Feedback requested on drafted comments regarding Lab Data Interoperability in ONC's HTI-1 Proposed Rule
APHL has shared some drafted feedback on the request for public comments from ONC around Laboratory Data Interoperability in the HTI-1 Proposed Rule. Overall, CSTE supports including lab orders in the promoting interoperability program and including lab technology & standards in certification criteria. CSTE would like to align with APHL’s drafted responses, and we are requesting your input to inform CSTE’s comments.
Please review the Word document & slides at the bottom of this post with responses from APHL to the 5 questions listed below. The Word document contains some background that may be helpful for approaching the RFI questions (can be collapsed if not needed), and the presentation slides contain the same information, presented in a different format.
Please review the Word document & slides at the bottom of this post with responses from APHL to the 5 questions listed below. The Word document contains some background that may be helpful for approaching the RFI questions (can be collapsed if not needed), and the presentation slides contain the same information, presented in a different format.
Please indicate if you agree/ disagree with the responses in the documents to the 5 questions below, and/ or if you have additional comments. PLEASE REPLY TO THIS POST BY COB FRIDAY, JUNE 9th.
1. Which implementation guides or other standards should ONC adopt in certification criteria for health IT supporting transmittal and receipt of laboratory orders, laboratory results and directory of services?
- Agree / Disagree (explain)
- Additional comments
2. The utility and maturity of existing HL7 v2 and C–CDA standards supporting laboratory interoperability and the impact of moving to FHIR-based laboratory data exchange.
- Agree / Disagree (explain)
- Additional comments
3. What barriers would additional health IT certification criteria for laboratory interoperability create for developers and other interested parties, and how might this affect adoption and use of such technology?
- Agree / Disagree (explain)
- Additional comments
4. Would developers of laboratory information systems or in vitro diagnostics systems that have not traditionally submitted products for certification under the Program seek out and benefit from certification to criteria relevant to such developers' products?
- Agree / Disagree (explain)
- Additional comments
5. Are there any other steps that ONC and HHS should consider taking to advance laboratory interoperability?
- Agree / Disagree (explain)
- Agree / Disagree (explain)
- Additional comments
My responses:
Q1.
Lab Orders: Agree the standards listed. My concern would be are labs, including state public health labs, ready to implement the standards. But if this helps push it forward that would be helpful
Lab Results: Agree that LRI R4 and the value sets for LOI/LRI/eDOS should be adopted. Also agree that lab result reporting to public health should start moving to the later standards like the PH Profile in LRI R4. I am neutral on the results between providers, but use of C-CDA would be consistent with the eCR based standards. FHIR I would not adopt right now but mention as a future consideration.
Directory of Services: not sure for this one.
Q2.
Agree there should be a path forward. So my opinion is that this question should be addressed in the proposed study that should not only generate an assessment and identify challenges, but gaps and proposals to address them, and a potential set of next steps and timelines (if possible), and a ROI/cost-benefit analysis. It also does seem that additional laboratory-related certification criteria is needed but I wonder if there needs to be adjustments to CLIA requirements as well so lab are empowered to make changes.
Q3. This one is more completed.
agree with the 3 items: system certification providing higher level of consistency; certification of options, i.e., profiles vs full guides; separate certification of semantic aspects from syntax.
I'm unclear on what the last bullet means - does this relate to what Dan Chaput was discussing on removing cert versions?
Re: AOE
During COVID-19 we asked labs to provide several AOE in lab messages. Which some labs did - but often those were unknown or empty. Also, CT did not use them. So agree we need to evaluate further if eCR can augment lab results for AOE. That should be assessed.
If allowing labs serving walk-in patients could use eCR instead of ELR - yes IF it were assessed that meets PH reporting needs. I do not know enough about collection of the AOE questions for walk-in patients to know if using an eCR pathway would improve AOE reporting - if the data isn't collected the actual pathway for reporting doesn't matter, you still don't receive the information.
Q4. Agree IF the facilities using these systems qualify for incentives. Cost may have an impact to not being able to push certified systems.
Q5. Agree. What responsibility will PH have to take on to verify that a reporting lab is using certified product or a site-specific implementation? Does PH have staff who have that knowledge base to do that?
General comments: A phased approach is likely best. I think the assessment should include that - what would be required for a lab to move to the more flexible/modern processes.
Q1: I find it extremely hard to believe the majority of labs, regardless of scale or type, will be able to meet short-term dates for standards. We still have labs that have been doing ELR for years that need constant hand-holding.
FHIR... I have no interest in any way of implementing FHIR and cannot see it being a 'need' for years to come as most providers will be unable to adopt it. At an interjurisdictional exchange level, I want to see CDC implement an actual standard format and standard of practice that can be distributed to all states for implementation and not forcing each jurisdiction to develop and implement their own methods from scratch.
Q3: AOE comments.... "Junk". Caused more issues than it solved with COVID and the vast majority of our providers never implemented it and several that did rescinded the AOE elements after a time. They must be in a strictly implemented format. The last thing is more useless junk in an eCR. It's 99% garbage now, no need to make it worse.
Q5: No way will I advocate for or implement some sort of validation or tracking of whether providers have a compliant system. If the provider can send me data in one of our accepted formats, that's the end of my concern. Validation should never be the role of the PH entity. We don't fund it, we get zero funding to police it, why would we want yet another burden to make policy people happy?
For WA we have drafted a short response that is still not cleared our agency approval process. So please note these are draft and not official agency or WA State position yet.
* Laboratory Data Interoperability Request for Information (23847-23848
* DOH appreciates the opportunity to comment on the RFI for lab data interoperability. We leverage this in two primary ways. We need to receive lab orders at our public health lab and return results. We also need to receive electronic lab results for notifiable conditions. Similar to eCR we feel the best path forward is to require current HL7 V2 2.5.1 messages as they are well implemented while also allowing for FHIR ELR messaging for both ETOR and ELR. This will allow a transitionary period for the move to FHIR while supporting what most PHAs and labs can do today. One challenge is that labs outside of a hospital do not have to have their LIMS certified to ONC standards. This means many of our ELR submitters may not be able to report the data required in USCDI or our own state rules. Exploring certification for at least exchange purposes for LIMS may be a path to pursue.
Sincerely,
Chris Baumgartner
Deputy Chief Informatics Officer | Center for Data Modernization and Informatics
Executive Office of Innovation and Technology
Washington State Department of Health
chris.baumgartner@doh.wa.gov<mailto:chris.baumgartner@doh.wa.gov>
206-418-5530 | www.doh.wa.gov<http://www.doh.wa.gov/>
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I sometimes work flexible hours, so while it suits me to email now, I don't expect a response or action outside of your working hours.