Risk Management PMTP

• Root Cause Analysis can be done using an Ishikawa/Fishbone diagram.
• Analyze the laboratory process by developing a process map that breaks down all phases of the test or test system into steps, allowing potential failure modes and significant risks to patients to be identified.
• The process can then be further analyzed to see if controls can be put into place to avoid the failures.
• Each step in the process can be analyzed to find potential failure modes that could present significant risk to patients.
• Risk Identification Table is a tool used in Risk Identification.
• Risk management can be a project triggered by an occurrence or finding, a proactive project to evaluate potential weaknesses in a new, revised, or complex processes, or a continuous assessment based on daily events and observation of what is happening in the laboratory.
• Understanding the lab process is typically done through process mapping.
• Risk management is a formal term for what clinical laboratories are already doing every day.
• Managing risks is not only a process, but a mindset that needs to be present throughout the laboratory.
• Risk management attempts to answer the following: What can go wrong, how bad is it, how often, and what should be done to mitigate/reduce the risk.
• Control risks is the third stage in the risk management process.
• Monitor risks is the fourth stage in the risk management process.
• Risk points are identified during the risk identification stage.
• The second stage in the risk management process is evaluating risk points.
• Laboratories need to create a risk management culture.
• Risk identification is the first stage in the risk management process.
• The risk management process consists of four stages: analyze the laboratory process, evaluate risk points, control risks, and monitor risks.
• Risk Management in the Clinical Laboratory is a process that identifies, assesses, mitigates, and monitors risks.
• The intended learning outcomes of Risk Management in the Clinical Laboratory include identifying different tasks performed and estimating the most common causes of errors, creating a quality management system for clinical laboratories, appraising the importance and use of a risk management plan, performing risk-based quality management, and using specific tools and approaches for assessing and controlling risks.
• A hazard is any source of potential damage, harm or adverse health effects on something or someone.
• An exposure is the probability and/or amount of contact between the hazard and the entity it is potentially harming.
• A risk is the chance or probability that a person will be harmed or experience an adverse health effect if exposed to a hazard.
• Risk management can be based on several consensus guidelines or accreditation agencies such as ISO 15189, CLSI EP 18, EP 23, and CAP (College of American Pathologists).
• Risk management in healthcare is an approach in which a specialist addresses the prevention and containment of liability by documenting critical or unusual incidents towards the patient or healthcare worker.
• Risk management is a systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971).
• Risk perception is a highly personal process of decision making, based on an individual’s frame of reference developed over a lifetime, among many other factors.
• The objective of risk management is to reduce different risks related to an act or a failure to act to a level acceptable to the facility.
• Laboratories evaluate the performance of new devices, troubleshoot instrument problems, respond to physician complaints, estimate harm to a patient from incorrect results, and take actions to prevent errors.
• Security measures are proportionate to the actual risks, locally relevant and sustainable over the long term.
• Towards Patient Safety and Towards Laboratory Safety are initiatives that promote risk management in laboratories.
• Risk communication is an essential part of shared decision making and evidence-based patient choice.
• A risk assessment framework is a systematic approach to identify hazards, evaluate risk and incorporate appropriate measures to manage and mitigate risk for any work process or activity.
• Hazard is a source or situation with a potential for causing harm.
• Common laboratory risks include needle pricks, failure of lab procedure, contamination, slips, trips, falls, physical injuries, unauthorized access, damage of property/equipment, loss/leakage/theft of materials/data/information, pathogens, clinical/animal samples, inexperienced staff, irresponsible staff, untrained staff, terrorists, disgruntled staff, staff with debts, and more.
• Most incidents were caused by human factors rather than malfunctions of engineering controls.
• Risk is a combination of the likelihood of an incident occurring and the severity of the consequences (harm) if that incident were to occur.
• Threat is the potential cause of an incident which may result in harm.
• Biorisk management uses a risk-based approach, with risk assessment as the core.
• The actual risk of a given scenario is influenced not only by the agent being handled, but also by the procedure being performed and the competency of the laboratory personnel.
• For biosecurity, threat is used to refer to an individual or group of people who have the motive, means, and opportunity to intentionally cause harm.