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Establishing Accreditation and Standards in Australia Print E-mail
The Quarterly 2011

 


This article was written by Dr. Susan Keam, derived from material presented by Dr Heather Wellington on Monday 6 September 2010 at RACMA/HKCCM 2010.


Introduction

"A standard is a published document which sets out specifications and procedures to ensure that a material, product, method or service is fit for purpose and consistently performs the way it was intended." - Productivity Commission, Improving Standard Setting and Laboratory Accreditation, 2006.

Australian standard-setters include government departments, industry groups and Standards Australia. Standards Australia possesses the sole right to issue or accredit other organisations to write standards with the registered mark ‘Australian Standard’ and plays an important role in the processes through which many international standards are adapted as Australian Standards. The combination of a peak publicly-funded body and other private and public standard setters is typical of standard-setting infrastructure in many countries.

A range of standards and guidelines developed by clinicians, managers and other authoritative groups applies in the Australian health care system. Examples include:

  • peer-based standards developed and implemented by the Australian Council on Healthcare Standards (ACHS) for use in its accreditation program in the acute hospital sector;
  • standards developed by the National Pathology Accreditation Advisory Council which are applied via an accreditation system administered by the National Association of Testing Authorities; and
  • standards for residential aged care, which have a statutory basis.

Provider organisations that offer a combination of services across several sectors (e.g. a combination of acute health, aged care and community-based services) often have to comply with different sets of standards which may have similar philosophy and intent but are expressed in different ways. Costs and the complexity of compliance can increase under these circumstances. The Australian Commission on Safety and Quality in Health Care is aware of this problem and is developing a single set of national safety and quality standards.

The purpose of standards in the health sector

Standards in the health sector can:

  • define conditions for quality
  • reflect peer views on structures, processes and outcomes that represent minimum, acceptable, good or best practice
  • guide organisations and individuals in service delivery and development
  • address information imbalances between consumers and providers (enable consumers to understand more about what they can expect from a healthcare system)
  • transfer information about better ways to deliver services
  • improve the consistency of services
  • provide regulators with a tool to meet policy objectives
  • be used within a voluntary or regulatory framework to influence behaviour

The development of standards is not a simple task, but even greater difficulty is often experienced in ensuring consistent implementation of standards in complex healthcare systems.

Types of standards

There is much debate in the literature about the types of standards that should be developed. Should they be input, process or outcome standards? Likewise, should they be minimum (compliance-based) standards, or should providers be challenged with best-practice/aspirational standards? Should standards describe a static situation, or should they have an improvement focus?

While continuous improvement has been and continues to be a focus of considerable interest to policy makers, consumers often have an expectation that somebody, somewhere is setting minimum standards of care. Equally, there is a consumer expectation that processes will be in place to ensure that health services comply with those standards. Increasingly, there appears to be an expectation that a balance will be struck between a compliance-based approach and an approach that challenges providers to continuously improve their performance level.

Skok and colleagues (2000) note that the notion of standards implies clear-cut criteria and fixed definitions of quality, whereas the notion of continuous quality improvement implies a continual process of self-examination and a never-ending search for improvement without a fixed destination. They suggest that the tension between these concepts – continuous quality improvement requires continual revision, standards require certainty – can be reconciled by the development of more flexible and less prescriptive standards.

A number of concerns have been raised about potential negative effects of standards of different types, including:

  • that input-or process-based standards will restrict innovation (with providers seeking only to meet the minimum standard)
  • that outcome-based standards will mask critical process flaws that will materialise at some future time. For example, if a process’ flaw creates a risk of a rare but catastrophic event (e.g. the risk of a rare and serious infection being transmitted from patient to patient), simply monitoring outcomes will not alert providers or consumers to the risk
  • that 'best practice' or 'aspirational' standards may be unachievable by the majority and therefore will be ignored.


Should standards be voluntary or mandated?

There is a plethora of overlapping standards in the Australian health care system. A key question for policy-makers, regulators and managers is whether standards ought to be voluntary or mandated. Central to this question is which approach is likely to result in the best outcomes for patients.

Voluntary standards can be powerful tools for quality improvement, depending on the circumstances in which they are introduced. Defining what should be done, however, does not always guarantee that it will be done. Legislating that a standard must be adopted, and establishing an inspection regime (for example, through a licensing approach) similarly may not guarantee success.

Mandating standards and achieving compliance can be particularly challenging in the public sector where government often has multiple roles including standard-setter, regulator and owner.

Even when compliance with a particular standard is mandated, verification and enforcement of performance can both be very challenging. For example, explicit standards for hand and skin cleaning were incorporated into NSW medical practice regulations for many years. Despite the regulatory force of these standards for hand and skin cleaning, the “Clean Hands Saves Lives” report of the NSW Clinical Excellence Commission, published in 2007, showed that doctors were the least compliant healthcare professionals (see graph below).



Recommendations from the Clinical Excellence Commission’s report included that further work should be undertaken to develop and implement strategies to increase hand hygiene compliance rates among doctors and stimulate their clinical leadership role in this activity (recommendation 3.5.4).

Linking compliance with standards (as assessed through an accreditation program) to the availability of public funding for a service has been adopted as a strategy in some circumstances. This arrangement has been applied to both residential aged care and Medicare-funded pathology services in Australia. There is consensus that it has worked extremely well to drive sustainably high quality in the pathology sector. Evaluations of the impact of accreditation on the quality of residential aged care services also generally are positive, although concerns about costs of compliance are aired frequently.

Barriers to compliance

It is clear, therefore, that one of the most difficult tasks we face with standards, whether they are written in law, published as expert guidelines or promoted as evidenced-based practice, is not their development but ensuring their adoption.

The National Institute of Clinical Studies has looked at identifying barriers to uptake of evidence. Usually, such evidence is reflected in published guidelines or standards. The report found that barriers to adoption of evidence-based practice may operate at different levels:

  • The innovation itself (may/may not be good or accepted).
  • The individual professional (may or may not agree with the standard, or may not understand it or have the means to implement it).
  • The patient (may not fit the situation the standard prescribes for).
  • The social context (in hospitals and healthcare services, there are hierarchies of power and control).
  • The organisational context.
  • The economic and political context (writing standards for which there are no financial means for implementation can challenge us).

Ayres and Braithwaite (2002) propose the following:

  • Most organisations/people will comply most of the time simply because it is the law.
  • Some organisations/people will only comply if it is economically rational for them to do so, having made judgements about cost, difficulties, alternatives and the potential consequences of non-compliance.


Ayres and Braithwaite describe a regulatory model where the objective is to place the majority of effort into encouraging cooperative compliance (because there are logical, professional or economic reasons to comply). However, the desired level of compliance will only be achieved if a range of enforcement mechanisms of graduated severity are available. Under this pyramidal model, the availability of enforcement mechanisms encourages compliance such that actual enforcement effort is rarely required. The objective is self-regulation, but the model depends on the availability of strategies to enforce compliance if self-regulation fails.

The authors suggest that a strategy based totally on persuasion and self-regulation will be exploited when organisations/people are motivated by economic rationality. While a strategy based mostly on punishment will undermine goodwill when people are motivated by a sense of responsibility, wastes resources on litigation better spent on monitoring and persuasion, and fosters a subculture of resistance and a game of ‘regulatory cat and mouse’. According to Ayres and Braithwaite, “punishment is expensive; persuasion is cheap”.

Ayres and Braithwaite also point out that it cannot be assumed that higher standards result in better compliance. Even with increased specificity and robustness of the standards, there may paradoxically be low levels of compliance. This occurs because the performance of those who comply will improve as standards become more stringent, but more organisations/individuals may elect not to comply if the cost of compliance is too high, thereby lowering overall performance. The authors suggest that: "To reject punitive regulation is naïve; to be totally committed to it is to lead to a charge of the Light Brigade. The trick of successful regulation is to establish a synergy between punishment and persuasion."

The tension between regulators and the regulated is well described by Brennan: "The problem, to put it bluntly, is that regulation often leads to strife between regulators and the regulated industry, and thus to frustration of the regulatory intent."


Examples of standards implementation in Australia

Aged Care Accreditation

The aged care accreditation system in Australia seeks to combine a compliance-based approach with a continuous improvement approach.

The foundation for this system is 44 outcome-based standards in four parts that are incorporated into quality of care principles, which are made by the Minister under s.96-1 of the Aged Care Act 1997 (the Act).

The first standard in each part requires the organisation to actively pursue continuous improvement. The remaining standards define expectations of inputs, processes and/or outcomes of care.

Standards are implemented via a direct compliance obligation included in the Act (section 54-1(d)) and via a legislative requirement for providers to be accredited by a government-owned third party agency, as a condition of receiving public subsidy for the provision of residential aged care.

The system generally is viewed as having resulted in a substantial improvement in the quality of care delivered to aged persons in Australia.

The National Standard for Credentialling and Defining the Scope of Clinical Practice

The Final Report of the Taskforce on Quality in Australian Health Care 1996 highlighted a gap in credentialling and scope of clinical practice processes in Australia. Subsequently, the Australian Council for Safety and Quality in Health Care commissioned a consortium to undertake a substantial program of research and analysis and develop a standard, which was endorsed by all of Australia’s health ministers in 2004. The standard provides a comprehensive description of structures and processes necessary to ensure clinicians’ credentials are verified and an appropriate scope of clinical practice is defined and implemented.

Although implementation initially progressed slowly, widely-publicised clinical governance failures at the Bundaberg Hospital, which ultimately resulted in the conviction of Dr Jayant Patel for manslaughter and grievous bodily harm, was a substantial catalyst for change in Australia. Incorporation of the credentialling and scope of clinical practice into ACHS standards and accreditation processes has also significantly supported its uptake. Most major public and private hospitals have now implemented the standard. Managing credentialling and scope of practice issues has now become routine, although the Chief Executive of the ACHS commented in 2007 that the quality of systems still varies significantly.

Conclusions

  • Standards in health care have proliferated but compliance is often incomplete.
  • Standards may focus on inputs, processes or outcomes.
  • Implementation of standards may be voluntary or mandatory, or compliance may be linked to funding.
  • There can be challenges achieving the dual outcomes of compliance with minimum standards and continuous improvement.
  • In the public system, where government owns, regulates and operates its hospitals, sanctions are difficult to implement successfully.
  • Accreditation is an important tool in the Australian health care system for assessing performance against standards. Achievement of accredited status may be linked to the availability of public funding for health care services.

A balanced strategy based on a multifaceted approach around cultural leadership, education, persuasion and sanctions for non compliance is likely to be most successful.
 

References

Australian Commission for Safety and Quality in Health Care. Standard for Credentialling and Defining the Scope of Clinical Practice. July 2004. Sydney New South Wales. http://www.health.gov.au/internet/safety/publishing.nsf/Content/a-zpublicationss-u/$File/credentl.pdf

Ayres I and Braithwaite J (1992) Responsive Regulation: Transcending the Deregulation Debate. Oxford University Press, New York

Brennan TA. The role of regulation in quality improvement. Millbank Quarterly, Volume 76, Issue 4, pages 709-731.

National Institute of Clinical Studies. Identifying barriers to evidence uptake. February 2006 Melbourne, Victoria. Accessed at: http://www.nhmrc.gov.au/nics/material_resources/resources/identifying_barriers.htm on 7th of April 2011.

Productivity Commission. Standard Setting and Laboratory Accreditation. Productivity Commission Research Report. 2 November 2006. Melbourne, Victoria. http://www.pc.gov.au/__data/assets/pdf_file/0012/11325/standards.pdf

Skok A, Swerrisen H and Macmillan J (2000). Standards and quality improvement processes in health and community services: a review of the literature. Published by Quality Improvement Council Ltd, Latrobe University. www.qic.org.au/Docs/Review_Report.pdf




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