Background
Government, quality improvement and accreditation agencies frequently engage in the development or revision of clinical and organisational standards. These are significant tasks that utilise considerable human and financial resources [1]. Different organisations produce standards according to their own processes and requirements, and it is believed that inclusive processes result in greater acceptance of the standards produced [1]. However, we do not know what might be evidence-informed practice in the development or revision of accreditation standards [2]. To date, no empirical study has been published that sought to identify the process, resources and expertise required for either of these endeavours [2]. This is a significant gap in the evidence base for the healthcare accreditation field [2]-[4], as accreditation programs have increasingly become an important strategy by which governments seek to regulate healthcare quality and safety [5],[6]. There are now more than 44 health service accreditation programs which have been implemented in over 70 countries [3],[7].
The aim of this study was to identify and describe the process, resources and expertise required for, and to report evaluation outcomes from, a revision of a set of healthcare accreditation standards. The standards and associated revision activities under examination concern the Standards for General Practice (4th Edition) developed and revised by The Royal Australian College of General Practitioners (RACGP), which are used for accrediting general practice nationally. Through implementing an instrumental case study [8],[9] of the RACGP accreditation standards we sought to highlight the process, resource and expertise issues relevant for other accreditation standard setting bodies. The RACGP is representative of other bodies that similarly have responsibility for the development and revision of standards, but do not themselves apply or assess services using the standards [10]. Previous studies have revealed the common issues and challenges facing standard setting and accreditation bodies [7],[11].
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Methods
Study context
The Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork (ACCREDIT) was funded across 2011-15 to investigate health service accreditation in Australia [12]. The collaboration comprises university researchers, accreditation agency personnel and staff from leading quality improvement bodies in Australia (Table 1). The collaboration was awarded an Australian Research Council Linkage Project grant (LP100200586) in 2010. Ethics approval for the study was given by the University of New South Wales (UNSW) Human Research Ethics Committee (approval number HREC 10274). The ACCREDIT study protocols are publically available [12]-[15] and are informed by previous accreditation research conducted by UNSW and The Australian Council on Healthcare Standards (ACHS) [10]-[12],[16]-[24], including reviews of the healthcare accreditation literature [2]-[4].
Table 1
ACCREDIT collaborative partners
Partner category | Organisations |
|---|---|
University researchers | Centre for Clinical Governance Research, and Centre for Health Systems and Safety Research, in the Australian Institute of Health Innovation at The University of New South Wales |
Accreditation agencies | Australian General Practice Accreditation Limited |
Aged Care Standards and Accreditation Agency | |
The Australian Council on Healthcare Standards | |
Quality improvement bodies | Australian Commission on Safety and Quality in Health Care |
New South Wales Clinical Excellence Commission |
Setting
Australia has over 7,100 general practices in which more than 23,500 doctors work. There were 125 million consultation services provided during 2010-11, costed at A$5.3 billion through the Medicare Benefits Scheme [25] (this excludes out of pocket expenses of patients). In 2011-12 there were over 4000 general practices accredited against the RACGP Standards for General Practice [26]. The standards cover five areas: practice services (7 standards and 19 criteria); rights and needs of patients (1 standard and 3 criteria); safety, quality improvement and education (2 standards and 7 criteria); practice management (2 standards and 4 criteria); and physical factors (3 standards and 8 criteria). (See: http://www.racgp.org.au/your-practice/standards/standards4thedition/).
Study methodology
An expert group was formed by UNSW researchers and RACGP staff. During 2012, they collaboratively conducted a study with three stages. First, informed by the accreditation and evaluation literatures, the expert group purpose-designed an analysis framework with seven categories including: phase, task, objective, time frame, components, people involved and National Expert Committee - Standards for General Practice (NEC-SGP) involvement. The role of the NEC-SGP includes developing and maintaining standards for general practices, and ensuring that the standards reflect quality practice and are independent of government policies and initiatives. The NEC-SGP comprises experts in standards development with professional backgrounds including general practitioners, practice nurses and managers, and a consumer representative. Since 2011 the NEC-SGP is known as the National Standing Committee - Standards for General Practice. Second, using the framework, thematic analysis [8] of RACGP documents, minutes and evaluation reports related to the revision of the accreditation standards was conducted. More than 50 documents were accessed from the RACGP information system. Third, the group reviewed the findings to clarify the process, resources and expertise utilised, and reported evaluation outcomes. Over several months the expert group discussed the findings in meetings and electronic forums to work through the material, with differences resolved by negotiation [8].
Results
The analysis framework facilitated the identification of a standards review process comprising six sequential and overlapping phases with multiple components (Table 2). The six phases occurred over a 12 month period across 2009-10. Phase 1 comprised the `review methodology planning’ phase, which occurred over two months. This phase involved two tasks: developing the review feedback methodology and tools; and reviewing the evidence base for information on methods of standards development. The review of the evidence base and current standards were the tasks that formed Phase 2, which was completed over a five month period. Following Phase 1, and overlapping with Phase 2, Phase 3 was a five month activity requiring the development of new material for the new standards. The construction of field trial methodology, the sole task in Phase 4, occurred in parallel and was completed in two months. The completion of the initial four phases led to Phase 5 and the combined task of drafting, trailing and refining the new standards, which occupied five months. To complete the project, the final task was the formatting and production of the new standards. This was Phase 6 and occurred over a two month period.
Table 2
Analysis of the review process for the RACGP
Standards for general practices (4th edition)
Phase | Task | Objective(s) | Time frame | Components | People involved | National Expert Committee - Standards for General Practice (NEC-SGP) involvement |
|---|---|---|---|---|---|---|
1 Development of review methodology and tools | Develop the review feedback methodology and tools | Develop methodology to collect feedback from members and stakeholders on current standards | 1/09/09 - 30/10/09 | Review methodology of previous standards review | Senior Project Officer | Review documentation and meet |
Develop method of collection and analysis of feedback | Review and update draft tools | Secretariat | Decide on accepted review methodology (October) | |||
Recommend to NEC-SGP review methodology | Project Manager | Recommend review methodology to RACGP Council (November) | ||||
NEC-SGP (5) | RACGP Council ratify review methodology | |||||
Review the evidence base for current method of standards development | Ensure development of the new standards are supported by latest evidence | 1/09/09 - 30/10/09 | Literature search of methods of standards development and assessment | Senior Project Officer | Secretariat provide recommendations to NEC-SGP on methodology of standards development (October meeting) | |
Recommendations to NEC-SGP on how to develop and assess standards | Secretariat | NEC-SGP reviews evidence and accept recommendations on methodology of standards development (October meeting) | ||||
Council acceptance of methodology, timeline and cost | Project Manager | NEC-SGP recommends methodology, timeline and budget required to RACGP Council | ||||
NEC-SGP (5) | RACGP Council ratifies methodology of standards development process and approves budget (November meeting) | |||||
2 Reviewing the evidence base and the current standards | Review the evidence base for current standards | Ensure new edition includes material that is supported by latest evidence | 1/09/09 - 31/12/09 | Literature search of each criteria in current edition | Senior Project Officer | NEC-SGP decide on inclusion or exclusion of current criteria based on evidence presented (January 2010 meeting) |
Recommendations to NEC-SGP on latest trends relating to each criteria’s relevance to the next edition | Secretariat | Decide on membership of subcommittees and chairs; methodology and tools; new material (e.g. e-health, governance, IC, present material) | ||||
NEC-SGP (5) | ||||||
Review the current standards | All feedback on current edition is considered | 1/10/09 - 31/01/10 | Review feedback collected by RACGP since release of current edition | Project Manager | Secretariat provides analysis of feedback to subcommittees | |
New material for possible inclusion in revised edition is identified | Collection of feedback from members and stakeholders via focus groups, online surveys and written submissions | Secretariat | ||||
Analysis of feedback | ||||||
Recommendations to NEC-SGP and subcommittees on material identified from formal feedback | ||||||
3 New material development | Develop new material for new standards | Material included in new edition is evidence based | 1/11/09 - 31/03/10 | New material is matched with evidence - literature search relating to new material | Senior Project Officer | Secretariat draft new material |
New criteria, indicators and explanatory material are drafted | Senior Project Officer | Sub committees recommend changes to drafts, approve draft of new material and make recommendations to NEC-SGP | ||||
Project Manager | NEC-SGP accept recommendations of sub committees | |||||
Senior Project Officer | NEC-SGP approve draft of new material for trial | |||||
Working groups | NEC-SGP recommend draft to RACGP Council for endorsement for trial | |||||
Secretariat | ||||||
4 Develop field trial methodology | Develop field trial methodology | Prepare field trial of revised standards | 1/1/10 - 28/2/10 | Methodology of field trial of new material is described | Senior Project Officer | Secretariat design trial methodology and tools |
Trial tools are developed | GP research expert | Subcommittee approve to methodology and tools | ||||
Secretariat | Subcommittees recommend methodology and tools to NEC-SGP | |||||
NEC-SGP (5) | NEC-SGP approve trial methodology (April meeting) | |||||
NEC-SGP recommend methodology and tools to RACGP Council (April meeting) | ||||||
5 Drafting, trials and feedback about the new standards | Seek feedback, trial and refine draft new standards | Ensuring new edition of standards meet needs of RACGP and stakeholders | 1/4/10 - 31/8/10 | First line feedback groups provide an early indication of the feasibility and acceptability of proposed explanatory material and indicators to the working parties | Accreditation agencies (participant numbers not specified) | Subcommittees approve changes and recommend penultimate version to NEC-SGP |
On line survey for participation by all interested general practice professionals | Project Manager | NEC-SGP approves penultimate draft (July meeting) | ||||
Written submissions | Senior Project Officer | NEC-SGP recommends final Standards to RACGP Council for endorsement | ||||
Focus groups | Secretariat | RACGP Council endorses Standards (August meeting) | ||||
Trialling of draft standards through field trial (only new Criterion to be tested) | NEC-SGP (5) | |||||
6 Standard document revision and production | Format, produce and launch new standards | New edition of standards are produced and released to the sector | 1/9/10 - 4/10/10 | Ensure formatting of new standards is correct | Project Manager | NEC-SGP members, secretariat and key stakeholders present at launch |
New standards are launched during ASC 2010 | Senior Project Officer | |||||
Online version is made available | Publications/ IT | |||||
Complimentary copies sent to key stakeholders | Secretariat |
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Over 100 individuals substantively participated in the review process, with an additional 30 providing periodic input and feedback. Participants were drawn from general practice stakeholders, including: healthcare professional associations; primary healthcare services; accreditation agencies; government agencies; and public health organisations. Their expertise spanned the fields of: project management; standards development and writing; primary healthcare practice; quality and safety improvement methodologies; accreditation implementation and surveying; and research methodologies.
The review and development process was shaped by five factors. First, identifying and delivering upon the requirements of the RACGP, and stakeholders associated with the standards, was reported as necessary for the credibility of the product. Second, identifying and communicating resource and time restrictions to participants, and observers within the sector, was required to enable the review to be completed as expected. Managing expectations and employing an effective communication strategy reinforced a collaborative approach and facilitated broad stakeholder engagement with the review; these being the third and fourth issues identified as essential for a positive development process leading to the acceptance of revised standards. Finally, the review project had to deliver a well structured, clearly written, evidence based, high quality document that was consistent with previous editions. One significant improvement suggestion emerged from the evaluation: a majority of participants agreed that consideration could be given to altering the standards revision process to conduct periodic reviews and progressive updates.
Discussion
This study provides the first case-study evidence about processes invoked for the development and revision of accreditation standards [2], and lays the foundation for further work in this area [3],[4]. The research reveals that the revision of accreditation standards is a major undertaking requiring considerable resources and expertise, drawn from a broad range of stakeholders. Industry acceptance of the standards produced was found to be related to a collaborative, inclusive process, grounded by clinical evidence and process reviews, which promoted stakeholder participation. These findings support previously reported, non-empirical assessments, of how to approach the task [1]. For other accrediting bodies the study provides three things: insight into a difficult and challenging process; encouragement to investigate and make public their own experiences; and, a template and structure to follow to undertake such forensic examinations.
The project was completed through the combined efforts, or distributed leadership [19], of more than 100 people over a 12 month period. Key influences on the review process were: project requirements and stakeholder expectations; resource and time restrictions; collaborative team approach; stakeholder engagement; and the product required. The revision process necessitated the delicate balancing of these issues to maintain cohesion and continued participation between diverse and distributed stakeholders over an extended time period. Methodological rigour, as recognised by the six phases, was applied by the RACGP in the development, piloting and revision of materials. The commitment and effort of agency staff and committee members, who efficiently used resources with strict time constraints, enabled the efficient completion of the project. RACGP evaluation showed that stakeholder acceptance of the revision process and the revised standards produced was based on their perception of a transparent, inclusive and rigorous process implemented by the College [1].
Conclusion
The revision of accreditation standards requires collaboration from a diverse range of professionals, with considerable resources and expertise. The collaborative, inclusive process employed engaged stakeholders and promoted the acceptance of the revised standards by the sector.
Authors’ contributions
DG, RH, JW and JB conceived of the study, and participated in its design and coordination and helped to draft the manuscript. AD participated in the data collection and analysis, and along with AH and MC assisted in the revising of the manuscript. All authors read and approved the final manuscript.
Acknowledgements
This research was supported under Australian Research Council’s Linkage Projects funding scheme (project number LP100200586). The RACGP staff and members of the National Standing Committee - Standards for General Practice are thanked for access to documentation and contribution to this study. We also recognise our national and international collaborators for their contributions to the ACCREDIT project.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Competing interests
The authors declare that they have no competing interests regarding the publication of this article.