Re-engineering laboratory diagnostics for preventing preanalytical errors

Re-engineering laboratory diagnostics for preventing preanalytical errors

CLB-09393; No. of pages: 2; 4C: Clinical Biochemistry xxx (2016) xxx–xxx Contents lists available at ScienceDirect Clinical Biochemistry journal hom...

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CLB-09393; No. of pages: 2; 4C: Clinical Biochemistry xxx (2016) xxx–xxx

Contents lists available at ScienceDirect

Clinical Biochemistry journal homepage: www.elsevier.com/locate/clinbiochem

Editorial

Re-engineering laboratory diagnostics for preventing preanalytical errors Keywords: Errors Laboratory diagnostics Laboratory medicine Preanalytical variability

Medical error is defined as direct or indirect harm to a patient caused by unintended medical acts, failure of planned care activities to be completed as intended, use of the wrong strategy to meet given healthcare expectations, or derangement of a care process [1]. Since medical errors are still the third-leading cause of death for the general population [2], the entire model of care should be re-engineered to reduce the chance of communication breakdowns, poor judgment, inadequate actions and diagnostic errors. Much progress has been made in reducing diagnostic mistakes and enhancing patient safety in recent decades [3]. Nonetheless, in vitro diagnostic testing remains vulnerable to many potential errors, according to the United States Institute of Medicine (IOM)’s latest report in the Quality Chasm series, “Improving Diagnosis in Health Care” [4]. Laboratory diagnostics is not as accurate as it should be. Studies have shown that the majority of laboratory errors are caused by extra-analytical activities, mainly pertaining to collection and handling of biological specimens (the preanalytical phase) and test result transmission or interpretation (the postanalytical phase) [5]. The frequency of analytical errors is often overlooked by physicians and nurses and, regrettably, is also discounted by many other professionals working in clinical laboratories (Fig. 1). Until in vivo diagnostic testing and theranostics passes the validation phase (which is not expected to happen soon) [6], the collection of biological specimens remains an unavoidable part of the diagnostic process. Laboratory errors pose a serious threat to the quality of testing and patient safety, especially when activities are not standardized and regularly monitored. There must be more effort to close the gap between what we know and what we really practice in laboratory diagnostics. This special issue of Clinical Biochemistry is hence devoted to preanalytical issues and their potential impact on the reliability of the laboratory medicine industry as a whole. In the first article in this issue, Adcock and colleagues provide an overview of the many opportunities for errors in hemostasis testing due to preanalytical management of coagulation samples [7]. The authors outline strategies to prevent potential problems in the pre-examination phase and reduce diagnostic errors in patients with potential hemostasis disturbances. The review paper by Bowen and colleagues emphasizes the importance of considering blood collection tubes as genuine medical devices, for which a verification and validation process is mandatory before use [8].

Physical activity is an essential part of human life, not only for maintaining physical and mental fitness, but also for preventing chronic disorders and disabilities. In a comprehensive literature review, Lombardi et al. explore a quite interesting consequence of physical activity [9]. The human organism plastically reacts to physical activity with a natural adaptation response, which profoundly modifies biochemistry and biology. Physical activity should hence be considered as an important preanalytical variable, which may physiologically modify many endogenous responses. In this article, the authors explore the impact of body motions on micro RNAs (miRNAs), short non-coding RNA sequences that are increasingly used for diagnosis, prognostication and therapeutic monitoring of a large number of human diseases. In another article in this issue, Michael Cornes examines interference in laboratory testing, summarizing the various sources of exogenous interference and also providing some potential suggestions to minimize their impact on test results [10]. Delanghe et al. explore the many unresolved issues in preanalytical management of urine samples by reviewing the current guidelines and providing expert guidance on how to best manage this crucial step of urinalysis [11]. The other articles in this issue are devoted to original studies of the impact of preanalytical variables on quality of testing, and may serve as a reliable basis for implementation of safer strategies in daily laboratory practices. These include: • The putative impact of hemolysis on direct bilirubin assessment and expert guidance on how to reduce this bias [12]; • A comparative analysis of circulating tumor DNA stability in different blood collection tubes [13]; • The evaluation of in vivo effect of N-ethylmaleimide (NEM) on assessment of plasma nitrate [14]; • The estimation of imprecision on clinical chemistry testing attributable to fist clenching and maintenance during venipuncture [15]; • The assessment of potential influence of antihypertensive agents on plasma free metanephrines measurement [16]; • The potential interferences of storage time and evacuated blood tubes on amino acid analysis in human blood using ultra-high pressure liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) [17]; • A comparison of quantity, quality and tissue origin of cell-free DNA in maternal plasma and serum using genomic and epigenomic approaches [18]; • An evaluation of the impact of stability of specific IgE antibodies for the diagnosis of common allergies to foods and inhalants [19]; • The impact of sample cooling on temperature-dependent uricolysis due to rasburicase [20];

http://dx.doi.org/10.1016/j.clinbiochem.2016.10.010 0009-9120/© 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Please cite this article as: G. Lippi, et al., Re-engineering laboratory diagnostics for preventing preanalytical errors, Clin Biochem (2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.10.010

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Editorial

Analytical (8-15%) Postanalytical (15-25%)

Preanalytical (60-70%)

Fig. 1. Exploring the iceberg of laboratory errors.

• The impact of automated refrigeration on serum sample stability [21], as well as the effect on test results of different mixing procedures of post-thawed coagulation samples [22]. • The last three articles are devoted to the still-debated issue of glucose stability in plasma using different additives and stabilizers, and their impact on the accurate diagnosis of diabetes [23–25]. We would like to thank all the authors of this special issue of Clinical Biochemistry for their valuable and comprehensive contributions, as well as new insights related to preanalytical issues and variables on laboratory test results. We also hope that you, representing the readership of this journal, find this issue of substantial interest for enhancing both the quality and the safety of laboratory diagnostics. References [1] L.L. Leape, Error in medicine, JAMA 272 (1994) 1851–1857. [2] M.A. Makary, M. Daniel, Medical error-the third leading cause of death in the US, BMJ 353 (2016 May 3) i2139. [3] G. Lippi, M. Plebani, M.L. Graber, Building a bridge to safe diagnosis in health care. The role of the clinical laboratory, Clin. Chem. Lab. Med. 54 (2016) 1–3. [4] National Academies of Sciences, Engineering, and Medicine, Improving Diagnosis in Health Care, The National Academies Press, Washington, DC, 2015. [5] M. Plebani, G. Lippi, To err is human. To misdiagnose might be deadly, Clin. Biochem. 43 (2010) 1–3. [6] G. Lippi, Wisdom of theragnostics, other changes, MLO Med. Lab. Obs. 40 (2008) 6. [7] D.M. Adcock, E.J. Favaloro, G. Lippi, Critical pre-examination variables in the hemostasis laboratory and their quality indicators, Clin. Biochem. (Sep 7 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.08.022 (pii: S0009–9120(16)30240– 5. Epub ahead of print). [8] R.A.R. Bowen, D. Adcock, Blood collection tubes as medical devices: the potential to affect assays and proposed verification and validation processes for the clinical laboratory, Clin Biochem. (Oct 17 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016. 10.004. [9] G. Lombardi, S. Perego, V. Sansoni, G. Banfi, Circulating miRNA as fine regulators of the physiological responses to physical activity: pre-analytical warnings for a novel class of biomarkers, Clin. Biochem. (Sep 27 2016), http://dx.doi.org/10.1016/ j.clinbiochem.2016.09.017 (pii: S0009–9120(16)30335–6. Epub ahead of print). [10] M.P. Cornes, Exogenous sample contamination. Sources and interference, Clin. Biochem. (Sep 20 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.09.014 (pii: S0009–9120(16)30307–1. Epub ahead of print). [11] J. Delanghe, Preanalytics in urinalysis, Clin. Biochem. (2016) (in press). [12] M.S. Devgun, C. Richardson, Direct bilirubin in clinical practice — interpretation and haemolysis interference guidance reassessed, Clin. Biochem. (Sep 7 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.09.005 (pii: S0009–9120(16)30244– 2. Epub ahead of print). [13] Q. Kang, N.L. Henry, C. Paoletti, H. Jiang, P. Vats, A.M. Chinnaiyan, D.F. Hayes, S.D. Merajver, J.M. Rae, M. Tewari, Comparative analysis of circulating tumor DNA stability in K3EDTA, Streck, and CellSave blood collection tubes, Clin. Biochem. (Apr 27 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.03.012 (pii: S0009–9120(16)30040–6. Epub ahead of print). [14] M.A. Mansoor, D.O. Andersen, In vivo effect of N-ethylmaleimide (NEM) on the measurement of nitrate in plasma, Clin. Biochem. (Jul 16 2016), http://dx.doi.org/10. 1016/j.clinbiochem.2016.07.006 (pii: S0009–9120(16)30138–2. Epub ahead of print). [15] G. Lima-Oliveira, G.C. Guidi, G.L. Salvagno, G. Brocco, E. Danese, G. Lippi, Estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture, Clin. Biochem. (Jul 19 2016), http://dx.doi.org/10.1016/j. clinbiochem.2016.07.007 (pii: S0009–9120(16)30141–2. Epub ahead of print).

[16] T.E. Osinga, I.P. Kema, M.N. Kerstens, W.H. de Jong, M. van Faassen, R.P. Dullaart, T.P. Links, A.N. van der Horst-Schrivers, No influence of antihypertensive agents on plasma free metanephrines, Clin. Biochem. (Jun 9 2016), http://dx.doi.org/10.1016/j. clinbiochem.2016.06.004 (pii: S0009–9120(16)30100-X. Epub ahead of print). [17] T. Xia, S. Gao, C. Shu, Y. Wen, Y. Yun, X. Tao, W. Chen, F. Zhang, Analysis of amino acids in human blood using UHPLC-MS/MS: potential interferences of storage time and vacutainer tube in pre-analytical procedure, Clin. Biochem. (Sep 30 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.09.018 (pii: S0009– 9120(16)30345–9. Epub ahead of print). [18] F.C. Wong, K. Sun, P. Jiang, Y.K. Cheng, K.C. Chan, T.Y. Leung, R.W. Chiu, Y.M. Lo, Cellfree DNA in maternal plasma and serum: a comparison of quantity, quality and tissue origin using genomic and epigenomic approaches, Clin. Biochem. (Sep 9 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.09.009 (pii: S0009–9120(16)30255– 7. Epub ahead of print). [19] K. Rodríguez-Capote, K.L. Schnabl, O.R. Maries, P. Janzen, T.N. Higgins, Stability of specific IgE antibodies to common food and inhalant allergens, Clin. Biochem. (Mar 16 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.03.003 (pii: S0009– 9120(16)00093-X. Epub ahead of print). [20] B. Depreter, V. Stove, J. Delanghe, Sampling on ice will not yield reliable uric acid monitoring in rasburicase-treated patients, Clin. Biochem. (Apr 27 2016), http://dx.doi.org/10. 1016/j.clinbiochem.2016.04.011 (pii: S0009–9120(16)30042-X. Epub ahead of print). [21] Improvement in the stability of serum samples stored in an automated refrigerated module, Clin. Biochem. (2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.10.012. [22] G. Lima-Oliveira, D.M. Adcock Funk, G.L. Salvagno, E.J. Favaloro, G. Lippi, Mixing of thawed coagulation samples prior to testing: is any technique better than another? Clin. Biochem. (Oct 18 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.10.009. [23] G. Juricic, A. Saracevic, L.M. Kopcinovic, A. Bakliza, A.M. Simundic, The evidence for clinically significant bias in plasma glucose between liquid and lyophilized citrate buffer additive, Clin. Biochem. (Apr 9 2016), http://dx.doi.org/10.1016/j. clinbiochem.2016.03.006 pii: S00099120(16)300029. Epub ahead of print. [24] R. Carey, H. Lunt, H.F. Heenan, C.M. Frampton, C.M. Florkowski, Collection tubes containing citrate stabiliser over-estimate plasma glucose, when compared to other samples undergoing immediate plasma separation, Clin. Biochem. (May 24 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.05.017 (pii: S0009–9120(16)30067– 4. Epub ahead of print). [25] V. Roccaforte, M. Daves, S. Platzgummer, G. Lippi, The impact of different sample matrices in delayed measurement of glucose, Clin. Biochem. (Aug 25 2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.08.015 (pii: S0009–9120(16)30207– 7. Epub ahead of print).

Giuseppe Lippi Section of Clinical Biochemistry, University of Verona, Verona, Italy Corresponding author at: Section of Clinical Biochemistry, University Hospital of Verona, Piazzale LA Scuro, 37100, Verona, Italy. E-mail addresses: [email protected], [email protected]. Raffick Bowen Clinical Chemistry Service, Department of Pathology, Stanford University Medical Center, Stanford, CA, United States Dorothy M. Adcock Esoterix Inc., Englewood, CO, USA Available online xxxx

Please cite this article as: G. Lippi, et al., Re-engineering laboratory diagnostics for preventing preanalytical errors, Clin Biochem (2016), http://dx.doi.org/10.1016/j.clinbiochem.2016.10.010