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:
- Session 1: Recording Part 1; Recording Part 2; Slides (PDF)
- Session 2: Recording; Slides (PDF)
- Session 3: Recording; Slides (PDF)
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:
- The emergency rule requires reporting by health care providers, health care facilities, local health jurisdictions, and the Department of Agriculture.
- The emergency rule requires animal case reporting of COVID-19 by the Department of Agriculture.
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:
- Electronic Lab Reporting (ELR) – in Production
- ELR submission process -
- ELR reporting meets requirements for laboratories as defined under the Washington Administration Code (WAC) Chapter 246-101 and can be used for reporting all notifiable conditions.
- DOH will be putting out guidance soon on how to report the new data elements required by HHS and the emergency rule.
- Electronic Lab Flat File (ELFF) – being phased out
- ELFF submission process -
- ELFF reporting meets requirements for laboratories as defined under Chapter 246-101 WAC and should only be used for COVID-19 results reporting.
- Many HHS requirements cannot be captured in ELFF.
- We will continue working with labs already in production (or close) for ELFF, but we're moving COVID-19 reporting to the new national flat file.
-
National Flat File (NFF) – In Progress
NFF submission process – The Association of Public Health Laboratories (APHL) collaborated with partners to develop a new National Flat File (NFF) for COVID-19 results. It was based on ELFF and includes the new HHS requirements.
The tool has the ability to generate HL7 messages. If labs submit their data through APHL's AIMS hub, results will be routed to the appropriate states, but the Department will continue to offer SFT or OneHealthPort submissions.
- Electronic Case Reporting (eCR) – Under Development
- Like other electronic reporting, the Department can act as a post office and route electronic reports to local jurisdictions, reducing reporting burden on providers and staff. Health care facilities can report on behalf of their providers as outlined in WAC 246-101-301.
- eCR, once fully in production (provider/facility system and the Department system), meets reporting requirements for providers under WAC Chapter 246-101-101 and can be used for COVID19 case reporting as well as many other notifiable conditions that the platform has programming in place for.
- Provider case reporting requirements:
- The Department is a part of the National Case Reporting Project (eCR Now):
- The Department will be putting out guidance soon on how to report the new data elements required by HHS and the emergency rule.
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.
- Proposed HHS ELR Submission Guidance using HL7 v2 Messages
- COVID-19 Lab Data Reporting Implementation Specifications
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
Resources
- HHS federal COVID-19 reporting requirements
- HHS final implementation guidance (PDF)
- The CDC requires public health departments to daily submit de-identified data to the CDC
- 8/26: CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting