ISAC Documentation and Record Keeping 5

Question 1

What is the minimum information that must be recorded when a flow cytometry reagent (antibody conjugate) is opened for the first time?

Accepted Answer

Date opened, lot number, expiration date, and initials of the person opening the reagent

Answer

Opening records must capture date opened, lot number, expiration date, and operator initials to ensure reagent traceability and compliance with expiration policies.

Question 2

In a GMP (Good Manufacturing Practice) environment performing flow cytometry for cell therapy release, what is the significance of a batch record?

Accepted Answer

It is the complete, contemporaneous record of every step, material, and person involved in processing that specific batch

Answer

A batch record is a legally required, contemporaneous document capturing every action, material, and personnel decision for a specific manufacturing lot, supporting release decisions.

Question 3

When flow cytometry data files (.fcs) are the primary record for a clinical assay, which storage requirement is most critical?

Accepted Answer

Files must be backed up with access controls, version integrity checks, and retained per regulatory retention schedules

Answer

FCS files are primary data records requiring secure backup, access controls, integrity verification, and retention per CLIA/CAP or applicable regulatory timelines.

Question 4

What is the purpose of an inter-laboratory comparison program (external QA) in flow cytometry, and what must be documented?

Accepted Answer

To assess laboratory performance against peer labs; results, evaluation scores, and corrective actions for failures must be documented

Answer

External QA programs compare a lab's results to peer labs; documentation of participation, results, scores, and corrective actions for failures is required for accreditation.

Question 5

In a clinical flow cytometry lab, when must a test report be amended and what documentation is required?

Accepted Answer

When an error is discovered post-release; an amended report must be issued with clear notation of what changed, why, and when

Answer

Amended reports are required when post-release errors are identified and must clearly state what was corrected, the reason, and the amendment date to maintain transparency.

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

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

ISAC Documentation and Record Keeping 5