Posted by Kristy Lunquest · Jul 13, 2020 at 6:38 PM

HHS COVID reporting requirements

Hi all,

Excuse my ignorance, as I haven't been able to regularly attend calls. Hospitals have been contacting me asking for updates regarding these HHS reporting requirements and if they need to alter their messages, but I haven't been able to give any direction. Have there been any standardized documents put together to give guidance to labs? or does anyone have any guidance when it comes to where additional data elements go in an HL7 message? Are AOE responses expected to be sent as NTE?

Thanks,
Kristy

Comments & Events

Jason Hall

CDC has updated its website on reporting, https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html. CDC also has a doc for the AOEs in clearance...it’s at HHS right now…that will be added to the website when cleared. In addition, we’ve been doing outreach to professional associations, ACLA, AHA, and others, to let talk about the updated CARES Act guidance and what they’ll be expected to do.

For more technical guidance, you can go to the confluence site, https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages.

Jason

Jul 13, 2020 at 7:15 PM Notified 125 people

Kristy Lunquest

Thank you so much

Jul 13, 2020 at 7:20 PM Notified 125 people

Merylyn Huitz

Good morning, I wanted to follow up from last week's call and to see if there would be any available slides we can use to share with our labs.

Thanks,
Merylyn Huitz
PHI Messaging Manager
Virginia Department of Health, OEpi
Division of Informatics and Information Systems (DIIS)
109 Governor St
Richmond, VA 23219
Office: 804-864-7941

Jul 14, 2020 at 1:12 PM Notified 125 people

Jason Hall

We’re finishing clearance on talking points that states may use. Sorry it’s not out yet.

Jason

Jul 14, 2020 at 3:09 PM Notified 125 people

John Satre, Informatician

Hi Jason,

Is there an ETA on the finalized technical guidance for implementing the additional CARES Act data elements or can we consider the guidance on the https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages in final form so that we can move forward and finalize our development and share these details with our reporting parnters?

Thanks.

Jul 16, 2020 at 5:41 PM Notified 126 people

Jason Hall

The AOE’s should be cleared by tomorrow for us to post. I think you should share the details on the confluence site until everything gets posted on our reporting website.

Jason

Jul 17, 2020 at 1:29 AM Notified 127 people

Jenizah Melendez Jenkins

Hi Jason,

I have shared the COVID reporting website and the confluence page with our ELR partners. However, concern over meeting the August 1st deadline was expressed. Please advise.

Thanks,
Jenizah

Jul 17, 2020 at 7:21 PM Notified 127 people

Kristy Lunquest

Hi, will guidance be posted this week? Facilities are getting really antsy.

👍

Jul 20, 2020 at 6:28 PM Notified 127 people

Merylyn Huitz

Good morning,
Adding on to Kristy Lunquest's question, is the deadline still 8/1 for the new HHS COVID reporting requirements?

Jul 27, 2020 at 1:27 PM Notified 128 people

Jason Hall

As of right now, it’s still 8/1

Jul 27, 2020 at 2:28 PM Notified 128 people

Sita Smith

Being completely pragmatic, I have indicated to providers what MA DPH needs to do in order to accept the new variables, and approximately how long that will take us - which them gives them some sense of of long they have to get their EMR systems aligned.

Jul 27, 2020 at 2:44 PM Notified 128 people

Logan Smith

Hi Jason,

What is the penalty for PHAs or facilities are if labs aren't able to comply with the 8/1 deadline? There is a huge variation in capacity in the labs we are working with. There is concern that the deadline may be unrealistic for many of the facilities.

Jul 27, 2020 at 3:23 PM Notified 128 people

Mark Dittman

For Question 2:
No LOINC is given
This should be a Yes, No, Unknown and if Yes, then the symptom code
is this meant to be repeating or are labs expected to have one OBX per symptom? We assume repeating in OBX-5 as defined/not defined

Question 7:
How is it to be sent?
If the answer to #6 is “No”, how will the test value set and result value set and test performed date be sent. Provide an example, as was originally requested to be contained in these specs.

Jul 27, 2020 at 3:37 PM Notified 128 people

Jason Hall

We all understand most, if not all, facilities won’t be ready to fully comply by August 1. At this time we don’t know of any penalties that will be levied against testing entities by HHS/CMS/FDA. It is possible an enforcement policy will be produced soon, but nothing final yet.

Jason

Jul 27, 2020 at 4:41 PM Notified 128 people

Steve Barber, eCR Coordinator

The CDC site, “How to Report COVID-19 Laboratory Data” was updated on 7/25/2020. The AOE’s that could be answered with the value set of Y/N/UNK have been revised and now have SNOMED-CT values for expected answers, if the question could be answered “yes”. The Confluence website only shows an update for the LOINC that is to be used for the “Date and time of symptom onset” question. Also, there is a new question on the CDC site - #7 [If No for question #6] What type of test was the most recent prior test, what was the result, and what date was the test performed? There are possible answers listed, but no guidance in coding for either the questions, or the answers. What are the expectations for messaging, since we are so close to the 8/1/2020 deadline?

Jul 27, 2020 at 7:30 PM Notified 128 people

Nancy Barrett, Epi 4/PH Informatics Specialist

Hi all,
Jason welcome back for what that is worth. :-)

Mark - being able to repeat the OBX-5 component is not part of the ELR R1 guidance; I believe that is going to ballot in September. It would require some changes. That is what I glean from one of the HL7 workgroup emails I'm on.

Steve and others -- there was intense discussion last week to ask HHS to hold to the June 4 guidelines (y/n/u) for this August 1st, but we see that there is STILL "scope creep". Myself and others have brought this up and argued that we need to have clear guidance on just the June 4 requirements and get that going and stable, before we start adding additional expectations for answers that should come to PHAs on provider case reports.

It's more than frustrating that what is published is ahead of guidance for labs and PHAs, who have to make this happen. I can say with nearly 100% certainty that we won't be ready to implement by August 1st, let alone process AOE info from messages.

I would like to see more coordination and specific information on what labs/aggregators are doing, especially for labs that send info to more than one jurisdiction. Also, how are hospital LIS vendors helping hospitals? I've heard that it may not be that much. There is not enough specific communication going to those who have to make this happen.

I can tell you that CSTE has a small working group actively working with APHL and CDC to get information together in a few convenient places to share.

Jul 27, 2020 at 7:45 PM Notified 128 people

John Satre, Informatician

The 2 sites appear to be out of synch; which are we supposed to follow?

https://confluence.hl7.org/pages/viewpage.action?pageId=86967947#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-Introduction

https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html

Some of the differences are not minor. For example:
Symptomatic as defined by CDC? (confluence)
Y/N/Unk on confluence page
Do you currently have one or more of the following symptoms? (CDC)
SNOMED code for specific symptoms in what appears to be a repeating field

Jul 28, 2020 at 12:57 PM Notified 129 people

Riki Merrick, Terminologist at APHL

Hi JOhn,
yes the sites are out of sync - my apologies - we are working to sort out the NEWLY ADDED requirements - those require different LOINC codes, which you can see, where not provided on the CDC site.
However I can try to find time to update the HHS guidance site with the additional elements highlighting where the questions are we are working on, if you think that would help.

Riki

Jul 28, 2020 at 1:04 PM Notified 130 people

Merylyn Huitz

Riki,
It would be helpful to update the confluence page to address the changes on the CDC website. Labs are asking us how to approach this and we are unable to provide the appropriate guidance at this moment. Will the flat file specifications also be updated to account for these changes (including the new question added)?

Thanks!
Merylyn

Jul 28, 2020 at 1:20 PM Notified 130 people

Riki Merrick, Terminologist at APHL

Because the flat file was designed for ANY disease, not just COVID-19 and I had some examples from states,it already captured some of those additional elements as optional - except the prior test information - so that is something to discuss.

Originally I had envisioned the layout of this file to be 1 row per observation, including AOEs, so that it would be ever flexible, but we decided that AOEs should be columns, so now we need to update the file format, when new AOEs need to be added (we need to also define the governance around how we decide to make changes to that flat file format going forward).

Thanks for the feedback, I will try to update the confluence page by EOD today.

Riki

Jul 28, 2020 at 1:39 PM Notified 130 people

Michelle Barber

I'm getting questions about whether or not the AOEs are required for both antigen and antibody testing (and the assumption that the answer is not for antibody testing). But... it looks like both from the FAQs: ..."CARES Act and the implementing guidance require..." Advice?

Thx, mb

Jul 28, 2020 at 1:55 PM Notified 130 people

John Satre, Informatician

Can we schedule a webinar to straighten out all of the confusion. At this point I'm not sure it matters what the final details are, but we have to have some final guidance that is stable.

👍

Jul 28, 2020 at 2:19 PM Notified 130 people

Brooke Beaulieu, Surveillance/Informatics Program Analyst

We do have an upcoming ELR workgroup call on 8/4, but also acknowledge that calls occurs after the 8/1 implementation date.

What is the feeling on convening an adhoc workgroup call this week? If in favor, please "thumbs up" this comment and we can work to get something scheduled (most likely on Thursday 7/30).

Best,

Brooke

👍

Jul 28, 2020 at 4:27 PM Notified 131 people

Riki Merrick, Terminologist at APHL

Thumbs up

Jul 28, 2020 at 5:30 PM Notified 130 people

Sita Smith

Thumbs up

Jul 28, 2020 at 7:47 PM Notified 130 people

David DiCesare

Thumbs Up!

Thanks and Stay Safe,

David DiCesare
NYS ELR Coordinator
ECLRS Help Desk
Bureau of Surveillance and Data Systems
Local – 518-402-5943
Long Distance – 866-325-7743
David.dicesare@health.ny.gov

Jul 28, 2020 at 11:57 PM Notified 128 people

Merylyn Huitz

Good morning,
I wanted to check in and see if there are any recent updates since our call yesterday.

Thanks!

Jul 31, 2020 at 2:35 PM Notified 128 people

Jason Hall

We’re almost there. We have language consistent with what we covered on the call yesterday and are awaiting final approval. HHS has cleared their guidance but is hasn’t posted yet. We’re hoping to get the “reasonable” message out very soon and will let states know so they can use it too.

Jason

Jul 31, 2020 at 2:39 PM Notified 128 people

Merylyn Huitz

Thank you for the update, Jason!

Jul 31, 2020 at 2:40 PM Notified 128 people