High Complexity Laboratories

1. Licensed MD/DO/DPM AND certified in anatomic or clinical pathology OR 2 years experience directing or supervising high complexity testing AND 20 CE credit hours in laboratory practice that cover the director responsibilities
2. Doctoral degree in a chemical, biological, or laboratory science AND certified by an HHS-approved board AND 2 years experience directing AND 2 years supervising high complexity testing AND 20 CE credit hours in laboratory practice that cover the director responsibilities
3. Individuals qualified as a high complexity laboratory director and serving as a high complexity testing laboraotry director in a CLIA-certified laboratory as of December 28, 2024 and have done so continuously since December 28, 2024.
4. For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology.

Moderate Complexity Laboratories

1. Licensed MD/DO/DPM, AND certified in anatomic or clinical pathology, OR lab training or experience consisting of 1 year directing or supervising non-waived tests and 20 CME credits in lab practice that cover the lab director responsibilities
2. Doctoral degree in a chemical, biological, or laboratory science AND certified by an HHS-approved Board, AND have 1 year experience directing or supervising non-waived testing, AND 20 CME credits in lab practice cover the lab director responsibilities
3. Master’s degree in a chemical, biological, or laboratory science AND 1 year lab training or experience AND 1 year of experience supervising non-waived testing AND 20 CME credits in lab practice that cover the lab director responsibilities
4. Bachelor’s degree in a chemical, biological, or laboratory science AND 2 years lab training or experience AND 2 years experience supervising non-waived testing, AND 20 CE credit hours in laboratory practice that cover the director responsibilities
5. Individuals qualified as a moderate complexity laboratory director and serving as a moderate complexity testing laboraotry director in a CLIA-certified laboratory as of December 28, 2024 and have done so continuously since December 28, 2024.

Requirements

1. Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to verify that they maintain competency
2. Ensure that all personnel have the appropriate education and experience prior to testing patient specimens; receive appropriate training for the type and complexity of services offered; and have demonstrated that they can perform all testing operations reliably to provide and report accurate results
3. Employ a sufficient number of laboratory personnel with appropriate education, experience and/or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results
4. Ensure that laboratory personnel are performing the test methods as required to obtain accurate and reliable results
5. Ensure that an approved procedure manual is available to all personnel
6. Ensure that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions
7. Ensure that test result reports include pertinent information required for interpretation
8. Ensure verification procedures are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method
9. Ensure test methods selected have the capability of providing quality results
10. Ensure testing systems provide quality laboratory services across the path of workflow (for all phases of testing: pre-analytic, analytic, and post-analytic phases)
11. Ensure that the physical plant and environmental conditions are appropriate for the testing performed and provide a safe environment, free of physical, chemical, and biological hazards
12. May direct no more than five labs
13. Must be accessible to the laboratory to provide onsite, telephone, or electronic con- sultation as needed
14. Verify that all delegated duties are properly performed
    1. To process specimens
    2. Perform test procedures
    3. Report test results promptly and proficiently
    4. Whenever necessary, identify remedial training and/or continuing education needs to improve skills
15. Have a written list of responsibilities of each individual in the laboratory that specifies:
    1. The level of activity each is authorized to perform,
    2. Whether supervision is required for specimen processing, test performance or results reporting
    3. Whether consultant or director review is required prior to reporting patient test results
16. Ensure that a general supervisor provides on-site supervision of certain testing personnel who perform high complexity testing
17. Ensure that the laboratory is enrolled in an approved proficiency testing (PT) program Ensure that PT samples are tested in the same manner as patient samples
18. Ensure that PT samples are tested in the same manner as patient samples
19. Ensure that PT samples are tested in compliance with regulations that prohibit referral of specimens and sharing of or communication about results
20. Ensure that PT results are returned on time to the PT program
21. Ensure that PT results are reviewed by the appropriate staff, and the corrective action plan is followed when PT results are found to be unsatisfactory
22. Ensure that quality control and quality assessment programs are established and maintained to identify failures in quality as they occur
23. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system
24. Ensure that corrective actions are taken and documented, whenever significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly

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