Clia compliance manual

Laboratory Compliance Manual Do Not Remove From Laboratory. INDEX CLIA Quality Control Program page 2 Maintenance Record-Microscope page 6 Cryostat Protocol page 7 Maintenance Record-Cryostat page 8 Media or Stain Log page 9 Refrigerator Protocol page 10 Maintenance Record-Refrigerator page 11 File Size: KB.  · Refer to the Related Links Outside CMS section below for the following information concerning the Clinical Laboratory Improvement Amendments (CLIA) regulations: The most current version of the CLIA regulations Part , including all changes through 5/12/ This information is on the Centers for. Search a database of documents related to CLIA from these sources: Code of Federal Regulations (CFR): The Code of Federal Regulations external icon is a codification (arrangement) of the general and permanent final rules published in the Federal Register by the executive departments and agencies of the Federal Government.

Clinical laboratory test systems are assigned a moderate or high complexity category on the basis of seven criteria given in the CLIA regulations. For commercially available FDA-cleared or approved tests, FDA scores the tests using these criteria during the pre-market approval process. The final score determines whether the test system is. Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. Refer to the related links section for the State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (somap_c_lab). 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.

A written procedure manual containing procedures for all activities of the CLIA'88 regulations require that all laboratory records be retained for at. Quality America, Inc. helps physician practices to comply with federal regulations such as OSHA and CLIA by providing OSHA compliance manuals, OSHA training. To subscribe, email one of the CLIA Compliance professionals listed above. In , Congress passed the Clinical Laboratory Improvement Amendments (CLIA).