The Newcastle upon Tyne Hospitals NHS Foundation Trust. Serious Incidents (SIs) Reporting and Management Policy

Transcription

1 The Newcastle upon Tyne Hospitals NHS Foundation Trust Serious Incidents (SIs) Reporting and Management Policy Version No.: 7.0 Effective From: 5 August 2015 Expiry Date: 5 August 2017 Ratified By: Corporate Governance Committee Date Ratified: 13 July Introduction 1.1 Serious Incidents in health care are adverse events, where the consequences to patients, families and carers, staff or organisations are so significant or the potential for learning is so great, that a heightened level of response is justified. This policy is based on the Serious Incident Framework (NHS England, 2015) which describes the circumstances in which such a response may be required and the process and procedures for achieving it, to ensure that Serious Incidents are identified correctly, investigated thoroughly and, most importantly, learned from to prevent the likelihood of similar incidents happening again. 1.2 In the event of a Serious Incident (SI) occurring within the Newcastle upon Tyne Hospitals NHS Foundation Trust the incident should be reported internally via Datix and externally via the Strategic Executive Information System (StEIS). 1.3 The reporting of serious incidents via StEIS does not supersede the normal legal requirements to notify other agencies of certain incidents (listed in Appendix 1). Nor does it remove any responsibility to comply with national guidance issued by Monitor, Department of Health or other organisations such as the NHS Litigation Authority, Care Quality Commission (CQC), National Reporting and Learning System (NRLS), NHS Estates or Medicines and Healthcare Products Regulatory Agency (MHRA). In such circumstances the procedures in this document should be followed in conjunction with national guidance. 1.4 Managers should be aware of Department of Health guidance that exempts details of individual SI reports under either or both sections 31(2) and section 40 (2 and 3) of the Freedom of Information Act Policy scope The Newcastle upon Tyne Hospitals NHS Foundation Trust is committed to the reporting of SIs to identify and learn from sources of error and risk which may lead to damage, loss or harm, complaint or legal claim for negligence and to comply with the requirements of Monitor, Commissioners, Care Quality Commission and National Health Service (NHS) Litigation Authority. Page 1 of 22

2 3 Aim of policy 3.1 The aim of this policy is to facilitate learning by promoting a fair, open, and just culture that abandons blame as a tool and promotes the belief that incidents cannot simply be linked to the actions of the individual healthcare staff involved but rather the system in which the individuals were working. Looking at what was wrong in the system helps organisations to learn lessons that can prevent the incident recurring. 3.2 The policy endorses the recognised approach applied within the NHS (currently referred to as Root Cause Analysis investigation). This is a process for undertaking systems-based investigations that explore the problem (what?), the contributing factors to such problems (how?) and the root cause(s)/fundamental issues (why?). 3.3 Section 6 outlines the steps to be taken for the reporting and management of SIs. This has been formulated to comply with the Commissioners requirements and to sit alongside the Trust s Management and Reporting of Accidents and Incidents Policy. The document sets out roles, responsibilities and timescales for action. The purpose of the document is to ensure that serious incidents are managed and investigated in a coordinated, timely and thorough manner within a supportive environment. 4 Duties (Roles and responsibilities) 4.1 Trust Board To ensure the Duty of Candour is upheld in relation to sharing information with parties affected by patient safety incidents Consider and respond to any recommendations arising from investigation of an SI 4.2 Chief Executive The Chief Executive is ultimately responsible for ensuring the Trust is compliant with reporting requirements. 4.3 Director of Quality and Effectiveness Will ensure Board Directors and the Chief Executive are made aware of potential SIs Provide evidence to Commissioners that the Trust is complying with national guidance in relation to reporting all SIs and Duty of Candour. 4.4 Head of Patient Safety and Risk Will report SIs externally to relevant bodies on behalf of the Trust Coordinate investigations of SIs on behalf of the Trust Will ensure all decisions are recorded with regard to whether or not an incident will be classified as an SI Liaise with Directorate managers and senior clinical staff to ensure the Duty of Candour requirements are met. Page 2 of 22

3 Submit reports to the Corporate Governance Committee in relation to compliance with this policy 4.5 Serious Incident Panel To provide a high level forum in which to oversee and monitor the reporting and review of serious incidents to ensure a robust and consistent process is applied. To ensure recommendations arising from internal reviews and enquiries of serious incidents are implemented across the Trust and progress monitored accordingly. Where recommendations cannot be implemented due to lack of resources or capability, this will be escalated to the Executive Team in the first instance and subsequently to the Corporate Governance Committee via the Corporate Risk Register if unresolved. 4.6 Directorate Managers/ Heads of Department Have a duty to implement local systems to ensure that staffs comply with the SI policy and procedure, in particular: relevant staff are aware of the SI policy and procedure ensure that staff involved in SIs receive support potential SIs are identified on a timely basis incident forms are completed and submitted promptly there are effective systems for communication and management of SIs out of hours recommended actions are monitored until the action plan has been achieved. Duty of Candour requirements are implemented by ensuring patients and their families are told about patient safety incidents that affect them, receive appropriate apologies, are kept informed about investigations and are supported to deal with the consequences. 4.7 Human Resources Department Will work with relevant managers and SI investigators to ensure staff involved receive support Will advise and support the management investigation process as required following the incident investigation (see 6.7.2). 4.8 All Staff It is the duty of every employer to ensure, as far as is reasonably practicable, the health, safety and welfare of employees. This, together with the duty of care and cooperation imposed on each employee, requires that all serious incidents or near misses which do or could potentially result in harm should be reported to the appropriate level of management within the Trust, initially via the electronic incident reporting system or on a paper incident form, available to all wards and departments. An employee s duty to report applies even if they are not directly or potentially affected. Page 3 of 22

4 All employees within the Trust must understand what may constitute a serious incident or near miss and the processes for reporting and investigating such events. 4.9 Lead Investigator Will conduct the investigation within the agreed timeframes. Make all necessary decisions to manage the incident effectively. Identify and communicate with all necessary parties in an efficient and methodical manner. Analyse the incident and the way it was handled and make recommendations for future implementation On Call Medical Director Will decide whether an incident that happens out of hours is of an exceptional nature and requires immediate investigation by the Police or Health and Safety Executive 4.11 Patient Services Coordinator Must ensure that any serious incidents that happen out of hours are escalated to the on call Medical Director for advice and decision Falls Prevention Coordinator Reviews all fall incidents reported via Datix and identifies those that have resulted in serious harm or death Notifies the Patient Safety Team of incidents that meet the SI criteria to enable prompt reporting Carries out a RCA in conjunction with the Ward manager 4.13 Tissue Viability Team Reviews all hospital acquired pressure ulcers in order to identify those that are category 3 or 4 and may meet the SI criteria. Notifies the Patient Safety Team of any pressure ulcers that meet the criteria for reporting as SIs. Contact the ward manager to request the RCA be undertaken Organise a serious incident review meeting to discuss the findings of the RCA 4.14 Infection Prevention and Control Team Informs the Patient Safety Team of all cases of hospital acquired Clostridium Difficile and MRSA bacteraemia that have contributed to the death of a patient and may meet the SI reporting criteria Information Governance team Responsible for reviewing all information governance related incidents and for notifying the Patient Safety Team of any that potentially score level 2 or above and may meet the SI reporting criteria (Appendix 4 - IG grading). Page 4 of 22

5 5 Definitions Serious Incident (SI) Serious Incidents include acts or omissions in care that result in; unexpected or avoidable death, unexpected or avoidable injury resulting in serious harm - including those where the injury required treatment to prevent death or serious harm, abuse, Never Events, incidents that prevent (or threaten to prevent) an organisation s ability to continue to deliver an acceptable quality of healthcare services and incidents that cause widespread public concern resulting in a loss of confidence in healthcare services. (see Section 6.1 for examples of categories of SIs). Near Miss a prevented safety incident. Duty of Candour- patients and their families are to be told about patient safety incidents that affect them, receive appropriate apologies, are kept informed about investigations and are supported to deal with the consequences. The contractual Duty of Candour applies to patient safety incidents that occurs whilst a person is receiving care under the NHS Standard Contract and that result in moderate harm, severe harm or death (using NPSA definitions 1 ) Root Cause Analysis - A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individuals concerned and seeks to understand the underlying causes and environmental context in which an incident happened. 1 Never Events - A particular type of serious incident that meet all the following criteria: They are wholly preventable, where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level, and should have been implemented by all healthcare providers. 6 Procedure for reporting and managing serious incidents 6.1 What is a serious incident (Examples but not exhaustive)? For the purpose of this procedure, a SI is any incident on Trust premises, or elsewhere whilst in NHS-funded or NHS regulated care involving; patients, relatives or visitors staff contractors, equipment, building or property Acts and/or omissions occurring as part of NHS-funded healthcare (including in the community) that result in: Unexpected or avoidable death of one or more people. This includes 1 National Patient Safety Agency National Framework for Reporting and Learning From Serious Incidents Requiring Investigation Page 5 of 22

6 suicide/self-inflicted death; and homicide by a person in receipt of mental health care within the recent past; Unexpected or avoidable injury to one or more people that has resulted in serious harm (e.g. falls resulting in fractures. Hospital acquired pressure ulcers category 3 or 4); Unexpected or avoidable injury to one or more people that requires further treatment by a healthcare professional in order to prevent the death or serious harm of the service user; Actual or alleged abuse; sexual abuse, physical or psychological illtreatment, or acts of omission which constitute neglect, exploitation, financial or material abuse, discriminative and organisational abuse, self-neglect, domestic abuse, human trafficking and modern day slavery where: - healthcare did not take appropriate action/intervention to safeguard against such abuse occurring; or where abuse occurred during the provision of NHS-funded care An incident (or series of incidents) that prevents, or threatens to prevent, an organisation s ability to continue to deliver an acceptable quality of healthcare services, including (but not limited to) the following: Failures in the security, integrity, accuracy or availability of information often described as data loss and/or information governance related issues (see Appendix 4 for further information); Property damage; Security breach/concern; Incidents in population-wide healthcare activities like screening and immunisation programmes where the potential for harm may extend to a large population (see below); Inappropriate enforcement/care under the Mental Health Act (1983) and the Mental Capacity Act (2005) including Mental Capacity Act, Deprivation of Liberty Safeguards (MCA DOLS); Systematic failure to provide an acceptable standard of safe care (this may include incidents, or series of incidents, which necessitate ward/ unit closure or suspension of services); or Activation of Major Incident Plan (by provider, commissioner or relevant agency) Major loss of confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation One of the core set of Never Events as updated on an annual basis and currently including: Page 6 of 22

7 Surgical wrong site surgery, wrong implant or prosthesis retained foreign object post-procedure Medication mis-selection of a strong potassium-containing solution Wrong route administration of medicines overdose of insulin due to abbreviations or incorrect device overdose of methotrexate for non-cancer treatment mis-selection of high strength midazolam during conscious sedation Mental Health failure to install functional collapsible shower or curtain rails, General falls from poorly restricted windows chest or neck entrapment in bed rails transfusion or transplantation of ABO-incompatible blood components or organs misplaced naso-gastric or oro-gastric tube scalding of patients Incidents in Maternity Services which cause serious concern relating to maternity care or midwifery practice should also be reported to the Local Supervising Authority Midwifery Officer. Any incident involving the following issues in maternity services should be reported to the Commissioners in addition to the Centre for Maternal and Child Enquiries: unexpected intrapartum still birth unexpected maternal or neonatal death including cot death in hospital serious birth trauma to the baby, for example, scalpel wound at caesarean section or skull fracture at instrumental delivery baby abduction Screening incidents - Actual or possible failure of the screening service that has consequences for the clinical management of patients e.g. loss of test results, failure to detect cancers, incorrect notification of results to a patient or groups of patients. The screening programmes which are covered are:- breast cancer, cervical screening, bowel cancer, diabetic retinopathy, abdominal aortic aneurysm, fetal anomaly, infectious diseases in pregnancy, sickle cell and thalassaemia, newborn blood spot, newborn hearing and newborn and Infant Physical Examination. Incidents involving the Cervical Screening Programme (NHSCSP) Page 7 of 22

8 should be handled in accordance with the protocol documented in Interim Guidelines for Managing Incidents in the NHS Cervical Screening Programme" NHSCSP Publication No 11. Dec Adverse outcomes reasonably associated with routine NHS activity are excluded from this procedure. 6.2 Immediate action to be taken following an Incident It is an overriding responsibility of all employees to take immediate action at the scene of an incident to minimise injury and/or obtain appropriate treatment for individuals. Employees should consider what immediate action may be required to prevent further injury. Employees should have regard for their own health and safety at such times and should summon assistance whenever appropriate Individual employees, volunteers, contractors or students must report to their supervisor or head of department, as soon as practicable, any incident they have witnessed or been involved in Before reporting is commenced, some incidents will require prompt and specific action to deal with the problem. For example: Patient Related Incidents Where the incident relates to an inpatient, the patient s Medical Consultant must be informed as soon as possible. The Consultant will be expected to advise the patient (or where applicable the patient s relatives) of the circumstances of the incident and offer a reassurance that a full investigation will be undertaken. A full, contemporaneous record of the information provided to the patient/patient s relatives regarding the incident should be documented in the health records by the Consultant. Staff Related Incidents consider what support staff on duty may require after the initial scene has been made safe (e.g. additional staffing, counselling or support from Occupation Health or Human Resources) consider if arrangements need to be made for leave of absence to be granted. 6.3 Reporting a suspected SI Directorate Managers/Heads of Department must ensure that the Director of Quality and Effectiveness and/or the Patient Safety Team, is informed as soon as possible by telephone where a SI is suspected. When the incident occurs out of hours the on call Medical Director should be informed of the incident by the Patient Services Coordinator The Directorate Manager/Head of Department will be responsible for contacting the Patient Safety Team on the first working day following the Page 8 of 22

9 incident to report the circumstances of the event and seek further guidance if so required. It may be that a potential SI has been identified via local reviews of the incident reports. Directorate Management Teams will be responsible for ensuring that there are local procedures in place for the prompt review of incidents to ensure the identification of potential SIs on a timely basis The Patient Safety Team will alert the Director of Quality & Effectiveness (or designate in their absence) of the potential SI immediately following receipt of the verbal notification from the Directorate Manager/Head of Department Following receipt of the initial notification of a SI the Patient Safety Team will be responsible for preparing a summary of the incident along with details of immediate action taken, date, time and location of incident (Appendix 2) Out of hours, the on call Medical Director may decide that if the SI is of an exceptional nature, for example, requiring immediate investigation by the Police/HSE and/or likely to attract media attention, such as in the case of a major fire on NHS premises causing severe service disruption that the Commissioner on-call should be notified. This will be a verbal report with the agreement of the Chief Executive or nominated deputy. A decision as to whether to formally report the SI to the Commissioners will be made on the first working day after the incident has occurred. 6.4 Determining a Serious Incident The Director of Quality & Effectiveness (or designate) will consult with two Board Directors (or designated deputies) for a decision on whether the given incident should be classified as an SI. Where the incident involves a clinical circumstance, one of the Board Directors must be the Medical Director or the Nursing and Patient Services Director. Confirmation is not required prior to reporting falls resulting in fracture; trust acquired pressure ulcers category 3 or 4; or death due to HCAI Where there is a difference in opinion between the Board Directors, they will discuss the incident and reach a decision on the future management with the Chief Executive. The decision of the Board Directors, and the reasons for this, must be recorded on the notification form by the Patient Safety Team Where an incident is declared a SI, the Board Directors will determine who will act as the responsible Board Director. The Responsible Board Director will normally be the Director for the area where the incident occurred. The Responsible Board Director will commission the investigation and formally appoint the Lead Investigator. In the event that a decision is made that an incident should be referred to the Police a single initial point of contact between the Trust and the Police will be determined by the Responsible Board Director. The Responsible Board Page 9 of 22

10 Director will maintain communication with the Chief Executive on the management and investigation of the SI All SIs (actual and potential) will be reviewed by the Serious Incident panel in order to confirm the investigation plan and to consider if any urgent action should be taken to minimise risk In cases where the HSE/Police or other enforcement agencies are involved, these organisations may initiate their own investigation and request interviews with and information from Trust staff. The Board Directors will agree who will act as the Trust Coordinator in such instances. 6.5 Helpline Arrangements There will be occasions when an incident will necessitate the establishment of a helpline. The Procedure for Establishment of a Public Telephone Helpline should be utilised in such circumstances. Where the issue affects more than one organisation, agreement will need to be reached as to who will manage the helpline in order to avoid confusion. 6.6 External Notification of SIs to Commissioners and stakeholders The Patient Safety Team will be responsible for notifying the commissioners of all SIs. Initial notification will be via completion of the computerised notification form on StEIS as soon as practically possible (within two working days of the incident being confirmed). The Patient Safety Team will act as the liaison link between the Trust and the Commissioners during all stages of the incident investigation process. The Trust will keep the Commissioners informed of any significant developments in internal/external investigations, as appropriate Appendix 1 contains details of external stakeholders who should be considered prior to the commencement of the investigation. It will be the Lead Investigator s responsibility supported by the Head of Patient Safety and Risk to ensure that all relevant stakeholders are notified of the incident. A record of the stakeholders who have been notified must be retained as part of the SI investigation If the SI involves a vulnerable adult or child then advice should be sought from the Trust Safeguarding leads as to whether a cause for concern should also be submitted. See Child Protection- Policy and Procedures for Safeguarding Adults. 6.7 Investigation Process The Lead Investigator will be responsible for establishing the investigation team, ensuring that all the relevant disciplines and departments are represented. If the Lead Investigator believes that an Page 10 of 22

11 external expert is required, the decision to commission external help should always be referred to the Board Directors who declared the SI. The reason for instructing an external expert must be documented in the SI file. The Board Directors will consider the degree of error and seriousness of outcome when debating whether to commission an external review. The criteria that may result in commissioning an external review include: where on balance, a criminal charge is unlikely to follow, but could do so where there is a strong suggestion of clinical error where the effect of the error is to significantly harm the patient, or where the patient has died where the potential political ramifications are of national level when there is a reasonable belief that the action may be malicious and the Police have been informed When the investigation of a SI is carried out, it is not in itself a management investigation into any individual(s). The focus of a SI investigation is to establish what happened. This might then constitute a prima facie case for a management investigation to be undertaken. As a result of this investigation a number of courses of action may follow; these will be determined by the results of the management investigation. In this process it will be the role of the relevant Board Director to supervise the management investigation and the role of the Human Resources Department to advise and support this process as required Staff need support following any incident; however the more serious the incident, the more support is normally required. Being involved in an incident can be stressful for the individual, the team and the service. It is important that individuals should not feel isolated when involved in an incident. The Lead Investigator must ensure that adequate support mechanisms have been made available to staff. This may include referral to the Occupational Health department. See Supporting Staff Involved in Traumatic/Stressful Incidents, Complaints or Claims Policy Although the Lead Investigator will have latitude to determine the conduct of the investigation and will be mandated to ensure that a single coordinated, multidisciplinary investigation takes place, they are expected to meet a number of essential requirements. A robust investigation requires a questioning attitude that never accepts the first response, and uses recognised tools and techniques to identify: o The problems (the what?) including lapses in care/acts/omissions; and o The contributory factors that led to the problems (the how?) taking into account the environmental and human factors; and Page 11 of 22

12 o The fundamental issues/root cause (the why?) that need to be addressed. This includes: a root cause analysis of incident completion of chronology/time line of events conducting exploratory interviews collation of staff statements ensuring there is timely and sympathetic liaison with the patient/patient s relatives and staff during the course of the investigation (refer to the Trust s Being Open Policy) analysis of evidence formulation of recommendations compilation of report with action plan (see Appendix 3 for template) debriefing of staff after the investigation In respect of clinical incidents, the Lead Investigator will ensure that medical records are secured. Where records are required for the purposes of an external investigation, e.g. an inquest, criminal investigation or investigation by external experts, the Lead Investigator will ensure that copies are made and retained on the hospital site. 6.8 Communication If an incident is likely to result in media coverage, effective communication with staff is paramount. The timing and the extent of any information issued will be decided by the Chief Executive or nominated deputy The Chief Executive or nominated deputy will be responsible for overseeing the responses to all press enquiries and the preparation of press statements The Lead Investigator will ensure that where necessary a member of staff is identified to act as liaison link with the family/patient throughout the investigation. A record should be maintained of all such communications in line with the Being Open Policy and the Duty of Candour contractual and CQC requirements. 6.9 Duty of Candour/Being Open requirements For relevant reportable incidents, the Trust has several responsibilities under the Duty of Candour, including: Within 10 operational days of reporting the incident, Directorate Manager or Lead Clinician must inform the service user or relevant person that the incident has occurred (or is suspected to have occurred). The Trust must do this in person and include an appropriate apology Page 12 of 22

13 The Trust must provide the patient or relevant person with relevant information and support in relation to the incident The Trust must instigate and conduct a full investigation as soon as possible The Trust must offer the service-user or the relevant person a copy of the final report into the incident, within 10 operational days of the investigation being signed-off as complete Completion of Report On conclusion of the investigation, the Lead Investigator will forward the completed report and supporting SI file to the Patient Safety Team. The Director of Quality & Effectiveness will review the completed report to ensure that the incident has been properly investigated, that there is a clear and timely action plan and that the report complies with the SI requirements SI investigation reports must be submitted within 60 days of the incident being reported to STEIS, unless the incident requires an independent investigation in which case there is a 6 month timescale. The Trust will be notified by the Commissioners of the date the report is due. Where an investigation is unlikely to be completed within the set time frame, the Lead Investigator will be expected to provide an interim report, summarising the progress to date. The Patient Safety Team will advise the Lead Investigator of the date by which the interim report is required The Serious Incident Panel is responsible for reviewing the report to ensure it meets the requirements laid out in the SI framework and for identifying any actions in the report that need to be implemented widely Once the report has been agreed and accepted by the Executive Directors, this will be sent to the Chief Executive for final agreement prior to being sent to the Commissioners and to the patient/relatives if applicable The SI central file will be archived in the Clinical Governance and Risk Department. The Department will be responsible for advising the Lead Investigator and Executive Director when the commissioners have agreed closure of the file. 7 Training All Staff are trained in basic incident reporting requirements as part of their initial Trust and Local induction. Incident Investigators receive specialist training which includes the principles of root cause analysis, report writing and completing the investigation on DATIX. Page 13 of 22

14 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 any grounds. This policy has been appropriately assessed. 9 Monitoring compliance with the policy On a monthly basis the Director of Quality & Effectiveness will provide the Serious Incident Panel with a list of all new SIs and potential SIs reported in the last month and an updated monitoring chart which will show the progress against each SI investigation. Standard/ process /issue Incident reporting: All organisations must have an approved documented process for internal and external reporting of all incidents and near misses. Incident investigations: All organisations must have an approved documented process for investigating all incidents to enable learning. Monitoring and audit Method By Committee Frequency Quality Account contains the number and type of SIs reported each month Report on number of SIs reported and closed in time period Learning from incidents- Summary of incidents with Trustwide implications reported. Director of Quality and Effectiveness Director of Quality and Effectiveness/ Head of Patient Safety and Risk Head of Patient Safety and Risk Board Corporate Governance Committee Clinical Risk Group Monthly Bi-monthly Quarterly 10 Consultation and review This policy is subject to review on at least a biennial basis. The policy shall be reviewed through a process of consultation involving the Clinical Governance and Risk Department, the Corporate Governance Committee and Clinical Risk group. Appropriate guidance from the Trust regulators, NHS Commissioning Board and other relevant bodies shall be considered as part of the review. The Northumbria Internal Audit and Counter Fraud Service shall also review the policy before ratification. The policy will be ratified by the Corporate Governance Committee. Page 14 of 22

15 11 Implementation of policy (including raising awareness) The policy shall be disseminated to staff through the Intranet, the policy newsletter, incident reporting and investigation training and Directorate governance arrangements. 12 References NHS England (2015) Serious Incident Framework NHS England (2015) Revised Never Events Policy and Framework Department of Health (2013). Checklist Guidance for Reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation. Version2. Interim Guidelines for Managing Incidents in the NHS Cervical Screening Programme" NHSCSP Publication No 11. Dec Health and Safety Executive near-miss-reporting.htm Department of Health(2006)Safety First: A report for patients,clinicians and healthcare managers 13 Associated documentation The following documents have been referred to within this policy: Being Open Policy Child Protection- Policies and procedures Management and Reporting of Accidents and Incidents Policy Management of Medical Devices Policy Safeguarding Adults Supporting Staff Involved in Traumatic/Stressful Incidents, Complaints or Claims Policy Page 15 of 22

16 Appendix 1 Key Stakeholders Checklist Coroner ( in office hours. Out of hours via Police) NHS Protect ( office hours) nhsfraud@nhsprotect.qsi.gov.uk Department of Health (Customer Service Centre in office hours) Public Health North East Public Health England Centre ( ) Food Standards Agency ( office hours or emergencies only or Care Quality Commission (Ionising Radiation (Medical Exposure) Regulations 2000) ( , or Health and Safety Executive ( ) RIDDOR ( or Medicines and Healthcare Products Regulatory Agency (MHRA) ( in office hours or info@mhra.gsi.gov.uk ) NHS Estates Fire code reporting of fire incidents ( Buildings and non-medical equipment defect and failure reporting (Trust Estates Helpline 21000) NHS Litigation Authority (riskmanagement@nhsla.com ) Police (Public Protection Unit ) North East Commissioning Support Unit ( ) NECSU. Newburn-SI@nhs.net Professional Regulatory Bodies General Medical Council (Mon-Friday), Nursing & Midwifery Council (or ) Public Health Laboratory Service (Extension in office hours; out of hours via switchboard) Serious Hazards of Transfusion (SHOT) ( or shot@nhsbt.nhs.uk Social Services Child Protection: in office hours Vulnerable Adults: in office hours / Emergency Duty Team Children & Adults Trust Solicitor (via Legal Services FH, x31338 or x38068) Page 16 of 22

17 Appendix 2 The Newcastle Upon Tyne Hospitals NHS Foundation Trust Serious Incident (SI) Initial Notification Form To be completed by Head of Patient Safety and Risk or Patient Safety Advisor Name of Person Reporting Post Held Date of Reporting Date of Incident Time of Incident Site of Incident Incident report number Ward/Department Name of Affected Person MRN Date of Birth Nature of Incident (e.g. Surgical Error, Medication Incident, Fire) Full Details of Incident continue on separate sheet if necessary Affected Person and/or Relatives Informed of Incident Yes No If No, please explain why person/relatives have not been informed Action Taken Immediately Following Incident Internal/External Stakeholders which have been/need to be informed Details of any anticipated media and/or Political Interest Page 17 of 22

18 INCIDENT DECLARED SI YES Rationale For Decision NO BOARD DIRECTORS MAKING DECISION: NAME OF NOMINATED RESPONSIBLE DIRECTOR: DATE: FOR RISK MANAGEMENT USE: Nominated Lead Investigator Date reported on STEIS Date Final Report Due Page 18 of 22

19 Appendix 3 The Newcastle Upon Tyne Hospitals NHS Foundation Trust Template for Serious Incident (SI) Report and Action Plan The report should include the following: Introduction Brief details of the incident and the intended recipient(s) of the report. Terms of reference The purpose and structure of the task that has been assigned to the investigator. Methodology A list of persons interviewed and/or providing statements. A list of documents reviewed, referred to or used to support the report. Membership of the investigation team A list of persons involved and their role in the investigation. Chronology This must be factual and in strict date and time order. In a complex case it may be helpful to put it in the form of a table with columns for date, time etc. Background information The background to the incident, perhaps including clarification of the usual working practices in the area where the incident occurred or an explanation of clinical procedures if this is helpful to the investigation. Evidence This section will build on the chronology and set out the evidence gathered and any other documentation referred to e.g. local or national standards. It should be factual and any statement or opinion should be clearly identified as such, e.g. We were told that. Analysis The interpretation of the evidence collected during the investigation. Root cause analysis findings should be included in this section, along with consideration of practices and procedures to identify both good and poor practice. Conclusions This section should set out individual conclusions and may repeat points already made. Ideally conclusions will be ranked or organised in some way e.g. relate to sequential points in the chronology, go from most important to least important or separate points of good and bad practice. In any event, it should again be made clear which conclusions are about root causes of the event and which are not. This section should include a summary of lessons learned. Page 19 of 22

20 Recommendations This should include the intended approach to dissemination of lessons learned Action plan To include what needs to happen to achieve the outcome, the names or titles of persons responsible for the actions and specific timescales for completion. It is helpful to present the actions in a table. This must include the plan to communicate with the patient and/or their relatives in line with the Being Open Policy and Duty of Candour contractual requirements. All actions included must be carried out and confirmed as complete before the Commissioners will consider an incident for closure. Page 20 of 22

21 Appendix 4: Information incidents Where the incident relates to data loss or breach of confidentiality the appropriate senior staff should be notified immediately (and no later than 24 hours of the incident being confirmed in the working week). The Trust should report all information incidents rated as 1 and above via the IG Incident Reporting Tool and to the Commissioners through the usual channels, including the following information: Date, time and location of the incident. Breach Type Confirmation that appropriate and documented incident management procedures are being followed and that disciplinary action will be invoked, where appropriate, following the investigation. Description of what happened. Theft, accidental loss, inappropriate disclosure, procedural failure etc. The number of patients/service users/staff (individual data subjects) involved. The number of records involved. The format of the records (paper or digital). If digital format, whether encrypted or not. The type of record, breach or data involved and sensitivity. Whether the IG SIRI is in the public domain. Whether the media (press etc.) are involved or there is a potential for media interest. Whether the IG SIRI could damage the reputation of an individual, a work team, an organisation or the Health or Adult Social Care sector. Whether there are legal implications to be considered. Initial assessment of the severity level of the IG SIRI (see below). Whether the following have been notified (formally or informally): Data subjects Caldicott Guardian Senior Information Risk Owner Chief Executive Accounting Officer Police, Counter Fraud Branch, etc. Immediate action taken, including whether any staff have been suspended pending the results of the investigation. The severity of the incident will be determined by the scale (numbers of data subjects affected) and sensitivity factors selected. If the outcome in terms of the severity of the incident is IG SIRI level 2 (reportable) an notification will be sent from the IG incident Reporting Tool to the Health and Social Care Intelligence Centre External IG Delivery Team, Department of Health, Information Commissioner Office and escalated to other regulators, as appropriate. If the outcome is IG SIRI level 0 or 1 no notifications will be sent. The following process should be followed to categorise an IG SIRI Page 21 of 22

22 Step 1: Establish the scale of the incident. If this is not known it will be necessary to estimate the maximum potential scale point. Baseline Scale 0 Information about less than 10 individuals 1 Information about individuals 1 Information about individuals 2 Information about individuals 2 Information about individuals 2 Information about 501 1,000 individuals 3 Information about 1,001 5,000 individuals 3 Information about 5,001 10,000 individuals 3 Information about 10, ,000 individuals 3 Information about 100,001 + individuals Step 2: Identify which sensitivity characteristics may apply and the baseline scale point will adjust accordingly. Sensitivity Factors (SF) modify baseline scale Low: For each of the following factors reduce the baseline score by 1-1 for each No clinical data at risk Limited demographic data at risk e.g. address not included, name not included Security controls/difficulty to access data partially mitigates risk Medium: The following factors have no effect on baseline score 0 Basic demographic data at risk e.g. equivalent to telephone directory Limited clinical information at risk e.g. clinic attendance, ward handover sheet High: For each of the following factors increase the baseline score by 1 +1 for each Detailed clinical information at risk e.g. case notes Particularly sensitive information at risk e.g. HIV, STD, Mental Health, Children One or more previous incidents of a similar type in past 12 months Failure to securely encrypt mobile technology or other obvious security failing Celebrity involved or other newsworthy aspects or media interest A complaint has been made to the Information Commissioner Individuals affected are likely to suffer significant distress or embarrassment Individuals affected have been placed at risk of physical harm Individuals affected may suffer significant detriment e.g. financial loss Incident has incurred or risked incurring a clinical untoward incident Page 22 of 22

23 The Newcastle upon Tyne Hospitals NHS Foundation Trust Equality Analysis Form A This form must be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. PART 1 1. Assessment Date: 13/07/15 2. Name of policy / strategy / service: Serious Incidents (SIs) Reporting and Management Policy 3. Name and designation of Author: Jackie Moon, Head of Patient Safety and Risk 4. Names & designations of those involved in the impact analysis screening process: Jackie Moon, Head of Patient Safety and Risk 5. Is this a: Policy X Strategy Service Is this: New Revised X Who is affected Employees x Service Users X Wider Community 6. What are the main aims, objectives of the policy, strategy, or service and the intended outcomes? (These can be cut and pasted from your policy)

24 1.1 The aim of this policy is to facilitate learning by promoting a fair, open, and just culture that abandons blame as a tool and promotes the belief that incidents cannot simply be linked to the actions of the individual healthcare staff involved but rather the system in which the individuals were working. Looking at what was wrong in the system helps organisations to learn lessons that can prevent the incident recurring. 1.2 The policy endorses the recognised approach applied within the NHS (currently referred to as Root Cause Analysis investigation). This is a process for undertaking systems-based investigations that explore the problem (what?), the contributing factors to such problems (how?) and the root cause(s)/fundamental issues (why?). 1.3 Section 6 in the policy outlines the steps to be taken for the reporting and management of SIs. This has been formulated to comply with the Commissioners requirements and to sit alongside the Trust s Management and Reporting of Accidents and Incidents Policy. The document sets out roles, responsibilities and timescales for action. The purpose of the document is to ensure that serious incidents are managed and investigated in a coordinated, timely and thorough manner within a supportive environment. 7. Does this policy, strategy, or service have any equality implications? Yes No x If No, state reasons and the information used to make this decision, please refer to paragraph 2.3 of the Equality Analysis Guidance before providing reasons: The policy describes the process of incident reporting, investigation and monitoring of recommendations/actions required. The process should not differ for incidents involving patients or staff with protected characteristics.

25 8. Summary of evidence related to protected characteristics Protected Characteristic Race / Ethnic origin (including gypsies and travellers) Sex (male/ female) Religion and Belief Sexual orientation including lesbian, gay and bisexual people Age Disability learning difficulties, physical disability, sensory impairment and mental health. Consider the needs of carers in this section Gender Re-assignment Marriage and Civil Partnership Maternity / Pregnancy Evidence, i.e. What evidence do you have that the Trust is meeting the needs of people in various protected Groups Does evidence/engagement highlight areas of direct or indirect discrimination? If yes describe steps to be taken to address (by whom, completion date and review date) Does the evidence highlight any areas to advance opportunities or foster good relations. If yes what steps will be taken? (by whom, completion date and review date) 9. Are there any gaps in the evidence outlined above? If yes how will these be rectified? 10. Engagement has taken place with people who have protected characteristics and will continue through the Equality Delivery System and the Equality Diversity and Human Rights Group. Please note you may require further engagement in respect of any significant changes to policies, new developments and or changes to service delivery. In such circumstances please contact the Equality and Diversity Lead or the Involvement and Equalities Officer. Do you require further engagement? Yes No 11. Could the policy, strategy or service have a negative impact on human rights? (E.g. the right to respect for private and family life, the right to a fair hearing and the right to education?

26 PART 2 Name: Date of completion: (If any reader of this procedural document identifies a potential discriminatory impact that has not been identified, please refer to the Policy Author identified above, together with any suggestions for action required to avoid/reduce the impact.)