Incident management policy

Contents

1 Introduction

Responding appropriately to incidents or circumstances that have caused or may cause harm to patients, staff, including contracted staff, or visitors is a key part of the way that the trust will continually improve the safety of the services that it provides.

An incident reporting, management and investigation process is essential to ensuring that the trust responds to and learns from incidents, and this policy lays out the process which facilitates the recognition, management and investigation of incidents and enables learning and the minimisation of future harm or loss within the trust.

When an incident has caused moderate (or more severe) harm or loss to patients and, or staff, the trust will respond to and investigate these following the National Serious Incident Framework (NHS England March 2015).

This policy includes the principles of ‘being open’ and the ‘duty of candour’ (see the trust’s being open and duty of candour policy and procedure) which ensures that effective communication with patient and, or their carers is central to our incident management and investigation. It also recognises the importance of the trust supporting learning rather than blaming culture to promote patient safety.

2 Purpose

The purpose of this policy is to outline the procedure by which all incidents and serious Incidents (SIs) within the trust will be reported, and managed. In outlining this procedure the policy sets out the trust’s systems, processes, and expectations in relation to incident reporting and learning to include the:

• process for reporting all incidents involving staff, patients, and others
• process for ensuring communication is open, honest, occurs as soon possible and is well documented.
• process for reporting to external agencies
• process for investigating incidents according to level of risk
• support available to staff who are involved in or witness to a serious incident
• interface with the trust learning from deaths policy the right thing to do, medical devices group and pressure ulcer review panel.
• process for involving and communicating with internal and external stakeholders to share lessons
• process by which the organisation ensures local and organisational learning and changes in practice resulting from individual incidents and aggregated analysis
• process for the aggregated analysis of incidents, complaints, and claims
• governance in place and process for providing assurance to the board of directors that appropriate actions are being taken, that lessons are being learnt, shared and improvements made to both care and service delivery following the occurrence of an incident.
• training requirements for staff

An overview of the pathway of how different incidents, including serious incidents are managed is provided in the flowchart in appendix A.

3 Scope

The policy applies to all staff employed within the trust (permanent, temporary, or honorary), students, volunteers, contractors, and employees of other organisations working on the trust’s estate.

4 Responsibilities, accountabilities and duties

4.1 The chief executive and board of directors

The chief executive, delegates through the board of directors the overall responsibility for the provision of adequate systems for the management of health and safety, including the reporting and managing of incidents, accidents and near miss events.

4.2 Director of nursing and allied health professionals

The director of nursing and allied health professionals is the designated board of directors’ lead for incident reporting via the Ulysses risk management system and the implementation of Being open and the duty of candour where appropriate.

4.3 Deputy director of safety and quality

The deputy director of safety and quality is responsible for ensuring that there is a framework for SIs to be effectively managed, investigated and that organisational learning is taking place. In addition the deputy director of safety and quality is responsible for the formal sign off of all SI investigation reports prior to submission to the relevant clinical commissioning group (CCG).

4.4 Serious incident group (SIG)

The SIG is responsible for:

• reviewing all incidents that have been graded serious as advised by the head of patient safety or patient safety specialist or their delegated representative and as defined in the trust incident management policy
• ensuring terms of reference and the quality of serious incident reports are robust
• evaluating those incidents that are serious incidents (SIRIs) according to the incident management policy and ensuring that they are reported in line with that policy.
• reviewing aggregated data reports pertaining to serious incidents reported to explore trends, and where required, initiate further review and investigation.
• reviewing any incident outside of the above definitions that has been deemed serious
• ensuring that databases or information sources that record and store data pertaining to serious incidents or SIRIs are maintained
• ensuring that appropriate investigations are undertaken, in line with trust policy
• ensure that appropriate actions are developed by Investigating Officers in conjunction with operational leads following investigations that adhere to SMART principles (NatPact, 2004)
• receiving and approving investigation reports and action plan updates, monitoring the implementation of any agreed actions identified by the services; progress against such actions will be monitored by the governance groups of each service, which will report to the SIG on a regular basis (for example, at least quarterly)
• if an investigation report requires urgent approval this will be circulated virtually by the head of patient safety by email to the members of the committee who will be expected to provide comments as soon as possible, the report will be included on the next SIG agenda for noting.
• ensuring that any corporate risks identified through the process are added to the trust risk register where appropriate
• ensuring that the services are disseminating lessons learned to staff via various routes, for example, alerts, training and education sessions, feedback via newsletters
• liaising with or reporting to all external stakeholders as appropriate
• where SIG identifies any professional or performance issues arising out of a SIRI investigation SIG will ensure that these are raised with the relevant operational manager for action

4.5 Head of patient safety or patient safety specialist

The head of patient safety or patient safety specialist is responsible for the operational management of the incident and SI process including:

• ensuring all incidents and SIs are managed and investigated both appropriately and within required time frames
• ensuring robust and timely action plans are produced
• line management of the trust’s Central Investigation team
• monitoring incident and SI themes across the trust and the implementation of action plans and reporting to the board of directors and Executive Management team
• supporting attendance of the relevant lead investigator at the CCGs’ SI committees, and responding to commissioning requests
• supporting the trust in its dissemination of learning from serious incidents across the care groups, and where relevant nonclinical services

4.6 Care group directors

The care group directors are responsible for ensuring that:

• all staff within their sphere of responsibility are aware of the need to complete the electronic incident reporting form (IR1), and if required the F2508 RIDDOR report forms
• for incidents rated as moderate harm or above, as appropriate in line with this policy one of the following is undertaken:
  • mortality review
  • structured review
  • referral to pressure ulcer panel
• the being open policy (incorporating the duty of candour) is implemented
• a member of staff is allocated to coordinate and lead a structured review of incidents which meet the required criteria
• any structured reviews undertaken in the care group are reviewed by the care groups or Senior Management team. On completion of this review the care group director will sign the structured review off on behalf of the triumvirate or Senior Management team
• all incidents requiring a detailed investigation are reported to the Patient Safety Investigation team
• a quality check of the SI report is completed within the care group before it is provided to the trust internal SI review panel
• sign off the SI report on behalf of the care group
• as required the relevant staff receive a debrief immediately following a serious incident having occurred and putting in place any additional ongoing support a staff member may require.
• action plans arising from the investigation are:
  • specific
  • measurable
  • achievable
  • realistic
  • timely
• action plans are fully implemented and completed within the agreed time frames
• if absent from work, they delegate their responsibilities under this policy to their nominated deputy

4.7 Ward or service or department managers

Ward or service and department managers are responsible for:

• ensuring that staff within their wards or services or departments are able to recognise an incident and know how to report it (on Ulysses IR1 System)
• ensure that the staff they manage are aware of the following:
  • the escalation process to senior managers both in and outside of normal working hours
  • if they are the designated person in charge at the time of the incident, they are responsible for ensuring the immediate safety and wellbeing of those involved in an incident
  • the need to ensure that any equipment implicated in an incident is retained, (including any associated non-disposables), for the investigation
  • where possible and if appropriate, photos are taken of the incident scene
  • where relevant, in the case of a serious incident, a record is made as to the location of staff at the time of the incident
  • staff on duty at the time of the incident are asked to make a written record of the events of their working day
• ensuring that, when required, witness statements are taken, and staff are supported to do this and to attend investigation interviews if requested
• reviewing (and finally closing, where possible within the required time frame) all reported incidents for their service, verifying that an appropriate level of investigation has taken place and been recorded and that the incident details, categorisation, and severity are recorded correctly
• ensuring that senior managers are informed of any incidents that may meet the criteria of a Serious Incident within 24 hours of the incident occurring
• leading on a service structured review, as requested by the care group director, or their nominated deputy
• liaising with the health and safety lead regarding any member of staff who is unable to perform their normal job for more than seven days as a result of an accident or incident at work and about any other potential RIDDOR reportable incident
• liaising with other relevant staff as necessary, such as subject matter experts, child and adult safeguarding leads and so on
• ensure that safeguarding adult procedures are followed where the incident involves any allegation or suspicion of abuse of an adult in the trust’s care
• ensure that staff are referred to the occupational health (OH) department following the reporting of any OH related incidents learning from experience by ensuring that:
  • incidents in area of responsibility are investigated according to the severity of the incident (see section 5.4), to identify what happened and why
  • incident information relating to their service is regularly reviewed and analysed to identify any patterns or trends that need to be investigated
  • necessary actions and changes are implemented based on the findings of incident investigations and reviews
  • feedback from the review of an incident is provided to those staff involved

4.8 Patient Safety Investigation team

The trust Patient Safety Investigation team is responsible for supporting the head of patient safety or patient safety specialist in the day-to-day operation of SI management including:

• ensuring the chief executive and directors are aware of any serious incident
• liaising with commissioners
• logging SIs onto the strategic executive information system (STEIS)
• facilitating the corporate review of the structured reviews undertaken in the care groups and providing feedback to the relevant care group director
• allocating the investigation of incidents that require a more in-depth level than is provided by a structured review
• ensuring that a 72-hour report is provided, and that the investigation report is submitted within the 12-week (60 working day) timescale to the relevant commissioning group
• production of reports to relevant groups including an annual report on patient safety to the trust
• completing the root causes and lessons learned boxes on the STEIS system following investigation
• supporting care groups with advice on the SI and RCA process
• report never events, assisting the national reporting and learning system (NRLS) to identify these incidents by adding the text never event within the incident description free text field on Ulysses or e-form prior to submission.

The team will also:

• be responsible for the day-to-day operation of the incident reporting system
• submit the relevant patient safety incident information through the e-form to the national patient safety agency (NPSA)
• make readily available to individuals who have rightful access, copies of completed incident report forms
• collate and analyse incident data regularly, producing summarised reports identifying trends and demonstrating a trust-wide overview of all reported incidents for the health and safety forum
• provide care group specific reports to facilitate detailed consideration of any required policy and practice changes to support organisational learning
• provide the trust with relevant patient safety incident data in respect to the care and treatment of service users

The trust Patient Safety team includes dedicated lead investigators, and it is these staff who undertake the investigation of incidents where the structured review has identified that further investigation is required.

Lead investigators are responsible for undertaking a full investigation as set out in this policy and using the tools and techniques outlined in the RCA training provided. They are also responsible for:

• working with professional leads (or an appropriate Senior professional) as relevant to the staff involved in the incident for example:
  • professional lead occupational therapist
  • clinical specialist speech and language therapist
  • lead clinical psychologist
  • accountable officer for controlled drugs (chief pharmacist)
  • head of information governance
• complying with the being open policy (incorporating the duty of candour) in communicating with the patient or relevant person as dictated within the being open policy (incorporating the duty of candour), this will include working with the designated incident Manager to ensure that the incident has been effectively managed and that the duty of candour requirements are complied with and closing duty of candour once their investigation has concluded
• seeking the views of any relatives or carers as part of their investigation
• providing feedback to relatives or cares in relation to their investigation findings
• attendance at the local CCG SI panel meetings to present investigation reports and answer any queries that may arise
• using the approved trust reporting template (see SI forms and templates on the intranet)
• timely submission of the investigation report to the care group director
• debriefing staff teams on the outcome(s) of their investigation focussing on identified good practice and areas for improvement
• benchmarking findings against trust policies and procedures, national guidelines and standards and current evidence base to determine good practices and areas for improvement, feedback will be provided to the care groups via the monthly dashboards

4.9 Designated incident manager

Unless otherwise delegated, the line manager or service manager of the person reporting the incident will be the designated incident manager (DIM).

The DIM will:

• ensure that all incidents regardless of type, damage or injury are accurately reported, using the electronic incident form (IR1) via the trust’s Ulysses electronic incident reporting system, as soon as is reasonably practicable, but within 24 hours of the incident (or becoming aware of the incident)
• report all potentially serious incidents to their manager or duty manager within 12 hours of the incident occurring (or becoming aware of the incident)
• log on to the system on receipt of a web incident notification being automatically emailed to them and complete and submit the manager’s form
• comply with the being open for all patient safety incidents, and the duty of candour for all incidents which are classified as a notifiable safety incident and have a level of harm of moderate or higher
• complete an investigation into the cause of the incident and put in place mitigating actions to manage the incident and prevent its reoccurrence
• for serious incidents, work with the lead investigators to ensure that the duty of candour requirements are complied with, and their investigation progresses effectively

4.10 Health and safety lead

The Reporting of Injuries, Diseases and Dangerous Occurrence Regulations (RIDDOR) 2013 requires a named responsible person on behalf of the trust to report to the local office of the health and safety executive (HSE).

The health and safety lead has been designated as the responsible person on behalf of the trust.

The health and safety lead will:

• be responsible for ensuring the statutory notification of those specified incidents to the health and safely executive (HSE)
• receive and manage the process of RIDDOR reportable incidents, checking that the forms are completed correctly and sent to the relevant office of the HSE in the prescribed timescale, normally 15 working days

4.11 Accountable officer for controlled drugs

The accountable officer for controlled drugs is responsible for:

• recording, assessing, and investigating concerns expressed about incidents that may have involved improper management or use of such drugs
• ensuring that appropriate action is taken for the purpose of protecting service users or members of the public in cases where such concerns appear to be well-founded

In this trust the role of the accountable officer is undertaken by the chief pharmacist.

4.12 Safeguarding team

It is the responsibility of the nurse consultant for safeguarding children and adults to have oversight of any safeguarding themes emerging from SIs, and that where a statutory safeguarding notification or response is required; this is actioned in a timely manner.

The nurse consultant for safeguarding children and adults will also act as the link between the trust SI investigation process and any statutory or learning lessons review processes undertaken by the relevant local safeguarding children or adult boards (LSCB or SAB).

In relation to any SI investigations which are also subject to safeguarding investigation processes the lead investigator and Safeguarding team will work together to reduce duplication and minimise the number of interviews staff may be required to attend.

4.13 Local counter fraud specialist

The local counter fraud specialist will report to NHS Counter Fraud Authority incidents of fraud and corruption. They will also undertake investigations into fraud, bribery and corruption’.

4.14 Local security management specialist (LSMS)

The LSMS will assist in, or lead on investigations into crime, violence and aggression and other security-related issues as required. They will also keep the security management director and board up to date with any serious incidents that may impact on the trust’s reputation.

4.15 Mental Health Act manager

The Mental Health Act manager is responsible for reporting to the Care Quality Commission (CQC):

• the death of a detained patient
• the outcome of any application made to a supervisory body in relation to depriving a service user of their liberty. See MCA Mental Capacity Act 2005 policy
• the admission of a child or young person (under the age of 18) to an adult psychiatric ward or unit
• any absence without leave (AWOL) of a person who is detained or liable to be detained under the Mental Health Act 1983 in a hospital designated as low, medium, or high security (including patients failing to return from section 17 leave of absence from hospital or absenting from escorted leave or detention under short-term powers of section 5, 135 or 136)

4.16 Human resources

The human resources department is responsible, in line with relevant employment policies, for external reporting to regulatory bodies for professionals including the general medical council (GMC), nursing and midwifery council (NMC), health and care professions council (HCPC) in conjunction with the relevant senior manager, and director or deputy director of nursing and allied health professions.

Referrals to the national clinical assessment service (NCAS), whose role is to help resolve performance concerns about dentists, doctors, and pharmacists, will also be dealt with under the employment policies route by the human resources department in conjunction with the relevant senior manager.

4.17 Learning disability registered home managers or supported living manager

In accordance with the relevant regulations of the Care Quality Commission (registration) Regulations 2009, the registered manager for the relevant home or supported living service is responsible for sending relevant notifications directly to the CQC within the required timescales.

4.18 Data protection officer or head of information governance

The data protection officer or head of information governance is responsible for reporting incidents to the relevant national regulatory body, for example, the Information Commissioner’s Office, Department of Health and Social Care, NHS Digital, NHS England, National Cyber Security Centre.

4.19 The trust Caldicott guardian

The trust Caldicott guardian (medical director) is responsible for ensuring that any patient identifiable information which may be used during the course of both the reporting and investigating of any incident is used and presented in a way which is proportionate and maintains the patients right to privacy.

4.20 Incident reporters

All staff are responsible for reporting all incidents on the trust electronic IR1 form via the Ulysses electronic incident reporting system, for example, accidents, incidents, health and safety issues, security issues, alleged clinical negligence or malpractice and alleged abuse of patients, staff and property.

Staff also need to be mindful of the fact that some incidents will require prompt and specific action to deal with the problem. This may include the following:

• summon emergency medical care if required
• summoning assistance from others if required
• ensuring that patients, staff, visitors, and others, are protected from the risk if required
• notifying senior members of staff on duty
• if equipment or machinery is involved, removing it from service (marking it clearly ‘out of order’) and arrange its repair or removal
• recording the action taken in the patient’s care records. Records might not be at hand, but they should be found and either tracked or made secure
• if necessary, request that all those who observed what happened prepare a witness statement as soon after the event as possible

4.21 Corporate SI review panel

The corporate SI review panel is responsible for the review of all SI investigation reports to assess the quality against its commissioner’s report criteria and advising lead investigators and the relevant care group director of changes or clarifications required prior to submission.

4.22 Mortality surveillance group

The mortality surveillance group meets monthly to review Mortality and victims of or perpetrators of homicide data across the trust, benchmark against published data and identify areas for investigation. The group aims to review all deaths that occur whilst in trust care or within a six-month period following discharge.

The groups terms of reference are to:

• review mortality and victims of or perpetrators of homicide data across the trust, benchmark against published data and identify areas for investigation
• reduce suicide rates by using mortality data to identify key risk groups or situations for suicide with the aim of targeting those groups or situations more effectively and thus reducing suicide rates
• reduce deaths in physical health patients contributed to by mental health difficulties by improved mental health screening in patients with long term conditions
• review community hospital deaths in order to reduce rates of avoidable deaths
• review community deaths in order to reduce the rates of avoidable deaths

4.23 Executive Management team

The role of the Executive Management team is to:

• review themes and trends in incident and serious incident reporting
• monitor compliance with action plans arising from serious incident investigations and seek assurance of risk mitigation for any actions not achieved in the agreed time frame
• provide assurance to the board of directors in relation to incident management, sharing of lessons learnt, and action taken to mitigate any identified risks.

This information is also provided to the quality committee through a monthly serious incident report, and the quarterly patient safety dashboards.

5 Procedure or implementation

It is essential that all incidents of all types (including near misses) are reported via the trust Ulysses incident reporting system (IR1), including any that the trust is required to report to external bodies.

If staff are in any doubt about the reporting of an incident, they should seek advice without delay to confirm reporting requirements from their manager or health and safety lead or directors.

5.1 What is an incident?

An NHS incident is described as any event which has given rise to potential or actual harm or injury, to patient dissatisfaction or to damage or loss of property.

A patient safety incident is any unintended or unexpected incident that could have, or did, lead to harm for one or more patients receiving NHS-funded healthcare.

A non-person incident is any unintended or unexpected incident involving trust property or private property whilst on trust premises. Any unintended or unwanted situation not directly related to staff, patient, visitor or contractor, any unintended or unwanted situation involving environmental issues.”

A near miss is defined as any patient safety incident that had the potential to cause harm but was prevented. However it can also encompass situations where an unexpected event had the potential to cause harm to someone, but by chance or design did not result in loss or injury.

A no harm incidents is an incident that occurred but did not cause harm

All deaths of people receiving NHS care, whether expected or not, are considered untoward occurrences and require reporting.

It also includes incidents resulting from negligent acts, deliberate or unforeseen.

For example:

• unexpected or unexplained death
• absconding by a detained patient
• a member of staff hurts their back
• a member of staff subject to verbal or physical abuse
• a member of the public falls in the car park
• fire on work premises
• theft, loss or damage to organisation or personal property.
• safeguarding

All untoward and unexpected occurrences should be reported on the Ulysses incident reporting system (IR1).

5.2 Who is responsible for reporting incidents?

Ideally, the member of staff involved in the incident should report it, both to a senior manager and on the incident reporting system. However, it is the responsibility of the senior person on duty at the time to ensure that it is reported.

Once the occurrence of the incident is made known to the service manager, it is their responsibility to ensure that the incident has been reported on the incident reporting system if not yet done so.

5.3 How to report an incident

The Ulysses risk management system (IR1 system) is an online, web based, incident reporting system that is used across the trust for all types of incidents, unexpected occurrences, and concerns.

All staff have access to the system for reporting, and to enter the system staff need to click on the safeguard (IR1) link then enter the username and password they have for general logging on.

The system is user friendly, and a number of guides are available to assist.

• Ulysses safeguard IRT (opens in new window) (staff access only)

For any queries or if seeking support, email the statistics co-ordinator who is part of the Patient Safety team at rdash.incidents@nhs.net.

If a member of staff feels that an incident requires a more urgent response or is of a serious nature, the manager or duty manager is to be contacted to discuss the incident, an IR1 report is to be entered as soon as practicable.

Incidents should be reported as soon as practicable, but within 24 hours of the incident occurring or staff becoming aware of it.

5.4 Incident grading

All incidents need to be screened to identify the appropriate level of investigation required to ensure that adequate fact finding, conclusions and, if necessary, action plans, are produced.

To aid the decision the incident reporting system has a risk matrix which calculates the risk from the severity and the likelihood of the incident repeating. This presents the risk as a grade and a colour.

There is also the ability for the trust to examine other parameters and decide that a particular level of investigation would be more suitable. For some incidents the level of investigation is determined by the requirements of external influences, for example the serious incident investigation process, never events, commissioner directives.

Incident grading rare

	Rare
Near-miss	Low
Non-harm	Low
Minor harm	Low
Moderate harm	Low
Major harm	Moderate
Catastrophic harm or death	Moderate

Incident grading unlikely

	Unlikely
Near-miss	Low
Non-harm	Low
Minor harm	Moderate
Moderate harm	Moderate
Major harm	High
Catastrophic harm or death	High

Incident grading possible

	Possible
Near-miss	Low
Non-harm	Low
Moderate harm	High
Major harm	High
Catastrophic harm or death	Extreme

Incident grading likely

	Likely
Near-miss	Low
Non-harm	Moderate
Moderate harm	High
Major harm	Extreme
Catastrophic harm or death	Extreme

Incident grading almost certain

	Almost certain
Near-miss	Low
Non-harm	Moderate
Moderate harm	Extreme
Major harm	Extreme
Catastrophic harm or death	Extreme

Risk likelihood guidance

Chance of occurrence	Frequency of occurrence
Almost certain, greater than 80%	Expected to occur at least daily
Likely, 60% to 80%	Expected to occur at least weekly
Possible, 40% to 60%	Expected to occur at least monthly
Unlikely, 20% to 40%	Expected to occur at least annually
Rare, less than 20%	Not expected to occur for years

The incident reporter is able to enter the criteria for this matrix, and the designated incident manager is able to enter their assessment of the criteria.

The final entry is the risk factor which is to be used to assess the level of investigation required.

However, the risk factor is not the only consideration, the designated incident manager or subject matter experts can use other considerations when deciding the level of investigation required.

The main considerations when making decisions about the investigation level are:

• the level of actual harm suffered
• the level of potential harm even if prevented
• the likelihood of the incident reoccurring
• the development of a trend of similar incidents
• whether the cause is suspicious
• whether the incident may lead to reputational damage
• if there is a possibility that the staff were negligent in their duties
• is there some other cause for concern which would benefit from a more in-depth investigation?

5.4.1 Actual impact of incident

Near miss, example incidents:

• I observed the patient was walking towards some water spilt on the floor in her room. I diverted her away from the spillage in case she would fall and cleaned up the water to make the floor safe
• a patient was observed starting to tie a shoelace around their neck, the potential ligature was removed

No harm, example incidents:

• the temperature in the office reached 29.5 degrees and made working conditions unbearable
• during depot administration the prefilled syringe neck snapped which rendered the injection unusable

Minor harm, example incidents:

• pressure ulcer category 2
• during PMVA training a staff member became off balance and pressed on facilitators back causing pain and discomfort

Moderate harm, example incidents:

• patient self-harmed with a broken glass bottle resulting in a visit to accident and emergency and surgery
• patient was found on floor and x-ray found arm fracture

Major harm, example incidents:

• I called a patient and he told me had taken an overdose of paracetamol, I asked another member of staff to contact an ambulance whilst I continued talking to the patient
• a patient attacked a member of staff with a knife resulting in surgery

Catastrophic, example incidents:

• a patient was found to have a grenade, the premises were evacuated, and bomb disposal squad called
• a fire broke out in a treatment room, the area was evacuated successfully, and the fire brigade attended however the building was destroyed

Death, example incidents:

• a patient committed suicide
• a patient had a seizure and passed away

5.5 Who receives notification of an incident?

On successful submission of an electronic form, a summary of the IR1 report is automatically emailed to:

• any pre-designated manager for the service or location
• the designated subject matter expert
• the statistics co-ordinator
• the incident holding file

For all incidents rated as resulting in moderate harm of above a summary is also emailed to the:

• relevant care group, deputy care group directors heads of service and corporate heads of services
• trust serious incident officer
• head of patient safety or patient safety specialist
• deputy director of nursing
• deputy director of safety and quality
• professional leads for the clinical profession (for example, occupational therapy)

5.6 What to do when you receive e-mail notification of an incident or occurrence

5.6.1 Designated incident manager

The designated incident manager will have computer access either laptop or desktop, which will enable them to access their services manage Incidents list.

When an incident on the list is clicked onto, brief details of the incident are opened and the managers form icon is available for the manager to click on to open the full incident form. The manager can then check all the details of the incident, amend where relevant, complete the severity and the incident outcome and submit. If any other changes are required, staff can contact the statistics co-ordinator.

The designated incident manager is responsible for the management and closure of the incident report.

The designated incident manager is to consider the incident and appraise whether it has reached the criteria for a serious incident. If they are unsure, they are to seek advice from the Patient Safety Investigation team.

If the incident is a patient safety incident, and the actual harm is of a moderate level or higher, then the duty of candour applies.

For incidents which do not reach the threshold for serious incidents, the manager should carry out an investigation of a scale and scope which is proportionate to the incident to ensure that resources are effectively used and conducted to identify:

• the cause of the incident
• whether the incident can be prevented from occurring again
• the action taken to manage the incident
• whether the actions taken were suitable and sufficient to manage the incident effectively
• any post incident actions, including further management, learning and changes to systems and practices which may prevent or mitigate a future occurrence

Any investigation should be of a suitable thoroughness to achieve the aims above.

The investigation should be based upon the root cause analysis process and may range from simple fact finding to a full investigation.

The manager is to summarise the findings of the investigation in the outcomes and recommendation sections of the incident reporting system.

5.6.2 The subject matter expert

Each incident report is forwarded to a relevant subject matter expert, for example:

• security, trust security advisor
• violence, reducing Restrictive Interventions team
• falls, trust falls prevention lead
• sudden collapse, trust resuscitation officer
• safeguarding, Safeguarding team representative
• professional leads (for example, occupational therapy)

The subject matter expert is to read the incident report and provide assistance, guidance, or other support as required to the designated incident manager and, or people involved in the incident. This may include providing support or seeking further information or clarification or carrying out an investigation. Where possible this should be within 21 days of staff having received the notification for incidents of near miss, minor harm, 28 days for moderate incidents and within 60 days for severe and death incidents.

The subject matter expert should ensure that any learning from the incident has been taken and managed effectively.

The subject matter expert is not too close any incident other than those for which they are also the nominated manager.

They should assist in any investigation which may take place into the causes and management of the incident.

5.7 What are the time periods for incident management?

Upon receipt of the email notification of an incident occurrence, the subject matter expert should review the incident and contact the manager to discuss the incident, or to provide advice on how to proceed, within 10 working days.

The completion of the investigation and closure of the incident on the reporting system by the designated incident manager should take no longer than 21 working days for near miss to minor harm, 28 days for moderate harm and 60 for major harm and, or death.

The closure targets can be extended if the incident investigation is complex, or there is a delay in obtaining information.

In cases where the incident becomes subject to any of the following:

• serious incident process
• external investigation
• investigation by the police or coroner
• investigation by some other statutory body

As there is no further action that the manager can take, they are to close the incident making a note of the fact that the incident is now subject to one of the above. Investigation outcomes will then be subject to monitoring and reporting as detailed in section 5.11 of this policy.

5.8 Duty of candour

In order to meet this duty the trust must:

• act in an open and transparent way with the relevant person in relation to care and treatment provided to people who use our services in carrying out a regulated activity
• tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable patient safety incident (PSI) has occurred and provide support to them in relation to the incident, including when giving the notification
• provide an account of the incident, which to the best of its knowledge is true, of all the facts that it knows about the incident as at the date of notification
• advise the relevant person what further enquiries it believes are appropriate
• offer an apology
• follow this up by giving the same information in writing and providing an update on the enquiries
• keep a written record of all communication with the relevant person

The trust’s being open policy (incorporating the duty of candour) is available on the intranet and details the policy and procedures required for meeting the duty, information on offering an apology and a process flowchart to assist decision making following a patient safety incident.

Further information on the duty of candour can be found in the being open policy (incorporating the duty of candour).

5.9 The trusts external reporting arrangements

The trust is required to report certain types of incident to a range of external agencies. All incident reports are scrutinised by the health and safety lead in order that the relevant external reporting requirements are met.

The main external agencies to which the trust reports incidents are listed below (please note this is not an exhaustive list, and advice will be taken by the health and safety lead in conjunction with other relevant managers, on particular issues).

5.9.1 Reporting of injuries, diseases and dangerous occurrence regulations (RIDDOR) 2013

• RIDDOR requires the reporting of incidents of a specified nature to the Health and Safety Executive (HSE), using standard forms F2508 and F2508A.
• The most common report is for injuries to staff which result in an absence from duty of more than 7 consecutive days. This requires completion of form F2508.
• Dangerous occurrences such as failure of lifting equipment, explosion, and failure of supporting structures also require completion of form F2508.
• The reporting of diseases requires completion of form F2508A. The disease has to be diagnosed by a medical practitioner.
• The guidance to the regulations has appendices, which list the types of injury, diseases and dangerous occurrence that need to be reported.
• The manager of the area where the incident took place is responsible for completing the RIDDOR report and forwarding it to the statistics co-ordinator who submits it to the HSE and copies it to the health and safety lead. The health and safety lead will assist and advise if required.
• If there is any doubt, reference should be made to the guidance, or the health and safety lead contacted for advice.

5.9.2 National reporting and learning system (NRLS)

The statistics co-ordinator within the Patient Safety Investigation team submits the relevant patient safety incident information through the e-form to the national reporting and learning system (NRLS).

This includes the notifications which are required by law to be reported to the NRLS who will then notify the Care Quality Commission.

5.9.3 NHS estates

The trust is required to report incidents relating to fire, buildings, plant, and non-medical equipment to NHS estates.

Managers dealing with such incidents must contact the head of estates and facilities with all the relevant information to enable the health and safety lead to complete the required report form.

5.9.4 Medicines and healthcare products regulatory agency (MHRA)

Any incident relating to medical equipment should be notified formally to the MHRA using the relevant form supplied by that office.

Managers in those areas affected can report directly to the MHRA.

Incidents relating to adverse drug reactions are reportable on the yellow forms. Reporting can be done electronically via the  yellow card website (opens in new window).

5.9.5 NHS resolution

Incidents where there are likely to be civil claims require, where practicable, to be notified to NHS resolution as early as possible.

Managers should inform the Patient Safety Investigation team for clinical claims and the health and safety lead for non-clinical claims, supported by the submission of an electronic incident form (IR1) to enable as much information to be gathered prior to reporting.

The trust claims manager (head of patient safety or patient safety specialist) will contact NHS resolution as appropriate.

5.9.6 Environmental health office and food standards agency

Incidents relating to food will, in addition to being notified internally using the electronic incident form (IR1) be notified to the local environmental health office of the local authority and the Food Standards Agency by the catering manager.

5.9.7 Police

Criminal incidents will, by their nature, be reported to the police. These may include assaults, actual or threatened, hate crimes, theft, vandalism, suspicious activity, or deaths.

It is the responsibility of the person affected, or the manager on behalf of the trust, to report the incident to the police via 101, or 999 if an emergency. If necessary, the Health and Safety team can advise and assist a member of staff or manager to report.

An electronic incident form (IR1) must be completed for all incidents reported to the police.

5.9.8 NHS improvement

NHS Improvement has a statutory duty to assess, authorise and regulate NHS Foundation trusts. Incidents of concern are highlighted to NHS Improvement by the chief executive officer, deputy chief executive or trust board secretary as required.

5.9.9 Care Quality Commission (CQC), mental health notifications

The incident reporter is able to enter the criteria for this matrix, and the designated incident manager is able to enter their assessment of the criteria.

The final entry is the risk factor which is to be used to assess the level of investigation required.

However, the risk factor is not the only consideration, the designated incident manager or subject matter experts can use other considerations when deciding the level of investigation required. The main considerations when making decisions about the investigation are:

• incident to be reported to CQC:
  • the death of a patient detained or liable to be detained under the Mental Health Act 1983
  • the unauthorised absence of a patient detained or liable to be detained under the Mental Health Act 1983 from a secure ward
  • any application and outcome made to a supervisory body in relation to depriving a service user of their liberty
  • the admission of a child or young person to an adult psychiatric ward or unit
• trust policy to be referred to for full detail of reporting:
  • learning from deaths policy the right thing to do
  • patients missing or absent without leave (AWOL) policy
  • MCA deprivation of liberty (DoL) policy
  • care and treatment of children under the age of 18 on adult acute mental health inpatient areas policy
• Detail of regulation under which this reporting requirement:
  • regulation 17 of the Care Quality Commission (Registration) Regulations 2009
  • regulation 17 of the Care Quality Commission (Registration) Regulations 2009
  • regulation 18 of the Care Quality Commission (Registration) Regulations 2009
  • regulation 18 of the Care Quality Commission (Registration) Regulations 2009

The following must be reported directly to the CQC without delay:

• for deaths of detained patients and the admission of a child or young person to an adult psychiatric ward or unit, the mental health act manager is responsible for notifying the CQC.
• for service users who are absent without leave from a secure ward, the nurse in charge is responsible for notifying the CQC, see patients missing or absent without leave (AWOL) policy

5.9.10 Regulatory bodies for professionals

Reporting to regulatory bodies for professionals including the:

• general medical council (GMC)
• nursing and midwifery council (NMC)
• health and care professions council (HCPC)

These are dealt with under the employment policies route by the human resources department in conjunction with the relevant senior manager, medical director or director or deputy director of nursing and allied health professions.

5.9.11 National clinical assessment service (NCAS)

Referrals to the national clinical assessment service (NCAS), whose role is to help resolve performance concerns about dentists, doctors, and pharmacists, are dealt with under the employment policies route by the human resources department in conjunction with the relevant senior manager.

5.9.12 NHS England (via STEIS)

Serious incidents (SIs) are reported via the strategic executive information system (STEIS). Incidents are reported to the serious incident officer who is part of the Patient Safety Investigation team.

Please refer to section 5.10.5 of this policy for guidance on serious incidents which may meet the criteria for STEIS reporting.

5.9.13 NHS counter fraud authority (formerly NHS protect)

In accordance with NHS Counter Fraud Authority requirements, incidents of fraud, corruption, and security breaches should be reported via the local counter fraud specialist. For further guidance see the counter fraud, bribery and corruption policy.

The local security management specialist (LSMS) will report incidents of and theft, damage, security breaches and violence and aggression against staff to NHS Counter Fraud Authority.

5.9.14 Information commissioner

Staff should refer to the data security and protection breaches or information governance incident reporting policy or information governance incident reporting policy, RDaSH NHS Foundation Trust a copy of the guide to the notification of Data Security and Protection Incidents from NHS Digital (opens in new window).

5.9.15 Coroner’s office

In the following cases if the death has not already been reported to the coroner by another agency such as the police there is a statutory duty on healthcare providers to refer the death to the local coroner:

• suicide of an inpatient
• suicide of a patient in the community
• suicide of a person within 6 months of discharge from service
• if the deceased was subject to detention under MHA 1983 including community treatment orders
• if the deceased was under 18
• if the death was due to occupational injury or disease
• if the death is due to homicide
• if the death is unexplained

This list is not exhaustive, and if there is any doubt advice should be sought from the local coroner’s office.

5.9.16 Death of a person with a learning disability

Deaths of patients with a diagnosis of learning disability are the be reported by the service manager to the LeDeR programme via the online reporting tool (opens in new window).

A local review is to be completed as soon as practicable using the mortality review.

5.10 Investigation process

5.10.1 Mortality reviews

Concern about patient safety and scrutiny of mortality rates has intensified with investigations into NHS hospital failures that have taken place over the last few years.

As a result there is an increased drive for NHS trust boards to be assured that deaths are reviewed and appropriate changes made to ensure patients are safe, and the trust has in place a learning from deaths policy the right thing to do to which staff are to refer for detailed guidance on undertaking mortality reviews.

All deaths of patients for whom we are the main provider (as defined in the learning from deaths policy the right thing to do, see quick ref flow chart in appendix B) are to be reported using the IR1 online reporting form. It is required whether a patient is an inpatient or outpatient and includes all patients who die within 6 months of discharge from our services.

In brief the review requirements under the learning from deaths policy the right thing to do are as follows:

• unexpected deaths, or deaths which meet the criteria of the coroner staff are to follow the structured review process as set out in this policy
• expected deaths due to natural causes, IR1 to be reviewed by at least a band 7 manager to ensure the death was expected, and that the care provided by the trust was suitable and sufficient:
  • no concerns noted, IR1 to be closed down by the manager
  • issues identified, structured review to be undertaken
• unexpected deaths, but due to natural causes, structured review to be undertaken

The trust has in place a mortality reporting and review process to identify any shortcomings in care provision or systems and provide assurance to the trust board that deaths are effectively reviewed.

5.10.2 Review of “trust acquired” pressure ulcers graded at level 3 or above.

For full guidance staff are to refer to the trust pressure ulcers, detection, prevention and treatment policy. When a trust acquired pressure ulcer is assessed as a category 3 or above, a structured review must be undertaken.  These details of the root cause of the pressure ulcer are recorded on a structured review template which is submitted to the pressure ulcer structured review panel for scrutiny to provide assurance that appropriate care has been provided by the team.

A structured review is completed for all pressure ulcers assessed as category 3 and 4.  After discussion and consideration by the panel, the following possible cause outcomes are agreed:

• lapse in care with localised learning
• serious lapse in care with trust wide learning outcomes (previously reported as avoidable) to progress through the serious incident procedure
• no lapse in care, this is where no service failings have been identified

Pressure ulcer review data is reported to the care groups via the monthly and quarterly patient safety dashboards.

5.10.2.1 Review of “present on admission” pressure ulcers

The review of “present on admission pressure ulcers” does not fall within the remit of the Pressure Ulcer Structured Review Panel. Those agencies where the pressure ulcer was inherited from have a duty to report and investigate these within their own current service provision.

5.10.3 Incidents rated low which don’t reach the duty of candour threshold

These are usually the least serious and the most frequently reported incidents.

They will usually be reviewed and managed within the Service.

The designated incident manager (or nominated deputy) of a team will:

• review the grading and actions already taken identified on the incident report form (IR1), check the accuracy and completeness of the report
• complete the risk matrix to ascertain the suggested level of investigation
• in most cases the incident will have been effectively managed and adequate actions taken by the staff present at the time as recorded on the incident report form, the manager is to make an entry in the managers outcome section confirming that the incident was effectively managed and what, if any, further actions are required
• If further investigation or actions are needed the manager will nominate a member of staff (if not themselves) to carry out this task and report back.
• seek advice and support from subject matter experts as necessary
• ensure any further investigation is completed and that any necessary changes are implemented
• complete the manager’s outcome section on the IR1 with the outcome of the investigation
• record any additional learning
• inform the senior manager for the service of any significant learning or service improvement for sharing with other teams and services
• escalate any risks or issues to service manager
• feedback to any staff members involved

However if any themes or trends are identified from low rated incidents a thematic structured review should be undertaken by the trust central investigation team.

5.10.3.1 Investigation of non-clinical incidents

In the majority of instances, incidents will be minor or near miss and the cause of the incident will be clear. It is the responsibility of the relevant manager to ensure that any incidents that occur in their area of responsibility are investigated and the appropriate remedial action is taken to ensure, as far as possible, there is no recurrence. Investigation of non-clinical incidents follow the same process of clinical incidents using Ulysses and non-clinical health and safety incidents will be investigated as is appropriate to the degree of injury or illness or property damage or seriousness of the near miss.

Serious accidents, such as those that result in serious injury or staff absence are likely to be reportable under the Reporting of Injuries, Diseases, and Dangerous Occurrences Regulations (RIDDOR). These incidents will be investigated using root cause analysis and a report made to the health and safety executive (HSE) by the trust’s health and safety lead.

The Health and Safety team are available to support managers and others on matters which might reasonably lie outside the competence of those carrying out an incident investigation.

5.10.4 Incidents rated moderate, or above which meet the duty of candour threshold

All incidents rated at this level which are not subject to review via:

• mortality review
• pressure ulcer review panel

Will have a structured case review completed.

The incident is to be reported on the IR1 system in the usual way.

Within 3 working days the care group director will allocate a minimum of 2 case reviewers at band 7 or above, one of whom must be from outside the team directly involved in the incident to undertake a structured case review. Staff leading the structured review will be trained in RCA, and, or have a high level of investigating experience.

The structured review tool is a word template which is available from the serious incidents officer or on the L Drive as follows:

• access the L drive
• click on the SI file
• once in the SI file click on structured review
• in this file you will find a folder for each care group
• save a copy of the master structured review workbook in the relevant year folder under the incident number and it is this copy that the review details are to be entered onto

5.10.4.1 Review outcomes

The outcome of the structured review will determine if any further investigation is required, and the reviews will be rated as follows:

• no areas of concern found in relation to care delivery, or acts or omissions of staff
• some low-level concerns identified which can be addressed through individual or team reflection with the ward or team manager
• concerns identified which whilst not felt to have directly impacted on the outcome of the incident are felt to require a table top review with an external facilitator, in these cases the review will be facilitated by one of the trust lead investigators
• significant concerns have been identified which require a full serious incident review to be undertaken

5.10.4.2 Sign off process for the structured reviews

Once the structured review has been completed it is to be reviewed and signed off by the modern matron or team manager who will then inform the care group director that it is ready for them to review and sign off.

If the care group director is satisfied that the structured review has considered all issues and a robust decision made, they are to sign it off and notify the serious incident officer that they have signed it off for review by the central investigation team.

In the event of the care group director having any queries or feeling information is missing in relation to the structured review they are to contact the modern matron or service manager who did the first stage of the sign off to discuss their findings and agree what steps need to be taken and the time frame for completion in relation to addressing any queries or gaps in information.

The structured review should be fully completed and signed off by the care group within 28 days of the incident having occurred unless it is a severe incident which is within 60 days. In the event that the required days are to be breached for any reason the care group director is to notify the serious incident officer.

Once the structured review has been signed off by the care group director it will be reviewed by the Central Investigation team at their morning meeting. The result of this review can be:

• decision of care group felt to be proportionate with the right level of action or learning taken, in this case no further action will be required
• that further information is needed in relation to some aspects of the structured review, in this case a full serious incident investigation will be undertaken, however the remit of the serious incident investigation will be to concentrate on the aspects of the structured review where gaps in information or concerns had been identified
• identification of themes or cluster incidents occurring across more than one care group which require a serious incident investigation

5.10.5 Serious incidents

The occurrence of a serious incident may demonstrate weaknesses in a system or process that need to be addressed to prevent future incidents. Serious incidents may lead to avoidable death or serious harm to patients or staff, future incidents of abuse to patients or staff, or future significant reputational damage to the organisations involved.

Serious incidents therefore require investigation in order to identify the factors that contributed towards the incident occurring and the fundamental issues (or root causes) that underpinned these. Serious Incidents can be isolated, single events or multiple linked or unlinked events signalling systemic failures within a commissioning or health system.

There is no definitive list of events or incidents that constitute a serious incident (and lists should not be created locally as this can lead to inconsistent or inappropriate management of incidents). Where lists are created there is a tendency to not appropriately investigate things that are not on the list even when they should be investigated, and equally a tendency to undertake full investigations of incidents where that may not be warranted simply because they seem to fit a description of an incident on a list.

The definition below sets out circumstances in which a serious incident must be declared.

Every incident must be considered on a case-by-case basis using the description below. Inevitably, there will be borderline cases that rely on the judgement of the people involved.

5.10.5.1 Serious incident definition

Acts and, or omissions occurring as part of NHS-funded healthcare (including in the community) that result in:

• unexpected or avoidable death of one or more people. This includes:
  • suicide or self-inflicted death
  • homicide by a person in receipt of mental health care within the recent past
• unexpected or avoidable injury to one or more people that has resulted in serious harm
• unexpected or avoidable injury to one or more people that requires further treatment by a healthcare professional in order to prevent:
  • the death of the service user
  • serious harm
• actual or alleged abuse; sexual abuse, physical or psychological ill treatment, or acts of omission which constitute neglect, exploitation, financial or material abuse, discriminative and organisational abuse, self-neglect, domestic abuse, human trafficking, and modern-day slavery where:
  • healthcare did not take appropriate action or intervention to safeguard against such abuse occurring
  • where abuse occurred during the provision of NHS-funded care
• A never event, all never events are defined as serious incidents although not all never events necessarily result in serious harm or death (please refer to appendix C for the current list of never events)
• an incident (or series of incidents) that prevents, or threatens to prevent, an organisation’s ability to continue to deliver an acceptable quality of healthcare services, including (but not limited to) the following:
  • failures in the security, integrity, accuracy, or availability of information often described as data loss and, or information governance related issues
  • property damage
  • security breach or concern
• incidents in population-wide healthcare activities like screening and immunisation programmes where the potential for harm may extend to a large population
• inappropriate enforcement or care under the Mental Health Act (1983) and the Mental Capacity Act (2005) including Mental Capacity Act, Deprivation of Liberty Safeguards (MCA DOLS)
• systematic failure to provide an acceptable standard of safe care (this may include incidents, or series of incidents, which necessitate ward or unit closure or suspension of services)
• activation of major incident plan (by provider, commissioner relevant agency)
• major loss of confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation

For further detail and explanation, please see the NHS England Serious Incident Framework.

At the time of writing this policy, the framework can be found on the NHS England website (opens in new window).

Once identified as a serious incident it then becomes the responsibility of the director of nursing and allied health professions, and any further investigation beyond the structured review will be undertaken by a Lead Investigator based in the Patient Safety Investigation team. In some cases an investigation team may need to be established consisting of suitable specialists, a medical advisor. to ensure the investigation is thorough and encompassing.

These are defined in the serious incident framework as grade 2, Level 2 Comprehensive RCA Investigations.

For all serious incident investigations the investigation terms of reference will be clearly defined and, in all cases, include the following:

• for inpatient services the staffing levels at the time of the incident (please note this will be for all disciplines)
• staffing levels and caseload numbers for community services
• review and analysis of staffing levels at the time of the incident (all clinical staff not just nurses)
• for inpatient services the level of clinical activity on the ward at the time of the incident and consideration of general patient dependency and acuity
• determination as to whether or not the staffing levels were sufficient to meet patient or service need
• analysis of any impact staffing levels had on the incident

5.10.6 Very serious incidents

These will include but may not be restricted to incidents such as homicides. In these cases an internal serious incident investigation will be undertaken by one the trust Lead Investigators, which will be followed by an independent investigation managed by the director of nursing and allied health professions and the chief executive’s office on behalf of the trust board.

The requirement for an independent investigation will be decided by NHS England, the integrated care board, or the chief executive officer.

NHS England, the integrated care board, the trust, and other organisations should come to local agreement with respect to arrangements for funding and supporting independent investigations. An early meeting with all the stakeholders involving the senior manager should take place to agree a common approach to:

• the timing of investigation
• sharing of information, including issues of confidentiality
• communication with families, carers, staff, and media

The trust would be responsible for obtaining service users’ consent for release of their notes to the investigation team.

These incidents are classed as grade 2, level 3 independent Investigations within the serious incident framework (2015).

5.10.7 Guidance on the preservation or recording of evidence

When undertaking any level of investigation it is important that all evidence used to inform decision making is obtained as close to the event having taken place as is possible. Whilst the evidence used will vary dependent on the nature of the event and type of investigation undertaken steps must be taken to ensure that the evidence is well documented and accurate.

Below are examples of evidence types, but this is not an exhaustive list.

5.10.7.1 Scenes of crime

In any incident which is suspected to be as a result of a crime the area is to be immediately secured, and nothing touched, or moved until police permission is given to do so.

5.10.7.2 Memory capture

This differs from a statement in that it is where staff are asked to make a written record of a whole shift and the event that took place, not just the actual incident. There is no structure to it as it is important that the staff member records their memory of the shift and things that stood out to them. It needs to be as soon as possible following the event .and is a useful way for an investigator to gain a wider understanding of what was happening leading up to an incident.

5.10.7.3 Photos

The use of photos is useful as it enables a visual presentation of key aspects of an investigation. However when using photos it is important that:

• the photos are taken with a camera that records the date it was taken
• if measurements are to be included in the investigation report the photos should be taken with a ruler or tape measure in place to show size, depth.

5.10.7.4 Devices

Where any incident involves the failure of any equipment, medical device, furniture, or fabric of a building, where possible, and if safe to do so photos should be taken and the item or area must be immediately cordoned off, access controlled, and advice sought from the trust health and safety lead or team.

5.10.7.5 Staff statements

If staff are asked to provide a written statement in relation to an incident:

• the investigator must be clear as to why the statement is being requested, the parameters of the statement content, and how the information in the statement will be used
• the staff member is to be reminded to only state fact in their statement and not to relay on hearsay or opinions that cannot be backed up by clinical evidence
• all statements used in an investigation must be signed by the staff member and dated

5.10.7.6 Staff interviews

Interviews are useful in that they enable the investigator to question for further detail and clarify verbal statements or reasons for actions having been taken. At all interviews a record is to be made of the discussion that takes place. These notes are to be typed up and a copy sent to the staff member for them to check the content accuracy.

The staff member should then be asked to return a signed copy to the investigator.

Should any amendments be requested the staff member is to make these on the copy they received, sign the amendments, and return to the investigator. If the investigator agrees with the amendments, these are to be made and a new copy of the interview records issued to the staff member for them to sign and return. The copy of the interview notes with the staff member’s amendments on will be scanned into the investigation file.

In the event that the investigator does not agree that the requested amendments reflect the discussion which took place at the interview the investigator should in the first instance speak with the staff member to agree the amendments. If agreement cannot be reached advice is to be sought from HR.

5.10.8 Action to take if during the course of a serious Incident Investigation concerns are identified in relation to a staff members clinical practise, behaviour, or attitude

In these circumstances the Lead Investigator must immediately inform the persons line manager so that a decision can be made in relation to any clinical risk posed and required action to mitigate any identified risk.

In the absence of the staff members line manager the care group director or care group nurse director and are to be informed.

If the concerns relate to a member of medical staffing the care group medical director for the care group is to be contacted or in their absence the trust medical director.

If the concerns relate to a profession (for example, physiotherapy, occupation therapy, nursing) the professional lead is to be contacted.

If it is an agency staff member contact must be made with the employing agency to inform them of the concerns that have been identified.

5.10.9 Undertaking a serious incident investigation which is also subject to a police investigation

There will be some incidents which the trust needs to investigate that are also subject to a criminal investigation by the police. In these cases it is important that no action is taken by the trust which could be seen as tainting or interfering with evidence and as a result potentially jeopardise any future court trail.

However it is also not acceptable for no action to be taken due to the incident being subject to a police investigation as following any incident the trust is responsible for ensuring its policies and processes promote safe service delivery. Therefore the lead investigator must:

• undertake a clinical records or document review
• establish contact with a named police officer with whom they can liaise as to the progress or timeframes of the police investigation, a record is to be kept of all contact with the police, including what was asked and the response provided
• establish if there are any staff they can interview as part of the trust investigation who are not part of the police investigation

Ascertain with the police if they are able to undertake staff interviews within the parameters of a pre agreed set of interview questions.

5.10.10 Conducting investigations when other health care providers are also involved

In cases where more than one organisation is involved in the care and service delivery the organisation which initially identifies the serious incident is responsible for alerting other providers, commissioners and partner organisations and initiating a discussion about any required investigation and subsequent action.

Where possible and appropriate all organisations and agencies involved in care delivery should work together to undertake a single investigation.

If due to the complexities of the case a single investigation is not possible separate investigations will be undertaken by each organisation. However in this case it is important that investigators inform partner organisations of any issues identified which are as a direct result of their processes or staff actions.

5.10.11 Management of a serious incident investigation which is also subject to a formal complaint

In these cases the lead investigator will undertake one investigation, the findings of which will inform both the Serious Incident report and complaint response.

Where appropriate the Lead Investigator will also agree with the complainant how much of their complaint will be answered as part of the SI investigation and subsequent report, and what aspects will require a separate response due to being outside the remit of the SI investigation. It will also be made clear to the complainant that the response to the compliant is unlikely to be issued within the 40-day time period as we won’t be in a position to fully answer their compliant until the SI investigation is concluded.

5.10.12 Serious health and safety incidents

All health and safety incidents must be reported via the trust’s electronic IR1 form using the Ulysses incident reporting system. However, there is a legal requirement to report serious incidents externally to the health and safety executive (HSE). Serious health and safety incidents include deaths, some types of serious injury, some occupational diseases and dangerous occurrences that arise as a result of or in connection with work activities. This would include injuries to staff as well as patients, visitors and any other person who is injured as a result of trust work activities. For example, if a visitor falls over a wheelchair left in a corridor and is injured. If the person is taken directly to hospital due to the injury, this would be reportable to the HSE. However, if the person did not want to go to hospital, a report to HSE would not be required. The criteria for reporting to HSE would be that there was an injury, and the injured person went directly to hospital from the location where the injury occurred.

5.11 Serious incident action plans

5.11.1 Action plan development

For any investigation which is undertaken independently of the care group the investigator will make recommendations based on their investigation findings, and it is the responsibility of the care groups to work in conjunction with the relevant ward or service manager to put in place an action plan to address the recommendations which meets the principles of being:

• SMART
• specific
• measurable
• achievable
• realistic
• timely

5.11.2 Monitoring of action plan implementation

The care group director will be responsible for submitting a copy of the action plan to the trust Central Investigation team.

All action plans will be held on a central data base, and the serious incident officer will be responsible for:

• alerting the relevant action lead of any actions they are responsible for which are due for completion
• seeking an explanation as to why any actions will not be completed within the agreed timeframe
• escalating to the head of patient safety any actions which will not be completed in the agreed timeframe so that there can be a review of any risk posed as a result of the slippage on completion
• where required gathering and archiving evidence of action plan completion

On a monthly basis undertaking a random audit of completed actions plans to test the evidence of completion.

5.11.3 Reporting of action plan implementation

Compliance of action plan completion is reported to the quality committee on a monthly basis in the serious incident report.

5.11.4 Process for the sign off of homicide action plans

All Homicide reports and associated action plans are filed centrally within the trust Investigation team. A month prior to the date any action is due for completion the trust Investigation team will liaise with the relevant group director to collate evidence of completion against any due actions.

Once all the evidence has been logged onto the central data base against each action on the plan the following steps will be undertaken:

1. the evidence will be reviewed by the central investigation team and cross referenced to the relevant actions, where gaps in evidence are found a request will be made to the care group director for further evidence to be provided
2. Service visits will be undertaken by staff from nursing and quality in conjunction with an care group nursing director from outside the care group where the incident occurred to test the evidence in practice
3. a briefing reports of the findings from step 1 and 2 will be prepared, the report will highlight assurance of completion of actions, gaps and actions taken to mitigate any gaps in evidence
4. briefing report to be reviewed by the medical director and director of nursing to determine if the evidence of action completion is robust enough to recommend closure of the action plan, the relevant care group director and chief operating officer will be notified of the outcome from this review
5. report will be presented to the quality committee detailing the review findings and recommendation that the action plan is either closed or requires further work to be undertaken within the service

5.12 Involving relatives and carers in investigations

If the incident is subject to a full serious incident investigation the lead investigator will contact the person and or their family to offer them the opportunity to both contribute to the investigation and ask any questions they may have in relation to the incident. As it is likely that the patient or family will have already established a relationship with the nominated contact person from the clinical services it is advisable that at least in the first instance a joint visit is undertaken. Once the lead investigator has established the patient or family expectations of the investigation they will be responsible for:

• agreeing the level of contact they wish to receive
• keeping them updated as to the progress of the investigation at the agreed times
• ensuring that any questions they raised have either been answered, or that they have been provided with a full explanation as to why their queries could not be addressed as part of the investigation
• feeding back the outcome of their investigation

If the initial or further contact is declined by the person or their family, further attempts at contact are to be made, and a record kept of when and how contact was attempted. This may be in the form of a letter on conclusion of the investigation to let them know that the trust is now in a position to share the investigation outcome with them, and who to contact to make the necessary arrangements to receive this feedback.

5.13 Support to staff involved in an incident

5.13.1 Immediate support

At the time of the incident the most senior person on duty will be responsible for identifying any immediate support needs that the staff may have this may include the following:

• attendance at the local accident and emergency department
• administration of first aid
• emotional support
• support during any police interviews
• arranging additional staffing from adjacent wards
• enquiring if staff on the next shift can come in early
• arrangements being made for them to leave duty

5.13.2 Addressing psychological support needs

Involvement in a serious incident can have significant consequences on the staff and patients involved. People may experience a range of reactions from stress, shame, guilt, and sadness. It should also be recognised that different individuals will have differing responses to the same incident and therefore a range of different psychological support options need to be made available in the early stages after an incident and also in the coming weeks. Patient and staff welfare must be considered, particularly in relation to psychological trauma and stress, support is therefore made available on both a group and individual level. The following services are enabled to psychologically support people involved in an incident:

• any patient or staff member who has been involved in a particularly stressful or distressing incident will receive support if required following the incident from a manager who is either involved in the incident or who has been contacted in relation to the incident
• in a situation where more than one person is involved in the serious incident, people involved will be provided with the opportunity to be supported if required as an individual or a group
• specific psychological support may be required after certain incidents, where this is the case the manager of the service currently provides support for patients via internal clinical staff and can provide support for staff in the form of a reflective session and if appropriate a debrief using either internal RDaSH psychological staff or via commissioned services through the occupational health team
• the RDaSH Spiritual Care team are available to provide support for patients, staff, and families after an incident, this support can be provided face to face or via the telephone if required
• Individuals involved in safety incidents may wish for an individual discussion about safety planning or access to safety resources (for example, attack alarms) this can be facilitated by our RDaSH Health and Safety team. Contact with this team can either by via the team manager or from individual staff
• individual employees can request support from Occupational Health, this support may include counselling or a specific talking therapy
• all staff have access to a full range of well-being services through the health and wellbeing pages on the RDaSH intranet pages
• when the incident involves a restraint or resuscitation specific support can be provided by the learning and development team specialist trainers, these trainers can either provide remote support or attend the service areas and can provide patient and staff support

5.14 Support to other service users who may be affected by the Incident

If an incident occurs on an inpatient ward, it is likely that other patients may be distressed either as a result of having directly witnessed the incident or due to them having formed an acquaintance with the patient involved in the incident.

In these circumstances it is important that ward staff:

• provide them with the opportunity to discuss how they feel and ask any questions they may have
• agree with them what ongoing support they may need
• review the risk assessment
• consider if the incident has any impact on the patients’ risk profile, including the potential risk of copying behaviour

5.15 Support to relatives and carers

Once the immediate response to an incident has been progressed (for example, no later than on the following working day) a senior staff member should be confirmed by the care group director as responsible for communicating with the person involved in the incident and or their family. The selection of this person should consider the family’s feelings and any communication needs they may have and possess the skills to enable them to act with openness and empathy.

In the event of the incident progressing to a full serious incident investigation the person nominated as the family contact person by the care group director will work with the lead investigator to provide ongoing support and continuity.

In the case of a patient death due to suspected suicide the relative is to be provided with a copy of the booklet “support for families and carers following a sudden death.”

It is also important that the patient or family are made aware of what additional support is available to them this can include:

• advocacy services
• access to interpreters
• access to local support groups
• consideration as to whether or not the relative may require a referral into services for bereavement counselling or anxiety management

In the case of a relative or carer who is already in receipt of trust services contact is to be made with their relevant care coordinator or clinical team to alert them to the fact that the person may require additional support and, or review of their risk assessment.

5.16 Learning from incidents

A key outcome from the investigation of incidents is for the organisation to critically evaluate the care provided and extract learning which can be shared to minimise the risk of a similar incident occurring.

However it is recognised that this learning has to take place across all levels in the trust and be provided flexibly to meet the needs of a diverse workforce.

In addition learning needs to be shared with external agencies, including the local commissioners.

Within the trust there are number of ways in which learning form incidents is shared and these can be seen in appendix D.

5.17 Incident reporting and monitoring arrangements

All incidents reported on the IR1 system are monitored by the Patient Safety team and the following data is included on the monthly patient safety dashboards which go to each care group for discussion in their governance meetings and at the ward or clinical team meetings:

• total number of incidents reported by level of harm
• number of unclosed incidents
• compliance with the duty of candour requirements
• number of serious incidents by category
• number of action plans in place from SI investigations, and the number of actions that are overdue

From the care groups the dashboards go to the quality operational management meeting and are shared with the local commissioners at the monthly quality meetings and amalgamated into a trust wide quarterly patient safety dashboard which is presented to the trust quality committee.

The quality committee also receives a monthly SI report, and as required outcome reports from table top reviews and deep dive reports.

In addition the following reporting arrangements are also in place:

• mortality reports are presented to the mortality review group
• pressure ulcer data and review outcomes is included in the patient safety Dashboard and presented to the pressure ulcer harm minimisation steering group

5.18 Dealing with media enquiries

The head of communications will be briefed by the head of patient safety or patient safety specialist concerning incidents which may attract media interest. The head of communications or a team member will be responsible for the preparation of a “press statement” which will be approved by the relevant director(s). The Communication team will work closely with organisational staff to determine the precise nature, frequency, and content of such communication.

5.19 Staff who wish to raise a concern

There may be occasions when a member of staff witnesses or becomes aware of something within the trust that gives them cause for concern. In these circumstances the member of staff should:

• make an immediate note of their concern, recording relevant details such as what was said or witnessed, date, time and details of other people involved
• raise their concern with their manager and, or refer to the trust’s freedom of information and environmental information regulations which provides further guidance

6 Training implications

It is important that all staff involved in the incident management process are familiar with this policy and that its purpose and principles are well understood, and the associated procedures are rigorously applied.

All patient safety lead Investigators are required to have had or attended training prior to undertaking investigations. It is advantageous for all incident investigators, whether SIs or not, have had some form of investigation training.

6.1 A systems approach and human factors

The basis of a systems approach to incident investigation and analysis is that while adjusting individual performance may appear to resolve an incident, it does not ensure the type of incident won’t happen again; human errors are common and inevitably repeated. If the focus is on the process and the system factors that enabled the incident to occur, the process can be adjusted to minimise human error, resulting in fewer opportunities to occur again.

When an incident occurs, too often, the focus is on staff performance and is hoped to be corrected with warnings, retraining and further sanctions. This response is unproductive in improving the quality and safety of care.

A systems approach’s main principle is that most types of human error cannot be eliminated, so the system must be altered for safety and reliability. This does not eliminate the need for highly trained individuals with competency standards.

6.2 Types of behaviour

6.2.1 Normal error (human error) (support)

Inadvertent action such as a slip, lapse, or mistake.

Manage by changing:

• processes
• procedures
• design
• environment

6.2.2 At-risk behaviour (coach)

Individual is not educated about potential risk and sees no value in established policies to prevent it.

Manage by:

• removing incentives for at-risk behaviours
• creating incentives for positive behaviours
• educate about potential risks
• redesign of system factors

6.2.3 Reckless behaviour (sanction)

Conscious and deliberate violations of procedures and policies.

Manage through:

• remedial action
• punitive action

6.2.3 Root cause analysis

The root cause analysis methodology although is an old approach is more common currently in the NHS. It is a structured team-based approach, which when used correctly, can benefit all stakeholders involved in providing care and treatment to patients. The objective of this approach is to develop learning and open culture where staff are proactive and committed to continuously improving safety.

• Gather and organise information.
• Establish good clinical practice.
• Analyse and define the problem
• Understand and locate the root cause of the problem.
• Put corrective action into place.
• Monitor progress.
• Learn and share experiences.

The key tools (see RCA Tools available on the Intranet) introduced are:

• the time and tabular timeline
• the 5 why’s
• the incident decision tree
• change analysis
• the nominal group technique and ranking
• the fishbone
• the learning and development department delivers the root cause analysis training and will provide bespoke training to groups and individuals on request

7 Monitoring arrangements

7.1 SI Monthly report

• How: Report.
• Who by: Head of patient safety or patient safety specialist
• Reported to: Care group quality governance meetings, serious incidents group.
• Frequency: Monthly.

7.2 Performance management action plans

• How: Report.
• Who by: Head of patient safety or patient safety specialist
• Reported to: Care group quality governance meetings, serious incidents group.
• Frequency: Monthly.

7.3 Patient safety dashboard

• How: Report.
• Who by: Head of patient safety.
• Reported to: Care group quality governance meetings, quality committee, NHS Doncaster, NHS Rotherham, NHS North Lincolnshire.
• Frequency: Monthly.

8 Equality impact assessment screening

To download the equality impact assessment for this policy, please follow this link: Equality impact assessment.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

Consequently, the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity, and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individual’s capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005) . For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the rights of individual are protected, and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act (2005) (section 1).

9 Links to any other associated documents

• Being open policy (incorporating the duty of candour)
• Claims handling policy (management of clinical negligence claims, employer or public liability claims, property expense scheme claims)
• Clinical risk assessment and management policy
• Listening and responding to concerns and complaints policy (formally complaints handling policy)
• MCA deprivation of liberty (DoL) policy
• Disciplinary policy
• Freedom to speak up policy: raising concerns (whistleblowing) policy
• Health and safety policy
• Healthy workplaces staff support and stress at work policy
• MCA Mental Capacity Act 2005 policy
• Safe and secure handling of medicines manual
• Safeguarding adults policy
• Safeguarding children policy

10 References

• Care Quality Commission, (2015). Guidance for providers on meeting the regulations.
• Dangerous Drugs, England, and Scotland, Instrument No. 3148 The Controlled Drugs (Supervision of Management and Use) Regulations 2006.
• Department of Health, (2007). Safer Management of Controlled Drugs, A Guide to Good Practice in Secondary Care.
• Department of Health, (2015). Checklist Guidance for Reporting, Managing and Investigating Information Governance and Cyber Security Serious Incidents Requiring Investigation. V 5.1.
• NHS Yorkshire and the Humber Commissioning of Independent Investigations Policy Statement
• NHS Yorkshire and the Humber learning the lessons from ‘extreme’ SIs: How do we ensure that it couldn’t happen here…? December 2009.
• NHS Improvement, (2015). Serious Incident Framework March 2015.
• NHS Improvement, (2018). Never Events Policy and Framework.

11 Appendices

11.1 Appendix A A mortality reporting and review process

11.1.1 For all deaths of under 18 years

1. Clinical services receive notification of death for a patient where we are the primary care provider.
2. IR1 form completed, and manager informed.
3. Follow safeguarding children process detailed within the safeguarding children policy.

11.1.2 For expected deaths due to natural causes (EN1 and EN2)

1. Clinical services receive notification of death for a patient where we are the primary care provider.
2. IR1 form completed, and manager informed.
3. Mortality IR1 to be inputted and reviewed by at least band 7 manager to ensure death was expected, and that the care provided by the trust was suitable and sufficient.
4. Issues identified?
   • no, manager to complete IR1, documenting the review, IR1 closed, end process.
5. Yes, death reported to the coroner, other than industrial disease?
   • yes, if notification form has not already been done, the coroner must be informed of the death if patient is:
     • patient suicide
     • suicide of a person within 6 months of discharge from service
     • subject to detention under MHA 1983 including community treatment order (CTO)
     • subject to deprivation of liberty safeguards
     • under 18 years
     • deceased due to occupational injury or disease
   • team manager logs an incident on the risk system and escalates to the trust Patient Safety team within 24 hours, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.
6. No, assessed that full SI investigation recommended?
   • yes, team manager logs an incident on the risk system and escalates to the trust Patient Safety team within 24 hours, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.
7. No, SJR completed by trained clinician and reported back to the mortality operational group?
   • yes, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.
   • no, IR1 closed, end process.

11.1.3 For unexpected deaths, but due to natural causes (UN1 and UN2) and expected deaths due to unnatural causes (EU)

1. Clinical services receive notification of death for a patient where we are the primary care provider.
2. IR1 form completed, and manager informed.
3. Death reported to the coroner, other than industrial disease?
   • yes, If notification form has not already been done, the coroner must be informed of the death if patient is:
     • patient suicide
     • suicide of a person within 6 months of discharge from service
     • subject to detention under MHA 1983 including community treatment order (CTO)
     • subject to deprivation of liberty safeguards
     • under 18 years
     • deceased due to occupational injury or disease
   • team manager logs an incident on the risk system and escalates to the trust Patient Safety team within 24 hours, full SI investigation to be undertaken equals follow SI process and time frames, IR1 Closed, end process.
4. No, assessed that full SI investigation recommended?
   • yes, team manager logs an incident on the risk system and escalates to the trust Patient Safety team within 24 hours, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.
5. No, SJR completed by trained clinician and reported back to the mortality operational group?
   • yes, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.
   • no, IR1 closed, end process.

11.1.4 For unexpected unnatural deaths (UU) or deaths which meet the criteria of the coroner

1. Clinical services receive notification of death for a patient where we are the primary care provider.
2. IR1 form completed, and manager informed.
3. If notification form has not already been done, the coroner must be informed of the death if patient is:
   • patient suicide
   • suicide of a person within 6 months of discharge from service
   • subject to detention under MHA 1983 including community treatment order (CTO)
   • subject to deprivation of liberty safeguards
   • under 18 years
   • deceased due to occupational injury or disease
4. Team manager logs an incident on the risk system and escalates to the trust Patient Safety team within 24 hours, full SI investigation to be undertaken equals follow SI process and time frames, IR1 closed, end process.

11.2 Appendix B Categories for reporting death on the Ulysses IR1 system

Clinical services receive notification of death for a patient where we are primary care provider.

11.2.1 Expected natural (EN1)

Definition:

• deaths that were expected to occur in an expected time frame. For example, people with terminal illness or in palliative care services

Review guide:

• reviewed by band 7 manager to ascertain that the categorisation is correct, and no care issues are of concern

11.2.2 Expected natural (EN2)

Definition:

• deaths that were expected but were not expected to happen in that timeframe, for example, someone with cancer who dies earlier than anticipated

Review guide:

• reviewed by band 7 manager to ascertain that the categorisation is correct and that there are no suspicious circumstances or care issues

11.2.3 Expected natural (EU)

Definition:

• deaths that are expected but not from the cause expected or timescale, for example, some people on drugs or dependent on alcohol

Review guide:

• reviewed by mortality review group to ascertain that categorisation is correct and whether SI, RCA level or local review is required

11.2.4 Expected natural (UN1)

Definition:

• unexpected deaths which are from a natural cause, for example, a sudden cardiac condition or stroke

Review guide:

• reviewed by mortality review group to ascertain that categorisation is correct and whether SI or RCA level review is required

11.2.5 Expected natural (UN2)

Definition:

• unexpected deaths which are from a natural cause, but which didn’t need to be, for example, some alcohol dependency and where there are care concerns

Review guide:

• reviewed by mortality review group to ascertain that categorisation is correct and whether SI or RCA level review is required

11.2.6 Expected natural (UU)

Definition:

• unexpected deaths which are from unnatural causes, for example, suicide, homicide, abuse, or neglect

Review guide:

• reviewed by SI process

11.2.7 No information available

Definition:

• class as unexpected unnatural (UU) until clarification obtained

Review guide:

• reviewed by mortality review group to ascertain that categorisation is correct and whether SI or RCA level review is required

11.3 Appendix C Definition of never events (2018)

11.3.1 Surgical

• Wrong site surgery.
• Wrong implant or prosthesis.
• Retained foreign object post procedure.

11.3.2 Medication

• Mis selection of a strong potassium solution.
• Administration of medication by the wrong route.
• Overdose of insulin due to abbreviations or incorrect device.
• Overdose of methotrexate for non-cancer treatment.
• Mis-selection of high strength midazolam during conscious sedation.

11.3.3 Mental health

• Failure to install functional collapsible shower or curtain rails.

11.3.4 General

• Falls from poorly restricted windows.
• Chest or neck entrapment in bed rails.
• Transfusion or transplantation of ABO-incompatible blood components or organs
• Misplaced naso-gastric tubes or oro-gastric tubes.
• Scalding of patients.
• Unintentional connection of a patient requiring oxygen to an air flowmeter.
• Undetected oesophageal intubation (temporarily suspended as a Never Event).

11.4 Appendix D Quick reference flow chart for Incident oversight and how the organisation learns from incidents

The IR1 system automatically issues a copy of the IR1 Form to the relevant ward or service or department manager.

In addition the system is programmed to also forward specific categories of incidents to designated leads within the trust for example:

• all incidents rated moderate or above go to the members of the relevant care groups, trust serious incident office, head of patient safety, deputy care group directors for Doncaster and the deputy director of nursing and quality
• falls, trust designated lead
• medication, chief pharmacist
• pressure ulcers, trust lead for pressure ulcer reductions, deputy director of nursing and quality, head of patient safety
• deaths, trust medical director (mortality lead)
• fire, trust fire officer, health and safety and local security manager
• violence and aggression, RRI trainers and local security manager
• infection outbreaks, care groups, Doncaster head of services, and IPC team
• medical devices, medical devices officer
• safeguarding, team representative

1. IR1 generated by staff member who witnessed the incident and severity of harm graded.
2. Near miss, minor (minimum harm), minor (minimum harm), Moderate harm or above.
3. Monthly patient safety, dash boards, dash boards discussed at the care service quality meetings (how outcome or themes and lessons learnt are shared):
   • weekly patient safety messages
   • staff supervision
   • themes and scenarios used to inform staff
   • staff debrief
   • feedback sessions

11.5 Appendix E RIDDOR reporting process for serious non-clinical incidents

Non-clinical accident or incident, ‘An event or circumstance that could have (for example, ‘near miss) or did cause unexpected or unwanted harm, loss or damage to any individual(s) involved including service users (but not related to clinical care), staff, visitors.) or damage to or loss of property or premises for which the trust is responsible.

• Fatalities (non-clinical) related to work activities.
• Specified injuries, including bone fractures (except fingers, thumbs, and toes), limb amputations, serious burns.
• Fatalities (non-clinical) related to work activities.
• Over 7-day injuries,  staff absent from work for more than 7 days (including non-workdays, but excluding the day of the accident)
• Occupational diseases, work-related and medically diagnosed.
• Dangerous occurrences, for example collapse of lifting equipment.

11.5.1 Non-clinical incident occurs, employee

Fatality:

1. notify HSE immediately by telephone (person at incident location)
2. person involved in accident or manager or Patient Safety team to contact Safety team as soon as possible with details of the incident
3. Safety team to report to HSE within 15 days

Specific injury:

1. injured people absent from work for more than 7 days (inclusive of non-working days)
2. person involved in accident or manager or Patient Safety team to contact Safety team as soon as possible with details of the incident
3. Safety team to report to HSE within 15 days

11.5.2 Non-clinical incident occurs, non-employee – visitor, contractor, or patient (not as a result of clinical treatment) injured on trust premises or by work under trust’s control

Fatality:

1. notify HSE immediately by telephone (person at incident location)
2. person involved in accident or manager or Patient Safety team to contact Safety team as soon as possible with details of the incident
3. Safety team to report to HSE within 15 days

Injured person taken from accident site directly to hospital:

1. person involved in accident or manager or Patient Safety team to contact Safety team as soon as possible with details of the incident
2. Safety team to report to HSE within 15 days

11.6 Appendix F Quick reference guide to incident reporting or investigation

11.6.1 Pressure ulcer grade 3 or above

1. IR1 submitted which is rated as moderate harm or above and meets the duty of candour threshold.
2. Root cause analysis (RCA) undertaken by the service or ward manager.
3. RCA presented to the trust pressure ulcer SI panel by the service or ward manager
4. Pressure ulcer panel review the findings of the RCA and determine if the PU was avoidable or unavoidable
   • If unavoidable, case de-logged, end process.
5. If determined avoidable, does it meet threshold for safeguarding alert? and Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred, go to section 11.6.6.

11.6.2 Fall

1. IR1 submitted which is rated as moderate harm or above and meets the duty of candour threshold, end process.

11.6.3 Death due to, suspected suicide, homicide, another cause or unexcepted unknown cause

1. IR1 submitted which is rated as moderate harm or above and meets the duty of candour threshold, end process.

11.6.4 Harm due to to other reasons for example, patient accident, equipment failure or significant self-harm

1. IR1 submitted which is rated as moderate harm or above and meets the duty of candour threshold.
2. Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred, go to section 11.6.6.

11.6.5 Death due to unnatural causes

1. IR1 submitted which is rated as moderate harm or above and meets the duty of candour threshold.
2. Mortality review to be undertaken (refer to the trust learning from deaths policy the right thing to do policy for detailed guidance).
3. Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred, go to section 11.6.6.

11.6.6 Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred

1. Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred.
2. Review to be undertaken within 21 days for near miss to minor harm incidents 28 days for moderate incidents and 60 days for severe and above of the incident occurring.

11.6.6.1 No service delivery or key care problem identified from the reviews

1. Structured review to be signed off by the care group team manger or modern matron, then care group director.
2. Signed off structured review to be forwarded to the trust Patient Safety team.
   • Investigation team agree with action, case closed, end process.
3. Investigation team disagrees with findings or find out more information is needed.
4. Discuss with care group director and agree.
5. Full SI investigation to be undertaken, end process.

11.6.6.1 Some low-level individual issue identified that can be addressed through reflective practice

1. If issues found that case cannot be resolved within the team or there is wider organisational learning from the incident, a full SI investigation to be undertaken, end process.
2. If not structured review to be signed off by the Care Group team manger or modern matron, then care group director.
3. Signed off structured review to be forwarded to the trust Patient Safety team.
   • Investigation team agree with action, case closed, end process.
4. Investigation team disagrees with findings or find out more information is needed.
5. Discuss with care group director and agree.
6. Full SI investigation to be undertaken, end process.

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Document control

• Version: 18.1.
• Unique reference number: 325.
• Ratified by: Clinical policies review and approval group.
• Date ratified: 29 January 2024.
• Name of originator or author: Head of patient safety or patient safety specialist.
• Name of responsible individual: Executive director of nursing and allied health professions.
• Date Issued: 1 February 2024.
• Review date: 25 August 2025.
• Target audience: All staff.

Page last reviewed: April 15, 2024
Next review due: April 15, 2025

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