CLT Regulatory Compliance & Standards 2 — Questions and Answers
Question 1: Under CLIA '88, which laboratory test category requires the highest level of personnel qualifications and quality control?
- Waived tests
- Moderate complexity tests
- High complexity tests (Correct answer)
- Provider-performed microscopy
Correct answer: High complexity tests
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?
- 15 days
- 30 days (Correct answer)
- 45 days
- 60 days
Correct answer: 30 days
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?
- CDC
- CMS
- OSHA (Correct answer)
- FDA
Correct answer: OSHA
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?
- Quality control chart (Correct answer)
- Proficiency testing report
- Package insert
- Standard operating procedure
Correct answer: Quality control chart
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?
- CAM — Comprehensive Accreditation Manual
- CAMLAB
- The Laboratory Standards Manual
- CAMH — Comprehensive Accreditation Manual for Hospitals (Correct answer)
Correct 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.
Question 6: A laboratory's CLIA certificate of accreditation is issued for what period of time?
- 1 year
- 2 years (Correct answer)
- 3 years
- 5 years
Correct answer: 2 years
CLIA certificates of accreditation are valid for two years, after which the laboratory must be re-inspected.
Question 7: Which regulation requires laboratories to notify patients of their right to receive a copy of their test results?
- HIPAA Privacy Rule
- CLIA Final Rule 2014 (Correct answer)
- 42 CFR Part 493
- The Affordable Care Act
Correct answer: CLIA Final Rule 2014
The 2014 CLIA Final Rule amended regulations to allow patients direct access to their laboratory test reports.
CLT Regulatory Compliance & Standards 2
Under CLIA '88, which laboratory test category requires the highest level of personnel qualifications and quality control?