Abstract:This presentation will cover the principles of ISO 15189, which applies to accreditation of medical reference laboratories. It will also emphasize the key concepts of ISO 15189: developing a quality management system, designing continual improvement projects, and utilizing root cause analysis to assess problems. The differences between ISO 9001 and ISO 15189 will be discussed to emphasize the specificity of ISO 15189 to medical laboratories. The cyclical process of earning and maintaining accreditation will also be presented in detail.
Speaker Bio: Shaun Waters developed a year-long continuous improvement project as part of Genzyme Genetics’ College of American Pathologists (CAP) ISO 15189 accreditation process. The project was designed to determine the root cause of a recurring issue involving a pervasive contamination problem with specimens that were received from certain clients. Shaun presented the findings of his project to the CAP auditors during the final evaluation. Genzyme Genetics became the 2nd lab in the U.S. to achieve the ISO 15189 accreditation.
Shaun graduated from UC Riverside in 1999 with a Bachelor of Science in Biochemistry. He began his laboratory career at Genetics Center in Orange, CA, where he worked primarily performing tissue culture for cytogenetics applications for 9 years. Shaun has been a CLSp(CG) licensed cytogenetics technologist for 15 years. He also earned his MBA from USC Marshall School of Business, while working full-time in the laboratory and attending the MBA.PM program in the evenings, specifically designed for working professionals.
Shaun continued his cytogenetics career with Genzyme Genetics working as part of the team to earn ISO 15189 accreditation. He is currently working as a product manager for the Cytogenetics and Classical Media lines for Irvine Scientific, a tissue culture media company, in Santa Ana, CA.