Radiation Dose Summary for Diagnostic Procedures on FHIR, published by HL7 Imaging Integration Working Group. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/HL7/fhir-radiation-dose-summary-ig/ and changes regularly. See the Directory of published versions
This chapter describes the scope of this guide, provides background information about the radiation dose summary IG, key concepts, and describes the use cases supported by this implementation guide.
The IHE Dose Reporter actor from the IHE REM profile gathers Radiation information and dose reports from modalities. However, there is no standardization of the exposure of the gathered data to third parties in a light API based format.
Dose Management systems need to share information related to the exam to multiple third parties:
The RDSRs have a complete and a strong structure for sharing the dose information from the modalities to the Dose Consumer/Reporter actors, and also between the Dose Reporter and the Dose Registry systems. However, most of third party applications have a very light needs for the Dose report. For example, RIS systems in France need only, for CT exams, the Dose Length Product Total data from the CT RDSR, in order to fit local regulations.
The emergence of HL7 FHIR simplified the exchange between backend applications and third parties through the exchange of normalized resources having stable structures. This analysis allows to share minimal dose information through FHIR resources.
Scope:
Out Of Scope:
Dealing with sharing details of radiation procedures, like the X-Ray parameters, the modality configuration, etc., is out of scope. Also, sharing the details of enhanced dose data, like the size specific dose estimation, is also out of scope. Other means exist to share this detailed information, mainly the DICOM Radiation Structured Reports (RDSRs).
The defined profiles in this IG are describing radiation information within a unique irradiation act, which may contain multiple irradiation events. Calculating patient cumulative radiation over a period of time, and/or through multiple procedures and modalities, is out of scope, even if the current IG simplifies such computations. In parallel, the interpretation of radiation information is out of scope; this depends on facilities workflows, may be subject of interpretations, and may vary following regulations.
Radiotherapy procedures are not covered by the scope of this work, only diagnostic imaging radiations is covered by this work.
The FHIR profiles defined in this IG are engineering solution in order to simplify sharing the radiation summary information between heterogenous applications. This implementation guide is not meant to describe how the Radiation Data is treated, and who can access and interpret the radiation information. These details are site specific and follow the international and national regulations and recommendations; also, they follows facilities culture and workflows. For instance, facilities should follow recommendations from the AAPM/ACR/HPS Joint Statement on Proper Use of Radiation Dose Metric Tracking for Patients Undergoing Medical Imaging Exams; patient radiation history should not be used for decision making prior to exams.
The main use case identified for this implementation guide is the following:
This use case is very common within RIS systems not supporting dose management modules. In fact, gathering of dose information from modalities can be very complex:
It is the role of the Dose management system to provide the RIS with the right information regarding the dose administered to the patients. Reporting the minimal dose information inside the final imaging report is recommended by many stakeholders and organizations, and sometimes it is a regulation. For example, in France there are the Order of 22 September 2006 relating to the radiation information to be included in an act report using ionizing radiation, from the French Minister of Health and Solidarity, and describing some dose information that needs to be present in the final report.
The same kind of regulations exists in California in the US about the CT exams, which is the Senate Bill No. 1237.
In this paragraph, we analyze the mapping between the identified minimal dose information and some specifications on dose information reporting coming from multiple stakeholders:
The analysis of the different specifications allowed to obtain the following coverage between the minimal dose information and these specifications/guidelines:
Dose Information |
Modality |
|
PS3.20 |
PS3.16 |
|
Finland |
France |
USA
|
|||||||
CT |
XA |
RF |
MG |
NM |
|
CT RDSR |
X-Ray RDSR |
RRDSR |
TID 2008 |
|
|||||
Irradiation authorizing Person |
|
|
|
|
|
|
Y |
|
|
|
Y |
|
|
Y |
Y |
Pregnancy Observation |
|
|
|
|
|
|
Y |
|
|
|
Y |
|
|
Y |
Y |
Indication Observation |
|
|
|
|
|
|
Y |
|
|
|
Y |
|
|
Y |
|
Device |
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|
|
|
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Y |
Y |
Y |
|
|
|
Y |
Y |
Irradiation Issued Date |
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|
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|
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|
|
Y |
Y |
Y |
|
|
|
Y |
Y |
Associated Procedure |
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|
|
|
|
|
|
Y |
Y |
Y |
|
|
|
Y |
|
Dose measurements - Study level |
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Dose (RP) Total |
|
Y |
Y |
Y |
|
|
Y |
|
Y |
|
|
|
Y |
|
|
Accumulated Average Glandular Dose |
|
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|
Y |
|
|
Y |
|
Y |
|
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|
Y |
|
Dose Area Product Total |
|
Y |
Y |
Y |
|
|
Y |
|
Y |
|
|
|
Y |
Y |
|
Fluoro Dose Area Product Total |
|
Y |
Y |
Y |
|
|
Y |
|
Y |
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|
Acquisition Dose Area Product Total |
|
Y |
Y |
Y |
|
|
Y |
|
Y |
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|
|
Total Fluoro Time |
|
Y |
Y |
Y |
|
|
Y |
|
Y |
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|
|
Total Number of Radiographic Frames |
|
Y |
Y |
Y |
|
|
Y |
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|
CT Dose Length Product Total |
Y |
|
|
|
|
|
Y |
Y |
|
|
|
|
Y |
Y |
Y |
Administered activity |
|
|
|
|
Y |
|
Y |
|
|
Y |
|
|
|
Y |
|
Radiopharmaceutical Agent |
|
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|
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Y |
|
Y |
|
|
Y |
Y |
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|
Y |
|
Radionuclide |
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Y |
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Y |
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|
Y |
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Radiopharmaceutical Volume |
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Y |
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Y |
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Route of administration |
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|
Y |
|
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|
Y |
|
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|
Y |
|
Dose measurements - Irradiation Event level |
|
|
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|
|
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|
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|
|
|
|
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Mean CTDIvol |
Y |
|
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Y |
Y |
|
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|
Y |
|
Y |
DLP |
Y |
|
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|
Y |
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|
|
Y |
Target Region |
Y |
|
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|
Y |
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|
Y |
Y |
CTDIw Phantom Type |
Y |
|
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|
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|
Y |
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|
Y |
The identified minimal dose information that should be collected by the dose management system and shared with third parties applications are divided into contextual information data and dose measurements data.
Contextual Information data:
Contextual Information | Identifier | Level |
---|---|---|
Irradiation Authorizing Person | EV (113850, DCM, Irradiation Authorizing) | Procedure |
Pregnancy Observation | EV (82810-3, LN, Pregnancy status) | Procedure |
Indication Observation | EV (18785-6, LN, Indications for Procedure) | Procedure |
Irradiating Device | EV (113859, DCM, Irradiating Device) | Procedure |
Irradiation Issued Date | EV (113809, DCM, Start of X-Ray Irradiation) | Procedure |
Related Imaging Study | EV (110180, DCM, Study Instance UID) | Procedure |
Dose measurements data:
Dose Measurements | Identifier | DICOM TID | Level | Type | Unit/ValueSet |
---|---|---|---|---|---|
Dose (RP) Total | EV (113725, DCM, Dose (RP) Total) | TID 10007 | Procedure | Quantity | mGy |
Accumulated Average Glandular Dose | EV (111637, DCM, Accumulated Average Glandular Dose) | TID 10005 | Procedure | Quantity | mGy |
Dose Area Product Total | EV (113722, DCM, Dose Area Product Total) | TID 10007 | Procedure | Quantity | mGy.cm2 |
Fluoro Dose Area Product Total | EV (113726, DCM, Fluoro Dose Area Product Total) | TID 10004 | Procedure | Quantity | mGy.cm2 |
Acquisition Dose Area Product Total | EV (113727, DCM, Acquisition Dose Area Product Total) | TID 10004 | Procedure | Quantity | mGy.cm2 |
Total Fluoro Time | EV (113730, DCM, Total Fluoro Time) | TID 10004 | Procedure | Quantity | s |
Total Number of Radiographic Frames | EV (113731, DCM, Total Number of Radiographic Frames) | TID 10007 | Procedure | Integer | |
CT Dose Length Product Total | EV (113813, DCM, CT Dose Length Product Total) | TID 10012 | Procedure | Quantity | mGy.cm |
Administered activity | EV (113507, DCM, Administered activity) | TID 10022 | Administration | Quantity | MBq |
Radiopharmaceutical Agent | EV (349358000, SCT, Radiopharmaceutical agent) | TID 10022 | Administration | CodeableConcept | Radiopharmaceuticals Value Set |
Radionuclide | EV (89457008, SCT, Radionuclide) | TID 10022 | Administration | CodeableConcept | Isotopes Value Set |
Radiopharmaceutical Volume | EV (123005, DCM, Radiopharmaceutical Volume) | TID 10022 | Administration | Quantity | cm3 |
Route of administration | EV (410675002, SCT, Route of administration) | TID 10022 | Administration | CodeableConcept | Route of Administration |
Mean CTDIvol | EV (113830, DCM, Mean CTDIvol) | TID 10013 | Irradiation Event | Quantity | mGy |
DLP | EV (113838, DCM, DLP) | TID 10013 | Irradiation Event | Quantity | mGy.cm |
Target Region | EV (123014, DCM, Target Region) | TID 10013 | Irradiation Event | CodeableConcept | Anatomy Imaged |
CTDIw Phantom Type | EV (113835, DCM, CTDIw Phantom Type) | TID 10013 | Irradiation Event | CodeableConcept | Phantom Devices |
Remarks:
This IG is based on HL7 FHIR standard, as well as DICOM standard, and its packaged value sets fhir.dicom. This IG uses also a profile from the specification International Patient Summary IG (IPS). Implementers of this specification must understand some basic information about the underlying specifications listed above.
This IG uses terminology, notations and design principles that are specific to the HL7 FHIR standard. Before reading the page architecture and implementation, it is important to be familiar with the basic principles of FHIR and how to read FHIR specifications. Readers who are unfamiliar with FHIR are encouraged to review the following prior to reading the rest of this implementation guide.
This implementation guide supports the recently published FHIR R4 version of the FHIR standard to ensure alignment with the current direction of the FHIR standard.
The table below identifies the specific FHIR Resources and their purposes that will be used in this IG. Implementers should familiarize themselves with these FHIR resources and their purposes.
FHIR Resource | Purpose |
---|---|
Observation | Used to describe the radiation dose summary and the collected minimal dose information |
Patient | Used to reference the irradiated person |
Practitioner | Used to reference the related irradiation authorizing person |
Device | Used to describe the irradiating modality |
ImagingStudy | Used to reference the performed exam |
Composition | Used to create the irradiation report |
DICOM® is used as reference standard, as it provides a complete definition of the dose information that can be present in a radiation report. The DICOM® version used in this IG is the 2021d release. The packaged value sets coming from DICOM within fhir.dicom are referenced many times in the different profiles of this IG.
Pregnancy Status Profile from International Patient Summary IG (IPS) is used within our IG ion order to report possible pregnancy of irradiated person.
International Patient Summary IG (IPS)
The following terms and initialisms/acronyms are used within the Radiation Dose Summary IG:
Term | Definition |
---|---|
AAPM | American Association of Physicists in Medicine |
ACR | American College of Radiology |
ATNA | Audit Trail and Node Authentication |
CDA | Clinical Document Architecture |
CDS | Clinical Decision Support |
CT | Computed Tomography |
CTDI | Computed Tomography Dose Index |
DAP | Dose Area Product |
DICOM | Digital Imaging and Communications in Medicine |
DLP | Dose Length Product |
EHR | Electronic Health Record |
EMR | Electronic Medical Record |
FHIR | Fast Healthcare Interoperability Resources |
HAS | French High Authority of Health |
HL7 | Health Level Seven |
HPS | Health Physics Society |
IEC | International Electrotechnical Commission |
IG | Implementation Guide |
IHE | Integrating the Healthcare Enterprise |
IOD | Information Object Definition |
IPS | International Patient Summary |
MG | Mammography |
MPPS | Modality Performed Procedure Step |
NM | Nuclear Medicine |
OCR | Optical Character Recognition |
PHI | Personal Health Information |
RDSC | Radiation Dose Summary Consumer |
RDSP | Radiation Dose Summary Producer |
RDSR | Radiation Dose Structured Report |
REM | Radiation Exposure Monitoring |
REM-NM | Radiation Exposure Monitoring for Nuclear Medicine |
REST | Representational State Transfer |
RF | Radio Fluoroscopy |
RIS | Radiology Information System |
RP | Reference Point |
RRDSR | Radiopharmaceutical Radiation Dose Structured Report |
SFR | French Society of Radiology |
SR | Structured Report |
SSDE | Size Specific Dose Estimation |
TID | Template ID |
TLS | Transport Layer Security |
UID | Unique identifier |
URL | Uniform Resource Locator |
URN | Uniform Resource Name |
VR | Value Representation |
XA | X-Ray Angiography |
XDS-I.b | Cross-enterprise Document Sharing for Imaging |