Laboratory performance and director qualifications.

Since 1971, federal laboratory regulations have required that directors of approved laboratories possess earned doctorates. Private accrediting agencies and some states also require doctoral directorship of accredited laboratories. No empirical studies have demonstrated that a director's earned doctorate is necessary to assure laboratory quality. Laboratories in physicians' offices (POLs) are exempt from federal regulation but receive federal reimbursement on the basis of the physicians' medical degree. No empirical studies have demonstrated that unregulated laboratories perform comparably with regulated laboratories. This investigation found no statistically discernible differences in quality when 1983 proficiency test data were used to compare statistically the performance of doctoral- and non-doctoral-directed Medicare-certified independent laboratories in California. When regulated non-doctoral-directed full-service laboratories were statistically compared with unregulated limited service POLs, regulated non-doctoral-directed laboratories consistently demonstrated superior per formance to POLs. Evidently a director's earned doctorate is neither a necessary nor a sufficient condition to assure laboratory performance. Government regulation appears to provide substantial quality assurance in the clinical laboratory field.