ISAC Regulatory Compliance 2

Question 1

Which US regulatory agency oversees the approval and post-market surveillance of flow cytometry reagents classified as in vitro diagnostic devices?

Accepted Answer

FDA Center for Devices and Radiological Health (CDRH)

Answer

EPA Office of Pesticide Programs

Answer

USDA Food Safety Inspection Service

Answer

FTC Bureau of Consumer Protection

Question 2

Under CLIA regulations, a laboratory performing flow cytometric immunophenotyping for clinical diagnosis must hold which level of certification?

Accepted Answer

Certificate of Compliance or Accreditation

Answer

Certificate of Waiver

Answer

Certificate for Provider-Performed Microscopy

Answer

Certificate of Registration only

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?

Accepted Answer

ALL.09.6400 — LDT verification and validation

Answer

GEN.20316 — Personnel competency

Answer

TRM.30350 — Reagent lot change policy

Answer

CYT.11775 — Instrument daily QC log

Question 4

What does the ISO 15189 standard primarily govern in the context of a clinical flow cytometry laboratory?

Accepted Answer

Medical laboratory quality and competence requirements

Answer

Manufacturer quality systems for reagent production

Answer

Environmental health and safety standards

Answer

Shipping and transport of biohazardous specimens

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?

Accepted Answer

Labs must submit PT results independently without referral or inter-lab communication

Answer

Communication is allowed if both labs use the same instrument platform

Answer

PT specimens may be sent to a reference lab for confirmation

Answer

CLIA has no rules about inter-lab PT communication

Question 6

Under FDA 21 CFR Part 820 Quality System Regulation, what must a flow cytometer manufacturer maintain for each device correction or removal?

Accepted Answer

Corrective and Preventive Action (CAPA) records

Answer

A recall notice submitted to ISAC headquarters

Answer

Annual renewal of 510(k) clearance

Answer

A signed waiver from the purchasing laboratory

Question 7

Which OSHA standard specifically requires flow cytometry laboratories to establish a written Exposure Control Plan for bloodborne pathogen risks?

Accepted Answer

29 CFR 1910.1030 — Bloodborne Pathogens Standard

Answer

29 CFR 1910.1200 — Hazard Communication Standard

Answer

29 CFR 1910.134 — Respiratory Protection Standard

Answer

29 CFR 1910.1450 — Occupational Exposure to Hazardous Chemicals