symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. 16. Are nursing homes required to report results of any COVID-19 tests? Yes. All laboratories must have a CLIA Certificate and report the results of the COVID-19 tests that they conduct to the appropriate federal, state, or local public health agencies. Laboratories must report data for all testing completed, for each individual tested. This data must be reported within 24 hours of test completion, on a daily basis, to the appropriate state or local public health department, based on the individual’s residence. Testing sites must report all diagnostic test data in accordance with the HHS Lab Data Reporting Guidance for COVID-19 issued June 4, 2020 and meet these reporting requirements by August 1, including providing your facility name and CLIA number when reporting results. Please visit the CDC website for more information about data reporting requirements. 17. Can nursing homes keep the testing platforms? Yes. Upon receipt, the instrument(s) become the property of the nursing home and can be used in accordance with the conditions of authorization for the test. 18. How should facilities handle indeterminate results? Quidel Sofia 2: If the test does not flow correctly, Sofia or Sofia 2 will indicate that the result is invalid. Should this occur, review the procedure and repeat the test with a new patient sample and a new Test Cassette. BD Vertior: The test results could be ‘positive’, ‘negative’, or ‘invalid’. If the test is invalid, the BD Veritor System Instrument will display “CONTROL INVALID” and the test (or control) must then be repeated. Do not report results. Repeat the test. 19. Do facilities need a provider order to conduct the test? These are prescription use tests under the Emergency Use Authorization and must be ordered by a healthcare professional licensed under the applicable state law or a pharmacist under HHS guidance. 6/8 | Page 20. How should the materials be stored when they arrive? For BD, kits may be stored at 2 to 30°C. Reagents and instruments must be at room temperature (15 to 30 °C) when used for testing. DO NOT FREEZE. For Quidel, kits may be stored at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable until the expiration date printed on the outer box. DO NOT FREEZE. 21. Does a Skilled Nursing Facility/ Nursing Facilities need a CLIA (Clinical Laboratory Improvement Amendments of 1988) Certificate of Waiver in order to perform testing of specimens for COVID-19? A Skilled Nursing Facility/ Nursing Facility needs a CLIA certificate, which can be a Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation, to perform COVID-19 testing of specimens authorized by the FDA to be used in Point of Care settings (i.e., in patient care settings operating under a CLIA Certificate of Waiver) or Waived settings. Under CLIA, facilities are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. To become CLIA-certified, facilities must comply with the accuracy, quality, and reliability requirements as provided by the statute (CLIA Statute). The purpose of these requirements is to ensure that the test results that patients or their health care providers receive are accurate and reliable. Laboratories that wish to become CLIA certified must apply for a CLIA certificate. If you would like to apply for a CLIA Certificate of Waiver, please refer to the brochure, How to Apply for CLIA Certificate of Waiver and submit your application form (CMS Form 116) to the state (CLIA State Agency Contacts) where the laboratory is located. If you would like to apply for a CLIA certificate that will allow you to perform more complex tests, please refer to the brochure, How to obtain a CLIA Certificate. 22. I understand that HHS will be distributing tests and test systems to Skilled Nursing Facilities/ Nursing Facilities. What type of CLIA certificate would my facility need in order to perform this testing? HHS will be distributing tests that are authorized for use at the Point of Care (POC) or inpatient care settings operating under a CLIA Certificate of Waiver. Your facility would be required to have a CLIA Certificate of Waiver. 23. How do I apply for a CLIA Certificate of Waiver so that my Skilled Nursing Facility/ Nursing Facility can perform COVID-19 testing? While the CLIA program is a Federal program, it contracts with State Agencies (CLIA State Agency Contacts) to carry out certain oversight and recording functions of the CLIA program. The State Agency in the state where the laboratory (meaning, any facility that is 7/8 | Page CLIA-certified such as a nursing home that performs point of care or waived testing) is located can answer your questions and will process your application. You may need to consult with your State Agency (CLIA State Agency Contacts) for further guidance regarding any state requirements. If you would like to apply for a CLIA Certificate of Waiver, please refer to the brochure, How to Apply for CLIA Certificate of Waiver and submit your application form (CMS Form 116) to the CLIA State Agency (CLIA State Agency Contacts) where the laboratory is located. The cost of a Certificate of Waiver is $180.00 and the facility will be CLIA certified for a period of 2 years. We want to ensure that