Clinical Governance Standard

The governing body must assure itself that a culture of safety and quality improvement operates in the organisation.

• How does the governing body understand and promote safety and quality within the health service organisation?
• How does the governing body set strategic direction, and define safety and quality roles and responsibilities within the health service organisation?
• What information does the governing body use to monitor progress and report on strategies for safe and high-quality clinical care?

• Identify the governing body - this is the group of people or individuals with ultimate responsibility and accountability for decision making about safety and quality.
• Ensure that the roles, responsibilities and accountabilities for safety, quality and clinical governance within the organisation are clearly articulated.
• Review the organisational structure, and the position descriptions and contracts for managers, and ensure that roles, responsibilities and accountabilities for safety (including clinical safety) and quality are clearly defined and articulated at all levels in the organisation.
• Endorse the organisation’s clinical governance framework and strategic plans such as the safety and quality improvement plan, and the plan for partnering with consumers.
• Review the template or calendar for reporting to the governing body on safety and quality indicators and data, and ensure that it covers all services, locations, major risks, dimensions of quality and key elements of the quality improvement system.
• Regularly review quality indicators to ensure that they are relevant and comprehensive.
• Review relevant data from clinical incidents and reports of complaints and other incidents.
• Review the processes for providing feedback to the workforce, patients, consumers, and the community about the organisation’s safety and quality performance.
• Review the organisation’s audit program to ensure that it has enough safety and quality content.
• Ensure that mitigation strategies are in place to manage all major risks.
• Ensure that systems are in place to regularly survey and report on organisational culture.

The health needs of Aboriginal and Torres Strait Islander peoples are identified in partnership with local communities, and improvement actions are supported by the governing body.

• What information from the organisation’s performance, external sources, and the local Aboriginal and Torres Strait Islander community does the governing body use to identify and prioritise the specific health needs of Aboriginal and Torres Strait Islander patients?
• How are Aboriginal and Torres Strait Islander peoples involved in the governance of the organisation?

• Establish partnerships with local Aboriginal and Torres Strait Islander communities to identify priority health needs and any barriers to accessing health services.
• Endorse priorities and identified targets and have mechanisms in place to review strategies to improve the safety and quality of health care.
• Routinely review progress against Aboriginal and Torres Strait Islander safety and quality improvement strategies.
• Collect relevant data to inform planning and future decision making relating to service development.

The clinical governance framework is comprehensive and effective in improving safety and quality.

• Does the health service organisation have a documented clinical governance framework?
• How is the effectiveness of the clinical governance framework reviewed?

• Develop a clinical governance framework
• Educate the workforce about the key aspects of the clinical governance framework, and their responsibilities for improving safety and quality
• Review policies, procedures and protocols to ensure that they align with the clinical governance framework
• Review results of clinical audits and system evaluation reports for compliance with the clinical governance framework.

Strategies to improve the safety and quality of care provided to Aboriginal and Torres Strait Islander peoples are implemented and monitored for effectiveness.

• What strategies are used to improve outcomes for Aboriginal and Torres Strait Islander patients?
• How are these strategies monitored, evaluated and reported?

• Review data for Aboriginal and Torres Strait Islander patients relating to safety and quality outcomes, patient experience and engagement, and complaints
• Engage with Aboriginal and Torres Strait Islander patients and communities to review safety and quality information to set priorities for safety and quality improvement
• Implement, monitor and report on strategies to improve health outcomes for Aboriginal and Torres Strait Islander patients.

Decisions relating to equipment, plant, building works, consumables, staffing and other resources consider the safety and quality implications for patients.

• How are patient safety and quality issues considered when making business decisions?
• How are decisions about patient safety and quality of care documented?

• Review the organisation’s strategic planning and business planning processes to ensure that they explicitly capture safety and quality improvement strategies and initiatives, including those articulated in the organisation’s clinical safety and quality plan
• Review templates for submitting business proposals to the governing body and management, and ensure that they take account of impacts on safety and quality.

Clinical leaders and leaders of clinical services work with other clinicians to optimise the safety and quality of care.

• How do clinical leaders engage with other clinicians on safety and quality matters?
• How does the health service organisation ensure that the clinical workforce operates within the clinical governance framework?

• Define and allocate the delegated safety and quality roles and responsibilities of the clinical workforce.
• Conduct clinical audits to ensure that clinicians operate within the clinical governance framework.
• Report audit findings to the governing body.

The health service organisation has current, comprehensive and effective policies, procedures and protocols that cover safety and quality risks.

• How does the health service organisation ensure that its policy documents are current, comprehensive and effective?
• How does the health service organisation ensure that its policy documents comply with legislation, regulation, and state or territory requirements?

• Set up a comprehensive suite of policies, procedures and protocols that emphasise safety and quality.
• Set up mechanisms to maintain currency of policies, procedures and protocols, and to communicate changes in them to the workforce.
• Review the use and effectiveness of organisational policies, procedures and protocols through clinical audits or performance reviews.
• Periodically review policies, procedures and protocols to align them to state or territory requirements and ensure that they reflect best-practice and current evidence.
• Develop or adapt a legislative compliance system that incorporates a compliance register to ensure that policies, procedures and protocols are regularly and reliably updated, and respond to relevant regulatory changes, compliance issues and case law.

An effective quality improvement system is operating across the organisation

• How does the quality improvement system reflect the health service organisation’s safety and quality priorities and strategic direction?
• How does the health service organisation identify and document safety and quality risks?
• What processes are used to ensure that the actions taken to manage identified risks are effective?

• Define quality for clinical services (for example, effectiveness, safety, consumer experience) and share this information with the workforce
• Review the quality improvement system, including the vision, mission, values and objectives, to ensure that they reflect the organisation’s clinical safety and quality priorities, and strategic direction
• Decide how feedback will be collected from the workforce, patients and consumers
• Consider whether there is a coherent, planned and systematic schedule of audits of clinical and organisational systems, and reliable processes to capture findings and implement necessary improvements
• Develop a schedule for reporting to the governing body and managing the design and performance of key clinical systems
• Monitor and review progress on actions taken to improve safety and quality, and provide feedback to the workforce, patients and consumers
• Provide information and training, where necessary, to the workforce, patients and consumers to encourage their involvement in the analysis of performance data.

Health service organisations provide accurate and timely information on safety and quality performance to key stakeholders.

• What processes are used to ensure that key stakeholders are provided with accurate and timely information about safety and quality performance?

• Endorse a schedule of reporting that outlines the topic areas, format and frequency of reporting on safety and quality performance, and the effectiveness of the safety and quality systems
• Collaborate with the workforce, consumers, local communities and other health service organisations to identify the topic areas, format and frequency of reporting to these groups on safety and quality performance, and the effectiveness of the safety and quality systems.

The health service organisation identifies and manages risk effectively.

• How does the health service organisation identify and document risk?
• What processes does the health service organisation use to set priorities for, and manage, risks?
• How does the health service organisation use the risk management system to improve safety and quality?

• Review the organisation’s risk management system, and ensure that it is appropriately designed, resourced, maintained and monitored.
• Consider existing sources of information about patient safety, and whether more information is needed to reliably assess risk.
• Consider whether risk management orientation, education and training are adequately covered in the organisation’s education and training program.
• Ensure clear allocation of roles, responsibilities and accountabilities for maintaining the risk management systems and for performing the actions required.
• Regularly review risks and report on risk to the governing body, the workforce and consumers.
• Periodically review the effectiveness of the risk management system.
• Use a risk management approach to planning for emergencies and disasters that may affect the organisation’s operation or patient safety.
• Implement and monitor a risk register and review it regularly to ensure that:
  • it is kept up to date
  • it includes all relevant information
  • members of the workforce with roles and responsibilities in risk management use and maintain the register, and are accountable for actions required
  • risks are regularly reviewed, and reports are provided to the governing body, the workforce and consumers
  • plans exist to manage emergencies and disasters that may affect the operation of the organisation or patient safety.

Clinical incidents are identified and managed appropriately, and action is taken to improve safety and quality.

• How does the health service organisation identify and manage incidents?
• How are the workforce and consumers involved in reviewing incidents?
• How is the incident management and investigation system used to improve safety and quality?

• Implement a comprehensive incident management and investigation system for the organisation that:
  • complies with state or territory requirements
  • is appropriately designed, resourced, maintained and monitored
  • clearly designates responsibility for maintaining the system.
• Train the workforce about the risk management system
• Inform patients about how they can report risks or concerns.
• Implement a reporting and management framework to ensure that incident data are used to inform the governing body, the workforce and consumers to drive improvements in safety and quality.
• Periodically audit the incident management and investigation system to improve its design and performance, and to see whether it is adequately resourced.

An open disclosure process is used to enable the health service and clinicians to communicate openly with patients following unexpected healthcare outcomes and harm.

• How are clinicians trained and supported to discuss with patients incidents that caused harm?
• How is information from the open disclosure program used to improve safety and quality?

• Adopt and implement the Australian Open Disclosure Framework in a way that reflects the context of service provision.
• Ensure that members of the workforce who will be involved in open disclosure are trained.
• Periodically conduct audits that focus on the management of clinical incidents and consistency with the Australian Open Disclosure Framework.

Feedback from the workforce, patients and carers is used to improve safety and quality.

• How does the health service organisation collect patient experience feedback?
• How does the health service organisation collect feedback from the workforce?
• How are patient experience data and workforce feedback used to improve safety and quality?

• Implement a comprehensive feedback system that is appropriately designed, resourced and maintained to:
  • collect patient experience data
  • collect data on the workforce's understanding of safety and quality
• Describe the framework for reviewing feedback data from patients and the workforce, and incorporate issues identified into the organisation's quality improvement system
• Review reports on the analysis of patient experience data and the actions to deal with issues identified
• Periodically review the effectiveness of the organisation’s feedback system.

An effective complaints management system is in place and used to improve safety and quality.

• What processes are used to ensure that complaints are received, reviewed and resolved in a timely manner?
• How are complaints data used to improve safety and quality?
• What processes are used to review the effectiveness of the  complaints management system?

• Implement and maintain a framework for reporting complaints and incorporating issues into the organisation’s quality improvement system
• Implement a comprehensive complaints management and investigation system
• Review reports on the analysis of complaints data and the actions to deal with issues identified
• Implement processes to involve the workforce, patients and carers in the review of organisational safety and quality performance information
• Periodically review the effectiveness of the organisation’s complaints management system.

The diversity of consumers and high-risk groups are considered in the planning and delivery of care and services.

• What are the sociodemographic characteristics of the patient population?
• How do these characteristics affect patient risk of harm?
• How is this information used to plan service delivery and manage inherent risks for patients?

• Periodically audit the clinical and administrative data systems to identify the diversity of the patients using the organisation's health services
• Develop strategies to identify high-risk patients, and mechanisms to provide extra safety and quality protections for these patients.

Comprehensive, accurate, integrated and accessible healthcare records are available to clinicians at the point of care.

• How does the health service organisation ensure that clinicians have access to accurate and integrated healthcare records?
• How does the health service organisation ensure the privacy and security of healthcare records?

• Review the availability of healthcare records at the point of care
• Review the processes for maintaining confidentiality and privacy of patient information, including infrastructure, policies and workforce training for paper-based and digital healthcare records, and ensure that they are consistent with the law and good practice
• Review the design of the healthcare record to ensure that it facilitates documentation of the relevant clinical elements and clinical audit
• Ensure that systems are in place for data entry to clinical registries, if required
• Periodically audit the performance of the healthcare records systems, and improve them as necessary
• If multiple information systems are used to capture patient clinical information, periodically review the data systems to ensure that the processes for information capture are well designed, well resourced and working effectively
• Identify the individuals or committees responsible for the development, review and document control of forms, documents and files that make up the paper or digital healthcare record.

Health service organisations securely share a patient’s clinical information with authorised clinicians in other settings, including the My Health Record system.

• What processes are used to ensure that the health service organisation’s IT systems comply with the requirements of the My Health Record system?
• How does the health service organisation ensure that the workforce is appropriately trained in the use of the My Health Record system, including the use of identifiers and terminology?

• Use unique national identifiers for patients, clinicians and health service organisations in local information systems and in clinical documents loaded into the My Health Record system
• Implement standard national terms such as the Australian Medicines Terminology (AMT) in healthcare records and clinical documents loaded into the My Health Record system.

Clinical information held in the My Health Record system is accurate, complete and accessible by authorised clinicians.

• How does the health service organisation manage the policy implications and risks associated with introducing the My Health Record system?
• How does the health service organisation check the accuracy and completeness of clinical information in the My Health Record system?

• Develop, maintain and regularly review organisational policies for using the My Health Record system, to ensure that access follows the requirements of the My Health Records Act 2012External link
• Take reasonable steps to ensure that clinical documents provided to the My Health Record system are accurate at the time of loading, and that any amendments made to these clinical documents are also loaded into the system.

Members of the governing body and the workforce understand the approach to, and the roles and responsibilities for, safe and high-quality performance in the organisation.

• What information is provided to new members of the governing body and workforce about their roles and responsibilities for safety and quality?

• Review the organisation’s orientation policies and programs, and consider whether they provide appropriate and effective orientation in safety, quality and clinical governance.

The workforce is appropriately trained to meet the need of the organisation to provide safe and high-quality care.

• How does the health service organisation test the skills level of the workforce?
• What training does the health service organisation provide on safety and quality?
• How does the health service organisation identify workforce training needs to ensure that workforce skills are current and meet the health service organisation’s service delivery requirements?

• Review the organisation’s education and training policies and programs, and consider whether they provide appropriate and effective education and training in safety, quality and clinical governance.

Health service organisations provide a supportive environment and clear processes for the workforce to explore the cultural needs of Aboriginal and Torres Strait Islander patients.

• How does the health service organisation work to meet the needs of Aboriginal and Torres Strait Islander patients?

• Ensure that actions to improve cultural competency are implemented and monitored for effectiveness.
• Review the organisation’s education and training policies and programs to ensure that they adequately cover cultural competency and monitor workforce participation in training.
• Review and maintain the organisation’s targets regarding the participation of Aboriginal and Torres Strait Islander peoples in the health workforce across clinical, managerial, support and advocacy roles.

The health service organisation routinely reviews and discusses individuals’ performance and systematically collects information on individuals’ safety and quality training needs.

• What are the health service organisation’s performance review processes?
• What process is used to identify the training needs for each member of the workforce?
• How is this information incorporated into the health service organisation’s training system?

• Implement performance review processes for clinicians and other members of the workforce.

Clinicians are appropriately skilled and experienced to perform their roles safely, and to provide services within agreed scope of clinical practice.

• What processes are used to ensure that clinicians are working within the agreed scope of clinical practice when providing patient care?
• How does the health service organisation match the services provided with the skills and capability of the workforce?
• How does the health service organisation assess the safety and quality of a new clinical service, procedure or technology?

• Verify that the organisation has adopted and implemented an evidence-based process for defining scope of clinical practice for all clinicians, including those with independent decision-making authority or working under supervision
• Consider whether the process for defining scope of clinical practice is appropriately designed, resourced, maintained and monitored.
• Incorporate periodic review of the organisation’s process for defining scope of clinical practice into audit programs, with a focus on consistency with adopted standards, performance measures and outcomes.

A formal process is used to ensure that clinicians have the appropriate qualifications, experience and skills to fulfil their delegated roles and responsibilities.

• What processes are used to ensure that clinicians have the appropriate qualifications, experience, professional standing, competencies and other relevant professional attributes?

• Ensure that the processes for credentialing clinicians are documented in the organisation’s policies, procedures or protocols.
• Review results of audits and system evaluation reports for compliance with the credentialing policies, procedures or protocols.

Every member of the workforce understands and enacts their safety and quality roles and responsibilities.

• How are members of the workforce informed about, and supported to fulfil, their roles and responsibilities for safety and quality of care?

• Ensure that the governing body appropriately delegates responsibility for governance.
• Review the organisation’s performance development policy, and ensure that it incorporates leadership in safety and quality management and governance for all managers and clinicians.
• Review the organisational structure, position descriptions and contract templates of management, clinicians and other members of the workforce to ensure that responsibility for safety and quality is clearly defined at all levels

The clinical workforce is appropriately supervised as and when required to ensure the provision of safe, high-quality care.

• How does the health service organisation monitor and support clinicians to safely fulfil their designated roles?

• Identify clinicians who require supervision, including junior clinicians, clinicians in training, clinicians who are expanding their scope of clinical practice and clinicians who require oversight of their performance.

The clinical workforce is supported to use the best available evidence.

• How does the health service organisation decide which best-practice guidelines, integrated care pathways, clinical pathways, decision support tools and clinical care standards are to be used?
• How does the health service organisation support and monitor clinicians’ use of these tools?

• Evaluate the extent to which documented clinical guidelines or pathways have been formally adopted by the clinical workforce, and whether opportunities exist to adopt clinical guidelines or pathways as a quality improvement activity.
• Review how compliance with, and variations of practice from, evidence-based clinical guidelines or pathways are monitored, especially for high-volume or high-risk conditions.

Clinical practice levels of activity, processes of care and outcomes are reviewed regularly and compared with data on performance from external sources and other similar health service organisations.

• How does the health service organisation use both external and internal systems for monitoring and improving clinical and patient outcomes?
• How does the health service organisation interact with clinicians regarding their clinical practice and the health outcomes of their patients?

• Identify key external data collections, registries, audits or reports that cover the specific areas of clinical practice relevant to patients, or procedures or services offered by the organisation
• Support and encourage clinicians to participate in national and state or territory clinical quality registries
• In collaboration with clinicians, review clinical practice data from the organisation, and compare them with data from similar geographic areas or health service organisations
• Identify any areas of practice that vary from best practice, that show widely differing practice within the organisation or that vary from practice in similar services
• Investigate the reasons for any variation and identify whether it is unwarranted variation in the safety and quality of care
• Identify actions to ensure that practice changes align with best practice
• Consider issues of inappropriate resource allocation (including workforce) to ensure that practice changes align with best practice
• Identify any areas of risk and act to mitigate them
• Review the schedule of data and reports provided to the governing body and clinicians to ensure that they are comprehensive and relevant, and cover actions taken to align practice with desired care.

The physical environment supports safe and high-quality care and reflects the patient's clinical needs.

• How does the health service organisation ensure that the design of the environment supports the quality of patient care?
• How does the health service organisation ensure that buildings and equipment are safe and maintained in good working order?

• Regularly conduct environmental audits to see whether the environment is safe and promotes best practice
• Implement a schedule of review to ensure that all buildings, plant and equipment are fit for purpose, safe and in good working order at all times.

Aspects of the environment that can increase risks of harm are identified and managed.

• How does the health service organisation identify and manage aspects of the environment and other factors that can worsen risks of harm?
• What processes are in place to assess the appropriateness of the physical environment of the health service organisation for people at high risk of harm, such as people with cognitive impairment?

• Review the design of the clinical environment to identify safety risks for patients, carers, family and the workforce
• Conduct a risk assessment to identify service areas where there is a high risk of unpredictable behaviours, and develop strategies to manage identified risks
• Identify areas where patients could be treated that offer a calm and quiet environment.

Patients, carers and visitors can locate relevant facilities and services.

How do patients and visitors find the facilities to gain access to care?

Review the signage and directions provided throughout the facility.

Flexible visitation contributes to improved safety and quality of care for patients.

• What processes are in place to support flexible visiting arrangements?

• Review policies, procedures or protocols about visiting arrangements
• Ensure that infrastructure and supports are available to provide flexible visiting arrangements
• Monitor the effectiveness of flexible visiting arrangements.

Aboriginal and Torres Strait Islander people feel welcome and respected when receiving care.

• How does the health service organisation make Aboriginal and Torres Strait Islander patients feel welcome and safe when receiving care?
• How does the physical environment meet the needs of Aboriginal and Torres Strait Islander patients, carers and families?

• Establish relationships with local Aboriginal and Torres Strait Islander communities, and seek feedback on current practices in the organisation and areas for improvement
• Review the factors that create a welcoming environment for Aboriginal and Torres Strait Islander people.