Harmonization in laboratory medicine: more than clinical chemistry?

Abstract

Abstract:The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. "omics") rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only "good biological samples" can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the "pre-preanalytical" phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the "post-post-analytical" steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks

“…Therefore, establishment of an efficient network of regional clinical laboratories, involving those which are not directly challenged by the outbreak and where samples can be conveyed, is a feasible solution, provided that a straightforward regulation for specimen transportation and biosafety is set and monitored ( Figure 2). This, in turn, highlights an unavoidable need to place major efforts for allowing better and wider harmonization of laboratory results and information, encompassing both analytical and extra-analytical issues [26][27][28].…”

Reflex and reflective testing practice in Clinical Biochemistry in the United Kingdom – a national survey

“…In the recent publications about harmonization in laboratory medicine, it has been emphasized that despite years of advances in laboratory quality, which has been primarily focused on the analytical phase, we are still struggling to harmonize significant areas of the total testing process, which includes areas such as reference ranges, report formats, decision limits and criteria for interpretation. 10 , 11 The practice of adding on tests is widespread in the UK; however, this survey has shown that significant variation exists in how this is performed and whether additional testing falls under reflex or reflective testing. Here, we aim to provide some discussion and proposals based on the various scenarios surveyed and the current evidence base around these topics.…”

Integrated diagnostics

“…An essential issue in this efforts to provide integrated and high quality information is represented by harmonization of clinical data. In particular, further efforts should be promoted to provide harmonization and standardization in laboratory medicine, not only in the analytical phase but also in all steps of the total testing process (76)(77)(78).…”