Elsewhere On The Web
The Joint Commission Laboratory Accreditation Program
The Joint Commission also has a link to "Quality Check," a comprehensive guide to all Joint Commission-accredited healthcare organizations.
The CLIA program home page at the Centers for Medicare and Medicaid Services contains a "General Program Description," "Laboratory Registry" (to check the accreditation status of a laboratory), links to inspection agencies, and more.
To see sample inspection checklists used for laboratory inspections: College of American Pathologists
To see which tests are permitted to be performed in doctor's office laboratory settings (called "waived tests" because CLIA requirements have been waived for them), visit this Food and Drug Administration site.
For more technical information, including links to "Search Federal Register" and "Code of Federal Regulations," visit the Centers for Disease Control and Prevention page.
This article was originally written by Eric Seaborg.
NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.
Sources Used in Current Review
Henry's Clinical Diagnosis and Management by Laboratory Methods. 22nd ed. McPherson R, Pincus M, eds. Philadelphia, PA: Saunders Elsevier: 2011. Pp 7-9, 73-78, 132-134.
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Burtis CA, Ashwood ER, Bruns DE, eds. 5th edition, St. Louis: Elsevier Saunders; 2012, Chp 8.
(Aug 10, 2015) Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). Available online at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ through https://www.cms.gov. Accessed September 2015.
Sources Used in Previous Reviews
Tietz Textbook of Clinical Chemistry. Edited by Carl A. Burtis & Edward R. Ashwood; W. B. Saunders: Philadelphia, 1994, Pp 75.
Clinical Chemistry: Theory, Analysis, Correlation. Third Edition, Lawrence A. Kaplan and Amadeo J. Pesce; Mosby: St. Louis, 1996, Pp 45-64: "Laboratory Management" and Pp 65-82: "Sources of Control of Preanalytical Variation."
Interview with Vince Stine, Government Affairs Program Director at the American Association for Clinical Chemistry.
Interview with Debra Nadel, Professional Affairs Manager at the American Association for Clinical Chemistry and former laboratory director.
Interview with Dr. Scott Luria, MD, board-certified internist, Associate Professor of Medicine, University of Vermont, Fellow of the American College of Physicians, Site Manager, Fletcher Allen Health Care, Division of Primary Care Internal Medicine, UHC campus.
Interview with Dr. William Cobb, MD, infectious disease specialist in Grand Junction, Colorado.
Interview with Elissa Passiment, Executive Vice President, American Society for Clinical Laboratory Science, Bethesda, Maryland.
AACC Government Affairs Update, June 2001, quoting from a presentation by Judith Yost of Centers for Medicare and Medicaid Services on June 14, 2001, at a meeting of the Food and Drug Administration's Blood Product Advisory Committee.
Diagnostics Enable Medical Information Age; Improving Health Care Decisions. Presentation by AdvaMed to the House of Representatives, May 11, 2006. Available online at http://www.advamed.org/publicdocs/news_event_ald_act2006.shtml through http://www.advamed.org.
Forsman, Rodney. The Value of the Laboratory Professional in the Continuum of Care. Clinical Leadership & Management Review. November/December 2002. Pp 370-373.