Quality and Clinical Governance

The sixth decade of the NHS was one in which quality became a central feature of NHS policy.  In general practice a Quality Outcomes Framework became one of the drivers of the pay of family doctors.  In the hospital service it became one of the key standards used by the Healthcare Commission to assess trusts.

It can be divided into several different themes

• Variations that reflect quality of care in the performance of hospitals

• Variations in the performance of clinical staff,

• Attempts to improve the care and cost-effectiveness of NHS organisations as a whole

Quality initiatives of each type had been commonplace in the US for years, but with a few major exceptions, such as the maternal mortality survey, they had been unusual in the UK  In the hospital service and in management it was presumed that it was the 'producers' rather than the 'consumers' who knew what services should be provided.  From the 1980s onwards it came to be recognised that it is the customer rather than the provider who ultimately defined quality. The rise of consumerism, the media and Internet played a part in the creation of a better informed and more critical public.  The NHS had discovered the patient.

Hospital performance, quality and mortality

The US has long been in the lead in the theoretical and practical approaches to clinical and organisational quality as a timeline shows.  Quality had been central to the agenda of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Agency for Healthcare Research and Quality (AHRQ).  The Institute of Healthcare Improvement, a non-for-profit organization leading the improvement of health care throughout the world, based in Cambridge, Massachusetts, was founded in 1991. An extensive review by RAND Health documented shortcomings in safety and effectiveness. _{(Schuster MA et al, Millbank Quarterly 1998; 76: 517-63)}.

Quality of life measures, for example the pioneering SF-36 from the US, were brought to the UK.  The work of  John Wennberg and the Dartmouth Atlas showed unwarranted variations in health care delivery.  Variations in the rates of coronary artery and carotid artery surgery, even in the best academic centres, was a reminder of how empirical was much of clinical medicine.

There was an increasing understanding in the professions and management of the problems of quality and the literature recorded the substantial number of medical errors and 'near misses'.  Major system problems were the principal source of many errors in a study of  New York in 1990.  In 1999 a report was published by the Institute of Medicine, which was directed at elected representatives and healthcare leaders as well as doctors.. (Kohn LT, ed, Corrigan JM, ed, Donaldson MS, ed. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999).  It was followed in 2001 by Crossing the Quality Chasm, (Committee on Quality of Health Care in America.  Washington, DC: National Academy Press; 2001.)  this showed that the implementation of standardised performance measures for heart attack, heart failure and pneumonia by the JCAHO in 2002,  to track performance and encourage improvement in performance, was followed by significant improvement in outcome. ^{Williams SC, Schmaltz S, NEJM 2005 353: 255-264.}  A review five years after the publication of To Err is Human showed substantial progress to increase hospital safety was being made, at least in the US, often led by clinicians keen to improve patient care. ^{Five Years After To Err Is Human: What Have We Learned? Leape and Berwick JAMA.2005: 293: 2384-2390.}  A further Institute of Medicine report in 2008, Knowing What Works in Health Care: A Roadmap for the Nation, proposed a national program to assess the effectiveness of clinical services and to provide credible, unbiased information about what really works in health care. It recommended that Congress direct the U.S. Department of Health and Human Services to establish a program  to set priorities for evaluating clinical services and to conduct systematic reviews of the evidence and develop standards for creating clinical practice guidelines, which could help minimize use of questionable services and target services to the patients most likely to benefit. It looked rather like NICE - for once the England being ahead of the US.

The UK responded with its own analysis, An Organisation with a Memory (2000).  Making the debate public made it more visible, and the message clearer.  It made the size of the problem obvious, focusing on events where there was wide agreement that something had gone wrong.  In 2003 the Nuffield Trust published a review, The quest for quality in the NHS: a mid-term evaluation of the ten-year quality agenda. (Leatherman S & Sutherland K, London, Nuffield Trust, 2003), examining achievement in terms of access, capacity, public perception, effectiveness and equity. The authors concluded that much remained to be done but that  initiatives were moving in the right direction.  The BMJ published a substantial editorial on the report.  In 2005 the same authors published more than 100 charts demonstrating the UK's performance in international terms, The quest for quality in the NHS _{(2005, Radcliffe Publishing) (Charting a new course, 7 July HSJ 2005, 26-29).} While there were improvements, for example in mortality from cancer, other developed countries were doing better.

Hospital variation

Professional staffing ratios influenced mortality rates.  In the USA research on nurse ratios in surgical units in Philadelphia showed that after adjusting for patient and hospital characteristics, each additional patient per registered nurse increased the likelihood of dying within 30 days of admission by 7%, and increased substantially nurse burn-out and job dissatisfaction. (JAMA. 2002;288:1987-1993). In the UK Professor Brian Jarman & his colleagues standardised for age, sex, socio-demographic background, key diagnoses and the number of emergency admissions.  Hospital standardized mortality ratios (HSMRs) were calculated for each English Trust and the trusts presented sharply different outcomes for patients once all these factors had been taken into account.  The factor that correlated best with performance was the number of doctors on the staff.  Taken overall, the death rates in major English hospitals seemed to be dropping about 2.5% per year. 

For more than a decade league tables of the mortality rates of US hospitals had been published. However mortality rates and other clinical indicators at hospital or trust level were not published until 1994 in Scotland and 1999 in England.  Clinical performance indicators included such items as the number of deaths in hospitals following fractures of the hip, and deaths within 30 days of admission for a heart attack.  As in the USA  publication was followed by protests that data might be inaccurate and misleading.  In the US patients could use not only printed information but web sites to view the number of cases specific hospitals handled, their outcome and the star rating accorded to their local hospitals, e.g. www.healthgrades.com and www.healthcarechoices.org.  In England at the beginning of the decade politicians thought such information was not intended to encourage patients to shop around for better treatment; later with Alan Millburn  this line changed.

In England as in the US the clinical performance of hospitals varied substantially.  In 2000, the US Health Care Financing Administration (now the Centers for Medicare & Medicaid Services) reported on 24 indicators of the quality of care delivered to Medicare beneficiaries (primarily in fee-for-service) in 1998-1999. These indicators measured delivery of services that evidence showed to be effective in preventing or treating breast cancer, diabetes, myocardial infarction, heart failure, pneumonia, and stroke. (Jencks SF, Cuerdon T, Burwen DR, et al. Quality of medical care delivered to Medicare beneficiaries: a profile at state and national levels. JAMA. 2000;284:1670-1676. Quality was rising up the NHS agenda and in March 2000 the BMJ devoted a themed issue to safe health care.

"Star" ratings were introduced in 2001.  The system was refined in 2004 with the publication of Standards for Better Health, a consultative document proposing standards that encompassed safety, clinical and cost effectiveness, governance, patient focus, accessible and responsive care, care environment and amenities, and public health. The Healthcare Commission built on such foundations.

Adverse incidents in the UK

An attempt to quantify the problem in the UK by retrospective record review in 2001 showed that almost 11% of hospital patients experienced an adverse event, over half of which were deemed preventable with ordinary standards of care.  A third of the events led to moderate or greater disability, or to death.  The Audit Commission, in its report A Spoonful of Sugar, (December 2001) reviewed the use of medicines in NHS hospitals, found that medication errors occurred too often and their effect on patients and NHS costs could be profound.  The National Patient Safety Agency,  established in July  2001 produced preliminary results in 2002 from pilot trials in 28 trusts, which showed over 20,000 adverse incidents over a nine-month period. 

Volume and safety

For many years it had been known that a relation exists between the volume of procedures and the outcome of treatment, promising a way to improve patient safety.  In 1996, the NHS Centre for Reviews and Dissemination published a systematic review to determine for which procedures such a relation existed. The list included coronary artery bypass surgery, paediatric heart surgery, acute myocardial infarction, coronary angioplasty, aortic aneurysm, amputation of the lower limb, gastric surgery, cholecystectomy, intestinal operations, knee replacement, and neonatal intensive care.  Such work looked set to modify the pattern of NHS hospital services. A study supported by the US Agency for Healthcare Research and Quality published in the New England Journal of Medicine demonstrated that while hospitals with high annual volumes of certain types of procedures had lower death rates, the true association was with surgeons who had a high volume of cases, rather than with the hospital per se. Improved data on hospital inpatient outcome were included the publication of hospital mortality "league tables".  Such figures had been published in the USA for over a decade, and appeared in England in 1999. 

Dr Foster

An independent company, Dr Foster, was established early in 2001 in the UK to provide authoritative information for patients on health service performance. The unit at Imperial College, directed by Professor Sir Brian Jarman, produces a variety of information.  With an independent editorial board, it mined available sources of information and the Department of Health, recognising its media and presentational skills, became its main customer and it produced systems for the Healthcare Commission as well.  The scope and usefulness of the material on its web site steadily increased, and details of the methodology used were provided.  A Sunday Times Hospital Guide, (15th May 2004) provided comparative information on 153 hospital trusts in England.  While such information was often available in the US free of cost, Dr Foster charged for access and did not provide depth of information on individual clinicians.

Variations in the performance of clinicians

In earlier times, all that had been expected of doctors, who had been trained in a service with a strong public service ethos, was that they should do their best by their own lights although the professions had long had an interest in competence and quality of care.  Regulatory bodies such as the GMC looked at individual competence.  Colleges would inspect hospitals to see that training standards were maintained.  Internationally a basic ethical principle of medicine, first do no harm, was being taken seriously.  Studies world wide showed that adverse events in hospital care affected some 10% of patients. The ethos of medicine was changing and the  development of controlled trials, meta-analyses, guidelines and organisations such as the Cochrane Collaboration was bringing to an end an era in which clinical experience alone was seen as adequate.

Evidence based medicine

Evidence based medicine was now becoming an integral part of many undergraduate, postgraduate and continuing educational programmes.  Accurate, accessible and regularly updated sources of evidence were becoming widely available though the process of summarising the evidence was daunting.  It was often hard to show that clinical practice was greatly affected or that clinical outcomes were better, though few would disown the hypothesis that on average providing evidence-based procedures would improve clinical outcomes.  Often it was clear enough what should be done, for example elderly people should receive influenza vaccine.  At the least, student textbooks were more frequently based on good clinical studies than in the past.

The Cochrane Collaboration had been established in 1992 with funds from the NHS Research and Development Programme, to help people to make well informed clinical decisions by preparing, maintaining and ensuring the accessibility of systematic reviews of the effects of health care interventions.  It rapidly became an international movement, producing successive reviews as the Cochrane Library and Database of Systematic Reviews.   How could stroke and its effects be prevented and treated?  What drugs should be used for malaria?  Individual studies might seem to deal with the minutiae of UK medicine, for example which drug was most effective in eclamptic fits related to pregnancy and delivery, but could produce compelling evidence for a change to clinical practice sometimes of particular value to developing countries where the incidence could be far higher. 

Clinical mishaps

The NHS and professionals were exposed to a level of scrutiny from within, and by the public, media and politics, that had not hitherto existed. When serious harm to patients had occurred, or events might lead to widespread loss of confidence, it was commonplace to hold an inquiry, sometimes a public one.  In the 1970s a number of inquiries were held into mental illness, mental handicap and geriatric hospitals. Issues were identified repeatedly, as if it was impossible to learn the lessons, e.g. isolation - geographical or organisational,  poor leadership, bad communication, problems with NHS systems or individual's competence,  and obstacles placed in the way of those who raised concerns at an early stage. 

Occasionally the public expected too much, for example the reading of cervical smears and mammograms is not a precise science and there are always likely to be false negatives and false positives.  Had the media become more interested in problems?  Were staff less disciplined or dutiful than had been the case?  Was the system under too much pressure?  Were there interests, perhaps political, that relished the demonstration that professionals had feet of clay?  Financial problems were often involved, as in the case of delayed admissions, waiting lists and 'trolley waits'.   Pressure of work and inadequate supervision played their part. 

At Bristol at least 29 babies died after heart surgery at the Royal Infirmary, leading in 1998 to a lengthy General Medical Council (GMC) inquiry in which three doctors were found guilty of serious professional misconduct.  The report following a public inquiry costing £14 million, chaired by Professor Ian Kennedy, was  published in July 2001.  It added little to what was already known; there were organisational as well as clinical problems. Neither the Royal College nor the  Department of Health personnel had been alert when passed information about poor performance, and the hospital facilities were far from ideal in the number of staff and the split site.  Health professionals were expected to 'get by' and do their best in spite of inadequate buildings, equipment and staffing.  The BMJ said, in an editorial, that most chilling thought in the report was that there could have been 50, perhaps 500, even 5000 similar reports about other parts of the NHS. The ingredients that led to the excess deaths in Bristol occurred throughout the NHS. The report emphasized not only that the NHS had no system for monitoring quality and no reliable data but also there was no agreement on what constituted quality. "Thus the most essential tool in achieving, sustaining, and improving quality of care for the patient was lacking . . . clinicians had to satisfy only themselves [the report's italics] that the service was of sufficient quality."  The report recommended publication of clinical information to give both NHS staff and the public accurate outcome data, and the establishment of a new independent Office for Information on Healthcare Performance within the Commission for Health Improvement to collect and publish this.  The Department of Health, in its response in January 2002, accepted the majority of the recommendations some of which dealt with bodies it had established itself, e.g. a more independent role for the National Institute for Clinical Excellence (NICE) .  There would be a strengthened inspection role for the Commission for Health Improvement (CHI), and a new Council for the Quality of Health Care to coordinate the many bodies now involved in oversight of the NHS bringing together all the bodies working to improve standards in the NHS whose role is described below - NICE, CHI, the National Clinical Assessment Authority and the National Patient Safety Access Team.  No steps were taken to establish this Council, perhaps because Ian Kennedy who recommended it later became the chairman of the Healthcare Commission (CHAI). 

The reports of the clinical work of gynaecologist Rodney Ledward who was struck off by the GMC in 1998, after which there was a public inquiry that reported in June 2000, led the media to watch the cases coming in front of the GMC like hawks. The GMC received an increasing number of complaints, 1,000 in 1995, 3,000 in 1999 and 4,470 in 2000. 

The Shipman Enquiry

The conviction of Harold Shipman for serial murder dealt a further blow to confidence in the medical profession and its systems of self-governance. A GP, for many years in single-handed practice and with a personal past history of drug abuse, Shipman had administered heroin to many of his elderly female patients.  He was convicted at Preston Crown Court in January 2000 of the murder of 15 patients, and was sentenced to life imprisonment and later committed suicide.

In September 2000, the Secretary of State for Health announced that an enquiry into the Shipman case would be held in public under the terms of the Tribunals of Inquiry (Evidence) Act 1921. Both Houses of Parliament ratified this decision in January 2001. Dame Janet Smith DBE, a High Court judge, was appointed chairman of the Shipman Inquiry and the work of the public inquiry began in February 2001. The estimate of the number of his victims rose (the sixth report reported that he had begun killing early in his medical career while in the hospital service). Comparison of his general practice's death rates with those of other practitioners, and examination of his records, suggested that there had been some 215 deaths.

Regulatory reform and revalidation - and the role of the GMC

As part of the remedy for a public ill at ease with the profession, reform of the regulatory systems began.  The Royal Colleges, the BMA and its General Practice Committee, favoured 're-accreditation', the regular review of a doctor's work.  Surgical Colleges suggested that in future review surgeons might be reviewed by their peers every five years. The GMC  unanimously voted in 1999 for a system of continuing education and regular supervision of the standards of those in practice.   In June 2000 it issued a consultation document on Revalidating Doctors, as events appeared to be overtaking it. Under Sir Donald Irvine the GMC had begun to reshape itself to restore confidence. Irvine (and others including the then editor of the BMJ Richard Smith)  felt that a paternalistic profession and an inward looking system of medical regulation had dealt with only the most flagrant abuses. Without reform the GMC might find itself abolished and replaced with a new and rather different regulator. There was opposition from some quarters of the profession who thought the GMC was selling out.  Smith thought that one problem was that when there was a compromise between protecting people and being fair to doctors, the GMC sided with the doctors.  There were no agreed standards, criteria or thresholds for 'serious professional misconduct' - difficult in any case as appropriate medical care changes over the years. The GMC was prosecutor and jury, conflicting with the Human Rights Act 1998. The BMA and its own Central Consultants and Specialists Committee (CCSC) passed a motion of no confidence in the GMC in July 2000. Politicians and the media thought reforms were too slow.  The GMC revised the way complaints were screened and handled to speed the process, and aimed to work more closely with the health service.   The Government went to consultation on reforming its structure and constitution, increasing the lay membership.  The Medical Act 1983 (Amendment) Order 2002  was made in December 2002, allowing for changes to the GMC constitution to include 14 lay and 21 medical members, and for new elections for a council to meet for the first time in July 2003. 

Working in cooperation with the Department of Health, whose CMO, Professor Sir  Liam Donaldson, supported regular appraisal and revalidation of all doctors in the NHS, a new system was agreed.  Assuming the passage of legislation, the first doctors would be revalidated some two years later.  Doctors would have to demonstrate regularly that they were fit to practice, and those who were successful would be granted a licence to practice.  Those working in an organisational setting with its own annual appraisal system could take the "appraisal route".  Others would follow an "independent route" of revalidation.  The changes, outlined in A Licence to Practice and Revalidation, published in April 2003  make a  licence to practise a legal requirement for all registered doctors in the public or private sectors. The licence would initially be granted automatically by the GMC, but doctors would then be "revalidated" every five years to keep it.  Outcomes of the revalidation procedure would be public knowledge, and the processes will be subject to audit, inspection, and spot checks by the GMC.  In the wake of the final report of the Shipman inquiry that criticised the GMC proposals as lacking sufficient rigour, Sir Liam Donaldson, was asked to review the role of the GMC while the introduction of revalidation was be delayed.  Published in July 2006 for consultation, it was proposed to

Death Certification

The second and third reports of the Shipman Enquiry dealt with  the conduct of the police investigation and the system for death and cremation certification and for the investigation of deaths by coroners.  In 2004 government announced a new system of certification.  Each coroner's area would have a medical examiner playing key role in verifying the cause of deaths.  Deaths would be verified by a doctor, paramedic, or senior nurse, who will then complete a verification form. The doctor who had treated the dead person in the immediate past will issue a certificate of the medical cause of death. After that the medical examiner will seek information from the family and elsewhere to confirm the cause of death and authorise burial or cremation, without having to refer the death to the coroner. The fifth report stated that the GMC had "fundamental flaws", criticized the reforms undertaken by the GMC and said that in 3-4 years time the GMC should be evaluated.  If it was not operating satisfactorily by then, it should be considered whether the GMC functions should be undertaken by a different body.  The GMC's system of revalidation was also criticized as unlikely to so the job and was put on hold by Government pending a further review. The report made more than 100 recommendations. These included:  

• A telephone helpline for patients and health professionals to raise concerns about doctors' performance or conduct

• A central database of information about every doctor in the United Kingdom to which primary care trusts and employers would have access

• Improved monitoring of prescribed drugs

• The GMC to be accountable to parliament

• The GMC's constitution to be changed so it has more appointed members who are "not beholden to an electorate" and do not see themselves as representing doctors

• Patients to have the chance to refuse to be treated by a doctor who is subject to conditions.

Source BMJ 2005, 330, 10.

The natural anxieties of patients had, however, unfortunate side effects.  Though some patients might feel that a particular unit's clinical services were poor, subsequent enquiries might not support their accusations.  Doctors might be inappropriately vilified.  A Liverpool paediatric cardiac surgeon doctor subjected to a patients' campaign, though exonerated, ceased to operate.

Clinical Governance

In 1992 the Cadbury Report had identified principles of good governance in organisations, integrity, openness and accountability.  This was taken further in the Nolan Report (1997) and other subsequent management orientated documents.  Government saw clinical governance as a tool that would deliver quality.  It drew on the wide range of quality techniques and initiatives developed world wide over the previous years.  

The purpose of clinical governance, according to the Commission for Health Improvement (CHI) (2001) was to ensure that patients received the highest quality of NHS care possible and it covered the organisation’s systems and processes for monitoring and improving services, including:

• consultation and patient involvement
• clinical risk management
• clinical audit
• research and effectiveness
• staffing and staff management
• education, training and continuing personal and professional development
• the use of information about the patients’ experience, outcomes and processes

It should ensure

• continuous improvement of patient services and care
• a patient-centred approach that includes treating patients courteously, involving them in decisions about their care and keeping them informed
• a commitment to quality, which ensures that health professionals are up to date in their practices and properly supervised where necessary
• the prevention of clinical errors wherever possible and the commitment to learn from mistakes and share that learning with others

Positive aspects of clinical governance included

• annual appraisal of clinical staff to ensure that they, and management, thought about the work to be done

• increased accent on clinical audit, even though there were as yet too few sensible outcome measures

• the recognition of the importance of continuing medical education.

Clinical governance reflected a fundamental change in powers and responsibility of managers and consultants; consultants could no longer regard themselves as free-floating entities; trusts and consultants had mutual responsibilities.  However some saw the process as jargon-rich and progress was in any case slow.  After three years a report from the West Midlands Region suggested that while structures and systems were in place, as yet there was little real difference in clinical activities and attitudes._{Walshe K, Scope to improve. HSJ 2000, 26 Oct, 30-1.}  Ensuring adherence to National Service Frameworks, for example, required the collection of substantial quantities of data by GPs, appropriate computer systems and data entry.  Mandating quality through central initiatives had not been especially successful in other countries; was it likely to be more effective in Britain?  Inevitably implementation varied from place to place.  With good leadership, local projects to improve patient management might multiply, or it might seem removed from the day to day concerns of clinical staff and incapable of answering questions such as "how can we improve procedures for a normal delivery" 

Body parts retention

Pathologists who had, for decades had routinely kept blood specimens, histological slides and pathological preparations found that this practice was unacceptable to some, once it was public knowledge.  At Alder Hey Hospital, matters had gone further.  A report by Michael Redfern QC showed that a huge collection of organs had been built up without full parental consent being obtained, or in some cases even sought.  Sometimes organs, for example the thymus, had been 'harvested' and made available to pharmaceutical companies.  500 parents joined a legal action for massive compensation.  A related enquiry by the Chief Medical Officer, Liam Donaldson, showed that more than 105,000 body parts were stored in English hospitals and medical schools, half dating from more than 30 years previously.  This was no surprise to any British trained doctor, part of whose professional education had consisted of the study of preserved specimens showing the marks of disease, though at times the retention of organs had gone far beyond that required for bona fide research.  In April 2000, Mrs. Elaine Isaacs discovered that, without her knowledge or consent, the brain of her late husband was removed after a coroner's post mortem and given to Manchester University for research purposes. Following investigation Dr Jeremy Metters, Her Majesty's Inspector of Anatomy, concluded that the protocols for the research, between 1985-1997, did not take proper account of the Human Tissue Act or the Coroners' Rules.  New legislation was introduced to ensure that informed consent was obtained from patients or relatives.  

The costs of negligence

Each year the costs of settling legal actions for clinical negligence were rising. Constant pressure to put more people through the system, and old equipment in outdated buildings did nothing to improve quality.  Traditionally the costs of compensation had fallen on the individual clinician and his insurance, but it shifted first to the hospital concerned, and in April 2001 to the NHS Litigation Authority.    Much money went to very large compensation awards to provide long term care for badly damaged patients.  A substantial backlog of claims existed estimated by the National Audit Office to exceed £4 billion. The ever rising costs led Labour, in 2001, to review how compensation was handled. The Chief Medical Officer was asked to report and in June 2003 he published Making Amends.. It was proposed that doctors would be under a duty of candour to report mistakes, there might be teams of investigators to assess claims, with a maximum of £30,000 compensation in most cases.  The right to legal action would be removed once compensation had been paid. 

Under the National Health Service Reform and Health Care Professions Act 2002 the government established the Council for the Regulation of Healthcare Professionals chaired by Jane Wesson, previously Chair of the National Clinical Assessment Authority (NCAA).  The  Council, which was called for in the Kennedy Report, would have members from the professions and others (in a slight majority) representing public interests and the NHS.  It would oversee

• 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

 The Council decided to change its name to the Council for Healthcare Regulatory Excellence, because it would better reflect our role and purpose and avoid possible confusion with bodies of a similar name.

Regulation

As part of its drive for quality, the Labour government created five regulatory agencies

• The National Institute for Clinical Excellence

• The Commission for Health Improvement (successor body the Healthcare Commission)

• The Modernisation Agency

• The National Patient Safety Agency

• The National Clinical Assessment Authority.

All were well resourced, most were ultimately accountable to central government, and they were part of a wider movement towards regulation and audit.  Because of the high salaries paid, they attracted staff from trusts and added to their burdens. They might duplicate their demands; for example both CHI and the National Audit Office checked out clinical governance, a situation remedied by the creation of the Healthcare Commission, (the Commission for Health Care Inspection and Audit) from April 2004. 

A consultation aper, A first class service, (1998) heralded a positive shoal of related activities and new bodies. Government was becoming increasingly impatient with professional self-regulation, and the time taken by GMC procedures to come to a final decision.   High profile cases stimulated the introduction of new measures to monitor performance and to ban swiftly doctors who were dangerous and incompetent, challenging the medical profession’s traditional independence.  

Government proposals attempted to do two things, not necessarily compatible.  First the 'person' approach, looking for individual errors; second a system approach looking at the entire system and introducing risk management, memory aids, and the reporting of problems to ensure their rectification.  The regulatory bodies equally might follow either a sanction driven approach, or might attempt to stimulate development on the assumption that most bodies were essentially well-meaning, and would improve their performance given the chance.

National Clinical Assessment Authority (NCAA),

The NHS Plan of July 2000 proposed a supervisory body to oversee professional regulatory bodies.  It also established a National Clinical Assessment Authority (NCAA.)  in April 2001, separate from the Department of Health, as a Special Health Authority. NCAA operated on a confidential basis, bringing expert support and advice to situations where doctors' performance was being questioned.   Cases could be referred to NCAA by an employer or by the doctor personally.  If a problem could not be resolved locally, NCAA would undertake its own assessment, report on the action that might be taken and monitor what then happened.  Most referrals simply required advice, but in its first year roughly twenty required full assessment.  The roles were set out by NCAA.

• NCAA assesses the contribution of individual doctors to the local service by addressing individual performance issues;
• The GMC investigates serious misconduct, health or performance issues of individual doctors which may call into question the doctor's fitness to remain on the medical register.
• CHI assesses clinical governance in all NHS organisations, and will review systems in health authorities and trusts for identifying and handling poor performance. CHI also investigates when there are serious system failures;

In 2005 the NCAA became part of the National Patient Safety Agency.

National Patient Safety Agency

Building a safer NHS for patients, (2001) put an emphasis on reporting adverse events and risk reduction.  The independent National Patient Safety Agency (NPSA) was established in July 2001, a 'mandatory system for logging all failures, mistakes, errors and near-misses across the health service'  to feed lessons learned back into practice, and work alongside the Commission for Health Improvement, later the Healthcare Commission, and the Clinical Governance Support Team. In 2005 the Agency expanded to incorporate the National Clinical Assessment Service and the National Research Ethics Service.  It also took over the three Confidential Enquiries into: Suicide and Homicide, Maternal and Child Health, and Patient Outcome and Death.

After pilot trials a national reporting and learning system to collect reports of health system failures and errors that compromised patients' safety was launched in 2004.  This aimed to improve patients' safety by collecting reports across England and Wales. The system would mostly use information from existing local risk management systems but health professionals could report directly if they preferred.  Managers should decide the appropriate action to take when a serious incident occurred, whether or not deliberate harm was intended, whether the staff member had any medical problem or incapacity, whether harm might have been foreseen, and whether others would have done the same thing under similar circumstances.

The National Institute for Clinical Excellence (NICE)

When the NHS was established in 1948, its clinical standards were those of individual clinicians and their professional organizations. If the emerging NHS had tried to challenge the traditional freedom of clinicians, the medical profession would have walked away from it.  Attitudes changed. Medical practice based on evidence, rather than on anecdote and opinion, gained credence. Studies during the 1990s showed that the results of clinical research were poorly incorporated into routine care and that inappropriate variations in the standards of clinical practice abounded.  As part of the 1998 Comprehensive Spending Review officials were asked to look at ways of improving efficiency and effectiveness in the NHS.  The report proposed a systematic and national approach to the appraisal and management of new technologies.  The White Paper, The New NHS (December 1997), announced the establishment of a new National Institute for Clinical Excellence, with a remit to include guidance on drugs and other technologies.

NICE profoundly changed the way that England And Wales evaluated health interventions for the better.  Established in April 1999, it brought together a  number of organisations previously established to work on quality issues in England and Wales. 

Its initial functions were

• appraising new technologies, including drugs, and from 2003 to assess whether interventional procedures used for diagnosis or treatment were safe enough and worked well enough for routine use in the NHS.

• deciding which should be encouraged in the NHS, and which should be held back.  

• producing or approving clinical guidelines (for example on GP referral to hospital

• identifying ways of improving the quality of care, and encouraging quality improvement

• funding the four confidential enquiries into maternal deaths, stillbirths and deaths in infancy, perioperative deaths, and suicides and homicides by people with mental illness.

NICE was established as a Special Health Authority (therefore accountable to the Department of Health.)  It stood at the controversial intersection of quality, innovation, access, reduction of practice variations and cost, with a remit to operate in an open way and to deal with clinical and cost uncertainties. Initially a small organisation chaired by Sir Michael Rawlins, within two years, often by contracting work out, it had issued 22 reports.  By April 2005  the number had risen to 86, often important to specific but small groups of patients.  NICE did not accept or reject health care technologies on cost effectiveness grounds alone, although this was a major factor. However above £30,000/quality adjusted life year (QALY) the case for supporting the technology had to be increasingly strong. Some criticised the threshold as too low, excluding some treatments; others that it was too high, with the result that the health service had to economise on forms of care that were possibly more worthwhile, but had not been mandated by NICE.

Steadily NICE's credibility grew, it came in some part to replace the National Service Frameworks and it became a major feature of the landscape of clinical medicine.  Its guidelines were increasingly welcomed, and its work began to achieve international recognition. Internationally, NICE was unusual in having a formal appeals process. In 2004 a review of arms' length bodies recommended that NICE should take over the the public health functions of the Health Development Agency.  From 1 April 2005  it became the National Institute for Health and Clinical Excellence (still known as NICE), an independent organisation responsible for providing national guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.

Regularly government would suggest new  groups of drugs and procedures for assessment, usually of new procedures, rather then existing patterns of treatment. The reports fell into several main categories:  ( Bosanquet N, Health Service Journal, 19 June 2003, p 30-1)

• Cancer treatment and chemotherapy

• Heart disease

• Surgery, laparoscopic and orthopaedic

• Lifestyle drugs, smoking and weight reduction

• Central nervous system and mental illness including Alzheimer

• Long-term conditions, rheumatoid arthritis and renal disease. 

In September 2006 NICE was asked to launch a new programme to help the NHS identify interventions that are not effective, to help the NHS make better use of its resources by reducing spending on ineffective treatments, that did not improve patient care or represent good value for money.  Technology appraisals would be undertaken where clinical evidence suggested that current practice is no longer appropriate or effective and does not improve patient care. For example, a clinical guideline could be developed on how to manage sore throats in children. Antibiotics are known to be largely ineffective, for example they will not work if it is a viral infection. NHS could then invest in drugs and approaches to care that make a positive difference to patients’ lives

An early aim was to end ‘postcode prescribing’ where treatment was determined by local decision and place of residence.  In October 2001 government decided that the NHS should be compelled to implement the recommendations.  NICE decisions were made without consideration of  budgetary constraint. Zyban and other anti-smoking devices were likely to cost an additional £50 million/year and a drug to treat hepatitis C £18 million. Courses of in-vitro fertilisation, free for women between 23-39, also had major cost consequences.  Most recommendations suggested routine use of technologies, or accepted them with major or minor restrictions. In 2002 the NICE estimated that its guidance could increase costs to the NHS in England and Wales by about £575 million, and in 2007 by £1.6 billion.  Prescribing costs in general practice rose at 10% per year or more, substantially as a result of NICE recommendations.  Its guidance was in theory mandatory for the NHS so sometimes the choice was to cut services or fund the recommendations. There was anxiety that the treatments that Trusts had to cut might have, in fact, a higher QUALY than those NICE approved and which became mandatory.  While the government set up systems of monitoring compliance, in many cases, particularly when costly treatment was involved, primary care trusts refused payment, and the post-code lottery persisted.

Controversy was never far from the surface.  NICE early ran into dispute over the flu drug Relenza and beta interferon for multiple sclerosis.   In 2006 Pfizer and another company took court action over its decision to restrict access to dementia drugs to those at a moderate, not an early stage, seeking a judicial review of how the NICE reached its conclusions.  The Court supported the process by which NICE came to its conclusion.  NICE was responsible for delayed use of some new drugs; it did not approve atypical anti-psychotics until 2002, ten years after they had entered clinical practice.   It probably increased  the dissemination of some technologies judged cost-effective, e.g. taxanes, but there was less compliance with other recommendations, for example new drugs for arthritis and schizophrenia.  It was less successful in discouraging the use of drugs thought not to be cost effective.  Neither was it clear that when changes had occurred, it was the result of the guidance rather than manufacturers' marketing efforts. While denying that it was rationing health care, others contended that prioritization inevitably meant this.  In the absence of detailed knowledge of individual patients only general guidance could be given - while it was individual patients that received or did not receive treatment.  NICE inevitably had to consider treatments one at a time and not necessarily the whole range of alternatives available. 

The method by which its appraisals were conducted were sometimes criticised, as by House of Commons health select committee which conducted an inquiry in January 2002.  NICE rejected such adverse comments but the Committee's report called for a move away from isolated technological appraisals towards broader guidance, and more willingness to work with the British National Formulary and the Drug and Therapeutic Bulletin when making clinical assessments.  NICE asked WHO Regional office for Europe to conduct a review of  technology appraisal programme. The review was largely supportive, although there were comments on the difficulty in reconciling openness of decision-making and the use of commercially confidential material provided by  the pharmaceutical industry.  The US Deputy secretary for health, Alex Alzar, perhaps backing US drug companies, said that mechanisms such as NICE "stifled innovation" and drug companies repeatedly lobbied ministers to allow their drugs to be available on the NHS more quickly.

Scotland, with its greater health funding per capita, made drugs available more rapidly. NICE also appeared to take its time in making assessments, and was criticised for its delays and decisions on Tarceva (lung cancer), Velcade (multiple myeloma), Alzheimer's drugs, Alimta (mesothelioma) and Gliadel (brain tumours).  NICE was itself under financial constraints; its budget was reduced in 2005 and one of the three committees undertaking assessments was scrapped.  This increased the time it took to approve drugs, for example new ones used in breast and colon cancer. While doctors could prescribe drugs licensed by the Medicines and Healthcare Products Regulatory Authority (MHRA), in practice it was rare to get NHS funding in advance of  a NICE recommendation. 

In January 2008 the House of Commons Health Select Committee published its second report into NICE, six years after its first.  The committee questioned the financial threshold used by NICE, suggested that appraisals should appear at the time of drug launch, not long afterwards, and was concerned about the quality of data used, much of which was derived from the drug industry.

The Commission for Health Improvement

Until the establishment of the Commission for Health Improvement (CHI), independent inspection of NHS hospitals was largely unknown, unlike the situation in the USA where there was a lengthy tradition and substantial experience. CHI was established in April 2000 to undertake a rolling programme of provider and service reviews.  Kenneth Robinson had established the Hospital (later Health) Advisory Service in the sixties in the wake of scandals in long term care but it had neither the scope nor size of CHI.  CHI was immediately asked to investigate problems in two trusts in Cumbria and the Carmarthenshire in Wales.  The hard hitting reports established its position as a trouble-shooter and the classic ingredients, a whistleblower, a culture of secrecy and previous internal enquiries that had failed to bring about sufficient action. There was a tension between the role imposed by government as a watchdog with a punitive function, reviewing every Trust and the concept of a catalyst promoting continuous quality improvement.  The staff and budget of CHI increased fast. By 2002  as many as nine reports might be published in a single week.   CHI attempted to assess the processes of care and the way the organization operated, but assessing the quality and outcome of care was harder. The role of CHI was diagnostic.  The follow-up of recommendations was for others, and it had no power to enforce its recommendations.

CHI was not independent of the Department of Health.   Professor Ian Kennedy's report on the problems of paediatric heart surgery at Bristol later recommended that it should be and Government accepted this proposal.  The NHS Reform and Healthcare Professions Act (2002) tried to rationalize inspection, gave CHI a wider role and greater independence, and the responsibility for the private health sector through the National Care Standards Commission, initially a separate organization.  It required the commission to publish information on performance and from 2003 made CHI responsible for the star ratings system (previously calculated by the Department of Health) comparatively free from government intervention.  The star rating system and the number of hospitals in each band was, however, highly subjective.  Drawing on its experience of visits, in 2003 CHI published a report, Getting Better? a report on the NHS, identifying such problems as infection control, too great a concentration on waiting lists, and a lack of doctors in management positions.

CHI relied heavily on the professional expertise of its teams, rather than explicit standards. It had been directed to study "clinical governance" and this largely focused on process issues rather than patient care per se.  The reviews led to much trust activity in the years before and after; then rather less.  The follow up was for others, regional offices or strategic health authorities, so the feedback loop was not complete.

Healthcare Commission

In April 2002, the government announced plans for a new Commission for Healthcare Audit and Inspection (CHAI)  with greater powers, to subsume the existing Commission for Health Improvement, the value-for money-responsibilities of the Audit Commission and those of the National Care Standards Commission (concerned with licensing private health care and only in operation for three weeks). "I" now stood for inspection, rather than improvement. CHAI would have four roles, setting standards, audit and inspection of performance, clinical governance and finance, improvement (alongside the Modernisation Agency itself now living on borrowed time) and enforcement, working with strategic health authorities.

It seemed natural justice that the commission should be established under the chairmanship of Professor Sir Ian Kennedy, the author of the Bristol report. At the time of its establishment in April 2004 it was rebranded as  the Healthcare Commission.  The new unified regulator would inspect all health care providers – public and private – against "uniform, clear and comprehensive standards". It was soon clear that there would be a clean break between the old and the new organisations.  Peter Homa, initially appointed as chief executive, resigned after two months for the new chairman wished to act in a hands-on manner, rethinking the way the organisation would function.  Sir Ian then appointed his own advisory panel without consulting his recently appointed board.

The Healthcare Commission, reporting in July 2004, said  that the 'inverse care law' of Julian Tudor Hart (Lancet 1971; 1:405-12) still held sway.  Those most needing care were least likely to receive it (or the funding of the places where they lived was less.)  An ambitious undertaking for so young an organisation, the report profiled several issues, such as the care of ethnic minorities, children, and the elderly, but resembled in some respects a Department of Health document.  A useful compendium of information, much of its content was devoted to government plans, and rather less to documenting gaps in the service.

The Commission wished to rationalise the overlap between organisations responsible for healthcare inspection, to provide a more coordinated approach to visits and requests for information. But Sir Ian found it difficult to identify the whole range of bodies who saw themselves as 'statutorily required' to inspect. He  wished to make visits more targeted (by the use of prior information) and more proportionate.  The Healthcare Commission published the star ratings in 2004 for hospitals, primary care and mental health care trusts, four of the new Foundation Trusts losing their third star. After consulting on a system to replace the star ratings a new system based on "core standards" was introduced, using seven topics, safety, clinical and cost effectiveness, governance, patient focus, accessible and responsive care, the care environment and amenities, and public health. Trusts worked had at a self assessment as to how far they met these standards, and the separate and defined elements of each.  They would self-certify the extent to which they met the standards, subject to an external check.

The first annual "health check" ratings using the new system were published in October 2006.  It painted a mixed picture of the quality of services in the NHS. The score for quality covered areas that mattered to patients, including safety, cleanliness and effectiveness.

• whether a trust is meeting basic standards of care
• how a trust is performing in relation to targets set by Government
• the results of our reviews of specific services or topics, such as tobacco control, community mental health, management of admissions and diagnostic services

4% of 570 NHS trusts got the highest rating of ‘excellent’ for quality of services and a further 36% were rated ‘good’, while 51% were rated ‘fair’ and 9% were rated ‘weak’.More than a third (37%) of trusts received a score of 'weak' for use of resources . This meant they failed to manage their finances adequately for the year to March 31st 2006. Only 3% of trusts were given a score of 'excellent' for resources, 13% were given a score of 'good' and 47% of trusts were 'fair'.

The Health Care Commission was not, however, guaranteed a long future.  In November 2006 the Department consulted on a proposal merge the three organisations, the Healthcare Commission, the Commissions for Social Care Inspection and the Mental Health Act Commission) into the Care Quality Commission, Ofcare for short.  A year later the Queen's speech to parliament announced legislation to create the new regulator "to ensure clean and safe services, and high quality care."  It could have the power to instigate a statutory warning notice demanding improvements, a formal caution, a temporary suspension of mandatory Ofcare registration, conditions restricting what can be provided or criminal prosecution.  Further consultation on the system of registration was undertaken in March 2008, and it was proposed to extend the need for registration to primary care.

In February 2008 the organisation of clinical audit, previously undertaken by the Commission was awarded to a consortium comprised of the Academy of Medical Royal Colleges, the Royal College of Nursing and the Long Term Conditions Alliance to be known as the Healthcare Quality Improvement Partnership. It would support a newly created National Clinical Audit Advisory Group (NCAAG), set up to provide advice and guidance on the overall programme of work, and to consider proposals for new audits or for discontinuing existing audits.