Cancer Pathology Data Sharing, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cancer-reporting/ and changes regularly. See the Directory of published versions

Background

Relationship to NAACCR Volume V

This guide provides an alternative to the HL7 Version 2.5.1 message or HL7 CDA document approach. The following table illustrates the mapping of the well-established NAACCR segments to FHIR resources.

At present, patient and specimen data flow from the clinic and EHR to the pathology lab in a variety of formats, such as HL7 V2 and CDA. The NAACCR Standards for Cancer Registries Volume V, Laboratory Electronic Reporting Pathology Version 5.0, May 2020 (Revised 2020) defines a standard message format for transmitting pathology laboratory information to central cancer registries using the HL7 Version 2.5.1 Message format.

This IG provides an alternative to the HL7 V2 message for promoting better interoperability and scalability. This IG also addresses the collection and exchange of pathology lab data. That is, while discrete data elements are captured in electronic format in most laboratory information systems (LISs), typically, synoptic cancer pathology reports then flow from the LIS to EHRs in non-discrete data formats (e.g., pdf format). This IG helps address these issues.

This IG defines an electronic data exchange standard that maintains the discrete cancer pathology data when exchanging information among pathology laboratories, hospital systems, and registries for continuity of care, structured storage and exchange, standardized cancer reporting, and research. In addition, there is growing industry facilitation of FHIR standards for these kinds of use cases. For instance, starting in December 2022, CMS and ONC will require certified HIT vendors to implement FHIR-based APIs (see ONC’s Cure Act Final Rule). This IG is intended to assist pathology laboratory reporting in moving from V2 to FHIR alignment in accordance with these interoperability policy initiatives.

FHIR Profiles to Capture NAACCR Volume V

V2 Message Elements	NAACCRR Section	FHIR Artifact
Message Header segment (MSH)	2.6.1	US Pathology MessageHeader
Software Segment (SFT)	2.15.12	N/A
Patient Identification segment (PID)	2.6.2	US Core Patient Profile
Patient Visit segment (PV1)	2.6.2	US Core Encounter Profile, US Pathology-Related Practitioner, US Core Patient Profile
Common Order segment (ORC)	2.7.1	US Pathology-Related PractitionerRole
Observations Report ID segment (OBR)	2.7.2	US Pathology Diagnostic Report, US Pathology-Related Practitioner Role
Notes and Comments segment (NTE)	2.6.4	US Pathology Diagnostic Report
Observation/Result segment (OBX)	2.7.3	US Pathology Diagnostic Report results
Notes and Comments segment (NTE)	2.7.4	US Pathology Diagnostic Report
Specimen (SPM)	2.7.5	US Pathology Specimen
Observation Related to Specimen (OBX)	2.7.3	US Pathology Diagnostic Report
Continuation Pointer (DSC)

Relationship to IHE SDC on FHIR

The IHE Structured Data Capture (SDC) standard, IHE SDC eCP on FHIR, uses a form-driven workflow to capture and encode data and then create FHIR Observations from the captured data. The College of American Pathologists (CAP) has developed and tested the IHE SDC IG for collection of data from electronic Cancer Protocols (eCPs). The goal of IHE SDC eCP on FHIR is to extract data from these cancer checklists and create FHIR Observations for better interoperability between systems.

This Cancer Electronic Pathology Reporting FHIR IG and the IHE SDC eCP on FHIR are aligned and meant to operate together. Pathology data entered into an eCP by a pathologist can be converted into FHIR observations via the IHE SDC on FHIR IG. At that point, it can be transmitted to the Central Cancer Registry (CCR) either directly from the LIS or via an EHR intermediary. Both scenarios are described in this IG.

Relationship to MedMorph

The Cancer Pathology Data Sharing IG reporting process focuses on transmitting SDC/eCP on FHIR pathology resource bundles and distributing them via two pathways

1. LIS to CCR via an EHR
2. LIS to CCR directly

In the first scenario, this IG is designed to align with the MedMorph Reference Architecture (RA). The MedMorph RA now includes the Central Cancer Registry Reporting Content IG (CCRRC IG), which is a content IG supporting data exchange from ambulatory sources to CCRs for public health use. The LIS to CCR via an EHR exchange method leverages these existing MedMorph IGs to exchange data. EHRs reporting pathology data to these CCR registries via this pathway are expected to follow guidance provided in the CCRRC IG, including guidelines on PlanDefinition and Subscriptions. This alignment ensures cancer data from both ambulatory and pathology sources are exchanged via a common architecture.

The second scenario, LIS to CCR exchange, is also outlined in this IG with guidelines in the Artifact Index.

Figure: Data Flows Supported by this Implementation Guide

Ongoing Project Efforts

This project acknowledges the ongoing discussion about how LOINC vs. SNOMED terminologies serve cancer pathology, but it does not propose to resolve that discussion. Future development of this standard may explore new use cases, such as microbiology laboratory reporting. Future revisions will also include mappings for CAP eCC Protocol CKey Identifier to SNOMED translation.

Several cancer pathology exchange initiatives are underway internationally, including:

• Integrating Healthcare Enterprise (IHE) Pathology and Laboratory Medicine (PaLM) Technical Framework Supplement: Anatomic Pathology Structured Report (ASPR)
• PaLM ASPR application in Germany

Project Team

Cancer ePathology Reporting Project Contributors

Role	Name	Affiliation	Contact
Primary Editor	David deRoode	Lantana Consulting Group	david.deroode@lantanagroup.com
Primary Editor	Rick Geimer	Lantana Consulting Group	rick.geimer@lantanagroup.com
Co-Editor	Zabrina Gonzaga	Lantana Consulting Group	zabrina.gonzaga@lantanagroup.com
Co-Editor	Wendy Wise	Lantana Consulting Group	wendy.wise@lantanagroup.com
Co-Editor	Ruby Nash	Lantana Consulting Group	ruby.nash@lantanagroup.com
Co-Editor	Diana Wright	Lantana Consulting Group	diana.wright@lantanagroup.com
Co-Editor	Max Nakamura	Lantana Consulting Group	max.nakamura@lantanagroup.com
Subject Matter Expert	Wendy Blumenthal	Centers for Disease Control and Prevention (CDC)	wfb6@cdc.gov
Subject Matter Expert	David Jones	Centers for Disease Control and Prevention (CDC)	pvl1@cdc.gov
Subject Matter Expert	Sandy Jones	Centers for Disease Control and Prevention (CDC)	sft1@cdc.gov
Subject Matter Expert	Caitlin Kennedy	Centers for Disease Control and Prevention (CDC)	mhy5@cdc.gov
Subject Matter Expert	Temitope Alimi	Katmai Government Services contract to CDC	nyj4@cdc.gov
Subject Matter Expert	Wendy Scharber	Katmai Government Services/Registry Widgets contract to CDC	wendy@registrywidgets.com
Subject Matter Expert	Richard (Rich) Moldwin	College of American Pathologists	rmoldwi@cap.org
Subject Matter Expert	Alex Goel	College of American Pathologists	agoel@cap.org
Subject Matter Expert	Walter (Scott) Campbell	University of Nebraska Medical Center	wcampbel@unmc.edu

Current Work Group includes those who participated in the Cancer FHIR IG project: Hans Buitendijk, David Burgess, Lorraine Constable, Robert Hausam, Ralf Herzog, Patrick Loyd, Ulrike (Riki) Merrick, John David Nolen, James Alexander (Alex) Mays, Andrea Pitkus, Craig Newman, James Tcheng, Laura Heermann, and Calvin Beebe.