Kenney M L
Clin Chem. 1987 May;33(5):725-38.
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.
自1971年以来，联邦实验室法规要求获批实验室的主任须拥有博士学位。私立认证机构和一些州也要求经认证实验室的主任拥有博士学位。尚无实证研究表明主任拥有博士学位对于确保实验室质量是必要的。医生办公室实验室（POLs）不受联邦法规约束，但基于医生的医学学位获得联邦报销。尚无实证研究表明不受监管的实验室与受监管的实验室表现相当。本调查发现，在使用1983年能力验证测试数据对加利福尼亚州由博士担任主任和非博士担任主任的医疗保险认证独立实验室的表现进行统计学比较时，未发现质量上有统计学上可辨别的差异。当对受监管的非博士担任主任的全方位服务实验室与不受监管的有限服务POLs进行统计学比较时，受监管的非博士担任主任的实验室始终表现出优于POLs的性能。显然，主任拥有博士学位既不是确保实验室表现的必要条件，也不是充分条件。政府监管似乎在临床实验室领域提供了实质性的质量保证。
