Introduction
This Implementation Guide helps enable interoperable laboratory data exchange between participating health institutions and registries with FHIR. Although we hope our work serves as the basis for broad-based lab data exchange, our initial clinical domain for this work is focused on oncology.
Development of this guide is taking place under a coorperative agreement with FDA, RTI International, Intermountain Healthcare (IHC), and CancerLinQ (CLQ). We are working together 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. These inputs are summarized in the Use Case section. They are also informing our Design Considerations.
Overall, this Implementation Guide is designed with the idea of using pre-harmonized LOINC-coded tests to identify certain kinds of laboratory test types. Our approach is consistent with the goals of the multi-stakeholder Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) collaborative.
Laboratory tests of interest
This project focuses on a core subset of key laboratory tests of importance in oncology. Specifically, we include the laboratory tests specified in mCODE and those made available in the CancerLinq Discovery platform.
The mCODE specification describes a key set of tumor marker tests relevant for oncology, and CLQ Discovery includes data made available to the research community and other stakeholders.
SARS-CoV-2 (COVID-19)
In addition to the mCODE and CLQ Discovery test types, we are actively working to incorporate diagnostic testing related to SARS-CoV-2 as well. This is an emerging area of development. We will seek to incorporate the testing performed at participating clinical sites in accordance with the coding guidelines outlined in the LIVD specification for SARS-CoV-2 tests maintained by the CDC.
Summary of laboratory test types
The table below shows the laboratory test types included in our present scope:
| Laboratory Test Type | mCODE | CLQ Discovery | Special |
|---|---|---|---|
| 5-Hydroxyindoleacetate | ☑ | ||
| Alpha-1-Fetoprotein | ☑ | ||
| Beta-2-Microglobulin | ☑ | ||
| Cancer Ag 125 | ☑ | ||
| Cancer Ag 15-3 | ☑ | ||
| Cancer Ag 19-9 | ☑ | ||
| Cancer Ag 27-29 | ☑ | ||
| Carcinoembryonic Ag | ☑ | ☑ | |
| Estrogen receptor | ☑ | ☑ | |
| HER2 | ☑ | ☑ | |
| Programmed cell death-ligand 1 (PD-L1) | ☑ | ||
| Progesterone receptor | ☑ | ☑ | |
| Prostate specific Ag | ☑ | ☑ | |
| Complete Blood Count | ☑ | ||
| Comprehensive Metabolic Panel | ☑ | ||
| Glomerular Filtration Rate | ☑ | ||
| Gleason Score | ☑ | ||
| Mean Platelet Volume | ☑ | ||
| Creatinine Clearance | ☑ | ||
| Prothrombin Time | ☑ | ||
| Lactate Dehydrogenase | ☑ | ||
| Magnesium | ☑ | ||
| Vitamin B12 | ☑ | ||
| O2 Saturation | ☑ | ||
| SARS-CoV-2 (COVID-19) | ☑ |
Role of this Implementation Guide
For each laboratory test in the core set, the IG contains more specific modeling constraints for agreement on the LOINC test terms, UCUM units of measure, etc.
We are building on the great work of several prior initiatives, including:
- U.S. Core Implementation Guide
- mCODE
- Womens Health Technology Coordinated Registry Network Implementation Guide
- HL7 FHIR Implementation Guide: Breast Cancer Data
Acknowledgements
This project is supported by grant # 1U01FD006933-01 from the U.S. Food and Drug Administration.
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