PROCESS STANDARD Bay of Plenty District Health Board (BOPDHB) is committed to ensuring a safety culture approach to incident management which is system focused, with the exception of reckless, wilful, unethical or criminal acts to minimise and / or prevent harm through timely, accurate, objective, standardised and co-ordinated reporting and management of all incidents, accidents and near misses. OBJECTIVE This protocol provides an integrated set of resources focused on the immediate and ongoing actions following patient and staff safety incidents (including near misses.) It aims to help those responsible for incident management respond to and reduce the harm to patients / families and staff when incidents do occur. This will be achieved by: All incidents are logged in the Incident Management System (Datix) when they occur or when they become apparent and given an initial Severity Assessment Code (SAC) by the reporter. All incidents likely to result in media attention will be escalated immediately to the Quality and and / or Risk, Health and Safety Manager as relevant. Open discussion of incidents that result in harm to a patient while receiving health care with the patient, their family, carers and other support persons. Ensuring all incidents are reviewed within expected timeframes Ensuring that recommendations, actions, contributory factors and learnings from the review are designed, implemented and evaluated to minimise the risk of recurrence of a similar incident and that these are documented in Incident Management System, BOPDHB s Incident Management System. Learnings are shared across the BOPDHB staff to prevent recurrence of incidents and accidents. STANDARDS TO BE MET 1. External Standards BOPDHB is required to meet the following external reporting requirements: 1.1 Events where patients suffer serious harm: All SAC 1 and 2 rated adverse events that meet the reporting criteria, plus events from the Always Report and Review list will be reported to the Health Quality and Safety Commission within 15 working days from the date the event is reported. Reports go to the Quality and Patient Safety in the first instance. 1.2 Events where employees, visitors or contractors suffer serious harm: Worksafe must be notified when certain work-related events (notifiable events) occur along with the Risk, Health and Safety. 1.3 Events where patients suffer serious harm e.g. as a result of manual handling or failure of equipment used in administering treatment Risk, Health and Safety report to Worksafe New Zealand. 1.4 Critical incidents occurring to consumers subject to the Mental Health Act are reported to the Director of Mental Health, Ministry of Health. 1.5 Unintended adverse reactions occurring in association with the use of medicines Page 1 of 7
PROCESS are reported to the Centre for Adverse Reactions Monitoring (CARM). 1.6 Events involving a medical device that has caused or could have caused an injury to the patient or device are reported to Medsafe, Ministry of Health. 1.7 Events involving the safety of electrical equipment are reported to Energy Safety Service, Ministry of Consumer Affairs. 1.8 Events involving fuel gas are reported to Energy Safety Service, Ministry of Consumer Affairs. 1.9 Events relating to the misadministration of radioactive materials are reported to National Radiation Laboratory. 1.10 Events involving explosives are reported to Dangerous Goods Inspector or equivalent. 1.11 Events occurring at Certified Healthcare Facilities involving death, serious harm or investigations commenced by Police are reported to Director-General of Health under Health and Disability Sector Safety Act. 1.12 In cases of serious misconduct the Police and / or professional registration bodies may be advised in accordance with appropriate legislation, at the discretion of BOPDHB or as required by the relevant legislation. 2. Roles And Responsibilities Incident management is everyone s responsibility within BOPDHB and therefore requires a whole of organisation approach. 2.1 All employees are responsible for a) Fostering an environment where appropriate incident identification and notification is encouraged. b) Notifying all incidents using the BOPDHB electronic incident management system. c) Supporting other staff with completion of incident documentation as appropriate. d) Working safely to minimise the occurrence of incidents. e) Participating in the reviews of incidents as required and discussion on prevention strategies and implementation of recommendations as required. f) Giving consideration to the need to log a risk or hazard in the incident management system e.g. if there have been several incidents of a similar nature 2.2 Specific responsibilities Specific roles may have individual responsibilities in relation to incident management. a) Ward / Team / Line Managers including Chief Operating Officer / Executive Director / Director / Service Nurse or Business Leader / Clinical Nurse Manager / Clinical Midwife Manager / Clinical Unit Leader, Clinical Directors are responsible for: i. Reviewing all incidents notified via the Incident Management System refer to Incident Management Process section below for timeframes ii. Completing the Incident Management System review processes as outlined in BOPDHB Incident Reviewers Quick Guide 2018; iii. Ensuring appropriate resources are available to support patient and staff safety iv. Supporting the serious adverse event process within their service v. Supporting access to education and training for employees on incident Page 2 of 7
PROCESS management, in particular use of the Incident Management System to log and manage incidents vi. Ensuring that any interventions and corrective actions have been implemented vii. Logging a risk in the risk register where the incident indicates an ongoing risk b) Chief Medical Advisor / Medical Director and Director of Nursing are responsible for: i. Reviewing all SAC 1 and 2 review reports to ensure appropriate reviews have been undertaken ii. Ensuring that appropriate clinical interventions and corrective actions have been implemented c) Chief Executive Officer (CEO) is responsible for: i. Ensuring an effective framework is in place for managing all incidents ii. Ensuring appropriate resources are available to support effective incident management and safety initiatives iii. Ensuring compliance with external / legislative reporting requirements iv. Ensuring reviews are conducted in accordance with this policy d) Quality and Patient Safety are responsible for: i. Monitoring reviews and closing clinical incidents when review is complete in the Incident Management System ii. Reviewing all SAC 1 and 2 clinical incident notifications to provide appropriate initiation and support to managers responsible for reviews and / or investigations iii. Monitoring the quality of individual serious adverse event reports, implementation of recommendations arising from serious adverse events iv. Recommending policies and strategies for improving quality and safety, as required v. Reporting trended incident data and outcomes of serious adverse events to relevant groups throughout the BOPDHB e.g. relevant committees, as required vi. Ensuring compliance with external reporting requirements vii. Providing feedback and disseminating lessons learned from internal and external incident management processes through regular and ad hoc reporting as required e) Risk, Health and Safety are responsible for: i. Reviewing and taking appropriate action on all notifiable incidents related to the workplace. ii. Monitoring reviews and closing staff incidents when review is complete in Datix, the Incident Management System. iii. Reviewing all risk, health and safety related SAC 1 and 2 incident notifications to external agencies and provide appropriate initiation and support regarding reviews iv. Overseeing the quality of reports and monitoring implementation of recommendations arising from health and safety serious adverse events v. Recommending policies and strategies for improving risk, health and safety as required vi. Reporting trended risk, health and safety incident data and outcomes of serious adverse events to relevant groups throughout the BOPDHB as required Page 3 of 7
PROCESS vii. Ensuring compliance with risk, health and safety external reporting requirements viii. Providing feedback and disseminating lessons learned from internal and external incident management processes through regular and ad hoc reporting as required 3. The Incident Management Process The incident management process (refer Appendix 1) is a continuous process that has many components: 3.1 Identification a) incidents may be identified from a variety of sources e.g. direct observation, complaints, coroner s reports, staff meetings, mortality review meetings. 3.2 Immediate Action a) mitigate the harmful consequences of the incident, i.e. support for the person(s) involved (patient / their family or staff, visitor, contractor), making the local environment safe, call for assistance and / or advice. b) In the event of serious harm to a staff member, where possible the scene of the incident should be secured by the person in charge of the workplace and notified accordingly to the Risk, Health and Safety Manager, Duty Nurse Manager (and / or Worksafe New Zealand after hours) 3.3 Open Disclosure and Communication BOPDHB supports open and timely discussion with the patient, family / whanau / carer of any adverse event occurring as a consequence of the provision of healthcare by BOPDHB employees: a) The health professional with the overall responsibility for the patient should make the disclosure of the harm to the patient and / or support person and ensure full documentation of the discussion in the clinical record. If the person who has the overall responsibility for the care of the patient is not the same practitioner who has provided the direct care to the patient then both practitioners should be present. Consideration should be given to the patient s cultural and language needs. b) Disclosure should be made to the patient and / or support person within 24 hours of the harm occurring or error being recognised. Disclosure is not a single conversation but an ongoing process. c) If the harm occurred in a team environment the team should meet prior to disclosure to discuss what happened, how it happened, consequences to the patient, how to avoid future occurrences and how to approach the matter with the patient and / or support person. d) After the patient and / or support person has been informed of the harm the team should hold a debrief session, details of the incident and any harm, the disclosure and subsequent action, which should be fully documented in the patient s health record. e) Where the harm is classified as a serious adverse event (excluding Mental Health & Addiction Services events), and a root cause analysis (RCA) is undertaken. The Quality and, or delegate, will be the key contact for the patient and / or support person and provide ongoing communication. Page 4 of 7
PROCESS 3.4 Notification a) The incident should be logged in the Incident Management System by the staff member involved as soon as possible or this may be done by any staff member who becomes aware of the incident. If unsure, advice may be sought from Quality and Patient Safety and / or Risk, Health and Safety. b) Where the incident has resulted in patient harm: i. An ACC 46 form must be completed and a treatment injury form ACC 2152 if appropriate ii. If the incident involves a staff member, student, visitor or contractor, medical attention should be sought as required, and the incident should be entered into the incident management system. Risk, Health and Safety will automatically be notified when the incident is saved iii. If needlestick / blood or body fluid incident then follow procedure in Bay of Plenty District Health Board policy 5.4.4 protocol 0 Blood and Body Fluid Exposure - Standards c) Where the incident requires review and response from another BOPDHB service, the line manager named in the incident management record is responsible for: i. Adding the required person to the review team and sending an email explaining what is required from team and the expected timeframe using the communication functions in the Incident Management System ii. Updating their own part of the review, any actions taken and adding progress notes where appropriate iii. Where the other person does not respond to the line manager s request for follow-up, the line manager may escalate this to their own manager. d) Where the incident involves an external facility e.g. rest home and is felt to be sufficiently serious to need follow up, it is the line manager s responsibility to contact the facility to notify them of the issue and to notify the relevant Portfolio Manager at BOPDHB Planning and Funding. e) Where the incident involves a community pharmacy, it is the line manager s responsibility to notify the relevant Portfolio Manager at BOPDHB Planning and Funding. 3.5 Protected disclosure: It is the BOPDHB s aim that internal processes will be maintained in accordance with the Protected Disclosures Act 2000. Staff are encouraged to have recourse to this Act after first utilising the internal procedure outlined in Policy 3.50.05 protocol 1 Protected Disclosures - Standards. 3.6 Prioritisation and review: a) Line Managers and / or their delegate are responsible for using the standardised process of confirming the actual Severity Assessment Criteria (SAC) score of the incident in the Incident Management System within expected timeframes (refer Appendix 1) to assist in the prioritisation and assessment of the level of review required. i. Some incidents require mandatory external notification and must be escalated to Quality and Patient Safety, or Risk, Health and Safety within one (1) working day, for further details see External Standards. ii. Different levels of incident review are required in accordance with the SAC score - refer Midland DHB Severity Assessment Code matrix in the Incident Management System, for further details see External Standards: SAC1 and 2 reviews must have their review completed within 70 Page 5 of 7
PROCESS working days SAC 3 and 4 incidents must be completed within 30 working days. b) Risk, Health and Safety monitor risk, health and safety related incidents and their review process, depending on the level of harm / risk, also refer to the Bay of Plenty District Health Board policy 5.3.1 Employee Health and Safety c) For SAC 1 and SAC 2 incidents, a team review approach will be taken for RCA facilitated as required by Quality and Patient Safety and / or Risk, Health and Safety. d) Mental Health and Addiction Services (MH&AS) review their own SAC1 and 2 events and report findings to Quality and Patient Safety. e) Risk, Health and Safety may carry out their own reviews of other incidents, as required f) Incidents involving reckless, unethical or criminal behaviour or involving a complaint or concern about a gross negligence of a staff member must be referred directly to the Chief Executive Officer, or delegate, and managed in accordance with current BOPDHB Human Resources policies. 3.7 Analysis and Action a) Results of all reviews must be analysed, and action identified to improve the quality of service delivery and to minimise the risk of recurrence of a similar incident. These actions are to be recorded in the Incident Management System incident, risk and / or complaints modules as appropriate and assigned to a responsible person to facilitate monitoring of achievement. 3.8 Feedback a) All staff can access incidents they have reported in the Incident Management System and have read only access to the review section. b) Timely feedback to staff will also assist in successful incident management via the implementation of improvements and mitigations. c) Feedback should be given to patients and / or family on the outcomes of the review and the actions taken to improve service delivery and reduce recurrence. d) Incident management must be included on the agenda of regular team meetings. Reports on aggregated and trended data, including outcomes from reviews and improvements, should be discussed. e) Good clinical practices or risk, health and safety practices identified through review should also be acknowledged during feedback. 3.9 Protection of Information a) Any external requests for information relating to an incident shall be forwarded to the Chief Executive Office for response. ASSOCIATED DOCUMENTS Bay of Plenty District Health Board policy 2.1.4 Incident Management Bay of Plenty District Health Board policy 5.4.4 protocol 0 Blood and Body Fluid Exposure - Standards Bay of Plenty District Health Board policy 2.5.1 Health Information Privacy Bay of Plenty District Health Board policy 5.3.1 Employee Health and Safety Bay of Plenty District Health Board policy 1.3.1 Complaints Management Bay of Plenty District Health Board policy 3.50.05 Protected Disclosures Bay of Plenty District Health Board policy 6.6.1 Death of a Patient Bay of Plenty District Health Board policy 1.4.4 Cultural Safety - Maori Bay of Plenty District Health Board Incident Management form Page 6 of 7
PROCESS Appendix 1 The Incident Management Process Incident occurs and appropriate immediate actions taken Open disclosure to patient / family if required If needlestick / body fluid incident follow Policy 5.4.4 Incident reported in Incident Management System (Datix) Datix auto-notification email is sent to Department and Line Manager and other relevant staff Confirmed as SAC 1 or 2 Notify Quality and Patient Safety and / or Risk, Health and Safety Manager immediately as relevant Initial SAC score to be confirmed by Line Manager, Datix approval status changed to Being reviewed Confirmed as SAC 3 or 4 Initial review remains the responsibility of the Line Manager as per usual process. RCA, London Protocol, Always Report and Review or Serious Adverse Event Investigation may be required at decision of Quality and Patient Safety and / or Risk, Health and Safety Manager as relevant Review completed, Datix approval status changed to Review Complete Final review monitored by Quality and Patient Safety and / or Risk, Health and Safety Review is responsibility of Line Manager and needs to focus on: What happened Why did it happen What needs to be done to prevent it happening again Progress notes, lessons learned and any required actions entered into Datix and shared as required Feedback: All Reporters can access all incidents they have reported in Datix to see review, actions and lessons learnt. Review meets BOPDHB expected standard Yes Review Complete Datix approval status changed to Closed NO Review not complete Datix approval status changed back to Being reviewed and notification sent to reviewer outlining expectation Page 7 of 7