Measurements for Improved Quality in Healthcare

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Measurements for Improved Quality in Healthcare

The English healthcare system is currently in a state of change. This country report is focused on initiatives for quality improvements, and quality-related measurements of healthcare in England. It is part of the Swedish Agency for Growth

Policy Analysis’ Health Measurement Project in which quality improvements and quality measurements in healthcare have been

England

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Reg. no. 2013/012

Swedish Agency for Growth Policy Analysis Studentplan 3, SE-831 40 Östersund, Sweden Telephone: +46 (0)10 447 44 00

Fax: +46 (0)10 447 44 01 E-mail: info@growthanalysis.se www.growthanalysis.se

For further information, please contact Martin Wikström Telephone: 010-447 44 73

E-mail: martin.wikstrom@growthanalysis.se

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Foreword

This country report is focused on policy initiatives for quality improvements of healthcare in England. It is part of the Swedish Agency for Growth Policy Analysis’ Health Meas- urement Project in which quality improvements and quality measurements in healthcare have been studied in a number of countries. The Swedish Ministry of Health and Social Affairs commissioned the project.

The report was written by Martin Wikström at the Agency’s Stockholm office whom also was the project leader of the multinational study.

Stockholm, April 2013

Enrico Deiaco, Director and Head of Division, Innovation and Global Meeting Places

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Summary

The responsibility for healthcare is devolved in the United Kingdom and is the responsibility of the individual countries, England, Wales, Northern Ireland and Scotland. The discussion in this paper concerns England only unless otherwise stated.

The English healthcare system is currently in a state of change, and as a result of the Health and Social Care Act of 2012, a number of organizational changes have been implemented. Examples include that a new executive body, NHS England, now has the main responsibility for healthcare provisions; that new mechanisms for the commissioning of services have been introduced; that the National Institute for Health and Care Excellence (NICE), which provides clinical guidance, has had its remit expanded to also include adult social care; and that a new agency for public health has been formed. Many other relevant organizational changes have also been made. The healthcare reform is to a large extent, intended to improve health outcomes, improve efficiency and meet health challenges for the future.

Quality improvement is of utmost importance and is driven forward not only by the government but also, to some extent, by interest groups and public pressure. Most of the current work on quality improvement originally stems from the 2008 report, High Quality Care For All – NHS Next State Review, led by Lord Darzi. The report discussed quality primarily in terms of effectiveness, safety and patient experiences. The NHS Outcomes Framework was later developed to define quality in outcomes and processes and to hold NHS England accountable for its quality as well as for upholding essential standards. In addition the National Quality Board has produced guidelines on quality, and a large number of other specific initiatives exist as well. Quality is sometimes coupled with monetary incentives, for instance in the Quality and Outcomes Framework (QOF) for general practitioners (GPs).

There are a number of public actors, including the regulators Monitor and the Care Quality Commission (CQC), present in the healthcare quality improvement system. While Monitor is the regulator that mostly focuses on management and efficiency, the CQC investigates clinical performance and excellence. Public Health England instead works with a more broad approach including the promotion of a healthy life style. However, the main responsibility for public health now lies with local authorities. NICE is not a regulator, a fact that often is brought forward as important, but sets quality standards, formulates guidelines and makes recommendations for indicators used for measurements. The commissioners on local, regional and national levels including the Clinical Commissioning Groups (CCGs) and NHS England are of importance to put pressure on quality improvements in the services they commission.

Measurements of healthcare performance are clearly important to increase quality and a well-organized infrastructure is in place for this. A multitude of measurements are made including audits, patient-reported outcomes measurements, surveys, measurements on procedures, drug use and outcomes, hospital episodes statistics etc. Data sources may include patients, GP practices, hospitals as well as other sources. The data is used for many purposes including research, funding decisions, regulation, to monitor safety and essential standards, to enable public choice and for policy decisions. Some anonymized data is published openly while data for research may be included in clinical quality registers or data-

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bases. Interestingly, some data for research is provided at commercial rates to companies and academic scientists.

The further development of advanced electronic data collection systems, the implementation of interoperable integrated personal electronic health records, and new devices to input data will most likely enable data collection to become qualitatively better and also more efficient in the future. It should be pointed out that while the description here is focused on national efforts, very advanced systems are used locally in some trusts.

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Sammanfattning

Ansvaret för sjukvården i Storbritannien är delat mellan England, Wales, Nordirland och Skottland. Därför gäller diskussionen i detta dokument endast England om inte annat anges. Den engelska sjukvården befinner sig i ett förändringsskede och som ett resultat av den stora hälsovårdsreformen 2012, har ett antal organisatoriska förändringar nyligen ge- nomförts. Bland annat har det löpande ansvaret för vården flyttats till en ny myndighet, NHS England; nya strukturer och mekanismer för upphandling av vårdtjänster har införts;

National Institute for Health and Care Excellence (NICE), som ger klinisk vägledning och formulerar standarder har fått sitt uppdrag utvidgat till att även omfatta sociala frågor; och en ny folkhälsomyndighet har bildats. Andra betydelsefulla organisatoriska förändringar har också genomförts. Hälsovårdsreformen syftar till stor del till förbättrade vårdresultat, ökad effektivitet och att möta framtida hälsorelaterade utmaningar.

Kvalitetsförbättring inom vården ses som ytterst viktigt och drivs framåt av regeringen men också i viss mån av intresseorganisationer och allmänheten. Större delen av det på- gående kvalitetsförbättringsarbetet har sin grund i en rapport från 2008, High Quality Care For All – NHS Next State Review, som leddes av Lord Darzi. I rapporten diskuteras kvalitet främst i termer av effektivitet, säkerhet och patientupplevelser. I ett senare led ut- vecklades NHS Outcomes Framework för att definiera kvalitet i form av resultat och processer, för att hålla NHS England ansvarigt för kvaliteten, samt för att upprätthålla essenti- ella standarder. National Quality Board, som fungerat som rådgivande instans för hälsode- partementet, har utarbetat övergripande riktlinjer för kvalitet, och ett stort antal andra kon- kreta initiativ finns också. Vårdkvalitet är ibland kopplad till finansiella incitament, till exempel i Quality and Outcomes Framework (QOF) för primärvården.

Ett antal offentliga aktörer, inklusive de två regulatoriska myndigheterna Monitor och Care Quality Commission (CQC), finns inom kvalitetssystemet för vården. Medan Monitor är fokuserat på förvaltning och effektivitet, undersöker CQC kliniska prestationer och kvalitet. Folkhälsomyndigheten Public Health England arbetar med ett bredare angreppssätt inklusive främjandet av en hälsosam livsstil. Samtidigt ligger huvudansvaret för folkhälsa nu till stor del på lokal nivå. NICE är inte en reglerande instans, något som ofta betonas, men sätter kliniska normer och riktlinjer samt ger rekommendationer om användningen av indikatorer för mätningar. De vårdupphandlande myndigheterna inklusive Clinical Com- missioning Groups (CCGs) och NHS England är betydelsefulla för att stimulera till kvali- tetsförbättringar inom de tjänster de upphandlat.

Mätningar av vårdresultat och processer är tydligt betydelsefulla för att öka kvaliteten, och en relativt välorganiserad infrastruktur finns på plats för detta. En stor mängd mätningar görs, bland annat i form av utvärderingar, patientrapporter, enkäter, processmätningar, läkemedelsanvändningsmätningar, sjukvårdsepisoder m.m. Uppgiftslämnare kan exempel- vis vara patienter, allmänläkarkliniker eller sjukhus. Uppgifterna används för många än- damål inklusive för forskning, för regulatoriska frågor, för övervakning av säkerhet och att grundläggande standarder uppnås, för att ge allmänheten valmöjligheter och som underlag för finansieringsbeslut eller policy. Alltmer data publiceras öppet medan forskningsdata kan inkluderas i kvalitetsregister eller databaser. Intressant nog förmedlas vissa forskningsdata till företag och forskare på marknadsmässiga villkor.

Vidareutvecklingen av avancerade IT-system för datainsamling, införandet av interope- rabla integrerade elektroniska patientjournaler och nya lösningar för datainmatning

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kommer sannolikt att bidra till att datainsamlingen blir kvalitativt bättre och ännu effekti- vare i framtiden. Det bör påpekas att medan beskrivningen här är primärt inriktad på nat- ionella insatser, använder man sig lokalt vid vissa sjukhus av mycket avancerade system.

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1 The English healthcare system

1.1 Introduction

In the UK, 9.6 percent of GDP was used for health in 2010. This was approximately 0.1 percent above the OECD average and corresponded to a per capita expenditure of Intl.

$3480.^1,2 All legal residents and British nationals are entitled to cover from the National Health Service (NHS). In addition, EEA residents are entitled to some healthcare as are residents and citizens from countries with joint agreements. Emergency treatments are without charge to anyone.³

The responsibility of the healthcare system in the United Kingdom (UK) is devolved which means that the responsibilities lies on the level of the individual countries; England, Scot- land, Wales and Northern Ireland. The different parts of the union, and maybe in particular England and Scotland, have different policies and priorities. However, in all cases healthcare is funded through public taxes although private health insurers and providers are present. The private sector is largely used to increase the NHS’ capacity and provide for those with private health insurance or who are willing to pay directly. The frequency of individuals with private health insurances in the UK is approximately 11.2 percent overall (2003) and is highest in the London area and in the southeast of England.⁴

The NHS in England has been reformed a number of times and a new healthcare reform bill was approved in Parliament in March 2012.

1.2 The National Health Service in England

The NHS was founded in 1948 and is maybe the largest publicly funded healthcare provider in the world.⁵ It employs more than 1.7 million people of which nearly 50 percent are clinically qualified. This makes the organization one of the world’s largest in terms of em- ployees. The turnover of patients is approximately 1 million every 36 hours and the NHS budget was approximately £108.9 billion in 2012/13.

The NHS is currently undergoing a major reform and many changes were implemented on April 1^st 2013. Up until now the NHS has contained a number of Primacy Care Trusts (PCTs) and Strategic Health Authorities (SHAs) that were responsible for the purchase and performance of care. Briefly, this involved the ten SHAs coordinating the activities of local trusts and other bodies, while 152 PCTs were responsible for the purchase and provision of healthcare. Primary care was largely provided by general practitioners (GPs) and teams in health centers while the responsibility for social care services was shared between the NHS and local authorities.⁶ Hospitals are largely publicly owned and may have independent trust status.

In the new system, resulting from of one of the most extensive reorganizations of the Eng- lish NHS ever, the PCTs and SHAs were abolished and funds transferred to Clinical Commission Groups (CCGs) run by GPs and other medical staff. A number of agencies

1 http://www.oecd.org/unitedstates/BriefingNoteUSA2012.pdf

2 http://www.who.int/countries/gbr/en/

3 http://www.ukba.homeoffice.gov.uk/visas-immigration/while-in-uk/rightsandresponsibilities/healthcare/

4 http://www.euro.who.int/__data/assets/pdf_file/0007/98422/Private_Medical_Insurance_UK.pdf

5 http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx

6 https://www.gov.uk/government/policies/making-sure-health-and-social-care-services-work-together

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oversee the system. Some agencies have been be abolished, reformed or have had their powers and responsibilities transferred to other agencies of which some are new. A larger degree of competition and participation of private organizations is anticipated in the future.

The responsibilities and organization of healthcare, public health and social care has changed and the responsibility for public health and social care now lies primarily with local authorities. This text primarily discusses healthcare issues although some information on public health and social care is provided as well. Some of the new reforms and extracts from the NHS reform history are briefly described below.

1.3 Reform of the National Health Service in England

The NHS has been reformed a number of times⁷ and no text about the English healthcare system would be complete without mentioning the controversial Health and Social Care Act of 2012 which gained royal assent on March 27th 2012.⁸ The bill was, at least to a large extent, intended as a way to allow the health service to improve health outcomes, become more efficient and meet challenges for the future. Such challenges include for instance demographic changes with an increased proportion of elderly people, costs for new drugs and treatments, and destructive lifestyle habits (such as obesity, smoking, and lack of exercise) and related diseases. The origin of the reform was largely the white paper

“Equity and Excellence: Liberating the NHS”⁹ and the implementation plan “Liberating the NHS: legislative framework and next steps” (2010).¹⁰

The reform has resulted in a large reorganization of the NHS in England, and is partly designed to increase patient choice, competition and greater involvement from the private sector and charities. NHS in England is not anymore under the direct control of the De- partment of Health but managed by a new agency entitled NHS England (previously NHS Commissioning Board). NHS England is, however, accountable for NHS performance on the goals set by government.

As mentioned in the previous chapter, the NHS until recently contained a number of Pri- mary Care Trusts (PCTs) and Strategic Health Authorities (SHAs) that were responsible for the purchase and performance of healthcare. A very important part of the reform is that these have now been abolished and funds transferred to 212 Clinical Commission Groups (CCGs) usually run by GPs and other medical staff. The new NHS England will be responsible for the commissioning of healthcare services via CCGs as well as direct commissioning of some services. An overview¹¹ of the overarching principles for healthcare is shown in fig 1. Social care is commissioned separately by local governments and not described here.

NHS services will be opened up for more competition from providers that meet NHS standards on price, quality and safety. A number of agencies oversee the system and promote healthcare, social care, and public health. The Care Quality Commission (CQC) is the national regulator of health and social care in England. This includes GP practices, hospitals and all private providers of health and social care. The remit of the other regulator, MONITOR, has been changed and now includes licensing of providers of NHS-funded services, prevention of anti-competitive behaviors that are against the interests of patients,

7 http://www.nhs.uk/Tools/Pages/NHSTimeline.aspx, http://nhstimeline.nuffieldtrust.org.uk

8 http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted

9 https://www.gov.uk/government/publications/liberating-the-nhs-white-paper

10 https://www.gov.uk/government/publications/the-governments-response-to-the-2010-consultation-on-nhs- reform

11 http://www.bbc.co.uk/news/health-12177084

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support of the continuity of services, enabling of integrated care, and regulation of prices for NHS-funded services.¹² Measurements and audits are likely to become even more important in the future, not least due to a larger numbers of healthcare providers.

As previously mentioned, some agencies have been abolished, reformed or have had their powers and responsibilities transferred (see also chapter 1.3.1). New organizations, including the independent consumer champion for health and social care, Healthwatch Eng- land,¹³ and Public Health England (PHE)¹⁴ came into being on April 1^st, 2013. The purpose of PHE is to protect and improve the nation’s health and wellbeing, and to reduce inequalities. A change resulting from the reform is also that local authorities will take on most of the responsibility for public health. These are expected to work closely with health and care providers, communities, agencies, and the public, not least to tackle challenges related to destructive lifestyles.

Fig. 1: Main principles concerning oversight and flow of funds for healthcare before and after the implementation of the reform. Principles related to public health and social care, are not included in the figure.

Source: Adapted from BBC original.

12 http://www.monitor-nhsft.gov.uk/home/news-events-publications/latest-press-releases/monitor-emphasises- continuity-regulatory-regime-

13 Healthwatch England

14 http://healthandcare.dh.gov.uk/category/public-health/phe/

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It is expected that most hospitals and other NHS trusts will become foundation trusts by 2016.¹⁵ Fig 2 below shows an outline of the new healthcare system.

Fig. 2 Overview over the new healthcare landscape after April 1st, 2013.

The NHS Commissioning Board has been renamed and is now called NHS England.

Source: Department of Health.

1.3.1 Summary of some of the new organizational structures relating to quality issues in healthcare

The healthcare reform resulted in a number of organizational changes directly or indirectly related to quality. Some of the conditions after the implementation of the reform are listed below. A number of the organizations are described further in later chapters.

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An independent agency, NHS England, was established. The agency is responsible for the allocation of funds to CCGs and also directly commissions some services.

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The Care Quality Commission (CQC) continues to be the statutory regulator for the quality of health and social care in England and drives quality improvements. Among its main tasks is registering and monitoring of services and making sure people’s views and experiences affect the regulatory mission. It will also be an authoritative voice on the state of English healthcare. CQC and Monitor will collaborate on some regulatory issues.

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MONITOR is the regulator for all NHS-funded care and focusses on value for money in the provision of services. Monitor and the CQC collaborate on some regulatory issues.

15 http://www.nhs.uk/NHSEngland/thenhs/about/Pages/nhsstructure.aspx

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The National Institute for Health and Care Excellence (NICE) sets standards across health, public health, and social care. Social care is a new area of responsibility for NICE.

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All NHS Trusts will eventually become foundation trusts and thereby become free from direct central direction and control.

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The NHS Trust Development Authority was established and will oversee the performance of NHS Trusts and support them to provide high quality services and eventually become foundation trusts.

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The newly formed Public Health England provides advice and specialist services to reduce inequalities and increase public health. The responsibility for public health will mostly lie with local authorities.

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Health Education England provides leadership for professional education and training and work with the allocation of resources.

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Healthwatch is responsible for patient inputs on healthcare, both nationally and locally.

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Local Health and Wellbeing boards16 were established to provide a venue where key leaders from the health and care system jointly can work to improve the health and wellbeing of their local population and reduce health inequalities.

16 http://healthandcare.dh.gov.uk/hwb-guide/

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2 The debate on quality in healthcare

During its long history, the NHS has been criticized and partly revamped a number of times.¹⁷ The criticism has over time included many issues such as long waiting times and regional inequalities with regard to access to treatments and new medicines.¹⁸ A relatively recent issue that has led to considerable debate is the cancer survival rate, which appears to be lower in England than in countries such as Canada, Australia, Sweden and Norway.^19,20 Not least has the importance of early diagnosis been highlighted.

It cannot be said that quality in healthcare has been a major driving force in the public debate in general. Most of the driving forces for improved quality in the healthcare system rather come from the government, authorities, and the healthcare system itself. Scandals, however, such as the heart scandal at the Bristol Royal Infirmary in the 1990s²¹ and the maltreatment issues at the Mid Staffordshire NHS Foundation Trust have sometimes led to public outcry. The Mid Staffordshire scandal led to the inquiry led by Robert Francis QC²² that included a large number of recommendations. Health Secretary Jeremy Hunt has stated that the events at Mid Staffordshire Hospital and other failings were “a shocking betrayal of NHS founding values”.

2.1 Towards a quality framework

Much of the recent work on healthcare quality originally stems from the report “High Quality Care for All”,²³ which was a result of the NHS Next Stage Review led by Lord Darzi. Although now incorporated in and replaced by the NHS Outcomes Framework, the Darzi framework was an important cornerstone. In it, quality was defined in three major dimensions namely:

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Clinical effectiveness,

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Safety,

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Patient experience.

In the report, a seven-step quality framework was defined and is now being used as a guiding principle. The steps are briefly described and commented on below. A number of initiatives and organizations are described further in the coming chapters.

Bringing clarity to quality – Clear definitions are needed to know what high quality care is. In this, NICE (see chapter 4.1.4) plays a crucial role by defining quality standards.

These may often be seen as gold standards to strive towards.

Measure and publish quality – To drive quality improvements there is a need for relevant and correct information on the quality of care, and this information should be publicly available. The NHS Outcomes Framework (see chapter 3.2) defines national quality goals and will be used to hold NHS England accountable. NHS England will develop a frame-

17 http://nhstimeline.nuffieldtrust.org.uk/

18 http://news.bbc.co.uk/2/hi/programmes/panorama/7563701.stm

19 http://www.dailymail.co.uk/health/article-2001248/UK-cancer-survival-rates-worst-Western-world.html

20 http://www.kingsfund.org.uk/sites/files/kf/How-to-improve-cancer-survival-Explaining-England-poor-rates- Kings-Fund-June-2011.pdf

21 http://en.wikipedia.org/wiki/Bristol_heart_scandal

22 http://www.midstaffspublicinquiry.com/

23 http://www.nhshistory.net/darzifinal.pdf

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work to hold commissioning groups accountable. This framework will also draw on NICE quality standards. Other outcomes frameworks for public health and social care exist as well. Finally, clinical audits and other quality indicators should be used by providers to drive quality improvements.

Reward quality – Financial incentives should be used to encourage and drive quality im- provements. Examples of such mechanisms are the Quality and Outcomes Framework (QOF) and the Commissioning for Quality and Innovation (CQUIN) payment framework²⁴ that both are used by NHS England. Other types of quality premiums, for instance in the Clinical Commissioning Group Outcomes Indicator Set,²⁵ will be used to reward improvements. Monitor may use quality performance in its payment system.

Leadership for quality – Leadership is essential to raise quality standards. In this, the National Quality Board (NQB) as well as other boards and clinical networks on different levels are important.

Innovation for quality – Innovation is essential to drive quality in healthcare. In this, many initiatives within and outside the NHS are important. Examples are the Academic Health Science Networks and centers that bring together actors from universities, the NHS, public health, social care, and industry. The National Institute for Health Research (NIHR) is likely to be of central importance as are NICE technology appraisal programs.

Safeguard quality – Essential standards of safety and quality must be maintained. Not least is it important to maintain and improve standards for the clinical professions.

2.2 The National Quality Board

The National Quality Board (NQB) is a high level board formed to encourage the delivery of high quality healthcare by the NHS, and also at the interface between healthcare and social care. A primary function of the NQB is to give advice to the Secretary of State for Health. Representation on the NQB includes a number of high-level functions within the DH and NHS England, a number of agencies (e.g. NICE, Monitor, CQC), experts as well as lay members. Although changes in the NQB remit are possible as a result of the reform, key areas of responsibility have been:

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ensuring the overall alignment of the systems for managing and improving quality,

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delivering on specific technical responsibilities, including overseeing work to improve quality indicators,

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assuming a wider leadership responsibility for driving the quality agenda and acting as a powerhouse for change,

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contributing to NICE quality standards, quality accounts, patient experience, accredita- tion and clinical audit policy areas.

As one result of the failings at the Mid Staffordshire Foundation trust, NQB was in 2008 asked by the Secretary of State for Health to conduct a review into systems and processes in place for safeguarding healthcare quality. The board subsequently set out roles and responsibilities for safeguarding quality across the system. The main findings can be found below:

24 http://www.institute.nhs.uk/commissioning/pct_portal/cquin.html

25 http://www.nice.org.uk/aboutnice/cof/cof.jsp

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Ensuring that patients receive high quality care is an inherently complex and fragile operation.

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Robust systems and processes to monitor, manage performance and regulate the quality of care provided to patients are essential. However, the success of these is almost entirely dependent on the values and behaviors of staff and organizations working throughout the system.

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The NHS needs to embrace a culture of open and honest cooperation where individuals and organizations are transparent about the quality of care being provided to patients, and the whole system works collaboratively to share information, address concerns and raise standards.

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The quality of care provided to patients should never be compromised by the ambitions or management pressures of the organizations commissioning or providing services.

Organizations need to look beyond their organizational boundaries and concerns about their autonomy, and always consider the needs of the patient first.

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Listening to patient and service users’ experiences of care and concerns is a key part of the early warning system. However, relying on patients alone to hold the system to account, even with the increasing information that is being made available publicly, cannot be sufficient. There will always be an asymmetry of information and understanding on the part of patients compared with others who work in or with the system.

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There must be absolute clarity about the different roles and responsibilities for quality of individuals and organizations across the system.

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NHS staff and clinical teams are the first line of defense in preventing serious failure in the NHS. However, ultimate responsibility for safeguarding quality rests with the organization providing care through its board or equivalent.

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No system can be 100 percent failsafe and where a failure does occur there needs to be a system‐wide response with three key objectives:

– safeguarding patients,

– ensuring the continued provision of services to the population,

– securing rapid improvements of the quality of care at the failing provider.

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A single organization should ‘hold the ring’ on this response to ensure that action across the system is swift and remains aligned and coordinated at all times.

In January 2013, NQB published the final report “Quality in the new health system ‐ Maintaining and improving quality from April 2013”.²⁶

2.3 The new information strategy

The use of information is central to drive healthcare quality and in 2012 the Department of Health published a strategy²⁷ for how the NHS should expand and improve the use of information and increase transparency, public accountability and support patient choice.

The scope of the strategy is broad and sets out new ways information can be collected and

26 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/127420/Final-NQB-report-v4- 160113.pdf.pdf

27 http://informationstrategy.dh.gov.uk

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used for patients, carers, clinical professionals, managers, commissioners, regulators, and others. An important point is to avoid unnecessary duplication of work and to create a culture of transparency of information. One necessary condition for the implementation of the strategy is the ability of information to flow between systems. This may be partly implemented by open interoperable standards rather than the use of the same technology throughout the whole system.

Central to the strategy is how information can be used in a more integrated way and for multiple purposes. A number of the measures relate to quality, whether it concerns patient experiences, patient choice, accessibility, clinical practice, outcomes or the ability to eval- uate hospitals and other caregivers. The importance of recording clinical data at the patients’ first contact with the clinical system, and of electronic health records (EHR), is highlighted. An ambition is to let EHRs improve care, inform research and enable improved measurements of quality. Patients are supposed to have access their GP EHR records by 2015. In this, the unique NHS numbers are believed to be important as identifiers.

With regard to research, the possibility to link different data while protecting the integrity of individuals is mentioned.

Other examples of highlighted areas relevant to this paper are information to be able to monitor how well services work and thereby make choices, and the use and sharing of anonymized information to enable the improvement of services. This type of population data should be important for service providers as well as commissioners and researchers.

Furthermore, the number of mistakes relating to data is likely to be reduced when electronic systems have been implemented fully. Such systems may also include telehealth and mHealth solutions.

The Information Governance Review²⁸ which was published in March 2013 should also be mentioned in this context. The review which was chaired by Dame Fiona Caldicott con- cluded that the sharing of anonymized patient records and data across health, public health and social care services is necessary and permissible to support the provisions of integrated care. This should of course be subject to appropriate safeguards and patient objections should be respected.

28https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/192572/2900774_InfoGoverna nce_accv2.pdf

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3 Initiatives for better outcomes and increased quality in healthcare

Many countries including England have moved the governance model from a focus on access and cost to one on outcomes. Because of this, quality and outcomes measurements have become more important in order to identify performers with low outcomes, make funding decisions, identify best practices, enable outcomes research, and make policy decisions.

Healthcare quality, outcomes, and performance can be measured in a multitude of ways and for many purposes. Measurements could for instance consider adherence to clinical standards, procedures, dosages of medications, outcomes, cleanliness of the wards, prevalence of hospital-acquired infections or patient and staff experiences. It could also include issues related to management, economic performance, adherence to laws and regulations, staffing, etc. According to the Department of Health (DH), quality is a guiding principle for all NHS activities. However, obviously measurements can be made on different aggre- gation levels, for different purposes, and for authorities on all levels (national, regional and local).

The English frameworks for quality and outcomes include a very large number of ele- ments. One important factor is clear national quality standards in healthcare. In this, the work done by NICE is of particular importance, not least for the regulators CQC and Monitor.

Measurements are also made to enable public insight and individual choice. The NHS Choices website is a major health website and provides comprehensive health information to enable individuals to make choices regarding health, lifestyle and healthcare providers.

The website can also be used to find NHS services. The information provided draws on resources such as the NHS Evidence website,²⁹ the Health and Social Care Information Centre,³⁰ the CQC,³¹ and others.

In order to increase accountability to the public and to be a driving force underlying quality improvement, Quality Accounts have been introduced. These are annual reports produced by all providers of NHS services, on the quality of their services. The publication of Qual- ity Accounts is mandatory. The content may however vary somewhat from year to year depending on specific demands.

3.1 NHS Improving Quality and the Quality, Innovation, Productivity and Prevention program

It is evident that increased quality cannot be delivered through top-down targets alone but must be achieved by focusing on outcomes and the devolution of power and accountability to care providers. This is also, according to the DH, a driving force underlying the changes that the NHS presently is undergoing.

The NHS needs to make savings because of growing demands, an ageing population and none or only small increases in funds for the foreseeable future. The Quality, Innovation,

29 http://www.evidence.nhs.uk/nhs-evidence-content/journals-and-databases

30 http://www.ic.nhs.uk/

31 http://www.cqc.org.uk/

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Productivity and Prevention (QIPP)³² program, previously hosted by the now closed NHS Institute for Innovation and Improvement, is a DH strategy that aims to improve the quality and delivery of NHS care while reducing costs to improve productivity by four percent a year from 2010/11 to 2014/15. It involves all NHS staff, patients, clinicians and charities.

A number of quality-related tools including case studies are available through the NHS improvement/QIPP website.

The NHS Institute for Innovation and Improvement focused on practical service improvement and had extensive experience in clinical patient pathway redesign in different disease areas. On April 1^st 2013 it was transferred to NHS Improving Quality (NHS IQ) hosted by NHS England. NHS IQ is intended to become a driving force for improvement across the NHS in England, and integrates the knowledge, expertise and experience from across the healthcare system. NHS IQ’s priorities are aligned to the five domains of the NHS Out- comes Framework (see below).

3.2 The NHS Outcomes Framework

The NHS Outcomes Framework was developed in 2010 to provide an overview of how well the NHS is performing, to provide an accountability mechanism, and to act as a catalyst for the improvement of quality. The purpose of the framework is to:

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provide a national level overview of how well the NHS is performing,

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provide an accountability mechanism between the Secretary of State for Health and NHS England,

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act as a catalyst for driving up quality throughout the NHS.

The indicators used are organized in five principal domains (figure 3) related to areas identified in the NHS Next Stage Review.³³ The domains can be seen as national outcomes for the NHS to strive towards and can also be organized according to the main areas of patient experiences, effectiveness and safety.

32 http://www.improvement.nhs.uk/Default.aspx?alias=www.improvement.nhs.uk/qipp

33 http://www.official-documents.gov.uk/document/cm74/7432/7432.pdf

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Fig. 3 The five domains of the NHS Outcomes Framework.

Source: NHS.

Group 1: Effectiveness

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Preventing people from dying prematurely (domain 1)

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Enhancing quality of life for people with long-term conditions (domain 2)

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Helping people to recover from episodes of ill health or following injury (domain 3) Group 2: Patient experience

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Ensuring people have a positive experience of care (domain 4) Group 3: Safety

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Treating and caring for people in a safe environment and protecting them from avoidable harm (domain 5)

The framework 2013 to 2014³⁴ sets out the outcomes that will be used to hold NHS Eng- land to account for improvements in health outcomes. It contains a large number of issues and indicators that either are already being used, are being developed or where development is difficult. It also outlines what types of regional measurements (local, regional, national, international etc.) that are needed.

In addition to the NHS Outcomes Framework there are also frameworks for public health³⁵ and adult social care³⁶ that have separate lines of funding and accountability. Some actors

34 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/127106/121109-NHS- Outcomes-Framework-2013-14.pdf.pdf

35 https://www.gov.uk/government/publications/healthy-lives-healthy-people-improving-outcomes-and- supporting-transparency

36 https://www.gov.uk/government/publications/the-adult-social-care-outcomes-framework-2013-to-2014

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believe that there is a risk that this “three-way split” will lead to an increased fragmenta- tion of care.

3.3 The Quality and Outcomes Framework

The Quality and Outcomes Framework³⁷ (QOF) was set up in 2004 and is a voluntary incentive program for all GP practices in the UK. There are however variations in the QOF agreements between England, Scotland, Wales and Northern Ireland. The QOF gives an indication of the overall achievements of a practice through a points system linked to a set of evidence-based quality indicators. A higher score will result in a higher financial reward for the practice. However, the final payment is adjusted to take account of the prevalence of specific diseases. NICE has responsibility for developing QOF indicators, which are subject to change over time.

The QOF contains four main components, known as domains. Each of these consists of a set of measures (indicators) against which practices score points depending on their level of achievement. For 2013/14, a number of changes to QOF will be introduced that relate to clinical, administrative and organizational issues.^38,39,40 A debate on the new QOF structure including the workload for practitioners took place and the parties are not in accord.^41,42,43 The new domain structure is as follows:

The clinical domain

•

The domain contains indicators across different clinical areas such as coronary heart disease, heart failure and hypertension.

The public health domain

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The domain contains indicators across clinical and health improvement areas such as smoking and obesity. An additional services subdomain contains indicators relating to cervical screening, child health surveillance, maternity services and contraceptive services.

The patient experience domain

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The domain contains one indicator relating to the length of consultations.

The quality and productivity domain

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The domain contains indicators aimed at securing a more efficient use of NHS resources through improvements in the quality of primary care by rewarding reducing emergency admissions, reducing hospital outpatient referrals and reducing avoidable accident and emergency attendances.

As in most other cases, the data is largely or completely collected by the Health and Social Care Information Centre (HSCIC).

37 http://www.ic.nhs.uk/qof

38 http://www.gp-update.co.uk/Latest-Updates/Summary-of-QoF-changes-for-2012-13

39 http://www.pcc-cic.org.uk/article/key-changes-qof-consultation-gp-contract-201314

40 http://www.nice.org.uk/media/1E3/79/QOFACJune12SummaryRecommendations.pdf

41 http://www.commissioning.gp/news/article/671/significant-risks-associated-with-proposed-qof-changes/17/

42 http://bma.org.uk/practical-support-at-work/contracts/independent-contractors/qof-guidance

43 http://www.bmj.com/content/346/bmj.f1942.pdf%2Bhtml

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4 Roles and responsibilities

Professionals and organizations, from frontline clinicians to the Secretary of Health all have a responsibility for the operation and quality of the NHS healthcare system. We cannot describe all of the relevant organizations and groups here and will therefore only men- tion some of the most important.

4.1 Responsibilities for performance, guidance, regulations, surveillance and policy

4.1.1 The political and departmental level

The Secretary of Health has the overall responsibility for the provision of healthcare to the citizens and other residents. The Secretary has a number of advisory, counseling, and departmental functions to support him or her. In addition some responsibilities, such as health research, may be joint between departments.

The Department of Health

The DH is ultimately responsible for healthcare and healthcare quality in England. The Secretary of State for Health has the responsibility for healthcare and is accountable to Parliament for the provision of healthcare services. He or she also has a duty to ensure continuous improvements in the quality of services.

Overall, the DH is responsible for ensuring that the healthcare system is able to deliver quality care as well as being cost effective. The DH defines objectives for NHS England each year, which includes objectives for quality improvements under the NHS Outcomes Framework as well under other frameworks. It also sets out essential standards for quality and safety in legislation. The CQC uses these standards when registering providers.

The DH, on an overarching systems level, funds the different national health bodies so they can perform their functions as intended. It should be noted that several previous functions, and staff, of the DH were transferred to NHS England on April 1^st 2013.

4.1.2 Commissioning – NHS England and Clinical Commissioning Groups

Commissioning of healthcare is, since April 1^st 2013, made by the NHS England and Clinical Commissioning Groups (CCG). One central aspect is that the CCGs must make certain that commissioned services adhere to decided quality standards and that providers are registered with the Care Quality Commission (CQC, see below). Work to improve quality should be included in the contracts. NHS England will support and monitor the CCGs in their commissioning of services, and promote quality improvements in the services the agency commissions directly. NHS England has the responsibility for the direct commissioning of primary care services, dental services and some specialist services.

The formation of NHS England was a result of the English healthcare reform. The new agency, which is an executive non-departmental independent body, was established in October 2012 as the NHS Commissioning Board. It took on its full statutory responsibilities on April 1^st 2013. NHS England has been charged with the establishment and running of the NHS in England, including the new commissioning landscape and relations. The organization has agreed on the configuration and practices of 212 CCGs covering all of England. Among other things, NHS England has developed a new NHS Commissioning

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Assembly, which brings together leaders from all clinical commissioning groups and NHS England. The assembly will:

•

create shared leadership at the national level fostering the sense of joint responsibility,

•

be the infrastructure through which the CCGs and NHS England jointly can develop national strategies,

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be a mechanism through which CCGs can build consensus on key issues,

•

be a learning network,

•

facilitate communication between CCG leaders at the national level.

On April 1^st 2013, NHS England took up many of the functions of the Primary Care Trusts in relation to the commissioning of primary care services as well as some of the national functions of the Department of Health. Some of the staff previously working directly for the Department of Health will in the future work for NHS England.

The new arrangements involve a single operating model for the commissioning of primary care services, which up until now has been done in different manners by PCTs. Some of the benefits are believed to be:

•

a greater consistency and fairness in access and provision for patients, without unjustifiable variations in services,

•

better health outcomes for patients as primary care clinicians are empowered to focus on delivering high quality, clinically-effective, evidence-based care,

•

greater efficiencies in the delivery of primary care health services through the introduction of standardized frameworks and operating procedures.

4.1.3 Regulatory bodies

A number of regulators including the Care Quality Commission (CQC), Monitor and professional regulators exist. Here, we will briefly explain the roles played by CQC and Mon- itor. Regulators of professions are important to set standards for competences and professional behaviors and also to ensure educational quality. Licensing of medical doctors and nurses is central to ensure quality of services.

The Care Quality Commission

The Care Quality Commission⁴⁴ (CQC) is an independent regulator of health and adult social care. It has a remit to ensure that only providers that have made a binding statement that they meet the essential standards of quality and safety,⁴⁵ and satisfy the registration process, provide care. CQC has powers of enforcement and takes action if services are unacceptably poor. In the current reorganization the powers of CQC have increased. CQC largely focuses on:

•

safety and safeguarding,

•

effectiveness and clinical outcomes,

•

experiences of people using the services.

44 http://www.cqc.org.uk/

45 http://www.cqc.org.uk/public/what-are-standards/national-standards

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CQC uses site visits, reviews, many routine datasets (including patient surveys) and clinical audits as tools to investigate services,⁴⁶ and monitor the providers against the required standards. National Clinical Audits (see chapter 6.1) are often defined as “a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change”. Hospitals, dental practices, ambulances, care homes, and other services are registered with CQC. From April 1^st 2013 this also includes primary medical care providers.

CQC works to identify best practices in the services they inspect and disseminate important and useful intelligence. Overall, CQC drives quality improvements in healthcare in many ways such as by:

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registering and monitoring services,

•

receiving input from people,

•

reporting on the state of care,

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working with strategic partners (including Monitor).

Healthwatch⁴⁷ will be part of CQC, as a central agency with 152 local branches that will act as a champion and spokesperson for the views of users of health and social care services.

Monitor

Monitor is the economic regulator for healthcare in England. Together with CQC it licenses providers and ensures continued access to healthcare. Monitor may vary the terms of a license to providers and take action if a provider breaches the terms of its license. The agency primarily promotes economy and management aspects of healthcare services.

Monitor has a number of important roles, including:

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enforce license conditions (governance),

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publish the national tariff, set prices and determine rules for payment,

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approve local variations from the national tariff,

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ensure essential services.

The licenses require that license holders hold a CQC registration if they provide a regu- lated activity. Monitor will be able to fine, order restitution or revoke licenses if rules are broken. If CQC decides that a provider is delivering substandard care and Monitor deter- mines that this is due to poor governance, the agency may impose additional measures.

Monitor will license all providers of NHS-funded care except NHS trusts that have not yet secured foundation trust status. Such trusts will be monitored by the NHS Trust Develop- ment Agency (TDA). The NHS TDA will be responsible for overseeing the performance of NHS Trusts including clinical quality. The authority will have the possibility to inter- vene or provide support if it has concerns about quality and can work together with other regulators and commissioners. Both Monitor and the NHS TDA will collaborate closely with the CQC on judgments of quality.

46 http://www.cqc.org.uk/how-we-work-clinicians-and-professionals/clinical-audits-measure-success

47 http://www.cqc.org.uk/public/about-us/partnerships-other-organisations/healthwatch

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4.1.4 Best practices and guidelines – The National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence⁴⁸ (NICE, previously the National Institute for Health and Clinical Excellence, National Institute for Clinical Excellence) is not a regulator but assesses best practices and provides guidance. From April 2013, its remit has been expanded to include social care, public health and healthcare.

NICE is an independent organization responsible for setting clinical guidelines and standards for public health, healthcare and social care. It assesses technologies, treatments, care methods and tools, and produces guidance and recommendations. It sets quality standards for good patient care and also advises and gives support on how its recommendations and standards can be implemented. When further research is needed, NICE may request research be commissioned and/or the setup of registries/databases. Guidance is provided in the following areas:

•

Public health (promotion of health and prevention of ill health).

•

Social care (adults and children, included from 2013).

•

Health technologies (including use of medicines, devices, diagnostics, and procedures).

•

Clinical practice (including guiding on appropriate treatments).

NICE provides guidance and other information in a number of ways including through its website and via NHS Evidence.⁴⁹ NHS Evidence is a resource, managed by NICE, that enables access to clinical and non-clinical evidence, as well as information on best practices, through a web-based portal.

The organization’s recommendations often have strong impacts. In most cases NICE pub- lishes positive recommendations. It is, however, mostly when NICE advises against something based on cost-effectiveness grounds that public attention is highest.

The importance of the recent inclusion of social care should not be underestimated as this is a huge increase in NICE’s remit. Furthermore, social care is largely the domain of local authorities that are not necessarily used for guidance of the kind that NICE provides.

Importantly, NICE also develops clinical and health improvement indicators for CCGs and for the Quality and Outcomes Framework (QOF) on behalf of NHS England. One ambition in the recent overhaul is that NICE’s appraisal processes should become faster.

4.1.5 Public Health England and other entities

Public Health England

Public Health England (PHE)⁵⁰ was established on April 1^st 2013 to protect and improve health and wellbeing and to reduce inequalities. At the same time, the responsibility for public health was transferred to local authorities. PHE provides expertise and support on public health issues to local authorities and the NHS. The Health Protection Agency as well as other entities were merged into Public Health England (PHE). Some public health issues, including the Public Health Observatories, are discussed further in chapter 5.2.

48 http://www.nice.org.uk/

49 http://www.evidence.nhs.uk

50 http://healthandcare.dh.gov.uk/category/public-health/phe/

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Other agencies

A number of other organizations and agencies are relevant for quality-related issues in the NHS. However, not all of these can be described here. The Health Services Ombudsman⁵¹ and Health Education England (HEE)⁵² are crucial for the quality and performance of healthcare in the country. While HEE is responsible for post-basic education, the ombudsman, who is independent of government, is central to investigate complaints from individuals regarding the NHS health services.

4.1.6 The individual level

Obviously, healthcare professionals should utilize the wealth of quality-related metrics from audits, patient feedback, peer review and other sources. This clearly applies to healthcare professionals irrespectively of whether they work in primary care, at hospitals or otherwise. Clinical leaders have a special responsibility to ensure that clinical governance is following rules and guidelines, to support staff, and to promote a quality-conscious culture. Furthermore the leadership of a provider organization is ultimately responsible for the quality of the delivered care. Formally, governors of NHS Foundation Trusts have an overarching responsibility to hold the trust leadership to account for quality and performance.

4.2 Quality surveillance groups

In order for the actors in the health and care system to share information and intelligence on quality, Quality Surveillance Groups (QSGs)⁵³ have been formed and will work as fo- rums for local and regional healthcare economies. The initiative is not intended to increase bureaucracy and groups are in practical terms already in place in some cases. The QSGs will work at two levels:

•

Locally – following the 27 NHS England Local Area Teams.

•

Regionally – following the four regions of NHS England.

Members of the local QSGs may include all commissioners in the area, the NHS TDA, the local education and training board, the local Healthwatch, PHE centres, Monitor, CQC and representatives from local authorities. Providers are not part of the QSGs. On the regional level, membership will mostly be mirrored but with regional centers instead of local, and with professional regulators such as the General Medical Council (GMC) and the Nursing

& Midwifery Council (NMC) if they wish to participate.

NHS England will provide support and facilitate the work of the regional and local QSGs in a number of ways. The agency will ensure that all parties who need to be involved are involved, provide records and protocols, and ensure that a clear understanding exists of how the groups will consider providers and facilitate sharing of information.

Through various mechanisms, QSGs will provide surveillance of quality in its region or local area and take action when needed. Such occurrences may involve the actions by different authorities and actors and it is necessary to recognize the responsibilities and man- dates of the individual members of the QSGs. At any time when action is needed, one

51 http://www.ombudsman.org.uk/

52 http://hee.nhs.uk/

53 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/156277/Establishing-Quality- Surveillance-Groups.pdf.pdf

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party should “hold the ring” in the collective discussions. It is seen as important that swift action can be taken when necessary.

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5 Public health

Public health issues include for instance anticipated demographic changes, with an increased fraction of elderly, and an increased prevalence of life style-related diseases such as diabetes, heart conditions, liver disease, lung cancer, and chronic obstructive lung disease. As a result of the healthcare reform, the responsibility for public health now largely lies with local authorities. The executive agency called Public Health England (PHE, see also chapter 4.1.5) started its operations on April 1st 2013, is responsible for the “protection and improvement of the nation's health to support healthier choices”, and will work with local and national governments, industry and the NHS. At the same time as the PHE was formed, the Health Protection Agency was merged into the new organization. England has, since previously, an active public health program.

5.1 Public Health Outcomes Framework

Public health issues are complex and efforts to improve the situation involve an integrated approach where public and private local, regional and national organizations cooperate in various ways. Furthermore, an alignment of frameworks dealing with healthcare, social care and public health is likely to be important. Changes do not generally happen overnight but may take many years. The efforts to reduce smoking that have been ongoing for dec- ades is a good illustration of this. The Public Health Outcomes Framework was initiated to work towards the desired outcomes for public health and to develop indicators of how these outcomes can be measured. The focus is on life expectancy and how differences in life expectancy can be reduced (e.g. between communities or socioeconomic groups). The framework involves many indicators, many of which are focused on:

•

health protection (e.g. immunization),

•

health improvement (e.g. reduced smoking),

•

wider determinants of health (e.g. deprivation),

•

healthcare, public health and preventing premature mortality.

Data on many of the indicators is available through the Public Health Outcomes Frame- work Data Tool. The data is collated by the Public Health Observatories of England. The need to improve and develop the information and indicators is recognized and will con- tinue over years to come. The intention is to expand the number of indicators and range of equalities breakdowns.

5.2 Public Health Observatories

The 12 Public Health Observatories (PHO)⁵⁴ are distributed across England, Scotland, Wales, Northern Ireland and the Republic of Ireland, and produce intelligence on health- related issues as well as on some healthcare. They are each responsible for a particular geographic region and the main target groups for the information are policy makers, managers, clinicians and the wider public. Nine of the observatories are located in England, collaborate according to a national plan, and became on April 1^st 2013 parts of Public Health England. The PHOs support commissioning in England and enable policy and deci- sion makers, as well as the public, to study data broken down to the local level which can

54 http://www.apho.org.uk

Measurements for Improved Quality in Healthcare