1995 Institute: Frontiers in Laboratory Practice Research

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. Introduction Quality Assurance (QA) has many requirements to establish the necessary definitions, but the expectation of customers process specifications? If not, how can and consumers of health care services is that quality be guaranteed? quality should be certain. This implies Guaranteeing quality requires guaranteeing the attainment of quality. QA measurements to assess process performance sounds right, but are laboratories actually and to control process output. Do initial doing it right? Do current laboratory QA method validation studies and periodic practices guarantee quality? verification checks assure that daily quality is Guaranteeing quality presumes that satisfactory? Is the four month cycle of laboratories know the quality that needs to proficiency testing adequate for assuring be achieved. Have laboratories even daily quality? Does periodic monitoring of defined quality requirements for critical quality indicators and outcome measures characteristics such as analytical quality? Do assure that daily quality is satisfactory? Are laboratories know how to use quality 18