Patient Safety Event Management Policy (Mediclinic Southern Africa) PDF

PATIENT SAFETY EVENT MANAGEMENT POLICY MCSA C.8.3 Purpose The purpose of this policy is to document and share standardised patient safety definitions and processes pertaining to the identification, reporting, investigation, escalation, and improvement following safety events relating to patients, f...

PATIENT SAFETY EVENT MANAGEMENT POLICY MCSA C.8.3 Purpose The purpose of this policy is to document and share standardised patient safety definitions and processes pertaining to the identification, reporting, investigation, escalation, and improvement following safety events relating to patients, families as well as healthcare workers. It is based on the Mediclinic Group Framework for Event Management published in March 2023. The policy includes:  New definitions pertaining to events including an algorithm to ascertain the type of Event, level of harm and the Serious Reportable Events (including never events)  An outline of role-players and their responsibilities  Documentation of the processes to be followed for reporting, investigation and Notification/escalation following safety events  Actions to take following a safety event with severe harm or death or a Serious Reportable Event  Establishment of event ‘alert’ email groups and escalation flows with specific Timeframes for completion of safety event reports and investigations  The expectation that the outcomes of analysis should lead to Continuous Improvement activities, designed by corporate and hospital teams, aimed at improving Patient Safety and preventing harm  Processes to be followed in reporting a matter to the Legal Department and describes the further interaction with and functions of the Legal Department  In addition to the policy actions to be taken in Maternal and neonatal deaths Applicability The policy is applicable to all Mediclinic Southern Africa staff, all healthcare practitioners and non-Mediclinic personnel rendering services in Mediclinic facilities. It requires a collaborative approach between nursing staff and doctors directly involved in patient care, pharmacists and patient safety managers, unit and line management, support service staff and all other healthcare workers. Policy statement Mediclinic Southern Africa (MCSA) views the safety and wellbeing of patients, employees, other health care workers, visitors and contractors as a priority. If any of these individuals have been harmed (an adverse event), or almost harmed (a near miss) during hospitalisation or on our premises, the events leading up to this must be investigated. Findings must be shared and Patient Safety Event Management Policy MCSA C.8.3 Page 1 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. action taken at hospital level to prevent a recurrence of similar events. From these learnings, systemic improvement initiatives should be developed and spread throughout the company using contemporary Continuous Improvement science principles. In addition, in respect of matters where there have been harm or potential harm to a patient and/or visitor, the Legal Department must be consulted to advice on the further management thereof. Acronyms Acronym Description DMAIC Define, Measure, Analyse, 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 Compliance1 PSM Patient Safety Manager PxM Patient Experience Manager RCA Root Cause Analysis RCM Regional Clinical Manager SAHPRA South Africa Health Products Regulatory Agency SEMT Serious Event Management Team SRE Serious Reportable Event ‘The Patient Safety Company’ is the name of the safety event reporting TPSC system UM Unit Manager 1 South Africa only Patient Safety Event Management Policy MCSA C.8.3 Page 2 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Definitions Definitions as they appear in the policy are provided below. Please refer to the Patient Safety Event Terminology Guideline for more detailed definitions of different events. Term Definition Adverse Event An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient. Clinical Risks Clinical risk means the likelihood that an Adverse Incident will cause injury or harm to the patient Continuous It is the ongoing improvement of products, services or processes Improvement through incremental and breakthrough improvements. It is a systematic, sustainable approach to enhancing the quality of care and outcomes for patients. In MCSA we use a variety of methodologies to solve problems in the workplace. Some of the simple and easy-to-understand methodologies that are used for structured problem solving include: PDSA (Plan, Do, Study, Act) cycle, DMAIC (Define, Measure, Analyse, Improve, Control) and A3 problem solving. Harm Any physical or psychological injury or damage to the health of a person, including both temporary and permanent injury. Hazard Hazard means any source of potential damage, harm, adverse health effects on patients or healthcare personnel or any threat to their safety Invasive Procedure This includes interventions that are surgical but may be done outside a surgical environment – for example, blocks for pain relief, biopsy, interventional radiology procedure, cardiology procedure, drain insertion and line insertion (e.g. peripherally inserted central catheter (PICC)/ Hickman lines). This also includes teeth extractions. Invasive Procedure The start of an invasive procedure is when a patient’s anatomy start time begins to be permanently altered. For example, this is when the first incision is made that will scar the patient and take time to heal and recover from regardless of the setting, at the point of surgical incision, tissue puncture, or the insertion of an instrument into tissues, cavities, or organs. Near Miss Event which DID NOT reach the patient, either through luck or early detection. Patient Safety Event Management Policy MCSA C.8.3 Page 3 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Never Events Never Events are part of the Serious Reportable Events category. Never Events are patient safety incidents that are largely preventable through the implementation of known and available guidelines or safety recommendations that provide strong systemic protective barriers, and which have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened because of a specific incident for that incident to be categorised as a Never Event. For each Never Event type, there is evidence that the Never Event has occurred in the past – for example, through previous reports and that the risk of recurrence remains. Never Events can occur in various settings within healthcare and are grouped into: Surgical/invasive procedure, Medication, Mental Health and General. Definitions are provided in Annexure C – Dec 2022 Non Safety Events These are events that occur without a direct impact on a patient. They may point to other concerns such as occupational risks or hazards. Events include for example equipment breakages, medication breakages/expiration, financial statement errors, infrastructure damage or hazards. Patient Safety “Patient Safety is defined as the prevention and mitigation of harm caused by errors of omission or commission associated with healthcare and involves the establishment of systems and processes that minimise the likelihood of errors and maximise the likelihood of intercepting them when they occur (Angood et al., 2009).” Patient Safety Culture A Patient Safety Culture is defined as a “collaborative environment in which skilled clinicians treat each other with respect, leaders drive effective teamwork and promote psychological safety, teams learn from errors and near misses, caregivers are aware of the inherent limitations of human performance in complex systems (stress recognition) and there is a visible process of learning and driving improvement through debriefings”. Group framework March 2023 Psychological Safety “A shared belief held by members of a team that the team is safe for interpersonal risk taking. It’s about giving candid feedback, openly admitting mistakes, being willing to ask for help and learning from each other.” Group framework March 2023 Safety Event An unanticipated, undesirable, or potentially dangerous occurrence in a healthcare organisation. Safety event The Safety event management system software is called The management system Patient Safety Company or TPSC. It is a central reporting system in which safety-related near misses and events are captured for review, risk rating and future continuous improvement monitoring Patient Safety Event Management Policy MCSA C.8.3 Page 4 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Serious Reportable Events that have serious harm or death consequences to patients Events and families, staff or the organisation and that warrant a comprehensive response and the use of additional resources to ensure appropriate action and learning take place. These include never events. Update as per Annexure A Dec 2022 Systems analysis A Systems analysis looks at the many factors that contributed to a Patient Safety Event. “A system analysis yields an understanding of how a system works and how different elements in a system interact. Adopting a systems approach to harm reduction requires a shift from blaming individuals for errors to analysing systems to uncover design flaws, thus moving from addressing problems reactively (i.e. after problems occurred) to proactively preventing accidents through system analysis and design.” Roles and responsibilities Person/Role Responsibilities Patient Safety  Facilitates and improves systems thinking about patient Manager (or safety by ensuring that events are identified, reported, equivalent or stand- correctly classified, and investigated using a systems in) (PSM) analysis, in accordance with this policy.  Supports Unit/Line Managers in the investigation of events with high levels of harm and actively participate in capacitation/mentoring support for these managers pertaining to the use of improvement science to prevent harm.  By fulfilling this role, the PSM is responsible for creating a patient safety culture in the hospital. Nurse practitioners  Identify and report any patient safety events to their direct line manager.  After assessing and recovering the patient the nurse must complete an electronic Event Report (on the safety event management system) reflecting as accurately as possible the circumstances surrounding the event.  Participate in investigations of these events and the development of actions and ensure that chosen action plans are implemented according to their responsibilities. Patient Experience  Identifies complaints that may have been a safety event and Manager (PxM) alerts the Unit/Line Manager verbally to facilitate appropriate management by the Unit/line Manager.  The PxM must be part of the investigation or review of all events which require a liaison person, events may differ in severity.  The PxM is notified of and consulted for advice, together with the Legal Department, where required, if there is risk of significant reputational damage from an event occurring, and supports the hospital staff and/or Patient Safety Manager in managing the feedback to the patient and family. Patient Safety Event Management Policy MCSA C.8.3 Page 5 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Person/Role Responsibilities Line/Unit Managers/  Ensure that all patient safety-related events are identified by encouraging patient safety awareness at unit/department level.  Oversee that patients are assessed for patient safety risks and mitigation actions are put in place.  Prevent further harm to a patient post the event, including ensuring that appropriate care plans and communication plans are in place.  Oversee that staff complete the electronic Safety Event Report accurately with sufficient detail, assist in the suitable categorisation of the event and ensure the event is loaded in the event reporting system in a timeous manner.  Perform the After Action Review to increase learning from events and capture the results thereof in the system.  Actively participate in the systems analysis investigations to ensure that chosen action plans are appropriate and implemented.  Where continuous improvement initiatives are developed, drive these initiatives either personally or by supporting his/her staff to implement the necessary improvements. Nursing  As clinical lead for the hospital: ensures that all patient safety- Management (NM, related events are identified, reported and that relevant action DNM) /Hospital plans are developed and implemented. Clinical Manager  Receive feedback on events reported from the Unit/Line (HCM) Managers.  Ensure that system analysis investigation of events is conducted where required with members of the hospital teams, participating where necessary and Continuous Improvement initiatives to address concerns are implemented and managed by the unit managers.  Engage with the medical practitioners involved in patient safety events and specifically Serious Reportable Events to address concerns and develop mutual improvement action plans. Clinical Performance  Reviews clinical outcome and patient safety event trends to Team (Corporate ascertain national collective priorities and updates the MCSA Office) clinical risk register.  Based on these trends, designs and deploys collective improvement collaborative initiatives.  Improve standardisation of patient safety processes and behaviours which includes the creation of a Patient Safety and Just Culture, an organisational structure and infrastructure to facilitate collective learning.  As functional lead, creates opportunity to capacitate PSMs in patient safety management practices, mentorship skills and continuous improvement. Patient Safety Event Management Policy MCSA C.8.3 Page 6 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Person/Role Responsibilities Regional Clinical  Oversees, acts and coaches on event reporting, investigation Manager (RCM) and documentation, and monitors trends and improvement actions of individual hospitals and the region.  Where required, engages Clinical Services Specialists at Corporate Office for expert advice and involves the Regional Operations Executive as needed in Serious Event Management Team Reviews.  Creates a safe and conducive environment for reporting of events and actively encourages continuous improvement collaborative initiatives. Hospital General  Monitors patient safety trends, manages the overall risks, and Manager (HGM) participates in investigations and analysis, and the Serious Event Management Teams.  Participates in the review of events as part of the Serious Event Management Team and involves the Regional Operations Executive as needed  Supports the Nursing Manager/Hospital Clinical Manager in engaging the medical practitioners to address Patient Safety and Serious Reportable Events. Infection Prevention  Provides expert support and guidance in the review and analysis & Control Manager of infection control indicators and healthcare-associated infection (IPCM) events and works with the PSM to identify and develop specific continuous improvement initiatives relating to these. Stands in for the PSM when on leave.  Leads the investigation of suspected or confirmed healthcare- associated infections in collaboration with the unit manager with development of suitable action plans. Medical and allied  Reports any patient safety-related events to a staff member or healthcare completes an event report him/herself on the safety event practitioner management system.  Participates in the systems analysis and design of improvement actions.  In the event of a Serious Reportable Event or serious harm event, participates in the investigation and assists the hospital staff to develop action plans to address patient safety concerns.  Acts as champion for patient safety in the hospital by encouraging safe practices. Patient Safety Event Management Policy MCSA C.8.3 Page 7 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Pharmacy Manager/  Identifies and reports any events and intervenes immediately Pharmacists where appropriate.  Notifies the medical practitioner, unit manager and PSM of any serious concerns related to medication.  Completes and loads a Safety Event Report on the safety event management system and/or pharmacy interventions module.  Reports adverse drug reactions to the South African Health Products Regulatory Authority (SAHPRA)) and shares common concerns at the Quality meetings of the hospital.  Participates in investigations of safety events where relevant and ensures that chosen action plans are implemented. Legal department  Assists hospitals (or a subsidiary, such as ER24) in managing patient safety events, complaints and legal enquiries as soon as they arise by guiding/advising/instructing hospital management regarding the most appropriate action to take in order to manage and minimize the legal, financial and reputational risks posed. Case Manager  Reports and codes any safety events on the patient’s file as part of the clinical history.  Safety events that will change the financial outcome of the claim must be coded and communicated to the funders and to the hospital Patient Administration Manager. Patient  Assists the PSM in the collection, copying and distribution of Administration health records for medico-legal investigations. Manager Technical Manager  Receives all equipment related safety and non-clinical events and investigates and reports these as required.  Reports equipment failure, as determined by the investigation to the equipment supplier/manufacturer, on the risk register and to the procurement division at the Corporate Office. General Manager  Receives and reviews reports of safety events that have a Clinical Services and significant impact on/by the medical practitioners and where Chief Clinical Officer action may be needed towards such medical practitioners. Occupational Health  Debriefing of staff involved in serious safety events to maintain staff/ Organisational psychological safety and psychological wellbeing. Effectiveness Doctor Relationship  DRMs can assist in gaining medical practitioners’ support and Manager (DRM) involvement in the safety event reporting, reviewing and investigation of Serious Reportable Events. Review Team  Review all events to determine completeness of reports, appropriateness of actions planned and taken, feedback to be provided to the patient and their family;  This team may already meet daily during handovers or be coordinated regularly to discuss all safety events that have occurred in the preceding period.  This is a small team consisting of: Unit Manager, PSM/IPCM, HCM, and Nursing Management. Patient Safety Event Management Policy MCSA C.8.3 Page 8 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Serious Event  Review all severe harm, deaths and Serious Reportable Events Management Team to determine completeness of reports, appropriateness of actions (SEMT) planned and taken, key contributing factors and root cause and ensure appropriate guidance is sought from legal before feedback is provided to the patient and their family;  Ensure implementation of actions or quality improvement initiatives to close the loop on serious harm events  These individuals include the Review Team plus additional members including:  Hospital General Manager  Night duty manager (if needed), PxM, Pharmacy manager or clinical/ward pharmacists  The Medical Practitioner or Allied Healthcare Practitioner  Any other relevant person, depending on the event  Regional and Corporate Office depending on the type of event - (Legal, Chief Clinical Officer, Clinical Performance Team, General Manager Clinical Services, Nursing Executive, Pharmacy Executive, Clinical Pharmacists, Nursing Quality Specialists) Governance Team  Receive and evaluate the reports on all safety events, ensure that actions have been implemented as described and follow up any actions which need to be completed;  This includes the most senior management of the hospital and should include the senior Medical Practitioners within the Clinical Performance Committee or the Clinical Hospital Committee or the Board.  In practice, this function to be fulfilled by CPC. Classification of safety events There are only 3 types of safety events: a. Near Miss b. Adverse Event c. Serious Reportable Event (SRE) – these include:  Events that were previously classified as Never Events plus other internationally accepted reportable events  Events that must be reported to a regulatory authority such as blood reactions (SANBS), drug reactions (SAPHRA) and early warning indicators (EWS) for the Office of Health Standards Compliance (OHSC).  See annexure B for details of the types of SREs. The Safety event management system automatically determines whether the event reported is a SRE. d. Non Safety Events: These are events that occur without a direct impact on the safety of a patient. They may point to other concerns such as occupational risks or hazards. Events include for example equipment breakages, medication breakages/expiration, financial statement errors, infrastructure damage or hazards. Patient Safety Event Management Policy MCSA C.8.3 Page 9 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. There are 5 levels of harm which will improve the ability of PSMs to classify safety event outcomes with more granularity. Table 1 describes the 5 levels of Harm. This denotes the harm caused to the patient at the time that the event is reviewed and must be based upon what is known at the time about the patient’s outcome. Near Miss Event which DID NOT reach the patient, either through luck or early detection. No Harm Event that did reach the patient but did not result in detectable harm, no treatment was required, no symptoms detected. Low Harm Impact – mild, full recovery expected Duration – short/medium term, resolved in a few hours, can be transient emotional distress Intervention – minimal or none, extra observation, minor treatment, or minor surgical intervention Moderate Impact – short term harm, full recovery expected, psychological Harm distress requiring counselling Duration – resolved in < 7 days, may increase length of stay Intervention – require medical (IV Fluids or antibiotics) /surgical treatment (return to theatre for a complication caused during primary procedure), cancellation of treatment, transfer for care Severe Harm Impact – unlikely to regain the level of previous independence Duration – > 7 days incapacity or chronic pain > 12 weeks, it can be permanent, it may shorten life-expectancy Intervention – prolonged hospitalisation, major surgery (e.g. colostomy), admission to higher level of care (ICU/ CCU/ High Care) Death Death was not reasonably expected as an outcome of healthcare by treating clinicians, care givers and patient and family. Death was caused or brought forward in the short term by the event, on the balance of probabilities Table 1: Level of harm classification Patient Safety Event Management Policy MCSA C.8.3 Page 10 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Overview of the management of safety events Step 1 Event identification and Reporter and Line By end of shift Immediate action (mitigate Manager Unit Level further harm) Reporter Step 2 Report Event on system ALERT 5 working Step 3 Line Manager days Initial Review and After- Action Review (AAR) Patient Safety 5 working days Step 4 Categorisation and ALERT 15 working days Provisional Reporting Review Team Facility/Hospital level Close event and provide Step 5 reporter with feedback First Review - determine Level of Investigation System analysis needed Step 6 Investigation Review Team or Close event and provide Serious Event Step 7 reporter with feedback Management Team Final team review and Report Final Report to Governance Teams Step 8 Emails to hospital distribution list for Improvement Actions and ALERT SREs Learning 1 Figure 1: Overview of the process of reporting and managing events (Timeframes Included) As described in the Mediclinic Group Framework for Event Management. Alerts are sent by the system for SRE events to the individuals set up within the hospitals distribution list on the Safety Event Management System. Management and reporting of safety events 1. Initial management and verbal reporting of a safety event (Step 1) 1.1. The HCW who identifies that a safety event has occurred must notify their line manager immediately, so that action can be taken to assess the patient and prevent further harm. 1.2. A clinical care plan must be developed thereafter to monitor the patient’s response to interventions to prevent further harm. 1.3. The patient’s treating doctor must be notified that a safety event has occurred so that any specific treatment or investigation can be prescribed. 1.4. Where an event has caused harm, the patient and/or their family must be notified that a safety event has occurred and that an investigation will follow. 1.5. The assistance of the PxM must be called upon to assist in providing feedback to the patient/visitor and/or their family that a safety event has occurred. 1.6. Legal advice/instruction must be obtained from the Legal Department as soon as practically possible following an event and prior to engaging with the patient/visitor and/or their family on the matter. 2. Reporting (Step 2) 2.1. The HCW (the Reporter) directly involved in the safety event or their immediate Supervisor (Shift leader/Unit Manager) documents what was observed during the event in the patient file. Patient Safety Event Management Policy MCSA C.8.3 Page 11 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  2.2. The Reporter completes the event as a Safety Event Report on the Safety Event Management System before the end of the shift. The form is short and simple and it requires the minimum information. 2.2.1. where the event occurred (unit/area) 2.2.2. when the event occurred 2.2.3. what happened 2.2.4. who is affected, and 2.2.5. a short narrative description describing the circumstances around the event. 2.3. No names of patient, staff or doctors should appear on the description of the event to always maintain confidentiality. If more than one person was involved the following convention should be used - Nurse X, or Nurse Y or Dr A or Dr B etc. should be used. 2.4. The Reporter should classify the event into the most suitable type of event as per their opinion. See Annexure C for types of events the reporter can classify. 2.5. Should the Reporter want to receive feedback on the event they should include their email address in the section where they complete their name on the Safety Event Management System. 2.6. All events can be reported anonymously but must contain a minimum of the patient’s information, hospital / business unit and unit in which it occurred. 3. Initial Review by Unit/Line Manager and After Action Review (AAR) (Step 3) 3.1. The Unit/Line Manager will conduct an Initial Review of the event once it has been reported to ensure completeness and correctness. 3.2. Thereafter, a feedback or debriefing session must be arranged by the Unit/Line Manager with all staff involved in the event and with the rest of the shift to perform an After Action Review (AAR). 3.3. This is an opportunity to review the actions taken in response to an event, identify gaps and lessons learnt and make staff aware of the patient safety event and harm caused to reinforce risk mitigation and prevention measures or compliance to standard policies and procedures. 3.4. Questions to answer in the After Action Review (AAR) include:  What was supposed to happen? (plan)  What happened? (Action)  What was the difference between the plan and the action? (review – bad or good)  What can we learn from this? (Personal and collective change)  What will you do in the future? 3.5. The Unit/Line Manager must document the following on the Safety Event Management System:  The AAR information - for No, Low and Moderate harm events only questions ‘iv’ and ‘v’ need to be completed.  For Serious harm or death events ALL questions MUST be completed. It is especially important to be clear about the actions to prevent harm in the future.  If there are any missing details from the event report these should be added into questions ‘ii’ of the AAR.  Describe what contributing factors (as per the Yorkshire contributing factors framework –were relevant at the time of the event. Patient Safety Event Management Policy MCSA C.8.3 Page 12 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. 4. First Team review (all events) (Step 5) 4.1. This step may occur before or after Step 4 depending on how the hospital reports events as part of their normal daily patient safety processes. 4.2. The Unit/Line Manager reports the safety event verbally to the “Review Team” (nursing management, PSM, IPCM, Night Manager and Hospital Clinical Manager) either immediately or at handover meetings or other similar meetings as determined by the hospital. 4.3. This “First Team Review” ensures that Just Culture principles are adhered to, determines the level of review, ensures that the action loop is closed, disseminates recommendations, and learning to continuously improve the event management process. 4.4. This “First Team Review” needs to evaluate whether: 4.4.1. The response and recovery efforts taken by the Unit/Line manager are appropriate, suitable and sufficient to prevent continued harm to the patient 4.4.2. Actions taken to prevent future harm to others is appropriate; 4.4.3. HCWs involved have been supported in terms of accessing psychological support through the Occupational Health provider and that Just Culture principles are adhered to where necessary. 4.4.4. Identify all the associated contributing factors as per the Yorkshire Contributing Factors Framework 4.5. Seek immediate Legal Support: 4.5.1. In all matters where there is harm or potential harm to a patient/visitor and feedback is to be provided to the patient/visitor and/or their family the advice/instruction of the Legal Department must be obtained. This is to ensure that MCSA’s legal, financial and reputational risks are protected. 4.5.2. It is thus critical to ensure that events (irrespective of the classification/level of harm) are timeously discussed with the Legal Department so that Legal advice/instruction must be obtained from the Legal Department telephonically as soon as practically possible following an event and prior to engaging with the patient/visitor and/or their family on the matter. 4.5.3. Ideally a telephone call to the Legal Department is made, which will ensure immediate assistance at the time of the event where possible. The Legal Department will provide guidance on what information is required further 4.5.4. Send an e-mail in outlook as soon as practical possible with the event reference number (unique AE-number as generated by the event management system) highlighting the concerns related to the event. The Legal Advisers can access the event in the event management system and follow the progress of the event. 4.5.5. Legal Advisers will continue to correspond with the PSM / dedicated manager on any legal matters related to the event and not on the event management system. 4.6. A decision is then made if the event requires further investigation:  If an event resulted in severe harm or death or is a SRE then a Serious Event Management Team (SEMT) must be established, see more detail in 5.6. Patient Safety Event Management Policy MCSA C.8.3 Page 13 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.   If the event is low harm but it is a repeating event in the unit then an investigation may be required to established common contributing factors and improvement opportunities.  If the event was a near miss and there are significant learning opportunities then it should also be investigated further to be used as a learning opportunity. 4.7. If further investigation is required then it moves into Categorisation (step 4) and then investigation phase step 6. 4.8. If no further investigation is needed the event can be asked to be closed by the Review Team and noted as such on the Safety Event Management System by the PSM once classification has occurred. 5. Categorisation of events (all events) (Step 4) 5.1. This step may occur before or after Step 5 depending on how the hospital reports events as part of their normal daily patient safety processes. 5.2. The PSM reviews the safety event report and the Type of Event as was selected by the reporter. 5.3. The PSM will utilise their expertise, in consultation with the Review Team, to determine the correct classification of the event to the most detailed level. Annexure D describes the new classification system to be utilised. 5.4. The level of harm as selected by the reporter must be reviewed and changed to the most appropriate harm level (Table 1). 5.5. This may require engagement with the Unit Manager or HCWs involved to get additional information about the event. 5.6. This needs to occur within 5 working days of the event being reported. 5.7. If the event is serious harm or resulted in death an initial report using the ISBAR layout should be completed by the PSM based on information available at that time i.e. before investigation. See section 7 on reports and Annexure E. The ISBAR report is the structured standardised format in which all events are reported. It stands for: Information, Situation, Background, Assessment 5.8. If an agency staff members are involved in the event, they must complete the electronic Safety Event Report on the Safety Event Management System and a copy should be sent to their agency by the PSM. 5.9. If no further investigation is required, the event can be ‘closed’, the Reporter sent feedback if they provided their email details. 5.10. Classification of multiple events. The following principles should be applied: 5.10.1. Multi-Events occur when more than one individual or a group are impacted by harm. It may also be a pattern of events. 5.10.2. Events with the same cause should each be investigated individually with the necessary rigor to determine interconnected contributory factors. 5.10.3. The common causal factors or associations can be identified and effective improvements can be implemented to prevent future events. Patient Safety Event Management Policy MCSA C.8.3 Page 14 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. 6. Investigation using Systems Analysis Approach (for only severe or death or SRE related events) (Step 6) 6.1. The purpose of investigating events is to find out what happened, why it happened and what learning can be gained. It consists of 4 key steps:  Preliminary investigation to gather more facts and data  Meeting with the HCWs involved  Collation of information  Review by the Serious Event Management Team (SEMT) 6.2. A preliminary investigation by the PSM, should include the gathering of the following:  Initial facts of the event as reported by the HCWs and Unit/Line Manager with supplemental attachments on the Safety Event Management System.  The patient’s file, a visit to the location to simulate the event and an examination of the items involved,  Any relevant policies, procedures, literature,  Previously reported events of a similar nature in the hospital or unit,  A consultation with colleagues or experts in the field. 6.3. Meeting with HCWs: The PSM, in consultation with the Unit Manager must coordinate a meeting as quickly as possible after the event to allow staff to tell their story. This meeting should be scheduled to allow for minimum interruption so that each person can tell their part of the story and further explore possible contributing factors or insights that have previously been overlooked. 6.4. Collation of information: The PSM with the Unit Manager should analysis the data and establish the chronology of events that led up to the event. They should identify:  Contributory factors that may have increased the likelihood of occurrence and influenced the eventual harm  Recommended actions to decrease the likelihood of recurrence and reduce the level of harm as far as reasonably practicable. The Unit Manager is responsible for ensuring that actions determined are suitable for that event and how these must be implemented by the unit staff.  Potential learning gained from the event (what went right and wrong) that needs to be shared locally or with a wider audience. 7. Review by the Serious Event Management Team (SEMT) (Step 7) 7.1. The Serious Event Management Team (SEMT) must be established to review the investigation conducted on serious harm or death events or those classified as SREs. 7.2. The SEMT consists of the Review Team members plus any medical practitioner or therapeutic support healthcare providers who were involved in the care of the patient, and any other person who can add specific technical/specialist knowledge to the type of event being investigated such as the pharmacist, technical team. The SEMT must include the HGM. Patient Safety Event Management Policy MCSA C.8.3 Page 15 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  7.3. The Regional Clinical Manager (RCM) may be part of the SEMT team review, and may include other Corporate Office team members such as the Clinical Performance Team, Nursing Quality Specialists from the Corporate Office Clinical Services department, Pharmacy or IPC departments. Regional and Corporate Office team members must be involved if the event is a SRE. The Regional Operations Executive may also be involved as needed. 7.4. The main purpose of the SEMT review meeting is to:  Identify and define relationships between contributing factors and establish a root cause,  Develop and manage recommended actions to address the root cause and reduce the risk of recurrence,  Actions planned must be appropriate to the level of harm, following the Just Culture principles. These actions must be documented individually in the Event Management System with a due date and a responsible individual.  Ensure that a suitable monitoring system is in place to track actions and impact, and Close the loop by identifying what must be shared from what was learned (internally and externally) at the most appropriate meetings in the hospital and within MCSA. 7.5. Final Team Review (Step 7), reporting and event closure 7.5.1. The Final Review of the event will be done by the Serious Event Management Team to determine whether to further investigate the event or to close it. Events, where the treatment of the patient is ongoing after discharge, will need to remain in investigation until the care has been completed. 7.5.2. The Risk Assessment Scale should be completed. Information gathered in the risk assessments can assist the hospital and MCSA to have a clearer indication regarding clinical risk over a period. ( 7.5.3. The risks should also be recorded in the CURA risk register 7.5.4. The investigation outcomes are compiled in the ISBAR or Root Cause Analysis report by the PSM. Annexure E for example of the ISBAR report content. 7.5.5. Event should then be closed on the Safety Event Management System by the PSM. Feedback on safety events to patients and staff 1. Guidance from the Legal Department must be obtained in order to advise on all discussions or feedback with/to the patient/visitor and/or their family 2. During the final stages of the Review Team steps, it should be decided how feedback should be given to the patient and their family. Ideally, the support of the PxM should be provided during this engagement. 3. The unit staff should be provided with feedback by the Unit Manager and PSM. Actions to prevent future harm events must be clearly described and responsible individuals assigned. 4. If the person reporting the event provided their email address, they will also receive a report of the outcome of the event investigation in the form of an After Action Review report once the event is closed. Patient Safety Event Management Policy MCSA C.8.3 Page 16 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. 5. The Hospital, Regional and Corporate Office Clinical Governance team members will also receive the final report for all events that have been closed after completed investigation. Type of Reports on the Safety Event Management System 1. After Action Review report – for all events as compiled by the Unit/Line Manager.: 2. Provisional report - – for all events that are SREs and serious harm or death or were investigated and is completed at the time of First Team Review. 3. Final report – For all SRE’s and serious harm events with a detailed systems analysis investigation. It contains the London Protocol contributing factors as well as input from corporate office at the time of the SEMT meeting. 4. Root Cause report – this is an alternative format to complete when a detailed systems analysis investigation has occurred for serious harm and death events. It contains the London Protocol contributing factors as well as a determination of the root cause of the event with clear action plans and timeframes for corrective measures. This is the preferred reporting format for Serious Harm and Death events and a template is provided on the Safety Event Management System. Timeframes for reporting and management of events All safety events should be loaded and managed to closure or if it is a SAE in final review on the Safety Event Management System by the 7th of the next month, i.e. all March events must be loaded and managed by the 7th of April in order to ensure they are reflected in the Clinical Indicator Reports. Should the event be complicated and require additional time, the PSM may request such additional time from the RCM. Action to be taken Time - By when By whom Report a safety event Before or by end of shift All staff AAR and contributing factors 5 working days from event reported Unit / Line manager Categorise and finalise with 10 working days from event PSM Review Team reported Serious reportable events that 15 working days from event PSM require system analysis for reported investigation by SEMT Alerts and notifications from the safety event management system 1. All events captured on the Safety Event Management System will automatically go through a workflow process. The PSM will be able to email the Unit managers when an event requires an AAR to be completed should they not have access to the Safety Event Management System. 2. Only once an event is closed will the Hospital Governance Team receive a notification with the relevant final report. The Reporter will also only receive their feedback by email one the event is closed. 3. Alerts will be sent for SREs and those with severe harm or death at the time they are loaded onto the Safety Event Management System by the Reporter and/or categorised by the PSM. Patient Safety Event Management Policy MCSA C.8.3 Page 17 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Each hospital needs to set up an alert distribution email group for these alert emails. 3.1 The alert email groups should be maintained by a person allocated to do so in the hospital, who should either be the PSM or the HCM / NM. This includes ensuring that if an individual changes their role or position the email group is adjusted and if any new members join, they are added. 3.2 Alert distribution email name: [email protected] (Hosp ID is the same 3 letter abbreviation of the hospital name as per the financial list) 3.3 The following individuals in these roles must be included in the email  Nursing manager, Deputy Nursing manager(s)-, Night Duty manager(s)-, , Day Clinic Manager, Patient safety manager, Infection prevention control manager  Hospital Clinical Manager,  Pharmacy Manager and where relevant the ward and/or clinical pharmacists  Regional Managers - Regional Operations Executive, Regional Clinical Manager (this is optional) Actions to be taken following a Safety Event 1. Actions should be documented in either the AAR or in the ISBAR or RCA reports to address safety events that have occurred. 2. The Unit Manager is responsible for ensuring that the actions planned are completed by the unit’s staff or supported by the relevant individuals in the hospital 3. In developing actions to address Safety Events the SMART principles should be used – they should be specific, measureable, achievable, realistic, time based 4. Actions should include the specific task to be performed, by whom and by when. 5. The PSM must work with the Unit Managers in units where there are specific quality, patient safety and clinical risk concerns to understand the data in more detail and determine continuous improvement ideas. 6. Where improvement initiatives are required, the Unit Manager drives these initiatives and supports HCWs to develop change ideas. The PSM along with the IPC Manager and pharmacists are responsible for providing expert input and guidance to develop improvement ideas and measure the impact of changes. 7. The Continuous Improvement methodology using the DMAIC methodology (Define, Measure, Analyse, Improve, and Control) described below should be used to undertake any continuous improvement initiatives. Refer to the Guideline for Structured Problem Solving for further details. 8. The tracking of status of these actions should occur monthly by the Unit Manager and should be reported to the Forum reviewing quality, patient safety and clinical risk monthly. 9. Reporting of specific events to the Office of Health Standards Compliance Early Warning System indicators after confirmation with the RCM. Additional Actions to be taken following a Never Event 1. Within 48 hours of the event being reported on the Safety Event Management System or by the next working day after a weekend/public holiday, the event report with the unique event number must be emailed to the Regional Clinical Manager (RCM), the Operations Executive (OE), the Chief Operations Officer and individuals at corporate office. The corporate office individuals include; Clinical Quality Specialist: Theatre, Clinical Patient Safety Event Management Policy MCSA C.8.3 Page 18 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  Performance Team , General Manager Clinical Services, Chief Clinical Officer, Funder Relations and Nursing Executive; 2. A date to discuss the event must be set by the hospital and invitations send out to the RCM,ROE, Clinical Quality Specialist: Theatre, Clinical Performance Team CO , General Manager Clinical Services, and Nursing Executive within 2 weeks of the event occuring. Doctors involved in the event should be present at this meeting which serves as a SEMT final team review. 3. The final report must be completed on the Safety Event Management System prior to the SEMT final team meeting. 4. After the event discussion, the final review will be updated. Corporate Office individuals may document any actions that will be taken at their level prior to the event being closed. 5. Only then may an event be closed. Additional actions to be take following a maternal and neonatal deaths 1. Maternal events 1.1. All maternal deaths should be reported on the Safety Event Management System and an investigation performed as per the SRE process in addition to the normal notification process of maternal deaths to the DOH or Ministry of Health in Namibia. 1.2. All maternal deaths in South Africa are notifiable to the Department of Health and are reviewed by the National Committee for Confidential Enquiry into Maternal Deaths (NCCEMD) who releases a ‘Saving Mothers Report’ with the findings and recommendations for obstetrics in South Africa. 1.3. A maternal death is classified as any woman who dies during her pregnancy and for up to 42 days post-delivery. There are 3 groups of maternal deaths: 1.4. Direct maternal death – a mother who has died from a pregnancy complication e.g. had an obstetric haemorrhage or pre-eclampsia and dies directly as a pregnancy complication. 1.5. Indirect maternal death – a mother who is pregnant but dies from a disease that’s complicated by the pregnancy e.g. HIV. 1.6. Accidental maternal death – a mother who may be in a car accident and was pregnant at the time. 1.7. All maternal deaths should be discussed at the Mother and Baby Collaborative Meeting. 2. Neonatal events 2.1 The following categories of neonatal mortalities and severe harm must be reported on the Event Management System and full investigations must be completed :  Death of a term foetus during labour or delivery  Death of an asphyxiated baby  Death or hypoxic ischaemic encephalopathy following the birth – the investigation must focus on the labour and delivery (midwife and doctor) and on the initial resuscitation and management in the NICU (neonatal staff and doctor) so will be a combined investigation and will be discussed at the Mother and Baby Collaborative  A baby in the neonatal ICU that dies after the first week of life or after a period of stability (no longer requiring ventilation, tolerating feeds) and deteriorates and dies Patient Safety Event Management Policy MCSA C.8.3 Page 19 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. 2.2 Neonatal events that must be reported as mild/moderate or serious harm and an investigation must be completed:  Any baby that develops confirmed necrotizing enterocolitis 2.3 The following neonatal events DO NOT need to be reported  Babies that have a known congenital abnormality or are not expected to survive due to a known pregnancy complication  NB a baby with a severe congenital anomaly that is incompatible with life, a preterm baby that starts off poorly and never recovers, or an extremely preterm baby of less than 26 weeks gestation should not be reported 2.4 If unsure whether to report or not - the clinical quality specialist: child health should be contacted Actions to be taken following a healthcare-associated infection 1. Healthcare-associated infections cause significant harm to patients as they impact on the length of stay or level of care of these patients and may result in significant morbidity or even death. They are managed by the Infection Prevent Control Manager (IPCM) as the expert on ICNet infection control system. 2. Unit managers must ensure that any suspected or confirmed infection (HAI or community acquired infection) is reported to the IPCM using the N0983 Notification: Potential Infection form. The IPCM and the unit manager will then perform interventions as per the Policy: Infection Prevention & Control Surveillance. 3. The Unit Manager must support the IPCM with the investigation of HAIs. This task may be delegated to the IPC Link Nurse. 4. The IPCM will organise and lead the HAI investigation. The Unit Manager, in collaboration with the IPC Link Nurse and IPCM, should actively participate in the investigation and development of interventions to prevent recurrence. 5. The IPCM will document findings of the investigation on the IPC surveillance system (ICNet). 6. The IPCM and the PSM may coordinate their efforts in collaboration with the Unit Manager in continuous improvement initiatives for HAI events where necessary. Associated documents and records Title Number Location MCGS Corporate policy: Prevention of Slips, Trips MCSA.C.N.1.3 Intranet and Falls (March 2019) MCGS Group Framework for Event Management Intranet September 2021 HR Employee Relations made Practical Manual Intranet and Workbook, May 2019 policy Patient Safety Event Terminology Guideline Intranet Structured Problem Solving using Continuous Intranet Improvement methodology Policy: Management of Clinical Performance and Intranet Clinical Risk MCSA Corporate policy: Management of the MCSA.C.N.1.4 Intranet Deceased Policy Patient Safety Event Management Policy MCSA C.8.3 Page 20 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  MCSA Corporate Policy: Infection Prevention & Intranet Control Surveillance Safety Event report CL0857 Intranet Quality Improvement: Event Investigation N2838 Discontinued Notification: Potential Infection N0983 Intranet References 1. Agency for Healthcare Research and Quality. (2015) Patient Safety Network: Systems Approach. https://psnet.ahrq.gov/primers/primer/21 2015. 2. Angood, P., Colchamiro, E., Lyzenga, A., and Marinelarena, M. (2009). Meeting of the National Quality Forum Patient Safety Team. Washington, DC. Unpublished. 3. Batalden P, Davidoff, F. (2007). ‘What is “quality improvement” and how can it transform health care?’ Qual. Saf. Health Care; 16: 2-3. 4. Canadian Patient Safety Institute (CPSI). (2007) Delivery Patient Safety Multi Media Resource for Healthcare Professionals. 5. Edmondson A. (1999) “Psychological Safety and Learning Behavior in Work Teams”; Johnson Graduate School of Management, Cornell University. Administrative Science Quarterly, Vol. 44, No. 2, pp. 350-383 6. Hurtado MP, Swift EK, Corrigan J. (2017). Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press. 7. JCIA standards for hospitals (2017), 6th edition effective 1 July 2017 8. Karsh B, Alper SJ. (2006). Work System Analysis: The Key to Understanding Health Care Systems. Agency for Healthcare Research and Quality, Patient Safety Network, http://www.ahrq.gov/ 9. Karsh B, Alper SJ. (2005). Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology), https://www.ncbi.nlm.nih.gov/books/NBK20518/ 10. Langley GL, Nolan KM, Nolan TW, Norman CL, Provost LP. (2009). The Improvement Guide: A Practical Approach to Enhancing Organizational Performance (2nd edition). San Francisco: Jossey-Bass Publishers. 11. Kohn LT, Corrigan JM, Donaldson MS. (2000). To err is human: building a safer health system. A report of the Committee on Quality of Health Care in America, Institute of Medicine. Washington, DC: National Academy Press. 12. Macrae C. (2015). The problem with incident reporting. BMJ Quality & Safety Online First. 13. Rooney JJ, Van den Heuvel LN, Lorenzo DK. (2002). Reduce Human Error: How to analyze near misses and sentinel events, determine root causes and implement corrective actions. www.asq.org. 14. National Health Service: National Reporting and Learning Service (NHS SNRL). (2004). Seven steps to patient safety: full reference guide www.npsa.nhs.uk/ seven steps. 15. Nolan TW. Execution of Strategic Improvement Initiatives to Produce System- Level Results. IHI Innovation Series white. 16. Nolan TW, Provost LP. (1990). Understanding Variation, Quality Progress, Vol. 13 (5). 17. Scoville R, Little K, Rakover J, Luther K, Mate K. (2016). Sustaining Improvement. IHI White Paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; (Available at ihi.org) Inline references I. JCI Ambulatory care definition for adverse event II. JCIA, Standards for Hospitals, 6th edition effective 1 July 2017 III. https://psnet.ahrq.gov/primers/primer/34/adverse-events-near-misses-and-errors (2016) IV. Angood et al, 2009 V. JCIA, Standards for Hospitals, 6th edition effective 1 July 2017 VI. “Psychological Safety and Learning Behavior in Work Teams”; Amy Edmondson; Administrative Science Quarterly, Vol. 44, No. 2 (Jun., 1999), pp. 350-383 Published by: Johnson Graduate School of Management, Cornell University Stable URL: http://www.jstor.org/stable/2666999 VII. https://www.eurocontrol.int/initiative/just-culture VIII. Karsh and Alper, 2006 IX. Batalden, P. B., & Davidoff, F. (2007). What is "quality improvement" and how can it transform healthcare? Quality & safety in health care, 16(1), 2–3. doi:10.1136/qshc.2006.022046 Patient Safety Event Management Policy MCSA C.8.3 Page 21 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  X. Norms and Standards Regulations Applicable to Different Categories of Health Establishments; National Health Act (no 61 of 2003) XI. AHRQ, 2015 History and version control History Author Version Details of update Effective Approver date Yolanda Walsh 4.0 Updated 2013 Dr Stefan Smuts Ansie Prinsloo 5.0 Create and update processes, 2017 Dr Stefan definitions, user guide including that Smuts for Serious adverse events. Ansie Prinsloo 5.2 Update with HEM user guide August Dr Stefan 2017 Smuts Ansie Prinsloo 6.0 Updated with national hospital March Dr Stefan feedback and issued as Policy 2018 Smuts Dr Kim Faure 7.0 New algorithms for determination of 19 July Dr Stefan type of event. Additional definitions 2019 Smuts and inclusion of Never Events definitions. Updated process flow for reporting including role descriptions. Removal of non-patient harm events from patient safety responsibilities. Dr Kim Faure 8.0 Alignment with the new safety event 11 October Dr Gerrit management system and Group 2021 de Villiers Framework. Inclusion of requirements for Office of Health Standards Compliance. Dr Kim Faure 8.1 Updated to follow the new process 17 March Dr Gerrit flow for the Group Framework for 2022 de Villiers Event Management Policy and align with the Office of Health Standards Compliance regulations. Includes communication actions with legal and on Never Events. Removal of the clinical risk structures as these form part of a new policy. Dr Kim Faure 8.2 Timelines updated, Never event 1 Dr Gerrit reporting updated and separation September de Villiers out of Clinical Risk process and 2022 committee Patient Safety Event Management Policy MCSA C.8.3 Page 22 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Approval and sign-off New version Contributors Name Designation Clinical Services Louise Aylward Nursing Operations Manager Clinical Services Anna-Marie Crumplin Clinical Performance Operations Specialist Author Dr Kim Faure Clinical Performance Manager Details of update Inclusion of updated SRE and never event definitions. Level of harm clarification. Changes to legal communication. Just culture guide and QI removed and will be incorporate in training material. Version number 8.3 Effective date 2023 05 16 Review date 2028 05 16 Approved by Department/Area/ Representative Signature Designation Date Group/Forum name Clinical Services Dr Gerrit de Chief Clinical 2023 05 15 Villiers Officer Patient Safety Event Management Policy MCSA C.8.3 Page 23 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. ANNEXURE A – Serious Reportable Events Some events occur in healthcare where the learning potential is so great, or the consequences to patients, families, and staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. They include never events. These events are unambiguous if not entirely preventable, serious, and any of the following:  Potential for serious adverse outcomes indicative of a problem in a healthcare setting’s safety systems  Important for public credibility or public accountability  Additionally, items included on the list are events that are: o Of concern to both the public and healthcare professionals and providers. o Identifiable and measurable; and thus, feasible to include in a reporting system. o Of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the healthcare facility. Process 1 There are specific types of events which will be included as SREs based on the type of the event, no inclusion or exclusion criteria will apply Process 2 In addition, any event where the level of harm has been classified as severe harm and death is included in the count of SREs Process 3 The total number of SRE = Process 1 + 2 + Never events Behaviour event 1. Physical contact (actual assault) a. Towards staff by a patient; Towards staff by a Visitor/Other; Towards a Patient by a Patient; Towards a Patient by a Visitor/Other; Towards a Patient by Staff 2. Sexual, rape, indecent exposure 3. Missing patient a. Abduction b. Missing minor (new-born to children up to 13 years of age) 4. Patient restraint processes - Incorrect patient 5. Persons performing unauthorised acts - Care provided to patients by bogus professionals 6. Self-harming behaviour a. Actual self-harm b. Self-harm attempt/gesture c. Other self-harming behaviour d. Suicide (actual) e. Suicide attempt/gesture (not overdose) f. Suicide attempt/gesture (overdose) 7. Use/Possession of Prohibited/Stolen Goods - Unauthorised use of weapon Blood/Plasma Products 1. Administration to patient - Incorrect patient 2. Patient monitoring during and post-transfusion a. Death, suspected to be the result of a transfusion b. Transmission of chronic/fatal disease due to infusing blood/blood products Patient Safety Event Management Policy MCSA C.8.3 Page 24 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Clinical Administrative Discharge of a patient, who is unable to make decisions, to unauthorised person Diagnostic therapeutic 1. Performed on incorrect patient a. Diagnostic Conclusions b. Assessment/Evaluation/Examination/Triage c. Investigations/Interpretations d. Radiological/Imaging Investigations/Interpretations e. Monitoring of Patient Status f. Non-invasive Treatment Process/Procedure g. Patient Restraint Process h. Radiation Therapy 2. Not available or missing laboratory investigations - Irreplaceable biological specimen e.g., biopsy 3. Artificial insemination with the wrong donor sperm or wrong egg 4. Resuscitation process - Performed on incorrect patient 5. Radiation overdose due to wrong treatment or due to environmental hazard Environmental hazards 1. Exposure to Hazardous substances - Blood or body fluids and Other i.e., sharps injury, splash in eye 2. Unsafe environmental conditions: Evacuation of the hospital for any reason (full or partial), Explosion, Fire, Radiation over exposure. Falls Patient outcome either: Intracranial injury, fracture; dislocation; laceration requiring suturing, death, paralysis, coma or major permanent loss of function. Medical devices/Equipment/Supplies 1. Implantable device - Event resulted in removal of device 2. User/utilisation process - Incorrect patient Medication 1. Administration to incorrect patient 2. Patient Monitoring a) Adverse drug reaction including post immunisation b) Medication error resulting in patient death, paralysis, coma, or other major permanent loss of function Medical gas events Administration to: Incorrect patient, incorrect gas/gaseous mixture, Gas contaminated by a toxic substance. Nutrition (Pharmacy products) Administration to patient - Incorrect patient Other Unexpected Deaths or Severe Harm unrelated to the patient’s natural course of illness or underlying condition Patient Safety Event Management Policy MCSA C.8.3 Page 25 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. Perinatal event 1. Maternal Death 2. Maternal injury to body part, organ, or vasculature a. Unscheduled hysterectomy b. Uterine rupture c. Ureter d. Bladder e. Bowel f. Vasculature g. Perineal tear or laceration, 3rd or 4th degree h. Other injury to body part, organ, or vasculature 3. Perinatal event – Unexpected death Intra-Uterine, Intra-Partum or Post-Partum 4. Neonatal a. Subdural or cerebral haemorrhage b. Injury to brachial plexus, including Erb's or Klumpke's paralysis c. Clavicle fracture d. Hypoxic ischemic encephalopathy (HIE) e. Seizure(s) f. Exchange transfusion for severe hyperbilirubinemia g. Exposed to wrong breast milk h. Sent home with the wrong parents i. Unexpected death Perioperative event 1. Anesthesia care (includes conscious sedation) a. Incorrect patient b. Incorrect inhalation anaesthetic agent/ gas mixture or dose c. Incorrect non-inhalation anaesthetic agent or incorrect dose d. Failed intubation e. Insufficient airway management f. Insufficient sustainment of general anaesthesia g. Failure to recognise and respond to significant change in patient status 2. Death: Intraoperative or postoperative 3. Physiological complications not present prior to surgery a. Air embolus b. Iatrogenic pneumothorax c. Paralysis, coma, or major permanent loss of function 4. Burn e.g. diathermia and/or operating room fire 5. Unintended laceration or puncture: Diagnosed / not diagnosed and managed during primary procedure 6. Organ transplant - Unintended transplanting contaminated organs or tissues Personal Property/Data/Information 1. Confidentiality/Privacy breach, Intentional or Unintentional 2. Unauthorised Access/Disclosure Pressure injury 1. Hospital-acquired, Stage 3, Stage 4, Unstageable 2. Present on admission but deteriorated in hospital: Stage 3, Stage 4, Unstageable Patient Safety Event Management Policy MCSA C.8.3 Page 26 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version. ANNEXURE B – Non Safety events Non Safety Events: These are events that occur without a direct impact on the safety of a patient but relate to other concerns, for example medication breakages/expiration, occupational injuries. 1. Management of technical/medical equipment events Only equipment events where there was harm or potential harm to patients must be loaded on the Safety Event Management System. All equipment failures or malfunctions detected during routine checks or before use on a patient must be reported using the suitable technical process for such events and not on the Safety Event Management System. These must be reported on the Fraud & All lost incident form OP1120. 2. Management of occupational injuries (Permanent and Agency staff) 2.1 Event reported on system by staff member involved / injured in incident. 2.2 AAR and contributing factors must be completed by the Unit manager in which unit the injury occurred. 2.3 The UM to complete the normal Workman’s Competition Association forms for the event. 2.4 PSM will categorise and close the event. 2.5 PSM or Unit Manager can send the event and AAR in PDF format off the Safety Event Management system to: 2.5.1 INCON or occupational health service provider if permanent staff are involved. 2.5.2 MHR / Agency representatives when agency staff are involved. 3. Management of pharmacy events 3.1 For breakage, product failure or an event involving expired medication an event should be reported. Schedule 0, 1, 2, 3 & 4 medication / pharmaceutical product  The medication/product is sent to the pharmacy in a suitable bag marked with the event reference number for evaluation, safe disposal and accurate adjustments of stock levels as per protocol. Schedule 5 & 6 medication  The unique event number is recorded and the physical evidence kept in the Schedule 5 & 6 cupboards in the unit.  The evidence is collected by the pharmacist with the event reference number for evaluation, safe disposal and accurate adjustments of stock levels as per protocol. The schedule 5 & 6 registers are updated and signed by relevant individuals as required. 1.2 AAR and contributing factors must be completed by the Unit manager if the event occurred in the wards. 1.3 AAR, contributing factors and taxonomy (under Medication/Biologics/Fluids) must be completed by the Pharmacy Manager if the event occurred in the pharmacy or emergency cupboard. 1.4 The Pharmacy manager should classify, and if required send the event for further investigation or review by the relevant individuals and close the event. 1.5 The Pharmacy will use the event number, to write off the medication on the Pharmacy Stock Management system, in the comment section. Document the details of the event in the Schedule 5 & 6 Pharmacy Wastage/ Expired Register until approval from the Patient Safety Event Management Policy MCSA C.8.3 Page 27 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  SAHPRA to destruct the medication. The Pharmacy will attach a label with the event number onto the evidence until destruction. ANNEXURE C – Never Events Mediclinic International – Never Events Factsheet (December 2022) Never Events are defined as clearly identifiable events related to clinical treatment that have led to patient harm. Each Never Event type must be able to be clearly defined and its occurrence easily recognised – this requirement helps minimise disputes around classification and ensures focus on learning and improving patient safety. Rationale for focusing on Never Events Never Events are patient safety incidents that are largely preventable through the implementation of known and available guidelines or safety recommendations that provide strong systemic protective barriers and which have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event. For each Never Event type, there is evidence that the Never Event has occurred in the past – for example, through previous reports and that the risk of recurrence remains. Never Events can occur in various settings within healthcare and are grouped into: Surgical/invasive procedure, Medication, Mental Health and General Surgical/invasive procedure All invasive surgical and other procedures whether in theatre or not, are included in this policy with the inclusion and exclusions listed below. ‘Surgical/ invasive procedure’ includes interventional radiology, cardiology, interventions related to vaginal birth and interventions performed outside the surgical environment – for example, central line placement in ward areas. The placement of peripheral IV lines, phlebotomy and insertion of urinary catheters is not included in this policy as this is not in line with the NHS definitions (see below under wrong patient invasive procedure or surgery for more detail). Surgery is defined as an invasive operative procedure in which skin or mucous membranes and connective tissue is incised or an instrument is introduced through a natural body orifice. Surgery begins, regardless of setting, at the point of surgical incision, tissue puncture, or the insertion of an instrument into tissues, cavities, or organs and ends after counts have concluded, the surgical incision has been closed, and/or operative device(s) such as probes have been removed, regardless of setting (e.g., post-anaesthesia recovery unit, surgical suite, endoscopy unit). The surgeon is the responsible person regarding the surgical outcome of a patient, they are supported by all team members (including representatives) who should adhere to surgical/invasive procedural policies and procedures to prevent the occurrence of Never Events. 1. Wrong patient invasive procedure or surgery An invasive procedure or surgery performed on the wrong patient. Includes:  Interventions considered to be surgical, but which may be done outside a surgical environment – for example, nerve block (including blocks for pain relief), biopsy, Patient Safety Event Management Policy MCSA C.8.3 Page 28 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.  interventional radiology procedure, cardiology procedure, drain insertion and line insertion (e.g., peripherally inserted central catheter (PICC)/ Hickman lines).  Includes procedures/surgery performed on the incorrect patient due to more than one patient on the list or hospital with the same or similar names  Wrong patient vaginal interventions during birth (e.g., rupture of membranes, epidural)  Wrong patient anaesthetic Excludes:  Blood taken from wrong patient *  Peripheral short IV-line insertion on wrong patient *  Insertion of urinary catheter in wrong patient *  Blood transfusion to wrong patient * [*Although these aren’t “never events” they must be classified as serious reportable events as they point to serious errors in patient identification] 2. Wrong site or side Invasive procedure or surgery An invasive procedure or surgery performed at the wrong site (e.g., wrong knee, eye, limb, ) or side (left vs right) that is not consistent with the documented informed consent and booking or planning for that patient or as documented in the patient notes by the doctor or nurse for unit based invasive procedures. The incident is detected at any time after the start of the procedure. Includes: Interventions that are surgical but may be done outside a surgical environment – for example, wrong site block (including blocks for pain relief), biopsy, interventional radiology procedure, cardiology procedure, drain insertion and line insertion (e.g., peripherally inserted central catheter (PICC)/ Hickman lines). Excludes:  removal of wrong teeth  local anaesthetic blocks for dental procedures interventions where the wrong site is selected because the patient has unknown/unexpected anatomical abnormalities; these should be documented in the patient’s notes at the time of discovery  wrong site surgery due to incorrect laboratory reports/results or incorrect referral letters  contraceptive hormone implant in the wrong arm  Wrong level spinal surgery 3. Wrong surgery or invasive procedure performed An invasive procedure or surgery performed that is not consistent with the correctly documented informed consent and booking or planning for that patient. This includes “incomplete surgical procedures” where more than one procedure is scheduled however one of the procedures is not performed due to failure to perform the safety checks. Includes:  Caesarean section with sterilisation, but the sterilisation is not done during the same procedure.  Endoscopy procedures e.g., gastroscopy performed instead of a colonoscopy, even if a colonoscopy is also performed subsequently. Excludes: Patient Safety Event Management Policy MCSA C.8.3 Page 29 of 34 Effective date: 2023 05 16 The printed copies of this document shall be treated as uncontrolled. Please refer to the online version for the latest version.   Interventions where the surgery or procedure is changed due to unknown/unexpected anatomical abnormalities; these should be documented clearly in the patient’s notes.  surgery is intentionally different from that specified in the surgical plan, based on clinical judgement at the time of the procedure  The intended (consented) procedure is intentionally not completed due to the operative risk, complexity or patient factors e.g., where widespread metastasis is detected at laparotomy and a booked colectomy not performed. The reason for this decision should be documented in the patient notes. 4. Wrong implant or prosthesis Placement of an implant/prosthesis different from that specified in the procedural plan, either before or during the procedure as documented in the theatre or procedure booking or doctors notes. There must be a check between the surgeon and both the scrub practitioner and the surgical representative to confirm that the implant/devices/prosthesis is the correct