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Date: March 24, 2023
Time: 1PM ET
Coordinates: Join Zoom meeting: https://zoom.us/j/5100467805 | Meeting ID: 510 046 7805 | +1 929-436-2866-US (New York)
Marti Velezis (Sonrisa/FDA), Hans Buitendijk (Orcale), JD Nolen (Mercy Children’s Hospital), Riki Merrick (Vernetzt, LLC / APHL), Andrea Pitkus (UW), Kathy Walsh (Labcorp), Sara Armson (ONC), Sheryl Taylor (NIST), Jorge Lopez, Craig Newman (Altarum), Ralf Herzog (Roche), Scott Fradkin (Flexion), Rob Hausam (Hausam Consulting)
Co-chair: Hans Buitendijk
Scribe: Hans Buitendijk, Riki Merrick
- Quorum (Co-Chair + 2) Met
- Standing Topics
- Special Topics
- Workflow updates
- JIRAs Triage
Previous Meeting Notes
- Waiting for CMS - 1 June check-in
2023-02-24 OO - LAB/LIVD has PAC feedback discussion
New Rule on Race/Ethnicity from OMB
Due date is April 12, 2023
- They now want to conflate 4 different things into 1 field: race / ethnicity/ nationality / lineage = descendants of slaves or Asian immigrants before a specific time
- Not good to conflate – currently those are different fields in the standard
- They asked questions of which solution would work best – need to better understand the options they are presenting in the questions to decide
- Kathy will create the first draft - for review next week
HL7 already submitted OMB comments - will want to find the text - see news or policy statements
New Rule on Race/Ethnicity from OMB
- Federal Register :: Initial Proposals For Updating OMB's Race and Ethnicity Statistical Standards https://www.federalregister.gov/documents/2023/01/27/2023-01635/initial-proposals-for-updating-ombs-race-and-ethnicity-statistical-standards
- <from prior call chat> Hans mentioned “trickle down” - the reason we had race and ethnicity terms added in HL7 started with V2 is because CDC requested Patient Administration (Chpt. 3) to add (HL7 V2.4 I think) because CDC had to conform to federal requirements. The same terms used for Census Bureau data ‘trickled over’ to other federal agencies. If this new request for comment proceeds to a new proposed then final rule, it would probably “trickle down” eventually impacting CDC, ONC, CDC (thus eventually healthcare standards) etc. See 1997 link and you will recognize correlation to HL7 V2 of race and ethnicity. Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity | The White House (archives.gov) https://obamawhitehouse.archives.gov/omb/fedreg_1997standards
New Rule on Race/Ethnicity from CDC
Due date is April 14, 2023
- OMB 5 categories – there will be changes there, too
- Detailed list is being expanded and some codes are being retired – these codes still roll up into the 5 OMB categories
- Ultimately OMB categories will have to be updated, once those rules are out
- Because they are proposing a number of concepts be retired – what are we doing with those?
- Depends on the use of this data what concepts are appropriate
- Looks like they are using NEW codes for ALL concepts, even the ones they are not replacing?
- They are building on what was used for the census in 2020
- This seems to be more of a "make other groups within HL7 aware of this" so they should make these comments like PA, PH, Terminology Infrastructure and cc PAC - Ulrike Merrick to draft and send to the list first
- For those in clinical interpretations this list is not complete (ethnicity for example around Jewish ancestry) – that is OO comment
- Changes for the longer race list https://hl7.org/fhir/R4/valueset-referencerange-appliesto.html will affect this value set for reference range characteristics
- For cancer do want to know, if folks are multi-racial – but should not have that as special category
- US core is only 0..1 – that needs to be fixed
- None of these concepts have definitions
- In ethnicity – also some terms include male/female versions others don’t – should not be mixed in here either
- CDC Race / ethnicity National Webinar scheduled for Tuesday 3/21 1-2 PM ET: Please click the link below to join the webinar: https://cdc.zoomgov.com/j/1615394362?pwd=ZlNSNGRnbjUrZ0lmWW1uUzMwL0hlZz09 Passcode: 595705@1a
PHIN VADS Hot Topics at https://phinvads.cdc.gov/vads/SearchVocab.action first mentions commenting and second gives links to documents.
Comments on the CDC Race and Ethnicity Code System (CDCREC) will be accepted until April 1, 2023. Artifacts can be found by viewing the 2022_RaceAndEthnicityFinal_TablesforPub_Final. In addition, the rationale for the prepared code system is located in the Background file. For technical assistance and support concerning the updated CDCREC, please email RECODES@CDC.GOV or PHINVS@CDC.GOV mailboxes.
CDC Race Category and Ethnicity Group
List of concepts present in CDC Race Category value set which is based upon OMB recommendations and list of concepts present in Ethnicity Group value set which is based upon OMB Race & Ethnicity.
FILE: 2022_RaceAndEthnicityFinal_TablesforPub_Final.xlsx - Race and Ethnicity Download File (Full Code System, relationships, and Hierarchy codes)
FILE: 2022 Race and Ethnicity Code System_Background_Final.pdf - Background and Purpose
Update from FHIR Lab Workflow call
- Cross walk on DME/PAO topics with that team.
- Next week to go through a library/catalog of use cases starting from catalog to order to etc.
- Next time for LIVD 4/7 call
Add JIRAs for Next time – related to Lab
- Test kit identifier for USCDI v4 – comments are open till April 17 (specific questions and anything in level 2) HITACH Lab WG ( https://www.healthit.gov/hitac/events/interoperability-standards-workgroup-29) is providing feedback on lab data elements – one of those is the unique test kit identifier – if we restrict to UDI, then it might be hard, as not all test kits have UDI – use device name and manufacturer at least – looking at how to support:
- In FHIR: have deviceName and ManufacturerName
- In LRI we use OBX-17.9 we created the rule to concatenate manufacturer and kit name and you can repeat that, but if you want to support use of PRT, we are missing device name element
- For Test kit = reagent - use the inventory segments for inside the lab communication
- IHE LAW supports sending model name and manufacturer but in OBX-18
For COVID-19 require to report test kit to PH – this is expected to expand to other tests
SHIELD is looking at how do we identify the test to know if we can merge the results in trending in the patient chart – and the method is not harmonized to an international standard
In Europe we have TECON = Ralf will share the link – compare QC results of labs even if the kit and instruments were the same still big issue
What data does the provider need to know to merge results – this still needs to be determined
But we still should fix PRT to be able to send names of devices (equipment / test kits)
Motion to include deviceName in PRT as ST 0..1 to align with OBX and FHIR to convey that. Ralf Herzog, Riki Merrick
- No change in clarity of what to actually put into this field
- Need to look at EI to communicate deviceName and manufacturer name
- check FHIR = http://hl7.org/fhir/R4/device-definitions.html#Device.deviceName
- check http://www.hl7.eu/refactored/dtEI.html
- check http://www.hl7.eu/refactored/segPRT.html
- check LRI on device identifier
- Will review with initial JIRA April 14 before we vote.
Defer to SHIELD Community on the questions on what else to communicate with a result to whom, how to consider re-agents, QC, other data and as a result.
Add JIRAs for Next time – related to Lab
- Andrea Pitkus 1:09 PM
- can you point us to the HL7 submissions
- Andrea Pitkus 1:15 PM
- DO LISs have any functionality to capture, store, and message UDIs? Not aware of any esp when COVID was 1st time this became a requirement
- IVD package insert info/GUDID (UDIs) have typically been outside the LIS
- Andrea Pitkus 1:18 PM
- or multiple reagents for a single result value?
- Andrea Pitkus 1:23 PM
- I'd add also if intermediary information systems don't have functionality, they won't be messaged through and dropped, etc.
- Andrea Pitkus 1:24 PM
- To Ralph's point though, if this expands beyond COVID, multiple reagents/test kits are involved, it could get really complex and not feasible.
- agree LOINC was never intended to provide instrument/test kit level info
- Andrea Pitkus 1:36 PM
- with the PR solution could it support many UDIs if needed
Call Adjourned at 2:01 PM ET
Next Meeting: 3/31/2023
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