A computer model for professional competence assessment according to ISO 15189

Claudia Bellini; Francesca Cinci; Carlo Scapellato; Roberto Guerranti

doi:10.1515/cclm-2019-1018

Article

A computer model for professional competence assessment according to ISO 15189

Claudia Bellini , Francesca Cinci , Carlo Scapellato and Roberto Guerranti

Published/Copyright: February 24, 2020

Published by

Become an author with De Gruyter Brill

Submit Manuscript Author Information

From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 58 Issue 8

Abstract

Background

As defined by ISO 15189 competence is the “demonstrated ability to apply knowledge and skills” thus, its assessment is fundamental for ensuring the quality of the total testing process in order to reduce the risk for the patient. We have developed a functional software for the measurement of professional competences in order to standardize the procedure and to collect all the data in a single platform, avoiding redundancy and dispersion.

Methods

Our model objectively assesses the skills, as they become measurable and comparable with appropriate standards and involves both managers and operators, to increase their active engagement. The assessment concerns everyone, but the standards to be met (numerical values) can vary according to the responsibilities. Several subjective and objective criteria are evaluated: each parameter can contribute in a variable proportion to the total skills measured according to the needs of the organization.

Results

The data are automatically analyzed and can be easily monitored in real time in the form of indicators, thanks to dashboards. The comparison between the skills required and those measured allows highlighting the gap useful for planning personalized training paths.

Conclusions

Our tool is reliable and highly adaptable to laboratories about competences to track criteria, standards and monitored indicators. The computerized management is a strategic action as it fulfills the requirements of registration, traceability, communication, data analysis and indicators development, which are the tenets of continuous improvement, and allows planning to be made on the basis of the actual training needs.

Keywords: accreditation; computer model; ISO 15189; laboratory competence; medical education; quality assessment; quality indicators

Corresponding author: Claudia Bellini, MD, Medical Biotechnologies Department, University of Siena, Siena, Italy; and Clinical Pathology Unit, Innovation, Experimentation and Clinical and Translational Research Department, University Hospital of Siena, 53100 Siena, Italy

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. Plebani M, Laposata M, Lippi G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta 2019;489:49–52.10.1016/j.cca.2018.11.021Search in Google Scholar PubMed

2. Hallworth MJ. The ‘70% claim’: what is the evidence base? Ann Clin Biochem 2011;48:487–8.10.1258/acb.2011.011177Search in Google Scholar PubMed

3. Sikaris KA. Enhancing the clinical value of medical laboratory testing. Clin Biochem Rev 2017;38:107–14.Search in Google Scholar

4. Plebani M, Lippi G. Is laboratory medicine a dying profession? Blessed are those who have not seen and yet have believed. Clin Biochem 2010;43:939–41.10.1016/j.clinbiochem.2010.05.015Search in Google Scholar PubMed

5. Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf 2013;22:ii6–10.10.1136/bmjqs-2012-001621Search in Google Scholar PubMed PubMed Central

6. Beastall GH. Adding value to laboratory medicine: a professional responsibility. Clin Chem Lab Med 2013;51:221–7.10.1515/cclm-2012-0630Search in Google Scholar PubMed

7. Burnett D. A practical guide to ISO 15189 in laboratory medicine. London: ACB Venture Publications, 2013.Search in Google Scholar

8. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53:1338–42.10.1373/clinchem.2007.088344Search in Google Scholar PubMed

9. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;43:1348–51.10.1093/clinchem/43.8.1348Search in Google Scholar

10. 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

11. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136:829–33.10.1309/AJCPR28HWHSSDNONSearch in Google Scholar PubMed

12. International Organization for Standardization. ISO 15189:2012: Medical Laboratories: Particular Requirements for Quality and Competence. Geneva, Switzerland: International Organization for Standardization, 2012.Search in Google Scholar

13. Frank JR, Mungroo R, Ahmad Y, Wang M, De Rossi S, Horsley T. Toward a definition of competency-based education in medicine: a systematic review of published definitions. Med Teach 2010;32:631–7.10.3109/0142159X.2010.500898Search in Google Scholar PubMed

14. Wallace S, May SA. Assessing and enhancing quality through outcomes-based continuing professional development (CPD): a review of current practice. Vet Rec 2016;179:515–20.10.1136/vr.103862Search in Google Scholar PubMed PubMed Central

15. Miller GE. The assessment of clinical skills/competence/performance. Acad Med 1990;65:S63–7.10.1097/00001888-199009000-00045Search in Google Scholar PubMed

16. McCloskey CB, Domen RE, Conran RM, Hoffman RD, Post MD, Brissette MD, et al. Entrustable professional activities for pathology: recommendations from the College of American Pathologists Graduate Medical Education Committee. Acad Pathol 2017;4:1–9.10.1177/2374289517714283Search in Google Scholar PubMed PubMed Central

17. CLSI. Training and competence assessment, 4th ed. CLSI guideline QMS03. Wayne, PA: Clinical and Laboratory Standards Institute, 2016.Search in Google Scholar

18. CLSI. Laboratory personnel management, 1st ed. CLSI guideline QMS16. Wayne, PA: Clinical and Laboratory Standards Institute, 2015.Search in Google Scholar

19. Plebani M, Lippi G. Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine. Clin Chem Lab Med 2016;54:1117–8.10.1515/cclm-2016-0217Search in Google Scholar PubMed

20. Kricka LJ, Polsky TG, Park JY, Fortina P. The future of laboratory medicine – a 2014 perspective. Clin Chim Acta 2015;438: 284–303.10.1016/j.cca.2014.09.005Search in Google Scholar PubMed

21. Beastall G, Kenny D, Laitinen P, ten Kate J. A guide to defining the competence required of a consultant in clinical chemistry and laboratory medicine. Clin Chem Lab Med 2005;43:654–9.10.1515/CCLM.2005.112Search in Google Scholar PubMed

22. Recommended standards for training specialists in laboratory medicine/medical biopathology. http://www.uems-slm.org/uems/01-PDF/BB_2012May_Final.pdf. Accessed: 12 Sep 2019.Search in Google Scholar

23. Oosterhuis WP, Zerah S. Laboratory medicine in the European Union. Clin Chem Lab Med 2015;53:5–14.10.1515/cclm-2014-0407Search in Google Scholar PubMed

24. Zerah S, McMurray J, Horvath AR. Our profession now has a European name: specialist in laboratory medicine. Biochem Med (Zagreb) 2012;22:272–3.10.11613/BM.2012.029Search in Google Scholar

25. Jassam N, Lake J, Dabrowska M, Queralto J, Rizos D, Lichtinghagen R, et al. The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 – 2018. Clin Chem Lab Med 2018;56:1846–63.10.1515/cclm-2018-0344Search in Google Scholar PubMed

26. Greaves AU, Smith JM, Greaves SE, Florkowski C, Langman L, Sheldon J, et al. The IFCC curriculum. 2017. http://www.ifcc.org/media/477173/2017-ifcc-curriculum.pdf. Accessed: 12 Sep 2019.Search in Google Scholar

27. CMS What Do I Need to Do to Assess Personnel Competency? 2012 Nov. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf. Accessed: 12 Sep 2019.Search in Google Scholar

28. 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

29. Beastall GH. Harmonisation of specialist training and continuing professional development in laboratory medicine: a long but necessary journey. Clin Chem Lab Med 2015;53:1–3.10.1515/cclm-2014-1005Search in Google Scholar PubMed

30. Salinas M, López-Garrigós M, Gutiérrez M, Lugo J, Sirvent JV, Uris J. Achieving continuous improvement in laboratory organization through performance measurements: a seven-year experience. Clin Chem Lab Med 2010;48:57–61.10.1515/CCLM.2010.003Search in Google Scholar PubMed

31. Jones C, Gannon B, Wakai A, O’Sullivan R. A systematic review of the cost of data collection for performance monitoring in hospitals. Syst Rev 2015;4:38.10.1186/s13643-015-0013-7Search in Google Scholar PubMed PubMed Central

32. International Organization for Standardization. ISO 9001:2015(en) Quality management systems – Requirements.Search in Google Scholar

33. Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med 2013;51:187–95.10.1515/cclm-2012-0582Search in Google Scholar PubMed

Received: 2019-10-03

Accepted: 2020-01-29

Published Online: 2020-02-24

Published in Print: 2020-07-28

You are currently not able to access this content.

Articles in the same Issue

https://doi.org/10.1515/cclm-2019-1018

Keywords for this article

accreditation; computer model; ISO 15189; laboratory competence; medical education; quality assessment; quality indicators