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How to send SOGI data in Lab orders (and probalby results, too) to accommodate state legislation

In preparation for our Open ELR call this week (Thursday 3/24/2022 4 - 5 PM EDT):

On the HL7 Lab call on Friday (https://confluence.hl7.org/display/OO/2022-03-18+LAB) we discussed how to send SOGI data in Lab order messages and came up with a few options: https://confluence.hl7.org/pages/viewpage.action?pageId=104570923#SexualOrientation,GenderIdentity,AdministrativeSex,BirthSexetc-OptionsforOMLmessages

That same page shows the discussions we had when CA rquired them to be included in ELR for COVID-19 above (we landed on sending them as AOEs with the OBR for the test they belong to). There is a lot of work going on at HL7 under the Gender Harmony Project (https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project) - they are trying to ensure that this data is properly represented in ANY of the HL7 product families, including v2 (lab messags) CDA (eCR) and FHIR (eCR and future connections for lots of use cases); the current proposal for v2 is linked from the lab call minutes page, but also here for ease (https://confluence.hl7.org/download/attachments/76152954/SOGI%20proposal%20updated%2020211212.docx?api=v2).

The goal is to have ONE WAY for all PHAs SOGI data requirements and at the same time minimize any re-work that has to happen, if legislation is effective BEFORE the final solution has been fully vetted through HL7 ballot and publication (like in NJ).

Please review and come with your thoughts and feedback.

Talk to you all Thursday at 4PM ET!

Comments & Events

Riki Merrick, Terminologist at APHL
I forgot to give you the call info - in case you don't already have it:
Conference Line Details
 
Topic: ELR Open Call 
Thursdays: 4:00 pm - 5:00 pm EST
 
Meeting ID: 940 4241 0458
Dial: (312) 626-6799
One tap mobile
+13126266799,,94042410458# US (Chicago)
+16468769923,,94042410458# US (New York)
Nancy Barrett, Epi 4/PH Informatics Specialist
Hi Riki, will you have a slide to show with the options as you explain them? Also, we can put this on the ELR workgroup call as an item if needed.

Thank you!
Nancy Barrett, Epi 4/PH Informatics Specialist
And I'll be late to the call tomorrow, unfortunately, but I have a question for the community: when does identifying what pronoun a person wishes to use cross with gender identity or is it entirely different (I know what I think, but want to hear what others think).

Also if anyone from New Jersey can share the proposed SOGI legislation that would be great.

Does anyone have a summary slide on sex at birth, gender, gender identity to share?

thanks!
Carmen Pugh, Labcorp Manager State Reporting at LabCorp
Attached is the information I have for the requirements.
Carmen

Carmen Pugh, MT (ASCP)
State Reporting Program Manager
National Office of Quality

128 Maple Avenue
Burlington, NC 27215
labcorp.com<http://www.labcorp.com/>

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Carmen Pugh, Labcorp Manager State Reporting at LabCorp
Attached is the information I have for the requirements.
Carmen

Carmen Pugh, MT (ASCP)
State Reporting Program Manager
National Office of Quality

128 Maple Avenue
Burlington, NC 27215
labcorp.com<http://www.labcorp.com/>

[Logo Description automatically generated]

Important Warning: This email and any files transmitted with it may contain CONFIDENTIAL information, including PRIVATE AND CONFIDENTIAL HEALTH INFORMATION which is intended for the use of the person to whom it is addressed. If the reader of this email/attachment is not the intended recipient, you are hereby notified that any dissemination, distribution, reproduction, reading, or copying of this information is STRICTLY PROHIBITED. If you have received this email in error, please delete the related email and all attachments and notify the sender immediately (by reply email) and/or the Labcorp Privacy Officer at privacyofficer@labcorp.com<mailto:privacyofficer@labcorp.com> or by phone at (877)23-HIPAA / (877) 234-4722.

Riki Merrick, Terminologist at APHL
Yes,
I can try to pull something together that is shareable later...
Nancy Barrett, Epi 4/PH Informatics Specialist
Thank you Carmen!

Nancy
Robb Byres
I had to drop off yesterday’s (4/5) meeting early but I was wondering if the committees that are determining how to send this SOGI data are aware of the impacts of their decisions? In many cases I’m not sure that these committees are aware of the burden that their arbitrary decisions can make.

Any time the standard HL7 message is modified (by adding fields or “pre-adopting” something from a different message) this creates a large impact on every facility and system that uses that message.

Any change to the format of the HL7 message requires modifying every message definition and mapper in our integration engine as well as modifying both the source and destination systems. In Idaho’s case this will require modifying over 200 Rhapsody mappers as well as obtaining and implementing updated LIMS and Surveillance systems. This also requires a substantial testing effort to ensure that the changes have not impacted or broken anything. I presume that the SOGI information will also need to be sent to CDC so again, if there is a message format change, this will require changes to MVPS and re-validation of messages being sent there.

I understand that these directives have to be accommodated but we have to make ever effort possible to accommodate them within the standard message format.

Thank You

Robb
Riki Merrick, Terminologist at APHL
yes, we are absolutely aware of this, which is why we are focusing on trying to be as close to the final, long-term solution as possible, please take a look at all the options - the ones we can do now are OBX as AOEs (but would have to be sent for ALL orders and tests then - so mulitple times in the same message potentially) or as additional OBR in a message.
The issue was that this data may become required for other use cases, besides lab, and then the OBRs won't work.
The reason the V2 Management group thinks this should work is because per section 2.6.1 if you get data (fields or segments) that you are not expecting you should be able to ignore them..
Annie Fine, CSTE
Riki, could you please clarify what the process is from here? When does the HL7 workgroup meet again and how could the public health community represented here and on the APHL ELR call have input into that conversation? I know you are gathering info on Confluence but how will that info be used to develop the value sets and decisions about where the data will go? 

I do recognize that these decisions are really critical for health departments that need to figure out how they will or will not try to develop ways to map and ingest the data into their surveillance systems.  

Also I wonder if we should be commenting on USCDI v3 about these variables since if the data are not captured in the EHR systems and labs in ways that will feed into the ELR messages while maintaining data validity then we will not move forward in this space and just have a big mess. This is where we REALLY need to connect the data collection at health care orgs and labs with the standards used for public health reporting, holistically. I think the conversation probably needs to be broader than just what is happening at HL7 though I realize public health theoretically could participate there but in practice - esp with pandemic - does not really have the time to do so on a regular basis. I should mention that CSTE is about to put out an RFP for someone to help us in gathering input and providing it into standards like this one. So hopefully this will get better. Sorry for long-winded post!
Riki Merrick, Terminologist at APHL
Annie,
the slides had a list of all the calls where SOGI topic has been discussed, but I have summarized here the most important ones for the rest of this week:
The majority of this conversation in the long run happens on the Gender Harmony calls Mondays 4 - 5:30 PM ET - Call info: https://zoom.us/j/7183806281?pwd=WHVnUUlkWWhhcnRaYk9sWWQyOEkvUT09 | Meeting ID: 718 380 6281  Password: 370553 | Search local number: https://zoom.us/u/aciVC9RrJ6 

The lab specific conversations happen on Fridays 1 - 2 PM ET on the OO Lab calls: - call info:  https://zoom.us/j/5100467805 | Meeting ID: 510 046 7805
One tap mobile: +19294362866,,5100467805# US (New York) or +13126266799,,5100467805# US (Chicago)

The next V2 Mangement Group call is Friday 9 - 10 AM ET - we will see, where we are with feedback from the HL7 community at that point - call info: https://hl7-org.zoom.us/j/92167572271?pwd=RE9iMWRFWlNKMlplS2VlVmdOMUcyUT09 | Meeting ID: 921 6757 2271
One tap mobile: +16465588656,,92167572271# US (New York) 

As far as HL7 process: normally this would be handled via balloting, but the timeframe is too short, so I am thinking this will be an official notification from HQ about the short-term solution approved by the WGs that currently edit chapters in v2 base standard. The long-term solution will be balloted in Sept2022 cycle, and then any changes needed in the underlying v2 base probably in Jan 2023 or May 2023 cycle and then published about 3 months after that, as long as there are not substnative changes from teh ballot comment resolution, forcing it to go back to ballot for another round. v2 Management Group may decide to limit that ballot to ONLY comments on that addition to reduce the chances of having to have a follow up ballot.

As far as USCDI V3 comments - the Gender Harmony group has prepared feedback and will submit that, but I agree it is critical that we get the vocabulary correct for that. 
The Gnder Harmony project firmly believes that you should clearly differentiate between Sex for Clinical Use (and probalby not use Sex at Birth, unless that is defined as biological sex, rather than by what is listed on the birth certificate) AND Gender Identity.
Since USCDI is for US, I think the answers should be coded using SNOMED CT to ensure we can be semantically clear in differentiating between biological sex and gender identity.

I hope this helps,
Riki
Robb Byres
It is true that we can just ignore extra fields, however if we did want to use or pass on this information then the work involved with extra fields is significantly more than with an extra OBR

Thank You

Robb
Nancy Barrett, Epi 4/PH Informatics Specialist
Hi Riki and all,
I asked around here at CTDPH and got several responses all of which amounted to - it's being discussed but not determined yet. 
CDC Population Health Care Branch has proposed an optional model for the BRFSS that includes:
MOD26_1A. Module 26: Sexual Orientation and Gender Identity (SOGI)
The next two questions are about sexual orientation and gender identity.
Which of the following best represents how you think of yourself?
1 1- Gay
2 2- Straight, that is, not gay
3 3- Bisexual
4 4- Something else
7 I don't know the answer
9 REFUSED
 
MOD26_1B. The next two questions are about sexual orientation and gender identity.
Which of the following best represents how you think of yourself?
1 1- Lesbian or Gay
2 2- Straight, that is, not gay
3 3- Bisexual
4 4- Something else
7 I don't know the answer
9 REFUSED
 
MOD26_2. Do you consider yourself to be transgender?
If yes, ask: “Do you consider yourself to be 1. male-to-female, 2. female-to-male, or 3. gender
non-conforming?”
1 1 - Yes, Transgender, male-to-female
2 2 - Yes, Transgender, female to male
3 3 - Yes, Transgender, gender nonconforming
4 4 - No
7 DON’T KNOW / NOT SURE
9 REFUSED

We are not currently collection SOGI on birth or death records. Our Immunization System vendor, Envision, is going to have a call with their user groups - SOGI Discovery Sessions (Envision is on the HL7 advisory meetings). For Immunization this is not being reported from EHRs in their HL7. There was a Committee on National Statistics Public Seminars on April 4 that our Health Stats group missed but they are getting the recording. There is a consensus report published that I have not seen yet.
Nancy Barrett, Epi 4/PH Informatics Specialist
Why am I mentioning all of this? 
1. There is a lot of activity going on in different realms that do not seem to be coordinated - or if they are, we in the PHAs aren't aware of all of these. So are different recommendations going to come from different places?

2. Per Robb's point, any change causes a ripple effect in the systems. And since we seem to be pre-adopting at a rapid rate, when do we just stop the piecemeal additions and go to a new ELR standard that can be adopted nationally and systematically?

3. Collecting this information is important for certain health or public health followup, but why from lab reports? We are now continuing to hold labs 'hostage' to require them to collect information that really should come from other sources. Sorry, but should one state push this when the efforts and interpretations do not seem to be effectively coordinated? 
Nancy Barrett, Epi 4/PH Informatics Specialist
Where should we go now? 
1. Adopt the most logical initial descriptions (NJ at a minimum or the BRFSS seem good) to code but have the ability to add additional more specific codes (child codes) as needed. I mean developing the SNOMED codes for this.
2. Adopt in a fashion that can be used by reporting from EHRs whether in CDA, VXU, ADT or other messaging as well as in the ORU messages.
3. For ELR, adopt in a way that will have least impact on states who choose not to use this information from ELR.
4. The NJ act says "labs licensed by the NJ Dept Health" - I'd like to know the impact for labs not based in NJ - its my ignorance but do commercial labs have to license in each state or just the state their operations are based in?

What can CSTE do to help on this? 
Mark Dittman
I am opposed to forcing this on labs. One exception I could see is hospital-based labs on centralized EHR/EMR systems where all patient data is available to the lab for ELR message population. Then we need a spec. As bad as AOE data is, with very few PA facilities having implemented that for COVID, I would prefer it be handled as an add-on AOE component.

Licensing in PA is required for any lab, in any state or territory. We continue to find labs conducting testing which are not licensed and have to pursue those as they are identified.

Labs need to push back on this as the impacts are mainly on their business and systems. State impacts are going to vary because if unsanctioned data begins coming in our workflows are at risk of errors. For PA, if the data is sent as AOE as one example, we must make changes to our process or we will have large numbers of errored messages that will have to be manually addressed. We cannot ignore the presence of the data in an ELR, we have to triage the format/content whether we consume the data into a PA-NEDSS report or not.
Heather Crawford
Oregon is interested in conversations about creating HL7 standards for the submission of SOGI and reaching consensus about the questions that should be asked/the possible responses.  How does one take part in the Gender Harmony discussion?   

In contrast to the CDC Population Health Care Branch proposal, Oregon currently frames SOGI in the following manner:
Oregon also has a requirement which requires REALD (race, ethnicity, language or disability ) to be reported for all COVID encounters by providers in Oregon.  We are curious whether other states are doing similar work and how to approach adding these REALD questions to be added to reporting standards.
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Riki Merrick, Terminologist at APHL
This page is now "published": https://confluence.hl7.org/display/V2MG/Short+Term%3A+SOGI+Data+Exchange+Profile

Any changes going forward will be clearly identified in a revision log at the top of the page.

I hope this helps. Please look for the September ballot cycle as we will be balloting the LONG term solution for v2.9.1.
Riki
Nancy Barrett, Epi 4/PH Informatics Specialist
Thanks Riki!

Will labs be letting states know when they start including SOGI? I can put this on the extended ELR question list also.