Policy no: RM04 Version: 6.1 Name of policy: Incident/near-miss reporting and investigation policy (includes Serious Incidents) Effective from: 28/01/2013 Date ratified 20/07/2012 Ratified PQRS Committee Review date 01/07/2014 Sponsor Director of Nursing, Midwifery & Quality Expiry date 19/07/2015 Withdrawn date This policy supersedes all previous issues Incident/near miss reporting and investigation policy (including serious incidents) v6.1
Version control Version Release 1.0 December 1998 Author/ reviewer Ratified by / Authorised by Trust Policy Forum Date 09/12/1998 Changes (Please identify page no.) 2.0 May 2002 Trust Policy Forum 3.0 February Risk 2003 Management Committee Clinical Improvement Group 08/05/2002 February 2003 4.0 November 2006 Clinical Improvement Group November 2006 5.0 January 2009 Head of Corporate Risk PQRS January 2009 5.1 30/09/2009 Risk Facilitator September 2009 5.2 30/09/2009 Risk Facilitator PQRS January 2009 5.3 24/02/2011 H&S Risk and Director of January Assurance Estates & 2011 Manager Risk 6.0 29/08/2012 Risk Management Facilitator/ Head of Compliance 6.1 28/01/2013 Risk Management Facilitator Management PQRS 20/07/2012 Head of Nursing, Midwifery and Quality 25/01/2013 Formatted to OP27 policy on development, management and authorisation of policies Minor revision to Appendix C Amendment to risk matrix as agreed at PQRS Incident/near miss reporting and investigation policy (including serious incidents) v6.1 2
Incident/near-miss reporting and investigation policy (includes serious incidents) Contents 1. Introduction... 4 2. Policy scope... 4 3. Aim of policy... 4 4. Duties roles and responsibilities... 4 5. Definitions... 6 6. Incident/near miss reporting and investigation process... 9 6.1 How to report an incident including timescales... 9 6.2 Review and investigation of incidents... 11 6.3 Levels of investigation... 13 6.4 Serious incidents and Never events... 14 6.5 Re-grading of incidents... 14 6.6 Organisational learning... 14 6.7 Raising concerns... 14 6.8 RM67 Supporting staff involved in an incident, complaint or claim... 14 6.9 Involving patients and their families in investigations... 15 7. Training... 15 8. Equality and diversity... 15 9. Monitoring compliance with the policy... 16 10. Consultation and review... 16 11. Implementation of the policy... 16 12. References... 16 13 Associated documentation... 17 Appendices Appendix 1 Flowchart: Process for the reporting and management of incidents... 18 Appendix 2 Serious incidents and Never events definitions and procedures... 19 Appendix 3 Flowchart: Process for the management and reporting of Serious Incidents... 24 Appendix 4 Incident grading matrix... 25 Appendix 5 Levels of harm/actual severity... 28 Appendix 6 Guidance for notifying external agencies... 29 Appendix 7 Guidance for Root Cause Analysis... 32 Appendix 8 Three levels of RCA investigations guidance... 36 RCA Investigations report... 37 Appendix 9 Guidance for writing statements... 42 Appendix 10 Guidance for interviews... 46 Appendix 11 Hotline arrangements... 47 Appendix 12 Serious Incident Reporting Panel (SIRP) Terms of Reference... 48 Incident/near miss reporting and investigation policy (including serious incidents) v6.1 3
1. Introduction GATESHEAD HEALTH NHS FOUNDATION TRUST Incident/near-miss reporting and investigation policy including serious incidents (Sis) Gateshead Health NHS Foundation Trust recognises that in a service as large and complex as the NHS things can go wrong. It actively supports the promotion of a positive and fair blame approach to incidents and near miss reporting in a culture of openness and learning which is fundamental to effective risk management. The Trust supports the view that the response to incidents should not be one of blame but of organisational learning to encourage participation in the overall process The Trust is committed to developing a just culture, encouraging a willingness to admit mistakes without fear of punitive measures. The completion of an incident report does not constitute an admission of liability. The Trust believes that incident investigation and reporting should only trigger or contribute to any disciplinary procedure where there is a criminal act or where a member of staff has wilfully and/or negligently, exceeded their professional boundaries. The recommendations of the Department of Health publications An Organisation with Memory 1, Building a Safer NHS 2, Doing Less Harm 3, National Patient Safety Agency publication Building a memory: preventing harm, reducing risks and improving patient safety 4 and Safety First 5 and the Health and Safety at Work Act 1974 have been taken into account in the development of this policy. We will make sure that we share the learning from incidents both internally and externally where appropriate and possible. 2. Policy scope This policy applies to all staff working within the Trust, all patients treated and all visitors, contractors, volunteers and members of the public visiting the premises. 3. Aim of policy This policy outlines how the Trust will report, manage, analyse and learn from all clinical and non-clinical incidents, near misses and Serious Incidents (SI s) to reduce the risk of harm to patients, staff and other users of Trust premises through improving safety, quality of services and the environment by providing an effective incident reporting and investigation system. 4. Duties - roles and responsibilities Trust Board Trust Board has overall responsibility for effective risk management, the safety of patients, staff and visitors within the Trust and to ensure the Trust complies with its statutory obligations. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 4
Chief Executive The Chief Executive has ultimate responsibility for safe care, including risk management, but delegates this responsibility to the Director of Nursing, Midwifery and Quality and the Medical Director. The Chief Executive will chair any Serious Incident Review panels and ensure external reporting of serious incidents where appropriate. Head of Risk Management The Head of Risk Management is responsible for the development, implementation and maintenance of a robust Trust-wide incident reporting and investigation system. The Head of Risk Management will manage the Serious Incident Reporting Procedure and is the nominated officer for SI reporting through the South of Tyne & Wear Primary Care Trust, coordinating the collection of information required to submit initial and final reports. Datix Team The Datix team comprising the Datix System Manager and Secretary/Assistant Datix Administrator manage the Datix incident reporting module being the focal point for all incident reports, training, access to and management of the system. Investigators: Investigators are identified within the Datix system dependent on the nature and location of the incident. Investigators are responsible for investigating incidents fully in accordance with this policy including the development and follow up of action plans. Specialist Advisers Specialist advisers e.g. Information Governance Officer, Medical Devices Manager, Health and Safety Manager/Adviser are automatically notified of specific incidents within their sphere of knowledge. They are responsible for reviewing the incident and either giving advice about the investigation of the incident or investigating and reporting on it themselves depending on the level of harm/level of risk. The will be responsible for any external reporting necessary (see appendix 6) Health & Safety Manager/Health & Safety Adviser The Health & Safety Manager or Adviser is responsible for overseeing that all Health & Safety incidents are investigated and RIDDOR reportable incidents are investigated fully and reported within the Health and Safety Executive timescales. Divisional managers Divisional managers are responsible for promoting effective risk management, ensuring operational systems are in place to meet the requirements of this policy. They have a responsibility to make sure that all incidents within their division are reported in accordance with this policy and that serious incidents are reported to the Head of Risk Management who will coordinate the reporting to the Chief Executive or Director on Call in normal working hours or the ART night site manager out of hours. Divisional risk managers/risk representatives Are responsible for the effective and efficient management of the incident reporting process within their division including making sure that the appropriate levels of Incident/near miss reporting and investigation policy (including serious incidents) v6.1 5
investigation are completed and incidents and action plans (where appropriate) are signed off in a timely manner. Acute Response Team (ART) night site manager The ART night site manager may receive reports of serious incidents and will ensure that the necessary arrangements are in place to ensure the immediate safety of the patient and individuals involved, the quarantining of equipment and notifications required at that time. The ART night site manager will notify the senior nurse on call of any such incidents. Senior nurse on call The senior nurse on call may receive reports of serious incidents and will ensure that the necessary arrangements are in place to ensure the immediate safety of the patient and individuals involved, the quarantining of equipment and notifications required at that time. He/she will ensure that the incident and actions taken are reported to the Head of Risk Management as soon as possible for the on-going coordination of the Serious Incident process. All managers Managers are responsible for promoting effective risk management, ensuring operational systems are in place to meet the requirements of this policy. This includes making sure that incidents (including near misses) are investigated in accordance with this policy. In addition, they have a responsibility to make sure that their staff receive appropriate risk management training by attending induction, mandatory training and other appropriate ad hoc training. All staff All staff should be aware of what is an incident, near miss or serious incident and the process for reporting and management of such incidents as part of their own accountability to safe care, reporting incidents as they arise. Patient Quality, Risk and Safety Committee (PQRS) The roles and responsibilities of the PQRS committee are included within the Terms of Reference attached in RM01 Risk Management Strategy. The PQRS is the committee with overarching responsibility for risk management (excluding financial risk). SI Review Panel (SIRP) The panel co-ordinates the investigation and reporting of serious incidents and nearmisses and ensures organisational lessons are learnt where relevant and that appropriate external reporting in completed. The Terms of Reference of the SIRP are attached at appendix 12. Risk Management (Complaint, litigation, incidents, & PALS) Group The aim of the Risk Management (CLIPA) Group is to ensure that the Trust has an integrated approach to the management and investigation of complaints, claims, incidents and issues reported to the Patient Advice and Liaison (PALS) service including learning and sharing lessons as appropriate. 5. Definitions Abuse, violent, disruptive or self harming behaviour: Untoward events that cannot be reasonably said to be accidental in motive and include physical assaults by any person, deliberate self harm, aggressive incidents and other incidents Incident/near miss reporting and investigation policy (including serious incidents) v6.1 6
involving verbal abuse, sexual or racial harassment, or intimidation or threatening behaviour. These may be face to face or over the telephone. Clinical incident: A clinical incident is one which arises in the context of the duty of care owed to patients by members of the healthcare professions (including medical/dental practitioners, nurses and midwives, professions allied to medicine, laboratory staff and relevant technicians) or by others consequent on decisions or judgements made by those professions in their professional capacity or relevant work e.g. misdiagnosis, incorrect site surgery, failure to act upon test results. Causal factors/root causes: The prime reason(s) why an incident occurred. A root cause is a fundamental contributory factor. Removal of these will either prevent, or reduce the chances of a similar type of incident from happening in similar circumstances in the future. Contributory factors/associated factors: Contributory factors are those which affect the performance of individuals whose actions may have an effect on the delivery of safe and effective care to patients and hence the likelihood of Care Delivery Problems (CDP) or Service Delivery Problems (SDP) occurring. Contributory factors may be considered to either influence the occurrence or outcome of an incident, or to actually cause it. Generally speaking the removal of the influence may not always prevent incident recurrence but will generally improve the safety of the care system; whereas removal of causal factors or root causes will be expected to prevent or significantly reduce the chances of recurrence. Fire incident: Any incident that involves actual smoke/fire or suspected smoke/fire or fire alarm. Harm: Harm is defined as injury, suffering, disability or death. (See appendix 6 for levels of harm) Incident: an event or circumstances involving patients, visitors or staff that could have or did lead to unintended or unexpected harm, loss or damage. This harm can be identified as physical or psychological. Information Governance Serious Incident: Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious. (This applies irrespective of the media involved and includes both loss of electronic media and paper records). Infrastructure/resources incident: Any incident/near-miss that is believed to be due to inappropriate staffing/ facilities or environment should be reported in this category. Investigator: A person identified within the Datix system responsible for investigating incidents in accordance with this policy Medical device/equipment incident: Any incident or near miss involving medical device/equipment including lack of availability or equipment failure should be reported in this category. Medication incident: Errors/near-misses in the prescribing, dispensing, administration or recording of medications should be reported using this category. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 7
Near miss: a situation in which an event or omission, or a sequence of events or omissions, fails to develop further, whether or not as a result of compensating action, thus preventing injury to a patient, visitor or member of staff. Negligence: Conduct that falls below the standards of behaviour established by law for the protection of others against unreasonable risk of harm. A person has acted negligently if he or she has departed from the conduct expected of a reasonably prudent person acting under similar circumstances. Never events: Never events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. These are updated on an annual basis by the National Patient Safety Agency (NPSA). The up to date schedule of Never Events is attached to the Datix incident reporting system. Non-patient personal accident (staff/visitor/contractor): Non-patient personal accidents are accidental untoward events which affect/involve a person or persons (other than a patient) and either resulted or could have resulted in injury. Patient personal accident: Patient personal accidents are accidental untoward events which affect/ involve a patient and either resulted or could have resulted in injury e.g. slips, trips and falls. Security incident: A security incident is one in which there is fraud, theft, deception, criminal damage, car crime, including all property belonging to the Trust. Patients absconding from the Trust or becoming missing are also included in this category. Specialist adviser: Advisers within the Trust who have specialist knowledge in relation to specific incidents e.g. Fire Officer to offer advice and/or externally report the incident. Reporter: Any person who reports an incident through the Datix incident reporting module. RIDDOR reportable incidents: It is a statutory requirement that all RIDDOR (Reporting of injuries, diseases and dangerous occurrences regulations) reports are submitted to the Health and Safety Executive (HSE) within15 days of the event. An incident is RIDDOR reportable if: An accident connected with work results in death or major injury; A member of the public is killed or taken to hospital; An accident connected with work results in an injury which requires more than 7 consecutive days absence from work; Work related disease; or Dangerous occurrence The Trust is required to keep a record of an incident if a worker has been incapacitated for more than three consecutive days. Root Cause Analysis (RCA): the process by which the underlying cause(s) of an incident are established. This is often a multi disciplinary meeting of the individuals Incident/near miss reporting and investigation policy (including serious incidents) v6.1 8
who were involved, chaired by an individual who was not involved in the incident. It can also be a comprehensive investigation using the principles and tools e.g. timeline of root cause analysis by one or more people. Any recommendations made arising from a RCA must be detailed within an action plan, followed up and signed off by the investigator. Security Incident Reporting System (SIRS) : From April 2010 NHS Security Management Service introduced a Security Incident Reporting System. This was developed to provide a clearer picture of security incidents across the health service in England, locally and nationally. This is a key step towards building a safer NHS where people and property are better protected. SIRS will be available from 1 st April 2010 to coincide with the extended requirements for reporting to the NHS Security Management Service. Therefore, the following security incidents will be reported using SIRS when the system is compatible with Datix.: any security incident involving physical assault of NHS staff; non-physical assault of NHS staff (including verbal abuse, attempted assaults and harassment); theft of or criminal damage (including burglary, arson, and vandalism) to NHS property or equipment (including equipment issued to staff); theft of or criminal damage to staff or patient personal property; and property damage arising from these types of security incident. Currently incidents of violence and aggression to staff are reported to NHS Protect. Serious Incident (SI): An incident or near miss occurring on health service premises or in relation to health services provided, resulting in death, serious injury or harm to patients, staff or the public, significant loss or damage to property or the environment or otherwise likely to be significant public concern. This shall include near misses or low impact incidents which have the potential to contribute to serious harm. The definition also applies to any incident involving the actual or potential loss of personal information that could lead to identity fraud or have significant impact on individuals. The up to date guidance on Serious Incidents and Never events is attached to the Datix incident reporting system. Wilful: intentional; deliberate 6. Incident/near miss reporting and investigation process 6.1 How to report an incident including timescales (see also flowchart at appendix 1) When a member of staff witnesses an incident they should: Take all necessary action to attend to the needs of the person(s) affected by the incident and minimise the risk of further harm. Where an item of equipment is involved, label and quarantine the item (documenting asset, batch, lot) and retain all evidence where possible. Where the level of harm is moderate, severe or death and could, therefore, constitute a Serious Incident must be reported verbally (by Incident/near miss reporting and investigation policy (including serious incidents) v6.1 9
the reporter) to the person in charge/senior manager or the nominated investigator for immediate action. That person will initiate the Serious Incident process. (Appendix 2) Complete a web based Datix incident report form which is accessed through the staff intranet under Info Services immediately if possible, but within a period of 24 hours from the time of witnessing the event. However, where there are exceptional circumstances incidents can be reported out-with this timescale rather than not being reported at all. (NB within domestic services and catering services a paper Datix form is completed by the member of staff then input into the electronic Datix system by the managers. The signed paper copy of the Datix form is filed in the department) When completing the Datix incident report form the reporter should: include only facts (not opinion) Write in sentence case in free text boxes not write in block capitals as this affects the national reporting No names or personal information of either staff or patients to be included in the free text boxes this information should be included in the contacts section. Again this affects the national reporting Nominate an investigator this would normally be the ward or department manager. See screenshot below If the incident involves a doctor in training the Additional investigator field as shown in the screenshot below must be completed. This is to inform the Clinical Skills Education Team, the Medical Director and the Lead Clinical Tutor of any incidents involving medical trainees so that the trainee s supervisor has a timely meeting with them to discuss the learning points and also to inform the revalidation process. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 10
6.2 Review and investigation of incidents When an investigator (as identified by the reporter) receives notification of an incident they must open and review the incident. Any moderate or serious harm incidents should be opened within 48 hours (see also reporting of serious a death incidents to the National Reporting and Learning Service (NRLS) below) with no harm, low harm and moderate harm within 5 calendar days to: o Confirm that the correct investigator has been identified. See authorised levels of investigation below. If not, it is the responsibility of the nominated investigator to redirect the incident to the correct investigator using the feedback fields i.e. o The investigator will review the details of the incident including the accuracy of the level of harm and all other coding making amendments if necessary. The investigator will also assess and enter the risk grading. o Where an incident is identified as a Serious Incident (potentially severe harm/death or high risk on the risk grading matrix and/or defined as a Serious Incident appendix 2 or a Never event see appendix 2) they must be reported immediately to the divisional manager or department head or nominated deputy and Head of Risk Management (ART night site manager out of hours) who then informs the relevant executive director or (senior nurse out of hours). It is the responsibility of the executive director to inform the Chief Executive. The divisional director should be informed at the earliest opportunity. The procedure for Serious Incidents (appendix 2) will then be initiated. o The investigator will identify the level of investigation required for the incident. (Where the incident is a Serious Incident the Serious Incident Reporting Procedure will be implemented as above) Incident/near miss reporting and investigation policy (including serious incidents) v6.1 11
Actual severity No harm or low harm Moderate harm Severe or death (SIs) Near miss no harm incidents Risk grading Very low risk and low risk Moderate risk High risk Investigator/final approver Ward/ department manager At the discretion of the Divisional Manager dependant on the divisional structure. See Datix documentation At the discretion of the Divisional Manager dependant on the divisional structure. See Datix Level of investigation See further guidance in 6.3 below Brief review Concise investigation* Comprehensive* investigation Opened within 5 calendar days Timescales Final approval Within 14 working days 48 hours 28 working days 24 hours 28 working days documentation The risk grading of near miss incidents may identify potential significant risks to the organisation and consideration should be given to carrying out either a concise or comprehensive investigation where this is the case Ward/ department manager At the discretion of the Divisional Manager dependant on the divisional structure. See Datix documentation At the discretion of the Divisional Manager dependant on the divisional structure. See Datix Brief review Concise investigation* Comprehensive investigation* Will have been opened according to level of harm above 14 working days 28 working days 28 working days documentation All individual CDiff, MSSA, MRSA, bacteraemia incidents require an RCA within 7 days Pressure damage RCAs in accordance with South of Tyne & Wear Serious Incident policy All medication errors to have a Medication RCA form completed (SI s to be dealt with through the SI procedure) *Any serious incidents as reported to the Commissioners must be completed on the NPSA template Certain incidents are notified to specialist advisers e.g. health & safety advisor, tissue viability nurse, Information Governance Officer automatically through the electronic incident system depending on the coding. Every incident notified to specialist advisers will be reviewed by them within 5 calendar days of notification. Where an incident involves another organisation e.g. ambulance service that services should be involved in the investigation and the commissioners informed of the incident by the Divisional Manager. For Information Governance incidents and incidents in the National Screening Programmes the specialist advisers will be involved in ensuring that the national guidance is implemented where necessary. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 12
Following investigation the investigator will attach all relevant documentation to the Datix incident report, give final approval, ensure completion of the action plan within the agreed timescale and give feedback on the outcome to the reporter of the incident. If there are any action which cannot be completed for any reason e.g. finance, cross divisional priorities, include the issue on the risk register. External reporting National Patient Safety Agency (NPSA) All patient safety incidents are reported to the NPSA through the NRLS. The NRLS and CQC statutory reporting requirements require that incidents graded death or severe harm must be reported to the NRLS within two working days (48 hours) of the incident occurring. Reporting of incidents to the NRLS and CQC should not be delayed by local investigation procedures. Grading of incidents can be changed if necessary following the completion of local investigations. There are specific requirements for external notification of a variety of incidents for example incidents relating to blood transfusions, information governance incidents, screening incidents. The requirements for external notification are detailed on appendix 6. 6.3 Levels of investigation The table in paragraph 6.2 above identifies the various levels of investigations required and timescales dependent on the severity or risk grading of incidents. The description of the investigations can be classed as: Investigation Brief review Concise investigation Comprehensive investigation Actual level of harm No harm/low harm/ very low risk/low risk Moderate harm/moderate risk Severe/death/high risk Notes A brief review of the incident to check the accuracy of the information, actions taken, applying the risk grading and whether any more detailed investigation is required. Can be finally approved if no further action required. Detailed investigations including either: o Multi-disciplinary RCA meeting which involves all of the people involved in the incident gathering to review the incident using the RCA tools to identify the contributory factors, root causes and develop an action plan for implementation and follow up o The investigator (possibly with support) carrying out a root cause analysis using the relevant RCA tools to identify the contributory factors, root causes and develop an action plan for implementation and follow up (See appendix 8 for RCA guidance) Incident/near miss reporting and investigation policy (including serious incidents) v6.1 13
Individual staff interviews may be necessary during an investigation: please refer to appendix 10. 6.4 Serious incidents and never events Serious incidents and never events will be reported and investigated in accordance with the Serious Incident procedure as detailed within appendix 2. 6.5 Re-grading of incidents If appropriate, the investigator or staff of the Risk Management Department may re-grade the incident (either in terms of level of harm or risk grading) as further facts and issues emerge during an investigation. Alterations must be initialled and reporter informed of change to grade. 6.6 Organisational learning To achieve organisational learning from incidents and near misses, CLIPA reports identifying numbers, location and trends (including SI investigations) are provided to the Safecare Council, Patient Quality & Risk Committee and the Council of Governors. Lessons learned are shared at Divisional Safecare meetings, Trust wide Safecare events and included in publications e.g. Safecare Alerts and Good Practice Bulletins. See also RM51 Learning from experience In addition the Trust reports all incidents reported via Datix to the National Patient Safety Agency via the National Reporting and Learning System and serious unexpected incidents to the Primary Care Trust via STEIS (Strategic Executive Information Service). Relevant reporting to the Care Quality Commission is achieved through the NRLS/NPSA system. The Trust also notifies other external agencies as identified in the Guidance for Notifying External Agencies (see appendix 6). Reports to analyse trends etc. can be provided to any group/committee/ department upon request. 6.7 Raising concerns Sometimes staff may find it difficult to report an incident/near miss perhaps due to the sensitive nature of the circumstances in which the incident happened. In these situations members of staff are encouraged to refer to PP35 Raising concerns at work policy and follow the reporting routes outlined within the policy. 6.8 RM67 Supporting staff involved in traumatic/stressful incidents Whether or not a member of staff feels personally culpable for any events surrounding an adverse incident the possibility of blame or criticism, whether public or private, is extremely stressful. Involvement at any level in an adverse incident gives rise to substantial anxiety. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 14
RM67 Policy for supporting staff involved in an incident, complaint or claim gives detailed guidance. The guidance only relates to providing staff support and does not replace, supersede or involve personnel guidelines or professional responsibilities, circumstances in which there may be disciplinary action, issues relating to patient protection or internal enquiries. 6.9 Involving patients and their families in investigations - Being open 7. Training The level of patient/family involvement clearly depends on the nature of the incident and the patient or family s wish to be involved. Unless there are specific indications to the contrary or the patient/their family requests other arrangements, these issues should be covered in a series of ongoing open discussion. The Trust fully supports the Being open principles of openness, honesty and transparency and the policy RM49 Being open gives information on the processes involving the patient and their family. 7.1 Training on the requirements of this policy will form part of the Trust s mandatory Training Needs Analysis. 7.2 Root Cause Analysis (RCA) Training There is an ongoing programme of Root Cause Analysis training for those staff members expected to investigate incidents and near misses. This training consists of a one day programme based on the NPSA Root Cause Analysis methodology. The objectives of the course are to: Increase the understanding of the theory underpinning RCA Provide candidates with an overview of the RCA process Provide skills in some of the RCA Tools Demonstrate the advantages of using a systems based approach to patient safety incidents 7.3 Datix training Training on the use of the Datix incident reporting module will be provided to investigators prior to gaining access to the system. 8. Equality and diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on the grounds of any protected characteristic (Equality Act 2010). An equality analysis has been undertaken for this policy, in accordance with the Equality Act (2010). Incident/near miss reporting and investigation policy (including serious incidents) v6.1 15
9. Process for monitoring compliance with this policy Monitoring compliance with this policy will be carried out as follows: Standard/process/issue All incident reporting Non clinical incidents and near misses Levels of investigation and process for following up relevant action plans Reporting to external agencies Monitoring and audit Method By Committee Frequency Quarterly summarised Head of Risk Risk Quarterly incident reports will be Management Management produced in the form of a (CLIPA) Group/ CLIPA report SafeCare Council/PQRS Any resulting action plans will be monitored by the Risk Management (CLIPA) Group Trends will be highlighted within the reports and the Committee will take responsibility for initiating actions to address these trends. Any resulting action plans will be monitored by the Health & Safety Committee Audit of compliance with different levels of investigation appropriate to the level of severity of the event(s) and process for following up action plans Any resulting action plans will be monitored by the PQRS Audit of compliance with the external reporting requirements Any resulting action plans will be monitored by the PQRS Health & Safety Adviser Head of Risk Management Head of Risk Management Health & Safety Committee PQRS PQRS 4 monthly Annual Annual In addition, The Risk Management (CLIPA) Group will monitor and analyse incident reporting trends, subsequent investigations and root cause analysis as outlined within the Risk Management (CLIPA) Group terms of reference and as described in policy RM51 Learning from experience. 10. Consultation and review This policy has been reviewed by members of the Risk Management Team with comments sought from a variety of staff across the Trust including divisional managers, divisional directors, assistant divisional managers, risk managers, head of service, modern matrons, specialist staff including complaints and PALS managers. It was consulted upon at the CQC Compliance away day on Friday 13 July 2012 11. Implementation of policy Incident/near miss reporting and investigation policy (including serious incidents) v6.1 16
This policy will be implemented in accordance with OP27 Policy for the development, management and authorisation of policies and procedures. It is also included in corporate and mandatory training, the staff handbook and relevant staff education/training events. 12. References 1. Department of Health, June 2000. An Organisation with a Memory 2. Department of Health, April 2002 Building A Safer NHS For Patients 3. Department of Health, August 2001. Doing Less Harm. 4. National Patient Safety Agency, July 2005. Building a Memory: preventing harm, reducing risks and improving patient safety 5. Department of Heath. December 2006 Safety first: A report for patients, clinicians and healthcare managers. 6. Department of Health, July 2004. National Standards, Local Action, Health and Social Care Standards and Planning Framework 7. National Health Service Litigation Authority, April 2006, General Risk Management Standards-Pilot. 8. Medical Devices Agency, March 2002. Safety Notice MDA SN2002(01) 9. Health and Safety at Work Act 1974 10. South of Tyne & Wear Serious Incident Reporting and Management Policy March 2012 11. Checklist for reporting, managing and investigating information governance serious untoward incidents Gateway ref:13177 12. Managing Serious Incidents in the English NHS National Screening Programmes Guidance on behalf of the UK National Screening Committee (UK NSC) Version 4 June 2010 13. Associated documentation It is important that other appropriate policies are read in conjunction with this policy and all Trust policies are relevant. Specifically the following policies are of prime importance: Datix user guides RM01 Risk management strategy RM02 Health and safety policy RM21 Complaint and concerns policy RM23 Claims management RM49 Being open RM51 Learning from experience RM67 Supporting staff involved in an incident complaint or claim PP35 Raising concerns at work RM74 Mental Capacity Act 2005 RM68 Safeguarding children and young people in Gateshead OP45 Safeguarding vulnerable adults Police/Health & Safety (HSE) Investigations protocol Checklist for reporting, managing and investigating information governance serious untoward incidents Gateway ref:13177 Incident/near miss reporting and investigation policy (including serious incidents) v6.1 17
Managing Serious Incidents in the English NHS National Screening Programmes Guidance on behalf of the UK National Screening Committee (UK NSC) Version 4 June 2010 Incident/near miss reporting and investigation policy (including serious incidents) v6.1 18
Appendix 1 Process for the reporting and management of incidents Incident occurs Employee action: 1. Address the immediate health needs of the person(s) involved 2. Inform the person in charge of area/department/senior manager. Where there is a serious incident/potentially serious near miss inform Divisional Manager/Head of Risk Management immediately (Out of hours - site manager) 3. Complete an incident form via the Incident Reporting System (Datix) - (Identifying investigator and where medical staff in training involved additional investigator as well) Investigator action: Review the level of actual harm and risk grade the incident according to the actual consequence of the incident at the time of occurrence Open: Severe/death within 24 hours: moderate harm within 48 hours: no harm/low harm within 5 days Low/very High risk/severe low harm/death or no harm/low harm Moderate risk/moderate harm Low harm/ no harm -Report incident immediately to person in charge/senior manager -Report to divisional Manager/Head of Risk management/art night site manager out of hours -Head of Risk Management initiate SIRP process (See appendix 2) -Inform appropriate senior member of staff -Investigator to carry out investigation within 28 days (see para 6.2) -Inform patient/relatives/carers -Support staff -Identify significant risks outstanding -prepare action plan -complete and sign off action plan If there are outstanding actions which cannot be completed include on risk register -Ensure all documentation attached to Datix -Investigator to carry out brief review of incident within 14 days (see para 6.2) -identify any actions -implement and sign off actions If there are outstanding actions which cannot be completed include on risk register NB External reporting carried out by in accordance with appendix 6 Incident/near miss reporting and investigation policy (including serious incidents) v6.1 19
Serious Incidents and Never Events Definitions and procedures Appendix 2 1. Definitions Serious incidents: The definition of a Serious Incident is quite broad so the criteria detailed below gives an indication of the type of incidents which are likely to be included. The South of Tyne & Wear Serious Incident Reporting and Management Policy give more detailed definitions. Patients, individuals, or groups of individuals suffering serious harm or unexpected death whilst in receipt of health services. This includes screening and immunisation, radiation errors, equipment failures and pressure damage of grade 3 and/or 4. Grade 3 and 4 pressure ulcers should be reported following initial rapid root cause analysis to determine whether the case was unavoidable. Those which are deemed to be avoidable should be reported as a SI with appropriate investigation and recommendations. Serious injury or unexpected death of an individual to whom the organisation owes a duty of care including staff, visitor, contractor, or another person. A serious offence including homicide committed by an individual in receipt of mental health and/or learning disability services. A confirmed death of a patient due to hospital acquired infection including MRSA and Clostridium Difficile confirmed by notification on Parts 1 or 2 of the Death Certificate. Any serious Information Technology related incident occurring which impacts, or has the potential to impact, on clinical care of patients and service users including all systems used or required to deliver patient and or service user care e.g. PAS, GP systems, results reporting systems etc. Actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals. Allegations of serious professional misconduct. (Please refer to NHS South of Tyne and Wear Policy Handling Concerns about the Performance of Independent Contractors). Adverse incident which would invoke an emergency plan (affecting business continuity including multiple ward or practice closure, due to infection, serious damage to occupied NHS property through fire, flood or criminal damage, IT failure). Patients detained under the Mental Health Act (1983) who abscond from health services and who present a serious risk to themselves and/or others. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 20
The admission of a child of under the age of 16 to an adult psychiatric ward must be notified as a SI. Where a child is over 16 and not yet 18 years of age there are specific criteria which must be met with regard to their accommodation. This list is not exhaustive and if there are any doubts about whether an incident can be deemed a Serious Incident please contact the Head of Risk Management Never Events which are to be reported through the Serious Incident reporting process. Wrong site surgery Wrong implant/prosthesis Retained foreign object post-operation Wrongly prepared high-risk injectable medicine Maladministration of potassium-containing solutions Wrong administration of chemotherapy Wrong administration of oral/enteral treatment Intravenous administration of epidural medication Maladministration of Insulin Overdose of midazolam during conscious sedation Opioid overdose of opioid-naïve Patient Inappropriate administration of daily oral methotrexate Suicide using non-collapsible rails Escape of a transferred prisoner Falls from an unrestricted window Entrapment in bedrails Transfusion of ABO blood components Transplantation of ABO or HLA-incompatible organs Misplaced naso- or oro-gastric tubes Wrong gas administered Failure to monitor and respond to oxygen saturation Air embolism Misidentification of patients Severe scalding of patients Maternal death due to post partum haemorrhage after elective caesarean section. 2. Procedures during and immediately after the incident The process for reporting and managing SI s is outlined in the flowchart on appendix 3. The South of Tyne & Wear Serious Incident Reporting Policy and Management Policy should be followed to identify and manage the STEIS reporting process. Where the police or the Health & Safety Executive (HSE) are involved the protocol for dealing with Police/HSE investigations should be taken into account. Any information given to staff and the public must be recorded and form part of the investigation record. The Serious Incident Review Panel (SIRP) (for Terms of Reference see appendix 12) will decide on the appropriate action for the type of incident. Senior clinical and management staff must be involved and informed, but lines of communication must be minimised to ensure consistent messages Incident/near miss reporting and investigation policy (including serious incidents) v6.1 21
If the incident involves a patient, a designated member of the SIRP (maybe a co-opted member with a management responsibility for the area concerned) together with the Consultant responsible for the patient, will immediately communicate details of the incident to the patient and the patients family. The patient and their family must always be told first before details are released to other parties such as the media. (See RM49 Being open policy) In the event of a suspicious patient death the Chief Executive will liaise with the Medical Director, Director of Nursing, Midwifery & Quality, and Head of Risk Management. The police and coroner will be notified as appropriate. The SIRP will take on responsibility for ensuring that: Managers and staff are consulted to take immediate steps to prevent a recurrence of the incident The Coroner is notified of any death The patients GP is notified - if relevant Other staff/organisations whom the incident may affect or who require a report are notified e.g. GP, PCT, CTG, NHSLA, NPSA, Police, HSE, Public Health (see appendix 6) 3. Preliminary analysis When preliminary information is available the SIRP should decide whether the incident is to be formally declared as a serious incident. If necessary, the Head of Risk Management will formally report the incident to the Primary Care Trust (Commissioners) as soon as possible using the electronic reporting system (STEIS) See Guidance for Notifying External Agencies Appendix 6. The SIRP will identify a Lead Investigator to co-ordinate an investigation team. This may be a member of medical staff (not involved in the incident) where appropriate who will be responsible for reporting the outcome of the investigation to the SIRP. 4. The investigation team The Lead Investigator will inform all relevant staff of the intention to set up an investigation team. (Where any member of the SIRP has been, or may be, directly or indirectly implicated in the events leading up to, or through any part of the serious incident they are to be excluded from the investigation team. The Chief Executive will decide if it is appropriate to involve such excluded persons in the consultation process and whether it is appropriate for them to act in any capacity as the expert advisor) An initial meeting will be held to agree: o The Investigation Team membership e.g. Head of Risk Management, Divisional Risk Manager, Caldicott Guardian o Roles/responsibilities and identification of a facilitator o Format of investigation o Timescale/time commitment for the review process o Enquiry process Incident/near miss reporting and investigation policy (including serious incidents) v6.1 22
o Authority o Secretarial support/duties The first meeting should take the form of a briefing and will include: o Gaining an understanding of the aims o Agreeing the style and process of the investigation o Sharing expectations of each role and each other o Agreeing key milestones and how the various investigative strands will be brought together 4. Membership The team must: Have at least one member who is fully trained in incident investigation and root cause analysis Possess the skills and specific knowledge to contribute to the investigation, so that their roles can be clearly defined Be able, and prepared, to give the necessary time 6. Format of investigation Consideration of the format of the investigation should include: The investigation process to be undertaken. The need for any expert opinion: internal or external Meetings schedule How findings will be brought together, recommendations agreed Identification of Lead person(s) responsible for the implementation of recommendations It is likely that dedicated and intensive periods of time will be necessary to achieve an efficient and expeditious investigation: this time commitment should be clearly defined 7. Timescales All investigations should be completed within 28 days for consideration by the SIRP to allow for reporting to the NPSA and the PCT (or Commissioners) within their timescales. 8. The investigation process See guidance on investigations (para 6.3) and RCA (appendix 7) 9. Confidentiality Details of the investigation must not be released to the media without discussion with the Trust s Head of Communication and/or an Executive Director. 13. Multiple/serial incidents In the event that the incident is such that there may be multiple enquiries, the hotline arrangements will be enforced as outlined in appendix 11. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 23
11. Stakeholder reporting In addition to those external agencies detailed in appendix 6 there are other stakeholders who require, or might require, information on specific adverse patient incidents, including: Patient s general practitioner Coroner Food Standards Agency Police Public Health Laboratory Service This is not an exhaustive list and others may be identified as appropriate. 12.Media reporting Consideration to the content of any press statement will need to be given; this should be under the specific auspices of the Head of Communications. If the incident involves many people, as it may do where infectious disease is involved, the positive use of the media as a primary means of communication with large numbers of people may be considered. In these circumstances the prior setting up of a hot-line service, to field questions from the public, is essential. Incident/near miss reporting and investigation policy (including serious incidents) v6.1 24