ISAC Incident Response and Reporting 2

Question 1

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

Accepted Answer

Document the event and notify the supervisor immediately

Answer

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?

Accepted Answer

An unexpected event resulting in death or serious physical harm

Answer

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?

Accepted Answer

The laboratory director

Answer

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?

Accepted Answer

Repeat the assay on a fresh aliquot and compare results

Answer

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?

Accepted Answer

The College of American Pathologists (CAP)

Answer

CAP accreditation standards require laboratories to have a formal incident reporting and corrective action system to maintain accreditation.

(ISAC) International Society for the Advancement of Cytometry Practice Test

(ISAC) International Society for the Advancement of Cytometry Practice Test

ISAC Incident Response and Reporting 2