The Fundamentals for Implementing a Quality Management System in the Clinical Laboratory

Indicators show that quality is high on health care organizations’ priority lists for 2007 and beyond. Strategies to operate with well-defined, documented policies, processes, and procedures have risen to the top of the clinical-laboratory agenda. With recent emphasis on education and communication in the regulatory and accreditation process, laboratories are challenged to boost their efforts to meet requirements and provide the highest level of patient care. Since numerous challenges remain, many health care organizations are still trying to create the right quality-management-systems strategy, and are striving to get organizational commitment, communication, and alignment.

After years of experience with the quality-management systems approach, the Clinical and Laboratory Standards Institute (CLSI) released a proven model, The Key to Quality, designed to assist clinical laboratories with creating, implementing, and refining a quality-management system. A recent CLSI market-research evaluation survey included a prototype for review and comment by laboratory professionals. Results from the survey on its practical application show that laboratory professionals believe The Key to Quality would be useful and would ease many of the difficulties in guiding management and staff in implementing a quality-management system in the laboratory.

Read the full article as originally published in LABMEDICINE, June 2007. [ return to top ]