QMS: A Model for Laboratory Services GP26-A4

Abstract

The fourth edition of Quality Management System: A Model for Laboratory Services (GP26-A4) goes beyond laboratory quality assurance and control to focus on a broader systems approach to manage quality. The revised guideline, developed by the Clinical and Laboratory Standards Institute (CLSI), provides a framework for managing the laboratory’s path of workflow in an integrated model based on 12 quality system essentials (QSEs). “This important advancement is designed to ensure that the laboratory’s quality management system (QMS) drives the highest quality of patient care,” explained Jennifer Rhamy, MBA, MA, MT(ASCP),SBB, HP Executive Director, Laboratory Accreditation Program, The Joint Commission, and a participant of the working group that revised the guideline. The revised guideline reflects the maturation and growth of QMS concepts and knowledge within the clinical laboratory field. It describes best practices in laboratory management, as determined through a rigorous consensus process involving a wide range of subject matter experts. The QSEs were reorganized in this edition to more logically support the components of the QMS and to highlight the importance of leadership responsibilities for laboratory quality, reduction of medical errors, and more effective and efficient laboratory operations. “Labs must have committed leadership to have a thriving and successful QMS,” said Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), Regulatory and Accreditation Manager, Mayo Clinic, and vice-chairholder, (Standing) Subcommittee on Quality …