Health Devices. 1992 Nov;21(11):420-5.
One clinical pathologist has noted that the broad scope of CLIA means "that every testing situation in the hospital, whether in or out of the laboratory, could now be a liability for ... hospital administration." Portions of CLIA became effective September 1, 1992; thus, it is important that all appropriate personnel are aware of the requirements of CLIA and that all ancillary testing sites are accounted for. CLIA will require unprecedented coordination and cooperation between the clinical laboratory and ancillary sites. Also, clinical laboratories must comply with the sometimes more stringent state regulations and requirements of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and CAP. JCAHO, for example, has regulations specific to blood glucose monitors--regulations that demand a high level of QC, proficiency testing, and documentation. In contrast, CLIA categorizes blood glucose monitoring as a waived test. (This classification has been widely criticized by laboratory organizations, which argue that an erroneous result from a blood glucose monitor could be deadly for the patient.
一位临床病理学家指出，《临床实验室改进修正案》（CLIA）涵盖范围广泛，这意味着“医院内的每一种检测情况，无论是否在实验室进行，现在都可能成为……医院管理部门的责任”。CLIA的部分条款于1992年9月1日生效；因此，重要的是所有相关人员都要了解CLIA的要求，并且要对所有辅助检测地点进行统计。CLIA将要求临床实验室与辅助检测地点之间进行前所未有的协调与合作。此外，临床实验室必须遵守有时更为严格的州法规以及医疗保健组织认证联合委员会（JCAHO）和美国病理学家协会（CAP）的要求。例如，JCAHO针对血糖仪有特定的规定——这些规定要求高水平的质量控制、能力验证测试和文件记录。相比之下，CLIA将血糖监测归类为简易检测项目。（这种分类受到了实验室组织的广泛批评，他们认为血糖仪得出的错误结果可能对患者致命。
