Non-waived Testing - Competency

Is it required to use all six methods of competency assessment specified in the CLIA regulations for every non-waived test?

Any examples are for illustrative purposes only
Yes, competency assessment for non-waived testing must include all six methods, as applicable to the test system.
The six elements include:
  • Direct observation of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing and testing*.
  • Monitoring, recording, and reporting test results.
  • Review of intermediate test results or worksheets, quality control, proficiency testing, and preventive maintenance performance.
  • Direct observation of instrument maintenance function checks and calibration.
  • Test performance as defined by laboratory policy (for example, testing previously analyzed specimens, internal blind testing samples, external proficiency, or testing samples).
  • Problem-solving skills as appropriate to the job.
Leaders have the flexibility to rely upon their routine quality surveillance activities conducted throughout the year to satisfy one or more of the six methods. Whether the assessment process is conducted all at one time or on an ongoing basis, it should be clearly evident in the associated forms and policies that all applicable methods were used. It is not necessary to document all six methods for each individual analyte; documentation by test platform is adequate if the content of the assessment is clear. Platform is defined as tests performed and interpreted by the same or similar processes. For instance, all tests performed on a specific chemistry or hematology instrument.

*Due to the significant challenges associated with performing direct observation of patient testing, maintenance function checks, and calibration for either a large number of point-of-care testing personnel or for testing performed in a surgical area, the use of a skills demonstration is an acceptable option in these cases.

Competence to perform moderate complexity testing must be assessed by an individual qualified as a technical consultant. Please refer to the CLIA regulation 42 CFR 493.1405 for additional information.

Competence to perform high complexity tests must be assessed by an individual qualified as a technical supervisor.
Please refer to the CLIA regulation 42 CFR 493.1443 for additional information.

This FAQ does not apply to waived testing. Please refer to the Waived Testing standards for the specific competency assessment requirements.
Last updated on September 16, 2020
Manual: Laboratory
Chapter: Human Resources HR

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