# Data migration, validation and implementation of a new laboratory information system (LIS) in an academic pathology department, using Ellkay data archive, and Epic Beaker anatomic and clinical pathology modules

**Authors:** Jeffrey Benitez, Adam An, Alec B. Santos, Amelia Flaus, Matt Wawrzyszko, Beverley Young, Eleanor Latta, Catherine J. Streutker, Ju-Yoon Yoon

PMC · DOI: 10.1016/j.jpi.2025.100459 · Journal of Pathology Informatics · 2025-06-25

## TL;DR

This paper describes the challenges and validation process of switching to a new LIS and EMR system in a pathology department.

## Contribution

The paper introduces a systematic validation framework and a comprehensive handbook for LIS workflow implementation.

## Key findings

- SOP adaptations for Epic Beaker reproduced over 99% of previous workflows.
- Validation was limited to LIS functionality, with post-go-live issues found upstream.
- A phased approach with dry-lab testing improved workflow simulation and risk mitigation.

## Abstract

Implementation of a new laboratory information system (LIS) poses a significant challenge, amplified when synchronous with launch of a new electronic medical record (EMR) system. Our institution made an executive decision to switch to Epic EMR and Epic Beaker LIS from Cerner Soarian/Altera Sunrise EMR and Cemer CoPath Plus LIS in anatomic pathology and molecular genetic pathology, with a simultaneous go-live date. This synchronous migration required a complete overhaul in our department of laboratory medicine, impacting all standard operating procedures (SOPs). In our efforts to minimize potential risks, we pursued a phased approach to comprehensive validation, starting with iterative rounds of optimization, ending with the final round of validation assessing 45 consecutive pathology cases, simulating the entire workflow in a dry-lab setting, from ordering to reporting, including addenda, with additional cases tested for specific workflow steps. In addition, we pursued validation of result component migration, in form of legacy pathology results to the Epic EMR, and the Ellkay archiving system. We found that our SOP adaptations for Epic Beaker reproduced >99% of the workflows previously established using CoPath Plus. The validation performed was limited to Epic Beaker LIS functionality, and, post-go-live, deficiencies were uncovered largely upstream of the LIS. Based on our experience, we formed a framework for systematic validation of LIS workflows, and share our comprehensive handbook, detailing all workflows built before go-live.

## Full-text entities

- **Genes:** MGMT (O-6-methylguanine-DNA methyltransferase) [NCBI Gene 4255], ERBB2 (erb-b2 receptor tyrosine kinase 2) [NCBI Gene 2064] {aka CD340, HER-2, HER-2/neu, HER2, MLN 19, MLN-19}, CD274 (CD274 molecule) [NCBI Gene 29126] {aka ADMIO5, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1}
- **Diseases:** AP (MESH:D020763), lymphoma (MESH:D008223), LIS (MESH:D007757), Deficiencies (MESH:D007153), CP (MESH:D002972), cancer (MESH:D009369), ACE (OMIM:300909)
- **Chemicals:** paraffin (MESH:D010232), H&amp;E (MESH:D006371), PA (MESH:D011478), formalin (MESH:D005557)
- **Species:** Homo sapiens (human, species) [taxon 9606]
- **Cell lines:** HL7 — Paralichthys olivaceus (Bastard halibut), Transformed cell line (CVCL_B6DW)

## Full text

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## Figures

4 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12332207/full.md

## References

22 references — full list in the complete paper: https://tomesphere.com/paper/PMC12332207/full.md

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Source: https://tomesphere.com/paper/PMC12332207