CLIA Laboratory Quality Systems & Compliance 2 — Questions and Answers
Question 1: Under CLIA, how long must a laboratory retain quality control records?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
CLIA requires laboratories to retain quality control records for at least 2 years.
Question 2: A laboratory's proficiency testing (PT) sample is tested by the same method used for patient samples but the result is graded as unsatisfactory. What is the FIRST required action?
- Immediately cease testing that analyte
- Investigate and document the cause of failure (Correct answer)
- Retest the PT sample using an alternative method
- Contact the PT provider for a score correction
Correct answer: Investigate and document the cause of failure
Laboratories must investigate and document the root cause of PT failure before taking corrective action.
Question 3: Which CLIA category requires the highest level of quality control and personnel qualifications?
- Waived tests
- Moderate complexity tests
- High complexity tests (Correct answer)
- Provider-performed microscopy
Correct answer: High complexity tests
High complexity testing carries the most stringent CLIA requirements for personnel, QC, and proficiency testing.
Question 4: A new analytic method is being validated before clinical use. Which parameter evaluates how closely results agree with a reference method?
- Precision
- Accuracy (Correct answer)
- Sensitivity
- Specificity
Correct answer: Accuracy
Accuracy measures agreement between the new method's results and a reference or true value.
Question 5: Under CLIA, who is responsible for the overall operation and administration of a laboratory?
- Laboratory director (Correct answer)
- Technical supervisor
- General supervisor
- Testing personnel
Correct answer: Laboratory director
The laboratory director bears ultimate responsibility for all aspects of laboratory operation under CLIA.
Question 6: A CLIA-certified lab discovers a significant discrepancy between its internal QC results and PT scores. Under the quality systems approach, which document should be created?
- A proficiency testing exemption request
- A corrective action report (Correct answer)
- A personnel competency assessment
- A new standard operating procedure
Correct answer: A corrective action report
Discrepancies between QC and PT results trigger a formal corrective action report to document findings and remediation.
Question 7: Which CLIA provision specifically allows a physician to perform certain microscopic procedures during a patient's visit?
- Waived testing exemption
- Provider-Performed Microscopy (PPM) (Correct answer)
- Moderate complexity direct billing
- Point-of-care testing waiver
Correct answer: Provider-Performed Microscopy (PPM)
Provider-Performed Microscopy (PPM) is a CLIA subcategory permitting practitioners to perform specific microscopy procedures during patient encounters.
CLIA Laboratory Quality Systems & Compliance 2
Under CLIA, how long must a laboratory retain quality control records?