ISAC Documentation and Record Keeping 2 — Questions and Answers
Question 1: Under 21 CFR Part 11, which feature is required for electronic records used in a flow cytometry lab to be considered compliant?
- Printed paper backup for every record
- Audit trail that captures all record changes with timestamp and user ID (Correct answer)
- Records stored exclusively on local hard drives
- Manual countersignature on all digital entries
Correct answer: Audit trail that captures all record changes with timestamp and user ID
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?
- Update the SOP and discard previous lot records
- Document the lot change in the run log and perform bridging validation (Correct answer)
- Notify the manufacturer only
- Continue without documentation if the reagent is from the same vendor
Correct answer: Document the lot change in the run log and perform bridging validation
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?
- ISAC
- FDA only
- CLIA (Clinical Laboratory Improvement Amendments) (Correct answer)
- OSHA
Correct answer: CLIA (Clinical Laboratory Improvement Amendments)
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?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
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?
- To track employee attendance
- To document out-of-range QC events and the actions taken to resolve them (Correct answer)
- To record reagent purchase orders
- To list upcoming instrument maintenance schedules
Correct answer: To document out-of-range QC events and the actions taken to resolve them
A corrective action log records deviations from expected QC performance and the steps taken to identify cause and restore proper function.
Question 6: In flow cytometry, what information must be included in an instrument daily startup log?
- Only the operator name
- Bead lot numbers, target values, observed values, and pass/fail status (Correct answer)
- Room temperature and humidity only
- Patient sample IDs processed that day
Correct answer: Bead lot numbers, target values, observed values, and pass/fail status
Daily startup logs must capture QC bead lot, target values, observed CV and MFI, and whether QC passed or failed to ensure instrument performance is tracked.
Question 7: Which document type establishes the specific steps an operator must follow when acquiring a lymphocyte subset panel, ensuring reproducibility?
- Corrective action report
- Standard Operating Procedure (SOP) (Correct answer)
- Audit trail log
- Training competency assessment
Correct answer: Standard Operating Procedure (SOP)
A Standard Operating Procedure defines step-by-step instructions for a specific assay, ensuring all operators perform it the same way.
ISAC Documentation and Record Keeping 2
Under 21 CFR Part 11, which feature is required for electronic records used in a flow cytometry lab to be considered compliant?