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QRTI Newsline --- Wednesday September 8, 2010

When is a CLIA Certificate Required?

The information below is copied directly from the CLIA website and is provided here to answer some of the basic questions on lab certification requirements. Please see the link at the end of this abstract for further information.

NOTE: Congress passed the Clinical Laboratory Improvement Amendments (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. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April, 24, 2003.

DO I NEED TO HAVE A CLIA CERTIFICATE?

CLIA requires all facilities 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" to meet certain Federal requirements. If a facility performs tests for these purposes, it is considered a laboratory under CLIA and must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed. WHAT ARE THE DIFFERENT TYPES OF CLIA CERTIFICATES AND HOW LONG ARE THEY EFFECTIVE?

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

Certificate of Waiver (COW): Issued to a laboratory that performs only 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 (COC): Issued to a laboratory once the State Department of Health conducts a survey (inspection) and determines that the laboratory is compliant with all applicable CLIA requirements. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
Certificate of Accreditation (COA): 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.

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

Contact information for the above CMS-approved accreditation organizations is available on the CMS CLIA web site at
http://www.cms.hhs.gov/clia.
If you apply for accreditation by one of the CMS-approved accreditation organizations, you must also apply to CMS for a COA concurrently. http://www.cms.hhs.gov/CLIA/downloads/HowObtainCLIACertificate.pdf