Governance

Governance is the shared responsibility of all service providers.

All units, hospitals, local health districts (LHDs) and specialty networks (SNs) must have governance and reporting processes to support sedation. This is in accordance with the requirements in the NSW Health Clinical Procedure Safety Policy (PD2025_006).

Hospitals, LHDs and SNs must also provide the appropriate resourcing to support safe procedural sedation. This may include facilitating and developing relationships between procedural departments and anaesthetic departments or other departments with expertise in sedation practice (where collaboration with an anaesthetic department is not possible).

When establishing a governance process, the scope of practice for clinicians (medical and nursing) should be determined locally in collaboration with procedural units and the anaesthetics department.

Where necessary, credentialing requirements should be identified, documented and implemented.

Accountabilities

Safe procedural sedation practice must be supported by the following:

• Clinicians are responsible for pre-procedure assessment, maintenance of skills and registration, addressing standards, and leading responses to, and reporting of, critical events.
• Unit managers are responsible for ensuring appropriate staffing, equipment and space are available.
• Manager or department head is responsible for ensuring the processes to support safe procedural sedation are followed.

Local policies on procedural sedation should be developed by LHDs and SNs.

The NSW Health Clinical Governance in NSW Policy (PD2025_032) outlines the requirements for effective clinical governance to ensure the best clinical outcomes possible.

Audit and review

Units and teams who regularly administer procedural sedation should have regular and effective audits of sedation-related outcomes. LHDs and SNs should review compliance with local policy, procedures and identified outcomes using 1% of procedures undertaken each month.

Reporting of all adverse outcomes relating to procedural sedation must occur through the ims+ process. This includes, but is not limited to:

• airway compromise requiring intervention
• abandoned procedures
• the need for emergency assistance (rapid response)
• unplanned overnight admission or unplanned admission to intensive care/close observation units
• use of reversal agents.

In particular, frequent use of reversal agents such as naloxone and flumazenil should be reviewed as a potential indicator of suboptimal sedation practice.¹

Local audits may also include patient complaints.

The results of audits should be discussed within the procedural team and inform ongoing training, education and support for all members of the team involved in administering sedation and the care of sedated patients.

Audit and feedback should involve oversight by, and communication with, an appropriate department, for example the clinical governance unit.

Reporting requirements

Clinicians who administer sedation must be familiar with their jurisdictional requirements for reporting all deaths that occur during sedation or within 24 hours following its administration.

Sedation-related deaths occurring beyond the 24-hour window must still be reported to the Special Committee Investigating Deaths Under Anaesthesia (SCIDUA), irrespective of when the death occurs, e.g. death on day five due to severe aspiration during sedation.

More information about the process for reporting to the SCIDUA can be found on the Clinical Excellence Commission website.

The NSW Health Incident Management Policy (PD2020_047) provides direction for managing and  responding to clinical and corporate incidents, and acting on lessons learned. This complies with the Health Administration Act 1982.

All staff are responsible for identifying incidents and for taking immediate action to ensure the safety of patients, visitors and other staff.

References

1. National Patient Safety Agency. 2008. Rapid Response Report: NSPA/2008/RRR011: Reducing risk of overdose with Midazolam injection in adults.