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Interpretive Guidelines for Laboratories - cms
You are here: Home > Regulations and Guidance > Clinical Laboratory Improvement Amendments (CLIA) > Interpretive Guidelines for Laboratories. Refer to the related links section for the State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (som107ap_c_lab).[PDF]
State Operations Manual - cms
Survey protocols and interpretive guidelines are established pursuant to pertinent sections of the Social Security Act, the Public Health Service Act, the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and the CLIA regulations at 42 CFR Part 493 to provide guidance to personnel conducting surveys of laboratories.
About CLIA | CDC
The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS. It is also a source of guidance to laboratories for interpreting the CLIA regulations.
Part VIII: The Interpretive Guidelines - Westgard
OrganizationFormat and ContentIssues and AnswersDo’s and Don’tsReferencesAppendix C includes 7 sections that are available as Portable Document Files (PDF) that can be downloaded to your computer or printed directly. The PDF format requires that you have the Adobe Acrobat Reader installed on your computer (which is available free and can be downloaded from the Adobe website wwwe/products/acrobat/readstep2.) 1. Policy for conducting surveys (18 pages) 2. Index and Subparts A-H. General Provisions, Certificates and Proficiency Testing: §493See more on westgardUnlike the previous Appendix C that was organized in table format, the new version follows the format:Deficiency “D-tag number” CLIA standard Interpretive Guidelines, and ProbesHere’s an example for §493(a) Standard: Procedure Manual.“D5401§493 Standard: Procedure Manual(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboSee more on westgardHow should you use these Guidelines if inspected by CMS?If your laboratory is inspected for CLIA compliance, be very familiar with the Guidelines and use them as a companion document to the Final Rule. 1. The Interpretive Guidelines section will further clarify the intent of the standard and, perhaps, provide assistance on what documentation or what strategies should be included to meet the standard. With the procedure manual standard, the Guidelines state that procedures may be organized in..See more on westgard1. DO obtain a copy of Appendix C for your laboratory. You can decide whether to store that copy on your computer or to print a copy. One advantage of a printed copy is that its sheer size makes it evident there is a lot of direction being given to inspectors and it should also be obvious that the laboratory needs to pay attention to these materials. At a minimum, print the two sections on the Quality System for Nonwaived Testing, since these materials contain new information not available e..See more on westgard1. Appendix C of SOM, Regulations and Interpretive Guidelines for Laboratories and Laboratory Services, http://www/CLIA/downloads/apcindex 2. CLIA Final Rule (2002 codification of all previous rules (1992-2002). and CLIA Final Rule (January 24, 2003) http://wwwo/clia/pdf/CMS-2226-F 3. Listing of government-approved accrediting organizations. http://www/clia/downloads/ao 4. CAP Laboratory Accreditation ChecSee more on westgard
CLIA Surveyor Basic Training - Course Menu
The prerequisites for this course are completion of the CLIA Orientation Manual, a working knowledge of the Public Health Service Act, specifically Section 353, Subpart 2 Clinical Laboratories, 42 CFR part 493, the CLIA Regulations, the State Operations Manual (SOM), and SOM Appendix C.
CLIA Clinical Labs - dhhs
Nebraska fully participates in the Federal CLIA program and any laboratory or lab personnel operating in the State of Nebraska or testing samples from the State of Nebraska must follow the federal CLIA regulations.[PDF]
State Operations Manual - Indiana
(excluding CLIA), and describe the process surveyors use in making a determination of Immediate Jeopardy. The Guidelines provide a detailed analysis of the steps surveyors should follow to assist them in accurately identifying those circumstances which constitute Immediate Jeopardy: preparation, investigation, decision-making and implementation.[PDF]
CLIA Compliance Manual - biomerieux-usa
CLIA Compliance Manual contain links to websites referred to in the material. Most links will connect with the referenced site correctly, but due to settings of individual websites, some may not. The document called CLIA Contact List is correct but will not link due to
The new CLIA quality control regulations and blood gas testing
On January 12, 2004, the Centers for Medicare and Medicaid Services (CMS) published Appendix C of the State Operations Manual, a companion document to the Final Rule, which describes three “equivalent quality control” (EQC) options for laboratories to follow in lieu of adhering to the basic QC requirements described in the Final Rule.
Clinical Laboratory (CLIA) Licensing and Certification Program
Program Overview. A laboratory under CLIA is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. The Centers for Medicare & Medicaid Services..
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