111 Referral Standard: Clinical Safety Case Report

The NHS Digital Clinical Safety Group (CSG) operates a full Clinical Safety Management System (CSMS) that encompasses integration with Health Organisations and professional bodies. The CSMS considers the integration with the Information Standards Board and the process in which professional standards are developed in the CSMS framework. The Clinical Safety Management System has been applied throughout all phases of the PRSB 111 standard. This Clinical Safety Case has been developed in accordance with the requirements of DCB0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems – Specification [Ref1] and DCB0160 Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems - Specification [Ref. 2].

The essential structures of a CSMS have been implemented in this project by engagements with the following organisations:

• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• 111 Information Standard project board
• 111 expert user group
• Joint GP IT Committee
• NHS E&I Bookings & Referrals service team
• NHS Digital clinical safety group
• Digital Health & Care Wales
• RCP Patient and Carer Network

The first step to preventing harm to patients through the use of these standards is to ensure a good development process that results in systems which are fit for purpose. Activities that have been carried out to clarify and address this include:

• A Hazard Workshop carried out with input from stakeholders and potential users of any such system facilitated by the Clinical Safety Officer
• Production of a hazard log for the project further revised through consultation with stakeholders
• Review of the hazard log following online consultation on the headings and any safety risks associated with any of the headings
• Review of mitigation of risks as part of the development of the standard headings

This hazard log comprises:

• Hazard name and description
• Potential causes
• Potential patient safety impact
• Initial hazard rating including likelihood and consequence
• Dependencies and assumptions
• Proposed mitigation
• Revised hazard ratings

Risks were scored using the risk matrix and scoring tools shown in Tables 1 - 4 Appendix 2.

A summary of hazards identified, including those deemed implementation issues is included in the following section.

The suggested mitigations aim to address clinical safety in relation to the design of the structure and description of the content of the standard. Further mitigations will be required when the standard is implemented in clinical / IT systems.

We have flagged some risks relating to implementation in this report but expect that further mitigations will be identified as clinical risk assessments and safety cases are developed by vendors and healthcare organisations during implementation.