Clinical Laboratory Quality Management Technical Basis

Author: Feng Renfeng
Publisher:
Publish Date: 2003-07-01
Features: This book provides a detailed explanation of reagents, instruments, calibrators, and methods used in clinical laboratory testing, as well as their analytical performance. It covers aspects such as precision, accuracy, patient result reporting range, analytical sensitivity, analytical specificity, and reference range. Each performance is discussed from definition to experimental design, with statistical analysis of experimental results to illustrate the significance and practicality of each performance. Additionally, it evaluates the acceptability of the assessed performance and overall analytical performance of these testing products in conjunction with clinical requirements.
The book also thoroughly explains the importance of quality control in routine testing, the foundational principles and conditions required for laboratory quality control, how to draw control charts, how to understand control values in detection and loss of detection, and how to handle loss of detection situations. It introduces the characteristics, specific practices, and practical applications of several common control techniques.
The book compiles new content on analytical performance assessment and quality control techniques from major international standard documents, combined with the author's practical experience, and organizes it into relevant chapters, reflecting the current requirements for clinical laboratory quality management. All the content presented in the book includes specific examples to ensure practical applicability, allowing readers to imitate, learn, and use these quality management techniques. Through practice, readers can master these fundamental quality management skills.
This content is essential for laboratory personnel and clinical laboratory staff to ensure the reliability of test results.