Along with stipulating qualifications, the CLIA regulations specify the expected of duties for the laboratory director. The director has the responsibility for the overall administration and operation of the laboratory, including hiring personnel who are competent to perform laboratory testing and record/report test results promptly, accurately and proficiently.
In addition, the director is considered responsible for assuring compliance with the regulations. The regulations related to the director are contained in Subpart M, along with those for the technical consultant, clinical consultant and testing personnel. The laboratory director must be accessible to the laboratory to provide on-site, telephone or electronic consultation as needed.
A person may direct no more than five laboratories. The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant and testing personnel, or delegate these responsibilities to personnel meeting the appropriate qualifications, respectively; if the laboratory director reassigns performance of his or her responsibilities, he remains responsible for ensuring that all duties are properly performed. Duties for directing a moderate level laboratory include:
Physician Office Laboratory Director Duties
- Ensure that systems used for testing provide quality laboratory services for all phases of testing (including preanalytic, analytic and postanalytic).
- Ensure that the laboratory facilities (physical setting and environmental conditions) are suitable for the tests being performed and provide a safe work area in which employees are protected from physical, chemical and biologic hazards.
- Ensure that the laboratory’s test systems have the capability of providing the quality results necessary for patient care.
- Ensure that verification procedures used are adequate to determine the accuracy, precision and other applicable performance characteristics of the method.
- Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.
- Ensure that the laboratory is enrolled in an HHS approved proficiency testing program and ensure that:
- Samples are tested as required in Subpart H.
- The results are submitted within the timeframe determined by the PT provider.
- All reports are reviewed by the appropriate staff to evaluate the laboratory’s performance and identify problems that require corrective action
- An approved corrective action plan is completed when PT results are unacceptable or unsatisfactory.
- Ensure that the quality control and quality assurance programs are developed and maintained to assure quality testing and to identify failures in quality as they occur.
- Ensure that acceptable standards of testing performance are established and maintained
- Ensure that corrective actions are taken and documented whenever deviations from performance standards are identified and that patient test results are reported only when the testing is functioning properly.
- Ensure that test result reports include pertinent information required for interpretation (i.e., reference ranges, panic values, etc.)
- Ensure that consultation is available to clients (i.e., other physicians in the practice) in the area of quality of the test results reported and interpretation concerning patient conditions.
- Employ a sufficient staff with the required education/experience/training to provide consultation, supervision and test performance/reporting in accordance with the regulations.
- Ensure, prior to testing, that all staff have the required education and experience and have received the appropriate training for the testing being performed. The staff must be able to demonstrate that they can perform the testing and reliably report accurate results.
- Ensure that policies and procedures have been established for monitoring staff who perform preanalytic, analytic and postanalytic steps to assure that they are competent to process, test and report results of test procedures. When necessary, identify needs for additional training and/or continuing education in order to improve skills.
- Ensure that an approved procedure manual is available to all office personnel who are responsible for any phase of testing.
- Specify (in writing) the responsibilities and duties for each person involved with any aspect of testing. Document which tests each individual is authorized to perform, whether or not supervision is required and whether a consultant or director review is required prior to reporting results.
Source: 42 CFR 493 (Subpart M, 493.1407)
