Currently, EHRs receive data from the pathology lab in an unstructured format limiting the ability to make meaningful decisions on the data and report data to the jurisdiction-based central cancer registries. The intent of this project is to use FHIR to establish electronic health data exchange of cancer pathology information between a hospital or facility-based laboratory information system (LIS) and hospital or facility-based electronic health record (EHR) system. The goal is to create a standard and develop a FHIR implementation guide (IG) to exchange pathology data captured by pathologists using the College of American Pathology (CAP) electronic Cancer Checklist (eCC) Protocols into the EHR in a discrete, coded format. Creating a standard should lead to more accurate and complete reporting of information from EHRs to jurisdiction-based central cancer registries. This project acknowledges that there is an ongoing discussion about how LOINC vs. SNOMED terminologies serve Cancer pathology, but does not propose to resolve any discussion between them.
The scope of the first version of this IG will focus on the data elements in the eCC Protocols required for reporting the 6 most common types of cancers
• Breast: Protocol for the Examination of Resection Specimens from Patients With Invasive Carcinoma of the Breast. Version: Breast Invasive Resection 4.4.0.0 Protocol Posting Date: February 2020
• Lung:
o Protocol for the Examination of Resection Specimens from Patients with Primary Non-Small Cell Carcinoma, Small Cell Carcinoma, or Carcinoid Tumor of the Lung. Version: Lung 4.1.0.1 Protocol Posting Date: February 2020.
o Template for Reporting Results of Biomarker Testing of Specimens from Patients with Non-Small Cell Carcinoma of the Lung. Version: Lung biomarker 1.3.0.2 Protocol Posting Date: June 2016, revised August 2018
• Colon and Rectum:
o Protocol for the Examination of Resection Specimens from Patients with Primary Carcinoma of the Colon and Rectum. Version: Colon and Rectum Resection 4.1.0.0 Protocol Posting Date: February 2020
o Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Colon and Rectum. Version Colon Biomarkers 1.2.0.1 Template web posting date: December 2014, revised August 2018
• Prostate: Protocol for the Examination of Radical Prostatectomy Specimens from Patients with Carcinoma of the Prostate Gland Version: Prostate Radical Prostatectomy 4.1.0.1 Protocol Posting Date: March 2020
• Skin:
o Protocol for the Examination of Excision Specimens from Patients with Melanoma of the Skin. Version 4.2.0.0 Protocol Posting Date: April 2020
o Template for Reporting Results of Biomarker Testing of Specimens from Patients with Melanoma. Template posting date: July 2015.
• Central Nervous System: Protocol for the Examination of Specimens from Patients with Tumors of the Central Nervous System. Version: CNS 4.0.0.0 Protocol Posting Date: August 2018
The project team has started initial requirements gathering and has reviewed existing standards such as NAACCR Electronic Reporting Volume 5 v.4.0 , HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment 2) , Structured Data Capture and HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1 . The project team continues to meet and explore work done by similar workgroups and project teams to discuss potential for alignment and reduce redundancies. Analysis includes a review of existing data elements and value sets and identification of potential new value sets and/or codes needed to implement this IG.
This project team has reached out to IHE SDC (Alex Goel) to discuss the differences and how to tightly couple the scope of this project with their IHE SDC FHIR Project. The IHE SDC FHIR project will focus on specifying an overarching architecture for the transformation of IHE SDC question and answer observations to FHIR observations. This project will focus primarily on specifying how content in an eCC protocol which is set up in a question and answer pair, is mapped to FHIR using mCode and FHIR R4 as the starting point for the design. The content in this project will focus on mapping a subset of data in the 6 eCC protocols mentioned above that are required for reporting to cancer registries. Since the IHE SDC FHIR architecture is not limited to a data set, the content in this IG could be referenced as an example in the IHE SDC FHIR IG. Please see the IHE SDC on FHIR Project Proposal IHE SDC on FHIR Project Proposal (
https://jira.hl7.org/browse/PSS-1683).
This team has also reached out to the mCode team (May Terry) to keep abreast of planned changes to mCode. Since mCode is planning to pursue a STU2 May 2021 ballot, this project team plans to work closely with the mCode team during development to communicate any recommendations for changes that may apply to other use cases outside of this IG.
As part of socializing this project proposal, we welcome additional input for collaboration and solicitation of interest.
References:
NAACCR Standard for Cancer Registries Volume V; Pathology Laboratory Electronic Reporting V4.0.
https://www.naaccr.org/wp-content/uploads/2016/11/Pathology-Laboratory-Electronic-Reporting-Version-4.0-April-2011.pdf
FHIR Breast Cancer IG.
http://hl7.org/fhir/us/breastcancer/2018Sep/
FHIR SDC STU 3:
http://hl7.org/fhir/uv/sdc/2019May/
FHIR mCode IG:
http://hl7.org/fhir/us/mcode/