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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 56, Issue 10

Issues

Harmonization in laboratory medicine: Blowin’ in the wind

Mario PlebaniORCID iD: https://orcid.org/0000-0002-0270-1711 / Maria Stella Graziani / Jillian R. Tate
  • Pathology Queensland, Chemical Pathology Department, Royal Brisbane and Woman’s Hospital, Herston, Queensland, Australia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2018-07-09 | DOI: https://doi.org/10.1515/cclm-2018-0594

Despite monumental advances in quality improvement over the past few decades, clinical laboratories are still under increasing pressure to achieve efficiency, timeliness, safety, effectiveness and patient-centered services [1]. Laboratory tests are required for fulfilling the healthcare needs of individual patients and populations; they are critical to predict susceptibility to and prevent disease, to achieve early diagnosis and effective monitoring, and to determine prognosis and personalize treatment to get the best outcomes. They are critical to the management of communicable and noncommunicable diseases, surveillance of emerging infectious threats such as Ebola and Zika viruses, the safe and rational use of essential medicines, including stewardship of anti-infective agents to reduce the likelihood of the development of microbial resistance. Improved access to diagnostics has been shown to double the rate of adequate glycemic control, and to quadruple the number of cases of human deficiency virus infections detected [2]. However, many laboratory test results are still highly variable, poorly standardized and harmonized [3]. But analytical variability is the tip of the iceberg, as clinicians and patients require that laboratory tests performed by different laboratories at different times on the same patient can be compared and consistently evaluated. This, in turn, requires not only the comparability of analytical results but also of the ultimate laboratory information; therefore, all other aspects of the total testing process (TTP), such as terminology, sample and specimen quality, units, reference ranges and decision limits, report formats and criteria for interpretation should be harmonized [4, 5]. If the final goal is that patient treatment based on laboratory information is accurate, timely and safe, a global picture of the harmonization process is required. It has been emphasized that “although the brain-to-brain concept is widely accepted by laboratory professionals, there is little clarity concerning the inter-relationship between the different phases of the cycle, in particular the interdependence between the pre-analytical phase and analytical quality, and the role of post-analytical steps in affecting the quality of the ultimate laboratory information provided” [6]. Anything that interferes with any step in the process will be at least a waste and at most a source of errors. This concept has been defined as “the global picture of harmonization in laboratory medicine” which starts from pre-pre-analytical steps, focuses on analytical aspects and finally closes with post-post-analytical issues [4, 5]. The main reasons for focusing on a global picture of harmonization have been already reported [4, 7], but the great progress experienced in the area of harmonization in the last few years persuaded us to publish another special issue of the Journal dedicated to this topic. In particular, the aim of this special issue is not only to report progress of standardization and harmonization initiatives in the traditional area of clinical chemistry but to take into consideration progresses made in other subspecialties such as hematology, coagulation, microbiology, molecular diagnostics as well as in external quality assessment programs, reference values, terminology and units.

The special issue presents a wide range of papers prepared by international experts in the different disciplines in the field of laboratory medicine and is divided into two parts: the first one includes papers describing the initiatives related to harmonization activities from a global perspective and papers dedicated to specific aspects as well (pre-pre analytical, pre-analytical and analytical phases of the TTP); the second one contains papers dedicated to post- and post-post analytical phases.

Section 1. Current harmonization activities at global level. The section lists 11 papers describing: (i) the need to expand the harmonization activities to cover the different subspecialties of laboratory medicine [8]; (ii) the necessity to organize harmonized external quality schemes that include all the branches of the clinical laboratory [9]; (iii) the harmonization activities undertaken by the European Federation of Clinical Chemistry and Laboratory Medicine over the years in Europe and their results as well [10]; (iv) the need of a global approach (IVD companies included) to achieve test standardization/harmonization [11]; (v) the bone turnover in osteoporosis as an example of harmonization of the TTP [12]; the harmonization activities in (vi) hemostasis [13]; (vii) autoimmunity [14]; (viii) microbiology [15]; (ix) the generation and utilization of the biological variation data [16]; and finally, (x) the harmonized and unifying role of the standard ISO15189 [17]; and (xi) the external quality assessment programs and ISO15189 [18].

Section 2. Pre-pre and pre-analytical phases. This section includes two papers: (i) a consensus report from Italy related to the harmonization of the test request in emergency departments [19]; (ii) the EFLM strategy to harmonize the pre-analytical phase [20].

Section 3. Analytical phase. This section lists 17 papers. The first two are related to general activities dedicated to the harmonization and standardization of the clinical laboratory results: (i) a report from the International Consortium for harmonization [21] and (ii) a report from the Dutch Calibration 2.000 program [22]. A number of the articles (n=6) describe the harmonization activities and the respective results (positive or negative) related to a specific test or group of tests: (iii) 17 hydroxyprogesterone [23], (iv) international normalized ratio [24], (v) antithrombin [25], (vi) thiopurine drugs [26], (vii) PCR-based detection of intestinal pathogens [27], (viii) albuminuria [28]. A huge number of papers (n=9) is dedicated to the harmonization of autoimmune testing, starting from (ix) a general perspective of the feasibility of this possibility [29], and continuing with the specific activities addressing specific tests: (x) testing for rheumatic diseases [30], (xi) rheumatoid factor [31], (xii) anti-neutrophil cytoplasmic antibodies [32], (xiii) anti-nuclear antibodies [33], (xiv) autoimmune thyroid diagnostics [34], (xv) anti-nuclear antibodies patterns [35], (xvi) anti-mitochondrial and anti-rods/rings autoantibodies [36]. (xvii) A Letter to the Editor closes this section: it is related to the definition of negative patterns of anti-nuclear antibody testing [37].

Section 4. The post- and post-post analytical phase. The post-analytical part (16 papers) is mainly related to the laboratory report. The first two papers examine the issue from a general point of view: (i) a call for harmony [38] and (ii) a critical analysis on how deep we should go in harmonizing laboratory reports [39]. The following six papers are related to the harmonization of units, terminology and reference intervals: (iii) a Belgian approach to the harmonization of units [40], (iv) a recommendation by the IFCC Committee on reference intervals and decision limits [41], (v) another paper recommending how the clinical laboratory should determine reference intervals in practice [42] and finally three papers reporting on different initiatives on reference intervals, from (vi) Australasia [43], (vii) the Netherlands [44], and (viii) Canada [45]. The next papers inform (ix) about the experience on critical results alert in Australia and New Zealand [46] and (x) about the harmonization in the molecular diagnostics [47]. (xi) An interesting paper from the Italian Society of Clinical Chemistry about the harmonization of interpretative comments in hematology reports is following [48]. The last papers of this section report about the different experience in harmonization of the laboratory report based on external quality assessment activities in (xii) Italy [49] and (xiii) Norway [50], and in (xiv) proficiency testing in hemostasis [51]. The post-post-analytical phase includes two papers: (xv) one about the need of using extra-analytical quality indicators [52] and (xvi) the second one illustrating how laboratory medicine can cooperate with patients and physicians for a better collaborative healthcare [53].

We are confident that this wide range of papers covering all the phases of the TTP of the clinical laboratory and including different branches of laboratory medicine will be useful for the CCLM readership in understanding how we are and where we should go to pursue the pivotal project of harmonization in our discipline with the ultimate goal to assure better outcomes for the patients and the population we serve.

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About the article

Published Online: 2018-07-09

Published in Print: 2018-09-25


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 56, Issue 10, Pages 1559–1562, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0594.

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