Control of Unsuitable Blood and Blood Components
(4/6/88)

DATE:     April 6, 1988

TO:       ALL REGISTERED BLOOD ESTABLISHMENTS

SUBJECT:  Control of Unsuitable Blood and Blood Components

FROM:     Director, Center for Biologics Evaluation and Research

A number of errors recently have resulted in the inappropriate
release of blood and blood components not suitable for
transfusion or use in the further manufacturing of injectable
products. We are requesting all blood bank directors to
immediately review procedures and employee training programs to
determine that safeguards adequate to prevent the release of
blood and blood components not meeting Food and Drug
Administration (FDA) requirements, including untested components
such as recovered plasma from autologous donors, are in place and
are equivalent to these procedures.

QUARANTINE: Blood that is collected in accordance with acceptable
procedures must be placed immediately into quarantine in
appropriate storage temperatures, pending results of testing that
will permit labeling and distribution or destruction. When
testing is complete, the blood and blood components may be
removed from quarantine storage and, if appropriate, labeled for
distribution and placed into a storage area designated for
release. All blood and blood components that, as a result of
testing or other information, are found not suitable for
transfusion or for further manufacturing must be stored in
separate quarantine from blood and blood components for which
testing has not been done and from blood and blood components
suitable for distribution. The identity of each unit quarantined
should be confirmed from the container label by a second person
to assure clerical accuracy before release of the remainder of
the batch for distribution.

The procedure by which blood and blood components are released
from quarantine for transfusion purposes or for further
manufacture should include safeguards, (e.g., two employee check
or supervisory review) to prevent inappropriate release. Blood
and blood components determined to be ineligible for release for
any purpose must be promptly quarantined for destruction. When
some blood components from a single donation are suitable for
release but others are not, the disposition record must detail
the number of components prepared and the actual disposition of
each one. Record keeping must include identification of the
person responsible for each critical step in the labeling and
release of blood and blood components including appropriate
review.

DESTRUCTION: Destruction of ALL BLOOD COMPONENTS having a single
donation number should be accomplished simultaneously. For the
unusual situation where one of the components may be suitable for
further manufacturing, e.g., recovered plasma that is anti-HBc
positive, special recording must be made to show that failure to
destroy that blood component was deliberate and distribution made
only after a second review of all testing records disclosed no
limitation on its shipment for further manufacturing. The
identity of the component, the name and address of the consignee,
and the date of shipment should be recorded.

The method of destruction of blood and blood components should be
either by total incineration or by steam under pressure at
121.5oC for at least 60 minutes.  The adequacy of sterilization
by steam under pressure (autoclaving) should be routinely
evaluated using appropriate biological indicator systems. The
record of destruction shall include the identity of each
component in the load. Proper notations regarding final
disposition of all blood and blood components quarantined must be
entered on the appropriate record after destruction is complete
or when other disposition occurs.

ERRORS AND ACCIDENTS: If any component prepared from a unit
improperly tested, not tested, or tested properly but improperly
interpreted for ABO or for infectious diseases is accidentally
labeled and released for transfusion, fractionation, reagent
production, research or other use, immediate effort must be made
to locate and quarantine all components until satisfactory
resolution occurs.

If a whole blood unit or any blood component has been transfused
prior to recognition of the error, the medical director of the
blood collection facility should be immediately notified. If the
blood is collected outside the patient's hospital blood bank,
appropriate medical staff from the collection facility should
notify the patient's hospital blood bank director who should
document in turn that the patient's physician is suitably
notified.  Thorough ana complete documentation must be made as to
these actions, including the signature of the highest level of
supervisory review, as soon as possible after the error has been
recognized.

Errors and accidents that result in shipment of unsuitable blood
and blood components must be reported to the FDA promptly by the
licensed establishment as required by Title 21, Code of Federal
Regulations, Part 600.14(a) (21 CFR600.14(a)). Registered
(including licensed) establishments that notify users and attempt
to retrieve distributed blood and blood components as described
above should notify immediately the local FDA District Office
(per 2l CFR7.46).

Questions regarding this memorandum should be addressed to: K.
Sazama, M.D., Chief, BBPL, Division of Blood and Blood Products,
301/496-0952.

                             Paul D. Parkman, M.D.