ISAC Regulatory Compliance 2 — Questions and Answers
Question 1: Which US regulatory agency oversees the approval and post-market surveillance of flow cytometry reagents classified as in vitro diagnostic devices?
- FDA Center for Devices and Radiological Health (CDRH) (Correct answer)
- EPA Office of Pesticide Programs
- USDA Food Safety Inspection Service
- FTC Bureau of Consumer Protection
Correct answer: FDA Center for Devices and Radiological Health (CDRH)
The FDA's CDRH regulates in vitro diagnostic devices, including flow cytometry reagents, under the Federal Food, Drug, and Cosmetic Act.
Question 2: Under CLIA regulations, a laboratory performing flow cytometric immunophenotyping for clinical diagnosis must hold which level of certification?
- Certificate of Waiver
- Certificate for Provider-Performed Microscopy
- Certificate of Compliance or Accreditation (Correct answer)
- Certificate of Registration only
Correct answer: Certificate of Compliance or Accreditation
Flow cytometric immunophenotyping is classified as high-complexity testing under CLIA, requiring a Certificate of Compliance or Accreditation.
Question 3: When a clinical flow cytometry laboratory implements a new LDT (laboratory-developed test), which CAP checklist requirement mandates analytical validation before patient use?
- ALL.09.6400 — LDT verification and validation (Correct answer)
- GEN.20316 — Personnel competency
- TRM.30350 — Reagent lot change policy
- CYT.11775 — Instrument daily QC log
Correct answer: ALL.09.6400 — LDT verification and validation
CAP checklist item ALL.09.6400 specifically requires laboratories to perform analytical validation of LDTs before they are used on patient specimens.
Question 4: What does the ISO 15189 standard primarily govern in the context of a clinical flow cytometry laboratory?
- Manufacturer quality systems for reagent production
- Medical laboratory quality and competence requirements (Correct answer)
- Environmental health and safety standards
- Shipping and transport of biohazardous specimens
Correct answer: Medical laboratory quality and competence requirements
ISO 15189 specifies requirements for quality and competence of medical laboratories, covering personnel, equipment, pre-analytical, analytical, and post-analytical phases.
Question 5: A flow cytometry lab receives a proficiency testing (PT) specimen and a colleague suggests discussing the result with a peer lab before submission. What does CLIA require?
- Labs must submit PT results independently without referral or inter-lab communication (Correct answer)
- Communication is allowed if both labs use the same instrument platform
- PT specimens may be sent to a reference lab for confirmation
- CLIA has no rules about inter-lab PT communication
Correct answer: Labs must submit PT results independently without referral or inter-lab communication
CLIA prohibits referral of PT specimens to another laboratory and forbids inter-laboratory communication about PT results before the submission deadline.
Question 6: Under FDA 21 CFR Part 820 Quality System Regulation, what must a flow cytometer manufacturer maintain for each device correction or removal?
- A recall notice submitted to ISAC headquarters
- Corrective and Preventive Action (CAPA) records (Correct answer)
- Annual renewal of 510(k) clearance
- A signed waiver from the purchasing laboratory
Correct answer: Corrective and Preventive Action (CAPA) records
21 CFR Part 820 requires manufacturers to establish and maintain CAPA procedures, documenting all corrections and removals of medical devices.
Question 7: Which OSHA standard specifically requires flow cytometry laboratories to establish a written Exposure Control Plan for bloodborne pathogen risks?
- 29 CFR 1910.1200 — Hazard Communication Standard
- 29 CFR 1910.1030 — Bloodborne Pathogens Standard (Correct answer)
- 29 CFR 1910.134 — Respiratory Protection Standard
- 29 CFR 1910.1450 — Occupational Exposure to Hazardous Chemicals
Correct answer: 29 CFR 1910.1030 — Bloodborne Pathogens Standard
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) mandates a written Exposure Control Plan for labs handling human blood and body fluids.
ISAC Regulatory Compliance 2
Which US regulatory agency oversees the approval and post-market surveillance of flow cytometry reagents classified as in vitro diagnostic devices?