INCIDENT POLICY (Including near miss and serious incidents)

Policy Details NHFT document reference Version Date Ratified Ratified by Implementation Date Responsible Director Review Date Related Policies & other documents Freedom of Information category

CRM002 Version 1– 27.10.14 4.11.14 Trust Policy Board 4.11.14 Director of Nursing and Quality 4.11.16 See section 10 Policy

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TABLE OF CONTENTS 1. 2. 3. 4. 5.

6.

DOCUMENT CONTROL SUMMARY 4 INTRODUCTION 5 PURPOSE 5 DEFINITIONS 6 DUTIES 8 5.1. Chief Executive 8 5.2. Trust Board of Directors 8 5.3. The Governance Committee 8 5.4. SI Review Committee 9 5.5. Director of Nursing and Quality 9 5.6. All Directors 9 5.7. Heads of Service/General Managers 9 5.8 Datix Manager 9 5.9. Patient Safety Manager/Team 10 5.10. Specialist staff 10 5.11. Medical Director 10 5.12. Managers 10 5.13. ALL Employees 11 POLICY PROCESS 11 6.1. Immediate Action Following an Incident 11 6.1.1. Safety 11 6.1.2. Completion of Incident Forms 12 6.1.3. Immediate management of the Incident and communications 12 6.1.4. Supporting staff 12 6.1.5. Being open 13 6.2. Guidance for Staff Who are Unsure on How to Raise 13 Concerns/External Resources 6.3. Management of Incidents where more than One Department or 13 Organisation is Involved 6.4. Information Governance Incidents and Assessing Severity 14 6.4.1. Assessing the severity of the incident 14 6.4.2. Informing Patients 14 6.5. Child Harm Incidents (significant) 15 6.6. Safeguarding Adults 15 6.7. Deaths and Serious Injuries in Custody 16 6.8. Healthcare Associated Infections 16 6.9. Norovirus Out-Breaks 17 6.10. Screening Incidents 17 6.11. Never Events 17 6.12. Pressure Ulcers 18 6.13. Reporting to Internal and External Agencies 19 6.13.1. Regulation 28 Recommendations 19 6.13.2. Reporting to Commissioners 20 6.13.3. Reporting to the Department of Health 20 6.13.4. Reporting to the Information Commissioner or 20 other Bodies The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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7. 8.

9. 10. 11.

6.14. Records Management and Confidentiality 6.15. Grading of Incidents 6.15.1. Further Grading of Serious Incidents 6.16. Investigations 6.17. Management of Incidents Graded as SIs 6.18. Reporting and Investigating the Most Serious Events in the Organisation and Independent Investigations 6.19. Independent Investigations 6.20. Investigations 6.21. Learning from Incidents 6.22. Risk Management Report covering learning 6.23. Incident Reports to Specialty Leads/Groups/Organisations 6.24. Assurance Reports and Meetings 6.25. Audit of Incident Reporting 6.26. Health and Safety Incidents DUTY OF CANDOUR 7.1 Regulation 20 TRAINING 8.1. Mandatory Training 8.2. Specific Training not covered by Mandatory Training MONITORING COMPLIANCE WITH THIS DOCUMENT REFERENCES AND BIBLIOGRAPHY RELATED TRUST POLICY

APPENDIX 1 - Never Events APPENDIX 2 - Healthcare Associated Infections SIs APPENDIX 3 - Flow Chart for Homicide SIs APPENDIX 4 - Reporting Routes for Grade 2, 3 & Grade 4 Pressure Ulcers APPENDIX 5 - External Stakeholders APPENDIX 6 - Incident Reporting Flowchart APPENDIX 7 - 24 Hour Report APPENDIX 8 - IG Checklist APPENDIX 9 - Guidance on Producing Statements and Statement Format APPENDIX 10 - SI Reporting in Office Hours APPENDIX 11 - SI Reporting Out of Office Hours APPENDIX 12 - Risk Severity Template APPENDIX 13 – NHFT Equality Analysis Tool APPENDIX 14 – Duty of Candour Checklist

21 21 22 22 23 25 26 26 26 26 26 27 27 27 27 27 28 28 28 28 28 29 30 31 32 33 34 35 36 38 39 41 42 43 45 51

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1.

DOCUMENT CONTROL SUMMARY Document Title

Incident Policy (covering near miss and serious incidents)

Document Purpose (executive brief)

To provide a framework for the management of all incidents including near misses and serious incidents, external reporting and a route to improving the safety and quality of services. Review Trust wide

Status: - New / Update/ Review Areas affected by the policy Policy originators/authors Consultation and Communication with Stakeholders including public and patient group involvement

Kate Woodfield – Patient Safety Manager Directors, Clinical Directors, Heads of Service/Locality, all senior managers, Quality Support Team, Commissioners.

Archiving Arrangements and register of documents

The Trust Policy Lead is responsible for this policy and will hold archived copies of this policy on a central register See Appendix 13

Equality Analysis (including Mental Capacity Act 2007)

Training Needs Analysis

See section 7 and refer to the Statutory and Mandatory Training Policy See section 8

Monitoring Compliance and Effectiveness Meets national criteria with regard to NHSLA 2.2 NICE N/A NSF N/A Mental Health Act N/A CQC CQC outcomes 18,19,20 Other N/A Further comments to be Meets statutory requirements and that of considered at the time of the commissioning PCT and SHA. ratification for this policy (i.e. Complies with National Patient Safety national policy, commissioning Agency and Department of Health requirements, legislation) requirements for the management of incidents. If this policy requires Trust Board Trust Policy Board ratification please provide specific details of requirements

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2. INTRODUCTION The collation and analysis of data on incidents and near misses is an intrinsic part of patient safety as it provides valuable opportunities to learn and improve. This policy describes the Trust’s arrangements for reporting incidents of all types and of any significance and the actions expected to manage and follow-up such incidents. This relates to any incidents involving staff, patients and others. This policy supports the Risk Management Strategy and must also be read in conjunction with the Analysis, Improvement and Learning Policy, the Investigation of Incidents, Being Open, Complaints and Concerns and Claims Policies. This policy applies to all Trust services and to all Trust-employed staff, visitors and others who may be affected by incidents or near misses that occur in connection with the Trust’s activities. Staff may choose to report incidents in confidence or anonymously through the Trust’s whistle blowing policy (HR09 Guidance for Staff Raising Issues of Concern). 3. PURPOSE The Trust is committed to supporting and embedding a positive reporting culture within the organisation to enable the organisation to learn when things have gone wrong. An incremental method of grading and investigating reported incidents will be applied using a standard framework outlined in the Analysis, Improvement and Learning Policy. In particular the Trust will:Ensure a “Fair Blame” culture is promoted to ensure that staff are assured that the Trust will have an open and just environment and that it is the Trust Policy. Ensure all incidents are managed in a timely and organised manner. Ensure robust record keeping and reporting mechanisms are in place. Ensure clear lines of accountability and responsibility are identified for all elements of incident management. Ensure that all relevant staff, including bank, locum and agency staff are aware of the communication systems in place for the management of all types of incidents, via induction and training. Establish key communication mechanisms with patients, family and/or carers in line with the Being Open Policy. Ensure all appropriate levels of debrief and support to staff and publicity of lessons learned take place following incidents.

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Ensure all relevant internal and external Stakeholders, Agencies, and Regulatory bodies are engaged, involved and informed in line with National guidelines. Ensure lessons are learned from reported incidents, and take appropriate action to avoid a recurrence, including making changes to practice and/or the environment to improve patient and staff safety where appropriate. Ensure no disciplinary action will result from reporting an incident (including mistakes and near misses), unless there is evidence of  Criminal or malicious activity.  Professional malpractice.  Acts of gross misconduct.  Repeated mistakes.  Or where errors or violations have not been reported. Under these circumstances, disciplinary action will be considered. 4. DEFINITIONS The following definitions detail all types of incidents that must be reported as incidents/near misses: A Hazard is defined as ‘Anything which has the potential to cause harm’. Example: A wet corridor is a hazard, the risk is that a patient or member of staff could slip and fall. An Incident is defined as ‘Any unexpected or unintended event, which gives rise to, or has the potential to produce harm, loss or damage’. Examples: equipment malfunction, breach of confidentiality, violence, abuse and aggression, needle stick injury, slips, trips and falls, medication error, failure of a medical device, communication failure, delay in risk assessment. A Near Miss is defined as the situation ‘Where an incident was prevented resulting in no harm, but had the potential to harm’. Example: Medication was about to be administered to a patient when it was realised that it was the wrong patient. RIDDOR refers to the ‘Reporting of Injuries, Diseases and Dangerous Occurrences Regulations’ (1995) and requires employers and others to report accidents and some diseases that arise out of or in connection with work. Mandatory reportable incidents include:  Deaths  Major injuries (including as a result of physical violence)  Injuries lasting more than 5 days (where an employee or self employed person has an accident and the person is away from work or unable to work normally for more than three days)  Injuries to members of the public where they are taken to hospital  Work related diseases and dangerous occurrences (i.e accidental release of any substance which may damage health).

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A Serious Incident (SI) is defined as:  An incident (including healthcare associated infections) where care management failures have been identified, which resulted in serious injury, major permanent harm or death (or the risk of) to the patient as a result of NHS funded healthcare.  An accident occurring on NHS premises that results in serious injury, major permanent harm or death (or the risk of) to a member of staff, contractor or member of the public.  Any event that might adversely impact on the delivery of service plans and/or may reflect a serious breach of standards or quality of service.  An allegation of abuse to a patient by staff.  Serious assault of staff.  Significant damage to NHS assets.  Involvement of external investigation agencies such as Care Quality Commission (CQC) or Health and Safety Executive (HSE) on a reported incident.  Serious harm involving medical devices or medication errors including discrepancy in the controlled drug stock records which has not been resolved and misuse of controlled drugs by staff.  Raised severe criticism by an external body e.g. H M Coroner, Parliamentary and Health Service Ombudsman, Care Quality Commission in relation to an incident.  A ‘Serious, largely preventable patient safety incident that should not occur if the available preventative measures have been implemented’; otherwise known as a Never Event (see Appendix 1).  ‘Any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals’.  Healthcare associated infections that fall within the SI definition provided within Nene CCG SI Policy (see Appendix 2).  Allegation of homicide committed by a patient, an information governance incident or any other incident that falls within the SI definition provided within NHS East Midlands Policy for Managing and Investigation the Most Serious Events in The Trust Services (Including Commissioning Independent Investigation) (see Appendix 3).  Pressure Ulcers at Grade 3 or 4 (see Appendix 4)  Healthcare issues identified in the reporting of a child death, significant harm or alleged abuse.  The admission of any child under the age of 16 to an adult Trust mental health ward (those children aged 16-18 should be reported through the safeguarding route only). The above are examples and not a definitive list. The definition provided by Nene CCG (Commissioners) should also be considered and this describes any incident that has occurred in NHS funded services and care resulting in unexpected or unavoidable death, serious harm, a providers inability to continue to deliver healthcare services, allegations of abuse, adverse media coverage and/or one of the core set of Never Events. For further guidance contact the Patient Safety Manager.

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Examples: Loss of an unencrypted memory stick holding multiple patient data, MRSA bacteraemia, apparent suicide, alleged abuse of a patient, allegation of homicide committed by a patient. A suicide or suspected suicide is defined as death where:  There is obvious evidence or strong suspicion of self harm, or  The above does not apply initially but emerges later from an investigation of the case, or  Where the H M Coroner’s conclusion is suicide, or where the narrative indicates that the individual took their own life. Pressure ulcer A localised injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear. Root Cause Analysis (RCA) is a methodical approach to investigations and is endorsed by the National Patient Safety Agency (NPSA) who recommend that NHS organisations use this systematic way of investigation to seek to look beyond individual actions and identify if there have been any systemic failings within the organisation that need to be addressed. RCA also promotes the identification of learning, the monitoring of and assurances that should be sought on actions taken to improve safety (see Analysis, Improvement and Learning Policy). NHFT - Northamptonshire Healthcare NHS Foundation Trust 5.

DUTIES

5.1    5.2      

Chief Executive will have: Overall responsibility for the implementation of this policy. Give approval for the quality assurance on all SI investigation reports prior to submission to external stakeholders and feedback to those affected by the SI. Chair the SI Review Committee. Trust Board of Directors will: Review reports on SIs on a bi-monthly basis. Receive exception reports on key risks on a bi-monthly basis. Delegate responsibility for consideration of risk management reports that contain incident information to the Governance Committee. Receive and consider any investigation reports covering the most serious incidents meeting the criteria set by Nene CCG and to receive regular updates on any subsequent action plan. Consider any independent investigation reports conducted. Commit to the requirement to follow the Being Open requirements as determined by the NPSA.

5.3 The Governance Committee will: Consider patient safety reports to incident management and learning.

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5.4 SI Review Committee will: Seek assurance on the management of SIs in the organisation and any subsequent learning. 5.5 Director of Nursing and Quality will: Ensure that this policy is implemented through robust systems and processes and that there are effective reporting and monitoring processes in place. 5.6          

5.7   

5.8 

All Directors will: Ensure that internal and external reporting requirements are met. Ensure that all incidents are investigated according to the severity of the incident (please refer to the Investigation Policy). Decide whether an incident fulfils the criteria for a SI and appoint an investigation lead/team who is trained appropriately and will take overall responsibility for ensuring the incident is managed in line with this policy. Work closely with the Patient Safety Manager in the quality assurance process of checking SI investigation reports and action plans. Review and sign all completed SI investigation reports and action plans and submit to the Patient Safety Manager. Ensure that effective analysis and learning systems are in place within their care pathway and that assurance and monitoring takes place. Ensure that their care pathway follows ‘Being Open’ with all those affected by an incident, together with effective support mechanisms for staff. Consider incident and aggregated data in the identification of risks and address risks through risk reduction measures and to improve quality of services. Ensure that staff attend training to comply with the requirements of this policy according to the training needs analysis shown in the Trust’s Statutory and Mandatory Training Policy. Adhere to policies of commissioning organisations, taking responsibility for producing reports that meet the required timescale and to report to the Trust Board of Directors on investigation findings and learning. Heads of Service/General Managers will: Have systems and processes in place to deliver on the required duties of directors as listed above. Ensure that all staff within their area are aware of and understand this policy. Ensure that all incidents are reported and investigated according to the severity of the incident, working closely with Directors and the Patient Safety Manager for SI investigations. Datix Manager Review all incident forms through a weekly audit and ensure entry onto the Trust’s risk management database is correct.

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   

Quality assure the reporting and approach to grading of incidents and provide feedback reports to managers where there are issues of concern, offering support and re-training. Provide training and support to staff on all aspects of incident management. Produce bi-monthly (and at other requested intervals) incident reports for Directors for analysis. Issue notification of SIs to relevant directors and lead staff providing guidance on internal and external deadlines and requesting statements (where a death has occurred) from key staff.

5.9 The Patient Safety Manager / Team  Monitor the performance management of SIs on a weekly basis working closely with the Directors.  Work with and support care pathway operational groups that consider incidents, providing incident information as required.  Have co-ordinated and centralised records and files on incidents that contain all documents relating to the reporting, investigation, learning and communication with external stakeholders and others.  Co-ordinate the SI Review Committee.  Ensure that external reporting responsibilities are met by the organisation by liaising with the various leads shown in Appendix 5. 5.10 

Specialist staff Advise and assist in the reporting, investigation and actioning of incidents relevant to their role. Specialist staff can include; the Health and Safety Manager, Patient Safety Manager, Manual Handling Lead, Infection Control Lead, Safeguarding Lead, Fire Officer, Occupational Health Lead, Local Security and Management Specialist, Emergency Planning Lead etc.

5.11  

Medical Director Ensure that medical staff are fully aware of this policy. As Caldicott Guardian, ensure that effective systems are in place to maintain the security of identifiable data.

5.12 

Managers Ensure that they and the staff they are responsible for complying with the content of this policy. Ensure that staff have access to training in the form of local induction covering incident reporting and further training identified, e.g. root cause analysis training (see Investigation Policy). Ensure that staff report all incidents effectively and that where necessary, local investigations are undertaken and learning identified and implemented. Consider incident data in risk assessments undertaken as part of the Risk Register process. Grade incidents and approve them before submission to the risk management database, Datix.

   

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    



5.13        

6.

Participate and ensure staff participation in any incident investigation, including SIs (refer to the Trust Investigation of Incidents, Complaints and Claims Policy). Collate statements from staff within 24 hours (where possible) of reporting any SI and submitting original statements to the Patient Safety Manager (in the event of an unexpected death). Secure any paper based clinical records for any patient involved in an SI. Support staff involved in and/or affected by an incident in line with the Supporting Staff Policy. Ensure that lessons learned are fed into local forums and across the pathway. Review trends on a regular basis and where necessary, develop action plans to reduce likelihood (please refer to the Analysis, Improvement and Learning Policy). Ensure a regular reporting mechanism exists with line manager, Matron or Head of Service. ALL Employees Attend the required mandatory training relevant to this policy. Read and comply with the content of this policy. Report all incidents that they are involved in or witness/discover. Not communicate directly with the media relating to incidents and should direct all enquiries from the media to the Trust Communication Lead or the Chief Executive’s office. Ensure that they are familiar with the out of hours procedure for reporting a SI. Comply with the requirements of the Being Open Policy in relation to incidents in communicating incident information to those affected. Participate in implementation of learning from incidents in line with the Analysis, Improvement and Learning Policy. Act on and report in accordance with this policy any incident that is brought to their attention by a patient, visitor or contractor. POLICY PROCESS

6.1 Immediate Action Following an Incident This guidance is for all staff. It also relates to any manager taking responsibility for the local investigation of an incident and any person identified as the investigating manager following an SI in accordance with the Investigation Policy. An incident reporting flow chart that includes timescales is attached at Appendix 6. 6.1.1 Safety The safety of patients, staff and the public must be priority. Any member of staff present when an incident is discovered must take immediate action within their competency to reduce risks and maintain safety of all. In such circumstances, this may involve the disturbance of the area/possessions where a death has occurred.

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The manager of the area involved in the incident must ensure the environment is made safe to prevent any re-occurrence and deal with the immediate needs of patient/visitor/staff. 6.1.2 Completion of incident forms Every incident must be reported on the Trust’s Incident Report Forms by way of DatixWeb Database. A paper form may be used for those staff who do not have access to DatixWeb. Supplies of the incident forms are available from the Datix Manager and training on reporting incidents via DatixWeb is available from the Datix Manager and should also be part of local induction for new members of staff. Incidents should be reported within 24 hours of becoming aware of the event. This includes all types and grades of incidents including SIs. All sections of the form should be completed covering immediate post-incident actions. Where the incident meets the serious incident grading criteria, a 24 hour report form should be completed by a senior manager and forwarded to the Patient Safety Manager within 24 hours of the incident occurring or from being aware that a serious incident has or has potentially occurred (see Appendix 7 for the template) 6.1.3 Immediate management of the Incident and communications The senior member of staff in charge of the service area should be informed immediately. It is their responsibility to ensure that the incident has been dealt with and any necessary further reporting of the incident takes place. This includes ensuring that the next of kin have been contacted, where necessary, and an incident form has been correctly completed so that reporting to senior managers and Directors can take place if appropriate. If the incident is an SI, communications to patient(s)/ relatives/ carers will be managed by the Director and in the Director’s absence, delegated to the Head of Service. Monitoring of ongoing communication with staff/ patients/relatives/carers will be undertaken by the Director and shared with the Patient Safety Manager for assurance purposes of Being Open. Any patient and those involved, including staff, in the incident should be supported and given an explanation of the incident, its consequences as far as is known, the treatment available and what immediate actions are necessary to minimise further risk or injury. This communication should take place as soon as possible. The public/media should not be given information until the service user and those immediately involved in the incident have been communicated with. The Chief Executive with assistance from the Communications Lead will determine when communication to the public/media can be made. This will always be through the Chief Executive/Communications Lead and contacts from the public and/or media should be directed to them immediately. 6.1.4 Supporting staff The manager of the area will ensure that those involved in or affected by incidents are supported following an incident. The Trust values its staff and recognises that they are its most valuable resource. In support of this principle, all staff members involved or affected by a traumatic or stressful incident should be offered support from their line manager immediately or as soon as practically possible. The appropriate manager will The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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need to assess the needs of the staff involved and where necessary implement a plan to assist in their recovery from any harmful or stress related reactions. Where an incident of assault to a member of staff has occurred, the member of staff is also required to notify the Local Security Management Specialist (LSMS). This is automatically sent as a notification to the LSMS completed when an incident is reported via Datixweb. 6.1.5 Being open The manager of the area or the staff member directly involved in an incident should comply with the requirements of Being Open as determined by the National Patient Safety Agency (NPSA). Staff should refer to and comply with the Being Open Policy in terms of communicating and supporting individuals. 6.2 Guidance for staff who are unsure on how to raise concerns/external resources The Trust recognises that some staff may find it stressful or traumatic to raise concerns about an event and that they may prefer to speak with an organisation outside of their own initially. Line Managers should ensure that staff are aware of HR009 - Guidance for Staff Raising Issues of Concern and also staff should be made aware of the Whistleblowing Helpline. NHS staff who have concerns and are unsure how to raise them or would like free, independent and confidential advice are able to call the new helpline provided by the Royal Mencap Society. The helpline is also open to employers for good practice advice. The new number is 08000 724 725. The helpline is available weekdays between 08.00 and 18.00 with an out of hours answering service on weekends and public holidays. Public Concern at Work (PCaW) remain a independent whistle blowing charity offering advice, however they are no longer commissioned by the Department of Health to provide the national NHS helpline. Open disclosure by staff will be treated with confidence and support will be provided to staff who openly disclosure information connected to any incident or potential incident. 6.3 Management of incidents where more than one Department or Organisation is involved Where an incident is discovered within a department, it is the responsibility of staff to report it in line with current NHFT policy. However, the incident may have occurred in another department, and where this is the case, you must inform your line manager who will liaise with the other department to ensure that appropriate actions are identified to reduce the likelihood of the incident recurring.

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Where an incident is discovered which may have originated in another organisation who were involved in the care of the patient, the Patient Safety Manager should be contacted so that the appropriate stakeholders can be informed and involved in the investigation. For SI’s and root cause analysis investigations joint working will take place and the process will be managed and co-ordinated by the NHS organisation that has greater involvement in the provision of care to the patient. The Patient Safety Manager will coordinate any joint working (for investigation guidance please refer to the Investigation Policy). 6.4

Information Governance Incidents and Assessing Severity

6.4.1 Assessing the severity of the incident The immediate response to the incident and the escalation process for reporting and investigating will vary according to the severity of the incident. The following matrix should be used to categorise the incident according to the likely consequences, with the most serious being categorised as a 5. An IG checklist for reporting incidents of this type is attached at Appendix 8. 0 No Significant reflection on any individual or body. Media interest very unlikely.

Minor breach of confidentiality. Only a single individual affected.

1 Damage to an individual’s reputation. Possible media interest, e.g. celebrity involved Potentially serious breach. Less than 5 people affected or risk assessed as low e.g. files were encrypted

2 Damage to a team’s reputation. Some local media interest that may not go public

3 Damages to a services reputation/low key local media coverage

4 Damage to an organisations reputation /local media coverage

5 Damage to NHS reputation/Na tional media coverage

Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected

Serious breach of confidentiality e.g. up to 100 people affected

Serious breach with either particular sensitivity e.g. sexual health details or up to 1000 people affected

Serious breach with potential for ID theft or over 1000 people affected

6.4.2 Informing Patients Consideration should always be given to informing patients when person identifiable information about them has been lost or inappropriately placed in the public domain. Where there is any risk of identity theft it is strongly recommended that this is done. The Being Open Policy should be referred to. For further guidance on the management of information governance incidents please refer to the Information Governance Incident Procedure.

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6.5 Child harm incidents (significant) Where a child has been significantly harmed but not died as a result of, the following considerations need to be explored as to whether the incident is a SI or not. Has the harm occurred on NHS premises, as a result of NHS funded care, or caused by the direct actions of healthcare staff? If no to all the above, it’s useful to consider whether or not the child has been in receipt of healthcare within the last 12 months. If so the case will need to be reported as an SI as well as to the LSCBN. Any child under the age of 18 admitted to an adult mental health ward qualifies as an SI (ref page 16 of the NPSA Framework information resource). Allegations of serious abuse (physical / mental / sexual) against healthcare staff who work with children must be reported as a SI and to the designated safeguarding person. 6.6 Safeguarding Adults A vulnerable adult is someone over the age of 18 years in need of services by reason of mental or other disability who is unable to take care of or protect themselves against harm or exploitation. All incidents of abuse including neglect to a vulnerable adult are notified through Safeguarding Adults procedures. In the following circumstances, the case needs to be reported as an SI as well as through Safeguarding Adults procedures where: -

a vulnerable adult dies (including death by suicide) and abuse or neglect is known or suspected to be a factor in the vulnerable adult’s death a vulnerable adult has sustained a potentially life threatening injury through abuse or neglect; serious sexual abuse; or sustained serious and permanent impairment of health or development through abuse or neglect And/or where:

-

-

the harm occurred on NHS premises as a result of NHS funded care caused by the direct actions of healthcare staff the case gives rise to concern about the way in which healthcare staff and services have worked together to safeguard vulnerable adults consideration where healthcare delivered within the last 12 months is implicated in the concern

Cases of death or significant harm, the case may also be investigated as a Serious Case Review under Safeguarding Adults procedures. The interagency decision to investigate as a SCR should not delay the investigation as an SI. The SI report will form the basis of any SCR individual management report. Guidance for staff on the investigation of safeguarding related serious incidents should be referred to within the Investigation Policy.

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6.7 Deaths and Serious Injuries in Custody All deaths in custody (including those that appear to be natural causes) and near misses, such as serious self harm, attempted suicide, and serious failures within healthcare services must be reported as a Serious Incident by services to the Patient safety Team and relevant Director and recorded on STEIS. In addition, deaths of offenders who were known to healthcare services and died after release of up to 3 months must also be reported and investigated. It is not suggested that these are subject to a commissioned clinical review but should be systematically investigated by way of a succinct clinical review to identify if any learning can be identified to prevent similar incidents. The relevant Commissioner will ensure that a death in custody incident is subjected to a clinical review by an independent investigator. This must be a clinician, with skills in Root Cause Analysis (RCA) techniques. This clinical review produced by NHFT will contribute to the Prison and Probation Ombudsman (PPO) Investigation and should be completed in accordance to the PPO timescale of 10 weeks. The Commissioner will review the clinical review to ensure it has been conducted in a robust manner and obtain assurances from the Prison healthcare staff that any recommendations outlined have been implemented. All other serious incidents reported for those patients in custody will be investigated in line with the Trust’s Investigation Policy with the level of investigation determined once the incident has been graded within the SI categorisation (e.g. level 0, level 1 or level 2). 6.8 Healthcare Associated Infections All identified cases of MRSA bacteraemia need to be reported as an SI. Clostridium difficile cases need reporting as an SI as follows: -

-

Classified as 1a and 1b on the death certificate where it is clear Clostridium difficile has made a significant contribution to cause of death. The Consultant responsible for managing patient care at time of patient’s death is accountable /required to decide whether Clostridium difficile was a contributory factor of death). Cases where a serious complication including colectomy arise due to Clostridium difficile

All the following Hospital and Community based outbreaks should be reported as SIs: -

-

Result in high mortality for staff, patients or the community Involve highly virulent and transmissible organisms Require control measures that have an impact on the care of other patients, including limitation of access to healthcare services or where business continuity will be affected Are sufficiently serious to require the convening of an incident team and/or are transmissible with an impact on staff, patients or the community

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-

Infected healthcare worker or patient incidents necessitating consideration of look back investigation (e.g. TB, vCJD, blood borne infections)

Significant breakdown of infection control procedures with an actual or potential for cross-infection (e.g. release of products from a failed sterilisation cycle, contaminated blood transfusion). 6.9 Norovirus Out-Breaks Either of the following two triggers will result in the organisation reporting an SI: 1. 2.

One or more wards closed due to norovirus. An outbreak meeting has been called a report of the full outbreak of all areas affected needs to be submitted within 45 working days SI being reported.

6.10 Screening Incidents National screening programmes are public health interventions, which aim to identify disease or conditions in defined populations in order to either reduce morbidity or mortality. Screening programmes are sometimes made complicated because the activity of screening often takes place within pathways across several organisations. Often there are a wider range of organisations involved including those at a national level and organisations who externally quality assure the screening programmes. Therefore the management of an SI becomes complicated with the potential to cause delay or confusion. For this reason a policy for managing serious incidents in screening has been developed by the regional Directors of Public Health. The policy states that a screening SI is: An actual or possible failure at any stage in the pathway of the screening service, which exposes the programme to unknown levels of risk that screening, and assessment or treatment of screen-positive people have been inadequate, and hence there are possible serious consequences for the clinical management of patients. The level of risk to an individual may be low, but because of the large numbers involved the corporate risk may be very high. 6.11 Never Events Never events are serious, largely preventable patient safety incidents that should not occur after the preventable measures have been implemented. The Never events Framework -2013/14 (updated December 2013) provides the list of never events Please also see the detailed list of Never Events and links with Trust’s services at Appendix 1. NHFT must ensure further information is provided to commissioners following the initial reporting of any Never Event. The Patient Safety Manager will ensure that the following information is obtained from the investigation team and pathway director within the first few days of reporting the Never Event covering any staff involved:

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-

When was their last appraisal Did it the appraisal include (relevant to the issue) adherence to the WHO Surgical Checklist Whether this is the first issue with which the individual has been involved What remedial or disciplinary action has/ is being considered or has been taken to that point Referral to a professional body - GMC, NMC, HPC. Status of that referral to date.

This information will form part of a 72 update to commissioners. The final investigation report must also include a full update on this issue (refer to Investigation Policy). 6.12 Pressure Ulcers Pressure ulcers of grade 3 and 4 are to be reported as serious incidents. Guidance on reporting details connection with pressure ulcers can be accessed via Nene CCG Policy for the Reporting and Management of Serious Incidents or from the Risk Management Team. For further guidance please refer to Appendix 4. There are four categories of pressure ulcers from 1 to 4. Thermometer data collection and triangulation with serious incidents for those ulcers at grade 3 and 4 will take place between the Patient Safety and quality teams. The NHS Safety Thermometer tool used by clinicians in the Trust feeds into assurance mechanisms with the quality support team. Pressure ulcers are graded ‘avoidable’ and ‘unavoidable’. Avoidable means that the person receiving the care developed a pressure ulcer and the provider of care did not do one of the following; evaluation the person’s clinical condition and pressure ulcer risk factors; plan and implement interventions that are consistent with the persons needs and goals, and recognised standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate (Department of Health). Unavoidable are those patients who are at the final stages of end of life and the intervention needs to be balanced against their comfort and dignity and in all cases where services report unavoidable pressure ulcers at levels 3 and above, these will be subject to clinical review by the Pressure Ulcer Lead Nurse and Patient Safety Manager for assurance. This will also be shared with Commissioners. Staff are required to report ‘inherited’ pressure ulcers which is an ulcer defined when the patient has come into the care of the Trust or developed within 72 hours of coming into the Trust’s care. An acquired (new) pressure ulcer is defined as being a pressure ulcer that developed 72 hours or more after the patient comes into the care of the Trust.

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6.13 Reporting to internal and external agencies Upon receipt of the incident report the Patient Safety Team will notify appropriate internal and external stakeholders, agencies and Regulatory Bodies as appropriate. Please refer to Appendix 5 detailing the reporting arrangements to internal and external agencies. The Patient Safety Manager will be the point of contact for staff queries on any reports to H M Coroner in preparation for inquests and other external contacts such the National Health Service Litigation Authority (NHSLA), H M Coroner and Trust appointed solicitors. Information to these agencies will be through a co-ordinated and supportive approach by the Patient Safety Manager who will work in liaison with the responsible Director and Chief Executive. Coroners are able to make Regulation 28 Recommendations where systematic failings have been identified and where a recommendation is necessary to ensure learning has been put in place to avoid similar incidents occurring. Organisations have 56 days to respond to Regulation 28 recommendations and where NHFT has received such a recommendation, the director of the relevant service will provide a written response, providing assurance of completion of learning actions within this timescale, to H M Coroner, through liaison with the Chief Executive. 6.13.1 Regulation 28 Recommendations will also be monitored by the Commissioners and assurance of learning actions will be shared with them by the Patient Safety Manager. 

Under the Care Quality Commission (CQC) „Guidance about compliance:



Essential standards of quality and safety‟, NHS Trusts are required to submit notifications about different incidents and events that relate directly to certain outcomes under the CQC guidance, these are as follows: Outcome 8 – Infection Control



Outcome 18 – Notification of death of a person who uses services



Outcome 19– Notification of death or unauthorised absence of a person who is detained or liable to be detained under the Mental Health Act 1983.



Outcome 20 – Notification of other incidents

The reporting to the CQC is managed and co-ordinated by the Quality Support Team.

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6.13.2 Reporting to Commissioners The Trust has to report all serious incidents (SIs) in relation to personal identifiable data, i.e. all incidents rated as 1 – 5, to Commissioners through the patient Safety Team within 24 hours of the incident being identified. The following information should be provided in each case:  A short description of what happened, including the actions taken and whether the incident has been resolved;  Details of how the information was held, for e.g. paper, memory stick, disk, laptop, etc;  Details of any safeguards such as encryption that would mitigate the risk;  Details of the number of individuals whose information is at risk;  Details of the type of information, for e.g. demographic, clinical, NHS number, etc;  Whether a) the individuals concerned have been informed, b) a decision has been taken not to inform or c) this has not yet been decided  Whether a) the Information Commissioner has been informed, b) a decision has been taken not to inform or c) this has not yet been decided  Whether the SI is in the public domain and the extent of any media interest and/or publication If there is any doubt as to whether or not an incident meets the SI reporting criteria, the Trusts’ Patient Safety Manager will liaise with the Commissioners for clarification. The Trust has to keep the Commissioners informed of any significant developments in internal/external investigations, as appropriate. The Commissioners should continue to keep a watching brief on developments including following up further details/outcomes of the incident. The Trust’s communications team should contact the Commissioners Communications team immediately if there is the possibility of adverse media coverage in order to agree a media handling strategy. Where necessary, the Commissioners Communications team will brief the Department of Health Media Centre. 6.13.3 Reporting to the Department of Health Commissioners will be responsible for notifying the Department of Health of any category 1-5 incident reported by forwarding details to the appropriate dedicated mailbox established within the Department of Health. Once an incident has been reported to the Department of Health any subsequent details that emerge relating to the investigation and resolution of the incident should also be supplied. The Department of Health will review the incident and determine the need to brief Ministers and/or take other action at a national level. 6.13.4 Reporting to the Information Commissioner or other Bodies. The Information Commissioner should be informed of all Category 1-5 incidents. The decision to inform any other bodies will also be taken, dependent upon the circumstances of the incident, e.g. where this involves risks to the personal safety of patients, the National Patient Safety Agency (NPSA) may also need to be informed. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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6.14 Records Management and Confidentiality It is essential that incident forms are completed accurately and that all relevant information relating to the incident is documented. The information recorded on the incident form should be factual and accurate; supposition, inappropriate opinion or unverifiable facts should not be recorded. Where a potential Serious Incident (SI) has occurred, it is essential that accurate and contemporaneous information is collated at the time, ensuring that all facts are captured and not forgotten. This should include statements from staff, which should ideally be taken within 24 hours of the incident. Appendix 9 provides guidance and the format to be used by staff producing statements. Appendices 10 and 11 provides guidance on immediate actions that should take place in the event of a potential or actual SI occurring. Incident forms can contain sensitive patient and staff related information. As such, the Trust has a duty of care in relation to confidentiality and a legal obligation in relation to the Data Protection Act 1998 to ensure that all such sensitive personal data is stored in a secure location. Incident forms are not considered part of the patient’s medical records and as such should not be stored with them. However, incident forms can become subject to external scrutiny via access to data requests, freedom of information requests (Freedom of Information Act 2000), H M Coroner Inquests, complaints, claims etc. As such, it is important to ensure that the incident form contains details of the actual incident; however any information regarding the care of the patient during and after the incident should be made in the body of the medical records, including any communication with relatives. The recording of the incident form number within the medical records can often be helpful. The Trust has a legal obligation to retain paper versions of incident forms for a period of 10 years; incident forms relating to the under 18’s should be retained for a period of 25 years. Compliance with this requirement is undertaken centrally by the Risk Management Department and as such, all other paper copies of the incident form may be destroyed and disposed of via the confidential waste after they have been dealt with locally. Electronic versions of the incident forms via DatixWeb are retained indefinitely in the Datix Database. 6.15 Grading of Incidents Grading incidents or risk evaluation is a key component of the risk management process. Incidents need to be graded for severity in order to establish the level of investigation and the appropriate action required to reduce or eliminate the risk. Grading or risk evaluation should be undertaken locally within the reporting area so that teams can decide upon the level of investigation that is required. Guidance on the grading of incidents is aligned to the model used by the NPSA and throughout the Trust for all Risk Management processes and can be found at Appendix 12. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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6.15.1 Further grading of serious incidents This section should be read in conjunction with the Investigation Policy. The grading of SIs reported externally to the Commissioners will be based on the following criteria to determine the level of investigation:  Grade 0 A grade 0 incident is reported for notification only. This is an incident that is serious in nature but does not require a full root cause analysis (RCA) investigation. A succinct local investigation will be produced and will be shared with commissioners who will confirm that no further RCA investigation is necessary as the learning is immediate.  Grade 1 Those incidents that require a comprehensive root cause analysis. Examples: mental health deaths in the community where self harm is suspected or attempted suicides as inpatients, Healthcare Acquired Infections (HCAI) outbreaks, avoidable/unexplained deaths, grade 3 or above pressure ulcer, poor discharge planning causing harm to patient.  Grade 2 The most serious incidents reported by the Trust. Incidents would include alleged homicide by a patient accessing mental health services, the severe harm or death of a patient as a result of a Never Event. The Patient safety Team will grade the incidents in line with guidance from the Commissioners. Extensions to investigation timescales can be requested in exceptional circumstances and these requests should be made to the Patient Safety Team. 6.16 Investigations Incident investigations should be conducted at a level appropriate and proportional to the incident. The level of investigation should relate directly to the severity of an incident ensuring that sufficient time and energy is afforded to those incidents that are deemed significant. This section provides brief guidance on investigation requirements and must be read in conjunction with the Investigation Policy in relation to investigation of incidents. The actions taken following an incident to enquire what, how and why an incident has occurred. Investigations may be termed as local, when undertaken by staff or managers of the area involved or as RCA investigations where a more detailed level of investigation is required. Investigations are necessary to provide a retrospective review of events. The singular or aggregated analysis, whether at local or Trust-wide level can be used to identify areas for change, recommendations and sustainable solutions, to help minimise reoccurrence in the future (please refer to the Analysis, Improvement and Learning Policy). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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6.17 Management of Incidents Graded as SIs 24 Hour Report Forms (see Appendix 7) must be completed for SIs in addition to the completion of Trust Incident Report Forms. For the Trust’s most serious SIs such as inpatient suicides and alleged homicides, an update to the initial information will be required within 72hours in order to keep Directors and Commissioners updated. Those incidents graded as an SI must be reported immediately to the senior manager on duty/call who will notify the appropriate director. The SI procedure covered in Appendices 10 and 11 must be followed. The following section describes Head of Service/General Manager dependant on the incident location. For the purpose of ease of reading this policy, this section will refer to this discipline as the Service Senior Manager. On discovery of an SI, the staff member should inform the line manager who in turn will notify the Service Senior Manager immediately. The Service Senior Manager has responsibility to ensure that the incident has been contained as far as possible and further reporting of the incident takes place. An SI must be managed in the first instance by the Service Senior Manager, who will immediately notify the Service Director. If the incident is out of working hours, then the role of the Service Senior Manager is the responsibility of the on-call manager. The manager of the area and the Service Senior Manager will make contemporaneous records of actions following the incident and will make these available to the Director to inform the investigation. Out of hours responsibility for this is the on-call Manager. The Director will make this information available to the Patient Safety Manager to be held centrally in the SI file and to brief the Chief Executive. The Service Senior Manager will contact the responsible Director (or On-Call Director out of hours by on-call manager) immediately. The Service Senior Manager/on call manager will ensure that immediate action safety; support and communication actions have been undertaken by the area manager. The Service Senior Manager/on-call Manager will secure any paper clinical records in the event of a missing patient or unexpected death of a patient. These records must be hand delivered to the Patient Safety Team within 48 hours of the SI. These will be copied and retained for the purpose of investigation and the originals will be given to the Clinical Records Department for safe keeping. The area manager will during the current shift, arrange to obtain statements, dated and timed from those staff on duty. Distressed staff should be supported, debriefed and offered access to the critical incident support service and given the opportunity to produce a statement at a later date. In cases of an inpatient SI, the responsible Director will ensure that the Senior Service Manager/on-call Manager attends the incident area within two hours of the incident to The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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support staff. This will include where necessary, releasing distressed staff from duty and arranging necessary cover. The Service Senior Manager will ensure that the Clinical Director and Responsible Clinician for the patient involved (where applicable) are notified of any SI involving a patient. The Service Senior Manager will inform the Trust Mental Health Act Administrator of any unexpected death of a patient detained under the Mental Health Act 1983 and other agencies such as the Police, where necessary. A list of external reporting agencies is at Appendix 5. On call Directors for the Trust (1731 to 0829 hrs) will contact the on call Director at the Commissioners (contact details are listed in the Director on-call folder) for notification of the most serious categories of SI’s that fall into the following categories:   

Incidents which necessitate activation of the Trust’s Emergency Plan and where NHS East Midlands (the SHA) need to take action e.g. attendance of NHS East Midlands Director required at multi-agency gold command. Incidents that will give rise to significant media interest or will be of significant interest to other agencies such as the Police or other external agencies. Incidents that will be of significant public concern.

The Commissioning on-call Director has responsibility to consult and communicate with the on-call director of the SHA. In working hours this will be notified to the Commissioners by the Patient Safety Manager. The Patient Safety Manager reports this electronically on the Untoward Incident Module of STEIS within 1 working day of the SI www.performance.doh.gov.uk/steis. This information is accessed by the Commissioners and the SHA. The Director will ensure that the Patient Safety Manager is notified of the SI immediately during normal working hours so that the external reporting and facilitation of the investigation can commence. This also relates to out of hours SIs. During shift changes appropriate handovers should include any SI incident information to all staff. This is the responsibility of the manager of the team. Media communications must be directed to the Head of Communications and Chief Executive’s office to ensure patient confidentiality is maintained. The Head of Communications through liaison with the Chief Executive will manage all media communications. Staff must not communicate directly with the public/media. The Director will identify an incident investigator or investigating team and produce a terms of reference within 48 hours of notification of the incident. For the most serious SI’s the Chief Executive will appoint an investigation team and produce a terms of reference. Each terms of reference should demonstrate that is has been considered following consideration of the initial incident details (the Trust’s Investigation Policy should be referred to for further guidance on investigations). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Regular updates on progress with management and investigation of the incident should be obtained by the Director and shared with the Chief Executive and Patient Safety Manager. The Director will ensure that communication links are established with the patient/relatives/carer before and during the investigation process and afterwards to ensure involvement, feedback of investigation findings and continued support. The Director will appoint an appropriate member of staff to be the named communication link with the affected patient/relative/carer. This is normally listed as a requirement in the terms of reference. This person will have responsibility for maintaining communications with the patient/relative/carer throughout the reporting/investigation/outcome process in line with the Trust’s Being Open policy which should be referred to. If the incident is likely to cause multiple enquiries from patients and/or the public of a significant volume, the Director must follow the guidance in the Trust’s Emergency Plan to arrange initiation of a Hotline Service. The Senior Service Manager and any on call manager will work closely with the Investigating Manager/team to ensure all details relating to the incident are communicated. This includes feedback to all staff of the affected area of the investigation report and action plan when finalised with the Director and Chief Executive. 6.18 Reporting and Investigating the Most Serious Events in the Organisation and Independent Investigations The Trust is required to:  Inform NHS Midlands and East (SHA) within one working day when such an incident occurs.  Formally report the incident to Commissioners via the SI electronic notification process via STEIS.  Conduct an initial management review within 72 hours of being aware of the incident to identify any necessary urgent action.  Ensure that support is offered to families of victims and perpetrators and also to staff who have been involved in the care of the patient.  Conduct an internal investigation that meets the Trust’s standard for conducting SI investigations, using root cause analysis methodology, identifying any underlying causes and any further action required within 60 working days of the incident unless otherwise agreed with NHS Midlands and East.  The Trust must ensure that both victims and perpetrators families have the opportunity to met with senior, appropriately experienced staff from the Trust to allow them to contribute to the investigation and discuss findings should they wish to do so.

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   

Ensure other key stakeholders involved in the patient’s care pathway. Inform Commissioners of progress with criminal proceedings, for example court dates. Ensure the Trust Board of Directors receives the report and agrees the action plan in response to the recommendations. Performance manage the action plan and provide regular reports on progress to Commissioners and to the Trust Board of Directors.

6.19 Independent Investigations Commissioners will review the initial management review report and arrange a meeting with the Trust and any other stakeholders to discuss the internal investigation process and likelihood of an independent investigation. Following receipt of the Trust internal investigation report Commissioners will confirm whether the incident meets the criteria to commission an independent investigation and what the terms of reference and scope of the investigation will be. The scope and process for the independent investigation will take into consideration the quality and findings of the Trust’s internal investigation. Please refer to the flow chart at Appendix 3. A full copy of Commissioners Policy can be obtained from the Patient safety Team. 6.20 Investigations Details of investigation requirements are summarised in this policy and the Investigation Policy should be referred to for investigation incidents based on the grading of severity. 6.21 Learning from Incidents Details of analysis and learning requirements are summarised in this policy and the Analysis, Improvement and Learning Policy should be referred to in order to ensure that learning is identified from incidents and implemented. 6.22 Risk Management Report covering learning The Patient Safety Manager will produce bi-monthly reports that will summarise analysis of incident data and outcomes identified through audits. Learning will also be identified from external sources, such as the NPSA National Reporting and Learning System Feedback Reports and will make recommendations for learning or risk reduction measures. 6.23 Incident Reports to Specialty Leads/Groups/Organisations The Patient safety Team will provide:  Monthly medication incident reports to the Medicines Management Committee.  Incident reports on categories requested by and for submission to managers and/or the directorate operational groups for the consideration of risk management issues.

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6.24 Assurance Reports and Meetings The Patient Safety Manager will provide:  Bi-monthly SI reports to Trust Board of Directors covering performance management, compliance with Being Open, and learning themes and analysis of SI data for the current and previous years. The report will also cover progress on completion of actions plans from SIs.  Quarterly meeting with Nene CCG in order to provide assurance on the reporting and management of SIs. 6.25 Audit of Incident Reporting The Datix Manager will audit the quality of incident reporting and produce feedback reports to managers for implementation of learning on reporting, grading and investigation of incidents that are outside of the SI process. 6.26 Health and Safety Incidents If the incident appears to be RIDDOR reportable it must be notified to the Health and Safety Manager within 24 hours or on the next working day, in addition to completion of an incident report form. This is the responsibility of the person authorising the incident form. The Health and Safety Risk Manager will determine if this is reportable to the Health and Safety Executive and be responsible for this external reporting and supporting the manager in conducting an investigation. For further guidance, please access the following link: http://www.hse.gov.uk/riddor/ 7.

DUTY OF CANDOUR

7.1 Regulation 20 CQC Regulation 20 states that a Health Service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to services users in carrying on a regulated activity. As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, a health service body must notify the relevant person and provide reasonable support to the relevant person. This must be followed by written notification and apology for the incident. The Trust must keep a copy of all correspondence with the relevant person in a secure place. An account should be provided of all the facts the Trust knows about the incident as at the date of the notification and any further facts as they arise. The Trust should make every reasonable effort to contact the relevant person through various communication means, if the relevant person declines to contact the provider, their wishes should be respected and a record of this kept. There may be occasions where it may not be appropriate to contact the relevant persons, for example during a Police investigation of an incident – advice should then be sought from the Patient Safety Team. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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8.

TRAINING

8.1 Mandatory Training Training required to fulfil this policy will be provided in accordance with the Trust’s Training Needs Analysis. Management of training will be in accordance with the Trust’s Statutory and Mandatory Training Policy’. 8.2 Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual’s training needs as defined within their annual appraisal or job description. 9. MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts’ monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Aspect of compliance or effectiveness being monitored Duties How all incidents and near misses involving staff, patients and others are reported. Reporting of incident information to external agencies.

That staff are able to and where this is necessary, have raised concerns through routes such as whistle blowing, open disclosure etc. Staff have completed training associated with this policy in line with the TNA

Group or committee Method of Monitoring who receive monitoring frequency the findings or report To be addressed by the monitoring activities below. Audit of 10% of Datix Quarterly Governance incidents Manager and Committee reported. annually via reports.

Group or committee or individual responsible for completing any actions

10% sample of different types of incidents for assurance of reporting. Review with HR Directorate of matters reported to them linked to incidents.

Individual responsible for the monitoring

Governance Committee

As above

As above

As above

As above

As above

Annually

As above

As above

Training will be monitored in line with the Statutory and Mandatory Training Policy.

Where gaps in compliance are identified through monitoring, the responsible committee will identify required actions and a lead and will monitor further actions to ensure that full compliance is achieved through further assurance reports to the individual/committee. 10.

REFERENCES AND BIBLIOGRAPHY

Never Events Framework (January 2012 update) (NPSA). High Quality Care for All – NHS Next Stage Review Final Report (Department of Health, June 2008). The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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An Organisation with a Memory (Department of Health, 2000). Building a Safer NHS for Patients (Department of Health, 2001). Safety First (Department of Health, 2006). NPSA’s Being Open Framework (2009) and the Patient Safety Alert issued in November 2009 (NPSA/2009/PSA003). NHSLA Acute, Community, Mental Health & Learning Disability and Independent Sector Standards – 2011/12 Reporting of Injuries, Diseases and Dangerous Occurrence Regulations (Health and Safety Executive, 1996). Freedom of Information Act 2000. Seven Steps to Patient Safety – the full reference guide (NPSA, 2004). Doing Less Harm (Department of Health and NPSA, 2001). Health and Safety at Work Act 1974. Management of Health and Safety at Work Regulations (Health and Safety Commission, 1999). Memorandum of understanding: Investigating patient safety incidents involving unexpected death or serious untoward hard: A protocol for liaison and effective communications between the NHS, Association of Chief Police Officers and Health and Safety Executive (Department of Health, 2001). Department of Health Circulars HSG/94/27 and HSC/98/197. Mental Capacity Act 2005 Data Protection Act 1998 Freedom of Information Act 2000 Care Quality Commission Guidance for NHS bodies on the fit and proper person requirement for directors and the duty of candour consultation. July 2014.

11.

RELATED TRUST POLICY                     

CRM001 CRM003 CRM004 CRM005 CRM008 CRM006 HSC002 HR41 HR17

- Risk Management Strategy - Concerns and Complaints Policy - Claims Management and Legal Advice Policy - Analysis, Improvement and Learning Policy - Investigation Policy - Being Open Policy - Policy and Guidance for the Use of Risk Register - Stress - Policy and procedure for dealing with employee incapability – sickness absence PH10 - Trust Emergency Plan CLP047 - Policy for Safeguarding Children (Child Protection) CLP055 - Policy for Safeguarding Vulnerable Adults NHS Northamptonshire Policy for the Reporting and Handling of Serious Incidents (SI). MMG001 - Guidelines for Controls of Medicine Policy HR025 - Statutory and Mandatory Training Policy CLP047 - Policy for Safeguarding Children (Child Protection) CLP055 - Policy for Safeguarding Vulnerable Adults HR09 - Guidance for Staff Raising Issues of Concern HR13 - Corporate and Local Induction Policy HR13 - Corporate and Local Induction Information Governance Incidents Procedure

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APPENDIX 1 – NEVER EVENTS An overview of the main guidance relevant to the Trust is given below, and more detail and further links can be found at www.npsa.nhs.uk/nrls/neverevents A Never Event is an incident category listed below that has resulted in severe harm or death to the patient involved: No 1 2 3 4

Applicable Never Event Wrong site surgery Wrong implant/prosthesis Retained foreign object post-operation Wrongly prepared high-risk injectable medication

5

Maladministration of potassium containing solutions Wrong route administration of chemotherapy Wrong route administration of oral/enteral treatment

6 7

8 9

Intravenous administration of epidural medication Maladministration of insulin

10

Overdose of midazolam during conscious sedation Opioid overdose of an opioid-naïve patient

11 12

Palliative care hospice and in own homes Learning disabilities, mental health, community nursing, palliative care, health respite, rehabilitation wards Palliative care, community nursing Community nursing, learning disabilities, mental health, wards and hospices Dentistry NPS Community services, Palliative care, hospice. Hospice at home Mental health, NPS community services

13 14

Inappropriate administration of daily oral methotrexate Suicide using non-collapsible rails Escape of transferred prisoner

15 16

Falls from unrestricted windows Entrapment in bedrails

17

19

Transfusion of ABO-incompatible blood components Transplantation of ABO or HLA – incompatible organs Misplaced naso or oro-gastric tubes

20 21

Wrong gas administered Failure to respond to oxygen saturation

22 23 24 25

Air embolism Misidentification of patients Severe scalding of patients Maternal death due to post partum haemorrhage after elective caesarean section

18

Applicable Service Dentistry, Podiatry Sexual health, Outreach contraception Dentistry, sexual health Mental health, learning disabilities, dentistry, palliative care including hospices, community nursing services, Rehabilitation ward, podiatry Resuscitation procedures across NHfT

Mental health , rehabilitation beds, hospices Not applicable – no mental health medium or high secure services (does not apply to low secure). All inpatient settings ECT, rehabilitation wards, LD inpatient services, palliative care inpatient settings, NPS Community services (beds at home with bedrails) Day hospitals, hospices Not applicable Learning disabilities, respite settings, palliative care inpatients, community nursing ECT, NPS inpatient settings, dentistry Learning disabilities, ECT, community nursing, NPS inpatient settings, podiatric surgery, dentistry All patient settings All patient settings All patient settings Not applicable

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 2 – HEALTHCARE ASSOCIATED INFECTIONS SIs A HCAI Serious Incident (SI) is defined as:  All identified cases of MRSA bacteraemia  Clostridium difficile cases as follows:  Classified as 1a on the death certificate where it is clear Clostridium difficile has made a significant contribution to cause of death (The Consultant responsible for managing patient care at time of patients death is accountable/required to decide whether Clostridium difficile was a contributory factor of death)  Cases where a serious complication including colectomy arise due to Clostridium difficile  All Hospital and Community based outbreaks that:  Result in high mortality for staff, patients or the community  Involve highly virulent and transmissible organisms  Require control measures that have an impact on the care of other patients, including limitation of access to healthcare services or where business continuity will be affected  Are sufficiently serious to require the convening of an incident team and/or are transmissible with an impact on staff, patients or the community  Infected healthcare worker or patient incidents necessitating consideration of look back investigations (e.g. TB, VCJD, blood borne infections)  Significant breakdown of infection control procedures with an actual or potential for cross-infection (e.g. release of products from a failed sterilisation cycle, contaminated blood transfusion) Norovirus outbreaks Either of the following two triggers will result in the organisation reporting an SI: 1. One or more wards closed due to norovirus 2. An outbreak meeting has been called.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 3 – FLOW CHART FOR HOMICIDE SIs – INTERNAL INVESTIGATION PROCESS (for further details please refer to NHS Midlands and East policy) Very Serious Incident (SI) occurs

In hours (9:00 – 17:00) SIs Inform SHA Patient Safety Team on 0115 968 4439

Trust Comms works with SHA Comms to develop media handling strategy and develop a MBU alert

NHS Trust logs incident onto STEIS within 24 hours or next day for OOHrs Liaison with police and other key stakeholders regarding investigation process



For OOHrs (17:01 – 8:59) SIs that fulfill the following criteria, contact NHS EM Director on Call 08700 555 500  Activation of NHS Trust/PCT Major Incident Plan (multi-agency gold command)  High profile and likely to attract local/national media interest  Involvement of Police/ other agencies  Significant public concern

Commissioners made aware via STEIS

NHS Trust completes initial service. Management review within 72 hours and update STEIS

NHS Trust/SHA meet to discuss internal investigation

Inform relevant Commissioners of outcome

Internal investigation carried out by NHS Trust within 60 working days and STEIS updated

Internal investigation reviewed by SHA The Trust Serious Incident Group within one month

Criteria for independent investigation met?

No

Close incident when assurance received that robust action plan is in place, as per SI policy

Yes

Commission independent investigation

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 4 - REPORTING ROUTES FOR GRADE 2, 3 & GRADE 4 PRESSURE ULCERS

IDENTIFY Grade 2, 3 or 4 Pressure Ulcer (PS) Identified Use unique pt ID (NHS number or D.o.B + initials when recording)

INVESTIGATE Did the PU originate under the care of the identifier?

REPORT & RCA YES

1) NHS Care, including funded residential

•Report Grades 2,3,4 via LRMS •Report grade 3,4 and upgradeable to STEIS, as well as LRMS

•Conduct RCA within 45 working days or give reason for extension to Commissioners NO

2) Social Services Residential Care

•Report 3&4 & upgradeable to Local Report to Commissioners with as much detail as known regarding previous history / admissions / residence of patient Commissioners then report grade 3,4 and upgradeable on STEIS* under its commissioning ID

Authority and to CQC (Not STEIS)

Commissioners passes to next previously identified provider / residence. (If one cannot be identified request to review GP notes to help track back)

•Use internal systems to review grade 2 3) Private Care Provider

•Report to 3 & 4 to CQC (Not STEIS) •Use internal systems to review grade 2

NO YES Did the sore originate with this provider?

As the box above, though the PU should previously be recorded on STEIS by the Commissioners & only needs transferring to the provider of origin (inform the Commissioners to do so)

*The Commissioners will report the Grade 3 & 4 (upgradeable) pressure ulcers of unknown origin to STEIS as soon as they are notified. When the origin is identified the STEIS entry will be transferred to that provider if NHS or removed if the PU originated under a Social Services or Private Care Provider

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 5 – EXTERNAL STAKEHOLDERS Area of concern Serious Incident Most Serious Events Medical Devices Reporting of Diseases and Dangerous Occurrences Litigation

Responsible Body Relevant Commissioners Relevant Commissioners Medicines and Healthcare Products Regulatory Agency (MHRA) Health and Safety Executive

Reporting Responsibility Patient Safety Manager Patient Safety Manager Medical Devices Lead

NHS Litigation Authority

Deputy Director of Corporate Services Patient Safety Manager and responsible Director

Unexpected death of patient / Responses to Regulation 28 Recommendations Media interest

H M Coroner and H M Coroner’s Officers

Medication issues

Medicines and Healthcare Products Regulatory Agency (MHRA) Central Alert System (DoH) National Patient Safety Agency Police

Safety alerts Patient safety incidents Criminal matters

Fire related issues Safeguarding Estates and Facilities Copies of independent investigation reports by external agency. Incidents that meet the criteria for exception reporting to MONITOR Audit information on suicides and homicides Security incidents (fraud) Unexpected death of patients under a section of the The Trust Act 1983. General Medical Council Nursing and Midwifery Council Health Professions Council

The Media

Northamptonshire Fire and Rescue Nene CCG/ Northamptonshire County Council NHS Estates

Health and Safety Manager

Communications Lead and Chief Executive Pharmacy Lead Health and Safety Manager Datix Manager Director, senior staff and the Local Security Management Specialist Fire Officer Safeguarding Lead

Care Quality Commission

General Manager – Facilities/Fire Safety Advisor Director/Chief Executive

MONITOR

Director of Nursing and Quality

National Confidential Enquiry into Suicide and Homicide by People with Mental Illness NHS Counter Fraud Service (CEAC) The Trust Act Commission (now the Care Quality Commission)

Suicide Prevention Lead

Concerns in relation to medical staff practice/conduct Concerns in relation to nursing staff practice/conduct Concerns in relation to practice of allied healthcare professionals

The Medical Director

Trust Security Lead (LSMS) The Trust Mental Health Act Manager

Director of Nursing and Quality Director of Human Resources and Organisational Development / or Professional Lead

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 6 – INCIDENT REPORTING FLOWCHART INCIDENT OCCURS AND IS GRADED

INCIDENT GRADED AS SERIOUS

ALL OTHER INCIDENTS

INCIDENT REPORT FORM COMPLETED

COMPLETE 24HR REPORTSEND TO DIRECTOR HEAD OF RISK MANAGEMENT & PATIENT SAFETY

by person involved /other appropriate person

DECISION WHETHER TO DECLARE AS AN SI taken by Director and Patient Safety Manager

PASSED TO LINE MANAGER FOR ACTION Local investigation, identification of immediate remedial actions and incident form/DatixWeb updated

MANAGER TO PROVIDE FEEDBACK TO STAFF/PATIENT/OTHERS INVOLVED IN INCIDENT

INCIDENT INVESTIGATION PROCESS FACILITATED BY Patient safety Team

CORPORATE AND LOCAL REPORTING AND MONITORING OF INCIDENTS AND OUTCOMES OCCURS

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

APPENDIX 7 - 24 HOUR REPORT FORM Directorate

Incident location

Patient details – where relevant Patient name/ address Patient’s next of kin details and address:

Date of incident

Patient’s date of birth Consultant/Responsible Clinician:

Have they been notified? Yes/No Patient’s ethnicity:

Patient status (inpatient, on leave, community) CPA status (if applicable)

Has next of kin been notified? Yes/No Date/capacity last seen MHA or MCA Status (if applicable)

Diagnosis

Current location of patient

Incident summary

Relevant background information including brief history of contact with our services

Brief details of current care plan and risk assessment State care plan status e.g. enhanced etc. State if risk assessment is currently up to date and identified risks

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

Chronology of events leading up to the incident – detail last 24 hours of contact with the patient

Detail here any initial findings and actions (including improvements and learning details) implemented immediately

List details of all staff involved in the care of the patient and details of initial support given:

Details of communications with patient/family/carer etc:

Are there any safeguarding issues? Yes/No If yes, detail actions/notifications undertaken

External stakeholders and details of communications

Print name of person completing this report: ………………………………………………………………………… Signature …………………………………………………………… Date:…………………………………………. Time ………………………….. If you email this form, please phone the Patient Safety Team to ensure secure receipt. Remember to send this form to both your Director and the Patient Safety Team. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

APPENDIX 8 - IG Checklist Information required by the Department of Health for category 3+ SI Unique SI Reference: Initial assessment of level of SI (1-5): NHS East Midlands: Local Organisation(s) involved: Required Information Check 01 Date, time and location of the incident 02 Confirmation that DH guidelines for incident management are being followed and that disciplinary action will be invoked if appropriate 03 Description of what happened: Theft, accidental loss, inappropriate disclosure, procedural failure etc. 04 The number of patients/ staff (individual data subjects) data involved and/or the number of records 05 The type of record or data involved and sensitivity 06 The media (paper, electronic, tape) of the records 07 If electronic media, whether encrypted or not 08 Whether the SI is in the public domain and whether the media (press etc.) are involved or there is a potential for media interest 09 Whether the reputation of an individual, team, an organisation or the NHS as a whole is at risk and whether there are legal implications 10 Whether the Information Commissioner has been or will be notified and if not why not 11 Whether the data subjects have been or will be notified and if not why not 12 Whether the police have been involved 13 Immediate action taken, including whether any staff have been suspended pending the results of the investigation 14 Whether there are any consequent risks of the incident (e.g. patient safety, continuity of treatment etc.) and how these will be managed 15 What steps have been or will be taken to recover records/data (if applicable) 16 What lessons have been learned from the incident and how will recurrence be prevented 17 Whether, and to what degree, any member of staff has been disciplined – if not appropriate why? 18 Closure of SI – only when all aspects, including any disciplinary action taken against staff, are settled. Notes:

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

APPENDIX 9 – GUIDANCE ON PRODUCING STATEMENTS AND STATEMENT FORMAT If you are unsure about whether a statement is necessary, or what should be contained within that statement, please contact the Patient Safety Team before compiling your statement.   

Where possible statements should be typed and if more than one page is used all pages must be signed and dated Statements should ideally be written within 24 hours of a serious incident occurring but no later than 10 days Original statements should be dated, signed and time of statement given. This should then be forwarded to Patient safety Team

What your statement should contain  Facts only  Who you are – name, grade, ward/specialty  Where the incident occurred  Time of the incident  Your involvement in the incident  What happened  What you knew about the patient or member of staff at the time of the incident  What you found on examination/on seeing the patient or member of staff  The situation with which you perceived you were dealing  What you did/did not do  Why/why not? What your statement should not contain  Opinion  Petulant comment  A verbatim regurgitation of the entries made in the clinical records – statements are designed to ‘flesh out’ information contained therein PLEASE NOTE Statements made following an adverse incident – if litigation has not been intimated at the time the statement is written – the statement will be disclosable if the case subsequently becomes the subject of a claim, i.e. the affected person’s legal team will have access to the statement. For that reason, it is important that if any member of staff is unsure whether to write a statement, or the format of that statement, they should contact the Patient Safety Manager for advice. Please also note that emails written between staff members, before legal action has been intimated, would be disclosable to the affected person’s legal team should the case become the subject of a claim. Staff are entitled and supported to seek advice from their respective professional organization/union/manager when producing a statement. The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

Statement of: (insert name of staff member) Relating to: (insert name of patient)

D.O.B of patient:

Date of Incident:

Time of Incident:

Occupation of (insert name of staff member and job title): employed by Northamptonshire Healthcare NHS Foundation Trust at (insert name and address of site and description of service i.e. acute the Trust directorate)

Give your background covering your qualifications in relation to your role and how long you have been in your current post. Give the background knowledge that you have of the person this statement relates to and then detail your involvement in the incident. Do not use abbreviations.

Signature Print Name:

Date Time of statement

Page

of

This statement is disclosable under the Data Protection Act 1998 and Freedom of Information Act 2000

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 10 – SI REPORTING IN OFFICE HOURS Within Office Hours Covering First 24 Hours

SI Occurs

BEFORE GOING OFF DUTY Complete Incident Form

IMMEDIATELY Staff member to inform one of the following:

Modern Matron Head of Service LD Managers Director

Co-ordinate support and cover for any staff to be released from duty

To Notify

WITHIN 30 MINUTES OF SI 

Communicate with: Patient/Relatives/ Carers

Followed by:

 



Immediately Responsible Director Patient Safety Manager

Where necessary contact person in Trust with reporting responsibility to: Police The Trust Mental Health Act Manager Refer all communications from the public/media to Chief Executive/ Communications Lead

Patient Safety Manager

Head of Service/Modern Matron/LD Managers:

WITHIN 24 HOURS OF SI Complete an Initial Management Review Report and submit to Director and Patient safety Team Ensure de-brief arrangements

Director Secure Paper Clinical Records WITHIN 24 HOURS Obtain statements Hand-deliver paper clinical records in event of patient death or copy clinical records for any other category of SI to Patient Safety Team

WITHIN 1 DAY OF NOTIFICATION

Within 48 Hours produce Terms of Reference for investigation

Relevant external reporting to take place: e.g.:  NHS East Midlands/ NHS Northamptonshire Where necessary:  Health and Safety Executive  National Patient Safety Agency  Social Services

Appoint Investigating Manager/Team

COMMUNICATIONS TO THE PUBLIC/MEDIA MUST BE REFERRED TO THE CHIEF EXECUTIVE/COMMUNICATIONS LEAD

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 11 – SI REPORTING OUT OF OFFICE HOURS Outside Office Hours Covering First 24 Hours

SI Occurs

Before going off duty complete Incident Report Form and send to Patient Safety Team

IMMEDIATELY Staff member to contact On-Call Manager WITHIN 30 MINUTES OF NOTIFICATION On-Call Manager to contact On-Call Director

IMMEDIATELY On-Call Director to advise On-Call Manager on communicating with Patient/Relatives/Carer and Outside Agencies i.e. Police

ON-CALL MANAGER WITHIN 2 HOURS OF NOTIFICATION Ensure urgent attendance at scene to support staff and if necessary to co-ordinate cover for staff who need to be released from duty. Arrange for statements from staff to be co-ordinated. N.B. Secure Paper Clinical Records if patient death incident or copy records for any other SI.

ON CALL DIRECTOR TO REPORT SI TO ON CALL PCT DIRECTOR OR SHA DIRECTOR

Hand deliver to Patient ON CALL DIRECTOR TO Safety Team in working

NOTIFY RISK MANAGEMENT DEPARTMENT

Patient Safety Manager to verify that external reporting requirements are fulfilled.

BY NEXT WORKING DAY hours during next day COMMUNICATIONS TO THE PUBLIC/MEDIA MUST BE REFERRED TO THE CHIEF EXECUTIVE/COMMUNICATIONS LEAD The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

APPENDIX 12 – RISK SEVERITY TEMPLATE Q1. Identify the highest consequence of this risk, taking account of the controls in place and their adequacy, how severe would the consequence by of such an incident? Apply a score according to the following scale: 1 Insignificant

Descriptor

Patient harm / outcome / experience

 No obvious harm.  Patient dissatisfaction.

Staff / Visitor etc. Injury / Psychological / Social

 No injury/illness not requiring first aid.

Health Inequalities (Equity of access to care and/or inequity in wider public health)

 Possible/minor loss of potential for reducing health inequalities,

2 Minor  Minimal harm.  Experience readily resolvable.  1-2 people affected  Minor Injury/Illness requiring first aid/minimal treatment or care.  Short-term staff sickness (< 3 days)  1-2 people affected.  Unable to investigate, develop/pilot future improvements in services/activities that are likely to reduce health inequalities.

3 Moderate    

Some harm. Mismanagement of patient care. Short-term effects 3 days) - RIDDOR 3-15 people affected Unable to implement intended developments in services/activities that have significant potential to reduce health inequalities. Justified complaint involving lack of appropriate care. Litigation/enforcement action possible. Below excess.



Moderate loss/interruption (> 1 day)



Late delivery of key objectives/service due to staffing levels. On-going unsafe staffing level, skill level ineffective. Loss > 0.25 of budget. £500,000 loss of contractual income. Local media – long term relations with public affected. Moderate loss of confidence in the Trust and significant effect on staff morale.

  

 Complaint/Litigation

 Locally resolved complaint.

 Justified complaint peripheral to patient care.  Litigation unlikely.

Business/Service Loss

 Minimal impact.  No service disruption.

 Minor loss/interruption (> 8 hours)

Staffing & Skill Level

 Short-term low staffing level that temporarily reduces service quality.

 On-going low staffing level reduces service quality.

Financial

 Small loss

 Loss > 0.1% of budget.

Reputation/Publicity

 No adverse publicity or loss of confidence in the Trust.

 Local Media – short term low impact on confidence and effect on staff morale.

Governance (Inspection/Audit & Policy Compliance)

 Minor non-compliance with standards.  Minor recommendations.

 Non-compliance with standards.  Recommendations given.

Objectives & Projects

Estates & Environmental

 Insignificant cost increase/schedule slippage.  Barely noticeable reduction in scope or quality.  Inconsequential damage to buildings/environment/historic resources that requires little or no remedial action.

 < 5% over budget/schedule.  Minor reduction in quality/scope.  Recoverable damage to ‘non-priority’ buildings/environment/historic resources.

4 Major



    

  

Reduced rating. Challenging recommendations. Non-compliance with core standards, legislation.



5-10% over budget/schedule slippage. Reduction in scope or quality.

 

Recoverable damage to ‘priority’ buildings, or loss of ‘non-priority’ buildings/environment/historic resources.

       

Permanent harm. Serious mismanagement of care. Misdiagnosis/poor prognosis. 16-50 people affected. Increased level of care (> 15 days) Major injury/illness requiring long-term treatment/incapacity/disability. Long-term sickness > 15 people affected.

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  

Death/life threatening. Totally unsatisfactory outcome/experience. > 50 people affected (e.g. screening concerns, vaccination errors).

  

Death. Life threatening injury/illness. Permanent injury/damage/harm.



Probability of increase in health inequalities OR permanent loss of existing service/activity targeted to reduce health inequalities.



Reduced effectiveness of existing service/activity that is targeted at reducing health inequalities.

  

Multiple justified complaints. Claim above excess level. Litigation/enforcement action expected.

  

Multiple claims or single major claim. Unlimited damaged. Litigation/prosecution certain.

  

  

 

Significant loss/interruption (> 1 week) Temporary service closure. Uncertain delivery of key objective/service due to staffing levels. Unsafe staffing levels, skill levels inadequate. Loss > 0.5% of budget. £1M loss of contractual income.

 

Permanent loss of service/facility. Impact in further areas. Non-delivery of key objective/service due to lack of staff. Serious incident due to insufficient training. Loss > 1% of budget. £2M loss of contractual income.

  

Widespread adverse publicity. National Media (< 3 days) Major loss of confidence in the Trust.

   

National Media (> 3 days) MP concern – questions in the House. Major loss of confidence in the Trust. Viability of the Trust threatened.

    

Low rating. Enforcement action. HSE intervention. Critical report. Major non-compliance with core standards, legislation.

    

Zero rating. Prosecution. Severely critical report. Loss of contracts. Public enquiry.

 

10-25% over budget/schedule slippage. Failure to meet secondary objectives.

 

25% over budget/schedule slippage. Doesn’t meet primary objectives.



Loss of or permanent damage to ‘priority’ buildings/environment/historic resources. Affecting part of the site.



Loss of or permanent damage to ‘priority’ buildings/environment/historic resources. Affecting the whole site.





The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

5 Catastrophic

Implementation Date: 30.04.2012





Q2. How likely is it that such an incident could occur? Score according to the following scale: Level Likelihood Description 1 Rare The event may only occur in exceptional circumstances 2 Unlikely The event is not expected to happen 3 Possible The event may occur occasionally 4 Likely The event is likely to occur 5 Almost certain A persistent issue Q3. Use the Matrix below to Grade the Risk. (i.e. 2 x 4 = 8 = Orange or 5 x 5 = 25 = Red) Risk scoring = consequence x likelihood ( C x L ) Likelihood Consequence 1 2 3 4 5 Almost Rare Unlikely Possible Likely certain 5 Catastrophic 5 10 15 20 25 4 Major 4 8 12 16 20 3 Moderate 3 6 9 12 15 2 Minor 2 4 6 8 10 1 Negligible 1 2 3 4 5 For grading risk, the scores obtained from the risk matrix are assigned grades as follows 1-3 Low risk 4-6 Moderate risk 8 - 12 High risk 15 - 25 Extreme risk Instructions for use Define the risk(s) explicitly in terms of the adverse consequence(s) that might arise from the risk. Use question 1 to determine the consequence score(s) (C) for the potential adverse outcome(s) relevant to the risk being evaluated. Use question 2 to determine the likelihood score(s) (L) for those adverse outcomes. If possible, score the likelihood by assigning a predicted frequency of occurrence of the adverse outcome. If this is not possible, assign a probability to the adverse outcome occurring within a given time frame, such as the lifetime of a project or a patient care episode. If it is not possible to determine a numerical probability then use the probability descriptions to determine the most appropriate score. Calculate the risk score, as per question 3, by multiplying the consequence by the likelihood: C (consequence) x L (likelihood) = R (risk score) Identify the level at which the risk will be managed in the organisation, assign priorities for remedial action, and determine whether risks are to be accepted on the basis of the colour bandings and risk ratings, and the organisation’s risk management system. Include the risk in the organisation risk register at the appropriate level.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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APPENDIX 13 – NHFT EQUALITY ANALYSIS TOOL

EQUALITY ANALYSIS REPORT NAME OF FUNCTION:

INCIDENT POLICY

DATE:

NOV. 14

ASSESSING OFFICERS:

KATE WOODFIELD, PATIENT SAFETY MANAGER

DESCRIPTION OF POLICY INCLUDING THE AIMS AND OBJECTIVES OF PROPOSED: (SERVICE REVIEW/REDESIGN, STRATEGY, PROCEDURE, PROJECT, PROGRAMME, BUDGET, OR WORK BEING UNDERTAKEN): TO ENSURE THAT THERE IS A SYSTEMATIC APPROACH TO THE ANALYSIS OF INCIDENTS, COMPLAINTS, AND CLAIMS AND THAT LESSONS ARE LEARNT AND SHARED WIDELY. EVIDENCE AND IMPACT – PROVIDE DETAILS DATA COMMUNITY, SERVICE DATA, WORKFORCE INFORMATION AND DATA RELATING SPECIFIC PROTECTED GROUPS. INCLUDE DETAILS CONSULTATION AND ENGAGEMENT WITH PROTECTED GROUPS. EVIDENCE BASE: BI-MONTHLY LEARNING ASSURANCE REPORT. SI REVIEW COMMITTEE AND LEARNING LESSONS FORUM TO CONSIDER CASE STUDIES. QUARTERLY AND ANNUAL COMPLAINTS REPORT. QUARTERLY COMPLAINTS REVIEW COMMITTEE.

SERVICE INFORMATION: PROVIDE ANY RELEVANT SERVICE DATA OR INFORMATION TO INFORM THE EQUALITY ANALYSIS INCLUDING SERVICE USER FEEDBACK, EXTERNAL CONSULTATION AND ENGAGEMENTS OR RESEARCH.

PROTECTED GROUPS (EQUALITY ACT 2010)

STAGE 3: CONSIDER THE EFFECT OF OUR ACTIONS ON PEOPLE IN TERMS OF THEIR PROTECTED STATUS?

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

EQUALITY ANALYSIS REPORT NAME OF FUNCTION:

INCIDENT POLICY

DATE:

NOV. 14 THE LAW REQUIRES US TO TAKE ACTIVE STEPS TO CONSIDER THE NEED TO: 

ELIMINATE UNLAWFUL DISCRIMINATION, HARASSMENT AND VICTIMISATION.



ADVANCE EQUALITY OF OPPORTUNITY



FOSTER GOOD RELATIONS WITH PEOPLE WITH AND WITH PROTECTED CHARACTERISTIC

IDENTIFY THE SPECIFIC ADVERSE IMPACTS THAT MAY OCCUR DUE TO THIS POLICY, PROJECT OR STRATEGY ON DIFFERENT GROUPS OF PEOPLE. PROVIDE AN EXPLANATION FOR YOUR GIVEN RESPONSE. AGE

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS. SAFEGUARDING INCIDENTS ARE SHARED WITH THE SAFEGUARDING TEAM. THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

EQUALITY ANALYSIS REPORT NAME OF FUNCTION:

INCIDENT POLICY

DATE:

NOV. 14

DISABILITY

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS WITH A DISABILITY ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS (E.G. INDIVIDUALS WHO ARE DEAF CAN BE SUPPORTED BY A BSL SIGNER). THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS.

GENDER (MALE, FEMALE AND TRANSSEXUAL, INCL.

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS.

PREGNANCY AND MATERNITY)

GENDER REASSIGNMENT

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS. THE

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

EQUALITY ANALYSIS REPORT NAME OF FUNCTION: DATE:

INCIDENT POLICY NOV. 14 TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS. TRANSGENDER IS NOT INCLUDED ON THE COMPLAINTS EQUALITY MONITORING FORM.

SEXUAL ORIENTATION (INCL. EQUALITY ISSUES ARE RECORDED ON MARRIAGE & CIVIL DATIX AND INCIDENT REPORTS ARE PARTNERSHIPS SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS. THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS. RACE

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS (E.G. INDIVIDUALS WHOSE FIRST LANGUAGE IS NOT ENGLISH CAN BE SUPPORTED BY AN INTERPRETER). THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

EQUALITY ANALYSIS REPORT NAME OF FUNCTION:

INCIDENT POLICY

DATE:

NOV. 14 AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS.

RELIGION OR BELIEF (INCLUDING NON BELIEF)

EQUALITY ISSUES ARE RECORDED ON DATIX AND INCIDENT REPORTS ARE SENT TO SERVICE LEADS/AREAS. INCIDENT REPORTS ARE SHARED WITH DIRECTORATES AND DISCUSSED AT DIRECTORATE MEETINGS. REASONABLE ADJUSTMENTS FOR INDIVIDUALS ARE MADE SO THAT INDIVIDUALS CAN PARTICIPATE IN THE PROCESS. THE TRUST WILL ENSURE THAT ITS COMMUNICATION IS UNDERSTANDABLE AND ACCESSIBLE AND IN A RANGE OF FORMATS TO MEET INDIVIDUAL NEEDS. RELIGION/BELIEF IS NOT INCLUDED IN THE COMPLAINTS PROCEDURE QUESTIONNAIRE.

EQUALITY ANALYSIS OUTCOME: HAVING CONSIDERED THE POTENTIAL OR ACTUAL EFFECT OF YOUR PROJECT, POLICY ETC, WHAT CHANGES WILL TAKE PLACE?

ACTION PLAN ISSUE TO BE ADDRESSED

ACTION WHO DATE TO BE COMPLETED

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

EQUALITY ANALYSIS REPORT NAME OF FUNCTION:

INCIDENT POLICY

DATE:

NOV. 14

RATIFICATION – A COMPLETED COPY OF THE EQUALITY ANALYSIS FORM MUST BE SENT TO EQUALITY AND INCLUSION OFFICER TO BE APPROVED. APPROVING OFFICERS

JULIE SHEPHERD, INTERIM DIRECTOR OF NURSING AND QUALITY

DATE OF COMPLETION:

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

APPENDIX 14 – Duty of Candour Checklist DUTY OF CANDOUR CHECKLIST ……………………………………………………..

Patient Name: Steis No.

……………………………………………………..

Date of Incident:

……………………………………………………..

Investigating Manager: …………………………………………………….. ………………………

Signature: Check box

Date(s)

Date: ………………

Contractual Requirement

1

☐

The patient or their family/carer was informed that a suspected or actual patient safety incident had occurred within 10 workings days of the incident being reported to local systems

2

☐

The initial notification was verbal accompanied by an offer of written notification with the notification recorded for audit purposes

3

☐

Patients or their carers/families have been given all the facts known at the time, and are or have been kept up to date throughout the process of the investigation

4

☐

An apology has been provided – verbally and in writing

5

☐

A step by step explanation of what happened, in plain English, based on the facts, was offered as soon as was practicable

6

☐

Full written documentation of any meetings have been and will be maintained including where these have been declined

7

☐

Incident investigation reports will be shared within 10 working days of being signed off as complete and the incident closed (with both Patient/Family and NHFT Teams involved)

8

☐

Documentation and information will be available to demonstrate compliance with these contractual requirements.

Once checklist has been completed please ensure it is returned to the Patient Safety Team ([email protected]) with the following:  

Copies of all written correspondence / minutes / meeting or telephone notes. Evidence of feedback and sharing of the anonymised report with the relevant teams. Evidence of feedback and sharing of the anonymised report with the patient / family / carers.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 4.11.14

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version Incident Policy (covering near miss and serious incidents)

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Implementation Date: 30.04.2012