Point-of-care testing: inspection preparedness

Bennett, J.; Cervantes, C.; Pacheco, S.
March 2000
Perfusion;Mar2000, Vol. 15 Issue 2, p137
Academic Journal
Point-of-care testing (POCT) in the operating room has changed dramatically since the implementation of the Clinical Laboratory Improvement Amendments (CLIA '88), which became effective in September 1992. With the implementation of CLIA '88, the Health Care Financing Administration (HCFA) mandated that human specimen testing 'for the purpose of diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings', must be performed by a certified laboratory or testing site. To attain and maintain accreditation, the need for more stringent and comprehensive documentation has become imperative. The Joint Commission for the Accreditation of Hospitals (JCAHO), the College of American Pathologists (CAPS), HCFA, and state regulatory agencies require data such as staff credentialling, staff training/competency, procedure manuals, quality control logs, quality assurance/corrective action plans, correlation studies, proficiency testing results, and equipment maintenance logs to assure specimens are analyzed in a reliable manner by competent personnel so as not to jeopardize the safety and well being of the patient. Developing a comprehensive, ongoing survey readiness plan that includes a pre-survey checklist of all the documentation required and having this documentation in order and up to date well in advance of the survey will greatly enhance the probability of a successful survey conducted by the various regulatory agencies.


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