CLSI TRAINING COURSES CATALOG

Transcription

1 CLSI TRAINING COURSES CATALOG A Laboratory Development Resource

2 CLINICAL AND LABORATORY STANDARDS INSTITUTE TRAINING COURSES CATALOG The Clinical and Laboratory Standards Institute (CLSI) is known for its international leadership in laboratory quality management and world-renowned expertise in laboratory standards. CLSI is a trusted partner in preparing laboratories for internationally recognized accreditation through training, mentor programs, and technical assistance. CLSI provides numerous programs and services including: Measurable and scalable programs for all laboratories seeking international accreditation On-site assessment to evaluate existing laboratory operations against the accreditation, identifying and analyzing gaps between existing practices and best practices Customized and interactive training and educational programs for laboratory staff, management, and quality officers, focusing on the development and strengthening of quality management systems Development of customized self-assessment tools that the laboratory management team can use to determine what gaps exist between current practices and best practices Assistance with the development of continuous quality improvement strategies Assistance with the development of strategic plans for laboratories Training can be customized to fit your needs. Contact [email protected] for more information [email protected] Contact CLSI for further information regarding course pricing. 1

3 TABLE OF CONTENTS Introduction to Quality Management Systems Purchasing and Inventory Sample Management Nonconforming Event Management When Things Go Wrong Continual Improvement Quality Indicators Assessments Reviewing the Evidence Building a Strong Foundation an Overview of Quality Management Systems Basics of Quality Management Systems (Series of three 1-week workshops) Process Management: Measuring the Quality of Your Laboratory Test Results Quality Management Systems for Laboratory Leaders (Series of three 2-week workshops) Quality Manager One of the Team Laboratory-Developed Testing Risk Management Verification/Validation Protocols What, When, Where, and How Laboratory Quality Management System Online Certificate Program EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements Implementing the Cost of Quality in the Laboratory Online Certificate Program COURSE CATALOG Clinical and Laboratory Standards Institute

4 Contact CLSI for further information regarding course pricing. 3

5 WORKSHOPS Introduction to Quality Management Systems This high-level workshop provides interactive instruction that focuses on the quality management system elements for a safe and efficient clinical laboratory working environment. Participants learn about the 12 quality system essentials and their role in laboratory operations. Length: 1 Day Learning Level: Basic Audience: Laboratory Administrators, Administrative Directors, Quality Managers Purchasing and Inventory This workshop discusses the rationale and the process for developing a program for monitoring and improving purchasing and inventory control. CLSI uses QMS01, Quality Management System: A Model for Laboratory Services for training and implementation of a comprehensive system for the management of reagents and supplies. Upon completion of this workshop, participants will be able to: a) discuss the importance of documents relating to supply management; b) describe steps required to implement an inventory control program; c) identify factors to consider in procurement of supplies; d) develop a monitoring plan for supply inventory; and e) discuss the importance of documentation relating to supply management. Length: 1 Day Audience: Laboratory Administrative Personnel, Supervisory Personnel, Senior Technologists 4 COURSE CATALOG Clinical and Laboratory Standards Institute

6 Sample Management This workshop shows participants how to develop a sample collection manual and implement a process to properly manage samples. Items discussed and practiced include sample integrity, accuracy, and biosafety. Upon completion of this workshop, participants will be able to: a) identify sample collection errors and potential outcomes; b) describe contents of a sample collection manual; c) identify records produced in the sample management process; d) prepare criteria for rejecting unsatisfactory samples; e) describe the process for sample handling, collection, transport, storage, and disposal; and f) explain the importance of maintaining sample integrity and safety during transport. Length: 1 Day Audience: Laboratory Administrative Personnel, Supervisory Personnel, Junior and Senior Technologists, Phlebotomists, Nurses Nonconforming Event Management When Things Go Wrong This workshop describes how to identify, document, investigate, analyze, correct, and follow up on events that do not conform to the service s established policies, processes, and procedures. Upon completion of this workshop, participants will be able to: a) define the term nonconformance ; b) describe the tools to investigate problems; c) describe the three levels of action to take to address a problem; and d) correctly identify and classify nonconforming events. Length: 1 Day NOTE: This course works well with and relates to the course Continual Improvement Quality Indicators [email protected] Contact CLSI for further information regarding course pricing. 5

7 Continual Improvement Quality Indicators This workshop introduces the concept of quality indicators (QIs) in the laboratory, and explains how to establish and use QIs to improve quality in all laboratory operations. Upon completion of this workshop, participants will be able to: a) define QIs; b) list examples of QIs for laboratories; and c) identify steps to develop successful QIs. Length: 1 Day NOTE: This course works well with and relates to the course Nonconforming Event Management When Things Go Wrong. Assessments Reviewing the Evidence This workshop introduces the principles of internal and external audits; the processes and methods to conduct an internal audit; and how to prepare for external audits. Upon completion of this workshop, participants will be able to: a) develop a process to prepare the laboratory for an external audit; b) plan and manage an internal audit; c) discuss how to use results from a laboratory audit; and d) advocate for the importance of taking corrective action. Length: 1 Day 6 COURSE CATALOG Clinical and Laboratory Standards Institute

8 Building a Strong Foundation an Overview of Quality Management Systems This workshop provides a comprehensive introduction to quality management systems (QMS) based on the quality system essentials (QSEs) and related international standards. This introduction lays the foundation for the implementation of QSEs in the laboratory to help ensure sustainable quality operations in resource-limited environments. The workshop describes why implementation of QMS/QSE/standards is a critical step on the road to accreditation preparedness. Upon completion of this workshop, participants will be able to: a) identify the QSEs that make up a QMS; b) define how a QMS supports laboratory operations; c) define roles and responsibilities for quality within a laboratory; d) correctly use checklists, forms, and records; and e) develop policies and procedures that contribute to quality laboratory operations. Length: 5 Days Learning Level: Basic [email protected] Contact CLSI for further information regarding course pricing. 7

9 Basics of Quality Management Systems (Series of three 1-week workshops) The main objective of this workshop is to support the development of a documents and records management system in compliance with standards/requirements of the laboratory s selected recognition program. This workshop is structured with presentations, small group work, and individual work. The intent is to support participants in the development of a documents/records management system designed for their specific laboratory needs. Intermediate projects are included in this course. Length: 3- to 5-Day workshops /Advanced Audience: Laboratory Managers, Quality Managers Process Management: Measuring the Quality of Your Laboratory Test Results This workshop introduces and teaches participants about the significant role quality control (QC) plays in clinical laboratory operations. This curriculum includes qualitative and quantitative QC measures, and how to recognize and troubleshoot QC issues. Upon completion of this workshop, participants will be able to: a) define QC and describe its relationship to an overall quality management system; b) describe three different QC methods; c) identify unacceptable QC values; and d) implement the steps to take when unacceptable QC results are obtained. Length: 3 Days 8 COURSE CATALOG Clinical and Laboratory Standards Institute

10 Quality Management Systems for Laboratory Leaders (Series of three 2-week workshops) This Certificate Program teaches the 12 quality system essentials, as recognized by CLSI, is aligned with CLSI standards, and is compatible with ISO This Certificate Program supports the achievement of a higher level of laboratory operations up to and including accreditation. It builds a strong foundation for laboratory functions by focusing on the oversight, decision making, and policy making as part of an integrated approach to the delivery of high-quality patient results. This Certificate Program empowers individuals by providing the knowledge and tools to find answers to questions and generate ideas for improvement so laboratories will operate efficiently and successfully. The CLSI Program Certificate is awarded to participants who successfully complete the three courses: Course 1: Organizational Dynamics and Leadership Course 2: Operations and Technical Management Course 3: Quality Management Principles, Practices, and Oversight Length: 1 Year; six 2-week courses and a close-out retreat /Advanced [email protected] Contact CLSI for further information regarding course pricing. 9

11 Quality Manager One of the Team This workshop is a two-part series designed to prepare a Quality Manager to function effectively as a Quality Manager in his/her workplace. This first course includes both the Quality Manager and the Laboratory Director/Manager, preparing them to establish an effective quality program in their laboratory, understanding the ISO requirements of both positions and the interconnectedness of their roles and responsibilities. Length: 10 Days /Advanced Audience: Quality Managers (10 days) and Laboratory Directors/Managers (1.5 days) Laboratory-Developed Testing This workshop covers the proposed US Food and Drug Administration (FDA) requirements for laboratory-developed tests (LDTs) and explains how FDA s Quality System Requirements apply to LDTs. Participants will review the included elements for FDA s Quality System Requirements for LDTs and learn some best practices for meeting FDA s Quality System Requirements for LDTs. This workshop is based on the CLSI product QSR LDT, Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory, which reviews the FDA s Quality System Requirements for LDTs and includes some suggested best practices for meeting those requirements. Length: 2 Hours 10 COURSE CATALOG Clinical and Laboratory Standards Institute

12 Risk Management This workshop covers the general concepts of risk assessment and performing a Failure Mode and Effects Analysis (FMEA). This workshop provides a basic understanding of risk analysis and is intended for those persons who have not performed a formal risk analysis before. Length: 1 Hour Audience: Laboratory Administration, Quality Officers/Laboratory Managers, Verification/Validation Protocols What, When, Where, and How This workshop describes verification and validation methods for reagents, test kits, and equipment following CLSI guidelines EP05, Evaluation of Precision of Quantitative Measurement Procedures and EP12, User Protocol for Evaluation of Qualitative Test Performance. Length: 2 Days [email protected] Contact CLSI for further information regarding course pricing. 11

13 ONLINE LEARNING Laboratory Quality Management System Online Certificate Program The Laboratory Quality Management System Certificate Program describes the skills needed for successful implementation and sustainment of a quality management system (QMS) in your laboratory. This program focuses on providing a systematic, process-oriented approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective laboratory services through implementation of a QMS. Upon completion of this online, self-paced program, participants will be able to ensure that their laboratories: a) meet accreditation quality requirements; b) run with the highest efficiency and productivity; and c) provide the highest quality test results to their patient population. Length: 13 Hours Learning Level: Beginner Audience: Bench Staff EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements This program helps streamline the process of establishing an individualized quality control plan (IQCP) in the laboratory. As the current equivalent quality control in the Clinical Laboratory Improvement Amendments (CLIA) guidance will soon not be an acceptable option for compliance, the EP23 Online Workshop is an invaluable tool to guide users through the process of establishing an IQCP. This workshop allows for anyone, anywhere, anytime to learn about IQCP, CLSI document EP23, and its intent to help simplify QC based on risk management. Length: 5 Hours Audience: Laboratory Managers, Quality Managers 12 COURSE CATALOG Clinical and Laboratory Standards Institute

14 Implementing the Cost of Quality in the Laboratory Online Certificate Program This program helps your laboratory determine how much it spends on supporting good quality, resolving problems and errors, and preventing poor quality from occurring. It helps your organization improve profitability and enhance your ability to provide better patient care. This is the only program that truly implements the steps needed to determine the existing cost of quality in your laboratory. Length: 4 Hours Learning Level: All Levels Audience: Bench Staff, Laboratory Managers, Quality Managers [email protected] Contact CLSI for further information regarding course pricing. 13

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