Section 606.100 requires standard operating procedures for blood storage and requires that the donor unit is traceable from donation to the final recipient. The required standard operating procedures included in this section that are applicable to all transfusion services laboratories are listed below.
Written standard operating procedures must include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes. These procedures must be available to personnel for use in the areas where the procedures are performed.
The written standard operating procedures must include, but are not limited to, descriptions of the following, when applicable:11
- Pretransfusion testing, where applicable, including precautions to be taken to identify accurately the recipient blood samples and crossmatched donor units.
- Procedures for investigating adverse donor and recipient reactions.
- Storage temperatures and methods of controlling storage temperatures for all blood products and reagents.
- Length of expiration dates, if any, assigned for all final products as prescribed in 610.53 of this chapter.
- Criteria for determining whether returned blood is suitable for reissue.
- Procedures used for relating a unit of blood or blood component from the donor to its final disposition.
- Quality control procedures for supplies and reagents employed in ... pretransfusion testing.
- Schedules and procedures for equipment maintenance and calibration.
- Labeling procedures, including safeguards to avoid labeling mixups.
- Procedures of plasmapheresis, plateletpheresis, and leukapheresis, if performed, including precautions to be taken to ensure reinfusion of a donor's own cells.
- Procedures for preparing recovered plasma, if performed, including details of separation, pooling, labeling, storage, and distribution.
A facility is allowed to use the standard operating procedures of the AABB, the American Red Cross, or other approved organizations, providing the requirements are as stringent as the FDA requirements.
