Provide Group is committed to improving patient safety and improving communication between healthcare professionals and patients, their families, and when appropriate carers, when a patient is harmed as a result of a clinical adverse event. Thecommunication is known as Being Open and we have a statutory obligation to fulfil our duty of candour.
Being open encompasses communication between healthcare providers, healthcare teams and patients. Since April 2015 all providers of NHS health care are subject to a statutory duty of candour and there will be fines implemented of up to £10,000 for organisations who are not upholding their responsibility in this area. A statutory duty of candour will ensure honesty and transparency are the norm in every organisation overseen by the CQC. Health and social care workers will be held more accountable and there will be the possibility of the introduction of legal sanctions at corporate level for providers who knowingly generate misleading information or withhold information from patients or relatives.
The policy primarily describes the process required in relation to clinical adverse events that have caused moderate harm, severe harm or death and not to incidents that have caused low harm or no harm. However it is important to note that however minor the incident we have an obligation to inform the service user of any error that has occurred in the delivery of our services to them.
The effects of harming a patient can be widespread. It is therefore essential that communication between healthcare teams and service users and/or their carers’ and family, following a clinical adverse event, is carried out appropriately. Incidents can have devastating emotional and physical consequences for patients and their families or carers.
For the staff involved too, incidents can be distressing. Being open about what happened and discussing clinical adverse events promptly, fully and compassionately can help people cope better with the after-effects.
2. Introduction
The Being Open process begins with the recognition that a patient has suffered moderate harm, severe harm, or has died as a result of a patient safety incident.
Patient Safety Incident is defined by NHS England as any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving healthcare. Reporting them supports the NHS to learn from mistakes, and to take action to keep patients safe.
Openness and honesty towards patients are supported and actively encouraged by many professional bodies including the Medical Protection Society (MPS), The Medical Defence Union (MDU), Nursing and Midwifery Council (NMC) and the General Medical Council (GMC), whose Good Medical Practice Guide contains the following statement on a clinician’s ‘duty of candour’.
All members of staff are encouraged to report patient safety incidents that are prevented (i.e. near misses) no harm and low harm incidents, as well as patient safety incidents that caused moderate harm, severe harm or death. If a patient has suffered any harm, 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. If the patient is under 16 and lacks the maturity to consent to treatment you should explain the situation honestly to those with parental responsibility for the child, or for a patient that lacks mental capacityto consent to treatment you should explain to the person who consented to treatment.
All members of staff are also encouraged to act in a similar manner with respect to complaints
Saying sorry is not an admission of liability; it is the right thing to do. Patients have a right to expect openness in their healthcare.
Following the publication of the ‘Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry’ (2013), all organisations have a statutory duty to be open with patients when things go wrong with their healthcare, and give them information about any investigations that have taken place or any lessons learned - a Duty of Candour.
Elements of the Being Open policy are also related to other government initiatives and recommendations from major inquiry reports, including:
• Recommendations in the 5th Shipman Inquiry Report about appropriate documentation of patient deaths
• The Mid Staffordshire NHS Foundation Trust Public Inquiry (2013). The Francis Report
• Gosport Report (2018)
N.B. Throughout this policy, the terminology of ‘incident’ should be interpreted as either incident or complaint, depending on the circumstances, and the relevant policy followed in conjunction with the Being Open Policy.
Professional Duty of Candour
In joint guidance between the Nursing and Midwifery Council and the General Medical Council in June 2015 the professional duty of candour is clearly set out as:
Every healthcare professional must be open and honest with patients when something that goes wrong with their treatment or care causes, or has the potential to cause, harm or distress. This means that healthcare professionals must:
• Tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong
• Apologise to the patient (or, where appropriate, the patient’s advocate, carer or family)
• Offer an appropriate remedy or support to put matters right (if possible)
• Explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family), the short and long term effects of what has happened
• Healthcare professionals must also be open and honest with their colleagues, employers and relevant organisations, and take part in reviews and investigations when requested. They must also be open and honest with their regulators, raising
concerns where appropriate. They must support and encourage each other to be open and honest, and not stop someone from raising concerns
For full document see Appendix B
The Organisational Duty of Candour
The CQC has put in place a requirement for healthcare providers to be open with patients and apologise when things go wrong. This duty applies to all registered providers of both NHS and independent healthcare bodies, as well as providers of social care from 1 April 2015. The organisational duty of candour does not apply to individuals, but organisations providing healthcare will be expected to implement the new duty throughout their organisation by making sure that staff understand the duty and are appropriately trained.
Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 intends to make sure that providers are open and transparent in relation to care and treatment with people who use their services. It also sets out some specific requirements that providers must follow when things go wrong with care or treatment, including informing people about the incident, providing reasonable support, giving truthful information and apologising when things go wrong. The CQC can prosecute for a breach of parts 20(2) a, and 20(3) of this regulation.
See Appendix C for full CQC regulation
3. Scope and Implementation of this Policy
Provide Group QSPOL01 Incident Reporting & Management Policy encourages all staff to report all patient safety incidents, including those where there was no harm or it was a prevented patient safety incident (see Glossary section 9).
This policy is concerned with the implementation of the organisational duty of candour which relates to those incidents graded Death (Red), Severe (Orange) or Moderate (Yellow) in line with national parameters defined in Care Quality Commission Outcome 20 (appendix C). When applied correctly, these grades equate to events significant enough to be deemed ‘Serious Incidents’. For the purpose of clarity, all events deemed serious incidents in line with QSPOL01 Incident Reporting and Management Policy must exercise the organisational duty of candour.
Incidents graded as Low (green) or No Harm (Low) must be dealt with less formally in accordance with the professional duty of candour.
4. Key Elements of Being Open
Effective communication with service users begins at the start of their referral into our services and should continue throughout their time with Provide Group This should be no different when a safety incident occurs. Openness about what happened and discussing safety incidents promptly, fully and compassionately can help patients cope better with the after-effects. Safety incidents also incur extra costs through litigation and further treatment; openness and honesty can help prevent such events becoming formal complaints and litigation claims. Openness when things go wrong is fundamental to the partnership between service users and those who provide their care.
For Provide Group, Being Open involves:
• acknowledging and apologising for the situation - we can apologise without admitting liability and this is essential prior to the investigation
• conducting a thorough investigation into the incident and reassuring service users and/or their carers and family that lessons learned will help prevent the incident reoccurring
• providing support to cope with the physical and psychological consequences of what happened
For healthcare staff, Being Open has several benefits, including:
• satisfaction that communication with service users and/or their carers and family following a safety incident has been handled in the most appropriate way
• improving the understanding of incidents from the perspective of the service users and their family
• the knowledge that lessons learned from incidents will help prevent them happening again
• having a good professional reputation for handling a difficult situation well and earning respect among peers and colleagues
Acknowledgement
All safety incidents should be acknowledged and reported as soon as they are identified. In cases where the service user, their family, and carers inform healthcare staff when something untoward has happened, it must be taken seriously from the outset. Any concerns should be treated with compassion and understanding by all healthcare professionals.
Truthfulness, Timeliness and Clarity of Communication
Information about a safety incident must be given to patients, their families and carers in a truthful and open manner by an appropriately nominated person. People should be provided with a step-by-step explanation of what happened that considers their individual needs and is delivered openly.
Communication should also be timely: Service users, their families and carers should be provided with information about what happened as soon as practicable.
The Statutory Duty of Candour states that the initial written apology must be sent with 10 working days of the incident occurring, by organisations operating under the standard NHS contract (CQC Regulation 20: 20(2)).
It is also essential that any information given is based solely on the facts known at the time. Healthcare professionals should explain that new information may emerge as an incident investigation is undertaken, and that they will be kept up-to-date with the progress of an investigation.
People 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 the use of medical jargon, which they may not understand, should be avoided
Apology
Service users, their families and carers should receive a meaningful apology – one that is a sincere expression of sorrow or regret for the harm that has resulted from a safety incident. This should be in the form of an appropriately worded and agreed manner of apology as early as possible. This is not an admission of liability but an apology for the current circumstances.
Based on local circumstances, Provide Group Assistant Directors should decide on the most appropriate member of staff to give both verbal and written apologies to patients, their families and carers. The decision should consider seniority, relationship to the patient, and experience and expertise in the type of safety incident that has occurred. All written communication must be agreed by the area Assistant Director and copied to the Director of Nursing and Allied Health Professionals & Quality Assurance prior to being sent.
Verbal apologies are essential because they allow face-to-face contact between the service user, their family and carers and the healthcare team. This should be given as soon as staff become aware an incident has occurred. A written apology, which clearly states that Provide is sorry for the suffering and distress resulting from the incident, must also be given.
It is important not to delay giving a meaningful apology for any reason, including: setting up a more formal multidisciplinary discussion with the service user, their family and carers; fear and apprehension; or lack of staff availability. Delays are likely to increase the anxiety, anger or frustration. Patient and public focus groups reported that patients were more likely to seek medical legal advice if verbal and written apologies were not delivered promptly.
Recognising Patient and Carer Expectations
Service users, their families and carers can reasonably expect to be fully informed of the issues surrounding a safety incident and its consequences in a face-to-face meeting with representatives from Provide Group. They should be treated sympathetically, with respect and consideration. They should also be provided with support in a manner appropriate to their needs. This involves consideration of special circumstances that can include someone requiring additional support, such as an independent advocate or translator
Professional Support
Provide Group is committed to an environment in which all staff, whether directly employed or independent contractors, are encouraged to report safety incidents. Staff should 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.
Where there is a reason for Provide Group to believe a member of staff has committed a punitive or criminal act, the organisation 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.
Provide Group will also encourage 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.
Risk Management and Systems Improvement
Root Cause Analysis (RCA), is the method adopted by Provide Group in relation to understanding and learning from a safety incident. These investigations should focus on improving systems of service delivery, which will then be reviewed for their effectiveness.
Multidisciplinary Responsibility
This policy applies to all staff, the majority of service users are cared for by a multidisciplinary team and this should be reflected in the way that service users, their families and carers are communicated with when things go wrong.
Governance
Being Open utilises patient safety and quality improvement processes through the clinical governance framework in which patient safety incidents are investigated and analysed. Identification of root causes helps to identify what can be done to prevent their recurrence and reshape systems and processes accordingly. The outcome of investigations that offer learning opportunities must be disseminated to healthcare professionals so that they can learn from patient safety incidents
It also involves a system of accountability through the Chief Executive to the Board to ensure these changes are implemented and their effectiveness reviewed. Continuous learning programmes and audits must be developed that allow Provide to learn from the service user’s experience of Being Open and the fulfilment of the Duty of Candour, that monitor the implementation and effects of change in practice following a safety incident.
Confidentiality
Service users, families and staff should be given full respect following a safety incident and confidentiality must be maintained throughout the investigation process and post investigation.
The consent of the individual concerned should be sought prior to disclosing information beyond the staff delivering the service. Communications with parties outside of the immediate team should also be on a strictly need-to-know basis and records should be anonymous. In addition, it is good practice to inform the service user, their family and carers about who will be involved in the investigation before it takes place and give them the opportunity to raise any concerns.
Continuity of Care
Service users are entitled to expect that they will continue to receive all usual treatment and continue to be treated with dignity, respect and compassion. If a service user 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.
5. The Being Open Process
Incident Detection or Recognition
The Being Open process begins with the recognition that a person has suffered moderate harm, major harm, or has died as a result of a safety incident.
A safety incident 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
• a service user and/or their carers who express concern or dissatisfaction with the service delivered 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 service users, visitors or non-clinical staff
As soon as a safety incident is identified, the top priorities are prompt and appropriate clinical care and prevention of further harm. Where additional treatment is required this should occur whenever reasonably practicable after a discussion with the service user and with appropriate consent. The Incident Management & Reporting Policy should be implemented.
This would include:
• acknowledgement and apology not necessarily admitting liability but an apology for the current circumstances
• completion of Datix
• Instigation of the Root Cause Analysis investigation
Patient Safety Incidents Occurring Elsewhere
A patient incident may have occurred in an organisation other than Provide Group The individual who first identifies the possibility of an earlier incident should report the incident via Datix which will notify the Clinical Quality team who will then contact the organisation where the incident occurred
The Being Open process, the investigation and analysis of a patient safety incident should normally occur in the healthcare organisation where the incident took place
Criminal or Intentional Unsafe Act
Incidents are almost always unintentional. However, if at any stage following an incident it is determined that harm may have been the result of a criminal or intentional unsafe act, the Quality and Safety team should be notified immediately.
Initiating the Being Open Process
The multi-disciplinary team, including the most senior health professional involved in the incident, (this will be either the Assistant Director of the Business Unit, the Director of Nursing and Allied Health Professionals and the Head of Quality Assurance) should meet as soon as possible after the event to:
• Establish the basic facts
• Assess the incident and determine the level of immediate response, including appropriate level of investigation as detailed in QSPOL01 Incident Reporting and Management Policy.
• Identify who will be responsible for discussion with the patient and/or their carers
• Consider the appropriateness of engaging service user 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 needs of the service user and communicating them back to the healthcare team
• Identify immediate support needs for their healthcare staff involved
• Ensure there is a consistent approach by all team members
Low Harm (Minimal Harm)
Unless there are specific indications or the patient requests it, the communication, investigation and analysis, and the implementation of changes will occur at local service delivery level with the participation of those directly involved in the incident. Reporting to the Quality and Safety team will occur through standard incident reporting mechanisms and be analysed centrally to detect high frequency events. Review will occur through aggregated trend data and local investigation. Where the trend data indicates a pattern of related events, further investigation and analysis may be needed.
Communication should take the form of an open discussion between the staff providing the care and the service user, their family and carers.
Moderate Harm (short term harm), Severe Harm (permanent or long term) or Death (caused by the incident) (definitions as per CQC regulation 20 ref Appendix C)
A higher level of response is required in these circumstances. Director of Nursing and Allied Health Professionals should be notified immediately and be available to provide support and advice during all aspects of the investigation process.
Timing
The initial Being Open discussion with the patient and/or their carers should occur as soon as possible after recognition of the incident. Factors to consider when timing this discussion include:
• Clinical and psychological condition of the service user. Some people may require more than one meeting to ensure that all the information has been communicated to and understood by them
• Availability of key staff involved in the incident and in the Being Open process
• Availability of the service users family and/or carers
• Availability of support staff, for example a translator or independent advocate, if required
• Privacy and comfort of the service user
• Arranging the meeting in a sensitive location
The Statutory Duty of Candour states that the initial written apology must be sent with 10 working days of the incident occurring, by organisations operating under the standard NHS contract (CQC Regulation 20: 20(2)).
Choosing the Individual to Communicate with Service Users and/or their Carers and Family
The healthcare professional who informs the service user about a safety incident should:
• Be known to, and trusted by, the service user
• Have a good grasp of the facts relevant to the incident
• Be senior enough or have sufficient experience and expertise in relation to the type of incident to be considered credible
• Have excellent interpersonal skills. This includes the ability to communicate with the service user, families and their carers in a way they can understand. It is important to avoid excessive use of medical jargon
• Be willing and able to offer an apology, reassurance and feedback
• Be culturally aware and informed about the specific needs of the service user
Use of a Substitute Healthcare Professional for the Being Open Discussion
In exceptional circumstances, if the healthcare professional who usually leads the Being Open discussion cannot attend, they may delegate to an appropriately trained substitute. The qualifications, training and scope of responsibility of this person should be clearly described. This is essential for effective communication
Consultation with the Patient regarding the Healthcare Professional leading the Being Open Discussion
If for any reason it becomes clear during the initial discussion that the service user would prefer to speak to a different healthcare professional, the service user’s wishes should be respected. A substitute should be provided.
Responsibilities of Junior Healthcare Professionals
Junior staff or those in training should not lead the Being Open process except when all the following criteria have been considered:
• the incident resulted in low harm
• the senior healthcare professional responsible for the care is present for support
• the service user agrees
Patient Safety Incidents related to the Environment of Care
In such cases a senior manager of the relevant service will be responsible for communicating with the service user and their family. A senior member of the multidisciplinary team should be present to assist at the initial Being Open discussion
Involving Healthcare Staff who made Mistakes
Every case where an error has occurred needs to be considered individually, balancing the needs of the service user and families 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 service user express a preference for the healthcare professional not to be present, it is advised that a personal written apology is handed to the service user during the first Being Open discussion
Content of the Initial Being Open Discussion with the Service User and their Family
With the service user’s agreement, carers and those close to the patient can be included in the discussions and decision making. If the service user is unable to participate or has died, then the people closely involved with the patient may be provided with limited information in order to make decisions.
• The service user 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 staff should be present
• There should be an expression of genuine sympathy, regret and a meaningful apology for the harm that has occurred
• The known facts are agreed by the multidisciplinary team. Where there is disagreement, communication about these events should be deferred until after the investigation has been completed. The service user and family should be informed that an incident investigation is being carried out and more information will become available as it progresses.
• It should be made clear to the service user that new facts may emerge as the incident investigation proceeds
• The service user and family’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 and family’s views and concerns, and demonstration that these are being heard and taken seriously
• Appropriate language and terminology should be used when speaking to service user and their family. For example, using the terms ‘patient safety incident’ or ‘adverse event’ may be meaningless. If a person’s first language is not English, or they have other communication difficulties, their language needs should be addressed as well as providing information in both verbal and written formats
• An explanation should be given about what will happen next in terms of the long term treatment plan and incident analysis 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 when the situation becomes clearer. Some patients may not wish to know every detail of an incident. They should be reassured that if they change their minds, this information will be made available to them
• An offer of practical and emotional support should be made to the service user. This may involve giving information on third parties such as charities and voluntary organisations, as well as offering more direct assistance. The service user should be given the contact details of one member of staff who will acts as a contact point for them. Their role will be to provide both practical and emotional support in a timely manner
• Service users should be given information on the complaints procedure, and offered assistance if they wish to make a complaint
• It should be recognised that service users and families may be anxious, angry and frustrated, even when the Being Open discussion is conducted appropriately
It is essential that the following does not occur:
• Speculation
• Attribution of blame
• Denial of responsibility
• Provision of conflicting information from different individuals
Certain patient types or circumstances will require a different approach. See Appendix A for a breakdown of these
Notification
In all cases, the Head of Quality and Safety should be informed either by telephone, electronically or by completion of the incident form.
Management
The clinician who discovers the incident should report it through their line manager. When a serious incident occurs (see Incident Management Policy for definition) or where a criminal act is suspected, the Chief Executive, or if out of hours, the on call manager must be notified immediately
The Coroner
All cases of untimely, unexpected or unexplained death or suspected unnatural deaths need to be reported to the coroner. A coroner may request the case is not discussed with
other parties until the facts have been considered. However this should not preclude a verbal and written apology or expression of regret where appropriate. In this situation it should be made clear to the family that a full discussion of the circumstances and any residual concerns will be arranged at a date to suit both parties after the coroner’s assessment is finished. It should also be recognised that coroner investigations are stressful for patients, families, carers and staff. Bereavement counselling and advice on professional support groups should be offered at the outset of a coroner’s investigation
Relevant Statutory/Other Bodies
The Incident Reporting and Management Policy details the external agencies that should be informed of a patient safety incident and when this should occur. The Head of Quality and Safety is responsible for notifying these relevant agencies such as the Clinical Commissioning Groups, National Health Service Litigation Authority and the Care Quality Commission. The Head of Safety and Resilience is responsible for notifying the Health & Safety Executive (RIDDOR).
6. General
The terminology of ‘incident’ should be interpreted as either ‘incident, complaint or claim’, depending on the circumstances, and the relevant policy followed in conjunction with this policy.
The communication of safety incidents must be recorded. Required documentation includes:
• A copy of relevant medical information, which should be filed in the patient’s medical records
• Incident reports recorded on Datix
• Records of the investigation and analysis process
The incident report and record of the investigation and analysis process will be recorded on the incident database and retained in the Quality and Safety (incidents), Contracts (claims) or Customer Service (complaints) files as appropriate
The initial incident will be reported using the procedures detailed within the Incident Reporting and Management Policy and will be recorded on the Provide Incident Database.
7. Written Records of the Being Open Discussion
There should be documentation of:
• The time, place, date, as well as the name and relationships of all attendees
• The plan for providing further information
• Offers of assistance and the service user’s response
• Questions raised by the family or their representatives and the answers given
• Plans for follow-up as discussed
• Copies of letters sent to service user, carers and the GP for safety incidents not occurring within Provide
• Copies of any statements taken in relation to incident
• A copy of the incident report
A summary of the Being Open discussion should be shared with the patient.
Completing the Process
Communication with the Service User
After completion of the incident investigation, feedback should take the form most acceptable to the service user. Whatever method is used, the communication should include:
• The chronology of clinical and other relevant facts
• Details of the service users concerns
• 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
Continuity of Care
When a service user 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 management plan. This may be encompassed in discharge planning policies addressed to designated individuals, such as the referring GP, when the safety incident has not occurred within the organisation.
Service users should 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 have lost confidence in the healthcare team involved in the incident.
Monitoring
Any recommendations for system improvements and changes implemented will be detailed in an improvement plan. This will be linked to the incident on the incident database. The progress, final completion of and effectiveness of the improvement plan will be monitored and reported to the Quality & Safety Committee by the Head of Quality and Safety
Communication of Changes to Staff
Effective communication with staff is a vital step in ensuring that recommended changes are fully implemented and monitored. It will also facilitate the move towards increased
awareness of safety issues and the value of Being Open. Team meetings, newsletters and the Provide website are all available to help communicate with staff.
8. Monitoring and Feedback
The results of Being Open discussions with the service user will be fed back by the manager leading the process to the Head of Quality and Safety for inclusion on the incident database to facilitate the analysis and audit of compliance with the Being Open process.
9. Counter Fraud and Bribery
Fraud is where any person who dishonestly makes a false representation to make a gain for himself or another or dishonestly fails to disclose to another person, information which he is under a legal duty to disclose, or commits fraud by abuse of position, including any offence as defined in the Fraud Act 2006.
Bribery
Bribery is the giving or receiving a financial or other advantage in connection with the ‘improper performance’ of trust or a function that is expected to be performed impartially or in good faith. Where the Provide Group is engaged in commercial activity it could be considered guilty of a corporate bribery offence if an employee, agent, subsidiary or any other person acting on its behalf bribes another person intending to obtain or retain business or an advantage in the conduct of business for the Provide Group and it cannot demonstrate that it has adequate procedures in place to prevent such. The adequate procedures that the Provide Group is required to have in place to prevent bribery being committed on their behalf are performed by six principles – proportionate procedures, toplevel commitment, risk assessment, communication (including training), monitoring and review. The Provide Group does not tolerate any bribery on its behalf, even if this might result in a loss of business for it. Criminal liability must be prevented at all times.
Counter Fraud
If any member of staff has good reason to suspect a colleague, patient or other person of fraud, bribery and / or corruption, involving the Provide Group, they should report their genuine concerns to the Local Counter Fraud Specialists (LCFS) or Executive Finance Director immediately. The LCFS will then decide on the next course of action and advise the member of staff accordingly. All calls are dealt with in the strictest of confidence and callers may remain anonymous.
Suspicions of fraud, bribery or corruption should be reported to the Local Counter Fraud Specialists on telephone 0845 300 3333, Provide’s Chief Executive Officer or NHS Counter Fraud Authority (NHSCFA) via an online reporting form: https://cfa.nhs.uk/reportfraud: or NHSCFA Freephone: 0800 028 4060. Further details including email addresses for those responsible can be found on Provide’s Intranet.
Individuals suspected of committing an offence of fraud, bribery or corruption may be subject to criminal and/or disciplinary investigation, which could result in criminal and/or disciplinary action being taken, including prosecution and/or dismissal. For more information, please refer to the Local Anti-Fraud, Bribery and Corruption Policy or to Provide’s Counter Fraud intranet pages.
10. Glossary
Safety Incident
Any unintended or unexpected incident that could have or did lead to harm for one or more service users receiving NHS-funded healthcare. The terms ‘safety incident’ and ‘prevented safety incident’ will be used to describe ‘adverse events’ / ‘clinical errors’ and ‘near misses’ respectively.
Near Miss See ‘Prevented safety incident’.
Prevented safety incident (old term’ near miss’s)
Service user safety
Any unexpected or unintended incident that was prevented, resulting in no harm to one or more service users receiving NHSfunded healthcare.
The process by which an organisation makes care safer. This should involve risk assessment, the identification and management of service user 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.
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.
11.References
• “Being Open”, National Patient Safety Agency, 2009
• The Francis Report March 2013
• Care Quality Commission (2015) Duty of candour: Information for all providers: NHS Bodies, adult social care, primary medical and dental care, and independent healthcare /20150327_duty_of_candour_guidance_
• final.pdf (accessed 15 June 2015)CQC duty of candour April 2014
• General Medical Council (2013) Good medical practice available at: www.gmcuk.org/gmp(accessed 15 June 2015), paragraphs 24 and 55
• Nursing and Midwifery Council (2015) The Code: Professional standards of practice and behaviour for nurses and midwives available at:www.nmc.org.uk/code (accessed 15 June2015), section 14
• The Supreme Court (2015) Judgment: Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) available at: ttps://www.supremecourt.uk/cases/docs/ uksc-2013-0136-judgment.pdf
• National Health Service Report a patient safety incident available at: www.nrls.npsa.nhs.uk/ report-a-patient-safety-incident/ (accessed 16 June 2015)
• The Supreme Court (2015) Judgment: Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) available at: ttps://www.supremecourt.uk/cases/docs/ uksc-2013-0136-judgment.pdf (accessed 15June 2015), paragraphs 86-91
• NHS England, available at https://www.england.nhs.uk/patient-safety/reportpatient-safety-incident/
Appendix A: Special Circumstances
When a Service User Dies
When a safety incident has resulted in a death it is 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 family and/or 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 should occur before the Coroner’s Inquest. However, 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 family and/or 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 death. In any event an apology should be issued as soon as possible after the death, together with an explanation that the coroner’s process has been initiated and a realistic time frame of when the family and/or carers will be provided with more information.
Children
The legal age of maturity for giving consent to treatment is 16. 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 Guidelines. 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 safety incident. 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. More information can be found in Provides Consent Policy or on the Department of Health’s website: www.dh.gov.uk
Patients with mental health issues
Being Open for people with mental health issues should follow normal procedures, unless the person also has cognitive impairment (see below). The only circumstances in which it is appropriate to withhold incident information from a mentally ill patient is when advised to do so by a Consultant Psychiatrist who believes it would cause adverse psychological harm. However, such circumstances are rare and a second opinion (by another Consultant Psychiatrist) would be needed to justify withholding information. Apart from in exceptional circumstances, it is never appropriate to discuss safety incident information with a carer or relative without the express permission of the service user. To do so is an infringement of the patient’s Human Rights.
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 this extends to decision making and to the medical care and treatment of the service user. The Being Open discussion would be held with the holder of the Power of Attorney. Where there is no such person the clinicians may act in the service user’s best interest in deciding who the appropriate person is to discuss incident information with, regarding the welfare of the person 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.
Patients with learning disabilities
Where a person has difficulties in expressing their opinion verbally, an assessment should be made about whether they are also cognitively impaired (see above). If the service user is not cognitively impaired they should be supported in the Being Open process by alternative communication methods (i.e. given the opportunity to write questions down). An advocate, agreed on in consultation with the person, should be appointed. Appropriate advocates may include carers, family or friends. The advocate should assist during the Being Open process, focusing on ensuring that the service user’s views are considered and discussed.
Patients who do not agree with the information provided
Sometimes, despite the best efforts of healthcare staff or others, the relationship between the service user 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 service user agrees, ensure their carers are involved in discussions from the beginning
• Ensure there is access to support services
• Offer the service user 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 service user and to look for a mutually agreeable solution
• Ensure the service user and/or their carers are fully aware of the formal complaints procedures
Service users with a different language or cultural considerations
The need for translation and advocacy services, and consideration of special cultural needs (such as for service users from cultures that make it difficult for a woman to talk to a male person about intimate issues), must be taken into account when planning to discuss 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.
Patients with different communication needs
A number of service users will have particular communication difficulties, such as a hearing impairment. Plans for the meeting should fully consider their needs.
Knowing how to enable or enhance communications with a person is essential to facilitating an effective Being Open process. There should be a focus on the needs of individuals and their families, with thoughtful and respectful communication.
Appendix B: Professional Duty of Candour
NMC: Openness & Honesty When Things Go Wrong
Appendix C: Organisational Duty of Candour, CQC Regulation 20
CQC Regulation 20: Duty of Candour
Appendix D: Flow chart
Incident / Event Reported in to Datix and to Manager
Not Designated
Serious Incident
Professional duty of candour Managed locally and documented within the patient record and on Datix
Designated Serious Incident
Initiate the being open process. Multidisciplinary team (MDT) meeting including the most senior health professional involved Assistant Director of the Business unit, Assistant Director of Clinical Practice & Quality Assurance and / or Head of Quality Assurance
Initial conversation by MDT appointed individual
Initial duty of candour letter from Assistant Director of Business Unit within 10 days of incident being identified
Investigation in line with level identified by MDT with regard to QSPOL01- All Incident Reporting & Management Policy
Share report findings and second duty of candour letter unless person affected requests no further contact.
EQUALITY IMPACT ASSESSMENT
TEMPLATE: Stage 1: ‘Screening’
Name of project/policy/strategy (hereafter referred to as “initiative”):
QSPOL03 Duty of Candour Being Open Policy
Provide a brief summary (bullet points) of the aims of the initiative and main activities:
Provide is committed to improving patient safety and improving communication between healthcare professionals and patients and/or carers when a patient is harmed as a result of a clinical adverse event. The communication is known as Being Open. The effects of harming a patient can be widespread. It is therefore essential that communication between healthcare teams and patients and/or their carers following a clinical adverse event is carried out appropriately. Incidents can have devastating, emotional and physical consequences for patients and their families or carers.
This stage establishes whether a proposed initiative will have an impact from an equality perspective on any particular group of people or community – i.e. on the grounds of race (incl. religion/faith), gender (incl. sexual orientation), age, disability, or whether it is “equality neutral” (i.e. have no effect either positive or negative). In the case of gender, consider whether men and women are affected differently.
Q1. Who will benefit from this initiative? Is there likely to be a positive impact on specific groups/communities (whether or not they are the intended beneficiaries), and if so, how? Or is it clear at this stage that it will be equality “neutral”? i.e. will have no particular effect on any group.
Neutral
Q2. Is there likely to be an adverse impact on one or more minority/under-represented or community groups as a result of this initiative? If so, who may be affected and why? Or is it clear at this stage that it will be equality “neutral”?
Neutral
Q3. Is the impact of the initiative – whether positive or negative - significant enough to warrant a more detailed assessment (Stage 2 – see guidance)? If not, will there be monitoring and review to assess the impact over a period time? Briefly (bullet points) give reasons for your answer and any steps you are taking to address particular issues, including any consultation with staff or external groups/agencies.
Guidelines: Things to consider
• Equality impact assessments at Provide take account of relevant equality legislation and include age, (i.e. young and old,); race and ethnicity, gender, disability, religion and faith, and sexual orientation.
• The initiative may have a positive, negative or neutral impact, i.e. have no particular effect on the group/community.
• Where a negative (i.e. adverse) impact is identified, it may be appropriate to make a more detailed EIA (see Stage 2), or, as important, take early action to redress this – e.g. by abandoning or modifying the initiative. NB: If the initiative contravenes equality legislation, it must be abandoned or modified.
• Where an initiative has a positive impact on groups/community relations, the EIA should make this explicit, to enable the outcomes to be monitored over its lifespan.
• Where there is a positive impact on particular groups does this mean there could be an adverse impact on others, and if so can this be justified? - e.g. are there other existing or planned initiatives which redress this?
• It may not be possible to provide detailed answers to some of these questions at the start of the initiative. The EIA may identify a lack of relevant data, and that data-gathering is a specific action required to inform the initiative as it develops, and also to form part of a continuing evaluation and review process.
• It is envisaged that it will be relatively rare for full impact assessments to be carried out at Provide. Usually, where there are particular problems identified in the screening stage, it is envisaged that the approach will be amended at this stage, and/or setting up a monitoring/evaluation system to review a policy’s impact over time.
EQUALITY IMPACT ASSESSMENT TEMPLATE: Stage 2:
(To be used where the ‘screening phase has identified a substantial problem/concern)
This stage examines the initiative in more detail in order to obtain further information where required about its potential adverse or positive impact from an equality perspective. It will help inform whether any action needs to be taken and may form part of a continuing assessment framework as the initiative develops.
Q1. What data/information is there on the target beneficiary groups/communities? Are any of these groups under- or over-represented? Do they have access to the same resources? What are your sources of data and are there any gaps?
n/a
Q2. Is there a potential for this initiative to have a positive impact, such as tackling discrimination, promoting equality of opportunity and good community relations? If yes, how? Which are the main groups it will have an impact on?
n/a
Q3. Will the initiative have an adverse impact on any particular group or community/community relations? If yes, in what way? Will the impact be different for different groups – e.g. men and women?
n/a
Q4. Has there been consultation/is consultation planned with stakeholders/ beneficiaries/ staff who will be affected by the initiative? Summarise (bullet points) any important issues arising from the consultation.
n/a
Q5. Given your answers to the previous questions, how will your plans be revised to reduce/eliminate negative impact or enhance positive impact? Are there specific factors which need to be taken into account?
n/a
Q6. How will the initiative continue to be monitored and evaluated, including its impact on particular groups/ improving community relations? Where appropriate, identify any additional data that will be required.
n/a
Guidelines: Things to consider
• An initiative may have a positive impact on some sectors of the community but leave others excluded or feeling they are excluded. Consideration should be given to how this can be tackled or minimised.
• It is important to ensure that relevant groups/communities are identified who should be consulted. This may require taking positive action to engage with those groups who are traditionally less likely to respond to consultations, and could form a specific part of the initiative.
• The consultation process should form a meaningful part of the initiative as it develops, and help inform any future action.
• If the EIA shows an adverse impact, is this because it contravenes any equality legislation? If so, the initiative must be modified or abandoned. There may be another way to meet the objective(s) of the initiative.
Further information:
Useful Websites www.equalityhumanrights.com Website for new Equality agency www.employers-forum.co.uk – Employers forum on disability www.disabilitynow.org.uk – online disability related newspaper www.efa.org.uk – Employers forum on age
