For All Facilities Performing
Tests on Human Specimens: CLIA Requirements
PDF Version of BQA 03-008 (PDF,
19 KB)
Date: May 7, 2003 -- BQA Memo 03-008
Supersedes memos 99-013 and 00-082
From: Jane Walters, Chief, Health Services Section
cc: Susan Schroeder, Director, Bureau of Quality Assurance
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
certificate.
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, or to obtain an application for CLIA certification,
please contact the Clinical Laboratory Unit, (608) 261-0653 or E-mail the
Bureau of Quality Assurance via Plicclia@dhfs.state.wi.us.
CLIA applications (form CMS 116) are also available via http://cms.gov/forms/
(exit DHFS - address updated).
The federal CLIA site at http://cms.hhs.gov/clia/
(exit DHFS - address updated) may also be useful.
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