clinical audit policy - east cheshire nhs trust audit... · policy title: clinical audit policy...

CLINICAL AUDIT POLICY

Policy Title:

Clinical Audit Policy

Executive Summary:

This document provides a framework for all clinical audit activity, from departmental duties and responsibilities, audit topic selection, implementation of action plans, reporting and outcomes achieved, within the East Cheshire NHS Trust.

Supersedes: V5

Description of Amendment(s):

Transfer existing policy document into the corporate policy template Inclusion of statutory requirements within introduction Updated definitions from NHS England and NICE Updated national audits section Updated KPIs Updated References Update of Appendix 2 – Terms of reference of CARE Group and update of Appendix 3 – Registration Form Appendix 5 – Clinical Audit Report

This policy will impact on: Trustwide systems relating to the consideration, dissemination, implementation and monitoring of clinical audits, including national clinical audits.

Financial Implications: Limited financial impact. Resources required in terms of policy author’s time to review their policies to ensure that they meet the standards outlined in this document.

Policy Area: Trust Wide Document Reference:

ECT002772

Version Number:

6.0 Effective Date: June 2017

Issued By: Director of Corporate

Affairs and Governance

Review Date: June 2019

Author: Integrated Governance

Manager

Impact Assessment Date:

June 2017

APPROVAL RECORD

Committees / Group Date

Consultation: Clinical, Audit, Research and Effectiveness (CARE) Group

12 June 2017

Approved by Director: Medical Director June 2017

Received for information:

Trustwide via Policy Cascade system

June 2017

Table of Contents

1. Introduction

4

2. Purpose

5

3. Roles and Responsibilities

6

4. Processes and Procedures

8

5. Monitoring Compliance with the Document

13

6. References

14

7. C Page 11

Page 12

Appendices

Appendix 1 Prioritising the Trust clinical audit programme

Appendix 2 Terms of Reference for the Clinical Audit, Research & Effectiveness

(CARE) Group

Appendix 3 Clinical Audit Registration Form

Appendix 4 Confidentiality Agreement

Appendix 5 Clinical Audit Report

1. Introduction

East Cheshire NHS Trust (the Trust) is committed to using clinical audit as a tool in strategic

management as part of the broader quality improvement programme. The Trust sees clinical audit as a cornerstone of its arrangements for developing and maintaining high quality patient-centred care. It is expected that this policy in cohesion with the Clinical Audit Strategy, aligns with the Trust’s wider governance and assurance mechanisms that will inform and enhance the process of improving clinical services.

“Participation in both national and local clinical audit is a statutory and contractual requirement for healthcare providers. The NHS standard contract forms the agreement between commissioners and providers of NHS-funded services, who must:

Participate in national clinical audits within the National Clinical Audit and Patient Outcomes Programme (NCAPOP) relevant to their services

Make national clinical audit data available to support publication of consultant-level activity and outcome statistics

Implement and/or respond to all relevant recommendations of any appropriate clinical audit

Implement an ongoing, proportionate programme of clinical audit of their services in accordance with good practice

Provide to the co-ordinating commissioner, on request, the findings of any audits carried out, in particular locally-agreed requirements such as Commissioning for Quality and Innovation (CQUIN) audits

In addition, the regulatory framework of the Care Quality Commission (CQC) requires registered healthcare providers to monitor the quality of their services. The CQC fundamental standards describe the care patients should expect, and provides prompts for providers to consider when aiming to meet requirements for governance and audit, set out in Regulation 17: Good governance, of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014,5 whereby:

“To meet this regulation, providers must have effective governance, including assurance and auditing systems or processes. These must assess, monitor and drive improvement in the quality and safety of the services provided, including the quality of the experience for people using the service. The systems and processes must also assess, monitor and mitigate any risks relating to the health, safety and welfare of people using services and others. Providers must continually evaluate and seek to improve their governance and auditing practice.” HQIP 2016

Providers must use the findings from clinical audits and other quality improvement initiatives, including those undertaken at a national level – such as national confidential enquiries and inquiries and national service reviews – to ensure that action is taken to protect people who use services. They must also ensure healthcare professionals are enabled to participate in clinical audit in order to satisfy the demands of their relevant professional bodies (for example, for revalidation and professional development).

5

2. Purpose

The purpose of this Clinical Audit Policy is to develop, maintain and support a culture of best

practice in the management and delivery of clinical audit within the Trust.

The Trust must use the findings from clinical and other audits, including those undertaken at a national level, and national service reviews to drive actions that will improve the quality of care delivered and, if any unsafe clinical practice is identified during audit, to ensure that a risk assessment is undertaken, and measures put in place and monitored effectively in order to deliver safe care. 2.1 Definition NHS England defines clinical audit as “a way to find out if healthcare is being provided in line with standards and lets care providers and patients know where their service is doing well, and where there could be improvements. The aim is to allow quality improvement to take place where it will be most helpful and will improve outcomes for patients. Clinical audits can look at care nationwide (national clinical audits) and local clinical audits can also be performed locally in trusts, hospitals or GP practices anywhere healthcare is provided.”

National Institute for Health and Clinical Excellence (NICE) defines clinical audit: “A systematic 'cycle'. It involves measuring care against specific criteria, taking action to improve it if necessary, and monitoring the process to sustain improvement. As the process continues, an even higher level of quality is achieved.”

2.2 Improvement and assurance East Cheshire NHS Trust supports the view that whilst clinical audit is fundamentally a quality

improvement process, it also plays an important role in providing assurances about the quality of

services.

2.2 Scope

Clinical audit underpins several quality improvement areas particularly:-

Clinical governance

Benchmarking

Quality indicators

Quality improvement

Staff development

Managing risk As a process, clinical audit can:

Provide evidence of current practice against national published guidelines or NHS quality standards.

Provide information about the structures and processes of a healthcare service and patient outcomes.

Assess how closely the local practice resembles the recommended practice.

Check that “we are actually doing what we think we are doing?”

http://www.hqip.org.uk/national-clinical-audits-managed-by-hqip/

http://www.hqip.org.uk/local-audit-support/

6

Provide evidence about the quality of care in our service to establish confidence amongst all of the service users and stakeholders – the staff, the patients and carers, the managers and the public.

3. Responsibilities

Chief Executive The Chief Executive is the Accountable Officer of the Trust and as such has overall accountability and responsibility for ensuring it meets its statutory and legal requirements and adheres to guidance issued by the Department of Health in respect of Clinical Governance. Medical Director The Medical Director has executive accountability for clinical effectiveness and is responsible for providing assurance to the Board on the implementation of this policy via the appropriate Board Committee. Director of Nursing, Performance and Quality The Director of Nursing, Performance and Quality is responsible for organisational operational management of clinical services and the delivery of the Quality Strategy. The Director has executive responsibility for ensuring the Trust provides high quality care, which is supported by the effective implementation of clinical audit within Directorates.

Director of Corporate Affairs and Governance

The Director of Corporate Affairs and Governance has accountability for governance and risk management across the Trust and for working in collaboration with the Medical Director to ensure the Board and relevant committees receive appropriate assurance with regard to the implementation of this policy. Associate Medical Director for Clinical Effectiveness The Associate Medical Director is the lead clinician accountable for the implementation of the Clinical Audit Policy across the Trust, providing clinical leadership across the organisation in respect of clinical audit. This responsibility extends to being the Chair of CARE Subcommittee and working closely with members of the group and identified audit leads to support quality improvements.

Deputy Director of Corporate Affairs and Governance The Deputy Director of Corporate Affairs and Governance will lead and ensure mechanisms are in place to manage the governance processes related to the Clinical Audit Policy in order to achieve best practice and continued improvement; this includes having accountability for the management of the Clinical Effectiveness Team. Head of Integrated Governance The Head of Integrated Governance will be responsible for the management and monitoring of compliance with clinical audit processes, policy and standards.

7

The Integrated Governance Manager The Integrated Governance Manager and is responsible for the management of the Clinical Effectiveness Team.

Clinical Effectiveness Team The Clinical Effectiveness Team is responsible for monitoring and reporting on the Trust clinical audit programme, ensuring that the requirement to provide assurance on compliance / implementation of national, regional and local standards of practice is met. This includes audit of the implementation of NICE guidance including quality standards and technology appraisals. The team members will work with representatives of the clinical service lines to prioritise audit activity which reflects the objectives of the organisation and provide support to ensure a programme of clinical audit and effectiveness activities is undertaken. The team will also review this policy for any changes in the external audit environment and update the policy as required in the timeframe specified.

Associate Directors Associate Directors are responsible for the local implementation of this policy within their respective areas and for ensuring that Clinical Audit Leads and clinical service line representatives on the Clinical Audit Research and Effectiveness Group fulfil their responsibilities for the delivery and monitoring of their clinical audit programme.

Clinical Audit Leads Clinical Specialty Audit Leads are responsible for promoting and monitoring clinical audit activity within their area of responsibility, ensuring that evidence of changes in practice, where required, is available.

Managers Managers are responsible for the local implementation of clinical audit and for ensuring staff adhere to the relevant clinical audit policy and procedures. All clinicians and healthcare professionals All clinicians and healthcare professionals are responsible for providing clinically effective care and treatment, which is supported through active participation in clinical audit and the implementation of improved practice as a result of learning.

8

4. Processes and Procedures

4.1 Involving patients and the public

The Trust promotes a commitment to the principle of involving patients/carers in the clinical audit

process either indirectly through the use of patient surveys/questionnaires or directly through the

participation of identified individuals on project steering groups, or patient forums.

4.2 Multi-disciplinary and multi-professional audit, and partnership working with other

organisations

The Trust encourages clinical audit undertaken jointly across professions and across

organisational boundaries. Partnership working with other local and regional organisations will be

encouraged where improvements to the patient journey may be identified through shared clinical

audit activity.

4.3 Working with commissioners

For East Cheshire NHS Trust, as a provider organisation, clinical audit activity should reflect

commissioners’ requirements and aspirations, for example, by providing evidence for

commissioning with regards to contractual requirements. The findings of any audit must be made

available to the Commissioner on request and the Commissioner can appoint an auditor to audit

quality and outcomes and the recording and coding of clinical activity

4.4 Agreeing an annual programme of activity

On an annual basis, the Trust will agree an appropriate planned programme of clinical audit

activity. This will meet its corporate requirements for assurance, whilst reflecting and

supporting the Trust Board objectives, however it will be ‘owned’ by the clinical services.

To facilitate this, each directorate Clinical Audit Lead, in consultation with colleagues, will use

the “Prioritising the Trust Clinical Audit Programme” (appendix 1) to inform the development of

its annual audit programme.

This process enables the consideration of both ‘bottom up’ (via clinical staff/services, patients,

etc) and ‘top down’ (via Trust Board, committees, directorates or external/commissioner

requirements) and the prioritisation of “must do” audits.

Exceptions will be as outlined under ‘ad hoc audits’ where it can be clearly demonstrated that

an audit which was not included in the annual planner merits inclusion and prioritisation.

Once approved by the directorate’s Safety Quality and Standards Committee as being robust, and supporting its assurance programme, the audit plan will be forwarded to the Clinical Audit Research and Effectiveness Group for ratification, and inclusion in the Trust’s annual clinical audit programme.

4.5 Choosing and prioritising clinical audit topics

There are many reasons why clinical audits are undertaken, although in essence there are two

main drivers: quality improvement and quality assurance. As clarified in 4.4 above, “Prioritising the

9

Trust Clinical Audit Programme” (appendix 1) will be used to inform the selection of local clinical

audit topics.

4.6 National audits

“The National Clinical Audit and Patient Outcomes Programme (NCAPOP) audits are

commissioned and managed on behalf of NHS England by the Healthcare Quality Improvement

Partnership (HQIP). The programme comprises more than 30 national audits related to some of

the most commonly-occurring conditions. These collect and analyse data supplied by local

clinicians to provide a national picture of care standards for that specific condition. On a local level,

NCAPOP audits provide local trusts with individual benchmarked reports on their compliance and

performance, feeding back comparative findings to help participants identify necessary

improvements for patients. Most of these projects involve services in England and Wales; some

also include services from Scotland and Northern Ireland.” NHS England 2017

4.7 Monitoring the Trust’s annual clinical audit programme

To facilitate the monitoring of audits listed on the Trust’s annual clinical audit programme, an audit

database is maintained by the Clinical Effectiveness Team, identifying all audits undertaken and

their progress, which will support assurance of completion of the audit cycle, and identify any risks

along with changes in practice, if appropriate.

The Clinical Effectiveness Team monitor the completion of audit action plans, to support the achievement of those action plans within the agreed timescales.

To support ownership of the programme by the directorates and where appropriate add identified

risks to the risk register, the audit programme will be discussed on a regular basis by the

directorate SQS Committees. Remedial action will be taken, when, and if, non-listed audits are

being registered/undertaken as priority over the audits that are specified on the audit programme.

On a monthly basis the Clinical Audit, Research and Effectiveness Subcommittee will appraise

clinical audit activity across the Trust, highlighting any areas of concern to the appropriate

directorate/speciality Clinical Audit Lead, and requesting action through the directorate SQS

Committees.

4.8 Systems for registering and approving audits

All clinical audit activity must be registered with the Clinical Effectiveness Department before it can

proceed.

The clinical audit planning/registration form (appendix 3) must be signed by the person undertaking

the audit and also countersigned approval must be provided by their consultant / clinical manager.

4.9 The use of standards (or criteria) in clinical audit

Clinical audit involves measuring clinical practice against predetermined standards of best practice (see Appendix 1: prioritising the trust clinical audit programme) therefore only those audits which

http://www.hqip.org.uk/

http://www.hqip.org.uk/

10

reference the guidance/standard against which the audit is being undertaken, may be registered as a clinical audit.

4.10 Equality and diversity

All staff undertaking clinical audits within the Trust must take account of equality and diversity

issues, ensuring that the process for determining choice of clinical audit projects and the manner in

which audit patient samples are drawn up, does not inadvertently discriminate against any groups

in society based on these protected characteristics:

Age

o Where this is referred to, it refers to a person belonging to a particular age (e.g. 32

year olds) or range of ages (e.g. 18 - 30 year olds).

Disability

o A person has a disability if s/he has a physical or mental impairment which has a

substantial and long-term adverse effect on that person's ability to carry out normal

day-to-day activities.

Gender reassignment

o The process of transitioning from one gender to another.

Marriage and civil partnership

o In England and Wales marriage is no longer restricted to a union between a man

and a woman but now includes a marriage between a same-sex couple. [1] This will

also be true in Scotland when the relevant legislation is brought into force. [2]

o Same-sex couples can also have their relationships legally recognised as 'civil

partnerships'. Civil partners must not be treated less favourably than married

couples (except where permitted by the Equality Act).

Pregnancy and maternity

o In the non-work context, protection against maternity discrimination is for 26 weeks

after giving birth, and this includes treating a woman unfavourably because she is

breastfeeding.

Race

o Refers to a group of people defined by their race, colour, and nationality (including

citizenship) ethnic or national origins.

Religion and belief

o Religion has the meaning usually given to it but belief includes religious and

philosophical beliefs including lack of belief (e.g. Atheism). Generally, a belief

should affect your life choices or the way you live for it to be included in the

definition.

Gender

Sexual orientation.

Whilst undertaking clinical audit, staff should aim to be wholly inclusive and not exclude those with

protected characteristics.

11

4.11 Reports and Action plans

4.11.1 Action plans

Details of completed audits will be presented at specialty audit meetings where the findings will be

reviewed, risks identified and discussed. Action plans will then be developed within the directorate

with a commitment to re-audit made if required. Action plans should be specific, measurable and

achievable/realistic. They should have clear implementation timescales with identified leads for

each action. Action plans should be approved by the relevant Clinical Audit Lead and included in

the Audit Report. In the case of clinical risks having been identified then these should be escalated

to the Clinical Director and Associate Director in order for the associated action plans to be

managed by the directorate SQS.

Not all clinical audits will require an action plan e.g. where an audit shows that standards are being

met or guidance followed. For such audits there should be an explicit statement saying ‘no further

action required’ in the audit report and a reason given for no re-audit.

4.11.2 Re-audit

Re-audit is necessary to determine whether agreed actions have been implemented according to

the action plan, where audits have demonstrated a need for change in practice it is expected that a

timescale for implementation of the actions will include a planned re-audit and findings of the re-

audit will be submitted to the specialty audit meeting and to CARE Subcommittee. This provides

assurance that the audit cycle has been completed.

4.11.3 Reports

Once data has been collected, analysed and an agreement reached as to any actions required, it

is the responsibility of the clinician undertaking the audit to populate the clinical audit report

template (see appendix 5) and when fully completed, forward to Clinical Effectiveness Department

for uploading to the clinical audit folder on the Trust’s shared drive.

Any clinical audit reports that are received with missing information (e.g. author, action plan not

completed) will be returned to the auditor for completion and return. This will ensure that all

evidence required to inform changes in practice, or re-audit meets the Trust requirements and will

be retained to enable the audit cycle to be completed by another clinician, particularly relevant in

the case of medical staff on rotation.

4.12. Dissemination and Celebrating Success

4.12.1 Dissemination

Details of completed audits will be presented at specialty audit meetings where the findings will be

discussed, action plans will then be agreed by the Clinical Audit Lead in conjunction with the

relevant Service Manager / directorate SQS and a commitment to re-audit made if required.

A rolling programme has been established, whereby specialties will be invited to attend and

present clinical audits at the quarterly Audit CARE Subcommittee meetings. These audit

presentations will enable knowledge sharing across the service lines and the opportunity for

discussion and feedback on the audit results.

Regular summary clinical audit reports, together with recommendations will be included within the

papers for the monthly CARE Group.

12

The underpinning objective throughout the process is a focus on the final outcomes of clinical

audit, sharing information on the successes of patient experience and patient safety improvement,

and it is this focus that should be highlighted following the completion and dissemination of the

successful audit.

4.12.2 Clinical Audit Certificate

All health professionals who are participants in completed clinical audits that have been registered

with the Clinical Effectiveness Department will receive a certificate of participation. The certificate

can be used to demonstrate clinical audit activity when required for external assessment,

accreditation or revalidation. It is also relevant to individuals’ KSF.

4.12.3 Quality Accounts

On an annual basis the Clinical Effectiveness Department submit an entry into the Trust’s Quality Accounts publication. This acknowledges participation in national audits/quality accounts and provides examples of best practice audits that have been presented at the clinical audit meetings. The Quality Account focuses on clinical audit outcomes and the implementation of action plans to evidence improvements in patient care.

4.13 Information governance: collection, storage and retention of data and confidentiality

All clinical audit activity must also take into account the Data Protection Act (1998) and the

Caldicott Principles (1997) along with The Caldicott Report – A review of Information Governance

2013. This means that data should be:

adequate, relevant and not excessive

accurate

processed for limited purposes

held securely

not kept for longer than is necessary whilst taking into account the Department of Health

publication Records Management: NHS Code of Practice (2009) which requires “audit records”

be retained for a period of five years, (no definition of the term “record” in this context is

provided ).

Clinical audit activity must also conform to the requirements of the NHS Confidentiality Code of

Practice (2003)21 which states that:

“Patients must be made aware that the information they give may be recorded, may be

shared in order to provide them with care, and may be used to support local clinical audit”

If patients have been so informed, Section 60 of the Health and Social Care Act 2001 makes

provision for the collection of patient identifiable data for the purposes of clinical audit; however

best practice requires that all data is anonymised unless there is a compelling reason not to do so.

13

4.14 Confidentiality agreements

Any individual who is not directly employed by East Cheshire NHS Trust but is engaged by the

organisation to take part in audit activities (e.g. staff on honorary contracts, volunteers etc.), will be

required to sign a Confidentiality Agreement (see appendix 4).

4.15 Ethics and consent

By definition, clinical audit projects should not require formal approval from a Research Ethics

Committee. However, one of the primary principles underpinning clinical audit is that the process

should aim to improve quality. Clinical audit must always be conducted within an ethical

framework:

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.

5. Monitoring Compliance with the Document

5.1 Monitoring the effectiveness of clinical audit activity

The Clinical Effectiveness Department monitor the compliance with the above, including the undertaking of action plans and re-audits by the directorates, through the use of the clinical audit scorecards created at the point of audit registration.

Directorates will likewise undertake the process as described in section 4.7 above.

5.2 Measuring Performance Compliance with this policy will be monitored against the following key performance indicators:

a) The final Trust Annual Audit Plan is agreed by the directorate SQS Committees and CARE Subcommittee

b) All NCAPOP audits that are relevant to the services provided by the Trust are completed and data is included within the Quality Accounts

c) All audits are registered on the clinical audit registration form, must be signed by the person undertaking the audit and also countersigned approval must be provided by their consultant / clinical manager

d) All audits are monitored via the audit database and on the directorate scorecard and have completed action plans where relevant

The Head of Integrated Governance will audit the above twice a year and report performance to the CARE group.

14

5.3 Audit This policy will be audited in line with the systems defined by the Clinical Effectiveness Department and reported to the CARE Subcommittee as specified. Any action plans developed from this audit will be agreed by the CARE Subcommittee with a monthly review of progress.

5.4 Review This policy will be reviewed on a three yearly basis by the Integrated Governance Manager

5.5 Retention of audit records

It is a fundamental requirement that all of the Trust’s records are retained for the correct period of time prior to secure destruction. In terms of clinical Audits, records need to be retained for 5 years after completion of the audits. Other audits such as organisational audits, record audits, systems audits need to be retained for 2 years after completion.

6.0 References

1. HQIP : Developing a clinical audit policy (November 2016) 2. NHS England 2017: https://www.england.nhs.uk/ourwork/qual-clin-lead/clinaudit 3. NICE 2017: https://www.nice.org.uk/Glossary 4. HQIP : Statutory and mandatory requirements for clinical audit (2016)

https://www.england.nhs.uk/ourwork/qual-clin-lead/clinaudit

https://www.nice.org.uk/Glossary

15

Appendix 1 - PRIORITISING THE TRUST CLINICAL AUDIT PROGRAMME Clinical audit programmes should include national and local clinically led projects. National initiatives should be balanced with local priorities or concerns1. Key Trust Audits NICE Guidance NCEPOD/ National Service Frameworks/ National Strategies National / Regional Audits Quality Accounts Royal College Guidelines Selected clinical indicators Reflect Clinical Governance issues identified from complaints, risk management, litigation etc Reflect issues from Trust Development / business plan CQC Assurance & Compliance Re-audits Quality Assurance Audits NPSA Alerts Audits identified as required, in action plans following Trust External and Internal Audits Key Trust audits reflect national, regional and Trust Board objectives prioritising and including those which the Trust is required to undertake by official bodies, including the Department of Health, Care Quality Commission, GP Commissioners etc. These include NCEPOD, the national audits listed in Quality Accounts and those providing assurance of compliance with NICE guidance. From the national audits valuable comparative benchmarking data is obtained which informs service development, whilst other initiatives, such as re audits, provide assurance that actions undertaken as a result of previous audits, are robust and sustainable. Key Local Audits Essence of Care Local policies Identified local issues Directorates will indicate the priority local audits they wish to undertake ensuring they support the Trust Board objectives in providing “high quality integrated services”. These audits will be monitored via the audit scorecards (see 4.7) which are reviewed at CARE Subcommittee meetings, although the priority remains with undertaking those identified in the key trust audit listing. Ad-hoc

Audits additional to the agreed programme but in response to educational needs and /or

unexpected issues of importance

16

Appendix 2 – Clinical Audit, Research & Effectiveness (CARE) Group –

Terms of Reference

Title: Clinical Audit, Research & Effectiveness (CARE) Group - Terms of Reference

East Cheshire NHS Trust

Authors Names: Director of Corporate Affairs and Governance Associate Medical Director for Clinical Effectiveness

Scope: Trust Wide Classification: Trust Organisation Structure and Minutes

Replaces: v6

To be read in conjunction with the following documents: -

Unique Identifier: TOR v7

Review Date: August 2017 This document is no longer authorised for use after this date

Issue Status: Approved Issue No: Issue Date: August 2016

Approved by: Clinical Audit, Research & Effectiveness Group

Date: 01/08/2016

Document for Public Display: Yes

After this document is withdrawn from use it must be kept in an archive for 6 years.

Archive: Date added to Archive:

Officer responsible for archive: Chair of Clinical Audit, Research & Effectiveness Group

17

1. Definition

The Clinical Audit, Research and Effectiveness (CARE) Group is established as a sub-group of the East Cheshire NHS Trust Safety, Quality and Standards (SQS) Committee.

2. Membership

Associate Medical Director of Clinical Effectiveness (Chair)

Director of Corporate Affairs & Governance (Deputy Chair) to attend developmental meetings only

Deputy Medical Director, Trust lead for Research or representative

Head of Integrated Governance

Integrated Governance Manager

Clinical Effectiveness, Research & Development representative

Deputy Chief Pharmacist or representative

NCEPOD Ambassador/Reporter

MBRACCE Ambassador/Reporter

At least one nominated representative from each Service Line (where nominated representative unable to attend a deputy should attend on their behalf)

In addition co-opted input from Finance/Service Improvement will be sought as required

A record of attendance will be maintained by the Chair of the Committee.

Members of the Committee must attend 75% of the meetings across each financial year.

The Chair of the Committee will review the attendance six monthly and report to the Committee to agree actions required where attendance has not met minimum requirement.

All members will be expected to contribute at the meetings, share information/ actions required and bring views of their colleagues to the meeting where appropriate.

3. Quorum

The chair plus 4 members of the group may meet to transact business and those proceedings shall be recorded as a meeting of the group.

To be quorate, at least three attendees should be nominated representatives of clinical services.

4. Frequency of Meetings

The Group will meet monthly, or more frequently, if required 5. General Responsibilities and Purpose

Overview

To provide a clear framework through which we will ensure the delivery of excellence in clinical care across the Trust, by a programme of monitoring and evaluation (see below)

18

To work with, and through the Service Lines to ensure compliance with the Care Quality Commission Standards and the Quality Accounts, relating to clinical audit, and clinical effectiveness:-

- National Institute for Health and Care Excellence (NICE) Guidance - National plans e.g. National Clinical Audit & Patient Outcomes Programme

(NCAPOP) - National Confidential Enquiry into Patient Outcome & Death (NCEPOD) - Mothers & Babies Reducing Risk through Audit & Confidential Enquiries

across the UK (MBRRACE)

To ensure compliance with Department of Health standards in relation to research:-

Research Governance Framework and other relevant legislation.

To review and update existing policies and/ or strategies for Clinical Audit / Effectiveness and for Research. To provide guidance for their implementation, and monitor the achievement of objectives.

To ensure that any barriers to the implementation of recommended actions required by National Organisations cited within this document, or in relation to audits where changes in practice are required, are highlighted and addressed, escalating any unresolved issues to the Service Lines SQS Committees, and ultimately to the Trust SQS Committee.

Clinical Audit

To ensure that the Trust’s audit programme meets the organisation's aims and objectives as part of the wider quality improvement agenda.

Evidence of re-audit cycle for those areas requiring improvement.

To monitor the progress being made in implementing the recommendations from national clinical audits. In order to achieve this the Service Lines will be asked to provide evidence of compliance with the recommendations through data acquired through their audit programme.

To provide service areas with an outline of a structure to provide assurance on clinical audit activity.

National Clinical Guidance

To monitor the NICE guidance implementation process, and provide assurance for the commissioners. The Service Lines will be asked to submit data from their audit programme in order to provide evidence of such implementation. This information will be collated onto the Trust’s scorecards, and database, and fed back as necessary.

To monitor evidence of achievement of the National Service Framework targets, and compliance with recommendations produced in the NCEPOD and MBRRACE reports. In order to achieve this, the Business Groups will be required to produce regular updates demonstrating the current position with respect to targets / recommendations with supporting action plans.

19

Research

To facilitate, and oversee, the application of principles of research governance as required by the Framework for Research Governance.

To promote an active research culture within the Trust, and encourage those processes which aid wider participation in high quality research.

6. Conduct of Meetings

The following will be co-opted to attend, or submit a report, as required by the group:

Audit leads will be required to submit their audit programmes thus enabling the CARE group to monitor whether or not these support the wider Trust Audit Programme. They will be asked to demonstrate that audits undertaken have led to changes in practice, and, where not, what the risk is to the organisation. Where audits have demonstrated a need for change in practice a re-audit will be required and this will be identified as part of the audit report.

The named leads for actioning NCEPOD, MBRRACE and national audit reports

will be required to submit evidence of compliance / action plans together with an estimation of risk to the organization associated with non- or partial compliance. This will deliver assurance to the Trust that the guidance is met, or that any failures to fully comply, are being addressed.

Those researchers, and clinical areas which are involved in Portfolio studies,

and are receiving a funding allocation from the Clinical Local Research Network, will be required to submit an annual report clarifying details of expenditure, and other additional areas e.g. accrual data, as specified by the CLRN, in its agreement with the Trust.

Quarterly the meeting will be a CARE/Audit meeting where the audit leads will

attend to review progress against the audit plan and also present audits from their service lines.

Quarterly the meeting will be a CARE/Research meeting where representatives

from the research teams will attend to provide an update on the research programme

7. Annual Review of the Committee

The Committee will undertake an annual self-assessment on their effectiveness and performance to:-

- Review its own performance to ensure it is operating effectively; - Determine whether it’s planned activities and responsibilities for the previous

year have been sufficiently discharged; and - Recommend any changes and / or actions it considers necessary, in respect

of the above

An annual written report will be provided to the Trust Board Safety, Quality & Standards Committee, which details the Self-Assessment as an appendix

20

8. Monitoring Compliance

As part of the annual self-assessment referred to in Paragraph 8, which will be reported in the annual report, the Committee will review that the terms of reference have been complied with and whether they remain fit for purpose.

Duties Reporting arrangements to the Trust Board Safety, Quality & Standards

Committee Membership, including nominated deputy where appropriate Required frequency of attendance by members Requirements for a quorum Frequency of meetings Process for monitoring compliance with all of the above

9. Terms of Reference

These will be reviewed in August 2017 (annually) or as required.

21

Appendix 3 – Clinical Audit Registration Form

CLINICAL AUDIT AND QUALITY IMPROVEMENT PLANNING/ REGISTRATION FORM PLEASE COMPLETE ALL PARTS TO ENSURE TRUST STANDARDS ARE MET

Return to Clinical Effectiveness, Top Floor, New Alderley Building, Macclesfield SK10 3BL Tel: 01625 661966/3678/1871

Email: [email protected]

Your details: Project Ref. No. (CE use only)

Name: Click here to enter text. Directorate: Choose an item.

Position/Job Title: Click here to enter text. Department: Click here to enter text.

Contact/Bleep No./Email Address: Click here to enter text.

Resource Implications:

Have the resources to undertake this audit been considered and approved? Yes-☐ No-☐

Title of audit/ QIP:

Click here to enter text.

Aims and Objectives of the Audit/ QIP: Aim: Briefly describe the reasons for undertaking the audit – what do you want to achieve? e.g. "Are we following the appropriate guidelines for management of patients with pressure sores?" Objective(s): Breaking the overall purpose down into smaller steps that need to be achieved to address the aim: e.g. To ensure timely assessment and treatment of pressure sores.

Click here to enter text.

Timescales of the Audit/ QIP:

Registration Date: Click here to enter a date. Start date: Click here to enter a date.

Completion Date: Click here to enter a date. Presentation date: Click here to enter a date.

NB: To complete the Trust audit cycle and acquire a certificate, an audit report and action plan is required to be submitted to Clinical Effectiveness no more than 4 weeks following presentation of findings.

Are you leaving the Trust in the near future?

Yes-☐ No-☐

If yes, please give leaving date*:

Click here to enter a date.

*If your project will not be finished by this date please identify and provide the name, job title and contact number

of another member of staff who will take over when you leave.

Audit responsibility: Click here to enter text.

Priority for audit/ QIP: Please tick as many as appropriate and provide details.

Quality Accounts/ national/ regional audit Title: Click here to enter text. ☐

NICE Guidance No: Click here to enter text. Title: Click here to enter text. ☐

CQC Assurance & Compliance ☐

mailto:[email protected]

22

Royal College Guidelines/National Guidelines ☐

Re-audits ☐

Quality Assurance Audits/ Service Developments ☐

NPSA Alerts No: Click here to enter text. Title:Click here to enter text. ☐

Local issues/ other: Click here to enter text. ☐

Trust Board Strategic Objectives Please tick as many as appropriate

Medical Records If you require assistance with pulling records please complete the following.

Anticipated no. of records required for audit: Click here to enter text.

Records to be tracked to: Click here to enter text.

Records to be delivered to: Click here to enter text.

(You must advise appropriate staff (e.g. secretaries) about this audit, as well as arranging responsibility for casenotes during the period of this audit before tracking and returning to the library.) Please note that if you require records for deceased patients these may have to be recalled from EDM or Deepstore - this will require approximately 2 weeks’ notice and will have a cost implication for your department.

Equality & Diversity All staff undertaking clinical audits within the Trust must take account of equality and diversity issues through ensuring that the process for determining choice of clinical audit projects, and the manner in which project patient samples are drawn up, does not inadvertently discriminate against any groups in society, based on their race, disability, gender, age, sexual orientation, religion and belief.

Have you considered the above in your audit planning? Yes-☐ No-☐

Are there any equality and diversity issues present in your audit? Yes-☐ No-☐

Project Lead: I understand that non-anonymised (staff/patient) audit data must not be taken outside the Trust and the transfer of any data must meet all relevant Trust policies and procedures (see Trust Intranet). I understand that the results belong to the Trust, not myself, and agree to the results appearing in the Trust's Clinical Audit reports. I confirm that the information provided is accurate to the best of my knowledge. By signing this form I agree to ensure that this project is completed, the results disseminated, and a report and action plan given to my clinical audit facilitator. Signature of Project Lead …………………...…….… Name:

Date: Click here to enter a date.

Senior Clinician/Manager: I confirm that the full implications of this project, including priority of the topic within the Directorate and resource implications, have been considered. I also agree to ensure the dissemination of audit results and lead on the implementation of an action plan (as appropriate), in order to obtain improvements in the quality of care provided.

Signature of Senior Clinician/Manager: ……………...…… … Name: Click here to enter text.

All audits undertaken need to support the Trust board objectives in providing “high quality integrated

services”.

1. Provide safe, effective personal care in the right place ☐

2. Build, value and develop a motivated and sustainable workforce. ☐

3. Work within the Caring Together framework to deliver our vision. ☐

4. To deliver services that are clinically and financially sustainable. ☐

23

Health and Safety Process Flow Chart Appendix 4 – Confidentiality Agreement

Confidentiality Agreement

This declaration must be signed by any person who is not employed by East Cheshire NHS Trust,

or deemed an honorary employee through association with the appropriate department of the

[academic body], who will be reviewing patient-related information for the purposes of clinical audit.

Declaration

I hereby declare that I fully understand that all patient-related information to which I have access,

whether held on computer or in written form or given to me verbally, is confidential and I undertake

never to divulge information to anyone without the authority of a senior member of administrative

staff. I understand that this includes the divulging of information to the police.

I also understand that the names, addresses and details of patients contained in any documents or

indexes are confidential and must not be accessed or divulged for personal interest or gain, or any

other purpose other than healthcare business.

By signing this form I accept that I have been informed that under the provisions of the Data

Protection Act 1998, unauthorised disclosure of data may result in personal prosecution.

Name

Project title:

Post:

Department:

Email address:

Mobile/telephone no:

Signature and date:

Witnessed by and date:

1

Appendix 5 – Clinical Audit Report

Clinical Audit Report

Directorate:

Specialty:

Title:

Audit Number:

Date:

When & to Whom Presented:

Auditors:

Please embed the Presentation here: All reports must include an action plan, which is to be found at the end of this report. It should include the action required, who has responsibility for doing it and the date by which it should be completed, and if necessary, date and plan for re-audit. Please also highlight any risk(s) identified from the findings of this audit. No actions required should also be indicated. The action plan should be formed in conjunction with the supervising consultant and agreed, and signed off by the relevant Service Line Audit group, Clinical Director (or Clinical Lead) and Associate Director (or Deputy).

Please indicate if the Presentation includes:

1. Executive Summary Yes No (This should contain an overview of the message in the report, with a clear summary of the recommendations) 2. Introduction/Background Yes No (These can be two separate sections or combined. It should set the context of the report and define the scope and any limitations of the audit.)

3 Aims and Objectives Yes No (This should clearly identify what you want to achieve.)

4 Standards Yes No (This section documents the standards against which the current practice is measured. It should include the relevant evidence base from which the standards are taken) 6 Results Yes No (This is the main body of the report from which the author’s ideas are developed. It should include the main findings in a logical and progressive manner interspersed with graphs to assist as necessary.) 7. Conclusions Yes No (These are derived from the results section and should also link back to the aims and objectives. No new information should be included. Bullet points are a recommended way for emphasizing the key points.)

8. Recommendations Yes No (This section highlights the actions which need to be taken to follow on from the audit. As with the conclusion section, recommendations should be derived from the main body of the report and should not include new information.)

If the answer to any of the above is NO, please add a short summary in this Report

9 References

(All items referred to in a report should be appropriately referenced)

Action Plan following Audit

No. Audit Recommendation

(What needs to change)

Action Required

(What is going to be done)

Outcome Expected (How will

we know the change has taken place)

Evidence

(How will we demonstrate this)

Responsible person(s)

Action requires service line/ organisation

consideration

Completion Date

1

2

3

4

5

Report Author Signature………………………… …………..……………………….

Senior Authorising Clinician Signature ……………… ……………………………….…….…

Actual Audit Outcome

Equality Analysis (Impact assessment)

1. What is being assessed?

Clinical Audit Policy

Details of person responsible for completing the assessment:

Name: Pam Laird

Position: Integrated Governance Manager

Team/service: Clinical Effectiveness Department

State main purpose or aim of the policy, procedure, proposal, strategy or service:

(usually the first paragraph of what you are writing. Also include details of legislation, guidance,

regulations etc which have shaped or informed the document)

The purpose of this Clinical Audit Policy is to develop, maintain and support a culture of best practice and quality

improvement in the management and delivery of clinical audit within the Trust.

2. Consideration of Data and Research

To carry out the equality analysis you will need to consider information about the people who use the

service and the staff that provide it.

2.1 Give details of RELEVANT information available that gives you an understanding of who will be

affected by this document

Cheshire East (CE) covers East Cheshire CCG. Cheshire West & Chester (CWAC) covers Vale Royal. In 2011,

370,100 people resided in CE and 329,608 people resided in CWAC.

Age: East Cheshire and South Cheshire CCG’s serve a predominantly older population than the national

average, with 19.3% aged over 65 (71,400 people) and 2.6% aged over 85 (9,700 people).

Vale Royal CCGs registered population in general has a younger age profile compared to the CWAC average,

with 14% aged over 65 (14,561 people) and 2% aged over 85 (2,111 people).

Since the 2001 census the number of over 65s has increased by 26% compared with 20% nationally. The

number of over 85s has increased by 35% compared with 24% nationally.

Race:

In 2011, 93.6% of CE residents, and 94.7% of CWAC residents were White British

5.1% of CE residents, and 4.9% of CWAC residents were born outside the UK – Poland and India being the most common

3% of CE households have members for whom English is not the main language (11,103 people) and 1.2% of CWAC households have no people for whom English is their main language.

Gypsies & travellers – estimated 18,600 in England in 2011.

Gender: In 2011, c. 49% of the population in both CE and CWAC were male and 51% female. For CE, the

assumption from national figures is that 20 per 100,000 are likely to be transgender and for CWAC 1,500

transgender people will be living in the CWAC area.

Disability:

In 2011, 7.9% of the population in CE and 8.7% in CWAC had a long term health problem or disability

In CE, there are c.4500 people aged 65+ with dementia, and c.1430 aged 65+ with dementia in CWAC. 1 in 20 people over 65 has a form of dementia

Over 10 million (c. 1 in 6) people in the UK have a degree of hearing impairment or deafness.

C. 2 million people in the UK have visual impairment, of these around 365,000 are registered as blind or partially sighted.

In CE, it is estimated that around 7000 people have learning disabilities and 6500 people in CWAC.

Mental health – 1 in 4 will have mental health problems at some time in their lives.

Sexual Orientation:

CE - In 2011, the lesbian, gay, bisexual and transgender (LGBT) population in CE was estimated at18,700, based on assumptions that 5-7% of the population are likely to be lesbian, gay or bisexual and 20 per 100,000 are likely to be transgender (The Lesbian & Gay Foundation).

CWAC - In 2011, the LGBT population in CWAC is unknown, but in 2010 there were c. 20,000 LGB people in the area and as many as 1,500 transgender people residing in CWAC.

Religion/Belief:

The proportion of CE people classing themselves as Christian has fallen from 80.3% in 2001 to 68.9% In

2011 and in CWAC a similar picture from 80.7% to 70.1%, the proportion saying they had no religion

doubled in both areas from around 11%-22%.

Christian: 68.9% of Cheshire East and 70.1% of Cheshire West & Chester

Sikh: 0.07% of Cheshire East and 0.1% of Cheshire West & Chester

Buddhist: 0.24% of Cheshire East and 0.2% of Cheshire West & Chester

Hindu: 0.36% of Cheshire East and 0.2% of Cheshire West & Chester

Jewish: 0.16% of Cheshire East and 0.1% of Cheshire West & Chester

Muslim: 0.66% of Cheshire East and 0.5% of Cheshire West & Chester

Other: 0.29% of Cheshire East and 0.3% of Cheshire West & Chester

None: 22.69%of Cheshire East and 22.0% of Cheshire West & Chester

Not stated: 6.66% of Cheshire East and 6.5% of Cheshire West & Chester

Carers: In 2011, nearly 11% (40,000) of the population in CE are unpaid carers and just over 11% (37,000)

of the population in CWAC.

2.2 Evidence of complaints on grounds of discrimination: (Are there any complaints or concerns raised

either from patients or staff (grievance) relating to the policy, procedure, proposal, strategy or service or

its effects on different groups?)

None to my knowledge.

2.3 Does the information gathered from 2.1 – 2.3 indicate any negative impact as a result of this document?

None to my knowledge.

3. Assessment of Impact

Now that you have looked at the purpose, etc. of the policy, procedure, proposal, strategy or service (part

1) and looked at the data and research you have (part 2), this section asks you to assess the impact of the

policy, procedure, proposal, strategy or service on each of the strands listed below.

RACE: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the

potential to affect, racial groups differently? Yes No

Explain your response:


protected characteristics

____________________________________________________________________________________

GENDER (INCLUDING TRANSGENDER):

From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the

potential to affect, different gender groups differently? Yes No




DISABILITY From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the

potential to affect, disabled people differently? Yes No



protected characteristics.

______________________________________________________________________________ AGE:

From the evidence available does the policy, procedure, proposal, strategy or service, affect, or have the

potential to affect, age groups differently? Yes No




LESBIAN, GAY, BISEXUAL:


potential to affect, lesbian, gay or bisexual groups differently? Yes No



protected characteristics -

_____________________________________________________________________________________

RELIGION/BELIEF: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the

potential to affect, religious belief groups differently? Yes No




_____________________________________________________________________________________

CARERS:


potential to affect, carers differently? Yes No




_____________________________________________________________________________________

OTHER: EG Pregnant women, people in civil partnerships, human rights issues. From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the

potential to affect any other groups differently? Yes No



protected characteristics -

____________________________________________________________________________________

4. Safeguarding Assessment - CHILDREN

a. Is there a direct or indirect impact upon children? Yes No

b. If yes please describe the nature and level of the impact (consideration to be given to all children;

children in a specific group or area, or individual children. As well as consideration of impact now or in

the future; competing / conflicting impact between different groups of children and young people:

Paediatric audits are carried out at the Trust and are categorised into various areas e.g. NICE Guidance, NPSA Alerts,

National audits, NHSLA, Royal College and local issues. The sample identification is individual to each audit and needs

to be representative. In some cases e.g. National audits - the sample required is identified, however for other audits

the auditor is responsible for identifying the sample required in terms of size, dates etc. Although this sample may be

amended if the dates given do not show any cases that are required for the specific audit.

c. If no please describe why there is considered to be no impact / significant impact on children

5. Relevant consultation

Having identified key groups, how have you consulted with them to find out their views and that the made

sure that the policy, procedure, proposal, strategy or service will affect them in the way that you intend?

Have you spoken to staff groups, charities, national organisations etc?

CARE (Clinical Audit and Research Effectiveness) Subcommittee have been consulted for amendments.

6. Date completed: 14/06/2017 Review Date: June 19

7. Any actions identified: Have you identified any work which you will need to do in the future to

ensure that the document has no adverse impact?

Action Lead Date to be Achieved

None identified

8. Approval – At this point, you should forward the template to the Trust Equality and Diversity

Lead [email protected]

Approved by Trust Equality and Diversity Lead:

Date: 15.6.17

mailto:[email protected]

clinical audit policy - east cheshire nhs trust audit... · policy title: clinical audit policy...

Documents