CLIA Requirements + Responsibilities for:
High Complexity Laboratories
1. Licensed MD/DO/DPM
2. Doctoral, Master’s, Bachelor’s or Associate’s degree in laboratory science
3. Have education or experience equivalent to an Associate’s degree AND graduated from a clinical laboratory training program OR have 3 months experience in each specialty of high complexity testing performed
4. Prior to 04/24/1995, High School graduate or equivalent AND graduated from an HHS-approved lab training program OR completed military Medical Lab Specialist (50 week) course
5. Prior to 04/24/1995, High School graduate or equivalent AND documentation of training for high complexity testing AND if training before 01/19/93, on-site supervision is required when high complexity testing is performed
Moderate Complexity Laboratories
1. Licensed MD/DO/DPM
2. Doctoral, Master’s, Bachelor’s, or Associate’s degree in laboratory science
3. High School graduate or equivalent AND completed military Medical Lab Specialist (50 week) course
4. High School graduate or equivalent AND documentation of training at the present facility for testing performed
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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