Answers
04/21/1993

T93-20                                               Monica Revelle
April 21, 1993                                       (301) 443-3285

<TITLE>FDA SUSPENDS LICENSES OF SPOKANE, WASH., BLOOD BANK</TITLE>
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       FDA SUSPENDS LICENSES OF SPOKANE, WASH., BLOOD BANK

     FDA has been receiving inquiries about the suspension of the
establishment and product licenses of Inland Northwest Blood Center
in Spokane, Wash.  The suspension, issued on April 12, prohibits
the independent blood center from shipping blood and blood products
interstate.  FDA suspended the licenses because the center had
violated federal standards ensuring the safety and quality of blood
and blood components.  In a separate action, the Department of
Health, Washington State, on April 16 prohibited the blood center
from collecting blood.
     The following can be used to answer questions.
     In the course of an inspection and investigation of the blood
center from February 10 through March 31, 1993, FDA discovered
serious deficiencies in donor suitability determinations, adherence
to standard operating procedures, HIV testing issues, record
keeping and employee training.
     Among the problems uncovered were the center's acceptance of
ineligible donors who, during their medical history interview,
admitted to intravenous drug use in the past.  The blood center 
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also incorrectly interpreted results of the HIV-1 Western Blot
assay, a test designed to determine the status of donors who had
previously tested reactive with the screening test to the HIV
antibody.  It is important to note that none of these donations
tested positive for HIV or is known to have resulted in the
transfusion of HIV-infected blood.  
     As a result of these and other findings, FDA notified the
blood center that it had to take corrective actions immediately and
submit a plan for achieving full compliance, with emphasis on
establishing sound procedures for donor suitability determinations
and Western Blot testing.
     Unless immediate action is taken to correct the deficiencies,
FDA can begin the process for revoking the facility's licenses.
Under FDA's revocation procedures, the blood center could request
a public hearing before an administrative law judge to explain why
its license should not be revoked.
     The Food, Drug and Cosmetic Act requires all blood
establishments to register with FDA, which inspects them annually. 
In addition, under authority granted by the Public Health Service
Act, FDA licenses all blood centers whose products move in
interstate commerce as well as each individual blood product they
produce.
     In another recent action involving an independent blood
facility in Washington, FDA announced that a voluntary recall of
blood platelets had been undertaken by Puget Sound Blood Center in 

                                        Page 3, T93-20, Blood Bank
Seattle,  because the product was found to be contaminated with
antibodies to hepatitis C.  The center had released a unit of blood
platelets in December 1991 after an enzyme immunoassay test found
it to be negative for the antibody to hepatitis C virus.  However,
when the product was inadvertently retested the next day, the
result was positive for the same virus.  The latter finding was
confirmed by a supplemental test using the recombinant immunoblot
assay.
     Although it is not clear what caused the first test to be
negative, an internal investigation conducted immediately afterward
and an FDA follow-up investigation determined that this was an
isolated incident.
     All whole blood and blood components intended for transfusion
are tested for antibodies to the hepatitis C virus.  Only products
that are negative for antibodies to hepatitis C virus should be
used.
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