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CLIA certification

CLIA certification is the requirement under the Clinical Laboratory Improvement Amendments of 1988 that all entities that perform even one test, including waived tests, on … “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA certification application collects information about a medical laboratory’s operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

All types of CLIA certifications are effective for two years, and the different types of certificates are:

  • Certificate of Waiver – Issued to a laboratory that performs only CLIA waived tests
  • Certificate for Provider Performed Microscopy (PPM) procedures – Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of microscopy procedures is included under this certificate type and these are categorized as moderate complexity.
  • Certificate of Registration – Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
  • Certificate of Compliance – Issued to a laboratory after an inspection by the state Department of Health that finds the laboratory to be in compliance with all applicable CLIA requirements
  • Certificate of Accreditation – Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.

There are six CMS-approved accreditation or organizations:

  • AABB
  • American Osteopathic Association
  • American Society of Histocompatibility and Immunogenetics
  • COLA
  • College of American Pathologists (CAP)
  • Joint Commission on Accreditation of Healthcare Organizations

Laboratories that apply for accreditation by one of the CMS-approved accreditation organizations must also apply to CMS for a COA at the same time. Laboratories must apply for the highest-level CLIA certification that covers the tests they perform.
Any laboratory located in a state that has a CMS-approved laboratory program is exempt from CLIA certification. Currently, there are two states with approved programs: Washington and New York (partial exemption).

If CMS or the State Agency receives a complaint against a laboratory, the laboratory may receive an unannounced on site survey, even though it only perform waived tests or PPM procedures.

The following exceptions to CLIA certification apply regardless of a laboratory’s location:

  • Any laboratory that only performs testing for forensic purposes
  • Research laboratories that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients
  • Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. However, a CLIA certification is needed for all other testing conducted by a SAMHSA-certified laboratory.

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