Testing of urine samples for diagnostic purposes began more than 6,000 years ago. From ancient times, to the technique’s pinnacle of popularity in the Middle Ages, and then into the Victorian era, a patient’s urine was used to both diagnose and foretell. Fast forward to modern times, urine tests are one of the most commonly ordered tests. No longer recorded on clay tablets, laboratories are pressured to produce accurate, valid, and high-quality results that provide clinical value to the physician, all while meeting turnaround time expectations with less staff and tightened budgets. Decreasing reimbursements, increased test utilization oversight, and regulated clinical quality metrics add to the stress of reducing clinical laboratory test volumes and budgets while increasing quality assurance monitoring and documentation. Because of the challenges faced by today’s labs, solutions are required that streamline workflow and reduce the labor-intensive manual processes of traditional urinalysis methods while minimizing operating and capital expenditures.
State of urinalysis
In the mid 90’s, automated quantitative analysis of formed elements in urine combined with flow cytometry technology lead to a reduction in the fundamental need for laboratory technicians and technologists to perform manual microscopy in the urinalysis department. However, samples that were flagged as abnormal by the analyzers still needed to be confirmed visually, so laboratories centrifuged samples and performed sediment reviews. Such manual methods lacked precision, leading to potential variation in results. Just two years ago, improvements in automation brought standardization to urinalysis testing. Today, clinical laboratories are focusing on integrated systems with features such as calibration, sample transport technology, and test scheduling capabilities; however, these systems remain incomplete, missing the benefits of either flow cytometry or urine digital imaging.
While extensive advancements have been made in urinalysis, especially with automation, there is still much room for improvement. Physicians could enjoy greater confidence in diagnostic decision making if given more accurate and precise results. There is a need for better sensitivity and specificity in bacteria detection, as well as a need for more efficient differentiation of Gram-Negative and Gram-Positive bacteria to support treatment options.
Advancements in quality control and quality management practices could also benefit the urinalysis lab. Performing laborious manual reviews of quality statistics is time consuming and current systems do not enable an efficient approach to meeting regulatory compliance requirements. And while closed-tube sampling (CTS) technology or cap piercing offers many user benefits including efficiency and safety, a low-cost standard for this feature means many laboratories don’t get to experience the benefits of cap piercing. This is especially challenging for high-volume laboratories.
The dream urinalysis department
Take a few moments to imagine the perfect urinalysis department. This dream department is equipped with a “fully” automated urine particle analyzer, reducing the need for manual slide reviews and delivering first-pass accuracy and unprecedented workflow efficiency. The ideal automation consists of a modular system that offers the flexibility to meet every laboratory’s needs—in other words, this dream lab is fully customizable. Multiple instrument configuration options would offer simple upsizing and downsizing should physician order profiles change, or solution splits become necessary. Throughput could be increased by adding chemistry analyzers, flow cytometers, or digital image analysis components as needed. Decreased specimen handling would eliminate the opportunity for clerical errors. More accurate test results could be achieved with greater standardization and advanced automation. This dream analyzer would have intelligent software that allows for rules-based workflow management and result interpretation that is specific to the laboratory policies. It would be an innovative system with automated quality control monitoring and the ability to send messages to laboratory managers or service representatives when the device requires attention. It would also provide laboratory personnel with easy-to-read troubleshooting guidance and real-time reporting of analyzer status. This dream urinalysis department is supported with advanced tools, training, and quality control options, offering the best of modern technology and personal support to ensure the laboratory’s success.
Tools
Advanced tools and powerful software systems are specifically designed to drive greater insight into—and control over—both processes and information across the healthcare network. Automating instrument calibration and calibration verification programs offers a reduction of non-productive analyzer time. Business intelligence reporting allows improvement of clinical performance, productivity, and staffing decision-making. Mobile technology tools enable sharing of analyzer performance history, workflow analytics, and educational requirements throughout an organization.
Training
Training is essential to expanding the diagnostic knowledge of staff and helping laboratories deal with the growing challenges of personnel shortages. It plays a key role in ensuring that laboratories get the most out of the investments they make in both hardware and software. In-person training, regional conferences, and user groups are good options for continuing education, but access is limited, and labs may incur expenses and/or inconvenience. Conversely, web-based training programs ensure that all technologists receive standardized training from the manufacturer, assuring consistent knowledge within a lab or across a lab network. Webinars, e-learning, and self-paced training platforms also enable better efficiency and lower costs of training employees.
Quality control and management
New and inventive approaches to simplified, fully integrated, and automated analyzers lend themselves to web-based quality control and management. Such innovation will streamline the process of running controls and verifying result acceptability. This occurs by identifying issues systematically through routine and traditional quality control approaches, so problems can be resolved before the laboratory even knows one exists. Predictive monitoring will take data interpretation to the advanced level that is needed to overcome today’s challenges.
While the pressures of staffing challenges and declining reimbursement combine with growing demands for result accuracy and workflow efficiency, the need for new and innovative products becomes more apparent. Manufacturers will be expected to provide automated processes, tools, and service support that maximize instrument uptime. Current lab leadership will need to form partnerships with healthcare diagnostic companies to bring such solutions to market in the future. Laboratory purchase decisions will continue to be based on quality and reliability, as well as system flexibility and superior technology, all of which are needed to give technicians more time to apply their expertise analyzing test results.
