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M L Kenney

Publications and source records attributed to M L Kenney.

4 recordsLinked to original sources
PubMed1987

Quality assurance in changing times: proposals for reform and research in the clinical laboratory field.

The U.S. Department of Health and Human Services recently commissioned a comprehensive analysis of the effectiveness and appropriateness of federal clinical regulations. The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and clinical laboratory regulations should be based upon objective data to the maximum extent possible.

Costs and Cost Analysis↗
PubMed1987

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.

Accreditation↗
PubMed1987

Laboratory performance and regulatory requirements.

We compared performance levels of four clinical laboratory groups defined by federal regulatory characteristics, to assess the appropriateness of selected regulations: laboratories in JCAH-accredited hospitals; non-doctoral-directed independent laboratories; state-regulated but federally exempt group-practice laboratories; and unregulated laboratories in physicians' offices (POLs). Federal regulations evaluated were those dealing with the doctoral directorship requirement and exemption of POLs from regulation. Quantitative analytes were compared by using linear regression on log-normal transformations of mean absolute-z scores of proficiency test results. The scope of services offered by laboratories was statistically related to performance in quantitative analytes. Confounding effects of scope-of-service levels were statistically controlled. Proportions of errors in qualitative analytes were compared. No pattern of statistically discernible differences in performance was found between hospital laboratories and non-doctoral-directed laboratories. Both regulated non-doctoral-directed laboratories and state-regulated but federally exempt group-practice laboratories demonstrated higher levels of performance than unregulated POLs.

Hospitals↗