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Research Article| Volume 13, ISSUE 3, P739-752, September 1993

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Federal Regulation of Clinical Laboratories and the Clinical Laboratory Improvement Amendments of 1988-Part I

DOI:https://doi.org/10.1016/S0272-2712(18)30438-4
Federal Regulation of Clinical Laboratories and the Clinical Laboratory Improvement Amendments of 1988-Part I
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      This is the first of two articles summarizing federal regulations applicable to clinical laboratories and emphasizing pertinent features of The Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), including the complexity model, waived testing, personnel standards, proficiency testing, quality control requirements, and patient test management. The history of laboratory regulations is reviewed and regulatory events subsequent to the CLIA 1988 Final Rule of February 1992 are described.
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      References

        • Boone D.J.
        Literature review of research related to the Clinical Laboratory Improvement Amendments of 1988.
        Arch Pathol Lab Med. 1992; 116: 681-693

      2. 29 Code of Federal Regulations Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule. Federal Register. December 6, 1991;56(No. 235):64175-64182

      3. 42 Code of Federal Regulations Part 405, et al. Federal Register. February 28, 1992;57(No. 40):7138-7243

      4. 29 Code of Federal Regulations Part 1910.1048. Federal Register. May 27, 1992;56(No. 102):22310

      5. 42 Code of Federal Regulations Part 493, et al. Technical corrections, Regulations implementing the Clinical Laboratory Improvement Amendments of 1988. Federal Register. January 19, 1993;58(No. 11):5215-5237

        • College of American Pathologists and American Society of Clinical Pathologists
        A summary of major provisions of the Final Rules implementing the Clinical Laboratory Improvement Amendments of 1988. College of American Pathologists, Northfield, IL1992

      7. Occupational exposure to hazardous chemicals in laboratories. Bureau of National Affairs, Inc. Washington DC, 1990, p 96

      8. 42 USC§263(a)

      Article info

      Identification

      DOI: https://doi.org/10.1016/S0272-2712(18)30438-4

      Copyright

      © 1993 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

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