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  • June 27, 2011 Reference No.: FDAA11012
    described at 42 CFR § 493.20, Laboratories performing tests of moderate complexity: “subpart C or subpart D, and subparts F, H, J, K, M, and Q of this part...

  • CLIA Waiver 42 U.S.C. Section 263a(d)(3)
    By Regulation42 CFR 493.15(c) for 9 generic tests (FOB, u. preg., u. dipstick, OTC glucose, spun hematocrit, ovulation, hemoglobin single analyte instrument, hemoglobin copper sulfate, and ESR)...

  • PPT – POINT-OF-CARE TESTING and the CLIA SURVEY PowerPoint...
    42 CFR 493.15(e)(1). Follow manufacturers instructions for performing the test.

  • POINT - OF - CARE TESTING and the CLIA SURVEY
    (42 CFR § 493.1281(a)) CLIA 15 PROFICIENCY TESTING • Each laboratory must enroll in a proficiency testing program that meets the criteria in subpart I. • At least twice annually...

  • The CLIA Framework
    4 42 CFR 493.15. 2 1 Proficiency Testing (PT) Programs CLIA requires laboratories to take ongoing measures to verify the accuracy of tests and procedures.

  • Recommendations: Clinical Laboratory Improvement Amendments...
    (42 CFR 493.15(e).) You should state that any modification to the test or the manufacturer’s instructions will result in the test being classified as high complexity.

  • PART 493—LABORATORY REQUIREMENTS
    493.1850 Laboratory registry. 42 CFR Ch. IV (10–1–11 Edition) requirements are the same for Medicare approval as for CLIA certification. ї 493.2 Definitions.

  • Reference: Oregon School-Based Health Centers Standards...
    (42CFR493.1251) (42CFR493.15(e)(1)(2) Lab process adheres to manufacturer guidelines. Products currently used are matched to those in procedure manual.

  • RSV Test
    42 CFR 493.15 (e) (1). 4. Dispose of swab into appropriate container. TEST PROCEDURE FOR SPECIMENS 1. Remove the test from the pouch and lay it on a flat surface.

  • Guidance for Industry and FDA Staff
    The implementing regulations are codified at 42 CFR Part 493.

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