CLC Professional Standards & Competencies 3 — Questions and Answers
Question 1: Which CLIA certificate level is required for laboratories performing tests classified as 'high complexity'?
- Certificate of Waiver
- Certificate for Provider-Performed Microscopy
- Certificate of Compliance (Correct answer)
- Certificate of Registration only
Correct answer: Certificate of Compliance
A Certificate of Compliance (or Accreditation) is required for laboratories performing high-complexity testing under CLIA regulations.
Question 2: A consultant recommends a laboratory implement a delta check system. The primary purpose of this quality tool is to:
- Compare results between two different analyzers
- Flag patient results that differ significantly from previous values (Correct answer)
- Monitor reagent lot-to-lot variability
- Evaluate staff competency in result reporting
Correct answer: Flag patient results that differ significantly from previous values
Delta checks compare a patient's current result with their previous result to detect potential specimen mix-ups or clinically significant changes.
Question 3: Competency assessment for laboratory testing personnel must be performed:
- Only at initial hire
- Every 5 years as required by CLIA
- At initial hire and semiannually for the first year, then annually (Correct answer)
- Quarterly for all high-complexity testers
Correct answer: At initial hire and semiannually for the first year, then annually
CLIA requires competency assessment for high-complexity testing personnel at 6 months and 12 months during the first year, then at least annually thereafter.
Question 4: Which of the following is NOT one of the six CLIA-mandated competency assessment elements?
- Direct observation of routine patient test performance
- Monitoring the recording and reporting of test results
- Evaluation of interpersonal communication skills (Correct answer)
- Review of intermediate test results or worksheets
Correct answer: Evaluation of interpersonal communication skills
The six CLIA competency elements focus on technical and procedural skills; interpersonal communication is not among the mandated elements.
Question 5: When a laboratory introduces a new quantitative test, the minimum number of samples typically required to establish analytical measurement range (AMR) is:
- 5
- 20 (Correct answer)
- 40
- 100
Correct answer: 20
Clinical laboratory guidelines (e.g., CLSI EP06) recommend a minimum of approximately 20 samples spanning the reportable range to establish AMR.
Question 6: A laboratory consultant reviewing critical value policies should verify that the policy addresses:
- The time limit for reporting critical results to responsible care providers (Correct answer)
- The cost of testing for critical analytes only
- The maximum number of critical values allowed per shift
- Mandatory repeat testing before any critical result is reported
Correct answer: The time limit for reporting critical results to responsible care providers
Accreditation standards and patient safety requirements mandate that critical values be reported to a responsible caregiver within a defined, documented time frame.
Question 7: The primary difference between validation and verification of a laboratory test method is that:
- Validation is performed by the manufacturer; verification is performed by the laboratory (Correct answer)
- Verification is more extensive than validation for new methods
- Validation requires more samples than verification in all cases
- Only verification requires documentation of results
Correct answer: Validation is performed by the manufacturer; verification is performed by the laboratory
Manufacturers perform full validation to establish performance characteristics; laboratories perform verification to confirm those characteristics are met in their specific environment.
CLC Professional Standards & Competencies 3
Which CLIA certificate level is required for laboratories performing tests classified as 'high complexity'?