| Submitted By: Brian Bialecki / American College of Radiology | |
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| Data Element Information | |
| Rationale for Separate Consideration | The current USCDI v2 Data Element, Diagnostic Imaging Test does not convey the hierarchy established in Diagnostic Imaging. The Order/Imaging Service Request generates one or more Requested Procedures. See more info in Data Element Description |
| Use Case Description(s) | |
| Use Case Description | The typical case involves a radiology procedure being ordered, scheduled and performed for a registered patient. The administrative steps involve a patient being registered, a Diagnostic Imaging Order being placed for the registered patient, a unique Accession Number assigned, and the order being scheduled as a Requested Procedure. The procedure is then performed, with DICOM Images produced and archived in the PACS or VNA, and with status messages communicated to the EHR, VNA and other interested systems. Upon receipt of completion and availability status messages, images are interpreted by a physician (e.g., a radiologist) who dictates a Diagnostic Imaging Report. The system responsible for generating the report generates DICOM Image References in the CDA that may be used by the ordering physician or patient to access the DICOM Images in the PACS or VNA. This use case covers both inpatient and outpatient procedures. The patient may be new or known to the current healthcare facility. |
| Estimated number of stakeholders capturing, accessing using or exchanging | Diagnostic Imaging scheduled workflow is universal and well-adopted. More than 4,000 hospitals and 1 million providers are or are likely to be capturing, accessing, and exchanging Diagnostic Imaging orders and reports. Standardizing these terms in USCDI v4 would further improve health information exchange between hospitals, providers, and patients across all communities. According to the ISO 21860:2020 product adoption and site deployment IHE Scheduled Workflow is “Moderate”. This usage is consistent with USCDI Level 2 descriptor, “elements pertain to most or all patients, providers, or requestors.” |
| Link to use case project page | https://www.ihe.net/uploadedFiles/Documents/Radiology/IHE_RAD_TF_Vol1.pdf |
| Use Case Description | Additional links to support use case. See 34.4.2.1 IHE Scheduled Workflow Simple Use Case https://www.ihe.net/uploadedFiles/Documents/Radiology/IHE_RAD_TF_Vol1.pdf HL7 Standard for CDA Imaging Integration http://www.hl7.org/implement/standards/product_brief.cfm?product_id=13 FHIR ImagingStudy https://www.hl7.org/fhir/imagingstudy.html DICOMWeb https://www.dicomstandard.org/dicomweb/ US Core Data Interoperability Task Force 2021 https://www.healthit.gov/hitac/events/us-core-data-interoperability-task-force-2021-27 |
| Estimated number of stakeholders capturing, accessing using or exchanging | Diagnostic Imaging scheduled workflow is universal and well-adopted. More than 4,000 hospitals and 1 million providers are or are likely to be capturing, accessing, and exchanging Diagnostic Imaging orders and reports. Standardizing these terms in USCDI v4 would further improve health information exchange between hospitals, providers, and patients across all communities. According to the ISO 21860:2020 product adoption and site deployment IHE Scheduled Workflow is “Moderate”. This usage is consistent with USCDI Level 2 descriptor, “elements pertain to most or all patients, providers, or requestors.” |
| Healthcare Aims |
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| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | LOINC/RSNA Radiology Playbook includes Diagnostic Imaging Procedure Codes and Descriptions. HL7 Standard for CDA® Release 2: Imaging Integration; Basic Imaging Reports in CDA and DICOM Release 1 references LOINC® Document Type Codes, SNOMED CT® Quantity Measurement Type Codes, as well as DICOM Code Systems. FHIR ImagingStudy references SNOMED CT Body Structures https://loinc.org/oids/1.3.6.1.4.1.12009.10.2.5.1/ |
| Additional Specifications | Interactive Multimedia Report (IMR) Profile https://profiles.ihe.net/RAD/IMR/index.html |
| Current Use | This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
| Supporting Artifacts |
ISO 21860:2020 https://www.iso.org/standard/72004.html |
| Number of organizations/individuals with which this data element has been electronically exchanged | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
Starting in 2009, under a contract funded by the National Institute of Biomedical Imaging and Bioengineering, RSNA oversaw the creation of the Image Share Network, which enabled participating radiology sites to share imaging records with patients via secure online accounts. To promote adoption of the standards used in the Image Share Network, RSNA partnered with the Sequoia Project, an independent nonprofit dedicated to promoting health information exchange, to develop the RSNA Image Share Validation Testing Program. Many vendors have created private networks to share this data including PowerShare https://www.nuance.com/healthcare/diagnostics-solutions/radiology-network/powershare-medical-image-sharing.html https://www.rsna.org/practice-tools/data-tools-and-standards/image-share-validation-program |
| Potential Challenges | |
| Restrictions on Standardization (e.g. proprietary code) | None |
| Restrictions on Use (e.g. licensing, user fees) | HL7 FHIR is licensed under Creative Commons "No Rights Reserved". SNOMED is licensed. However, it is a current requirement of the USCDI. DICOM is copyrighted by National Electrical Manufacturers Association, IHE Scheduled Workflow is copyrighted by IHE International. Both organizations extend an irrevocable, worldwide, perpetual, royalty-free, nontransferable, nonexclusive, non-sublicensable license for the use of their respective standards and associated publications. |
| Privacy and Security Concerns | Security is addressed within the DICOM Standard Parts 15 and 18. IHE profiles also include security considerations. |
| Estimate of Overall Burden | We believe these data elements represent important additions over previous USCDI version, posing low-to-modest technical effort for EHR developers based on the maturity level of the standards referenced above. These data elements require minimal effort to develop an implementation guide. The underlying standards are mature and IHE profiles include use cases and transactions needed to develop implementation guides for certified APIs. These data elements also pose minimal burdern to the development of health IT modules as demonstrated by the testing of the FHIR ImagingStudy resourse in FHIR connectathon events. Since these data elements have already been universally adopted, they create no implementation burden on providers and health systems. |
| Other Implementation Challenges | None |
| ONC Evaluation Details Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI |
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| Maturity – Standards/Technical Specifications | Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification |
| Maturity - Current Use | Level 2 - Used at scale in more than 2 different production environments |
| Maturity - Current Exchange | Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Level 2 - Used by a majority of patients, providers or events requiring its use |
| Evaluation Comment | Thank you for your submission. |
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