NEWS

04/22/1996



<TITLE> STATEMENT OF FDA ON CONSENT DECREE WITH BLOOD SYSTEMS,

INC./UNITED BLOOD SERVICES </TITLE>

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April 22, 1996                       Contact:  Lawrence Bachorik

                                               (301) 827-6242



                        STATEMENT OF FDA

ON CONSENT DECREE WITH BLOOD SYSTEMS, INC./UNITED BLOOD SERVICES





     Blood Systems, Inc., (BSI) today agreed in a consent decree

with the Food and Drug Administration and the Department of Justice

to a series of measures aimed at assuring the safety of the

nation's blood supply and the integrity of BSI's blood and blood

products operations.  BSI, which operates in some locations under

the name United Blood Services, collects blood at 17 licensed

facilities and multiple blood collection sites in 13 states.  

     In the consent decree, BSI agreed to improve its quality

assurance program, to strengthen its formal training program for

its employees, including the initiation of annual competency

reviews of its employees' job performance, and to assess its

management controls and organizational structure to assure

compliance with FDA requirements.  Furthermore, BSI agreed to make

improvements in its computer systems, its records management, its

systems for investigating suspected transfusion-associated

infections, its methods for deferring unsuitable donors, and its

internal audit procedures.  

     The decree, which is subject to court approval, also provides 

                             -More-                                Page 2, P96-9, Blood Systems

for a series of timetables by which BSI must make the improvements. 

After the court has approved the decree, its provisions will be

enforceable by court order.  

     The U.S. blood supply is protected by a system of overlapping

safeguards designed to prevent the release of unsuitable products. 

The failure of an individual safeguard does not automatically

translate into the release of unsafe products, but it may increase

the potential risk.  

     In announcing this agreement designed to maintain U.S. blood

safety, the FDA emphasizes that, for any patient requiring a blood

transfusion, the risk of not receiving that transfusion outweighs

the slight risk of receiving blood.  

     In recent years, the FDA has engaged in a number of regulatory

actions involving BSI.  As a result of inspections conducted at

multiple locations during 1994, the FDA in February 1995 notified

BSI of its intention to revoke the firm's license to manufacture

and distribute blood products.  Although FDA inspections conducted

in 1995 documented improvements at many BSI blood centers, the

agency's investigators have continued to find violations of blood

safety laws and regulations.  

     This consent decree is the latest in a series of actions by

the FDA to ensure the continued safety of the U.S. blood supply. 

The FDA entered into a similar agreement with the American Red

Cross in 1993.  

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