The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe

Abstract

Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe.

The preanalytical phase – Past, present and future

“…11 There have been a series of European biannual conferences organized by the EFLM WG PRE discussing the preanalytical phase, and from these, eight preanalytical aspects were identified, prioritized for standardization and the progress made was summarized in 2016. 12 The successfully addressed issues covering some of these areas include:…”

“…This may be via direct education sessions, eLearning or via direct feedback through sample reports or verbally. 12,21 Some tests require specific patient preparation, e.g. fasting or other lifestyle or medication adjustment for a period prior to testing.…”

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

“…The assurance of quality throughout the total testing process has always represented a crucial issue in laboratory medicine. Despite the advances that have unquestionably allowed to achieve a much greater degree of quality and safety in diagnostic testing, many hurdles still remain to be overcome, especially in all those activities ranging from test ordering to obtaining and managing the biological specimens [3][4][5]. In keeping with these issues, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has established a specific Working Group for the Preanalytical Phase (WG-PRE), the aims of which are mainly aimed at mitigating the vulnerability of many preanalytical activities, releasing official documents, guidelines and recommendations, as well as providing continuous education for laboratory professionals and other healthcare operators.…”

The EFLM strategy for harmonization of the preanalytical phase

“…The terms of reference of this WG are many and ambitious, encompassing (i) the promotion of importance of quality in the preanalytical phase; (ii) definition of the best practices and release of guidelines or recommendations pertaining the most vulnerable steps of the preanalytical phase; (iii) design, validation and dissemination of surveys and questionnaires intended to assess the current preanalytical practices; (iv) organization of meetings, symposia, workshops, webinars or other forms of educational courses on preanalytical phase issues [12]. These objectives were originally established for improving quality in clinical and laboratory practice, but were then broadened to other domains of science and medicine such as clinical research trials, in which the quality of the preanalytical phase is at least as important as in routine diagnostics [13].…”