Moderate Complexity Laboratories

1. Licensed MD/DO/DPM AND certified in anatomic or clinical pathology OR 1-year lab training or experience in non-waived specialty/subspecialty of service
2. Doctoral or Master’s in laboratory science AND 1-year lab training or experience in non-waived specialty/subspecialty of service
3. Bachelor’s degree in laboratory science AND 2 years lab training or experience in non-waived specialty/subspecialty of service

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