Research Article
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Test Specific Quality Control Plan: Maximum Run Size

Year 2025, Volume: 16 Issue: 4, 522 - 526, 01.10.2025
https://doi.org/10.31067/acusaglik.1623573

Abstract

ABSTRACT
Purpose : Internal quality control (QC) is an essential component of ensuring reliability in laboratory operations, with risk planning becoming increasingly critical in recent times. While each test varies in terms of demand and workload, the frequency of internal QC must be carefully determined. Adopting a test specific QC plan, rather than a generalized approach, allows for early detection of potential issues unique to each test, enabling timely corrective actions. According to the CLSI EP23 guideline, every laboratory should establish a tailored QC plan for each test to enhance accuracy, mitigate risks, and improve overall quality management.
Methods : In our study, we aim to determine the maximum analytical CV values achievable by calculating Max E(Nuf) (the expected number of unreliable final results before the last accepted quality control) and maximum run size data. These calculations will be based on Rilibäk TEa (Total Allowable Error) targets and laboratory workflow frequency for Glucose and Sodium (Na) tests, using the QC Constellation program in accordance with the CLSI EP23 guideline.
Results : Analytical CV values determined before the max E(Nuf) value exceeded 1 were 2.13 and 0.58 for glucose and Na, respectively. When the CV value for glucose increased to 2.83 and 0.78 for Na, the RMI value exceeded 1, indicating that the QC scheme was no longer at a controllable level.
Conclusion : Each laboratory should develop a test specific quality control (QC) plan tailored to its unique workload and operational volume.

Ethical Statement

This study was approved by the Ethical Committee for Istanbul Health Sciences University Umraniye Training and Research Hospital, with the assigned decision no: 525 and date: 16.01.2025.

Project Number

525

References

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There are 10 citations in total.

Details

Primary Language English
Subjects Analytical Biochemistry
Journal Section Research Articles
Authors

Çoskun Çavuşoğlu 0000-0001-9238-3878

Project Number 525
Early Pub Date September 9, 2025
Publication Date October 1, 2025
Submission Date January 22, 2025
Acceptance Date June 21, 2025
Published in Issue Year 2025 Volume: 16 Issue: 4

Cite

EndNote Çavuşoğlu Ç (October 1, 2025) Test Specific Quality Control Plan: Maximum Run Size. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi 16 4 522–526.