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CSTE National ELR Workgroup

Welcome to the CSTE National ELR Workgroup Basecamp! We hope you will utilize the space to share resources with colleagues, start discussion threads, and identify topics for the workgroup to tackle on future calls. All workgroup members will have the opportunity to join. Please note that you may edit your notification preferences to suit your needs (and your email inbox). If you are not already on the ELR distribution list and would like to receive call communications, please enroll using this subscription form (copy and paste in browser): https://app.smartsheet.com/b/form/5a91a4579952496682084796b82112e6
Becky Lampkins, Manager, Surveillance/Informatics Program at CSTEMegan Toe, CSTEScott Troppy, Surveillance Epidemiologist at MA DPHMeredith Lichtenstein, CSTEAmy Drake, NMJohn RobertsNancy Barrett, Epi 4/PH Informatics SpecialistErin Holt, TDHRita Altamore, EpidemiologistDavid DiCesareJason HallWalter Kemper, ELR Coordinator, NC DHHS Div of Public HealthJulie LuepkeCarmen Pugh, Labcorp Manager State Reporting at LabCorpTom Safranek +399 others
Other ELR by Corinne Davis ·

📈 Ochsner Health COVID Clinical Trial Reporting

The APHL AIMS ELR Implementation Team is working to onboard Ochsner Health for COVID ELR reporting via AIMS. Ochsner is working with Pfizer on a clinical trial where they will be testing participants for COVID twice during the duration of the trial. The sample collection will be at home, but testing will be conducted by a lab (Covance). A couple of questions (below) were brought up on what needs to be reported since this is for a clinical trial (patient demographics will be reported in the ELR). The impacted states are Louisiana (mainly), Mississippi, Tennessee, Georgia, Arkansas, Florida, and Texas, but it is possible there will be some participants from other states. Can you please provide your feedback on the questions below? We will also bring this up on the centralized ELR call this Thursday.

  1. Ochsner is conducting testing using a COVID/Flu/RSV multiplex panel (under EUA approval now). They were under the impression that they only needed to report the COVID portion. Can they only report COVID even if the order (OBR-4) indicates a panel was conducted? 
  2. Per CDC, clinical trials only need to report positive results (available here: https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html). However, it also states that they should follow the local/state reporting requirements which may differ. Should we instruct Ochsner to report all COVID results or just positive results?
Thanks,

Corinne Davis

APHL AIMS ELR Implementation Team

Comments & Events

Tania Bechtel Tania Bechtel
Hi Corinne- Louisiana currently gets an ELR feed from Ochsner.  Will only the clinical trial results come through the AIMS feed? Will the demographics come though the AIMS feed as well, or our regular feed?
We want all results (positive and negative) for the COVID portion.  RSV is also reportable.  We can take the full panel if needed.
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Corinne Davis, HL7 Implementation SME Corinne Davis, HL7 Implementation SME
Tania Bechtel Tania - Only the clinical trial results will come through the AIMS feed is our understanding, but we will follow up with them just to confirm. The full demographics will come through via AIMS. Thank you for confirming that you would like to see the results from the panel and for them to report all results (pos/neg/indeterminate). 
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Emily Roberts Emily Roberts
Utah would like ALL COVID results from the clinical trial and positive Influenza and positive RSV, if a panel is run.

Thanks- Emily Roberts
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Theresa Kittle, Epidemiologist/ELR Coordinator Theresa Kittle, Epidemiologist/ELR Coordinator
Hi, Corrine,

For Mississippi, we only want the COVID portion of the panel reported to MSDH. And MS does want all COVID results sent to MSDH, not just the positive ones.

Thanks,

Theresa

Theresa S. Kittle, MPH
Epidemiology Program Director
Mississippi State Department of Health
www.HealthyMS.com<http://www.healthyms.com/>
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Corinne Davis, HL7 Implementation SME Corinne Davis, HL7 Implementation SME
Tania Bechtel Tania the results you receive in LA is most likely from Ochsner Health. The clinical trial will actually be sent from Ochsner Academics. So your current feed with Ochsner Health will not be affected. The MSH-4 value will be an APHL generated CLIA since Ochsner Academics will not have a CLIA.

Theresa Kittle, Epidemiologist/ELR Coordinator Theresa  since LA and Utah need the panel results, we are not able to instruct Ochsner to only send COVID. APHL is working on a multiplex solution in the future to filter out results in a panel based on public health reporting rules. That solution is still a few months out though. Once we get closer to end to end testing with Ochsner we will get a better idea of the volume for MS so you can determine how that will impact your state.
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Theresa Kittle, Epidemiologist/ELR Coordinator Theresa Kittle, Epidemiologist/ELR Coordinator
Corinne Davis, HL7 Implementation SME Corinne - I understand. MS will filter out the RSV and Flu results once the ELR messages are received until the APHL solution is in place.
Thanks - Theresa 
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