CLC CLC Laboratory Accreditation & Certification Processes 1 — Questions and Answers
Question 1: Which federal law primarily governs clinical laboratory testing in the United States and requires laboratories to meet specific quality standards?
- HIPAA
- CLIA (Clinical Laboratory Improvement Amendments) (Correct answer)
- OSHA Act
- FDA Safety Act
Correct answer: CLIA (Clinical Laboratory Improvement Amendments)
CLIA (Clinical Laboratory Improvement Amendments of 1988) is the federal law that regulates all clinical laboratory testing performed on humans in the US.
Question 2: Which accrediting organization offers the most widely recognized laboratory accreditation program and is deemed by CMS to meet CLIA requirements?
- The Joint Commission (TJC)
- College of American Pathologists (CAP) (Correct answer)
- AAAHC
- DNV GL Healthcare
Correct answer: College of American Pathologists (CAP)
The College of American Pathologists (CAP) accreditation program is broadly recognized and is CMS-deemed, meaning CAP-accredited labs are considered to meet CLIA standards.
Question 3: Under CLIA, which test category requires the least regulatory oversight because it poses the lowest risk for patient harm if performed incorrectly?
- Moderate complexity
- High complexity
- Waived tests (Correct answer)
- Provider-performed microscopy
Correct answer: Waived tests
Waived tests are cleared by the FDA for home use or are simple, accurate tests with low risk for error, and require only a CLIA certificate of waiver.
Question 4: A laboratory consultant is reviewing accreditation survey findings. Which type of CAP deficiency requires an immediate corrective action plan submitted within 30 days?
- Phase I deficiency
- Phase II deficiency (Correct answer)
- Observation
- Best practice recommendation
Correct answer: Phase II deficiency
CAP Phase II deficiencies represent significant non-compliance and require a corrective action plan submitted within 30 days of the survey report.
Question 5: Which document outlines the specific standards a laboratory must meet during a CAP accreditation inspection?
- Laboratory policy manual
- CAP Checklists (Correct answer)
- CLIA certificate application
- Laboratory director's CV
Correct answer: CAP Checklists
CAP Checklists are the inspection documents used during accreditation surveys to assess compliance with specific standards across all laboratory sections.
Question 6: A laboratory pursuing ISO 15189 accreditation is primarily demonstrating competence in which area?
- Environmental health and safety
- Medical laboratory quality and competence (Correct answer)
- Pharmaceutical manufacturing
- Hospital administration
Correct answer: Medical laboratory quality and competence
ISO 15189 is an international standard specifying requirements for quality and competence in medical laboratories.
CLC CLC Laboratory Accreditation & Certification Processes 1
Which federal law primarily governs clinical laboratory testing in the United States and requires laboratories to meet specific quality standards?