The impact of new regulations on laboratory testing in physicians' offices

The reaction of the clinician to the specter of regulation of any part of his or her practice mirrors the reaction of the laboratorian to the implementation of Medicare and Clinical Laboratory Improvement Amendments legislation in 1965 and 1967, respectively. Whether the regulatory burdens that will be visited upon these laboratories are justified or necessary is arguable; the fact of the upcoming regulation is not. The volume and breadth of testing in physicians' office laboratories (POLs) has increased exponentially since passage of the Diagnosis Related Group legislation by Congress in 1983, an increase made possible by remarkable developments in technology. State regulatory initiatives and private accrediting agencies have been perceived as being inadequate to prevent the proliferation of poorly controlled testing in the nontraditional laboratory environment. The testing menu of a given POL varies according to the scope of clinical services offered; the size of the practice group; the funding available for equipment and personnel acquisition; and the general availability of hospital, reference, and consultative laboratory services. Physicians who offer laboratory services as part of their practices must now prepare their laboratories to meet whatever requirements are mandated by regulation. This will include acquisition of trained personnel, improvement of instrumentation and methodologies, participation in proficiency testing, establishment of comprehensive quality-assurance programs, and adequate documentation of laboratory services. Organized medicine should devote its energies to assisting with needed educational processes to assure the survival of POLs.