Laboratory inspection
This article was last reviewed on
This article waslast modified on
December 20, 2017.

It's one of the most common phrases you hear from your healthcare provider: "I just want to run a few tests."

Laboratory tests are among the most important and pervasive aspects of modern medicine. The majority of healthcare decisions are derived from clinical laboratory tests. Laboratory tests provide health practitioners with the information for decisions from diagnosis through therapy and prognosis.

"There's scarcely a patient in my practice who hasn't had lab tests," says Dr. Scott Luria, an internal medicine physician and associate professor at the University of Vermont. 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 providers 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 healthcare provider does. There are many protections in place to ensure that laboratories produce reliable results. These have been instituted by federal and state government, laboratory professional 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 provider.

Accordion Title
About Lab Oversight
  • Regulations: The Key Players

    The key participants in the quest for laboratory quality have been the federal and state governments and the laboratory professional community. Very briefly, their roles are as follows:

    • Federal Government – All laboratories that perform tests on "specimens derived from humans for the purpose of providing information for the diagnosis, prevention, and treatment of disease" fall under the Clinical Laboratory Improvement Amendments (CLIA). This means that if your healthcare provider wants to run a blood test or urinalysis, or asks you for a stool or sputum sample, then CLIA will influence how these samples are handled and how the tests are performed.

      Passed by Congress in 1988, the CLIA amendments were adopted to ensure the accuracy, reliability, and timeliness of patient test results. CLIA covers testing in all U.S. states, and every clinical laboratory in the country must obtain a certificate that defines the complexity of tests that the particular laboratory can perform.

    • State Government – Several states have additional requirements that are equal to or more stringent than those outlined in the CLIA regulations. In these cases, the state, not the federal government, assumes primary responsibility for oversight of laboratory practices. This situation can occur only after the Centers for Medicare and Medicaid Services (CMS) have "deemed" the state requirements to be equal to or more stringent than the CLIA requirements.
    • Laboratory Professional Organizations – The most visible line of defense for accurate results is federal regulation, but the foundation for this regulatory system is the voluntary self-policing systems developed by laboratory professionals and their organizations.

      Two professional organizations, the College of American Pathologists (CAP) and The Joint Commission, had stringent, voluntary laboratory accreditation programs many years before the government required it. Today, both organizations continue to offer highly respected laboratory accreditation programs. Other organizations, such as the Clinical Laboratory Standards Institute (CLSI), a globally recognized, standards-developing organization, are involved in improving medical testing through the development and dissemination of standards, guidelines, and best practices.

  • Laboratory Inspections

    To make sure that laboratories are following the requirements outlined in CLIA, state law, and/or the rules established by the professional organizations to qualify for their accreditation, laboratories also must undergo regular inspections every two years. Several particularly important areas for inspection are leadership, personnel training and competency requirements, proficiency testing, performance improvement, and quality control requirements. For the most part, these inspections are unannounced to eliminate any opportunity for the laboratory to "ramp up" for the inspection. Unannounced inspections assure that the laboratory is in a continual state of readiness to provide safe, quality care to all patients.

    • Education and Training Requirements – There are many roles to fill in a laboratory, and both the voluntary systems and the federal regulations spell out educational requirements for laboratory personnel, such as the minimum educational level that a person must have in order to perform each laboratory test. In addition, laboratory personnel may be certified for their profession, obtained through successful completion of the national certification exam. Some state and other federal regulations also require that the laboratory staff participate in documented continuing education. (For more information on laboratory personnel, their various roles and education requirements, read our article Who's Who in the Lab.)
    • Proficiency Testing – Laboratories that perform the kinds of tests typical of a hospital laboratory participate in a proficiency testing (PT) program. For this program, an outside agency approved by the federal government checks on the accuracy of the laboratory's test results by sending test samples to be analyzed. The outside agency knows the levels of the substances, or analytes, contained in the samples – the sodium level, for example – but the laboratory does not. PT includes samples for each specialty and subspecialty area in which the laboratory performs testing. The laboratory must test the samples the same way it would test patients' specimens. The outside agency uses PT to grade the laboratory's accuracy. Laboratory inspectors verify that the lab has an acceptable score in an approved PT program.
    • Quality Control – To ensure the quality of the results, clinical laboratories test "control" samples along with the patient samples. The laboratorians know what these control samples contain, so the samples provide a built-in check on the process of analysis, which in many cases is carried out by an automated instrument called an analyzer. The control samples contain high and low concentrations of the analyte being measured, to make sure the analyzer is running correctly across the range of concentrations the patient samples may contain. If the results vary from the known quantities, the laboratorians know there is a problem. The problem identified must be corrected before patient testing can be reported. Laboratory inspectors also examine these records during their evaluations.
    • National Patient Safety Goals – The goals highlight problematic areas in the laboratory and describe evidence and expert-based solutions to these problems. The purpose of these National Patient Safety Goals is to promote specific improvements in patient safety. For example, correct patient identification is one of the goals that must be met throughout the process for specimen collection, analysis, and result reporting.
  • Your Role

    CLIA regulations create a "level playing field" in which all laboratories must meet appropriate criteria in competing with each other. However, the quality of services still varies among laboratories. To ensure that you are receiving the best quality services, there are steps you can take to check for yourself.

    • Your first consideration is the kind of laboratory that will be testing your specimen. Most physician office laboratories run only simple tests. These are called waived tests because they are exempt from the more stringent standards applied to the "complex" tests performed in larger, full-service laboratories. There are no education or training requirements for the personnel in physician office laboratories, so ask your healthcare provider about the qualifications of those staffing the laboratory. Also ask if the laboratory participates in any outside education or quality checking programs.
    • The major requirement for physicians' offices that perform only simple tests is that they follow the manufacturer's instructions for the tests, but a recent U.S. Health and Human Services Department study found that nearly one-half failed to do so. Can the person who will perform your test explain to you the specified procedures? Is the laboratory following proper specimen labeling and handling procedures (for example, was your specimen labeled with your name in your presence)?
    • If your tests will be run by a larger, more complex laboratory, it will undoubtedly fall under the CLIA accreditation requirements, but you still might like reassurance about its quality. Ask your healthcare provider about what considerations went into the choice of the laboratory. What criteria did your healthcare provider use? How long has your provider been dealing with this laboratory? How is your provider assured of the accuracy of the test results?
    • The sample collection process itself should provide you some clues: was the specimen properly labeled? Were you given clear and adequate instructions if you collected the sample yourself? When you have blood drawn, you can ask to see the labeled collection tubes before they are taken away. That way you can verify that your information is on the correct tube(s). The person collecting your sample should always verify your identity. This is why, even if they know you, they may ask you to verify your name and date of birth.
    • Is your healthcare provider aware of the laboratory's accreditation status? Because laboratories are so closely regulated, if you'd like reassurance on the laboratory's accreditation and certification, you can check this yourself by visiting various web sites. The U.S. Centers for Medicare and Medicaid Services posts a list of accredited laboratories as well as those that have had some trouble. Through the links listed in Related Content below, you can find other inspection and certification agencies that might have further information on the laboratory you're interested in.
Related Content
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.

View Sources

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. To access online sources, copy and paste the URL into your browser.

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/. 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.

Forsman, Rodney. The Value of the Laboratory Professional in the Continuum of Care. Clinical Leadership & Management Review. November/December 2002. Pp 370-373.