Diagnosis: Blood component manufacturing: Labeling
• The Code of Federal Regulations (CFR) has requirements for the labeling of blood components.
• Blood components should only be labeled after the following have taken place:
- All donation records have been reviewed and compared with all past records for accuracy and consistency.
- All holds are resolved.
- Infectious disease test results are confirmed to be negative or nonreactive.
- All quality control processes for both the product and all equipment, supplies, and reagents used in manufacturing have been completed and reviewed.
