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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Title 21 Part 640 Overview

Title 21 Part 640 covers additional standards for human blood and blood products, including donor requirements, detailed collection standards, donor/unit identification, testing the blood, and the criteria for the reissue of blood components. There are emergency provisions for Platelets that allow more frequent donation when the donor is donating for a specific recipient.
Part 640 discusses quality control parameters for blood and various blood components. Note that these are minimum standards. Quality control testing from the blood supplier(s) should be obtained in order to determine platelet and cryoprecipitate therapeutic doses.
Segments are required for red cell containing components in order to facilitate compatibility testing.
Storage temperatures and transport temperatures are defined and specified in this section. Transport is defined here as the time in transit from the donor center to the transfusion service and excludes transport from the transfusion service to the internal locations such, as the emergency department, the operating rooms, and outpatient clinics.