CLT Regulatory Compliance & Standards 3

Question 1

Under the Hazard Communication Standard (HazCom 2012), which format replaced the Material Safety Data Sheet (MSDS)?

Accepted Answer

Safety Data Sheet (SDS)

Answer

HazCom 2012 (aligned with GHS) replaced the MSDS with the standardized 16-section Safety Data Sheet (SDS).

Question 2

Which CLSI document provides guidance on the minimum volume of anticoagulant to blood ratio required for coagulation testing?

Accepted Answer

H21-A5

Answer

CLSI H21-A5 addresses collection, transport, and processing of blood specimens for coagulation testing, including tube fill requirements.

Question 3

A laboratory proficiency testing (PT) sample must be tested in the same manner as patient samples. Which action violates this requirement?

Accepted Answer

Sending PT samples to a reference lab for testing

Answer

Referring PT samples to another laboratory for analysis violates CLIA regulations requiring labs to test PT samples as they would patient samples.

Question 4

Which type of laboratory incident must be reported to the FDA under the Safe Medical Devices Act?

Accepted Answer

Device malfunction that could cause serious injury or death

Answer

The Safe Medical Devices Act requires reporting device malfunctions that could cause or contribute to serious injury or death.

Question 5

Which term describes the laboratory process of verifying that a manufacturer's reference interval is appropriate for the lab's patient population?

Accepted Answer

Reference interval verification

Answer

Reference interval verification confirms that the manufacturer's published normal range is applicable to the laboratory's specific patient population.

(CLT) Clinical Laboratory Technologist Certification Practice Test

(CLT) Clinical Laboratory Technologist Certification Practice Test

CLT Regulatory Compliance & Standards 3