Quality Assurance, Regulatory Compliance, and Laboratory Management
Regulatory framework
The FDA enforces 21 CFR Parts 600, 606 (current good manufacturing practice), 610, 630 (donor eligibility), and 640 (blood products). AABB Standards and accreditation, CAP and CLIA for laboratory testing, and Joint Commission requirements for hospital transfusion services complete the picture. Understand that regulations are mandatory while standards and accreditation are voluntary but effectively required for participation. Deviations demand documented investigation, corrective and preventive action, and medical director review; fatalities must be reported to the FDA.
Quality control and process control
Reagent quality control includes testing antisera on each day of use with appropriate cells, for example anti-D against a weak D cell and a D-negative cell. Equipment requires temperature monitoring (refrigerators 1-6 C, freezers -18 C or colder, platelet incubators and agitators 20-24 C), calibration, preventive maintenance, and alarms. Proficiency testing must be performed with investigation of failures. Staff competency is assessed at defined intervals. The laboratory information system and any new method must be validated before use.
Management essentials
Record retention commonly extends to 10 years for transfusion records and longer for donor records. Internal audits, inventory management (first in, first out; older units for general use), blood utilization review by the transfusion committee, maximum surgical blood order schedules, patient identification with two independent identifiers and bedside barcode verification, and reporting of errors and near misses all fall under the blood bank manager's scope.
Traps
- Temperature limits are heavily tested: red cells 1-6 C, platelets 20-24 C with agitation, plasma -18 C or colder.
- A failed quality control run invalidates patient results from that period until corrective action and retesting occur.
- Policies, deviations, and procedure changes are approved by the medical director, not the bench technologist.
Rule of thumb: if it is not documented, it did not happen, and every deviation from procedure must be recorded, investigated, and reviewed.