ISAC Documentation and Record Keeping 3 — Questions and Answers
Question 1: When a flow cytometry SOP is revised, what documentation practice is considered best for version control?
- Delete the old version to avoid confusion
- Archive the superseded version with its effective dates and retain the new version with revision history (Correct answer)
- Email the new version to staff without archiving
- Only update the electronic copy and discard all paper copies
Correct answer: Archive the superseded version with its effective dates and retain the new version with revision history
Best practice requires archiving all superseded SOP versions with their effective date range so historical performance can be reconstructed during audits.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?
- A signed copy of the lab employee handbook
- Records of competency assessments performed at defined intervals (e.g., annually) (Correct answer)
- Attendance at a national cytometry conference
- Passing a written exam administered by ISAC
Correct answer: Records of competency assessments performed at defined intervals (e.g., annually)
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?
- That the sample was processed within 24 hours
- An unbroken record of who collected, handled, and transferred the specimen (Correct answer)
- That the correct antibody panel was used
- Confirmation that the instrument passed QC that day
Correct answer: An unbroken record of who collected, handled, and transferred the specimen
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?
- Patient name and date of birth
- Ordering physician's name
- Operator's home address (Correct answer)
- Test ordered and clinical indication
Correct answer: Operator's home address
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?
- Only file the result in the LIS
- Document notification of the ordering provider including time, date, and name of person notified (Correct answer)
- Repeat the test before reporting
- Flag the result in red and archive it
Correct answer: Document notification of the ordering provider including time, date, and name of person notified
Critical values require immediate notification of the ordering provider, and the laboratory must document who was notified, when, and what was communicated.
Question 6: In a research flow cytometry lab, why is maintaining a detailed gating strategy document for each experiment important?
- It satisfies CLIA requirements for research labs
- It enables reproducibility and allows others to reconstruct the analysis exactly (Correct answer)
- It is required by the IRB for all studies
- It eliminates the need for raw data storage
Correct answer: It enables reproducibility and allows others to reconstruct the analysis exactly
Documenting gating strategies ensures that analyses can be reproduced by other lab members and supports data integrity in publications and regulatory submissions.
Question 7: What is the recommended action when a flow cytometry instrument fails its daily QC but patient samples have already been acquired?
- Release all results since they were acquired before failure was detected
- Document the failure, quarantine affected results, investigate root cause, and re-run samples after corrective action (Correct answer)
- Only repeat samples from immunocompromised patients
- Perform a second QC run and average the two results
Correct answer: Document the failure, quarantine affected results, investigate root cause, and re-run samples after corrective action
Failed QC requires quarantining all affected samples, investigating the cause, documenting corrective actions, and re-running samples on a validated instrument.
ISAC Documentation and Record Keeping 3
When a flow cytometry SOP is revised, what documentation practice is considered best for version control?