COVID-19: Testing Support for Confinement Facilities

When ordering point-of-care antigen tests from DHS, you will need to submit your CLIA Certificate of Waiver number. To obtain a CLIA Certificate of Waiver, you will need to submit a completed application to dhsdqaclia@dhs.wisconsin.gov. 

All COVID-19 testing sponsored by this program needs to occur under the authority of a clinician with prescribing authority (MD, DO, PA, or NP). If you do not have a local clinician who manages your facility’s health services, you can complete the attestation form and submit to WICovidTest@Wisconsin.gov This will allow you to conduct testing under the statewide standing order for COVID-19 tests prescribed by the Wisconsin DHS Chief Medical Officer. 

To submit a request for testing supplies, visit Order free DHS testing supplies 

• Select “Other Organizations”  
• Input the reason for testing in the “Testing Plan” section   
• Select “Correctional Facility/Jail” in the Facility Type  

To receive lab-based molecular tests in the "PCR Testing Supplies" section, enter the clinical laboratory name that you have been paired with (Example: Exact, Mako, Accelerated...)  

• Note: If you have not been paired with a lab, please state in the "Note" section that you need to be paired with a lab  

To order both antigen point-of-care and lab-based molecular tests, complete both PCR Testing Supplies and Antigen Testing Supplies.   

• Note: This option is for facilities paired with EXACT ONLY. Facilities not paired with EXACT need to place separate orders for Antigen and PCR Testing Supplies.  

Any person who will administer COVID-19 testing in the facility must complete training to assure they are using the tests safely and effectively. 

Performing and Reporting Antigen Point-of-care Tests in Facilities 

• Antigen point-of-care testing does not allow for a self-collection option. 
  • How to do a nasal swab video 
  • Reporting antigen point of care results to public health 

Performing and Reporting PCR test in facilities 

• How to complete the PCR swab protocol video
• How to complete the self PCR swab protocol video

COVID-19 is a Category I reportable condition in Wisconsin. As such, test results must be reported to the State of Wisconsin and to federal authorities (HHS). To report results, set up an account. 
 
If you have questions about the COVID-19 testing support available to county jails or municipal lockup facilities, please email dhscovidtestingprogram@dhs.wisconsin.gov.

1. What support is the Department of Health Services providing facilities to conduct COVID-19 testing? The Department of Health Services offers free point-of-care testing supplies with optional confirmatory PCR supplies, shipping and courier services, diagnostic resulting and reporting to state and federal entities for both county jails and municipal lockup facilities. Additionally, county jails will have the option for specimen collection services through an assigned vendor. Tests may be used for PIOC and staff who are symptomatic and close contacts, to conduct screening testing, and to test PIOC who have appointments outside of the facility.
2. Where can I find out additional information about testing in these facilities? If you are a municipal lockup facility interested in ordering supplies or a county jail interested in vendor services or have any general questions regarding COVID-19 testing, email dhscovidtestingprogram@dhs.wisconsin.gov. 
3. Is it mandatory for facilities test PIOC and staff? No, participation i is voluntary. 
4. Will the program offer facilities funding for additional staff in order to conduct testing? No. Direct funding to pay staff is currently not covered under this program. 
5. How do I order point-of-care antigen tests under this program? Free point-of-care antigen tests may be ordered through the Wisconsin COVID-19 Collection Supply Request website. Facilities conducting testing must provide a valid CLIA Certificate of Waiver number during the ordering process. 
6. Is the cost associated with biohazard waste disposal covered under this program? No. The cost of biohazard waste disposal is not covered under this program. Facilities are responsible for safely disposing of waste. For additional information, see CDC Waste Management Guidelines for SARS-CoV-2 Point of care Testing.

1. When does a facility need a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver? For a facility to conduct point-of-care tests (like COVID-19 point-of-care antigen tests or diabetic glucose checks), the facility must apply for and receive a CLIA Certificate of Waiver. Facilities may not conduct testing until the certificate of waiver has been approved. A facility does not need a certificate of waiver if they collaborate with another entity willing to conduct testing at the  facility under that entity’s CLIA Certificate of Waiver or if the  facility is not conducting point-of-care tests. 
2. What responsibilities must a facility fulfill as an organization with a CLIA waiver? Any organization with a CLIA Certificate of Waiver is responsible for the safety and effectiveness of services they provide. For facilities conducting COVID-19 point-of-care testing, this includes staff training, effective infection control practices, and reporting infectious disease test results to the State of Wisconsin and to the federal authorities (HHS). Guidance about how to set up an account and report COVID-19 point-of-care test results is available from the Wisconsin State Laboratory of Hygiene. If a facility coordinates with a testing partner or is providing lab-based molecular tests (not point-of-care tests), then the laboratory will assume the responsibility for the safety and effectiveness of testing – including responsibility for reporting test results on the facility’s behalf. 
3. If a facility uses another company to conduct point-of-care antigen testing, does the facility still need to obtain a CLIA Certificate of Waiver? No. If the facility partners with an entity to come to their facility to swab and result the point-of-care antigen test, then the facility does not need to obtain their own CLIA certificate of Waiver. All testing would occur under the external entity’s CLIA certificate. The t facility should verify that the external entity conducting the test has a valid CLIA Certificate of Waiver. To find out if an entity has a valid CLIA Certificate of Waiver, request the CLIA number from the testing partner and verify it by checking the CDC CLIA Laboratory Search website or emailing dhsdqaclia@dhs.wisconsin.gov. All entities ordering point-of-care antigen test supplies from DHS are required to provide their CLIA number when placing their orders. 
4. How does a facility apply for a CLIA Certificate of Waiver? To apply to receive a CLIA Certificate of Waiver, the facility must fill out the Center for Medicare and Medicaid Services (CMS) application form CMS-116 CLIA Application and submit it to the State of Wisconsin CLIA Section at dhsdqaclia@dhs.wisconsin.gov. Once approved, CMS will assign a CLIA number and send a letter or email of confirmation to the facility. For more information on CLIA certification, reference the CMS Laboratory Quick Start Guide. 
5. How long does it take to process the CLIA Certificate of Waiver? Once a facility submits an accurate and complete application, the Wisconsin State Agency usually processes the Certificate of Waiver in one week or less. Once approved, the facility will be assigned a Federal CLIA number and may begin testing. Provide this CLIA number to DHS when ordering testing supplies. 
6. Is there a fee associated with applying for a CLIA Certificate of Waiver? Yes. An entity is required to pay $180.00 to CMS. CMS will send an invoice to the  facility and they may submit payment to CMS directly or pay online at Pay.Gov. 
7. Does the CLIA Certificate of Waiver expire? The CLIA Certificate of Waiver is good for two years. CMS will send a renewal invoice 6 months prior to the expiration date of the certificate. 
8. The CLIA application asks to identify the "director" of the laboratory. Can this be anyone in the facility? The facility may list any employee as the director on the CLIA Application. It is recommended that the director is an individual who is or who will become knowledgeable about the requirements of maintaining the CLIA Certificate of Waiver and the facility’s testing operations, including testing and safety protocols, staff training, and reporting of test results. Examples may include: the facility nurse, a health aide, or a facility administrator overseeing the health or testing program. 
9. What other information will the application request? The application requires the facility to provide their Tax ID number. The application also requires the facility to estimate the number of tests they plan to conduct. This can be a general estimate based on the number of staff and PIOC. 
10. How can a facility verify whether they already hold a CLIA certificate? To verify whether an entity has a valid CLIA Certificate of Waiver, check https://www.cdc.gov/clia/LabSearch.html or email dhsdqaclia@dhs.wisconsin.gov. 
11. Who do I contact if I have additional questions about the CLIA Certificate of Waiver process? For any questions about the CLIA Certificate of Waiver and process, email the State of Wisconsin Department of Health Services, Division of Quality Assurance at dhsdqaclia@dhs.wisconsin.gov.

1. Who at my facility is allowed to collect the specimen for a COVID-19 test? Does it have to be a nurse? Any staff member who is properly trained is allowed to collect the specimen and result the point-of-care antigen test. Training may be accessed through many venues, including from a trained clinician (a healthcare provider) or through the test manufacturer’s materials. If you need assistance finding these vendor materials, email WICovidTest@Wisconsin.gov. 

2. Does a facility need to have access to lab-based molecular tests? All facilities conducting point-of-care testing under Dr. Westergaard's statewide standing order (including COVID-19 point-of-care antigen tests) must assure compliance with the DHS and CDC recommendation for providing follow-up testing to confirm some antigen results. Lab-based molecular tests are recommended for this follow-up testing. Facilities order and provide these follow-up, confirmatory tests, or refer staff to follow-up: 

   • at a free community testing site

   • at the PIOC health care provider or a free or low cost health clinic for those who do not have a health care home (verify if they are conducting COVID-19 molecular testing prior to referral). 

3. How should facilities prepare to test PIOC and staff on site? Facilities interested in offering onsite testing will need to assure the following: 

   • a process for notifying PIOC and staff of their results

   • necessary testing supplies including personal protective equipment, tables, and cleaning and disposal supplies

   • space to isolate PIOC with symptoms and who test positive

4. Should facilities require a negative test result for PIOC to return to the general population or staff before returning to work after they have been sick? No. It is not recommended to require a negative test before returning. There have been reports that PIOC and staff can continue to test positive long after they are no longer contagious. PIOC and staff who test positive should observe a 10-day isolation period from the date their symptoms first appeared. Additionally, they need to be fever-free for 24-hours and have improved symptoms before they end their isolation period. Asymptomatic PIOC and staff should observe a 10-day isolation period starting on the date that symptoms began or the specimen collection date if they did not have symptoms. 

   For additional guidance on this topic: 

   • Learn about medical isolation and quarantine

   • Contact your local tribal health department 

   • See CDC Testing in Correctional & Detention Facilities guidance

5. When should a PIOC be referred for diagnostic testing?  

   • PIOC with symptoms, regardless of COVID-19 vaccination or booster status, should be moved to medical isolation in a separate environment from other people (ideally individually), medically evaluated, and tested. If the test result is positive, medical isolation should continue for 10 days. Multiple PIOC with confirmed COVID-19 can be housed as a cohort (in a dorm or cell environments) regardless of the date of their positive test result. Facility staff should carefully evaluate and support the mental health needs of PIOC during medical isolation. If PIOC test negative and did not have close contact with a suspect or confirmed COVID-19 case, then he/she can end isolation. 

   • Staff members with symptoms, regardless of COVID-19 vaccination and booster status, staff should be excluded from work and are advised to seek testing. If the test result is positive, staff members should be excluded from work for 10 days (However, staff may use the guidance for the general public for duration of isolation when they are not at work). See section below on isolation duration for staff during routine vs. crisis operations. If staff test negative and did not have close contact with a suspect or confirmed COVID-19 case, then he/she can end isolation.

   • Visitors with symptoms, regardless of COVID-19 vaccination and booster status, should be denied entry and encouraged to seek testing through their healthcare providers, at a free community testing site or local health department.

1. Does a facility participating in this state-sponsored program need an order signed by a medical provider to do testing? Yes, COVID-19 testing sponsored by this program needs to occur under the authority of a medical provider. A facility may obtain a written order through a clinician with prescribing authority (MD, DO, PA, or NP), or opt to use a standing order issued by Dr. Ryan Westergaard, Chief Medical Officer for the Wisconsin Department of Health Services. If a facility chooses to use Dr. Westergaard’s standing order, they must sign an attestation form agreeing to follow the requirements of the order.