South Staffordshire and Shropshire Healthcare NHS Foundation Trust

Document Version Control Document Type and Title:

Clinical Audit Policy

Authorised Document Category:

YELLOW - CLINICAL

New or Replacing:

Replacing C-YEL-gen-08 v1.1 2010

Document Reference:

C-YEL-gen-08

Version No.

V2.0

Implementation Date:

March 2015

Document Owner:

Steven Hazeldine, Clinical Audit Team Leader

Approving Body:

Quality Governance Committee

Approval Date:

12th February 2015

Ratifying Body:

Board of Directors

Ratified Date:

26th February 2015

Committee, Group or Individual Monitoring the Document:

Quality Governance Committee

Review Date:

March 2018

Key Words:

Clinical, Audit, Data Protection

Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

CONTENTS 1.

Introduction ....................................................................................................... 3

2.

Purpose .............................................................................................................. 3

3.

Scope ................................................................................................................. 5

4.

Definitions .......................................................................................................... 5

5.

Clinical Audit Process ....................................................................................... 6

6.

Prioritisation & Forward Planning .................................................................... 7

7.

Procedure for Undertaking Clinical Audit ........................................................ 9

8.

Duties & Responsibilities ................................................................................ 10

9.

Audit Report Format ........................................................................................ 13

10.

Compliance Indicators .................................................................................... 13

11.

Training ............................................................................................................ 13

12.

Confidentiality, Security & Data Protection ................................................... 14

13.

Service User, Carer and Stakeholder Involvement ....................................... 15

14.

Making and Sustaining Improvements .......................................................... 16

15.

Clinical Audit and Risk .................................................................................... 17

16.

Feedback / Sharing .......................................................................................... 17

17.

Monitoring Compliance ................................................................................... 19

18.

References ....................................................................................................... 21

19.

Glossary of Acronyms Used……………………………………………………… 21

Appendix One – Clinical Audit Proposal Form Appendix Two – Audit Report Template

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Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

1

Introduction The standard definition of clinical audit, and that endorsed by both NICE and the Care Quality Commission is that: “Clinical audit is a quality improvement process that seeks to improve the patient care and outcomes through systematic review of care against explicit criteria and the implementation of change”. Clinical audit was introduced to the NHS as a quality improvement process in 1989 through the Department of Health White Paper entitled “Working for Patients”. Since this time clinical audit has become a firmly embedded part of the NHS landscape and is a key element of the clinical governance framework. South Staffordshire and Shropshire Healthcare NHS Foundation Trust is committed to continually improving clinical practice and the standards of its service delivery and therefore acknowledges the importance of clinical audit activities as a vehicle of driving forward excellence in care. Likewise the Trust acknowledges the importance of and need to maintain, clear links between the planning and reporting of its clinical audit and its risk and performance management frameworks. The Trust recognises that its clinical audit programme can only be achieved as part of its overall governance framework arrangements and therefore this policy document has been developed to provide robust guidance for all staff undertaking clinical audit activities as part of their day-to-day working practice.

2

Purpose This clinical audit policy has been developed in order to: •

Ensure that all clinical audit activity is undertaken in line with methodologies endorsed by external validating authorities including; National Institute for Health & Clinical Excellence, the Care Quality Commission, the NHS Litigation Authority (Risk Management Standards)

•

Ensure that all clinical audit projects are driven by appropriate national, regional and local priorities and fully integrated within the organisation’s wider Governance agenda.

•

Ensure clinical audit is embedded as an organisational wide activity ensuring that current approaches to clinical practice are reviewed against predetermined standards, leading to change and improvement in care.

•

Promote continual development of an effective governance culture which encourages clinical audit activities in order to monitor and improve both the care experience and treatment outcomes.

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Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

•

Provide an organisational wide framework for all clinical staff involved in clinical audit. Ensuring they are supported in undertaking, and learning from, clinical audit activities.

•

To encourage multi-professional and/or multi-agency clinical audit activities so as to broaden both the scope and potential for learning

•

Ensure that all clinical audit activity is centrally registered, coordinated, monitored and reported on systematically and effectively so as to maximize the potential for improvement and learning.

•

To positively encourage service user and/or carer involvement within clinical audit activities in order to enrich outcomes and improvement.

All staff conducting clinical audit are required to follow the Clinical Audit Principles, of which there are 7 key areas. These 7 areas when taken together underwrite the framework for responsive and responsible audit. The 7 areas are detailed in figure 1 below. Figure 1 Collaboration & Partnerships

Dissemination of Findings

Training & Education

Clinical Audit Ethical & Data Protection Responsibilities

Ensuring Quality

Engaging Stakeholders

Informing Service Practice

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Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

3

Scope This policy applies to all South Staffordshire and Shropshire Healthcare NHS Foundation Trust staff involved in clinical audit activity and evaluation projects. This policy does not cover those projects which are deemed to be research activity – anyone undertaking research activity should refer to the Trust Research Governance Policy.

4

Definitions The term ‘audit’ is often confused with ‘research’. These two terms are often interchanged, but they are not mutually inclusive. It is important to distinguish the difference between research and audit projects as the processes by which they gain approval to proceed differ. Some useful pointers to distinguish between research and audit are summarised on the Royal College of Psychiatrists web site and are shown in the table below.

Table 1 Differences between research and clinical audit. Adapted from (1991) and FirthCozens (1993) Research Audit Aims to establish what is best practice Is designed so that it can be replicated and so that its results can be generalized to other similar groups Aims to generate new knowledge /increase the sum of knowledge

Aims to evaluate how close practice is to best practice and to identify ways of improving the quality of health care provided Is specific and local to one particular patient group – results are not transferable to other settings Aims to improve services

Is usually initiated by researchers

Is usually led by service providers

Is theory driven

Is practice based

Is a one off study

Is an ongoing process

May involve allocating service users randomly to different treatment groups

Never involves allocating patients randomly to different treatment groups

May involve admission to a placebo

Never involves a placebo treatment

May involve a completely new treatment

Never involves a completely new treatment

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Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

All research projects must receive approval from a Research Ethics Committee and the Research and Development department before proceeding. All audit projects must be registered with the Trust Clinical Audit Department as detailed within section 7 of this policy.

5

Clinical Audit Process

5.1

Clinical Audit Cycle and Stages The overall audit process is commonly referred to as the Clinical Audit Cycle. Within the cycle there are stages that follow a systematic process of establishing best practice, measuring care against criteria, taking action to improve care, and monitoring to sustain improvement. The spiral suggests that as the process continues each cycle aspires to a higher level of quality. The Clinical Audit Cycle and key stages are highlighted in figure 2 and 3 below. Figure 2: The Clinical Audit Cycle Principles for Best Practice in Clinical Audit (NICE 2002)

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Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

Figure 3: The Key stages of Clinical Audit Principles for Best Practice in Clinical Audit (NICE 2002)

6

Prioritisation & Forward Planning Each year the Trust develops its annual clinical audit forward programme which consists of the Trust’s priorities and key drivers for the year. The Trust forward audit plan is developed through consultation with each of the clinical directorates and includes the Performance Development Team. The forward audit plan is presented to the Audit Committee who are responsible for assuring alignment to the Trust Assurance Plan and Risk Register. It is then agreed by the Quality Governance Committee (QGC) before being signed off at the Trust Board. Clinical audit project priorities are determined by the drivers they are required to fulfill. The forward audit programme consists of national, strategic, Trust and directorate driven projects and these are prioritised according to four levels of priority as highlighted in T able 2. Clinical directorates must ensure they have included key local drivers including risk registers, effectiveness of SUI action plans, and delivery of Quality Accounts. Once the clinical directorates have identified the audit topics, the audit team and managers from the Performance Development Team meet to identify which key national drivers require evidence through the audit programme. Wherever possible these elements will be incorporated into the audits already put forward. Where this is not possible further audits will be identified to be included in the forward audit programme. Within the forward audit programme the elements of the national drivers which the audit is addressing must be included e.g. CQC Essential Standards Page 7 of 31

Clinical Audit Policy/C-YEL-gen-08v2.0 March 2016

of Quality and Safety Outcome 2c. This review must include the timeframe for delivery. The forward audit programme provides an outline of the key clinical audit activity for the financial year. Although the plan is predetermined by known priority topics the audit programme is not fixed and additional projects will be included or removed as priorities change throughout the year. Table 2 Level 1

Examples • National Clinical Audit Programme • National Patient Survey. • National Institute for Health & Clinical Excellence (NICE) • Care Quality Commission (including MHA Commission) • CQUINs • Risk Register

2

• • • • • • • • • •

Assurance Framework Confidential Enquiries Complaints & PALS Serious Untoward Incidents Commissioning requirements Quality Accounts RP Other national initiatives External Accreditation Regional audit projects. Service Improvement

•

Locally initiated audits not covered by the above

3

4

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7

Procedure for Undertaking Clinical Audits All clinical audit projects undertaken within the Trust must be developed and registered in accordance with the agreed clinical audit procedure as detailed in Figure 4 below.

Figure 4

Process for Agreeing Annual Forward Programme Need for clinical audit identified by directorates and various trust wide groups/committees 

Clinical leads, approximate timescale, key drivers, links to risk/CQC, priority level – all agreed 

Programme arranged to identify committee/group responsible for monitoring project progress and agreeing initial actions, including directorates, Medicines, Nursing, Mental Health Act. Proposed projects allocated a project number 

Programme shared with Performance Development Team to ensure all necessary key national drivers are incorporated. 

Programme approved by CAPG and QGC 

Prior to commencing projects on the programme a proposal for each is to be completed by the clinical project lead and approved as per the process for all new projects (see below)

Process for Undertaking Clinical Audit Projects In addition to topics identified at the start of the financial year, new topics can be added to the forward programme as priorities change and different needs dictate. The process for undertaking newly identified (‘in year’)audit projects is the same. Clinical Audit Lead completes Trust Clinical Audit Project Registration Form (Annex A) and submits this to the Clinical Audit Team for review 

Clinical Audit Team reviews the priority of the submitted Clinical Audit Project against the key drivers identified and scores it against the Trusts agreed prioritisation matrix. 

Audit project proposal form to be taken by Clinical Audit team to relevant directorate governance / quality group to agree methodology and for approval to proceed with audit project 

Audit project proposal to be shared at Clinical Audit Project Group (CAPG) for consideration, modification if required and for final approval 

Audit project registration details to be entered onto Clinical Audit database, Clinical Audit support to be identified and the project folder set up on the clinical audit shared I:drive 

Clinical Audit Lead formally commences the clinical audit project and ensures that all stages of the clinical audit cycle are completed. Clinical Audit support offers assistance and support as agreed 

Draft clinical audit report completed, including recommendations for improvement and proposed re-audit date. Clinical audit report summary to be presented at Directorate governance/ quality group as well as other relevant forums for agreement/approval of recommendations / actions. 

Completed projects are shared at the Clinical Audit Project Group for sign off and conformation of compliance indicator, ratification of action plan and consideration of any potential risks highlighted. 

Agreed actions and timescales to be entered onto Performance Plus 

Quarterly reports on progress against the forward audit programme, along with summaries of completed projects and action plans, are presented to the Quality Governance Committee.

8

Duties & Responsibilities

8.1

Trust Board The Trust Board role is to:

8.2

•

Drive quality assurance, compliance, internal audit and ‘closing the loop.’

•

Use clinical audit as a tool in strategic management; ensuring that the clinical audit plan is allied to broader interests and targets that the board needs to address.

•

Ensure that clinical audit activity is systematic and focused on locally identified risks as well as on national issues.

•

Receive regular reports from the Quality Governance Committee that are used as evidence in the assurance plan and Trust risk register.

•

Ensure that the recommendations of reviews and clinical audits are actioned, by seeking assurance from the Quality Governance Committee that improvements in care have been made.

Quality Governance Committee The Quality Governance Committee is responsible for:

8.3.

•

Providing assurance to the Trust Board that clinical audit activity is being carried out in line with the key drivers and the Trust Clinical Audit Policy.

•

Developing an annual clinical audit programme, this is based upon national and local priorities and activities.

•

Overseeing progress with the forward audit plan and resulting action plans.

Clinical Audit Project Group (CAPG) The Clinical Audit Project Group is: •

Charged by both the Trust Board and the Quality & Governance Committee to oversee and guide all clinical audit activities across the Trust, ensuring a robust process around the use of clinical audit

•

Responsible for overseeing the delivery of the forward audit plan/programme.

•

Responsible for providing regular assurance reports to the Quality Governance Committee, summarising all clinical audit activity. Page 10 of 31

8.4.

•

Responsible for ensuring robust local processes for the sharing of learning from local clinical audits across the Trust so as to maximize the potential for learning and quality improvement across the widest possible clinical audience.

•

Consider all project proposals prior to them being placed on the forward programme, particularly focusing on ensuring robust methodologies, appropriate scope/sample and link to other quality initiatives including risk.

•

Considering reports of completed projects, confirming the robustness of agreed actions agreeing levels of compliance indicators and linking with other quality initiatives as appropriate.

•

To co-ordinate the receipt, assessment, implementation and review of NICE Clinical Guidelines, including audit requirements.

Associate Director of Quality & Risk The Associate Director of Quality & Risk is responsible for:

8.5.

•

Ensuring that clinical audit is fully integrated into the wider Clinical Governance processes within the organisation.

•

Ensuring the provision of appropriate staff and structures within the Clinical Audit Department for actively supporting on-going clinical audit activities.

•

Ensuring the provision of appropriate local policies and guidance for clinical audit are developed, maintained and adopted within the Trust.

Clinical Audit Manager The Clinical Audit Manager is responsible for: •

Ensuring that all clinical staff wishing to undertake clinical audit activities receive appropriate support and guidance in accordance with the Clinical Audit policy.

•

Management of the Clinical Audit Team and their role in supporting, and where necessary leading, specific clinical audits.

•

Working directly with Service Heads, Managers and frontline clinical staff to both ensure the development of clinical audit work and ensure that appropriate lessons or recommendations are embedded effectively into day-to-day clinical practice and service delivery.

•

Overseeing the development and maintenance of a comprehensive clinical audit activities database to all Operational Services.

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• 8.6.

Providing training in clinical audit principles, methodology and skills, as part of the ongoing training programme

Clinical Audit Team The Clinical Audit Team are responsible for:

8.7.

8.8.

8.9.

•

Facilitating and monitoring clinical audit projects across the Trust.

•

Supporting staff in developing and improving clinical audit skills and quality of audit projects.

•

Ensuring all clinical audit activities are used effectively to ensure improvements are made to patient care.

Named Clinical Audit Leads •

To work through all stages of the clinical audit cycle, keeping the rest of the clinical team informed on the progress of the audit, sharing result/ findings, highlighting recommendations for improving practice and developing a robust action plan for ensuring that this happens

•

Working with the Clinical Audit Department to identify how lessons learnt from clinical audit activity might be shared with other clinical teams and services so as to maximize the potential for learning and quality improvement across the widest possible clinical.

•

In light of the nature and complexity of these tasks it is essential that this Named Clinical Audit Lead is a suitably experienced and knowledgeable individual who has the necessary skills and knowledge to undertake this role.

All Managers of Clinical Teams/Services •

All Managers will support on-going clinical audit as part of the overall quality agenda.

•

Ensure that their teams embrace all aspects of the clinical audit cycle by ensuring that it is fully integrated into local structures and is fully supported by staff.

•

Ensuring that local clinical audit activity feeds into the Trust-wide Clinical Audit Plan.

All Clinical Staff •

To assess their compliance with all relevant clinical standards at all times and participate clinical audit activity designed to measure performance against such standards. Page 12 of 31

9

•

To ensure their own knowledge and awareness of the Trust clinical audit structures, processes and policies.

•

To attend any local clinical audit training and awareness sessions in order to promote and maintain their own professional knowledge and skills base.

Audit Report Format The format of all audit reports should be consistent throughout South Staffordshire and Shropshire Healthcare NHS Foundation Trust. Appendix 3 provides a template document which should be used. In addition, the Clinical Audit Manager should be consulted where any queries around the format arise.

10.

Compliance Indicators As part of a decision to present clinical audit reports in a similar way to internal audit each completed project is assigned a compliance indicator. The indicators are based around the risks associated with non-compliance with an example shown below: Compliance Indicator Scope – Brief description of sample/scope of audit

Green/Amber

In line with Clinical Audit procedures this audit has been assigned a ‘Green/Amber’ level of compliance, based on agreed targets.

Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated ….

Levels of compliance are discussed and suggested by the project leads and agreed by the CAPG. The indicators are aimed at providing an at a glance representation of any associated risks highlighted through the audit, particularly for high level forward programme progress reports.

11.

Training All clinical staff within the directorates should be engaged in clinical audit activity in order to develop their own capability around audit and effectiveness and support quality improvement. The Clinical Audit Team provide ‘Clinical Audit Training’ which is available to all staff within the Trust via •

Group training sessions – rolling programme Page 13 of 31

•

Bespoke training upon request

•

E-learning module

Junior doctors are encouraged to participate in clinical audit and to undertake any projects working with the clinical audit team, using Trust processes and templates. Junior doctors are a valuable resource in meeting the annual forward programme workload and it is therefore important that projects undertaken support the Trust priorities and are included in the processes for learning and sharing within the organisation. A member of the Clinical Audit Team continues to meet with Junior doctors at their induction to offer support and advice as well as outline processes for undertaking an audit.

12

Confidentiality, Security & Data Protection All data used for the purpose of clinical audit activities Staffordshire and Shropshire Healthcare ‘Caldicott ‘Protecting and Using Person Based Information’. required around the storage of patient identifiable means of post or telephone.

should comply with the South Policy’ and the HIS policy Particular consideration is data and data collection by

The six Caldicott principles provide a summary of how the security and confidentiality of data is ensured and are:

•

Justify the purpose(s)

•

Don’t use patient-identifiable information unless it is absolutely necessary

•

Use the minimum necessary patient-identifiable information

•

Access to patient-identifiable information should be on a strict need to know basis

•

Everyone should be aware of their responsibilities

•

Understand and with the law

comply

Of particular consideration when undertaking data collection for audit purposes is the collection of unnecessary information. Demographic data is not usually valid or useful (e.g. name, age, ethnicity, post code) unless for example guidance states the patient must be of a certain age, gender etc. There may on occasion be a need to Page 14 of 31

benchmark services provided by different localities requiring the recording of geographical details, however the need for this should be agreed with those teams involved at the start of a project. In only exceptional circumstances should patient names be recorded. If required a patient identification code can be used, if there may be a need to follow up or revisit a case at a later date. All data collected as part of clinical audit should be done in line with the Data Protection Act 1998. The General Medical Council (2000) also suggest the following approach is adhered to in line with the Data Protection Act, 1998.

•

When information is gathered directly from patients, auditors must explain why the information is needed and what will happen to it, before asking for the patient’s consent.

•

If information is obtained from medical records, either patients must consent to identifiable data being used, or a member of the healthcare team should make the information anonymous before it is used in audit.

•

If neither of these approaches is possible, it may be permissible for someone from outside the team, who is suitably trained and subject to a duty of confidentiality, to collect the data from the records and make it anonymous without seeking patient consent.

To ensure data protection requirements are adhered to, Clinical Audit Project Leads are advised to consult the Clinical Audit Team for clarification before commencing data collection.

13

Service User, Carer & Stakeholder Involvement In order to assure robustness of audit it is important that stakeholders are involved in the whole audit process from the design through to the carrying out of the action plans. At the commencement of an audit it is wise to carry out a brief mapping exercise of who the stake holders are and how they might be involved/influence the project. Key stakeholders include: o Service users and carers o Corporate services e.g. finance, facilities and estates, performance, Human Resources, Organisational Development, quality, research and risk departments Page 15 of 31

o Professional leads e.g. Psychology, Social Work, AHP, Nursing o Public involvement e.g. LINKS, Carers Association It is important that service users & carers are involved in ensuring, measuring and influencing the quality of service provided by the Trust. To this end the Clinical Audit Team participates in the following activities:  Service User & Carer Feedback On occasion, projects are undertaken and supported by the Clinical Audit Team that involve seeking service user and carer views regarding the services provided. This feedback is used to assess performance and also to influence areas for service improvement as well as areas of further audit work.  Service User & Carer Involvement In addition to ‘audits’ that involve service user and carer feedback, the audit database also documents projects initiated by service users and carers or where they are part of the steering group responsible for planning the project. The appropriate involvement of service users and carers on steering groups is encouraged by the team. When considering projects where patient feedback is taking place service users and carers with experience in the relevant part of the service should be involved in developing the audit tool and considering the results. Much of the work undertaken by the clinical audit team considers national standards with agreed methodologies, criteria etc. (e.g. NICE guidance). It may not be the best use of service user and carers time being involved in considering the roll out of such projects. It may however be worthwhile to consider the results.

• Annual Mental Health Survey By undertaking the distribution, collation and submission of the Care Quality Commission, Annual Mental Health Patient Survey the team are much closer and aware of the issues being raised. Where there has been involvement or consultation with service users or carers, this should be recorded and acknowledged in the final report as documented evidence of involvement.

14

Making and Sustaining Improvements Of key importance to all clinical audits is the delivery of sustainable quality improvement. In order to deliver this there are key components of the audit process which must be delivered:

•

The development and delivery of the action plan once the recommendations have been agreed these need to be written up as Page 16 of 31

SMART (specific, measurable, achievable, relevant, timed) actions and put on Performance Plus by the clinical audit team to monitor the delivery of the actions.

•

All Action Plans uploaded to Performance Plus will be monitored by the Clinical Audit Project Group.

•

Carry out a re-audit – once the action plan has been delivered a reaudit should take place to provide assurance that the actions delivered addressed the issues identified in the original audit.

The action plan documented within the final audit report should contain details of who will be undertaking specific actions and by when. The plan will also note the review date when all actions are expected to have been completed and outcomes can be documented by the Clinical Audit Team.

15

Clinical Audit and Risk Clinical audit activity is linked into the wider risk ‘agenda’ through a variety of means.

16



The clinical audit annual programme considers trust and service risk registers in order to ensure all audits identified as providing assurances of improvements/compliance are undertaken. Risk registers are regularly reviewed to ensure updates are reflected in the programme.



All proposals are considered by the CAPG ensuring any links with risk are identified.



Results of completed audits are considered by the CAPG where organizational risks around non-compliance are discussed and where appropriate additions made to risk registers. The clinical audit report template includes a prompt to consider any risks identified through the audit results.



A quarterly clinical audit progress report is shared at the Health & Safety Committee. The committee now incorporates the functions of the Risk Management Committee.

Feedback / Sharing Feeding back and sharing the results/findings of audits is an important part of the audit process. Good practice can be celebrated and attention drawn to areas for improvement and action plans raised. The action plan template within the clinical audit report template includes a section Page 17 of 31

to be completed, detailing how the audit results will be shared. The title page of the audit report also states which groups and committees the report is being shared with. It is important that teams participating in audits have results of audits they have participated in fed back and that where possible they are able to benchmark against similar teams. Progress reports summarizing completed audits at a number of committees and groups as shown in the flow chart overleaf.

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13.2. Process for Sharing and Learning Completed Project (Incl. action plan)

Medium for sharing

Progress Reports

Forum

Directorate Clinical Governance Groups

Full Report

Abstract

Committees e.g. Infection Control, MOC, CAPG, QGC, Audit Committee, SU & Carer Committee, H&S Committee

Feedback locally – Teams / Services / Professional Groups

External / Patient sharing

Post abstract on website / intranet

Annual Summary

Annual Report detailing activity through the year.

Outcomes are monitored through progress reports and logged on the team’s project database.

Poster

Events: Celebration days, Learning Lessons events, etc. Notice boards

17

Monitoring Compliance Overall monitoring of clinical audit activity in line with the Clinical Audit Policy will be coordinated by the Associate Director of Quality & Risk and the Quality Governance Committee. In order to ensure compliance with the document, the following monitoring will be undertaken:

Aspect of compliance or effectiveness being monitored

Monitoring method

Individual or department responsible for the monitoring

Frequency of the monitoring activity

Group / committee/ forum which will receive the findings/ monitoring report

Committee / individual responsible for ensuring that the actions are completed

A. Duties

Personal Development Review

Manager

Annually

N/A

Manager and member of Individual

B. Process for setting priorities for clinical Audit programme including participation in local and national clinical audit

Monitoring of Directorate Audit Activity

Divisional /directorat e audit lead (rep at CAPG)

Monthly

CEOG

QGC

C. Process for ensuring that audit tools reflect the standards set out in the organisation’s approved document

Review Audit Activity

Monthly

QGC

CAPG Review Audit Activity

CAPG Monthly

D. Process for disseminating audit Results/Reports

Audit of Activity

Clinical Audit Manager

Quarterly

E. Format for all audit reports i.e. methodology, conclusions, action plans, etc.

Audit of Activity

Clinical Audit Manager

Quarterly

F. Process for making improvements

Audit of Activity

Clinical Audit Manager

Quarterly

G. Process for monitoring action plans and carrying out re- audits

Audit of Activity

Clinical Audit Manager

Quarterly

H. Role and function of the CAPG

Review terms of reference

QGC

Annual

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Audit Committee

Methodologies to be used to monitor clinical audit activity include: • Directorate audit activity will be monitored on a monthly basis through the Directorate governance meetings. The audit team will produce monthly project progress reports for each directorate for sharing and discussion at operational/governance groups. • The Clinical Audit Project Group will review progress with audit activity against the forward audit programme on a monthly basis and provide a quarterly summary to the Quality Governance Committee. • The Quality Governance Committee will receive a quarterly clinical audit report that will detail progress against audit activity highlighted within the forward audit programme and a summary of completed audit activity and associated recommendations and actions. • The Trust’s Audit Committee receives detail of any audit activity associated the assurance plan and risk register at each of its meetings. • The Trust Board will receive updates on progress of audit activity identified in the forward audit programme through the minutes and summary reports from both the Quality Governance Committee and the Audit Committee. • Quarterly ‘audit of audits’ will be conducted by the Clinical Audit Team Manager examining compliance with team processes and systems, with data fed back and discussed at clinical audit team meetings. • Methodologies used for sampling, collecting and analysing audit data are subject to team operating procedures ensuring robust, credible and accurate audit information being made available, from which recommendations/actions can be made with confidence. Proposals for all projects will be discussed at the CAPG considering methodologies and the scope proposed. This policy will be formally reviewed on a bi-annual basis and be updated before this date should national policy or local structures require.

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18

References National Institute for Health & Clinical Excellence, (NICE), “Principles for Best Practice in Clinical Audit”, 2002, Radcliffe Department of Health, “Working for Patients”, 2001 National Research Ethics Service, “Differentiating audit, service evaluation and research”, 2006 Data Protection Act, 1998 Clinical Audit: a simple guide for NHS Boards and partners 2010 http://good-governance.org.uk/clinical-audit-a-simple-guide-for-nhsboards-and-partner/

19

Glossary of Acronyms Used NICE SUI MHA PALS PD HIS MOC CAPG QGC SU

-

National Institute for Health and Clinical Excellence Serious Untoward Incident Mental Health Act Patient Advice and Liaison Service Performance Development (Team) Health Informatics Service Medicines Optimisation Committee Clinical Audit Project Group Quality Governance Committee Service User

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Project Code

Appendix One Clinical Audit Proposal Form

Title:

Audit Lead(s) / Designation Audit Lead Manager / Supervisor Contact Tel No. Project Steering Group: Directorate: Ideal Start Date: Estimated Finish: (up to action/plan)

Committee/Group responsible for approving and monitoring project Project Background / Rationale (a brief history to the project)

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What is the rationale for the project being undertaken – what are the ‘drivers’ Priority 1 National Patient Survey

NICE

CQC – Key Lines of Enquiry (SCREW)

CQUIN

Mental Health Act (MHA)

Risk / Risk Register

National Audit Priority 2 Assurance Framework

Serious Incident (SI) / Claims

Quality Accounts

Confidential Enquiry

PALS Concern / Complaint

RPIW

Other commissioning requirements / CCG/NHS England Priority 3 Other national initiative

Other external accreditation

Service evaluation

Regional audit project

Supporting service improvement

Patient involvement project

Health Inequalities (Equality& Diversity)

Patient feedback project

Priority 4 Individual interest

Local evaluation

Individual KSF requirements

Performance Mgt Issue

Re-Audit

Other (state)

Risk Details –

Is the project linked to the Risk Register

Yes 

No 

If Yes, Detailed on Risk Register

 (state which one)………………………………………………

SI

 (detail)……………………………………………………….…

Other

 (please state)……………………………………………….…

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Implications/impact Trust wide 

Division 

Directorate 

Service 

Team 

Aim / Objectives (purpose of the project e.g. improve, enhance, ensure, change, obtain together with activities to be undertaken)

Care Quality Commission – Essential Standards of Quality & Safety Indicate which if any of the following sections the audit project relates to. 1 2 3 4 5

‘Domain’ Safe Caring Responsive Effective Well-led

‘Detail’

Standards (e.g. NICE Guidelines, NHS LA, Policies, Protocols) (It is important that we are able to demonstrate how our services compare against any available national best practice and guidance. Please note support from library services is available if required) The necessary levels of compliance against standards are to be agreed and documented prior to the audit starting. These will be signed off by the monthly Clinical Audit Committee.

Method (How will you carry out the audit, who will be involved, what is the time frame, sample size etc.) Consider:  How audit tool is agreed  How data is to be collected and why method was chosen  Who is collecting the data  Sample chosen for the audit http://www.raosoft.com/samplesize.html  Time period over which data is collected  Which group/committee is responsible for monitoring project progress and approving actions …………………….. N.B Once data for a project has been collected the clinical audit team will normally feedback the initial results within 8 weeks. It will be the responsibility of the project clinical lead to write the summary/conclusion to the report putting the results into the context of services provided and also to develop recommendations and an action plan. The clinical audit project lead will also advise on the level of compliance awarded to the completed project, in line with clinical audit procedures. Audit results/report will be shared with relevant groups/committees such as Directorate Governance groups, and Trust wide Quality groups/committees. It will also be shared with the Clinical Audit Project Group to consider levels of compliance and make any necessary links to other quality initiatives. Once the initial data/report has been agreed an action will be placed on Performance Plus for the Project Lead to develop and agree an ‘Action / Plan’ (default timescale 8 weeks)

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Agreed actions will then be put onto Performance Plus and assigned to the person responsible for completion.

Timescales and Resources Task

Completed by: who

when

Clinical Audit Team support required (Y/N)

Planning / Agreeing method Devise and agree audit tool Pilot data collection Full data collection Analyse data Compile report Agree recommendations / Action Plan Present findings

Any other Clinical Audit Team support that may/will be required:

The project has been discussed and agreed by: Name

Date

Audit Lead: Audit Lead Manager / Supervisor: Dir. Governance Group: Clinical Audit Project Group Clinical Audit Team Lead/link:

Project Code:

When completed please return to the appropriate Audit Office: Clinical Audit Team Trust HQ (Mellor House) Corporation Street Stafford ST16 3SR

Clinical Audit Team Linden Suite The Redwoods Centre Shrewsbury SY3 8DS

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Appendix Two

Directorate Project Title Project Number Project Lead

Report compiled by Project Lead and Clinical Audit Team Date Initial results shared with project lead Summary and compliance indicator agreed with project lead Initial recommendations agreed with project lead Report to Local Governance Group Report to relevant TW committee(s) Report to Clinical Audit Project Group

(state)

Projects supports: CQC – Key Lines of Enquiry

Trust Headquarters, Corporation Street, Stafford, ST16 3SR Tel: (01785) 257888

Contents

Page Number Background Aim and Objectives References Methodology Results Conclusion / Summary Recommendations Action Plan Appendix

Background

Aim and Objectives

Standards and References

Methodology

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Results

Compliance Indicator Scope – Brief description of sample/scope of audit In line with Clinical Audit procedures this audit has been assigned a ‘Green’ level of compliance, based on agreed targets.

Green Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated …. Compliance Indicator

Scope – Brief description of sample/scope of audit In line with Clinical Audit procedures this audit has been assigned a ‘Green/Amber’ level of compliance, based on agreed targets.

Green/Amber Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated …. Compliance Indicator

Scope – Brief description of sample/scope of audit In line with Clinical Audit procedures this audit has been assigned an ‘Amber’ level of compliance, based on agreed targets.

Amber Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated …. Compliance Indicator

Scope – Brief description of sample/scope of audit In line with Clinical Audit procedures this audit has been assigned a ‘Red/Amber’ level of compliance, based on agreed targets.

Red/Amber Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated …. Compliance Indicator

Scope – Brief description of sample/scope of audit In line with Clinical Audit procedures this audit has been assigned a ‘Red’ level of compliance, based on agreed targets.

Red Brief explanation of why rating chosen: e.g. overall compliance very high one area low with risk associated …. Page 29 of 34

Conclusion / Summary

Produced by: Default – Project lead

Recommendations

Produced by: Default – Project lead

Links to Risk Is the audit linked to providing assurances to identified risks? Do the results identify any potential new risks to the organisation? Actions required:

Actions required

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Yes  No  Yes  No 

Action Plan Actions are to be agreed by the relevant trust wide group/committee and operational forum. The priority of the recommendations made is as follows: Priority

Description

High Medium

Recommendations are prioritised to reflect an assessment associated with levels of compliance and issues highlighted.

Low Suggestion

These are not formal recommendations that impact our overall opinion, but used to highlight a suggestion or idea that management may want to consider.

Recommendation

Priority

Accepted

Details of how the results of the audit are be shared / disseminated Include how results to be shared with participating teams Re-audit details

Any additional Governance Group / Committee comments:

Review Date ………………

Action Required / Management Comment

By Whom

By When

Appendix