National Guideline for Patient Safety Incident Reporting and Learning PDF

National Guideline for Patient Safety Incident Reporting and Learning Training module for patient safety incident (PSI) reporting and learning Training module 1 – Introduction and general overview Directorate: Quality Assurance...

National Guideline for Patient Safety Incident Reporting and Learning Training module for patient safety incident (PSI) reporting and learning Training module 1 – Introduction and general overview Directorate: Quality Assurance Ronel Steinhöbel Training Modules for Patient Safety Incident Reporting and Learning Four training modules: 1 Introduction and general overview Management of PSIs 2  Part 1 - Step 1 to 5  Part 2 - Step 6 to 9 PSI Classification examples and explanations 3  Part 1 - Incident type  Part 2 - Contributing factors and Outcomes 4 Implementation, reporting and learning  Contents: Training module 1 1 Why is patient harm a global priority? 2 Why develop a national Patient Safety Incidents (PSI) Reporting and Learning Systems (RLS) 3 Revision of the guideline 4 Purpose and objectives 5 Legal and policy framework 6 Scope 7 Mandatory requirements 8 Definitions 9 What is reported? 10 Steps to manage PSIs 11 Progress made since implementation  Why is patient harm a global priority? Patient harm due to adverse events is one of the top 10 causes of death and disability in the world. High-income countries - about 1 in 10 patients are harmed while receiving hospital care. Low and middle-income countries - about 134 million adverse events occur annually in hospitals, contributing to 2.6 million deaths every year. 15% of total hospital expenditure is a direct result of harmful incidents  Why develop a national PSI reporting and learning system? First Guideline implemented 1 Apr 2018: No national uniform system to report patient safety incidents number and type of PSIs not known improvement strategies? World Health Organization’s (WHO) call for all countries to have a national system for PSI reporting and learning. Increasing cost of litigation cases in health sector - Medico-Legal Summit hosted by the Minister of Health in March 2015 Recommended that a uniform National Reporting System be developed. Audits results from Office of Health Standards Compliance (Regulatory body): 35% compliance for management of PSIs.  Revision of the Guideline Revision was prompted by two documents: 2020/21 National Annual PSI WHO’s Global Patient Safety report – Action Plan 2021-2030 – included an analysis of the contains core and advanced data reported on the National indicators that countries must PSI Reporting and Learning report on. System (RLS) over a two-year period (2018/19 and 2019/20)* Version two approved in 2021 Implementation 1 April 2022 * Supported by Better Health Programme South Africa - managed by Mott MacDonald  Why were the revisions done in 2021? Annual report  analysis of classifications did not provide meaning to the full aggregated data: o additional sub-classifications were required o staff did not correctly classify incidents Use of the classification for ‘Other’ for type of PSI constituted 25% Global patient safety action plan 2021- 2030  Add additional classification to report on WHO advanced indictors  What was revised in Version 2? Classifications revised for:  type of PSI,  contributing factors,  outcome and  severity assessment code (SAC) PSI definition: Definition was reviewed to ensure that everyone has the same understanding of what a PSI is. A decision tree to guide staff to correctly to identify a PSI was added. PSI reporting form:  rearranged to allow for a logic flow.  classifications were updated  prompts were added into some fields to guide staff Added an algorithm to guide a just assessments of individual acts of staff based on the Just Culture.  Purpose of the Guideline Provide direction to the public health sector of South Africa regarding the management of Patient Safety Incident (PSI) reporting, Give guidance on appropriate feedback to patients, families/support persons and clinicians, and Share lessons learned to prevent reoccurrence of patient harm.  Objectives of the Guideline Create a framework to guide the implementation of a PSI RLS Assist facilities to comply with the norms and standards regulations applicable to different categories of health establishments (2018) Prevent and / or reduce harm to patients whilst undergoing medical care Standardise definitions, classifications, methodology for reporting, investigating, and responses to PSIs Ensure that statistical data on PSIs is available for planning and decision making Learn from data reported on PSIs to prevent reoccurrence Ensure that preventative measures are put in place Continuously improve quality of care Ensure appropriate communication with patients  Legal and policy framework National Health Act no 61 of 2003 National Health Amendment Act 12 of 2013 Ethical rules for health practitioners National Patients’ Rights Charter Health Professions Amendment Act 29 of 2007 Births and Deaths Registration Act 51 of 1992 Inquest Act (as amended) Mental Health Care Act 17 of 2002 Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended Regulations relating to blood and blood products (no.179)  Scope Applies to: Public health establishments of South Africa Clinical staff and non-clinical staff Defines: Roles and responsibilities Mandated reporting requirements Timeframes Facility/district/provincial and national level processes for aggregation, analysis, learning and action on incidents  Mandatory requirements according to Regulations All health facilities must have a system in place to manage PSIs* according to the following principles: Confidential Timely Just Responsive Culture Openness about Emphasis failures on learning * Norms and Standards Regulations applicable to different categories of health establishments (2018)  Definition of PSI A PSI is an unplanned or unintended event or circumstance that could have resulted or did result in harm to a patient while in the care of a health facility. This event is thus not due to the underlying health condition or natural progression of disease. PSI can be a near miss, no harm incident or harmful incident (adverse event). PSI Decision Tree to Identify a PSI Event occurred Event occurred whilst the patient was NOT in the care of health facilities Not reported as a patient safety incident Do you report it as a PSI? No!  Event occurred Event occurred whilst the patient was in the care of health facility Do you report it as a PSI? Hmmm – maybe – we need to ask more questions  Event occurred Event occurred whilst the patient was in the care of health facilities What does that mean? Event occurring from the natural progression of medical condition It means that the event occurred as a direct result of the patient’s medical Not reported as a condition, despite their patient safety incident treatment being provided in line with the appropriate clinical protocols Event occurred Event occurred whilst the patient was in the care of health facilities Event resulting from the delivery of care or event occurred while patient was receiving care Report as a patient safety incident  Event occurred And if the event does reach the patient but Event occurred whilst What happens if the patient was in the the patient is care of health facilities there is an event, unharmed? but it did not reach the patient – do I still report Event resulting from the delivery of care or event it as a PSI? Yes! occurred while patient was receiving care Report as a Yes! patient safety incident No harm incident: A no harm incident is an incident which Near miss: A near reached a patient, Incident does not reach Incident reaches patient miss is an incident patient but no discernible which does not harm resulted. reach the patient No harm incident Near miss  Event occurred Yes, if the harm is as And then, any incident a result of incorrect Event occurred whilst which results in harm to the patient was in the medical management care of DOH facilities the patient? or failure of the health service provided Event resulting from the delivery of care or event occurred while patient was receiving care Harmful incident (adverse event): is an incident that results in harm to a patient that is related to medical Report as a management, in contrast to disease patient safety complications or underlying incident disease. Incident does not reach Incident reaches patient patient No harm incident Harmful incident Near miss  Other Definitions Patient safety: Reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum Harm: Impairment of structure or function of the body and/or any harm arising there from, including disease, injury, suffering, disability and death, and may be physical, social or psychological Degree of harm: Severity and duration of any harm Error: Failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim Hazard: Circumstance, agent or action with the potential to cause harm Detection: Action or circumstance that results in the discovery of an incident Minimal information model: Refers to a minimal common architecture for the core concepts considered to be essential for information and comparison purposes of PSI reports  Other Definitions (Cont.) Mitigating factor: An action or circumstance that prevents or moderates the progression of an incident towards harming a patient Incident outcome: Impact upon a patient or an organisation wholly or partially attributable to an incident. Organisational outcome: Impact upon an organisation which is wholly or partially attributable to an incident Patient outcome: Impact upon a patient which is wholly or partially attributable to an incident Incident type: Descriptive term for a category made up of incidents of a common nature, grouped because of shared, agreed features. Resulting actions: Identify immediate or indirect action taken that relates to the patient or the organisation to improve the situation or prevent the reoccurrence of an incident.  What is reported? PSIs include: Harmful incidents, no harm incidents and near misses WHO’s Minimum Information Model (MIM) is used for PSI reporting. Information is classification according to:  Incident identification (patient (age & sex), time, location)  Contributing factor*  Incident type*  Incident outcomes (patient & organization)*  Resulting actions  Reporter  Free text (Summary of PSI & Findings/ WHO provided technical recommendations) assistance with development of the first guideline Better Health Programme – Mott MacDonald (UK) assisted with the revision * WHO Conceptual framework for the international classification for patient safety  What is reported? (Cont.) Severity Assessment Code (SAC): Three indicators:  PSI closure rate  SAC 1 reported within 24-hour rate  PSI closure rate within 60 working days  Management of PSIs Steps to follow for the management of PSI: Step 1: Identifying PSIs Step 2: Immediate action taken Step 3: Prioritisations Step 4: Notification Step 5: Investigation Step 6: Classification Step 7: Analysis Step 8: Implementation of recommendations Step 9: Learning 9 Steps  Progress made since implementation in 2018 Compliance Report generated from the web-based information system is used as a proxy to measure progress made with implementation of the National PSI guideline Compliance = PSI recorded or Null report  Number of PSIs reported from 2018 Note: high levels of reporting are not necessarily indicative of a less safe environment for the patient but instead could highlight a good reporting culture. National Guideline for Patient Safety Incident Reporting and Learning Soft copy available from: www.idealhealthfacility.co.za and https://www.knowledgehub.org.za END www.health.gov.za