CLIA Laboratory Quality Systems & Compliance 4 — Questions and Answers
Question 1: A laboratory performs waived testing only. Which CLIA certificate type does it need?
- Certificate of Accreditation
- Certificate of Compliance
- Certificate of Waiver (Correct answer)
- Certificate of Registration
Correct answer: Certificate of Waiver
Laboratories performing only waived tests must obtain a Certificate of Waiver under CLIA.
Question 2: Under CLIA quality systems, which post-analytic process ensures that critical values reach the ordering provider promptly?
- Delta checking
- Autoverification
- Critical value notification (Correct answer)
- Reference interval review
Correct answer: Critical value notification
Critical value notification is a post-analytic requirement to communicate life-threatening results to the responsible clinician without delay.
Question 3: Calibration verification must be performed under CLIA at minimum how often for most quantitative tests?
- Every 30 days
- Every 6 months (Correct answer)
- Every year
- Every 2 years
Correct answer: Every 6 months
CLIA mandates calibration verification at least every 6 months, or whenever certain trigger events occur, for most quantitative tests.
Question 4: A laboratory's QC chart shows a trend of 6 consecutive results progressively moving in one direction without exceeding ±2 SD. This pattern most likely indicates:
- Random error
- Systematic error or drift (Correct answer)
- Acceptable imprecision
- Inter-run variability
Correct answer: Systematic error or drift
A 6-point directional trend on a QC chart signals systematic error or reagent/calibrator drift requiring investigation.
Question 5: Which CLIA-deemed accreditation organization is specifically known for laboratory accreditation in pathology and clinical laboratory science?
- The Joint Commission (TJC)
- College of American Pathologists (CAP) (Correct answer)
- AAAHC
- DNV GL
Correct answer: College of American Pathologists (CAP)
The College of American Pathologists (CAP) is a CMS-deemed authority widely recognized for laboratory accreditation.
Question 6: When a laboratory changes its testing location to a new address, which action is required under CLIA?
- Notify the PT provider only
- Apply for a new CLIA certificate for the new location (Correct answer)
- Update the laboratory director's license
- File a variance with the state health department
Correct answer: Apply for a new CLIA certificate for the new location
CLIA certificates are site-specific, so moving to a new address requires obtaining a new certificate for that location.
Question 7: A physician's office laboratory (POL) performs moderate complexity hematology testing. Which personnel role is REQUIRED by CLIA but NOT required for waived testing sites?
- Laboratory director
- General supervisor (Correct answer)
- Testing personnel
- Clinical consultant
Correct answer: General supervisor
Moderate complexity labs must designate a general supervisor to provide day-to-day supervision, a requirement that does not apply to waived testing sites.
CLIA Laboratory Quality Systems & Compliance 4
A laboratory performs waived testing only.
Which CLIA certificate type does it need?