INCIDENT REPORTING POLICY: INCLUDING THE MANAGEMENT OF TRAFFORD CCG AND PROVIDER SERIOUS INCIDENTS (SIs)

Transcription

1 INCIDENT REPORTING POLICY: INCLUDING THE MANAGEMENT OF TRAFFORD CCG AND PROVIDER SERIOUS INCIDENTS (SIs) Version 2.0 Page 1 of 37 AUGUST 2015 (RM)

2 POLICY DOCUMENT VERSION CONTROL CERTIFICATE TITLE Title: Incident Reporting Policy (Including The Management of Trafford CCG and Provider Serious Incidents) Version: 2.0 SUPERSEDES Title: General Policies and Procedures: Incident Reporting Policy (Including The Management of Serious Incidents). Version: 1.0 Description of Amendments: Updated to reflect the new national guidance ORIGINATOR Originator/Author: Helen Rogers, Senior Clinical Quality Manager Karl Taylor, Customer Care & Experience Manager Designation: Customer Care and Experience Team Lead Director: Paul Hulme, Associate Director of Corporate Services & Organisational Development EXECUTIVE APPROVAL Approved by: Quality and Performance Committee Date Approved: 11 th August 2015 EQUALITY ANALYSIS Date Completed: July 2015 COR008 Incident reporting policy (inc SU CIRCULATION Issue Date: September 2015 (signed off by the Governance Team) Circulated by: Corporate Services Team Issued To: (as per Circulation List) REVIEW Review Date: August 2017 Responsibility of: Customer Care & Experience Manager, and Quality Team Version 2.0 Page 2 of 37 AUGUST 2015 (RM)

3 CIRCULATION LIST Prior to Approval, this Policy Document was circulated to the following for consultation: Associate Director Corporate Services and OD CCG Quality and Performance Committee Following Approval this Policy Document will be circulated to: Notification to CCG staff via Staff News Bulletin Executive Directors CCG Intranet VERSION CONTROL Version Date Description of Change Author V1.0 October 2014 New Policy - Approved by Quality and Performance Committee V2.0 August 2015 Updated to reflect the new national guidance Customer Care & Experience Manager Senior Clinical Quality Manager, and Customer Care & Experience Manager Version 2.0 Page 3 of 37 AUGUST 2015 (RM)

4 CONTENTS Section 1.0 Introduction 6 Page Policy Aims Integrating Risk Management Activities A Duty of Candour and a Commitment to an Open and Fair Culture Definitions Untoward Incident Serious Incidents (SIs) Near Miss Organisational Responsibilities The CCG Governing Body and the Chief Clinical Officer The Quality and Performance Committee The Clinical Director for Quality and Performance The Quality Team The Caldicott Guardian The Head of Governance, Planning & Risk The Governance & Support Services Manager The Customer Care & Experience Manager The Training & OD Advisor Reporting Incidents Line Managers Members of Staff Information Governance Related Incident Timings for Incident Reporting Incident Grading and Investigation Process - Including Root 14 Cause Analysis (RCA) 9.0 Levels of Investigation Sharing of Lessons Learnt Reporting to External Agencies 16 Version 2.0 Page 4 of 37 AUGUST 2015 (RM)

5 Health and Safety Executive - RIDDOR Estates and facilities Medicines and Healthcare Products Regulatory Agency (MHRA) Communication Commissioned services Procedure for Managing Provider Serious Incidents (excluding Family Health Services) Provider incidents identified by members of the CCG(22) Controlled Drugs Related Incidents in Primary Care(22) Monitoring and Reviewing Equality Impact Assessment 20 Appendices Appendix 1 Risk Matrix 21 Appendix 2 Root Cause Analysis (RCA) 25 Appendix 3 Overview of the investigation process 32 Appendix 4 Assigning Accountability: RASCI model 33 Appendix 5 The Never Events List 2015/16 35 Version 2.0 Page 5 of 37 AUGUST 2015 (RM)

6 INCIDENT REPORTING POLICY 1.0 INTRODUCTION NHS Trafford Clinical Commissioning Group s value of a commitment to quality care to improve lives states that the CCG is committed to ensuring our patients receive the best quality, co-ordinated care possible. To continually monitor and improve our services and how we commission them. In accordance with our values this policy and procedure sets out the framework for the comprehensive and systematic reporting of incidents, (including Serious Incidents (SIs) accidents and near miss events as a key element of improving patient safety and risk management activities within the organisation. The policy applies to all staff employed directly or indirectly by the CCG, including temporary and agency staff, independent contractors, Commissioning Support Unit and NHS England staff working on behalf of the CCG. The policy is designed to ensure that all staff have a clear understanding of their responsibilities and respond effectively to non-clinical and whilst rare, clinical incidents including SIs, requiring investigation. Incidents occurring in commissioned provider organisations should be reported and investigated internally in accordance with that provider organisation s policy and procedures. Provider incidents should not be reported to the CCG with the exception of: a) SIs which should be reported in accordance with provider s contractual obligations. b) Where an incident relating to a provider is identified by a member of the CCG in the normal course of their duties c) Controlled Drugs In the event of a child death or other serious incident involving a child(ren) there may be parallel processes in place, for example Child Death Overview Panel (CDOP), Serious Case Review/ alternative review or the Coronial process. In such cases, the time line for closing reported incidents will be determined by the relevant process. 2.0 POLICY AIMS The purpose of this policy is to outline the systems and processes in place to deal quickly and effectively with any incidents, accidents and near miss events that may occur within the CCG, to minimise the risk/s and/or losses to the organisation, patients, staff and others. The reporting of all incidents, accidents and near misses is designed to ensure a culture of openness in reporting, encourage quick, effective information gathering Version 2.0 Page 6 of 37 AUGUST 2015 (RM)

7 and reporting, and identification of trends and themes. The lessons learned should be utilised to reduce the risk of recurrence and to share good practice where identified. 2.1 Integrating Risk Management Activities Patient and staff safety issues arising from incident and accident reporting and monitoring need to be considered together with organisational risk areas such as complaints management, litigation and claims handling, financial and environmental risk. 2.2 A Duty of Candour and a Commitment to an Open and Fair Culture In any organisation incidents, accidents and near miss events can and will at some time occur, no matter how dedicated and professional the staff. When things go wrong, patients, staff and organisations are at risk of harm. The CCG recognises that an important part of successful risk management and the improvement of the quality of our service are to promote a fair and open culture and safe practice throughout the organisation. This will enable the CCG to identify trends and take positive action to prevent error and adverse incidents recurring. To promote a fair and open culture and encourage the reporting of incidents, the CCG will take a non-punitive approach to those incidents it investigates unless there is evidence of gross professional or gross personal misconduct; repeated breaches of acceptable behaviour or protocol; or an incident that results in a police investigation. The Francis Report following the Mid Staffordshire NHS Foundation Trust Public Inquiry stated every healthcare organisation and everyone working for them must be honest, open and truthful in all their dealings with patients and the public, and that organisational and personal interests must never be allowed to outweigh the duty to be honest, open and truthful. The Government s response to the Francis report agreed the key requirement is for a culture change within the NHS which values openness and transparency in all care delivery not just when things go wrong and the requirement for candour about mistakes should, in truth, be seen as part of a much wider commitment [of] an open and accountable service. Directly as a result of the Francis report, a statutory requirement has been introduced to ensure health care providers operate in a more open and transparent way. The regulation for Duty of Candour applied to health service bodies from 27 November It has been extended to all other providers from 1 April This regulation requires an NHS body to: Version 2.0 Page 7 of 37 AUGUST 2015 (RM)

8 Make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use services in carrying on a regulated activity Tell the relevant person in person as soon as reasonably practicable after becoming aware that a notifiable safety incident 1 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 the health service body s knowledge, is true of all the facts the body knows about the incident as at the date of the notification. Advise the relevant person what further enquiries the health service body 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 This supports the CCG s value of Honour, Integrity and Openness which states that we will be transparent in all our actions and decision making. When incidents occur the CCG will have an open approach when patients, relatives and carers have suffered harm as a result of an incident. They will be given an apology and explanation of what happened. This is NOT an admission of liability but an acknowledgement that untoward harm has occurred. It is the responsibility of the senior lead to inform patients, relatives and/or carers of any adverse incident that has resulted in an untoward outcome. 3.0 DEFINITIONS There are 3 reportable incidents these are: 1: Untoward Incident 2: SI 3: Near Miss 3.1 Untoward Incident An untoward incident is an unexpected or unplanned event that caused harm, or had the potential to cause harm, to a patient, member of staff, visitor, contractor or the CCG. These include: Personal accident. Personal accidents are accidental incidents which affect and/or involve a person or persons and resulted or could have resulted in injury. 1 means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in (a) the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user s illness or underlying condition, or (b) severe harm, moderate harm or prolonged psychological harm to the service user Version 2.0 Page 8 of 37 AUGUST 2015 (RM)

9 Violence, abuse, harassment. Incidents which cannot be reasonably said to be accidental in motive and include physical assaults by any person, deliberate self-harm, aggressive incidents, and other incidents involving verbal abuse, sexual or racial harassment, or intimidation or threatening behaviour. Ill health, work or environmental related incidents. Illness which is related to work or the environment and could include hospital acquired infections, industrial asthma and eczema. Unsafe environments, flooding, lighting/power/heating failure leading to of loss of services Security Incident. A security incident is one in which there is fraud, theft, deception, criminal damage, car crime, amongst other things involving staff, visitors to the CCG and its property. Clinical incident. A clinical incident is one which arises in the context of the duty of care owed to patients by members of the healthcare professions, or consequences or decisions or judgments made by those professions in their professional capacity or relevant work. 3.2 Serious Incidents (SIs) Serious Incident serious incidents are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. Serious incidents can extend beyond incidents which affect patients directly and include incidents which may indirectly impact patient safety or an organisation s ability to deliver on going healthcare. There is no definitive list of events/incidents that constitute a serious incident and lists should not be created locally as this can lead to inconsistent or inappropriate management of incidents. Serious Incidents in the NHS include: Acts and/or omissions occurring as part of NHS-funded healthcare (including in the community) that result in: Unexpected or avoidable death 2 of one or more people. This includes suicide/self-inflicted death; and homicide by a person in receipt of mental health care within the recent past 3 (see Appendix 1); 2 Caused or contributed to by weaknesses in care/service delivery (including lapses/acts and/or omission) as opposed to a death which occurs as a direct result of the natural course of the patient s illness or underlying condition where this was managed in accordance with best practice. 3 This includes those in receipt of care within the last 6 months but this is a guide and each case should be considered individually - it may be appropriate to declare a serious incident for a homicide by a person discharged from mental health care more than 6 months previously. Version 2.0 Page 9 of 37 AUGUST 2015 (RM)

10 3.3 Near Miss 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; or serious harm; Actual or alleged abuse; sexual abuse, physical or psychological illtreatment, 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/intervention to safeguard against such abuse occurring 4 ; or 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. See Never Events Policy and Framework for the national definition and further information; 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. ( see appendix 5 for the list of Never Events) Major loss of confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation. A situation during any activity that fails to develop further, whether or not, as the result of intervening action, but carried with it, the potential to cause harm (i.e. it almost happened ). A Near Miss may also constitute an SI, in that it was an event that has the potential to cause harm or was prevented from causing harm to one or more individuals, damage to property, a security breach or confidentiality breach. 4.0 ORGANISATIONAL RESPONSIBILITIES 4.1 The CCG Governing Body and the Chief Clinical Officer The CCG Governing Body and the Chief Clinical Officer hold corporate responsibility for pursuing the aims and objectives of risk management. This includes the implementation, dissemination monitoring and evaluation of the incident reporting procedures. However this responsibility is delegated to the Associate Director for 4 This may include failure to take a complete history, gather information from which to base care plan/treatment, assess mental capacity and/or seek consent to treatment, or fail to share information when to do so would be in the best interest of the client in an effort to prevent further abuse by a third party and/or to follow policy on safer recruitment. Version 2.0 Page 10 of 37 AUGUST 2015 (RM)

11 Corporate Services and Organisation Development with overall responsibility for the management of risk. 4.2 The Quality and Performance Committee The Quality and Performance Committee receive quarterly reports regarding incidents and SIs. The Quality and Performance Committee can request further assurances and refer incident reports to the CCG Governing Body. 4.3 The Clinical Director for Quality and Performance As Chair of the Quality and Performance Committee, the Clinical Director for Quality and Performance retains responsibility for the investigation of clinical SIs. 4.4 The Quality Team The Quality Team will StEIS (Strategic Executive Information System) report all SIs on behalf of the Head of Governance, Planning & Risk. The Quality Team will act as an expert resource, providing advice and guidance on the management, investigation and external reporting of SIs where required. 4.5 The Caldicott Guardian The Caldicott Guardian is responsible for ensuring the protection and use of patient identifiable information, which may be used during the incident reporting process. 4.6 The Head of Governance, Planning & Risk The Head of Governance, Planning & Risk is responsible for reporting work related deaths and major injuries to the Health and Safety Executive on behalf of the CCG. The Head of Governance, Planning & Risk should be notified of all SIs. 4.7 The Governance & Support Services Manager The Governance & Support Services Manager is the CCG s main contact with the NHSLA in the event of a likely claim and to handle any claims in accordance with the CCG s Claims Management Procedure. 4.8 The Customer Care & Experience Manager The Customer Care & Experience Manager will receive and review all incident reports. If, in their opinion, there is a potential for the incident to be of a serious nature he/she will immediately inform the Associate Director for Corporate Services and Organisation Development, Head of Governance, Planning & Risk and if the incident relates to a clinical matter, the Clinical Director for Quality and Performance, or an alternative clinically qualified member of staff if unavailable. Version 2.0 Page 11 of 37 AUGUST 2015 (RM)

12 The Customer Care & Experience Manager will ensure that any complaints arising from incidents are managed in accordance with the CCG s Complaints Policy & Procedure. 4.9 The Training & OD Advisor The Training & OD Advisor will have responsibility for leading on health and safety related incidents affecting employees whilst working remotely or working in the CCG office. 5.0 REPORTING INCIDENTS All incidents should be reported using the web based incident and risk reporting form (incident form). The incident form and user guidance is accessed through the CCG s intranet site. It is the responsibility of all staff to report an incident within 48 hours (or within 24 hours if serious). When reporting an incident, staff should not make assumptions, should only include the known facts relating to the incident and refrain from including personal opinion. The incident form should be completed to provide a comprehensive report of the events and any actions taken following the incident. The relevant Line Manager will review the incident as reported and after making enquiries that may be necessary, grade the incident in accordance with the risk matrix in section 8 of this policy. In the event of the person affected not being able to complete the incident form, it is the responsibility of the person in charge of the area at the time of the incident to complete the form. The person affected should then be given the opportunity to provide his or her own account of the incident. In the event of a SI, reporting is immediate to the Line Manager or the person in charge at the time of the event, who will as soon as practicable ensure the Senior Manager/Head of Service and the Head of Governance, Planning & Risk is informed. The Head of Governance, Planning & Risk and /or the Customer Care and Experience Manager will inform the Quality Team where appropriate. This applies to all incidents that are graded as an Extreme or High Risk and/or have a consequence grading of Serious or Catastrophic. During out of hours the CCG s on call Manager should be contacted (who will, if necessary, pass the information to the Director on call). The incident must then be passed onto the relevant Senior Management Lead (or a designated lead) who will ensure a thorough review and an investigation into the incident causation is undertaken. Whilst unlikely, in the event that a CCG attributable SI results in the physical harm of a patient the Head of Governance, Planning & Risk and /or the Customer Care and Experience Manager will inform the Quality team as soon as reasonably practicable. Version 2.0 Page 12 of 37 AUGUST 2015 (RM)

13 The Quality team will report the incident into StEIS as per the Serious Incident Framework Line Managers The Line Manager is the first point of contact for staff who have witnessed an incident. Line managers must complete risk assessments for incidents and develop and implement risk reduction action plans. Line managers must also ensure that staff are made aware of the deputising arrangements when they are on leave or unavailable. It is recognised that feedback to staff is a vital element of the incident reporting procedure. Line managers (at all levels) must ensure that they have systems in place, to provide feedback to staff that have reported Incidents 5.2 Members of Staff The member of staff involved in or witness to an incident, should complete the incident form and inform their line manager. Only one incident form should be completed per incident. On submission the incident form will be automatically sent to a hold file to be reviewed and merged on to the incident database by the Customer Care and Experience Manager. Any remedial action that is undertaken or planned should be noted on the submission. The immediate priority for all staff in the case of an incident is to take steps necessary to secure the safety of the staff member and other people involved. Prompt action must be initiated to prevent a reoccurrence of any incident or to minimise the risk of a near miss or potential incident from materialising into an actual incident. The type of immediate action required varies according to the nature of the occurrence. SIs that relate to the CCG and not to a provider must be reported in accordance with this policy. This includes completing an incident form and reporting the incident to the Head of Governance, Planning & Risk and, if the incident relates to a clinical matter, the Clinical Director for Quality and Performance, or an alternative clinically qualified member of staff if unavailable by the fastest means available, usually by telephone or INFORMATION GOVERNANCE RELATED INCIDENT An information governance or information security related incident relates to breaches of security and /or the confidentiality of personal information. The information could relate to paper file, computer records or hand written notes. Information governance or information security related incidents should be reported and acted on in accordance with Trafford CCG s Information Governance Incident Reporting Procedure. Version 2.0 Page 13 of 37 AUGUST 2015 (RM)

14 7.0 TIMINGS FOR INCIDENT REPORTING Incident forms should be completed within the timescales detailed below in so far as is practicable. Extreme Risk High Risk Moderate Risk Low Risk Immediate reporting (24 hours) Immediate reporting (24 hours) Reporting within 36 hours Reporting within 48 hours 8.0 INCIDENT GRADING AND INVESTIGATION PROCESS - INCLUDING ROOT CAUSE ANALYSIS (RCA) It is essential that all incidents are fully investigated by line management. The amount of time and effort put into the investigation will vary dependent upon the nature and severity of the event. The prime objectives should be: a) To determine the sequence of events leading up to the incident. b) To establish the unsafe acts and/or unsafe conditions within this sequence which were the immediate causes of the incident. c) To determine the human, organisational and/or work related factors that gave rise to the unsafe acts and/or conditions. d) To implement remedial action to eliminate the immediate causes and establish a longer-term action plan to correct and control the underlying causes, and hence prevent in so far as is reasonably practicable a recurrence of the same or similar incident. Following any incident the Risk Matrix (Appendix 1 ) should be used to determine the consequence or impact of the incident upon the individual involved, the service and/or the organisation, and also the likelihood of occurrence. This process will then enable the incident to be graded (scored). The initial incident grade should be determined by the member of staff reporting the incident and can be regarded by or in discussion with the line manager, service lead, the Director, or Associate Director and/or Customer Care and Experience Manager. If a previous risk assessment has been undertaken for the task and/or the work area involved then this should be reviewed in light of the incident. If no assessment has been made then the incident should serve to trigger the assessment process. The Line Manager responsible for the individual involved or the area in which the incident occurred must investigate all incidents graded as Low Risk. Any incidents graded as Moderate Risk or High Risk, the Director, Associate Director or the Service Lead responsible for the individual involved or the work area in which the incident occurred must ensure that an investigation is undertaken. Version 2.0 Page 14 of 37 AUGUST 2015 (RM)

15 SIs will be reported to NHS England via the Strategic Executive Information System (StEIS) by the Quality team and also be subject to a full Root Cause Analysis (RCA). A Senior Manager/Designated Lead will or conduct the Root Cause Analysis as defined within the procedural guidance outlined in section two of this policy. Only those staff sufficiently trained in Root Cause Analysis techniques will be able to facilitate this more detailed investigative process. The tools used for Root Cause Analysis can be found on the NPSA website and are detailed in appendix 2 below. Where appropriate external agencies may be contacted and involved in the investigative process. Following any investigation it may be appropriate for the incident to be re-graded to reflect a new level of risk. The initial and final grading will be recorded. When SI is complete it will be considered by an appropriate committee/steering Group or the Senior Management Team to discuss the points noted below. The appropriate committee/steering Group or Senior Management Team will be determined based on the matter of the incident. a) How the incident was handled. b) What implications there may be for the CCG i.e. legal action, and how this should be managed? c) Any lessons which could be learnt for the future d) A brief report and action plan covering the incident from beginning to end. e) Debrief and counselling should be arranged for staff as appropriate 9.0 LEVELS OF INVESTIGATION Some incidents may not require immediate investigation but most will require immediate management actions to prevent any further harm or damage. It is the responsibility of the Line Manager (subject to the level of risk identified) to investigate the incident and record their findings and action taken on the incident form, or separately if necessary. All SIs will require Root Cause Analysis SHARING OF LESSONS LEARNT All teams/directorates will ensure incident outcomes are shared. Through the analysis of incidents all associated risks will be reported directly to the appropriate Director/Associate Director and where necessary added to the CCG risk register. Version 2.0 Page 15 of 37 AUGUST 2015 (RM)

16 Learning from incidents will be shared at an organisational level through quarterly reporting to the Quality and Performance Committee REPORTING TO EXTERNAL AGENCIES 11.1 Health and Safety Executive RIDDOR The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (as amended 6 April 2012) places a legal duty on the CCG to report work-related deaths, major injuries or injuries that result in incapacitation for more than seven days, work related diseases, and dangerous occurrences (near miss accidents). The CCG is no longer required to report work related injuries that result in more than three days of incapacitation but less than 7 days of incapacitation, however the CCG is required to keep a record of such injuries. The Head of Governance, Planning & Risk will carry out RIDDOR reporting to the HSE on behalf of the CCG. When an incident has been identified as RIDDORreportable, the Head of Governance, Planning & Risk should be notified as soon as possible. In SI resulting in major injury or death, the Health and Safety Executive need to be alerted immediately ( Outside of normal working hours an appropriate Director/Associate Director or the senior manager on-call should do this. If there is an accident connected with work (including an act of physical violence) resulting in an employee suffering an over-seven-day injury it must be reported in compliance with the above regulations within 15 days. An over-7-day injury is one which is not major but results in the injured person being away from work OR unable to do their full range of their normal duties for more than seven days. It is the Line Manager s responsibility to ensure that the Head of Governance, Planning & Risk or Training & OD Advisor is contacted within 24 hours. The Health and Safety Executive will require the following information: - Date and time of incident Location of incident Name, home address, gender and status of persons involved / affected Details of any injuries Confirmation as to whether the situation is under control or whether assistance is required Brief outline of the circumstances of the incident Details of any witnesses. Version 2.0 Page 16 of 37 AUGUST 2015 (RM)

17 11.2 Estates and facilities All urgent health and safety estates issues for CCG properties should be reported by the Line Manager to the CCG Administration Manager Medicines and Healthcare Products Regulatory Agency (MHRA) Any adverse incident involving a medical device should be reported as soon as possible. Electronic reporting using the online form on the MHRA website ( is the preferred method. The Medicines Management Team will report adverse reactions to medication to the MHRA COMMUNICATION If an incident is likely to result in media coverage, effective communication with staff is paramount to avoid reacting to rumours the media may pick up. The timing and the extent of any information issued to staff will be decided by the incident team but may include a special team brief. Patients, families, staff and other organisations should be informed before the media. All incidents likely to result in media coverage should be reported to the Associate Director of Corporate Services and OD, who will take responsibility for managing media relations COMMISSIONED SERVICES Incidents occurring in commissioned provider organisations should be reported and investigated internally in accordance with the provider organisation s policy and procedures. Provider incidents should not be reported to the CCG with the exception of: a) An SI the provider must inform the Quality team of all SIs. b) Where an incident relating to a provider is identified by a member of the CCG in the normal course of their duties (see below). c) Controlled Drugs related incidents in Primary Care (see below) Procedure for Managing Provider Serious Incidents (excluding Family Health Services) In the event of an incident the provider should enter all relevant and known details about the incident on the NHS serious incident management system (STEIS or its successor). The provider should inform the relevant CCG incident/quality Lead 5. 5 Where there are multiple commissioning organisations involved, this Framework encourages providers and commissioners to establish a lead commissioning model (wherever possible) so that the provider engages with one commissioner on a frequent basis. Version 2.0 Page 17 of 37 AUGUST 2015 (RM)

18 Where an incident arises in a small provider who does not have access to StEIS, the Quality Team will enter the incident into StEIS on their behalf. The principle accountability of all providers is to patients and their carers/families. This means that the first consideration following an SI must be the patient s welfare. They must be cared for, their health and welfare secured, and they must be fully involved in the response to the SI. Where a patient has died or suffered serious harm, their family must be similarly cared for and involved. The Quality Team will hold the provider to account in regard to the principles of openness and honesty as outlined in the NHS Being Open guidance. The NHS contractual Duty of Candour 6 must be applied in discussions with those involved. This includes staff and patients, victims and perpetrators, and their families and carers. The Serious Incident Framework (2015) states that there is no definitive list of events/incidents that constitute a serious incident, and lists should not be created locally as this can lead to inconsistent or inappropriate management of incidents. However, the quality team have devised a minimum data set of incidents that they would expect as a minimum to be reported by the providers as a serious incident. This is to promote consistency across the providers. Where a new area has been identified that the provider has not traditionally been reporting against, there will be a phased approach taken to allow the provider to implement. An initial review (characteristically termed a 72 hour review ) should be undertaken; this should be completed within 3 working days of the incident being identified. The aim of the initial review is to: Identify and provide assurance that any necessary immediate action to ensure the safety of staff, patients and the public is in place; Assess the incident in more detail (and to confirm if the incident does still meet the criteria for a serious incident and does therefore require a full investigation); and Propose the appropriate level of investigation. The quality team will liaise with the provider, as a 72 hour review may not be required in all cases. When a review is required, the 72 hour review should be put as an update into StEIS by the provider The provider has to conduct an internal investigation and produce the investigation report within 60 days. The quality team will review the investigation report within 20 days, and seek further assurances if required from the provider. Once satisfied that the investigation report has captured the lessons learned and recorded these within 6 The Department of Health has introduced regulations for the Duty of Candour. It requires providers to notify anyone who has been subject (or someone lawfully acting on their behalf, such as families and carers) to a notifiable incident i.e. incident involving moderate or severe harm or death. This notification must include an appropriate apology and information relating to the incident. Failure to do so may lead to regulatory action. Further information is available from Version 2.0 Page 18 of 37 AUGUST 2015 (RM)

19 an action plan, the incident will be closed on StEIS. It is the provider s responsibility to update StEIS with the root causes and the lessons learned. The quality team will then close the StEIS form. The quality team will seek assurance from the provider on the timeliness of the completion of action plans. Please refer to Appendix 2 for an overview of the process for managing Provider Serious Incidents. The CCG respects the role of the service provider in investigating their own serious untoward incidents, but reserves the right to review the quality of an investigation and request amendments to investigations or action plans, if this is judged necessary, in the interest of safety and prevention of further incidents. Some SIs span across other organisations. Therefore it may be necessary to undertake joint SI Investigations or to ensure that other organisations are aware and updated on the CCG s investigation and its findings and safety lessons are shared, in line with the principles of RASCI (Responsible, Accountable, Supporting, Consulted and Informed). A lead commissioner role should be agreed in relation to serious incidents in providers with multiple commissioners in order to provide a clear communication channel between the provider and commissioning system. (See Appendix 3 for guidance on the RASCI model) 13.2 Provider incidents identified by members of the CCG. If a member of the CCG identifies an incident as part of their normal course of business, the member of staff will complete an incident form and notify their Line Manager. The member of staff or Line Manager should contact the provider to discuss the incident and seek assurances that corrective action has or will be taken. If the provider does not provide sufficient assurance or the incident is considered to be a SI the incident will be forwarded to the Quality Team to investigate Controlled Drugs Related Incidents in Primary Care If an incident regarding the use/prescribing of controlled drugs is identified in a primary care setting, the incident will be reported using the CCG s incident form. In additional the medicines management team will report the incident to NHS England via NHS England s web based Controlled Drugs incident reporting tool. NHS England will retain responsibility for investigating the incident MONITORING AND REVIEWING This policy will be monitored for compliance with reporting to external agencies and will be reviewed and updated on. Version 2.0 Page 19 of 37 AUGUST 2015 (RM)

20 15.0 EQUALITY IMPACT ASSESSMENT The Equality Impact Assessment Checklist is completed and forwarded with this document to the group committee responsible for approval of the document. This provides evidence that an impact assessment has been undertaken. Version 2.0 Page 20 of 37 AUGUST 2015 (RM)

21 Appendix 1 Risk Matrix The risk matrix in Figure 3 below includes risk scores and colour coding. The highest (extreme) scoring risks are coloured red. High risk are coloured Orange and scored between 8 and 12, with yellow, moderate risks between 4 and 6. The lowest scoring risks 1-3 are green. To score a risk and select a colour, follow the steps below. Step 1 Establish the Likelihood of Reoccurrence score (Figure 1) and Impact of Harm score (Figure 2) Step 2 Multiply the scores together to get a risk score between 1 and 25 Step 3 Use the Risk Matrix (Figure 3) to identify the colour of the risk. This will identify the level at which the risk will need to be managed. Figure 1: Likelihood Score Score Likelihood Description 1 Rare Only occurs in exceptional circumstances, <1%, 1-5 year strategic risk 2 Unlikely Could occur at some time, 1-5%, at least annually 3 Possible Should occur at some time, 6-20%, at least monthly 4 Likely Will probably occur, 21-50%, at least weekly 5 Almost Certain Expected to occur, >50% at least daily Version 2.0 Page 21 of 37 AUGUST 2015 (RM)

22 Figure 2: Impact of Harm Score Descriptor Score 1 Insignificant 2 Minor 3 Moderate 4 Major 5 Catastrophic A Objectives / projects Insignificant cost increase / schedule slippage. Barely noticeable reduction in scope or quality. <5% over budget / schedule slippage. Minor reduction in quality / scope. 5-10% over budget / schedule slippage. Reduction in scope or quality % over budget / schedule slippage. Doesn t meet secondary objectives. >25% over budget / schedule slippage. Doesn t meet primary objectives B Injury C Patient experience D Complaints / claims E Service / business interruption F Staffing and skill mix G Training H Financial / asset I Inspection / audit Minor injury not requiring first aid. Unsatisfactory patient experience not directly related to patient care. Locally resolved complaint. Minor injury or illness, first aid treatment needed. Unsatisfactory patient experience readily resolvable. Justified complaint peripheral to clinical care. RIDDOR / Agency reportable. Mismanagement of patient care. Justified complaint or claim, involving lack of appropriate care. Major injuries or long-term incapacity / disability. Serious mismanagement of patient care. Multiple justified complaints or claims. Loss / interruption>1 hour. Loss / interruption>8 hours. Loss / interruption>1 day. Loss / interruption>1 week. Short term low staffing level temporarily reducing service quality<1 day. Staff lacking confidence in their knowledge base. On going low staffing level reducing service quality. Near miss or poor work due to lack of training. Late delivery of key objective / service due to lack of staff. on going unsafe staffing. Minor error due to poor training. Uncertain delivery of key objective / service due to lack of staff. Serious error due to poor training. Death or major permanent incapacity. Totally unsatisfactory patient outcome or experience. Multiple claims or single major claim. Permanent loss of service or facility. Non-delivery of key objective / service due to lack of staff. Critical error due to insufficient training. Small loss. Loss>0.1% of budget. Loss>0.25% of budget. Loss>0.5% of budget. Loss>1% of budget. Minor recommendations. Minor non-compliance with standards and/or policies. Recommendations given. Non-compliance with standards and/or policies. Reduced rating. Enforcement action. Prosecution. Challenging recommendations. Non-compliance with core standards and/or policies. Critical report and Low rating. Major non-compliance with core standards and/or policies. Zero rating. Severely critical report. J Adverse publicity / reputation Rumours. Local media short term. Minor effect on staff morale. Local media long term. Significant effect on staff morale. National media<3 days. National media>3 days. MP concern (questions in the House). Version 2.0 Page 22 of 37 AUGUST 2015 (RM)

23 K Stress and anxiety Bad language causing upset. Direct verbal abuse causing upset. Persistent verbal abuse or harassment. Direct and threatening language or behaviour. Repeated victimisation or advances. Diagnosed physical symptoms of stress leading to persistent absence from work. Issues causing concern. Anxiety causing minor work disruption. Persistent worry affecting work. Repeated absence and/or notably poor productivity. Claim or action against the organisation. Version 2.0 Page 23 of 37 AUGUST 2015 (RM)

24 Figure 3: Risk Matrix Likelihood Impact of Harm Low Risk (1-3) Moderate Risk (4-6) High Risk (8-12) Extreme Risk (15-25) Following the risk assessment process, one has to consider what action, if any, is required to manage a particular risk / risks. It may be that the level of risk is felt to be acceptable within existing controls. Alternatively, it may be that a reduction in the level of risk is required. Consideration needs to be given to the level, type and cost of control required to manage a specific risk, the benefit that this may have on likelihood and impact as well as ensuring that accountability and responsibility for delivering the action plans to manage / reduce risk has been assigned. Risks calculated as 15 and above should be considered for escalation to a SI. All individual incidents that lead to catastrophic outcomes must be escalated immediately as a SI. Version 2.0 Page 24 of 37 AUGUST 2015 (RM)

25 Appendix 2 ROOT CAUSE ANALYSIS (RCA) 1.0 INTRODUCTION: This RCA process aims to assist nominated lead investigators to successfully investigate and resolve SI s, complaints and claims, as defined by the risk matrix. It allows the investigator to identify the direct, contributory and root causes associated with the incident. 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. By analysing such occurrences we can ensure lessons are learnt and practice is changed appropriately, the investigation will help address areas of poor performance, systems failures, violations of procedures, and the need for changes in both clinical and nonclinical practice. This procedure should be read in conjunction with: The Risk Management Strategy and Policy Incident Reporting Policy The Claims Handling Policy and Procedure Complaints Policy and Procedure Definitions: Root Causes Root Cause Analysis (RCA) Immediate Causes /Active Failures Underlying Causes /Latent Failures Failures in processes that if eliminated, would prevent an adverse incident from reoccurring. 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. Apparent reasons why the event occurred, that need to be analysed to determine underlying influences. Underlying factors or influences that need to be analysed to determine the root causes. When does a Root Cause Analysis need to be conducted? Using the Risk Matrix an incident can be graded in severity. If the incident is deemed serious in nature and therefore scores red on the matrix, an investigation procedure needs to be initiated. Version 2.0 Page 25 of 37 AUGUST 2015 (RM)

26 2.0 UNDERTAKING THE INVESTIGATION: It is not proposed in this procedure to undertake a detailed explanation of root cause analysis. However, investigations need to consider the following key points in order to be considered successful. Assign a team, which ideally should be between 2 5 individuals. The team should have an appointed independent lead investigator/chairperson trained in RCA. Utilise other individuals skills and knowledge i.e. use multidisciplinary teams. Outline the sequence of pertinent events may need to physically chart sequence. Avoid early judgements, blame or attribution. Concentrate on the facts only and avoid subjectivity. Identify the causal factors leading up to each pertinent event. In most cases the incident does not result from one single event, but is more likely to have evolved cumulative triggers, which in isolation may have had no effect, but when they occur in the event chain may be serious or catastrophic in nature. Methodology may need to include a variety of approaches: Interviews, statement writing, review of documentation and direct observation. Analyse the causal factors. Provide a report including the RCA techniques used (examples as listed below). Brainstorming Change Analysis Fishbone Diagram Nominal Group Technique Proactive Barrier Technique Reactive Barrier Technique RCA Timeline The 5 Whys? The templates and guidance for the RCA techniques noted above can downloaded from the NPSA website at: Complete the root cause matrix. Provide recommendations to the CCG, which may prevent the reoccurrence of the incident. Version 2.0 Page 26 of 37 AUGUST 2015 (RM)

27 3.0 EXTERNAL AGENCIES The CCG will endeavour to work with any external agencies that could assist in the effectiveness of root cause analysis, and ensure lessons are learned and recommendations implemented. It may be necessary, on occasion, to include external agencies in the root cause analysis procedure. 4.0 ROOT CAUSE ANALYSIS PROCESS 1. What happened? 1. How did it happen? 2. Witnesses 2. Casual factors 1. Why did it happen? 1. Recommendations 3. Physical Evidence 3. What happened 2. Findings made. If accepted 4. Sketches or throughout the 3. Probable causes appoint a lead Photographs chain of events? 4. Judgments of need implementer. 5. Records and 4. Focus on problem- Documentation solving not on blame. 6. Medical Evidence etc 5. System and process Based don t concentrate On the individual Version 2.0 Page 27 of 37 AUGUST 2015 (RM)

28 ROOT CAUSE MATRIX Material and Organisational People External Equipment Design Staffing Training Weather/ environment Layout and Procedure/policy Time Building housekeeping pressure Quality Risk assessment Communicati on Visitor/3rd party Lack of PPE Supervision Installation Medicine/drugs Patient behaviour Maintenance Version 2.0 Page 28 of 37 AUGUST 2015 (RM)

29 Major cause Lead Investigators should refer to list below for more guidance on root causes Moderate Cause Minor Cause 5.0 RISK FACTORS a) Natural Disaster or Criminal Activity b) Equipment Failure Expected Failure Design Specifications Specifications have potential for improvement (PFI). Design not to specification Work/equipment interface not considered Design Suitability New equipment not up to standard (PFI) Hazard analysis (PFI) Equipment/Part Defective Purchasing Handling Storage Quality assessment Manufacturing defect Planned Preventative Maintenance PPM No PPM Repeated Failures Management system Corrective active Version 2.0 Page 29 of 37 AUGUST 2015 (RM)

30 6.0 PERFORMANCE DIFFICULTIES Individual Performance Excessive tiredness, unwell, upset, bored, distracted, overwhelmed. No written procedures Written procedure not followed. Made a mistake using procedure. Equipment alarms turned down or off. Not trained to carry out the task or understand the equipment. Work environment not conducive to safe practice e.g. dark, hot, humid etc. Did task involve repetitive motion, uncomfortable positions, vibration, or manual handling? Team Performance Was there a problem with verbal communication or shift change over. Were there language difficulties between parties. Was time available to explain procedures/risk to family/patient. Did a failure in the case notes contribute? Management Systems Was there pressure to perform the task in a hurry or to use shortcuts. Had management been warned of the problem before. Were policies, procedures or administrative controls not used, missing or in need of improvements. Was there a failure in the provision of tests and results. Would an independent audit have highlighted the problem earlier? Procedures Procedures not used, or procedures not followed Wrong procedures Followed incorrectly. Training No training Training outcome has a PFI Communication Non-existent or untimely Handover has PFI Misunderstood verbal communications Work Direction Preparation Selection of worker Supervision during work Quality Control No inspection Version 2.0 Page 30 of 37 AUGUST 2015 (RM)