‹ Home
Exported

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
Posted by Nancy Barrett ·

HHS Lab Reporting Aug 7 updates

I notice on the webpage for COVID-19 Laboratory Data reporting, that the update of August 7, 2020 has a what appears to be a change in the Who Must Report section.
 
But antigen testing can be in a patient care setting under a CLIA Certificate of Waiver? 
So now I'm confused. So we have these settings report under our state reporting requirements only? I'm trying to update guidance for labs and want to be sure I understand everything correctly.

Who must report
All COVID-19 testing sites must

  • have a Clinical Laboratory Improvement Amendments (CLIA) certificate,
  • meet all requirements to perform testing, including only using FDA-authorized test systems according to their instructions for use, and
  • report the results of the COVID-19 diagnostic and screening tests that they perform to the appropriate state or local public health department.

COVID-19 testing sites are defined as

  • laboratories that perform clinical diagnostic or screening testing under CLIA,
  • non-laboratory COVID-19 diagnostic or screening testing locations, and
  • other facilities or locations offering COVID-19 point-of-care diagnostic or screening tests, or in-home diagnostic or screening tests.

Comments & Events

Nereida Corral Nereida Corral
Hi all,
Another clarification. Are entities required to report only results for specimens TESTED at their facility? Or for all specimens COLLECTED and/or TESTED at their facility? We are getting a lot of pushback from providers about reporting results for specimens they send to a lab that is already reporting results to us. Providers are overwhelmed with the management of specimen collection, lab submission and results follow up - thus they see their requirement to report something that the lab is already reporting as "duplicate".
Notified 131 people
Mark Dittman Mark Dittman
My interpretation is that state law/reporting regulations dictate this. In PA we require the resulting facility to report via ELR. However, any hospital that we onboard that does outsource one or more specimen types is required to confirm with their contracted lab that they lab is reporting to us via ELR on behalf of the hospital. Otherwise, the specimen collecting facility is required to report to us. We accept the dupes and merge at patient level. We feel it is better to have the duplicates versus missing out entirely. We also take manual data entry directly into our system, which makes it easier for us to gather the send-back results to non-ELR facilities.

Mark
Notified 131 people
Jason Hall Jason Hall
CLIA certificate includes certificates of waiver for those settings. Do we need to be more clear on the website?
Notified 131 people
Nancy Barrett, Epi 4/PH Informatics Specialist Nancy Barrett, Epi 4/PH Informatics Specialist
Yes please. Because anything that makes it clearer for all concerned is a good thing. 
Notified 131 people