Harmonising EQA schemes the next frontier: challenging the status quo
-
Tony Badrick
and
Anne Stavelin
Abstract
There is a focus on standardisation and harmonisation of laboratory results to reduce the risk of misinterpretation of patient results assayed in different laboratories. External quality assessment (EQA) is critical to assess the need for harmonisation and to monitor the success of procedures to achieve harmonisation. However, EQA providers are being stretched to meet the needs of their participants with proven commutable material with reference method targets, a range of clinically significant levels of the materials, detailed and customised data analysis, and educational support. The path ahead for harmonisation of EQA schemes will require leadership from an organisation that has the support and confidence of EQA providers, like the European Organisation for External Qualily Assurance Providers in Laboratory Medicine.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: Authors state no conflict of interest.
References
1. Miller WG. The standardization journey and the path ahead. J Lab Precis Med 2019;3. doi: 10.21037/jlpm.2018.09.14.10.21037/jlpm.2018.09.14Search in Google Scholar
2. Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741–51.10.1515/cclm-2013-0075Search in Google Scholar PubMed
3. Plebani M. Harmonization in laboratory medicine: more than clinical chemistry? Clin Chem Lab Med 2018;56:1579–86.10.1515/cclm-2017-0865Search in Google Scholar PubMed
4. Tate JR, Sikaris KA, Jones GR, Yen T, Koerbin G, Ryan J, et al. Harmonising adult and paediatric reference intervals in Australia and New Zealand: an evidence-based approach for establishing a first panel of chemistry analytes. Clin Biochem Rev 2014;35:213–35.Search in Google Scholar
5. Jones G, Albarede S, Kesseler D, MacKenzie F, Mammen J, Pedersen M, et al. Analytical performance specifications for external quality assessment – definitions and descriptions. Clin Chem Lab Med 2017;55:949–55.10.1515/cclm-2017-0151Search in Google Scholar PubMed
6. Miller WG, Schimmel H, Rej R, Greenberg N, Ceriotti F, Burns C, et al. IFCC Working Group Recommendations for Assessing Commutability Part. Part 1: General experimental design. Clin Chem 2018;64;447–54.10.1373/clinchem.2017.277525Search in Google Scholar PubMed PubMed Central
7. Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC Working Group Recommendations for Assessing Commutability. Part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64.10.1373/clinchem.2017.277541Search in Google Scholar PubMed PubMed Central
8. Braga F, Pasqualetti S, Panteghini P. The role of external quality assessment in the verification of in vitro medical diagnostics in the traceability era. Clin Biochem 2018;57:23–8.10.1016/j.clinbiochem.2018.02.004Search in Google Scholar PubMed
9. Ceriotti F. The role of External Quality Assessment Schemes in Monitoring and Improving the Standardization Process. Clin Chim Acta 2014;432:77–81.10.1016/j.cca.2013.12.032Search in Google Scholar PubMed
10. Stavelin A, Albe X, Meijer P, Sarkany E, MacKenzie F. An overview of the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM). Biochem Med (Zagreb) 2017;27:30–6.10.11613/BM.2017.005Search in Google Scholar PubMed PubMed Central
11. Jansen R, Jassam N, Thomas A, Perich C, Fernandez-Calle P, Faria AP, et al. A category 1 EQA scheme for comparison of laboratory performance and method performance: an international pilot study in the framework of the Calibration 2000 project. Clin Chim Acta 2014;432:90–8.10.1016/j.cca.2013.11.003Search in Google Scholar PubMed
12. Perich C, Ricós C, Alvarez V, Biosca C, Boned B, Cava F, et al. External quality assurance programs as a tool for verifying standardization of measurement procedures: pilot collaboration in Europe. Clin Chim Acta 2014;432:82–9.10.1016/j.cca.2013.11.005Search in Google Scholar PubMed
13. Stavelin A, Riksheim BO, Christensen NG, Sandberg S. The importance of reagent lot registration in external quality assurance/proficiency testing schemes. Clin Chem 2016;62:708–15.10.1373/clinchem.2015.247585Search in Google Scholar PubMed
14. Jones GR. The role of EQA in harmonization in laboratory medicine – a global effort. Biochem Med (Zagreb) 2017;27:23–9.10.11613/BM.2017.004Search in Google Scholar PubMed PubMed Central
15. Pasqualetti S, Infusino I, Carnevale A, Szőke D, Panteghini M. The calibrator value assignment protocol of the Abbott enzymatic creatinine assay is inadequate for ensuring suitable quality of serum measurements. Clin Chim Acta 2015;450:125–6.10.1016/j.cca.2015.08.007Search in Google Scholar PubMed
16. Myers G, Miller W. The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results. Clin Chem Lab Med 2018;56:1667–72.10.1515/cclm-2017-0907Search in Google Scholar PubMed
17. Miller WG. Harmonization: its time has come. Clin Chem 2017;63:1184–6.10.1373/clinchem.2017.274860Search in Google Scholar PubMed
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