Meeting of Bristol Clinical Commissioning Group Governing Body. Title: Bristol CCG Management of Serious Incidents Agenda Item: 17

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Meeting of Bristol Clinical Commissioning Group Governing Body To be held on Tuesday 22 December 2015 commencing at 13:30 at the Greenway Centre, Doncaster Road, Bristol, BS10 5PY Title: Bristol CCG Management of Serious Incidents Agenda Item: 17 1 Purpose The purpose of this paper is to describe for the Governing Body the approach taken by Bristol CCG Quality team to manage serious incidents (SIs) that are identified and reported to Bristol CCG as part of the SI Assurance Framework by provider organisations. The paper will also include a comparison of numbers of SIs submitted by providers and provide some examples of learning. 2 Background In March 2015 NHS England published the revised Serious Incident Framework. This framework builds on previous guidance and replaces the National Patient Safety Agency (NPSA) National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (2010) and NHS England s Serious Incident Framework (March 2013). https://www.england.nhs.uk/patientsafety/wpcontent/uploads/sites/32/2015/04/serious-incidnt-framwrk-upd2.pdf The revised framework identifies key milestones for completion of notification of the SIs, 72 hour reports, submission of Root Cause Analysis (RCA) reports and action plans, Duty of Candour and completion of review by commissioners. The legal duty of candour was introduced as a direct result of recommendations made by the Francis enquiry into the Mid Staffordshire Hospital Trust and forms part of the standard NHS contract. The requirement is for organisations to be open and transparent with patients and their families (see section 5). Revised guidance for the management of Never Events published in 2015 also guides the process for the reporting and management of these types of serious incidents for both providers and Bristol CCG. https://www.england.nhs.uk/patientsafety/wpcontent/uploads/sites/32/2015/04/never-evnts-pol-framwrk-apr2.pdf Bristol CCG Serious Incident Policy 2015, which is based on the National Serious Incident Framework 2015, outlines the overarching governance arrangements for the management of serious incidents and/or never events. The policy aims to ensure that patient safety and other reportable incidents are appropriately managed within commissioned and contracted NHS services. If you need this document in a different format telephone the CCG on 0117 900 2632 Page 1 of 11

A workshop was held by NHS England (NHSE) in November 2015 to agree a cohesive approach to the management of SIs under the new national framework across all CCGs in the South West of England. 2.1 Provider Organisation process All providers of NHS funded care are contractually bound to report SIs as defined in the national framework to the commissioner. Provider organisations SIs are reported to the CCG via the Strategic Executive Information System (STEIS) which is managed by the Department of Health. The system enables electronic logging, tracking and reporting of Serious Incidents and provides an audit trail for the management of SIs. An open dialogue is maintained with providers so that the provider is able to telephone and discuss incidents with the co-ordinating commissioner as well as utilise the electronic database. 2.2 Primary Care process At the current time all significant Primary Care incidents/events including Serious Incidents are reported to and reviewed by the NHSE Primary Care and Quality teams. NHSE then records all SIs on STEIS. The NHSE teams maintain a significant event analysis (SEA) database to record any SEA reported by primary care. The sharing of SEA data with NHSE is fully established within Devon, Cornwall and Isles of Scilly with General Practitioners (GP) reporting incidents using an SEA form which mirrors the fields on the STEIS database. There are plans to roll this process out to GP practices in Bristol, North Somerset, Somerset and South Gloucestershire by NHSE. This work will be aligned with the work underway by the Patient Safety Collaborative (PSC) team supported by the West of England Academic Science Health Network looking at reporting all incidents in primary care and not just SIs. Bristol CCG is part of the PSC work collaborating with other CCGs to develop a Primary Care incident reporting system. The aim of this development is to move from a reactive to a generative culture of learning to improve the quality of primary care services and reduce avoidable harm. Plans for the future roll out of the management of primary care SIs to CCGs sits within the co-commissioning agenda. 3 SI Review Closure Panel Bristol CCG has set up an SI Review Closure Panel that meets fortnightly to ensure that all SIs are reviewed by commissioners within the national stipulated 20 calendar day timeframe. This panel reviews SIs that occur within CCG commissioned provider services. The SI Review Closure panel membership consists of representatives from the quality team, specialist experts including safeguarding leads for children & adults, medicines management, mental health and NHS England. GP leads are also invited to both comment on submitted root cause analysis (RCA) reports and participate in the discussion of the SI at panel meetings. The role of the SI Review Closure panel is to review and sign off all 72 hour reports, RCA reports, action plans, and requests for removal of incidents from STEIS where further investigation by the provider has identified that the incident Page 2 of 11

does not fall into the category of being a serious incident. All meetings are minuted and an action log is reviewed and updated at each meeting. 4 RCA Checklist and Feedback RCA investigation reports are allocated to members of the Quality team to undertake an initial review using an RCA closure checklist (Appendix 1). The RCA closure checklist aids the discussion at the panel meeting. Following the panel discussion the checklist is amended and returned as feedback to the relevant provider. Bristol CCG will include any requests for additional assurance, arising from the review of the RCA report within the RCA checklist and these requests are also logged in STEIS. 5 Duty of Candour The Duty of Candour is a legal duty on provider organisations to be open and transparent and apologise to patients if there have been mistakes in their care that have led to significant harm. The CCG looks for assurance within the RCA report that the provider has been open and transparent with the patient and their family (if appropriate) and fulfilled this duty. Additionally duties of candour audits, through the review of patient notes, provide the evidence of completion of duty of candour and are carried out on a quarterly basis. If the duty of candour is not fulfilled the provider is subject to a 10,000 penalty per omission. 6 Specialised Commissioning A joint approach is undertaken with NHS England (NHSE) to manage SIs that fall under the remit of specialised commissioned services. The CCG alerts NHSE to all notifications of SIs concerning these services. A member of the NHSE quality team is invited to the Bristol CCG RCA closure panel meeting to participate in the discussion of the relevant SI. Any action undertaken including removal from STEIS, closure of incidents, etc. for SIs involving specialised commissioned services is approved and completed by NHSE. 7 Incidents Requiring Joint Monitoring Under the national Serious Incident Framework, Never Events, Homicides and Public Interest SIs are overseen by NHSE.. As with specialised commissioned services a collaborative approach is undertaken and closure of the incident on STEIS is approved by NHSE. As with SIs, Never Events are tracked and monitored by the CCG quality team (see section 8). Never events are seen as being wholly preventable and as such financial penalties are attributed to Never Events through the NHS Contract 8 SI Monitoring The Bristol CCG quality team maintain a database to record and track provider and CCG performance for notification and submission of RCA reports and action plans against the requirements of the national Serious Incident Framework. The quality team also tracks and monitors all requests and responses for further assurance from providers. Page 3 of 11

A quarterly report is presented to the Quality & Governance committee that shows the percentage and numbers of SIs reported and reviewed against the key milestones. The report also identifies themes, trends and quality issues. Information is shared with providers through the integrated quality and performance meetings (IQPM). At each monthly IQPM with providers, the SI performance is presented and discussed to ensure that any issues including identified trends are actioned. 8.1 Learning from SIs Opportunities for learning arise from the review of the RCA and action plan s submitted by provider organisations including the identification of key themes and trends over a period of time. Examples of learning arising from the review of RCA s include: Development of the pan Bristol Stop the Pressure Steering Group to share learning across organisations. This work will include the completion of a gap analysis of SI action plans to reduce the incidence of pressure ulcers and reduce harm to patients. The Bristol CCG Medicines Management Team are working with BCH to review and revise their medication chart to reduce medication errors Development of a workshop to address key learning identified from review of SIs that will produce a consistent approach to SI management for the Trust. The tables below show the SIs including Never Events for 2013 /2014, 2014/2015 and 2015/2016 by provider University Hospitals Bristol (UHB) Year Apr May June July August Septembe r October November December January February March Total 2013/2014 6 2 12 9 3 4 7 5 7 6 10 5 76 2014/2015 6 8 5 9 3 7 10 7 8 8 5 7 83 2015/2016 6 6 4 3 9 4 3 35 SIs reported by UHB increased by 9% in 2014/15 when compared to 2013/14. 2015/16 is currently showing a 27% decrease in SIs reported to October 2015 when compared to the same period in 2014/15. The top 2 SI reported by UHB across all years to date are pressure ulcers and slips, trips and falls. The trend data is showing that there is a small decrease in numbers of reported incidents for these categories. UHB is participating in the pan Bristol Stop the Pressure group to reduce the incidence of pressure ulcers. Page 4 of 11

North Bristol Trust Year Apr May June July August September October November December January February March Total 2013/2014 14 13 11 15 12 4 12 13 5 6 2 6 113 2014/2015 10 2 3 9 15 7 12 9 9 7 6 4 93 2015/2016 5 9 2 10 4 9 3 42 SIs reported by NBT decreased by 17% in 2014/15 when compared to 2013/14. 2015/16 is currently showing a 28% decrease in SIs reported to October 2015 when compared to the same period in 2014/15. The top 2 SIs reported by NBT across all years to date are pressure ulcers and slips, trips and falls. The trend data is showing that there is a decrease in numbers of reported incidents for pressure ulcers, whereas the percentage of reported slips, trips and falls have steadily increased. NBT is participating in the pan Bristol Stop the Pressure Steering group. Bristol Community Health Year Apr May June July August September October November December January February March Total 2013/2014 2 5 1 3 3 3 0 3 1 2 0 0 23 2014/2015 3 1 2 1 6 0 3 3 7 3 5 5 39 2015/2016 6 4 5 7 2 6 7 37 SIs reported by BCH increased by 68% in 2014/15 when compared to 2013/14. 2015/16 is currently showing a 137% increase in SIs reported to October 2015 when compared to the same period in 2014/15. BCH introduced an electronic incident reporting system this year which has raised awareness amongst staff of the importance of reporting incidents and has contributed to a month on month increase in the number of incidents reported by staff. The top 2 SI reported by BCH across all years to date are Grade 3 and Grade 4 pressure ulcers. The trend data is showing that the percentage of reported grade 3 pressure ulcer SIs is consistent over the period, whereas the percentage of reported grade 4 pressure ulcer SIs is declining, with no Grade 4 reported pressure ulcer SIs reported to date in 2015 / 16. BCH is also participating in the pan Bristol Stop the Pressure Steering group. Page 5 of 11

Avon & Wiltshire Partnership Trust Year Apr May June July August September October November December January February March Total 2013/2014 3 3 6 8 5 1 2 2 2 6 1 3 42 2014/2015 3 2 5 6 1 3 1 1 4 2 1 5 34 2015/2016 2 1 1 1 1 0 1 2 9 Recovery Bristol Partnership (RBP) 2 1 3 3 0 0 2 2 13 SIs reported by AWP decreased by 19% in 2014/15 when compared to 2013/14. Combining the AWP and RBP incidents, 2015/16 is currently showing the same number of SIs reported to October 2015 when compared to the same period in 2014/15. The top SIs reported by AWP across all years to date is unexpected death community patient. The trend data is showing that the numbers of reported unexpected death of community patient SIs is increasing. An independent review of these is being planned. A contract query notice was issued to AWP in August 2015 related to concerns regarding the Trusts quality and governance processes. 8.2 Quality Assurance. Bristol CCG has assured itself of the formal review processes in place in provider organisations to ensure that all identified actions are captured and completed. The CCG assures itself through the internal SI review processes that organisational learning is captured by providers and implemented. All reported SIs and actions taken are monitored through the monthly quality sub groups and IQPMs. The CCG understands the importance of ensuring that organisational learning is embedded to prevent recurrence of the incident. A focus is maintained by the CCG and providers through the IQPM and quality sub group meetings that ensures that identified organisational learning has been embedded into practice for each provider. As previously mentioned Bristol CCG will seek additional assurance from providers as required before agreeing closure of an SI on STEIS. The Duty of Candour audit takes place quarterly to monitor that providers are meeting this legal requirement and financial penalties attributed where omissions are identified. Page 6 of 11

For 2016/2017, the Quality Schedules will include a requirement to enable completion by the CGG of a quarterly audit of 5 SIs randomly selected to check and confirm implementation of actions as well as permitting observational visits by Bristol CCG. 9 How have service users, carers and local people been involved? Not applicable for this update paper, however for each individual incident, patients and their families are informed under the Duty of Candour requirements. 10 Implications on equalities and health inequalities. There are no specific health inequalities issues raised in the paper Please indicate below the age group/s covered by the service/affected by the issue discussed Children/Young People x Adults x 11 Evidence Informed Commissioning The Bristol CCG approach to the reporting and review of SIs is informed by NHS England s National Serious Incident Framework 2015 and Never Event Framework 2015 12 Financial Implications Financial penalties are placed on providers who do not complete Duty of Candour requirements 13 Legal implications There are no legal issues raised in this paper 14 Risk implications, assessment and mitigation The risks associated with the Serious Incidents relate to patient safety risks and CCG performance measures 15 How does this fit with Bristol CCG s Operational Plan or Strategic Objectives? The learning from SIs supports the CCG to improve quality of services provided and reduce avoidable harm to patients 16 Recommendation(s) The Governing Body is asked to Page 7 of 11

1. Note and approve the approach taken by the quality team to manage and review serious incidents as part of the quality assurance framework. 2. Note the plans for the development of a primary care incident reporting system Bridget James Head of Quality 24 November 2015 Alison Moon Transformation & Quality Director 24 November 2015 Glossary of terms and abbreviations DH Duty of Candour IQPM RCA SI Department of Health The Duty of Candour requires providers to be open and transparent with patients and their families when things go wrong including informing them about the incident, providing support, information and an apology Integrated Quality and Performance Meeting is a regular meeting held with providers to hold them to account for the quality and performance of services agreed through the NHS Contract, Quality Schedules and CQUINS Root Cause Analysis is the process undertaken during an investigation of an incident to identify the root cause that led to the incident occurring. Serious incidents requiring investigation are defined by the NHS England Serious Incident framework (2015) as events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant that they warrant using additional resources to mount a comprehensive response which result in: unexpected or avoidable death Unexpected or avoidable injury that requires further treatment by a health professional to prevent death or serious harm actual or allegations of abuse Page 8 of 11

loss of confidence in the service, adverse media coverage or public concern about healthcare or an organisation. STEIS Strategic Executive Information System is owned by the Department of Health. It is the national electronic database where all Serious Incidents and Never Events are logged, reported and tracked. Page 9 of 11

Appendix 1 RCA Checklist STEIS Reference Number Date of Incident Date Incident Reported Date 72 hour report received Date CCG Received RCA report Reporting Organisation Root Cause Analysis Closure Checklist Stage Component Yes / No Set Up / Is the investigative team Preparation membership appropriate to the investigation? Is the scope & level of the incident appropriate? Was the Serious Incident Framework adhered to? Has the Duty of Candour been fulfilled? Gathering & Mapping Was the appropriate evidence used (where it was available) i.e. patients notes/records, written account? Is there evidence that those with an interest were involved (making use of briefings, de-briefings, draft reports etc.)? Is there evidence that those affected (including patients/staff/ victims/ perpetrators and their families) were involved and supported appropriately? Is there a Chronology of events? Is the Chronology Clear? Comment Are good practice guidance and protocols referenced to determine what should have happened? Are care and service delivery problems identified? (This includes what happened that shouldn t have, and what didn t happen that should have. There should be a mix of care (human error) and service (organisational) delivery Page 10 of 11

Analysing Information Generating Solutions Throughout Next Steps problems) Is it clear that the individuals have not been unfairly blamed? (Disciplinary action is only appropriate for acts of wilful harm or wilful neglect) Is there evidence that the contributory factors for each problem have been explored? Is there evidence that the most fundamental issues/ or root causes have been considered? Are the root causes clearly stated Have strong (effective) and targeted recommendations and solutions (targeted towards root causes) been developed? Are actions assigned appropriately? Are the appropriate members i.e. those with budgetary responsibility involved in action plan development? Has an options appraisal been undertaken before final recommendation made? Is there evidence that those affected have been appropriately involved and supported? Is there an action plan to support implementation of change and improvement and method for monitoring? Is further review / input required.e.g. safeguarding, medicines management, Commissioning clinical lead, CSU Are there any links to previous incidents? Consider checking STEIS, Safeguarding, and Internal Records etc. Consider if previous corrective actions were effective Is further information required from the provider? Agreement to Close? Specialist Commissioned Service requiring referral to NHSE for closure? Date Reviewed at Panel Name Date Ref: Serious Incident Framework (NHS England 2015) Page 11 of 11