Washington State Medical Test Site Certificate of Waiver requirements, and SARS-CoV-2 (COVID-19) testing and test result reporting guidance

Washington State Medical Test Site Certificate of Waiver requirements, and SARS-CoV-2 (COVID-19) testing and test result reporting guidance

The Washington State Medical Test Site Program issued the following guidance document to help facilities in Washington understand the regulatory requirements for performing testing authorized for use under a certificate of waiver and provide guidance for maintaining compliance with the state Washington State Medical Test Site SARS-CoV-2 (COVID-19) test result reporting rules.

Washington State Medical Test Site Certificate of Waiver requirements, and SARS-CoV-2 (COVID-19) testing and test result reporting guidance document

On August 26, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum regarding new reporting requirements for laboratories performing SARS-COV-2 (COVID-19) testing. These new reporting requirements were posted to the federal register on September 2, 2020. Changes to federal Clinical Laboratory Improvement Amendments (CLIA) rules are to include new requirements for on-site reviews of certificate of waiver and provider performed microscopy licenses to verify compliance with the new and existing rules. Additionally, on January 8, 2021 CMS issued QSO memo 21-10-CLIA regarding the requirements for reporting SARS-CoV-2 test results.