LIS development has historically been influenced by the need for laboratories to comply with a plethora of regulatory requirements. Laboratories have always faced changing regulatory requirements, but never more so than now – as our overall healthcare system struggles to reinvent itself into a system where patient outcomes and value drive reimbursement rather than the volume of procedures performed. The Patient Protection and Affordable Care Act (PPACA) is the largest change to our healthcare system since the introduction of Medicare in 1965. It is the beginning of a complete restructuring of how healthcare in the United States is delivered, and one of the reasons these improvements in healthcare are possible is because of advances being made in information technology.
In addition to the PPACA, the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program is driving the use of EHR technology, and consequentially having a profound impact on the functional needs of the LIS. Prior to the EHR, orders were placed in the LIS, making medical necessity flagging and Advance Beneficiary Notice (ABN) printing important functions for the LIS. With Meaningful Use (MU) now in full swing, the majority of lab orders are placed directly in the EHR using Computerized Physician Order Entry (CPOE), making this pre-analytical functionality less important in the LIS.
As change continues, the future of healthcare will require a shift in focus and will bring new responsibilities to the laboratory that include a broadening of the laboratory’s focus beyond workflow efficiency to include positive measurable impact on patient outcomes. This initiative will make new demands on the LIS. Not only are test menus changing and expanding, but test methodologies and workflow processes are advancing. Laboratories are under pressure to reduce cost, maintain efficiency and quality testing, and demonstrate value that reaches beyond the walls of the lab. Being one of the most vital tools a lab uses, the LIS must evolve alongside the laboratory to aid in this progression.
Provide analytics to support best test utilization
One of the areas in which laboratories can be of crucial benefit is in driving proper and best test utilization, and the LIS can be a valuable tool to collect and sort this data. Crystal Run Healthcare, a multi-specialty group practice in Middletown, NY, part of a Medicare Shared Savings Program ACO, closely examined its provider ordering patterns to achieve the cost savings and efficiency needed to thrive in an accountable care environment. In collaboration with ordering providers, their laboratory analyzed provider ordering patterns for specific diagnoses. Using LIS data generated by the lab order variation analysis, combined with associated costs and actual patient outcomes, they were able to standardize care and reduce costs while still maintaining high levels of quality. After six months of following the best-practice guidelines that they developed for ordering lab tests on diabetic patients, Crystal Run saw a 9 percent reduction in the overall cost of care and a 15 percent reduction in lab costs.
Support automated testing algorithms
Another area directly related to best test utilization that your LIS should be capable of supporting is the implementation of automated testing algorithms or cascades. At East Tennessee State University Clinical Laboratory, to promote appropriate testing and reduce waste, they are using their LIS to automate reflex testing and to develop and automate more complex testing cascades. Proper implementation of testing algorithms that cascade through a logical testing sequence based on initial results, developed in tandem with ordering physicians, can eliminate providers having to choose from an overwhelming menu of hundreds of available tests. These algorithms can be instrumental in making sure that only the appropriate tests are ordered. Laboratory-driven algorithms, i.e., where clinicians order a testing cascade and initial laboratory results drive subsequent test selection, allow the laboratory to handle the entire cascade process with no further input from the provider (see example Algorithm for Thyroid Testing in Figure 1).
In order to efficiently track test utilization by provider or by diagnosis, and to configure automatic reflex testing and algorithms, a robust LIS is a crucial tool that laboratorians need to support their test utilization program. Essential provider utilization data can be presented in an easy-to-interpret format. Although some data can and will be generated from the EHR, the rules-based decision-support technology that enables reflex cascades has to take place at the laboratory workflow level within the LIS. By combining the rules technology and data analytic capabilities of a strong LIS, laboratories have a tremendous support tool and can develop a dynamic, ongoing test utilization program.
Deliver valuable laboratory analytics
Changes to our healthcare system demand that we find a way to provide better patient care and simultaneously spend less money. This challenge shines a light on the need for laboratories to focus on greater productivity, maximum efficiency and useful data analytics that can guide future business decisions. The shift to a value-based system brings to light the need for integration and business analytics. Analytics will be the key to survival in the new payment models. Laboratory analytics can provide management data that can boost lab productivity, and the LIS of 2015 going forward must be able to provide detailed laboratory analytics to assess and improve laboratory efficiency. This includes analytics for turnaround time, physician utilization, staffing workload, auto-validation percentages and quality measures, such as tracking rates of blood culture contamination, hemolysis, QNS and cancellations. These solutions must be rapid in order to proactively address problems head on and develop time-efficient solutions.
ROI that reaches beyond the lab
At the University of Mississippi Medical Center, in order to reduce unnecessary testing and provide greater diagnostic value, Brad Brimhall, M.D., Ph.D., and team introduced MALDI TOF testing for blood cultures. In a traditional financing scenario, it would have taken 20 years to pay for their MALDI TOF analyzer. However, by looking at the value of implementing a test methodology with much greater diagnostic efficiency, and thereby significantly reducing hospital length of stay, Dr. Brimhall was able to demonstrate the ability to pay for the analyzer in only 12.6 weeks. This example clearly points out that lab analytic data is essential for labs to determine if they are running in a cost-effective, optimized way and to demonstrate value and ROI beyond the lab.
Advances in technology – preparing for the future
Another LIS trend to look for, probably not in 2015 but not too far in the future, is the ability to handle the advances being made in testing methodologies in the molecular and genetic testing arena. These changes, encouraged by legislation, are occurring quickly. As new, more complex testing becomes available and the need to make results available to clinicians faster continues to ramp up, this trend is heavily shaping laboratory dynamics and future LIS development.
Laboratory professionals are finding new opportunities to update testing menus to reflect organization-wide savings and improved patient care, to be involved in best test selection and to include value-added test interpretations on reports. In order to continue to be a vital tool, the LIS must evolve to support initiatives that allow laboratorians to expand their role and increase their lab’s efficiency.
Powerful and flexible LIS imperative
Our healthcare system is revamping to become more patient-centric and more efficient, using IT tools to help achieve this. Going forward, laboratory professionals must find ways to use diagnostic testing to impact the total patient episode of care. Focus will not only be on performing accurate tests, but on finding better test methodologies and opportunities to improve the overall health of patients and the population in general. The lab will be required to expand its reach beyond the lab and will need the necessary IT tools to support this shift in culture.
As diagnostics moves toward the use of genomics and personalized medicine, laboratories will need a strong informatics partner who is extremely agile and able to adapt as testing patterns shift and workflow enhancements take place. Software tools must be able to continually advance and become more sophisticated to support more standardized, data-driven, best-practice models. In order to face healthcare’s future, laboratory software must have the functionality to allow the laboratory to be a part of the clinical decision support system for providers – enabling laboratorians to meet their full potential.
