A University Teaching Trust
Quality Improvement - Clinical Audit Policy
Version Number:
6.0
Name of Originator/Author:
Head of Regulation, Compliance and Quality Improvement
Name of Responsible Committee:
Quality Board
Name of Executive Lead:
The Chief Nurse and Director of Quality Assurance
Date V1 issued:
Not recorded – V3 shows December 2009
Last Reviewed:
March 2013
Next Review date:
January 2016
Scope:
Trust wide
MMHSCT Document Code:
CO-02
Where People Matter Most
A University Teaching Trust
Document Control Sheet Type of Procedural Policy Specific Category / Corporate Document Directorate Document Purpose This document offers the Trust approach to clinical audit. This includes the development, completion and dissemination of audits completed within the Trust. Setting standards for delivery and operational management of clinical audit as a quality improvement tool. Consultation Quality Board, the Integrated Risk Management & Clinical Governance Committee, Local Audit Groups, Patient Experience Committee, Operational Management Team. Medical Staffing Committee - 3 Weeks. Approving Committee Quality Board Approval Date 12 February 2013 Ratification and Date Trust Management Board Date of Ratification: 26 February 2013 Procedural Documents to be read in conjunction with Quality Improvement Strategy this document: Training Needs Analysis Impact
There are Training requirements for Financial There are Financial resource impacts. this procedural document. Resource The Learning and Development team Impact Currently the budget for the department are will be approached for advice on the a band 4 and band 6 administrative posts. training requirements for this policy. To fully deliver the standards within this Current impact is focused upon the policy a review of the financial support Junior Doctor induction with bespoke available may be necessary. Quality Board training being provided by the Quality to consider at point of review and Improvement Team. recommendations to be made and Standard e-learning packages are completed by Head of Patient Experience available to staff through the intranet and The Chief Nurse and Director of but this may not prove adequate in the Quality Assurance. longer term to promote and facilitate delivery of this policy across all services. Document Change History Changes to this document in different versions must be detailed below. Rationale for the change should also be given Version Type of Date Details of Change and approving group or Executive Lead (if Number / Change i.e. done outside of the formal revision process) Name of Review / procedural Legislation / document this Claim / supersedes Complaint V4 Trust Wide Review January 2013 Significant changes made to the previous policy to Policy for incorporate national standards and guidance. Service Audit V5.0 Review March 2013 Minor Change as a result of NHSLA assessment – added requirement for approving group to appear on Clinical Audit Programme and minimum criteria for CAP. Page 17, section 6.1 and page 19, Section 8.1 Executive Approval from The Chief Nurse and Director of th Quality Assurance – 27 March 2013 via email. V6.0 Review April 2015 Sections 5.8 and 8.2 have been removed as they reference the function of the Quality Improvement Group which no longer takes place as audit is reported through IRM&CGC. Following recommendations from MIAA the report template and registration form are included as appendix 3 & 4 to ensure consistency in audit documentation and reporting. Sections 6.3 – 6.6 have been added following recommendation from MIAA to show how audit priorities are triangulated and to also display the Trust priority matrix for audit selection. Responsible staff titles have also been updated: Head of RCQI has been replaced with Head of Patient Experience and the Director of Nursing & Therapies Page 2 of 42
has been replaced by the Chief Nurse and Director of Quality Assurance. The Clinical Governance Committee and Risk Committee group names have both been replaced by the Integrated Risk and Clinical Governance Committee in the updated policy document. Please ensure that any external references used in the creation of this document are entered as the final section of this procedural document. External References have been included in the body of the Procedural Document Privacy Impact Assessment submitted?
Please ensure this is completed this at each consultation stage:
YES
Any issues?
x
NO
N/A
No
N/A Date: N/A Please ensure this is completed this Fraud Proofing Any issues? No at each consultation stage: submitted? N/A Date: N/A Policy authors are asked to consider each of the nine protected characteristics under the Equality Act 2010. We expect you to demonstrate that throughout the policy process you have had regard to the aims of the Equality Duty: 1. Eliminate unlawful discrimination, harassment and victimisation and any other conduct prohibited by the Act; 2. Advance equality of opportunity between people who share a protected characteristic and people who do not share it; and 3. Foster good relations between people who share a protected characteristic and people who do not share it. Please provide a brief account of how you have done this, further work to be completed and any support you have had in considering the aims and working in compliance with the Equality Duty. If you are unclear on how to do this or would like further advice and support then you may contact
[email protected]. It is the responsibility of the approving Committee/group/meetings to ensure this statement reflects the Trusts objectives and position with compliance as set out within the NHS Equality Delivery System Please confirm that the statement below is correct. If not please indicate why?
YES
This procedural document is broad and the scope is Trustwide so complies with the Trust‟s Equality Delivery Service Quality Improvement through clinical audit is designed to be inclusive to all and not discriminate against any of the nine protected characteristics. Areas included in this policy relating to the patient and public involvement in our clinical audit processes will have a positive impact on our approaches to the Equality Act and our duties. The Trust also aims to ensure that its healthcare and facilities are not discriminatory and, wherever possible, attend to the physical, psychological, spiritual, and social and communication needs of any patient or visitor showing no discrimination on the grounds of ethnic origin or nationality, disability, gender, gender reassignment, marital status, age, sexual orientation, race, trade union activity or political or religious beliefs. The process for determining choice of clinical audit projects, and the manner in which project patient samples are drawn up, should not inadvertently discriminate against any groups in society based on their race, disability, gender, age, sexual orientation, religion and belief. Any person who has concerns regarding the ethics of clinical audit activity within the Trust should refer them in the first instance to the Integrated Risk & Clinical Governance Committee, who may require equality impact assessments to be undertaken and / or equality data to be collected as part of clinical audits in order to determine whether any particular groups of patients are experiencing variations in practice. In line with the Trust values can this Procedural Document be YES X NO published on the Trust‟s External Website. It is the Authors responsibility to ensure all procedural documents comply with the Trust values If you are unclear on any of the requirements in the document control sheet then please email
[email protected] before proceeding
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Monitoring and Compliance Requirements Sheet (This section MUST be completed by the Author without exception). This section demonstrates the Trust’s commitment to Continuous Improvement and Lessons Learned from Incidents, Reports from the Coroner or other External Agencies and will be submitted as evidence as required. Minimum Requirement/Standard/Indicator to be monitored and Section of Document it appears
1
2
3
4
5
6
7
8
Level 1/a Duties Page 12, Section 5 Level 1/b How the organisation sets priorities for audit including local and national requirements Page 17, Section 6 Level 1/c requirement that audits are conducted in line with the approved process for audit Page 22, Section 9 Level 1/d how audit reports are shared page 22, Section 10 Level 1/e format for all audit reports, including methodology, conclusions, action plans, etc. Page 23, Section 11 Level 1/f How the organisation makes improvements Page 24, Section 13 Level 1/g how the organisation monitors action plans and carries out re-audits Page 23, Section 12 Level 1/h how the organisation monitors compliance with all of the above.
Process for monitoring
Review of Policy Document
Report by Lead
Responsible Individual
Frequency of Monitoring
Responsible Committee/Group/meeting for review of results / action plan approval / implementation
3 Yearly
Quality Board
As all requirements and standards are related to the content of this policy the existence of the policy offers evidence of compliance
3 Yearly
Quality Board
As all requirements and standards are related to the content of this policy
Head of Patient Experience Quality Board
Head of Patient Experience Quality Board
Comments
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Page 27, Section 16
9
10
11
12
13
14
15
16
Level 2/a How we implement the requirement that audits are conducted in line with the approved process for audit Page 28, Section 19 Level 2/b How we implement the documented process for how the organisation makes improvements. Page 24, Section 13 Level 3/a How we monitor requirement that audits are conducted in line with the approved process for audit Page 27, Section 16 Level 3/b How we monitor the requirement of the documented process for how the organisation makes improvements. Page 24, Section 13 Level 3/c Where our monitoring has identified shortfalls, we must evidence that changes have been made to address them. Page 24, Section 13 Level 1/c – Standard 2.6 How the information from audit informs the risk registers and risk profile for the Trust Page 20, section 8 Level 1/g – Standard 2.6 Minimum timescales for sharing information Page 26, Section 10 Level 1-3 – Standard 2.7 Ensuring that information gained from clinical negligence claims is included in the annual audit plans and also re-audit cycles Page 16, Section 6
the existence of the policy offers evidence of compliance Report by Lead
Report by Lead
Report by Lead
Report by Lead
Report by Lead
Report by Lead
Report by Lead
Report by Lead
Head of Patient Experience Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Annual Audit Report
Yearly
Quality Board
Yearly
Quality Board
Quality Board Head of Patient Experience Quality Board Head of Patient Experience Quality Board
Head of Patient Experience Quality Board
Head of Patient Experience Quality Board Head of Patient Experience Quality Board Head of Patient Experience
Annual Audit Report
Quality Board Head of Patient Experience Annual Audit Report
Quality Board Page 5 of 42
NB: If you have selected audit you should complete the required audit registration form and standards document and submit these with your expected timescales for completing the audit to
[email protected] as soon as possible and no later than 4 weeks prior to the audit commencing. Please see appendix 3 and 4 for the Trust audit project registration form and the standard report template with the action plan format included. The Group / Committee should also ensure the monitoring work is added to their yearly schedule of monitoring and action logs as appropriate.
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Table of Contents
Section
Description
Page Number
1
Executive Summary
9
2
Aims and Objectives
9
3
Definitions
10
3.1
Clinical Audit
10
3.2
National Audit
10
3.3
Research
11
3.4
Service Evaluation or Review
11
4
Scope
11
5
Duties
11
5.1
Chief Executive
11
5.2
The Chief Nurse and Director of Quality Assurance
12
5.3
Medical Director
12
5.4
Executive Team
12
5.5
Quality Board
12
5.6
Head of Patient Experience
12
6
5.7 The Integrated Risk Management &Clinical Governance Committee
13
5.8
Operational Management Team and Care Groups
13
5.9
Clinical Leads
13
5.10 Quality Improvement Department
14
5.11 Sponsor
14
5.12 Auditor(s)
15
5.13 Standard Lead
15
Clinical Audit Programme
15
6.1
Development
15
6.2
Priority Settings
16
6.3
Development of the Clinical Audit Programme
16
6.4
Selection of Audits
17
6.5
Externally Required Audits
17
6.6
Internally Identified Audits
17 Page 7 of 42
6.7
National Audits
18
6.8 Serious Untoward Incidents, Complaints and Clinical Negligence Claims
19
7
Standards
19
8
Reporting Structure
20
8.1
20
Local Audit Meeting or Group/Committee
8.2 The Integrated Risk Management &Clinical Governance Committee
20
8.3
Quality Board
20
8.4
Trust Board
20
9
Audit Systems and Registration
21
10
Process for Disseminating Audit Result
21
11
Format for all Audit Reports
22
12
Process for Monitoring Action Plans and Re-Audits
22
13
Process for Making and Sustaining Improvements
23
14
Involvement of Service Users and Carers
23
14.1 Audit Selection
24
14.2 Workshops
24
14.3 Presentations
24
14.4 Data Collections
24
15
Medical Students and F1/F2 Doctors
25
16
Monitoring and Annual Reports
26
17
Ethics and Consent
26
18
Information Governance: Collection, storage and retention of data and confidentiality
27
18.1 Confidentiality Agreements
27
Implementation of this Policy
27
Appx 1
Initial Scan for Privacy Impact Assessment requirement
28
Appx 2
Privacy Impact Assessment Procedure
30
Appx 3
Quality Improvement Audit Project Registration Form
33
Appx 4
Quality Improvement Trust Report Template for Audit
37
19 Appendix
We strongly recommend the use of flowcharts as a simplified step for staff to follow in the implementation of this Procedural Document Page 8 of 42
Quality Improvement - Clinical Audit Policy 1
Executive Summary
1.1
Clinical audit offers quality improvement and assurance processes for the Trust. It ensures compliance with clinical standard‟s, identifies and minimises risks and improves outcomes for our service users when used effectively. The Trust attaches significant importance to the role of clinical audit and its participation in both local auditing processes and those completed as part of its statutory and contractual responsibilities.
1.2
The delivery of a successful clinical audit programme is integral to our commissioning contracts and includes the participation in national audits relevant to our services. The Care Quality Commission registration also requires the Trust to regularly assess and monitor the quality of our services using the findings from audits and reviews we complete.
1.3
This policy aims to standardise the approach to clinical audit across the Trust and offer assurance to the Trust Board that we are undertaking audit in line with regulatory and national guidance. It also seeks to make clinical audit open to all our staff and service users to improve the quality improvement culture and support development and accountability for the Trust Assurance Framework.
1.4
Audit is also a key NHSLA standard with minimum requirements of the Trust approach and documented processes to Clinical Audit. As such it is a requirement for clinical audits to be conducted in line with this policy and results to be widely shared across relevant service areas. This will help the Trust improve its patient safety techniques and increase our ability to learn lessons from each other.
2
Aims and Objectives
2.1
This policy sets the strategic framework for the conduct of clinical audit within the Trust. By providing standards and guidance the Trust expects to be clear in its procedures and expectations for all those impacted by the Clinical Audit Programme.
2.2
The policy establishes the registration and approval processes for clinical audit project proposals. This includes the next steps for staff in developing and designing clinical audit projects.
2.3
The Trust wants to ensure the maintenance of a best practice culture in relation to Quality Improvement overall and specifically the management and delivery of clinical audit across professions and services.
2.4
This policy also seeks to underpin the Quality Improvement Strategy for the Trust through the clinical audit processes and by offering an important quality improvement tool. The Trust believes we should all operate as our own regulators and this policy aims to support the corporate requirements while enabling and improving clinicians‟ abilities to monitor and audit their own delivery of care.
2.5
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2.6
This policy also sets out the minimum expectations in regards to record keeping and action planning related to clinical audit. This has been developed to support and demonstrate compliance with the Trust and individual practitioners‟ compliance with regulatory and other requirements placed upon them.
2.7
All clinical audit activity undertaken in the Trust must comply with the requirements of this policy.
2.8
The key aims and objectives of this policy are: 2.8.1 2.8.2 2.8.3 2.8.4 2.8.5
That clinical audit meets the national and local commitments and expectations Prioritises local concerns using information from all areas of the organisation and through engagement with stakeholders Integrates clinical audit with internal audit to ensure a consistent approach to quality assurance and internal compliance monitoring Delivers a return on the financial and professional resources for audit Ensures improvements are implemented and sustained to improve the patient experience and reduce risk
3
Definitions
3.1
Clinical Audit Clinical audit is a quality improvement cycle that involves measurement of the effectiveness of healthcare against agreed and proven standards for high quality, and taking action to bring practice in line with these standards so as to improve the quality of care and health outcomes. (HQIP „New Principles for Best Practice in Clinical Audit‟. Radcliffe Publishing, 2011).
3.2
National Audit A national clinical audit is either a project funded by HQIP (those in the NCAPOP programme, plus the NJR and PicaNet) or, although separately funded, a project which meets all of the following criteria:
3.2.1
national coverage (achieved or intended) main focus is improving the quality of clinical practice evaluates practice against clinical criteria/guidelines and/or collects outcomes data applies the complete audit cycle and/or monitors clinical/patient outcomes data in an ongoing way as part of a programme of driving change is prospective - i.e. does not include retrospective reviews of adverse outcomes such as confidential enquiries includes patients in their governance and takes data from patients themselves.
Confidential enquiries such as the CORP programme funded by HQIP are therefore not in themselves audits, although they have strongly audit like features. Similarly national surveys of patient's experiences and self-reported outcomes are not strictly audits although again they are closely related.
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3.2.2
National clinical audit is designed to improve patient outcomes across a wide range of medical, surgical and mental health conditions. Its purpose is to engage all healthcare professionals across England and Wales in systematic evaluation of their clinical practice against standards and to support and encourage improvement in the quality of treatment and care.
3.3
Research Research is completed with the aim of deriving new knowledge and is usually initiated by researchers. This will usually address clearly defined questions and hypotheses using systematic processes. Research is led by the Research and Development Team and not the Quality Improvement Team.
3.4
Service Evaluation or Review Evaluations and reviews are judgements of a services efficiency or effectiveness. They are usually completed by service managers or local teams. Other terms may be used including benchmarking, non-clinical audit or service review. While the Quality Improvement department may record an evaluation or review these are not included in the clinical audit programme and will generally led by other departments with little input from the Quality Improvement team.
4
Scope
4.1
This policy applies to anyone engaged in the clinical audit process on behalf of the Trust. This will include but is not limited to;
All staff, clinical and non-clinical including those on short term or agency contracts with the Trust
Students and trainees in any discipline
Patients, carers, volunteers and members of the public taking part in audit
4.2
This policy will also apply when clinical audit is undertaken jointly across organisational boundaries and involving Trust services or patients.
4.3
The Trust encourages clinical audit to be undertaken jointly across professions and organisational boundaries. This includes partnership working with local and regional organisations and will be encouraged with the full support of the Trust Board to seek improvements to outcomes and the patient journey.
4.4
The Trust supports the collaborative working between multi-professions in clinical audits that are of interest to other parts of the local health economy, both within and outside the NHS.
5
Duties
5.1
Chief Executive The Chief Executives retains overall responsibility for the quality improvement, governance and risk management of the Trust business.
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5.2
The Chief Nurse and Director of Quality Assurance The Chief Nurse and Director of Quality Assurance provides Executive Leadership on the delivery of Clinical Audit as part of their remit for assurance, governance and compliance.
5.3
Medical Director The Medical Director is responsible for the medical support of clinical audit. This includes the training and delivery of audit for doctors employed in the Trust. This also includes the identification of clinical leads.
5.4
Executive Team The Executive Team will take a responsibility for individual audit leads and national audits. This may include the implementation of quality improvements as a result and ensuring issues are escalated and managed within the Board Assurance Framework. The Executive teams offer leadership and direction for audit within the Trust and should seek to ensure key managers and committees they are responsible for adhere to this policy and promote involvement in audit. The Executive team also has a responsibility for driving quality assurance, compliance and learning lessons through the use of both clinical audit and internal audit. They will use clinical audit as a key tool in the strategic management approaches and work to ensure the clinical audit and internal audit programmes are allied to broader interests and targets that the Trust Board are addressing.
5.5
Quality Board The Quality Board has responsibility for ensuring the production, review and implementation of this policy is completed. The Quality Board has a key responsibility to ensure the Board‟s duty to drive quality assurance, measure compliance and ensure we „close the loop‟ on improvements identified through clinical audits. The Quality Board will discharge their duties through regular reports from the Integrated Risk Management & Clinical Governance Committee.
5.6
Head of Patient Experience The Head of Patient Experience will lead on the delivery of clinical audit, systems and processes to support clinical audit and the approach to quality improvement for audit overall. This will include the management of staff working within the Quality Improvement team, the development of the Clinical Audit report and the monitoring reports throughout the year. Additionally the Head of Head of Patient Experience is;
To ensure that the Trust clinical audit strategy and annual programme of work are allied to the Board‟s strategic interests and concerns
To ensure that clinical audit is used appropriately to support the Board Assurance Framework Page 12 of 42
To ensure this policy is implemented across all relevant areas
To establish and promote joint working between the Trust‟s audit function and the internal audit within the Trust wherever possible
To ensure that any serious concerns regarding the Trust‟s policy and practice in clinical audit, or regarding the results and outcomes of clinical audits, are brought to the attention of the Board using the Trust Board Assurance and Escalation Framework
5.7
The Integrated Risk Management & Clinical Governance Committee The Integrated Risk Management & Clinical Governance Committee will advise the Quality Board on areas of concern or action relating to the management of clinical audit and progress against the Clinical Audit Programme.
5.8
Operational Management Team and Care Groups The Operational Management Team and the Care Group leads are responsible for ensuring that service development and delivery is underpinned by clinical audit. This includes monitoring, implementation and shared learning through the clinical audit delivery. They are responsible for delivery of their areas of the Clinical Audit Programme and escalation of any issues with this.
5.9
Clinical Leads All Clinical Directors must ensure that a senior clinician within their directorate is nominated as the Directorate Lead for Clinical Audit (they may choose to take on this role themselves). The responsibilities of the Directorate Leads for Clinical Audit are:
To ensure that this policy is implemented throughout their directorate.
To ensure that all clinical audit activity within their directorate is registered and complies with nationally accepted best practice standards
To ensure that their Directorate participates in all national clinical audits, national confidential enquiries and inquiries and service reviews which are relevant to the services which it provides
To work with clinicians, service managers, Divisional Governance and Quality Managers and clinical audit staff to ensure that the clinical audit programme for their directorate meets all clinical, statutory, regulatory, commissioning and other Trust requirements.
All staff employed by the Trust have a responsibility for the quality of the service which they provide, and all clinically qualified staff are individually accountable for ensuring they audit their own practice in accordance with their professional codes of conduct and in line with the standards set out within this document
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5.10
Quality Improvement Department The Quality Improvement Department will support the Head of Patient Experience in:
5.11
Developing the Clinical Audit Programme (CAP) Working with other departments to ensure the CAP is consistent with the strategic and governance aims of the Trust Maintain a database of all registered audits Provide support to Sponsors and auditors with literature, registration processes, appropriate audit tools and methodology Liaise with clinical staff and managers to identify requirements for each audit on the CAP Offer guidance where audits are being undertaken or identified outside the CAP Devise suitable methodology with staff delivering audits Undertake and coordinate data collection from electronic systems Produce reports and analysis where identified necessary Organise and maintain manual and electronic records, ensuring confidentiality is maintained at all times Work with staff in the design and implementation of audit projects Work with managers to ensure the results of clinical audit are disseminated and followed up Collate information for reports to the relevant committees and groups To provide the data and initial annual audit report including the provision of information in the Quality Account Ensuring cohesion with the commissioning requirements and the Audit approach within the Trust To support local audit meetings and work with clinical leads To maintain and develop the Trust Intranet and Internet sites To promote and support the involvement of service users and carers in audit To participate in, develop and deliver clinical audit training in the Trust Produce up to date guidance and procedures for audit within the Trust Ensure that sponsors and auditors are supported in delivering their audits to meet deadlines and reminded of the submission times wherever necessary Advising staff on the involvement of stakeholders
Sponsor The Trust uses the term sponsor to identify the lead member of staff for each audit. The sponsor will be a senior (Band 7 and above) member of staff who assesses the relevance and appropriateness of the audit for the member of staff completing this i.e. personal development, training needs and also for the service where the audit is being completed. The sponsor will also be expected to identify another member of staff if the auditor(s) leave their post prior to completion.
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The sponsor will be the second point of contact for the Quality Improvement team when queries or concerns relating to the delivery of the audit arise. Sponsors should scrutinise the registration form and agree with the declaration prior to any data collection commencing. 5.12
Auditor(s) The auditor will be the member of staff identified to complete the audit according to this document and agreed timescales. They will liaise with the managers or clinical supervisors and the Quality Improvement Team to request support, information, training and resources as required. Auditors must ensure all stages of the audit process are completed including the production of standard forms and feedback of results and learning from the audit. The auditor will be expected to ensure completion dates are communicated and adhered to where other members of staff are involved in the audit.
5.13
Standards Lead On the Clinical Audit Programme there will be Standard Leads identified against each audit topic. The leads are identified through their corporate responsibility for the area specified. While they are not expected to complete the audits themselves, and it will not always be their team completing the audit, they are expected to offer expert advice to anyone completing an audit in their relevant area. This may be limited to having an awareness of the audit taking place or may require them to become more involved at different stages of the audit. By having a standard lead available to the auditor/sponsor and the Quality Improvement Team it ensures specialist advice is available and also allows opportunity for building the results and actions in to pre-existing work streams or sharing learning.
6
Clinical Audit Programme
6.1
Development The Clinical Audit Programme will be developed in February and March each year. This will be shared with the Trust Committees and Operational Management Team prior to submission to the Quality Board for approval. The consultation period will be no less than 2 weeks. The CAP will provide an outline of the key audit activity for the coming financial year. While the plan is established through known priority topics the programme is not considered fixed by the Trust and will be updated, amended and added to throughout the course of the year.
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The CAP will also include as a minimum; - Standards Lead - Title of Proposed Audit - Executive Lead (if national audit) - Rationale for selection - Approving Group - Predicted timescale for audit 6.2
Priority Setting To ensure the CAP is material the Quality Improvement Team will use a range of governance information to develop the priorities within the CAP. This will include the Corporate Risk Register and the strategic aims of the Trust. National priorities will be considered along with local Trust priorities. Commissioners and other relevant stakeholder will also be asked to consult on the Clinical Audit Programme. Re-audits will be included in the Clinical Audit Programme where actions have been identified to be re-audited. Re-auditing is a fundamental element of the audit process and the Trust will endeavour to allocate at least 30% of its clinical audit programme to re-audits. Patient safety incidents will form a core part of the priority setting to look at quality improvement initiatives that can prevent the reoccurrence of incidents. Only the Quality Board can approve the Clinical Audit Programme.
6.3
Development of the Clinical Audit Programme The CAP is developed in line with the Trust‟s statutory and mandatory requirements. The identification of audits is aligned to the Trust‟s risk register and strategic objectives. Contractual obligations to Commissioners have been included in the audits. This is through participation in the National Clinical Audit Patients Outcome Programme (NCAPOP) relevant to our service, the Quality Requirements of Trust contracts and the Commissioning for Quality and Innovation (CQUIN) Framework. Regulatory requirements are also central to the development of our CAP and the framework operated by the Care Quality Commission (CQC) drives the Trust selection of audit topics. This framework requires the Trust to regularly assess and monitor the quality of the services provided to the public and ensure the Trust embed the findings through Clinical Audit in any action plans for the year. The NHS Litigation Authority (NHSLA) Risk Management Standards and the Trust‟s plans for future assessments are included in the development of our CAP. In 2013/14 NHSLA stopped assessing Manchester Mental Health and Social Care Trust, to ensure the highest standards are adhered to the Trust continues to use NHSLA Risk Management Standards.
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Stakeholders views are an important part of the development of the CAP and consultation on the audits selected will form an integral part of the Trust‟s delivery of Clinical Audit. To develop the CAP the Quality Team seeks information through the existing monitoring and reporting frameworks available to the Trust to develop the CAP which includes;
Patient Experience Committee reports, Service User & Carer Forum reports, Complaints Reports, SUI and Rule 43 Reports and; Staff Survey results Patient survey results
6.4
Selection of Audits The development of the CAP as outlined above requires the Trust to determine priority audits for the year. The Trust has seeks to address both the national and local priorities and ensure a high value and cost effective programme. Currently the Trust focuses on the areas that are fundamentally important to corporate objectives, risks and offer assurance to the Trust Board and stakeholders.
6.5
Externally Required Audits All NHS Trusts have to complete clinical audit projects as a result of external requirements such as CQC Registration, NCAPOP, NICE Guidance, National Service Frameworks, Clinical Outcomes Review Programme and those identified through Commissioner contracts. The Trust welcomes the opportunity to complete these audits as they provide invaluable benchmarking opportunities and the benefits to service users of national support, information and improvement.
6.6
Internally Identified Audits Throughout the monitoring and reporting work completed by the Trust each year audits are identified that are a high priority for the Trust. These are based on criteria of high risk or high profile and we cross reference these topics with our risk registers and quality data. Audits in the Trust CAP look to current service pressures incorporate recommendations from complaints and serious untoward incidents and a range of other sources available to the Trust including from data that is presented at the Trust‟s Quality Board. In doing so it is ensured that the Trust acts as its own first line regulator although assessments are included completed by external bodies such as the Mental Health Act visits and Quality and Risk Profiles provided by the Care Quality Commission. Internal audits have also been selected which offer the most realistic and achievable patient outcomes and opportunities for improvement.
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The audit priority matrix is detailed in table 1 below Table 1 – Priority Matrix Priority Level Matrix 1
External „Must-do‟ – National Audits, Clinical Outcomes Review Programme, CQUIN‟s
2
Internal „Must-do‟ - Corporate Risk Register, Serious Incidents Requiring Investigation, NHSLA, Complaints, Rule 43, Clinical Strategy, External agency recommendations
3
High local priority – Care Division or clinical local need identified, local risk registers, local incident reports, high volume, cost or risk, evidence of adverse outcomes, new business proposal/service plan
4
Medium local priority - Care Division or clinical local need identified, local risk registers, local incident reports, medium volume, cost or risk, expect adverse outcomes
5
Low local priority - Care Division or clinical local need identified, local risk registers, local incident reports, low volume, cost or risk, expect adverse outcomes
Quality Improvement Priorities The Quality Improvement Strategy 2013-2016 sets out three core priorities for the Trust. Audit themes have been identified against the priorities to promote transparency in our selection and links to wider projects. The three priorities are detailed below in figure 1. Figure 1 – Trust Core Priorities
1. More people will recover from mental health problems and feel supported in achieving a good quality of life
2. People will feel safe when accessing our services with fewer people suffering avoidable harm
3. People have a positive experience of their care and support
6.7 National Audits The Trust will endeavour to participate in all national audit projects that are relevant to the organisation and publish the outcomes in the Quality Account. The Quality Improvement team will be responsible for the identification of the National Audits and advise Executive Leads on the commencement of any relevant audits. Page 18 of 42
6.8 Serious Untoward Incidents, Complaints and Clinical Negligence Claims The Governance Team will work closely to ensure that audits are added to the CAP that incorporate learning from the previous year‟s SUI‟s, Complaints and claims. However in recognition that throughout the year there will be SUI‟s, complaints and claims that require immediate action through audit the agreed process will be: -
The lead investigator or chair of the SUI Panel will make a recommendation for audit in the action plan This report will be sent to the Quality Improvement Team by the lead department to be reviewed against current priorities and scheduled for completion on the CAP
This process will ensure that audits are conducted and aligned with strategic priorities. Actions plans should not determine audit timescales without the involvement of the Quality Improvement Team.
7
Standards The audit programme is reliant upon the identification of appropriate standards. All audit projects must be approved by the Quality Improvement team who will ensure standards have been identified and seek to link work wherever possible to ensure the Trust is running and efficient and effective audit programme. Standards will be established from a range of literature and publications. The following organisations are most commonly used when developing audit projects; • National Institute for Health and Clinical Excellence (NICE) • National Patient Safety Agency (NPSA) • National Service Framework Standards (NSF) • Nursing and Midwifery Council (NMC) • General Medical Council (GMC) • Care Quality Commission (CQC) • Department of Health (DH) • Royal College of Nursing (RCN) • NHS Evidence • National Clinical Audit Advisory Group (NCAAG) • Healthcare Quality Improvement Partnership (HQIP) • National Health Service Litigation Authority (NHSLA) • Health Professionals Council (HPC) • General Social Care Council (GSCC) The Trust‟s policy on procedural documents also identifies monitoring and compliance requirements on its policies. This will also be used in the development of audit projects and procedural document authors may be contacted for their involvement and guidance.
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The Quality Improvement Team will work with the sponsor and auditor to research the topic area and source best practice. The Quality Improvement Team will give advice and assistance with the development of the audit tool to reflect the chosen standards. The standard registration form must always be used to capture the standards. On the CAP the term „Standard Lead‟ will also be identified for the audit topics. This will allow the expert lead or team for the Trust to be linked to audit topics and offer specialist advice to those completing audits. An example of this would be the audits related to standards for the Mental Health Act would have the Mental Health Law Team as the lead. While it will not necessarily be the standards leads who will complete all audits related to that standard, it is expected that they will advise on the standards and seek to inform associated action plans with other work relating to that area.
8 Reporting Structure Sponsors and auditors are encouraged to submit their audit proposals to relevant groups or committees prior to commencing data collection to ensure they have captured all information and encourage a wide team approach. Once an audit has been completed and the report and recommendations are available the following reporting structure must be adhered to; 8.1 Local Audit Meeting or Group / Committee Sponsor, auditor, delegate or Quality Improvement Team will present the recommendations to the approving group and discuss the findings. The audit report will then be approved along with the action plan. The final report (with any changes or updates from the meeting) will be sent to the Quality Improvement Team by the sponsor or auditor within a maximum of 4 weeks of the meeting. This will include the developed action plan as approved by the group. 8.2 The Integrated Risk Management & Clinical Governance Committee The Integrated Risk Management & Clinical Governance Committee will receive Executive Summaries, presented by the Head of Patient Experience, of each audit completed on the CAP. 8.3 Quality Board The Quality Board will receive exception reports where audits on the CAP have been completed and No or Limited Assurance is found. 8.4 Trust Board The Trust will receive information relating to audit through the Trust Board Assurance and Escalation Framework where necessary. They will also receive the Quality Account and annual Audit Report on a yearly basis which will summarise all audits undertaken.
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Where, during audit activity, a lead identifies practice that is deemed unsafe or that would potentially put the service user or staff at risk, it is the responsibility of the audit lead to ensure that this is reflected on the appropriate risk register.
9 Audit Systems and Registration The requirements are that all audits are conducted in line with the approved process for audit. This means all audits must be registered for approval with the Trust registration form. Once a project is approved a confirmation email and project number will be sent to the sponsor and the auditor(s) by the Quality Improvement Team. All audits, irrespective of support or facilitation required by the Quality Improvement Team, must be registered and confirmation of approval received by the sponsor and author. Please see a copy of Trust the registration document in appendix 3. The systems, forms and details will be established in Standard Operating Procedures that are approved by the Integrated Risk Management & Clinical Governance Committee. Data provided on registration will be used to compile a database of all clinical audit activity undertaken throughout the Trust. This database will be updated regularly by the Quality Improvement Team and will be used to report to Quality Board on the progress of the annual clinical audit programme. The format and content of the databases will be subject to review and approval by the Head of Patient Experience. As a minimum the approved process for audit is: -
Audit registration form completed Project number assigned Data collection completed Audit report and analysis completed Presentation of report and findings to approving group Action plan completed and assurance level agreed by approving group Re-audit completed if deemed necessary
10 Process for Disseminating Audit Results The findings of completed audits will be written up in the Trust standard audit report format by the auditor, please see a copy of the Trust report template in appendix 4. The Quality Improvement team will offer support with analysing the data and finalising the report. The final report must then be shared with at least one group or committee in the Trust Assurance Framework and all recommendations or action plans approved by that group or committee.
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The Quality Improvement Team will advise the sponsor and auditor on other relevant groups or teams who may benefit from sight of the report and findings. All audit reports will be uploaded onto a central electronic location, unless issues have been identified with sharing by the sponsor, to allow widespread availability of audit results and findings. Where assurance and risk is found to necessitate a re-audit the auditor and sponsor should offer a suggested re-audit time scale to the Quality Improvement Team. This will then be considered when setting the Clinical Audit Programme. Re-audit is an important stage in the audit cycle and determines whether agreed actions have been implemented according to the action plan. Difficulty arises where limited resource is available to teams and services in completing audits and priorities may have changed since the time of the original audit. The Trust aims to allow at least 30% of its annual audit programme to be dedicated to re-auditing and this applies through to the individual teams. Concerns or issues with this approach should be raised with the Quality Improvement Team for further discussion.
11 Format for all Audit Reports The Trust standard report will include as a minimum; -
Executive Summary Assurance Level Background Aims and Objectives Standards Action taken on previous results (if applicable) Methodology Findings/Results Recommendations Outcomes and Benefits Action Plan
Please see a copy of the Trust report template in appendix 4.
12 Process for Monitoring Action Plans and Re-Audits Each approving group or committee is responsible for the monitoring of action plans resulting from audit. All action plans must be on the Trust standard format.
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Re-audits are identified as at least a 30% of our annual clinical audit programme to ensure the full cycle of audit is completed. The Quality Improvement team will work with local groups and services to identify and agree their re-audit plans for the coming year.
13 Process for Making and Sustaining Improvements The process for making improvements will be monitored through audit action plans. Not all clinical audits will require an action plan, i.e. where an audit shows that standards are being met or guidelines followed. For such audits there should be an explicit statement saying „no further action required‟ in the audit summary. Audit reports will detail action taken on previous audit results where this is applicable. All actions must be agreed by an approving group. This avoids actions that are not relevant to the Trust strategic aims or risk management approaches. Often audits may identify possible actions that may require significant investment from the Trust to improve this process. For this reason all action plans must have a lead manager at Band 7 or above who will be able to consider the risks of taking or not taking the action identified and agree work plans with the involvement of Finance and other relevant departments. The lead manager will be identified by the approving group or Committee. While the process for our selection of audits should address the requirement that the audit topic is relevant to the Trust this also needs to be applied to recommendations and actions for change following the audit. As a guide managers and groups should be looking at the following characteristics; -
Is the recommendation or action high risk? This can be determined using the Trust matrix of risk Is the affected area high volume? Is the issue currently of high cost that would be improved by investment? Has the issue caused concern – this can be evidenced through the incidents or complaints amongst other data?
Further guidance can be found by contacting the Quality Improvement Team. Re-audits will provide evidence of shortfalls in making improvements following the original audit. Where shortfalls are identified a further action plan will be developed and escalation through the Board Assurance Framework will be completed. Head of Patient Experience will be responsible for ensuring this is done.
14 Involvement of Service Users and Carers Patients and their carers often assess their quality of care in a different way from health professionals. This provides a unique perspective based on personal experience of our services and helps to develop the delivery and design of our services. Audit results can provide patients and their carers with increased knowledge and awareness of the quality of our care. This allows them to make more informed choices in their treatment Page 23 of 42
pathways and increases confidence in our services. The contribution of the patients and carers is valid and an important addition to our understanding and progression of audit results. As we move our monitoring and processes to outcomes focussed systems the feedback and involvement of patients will be invaluable. The role of the patient in a particular audit must be clear, widely communicated and understood to avoid any involvement becoming „tokenistic‟. There a number of ways to involve patients and carers in clinical audit and these will differ dependent upon the audit aims and objectives. The Trust supports and recognises the following types of engagement and encourages staff to utilise these wherever possible; 14.1 Audit Selection The audit is identified as a result of patient experience feedback or an issue identified through the incident reporting processes. Whilst this is a passive form of engagement it is fundamental in seeking improvements to issues that impact directly upon patients and their carers. 14.2 Workshops As part of the audit process a workshop is convened for patients and carers to participate in the data collection, analysis or action planning process. This can be arranged with the support of the Quality Team or the Patient Engagement services. This will include the Trust Effectiveness Days which have Service User and Carer involvement. 14.3 Presentations In sharing results of an audit the auditor or audit sponsor will use the established patient forums such as the Patient Experience Committee, Service User and Carer Forum to deliver the results and findings. This provides evidence of sharing the information and encouraging engagement in the audit cycle and offers additional input into planning and quality improvement following the audit. 14.4 Data Collection Some audits may identify benefits for peer collection of data. This may include patient or carer representatives seeking views and data collection through surveys or health records checks. Where patients are involved in audit the reimbursement rates will be in line with our volunteering policy. It may be necessary to seek additional advice or guidance on this and you may contact the Quality Team on
[email protected] for further information. HQIP also has several resources for patient involvement in audit available at http://hqip.org.uk/patient-and-publicengagement-2/
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15
Doctors in Training and Medical Students We are committed to involving and working collaboratively with local academic bodies to ensure our doctors in training are able to complete their requirements for clinical audit in their training. Guidance will initially be provided through the induction training and trainees will be offered the Clinical Audit Programme for that year. This document will outline the approach to be taken in line with this policy and give a contact name for the clinical audit leads. All doctors in training who undertake audit are expected to apply the requirements of this policy and complete a full audit cycle. We acknowledge that for some it will be a challenge and we recommend early discussions with the clinical supervisors, Quality Team and the clinical audit lead to ensure issues are kept to a minimum and effective planning is achieved . In line with the Foundation Curriculum the Trust expects all doctors in training to;
Understand and have knowledge of the audit cycle and relevance to developing patient care, clinical governance and risk management.
Know how to use and identify data sources for audit.
Understand the rules applying to data confidentiality and the audit cycle‟s relationship to quality improvement and outcomes.
Demonstrate their participation in an audit project and make links to their learning and professional development portfolio with the approval of their clinical supervisor.
Be able to describe the rationale for choosing their audit, the findings and their recommended changes to practice, how these changes could be implemented, what they have learnt from conducting their audit and any additional training identified by the audit completed.
In addition to the Clinical Audit Programme, this policy and guidance from their Clinical Supervisors the psychiatry trainees should also be directed to the following sites by their clinical supervisors;
www.schoolofpsychiatry.net www.rcpsych.ac.uk
These two sites set out the curriculum requirements for psychiatry trainees in relation to audit, and what capabilities they will be expected to demonstrate at each level in order to progress through their training.
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Additional guidance may be found at: http://www.clinicalaudits.com/index.php/ojca
http://hqip.org.uk/assets/5-HQIP-CA-PD-026-Guide-to-Involving-Junior-Doctorsin-Clinical-Audit-19-April-2010.pdf
http://www.hqip.org.uk/guidance-support/online-learning-resources.html
The Trust encourages medical students on placement to become involved with audit at an appropriate level for their stage of training, under the supervision of their clinical supervisor.
16 Monitoring and Annual Reports The Trust will ensure all audit activity is included in the Quality Account each year. There will also be a separate Audit Report produced and presented to the Integrated Risk Management & Clinical Governance Committee and the Quality Board. This will be produced by the Quality Improvement Team and will include: -
Introduction and background Executive Summary Overview of audit activity Education and Training Public Involvement Monitoring Recommendations and Goals for coming year Summary report of audit projects (including reasons for non-completion) Monitoring compliance of this policy and any associated standard operating procedures
17 Ethics and Consent By definition, clinical audit projects should not require formal approval from the Research Ethics Committee. The clinical audit programme in the Trust is completed with the principle that the process will do good and not harm to any person accessing our services. Audit is therefore conducted within an ethical framework that complies with the four principles: 1. There is a benefit to existing or future patients or others that outweighs potential burdens or risks. 2. Each patient‟s right to self-determination is respected. 3. Each patient‟s privacy and confidentiality are preserved. 4. The activity is fairly distributed across patient groups. The Integrated Risk Management & Clinical Governance Committee is responsible for the ethical oversight of clinical audit across the organisation and any person who has concerns regarding the ethics of clinical audit should refer them to the Chair of the committee. Page 26 of 42
18 Information governance: confidentiality
collection,
storage
and
retention
of
data
and
All clinical audits must adhere to NHS Information Governance policies and standards. Audits should pay special attention to 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
All clinical audit data must be anonymised without exception. If any member of staff believes they need to include patient identifiable details during data collection they should contact the Quality Improvement Team who will discuss the individual circumstances with the Information Governance Lead. Staff confidentiality is expected in all meetings and discussion relating to clinical audit. The anonymisation of data includes staff details. The purpose of clinical audit is quality assurance and improvement and not a performance management tool. The Trust accepts that in some audits it is unavoidable that staff may be aware of which clinicians or teams are involved and in this case they should be made aware of the results and given opportunity to discuss the report prior to wider dissemination. Advice relating to this should be sought from the Quality Improvement team if necessary. 18.1 Confidentiality Agreements There may be occasions when the Trust engages individuals in its clinical audit activities who are not directly employed by the Trust, e.g. staff who are on honorary contracts, volunteers, indeed patients and the public. It is important that they understand the “rules” which apply to the practice of clinical audit, so training is an important consideration. It is also recommended that individuals in this situation sign a confidentiality agreement, an example can be requested from the Quality Improvement Team and once signed should be returned to them for storage.
19 Implementation of this Policy A timetable and schedule for all related documents will be presented to the Quality Board for approval with the annual Clinical Audit Programme in March each year. The Quality Improvement Team will be responsible for implementing and advising staff on this policy as required. Training will be provided as set out in the Training Needs Analysis which is led by the Learning and Development Team.
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A University Teaching Trust
Appendix 1 Initial Scan for Privacy Impact Assessment requirement Proposed Project/proposed change/:
Clinical Audit Policy V5 2013 - 2016
Date:
Section
Technology
Identity
Multiple organisations
Data
Requirement
Yes
No
Please rate 1 (low) to 5 (high)
√
(1) Does the project/proposed change apply to new or additional information technologies that have substantial potential for privacy intrusion?
√
(2) Does the project/proposed change involve new identifiers, re-use of existing identifiers, or intrusive identification, identity authentication or identity management processes?
√
(3) Might the project/proposed change have the effect of denying anonymity and pseudonymity, or converting transactions that could previously be conducted anonymously or pseudonymously into identified transactions?
√
(4) Does the project/proposed change involve multiple organisations, whether they are government agencies (e.g. in 'joined-up government' initiatives) or private sector organisations (e.g. as outsourced service providers or as 'business partners')?
√
(5) Does the project/proposed change involve new or significantly changed handling of personal data that is of particular concern to individuals?
√
(6) Does the project/proposed change involve new or significantly changed handling of a considerable amount of personal data about each individual in the database?
√
(7) Does the project/proposed change involve new or significantly changed handling of personal data about a large number of individuals?
√
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Exemptions and exceptions
(8) Does the project/proposed change involve new or significantly changed consolidation, inter-linking, cross referencing or matching of personal data from multiple sources?
√
(9) Does the project/proposed change relate to data processing which is in any way exempt from legislative privacy protections?
√
(10) Does the project/proposed change justification include significant contributions to public security measures?
√
(11) Does the project/proposed change involve systematic disclosure of personal data to, or access by, third parties that are not subject to comparable privacy regulation?
√
Contact details (This should be the individual most qualified to respond to questions regarding the PIA) Name, Title
Patrick Cahoon, Head of Patient Experience
Branch / Division
Governance
Phone Number
0161 882 1103
E-Mail
[email protected]
The Privacy Impact Assessment should be returned to the Information Governance Manager for approval at TIGG Decision Approved by TIGG/Further review required/Full Scale PIA/Small Scale PIA (delete not applicable)
Signed Name
Date
The Privacy Impact Assessment Procedure should now be completed accordingly and results filed in the change/project/proposed change record
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A University Teaching Trust
Appendix 2 Approving Groups Document Checklist Checklist for the Review and Approval of Procedural Documents To be completed and attached to any document which guides practice when submitted to the appropriate committee or group for consideration and approval. Title of Procedural Document: Clinical Audit Policy 2013 – 2016 V5 Author: Head of Patient Experience Yes/No/ Title of document being reviewed:
Unsure/
Comments
N/A Document Control Sheet Is the title clear and unambiguous?
Y
Is it clear whether the document is a guideline, policy, protocol or strategy?
Y
Has the document control sheet been filled in full
Y
Rationale Are reasons for development of the document clear?
Y
Consultation Process Is there evidence of consultation with stakeholders and users?
Y
Was the consultation longer than the minimum 2 weeks?
Y
3 weeks and 4 days
Content Is the objective of the document clear?
Y
Is an executive summary included
Y
Are the statements clear and unambiguous?
Y
Is the document in the required format (font Arial 11 or 12)
Y
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Yes/No/ Title of document being reviewed:
Unsure/
Comments
N/A In the approving groups opinion does the statement on the equality duty satisfy the Trusts requirements for compliance with the NHS Equality Delivery System?
Y
Dissemination and Implementation Is there an outline/plan to identify how this will be done? If not the approving group should agree with the author
Y
Does the plan include the necessary training/support to ensure compliance?
Y
Process for Monitoring Compliance Are there measurable standards or KPIs to support monitoring compliance of the document?
Y
Section 19
Is there a plan to review or audit compliance with the document?
Y
Compliance will be monitored in the annual audit report
If there is a plan has this been added to the agenda / yearly plans for the relevant group
Annual audit report will be completed and presented to the Quality Board Y
Clinical Audit is included in the triangulated quarterly reports to Quality Board
Review Date Is the review date identified?
Y
Is the frequency of review identified? If so, is it acceptable? Trust standard is 3 years
Y
3 years
Y
Head of Patient Experience
Overall Responsibility for the Document Is it clear who will be responsible for coordinating the dissemination, implementation and review of the documentation?
If the answers to all of the above are satisfactory the group / committee should approve the procedural document. This should be recorded in the minutes of this meeting and the approved document and any additional information should be sent to Head of Patient Experience –
[email protected] to facilitate ratification. Page 31 of 42
Yes/No/ Title of document being reviewed:
Unsure/
Comments
N/A Name (Chair)
Claire McBeath
Committee / Group / Executive Lead
Quality Board
Date group
of 12/2/2013
Please note the minutes of the approving group may be checked as part of the monitoring requirements. As a minimum they should record the name of the procedural document and whether the approval was with or without prior amendment to the document.
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A University Teaching Trust
Appendix 3
Quality Improvement Project Registration Form A form must be completed for ALL service and clinical audit projects Please return this form and accompanying documents to:
[email protected] (Registration forms should be submitted at least 4 weeks prior to the commencement of an audit) If this is the first time you have contacted the Quality Team about your project you may want to discuss this with us or complete an initial project form Proposed Project Title: Project Type: Contact Details Sponsor Team/Location/Care Group Auditor Name Team/Location/Care Group Approving Group
Scope of Audit Additional Information
Put in the title of your audit – make sure it’s clear as we will use the title to store your audit Audit / Evaluation / Baseline Review / Scoping [Who is the lead responsible for backing your audit?] [Person who will be completing the audit]
Job Title: Email address: Job Title:
Email address: [This is the group who will receive your audit report and approve / manage any action plans Without this group your audit cannot be registered] Choose an item. If the audit will cover more than one area please specify: Location / Teams /Locality If the audit will cover more than one area please specify:
Timelines/Initial Plan Start Date for data DD/MM/YY collection
End date for data collection
Where the audit appears on the Clinical Audit Programme Specify the project number and title: Select the primary reason: If there is more than one reason for this audit please state Is this a reaudit?
DD/MM/YY
Expected completion of audit report
DD/MM/YY
Choose an item.
Yes / No Assurance of Previous Audit:
Provide any additional detail you may have to support reason: This should include reference to other reports, websites, DATIX details, minutes of meetings be as specific as possible, if this is a re-audit specify project number and assurance level of previous audit
All audits need to align to a primary CQC outcome:
Choose an item. Page 33 of 42
Provide details of your audit; include why you have selected the audit, what the benefits may be to your practice, service or the Trust approach, aims and objectives that you have set for the audit
Stakeholders: Who may be affected by your audit, which groups may be interested in results
Service User / Carer Involvement: have you considered how you may involve service users or carers in this audit? This could include: Use of patient experience data or discussion in identifying your audit topic (passive), Planning a workshop for patients and carers to participate in data collection, analysis or action planning, working with Service Users and carers to prepare your presentation or deliver your presentation at a SU/C group, involvement in data collections etc. Explain your reasons below (if you need support on this including advice of how to involve service users or carers please state this in the box below)
Methodology: Population Size Time period that sample From: DD/MM/YY (approx) will fall into To: DD/MM/YY Not Applicable Sample Size (approximate) To calculate sample size you can use http://www.raosoft.com/samplesize.html this has guidance on how to do this. We do check sample sizes and confidence levels as part of our quality assurance processes. What is your selection criteria? I.e. groups of staff / patients, diagnosis, location, treatment, admission area, CPA Data Collection How will you be collecting the data Choose an item. (provide a copy of this if available) How will data be returned to the auditor (if Choose an item. applicable)
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Costing / Financial Impact This will assist you in understanding the impact on resource and capacity and measure this against the planned benefits/outcomes Estimated Number of Hours Cost Include data collection, report and Band 6 Costing.xlsx Junior Doctor Audit presentation time Costing.xlsx
Job Title Junior Doctor / Trainee Band 6 Other: Total Support needed from the Quality Team What assistance do you feel Choose an item. you might need in undertaking If you need more than one type of support please include details: this audit? Trust Library Resource Support Have you carried out a literature search to locate relevant guidelines and standards? For training, Athens Passwords or to request a literature search contact the Trust Library Services. Email address :
[email protected] Standards Please note without this section being completed we cannot register your audit e.g. Records Management Section 11.3 1 The NHS Number is included in Policy v5 2012 Page 17 (Question 1 of the attached (of the policy) all clinical correspondence proforma asks ‘was the NHS Number on the letter to GP?’
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DECLARATION Please email the completed electronic copy of this form to
[email protected] to evidence your acceptance of this declaration, Make sure you copy in your sponsor and any stakeholders you have already discussed the audit with as evidence. We the sponsor and lead auditor agree to abide by the following terms and conditions:
To conduct the audit (once approved) in a timely fashion. Ensure that data is collected in accordance with the methodology identified. Participate in the production of an audit report. This will include writing an introduction and summarizing the audit findings. Nominate a replacement audit lead if you should leave the Trust before the completion of the project. Accept responsibility for developing an action plan in response to the audit findings and implementing changes recommended in the action plan, if applicable. Adhere to data protection requirements and Caldicott principles and ensure all audit data remains anonymous and is only used for the purpose of this project.
You are now ready to submit your audit registration form. You must attach the following if available: Item Proforma Data Collection Tool Standards / Guidance
Rationale if not available / planned availability date
(you can just add links here rather than send the full attachment if it is available electronically) If you haven’t already done so you should make your local care group, team or committee aware of your plans to complete this audit.
The Quality Team will respond to you within 14 days
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A University Teaching Trust
Appendix 4
MEDICAL DIRECTORATE
(Re-) Audit title
Audit Project Team Chief Auditor, Designation: Principal Auditor 1, Designation: Principal Auditor 2, Designation: (delete/add as appropriate) Date report completed:
Previous Review
Current Review
Overall Assurance Opinion for this Review
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Contents Assurance Ratings ............................................................................................................................... 39 Rational for Assurance Level ............................................................................................................... 39 1.
Executive Summary ...................................................................................................................... 40
2.
Background................................................................................................................................... 40
3.
Aims & Objectives ......................................................................................................................... 40
4.
Summary of Outcomes and Assurance Level(s) ........................................................................... 40
5.
Standards ..................................................................................................................................... 40
6.
Action Taken on Previous Results (only applicable for re-audits) .................................................. 40
7.
Methodology ................................................................................................................................. 40
8.
Findings / Results ......................................................................................................................... 41
9.
Service Strengths.......................................................................................................................... 41
10. Service Recommendations ........................................................................................................... 41 11. Outcomes and Benefits ................................................................................................................. 41 12. Action Plan.................................................................................................................................... 41
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Level of Assurance is: High
Significant
Limited
No
Assurance Ratings Level of assurance
Description
High
The review did not identify any weaknesses that would impact on the achievement of the key system, function or process objectives. Therefore we can conclude that key controls have been adequately designed and are operating effectively to deliver the key objectives of the system, function or process. As a result, a high level of assurance can be given that the system of control is designed to meet the Trust‟s objectives and controls are consistently applied over [name of review] at the time of our audit.
Significant
There are some weaknesses in the design and/or operation of controls, however the likely impact of these weaknesses on the achievement of the key system, function or process objectives is not expected to be significant. Furthermore, these weaknesses are unlikely to impact upon the achievement of organisational objectives. As a result significant assurance can be given that there is a generally sound system of internal control, designed to meet the organisation's objectives, and that controls are generally being applied consistently at the time of our audit.
Limited
There are weaknesses in the design and / or operation of controls which could have a significant impact on the achievement of the key system, function or process objectives but should not have a significant impact on the achievement of organisational objectives. As a result there is limited assurance as weaknesses in the design and/or inconsistent application of controls over [name of review] at the time of our audit put the achievement of the system‟s objectives at risk in a number of the areas reviewed .
No
There are weaknesses in the design and/or operation of controls which not only have a significant impact on the achievement of key system, function or process objectives but may put at risk the achievement of organisation objectives. As a result there is no assurance as weaknesses in control, and/or consistent non-compliance with key controls over [name of review] at the time of our audit, could result (have resulted) in failure to achieve the organisation‟s objectives in the areas reviewed.
Rational for Assurance Level Please provide a brief but comprehensive rational for the level of assurance you have assigned.
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1. Executive Summary Please provide a brief but comprehensive synopsis of the audit, its key findings and action points.
1.1. 2. Background Some background information about the service and the reason for the audit. Information about the topic being audited should be included along with the date the audit started and the date of the report. Include an explanation of the specific problem/issue being addressed e.g. number of service users who have had a physical examination completed.
2.1. 3. Aims & Objectives Information about the area that is being audited and what the area of practice the audit will be measuring.
3.1.
4. Summary of Outcomes and Assurance Level(s) Provide a brief overview of the audit outcomes and assurance levels – if there is more than one standard the assurance level of each standard
4.1.
5. Standards This audit was undertaken in order to evidence compliance with the following standards and best practice guidance: (examples) The National Dementia Strategy CG42 Dementia: NICE Guideline N.B. Please check with the Service and Clinical Audit Department if you are unsure
5.1. 6. Action Taken on Previous Results (only applicable for re-audits) Look at the Action Plan from the previous audit, list all the actions recommended and explain what has happened with each action since the previous audit.
6.1.
7. Methodology Describe how the audit was carried out, how the data was collected e.g. electronic / paper records, data collection form, etc. If you used an audit tool describe how you decided which criteria to include. If the audit involves any other agencies please give details in this section. If the audit involves patients, e.g. patient surveys, please give details.
7.1.
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8. Findings / Results Present the information in a clear and accurate way. The use of tables and bar charts can illustrate your findings effectively thus enhancing your report. Summarise the important findings from the audit. N.B. Include the sample size of the audit, the number involved. If a patient survey, record how many were sent out and how many were returned.
8.1. 9. Service Strengths Comment on the strengths of the service shown by the audit e.g. positive patient comments from surveys, areas that have achieved 90% plus compliance.
9.1. 10. Service Recommendations List the areas where improvements are highlighted by the results and recommendations for change i.e. those which show poor compliance with the criteria you have set. You must include an overall opinion on the results of the audit providing a Level of assurance statement that standards measured against have been met and/or ways in which compliance can be improved e.g. ‘Significant assurance can be given that there is a sound system of internal control, designed to meet the organisation’s objectives and that controls are being applied consistently.’ This should be followed by a list of examples that form the basis for your opinion, followed by information supporting the opinion. The table below illustrates the four levels of assurance along with a description for each. An assurance grading e.g. ‘Significant Assurance’ or ‘Limited Assurance’ must also be indicated on the cover of the report. Consideration should also be given to any risks highlighted in the audit and cited within the recommendations and action plan.
10.1.
11. Outcomes and Benefits Highlight the outcomes and benefits obtained.
11.1.
12. Action Plan Complete an Action Plan outlining the actions planned and identify who will take responsibility for the actions. You should do this at a meeting with all staff who have been involved in the audit and those who might be affected by any changes that are planned. The plan should specify when or how a re-audit should be undertaken to monitor whether changes have taken place and if they have been effective.
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[ACTION
PLAN NAME] – Action Plan 14/15
Date Action Plan Developed: Action Plans only valid until the end of the financial year. Actions beyond this should be considered for business plans or will need to be submitted for inclusion in the following years Group or Committee action plan
Issue This must be specific and reference the section or page number of the accompanying document. This must include any other sources where the issue has been identified such as complaints, datix reports
Theme Specify a theme this action relates to Themes to be taken from CQC Outcomes to improve standardisation across service areas and compliance checks
Care Group / Committee Approval Date: (specify which CG/C)
Ref Care Group/Area: Number: AMH/WB/LL/P/Psy/SC Ward/Team
Purpose: SUI/Rule 43/ SCR/ Visit/ Complaint/ Audit/ Survey / Other (specify)
Name of Manager (Band 7>): Completing action plan and responsible for delivery and distribution
Consultation with: Specify any individuals or groups the issues identified in this plan and possible actions have been discussed with. This must include anyone identified in lead column. This should include the date you consulted / tried to consult
Action
Outcome and Benefits
Method of Measurement
Lead / Involved
Target Date
Evidence
This must be specific and realistic. Actions identified here will need to be monitored and evidenced. Actions requiring a change in operational approach or Trust policy must be checked with a specialist lead in that area. Learning should be demonstrated through the solution offered and should include the wider impact of the issue and related action.
All actions must result in improvement to our service. Details should be provided of which outcomes will be provided by completion of this action.
This should include specific measurements and how this will be completed. The Trust aims to improve services in line with QIPP. The location of measurement should also be included i.e. reportsplus data, audit (where this is a 'new audit' this should include a check that it cannot be linked to an audit already on the Clinical Audit Programme for the year)
The action must be assigned to a senior manager, care group, Trust Committee or Executive Director only. Others may be included as ‘involved’ to reflect them completing delegated work.
Action plans will only remain valid until the end of the financial year. Actions expected beyond this should be reflected as information/data being passed to project leads i.e. CIP’s or 3D project leads or will need to be submitted for inclusion in the following years Group or Committee action plan All actions should be completed in the shortest possible timescale but must be realistic in their aims.
This area should include links to documents that provide assurance that the action has been completed. This may be minutes, training presentations or a detailed description of the actions taken
Reasons if not Approved:
Review Dates (lead manager responsibility to complete)
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