High Complexity Laboratories

For Testing Personnel

1. Licensed MD/DO/DPM
2. Doctoral, Master’s, or Bachelor’s degree in chemical, biological, clinical or medical laboratory science, or medical technology
3. Associates degree in a laboratory science or medical laboratory technology
4. Have education or experience equivalent to an Associate’s degree AND at least 3 months of documented training in each specialty in which the individual performs high complexity testing
5. Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician) 
6. Individulas qualified as a high complexity testing personnel  and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024 and have done so continuously since December 28, 2024.   

Moderate Complexity Laboratories

1. Licensed MD/DO/DPM
2. Doctoral, Master’s, or Bachelor’s degree in chemical, biological, clinical or medical laboratory science, or medical technology
3. Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician)
4. High School graduate or equivalent AND documentation of laboratory training appropriate for the testing performed

CLIA Personnel Requirements for High & Moderate Complexity Testing Laboratories

1. Following the laboratory’s procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient results

2. Maintaining records which demonstrate that proficiency testing samples are tested in the same manner as patient specimens

3. Adhering to the laboratory’s Quality Control policies and documenting all Quality Control activities, instrument and procedural calibrations, and instrument maintenance

4. Following the laboratory’s policies, including taking and documenting corrective actions, whenever test systems are not within the laboratory’s established acceptable levels of performance

5. Being able to identify problems that may adversely affect test performance or test result reporting and correcting the problem or notifying the appropriate supervisor

6. Documenting all corrective actions taken when test systems deviate from the labor- atory’s established performance specifications

7. If required by route of qualification, performing high complexity testing only under the on-site direct supervision of a General Supervisor

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