Utilization of Repeat Patient Sample as an Internal Quality Control Measure: The Pilot Study Results
Abstract
Introduction: To provide reliable result for every sample, internal and external quality control (QC) measures) must be in place in a clinical laboratory. The present study was designed to asses and re-establishes the utility and efficacy of random patient samples as a regular QC practice.
Method: For quality control (QC) of hematology section a random repeated patient’s sample technique was practiced, the difference between present day sample result and that on immediate previous day was calculated. The differences for Hemoglobin, Red Blood Cells Total Leukocyte count and Platelet count were noted. The mean and standard deviation of difference were calculated, with and without considering the plus (+) and minus (-) sign. Levey–Jenning’s chart (LJ chart) and Cusum chart of the signed and unsigned differences were plotted for all these four hemogram parameters.
Results: In a total of 246 repeat sample differences, a higher number (49) of Westgard rules violations was observed in LJ. Chart of signed differences, whereas lower number (30) of violations of Westgard rules were observed on analysis of absolute differences. The difference in signed and absolute differences for RBC parameter was statistically significant (p=0.045). Similarly, 16 out-of-limit events were identified on analysis of Cusum chart of signed differences. Whereas only 12 out-of-limit events were identified on analysis of Cusum chart of absolute differences.
Conclusion: Present study show that a QC strategy of daily planned repeat sample testing can improve the out-of-control error detection ability simply by using signed difference of repeat sample result and applying usual Westgard rules.
How to cite this article:
Thakur SK, Sinha AK, Sharma SK, Jahan A, Gupta R, Singh S, Singh H. Utilization of Repeat Patient Sample as an Internal Quality Control Measure: The Pilot Study Results. Rec Adv Path Lab Med. 2020;6(3&4):17-22.
DOI: https://doi.org/10.24321/2454.8642.202007
References
Greer JP, Arber DA, Paraskevas F. Examination of
the Blood and Bone Marrow. In: Greer JP, Arber DA.
Editors Wintrobe’s Clinical Hematology Philadelphia:
;1-45.
Brittin GM, Brecher G, Johnson CA, Elashoff RM.
Stability of blood on commonly used anticoagulants.
Am J Clin Pathol 1969;52:690-694.
Cembrowski GS, Lunetzky ES, Patrick CC and Wilson MK.
An optimized quality control procedure for hematology
analyzers with the use of retained patient specimens.
Am J Clin Patho 1988 Feb;89(2):203-10
Buttarello M. Quality specification in haematology:
the automated blood cell count. Clin Chim Acta.
;346:45-54.
Hu X, Li Y, Xu L, Wu J, Huang Y, Song Y. Study on the
accuracy of automated hematology analyzers in
Shanghai. Southeast Asian J Trop Med Public Health
;33:1-5.
Levey S, Jennings ER. (November 1). “The use of
Control Charts in the Clinical Laboratory”. American
Journal of Clinical Pathology doi:10.1093/ajcp/20.11_
ts.1059. PMID 14783086 – via Oxford Academic
;20(11):1059–1066.
Westgard JO, Barry PL. “Cost-Effective Quality Control:
Managing the Quality and Productivity of Analytical
Processes”, AACC Press 1986.
Westgard, JO, Barry PL, Hunt MR. “A Multi-rule Shewhart
Chart for Quality Control in Clinical Chemistry”, Clinical
Chemistry, 1981;27:493–501.
Page ES. Cumulative Sum Control Charts. Techno
metrics, https://doi.org/10.1080/00401706.1961.10
1961;3:1-9.
Daudin JJ. Double sampling X_ charts. J Qual Technol
;24:78–87.
Briggs C, Longair I, Kumar P, Singh D and Machin SJ.
Performance evaluation of the Sysmex haematology
XN modular system. J Clin Pathol 2012;65:1024-30.
Curtis A. Parvin, Lakshmi Kuchipudi, and John C. Yundt-
Pacheco, Should I Repeat My 1:2s QC Rejection?,
Clinical Chemistry 2012;58:5:925-929.
Cembrowski GS, Smith B, Tung D. Rationale for using
insensitive quality control rules for today’s hematology
analyzers. Int J Lab Hematol 2010;32:606–15.
Saxena R, Kucheria K, Tyagi S and Sazawal S. Quality
Control. In Saxena R, Pati HP, editors. Laboratory
Techniques in Hematology New Delhi: Jaypee
;384-92.
Briggs CJ, Linssen J, Longair I and MachinSJ. Improved
flagging rates on the Sysmex XE- 5000 compared with
the XE-2100 reduce the number of manual film reviews
and increase laboratory productivity. Am J Clin Pathol
;136:309-16.
Hill VL, Simpson VZ, Higgins JM, Hu Z, Stevens RA,
Metcalf JA. Evaluation of the performance of the
SYSMEX XT-2000i Hematology Analyzer with the whole
bloods stored at room temperature. Lab Med 2009;
:709-18.
Fernandes B, Hamaguchi Y. Automated enumeration
of immature granulocytes. Am J Clin Pathol 2007;
:454-63.
Singh T. Automation in Cell Counts, Hemoglobin
Separation, Immunophenotyping and Coagulation.
In: Atlas and Text of Hematology. Avichal, 2014;53-61.
Dutra FR. Monitoring the quality of blood cell counts
with replicate determinations on routine samples.
Tech Bull Regist Med Technol PMID: 5911988
;36(7):182-4.
Riddick JH, Johnston CL. Hematology control using
computerized range charts. Laboratory Medicine
;3:32-34.
Carstairs KC, Peters E, Kuzin EJ. Development and
description of the “random duplicates” method of
quality control for a hematology laboratory. Am J Clin
Pathol 1977;67:379-385.
Orser B. Hematology quality control and the Coulter
S+II. Am J Med Technol 1983;49:643-647.
Weisbrot IM. Statistics for the clinical laboratory.
Philadelphia: JB Lippincott, 1985;85.
Yadav SK, Kalra R, Jahan A, Pruthi SK, Sarin N, Singh
S. Significance of Simultaneous Use of Different
Methods for Interpretation of Internal Quality Control
Data: An Experience of a Tertiary Care Hospital Annals
of Pathology and Laboratory Medicine, 2020;7(5):A-
-20
Bull BS, Elashoff RM, Heilbron DC, Couperus J. A study
of various estimators for the derivation of quality
control procedures from patient erythrocyte indices.
Am J Clin Pathol doi: 10.1093/ajcp/61.4.473. PMID:
1974;61(4):473-81.
Nosanchuk J, Gottmann A. Cums and Delta Check. Am
J Clin Pathol 1974;62:707-12.
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