Significance of Simultaneous Use of Different Methods for Interpretation of Internal Quality Control Data

An Experience of a Tertiary Care Hospital

Authors

  • Shakti Kumar Yadav North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Rupinder Kalra North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Aarzoo Jahan North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Sonam Kumar Pruthi North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Namrata Sarin North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Sompal Singh North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India
  • Harsh Vardhan Singh North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

DOI:

https://doi.org/10.21276/apalm.2715

Keywords:

quality control, LJ Chart, CUSUM, Westgard rules

Abstract

Background: Quality control is an essential part of quality management in medical laboratory. Various methods are available for the analysis of laboratory quality control data, common ones are Levey Jennings chart and Westgard rules. Westgard multi-rules are a set of rules based on combination of criteria to decide whether an analytical run is acceptable or unacceptable. CUSUM uses the cumulative sum of deviations from a target, however, it is rarely used in current medical laboratory practice. We share our experience of using Westgard rules and CUSUM in the analysis of laboratory quality control data.

Material and methods: Internal quality control values of 2-year period was included in the present study. Data for platelet count values of normal level control material run on a fully automated haematology analyser (Sysmex XT-2000i) were analysed. A total of 1825 data points were obtained. The data was interpreted by Westgard rules as well as cumulative sum method. The out of control events was analysed.

Results: There was 9 incidence of control value outside 3SD (Westgard Rule 13s) which was picked on Levey Jennings chart but missed by CUSUM method. There were 22 instances of shift in mean (bias) which were only picked by CUSUM method.

Conclusion: CUSUM was more sensitive for detection of bias whereas random error was picked-up early by Westgard rules. In conclusion we recommend the use of more than one method for analysis of quality control data.

Author Biographies

Shakti Kumar Yadav, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Rupinder Kalra, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Aarzoo Jahan, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Sonam Kumar Pruthi, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Namrata Sarin, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Sompal Singh, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Pathology

Harsh Vardhan Singh, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi India

Department of Biochemistry

References

1. Selvakumar R. Good laboratory practices. Springer; 2010.
2. Guidelines for good clinical laboratory practices (GCLP). New Delhi: Indian Council of Medical Research; 2008.
3. Momeni-Boroujeni A, Pincus MR. Systematic Error Detection in Laboratory Medicine. Quality Control in Laboratory. 2018:49.
4. Momeni A, Pincus M, Libien J. Introduction to statistical methods in pathology: Springer; 2018.
5. Karkalousos P, Evangelopoulos A. The history of statistical quality control in clinical chemistry and haematology (1950–2010). Int J Bio Lab Sci. 2015;4:1-11.
6. Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol. 1950;20:1059-66.
7. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. 1981;27:493-501.
8. Chang WR, McLean IP. CUSUM: a tool for early feedback about performance? BMC medical research methodology. 2006;6:8.
9. Page E. Cumulative Sum Control Charts. Technometrics 1961;3:1-9.
10. Westgard J, Groth T, Aronsson T, De Verdier C. Combined Shewhart-cusum control chart for improved quality control in clinical chemistry. Clinical Chemistry. 1977;23:1881-7.
11. Fortea-Sanchis C, Escrig-Sos J. Quality Control Techniques in Surgery: Application of Cumulative Sum (CUSUM) Charts. Cirugía Española (English Edition). 2019;97:65-70.
12. Gould AL. Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials. Stat Med. 2016;35:5561-78.
13. Righi L, Amarsy R, Picat MQ, Thuillier M, Cambau E, Raskine L, et al. Monitoring antimicrobial resistance (AMR) using CUSUM control charts. European Journal of Clinical Microbiology & Infectious Diseases. 2017;36:1519-25.
14. Rasmussen TB, Ulrichsen SP, Nørgaard M. Use of risk-adjusted CUSUM charts to monitor 30-day mortality in Danish hospitals. Clin Epidemiol. 2018;10:445-56.
15. Sampson ML, Gounden V, van Deventer HE, Remaley AT. CUSUM-Logistic Regression analysis for the rapid detection of errors in clinical laboratory test results. Clin Biochem. 2016;49:201-7.
16. Nightingale MJ, Madden S, Curnow E, Collett D, Procter S, Rowe GP. An evaluation of statistical process control techniques applied to blood component quality monitoring with particular reference to CUSUM. Transfus Med. 2012;22:285-93.
17. Woodall WH, Faltin FW. Rethinking control chart design and evaluation. Quality Engineering. 2019;31:596-605.

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Published

02-06-2020

How to Cite

1.
Yadav SK, Kalra R, Jahan A, Pruthi SK, Sarin N, Singh S, et al. Significance of Simultaneous Use of Different Methods for Interpretation of Internal Quality Control Data: An Experience of a Tertiary Care Hospital. Ann of Pathol and Lab Med [Internet]. 2020 Jun. 2 [cited 2024 Dec. 22];7(5):A216-220. Available from: https://pacificejournals.com/journal/index.php/apalm/article/view/2715

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