Quality Management, Regulatory and Safety Systems
Quality Management
QC versus QA
Quality control is the technical check on a product or test: running controls, calibrating instruments, and verifying reagent antisera daily against known cells. Quality assurance is the larger system - SOPs, document control, audits, occurrence reporting, competency assessment, proficiency testing, equipment maintenance and process improvement. Both live inside a quality management system that also covers validation and verification: validation is required for in-house or modified methods, whereas verification confirms that an FDA-cleared method performs to the manufacturer's specifications in your laboratory.
Statistical and improvement tools
Levey-Jennings charts with Westgard rules govern analytical runs: 1-3s (one point beyond 3 SD) reject; 2-2s (two consecutive points beyond the same 2 SD limit) reject; R-4s (range between two controls exceeds 4 SD) reject; 4-1s and 10x flag systematic drift. Root cause analysis is retrospective for adverse events; FMEA is prospective. PDSA/PDCA cycles drive improvement; Pareto charts prioritize problems; Ishikawa (fishbone) diagrams sort causes into people, process, equipment and environment.
Traps
Questions test corrective versus preventive action within CAPA, and confuse competency assessment intervals (initial, at 6 months, then annually) with proficiency testing. Remember that a quality indicator is a measured proxy for performance, not an audit itself, and that variance and lookback investigations are QA activities.
Worked example
A chemistry control gives values of +2.4 SD and +2.6 SD on consecutive runs at the same level. That is a 2-2s violation: reject the run, investigate (recalibrate, check reagent lot, repeat control) before reporting patient results.
Regulatory and Safety Systems
Who regulates what
FDA/CBER oversees blood establishments under 21 CFR 606 (cGMP), 610 (general biological product standards), 630 (donor screening and testing) and 640 (additional standards for blood products). AABB Standards and CAP or Joint Commission accreditation apply to the facility; CLIA/CMS certify the clinical laboratory. ISBT 128 provides global labeling, identification and traceability, and hemovigilance data flow through public health surveillance systems.
Reporting obligations
Two timelines dominate exam questions. A fatality related to blood collection or transfusion must be reported to FDA within 7 days of the event. A Biological Product Deviation Report (BPDR) is submitted within 45 days of learning that a product may be unsafe, impure, ineffective, or that a deviation occurred affecting safety, purity or potency. Donor lookback and error/accident reports also follow these channels. Internal occurrence reports are always required, even when an event is not FDA-reportable.
Occupational and transport safety
OSHA's Bloodborne Pathogens Standard requires an exposure control plan, engineering controls, personal protective equipment, the offer of hepatitis B vaccination and post-exposure evaluation. Biological shipments follow DOT/IATA rules: most clinical specimens are Category B (UN3373), while cultures are Category A. Patient and donor information is protected under HIPAA.
Traps
Mixing up 7 days (fatality) with 45 days (BPDR) is the classic error. Also distinguish registration from licensure, and remember that a failure to meet a standard is a deviation even if the unit was never transfused.
Worked example
A unit of RBCs sat at room temperature for five hours before issue and was transfused. This is a post-donation deviation affecting potency: submit a BPDR to FDA within 45 days and open an internal occurrence report.