San Diego L J
Health Care Management Development Center, Clinton Twp., MI 48038, USA.
Clin Lab Sci. 1997 Nov-Dec;10(6):339-46.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) are still an evolving process just as they were when formally launched in September 1992. In developing and guiding CLIA '88 programs, the Health and Human Services relied on 2 key agencies; the Health Care Financing Administration, and the Centers for Disease Control and Prevention within the Public Health Service. CLIA '88 established an important key position for laboratory personnel: the consultant with technical and scientific oversight of moderate complexity test performance, who also consults with laboratory clientele regarding diagnosis, treatment, and management of patient care, including the appropriateness of test(s) ordered. With these responsibilities, it is imperative for consultants and laboratory managers to thoroughly understand regulatory issues in consulting to determine the fine line between what is legal and what is not, and to ascertain any fraudulent and abusive over-utilization of laboratory services and claims under government health care programs. Current federal regulatory policies that clinical laboratory practitioners must be aware of and comply with will be discussed in this article.
1988年的《临床实验室改进修正案》（CLIA '88）如今仍在不断发展，就如同1992年9月正式推出时一样。在制定和指导CLIA '88计划的过程中，卫生与公众服务部依赖于两个关键机构：医疗保健财务管理局以及公共卫生服务部内的疾病控制与预防中心。CLIA '88为实验室人员设立了一个重要的关键职位：对中等复杂程度检测操作进行技术和科学监督的顾问，该顾问还就患者护理的诊断、治疗和管理，包括所开检测项目的适当性等问题，与实验室客户进行沟通。鉴于这些职责，顾问和实验室管理人员必须透彻理解咨询过程中的监管问题，以确定合法与非法行为之间的界限，并查明在政府医疗保健计划下实验室服务和索赔中任何欺诈性和滥用性的过度使用情况。本文将讨论临床实验室从业者必须了解并遵守的现行联邦监管政策。
