MD, DO with current medical license in state of lab’s location AND certified in anatomic and/or clinical pathology by ABP, AOBP, or equivalent qualifications
MD, DO, DPM with current medical license in state of lab’s location AND 1-year laboratory training during medical residency
MD, DO, DPM with current medical license in state of lab’s location AND 2 years’ experience in directing/supervising high complexity testing
PhD in chemical, physical, biological or clinical laboratory science AND certification by the HHS
approved boards (effective 02/24/2003)
Hold an earned PhD in chemical, physical, biological, or clinical laboratory science from an accredited institution AND until 12/31/2002 must have served or be serving as director of a laboratory performing high complexity testing AND must have at least 2 years of laboratory training or experience or both
AND 2 years of experience directing or supervising high complexity testing. (Directors meeting
this qualification will be “grandfathered” in by CMS)
ON OR BEFORE 02/28/1992:
Serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under laboratory regulations published 03/14/1990
ON OR BEFORE 02/28/1992:
Qualified as director by the state in which the laboratory is located
The Laboratory Director is responsible for the overall operation and administration of the lab, and must ensure the competency of all laboratory personnel. Specific Lab Director responsibilities include:
Verify that all delegated duties are properly performed.
Must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. Visit the laboratory at a minimum twice a month.
May direct no more than five labs.
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.
Ensure testing systems provide quality laboratory services across the path of work-flow (for all phases of testing: pre-analytic, analytic, and post-analytic phases).
Ensure test methods selected have the capability of providing quality results.
Ensure verification procedures are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method.
Ensure that test result reports include pertinent information required for interpretation.
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.
Ensure that an approved procedure manual is available to all personnel.
Ensure that laboratory personnel are performing the test methods as required to obtain accurate and reliable results.
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.
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.
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: To process specimens, Perform test procedures, Report test results promptly and proficiently, and whenever necessary, Identify remedial training and/or continuing education needs to improve skills.
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, and 3) whether consultant or director review is required prior to reporting patient test results.
Ensure that a general supervisor provides on-site supervision of certain testing personnel who perform high complexity testing.
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.
Ensure that PT samples are tested in compliance with regulations that prohibit referral of specimens and sharing of or communication about results.
Ensure that PT results are returned on time to the PT program.
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.
Ensure that quality control and quality assessment programs are established and maintained to identify failures in quality as they occur.
Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
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.
Requirements: For PhDs:
The qualification for a laboratory director of high-complexity testing is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS. The current approved boards are the following: