High Complexity Laboratories

1. Qualified Lab Director or Technical Supervisor of high complexity testing
2. Licensed MD/DO/DPM OR have a Doctoral, Masters, or Bachelor’s degree in a chemical, biological, clinical or medical laboratory science, or medical technology AND have at least 1 year of laboratory training or experience or both in high complexity testing
3. Qualify as testing personnel AND have at least 2 years of laboratory training or experience, or both in high complexity testing
4. Individulas qualified as a high complexity general supervisor and serving as a high complexity testing general supervisor in a CLIA-certified laboratory as of December 28, 2024 and have done so continuously since December 28, 2024.

Requirements

1. Is accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic support

2. Provides day to day supervision of personnel performing high complexity testing

3. Must be on-site to provide direct supervision when high complexity testing is performed by certain individuals

4. Monitors test analyses and specimen examination to ensure that acceptable levels of analytic performance are maintained

5. Fulfills certain responsibilities as delegated by the Lab Director and/or Technical Supervisor. These may include:
   1. Resolving technical problems and ensuring corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications
   2. Ensuring patient test results are not reported until all corrective actions have been taken and the test system is functioning properly
   3. Providing orientation to all testing personnel
   4. Evaluating and documenting the performance of all testing personnel as required

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