1. Excellence in specialist and community healthcare Duty of Candour Sal Maughan, Head of Risk Management

2. Duty of Candour  Formally came into force on 27 November 2014 for NHS Trusts, Foundation Trusts, and Special Health Authorities in England:  Statutory Duty: Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – read alongside CQC Guidance, March 2015  Professional Duty: GMC/NMC Guidance, Openness and honesty when things go wrong, June 2015  Contractual Duty: Commissioning contract imposes fines for non-adherence to statutory duty *Best practice for all clinical staff for many years Duty of Candour / St George’s University Hospitals NHS Foundation Trust

3. Duty Defined  In essence, to take the initiative in acting in a open and transparent way when dealing with a “relevant person”:  patient  person lawfully acting on behalf of a patient if :- is a child, can’t make a decision for themselves, has died. Duty of Candour / St George’s University Hospitals NHS Foundation Trust

4. Who owes the duty?  For legal purposes the statutory duty of candour is owed by the Trust  However, everyone has a role to play  Providers have to ensure that all staff, “regardless of seniority or permanency”, know about the organisation’s responsibilities.  The professional duty of candour is owed by all registered healthcare professionals Duty of Candour / St George’s University Hospitals NHS Foundation Trust

5. ‘What does it mean to be open and transparent?  ‘Open’ means: enabling concerns and complaints to be raised freely without fear and questions asked to be answered.  ‘Transparent’ means: allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators. Duty of Candour / St George’s University Hospitals NHS Foundation Trust

6. When is the duty triggered?  When the Trust is aware that a ‘notifiable’ safety incident has occurred - when it discovers a patient has suffered harm  It is an incident that is unintended or unexpected that occurs when a patient is being treated/cared for; and could result in or appears to have resulted in: a) the death of the service user; or b) severe harm, moderate harm, or prolonged psychological harm.  Near miss? Duty of Candour / St George’s University Hospitals NHS Foundation Trust

7. Level of harm  Death – the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition;  Severe harm – means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage.  Moderate harm – means harm that requires a moderate increase in treatment, and significant, but not permanent harm.  Moderate increase in treatment – means an unplanned return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, transfer to another treatment area (e.g. ITU)  Prolonged psychological harm - psychological harm a patient has experienced, or is likely to experience, for a continuous period of at least 28 days. Must notify if the degree of harm is not yet clear but could result in one of the above  Must notify if the degree of harm is not yet clear but could result in:- Duty of Candour / St George’s University Hospitals NHS Foundation Trust

8. Must do:  Notify the patient or “relevant person” that the incident happened as soon as reasonably practicable  10 working days, and sooner where possible  Must be given in person by one/more representatives of the Trust.  Who should give it? Consider‘ seniority, relationship to the person using the service, and experience and expertise  It is an account, true to the best of the Trust’s knowledge, of all the facts the Trust knows about the incident at that date. Duty of Candour / St George’s University Hospitals NHS Foundation Trust

9. Oral & written notification  Ensure the patient or representative can understand.  State what further enquiries/investigation will happen.  Apologise (express sorrow or regret) - this won’t amount to an admission of liability (CQC/NHSLA)  Provide reasonable support to the relevant person. Treat them with respect and empathy. Provide information about support groups, counselling and complaints procedures.  Keep a written record – medical records  Follow up in writing  Continuing duty to inform patient, in writing, of further enquiries and investigations, should they wish to receive this information – SI or RCA report  The Trust must keep a copy of all correspondence. Duty of Candour / St George’s University Hospitals NHS Foundation Trust

10. Consequences of non-compliance  It is a criminal offence: summary offence punishable by fine (currently £2,500)  Sanction imposed on Trust  Can also be imposed on directors  Professional Consequence: Disciplinary proceedings before one of the health regulators  Contractual: Fine of cost of care episode or £10k if unknown.  CQC Enforcement action – fail to meet fundamental standards to be open and transparent  Possibility of having to reimburse part or all of NHSLA’s compensation costs Duty of Candour / St George’s University Hospitals NHS Foundation Trust

11. Policy and training & demonstrating compliance  Being open/duty of candour policy – on intranet  Ensure when reporting incidents – Datix section completed and record in notes  Template letters available – DGMs and Risk team  Make sure there is a process in place for supporting the staff involved – involve OH?  Training – Head of Risk/Risk Team  Reporting  internal – DGB/PSC/QRC  External – CCG monthly  Audits – internal and external CCG/CQC (Dec 2015) Duty of Candour / St George’s University Hospitals NHS Foundation Trust

12. Duty of candour Discussion / case studies Duty of Candour / St George’s University Hospitals NHS Foundation Trust