Clia moderately complex tests
[DOC File]i-STAT testing
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Mar 26, 2020 · It is preferable that the test be CLIA-waivable for use by minimally trained users in decentralized testing settings, or CLIA moderately complex for use by laboratorians in small laboratories. Price targets for a robust test could be up to $30 USD.
[DOC File]English - Helena Laboratories
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(k) Provider-performed microscopy tests limited to the CLIA category of Provider-Performed Microscopy tests found in 42 CFR 493.19(c)(1-9). (19) Licensure Certificate of Exemption or Certificate of Exemption – evidence of current licensure issued to a laboratory upon application and qualification as stipulated in Section 483.106, F.S., when ...
[DOC File]Quality Assurance Guidelines for Testing Using
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The i-STAT system is approved for use as the Point of Care test at Kaleida Health for the analytes listed below. This test system is classified as a CLIA non- waived (moderately complex) test when used according to the manufacturer’s instructions.
CLIA Test Complexities | CDC
CLIA Complexity: MODERATE. INTENDED USE. The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash …
[DOC File]POINT-OF-CARE TESTING
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Since the ACT is categorized as moderately complex, ACT users must (1) perform two levels of quality control during each shift in which the test system is used clinically, and (2) subscribe to a Proficiency Testing program. Additionally, CLIA (42 CFR 493) requires that biological controls be used weekly to verify system function.
[DOCX File]Transforming medical discovery & innovation into viable ...
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The system is classified as waived or moderately complex under CLIA-88. ... Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3702 [42CFR493.2]. ... Rather, it includes (but may not be limited to) both “waived” tests under CLIA-88 and PPM, but only when either is performed by a licensed physician. ...
[DOC File]Quality Control, An Overview
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The Clinical Laboratory Improvement Amendments (CLIA) classifies laboratory tests as either waived or non-waived. Non-waived tests are further divided as either moderately complex or highly complex. Most tests performed with the Regional Laboratory System are classified as waived.
[DOC File]Procedure: CLIA – waived for urine samples; Moderately ...
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CLIA'88 recognizes, at present, three categories of testing; waived tests, moderately complex and complex testing. The Regional Laboratory System falls in the moderately complex category, even though many of its tests would fall in the waived category.
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