ISAC Documentation and Record Keeping 3

Question 1

When a flow cytometry SOP is revised, what documentation practice is considered best for version control?

Accepted Answer

Archive the superseded version with its effective dates and retain the new version with revision history

Answer

Best practice requires archiving all superseded SOP versions with their effective date range so historical performance can be reconstructed during audits.

Question 2

In CAP (College of American Pathologists) accreditation, which documentation is required to demonstrate operator competency in flow cytometry?

Accepted Answer

Records of competency assessments performed at defined intervals (e.g., annually)

Answer

CAP requires documented competency assessments at defined intervals to verify each operator can correctly perform the tests they run.

Question 3

What does a chain-of-custody document ensure in a forensic or clinical flow cytometry specimen?

Accepted Answer

An unbroken record of who collected, handled, and transferred the specimen

Answer

Chain-of-custody documentation provides a traceable, unbroken record of specimen possession to ensure sample integrity and legal defensibility.

Question 4

Which element is NOT typically required on a flow cytometry sample requisition form?

Accepted Answer

Operator's home address

Answer

Requisition forms require patient identifiers, ordering physician, test requested, and clinical indication; personal staff details like home addresses are not included.

Question 5

When documenting a critical value (e.g., very low CD4 count) in a flow cytometry report, what additional step must be recorded?

Accepted Answer

Document notification of the ordering provider including time, date, and name of person notified

Answer

Critical values require immediate notification of the ordering provider, and the laboratory must document who was notified, when, and what was communicated.

(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 3