By: Dean Viskovich
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations. The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.
The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA. CLIA prohibits a laboratory director from directing more than five non-waived laboratories. Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position. The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position.
A laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of competent qualified personnel. A laboratory director can delegate some of his responsibilities but is ultimately responsible and must make sure that all the duties are correctly performed and that the CLIA regulations are met. The lab director is responsible to make sure the laboratory develops and implements a quality system approach to lab testing that provides accurate and reliable patient test results.
A lab director is not automatically qualified to oversee the lab just because the director meets the experience and education requirements set by CLIA. The director must demonstrate the ability to provide effective direction over lab operations. A laboratory director has the responsibility that testing systems in the lab provide quality services in all areas of test performance, including pre-analytic, analytic, and post-analytic phases of testing and are appropriate for the patient population. The director must ensure that the environmental and physical conditions of the laboratory are adequate and appropriate for the tests performed and the environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed. Additional responsibilities include, confirming a general supervisor (high complexity testing) is available to provide day-to -day supervision of all testing personnel and the report of test results. The director should provide on-site supervision for qualified testing personnel when performing high complexity testing and confirm trained personnel accurately perform tests and report result tests. The lab director must supervise new test procedures and is required to review employee responsibilities and confirm that duties are specified in writing.
The lab director responsibilities are codified by the federal government at 42CFR section 493.1445 (Standard; Laboratory director responsibilities). The regulation states “The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.” Compliance with federal and state rules and regulations regarding the lab director is a requirement and ongoing process that stakeholders must continually monitor.
The lab director is the most important role in the clinical lab space and important consideration must be undertaken in fulfilling this position prior to undertaking ownership in a CLIA accredited lab.