Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver Project Announcement for 2011 and Web Resources for CLIA
The purpose of this memo is to inform laboratories and providers holding a CLIA certificate of waiver about the start of the Federal Fiscal Year (FFY) 2011 federal project for facilities and to also provide a link to a web resource for CLIA-related questions and answers.
Federal requirements, 42 CFR, Part 493.37, for a CLIA certificate of waiver, which can be found at http://wwwn.cdc.gov/clia/regs/toc.aspx. State laboratories holding this type of certificate "must permit announced or unannounced inspections by Health and Human Services (HHS)."
Since 2002, the Wisconsin CLIA section has participated in the federal project to visit a small percentage of laboratories holding a certificate of waiver. The purpose of this project is to evaluate testing practices and to provide technical assistance to those laboratories where test quality concerns are identified. The on-site time is expected to be one to two hours in length.
A discussion about the survey findings and information about how to correct any problems affecting test results will be provided at the conclusion of the survey. It is our intent that the focus of these inspections be educational only; however, if any serious risk to human health is identified, we may have to pursue further action as outlined in the CLIA State Operations Manual.
A CLIA surveyor staff person will contact the selected laboratories or providers approximately two weeks prior to the intended survey date. Your laboratory or provider will not be charged for this survey. If you are no longer performing testing, please contact the CLIA section as soon as possible.
Additionally, we anticipate that you may have questions about this project. A Question and Answer (Q&A) document has been posted on the CLIA web page at: http://www.dhs.wisconsin.gov/rl_dsl/Labs/LABSintro.htm
If you have specific questions about this memo or questions about the project, answers to which are not found on the Q&A document on the above website, please contact the CLIA Section at (608) 261-0653 or firstname.lastname@example.org.
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Last Updated: September 30, 2011