Implementation and Assessment to the National Clinical Trials Governance Framework

The Commission has developed an Assessment Framework for Safety and Quality Systems (the Framework) to improve the effectiveness, rigour and consistency of assessment to the NSQHS Standards. It incorporates a structured assessment method, which can be used when interviewing members of the workforce to comprehensively review the processes that make up the safety and quality systems specified in the Governance Framework.

Using a standardised structured assessment method allows assessors to comprehensively evaluate each component of safety and quality systems in a health service organisation. This provides a structure for conducting assessments based on evidence of actual performance from observations, interviews and records.

Fact Sheet - Process for accreditation to the National Clinical Trials Governance Framework

2022

Fact sheet or brochure

NSQHS Standards Using PICMoRS for quality improvement and assessment preparation

2020

Fact sheet or brochure

On-site and virtual assessments

PICMoRS is a mnemonic that was designed to help assessors to undertake assessment for accreditation under the AHSSQA Scheme. Originally developed for assessment to the National Safety and Quality Health Service Standards, it stands for:

• Process;
• Improvement;
• Consumer participation;
• Monitoring;
• Reporting and Systems.

When undertaking or participating in virtual assessments, accrediting agencies and health service organisations must follow guidance issued by the Commission in relation to virtual assessments.

Sampling of clinical trials operated by a health service organisation is required for all hospitals and day procedure services to be assessed against the actions in the Governance Framework.

To ensure consistency, the Australian Commission on Safety and Quality in Health Care (the Commission) has developed a sampling methodology, to be applied by all accrediting agencies, to health service organisations conducting clinical trials).

Fact Sheet - Sampling for clinical trials accreditation assessment

2022

Fact sheet or brochure

For the second and subsequent assessment cycles, a health service organisation is accredited if all actions in the Governance Framework are rated as ‘met’ or ‘met with recommendations’.

Accreditation is awarded for a period of three years. The date of commencement of the accreditation period is the date the accrediting agency formally notifies the health service organisation of the final outcome of the accreditation assessment.

Accrediting agencies are required to provide formal documentation to health service organisation as part of the accreditation assessment process. These include:

• Accreditation report
• Accreditation certificate (if a health service organistaion is deemed to have met all requirements of the specified standard)
• Testimonial.

The accrediting agency must include the following information in a testimonial that is to accompany the certificate of accreditation:

• Health service accreditation name
• List of each facility and health service address covered by the award
• For each listed facility or service, whether the applicable accreditation relates to announced or short notice assessment
• For each listed facility or service, the relevant standards to which the accreditation relates
• Date of commencement and expiration of the relevant accreditation cycle.
• Date accreditation is awarded.

If a health service organisation does not agree with their assessment outcome, an appeal may be submitted to their accrediting agency or directly to the Commission. It is strongly recommended that health services organisations exhaust all avenues of review or appeal with their accrediting agency before submitting an appeal to the Commission.

The Commission will only consider appeals where there is evidence that the relevant accrediting agency did not comply with Commission-specified policies, processes and/or directions relating to the assessment conducted.

An appeal, whether made to the accrediting agency or directly to the Commission, must be submitted within 20 business days of the health service accreditation receiving its final assessment report from its accrediting agency. Where an appeal is made to the Commission following an appeal to its accrediting agency, it must be made within 20 business days of the accrediting agency ruling on its appeal.

All appeals are to be in writing and submitted to the Safety and Quality Advice Centre via AdviceCentre@safetyandquality.gov.au

Supporting evidence and documentation should accompany the appeal.

• Submissions should include:
• Name, title and contact details of the person (with delegated authority) submitting the appeal
• Health service organisation name and address
• Name of accrediting agency
• Accreditation expiry date, if relevant
• Assessment date(s) relevant to the appeal
• Reason for submitting an appeal
• Evidence supporting the appeal.

On receipt of an appeal, the Commission will seek information from the relevant accrediting agency, and review the evidence provided by the appellant, accrediting agency and regulator (if relevant). The Commission will then establish a panel to review the appeal and make recommendations to the Commission’s Chief Operating Officer.

The Commission may do one or more of the following:

• Find any or all matters reviewed not substantiated
• Find any or all matters reviewed substantiated and make recommendations to the agency for corrective action
• Find any or all matters reviewed substantiated and take further action
• Find any or all of the matters reviewed substantiated but determine further action is not warranted under the specified circumstances.

The Commission will:

• Notify the relevant health service organisation and accrediting agency in writing of the outcome of the appeal, within five business days of the panel being convened
• Notify in writing the relevant health service organisation and accrediting agency of any action to be taken, together with the date of effect of that action

Once the Commission has issued a determination, there is no further avenue of appeal within the Commission.

Mediation is the process of an intervention to resolve conflict. Accrediting agencies or health service organisations may request the Commission mediate where there is a dispute regarding applications for not applicable actions and assessment outcomes.

Exemplar practices are real-world examples of health service organisations conducting clinical trial services that demonstrate best practice in the implementation of the Governance Framework. These services have safety and quality systems that are substantially higher than the general rating of ‘met’ for relevant standards or actions being assessed.

Approved accrediting agencies will be able to nominate health service organisations that have been awarded accreditation with all relevant actions rated as ‘met’ and are implementing an initiative that meets specified criteria. Initiatives considered as exemplars are:

• Designed to address a significant safety and quality issue
• Evidence-based or use best practice
• Patient-centred
• Clearly communicated to all relevant parties
• Embedded into day-to-day practice
• Regularly measured
• Sustainable
• Being appropriately evaluated
• Improving patient outcomes in the safety and quality of care delivered.

Submissions will be reviewed by the industry-based accreditation coordinating committee against specified criteria. Health service organisations that are formally recognised as exemplars will be issued with a certificate and have their case study published on the Commission’s website. This is intended to facilitate the identification and sharing of information on safe and good quality practice.

During the course of conducting an accreditation assessment, assessors may identify a significant risk. A significant risk is one where there is a high probability of a substantial and demonstrable adverse impact for a patient if it is not mitigated and is sufficiently serious to warrant an immediate response in order to reduce risks to patients. While the focus of reporting by assessors will be on significant risks of patient harm, it will not necessarily exclude other significant risks.

If one or more significant risks are identified during an accreditation assessment, assessors and/or approved accrediting agencies are to:

• immediately notify the health service organisation of the risk(s) identified
• discuss immediate action(s) to be taken by the health service organisation
• develop a plan of action to resolve or mitigate the risk
• notify the relevant authority and the Commission within 48 hours of identifying the risk

inform their clients and include relevant clauses in any contractual arrangements that information on significant patient risk will be provided to the regulators and the Commission when it is required by regulation or policy of a government agency.

From time to time, a health service organisation may wish to change the accrediting agency they have engaged to conduct accreditation assessments. Health service organisations should not be prevented from transferring between accreditation service providers. In these instances:

• The initial accrediting agency is the accrediting agency that currently provides accreditation services, and;
• The receiving accrediting agency is the accrediting agency that the health service organisation wishes to engage as their future accreditation service provider.

Health service organisations wishing to change their accrediting agency during their current accreditation cycle are able to do so, provided that they:

• Have signed a contract with the receiving accrediting agency prior to or immediately following cancellation of their client agreement with the initial accrediting agency
• Maintain the existing accreditation cycle and schedule of assessment
• Have no outstanding obligations to the initial accrediting agency.
• Any current accreditation certificates awarded by the initial accrediting agency will continue to be recognised by the Commission until the expiry date of the current accreditation award.

The receiving accrediting agency must not issue replacement accreditation certificates for the current accreditation award.

Accrediting agencies are required to advise the Commission of health service organisations that change accrediting agencies during an assessment or before an accreditation award is determined.

An Advisory is a formal communication issued by the Commission to accrediting agencies and health service organisations. Advisories provide guidance and direction on the interpretation and/or assessment of the Governance Framework under the AHSSQA Scheme. Advisories will usually be issued when the Commission identifies that additional support is required to assist with the consistent implementation or assessment of a specific action or topic. An advisory may also be issued where the implementation of an action requires a stepwise process with long implementation timeframes.

This course aims to support assessors in assessing service providers for implementation of the National Clinical Trials Governance Framework (review document prior to attempting course).

There are 4 modules in this course as listed below. An estimated time for completion is provided below:

1. Introduction to clinical trials (Completion time: 60 minutes)
2. Clinical trials regulation and legislation (Completion time: 30 minutes)
3. National Clinical Trials Governance Framework (Completion time: 90 minutes)
4. Assessing service providers to the Governance Framework (Completion time: 60 minutes)

Each module includes interactive content, knowledge check activities and ends with a quiz.

To access the course go to: NSQHS Standards orientation course