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

American Board of Internal Medicine (ABIM)

Answer

Joint Commission (TJC)

Answer

American Medical Association (AMA)

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

Release the product at physician discretion if no alternative is available

Answer

Retest until a passing result is obtained

Answer

Notify the patient immediately and reschedule treatment

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

Normalization

Answer

Compensation adjustment

Answer

Fluorescence minus one (FMO) gating

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

HIPAA Security Rule only

Answer

HIPAA Privacy Rule's Minimum Necessary Standard

Answer

Neither; laboratory results are exempt from HIPAA

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

To replace the need for laboratory SOPs

Answer

To serve as the manufacturer's marketing brochure

Answer

To list all off-label applications approved by the FDA

Question 6

A research laboratory uses a flow cytometer for non-clinical studies funded by the NIH. Which regulatory framework primarily governs the integrity and documentation of that research data?

Accepted Answer

NIH/HHS Good Laboratory Practice (GLP) and research integrity policies

Answer

CLIA regulations for high-complexity testing

Answer

FDA 21 CFR Part 11 for electronic records in clinical trials

Answer

ISO 17025 for testing and calibration laboratories

Question 7

When establishing a new normal reference range for a flow cytometry assay, CAP guidelines recommend a minimum of how many healthy reference individuals?

Accepted Answer

120

Answer

10

Answer

20

Answer

500