Innovative Approaches in Quality Management in Clinical Laboratories

Abstract

Clinical laboratories must adhere to Good Laboratory Practices (GLP) to ensure the quality, integrity, and reliability of patient results. GLP principles include organization and personnel, a quality assurance program, facilities, equipments, reagents and materials, test systems, standard operating procedures, result reporting, and archiving of records and reports (Wikipedia,2010). This chapter presents a review of the latest requirements in quality control and quality management in certified clinical laboratories. We will describe different stages in clinical testing procedures and highlight the critical steps that need to be monitored using quality assurance indicator tools. In addition, we will present our latest contribution to the field of quality control computer software which encompasses an innovative approach in monitoring quality control and quality assurance in laboratories. Accumulating and analyzing quality control data as well as quality indicators help in developing the performance improvement plan in the laboratory. Performance improvement is a process which uses information from multiple sources to increase the probability of accomplishing desired outcomes to better serve the needs and expectations of patients. The most frequently used performance improvement tools are: 1. FOCUS-PDCA – framework for improvement, 2. Failure Modes and Effects Analysis (FMEA), 3. Root Cause Analysis (RCA) and 4. Control Charts. However, in this chapter we will focus on one model of quality improvement approaches which is FOCUS-PDCA and control charts and give examples on its implementation in a clinical laboratory setting.