Moderate Complexity Laboratories

1. MD, DO, or DPM with a current medical license AND certified in anatomic or clinical pathology OR have at least 1 year of training and/or experience in nonwaived testing in the designated specialty/subspecialty area
2. Doctoral or Masters degree in a chemical, biological or clinical laboratory science with at least 1 year of training or experience in nonwaived testing in the designated specialty/subspecialty area
3. Bachelor’s degree in a chemical, biological or clinical or medical laboratory science with at least 2 years of laboratory training or experience in nonwaived testing in the designated specialty/subspecialty area
4. Associates degree in medical laboratory technology, medical laboratory science, or clinical laboratory science AND have at least 4 years of laboratory training or experience in nonwaived testing in the designated specialty/subspecialty.

Requirements

1. Must be available to provide needed consultation either on-site, by telephone, or electronically
2. Selects test methodology appropriate for the clinical use of the test menu
3. Verifies procedures for testing performed and establishes the laboratory’s performance criteria, including accuracy and precision of each test and test system
4. Enrolls the laboratory in an approved PT program commensurate with services offered
5. Establishes a quality control program appropriate for the testing performed, establishes the acceptable levels of analytic performance, and ensures these levels are maintained throughout the testing process
6. Resolves technical problems and ensures corrective actions are taken whenever test systems deviate from  the laboratory’s established performance specifications
7. Ensures patient test results are not reported until all corrective action has been taken and the test system is functioning properly
8. Identifies training needs and ensures testing personnel receive regular in-service training
9. Evaluates the competency of all testing personnel on an ongoing basis
10. Evaluates and documents Testing Personnel’s performance at six months and twelve months during the first year of employment and yearly thereafter. Performance is reevaluated (prior to reporting patient test results) if test methodology or instrumentation changes. The evaluation must include the use of the new test methodology or instrumentation