Patient Safety Management in Mediclinic
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Questions and Answers

What is the purpose of the patient safety event management policy?

  • To document and share standardized patient safety definitions and processes. (correct)
  • To create a database of all patient incidents.
  • To eliminate all patient safety events.
  • To solely provide legal advice to healthcare workers.

    • Which of the following is NOT included in the policy for patient safety event management?

  • An algorithm for ascertaining the type and level of harm.
  • Action points for minimizing financial losses from safety events. (correct)
  • Establishment of event ‘alert’ email groups.
  • Documentation of processes for investigation and escalation.

    • What is meant by 'Serious Reportable Events' as per the policy?

  • Events that have been reported multiple times.
  • Events that are predominantly related to paperwork errors.
  • Events including never events that result in severe harm or death. (correct)
  • Events that require immediate public notification.

    • What action should be taken following a safety event involving severe harm or death?

    <p>The Legal Department should be consulted for further management.</p> Signup and view all the answers

    What role do Continuous Improvement activities play in the patient safety event management policy?

    <p>They aim to improve patient safety and prevent harm based on analysis outcomes.</p> Signup and view all the answers

    Who is responsible for investigating adverse events according to the policy?

    <p>Corporate and hospital teams working together.</p> Signup and view all the answers

    How does the policy suggest sharing findings from safety event investigations?

    <p>By sharing findings at the hospital level to prevent recurrence.</p> Signup and view all the answers

    What should be done for matters involving maternal and neonatal deaths as per the policy?

    <p>They should follow established policy actions specifically outlined.</p> Signup and view all the answers

    What is the primary focus of the term 'Continuous Improvement' in healthcare?

    <p>Ongoing enhancement of products, services, or processes</p> Signup and view all the answers

    Which acronym refers to the systematic approach to solving problems that includes Define, Measure, Analyse, Improve, and Control?

    <p>DMAIC</p> Signup and view all the answers

    What defines a 'Never Event' in healthcare?

    <p>A patient safety incident that is largely preventable</p> Signup and view all the answers

    What does the acronym HAI stand for?

    <p>Healthcare-associated infections</p> Signup and view all the answers

    Which of the following is an example of an Invasive Procedure?

    <p>Teeth extraction</p> Signup and view all the answers

    What is the role of an IPM (Infection Prevention Control Manager)?

    <p>Coordinate infection prevention strategies</p> Signup and view all the answers

    What does the term 'Near Miss' refer to?

    <p>An event that did not reach the patient</p> Signup and view all the answers

    Which of the following best describes 'Patient Safety Culture'?

    <p>An environment promoting respect and learning from errors</p> Signup and view all the answers

    What is the purpose of the Safety Event Management System called TPSC?

    <p>To centralize reporting of safety-related events</p> Signup and view all the answers

    Which term is best defined as 'any source of potential damage or harm'?

    <p>Hazard</p> Signup and view all the answers

    Which role focuses on assessing and improving the safety of patient care directly?

    <p>Patient Safety Manager</p> Signup and view all the answers

    What is the effect of a 'Serious Reportable Event'?

    <p>Significant harm or death consequences</p> Signup and view all the answers

    What is meant by the term 'Adverse Event'?

    <p>An event resulting in unintended harm due to healthcare actions</p> Signup and view all the answers

    What role does an OHSC (Office of Health Standards Compliance) play?

    <p>Ensure compliance with health standards</p> Signup and view all the answers

    What must the Reporter include to receive feedback on the reported event?

    <p>Their email address</p> Signup and view all the answers

    During the After Action Review (AAR), which of the following questions focuses on learning from the event?

    <p>What can we learn from this?</p> Signup and view all the answers

    Which of the following is NOT a requirement for reporting an event?

    <p>Names of staff must be included</p> Signup and view all the answers

    What types of events must have all AAR questions completed?

    <p>Serious harm or death events</p> Signup and view all the answers

    What is the primary purpose of the First Team Review?

    <p>To ensure Just Culture principles are followed</p> Signup and view all the answers

    Which of the following describes the actions taken by the Unit/Line Manager after reporting an event?

    <p>Conducting an Initial Review and arranging a feedback session</p> Signup and view all the answers

    What framework helps identify contributing factors during event analysis?

    <p>Yorkshire contributing factors framework</p> Signup and view all the answers

    When should legal support be sought after an event occurs?

    <p>When there is harm to a patient or visitor</p> Signup and view all the answers

    Which of the following events might require further investigation?

    <p>Near misses with significant learning opportunities</p> Signup and view all the answers

    What is a responsibility of the Unit/Line Manager during the Initial Review of an event?

    <p>To ensure correctness and completeness of the report</p> Signup and view all the answers

    How should events with serious harm or death be documented in the Safety Event Management System?

    <p>All questions of the AAR must be completed</p> Signup and view all the answers

    Which statement reflects the approach of Just Culture in event management?

    <p>Encourage open communication without fear of blame</p> Signup and view all the answers

    What should be done if an event's report contains missing details?

    <p>Add missing details in the AAR questions</p> Signup and view all the answers

    What is the primary focus of a systems analysis in the context of patient safety events?

    <p>To analyze the interactions within the system</p> Signup and view all the answers

    What must occur if there are contributing factors identified during the AAR?

    <p>Document them as per the Yorkshire Contributing Factors Framework</p> Signup and view all the answers

    Which of the following events is classified as a Serious Reportable Event (SRE)?

    <p>A severe allergic reaction requiring emergency intervention</p> Signup and view all the answers

    What constitutes a Near Miss in safety event classification?

    <p>An event that did not reach the patient at all</p> Signup and view all the answers

    During the Step 1 of safety event management, what is essential for the healthcare worker (HCW) to do first?

    <p>Notify their line manager immediately</p> Signup and view all the answers

    Which step comes after reporting the event in the safety management process?

    <p>Initial Review and After-Action Review</p> Signup and view all the answers

    What is the expected maximum duration of mild harm classed as Low Harm?

    <p>Short/Medium term, resolved in a few hours</p> Signup and view all the answers

    For which type of incidents is a Serious Event Management Team primarily responsible?

    <p>Adverse events with severe outcomes</p> Signup and view all the answers

    What type of event is categorized as having No Harm?

    <p>An incident that reached the patient but had no detectable symptoms</p> Signup and view all the answers

    Which of the following actions is NOT recommended after a safety event causes harm to a patient?

    <p>Investigate the incident before notifying the patient</p> Signup and view all the answers

    Which classification denotes severe harm that may be permanent?

    <p>Severe Harm</p> Signup and view all the answers

    What action should the healthcare worker take after completing the event report?

    <p>Ensure the event documentation is short and concise</p> Signup and view all the answers

    What is one key characteristic of the Serious Reportable Events (SREs)?

    <p>They must be reported to a regulatory authority</p> Signup and view all the answers

    Which of the following describes the function of the Safety Event Management System?

    <p>To classify safety events automatically</p> Signup and view all the answers

    What is expected to be the outcome of the final team review in the event management process?

    <p>Feedback to the reporter on the event</p> Signup and view all the answers

    What must occur during the final review of a safety event?

    <p>The Serious Event Management Team must decide on further investigation or closure.</p> Signup and view all the answers

    Which report is preferred for documenting serious harm and death events?

    <p>Root Cause report</p> Signup and view all the answers

    What is essential for actions preventing future harm events?

    <p>Responsible individuals must be clearly assigned.</p> Signup and view all the answers

    When must all safety events be loaded and managed to closure?

    <p>By the 7th of the following month.</p> Signup and view all the answers

    Who should obtain guidance from the Legal Department?

    <p>Any staff member providing feedback to patients and families.</p> Signup and view all the answers

    What triggers the sending of alerts within the Safety Event Management System?

    <p>Events categorized by the PSM.</p> Signup and view all the answers

    What type of report compiles outcomes of investigations and identifies contributing factors?

    <p>ISBAR or Root Cause Analysis report</p> Signup and view all the answers

    What is the role of the Unit Manager in the management of safety events?

    <p>Ensure actions resulting from events are completed.</p> Signup and view all the answers

    Who is responsible for maintaining the alert distribution email group?

    <p>The PSM or designated manager.</p> Signup and view all the answers

    What information must be recorded in the CURA risk register?

    <p>The findings from the Risk Assessment Scale.</p> Signup and view all the answers

    How is the Provisional report characterized?

    <p>For all SREs and serious harm events, completed at First Team Review.</p> Signup and view all the answers

    What action should be taken if an event requires additional time for investigation?

    <p>The PSM may request additional time from the RCM.</p> Signup and view all the answers

    What is typically included in the feedback provided to staff and patients following an event review?

    <p>Comprehensive analysis of the event outcomes.</p> Signup and view all the answers

    What does the acronym SMART stand for in the context of developing actions for safety events?

    <p>Specific, Measurable, Achievable, Realistic, Time-based</p> Signup and view all the answers

    In the DMAIC methodology, which step focuses on measuring the performance and understanding the problem before improvement?

    <p>Measure</p> Signup and view all the answers

    Which actions are required within 48 hours of reporting a Never Event?

    <p>Email the event report to the Regional Clinical Manager and corporate office contacts</p> Signup and view all the answers

    What type of maternal death is classified as a death resulting from pregnancy complications?

    <p>Direct maternal death</p> Signup and view all the answers

    What is required after investigating a maternal death in Namibia in addition to reporting it on the Safety Event Management System?

    <p>An exhaustive investigation as per the SRE process</p> Signup and view all the answers

    Which neonatal event does NOT need to be reported according to the guidelines?

    <p>Death of a baby with a known congenital abnormality</p> Signup and view all the answers

    Who is primarily responsible for managing healthcare-associated infections?

    <p>Infection Prevention Control Manager</p> Signup and view all the answers

    What is true regarding the final report after discussing a Never Event?

    <p>It should be completed prior to the SEMT final team meeting</p> Signup and view all the answers

    What is a key responsibility of Unit Managers in the continuous improvement process?

    <p>Driving improvement initiatives and supporting healthcare workers</p> Signup and view all the answers

    What categorizes an accidental maternal death?

    <p>Death occurring due to unrelated incidents such as accidents</p> Signup and view all the answers

    What is a requirement when reporting neonatal mortalities?

    <p>Full investigations must be completed for specific categories of deaths</p> Signup and view all the answers

    When must improvement initiatives be driven according to the document?

    <p>Regularly, supported by the Unit Manager</p> Signup and view all the answers

    What must happen at the Mother and Baby Collaborative Meeting regarding maternal deaths?

    <p>All maternal deaths should be discussed for reviews and improvements</p> Signup and view all the answers

    How often should the status of actions regarding safety events be tracked?

    <p>Monthly</p> Signup and view all the answers

    Who is primarily responsible for leading the investigation of Healthcare-Associated Infections (HAIs)?

    <p>The Infection Prevention and Control Manager (IPCM)</p> Signup and view all the answers

    What must the Unit Manager do to support the IPCM during HAI investigations?

    <p>Actively participate and collaborate in the investigation</p> Signup and view all the answers

    What type of events are classified as Serious Reportable Events (SREs)?

    <p>Events that are unambiguous and preventable with significant impact</p> Signup and view all the answers

    Which of the following is considered a behaviour event in the context of patient safety?

    <p>Physical contact resulting in actual assault</p> Signup and view all the answers

    What is the consequence of an event involving the incorrect administration of a blood product?

    <p>It could lead to severe harm or death</p> Signup and view all the answers

    Which statement reflects proper practice for managing a missing patient situation?

    <p>Always report the incident and initiate appropriate protocols</p> Signup and view all the answers

    What is a key responsibility of the IPCM in the context of infection prevention and control?

    <p>Document investigation findings in the IPC surveillance system</p> Signup and view all the answers

    Which of the following is NOT classified as a type of serious reportable event?

    <p>Minor allergies related to medication administration</p> Signup and view all the answers

    Which event directly relates to the unauthorized use of a patient’s medical information?

    <p>Bogus professionals providing care</p> Signup and view all the answers

    What constitutes a never event?

    <p>An unambiguous event that is preventable and leads to serious outcomes</p> Signup and view all the answers

    What aspect of care should always be monitored during and post a blood transfusion?

    <p>Adverse reactions including symptoms of hemolysis</p> Signup and view all the answers

    What is the primary goal of applying interventions after an HAI investigation?

    <p>To ensure similar events do not recur in the future</p> Signup and view all the answers

    Which of the following situations would be classified as a medical device event?

    <p>Use of implanted devices resulting in their removal</p> Signup and view all the answers

    What should be included in the total count of Serious Reportable Events (SRE)?

    <p>Events of severe harm and death, as well as never events</p> Signup and view all the answers

    Which of the following best describes a perinatal event?

    <p>Maternal death or severe injury related to childbirth</p> Signup and view all the answers

    What is categorized as a Never Event within surgical procedures?

    <p>Incorrect surgical site</p> Signup and view all the answers

    Which situation is considered a physiological complication not present prior to surgery?

    <p>Air embolus</p> Signup and view all the answers

    Which of the following is NOT a factor to be reported during anesthesia care?

    <p>Insufficient monitoring of vitals</p> Signup and view all the answers

    What type of injury is classified as hospital-acquired and involves deterioration?

    <p>Stage 4 pressure injury</p> Signup and view all the answers

    What action should be taken when an event involving expired medication occurs?

    <p>Send the medication to the pharmacy properly marked</p> Signup and view all the answers

    What constitutes a breach of confidentiality in patient safety event management?

    <p>Unauthorized access to medical records</p> Signup and view all the answers

    What should be done after an occupational injury has been reported?

    <p>Complete an AAR and contributing factors</p> Signup and view all the answers

    Which of the following is considered a non-safety event?

    <p>Medication expiration</p> Signup and view all the answers

    Which situation is defined as a Never Event related to medication?

    <p>Expired medication administered</p> Signup and view all the answers

    What should be done if a patient is sent home with the wrong parents?

    <p>Report it as a patient safety event</p> Signup and view all the answers

    What is required when an event of an iatrogenic pneumothorax occurs?

    <p>Investigation and documentation of the event</p> Signup and view all the answers

    What characterizes an operating room fire as a never event?

    <p>It can lead to severe patient injuries</p> Signup and view all the answers

    What is a key requirement for an event to be categorized as a Never Event?

    <p>Evidence of previous occurrence must exist</p> Signup and view all the answers

    What condition must be met to classify pressure injuries that were present on admission?

    <p>They can be Stage 3, Stage 4, or unstageable</p> Signup and view all the answers

    What is the primary role of the PSM in the event classification process?

    <p>To determine the correct classification of the event</p> Signup and view all the answers

    Within what timeframe must the PSM review and classify the event after it has been reported?

    <p>5 working days</p> Signup and view all the answers

    What must happen if the event results in serious harm or death?

    <p>An initial report using the ISBAR format should be completed.</p> Signup and view all the answers

    What is a Multi-Event as described in the classification principles?

    <p>When multiple individuals experience harm from similar causes</p> Signup and view all the answers

    What is the purpose of the Serious Event Management Team (SEMT)?

    <p>To conduct reviews and provide recommendations for serious harm or death events</p> Signup and view all the answers

    Who is responsible for scheduling a meeting with the healthcare workers involved in the event?

    <p>The PSM in consultation with the Unit Manager</p> Signup and view all the answers

    What should be included in the preliminary investigation conducted by the PSM?

    <p>Gathering initial facts, relevant policies, and previously reported similar events</p> Signup and view all the answers

    What must be documented in the Event Management System after SEMT actions are planned?

    <p>Individual actions with due dates and responsible individuals</p> Signup and view all the answers

    If agency staff members are involved in an event, what is their required action?

    <p>They should complete the electronic Safety Event Report and submit it to their agency.</p> Signup and view all the answers

    What should be identified during the collation of information step?

    <p>Contributory factors and potential learning gained from the event</p> Signup and view all the answers

    Which document layout is required for initial reports about serious harm events?

    <p>ISBAR layout</p> Signup and view all the answers

    What does the acronym ISBAR stand for in the reporting context?

    <p>Information, Situation, Background, Assessment, Recommendations</p> Signup and view all the answers

    Which role is NOT included in the SEMT?

    <p>Patient safety officer</p> Signup and view all the answers

    What must the PSM consult with when determining the appropriate harm level?

    <p>Unit Manager and HCWs involved</p> Signup and view all the answers

    What is a potential consequence of unintentional connection to an air flowmeter for a patient requiring oxygen?

    <p>Inadequate oxygen delivery</p> Signup and view all the answers

    What is excluded from the patient safety events regarding unintentional connections?

    <p>Connection to an air cylinder</p> Signup and view all the answers

    Which level of patient behavior requires reporting to the OHSC involving physical contact towards staff?

    <p>Physical assault</p> Signup and view all the answers

    In the context of medical gases, what does an illegible product label lead to?

    <p>Potential dispensing errors</p> Signup and view all the answers

    What type of incident would involve reporting to the SANBS?

    <p>Transfusion reaction</p> Signup and view all the answers

    What should be reported if there is a contamination of a medical product?

    <p>Procurement/supplier processes</p> Signup and view all the answers

    Which of the following is categorized as a Level 1 patient safety event?

    <p>Missing minor patients</p> Signup and view all the answers

    Which level of behavior includes sexual assault by a visitor towards a patient?

    <p>Level 3</p> Signup and view all the answers

    What is the adequate action for an incorrect surgical procedure performed on a patient?

    <p>Report to OHSC</p> Signup and view all the answers

    In case of an adverse drug reaction during patient monitoring, who should the issue be reported to?

    <p>SAHPRA</p> Signup and view all the answers

    What constitutes an unintended retained foreign body after a surgical procedure?

    <p>Any item that was subject to a formal counting process but remains in the patient after closure</p> Signup and view all the answers

    Which of the following scenarios qualifies as a Never Event regarding medication administration?

    <p>A patient is given oral medication via intravenous route</p> Signup and view all the answers

    Which of the following procedures is not classified as a surgical/invasive procedure?

    <p>Blood transfusion</p> Signup and view all the answers

    What is a key factor regarding falls from poorly restricted windows in healthcare settings?

    <p>Windows accessible to patients which can be opened easily</p> Signup and view all the answers

    What best describes the handling of mismatched organ transplants under the policy?

    <p>Unintentional ABO-mismatched organ transplantation is categorized as a Never Event</p> Signup and view all the answers

    What defines the start of surgery?

    <p>The first incision into the skin</p> Signup and view all the answers

    What condition leads to chest or neck entrapment in bed rails?

    <p>Use of adjustable bedrail heights that do not meet guidelines</p> Signup and view all the answers

    Which scenario would constitute a 'wrong patient' invasive procedure?

    <p>Performing a lumbar puncture on the wrong patient</p> Signup and view all the answers

    Which situation can lead to a patient being scalded by water?

    <p>Water used during a washing process is excessively hot</p> Signup and view all the answers

    What is an example of a situation that would not be classified as a wrong site or side procedure?

    <p>Removing the wrong tooth during dental surgery</p> Signup and view all the answers

    Which action must be taken to ensure the correct implant/prosthesis is used?

    <p>A check with the surgeon and surgical representative prior to implantation</p> Signup and view all the answers

    Which of the following describes the mis-selection of a potassium solution?

    <p>A diluted potassium solution is mistakenly administered</p> Signup and view all the answers

    What is significant about the installation of collapsible shower or curtain rails?

    <p>They are designed to collapse during a patient fall</p> Signup and view all the answers

    What is a correct definition of a wrong surgery or invasive procedure?

    <p>A procedure performed that is inconsistent with the patient’s informed consent</p> Signup and view all the answers

    Which example is excluded from the definition of a wrong patient invasive procedure?

    <p>Peripheral IV insertion on a wrong patient</p> Signup and view all the answers

    What defines a misplaced naso- or oro-gastric tube?

    <p>When it enters the respiratory tract without prior detection</p> Signup and view all the answers

    What should be recorded if unknown/unexpected anatomical abnormalities are discovered?

    <p>Documentation in the patient's notes</p> Signup and view all the answers

    When should actions to locate retained foreign objects be recorded in the patient notes?

    <p>When the items are known to be missing post-procedure</p> Signup and view all the answers

    What best describes 'never events' in surgical procedures?

    <p>Serious incidents that arise due to human error</p> Signup and view all the answers

    What aspect of bedrail design may contribute to a patient’s entrapment?

    <p>Dimensions that do not align with regulatory guidelines for safety</p> Signup and view all the answers

    What issue arises from incorrect preprocedural measurements?

    <p>Inaccurate information that may result in incorrect implant usage</p> Signup and view all the answers

    Which procedure would fall under the category of wrong site or side invasive procedures?

    <p>Surgery on the opposite limb than consented</p> Signup and view all the answers

    Which factor is not a consideration before a surgical procedure?

    <p>Determining if the surgeon is experienced</p> Signup and view all the answers

    What can lead to the incorrect administration of IV medication?

    <p>Not adhering to the prescribed route of administration</p> Signup and view all the answers

    In the case of incomplete surgical procedures, why may one of the procedures not be performed?

    <p>Due to the failure to perform safety checks</p> Signup and view all the answers

    Which of the following scenarios illustrates the concept of wrong implant or prosthesis?

    <p>Inserting an intrauterine contraceptive device that differs from the patient's consented choice</p> Signup and view all the answers

    What is a crucial responsibility of the surgeon during an invasive procedure?

    <p>To be accountable for the surgical outcome</p> Signup and view all the answers

    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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