When planning to provide COVID-19 testing services in Wisconsin, there are some important steps you will need to take:
1. Decide what type of testing you will be providing and have the correct Clinical Laboratory Improvement Amendments (CLIA) certification required to provide that type of testing.
Clinical Laboratory Improvement Amendments (CLIA) are federal regulations for diagnostic laboratory testing to ensure accuracy, reliability and timeliness of test results, regardless of who performs the test and where they are performed.
Entities conducting diagnostic COVID-19 tests are required to have a CLIA certificate. There are different types of certificates depending on the test complexity. Most entities performing rapid testing only need a CLIA Certificate of Waiver. Tests that are eligible for use under a certificate of waiver includes those that are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result,” as determined by the Food and Drug Administration.
Consult these resources to learn if the type of testing you’ll be providing requires a CLIA certificate of waiver or a higher complexity certificate:
A CLIA certificate is not required when:
- The tests are authorized by the FDA for home use and performed by the end user,
- The tests are used for surveillance purposes only and not reported to the patient or medical provider.
- You distribute the supplies or collect the samples but do not perform the testing on-site.
2. Apply for a CLIA certificate.
To apply for a CLIA certificate, fill out the Center for Medicare and Medicaid Services (CMS) application form and submit it to the State of Wisconsin CLIA Section at DHSDQACLIA@wi.gov. Follow the CLIA COVID Quick Start Guide instructions to complete the application.
Once you submit an accurate, complete application, approval generally takes a week or less. When CMS approves your application, they will assign a CLIA number and send a letter or email of confirmation. CMS will send you an invoice for the $180 fee. You can mail the fee directly to CMS or pay online.
A CLIA Certificate of Waiver expires after two years. CMS will send a renewal invoice six months before the certificate’s expiration date.
More information is available from CMS about obtaining a CLIA Certificate of Waiver.
3. Understand and follow the requirements for coordinating with a testing partner, or providing lab-based molecular tests (not point-of-care tests).
If you use a contracted service (public health nurse, private nurse, testing vendor) to conduct the testing, they will need to obtain a CLIA Certificate of Waiver if they do not already have one. To verify that an entity has a valid CLIA Certificate of Waiver, check the Centers for Disease Control and Prevention's (CDC) CLIA Laboratory Search website or email DHSDQACLIA@wi.gov.
The contracted service assumes responsibility for the safety and effectiveness of testing, including reporting test results on a facility’s behalf. The entity that holds the CLIA certificate must identify a laboratory director who attests they are responsible for the training and supervision of staff performing the testing, and that they are following the manufacturer's instructions for the test.
For questions about testing or certification requirements in Wisconsin, email DHSDQACLIA@dhs.wi.gov.
4. Set up an account to report COVID-19 test results.
The Department of Health Services (HHS) requires your facility to report COVID-19 according to current guidelines (updated April 4, 2022). State statutes require reporting of category 1 diseases each day within 24 hours of testing, including COVID-19. More information about disease reporting in Wisconsin is available.
To set up an account to simultaneously report to HHS, state, and local health departments through web-based lab reporting (WLR), register for a HIPPA compliant account. You will need to know your CLIA certificate number at the time of registration. Questions about WLR can be directed to email@example.com.
5. Communicate with the local or tribal health department in the area where you are providing testing services.
The local or tribal health department in the area where you will be providing testing services is an important partner.
Let them know:
- The type of testing you will provide
- The location of your testing site
- The days and hours when testing will be offered
- That you are aware of and will be following reporting requirements
- Who the contact person is at your site in case there are questions or concerns
- Whether you will be billing insurance
- Whether there is a testing fee, and if so, what that fee is
- To add you to the COVID-19 Community Testing Site map
- COVID-19 Certification, Testing, and Result Reporting: Recorded presentation by Angela Mack, Division of Quality Assurance, Wisconsin Department of Health Services, and Dr. Alana Sterkel, Wisconsin State Laboratory of Hygiene
- Centers for Medicare and Medicaid Clinical Laboratory Improvement Amendments (CLIA) webpage
- How to Obtain a CLIA Certificate of Waiver (PDF): Guide from Centers for Medicare and Medicaid Services and Department of Health and Human Services
- Ready? Set? Test! (PDF): CDC guidance booklet on performing waived laboratory testing
- Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing: CDC guidance on COVID-19 testing
- Web-Based Laboratory Reporting (PDF): Instructions from Wisconsin Department of Health Services on how to set a web-based laboratory reporting (WLR) account
Order COVID-19 testing supplies: Order supplies through the State of Wisconsin (eligibility criteria apply)