Developing Patient Centric Quality Control Material

This educational guide outlines the development of patient-centric quality control (QC) material in clinical laboratories. It explains the significance of laboratory quality control, categorizing it into internal quality control (IQC) and external quality assessment (EQA). The guide emphasizes the importance of using high-quality QC materials to ensure accurate and reliable laboratory results, which are crucial for patient safety. It discusses the recent updates to ISO15189:2022 accreditation standards, highlighting the necessity of risk assessment in QC processes. The document details the challenges faced in creating QC materials that mimic patient samples, stressing the need for materials that are as close to 100% human as possible. The guide also examines the implications of using first-party versus third-party QC materials, advocating for the latter to ensure impartiality and reliability. Furthermore, it addresses the importance of maintaining clinically relevant concentrations in QC materials to align with clinical decision limits, ensuring that laboratory tests meet the required standards for patient care.