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

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?

Accepted Answer

Certificate of Compliance or Accreditation

Answer

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?

Accepted Answer

ALL.09.6400 — LDT verification and validation

Answer

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?

Accepted Answer

Medical laboratory quality and competence requirements

Answer

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?

Accepted Answer

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

Answer

CLIA prohibits referral of PT specimens to another laboratory and forbids inter-laboratory communication about PT results before the submission deadline.

(ISAC) International Society for the Advancement of Cytometry Practice Test

(ISAC) International Society for the Advancement of Cytometry Practice Test

ISAC Regulatory Compliance 2