the voice of NHS leadership

The bureaucratic burden in the NHS

The voice of NHS leadership

The NHS Confederation is the independent membership body for the full range of organisations that make up the modern NHS. We bring together over 90 per cent of acute trusts, foundation trusts, ambulance trusts, primary care trusts, mental health trusts and independent sector providers. Our common vision is excellence for patients, the public and staff by supporting the leadership of the new NHS. We help our members improve patient care and public health, by: influencing policy, implementation and the public debate, speaking out independently supporting leaders through networking, sharing information and learning promoting excellence in employment. This report has been written in collaboration with Professor Ellie Scrivens, Director of the Health Care Standards Unit, which is funded by the Department of Health, based at Keele University. The views and recommendations expressed here are those of the Confederation and not necessarily those of the Department of Health.

For more information on our work, please contact: The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org Registered Charity no. 1090329 Published by the NHS Confederation NHS Confederation 2007. This document may not be reproduced in whole or in part without permission. ISBN 978-1-85947-134-0 BOK 57401

Contents
Executive summary Introduction Is there such a thing as a bureaucratic burden within the NHS? What is perceived as a burden? What contributes to the perception of the bureaucratic burden? Conclusion Annex A: Bodies which can review NHS trusts Annex B: Bodies that assess or monitor similar standards in relation to safety 2 4 5 7 11 15 17 22

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Executive summary
Whilst the government and regulators have made commitments to reduce the regulatory burden, the perception amongst NHS organisations is that the burden is increasing. The present regulatory processes are piecemeal and complex. The landscape of regulation is confused, being made up of many different bodies who hold different statuses in the hierarchy of regulators and who have different powers to control behaviours. In fact, there are so many bodies that inspect, assess or monitor the NHS that it is extremely difficult to identify the precise number. The list compiled for this report, attached at Annex A, is the most up-to-date and accurate list that currently exists. NHS organisations recognise that regulation and inspection are important both in terms of providing public assurance on safety, quality and value for money and in driving forward improvement locally. However, regulation and assessment need to be proportionate in accordance with the principles for better regulation as outlined by the Better Regulation Executive.1 Assessment and information requests must align with what is genuinely required to run an organisation efficiently. There is still a real concern that significant parts of the current inspection and regulatory requirements and demands on the NHS do not meet these criteria. The various assessment bodies use different approaches to audit and inspection. Frequently, they use standards which are similar but worded differently. Organisations are therefore required to submit different versions of the same information to a number of different regulators and national bodies that inspect or assess the NHS. The sheer number of inspections, standards and volume of information required to demonstrate compliance is making it difficult for NHS organisations to extract value from these various processes and use them to drive improvement in services for patients. The Standards for Better Health have not produced a single standards framework for use by monitoring bodies. The Concordat has not had the effect members had hoped as it is currently not obligatory and is mostly concerned with coordination of visits and inspections rather than coordinating and aligning the content of the information or evidence gathered by NHS organisations so that this can be shared. The regulatory review is an opportunity to address these concerns and get a regulatory regime that is fit for purpose by being more effective in focusing on public assurance and creating a culture of challenge and improvement in the NHS.

1 The principles for better regulation: Proportionate regulators should only intervene when necessary. Remedies should be appropriate to the risk posed, and costs identified and minimised. Accountable regulators must be able to justify decisions and be subject to public scrutiny. Consistent Government rules and standards must be joined up and implemented fairly. Transparent regulators should be open and keep regulations simple and user friendly. Targeted regulation should be focused on the problem and minimise side effects.

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Given that primary legislation will establish the new regulator and define its functions, there is now an opportunity to reassess the regulatory and inspection framework which has in some cases given rise to overlapping remits. The current Standards for Better Health must be reviewed and reduced to constitute no more than a minimum set of standards that will guarantee NHS organisations and non-NHS organisations entry into the market (registration). Driving forward improvement should be a matter for individual organisations and their boards in the plural health market, not the regulator. All other standards used to assess the NHS must be coordinated with the minimum set of standards. The purpose behind information collections must be scrutinised and agreement reached where only what is necessary gets measured, so that the number of bodies that currently place demands on the NHS is streamlined. Any other organisation that monitors or assesses the NHS and that requires any

further or differently framed information, must justify and demonstrate its reasons for requiring additional information. Sharing of information between regulators should become the norm to reduce the duplication of activity on the ground in demonstrating compliance. The Concordat should be strengthened and extended to all organisations that have a remit to inspect, assess, ask for information or monitor the NHS. It must cover the coordination of visits but also ensure that regulators are joined up and that there is no duplication of information provided to them. The number of inspections and data collections within the NHS must be rationalised and driven down. Those inspections that are retained must be managed in a manner that does not lead to regulatory creep or cause unnecessary evidence gathering.

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The bureaucratic burden in the NHS

Introduction
For some time, NHS Confederation members have been arguing that the burden of reporting and providing evidence to external bodies is increasing rather than decreasing. In spite of considerable efforts by the Government and the Department of Health (DH) to address the burden of bureaucracy, there are perceived to be more and more demands on the time and energy of NHS organisations. If we are to move towards a system based on plurality of providers, patient choice, strong commissioning, increased patient and public involvement and public confidence in the quality and safety of our services, it is imperative that the current systems for monitoring and evaluating the NHS are streamlined and improved. The Governments review of the wider regulatory regime is now part of the consultation on the future of system management and regulation in health and adult social care. This provides a good opportunity for us to look at the current regulatory regime, analyse where there are problems and suggest a way forward. The NHS Confederation has therefore, as part of its on-going dialogue with members on the burden of bureaucracy, undertaken a short study, including visits to participating trusts, to look at three things: How real is the bureaucratic burden in the NHS? What is the extent of the bureaucratic burden? What can be done to reduce it? This report deals with the concept of the bureaucratic burden by looking at members perceptions of what that constitutes and how it manifests itself within the NHS. Asking members about their perceptions and looking at their anecdotes allowed us to take a step back and analyse what the wider regulatory landscape in the NHS looks like and, therefore, pinpoint what the explanations for the perceived burden could be. As such, this is not a report about members experiences and views on bureaucracy in the NHS, as this has been well documented, but an analysis of how the current system gives rise to the perception of duplication and a burdensome regulatory and inspection regime. This report concludes that it is the evidence and data collection requirements placed by various bodies on NHS organisations that generate the perception of bureaucratic burden.

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Is there such a thing as a bureaucratic burden within the NHS?

The evidence about the scale and the nature of the bureaucratic burden in the NHS is limited, but that which exists demonstrates that the NHS is required to produce considerable amounts of information, much of which appears to the organisations themselves not to be useful in managing the NHS. In 2003, the NHS Confederation carried out a small survey of data collection and reporting within the NHS, and subsequently published a briefing called Smarter reporting.2 The aim of the survey was to record and analyse information requests and reporting requirements in participating trusts for a period of one month, looking at where the requests came from and how much time was spent collecting and sending information. The survey also looked at the usefulness of the information to boards or managers in the management of their organisations. The findings were that strategic health authorities (SHAs) and the DH were responsible for more than 60 per cent of the data requests placed on NHS organisations, the reporting was on average required monthly, and the data returns took medium to high effort to collate. In addition, a large proportion (58 per cent) of the data collated could not be used for any internal purpose, nor was it seen as useful. Smarter reporting was a small study, with a sample of data collections from one month only. It cannot be seen as a definitive measure of the total burden placed on trusts in relation to data collection. It did, however, draw attention to a problem that has since led to further studies and investigations. In 200405 the DH undertook a further review of information collections, with the aim of reducing the burden on NHS staff. This study, published in 2006, titled Review of NHS data collections,3 looked at the impact of data collections on the NHS and NHS front-line staff, who was responsible for the workload and what was the scope for reducing the impact. Its key finding was that the DH had indeed reduced the number of data requests but there were still, on average, 600 collections per year, mostly at the behest of the SHAs. In 2006, the DH estimated that the total cost of the administrative burden4 placed on the private sector in relation to healthcare was in the region of 1,201.9 million. In response, the DH, along with all other Government departments, has published a simplification plan, outlining its approach to tackling the burden of bureaucracy, which impacts on both the private and public sectors. To improve the coordination of inspections carried out by different bodies, the Healthcare Commission has introduced a voluntary Concordat between bodies which inspect the NHS.

2 Smarter reporting. NHS Confederation briefing 92. December 2003 3 Review of NHS data collections 2005: report for the Department of Health and the NHS Health and Social Care Information Centre. DH, July 2006 4 Defined as: The recurring costs of administrative activities that businesses are required to conduct in order to comply with the information obligations that are imposed through central government regulation. DH, 2006

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Members views and methodology

Participants in this study clearly stated the importance of the function of external review to deliver high-quality, safe and accountable services to their patients and communities. External review was felt by many to work well when useful recommendations resulted from the review process: recommendations contribute to success and lead to demonstrable improvement for patients. However, despite the efforts by the DH and the Concordat to address aspects of data collection and inspection, NHS Confederation members still report that the burden of bureaucracy is increasing. To find out precisely what this means, we asked our members to explain their understanding of the term bureaucratic burden. In general, the responses related to external assessment or inspection processes which asked for more information than was necessary or useful:

The burden in terms of regulation is where the inspection framework is more intrusive than the remit allows or should allow. We asked our members to identify the external review bodies which they believe to be the main sources of bureaucratic burden and to demonstrate the amount of evidence they gather for each of them. In doing this we undertook five visits to both foundation trusts and non-foundation trusts to carry out qualitative interviews and found a striking similarity of concerns. We spoke to chief executive officers (CEOs), directors or deputy directors of clinical governance, medical directors and other board members. This study was undertaken as part of an on-going dialogue with members on the burden of bureaucracy in the NHS, and as a way of looking at whether improvements have been made since 2003. This allowed us to analyse the current regulatory and inspection regime in the NHS, and to make some key recommendations for the DH consultation on the future of system management and regulation in health and adult social care.

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What is perceived as a burden?

Too wide ranging
Contributors to both this study and the wider NHS Confederation debate about regulation state that regulation should be helpful but it often lacks meaning because of the breadth and depth of the topics covered. The Annual Health Check was frequently reported to be overwhelming and lose its meaning because of its wide-ranging nature. Members also questioned whether they could ever undertake such extensive assessments well enough. They reported that the assessment process for the Healthcare Commission requires 500 separate information topics to be addressed. Members felt it would be more useful to focus on specific services, safety and the impact on patient care, which would enable them to address quality, rather than focusing on the production of a large set of documents.

The Annual Health Check

The Annual Health Check has 24 core standards and, from 2006/07, 13 developmental standards, with several hundred accompanying criteria or lines of enquiry which the Healthcare Commission defines. It is a challenge to ascertain not only what information is required to demonstrate compliance but also the level or quality of the information. To what extent can the quality of the data be trusted with this number of elements? How can we meaningfully improve our practice and services?

be justified by the slightly different format of the data/evidence requested. The perception of the burden further intensifies when there is little or no direct benefit to the organisation of collecting the data. This is further multiplied when the various inspectorates require data in different formats which do not take into account the ways in which data is recorded or used within NHS organisations. And, more significantly,

Duplication
Members stated that uncoordinated visits and inspections did contribute to the burden, but that inspections were only secondary to the main source of burden the quantity and the nature of the evidence and data demanded by inspectorates and other external bodies. The burden intensified when requests for similar information and evidence were repeated by different inspectorates and other NHS bodies such as SHAs and PCTs. There was frustration at the lack of coordination of the topics assessed by reviewers, resulting in broadly similar information being provided on the same topics to different bodies, with a consequent use of trust resources. The Clinical Negligence Scheme for Trusts (CNST) and the Annual Health Check were frequently cited as overlapping in terms of the evidence they requested. Interviewees saw this duplication as a drain on resources that could not

Clinical Negligence Scheme for Trusts (CNST) and the Annual Health Check
Information collated to comply with the CNST review is comprehensive, yet the Annual Health Check requires further evidence to comply with its own safety standard in addition to a trust receiving a CNST level. The duplication or perception of overlapping remits emerges when a trust has already provided information for CNST but the Healthcare Commission does not accept this, which means the trust needs to state the level achieved in addition to providing all the material again.

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The bureaucratic burden in the NHS

The Mental Health Act Commissions Count me in census

This annual census records the age, gender and ethnicity of all patients detained in mental health and learning disability inpatient services. The census, in addition to collating data, requires face-to-face interviews with 20 detained service users. Significant planning is needed to facilitate the interviews, and transferring patients where necessary can pose logistical challenges, especially for patients from high and medium secure units. It also demands a significant amount of time to explain to service users, who have reported some anxiety and suspicion of the purpose of the interviews. Whilst the value of the census was not questioned, there was a perception that a lot of the information gathered here was also requested in a subsequent review by the Healthcare Commission. NHS Confederation members have reported that the information required by inspectors and data collection processes are frequently neither useful to boards in their work to drive forward improvement nor to ensure high-quality and safe services.

Commission in an attempt to reduce the burden of inspection had in fact simply shifted the burden from inspection to the internal collation of evidence and the internal process of self-declaration. Whilst members welcome the shift to self-declaration, the reference to a light-touch regulatory regime is misguided as this implies a reduction in the number of visits or inspections only, whereas members felt that the most burdensome aspect is the gathering or collection of evidence prior to an inspection or signing the declaration.

The administrative impact

Many members reported that they had changed their organisational structures and internal practices to meet the reporting requirements. Although many reported that this had a positive impact in that it allowed them to rethink their governance structures and processes, the management and administrative burden imposed by internal reorganisation should be recognised. Members also reported that NHS organisations computer systems are frequently not configured to generate data in the way inspectors require it. NHS resources are diverted to chase information for inspectors or to reformat existing data, which further contributes to the burden. Members also reported inadequate administrative infrastructures to support the growing external demand for information.

Shifting the burden onto the organisation

Members also pointed out that the new process of assessment developed by the Healthcare

Self-declaration
A large percentage of the information required for the Commission for Health Improvement was sent away for external review, but the current shift demands increased internal analysis. In addition, the shift to self-declaration has led to confusion as the standards and criteria produced by the Healthcare Commission do not provide sufficient guidance on the kind of documentation NHS organisations should produce to demonstrate compliance. Because of this, boards do not feel confident that they understand the level or kind of documentation required or how the evidence will be weighted. This has led to an increased feeling of a burdensome system where the board has to second guess what the Healthcare Commission is looking for.

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Documented evidence
Visible evidence must be supported by documented evidence. For example, physical proof of the installation of single-sex wards and a new toilet block were not formally acknowledged by the Healthcare Commission in one trusts experience of the Annual Health Check as there was no paperwork to verify the adaptations. This has led to increased administrative procedures in producing detailed paper work that would otherwise be deemed unnecessary. This gives the impression that process is more important than outcome.

Format
Not knowing how data can be manipulated to fit the required format, or lack of knowledge about the systems in place, further increases the time it takes to complete a request. Information may be required to be submitted both electronically and in hard copy. This was considered time consuming and unnecessary.

that clinicians had felt that existing trust data was sufficient and appropriate for the Annual Health Check but had had to spend considerable time and effort representing the information to comply with the required format. Many members also reported that considerable additional effort is required to prepare for reports, reviews and visits beyond the working day. Some external review processes also call for considerable clinical engagement. Senior clinical staff are called upon to prepare information, check data and be available for interviews on the day.

Impact on the staff and clinical front line

Frequently, the format of the data required by the review/inspectorate is different from that collected routinely in trusts. For example, members reported

Foundation trusts
Foundation trusts shared many of the same concerns as other NHS trusts on the regulatory burden. However, they also raised concerns

Stability over time

Going through a robust process for the first Annual Health Check to ensure the board could satisfy itself that the organisation was compliant, was for some members a valuable exercise. However, they questioned the value of going through the same process to the same extent year on year, and wondered if the NHS should not be afforded stability over time, where the standards according to which they are assessed are minimised once they have demonstrated that they meet them. After this, it should be the individual organisation that drives forward improvement.

Annual Health Check visit

Despite six months preparation and maintaining good information as a matter of course, in one trust considerable staff input and additional hours of work were required following the two-week notice period issued prior to the Healthcare Commissions Annual Health Check visit, including evening work and weekends. Senior management and clinical staff were also required during the visits and for various interviews.

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The bureaucratic burden in the NHS

Clinical Negligence Scheme for Trusts (CNST)

CNST was cited as a useful and rigorous procedure, but for some was the most onerous. Evaluating the standards was an ongoing task, while an assessment demands six months preparation. For example, in one trust the month prior to assessment requires 75 per cent of a whole time equivalent (WTE). For maternity, there is a full-time risk manager and an additional 1.5 WTE would be needed. Others reported one person being required for 40 per cent of their time, collating evidence, and two full-time staff for 12 months. Directors and senior managers are essential to ensure the systems are in place, while the actual guidance, project management, collation and management of the evidence is done by the clinical risk manager and other members of the risk department.

about the need to prevent mandatory standards from proliferating to a degree that inhibits the development of meaningful local targets. As self-standing organisations with new local governance arrangements, foundation trusts felt that devising stretching local targets to reflect local priorities was a key part of their engagement with and accountability to local communities. The regulatory framework needed to create enough space to enable this to happen. Foundation trusts reported a reduction in the reporting burden as a result of the end of performance management by SHAs. However, whilst welcoming key components of the risk-based regulatory regime for foundation trusts, there were still real concerns about the regulatory burden and the potential for overlap and double jeopardy, particularly between the Healthcare Commission and Monitor.

Cancer Peer Review

The Cancer Peer Review was found to be very useful although resource intensive, because it allows organisations to take real steps in response to recommendations which lead to improvement. However, it also involves a large set of standards with further subsets (102 standards on chemotherapy alone) set out in the Manual for cancer services, which is a considerable undertaking. The key issue reported was that because it involves consultants reviewing other services in an area, smaller hospitals are under more pressure as the review has to be undertaken in addition to everyday clinical duties. Like a lot of the inspections or declarations, senior clinical input at executive level is required for signing off submissions. Whilst understandable, it should be recognised that inspections and assessments impact on front-line staff and very senior staff in a lot of cases.

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What contributes to the perception of the bureaucratic burden?

An analysis of the current regulatory landscape in the NHS
The present regulatory processes are piecemeal and complex. The landscape of regulation is confused, being made up of many different bodies who hold different statuses in the hierarchy of regulators and who have different powers to control behaviours. There are regulators with general powers of enforcement and some with specific powers relating to the NHS. Some are public bodies, some are DH creations and some are generated by the NHS itself. Others are advisory bodies that produce guidance and requirements for NHS organisations to follow, whereas some have powers to investigate and scrutinise NHS work and some have chosen to inspect NHS services, although without explicit powers to do so. Together they place a considerable burden on the NHS, which has to produce information to meet their differing requirements for evidence and allow its activities to be open to scrutiny. The Better Regulation Task Force report, Independent regulators, of October 2003, highlighted the need for bodies performing regulatory functions to be identified. The Cabinet Office Directory of public bodies 2005 identified only ten out of a total of 68 bodies that relate to the DH which it considers perform a regulatory function.5 It defines regulation as: " exerting powers over, or imposing burdens on, other organisations or individuals; by means of inspection, licensing, referral to another decision-maker (particularly with binding advice), accreditation or enforcement. However, the number of bodies which can inspect or impose burdens on the NHS is in reality far greater than the ten suggested. This creates ambiguity in determining the bureaucratic or regulatory burden. There are the national regulators which have powers over all businesses,

5 The ten bodies are: Commission for Social Care Inspection Executive (non-departmental public body (NDPB)) General Social Care Council Executive (NDPB) Human Fertilisation and Embryology Authority Executive (NDPB) Human Tissue Authority Healthcare Commission Mental Health Act Commission (NHS body) Monitor Independent Regulator of NHS Foundation Trusts Executive (NDPB) National Institute for Clinical Excellence (NHS body) Patient Information Advisory Group (advisory NDPB) UK Xenotransplantation Interim Regulatory Authority (advisory NDPB)

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such as the Health and Safety Executive; and there are those which are intended to provide a scrutiny function. The Mental Health Act Commission, for example, is defined by the Cabinet Office as a regulator because of its inspection function, although the Cabinet Office claims it would normally be called a monitoring body rather than a regulator. The NHS Litigation Authority (NHSLA), in contrast, is not included in the list of regulators as, although it uses inspection as a condition of participation, its inspections are not technically mandatory. So, although the NHSLA inspects more NHS organisations than the Healthcare Commission, the former is not included in the Cabinet Office definition of an organisation which imposes a burden, whereas the latter is. The number of bodies which can insist that the NHS collates data and evidence is large. In 2006, Central Manchester and Manchester Childrens Hospitals NHS Trust and the Healthcare Standards Unit independently reviewed the number of bodies that can inspect or review NHS organisations activities. A combined list is attached in Annex A. The list is extensive but, however, not exhaustive, and demonstrates the wide range of activities within the NHS that are monitored by external agencies, auditors and regulators. In fact, there are so many that it is extremely difficult to identify the precise number. Some are public bodies recognised by the Cabinet Office, others are bodies from within the NHS itself. There are bodies which have a relevance to the quality of healthcare and that can impose sanctions on healthcare organisations, such as the Royal Colleges. Some are independent organisations which have been developed to support the scrutiny of NHS work and that have become recognised as important contributors to the system of scrutiny, such as the Clinical Pathology Accreditation Scheme.

The Hampton Report6 proposed that the decision on the acceptable level of policy costs for a particular outcome reflects the political decision on the regulatory goal to be achieved. The administrative cost is overhead and should be reduced to the minimum level required to ensure the effective enforcement of the regulation. In healthcare, however, the assumption that there should be not only demonstrable control of compliance with laws and specific regulations to protect individuals and communities from harm, and public accountability issues such as value for money, but also control over the quality of services and care provided, has generated large numbers of bodies whose purpose is to monitor and sometimes intervene in the delivery of health services. As a consequence, in any single year, a hospital can in theory receive visits from a wide range of bodies whose role is to monitor or scrutinise its activities. Annex A documents a selection of bodies which can assess NHS organisations this is the most up to date and accurate list to date but there are many more, particularly if local assessment processes such as those run by SHAs or PCTs are included. With the inclusion of the Royal Colleges and their various assessment systems, estimates of the number of external assessors able to review hospitals exceed

6 The Hampton Report was published in March 2005 by HM Treasury. Hampton found that there is much good practice in UK regulation, but also that the system, as a whole, is complicated and good practice is not uniform. Overlaps in regulators activities mean there are too many forms, too many duplicate information requests and multiple inspections imposed on businesses. The report suggested that the costs of regulation which fall on the regulated can be split into two types: Policy cost is the cost inherent in meeting the aims of a regulation. This could be a direct cash cost, such as installing a new waste incinerator prescribed by legislation, or it could come indirectly, for instance through changes to a factory in order to meet new health and safety regulations. Administrative costs are those costs that are incurred in gathering information about a business, or checking on a businesss compliance. So, for instance, filling in a form is an administrative cost, as is showing an inspector around a site.

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60. This creates both the perceived and actual administrative burden.

Different interpretations of the meaning and the use of standards contributing to a perception of increased bureaucracy
The various assessment bodies use different approaches to audit and inspection. Frequently, these use standards which are similar but worded differently, placing different requirements to produce evidence on NHS organisations. A number of monitoring organisations have begun to adopt the Standards for Better Health as a template against which to assess NHS organisations. However, their approaches to the adoption of the Standards for Better Health vary. Some have adopted the internal structure of the Standards for Better Health, copying the distinction drawn between core and developmental standards, but devising their own standards within this split. Others have adopted the domain headings of the Standards for Better Health and devised their own standards within these. Others have mapped their existing standards to the Standards for Better Health to justify their existing standards against the framework. The NHS Litigation Authority (NHSLA), in its review of its standards, reported that: one of the most frequently recurring themes was the request to ensure that there is alignment between the revised NHSLA standards and assessments and the Department of Healths Standards for Better Health and Healthcare Commissions assessments. The NHSLA announced its intention to crossreference its standards to the corresponding Standards for Better Health to assist trusts. Others,

such as NHS Professionals, the Royal College of Psychiatrists and the National Treatment Agency, have taken similar measures. But, as shown above, members feel that cross-referencing by these various bodies has not resulted in a reduction of bureaucracy but has possibly contributed to greater duplication. The process of aligning standards is therefore not enough to achieve the required reduction in terms of burden.

Duplication of activity
Members feel that aligning standards to the Standards for Better Health is a futile process if this does not at the same time lead to greater cooperation between organisations that assess, inspect or audit the NHS, so that information does not have to be collated twice. Although there is common ground between some of the inspection frameworks, as shown above, and viewing the situation from a regulators point of view tells us that the emphasis is different and that there are no significant areas of overlap, the experience on the ground tells us that what is considered to be a different set of standards to a regulator feels like duplication within the NHS because it relies on the same or similar information that has already been collated for a different organisation. A key factor contributing to the perception of bureaucratic burdens is, therefore, duplication of activity by assessors. There are considerable similarities in the topics studied and the assessment standards used by different monitoring agencies. The Standards for Better Health have not produced a single standards framework used by all monitoring bodies, and some aspects are covered by some bodies and other aspects by others. Indeed, the Concordat actively seeks to establish where there are common grounds between monitoring agencies. The perception of a

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The bureaucratic burden in the NHS

burdensome system is intensified when broadly similar evidence is produced for different regulators, and the process of aligning inspection activities does not address the root cause of the burden, which is duplication in the focus of inspection and assessment activities. An example of this kind of duplication is attached in Annex B, where several frameworks request information on a very similar topic. There are similarities in the inspection approaches adopted by a number of monitoring bodies who use standards, but some regulators are moving

to different assessment approaches. This is a potential source of increased burden. For example, the Healthcare Commissions annual performance ratings or scores have been described by Monitor as retrospective and more broadly focused. Monitor, in contrast, appears to favour regular surveillance of providers and patient pathways across a whole range of clinical indicators rather than assessment against national standards for this purpose. Different approaches to assessment and audit can increase data collection and collation and lead to an increase in burden.

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Conclusion
Summary
NHS Confederation members regard regulation and inspection as an important part of running an effective and high-quality service, but it is a cause for concern that the extent to which the NHS is regulated and inspected is unknown. The range of external bodies undertaking similar monitoring tasks must beg the question: is the monitoring as efficient and effective as it should be to deliver modern healthcare? The DH consultation document on the future of system management and regulation, published in November 2006, gives us an opportunity to evaluate what functions we want regulation and the independent regulator to perform and what regulatory functions must be carried out elsewhere in the system. As has been demonstrated, there is a perception amongst NHS organisations that the bureaucratic or regulatory burden emerges where there is duplication of activity either in terms of information gathering, audits, inspections or reviews and visits. It is not the alignment or misalignment of standards that creates the perception of the burden, but assessment or inspection frameworks that require evidence or information for purposes that on the ground are interpreted as similar. In addition, the lack of recognition between inspection or regulatory frameworks increases the perception of bureaucratic burdens in the NHS. The perceived administrative burden of bureaucracy can therefore be attributed to a number of different causes. These are: a large number of national and local bodies, intended to address different facets of quality, safety and compliance with regulation, which can inspect hospitals a large number of policy documents issued by the DH and other bodies a large set of information reporting requirements, some of which generate local assessment processes large sets of standards issued by different bodies, which can cover similar topics differential use by national standard-setting bodies of the Standards for Better Health as a national framework around which to organise standards frequent changes to standards and introduction of new standards different assessment approaches conducted at different frequencies and requiring different evidence to demonstrate compliance differential use of self-assessment tools and inspections, which results in inspectors asking for information similar to that provided for other bodies in a different form different assumptions by regulators about the appropriate methodologies to adopt.

Better regulation
The purpose of regulation may seem self-evident, but when it is not made explicit the tangible benefits quickly become lost. Regulation and inspection as an activity is not an end in itself but only fulfils its purpose insofar as it helps NHS organisations assess themselves as a means to driving forward improvement as well as providing public assurances regarding quality and safety of the service. The key principles following visits to and interviews with NHS Confederation members can be summarised as follows: There is a clear balance to be struck between the breadth and depth of regulation and the benefits

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The bureaucratic burden in the NHS

that stem from it. Regulation and assessment need to be proportionate in accordance with the principles for better regulation as outlined by the Better Regulation Executive. Assessment and information requests must align with what is genuinely required to run an organisation efficiently. Some activities will attract a level of regulatory scrutiny that could be termed double jeopardy. However, dual regulation must produce a genuinely triangulated picture of the service to justify the additional effort involved. A requirement to resubmit the same data, or the reliance of one regulator on anothers findings, is insufficient in this case. Driving forward improvement will be a matter for individual organisations and their boards, not the regulator, in the plural health market.

The number of bodies able to inspect or require data collection should be reviewed and streamlined. Sharing of information between regulators and other organisations that monitor or assess the NHS should become the norm to reduce the duplication of activity on the ground in demonstrating compliance. The number of inspections and data collections within the NHS must be rationalised. Those that are retained must be coordinated in a manner that does not lead to regulatory creep or cause an unnecessary activity of evidence gathering. The Concordat should be strengthened to ensure greater collaboration and cooperation between all bodies that inspect, monitor or assess the NHS. Its remit must be to reduce duplication of regulatory or assessment activity experienced on the ground as well as duplication of visits. The full range of stakeholders, led by the DH, should undertake a review of all current inspections, assessments, information requests and audits in the NHS, with a view to streamlining the number of bodies that place demands on the NHS. The purpose behind information collections must be scrutinised and agreement reached where only that which is necessary gets measured, so that the number of bodies that currently place demands on the NHS is streamlined. Any further information required by any other organisation that monitors or assesses the NHS must justify and demonstrate its reasons for requiring additional information. The NHS Confederation looks forward to working with stakeholders in addressing issues raised in this report and how improvements to the current regulatory and inspection frameworks could be taken forward.

Recommendations
If we are serious about NHS reform and all that it entails, then it logically follows that a change in terms of the regulatory and inspection system is needed. We cannot enter the new NHS with all the baggage of a past system that in the new climate will simply not be fit for purpose. Our recommendations are: The current Standards for Better Health must be reviewed and reduced to constitute no more than a minimum set of standards that will guarantee NHS organisations and non-NHS organisations entry into the market (registration). All other standards used to assess the NHS must be coordinated with the minimum set of standards, and all the bodies using the framework should adopt the same interpretation of them and agree a common dataset to allow compliance to be measured.

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Annex A
Bodies which can review NHS trusts
Third parties with statutory enforcement powers specific to healthcare
Can visit NHS trusts

*Human Fertilisation & Embryology Authority (HFEA) To be replaced by the Regulatory Authority Tissues and Embryos 2008 *Human Tissue Authority (HTA) Medicines and Healthcare Products Regulatory Agency Monitor Independent Regulator of NHS Foundation Trusts

  

*Due to be changed or disbanded

Third parties with general statutory enforcement powers and that can visit hospitals
Can visit NHS trusts

Environment Agency (Waste management licencing) Fire authorities Health and Safety Executive Information Commissioner National Audit Office Local authority environmental health departments Audit Commission

     

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The bureaucratic burden in the NHS

Third parties with a specific statutory role in healthcare but no enforcement powers
Can visit NHS trusts

*Commission for Social Care Inspection (CSCI) *Healthcare Commission (Commission for Healthcare Audit and Inspection) *Mental Health Act Commission (MHAC) Overview and scrutiny committees of local authorities

    Will in future

*Patient and public involvement (PPI) forums and the Commission for Patient and Public Involvement in Health Council for Healthcare Regulatory Excellence General Chiropractic Council General Dental Council General Medical Council General Optical Council General Osteopathic Council Health Professions Council Nursing and Midwifery Council Pharmaceutical Society of Northern Ireland Royal Pharmaceutical Society of Great Britain

 

*Due to be changed or disbanded

The bureaucratic burden in the NHS

19

Third parties with no statutory role but a legitimate interest in healthcare

Can visit NHS trusts

Health Protection Agency (HPA) National Patient Safety Agency (NPSA)

  For some programmes    For some programmes

National Treatment Agency for Substance Misuse National Institute for Innovation and Improvement NHS Business Services Authority Counter Fraud and Security Management Dental Practice Division Pensions Division Prescription Pricing Division Supply Chain Management Division Hosted and Managed Services NHS Litigation Authority Royal College of Anaesthetists Royal College of GPs Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists Royal College of Ophthalmologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Physicians Royal College of Psychiatrists Royal College of Radiologists Royal College of Speech and Language Therapists

            

continued over

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The bureaucratic burden in the NHS

Third parties with no statutory role but a legitimate interest in healthcare

Can visit NHS trusts

Royal College of Surgeons Postgraduate Medical Education and Training Board Royal Pharmaceutical Society Skills for Health

   

Department of Health initiatives involving standards

Can visit NHS trusts

Cancer Peer Review Peer Review of Cancer Registries Cancer Screening QA Breast cancer quality assurance review NHS Estates cleaning NHS Estates patient environment action teams Health Information Accreditation Scheme Accreditation scheme for tissue banks

       

NHS developed review bodies

Can visit NHS trusts

North Central London SHA library accreditation A Quality Network for Inpatient Child and Adolescent Psychiatry

 

The bureaucratic burden in the NHS

21

Examples of voluntary bodies invited by hospitals to visit them

Can visit NHS trusts

Investors in People Clinical Pathology Accreditation Ltd Health Quality Services Hospital Accreditation Programme Health Promoting Hospitals Child Health Informatics Centre The National Autistic Society

      

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The bureaucratic burden in the NHS

Annex B
An outline of bodies that assess or monitor similar standards in relation to safety
Selected safety topics
(as identified in the concordat mapping document) (as identified in the concordat mapping document)

Standard subcategory

Information about the service (patient guide) Explanation of clinical procedures Competent staff safe hands Supervision (clinical or equivalent) Employment checks and recruitment (carried out) Internal training Consent Risk management system Adverse events Monitoring clinical activity Records of incidents Complaints

  

  

  

 

 

 

 

 

  

      

Information Governance Toolkit 

Audit Commission

NHSLA level one only

HC criteria

S4BH

PEAT

Health and Safety Executive

The bureaucratic burden in the NHS

23

Selected safety topics

(as identified in the concordat mapping document) (as identified in the concordat mapping document)

Standard subcategory

Whistleblowing Safety notices Safe environment Medicines and medication Medical devices, including decontamination Waste management Records management Infection control Health and safety Housekeeping/clean environment Child protection (and vulnerable adults) Research Following NICE requirments National Service Frameworks

  

    

    

       

 

  

 

 

 

Information Governance Toolkit

Audit Commission

NHSLA level one only

HC criteria

S4BH

PEAT

Health and Safety Executive

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The bureaucratic burden in the NHS

Patient experience
HC inspection criteria
(as identified in the concordat mapping document)

Information Governance Toolkit

Audit Commission

Standard subcategory

Resuscitation No discrimination access Confidential discussions Bullying of patients or staff Confidentiality Service privacy and dignity Choice Environmental support to privacy and dignity Meals and mealtimes Comfortable environment Security of personal possessions Religious, cultural preferences

Not explicit

NHSLA level one only

S4BH

PEAT

   

 Staff 

 D9

 

 

 

(as identified in the concordat mapping document)

Health and Safety Executive

The bureaucratic burden in the NHS

In spite of considerable efforts by the Government and the Department of Health to address the burden of bureaucracy, there are perceived to be more and more demands on the time and energy of NHS organisations. If we are to move towards a system based on plurality of providers, patient choice, strong commissioning, increased patient and public involvement and increased public confidence in the quality and

safety of our services, it is imperative that the current systems for monitoring and evaluating the NHS are streamlined and improved. This report examines this burden at a local level, looks at the potential reasons why the burden seems to have increased in the NHS, and presents recommendations for changing the regulatory system.

Further copies can be obtained from: NHS Confederation Publications Tel 0870 444 5841 Fax 0870 444 5842 Email publications@nhsconfed.org or visit www.nhsconfed.org/publications
NHS Confederation 2007 This document may not be reproduced in whole or in part without permission

The voice of NHS leadership

The NHS Confederation 29 Bressenden Place London SW1E 5DD Tel 020 7074 3200 Fax 0870 487 1555 Email enquiries@nhsconfed.org www.nhsconfed.org
Registered Charity no: 1090329

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ISBN 978-1-85947-134-0 BOK 57401