Facilities are again addressed in the Title 21 regulations that apply specifically to blood components (part 606). Additional regulations that were not addressed in the general regulations and would apply to any blood bank are listed below:
Section 606.40 Facilities7
Facilities shall be maintained in a clean and orderly manner and shall be of suitable size, construction, and location to facilitate adequate cleaning, maintenance, and proper operations. The facilities shall:
- Provide adequate space for the following when applicable:
- Private and accurate examinations of individuals to determine their suitability as blood donors.
- The withdrawal of blood from donors with minimal risk of contamination, or exposure to activities and equipment unrelated to blood collection.
- The storage of blood or blood components pending completion of tests.
- The quarantine storage of blood or blood components in a designated location pending repetition of those tests that initially gave questionable serological results.
- The storage of finished products prior to distribution.
- The quarantine storage, handling, and disposition of products and reagents not suitable for use.
- The orderly collection, processing, compatibility testing, storage, and distribution of blood and blood components to prevent contamination.
- The adequate and proper performance of all steps in plasmapheresis, plateletpheresis, and leukapheresis procedures.
- The orderly conduction of all packaging, labeling, and other finishing operations.
- Provide adequate lighting, ventilation, and screening of open windows and doors.
- Provide adequate, clean, and convenient handwashing facilities for personnel, and adequate, clean, and convenient toilet facilities for donors and personnel. Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphonage.
- Provide safe and sanitary disposal for the following:
- Trash and items used during the collection, processing, and compatibility testing of blood and blood components.
- Blood and blood components not suitable for use or distribution.
7. Code of Federal Regulations. Part 606-Current Good Manufacturing Practice for Blood and Blood Components, Subpart C, Section 606.40 "Facilities". Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606/subpart-C/section-606.40.
