Data Usability Workgroup

How does your organization exchange data today with consumers?

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    • #32164 Reply
      Hera Ashraf
      Keymaster

      How does your organization exchange data today with consumers?
      o HL7v2
      o HL7-CDA
      o HL7 FHIR
      o Other: please describe

    • #32987 Reply
      Andrea Pitkus

      Laboratory data from it’s origination from the performing laboratory’s LIS is exchanged in HL7 v2.51 messages to downstream entities whether the hospital EHR, Public Health (ELR), physician EHRs (for outreach/referral testing), other laboratories (LIS to LIS for referral lab testing from smaller facilities), to/from reference labs (for tests sent out), and ingestion of Point of Care Testing devices/software to LIS and sending it out to providers from the LIS.

      HL7 FHIR isn’t yet mature for lab data (including pathology data) (to be exchanged in CLIA compliant manner) for daily use at its origination from LIS to EHR, from LIS to LIS, LIS to Public Health, etc. Some EHRs may be sending it on to other entities, but most likely translating HL7 2.51 messages they consume from the performing lab to other entities. HL7 WGs are working on PSS for cancer reporting from pathology LIS, while O&O is working on lab use cases for reporting using Diagnostic Report FHIR Resource (to support multiple report sections, microbiology reporting, connections to Service Request for Lab orders, reflex orders/results and much more) and meet CLIA requirements so FHIR might be used for lab data at a future point.

    • #32988 Reply
      Andrea Pitkus

      For patient performed testing, such as a self monitoring glucose (SMB), the patient performs the test on their meter and it is entered at the point of order entry (CPOE) into the Ask at Order Entry (AOE) question for the test. The patient result is sent within the order to the laboratory who performs the venipuncture glucose and results it back to the ordering provider along with the patient result to the ordering provider. There are separate result items for each as they would have different reference ranges and need to be kept distinct in the LIS and EHR.
      Here’s an example from a laboratory test catalog: https://testcatalog.duke.edu/#/test-detail/LAB6380/1230120251
      These orders and results are exchanged using HL7 2.51 messaging.

      LISes don’t have functionality currently to consume HL7 FHIR as I understand from several major vendors. (For any patient performed testing.) Further this is magnified with COVID as the newer paradigm of patient/consumer performed testing at home with In Vitro Diagnostic (IVD) kits with EUA approval such as Abbott’s Binax now Ag tests available at Walgreens and CVS pharmacies now, Lucira, etc. might have their own phone app (perhaps using FHIR) and/or web portal to collect Ask at Order Entry (AOE) questions/responses as required by HHS COVID regulations, and marry them with the patient result. However, it’s unclear to many experts as to where this data is going (which information systems and how). EHR vendors only have FHIR read only functionality and unable to ingest the data if it were to be sent from phone app/portal using FHIR.

      If the patient present to a provider, the provider may need to hand enter their results (and where and how)? Once the provider is involved then electronic Case Reporting (eCR) laws apply. However, eCR functionality isn’t pervasively available in EHRs across the country and thus CDC has developed a FHIR based eCR application that can be used for physicians to meet these reporting requirements by law.

      What has been clear for any consumer provided lab data is that it must be distinguished from health professional/laboratory performed data in the LIS, EHR and downstream systems. From a laboratory perspective, one wouldn’t want these outside data to cause issues with laboratory accreditation requirements, etc. From a physician perspective, there is a different level of trust with these data with medical/legal implications. One doesn’t know if a home pregnancy test was dropped in the toilet and invalid, nor if a home COVID test was swabbed from an ear or their dog’s nose/mouth to obtain a negative result. (Some companies proctor specimen collection to help avoid these data quality issues).

      I’m also aware of app developers trying to use HL7 FHIR for collection and exchange of data from consumer devices like fitbits, watches, phones. The issue here is since these data are not built in EHRs, LISs with data dictionaries that facilitate collection of discrete data (results, result values, orders) and encoding with standardized terminology (i.e. LOINC for lab results), said developers are often making up their own names for data or trying to use terminology names (that may be long, cumbersome with unclear meaning to consumers, etc.) on devices. One developer advertised to their developers User Group Meeting in using LOINC Long Names for glucose results across their apps, devices, etc. despite such a recommendation that is contrary to the LOINC User’s Guide that said such names shouldn’t be used for displays. Smaller device displays may also have truncated names, terms, etc due to a lack of space which could result in patient safety issues. Although some EHRs and LISs may provide lab results in their patient portals, others may also allow consumers to receive them on their iPhones using FHIR within Health apps. If these data are modeled using FHIR observation, instead of Diagnostic Report, they may be missing key information like reference ranges, specimen information, etc as required by CLIA regulations, and/or unable to be rendered or read by apps due to some data being modeled as FHIR Diagnostic Reports while other same data by another vendor being modeled as FHIR observation (think a hemoglobin level). This can cause all kinds of interoperability issues, and potentially patient safety issues.

      A number of laboratories still provide paper reports to consumers/patients, but I didn’t see that as an option. This has also caused issues as we’ve heard providers complain that fax and paper results aren’t very interoperable.

      Some laboratories have developed their own apps (i.e. LabCorp, Quest) where patients can get results via the app directly from the performing lab using FHIR, but most all laboratories are sending data to consumers via some sort of web portal, especially in light of the information blocking regulations that went into effect April 5, 2021.

    • #34590 Reply
      Riki Merrick

      If consumer = patient I agree with Andrea’s notes above. Most labs will provide the results on a web portal – they may provide capability of download via pdf or potentially in a format consumable by a PHR or print out paper.

    • #36032 Reply
      Tom Bronken

      Trinity Health utilizes FHIR apps and patient portals.

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