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Lab Oversight: A Building Block of Trust

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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 on the Related Pages page for this article, you can find other inspection and certification agencies that might have further information on the laboratory you're interested in.

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