Laboratory procedure manual for clia waived tests

PROCEDURE MANUAL _____ Product Code: DTG- Mono Rev Page 2 of 14 Lab Name: CLIA Complexity: WAIVED INTENDED USE The Clarity Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma) is an immunochemical device intended for . Waived tests include test systems cleared by the Food and Drug Administration (FDA) for home use and those tests approved for waiver under the Clinical Laboratory Improvement Amendments of (CLIA) criteria. The FDA list of waived tests is continuously being revised as new tests are waived. The. the testing that can be performed in each category, and the applicable standards that must be met to comply with CLIA ’ The fifth chapter, “The Proficiency Testing Requirements Under CLIA ’88,” describes proficiency testing (PT) and the standards that physicians owning non-waived laboratories must meet to comply with the CLIA PT.

This CLIA Compliance Manual contains policies and procedures to help you comply with the final Clinical Laboratory Improvement Amendments, which became effective on Ap. We hope this manual becomes a valuable tool for you and your laboratory staff. Before using the VIDAS®. The laboratory safety manual provides a concise reference for orientation of new personnel to the laboratory and a source of information to answer questions in the absence of the regular laboratory staff. This reference should be developed and maintained by the health services (HS) technician assigned to the laboratory. DISCUSSION: Enclosure (1. documenting the training and competency of the testing staff of the ACHDLS. All laboratory testing, under CLIA, is categorized as waived or nonwaived. a. Waived tests performed by the county health department laboratories: Hemoglobins by HemoCue Method, Occult Bloods by InSure FIT, HCG by Pregnancy Test, Strep A Rapid Test, and Urine Dipstick.

Jan As stated previously, a CLIA waiver can be granted for, among others, tests that are “simple laboratory examinations and procedures that have an. Dec Centers for Medicare and Medicaid Services CMS recently released QSOCLIA: Revisions to State Operations Manual SOM Chapter 6. Policy: CLIA Complexity: Waived. Method: Hemoccult Fecal Occult Blood Test with the laboratory's Proficiency testing for additional quality assurance.