Enabling Flexible Laboratory Processes – Designing the Laboratory Information System of the Future Christoph Duelli Robert Keller Jonas Manderscheid Andreas Manntz Maximilian Röglinger Marco Schmidt
INTRODUCTION
Digitalization requires Laboratory Information Systems to Adapt Recent developments in the medical and industrial laboratory market boost the need for highly flexible laboratory processes. This pressure results from new requirements that go along with the internationalization of laboratories and the digitalization of formerly paper- based and bureaucratic work practices. The execution of laboratory processes is supported by laboratory information systems (LIS), which handle the control and information flow of incoming orders end-to-end. State-of-the-art LIS do not feature sufficient flexibility-to-use and flexibility-to-change capabilities. To prepare medical and industrial laboratories for the challenges ahead, LIS require more advanced flexibility capabilities that enable meeting the need for flexibility in complex laboratory processes.
SITUATION FACED
Most Processes in Laboratories Follow a Standard Process The standard laboratory process ranges from the order entry to the accounting of the laboratory service. An order could e.g. request a hemogram involving a blood sample, or an investigation for cancer in a tissue sample. Based on this order, which is enriched with customer-specific master data, the sample is analyzed and tested. After that, all test results are summarized in a single report per order. A laboratory physician then validates the results, checks the report for plausibility, and adds further diagnostic information if needed. Afterwards, the laboratory transfers the validated results back to the customer. Finally, the laboratory charges the provided services in line with current price lists and regulations.
Regulation Makes the Process Complex Example: special regulations A Spanish tourist in France gets infected with Salmonella. She appears in person at the medical laboratory for blood sampling as usual in Southern Europe. Based on a cooperation with other laboratories, the French laboratory transfers the sample to a German laboratory close to the border for analytical and diagnostic purposes. However, since the sample was taken in France and involves a Spanish tourist, both French and Spanish regulations and legal requirements apply. As a consequence, this special case requires the German laboratory to store detailed information on the blood sample (e.g., the place of blood sampling and the distance to the laboratory), which is demanded by French regulations, as well as the Spanish patient’s health insurance data in order to meet Spanish regulations. Further, the invoice is split between the patient, her employer, and her health insurances in Spain and France.
ACTION TAKEN
Publicly Funded Project Adresses The Challenge of Processual Complexity To tackle the challenges of medical and industrial laboratories, MELOS, a leading German LIS provider, and the Project Group BISE of the Fraunhofer FIT jointly conducted the LIS4FUTURE project. The project team compiled requirements on the flexibility of laboratory processes and derived corresponding requirements on the flexibility-to-use and the flexibility-to-change of LIS. Missing configuration capabilities and lacking modularity across all software architecture layers were identified as major inhibitors of flexible laboratory processes. Following an agile development process and grounded on extant knowledge, the project team developed the LIS4FUTURE demonstrator, a process-aware LIS with a modular architecture and a rule-based configuration mechanism.
Four Phases Towards the LIS4FUTURE Demonstrator The LIS4FUTURE demonstrator was used to validate the developed concepts’ applicability in real-world scenarios. The actions taken in the LIS4FUTURE project comprise four major phases, namely requirements engineering, design of the process-aware LIS with a modular architecture and a rule-based configuration mechanism, implementation and validation of these concepts by evaluating the LIS4FUTURE demonstrator. Following the agile software development principles, theses phases were conducted iteratively and in an interleaving manner.
Architecture of the LIS4FUTURE Demonstrator’s Accounting Module
RESULTS ACHIEVED
Two Major Results in the Project Based on the identified requirements, the project team iteratively developed and evaluated both the modular architecture and the rule-based configuration mechanism within the LIS4FUTURE demonstrator. A modular architecture allows for the replacement of process steps at build time. The rule-based configuration mechanism implements the possibility to tackle the ever-increasing flexibility demands at runtime. The LIS4FUTURE demonstrator shows the applicability of the developed concepts in real-world scenarios and helps MELOS develop an innovative release of their LIS in the future. Modularity Configuration
A Modular Architecture Enables Flexibility-to-Change Flexibility-to-change refers to the ability to easily further develop IS to stay aligned with changing process requirements. To incorporate flexibility-to-change in future LIS, we designed a modular software architecture that facilitates the LIS provider to easily add new functionality via modules. On the architectural level, modules can be added or replaced with significantly reduced effort. Although new modules still require a partial recompilation of the LIS, existing modules can be activated or deactivated during build time.
A Configuration Mechanism Implements Flexibility-to-Use Flexibility-to-use refers to those process requirements that can be supported without requiring major changes in the underpinning IS. To support ongoing process and LIS adaptation by flexibility-to-use capabilities, we designed a rule-based configuration mechanism. The configuration mechanism covers most of the laboratory process’ flexibility requirements in terms of routing and calculation decisions, based inter alia on examination results and price lists. Consisting of rules and plugins, the configuration mechanism provides software developers and LIS users alike with a high level of customizability.
LESSONS LEARNED
Five Lessons in Three Domains Were Learned During the Project The process perspective: The architecture perspective: The organizational perspective: Lesson 1: Rely on both flexibility-to-use and flexibility-to-change IS capabilities to prepare for future flexibility requirements on the process level. Lesson 2: Incremental improvement is not always sufficient to achieve a target. Lesson 3: The software architecture must be aligned with process thinking. Lesson 4: Discussions among academics and practitioners are more effective if they build on running prototypes instead of theoretical concepts Lesson 5: If you want your team members to communicate, collocate them.