Regulatory Compliance & Standards Flashcards
7 cards from real CLT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
Under CLIA '88, which laboratory test category requires the highest level of personnel qualifications and quality control?
Answer: High complexity tests
High complexity tests require the most stringent personnel qualifications and quality control under CLIA '88 regulations.
A laboratory receives a deficiency citation during a CAP inspection. Within how many days must a corrective action plan typically be submitted?
Answer: 30 days
CAP requires laboratories to submit a corrective action plan within 30 days of receiving a deficiency citation.
Which federal agency enforces OSHA's Bloodborne Pathogens Standard in clinical laboratories?
Answer: OSHA
OSHA (Occupational Safety and Health Administration) enforces the Bloodborne Pathogens Standard (29 CFR 1910.1030).
Which document outlines the acceptable range of performance for a laboratory test method during method validation?
Answer: Quality control chart
A quality control chart (e.g., Levey-Jennings chart) graphically displays acceptable performance ranges established during method validation.
The Joint Commission's laboratory standards are found in which accreditation manual?
Answer: CAMH — Comprehensive Accreditation Manual for Hospitals
The Joint Commission publishes laboratory standards in the Comprehensive Accreditation Manual for Hospitals (CAMH), which includes a laboratory chapter.
A laboratory's CLIA certificate of accreditation is issued for what period of time?
Answer: 2 years
CLIA certificates of accreditation are valid for two years, after which the laboratory must be re-inspected.
Which regulation requires laboratories to notify patients of their right to receive a copy of their test results?
Answer: CLIA Final Rule 2014
The 2014 CLIA Final Rule amended regulations to allow patients direct access to their laboratory test reports.