Guidance for Electronic Submission of COVID-19 Testing Results

Ohio Public Health Rule

Persons in charge of any laboratory that examines specimens of human origin for evidence of COVID-19 infection shall electronically report within twenty-four (24) hours the results of all such examination, in the manner set forth by the Director and according to the protocols outlined for COVID-19 reporting on the Ohio Department of Health (ODH) Electronic Laboratory Reporting website and the updated U.S. Department of Health and Human Services (HHS) Laboratory Data Reporting Guidance. 

• COVID-19 testing facilities are no longer required to report negative results for tests authorized for use under a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver through The Centers for Medicare & Medicaid Services (CMS). This includes rapid and antigen testing performed for screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and rapid testing performed in pharmacies, medical provider offices, and drive-thru and pop-up testing sites.
• COVID-19 testing facilities are still required to report all results including, but not limited to, positive, negative, invalid, and inconclusive for laboratory-based nucleic acid amplification tests (NAATs) that are performed in a facility that is certified under CLIA to perform moderate- or high-complexity tests.
• In addition, COVID-19 testing facilities are no longer required to report any antibody test results. 

Laboratory results should be electronically reported according to the protocols outlined below. 

The Director’s Journal Entry summarizes reporting requirements for COVID-19.

Laboratory or Facility Registration

Any entity performing any type of COVID-19 testing of human origin must register the name of the laboratory or facility at http://coronavirus.ohio.gov/registerlab and follow procedures below to request access to the authenticated web portal or to the ODH SFTP server.

Establishing Secure Connection to ODH and File Validation

ODH offers two connection methods for the submission of COVID-19 testing results, including a secure, authenticated web portal electronic laboratory reporting (ELR) file upload tool and secure file transfer protocol (SFTP).

1. Authenticated Web Portal

• An authenticated web portal was built for any entity (e.g. long-term care facility, private and hospital laboratories) performing laboratory testing, specifically for COVID-19, to securely and safely transmit electronic files containing protected health information, using Ohio’s custom CSV template.
• Any person representing a testing facility may create a user account at https://ohid.ohio.gov and request access to the ELR File Upload application to securely submit electronic laboratory reporting (ELR) files.
  • Step-by-step instructions for account creation can be accessed through OH|ID.
  • After account creation, the user must request access to the application ELR File Upload. Step-by-step instructions on this process can be accessed through OH|ID.
    • Click on APP STORE and type “ELR File Upload” into the search bar.
    • Scroll down the page and select the “ELR File Upload” tile.
    • Click on “Request Access To Group,” check “Agree to Terms” box, and click “Request Access to Group.”
    • Application requests are reviewed and approved by ODH personnel who will provide additional details on file submissions. Applicants will be assigned to a reviewer who will verify the file structure and complete a brief file validation.

2. SFTP Connection

• SFTP connection is generally reserved for larger volume laboratories and hospitals capable of setting up an automated HL7 ELR interface. This process involves whitelisting of lab server IP accounts, and the submitting entity must provide a static, external IP address. If interested, please request the SFTP request form by sending an e-mail to ELR@odh.ohio.gov.
• Upon successful, secure connection to ODH’s SFTP server, ODH personnel will verify the file structure and complete a brief file validation.

Line Level Reporting Instructions

• Each entity must electronically report ALL COVID-19 testing performed at your facility according to the protocols outlined in the Ohio Public Health Rule section above and the updated U.S. Department of Health and Human Services (HHS) Laboratory Data Reporting Guidance.
• The onboarding process will take several weeks to complete. Positive laboratory findings for ALL COVID-19 testing must be reported to the local health department (LHD) where the patient resides until ODH successfully completes the file validation for your laboratory or facility to submit electronically. This may be completed by faxing the confidential case report form or the Human Infection with 2019 Novel Coronavirus Case Report Form to the LHD. To identify the LHD where the patient resides, you may use the LHD address tool. If the patient resides out of state, you must report those results to the appropriate state health department where that person resides.
  • Facilities certified under CLIA to perform moderate- or high-complexity nucleic-acid amplification tests (NAATs) should NOT report negative COVID-19 test results to the LHD; however, the reporting entity must maintain and prepare to send ODH an electronic file of all negative COVID-19 testing results, as of October 20, 2020. This file must be reported to ODH using the selected electronic submission method once ODH personnel completes the file validation for your facility.

Alternate Line Level Reporting Options

• Several alternative methods exist for laboratories or other entities performing COVID-19 testing to electronically report their testing results.
  • CMS-certified long-term care facilities may submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC’s National Healthcare Safety Network (NHSN).
  • All entities may onboard with CDC and U.S. Digital Service’s application, SimpleReport. Watch video about SimpleReport for more information. The service is free but does involve a brief onboarding process with CDC personnel. If interested, sign up to get started.

Technical Specifications

• CSV Technical Specifications and Formatting Guide for Long-Term Care Facilities
• CSV Technical Specifications and Formatting Guide for Laboratories
• Blank CSV File Template for all Reporting Entities
• HL7 Technical Specifications

Trainings and Recordings

Ohio Department of Health Discussion with Long-Term Care Facilities in Partnership with the Ohio Health Care Association and Leading Age Ohio on COVID-19 Reporting Requirements.  This training was held on Sept. 21, 2020, and included a presentation on COVID-19 reporting requirements for Ohio. 

Slides    Recording

Ohio Department of Health Demo with Laboratories on Web Portal Feature Enhancements for COVID-19 Aggregate Count Submissions. This training was held on Oct. 14, 2020, and included a demo on web portal enhancements for COVID-19 testing aggregate count submissions.

Recording

Ohio Department of Health Discussion with Laboratories on COVID-19 Electronic Submission Requirements.  This training was held on Oct. 16, 2020. and included a demo on using the Authenticated Web Portal for submitting line level COVID-19 testing results to ODH. 

Recording

Ohio Department of Health Discussion with Higher Education Institutions in Partnership with Ohio Department of Insurance and Ohio Department of Higher Education on COVID-19 Reporting Requirements and Electronic Submission Process.  This training was held on Nov. 4, 2020, and included a presentation on COVID-19 reporting requirements and a demo on using the Authenticated Web Portal for submitting line level COVID-19 testing results to ODH. 

Slides    Recording

Ohio Department of Health Discussion with Residential Care Facilities – Assisted Living in Partnership With the Ohio Assisted Living Association (OALA) on COVID-19 Reporting Requirements and Electronic Submission Process.  This training was held on Nov. 13, 2020, and included a presentation on COVID-19 reporting requirements and a demo on using the Authenticated Web Portal for submitting line level COVID-19 testing results to ODH. 

Slides    Recording