In the realm of diagnostics, clinical chemistry has been at the forefront of the technological revolution to create automated environments that enable fast, cost‐efficient, high‐quality testing. In 1978, the industry was changed with the introduction of an automated system that allowed a number of critical routine chemistry tests to be performed using one consolidated unit.1 This initial system made it possible to complete these tests, commonly ordered as a STAT, in less than one minute using a single small sample. This technology became a foundation for the future of automated chemistry testing.
While great strides have been made in chemistry testing technology, today’s clinical laboratories continue to face emerging complexities, owing largely to industry growth, an ever‐changing healthcare landscape, and network consolidations. Effective and advancing rapidly, innovation has succeeded in bringing significant relief to over‐burdened laboratories carrying the weight of increasing test volumes, stricter cost controls, labor shortages, and multifaceted network operations. In the fast‐paced laboratory environment, however, the benefits of technology are not always fully realized. For this reason, many laboratory professionals are looking beyond technology for solutions that will help them achieve their efficiency, cost, and care goals.
Industry advancements have enabled most manufacturers to produce high‐quality products with Six‐Sigma assay performance. But the availability of these products may be only part of the equation. For laboratories seeking to improve turnaround times (TATs), lower cost of ownership, and address the need for standardization throughout the organization, the other part of the equation may be to optimize available technology by building robust business systems.
Performance partnerships as a total solution
Since the 1980s, industrial companies, faced with the competitive pressures of globalization, have embraced Lean principles, Six Sigma techniques, and continuous process improvement practices to create business systems that offer a sustained competitive advantage.2 Many laboratories have sought similar solutions that would help them achieve performance goals unattainable via technology alone. This has led corporations with successful business systems to partner with their lab customers to help them apply proven continuous improvement methodologies to healthcare. These partnerships are strategic alliances formed for the purpose of elevating a laboratory’s ability to meet increasing industry demands and achieve care and efficiency goals. An established performance partner addresses laboratory operations beyond chemistry instrumentation, considering the strategic use of those instruments, workflow, resource management, and the day‐to‐day execution of tasks by personnel.
One of the roles of a strategic partner is to help laboratories optimize operations to improve TATs. This involves designing a laboratory with Lean concepts, measuring performance, and using problem‐solving techniques that drive continuous improvement. Many times, lab leaders discover that the lab was not designed in a truly strategic manner. Instead, instrumentation has been acquired somewhat haphazardly, in response to specific needs at specific times. This as‐needed approach to purchasing instruments can create redundancies in equipment and wasteful workflow. It also puts a strain on already‐stretched resources, as each system has its own training protocol, reagent requirements, maintenance schedule, troubleshooting steps, and service contract.
An instrument vendor that understands Lean processes can help identify waste in a laboratory process and can recommend changes that will provide both quality testing and operational efficiency. Process mapping is one tool that enables a laboratory to analyze its entire testing process—from sample collection to results interpretation. This exercise often enlightens laboratory personnel about areas where their current workflow is fragmented and inefficient, and enables them to implement process improvements.
Once equipment and workflow are optimized, vendors may help laboratories build a culture that supports regular measurement of key performance indicators (KPIs) and the use of tools that guide laboratory team members to action. Problem‐solving processes are an important part of continuous process improvement. They help teams identify the root causes of problems and then implement meaningful and actionable countermeasures. This step involves full‐team engagement, cross‐functionality, action‐driven response, and the input of a knowledgeable partner who can help to problem‐solve areas that need attention.
Lowering cost of ownership
Cost containment is presently a major concern in all areas of healthcare, including clinical chemistry. Lowering testing‐related costs involves a clear understanding of a laboratory’s current operational practices around expenditures and revenue. Looking merely at costs per test gives only a portion of the profitability picture. Finding and reducing hidden costs is important to maintaining a laboratory’s economic health.
One area in which hidden costs often lurk is the execution of routine tasks. These include system calibration and quality control functions, both of which are vital for ensuring that equipment performs as intended. Simplifying these activities through automation can promote testing accuracy, reduce workload, and decrease those hidden costs.
Reagent management is also time‐consuming. Storing, replacing, and thawing reagents slows down the workflow by requiring staff time and attention. Selecting concentrated reagents allows for fewer replacements, saving on both costs and time. Their smaller packages are also more easily stored. Refrigerated storage space is surprisingly expensive, and it is often not considered when evaluating new instrumentation. Thus improving reagent management can contribute greatly to a laboratory’s overall savings.
To lessen system maintenance burden, requiring precious staff-hours, many laboratories choose instruments with simpler designs that require less cleaning and troubleshooting. Reducing consumables is another way to save on overall costs. This includes using permanent glass cuvettes to minimize resources allocated for their replacements, biohazardous waste disposal, and maintenance of plastic cuvettes.
System uptime is vitally important to laboratory performance. While costs are surely impacted by a lag in uptime, there also are far‐reaching consequences. Emergency rooms and operating rooms may become impacted with patients waiting for test results. Physicians may be unable to provide patients with information in a timely manner, which could affect patient care and compromise the doctor-patient relationship. Finding systems and services designed to maximize uptime is crucial when considering costs and performance.
As it is in many industries, consolidation is a prominent theme in healthcare. Network consolidations often introduce new challenges, however, including duplication of efforts, multiplication of systems, and non‐standardization of processes. Standardizing laboratory operations across a network can improve quality, reduce costs, and maximize labor resources. Standardizing consumables simplifies inventory management tasks and allows kits to be shared across the network, saving costs, creating process efficiencies, and reducing needed storage space. Standardizing workflow means that in all areas of the network, there is consistency in systems and processes. Because of this, laboratory personnel can be cross‐trained to work in multiple areas. That is a factor that may be increasingly important as laboratories are faced with continuing labor shortages.
Beyond laboratory optimization, standardization plays an important role in patient care. With standardized processes, tests are processed the same way across a network. Result ranges are the same, so interpretation of results is consistent, not only for the laboratorians but also for the physicians. This can greatly improve laboratory performance and reduce variables that can cause error.
Despite technological advancements, today’s laboratories continue to feel the pressure to deliver accurate and timely results, manage costs, and address the challenges of network consolidations. While high‐quality products can greatly improve the efficiency and effectiveness of laboratory operations, these systems can be further optimized through superior business systems. The value of a knowledgeable partner with the ability to implement efficiencies through laboratory design, process mapping, KPI measurement, and problem‐solving processes will enable laboratories to enhance the quality of patient care through improved TATs, reduced cost of ownership, and standardization of systems and processes.
- Kricka LJ, Savory J. A guide to the history of clinical chemistry. Clin Chem. 2011;57 (8):1118‐1126. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.851.7382&rep=rep1&type=pdf.
- iSix Sigma. The history of Six Sigma. https://www.isixsigma.com/new-to-six-sigma/history/history-six-sigma/.
Jeffrey Hill, MLS(ASCP), MS, LSSBB(ASQ), PPM, has more than 20 years’ experience in laboratory science within the clinical, research, and academic spheres. He has served as a Lean consultant in a variety of fields including clinical/research laboratory, allied health services, manufacturing, customer service, and logistics. He has earned the level of Master Black Belt within the Danaher Business System and master facilitator in Lean, Leadership and Growth.