CLSI Training Courses Catalog

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.

Participants will be able to:

• Identify sample collection errors and potential outcomes.
• Describe contents of a sample collection manual.
• Identify records produced in the sample management process.
• Prepare criteria for rejecting unsatisfactory samples.
• Describe the process for sample handling, collection, transport, storage, and disposal.
• Explain the importance of maintaining sample integrity and safety during transport.

Audience: Laboratory Administrative Personnel, Supervisory Personnel, Junior and Senior Technologists, Phlebotomists, Nurses

This workshop shows your laboratory staff how to identify, document, investigate, analyze, correct, and follow up on events that do not conform to the laboratory’s established policies, processes, and procedures.

Participants will be able to:

• Define the term “nonconformance.”
• Describe the tools used to investigate problems.
• Describe the three levels of action to take to address a problem.
• Correctly identify and classify nonconforming events.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

If you are interested in this course, you may also be interested in “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.

Participants will be able to:

• Define QIs
• List examples of QIs for laboratories.
• Identify steps to develop successful QIs.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

If you are interested in this course, you may also be interested in “Nonconforming Event Management— When Things Go Wrong.”

Learn the principles of internal and external audits; the processes and methods to conduct an internal audit; and how to prepare for external audits with this workshop.

Participants will be able to:

• Develop a process to prepare the laboratory 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 action.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

A comprehensive introduction to quality management systems (QMS) based on the quality system essentials (QSEs) and related international standards is presented during this workshop. This introduction lays the foundation for the implementation of QSEs in the laboratory. The workshop describes why implementation of QMS/QSE/standards is a critical step for accreditation preparedness.

Participants will be able to:

• Identify the QSEs that make up a QMS.
• Define how a QMS supports laboratory operations.
• Define roles and responsibilities for quality within a laboratory.
• Correctly use checklists, forms, and records.
• Develop policies and procedures that contribute to quality laboratory operations.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

This workshop introduces participants about using quality control (QC) in clinical laboratory operations. This curriculum includes qualitative and quantitative QC measures, and how to recognize and troubleshoot QC issues.

Participants will be able to:

• Define QC and describe its relationship to an overall quality management system.
• Describe three different QC methods.
• Identify unacceptable QC values.
• Implement appropriate steps for unacceptable QC results.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

Proposed US Food and Drug Administration (FDA) requirements for laboratory-developed tests (LDTs) are explained. Participants will review the elements for FDA’s Quality System Requirements for LDTs and learn best practices for meeting FDA’s Quality System Requirements for LDTs.

This workshop is based on CLSI's product QSR LDT, Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

The general concepts of risk assessment and performing a Failure Mode and Effects Analysis (FMEA) are covered. This workshop provides a basic understanding of risk analysis and is intended for those who have not performed a formal risk analysis before.

Audience: Laboratory Administration, Quality Officers/Laboratory Managers, Laboratory Technologists

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.

Audience: Quality Officers, Laboratory Administration, Laboratory Managers, Laboratory Technologists

To provide basic quality control (QC) and method evaluation knowledge (QC system, method validation, and verification) for different microbiology methods.

Upon completion of the training course, participants will be able to:

• Understand QC practices for manual, semi-automated and automated microbiology testing (eg, culture, Gram stain, biochemical testing, microbial detection and identification, and antibiotic susceptibility testing).
• Establish and maintain a comprehensive QC system (methods and established schedules) for monitoring stains, reagents, and media for expected performance.
• Prepare test method documents, which comprehensively describe the laboratory’s test methods and relevant QC procedures.
• Organize and monitor proficiency testing programs.
• Develop verification and validation protocols for new methods introduced into the organization.

Audience: Laboratory professionals working in microbiology, clinical microbiologists, quality managers, microbiology laboratory department supervisors

This course provides basic and general quality control (QC) and method evaluation knowledge (QC system, method validation and verification) for clinical laboratory testing methods.

Participants will be able to:

• Understand QC practices for clinical laboratory testing (eg, biochemistry).
• Establish and maintain a comprehensive quality control system (methods and established schedules) for monitoring reagents and assays for expected performance.
• Prepare test method documents, which comprehensively describe the laboratory’s test methods and relevant quality control procedures.
• Organize and monitor proficiency testing programs.
• Develop verification and validation protocols for new methods introduced into the organization.

Audience: Laboratory professionals, quality managers, laboratory department supervisors

This course provides laboratorians with basic quality control (QC) and method evaluation knowledge (QC system, method validation and verification) for different molecular diagnostic testing methods with this course.

Participants will be able to:

• Understand QC practices for clinical laboratory testing (eg, biochemistry).
• Establish and maintain a comprehensive QC system (methods and established schedules) for monitoring reagents and assays for expected performance.
• Prepare test method documents, which comprehensively describe the laboratory’s test methods and relevant QC procedures.
• Organize and monitor proficiency testing programs.
• Develop verification and validation protocols for new methods introduced into the organization.

Audience: Laboratory professionals working in molecular diagnostics, clinical molecular biologists, quality managers, molecular laboratory department supervisors

This workshop provides your staff with basic quality control (QC) and method evaluation knowledge (QC system, method validation and verification) for rapid testing (RT) and enzyme-linked immunosorbent assay (ELISA) methods.

Participants will be able to:

• Understand QC practices for RT and ELISA testing methods.
• Establish and maintain a comprehensive QC system (methods and established schedules) for monitoring RT and ELISA reagents and assays for expected performance.
• Prepare test method documents, which comprehensively describe the laboratory’s test methods and relevant quality control procedures.
• Organize and monitor proficiency testing programs.
• Develop verification and validation protocols for new methods introduced into the organization.

Audience: Laboratory professionals working in RT and ELISA, quality managers, laboratory department supervisors

The online, self-paced 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 the implementation of a QMS.

Participants will be able to ensure that their laboratories:

• Meet accreditation quality requirements.
• Run with the highest efficiency and productivity.
• Provide the highest quality test results to their patient population.

Audience: Bench Staff

Help your staff streamline the process of establishing an individualized quality control plan (IQCP) in the laboratory by enrolling them in this workshop. 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 purpose of helping to simplify QC based on risk management.

Audience: Laboratory Managers, Quality Managers

This program will help your laboratory determine how much it spends on supporting good quality, resolving problems and errors, and preventing poor quality from occurring. It will help 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.

Audience: Bench Staff, Laboratory Managers, Quality Managers