If policymaking is to establish agreement between competing claims, this can only be done via compromise (Booth 1988). This agreement may be general and ambiguous, enabling the resulting policy to be flexible in scope and thus more likely to being open to interpretations (as was our exemplar 1990 blood policy). Policy derived from this methodology is adaptable to varied aims and interests and therefore more likely to be accepted.

On the flipside, research is precise in its attempt to provide clarity to inform policy decisions. It does this by taking a number of variables and examining them in a controlled and systematic manner but ‘rarely provides the breadth of vision policymakers require’ (Booth 1988:230). Obtaining an increased understanding of an issue may increase the difficulty and challenge in arriving at an agreed policy decision (especially where experience and opinion are major influences upon health policy development) (Bowen et al 2005). Hence policy and research derive from very different streams of thinking and methodological frameworks. The fluid and ever-evolving environment in which policy is created is a challenge for researchers. The appropriate entry points for evidence-based research into a policy process are rarely controlled, and they are not the same in all instances. Evidence rarely enters into the genesis of a policy proposal because there is a lack of empirical evidence outlining the best methods for effective knowledge transfer into the policy domain (Almeida & Bascolo 2006). There are also apparent or real inadequacies in the timeliness, quality and relevance of research (Innvaer et al 2002). Thus the current utilisation of research in both policy and practice is subtle and indirect.

Another theory contends that a lack of communication between researchers and policymakers is the major reason for the policy research gap (Meyer et al 2006). The ‘two communities’ theory maintains that research and policy players are two factions unable to realise the perspectives and realities of one another’s sphere (Innvaer et al 2002). Moreover, with communication lines weak, any endeavour to ‘pair up’ these spheres remains a significant challenge in part because of an absence of personal contact between key players within these domains and because of their mistrust (Meyer et al 2006). Other critics simply advocate the use of ‘[policy] user-friendly formats’ (Laupacis & Straus 2007) for research reviews. By this is meant that research should be brief and focused on validity, applicability and implementation.

A further concern stems from the recently developed pejorative phrase ‘policy-based evidence making’ (House of Commons Science and Technology Committee 2006:para 89) referring to government use or commissioning of research that supports an already-determined policy approach. Doctors in the UK, for example, disbelieve that the National Institute of Clinical Evidence (NICE), the organisation responsible for developing national guidelines, acts independently; 85% of UK doctors state that they would ignore NICE guidance if they thought it ‘was wrong’ – presumably based on the perception that tainted or biased evidence was used (McLoughlin & Leatherman 2003). Consequently, Culyer & Lomas (2006) advocate for transparent deliberative processes allowing policymakers to develop ‘evidence-informed’ decisions. While this might seem an ideal solution, NICE is considered an exemplar of deliberative processes (Culyer & Lomas 2006) but it is still not always considered credible (Milewa 2006).

In summary, while it is easy to suggest that closing the current gap between research and policy is essential for effective health policy development, there are barriers. Research and policy are two very different entities that struggle to align. A number of reasons may account for this difference: there is an overall paucity of policy relevant research; research is often considered to fail policymakers in its appropriateness and timeliness; and there is a lack of mechanisms to appropriately review, disseminate and implement research.

Safety and quality introduce special policy issues to health. These are often emotive, used by both politicians and healthcare professionals to achieve their policy aims as stakeholders, and, at times, to resist change. Healthcare is also the subject of intense media coverage, and in the UK the ratio of negative to positive stories in the print media has increased (Alia et al 2001).

It is customary to ascribe the origins of the quality and safety movement to the Harvard Medical Practice study (Brennan et al 1991), the Quality in Australian Healthcare Study (Wilson et al 1995) and the Institute of Medicine report ‘To Err is Human’ (Kohn et al 1999). However, public trust in Australia wavered after a series of high-profile public inquiries into failures in safety and quality of care, namely those concerning:

The processes, quality and balance of inquiries can vary. Often they take on the characteristics of a witch-hunt (Beckett 2002) as release of information leads to wider, damaging consequences where the innocent can be punished and an atmosphere of hysteria leads to false accusations. But public inquiries can also bring public catharsis (Walshe & Higgins 2002) and substantially alter public opinion (Brunton 2005), especially if they produce appealing and plausible interpretations of events to repair damaged social institutions (Brown 2003), if they become a lever for change (Walshe & Higgins 2002) or through regulatory reform (Quick 2006). Against this backdrop the safety and quality movement uniquely drives policy (Liang 2004) providing reasons to increase regulation (Mello et al 2005) and accountability, the latter often via clinical governance mechanisms.

The term clinical governance, introduced in 1998 (Donaldson & Gray 1998), describes an organisational accountability framework for improvement, to safeguard high standards and for excellence to flourish in clinical care. Many specific items have subsequently been added to this framework or ‘umbrella’. The NHS clinical governance support team (http://www.cgsupport.nhs.uk/about_cg/) states: ‘Underneath this umbrella are several key components and themes, all of which, when effective, combine to make up good clinical governance … each [element is] of equal value and importance … interdependent and mutually reinforcing.’ While the components in published lists vary, elements can be separated into the disciplinary devices of inspection and moralising devices designed to enhance collaboration (Iedema et al 2005). Inspectorial devices include: data generation and analysis; performance monitoring and management; accreditation; guideline and protocol production and implementation; and the close integration of clinical work data with financial data. Moralising devices include: open disclosure, no blame, a just culture, a safety culture, leadership, teams, collaboratives, consumer involvement and patient centredness.

The current blood circular introduces the notion of ‘obligations under clinical governance’. Clinical governance is a powerful policy framework able to comprehensively envelop all aspects of clinical care and work practices to engage frontline staff to control, direct and theoretically improve care. The multiplicity of devices under the umbrella of clinical governance assists policymakers in developing ‘dispersed and devolved systems of policy implementation, where mechanistic and “top-down” command-and-control processes are ineffectual’ (Flynn 2002:160). Clinical governance in the UK has been described as quite a fundamental shift in the relationship between the state and the healthcare professions (Flynn 2002). Employees are given responsibility for quality and self-surveillance, but performance is also monitored by managers via targets, incentives and sanctions. In Australia different structure and funding arrangements make clinical governance less visible than in the UK.

Embedding best practice is difficult (Greenhalgh et al 2005). Medical leaders alone have been unable to improve the quality of care (Dixon et al 2007) and mandating best practice via policy is seen as an alternative. In the 1990s policy directives were not accompanied by tools to implement or monitor uptake, and neither health services nor the health department had mechanisms in place to measure and evaluate policy uptake or effectiveness. Local health service managers were left to determine how policy was implemented, which, not surprisingly, resulted in a variety of processes and procedures across the entire system. Detailing policy specifications to overcome this variation has not been sufficiently successful, giving way to further attempts to enforce healthcare policy by regulation.

A further regulatory strategy commenced in the 1990s when contracts with services began to include performance targets for patient outcomes. These were later associated with sanctions, penalties and incentives. An extension of this strategy is contracting with individuals to achieve key performance indicators (KPIs), that is, requiring managers to meet clinical quality and efficiency targets. Types of accountability include financial accountability introduced in the 1970s (The ‘Cogwheel’ Reports 1967/1972/1974), and the introduction of pay-for-performance (P4P) schemes that link clinical and financial accountabilities. Nagel (2006:4) suggests that ‘the trend in public management is focused on outcome-based policy where public sector managers are held accountable for results and afforded more discretion as to the means of their achievement’. This approach, implemented widely in the US (see for instance the AHRQ resources at www.ahrq.gov/qual/pay4per.htm), is seen by McLoughlin & Leatherman (2003) as imperative to achieve improvements in care in the UK. Paying general practitioners in the UK to ensure basic management of chronic disease, for instance, has proven effective (Dixon et al 2007), albeit unexpectedly expensive. Queensland is trying a more limited approach via the development of clinical networks based on the Queensland Health Clinical Practice Improvement Centre (CPIC) (Ward 2006) that use clinical practice improvement payments to provide a financial incentive for good-quality care linked to performance against defined targets that requires networks to collect and report data.

Further, patient safety has been used to justify a push for so called ‘responsive regulation’ to replace self-regulation (Healey & Braithwaite 2006). Mello et al (2005:375) in turn call for ‘rational regulation’ arguing that ‘(p)atient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public’. Australian regulation is undoubtedly eclectic. The mix of accreditation, licensing and the requirements of private insurers and government departments is a duplicative, expensive and unreliable way of ensuring the safety and quality of healthcare. Other regulatory experiments in Australia include the Quality Systems Assessment (QSA) program that aims to provide evidence of assurance of compliance with policies, standards and guidelines and assessment of the level of development of a patient safety system, clinical quality improvement, improvement at a local, facility and systems level and the identification of future risks to patient safety (see www.cec.health.nsw.gov.au/moreinfo/more_QSA.html).

Individual inquiries into health services also bring increased regulation. The Health and Quality Complaints Commission (HQCC) was established in Queensland following the Forster Report (2005) into Bundaberg Hospital. This oversight body aims to guide health service providers about what is expected in the areas of monitoring and improving the quality of health services. Following its inception, the HQCC has released statutory standards under section 20 of the Act establishing a legal duty that ‘(a) provider must establish, maintain and implement reasonable processes to improve the quality of health services provided by or for the provider, including processes: (a) to monitor the quality of health services and (b) to protect the health and well being of users of health services’.