Today’s healthcare climate challenges the clinical laboratory to offer improved patient care while reducing costs and increasing efficiencies. There is no room for error, however small.
Seventy percent of all medical decisions are made based on high-volume laboratory testing and the corresponding results.1 Critical information in the clinical laboratory directly impacts patient care and must be delivered with excellence. Performance improvement initiatives to optimize the lab are integral to achieve key quality benchmarks. Methodologies must be put in place that safeguard against lab errors at all stages, and a culture must be developed in which staff will not hesitate to report deficiencies. Leadership also must be engaged and provide oversight at all levels within the health system to be effective. While the frequency of errors in the clinical lab is generally lower than other departments across a health system, any error that impacts quality patient care is too many.
The impact of error
Errors are a lab’s worst enemy because they increase waste—wasted time, resources, and supplies. These wastes cost the lab money, decrease its efficiency, and ultimately pose increased risks for the patient.
Clinical labs perform billions of tests each year. The results represent the bulk of a patient’s electronic medical record, and they are a key driver of medical decisions. Given the volume of tests performed, even if only a small fraction have errors, large numbers of patients can be affected. While the impact on patient care is not something we can easily apply a value or a dollar amount to, the bottom line is that every test matters, and labs need to consistently deliver the right results for the right patient at the right time.
Phase by phase
Testing presents challenges across the phases—pre-analytical, analytical, and post-analytical—so all three should be reviewed and addressed.
The majority, probably the large majority, of errors are associated with the pre-analytical phase. Mislabeled specimens are the most costly. Whether specimens are collected by phlebotomists or nurses, the laboratory has a major role in identifying, tracking, and correcting errors. Larger hospitals and health systems have accelerated their use of positive patient ID barcoding and handheld printers to print patient labels at the bedside as one method of addressing the problem. In facilities where this has been implemented, a drop to almost zero patient ID errors during patient specimen collection has been observed.
To further tighten up the patient identification process, the next step in achieving quality excellence is to track “near misses.” Under-reporting can be an issue in this context. To empower staff to report near misses, there often needs to be a culture shift in which potential errors are de-personalized and the entire organization looks at the process that resulted in the error. Health systems that have a strong Lean program or have adopted the practice of “Just Cause” typically approach errors in a manner that empowers staff to speak up about potential errors.
For the analytical phase, emergency department (ED) test turnaround time (TAT) is one of the most common metrics. Labs use this metric to evaluate how well they perform some of their most critical tests. Delays in delivering the test results can lead to delayed patient care and extend length of stay in the ED. When evaluating how a lab is performing on ED TAT, multisite hospital laboratories often have the added challenge of disparate criteria for evaluating what constitutes good performance. To address this, all stakeholders should be involved to define TAT acceptance criteria and measure their performance against internal and external benchmarks. Being able to identify where there are gaps in performance and making them visible allow the laboratory team to take steps to close those gaps.
As the quality process matures, the lab can move from measuring the outcome metrics (ED TAT) to focusing on the leading indicators that drive the TAT (for example, non-barcoded tubes, QNS samples). Implementation of quality-leading indicator metrics and a robust program to review and act quickly on the results are staples of laboratories that successfully eliminate errors at this stage.
The post-analytical process is the final step. The sample was successfully collected, and the lab has completed the ordered tests. Now all that is left is to tell the physician. Errors at this stage in the process range from sending results to the wrong physician, to having to resend the results because they didn’t arrive, to failing to call physicians with critical value results in a timely manner.
Technology can play an important role in reducing errors in this stage. In the outreach environment, non-affiliated physician groups can be connected directly to their laboratory results through a portal, so the right physician receives his or her patients’ results (usually the same day). This saves significant non-value added time for laboratory staff, who no longer need to manually mail/call results to physicians—a process that is in itself susceptible to errors. Being able to reduce the number of errors and improve the consistency of result delivery helps a lab demonstrate an improved quality maturity level. This in turn leads to increased physician satisfaction and the lab becoming the physician’s “lab of choice.”
Once a process change has been put into place, the only way to maintain that change is through ongoing, proper monitoring of the process. This requires regularly tracking and displaying the performance of the leading indicators and differentiating between normal and special cause variation in results (control charts are especially helpful with this). Successfully sustaining a positive process change also requires a culture where staff work together to identify problems. When the entire team takes ownership of its performance and is supported in its goal to achieve zero defects, the impossible goal of “perfect” quality becomes approachable.
The next 20 years will see advanced clinical labs taking on a more significant role in healthcare delivery. Using advances in technology and analytics and developing a culture of excellence will allow laboratories to improve their quality and service and mature into powerhouses for positive patient care. The success of the lab of the future depends on the work we do today to increase efficiency, utilization, and quality.
- Hallworth MJ. The ‘70% claim’: what is the evidence base? Ann Clin Biochem. 2011;48(6):487–488; doi: 10.1258/acb.2011.011177.
Jeff Osborne is the Chief Executive Officer and President of Accumen, Inc. (and its subsidiary, Chi Solutions, Inc.), which provides clinical laboratory consulting, outreach, comprehensive patient blood management (cPBM), and laboratory excellence solutions for hospitals and health systems.