Moderate complex clia laboratory
[DOCX File]CCR Template - Colorado
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Clinical Laboratory Improvement Amendments (CLIA) ... (QSART) is a diagnostic test used to diagnose Complex Regional Pain Syndrome. This test is performed on a minimum of two (2) extremities and encompasses the following components: ... Moderate (Conscious) Sedation.
[DOC File]Microsoft Word - Health Services, Medical Assisting AMT ...
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Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) Understand and comply with quality assurance regulations for . Training. ... Know training requirements for moderate and complex laboratory procedures. Recognize normal and abnormal values of common laboratory results.
[DOC File]LOURDES HOSPITAL
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1. The OSOM Strep a Test has been categorized as CLIA waived only for the application of qualitative detection of Group A Streptococcal Antigen from throat swabs. 2. The results obtained with this kit yield data that must be used only as an adjunct to other information available to the physician.
[DOC File]GAP Appendix - Partners HealthCare
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CLIA (Clinical Laboratory Improvement Amendments): A set of regulations, administered through the federal Health Care Financing Administration (HCFA), which sets minimum requirements for any laboratory that conducts tests (including genetic tests) communicated to a patient, physician, or any other health care provider. ... Complex Inheritance ...
[DOC File]105 CMR: DEPARTMENT OF PUBLIC HEALTH
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Moderate-Complexity Testing means tests categorized as moderate complexity under CLIA. Owner means any individual, partnership, group, firm, corporation, or other entity holding either partial or complete ownership of or title to a laboratory.
[DOC File]Procedure: CLIA – waived for urine samples; Moderately ...
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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 specimens taken directly from symptomatic patients.
Florida Administrative Rules, Law, Code, Register - FAC ...
Hospitals may operate more than one CLIA certified laboratory. Each hospital laboratory shall have a qualified laboratory director. ... Testing at alternate-sites shall not exceed test categorization of moderate complexity moderately complex test procedures as described in Title 42 CFR Part 493.17 and administered by the Centers for Medicare ...
Guidance for Clinical Laboratory Improvement Amendments of ...
Laboratory Professional A person who meets the qualifications to perform moderate or high complexity testing, such as a medical technologist (MT) or medical laboratory technician (MLT). Limits of erroneous results (LER) In this guidance the limits of erroneous results are limits for the differences between the WM (waiver method) and the CM ...
[DOC File]Cepheid, Inc - Zacks Investment Research
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Xpert MTB/RIF Test: On Aug 28, 2013, the U.S. FDA categorized Cepheid's Xpert MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). The test is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.
[DOC File]INTENDED USE - Urine drug test - drug test in bulk ...
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*The Letter of Authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests” as “authorized laboratories”.
[DOC File]IN.gov | The Official Website of the State of Indiana
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Certificate of Waiver: Director change can be made with either a CMS 116 or a letter.Letter must include: Name of laboratory, CLIA number, name of laboratory director and/or owner, the change(s) being made, effective date, and the signature of the laboratory director or his/her designee.
[DOC File]External Proficiency Testing - Michigan
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The CLIA'88 legislation requires each moderately complexity and high complexity laboratory must participate in an external proficiency testing (PT) program (CFR: Subpart H:493.801) that is approved by the US HHS. Each test in the moderate or high complexity category must be tested.
[DOCX File]CIS 110 - Intro to Computer Logic and Programming
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A1.1.6Explain the purpose of the Clinical Laboratory Improvement Amendments (CLIA) 1988. ... moderate lab, and high complexity. ... Objectives vary from simple attention to selected phenomena to complex but internally consistent qualities of character and conscience.
[DOC File]Appendix A – Description of the CVD panels
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The deCODE MI™ test is offered by deCODE genetics (Reykjavik, Iceland) as a LDT on blood and buccal samples in a single CLIA-certified laboratory as a risk factor for myocardial infarction (MI). According to the deCODE website (www.decode.com), ordering the test requires submission of an informed consent form completed by the patient and ...
[DOC File]Management Statement - Michigan
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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.
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