On the Hunt for Laboratory Errors

A hugely important goal in modern medicine is the improvement of patient safety. Although the maxim “primum non nocere” – a central element in any medical practice – dates back many centuries, the publication of the US Institute of Medicine (IOM) report on diagnostic error has shone a spotlight on the need to reduce risk in clinical practice by minimizing medical error (1). The data collected on medical errors – and especially on their prevention – has not only led to an ever-growing awareness, but has also kicked off initiatives aimed at reducing the error rate, with a particular focus on those correlated with adverse events for patients.

We have definitely seen improvements in patient outcomes from initiatives aimed at reducing procedural errors, or those in drug administration and dose. But what of diagnostic errors? In recent years, evidence has been collected on these types of medical mistakes, their severity, and the need to improve the diagnostic process as an essential prerequisite for ensuring better health and economic outcomes. Over the past few weeks, WHO has intensified its focus on this topic, launching a global initiative to slash medical error by 50 percent over the next five years. The project, along with the IoM report, is the result of many recent studies aimed at documenting the severity of the diagnostic error problem. It highlights the need for programs to understand the nature of the errors and develop effective interventions, thus increasing the safety of the diagnostic path.

Many medical professionals may be surprised to learn that diagnostic error is now the most common type of medical mistake in clinical practice, at least in the United States and other developed countries. It is also the type of error most closely associated with mortality and morbidity; according to a recent estimation, diagnostic error mortality in American hospitals ranges from 40,000 to 80,000 cases per year (2). And to add insult to (literal) injury, it is additionally the most significant cause of unnecessary expenditure and liability reimbursement for those hospitals.

Notably, most laboratory errors are not the result of analytical test inaccuracy; rather, they are a reflection of problems with test selection, sample collection and manual handling, and appropriate interpretation and use of results. The latter issue in particular is responsible for the 5 to 8 percent of laboratory errors associated with the greatest risk of harm to the patient (3).

The vulnerability of the pre- and post-analytical phases is now universally acknowledged. The analytical phase, in contrast, has improved significantly in recent decades – primarily because of better training and increased use of quality indicators, but the introduction of automation and information technology has also helped. For example, my laboratory – the Clinical Laboratory of the University of Padua – has adopted a solution (Inpeco SA's ProTube) to ensure that patient data, samples and test results are all correctly matched. And it has contributed to a significant decrease in error in this phase of testing. The development of a harmonized model of quality indicators – in this case, for misidentification errors – creates opportunities to identify and correct the processes most exposed to the risk of error at each stage of the testing pathway (4).

The challenge? To move from analytical data management to “total sample management,” and to achieve a total laboratory information management solution that ensures traceability, security, and the appropriate interpretation and use of laboratory data.