blood is being used, projections into the future on how that is going

to change is critical. Then I think to serve as a partner with us,

bringing in private industry and the private sector to really address this issue with the same expertise that we have in corporate

America to address other issues with regards to public.

Mr. BIANCO. I believe that Congress and the Federal Government

can help us with leadership and resources. The moment that you,

Mr. Upton, go and donate blood, you are sending a message. The

moment government officials talk about blood donation, they are

sending a message. They are making blood a new priority.

The second thing is resources. Because of all the change in the

health care system, we have limited resources at the present time

and we have to focus our resources on the safety issues. The piece

of the pie that we always dedicated to the recruitment of blood donors is shrinking. Very often we know what to do. We have people

that for 30 years in my organization are experts at blood collection,

going to places, convincing people, raising their spirits toward donation and events, but we don’t have the resources.

Mr. GANSKE. Mr. or Mrs. Sperry, do you have a suggestion?

Mrs. SPERRY. I would like to comment. I appreciated Mr. Upton’s

remark in putting together a race or competition between them,

and that puts a message that even though as every person has a

busy life, Congressmen as well too, but they are taking their time

to make that effort and go and give blood and to save a life. So to

me that is the most important thing, is that if they can show yourselves doing that, that maybe the ordinary American person can

look at themselves and say that I can make that same time as well.

So I appreciate that effort.

Mr. GANSKE. So Congressmen who are experts at public relations

can contribute.

Dr. Wilkinson?

Ms. WILKINSON. Well, I really support everything that everyone

at the table has previously said. Again, I think it is a matter of

making the public aware of the need, having the public understand

what is involved in the donation process, and the recipients at the

end of that process.

I can’t stress enough the resources issue. This has really become

very critical to all of us, not only the blood suppliers, but the hospital transfusion services that are involved in issuing these products to the patient. The reimbursement and resource issue is a

large one.

Mr. GANSKE. Thank you.

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Mr. UPTON. Thank you, Dr. Ganske. I just want to note for the

record that as we think about this competition in January, that two

schools in Michigan actually do this routinely. Western Michigan

University, which is in Kalamazoo, my district, and Central Michigan University, two terrific teaching universities in terms of educating teachers and putting them into the field, collected more than

1,000 units; in fact, I think it was 1,500 units were collected in the

blood drive competition between those two schools. So we have a

big challenge ahead of us on Capitol Hill in January.

Ms. Fredrick, you indicated in response to Dr. Ganske’s question

about the money that NIH is going to be spending to increase donors, and at an earlier hearing, I don’t remember if it was the first

or second one we talked about, NIH being given $1.8 million, almost $2 million to look into increasing the number of donors. So

we look forward to hearing from NIH at some time in the future

with regard to what exactly they propose and whether those reforms or procedures are implemented, and in fact how that will be

impacted. Particularly with the testimony that we heard at an earlier panel, an earlier day, from the NBDRC—is that right—yes,

great acronym—but particularly as they get into monthly reports

that they are going to be making available to this committee as

well as to private sector folks and you all too, we will really have

a fairly good handle, I think, in terms of the need and the donor

base and exactly where we are, which we don’t have today.

The question that I have—actually a number of questions. We

will see when this timer runs out before we move along. I have the

blood shortages and related articles, excerpts from Regulatory

Daily Report for the period 10-13-99, to October 13 through 5-12—

it must be 10-13-98, I will bet, through 5-12-99. Virtually every region of the country they talk about a shortage. It is alphabetical.

So it is Alabama to California, Connecticut, Wyoming and South

Carolina; specifically the regions. Michigan is included here as

well, sadly; Detroit is earmarked and a number of things, southeastern Michigan.

How is this report compiled? I am interested in how is this report

put together, and when this happens. And I know Richard Burr,

the vice chairman of this subcommittee, represents North Carolina,

and one of the tragedies with Hurricane Floyd, not only did they

have a large part of North Carolina maybe still under water, a real

hardship for thousands of Americans, but one of the side lights

that Mr. Burr related to me was that, in fact, a number of blood

drives were cancelled because of the flooding, and therefore you

could imagine, a number of the surgeries were cancelled as well,

whether they be—certainly elective, but maybe even emergency.

How do your organizations—I will be interested really from all

three of you here—react? How does this system work? How do you

identify before it is too late, and how is it that you actually take

blood from one region that has a surplus and measure that and

make sure that it gets to the region that does not? Ms. Fredrick?

Walk us through this a little bit.

Ms. FREDRICK. Thank you. The way it works in the Red Cross,

and I suspect we are a little bit different than the other organizations because we are in fact a self-contained organization, we have

something called the National Inventory Management System,

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NIMS, or the hub. The hub is in St. Louis, and it is actually a

physical location where we can store excess blood from around the

country. It is also a virtual inventory. Daily, our regions can report

in their inventory levels. So on a weekly basis, I actually get a report, by region, that will show what the blood supply is in every

region by blood type.

What we do on a daily basis essentially is look at where the

blood is needed and literally say, ‘‘St. Paul, we need you to send

blood to Detroit; this much at this time.’’

In the case of Hurricane Floyd, to give you an example of the fragility of the blood supply, we lost 10,000 donations in a 48-hour period, essentially from Daytona Beach up through, in fact, Baltimore.

To give you an example, 10,000 units is what a whole large hospital might use in a year’s worth of time. What we did is we essentially activated our national inventory system; 8,500 units went

from all of our blood regions that had blood into the five blood regions. We did it ahead of time because we have an early warning

system for disasters.

So literally we moved blood by telephone and computers, knowing where the excesses are and where the needs are. We also have

a system called production planning that will actually take that

down to the daily blood draw at a region and what will be made.

So that is how we move it.

Mr. UPTON. You move it by Postal Service, by UPS, by Federal

Express?

Ms. FREDRICK. Federal Express and UPS. Generally it is a 24

hour—we need overnight service. So where we have to fly it, it is

overnight. Now, we are lucky in that a lot of times we can drive

it, like from Lansing to Detroit, for example. But, yes, we rely essentially on commercial carriers.

Now, last January, as you and I were in Michigan, the problem

was when the airport was closed, the airplanes couldn’t land.

Mr. UPTON. Even people at the airport had trouble.

Ms. FREDRICK. So in that case, you go by land in whatever way

you can. Most of the natural disasters we can anticipate. So you

move blood ahead of time.

Mr. UPTON. Dr. Bianco, would you like to comment?

Mr. BIANCO. Yes. Our system, we are 73 independent blood centers, but we have a very cohesive group, and through ABC we do

a lot of what we call resource sharing. We are actually launching

in 2 weeks an Internet-based resource sharing, so the access and

the needs are posted on the Internet and the exchanges—currently

the system is done by fax.

But essentially, yes, as our members in Florida are having troubles because of the lack of collections and all that, members in

other areas will try to supply their needs and help them by shipping blood, but sometimes not really excess. Sometimes we all see

the need is desperate in some places and we will cut down on a

little bit of our supply to be able to help provide assistance.

Mr. UPTON. Do you assess that every week, or more often?

Mr. BIANCO. The system is not assessed. It is a voluntary system,

and it is not assessed. So here what happens is that people will voluntarily part with a portion of their blood supply, and certainly

140

they will guarantee the needs of their community before they will

ship some out. So not always, that resource sharing compensates

for deficiencies in other areas.

Mr. UPTON. Dr. Wilkinson?

Ms. WILKINSON. The AABB has a similar system, the National

Blood Exchange. Again, people who have excess inventory will post

that inventory through the exchange and people that have a need

will query the exchange to see if blood is available.

I would like to make a point to the subcommittee that people in

blood centers typically do this on an informal basis as well. They

typically know colleagues in other blood centers and they contact

them on an individual basis to see if excess blood might be available for purchase.

One of the things that at least I have noticed over time, and

maybe Jackie also might want to comment on this also, is finding

blood to purchase has become increasingly difficult. Typically in the

country there were centers that you could rely on almost 100 percent to have some excess blood that would be available for sale and

purchase in times of need. Those resources have gotten to be much

less. And again, trying to find blood and resource share, this very

valuable resource has become increasingly difficult.

Mr. UPTON. I ask for unanimous consent that Mr. Ganske can

ask a quick question before we go to Mr. Bryant.

Mr. GANSKE. Thank you, Mr. Chairman. I’m assuming that nobody has asked a question about hemochromatosis patients, so I

would like to get your testimony on this. First of all, why don’t we

go with Dr. Bianco. Can you describe what hemochromatosis is and

how patients with that require frequent blood removal and whether

then, in fact, this could be a blood supply source, and is there scientific data as to whether that would be a safe source?

Mr. BIANCO. Hemochromatosis is probably the most common genetic trait or disease in the population, the American population.

The numbers vary but it affects basically from 5 to 7 percent of the

population. And it’s a gene that is modified and that makes you absorb more iron than you should. And iron is the fundamental molecule of the hemoglobin that is in our red cells and help carry oxygen. The body doesn’t have good mechanisms of getting rid of iron.

An even so the person over the years goes accumulating iron; that

iron deposits in the lung, in the kidneys, in the liver, and in the

heart, and gradually will produce heart disease and diabetes and

a number of complications.

This is for the more serious cases, for the people that are

homozygotes that receive the same gene from mom and dad. But

there is information today, just published a few weeks ago in the

medical scientific literature, that the heterozygotes that only have

1 of the 2 chromosomes, 1 of the 2 genes also accumulate more iron

than they should.

We only see today hemochromatosis people that already have the

complications. But this is a very common gene in the population

and these people benefit from donating blood. The rules that apply

currently from FDA, even some of the standards that we have in

our organization, is that we cannot use for transfusion a blood that

is labeled what we call therapeutic phlebotomy; that is, a drawing

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that was made with the only purpose of eliminating red cells from

the individual.

We have discussed a lot and this was discussed actually at a

Blood Products Advisory Committee and the HHS Committee, that

those individuals are perfectly normal. The only thing they have is

a lot of iron. And they do not have diseases that are different than

other people. They often come to blood centers to donate or they go

to physicians’ offices and they are charged a fee for that process.

So actually what is in discussion is that if we remove the fee, so

that would be an encouragement for people not to be totally truthful in their medical history and all of that, part of that blood, those

that would be suitable, that would pass the medical history, that

would pass all the tests that we use for transfusion. And we are

all preparing submissions to FDA to attempt to do that. Now——

Mr. GANSKE. But there’s no evidence that if you gave blood from

a person with hemochromatosis that that could ever be transmitted

to the recipient.

Mr. BIANCO. Oh, it’s impossible. Because being a disease that is

determined in your genes, it is determined from the moment that

you are born, from the genes that you inherited from your parents.

Mr. GANSKE. Do you have an estimate for how many units you

might have available if you were able to use?

Mr. BIANCO. The current estimates vary tremendously and they

are all theoretical. There are estimates that we could add maybe

20,000, 30,000 units a year to 50,000 units a year in the country

and there are estimates that are much higher if these larger populations were to donate. But I can tell you this will help but is not

the solution to the supply.

Mr. GANSKE. Dr. Wilkinson, do you have any comments on that?

Ms. WILKINSON. I want to echo Dr. Bianco’s last comment. My

perception of some of the things that I’ve read has been that

hemochromatosis will make up for the shortfall that we have experienced with the deferral, the 6-month deferral with people who

have been to the United Kingdom. Again there is no scientific evidence that says in fact it will make up the shortfall. And I’m concerned that people have looked at this too much as the answer for

that shortfall.

Mr. GANSKE. Thank you. And I yield back, Mr. Chairman.

Mr. UPTON. The gentleman’s time. All right. The gentleman from

Tennessee, Mr. Bryant.

Mr. BRYANT. Thank you, Mr. Chairman. Ms. Fredrick when you

talk about the Red Cross I think moving maybe last year 650,000

units, how much is a unit?

Ms. FREDRICK. How much——

Mr. BRYANT. Is that a pint?

Ms. FREDRICK. Yes, it’s about a pint, 500 cc’s.

Mr. BRYANT. That’s what a typical donor would give. They would

donate a unit of blood, a pint of blood, when they go in to donate

one time.

Ms. FREDRICK. Correct. And that unit of blood is called the whole

blood and it is manufactured into multiple components. So you can

make a red blood cell which is used to treat anemia, platelets

which are used in bleeding disorders, cancer treatment, bone marrow transplantation, and then plasma which is also used in bleedVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00144 Fmt 6601 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
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ing disorders. So when we move about 650,000 products, those primarily are the red blood cell portion of that whole blood donation.

Mr. BRYANT. For donors, is there an age-wise, an upper end or

bottom end, is there a range that you cannot give blood; too young,

too old?

Ms. FREDRICK. There is a bottom range, and it’s 17 and older can

donate. I think every State in this country has passed State laws

that allow the 17-year-olds to give. And there really is no upper

limit per se as long as you are healthy. I know of a donor who

started donating after he was 80 years old. So as long as you meet

all of our health requirements, you can continue to donate blood.

Mr. BRYANT. I think what I get from all of your testimony is that

again, as the people who are out there, not here in Washington but

out there dealing with this problem on a daily basis, at a time

when we seem to be excluding more people from donating blood;

and the general trend for whatever reason out there, post-World

War II people were more inclined to donate blood than we are

today, being the selfish society that we’ve become. All those factors

together at a time that that is happening, and blood donations—

I think somebody said 1 percent a year—dropping 1 percent a year,

that the need for this blood is becoming more as our society ages

and as we get into more surgeries that are necessary, more elective

surgeries and these kind of things.

Do any of you have any—I know we’ve sort of talked around this

a lot, but do you have any comments on general trends or any encouragement you can give us or anything else that you would like

to not only tell this panel but to the people that might be watching

this?

Ms. FREDRICK. I think you know half the people, I believe, in this

country have experienced blood donation. So it’s not that we don’t

have a pool of wonderful, willing people who donate blood. Our

challenge is how we reach those individuals. And I think we have

to draw on all the expertise in this country to understand how you

reach individuals. Once you do, they are more than willing to donate blood. So our challenge is to determine how to do that: to use

technology to our advantage, be it the new telemarketing systems;

how you reach donors with direct mail; how you tell donors about

people like the Sperrys.

We know that people donate blood because they have a connection with the patient. And so how do we reach the donors and

make the patient relevant? I believe there are enough people willing to donate in this community and in this country. It’s our job

to bring them in and invite them in to donate.

Mr. BIANCO. I think you made a very good point in the decline

and the increase. An increase comes a lot from new medical technologies, too. There are the transplants. Bone marrow transplants

today save thousands of kids with leukemia. The rate of cure of

leukemia goes to about 73 percent today with a bone marrow transplant. It’s incredible from what it was 20 years ago. But they require a lot of blood to maintain those kids until the bone marrow

takes and grows.

And that’s the example, for instance, in Mississippi Valley Regional Blood Center, they increased their collections. But I was

looking at my notes here. They had an increase in 10.8 percent disVerDate 13-MAR-2000 14:39 Mar 15, 2000 Jkt 061962 PO 00000 Frm 00145 Fmt 6601 Sfmt 6602 E:\HEARINGS\59993.TXT pfrm07 PsN: 59993
143

tribution because of changes in their oncology programs and all of

that. In the Midwest area, that was always extremely successful in

collecting blood.

The other good point you made, people during the war had made

that commitment and that generation is not donating as often.

They can’t. They have aged. We have to bring the new generations

into the process. And the only way we’ll do that is through leadership again. There are the techniques, we need the technology, but

they need examples, they need people that they believe in so that

they can commit themselves, competing with these millions of other

things that we see every day from TV shows and all that, that are

for them sometimes more important.

Mr. BRYANT. Thank you. Dr. Wilkinson do you have a brief comment?

Ms. WILKINSON. Just finally, we live in the country that has the

best medical care in the whole world. And again the reason for that

good medical care is, as Dr. Bianco stated, our medical technology.

Again, we’re able to cure diseases that, you know, 15 years ago we

couldn’t necessarily cure. Blood is both a drug and a biologic. And

currently the only way to get this drug and biologic is from another

human being. And that’s the message that we need to get out to

others in this Nation so that they understand the need that we

have to provide this as a lifesaving drug.

Mr. UPTON. Mr. Whitfield.

Mr. WHITFIELD. Dr. Wilkinson, you had testified that the Federal

Government should support blood supply data collection and analysis. Are you primarily talking about additional funds there, or

were you referring to something else?

Ms. WILKINSON. Well, I think I’m—I think we’re seeking a mechanism for funding. Currently the National Blood Data Resource

Center took over some activities that had been performed at Harvard previously. And one of the things that we became aware of

was that currently there is no funding mechanism through, say,

National Heart, Lung and Blood Institute to fund such an organization. And we’re hoping that we can identify those mechanisms so

that we can have an ongoing stream of funding to again collect current and accurate data.

Mr. WHITFIELD. We’ve had a lot of hearings in this committee regarding organ donation and people signing cards on death that

their organs will be given to other patients. Is there a program like

that relating to blood or not?

Mr. BIANCO. No, but I think that you hit the nail on the head

in that a similar program probably could make a tremendous contribution. We are aware that the Federal Government has made an

investment. There’s a beautiful Internet site actually explaining to

people the organ donation programs. Many States have their own

programs that encourage organ donations through driver’s licenses,

through other things. But again a question of awareness. It’s a

question of overcoming an initial resistance and maybe a little bit

of anxiety about going to a blood center to donate a pint of blood.

But at the moment they overcome, just at the end of that donation,

you feel so elated that you did something great. But that is—that

similarity between the two programs is remarkable.

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Mr. WHITFIELD. But there is no organized blood donation program.

Mr. BIANCO. Of this type, no, not yet.

Mr. WHITFIELD. How many blood types are there, by the way?

Mr. BIANCO. There are many blood types but the fundamental

blood types are the four types, A, B, AB, and O. And then among

those, there is the RH type. Each one of them can be positive or

negative. The most frequent blood type is the type O. But that’s the

universal type that is the blood that can be administered to every

other person. The rarest actually is the type AB, this—a certain

type that Sperry, that Kirkland had. But Kirkland could have—he

is the universal recipient—he could have received any unit of blood

available of a matched RH type.

Mr. WHITFIELD. I yield back.

Mr. UPTON. They say round three. The United States writes the

books on regulation and safety of blood supply. Would you not

agree that our testing and our distribution system is second to

none, and other countries would carefully watch what we do in

terms of what we do? Would any of you disagree with that statement?

Dr. Bianco.

Mr. BIANCO. I will not entirely disagree, but I think that in recent years we have been so concerned about the safety of everything, that for instance Europe has introduced task modifications,

equipment, much before we did.

Mr. UPTON. Did they have the NAT test before we did in place?

Mr. BIANCO. NAT was—not before we did. It was more or less

simultaneous. But for instance, the latest generation of the hepatitis C virus antibody test was in their blood centers about at least

2 years before it was in our blood centers. And certainly they do

not have the rigorous demands that FDA makes of the manufacturers. But sometimes these processes could have been speeded up a

little bit.

Mr. UPTON. Now, as I understand it, we have about 3 dozen

deaths a year in this country because of errors that are made in

the system. Is that about right? That’s about the average?

Mr. BIANCO. The average because of errors that are fatalities is

about 18 a year.

Mr. UPTON. Eighteen a year. And how would you describe those

instances of fatalities? Would you say they’re all clerical, that they

might——

Mr. BIANCO. Those that I’m referring to——

Mr. UPTON. Mislabeled blood, from AB to O or whatever it might

be, is that virtually the entire system would be mislabeling.

Mr. BIANCO. For those it’s most—it was mislabeling, as you said,

or the sample is collected from the wrong patient or the unit is

hung on the wrong patient. That is a failure of identification.

Mr. UPTON. So they would list the wrong donor, then it would

be——

Mr. BIANCO. Mistype; it would be the wrong type. There was a

study that was performed in New York State in 1991 by the State

Department of Health, using their reporting system, in which 1 in

12,000 units in the State in that year had been transfused to an

unintended recipient.

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Mr. UPTON. Really; 1 in 12,000.

Mr. BIANCO. Without fatalities in most of them because of the

universal types, but the error occurred.

Mr. UPTON. Right. Now, your facilities that each of you represent, are they—they’re all licensed; is that correct?

Ms. WILKINSON. Yes.

Mr. UPTON. They’re routinely inspected; right?

Mr. BIANCO. Right.

Mr. UPTON. And for errors, they’re promptly reported, and I

would imagine that those errors, when and if they occur, would be

because they were mislabeled. Is that right or not? What type of

errors would you see and notice that would be moved up the line?

Ms. WILKINSON. You could really have a variety of errors. I

mean, labeling could be one of the errors; but you might have some

errors that were related to testing, errors that might have been related to the manufacturing process. I mean, there’s a whole gamut

of things that might be considered an error and reportable to the

FDA.

Mr. BIANCO. Actually the major number from what I recall the

statistics—and FDA has those statistics available—is what we call

post-transfusion—post-donation communications, when we ask the

donor to call us back if they feel something or if there is something

wrong. And I would say that about half of the reports that we

made is because somebody says, ‘‘Oh, I went home and I realized

that I went to a malarial area,’’ and we’ll pull those units and an

error is defined or accident is defined by FDA as a unit that left

our facility and that was not suitable for transfusion.

Most of the errors that are reported are errors that involve violation of some small rule, and they don’t really represent a risk to

the recipient. But some of them are because they were mislabled,

there was some error in the identification or somebody. But that’s

the nature of the error reporting. But the error reporting forces us

to study what was the cause of the error, forces us to go review.

And actually we have to submit to FDA, together with the error report and general information about how we investigated the error,

and what we did to prevent it from occurring in the future.

Mr. UPTON. I don’t know, Ms. Fredrick, if you wanted to add anything to that or not.

Ms. FREDRICK. No, I think Celso accurately described it. I think

embedded underneath the accident and error reporting system

that’s really a requirement by FDA, I’m sure most of us have other

surveillance systems that are designed to detect what we call event

aberrations much earlier than the error and accident reporting system. So I think in this country, we’ve been very vigilant about

building those systems in place, accumulating that data, even as

Celso said, using it to actually improve the system.

Mr. UPTON. Let me ask one question, then I will yield to Mr.

Bryant. When I gave blood last week and there was a comprehensive checklist that I circled yes or no based on what the question

was, and the attendant there went through it all, and a couple

questions I left unanswered or I had a question, it was very carefully gone through as to whether I was eligible or not.

Dr. Wilkinson, Dr. Bianco, when folks—since I did it at my local

Red Cross facility, is your check list identical? Is it virtually the

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same? Are there some big differences? I mean, how is it that

the——

Mr. BIANCO. It’s virtually the same. There may be changes in

words, there may be changes in——

Mr. UPTON. But you make the same sweeping test, then.

Mr. BIANCO. All are defined both by industry standards that actually are helped by AABB and by FDA guidances. And so all will

ask about the similar subjects in a similar way in order to obtain

the same information.

Mr. UPTON. Dr. Wilkinson.

Ms. WILKINSON. That is correct. And any changes in a given institution’s health history questionnaire must be approved by the

FDA before implementation.

Mr. UPTON. Mr. Bryant.

Mr. BRYANT. I want to simply conclude my part of this hearing.

I certainly thank you for doing this hearing and I want to conclude

by thanking each one of you members of the panel for being here

today, obviously very competent and qualified to be here and talk

to us about this important issue.

And I will just simply tell you that what you told us, at least I

know in my case, was very insightful and most helpful to me in understanding this situation. Certainly I hope that we all as Members

of Congress and this panel, that those that may be watching this

via television have learned a lot about how simple and how safe

the process is and how much, given again today’s climate in this

country of aging of people together with the medical technology

that’s increased the need for the use of blood, the medical technology that saves lives. I know in my district, in Memphis especially, and in Nashville, we have two really tremendous medical

communities thriving, and hospitals and in other towns that I represent—I don’t want to leave anybody out—but at this time when

we need more people having that spirit of volunteerism coming out,

and certainly coming from the volunteer State of Tennessee itself,

I hope that we can certainly get our act together down there in

terms of making sure that there’s adequate blood donations made

from our State and across the country.

But again, thank you very much for your information and especially the comments on how we can work as a Congress to better

help your effort. Thank you.

Ms. WILKINSON. Thank you.

Mr. UPTON. Thank you, Mr. Bryant. I do have a couple more

questions that I would like to ask before we adjourn, assuming no

other members return.

Has HHS been in touch with any of your organizations trying to

help on public service announcements, whether it be on hepatitis

C or increasing the number of donors in a variety of different regions in the country? That’s one of the tasks that I think we

charged them with. I wondered if they’ve actually begun to make

any comment—make any contacts using your fine organizations.

Mr. BIANCO. There have been two things. There was a presentation at the latest meeting of the Blood Products Advisory Committee in which HHS presented a series of points in which what

they felt from their internal committees could be helpful actions in

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terms of increasing the blood supply. And I believe that Dr. Satcher

mentioned that here at the first hearing.

The second thing is that we were in contact with the National

Institutes of Health, the blood—National Heart, Lung and Blood

Institute. They are trying to convene a meeting in January to discuss the issues and to see how they could help. So that contact has

happened. However, I hope that through—not however—but really

I hope that through these mechanisms we will be able to obtain the

resources that will allow us to go to these types of means of public

health announcements and all that. But what we want is not just

a public health announcement, we want you and leaders to be in

those public health announcements. That’s how you are going to

help us.

Mr. UPTON. Well, I am looking forward myself to someday getting the gallon pin. And since I donated, they sent me a whole

batch of material from my local Red Cross unit and they had all

those listed, and there was even a 10-gallon pin that was awarded

in our region.

I asked the question when Dr. Satcher was here—did a fine job—

but I asked the audience that they too, like I did today—how many

people had donated, how many again then had donated in the last

year? And Dr. Satcher indicates that, Mr. Chairman, Fred—you notice I didn’t raise my hand on the second question, and that’s because I’ve been to a number of regions in the world that in fact

once you visit, you’re not allowed to donate blood, particularly from

some parts of Africa and other places. I think he mentioned Togo—

malaria-infested areas.

Other than saying I wish I could find a place that doesn’t have

mosquitos and they would stay away from me—but as we look at

malaria and as we look at what happened in New York the last

couple weeks with—I think it’s the West Nile mosquito-passed

virus, we look at perhaps a new hepatitis strain which has been

identified this past summer. We look at disease particularly I think

in Central America, called Chagas. Don’t have that in Michigan

yet.

But as you think about other bacterial contaminations, and as we

see what happened in the U.K. with mad cow disease, and the new

question now that is part of the form that all of us fill out when

we donate blood, do you see movements similar to what we saw

with mad cow disease that are going to restrict the donors or take

potential donors out of play because of these West Nile, Chagas,

those varieties of different events? Where do you see us headed toward that?

Mr. BIANCO. We are all concerned about the emergent infections

and watching it very carefully. Centers for Disease Control has

done a very nice job of surveillance and linking with all of us, including blood centers, to do that. It’s possible that some mysterious

agent 1 day comes, but fortunately all the agents that we have

seen so far have not—since AIDS—have not been threatening to

the blood supply. Chagas has been in Latin America for many hundreds of years, maybe thousands of years. It is a serious problem

in Latin American countries. And it is transmittable by transfusion. There are tests for Chagas. So if we ever saw, because of

immigration or some issue, an increase in the prevalence of Chagas

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disease in the country and there are several studies that from time

to time are done, we would have the tests, we would have the

means to control it.

West Nile fever is the person is so sick that they can’t think

about donating blood. So the temperature that they took of you as

you donated blood would have prevented such donation. But always

we have to have our eyes and ears open to a potentially emerging

threat. We are ready I think for it.

Mr. UPTON. I don’t know if you wanted to comment.

Last question I have is, as you indicated a little bit earlier, all

of your facilities are regulated and routinely inspected—the works.

Is there any reason to think that there is any blood donor facility

in this country that shouldn’t be under the same inspection guidelines that you face? I know they’re all licensed but in some cases

they’re not inspected more than every year or 2. And obviously

there are, I think, the guidelines across the State lines. If blood

crosses State lines, then it’s under the full review of the FDA. But

it’s my understanding that only about 90 percent of the facilities

in fact are. And I just wonder about that remaining 10 percent, and

I don’t know of the 18 deaths that occur routinely, dozen and half,

maybe a little bit more from time to time, I don’t know how many

of those actually come from facilities that may not be in the same

ballpark as you all in terms of fully regulated and inspected.

Ms. WILKINSON. One of the things about, say, the fatalities, regardless of whether a facility would be licensed by the Food and

Drug Administration, they would still be required to report that to

the FDA. And there would be an investigation of that accident

through their district FDA office.

Mr. UPTON. But it’s not as prompt though, right? It really is a

question of being——

Ms. WILKINSON. I really don’t know about that. I can’t speak to

that because, again, I come from a licensed facility. But again,

transfusion services typically are not licensed and many are not

registered. There is currently a memorandum of understanding between the Food and Drug Administration and HCFA again to assess those facilities. I don’t know to what extent those assessments

are actually carried out. Again, the vast majority of organizations

that are collecting blood certainly fall under the aegis of the FDA

and are evaluated on a regular basis. I believe it’s the transfusion

services that you’re speaking about that may fall through that

process.

Mr. UPTON. And it’s my understanding that transfusion deaths,

when a transfusion death occurs, it has to be reported within 72

hours.

Ms. WILKINSON. Well 24 hours telephonically and 72 hours written; yes.

Mr. UPTON. But errors not leading to deaths are.

Ms. WILKINSON. Right. Right. And those are the—that was the

genesis for the first guidance document or the first draft that we’re

still waiting for a final document on from the FDA.

Mr. UPTON. That’s one of the things this subcommittee is trying

to pursue, those regulations being put out earlier, we’re hoping

they would come into place well before the year 2001, which seems

to be about the time line that the FDA is currently embarking on.

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Ms. WILKINSON. Right.

Ms. FREDRICK. I think I want to echo what Susan said. The 18

deaths you speak of are in the transfusion service and are not

donor center deaths in the course of developing blood. But I think

it would be our feeling that anybody who provides a blood product

ought to fall under the same stringent set of guidelines. I think we

have all invested, as we said, many, many, many millions of dollars

to make sure our systems are prepared for the future and robust

enough, and we would hope that the whole blood supply fell into

those same regulations.

Mr. BIANCO. I want to support that very emphatically and say

that every patient deserves the same quality of blood no matter

where, no matter what in our country.

Mr. UPTON. Well, I don’t think you can say it better than that.

We appreciate your time this morning. I can assure you that this

subcommittee will continue to move forward in the future on hearings to make sure that we have not only adequate levels but it continues to be safe. We appreciate your leadership and your testimony. And I guess I can say that without any of my Democrats

present, that we look forward to beating them on January 4. And

this hearing is now adjourned.

[Whereupon, at 11:55 a.m., the subcommittee was adjourned.]