In response to the COVID-19 pandemic, the U.S. Department of Health and Human Services (HHS) 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 seventh emergency rule to ensure continued compliance of these federal requirements in alignment with chapter 246-101 WAC, Notifiable Conditions. The Washington State Department of Health (Department) is working with labs, providers, and local health jurisdictions to implement provisions in the emergency rule.
Health Care Providers and Facilities
Health care providers, or health care facilities on behalf of providers, must submit individual case reports of COVID-19 to their local health jurisdiction. Health care providers and facilities must include certain patient demographic and ordering facility data in their laboratory orders and case reports. The table below describes required data components for each reporting entity. The Department is working on a process for electronic case reporting and will announce when it is available.
Entities licensed to conduct waived tests under a certificate of waiver, including point-of-care (POC) testing for COVID-19, must report all positive COVID-19 test results to their local health jurisdiction. This does not include antibody testing. POC testing sites are required to meet the reporting requirements of laboratories for positive cases. The table below describes required data components for each reporting entity. More information on how to report can be found here.
Entities licensed to conduct moderate or high complexity testing must report all positive test results from all nucleic acid amplification tests (NAAT) and antigen tests performed for COVID-19 to their local health jurisdiction. Laboratories must also include certain data when submitting specimens to the Department and when referring specimens to other laboratories. For complete details on what information is required for submission please consult chapter 246-101 WAC, as well as the Department’s provisional reporting notification concerning COVID-19 for additional reporting requests.
Electronic laboratory reporting (ELR) 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.
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. Monthly listening sessions are presented, and recorded, by the ELR team. Emails will be sent out as needed and likely be between one to two emails per month. You may subscribe to the listserv here.
Frequently Asked Questions
- How does the HHS guidance and the emergency rule requirements differ?
The current emergency rule differs from the HHS guidance in two key areas:
- The emergency rule requires entities licensed to conduct moderate and high complexity testing to report positive, negative, and inconclusive results for all NAAT and antigen tests, whereas the HHS guidance requires these results from NAAT only.
- While the HHS guidance applies to laboratories specifically, the emergency rule also requires reporting by health care providers, health care facilities, local health jurisdictions, and the Department of Agriculture in alignment with chapter 246-101 WAC, Notifiable Conditions.
- How do laboratories get the additional patient data to report with test results?
The emergency rule requires health care providers and facilities to include additional required data fields in the lab order submitted to the lab – see Reportable Data Components table.
- What are the electronic reporting options?
For lab reporting, there are two electronic options that allow reporters to fulfill the requirements of the emergency rule: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.
- 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.
- 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.
For case reporting, there is one electronic option under development that will allow reporters to fulfill the requirements of the emergency rule:
- Electronic Case Reporting (eCR) – Under Development
- Like with electronic lab reporting, eCR will allow the Department to act as a post office and route electronic case 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), will allow providers to meet reporting requirements outlined in 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.
Upon notification of successful completion of the ELR, NFF, or eCR onboarding/validation processes (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.
See these links for more information.
- Who can I contact with questions?
- HHS: COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115
- HHS: COVID-19 Lab Data Reporting Implementation Specifications
- State Board of Health: COVID-19 Emergency Rule
- CDC: How to Report COVID-19 Laboratory Data
- 8/26: CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting