Lab Oversight: A Building Block of Trust

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It’s one of the most common phrases you hear from your health care practitioner: “I just want to run a few tests.”
Laboratory tests are among the most important and pervasive aspects of modern medicine. The results of clinical laboratory tests contribute to the majority of healthcare decisions. Laboratory tests provide healthcare practitioners with the information for decisions from diagnosis through therapy and determining outlook (prognosis). For some conditions, there is just no substitute for a laboratory test. For example, high cholesterol can be identified through laboratory work long before any symptoms might appear.
Healthcare practitioners rely on the laboratory for help in diagnosing any number of conditions and for managing their treatment. They trust the results that laboratories produce. But you’ve probably seen headlines or heard stories about patients who suffered dire consequences, such as unnecessary surgery or even death, as a result of inaccurate laboratory test results or incorrect interpretation of the results. So, a reasonable question for any patient is: should I trust my laboratory results?
The short answer is yes, you can have as much trust in these results as your health care practitioner does. There are many protections in place to ensure that laboratories produce reliable results. These have been instituted by federal and state government, laboratory accrediting organizations, and individual laboratories themselves to help maintain standards of quality. In addition, there are steps that you personally can take to further increase your comfort with the quality of your laboratory results, including questions that you can ask your healthcare practitioner.
Regulations: The Key Players
Key Components of Lab Oversight
Additional Resources
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. There is also a demographic lookup that you can use to find out what type of CLIA certificate the laboratory has.
- To see sample inspection checklists used for laboratory inspections, visit the College of American Pathologists site
- To see which tests are classified as waived (called “waived tests” because CLIA requirements have been waived for them), visit the 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.
View Sources
This article was originally written by Eric Seaborg.
Sources Used in Current Review
(Enacted December 31, 2018) The Public Health Services Act, 353 (d) (3). Available online at https://legcounsel.house.gov/Comps/PHSA-merged.pdf. Accessed February 2019.
(February 2019) Centers for Disease Control and Prevention. CLIA Law and Regulations. Available online at https://wwwn.cdc.gov/clia/Regulatory/default.aspx. Accessed February 2019.
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.
Forsman, Rodney. The Value of the Laboratory Professional in the Continuum of Care. Clinical Leadership & Management Review. November/December 2002. Pp 370-373.
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/. Accessed September 2015.