Hello,
Great questions and I'm sure a lively discussion will ensue ;)
Regarding, "The Cures Act is mandating FHIR capabilities for all health care providers (clinics, health systems, labs and others)." While it is true patients can request health data per Cures Act, and laboratories amongst other providers must provide in accord with Information Blocking provisions, FHIR is not required of all.
I'm not aware of ANY LIS (yet) that has FHIR functionality as Craig indicates, V2 (and sadly paper and fax as many of you know form the pandemic) are still what are in use nationally. When FHIR for daily lab reporting needs is eventually developed, it will also need to be CLIA compliant to meet US regulations and so laboratories can actually use it. Currently, US Core FHIR examples are missing key, basic information needed for laboratory data, such as the actual name of a test order or result, the specimen type, etc. See HL7.FHIR.US.CORE\Erythrocytes Example - FHIR v4.0.1 The response to my ballot comment to bring it up to minimal standards was to add the italicized disclaimer at the top (that examples may lack info CLIA requirements). However, as Riki and I pointed out developers are already using these examples for their implementations. Apple Health allows "sorting" of lab results alphabetically so all "interpretations" whether for a path report, genetic testing, coag panel, micro result, etc are all listed under "I" in their app and not with the context of the other lab data in their panel. As you can imagine, it's the Wild West currently and a patient safety, much less data quality issue.
HL7 O&O has begun work on a lab orders workflow and there is a FHIR IG for order catalog (service catalog) to support laboratory compendiums (aka CLIA specimen collection manual) and equivalent to HL7 V2 eDOS or electronic directory of service. It's unclear how many have voluntarily adopted as there are no requirements for laboratories (as sender/reator) and EHRs (as receivers) to use. As you can see it will be quite some time before IG are available in FHIR for the current v2 LOI (Lab Orders Interfacing), LRI (Lab Results Reporting Interfacing), and ELR (Electronic Reporting to Public Health). Much needs to done to build and ensure all types of lab data, including reflexive orders/results such as seen with susceptibility testing, pathology, genomics, etc. are able to be supported in FHIR.
Even if the IG were available, each information system the data flow through would need functionality to support and in accord with regulatory and legal requirements. As you may know, most laboratories (except those as part of eligible hospitals) were excluded from Meaningful Use incentives and information system vendor certification requirements and standards adoption requirements.
Hence there is a variety of voluntary adoption of standards from paper/fax to v 2.31 messages to v 2.51 messages. The one major driver of adoption of standards is ELR reporting requirements (which as you know varies somewhat from jurisdiction to jurisdiction). It is great ELR standards were included as part of MU certification requirements so LIS and EHR vendors would have functionality (theoretically) to support mapping to LOINC and SNOMED CT, messaging in HL7 v 2,51 and interfacing to PH jurisdictions. How that occurs varies across vendors (EHR and LIS). For laboratories that are part of a health system where the EHR and LIS is the same vendor and with a shared database, often the EHR product side is certified (usually with a public health reporting module) and once laboratory results are verified and released from the LIS, they populate the EHR side for clinical care and when meeting PH reporting requirements (ELR, eCR, HAI, etc) are utilized by the PH reporting module (and sometimes remapped to meet encoding requirements) and the message is sent to PH, meeting these requirements. In cases where there LIS and EHR vendors differ (i.e. Meditech or Orchard or Sunquest LIS (to name a few) and Epic, Meditech, or Cerner EHR (to name a few)), ELR is typically performed via an interface from the LIS directly to Public Health. Given the interface to the EHR and PH are different, the mapping and reporting may differ across these interfaces. When a non hospital laboratory (e.g. independent/reference, government, VA/DOD, blood bank, physician office lab) is reporting, their voluntary standards adoption varies from some to all encoding, to different types of HL7 interfaces. A number of the large reference labs may adopt many codes like LOINC, but there are are still gaps, and not all have SNOMED CT for specimen type, specimen source, qualitative result values, organisms, etc. as many of you have reported during the pandemic. Even Mayo reported during the pandemic, it delayed their upgrade from HL7 2.31 to HL7 2.51 messaging.
The good thing about standards requirements for ELR is it has required all laboratories reporting to meet these requirements. When I was at CAP on the CDC/ONC Laboratory Interoperability Collaborative (LIC) which aided over 1200 hospital labs with ELR to their PHA (we worked with over half the jurisdictions), one of the most frequent questions we heard is Who is the LOINC police to ensure mapping is done correctly? The answer is PH has been the only entity "enforcing" requirements as part of ELR onboarding. I'll mention there is variability across jurisdictions and many may relax said requirements given the desire to get any electronic data as a vast improvement over paper, fax, postcard reporting and to reduce the burden on PHS receiving the data. Given the strain of the pandemic, a number of jurisdictions suspended onboarding of other infectious diseases to focus on COVID needs. The good thing is HHS regulations mandated reporting of anyone performing COVID testing so it closed gaps where non traditional performers of said testing would still be required to report to aid PH and national responses. (This is great, but given consumer performed testing is not required to be reported, with the this shift, less is known about disease prevalence in many areas, especially if individuals do not share results outside of themselves, whether pos or neg.)
I realize the above may not reflect what's occurring in each jurisdiction/PHA, but an overall current state of what's occurring from a laboratory perspective, vendor functionality, policy/regulatory. as it all impacts laboratory data interoperability/usability. I'll add SHIELD is working on a national laboratory data interoperability strategy and other initiatives like the Laboratory Community of Practice (of which Riki and I are a part) is working on the Specimen CrossMap table with Specimen type, source, collection procedure terms and SNOMED codes. I'd love if those collecting specimens provided complete encoded details about specimen type and source so performing laboratories can pass this along to PH as gaps are still occurring as many of you know.
Given USCDI was mentioned, there was success in adding specimen type to version 3, but source is still not a requirement to be supported along with other data currently in the HL7 v2 ELR guides. I hope these are all part of USCDI in the future to parallel v2 requirements. I'll also mention where FHIR is being used for lab data (i.e. apple health app, some EHR apps), v2 data is often converted at the EHR (or other downstream system) so the content can be sent in FHIR. It may be that PH may wish to start converting data to FHIR for their use cases too. I strongly encourage such conversions are validated to ensure information remains accurate (clinically, technically, structurally, coding wise, etc.) and works as expected/intended as I've heard of some challenges in this area, especially when not a 1 to 1 match (Craig may be able to share more as he's chaired the v2 to FHIR workgroup)
The good news is these laboratory needs have gotten the attention of many nationally from those at federal agencies such as FDA (especially with surveillance and real world evidence needs) to ONC and Sequoia's Data Usability Workgroup (although their recent document excludes lab data at the moment due to these complex needs.)
Thank you for standing up this workgroup/listserve to communicate and work on these needs vital to public health as well. Please let us know if questions or clarification or further detail is needed.
Cordially.
Andrea