Blood Gluc, Rapid Strep, Urine hCG, POC HIV, i-STAT, POC HCV, Sca-bies. While some point-of-care tests are approved for a CLIA waiver, advances in technology that enhance the rapidity of testing enable more complex, nonwaived testing to be performed at or near the site of patient care. Quality control records and Individualized Quality Control Plan (IQCP) - 2 years. and assay and developing an individualized quality control plan (IQCP). “Point-of-care testing” is a phrase used to describe the location where testing is performed, such as at the bedside or near the site of patient care. CRE, GLU, K+, Na+, tCO2, CRP i-STAT Systemf CHEM 8+ cartridge Yesi Na+, K+.Default is regulation - 493. This could apply to waived, moderate, or high complexity test systems. IQCP applies to CMS-certified, nonwaived laboratories. “ FDA-cleared external icon ” means a test system has been reviewed by the FDA and has been determined to be substantially equivalent to a test system already legally marketed for the same use.Might look like something else based on your risk assessment and director approval. For us, that looks like new lot/shipment liquid QC and that is all. “CLIA-exempt” formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program has been approved by CMS (42 CFR 493.2). Therefore (based on the algorithm you provided) you would make an IQCP based off your initial risk assessment, to include liquid vs.We have multiple hospitals, and a very large POC program, and. It resulted in doing more than 70 risk assessments for 20 IQCPs within our integrated POC program, Wyer says. These terms do not relate directly to the test complexity categories, and it cannot be assumed that a test system is waived simply because it is performed at the point of care. Sentara’s clinical specialist for POC testing Shirley Church led a team of point-of-care coordinators through each of the test systems that qualified for an IQCP. Several terms including “CLIA-exempt,” “FDA-cleared,” and “point-of-care testing” might mistakenly be confused with CLIA-waived testing.
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