Skip to main content
SpringerLink
Log in

Evaluation of the role of metrological traceability in health care: a comparison study by statistical approach

  • General Paper
  • Published:
Accreditation and Quality Assurance Aims and scope Submit manuscript

Abstract

To evaluate the role of metrology in healthcare facilities, a study was performed among Portuguese hospitals to identify and analyze issues concerning the concept of metrological traceability. The discussion is structured around a dataset obtained from a survey questionnaire covering 44 public and private Portuguese hospitals. The principal results of our analysis include identifying some key indicators that apply to certified/accredited hospitals. Test reports and calibration certificates were the main metrological traceability documents required by the hospitals. The acquisition of medical measuring instruments with conformity reports depended on the type of hospital. Maintenance was considered the most relevant issue for private hospitals, whereas for the public hospitals, this issue is less important than trust in the supplier. For public hospitals, purchase price was the most important requirement. For hospitals that acquire calibrated measuring instruments, only 50 % perform in-house calibration. We conclude that trust in supplier is associated with a lower overall budget for maintenance operations. The protocol established by hospitals to acquire measurement instruments does not reflect metrological concerns, and the relationship between maintenance and metrological operation is not well established. Thus, we conclude that metrological traceability is largely absent in the daily considerations of healthcare professionals and facilities.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. White R (2011) The meaning of measurement in metrology. Accred Qual Assur 16(1):31–41

    Article  Google Scholar 

  2. Kind D, Lubbig H (2003) Metrology—the present meaning of a history term. Metrology 40:255–257

    Article  Google Scholar 

  3. JCGM 200 (2012) International vocabulary of metrology. Basic and general concepts and associated terms. BIPM, Sevres. http://www.bipm.org/

  4. Hratch G, Semerjian R, Watters J (2000) Impact of measurement and standards infrastructure on the national economy and international trade. Measurement 27:179–196

    Article  Google Scholar 

  5. Golze M (2003) Why do we need traceability and uncertainty evaluation of measurement and test results? Accred Qual Assur 8:539–540

    Article  Google Scholar 

  6. Desimoni E, Brunetti B (2006) Considering uncertainty of measurement when assessing compliance or non-compliance with reference values given in compositional specifications and statutory limits: a proposal. Accred Qual Assur 11(7):363–366

    Article  CAS  Google Scholar 

  7. Ashford P (2010) Traceability. Cell Tissue Bank 11:329–333. doi:10.1007/s10561-010-9195-3

    Article  Google Scholar 

  8. Vesper HW, Thienpont LM (2009) Traceability in laboratory medicine. Clin Chem 55(6):1067–1075

    Article  CAS  Google Scholar 

  9. Armbruster D, Richard R (2007) The joint committee for traceability in laboratory medicine (JCTLM): a global approach to promote the standardization of clinical laboratory test results. Clin Biochem Rev 28(3):105–114

    Google Scholar 

  10. http://www.bipm.org/en/committees/jc/jctlm/

  11. http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

  12. Ferreira MC (2011) The role of metrology in the field of medical devices. Int J Metrolol Qual Eng 2:135–140. doi:10.1051/ijmqe/2011101

    Article  Google Scholar 

  13. A’Court C, Stevens R, Sanders S et al (2011) Type and accuracy of sphygmomanometers in primary care: a cross-sectional observational study. Br J Gen Pract 61(590):598–603. doi:10.3399/bjgp11X593884

    Article  Google Scholar 

  14. O’Brien E, Neil A (2007) Validation and reliability of blood pressure monitors. Clínical hypertension and vascular diseases: blood pressure monitoring in cardiovascular medicine and therapeutics, pp 97–132. ISBN: 978-1-59259-978-3

  15. Turner M, Speechly C, Bignell N (2007) Sphygmomanometer calibration why, how and how often? Aust Fam Physician 36(10):834–838

    Google Scholar 

  16. Juntaro I (2008) Improving the realibility of temperature measurements taken with clinical infrared ear thermometers. Synthesiology I:47–58

    Google Scholar 

  17. Simpson R, Machin G, McEvoy H, Rusby H (2006) Traceability and calibration in temperature measurement: a clinical necessity. J Med Eng Technol 30(4):212–217. doi:10.1080/03091900600711530

    Article  CAS  Google Scholar 

  18. Chung W, Chen C (2010) Evaluation of performance and uncertainty of infrared tympanic thermometers. Sensors (Basel) 10(4):3073–3089. doi:10.3390/s100403073

    Article  Google Scholar 

  19. Sandhu S, Chattopadhyay S, Amariotakis G et al (2009) The accuracy of continued clinical use of Goldmann applanation tonometers with known calibration errors. Ophthalmology 116(1):9–13. doi:10.1016/j.ophtha.2008.07.014

    Article  Google Scholar 

  20. Ogbuehi K, Almubrad T (2008) Accuracy and reliability of the Keeler Pulsair EasyEye non-contact tonometer. Optom Vis Sci 85(1):61–66

    Article  Google Scholar 

  21. Choudhari S, George R, Baskaran M et al (2009) Measurement of Goldmann applanation tonometer calibration error. Ophthalmology 116(1):3–8

    Article  Google Scholar 

  22. Jensen R, Teeter J, England R, White H, Pickering E (2007) Instrument accuracy and reproducibility in measurements of pulmonary function. Chest 132:388–395. doi:10.1378/chest.06-1998

    Article  Google Scholar 

  23. Miller R, Hankinson J, Brusasco J et al (2005) Standardisation of spirometry. Eur Respir J 26:319–323

    Article  CAS  Google Scholar 

  24. Abbas T, Charles T (2002) Handbook of mixed methods in social & behavioral research. Authors editors. ISBN-13: 978-0761920731

  25. William T, James PD (2006) The research methods knowledge base (3rd edn). ISBN-13: 978-1592602919

  26. Brannen J (2005) Mixing methods: the entry of qualitative and quantitative approaches into the research process. Int J Soc Res Methodol 8(3):173–184. doi:10.1080/13645570500154642

    Article  Google Scholar 

  27. Maroco J (2007) Statistical analysis using SPSS (3rd ed). Walker editions. ISBN: 978-972-618-452-2

  28. Morris J, Gardner M (1988) Calculating confidence intervals for relative risks (odds ratios) and standardised ratios and rates. Br Med J 296:1313–1316

    Article  CAS  Google Scholar 

  29. Szumilas M (2010) Explaining odds ratios. Can Acad Child Adolesc Psychiatry 19(3):227–229

    Article  Google Scholar 

  30. DGS (2008) Elementos Estatísticos: Informação Geral. Direcção de Serviços de Epidemiologia e Estatísticas de Saúde. Divisão de Estatísticas de Saúde. Lisboa. ISSN 0872-1114

  31. ISO 13485 (2003) Medical devices-quality management systems—requirements for regulatory purposes. International Organization for Standardization, Geneva

    Google Scholar 

  32. Ghiglione R, Matalon B (1997) O Inquérito: Teoria e Prática, 3ª edn. Celta Editora, Oeiras

    Google Scholar 

  33. ISO 15189 (2012) Medical laboratories—Requirements for quality and competence. International Organization for Standardization, Geneva

  34. ISO 14001 (2004) Environmental management systems. International Organization for Standardization, Geneva

    Google Scholar 

  35. ISO 22000 (2005) Food safety management. International Organization for Standardization, Geneva

    Google Scholar 

  36. ISO 9001 (2008) Quality management systems-requirements. International Organization for Standardization, Geneva

Download references

Acknowledgments

The authors wish to thank Dr. Adriaan van der Veen, VSL, Delft, the Netherlands, for helpful advice.

Author information

Authors and Affiliations

  1. Portuguese Institute for Quality, Rua António Gião, 2, 2829-513, Caparica, Portugal

    Maria do Ceu Ferreira

  2. Faculty of Sciences and Technology, UNIDEMI, 2829-516, Caparica, Portugal

    Maria do Ceu Ferreira, Ana Matos & Rogério Puga Leal

Authors
  1. Maria do Ceu Ferreira
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ana Matos
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rogério Puga Leal
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Maria do Ceu Ferreira.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

do Ceu Ferreira, M., Matos, A. & Leal, R.P. Evaluation of the role of metrological traceability in health care: a comparison study by statistical approach. Accred Qual Assur 20, 457–464 (2015). https://doi.org/10.1007/s00769-015-1149-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00769-015-1149-9

Keywords

Search

Navigation