Review Article| Volume 29, ISSUE 3, P463-478, September 2009

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Regulatory Compliance for Point-of-Care Testing: 2009 United States Perspective


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      1. Public Law 100–578, Section 353 Public Health Service Act (42 U.S.C. 263a) October 31, 1988.

        • US Centers for Medicare & Medicaid Services (CMS)
        Medicare, Medicaid, and CLIA Programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final rule.
        Fed Regist. 2003; 16 (Current CLIA Regulations (including all changes through 01/24/2003) Available at:) (Accessed December 11, 2008.): 3640-3714
      2. CMS state operations manual appendix C, regulations and interpretive guidelines for laboratories and laboratory services.
        (Available at:) (Accessed December 11, 2008)
      3. Laboratory accreditation standards. Joint Commission. Oakbrook Terrace (IL).
        (Available at:) (Accessed December 11, 2008)
      4. Laboratory accreditation program. College of American Pathologists (CAP).
        (Available at:) (Accessed December 11, 2008)
      5. Accreditation manual. COLA. Columbia (MD).
        (Available at:) (Accessed December 11, 2008)
      6. CLIA certificates.
        (Available at:) (Accessed December 11, 2008)
      7. CLIA certificate fee schedule.
        (Available at:) (Accessed December 11, 2008)
      8. Provider-performed microscopy procedures.
        (Available at:) (Accessed December 11, 2008)
      9. CMS 116 form.
        (Available at:) (Accessed December 11, 2008)
      10. Number of CLIA certificates.
        (Available at:) (Accessed December 11, 2008)
      11. Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices.
        (Available at:) (Accessed December 11, 2008)
      12. CLIA test method complexity classifications.
        (Available at:) (Accessed December 11, 2008)
        • Clinical and Laboratory Standards Institute 2008
        (Available at:) (Accessed December 11, 2008)
        • Ehrmeyer S.S.
        • Laessig R.H.
        Centers for Medicare and Medicaid Services' equivalent quality control and manufacturers' internal quality control systems: still confused after all these years?.
        Point of Care. 2008; 7: 76-78
        • McDowell J.
        Revisiting equivalent quality control.
        Clin Lab News. 2005; 31 (1,3,6)
      13. Continuation and revision of the components of the Clinical Laboratory Improvement Amendments (CLIA) educational period regarding certain quality control (QC) requirements.
        (Available at:) (Accessed December 11, 2008)
        • Malone B.
        Risk management for clinical labs.
        Clin Lab News. November 2008; (Available at:) (Accessed December 11, 2008)
      14. CLIA proficiency testing programs.
        (Available at:) (Accessed December 11, 2008)
        • Goldsmith B.
        • Porter E.
        Ensuring quality in a multihospital POC program: one system's approach.
        Point of Care. 2005; 4: 167-173
        • Laessig R.H.
        • Ehrmeyer S.S.
        Quality management and administration.
        in: Kost G.J. Point-of-care testing: principles, management, and clinical practice. Lippincott Williams & Wilkins, Philadelphia2002: 422-423