CLT Regulatory Compliance & Standards 2

Question 1

Under CLIA '88, which laboratory test category requires the highest level of personnel qualifications and quality control?

Accepted Answer

High complexity tests

Answer

High complexity tests require the most stringent personnel qualifications and quality control under CLIA '88 regulations.

Question 2

A laboratory receives a deficiency citation during a CAP inspection. Within how many days must a corrective action plan typically be submitted?

Accepted Answer

30 days

Answer

CAP requires laboratories to submit a corrective action plan within 30 days of receiving a deficiency citation.

Question 3

Which federal agency enforces OSHA's Bloodborne Pathogens Standard in clinical laboratories?

Accepted Answer

OSHA

Answer

OSHA (Occupational Safety and Health Administration) enforces the Bloodborne Pathogens Standard (29 CFR 1910.1030).

Question 4

Which document outlines the acceptable range of performance for a laboratory test method during method validation?

Accepted Answer

Quality control chart

Answer

A quality control chart (e.g., Levey-Jennings chart) graphically displays acceptable performance ranges established during method validation.

Question 5

The Joint Commission's laboratory standards are found in which accreditation manual?

Accepted Answer

CAMH — Comprehensive Accreditation Manual for Hospitals

Answer

The Joint Commission publishes laboratory standards in the Comprehensive Accreditation Manual for Hospitals (CAMH), which includes a laboratory chapter.

(CLT) Clinical Laboratory Technologist Certification Practice Test

(CLT) Clinical Laboratory Technologist Certification Practice Test

CLT Regulatory Compliance & Standards 2