Laboratory Quality Management System Training Toolkit

The purpose of this module is to provide the participants with a broad understanding of a laboratory quality management system.
At the end of this module, participants will be able to:

• explain the importance of a quality management system;
• list the quality management system essential elements;
• describe the history of development of quality principles;
• discuss relationship of this quality model to ISO and CLSI standards.

The purpose of this module is to provide the participants with information that contributes to quality laboratory practices and a safe working environment.
At the end of this module, participants will be able to:

• relate how facility design impacts the efficiency and safety of laboratory workers;
• describe practices to prevent or reduce risks;
• list personal protective equipment (PPE) that should be used routinely by laboratory workers;
• explain general safety requirements for the laboratory;
• describe steps to take in response to emergencies such as biological or chemical spills, or laboratory fires.

The purpose of this module is to provide instruction on how to establish a program for managing equipment.
At the end of this module, participants will be able to:

• list items to consider prior to purchasing equipment for the laboratory;
• manage the selection and acquisition of new equipment;
• describe the requirements for a preventive maintenance program for equipment;
• provide a rationale for developing a preventive maintenance program in their laboratory;
• explain how to retire old or outdated equipment.

The purpose of this module is to provide an overview for making purchasing decisions and managing inventory.
At the end of this module, participants will be able to:

• describe the steps required to implement an inventory control program;
• name factors to consider in procurement of supplies;
• develop a monitoring plan for the inventory system;
• discuss the importance of documentation related to purchasing and inventory.

The purpose of this module is to present information that will help participants 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.
At the end of this module, participants will be able to:

• name sample collection errors that could lead to incorrect laboratory examination results;
• list contents that should be included in a handbook designed for people who collect samples off-site;
• provide a rationale for rejecting unsatisfactory samples;
• describe a system for sample handling, including collection, transport, storage, and disposal;
• explain the importance of maintaining sample integrity and assuring that all regulations and requirements are met when transporting samples.

The purpose of this module is to provide participants with a general overview of concepts of quality control. It serves as an introduction to both the Quantitative Quality Control (Module 7) and the Qualitative/Semi-quantitative Quality Control (Module 8).
At the end of this module, participants will be able to:

• define quality control and describe its relationship to the overall quality management system;
• describe differences in quantitative, semi-quantitative, and qualitative examinations.

This module explains how quality control methods are applied to quantitative laboratory examinations, and how to organize a quality control program for quantitative tests.
At the end of this module, participants will be able to:

• differentiate accuracy and precision;
• select control material for a specified examination method;
• establish acceptable control limits for a method when only one level of control material is available;
• explain the use of a Levey-Jennings chart;
• give two examples of rule violations using Westgard Multirule System;
• describe how to correct “out of control” problems.

The purpose of this module is to provide information on how to conduct quality control for qualitative and semi-quantitative testing in the laboratory.
At the end of this module, participants will be able to:

• differentiate between built-in and traditional controls;
• describe how to use stock cultures for microbiology QC;
• discuss the use of quality control procedures for stains used in microscopic examination;
• describe methods for verifying performance of microbiological media.

The purpose of this module is to provide the participants with an overview of laboratory assessment, and information about external and internal audits.
At the end of this module, participants will be able to:

• develop a process to prepare your laboratory staff for an external audit;
• plan and manage an internal audit;
• discuss how to use results from a laboratory audit;
• advocate for the importance of taking corrective actions.

The purpose of this module is to provide the participants with aspects of External Quality Assessment (EQA) that contribute to quality laboratory practices.
At the end of this module, participants will be able to:

• discuss the importance of an EQA program in improving the quality of laboratory test results;
• describe at least three EQA methods and the advantages and disadvantages of each;
• outline a method to investigate an unacceptable test result from an EQA sample.

The purpose of this module is to provide the participants with information on laboratory standards, the organizations that develop them, and how the processes of accreditation and certification are conducted.
At the end of this module, participants will be able to:

• compare and contrast accreditation, certification and licensure;
• describe the process involved in the development of standards;
• discuss the need for laboratory norms and standards.

The purpose of this module is to provide principles of personnel management that contribute to a workforce that is qualified, competent, and understands and follows quality laboratory practices.
At the end of this module, participants will be able to:

• describe the role of personnel in the quality management system;
• develop a plan to verify employee competency;
• describe the steps involved in assessing and maintaining employee competency;
• explain a process to maintain personnel records.

The purpose of this module is to provide the participants with the rationale and the process for developing a program for monitoring and improving customer service.
At the end of this module, participants will be able to:

• recognize the variety of laboratory customer groups;
• develop methods to measure customer satisfaction;
• discuss problems that may develop with customers;
• suggest solutions for customer service problems;
• discuss how quality management processes help the laboratory meet customer group needs and requirements.

The purpose of this module is to provide the participants with both the rationale and the process for developing a program for monitoring and improving occurrence management.
At the end of this module, participants will be able to:

• define the term “occurrence”;
• describe the essential quality monitoring tools;
• differentiate among preventive action, remedial action, and corrective action;
• describe the relationships between preventive action and risk management practices;
• define and describe root cause analysis.

The purpose of this module is to provide an introduction to the concepts of process improvement and a description of some of the tools used to achieve process improvement.
At the end of this module, participants will be able to:

• relate the historical perspective of process improvement;
• describe the importance of process improvement in maintaining quality;
• explain the need for tools to monitor laboratory processes so that problems can be identified and improved.

The purpose of this module is to provide the participants with information for managing documents and records.
At the end of this module, participants will be able to:

• explain the difference between documents and records;
• describe the hierarchy of documents and the role of each level;
• outline the content that should be included in a standard operating procedure;
• explain the important steps, or elements, of a laboratory document management system;
• outline the contents of a quality manual;
• describe methods and tools to properly store documents and records.

The purpose of this module is to provide the participants with an overview of information management and explain how it relates to quality practices in the laboratory.
At the end of this module, participants will be able to:

• describe important elements of an information management system;
• explain things to consider when developing a manual, paper-based information system;
• describe the advantages and disadvantages of a computerized information management system.

The purpose of this module is to describe the organizational structure, management roles and responsibilities, and other factors needed for a successful laboratory quality management system.
At the end of this module, participants will be able to:

• describe organizational elements needed for a quality management system;
• discuss management roles and responsibilities in a quality system;
• explain the process for designing, implementing, maintaining, and improving the laboratory quality system;
• explain the purpose of a quality manual.