SERIOUS INCIDENT POLICY

Transcription

1 SERIOUS INCIDENT POLICY LEAD EXECUTIVE DIRECTOR: Name of Originator / author and job title: POLICY APPROVED BY: DATE POLICY APPROVED: August 2013 IMPLEMENTATION DATE: August 2013 REVIEW DATE: August 2016 Stephanie Dawe Chief Nurse & Executive Director of Integrated Care (Essex) Bridget Tustin, Head of Risk Management Executive Management Team Health & Safety Impact Assessment September 2013 Policy No: TW/GO0006/v002 Page 1 of 35

2 Document Control Sheet Policy title Policy number Assurance statement Target audience (policy relevant to) Links to other policies Risk management strategy Risk management policy Incident reporting policy Version control Status Version Stored By Serious Incident Policy TW/GO0006/v002 The purpose of this policy is to ensure that risks associated with serious incidents are identified and managed in accordance with best practice and in line with the expectations of the National Patient Safety Agency, the NHS Litigation Authority, the Health and Safety Executive, the Care Quality Commission, Monitor, Commissioners, NHS England and Clinical Commissioning Groups. All persons involved directly in a serious incident and those involved in the investigation process. Draft 0.4 Bridget Tustin Valid Stored at Last access by Last access date Name Date Policy No: TW/GO0006/v002 Page 2 of 35

3 Contents Paragraph Page 1. Introduction 4 2. Aims and objectives 4 3. Definitions 5 4. Roles and responsibilities 6 5. Serious incident process Glossary of terms Implementation process Monitoring arrangements Equality statement Training External references 21 List of all stakeholders consulted 22 Health & Safety Impact Assessment Form 23 Appendix 1 SI flowchart 26 Appendix 2 SI 24 hour alert 27 Appendix 3 SI 72 hour alert 28 Appendix 4 Grade 3 and 4 pressure ulcer reporting 29 Appendix 5 72 hour pressure ulcer update 30 Appendix 6 Safeguarding flowchart 33 Appendix 7 MRSA BSA PIR flowchart 34 EMT / Business unit leadership team approval checklist 35 Policy No: TW/GO0006/v002 Page 3 of 35

4 1. Introduction 1.1 Serious incidents requiring investigation in healthcare are rare, but when they do occur, everyone must make sure that there are systematic measures in place to respond to them. These measures must protect patients, staff and visitors and ensure that robust investigations are carried out, which result in organisations learning from serious incidents to minimise the risk of the incident happening again. 1.2 The purpose of this policy is to ensure that risks associated with serious incidents are identified and managed in accordance with best practice and in line with the expectations of National Patient Safety Agency, the NHS Litigation Authority, the Health and Safety Executive, the Care Quality Commission, Monitor, NHS England, Clinical Commissioning Groups and the public. Adherence with the policy supports the Trust in its objective to pursue continuous improvement in the delivery of its services, whilst being person-centered and acting openly, fairly and proportionately. The purpose of the policy is to formally endorse the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigations; be clear of roles and responsibilities; timescales for completing serious incident investigations and to define the additional requirements for serious incident reporting to all relevant external identified above. 1.3 The core values expressed in the NHS Constitution should be given priority of place and the overriding value should be that patients are put first, and everything done by the NHS and everyone associated with it should be informed by this ethos. In reaching out to patients, consideration should be given to including expectations in the NHS Constitution that: Staff put patients before themselves; They will do everything in their power to protect patients from avoidable harm; They will be honest and open with patients regardless of the consequences for themselves; Where they are unable to provide the assistance a patient needs, they will direct them where possible to those who can do so; They will apply the NHS values in all their work 2. Aims and objectives 2.1 This policy adopts a systems improvement approach to safety, as promoted by the National Patient Safety Agency (NPSA). As such, it acknowledges that the causes of incidents are not usually simply linked to the actions of individual staff members. The policy employs a systemwide perspective for the notification, management and learning from serious incidents. An investigation into an incident should apply root cause analysis methodology so as to identify system failures, rather than apportion blame to any one individual. This approach focuses on the need to treat the fundamental underlying problem rather than the Policy No: TW/GO0006/v002 Page 4 of 35

5 symptom. 2.2 Whilst adopting a systems improvement approach, this policy recognises that there will be occasions when patient safety is compromised because of unacceptable behaviour by individual members of staff. This policy rejects the unreasonable blaming or scapegoating of teams or individuals but adopts an approach best described as fair blame. 2.3 This policy is designed to support organisational openness, continuous learning and service improvement. The open and honest reporting of risks, hazards and incidents and their investigation is positively encouraged. The purpose of an investigation is to identify the cause of an incident and share the lessons learnt so as to prevent or minimise the chances of any repetition. If the review of an incident finds there is indication of serious misconduct appropriate disciplinary action will be pursued. 3. Definitions Openness and trust should also extend to others who have a legitimate interest in the way the Trust manages and learns from incidents: this includes patients, service users, carers, relatives as well as a number of external agencies. Notwithstanding, the purpose of a SI investigation is to establish system failures and the need to treat the fundamental underlying problem rather than the symptom. Therefore the investigation of SI from this perspective can run in parallel with any other concurrent internal investigation. The terms of reference of the SI investigation will clearly reflect this. 3.1 Serious Incident The definition of a serious incident (SI) extends beyond those incidents which impact directly on patients and includes incidents which may indirectly impact on patient safety or an organisation s ability to deliver on-going healthcare services in line with acceptable standards. A SI is defined as an incident that occurred in relation to NHS funded services and care resulting in one of the following: The unexpected or avoidable death of one or more patients, staff, visitors or members of the public. A death should be regarded as unexpected if natural causes are not suspected. Permanent harm to one or more patients, staff, visitors or members of the public, where the outcome requires life-saving intervention or major surgical/medical intervention, or will shorten life expectancy. This includes incidents graded under the NPSA definition of severe harm. A Never Event : never events are defined by the Department of Health. The list of never-events is reviewed annually: the current list is presented in A scenario that prevents, or threatens to prevent, a provider Policy No: TW/GO0006/v002 Page 5 of 35

6 organisation s ability to continue to deliver health care services. For example, actual or potential loss or damage to property, reputation or the environment. Abuse being defined as a violation of an individual s human and civil rights by any other person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal or psychological, it may be an act of neglect or an omission to act, or it may occur when a vulnerable person is persuaded to enter into a financial or sexual transaction to which he or she has not consented, or cannot consent. Abuse can occur in any relationship and may result in significant harm, or exploitation, of the person subjected to it. Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals. Further guidance on information governance SI can be found in the NELFT document library Adverse media coverage or public concern for the organisation or the wider NHS. Grade 3 and 4 pressure ulcers which developed whilst the patient was receiving care by NELFT staff. Has involved the exclusion (suspension) of a member of clinical staff, or a student on clinical attachment, for reasons associated with patient care, which are potentially high impact whilst acknowledging that the act of suspension itself is without prejudice. 3.2 Major Incident The term major incident is defined as ''Any occurrence, which presents a serious threat to the health of the community, disruption to service, or causes, or is likely to cause, such numbers or types of casualty as to require special arrangements to be implemented.' Please refer to the Trust Emergency Management Plan for Response to a Major Incident. All major incidents are reported as SI. 3.3 Critical Event These incidents are those that fall outside of the definitions and guidance for serious incidents but still require an investigation. These incidents will not be reported on StEIS but will adhere to all other principles contained within this policy. Guidance on the definitions of serious incidents requiring investigation, categories and examples of incidents can be found ( 4. Roles and responsibilities 4.1 Chief Executive The Chief Executive has accountability for ensuring the provision of high quality, safe and effective services within the Trust. The Chief Executive has overall responsibility for ensuring that appropriate and effective systems for the handling of incidents are in place. The Chief Executive must ensure that these systems enable the Trust to meet all relevant statutory requirements and also that the Trust complies with best practice as described by the Department of Health, Monitor, the NHS Litigation Authority and any other relevant external bodies. Policy No: TW/GO0006/v002 Page 6 of 35

7 4.2 Chief Nurse The Chief Nurse & Executive Director of Integrated Care (Essex) is the lead for the governance arrangements for SI and is responsible for identifying and controlling any identified clinical risks. The Chief Nurse & Executive Director of Integrated Care (Essex) is responsible for ensuring organisational learning takes place following the investigation of SI. The Chief Nurse & Executive Director of Integrated Care (Essex) has responsibility for the implementation of this policy through the management of Quality and Patient Safety Department. The Chief Nurse & Executive Director of Integrated Care (Essex) is responsible for ensuring that nursing and allied health professional staff across the organisation uphold the standards of their profession and, in so doing, are compliant with this policy. 4.3 Executive Medical Director The Executive Medical Director carries specific responsibilities for all matters relating to professional conduct of medical staff. The Executive Medical Director will provide expert advice where necessary and will give final approval of reports when required. 4.4 Managing Directors All directors (including managing, clinical, service, operational, assistant operational) and general managers are responsible for the implementation of this policy into practice within their service areas and taking appropriate action should any breach of this policy arise. 4.5 Senior managers All Senior managers have a delegated responsibility for ensuring that this policy is known to all staff and that its requirements are followed by all staff within their directorate/division/department. Senior managers have responsibility for ensuring that SIs falling within their sphere of management are reported and that lessons learned are applied across their directorate/service and beyond, as necessary. Operational/service director are responsible for making use of the online incident reporting system to ensure that SI are recorded in line with this policy and that risks within their directorate/service are identified and controlled. 4.6 Associate Director of Quality and Patient Safety The Associate Director of Quality and Patient Safety has responsibility for a range of Trust-wide corporate governance functions and ensures that appropriate reporting processes for serious incidents are in place. 4.7 Head of Risk Management Head of Risk Management is responsible for the SI investigation team; ensuring reports addressing serious incidents, including numbers, types, lessons learnt and trends are made available in line with the cycle of Policy No: TW/GO0006/v002 Page 7 of 35

8 business and ensuring all regulatory reporting requirements are met within the agreed timelines. The Head of Risk Management is responsible for administering the Trust s system for reporting, investigating and learning from SI. The post holder is responsible for producing and keeping updated, procedures, templates and guidance for enabling the reporting, investigating and learning from SIs: these items are held on the intranet within the SI Investigation Toolkit ( The post-holder takes a lead on further developing the organisation s competence in reflecting on and learning from SI. The post-holder has responsibility for producing reports of SI activity as defined in the organisation s cycle of business; regular reports to the commissioners at an agreed frequency and ad hoc reports as required. 4.8 Mental Health Law Manager The Mental Health Law Manager is responsible for overseeing use of the Mental Health Act within the Trust. As such they are responsible for advising whether unlawful usage under the Act or episodes of absences without leave (AWOL), should constitute a SI. 4.9 Trust Board Secretary The Trust Board Secretary will be responsible for notifying Monitor of appropriate SI and for informing the Associate Directors of Quality and Patient Safety and the Head of Risk Management of such notifications Heads of Service and Line Managers Responsible for: bringing to the attention of their staff the publication of this document providing evidence that the document has been cascaded within their team or department ensuring this document is effectively implemented ensuring that staff have the knowledge and skills to implement the policy and provide training where gaps are identified responsible for exercising local leadership in relation to patient safety, and health and safety of staff and visitors. ensuring that all staff within their teams, including new-starters, are coached in completing the online incident reporting form (see the guidance notes at ensuring all members of their team have easy access to paper incident reporting books or alternative electronic forms for any time when the online incident reporting might become unavailable 4.11 SI Investigation Team The SI investigation team will be experts in the organisation s investigation policies and protocols and will be skilled in good practice, root cause analysis methodologies and techniques. The Head of Risk Management will ensure that the SI investigator allocated will have no Policy No: TW/GO0006/v002 Page 8 of 35

9 4.12 Staff conflicts of interest or appearance of bias in the incident concerned. As part of all SI investigations reference will be made to the current list of Never Events. At any point in an investigation should a SI investigator become aware of any potential negligence, advice will be sought from the appropriate source and the NHSLA advised in line with the current guidance. Responsible for: 4.13 Trust Board adherence to this policy ensuring any training required is attended and kept up to date ensure any competencies required are maintained co-operating with the development and implementation of policies as part of their normal duties and responsibilities identifying the need for a change in policy as a result of becoming aware of changes in practice, changes to statutory requirements, revised professional or clinical standards and local/national directives, and advising their line manager accordingly identifying training needs in respect of policies The Trust Board will be assured that this policy is being delivered and this will give the Board confidence that SI are being handled as required, that the risks associated with SI are being appropriately controlled and that the organisation is learning as a result Quality and Safety Committee The Quality and Safety Committee (Q&SC) is a subcommittee of and accountable to the Trust Board. The Q&SC receives assurance from the Trust s business units that appropriate systems of clinical governance are in place and that patient safety is ensured. The Q&SC must be satisfied that SI are effectively managed, that investigations have been completed in a timely fashion, that all associated risks have been identified, that action plans to remove or minimise identified risks have been delivered and that lessons are learned in order to minimise the risk of similar incidents occurring in the future Executive Management Team The Executive Management Team (EMT) is responsible for ensuring the Trust delivers good quality services that are characterised by clinically effective interventions, a positive patient experience and high levels of patient safety. The EMT will ensure that all necessary structures and systems for handling SI are established, adequately resourced and supported. Policy No: TW/GO0006/v002 Page 9 of 35

10 5. SI Process 5.1 Immediate Management of SI At the earliest possible opportunity after the incident thought to be an SI, the most senior member of staff on duty should contact the appropriate senior manager. The senior manager should alert the appropriate director verbally and follow this with written evidence as to the actions taken so far to make the situation safe as far as reasonably practicable. During normal working hours staff are required to report potential serious incidents immediately to their line manager. Out of hours staff should contact the manager on call via the NELFT switchboard who hold the rotas applicable to the business units and all necessary contact numbers. Contact number for NELFT switchboard is The on-call manager should escalate the incident through the on-call system for the business unit involved. Whether in-hours, or out-of-hours, the responsible director will consider the impact of the incident on the operational management of the service. Should the presence of either a senior manager or a director be indicated, he/she will attend, and will take responsibility for managing the incident, if appropriate and/or necessary. Until such time as the senior manager arrives, the most senior and appropriately skilled person will manage the incident and maintain records of actions taken. The director will determine how to keep the Chief Executive advised. 5.2 Alerting the organisation to an SI All incidents should be reported as soon as is reasonably practical. There is an expectation this should be within the first 24 hours of staff being made aware that an incident has occurred. Wherever possible, all incidents should be reported via DatixWeb. DatixWeb is a web-based incident reporting system, which can be accessed from each and every Trust computer. Guidance notes describing the steps to be followed by a member of staff reporting an incident and, subsequently their manager, can be found at In reporting the incident it is important that the severity of outcome is recorded. This will contribute to the organisation s judgement as to the whether the incident is a SI and if so, the grade of investigation that should apply (see below). The report on DatixWeb must also indicate if the serious incident is a patient safety incident: if it is, the report on DatixWeb must be uploaded to the National Reporting and Learning System (NRLS) within 48 hours. This upload is the responsibility of the Datix administration team. Policy No: TW/GO0006/v002 Page 10 of 35

11 If DatixWeb is not available for any reason, incidents should be reported using electronic incident report forms (IR1 where applicable). A copy of the electronic form is available from the Datix team. 5.3 Alerting external organisations to an SI Alerting external organisations such as commissioners and CQC is via the Strategic Executive Information System (StEIS). To ensure timely and accurate information is shared with external organisations the following alert system is used. This system is contained within the SI flowchart (appendix 1). Pressure ulcer SI will be addressed in section SI 24 hour alert A SI 24 hour alert (appendix 2) should be completed as soon as possible by the appropriate service leads or ward/team managers/leaders. The unique Datix number generated by DatixWeb for every incident will be the reference number used on SI 24 hour alerts. The SI 24 hour alert will be forwarded immediately to the appropriate Managing Director and the Medical Director (MHS) or the Director of Nursing (NEL CS and SWECS). A copy of the SI 24 hour alert will also be sent to the SI team using the secure nelftsi@nhs.net account. The Managing Director with the Medical Director (MHS) or the Director of Nursing (NEL CS and SWECS) will confirm the status of the SI and inform the SI team of this decision. If the SI occurs within a corporate service, the appropriate director will assume the responsibilities of the Managing Director. SI 24 hour alerts once confirmed as SI will be uploaded to StEIS within one working day. The SI 24 hour alert is available via Datix and the procedure to be followed for completing and processing it is held on the intranet at If a SI is suspected, but the situation not yet clear, a SI 24 hour SI alert must be submitted: it can be de-escalated/withdrawn at a later date if necessary SI 72 hour alert A SI 72 hour alert (appendix 3) is completed by the appropriate service leads or ward/team managers/leaders as more information is gathered post incident. This information is forwarded to the appropriate director/managing director by the operational/service director. This will assist in the decision making process regarding the grade of the incident and the level of investigation. The Datix number and StEIS number will be used as references and must be added to the SI 72 hour alert. The SI 72 hour alert will be fully completed within 72 hours of the incident being reported on Datix. Policy No: TW/GO0006/v002 Page 11 of 35

12 5.3.3 De-escalation/withdrawal requests If, at any point in the alert or investigation process it becomes apparent that the incident did not fit the definition of a SI a deescalation/withdrawal request will be made to the appropriate commissioner. De-escalation/withdrawal requests will be completed by the service director and approved by the managing director. De-escalation/withdrawal requests must identify actions taken to maintain patient safety, any identified care or service delivery problems and steps taken to address these issues. 5.4 Grading of SI for the purposes of investigation Once an incident is designated as a SI and reported, the incident grade will be identified by the organisation and agreed by the commissioner jointly for the purposes of determining the investigation and monitoring approach. For grading of incidents, reference should be made to the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation which is available via the following link and the intranet at Grade 1 Serious incident Investigations SI which are graded as a grade 1 will be investigated by an appointed SI investigator Grade 2 Serious Incident Investigations SI which are graded as a grade 2 will be investigated via a panel which is chaired by a Non-executive Director. A member of the SI investigation team will act as an inquiry manager to support the chair Externally appointed investigations Some incidents such as homicides, incidents involving many organisations or those which may impact upon the functioning or reputation of the organisation may appoint an external investigator to lead the investigation. This will be the decision of the Executive Directors. 5.5 Pressure Ulcer SI SI 24 hour alerts Alerting external organisations to a pressure ulcer SI follows the same process as identified above with regards to the completion and approval of SI 24 hour alerts (appendix 4) SI 72 hour alerts The completion of a pressure ulcer SI 72 hour alert (appendix 5) completes two functions. It enables additional information to be gathered and will identify whether the pressure ulcer was Policy No: TW/GO0006/v002 Page 12 of 35

13 avoidable or unavoidable. The decision taken by the director of nursing (NEL CS and SWECS) or the medical director (MHS) regarding unavoidable/avoidable will be forwarded to the SI team within five working days Unavoidable pressure ulcers The completed pressure ulcer SI 72 hour alert will be forwarded to commissioners as a concise investigation report Avoidable pressure ulcers A full investigation will be carried out and this report submitted to commissioners. 5.6 SI Investigations SI investigations The SI investigators will investigate all SI except for specific incidents such as grade 3 pressure ulcers and absences without leave (AWOL). It is acknowledged that involvement in any incident can often be distressing. The duties and responsibilities of management to staff and support available including Occupational Health and staff counsellors is set out in the policy, Supporting Staff Involved in an Incident, Complaint or Claim and the Being Open Policy. All staff who investigating SI will adhere to the Being Open principles. In line with these principles, the service director will nominate a senior manager who relatives may use as a named person they may contact during or after the investigation process. All investigations will follow root cause analysis methodologies and will aim to establish the root causes which led to the incident. The purpose of an investigation is to gain an understanding of the factors that led to the incident (the main contributing factors and/or the underlying or root cause), so that steps can be taken to prevent or minimise the chances of a reoccurrence. The investigation should be undertaken in a way that is proportionate the level of risk represented by the incident Terms of Reference Terms of reference will be agreed based on the information contained within the 72 hour report and following a discussion between the SI investigator and the service director. As a minimum they will contain the following the production of an adequate timeline the review of the SI 72 hour alert and any previous investigation into the report Policy No: TW/GO0006/v002 Page 13 of 35

14 management of any identified risk use of medication (where applicable) presence of an adequate history (where applicable) mental health act and competency issues (where applicable) use of care programme approach (where applicable) Investigation report format All SI investigation reports will be produced using an agreed format. The reports will Action plans 5.7 SI reports Incident date Incident description Actual effect on patient/service Involvement and support of patients and relatives Clear, fact based chronology of events leading up to the incident Care and service delivery problems Contributory factors Root causes Recommendations Action plan (containing the minimum requirements listed below) Anonymised for patient and staff involved in the incident It will be the responsibility of the service directors to address the agreed recommendations contained within the report by an action plan. The action plan will contain as a minimum the following: every recommendation must have a clearly articulated action a responsible person (job title only) must be identified for each action point there are dates for proposed completion of actions description of the form of evidence that will be available to confirm completion A SMART(E) approach to action planning is essential. That is, the actions should be: specific, measurable, attainable, relevant and time-bound and economically viable. Action plans will be set and agreed and responsibility will be held by the operational director and relevant staff and monitored by the relevant quality and safety group of each business unit Approval of SI reports Once the final draft report has been submitted to the service director it is their responsibility to ensure the report is approved by the appropriate managing director and for MHS the medical director, for NEL CS and SWECS the director of nursing. This Policy No: TW/GO0006/v002 Page 14 of 35

15 approval will be evidenced by an electronic signature on the front cover of the report Submission of final reports Grade 1 reports and action plans must be submitted within 45 working days of the incident being entered on StEIS. Grade 2 reports and action plans (excluding homicides) must be submitted within 60 working days. All final reports will be fully anonymised but identifying information will be available to Quality and Safety Committee on request. 5.8 Learning from SI One of the key aims of the serious incident reporting and learning process is to reduce the risk of recurrence. The timely and appropriate dissemination of learning following a SI is core to achieving this and to ensure that these lessons are embedded in practice. Learning from patient safety incidents is a collaborative, decentralized and reflective process that draws on experience, knowledge and evidence from a variety of sources. This will lead to co-production and sharing of safety solutions and improvements, increased visibility to lessons learned and participation in the learning process leading to enhanced patient safety. Final reports will be shared at Leadership Team meetings and dissemination to the teams will be the responsibility of the service directors. Team meetings will have a standing item on the agenda for feedback of reports for discussion around such learning and sharing of expertise. Final reports will be available to all individuals who have given evidence to an investigation. SI investigators will contact those individuals and will inform them of the location of the final report. This notification will be via the most appropriate form of communication, i.e., electronically or via post. An anonymised version of the final report will be uploaded on to the clinical records of the individual involved. A Serious Incident Requiring Investigation (SIRI) briefing will be completed for appropriate SI using the formats on the NELFT intranet site for distribution to service teams to facilitate learning. Themes identified from SI investigation will contribute to the aggregated learning strategy. Where appropriate lessons learnt may be used as part of the appraisal system. 5.9 Duty of candour Any patient harmed by the provision of a healthcare service should be informed of the fact and an appropriate remedy offered. All SI Policy No: TW/GO0006/v002 Page 15 of 35

16 investigators must be honest, open and truthful in all their dealings with service users, patients and the public. Where death or serious harm has been or may have been caused to a patient by an act or omission of the organisation or its staff, the patient should be informed of the incident, given full disclosure of the surrounding circumstances and be offered an appropriate level of support, whether or not the patient or representative has asked for this information. Patients or their representatives must be offered the opportunity to discuss the findings of the SI report. This will be the responsibility of the service director to facilitate and will be included in the action plan. Any copies of final reports sent via the post to patients or their representatives must be sent via recorded delivery Comments or complaints Comments or complaints which describe events amounting to a serious incident should trigger an investigation Coroner s Verdicts Some incidents involving patient deaths need to have a verdict from a coroner. Where this is the case, the SI final report will be submitted within the appropriate timescale and not delayed in order to incorporate the coroner s verdict. It must be made clear in the report that a coroner s verdict is awaited. Once the verdict is available, the Trust will send the verdict (a summary, not the coroner s report) to the relevant commissioner. If the verdict presents issues not covered in the final report, then the trust will revise the SI report in order to incorporate these issues Care Quality Commission As part of the registration requirements arising from the Health and Social Care Act 2008, organisations are required to notify the CQC about events that indicate or may indicate risks to on-going compliance with registration requirements, or that lead or may lead to changes in the details about the organisation in the CQC s register. Reports about SI and deaths are defined in the CQC s guidance, Essential Standards of Quality and Safety. This requirement is met by reporting via the NRLS who will forward relevant information to the CQC Monitor NHS foundation trusts are required to report SI which breach or risk breaching their Authorisation. The Trust Board Secretary will forward the relevant information to Monitor Incidents Involving Work-related Deaths Incidents involving work-related deaths will follow the Work Related Deaths Protocol, an agreed protocol between the Health and Safety Executive, the police, the Crown Prosecution Service and the British Transport Police. This deals with incidents where, following a death, evidence indicates that a serious criminal offence other than a health and safety offence may have been committed. Further guidance on the Policy No: TW/GO0006/v002 Page 16 of 35

17 protocol can be found at and on the intranet at Incidents Involving Serious Case Reviews (SCR) and Safeguarding Issues These have separate specialist management processes and reporting requirements which are set out in the respective Safeguarding Policies. However, these incidents should also be reported on StEIS to ensure that all external reporting requirements are met. The purpose of a SI investigation is to establish system failures and the need to treat the fundamental underlying problem rather than the symptom. The SI team will work in conjunction with the Safeguarding Named Nurse in relation to any serious case review investigations. The investigation of SI can run in parallel with any other internal investigation. A flowchart depicting this is found in appendix 6. Further guidance can be found on the intranet at Incidents involving MRSA blood stream infections NELFT have a PIR Toolkit for use when a MRSA Bacteraemia is detected. Staff are required to be familiar with and follow the PIR toolkit should the need arise. It is considered unacceptable for a patient to acquire an MRSA blood stream infection (MRSA BSI) whilst receiving care in a healthcare setting. This zero tolerance will involve a post infection review for all MRSA BSI and the flow chart (appendix 7) details the processes that NELFT will undertake and the timescales. This post infection review has replaced root cause analysis as a process for investigation of MRSA bacteraemia. The full post infection review toolkit can be found on the intranet at Communication Strategy NELFT has policies and guidance in place for media management following a serious incident. The Head of Risk Management will contact the Head of Communications to ensure that the organisation will effectively communicate that a problem is understood and steps are being taken to put it right and to provide reassurance that the risks of the same thing happening again have been minimised Freedom of Information Act 2000 Information relating to serious incidents including information held on national systems such as StEIS, local databases and internal reports, investigation reports and root cause analysis and other documents, could be subject to a request for disclosure under the Freedom of Information Act SI involving Doctors in Postgraduate Training It is a regulatory responsibility for an employer to notify the London Deanery when a doctor in postgraduate training (DrPGT) on one of their training programmes is involved in a SI. As soon as it becomes known Policy No: TW/GO0006/v002 Page 17 of 35

18 that a DrPGT has been involved in a SI, the relevant Managing Director will inform the Medical Director and the Director of Medical Education, the latter will inform the London Deanery Information governance All information related to the SI procedure will be protected by use of a generic password allocated by the SI team. 6. Glossary of terms 6.1 Strategic Executive Information System (StEIS) StEIS is a database which allows NHS and Department of Health users to report and view SI. It is the method by which all SI are reported to commissioners and strategic health authorities. Depending upon the type and severity of the SI, it automatically generates a date for the submission of final reports. Following an agreement with the Department of Health, CQC can view all reported SI via StEIS. 6.2 Acquired Pressure Ulcer If the pressure ulcer develops 72 hours after admission to the service then it is deemed as being acquired within the provider organisation. 6.3 Inherited Pressure Ulcer If the pressure ulcer is present on admission or identified within 72 hours from entering the service, then it is deemed as not attributable within the provider organisation. 6.4 Avoidable Pressure Ulcer Avoidable means that the individual developed a pressure ulcer whilst on the caseload. 6.5 Unavoidable Pressure Ulcer Unavoidable means that the individual developed a pressure ulcer even though the individuals condition and pressure ulcer risk had been evaluated; goals and recognised standards of practice that are consistent with individual needs had been implemented; the impact of these interventions had been monitored, evaluated and recorded; and the approaches had been revised as appropriate. 6.6 Grade 3 Pressure Ulcer Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. The depth of a grade 3 pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have (adipose) subcutaneous tissue and grade 3 ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep grade 3 pressure ulcers. Bone/tendon is not visible or directly palpable. Policy No: TW/GO0006/v002 Page 18 of 35

19 6.7 Grade 4 Pressure Ulcer Full-thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present. Often includes undermining and tunneling. The depth of a grade 4 pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous (adipose) tissue and these ulcers can be shallow. Grade 4 ulcers can extend into muscle and/or supporting structures (such as fascia, tendon or joint capsule) making osteomyelitis or osteitis likely to occur. Exposed bone/muscle is visible or directly palpable. 7. Implementation process 7.1 Staff will be made aware of any new approved policies/procedures/guidelines via the monthly team brief. Quality and patient safety team will be responsible for ensuring newly approved documents are sent to the communications team in order for them to insert into the team brief. 7.2 All senior managers/heads of service/team leaders need to ensure new policies and procedures are placed on team meeting agendas for discussion. There is an expectation that the team leader will develop local systems to ensure their staff are instructed to read all relevant policies and to identify any outstanding training deficits. 8. Monitoring arrangements 8.1 The effectiveness of this document is monitored and reported through: quarterly PCT contract performance report annual report to Trust board QSC and QSG cycle of business 8.2 Assessment of this policy is set out below Policy No: TW/GO0006/v002 Page 19 of 35

20 Monitoring arrangements table Element Lead Tool Frequency Reporting arrangements Alerting commissioners and CQC via StEIS in time with identified deadlines Uploading of anonymised reports to clinical records Chief Nurse & Executive Director of Integrated Care (Essex) Chief Nurse & Executive Director of Integrated Care (Essex) Audit Annual Head of Risk Management Leadership Teams Audit Six monthly Head of Risk Management Leadership Teams Acting on recommendations and Lead(s) Any changes to the specified element indicated in the first column will be identified in the report and notified to the reporting person/group/committee within a specified time frame Any changes to the specified element indicated in the first column will be identified in the report and notified to the reporting person/group/committee within a specified time frame Change in practice and lessons to be shared The Quality and Patient Safety Team will be responsible for notifying/implementing any changes to the policy within a specified time frame via the policy approval process. Lessons will be shared with all relevant stakeholders. The Quality and Patient Safety Team will be responsible for notifying/implementing any changes to the policy within a specified time frame via the policy approval process. Lessons will be shared with all relevant stakeholders. Policy No: TW/GO0006/v002 Page 20 of 35

21 9. Equality statement This policy reflects the organisation s determination to ensure that all parts of our community have equality of access to services and that everyone receives a high standard of service as a service user, a carer or employee. This policy anticipates and encompasses the Trust s commitment to prevent discrimination on any illegal or inappropriate basis and recognise and respond to the needs of individuals based on good communication and best practice. We recognise that some groups of the population are more at risk of discrimination or less able to access to services than others and that services can often unintentionally put barriers in place that can limit or prevent access. The organisation is continually working to prevent this from happening. 10. Training 10.1 Specific training for identified staff groups will be delivered in line with the current TNA (Training Needs Analysis) which is available on the Intranet. 11. External references Serious Incident Framework; NHS Commissioning Board Independent Inquiry into care provided by Mid Staffordshire NHS Foundation Trust January 2005 March 2009 Policy No: TW/GO0006/v002 Page 21 of 35

22 Comments received Returned, no comments No response List of all stakeholders consulted This form is to be used to capture stakeholder engagement in the policy development process. It helps ensure that key stakeholders have had the opportunity to comment on the policy. It should be completed by the policy author when a policy has been through the stakeholder consultation and is ready to be submitted to the Document Approval Group. You should capture the name of the stakeholder and their response by putting a tick in the relevant box Date sent to Stakeholders: / / Stakeholder name Stakeholder response date: / / Stakeholder title Specialist meetings Meeting name Date Chair s name and title Policy No: TW/GO0006/v002 Page 22 of 35

23 Directorate/Department Policy Title/Service New or Existing Policy/Service Name and role of Assessor Health and Safety Impact Assessment Quality and Patient Safety Serious Incident Policy Existing Date 18/9/13 Ian Kimmett, Head of Health and Safety Please complete the following questions and where answered Yes, please give explanation and/or details of action/mitigation in the comments column. 1 Does this policy or change in No working practice have significant implications for H&S? 2 Are there increased risks to No public, staff or service users? 3 Is there a need to review existing No or undertake new risk assessments? 4 Is there a need to review existing or undertake new Staff Training? No 5 Does this impact on H&S Governance reporting? No 6 If there are implications for H&S No have these been mitigated? 7 Others (please specify) No Yes/No Comments Recommendation Addition detailed risk assessment required: No Policy No: TW/GO0006/v002 Page 23 of 35

24 NORTH EAST LONDON FOUNDATION TRUST INITIAL SCREENING EQUALITY IMPACT ASSESSMENT FORM Equality Impact Assessment Tool The Equality Impact Assessment is a tool that supports the Trust makes sure their policies, and the ways they carry out their functions, do what they are intended to do for everyone fairly. Equality impact assessment (EQIA) is the process by which the Trust seeks to meet its legal requirements in conjunction with the Equality Act 2010 and to narrow the health inequalities that exist between people from different ethnic backgrounds, people with disabilities, men and women (including transgendered people), people with different sexual orientations, people in different age groups, people with different religions or beliefs and people from different social and economic groups. Policymakers must screen all policies for their impact on people from each of the groups listed in point 1 below. If you have identified a potential discriminatory impact of this procedural document which has not been mitigated within the document, please refer it to the Equality and Diversity Manager and arrange to complete a full Equality Impact assessment. Directorate/Department Name of Policy/Service/Function New or Existing Policy/Service/Function? Name and role of Person completing the EQIA Date of Assessment Please complete the following questions Yes/No What/Where is the Evidence to suggest this? 1 Does the Policy/Service/Function effect one group less or more favourably than another on the basis of: Race, Ethnic origins (including, gypsies and travellers) and Nationality Yes The policy and process of investigation is not available in different languages and format and does not meet the needs of patients/carers, whose first language is not English. Gender (males and females) No Age No Religion, Belief or Culture No Disability mental, physical Yes Information is not available in Easy read or other formats. Policy No: TW/GO0006/v002 Page 24 of 35

25 disability and Learning difficulties Sexual orientation including lesbian, gay and bisexual people Married/or in civil partnership Pregnant/maternity leave Transgender reassignment 2 Is there any evidence that some groups are affected differently? Is the impact of the policy/guideline likely to be negative? 3 Is there a need for additional consultation e.g. with external organisations, service Users and carers, or other voluntary sector groups? 4 If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 5 Can we reduce the impact by taking different actions? No No No No No No No No Assessor s Name: Date: Name of Director: This section to be agreed and signed by the Equality and Diversity Manager in agreement with the Equality and Diversity Team Recommendation Full Equality Impact Assessment required: NO YES Assessment authorised by: Name: Date: Policy No: TW/GO0006/v002 Page 25 of 35

26 Appendix 1 SI flowchart Serious Incident Staff member immediately submits a report of the incident via Datixweb. Service lead/manager reviews incident and follows process below. No SI? Yes 24 hours 72 hours Managed locally updated on Datixweb. Patient safety incident data uploaded by QPS team to NPSA via the NRLS End of process Grade O incident de-escalated Operational/service director ensures 72-hour SI report is completed and sent to Managing Director (MD/DoN) MD approves 72-hour report and advises SI team of grade i.e.de-escalation, grade 1 or grade 2 investigation SI admin up-dates StEIS, commissioners notified via StEIS recommending: De-escalation Grade 1 SI investigation or Grade 2 SI Investigation Grade 1 Investigation Raise SI alert using 24 hour alert form Completed 24 hour alert form forwarded to Managing Director and Medical Director/Director of Nursing for approval cc. Service Director Approved 24 hour alert forwarded to SI Team. SI logged on StEIS as a Grade O, commissioner alerted via StEIS Grade 2 Investigation End of process Allocated to SI team for investigation Investigation undertaken: Draft report peer reviewed by SI team, joint review with Ops/Service Director. Ops Director signs off report and sends to MD Allocated to SI Team for Inquiry Manager IM identifies members of panel and ToR agreed Investigation undertaken: Draft report peer reviewed by SI team, joint review with 45 days 60 days Final report to MD and Approval Group for sign off SI Team update StEIS and request closure of incident Action plans delivered Ops Director signs off report and sends to MD Final report to MD and Approval Group for sign off SI Team update STEIS and request closure of incident End of Process Action plans delivered Policy No: TW/GO0006/v002 Page 26 of 35

27 Appendix 2 SI 24 hour alert Datix Number: SERIOUS INCIDENT ALERT To be completed within 24 hours of incident and sent electronically to the Business Unit Managing Director and the Serious Incident Team (nelftsi@nhs.net). Date and time reported Name of service Name of service lead Business unit Name of person/s affected Address DoB / age Ethnic origin Exact location of incident Date of incident Time of incident Medication involved (yes / no) Medical device incident or medical device contributed to the incident (yes / no) RIDDOR reportable (yes / no) Subject to safeguarding (yes / no) Nature and outcome of incident: Immediate action taken: To be completed by person reporting SI Name Position Service Tel/ To be completed by Managing Director Media Interest Partner Agencies anticipated? Notified (e.g. police) Implications for other Trusts? Proceed as SI (yes / no) & Date To be completed by Serious Incident Team Degree of Harm STEIS/Commissioner s (from Datix) Reference Number SI Grading Inaccuracies detected Date recorded on central database These templates should be completed in conjunction with the SI policy Policy No: TW/GO0006/v002 Page 27 of 35

28 Appendix 3 SI 72 hour alert Datix Number:.... SERIOUS INCIDENT 72 HOUR ALERT To be completed within 72 hours of Incident and sent electronically to the Business Unit Managing Director and the Serious Incident Team (nelftsi@nhs.net) Date of incident: Patient/person affected Name Address/work base Telephone number Date of birth Gender StEIS Reference Number: Next of kin Name Relationship Address Telephone Number GP Details Name Practice Telephone number Incident details Service Location Time Who was involved? Details of staff on duty Description of incident Events immediately preceding incident Details of action taken since 24 hour alert Grade of alert (0, 1 or 2) To be completed by person reporting SI Name Position Service Tel/ Approval Date Signature Service Manager/Team Lead Medical Director/Director of Nursing Managing Director Policy No: TW/GO0006/v002 Page 28 of 35