Policy for investigating Incidents Claims and complaints Classification: Policy Lead Author: Paul Dodd Head of risk management Additional author(s): N/A Authors Division: Corporate Unique ID: TW1(10) Issue number: 2 Date approved: July 2014 Contents Section Page Who should read this document 2 Key messages 2 Explanation of terms & Definitions 2 Policy/Procedure/Guideline Training 3 Level of Investigation 3 Timescales for investigation 4 Undertaking the investigation 5 Action planning 6 Lesson Learning 7 Documentation 7 Standards 8 References and Supporting Documents 8 Roles and Responsibilities 8 Document control information (Published as separate document) Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Page 1 of 11
Who should read this document? This policy should be read by the nominated lead investigator/s and all involved in the investigation process, to successfully investigate and resolve incidents, complaints and claims Key Messages This policy allows the investigator to identify the direct, contributory and root causes associated with the incident, claim or complaint. The depth of investigation required for incidents, claims and complaints will be determined in the relevant policy for the topic, e.g. the Clostridium Difficile Infection Control Policy, or by the incident grade. The information obtained from the investigation can then be analysed and the common causes and trends highlighted to the organisation via the risk management process (see Risk Management Strategy /Policy.) By analysing such occurrences we can ensure lessons are learnt and practice or Policys are changed appropriately. Explanation of terms & Definitions Immediate Causes / Active Failures Apparent reasons why the event occurred, that need to be analysed to determine underlying Influences. These maybe the incident itself or the subject of the complaint / claim. Root Causes Failures in processes that if eliminated, would prevent, or reduce the likelihood of an adverse Incident from reoccurring. Root Cause Analysis A structured investigation that aims to identify the true cause of a problem, and the actions that are necessary to either eliminate or significantly reduce the risk. The simple approach to root cause analysis is very simple, the investigator asks the question Why? about each significant event in the sequence and keeps asking Why? until its usefulness is exhausted. Page 2 of 11
Immediate & Underlying Causes Patient, Individual,Team Task, Environment Factors Immediate Causes(s) Organisational Management Factors Underlying Causes(s) Root Cause(s) Doing Less Harm It may be necessary for the investigation to undertaken by a team which may need include persons with specialist knowledge e.g. Infection control. Policy/ Guideline/ Protocol Training All staff leading investigations, must have undertaken training in the this Investigation policy. The courses can be accessed be e-mailing learning@srft.nhs.uk Level of Investigation Not all incidents, claims and complaints need to be investigated to the same extent or depth. Having assessed the incident, claim or complaint, the amount of investigation and analysis should be relative to the grade (i.e. green, amber or red) and whether the incident resulted in harm (i.e. adverse event or near miss). All investigations regardless of extent and scope should follow this investigation protocol. Serious Incidents, Claims and Complaints (Major and Catastrophic) The greatest effort should concentrate on events categorised as High or catastrophic (including Serious Untoward Incidents), which should both be the subject of a full root cause analysis. In order to ensure consistency of approach, all such incidents should be presented to the Serious incident Page 3 of 11
action review committee (SIARC). Once accepted as a SIARC Incident then a Root cause analysis must be performed. It is recognised that the efforts involved in investigating and analysing serious near misses may sometimes be less than that required for a severe adverse event. A senior manager will lead the investigation. If this is not a member of the Trusts Corporate Team then the Risk Management, Legal or Complaints Department can be contacted for advice and support. The completed report should be presented to The Serious incident action review committee to facilitate in the sharing of lessons learned across the Trust. Category Amber Incidents, Claims and Complaints (Moderate) Less effort should be expended on category amber incidents than red. An attempt to establish root cause(s) should be made using the principles of this investigation Policy. A local manager supported where necessary by the Divisions Governance Manager and/or any other appropriate people, will undertake the investigation. Category Green Incidents, Claims and Complaints ( Minor and Near Miss) Less effort still should be expended on category green and yellow incidents. These represent low risk situations. The investigation will be undertaken by the local manager with support, if required. NB. 1 - All incidents must be investigated as soon as possible after the event. 2 All incidents declared SIARC (serious incident and actions review committee incident), SUI (serious untoward incident) and RIDDOR (Reporting of injuries, diseases and dangerous occurrence regulation incidents) must be the subject of a full root cause analysis. Timescales for investigation Classification of incident Timescale Level of investigation Serious Untoward Incident 40 working days Root Cause Analysis SIARC Incident 40 working days Root Cause Analysis RIDDOR Incident 40 working days Root Cause Analysis Amber rated incidents (excluding the above) 14 days Thorough investigation identifying potential root causes Green Rated Incidents 14 days Local Investigation Page 4 of 11
Undertaking the investigation The investigation should concentrate on factual information from all available sources. It is essential that the investigator should not pre judge events and issues under investigation. The Process The process for undertaking the investigation should be considered as a three-step process 1. Data collection 2. Identifying failures 3. Analysis/Root cause analysis Step 1 Data Collection Data collection could be obtained from a variety of sources, which may include incident reports, statements, direct observation, notes, records, site inspections, or interviews. The information collected should include background information leading up to the incident/event including:- Who was involved? What happened? Where exactly? When? Step 2 Identifying Failures To identify all failures a chronology of events and a process mapping exercise should be undertaken. A chronology involves the mapping of events to demonstrate the order and time(s) they occurred. This should be what actually happened based on the information gathered in Step 1. This may be performed on the investigation template, found on the following link http://intranet/policies-resources/trust-policy-documents/trust-widegeneral/forms/investigationtemplate/ A process mapping exercise should then be undertaken. This should follow the events which should have taken place. This can often be taken from policy, procedure and standard operating procedure documents where they exist. However, should these not exist for the process being investigated then what would have been expected to happen based on professional judgement, opinion or practice, should be used. This may also be completed on the investigation template http://intranet/policies-resources/trust-policy-documents/trust-widegeneral/forms/investigationtemplate/ Page 5 of 11
Compare the conditions and sequence of events against standards, polices and guidelines or what would have been accepted practice at the time the event took place, i.e. using the chronology and process map, identify points of deviation. Where there are differences between the chronology and the process map, then analysis should be undertaken for each difference. Step 3 Analysis/Root Cause Analysis Root cause analysis merely enables one to diagnose, it can simply be asking the question Why? For those deviations from expected practice which were identified in Step 2, the question Why? should be asked. This should be repeated until a root cause or system failing is identified. The following is an example of this Q1 Why, did the member of staff make an error? A1 Because he/she did not pay sufficient attention to the important part of the problem. Q2 A2 Q3 A3 Q4 A4 Q5 A5 Why, didn t he/she pay sufficient attention? Because he was stressed Why, was he/she stressed? Because he/she was caring for two acutely ill patients at the same time and he/she was rather inexperienced. Why, did he/she have to do that? Couldn t he/she contact someone for help? Was he/she too inexperienced to be assigned to this work task? Well, the senior members of staff don t like to be disturbed at night, and yes, he/she was maybe too inexperienced for this kind of patient care assignment. Why, were protocols not followed relating to regulating the necessary level of training and experience that members of staff must have before they are assigned to a particular care task? There aren t any. Remember to examine the:- Human factors e.g. mistakes, peer pressures, team or individual Physical factors e.g. Physical conditions Organisation factors e.g. System failures Environmental Factors e.g. Heat, light, noise, restricted space It is important to remember that there maybe multiple causes, variances between process map and chronology, and each one will need a root cause analysis. Action Planning Once the root causes of and incident, complaint or claim have been established, and action plan must be developed to address all the root causes identified. The action plan template. This can be found on the following link. Page 6 of 11
Serious Untoward Incidents (SUI s): Once an action plan has been agreed, a date for the presentation of the action plan to and Executive assurance committee will also be determined. This, dependent on the incident and planned preventative measures, may be on completion of the actions Serious Incident Action Review Committee Incidents (SIARC): Once and action plan has been approved by the SIARC, the date of approval will be recorded on the Datix system, and a date agreed, based on the timescales for actions and level of risk, for the action plan to be represented to the committee. Lessons Learned The lead for the investigation must ensure that the report and action plan is presented to relevant personnel and/or committees to ensure that the lessons which may be learned from the investigation are shared appropriately. This may include external stakeholders. The circulation for the investigation report should be documented in the section at the end of the report template, found via the following link - http://intranet/policies-resources/trust-policydocuments/trust-wide-general/forms/investigationtemplate/ Documentation The flowing link leads to a template document for Investigation. It follows the procedure found in the policy. When a Root Cause Analysis investigation is performed, then this template should be used. The link to the template is - http://intranet/policies-resources/trust-policy-documents/trust-widegeneral/forms/investigationtemplate/ All Investigation reports where actions are identified as being required must be accompanied by an action plan. The template for this is found via the following link - http://intranet/policies-resources/trust-policy-documents/trustwide-general/forms/actionplantemplate/ The committee/manager may require frequent progress reports on an action plan. This will be determined by the committee/manager, based on the; timescale covered by the action plan, complexity of actions and/or the potential severity of the incident claim or complaint which has been investigated. All documentation associated with the investigation, e.g. statements, time line where a separate one is completed, and the root cause analysis template, must be attached to the Incident report entry on the Datix System. Where investigation reports require amendments, version numbers should be entered on the front of the report. Subject specific Investigation documentation will be made available as it is developed, via the Trust s intranet. Page 7 of 11
Standards All Serious Untoward Incidents (sui S) are reported on the Strategic Executive Information System (StEIS). This is monitored by the Clinical Commissioning Group (CCG). The standards of performance against which the Trust is monitored are: Initial Logging of an SUI 2 working days Root Cause Analysis submission 45 Working days References and Supporting Documents National Patient Safety Agency - Root Cause Analysis (RCA) toolkit (now managed by NHS England) NHS Institute for Innovation and Improvement Root Cause Analysis Using Five Why s Health and Safety Executive - Investigating accidents and incidents Roles and responsibilities Executive Director of Nursing and Midwifery The Executive Nurse Director is the Executive Director with the overall responsibility for Risk Management and will, so far as is reasonably practical, ensure that: This Policy is implemented through out the Trust Relevant information from Investigation Reports is reported to the Trust Board Assistant Director of Patient Safety/Governance and Quality Improvement Will, so far as is reasonably practical: Ensure the implementation of this policy Ensure the policy is followed in all areas of the Trust Advise and support managers and staff in the investigation process for claims and inquests Undertake, lead or co-ordinate investigations into claims, inquests and Serious untoward incidents Advise and support managers in the production of reports and action plans resulting from investigations Ensure reports and action plans are produced for those investigations he/she leads, undertakes or co-ordinates Page 8 of 11
Ensure appropriate communication and liaison with relevant managers and staff across the Trust. Maintain effective communications with the Trusts Head of Risk Management and Complaints Manager with regards to investigations and their outcomes. Ensure good communication channels exist, via the Trusts Governance Structure to support learning from investigations. Head of Risk Management Will, so far as is reasonably practical: Ensure the implementation of this policy Ensure appropriate training is provided for relevant managers and staff Advise and support managers and staff in the investigation process for incidents Undertake, lead or co-ordinate investigations into incidents Advise and support managers in the production of reports and action plans resulting from investigations Ensure reports and action plans are produced for those investigations he/she leads, undertakes or co-ordinates Ensure appropriate communication and liaison systems are in place, with relevant managers and staff across the Trust, including Staff side safety representatives. Maintain effective communications with the Trusts Complaints Manager, and Assistant Director of Patient Safety with regards to investigations and their outcomes. Ensure good communication channels exist, via the Trusts Governance Structure to support learning from investigations. Complaints Manager Will, so far as is reasonably practical: Advise and support managers and staff in the investigation process for complaints and claims Undertake, lead or co-ordinate investigations into complaints Advise and support managers in the production of reports and action plans resulting from investigations Ensure reports and action plans are produced for those investigations he/she leads, undertakes or co-ordinates Ensure appropriate communication and liaison with relevant managers and staff across the Trust. Maintain effective communications with the Trusts Head of Risk Management with regards to investigations and their outcomes. Page 9 of 11
Ensure good communication channels exist, via the Trusts Governance Structure to support learning from investigations. Senior Managers, Divisional Managing Directors, Divisional Directors of Nursing and Clinical Directors/chairs Will, so far as is reasonably practical: Ensure that this Policy is implemented within their area of responsibility Ensure sufficient resources are applied to this Policy (For example, human and time resources). Ensure that investigation reports and subsequent action plans are presented to Divisional Boards, or equivalent meetings. Ensure that action plans resulting from investigations are implemented and monitored. Ensure appropriate and timely communications are undertaken with the Risk Management, Complaints, and legal Departments Ensure appropriate staff and/or Managers in their area of responsibility are trained in Root Cause Analysis Ensure agreed action plans are completed within their area of responsibility Divisional Governance Managers Will, for their areas of responsibility, so far as is reasonably practical: Implement this Policy in their area of responsibility Lead/Co-ordinate or undertake investigations Advise and support managers and staff Ensure reports and action plans developed from investigations are communicated effectively within their division, at appropriate Trust forums and to relevant stakeholders Ensure that learning and changes to practice from investigations are communicated to all appropriate staff ( appropriate staff will depend upon the individual investigation) Ensure monitoring of action plans and their implementation Ensure appropriate and timely communications are undertaken with the Risk Management, Complaints and legal Departments Ensure appropriate staff and/or Managers in their area of responsibility are trained in Root Cause Analysis Ensure agreed action plans are completed within their area of responsibility Ward/Departmental Managers Will, so far as is reasonably practical, for their area of responsibility: Implement this Policy Page 10 of 11
Assist in, and undertake investigations Support their staff in the Investigation Policy Develop and implement action plans arising from investigations Monitor the implementation and effectiveness of these action plans Ensure appropriate staff and/or Managers in their area of responsibility are trained in Root Cause Analysis Ensure agreed action plans are completed within their area of responsibility Consider involvement of the Staff side safety representatives in the investigation process Ensure appropriate and adequate communication of the investigation is undertaken with the Staff side safety representatives when incidents involving staff, e.g. RIDDOR investigations, are undertaken Page 11 of 11