Operational Quality Management in the Clinical Laboratory
Module 1: Introduction to Quality Management Systems
How do we achieve laboratory excellence? By implementing a laboratory quality management system (LQMS). Implementation of a LQMS will not guarantee an error-free laboratory, but it will detect errors and prevent them from reoccurring. This module will explain the basic requirements to create a LQMS and share the importance of implementing quality standards into your laboratory.
Module 2: Project Management in Laboratory Medicine
How can you apply project management skills to your current work in order to improve quality and productivity? This module will introduce you to project management skills and how they translate to the laboratory environment. You will learn the importance of having a strategic plan, the elements that are needed when creating one, and begin the process of creating a quality manual with your laboratory’s vision and mission statements.
Module 3: Organization and Personnel Management
Organizational and personnel management are foundations of a high functioning laboratory. In this module you will learn about organizational structure, management roles and responsibilities, and other factors needed for a successful laboratory quality management system. You will also learn about the personnel management principles that contribute to a workforce that is qualified, competent, and follows quality laboratory practices.
Module 4: Facilities and Safety Management
By their very nature, laboratory environments are full of hazards and as a lab manager, it is your duty to ensure clear safety guidelines are established and followed to promote a safe workplace environment. This module will discuss the lab manager’s role in facilities design and management, as well as general overview safety management, including biosafety.
Module 5: Equipment Management and Purchasing Inventory
Equipment management is an essential element of a quality management system. Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable, and timely testing. Efficient and cost-effective laboratory operations need the uninterrupted availability of reagents, supplies, and services. This module will cover the equipment management process, purchasing, and inventory management topics.
Module 6: Laboratory Compliance, Laws, and Regulations
Compliance and regulation are a critical component of a LQMS and contribute to patient safety. This module covers the laws and regulations that govern lab practice in the US (national-state-local) and internationally through the Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) and the International Organization for Standardization (ISO). This module will also discuss elements required to create a basic compliance plan.
Module 7: Managing Laboratory Records, Assessments and Audits
A cornerstone to a LQMS is documents and records management. Documentation ensures standardization, which is paramount to quality management. Policies, procedures, and instructional guides will define the LQMS and give direction for laboratory and supporting processes. This module will also help prepare your laboratory for internal audits and explain the value of External Quality Assessments (EQA).
Module 8: Laboratory Information Management Systems (LIMS)
Information management allows you to effectively manage the flow of samples and associated data to improve lab efficiency. How do we ensure a sample is labeled appropriately? Are tests ordered correctly? Did the results make it to the patient’s chart? How do we preserve records of these encounters? This module will highlight the importance of having an information management system in your laboratory, discuss accurate and secure patient data, data integrity and security, regulatory compliance reporting, how to troubleshoot and maintain your laboratory information system (LIS) and your role as a manager in LMIS maintenance and change control.
Module 9: Tools for Data Management
Laboratories generate a large amount of data that laboratory managers need to make a variety of decisions surrounding quality and patient safety. This module will help you better organize your data so that you can communicate your findings more efficiently and effectively.
Module 10: Making Data-Driven Decisions
Increased speed, optimization, efficiency, and quality often rely on data-driven decisions. This module will help you identify what data sources are important for laboratory effectiveness, how to create a culture of information generation and use. Using data in your decision making process will help you as a lab manager to make better decisions and foster clear communication of those decisions.