Quality Assurance: Are Laboratories Assuring, Assessing, or Assuming the Quality of Clinical Testing Today?

Abstract: Quality assurance implies making certain, guaranteeing the attainment of quality. Do laboratories actually guarantee the quality of testing services today? If not, what is the purpose of quality assurance plans, programs, and practices? Have laboratories even defined the quality to be achieved for each test? If not, how can quality be guaranteed? Do current efforts in assessing quality provide for real-time control that will guarantee quality? If not, are laboratories just assuming that measuring quality will somehow make it happen? Even analytical quality, which is fundamental for the core production processes of any laboratory, is mainly assessed and assumed, not assured. Problems include the lack of well defined quality requirements, inadequate method performance, poorly designed statistical control procedures, misguided quality control instructions and recommendations, insufficient technical quality management skills, reduced operator skills, and delays in implementing of laboratory regulations. Quality assurance should be understood, not as a component, but as the outcome of a quality management process that includes quality planning, quality laboratory practices, quality control, quality assessment, and quality improvement, all linked together and guided by quality goals and customer requirements, and applied to the total testing process. In the future, automation and computerization will be necessary to manage the quality of centralized and distributed laboratory testing. Analytical quality will be guaranteed through on-line or on-board quality control. Other critical quality characteristics will need real-time monitors and control mechanisms to guarantee quality if process failures cannot be prevented.