Risk, Quality and Process Based Management Model in Medical Laboratories

Medical (clinical) laboratory management has a key position in the healthcare sector in terms of human health, patient safety, quality of community/population life and cost effective healthcare expenditures. Medical/Clinical laboratories (MLs/CLs) are also the data centers of healthcare institutions. Laboratory tests are requested from approximately 80% of individuals admitted to a health institution, and 70-80% of medical decisions are made based on the test results. In addition to providing reliable test results to each individual/patient in a timely and cost-effective manner, information about public health status can also be obtained from laboratory data.
Their success in these responsibilities and duties is directly proportional to their ability to
establish a well-structured risk, quality and process-based system.
In this book: a risk, quality and process-based management model is presented. The book covers the steps of recognizing and introducing the process framework of a medical (clinical) laboratory that is composed of the management and support processes. The total examination process, which is the main core process of an ML/CL, is composed of 5 subprocesses. The steps also include the application of risk and quality management to every process. By following this book, the laboratory professional will be able to define and introduce all the processes of a ML/CL and establish the management system with the process approach. Laboratory professionals will be able to familiarize themselves with each process and create process-oriented risk and quality management systems following the recommended steps. A continuous process improvement system, based on the Plan-Do-Check-Act (PDCA) Cycle, will also be established. Hence, the ML/CL will be prepared to meet all the requirements of external assessment programs, including the ISO 9001:2015 Quality Management System Standard, the excellence models such as the EFQM, and the Accreditation Standard ISO 15189:2022 for Medical Laboratories-Requirements for Quality and Competence.". The book is designed to be used as a handbook and consists of 22 chapters. The reader will be able to define the process framework of a medical laboratory and identify its documents according to the document hierarchy. Additionally, they can structure the total testing process, which includes preanalytical, analytical, and postanalytical processes both inside and outside the laboratory. Furthermore, the book covers topics on management and support processes as well as data analysis, the development of training programs for laboratory professionals and providing the useful information to the patients. Moreover, the book reviews the governance system, the
alignment of process objectives with strategic goals, outcomes of performed projects related to the medical laboratory management, and the essential competencies for a medical laboratory manager.
This book should be read with the book “Process-Based Management Are You Ready for Digital Transformation? (For Public, Private and Non-Governmental Organizations) by Diler Aslan”