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1 Why clinical risk is relevant to patient safety? Workshop on Clinical Risk Management and Management of Adverse Event Belgrade December 2013 Dott.ssa Lucia Guidotti Ministry of Health, Department of Quality General Directorate for Health Planning and Policy 1
2 Topics to be presented Introduction 1-Clinical Governance issues 2-Sentinel Events Monitoring System 3-Recommendations for healthcare workers 4-Training and educational programs 5- Safety in the Operating Room 6-Guidelines to communicate adverse events Conclusions 2
3 International referring documents Introduction: Luxembourg declaration on patient safety of 5 April 2005, Communication of 15 December 2008 from the Commission to the European Parliament and the Council on patient safety Resolution of 23 April 2009 on the proposal for a Council recommendation on patient safety, Council recommendation of 9 June 2009 on patient safety, Eurobarometer survey (No 327) on Patient Safety and Quality of Healthcare, published in April 2010, Report of the World Health Organisation (WHO) entitled Core components for infection prevention and control programmes, Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients rights in cross-border healthcare, Report of 13 November 2012 from the Commission to the Council on the basis of Member States' reports on the implementation of the Council 3 Recommendation (2009/C 151/01) on patient safety
4 Introduction: 2013/2022(INI) - 22/10/2013 The European Parliament adopted a resolution on the report from the Commission to the Council regarding the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections. In its resolution, Parliament recommended that issue of patient safety, and in particular the prevention and control of HAIs, should be given a place near the top of the political agenda in the EU, both at national level in the Member States and at regional and local level. 4
5 1- Clinical Governance issues Patient safety and Risk management Protocols and Clinical Guidelines Stakeholder involvement Professional integration also across different disciplines Complaints Communication Audit and Feedback Evidence based medicine Evidence based health care Continuing Education and training Medical, legal and insurance aspects 5
6 1- Clinical Governance issues Several activities to improve quality and patient safety Use of clinical guidelines Clinical Leadership Clinical Audit Clinical Risk Management Patient Safety Evidence based practice Continuing Professional Development Performance Management Research and Patient and staff involvement Development Reflective Practice Complaints Management Service improvement 6
7 2- Sentinel Events Monitoring System Sentinel Event n Adverse Event n Near misses Sentinel Event 8
8 Ministero dellasalute 2- Sentinel Events Monitoring System Sentinel Event definition unexpected adverse event, potentially avoidable that leads or may lead to death or serious physical/psychological injury and needs immediate investigation to analyse all contributing and causing factors and identification of the strategies that the organization intends to implement in order to reduce the risk of similar events 9
9 Ministero dellasalute 2- Sentinel Events Monitoring System The Ministry of Health developed an alert system for clinical and care conditions at a higher risk of error, with the objective to warn healthcare workers of certain potentially dangerous procedures, to provide effective tools to reduce the risks and promote healthcare worker responsibility in order to favour the system changes. 10
10 2- Sentinel Events Monitoring System How it works The adverse events, processed in anonymous and confidential way, are forwarded to the National Health Information System throught a specific flow called Information System Monitoring Errors (SIMES) web based. The Ministry of Health has a National Observatory about sentinel events at Department of Quality Public hospital 11
11 2- Sentinel Events Monitoring System Analize a Sentinel Event happened in Italy in 2011 Due to a 10 fold anticancer drug therapy a young woman died 12
12 2- Sentinel Events Monitoring System SIMES - Organizations involved in the process Local Regional National Organizations involved in this process are: Ministry of Health Regions and Autonomous Provinces Hospitals and Health facilities Validation is an evaluation process about data by Local Level, Regions and Ministry of Health 13
13 2- Sentinel Events Monitoring System Sentinel Events Monitoring Protocol is used until september 2005 in an experimental way, while from December 2009 it is defined by a Ministerial Decree. Two forms: FORM A: - Health facility - Referent - Type of Sentinel Event - Patient Data - Outcome FORM B - Description - Analizing Method - Reasons and causes List - Risk Reductin Actions 14
14 2- Monitoring Sentinel Events System Ministerial Decree 11 Dec 2009 Information System Monitoring Errors (SIMES) Establishment Clinical risk manager, where available, or a person identified by hospital management, fills out Form A, sends it to region, at the time of the event or to the knowledge of it; Clinical risk manager, fills out Form B, sends it to the Ministry within 45 calendar days from the validation (these are the same times adopted in other Countries) 15
15 2- Monitoring Sentinel Events System Sentinel Events List 1. Procedure performed on wrong patient 2. Procedure performed on wrong body part (side, organ or part) 3. Wrong procedure performed on correct patient 4. Retention of instruments or other foreign object during surgery requiring another or successive surgery or procedure performed to rectify error 5. Transfusion reaction consequent to AB0 incompatibility 6. Death, coma or severe functional alterations derived from error in pharmacological therapy 7. Maternal death or illness correlated to labour and/or childbirth 8. Death or permanent disability in healthy newborn weighing > 2500 grams not correlated to a congenital illness 16
16 2- Monitoring Sentinel Events System Sentinel Events List 9. Death or severe injury due to patient fall 10. Patient suicide or attempted suicide in a hospital 11. Violence to hospitalized patient 12. Violence against healthcare professionals 13. Death or severe harm due to a malfunction of the transport system (intrahospital, extrahospital) 14. Death or severe injury due to an incorrect attribution of a triage code by the Central Operative unit 118 and/or in the Emergency Ward/ First Aid 15. Unexpected Death and/or Severe Harm Consequent to a Surgical Procedure 16. Every other adverse event that causes death or severe injury 17
17 2- Monitoring Sentinel Events System 1918 reports collected and valid. The most frequently signalled Death or severe injury due to patient falls: 24,56%. Mortality rate: 35,6%. In a percentage of 39,26%, Sentinel Events happened inside patient rooms 18,72% in the operating room. 18
18 Death or severe injury due to patient fall % Patient suicide or attempt suicide in Hospital % Any other AD that causes Death or severe injury % Acts of violence on heath care workers % Retention of instruments requiring another procedure % Unexpected death or severe harm consequent to a surgical procedure % Death or disability in healty newborn weighing>2500gr % Death or harm due to pharmacological terapy error % Transfusion reaction due to AB0 incompatibility % Maternal death or illness due to labour % Wrong procedure performed on right patient % Death or severe injury due to wrong attribuiton of Triage Code % Procedure performed on wrong body part (side, organ) % Procedure performed on wrong patient % Death or severe injury due to transport system (intra/extra hospital) % Violent act to hospitalized patient % total % 19
19 Previous Report 20
20 2- Monitoring Sentinel Events System Monitoring Learning from error Identification, evaluation of current and possible risks and management Recommendations Put into practice safety solutions Continuous Professional Development Enhancing patient safety Improving knowledge on safety culture among health professionals 21
21 Protocol Sentinel Events Data collection and analysis Monitoring and Evaluation Solutions 22
22 3-Recommendations for healthcare workers Ministry of Health in collaboration with experts from Regions drafted and diffused the Recommendations in order to offer healthcare workers information about dangerous conditions causing severe or fatal consequences to patients. These recommendations increase knowledge about dangerous events and show actions to prevent sentinel events. MoH recommendations in many cases, follow sentinel events. 23
23 24
24 3-Recommendations for healthcare workers Ministry of Health pubished 15 Recommandations: Death or severe injury due to wrong attribution of code in the Emergency Unit Preventing errors in anticancer drug therapy Preventing patient fall in health facilities Preventing therapy errors using drugs Look-alike/sound-alike Death or severe injury due to a malfunction about transport system iside or outside hospital Recommendation for the prevention of bisphosphonate associated osteonecrosis of the jaw/ mandibular bone Recommendation for the prevention of adverse events consequent to the malfunction of medical devices and electromedical instruments Recommendation to prevent acts of violence to healthcare workers Recommendation for the prevention of death, coma or severe bodily harm originating from an error in pharmacological therapy 25
25 3-Recommendations for healthcare workers Recommendation for the prevention of maternal death correlated to childbirth and/or labour Recommendation for the prevention of a transfusional reaction due to ABO incompatability Recommendation for suicide prevention of hospital patients Recommendation for the correct identification of patients, surgical site and procedure Recommendation to prevent the retention of gauze, instruments or other material in a surgical site Recommendation for the correct use of concentrated solution containing Potassium Cloride KCL- and other concentrated solutions containing Potassium 26
26 4-Training and educational programs The number of action plans sent by health facilities compared with all sentinel events signalled is 55,1%. previous report 40,5% To improve this data, Ministry of Health has published the Root Cause Analysis Handbook and the Clinical Audit Handbook, available on Ministry of Health Web site FAD courses (on line courses) METODI DI ANALISI PER LA GESTIONE DEL RISCHIO CLINICO Root Cause Analysis - RCA Analisi delle Cause Profonde L AUDIT CLINICO Settembre 2009 Maggio
27 4- Training and educational programs Safety in surgery Ministry of Health has developed a specific handbook about Safety in Operating Room with Italian version of Checklist for Safe Surgery, based on WHO proposal. Ministry of Health made two videos illustrating the methods to avoid risk. These videos show how to use or not to use checklist, it is available on web site 28
28 5-Safety in the Operating Room surgical procedures are complex for number of professional people involved, acute conditions of patients, amount of information required, the urgency, the high technological level communication processes within the team operating: the surgeon, the anesthetist and the nurse are not working in isolation ensure a climate of collaboration between different professionals. 31
29 5-Safety in the Operating Room Ministry adapted WHO checklist for safety in the operating room, adding another item to the 19 concerning prophylaxis of venous thromboembolism. The checklist includes 3 phases (Sign In, Time Out, Sign Out), 20 items to be performed and to mark after successful control 32
30 33
31 34
32 6-Guidelines to communicate adverse events A guideline to manage and communicate adverse events has been produced, to define an operative and effective process about what happened, also with the aim of ensure a clear and open communication. 35
33 6-Guidelines to communicate adverse events This guideline contains the following recommendations: Adverse event analysis Adverse event patient communication Actions to heathcare professionals involved in an adverse event External Communication in Adverse Events conditions happened in Health Facilities 36
34 Concluding remarks Why clinical risk is relevant to patient safety? Due to the high complexity of health systems, it is important to implement activities on different topics, and implement a continuous and constant updating of health professionals involved. SEs represent a lack in health care process: ensure quality and safety of care for patients and health professionals producing useful documents. 37
35 Concluding remarks Why clinical risk is relevant to patient safety? AE Reporting system is essential to increase awareness of the causes and factors to collect information on severe and potentially avoidable adverse events 38
36 Thank you for your attention 39
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