This book explains how SaaS works and lists and describes many common misconceptions and pitfalls that laboratories have about implementing Quality Management Systems (QMS). By walking the reader through all ISO 15189 Standards and describing each in detail, we can show how to implement them in common sense and meaningful ways. This book demonstrates to clinical laboratories how to combine the rigor of international standards with the inherent benefits of contemporary cloud-based software systems so that they can involve the entire laboratory in making quality a shared habit.
Readership: Biomedical researchers including professional researchers (basic scientists, clinician-scientists), research assistants, and laboratory technical staff; students and teachers in biomedical studies (undergraduate, masters, doctoral students); pharmaceutical and biotechnological industry personnel; health legislation executives and administrators.
Dr Masahiko Amano served as a research scientist at Mead-Toppan and was the technical supervisor for Next-Generation Sequence testing for Riken Genisis. Dr. Amano is the head engineer for the development of LEAP system content architecture and is involved in the implementation and maintenance of QMS in several large clinical and research laboratories.
Robert Bredt, B.S., M.D., is a practicing pathologist at the Department of State Health Services in Texas and the Medical Director of the Texas Medical Board. He is a licensed international inspector for the College of American Pathologists (CAP), and Clinical Laboratory Inspector for A2LA, accrediting clinical laboratories for the ISO 15189 Standard.
Mark Colby, B.S., is the CEO of CGI KK, a leading company specializing in clinical laboratory QMS solutions for the past 30 years. He is the developer of several software programs, including LEAP. He is also the author of Negotiating the Gray Maze, The Business of Healthcare in Japan, and The Japan Healthcare Debate: Diverse Perspectives. Mark is also the Editor-in-Chief of In-Vitro Diagnostics Global News, a leading clinical laboratory periodical.
Trent Freeman, B.S. M.S. M.T. (ASCP) has been running clinical laboratories for over 25 years as a regional laboratory manager at US Navy hospital laboratories in Europe, Asia, and the Middle East, where he was director of the Medical Laboratory Training Program. He is currently the head of laboratory services at the University Health System in San Antonio, Texas. He was Assistant Professor at Georgetown University covering Parasitology and Mycology and Hematology technical specialties and Trent is also an inspector of clinical laboratories for the College of American Pathologists.
