About the ISA

Comment

Over recent years, the…

Over recent years, the healthcare industry has undergone a huge digital transformation due to the need to completely update its existing infrastructure.

ISA Comments from Washington State Department of Health

Please refer to the attached comments from the Washington State Department of Health. Thank you for the opportunity to comment.

WA_DOH_Comments_ONC_ISA_2023.pdf

AMIA's Comments on the ONC ISA 2024 Reference Edition

Please see attached the American Medical Informatics Association's feedback on the 2024 ISA Reference Edition. Thank you for the opportunity to comment.

AMIA-ONC-ISA-Public-Comment-Letter.pdf

AMIA's Comments on the ONC ISA 2024 Reference Edition

Please see attached the American Medical Informatics Association's feedback on the 2024 ISA Reference Edition. Thank you for the opportunity to comment.

 

AMIA-ONC-ISA-Public-Comment-Letter.pdf

AMIA's Comments on the ONC ISA 2024 Reference Edition

Please see attached the American Medical Informatics Association's feedback on the 2024 ISA Reference Edition. Thank you for the opportunity to comment.

AMIA-ONC-ISA-Public-Comment-Letter.pdf

HL7's Feedback on the 2024 ISA Reference Edition

Please see attached Health Level Seven International's feedback on the 2024 ISA Reference Edition. Thank you for the opportunity to comment.

HL7 Response ISA Letter 10.05.23 Final.pdf

APHL Comments on ISA 2022

APHL strongly supports the mission of the Interoperability Standards Advisory (ISA) and thus is respectfully submitting the following comments on the current version of the ISA

Vocabulary/Code Set/Terminology Standards and Implementation Specifications

General comment for this section:

In several sections the ISA lists implementation guides rather than linking to the explicit vocabulary defined in those guides (for example HL7 FHIR (v4.0.1) Situational Awareness for Novel Epidemic Response (SANER) IG 0.1.0 Continuous Build and the Logica COVID-19 (FHIR v4.0.1) Implementation Guide CI Build under COVID-19 Novel Coronavirus Pandemic , or in the referenced FHIR resources NutritionIntake  and NutritionProduct under Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation).

#1: Suggest to review and update with the respective code systems (or value sets, if appropriate to constrain to that level).

 

- Representing Non-imaging and Non-laboratory Clinical Tests:

Currently the section under “Limitations, Dependencies, and Preconditions for Consideration” includes a bullet explaining that this attribute really consists at minimum of 2 elements,

#1 Suggest to split attribute into “Clinical Test performed” and “Clinical Test Result Value” as a main section to avoid confusion when different code systems are suggested. That way it is clear that LOINC is the coding system to identify the “Clinical Test performed”, while SNOMED CT, mostly drawn from the clinical finding hierarchy, should be used when codifying results under “Clinical Test Result Value”. Other code systems useful in this context are Unified Units of Measure (UCUM) when numeric results are reported – this is described as its own attribute (Representing Units of Measure (For Use with Numerical References and Values), but the association to result values should be pointed out here.

 

- Laboratory

-- Representing Laboratory Test Ordered

This section is missing a separate category for Specimen, which should point to SNOMED CT (from the specimen hierarchy).

#1 Suggest to add a new attribute “Specimen information” which should have the following sub-attributes, some of which are mentioned in the USCDI:

Specimen Type – referencing SNOMED CT (from the specimen hierarchy)

Specimen source site – referencing SNOMED CT (from the body structure and physical object hierarchies)

Source site modifier – referencing SNOMED CT (from the qualifier hierarchy)

Specimen collection method – referencing SNOMED CT (from the procedure hierarchy)

 

The reference to CPT is confusing as the goal is to order lab tests using LOINC wherever possible (as further defined in the Laboratory Order Interface (LOI) Implementation Guide in the Ordering Laboratory Tests for a Patient section) and the use of CPT is uncommon in this use case.  CPT codes are commonly used for billing, which should be a separate section under laboratory to accommodate the administrative use case.

#2 Suggest to remove CPT from this section and create a separate section “Representing Laboratory Test in Billing” where CPT should be listed – with the same attributes as currently in this section.

 

Content/Structure

- Laboratory

-- Exchanging InVitro Diagnostics (IVD) Test Orders & Results

LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results :

#1 Suggest to remove the ‘$’ in the “Cost” column as there is no cost associated with accessing or using this implementation guide.

 

-- Ordering Laboratory Tests for a Patient

#1Suggest to update HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI) Release 1, STU Release 3 - US Realm to the latest version of LOI version (will provide updated name and hyperlink once published in October 2022)

#2 Suggest to update the HL7 Version 2 Implementation Guide: Laboratory Value Set Companion Guide Release 1, STU Release 3 - US Realm HL7 Standard for Trial Use to the latest version (will provide updated name and hyperlink once published in October 2022) in support of LOI

#3 Suggest to add this Implementation Guide from Jan 2021: HL7 Version 2.5.1 Implementation Guide: Standards & Interoperability (S&I) Framework Laboratory Test Compendium Framework (eDOS) Ask at Order Entry (AOE) Release 2, STU Release 3.1 - US Realm because it provides guidance on using the most common Ask at Order Entry questions; “Adoption Level” Emerging Standard. Of note is that this IG is not explicitly implemented, but rather used as a resource by laboratories when setting up their catalog and order messages.

 

-- Receive Electronic Laboratory Test Results

#1 Suggest to update HL7® Version 2.5.1 Implementation Guide: Lab Results Interface (LRI) Release 1, STU Release 3 - US Realm to the latest version of LOI version (will provide updated name and hyperlink once published in October 2022)

#2 Suggest to HL7® Version 2 Implementation Guide: Laboratory Value Set Companion Guide Release 1, STU Release 3 - US Realm, June 2018 to the latest version (will provide updated name and hyperlink once published in October 2022) in support of LRI

#3 Suggest to add the following text into “Limitations, Dependencies, and Preconditions for Consideration”: While the HL7® Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1—US Realm [HL7 Version 2.5.1: ORU_R01] Draft Standard for Trial Use, July 2012 was named in Meaningful Use and may thus be implemented at a few sites, the recommended standard for new implementations is <the new version of  HL7® Version 2.5.1 Implementation Guide: Lab Results Interface (LRI) Release 1, STU Release 3 - US Realm> because that is the specification that is actively being maintained and updated with new use cases, when needed.

 

-- Support the Transmission of a Laboratory’s Directory of Services to Provider’s Health IT or EHR System

#1 Suggest to HL7® Version 2 Implementation Guide: Laboratory Value Set Companion Guide Release 1, STU Release 3 - US Realm, June 2018 to the latest version (will provide updated name and hyperlink once published in October 2022) in support of eDOS

#2 Suggest to add HL7 Version 2.5.1 Implementation Guide: Standards & Interoperability (S&I) Framework Laboratory Test Compendium Framework (eDOS) Ask at Order Entry (AOE) Release 2, STU Release 3.1 (US Realm), because prior to this release this content was published as Appendix A in a single document as part of HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework (eDOS) Release 2, STU Release 3 (US Realm). In 2021, the AOE content was published separately for greater visibility and because it is standard agnostic, except for the data types which may be different for HL7 V2 vs. HL7 FHIR. There is an HL7 project (1634) to publish an update in the future to also reference FHIR datatypes.

 

-- Unique Device Identification

#1 Suggest to update HL7 Cross-Paradigm Implementation Guide: UDI Pattern, Release 1 to the latest release: HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2  for all sub-points in this section (Defining a Globally Unique Device Identifier, Representing Unique Implantable Device Identifiers and Transmitting a Unique Device Identifier); its adoption level should be increased since this is being used as building blocks for implementation of other IGs in certified systems across the US.

CAQH CORE Comments on the ONC ISA Annual Update

  • CAQH CORE appreciates the opportunity to provide content updates for the 2023 ISA Reference Edition and web version.
  • CAQH CORE has proposed several substantive updates including the addition of two new Operating Rule Sets supporting value-based payment and requirements to ensure secure and consistent connectivity between trading partners. Details surrounding these Operating Rules, including the language that is proposed for entry into the 2023 ISA Reference Edition and web version, are in the attached document on pages 4-5.
  • Non-substantive updates include edits to address consistency in naming conventions, the order that CAQH CORE Operating Rules appear on the web version of ISA and the 2023 ISA Reference Edition, and other grammar and syntax corrections. These changes are interspersed throughout the attached document highlighted in gray. Proposed deletions are highlighted gray and shown with strikethrough text.
  • Additional comments have been entered into the web version of the ISA for each CAQH CORE Operating Rule directing the reader to the pages in the attached document where changes have been made.

CAQH CORE ISA Letter 2022.pdf

ACLA ISA comment re: Annual Reference Edition

We appreciate the annual Reference Edition .pdf, but Is it also possible to get a revision marked version of the annual draft for comment and reference edition ISA in future? Narrowing the review to content that has changed will allow us greater focus on future comments.