Competency Assessment - Non-Waived Testing

Who can conduct the direct observation of test performance and instrument maintenance that is required when assessing competency of individuals performing non-waived testing?

Any examples are for illustrative purposes only.

The qualifications of the individual(s) who can perform test and maintenance direct observations for the competence assessment on non-waived testing personnel are defined by CLIA regulations and CMS guidance.  The qualifications of the observer of high complexity testing differ from those who observe moderate complexity testing.

The competence for performing high complexity testing including direct observations must be performed and assessed by an individual qualified as a  technical supervisor or delegated in writing to an individual  qualified as general supervisor.

The competence for performing moderate complexity tests including direct observations must be performed and assessed by an individual qualified as a technical consultant.  Responsibilities may not be delegated to a general supervisor.  

References:
  • The qualifications required for the role of technical supervisor can be found at CLIA regulation 42 CFR 493.1449.
  • The qualifications required for the role of general supervisor can be found at CLIA regulation 42 CFR 493.1461.
  • The qualifications required for the role of technical consultant can be found at CLIA regulation 42 CFR 493.1411.
Last updated on February 08, 2021
Manual: Laboratory
Chapter: Human Resources HR

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