ISAC Incident Response and Reporting 3 — Questions and Answers
Question 1: A flow cytometry result for a pediatric patient is reported with the wrong patient identifier. This type of error is best classified as which category of laboratory incident?
- Pre-analytical error
- Analytical error
- Post-analytical error (Correct answer)
- Instrument calibration failure
Correct answer: Post-analytical error
Wrong patient identifier on a reported result is a post-analytical error because it occurs after the specimen has been analyzed and during the reporting phase.
Question 2: Which element is LEAST important to include in a formal laboratory incident report for a cytometry specimen mix-up?
- Date and time of the incident
- Names of all laboratory personnel on shift
- The laboratory's annual revenue figures (Correct answer)
- Description of immediate corrective actions taken
Correct answer: The laboratory's annual revenue figures
Financial data is irrelevant to an incident report; the focus should be on the event details, involved personnel, and corrective actions.
Question 3: In a flow cytometry laboratory, what is the primary purpose of conducting a 'failure mode and effects analysis' (FMEA) proactively?
- To rank laboratory staff performance annually
- To identify potential failure points before they cause actual incidents (Correct answer)
- To compare instrument pricing across vendors
- To satisfy billing and reimbursement documentation requirements
Correct answer: To identify potential failure points before they cause actual incidents
FMEA is a prospective risk assessment tool used to identify, prioritize, and mitigate potential failure modes before they result in patient harm or laboratory errors.
Question 4: After a critical cytometry result (e.g., blasts consistent with acute leukemia) is identified, what is the most appropriate communication action?
- Upload results to the electronic health record and wait for the clinician to review
- Directly contact the ordering physician or clinical team by phone and document the notification (Correct answer)
- Send an automated email alert and proceed to the next specimen
- Hold the result until the end of the business day for batch reporting
Correct answer: Directly contact the ordering physician or clinical team by phone and document the notification
Critical values require immediate verbal notification to the responsible clinician with documentation of who was notified, when, and what information was conveyed.
Question 5: A cytometry laboratory receives a blood sample that arrived hemolyzed and at ambient temperature after a 6-hour transit delay. What is the best course of action?
- Process the specimen and add a caveat to the report
- Reject the specimen, document the rejection reason, and notify the ordering provider to recollect (Correct answer)
- Centrifuge the specimen and proceed with immunophenotyping
- Freeze the sample for later analysis when a fresh specimen is unavailable
Correct answer: Reject the specimen, document the rejection reason, and notify the ordering provider to recollect
A specimen that is hemolyzed and temperature-compromised will yield unreliable flow cytometry results; rejection with documented reason and recollection request is the appropriate action.
Question 6: Which of the following scenarios would most likely trigger mandatory external reporting to a state health department laboratory program?
- A single pipetting error caught internally during QC
- A pattern of systematic reportable disease misclassification affecting multiple patients (Correct answer)
- An instrument malfunction corrected within one hour
- A staff member taking unscheduled leave during a busy period
Correct answer: A pattern of systematic reportable disease misclassification affecting multiple patients
Systematic errors affecting disease classification and public health reporting obligations require notification to the state health department as part of mandatory external reporting frameworks.
Question 7: When should a corrective action plan (CAP) be implemented following a laboratory incident investigation?
- Only if the incident resulted in a patient complaint
- After root cause analysis identifies contributing factors, regardless of incident severity (Correct answer)
- Exclusively for incidents involving regulatory inspectors
- Only when the same error occurs three or more times
Correct answer: After root cause analysis identifies contributing factors, regardless of incident severity
A corrective action plan should be implemented after any root cause analysis identifies contributing factors, as even low-severity incidents can reveal systemic vulnerabilities.
ISAC Incident Response and Reporting 3
A flow cytometry result for a pediatric patient is reported with the wrong patient identifier.
This type of error is best classified as which category of laboratory incident?