ISAC Regulatory Compliance 4

Question 1

In a clinical flow cytometry lab, which proficiency testing (PT) provider is approved by CMS under CLIA for leukocyte immunophenotyping?

Accepted Answer

College of American Pathologists (CAP)

Answer

CAP is a CMS-approved PT provider for leukocyte immunophenotyping and numerous other laboratory specialties under CLIA regulations.

Question 2

A cell therapy product fails its flow cytometric viability release specification. Under GMP, what is the REQUIRED next step before dispositioning the batch?

Accepted Answer

Initiate a formal Out-of-Specification (OOS) investigation

Answer

GMP requires a formal OOS investigation to determine the root cause before any batch disposition decision can be made.

Question 3

Which term describes the process of demonstrating that a flow cytometer's measurement output is traceable to known reference standards over time?

Accepted Answer

Metrological traceability and calibration

Answer

Metrological traceability, achieved through regular calibration with reference standards, ensures that instrument measurements remain linked to internationally recognized units.

Question 4

Under HIPAA Privacy Rule, which data standard applies when a flow cytometry laboratory transmits patient result reports electronically to a physician's EHR system?

Accepted Answer

Both Privacy Rule minimum necessary and Security Rule electronic safeguards

Answer

Electronic transmission of PHI-containing lab results must comply with both the Privacy Rule (minimum necessary information) and the Security Rule (technical, administrative, and physical safeguards).

Question 5

What is the primary purpose of a Directions for Use (DFU) document required for an FDA-cleared flow cytometry reagent?

Accepted Answer

To provide the intended use, procedural instructions, and performance characteristics to guide safe and effective use

Answer

The DFU is a regulatory document that communicates the intended use, procedural steps, and validated performance data so the laboratory can use the reagent correctly and safely.

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

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

ISAC Regulatory Compliance 4