Changes to a CLIA Certificate
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Has anyone gone through the process of converting a CLIA Certificate of Waiver into a CLIA Certificate of Compliance for an outpatient clinic?
What resources are available to prepare for the initial inspection?
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I have done this. What is needed is filling out the CLIA Application for Certification. Under General Information you would check "Change in Certificate Type." In Michigan we have a state website that handles all licensures. This is the site I obtain the application from and send back to. You may want to check if your state has the same or if you need to work directly with the Department of Health and Human Services/CMS. You can search for the application - Form - OMB No. 0938-0581.
Mary Jo Merritt MT(ASCP)
POCC - Henry Ford Health System
I agree it would be beneficial if someone working in Arizona could give insight since states vary in the process.
I did not find resources to help with a COC inspection when I needed something but later fell into the link I inserted below. My system assimilated a Pediatric clinic using a COC. After 2 inspections, we moved to a COW.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf covers 'survey procedures and interpretive guidelines' for state inspectors
Good Luck.