According to 42 CFR 493.17, the standards for the degree of sophistication categorization are:
- Coaching and expertise knowledge
- Interpretation and decision
- Qualities of measures of performance
- Reagents and substance preparation
- Evaluation system troubleshooting and gear upkeep and
- Quality management, calibration, competence of analyzing substances
It’s CLIA waived drug test purpose to be certain that all lab test results are accurate, dependable and applicable regardless of where the evaluation was conducted.
The CLIA of 1988 national regulatory criterions don’t apply to fundamental research testing and clinical trials.
Every lab system evaluation and assay is categorized because of its degree of sophistication. A score of two is awarded for the test that drops between the features listed for 1st and 3rd levels of sophistication.
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