[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27241]
[[Page Unknown]]
[Federal Register: November 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Consensus Development Conference on Effect of Indirect Markers of
Infectious Diseases on Blood Transfusion Safety
Notice is hereby given of the NIH Consensus Development Conference
on ``Effect of Indirect Markers of Infectious Diseases on Blood
Transfusion Safety,'' which will be held January 9-11, 1995, in the
Masur Auditorium of the National Institutes of Health, 9000 Rockville
Pike, Bethesda, Maryland 20892. The conference begins at 8:30 a.m. on
January 9 and 10 and at 9 a.m. on January 11.
In the approximately 50 years since the U.S. has had an organized
national blood collection and distribution system, an increasing number
of tests have been mandated, recommended by regulatory authorities, or
adopted voluntarily to minimize the transmission of infectious diseases
and make blood transfusion as safe as possible.
In the last 10 years alone, blood collection agencies have
implemented five new tests on all donated blood--Human Immunodeficiency
Virus (HIV) antibodies (later expanded from HIV-1 to HIV-1 and -2);
hepatitis B core antibody (HBcAb); serum alanine aminotransferare
(ALT); antibodies to Human T-cell Lymphotrophic Virus (HTLV) 1 and 2;
and, most recently, antibodies to Hepatitis C Virus (HCV). And there
are pressures to add tests for emerging diseases--most recently, for
example, Chagas' Disease.
Most of the newer tests have been improved since they were
introduced, adding to transfusion safety and reducing false positive
tests and the unnecessary loss of donors. However, several of the tests
that are now performed are not specific for the diseases they are
targeting. Some (ALT, HBcAb) were introduced as surrogates for diseases
now subject to more specific testing. Another (Serological Test for
Syphilis-STS) was introduced to protect against one disease, but is
being retained as much as a sign of lifestyle as for evidence of
disease.
The contribution some of these tests make to transfusion safety is
uncertain. This issue is important if they do not, in fact, improve
safety. It has become increasingly difficult to locate donors to
replace those lost to false positive tests, which results in more
frequent and severe blood shortages. And the cost of the tests
themselves needlessly makes blood processing and blood transfusions
more expensive.
The purpose of this consensus conference is to evaluate the
continued use of the syphilis, hepatitis B core antibody, and alanine
aminotransferase (ALT) tests, as well as to examine the process for
adding new infectious disease screening tests to improve transfusion
safety. This conference will bring together specialists from the fields
of hematology, cardiology, transfusion medicine, infectious disease,
and nursing as well as representatives from the public.
After 1\1/2\ days of presentations and audience discussion, an
independent, non-Federal consensus panel will weigh the scientific
evidence and write a draft statement that it will present to the
audience on the third day. The consensus statement will address the
following key questions:
What are the indications for the introduction of an
infectious disease screening test to improve transfusion safety and
what should be the requirements of such a test?
To what extent do the following contribute to transfusion
safety: tests for syphilis and for hepatitis B core antibody; should
they continue to be used as now or should their use be modified?
To what extent does the alanine aminotransferase (ALT)
test contribute to transfusion safety; should it continue to be used as
now or should its use be modified?
What are the appropriate ways to manage potential threats
to transfusion safety from emerging infectious diseases such as, for
example, Chagas' disease?
What are the highest priorities for research to improve
transfusion safety by reducing the transmission of infectious disease?
The primary sponsors for this conference are the National Heart,
Lung, and Blood Institute and the NIH Office of Medical Applications of
Research. The conference is cosponsored by the Transfusion Medicine
Branch of the NIH Clinical Center. This is the 99th Consensus
Development Conference held by NIH since the establishment of the
Consensus Development Program in 1977.
Advance information on the conference program and conference
registration materials may be obtained from: Debra Steward, Technical
Resources International, Inc., 3202 Tower Oaks Blvd., Suite 200,
Rockville, Maryland 20852, (301) 770-3153.
The consensus statement will be submitted for publication in
professional journals and other publications. In addition, the
consensus statement will be available beginning January 11, 1995, from
the NIH Consensus Program Information Service, P.O. Box 2577,
Kensington, Maryland 20891, phone 1-800-NIH-OMAR (1-800-644-6627).
Dated: October 26, 1994.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 94-27241 Filed 11-2-94; 8:45 am]
BILLING CODE 4140-01-M
