ISO 15189:2022 – Medical Laboratory Quality & Accreditation
Laboratory Risk Management, Errors and Patient Safety
SPEA Approved Certificate
Overview
Practical approaches to identifying laboratory risks, analyzing errors, and developing corrective and preventive measures to enhance patient safety and result reliability
- This training course aims to strengthen medical laboratory professionals’ knowledge and skills in managing risks and errors that may affect examination quality and patient safety.
- The course addresses risk identification and assessment, laboratory error classification, root cause analysis, incident and nonconformity management, and the development of corrective and preventive measures in line with relevant ISO 15189:2022 risk management requirements.
- Through case studies and practical exercises, participants learn to apply risk assessment tools, develop risk registers, investigate laboratory incidents, and identify appropriate actions to reduce errors and improve performance.
- The course focuses on risk management and patient safety without covering advanced statistical quality control or internal auditing techniques, which are addressed in separate specialist programs within the training package.
- This professional development course does not grant formal laboratory accreditation.
Who Should Attend
- Medical laboratory managers and supervisors.
- Laboratory quality and risk management officers.
- Medical laboratory scientists and technicians.
- Patient safety and compliance professionals.
- Personnel involved in incident and nonconformity investigations.
- Members of laboratory and hospital quality improvement teams
Learning Outcomes
- By the end of the course, participants will be able to: Explain risk management principles and their relationship to laboratory quality and patient safety.
- Identify and classify risks and errors associated with laboratory processes.
- Apply basic risk assessment tools to prioritize risk management actions.
- Investigate incidents and nonconformities using root cause analysis techniques.
- Recommend appropriate corrective and preventive measures and evaluate their effectiveness.
- Develop an initial risk register and improvement plan to enhance patient safety and reduce laboratory errors.
Course Outline
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Module 1: Risk Management and Patient Safety
• Risk management principles and relevant ISO 15189:2022 requirements. • Relationship between laboratory errors and patient safety. • Identifying and classifying risks across laboratory processes.
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Module 2: Risk Assessment and Error Analysis
• Risk assessment tools and evaluation of likelihood and impact. • Classification of errors, incidents, and nonconformities. • Root cause analysis and prioritization of risk controls.
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Module 3: Incident Management and Corrective Actions
• Incident and error reporting and documentation. • Developing risk controls and measures to prevent error recurrence. • Monitoring action implementation and evaluating effectiveness.
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Module 4: Practical Applications and Continual Improvement
• Case studies involving laboratory errors and incidents. • Developing risk registers and applying assessment tools. • Preparing a concise plan to improve safety and reduce errors.
Assessment
• Short knowledge checks covering risk management principles. • Case study involving laboratory error or incident analysis. • Practical exercise on developing a risk register and corrective actions. • Final assessment of the intended learning outcomes.