Risk Management in Clinical Laboratories

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Essentially all activities in the clinical laboratory carry with them the risk, some have greater potential for harm to patients and clients to various laboratory services. Maintaining a robust, safe, and high-quality laboratory service requires an acknowledgment of these risks and responding to this by embedding processes to measure and identify, analyze, and implement corrective actions to reduce frequency and impacts of risks, and/or provide warning systems to alert to situations where there is increased potential. In this session, we will provide an overview of risk management in healthcare focusing on clinical laboratories. We will discuss the relationship of risk management to standards for best practice. The presentations will provide an explanation of explain how risk management is done and highlight risk management frameworks like Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA), and others. We will finally explore how risk management strategies are used in continuous improvement initiatives, and other projects bringing about change to the laboratory work environment and its processes.

At the end of these presentations, participants will be able to:

1. Describe the importance of a thorough approach to risk management in assuring a Safety Culture.

2. Describe the steps in the risk management cycle including how risks are identified and controlled.

3. Identify the roles of commonly used risk management strategies, like FMEA and RCA, in preparing for, or responding to hazards in laboratory processes.

4. Describe the role of risk management in projects, and the operation of Six Sigma, Lean, and PDCS process improvement initiatives.


Dr. Merve Sibel Gungoren
Head of Immunoassay Department
Duzen Laboratories Group, Turkey
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Prof. Praveen Sharma
Professor of Biochemistry
All India Institute of Medical Sciences, Jodhpur, India
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Prof. Edward Randell
Clinical Chief of Laboratory Medicine
Eastern Health Authority and Memorial University, Canada
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Sedef Yenice (Chair)
Professor of Biochemistry
Demiroglu Bilim University and G Florence Nightingale Hospital, Turkey
View Biography