Reporting of serious incidents to Welsh Assembly Government

1 PUTTING THINGS RIGHT dealing with concerns Llywodraethu da calon iechyd da Good governance at the heart of good health care GUIDANCE ON THE Reporting AND HANDLING OF serious . incidents AND OTHER PATIENT RELATED CONCERNS / NO. SURPRISES. Background The existing NHS Wales serious incident (SI) Reporting requirements have been in place since April 2003 ( Reporting of Patient-Related serious Adverse incidents letter issued by John Hill-Tout). In addition to the SI process, all NHS organisations are required to report all patient safety incidents (irrespective of seriousness and degree of harm) to the National Patient Safety Agency (NPSA's) Reporting and learning System (RLS).

2 This is to inform the prioritisation and development of safety solutions, including rapid response reports and alerts, in addition to contributing to data which is published on a national and organisational basis. The Reporting of SIs to the Welsh Assembly Government and NPSA does not exclude the requirement to report to other bodies, Healthcare Inspectorate Wales, Health & Safety Executive (RIDDOR), Information Commissioner's Office, Police, Coroner, as appropriate and as required by each individual body. Definitions The definition of a SI in this context extends beyond those which impact directly on patients.

3 The NPSA has suggested the following definition which we would wish to adopt in NHS Wales: A SI requiring investigation is defined as an incident that occurred in relation to NHS. funded services and care resulting in: the unexpected or avoidable death of one or more patients, staff, visitors or members of the public;. permanent harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention or major surgical/medical intervention or will shorten life expectancy (this includes incidents graded under the NPSA definition of severe harm).

4 A scenario that prevents or threatens to prevent an organisation's ability to continue to deliver health care services, for example, actual or potential loss or damage to property, reputation or the environment;. a person suffering from abuse;. adverse media coverage or public concern for the organisation or the wider NHS;. the core set of Never events' as updated on an annual basis. For 2010/11 this includes:- wrong site surgery retained instrument post-operation 1. wrong route administration of chemotherapy misplaced naso-gastric or orogastric tube not detected prior to use inpatient suicide using non-collapsible rails escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners in-hospital maternal death from post-partum haemorrhage after elective caesarean section intravenous administration of mis-selected concentrated potassium chloride Reporting arrangements for Reporting serious incidents and other concerns/no surprises to the Welsh Assembly Government Since April 2010.

5 All serious incidents or no surprises (sensitive issues) have been reported, electronically, to the Improving Patient Safety Team Mailbox at the Assembly Government . NHS Organisations are now required to: Complete a revised SI notification form ( form 1) for the Reporting of all serious incidents (attached at appendix 1) or complete form 2 for the Reporting of no surprises (attached at appendix 2). Please note the forms are protected so that the title of the form and the text prompt boxes can not be altered. The field boxes in bold that are completely grey are for Welsh Assembly Government use only.

6 Ensure that the notification form provides as much information as is available. However, please ensure at all times that there are no patient or staff identifiable details ( patient name, dates of birth, home address, staff names etc);. Send the completed notification form to within 24 hours of the incident ;. Password protect each notification form ;. Ensure that each notification form is signed off by the CEO or an Executive Director. An electronic signature should be attached to the form . Please note: Notification forms will be sent back to the organisation if there is no executive sign off or if it is not password protected.

7 Within 24 hours of receipt, the Assembly Government will respond to the notification by returning an electronic copy of the SI form which will confirm: The initial grading of the incident which will indicate the timescale of investigation (as defined below); and, The Assembly Government reference number, which will be the number used in all future correspondence relating to the incident . For incidents that potentially may attract national or significant media attention, please immediately contact a member of the Improving Patient Safety Team (IPST), who will liaise with the Assembly Government Press Office.

8 Appendix 3 indicates the contacts 2. detail of Assembly Government officials within the IPST for your organisations. Direct contact should only be made with the Assembly Government Press Office out of usual working hours. The out-of-hours press office number is 029 2089 8099 and the answer phone will give the contact number of the duty press officer. Grading of incidents The initial grading of a SI is undertaken on a case by case basis and will clarify the level of investigation required and monitoring approach by the Assembly Government . All incidents submitted to the Assembly Government are reviewed on a weekly basis.

9 If during these review meetings it is decided that the initial grading is inappropriate, it will be revised and you will be informed of this change, plus any further action or information that we may require. Should an organisation wish to discuss the grading assigned to an incident they should contact the relevant Assembly Government official (as shown on appendix 3). A table summarising the grading, expected response and timescales is attached at appendix 4. This has been adapted to suit the Wales context from the NPSA National Framework for Reporting and learning from serious incidents Requiring Investigation.

10 It is expected that the level of investigation is consistent with the triggers and levels of RCA investigation published by NPSA (see appendix 5). Definitions of grading Grade 0. Concerns currently and commonly referred to as a no surprise' and/or where it is initially unclear whether a serious incident has occurred will be graded 0. Unless further information is received, Assembly Government will automatically close the incident after 3. days and no further correspondence with the Assembly Government is required. However organisations will wish to assure themselves of a proportionate and appropriate response and ensure arrangements are in place to reduce the risk of re-occurrence.