Final CLIA regulations. Clinical Laboratory Improvement Amendments

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.