Cancer Pathology Data Sharing, published by HL7 Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). 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 cancer pathology reporting FHIR IG has been developed by Cancer ePathology Reporting Project in collaboration with the IHE SDC/eCC on FHIR Project, both under the Orders & Observations Working Group, and with other stakeholders. It provides an alternative to the HL7 Version 2.5.1 Message approach used by the NAACCR Standards for Cancer Registries Volume V for cancer pathology synoptic reports. The following table illustrates the mapping of the well-established NAACCR segments to FHIR resources.

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

There is a need for an electronic data exchange standard that maintains the discrete cancer data when exchanging information among pathology laboratories, hospital systems, and registries for continuity of care, cancer reporting, and research. In addition, starting in December 2022, CMS and ONC 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 that initiative.

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
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 eCC on FHIR, (under development) uses a form driven workflow to capture and encode data and then create FHIR Observations from the captured data. The College of American Pathologists has implemented IHE SDC for collection of electronic Cancer Checklists (eCCs). The goal of IHE SDC eCC on FHIR is to extract data from these cancer checklists and create FHIR Observations for interoperability between systems.

This Cancer Electronic Pathology Reporting FHIR IG and the future IHE SDC eCC on FHIR should complement each other. Pathology data entered into an eCC can be converted into FHIR via the IHE SDC on FHIR IG. From there, it can be transmitted from LIS to EHR or Central Cancer Registry (CCR) using this IG.

Relationship to MedMorph

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

1. LIS to EHR and on to a CCR
2. LIS to CCR

In the first scenario, this IG is designed to align with the MedMorph Reference Architecture. 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 reporting cancer data to regional, state, and territorial public health CCRs. EHRs reporting pathology data to these registries via this pathway are expected to follow guidance provided in that 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 and guidelines can be found in the Artifact Index.

Figure: Data Flows Supported by this Implementation Guide

Ongoing Project Efforts

This project acknowledges that there is an 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.

There are also several cancer pathology exchange initiatives 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.