POLICY & PROCEDURE FOR THE MANAGEMENT OF SERIOUS INCIDENTS

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1 POLICY & PROCEDURE FOR THE MANAGEMENT OF SERIOUS INCIDENTS APPROVED BY: South Gloucestershire Clinical Commissioning Group Quality and Governance Committee DATE August 2015 Date of Issue: August 2015 Version No: 2.0 Date of Review:- August 2017 Author: Lindsey Perryman, Head of Governance and Risk 1

2 Document status: Draft Version Date Comments 1.0 August 2013 Approved at Quality and Governance Committee 1.1 March 2015 Policy reviewed by Head of Governance and Risk 1.2 June 2015 Further review following new guidance published 27 March June 2015 Safeguarding section amended by Head of Safeguarding 1.4 July 2015 Amendments following Policy Review Group 2.0 August 2015 Approved by Quality and Governance Committee 2

3 CONTENTS Section Summary of Section Page Cont Contents 3 1 Introduction 4 2 Purpose 4 3 Responsibilities of Staff within South Gloucestershire CCG 4 4 Definition 5 5 Provider Responsibilities 6 6 NHS England Responsibilities 7 7 South Gloucestershire CCG Responsibilities 7 8 Grading of Incidents and Timescales 8 9 Safeguarding 8 10 Investigation of Serious Incidents Closure of Serious Incidents Learning Equal Opportunities/Equalities Impact Assessment Review 11 Appendix Appendix A 12 Appendix B 13 Appendix C 14 Appendix D 15 3

4 1. INTRODUCTION 1.1 The NHS treats over one million patients every day. The vast majority of these patients receive high quality care, however incidents do occur and it is essential that these are highlighted, reported and managed appropriately. 1.2 As a commissioner of healthcare services, South Gloucestershire CCG is committed to making an effective contribution to NHS England s Patient Safety Vision, particularly around developing an excellent reporting culture. 1.3 South Gloucestershire CCG seeks to gain assurance that all commissioned services meet nationally identified standards. This is managed through the local contracting and performance review process. Compliance with the reporting of serious incidents (SIs) is a standard clause in all contracts and service level agreements. 1.4 The role of the CCG is to gain assurance from the provider organisation that incidents are properly identified and reported and then investigated to identify lessons learnt which are used to ensure that the risk of a similar incident happening again is minimised as much as possible. 1.5 In writing this policy, the CCG has reflected on the guidance produced by NHS England in the document Serious Incident Framework 2013 which was originally formulated by the NHS Commissioning Board and Updated by NHS England. 2. PURPOSE 2.1 The purpose of this policy is to identify what an SI is and to describe the process for the reporting and management of these incidents by providers of NHS services commissioned by South Gloucestershire CCG. This will include community services providers, acute trusts, independent contractors and independent providers of NHS services. 2.2 This policy aims to ensure that the CCG complies with guidance formally produced by the National Reporting and Learning System (NRLS) and NHS England. 3. RESPONSIBILITIES OF STAFF WITHIN SOUTH GLOUCESTERSHIRE CCG 3.1 The Chief Officer has responsibility for ensuring that the CCG has the necessary processes and procedures in place to support the effective management of implementation of all risk management and governance policies and delegates the responsibility for the management of serious incidents to the Nurse Director, Head of Quality and Safeguarding. 3.2 The Nurse Director, Head of Quality and Safeguarding has executive 4

5 responsibility for ensuring the necessary management systems are in place for the effective implementation of serious incident reporting for commissioned services. 3.3 The Chief Financial Officer has executive responsibility for ensuring that lessons learned from serious incidents influence quality and safety standards for finance. 3.4 The Head of Governance and Risk is responsible for ensuring that areas identified as high risk are transferred to the CCG Risk Register or the Board Assurance Framework as necessary. 3.5 South Gloucestershire CCG commissioning leads are responsible for ensuring that there are specific references to serious incident reporting in all contracts and the expectations of reporting. 3.6 NHS England is responsible for assuring itself that CCGs have effective systems for serious incident management and for supporting CCGs to hold their providers to account appropriately. 4. DEFINITION 4.1 Serious incidents requiring investigation were defined by the NPSA s 2010 National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. In summary, this definition describes a serious incident as an incident that occurred during NHS funded healthcare (including in the community), which resulted in one or more of the following; Unexpected or avoidable death of one or more people. This includes - 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 required further treatment by a healthcare professional in order to prevent: - The death of the service use; or - Serious harm Actual or alleged abuse, sexual abuse, physical or psychological ill treatment, 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. A Never Event all Never Events are defined as serious incidents although not all necessarily result in serious harm or death 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 5

6 Major loss of confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation 5. PROVIDER RESPONSIBILITIES 5.1 Providers of NHS Funded care that are commissioned by the CCG and who report the occurrence of the incident will take the lead in response. This includes identifying and reporting the incident, conducting an appropriate investigation and forming an action plan to identify key work to prevent reoccurrence of the incident. 5.2 We require providers that we commission to fulfil the following requirements: Collaborate with external scrutiny of investigations and any remedial work required following investigations, including full and open exchange of information with other investigatory agencies such as the police, HSE, Coroner and local safeguarding boards; Publish information about serious incidents including data on the numbers and types of incidents, excluding material that would compromise patients confidentiality, within annual reports, board reports and other public facing documents; Comply with national requirements and guidance in relation to being open with patients or their representatives when things have gone wrong (Duty of Candour) ; Support and enable staff in disclosing incidents to patients and their representatives; Involve patients and families/carers in investigations, sharing findings and providing timely referral for specialist support and guidance where appropriate; Provide relevant guidance and training for staff to help them identify and report and investigate incidents using recognised methodologies (eg RCA); Include the reporting and management of serious incidents as part of staff induction and ongoing training; Ensure timely closure of serious incident cases is enabled by effective communication with the relevant commissioner(s); Ensure that action plans are implemented and that there are mechanisms for board oversight of overdue actions; and 6

7 Regularly review changes made as a consequence of learning from serious incidents to ensure the changes are embedded, sustained and effective. 6. NHS ENGLAND RESPONSIBILITIES 6.1 The role of NHS England is to help provide assurance that both providers and commissioners processes in the relation of Serious Incidents are robust. They are responsible for reviewing trends, analysing quality and identifying issues of concern. They have a responsibility for providing the wider system with intelligence gained through their role as direct commissioners and leaders of the commissioning system. 6.2 In certain circumstances NHS England may be required to lead a local, regional or national response depending on the circumstances of the case. 7. SOUTH GLOUCESTERSHIRE CCG RESPONSIBILITIES 7.1 South Gloucestershire CCG has a named member of staff and a deputy who are responsible for receipt of serious incident reports from providers. This is the Nurse Director, Head of Quality and Safeguarding and the Head of Governance and Risk. 7.2 The CCG will ensure that it specifies clear requirements for responding to serious incidents in contracts with all providers. 7.3 The CCG has access to expert clinical advisers when reviewing serious incidents in by the means of the Nurse Director, Head of Quality and Safeguarding and the Clinical Leads within the CCG. 7.4 The CCG will regularly review serious incidents with providers as part of the clinical quality review process; this will form part of the Clinical Quality Review Meetings. This will also feed into data which will be reviewed by the Quality Surveillance Groups (QSGs) where appropriate. 7.5 The CCG will provide regular reports on serious incidents as part of the Quality Reporting to Quality and Governance Committee 7.6 In addition to this, as culture is an important aspect in terms of incident reporting, the CCG will seek assurance that providers are operating an open and just culture where staff are encouraged to report incidents without fear of inappropriate punitive measures or blame. The CCG will also seek assurance that provider are operating and honest and open culture with patients in ensuring that they are informed when something has gone wrong and also that they are being involved in the investigation process and are informed of the outcome. This can be monitored through compliance with the Being Open Policy. 7

8 7.7 South Gloucestershire CCG has procured South, Central and West Commissioning Support Unit (CSU) to manage the reporting of serious incidents on its behalf. The flow chart depicting this process and outlining the responsibilities and is attached as Appendix A. 7.8 When notification is received that a serious incident has occurred the Nurse Director, Head of Quality and Safeguarding will notify the relevant CCG Lead. Where an incident relates to the Safeguarding of children, the Designated Nurse Safeguarding Children will be notified. 7.9 It is common for an incident to involve more than one commissioner and the CSU will liaise with Bristol CCG and North Somerset CCG to ensure that all parties are notified, a coordinating commissioner is identified and a timescale is agreed A flow chart of the serious incident management process developed by NHS England has been attached as Appendix B. 8 AGREEING THE LEVEL/TYPE OF INVESTIGATION 8.1 The nature, severity and complexity of serious incidents vary on a case by case basis and therefore the level of response should be dependent on and proportionate to the circumstances of each specific incident. The appropriate level of investigation should be proposed by the provider as informed by the initial review. The investigations team and, where applicable, other stakeholders will use the information obtained through the initial review to inform the level of investigation. The level of investigation may need to be reviewed and changed as new information or evidence emerges as part of the investigation process. Within the NHS there are three recognised levels of systems based investigation which are described in the table at Appendix C 8.2 If the CCG agrees that the incident is not a serious incident, they can agree to remove the incident from STEIS. This request will go the Area Team at NHS England to agree. 9 SAFEGUARDING 9.1 It should be noted that the flowchart at Appendix B represents a general process for serious incidents. 9.2 All serious incidents related to safeguarding children or adults should be recorded on STEIS but should follow statutory processes for the investigation, review and closure. Separate processes are required as Serious Case Reviews, Case Reviews, and Domestic Homicide Reviews may involve one or more children, take into account practice that was undertaken many months or years before the incident and should include findings and analysis from every relevant NHS provider. The most effective way to ensure that health organisations assume full accountability is for the NHS Serious Incident process and the statutory safeguarding review process to be aligned. 8

9 9.3 The following safeguarding incidents are reportable on STEIS A Serious Case Review or Case Review related to a child (under 18yrs) undertaken by South Gloucestershire Safeguarding Children Board (SGSCB) A Serious Case Review or Case Review related to an adult undertaken by South Gloucestershire Safeguarding Adult Board (SGSAB) A Domestic Homicide Review undertaken by South Gloucestershire Community Safety Partnership (SGCSP) 9.4 The investigation process for safeguarding serious incidents should follow statutory guidance in Working Together to Safeguard Children HM Government 2015, guidance in the SGSAB Multi Agency Procedures or Statutory Guidance for the Conduct of Domestic Homicide Reviews HM Government There may be two phases to logging a safeguarding serious incident on STEIS: the first report may be done in advance of the decision being made by the SGSCB/SGSAB/SGCSP to undertake a Serious Case Review, Case Review or Domestic Homicide Review (SCR/C/DHR). This is may be by a provider in recognition of the seriousness of the incident. Once a decision has been made to undertake a SCR/CR/DHR a second log which will supersede the first will be reported by the CCG within 48 working hours. 9.6 The description of the incident should be concise but also contain enough information about the circumstances and indicate the potential impact on all the health organisations involved. 9.7 A new STEIS number will be allocated to the case and any previous provider STEIS reports that may have been created will be cross referenced to the new STEIS report and can be closed. The provider initially reporting will become a participating agency for the SCR/CR/DHR, so a Root Cause Analysis (RCA) must still be undertaken. 9.8 If the incident is found to not meet the criteria for a SCR/CR/DHR, the initial report can be closed on STEIS. The CCG should account for why the incident does not warrant further investigation under a SCR/CR/DHR process. NHS England, will review the rationale for the decision not to proceed and if approved, give permission to close the Serious Incident without a report. 9.9 All Providers should produce a RCA which is signed-off by the Safeguarding Executive Lead of the Provider organisation and captures the contributing factors accurately to enable this to be approved and signed off by the CCG and SGSCB/SGSAB/SGCSP panel In cases where two or more health providers have produced a RCA the CCG will consider the requirement to produce an Overview RCA report to ensure the learning across the whole health system is identified and ensure robust 9

10 recommendations and action plans are developed. This Report will be reviewed and formally signed off by the CCG Nurse Director prior to submission to the SGSCB/SGSAB/SGCSP The CCG Head of Safeguarding and SGSCB / SGSAB / SGCSP will advise the CCG contract monitoring manager of the monitoring and oversight required of the implementation of action plans at respective quality assurance sub groups. 10 CLOSURE OF SERIOUS INCIDENTS 10.1 When the provider has submitted a completed investigation and Root Cause Analysis (RCA) with a request to close the incident, this is sent to the CCG for review RCAs are checked, using a standard form, prior to being considered by the CCG to assess whether the RCA meets the criteria. The form is attached as Appendix D The Nurse Director, Head of Quality and Safeguarding is responsible for ensuring that RCAs and action plans submitted are assessed to confirm that they provide adequate assurance in order to close the SI The CCG will make the decision to close based on evidence submitted by the provider. This will include ensuring that the action plan contains action points to address all root causes identified and that they include a named lead for each action and a timescale for completion If the CCG deems that further action or clarification is required this will be communicated to the CSU who will then feed this back to the provider The CCG aims to respond to submitted RCAs within 20 working days and to give providers effective feedback if an SI is deemed not ready for closure. 11 LEARNING 11.1 All organisations are responsible for ensuring that learning from serious incidents is disseminated appropriately. Depending on the outcome it may be useful to share an anonymous version of learning more widely with other organisations if it could prevent harm coming to other patients in the future The CCG will feedback any learning to the Quality and Surveillance Groups (QSGs) and to NHS England if appropriate. 12 EQUAL OPPORTUNITIES/EQUALITIES IMPACT ASSESSMENT 12.1 An Equality Impact Assessment has been completed for this policy and procedure and it does not marginalise or discriminate minority groups. 10

11 13 REVIEW DATE 13.1 This policy and procedure will be reviewed after 2 years, or earlier at the request of either staff or management side, or in light of any changes to legislation or National Guidance. 11

12 APPENDIX A Serious Incident recorded in STEIS by provider Patient Safety Officer receives SI in STEIS inbox and inputs information onto database Patient Safety Officer notifies SG CCG i.e. Nurse Director, Head of Governance and Risk, Quality and Patient Safety Manager and annotates STEIS SG CCG request additional information or assurance / 72 hour report via STEIS Patient Safety Officer monitors RCA completion timescales and liaises with Provider and CCG Patient Safety Officer informs provider RCA investigation report received by Patient Safety Officer Additional information / 72 hour report issued by provider Patient Safety Officer forwards RCA to Patient Safety Manager and annotates STEIS Patient Safety Officer forwards additional information to CCG and annotates STEIS Patient Safety Manager undertakes quality check of RCA against CSU checklist Patient Safety Manager forwards quality check and RCA to Nurse Director and Head of Governance and Risk Nurse Director / Head of Governance and Risk request additional assurances via STEIS Patient Safety Officer informs provider Nurse Director SG CCG agrees closure of SI via STEIS Additional assurances issued by provider Patient Safety Officer Informs provider and annotates STEIS Patient Safety Manager monitors closure of action plan and Duty of Candour requirements and provides update to Nurse Director and Head of Governance and Risk 12 Patient Safety Manager informs Performance Team where Duty of Candour requirements are not met (in accordance with national contract) Key: Provider CSU Quality and Patient Safety Officer CSU Quality and Patient Safety Manager SG CCG Nurse Director and Head of Governance and Risk

13 On-going 20 days* 60 working days or 6 months for independent investigation Support and involve those affected (including patients, victims and their families and staff) Opportunities for feedback and learning identified and information shared Within 3 working days Within 2 working days APPENDIX B Serious Incident Management Process Incident occurs Report on LRMS/ NRLS and to other bodies such as safeguarding lead as applicable Manage in line with local risk management policy No Is it a serious incident? Unknown Review and discuss with commissioner Engage with those involved/affected Yes Report on STEIS Report/notify other stakeholders as required e.g. safeguarding, CQC,TDA etc. Complete initial review and submit to commissioner where possible this should be the provider s lead commissioner who can liaise with others as required. This should be outlined in the RASCI model. Confirm level of investigation required Lead investigator identified. Team established. Terms of reference set. Management plan established Undertake the investigation Gathering and mapping information Analysing information Generating solution Submit final report and action plan Commissioner (with relevant stakeholders) undertakes a review of the final report and action plan and ensures it meets requirements for a robust investigation (see appendix 8). Feedback given to provider (*calendar days) Commissioner closes investigation and confirms timescales/mechanism for monitoring the action plan where actions/improvements are still being implemented. 13

14 APPENDIX C Level Application Product/ outcome Level 1 Concise internal investigation Level 2 Comprehensive internal investigation (this includes those with an independent element or full independent investigations commissioned by the provider) Level 3 Independent investigation Suited to less complex incidents which can be managed by individuals or a small group at a local level Suited to complex issues which should be managed by a multidisciplinary team involving experts and/or specialist investigators where applicable Required where the integrity of the investigation is likely to be challenged or where it will be difficult for an organisation to conduct an objective investigation internally due to the size of organisation or the capacity/ capability of the available individuals and/or number of organisations involved (see Appendix 1 and 3 for further details) Concise/ compact investigation report which includes the essentials of a credible investigation Comprehensive investigation report including all elements of a credible investigation Comprehensive investigation report including all elements of a credible investigation Owner Provider organisation (Trust Chief Executive/relevant deputy) in which the incident occurred, providing principles for objectivity are upheld Provider organisation (Trust Chief Executive/relevant deputy) in which the incident occurred, providing principles for objectivity are upheld. Providers may wish to commission an independent investigation or involve independent members as part of the investigation team to add a level of external scrutiny/objectivity The investigator and all members of the investigation team must be independent of the provider. To fulfil independency the investigation must be commissioned and undertaken entirely independently of the organisation whose actions and processes are being investigated. Timescale for completion Internal investigations, whether concise or comprehensive must be completed within 60 working days of the incident being reported to the relevant commissioner All internal investigation should be supported by a clear investigation management plan 6 months from the date the investigation is commissioned 14

15 APPENDIX D Quality Review of a Root Cause Analysis Investigation Report Serious Incident Investigation Review Template and Contributory Factor Grid The aim of this template and contributory factor grid is to provide guidance and support towards a structured approach of the review of Serious Incident investigation reports as defined in the National Framework for the Reporting and Learning from Serious Incidents Requiring Investigation, NPSA May 2010 and the NHS South of England Process. Application of a root cause analysis approach is recognised as a robust methodology, this template aligns with that methodology. It may be useful as an internal checklist by quality leads in Provider organisations and by commissioners. For ease of completion the responses are primarily designed as Yes No. The last section of the template is set aside for the reviewer as an aide memoire of the review but may also be used to provide feedback or request for additional information or improvement. To support wider identification of key themes and trends the key contributory factors may be captured in the Contributory Factors theme grid. Reviewed by: Designation: Date: SECTION 1 - Details Reporting Organisation: Organisation Type: Incident Type: STEIS Number: Actual Effect on Patient: Lead Commissioner: Speciality: Incident Date: Never Event: Coroner's Inquest Pending: SECTION 2 - Further detail may be provided in the summary at the end of the report Yes No Comments 1. Background and Content Is there a clear overarching description of the events leading up to the incident with detail of the type of care or treatment provided? 2. Details of Investigator / Investigative Team Is the membership of the team appropriate to the incident? This is particularly relevant in the case incidents where specialist advice should be provided e.g. drug incidents? 3. Does the scope and level of the investigation seem appropriate? The report should make clear the point (date) in the patient pathway from which information to support the investigation has been gathered. This should include a review of all relevant contacts. 4. Is there evidence that all relevant information has been gathered to support full exploration of problems? This should align with 3 above. Such information gathering should included relevant patient records, staff rotas, interview transcriptions or statements, referral and discharge letters, diagnosis, police or other 15

16 external agency information as appropriate to the level of complexity of the incident. Policies, procedures and guidance both national and local. 5. Is there evidence of appropriate support and communication for patient and relatives? This should reflect the principles of 'Being Open', Duty of Candour and (as appropriate) include details of how the findings will be shared. 6. Support for staff Is there evidence that appropriate support for staff is in place including where appropriate the application of the Incident Decision Tree, training and development? 7. Chronology / timeline Has a detailed chronology or timeline been included with the report? Any gaps in the chronology or timeline should be satisfied. 8. Does the report identify good practice? It is helpful to reflect where things went well as well as those where problems existed. The learning from good practice should not be lost. 9. Problem identification? Any problems identified in the early stages of the analysis should be clearly listed and noted at the point at which they occurred within the chronology or timeline, some may have little or no impact but will help inform overall learning. 10. Analysis of problems leading to contributory factors? Identification of contributory (or causal) factors is achieved through further in-depth analysis of problems identified (asking and answering 'WHY'). Is there evidence of clear and in depth analysis of problems leading to the identification of contributory factors? (see attached contributory factor grid. 11. Key contributory (causal) factors - Root Cause/s? The investigation should seek to identify the key contributory (causal) factors, root causes that had the most significant impact on the outcome - these should be clearly stated and can be tracked back to the original incident. 12. Recommendations Do the recommendations address the key contributory (causal) factors. root causes as identified? 13. Action plan Is there a clear time framed action plan that includes named individuals or departments responsible for implementation and review? 14. Lessons learned Has the investigation identified learning and stated how this investigation will be shared internally and more widely if appropriate? SECTION 3 - Reviewer Comments This section should be used to provide supportive information for the decisions made above together with any further information required or other relevant details in relation to the incident e.g. referred to independent investigation etc. Yes No Is the reviewer satisfied that the investigation is robust, with in depth analysis thorough identification of any contributory or causal factors root causes and a time 16

17 framed action plan? Has a contributory factor grid been completed and attached to the review? Has the contributory factor grid identified any recurring themes from other similar incidents? If yes, state what action will be taken in summary section below. Summary/Recommendations How will the action plan be monitored and reviewed? 17

18 Contributory (Causal) Factors (Root Causes) Identification Grid Findings from analysis within report Patient Factors Description Task Factors Contributory /Causal Factors/Root Causes Individual Staff Team and Social/Leadership/ Supervision Education and Training Equipment/Resource s Communication Working Conditions/ Environment Organisational/ Strategic The above taxonomy has been taken from the National Patient Safety Agency Root Cause Analysis Taxonomy. The chart should be completed describing the contributory or causal factors where applicable in each of the taxonomy headings above. Some investigation reports may have applied this approach in their analysis in which case these could be cut and pasted to this review. All factors may not be present in all investigations. Those with the most significant impact are generally considered to be key, leading to Root Cause/s where if eradicated or significantly reduced would or may have prevented the outcome. It is these factors that require the most robust actions (solutions) to remove or mitigate any similar incident from occurring. Over time capturing these factors in a structure way should lead to identification of any key themes reoccurring and subsequently to the building of an organisation memory. Checklist adapted from NHS South of England (March 2012) Process for reporting and learning from serious incidents requiring investigation 18

19 Resources National Patient Safety Agency. Seven Steps to Patient Safety Available at: +to+patient+safety%c2%ac Department of Health. The never events policy framework. October 2012 Available at: National Patient Safety Agency. Being open: communicating patient safety incidents with patients, their families and carers. NPSA Available at: National Patient Safety Agency. National Framework for Reporting and Learning from SIRIs Available at National Patient Safety Agency. Three Levels of RCA Investigation - Guidance Available at: Department of Health. Independent investigation of adverse events in mental health services.. Department of Health Available at: dguidance/dh_ National Patient Safety Agency. Good practice guidance Independent investigation of serious patient safety incidents in mental health services Available at NHS Comms Link. Available at: Care Quality Commission. Essential standards of quality and safety. CQC Availalbe at: NHS Connecting for Health. Checklist for Reporting, Managing and Investigating Information Governance Serious Untoward Incidents Available at The NHS Commissioning Board s framework for collaborative commissioning, model agreement and FAQs. Available at NHS England Serious Incident Framework - updated March

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