SERIOUS UNTOWARD INCIDENT POLICY AND PROCEDURE Terry Service Prepared by Responsible Area: Risk Management Approval Information: Date Approved: Governance Committee 02.05.07 COMMITTEE:- Approved By: Sign Print Name Version No.: Three Review date: April 2008 Department of Health 2004 Standards for Better Health Reference to Standards First domain Safety for Better Health Fourth domain Governance Domain Core/Development Core Standard C1 C1B D1 C7B C8A standard 1. Number of incidents reported. Performance indicators 2. Adherence to timescales 3. Reporting of incidents to SHA Description: It is essential that all serious and untoward incidents that occur in the PCT are reported appropriately and handled effectively. This document covers PCT Policy and the reporting procedures and describes the actions that will be taken in terms of communication and follow up when a serious or untoward incident occurs. It will provide guidance to all staff employed by the Trust. It is the responsibility of each manager to ensure that all staff are conversant with this policy and its procedural contents. Section Title Page number 1 1.1 PCT Policy Statement 4 2 2.0 Background Information 4 2.1 Introduction 4 2.2 Standard Definitions 5 2.3 Information 5 2.4 Roles and Responsibilities 5 2.5 Fair Blame Culture 6 2.6 Links with supporting organisations (stakeholders). 6 3 3.0 Procedure for Serious Untoward Incidents (SUI) 6 3.1 Internal reporting 6 3.2 Immediate action 7 3.3 Action within 24 hours 8 3.4 Action within five working days 9 3.5 Action within eight weeks 9 3.6 Internal reporting and audit of actions 9 3.7 Reporting to the Strategic Health Authority 9 3.8 Investigation 10 3.9 Communication requirements 11 3.10 Communication with patients, their families and carers 11 3.11 Communication with the media 11 3.12 Incident room and help line 12 3.13 Staff support 12 App 1 Examples of Serious Untoward Incidents App 2 List of supporting organisations (stakeholders) App 3 PCTSUI report form. National enquiry reports App 4 SHA Good practice principles for incident management App 5 SHA report information. App 6 SHA Exception report information App 7 SHA suggested action plan App 8 Information on statement provision App 9 Information for staff References Kirklees Primary Care Trust Serious Incident Policy and Procedure 1.0 PCT Policy Statement 1.1 The Kirklees Primary Care Trust is committed to working together to improve services for patients, staff and the general public. Part of this principle is to make sure that when things go wrong, events are reported and reviewed and that learning and action takes place, to prevent similar occurrences in the future. In order to make sure staff comply with this policy they are required to be aware, understand and follow the procedure set out in this document. The procedure sets out the accountability arrangements for Serious Untoward Incidents (SUI’s) within the PCT. 2.0 Background Information 2.1 Introduction A robust system for identifying and managing serious incidents allows the PCT to investigate incidents quickly, to review practice and identify trends and patterns. This document lays out the process to be followed should a serious untoward incident occur. It is one of a set of documents that underpin the risk management and Clinical Governance programmes for the Trust. The PCT has a responsibility to work with statutory bodies such as the Police and this procedure does not supersede the normal legal requirements to notify other agencies of certain incidents. All serious untoward incidents must be reported to the Strategic Health Authority (Yorkshire and Humber) using the process outlined in this document. It is essential that all serious and untoward incidents that occur in the PCT are reported appropriately and handled effectively. This document covers the reporting arrangements and describes the actions that will be taken in terms of communication and follow up when a serious or untoward incident occurs. It will provide guidance to and be understood by all staff employed by the Trust. It is the responsibility of each manager to ensure that all staff are conversant with this policy and its contents. This policy should be read in conjunction with the following PCT documents: Incident reporting policies and procedures. Risk Management Strategy Incident, Complaint and Claims policies and procedures. Risk Assessment policies and procedures. Emergency Plan Whistle Blowing Policy Media Handling policies and procedures. West Yorkshire Strategic Health Authority (WYSHA): Serious Untoward Incident policies and procedures. Infection Control Policies 2.2 Standard Definitions Definition of a serious untoward incident (SUI). A SUI may be defined as an incident where a patient, member of staff, or member of the public has suffered serious injury, major permanent harm, or unexpected death or where there is cluster/pattern of incidents or actions by NHS staff which have caused or are likely to cause significant public concern. ‘Near misses’ may also constitute SUIs, where the contributory causes are serious and under different circumstances could have led to serious injury, major permanent harm, or unexpected death, but no actual harm resulted on this occasion. A possible example is that of a system failure, the result of which is incorrect/delayed diagnosis. This may not have any serious consequences for some patients, but for others could lead to the wrong treatment/serious delay in treatment and ultimately to death. Examples of Serious Untoward Incidents are shown as Appendix 1. 2.3 Information In the course of the Trust’s business, incidents occur which have serious/potentially serious consequences for patients, the public, staff and the organisation. The PCT has a responsibility to ensure that the risks to all concerned are minimised and that every effort is made to learn from experience and improve clinical practice, organisational practice, systems of working, policies and procedures. One approach to executing these responsibilities is to conduct the review of serious incidents in a manner, which is in keeping with the Trust’s commitment to openness in all of its activities. A sound system for identifying and managing serious incidents allows the PCT to investigate incidents quickly, to review practice and identify trends and patterns. It enables monitoring and evaluation of the quality of patient care, procedures, systems of working and training. The system also identifies liability risks and helps to prepare the Trust’s response to legal claims that may naturally arise out of an incident. 2.4 Roles and Responsibilities The Chief Executive has overall accountability for Risk Management but will devolve the responsibility for the overall management of Serious Untoward Incidents to the Director of Corporate Services. The management lead for a SUI investigation will usually be the Director with responsibility for the area in which the SUI arises. They may delegate this responsibility to one of their immediate deputies but should seek support from staff with specialist skills, knowledge and experience to assist with the task. The implementation of actions arising from any investigation or inquiry remains the responsibility of the relevant directors and managers, along with the debriefing and support to individuals following a serious incident. The PCT is responsible for ensuring that all commissioned services have robust systems to manage any SUI and that they report them through to the PCT. The Director of Corporate Services is responsible for ensuring that any SUI that occur with a commissioned services is investigated and ultimately reported to the relevant authorities e.g. Health Care Commission and the SHA. 2.5 Fair Blame Culture The PCT recognises that most serious incidents occur as a result of the accumulation of a number of factors and events all conspiring together. Staff should be encouraged to report incidents without fear of disciplinary action in a culture of learning so that quality infuses into all aspects of the Trust’s work. Fear of disciplinary action may deter staff from reporting an incident. The view of the PCT is that disciplinary action will normally not form part of the response to an incident, except in cases where: In the view of the Trust, and or any professional registration body, the actions causing the incident/arising from the incident were far removed from acceptable practice. Where there is failure to report an incident in which the member of staff was either involved or about which they were aware. 2.6 Links with supporting organisations There are a number of organisations who are able to support the PCT with the management of a SUI. These include the National Patient Safety Agency (NPSA), The Health Care Commission, The National Clinical Assessment Authority and the Strategic Health Authority (Yorkshire and Humber). The involvement of these organisations must always be considered as part of any investigation. The Risk Management Team for the PCT will ensure that all statutory reporting is completed e.g. the Health and Safety Executive. Appendix 2 provides a detailed list of organisations who may be able to assist in any part of an investigation. 3.0 Procedure for Serious/Untoward Incidents In order for a SUI to be managed effectively a number of actions need to occur at set times. These actions are designed to ensure that the safety of patients and staff occurs as a priority, the relevant staff, managers and organisations are advised on a priority basis and resources are made available. 3.1 Internal reporting It is important that the Chief Executive should be informed of any serious incidents as soon as possible, according to their level of severity. This will usually be within 1- 2 hours during the working day but must occur within 24 hours of the incident. Out of Hours the Director on Call may be advised in the absence of the Chief Executive. In order to achieve effective internal reporting, the following actions must be undertaken. 1) The Director on Call must be informed immediately of any of the serious incidents. 2) The Director on call will then inform the Chief Executive (CE), the Director with responsibility for where the SUI occurred and the Head of Communications. 3) The CE will ensure that the PCT Chair is informed as appropriate. 4) The CE, or the Director on Call will decide whether the incident is serious enough to inform the Strategic Health Authority. 5) If an internal inquiry is required, this should be established as soon as possible with a Director and investigating officer appointed. The Strategic Health Authority is responsible for informing and briefing the Department of Health and ministers. Once the decision has been made to brief partner organisations and stakeholders, e.g. NHS Direct, PCT staff, GPs and other contractors, Local Authority, MPs, Strategic Health Authority etc then the Communications Team will ensure that they are briefed and receive regular updates via their relevant Communication Teams. 3.2 Immediate action As with any incident the most important action is to ensure that all patients and staff are safe and this must always be completed first. If any action is taken to ensure patient or staff safety then this must be recorded as it may play a vital part in the investigation especially where any items of equipment have been moved to make the area safe. The next action is to ensure that the relevant support and authority is brought in to help manage all aspects of the case. This will involve contacting line managers who should then escalate the case up to include contacting the Director (which will include the Director on call during out of hours). In conjunction with the Director and senior managers decisions will be made to: 1. Inform patient(s) & family/carer/relatives (refer to section eighteen). 2. Inform Police / other agencies. 3. Provide support to staff and patient(s). 4. Provide support to onlookers/public. 5. Quarantine equipment 6. Secure case notes and records. 7. Identify all individuals who may be involved in the case. 8. Advise the Chief Executive. 9. Contact the SHA especially if there is a possibility of adverse media interest or there is a need to agree a media handling strategy. 10. Contact specialist staff from the PCTe.g. Public Relations, Risk Management. It is important that as much of the incident is captured early on and therefore it helps if relevant documentation is completed as soon as possible. This includes the completion of a PCTSUI report form (Appendix 3) which needs to be sent to the Director on call preferably within one hour. It is accepted that in certain circumstances this will not be possible but in these cases it should be reported to the line manager and a timescale provided. The first few hours of an incident are often the most important and therefore there are a number of specific actions that need to occur depending on the severity of incident. These actions will include; 1. Ensuring that the relevant support is provided to patients, relatives, carers and staff. 2. Securing all items of equipment, records, case notes, files, data and relevant information including contact details of all staff, patients and authorities involved. All equipment involved with the case must be quarantined and other than in a police or HSE investigation the equipment must not be released to any other third party (including other NHS or commissioned services) without the express authority of the Director of Corporate Services or deputy with responsibility for SUI. 3. Informing the Strategic Health Authority who then opens an entry in the SHA electronic data base known as UNIFY (formally known as STEIS). It is always beneficial to provide early information to the SHA in the first instance with more detailed information at a later stage. If there is any doubt on the need to inform the SHA the advice should be sought from the Integrated Governance Team on 0113 2952089 or pager on 07699 760979. 4. Linking with partner organisations to ensure that communication channels are opened on at least three levels; 1) Clinician to clinician 2) Risk lead to risk lead 3) Communications lead to communications lead. 3.3 Within 24 hours. Initial statements must be completed from all staff who may have been involved. Where necessary formal statements may be required at a later stage and these will be obtained in due course. Appendix 4 provides a template for statements and gives information for staff on the process that is followed. A log of all documents related to the incident should be completed with all documents well secured. Where documents are required as part of a police investigation then these must be provided as requested. For criminal investigations consent is not required to release records but any records being released must be copied first and a record made of what documents have been handed over, where there are going, who took them and when. 3.4 Within 5 working days A management report/review needs to be prepared by the investigation lead and submitted to the lead director within five working days with the objective of establishing if any further action is required. At this stage the report is considered as an interim action that will be used in discussion with the PCTDirectors and the Strategic Health Authority. 3.5 Within eight weeks. The SHA will expect to receive a completed report on the investigation and must include the recommendations on actions taken to minimise the risk of reoccurrence include the recommendations on actions taken to minimise the risk of reoccurrence and the agreed action plan. The report must be signed off by the Chief Executive or a Board Director with clearly identified leads and timescales and a process for ensuring that all actions are completed. Appendix 4 sets out the minimum points that the SHA will expect to see contained within the final report. If the eight week timescale cannot be delivered then the SHA Integrated Governance Team must be advised on the causation and the timescales and UNIFY updated as necessary. Appendix 5 gives the minimum information that the SHA will expect to receive from this report which must be submitted on an exceptions basis 3.6 Internal reporting and audit of actions All Serious Untoward Incidents will be reported to the PCT Board via the Governance Committee. The Governance Committee will take an overview of all findings and actions related to the SUI and will ensure that there is an audit trail to ensure that all actions are completed. The operational aspects of the SUI management will be through the PCT Risk Management arrangements. Appendix 7 contains example of an action plan. 3.7 Reporting SUI to the Yorkshire and Humber Strategic Health Authority. All NHS Trusts are required to report all serious untoward incidents to the Strategic Health Authority. These include both clinical and non-clinical incidents as identified in Appendix three The Chief Executive’s office and director (and delegated lead) with responsibility for risk management hold details of “passwords” for accessing UNIFY. Access to UNIFY is controlled and access details will not be provided without the authority of the Director of Corporate Services. The Director on Call or the risk management lead should telephone the SHA to discuss/add to the UNIFY report, particularly where there are concerns about patient safety or potential media interest. Out of hours, the PCT should page the SHA first line on-call manager if the SUI is of an exceptional nature and immediate support is required. In these cases it will be necessary to ring pager number 07699 760979 and leave a message with the operator to contact the SHA on-call manager. The report is made electronically on UNIFY as soon as practically possible (at the latest within 24 hours of the incident during the working week). Reports must be anonomised and contain no identifiable information e.g. patient or staff names. The SHA will acknowledge receipt of the UNIFY report by e-mail within two working days. One role of the SHA is to identify any similarities in reports including trends and similar incidents from other organisations and to assist with ensuring that learning takes place across the NHS. Any major updates to UNIFY should be supported by a telephone call or email to the Integrated Governance team using the safe have email address at; firstname.lastname@example.org) In cases where there are serious concerns about the actions of an individual health professional and s/he is considered likely to be seeking work with other employers who would be unaware of the concerns then the Integrated Governance team at the SHA will ensure that the Trust/PCT liaises with the Regional Director of Public Health, who will issue an alert letter on behalf of the SHA if the relevant criteria are met. This action is in line with DH guidance ‘Handling concerns about the performance of healthcare professionals: principles of good practice.’ Where a SUI involves more than one NHS organisation (e.g. a patient affected by system failures both in an acute hospital and in primary care) then the SHA will aid in making the decision to ensure that a lead organisation is identified and reports the joint findings through to the SHA. It is the role of the SHA to performance manage timescales and to ensure that feedback is provided to all Trusts in the Yorkshire and Humber region on any trends and lessons that have been learned. 3.8 Investigation Any investigation completed within the PCT requires staff and resources to be allocated to complete the task within the timescales. Directors and senior managers are tasked with ensuring that the investigation and resources are proportionate to the scale and complexity of the SUI in question. Staff conducting an investigation must be suitably trainied and experienced in completing investigations which should use the National Patient Safety Agency Root Cause Analysis as the tool of choice. In more serious cases, particularly where there is likely to be significant public interest, it may be advisable to commission an external review or include an external representative on the investigation team. In these cases it is a requirement to inform the SHA that these representatives are being utilised and to provide the Terms of Reference. Any inquiries must not interfere with other investigations both internal or external e.g. with the Police, HSE or HCC but can be conducted at the same time providing there is no conflict of interest. For precisely these case the Department of Health have in place a Memorandum of Understanding between the DH, HSE and Association of Chief Police Officers (February 2006) on investigating patient safety incidents involving unexpected death or serious untoward harm. This is available from the DH. Appendix 4 also gives best practice guidance provided by the SHA on investigations 3.9 Communication requirements Clear Communication is a vital action both initially and subsequently both to seek a cause of the incident and to ensure that lessons are learnt and owned by anyone involved or affected by the incident. 3.10 Communication with patients and their families or carers. Normally, communication with patients or clients and their relatives will be via the appropriate member of the operational staff e.g. District Nursing Sister. In the first instance the action is to ensure that patients, clients and relatives are supported and advised that an investigation would be conducted and they would be advised of the outcome. It is important that staff do not try to suggest any causation, blame or identify any person involved to a patient without seeking the authority of senior manager. This action is to ensure that only facts are communicated and patients, clients, relatives and other staff are not misinformed. Any requests for information by the media must be referred to the Head of Communications or a Director within the Trust. Staff must not under any circumstances provide statements to the media. This action is again to ensure that the information provided is factual and that no misinformation takes place. 3.11 Communication with the media. The Head of Communications is responsible for ensuring that communications channels are opened and maintained with patients, stakeholders and the media and for making sure that the information provided is factual and agreed by the PCT Directors. No information will be provided to the media before it has been given to patients and stakeholders especially the SHA for complex cases involving other organisations. The Head of Communications will ensure that all requests for information are logged and responded to as necessary. 3.12 Incident Room and help line. For more serious incidents it may be necessary to set up an incident room with hotline phone lines. Hotline phones will be staffed and managed by PCT staff with a record of all calls being made and provided to the investigation team and where necessary any stakeholders or external investigations e.g. the police. The responsibility for ensuring the hotline numbers are circulated to the general public rests with the communications manager supported by the SHA. The PCT Emergency plan contains specific instructions on how to set up and manage an incident room with equipment provided in all major PCT premises. The PCT Emergency Plan is updated regularly and is therefore not included within this document. 3.13 Staff Support Any Serious Incident has the potential to affect staff both physically and emotionally and this must be supported. The need to provide support may occur directly after the incident or some time afterwards and managers should be alert to those factors which may necessitate support and provide the relevant resources for this to take place. For the purpose of managing Serious Untoward Incidents The term ‘staff ‘ should include directly employed staff and contractors who have been involved in the case e.g. General Practitioners and their staff. The welfare of staff involved in any serious untoward incident must be considered, particularly in relation to psychological trauma or stress. Any support offered must remain confidential to the individual. Managers and Directors should seek advice from the Human Resource Department and Occupational Health on what to look out for with staff who have suffered or may be suffering from stress resulting from an incident. The Occupational Health Department will offer individual counselling either directly or via referral to a commissioned service authorised and financed by the PCT. Staff should be made aware of this service and given the telephone number and encouraged to contact the department to access this service as necessary. It is also important for staff to be kept fully aware of the progress of an inquiry with which they have had clear associations. This will be the responsibility of the investigating team. In particular, staff involved should be kept aware of progress and when the report has been completed, the findings, recommendations and action to be taken should be relayed to them, giving them the opportunity to ask questions. Appendices 8 and 9 give information to staff on making a statement and being involved in a SUI investigation.