PHYSICAL FACILITIES AND
RECORDS
§ 30.40. Facilities.
The premises and equipment used by any blood bank shall meet the following minimum requirements:
(1) Provide adequate space for the following:
(i) Private and accurate examinations of individuals to determine their suitability as blood donors.
(ii) The withdrawal of blood from donors with minimal risk of contamination and equipment unrelated to blood collection.
(iii) The storage of blood or blood components pending completion of tests.
(iv) The quarantine storage of blood or blood components in a designated location pending repetition of those tests that initially gave questionable serological results.
(v) The storage of finished products prior to distribution.
(vi) The quarantine storage, handling, and disposition of products and reagents not suitable for use.
(vii) The orderly collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.
(viii) The adequate and proper performance of all steps in plasmapheresis and leukapheresis procedures.
(ix) The orderly conduction of all packaging, labeling and other finishing operations.
(x) Provide adequate lighting, ventilation and screening of open windows and doors.
(2) Refrigeration equipment and facilities shall be provided to accommodate all blood, blood products and reagents. Refrigeration equipment shall be supplied with automatic temperature recording and alarm mechanisms where required. Temperature controls shall be within the limits of current Federal regulation for storage of blood and blood products.
(3) Fire prevention and other safety factors shall meet the requirements of applicable building codes and ordinances.
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