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Document Covid-19 Lab Reporting Change Proposal.docx (15.9 KB)

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Hi - per discussions at CSTE, Bryant Karras has said he would support bringing up the request to leadership to stop having to collect negative results and AOE. I've drafted this statement for input and comments. Also proposed that states could go to a reporting method similar to that in place for influenza. 

Comments & Events

Nancy B. posted this on · Download ↓
Lesliann Helmus
Nancy – I believe there was a push to improve the demographic information (including race and ethnicity) and contact information in the lab reports at the same time that the AOE questions were added. Would it be important to indicate that the improvements made in the completeness of this information were essential to the response and will continue to be important to understanding and responding to COVID-19? We wouldn’t want people to assume that they can discontinued sending complete demographic and contact information if the AOE questions were discontinued.

Lesliann Helmus, MS, CHTS-CP (she, her, hers) (What’s This?<http://www.mypronouns.org/)>
Associate Director for Surveillance
Division of Health Informatics and Surveillance
Center for Surveillance, Epidemiology and Laboratory Services (CSELS)
Deputy Director for Public Health Science and Surveillance (DDPHSS)

Centers for Disease Control and Prevention (CDC)
MS V25-3
1600 Clifton Rd, NE, Atlanta GA 30329-4027
Email lhelmus@cdc.gov<mailto:lhelmus@cdc.gov> | Phone 404-498-0167 | Fax 404-498-6235

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Nancy Barrett, Epi 4/PH Informatics Specialist
Hi Leslieann,
Good point. This is no way intended to send the message to laboratories or other testing locations to not report required or RE data elements for patient demographics - especially as I'm sure many states require that information to be included in lab reports under their state reporting requirements.

This is to take a good look at the extra requirements added for covid-19 test result reporting and stop requiring those that no longer (or may not even have) added public health value vs. the burden on states and reporters.

Thank you!
Mark Dittman
But the AOEs had nothing to do with Race/Ethnicity, which were added as 'required' as separate parts of the HHS guidance, correct? I think we all struggle with getting full demographics but the point has always been the totally misguided AOE content which is not lab-side data. Reference and pop-up labs struggle with the basics and adding AOE is just not feasible for the majority of the them. The EHR-based lab systems from hospitals are another discussion and by and large, for PA, were weeks to months of having those systems get things right. The AOE implementation has been a burden and caused more headaches than benefit, in my opinion, based on the issues they have caused from day 1. In PA we simply could not implement systemic changes to consume the AOEs line by line so we turn them all into 'Notes' which are appended to each report. Generally, what we get, if we get it, is more junk than useful.

Bottom line, demographic data never should have been nor should be contrived to equate to the AOE questions. This was a train wreck looking for a place to happen from inception and far too little thought and feedback was gathered from real-world staff on what impacts would be put on the states.
Sita Smith
MA implemented the systemic change to consume AOE elements, and we have perhaps 20% of our routine providers who have configured their LIMS to send it, but we are pretty much getting "Unknown". Nobody is asking these questions, or if they are, they are not being answered in a way that can be configured in the HL7 message. In my view, they add no value -  I am confident that out Epis do not look at them, and we do not report out on them.
Device identifier is slightly more complete, but we are not using this field either, it goes into Maven but has been made invisible because we were getting such variation in content and it was confusing users.
Riki Merrick, Terminologist at APHL
I agree with the issue about complete demographic data is separate from the AOEs. 
There was input from the EPI side (and when we were working on this guidance under a time crunch several EPIs contributed, indicating that at least some of these AOEs were important to prioritize contact tracing (employed in healthcare), while several of the others are to assess severity (which could also be done later during investigation, but the federal agencies wanted to know as soon as possible).
The device identifier is important for FDA - especially since these are all under EUA, so getting "post-market" data about performance is important. may not be useful for PHAs, but may also help labs compare results and is very important to patient care, when trending is used (in order to be sure you have truely equivalent results).
Just my $0.02 for background.
Sita Smith
Truth, Riki. 
I appreciate that AOEs were thought important at the time, but our experience is that they are just not providing much added value, in practice.
Re device identifier -  also agree, we are not using it, but we are definitely collecting it for if/when it becomes useful.
Riki Merrick, Terminologist at APHL
And re-assessing usefulness is also important - I wholeheartedly support that!
Nancy Barrett, Epi 4/PH Informatics Specialist
Hi - we accept but do not use AOE info either and mostly it is unknown or blank. We have these variables to be answered from case reports and did not want to add a separate set just for these or overwrite provider provided data. I think we can capture some sort of device identifier - but in csv files it is not the full conformant description as in HL7. 

The more important issue is now that we have some experience can stop flailing around to collect any data from anywhere and focus on what is really useful and usable. I think we end up with collecting data or having the labs collect data because PHAs do not have efficient or timely methods of getting the case report data - which is a different topic.
Annie Fine
Wearing CSTE hat now but commenting based on NYC experience. AOE data was pretty near useless and only clogged up the system more. Would advise discontinuing.

Re. negative results though - I think this is a different story. Maybe not all jurisdictions want them but some will. And knowing how many tests are being done and WHO is being tested is sometimes very important for interpreting numerator data. This may not be true for all diseases but I would like to get more of a sense of how many health depts might still want negative reporting, at least from traditional labs that can report via automated file-based electronic mechanisms (non-manual).

Curious re. thoughts on this
Jennifer Stewart
Unfortunately NC has made negatives reportable, but we would have more momentum to go back and ask to have that rescinded if national guidance would come out against. 
Cody McNeese
Hi,

Do we have any updates on the proposed reporting rules? Specifically, around reporting of AOE's? Jason Hall Jason  

Thank you,
Cody
Jason Hall
The updates still haven't made it through the process. The updated guidance, as proposed, removes the AOE data elements language... they're not referred to. The technical implementation documentation still has them, for those that collect them and want to send them. AOEs remain optional.


Jason
Cody McNeese
Hi Jason,

To clarify, are the AOE’s currently optional? Or is this a circumstance once HHS updates language, if they update it?

Thank you,

Cody Elizabeth McNeese, MPH
Electronic Laboratory Reporting Coordinator
OREGON HEALTH AUTHORITY
Public Health Division
Acute & Communicable Disease Prevention (ACDP)
Cell: 971-420-5154
Email: Cody.E.McNeese@dhsoha.state.or.us<mailto:Cody.E.McNeese@dhsoha.state.or.us>
http://www.oregon.gov/OHA
Jason Hall
They are not currently required under the existing guidance. They are "requested"...read optional. This won't change with the proposed updates.


Jason