THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST. DUTY OF CANDOUR - NEW CONTRACTUAL REQUIREMENT Guidance and frequently asked questions

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1 Agenda item A5(v) THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST DUTY OF CANDOUR - NEW CONTRACTUAL REQUIREMENT Guidance and frequently asked questions 1. What is the Duty of Candour? It is a requirement under the NHS Standard Contract 2013/14, issued by the NHS Commissioning Board, to ensure that patients/their families are told about patient safety incidents that affect them, receive appropriate apologies, are kept informed of investigations and are supported to deal with the consequences ( NHS Standard Contract, Technical Guidance). 2. Which incidents does the Duty of Candour apply to? The duty applies to patient safety incidents that occur during care provided under the NHS Standard Contract and that result in moderate harm, severe harm or death. NB: The Duty of Candour also applies to suspected incidents which have yet to be confirmed, where the suspected result is moderate harm, severe harm or death. The NPSA definitions of levels of harm are:- No harm: Impact prevented any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHSfunded care. Impact not prevented any patient safety incident that ran to completion but no harm occurred to people receiving NHS-funded care. Low: Any patient safety incident that required extra observation or minor treatment and caused minimal harm, to one or more persons receiving NHS-funded care. Moderate: Any patient safety incident that resulted in a moderate increase in treatment (e.g. increase in length of hospital stay by 4-15 days) and which caused significant but not permanent harm, to one or more persons receiving NHS-funded care. Severe: Any patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS-funded care. Death: Any patient safety incident that directly resulted in the death of one or more persons receiving NHS-funded care. 3. What is the difference to Being Open? Duty of Candour is the contractual requirement to ensure the Being Open Policy is followed when a patient safety incident occurs resulting in moderate harm, severe harm, or death. 1

2 4. When does the Duty of Candour apply? The duty applies to all relevant incidents occurring from April Therefore Commissioners will expect evidence of compliance as part of contract monitoring. st 5. What are the requirements of the Duty of Candour? The requirements are listed in Appendix 1. The area which remains to be agreed relates to which department or person will be responsible for carrying out some of the requirements. These areas are not prescribed within the NHS Standard Contract and must be locally determined. 6. How will we know if an incident has occurred that meets the requirements? To ensure staff are made aware of incidents that may meet the requirements, CGARD plan to change the incident report form so that the reporter is required to give an initial severity grading. Currently the grading is added by the investigator but this may result in a breach of the 10 day time frame. To support the change of practice the grading guidance has been updated to provide actual examples. Once the DATIX system is changed it is recommended that Matrons, Directorate Managers and Clinical Directors should be set up to receive notification if an incident is graded as Moderate or above. 7. Where should we record the letter and notes from meetings? It is recommended that all documents should be attached to the Datix incident form so the information is available for contract monitoring purposes and if additional evidence is required by the commissioners. Reference to any meetings offered or refused should also be recorded in the patient s notes. 8. Is there an agreed format for letters or reports? The template attached to the Being Open Policy should be used to invite the patient and/or relatives to an initial meeting. The invitation should come from the Directorate Manager or Clinical Director. A Word version is attached (see Appendix 2). Further letter(s) summarising meetings with the patient/relatives should be written in plain English avoiding or explaining any jargon. Further guidance on the content is included in the Being Open Policy. These letters should be submitted via CGARD and will be signed by the Chief Executive who will approve release to the patient/relative. The final investigation report should be submitted to CGARD in the usual way, as for all serious incidents, and once it has been approved by the Executive Team a copy can be sent to the patient/relatives if required. 9. What happens if we don t implement the requirements? The commissioners can withhold the cost of the episode of care or implement a fine of 10,000 if the cost is not known. In addition, they can do any/all of the following: 2

3 Send a report to the CQC Require that the Chief Executive send an apology and an explanation of the breach to the patient/relatives Publish details of the breach on the Trust web-site 10. What do we need to do next to support implementation? Ensure all staff are made aware that when they report an incident they will be required to grade the severity of the incident based on actual harm. Directorates should agree who will take responsibility for scrutinising all incidents graded moderate and above to identify those that meet the requirements of Duty of Candour and CGARD (Jackie Moon and Jane Skeates) should be informed as soon as a potential incident is identified. Mrs A O Brien Director Quality & Effectiveness 19 th June

4 Appendix 1 Requirement under Duty of Candour 1. Patient or their family/carer must be informed that a suspected or actual incident has occurred 2. Initial notification of incident must be verbal (face-to-face, where possible) unless patient or their family/carer decline notification or cannot be contacted in person. Sincere expression of regret or sorrow must be provided verbally. This must be recorded. 3. Offer of written notification. Including sincere expression of regret or sorrow must be provided in writing. Whether declined or accepted, this must be recorded. 4. Step-by-step explanation of the facts (in plain English) must be offered. This may just be an initial view, pending investigation. 5. Maintain full written documentation of any meetings. If meetings are offered but declined this must be recorded. 6. Emerging information (whether during investigation or after investigation) must be offered. 7. Share incident investigation report (including action plans) in the format they were approved in. Responsible person/ department Clinician* responsible for episode of care during, or as a result of which, the incident occurred. Directorate Manager and CGARD should be made aware/ involved. Clinician responsible for episode of care during, or as a result of which, the incident occurred. Directorate Manager should be aware/ involved. Timeframe Maximum 10 working days from incident being reported on Datix Maximum 10 working days from incident being reported on Datix As above Maximum 10 working days from incident being reported on Datix. See template letter Being Open Policy. As above. As above. All follow -up letters to patients/ relatives will be approved for release by the Chief Executive. As above CGARD to provide final copy to Directorate lead. As soon as practicable. No timeframe prescribed. See Being Open Policy As soon as practicable. Within 10 working days of report being signed off as complete and incident closed. 4

5 8. Provide plain English explanations of reports, upon request. 9. Inform patient s commissioner (and lead commissioner, if appropriate) when communicating with a patient about an incident. 10. Provide copies of any information shared with the patient to the commissioner, upon request. CGARD/Directorates to check Ad hoc. CGARD/Contracting Part of regular 6- monthly contract review, or other contractual discussions. CGARD to coordinate Ad hoc. *The clinician may be the lead doctor responsible for the patient s care but in the case of falls resulting in a fracture or trust-acquired pressure ulcers category 3 and 4 the Matron may be more appropriate. 5

6 Appendix 2 Suggested template to be used to construct communication letter in accordance with requirements of Duty of Candour (See Being Open Policy for further guidance) Dear Patient/Relative (as appropriate) You/Your. (insert relative) have/has been involved in an adverse event... describe event here I wish to express my sincere regret that this event has occurred. The Trust aims to provide a quality service to you/your (relatives as appropriate) and to investigate promptly such adverse events and share findings with those involved. To support anyone involved in an adverse incident the Trust has developed a Being Open policy. I have enclosed a leaflet with more details for your information. (If appropriate) We would like to invite (you/your relative to attend a meeting which is being organised as part of the investigation. Prior to this going ahead, I would appreciate your options on the following, in relation to this meeting. Your preference of time and date of meeting? Where would you wish to meet/proposed venue if there is any reason that this cannot be at the hospital? Who would you prefer to meet with? If you wish to do so, please feel free to bring along a friend or relative to offer you support during this meeting. Following the meeting you will be provided with further information relating to the outcome of the investigation. If you would prefer not to attend any meetings please do not hesitate to let us know. When our investigation is completed we will write to you to provide feedback regarding the outcome of the investigation. I/ Staff member XXXXX is acting as your lead contact for the duration of the being open process. I/they can be contacted on telephone number xxxxx xxxxxxx Yours sincerely 6