Reliability and Quality Control of Automated Diagnostic Analyzers

  • Ilias Stefanou
  • Alex Karagrigoriou
  • Ilia VontaEmail author
Part of the Management and Industrial Engineering book series (MINEN)


The purpose of this work is to show how statistical quality control methods contribute to the quality control of diagnostic tests in clinical laboratories. This chapter presents the difficulties as well as the advantages of the implementation of quality control techniques in the daily routine of laboratories together with the disadvantages of non-application. It emphasizes the role of good and uninterrupted operation of laboratory equipment to ensure quality and how to reduce the effects of time and its use with a comprehensive maintenance program. It also documents the role of statistical quality control in early detection of a malfunction of the equipment and thereby in avoiding an incorrect result from the reference laboratory. Finally, it proposes ways to improve the reliability and maintainability of the equipment and highlights the contribution of statistical quality control to clinical laboratory equipment.


Automated diagnostic analyzers Availability Clinical laboratory Maintainability Reliability Statistical quality control 


  1. 1.
    Archibald RM (1950) Criteria of analytical methods for clinical chemistry, Anal Chem, 22(5), 639-642Google Scholar
  2. 2.
    Bakouros I (2002) Reliability and Maintenance(in Greek), Patras, Greece: Hellenic Open UniversityGoogle Scholar
  3. 3.
    Carroll AT, Pinnick AH, Carroll EW (2003) Brief Communication: Probability and the Westgard Rules, Ann Clin and Lab Sc, 33(1), 113-114Google Scholar
  4. 4.
    Cembrowski G, Luvetzsky E, Patrick C, Wilson M (1988) An optimized quality control procedure for haematology analyzers with the use of retained patient specimens, Am J Clin Pathol, 89(2), 203-210Google Scholar
  5. 5.
    Cooper G (2008) Basic Lessons in Laboratory Quality Control, Bio-Rad Laboratories, IncGoogle Scholar
  6. 6.
    Freier EF, Rausch VL (1958) Quality control in clinical chemistry, Am J Med Tech, 24, 195-200Google Scholar
  7. 7.
    Henry RJ (1959) Use of the control chart in clinical chemistry, Clin Chem, 5(4), 309-319Google Scholar
  8. 8.
    Henry RJ, Segalove M (1952) The running of standards in clinical chemistry and the use of control chart, J. Clin Pathol, 5(4), 305-311Google Scholar
  9. 9.
    Hoffmann R, Waid M (1965) The “average of normals” method of quality control, Am J Clin Pathol, 43, 134-141Google Scholar
  10. 10.
    Karkalousos P, Evangelopoulos A (2011) Quality Control in Clinical Laboratories, Applications and Experiences of Quality Control, O. Ivanov (Ed.), ISBN: 978-953-307-236-4, Intech, ZagrebGoogle Scholar
  11. 11.
    Karkalousos P, Evangelopoulos A (2015) The History of Statistical Quality Control in Clinical Chemistry and Haematology (1950 – 2010), Intern J. Biomed Lab Sc, 4, 1-11Google Scholar
  12. 12.
    Levey S, Jennings ER (1950) The use of control charts in the clinical laboratory, Am J Clin Pathol, 20(11), 1059-1066Google Scholar
  13. 13.
    Mobley KR. (2004) Maintenance Fundamentals, 2nd ed., ElsevierGoogle Scholar
  14. 14.
    Nosanchuk JS,  Gottmann AW (1974) CUMS and delta checks, Am J Clin Path 62, 707-712. Google Scholar
  15. 15.
    O’Connor PDT, Kleyner, A (2012) Practical Reliability Engineering, 5th ed.,WileyGoogle Scholar
  16. 16.
    Rausand Μ, Hoyland, A (2004) System Reliability Theory: Models, Statistical Methods, and Applications, 2nd ed. WileyGoogle Scholar
  17. 17.
    Renyan J (2015) Introduction to Quality and Reliability Engineering, Beijing: Springer, Science PressGoogle Scholar
  18. 18.
    Rikos N (2015) The concept of quality in health services (in Greek), Τo Vima tou Asklipiou, 14(4), 247-252Google Scholar
  19. 19.
    Rocco RΜ (2005) Landmark Papers in Clinical Chemistry, ElsevierGoogle Scholar
  20. 20.
    Shewhart WA (1931) Economic Control of Quality of Manufactured Product, D. Van Nostrand, Princeton, Eight PrintingGoogle Scholar
  21. 21.
    Shibata R (1976) Selection of the order of an autoregressive model by Akaike’s information criterion, Biometrika, 63, 117–126Google Scholar
  22. 22.
    Verma AK, Ajit S, Karanki DR (2016) Reliability and Safety Engineering, 2th ed. Hoang Pham, Piscataway, USA: SpringerGoogle Scholar
  23. 23.
    W.H.O. (2011a) Laboratory quality management system: handbook, World Health OrganizationGoogle Scholar
  24. 24.
    W.H.O. (2011b) Medical equipment maintenance programme overview, World Health OrganizationGoogle Scholar
  25. 25.
    Westgard JO (2011) QC Past, Present and Future, Basic QC Practices,
  26. 26.
    Westgard JO, Barry PL, Hunt MR, Groth T. (1981) A multi-rule Shewhart chart for quality control in clinical chemistry, Clin Chem 27, 493-501Google Scholar
  27. 27.
    Westgard JO, Groth T, Aronsson, T, Falk H, de Verdier CH (1977) Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection, Clin Chem, 23(10), 1857-1867Google Scholar
  28. 28.
    Westgard JO, Smith FA, Mountain PJ, Boss S (1996) Design and assessment of average of normals (AON) patient data algorithms to maximize run lengths for automatic process control, Clin Chem, 42, 1683-1688Google Scholar
  29. 29.
    Witte D, Rodgers J, Barrett D (1976) The anion gap: its use in quality control, Clin Chem, 22, 643-646Google Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Ilias Stefanou
    • 1
  • Alex Karagrigoriou
    • 2
  • Ilia Vonta
    • 3
    Email author
  1. 1.Hellenic Open UniversityPatrasGreece
  2. 2.University of the AegeanSamosGreece
  3. 3.National Technical University of AthensAthensGreece

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