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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 ]
English: Contains a compilation of Presidential documents and a codification of 42 CFR regulations issued by the Executive Office of the President for the year 2003. Date 1 October 2003
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).
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 ]
Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9] The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests.
For example, 42 C.F.R. § 260.11(a)(1) would indicate "title 42, part 260, section 11, paragraph (a)(1)." Conversationally, it would be read as "forty-two C F R two-sixty point eleven a one" or similar. While new regulations are continually becoming effective, the printed volumes of the CFR are issued once each calendar year, on this schedule:
It is available in digital and printed form, and can be referenced online using the Electronic Code of Federal Regulations (e-CFR). 30 CFR Part 11 regulations for respirators have been moved to Title 42, Part 84. [1]
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