CLIA Regulatory Requirements & Documentation 3 — Questions and Answers
Question 1: Which CLIA complexity category requires the most stringent regulatory oversight and personnel requirements?
- Waived
- Moderate complexity
- High complexity (Correct answer)
- Provider-performed microscopy
Correct answer: High complexity
High complexity testing requires the most stringent CLIA requirements for personnel qualifications, QC, and quality assurance.
Question 2: Under CLIA, a laboratory's procedure manual must be reviewed and signed by the laboratory director at least how often?
- Every 6 months
- Annually (Correct answer)
- Every 2 years
- Only when procedures change
Correct answer: Annually
CLIA requires the laboratory director to review and sign the procedure manual at least annually.
Question 3: Which of the following is NOT a required element of a CLIA-compliant test procedure document?
- Principle of the procedure
- Expected turnaround time (Correct answer)
- Reference interval (normal values)
- Limitations of the method
Correct answer: Expected turnaround time
Turnaround time is not a required element of a CLIA procedure document, though principle, reference intervals, and limitations are required.
Question 4: Under CLIA, when must a laboratory notify CMS of a change in laboratory director?
- Before the change occurs
- Within 30 days of the change (Correct answer)
- Within 90 days of the change
- At the next scheduled inspection
Correct answer: Within 30 days of the change
CLIA requires laboratories to notify CMS within 30 days of a change in laboratory director.
Question 5: A CLIA-certified laboratory that intentionally refers proficiency testing samples to another laboratory for analysis is subject to which penalty?
- Warning letter only
- Fine up to $1,000
- Revocation of CLIA certificate (Correct answer)
- Mandatory retraining
Correct answer: Revocation of CLIA certificate
Referring PT samples to another laboratory for analysis is a serious violation that can result in revocation of the laboratory's CLIA certificate.
Question 6: What is the minimum number of quality control samples that must be run each day of patient testing for a quantitative test under CLIA?
- One control at any level
- Two controls at different levels (Correct answer)
- Three controls at different levels
- Four controls spanning the reportable range
Correct answer: Two controls at different levels
CLIA requires at least two levels of controls (e.g., normal and abnormal) to be run each day patient testing is performed for quantitative tests.
Question 7: Which CLIA standard requires laboratories to have a written policy addressing the handling of test results that fall outside established reference ranges?
- Personnel standards
- Proficiency testing standards
- Quality system essentials (Correct answer)
- Test system validation
Correct answer: Quality system essentials
CLIA's quality system essentials require written policies for managing critical or out-of-range results, including notification procedures.
CLIA Regulatory Requirements & Documentation 3
Which CLIA complexity category requires the most stringent regulatory oversight and personnel requirements?