From Club Governance to Stakeholder Regulation Part 2

New Public Management, Medical Audit and Evidence Based Medicine

By the beginning of the 1990s, the GMC was under pressure to modernise itself. Yet, the principle of medical self-regulation had not been directly challenged. The same cannot be said for the principle of clinical autonomy in the NHS. As the previous section discussed, from the beginning of the 1980s onwards, the state increasingly adopted a more interventionist stance towards the day-to-day management of medical work in particular and the efficiency and quality of NHS care in general. This state of affairs would continue throughout the 1990s and into the first decade of the new millennium.

As noted previously, the early 1980s the Griffiths report introduced general management into the NHS. The rise of managerialism in the NHS slowly brought with it what was known as New Public Management (NPM) firmly to the foreground of the public service arena in the UK (Pollitt 1990, Hood 1991). According to Hood (1991, 1995a, 1995b), the principle components of NPM are six fold: 1) more active and accountable management. 2) A greater focus upon quality and outcomes with more explicit standards, targets and performance measures. 3) The break up of larger units into smaller ones. 4) More competition and a contract culture. 5) An increased focus on more flexible terms and conditions of employment. 6) A greater emphasis on public as consumer. The ideals of the Conservative Administration throughout the 1980s and into early 1990s were broadly in line with NPM ideas, as these in turn possessed an elective affinity with the principles espoused by Enthoven (1985). Enthoven had advocated the introduction of an internal market in the NHS and greater managerial control over medical work to ensure cost efficiency and increase service quality.

The publication of Working for Patients (Department of Health 1989) brought the internal market into the NHS through splitting purchasing and providing functions. By the end of the 1980s management had established control over hospital information systems and clinical budgets, which in themselves meant managers possessed more control over doctor’s clinical activities than any ‘outsider’ ever had. The state’s reforms further expanded managements influence to include the allocation of merit awards, the appointment of hospital consultants and annual reviews of their job descriptions. By the early 1990s Flynn noted that there had been a ‘tendency during the last decade, towards an erosion of professional dominance in the face of increased. managerial power’ (Flynn 1992: 50). However, and most importantly for the purpose of this topic, what really made the GMC, Royal Colleges and BMA sit up and take notice was that interventions such as Working for Patients revealed for the first time that state policy was undeniably following a line of reasoning which struck at the very heart of the concept of clinical freedom. Namely, given the rational and scientific basis of biomedicine, the outcomes produced by the application of medical expertise were not only open to codification and standardisation, but also surveillance and modification. This fact was vitally important for a state increasingly concerned with, on one hand, cost efficiency and the management of risk, and on the other hand, the promotion of patient involvement and choice in health care.

As the topic has discussed, by the beginning of the 1980s medical knowledge was rapidly expanding hand in hand with new forms of medical technology that were establishing new and more costly medical interventions. It also highlighted that there was a rise of patient complaints and medical litigation in the NHS as well as a continued failure of medicine’s elite institutions to meet head on the issue of underperforming doctors. This situation led the state to feel increasingly justified in developing strategies to monitor (and challenge and change) doctor’s clinical activities. By the end of the 1980s, the state was arguing that it was time "to develop a comprehensive set of measures of the outcome of much of the work of.. .doctors" (Department of Health 1989b: 2). It had decided, ‘to consider how the quality of medical care can best be improved by means of medical audit, and on the development of indicators of clinical outcome’ (Department of Health 1989b:2). First developed in the USA to track quality through analysing treatment outcomes, and endorsed by the BMA as a strategy to protect professional autonomy, medical audit seemed to be the perfect tool the state needed to place doctors under greater surveillance and control. The problem was, as a study published at the time indicated, ‘rank and file’ doctors may ‘regard overall financial limitations as being legitimate restrictions on their autonomy.[but do].not see a legitimate role for peer review or quality assurance’ (Harrison and Schulz 1989: 203). As the topic has already discussed, medicine’s occupational culture was based upon the ‘club rule’ that one doctor did not question the actions of another unless they were highly unethical or extremely out of line with accepted practice. Yet the Royal Colleges were ever aware of the turning political tide and had joined the BMA in viewing medical audit and peer review as a legitimate way of improving doctor performance while at the same time retaining medical autonomy. By the early 1990s, they were actively involved in promoting medical audit to the ‘rank and file’ of the profession (Hopkins 1990). The state needed such allies to make its reforms work and consequently had to accede to the view of medical audit possessed by the Royals Colleges and BMA. Namely, if medical audit was going to be used more frequently and formally, then it should follow what Pollitt (1993) called ‘the medical model’. This meant that its operation remained firmly in the hands of doctors themselves who would periodically advise management on outcomes as they saw fit. However, this was not the end of the matter. As 1990s progressed, the state would move towards introducing multi-disciplinary clinical audit and proactively sought to develop risk management strategies across professional groups (NHS Executive 1994, Kogan and Redfern 1995).

At the same time that the use of medical audit and clinical audit were on the rise, evidence-based medicine was developing to address regional variations in key performance outcome areas, such as mortality rates following surgery and length of stay in hospital following admission (Ham 1988, Berg 1997). By the end of the 1980s, technological developments like the computer had become more firmly linked to existing statistical and epidemiological techniques. This had led to a rapid increase in the ability to manage and analyse clinical outcomes and establish ‘low risk’ guidelines and protocols for doctors to follow (Wennberg 1988).Evidence-based medicine not only promised to help the state place medical work under greater surveillance, it also promised to help patients make more informed choices with regards to treatment. Nearly two hundred years had passed since the rise of biomedicine’s clinical gaze and the establishment of the hospital as a site of medical authority and autonomy. Finally, a mixture of political will and modern technology was supporting changes in the nature doctor-patient power relationship. As Wennberg (1988: 34) noted at the time, ‘[it] is now possible to speak of a new set of disciplines which together constitute the evaluative clinical sciences. They offer the promise of a scientific programme that can greatly improve clinical decision-making by decreasing uncertainty about the probabilities and the value to patients of the outcomes of care. They also offer new ways of communicating information to physicians and patients that can greatly increase understanding about the consequences of medical choices and thus help patients make decisions they truly want.’

By the mid-1990s, peer and managerial surveillance of individual doctor’s clinical activities had become the norm under the banner of promoting cost-efficiency, reducing risk and ensuring patient involvement in medical decision-making. The rapid development in ‘clinical standards’ to govern the performance of doctors and other health care staff was seen by many interested observers to be a consequence of the rise of the idea of ‘patient as consumer’. For example, Allsop and Mulcahy (1996) held the increasingly common view amongst commentators that the position of medicine in the health care division of labour had changed and indeed was continuing to change. Furthermore, they held that there was an expanding web of formal rules (i.e. guidelines and protocols) as well as informal rules (i.e. norms of behaviour held by an individual health care actor’s social networks) – operating both internally and externally to the medical profession itself – which were increasingly governing the day to day activities of individual doctors. This state of affairs, they felt, was a result of new relationships being forged between what they held to be the four main stakeholders involved in health care – government, citizens, managers and professionals. However, they also noted that rules and regulations to monitor medical work ‘are not enforceable unless those at the service delivery level choose to implement them. A thread running through this topic has been,[that the medical] profession is still in a position to determine what constitutes appropriate medical practice. Their knowledge is unique and even if guidelines and protocols were to be generally implemented, there would remain a large element of judgement in medical decision making about their application to a particular patient. Furthermore, if patients are to be involved in dealing with their own illness, advice and information often needs to be simplified, explained and filtered through the doctor. Patients, and their carers, need to remain allies of the profession if medical treatment is to be as successful as possible’ (Allsop and Mulcahy 1996: 203).

In summary, Allsop and Mulcahy held that the principle of medical autonomy in the NHS was being actively challenged. They also argued that, like other health and social care staff, ‘rank and file’ doctors were coming under increased surveillance and questioning from the state, management and patients. However, like Freidson (2001), they hold that the specialist nature of medical expertise means doctors need to be allowed to exercise discretion in their work and collegiate control over member straining, practice and discipline. This point will be discussed again later in this topic. What is important to highlight here is that recognising the need for doctors to possess discretion does not mean that they should operate without transparency and accountability. As historically had been the case due to medicines ‘club mentality’, as legally supported by the 1858 Medical Act, and reinforced by its dominance within the NHS. Indeed, things were changing and the profession and the public now needed to forge a new relationship. As Allsop and Mulcahy (1996: 203) went on to say: ‘[As] citizens and taxpayers, patients also have a right to expect accountability from the profession and a reassurance that internal forms of control, both formal and informal, are being used to maintain high standards of expert care’.

New Labour and Clinical Governance

This trend towards the increased surveillance of medical work inside and outside of the medical profession, alongside concurrent calls for self-regulatory professional institutions like the GMC to become more transparent and accountable, did not end with the election in 1997 of New Labour. Although generally critical of many of their Conservative predecessors’ health policies, under the guise of treating ‘patients as equal partners in the decision making process’ (Department of Health 2000: 2), New Labour introduced measures which placed doctors under even greater surveillance and further challenged their traditional clinical freedoms. New Labour proposed a comprehensive, management-led system of clinical governance designed to set and monitor standards governing medical work. Clinical governance is officially defined as ‘a framework through which the NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’ (Department of Health 1998: 33). Clinical standards are set nationally by the National Institute for Clinical Excellence (NICE), which was established in 1999. This body makes recommendations on the cost effectiveness of specific treatments and disseminates clinical standards and guidelines, based upon evidence-based research, for compulsory use by doctors. It also plays a role in developing what are called National Service Frameworks (NSFs), which look at the pathways between primary (i.e. community based) to secondary (i.e. hospital based) care followed by certain patient types (i.e. those suffering from heart disease, diabetes or mental health issues) to identify activity levels and productivity figures and improve service resource allocation. The local implementation of the NSF guidelines and NICE clinical standards are monitored by what was first called the Commission for Health Improvement (also established in 1999) which has more recently been renamed the Commission for Healthcare Audit and Inspection (CHAI). CHAI is empowered to visit hospital and primary care trusts and ensure they are following good clinical governance guidelines. It awards star ratings, similar to those given to hotels, and likewise scores them based on their performance against set criteria, for example, length of time patients spend on a waiting list. As a result of the Health and Social Care Act 2008, CHAI will be integrated with the Commission for Social Care Inspection and the Mental Health Act Commission, creating a single regulator for health and social care, the Care Quality Commission (CQC). This began operating in April 2009. Originally CHAI was supported in its activities by the National Patient Safety Agency (NPSA). This was established in 2002 and focuses upon promoting good health care practice. This function will not change as a result of the creation of CQC.

The Scientific Rationality of Performance Management

Given New Labour’s reforms, it is unsurprising that in his review of NHS reforms Light (1998: 431-2) stated that: ‘the national framework for performance management is extensive.

The White Papers propose establishment of evidence-based patterns and levels of service, clinical guidelines, and clinical performance review, in order to ensure patients of high uniform quality throughout the service’. Furthermore, Slater (2001: 874) believes that the New Labour’s NHS reforms in general, and clinical governance in particular, have established ‘a rationalistic bureaucratic discourse of regulation which reveals itself through increasingly extensive rule systems, the scientific measurement of objective standards, and the minimisation of the scope of human error. Behind it lies a faith in the efficacy of surveillance as a directive force in human affairs’. This new rationalistic-bureaucratic discourse, with its focus on the surveillance and management of risk through standard setting and transparent performance monitoring, has presented a significant challenge to the principle of professional self-regulation, as it has traditionally existed within the healthcare arena in the United Kingdom (Davies 2004). Indeed, New Labour has established a Council for the Regulation of the Health Care Professions, subsequently renamed the Council for Healthcare Regulatory Excellence. This oversees the professional bodies responsible for maintaining standards in health care. It also aims to increase inter-agency consistency in the regulation of health professionals (Department of Health 2001). It is composed of the presidents of each council it oversees alongside lay members. It reviews each council annually and will refer professional misconduct decisions made by a council to the High Court (Allsop 2006). The nine councils under its remit are: General Chiropractic Council (GCC) General Dental Council (GDC) General Medical Council (GMC) General Optical Council (GOC) General Osteopathic Council (GOsC) Health Professions Council (HPC) Nursing and Midwifery Council (NMC) Pharmaceutical Society of Northern Ireland (PSNI) Royal Pharmaceutical Society of Great Britain (RPSGB).

For all these changes the principle of medical self-regulation did remain. Primarily because of the cost implications presented by the alternative of a directly state controlled regulatory body. The state made it clear that the GMC and all other professional regulatory bodies must become more open to public scrutiny, responsive to changing clinical practice and NHS service needs, as well as publicly accountable for maintaining standards (Department of Health 2000). Given this, it would be expected that some changes to the makeup of the GMC would be made. Sure enough, in 2003 its executive membership was reduced to 35 members, 14 (40%) of whom are lay members. However it was noted that ‘elected and appointed medical members still form a majority on the council and the president, a doctor, is elected by the membership thus preserving a symbol of self-regulation’ (Allsop 2006:629).

What happened? New Labour’s NHS reforms can be seen to be part of its ‘third way’ modernisation agenda. It operates somewhere between the Conservative party’s rule of the market and the state socialism of the traditional Labour party. Furthermore, it is built upon the principle of ensuring partnership between stakeholders, and active patient involvement in health care delivery and reform. But most importantly, the reasons behind New Labour’s reforms to medical regulation in particular, and the governance of health and social care sphere in general, can be summed up in two words: Bristol and Shipman. Certainly, they are other important medical malpractice cases, such as the Alder Hay organ retention scandal (see Irvine, 2003 for a discussion of this and other cases). Yet without a doubt, Bristol and Shipman have had the most impact on the organisation of medical regulation. These two cases will be discussed in more detail in a moment. First, it is necessary to backtrack to the beginning of the 1990s in order to outline key events leading up to them.

Reforms in Undergraduate Medical Education

As the topic has already noted, the GMC had started the 1990s realising it had to make changes. In particular, it recognised the need to reform the content of undergraduate medical education to bring it in line with changes in the organisation and focus of the NHS. Here three key aspects of the existing course needed to be addressed. First, there was a lack of emphasis on inter-professional working practices, doctor’s communication skills and the patient’s perspectives of illness and disease. Second, there was a lack of integration between preclinical (i.e. classroom) education and clinical (i.e. hospital based) training, alongside an over emphasis on hospital as opposed to primary care. Third, advances in medical knowledge and technology meant that ‘factual overload’ was a very real issue facing the modern medical student. It also meant that school staff placed too much emphasis on assessing what students knew instead of what they could do (Nutton and Porter 1995). Yet as equally important as the need to align medical education to the changing needs of the NHS, was the recognition that the development of information technology and the knowledge based economy would place the concept of lifelong learning at the centre of Higher Education (Ransom 1994). Undergraduate medical education had to be reformed due to changes in the NHS and Higher Education and in 1993, the GMC published Tomorrows Doctors (GMC 1993). This advocated a patient centred model of medical education, focusing on multidisciplinary working and the assessment of student’s clinical and communication skills. It recommended a core-plus options curriculum design, early clinical exposure in hospital and primary care settings and the use of small group teaching methods to promote self-directed learning and the development of students’ lifelong learning skills. As part of this revision of undergraduate medical education, the GMC also revised its visiting policy to medical schools. Whereas previously it had largely left Universities to themselves, it now visited medical schools regularly to check on their implementation of the changes discussed in Tomorrows Doctors. Some observers highlighted that they were initial doubts over the effectiveness of these visits (i.e. Moran, 1999). However, in the last five years the GMC has substantially changed its earlier visiting policy. Due in part to reforms to the GMC itself, but also because of the developing role of the Quality Assurance Agency for Higher Education since 1997.

The Central Issue of Continuing Medical Education

The development of lifelong learning skills amongst a new generation of medical students was seen as important within the profession given the increasing political focus on doctor’s continuing competence to practice. An additional factor influencing medical school reform was that by the early 1990s the state had set up an advisory committee to look at medical workforce issues, which in itself indicated that the GMC was ‘losing control of the agenda of medical education’ (Moran 1999: 109). The reforms held in Tomorrows Doctors were undoubtedly part a reaction by the profession to the establishment of this advisory committee, as much as they was a recognition within the profession of the need to react to changes in the NHS and Higher Education. A government report in 1993 advocated reforms to junior doctor and specialist training to bring it in line with European medical training (UK training was longer). It argued for more formal arrangements for post-specialist training, called variously continuing medical education (CME) or continuing professional development (CPD) (Calman, 1993). Calman followed this report with a further one on the topic of doctors continuing medical education. Here he argued that: ‘The case for CME rests heavily on the concept of confidence: clinicians must command the confidence of the patients they treat; of the public as a whole; of the hospital managers to whom they are accountable for the quality of service to patients’ (Calman 1994: 6).

This state of affairs made it clear to members of the profession that it was the state not the professions’ elite institutions which was looking seriously at doctors continuing competence to practice. A direct state attack on the principle of medical self-regulation was feared. In an editorial in the British Medical Journal (BMJ) Richard Smith (1993: 974) held that ‘The government is sidelining the GMC and with it the self-regulation the profession has enjoyed since 1858′. However, despite a global recognition amongst medicine’s elite institutions of the need to act little had actually been done. This raises the question: ‘What was going on?’ Although the GMC and the Royal Colleges recognised the need to act on the issue of doctors continued competence to practice, the ‘Royal Colleges were most interested in making sure the GMC did not stray seriously into their territory, into specialist training or CPD, or indeed act decisively on its statutory duty to co-ordinate all stages of medical education’ (Irvine 2003: 98). The Colleges had introduced more formal arrangements for CPD. They worked with the BMA and the state to establish mechanisms whereby sanctions were introduced for doctors who failed to gain CPD ‘points’ for completing college courses, such as exclusion from merit awards and the supervision of junior doctor training posts. However, these lacked the key sanction possessed solely by the GMC: removal from the medical register for non-completion of CPD. In summary, when medicines elites recognised something needed to be done, a tendency towards institutional inertia remained. Not least of all, because it’s exclusive cognitive identity advocates a form of mutual protectionism, which frowns on ‘breaking ranks’ and ‘whistle blowing’ (Stacey 1992, 2000).

There was pressure within the profession demanding that the GMC become more proactive and take up the challenge of underperforming doctors. This is particularly amongst general practitioners, but also from powerful ‘in house’ commentators such as Richard Smith, who was editor of the BMJ (i.e. Smith 1992). Reformers felt the GMC was too far removed from the needs of the profession. They wanted it to provide definitive leadership to its ‘rank and file’ members by forging a more open and accountable relationship with the public. One of these reformers, who was heavily influenced by the sociologist and GMC lay member Margaret Stacey, as well as the medical sociologist Margot Jeffreys, was a general practitioner called Dr Donald Irvine (now Sir Donald Irvine). He would be the first leader of the GMC to be a general practitioner since its foundation one hundred and thirty seven years previously. Irvine (2005:11) noted: ‘In 1995,1 stood for election as President of the GMC, on a programme of reform both of professionalism in medicine and the GMC itself. There were members within the GMC, both medical and lay, who believed that such reform of the GMC had to be carried out swiftly. Otherwise public confidence in the medical profession, and in particular in the system of professional self-regulation, for which the GMC was primarily responsible, could not be sustained’.

Medicine’s New Professionalism

The foundation stone of Irvine’s ‘new professionalism’ was the recognition that self-regulation was a privilege not an inherent right. Hence, the number of lay members of the GMC was increased to twenty-five, out of a then one hundred and four. He also advocated the establishment of clear standards that could be operationalised into outcomes for assessment. This led to the publication of ‘Good Medical Practice’ (GMC, 1995b), which listed the principle attributes of good medical practice under seven headings – Good clinical care, Maintaining good medical practice, Relationships with patients, Teaching and training, appraising and assessing, Working with colleagues, Probity and Health. While ‘Duties of a Doctor’ (GMC 1995a) placed respect for patients and the need to maintain clinical competence at the centre of medical professionalism. These documents were the first sign that the growing culture of standard setting and performance appraisal in the NHS was reaching medicine’s own professional institutions. A key part of Irvine’s reforms included the revision of the GMC’s new performance procedures, which involved developing appraisal instruments. These operationalized Good Medical Practice into key competency ‘domains’ whereby assessors could mark a doctor’s ‘on the job’ performance’. For the first time the GMC could look at the actual ‘hands on’ competence of underperforming doctors. The cost of this scheme, potentially between £6000 and £22000 for an individual doctor in need of remedial training and £530,000 in total per annum for the NHS, was however, an issue in some quarters (i.e. BMJ 1995). The scheme’s appraisal instruments were subsequently published in the academic journal Medical Education (Southgate 2001). The scheme was linked to the final part of Irvine’s reform agenda, which was the introduction of the periodic re-certification of doctor’s ‘fitness to practice’ to stay on the medical register (known as ‘revalidation’). But then Bristol happened and in the words of Richard Smith (1998), it became a situation where everything ‘changed, changed utterly’.

Bristol and Shipman – ‘All Changed, Changed Utterly’

The Bristol case involved the deaths twenty-nine babies and young children following elective surgery at Bristol Royal Infirmary. The three doctors involved were Mr James Wisheart, Mr Janardan Dhasmana and Mr John Roylance. Between 1990 and 1993 Mr Wisheart carried out a procedure to correct a heart deflect known as an atrio ventricular spetal defect, on fifteen patients, of whom nine died. His mortality rate was 60%. Dr Dhasmana’s morality rate for this operation of 10% was far lower and within acceptable limits. His problems started when he performed a highly complex procedure called an ‘arterial switch operation’. Of thirty-eight patients twenty died. The national success rate was 80-90%. Worried by the paediatric heart unit’s high mortality rate, a young anaesthetist Mr Stephen Bolsin wrote about his worries to Mr Roylance, Bristol’s Chief Executive. He referred the complaint to the Director of Cardiac Services, who happened to be Mr Wisheart. Mr Wisheart reprimanded Mr Bolsin for having written to Mr Roylance. Then Joshua Loveday would be operated on by Mr Dhasmana. Joshua’s parents were not told of the units’ high mortality rate or of the fact that the night before the operation Mr Wisheart had held a special meeting with the cardiac team, to discuss the operation. The Department of Health heard of Mr Bolson’s complaint and raised concerns. It requested an external review be undertaken of the unit’s morality figures. A subsequent report for the television programme Panorama contained pieces from staff saying that just before the operation they wanted to ‘take the baby and run’. They did not. Nor did they officially complain or try to stop the operation. Joshua died on the operating table and his parents asked questions. Subsequently, they and other children’s parents launched a local support group that complained to the GMC, which then began an investigation.

The case caught the attention of the public, doctors and government like none before it. Not only were the children’s parents not informed of the units’ high mortality rate but the doctors involved clearly demonstrated a lack of critical self-awareness and willingness to admit openly to mistakes and learn from them. Additionally, the case brought home to the public just what the culture of the medical club did to ‘whistle blowers’. Mr Bolsin suffered for his efforts to put patients’ welfare first. Indeed, he was ostracised by his peers and had to move to Australia to restart his career (Delamothe 1998). The media camped outside of the GMC headquarters for the 65-day hearing. They reported a case, which ‘was a once in a lifetime drama that has held the attention of doctors and patients in a way that a White Paper can never hope to match’ (Smith 1998: 1918). The GMC found Mr Wisheart and Mr Roylance guilty of serious professional misconduct and struck them off the medical register, but not Mr Dhasmana. This was because he stopped performing the arterial switch operation when he realised his morality rate was too high. The children’s parents and the media were incensed and demanded a public inquiry.

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