Clinical safety management

Any incident raised by the customer is done through the service desk and is managed by application support. The workflow diagram below describes the process from identification through to mitigation/resolution.

The purpose of the safety incident management process is to: 

• enable users of the health IT system to report incidents they have had, or they consider may have an impact on patient safety, to the manufacturer
• enable personnel within the manufacturer’s organisation to report incidents they have had or they consider may have an impact on patient safety 
• provide a communication mechanism within the manufacturer’s organisation and where appropriate the health organisations that are using the health IT system 
• ensure appropriate and sufficient resources are allocated by the manufacturer to manage and resolve the reported incident  
• enable the manufacturer to issue safety alerts or bulletins to the health organisations to advise users of potential safety incidents and associated mitigation

To achieve this, the safety incident management process needs to provide the following:

1. A central point of contact (helpdesk) where the incident is logged.
2. A mechanism by which a clinical risk assessment can be made - in practice this will be the same criteria defined in the clinical risk management plan. As part of this assessment the existing safety case should be reviewed - ask questions such as:
   • does the reported incident constitute a new hazard? 
   • is the incident a realisation of a recorded hazard? 
   • have clinical risk controls failed? 
3. A mechanism by which the user community can be advised of the safety incident.
4. A mechanism through which effective root cause analysis can be conducted - this mechanism will need to consider the provision of appropriate resource and collaboration with appropriate organisations.
5. Corrective changes have been approved by the appropriate authority as identified in the clinical risk management plan.
6. Appropriate key point indicators to ensure effective management.
7. A mechanism by which the user community can be advised that the safety incident has been resolved.

Every release that is delivered to a health organisation must be accompanied by a safety case report if there are identified clinical risk issues that have been documented and managed as part of the risk assessment process.

At all times the release in question must be referenced in the report making sure all hazards are available to be reviewed if necessary.

If a release does not have safety related issues then a statement to that affect with evidence that the system has been tested satisfactorily will suffice.

To be updated

To be updated