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U.S. Department of Health and Human Services

Medical Devices

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Follow Good Laboratory Practices with Waived Laboratory Tests

Background:

The Department of Health and Human Services has evaluated laboratory tests for complexity since 1992 as part of the implementation of the Clinical Laboratory Amendments of 1988 (CLIA '88). The more complicated the test, the more stringent the CLIA '88 requirements. Tests designated as high or moderate complexity can be used only by clinical laboratories that comply with CLIA '88 standards for quality assurance, quality control, and patient test management, and personnel. Simple tests designated as waived can be used by laboratories that enroll in CLIA and pay the fee but are exempt from CLIA '88 standards (i.e. community clinics, physicians' offices, or other small laboratories).

By law, waived tests should be simple to use and must provide acceptable results in the hands of untrained users. However, users must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable.

Recommendations for Running Waived Tests:

In order to maximize the performance and reliability of waived tests, laboratories are encouraged to consider the following:

  • Read and follow the information found in the package inserts.
    Small deviations from the written instructions about product storage or procedural steps can have a significant impact on results. Test kits and reagents must be stored under the proper conditions and used prior to their expiration dates. You should take precautions to make sure that the correct reagents are used for each test, and reagents from different test kits are not inadvertently mixed up.
  • Follow the manufacturer's recommendations for running quality control (QC). Many waived tests have built-in quality controls that only monitor certain aspects of the test. In these cases, external quality controls may be the only way to monitor the entire test system. Read the information concerning built-in controls carefully. Manufacturers list minimum frequency requirements for their products in the package insert, but they may not be adequate for all laboratories. Take into account the environment where testing is performed when deciding how often you should run external QC. There are many factors that may be unique to your laboratory that can effect this decision, such as:
    • what information is provided by the built-in control;
    • the extent of safe-guards that are provided with the test system (such as a temperature monitor that alerts you when the test has been stored outside of acceptable limits),
    • the ambient environmental conditions of your laboratory;
    • storage conditions (such as whether the freezer has recycling phases);
    • personnel issues (understaffing or high turnover); or
    • the danger of a false negative test result.
    Select concentrations of control materials to challenge the medical decision points of the test. Selecting a control that has a concentration three times the cutoff concentration of a qualitative test will not allow you to detect reagent deterioration until patient results have already been compromised.
  • Train staff members to perform tests correctly. Make sure your staff is familiar with product operating instructions, quality control procedures, and record keeping. Professional organizations sponsor educational and proficiency testing programs geared toward staff that performs waived tests in outpatient or clinic laboratories. Some training courses are available over the internet.

See Also:

Centers for Medicaid and Medicare Services: CLIA '88 Program

Tests Waived by FDA from January 2000 to Present