Middleware in the healthcare industry is simply defined as software that sits the bridge between laboratory instruments and the LIS and is integrated to both. The software helps automate the laboratory by providing benefits from speed and accuracy to efficiency. Clinical labs rely on the middleware to provide automatic validation and reporting of normal results and to track and manage the tests and online activity of all instruments simultaneously in the lab. Middleware functionality can be built directly into the LIS or integrated with it through best-of-breed third party applications.
Depending upon who you are speaking with in the laboratory or the facility, automation can have a very different definition or meaning; it can mean automation with laboratory instruments, automation to significantly reduce human or manual interaction with hardware and software, automatic notification, test or order entry from remote locations, report delivery, etc. The definition is more defined by the individual or lab’s perception than by an industry standard definition.
Finding the Fit
Regardless of the size or type of the lab, middleware can be a valuable asset if it is integrated with the LIS properly. Many labs make the mistake of thinking that middleware can replace the capabilities of an LIS altogether. A properly utilized middleware solution should be almost invisible to the end user. Middleware can streamline the complex processing of autoverification, integrate top-end quality control processing, and cost-effective “off-the-shelf” instrument interfaces.
Some middleware companies are trying to expand the scope of their focus to include integration with EMRs and practice management systems. While on the surface, this seems like a natural evolution of integration, in reality, EMR systems are grossly more complex and different from clinical instrumentation. This fact should be carefully considered before relying on a middleware solution to help you achieve your current and, more importantly, your future integration requirements.
In addition to the middleware providing automatic validation and notification for testing in process on instrumentation discussed above, many LIS’s are evolving to be highly automated. Barcoding enables automatic accessioning of cases. Blocks, specimens and inventory are able to be automatically tracked not only for location and count throughout the laboratory, but also for where they are in the test phase process. Cases are able to be automatically moved to next stages within the software by simply tracking where in the lab the specimen is as well as being able to electronically notify the pathologist when a case is waiting for a diagnosis, sign-out etc.
Flagging, or marking, within the LIS will also enable reports to be automatically generated based on any set of criteria (e.g., if a physician is presenting a paper or poster for reporting to the cancer registry, sending out for consult, etc.). A truly automated LIS will enable a case to be marked for consult, indicate which pathologists are affiliated with the facility and track which specimens were sent, and if and when they were returned.
Rules are able to be defined within LISs to define if new tests need to be ordered based upon certain criteria without manual intervention. With reflex testing for HPV, for example, they can be set based upon test results, age, history of patient, etc. and done by physician record.
Another example of automation is the ability of laboratory information systems to automatically notify a physician when their test results are completed. Through a robust outreach program not only can physicians order their tests anytime and anywhere-to include fully automated, electronic requisitions-they also can be notified via email, text, etc. that their test results are ready for them to securely login and receive-all via their mobile or handheld device.
In general, labs are looking for their LISs to become more robust, while at the same time increase its “lean-ness.” Many LIS vendors are faced with scrapping their entire platform to compete with the changing needs of the lab, particularly when you consider the importance of diagnostics in the field of pathology. Labs need their LIS to handle everything from increased testing menus, to outreach, to client service. Middleware is only one part of this equation. Laboratories should be looking for vendors that are able to provide a complete LIS for both anatomic and clinical pathology, including a suite of modules for microbiology, outreach, EMR integration, all fully integratible with each other, instrumentation, or any other vendor’s application. This will provide a lab with the most options for their best solution in flexibility and efficiency.
Lisa-Jean Clifford is CEO, Psyche Systems.