Development of this guide is taking place under a cooperative agreement with FDA, RTI International, Intermountain Healthcare (IHC), and CancerLinQ (CLQ). We are working together in an incremental fashion to develop and test the exchange of laboratory data from electronic health records (EHR) to registries using FHIR.

We are gathering requirements and assessing the readiness of participating entities with user-centered design principles.

The guiding principles we've used to make decisions are documented in the Design Considerations.

A summary of the key data elements needed by registries for using lab test results are captured in Data Elements. This page also contains mappings from these data elements to the corresponding structure in FHIR (if available).

Because our core focus is on lab results, we have defined a profile that set minimum expectations for the Observation resource to search and fetch laboratory test results associated with a patient. This Guide identifies the core elements, extensions, vocabularies, and value sets that FHIR resources exchanged between EHRs and registries will use.

Exclusions from this Guide

The Observation resource contains data elements that are pointers (references) to other relevant FHIR resources, e.g. Patient, Encounter. Because our pilot focus is on the lab data itself (which is represented in the Observation), we have not further specified or included those resources in this Guide.

Likewise, Observations can be collected into containers like DiagnosticReport. Our registry users did not have present need for exchange of those containers, so they are also omitted from this Guide.