Facility Inspection & Shipping Quality Control

Upon request by the FDA, CAP, AABB or BCP, its agents and employees, the transfusion facility shall allow reasonable on-site inspection of blood storage facilities during normal business hours. They shall also allow the review and copying of the storage facility’s SOP for blood component storage and quality assurance records relating to blood component storage and handling.

Inspection of storage records is performed by BCP on an annual basis, unless the facility has current AABB certification and two consecutive years of satisfactory inspections. In these cases, the inspection is performed every two years. Results of the inspection are shared with the transfusion facility.

During the inspection, BCP employees will complete an inspection checklist when observing storage devices. There is one checklist for each temperature range:

• Storage at 20-24C: BS 983A
• Storage at 1-6C: BS 983B
• Storage at or colder than -18C: BS 983C

Twice a year (summer and winter), BCP staff perform temperature quality control on units shipped to selected facilities. The facility should follow instructions on the Datalogger Envelope, BS 334G, and return the shipment to BCP by overnight delivery as soon as possible if delivered by a non- BCP courier. (Contact Hospital Services for a Datalogger Envelope BS 334G.)