Proposal for ROCR Approval 1. Record Type? New 2. Unique Number R01036 3. Title National Emergency Laparotomy Audit 4. Collection Type National 5. Other Reference 6. Description The National Emergency Laparotomy Audit (NELA) is part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP), overseen by the Healthcare Quality Improvement Partnership (HQIP). NCAPOP is a closely linked set of centrally-funded national clinical audit projects that collect data on compliance with evidence based standards, and provide local trusts with benchmarked reports on the compliance and performance. They also measure and report patient outcomes. NELA was commissioned following evidence of a high incidence of death, and a wide variation in the provision of care and mortality, for patients undergoing emergency laparotomy in hospitals across England, Wales and Scotland. The aim of the audit is to enable the improvement of the quality of care for patients undergoing emergency laparotomy through the provision of high quality comparative data from all providers of emergency laparotomy. The contract for the provision of the NELA was awarded to the Royal College of Anaesthetists (RCoA) in June 2012. The Clinical Effectiveness Unit of the Royal College of Surgeons of England and the Intensive Care National Audit & Research Centre are partners and provide important methodological and technical input. The NELA is currently funded for 3 years with the potential of a further 2 year extension. Proposal for ROCR Approval The contract commenced in December 2012 with an organisational audit performed in year 1. Individual patient data collection commenced in Year 2 and 3 (Dec 2013-Nov 2015), with the potential for funding to be extended until 2017. All patients aged 18 and over, having a general surgical emergency laparotomy in all NHS hospitals in England and Wales will be enrolled on a prospective basis. NELA will look at structure, process and risk-adjusted outcome measures for the quality of care received by patients undergoing emergency laparotomy. NELA will compare against standards of care such as those detailed in recent NCEPOD reports, and the Department of Health/Royal College of Surgeons of England’s “Higher Risk General Surgical Patient (2011)” The aim of the audit is to generate data that drives Quality Improvement (QI). QI will be facilitated through dissemination of collected data as well as workshops and seminars to drive specific QI projects alongside data collection. NELA data will be linked to other sources of routine data including Critical Care Data (Intensive Care National Audit and Research Centre (ICNARC) case mix programme), Bowel Cancer Data (National Bowel Cancer Audit/Upper Gastro-intestinal Cancer Audit) and Hospital Episode Statistics (mortality data). NELA will be delivered by a central project team from the National Institute of Academic Anaesthesia’s Health Services Research Centre based at the RCoA. Formal oversight will be provided by a Project Board consisting of key stakeholders. Scientific input will be provided by a Clinical Reference Group consisting of representatives from all relevant clinical professional and specialty stakeholders (including patient groups). 7. State Submitted to ROCR 8. ROCR Reference No SCCI2057 9. Start Date 01/12/2013 Proposal for ROCR Approval 10. End Date 30/11/2015 11. FT Collection Type MANDATORY 12. Collection Type MANDATORY 13. Owning Organisation Royal College of Anaesthetists 14. Owning Department Research 15. Owner Name and Contact Details Name: Jose Lourtie Email: jlourtie@rcoa.ac.uk Tel No: 020 7092 1683 Location: London 16. Senior Supporting Official Name Dr Dave Murray 17. Senior Supporting Official Contact Details Title: Dr Tel No: 01642 854600 Email: dave.murray@stees.nhs.uk Location: James Cook University Hospital, Middlesbrough 18. Data Provider Burden Days 1502.67 Proposal for ROCR Approval 18. Data Provider Burden £ £ 668106.51 18. Frequency Ad-Hoc 18. Source Organisations (Number of orgs) Acute Foundation Trust (88) , Acute Non Foundation Trust (59) 19. Set Up Costs £0 20. Other Costs £ 1039031 21. Total Costs £ 1707137.51 22. Please explain the reason for any increase or decrease in burden and provide details of the any other costs figure provided in Q20 n/a 23. Benefits to Patients and the NHS Benefits include: - To enable secondary care providers to improve the delivery of care to patients undergoing emergency laparotomy using information produced by the audit. - To provide comparative information on the organisation of care by providers of Emergency Laparotomy. - To provide comparative information on Proposal for ROCR Approval patient outcomes following surgery for Emergency Laparotomy. - To facilitate the development of effective change (quality improvement) initiatives and thereby spread examples of best practice and help local providers make the best possible use of audit results. - To explore the potential for Patient Reported Outcome Measures to be included in the Programme if and when appropriate tools / collections become available. Mortality from emergency laparotomy has remained high for many years and emergency surgery has been an underfunded and under resourced specialty. National data of high quality will support the argument for investment and allow us to track high and low performing centres in order to learn from the former and help support the latter. With morbidity and mortality so high, even small amounts of improvement will save a significant numbers of lives. 24. Financial benefits to running this collection The annual cost of emergency laparotomy care has been estimated at ~£650 million. (Shapter Anaesthesia 2012, 67, 474–478), of which ~75% represents ward/critical care costs. Improvement in care would be expected to reduce this. Even a 1 day reduction in length of stay would be expected to save ~£20 million. 25. Publication methods NELA is on the list of national audits for inclusion in Trusts' Quality Accounts. NELA will issue annual reports that will include key outcome data, at named hospital level. NELA will also provide comments on whether relevant standards are being met. A Public & Patient guide will be made available to accompany the Annual reports. There will be the capability for Hospitals to access their own data through an online web tool. This data can be exported at any time by the local NELA leads and be used to quality improve service. 26. Publication http://nela.org.uk/NELA_home Proposal for ROCR Approval Links 27. Requesting Organisation Royal College of Anaesthetists 28. Collection Method Web based collection 29. NHS Mandate Commitment -Helping people to recover from episodes of ill health or following injury -Preventing people from dying prematurely -Ensuring that people have a positive experience of care -Treating and caring for people in a safe environment and protecting them from harm 30. Changes since last assessment 31. Data in operational systems Yes 32. Plans for collecting this data from operational systems 33. If the data was not collected, what would the consequences be This audit forms part of the HQIP NCAPOP audit programme. Hospitals would be unable to participate in a mandated NHS audit The NHS standard contract requires that organisations providing NHS care must participate in all relevant NCAPOP audits and enquiries. NCAPOP audits and enquiries are those commissioned by HQIP. If providers do not participate in relevant NCAPOP audits they will be in breach of their contract with their commissioner, therefore any non-participation would need to be agreed with the Proposal for ROCR Approval commissioner and CQC as the regulator. NELA data will be linked to other sources of routine data including Critical Care Data (Intensive Care National Audit and Research Centre (ICNARC) case mix programme), Bowel Cancer Data (National Bowel Cancer Audit/Upper Gastro-intestinal Cancer Audit) and Hospital Episode Statistics (mortality data). 34. Is there an impact assessment or business case for this collection? If so please attach No 35. Process required for others to go through to obtain the data The aim of the audit is to generate comparative information that drives Quality Improvement (QI). QI will be facilitated through dissemination of collected data as well as workshops and seminars to drive specific QI projects alongside data collection. Individual hospitals participating in the audit have access through the online web tool to their own data when required. They are able to export a full list of their completed patient cases and so they may use their audit data to support local quality improvement initiatives. There is also a process by which others can link to the NELA data collected. This would be by going through the HQIP data sharing agreement process. 36. Keywords emergency laparotomy 37. National / Official statistic NA 38. Method used to store the data How will data be protected? The server is hosted by UKFast in a secure datacentre. All traffic passes through Cisco equipment including Anomaly Detection Proposal for ROCR Approval Systems (ADS), Intrusion Detection Systems (IDS) and Intrusion Prevention Systems (IPS). This is clustered across multiple locations. The hardware is protected by a Cisco Firewall with full access controls enabled. UKFast carry out annual security audits as standard within the terms of the contract. These audits will inspect the system for any vulnerabilities or threats that could allow hackers to destroy or damage the system. Each UKFast datacentre is fully powered, secure, resilient and equipped to meet the project demands. The company has a track record in delivering to many private and public sector clients including the NHS and has demonstrated a strong awareness of the need to protect systems and data from both physical and virtual threats. UKFast has attained ISO-27001:2005 certification for their Information Security Management System and ISO 9001:2008 for their Quality Management System. They are PCI compliant for all client transactions. 1. System Security - Full Security patching; - Dedicated firewall; - Risk assessment and security consultation and auditing; - Programmed evaluation and testing of all systems; 2. Physical and site security - Unassuming facilities, unmarked and inauspicious; - On site security 24/7/365; - Electronic surveillance with continual monitoring/recording; - Electronic access; Client access by appointment only; - Dual power supply, UPS and onsite generator backup; - Fire, power, weather, temperature and humidity monitoring systems; - Diverse fibre routing via multiple carriers; Cross connection to a number of tier 1 carriers; - 24 hour security patrol (NSI accredited security). 39. Why sampling is not used The agreed contract with HQIP is to collect data from all providers of care as this was identified as the most appropriate method of bringing about the required Quality Improvements 40. Details of any pilots Both the organisational audit and patient audit underwent extensive pilot testing. Using local hospital Proposal for ROCR Approval participants to feedback on audit data collection process, questions and All relevant clinical professional and speciality stakeholders will have direct input into the design and conduct of this audit. This will be achieved through the Clinical Reference Group that consists of representatives from partner organisations as well as other stakeholders including patients. The CRG will act in an advisory capacity to the Project Team, providing specialty specific advice, and lay advice as appropriate. The CRG will review the audit design regularly and will also review drafts of any reports and recommendations issued. 41. Equalities dimensions used in the collection Age/Date of Birth, Gender 42. Policy that the collection supports N/A 43. IG Data type Patient identifiable