For All Facilities Performing Tests on Human
Specimens: CLIA Requirements
PDF Version of DQA 09-040
(PDF, 39 KB)
For All Facilities Performing Tests on Human Specimens:
Under the authority of Section 353 of the Public Health Service Act, the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) require all
facilities performing tests on human specimens to be certified to perform
these tests. The regulations that implemented CLIA became effective
September 1, 1992.
These regulations also apply to testing performed in facilities without
conventional laboratories, such as care and service residential facilities,
ambulances, health fairs, home health agencies, pharmacies, end stage renal
dialysis facilities, etc.
Collection of blood or other specimens does not require CLIA
certification. Testing specimens is regulated and requires a CLIA
If employees of a facility, or individuals contracted by the facility,
perform testing on human specimens, the facility must have a CLIA
certificate. There are four types of CLIA certificates: Certificate of
Waiver, Certificate for Provider Performed Microscopy Procedures,
Certificate of Compliance, and Certificate of Accreditation. Testing
performed in residential health care settings is generally included in the
tests allowable under the Certificate of Waiver, e.g., whole blood glucose
testing or occult blood testing (stool or gastric).
For questions regarding alcohol and other laboratories, analysts, and the
Clinical Laboratory Improvement Amendments (CLIA), you may e-mail the
Division of Quality Assurance via email@example.com
or phone (608) 261-0653.
CLIA applications (form CMS 116) are also available via the federal CLIA
site at http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf.
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