The emerging importance of the pre-pre-analytical phase in reducing testing errors and improving patient safety

Errors in diagnostic testing can impact patient safety and represent an increased cost burden for busy laboratories.¹ As a result, over the last two decades laboratory teams have shown an increasing interest in identifying and resolving analytical errors. 

Pre-analytical errors have been observed to account for the lion’s share of errors observed across the analytical workflow.² However, a particular sub-set of pre-analytical errors, in the so-called “pre-pre-analytical” phase are now coming under increased scrutiny. These errors occur before samples reach the lab and can include mistakes in sample labeling, incorrect patient identification, or non-refrigerated samples. These errors affect the downstream analytical phase of the diagnostic process.  

Prof. Dr. Plebani, Honorary Professor of Clinical Biochemistry and Clinical Molecular Biology-University of Padova and Adjunct Professor University of Texas is a strong advocate of the importance of addressing pre-pre-analytic errors to protect patients and to improve diagnostic testing and downstream care. His recent presentation at the 25th EuroMedLab Congress was a timely reminder that we must act now.

In August 1997, Prof. Dr. Plebani and his colleague Paolo Carraro published a ground-breaking study in the Journal of Clinical Chemistry.¹ The publication in question documented types and frequencies of errors in the laboratory testing process and in doing so, reshaped our understanding of quality in laboratory medicine. Interestingly, the study revealed for the first time that the pre- and post-analytical phases are far more susceptible to errors than the analytical phase.

A decade later in 2006, the study was revisited by Prof. Dr. Plebani and his co-author.² Using the same study design, they demonstrated that the overall frequency of analytical errors at their center had marginally decreased (4667 parts per million [ppm] to 3092 ppm; p <0.05). However, these pre- and post-analytical phases' error rates were still judged to be unacceptably high.

Prof. Dr. Plebani explained that the results of this study were particularly important as they were the first to demonstrate the need to split the pre-analytical phase into two parts. As a result of this study the term "pre-pre-analytical was coined, to describe the initial steps that a specimen undergoes before it reaches the laboratory.” The study identified numerous opportunities for error during the pre-pre-analytical phase, which were examined in more detail by Prof. Dr. Plebani during his presentation.  

Common errors include inappropriate test requests, issues around order entry, misidentifying patients, mislabeling of specimens, or poor sample collection, Prof. Dr. Plebani said, adding that it's important to address these issues with nurses and medical doctors as they have a crucial role to play in ensuring the pre-pre-analytical phase is carried out correctly. He reflected: “If you would like to increase patient safety, you have to work in the pre-pre-analytical phase.”

Prof. Dr. Plebani then expanded on the relationship between the various analytical phases.³ He explained that the take-home message from his publications in the last few years has been that “good samples make good assays”. Prof. Dr. Plebani also described his theory of the “Five Rights” in the pre-pre- and pre-analytical phases. 

In the pre-analytical phase, the Five Rights include the right separation, pre-treatment, aliquoting, sortation, and routing of specimens. In the pre-pre-analytical phase, the Five Rights concern the right patient i.e. the use of the correct sample, the use of the right test at the right time, and the right method of sample collection and transportation. To summarize, Prof. Plebani remarked that if the sample quality is compromised, it is impossible to achieve accurate results, even with excellent analytical instrumentation.⁴

Two key approaches will allow us to improve pre-pre-analytical quality, namely professional education and technological innovation. In line with this, Prof. Dr. Plebani summarized an editorial he had written in the American Journal of Clinical Pathology.⁵ The editorial stated that to improve the pre-pre-analytical phase, we must first change our mindset and culture to be more oriented to its improvement. Pre-pre-analytics is an emerging field and the industry must work on raising awareness of its importance in impacting the quality of diagnostic testing.

Technological advancements, such as the introduction of automation and traceability solutions, have significantly reduced pre-pre-analytical error rates in laboratories and outpatient facilities. An open ecosystem of innovative companies is therefore a proposed solution for improving pre-pre analytic operations for labs.

Prof. Dr. Plebani then discussed his participation in a groundbreaking new framework that is linking together a number of stakeholders across the analytics spectrum. The goal of the framework is to facilitate collaboration between analytical stakeholders and as a result, promote innovation related to the pre-pre-analytical phase. A pilot study assessing the new framework is currently underway at Verona Hospital.

Toward the end of his talk, Prof. Dr. Plebani considered the speed at which the translation of research insights into clinical practice occurs. He discussed the results of a recent study from Korea which indicate that despite years of research into the topic, pre-analytical quality still remains inadequate in many laboratories.⁶ In order to further explore this topic, Prof. Dr. Plebani also presented a study that demonstrated that it can take 17 to 20 years for research insights to be implemented in the clinic.⁷ In his final statement, Prof Plebani reflected on this data, giving a call to action: “We have to work right now to improve pre-pre-analytical quality.”

If you want to hear more from Prof. Dr. Plebani and how to improve pre-pre-analytical errors in the lab, then click here too register too watch his full presentation.