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.
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.
525
| Primary Language | English |
|---|---|
| Subjects | Analytical Biochemistry |
| Journal Section | Research Articles |
| Authors | |
| 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 |