Management of investigations and serious incidents policy

The purpose of this policy is to ensure that risks associated with serious incidents are identified and managed in accordance with best practice and in line with the expectations of the NHS Resolution, the Health and Safety Executive, the Care Quality Commission, NHS England and NHS Improvement, Clinical Commissioning Groups and the public.

Publication date:
01 September 2019
Date range:
September 2019 - September 2022

6. Investigation and root cause analysis

Serious incident and reporting severe harm and above flowchart

 

Alternatively you can view the text version of the flow chart below. 

Text version of the serious incident and reporting severe harm and above flowchart

  • 1

    Immediately inform manager/shift lead/service manager/on call manager.
    • 1.1

      Assess medical needs of people involved. 
  • 2

    Before end of day qualified member completes incident report form (online Datix).
    • Inform the service user / relatives – Tell them that the incident will be reviewed and actions taken as appropriate.
    • Review risk assessment/care plan/observation levels/leave etc
    • Consider adult/child protection alert and/or police involvement
    • Urgent learning shared
    • Consider Duty of Candour for incidents where moderate, severe, death or prolonged psychological harm has occurred or where the degree of harm is not yet clear but may fall into the above categories in future, in line with the requirements of Regulation 20, and follow the process.
    • Where appropriate action 2.1. and or 2.2
      • 2.1

        Takes urgent action as relevant
      • 2.2

        • Where staff member injured or traumatised, manager considers referral to Occupational Health
        • Informs Ministry of Justice (Forensic services)
        • Head of Patient Safety or Patient Safety and Risk Manager communicates with other external agencies/media (e.g. police)
  • 3

    WITHIN 48 HOURS Manager completes MANAGEMENT REPORT (on Datix) and DRAFTS ACTION PLAN
    This must include:
    • To share and reflect upon current practice (actions before, during and after the incident)
    • To highlight ways of improving practice (learning)
    • To support staff and service users and encourage the therapeutic relationship between staff, service users and their carers
    • To ensure best practice is followed
    • To provide an opportunity to highlight issues with trust systems and trust/local policies, procedures and protocols.
    • This report will be reviewed by the care group, Head of Patient Safety or deputy and provided to the Director of Nursing and Quality and to be sent to the CQC as required.
    • Assurance that Duty of Candour has been commenced if the incident meets this criteria.
    • Where disturbed/violent behaviour – Clinical team carry out a Clinical Review meeting using NICE format (within 72 hours)
      • 3.1

        • Considers RIDDOR
        • Where patient/staff is potentially traumatised, Clinical Team OFFER initial support. Manager/psychology to monitor wellbeing of staff/service user and offer access to further
          support / counselling if signs of trauma still evident in long term
        • consider the use of the Just Culture Guide if there is consideration of a managerial
          investigation (see section 7).
  • 4

    Trust Wide Serious Incident and Mortality panel reviews the 48 hour Management Report at the next meeting, using the SI and Mortality Decision making flow chart to determine if a reportable incident has occurred. In the event that a Serious Incident is declared the Serious Incident Administrator will report this by entering on the STEIS system.
  • 5

    WITHIN TWO WORKING DAYS OF THE SI AND MORTALITY DECISION:
    • 48 hour report to be updated, amended appropriately and sent to the Compliance and
      Assurance Manager.

Those requiring notification to the CQC are unexpected deaths including suicide and homicide (for statutory requirements any death of any patient detained or liable to be detained whilst in our care).

  • 6

    WITHIN 45 WORKING DAYS the investigation team completes a LEARNING REVIEW INVESTIGATION (RCA) to highlight root cause(s), contributory factors, learning and recommendations. This should involve all staff involved in the incident.
  • 7

    Learning Review is approved by Care Group Head of Service, Head of Patient Safety and Executive Director of Nursing and Quality and submitted to the CCG within 60 working days of reporting on STEIS.
  • 8

    When the action plan completed SI closed by Care Group Patient Safety meeting/Chair.

6.1 Investigation process

  • 6.1.1

    Appointment of an investigating lead/team
  • 6.1.2

    The RCA investigation must be undertaken by more than one person to enable greater objectivity.
  • 6.1.3

    One of the investigators must be 2 day RCA trained.
  • 6.1.4

    The investigating team will consist of a lead investigator trained in root cause analysis, supported by other staff. The appointment of the investigating lead will be made by the Care Group Patient Safety Lead.
  • 6.1.5

    Where the SI is a homicide, inpatient suicide or likely to attract a lot of public interest, it may be necessary to appoint an external investigator to support the internal investigating team. This will be approved by the Executive Director of Nursing and Governance and the Chief Executive. The communications team should be informed.
  • 6.1.6

    The team will receive the full support and authorisation of the KMPT Board.
  • 6.1.7

    Where the Serious Incident is a homicide or child death, board level panel reviews will be conducted and will be chaired by a non- executive director.

6.2

The first step in conducting an RCA is to commence a tabular timeline of events based on the scope and Terms of Reference provided by the Patient Safety Lead. Investigators are asked to identify any good practice, problems in care, acts or omissions within the timeline. It is important that timelines are not made up of just healthcare records. Evidence should be gleaned from multiple sources. This process will help to identify who may need to be invited to meet with investigators as part of the investigation.

6.3

Identification of people to be included in the RCA meeting or to have a meeting with the investigator

  • 6.3.1

    Information must be collected from all available sources, both in terms of the specific events (which should be added to the timeline) and those underlying contributing factors. During this scoping exercise, consideration will be given to those staff, visitors, patients that the team may wish to meet with during the investigation. This will vary on a case by case basis.
Evidence to be considered when undertaking a root cause analysis investigation
Identified areas of evidence to consider (5Ps) Involvement
People

Those staff, patients, visitors or anyone else who was involved in the Serious Incident.

Anyone who witnessed the event but was not directly involved.

The wider team(s).

Organisation leads.

It can be helpful to ask people to make notes of the event to refresh themselves when the RCA meeting or meeting with people occurs as part of the investigation

Place(s)

Review of the area where the incident occurred. It can be helpful to visit the area at the same time on the same day of the week that an incident occurred. This can identify areas of concern.

Health and Safety Leads.

Staff involved.

NHS Accredited Security Management Specialist (ASMS).

Parts (equipment)

Any equipment that has been involved and has been considered to have participated in the Serious Incident should be retained and be checked.

Medical Devices Manager – Medical devices

Hoists – Moving and Handling Trainer

Resuscitation Officer

Health and Safety Leads

Paper

Medical records will often be a starting point to commencing a timeline in a clinical investigation, however there will be other areas that need to be reviewed:

EME records and other maintenance records

Duty rotas

Diaries

Handover records

Policies

Mental Health Act

External guidance such as NICE guidance

Staff involved or other experts

Records Manager

Information Rights Manager

Caldicott Guardian

Paradigm of working

The widely held beliefs about the normal working processes, team relationships, and adequacy of leadership in the work place (how the team works).

Staff within the team

Consultation group

Experts

Executive Director of Nursing and Quality

Deputy Director of Nursing

Executive Medical Director

Clinical Leads

Senior Practitioners

Heads of Service

Another similar team

External Experts/other Trusts

  This list is not exhaustive and each investigation has to be
reviewed on a case to case basis
  • 6.3.2

    It may be useful to advise staff/patients/families/carers or visitors to keep their own record of the incident and events leading up to it. This is for their own personal use.

    Very occasionally staff will be asked to write a statement if there will be a court case, however this would normally not be required or investigations. For assistance with writing statements please contact the Trust Legal Services Department, Human Resources Managers or Trade Union Officer.
  • 6.3.3

    It is recognised that the Trust may have to involve other organisations in the investigation or that other organisations may take the lead on the investigation process such as a Police investigation. However since the introduction of the

    Memorandum of Understanding this enables Trusts, Police, NHS organisations and the Health & Safety Executive to meet post incidence and identify roles, processes and information sharing.

6.4 RCA meetings

  • 6.4.1

    Ideally the investigation team and staff involved will meet to review the timeline and analyse what has occurred. This will lead to the team involved to determine SMART actions to prevent further incidents occurring.

6.5 Conducting meetings with staff involved

  • 6.5.1

    At all stages sensitivity and tact will be practised with appropriate support available
    for anyone providing information into the investigation process
  • 6.5.2

    All those identified for to meet with the investigators will be contacted by the investigation team who will explain the process and purpose of the investigation, to include
    • a) To find out what happened?
    • b) To identify areas of good practice
    • c) Areas where systems did not work
    • d) Implement safety improvements
  • 6.5.3

    Following the meeting, the investigator will share notes with the interviewee via email for an agreement of accuracy. This ensures there is a record.
  • 6.5.4

    All staff involved must have access to confidential support and counselling during a potentially stressful period and that they can bring a staff side representative or workplace colleague with them at any interview.
  • 6.5.5

    Patients/families/carers may wish to have a friend or relative with them or wish to bring an advocate. Patients/families/carers and visitors to sites will be offered further support and signposted to counselling.
  • 6.5.6

    All investigations to be conducted in a manner:
    • a) That is demonstrably supportive and with listening;
    • b) In a blame free atmosphere;
    • c) For learning and improving
    • d) And those involved will be given information on progress as appropriate.

6.6

On occasions, at end stage during an investigation, it may be deemed that a managerial investigation may also be required. When this occurs the Just Culture Guide must be used. See section 7.

6.7 Support for the investigating team

  • 6.7.1

    Patient Safety Lead and the Head of Patient Safety are to be available to anyone undertaking an investigation who requires support or the opportunity to discuss process and progress or who just wants the opportunity to reflect on the investigation so far.

6.8 Timescales for feedback to interested parties

  • 6.8.1

    Time scales: it is important investigations are carried out expeditiously as delay can lead to a reduction in reliability of the memories of those concerned, anxiety on the part of those involved in the investigation, including patients, families and staff, and dissatisfaction for those who have raised the matter for investigation. The timescale for completion of the investigation is 60 working days, although this may be extended where there are exceptional circumstances and investigators should discuss this in good time with the Patient Safety Lead to allow for an extension request to be made to the CCG. Feedback will be the responsibility of the Lead Investigator. Patients and families should be advised of extensions.

6.9 Involvement of any external agencies

  • 6.9.1

    Other agencies or organisations may become involved depending on the nature of the SI e.g.
    • a) Police Force,
      b) Coroners Officer,
      c) Local Authority,
      d) Clinical Commissioning Groups,
      e) Primary Care Trusts,
      f) Health & Safety Executive,
      g) NHS England,
      h) Care Quality Commission,
      i) Social Services and
      j) Other health care trusts
      k) (This list is not exhaustive).

6.10 Completing the RCA report

  • 6.10.1

    The report of the investigation should be prepared using the template that will be provided by the Patient Safety Lead and will include the development of a SMART action plan:

Specific

Say exactly what you mean.

Measurable

It can be evidenced that the action is completed.

Achievable

They can be completed in a reasonable time frame.

Realistic

Actions that can be achieved.

Time-related

They have realistic deadlines

  • 6.10.2

    All actions will be inputted on to the actions module on Datix by the care group Patient Safety Team.
  • 6.10.3

    Each action has an individual “owner” who is responsible for the monitoring and completion (including evidence) of the action.
  • 6.10.4

    The care group patient safety team meeting will review the evidence to ensure it is robust before closing the action.
  • 6.10.5

    The report will be quality checked and returned to investigators if necessary for amendments. Once complete the report will be scrutinised by the Head of Service, Head of Patient Safety and the Executive Director of Nursing and Quality. The final report must be submitted to the relevant Clinical Commissioning Group within 60 working days. There are some circumstances in which the deadline can be extended, for example to allow for Police investigations. The report must be submitted to the Head of Patient Safety and Risk Manager within 45 working days from the date the incident was declared.
  • 6.10.6

    A copy of the report is shared with the patient, family and/or carers, the team and others as relevant in a manner agreed with them.