Professional Standards & Competencies Flashcards
7 cards from real CLC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Professional Standards & Competencies flashcards as text
Which CLIA certificate level is required for laboratories performing tests classified as 'high complexity'?
Answer: Certificate of Compliance
A Certificate of Compliance (or Accreditation) is required for laboratories performing high-complexity testing under CLIA regulations.
A consultant recommends a laboratory implement a delta check system. The primary purpose of this quality tool is to:
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.
Competency assessment for laboratory testing personnel must be performed:
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.
Which of the following is NOT one of the six CLIA-mandated competency assessment elements?
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.
When a laboratory introduces a new quantitative test, the minimum number of samples typically required to establish analytical measurement range (AMR) is:
Answer: 20
Clinical laboratory guidelines (e.g., CLSI EP06) recommend a minimum of approximately 20 samples spanning the reportable range to establish AMR.
A laboratory consultant reviewing critical value policies should verify that the policy addresses:
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.
The primary difference between validation and verification of a laboratory test method is that:
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.