Quality Management Systems
Introduction to Quality Management Systems in the Laboratory
Welcome to Module 1.
This is the first of 10 modules that will focus on quality management in the clinical laboratory. We will begin this course by introducing you to the Laboratory Quality Management System (LQMS) framework, which is a set of standardized procedures and practices contributing to the overall quality of laboratory test results. We will refer to the LQMS framework throughout this course.
How do we achieve laboratory excellence? By implementing a LQMS. Implementation of a LQMS will not guarantee an error-free laboratory, but it will detect errors and prevent them from recurring.
Laboratories produce test results that are widely used in both clinical and public health settings, and health outcomes depend on the accuracy of testing and reporting. Small errors such as mixing up a specimen, improper equipment maintenance, or wrongly labeling a patient sample have the potential to cause devastating consequences. Potential consequences of laboratory error include increased cost, time, personnel effort, and patient harm. The LQMS framework helps to prevent errors like these from happening.
We will also introduce the World Health Organization’s (WHO 's) 12 Quality System Essentials (QSEs). The 12 QSEs and the LQMS are essentially the same thing. The difference is that QMS is a terminology from the Clinical & Laboratory Standards Institute (CLSI) while QSEs are from the WHO. All 12 QSEs must be addressed to ensure accuracy, reliability, and timeliness of laboratory test results. A solid comprehension of the 12 essentials of quality management in laboratory environments will help you navigate and successfully lead your team.
To help reflect on the lectures we will be studying, we include an Individual Learning Plan (ILP). The ILP will record your learning process and thoughts throughout this course, allowing you to repeatedly evaluate your skills and approaches in differing situations.
The ILP is a comprehensive tool in a journal format for reflection that will help you think about your leadership and management skills and style. Throughout this course, you will record insights from course activities in the ILP. By the end of the course, you will find that the ILP is a permanent record of your learning and your plans for further professional development.
Completion of the ILP is a course requirement. You will be provided with an optional Word document version of the ILP that you can save for future reference. During the course, you will be asked to respond to the ILP questions within the online learning environment.
Completion of the ILP is a course requirement. You will be provided with an optional Word document version of the ILP that you can save for future reference. During the course, you will be asked to submit the ILP questions within the online learning environment.
Note: If you have trouble watching the lectures due to a slow Internet connection, try downloading the lecture or the transcript listed below each video. Right click the link and select "Save Link as" to download.
If you have trouble watching the lectures due to a slow Internet connection, try downloading the lecture or the transcript listed below each video. Right click the link and select "Save Link as" to download.
Learning Objectives
After completing this module, you will be able to:
- Describe the role that clinical and public health laboratories have in a health system;
- Explain the importance of a LQMS;
- List the 12 QSEs;
- Describe the history of development of quality principles;
- Explain the basic requirements of a LQMS and sources for creating a LQMS; and
- Discuss the relationship of this quality model to the International Organization for Standardization (ISO) and CLSI standards.
Video: Why Quality Management Matters in Health Laboratories (4 minutes)
Universal access to high quality health laboratories is essential for strong health systems and crucial for improving public health. A quality management system is needed to control, assure and manage the quality of laboratory services. In this video, laboratory professionals share their experience and advice on the importance of quality.
Video: Introduction to Laboratory Quality Management Systems (1 minutes)
Downloads: Video (3.8 MB), Audio (1 MB), Transcript
Video: Introduction to Laboratory Quality Management Systems (18 minutes)
Let’s begin this course and module with a short introduction to laboratory quality management systems (QMS). This video lecture will define QMS, describe the benefits of QMS, walk you through ISO and CLSI quality standards, as well as describe the essential elements of a laboratory quality system.
Downloads: Video (44.8 MB), Audio (8.5 MB), Transcript
Optional Resources:
- For students in OECD countries: Clinical and Laboratory Standards Institute (CLSI)
- For students in LMICs: International Organization for Standardization
- Revised ISO 15189 Standards Place More Focus on Mitigating Risk, Patient Care
- Transition to the new ISO 15189:2022 Standards: What does it mean in practice?
- Standardization and harmonization in laboratory medicine: not only for clinical chemistry measurands
- Medical laboratories — Requirements for quality and competence (ISO)
Reading: Review and comparison of quality standards, guidelines and regulations for laboratories (30 minutes)
Implementing a quality management system (QMS) can help a laboratory run more efficiently by reducing costs and nonconformances. Depending on your country, a QMS is a requirement (e.g., CLIA regulations) for passing and maintaining accreditation.
There are multiple quality standards, guidelines, and regulations that a clinical laboratory can follow. The following article provides a succinct review and comparison of various laboratory quality standards both national and international quality documents.
As you read the article, self-reflect on the following questions:
- Increasing health in Low- and Middle-Income Countries (LMIC) originally focused on treatment and care but has now broadened to include laboratory diagnostics. How do you think this has impacted public health in LMIC?
- Describe the differences between international guidelines, international standards, and national regulations. Do you think these three areas cover the nature of all quality documents that exist globally? If not, what other definition(s) might you include?
- What is a non-clinical laboratory and what is the function of non-clinical quality documents?
Source: Datema TAM, Oskam L, Klatser PR. Review and comparison of quality standards, guidelines and regulations for laboratories. Afr J Lab Med. 2011 Dec 13;1(1):3. doi: 10.4102/ajlm.v1i1.3. PMID: 29062723; PMCID: PMC5644525.
Reading: The importance of implementing a quality management system in the laboratory (10 minutes)
Implementing a quality management system (QMS) in the laboratory can help ensure customer satisfaction, achieve regulatory requirements, and create more efficient process controls. A The 12 essential QMS provides a set of building blocks that help the lab fulfill predetermined quality objectives.
Source: Christopher, J. (2018). The Importance of Implementing a Quality Management System in the Laboratory. Medical Laboratory Observer (MLO).
Video: The Importance of Standards (1 minute)
“Increased awareness of the costly personal and economic effects of medical errors has underscored the importance of managing quality in health care services. In the present environment of limited resources, quality cannot be taken for granted by those who fund, receive, or provide laboratory services. The historical perspective of quality control and quality assurance as defining quality needs to be superseded by a more comprehensive view of internationally accepted quality practices applied to a laboratory’s entire scope of work.” (CLSI.org)
The following video comes from CLSI, where Gregory Miller, President of CLSI, explains the importance of standards in laboratories around the world.
Video: What makes a lab manager a leader? (2 minutes)
Watch the following video vignette with guest speaker Dr. Stephen Polyak where he talks about what aspects of leadership make a lab manager a leader.
Downloads: Video (106 MB), Audio (1 MB), Transcript
Video: Managing – one size does not fit all (3 minutes)
Watch the following video vignette with guest speaker Dr. Stephen Polyak where he shares his thoughts on managing in a variety of scenarios and being a manager for everyone on your team.
Downloads: Video (126 MB), Audio (1.1 MB), Transcript
Video: Advice for laboratory managers around the world to improve quality in their clinical laboratories? (1 minute)
Watch a short video vignette with Dr. Michael Astion where he shares advice for improving quality in the laboratory.
Downloads: Video (6.2 MB), Audio (1 MB), Transcript
ILP Assignment: Quality Management in the Laboratory (20 minutes)
Consider the methods and practices mentioned in this module (e.g., implementing a Quality Management System (QMS), adhering to ISO standards, and incorporating the 12 Quality System Essentials). Reflect on how these strategies can be applied in your laboratory to improve accuracy, reliability, and overall quality of results.
Next, go to the ILP Assignment and respond to the questions.
Quiz (15 minutes)
The quiz is due Sunday, January 25, at 11:59 pm PT.
Late submissions will not be penalized.
Go to Quiz
Reading: Module Summary (5 minutes)
To summarize, quality management is not new; it grew from the good works of innovators who defined quality over a span of 80 years. Quality management is as applicable for the medical laboratory as it is for manufacturing and industry. A laboratory is a complex system and all aspects must function properly to achieve quality. A quality management system (QMS) is essential in laboratories to ensure accurate and reliable results, maintain patient safety, and meet regulatory requirements. The QMS helps standardize processes, establish clear responsibilities, and continuously monitor and improve laboratory operations. It can reduce, detect, and prevent laboratory testing errors and can help a lab run more efficiently by reducing costs and nonconformances.
The basic requirements of a Quality Management System in a laboratory include clear documentation of procedures and policies, comprehensive training of personnel, regular equipment maintenance, effective internal and external quality assessment, and robust corrective action processes and you will learn more about these elements throughout the course. The QMS should facilitate effective communication, data management, and ensure compliance with regulatory standards.
Sources for creating a QMS include international standards like ISO 15189, which specifically applies to medical laboratories and emphasizes competence, quality control, and continual improvement. The Clinical and Laboratory Standards Institute (CLSI) also provides guidelines and best practices for laboratory quality management.
The quality model represented by the WHO’s 12 quality system essential (QSE) elements aligns with both ISO and CLSI standards and play a crucial role in ensuring quality in a laboratory. These elements cover all aspects of laboratory operations, from management and personnel competence to equipment, reagents, and information management. By following these QSE elements, laboratories can minimize errors, control risks, and maintain consistent, high-quality results. They also promote a culture of continuous improvement, allowing laboratories to adapt to changing needs and advances in technology. You will learn about the 12 QSEs throughout this course and how they help to ensure a quality system is in place from an operations perspective.
ISO 15189 serves as an international standard that defines the general requirements for quality and competence in medical laboratories. On the other hand, the Clinical and Laboratory Standards Institute (CLSI) develops guidelines and standards specific to the laboratory testing process. The 12 QSE elements are a part of ISO 15189:2012, which incorporates international best practices and aligns with CLSI guidelines, providing laboratories with a comprehensive framework to achieve and maintain high-quality services. This alignment ensures that laboratories can benefit from a globally recognized and consistent approach to quality management, fostering trust in laboratory results and promoting patient safety.
Approaches to implementation of a QMS will vary with the local situation and different laboratories may have different quality requirements. Start with changes that can be easily accomplished and have the biggest impact. Implement in a stepwise process but ultimately, all quality essentials must be addressed. Quality is not a science; it is a way of thinking.