Many long-term care facilities (LTCFs) have received or will receive COVID-19 antigen point of care (POC) testing machines and supplies from the federal government to help facilitate timely testing of residents and facility staff. Through the distribution of the machines, LTCFs will act as the diagnosing provider and now the laboratory for the tests which requires reporting of all test results to the Missouri Department of Health and Senior Services (DHSS).
Properly submitting all test results (positive, negative, and other results) in a timely manner is important to the health and safety of the community. To expedite the reporting process, DHSS is requiring all facilities to submit test results in an electronic format with the ultimate goal of onboarding all LTCFs to electronic reporting within the next 30 days.
DHSS has assembled a team to assist you in this effort. Ryan Marsch and the DHSS Onboarding Team (ELR@health.mo.gov) will be your primary contacts as you onboard for electronic reporting of test results. Tracy Niekamp (tracy.niekamp@health.mo.gov) and Shelly Williamson (shelly.williamson@health.mo.gov) at the Division of Regulation and Licensure are also available to assist you with any questions.
Documentation and Reporting of Point of Care Test (POC) Results
By administering the POC tests, a LTCF is acting as a laboratory which is required to submit all COVID-19 test results (positive, negative, other) to DHSS for testing performed in their facility. The facility is also acting as the provider, and are required to submit case reports to DHSS.
Facilities, including K-12 schools, long-term care, and higher education institutions which administer POC tests may report all the necessary information for both the laboratory report and the case report on a single comma separated values file (CSV), which is a format-free version of a spreadsheet. A template will be provided to the facility by DHSS. Required data fields include facility information, patient demographics, lab results and basic information about symptoms.
The CSV file is then uploaded to a Secure File Transfer Protocol (SFTP) site, and is auto-ingested into the state’s disease monitoring platform, known as EpiTrax. This information is then immediately accessible to local and state health authorities.
For long-term care facilities, this means that they no longer need to complete an online CD-1 form for tests that they perform on-site, acting as a laboratory. Long-term care facilities must continue to submit an online CD-1 form to report positive COVID-19 cases that occur in their facilities if the test was performed by an external laboratory.
To successfully submit test results through SFTP, testing sites will need:
- Reporting template from DHSS
- Access to a computer/laptop with Microsoft Excel or an alternative application that can work with Excel files
- Access to the Internet
- User name and password for the secure upload site
There are three steps to onboarding to laboratory/case reporting:
Step 1: Starting Wednesday, October 7, DHSS will contact long-term care facilities in onboarding groups. Look out for an invitation email with the following resources:
- A link to a brief survey for collecting contact information on the team member assigned to submit the data in your facility. Note: Once you receive this email, please complete this survey within 24 hours. If possible, we ask that you complete this survey in advance of the invitation email at this link: https://stateofmissouri.wufoo.com/forms/ma3vqye0hqzxkj/
- This will help our team expedite this process and get you up and running as soon as possible.
You may also find a link to this survey and additional information here: https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/how-to-report-lab-results.php - A CSV Excel file to facilitate seamless reporting into EpiTrax, DHSS’ disease surveillance system
- Electronic COVID-19 Laboratory Reporting Submission Instructions to walk through submitting files via SFTP
- A second email with your SFTP credentials
Step 2: You will start to submit files via SFTP. To expedite this process, your first submission may consist of test data, as it will be for validation purposes only. DHSS will review the data for accuracy and reach out if any changes are necessary.
Step 3: Once your data is validated, you will go live for ongoing submissions. Properly formatted data ingests into EpiTrax where DHSS and local public health agencies document and track case investigation activities.
If you have questions about formatting your Excel files or how the process works, please contact ELR@health.mo.gov. There are over 1,000 facilities that may receive some type of point of care test, so be aware that there may be some delay in the onboarding process.
If you have already begun testing at your facility and need guidance for reporting while you work through the onboarding process, please contact ELR@health.mo.gov for assistance.
CLIA Requirements
Any site that performs laboratory testing must follow applicable regulatory requirements including federal, state and local mandates for testing, as well as requirements for the safety and confidentiality of personal information. Use of this authorized test is limited to Clinical Laboratory Improvement Amendment (CLIA) certified laboratories that meet the requirements to perform moderate, high or waived complexity tests and Point of Care (POC) settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. If your site does not have a CLIA Certificate of Waiver or for more information about CLIA requirements, please contact the CLIA Program at DHSS by email CLIA@health.mo.gov or by telephone at 573-751-6318.