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From: JIM@AUVM.AUVM.EDU (Jim McIntosh)
Newsgroups: sci.med.aids
Subject: FDA Press Release
Message-ID: <25090@shemp.CS.UCLA.EDU>
Date: 21 Jun 89 04:54:52 GMT
Lines: 44
Approved: aids@cs.ucla.edu
Archive-number: 1012

P89-26                                  Food and Drug Administration
For Immediate Release                   Brad Stone (301) 443-3285
June 5, 1989                            (Home) (703) 440-6042

     The Food and Drug Administration, which requires blood banks
to test for AIDS and hepatitis, today proposed that these blood
establishments and affiliated testing laboratories participate in
FDA-approved proficiency testing programs to ensure testing
accuracy.
     While most blood establishments already participate in such
a proficiency testing program, FDA's proposed regulation is
designed to make sure participation is universal and standard.
     FDA, which licenses and inspects blood establishments, has
required that they test for the presence of AIDS antibody and
hepatitis B surface antigen in all donated blood.  Consequently,
the risk of AIDS and hepatitis B contamination in the blood
supply has been greatly diminished.
     The new rule is designated to build upon this success by
requiring blood establishments and laboratories that conduct the
testing for blood establishments to demonstrate their proficiency
through FDA-approved evaluation programs.
     In proficiency testing programs, sets of samples that have
been pre-tested are sent for retesting.  The results from this
retesting are compared by the proficiency testing program center
to the original results to detect any discrepancies in the
participating blood bank's or laboratory's results.
     Under today's proposal, the proficiency testing programs
would be performed in accordance with standards established in a
recent Health Care Financing Administration proposal for ensuring
the proficiency of clinical laboratories.
     The proposed FDA regulation complements the HCFA regulation
by extending proficiency testing standards to blood
establishments and laboratories that might be exempt from HCFA's
authority.  Both regulations are part of an HHS effort to improve
the overall performance of the nation's testing laboratories.
     In the event of such a failure, FDA would work closely with
the blood establishment or laboratory to improve the quality of
its performance.  If the blood establishment or laboratory is
unable to meet an adequate level of proficiency, the agency would
take regulatory action.
     The proposal will be published in the June 6 Federal
Register.  Comments may be sent for 30 days to the FDA Dockets
Management Branch (HFA-305), Room 4-62, 5600 Fishers Lane,
Rockville, MD 20857.