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During the retention period, specimens are considered to be part of the medical record and must be kept under a CLIA accredited laboratory to ensure compliant handling and storage conditions. [ 25 ] [ 26 ] If a specimen is sent-out to a non-CLIA biorepository and recalled, the additional testing would not be in compliance. [ 25 ]
Tests that are already cleared or approved for home use or are waived by 42 CRF 293.15(c), are classified as waived. [ 36 ] [ 37 ] Otherwise, the tests are either classified as moderate or high complexity based on seven categorization criteria listed in 42 CFR 493.17. [ 38 ]
CFR Title 42 - Public Health is one of fifty titles comprising the United States Code of Federal Regulations (CFR). Title 42 is the principal set of rules and regulations issued by federal agencies of the United States regarding public health, including respirator rules and regulations moved from CFR Title 30 (including MSHA), to the Public Health Service (including NIOSH and the CDC).
This file is a work of the Centers for Disease Control and Prevention, part of the United States Department of Health and Human Services, taken or made as part of an employee's official duties. As a work of the U.S. federal government , the file is in the public domain .
It serves patients, pathologists, and the public [1] by fostering and advocating best practices in pathology and laboratory medicine. [ 2 ] It is the world's largest association composed exclusively of pathologists certified by the American Board of Pathology, [ 3 ] and is widely considered the leader in laboratory quality assurance.
This image is a work of the United States Department of Health and Human Services, taken or made as part of that person's official duties. As a work of the U.S. federal government , the image is in the public domain .
This image is a work of the United States Department of Health and Human Services, taken or made as part of that person's official duties. As a work of the U.S. federal government , the image is in the public domain .
Download as PDF; Printable version; In other projects Wikidata item; Appearance. move to sidebar hide. CLIA may refer to: Chemiluminescent immunoassay ...