IHE SDC/electronic Cancer Protocols (eCPs) on FHIR
1.0.0 - trial-use

IHE SDC/electronic Cancer Protocols (eCPs) on FHIR, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ihe-sdc-ecc-on-fhir/ and changes regularly. See the Directory of published versions

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Official URL: http://hl7.org/fhir/uv/ihe-sdc-ecc/ImplementationGuide/hl7.fhir.uv.ihe-sdc-ecc | Version: 1.0.0
Active as of 2024-12-06 | Computable Name: IHESDCeCCOnFHIR

Note: If you have come here looking for FHIR Structured Data Capture using Questionnaire go here: HL7 FHIR SDC Implementation Guide This implementation guide describes how to use Integrating the Healthcare Enterprise (IHE) Structured Data Capture (SDC) with FHIR. This guide was produced as a collaborative effort between the IHE Quality, Research, and Public Health (QRPH) and HL7.

### Introduction

This implementation guide will enable implementers to transmit electronic Cancer Protocols (eCPs) (formerly known as the electronic Cancer Checklists (eCCs)) data using FHIR resources, which are based on Integrating the Healthcare Enterprise (IHE) Structured Data Capture (SDC). IHE SDC/eCP on FHIR uses a form-driven workflow to capture and transmit encoded data by creating FHIR Observations.

The SDC initiative was established by The Office of the National Coordinator for Health Information Technology (ONC) in 2013 to develop two implementation guides:

- IHE SDC Technical Framework
- HL7 FHIR SDC Implementation Guide

On March 30, 2017 the ONC transitioned both initiatives into community led projects. Both initiatives focus on improving data capture within healthcare. The CAP selected IHE SDC for their collection of eCPs. This implementation guide will enable implementers to transmit eCP data in FHIR resources.

IHE SDC is deployed in a number of different use cases, beyond Pathology and in order to accomodate those additional use cases this IG is Universal Realm. It is expected that implementers may want to apply other standards such as US-Core to this IG in order to meet their needs. This IG is intended as guidance on how to map from the IHE SDC XML form model to FHIR. It should be noted that this guide does not make use of Questionnaire like FHIR SDC, but does follow the same data extraction pattern.

The encoded eCP/SDC xml may be included in the message as an encoded attachment data element or alternatively linked as a URL.

### FHIR Version

This FHIR implementation guide is based on FHIR R4.

### Purpose

This implementation guide specifies a pattern of use for IHE SDC with applicable FHIR resource to enable use of data captured from IHE SDC forms within FHIR. This guide supports:

- Creation of structured data in FHIR
- Use of that data

Leveraging IHE SDC and FHIR allows for data to be shared more easily and enables improved data management and analysis as well as pre-population of data in new forms. The coding of structured data automates the interpretation and utilization of the data thereby allowing for the automation of processes, and increasing efficiency and accuracy. The representation of data as a FHIR resource can remove barriers that exist between different datasets while improving interoperability and making data more useful to providers, hospitals, and cancer registries.

### The College of American Pathologists eCPs

The College of American Pathologists (CAP) Cancer Reporting Protocols offer a guideline for the collection of key data elements for reporting of malignant tumours. The protocols can be used in a number of different tumour types and procedures such as biopsies and resections. Protocols are made up of two parts: the case summary and the explanatory notes.

The case summary section contains core data elements and optional data elements. Core data elements are the mandatory elements which must be reported whether or not they are applicable to the case. A subset of the core elements are conditional data elements which are only completed if applicable to the case. Optional data elements are fields which may be required for reporting based on practice standards at local institutions or different jurisdictions. These elements are identified with a “+”.

The explanatory notes within the cancer protocols aim to provide guidance and support the accurate completion of the case summaries.

### Common use cases

Use cases for IHE SDC/eCP on FHIR include:

- Public health reporting (e.g. Cancer Registry reporting)
- Quality measurement and evaluation
- Clinical guideline concordance evaluation
- Auto-population of future forms

#### Public health reporting (e.g. Cancer Registry reporting)

In this use case the conversion of SDC forms to FHIR resources has the potential of enabling high-quality public health reporting through improved ease of data collection and transmission, and improved accuracy of data. Ultimately this can be used to better integrate with cancer registries for public health planning and reporting. The coding of data to a common standard helps to remove the discrepancies that may exist between different datasets which can allow registries to more easily compare and correlate data. This allows for public health decision-making that effectively combines different datasets, improves efficiency through automation, and limits errors through the removal of human interaction.

#### Quality measurement and evaluation

In this use case the conversion of SDC forms to FHIR resources could enable institutions to more easily collect data as it relates to pathology or radiology reporting through a common and standardized format. This would enable improved analysis of data which could then be used for quality measurement and evaluation activities at the facility or physician level. Based on the data collected institutions could introduce quality improvement initiatives or additional training opportunities for providers. Quality Measurement is not in scope for this implementation guide; implementers are expected to use this IG to facilitate data capture for Quality Measurement.

#### Clinical guideline concordance evaluation

In this use case the conversion of SDC forms to FHIR resources enables the evaluation of concordance against computable representations of narrative clinical guidelines. As new guidelines are introduced, specific measures can be identified as methods of assessing concordance to the guideline. Having SDC form data available in a standardized format enables the assessment of concordance against guidelines by hospitals or governing bodies.

#### Auto-population of future forms

In this use case information collected through SDC forms could be used to auto-populate future forms. Data collected as a FHIR resource can be linked to a patient record so that any future forms relating to that patient can be automatically pre-populated with existing relevant data. One example is a patient having a second biopsy, in which case all relevant data from the first biopsy can be automatically included in a report to the treating physician. This would improve efficiency, while reducing errors and ensuring that all relevant data is available to the care team.

### Scope

This implementation guide establishes a pattern for how to transport IHE SDC forms using FHIR DocumentReference, and DiagnosticReport, and how to extract data from IHE SDC forms to FHIR Resources, namely Observations.

### Audience

This implementation guide is intended for those form designers, systems developers and integrators, and clinical informaticists. The audiences for this implementation guide should consider how IHE SDC forms and data may be used within FHIR.

### SDC Form Structure

IHE SDC utilizes Identifiers on all Question and Answer Sets (QAS). These IDs within the QAS better allow for mapping between IHE SDC forms, standard or local terminology, billing codes, etc. They enable implementers to better capture and utilize their structured data within databases.

IHE SDC forms also have a robust metadata section that allows for the capture of important copyright information on the form, its disease site and other important information such as versioning. More detail on this can be found in the IHE SDC Technical Framework Supplement

The Data Extraction section of this IG describes how to convert each question type into an Observation. The patterns described here have been aligned with the HL7 FHIR SDC Implementation Guide: Form Data Extraction patterns, however further work is being conducted to enhance that alignment.

### Transport of the IHE SDC Forms within FHIR

A DocumentReference is the preferred way to transport an IHE SDC form as an attachment within FHIR. The Form SHALL be Base64 encoded and included for transport much like a CDA document or PDF might be. The IHE SDC/eCP on FHIR DocumentReference profile describes the constraints of sending an IHE SDC form using FHIR protocols.

#### Support of DocumentReference

It should be noted that DocumentReference is ideal for transmitting blank forms, but may also be used for filled forms in systems which do not support DiagnosticReport. Therefore an implementer may use a DocumentReference to capture the IHE SDC form and share it within FHIR with its filled data. Otherwise, the preference is for implementers to capture the data as described on the Data Extraction page using the IHE SDC/eCP on FHIR DiagnosticReport and the IHE SDC/eCP on FHIR Observation.

### Must Support

The elements labelled Must Support in this guide should be sent if available. If they are unavailable, refer to cardinality of the element. For implementers using these resources if the data is unavailable they do not need to include the element.

### Acknowledgements

This library of FHIR resources was developed and produced through the efforts of Health Level Seven (HL7). The editors appreciate the support of all volunteers and staff associated with the creation of this document and the sponsorship of the following Work Groups: Orders & Observations, and FHIR Infrastructure. This guide would not have been possible without the support of the following organizations:

- Centers for Disease Control and Prevention (CDC)
- North American Association of Central Cancer Registries (NAACCR)
- College of American Pathologists (CAP)

This material contains content from SNOMED CT®. SNOMED CT is a registered trademark of the International Health Terminology Standard Development Organization (IHTSDO).

This material contains content from the CAP. The Electronic Cancer Protocols are copyrighted by the CAP. All rights reserved.

### Dependencies

IG | Package | FHIR | Comment
--- | --- | --- | ---
IHE SDC/electronic Cancer Protocols (eCPs) on FHIR | hl7.fhir.uv.ihe-sdc-ecc#1.0.0 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#6.1.0 | R4 | Automatically added as a dependency - all IGs depend on HL7 Terminology
FHIR Extensions Pack | hl7.fhir.uv.extensions#5.2.0-ballot | R5 |
HL7 Terminology (THO) | hl7.terminology.r5#6.1.0 | R5 |

Package hl7.fhir.uv.extensions#5.2.0-ballot This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Thu, Dec 5, 2024 04:12+0000+00:00)

### Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.uv.ihe-sdc-ecc.r4) and R4B (hl7.fhir.uv.ihe-sdc-ecc.r4b) are available.

### Global Profiles

There are no Global profiles defined

### IP Statements

This publication includes IP covered under the following statements.

- Copyright by College of American Pathologists. All rights reserved.Licensing is required. Contact the CAP at capecc@cap.org for more information about licensing and using the CAP eCC for cancer reporting.
  Show Usage
  - College of American Pathologists (CAP) eCC (electronic Cancer Checklists): Observation/SDCeCCObservationChild, Observation/SDCeCCObservationCode... Show 4 more, Observation/SDCeCCObservationCodeLIR, Observation/SDCeCCObservationParent, Observation/SDCeCCObservationSection and Observation/SDCeCCObservationStringEx
- This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
  Show Usage
  - LOINC: DiagnosticReport/eCCDiagnosticReport0 and DocumentReference/eCCDocRef0
- This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
  Show Usage
  - identifierType: DiagnosticReport/eCCDiagnosticReport0, DocumentReference/eCCDocRef0, Observation/SDCeCCObservationCode, Observation/SDCeCCObservationCodeLIR and Observation/SDCeCCObservationStringEx