If your organization wants to start conducting waived high complexity or simple tests for patients in the United States, Federal Law requires that your site obtains a Clinical Laboratory Improvement Amendment which is a Certificate of Waiver (CLIA). This certificate allows your organization to test patients on-site or at the point-of-care (POC) for mobile and/or off-site testing. Your organization must have a CLIA certificate in place for purchasing these test from MDSupplies. If you currently do not have one, not to worry, here's how to obtain a CLIA Certificate of Waiver!
STEP 1: Know what you can test for
Understand what you can test for when you have a CLIA Certificate of Waiver. You can visit the CDC's website for current waived analytes. Check the list of test kit manufacturers with an FDA emergency use authorization, for example; COVID Tests. There will be a in the column titled Authorized Settings for any test to be performed in a CLIA-waived laboratory.STEP 2: Download and complete the application
Download the CMS-116 Application Form, here! https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdfSTEP 3: Submit the application
Submit your completed CMS-Form 116 application to the appropriate State Agency where your testing site will be located.STEP 4: Pay the applicable fees
Once your application has been submitted, you will receive your CLIA Identification Number along with instructions on submitting your certificate fees. Once your fees are paid your certificate will be sent to you.STEP 5: Receive the CLIA Certificate and Begin Testing
You will receive a 10-digit certificate number. Test manufacturers, including MDSupplies, will require your certificate number when placing an order for testing supplies.STEP 6: Maintain the CLIA Certificate
Maintain a valid and current CLIA Certificate every two years.More Information:
How to obtain a CLIA Certificate of Waiver:Clinical Laboratory Improvement Amendments (CLIA)
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high, moderate, or waived complexity tests. Tests may be authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This page is for informational purposes only. For the most up to date information, please visit: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA.