CLIA Requirements + Responsibilities for:
High Complexity Laboratories
- Qualified Lab Director or Technical Supervisor of high complexity testing
- Licensed MD/DO/DPM, or have a Doctoral, Master’s, or Bachelor’s degree in lab science AND 1 year laboratory training or experience in high complexity testing
- Qualified as Testing Personnel for high complexity testing AND at least 2 years laboratory training or experience in high complexity testing
- Previously qualified as General Supervisor on or before 02/28/1992
- Prior to 09/01/1992, served as General Supervisor of high complexity testing AND prior to 04/24/95 completed military Medical Lab Specialist (50 week course) AND had at least 2 years lab training or experience in high complexity testing OR graduated from an HHS-approved lab training program AND had at least 2 years lab training or experience in high complexity testing
- Prior to 09/01/1992, served as General Supervisor of high complexity testing AND have a high school diploma or equivalent AND more than 10 years of experience in high complexity testing including at least 6 years supervisory experience from 09/01/1982 to 09/01/1992
- Prior to 09/01/1992, served as General Supervisor of high complexity testing and prior to 01/01/1994: passed an HHS approved technical proficiency exam given between 03/01/1986 and 12/31/1987 AND have 6 years lab training or experience with 2 years in high complexity testing specialties
- Is accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic support
- Provides day to day supervision of personnel performing high complexity testing
- Must be on-site to provide direct supervision when high complexity testing is performed by certain individuals
- Monitors test analyses and specimen examination to ensure that acceptable levels of analytic performance are maintained
- Fulfills certain responsibilities as delegated by the Lab Director and/or Technical Supervisor. These may include:
- Resolving technical problems and ensuring corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications
- Ensuring patient test results are not reported until all corrective actions have been taken and the test system is functioning properly
- Providing orientation to all testing personnel
- Evaluating and documenting the performance of all testing personnel as required
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