Podcast
Questions and Answers
What is the purpose of the patient safety event management policy?
Which of the following is NOT included in the policy for patient safety event management?
What is meant by 'Serious Reportable Events' as per the policy?
What action should be taken following a safety event involving severe harm or death?
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What role do Continuous Improvement activities play in the patient safety event management policy?
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Who is responsible for investigating adverse events according to the policy?
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How does the policy suggest sharing findings from safety event investigations?
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What should be done for matters involving maternal and neonatal deaths as per the policy?
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What is the primary focus of the term 'Continuous Improvement' in healthcare?
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Which acronym refers to the systematic approach to solving problems that includes Define, Measure, Analyse, Improve, and Control?
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What defines a 'Never Event' in healthcare?
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What does the acronym HAI stand for?
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Which of the following is an example of an Invasive Procedure?
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What is the role of an IPM (Infection Prevention Control Manager)?
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What does the term 'Near Miss' refer to?
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Which of the following best describes 'Patient Safety Culture'?
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What is the purpose of the Safety Event Management System called TPSC?
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Which term is best defined as 'any source of potential damage or harm'?
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Which role focuses on assessing and improving the safety of patient care directly?
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What is the effect of a 'Serious Reportable Event'?
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What is meant by the term 'Adverse Event'?
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What role does an OHSC (Office of Health Standards Compliance) play?
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What must the Reporter include to receive feedback on the reported event?
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During the After Action Review (AAR), which of the following questions focuses on learning from the event?
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Which of the following is NOT a requirement for reporting an event?
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What types of events must have all AAR questions completed?
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What is the primary purpose of the First Team Review?
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Which of the following describes the actions taken by the Unit/Line Manager after reporting an event?
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What framework helps identify contributing factors during event analysis?
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When should legal support be sought after an event occurs?
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Which of the following events might require further investigation?
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What is a responsibility of the Unit/Line Manager during the Initial Review of an event?
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How should events with serious harm or death be documented in the Safety Event Management System?
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Which statement reflects the approach of Just Culture in event management?
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What should be done if an event's report contains missing details?
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What is the primary focus of a systems analysis in the context of patient safety events?
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What must occur if there are contributing factors identified during the AAR?
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Which of the following events is classified as a Serious Reportable Event (SRE)?
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What constitutes a Near Miss in safety event classification?
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During the Step 1 of safety event management, what is essential for the healthcare worker (HCW) to do first?
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Which step comes after reporting the event in the safety management process?
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What is the expected maximum duration of mild harm classed as Low Harm?
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For which type of incidents is a Serious Event Management Team primarily responsible?
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What type of event is categorized as having No Harm?
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Which of the following actions is NOT recommended after a safety event causes harm to a patient?
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Which classification denotes severe harm that may be permanent?
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What action should the healthcare worker take after completing the event report?
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What is one key characteristic of the Serious Reportable Events (SREs)?
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Which of the following describes the function of the Safety Event Management System?
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What is expected to be the outcome of the final team review in the event management process?
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What must occur during the final review of a safety event?
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Which report is preferred for documenting serious harm and death events?
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What is essential for actions preventing future harm events?
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When must all safety events be loaded and managed to closure?
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Who should obtain guidance from the Legal Department?
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What triggers the sending of alerts within the Safety Event Management System?
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What type of report compiles outcomes of investigations and identifies contributing factors?
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What is the role of the Unit Manager in the management of safety events?
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Who is responsible for maintaining the alert distribution email group?
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What information must be recorded in the CURA risk register?
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How is the Provisional report characterized?
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What action should be taken if an event requires additional time for investigation?
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What is typically included in the feedback provided to staff and patients following an event review?
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What does the acronym SMART stand for in the context of developing actions for safety events?
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In the DMAIC methodology, which step focuses on measuring the performance and understanding the problem before improvement?
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Which actions are required within 48 hours of reporting a Never Event?
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What type of maternal death is classified as a death resulting from pregnancy complications?
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What is required after investigating a maternal death in Namibia in addition to reporting it on the Safety Event Management System?
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Which neonatal event does NOT need to be reported according to the guidelines?
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Who is primarily responsible for managing healthcare-associated infections?
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What is true regarding the final report after discussing a Never Event?
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What is a key responsibility of Unit Managers in the continuous improvement process?
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What categorizes an accidental maternal death?
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What is a requirement when reporting neonatal mortalities?
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When must improvement initiatives be driven according to the document?
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What must happen at the Mother and Baby Collaborative Meeting regarding maternal deaths?
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How often should the status of actions regarding safety events be tracked?
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Who is primarily responsible for leading the investigation of Healthcare-Associated Infections (HAIs)?
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What must the Unit Manager do to support the IPCM during HAI investigations?
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What type of events are classified as Serious Reportable Events (SREs)?
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Which of the following is considered a behaviour event in the context of patient safety?
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What is the consequence of an event involving the incorrect administration of a blood product?
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Which statement reflects proper practice for managing a missing patient situation?
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What is a key responsibility of the IPCM in the context of infection prevention and control?
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Which of the following is NOT classified as a type of serious reportable event?
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Which event directly relates to the unauthorized use of a patient’s medical information?
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What constitutes a never event?
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What aspect of care should always be monitored during and post a blood transfusion?
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What is the primary goal of applying interventions after an HAI investigation?
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Which of the following situations would be classified as a medical device event?
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What should be included in the total count of Serious Reportable Events (SRE)?
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Which of the following best describes a perinatal event?
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What is categorized as a Never Event within surgical procedures?
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Which situation is considered a physiological complication not present prior to surgery?
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Which of the following is NOT a factor to be reported during anesthesia care?
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What type of injury is classified as hospital-acquired and involves deterioration?
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What action should be taken when an event involving expired medication occurs?
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What constitutes a breach of confidentiality in patient safety event management?
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What should be done after an occupational injury has been reported?
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Which of the following is considered a non-safety event?
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Which situation is defined as a Never Event related to medication?
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What should be done if a patient is sent home with the wrong parents?
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What is required when an event of an iatrogenic pneumothorax occurs?
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What characterizes an operating room fire as a never event?
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What is a key requirement for an event to be categorized as a Never Event?
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What condition must be met to classify pressure injuries that were present on admission?
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What is the primary role of the PSM in the event classification process?
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Within what timeframe must the PSM review and classify the event after it has been reported?
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What must happen if the event results in serious harm or death?
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What is a Multi-Event as described in the classification principles?
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What is the purpose of the Serious Event Management Team (SEMT)?
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Who is responsible for scheduling a meeting with the healthcare workers involved in the event?
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What should be included in the preliminary investigation conducted by the PSM?
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What must be documented in the Event Management System after SEMT actions are planned?
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If agency staff members are involved in an event, what is their required action?
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What should be identified during the collation of information step?
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Which document layout is required for initial reports about serious harm events?
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What does the acronym ISBAR stand for in the reporting context?
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Which role is NOT included in the SEMT?
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What must the PSM consult with when determining the appropriate harm level?
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What is a potential consequence of unintentional connection to an air flowmeter for a patient requiring oxygen?
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What is excluded from the patient safety events regarding unintentional connections?
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Which level of patient behavior requires reporting to the OHSC involving physical contact towards staff?
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In the context of medical gases, what does an illegible product label lead to?
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What type of incident would involve reporting to the SANBS?
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What should be reported if there is a contamination of a medical product?
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Which of the following is categorized as a Level 1 patient safety event?
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Which level of behavior includes sexual assault by a visitor towards a patient?
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What is the adequate action for an incorrect surgical procedure performed on a patient?
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In case of an adverse drug reaction during patient monitoring, who should the issue be reported to?
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What constitutes an unintended retained foreign body after a surgical procedure?
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Which of the following scenarios qualifies as a Never Event regarding medication administration?
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Which of the following procedures is not classified as a surgical/invasive procedure?
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What is a key factor regarding falls from poorly restricted windows in healthcare settings?
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What best describes the handling of mismatched organ transplants under the policy?
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What defines the start of surgery?
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What condition leads to chest or neck entrapment in bed rails?
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Which scenario would constitute a 'wrong patient' invasive procedure?
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Which situation can lead to a patient being scalded by water?
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What is an example of a situation that would not be classified as a wrong site or side procedure?
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Which action must be taken to ensure the correct implant/prosthesis is used?
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Which of the following describes the mis-selection of a potassium solution?
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What is significant about the installation of collapsible shower or curtain rails?
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What is a correct definition of a wrong surgery or invasive procedure?
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Which example is excluded from the definition of a wrong patient invasive procedure?
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What defines a misplaced naso- or oro-gastric tube?
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What should be recorded if unknown/unexpected anatomical abnormalities are discovered?
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When should actions to locate retained foreign objects be recorded in the patient notes?
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What best describes 'never events' in surgical procedures?
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What aspect of bedrail design may contribute to a patient’s entrapment?
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What issue arises from incorrect preprocedural measurements?
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Which procedure would fall under the category of wrong site or side invasive procedures?
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Which factor is not a consideration before a surgical procedure?
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What can lead to the incorrect administration of IV medication?
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In the case of incomplete surgical procedures, why may one of the procedures not be performed?
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Which of the following scenarios illustrates the concept of wrong implant or prosthesis?
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What is a crucial responsibility of the surgeon during an invasive procedure?
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Study Notes
Purpose of Policy
- The policy documents and shares standardised patient safety definitions and processes for identification, reporting, investigation, escalation, and improvement following safety events.
- This policy aims to ensure patient, family, and healthcare worker safety.
- It includes definitions of various events, roles and responsibilities, reporting and investigation processes, and escalation procedures.
- The policy emphasises continuous improvement through systemic learning, using principles like DMAIC and A3 problem-solving.
- It also outlines how to report incidents to the Legal Department and its role in managing legal risks.
Policy Statement
- Mediclinic Southern Africa (MCSA) prioritizes patient, employee, visitor, and contractor safety.
- It aims to investigate events leading to harm (adverse events) or near misses, and to prevent their recurrence.
- MCSA emphasizes systemic improvement initiatives, using contemporary Continuous Improvement science principles, after learning from harm events.
- The Legal Department must be consulted in cases of potential harm to patients or visitors.
Acronyms
- DMAIC: Define, Measure, Analyze, Improve, Control
- DRM: Doctor Relationship Manager
- HCW: Healthcare Worker
- IPC: Infection Prevention and Control
- HAI: Healthcare-associated infections
- ISBAR: Identity, Situation, Background, Assessment, Recommendation
- IPCM: Infection Prevention Control Manager
- MCSA: Mediclinic Southern Africa
- NM: Nursing Manager
- DNM: Deputy Nursing Manager
- OHSC: Office of Health Standards Compliance
- PSM: Patient Safety Manager
- PxM: Patient Experience Manager
- RCA: Root Cause Analysis
- RCM: Regional Clinical Manager
- SAHPRA: South Africa Health Products Regulatory Authority
- SEMT: Serious Event Management Team
- SRE: Serious Reportable Event
- TPSC: The Patient Safety Company (safety event reporting system)
- UM: Unit Manager
Definitions
- Adverse Event: An event resulting in unintentional harm to the patient due to an act of commission or omission.
- Clinical Risks: The likelihood of an Adverse Incident causing injury or harm to the patient.
- Continuous Improvement: Ongoing improvement of products, services or processes through incremental and breakthrough enhancements. It involves a systematic, sustainable approach to enhancing the quality of care.
- Harm: Any physical or psychological injury or damage to health, including both temporary and permanent injuries.
- Hazard: Any potential source of damage, harm, adverse health effects, or threat to safety.
- Invasive Procedure: Interventions that permanently alter a patient's anatomy, including surgical procedures done outside of a surgical environment.
- Invasive Procedure Start Time: The point at which a patient's anatomy begins to be permanently altered (e.g., incision, tissue puncture, insertion of an instrument into tissues).
- Near Miss: An event that did not reach the patient, either through luck or early detection.
- Never Events: Preventable patient safety incidents caused by the failure to follow known and readily available guidelines. Each type has the potential for serious harm or death.
- Non Safety Events: Events that occur without a direct impact on a patient, such as equipment breakages, medication expiration, or infrastructure damage.
- Patient Safety: Preventing and mitigating harm caused by healthcare errors. It involves creating systems and processes to minimize error likelihood and maximize the chances of intercepting errors when they occur.
- Patient Safety Culture: A collaborative environment where clinicians treat each other with respect, leaders promote teamwork and psychological safety, teams learn from errors, and improvement is driven through debriefings.
- Psychological Safety: A shared belief that a team is safe for interpersonal risk taking, promoting candid feedback, admitting mistakes, asking for help, and learning from each other.
- Safety Event: An unanticipated, undesirable, or potentially dangerous occurrence in a healthcare organization.
- Safety Event Management System: The TPSC (The Patient Safety Company) software, which is a central reporting system for near misses and events.
- Serious Reportable Events: Events with serious harm or death consequences to patients, families, staff, or the organization, requiring comprehensive response and additional resources to ensure appropriate action and learning. These include Never Events.
- Systems Analysis: Examining the factors contributing to a Patient Safety Event. It focuses on understanding how a system works and how elements interact, and it helps shift from blaming individuals to analyzing systems to prevent errors.
Classification of Safety Events
- Near Miss
- Adverse Event
- Serious Reportable Event (SRE): Includes previously classified Never Events plus other internationally reportable events. It also includes events reportable to regulatory authorities like SANBS, SAPHRA, and OHSC early warning indicators.
- Non Safety Events: Events without a direct impact on patient safety.
Levels of Harm
- No Harm: The event reached the patient but did not cause detectable harm.
- Low Harm: Mild impact, full recovery expected.
- Moderate Harm: Short-term harm, full recovery expected, but may require intervention and increase length of stay.
- Severe Harm: Unlikely to regain previous independence, permanent harm or shortened life expectancy.
- Death: Death was not expected as an outcome, but was caused or brought forward by the event.
Overview of Safety Event Management
- Step 1: Event identification and immediate action to mitigate harm.
- Step 2: Reporting the event on the TPSC system.
- Step 3: Initial review and After-Action Review (AAR) by the Unit/Line Manager.
- Step 4: Categorization and provisional reporting.
- Step 5: First team review to determine the level of investigation needed.
- Step 6: System analysis investigation by the review team.
- Step 7: Final team review, report completion, closing of the event, and providing feedback.
- Step 8: Improvement actions and learning to prevent future events.
Management and Reporting of Safety Events
-
Initial Management:
- The HCW who identifies a safety event must immediately notify their line manager.
- A clinical care plan is developed to monitor the patient's response and prevent further harm.
- The patient's doctor must be notified.
- If there is harm, the patient and/or family must be informed about the event and the investigation.
- Legal advice must be sought from the Legal Department.
-
Reporting:
- The HCW involved completes a Safety Event Report on the TPSC system, documenting the event, affected individuals, and a narrative description.
- The report should be submitted before the end of the shift.
- No names of patients, staff, or doctors should be included to maintain confidentiality.
- The reporter classifies the event based on their opinion.
- Reporters can receive feedback on the event by including their email address.
- Events can be reported anonymously, but minimum patient information is required.
-
Initial Review and AAR:
- The Unit/Line Manager conducts an Initial Review to ensure completeness and correctness.
- An AAR session is held with staff involved to discuss the event, identify gaps, and lessons learned.
- The AAR documentation includes:
- The planned action and actual action.
- The difference between the plan and action.
- Lessons learned.
- Actions to prevent future harm.
- Contributing factors using the Yorkshire Contributing Factors Framework.
-
First Team Review:
- The Unit/Line Manager reports the event to the Review Team (nursing management, PSM, IPCM, Night Manager, and Hospital Clinical Manager).
- This review ensures Just Culture principles are adhered to, determines the level of review, closes the action loop, and disseminates recommendations and learning.
- The team evaluates:
- If the response and recovery actions are appropriate.
- Actions taken to prevent future harm are suitable.
- HCWs involved have received appropriate psychological support per Just Culture principles.
- All associated contributing factors are identified using the Yorkshire Contributing Factors Framework.
- The team decides if further investigation is required (e.g., if there is severe harm, death, or a repeating event).
- The team also prioritizes legal support for all events where harm or potential harm has occurred.
-
Further Investigation:
- If there is severe harm, death, or an SRE, a Serious Event Management Team (SEMT) is formed.
- If the event is low harm but repeating, investigation may be necessary.
- Investigations are also recommended for near misses with significant learning opportunities.
Safety Event Management System
- Safety events are reported and managed through a dedicated system.
- The system has a workflow process that guides event management.
Event Classification
- Events are categorized based on the level of harm.
- Categorization can occur before or after investigation depending on the hospital's reporting practices.
- PSMs utilize expertise and consult with the review team to determine the correct classification of the event.
Investigation Process
- Investigation aims to understand what happened, why it happened, and what lessons can be learned.
- Initial investigation involves gathering facts and data, including the patient's file and interviews with staff.
- Consultation with colleagues and experts is also a part of the process.
Serious Event Management Team (SEMT)
- SEMT reviews investigations for serious harm, death, or SREs.
- The team consists of the review team, medical practitioners, therapeutic support healthcare providers, and other individuals with relevant expertise.
- The SEMT's primary purpose is to identify contributing factors, establish root causes, and develop actions to prevent recurrence.
Reporting
- Various reports are generated for different types of events.
- These include After Action Review reports, provisional reports, final reports, and root cause reports.
- The content of each report is tailored to the specific event and investigation.
Timelines
- Safety events should be loaded and managed within a specific timeframe.
- The PSM may request additional time for events requiring special attention.
Alerts and Notifications
- The system automatically directs events through a workflow process.
- The PSM alerts unit managers for events requiring AAR completion.
- Notifications are sent to the hospital governance team once an event is closed.
- Alerts are sent for SREs and events with severe harm or death.
- Hospitals establish alert distribution email groups to ensure timely communication.
Actions Following Events
- Actions to address safety events are documented in reports.
- Unit managers ensure action completion by unit staff.
- The SMART principles are used to guide action development.
- The PSM collaborates with unit managers to identify continuous improvement opportunities.
- Improvement initiatives are driven by unit managers with expert input from the PSM, IPC manager, and pharmacists.
- The DMAIC methodology (Define, Measure, Analyze, Improve, and Control) is employed for continuous improvement initiatives.
Never Events
- Never events are severe, unambiguous, and preventable.
- These occurrences are managed with additional resources and an emphasis on learning.
- The Regional Clinical Manager (RCM), Operations Executive (OE), and corporate office individuals are notified within 48 hours of the event.
- A SEMT final team review meeting is scheduled within 2 weeks of the event.
Maternal and Neonatal Deaths
- All maternal deaths are reported on the Safety Event Management System.
- Investigations are conducted per the SRE process.
- Maternal deaths are reviewed by the National Committee for Confidential Enquiry into Maternal Deaths (NCCEMD).
- Neonatal mortalities and severe harm are investigated and reported.
- Specific events requiring reporting are outlined.
Healthcare-Associated Infections (HAIs)
- HAIs are managed by the Infection Prevention Control Manager (IPCM).
- All suspected or confirmed infections are reported using the N0983 Notification: Potential Infection form.
- The IPCM and the unit manager investigate HAIs.
- The IPCM documents findings on the IPC surveillance system (ICNet).
- The IPCM and the PSM may coordinate their efforts to address HAI events.
Serious Reportable Events (SREs)
- Certain events are classified as SREs based on type or level of harm (severe harm or death, including never events).
- SREs warrant additional resources and a comprehensive response due to their significant potential impact.
- The total number of SREs includes Process 1 events (specific types), Process 2 events (severe harm and death), and never events.
Patient Safety Event Management Policy
- This policy intends to define and manage patient safety events.
Policy Scope
- The policy applies to all patient safety events in the Mediclinic International group.
- Incidents that occur without a direct impact on patient safety, but relate to other concerns, are classified as non-safety events.
Definitions
- Patient safety events are clinical treatment occurrences that have led to patient harm.
- Never events are patient safety incidents that are largely preventable through the implementation of known and available guidelines or safety recommendations.
Never Event Categories
- Surgical/invasive procedure: This category includes any surgical procedure, whether in theatre or not.
- Medication: This category includes medication errors, such as mis-selection of a strong potassium solution, administration by the wrong route, etc.
- Mental health: This category includes failures in the physical environment, such as the absence of functional collapsible shower or curtain rails.
- General: This category includes other events, such as falls from poorly restricted windows.
Never Event Examples - Surgical/invasive procedures
- Wrong patient invasive procedure or surgery: This includes invasive interventions performed outside a surgical environment (e.g., nerve block, biopsy, etc.) or in a surgical environment (e.g., caesarean section, etc.).
- Wrong site or side invasive procedure or surgery: This includes any invasive procedure performed at the wrong site or side of the patient.
- Wrong surgery or invasive procedure performed: This includes any invasive procedure which is not consistent with the correctly documented informed consent and booking for that patient.
- Wrong implant or prosthesis: This includes the placement of an implant different from that specified in the procedural plan.
- Unintended retained foreign body after surgery or invasive procedure: This includes any foreign object unintentionally retained in a patient after surgery.
Never Event Examples - Medication
- Mis-selection of a strong potassium solution: This refers to administering strong potassium solution intravenously instead of the intended medication.
- Administration of medication by the wrong route: This refers to intravenous chemotherapy administered by the intrathecal route instead of the intended route.
Never Events - Patient Safety
- Never events are serious, preventable patient safety incidents that should never occur.
- A patient falls from a window that is "within reach" and is accessible without needing to move furniture or climb.
- A patient's chest or neck becomes entrapped between bedrails or in the bedframe/mattress if the bedrail dimensions or the combined dimensions do not meet required guidelines.
- A patient receives ABO-incompatible blood components or organs unintentionally.
- An unintentional ABO-mismatched solid organ transplant occurs. This excludes situations where the transplant is deliberate and clinically appropriate.
- A naso- or oro-gastric tube is misplaced in the pleura or respiratory tract before feeding, flushing, or medication administration.
- A patient is scalded by water used for washing or bathing (excludes scalds from water used for other purposes).
- A patient requiring oxygen is unintentionally connected to an air flowmeter. This excludes unintentional connection to an air cylinder instead of an oxygen cylinder because there are no barriers to prevent this.
- A patient's behavior, including aggression towards staff, visitors, other patients, or self-harm, is inappropriate due to self-harm, suicide, or missing patient situations.
- Patient monitoring occurs during and post-transfusion, potentially leading to a transfusion reaction that should be reported to the South African National Blood Service (SANBS).
- Radiology, infection prevention, and hand hygiene are also monitored, with reporting required for unavailability of water or handwashing supplies.
- Medical device events, including equipment failure, implantable devices, labeling issues, malfunction, or contaminated supplies, need to be reported to the South African Health Products Regulatory Authority (SAHPRA).
- The proper dispensing, labeling, procurement, and storage of medical gases and oxygen are monitored to report contaminated products or improper labeling to SAHPRA.
- Medication, biologics, fluids, and their preparation, dispensing, and delivery procedures require monitoring, with reporting for expired constituents, damaged or contaminated product, or mislabeled products, to SAHPRA.
- Perinatal events with maternal deaths require reporting to the National Department of Health (NDOH).
- Peri-operative events, including death, retained foreign objects, and incorrect surgical procedures require reporting to the Office of Health Standards Compliance (OHSC).
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