Test Specific Quality Control Plan: Maximum Run Size

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.