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This book takes the basic tenets of quality principles and practices and applies them to total quality management in the clinical laboratory. This management system can be implemented in many different types of laboratories. By using the quality prinicples of Deming and Juran, author Doug Hutchinson presents a detailed and practical approach to deploying TQM in these laboratory environments.
Written for suppliers, workers, and customers of clinical labs, TQM is addressed from viewpoints ranging from senior management to suppliers. Total Quality Management in the Clinical Laboratory begins with the history and philosophy of TQM. The book further investigates sources of Laboratory error, explains the TQM tools which are used to investigate system error, and completely deciphers the process design improvements to enhance reliability. Statistics related to these operations are evaluated. Detailed and practical approaches to deploying TQM in the lab setting are fully explored. TQM aspects of the Clinical Laboratory Improvement Act (CLIA) of 1988, such as process validation, are reviewed, as are international standards. The book also includes the Malcolm Baldrige National Quality Award criteria used in a hospital lab environment. The appendices offer a protocol for writing laboratory procedures using the CLIA Quality Assurance Program as a guideline.
