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 be 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 Table 2 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.
Table 2. Reagent/Solution Testing Frequency.10Reagent or Solution
| Frequency of Testing
|
Anti-human globulin
| Each day of use
|
Blood grouping reagents
| Each day of use
|
Lectins
| Each day of use
|
Antibody screening and reverse grouping cells
| Each day of use
|
Enzymes
| 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 2–8°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.
