Instructor: James O. Westgard, Ph.D.
Duration: 4 Lessons
Release Date: 10/29/2009
This course is accredited by the AACC for 6 ACCENT credits.
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Enroll in this Course immediately by clicking here. [Please note: the course takes a separate username and password than you use at www.westgard.com]
You can also enroll through the online store at www.westgard.com, where coupon discounts may be available (but access may require additional days for processing).
The Introduction to Risk Analysis short course is an online training program intended for professionals in Clinical Laboratory Science (CLS).
Risk Analysis and Risk Management are not new techniques, but they are newly relevant to the healthcare laboratory. Particularly in laboratories where ISO standards are gaining prominence, Risk Management is one of the recommended techniques to improve your Quality System. Within the US, laboratories that are seeking alternatives to traditional QC practices have been directed to Risk Management. CLSI is developing new guidelines for the use of Risk Management in Quality Control.
Participants must pass a final exam to receive continuing education credits for this course. The internet materials are being provided here on this website and on the main website of Westgard QC.
This course is intended to provide education and training in Risk Management principles and techniques, particularly Risk Analysis as it relates to laboratory quality control (QC). In addition, the relationship of laboratory regulation and guidelines to Risk Management will be detailed.
The course is aimed at a broad audience of healthcare practitioners who perform laboratory tests in central laboratories, clinic or outpatient laboratories, and point-of-care settings.
When you complete this course, you will be able to:
- Identify the different QC options or choices by which medical laboratories can be in compliance with the US CLIA regulations;
- Identify the technical requirements for assuring quality under the ISO global standard for accreditation of medical laboratories;
- Recognize the influence of ISO standards on implementation of Risk Analysis and Management by manufacturers;
- Identify the new CLSI guidelines for development of laboratory QC plans based on Risk Analysis and Management.
- Identify the components of a TQM process for continuous improvement.
- Assess your opportunity to improve quality management through defining quality goals and implementing a quality design process.
- Learn a step-by-step process for designing an analytical quality control system.
- Understand the concepts and terminology of Risk Management.
- Review industrial guidelines for Risk assessment.
- Identify the most commonly used tool for Risk assessment.
- Review the industrial guidance for rating severity, occurrence, and detectability.
- This course description provides a summary of each of the lessons.
- The list at right provides links to all of the lessons/courses (links will appear once you are registered)
- Each lesson plan provides a summary of that lesson, specific objectives, links to the course materials that are to be used, a list of things to do, and some questions for self- assessment.
Introduction to Risk Analysis and Risk Management
|1. The Risks of Current QC Practices
- In Quality Control, Compliance Confusion? participants will learn the different QC options or choices by which medical laboratories can be in compliance with the US CLIA regulations.; the technical requirements for assuring quality under the ISO accreditation of medical laboratories; and identify the new CLSI guidelines for development of laboratory QC plans based on Risk Management.
- In Quality Control: today's context, participants will learn to identify the relevant ISO standards for Risk Management as well as the new CLSI guidelines for development of laboratory QC plans based on Risk Management.
|2. Design and Management of Quality Systems
- In A Framework for Analytical QC and Quality Systems participants will learn the components of systems-based process for continuous improvement.
- InDesigning an Analytical QC and Quality System, participants will learn to define quality goals and implement a quality design process, and learn a step-by-step process for designing an analytical quality control system.
|3. What is Risk Management?
- In A Brief History of Risk, participants learn where Risk Management principles and practices came from.
- In What is Risk?, participants learn the industrial guidelines for Risk assessment, as well as the most commonly used tools for Risk assessment.
- InHow is Risk Assessed?, participants will learn the different raing scales for severity, occurrence, and detectability, as well as the relationship between Sigma-metrics vs occurrence and detectability vs SQC in the application of Risk Management.
|4. Quality Management and Risk Analysis
- In Quality Goals and Safety Nets, participants will Recognize the value of traditional analytical quality management and the need to define analytical quality goals, evaluate method performance, and design statistical QC to assure achievement of the desired quality.
Review the approaches for defining analytical goals.
- In Evaluating Analytical Performance Characteristics, participants review the principles for assessing methods and optimizing QC performance.
- In Formulating an Analytical Quality Control Strategy, participants assess the risks of not detecting medically important errors.