Reporting COVID-19 Test Results

In response to the COVID-19 pandemic, the U.S. Department of Health and Human Services issued reporting requirements for laboratories to ensure complete demographic data reporting with COVID-19 test results. The Washington State Board of Health (Board) recently adopted a third emergency rule to ensure continued compliance of these federal requirements. The Washington State Department of Health (Department) is working with labs, providers, and local public health departments to implement the emergency rule.

Point-of-Care Testing

Facilities administering point-of-care (POC) testing for COVID-19 must report all their COVID-19 testing results to the Washington State Department of Health. See this link for more information on how to report.

Labs

Electronic reporting to the Department meets local, state, and federal lab reporting requirements for COVID-19 results. Once electronic reporting to the Department is in place, labs do not need to send additional reports to local health jurisdictions (LHJs) or the Centers for Disease Control and Prevention (CDC). The Department has a process to work with and approve labs for submitting their results electronically and satisfying their disease reporting requirements. Labs cannot make that determination on their own. Contact ELR@doh.wa.gov if you're interested in this time-saving measure.

The ELR team has hosted several listening sessions on the HHS/Board requirements. Recordings and presentation slides for these listening sessions can be found here:

Additionally, the ELR team has created a listserv to provide general information related to WA-specific electronic laboratory reporting, national updates, frequently asked questions and future listening sessions. Emails will be sent out as needed and likely be between one to two emails per week max. You may subscribe to the listserv here.

Healthcare Workers

In addition to laboratory reporting covered above, health care workers or health care facilities on behalf of their workers must report cases of COVID-19 to their LHJ. The Department is working on a similar process for electronic case reporting and will announce when it is available.

Also, under the emergency rule, health care workers must submit additional information as part of a lab order to ensure that the lab has all the data required to submit to public health.

Frequently Asked Questions

What must be reported by whom?

Washington State (under WAC 246-101) requires laboratories to report all COVID-19 results (including positive, negative, inconclusive; and other results based on State Health Officer Letters) to the LHJ of the patient's residence. The Board's second emergency rule (WAC 246-101-017) requires additional data elements that must be reported, including complete demographic data aligned with new federal requirements from the U.S. Department of Health & Human Services.

How do the HHS/CDC and the emergency rule requirements differ?

The current emergency rule aligns fully with HHS/CDC requirements and technical specifications except for the following:

How do labs get the additional data to report to DOH?

The emergency rule requires healthcare workers ensure the additional required data fields are part of the lab order and submitted to the lab.

What are the electronic reporting options?

There are two electronic options for reporting results to the Department in production and one under development:

Upon notification of successful completion of the ELR, ELFF, or eCR onboarding process (contingent on the Department being able to route the data into our surveillance system), laboratories or providers in the case of eCR, no longer need to send COVID-19 results to the LHJs.

How do I meet the new HHS lab requirements?

The Federal CARES Act Section 18115 created lab reporting requirements for COVID-19. Guidance from the CDC describes how to meet the new requirements. See full details.

The CDC requires public health departments to submit de-identified data to the CDC on a daily basis, which the Department does already. This allows labs to meet their federal reporting requirements by sending lab results to their state/local public health department. The goal is to reduce the burden of reporting to multiple entities.

To ensure we can help labs meet all of their federal reporting requirements, the Department is working to update our systems to ensure all required fields can be sent to the Department and to update our disease reporting systems to ensure the Department can send the additional data fields on to the CDC as part of our current daily submission.

The federal deadline for reporting to the CDC was set as August 1, 2020. the Department will be contacting labs as soon as our disease reporting systems are modified to add these additional data fields to what is submitted to the Department via ELR. NFF includes the HHS requirements. For labs who plan on sending the Ask on Order Entry (AOE) questions for COVID, follow this guidance for WA State (PDF).

See these links for more information.

I have questions about the new CMS requirements?

On August 26, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum (PDF) regarding new reporting requirements for laboratories performing COVID-19 testing. These new reporting requirements were posted to the federal register on September 2, 2020. Changes to federal CLIA rules are to include new requirements for on-site reviews of certificate of wavier and provider performed microscopy licenses to verify compliance with the new rules. Additionally, CMS is requiring new civil money penalties, which will be $1000 for the first day of noncompliance, and $500 for each subsequent day the laboratory fails to report COVID-19 test results. These changes are expected to be completed by mid-October. If you have any additional questions regarding compliance or penalties, email lqa@doh.wa.gov.

For questions about NFF, ELFF, or ELR please contact ELR@doh.wa.gov and for questions about eCR please contact eCR@doh.wa.gov

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