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Laboratory Systems (Classroom)

This classroom-based course provides an overview of laboratory systems and operations and an in-depth demonstration of the Quality System Essentials that are critical for effective management of a public health or clinical laboratory and are based on internationally recognized standards.

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Course Overview

Achieving, maintaining, and improving diagnostic testing accuracy, timeliness, and reliability are major challenges for clinical and public health laboratories. As signatories to the International Health Regulations, countries worldwide are committed to build national capacities for the detection of, and response to, public health events of international concern. Countries must produce diagnostic test results that the international community can trust in cases of international emergency. Only a sound management of quality in health laboratories improves patient care and treatment, disease surveillance, and response. 

Training laboratory managers and supervisors in quality management is a step toward achieving international recognition for quality in laboratory practice. This course provides an overview of laboratory systems and operations and an in-depth demonstration of the Quality System Essentials that are critical for effective management of a public health or clinical laboratory and are based on the internationally recognized standards ISO 15189 and CLSI GP26-A3. 

Course Description and Goals

The overall goal of this course is to educate Certificate Program trainees on the role that clinical and public health laboratories play in a national public health system, both in the US and globally. Trainees learn about and discuss topics involving infectious disease diagnosis, surveillance, outbreak response, laboratory information systems and communications, and how laboratory information contributes to health policy development. 

This course also covers topics related to improving quality in laboratory practice and includes an in-depth demonstration of the Laboratory Quality Management System (LQMS) toolkit developed by the Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, Clinical Laboratory Standards Institute, and World Health Organization (WHO). This course addresses functional clinical laboratory topics such as the quality management system essentials, international standards, facilities, biosafety, specimen collection/transportation/management, purchasing and inventory, equipment maintenance, documents and records, information systems, and quality assessment programs. 

While examples from the US healthcare system are used to demonstrate the processes involved, areas of opportunity to improve laboratory capacity in low- and middle-income countries are featured. The goal of the course is to provide trainees with a greater understanding of the functional components of a laboratory system and understand better the importance and implementation of quality in laboratory practice. 

Course Learning Objectives

Participants completing the course at the highest level of achievement should be able to:

  • Describe the role that the clinical and public health laboratory have in a health system
  • Outline essential elements of a well-functioning public health laboratory system and understand their importance in the context of a public health program
  • Describe the importance of quality laboratory information on public health policy making
  • List the quality management system essentials and demonstrate how to design, implement, maintain, and improve a quality management system tailored to their laboratories’ needs
  • Use quality improvement tools and techniques, including process mapping, benchmarking, root cause analysis, and gap analysis
 
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