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What is the CLIA?

If your medical organization performs laboratory tests on site, you should be familiar with Clinical Laboratory Improvement Amendments (CLIA) regulations. Congress passed the CLIA in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed. A laboratory is a facility that performs lab testing on specimens derived from humans for providing information for the diagnosis, prevention, treatment of disease, or impairment or assessment of health.

Three categories of tests have been established:

(1) Waived complexity

(2) Moderate complexity (including the subcategory of provider-performed microscopy (PPM)

(3) High complexity

  • Have a valid CLIA certificate that is appropriate for the type of testing being performed in the office; and
  • If performing PPM tests, it must maintain a Laboratory Procedure Manual and comply with the written procedures and applicable standards mandated by CLIA for the particular laboratory category of the practice.

If a practice performs any laboratory tests or procedures in the office, it should:

CLIA is a user fee-funded program, so all costs of administering the program must be covered by the regulated facilities (i.e., paid through fees assessed to the laboratories for obtaining their certificates, and through fees for testing and inspections).

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