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Literature about clinical audit

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Guidance from other policy bodies

See below for a list of quick-links to the latest and/or most relevant guidance documents from independent organisations:

Clinical Governance within Primary Care

The National Audit Office actively works to identify and disseminate good practice through guidance, seminars, conferences and briefings. One such report relates to Clinical Governance within Primary Care, and contains useful guidance regarding clinical audit. More information

Clinical audit and the Audit Commission

Although the work of the Audit Commission is different to the work carried out by clinical audit teams, the two are related. HQIP have produced a document explaining the relationship and highlighting recent publications by the Audit Commission which have a bearing on clinical audit. Download here

Clinical Audit Handbook

The practical handbook for clinical audit was published by the Clinical Governance Support Team in March 2005, with the intention of improving clinical audit at a local level.

The handbook was designed for use in acute trusts, primary care trusts (PCTs), ambulance trusts and mental health trusts. There are many different models for clinical audit which work well at a local level and the handbook documents the range of models which are applicable and, where possible, gives examples of good practice.

The handbook was endorsed by the Care Quality Commission (formerly the Healthcare Commission), the National Institute for Health and Clinical Excellence (NICE), the Clinical Governance Support Team (CGST) and the National Audit and Governance Group (NAGG).

The handbook is currently in the process of being tendered, but in the meantime you can view the existing document here.

Clinical audit within PCTs

The National Clinical Governance Support Team (CGST) developed a Strategic Leadership Clinical Governance Development Programme for PCT Boards and Professional Executive Committee's (PEC's).

Within the programme there a chapter that focuses on the delivery of clinical audit. Click here to view the full document.

Clinical audit in national priorities and existing arrangements

The Care Quality Commission (formerly the Healthcare Commission) measures national priorities set by the Department of Health through the 2008-2011 planning round. Assessment of performance against the existing national priorities are components of the Healthcare Commission's annual health check in 2008/2009 for Primary Care Trusts (PCTs) and Acute and Specialist Trusts.

In March 2009, the Care Quality Commission will undertake a Special Data Collection through which acute and specialist trusts will be assessed on their responses to six questions that relate to clinical audit.

Further information about the construction of these questions can be found here.

Clinical audit is also measured in other national priorities and existing arrangements. To check the latest information from the Care Quality Commission, click here.

National priority indicators for acute and specialist trusts:

Existing commitment indicators for acute and specialist trusts:

Time to reperfusion for patients who have had a heart attack

Ambulance trust indicators:

Time to reperfusion for patients who have had a heart attack

Existing commitment indicators for primary care trusts:

Time to reperfusion for patients who have had a heart attack

Clinical Governance Support Team's Board Development Programme

The programme develops effective governance within NHS Trusts, Foundation Trusts, Strategic Health Authorities and inter-organisational governance structures such as the Cancer Network Boards. Chapter 12 is specifically about Clinical Audit. More information

Care Quality Commission 2009/10 reviews

Background

In 2008 the Department of Health began consulting on proposals for the registration of health and adult social care providers from April 2010 onwards, and the Care Quality Commission (CQC) has been consulting on registration requirements (the closing date for public consultation was 24th August 2009). These requirements will apply to all NHS providers from 1st April 2010 and to all adult social care and independent healthcare providers from 1st October 2010, and will replace ‘Standards for Better Health'. The draft standards contain a requirement at Section 13a (p78-9 of the draft guidance) that providers demonstrate the use of clinical audit monitor the quality of care and to protect against risk.

Once registration is implemented, the CQC will confirm how it will replace the familiar annual assessment of NHS Trusts performance with a system of registration and periodic review.

However, before these plans come into operation, the CQC has to fulfil its role as an independent regulator by assessing NHS trusts on their performance in 2009/10. In a document published in June 2009 the CQC set out its proposals and timetable for the 2009/10 reviews.

NHS Providers

For NHS providers, they have followed the Healthcare Commission's Annual Health Check approach, with trusts being required to make a declaration of compliance with core standards in November 2009, followed by checks and inspections carried out in the period from December 2009 to March 2010. The main focus of these inspections will be on driving forward improvements necessary for trusts to be able to meet the requirements for registration for 2010/2011 onwards - applications for registration need to be submitted in January 2010.

Trusts need to have these dates in mind when planning and prioritising their clinical audit programmes. The document sets out the indicators for primary care trusts, acute and specialist trusts, ambulance trusts, mental health trusts and learning disability trusts. There are specific references to clinical audit - for example, engagement in clinical audit and participation in heart disease audits are both included as indicators for acute and specialist trusts - but trusts which have carried out clinical audits in any of the indicator areas will not only have evidence of compliance, they will also be able to demonstrate a commitment to develop and improve the quality of their services in preparation for registration.

NHS Commissioners

While the plans for assessing provider services are essentially the same as those in 2008/9, there are some key differences for the assessment of commissioners of care. Primary care trusts as commissioners will not be required to make a mid-year declaration on core standards. Instead, the CQC will produce an aggregated score for each trust, based on performance against the ‘Vital Signs' framework. They will also report scores awarded under the World Class Commissioning assessment of competency and governance.

From a clinical audit perspective, one of the key areas which the CQC has asked commissioners to consider is whether they have appropriate mechanisms in place to be able to identify and, where appropriate, respond to concerns about the quality of the providers' services which they commission, and whether the assurance systems and processes they have in place reflect the implementation of full registration of NHS providers from April 2010. National clinical audit data and data from local audits provide one source of information which Commissioners can use in this process.

Planning for 2010 onwards

For the future, the CQC has stated its intention to focus post-registration periodic reviews on looking at outcomes of care and service users' experiences. Reviews will make the maximum use of nationally available data and other organisations findings. The draft requirements state that registered care providers should use the findings from clinical audits, including those undertaken at a national level, and national service reviews to ensure that action is taken to protect people from risks associated with unsafe care, treatment and support, and that clinicians who work in the NHS should participate in NCAPOP audits if they provide a service that is covered by the programme. HQIP has worked closely with the CQC to ensure that they fully understand the range and diversity of national audits and the data they have available, and will continue to work with them to develop the ways in which local and national clinical audit can contribute to improving the quality of health care.

CQC report into West London Mental Health NHS Trust

July 09 - Learning for Clinical Audit

This investigation by CQC was triggered by concerns into the management of investigations into suicides within the West London Mental Health NHS Trust. One of the issues identified was that the same recommendations for action were repeated in each investigation report suggesting that lessons were not being learnt.

Recommendations

Recommendations from the report include the following:

A need for clear policies and procedures around reporting and investigations of incidents
The importance of completion of investigation reports within an agreed time frame
Reports must comply with agreed quality standards
When a review or audit is carried out recommendations must be actioned, with a process in place to assess subsequent quality improvement
Action plans should be developed by key staff with responsibility for implementing them
A clear risk is attached to quality of care by having low staffing levels but there is also knock on effect on reduced attendance for mandatory and other training
Key issues highlighted through clinical governance must be addressed appropriately eg. bed occupancy, staffing levels
Investigation of Serious Untoward Incidents (SUIs) must be treated by all, including executive and non-executive directors, with sense of urgency
Once a high risk area has been identified, a prevention strategy should be implemented.

Implications for quality improvement in general

There is a need for all providers of care to have a robust, clear and proportionate framework for investigations and reviews which focuses on nationally published good practice. The framework should also include sharing of knowledge and outcomes that will lead to continuous learning, promotion of best practice and ultimately improvements in quality of care
External scrutiny is important, where providers work together to manage reviews and share learning across healthcare economies
The monitoring arrangements for reporting, investigating and learning from incidents should be given priority as part of the commissioning process
There is a need to ensure that mental health trusts give physical healthcare a high priority so that users have access to same range of primary and secondary care services as other services users
There is a need to ensure that medicines management is also given high priority within mental health trusts.

Implications for clinical audit

Trusts should use documentation audits to ensure that all incident or investigation reports are of acceptable quality. The CQC report highlights that out of 37 investigation reports viewed 22 were un-dated
It is critically important that action plans are implemented and progress reviewed against the actions eg. through re-audit. The CQC investigation found that the same recommendations were being made after each incident
Key issues identified through clinical governance process eg. incidents, risks etc, should become part of the ongoing clinical audit programme and should be treated with appropriate sense of urgency.

For more information, contact lqit@hqip.org.uk.

Mid Staffs NHS Foundation Trust investigation

April 2010

The comprehensive report on Mid Staffordshire shows the harm and damage that can be done to individual patients and the entire NHS through poor management and inattention to the basics of clinical effectiveness.

Full report >>

Clinical Audit: A Simple Guide for NHS Boards & Partners >>

There is much that could be highlighted from the report, but the analysis of the failings on clinical audit is our main interest. The failure here was not restricted to the trust board and senior management, although they were responsible for ensuring that clinical audit happened and was part of their broader quality control system. However, the report is also clear that clinicians ‘abrogated responsibility with regard to the need for each clinician to audit his or her practice'. Whatever the responsibilities of management to oversee and drive quality improvement and measurement processes such as clinical audit, it is also a clinician's responsibility to audit their work.

In summary the report says:

Recommendation 5: The Board should institute a programme of improving the arrangements for audit in all clinical departments and make participation in audit processes in accordance with contemporary standards of practice a requirement for all relevant staff. The Board should review audit processes and outcomes on a regular basis.

Full report >>

We would add that clinicians need to ensure that they take responsibility for ensuring they have the skills and commitment to use clinical audit as a quality improvement process. Senior clinicians have a responsibility to promote the importance of clinical audit and champion good audit processes. This report makes it clear that clinical audit is essential if these kinds of problems are to be avoided and we would urge both clinicians and boards to identify and address any failings they have in their practice.

The publication of this report provides trust boards and senior clinicians with a real opportunity to review their systems and processes for reporting and discussing clinical audit at all levels throughout the trust. Practical and relevant resources are available on the HQIP website. Most notably our new report on ‘Clinical Audit: A simple guide for NHS Boards & partners.'

ORIGINAL BRIEFING FROM 2009:

Background

The Healthcare Commission carried out an investigation into apparently high mortality rates in patients admitted to Mid Staffordshire NHS Foundation Trust from March 2008 to October 2008 and produced a report of their findings in March 2009. As part of this investigation they looked at the systems for ensuring that patients were cared for safely and effectively, and discovered that clinical audit was one of the areas for improvement.

Implications for clinical audit

The report contains a number of observations on how clinical audit was managed within the Trust. The following recommendations have been drawn from these observations and can be applied to any healthcare organisation with responsibility for carrying out or monitoring clinical audit.

Each trust must have a clinical audit lead
Clinical audit teams should maintain a comprehensive database of all clinical audit projects being undertaken within their organisation
Clinical audit must be well planned and aligned against organisational, regional and national priorities
A clearly defined clinical audit planning process should be in place which is understood by both clinical and non-clinical staff
Clinical audit groups, including multi-disciplinary teams, should meet regularly with an agenda around quality improvement
The clinical audit cycle must be completed to ensure that improvements happen and are sustained
Clinical audit should be linked to other components of governance including complaints, risk management, and information governance
Evidence of poor standards of care or poor outcomes should be one of the triggers for clinical audit
Participation in national audits is effective way of comparing performance against others
The Trust board, or equivalent, must have assurance that clinical audit is being carried out effectively and results in improvements in quality of care for patients.

Progress review

The Care Quality Commission (CQC) has recently undertaken the first of three formal reviews of progress against the recommendations made in the original report. Part 2 and Part 3 of the progress review will be available in October 2009 and May 2010.

It is recognised that progress has been made and that mortality rates are showing early signs of improvement whilst also acknowledging that it is early days in the improvement process.

Whilst there is no direct reference to clinical audit in this first progress report, improvements have been highlighted within the overall governance system.

In addition to quarterly board meetings and a public council of governors meeting, a healthcare governance committee has been established
The system for handling serious untoward incidents has been improved
Incident reporting by staff has risen, which is seen as due to raised staff awareness rather than an indication of deterioration in care
The complaints service is managed by the Chief Executive and is being strengthened by introducing a cross directorate investigation process and the separation of the PALs service
Patient experience councils are being set up in each division and patient feedback is used to make improvements

Conclusion

At the end of the original report by the Healthcare Commission there are a series of national recommendations which all trusts can learn from, especially around quality of coding of clinical outcomes, use of comparative data, publication of mortality rates in a meaningful way, focus of trust boards on safety and quality of care, and the importance of patient experience data. In addition, commissioning organisations need to develop more effective ways of learning about the quality of care, the actual patient experience and the outcomes of the services they commission.

For more information, contact lqit@hqip.org.uk.

Opthalmology services

Audit is a fundamental part of clinical governance. It is a tool by which quality can be assessed, improvements instituted and their effectiveness monitored. All practices should have a framework of audit or review work within their systems. Guidance on undertaking clinical audit has been produced by the College of Optometrists.

Practices should be able to demonstrate such a framework exists and be able to evidence audit work being, or recently having been, carried out.

Quality in Optometry have also published guidance on Audit.

The Royal College of Ophthalmologists has made this statement about clinical audit.

The Association of Optometrists has published guidance and tools to support clinical audit.

The British and Irish Orthoptic Society has published guidance on undertaking clinical audit.

The British and Irish Orthoptic Society Competency Standards and Professional Practice Guidelines, section 1.5 make explicit the need for Ophthalmologists to participate in clinical audit.

The Clinical Governance Support Team published a Clinical Governance Resources Guide for Optometry.

Pharmaceutical services

Within the new community pharmacy contractual framework for England and Wales the Essential Service - the clinical governance requirements section explicitly refers to the requirement of clinical audit.

Section 2.2 stipulates that:
"Pharmacists and their staff should participate in clinical audit - at least one practice based audit and, one PCO determined multidisciplinary audit (to aid the development of team working) each year. The PCO must give reasonable notice to allow the pharmacist to leave the premises to participate in any local meetings relating to the multidisciplinary audit. Both audits must have a clear outcome, which will assist with developing patient care. The two audits should be capable of being completed within 5 days of pharmacist time."

The Royal Pharmaceutical Society of Great Britain (RPSGB) has published a series of templates and guidance documents to support pharmacists comply with these requirements. Click here for more information.

Clinical audit within foundation trusts

The NHS Foundation Trusts: Clinical and Service Performance states that "NHS foundation trust boards are collectively responsible for the full range of operations in their foundation trust and for all aspects of its performance including clinical standards, safety and quality. "

The Monitor Compliance Framework states that NHS Foundation Trust Boards are required to self certify that to the best of their knowledge and using their own processes, they are satisfied that their Trust has and will keep in place effective arrangements for the purpose of monitoring and continually improving the quality of healthcare provided to patients. In order to self-certify compliance, boards are expected to be able to:

describe their own objectives for improving quality
identify metrics to monitor quality in terms of clinical outcomes, patients/service user safety and experience, and the expected levels of performance
ensure that they have in place systems to improve quality.

Click here for a copy of the Monitor Compliance Framework.

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