INCIDENT MANAGEMENT POLICY AND PROCEDURE (Including Procedure for Serious Adverse Incidents) Reference Number:

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1 INCIDENT MANAGEMENT POLICY AND PROCEDURE (Including Procedure for Serious Adverse Incidents) Reference Number: NHSCT/09/127 Responsible Directorate: Medical & Governance Replaces (if appropriate): Incident Reporting Policies pertaining to Homefirst, Causeway and United legacy Trust areas Policy Author/Team: Mr Alex Lynch Corporate Risk Manager Type of document: Corporate Policy and Procedure Review Date: 30 November 2010 Approved by: Trust Board on 23 October 2008 and Governance Management Board on 27 January 2009 Date Policy disseminated by Equality Unit: 19 March 2009 NHSCT MISSION STATEMENT To provide for all the quality of services we would expect for our families and ourselves

2 Incident Management Policy and Procedure (including procedure for Serious Adverse Incidents) (Approved 18 December 2008)

3 Contents Page Number Part 1: Incident Management Policy Statement 1. Policy Statement 2. Responsibilities 3. Communicating with service users/carers 4. Commitment to staff Part 2: Incident Management Procedure 1. Definitions 2. What incidents are to be recorded and reported 3. Procedure for reporting incidents 4. Responsibilities 5. Investigating incidents 6. Feedback, review and monitoring arrangements Part 3: Serious Adverse Incident Management Procedure 1. Objectives 2. Definition of a Serious Adverse Incident 3. Procedure (including assignment of responsibilities) for identifying and processing a Serious Adverse Incident 4. Securing Papers for Independent Inquiries, Case Management Reviews or Inquests Appendices 1. Being Open communicating with service users and/or their carers 2. Forms of support to be provided to staff by the Trust during management and investigation of a serious clinical or social care incident 3. Procedure for recording and reporting incidents (flowchart) 4. Actions and responsibilities of staff 5. Trust Incident Report Form (to follow)

4 6. Procedure for identifying and processing Serious Adverse Incidents including examples of possible SAI Trigger Incidents/Events 7. Risk Grading System Health and Social Care Regional Template and Guidance for Incident/Investigation/Review Reports 9. NHSST Patient Safety Investigation Report and Guidance (for use in less complex investigations)

5 Introduction This policy and procedure describes arrangements for recording, reporting and managing, incidents including those deemed to be Serious Adverse Incidents. It represents an important element of the Trust s Risk Management Strategy and details the roles and responsibilities of staff at all levels of the organisation for delivery of that Strategy. It is applicable to all staff employed by or working for the Trust regardless of the contractual arrangement under which engaged. The scope of the policy extends to all service users, staff, visitors and any other person to whom the Trust owes a duty of care. The Trust requires third party organisations from which it commissions services to operate appropriate arrangements for recording incidents and notifying the Trust in a timely way. This document has the following elements: * Part 1 - Policy Statement * Part 2 - Incident Management Procedure * Part 3 - Serious Adverse Incident Management Procedure In order to minimise the size of this document, only the appendices that are essential for understanding the policy and procedure have been included. The other appendices are important for a full understanding of the Trust s approach to reporting, investigating and managing incidents, but it is not required by all staff. These appendices will only be posted on the Intranet. Part 1 Policy Statement 1.0 Policy Statement 1.1 Risk management is central to the Trust s strategic and operational processes to ensure it can achieve its objectives and maximise resources. 1.2 Amongst the eight risk factors for serious service failures identified in the Healthcare Commission s Report Lessons from CHI Investigations 2003 was ineffective risk management including inadequate incident reporting. Accordingly, as recommended in Safety First: A Framework for Sustainable Improvement in the HPSS (HPSS 2006) the Trust recognises that incident reporting is a fundamental tool of risk management. Learning from and changing practice as a result of any adverse event which occurs is an essential element of risk management within the Trust. 1.3 Managers and staff are individually responsible for reporting adverse incidents they may identify in compliance with this policy. Adverse incident includes incidents, near-misses, concerns, serious incidents, unexpected clinical and care outcomes. 1.4 Reporting will be regarded as a positive action to improve standards of service delivery and safety in accordance with the duty of care owed by the Trust to service users, visitors and staff. The Trust has a statutory duty and responsibility to report incidents to external agencies. 4

6 2. 0 Responsibilities 2.1 The Trust s Risk Management Strategy details the responsibilities of staff at all levels of the organisation for risk management including incident recording and reporting Communicating with service users and/or their carers 3.1 In the event of the occurrence of an incident which has resulted in harm to a service user the principles contained in the National Patient Safety Agency s Being Open Policy will be adopted and a Being Open meeting will be offered to the service user/and or their carers. 3.2 The Ten Principles of Being Open together with examples of issues to be discussed at the meeting are detailed at Appendix As soon as possible after an incident that has resulted in serious harm or death the Director will initiate a Being Open meeting. Where the service user is unable to participate it may be deemed appropriate to discuss the incident with the next of kin. 3.4 The service user and/or carers will, at the earliest opportunity, be offered a full and honest explanation and given an apology. 4.0 Commitment to staff 4.1 The Trust is committed to developing and maintaining a fair and just organisational culture which fosters peer support and discourages the attribution of blame. Within that culture whilst staff are accountable for their actions it is also recognised that blame is the enemy of learning and that human error is understood to be frequently the consequence of failures in systems, and not necessarily of the individual. 4.2 The Trust views incident reporting as a positive action and will promote it by operating an investigation process which is: fair and equitable; focused on identifying both contributory and root causes; focused on learning and improving; ensures staff engagement and inclusion; and within which staff are provided with all appropriate support (Appendix 2 refers) 4.3 In investigating an incident the emphasis will be on learning lessons and considering wider organisational issues, not on blaming individuals. Staff must feel safe to report any incident and contribute to investigations having confidence that information provided by them will be treated with respect and trust. 4.4 This means that the investigation of an incident will rarely result in disciplinary proceedings being instigated by the Trust and only when it is considered that there was: 5

7 an intention to cause harm or achieve other adverse outcome; a criminal act; foreseeability in putting the safety of service users, staff or others at risk; gross negligence and/or recklessness, including deliberate failure to follow safe practice, procedure or protocols; or repeated similar occurrences involving the same member of staff. 4.5 Advice will be sought from the Director of Human Resources, where, during the course of an investigation, any of these factors is considered to be present. Part Two - Incident Management Procedure 1.0 Definitions 1.1 The following terms describe events, which are defined as incidents and will be recorded and reported under this procedure Incident/Accident An unexpected or unintentional event which resulted, or could have resulted, in injury to a person or damage to property or to the environment, or a breach of security or confidentiality Adverse event Any event or circumstances that could have or did lead to harm, loss or damage to people, property, environment or reputation. ( Safety First A Framework for Sustainable Improvement in the HPSS DHSSPS) Serious Adverse Incident A grossly exceptional incident involving the Trust, its staff, service users or any other person affected by its activities and which has, or has the potential to: require regional action to improve safety or care within the broader HPSS; be of public concern; require an independent review. (Circular HSC (SQS) 19/2007: Reporting and follow-up on serious adverse incidents and reporting of breaches of patients waiting in excess of 12 hours in Emergency Care Departments to the Department of Health, Social Services and Public Safety). 6

8 Also apparently less significant incidents but which may have disproportionate ramifications, including those which could attract national or very significant local media interest Harm Injury (physical or psychological), disease, suffering, disability or death. In most instances harm can be considered to be unexpected if it is not related to the natural cause of the service user s illness or underlying condition. ( Doing Less Harm, National Patient Safety Agency) Near miss A situation in which an event or omission, or a sequence of events or omissions, arising during service delivery fails to develop further, whether or not as the result of compensating action, thus preventing injury to service user, staff or others. Incidents that did not lead to harm, but could have, are referred to as near misses. ( Doing Less Harm, National Patient Safety Agency) Concern A worry or gut feeling about something which could potentially lead to an incident; To highlight a situation which could lead to a full-blown incident; or Sub-optimal standard of equipment, practice or performance. 2.0 What is to be recorded and reported 2.1 Lists of examples of reportable clinical trigger events by speciality, are available on the Incident Reporting Procedure Intranet Appendices. These examples will normally require reporting on the Trust s Incident form. These lists are not exhaustive Patient/Client Safety Incident An incident (event or near miss) involving a service user which had an actual or potentially adverse outcome which would not be expected to occur in the routine course of events. And whether or not occurring during the provision of services directly from the Trust or being provided on the Trust s behalf by another organisation from whom services were being commissioned for the service user by the Trust. Or being provided on Trust premises by employees of another HPSS organisation. 7

9 2.1.2 Personal Incident Any incident which is not related to receipt of care or treatment involving a person on Trust Violence, abuse or harassment Fire Any incident involving verbal abuse, anti-social behaviour, racial, religious or sexual harassment or physical assault whether or not injury results. Any incident, no matter how small, involving fire or activation of fire alarm system, including false alarms Security Any incident involving theft, loss or damage (whether accidental or malicious) to property belonging to the Trust, or a service user, member of staff or other person for whom the Trust has responsibility. Also unauthorised intrusions onto Trustowned premises, absconding service users and other security incidents Vehicles Any incident involving a vehicle owned or being operated by or on behalf of the Trust including Road Traffic Accidents involving privately owned vehicles being used by staff during the course of their duties Publicity Any incident which may lead to adverse publicity, litigation or loss of public confidence in the Trust Financial Any loss of financial or other assets owned or operated by the Trust Information governance Any breach of patient/client/staff confidentiality, or loss of personal or other sensitive data, or unavailability or misplacement of records. Examples of such incidents are listed at Appendix Others Examples might include environmental incidents such as accidental discharges to drains or into the atmosphere, food hygiene/safety incidents, radiation, sharps, equipment and medical devices. 3.0 Procedure for reporting incidents 3.1 The procedure for recording and reporting incidents is displayed diagrammatically at Appendix 3. 8

10 4.0 Responsibilities Responsibilities for all staff in the event of an incident occurring are detailed at Appendix 4 and which are summarised below Staff involved in incidents All incidents as defined above must be reported to the line manager immediately after having ensured that, where required, medical attention has been provided and/or the area in which the incident occurred has been made safe Details of the incident must be formally recorded and reported by completing a Trust Incident Report Form (Appendix 5). The form must be completed, by either the member of staff who was involved in or witnessed the incident, or by the person the incident was reported to, by not later than the end of the working shift or day during which it occurred or its occurrence became known Information concerning the incident must be accurate, complete and factual. It should not contain opinions, conclusions or include subjective or speculative statements. It must not contain any comment on liability or fault on the part of the Trust or its staff Where the incident involves an adverse outcome to a clinical procedure it is particularly important that, at the earliest opportunity, the staff involved prepare a report documenting their involvement. In all cases the names and contact details of witnesses to the incident must be recorded on the Incident Report Form In circumstances where the incident is considered as possibly being a Serious Adverse Incident (Part 3 refers) immediate telephone contact must be made with the responsible line manager and/or the appropriate operational Director After the basic information has been entered onto the form it must be forwarded to the line manager for its completion by them. 4.2 Line Manager The line manager will complete the comments and actions taken section of the Incident Report Form. This will include details of any investigations undertaken following the incident and any plans put in place to prevent or reduce the risk of recurrence. If additional space is required a separate sheet can be used and attached Any further immediate action necessary to make the situation safe should also be taken and recorded Using the Trusts risk grading matrix (Appendix 12) the manager will grade the incident according to the actual Impact/Consequences. Near misses will be graded according to potential Impact/Consequences Incidents graded as Extreme or High will require urgent consideration to determine whether or not to be managed as a Serious Adverse Incident. Examples of which being listed at Appendix 7 and at Appendix 8. 9

11 4.2.4 All incidents graded as Extreme or High will be notified to the Corporate Risk Manager on the day of its occurrence A list of incidents which the Trust is required to notify to the Health and Safety Executive under the Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1997 (RIDDOR) is attached as Appendix 9. When a line manager becomes aware of such an incident occurring a copy of the Incident Report Form must be immediately faxed to the Corporate Risk Management at Causeway House, Ballymoney (Fax ) prior to its grading or other processing Managers should identify any external agencies to be notified of the incident. The Northern Health and Social Services Board Untoward Events Policy is found at (Appendix 10) and is followed by a summary of external agencies that may be notified of categories of incidents (Appendix 11) When all of the sections of the Incident Report Form have been completed the white copy will then be forwarded to the Risk Management Department at Causeway House, Ballymoney within 2 working days of the incident occurring. Under no circumstances must the forwarding of an Incident Report Form be delayed information not available within the 2 working days can be forwarded as it becomes available. 4.3 Risk Management Department The Risk Management Department will review all Incident Report Forms on day of receipt. Where necessary forms will be forwarded internally for further action/advice. For example, Medicines Governance Pharmacist, Assistant Director of Estates Services or Back Care/Health and Safety Adviser. Incidents that have to be reported to external agencies by the Trust s named person will be co-ordinated by the Corporate Risk Manager. 5.0 Investigating incidents 5.1 Level of investigations Low and Medium risk events (Green & Yellow) Will not require detailed investigations and should be undertaken swiftly by completion of an After Action Review in the immediate aftermath of an event to establish: What happened? How did what happened vary from what should have or was expected to happen? Why did it happen in that way? Any learning to share with team or wider Trust services? 10

12 5.1.2 High risk events (Purple) Will be investigated by a senior manager (Levels 3 or 4). Many will require only a swift investigation to determine the root causes and may need to be regraded. The report must be presented within 20 working days of the event s occurrence or its occurrence first becoming known Extreme risk events (Red) Will be investigated by a multidisciplinary team led by a Chief Investigating Officer appointed by the responsible Director. The investigation will be done using a Root Cause Analysis methodology. Some investigations for incidents initially graded as High or Extreme can, as the facts become known, be aborted and/or downgraded. The investigation report must be presented within 30 working days, or an extension should be negotiated with the Director and where appropriate the family kept informed Root Cause Analysis is a technique for undertaking a systematic investigation which looks beyond the individuals concerned and seeks to identify and understand the underlying causes and environmental context within which the incident occurred Guidance for completion of an investigation employing Root Cause Analysis methodology is available by accessing the National Patient Safety Agency website - an extract from which is attached as Appendix A recommended model for the drafting of the investigation report is provided within Circular HSS (SQSD) 34/ HSC Regional Template And Guidance For Incident Review Reports a copy of which is attached at Appendix A condensed report template for investigation of less complex incidents, eg a medication error or equipment failure, and which did not have serious consequences can be downloaded from the National Patient Safety Agency website as noted above. This template together with a supporting Contributory Factor Classification Framework is also attached as Appendix It is recognised that not all safety incidents resulting in Major or Catastrophic harm result from any human or system failure. In such cases the line manager notified of the incident should satisfy themselves that there is no need to progress to a full root cause analysis by considering the information available about the event and asking the following simple questions to ascertain if any of the following factors contributed to the outcome of the incident: 11

13 Was there anything about the task/procedure involved? Was there anything about the way that the team works together or perceives each other s roles? Was there anything about the equipment involved? Was there anything related to the working environment or conditions of work? Was there anything about the training and education of the staff in relation to their competence to (a) provide the care/service required and (b) manage the incident when it occurred? Was there anything relating to communication systems between individual members of the team, departments, or electronic communications, for example, test results via computer? Was there anything about the availability, or quality of any guidance notes, polices or procedures? Was there anything about the Trust s strategy, its strategic objectives and priorities? 5.3 Providing that all these questions were answered as No then it would not be necessary to investigate further. However, any Yes answers indicates that some degree of root cause analysis of the incident, at least in part, would be required. 5.4 A member of Governance Department staff will participate as a member of all multidisciplinary teams investigating incidents graded Extreme and also, as considered necessary, to the investigation of incidents with lower gradings. 5.5 For many incidents it is important to ascertain not who might have made an error but what factors contributed to create the conditions in which the errors happened? When undertaking the investigation the Investigating Officer should seek to identify the root causes 6.0 Feedback, review and monitoring arrangements 6.1 Following completion of an Incident Report Form the staff concerned must receive an acknowledgement from their line manager. 6.2 The line manager must ensure that their staff are kept fully informed throughout any investigation process and/or completion of any remedial actions taken. 6.3 All reported incidents and remedial actions will be collated and analysed by the Corporate Risk Management Department. Statistical reports and analyses will be produced for the appropriate committees as constituted within the Trust s Governance Accountability Framework and also for Directorates as required. 12

14 Part 3 - Management of Serious Adverse Incidents Procedure 1. Objectives 1.1 To facilitate the effective and consistent identification and management of incidents which because of their actual or potential impact and/or implications require to be considered as constituting a Serious Adverse Incident (SAI) and requiring to be notified to the Department of Health and Personal Social Services in accordance with the provisions of Circular HSC (SQS) 10/2007 Reporting and follow-up on serious adverse incidents and reporting of breaches of patients waiting in excess of 12 hours in Emergency Care Departments in the Department of Health, Social Services and Public Safety.. Incidents identified as being an SAI require investigation, analysis and managerial action beyond that normally expected of any incident. 1.2 The process described in this procedure is displayed diagrammatically at Appendix Definition of a Serious Adverse Incident 2.1 A SAI is any incident involving the Trust and its staff, service users or visitors which is out of the ordinary, grossly exceptional and unexpected and which is known or has the potential, subject to further investigation, to: warrant regional action to improve safety or care within the broader HPSS; and/or is of public concern; and/or requires an independent review. 2.2 Whilst incidents of this nature are infrequent they can attract high levels of public or media interest if one or more of the following apply: a large number of service users are involved; there may be question of poor clinical or management judgement; it represents a gross service failure; a service user has died or suffered serious injury under unexpected circumstances and not normally associated with routine clinical procedure; a serious complaint or allegation has been made about a member of staff a procedure has been completed involving wrong patient or wrong body part; failure, malfunction or unavailability of equipment, or its misuse. 13

15 2.3 If in doubt about a patient s deterioration or death being natural or avoidable and consequently whether it should be managed as an adverse incident or not, always manage as an adverse incident until you know otherwise. 2.4 Examples of adverse incidents coming within the definition noted above are attached as Appendix 7 and Appendix Procedure, Process and Responsibilities for Identifying and Processing Serious Adverse Incidents 3.1 All staff To report all incidents as defined in Part 2, regardless of how apparently insignificant or minor, to their line manager in accordance with the Trust s Incident Management Procedure as soon as possible after becoming aware of their occurrence. 3.2 Line Manager Will decide whether or not the incident should be considered as being a Serious Adverse Incident? If yes, or if in doubt contact designated Senior Manager, Director or Corporate Risk Manager for advice and direction as to further action If determined as being a serious adverse incident a copy of the Incident Report Form will be immediately faxed to the Corporate Risk Manager. If not a SAI then forward Incident Report Form through normal channels If the incident involves the death of a service user, member of staff or other person as a result of the Trust s activities, ensure that required arrangements regarding contact with Coroner s Office have been completed If equipment or a medical device is involved ensure that it is removed from use and secured for further inspection or, where a death has occurred, that it remains on the body pending autopsy All relevant notes and records are secured pending further contact from Corporate Risk Management or, where applicable, the PSNI, HSE(NI) or other enforcing authority. 3.3 Director & Medical Director/Executive Director Social Work The Director responsible for the Service in which incident occurred with, as applicable, the Medical Director and relevant clinicians, or Executive Director Social Work and relevant social care practitioners, will decide on whether the incident is to be considered as being an SAI and communicate decision to Corporate Risk Manager within 2 working days. Where the incident has been designated an SAI by DHSSPS eg suicide the reporting can be done directly by a designated senior manager Where determined as being a SAI will identify the membership of the investigation team to be established as described at Part 2 above. 14

16 3.3.3 Subject to the circumstances of the incident the Director will consider the need to adopt a multi-agency approach to that investigation as described in the Memorandum of Understanding Investigating patient or client incidents (Unexpected death or serious untoward harm) as agreed by the Department of Health, Social Services and Public Safety, Police Service for Northern Ireland, the Coroners Service and the Health and Safety Executive (Northern Ireland) in February Consideration will also be required as to whether the nature of the incident might involve a number of either current or former service users and raise potential concerns regarding the standard of care or treatment provided to them? Reference to be made to the Guide to Conducting Patient Service Reviews or Lookback Exercises issued by the Department in 2006 for further information As noted at section 3.6 below, arrangements for completion of the investigation including the requirements both of Departmental guidance on Securing Papers For Future Inquiries Or Case Management Reviews issued on 31 March 2008 (Reference: IM42) and also the Trust s Risk Management Policy and Strategy The Director will also inform the Chief Executive and the Head of Communications and identify which other persons, including relatives or other carers if service user affected, and/or external agencies require to be notified beyond that routinely required and completed following any incident? 3.4 Chief Executive Will communicate occurrence of an SAI, its circumstances and action being taken to the Chairman and Trust Board. 3.5 Corporate Risk Manager Will complete and forward SAI Report (Appendix 15) to the Department of Health, Social Services and Public Safety providing required background information as detailed at Appendix That information requiring to be promptly provided by the Directorate involved so as to allow compliance with the Department s required timescale of notification within 72 hours of occurrence of the incident The completed SAI Notification is copied to the Northern Health and Social Services Board, relevant Director and to Head of Governance and Patient Safety. 3.6 Securing Papers For Independent Inquiries, Case Management Reviews or Inquests Where the incident has been identified at 3.3 above as potentially being the subject of Independent Review or Case Management Review, or of an Inquest, or if subsequently decided, all relevant notes and records will be forwarded to the Corporate Risk Manager for securing pending completion of the investigation or other process. During which period suitable arrangements will be maintained for controlled access to those notes and records as might be required by the operational staff involved. 15

17 Appendix 1 Being Open - communicating with service users and/or their carers Part A - Ten Principles of Being Open 1. Principle of acknowledgement All safety incidents should be acknowledged and reported as soon as they are identified. In cases where the service user and/or their carers inform Trust staff that something untoward has happened, it must be taken seriously from the outset. Any concerns should be treated with compassion and understanding by all healthcare staff. Denial of a service user s concerns will make future open and honest communication more difficult. 2. Principle of truthfulness, timeliness and clarity of communication Information about a patient/client safety incident must be given to service users and/or their carers in a truthful and open manner by an appropriately nominated person. Service users want a step-by-step explanation of what happened, that considers their individual needs and is delivered openly. Communication should also be timely: service users and/or their carers should be provided with information about what happened as soon as practicable. It is also essential that any information given is based solely on the facts known at the time. Trust staff should explain that new information may emerge as an incident investigation is undertaken, and service users and/or their carers should be kept upto-date with the progress of an investigation. Service users and/or their carers should receive clear, unambiguous information and be given a single point of contact for any questions or requests they may have. They should not receive conflicting information from different members of staff. Medical or other jargon, which they may not understand, should be avoided. 3. Principle of apology Service users and/or their carers should receive a sincere expression of sorrow or regret for the harm that has resulted from a patient/client safety incident. This should be in the form of an appropriately worded apology, as early as possible. Both verbal and written apologies should be given. The decision on which staff member should give the apology should consider seniority, relationship to the service user, and experience and expertise in the type of incident that has occurred. Verbal apologies are essential because they allow face-to-face contact between the service user and/or their carers and the health or social care team. This should be given as soon as staff are aware an incident has occurred. It is important not to delay for any reason, including: setting up a more formal multidisciplinary Being Open discussion with the service user and/or their carers, fear and apprehension, or lack of staff availability. Delays are likely to increase the service user s and/or their carer s sense of anxiety, anger or frustration. 16

18 A written apology, which clearly states the Trust is sorry for the suffering and distress resulting from the incident, must also be given. An apology is not an admission of liability 4. Principle of recognising patient and carer expectations Service users and/or their carers can reasonably expect to be fully informed of the issues surrounding a patient/client safety incident and its consequences in a faceto-face meeting. They should be treated sympathetically, with respect and consideration. Confidentiality must be maintained at all times. Service users and/or their carers should also be provided with support in a manner appropriate to their needs. This involves consideration of special circumstances that can include a service user requiring additional support, such as an independent advocate or a translator. When appropriate, information on accessing the Trust s Complaints Department and relevant support groups like Cruse Bereavement Care should be given to the service user/ and or their carers as soon as it is possible. 5. Principle of professional support The Trust operates a Fair and Just Culture, which is described within this document and aims to create an environment in which all staff, whether directly employed or independent contractors, are encouraged to report patient/client safety incidents. Managers should ensure that staff feels supported throughout the incident investigation process as they too may have been traumatised by being involved. They should not be unfairly exposed to punitive disciplinary action, increased medico-legal risk or any threat to their registration. Where there is reason for the Trust to believe a member of staff has committed a punitive or criminal act, the Trust will take steps to preserve its position, and advise the member(s) of staff at an early stage to enable them to obtain separate legal advice and/or representation. Staff will also be encouraged to seek support from relevant professional bodies such as the General Medical Council, Royal Colleges, the Medical Protection Society, the Medical Defence Union and the Nursing and Midwifery Council. 6. Principle of risk management and systems improvement Root cause analysis (RCA) is the tool used to uncover the underlying causes of a patient/client safety incident. Investigations should focus on improving systems of care, which will then be reviewed for their effectiveness. Reports should be compiled and widely circulated in order that the whole organisation can learn from these mistakes and prevent further recurrence. The Corporate Risk Manager and the Risk and Governance Co-ordinating Group together with other groups established within the Trust s Governance Accountability Framework monitor recommendations and actions arising from these reports. The Corporate Risk Manager will also use these instances to trigger further risk assessment across the organisation, providing another opportunity to be pro-active.

19 7. Principle of multidisciplinary responsibility This policy applies to all staff that has key roles in the service user s care. Most Trust health and social care provision involves multidisciplinary teams and communication with service users and/or their carers following an incident that led to harm, should reflect this. This will ensure that the Being Open process is consistent with the philosophy that incidents usually result from systems failures and rarely from the actions of an individual Principle of clinical and social care governance Being Open has the support of patient/client safety and quality improvement processes through the clinical and social care governance framework, in which patient/client safety incidents are investigated and analysed, to find out what can be done to prevent their recurrence. It also involves a system of accountability through the Chief Executive to the Trust Board to ensure these changes are implemented and their effectiveness reviewed. 9. Principle of confidentiality Full respect should be given to the service user s and/or their carer s and staff s privacy and confidentiality. Details of a patient/client safety incident should at all times be considered confidential. The consent of the individual concerned should be sought prior to disclosing information beyond the clinicians involved in treating the patient or social care practitioners involved in the providing care to the client. Where this is not practicable or an individual refuses to consent to the disclosure, disclosure may still be lawful if justified in the public interest or where those investigating the incident have statutory powers for obtaining information. Communications with parties outside of the clinical or social care team should also be on a strictly need-to-know basis and, where practicable, records should be anonymous. In addition, it is good practice to inform the service user and/or their carers about who will be involved in the investigation before it takes place and give them the opportunity to raise any objections. 10. Principle of continuity of care Service users are entitled to expect they will continue to receive all usual health and social care provision and continue to be treated with respect and compassion. If a service user expresses a preference for their needs to be taken over by another team, the appropriate arrangements should be made for them to receive provision elsewhere. Part B - Content of Being Open discussions To include: Service user and/ or their carers to be informed of the identify and role of all people attending the discussion before it takes place. This is to allow them the opportunity to state their own preferences about which staff should be present. There should be an expression of genuine sympathy, regret and an apology for the harm which has been caused. 18

20 The facts that are known are agreed by the multi-disciplinary team. Where there is disagreement, communication about these events should be deferred until after the investigation has been completed. The service user and/or their carers should be informed that an incident investigation is being carried out and more information will be made available as it progresses. It should be made clear to the service user/and or their carers that new facts may emerge as the incident investigation proceeds. The service user/and or their carer s understanding of what happened should be taken into consideration, as well as any questions they may have. There should be consideration and formal noting of the service user s and/or their carer s views and concerns, and demonstrate that these are being listened to and taken seriously. Appropriate language and terminology should be used when speaking to service users and/or their carers. The need to engage an interpreter or other specialist communicator, eg Makaton or Sign, should be considered where necessary for the assistance of the service user and/or their carers. An explanation should be given to what will happen next in terms of the long term treatment or care plan and of the incident investigation findings. Information on likely short and long term effects of the incident (if known) should be shared. The latter may have to be delayed to a subsequent meeting by which time the situation may have become clearer. An offer of practical and emotional support should be made to the service use and/or their carers. This may involve getting help from third parties such as charities and voluntary organisations as well as offering more direct assistance. Information about the service user and/or their carers should not normally to third parties without the necessary consent having first being obtained. It should be recognised that service users and/or their carers may be anxious, angry and frustrated even when the being open meeting(s) is conducted appropriately. All details of the incident must be fully documented in a timely, complete and accurate manner. Details regarding the subsequent management the service user s care must be fully documented in their notes and records. 19

21 Forms of support to be provided to staff by the Trust during management and investigation of a serious clinical or social care incident Appendix 2 Facilitating the formal and informal debrief of the clinical or social care team involved in the incident, including the provision of bringing in extra staff to cover shifts where appropriate. This being done as part of the support system and separate from the requirement that staff may not be available whilst providing statements for any ongoing investigative process. The team also potentially benefiting from individual feedback about the final outcome of that investigation. Providing opportunities within working hours for staff, whether involved in either the investigation or service user/carer communication processes, to discuss their involvement and/or the circumstances leading up to the incident and what they are going to say? Providing advice and training on the management of incidents, including the need for practical, social and psychological support, as part of a general training programme for all staff in clinical and social care risk management and safety. Providing information on the support systems currently available for staff distressed by safety incidents. This including counselling services offered by professional bodies, stress management courses and mentoring for staff who may be assuming a leadership role in relation to investigation and service user/carers communication processes. Also Occupational Health Services, Carecall or hospital chaplains. 20

22 Appendix 3 Procedure for recording and reporting incidents Step # From Part 2 Of Procedure 1 & Incident occurs Immediate management of incident by staff present / line manager. Incident Report Form completed by Staff Member involved in incident and forwarded to Line Manager. If thought to be a Serious Adverse Incident Line Manager or Director contacted. Timescale During same shift or on same day Immediately & Line Manager enters any outstanding information onto Incident Report Form. Risk grades the incident and if Extreme or High notifies Corporate Risk Manager Subject to nature of the incident or based on risk grading considers whether it is a Serious Adverse Incident? If incident requires RIDDOR reporting, fax Incident Report Form to Causeway House. Undertakes an After Action Review for Low and Moderate Risk Events. Completes Incident Report Form and forwards to Causeway House. On same day as incident occurred Immediately Within 2 working days of incident occurring 4.3 Incident Report Forms received and processed by Corporate Risk Management at Causeway House on day of receipt 6.0 Investigation of incidents rated High and Extreme commissioned by the Director for reporting within 30 and 20 days respectively. Part 3 Decision on SAI within 2 working days and processed as per Part 3 of procedure 21

23 Appendix 4 Actions and responsibilities for all staff in the event of an incident occurring Responsibilities of staff involved: Report all incidents immediately to line manager. Ensure that medical attention or treatment is obtained if required. Take any immediate action required to make the area safe, eg isolating spillages. Secure and retain any equipment involved and tag with label. Equipment must be left exactly as it was at the time of the incident, including on the patient s body where applicable, and no adjustments or Interventions must be made unless required for safety reasons pending further direction. Retain any medication and packaging involved. Secure and retain any documentation relating to the incident. Where the incident involves a service user, record details in their notes and records including remedial treatment and aftercare. Notes and records should then be secured with no further updating. Complete an Incident Report Form immediately for each person involved in the incident. When multiple incidents occur with the same service user in the same day an Incident Report Form Continuation Sheet (form to follow) will be completed and attached to the Incident Report Form completed following the first incident of that shift or day. Responsibilities of Line Managers Ensure that all sections of the Incident Report Form have been fully completed and forward to the Corporate Risk Management within two working days. Risk grading the incident to identify level of further investigation required. Identify if a Serious Adverse Incident or RIDDOR and communicate accordingly. Contact the police where incident has involved malicious damage, theft or violence with the attending officer s name, rank, number and station to be recorded on the Incident Report Form. Arrange for the member of staff involved in or affected by the incident to receive the necessary support and assistance including referral to an Accident and Emergency Department, the Trust s Occupational Health Department and/or Carecall as required. Communicate incident to service user in most appropriate way (refer Appendix 1). 22

24 Appendix 5 Trust Incident Report form (to follow) 23

25 Appendix 6 PROCEDURE FOR IDENTIFYING & PROCESSING SERIOUS ADVERSE INCIDENTS Incident occurs Yes/possibly? (Examples overleaf) Does it meet DHSSPS SAI criteria? 1 No Complete Trust Incident Report Form. Complete Trust Incident Report Form Fax Governance copy to CRM and If medical device/ equipment involved secure for inspection or if incident is associated with death, leave devices on body for post mortem. Telephone senior management with details and further advice. Consider need to: *refer to coroner & *secure all records *apply Being Open Principles and if, Memorandum of Understanding applies. Follow Trust s Incident Reporting procedure. CRM informs DHSSPS & other external agencies as appropriate. 3 Director with appropriate Executive Director advise SAI status & inform CRM s 2 office within 2 working days. Inform Chief Executive as necessary. Director(s) consider rating of incident & membership of investigation team. Red rated incidents should have a member/ chair independent of service team and include senior governance representative. Investigation report copied to Director, Medical Director & CRM. CRM forwards report to DHSSPS & copies to Head of Governance & Patient Safety. Head of Governance & Patient Safety identifies corporate learning & puts on to appropriate governance agenda. 1.DHSSPS for SAI * resulted in death * regional learning * media interest ref to trigger list 2. CRM, Corporate Risk Manager, Alex Lynch Tel: Other agencies including: MHC Mental Health Commission NIAC re error using or in equipment/ medical devices RQIA regulated services other NHSSB Northern Health and Social Services Board 24

26 Trigger List for Possible SAI s It is not possible to give a definite list of events which can be regarded as serious adverse incidents nor is it possible to develop criteria which eliminate the need to exercise judgement. All incidents which result in or could have resulted in serious harm should be thoroughly investigated, regardless of whether they meet the DHSS&PS SAI criteria or not. If in doubt about reporting under SAI criteria there is safety in reporting and withdrawing it later when more is understood about the circumstances of the event. The following events will almost always be reported under the SAI procedure. sudden unexpected death or suicide of any person, on or off Trust premises, currently in receipt of mental health services from the Trust, or who has been discharged from mental health services within last 12 months, including where the person is subject to the Mental Health Order. wrong patient/wrong operation site, wrong patient imaged, wrong procedure performed. foreign body left unintended in-situ. performance of unplanned, unconsented procedures, eg removal of ovaries at Hysterectomy. accidental injury to baby during caesarean section. maternal deaths. stillbirths of previous healthy foetus and any intrapartum event which is likely to result in lasting impairment. Any infant/child death in hospital or community. death or serious harm as a result of medicines prescribing, dispensing or administration errors. excessive radiation exposures death or injury where foul play is suspected. serious breaches of confidentiality or of information governance requirements. referrals of the Juvenile Justice System. placement of an under 18 year old in an adult learning disability or adult mental health facility due to unavailability of age-appropriate services. serious criminal acts by patients, clients or staff. serious physical attacks on staff. Significant legal proceedings, eg Judicial Reviews, Inquests, High Court hearings of medical negligence actions. 25

27 If any of the following events result in significant harm and/or may be associated with system failures in the Trust, the need to report as an SAI should be considered. any incident which causes clinical concern. late or misdiagnoses including unreported significant imaging findings. failure to record/act on significantly abnormal results. equipment malfunction/failure/unavailability or user error during a procedure. falls leading to serious injury or other harm. failed procedures, eg sterilisation, laparoscopy. babies born with an abnormality not been previously diagnosed or with significant shoulder dystocia and/or Erbs Palsy. surgical injury to mother causing accidental damage to, bladder or bowel. deviation from accepted procedures. requirement for additional intervention/extended hospital stay serious consequences for the patient because of failure in diagnostic processes or other untoward/unplanned event whilst receiving care vulnerable adult abuse occurring in Trust services. 26

28 Appendix 7 2. Risk Grading System Instructions for use 1. Identify the risk 2. Using Table 1 identify the Impact/Consequences should the risk occur and select number from scale 3. Using Table 2 identify the Frequency/Likelihood or immediacy of the risk occurring and select number from scale 4. Impact/Consequences Score X Frequency/Likelihood Score = Risk Grading as described in Risk Grading Matrix (Low, Moderate, High or Extreme) Table 1 Impact/Consequences Descriptors and Scores Descriptors Insignificant Minor Moderate Major Catastrophic Safety (Patients, Clients, Staff & Public) Minor injury or illness requiring minor intervention. Absence from work < 3 days Minimal injury requiring no/minimal intervention or treatment. No absence from work. Moderate injury or illness requiring extended stay in hospital or care/ professional intervention or absence from work > 3 days. RIDDOR reportable and/or other external agency. Potential health and safety prosecution. Death or still birth. Major injury and/or long term/ permanent incapacity/ disability (loss of limb). Delay in diagnosis and/or commencement of patient/client care with long term affects > 3 months). Major outbreak. Premature retirement from work. RIDDOR or/ other external agency notification. Potential Corporate Manslaughter prosecution. Other health and safety prosecution. Multiple deaths, still births or permanent incapacity/ disability requiring life-long care (brain damaged adults or babies),reportable to RIDDOR and/or other external agency. Corporate Manslaughter prosecution. Performance (Objectives/ Targets/ Budgets) Insignificant cost increase/schedule slippage. No noticeable reduction in scope or quality 1% off planned activity targets. Failure to meet PfA or other target or objective for 1 quarter. Less than 5% over 2% - 4% off planned activity targets. Failure by meet PfA or other target or objective for 2 quarters. 5 10% off planned activity targets. Failure to meet PfA or other targets or objective for > two consecutive quarters % over budget/ >10% off planned activity targets. Failure by more than 25% to meet Regional and/or local targets or 27

29 Descriptors Insignificant Minor Moderate Major Catastrophic budget/ schedule slippage. 10% over budget/ schedule slippage. Service Quality (Complaints/ Service User Experience/ Inspection/ Audit/ Statutory Compliance/ Quality and Professional Standards/ Staffing Competence) Finance (Claims & Losses) Service/ Business Interruption Locally resolved complaint. Unsatisfactory experience not directly related to care or treatment. Small number of recommendations which focus on minor quality or safety improvement issues. Minor noncompliances advice given. Short term low staffing levels which reduces or disrupts service provision or quality for not more than 1 day. Litigation unlikely. Damage/loss of assets/personal property < 5,000 Loss/ interruption > 1 hour Justified complaint peripheral to clinical or social care. Unsatisfactory experience readily resolvable. Recommendations made which can be addressed by low level of management action. Reduced rating if not resolved. Single non-compliance with, or to follow internal standards, policy or protocols. Ongoing low staffing level reduces service provision or quality. Minor error due to ineffective or inadequate training or implementation of training. Litigation likely. Damage/loss of assets/personal property. > 5000 < 50,000 Loss/interruption > 8 hours Justified complaint involving lack of appropriate clinical or social care. Delay in diagnosis and/or commencement of care or treatment. Repeated noncompliance with, or to follow internal standards, policy or protocols. Challenging recommendations. Reduce rating following next assessment. Late delivery of key objective/service due to lack of staff. Moderate error due to ineffective or inadequate training or implementation of training. Litigation possible. Damage/loss of assets/personal property. > 50,000 < 250,000 Loss/ Interruption > 1 day schedule slippage. Secondary objectives not met. Multiple justified complaints. Serious delay in diagnosis and/or commencement of care or treatment. Major non-compliance with standards, policy or protocol. Enforcement action against Trust. Critical report and low rating of compliance. Very challenging recommendations. Failure to meet national/professional standards. Uncertain delivery of key objective/service due to lack of staff. Major error due to ineffective or inadequate training or implementation of training. Litigation probable. Damage/ loss of assets/personal property. > 250,000 < 1M Loss/ interruption > 7 days objectives. More than 25% over budget/ schedule slippage. Primary objectives not met. Totally unsatisfactory outcome of experience. Significant noncompliance. Prosecution. Zero rating. Severely critical report. Gross failure to meet national/professional standards. Non-delivery/cessation of service due to lack of staff. Loss of key staff. Catastrophic error due to ineffective or inadequate training or implementation of training. Substantial litigation involving one or more claimants probable. Damage/loss of assets/personal property. > 1M Permanent loss of service or facility 28

30 Descriptors Insignificant Minor Moderate Major Catastrophic Adverse Publicity/ Reputation Rumours Local media - shortterm interest. Little affect on staff morale Local media long term interest. Public confidence affected. Significant affect on staff morale Regional media - < 3 days interest. MLA concern (Questions in Assembly). Service well below reasonable public expectation. Use of services affected. National adverse media and/or local media > 3 days. Interest MP and/or MLA concern (Questions in House or Assembly) Total loss of public confidence. Public Enquiry. Environment Nuisance release On site release contained by Trust Additional Guidance For example Drug error with no apparent adverse outcome Grade 1 Pressure Ulcer Off site release contained by Trust Increased length of stay due to HCAI < 1 week. Grade 2/3 Pressure Ulcer Release affecting minimal off-site area requiring external assistance, eg fire service or Radiation Protection Service Increased length of stay due to HCAI > 1 week. Grade 4 Pressure Ulcer. Retained instrument after surgery requiring further intervention. Suspected suicide of a patient with mental health problems and known to Trust. Toxic release with detrimental effect requiring external assistance Unexpected/ unexplained death. Homicide committed by patient known to Trust with mental health problems. Removal of wrong body part leading to death or permanent incapacity. Risks that have been identified as having an Impact/Consequences assessed as being Major or Catastrophic will require consideration by the Director responsible for the service in which the risk has been identified with, as applicable, the Medical Director or Executive Director Social Work regarding notification to the Department of Health etc as a Serious Adverse Incident and or High risk and a decision regarding further management communicated to the Corporate Risk Manager within 2 working days of the incident s occurrence, or of its occurrence becoming known. (Trust Incident Management Policy and Procedure (including procedure for Serious Adverse Incidents refers). 29

31 3. Responsibility for the management of risk Table 2 - Frequency/Likelihood Descriptors The descriptors for each frequency/likelihood (indicators in brackets, of which that considered most relevant to the service area in which the incident has occurred is to be used, are as follows: Descriptor Frequency/ Likelihood Rare Unlikely Possible Likely Almost Certain Remote possibility (1 in 100,000 chance or once every 5 years or more) Could happen but rare (1 in 10,000 chance or typically once a year) Could happen occasionally (1 in 1,000 chance or on average monthly) Could happen often (1 in 100 chance or on average once a week or more frequently) Could happen frequently (1 in 10 chance or once a day or more) Table 3 Risk Grading Matrix Likelihood X Impact = Risk Grading Likelihood /Frequency Impact / Consequences Insignificant Minor Moderate Major Catastrophic Almost certain Likely Possible Unlikely Rare Table 4 Risk Grading Bands LOW MEDIUM HIGH EXTREME 30

32 Appendix 8 Template Title Page Date of Incident / Event Organisation s Unique Identifier (for tracking purposes) 31

33 Introduction The introduction should outline the purpose of the report and include details of the commissioning Executive or Trust Committee. Team Membership List names and designation of the member of the Investigation team. Investigation teams should be multidisciplinary and should have an independent chair. The degree of independence of the membership of the team needs careful consideration and depends on the severity / sensitivity of the incident. However, best practice would indicate that investigation / review teams should incorporate at least one informed professional from another area of practice, best practice would also indicate that the chair of the team should be appointed from outside the area of practice. In the case of more high impact incidents (i.e. categorised as catastrophic or major) inclusion of lay / patient / service user or carer representative should be considered. There may be specific guidance for certain categories of adverse incidents, such as, the Mental Health Commission guidance Terms of Reference of Investigation / Review Team The following is a sample list of statements of purpose that should be included in the terms of reference: To undertake an initial investigation / review of the incident To consider any other relevant factors raised by the incident To agree the remit of the investigation / review To review the outcome of the investigation / review, agreeing recommendations, actions and lessons learned To ensure sensitivity to the needs of the patient / service user / carer / family member, where appropriate Methodology to be used should be agreed at the outset and kept under regular review throughout the course of the investigation. Clear documentation should be made of the time-line for completion of the work. 32

34 This list is not exhaustive Summary of Incident / Case Write a summary of the incident including consequences. The following can provide a useful focus but please not this section is not solely a chronology of events Brief factual description of the adverse incident People, equipment and circumstances involved Any intervention / immediate action taken to reduce consequences Chronology of events Relevant past history Outcome / consequences / action taken This list is not exhaustive Methodology for Investigation This section should provide an outline of the methods used to gather information within the investigation process. The NPSA s Seven Steps to Patient Safety is a useful guide for deciding on methodology. Review of patient / service user records (if available) Review of staff / witness statements (if available) Interviews with relevant staff concerned e.g. o Organisation-wide o Directorate Team o Ward / Team Managers and front line staff o Other staff involved o Other professionals (including Primary Care) Specific reports requested from and provided by staff Engagement with patients / service users / carers / family members Review of Trust and local departmental policies and procedures 33

35 Review of documentation e.g. consent form(s), risk assessments, care plan(s), training records, service / maintenance records, including specific reports requested from and provided by staff etc. This list is not exhaustive 34

36 Analysis This section should clearly outline how the information has been analysed so that it is clear ho conclusions have been arrived at from the raw data, events and treatment / care provided. Analysis can include the use of root cause and other analysis techniques such as fault tree analysis, etc. The section below is a useful guide particularly when root cause techniques are used. It is based on the NPSA s Seven Steps to Patient Safety and Root Cause Analysis Toolkit. (i) Care Delivery Problems (CDP) and / or Service Delivery Problems (SDP) Identified CDP is a problems related to the direct provision of care, usually actions or omissions by staff (active failures) or absence of guidance to enable action to take place (latent failure) e.g. failure to monitor, observe or act; incorrect (with hindsight) decision, NOT seeking help when necessary. SDP are acts and omissions identified during the analysis of incident not associated with direct care provision. They are generally associated with decisions, procedures and systems that are part of the whole process of service delivery e.g. failure to undertake risk assessment, equipment failure. (i) Contributory Factors Record the influencing factors that have been identified as root causes or fundamental issues. Individual Factor Team and Social Factors Communication Factors Task Factors Education and Training Factors Equipment and Resource Factors Working Condition Factors Organisational and Management Factors Patient / Client Factors This list is not exhaustive 35

37 As a framework for organising the contributory factor investigated and recorded the table in the NPSA s Seven Steps to Patient Safety document (and associated Root Cause Analysis Toolkit) is useful. table 36

38 Where appropriate and where possible careful consideration should be made to facilitate the involvement of patients / service users / carers / family members within this process. Conclusions Following analysis identified above, list issues that need to be addressed. Include discussion of good practice identified as well as actions to be taken. Where appropriate include details of any ongoing engagement / contact with family members of carers. Involvement with Patients / Service Users / Carers and Family Members Where possible and appropriate careful consideration should be made to facilitate the involvement of patients / service users / carers / family members. Recommendations List the improvement strategies or recommendations for addressing the issues above. Recommendations should be grouped into the following headings and cross-referenced to the relevant conclusions. Recommendations should be graded to take account of the strengths and weaknesses of the proposed improvement strategies / actions. Local recommendations Regional recommendations National recommendations Learning In this final section it is important that any learning is clearly identified. Reports should indicate to whom learning should be communicated and copied to the Committee with responsibility for governance. 37

39 NPSA Contributory Factor Classification Framework Individual Factors Individual Factors Physical Issues Psychological issues Social Domestic Personality Issues Components General Health (e.g. nutrition, diet, exercise, fitness) Physical disability (e.g. eyesight problems, dyslexia) Fatigue Stress (e.g. distraction / preoccupation) Specific mental health illness (e.g. Depression) Mental impairment (e.g. illness, drugs, alcohol, pain) Motivation (e.g. boredom, complacency, low job satisfaction) Cognitive factors (e.g. attention deficit, distraction, preoccupation, overload and boredom) Domestic / lifestyle problems Low self confidence / over confidence Gregarious / interactive, reclusive Risk averse / risk taker Team and Social Factors Team Factors Components Role Congruence Is there parity of understanding Are role definitions correctly understood Are roles clearly defined Leadership Is there effective leadership clinically Is there effective leadership managerially Can the leader lead Are leadership responsibilities clear and understood Is the leader respected Support and cultural factors Are there support networks for staff Team reaction to patient safety incidents Team reaction to conflict Team reaction to newcomers Team openness 38

40 Communication Factors Communication Factors Verbal communication Written communication Non verbal communication Components Verbal commands / directions unambiguous Tone of voice and style of delivery appropriate to situation Correct use of language Made to appropriate person(s) Recognised communication channels used (e.g. head of service) Are records easy to read Are all relevant records complete and contemporaneous (e.g. availability of patient management plans, patient risk assessments, etc) Are memo s circulated to all members of team Are communications directed to the right people Body Language issues (closed, open, aggressive, relaxed, stern faced) Task Factors Task Factors Guidelines Procedures and Policies Decision making aids Procedural or Task Design Components Up to date Available at appropriate location (e.g. accessible when needed) Understandable / useable Relevant; clear; unambiguous; correct; content; simple Outdated; unavailable/missing; unrealistic Adhered to / followed Appropriately targeted (e.g. aimed at right audience) Availability of such aids e.g. CTG machine, risk assessment tool, fax machine to enable remote assessment of results Access or senior / specialist advice Easy access flow charts and diagrams Complete information test results, informant history Do the guidelines enable one to carry out the task in a timely manner Do staff agree with the task/procedure design Are the stages of the task such that each step can realistically be carried out 39

41 Education and Training Factors Education and Components Training Competence Adequacy of knowledge Adequacy of skills Length of experience Quality of experience Task familiarity Testing and Assessment Supervision Adequacy of supervision Availability of mentorship Adequacy of mentorship Availability/ accessibility On the job training Emergency training Team training Core skills training Refresher courses Appropriateness Content Target audience Style of delivery Time of day provided Equipment and Resources Factors Equipment Components Displays Correct information Consistent and clear information Legible information Appropriate feedback No interference Integrity Good working order Appropriate size Trustworthy Effective safety features Good maintenance programme Positioning Correctly placed for use Correctly stored Usability Clear controls User manual Familiar equipment New equipment Standardisation 40

42 Working Conditions Work Environment Component Factor Administrative factors The general efficiency of administrative systems e.g. reliability Systems for requesting medical records Systems for ordering drugs Reliability of administrative support Design of physical environment Office design: computer chairs, height of tables, antiglare screens, security screens, panic buttons, placing of filing cabinets, storage facilities, etc Area design: length, shape, visibility, cramped, spacious Environment Housekeeping issues cleanliness Temperature Lighting Noise levels Staffing Skill mix Staff to patient ratio Workload / dependency assessment Leadership Use temporary staff Retention of staff / staff turnover Work load and hours of work Shift related fatigue Breaks during work hours Staff to patient ratio Extraneous tasks Social relaxation, rest and recuperation Time Delays caused by system failure or design Time pressure Organisational and Strategic Factors Organisational Components Factor Organisational structure Hierarchial structure, not conducive to discussion, problem sharing, etc Tight boundaries for accountability and responsibility Clinical versus the managerial model Priorities Safety driven External assessment driven e.g. Star Ratings Financial balance focused Externally imported risks Locum / Agency policy and usage Contractors Equipment loan PFI 41

43 Safety culture Safety / efficiency balance Rule compliance Terms and Conditions of Contracts Leadership example (e.g. visible evidence of commitment to safety) Patient Factors Patient Factors Components Clinical condition Pre-existing co-morbidity Complexity of condition Seriousness of condition Treatability Social factors Culture / religious beliefs Life style (smoking / drinking / drugs / diet) Language Living accommodation (e.g. dilapidated) Support networks Physical factors Physical state malnourished, poor sleep pattern, etc Mental / psychological factors Motivation (agenda, incentive) Stress (family pressures, financial pressures) Existing mental health disorder Trauma Interpersonal relationships Staff to patient and patient to staff Patient to patient Inter family siblings, parents, children 42

44 Patient Safety Investigation Report Summary Incident Description and Consequences Incident type: Specialty: Effect on patient: Severity: Scope and Level of Investigation Level of investigation - concise Medication incident Involvement and support of Patient and Relatives From the patient notes: Chronology of events - Notable Practise Care and Service Delivery Problems (Themed and prioritised) CDPs: SDPs: Contributory Factors Individual Team Factors: Communication Factors: Task Factors: Education/Training Factors: Equipment/Resource Factors: Working condition: Organisational/Srategic Factors: Patient Factors: Root Causes Lessons Learned Recommendations Action Plan - see table overleaf Implementation, monitoring and evaluation arrangements Arrangements for sharing and learning Author Date 43

45 Chronology of events Date & Time Event Action Plan Example Incident No: Action 1 Action 2 Action 3 Root CAUSE As per investigative report EFFECT on patient/service Recommendation(s) to address root cause (Or rationale, if no action or recommendation is set) As per investigation report Action(s) to achieve recommendations Level for action Implementation by whom:- Implementation by when:- Resource required (time) Resource required (money Resource required (other) Evidence of completion Monitoring and evaluation arrangements Sign-off by:- 44

46 Information Governance Incidents Definition Appendix 9 Would include incidents or near misses in the following areas: Breaches of confidentiality (eg inappropriate sharing of information with a relative or others) Lost/missing records held in paper files, Information Systems or on portable devices (eg lost memory sticks) Inappropriate access to records/information (eg files inappropriately stored; stores inappropriately accessed; network/system security breached; passwords inappropriately shared) Inappropriate record keeping in relation to content or medium (eg use of unprotected PDAs for patient information; inadequate detail in records; inappropriate use of abbreviations) Information/records not available or accessible when needed (eg misplaced files; system downtime with no contingency in place) Information/records incorrectly analysed/interpreted (eg as a result of software problems or incorrectly constructed queries) Records incorrectly collated or not linked/cross reference when they should have been (eg incorrect merges; records confused as a result of H+C No) Inappropriate disclosure of information/information withheld when it should have been released when requested under legislation Inappropriate destruction/retention of records Trust information inappropriately re-used (ie without licence as required by the Reuse of Public Sector Information legislation 45