Quality Control Methods in the Clinical Laboratory
Module 1: Systems Thinking
As a laboratory professional, you are trained to see processes and systems and work with them. Often, these are immensely complex biological, chemical, or physical systems. This module introduces you to the concept of what systems thinking is and how you can use systems thinking to approach problems and challenges in new ways. You will be asked to think about how systems thinking applies to your own work setting.
Module 2: Process Improvement in the Laboratory
A quality management system should support continuous process improvement of laboratory practices. Process improvement is about discovering and applying best practices—and then continuously tweaking them to make them better. Process improvement is a habit that every laboratory should have. This module will introduce you to some key methods, concepts, and different process improvement methodologies that are used in the laboratory, including innovative laboratory Quality Improvement (QI) tools.
Module 3: Basic Concepts of Quality Control Methods
Development of a quality assurance and quality control policy requires understanding of the pre-analytical, analytical, and post-analytical phases so that potential failures in the entire process can be determined, resolved, and controlled. This module introduces you to a variety of quality assurance practices and explains how to apply these practices to the different diagnostic testing phases.
Module 4: Cost of Quality
The cost of quality represents “the difference between the actual cost of a product or service and what the reduced cost would be if there were no possibility of substandard service, product failure, or manufacturing defect.”1 This module introduces you to four types of quality costs, including the good and bad cost of quality. You will also be presented with a simple worksheet to help you calculate failure costs for a defined laboratory process.
1 Wood DC, ed. Principles of Quality Costs: Financial Measures for Strategic Implementation of Quality Management. 4th ed. Milwaukee, WI: ASQ Quality Press; 2013.
Module 5: Sample Management
The quality of the work a laboratory produces is only as good as the quality of the samples it uses for testing. This module introduces you to key components of an effective sample management system. You will also be given information to help you develop a system for managing samples from the time of collection to the final storage or disposal, in a manner that will ensure sample integrity.
Modules 6 and 7: Diagnostics in the Clinical Laboratory – Part 1
This module will define the role of the Food and Drug Administration (FDA) in diagnostic technology approval and utilization. We also explore new emerging diagnostic technologies and describe their application, along with how new diagnostic assays can be implemented effectively in your laboratory. This module will explain how to verify a new diagnostic assay in a new setting and highlight considerations and implications for implementing point-of-care diagnostics.
Module 8: Occurrence Management
A landmark report from the Institute of Medicine in 1999, “To Err is Human”, indicated that 44,000-98,000 people die each year as a result of preventable medical errors. This module focuses on patient safety and preventing, detecting, and acting on errors in the clinical laboratory.
Module 9: Customer Service in the Laboratory
Enhancing the experience of patients and their loved ones is crucial in today’s healthcare environment. This module will discuss the rationale and process for developing a program and monitoring and improving customer service. This module will describe basic elements that are essential for developing an effective customer service program.
Module 10: Innovations in the Laboratory
Everyday new innovations and technical advancements are occurring in the clinical laboratory to further enhance patient safety and public health. This module highlights innovations occurring in the laboratory, explains how you can drive innovation in your laboratory, identifies key drivers for implementing new innovations in a variety of settings, and will also provide you with some tools to help foster innovative thinking.