Actual text:
https://www.healthit.gov/sites/default/files/page/2024-07/ONC_HTI-2_Proposed_Rule.pdf
Background links:
Announcement page with fact sheets: https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-patient-engagement
Current rule for cancer reporting (move up for ANY reference to current rule):https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170#p-170.315(f)(4)
Cornell Law site for referencing current rule as alernate to above: https://www.law.cornell.edu/cfr/text/45/170.315
Due date for feedback is 60 days after 8/5/2024 => 10/4/2024
Comments for submission
#1 - Requesting clarification about which code system version listed in the HTI-2 is the overwriting one for the minimum version, when there are differences between the version listed in $170.207 vs versions called out in USCDI V4 referenced in $170.213 or a version specified in an implementation guide for any particular subsection. Example here is LOINC 2.76 in $170.207vs LOINC 2.74 in USCDI V4 in 170.213. HIT systems should be using the most recent version at time of certification.
#2 - Need clarification why LRI is listed as a standard under 170.315.(a)2. As currently written, this section does not provide enough clarify about which actor function for a use case requires which standard - this should be split out into specific use cases and describe the standrds for each actor:
Use case provider ordering from laboratory
actor EHR-s uses CPOE and then LOI to create and send orders
if applicable: HIE must receive LOI, perform any transformations / translations and send the modified order using LOI
actor LIS receives and validates LOI order
Use case laboratory ordering from reference laboratory (which could be a PHL or a bloodbank, too)
actor LIS uses CPOE and then LOI to create and send orders
if applicable: HIE must receive LOI, perform any transformations / translations and send the modified order using LOI - there should be a requirement that no content is lost (like specimen details or AOEs)
actor LIS receives and validates LOI order
If intent is to support use of LRI for results coming back after electronic ordering, then
Use laboratory sends results to ordering provider
actor LIS creates result(s) and uses LRI to send result(s)
if applicable: HIE must receive LRI, perform any transformations / translations and send the modified order using LRI
actor EHR-s receives and validates LRI result(s)
Use case laboratory receiving results from reference laboratory
actor LIS creates result(s) and uses LRI to send result(s)
if applicable: HIE must receive LRI, perform any transformations / translations and send the modified order using LRI
actor LIS receives and validates LRI result(s)
Question: Does this include sending a copy to ordering provider?
Question: Does this include an HIE?
could be included in all of these use cases - so should be added into the use cases
For HIEs to be certified HIT, there should be a requirement that no content is lost (like specimen details or AOEs at the data element level or at the content level when mappings are not equivalent)
OTHER USE CASES?
Notes 8/27/2024
Can we use a software to figure out how the data is moving and how the content may have been changed?
<Ana or Ingeborg to provide the names of the implementations where this software has been used and maybe links to a publication that helps better understand the functionality>
this is more for data analysis in intergrated systems
it would require system errors to be reported to a central system
not sure we can call out a specific software in the HTI-2 rule - this is more importnat to include in implementaitons, not sure this can be part of the certification aspect.
From Chat:
We may wish to comment on to emphasize detailed specimen type, source, laterality, procedure for specimen collection are included with the order when collected so it's transmitted to the performing lab and available for PH for reportables whether via ELR or Cancer Reporting, etc.
John Snyder (NLM) 12:49 PM
I only brought up the HIE question because some HIE's provide mapping services between local code systems and from local code systems to LOINC and/or SNOMED. I wasn't sure if this is still a valid middleware layer that should be taken into consideration because the data isn't purely being passed through from source to target.Andrea Pitkus 1:00 PM
What do you consider a system error, how is it modeled, stored, collected and transmitted to achieve what you described?
Sections of interest for this group:
Use of USCDI V4 by Jan 2028
Lab Class elements included:
Discussion on 7/30:
support USCDI V4; but V5 is not different from the lab class data element perspective
so still missing: test kit identifier and instrument identifier
Versions for LOINC and SNOMED CT should be much later versions in HTI-2 - at this rate they would be 5 years behind if looking at USCDI specification (with V5 it would be only 4 years; sounds like LOINC version is decoupled in HTI-2 from the USCDI LOINC version called out - how would that be reconciled?
LOINC best practice is to be within 90 days of release dates - so this would be way beyond what HTI-2 calls out
Sidebar - collect comments for V5 feedback has moved here: USCDI V6 Suggestions
Require LOI for CPOE exchange
Discuss the version called out R1S4 vs latest which is E5
Discussion: Highlight the differences between the versions
Specific asks:
Functional requirement document for LOI - this does not exist as a document to cite - should we submit the list of requirements with the comments? Need ot be sure we have clear definitions around each of the words used in the rule
specific profiles vs calling out IG in entierty - LOI_PH profile will support data elements needed for potentially reportable diseases, maybe just call that out in support of the labs that have to send LRI_PH/ELR messages
CPOE was in MU before, but even after it was implemented in the EHR-s, but the electronic order was nt actually exchanged with the lab - this is version of the rule is trying to remedy that
Require LRI for CPOE exchange
Compare to Standards WG elements code system report?
Discuss the version called out R1S4 vs latest which is E5
6Aug24 Call Discussion
FDA schema for FDA for UDI exchanges
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
Messaging info included in LRI Guide, beginning on page 38 for Pandemic Reporting. Page 42 includes Device Identifier in Table 4-4 and where it is used., while pages 47-51 indicates how it’s messaged and provides examples.
Robyn may have some suggestions from their EHR WG after they complete their review.
Question: What is relationship between USCDI v4 requirements and USCDI + requirements?
USCDI is in rules for certification of Health IT. No levers for USCDI + right now. Where can USCDI + be added in future.
https://uscdiplus.healthit.gov/uscdi Link to USCDI + Portal showing Domains and Use Cases such as Cancer, Maternal Health, Laboratory Data Exchange Use Case, which include Laboratory Data Class elements and details on coding, whether the element is in USCDI, etc. Laboratory Data Elements and which Use Cases they are included s shown here: https://uscdiplus.healthit.gov/uscdi?id=uscdi_record&table=x_g_sshh_uscdi_uscdi_class&sys_id=7d8085628745b95098e5edb90cbb35e5&view=sp .
Procedures
Use of Service Request vs Procedure vs Observation for lab orders.
Suggestion that the HL7 call for modeling of new USCDI 5 (CGP call) may be appropriate place for feedback. Sessions early draft v5 modeling before they were final. Broad Orders element to specific Laboratory Orders (and Medications, Procedures, Clinical Tests, ). Riki call time and information?. Meets every other week on Wednesdays on USCDI, other topics on off weeks. Certain elements on certain calls.
Use of FHIR Cancer Pathology Reporting IG
Will need to examine if this IG covers all CLIA elements (LOI and LRI have a specific mapping to CLIA elements) (riki.merrick to link the CLIA mappings to V2/CDA/FHIR!!!)
mCode aligned with USCDI, but Cancer Pathology Reporting is not
this is different functionality from what LIS usually support (which in the US is V2)
Also not sure if PHAs = cancer registries can receive
The Cancer Pathology IG Workgroup recognizes there are issues with the current FHIR IG supporting laboratory needs. Recommend using V2.5.1 messaging to get information to cancer registries, with goal of adding a section to the LRI implementation Guide for pathology specifics. Until then support use of LRI V2.5.1 IG referenced for laboratory results reporting. Goal is to update the FHIR IG to meet pathology reporting requirements with a transition at a later date.
Update ELR to LRI PH Profile
Need to produce a dIfferential list to better understand what the impact might be
CSTE and HL7 PH WG will comment on this one - ELR is in production in many places, would need to understand the ROI to replace existing interfaces (if the incentives would drive into that direction - need to look for unfunded mandates to update to these on the lab and PHA side - think immunization registries not being supported in MU1 days to receive the data feed - and where patient attributes that are part of MU 1 in EHR-s, but not supported in LIS in non-covered entities / support for LIS module for test set ups (LIS functionality may be different across separate lab domains
LOINC, SNOMED CT and UCUM all mentioned
Overall comment:
can certify the EHR-s and the PH-s =, but need to also include the LIS, which is not currently called out
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