(a) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged in the collection, processing, testing, storage, distribution and administration of blood, blood components or derivatives for autogeneic or allogeneic use, and for therapeutic, prophylactic or diagnostic purposes. There shall be a written protocol for all procedures performed at the facility. Manuals shall contain a protocol for writing, maintaining and periodic review of standard operating procedures by user personnel and management staff. Procedure manuals shall have the following features:

1. (1) a standardized format;
2. (2) a system of numbering and/or entitling individual procedures;
3. (3) a clearly written description of purpose for each procedure;
4. (4) a reference section listing appropriate scientific literature;
5. (5) clearly defined areas of personnel responsibility by title;
6. (6) documented approval of procedures and procedural modifications by the director, and annual review by the director or authorized supervisor;
7. (7) instructions for the completion of reports and forms, including examples;
8. (8) effective date and date of review for each procedure; and

9. (9) a system of archiving earlier versions of procedures and forms.

   Discontinued procedure documents and forms shall be retained and be available for inspection for at least seven years. Dates of initial use and discontinuance shall be recorded.

(c) The standard operating procedure manual shall include written policies and procedures regarding the following, for activities performed at the site:

1. (1) use and maintenance of blood warming devices;
2. (2) type of infusion sets and filters for all components;
3. (3) issuance of components, which must include visual inspection prior to issuance;
4. (4) type of personnel authorized to issue components;
5. (5) for collecting facilities, obtaining blood or components from other institutions during emergency situations;
6. (6) all transfusion-related testing, prenatal testing, and neonatal testing;
7. (7) prompt evaluation of reported transfusion reactions and other adverse events;
8. (8) emergency release of uncrossmatched blood, which must include compatibility testing performed after release;
9. (9) method validation requirements;
10. (10) professional qualifications of personnel who may collect blood specimens for pretransfusion testing;
11. (11) specimen and labeling requirements for pretransfusion samples;
12. (12) release of blood and blood components to limited transfusion services and ambulance transfusion services; and
13. (13) administration of blood components, including prevention of transfusion reactions.