![]() In addition, physicians and mid-level providers have insufficient knowledge about the limits of POC tests, which can lead to poor patient care. Audits of POC sites with CLIA waivers identified serious issues with quality of testing 13 that include inadequate training, inability to locate procedure protocols, and failure to routinely follow manufacturers’ instructions. Deviation from protocols and regent expiration can result in errors that put patients at risk. POC tests are only valid within the manufacturers’ protocols and reference ranges, outlined in the package insert. The major difference between POC testing sites and CLIA-certified clinical laboratories is the rigor of the quality control measures and level of federal regulation that ensures the highest quality of clinical laboratory testing. 11 With the increasing importance of patient satisfaction metrics, the availability of POC testing has improved patient satisfaction. 8 In addition, POC tests have improved the ability of patients and physicians to directly monitor chronic conditions such as diabetes 9, 10 and improved clinic workflow by decreasing the number of follow-up calls for laboratory results. 5-7 A retrospective study in pediatric patients found that children with early diagnosis of influenza in the emergency department had shorter hospital stays, an increased chance of effective antiviral prescription, and decreased overall testing. 4 POC tests for infectious disease (eg, gonorrhea, chlamydia, group A strep, influenza) provide early diagnosis and treatment in selected groups. 2, 3Įarly diagnosis and monitoring is a major benefit of POC testing. Globally, POC testing was estimated to be worth $15 billion in 2011 and represents more than a quarter of worldwide laboratory testing. As technology has rapidly advanced, the number of POC tests performed throughout the University of California, Los Angeles (UCLA) Health system has increased, necessitating a structured approach to ensure quality. Alternatively, moderately complex POC testing can be performed in certain POC settings by licensed personnel. POC tests must undergo US Food and Drug Administration (FDA) waiver approval to be used in Clinical Laboratory Improvement Amendments (CLIA)–waived settings, such as an outpatient clinic. ![]() 1 Because tests are performed in a nonlaboratory setting, the tests are designed to be as simple as possible. Point-of-care (POC) testing is defined as a pathology or laboratory test that is performed at the site of clinical interaction, on or on behalf of the treating physician, at the time of patient consultation, therefore allowing the physician to make an immediate decision regarding treatment. ![]()
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