Being Open Policy Document No. EDRMS000102NC Version No. 1.0 replaces version 7 Approved by Clinical PAG Date approved 24/10/2012 Ratified by Patient Safety and Date ratified Quality Committee 05/07/2012 Date Implemented 29/10/2012 05/07/2014 Next Review Date Status Approved Target Audience All Staff Accountable Director Medical Director Policy Author/Originator Clinical Risk Manager Implementation Lead Clinical Risk Manager If developed in partnership with another agency, ratification details of the relevant agency Document Title: Being Open Policy Equality Impact Great Western Hospitals NHS Foundation Trust (‘GWH’) strives to ensure equality of opportunity for all service users, local people and the workforce. As an employer and a provider of health care, GWH aims to ensure that none are placed at a disadvantage as a result of its policies and procedures. This document has therefore been equality impact assessed in line with current legislation to ensure fairness and consistency for all those covered by it regardless of their individuality. This means all our services are accessible, appropriate and sensitive to the needs of the individual. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 2 of 31 Document Title: Being Open Policy Contents 1 Document definition ....................................................................................... 5 1.1 Introduction .................................................................................................... 5 1.2 References & Further Reading ....................................................................... 5 1.3 Glossary / Definitions ..................................................................................... 6 1.4 Purpose ......................................................................................................... 8 1.5 Scope............................................................................................................. 9 1.6 Regulatory Position ........................................................................................ 9 1.7 Special Cases ................................................................................................ 9 1.8 Comments...................................................................................................... 9 2 Roles and Responsibilities ........................................................................... 10 3 Introduction .................................................................................................. 12 3.1 The principles of Being Open ....................................................................... 13 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 Acknowledgement ..........................................................................................13 Truthfulness, timeliness and clarity of communication. ..................................13 Apology ...........................................................................................................13 Recognising patient and carer expectations. .................................................14 Professional support. ......................................................................................14 Risk management and systems improvement. ..............................................14 Multidisciplinary responsibility. .......................................................................14 Clinical governance. .......................................................................................15 Confidentiality. ................................................................................................15 Continuity of care ............................................................................................15 4 Being Open Advisors ................................................................................... 15 5 Being Open Process .................................................................................... 16 5.1 Stage 1: Incident detection or recognition .................................................... 16 5.1.1 5.1.2 5.2 Patient Safety incidents which have occurred elsewhere ..............................17 Initial assessment to determine level of response .........................................17 Stage 2: Preliminary team discussion........................................................... 18 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 Timing .............................................................................................................18 Choosing the individual to communicate with the patients, their families and carers ........................................................................................................................18 Assistance with the initial Being Open discussion .........................................19 Responsibility of junior healthcare professionals ...........................................19 Involving the healthcare staff who made mistakes .........................................19 5.3 Stage 3: Initial Being Open discussions ....................................................... 20 5.4 Stage 4: Follow-up discussions .................................................................... 21 5.5 Stage 5: Process completion ........................................................................ 21 5.5.1 5.5.2 5.6 Communication with the patient, their family and carers ................................21 Continuity of care ............................................................................................21 Documentation ............................................................................................. 22 6 Patient issues to consider ............................................................................ 23 6.1 Communication ............................................................................................ 23 6.2 Advocacy and support .................................................................................. 24 6.3 Particular patient circumstances................................................................... 24 6.3.1 When a patient dies ........................................................................................24 Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 3 of 31 Document Title: Being Open Policy 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.3.8 7 Children ..........................................................................................................24 Patients with mental health issues .................................................................25 Patients with cognitive impairment .................................................................25 Patients with learning disabilities ....................................................................25 Patients with a different language or cultural considerations .........................25 Patients with different communication needs .................................................26 Patients who do not agree with the information provided ..............................26 Supporting staff ............................................................................................ 26 7.1 Training support ........................................................................................... 26 7.2 Monitoring .................................................................................................... 28 Appendix A – Quick reference guide to Being Open ....................................................................... 30 Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 4 of 31 Document Title: Being Open Policy 1 1.1 Document definition Introduction Being Open is a set of principles that healthcare staff should use when communicating with patients, their families and carers following a patient safety incident in which a patient has been harmed. 1.2 References & Further Reading Ref. No. Document Title Document Location 1 NPSA – Being Open – Communicating Patient http://www.nrls.npsa.nhs.uk/resources/? Safety Incidents With Patients And Their Carers entryid45=65077 2 Confidentiality: NHS Code of Practice www.connectingforhealth.nhs.uk/system sandservices/infogov/codes 3 Records Management: NHS Code of Practice www.dh.gov.uk/en/Publicationsandstatis tics/Publications/PublicationsPolicyAnd Guidance/DH_4131747 5 Code of Practice on Openness in the NHS www.dh.gov.uk/en/Publicationsandstatis tics/Publications/PublicationsPolicyAnd Guidance/DH_4050490 6 Health Service Circular – Caldicott Guardians, HSC 1999/012 www.dh.gov.uk/en/Publicationsandstatis tics/Lettersandcirculars/Healthservicecir culars/DH_4004311 7 Health Service Circular – Data Protection Act 1998: Protection and use of patient information www.dh.gov.uk/en/Publicationsandstatis tics/Lettersandcirculars/Healthservicecir culars/DH_4002964 8 Use and Disclosure of Health Data (Guidance on the application of the Data Protection Act 1998) www.ico.gov.uk 9 Medical Defence Union. MDU encourages doctors to say sorry if things go wrong. MDU, May 2009 http://www.themdu.com/Search/hidden_Article.asp?art icleID=1982&contentType=Media%20rel ease&articleTitle=MDU+encourages+do ctors+to+say+sorry+if+things+go+wrong &userType= 10 NHS Litigation Authority. Apologies and Explanations. NHSLA, London. May 2009 http://www.nhsla.com/NR/rdonlyres/00F 14BA6-0621-4A23-B885FA18326FF745/0/ApologiesandExplana tions.pdf 11 Welsh Risk Pool. Technical Note 23: Apologies and Explanations. WRP, July 2001. http://howis.wales.nhs.uk/sites3/docmet adata.cfm?orgid=287&id=71076 12 Incident Management Policy Trust Intranet 13 Whistle Blowing Policy Trust Intranet 14 Data Protection Policy Trust Intranet Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 5 of 31 Document Title: Being Open Policy Ref. No. Document Title Document Location 15 Code of Confidentiality for Employees in Respect of Confidentiality, 2GEN-POL-025 Trust Intranet 16 Information Disclosure Policy Trust Intranet 18 Information Security Incident Reporting Procedure, 2ITD-PRD-001 Trust Intranet 19 Your Health Record – Protecting Your Information, Avon NHS IM&T Consortium Trust Intranet 20 Information Sharing Principles, Avon NHS IM&T Trust Intranet Consortium 21 The Caldicott Principles, 4ITD-LFT-001 1.3 Trust Intranet Glossary / Definitions The following acronyms and abbreviations are used within the document: AvMA Action Against Medical Accidents CHC Community Health Councils CNST Clinical Negligence Scheme for Trusts eForm Electronic form used to submit reports to the NRLS GMC General Medical Council ICAS Independent Complaints Advocacy Services IDT Incident Decision Tree MDU Medical Defence Union MORI Market and Opinion Research International MPS Medical Protection Society NHSLA National Health Service Litigation Authority NPSA National Patient Safety Agency NRLS National Reporting and Learning System PALS Patient Advisory and Liaison Service RCA Root cause analysis RPST Risk Pooling Schemes for Trusts SI Serious Incident WRP Welsh Risk Pool The following definitions are used within the document: Adverse event See ‘Patient safety incident’. Anonymous Information that has had patient identifiable features removed; without making the information of no use for its purposes. Apology A sincere expression of regret offered for harm sustained. Being open Open communication of patient safety incidents that resulted in moderate harm, severe harm or death of a patient while receiving healthcare. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 6 of 31 Document Title: Being Open Policy Carers Family, friends or those who care for the patient. The patient has consented to their being informed of their confidential information and to their involvement in any decisions about their care. Clinical governance A framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish. Clinical risk manager An officer within a trust assigned primary coordination responsibility for issues of clinical risk management. See Risk management. Harm Injury (physical or psychological), disease, suffering, disability or death. Healthcare professional Doctor, dentist, nurse, pharmacist, optometrist, allied healthcare professional, or registered alternative healthcare practitioner. Healthcare organisation Organisations that provide a service to individuals or communities to promote, maintain, monitor or restore health. See also ‘NHS organisation’. Injury Damage to tissues caused by an agent or circumstance. Intentional unsafe acts Incidents resulting from a criminal act, a purposefully unsafe act, or an act related to alcohol/substance abuse by a care provider. These are dealt with through performance management and local systems. Liability Legal responsibility for an action or event. National Reporting and Learning System (NRLS) A confidential and anonymous computer-based system developed by the NPSA for the collection and analysis of patient safety incident information. It receives incident reports from NHS organisations, staff and contractor professions and, in time, patients and carers. Near miss See ‘Prevented patient safety incident’. NHS-funded healthcare See ‘NHS organisation’ NHS organisation Any area where NHS-funded patients are treated, i.e., NHS establishments or services, independent establishments including private healthcare or the patient’s home or workplace. Either all or part of the patient’s care in these settings is funded by the NHS. This may also be referred to as NHS-funded healthcare. NPSA The National Patient Safety Agency was set up in July 2001 following recommendations from the Chief Medical Officer in his report on patient safety, An organisation with a memory. Its role is to improve the safety of patients by promoting a culture of reporting and learning from patient safety incidents. Patient safety The process by which an organisation makes patient care safer. This should involve risk assessment, the identification and management of patient related risks, the reporting and analysis of incidents, and the capacity to learn from and follow up on incidents and implement solutions to minimise the risk of them recurring. The term ‘patient safety’ is replacing ‘clinical risk’, ‘non-clinical risk’ and the ‘health and safety of patients’. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 7 of 31 Document Title: Being Open Policy Patient safety incident Any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS-funded healthcare. The terms ‘patient safety incident’ and ‘prevented patient safety incident’ will be used to describe ‘adverse events’ / ‘clinical errors’ and ‘near misses’ respectively. Prevented patient safety incident Any unexpected or unintended incident that was prevented, resulting in no harm to one or more patients receiving NHS-funded healthcare. Risk The chance of something happening that will have an impact on individuals and/or organisations. It is measured in terms of likelihood and consequences. Risk management Identifying, assessing, analysing, understanding and acting on risk issues in order to reach an optimal balance of risk, benefit and cost. Root cause analysis (RCA) A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individual concerned and seeks to understand the underlying causes and environmental context in which an incident happened. Safety A state in which risk has been reduced to an acceptable level. Standard Sets out agreed specifications and/or procedures designed to ensure that a material, product, method or service is fit for the purpose and consistently performs in the way it is intended. Significant event audit (SEA) An audit process where data is collected on specific types of incidents that are considered important to learn about and improve patient safety. Suffering Experiencing anything subjectively unpleasant. This may include pain, malaise, nausea and/or vomiting, loss, depression, agitation, alarm, fear, grief, or humiliation. Systems failure A fault, breakdown or dysfunction within operational methods, processes or infrastructure. Systems improvement The changes made to improve operational methods, processes and infrastructure to ensure better quality and safety. Treatment Broadly, the management and care of a patient to prevent or cure disease or reduce suffering and disability. 1.4 Purpose Being Open is a process rather than a one-off event. With this in mind, ten principles have been drawn up to underpin the policy. Some of the principles listed are discussed in more detail in subsequent sections of this policy document. This policy provides guidance for Health Care staff on the principles of open communication with patients and carers following patient safety incidents. This policy should be followed in conjunction with the Incident Management Policy in the event of patient safety incidents which have resulted in harm. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 8 of 31 Document Title: Being Open Policy 1.5 Scope The scope of this document is Trust wide and applies to the wider organisation encompassing Wiltshire Community Health Services In the case of near miss or no harm incidents, patients are not usually contacted or involved in investigations and these types of incidents are outside the scope of the Being Open policy. 1.6 Regulatory Position 1.7 Data Protection Act 1998 Human Rights Act 1998 Freedom of Information Act 2000 Care Quality Commission Outcome 4 NHSLA Risk Management Standards Special Cases None. 1.8 Comments Any comments on this document should, in the first instance, be addressed to the Clinical Risk Manager. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 9 of 31 Document Title: Being Open Policy 2 Roles and Responsibilities Trust Board The Trust board retains corporate responsibility for the Being Open policy. Ensuring that a Being open policy is in place and fully implemented throughout the organisation Chief Executive The Chief Executive has overall responsibility for Being Open within the Trust, ensuring that the principles and policy are embedded in the organisation The Chief Executive will fulfil this responsibility by leading by example in fostering a culture of fair blame and non-punitive reporting within the Trust. The Chief Executive will be made aware of individual serious incidents via the Medical Director and the Director of Workforce and Education. Non-Executive Director Medical Director Associate Director of Quality and Patient Safety Investigation Executive lead Investigation Lead The Chair of the Patient Safety and Quality Committee is responsible for ensuring that the Being Open principles and policy are embedded in the organisation. The Medical Director will be made aware of all serious incidents. They have executive responsibility for ensuring that these incidents are managed, external reports made as necessary and investigations undertaken appropriately and that the Being Open policy is implemented and forms part of the incident management process. The post maintains an overview of all incidents and ensures a robust monitoring and reporting system is in place. The post also oversees and ensures serious incident reports inform the clinical and corporate governance committees. An Executive lead will be identified for each Serious Incident investigation. They are responsible for identifying the Lead Investigator in conjunction with the Clinical Risk Team, overseeing the investigation and for ensuring that Being Open is an integral part of the incident management process. An Investigation Lead will be identified by the Investigation Lead Executive for all Serious Incidents. The Lead Investigator should be a member of staff who has undertaken incident investigation training or equivalent experience. The Lead Investigator will usually be identified within the directorate in which the incident occurred but outside of the immediate speciality or department. The Investigation Lead is responsible for ensuring the robust investigation of an incident and for ensuring that Being Open forms an integral part of the incident management process. Patient Safety and Quality Committee (PSQC) The Patient Safety and Quality Committee function is to improve quality and reduce clinical risk by co-ordinating the implementation and monitoring of cross directorate clinical governance and clinical risk management. They will review all serious incidents on a monthly basis and make recommendations for directorate and organisational improvements in clinical practice. Being Open Advisors Provide mentoring and support to colleagues. A Being Open advisor should only be asked to lead Being Open discussions when appropriate. Their Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 10 of 31 Document Title: Being Open Policy primary role is to provide support to their colleagues in implementing Being Open. Senior managers (e.g. modern matrons, AMDs, general managers) On notification of an adverse incident the senior line manager, must ensure that all appropriate steps have been taken and that the situation has been made safe. They must insure that the Incident Management Policy and Being Open policies are followed within their directorate and that staff are adequately supported to implement the polices effectively. Responsible for ensuring that staff within the directorate are provided opportunity to access short term and long term support following a patient safety incident, complaint or claim. Line managers On notification of an adverse incident the line manager, must ensure that the situation has been made safe and that the incident is managed in line with the Incident Management Policy. They are responsible for ensuring that the Being Open process described within this policy is followed for all low and moderate harm incidents. As a line manager they have responsibility for ensuring that all staff reportable to them have adequate immediate and ongoing support following a patient safety incident, complaint or claim. All staff The Being Open policy applies to all staff that have key roles in patient’s care. Clinical Risk Team The Clinical Risk Team are responsible for advising on and ensuring compliance with the Incident Management and Being Open policies throughout the organisation. The Clinical Risk Manager will champion the Being Open Policy and act as a Being Open advisor. Patient Advice and Liaison Service (PALS) Responsible for highlighting patient safety incidents to the clinical risk, litigation and health and safety teams which are uncovered through the complaints procedures. Ensuring that the principles and processes described in the Being Open policy are considered as part of the management of complaints. See Also Trust Complaints Policy. The Head of Patient Experience will champion the Being Open Policy and act as a Being Open advisor within the Trust. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 11 of 31 Document Title: Being Open Policy 3 Introduction Being Open is a set of principles that healthcare staff should use when communicating with patients, their families and carers following a patient safety incident in which a patient has been harmed. Being Open involves: • acknowledging, apologising and explaining when things go wrong; • conducting a thorough investigation into the incident and reassuring patients, their families and carers that lessons learned will help prevent the incident recurring; • providing support for those involved to cope with the physical and psychological consequences of what happened. In 2005, the National Patient Safety Agency (NPSA) issued a Safer Practice Notice advising the NHS to develop a local Being Open policy and to raise awareness of this policy with all healthcare staff. In November 2009 the NPSA published the revised Being Open framework in order to strengthen the Being Open throughout the NHS. Communicating effectively with patients, their families and carers is a vital part of the process of dealing with patient safety incidents in healthcare. Research has shown that patients are more likely to forgive medical errors when they are discussed in a timely and thoughtful manner and that Being Open can decrease the trauma felt by patients following a patient safety incident. Openness also has benefits for healthcare professionals as it can: help to reduce stress through the use of a formalised, honest, communication method; alleviate the fear of ‘being found out’; and improve job satisfaction by: ensuring that communication with patients, their families and carers has been handled in the most appropriate way; helping the healthcare professional to develop a good professional reputation for handling difficult situation properly; improving the healthcare professional’s understanding of incidents from the perspective of the patient, their family and carers. The benefits of Being Open are widely recognised and supported by policy makers, professional bodies, and litigation and indemnity bodies, including the Department of Health, General Medical Council (GMC), National Health Service Litigation Authority (NHSLA), Medical Defence Union (MDU) and the Medical Protection Society (MPS). The NHS Constitution for England embeds the principles of Being Open as a pledge to patients in relation to complaints and redress. It states: ”The NHS also commits when mistakes happen to acknowledge them, apologise, explain what went wrong and put things right quickly and effectively.” The Constitution recommends that staff should view the services they provide from the standpoint of a patient, and involve patients, their families and carers in the services they provide, working with them, their communities and other organisations. The work of the Welsh project ‘Putting Things Right’ and its interim guidance (September 2009) echo these messages. The GMC in their handbook Good Medical Practice also advises that: Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 12 of 31 Document Title: Being Open Policy “If a patient under your care has suffered serious harm, through misadventure, or for any other reason, you should act immediately to put matters right, if that is possible. You should explain fully to the patient what has happened and the likely long and short-term effects. When appropriate you should offer an apology” Fear of legal action may be preventing some healthcare professionals from being open with patients, but the MDU, MPS, NHSLA and Welsh Risk Pool have all issued recent guidance to reassure healthcare professionals that they are not admitting liability if they apologise when something has gone wrong Appendix A summarises Quick Reference Guide to Being Open When Patients Are Harmed. 3.1 The principles of Being Open The following set of principles has been developed to help healthcare organisations create and embed a culture of Being Open. 3.1.1 Acknowledgement All patient safety incidents should be acknowledged and reported as soon as they are identified. 3.1.2 Truthfulness, timeliness and clarity of communication. Information about a patient safety incident must be given to patients and/or their carers in a truthful and open manner by an appropriate person. Patients want a step-by-step explanation of what happened, that considers their individual needs and is delivered openly. Communication should also be timely: patients 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. Healthcare staff should explain that new information may emerge as an incident investigation is undertaken, and patients and/or their carers should be kept up-to-date with the progress of an investigation. Patients 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, and using medical jargon which they may not understand should be avoided. 3.1.3 Apology Patients and/or their carers should receive a sincere expression of regret for the harm that has resulted from a patient safety incident. This should be in the form of an appropriately worded and agreed manner of apology, as early as possible. Both verbal and written apologies should be given. Based on the circumstances, clinical teams and/or, in the case where a patient has suffered severe harm or death, incident investigation leads should decide on the most appropriate member of staff to issue these apologies to patients and/or their carers. The decision should consider seniority, relationship to the patient, and experience and expertise in the type of patient safety incident that has occurred. Verbal apologies are essential because they allow face-to-face contact between the patient and/or their carers and the healthcare 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 multi-disciplinary Being Open discussion with the patient and/or their carers; fear and apprehension; or lack of staff availability. Delays are likely to increase the patient’s and/or their carer’s sense of anxiety, anger or frustration. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 13 of 31 Document Title: Being Open Policy A written apology, which clearly states the Trust is sorry for the suffering and distress resulting from the incident, must also be given. 3.1.4 Recognising patient and carer expectations. Patients and/or their carers can reasonably expect to be fully informed of the issues surrounding a patient safety incident, and its consequences, in a face-to-face meeting with representatives from the Trust. They should be treated sympathetically, with respect and consideration. Confidentiality must be maintained at all times. Patients 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 patient requiring additional support, such as an independent patient advocate or a translator. Where appropriate, information on the Patient Advisory and Liaison Service (PALS) in England, the Community Health Councils (CHC) in Wales and other relevant support groups like Cruse Bereavement Care (www.crusebereavementcare.org.uk/) and Action against Medical Accidents (AvMA) should be given to the patient as soon as it is possible. 3.1.5 Professional support. The Trust supports an environment in which all staff, whether directly employed or independent contractors, are encouraged to report patient safety incidents. Staff should expect to feel supported throughout the incident investigation process because 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. To ensure a robust and consistent approach to incident investigation, the Trust advocates the use of the NPSA’s incident decision tree (IDT). The IDT has been developed as an aid to improve the consistency of decision making about whether human error or systems failures contributed to an incident. It is designed for use by anyone who has the authority to exclude a member of staff from work following a patient safety incident (including medical and nursing directors, chief executives and human resources staff). More details can be found on the NPSA website: http://www.nrls.npsa.nhs.uk/resources/type/toolkits/?q=0%c2%acroot%c2%ac&entryid45=59900 Where there is reason for the healthcare organisation 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. The Trust also encourages staff 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. 3.1.6 Risk management and systems improvement. Root cause analysis (RCA), or similar techniques should be used to uncover the underlying causes of a patient safety incident. Investigations should focus on improving systems of care, which will then be reviewed for their effectiveness. 3.1.7 Multidisciplinary responsibility. Where multi-disciplinary teams are involved, communication with patients 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. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 14 of 31 Document Title: Being Open Policy 3.1.8 Clinical governance. Being Open requires the support of patient safety and quality improvement processes through clinical governance frameworks, in which patient safety incidents are investigated and analysed, to find out what can be done to prevent their recurrence. 3.1.9 Confidentiality. The procedures for Being Open must give full consideration of, and respect for, the patient’s and/or their carer’s and staff privacy and confidentiality. Communications with parties outside of the clinical team should be on a strictly need-to-know basis and, where practicable, records should be anonymous. Details of a patient safety incident should at all times be considered confidential. In addition, it is good practice to inform the patient and/or their carers about who will be involved in the investigation before it takes place. 3.1.10 Continuity of care Patients are entitled to expect they will continue to receive all usual treatment and continue to be treated with respect and compassion. If a patient expresses a preference for their healthcare needs to be taken over by another team, the appropriate arrangements should be made for them to receive treatment elsewhere. A key part of Being Open is considering the patient’s needs or the needs of their carers or family in circumstances where the patient has died. 4 Being Open Advisors The NPSA requires that Trusts identify individuals to mentor and support fellow clinicians. The Directorate Associate Medical Directors, Director of Transition, Clinical Risk Manager, Medical Director, Director of Nursing and Midwifery and the Head of Patient Experience can be contacted for advice and support with the Being Open process. In the event of severe harm or death of a patient resulting from a patient safety incident, advice should always be sought prior to any Being Open communication. A Being Open Advisor should only be asked to lead Being Open discussions when appropriate. Their primary role is to provide support to their colleagues in implementing Being Open. Being Open Advisors should: • Support fellow healthcare professionals with Being Open by: –– mentoring colleagues during their first Being Open discussion; –– advising on the Being Open process; –– being accessible to colleagues prior to initial and subsequent Being Open discussions; –– facilitating the initial team meeting to discuss the incident when appropriate; –– signposting the support services within the organisation for colleagues involved in Being Open discussions; –– facilitating debriefing meetings following Being Open discussions; –– mentoring colleagues to become Being Open advisors • Support fellow healthcare professionals in dealing with patient safety incidents by: –– signposting the support services within the organisation for colleagues involved in patient safety incident discussions; –– advising on the reporting system for patient safety incidents. • Practice and promote the principles of Being Open. For further information about this role please see the supporting resources on the NRLS website at: www.nrls.npsa.nhs.uk/beingopen Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 15 of 31 Document Title: Being Open Policy 5 Being Open Process Being Open is a process rather than a one off event. There are a number of stages in the process. The duration depends on the incident, the needs of the patient, their family and carers, and how the investigation into the incident progresses. Figure 1 5.1 Stage 1: Incident detection or recognition The Being Open process begins with the recognition that a patient has suffered harm or has died as a result of a patient safety incident. Incidents may be identified by: A member of staff at the time of the incident; A member of staff retrospectively when an unexpected outcome is detected; Outside the incident reporting process usually by way of a complaint, legal claim, Coroner’s Officer or media interest; A patient, their family or carers who express concern or dissatisfaction with the patient’s healthcare either at the time of the incident or retrospectively; Incident detection systems such as incident reporting or medical records review; Other sources such as detection by other patients, visitors or non-clinical staff(for example, researchers observing healthcare staff) As soon as a patient safety incident is identified, the top priority is prompt and appropriate clinical care. The incident should be reported in line with the Incident Management Policy. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 16 of 31 Document Title: Being Open Policy 5.1.1 Patient Safety incidents which have occurred elsewhere A patient safety incident may have occurred in an organisation other that the one in which it is identified. The individual who identifies the possibility of an earlier patient safety incident should complete an electronic incident form (or paper IR1/RM1).The Clinical Risk and Health and Safety teams will then contact their equivalent at the organisation where the incident occurred. The Being Open process and the investigation and analysis of a patient safety incident should normally occur in the healthcare organisation where the incident took place. 5.1.2 Initial assessment to determine level of response All incidents should be assessed initially by the healthcare team to determine the level of response required, the level of response to a patient safety incident depends on the nature of the incident. Figure 2 Grading of patient safety incidents to determine level of Being Open response Incident No harm (including prevented near miss patient safety incidents) Low harm - short term injury resolved in about 1 month, lacerations. Moderate harm - semipermanent injury that will take at least a year to resolve, includes emotional, psychological or physical harm.. Severe harm or death – longterm or permanent harm, such as brain damage or disability. Level of response Patients are not usually contacted or involved in investigations, these types of incidents are outside the scope of the Being Open policy. Unless there are specific indications or the patient requests it, the communication, investigation and analysis, and the implementation of changes will occur at local department level with the participation of those directly involved in the incident. Reporting to the Clinical Risk Manager will occur through the incident reporting system and be analysed to detect themes. Review will occur through local investigation as described within the Incident Management Policy. Communication should normally take the form of an open discussion between the staff providing the patient’s care and the patient, their family and carers Apply the principles of Being Open Summary of Being Open communication should be documented on the corresponding incident form. A higher level of response is required in these circumstances. Being Open discussions will normally take the form of an open discussion between the staff providing the patient’s care and the patient, their family. The Trust Being Open advisors (Directorate Associate Medical Director, Clinical Risk Manager, Medical Director, Director of Nursing and Midwifery or the Head of Patient Experience) can be contacted prior to any Being Open communication taking place. Apply the principles of Being Open Summary of Being Open communication should be documented on the corresponding incident form. Patient safety incidents resulting in severe harm or death are reported and managed as Serious Incidents in line with the Incident Management policy. The Trust Being Open advisors (Directorate Associate Medical Director, Clinical Risk Manager, Medical Director, Director of Nursing and Midwifery or the Head of Patient Experience) must be contacted prior to any Being Open communication taking place. The Executive Lead and Lead Investigator will be responsible for overseeing the Being Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 17 of 31 Document Title: Being Open Policy Open process. Apply the principles of Being Open A summary of Being Open communications will be included within the incident investigation report. 5.2 Stage 2: Preliminary team discussion The multidisciplinary team, including the most senior health professional involved in the patient safety incident, should meet as soon as possible after the event to: 5.2.1 establish the basic clinical and other facts; assess the incident to determine the level of immediate response; identify who will be responsible for discussion with the patient, their family and carers. In the case of severe injury or death the Executive lead and Lead investigator for the Serious Incident will be responsible for overseeing the Being Open process and will agree who will meet with the patient, their family and carers; consider the appropriateness of engaging patient support at this early stage. This includes the use of a facilitator, a patient advocate or a healthcare professional who will be responsible for identifying the patient’s needs and communicating them back to the healthcare team; identify immediate support needs for the healthcare staff involved; ensure there is a consistent approach by all team members around discussions with the patient, their family and carers. Timing The initial Being Open discussion with the patient, their family and carers should occur as soon as possible after recognition of the patient safety incident. Factors to consider when timing this discussion include: clinical condition of the patient; patient preference (in terms of when and where the meeting takes place and which healthcare professional leads the discussion); privacy and comfort of the patient; availability of the patient’s family and/or carers; availability of key staff involved in the incident and in the Being open process; availability of support staff, for example a translator or independent advocate, if required; arranging the meeting in a sensitive location. 5.2.2 Choosing the individual to communicate with the patients, their families and carers In the case of low and moderate harm incidents this should be the most senior person responsible for the patient’s care and/or someone with experience and expertise in the type of incident that has occurred. This could either be the patient’s consultant, nurse consultant, or any other healthcare professional who has a designated caseload of patients. In the case of severe harm or death incidents the Executive Lead and Lead investigator will be responsible for ensuring that the most appropriate person communicates with the patient. They should have received training in communication of patient safety incidents. Consideration also needs to be given to the characteristics of the person nominated to lead the Being Open process. They should: ideally be known to, and trusted by, the patient, their family and carers; have a good grasp of the facts relevant to the incident; Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 18 of 31 Document Title: Being Open Policy 5.2.3 be senior enough or have sufficient experience and expertise in relation to the type of patient safety incident to be credible to patients, their families and carers, and colleagues; have excellent interpersonal skills, including being able to communicate with patients, their families and carers in a way they can understand, and avoiding excessive use of medical jargon; be willing and able to offer a meaningful apology, reassurance and feedback to patients, their families and carers; be able to maintain a medium to long-term relationship with the patient, their family and carers, where possible, and to provide continued support and information; be culturally aware and informed about the specific needs of the patient, their family and carers. Assistance with the initial Being Open discussion The healthcare professional communicating information about a patient safety incident should be able to nominate a colleague to assist them with the meeting. Ideally this would be someone with experience or training in communication and Being Open procedures. 5.2.4 Responsibility of junior healthcare professionals Junior staff or those in training should not lead the Being Open process except when all of the following criteria have been considered: the incident resulted in low harm; they have expressed a wish to be involved in the discussion with the patient, their family and carers; the senior healthcare professional responsible for the care is present for support; the patient, their family and carers agree. Where a junior healthcare professional who has been involved in a patient safety incident asks to be involved in the Being Open discussion, it is important that they are accompanied and supported by a senior team member. It is unacceptable for junior staff to communicate patient safety information alone, or to be delegated the responsibility to lead a Being Open discussion unless they volunteer and their involvement takes place in appropriate circumstances (i.e. they have received appropriate training and mentorship for this role). 5.2.5 Involving the healthcare staff who made mistakes Some patient safety incidents that resulted in moderate harm, severe harm or death can result from errors made by healthcare staff while caring for the patient. In these circumstances, the member(s) of staff involved may or may not wish to participate in the Being Open discussion with the patient, their family and carers. Every case where an error has occurred needs to be considered individually, balancing the needs of the patient, their family and carers with those of the healthcare professional concerned. In cases where the healthcare professional who has made an error wishes to attend the discussion to apologise personally, they should feel supported by their colleagues throughout the meeting. In cases where the patient, their family and carers express a preference for the healthcare professional not to be present, it is advised that a personal written apology is handed to the patient, their family and carers during the initial Being Open discussion. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 19 of 31 Document Title: Being Open Policy 5.3 Stage 3: Initial Being Open discussions The initial Being Open discussion is the first part of an ongoing communication process. Many of the points raised here should be expanded on in subsequent meetings with the patient, their family and carers. The patient, their family and carers should be advised of the identity and role of all people attending the Being Open discussion before it takes place. This allows them the opportunity to state their own preferences about which healthcare staff they want to be present. If for any reason it becomes clear during the initial discussion that the patient would prefer to speak to a different healthcare professional, the patient’s wishes should be respected. A substitute with whom the patient is satisfied should be provided. It should be recognised that patients, their families and carers may be anxious, angry and frustrated even when the Being Open discussion is conducted appropriately. The content of the initial Being Open discussion with the patient, their family and carers should cover the following: An expression of genuine sympathy, regret and a meaningful apology for the harm that has occurred. The facts that are known as agreed by the multidisciplinary team. Where there is disagreement, communication about these events should be deferred until after the investigation has been completed. The patient, their family and carers are informed that an incident investigation is being carried out and more information will become available as it progresses. The patient’s, their family’s and carers’ understanding of what happened is taken into consideration, as well as any questions they may have. Consideration and formal noting of the patient’s, their family’s and carers’ views and concerns, and demonstration that these are being heard and taken seriously. Appropriate language and terminology are used when speaking to patients, their families and carers. For example, using the terms ‘patient safety incident’ or ‘adverse event’ may be meaningless or even insulting to some patients, their families and their carers. If a patient’s first language is not English, it is also important to consider their language needs – if they would like the Being Open discussion conducted in French or Urdu for example, this should be arranged. An explanation about what will happen next in terms of the short through to long-term treatment plan and incident analysis findings. Information on likely short and long-term effects of the incident (if known). The long term effects may have to be presented at a subsequent meeting when more is known. An offer of practical and emotional support for the patient, their family and 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 patient and the incident should not normally be disclosed to third parties without consent. Information on services offered by all the possible support agencies (including their contact details) that can give emotional support, help the patient identify the issues of concern, support them at meetings with staff and provide information about appropriate community services. Contact details of a staff member who will maintain an ongoing relationship with the patient, using the most appropriate method of communication from the patient’s, their family’s and carers’ perspective. Their role is to provide both practical and emotional support in a timely manner. It is essential that the following does not occur during the Being Open discussion: Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 20 of 31 Document Title: Being Open Policy 5.4 speculation; attribution of blame; denial of responsibility; provision of conflicting information from different individuals. Stage 4: Follow-up discussions Follow-up discussions with the patient, their family and carers are an important step in the Being Open process. Depending on the incident and the timeline for the investigation there may be more than one follow-up discussion. The following guidelines will assist in making the communication effective: The discussion occurs at the earliest practical opportunity. Consideration is given to the timing of the meeting, based on both the patient’s health and personal circumstances. Consideration is given to the location of the meeting, for example at the patient’s home. Feedback is given on progress to date and information provided on the investigation process. There should be no speculation or attribution of blame. Similarly, the healthcare professional communicating the incident must not criticise or comment on matters outside their own experience. The patient, their family and carers should be offered an opportunity to discuss the situation with another relevant professional where appropriate. A written record of the discussion is kept and shared with the patient, their family and carers. All queries are responded to appropriately. If completing the process at this point, the patient, their family and carers should be asked if they are satisfied with the investigation and a note of this made in the patient’s records. The patient is provided with contact details so that if further issues arise later there is a conduit back to the relevant healthcare professionals or an agreed substitute. 5.5 5.5.1 Stage 5: Process completion Communication with the patient, their family and carers After completion of the incident investigation, feedback should take the form most acceptable to the patient. Whatever method is used, the communication should include: the chronology of clinical and other relevant facts; details of the patient’s, their family’s and carers’ concerns and complaints; a repeated apology for the harm suffered and any shortcomings in the delivery of care that led to the patient safety incident; a summary of the factors that contributed to the incident; information on what has been and will be done to avoid recurrence of the incident and how these improvements will be monitored. It is expected that in most cases there will be a complete discussion of the findings of the investigation and analysis. In some cases information may be withheld or restricted, for example, in the rare instances where communicating information will adversely affect the health of the patient; where investigations are pending coronial processes; or where specific legal requirements preclude disclosure for specific purposes. In these cases the patient must be informed of the reasons for the restrictions. 5.5.2 Continuity of care When a patient has been harmed during the course of treatment and requires further therapeutic management or rehabilitation, they should be informed, in an accessible way, of the ongoing clinical Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 21 of 31 Document Title: Being Open Policy management plan. This may be encompassed in discharge planning policies addressed to designated individuals, such as the referring GP, when the patient safety incident has not occurred in primary care. Patients, their families and carers need to be reassured that they will continue to be treated according to their clinical needs, even in circumstances where there is a dispute between them and the healthcare team. They should also be informed that they have the right to continue their treatment elsewhere if they prefer. Communication with the GP and other community care service providers for patient safety incidents not occurring in primary care Wherever possible, it is advisable to send a brief communication to the patient’s GP, before discharge, describing what happened. When the is discharged, the discharge letter should also be forwarded to the GP or appropriate community care service. It should contain summary details of: the nature of the patient safety incident and the continuing care and treatment; the current condition of the patient; key investigations that have been carried out to establish the patient’s clinical condition; recent results; prognosis.s It may be valuable to include the GP in one of the follow-up discussions either at discharge or at a later stage. 5.6 Documentation Throughout the Being Open process it is important to record discussions with the patient, their family and carers as well as the incident investigation. In the case of Low and moderate harm incidents a summary of Being Open communication should be documented on the corresponding incident form. The electronic incident reporting form includes a mandatory Being Open section. In the case of Serious harm incidents a summary of Being Open communication should be documented on the corresponding incident form and in addition documentation of communications will be included within the Root Cause Analysis investigation report. Patient safety incident documentation should include: incident report (electronic incident report form or paper IR1/RM1) records of the investigation and analysis process (electronic managers form IR1/RM1) . or paper Written records of the Being Open discussions may consist of: the time, place and date, as well as the name and relationships of all attendees; the plan for providing further information to the patient, their family and carers; offers of assistance and the patient’s, their family’s and carers’ response; questions raised by the family and carers, and the answers given; plans for follow-up meetings; progress notes relating to the clinical situation and an accurate summary of all the points explained to the patient, their family and carers; copies of letters sent to the patient, their family and carers, and the GP for patient safety incidents not occurring within primary care; copies of any statements taken in relation to the patient safety incident; a copy of the incident report. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 22 of 31 Document Title: Being Open Policy A summary of the Being Open discussions should be shared with the patient, their family and carers. 6 Patient issues to consider 6.1 Communication For open and effective communication following patient safety incidents, staff responsible for undertaking Being Open discussions should: Ensure early identification of, and consent for, the patient’s practical and emotional needs, including: the names of people who can provide assistance and support to the patient, and to whom the patient has agreed that information about their healthcare can be given. This person (or people) may be different to both the patient’s next of kin and from people who the patient had previously agreed should receive information about their care prior to the patient safety incident; any special restrictions on openness that the patient would like the healthcare team to respect; identifying whether the patient does not wish to know every aspect of what went wrong; respect their wishes and reassure them that this information will be made available if they change their mind later on. Provide repeated opportunities for the patient, their family and carers to obtain information about the patient safety incident. Provide information to patients in verbal and/ or written format. Provide assurance that an ongoing care plan will be developed in consultation with the patient and will be followed through. Provide assurance that the patient will continue to be treated according to their clinical needs and that the prospect of, or an actual dispute between, the patient, their family and carers and the healthcare team will not affect their access to treatment. Facilitate inclusion of the patient’s family and carers in discussions about a patient safety incident where the patient agrees. Provide the patient’s family and carers with access to information to assist in making decisions if the patient is unable to participate in decision making or if the patient has died as a result of an incident. This should be done with regard to confidentiality and in accordance with the patient’s instructions. Determine whether you will need to repeat this information to the patient at different times to allow them to comprehend the situation fully. Ensure that the patient’s family and carers are provided with known information, care and support if a patient has died as a result of a patient safety incident. The carers should also be referred to the coroner for more detailed information. Ensure that discussions with the patient, their family and carers are documented and that information is shared with them. Ensure that the patient, their family and carers are provided with information on the complaints procedure if they wish to have it. Ensure that the patient, their family and carers are provided with information on the incident reporting process. Ensure that the patient’s account of the events leading up to the patient safety incident is fed into the incident investigation, whenever applicable. Ensure that the patient, their family and carers are provided with information on how improvement plans derived from investigations will be implemented and their effects monitored. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 23 of 31 Document Title: Being Open Policy 6.2 Advocacy and support Patients, their families and carers may need considerable practical and emotional help and support after experiencing a patient safety incident. The most appropriate type of support may vary among different patients, their families and carers. It is therefore important to discuss with the patient, their families and carers their individual needs. Support may be provided by patients’ families, social workers, religious representatives and healthcare organisations such as PALS, Independent Complaints Advocacy Service (ICAS) and CHCs in Wales. Where the patient needs more detailed long-term emotional support, advice should be provided on how to gain access to appropriate counselling and support services, for example, from Cruse Bereavement Care and AvMA. 6.3 Particular patient circumstances The approach to Being Open may need to be modified according to the patient’s personal circumstances. The following gives guidance on how to manage different categories of patient circumstances. 6.3.1 When a patient dies When a patient safety incident has resulted in a patient’s death, it is even more crucial that communication is sensitive, empathic and open. It is important to consider the emotional state of bereaved relatives or carers and to involve them in deciding when it is appropriate to discuss what has happened. The patient’s family and carers will probably need information on the processes that will be followed to identify the cause(s) of death. They will also need emotional support. Establishing open channels of communication may also allow the family and/or carers to indicate if they need bereavement counselling or assistance at any stage. Usually, the Being Open discussion and any investigation occur before the coroner’s inquest. But in certain circumstances the healthcare organisation may consider it appropriate to wait for the coroner’s inquest before holding the Being Open discussion with the patient’s family and carers. The coroner’s report on post-mortem findings is a key source of information that will help to complete the picture of events leading up to the patient’s death. In any event an apology should be issued as soon as possible after the patient’s death, together with an explanation that the coroner’s process has been initiated and a realistic timeframe of when the family and carers will be provided with more information. The investigation team should request the Legal Services Manager to contact the Coroner’s Officer allocated as liaison to the family, to discuss the most appropriate method of managing the Being Open discussion. 6.3.2 Children The legal age of maturity for giving consent to treatment is 16 years old. It is the age at which a young person acquires the full rights to make decisions about their own treatment and their right to confidentiality becomes vested in them rather than their parents or guardians. However, it is still considered good practice to encourage competent children to involve their families in decision making. The courts have stated that younger children who understand fully what is involved in the proposed procedure can also give consent. This is sometimes known as Gillick competence or the Fraser guidelines25. Where a child is judged to have the cognitive ability and the emotional maturity to understand the information provided, he/she should be involved directly in the Being Open process after a patient safety incident. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 24 of 31 Document Title: Being Open Policy The opportunity for parents to be involved should still be provided unless the child expresses a wish for them not to be present. Where children are deemed not to have sufficient maturity or ability to understand, consideration needs to be given to whether information is provided to the parents alone or in the presence of the child. In these instances the parents’ views on the issue should be sought. 6.3.3 Patients with mental health issues Being Open for patients with mental health issues should follow normal procedures, unless the patient also has cognitive impairment (see 4.3.4 Patients with cognitive impairments’). The only circumstances in which it is appropriate to withhold patient safety incident information from a patient with mental health issues, is when advised to do so by a consultant psychiatrist who feels it would cause adverse psychological harm to the patient. However, such circumstances are rare and a second opinion (by another consultant psychiatrist) would be needed to justify withholding information from the patient. Apart from in exceptional circumstances, it is never appropriate to discuss patient safety incident information with a carer or relative without the express permission of the patient. 6.3.4 Patients with cognitive impairment Some individuals have conditions that limit their ability to understand what is happening to them. They may have authorised a person to act on their behalf by an enduring Power of Attorney. In these cases, steps must be taken to ensure that this extends to decision making and to the medical care and treatment of the patient. The Being Open discussion would be conducted with the holder of the power of attorney. Where there is no such person, the clinicians may act in the patient’s best interest in deciding who the appropriate person is to discuss incident information with, regarding the welfare of the patient as a whole and not simply their medical interests. However, the patient with a cognitive impairment should, where possible, be involved directly in communications about what has happened. An advocate with appropriate skills should be available to the patient to assist in the communication process. See 4.3.5 Patients with learning disabilities for details of appropriate advocates. 6.3.5 Patients with learning disabilities Where a patient has difficulties in expressing their opinion verbally, an assessment should be made about whether they are also cognitively impaired (see 4.3.4 Patients with cognitive impairment’). If the patient is not cognitively impaired they should be supported in the Being Open process by alternative communication methods (e.g. given the opportunity to write questions down). An advocate, agreed on in consultation with the patient, should be appointed. Appropriate advocates may include carers, family or friends of the patient. The advocate should assist the patient during the Being Open process, focusing on ensuring that the patient’s views are considered and discussed. 6.3.6 Patients with a different language or cultural considerations The need for translation and advocacy services, and consideration of special cultural needs (such as for patients from cultures that make it difficult for a woman to talk to a male about intimate issues), must be taken into account when planning to discuss patient safety incident information. It would be worthwhile to obtain advice from an advocate or translator before the meeting on the most sensitive way to discuss the information. Avoid using ‘unofficial translators’ and/or the patient’s family or friends as they may distort information by editing what is communicated. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 25 of 31 Document Title: Being Open Policy 6.3.7 Patients with different communication needs A number of patients will have particular communication difficulties, such as a hearing impairment. Plans for the meeting should fully consider these needs. Knowing how to enable or enhance communications with a patient is essential to facilitating an effective Being Open process. This involves focusing on the needs of the patient, their family and carers, and being personally thoughtful and respectful. 6.3.8 Patients who do not agree with the information provided Sometimes, despite the best efforts of healthcare staff or others, the relationship between the patient, their family and carers and the healthcare professional breaks down. They may not accept the information provided or may not wish to participate in the Being Open process. In this case, the following strategies may assist: deal with the issue as soon as it emerges; where the patient agrees, ensure their family and carers are involved in discussions from the beginning; ensure the patient has access to support services; where the senior health professional is not aware of the relationship difficulties, provide mechanisms for communicating information, such as the patient expressing their concerns to other members of the clinical team; offer the patient, their family and carers another contact person with whom they may feel more comfortable. This could be another member of the team or the individual with overall responsibility for clinical risk management; use a mutually acceptable mediator to help identify the issues between the healthcare organisation and the patient, and to look for a mutually agreeable solution; ensure the patient, their family and carers are fully aware of the formal complaints procedures; write a comprehensive list of the points that the patient, their family and carers disagree with and reassure them you will follow up these issues. 7 Supporting staff When a patient safety incident occurs, healthcare professionals involved in the patient’s clinical care may also require emotional support and advice. For further information please refer to the Trust Policy Supporting Staff Involved in Incidents Complaints or Claims. 7.1 Training support The Being Open advisors are required to complete the NPSA e-learning training resource. Clinical staff have access to the Patient Safety module, available on training tracker. Incident investigation and Being Open training resources: An e-learning tool: ‘Being Open’. http://www.nrls.npsa.nhs.uk/resources/collections/beingopen/ An e-learning tool: ‘A guide to root cause analysis from the NPSA’, http://www.nrls.npsa.nhs.uk/resources/?entryid45=59901; The Incident Decision Tree is available via the Clinical Risk intranet pages; Patient Safety training tracker module Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 26 of 31 Document Title: Being Open Policy Clinical Risk Intranet pages Further advice and support can be accessed by contacting the Clinical Risk Manager ext 5562 (bleep 1322). Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 27 of 31 7.2 Monitoring Measurable Objectives Policy Regulator NHSLA, 1.Being Open process – CQC compliance with the process for encouraging open communication between healthcare organisations, healthcare teams, staff, patients and/or their carers 2.Compliance with the process for acknowledging, apologising and explaining when things go wrong. Monitoring/ Audit Method Monitoring responsibility (individual/grou p/ committee) Frequency of monitoring Compliance with Being open process is Clinical Risk Continuous monitored by clinical risk for all reported Manager process serious incidents, Being Open arrangements for each SI documented on serious incident monitoring tool. Reporting arrangements (committee/group the monitoring results is presented) monitoring Directorate Governance reports All serious incidents are reported and PSQC Monthly PSQC presented to PSQC, compliance with Being Open process forms part of the report. Clinical Risk Concurrent monitoring via PSQC Compliance with Being Open policy manager safeguard system audited via Safeguard system Being Open is a mandatory section on the electronic reporting form. 3.Compliance with the requirements for truthfulness, timeliness and clarity of information c. Compliance with the NHSLA, requirement for CQC documenting all communication. Incidents resulting in low, moderate, severe harm or death must should The Trust Investigation report template Clinical Risk All serious includes a summary of involvement and Manager reports support provided to patients and/or relatives, this section must be completed prior to sign off. Compliance with Being Open policy Clinical Risk incident PSQC PSQC, CSG Document Title: Being Open Policy have a documented record of Being Open communication . audited via Safeguard system – Being Manager Open is a mandatory section on the electronic reporting form. Concurrent monitoring via safeguard system Qualitatative audit of Being Open Clinical Risk communication record to be Department 6 monthly undertaken, including WCHS paper incident forms. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 1.0 Printed on 06/02/2016 at 5:05 PM Page 29 of 31 CSG Appendix A – Quick reference guide to Being Open Quick reference guide to being open The principles of Being Open are fully supported by a wide range of Royal Colleges and professional organisations. Apologising and explaining when patients have been harmed can be very difficult. You may have already considered some or all of the recommendations below, but this guide will help ensure that you follow best practice. Do also refer to your organisation’s local policy before proceeding. Patients and/or carers should receive an apology as soon as possible after a patient safety incident has occurred and staff should feel able to apologise on the spot. Saying sorry is not an admission of liability and it is the right thing to do. Patients have a right to expect openness in their healthcare. Stage 1: preliminary meeting with the patient and/or their carers Who should attend? • A lead staff member who is normally the most senior person responsible for the patient’s care and/or someone with experience and expertise in the type of incident that has occurred. • Ensure that those members of staff who do attend the meetings can continue to do so; continuity is very important in building relationships. • The person taking the lead should be supported by at least one other member of staff, such as risk manager, nursing or medical director, or member of the healthcare team treating the patient. • Ask the patient and/or their carers who they would like to be present. • Consider each team member’s communication skills; they need to be able to communicate clearly, sympathetically and effectively. • Hold a pre-meeting amongst healthcare professionals so that everyone knows the facts and understands the aims of the meeting. When should it be held? • As soon after the incident as possible. • Consider the patient’s and/or their carer’s home and social circumstances. • Check that they are happy with the timing. • Offer them a choice of times and confirm the chosen date in writing. • Do not cancel the meeting unless absolutely necessary. Where should it be held? • Use a quiet room where you will not be distracted by work or interrupted. • Do not host the meeting near to the place where the incident occurred if this may be difficult for the patient and/or their carers. Stage 2: discussion How should you approach the patient and/or their carers? • Speak to the patient and/or their carers as you would want someone in the same situation to communicate with a member of your own family. • Do not use jargon or acronyms: use clear, straightforward language. Document Title: Being Open Policy • Consider the needs of patients with special circumstances, for example, linguistic or cultural needs, and those with learning disabilities. What should be discussed? • Introduce and explain the role of everyone present to the patient and/or their carer and ask them if they are happy with those present. • Acknowledge what happened and apologise on behalf of the team and the organisation. Expressing regret is not an admission of liability. • Stick to the facts that are known at the time and assure them that if more information becomes available, it will be shared with them. • Do not speculate or attribute blame. • Suggest sources of support and counselling. • Check they have understood what you have told them and offer to answer any questions. • Provide a named contact who they can speak to again. Stage 3: follow-up • Clarify in writing the information given, reiterate key points, record action points and assign responsibilities and deadlines. • The patient’s notes should contain a complete, accurate record of the discussion(s) including the date and time of each entry, what the patient and/or their carers have been told, and a summary of agreed action points. • Maintain a dialogue by addressing any new concerns, share new information once available and provide information on counselling, as appropriate. For more information on the NPSA’s Being open work visit: www.npsa.nhs.uk © National Patient Safety Agency 2005. Copyright and other intellectual property rights in this material belong to the NPSA and all rights are reserved. The NPSA authorises healthcare organisations to reproduce this material for educational and non-commercial use. Note: This document is electronically controlled. The master copy of the latest approved version is maintained by the owner department. If this document is downloaded from a website or printed, it becomes uncontrolled. Version 0.2 Printed on 06/02/2016 at 5:05 PM Page 31 of 31