Clinical Laboratory Improvement Amendment (CLIA)
WV State CLIA Program
Congress passed CLIA in 1988 establishing quality standards for all laboratory testing performed on humans (clinical) to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The regulations are based on the complexity of the test method. The Centers for Medicare and Medicaid Services (CMS) is the federal agency given oversight of the CLIA program. The state agencies administer the program following the federal guidelines.
CLIA FEES
Do not submit CLIA fees to the WV Office of Laboratory Services. Note the North Carolina address on CLIA bill. For more information on WV laboratories call 558-3530 Ext 2103.
FORMS AND INSTRUCTIONS
CLIA Application Forms:
CLIA Application (116 form) - This form is to be completed on each new WV clinical laboratory seeking CLIA compliance or if a current WV laboratory makes a change in name, director, location (within 30 days); addition of deletion specialty or certificate type (within 6 months).
WV Form - Annual Test Volume Log
Guidelines for counting tests (instuctions and form)
RESOURCE LINKS
CLIA Interpretive Guidelines - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.
Certificate of Waiver Rules & Regulations
Center for Medicare and Medicaid (CMS) - Federal CLIA website - Information available on current CLIA news, updated regulations, list of waived and nonwaived tests, certificate types, CMS regional offices, fee schedules, and approved proficiency testing providers.
CLIA Database - Search for test complexity.
CONTACT INFORMATION
WV Office of Laboratory Services (WV State Agency)
Attn: CLIA Program
167 Eleventh Avenue
South Charleston, WV 25303
Ph. 304-558-3530
Fx. 304-558-2006
Jerry Gross, CLIA Coordinator
jerrygross@wvdhhr.org
Ph. 304-558-3530 x2103
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Applications & Disclosure of Ownership Forms
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HCFA 209 Personnel Reports
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Fee questions (no collections)
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Change of complexity status
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Changes in address, director or testing
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CPT code questions
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Schedule survey
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Issue Complaint
Ruth Lynd, MT (ASCP)
CLIA Inspector
ruthlynd@wvdhhr.org
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Laboratory testing technical questions
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Complaints
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Questions concerning recent inspection of your laboratory
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Test complexity
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Personnel Licensure questions
Sharon Cibrik, MT (ASCP)
Supervisor
sharoncibrik@wvdhhr.org
304-558-3530 x2107
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Laboratory testing technical questions
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Test complexity
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Questions concerning recent inspection of your laboratory
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Test Complexity
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Personnel Licensure Questions
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Complaints/concerns
