Pre-analytical products, automated systems, and Lean Six Sigma combined to improve outcomes

In today’s era of automation and Lean Six Sigma processes in laboratory medicine, the manual urinalysis test may be ready for a major makeover. Such a development would be welcome because, in the typical American hospital, the clinical laboratory performs an average of 120 urinalyses per day.

Some clinical laboratory managers consider it counterintuitive that—during a period of automation and implementation of Lean Six Sigma processes—a diagnostic tool as important and ubiquitous as urinalysis would not be perfectly methodized. But that is frequently the case. In many clinical laboratories, the processes utilized for this line of lab tests are often outmoded, inefficient, and can even lead to erroneous results.

For these reasons, the experience at Conemaugh Memorial Medical Center in Jonestown, Pennsylvania, is instructive. Conemaugh’s laboratory recently did a top-to-bottom makeover on the pre-analytical, analytical, and post-analytical processes it used for urinalysis testing. This comprehensive effort incorporated automated urinalysis analyzers, new specimen collection products, and Lean Six Sigma methods.

After adopting a closed urine collection system, introducing automated urinalysis, and using Lean Six Sigma methods to streamline workflow and eliminate sources of waste or errors, Conemaugh’s clinical laboratory produced some impressive results. The changes to its urinalysis testing program generated cost savings of $24,000 per year. There was also a 26% overall reduction in urinalysis turnaround time, more accurate results, and an enhanced ability in the lab to meet demand.

Clinical laboratory managers are aware that many aspects of urinalysis testing are sub-optimal. The manual test is time-consuming to perform. Too often, problems in specimen collection, transport to the lab, and specimen processing mean that the results produced by that specimen are flawed. Not only is this a waste of valuable laboratory resources, but erroneous results are detrimental to patient care.

What changed at Conemaugh’s laboratory is that, after implementing its solutions, urinalysis testing is now performed as part of a single, integrated system. In the pre-analytical stage, a closed collection system solved deficiencies in specimen collection, transport, and specimen processing. Use of an automated urinalysis system further reduced variability in manual analysis and contributed to improved accuracy in urinalysis results.

“By using a closed collection system [for urinalysis specimens], we’re improving the quality of specimens submitted to the laboratory, and this will reduce the number of phone calls back to the floors and the outpatient collection centers saying the urine is unacceptable,” stated Larry Koval, Director of Laboratory and Courier Services for Conemaugh Health Systems in a published report.

According to the published study, a closed urine collection system, such as the Vacutainer Urine Collection System (closed system) manufactured by Becton, Dickinson and Company (BDX), decreases specimen leakage and contamination to almost zero. Typically urine is collected in cups with an affixed lid. The specimen cups are then bagged and sent to the lab.

At Conemaugh Memorial Medical Center, urine is now collected in a container with an integrated transfer device. The specimen is transferred to leak-proof evacuated tubes which are compatible with the hospital’s pneumatic systems. As the pneumatic system delivers these specimen tubes to the lab, they are put directly on the automated urinalysis systems. This closed sampling system eliminates the necessity of transferring specimens from the collection cup.

In conjunction with the use of embedded customized software, the automated urinalysis analyzer supports faster turnaround time. Conemaugh’s laboratory is using the iQ200 urinalysis system manufactured by Iris Diagnostics, Inc. This is a load-and-walk-away system with throughput that supports workflow in the laboratory. The vendor says that its automated instrument will save a minimum of 10 to 15 minutes of labor time for every sample requiring microscopic analysis.

Along with better specimen integrity, improved analytical accuracy, faster average turnaround times, and reduced cost, the urinalysis improvement project at Conemaugh Memorial Medical Center offers another notable insight. To achieve these results, the clinical laboratory team did not just install, say, an automated urinalysis instruments to eliminate a manual step.

Rather, the lab team did a “top to bottom” assessment of urinalysis testing, thus, pre-analytical, analytical, and post-analytical work processes and outcomes were evaluated and addressed, using Lean Six Sigma methods. When this effort was combined with the introduction of products for specimen collection and automated analysis, this improvement project delivered impressive gains, not the least was more accurate urinalysis results that improved patient safety and patient outcomes.

This clinical laboratory management success story demonstrates how today’s most innovative laboratories no longer “patch individual problems.” Instead, they view their laboratory work flow in a comprehensive manner, with the goal of implementing a systemic improvement that fixes many problems at once, while simultaneously establishing a basis for continuous improvement.

Related Information:

BD’s summary of Conemaugh Memorial Medical Center’s study on urinalysis automation

Fairview Ridges Hospital in Burnsville, MN exemplifies success in urinalysis

Automation nudges urinalysis into spotlight