Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Data management/LIS integration with software and instruments
3.2. LIS integration with software and instruments
Given that a clinical laboratory's workflow often includes analytical instruments and other software, it makes sense that those tools should be able to interface with a data management system like an LIS. Today's interfaces are generally built on standardized communication tools, including messaging formats like Health Level 7's (HL7's) FHIR.[1] Arguably, this interoperability may not be a requirement for POLs performing waived testing; CLIA-waived tests don't often require advanced equipment, and the POL may not even need an LIS to manage patient test data. But for those POLs that employ laboratory automation, the ability of clinical analyzers to send their data to a central laboratory information system is important to maintaining a streamlined, efficient workflow.
The HL7 messaging standards are particularly important to laboratory data management because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration of various systems and instruments.[2] Over the years, Health Level 7 has described the types of information communicated between such systems in the clinical environment as including "process control and status information for each device or analyzer, [as well as] each specimen, specimen container, and container carrier; information and detailed data related to patients, orders, and results; and information related to specimen flow algorithms and automated decision making."[3]
3.2.1 EHR-LIS integration and interfacing
Integration of clinical and physician systems usually requires an interface—often referred to as a result interface—which isn't typically turnkey, begetting the need for a comprehensive development plan and implementation process.[4] If designed well, the interface allows test orders and results to be transferred back and forth between the two systems, and it permits batch billing and admission/discharge/transfer (ADT) reporting to occur.[1]
Up until recently, the reality, however, for particularly large laboratories accepting test orders from multiple physician offices has been that tens of different interfaces may need to be developed, one for each different EHR. The end result: an unnecessarily complex process of transferring data between systems.[5] One possible approach to this problem was suggested in 2015 by Dr. Donald M. Voltz: integrate systems through middleware, software similar to a result interface that connects one or more other software applications. From his point of view, a proper middleware solution could connect dozens of EHRs, creating interoperability.[6][7] Though Voltz promoted middleware as a solution to EHR-to-EHR integration, its applicability to integrating an LIS to an EHR is still highly relevant.
In fact, the College of American Pathologists' CAP Today publication reported on the trend of middleware development for POLs in 2011, for not only software-to-software integration but also software-to-instrument integration. "For the right POL, middleware can provide a user-friendly, flexible, cost-effective method for interfacing their IVD [in vitro diagnostics] instruments directly to the EHR without the need for an LIS," said Dawning Technologies' Jay Sax.[8] Today, thanks to wider adoption of HL7, FHIR, POCT1-A, and other standards, more powerful middleware solutions capable of interfacing instruments, EHRs, and even LISs are available to the POL. See Table 1 for a representative sampling of such middleware.
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Some software developers have also attempted to simply add LIS functionality to an EHR (EHR-LIS). But this approach has its drawbacks. In 2012, the College of American Pathologists' (CAP's) Diagnostic Intelligence and Health Information Technology (DIHIT) Committee identified several issues with this approach, including[9]:
- a limited feature set, with little incentive to increase functionality;
- a failure to eliminate the need for interfaces with other systems;
- an encounter-specific approach rather than a specimen-centric one; and
- an inability to handle outreach volume and operations.
In fact, a 2022 market report by Signify Research shows that the EHR-LIS has made significant inroads at the expense of the "best of breed" LIS, primarily due to the "comparatively lower price point" and simplification of the IT supply chain. However, Signify also notes that such EHR-LIS hybrids generally come with the some downside, such as "a loss in specialization for workflows and lab types."[10]
Another longstanding complaint about EHRs and the way they interface with an LIS: many don't handle test-related activities well. "[O]nly a handful of EHR products are good at supporting optimal workflow for lab test orders and lab test reporting," according to a 2015 report from Dark Daily.[5] That same report also mentions how when test results are finally transferred back from an LIS to an EHR, the associated report will often end up "in a secondary location within the EHR, in effect separately from the patient-centric screens the physician uses to view all data needed for diagnosis and treatment of a patient," which as a result "may require the staff to print out the lab test results, which defeats the purpose of an electronic interface."[5]
As such, any POL performing sufficient volumes of testing to benefit from using an LIS may also want to consider the costs and drawbacks, if any, of interfacing to their EHR system. In a case where the POL is in a position to consider both an LIS and an EHR at the same time, examine the features and potential integration of those products, and be sure to consider any future potential of integrating your systems with other external data management systems, including another reference laboratory. If considering an EHR that includes some LIS functionality, be sure to clearly identify the functional requirements and thoroughly demo the system to ensure test and reporting workflows make sense.
Finally, in cases where POL test volumes are low—coming from only one or a few instruments—and an LIS is not required, POL operators may want to simply consider a middleware option that smoothly facilitates the flow of instrument data to the EHR.
References
- ↑ 1.0 1.1 Sinard, J.H. (2006). Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist. Springer-Verlag. doi:10.1007/0-387-28058-8. ISBN 9780387280585.
- ↑ Kim, K. (July 2005). "Creating Clinical Data Standards in Health Care: Five Case Studies" (PDF). California HealthCare Foundation. Archived from the original on 14 January 2017. https://web.archive.org/web/20170114055221/http://www.kathykim.com/sitebuildercontent/sitebuilderfiles/ClinicalDataStandardsInHealthCare.pdf. Retrieved 17 May 2022.
- ↑ Health Level Seven International (2011). "HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation". Archived from the original on 28 June 2017. https://web.archive.org/web/20170628160314/http://www.hl7.org/implement/standards/product_brief.cfm?product_id=203. Retrieved 17 May 2022.
- ↑ Kasoff, J. (February 2012). "Connecting your LIS and EHR". Medical Laboratory Observer. https://www.mlo-online.com/home/article/13004285/connecting-your-lis-and-ehr. Retrieved 17 May 2022.
- ↑ 5.0 5.1 5.2 "How Medical Laboratories Help Physicians Overcome the Failure of Many EHR Systems to Support Effective Lab Test Ordering and Lab Result Reporting". Dark Daily. Dark Intelligence Group, Inc. 30 March 2015. https://www.darkdaily.com/2015/03/30/how-medical-laboratories-help-physicians-overcome-the-failure-of-many-ehr-systems-to-support-effective-lab-test-ordering-and-lab-result-reporting-330/. Retrieved 17 May 2022.
- ↑ Voltz, Donald M. (May 2015). "Connecting the Disparate: Middleware’s Role in Solving Healthcare’s EHR Interoperability Problems". Journal of AHIMA 86 (5): 28–33. https://library.ahima.org/doc?oid=107645. Retrieved 17 May 2022.
- ↑ Voltz, Donald M.; Tran, Thanh (2 June 2015). "Can a Middleware Prescription Cure Healthcare’s EHR Interoperability Disorder?". Electronic Health Reporter. millerrupp. https://electronichealthreporter.com/can-a-middleware-prescription-cure-healthcares-ehr-interoperability-disorder/. Retrieved 17 May 2022.
- ↑ Wagner, Karen L. (March 2011). "Middleware to ‘littleware’: vendors catering to smaller labs" (PDF). CAP Today. College of American Pathologists. http://www.captodayonline.com/Archives/0311/0310_CAPTODAY_MiddlewareSystemsGuide.pdf. Retrieved 17 May 2022.
- ↑ Sinard, John H. (2012). "Pathology and the LIS in the Era of the EHR" (PDF). College of American Pathologists. Archived from the original on 29 August 2015. https://web.archive.org/web/20150829164712/http://www.pathologyinformatics.org/sites/default/files/Sinard_CAP%20DIHIT%20Committee_API_SS_2012.pdf. Retrieved 17 May 2022.
- ↑ Fitt, I. (26 May 2022). "Why BoB LIS vendors might yet survive EHR’s invasion". Signify Research. https://www.signifyresearch.net/healthcare-it/why-bob-lis-vendors-might-yet-survive-ehrs-invasion/. Retrieved 30 May 2022.
