Incident Response and Reporting Flashcards

When a cytometry laboratory discovers a near-miss event involving a mislabeled specimen, what is the FIRST action that should be taken?

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.

Which of the following best describes a 'sentinel event' in the context of cytometry laboratory incident reporting?

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.

Under CLIA regulations, which laboratory staff member bears primary responsibility for ensuring incident reports are completed and filed?

Answer: The laboratory director

CLIA designates the laboratory director as ultimately responsible for all laboratory operations, including incident documentation and response.

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?

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.

Which regulatory body requires that clinical laboratories report certain adverse events and quality systems failures as part of their accreditation requirements?

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.

A laboratory technician accidentally splashes a cell fixative containing formaldehyde on their skin. According to standard incident response protocols, what should happen FIRST?

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.

When performing root cause analysis (RCA) following a cytometry reporting error, which tool is most commonly used to systematically identify contributing factors?

Answer: Fishbone (Ishikawa) diagram

The fishbone (Ishikawa) diagram organizes potential root causes into categories (people, process, equipment, environment) to systematically identify contributing factors.