Clinical Safety Principles
Clinical safety is about promoting and helping to embed clinically safer working practice methods and proactive risk management for patient safety enabled by IT with consistent application across the NHS.
The development of the GP Connect specification is supported by a team of clinicians at NHS England. The clinicians are responsible for decision-making relating to requirements that have a clinical safety impact. A clinical safety officer oversees all the development of GP Connect products and maintains a hazard log through direct engagement and regular hazard workshops. Hazard workshops will include clinicians from outside of the GP Connect team, wherever possible, to provide a wider perspective on the assessment of clinical safety of the products.
The assurance and assessment of clinical risk in the development of consuming systems are outside the remit of NHS England. Therefore:
- all consuming systems MUST nominate a clinical safety officer
- this person MUST be a suitably qualified and experienced clinician
- the clinical safety officer’s role for the consuming system is to ensure that effective clinical risk management is carried out during the development and during any modification of health IT systems using the clinical safety framework guidelines:DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems
- the GP Connect consumer hazard log should be requested, reviewed, and used to highlight potential hazards that may be identified during the development of the consuming system
- hazards should be scored and mitigated and are the responsibility of the consuming system
- any new hazards should be identified, scored and mitigated
- during development, consuming system developers must ensure they have adequate input from clinicians who will be using the system
- when deploying the consuming system to an end-user organisation the consumer must make their hazard log available to the clinical safety officer of that end-user organisation to review
Who is responsible for clinical safety during the deployment, use and decommissioning of the consuming system in end-user organisations? The clinical safety officer in the end-user organisation is responsible for ensuring the safety of a health IT system in that organisation through the application of clinical risk management. This clinical safety officer will be responsible for sign-off of the system as safe to use in their organisation, using the clinical safety framework guidelines: DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
The purpose of this standard is to promote and ensure that effective clinical risk management is carried out by those health organisations that are responsible for deploying, using, maintaining or decommissioning health IT systems within the NHS.
The clinical safety officer should review the consuming system hazard log and identify any new hazards that could apply in the deployment of the system into their organisation. These hazards will need to be scored and mitigated to ensure they do not pose a clinical safety risk to the end-user.