JCTLM

Harmonization

Miller WG, Eckfeldt JH, Passarelli J, Young IS. Harmonization of test results: what are the challenges; how can we make it better? Clin Chem 2014; 60: 923-927 https://doi.org/10.1373/clinchem.2012.201186

Miller WG, Myers GL, Gantzer ML, et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 2011; 57:1108-1117 https://doi.org/10.1373/clinchem.2011.164012

Aarsand, A. K., Roraas, T., Bartlett, W. A., Coskun, A., Carobene, A., Fernandez-Calle, P., Jonker, N., Diaz-Garzon, J., Braga, F., Sandberg, S., & Chem, E. F. C. (2018). Harmonization initiatives in the generation, reporting and application of biological variation data. Clinical Chemistry and Laboratory Medicine, 56(10), 1629-1636. https://doi.org/10.1515/cclm-2018-0058  

Armbruster, D., & Donnelly, J. (2016). Harmonization of Clinical Laboratory Test Results: The Role of the IVD Industry. eJIFCC, 27(1), 37-47. https://www.ncbi.nlm.nih.gov/pubmed/27683505  

Arnaud, J., Cote, I., Parsons, P. J., Patriarca, M., Taylor, A., & Weykamp, C. (2014). Harmonization and transferability of performance assessment: experience from four serum aluminum proficiency testing schemes. Accreditation and Quality Assurance, 19(3), 169-174. https://doi.org/10.1007/s00769-014-1049-4  

Aslan, D., Yilmazturk, G. C., Akalin, N., Buyukbese, M. A., Sermez, Y., & Fenkci, S. (2011). Global and national harmonization and standardization of clinical laboratory testings: The example of HbA1c. Turkish Journal of Biochemistry-Turk Biyokimya Dergisi, 36(4), 374-383 https://doi.org/10.1016/j.jmoldx.2019.04.002  

Baadenhuijsen, H., Scholten, R., Willems, H. L., Weykamp, C. W., & Jansen, R. T. (2000). A model for harmonization of routine clinical chemistry results between clinical laboratories. Ann Clin Biochem, 37 ( Pt 3), 330-337. http://www.ncbi.nlm.nih.gov/pubmed/10817247  

Bachmann, L. M., Yu, M., Boyd, J. C., Bruns, D. E., & Miller, W. G. (2017). State of Harmonization of 24 Serum Albumin Measurement Procedures and Implications for Medical Decisions. Clin Chem, 63(3), 770-779. https://doi.org/10.1373/clinchem.2016.262899  

Back, S. E., Nilsson, J. E., Fex, G., Jeppson, J. O., Rosen, U., Tryding, N., von Schenck, H., & Norlund, L. (1999). Towards common reference intervals in clinical chemistry. An attempt at harmonization between three hospital laboratories in Skane, Sweden. Clin Chem Lab Med, 37(5), 573-592. https://doi.org/10.1515/CCLM.1999.091  

Bjerke, M., Andreasson, U., Kuhlmann, J., Portelius, E., Pannee, J., Lewczuk, P., Umek, R. M., Vanmechelen, E., Vanderstichele, H., Stoops, E., Lewis, J., Vandijck, M., Kostanjevecki, V., Jeromin, A., Salamone, S. J., Schmidt, O., Matzen, A., Madin, K., Eichenlaub, U., . . . Blennow, K. (2016). Assessing the commutability of reference material formats for the harmonization of amyloid-beta measurements. Clin Chem Lab Med, 54(7), 1177-1191. https://doi.org/10.1515/cclm-2015-0733  

Burnett, D., & Blair, C. (2001). Standards for he medical laboratory - harmonization and subsidiary. Clin. Chim. Acta, 309, 137-145. http://ac.els-cdn.com/S0009898101005125/1-s2.0-S0009898101005125-main.pdf?_tid=ddd0252e-ca39-11e4-b06a-00000aacb35d&acdnat=1426331241_24f9588b19042a8047a8e88b034e2fd5  

Campbell, C. A., & Horvath, A. R. (2014). Harmonization of critical result management in laboratory medicine. Clinica Chimica Acta, 432, 135-147. https://doi.org/10.1016/j.cca.2013.11.004  

Cavalier, E. (2018). A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (Ctx): A Report from the Ifcc-Iof Working Group for the Standardization of Bone Marker Assays. Osteoporosis International, 29, S120-S121 https://doi.org/10.1007/s00223-021-00816-5  

Cavalier, E., Eastell, R., Jorgensen, N., Tournis, S., Vasikaran, S., Kanis, J. A., Cooper, C., Pottel, H., Makris, K., & Morris, H. (2019). A Multicenter Study to Evaluate Harmonization of Assays for N-Terminal Propeptide of Type I Procollagen (Pinp): A Report from the Ifcc-Iof Working Group for the Standardization of Bone Marker Assays. Osteoporosis International, 30, S532-S532 https://doi.org/10.1515/cclm-2019-0174  

Ceriotti, F., & Cobbaert, C. (2018). Harmonization of External Quality Assessment Schemes and their role - clinical chemistry and beyond. Clin Chem Lab Med, 56(10), 1587-1590. https://doi.org/10.1515/cclm-2018-0265  

Christenson, R. H., Duh, S. H., Apple, F. S., Bodor, G. S., Bunk, D. M., Panteghini, M., Welch, M. J., Wu, A. H., & Kahn, S. E. (2006). Toward standardization of cardiac troponin I measurements part II: assessing commutability of candidate reference materials and harmonization of cardiac troponin I assays. Clin Chem, 52(9), 1685-1692. https://doi.org/10.1373/clinchem.2006.068437  

Church, D. L., & Naugler, C. (2019). Benefits and risks of standardization, harmonization and conformity to opinion in clinical laboratories. Critical Reviews in Clinical Laboratory Sciences, 56(5), 287-306. https://doi.org/10.1080/10408363.2019.1615408  

Clemmons, D. R., Bruns, D. E., & Comm, C. (2011). The Consensus Statement on the Standardization and Evaluation of Growth Hormone and Insulin-like Growth Factor Assays Lacks a Recommendation to Attempt Efficacious Harmonization Reply. Clin Chem, 57(10), 1463-1464. https://doi.org/10.1373/clinchem.2011.170860  

Clerico, A., Ripoli, A., Masotti, S., Prontera, C., Storti, S., Fortunato, A., Buzzi, P., Casagranda, I., Franzini, M., Ndreu, R., Zucchelli, G. C., Zaninotto, M., & Plebani, M. (2016). Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Societa Italiana di Biochimica Clinica (SIBioC). Clin Chim Acta, 456, 42-48. https://doi.org/10.1016/j.cca.2016.02.017  

Clerico, A., Ripoli, A., Zucchelli, G. C., & Plebani, M. (2015). Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the consensus mean value. Clin Chem Lab Med, 53(3), 377-382. https://doi.org/10.1515/cclm-2014-0586  

Cobbaert, C., Smit, N., & Gillery, P. (2018). Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century! Clinical Chemistry and Laboratory Medicine, 56(10), 1598-1602. https://doi.org/10.1515/cclm-2018-0343  

Cobbaert, C., Weykamp, C., Franck, P., de Jonge, R., Kuypers, A., Steigstra, H., Klein Gunnewiek, J., van Loon, D., & Jansen, R. (2012). Systematic monitoring of standardization and harmonization status with commutable EQA-samples--five year experience from the Netherlands. Clin Chim Acta, 414, 234-240. https://doi.org/10.1016/j.cca.2012.09.027  

Cornes, M. P., Church, S., van Dongen-Lases, E., Grankvist, K., Guimaraes, J. T., Ibarz, M., Kovalevskaya, S., Kristensen, G. B., Lippi, G., Nybo, M., Sprongl, L., Sumarac, Z., Simundic, A. M., Working Group for Preanalytical, P., European Federation of Clinical, C., & Laboratory, M. (2016). 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. Ann Clin Biochem, 53(Pt 5), 539-547. https://doi.org/10.1177/0004563216643969  

Cornes, M. P., Church, S., van Dongen-Lases, E., Grankvist, K., Guimaraes, J. T., Ibarz, M., Kovalevskaya, S., Kristensen, G. B. B., Lippi, G., Nybo, M., Sprongl, L., Sumarac, Z., Simundic, A. M., Phase, W. G. P., & Chem, E. F. C. (2016). 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. Ann Clin Biochem, 53(5), 539-547. https://doi.org/10.1177/0004563216643969  

Cox, M. G., Kamvissis, S., Milton, M. J. T., & Vargha, G. (2004). Harmonization of correlated calibration curves with an application to the analysis of natural gases. Advanced Mathematical & Computational Tools in Metrology Vi, 66, 52-66. https://doi.org/Doi 10.1142/9789812702647_0005  

Cwiklinska, A., Dabrowska, H., Kowalski, R., Kuchta, A., Kortas-Stempak, B., Fijalkowska, A., Bednarczuk, G., & Jankowski, M. (2018). Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0102  

Dati, F., & Brand, B. (2000). Standardization activities for harmonization of test results. Clinica Chimica Acta, 297(1-2), 239-249. https://doi.org/10.1016/S0009-8981(00)00250-3   

Dolci, A., & Panteghini, M. (2014). Harmonization of automated hemolysis index assessment and use: Is it possible? Clinica Chimica Acta, 432, 38-43. https://doi.org/10.1016/j.cca.2013.10.012  

Dybkaer, R. (1995a). Harmonization of nomenclature and definitions in reference measurement systems. European Journal of Clinical Chemistry and Clinical Biochemistry, 33(12), 995-998 https://pubmed.ncbi.nlm.nih.gov/8845435/  

Dybkaer, R. (1995b). Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems. Eur J Clin Chem Clin Biochem, 33(12), 995-998. http://www.ncbi.nlm.nih.gov/pubmed/8845435  

Favaloro, E. J., Jennings, I., Olson, J., Van Cott, E. M., Bonar, R., Gosselin, R., & Meijer, P. (2018). Towards harmonization of external quality assessment/proficiency testing in hemostasis. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0077  

Favaloro, E. J., Jennings, I., Olson, J., Van Cott, E. M., Bonar, R., Gosselin, R., & Meijer, P. (2019). Towards harmonization of external quality assessment/proficiency testing in hemostasis. Clinical Chemistry and Laboratory Medicine, 57(1), 115-126. https://doi.org/10.1515/cclm-2018-0077  

Favaloro, E. J., McVicker, W., Zhang, Y., Hamdam, S., Huynh, M., Peris, P., O'Neal, M., & Hocker, N. (2012). Improving the inter-laboratory harmonization of the international normalized ratio (INR): utilizing the concept of transference to estimate and/or validate international sensitivity index (ISI) and mean normal prothrombin time (MNPT) values and/or to eliminate measurement bias. Clin Lab Sci, 25(1), 13-25. http://www.ncbi.nlm.nih.gov/pubmed/22458045  

Favaloro, E. J., Plebani, M., & Lippi, G. (2014a). Standardization and Harmonization of Antiphospholipid Antibody Assays. Semin Thromb Hemost, 40(2), 161-162. https://doi.org/10.1055/s-0033-1364184  

Griffith, L. E., van den Heuvel, E., Raina, P., Fortier, I., Sohel, N., Hofer, S. M., Payette, H., Wolfson, C., Belleville, S., Kenny, M., & Doiron, D. (2016). Comparison of Standardization Methods for the Harmonization of Phenotype Data: An Application to Cognitive Measures. American Journal of Epidemiology, 184(10), 770-778. https://doi.org/10.1093/aje/kww098  

Hansson, L. O., Flodin, M., Larsson, A., Althaus, H., Blirup-Jensen, S., Schmidt, C., Zegers, I., Lindstrom, V., & Grubb, A. (2011). The First Harmonization Step on Cystatin C, with the Aim to Introduce the First Erm-Da471/Ifcc Cystatin C Calibrator and One Worldwide Company-Independent Egfr Equation. Clinical Chemistry and Laboratory Medicine, 49, S557-S557 https://doi.org/10.1515/CCLM.2010.318

Hoffmann, G., Klawonn, F., Lichtinghagen, R., & Orth, M. (2018). No mathematical shortcuts for standardization or harmonization of laboratory measurements Reply. Journal of Laboratory Medicine, 42(1-2), 63-65. https://doi.org/10.1515/labmed-2018-0011  

Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., & Valat, L. (2004). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - part I. Journal of Pharmaceutical and Biomedical Analysis, 36(3), 579-586. https://doi.org/10.1016/j.jpba.2004.07.027  

Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., & Rozet, E. (2007). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part II. Journal of Pharmaceutical and Biomedical Analysis, 45(1), 70-81. https://doi.org/DOI 10.1016/j.jpba.2007.06.013  

Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., & Rozet, E. (2008). Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal Part IV. Examples of application. Journal of Pharmaceutical and Biomedical Analysis, 48(3), 760-771. https://doi.org/DOI 10.1016/j.jpba.2008.07.018  

Hubert, P., Nguyen-Huu, J. J., Boulangerc, B., Chapuzet, E., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., & Rozet, E. (2007). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III. Journal of Pharmaceutical and Biomedical Analysis, 45(1), 82-96. https://doi.org/DOI 10.1016/j.jpba.2007.06.032  

Ichihara, K. (2014). Statistical considerations for harmonization of the global multicenter study on reference values. Clinica Chimica Acta, 432, 108-118. https://doi.org/10.1016/j.cca.2014.01.025  

Jacobs, J. F. M., & Bossuyt, X. (2018). Standardization and harmonization of autoimmune diagnostics. Clinical Chemistry and Laboratory Medicine, 56(10), 1563-1567. https://doi.org/10.1515/cclm-2018-0807  

Johnson, A. M. (2010). Necessity for high-quality reference materials in the harmonization of laboratory assays. Clin Chem Lab Med, 48(6), 747-748. https://doi.org/10.1515/CCLM.2010.180  

Jones, G. R. D. (2017). The role of EQA in harmonization in laboratory medicine - a global effort. Biochemia Medica, 27(1), 23-29. https://doi.org/10.11613/Bm.2017.004  

Kashiwagi, A., Kasuga, M., Araki, E., Oka, Y., Hanafusa, T., Ito, H., Tominaga, M., Oikawa, S., Noda, M., Kawamura, T., Sanke, T., Namba, M., Hashiramoto, M., Sasahara, T., Nishio, Y., Kuwa, K., Ueki, K., Takei, I., Umemoto, M., . . . Soc, J. D. (2012). International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values. Journal of Diabetes Investigation, 3(1), 39-40. https://doi.org/10.1111/j.2040-1124.2012.00207.x  

Kaus, R. (1998). Detection limits and quantitation limits in the view of international harmonization and the consequences for analytical laboratories. Accreditation and Quality Assurance, 3(4), 150-154. https://doi.org/DOI 10.1007/s007690050209  

Keever-Taylor, C. A., Slaper-Cortenbach, I., Celluzzi, C., Loper, K., Aljurf, M., Schwartz, J., McGrath, E., Eldridge, P., & Alliance for Harmonisation of Cellular Therapy, A. (2015). Training practices of cell processing laboratory staff: analysis of a survey by the Alliance for Harmonization of Cellular Therapy Accreditation. Cytotherapy, 17(12), 1831-1844. https://doi.org/10.1016/j.jcyt.2015.08.006  

Khorovskaia, L. A., Kallner, A., & Emanuel, V. L. (2008). [Harmonization in laboratory medicine: a current approach to improving the quality of clinical and laboratory studies]. Klin Lab Diagn(3), 25-32. http://www.ncbi.nlm.nih.gov/pubmed/18450081  

Kilpatrick, E. S., & Sandberg, S. (2018). An overview of EFLM harmonization activities in Europe. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0098  

Klee, G. G. (2010). Harmonization and Standardization of Thyroid Function Tests. Clin Chem, 56(6), 879-880. https://doi.org/10.1373/clinchem.2010.145540  

Koerbin, G., Sikaris, K., Jones, G. R. D., Flatman, R., Tate, J. R., & Intervals, A. H. C. f. C. R. (2018). An update report on the harmonization of adult reference intervals in Australasia. Clin Chem Lab Med, 57(1), 38-41. https://doi.org/10.1515/cclm-2017-0920  

Koerbin, G., Sikaris, K., Jones, G. R. D., Flatman, R., Tate, J. R., & Ref, A. H. C. C. (2019). An update report on the harmonization of adult reference intervals in Australasia. Clinical Chemistry and Laboratory Medicine, 57(1), 38-41. https://doi.org/10.1515/cclm-2017-0920  

Kokshoorn, B., Aarts, L. H. J., Ansell, R., Connolly, E., Drotz, W., Kloosterman, A. D., McKenna, L. G., Szkuta, B., & van Oorschot, R. A. H. (2018). Sharing data on DNA transfer, persistence, prevalence and recovery: Arguments for harmonization and standardization. Forensic Science International-Genetics, 37, 260-269. https://doi.org/10.1016/j.fsigen.2018.09.006  

Lewis, S. M. (1990). Standardization and Harmonization of the Blood-Count - the Role of International Committee for Standardization in Hematology (Icsh). European Journal of Haematology, 45, 9-13 https://doi.org/10.1111/j.1600-0609.1990.tb01520.x   

Lippi, G., Simundic, A. M., European Federation for Clinical, C., & Laboratory Medicine Working Group for Preanalytical, P. (2017). The EFLM strategy for harmonization of the preanalytical phase. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2017-0277  

Massambu, C., & Mwangi, C. (2009). The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system. American journal of clinical pathology, 131(6), 861-866. https://doi.org/10.1309/AJCP3ZAAFUPCIXIG  

McLawhon, R. W. (2011). Patient safety and clinical effectiveness as imperatives for achieving harmonization inside and outside the clinical laboratory. Clin Chem, 57(7), 936-938. https://doi.org/10.1373/clinchem.2011.166041  

Miller, W. G. (2009). The role of proficiency testing in achieving standardization and harmonization between laboratories. Clinical biochemistry, 42(4-5), 232-235. https://doi.org/10.1016/j.clinbiochem.2008.09.004  

Miller, W. G., Eckfeldt, J. H., Passarelli, J., Rosner, W., & Young, I. S. (2013). Harmonization of Test Results: What Are the Challenges; How Can We Make It Better? Clin Chem. https://doi.org/clinchem.2012.20118610.1373/clinchem.2012.201186  

Miller, W. G., Eckfeldt, J. H., Passarelli, J., Rosner, W., & Young, I. S. (2014). Harmonization of Test Results: What Are the Challenges; How Can We Make It Better? Clin Chem, 60(7), 923-927. https://doi.org/10.1373/clinchem.2012.201186  

Miller, W. G., & Greenberg, N. (2021). Harmonization and Standardization: Where Are We Now? J Appl Lab Med, 6(2), 510-521. https://doi.org/10.1093/jalm/jfaa189  

Miller, W. G., Myers, G. L., Ashwood, E. R., Killeen, A. A., Wang, E., Ehlers, G. W., Hassemer, D., Lo, S. F., Seccombe, D., Siekmann, L., Thienpont, L. M., & Toth, A. (2008). State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry. Arch Pathol Lab Med, 132(5), 838-846 https://doi.org/10.5858/2008-132-838-SOTAIT  

Miller, W. G., Myers, G. L., Lou Gantzer, M., Kahn, S. E., Schonbrunner, E. R., Thienpont, L. M., Bunk, D. M., Christenson, R. H., Eckfeldt, J. H., Lo, S. F., Nubling, C. M., & Sturgeon, C. M. (2011). Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem, 57(8), 1108-1117. https://doi.org/10.1373/clinchem.2011.164012  

Mitani, Y., Lara-Manzano, J. V., & Rodriguez-Lopez, A. (2008). Proficiency testing scheme for the harmonization and comparability of analytical measurements. Accreditation and Quality Assurance, 13(7), 421-426. https://doi.org/10.1007/s00769-008-0398-2  

Myara, A., Guechot, J., Imbert-Bismut, F., Lasnier, E., Piton, A., Voitot, H., & Ferard, G. (2004). Harmonization of liver enzyme results: calibration for aminotransferases and gamma glutamyltransferase. J Hepatol, 41(3), 501-502. https://doi.org/10.1016/j.jhep.2004.04.036  

Myers, G. L., & Miller, W. G. (2016). The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) - A Pathway for Harmonization. eJIFCC, 27(1), 30-36. https://www.ncbi.nlm.nih.gov/pubmed/27683504

Myers, G. L., & Miller, W. G. (2018). The roadmap for harmonization: status of the International Consortium for Harmonization o Clinical Laboratory Results. Clinical Chemistry and Laboratory Medicine, 56(10), 1667-1672. https://doi.org/10.1515/cclm-2017-0907  

Netzel, B. C., Grant, R. P., Hoofnagle, A. N., Rockwood, A. L., Shuford, C. M., & Grebe, S. K. G. (2016). First Steps toward Harmonization of LC-MS/MS Thyroglobulin Assays. Clin Chem, 62(1), 297-299. https://doi.org/10.1373/clinchem.2015.245266  

Padoan, A., Clerico, A., Zaninotto, M., Trenti, T., Tozzoli, R., Aloe, R., Alfano, A., Rizzardi, S., Dittadi, R., Migliardi, M., Bagnasco, M., & Plebani, M. (2020). Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2019-1167  

Pamukcuoglu, M., Falay, M., Urlu, S. M., Ucar, M. A., Ceren, F., Dagdas, S., & Ozet, G. (2017). What We Can Do to Make a Standardization and Harmonization of Aptt? Haematologica, 102, 830-830 https://library.ehaweb.org/eha/2017/22nd/182803/merve.what.we.can.do.to.make.a.standardization.and.harmonization.of.aptt.html  

Plebani, M. (2013). Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med, 51(4), 741-751. https://doi.org/10.1515/cclm-2013-0075  

Plebani, M. (2015). Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci, 1-13. https://doi.org/10.3109/10408363.2015.1116851  

Plebani, M. (2016). Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci, 53(3), 184-196. https://doi.org/10.3109/10408363.2015.1116851  

Plebani, M. (2018). Harmonization in laboratory medicine: more than clinical chemistry? Clinical Chemistry and Laboratory Medicine, 56(10), 1579-1586. https://doi.org/10.1515/cclm-2017-0865  

Plebani, M., Astion, M. L., Barth, J. H., Chen, W., de Oliveira Galoro, C. A., Escuer, M. I., Ivanov, A., Miller, W. G., Petinos, P., Sciacovelli, L., Shcolnik, W., Simundic, A. M., & Sumarac, Z. (2014). Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med, 52(7), 951-958. https://doi.org/10.1515/cclm-2014-0142  

Plebani, M., Chiozza, M. L., & Sciacovelli, L. (2013). Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med, 51(1), 187-195. https://doi.org/10.1515/cclm-2012-0582  

Plebani, M., Sciacovelli, L., Aita, A., & Chiozza, M. L. (2014). Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb), 24(1), 105-113. https://doi.org/10.11613/BM.2014.012  

Rami, L., Roura, M., & Canalias, F. (2012). Evaluation of commutability of several materials for harmonization alkaline phosphatase catalytic concentration measurements. Clin Chim Acta, 413(15-16), 1249-1254. https://doi.org/10.1016/j.cca.2012.04.004  

Royal, P. D. (1994). Harmonization of good laboratory practice requirements and laboratory accreditation programs. Qual Assur, 3(3), 312-315. http://www.ncbi.nlm.nih.gov/pubmed/7804653  

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