Regulatory compliance for point-of-care testing. A perspective from the United States (Circa 2000).
Regulatory guidelines concerning point-of-care testing have had a major impact on the development and evolution of these technologies. Beginning with mandates under CLIA '88, hospital accreditation organizations have developed guidelines for the management of point-of-care testing to ensure quality testing. Over the past decade, most hospitals have learned to manage these new technologies as part of the laboratory quality assurance program. Issues concerning regulatory compliance continue to influence the development and use of point-of-care technologies providing opportunity for continuous quality improvement and improved patient care.
Lee-Lewandrowski
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Department of Pathology and Clinical Laboratories, Massachusetts General Hospital, Boston, Massachusetts, USA.
Lewandrowski
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D017408:Guidelines as Topic; D006801:Humans; D007755:Laboratories, Hospital / Q000331:legislation & jurisprudence; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence*; D019095:Point-of-Care Systems / Q000331:legislation & jurisprudence*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D014481:United States