Academy of Diagnostics & Laboratory Medicine - Scientific Short
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Clinical laboratories are under significant pressure to introduce new technologies with steady-state staffing. Besides new automation lines and automated analyzers, one of the most labor-intensive projects that confronts the laboratories is the implementation of new laboratory information systems (LIS). Although the LIS used to be a standalone system, an increasing number of laboratories are transitioning to LISs that are integrated into the electronic health record (EHR), often driven by cost-containment mandates. The project scope becomes even more daunting when the LIS implementation is concurrent with the EHR rollout, especially in integrated delivery networks.
LIS implementation is a balancing act: the build, validation, and testing of the new system must be performed in parallel to the continuous provision of high-quality laboratory services. With stringent timeline requirements, laboratories are challenged to make informed decisions about project scope, such as instrument interfacing and rule development1, EHR-to-EHR interfaces2, susceptibility test reporting, and decision trees for organism identification in microbiology2. Another key consideration is whether current workflows (pre-analytical, analytical, and post-analytical) can be reproduced or retrofitted into the new systems1–5.If workflow remapping is indicated, change management is helpful when specific tasks are reassigned to a different team.
Scope determination is followed by three phases that require extensive build/re-build activities: the build and validation/testing phases prior to go-live and the optimization phase after go-live1–5. In reality, the first two phases are usually intertwined due to the iterative nature of the build-test-fix cycle. As staff become familiar with the new system, testing may reveal helpful functionality that needs to be built but is not explicitly included in the project plan. Prioritization, although challenging, necessitates multidisciplinary alignment, as a different resource allocation paradigm will be implemented during optimization to address more acute, stabilization-related needs rather than new builds. One viable approach is to prioritize requests directly impacting patient safety (e.g., blood product administration) over projects primarily geared toward operational efficiency. Mitigation strategies need to be developed if certain valuable but deemed “nice-to-have” functionalities are inaccessible at go-live.
Key areas of LIS build that require extensive testing are described in laboratory accreditation checklists and practice guidelines, such as auto-verification, calculations, critical values, and reference intervals. Peer experience often serves as a great starting point for discussions with analysts to provide build ideas and level-set expectations (e.g., free testosterone6, kidney failure risk equation7). Since it may not be possible to access the production environment during testing, post-go-live testing is instrumental to ensure the integrity of the build migration and that workflows function as intended. In addition to the test compendium and restrictor settings that control test orderability to manage utilization, another area that requires special attention for testing is billing, such as the accuracy of CPT codes for panels, the split of technical charges if specimen processing and immunohistochemistry are performed across sites within the hospital network, and pre-authorization of send-out tests. The build-testing phase also presents a unique opportunity in health network settings for exchanging ideas and best practices toward harmonization (e.g., reporting units, reference intervals, result display hierarchy).
Laboratories note that training is key to the success of implementation and change management1–5. In many cases, a customized curriculum is required to incorporate local workflows into “out-of-the-box” training materials, especially in specialized services. At-the-elbow support at go-live may help address standard functionality. Still, local experts are best positioned to discuss context-specific considerations, such as the interoperability of the LIS with instrument vendor-specific solutions. Besides training, another area that impacts staff satisfaction and go-live success is deviations from desired workflows in clinical areas upstream of the laboratory1–3. Close collaboration with non-laboratory teams on tip sheets (e.g., for ordering and specimen collection) and testing/troubleshooting can help address these considerations swiftly.
LIS implementation in non-core laboratory areas presents unique challenges, such as molecular4, flow cytometry5, cytogenetics, and HLA. In these areas, testing spanning anatomic and clinical pathology specialty laboratories and reference laboratories may be performed on split specimens (e.g., lymphoma workups) and requires extensive manual processing steps, technical and/or trainee review, pathologist sign-out, and/or result interfacing or uploads. Interfaces with vendor systems may involve significant input from institutional IT, network, and cybersecurity teams to meet a tight project timeline. Successful implementation, therefore, calls for careful orchestration of the design of ordering (especially testing for hematologic malignancies), specimen handling, and resulting/reporting workflows, as well as engagement with cross-functional groups, including clinicians, laboratorians, and IT experts.
LIS implementation is part of an exciting journey to improve the quality of care. A multi-year process culminates in the foundation for further streamlining workflows and integrating advanced data analytics tools to drive operational and quality improvements. Ongoing review and optimizations will be key to ensuring the LIS delivers its full promises.
