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http://www.who.int/patientsafety WHO efforts to strengthen reporting & learning of patient safety incidents Itziar Larizgoitia Service Delivery and Safety World Health Organization Quality & Safety in Healthcare 2014 Slide 2 No conflicts of interest Slide 3 World Health Organization, 2014 Incorrect administration of a chemotherapy drug Slide 4 World Health Organization, 2014 Understanding the event and its circumstances is essential When adverse events happen in health care, it is essential to understand: What happened? Why did it happen? What were the consequences? What can be done to mitigate the harm caused by it? What can be done to avoid this from happening again? Slide 5 World Health Organization, 2014 Towards building learning organizations One of the most frustrating aspects of healthcare is the apparent failure of health-care systems to learn from their mistakes Too often neither health-care providers nor health-care organizations advise others when a mishap occurs, nor do they share what they have learned when an investigation has been carried out. As a result, the same mistakes occur repeatedly in many settings and patients continue to be harmed by preventable errors. WHO Draft Guidelines for Adverse Event Reporting and Learning Systems Slide 6 1.WHO goals in the area of reporting 2.Main directions 3.Next/upcoming areas 4.Discussion: relevance, fit for purpose, fit for needs Agenda Slide 7 World Health Organization, 2014 WHO Goals in the area of reporting and learning 1.To facilitate global learning about patient safety incidents 2.To facilitate convergence towards a common language and compatible data infrastructure 3.To canvass world expertise towards improving the science of reporting Reporting is fundamental to detect patient safety problems Slide 8 Main directions Towards a common language and data infrastructure Slide 9 World Health Organization, 2014 Core principles for developing learning organizations through systematic and organized data collection Slide 10 World Health Organization, 2014 Reporting systems Must be safe & free of punishment Must lead to a constructive response: Feedback & recommendations for change Better to triangulate with other sources Pending: Lack of framework for data collection and of agreed taxonomy an issue Slide 11 World Health Organization, 2014 The Conceptual Framework for the International Classification for Patient Safety Slide 12 World Health Organization, 2014 A patient safety incident is an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient. I Incident Detection Amelioriating Actions Preventing Actions Contributory Causes Slide 13 World Health Organization, 2014 Other key definitions Patient Safety: the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum. Patient safety incident: an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient. Error: failure to carry out a planned action as intended or application of an incorrect plan Near miss: an incident which did not reach the patient No harm incident: an incident which reached a patient but no discernable harm resulted Harmful incident (adverse event): an incident which resulted in harm to a patient Adverse reaction: unexpected harm resulting from a justified action where the correct process was followed for the context in which the event occurred. Slide 14 World Health Organization, 2014 Slide 15 Current direction: Minimal Information Model for Patient Safety Goal: To identify the minimal set of concepts & relationships, which are able to elicit minimal learning & favor communications across reporting systems The Minimal Information Model intends to be the core common elements of any reporting system, which can later be expanded to suit the specific needs of any user. Slide 16 http://www.who.int/patientsafety CF Draft MIMPS Testing & validation 2009 2012-2013 2014-2015 CS 2010 Categorial Structure Conceptual Framework Top-Down analysis mapping R&L systems University St Etienne Bottom-Up analysis NLP unformatted reports University of Tokyo Expert External Review & consultations Agencies Denmark, Belgium, Canada, Australia MIMPS Intergovernmental Agencies, National Agencies, Academia, Experts Slide 17 World Health Organization, 2014 Slide 18 THE INTERNATIONAL INFORMATION MODEL FOR PATIENT SAFETY (INTERMEDIATE) 1.Incident identification Patient Time Location 2.Incident circumstances Agent(s) involved Leading actions Ongoing actions (Causes)* (Contributing factors)* 3.Incident type 4.Incident outcomes 5.Resulting actions 6.Reporter Role in the incident * Causes and Contributing Factors are handled as a property of every action and agent involved Slide 19 World Health Organization, 2014 Validation of Minimal Information Model for Patient Safety Partners: European Union Validation of MIM in existing reporting systems Assessment of feasibility of adopting MIM Building a glossary of preferred terms for incident types Expanding understanding to elicit learning effectively Project plan in initiation Timeline up to 2015 To engage additional partners Slide 20 Next Steps in building a common language and data infrastructure Slide 21 Vigilance of Medical Devices Pharmacovigilance Slide 22 World Health Organization, 2014 Would MIM be helpful to specialty reporting systems? WHO consultation on 1-2 April to understand the extent of commonalities, divergence, and overlap To review the commonalities and main differences across key reporting and vigilance systems To scope the feasibility of a common minimal information model for safety incident reporting in health care Slide 23 Main directions To canvass world expertise towards improving the science of learning Slide 24 World Health Organization, 2012 Concise Incident Analysis Pilot Test and Validation Research Study Julius Pham, Johns Hopkins Medicine Lead Investigator jpham3@jhmi.edu Carolyn Hoffman, Alberta Health Services Canadian Patient Safety Institute- Co-Lead Investigator Carolyn.hoffman2@albertahealthservices.ca Slide 25 World Health Organization, 2012 Background Building on: High 5s project - World Health Organization (WHO) Canadian Incident Analysis Framework - Canadian Patient Safety Institute Funding and in-kind contributions from: Canadian Patient Safety Institute In-kind contributions from WHO Johns Hopkins University Alberta Health Services Support: International Advisory Group Slide 26 World Health Organization, 2014 Concise Incident Analysis Overview Consistent with the principles and methodology of a comprehensive incident analysis Conscious and deliberate decision to focus primarily on four aspects: the facts, key contributing factors, actions for improvement (if any) and evaluation Slide 27 World Health Organization, 2012 Slide 28 World Health Organization, 2014 Concise Approach Most commonly for incidents or concerns that resulted in no or low harm to the patient. Conducted by expert Facilitator, who reviews report and seeks additional relevant information exploring key contributing factors through informal discussions with patients, family, provider, manager and/or expert(s), asking why and what influenced this determining if any evidence-based actions for improvement had been implemented and failed, and why were not effective in preventing determining if evidence-based actions may address the contributing factors Reviewing evidence-based actions for implementation Slide 29 World Health Organization, 2014 Constellation Map and Guiding Questions WHO. Concise incident analysis, draft methodology. Working Paper. October 2012 Slide 30 World Health Organization, 2014 Status Phase 1: pilot test concise incident analysis tool Finalize data analysis by May 2014 Summarize results, prepare and submit article for publication Outcome: finalize and publish standardized Tool Phase 2: validate tool May 2014-May 2015: Develop methodology, Recruit sites, Begin validation study Outcome: research methodology implemented in healthcare settings around the world to test the tool. Slide 31 World Health Organization, 2014 Methodology Participating Sites Australia Logan Hospital Gold Coast University Hospital Caboolture Hospital Canada Alberta Health Services Hong Kong Prince of Wales Hospital Queen Mary Hospital India Amrita Institute of Medical Sciences Indraprastha Apollo Hospitals United States Johns Hopkins Hospital Slide 32 Next areas of work Slide 33 World Health Organization, 2014 Protective, ethical and just environment Legal framework, with modalities of confidentiality, defining liabilities and responsibilities; Educational programs for different stakeholders to help them understand how reporting tools should be used. Healthcare professionals need to strengthen their skills of communication with patients, especially when adverse events have to be shared. Reporting systems as part of person's centered care and as patient's empowering mechanism Fundamental to develop clear mechanisms for learning and put in place prevention strategies Slide 34 Discussion Fit for purpose, relevance, gaps Slide 35 THANK YOU Itziar Larizgoitia, larizgoitiai@who.int