Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
-
Christoph Buchta
,
Wim Coucke
Abstract
Background
ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services. Although widely used, their impact on laboratory performance has not been investigated.
Methods
We retrospectively analysed the results of 167 laboratories in 59 distributions of the Austrian red cell immunohaematology external quality assessment (EQA) scheme in the years 1999–2017. The performance for each parameter and trends of individual participants were compared with respect to certification or accreditation status of participants’ quality systems and to laboratory type.
Results
Considering more than 52,000 EQA results, the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p=0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%).
Conclusions
Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results. The conclusion is that these results apply to other laboratory tests and perhaps to other areas of health care.
Acknowledgements
The authors gratefully acknowledge Astrid Radakovics and Michaela Gökler for their special effort and help in collecting and restoring data from archives, and Ursula Fentler who has tirelessly requested certification/accreditation status and dates of participants.
Author contributions: CB, WC, and RO designed the study. CB collected data and searched the literature. CB and WC analysed and interpreted data. CB, WC, CRS, and GFK drafted the manuscript. WRM, MMM, and GFK revised the paper. 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. Quality management systems – requirements (ISO 9001:2015). Geneva: International Organization for Standardization (ISO), 2015.Search in Google Scholar
2. Medical laboratories – requirements for quality and competence (ISO 15189:2012). Geneva: International Organization for Standardization (ISO), 2012.Search in Google Scholar
3. Quality management systems – fundamentals and vocabulary (ISO 9000:2015). Geneva: International Organization for Standardization (ISO), 2015.Search in Google Scholar
4. Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med 2017;37:365–70.10.3343/alm.2017.37.5.365Search in Google Scholar PubMed PubMed Central
5. Pereira P, Westgard JO, Encarnacao P, Seghatchian J, de Sousa G. Quality management in Europe screening laboratories in blood establishments: a view of current approaches and trends. Transfus Apher Sci 2015;52:245–51.10.1016/j.transci.2015.02.014Search in Google Scholar PubMed
6. Sciacovelli L, Aita A, Padoan A, Antonelli G, Plebani M. ISO 15189 accreditation and competence: a new opportunity for laboratory medicine. J Lab Precis Med 2017;2:79–83.10.21037/jlpm.2017.09.05Search in Google Scholar
7. Lidbury BA, Koerbin G, Richardson AM, Badrick T. Integration of ISO 15189 and external quality assurance data to assist the detection of poor laboratory performance in NSW, Australia. J Lab Precis Med 2017;2:97.10.21037/jlpm.2017.12.01Search in Google Scholar
8. Bundesgesetz über Krankenanstalten und Kuranstalten (KAKuG), BGBl. Nr. 1/1957.Search in Google Scholar
9. Bundesgesetz über die Ausübung des ärztlichen Berufes und die Standesvertretung der Ärzte (ÄrzteG) BGBl. I Nr. 169/1998.Search in Google Scholar
10. Qualitätssicherung in medizinischen Laboratorien (ÖNORM K 1950:2015). Vienna: Austrian Standards, 2015.Search in Google Scholar
11. ÖGBT Standards – Immunhämatologische Untersuchungen bei Patienten. Vienna: Österreichische Gesellschaft für Blutgruppenserologie, Transfusionsmedizin, Regenerative Medizin und Immungenetik, 2015.Search in Google Scholar
12. https://isotc.iso.org/livelink/livelink?func=ll&objId=18808772&objAction=browse&viewType=1; accessed on Jan 18 2018.Search in Google Scholar
13. Guzel O, Guner EI. ISO 15189 Accreditation: requirements for quality and competence of medical laboratories, experiences of a laboratory I. Clin Biochem 2009;42:274–8.10.1016/j.clinbiochem.2008.09.011Search in Google Scholar PubMed
14. Badrick T. Evidence-based laboratory medicine. Clin Biochem Rev 2013;34:43–6.Search in Google Scholar
15. Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem 2013;46:1170–4.10.1016/j.clinbiochem.2012.11.028Search in Google Scholar PubMed
16. Statistical methods for use in proficiency testing by interlaboratory comparison (ISO 13528:2015). Geneva: International Organization for Standardization (ISO), 2015.Search in Google Scholar
17. Plebani M. Errors in laboratory medicine and patient safety: the road ahead. Clin Chem Lab Med 2007;45:700–7.10.1515/CCLM.2007.170Search in Google Scholar PubMed
18. James D, Ames D, Lopez B, Still R, Simpson W, Twomey P. External quality assessment: best practice. J Clin Pathol 2014;67:651–5.10.1136/jclinpath-2013-201621Search in Google Scholar PubMed
19. Vesper HW, Miller WG, Myers GL. Reference materials and commutability. Clin Biochem Rev 2007;28:139–47.Search in Google Scholar
20. Reference materials – guidance for characteristics and assessment of homogeneity and stability (ISO Guide 35). Geneva: International Organization for Standardization (ISO), 2017.Search in Google Scholar
21. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986;73:13–22.10.1093/biomet/73.1.13Search in Google Scholar
22. Pinkerton PH, Wood DE, Burnie KL, Carstairs KC, Croucher BE, Ezer SC, et al. Proficiency testing in immunohaematology in Ontario, Canada, 1977–79. Clin Lab Haematol 1981;3:155–64.10.1111/j.1365-2257.1981.tb01325.xSearch in Google Scholar PubMed
23. Holburn AM, Prior DM, Whitton CM. The UK National External Quality Assessment Scheme in Blood Group Serology. ABO and D grouping, antibody screening, direct antiglobulin test and antibody identification 1984–1985. Clin Lab Haematol 1988;10:73–85.10.1111/j.1365-2257.1988.tb01155.xSearch in Google Scholar PubMed
24. Brener S, Ferreira AM, de Carvalho RV, do Valle MC, Souza HM. Assessment of performance of professionals in immunohematology proficiency tests of the public blood bank network of the state of Minas Gerais. Rev Bras Hematol Hemoter 2012;34:80–5.10.5581/1516-8484.20120027Search in Google Scholar PubMed PubMed Central
©2018 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Observing an analyzer’s operational life cycle: a useful management tool for clinical laboratories
- Reviews
- Personalized laboratory medicine: a patient-centered future approach
- Circular RNAs: a new class of biomarkers as a rising interest in laboratory medicine
- Mini Review
- Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review
- Opinion Paper
- Uncertainty in measurement and total error: different roads to the same quality destination?
- Guidelines and Recommendations
- Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
- General Clinical Chemistry and Laboratory Medicine
- Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
- Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial
- Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements
- Failure rate prediction of equipment: can Weibull distribution be applied to automated hematology analyzers?
- Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
- Increased serum concentrations of soluble ST2 predict mortality after burn injury
- The clinical significance of borderline results of the Elia CTD Screen assay
- Reference Values and Biological Variations
- Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
- Cancer Diagnostics
- BCL2L12 improves risk stratification and prediction of BFM-chemotherapy response in childhood acute lymphoblastic leukemia
- Cardiovascular Diseases
- The correlation between glucose fluctuation from self-monitored blood glucose and the major adverse cardiac events in diabetic patients with acute coronary syndrome during a 6-month follow-up by WeChat application
- Diabetes
- Impact of blood cell counts and volumes on glucose concentration in uncentrifuged serum and lithium-heparin blood tubes
- Letters to the Editor
- Standard process-oriented workflow introduces pre-analytical error when used in large study sample batches
- Comparison of three staining methods in the automated digital cell imaging analyzer Sysmex DI-60
- Detection of Plasmodium falciparum using automated digital cell morphology analyzer Sysmex DI-60
- Serum ischemia-modified albumin concentration may reflect long-term hypoxia in chronic respiratory disease: a pilot study
- Wet absorptive microsampling at home for HbA1c monitoring in diabetic children
- Serum endocan levels in patients with chronic obstructive pulmonary disease: a potential role in the evaluation of susceptibility to exacerbation
- Analytical and clinical validation of the new Roche Elecsys Vitamin D Total II assay
- Analytical validation of two second generation thyroglobulin immunoassays (Roche and Thermo Fisher)
- Omission of preservatives during 24-h of urine collection for the analysis of fractionated metanephrines enhance patient convenience
- Transient monoclonal gammopathy in a 2-year-old child with combined viral and bacterial infection
- Nephelometric assay of urine free light chains: an alternative and early clinical test for Bence-Jones protein quantification
- Congress Abstracts
- Congress of Laboratory Medicine and Clinical Chemistry 7th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
- 50th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
- Revolution drives Evolution – from measuring to understanding: Annual meeting of Swiss Society of Clinical Chemistry (SSCC) in Bern, November 15-16 2018
