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On May 11, 2023, CMS memo QSO-23-15-CLIA was released which provides post-public health emergency (PHE) guidance. The guidance provides clarification for:
- Requirements for reporting of SARS-CoV-2 test results.
- Post-PHE status of enforcement discretions and other flexibilities utilized during the COVID-19 PHE.
Although Washington is a CLIA-exempt state, requirements for medical test sites in Washington must be equal to, or more stringent than, CMS rules and policies. Therefore, the standards described in the memo will be implemented by the Office of Laboratory Quality Assurance (LQA).
Additional Updates for Medical Test Sites in Washington
- The Department of Health (department) has rescinded the emergency rule for medical test sites that mandated reporting of test results intended to detect SARS-CoV-2 or diagnose a possible case of coronavirus disease 2019. The emergency rule was last renewed on January 27, 2023, as WSR 23-04-050. The rescission memo is available here. Medical test sites should refer to WAC 246-101 Part III: Notifiable Conditions – Laboratories and Laboratory Directors for current guidelines for reporting SARS-CoV-2 test results.
- Medical test sites that choose to allow staff to remotely review digital laboratory data, digital results and digital images must follow the guidelines detailed in QSO-23-15-CLIA and must notify LQA@doh.wa.gov of the remote testing site.
For additional questions related to the memo, please contact Laboratory Quality Assurance at LQA@doh.wa.gov.
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