Document Title Reference Number Lead Officer Author(s) (name and designation) Ratified by Clinical Audit Policy NTW(C)52 Medical Director Prof. Paula Whitty Director of Research, Innovation and Clinical Effectiveness Trust Policy Group Date ratified January 2015 Implementation Date February 2015 Date of full Implementation August 2015 Review Date February 2018 Version number Review and Amendment Log Version Type of change Date V03 Review Feb 15 V03 Description of change Reviewed document; reflecting process changes and internal quality audit This policy supersedes the following document, which must now be destroyed Reference Number NTW(C)52 V02.3 Title Clinical Audit Policy
Clinical Audit Policy Section Contents Page No. 1 Introduction 1 2 Purpose 2 3 Definition of Clinical Audit 3 4 Scope 3 5 Duties Accountabilities and Responsibilities 3 6 The Clinical Audit Process 7 7 Information governance and ethics 13 8 Audit certificate 14 9 Training - Clinical Audit resources 14 10 Identification of Stakeholders 15 11 Equality Impact assessment 15 12 Implementation 15 13 Monitoring compliance and effectiveness 15 14 Standards / Key Performance Indicators 16 15 Fair Blame 16 16 Associated documentation 16 17 References 16 Standard Appendices attached to policy document A Equality Impact Assessment tool 17 B Communication and Training Needs Information 19 C Monitoring Tool 20 D Policy Notification Record Sheet - click here
Appendices, listed separate to policy Appendix No: Title Issue Issue Date Review Date Appendix 1 Clinical Audit Cycle 1 Feb 15 Feb 18 Appendix 2 Clinical Audit Department Contacts - Updated 3 10 Mar 15 Feb 18 Appendix 3 Appendix 4 Appendix 5 FORM - Clinical Audit Registration & Planning Template - Clinical Audit Report and Action plan Template - Audit Certificate for Clinical Audit Department use only 1 Feb 15 Feb 18 3 Jul 15 Feb 18 1 Feb 15 Feb 18 Appendix 6 Clinical Audit Timeline 1 Feb 15 Feb 18 Appendix 7 Clinical Audit FAQs 1 Feb 15 Feb 18 Practice Guidance notes, listed separate to policy PGN No: Title Issue Issue Date CA-PGN-01 Board Assurance Framework V02 Issue 3 Review Date Nov 16 May 17 Appendix 1 Risk Ratings and Priority Classifications Issue 2 Feb 15 May 17 Appendix 2 Assurance Level to be applied to Reports issue 2 Feb 15 May 17
1 Introduction 1.1 It is the responsibility of all health care professionals to ensure that they are delivering the best possible quality of care to their patients and carers and that this care is evaluated regularly and robustly. Northumberland, Tyne and Wear NHS Foundation Trust (the Trust/NTW) are fully committed to delivering effective clinical audit as a means of developing and maintaining high quality and safe patient-centred services and this policy has been developed to ensure that the correct processes are followed by all staff who participates in clinical audit activities. 1.2 The expectation for healthcare professionals to participate in regular clinical audit was first established in the 1989 Government White Paper, Working for Patients. This has been reinforced and extended by a succession of key national publications, including: Learning from Bristol: the report of the public inquiry into children s heart surgery at Bristol Royal Infirmary 1984 1995 [the Kennedy Report (Department of Health, 2002) The Health & Social Care Act (2008) The NHS Next Stage Review Final Report, High Quality Care for All The Darzi Report, (Department of Health, 2008). Health Act (2009) The NHS (Quality Accounts) Regulations (2010) Care Quality Commission Guidance about compliance: Essential Standards of Quality and Safety (2010) The NHS Litigation Authority (NHSLA) Clinical Negligence Scheme for Trusts (CNST) Risk Management Standards for NHS Trusts (2012-2013) NHS England (formerly the NHS Commissioning Board Monitor NHS Foundation Trust Annual Reporting Manual (2012/13) 1.3 Since the creation of Standards for Better Health by the Department of Health between 2004 and 2009, all NHS Trusts have had to make an annual Declaration including their compliance with Standard C5d, which states that Healthcare organisations [must] ensure that clinicians participate in regular clinical audit and reviews of clinical services. 1.4 Furthermore, in 2008, the Healthcare Commission introduced an engagement in clinical audits indicator which places the following expectations on NHS Trusts: To participate in local and/or national audits of the treatment and outcomes for patients in each clinical directorate covered by the Trust Northumberland, Tyne and Wear NHS Foundation Trust 1
To have a clinical audit strategy and programme related to both local and national priorities with the overall main aim of improving patient outcomes To make available suitable training, awareness or support programmes to all clinicians regarding the Trust's systems and arrangements for participating in clinical audit To ensure that all clinicians and other relevant staff conducting and/or managing clinical audits are given appropriate time, knowledge and skills to facilitate the successful completion of the audit cycle To undertake a formal review of the local and national audit programme undertaken in the Trust to ensure that it meets the organisations aims and objectives as part of the wider quality improvement agenda To provide the Trust's management and governance leads with regular reports on the progress being made in implementing the outcomes of national clinical audits, and review the outcomes, with additional or re- audits being conducted where necessary 1.5 More recently, the Care Quality Commission (CQC) has published the essential standards of quality and safety which consists of 28 regulations (and associated outcomes) that are set out in two pieces of legislation: the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. It is clear that clinical audit is viewed as a reliable and robust methodology for providing assurance against these outcomes. 1.6 This policy has been updated with reference to the Enhanced Clinical Audit Process agreed at SMT in November 2013. 2 Purpose 2.1 This policy sets out the approval, reporting and monitoring framework for all clinical audits carried out within the Trust. 2.2 This policy sets out the Trust s principles in relation to the conduct of all clinical staff fulfilling their obligations to participate in clinical audit, and the processes to be complied with to ensure that audit is undertaken effectively and their obligation to do so as part of the Trust s accountability to the Care Quality Commission Essential Standards of Quality and Safety and the government requirement that all clinicians participate in regular clinical audit (core standard 5d). For the purposes of this policy, regular is defined as annually. 2.3 The policy outlines the process that should be followed when developing and planning a clinical audit. Northumberland, Tyne and Wear NHS Foundation Trust 2
3 Definition of Clinical Audit 3.1 Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change (see Appendix 1). Aspects of the structure, process and outcomes of care are selected and systematically evaluated against criteria. Where indicated, changes are implemented at an individual team or service level, and the audit is repeated to see if the quality of patient care has improved (National Institute for Health and Care Excellence NICE 2002). 4 Scope 4.1 Clinical audit compares actual practice against documented evidence-based standards with the intention of improving the quality of care. Within the Trust this process underpins several quality improvement areas, for example managing risk, clinical governance, benchmarking against national and local standards, quality indicators for commissioned contracts, practice development and staff development. Indeed, clinical audit activity is included in the Trust s provider contracts, and the Trust is monitored on our performance against these targets. 5 Duties, Accountabilities and responsibilities 5.1 This policy applies to all clinical personnel within the Trust and to anyone engaged in the clinical audit process under the auspices of the organisation, so this will include students, volunteers and patients. 5.2 For the purposes of this policy, clinician is defined as any person who has clinical contact with patients i.e. Medical staff, Nursing staff, Pharmacists, Psychologists, Allied Health Professionals (AHPs). It is recommended that clinical audit is written into all clinical personnel job descriptions as an area of key responsibility. 5.3 The Clinical Effectiveness Committee 5.3.1 The Clinical Effectiveness Committee (CEC) is the corporate group tasked with overseeing the Trust s clinical audit activities. This includes reviewing this policy and scrutinising the Trust Annual Clinical Audit Plan. 5.3.2 The CEC will ensure that the Trust Annual Clinical Audit Plan includes clinical audits that provide assurance on NICE guidance. 5.3.3 Once this is done both the policy and plan are then sent to the Trust Quality and Performance Committee (Q&P) for formal approval (see timeline, Appendix 6). 5.3.4 The Clinical Effectiveness Committee receives a minimum of quarterly reporting on audit activity and progress against the Trust Annual Clinical Audit Programme. Northumberland, Tyne and Wear NHS Foundation Trust 3
Northumberland, Tyne and Wear NHS Foundation Trust 4 NTW(C)52 5.3.5 The Annual Clinical Audit Plan defines Trust priorities for clinical audit and is agreed at the beginning of each financial year. 5.3.6 The Trust Annual Clinical Audit Programme is a collation of all audit activity to be undertaken during the year. This includes outstanding clinical audits brought forward from the previous year, priority audits identified in the approved Annual Plan, and may include additional clinical audits identified and approved during the year due to changing priorities and risks etc. including NICE standards. 5.4 Group Quality and Performance (Q&P) Committees 5.4.1 All audit activity within the Groups will be overseen by the appropriate Group Q&P. In respect of Medicines Management the responsibility lies with the Medicines Management Committee. 5.4.2 This includes scrutinising and approving Group Annual Plans and monitoring progress against their Annual Programmes as well as ensuring that action plans produced from clinical audits are monitored and completed. 5.4.3 Group Q & P committees should have a regular agenda item for clinical audit. 5.5 Director for Research Innovation and Clinical Effectiveness 5.5.1 The Director for Research Innovation and Clinical Effectiveness will oversee the progress of the Annual Plan through Chairing the Trust Clinical Effectiveness Committee. 5.6 Senior Manager for Research Innovation and Clinical Effectiveness 5.6.1 The Senior Manager for Research Innovation and Clinical Effectiveness will lead the Clinical Audit Department and ensure delivery of the Trust Clinical Audit Plan. 5.7 Clinical Audit Manager 5.7.1 The Clinical Audit Manager will manage the Clinical Audit Team and ensure departmental responsibilities are met including supporting the Trust in: The annual planning exercise of the forthcoming year to ensure Annual Plans are approved and in place Ensuring all clinical audits are approved at Trust and Group level, to align them with National, NICE, Trust and Group clinical audit priorities before they are registered Providing progress reports against the Trust Annual Programme to the Clinical Effectiveness Committee Providing progress reports against Annual Programmes to Trust and Group Q & P Committees Attending Group Quality and Performance (Q&P) Committee meetings on a regular basis to support the monitoring of Annual Programmes and action plans Providing clinical audit training to NTW staff as required
5.8 Clinical Effectiveness Manager 5.8.1 The Clinical Effectiveness Manager will ensure NICE guidance responsibilities are met including supporting the Trust in: The annual planning exercise to ensure that the Trust Annual Clinical Audit Plan includes clinical audits that provide assurance on NICE guidance Providing details on NICE guidance for consideration in respect of clinical audit possibilities to the Clinical Effectiveness Committee Ensuring the Clinical Audit Department is kept appraised of all additional (in-year) NICE guidance agreed as requiring a post baseline clinical audit 5.9 Clinical Audit Facilitators 5.9.1 The Clinical Audit Facilitators (CAFs) will assist with the planning stages of the Annual Plans and the collation of the Annual Programmes, acting as a resource for advice and information on clinical audit and, as appropriate: Providing training at department/ward level in clinical audit awareness, processes and tools Providing information on existing audit tools/assistance with developing new tools Ensuring audits are completed, action plans are logged and progress reported Facilitate the production of reports for Group Q&Ps on relevant audit programmes Subject to resource availability, and as prioritised by the Clinical Audit Manager, CAFs will provide support to some priority audits within the Trust and Group Clinical Audit Programmes 5.10 Group Support Officer 5.10.1 The Group Support Officer facilitates the clinical audit approval and monitoring process in the Groups through close liaison with the Clinical Audit Department and the relevant Group senior clinicians/managers. Northumberland, Tyne and Wear NHS Foundation Trust 5
5.11 Audit Lead 5.11.1 The Audit Lead will be responsible for the planning, timeliness, accuracy and reporting of the clinical audit. They will be required to: Gain Caldicott approval (if necessary) for the clinical audit to be carried out Complete a quality review of the data analysis to ensure the accuracy of findings (if they did not carry out the data collection and analysis themselves) Present a report on the outcomes of the audit to a predetermined forum Ensure the report includes an action plan which identifies key risks, recommendations for improvement and agreed action points to be completed by whom and by a set date (if no action is deemed necessary then the reason for this omission must be reflected in the report) 5.12 Audit Sponsor 5.12.1 The Audit Sponsor (Clinical Lead) should be in a role where they can lead change and make improvements to services and procedures. They will be a senior manager in the service being audited. They will be required to: Ensure a quality review of the data analysis has been completed by an independent party of sufficient knowledge to understand the outcomes of the review and to ensure the accuracy of findings (they may carry out the quality review themselves) Provide responses (agreed action points to be completed by whom and by a set date) to the key risks and recommendations for improvement identified in the action plan Escalate medium and high risks found to the appropriate body of the Trust Report on progress against the action plan to the predetermined forum and ensure it is fully completed 6 The Clinical Audit Process 6.1 This process aims to ensure that all clinical audit projects provide a sound rationale, reflect the business of the organisation and meet the necessary criteria for inclusion in the Trust or Group (including Service Level) audit programmes. Northumberland, Tyne and Wear NHS Foundation Trust 6
6.2 Setting the Priorities for Audit 6.2.1 The Trust will set annual audit priorities based on both internal and external requirements. These will be proposed at, and agreed by the Trust Quality and Performance Committee prior to the start of the financial year (see timeline in Appendix 6). Audits will be prioritised and agreed based on the availability of resources and current priorities, indicatively: Care Quality Commission (CQC) The National Patient Safety Agency (NPSA) CQUINs National Institute of Health and Care Excellence (NICE) Royal Colleges Board Assurance Framework Trust Priorities Group Priorities Local Audits 6.2.2 The plan will be published in the form of a Trust Annual Clinical Audit Plan after agreement at Trust Quality and Performance Committee (see timeline in Appendix 6). 6.2.3 The Trust Annual Clinical Audit Plan will form part of the Trust Annual Clinical Audit Programme. Similarly the Group Annual Clinical Audit Plans will form part of the Group Annual Clinical Audit Programmes. 6.2.4 Clinical audits which are identified as part of the Board Assurance Framework will be subject to a separate process of monitoring and reporting to meet the BAF requirements. This is described in practice guidance note which sits with this policy, CA-PGN-01 - Board Assurance Framework and Audit Process. 6.3 Approval Process 6.3.1 All clinical audit topics must be formally approved at Trust or Group level and be identified on an Annual Programme before they are formally registered with the Clinical Audit Department. Approval status forms part of the quality review of the registration form carried out by the Clinical Audit Department before audits are registered and placed on the clinical audit database. 6.3.2 Clinical Audits that have been approved and identified on an Annual Plan will be automatically registered on the clinical audit database upon receipt of a fully completed registration form. 6.3.3 In-year additions to the Trust and Group Annual Programmes must be approved at Trust/Group Q&P (or a sub-group), before they are registered with the Clinical Audit Department. Northumberland, Tyne and Wear NHS Foundation Trust 7
6.3.4 The Clinical Audit Registration Form should be completed and submitted electronically to the Clinical Audit Department at the earliest opportunity (the registration form can be found on the Clinical Audit pages of the Intranet, see Appendix 3). 6.3.5 Audit registrations which are submitted to directly to Clinical Audit that have not been formally approved will be forwarded to the Groups through the relevant Group Support Officer. 6.3.6 GSOs are not responsible for the quality review of the registration form. 6.3.7 GSOs will provide the Clinical Audit Department with formal notification of all additions to their programme after approval at the relevant Q&P committee meeting. 6.4 Audit Registration 6.4.1 The process of registration requires the Audit Lead to submit an audit registration and planning form (available on the Trust intranet, see Appendix 3) to the Clinical Audit Department in electronic form. 6.4.2 The registration form is an important planning document and should assist the lead in formulating a high quality audit and in planning and implementing changes arising from it. Planning should include consideration on whether the audit will deliver an assessment of compliance against standards or an assessment on if systems/controls are in place to provide assurance to the Trust, or both. 6.4.3 The form consists of four sections, all of which must be completed in order to register an audit. 6.4.4 Support from the Clinical Audit Team can be requested at every stage of the registration process, advice is available on all aspects of the audit cycle including: Sample selection criteria Formulating standards Piloting the audit Information on previous audits carried out on the same topic Some direct support with data collection and analysis may be available subject to availability of resources (priority given to Trust Annual Programme) 6.4.5 All registered audits are added to the clinical audit database for monitoring purposes and current templates for report writing and action planning are sent to Audit Leads with the Registration Confirmation letter (templates are available on the Trust Intranet). Northumberland, Tyne and Wear NHS Foundation Trust 8
6.4.6 The Clinical Audit Department will remain in contact with the Audit Lead in order to monitor the progress of the review and report on if it is being completed within agreed timescales. 6.4.7 Before deciding on and designing an audit project it is essential to discuss audit topics with relevant parties at Service, Line Management and Group level as well as with the Trust s Clinical Audit Department. 6.4.8 Local Audits that are not approved at Service level will not progress to Group level as experience has shown that some audit proposals are duplicating work already being carried out within a service. 6.5 Audit Conduct 6.5.1 Although clinical audit does not require approval from a research ethics committee, the dignity, rights, safety and well-being of participants must be the primary consideration. All projects must comply with: Caldicott principles (1997) Data Protection Act (1998) Freedom of Information Act (2000) NHS confidentiality code of practice (2003) 6.5.2 Normally a clinical audit should not gather any personally identifying information (e.g. name, date of birth, address) and should safeguard the anonymity of service users and staff (when appropriate*) at all times. The staff member proposing or leading the audit should refer proposals to the Caldicott Guardian to establish if approval is required for access to patient records when this is outside their normal clinical practice. * If a clinical audit identifies unsafe clinical practice, as a responsibility of the organisation s duty of care, it will be necessary to identify individuals or teams and bring this to the attention of the relevant Clinical Director. 6.5.3 Before beginning an audit, there should be a commitment from all stakeholders that any changes identified from the audit will be implemented. For this reason, as part of the process it is important to obtain a senior clinical manager s sponsorship for the project (as Audit Sponsor Clinical Lead), particularly if the anticipated outcome of a clinical audit project raises resource implications. 6.5.4 The Audit Sponsor should nominate an Audit Lead who is responsible for registering the project, leading its planning, defining resource requirements and allocating resource to complete the audit. 6.5.5 The Audit Sponsor is responsible for providing assurance that the audit work is of a high standard and that Caldicott approval was obtained (if required). Northumberland, Tyne and Wear NHS Foundation Trust 9
6.6 Ensuring High Quality Audits 6.6.1 Audit Leads, in respect of registration forms which do not meet requirements, will be asked to revise their proposals or advised that the audit should not be carried out. 6.6.2 If after a period of correspondence, the audit design continues to be considered as below standard by the Clinical Audit Department, and the Audit Lead wishes to progress with the audit, the issue will be referred to the Groups for further action. 6.6.3 Audits which are not registered with the Clinical Audit Department should not be conducted in the Trust. 6.7 Reporting, Making Improvements and Monitoring 6.7.1 In order to ensure organisational learning through clinical audit, it is essential that the reporting of findings and the implementation of action plans is monitored through to completion. 6.7.2 Audits which have assessed compliance against set standards should provide results graded on a traffic light system as shown below: Colour Code Score Grading 90 100% Fully Compliant 80 89% Partially Compliant 0 79% Non Compliant 6.7.3 When an audit project is completed the Audit Lead is responsible for producing a final report including an action plan in the format shown in Appendix 4. The report must (where issues have been found) provide recommendations for making improvements in practice, and include an action plan depicting actions to be taken in response to the recommendations, as well as identifying the person responsible for these actions and a set target date. 6.7.4 The report may be presented in draft form in order for decisions on appropriate action planning to be made and when there is a need for rapid feedback to services for example relating to a patient safety issue. 6.7.5 Action plans should clearly define specific action to be taken in order to improve performance: e.g. the action plan should not state improvements against targets will be made but provide details on how improvements in performance will be achieved. Northumberland, Tyne and Wear NHS Foundation Trust 10
6.7.6 The Audit Sponsor is responsible for seeing that these changes are put into practice, including where appropriate, taking action to ensure resources are made available for identified changes to take place. The Audit Sponsor must also ensure that medium and high risks found are escalated to the appropriate body of the Trust. 6.7.7 Risk ratings are defined within the Trust s policy NTW(O)33 - Risk Management. 6.7.8 Clinical audit reports should always consider if a re-audit is necessary and if so the action plan must contain a timescale for re-auditing to evaluate the improvements. If a re-audit is not considered necessary then the report should state the reasoning behind this decision (these should be added to plan as per timeline in Appendix 6). 6.7.9 The report as a minimum should include the following: 1. Introduction: providing background details on the objectives and scope of the audit, including the specifics of the timing of the audit, the sample criteria and sample period covered 2. Conclusion: a summary of the main outcomes/findings contained in the report and provides the reader with a quick overview of the area reviewed and the recommendations that have been made. Board Assurance reviews should also quote the level of assurance provided by the audit. 3. Action Plan: which includes details of the outcomes/findings and risks, an assessed risk rating for each finding outcome, a management response clearly defining any action to be taken, a responsible officer and target date. 6.7.10 All completed reports and action plans should be submitted to the Clinical Audit Department electronically and will be stored in the Clinical Audit database following presentation at the appropriate monitoring body. Northumberland, Tyne and Wear NHS Foundation Trust 11
6.8 Assurance Level to be applied to Board Assurance Framework Reports An assurance level must be applied to the BAF report that reflects the outcome of the clinical audit (refer to the table below): Assurance Level Control / System Review Compliance Review Full That the system of internal control (i.e. policy and procedure) can be fully evidenced and is designed to meet the objectives of the Trust or NHS standards reviewed. That performance attainment is at a compliance level of 100%, fully meeting all aspects of the internal controls in place or standards reviewed. Significant That there is a generally sound system of control designed to meet the Trust's objectives. There are some design weaknesses or inconsistent application of controls which can put the achievement of Trust objectives or NHS standards at risk. That performance attainment was at a compliance level of 90% to 99% against the internal controls in place / standards reviewed. Limited Weaknesses in the design or inconsistent application of controls can and are likely to put the achievement of Trust objectives or NHS standards at risk. That performance attainment was at a compliance level of 50% to 89% against the internal controls in place/standards reviewed. No Weaknesses in control, or consistent non-compliance with key controls, could result or have resulted in failure to achieve the objectives of the Trust or NHS standards reviewed. That performance attainment was at a compliance level of less than 50% against the internal controls in place/ standards reviewed. Northumberland, Tyne and Wear NHS Foundation Trust 12
6.9 Progress Reporting 6.9.1 The Clinical Audit Department will submit progress reports to Clinical Effectiveness Committee (CEC) meetings, at least every quarter, against the Trust Annual Clinical Audit Programme. Trust action plans submitted to the Clinical Audit Department will be reported in summary to the CEC for review. Any risks identified from Trust clinical audits by CEC will be highlighted to the Trust Quality and Performance Committee for a decision on whether they need be placed on a risk register, escalated to the Audit Committee or otherwise monitored. 6.9.2 The Clinical Audit Department will provide monthly progress reports against the Trust Annual Clinical Audit Programme to the Trust Quality and Performance Committee. The progress report will highlight the current status of all Trust (wide) clinical audits to Q&P for review and monitoring purposes. Any serious risks identified from Trust clinical audits will be considered by Trust Q&P and if necessary highlighted to the Audit Committee. 6.9.3 The Clinical Audit Department will provide monthly progress reports against Group Annual Clinical Audit Programmes to the relevant Group Quality and Performance committees via the Group Support Officers. The progress report will highlight the status of all their clinical audits and identify completed projects to the Groups for review and monitoring purposes. Any serious risks identified from Group clinical audits will be considered by Group Q&P and if necessary escalated to the Trust Q&P Committee. 6.9.4 Progress against action plans will be evidenced through the minutes of the appropriate monitoring body. 7 Information governance and ethics 7.1 Information governance: collection, storage and retention of data and confidentiality 7.1.1 All clinical audit activity must take account of the Data Protection Act (1998) and the Caldicott Principles (1997). This means, for example, that data should be: adequate, relevant and not excessive accurate processed for limited purposes held securely not kept for longer than is necessary. 7.1.2 The Audit Lead will be responsible for ensuring that their clinical audit is conducted in a manner that complies with legislation, guidance and Trust policies relating to confidentiality and data protection. These documents include the Trust s policy, NTW(O)29, Confidentiality, Protecting and Using Personal information, the data protection act 1998 principles; Trust policy NTW(O)36 Data Protection. Northumberland, Tyne and Wear NHS Foundation Trust 13
7.2 Ethics and consent 7.2.1 As highlighted in point 6.5.1 Clinical audits should not require formal approval from a Research Ethics Committee. However, one of the principles underpinning clinical audit is that the process should do good and not do harm. Therefore clinical audit must always be conducted within an ethical framework which should consider the following four principles: There is a benefit to existing or future patients or others that outweighs potential burdens or risks Each patient s right to self-determination is respected Each patient s privacy and confidentiality are preserved The activity is fairly distributed across patient groups (HQIP, 2010) 8 Audit Certificate 8.1 All clinical Audit Leads who have registered their project appropriately will receive a certificate of participation once the final report and action plan is submitted, should they require one (See Appendix 5). Any members of their team who took a significant part in the audit will also be eligible to receive a certificate. 8.2 This certificate can be used to demonstrate participation in clinical audit activity when required for external assessment, accreditation or revalidation. It is also relevant to individuals Knowledge and Skills Framework (KSF). 9 Training - Clinical audit resources (See Appendix B) 9.1 The Trust is committed to providing sufficient resources, involving all clinical staff who should receive local management support where relevant. 9.2 The Clinical Audit Department will also provide suitable training, awareness or support programmes to all clinicians regarding the Trust's systems and arrangements for participating in clinical audit. This can be accessed via the training department or by contacting the Clinical Audit Department directly. 9.3 The Group Quality and Performance committees in partnership with the Clinical Effectiveness Committee will be responsible for ensuring that training needs analysis is carried out within each directorate in relation to the clinical audit policy. 9.4 Levels of training are identified in the training needs analysis and are included within the Training Guide which can be accessed via this link http://nww1.ntw.nhs.uk/services/index.php?id=3796&p=2780 Northumberland, Tyne and Wear NHS Foundation Trust 14
10 Identification of Stakeholders 10.1 This existing policy has undergone review with only minor changes that relate to operational and / or clinical practice and was therefore circulated for a four week consultation to the following: Senior Management Team Local Negotiating Committee Consultant Psychiatrists Planned Care Group Specialist Care Group Urgent Care Group Psychological Services Clinical Governance and Medical Directorate Safeguarding Trust Allied Health Profession Services Finance, IM&T, Estates and Performance Staff-side Trust Pharmacy Workforce Communications 11 Equality and Diversity assessment 11.1 In conjunction with the Trust s Equality and Diversity Officer this policy has undergone an Equality and Diversity Impact Assessment which has taken into account all human rights in relation to disability, ethnicity, age and gender. The Trust undertakes to improve the working experience of staff and to ensure everyone is treated in a fair and consistent manner. 12 Implementation 12.1 Taking into consideration all the implications associated with this policy, it is considered that a target date 6 months from date of issue is achievable for the contents to be embedded within the organisation. 12.2 This will be monitored by the Quality and Performance Committee during the review process. If at any stage there is an indication that the target date cannot be met, then the Quality and Performance Committee will consider the implementation of an action plan. 13 Monitoring Compliance See Appendix C 13.1 The author will be responsible for carrying out a short monitoring task in order to monitor compliance of the clinical audit policy using the audit tool statements set out in Appendix C, Monitoring Tool. Should results find any non-compliance it may be necessary for the policy to undergo a full internal audit process. Northumberland, Tyne and Wear NHS Foundation Trust 15
14 Standards/Key Performance Indicators 14.1 The expectation for healthcare professionals to participate in regular clinical audit is well documented in the introduction of this policy. All clinical staff should be aware of the local and national standards required of the organisation when planning their clinical audit priorities. These should be informed by: 15 Fair Blame The Care Quality commission NHS core and developmental standards Darzi report High Quality Care for All (2008) Quality accounts N.I.C.E. technology appraisals and guidelines National Service Frameworks CQUIN Indicators Royal College guidelines Professional bodies 15.1 The Trust is committed to developing an open learning culture. It has endorsed the view that, wherever possible, disciplinary action will not be taken against members of staff who report near misses and adverse incidents, although there may be clearly defined occasions where disciplinary action will be taken. 16 Associated documentation NTW(O)01 - Development and Management of Procedural Documents Policy NTW(O)29 Confidentiality Policy NTW(O)36 Data Protection Policy NTW Clinical Effectiveness Strategy currently in development 17 References NICE (2002): Principles for best practice in clinical audit. National Institute for clinical excellence. Oxon. Radcliffe Medical Press. Darzi report: Department of Health (2008) High Quality Care for All: NHS Next Stage review final report London: DoH Data Protection Act 1998. (1998) London: Stationery Office Department of Health (1997) The Caldicott report. London. DOH QIP (2010) Template for policy and strategy. http://www.hqip.org.uk/templatepolicy-strategy Northumberland, Tyne and Wear NHS Foundation Trust 16
Appendix A Equality Analysis Screening Toolkit Names of Individuals involved in Review Date of Initial Screening Review Date Service Area / Directorate Chris Rowlands October 2014 October 2017 Policy to be analysed NTW(C)52 Clinical Audit Policy V03 Is this policy new or existing? Existing What are the intended outcomes of this work? Include outline of objectives and function aims It is the responsibility of all health care professionals to ensure that they are delivering the best possible quality of care to their patients and carers and that this care is evaluated regularly and robustly. Northumberland, Tyne and Wear NHS Foundation Trust (the Trust) are fully committed to delivering effective clinical audit as a means of developing and maintaining high quality and safe patient-centred services and this policy has been developed to ensure that the correct processes are followed by all staff who participates in clinical audit activities Who will be affected? e.g. staff, service users, carers, wider public etc This policy is applied without discrimination against any equality strand and does not discriminate Protected Characteristics under the Equality Act 2010. The following characteristics have protection under the Act and therefore require further analysis of the potential impact that the policy may have upon them Disability Sex Race Age Gender reassignment (including transgender) Sexual orientation. Religion or belief Marriage and Civil Partnership Pregnancy and maternity Carers Other identified groups N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Northumberland, Tyne and Wear NHS Foundation Trust 17
How have you engaged stakeholders in gathering evidence or testing the evidence available? Through standard policy process procedures How have you engaged stakeholders in testing the policy or programme proposals? Through standard policy process procedures For each engagement activity, please state who was involved, how and when they were engaged, and the key outputs: Appropriate policy review by author(s) Summary of Analysis Considering the evidence and engagement activity you listed above, please summarise the impact of your work. Consider whether the evidence shows potential for differential impact, if so state whether adverse or positive and for which groups. How you will mitigate any negative impacts. How you will include certain protected groups in services or expand their participation in public life. Now consider and detail below how the proposals impact on elimination of discrimination, harassment and victimisation, advance the equality of opportunity and promote good relations between groups. Where there is evidence, address each protected characteristic Eliminate discrimination, harassment and victimisation Advance equality of opportunity Promote good relations between groups What is the overall impact? No impact, no further evidence required Addressing the impact on equalities From the outcome of this Screening, have negative impacts been identified for any protected characteristics as defined by the Equality Act 2010? If yes, has a Full Impact Assessment been recommended? If not, why not? Manager s signature: Chris Rowlands Date: October 2014 Northumberland, Tyne and Wear NHS Foundation Trust 18
Appendix B Communication and Training Check list for policies Key Questions for the accountable committees designing, reviewing or agreeing a new Trust policy Is this a new policy with new training requirements or a change to an existing policy? If it is a change to an existing policy are there changes to the existing model of training delivery? If yes specify below. Are the awareness/training needs required to deliver the changes by law, national or local standards or best practice? Please give specific evidence that identifies the training need, e.g. National Guidance, CQC, NHSLA etc. Please identify the risks if training does not occur. Existing Policy All clinical staff who participate in clinical audit will be aware of and comply with the requirements of the clinical audit policy. Training is available through the practice development department, and individually via the clinical audit team Please specify which staff groups need to undertake this awareness/training. Please be specific. It may well be the case that certain groups will require different levels e.g. staff group A requires awareness and staff group B requires training. Is there a staff group that should be prioritised for this training / awareness? Please outline how the training will be delivered. Include who will deliver it and by what method. Training is available for all clinical staff with a target of 5% clinical staff to be trained in each group/directorate Nurse and service managers should have an awareness and compliance with the policy in order to protect patients and staff. Training sessions, clinical audit training pack, raising awareness through Clinical Audit ebulletin. The following may be useful to consider: Team brief/e bulletin of summary Management cascade Newsletter/leaflets/payslip attachment Focus groups for those concerned Local Induction Training Awareness sessions for those affected by the new policy Local demonstrations of techniques/equipment with reference documentation Staff Handbook Summary for easy reference Taught Session E Learning Please identify a link person who will liaise with the training department to arrange details for the Trust Training Prospectus, Administration needs etc. Senior Manager Research Innovation and Clinical Effectiveness Northumberland, Tyne and Wear NHS Foundation Trust 19
Statement Monitoring Tool Appendix C The Trust is working towards effective clinical governance and governance systems. To demonstrate effective care delivery and compliance, policy authors are required to include how monitoring of this policy is linked to auditable standards/key performance indicators will be undertaken using this framework. NTW(C)52 Clinical Audit Policy - Monitoring Framework Auditable Standard/Key Performance Indicators Frequency/Method/Person Responsible Where results and Any associate action plan will be reported to, implemented and monitored (this will usually be via the relevant Governance Group). 1. Audits are registered on the CA database through using the appropriate registration form which monitors progress Annual: percentage review of database (minimum of 10 clinical audits) Clinical Audit Department Appropriate committee (Q&P/CEC/Group Q&P) 2. 3. 4. 5. 6. Audits have associated report and action plans returned within 12 months Audit reports follow set format (Appendix 4) All action plans are reported, actioned and improved outcomes reported at appropriate responsible committee All required re-audits are forwarded to next year s plan All Audits in the Trust should be registered and approved in accordance with this policy 7. The Trust has an annual audit plan incorporating local and national requirements Annual: percentage review of database (minimum of 10 clinical audits Clinical Audit Department Annual: percentage review of database (minimum of 10 clinical audits Clinical Audit Department Annual: percentage review of database (minimum of 10 clinical audits) Clinical Audit Department Annual: percentage review of database (minimum of 10 clinical audits) Clinical Audit Department Annual: percentage review of database (minimum of 10 clinical audits Clinical Audit Department Approved at Q&P and progress reported monthly Clinical Audit Department Appropriate committee (Q&P/CEC/Group Q&P) Appropriate committee (Q&P/CEC/Group Q&P) Appropriate committee (Q&P/CEC/Group Q&P) Appropriate committee (Q&P/CEC/Group Q&P) Appropriate committee (Q&P/CEC/Group Q&P) Appropriate committee (Q&P/CEC/Group Q&P) The Author(s) of each policy is required to complete this monitoring template and ensure that the results are taken to the appropriate Quality and Performance Governance Group in line with the frequency set out. Northumberland, Tyne and Wear NHS Foundation Trust 20