5 Key issues, Investigation, Root Cause Analysis and Support for All Involved (Staff, Patients and Families)

5.1 Investigations, whether they be through root cause analysis, or trend and themed analysis, are completed to ensure that repeated incidents do not occur, allows patients and families to understand why the incident happened, and also provide assurance of good practice.

5.2 In most cases a serious incident does not result from one single event, but is more likely to have involved cumulative triggers which, in isolation may have no effect, but when they occur in an event chain can be serious or even catastrophic. Almost all investigations will determine systems errors that have led to the incident occurring, even when it appears to have been due to an individual making an error.

5.3 When investigating a serious incident, it is important to concentrate on the facts, with a retrospective review of events to establish the underlying causes. Analysis will then identify areas for change, looking at long-term solutions, improving standards and improving patient safety and to minimise reoccurrence in the future or to reduce the level of harm.

5.4 The process for root cause analysis investigations is documented in appendix 4.

5.5 Determining a Serious Incident and who will investigate (including independent investigations)
5.5.1 Decision making as to whether to STEIS report will usually be made by the Serious Incident and Mortality Panel. In line with appendix 4 and the NHSE Serious Incident Framework 2015. On occasions, the Panel may seek Executive opinion if a decision cannot be made. Additionally, a structured judgement review or care group investigation may take place to seek further assurance, or when a case does not meet STEIS criteria.
5.5.2 Occasionally, an independent investigation may be considered where the integrity of the organisation is likely to be challenged or where it would be difficult for an organisation to conduct an objective investigation. In these situations, the investigation team must all be independent of the Trust. Should this be required, an Executive decision will be made.
5.5.3 The Serious Incident and Mortality Panel will determine initial terms of reference for the investigation.

5.6 Investigating
5.6.1 The key features of a good investigation are:
• Clear terms of reference (these may be added to during the course of the investigation by the investigator, care group or others) and parameters (scope);
• Involvement of patients, their families and carers, and witnesses, using a collaborative approach as far as possible and in line with Duty of Candour. The Trust believes that patients and their families/carers are a critical part in learning from serious incidents. The level of patient/family/carer involvement depends on the nature of the incident, the patient and the patient’s consent for their family to be involved. Access to language and sign interpreters will be provided, as required. It is expected that patients and/or families/carers will be invited to include terms of reference to the investigation;
• Involvement of staff involved including leaders of those involved and beyond, and openness and transparency of those who have been involved in the incident, and objectivity by investigators and peer review of investigations;
• Involvement of experts in the investigation;
• A timely and responsive investigation, to ensure that no other patients are involved in similar incidents;
• A proportionate investigation;
• A thorough identification and analysis of events with clear rationale, with a system thinking approach;
• A clear and concise report;
• SMART actions put in place to prevent repeat incidents, including how the actions can be measured. These are to be developed by a facilitated action plan meeting, if required, and include appropriate staff as determined by the care group in line with appendix 8.

5.6.2 It is important to also note that learning occurs equally from good practice as well as practice that requires improvement.
5.6.3 Summaries of learning to share safety lessons and best practice will be publicised in Trust Wide and local learning bulletins.
5.6.4 If the need to communicate to all staff is urgent this will be done through the Communications Team.
5.6.5 The Serious Incident and Mortality Panel or IMR or the investigator during the course of the investigation will identify when there is a need to involve external agencies following a Serious Incident. This may include police, other provider organisations or organisations involved in supporting the patient, and commissioners of services. The investigation will be escalated to experts within the organisation for learning and any external reporting required. It is usual that if a police investigation is occurring that the lead investigator will liaise with police to check when KMPT can carry out their investigation.
5.6.6 It is recognised learning can take place in many ways other than root cause analysis, but can be included in root cause analysis investigations. Learning from patient safety should be embedded across the organisation.
5.6.7 Researched approaches and methods known to be effective for learning from patient safety are shown below and should also be embraced by all members of the organisation.

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• Psychological safety - An environment where staff feel safe to raise concerns, have the freedom to speak up, with an expectation that staff can openly discuss errors and be free from punishment or blame for the disclosure.

• Staff involvement - An environment where staff involvement is prioritised and staff have time to talk about patient safety in order to learn from patient safety incidents.

• Storytelling - An environment where staff are encouraged and are able to share stories relating to errors or mistakes in order for other individuals or teams to learn.

5.6.8 There are times when a themed analysis approach may be made in regards to areas of concern which may be a risk to patient safety. This will also follow the STEIS reporting process and be investigated by the CIT if the risk is great. This must be determined by the Serious Incident and Mortality Panel.
5.6.9 The care groups must have methods of ensuring evidence gathering for learning is in place and completed.
5.6.10 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 Serious Incident and Mortality Panel, and also terms of reference as requested by the patient/family/carers. Investigators are asked to identify any good practice, problems in care, and 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. Evidence considerations can be found in the 5P approach in appendix 5. It is noted that there may be times when the investigation may précis another investigation, such as a human resources investigation of safeguarding investigation. In these cases the Précised RCA template should be used as the report (see appendix 12).
5.6.11 The CIT lead investigator will identify people to be included in the RCA meeting or to have meetings with the investigator, with the former being the preferred approach (recognising this is not always possible).
5.6.12 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 for root cause analysis investigations.
5.6.13 It is recognised that other organisations may take the lead on the investigation process and KMPT may contribute.

5.7 RCA meetings
5.7.1 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 help determine potential SMART actions to prevent further incidents occurring.
5.8 Conducting meetings with staff involved
5.8.1 At all stages sensitivity and tact will be practised with appropriate support available for anyone providing information into the investigation process.
5.8.2 All those identified for to meet with the investigators will be contacted by the lead investigator from CIT who will explain the process and purpose of the investigation, to include:
• To find out what happened,
• To identify areas of good practice,
• Areas where systems did not work and
• Commence implementation of safety improvements.

5.8.3 All staff involved must have access to confidential support and counselling if required during a potentially stressful period and that they can bring a staff side representative or workplace colleague with them at any interview.
5.8.4 All investigations to be conducted in a manner:
• That is demonstrably supportive, and with active listening;
• In a just culture atmosphere;
• For learning and improving
• Those involved will be given information on progress as appropriate.

5.8.5 On occasions, at the 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 and appendix 6.

5.9 Conducting meetings with patients/families/carers (see Duty of Candour/Being Open policy)
5.9.1 Patients/families/carers may wish to have a friend or relative with them or wish to bring an advocate. Patients/families/carers and visitors will be offered further support and signposted to counselling if required.
5.9.2 All meetings will be held in a sensitive and supportive manner.
5.9.3 Patients are too unwell for meetings on occasions, and if it has been identified that a representative of the patient can be liaised with, this should also take place.
5.9.4 The patient or representative should be kept informed throughout the investigation.

5.10 Support for the investigating team
5.10.1 The Serious Incident and Complaints Investigation 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.
5.10.2 Each week, investigators will have an opportunity to discuss cases in a peer review meeting. This will be led by the Serious Incident and Complaints Investigation Lead.

5.11 Completing the RCA report
5.11.1 The report of the investigation should be prepared using the appropriate root cause analysis template (see appendices 10, 11 and 12.
5.11.2 It will include the development of a SMART action plan in line with the CIT SOP (see appendix 8):

5.11.3 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 Patient Safety or appointed deputy if unavailable, care group leads and the Chief Nurse or appointed deputy. 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.
5.11.4 A copy of the report is shared with the patient, family and/or carers, the team and others, as relevant, including staff involved in a manner agreed with them, and other organisations.

5.12 Timescales for feedback to interested parties
5.12.1 The timescale for completion of the investigation is usually 60 working days, although this may be extended where there are exceptional circumstances and investigators should discuss this in good time with the Serious Incident and Complaints Investigation 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 during the course of the investigation.
5.12.2 Patients/families and carers should be given feedback from the investigation in line with Duty of Candour i.e. within ten days of completion of the investigation, when signed off by the Chief Nurse or appointed deputy.

5.13 Evidence of action completion
5.13.1 Following completion of the investigation, actions and action plan owners will be added to Datix by the appropriate care group. Care groups will ensure that evidence for closure is appropriate.