Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach
-
Giorgia Antonelli
,
Andrea Padoan
Abstract
Background
The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2.
Methods
In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers.
Results
The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods.
Conclusions
The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.
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.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. International Organization for Standardization (ISO). Medical laboratories-particular requirements for quality and competence. ISO 15189, Geneva, Switzerland, 2012.Search in Google Scholar
2. Farmer T. Toward a culture shift in laboratory quality: application of the full ISO 15189 standard. MLO Med Lab Obs 2015;47:38–9.Search in Google Scholar
3. Plebani M, Sciacovelli L, Chiozza ML, Panteghini M. Once upon a time: a tale of ISO 15189 accreditation. Clin Chem Lab Med 2015;53:1127–9.10.1515/cclm-2015-0355Search in Google Scholar PubMed
4. EU Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1998). Available at: www.europa.eu/legislation_summaries/internal_market/single_market_for_goods/technical_harmonisation/l21010c_en.htmSearch in Google Scholar
5. Clinical Pathology Accreditation (UK). Standards for Medical Laboratory. Version 2.01, CPA, UK, March 2009.Search in Google Scholar
6. International Organization for Standardization (ISO). Quality management system. Geneva, Switzerland, ISO 9001:2008.Search in Google Scholar
7. Eurachem: a focus for analytical chemistry in Europe. The fitness for purpose of analytical methods: a laboratory guide to method validation and related topics, 2nd ed. Eurachem, Prague, Czech Republic, 2014.Search in Google Scholar
8. International Organization for Standardization (ISO). Guide to the use of repeatability, reproducibility, and trueness estimates in measurement uncertainty estimation. ISO/DTS 21748, Geneva, Switzerland, 2002.Search in Google Scholar
9. Ente italiano di accreditamento (Accredia). Guide to perform tests with qualitative results. Accredia DT-07-DL/DS, Milan, Italy, 2013. [in Italian]Search in Google Scholar
10. Sistema nazionale per l’accreditamento di laboratori (SINAL). Guida al calcolo della ripetibilità di un metodo di prova ed alla sua verifica nel tempo. SINAL DT-0002/6, Milan, Italy, 2007. [in Italian]Search in Google Scholar
11. European Medicines Agency (EMA). Guideline on bioanalytical method validation. London, UK, 2011.Search in Google Scholar
12. U.S. Food and Drug Administration (U.S. FDA). Guidance for industry: bionalytical method validation; draft guidance. Silver Springs, MD, 2013.Search in Google Scholar
13. Agenzia Regionale per la Protezione Ambientale Campana (ARPAC). Validazione metodi di prova chimici. Naples, Italy, 2008. [in Italian]Search in Google Scholar
14. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Validation of Analytical procedures: text and methodology Q2 (R1). Geneva, Switzerland, 2005.Search in Google Scholar
15. Clinical and Laboratory Standards Institute (CLSI). Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline, 3rd ed. CLSI EP10, Wayne, PA, USA, 2010.Search in Google Scholar
16. Rios A, Barcelò D, Buydens L, Cardenas S. Quality assurance of qualitative analysis in the framework of the European project “MEQUALAN.” Accred Qual Assur 2003;8:68–77.10.1007/s00769-002-0556-xSearch in Google Scholar
17. International Union of Pure and Applied Chemistry (IUPAC). Harmonized guidelines for single laboratory validation of methods of analysis. IUPAC technical report. Pure Appl Chem 2002;74:835–55.10.1351/pac200274050835Search in Google Scholar
18. Clinical and Laboratory Standards Institute (CLSI). User protocol for evaluation of qualitative test performance; approved guideline, 2nd ed. CLSI EP12, Wayne, PA, USA, 2008.Search in Google Scholar
19. Clinical and Laboratory Standards Institute (CLSI). User verification of precision and estimation of bias; approved guideline, 3rd ed. CLSI EP15, Wayne, PA, USA, 2014.Search in Google Scholar
20. Clinical and Laboratory Standards Institute (CLSI). Establishing molecular testing in clinical laboratory environments; approved guideline. CLSI MM19, Wayne, PA, USA, 2011.Search in Google Scholar
21. Clinical and Laboratory Standards Institute (CLSI). Statistical quality control for quantitative measurement procedures; approved guideline, 3rd ed. CLSI C24, Wayne, PA, USA, 2006.Search in Google Scholar
22. Clinical and Laboratory Standards Institute (CLSI). Evaluation of precision performance of quantitative measurement methods; approved standard, 2nd ed. CLSI EP05, Wayne, PA, USA, 2013.Search in Google Scholar
23. Clinical and Laboratory Standards Institute (CLSI). Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. CLSI EP06, Wayne, PA, USA, 2003.Search in Google Scholar
24. Clinical and Laboratory Standards Institute (CLSI). Interference testing in clinical chemistry; approved guideline, 2nd ed. CLSI EP07, Wayne, PA, USA, 2005.Search in Google Scholar
25. Clinical and Laboratory Standards Institute (CLSI). Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline, 2nd ed. CLSI EP17, Wayne, PA, USA, 2012.Search in Google Scholar
26. Clinical and Laboratory Standards Institute (CLSI). Evaluation of matrix effects; approved guideline, 3rd ed. CLSI EP14, Wayne, PA, USA, 2014.Search in Google Scholar
27. Clinical and Laboratory Standards Institute (CLSI). Evaluation of stability of in vitro diagnostic method products; approved guideline. CLSI EP25, Wayne, PA, USA, 2009.Search in Google Scholar
28. Clinical and Laboratory Standards Institute (CLSI). Validation, verification, and quality assurance of automated hematology analyzers; approved guideline, 2nd ed. CLSI H26, Wayne, PA, USA, 2014.Search in Google Scholar
29. Clinical and Laboratory Standards Institute (CLSI). Molecular methods for clinical genetics and oncology testing; approved guideline, 3rd ed. CLSI MM01, Wayne, PA, USA, 2012.Search in Google Scholar
30. Ente italiano di accreditamento (Accredia). General criteria for the accreditation of medical laboratories. DT-06, Milan, Italy, 2010. [in Italian]Search in Google Scholar
31. Fraser CG. The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine. Clin Chem Lab Med 2015;53:837–40.10.1515/cclm-2014-0914Search in Google Scholar PubMed
32. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the european federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med 2015;53:833–5.10.1515/cclm-2015-0067Search in Google Scholar PubMed
33. Skendzel LP, Barnett RN, Platt R. Medically useful criteria for analytic performance of laboratory tests. Am J Clin Pathol 1985;83:200–5.10.1093/ajcp/83.2.200Search in Google Scholar PubMed
34. Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010;56:714–22.10.1373/clinchem.2009.133660Search in Google Scholar PubMed
35. Stöckl D, D’Hondt H, Thienpont LM. Method validation across the disciplines–critical investigation of major validation criteria and associated experimental protocols. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:2180–90.10.1016/j.jchromb.2008.12.056Search in Google Scholar PubMed
36. Wilson EB. “Probable inference, the law of succession, and statistical inference.” J Am Stat Assoc 1927;22:209–12.10.1080/01621459.1927.10502953Search in Google Scholar
37. Vasikaran S, Sikaris K, Kilpatrick E, French J, Badrick T, Osypiw J, et al. Assuring the quality of interpretative comments in clinical chemistry. Clin Chem Lab Med 2016;54:1901–11.10.1515/cclm-2016-0709Search in Google Scholar PubMed
38. Theodorsson E. Validation and verification of measurement methods in clinical chemistry. Bioanlysis 2012;4:305–20.10.4155/bio.11.311Search in Google Scholar PubMed
39. 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
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- Frontmatter
- Editorials
- Reporting LDL-cholesterol levels in the era of intensive lipid management: a clarion call
- The challenges of genetic risk scores for the prediction of coronary heart disease
- Reviews
- Advanced lipoprotein testing for cardiovascular diseases risk assessment: a review of the novel approaches in lipoprotein profiling
- A review of the challenge in measuring and standardizing BCR-ABL1
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- Challenges in the analysis of epigenetic biomarkers in clinical samples
- Opinion Paper
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- Assessment of EGFR mutation status using cell-free DNA from bronchoalveolar lavage fluid
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- A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry
- Practical motives are prominent in test-ordering in the Emergency Department
- Technical and clinical validation of the Greiner FC-Mix glycaemia tube
- Comparison of pneumatic tube system with manual transport for routine chemistry, hematology, coagulation and blood gas tests
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- Analytical performance and diagnostic accuracy of six different faecal calprotectin assays in inflammatory bowel disease
- Novel immunoassays for detection of CUZD1 autoantibodies in serum of patients with inflammatory bowel diseases
- Hematology and Coagulation
- Critical appraisal of discriminant formulas for distinguishing thalassemia from iron deficiency in patients with microcytic anemia
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- Reference ranges of thromboelastometry in healthy full-term and pre-term neonates
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- Immunoparesis in IgM gammopathies as a useful biomarker to predict disease progression
- Cardiovascular Diseases
- Assessment of the clinical utility of adding common single nucleotide polymorphism genetic scores to classical risk factor algorithms in coronary heart disease risk prediction in UK men
- Time and age dependent decrease of NT-proBNP after septal myectomy in hypertrophic obstructive cardiomyopathy
- Infectious Diseases
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- Sensitivity of the Sysmex XN9000 WPC-channel for detection of monoclonal B-cell populations
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