Laboratory and Point-of-Care Testing Personnel - Evidence of Qualifications

For personnel performing laboratory or point-of-care testing, what is required for evidence of their qualifications?

Any examples are for illustrative purposes only.

The Joint Commission standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.

For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.

For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.

When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.

Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.

Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
  • Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
  • HEW Certification
  • State laboratory personnel license
  • Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
Laboratories may use third party services to verify staff credentials. This practice is acceptable if the third party verifies ACADEMIC credentials and is able to provide documentation of such verification within one week of request by the laboratory.
Last updated on June 02, 2020
Manual: Ambulatory
Chapter: Human Resources HR

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