Clinical Laboratory Quality Management Technical Basis

Author: Feng Renfeng
Publisher:
Publish Date: 2003-07-01
Features: This book covers reagents, instruments, calibrators, and methods used in clinical laboratory testing, as well as their analytical performance. It discusses each performance—precision, accuracy, patient result reporting range, analytical sensitivity, analytical specificity, and reference range—starting from definitions to experimental design, followed by statistical analysis of experimental results to explain the significance and practicality of each performance. It also evaluates the acceptability of the assessed performance and overall analytical performance in relation to clinical requirements. The book provides detailed explanations on the importance of quality control in routine testing, the foundational knowledge and conditions required for laboratory quality control, how to draw control charts, how to understand control values in the probe and loss of probe, and how to handle loss of probe situations. It also introduces the characteristics, specific practices, and practical applications of several common control techniques. The book compiles new content on analytical performance evaluation and quality control techniques from major international standard documents, combined with the author's practical experience, into relevant chapters, reflecting the current requirements for clinical laboratory quality management. All the content in the book is accompanied by specific examples to ensure operability, allowing readers to learn by imitation and apply these quality management techniques in practice. These are essential for laboratory personnel and clinical laboratory staff to ensure reliable test results.