ISAC Incident Response and Reporting 2 — Questions and Answers
Question 1: When a cytometry laboratory discovers a near-miss event involving a mislabeled specimen, what is the FIRST action that should be taken?
- Discard the specimen and request a new one
- Document the event and notify the supervisor immediately (Correct answer)
- Proceed with analysis while flagging the result
- Inform the patient directly about the labeling error
Correct answer: Document the event and notify the supervisor immediately
Near-miss events must be immediately documented and escalated to a supervisor so corrective action can be initiated before patient harm occurs.
Question 2: Which of the following best describes a 'sentinel event' in the context of cytometry laboratory incident reporting?
- A minor instrument calibration drift caught during QC
- An unexpected event resulting in death or serious physical harm (Correct answer)
- A reagent lot change requiring new validation
- A software update that temporarily halts workflow
Correct answer: An unexpected event resulting in death or serious physical harm
A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, requiring immediate investigation and response.
Question 3: Under CLIA regulations, which laboratory staff member bears primary responsibility for ensuring incident reports are completed and filed?
- The clinical laboratory scientist who discovered the incident
- The laboratory director (Correct answer)
- The instrument manufacturer's field service engineer
- The hospital compliance officer
Correct answer: The laboratory director
CLIA designates the laboratory director as ultimately responsible for all laboratory operations, including incident documentation and response.
Question 4: A flow cytometer produces an anomalous CD4/CD8 ratio inconsistent with the patient's clinical picture. After confirming instrument function is normal, what is the most appropriate next step?
- Release the result with a disclaimer note
- Repeat the assay on a fresh aliquot and compare results (Correct answer)
- Discard the result without documentation
- Immediately contact the instrument manufacturer
Correct answer: Repeat the assay on a fresh aliquot and compare results
Repeating the assay on a fresh aliquot is standard practice to determine whether an anomalous result reflects a true patient finding or a pre-analytical variable.
Question 5: Which regulatory body requires that clinical laboratories report certain adverse events and quality systems failures as part of their accreditation requirements?
- Environmental Protection Agency (EPA)
- The College of American Pathologists (CAP) (Correct answer)
- Federal Aviation Administration (FAA)
- Occupational Safety and Health Administration (OSHA)
Correct answer: The College of American Pathologists (CAP)
CAP accreditation standards require laboratories to have a formal incident reporting and corrective action system to maintain accreditation.
Question 6: A laboratory technician accidentally splashes a cell fixative containing formaldehyde on their skin. According to standard incident response protocols, what should happen FIRST?
- Complete an incident report form before seeking treatment
- Immediately rinse the affected area with copious water for at least 15 minutes (Correct answer)
- Notify risk management by email before decontaminating
- Continue working and report the exposure at end of shift
Correct answer: Immediately rinse the affected area with copious water for at least 15 minutes
Immediate decontamination—rinsing with large amounts of water—takes absolute priority over administrative steps when a chemical exposure occurs.
Question 7: When performing root cause analysis (RCA) following a cytometry reporting error, which tool is most commonly used to systematically identify contributing factors?
- Kaplan-Meier curve
- Fishbone (Ishikawa) diagram (Correct answer)
- Flow cytometry dot plot analysis
- Pareto efficiency chart
Correct answer: Fishbone (Ishikawa) diagram
The fishbone (Ishikawa) diagram organizes potential root causes into categories (people, process, equipment, environment) to systematically identify contributing factors.
ISAC Incident Response and Reporting 2
When a cytometry laboratory discovers a near-miss event involving a mislabeled specimen, what is the FIRST action that should be taken?