Understanding CLIA – Part 1

What is CLIA?  CLIA or the Clinical Laboratory Improvement Amendments where first published in 1967 requiring laboratories serving as providers in the Medicare program to be subject to quality standards. This first amendment covered rules for personnel standards applied only to applicable “free-standing” facilities (independent laboratories).  In 1988, Congress enacted CLIA’88 sparked by the significant problems in cytology “Pap” smears testing that resulted in deaths, and the increase of testing in unregulated physician offices. Regulated by three federal agencies CLIA establishes the quality standards for laboratory testing of human specimens (blood, body fluid and tissue), for the purpose of diagnosis, prevention or treatment of disease.”  It requires all clinical laboratories to be certified by their state as well as CMS prior to accepting any human samples for testing.   CLIA defines a laboratory as “any facility that examines human specimens for the diagnosis, prevention and treatment of any disease or impairment of, or the assessment of the health of, human beings.” Research and forensic laboratories are excluded.

According to the US Department of Health and Human Services, there are three federal agencies responsible for CLIA, each having a different role in assuring quality: Food and Drug Administration (FDA), CMS and the Centers for Disease Control (CDC).

The FDA’s role is to categorize, review request and develop rules for tests based on complexity.  CMS issues laboratory certificates, collect fees and conducts inspections. The CDC develops technical standards and laboratory practice guidelines and monitors proficiency testing practice to name a few.

The FDA uses a “scorecard” to determine the complexity of a particular test.  This scorecard is based on the following considerations:

  • Knowledge needed to perform the test
  • Training and experience required to perform the test
  • Reagents and materials preparation
  • Characteristics of operational steps
  • Calibration, quality control, and proficiency testing materials
  • Test system troubleshooting and equipment maintenance
  • Amount of interpretation and judgment

Tests are then categorized as waived, moderate and high complexity.  CLIA certificates are then issued based on the test complexity. 

  • Certificate of Waiver – includes test cleared by the FDA for home use or test simple enough to have low risk for erroneous results.
  • Certificate for Provider-Performed Microscopy Procedures (PPMP) – issued to facilities that perform a limited list of tests requiring microscopic procedure for example pinworm examinations, wet mounts, urinalysis.
  • Certificate of Registration – initially issued to laboratories that apply for a Certificate of Compliance or Accreditation, performing moderate to high complexity testing until the initial survey is performed and the laboratory is found to be in compliance with all CLIA regulations
  • Certificate of Compliance – issued after the initial inspection is conducted by the state’s department of health, which allows the laboratory to perform moderate and high complexity testing.
  • Certificate of Accreditation – similar to the certificate of compliance.  However, inspections are conducted by the accreditation organizations.

There are currently 14 sub-parts to the regulations.  Subpart A details general provisions for laboratories performing each type of testing complexity. Subpart B and C detail the process for applying certificates of waiver, PPMP and compliance, while Subpart D and E address the certificate of accreditation and accreditation by a private non-profit organization or exemption under an approved state laboratory program.  Subpart F describes general administration, such as certificate fees and methodology for determining fee amount. Subpart H and I deals with proficiency testing for laboratories performing non-waived testing.  Subpart J describes the standards for facility administration for non-waived testing. Subpart K describes the conditions and standards of quality systems for non-waived testing. Subpart M detail the conditions and standards for personnel performing non-waived testing. Subpart Q and R deal with inspections and enforcement of the regulations.  Lastly Subpart T defines the establishment and function of the Clinical Laboratory Improvement Advisory Committee.

Next week we will look into the quality system as set forth in the regulations.