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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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Control of Components and Reagents, continued

CFR Title 21 section 606.65 regulates how often reagents that are used for processing blood and compatibility testing must be quality control tested. This section also requires that reagents are used according to the manufacturer's instructions.
The US Code of Federal Regulations sets minimum standards for reagent potency. To ensure that this potency remains intact, a representative sample of each lot of the reagents or solutions in the chart below must be tested on a regularly scheduled basis by methods described in the facility's Standard Operating Procedures Manual to determine its capacity to perform as required.

Reagent or Solution
Frequency of Testing
Anti-human globulin
Each day of use
Blood grouping reagents
Each day of use
Each day of use
Antibody screening and reverse grouping cells
Each day of use
Each day of use
Hepatitis test reagents
Each run
Syphilis serology reagents
Each run

Reagent storage
Reagents must be used within their dating period. Supplies and reagents that do not bear an expiration date should be stored so that the oldest is used first and should be used in a manner consistent with instructions provided by the manufacturer.
Most blood grouping reagents and cells are labeled to be stored between 2 and 8°C. When blood components and reagents are stored in the same blood refrigerator, the low alarm needs to be set to activate at 2.5°C rather than 1.5°C.