Administration, Management, Accreditation, and Regulation
Core concepts
Blood bank regulation is layered: FDA regulates blood products and CGMP; AABB Standards set operational requirements; CAP provides laboratory accreditation; FACT covers cellular therapy. The FDA requires registration, biologics license, and reporting of errors and accidents (Form FDA 3500A). Deviations and biological product deviations must be reported.
Quality systems: validation, calibration, proficiency testing, quality control (e.g., daily temperature monitoring, reagent QC), and quality assurance audits. Document control and change control are central to CGMP. Recall and look-back procedures for infectious disease markers are mandated.
Laboratory management includes personnel qualifications (director, supervisor, technologist), competency assessment, and continuing education. Legal principles: informed consent, confidentiality (HIPAA), and liability for transfusion errors. Accreditation inspections (CAP, AABB, Joint Commission) assess compliance with standards.
Traps
- Know which body sets which standard: AABB (standards), CAP (lab accreditation), FACT (cellular therapy), FDA (regulation).
- Biological product deviation reporting timelines and responsibilities.
- Quality control frequency for reagents and equipment.
Worked example
A unit of red cells is issued to the wrong patient due to a labeling error. This is a reportable biological product deviation and a transfusion error; the facility must conduct root cause analysis, notify the supplier and FDA as required, and implement corrective action.