Book 2. Safety Quality Performance. The ACHS EQuIP5 GUIDE. Accreditation, Standards. Corporate Functions

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strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and The ACHS EQuIP5 GUIDE service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining Book 2 quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines Accreditation, Standards safety, quality performance strive for excellence framework for maintaining quality care and service focus on and the Guidelines customer developing strong leadership striving for best practice Support standards criterion guidelines safety, quality performance strive for excellence Corporate Functions framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive for excellence framework for maintaining quality care and service focus on the customer developing strong leadership striving for best practice standards criterion guidelines safety, quality performance strive Safety Quality Performance

The ACHS EQuIP5 Guide: Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions Published by The Australian Council on Healthcare Standards (ACHS) Copies available from the ACHS Publications Service Phone: +61 2 9281 9955 Fax: +61 2 9211 9633 Copyright The Australian Council on Healthcare Standards (ACHS) This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from The Australian Council on Healthcare Standards. Requests and enquiries concerning reproduction and rights should be addressed to the Chief Executive, The Australian Council on Healthcare Standards, 5 Macarthur Street, ULTIMO NSW 2007 Australia Recommended citation: The Australian Council on Healthcare Standards (ACHS), The ACHS EQuIP5 Guide: Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions. Sydney Australia; ACHS; 2010. The EQuIP Guide: First published 1996 Second edition 1998 Second edition revised 1999 Third edition 2002 Fourth edition 2006 Fifth edition 2010 5th Edition ISBN-13: 978 1 921806 01 8 (paperback) ISBN-10: 1 921806 01 X (paperback) ISBN-13: 978 1 921806 03 2 (web) ISBN-10: 1 921806 03 6 (web)

Contents Foreword 1 Introduction 4 Section 1 ACHS and accreditation 5 1.1 About the Australian Council on Healthcare Standards 5 1.2 What is accreditation? 6 Section 2 Overview of EQuIP 7 2.1 The EQuIP cycle 7 2.2 What is EQuIP? 8 2.3 The self assessment 8 2.4 Organisation-Wide Survey (OWS) 8 2.5 Periodic Review (PR) 9 2.6 EQuIP membership 9 2.6.1 ACHS EQuIP Certification Program 9 Section 3 EQuIP Surveys 10 3.1 The EQuIP Self-Assessment process 10 3.1.1 Benefits and objectives of the self assessment 10 3.1.2 The self-assessment process 10 3.1.3 The EQuIP Self-Assessment feedback report 11 3.1.4 Changes to the self-assessment format from EQuIP 4 to EQuIP5 11 3.1.5 Before starting a Pre-Survey Assessment 11 3.2 Pre-Survey Assessment (PSA) 12 3.2.1 How to start a PSA 12 3.2.2 The PSA format 12 3.2.3 Points to remember in preparing a PSA 15 3.2.4 The Electronic Assessment Tool (EAT) 15 3.3 EQuIP onsite surveys and processes 16 3.3.1 The survey schedule 16 3.3.2 Additional surveys 17 3.3.3 Getting ready for the survey one page summaries 18 3.3.4 Survey timetables 19 3.3.5 Surveyors meeting with the leadership team 20 3.3.6 The survey presentation 20 3.3.7 The survey process 20 3.3.8 Verification 21 3.3.9 The Summation Conference 21 3.4 EQuIP survey reports 22 3.4.1 How to use the survey report 22 3.4.2 Public release of accreditation information 22 3.5 Accreditation levels, survey recommendations and achievement ratings 23 3.5.1 Accreditation outcomes 23 3.5.2 Criterion achievement ratings 23 3.5.3 Expectations for ratings 25 3.5.4 High Priority Recommendations (HPRs) 26 3.5.5 Achieving accreditation 27 3.5.6 Non-accreditation 27 3.5.7 An appeals process 27 October 2010 249

Contents Section 4 How to use this EQuIP Guide 28 4.1 The EQuIP framework 28 4.2 Key changes in EQuIP5 29 4.2.1 EQuIP5 functions, standards, criteria 30 4.3 The criteria 32 4.3.1 Structure of the criteria (an example) 32 4.3.2 Mandatory criteria 34 4.3.3 Not applicable (NA) criteria / elements 34 4.4 Further information 34 4.4.1 Aboriginal and Torres Strait Islander people 34 4.4.2 Policies, procedures, protocols, guidelines and by-laws 35 4.4.3 Jurisdictions 36 4.4.4 Performance measures 36 4.4.5 Clinical indicators 37 4.4.6 National E-Health Transition Authority (NEHTA) 41 4.4.7 National Safety and Quality Health Service Standards (Australian Commission on Safety and Quality in Health Care) 41 Section 5 Standards, criteria, elements and guidelines 43 Book 1 Clinical Function (Standards 1.1 1.6) 43 Book 2 Support Function (Standards 2.1 2.5) 251 Corporate Function (Standards 3.1 3.2) 375 Section 6 6.1 Glossary and Acronyms Glossary (Book 1) 229 Glossary (Book 2) 463 Acronyms (Book 1) 245 Acronyms (Book 2) 479 6.2 Acknowledgements (Book 2) 482 250 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

Section 5 Standards, criteria, elements and guidelines 2.1 Quality Improvement and Risk Management Standard The standard is: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks. The intent of this standard is to ensure that the organisation: effectively manages all corporate and clinical risks in an integrated way continuously improves all aspects of the organisation and the services that the organisation provides. There are four criteria in this standard. They are: 2.1.1 The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. 2.1.2 The integrated organisation-wide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. 2.1.3 Healthcare incidents are managed to ensure improvements to the systems of care. 2.1.4 Healthcare complaints and feedback are managed to ensure improvements to the systems of care. Risk management is intended to reduce the threat of activities and processes going wrong. Quality Improvement is the action taken throughout the organisation to increase the effectiveness of activities and processes to provide added benefits to the organisation and consumers / patients. While risk management and quality management are distinct functions, a quality and risk management continuum exists. Quality and risk management programs must work together to achieve organisational goals and quality outcomes. Incident and complaints management is one strategy available to healthcare organisations for identifying, analysing and treating risks. October 2010 251

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion LA Awareness SA Implementation LA plus the following Criterion 2.1.1 The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. This is a mandatory criterion a) The governing body is committed to continuous quality improvement. b) A framework for continuous quality improvement exists. a) Quality improvement is planned, continuous and linked to the risk management system, education, and the strategic plan. b) Staff are supported and participate in ongoing improvement in care and service delivery. c) Leaders in quality improvement are identified and developed across the organisation, and supported to drive improvement. Intent The intent of this criterion is to ensure that all healthcare organisations understand the importance of the development of an improvement culture and system, and are able to demonstrate their commitment to continuous quality improvement in all aspects of care and service delivery. Relationships of 2.1.1 with other criteria This guideline should be read in conjunction with all other criteria. Organisational commitment To be effective, quality improvement must be fundamental to the way the organisation thinks about what it does. It should be embedded within the organisation s philosophy, practices and business processes, rather than viewed or practised as an independent activity. It is important that every employee is engaged in improvement efforts that are relevant and important for their work. Organisations should build in time for staff to participate in quality improvement (QI) as part of their daily work, and provide the necessary training, resources, flexibility and authority for staff to test processes and make improvements. 1 Without physician involvement in the process and a focus on consumer / patient care, quality management in clinical settings will remain difficult to achieve. 2 Many doctors have clearly become leaders in this area. However, some doctors see themselves as working for consumers / patients, and struggle to expand to their parallel role in working for an organisation. 3 Clinical leadership, arising from the governing body, is needed if quality management is to operate effectively amid the complexities of a healthcare environment. Leadership faces two challenges in implementing quality improvement continuously over time 4 : When a quality program is introduced, the major challenges will arise from building the participatory review process that is part of quality improvement. However, early in a quality program, big improvements are likely to be possible by correcting existing problems and then by introducing preventative measures. As the program matures, and systems become established, recurring problems will gradually be resolved and areas of high risk will be identified and may be mitigated. The challenge now is to lift the bar repeatedly to generate further improvement. Leadership remains imperative, because without ongoing commitment there is a tendency to forget the effort needed to maintain 252 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

MA Evaluation SA plus the following a) The effectiveness of the improvement framework and its component activities is evaluated and improved as required. b) Qualitative and quantitative data are collected, analysed and used to plan and drive improvement. c) Clinicians are involved in the evaluation of the quality improvement system. EA Excellence MA plus the following a) Comparison occurs with internal and external systems, and improvements to practices and systems are made to ensure better practice. and/or b) The evaluation of the effectiveness of improvement activities demonstrates excellence in improvement processes. OA Leadership EA plus the following a) The organisation demonstrates that it is a leader in continuous quality improvement. current levels of performance. This ongoing effort requires an embedded culture of striving for excellence, which is challenging to maintain, particularly if staff turnover is high. Leadership is fundamental to building such a culture. A commitment to quality improvement within the governing body may appear somewhat intangible, yet there are many ways that an organisation can demonstrate this. Consider: the use of key quality indicators by the governing body within their regular meeting structure inclusion of quality improvement in the strategic plan key staff appointments budgetary decisions ways that the organisation uses an accreditation framework in planning (EQuIP or other) the governing body s response to ACHS surveyors or other external consultants recommendations interactions with organisational councils, committees, or commissions responsible for monitoring and ensuring the effectiveness of quality improvement efforts participation by members of the governing body and support for organisational staff involvement in external quality activities, such as training programs, EQuIP surveying, voluntary reporting of performance data to external organisations, training programs with a quality focus, presentations of QI project outcomes at conferences, etc. using any (public) performance reports as opportunities to identify deficiencies and improve care, health outcomes, and consumer / patient satisfaction. Performance reports may include coroner s reports, the findings of a Royal / Special Commission, indicator reports, consumer / patient survey or focus group reports. Prompt points How does the governing body demonstrate its commitment to continuous quality improvement within the organisation? How does the governing body monitor and motivate quality improvement efforts and actions within the organisation? October 2010 253

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.1 The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. (continued) Quality framework, integration and use of data to drive improvement Implementing processes that assist an organisation to become a safe and accountable healthcare environment for consumers / patients and healthcare providers requires attention to systems and the analysis of collected data. Quality improvement and the management of risks in health care should be part of both strategic and operational planning in every area and service of healthcare delivery. Risk management and quality improvement should be considered when determining clinical practice, equipment design and procurement, personnel management and financial planning. 5 There are some essentials that characterise a quality improvement program irrespective of the QI framework used by the organisation, its size, type or complexity. It would be expected that: staff members accountable for taking action are identified and informed risk management and consumer / patient safety are considered in all decision making improvement teams are multidisciplinary quality activities are informed by appropriate data collection staff are familiar with quality objectives and processes, ideally through formal training, but in the absence of this, through orientation and mentoring there are channels through which concerns about quality of care and/or processes can be directed nationally identified and jurisdictional goals for the healthcare system are considered and integrated into planning. Quality improvement has been widely integrated into Australian health care since the 1980s. Quality improvement and risk management systems are directed to apply a structured framework for identification, analysis, action, monitoring and review for risks, problems and/or opportunities. Communication and consultation with stakeholders are critical for these processes to work effectively. EQuIP has been developed as a framework for assessing organisational performance against widereaching standards and criteria. Member organisations may choose to structure their QI activities around the same framework. However, although the EQuIP elements reflect the maturation of QI processes (awareness implementation evaluation and further improvement excellence outstanding achievement), this alone will not provide the tools to undertake a QI project in an area of concern. ACHS has developed the Risk Management and Quality Improvement Handbook 5 to support members in implementing QI and risk management within their organisation. The Guide is available to members at http://www.achs.org.au/riskmgmtqihandbook/. The handbook will introduce the many tools, skills, principles and frameworks available to conduct effective quality improvement projects. An organisation may be able to show that the words quality improvement appear within planning documents or educational programs. However, a higher level of evidence would demonstrate how the quality system was used to respond to an issue, by investigating risks and mitigating their impact. For example, staff who undertake activities where there are potential risks may benefit from an alternative approach, and this might require education or further training. If an identified high-risk practice were in widespread use, the organisation should have structured processes to communicate the proposed solution, train staff in adopting the new or altered practice and monitor the outcome of the change. 254 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

Evaluating the improvement framework itself will rely on a more qualitative examination undertaken at more than one level. Assuming the framework is being widely used, consider whether: it is used to tackle performance questions. If not, potential reasons may arise from organisational culture. Changing culture may be essential, but this is likely to be a long-term issue for senior managers. In the meantime, actions taken by the quality team might reduce the impact of identifiable factors such as inadequate leadership, inadequate time or resources, failure to gain multidisciplinary attendance at meetings, or to achieve outcomes from meetings. the organisation s improvement framework and processes work effectively across different types of quality issues. If not, organisations should consider the circumstances and reasons why the framework has not been effective. Have any changes been made in process, personnel or resources to refine the improvement framework and its operations? the actions taken as part of a QI project are followed up, measured, further refined, and the outcomes communicated to management. Where positive outcomes have been achieved, has the organisation initiated the same changes more broadly, or reported the outcome to similar organisations through a presentation, conference or journal? the strengths and weaknesses of the organisation s approach to quality improvement are known. Has the organisation s framework been compared to systems and processes used by other similar organisations? Prompt points Describe how quality improvement activities are initiated, organised and coordinated. Is there a central framework or committee to coordinate this activity? If so, what roles are played by the component parts? Describe the links between QI activity and the strategic plan? What links tie QI activity to risk management? When QI activity suggests the need for education, are there any links that would facilitate the provision of training? QI leadership, participation and support Leaders are not always titled personnel filling prominent roles. Quality may be the responsibility of a person with the title, Quality Manager, but achieving consumer / patient care that is safe and excellent is the responsibility of all clinical personnel, irrespective of their position in an organisational hierarchy. Guiding genuine change in consumer / patient care will require support and commitment from people working at an operational level. Among physicians, there are those who have earned the respect of their peers and can influence others. 6 Gaining buy in from opinion leaders will help to build up the momentum for change. Middle managers are key in disseminating and building a quality conscious culture. 7 They can translate strategy-level goals into actionable improvement at the department or unit level, engage staff in safety and quality improvement efforts, help determine which care processes need to be improved and how, and establish processes for spreading and sustaining improvement over time. 7 Organisational support may be overt or be built into a supportive culture. Organisations and managers can support identified leaders by: formally providing time for the management / coordination of QI teams / projects that have been formally recognised by management providing space (on websites, noticeboards, etc.) and leadership support for any notices or project recruitment efforts associated with quality projects recognising QI activity and outcomes in staff performance reviews supporting further education in quality and leadership through conference attendance, local workshops or funding to support further education supporting promotion of successful projects at conferences and awards formally acknowledging teams and their leaders in newsletters, staff meetings, and in other ways. The governing body and senior management are responsible for providing support for clinical staff to make and execute good decisions and improve healthcare performance. 8 Staff, consumers and other stakeholders should be informed about, and actively involved in, the organisation s safety and quality issues and improvement initiatives. 9 What processes / measures are used to monitor the quality of service provision? How is the QI system itself evaluated and improved? October 2010 255

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.1 The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. (continued) Review of the quality improvement system needs to include clinicians from the range of professional areas because: diverse training, consumer / patient pools and roles in care bring different perspectives to problem solving QI plans to resolve an identified issue may impact other areas of care the web of professional and systems linkages that facilitate care can be extensive and complex from the perspective of the consumer / patient, the clinicians are the public face of the organisation. Most organisations have teams or committees of clinicians that meet to consider outcomes of clinical care. Where a clinician expresses concern about a gap between desired outcomes and measured behaviours or effects, there is reason for further investigation. Awareness of gaps may come from internal or external sources, including: complaints from consumers / patients data on incident types and distribution an internal review following a serious incident or near miss external reviews such as Royal Commissions, coroners reports or ACHS surveys, or clinical indicator data. The involvement of clinicians 2 in such investigation management and risk mitigation is central to successful quality improvement programs. Wolff and Taylor have developed a checklist for engaging doctors in quality improvement and consumer / patient safety programs that might provide some useful focus points to improve engagement and participation. 2 Prompt points How does the organisation develop clinicians who will understand and lead in quality improvement? How does the organisation support its staff to participate in continuous quality improvement? What role do clinicians, particularly medical staff, play in quality improvement within the organisation? How are the outcomes of quality improvement reported back to the clinicians? Evidence commonly presented Consider whether the following will help to address criterion 2.1.1 Quality council / QI committee / improvement team membership that includes governing body leadership and participation Governing body agenda and minutes with reports of improvements, clinical and non-clinical performance, sponsoring of key improvement activities Strategic and operational plans, budgets that include quality improvement Governing body endorsement of framework for quality improvement Continuous quality improvement plans, frameworks such as philosophy, policy, improvement processes, performance targets, links to incidents, complaints, risks, education, planning Strategies for supporting staff to be leaders / participants in improvement activities By-laws, appointment criteria, position descriptions that include quality improvement responsibilities System for prioritising improvements to address high-risk, high-volume issues Reports of quantitative and qualitative performance data, clinical and non-clinical, and communication and distribution channels Minutes of meetings that discuss and action data 256 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

A list of improvements, clinical and non-clinical Evaluation of the improvement activities impact on the consumer / patient, organisation performance targets, cost versus benefit Evaluation of governing body, management and staff participation such as membership of project teams, number of activities Evaluation of the continuous quality improvement framework such as understanding and knowledge of the philosophy, policy, improvement processes, performance targets; improvements addressing high-risk, high-volume services; costs versus benefits Benchmarking activities, improved practices and systems assessment of organisational culture for quality improvement Performance measurement This criterion states that: The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. The organisation should be able to demonstrate that a framework for continuous quality improvement is embedded in all aspects of its operation, and that its quality improvement activities contribute to better service provision for its community, and better health outcomes. Some common suggested performance measures are as follows: Number of quality improvement activities that partially / fully achieve stated objectives Total number of quality improvement activities Comment: measurable objectives and a timeframe should be included in QI project plans at time of approval by management Number of quality improvement meetings with executive / senior management representation Total number of quality improvement meetings Comment: organisation to define executive / senior manager Number of consumers / patients involved in formal quality improvement activities Total number of persons involved in formal quality improvement activities Comment: organisation to define involvement October 2010 257

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.1 The organisation s continuous quality improvement system demonstrates its commitment to improving the outcomes of care and service delivery. (continued) Number of quality improvement activities / projects for which outcomes are currently monitored for the purposes of further improvement Total number of quality improvement activities / projects Number of quality improvement outcomes communicated to staff members not directly involved in the quality activity Total number of quality improvement activities Number of quality improvement activities formally acknowledged by the health service executive Total number of quality improvement activities Comment: depending on the organisation and its governance, formally acknowledged might involve management sign off on an activity or a report to a meeting of governing body or executive team Number of minutes of executive and governing body meetings that record recommendations / outcomes about quality improvement activities Total number of executive / governing body meetings held Number of improvements implemented in risk priority areas Total number of potential improvements identified in risk priority areas Comment: risk priority areas to be determined by the organisation; for example, risk priority areas could include severity assessment code (SAC) 1 and 2, or equivalent Number of clinical indicators that are better than the national peer group aggregate rate Total number of clinical indicators collected by the organisation 258 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

References 1. Riley WJ, Parsons HM, Duffy GL et al. Realizing transformational change through quality improvement in public health. J Public Health Manag Pract 2010; 16(1): 72-78. 2. Wolff AM and Taylor SA. Enhancing patient care: A practical guide to improving quality and safety in hospitals. Sydney NSW; MJA books; 2009. 3. Runciman B, Merry A and Walton M. Safety and ethics in healthcare: a guide to getting it right. Aldershot UK; Ashgate Publishing Limited; 2007. 4. Bishop A and Dougherty R. Implementing continuous quality improvement at the healthcare provider level. Lexington USA; Dougherty Management Associates; 2004. 5. Australian Council on Healthcare Standards (ACHS). Risk management and quality improvement handbook. Sydney NSW: ACHS; 2007. Accessed from http://www.achs.org.au/ RiskMgmtQIHandbook/ on 27 July 2010. 6. Reinertsen J, Bisognano M and Pugh M. Seven leadership leverage points for organization-level improvement in health care. Innovation Series. 2nd edn. Cambridge USA; Institute for Healthcare Improvement (IHI); 2008. 7. Federico F and Bonacum D. Strengthening the core: Middle managers play a vital role in improving safety. Healthc Exec 2010; Jan/Feb: 68-70. 8. Balding C. From quality assurance to clinical governance. Aust Health Rev 2008; 32(3): 382-391. 9. Victorian Quality Council. The healthcare board s role in clinical governance. Melbourne VIC; Dept of Human Services; 2004. October 2010 259

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion LA Awareness SA Implementation LA plus the following Criterion 2.1.2 The integrated organisationwide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. This is a mandatory criterion a) There is an organisation-wide risk management policy / guideline for corporate and clinical risks that identifies specific strategies for managing risks and is available to clinicians, managers and other staff. b) Clinicians, managers and other staff are informed about their responsibilities for identifying and managing risks. a) There is integration between quality improvement, risk management and strategic planning within the organisation. b) An integrated, organisationwide risk management framework addressing corporate and clinical risks is developed, documented and implemented. c) Systems are implemented to ensure clinicians, managers and staff can initiate action to prevent and/or reduce the impact of risks. d) A risk management approach is used when considering and developing new and modified services. Intent All activities of all organisations involve risk that must be managed. This is particularly true of healthcare organisations, where in addition to the degree of risk inherent to the provision of care there is community expectation of safety. The intent of this criterion is to ensure that the organisation identifies, minimises and manages its corporate and clinical risks via an integrated, organisation-wide risk management framework. Relationships of 2.1.2 with other criteria This guideline should be read in conjunction with all other criteria. Strategic planning, governance and risk management Risk is defined as the effect of uncertainty on objectives. 1 A healthcare organisation s objectives have different aspects, such as clinical, financial, health and safety or environmental, and they apply at the strategic, organisation-wide, unit, project and process levels. In the context of risk, uncertainty is defined as the state, even partial, of deficiency of information related to understanding or knowledge of an event, its consequence, or likelihood. 1 Any deviation from the expected can result in a positive and/or negative effect. Therefore, any type of risk, whatever its nature, may have either (or both) positive or negative consequences. Strategic planning is a continuous and systematic process whereby decisions are made by an organisation about intended future outcomes, how outcomes are to be accomplished, and how success is measured and evaluated. 2 A strategic plan should include a mission statement, objectives, goals, and an action plan. 3 Governance may be viewed as a guidance system for the achievement of an organisation s planned objectives, as defined within its 260 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

MA Evaluation SA plus the following a) The corporate and clinical risk management framework is evaluated and improved as required. b) Risk identification and risk analysis are undertaken using qualitative and quantitative data. c) Data from risk management processes are provided to clinicians, managers and other staff and improvements to care and services are planned and implemented. EA Excellence MA plus the following a) Components of the risk management framework are compared with internal and external systems and improvements are made to ensure better practice. and/or b) Evaluation of the risk management framework demonstrates that risk management is effective and risks are minimised. OA Leadership EA plus the following a) The organisation demonstrates that it is a leader in corporate and clinical risk management. strategic plan. Risk management is an integral aspect of governance, inasmuch as all objectives, whether corporate or clinical, will contain an element of risk, which must be effectively managed via strategies and controls, in order for those objectives to be achieved. 4 Risk management is a coordinated activity that directs and controls the organisation with regard to risk, while a risk management framework is the systematic application of management policies, procedures and practices to the activities of communicating, consulting, establishing the context, and identifying, analysing, evaluating, treating, monitoring and reviewing risk. 1 By associating the management of risk with all objectives, of all kinds and at all organisational levels, it becomes fully integrated as an organisationwide system, or risk management framework. This framework in turn ensures that information about risk derived from the risk management process is satisfactorily reported and used as the basis for future decision making and accountability. 1 The risk management framework should link to strategic and business planning and support assessment of new and/or altered services. For risk management to be effective it should 1 : create and protect value by contributing to the demonstrable achievement of objectives, and improvement of performance be an integral part of all organisational processes be a part of decision making explicitly address uncertainty be systematic, structured and timely be based on the best available information be tailored to the organisation take human and cultural factors into account be transparent and inclusive facilitate continual improvement of the organisation. October 2010 261

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.2 The integrated organisation-wide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. (continued) Risk management systems aim to support: achievement of the organisation s strategic goals protection of organisational assets (financial and physical) protection of human, and intangible, resources and property prevention of injury to consumers / patients, employees, volunteers and visitors reduction or mitigation of loss. Within the health system, an integrated strategy will include the management of both corporate and clinical risk; not only consumer / patient- and staff-related clinical risk, but also financial, human resources, occupational health and safety, environmental and asset-related risk. All such risks must be identified and integrated with the quality improvement system. Corporate risk management strategies may include: audit processes human resources planning political risk management implementation of financial management systems fraud minimisation schemes occupational health and safety strategies effective use of feedback from consumers / patients and staff staff education and training programs recruitment and retention strategies staff performance review and development. Clinical risk management strategies may include: clinical audit processes superior review, peer review and peer supervision credentialling and defining the scope of clinical practice for all clinicians (discussed within criterion 3.1.3) implementation of an incident management system that includes management of adverse and sentinel events (discussed within criterion 2.1.3) retrospective consumer / patient health record reviews effective use of clinical indicators mortality and morbidity reviews performance review and professional development. No one strategy is ideal for managing all risks. In order to be effective, organisations should undertake to implement a suite of the above-mentioned risk management strategies in accordance with the size of the organisation and the scope of the services provided. As part of this process, organisations should establish policy / guidelines and a system that: identifies analyses evaluates treats continuously monitors and reviews communicates... all corporate and clinical risks that occur, or that have the potential to occur, in a healthcare organisation, as well as delineating the specific strategies for managing these risks. A governing body-endorsed policy / guideline should be implemented that confirms the organisation s commitment to the management of risk, defines its risk management framework, and describes its principles, processes and specific strategies for achieving its objectives, and the responsibility of all staff for their implementation. This policy / guideline must be made available to all clinicians, managers and other staff. Prompt points How often is the organisation s risk management framework evaluated and, if necessary, improved? What prompts this re-evaluation? What processes does the organisation use to consult with its stakeholders about the management of risk? How is the organisation s risk management policy / guideline made available to staff? 262 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

Staff responsibility and involvement in risk management All staff at all levels have a role to play in the organisation s management of risk. This accountability should be made explicit within position descriptions 5, and discussed during performance reviews. 6 Staff should be informed during orientation of the organisation s processes for risk management, and further educated according to their role within the organisation as to their specific responsibility for identifying, evaluating and/or mitigating risk, and the steps by which any individual can initiate action in order to prevent and/or reduce the impact of risks. It should be emphasised that staff responsibility extends to all categories of risk, not clinical risk alone. The integration between quality and risk should be made evident, with discussion of matters that were initially raised as risk issues, but which through proper management led to improvement activities or to enhanced consumer / patient outcomes. Evaluation of the effectiveness of orientation and education programs should be undertaken to ensure that staff understand the risk management framework and their position within it, and improvements made as required. The organisation should strive to create a culture wherein active involvement of staff in the risk management process is encouraged and supported. Clinician engagement is critical to the effective management of clinical risk. Involvement of clinicians in risk management programs should be considered during credentialling and defining the scope of clinical practice. Other forums for clinician participation, according to the size and scope of the organisation, may be Medical Advisory Committees (MAC) or specialist groups. Data from risk management processes should be provided to all relevant staff, and used as the basis for improvements to care planning and services. Prompt points How does the organisation inform and educate its staff about their responsibilities in risk management? How does it determine whether these processes are effective? How does the organisation distribute the data gathered from risk management processes? How does it determine to whom the data should be provided? How does the organisation ensure that necessary changes identified during the risk management process are implemented? Risk management of new / altered services One of the most important aspects of an organisation s risk management framework is the assessment of a proposed new or modified service, for example, a change to an existing procedure, or the introduction of a new drug or diagnostic test. 7 The implementation of new or modified clinical interventions is governed at a State / Territory level, and these policies take a risk management approach to the process, with a view to reducing or preventing adverse events. The process by which an assessment of a new intervention is made, and the identity of those responsible for carrying it out, should be clearly delineated within the organisation s risk management policy / guideline; it will also comprise an aspect of the organisation s policy / guideline for managing credentialling and defining the scope of clinical practice 8, as discussed within criterion 3.1.3. The Royal Australasian College of Surgeons, through its Research, Audit and Academic Surgery Division, has issued General Guidelines for Assessing, Approving & Introducing New Surgical Procedures into a Hospital or Health Service 7, which where appropriate should direct the organisation s risk management of the introduction of new surgical procedures. The risk management process for a new or modified service should consider its clinical effectiveness and the potential advantages to the consumer / patient; any known risks and possible management strategies for them; how the consumer / patient will be informed of the advantages and risks; education and training of staff; and costs and cost benefits. 9 Upon introduction, the service must be carefully monitored and reviewed, and the gathered data used to evaluate and improve or eliminate it. What does the organisation do to encourage staff to participate in risk management? What resources does the organisation provide to facilitate clinician engagement in clinical risk management? October 2010 263

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.2 The integrated organisation-wide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. (continued) Prompt points What policy / guidelines were consulted in the development of the organisation s process for managing risk in the introduction of a new or modified service? How does the organisation assess the effectiveness and safety of a new or modified service? Evidence commonly presented Consider whether the following will help to address criterion 2.1.2 Organisation-wide risk management policy / guideline and procedures, endorsed by the governing body, that guide staff in the management and prevention of corporate and clinical risks, and that links with the quality improvement system Strategic, operational and business plans that consider risks Minutes of governing body, Medical Advisory Committee, medical staff council and staff meetings where risk issues were reported and actioned Budget allocation for risk management Tools for identifying and analysing risks Quantitative and qualitative data on identified risks such as incidents, Root Cause Analysis findings, clinical outcomes, staff injuries and budget variances Reports of the data on risks and on the communication and distribution channels used to reach relevant staff Improvements resulting from the analyses of risks By-laws, appointment criteria and position descriptions that include risk management responsibilities Clinician engagement in clinical risk management as an aspect of credentialling and defining the scope of clinical practice Evaluation of clinician, management and staff understanding of the risk management system ¼ ¼ Evaluation of the risk management system policy, risk identification, system for managing and preventing risks, communication of data on risks, use of data, high-risk, high-volume activities identified and improved, cost versus benefit 264 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions

Performance measurement This criterion states that: The integrated organisation-wide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. The organisation should be able to demonstrate its commitment to the creation of a culture in which risk management is recognised as the responsibility of all staff, where all aspects of the risk management system are regularly evaluated and improved where necessary, and in which the management of risk is an aspect of the organisation s continuous quality improvement system. Some common suggested performance measures are as follows: Number of improvements implemented in risk priority areas Total number of potential improvements identified in risk priority areas Comment: risk priority areas to be determined by the organisation; for example, risk priority areas could include severity assessment code (SAC) 1 and 2 rated risks, or equivalent Number of risk management goals / targets met Total number of risk management goals / targets Number of clinical indicators that are better than the national peer group aggregate rate Total number of clinical indicators collected by the organisation Number of new interventions and treatments introduced into the organisation Total number of new interventions and treatments subjected to risk assessment Number of clinicians actively engaged in clinical risk management Total number of clinicians Number of reviewed health records that identified a preventable adverse event Total number of health records reviewed Number of internal reviews of coroner cases / findings that related to the organisation Total number of cases referred to the coroner Comment: internal review is where the organisation formally reviews findings related to the organisation from cases that have been referred to the coroner October 2010 265

Section 5 Standards, criteria, elements and guidelines Standard 2.1: The governing body leads the organisation in its commitment to improving performance and ensures the effective management of corporate and clinical risks Criterion 2.1.2 The integrated organisation-wide risk management framework ensures that corporate and clinical risks are identified, minimised and managed. (continued) References 1. AS/NZS ISO 31000:2010 Risk management Principles and guidelines. 2. Blackerby Associates. Learn more about strategic planning in the not-for-profit and government sector. Phoenix USA. Accessed from http://www.blackerbyassoc.com/spdefine. html on 11 August 2010. 3. Special Libraries Association. Strategic planning handbook. Alexandria USA; Special Libraries Assoc; 2009. 4. Dahms T. Part 1: Risk management and corporate governance: are they the same? Risk Magazine 2008 (23 January). Accessed from http://www. riskmanagementmagazine.com.au on 11 August 2010. 5. Rural Infection Control Practitioners (RICPRAC). Infection prevention and control manual: section 10.1 risk management. 3rd edn. Melbourne; Victorian Dept of Health; 2008. 6. Maddock A. Risk management in practice: ERM in health care. Risk Magazine 2006 (14 September). Accessed from http://www.riskmanagementmagazine.com.au on 11 August 2010. 7. Royal Australasian College of Surgeons (RACS) and ASERNIP-S. General guidelines for assessing, approving & introducing new procedures into a hospital or health service. Stepney SA; RACS; 2008. 8. Australian Council for Safety and Quality in Health Care. Standard for credentialling and defining scope of clinical practice. Canberra ACT; Australian Council for Safety and Quality in Health Care; 2004. 9. Sweeney J and Cimoni M. Introducing a new procedure using a clinical governance framework: independent use of nasendoscopy to assess and manage swallowing and voice disorders. Austin Health; Melbourne VIC; 2005. Accessed from http://www.sapmea.asn.au/conventions/alliedhealth/ presentations/sweeney,%20joanne%20ah145.ppt on 12 August 2010. Guidelines Standards Australia. HB 254-2005:2005 Handbook: Governance, risk management and control assurance. North Coast Area Health Service, NSW Health. A new direction for the North Coast: Health services strategic plan. Towards 2010. Lismore; NSW Health; 2007. Further reading Dahms T. Part 2: Risk management and corporate governance: are they the same? Risk Magazine 2008 (14 February). Accessed from http://www.riskmanagementmagazine.com.au on 11 August 2010. Langley A. What does it mean when the risk assessment says 4.73 x 10-5? NSW Public Health Bulletin 2003; 14(8): 166-167. 266 The ACHS EQuIP5 Guide Book 2 Accreditation, Standards and Guidelines Support and Corporate Functions