ISAC Documentation and Record Keeping 2

Question 1

Under 21 CFR Part 11, which feature is required for electronic records used in a flow cytometry lab to be considered compliant?

Accepted Answer

Audit trail that captures all record changes with timestamp and user ID

Answer

21 CFR Part 11 mandates audit trails that record who made changes, what was changed, and when, ensuring data integrity for electronic records.

Question 2

When a reagent lot number changes mid-study in a clinical flow cytometry lab, what documentation action is required?

Accepted Answer

Document the lot change in the run log and perform bridging validation

Answer

A lot change requires documentation in the run log and bridging validation to confirm the new lot performs equivalently to the previous one.

Question 3

Which regulatory body specifically mandates proficiency testing documentation for clinical flow cytometry laboratories in the United States?

Accepted Answer

CLIA (Clinical Laboratory Improvement Amendments)

Answer

CLIA mandates proficiency testing and its documentation for clinical laboratories including those performing flow cytometry.

Question 4

How long must CLIA-regulated flow cytometry laboratories retain patient test records in the US?

Accepted Answer

2 years

Answer

CLIA requires retention of patient test records for a minimum of 2 years from the date of testing for most laboratory tests.

Question 5

What is the primary purpose of a corrective action log in a flow cytometry laboratory?

Accepted Answer

To document out-of-range QC events and the actions taken to resolve them

Answer

A corrective action log records deviations from expected QC performance and the steps taken to identify cause and restore proper function.

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