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Sharon S. Ehrmeyer, Ronald H. Laessig
Point-of-care testing, medical error, and patient safety: a 2007 assessment
Keywords: Clinical Laboratory Improvement Amendments (CLIA) regulation, clinical laboratory testing, errors, patient safety, point-of-care testing, quality
Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. “Errors” in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre-analytical, analytical and post-analytical) can be virtually eliminated by proper design of testing systems. We cite examples of two systems that have made exceptional progress in this respect. It has been recently suggested that the basic errors associated with the testing process are amplified in the POC setting. Two of the amplifiers – incoherent regulations and failure of clinician/caregivers to respond appropriately to POCT results – lead us to recognize additional changes in today's POCT environment. The first is a willingness of manufacturers, not laboratories, to take responsibility for the quality of test results – an outgrowth of an industrial philosophy called autonomation. The second is a need to substantially modify the clinician/caregiver test utilization paradigm to take full advantage of POCT results, available on site in real time. Both have already begun to take place.
Clin Chem Lab Med 2007;45:766–73.
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 45, 06/2007
Pages: 766 - 773