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Operational clinical safety process - Dean Mawson

Post go-live review


Summary

1. Representation

There should be representation from the health organisation and the supplier clinical safety teams including clinical safety officers, subject matter experts and any other relevant personnel.

2. Hazard log review

This is the best opportunity to review the hazard log post go-live including any new hazards that have been introduced by the risk assessment process. It is important that all hazard log references are documented against any development work and incidents that have been reported for clarity and consistency.

3. Lessons learnt

Once deployed, there is a need for the manufacturer to proactively monitor and review the achieved safety characteristics of the health IT system. This monitoring needs to extend beyond the health IT system itself to include the impact on users and related healthcare processes.
 

4. Clinical safety process outputs

Expected outputs at this stage of the clinical safety process which will be reflected in the risk management file.

Updated hazard log

Whilst the hazard log is a living document and continues to be updated during the lifecycle of the health IT system, a base-lined version is to be issued with each clinical safety case report.

Each version of the hazard log has to be reviewed and approved by the clinical safety officer to signify that the clinical safety information recorded is accurate and appropriate.

Safety case report

As part of the clinical safety management process any releases post go-live will need to be accompanied by a safety case report which will follow the same format as the previous reports. It may be the case that any release does not have any safety related incidents or issues that have been identified. Therefore an issued statement to this affect is satisfactory.

Further actions if required

Any actions that have been documented as part of the process will need to be given ownership and a timescale for completion.

Last edited: 20 November 2018 3:20 pm