Point-of-Care Testing: Guidelines and Challenges

Abstract

patients. With the pressures to reduce hospital length of stay and with newer therapy options, the laboratory has been asked to decrease the turnaround time from sample to result. Therefore, point-of-care testing (POCT), testing near the patient or bedside, was developed to generate quicker results. The goal of POCT is to provide the clinician with rapid results, which can improve patient outcomes and quickly supply therapeutic interventions as compared to those results obtained from the core laboratory. Laboratory point-of-care testing is not new; however, it experienced a veritable explosion in manufacturing, clinical oversight, and regulations following the “waived provision” of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The number of laboratories holding a Certificate of Waiver increased from 67 294 in 1993 to 105 138 in 2004. In addition, the number of Medicare Part B waived tests performed increased from 14 million to over 23 million between the years 2000 and 2004. (See Table 1.) Inherent with POCT growth come challenges in performing high quality accurate testing. Decreasing laboratory errors and improving patient safety must also be considered as POCT increases. The Centers for Medicare and Medicaid Services (CMS) regulates laboratory testing on humans through CLIA to ensure quality testing. CLIA classifies tests as “waived complexity,” “moderate complexity,” and “high complexity” based upon criteria developed by the federal Department of Health and Human Services. Waived complexity tests are simple laboratory examinations that are approved for home use and which employ methodologies that are simple and accurate. They render the likelihood of erroneous results negligible or pose no risk of harm to the patient if the test is performed incorrectly. Quality standards for moderately and highly complex tests are designated for proficiency testing, patient test management, quality control, personnel qualifications, quality assurance, and quality control. The more complex the test, the more stringent the testing requirements. A complete listing of the tests by classification can be found on the website of the Center for Devices and Radiological Health of the US Food and Drug Administration. Point-of-Care Testing: Guidelines and Challenges