SERIOUS UNTOWARD INCIDENT POLICY AND PROCEDURES DOCUMENTATION CONTROL. NUH version 1 (1 November 2007) Supporting Procedure(s) Refer to section 12

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1 SERIOUS UNTOWARD INCIDENT POLICY AND PROCEDURES DOCUMENTATION CONTROL Reference GG/CM/019 Date Approved 1 October 2009 Approving Body Trust Board Implementation Date 1 October 2009 Supersedes NUH version 1 (1 November 2007) Consultation Undertaken Target Audience Clinical Risk Committee Organisational Risk & Patient Partnership Committee Directors Group Integrated Governance Team All NUH staff Supporting Procedure(s) Refer to section 12 Review Date September 2010 Lead Executive Author/Lead Manager Further Guidance/Information Medical Director Medical Director Head of Clinical Quality, Risk and Safety Head of Clinical Quality, Risk and Safety, Ext Deputy Medical Director, Ext October of 35

2 Paragraph Title CONTENTS October of 37 Page 1 Introduction 3 2 Policy Statement and Aims 3 3 Scope 5 4 Definitions Roles and Responsibilities: what to do All staff Responsible Manager Directorate Team, Clinical Director, Head of Service, Senior Manager Duty Director Medical Director Deputy Medical Director / Head of Clinical Quality, Risk & Safety Chief Executive Committees Trust Board Internal Inquiry and Report Serious Untoward Incident Inquiry Team (SIT) Conduct of the Inquiry Inquiry Report Format Finalising and Sharing the Report and Lessons Learned Action Plans and Monitoring Analysis of SUI Themes & Trends 17 8 Monitoring 18 9 Training Records Management & Confidentiality Document Storage and Confidentiality Disclosure of SUI Information (FOI) Equality and Diversity Statement Supporting NUH Policies and Procedures References 22 App 1 Criteria for reporting an SUI to PCTs & NHS EM 23 App 2 Integrated Governance Team Contact Numbers 28 App 3 Guide to the inquiry process 29 App 4 Timeline from reporting to completion 32 App 5 NUH Standard SUI report template 33 App 6 NUH Standard action plan template 34 App 7 Employee record of having read policy

3 1. INTRODUCTION Nottingham University Hospitals NHS Trust [NUH] is committed to improving patient, visitor and staff safety by reducing error and by learning lessons from untoward/adverse incidents and accidents. This policy describes Nottingham University Hospitals NHS Trust approach to the management of Serious Untoward Incidents [SUIs] and near misses, a key component of the Trust s Risk Management Strategy. An Organisation with a Memory (DoH 2000), Building a Safer NHS for Patients (DoH 2001), Safety First (DoH 2006), Darzi, High Quality Care For All (DH 2008) and Safely Does It (Healthcare Commission 2009) all emphasise the importance of learning from untoward incidents, shared across the health community. The National Patient Safety Agency (NPSA) shares NUH s commitment to promoting active learning and emphasis on a culture of open inquiry rather than of blame. The goal of incident management is to reduce the likelihood of recurrence, manage risks effectively, improve patient care and deliver safe services. The Trust seeks to establish an environment where the whole organisation learns from safety incidents, and where the investigation process is fair, equitable and focused on learning and change. 2. POLICY STATEMENT AND AIMS Nottingham University Hospitals NHS Trust is committed to the prediction, prevention and control of risk as a tool to improve the quality of patient safety, experience and outcome as described in the NUH Risk Management Strategy. The recognition and management of, and learning from, untoward incidents are crucial elements of the NUH Risk Management Strategy. Open, accurate, and timely reporting allows the Trust to put things right for the people affected (where possible), learn lessons and change our systems to prevent recurrence, and informs our priorities for training and investment. The Trust actively promotes an open but accountable culture, which enables staff to raise concerns around safety issues without fear of blame or retribution through participation in incident reporting. The Trust Board appreciates that completion of an incident report form may cause October of 37

4 fear of disciplinary action, and that this may deter staff from reporting incidents. Completion of an incident report form is not considered an admission of liability. Staff who make a prompt and honest report will be treated fairly and supported. Use of the disciplinary or capability procedures will only be considered as part of the response to an incident in very specific circumstances (eg where there is clear evidence of gross professional misconduct, where the same individual is involved in a number of incidents, or where there is deliberate failure to report an incident or to co-operate with an investigation). NUH seeks to exceed all national policies and guidance for openness and the provision of information for patients and their carers [Refer to NUH Being Open Policy 2009]. This policy supports NUH s statutory duty to report Serious Untoward Incidents. NUH recognises the importance of support and timely information for patients, relatives and staff involved in incidents. [Refer to NUH Being Open Policy] The comprehensive management of incidents allows prompt action to be taken to minimise the effects of the incident, reduce risk and improve the safety of patients, staff and visitors. A proactive approach to safety enhances our reputation and public confidence. Accurate and timely reporting of all incidents and near misses enables the organisation to identify themes and trends, which provide information to inform education and training programmes, revise policies, procedures and guidelines to enhance safety, and ultimately build on our strengths and improve areas of weakness. It informs the Trust of systems failures for which remedial action is necessary to reduce the likelihood of recurrence, and allows NUH to share information across the Health Service, for example via the National Patient Safety Agency [NPSA], and influence change at a national level. Incident management can help ensure that resources are targeted effectively when implementing solutions, and can provide an early warning of potential complaint or litigation. October of 37

5 Finally, a robust approach to incident management demonstrates compliance with external accreditation standards, for example the NHS Litigation Authority [NHSLA] Risk Management Standards and the Care Quality Commission Registration Requirements, and ensures that the Trust meets its legal obligations. 3. SCOPE This Policy describes the management of serious untoward incidents, clinical and non-clinical. It outlines the procedures and responsibilities of all staff for reporting, investigating and learning lessons from SUIs. The policy applies to all staff employed within the Trust (permanent or temporary or honorary), students and volunteers, contractors and employees of other organisations working on the Trust s estate. The policy applies to incidents in NUH premises, or in other premises where services are provided by NUH, or which occur as a direct consequence of NUH care. The Trust also recognises its responsibility to external regulatory and monitoring agencies, including: Commissioner Lead PCT NHS East Midlands [SHA] The National Patient Safety Agency [NPSA] The Health & Safety Executive [HSE] The Medicines and Healthcare Products Regulatory Agency [MHRA] The Serious Hazards of Transfusion scheme [S.H.O.T] Safeguarding Boards Health Protection Agency [HPA] Care Quality Commission [CQC] Police Counter Fraud and Security Management Services [CFSMS] NHS Estates [NHSE] HM Coroner The NHS Litigation Authority [NHSLA] 4. DEFINITIONS Several factors influence the degree of investigation required after an incident or near miss: the seriousness of the event (notably the degree October of 37

6 of harm suffered), the impact on service delivery or the reputation of the Trust, the likelihood of recurrence, the potential for learning and changing practice, and the frequency of events (even when no or little harm is caused). A Serious Untoward Incident is an event or accident in which: A patient, member of staff or member of the public suffers (or is exposed to the risk of) serious injury, major permanent harm, or unexpected death or Actions of NUH staff are likely to cause significant public concern or There might be serious impact upon the delivery of services and/or media attention and/or litigation and/or a serious breach of service standard or quality. NHS East Midlands provides an extensive list of examples, which is shown in Appendix 1. This list is not exhaustive. Advice should be sought from the Integrated Governance Team where there is any doubt for contact numbers refer to Appendix 2. Never Events are defined by the NPSA [Never Events Framework 2009/10] as serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. The document includes a description of the core list of Never Events and they are described in Appendix 1. Compliance with the Never Events policy seeks to strengthen transparency and accountability when serious patient safety incidents occur, acting as a lever for safer care and providing additional impetus to reducing serious, preventable and costly incidents. Near miss serious incidents should be reported in the same way as actual incidents. Incidents or near misses that are not serious should be managed as described in the NUH Policy for the Management of Incidents, including Near Misses. An adverse outcome reasonably associated with routine NHS activity (such as an operation) is not an SUI. Such outcomes should be subject to Morbidity and Mortality Meeting (M&M) review. October of 37

7 Directorates will wish to ensure that an event recognised some time later as an SUI (in M&M meetings or by other mechanism) is reported as an SUI and is subjected to appropriate investigation. Where there is doubt about whether an SUI has occurred, advice should be sought from the Head of Clinical Quality, Risk and Safety, Deputy Medical Director or relevant Executive Director. Incidents or adverse events that are not deemed Serious Untoward Incidents will be investigated in accordance with the Incident Reporting and Management Policy [2009] by the specialty or Directorate. Reviews will take place through Departmental Governance meetings, including Morbidity and Mortality meetings. 5. ROLES AND RESPONSIBILITIES (WHAT TO DO) 5.1 All staff The staff member who first becomes aware of an incident should: Ensure that immediate actions are taken to prevent further harm Report the events to their line manager (or senior member of staff on duty) [the Responsible Manager] Consider whether equipment or notes need to be quarantined or secured Report the incident using the hospital incident reporting forms (and send to the Integrated Governance Department) Ensure the clinical team looking after the patient is informed Some of the above may be too much for the person to undertake immediately after an incident and may have to be undertaken jointly with the responsible manager [see below, para 5.2]. On occasions, an incident may only be recognised as a Serious Untoward Incident some time after the event. In such cases the member of staff to whom such evidence comes to light must report the incident as described in this policy. Where a member of staff considers that an incident is not being properly addressed they should first discuss this with their line October of 37

8 manger, but they have recourse to the Trust s Whistleblowing Policy if their concerns are not allayed. 5.2 The Responsible Manager should: Confirm that all necessary immediate actions for safety have been taken. Help the reporting staff member complete the actions under 5.1. Follow the guidance set out in section 5 of the NUH Incident Reporting Policy & Procedures Manual [2009] Assess whether the event might be a SUI. If s/he considers this possible s/he should inform the Directorate Clinical Director, Clinical Lead, Head of Service or Duty Senior Manager on call [Silver]. Ensure that staff are aware of available support via their GP, Occupational Health, Human Resources Department, Right Corecare Employee Assistance Programme, Professional organisations and Trade Unions. Monitor staff who may have been affected by an SUI, direct them to support if appropriate, and inform the appropriate Directorate Clinical Director, Directorate General Manager or Clinical Lead of ongoing concerns. Ensure that any media requests for information about the incident are directed to the Communications Department. Encourage staff to record their recollections as soon as possible and practicable after an incident / event. (Such a personal record should NOT be placed in the patient case notes. Staff may wish to and should be advised to share such a record with their trade union or professional body). 5.3 The Directorate Team - Clinical Director / Clinical Lead / Directorate General Manager, Head of Service or Duty Senior Manager [Silver] will: Report any potential SUIs immediately to the Duty Director ( NUH Gold on call ). Ensure that the patient, member of staff, or member of the public involved in the incident (and, where appropriate, relatives or next of kin) are appropriately informed as soon as possible. They should be informed that an incident has occurred, together with the likely consequences and immediate actions being taken. October of 37

9 For patients it may be appropriate to delegate this to a senior member of the clinical team (where necessary the oncall Consultant). This discussion should be recorded in the medical record. For other involved persons the manager should keep a written record of all discussions Ensure that those principally involved are informed before any response is made to a media request (liaise with Duty Director (NUH Gold on Call ). The Line Manager should ensure that staff are aware of the available support, i.e. via their GP, Occupational Health, HR Department, Right Corecare Employee Assistance Programme and professional organisations and trade unions. Ensure that any media requests for information about the incident are directed to the Communications Department. 5.4 The Duty Director Seeks immediate advice from colleague Directors (notably from the Medical Director and Director of Nursing & Midwifery Where the incident is not confirmed as an SUI, the level of investigation will be commensurate with the guidance in the NUH Incident Reporting and Procedures Manual and may include an investigation at directorate level or a Mortality and Morbidity or departmental review (this list is not exhaustive). 5.5 The Medical Director Ratifies an event as an SUI, and ensures prompt communication with the CEO and with the Head of Clinical Quality, Risk and Safety (to agree notification of all relevant parties, including the commissioning PCT and NHS EM). Activation of the major emergency plan, or an incident liable to cause significant media interest or public concern, must be reported to the CEO immediately and to the commissioning PCT within two hours [for Major Incident management refer to NUH Major Emergency Plan]. Ensures that lines of responsibility to inform other agencies are followed in accordance with DoH Memorandum of Understanding Investigating Patient Safety Incidents involving unexpected death or serious harm: protocol for liaison and effective communications between the National October of 37

10 Health Service, Association and Chief Police Officers and Health and Safety Executive [Feb 2006]. Ensures that where there are issues of Child or Vulnerable Adult welfare or protection, these are considered and appropriate reports made in keeping with the Trust s Child Protection and Vulnerable Adults Policies. The Named Doctors for Child Protection and Vulnerable Adults and the Trust Secretary is available to provide advice. Agrees a communications strategy with the Director of Communications (or deputy) as soon as practicable. The Medical Director is accountable for the initial external and internal communication. Agrees with the Director of Communications (or deputy) who will liaise re the communications strategy with the commissioning PCT and NHS EM. Specifically considers with the Director of Communications (or deputy) whether a hotline should be established Ensures that those principally involved are informed before any response is made to a media request. Ensures that the Trust Board is notified at its next meeting. May, after discussion with the CEO, inform the Chairman and / or other Non-Executives at an earlier date. The Board notification may be in public or private session, at the discretion of the CEO and Chairman. Will consider if more than one organisation is involved in the SUI. The organisation that identified the incident must make the initial report to the commissioning PCT and NHS EM. Where this is NUH the Medical Director will arrange a meeting that includes all key stakeholders, and identify an appropriate Inquiry lead to co-ordinate and manage the investigation. This applies also to Independent Sector Providers. All organisations involved in an Inquiry have a duty to uphold the principles of confidentiality enshrined in the Caldicott principles and relevant statutes. May, in exceptional circumstances, after further consideration, downgrade an incident from an SUI. This must be discussed and agreed with the CEO. 5.6 The Deputy Medical Director [Patient Safety] and Head of Clinical Quality, Risk and Safety Appoints the Serious Untoward Incident Inquiry Team [SIT] from the NUH Governance Faculty who will be responsible October of 37

11 for ensuring the incident is investigated in line with this policy (and associated procedures). Ensures that within one working day a High Priority is sent to ALL Directors (if not already done by the Medical Director), informing them of the incident and that the SUI is reported to the Commissioning PCT, NHS EM and the untoward incident module of the Strategic Executive Information System [STEIS] is completed Ensure that any relevant previous SUIs and investigations are made known to the Medical Director and Chair of the Investigation Team. Convey to the Commissioning PCT and NHS EM (via the STEIS system) the investigation report, within 60 working days [extension of this period may be appropriate for complex investigations and should be by agreement with these bodies]. Ensure that all Directors and the relevant Clinical Director / Clinical Lead / Head of Service / Senior Manager, patient and relatives are informed if the Medical Director subsequently decides that the event is not an SUI (and that decision is ratified by the CEO) 5.7 The Chief Executive Is accountable for the management of SUIs, but delegates this responsibility as described in this policy. The CEO must ensure that information is available so that staff know how and when to report an incident. 5.8 Committees The Risk Management Committee [RMC] will monitor and review the effectiveness of this policy and the associated procedures. The Clinical Risk Committee [CRC] will review and ratify all SUI reports and recommendations, ensure that an action plan to implement safety solutions is developed by the most appropriate people with clearly identified accountability for actions, and ensure that investigations and reports (or relevant elements of them) are appropriately anonymized and shared with stakeholders. The action plan will be regularly monitored by the CRC to ensure timely closure. October of 37

12 Significant exceptions or deviations from the action plan(s) will be reported by CRC to the RMC this will ensure that any outstanding identified risks are addressed. The CRC will ratify closure of an SUI action plan, which will be reported to the RMC and the Board. The CRC or RMC may wish to involve other relevant Trust Committees in the response to an incident or SUI report. This is the responsibility of the Chairs of these Committees to ensure such involvement. The Risk Management Committee will receive monthly updates on the progress of all SUI investigations and associated action plans via the Medical Director. The Risk Management Committee will receive 6 monthly trend analysis reports on Serious Untoward Incidents and seek assurance on risk reduction measures taken. 5.9 Trust Board The Board delegates authority to the Audit Committee and Risk Management Committee to obtain and provide assurance on effective systems and processes for risk management activities including the management of incidents. The Board will receive monthly updates on the progress of all SUI investigations and associated action plans via the Medical Director. The Board will receive 6 monthly trend analysis reports on Serious Untoward Incidents and assurance on the action taken to increase safety and reduce future risk. 6. INTERNAL INQUIRY AND REPORT 6.1 Serious Untoward Incident Inquiry Team (SIT) Each SUI will be subject to comprehensive investigation. This will follow NPSA guidelines, and include Root Cause Analysis [RCA] Actions or omissions by staff members preceding an incident are frequently evident, but these are often difficult to eradicate because they frequently involve attention failures or memory lapses. Closer October of 37

13 analysis of the incident (RCA) may reveal a series of events and organisational or process issues in the period of care leading up to the adverse outcome. The action(s) of the individual member of staff may act as a trigger against the backdrop of these organisational shortcomings. The aim of an SUI investigation is to identify such shortcomings. RCA provides a consistent investigative approach that seeks to describe all the causal factor[s] of an incident, which enables the development of comprehensive solutions to reduce or eliminate the risks. It may be appropriate to use the SUI investigation process for the investigation of complaints. When an SUI Inquiry is being undertaken, any complaint will be made available to the Inquiry team. Only where the Inquiry team remit does not include all the elements of the complaint should a separate complaints investigation be undertaken (though the Inquiry Lead must ensure that the complaints department receives timely progress reports). The NUH Governance Faculty is made up of senior consultants who champion patient safety in their specialties and chair inquiries and complex clinical complaint investigations. The faculty also includes nurses, midwives and allied health professionals, providing a body of experience and knowledge to support investigation and shared learning. Training in incident investigation and root cause analysis will be provided for the NUH Governance Faculty and other key groups of staff. Membership of the SUI Inquiry Team [SIT] is agreed by the Deputy Medical Director and Head of Clinical Quality, Risk & Safety. Members are chosen from the NUH Governance Faculty. The Inquiry Team Lead is responsible for the conduct of the investigation. A SIT will usually comprise at least three persons who must not have been directly involved in the incident. They should include an appropriate senior clinician, a senior clinician who has clinical expertise that is relevant to the incident, and at least one senior manager or member of the Integrated Governance Team. This policy is not prescriptive about the required organisational level for SIT Lead or member. However where the incident has had October of 37

14 catastrophic impact (or might have had if a near miss) the Chair may be a Trust Director. In certain cases it may be appropriate to investigate an incident in partnership with another stakeholder [e.g. PCT or NPSA], or by appointment of an independent person or panel. The CEO must ratify any such joint inquiry team (and its membership) or external involvement. The terms of reference [ToR] for a SIT will be agreed by the Deputy Medical Director and Inquiry Lead. The SIT will have the CEO s authority to make all necessary enquiries of any staff in order that all possible lessons can be learned from the incident and recommendations made to prevent recurrence and improve patient and staff safety. The SIT Lead can at any time seek from the Deputy Medical Director a change in the ToR if s/he feels that is appropriate or necessary and in keeping with the principles and aims of this policy. The Inquiry Team Lead may wish to seek advice from the Head of Clinical Quality, Risk and Safety, the Trust Secretary or Legal Advisors. The Inquiry Team Lead will also have access to specialist HR advice (from the Director of HR) during the conduct of the investigation. For the majority of Infection Control SUIs the Medical Director (in his role as Director of Infection Prevention and Control) may agree that the relevant clinical team will assume the role of the SIT. 6.2 Conduct of the Inquiry The Inquiry is not part of the disciplinary process. The SIT however has a responsibility to examine and comment on the discharge of professional duties and accountability by those involved in the incident and to make recommendations. Only where there are significant breaches of expected standards and/or significant nonadherence to Trust policies and procedures will staff be subject to disciplinary proceedings. Staff should be reassured that the investigation s primary aim is not to establish blame, but to understand the organisational context within which the incident occurred (what went wrong, not who did wrong). October of 37

15 Staff should be open and frank with the Inquiry team, and the team should ensure that it has discussion with staff without fear of blame or retribution. Staff should be encouraged to record their recollections as soon as possible after an incident / event. Such a personal record should NOT be placed in the patient case notes. Staff may wish to and should be given the opportunity to share such a record with their trade union or professional body. A guide to the Inquiry process, including advice on support, writing accounts for the Inquiry, and what to expect if the Inquiry team interview you, is contained in Appendix 3. The SIT should always involve the patient concerned where possible and (with patient consent if appropriate) their relatives, in order to identify any specific concerns they may have and, by explanation, give them confidence in the thoroughness of the investigation process. Patients should be offered the opportunity to talk to the team and/or offer a written submission at the start of the investigation. The patient / [relatives where appropriate] should be kept informed of progress throughout the investigation by a member of the SIT. All NUH staff involved in an incident must work to support patients and relatives. This will involve explanation of the investigative process and referral to the Patient Advice and Liaison Service [PALS]. It will usually be appropriate for the clinical team involved to discuss events with the patient s GP. This discussion should be recorded in the patient s case record. Staff involved in an incident will require support. The Line Manager should ensure that staff are aware of available support via their GP, Occupational Health, HR Department, Right Corecare Employee Assistance Programme and professional organisations and trade unions. Some may need an identified mentor to support them through the process. The SIT Lead is responsible for keeping involved staff informed of the progress of investigations. The Integrated Governance Team provides an additional source of information and advice. To obtain the best results from its Inquiry the SIT should apply RCA methodology. Events should be considered in the following domains October of 37

16 Organisational and management factors Work Environment (e.g. staff levels, skill mix and work patterns) Team factors (e.g. communication and supervision) Individual staff factors (e.g. knowledge, skills) Task factors (e.g. availability of protocols / tests / results) Patient characteristics (e.g. complexity and seriousness) 6.3 Inquiry Report : Format The SIT Report should follow a standardised format, described in Appendix Finalising and Sharing the Report and Lessons Learned [see also Section 10] It is usual practice for the staff involved to have sight of relevant extracts of the report [to seek their confirmation on matters of factual accuracy] before it is submitted to the Clinical Risk Committee for review and ratification. The SIT Lead has discretion to waive this process if this is agreed with the Deputy Medical Director. The exercise of this discretion should be noted in the report. However, in circumstances where an individual staff member s actions are being criticised in the report, it is essential to allow them the opportunity to comment on the extracts at this stage, staff may wish to and should be advised to seek the advice of their Trade Union or Professional Organisation. The SIT report submitted to CRC and disclosed to staff should have all patient and staff personal data removed in accordance with paragraph 10. The Final Draft Report and suggested distribution list should be presented to the Clinical Risk Committee by the chair of the inquiry for review and ratification. CRC may seek further work, clarification or suggest amendment. The final version is the responsibility of the SIT Lead, who is responsible for version control. October of 37

17 The outcome will be described to the Board by the Medical Director in a scheduled or extraordinary report (as agreed by the CEO). The SIT Lead will always offer to meet patients and/or relatives if they so wish to share the findings and outcome of the investigation with them. The Trust may wish to offer a further meeting with Trust Officers after formal consideration of the report. There should be the widest appropriate distribution of an anonymised report. Patient and staff confidentiality must be preserved and should be considered in every draft of the report. Care should be taken to ensure that patient and staff personal details (see paragraph 10.2) are not included in general distribution of the SIT report. If legal proceedings are coincident with the Inquiry, the Lead should seek advice from the Head of Clinical Quality, Risk and Safety or the Trust Secretary on the report s distribution. The Report may include recommendations that it be forwarded to relevant professional bodies, notably the General Medical Council [GMC] and the Nursing and Midwifery Council [NMC]. The Medical and Nursing & Midwifery Directors may also recommend such a course. The final decision regarding such onward transmission rests with the NUH Board. General distribution should only be made in accordance with Section 10. The SIT Lead will consider with colleagues whether a formal staff meeting to consider the Report ( debriefing ) is required. Clinical Directors should identify forums through which the lessons learned in investigation and SIT recommendations can be disseminated through their directorate. The effectiveness of these mechanisms will be monitored by CRC. The Medical Director will be responsible for a quarterly LESSONS LEARNED BULLETIN, which will be distributed to all ward and departmental managers (via the hospital intranet). This will include synopses of all SIT Reports and Recommendations, suitably anonymised in accordance with Section 10. October of 37

18 6.5 Action Plans and Monitoring Each relevant Directorate [as agreed by the SIT Lead and Deputy Medical Director] should generate an Action Plan to address SIT recommendations. There is a standard format for this action plan, attached in Appendix 6. The plan should have clear timescales and describe named individual responsibilities. The plan should include a one-year review of each of the recommendations and (where appropriate an audit of the actions). The robustness of the Action Plan and its implementation (including the one-year audit) will be monitored by the CRC. 7 ANALYSIS OF SUI THEMES AND TRENDS The Integrated Governance Team will interrogate the Datix system to identify themes and trends. The Clinical Risk Committee, Organisational Risk & Patient Partnership Committee, Risk Management Committee and Trust Board will receive regular reports. Directorates and specialties have a responsibility to review all incidents associated with their services, to take action and provide feedback through their local forums. Directorates, Corporate Functions and Committees will work in collaboration to review themes, trends and action plans and to share lessons. 8 MONITORING The effectiveness of this policy will be routinely monitored through: Feedback of incident statistics and analysis to Managers and Committee leads Reports to the Risk Management Committee and subsequently to all other appropriate Trust Committees Trust-wide Audit. Reviews of investigations and follow-up action taken by local October of 37

19 managers/governance forums. Trust-level assurance to the Board through the Risk Management Committee and a monthly SUI register and report. 9 TRAINING To ensure that staff are aware of the importance of reporting and managing incidents and near misses training will be provided through: Corporate induction programmes Local induction packages Ongoing governance education Managers are required to promote staff involvement and attendance. Training and advice is available through the Integrated Governance Department on all aspects of this Policy and Procedures The principles described in the policy accord with the Trust s Risk Management Strategy, to which staff are introduced at induction. 10 RECORDS MANAGEMENT and CONFIDENTIALITY 10.1 Document Storage and Disposal Incident report forms are sensitive documents, should be considered confidential, and must be stored securely. The Trust has a legal obligation to retain incident forms for a period of 10 years. This is done centrally. Additional copies should be disposed as confidential waste once investigations and actions are complete. Incident forms are not part of a patient s healthcare record and must not be filed in patient notes. It is however usually appropriate to record that there has been an adverse event in the body of the record this is mandatory for all clinical incidents. Incident forms can however become the subject of internal and/or external scrutiny and must be completed to the same standards of accuracy with objective, factual description as expected in the clinical record Disclosure of SUI Information and Reports (FOI) October of 37

20 The Trust seeks to promote a culture of openness, which is a pre requisite for improving patient safety and the quality of healthcare systems. The Trust works to ensure compliance with all national policies and guidance on being open, and to provide information for patients and their carers in an open and non-defensive manner (see Being Open Policy). It is important to inform the person involved in the incident and, where appropriate, their next of kin as soon as practically possible, and to record this on the incident report form. Where a decision is taken not to inform the patient or next of kin, the reasons for this should also be clearly documented on the form AND in the body of the healthcare record. Any written information produced as part of the NUH SUI reporting process will be potentially disclosable under the Freedom of Information Act 2000 ( FOIA ), unless an exemption applies to the information. Given the nature of SUIs, any documents produced are likely to contain personal data or sensitive personal data belonging to patients, members of the public and/or staff. This information is protected under the Data Protection Act 1998 ( DPA ), and NUH is under an obligation to ensure that it is processed only in accordance with the data protection principles enshrined in the DPA. Personal information is defined as being information relating to a living individual who can be identified from that information. It must be biographical in nature. Personal data will be classed as sensitive personal data if it relates to racial/ethnic origin, political opinions, trade union membership, physical or mental health, sexual life, the commission or alleged commission of an offence or proceedings relating to an offence. When a request for SUI information is received from a third party, section 40 of the FOIA will be relevant. Information should not be disclosed if it would lead to personal information relating to patients, members of the public and/or staff (excluding details of staff acting in their official capacity) being disclosed in breach of the DPA and those individuals being identified. Care must be taken when disclosing any SUI information, and thought must be given to how information held by NUH may be October of 37

21 used in conjunction with other readily available information to identify individuals involved. Section 31 of FOIA will be relevant if a request for information is received during the SUI investigation process, but only to the extent that disclosure would prejudice the investigation. The Trust Secretary or Trust Solicitors should be consulted before any decision is made. Evidence of a significant risk of harm is required. The public interest test will also need to be applied before a decision as to disclosure is made. In addition, section 36 of FOIA may also be relevant if disclosure of information would or could prejudice the effective conduct of public affairs. This may be a risk if, for example, disclosure would inhibit the free and frank provision of advice or exchange of views by effecting the willingness of staff to come forward and report SUIs because of the fear of blame, or if disclosure would prejudice NUH s ability to offer an effective public service, or to meet its wider objectives, due to the disruption caused by the disclosure and the diversion of resources in managing the impact of disclosure. The decision on whether section 36 is applicable can only be made by the CEO. The public interest test will also need to be applied. As a guide, personal statements of staff should not be disclosed. Individual SIT reports should not normally be disclosed unless (1) you have consulted with the Head of Clinical Quality, Risk and Safety, Trust Secretary or Trust Solicitors, and (2) the reports are anonymised and (3) you are confident that no individuals can be identified from the report or in conjunction with other information available elsewhere. Lists of SUIs, recommendations, changes in practice, Lessons Learned Bulletins and statistical data should normally be disclosed but limited to describing the broad nature of the incidents, and no information should be included which could lead to the identification of the individuals involved. Date and location of the incident should be carefully considered in case this information makes it possible to identify individuals. It may also be advisable to put the data into context and emphasise the open reporting and learning aspects of SUI reporting. This should not be taken as a definitive rule, and each request for information should be decided on its own merits. The Trust Secretary or Head of Clinical Quality, Risk and Safety should be consulted before any disclosures are made. October of 37

22 11 EQUALITY AND DIVERSITY STATEMENT NUH 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 basis of their ethnic origin, physical or mental abilities, gender, age, religious beliefs or sexual orientation. 12 SUPPORTING POLICIES AND PROCEDURES Incident Reporting Policy & Procedures Manual [September 2009] Risk Management Strategy [October 2008] Being Open Policy [July 2009] Whistleblowing Policy [August 2006] Major Incident Plan [May 2006] DoH Memorandum of Understanding Investigating Patient Safety Incidents involving unexpected death or serious harm: protocol for liaison and effective communications between the National Health Service, Association and Chief Police Officers and Health and Safety Executive [Feb 2006] Infection Control Policy and Procedures [March 2008] Safeguarding Children and Vulnerable Adults Policy [NUH policy under development] Hotlines Policy [March 2008] Mental Capacity Act 2005 Policy and Procedures [August 2009]] Standards of Business Conduct Policy [January 2009] Coroner s Inquest Policy [May 2006] Claims Handling Policy [March 2008] Fire Policy Manual [April 2009] Fraud and Corruption Policy [April 2006] Grievance Policy [May 2009] Disputes Policy [June 2006] Management of Attendance and Sickness Policy [September 2008] Disciplinary Policy and Procedure [June 2009] DH Checklist for Reporting, Managing and Investigating Information Governance Serious Untoward Incidents [2009] October of 37

23 13 REFERENCES Safely Does It, implementing safer care for patients (Healthcare Commission 2009) Never Events Framework 2009/10, National Patient Safety Agency NHSLA Risk Management Standards (2009) Darzi A, High Quality Care For All: NHS next stage review final report, (DH 2008) Safety First (DoH 2006) Seven Steps to Patient Safety The full reference guide second print, (NPSA, 2004). Building a Safer NHS for Patients, (DoH 2001) Doing Less Harm, (DoH and NPSA 2001) An Organisation with a Memory, (DoH 2000) Management of Health and Safety at Work Regulations, (Health and Safety Commission, 1999) Reporting of Injuries, Diseases and Dangerous Occurrence Regulations, (Health and Safety Executive, 1996). Risk Management in the NHS, (NHS Executive, 1994). Health and Safety at Work Act, (Secretary of State for Employment, 1974). Appendix 1 October of 37

24 CRITERIA FOR REPORTING AN SUI TO COMMISSIONING LEAD PCTs AND NHS EM The following are incidents which will be considered for reporting and investigation as Serious Untoward Incidents. It is not an exhaustive list and is intended as a guide only. Where there are any doubts about an incident it should be reported following the procedure outlined in Section 5. Major Incidents Any circumstance which necessitates the activation of the Trust s major emergency plan. Never Events Wrong site surgery Retained instrument post operation Wrong route administration of chemotherapy Misplaced naso or orogastric tube not detected prior to use Inpatient suicide using non-collapsible rails Escape from within the secure perimeter of medium or high secure mental health services by patients who are transferred prisoners In-hospital maternal death from post partum haemorrhage after elective caesarean section Intravenous administration of mis-selected concentrated potassium chloride Other Incidents involving harm to Patients / Service Users Clusters of unexpected or unexplained deaths (report before investigation is undertaken to clarify suspicions) Maternal deaths (due directly or indirectly to pregnancy or child birth) Death or injury where foul play is suspected. Serious event including unexpected death, injury or errors involving patients e.g. medication errors, failures in diagnosis resulting in significant morbidity or mortality. Patient screening incidents e.g. actual or possible failures in the pathway, inadequate screening, exposing the patient/s to delays in treatment / serious consequences Death in custody October of 37

25 The suicide or suspected suicide of any persons currently in receipt of NHS services, on or off NHS premises, this includes o Patients currently in receipt of mental Health services, or who have been discharged within the last twelve months o Patients of primary care providers. o Where there is obvious evidence or strong suspicion of self harm or o Where the above does not apply initially but emerges later from a clinical review of the case, or discussion at the incident monitoring group, or o Where the Coroner s verdict is suicide (or open verdict) Safeguarding Children and Vulnerable Adults Serious incidents that result in death, significant injury or abuse to children where reported under child protection arrangements or an adverse event which results in a serious case review (Part 8) Significant harm to adults where reported under vulnerable adult arrangements. Allegations against staff who work with vulnerable Children or Adults Incidents involving Staff and Others Serious injury or unexpected death involving a member of staff, visitor, contractor or another person to whom the organisation owes a duty of care. All incidents where exclusion from duty is contemplated and there is likely to be public interest or the incident is of a serious nature as defined within this list: Serious complaints about a member of staff or primary care contractor Suspicion of a serious error or errors by a member of staff or primary care contractor A serious drug error resulting in harm to a patient. A serious breach of confidentiality. Loss / theft or unintended destruction of data / personal information that could lead to identity fraud or have other significant impact on individuals Serious verbal and/or physical aggression. Requests for the issuing of an alert letter. Problems that may have a serious impact on public health or there is a perceived threat to the health of individual patients. October of 37

26 Significant threat to public safety. If referral to the relevant regulatory body is contemplated. Suggestions of significant inappropriate conduct, sexual or otherwise. Definite criminal activity or involvement of the police. Significant inappropriate use of or prescription of controlled drugs. Strong likelihood of stories reaching the media. Individual incidents or clusters of incidents, which result in a midwife being put onto supervised practice. Suspected fraud Suspicions of high levels of mortality. Healthcare Associated Infection / Infection Control All identified cases of MRSA bacteraemia Specific cases of Clostridium Difficile (An outbreak of C.difficile and serious / fatal cases of C.difficile where there was a clear breach of prevention or treatment of C.difficile policies/guidelines. Incidents that result in significant morbidity or mortality. Involve highly virulent and transmissible organisms. Require control measures that have an impact on the care of other patients, including limitation of access to healthcare services. All community based outbreaks. Outbreaks that are sufficiently serious to require the convening of an incident team Transmissible with an impact on staff, patients or the community. Infected healthcare worker or patient incidents necessitating consideration of look back investigations (e.g. TB, vcjd, blood borne infections) Significant breakdown of infection control procedures with actual or potential for cross-infection (e.g. release of products from a failed sterilisation cycle, contaminated blood transfusion) N.B. These incidents should also be reported to the Health Protection Agency. Mental Health Incidents The disappearance, absence without leave or absconsion of a service user (whether or not detained under the Mental Health Act 1983) where there is serious cause for concern. October of 37

27 Homicide, or suspected homicide, by any service user who has received care provided by specialist mental health services, that is has been under the care programme approach (CPA). Escapes by patients (whether or not detained under the Mental Health Act 1993) from secure accommodation Forensic Mental Health Incidents Incidents occurring within high secure services (Rampton Hospital), have additional reporting criteria documented within the Forensics Untoward Incident Reporting Policy and are managed by the Forensics Lead at NHS EM. Premises / Equipment Incidents Failure of equipment which could endanger life. Serious damage to NHS or primary care premises or property e.g. through fire, flood or criminal activity which results in serious disruption to services. Suspicion of malicious activity e.g. tampering with equipment. Circumstances that lead to the provider no longer being able to provide an element of the service. Medico Legal Incidents Suspicion of large-scale theft or fraud, which might give rise to serious criminal charges or major litigation. Impending court hearing or out of court settlement in cases of large-scale litigation (including negligence claims). Incidents relating to Home Oxygen Service Any incident that involves the death of a patient where the integrity of the home oxygen service is challenged. Any serious failure of service delivery, including compromised supply of oxygen. Delayed discharge from hospital or inappropriate emergency readmission Health and safety incidents relating to the use of oxygen equipment including fire. An incident where the quality of healthcare has been significantly compromised this may include severe distress to service users and their carers October of 37

28 Other significant untoward incidents, including: Apparently trivial events, or clusters of events, which lead to something more significant, including those which could attract media attention Any deviation from the Retained Organs Commission Guidance. Actual or potential public health hazards [report to EPA and EM NHS Director of Public Health]. Death or serious injury from suspected or actual Non-accidental injury of a child or vulnerable adult (local child protection procedures must be followed and the area child protections committee must be informed). [Report to a designated Child Protection Doctor who will advise]. Referral of a member of staff to the Protection of Children Act 1999 List [report to NHS EM] An incident reported to National Confidential Inquiry [reported to NHS EM] October of 37