111 Referral Standard: Clinical Safety Case Report

This document provides a clinical safety case for the 111standard project. The project has delivered information models, developed within the Art Décor open source tool suite (Art Decor supports the creation and maintenance of HL7 templates, value sets and data sets) and implementation guidance which will be used by IT suppliers and healthcare organisations to develop technical standards for structuring, coding and sharing 111 information, with a view

The PRSB 111 Referral Standard Clinical Safety Case to incorporating it into standard clinical IT contracts to facilitate improved access to health and care services via interoperability.

A total of 8 potential hazards were identified and mitigated. Of these 1 was scored at level 4 and 4 at level 3, these required additional controls to reduce risk to an acceptable level on the Risk Matrix (see table 1 below). After additional controls were put in place all hazards 3 and above were reduced to 2. The remaining 3 hazards were reduced to level 1 and 2 which were either acceptable where cost of further reduction outweighs the benefit, or no further action is required. The mitigated hazards include information that should be addressed by implementers.

All hazards were identified through the consultation steps carried out to develop these standards. The consultations consisted of a multidisciplinary workshop, online survey, review of draft information models and implementation guidance (by clinical informaticians and system suppliers) and an expert user group meeting. These workshops, surveys and communications included patient representatives as well as professionals from Royal College of Emergency Medicine, Urgent & Emergency Care, GP’s, allied health professions, health informatics professionals NHS E&I and IT vendors.

At each step of the consultation hazards were identified, reviewed and mitigations/actions considered. Nevertheless, some risk is inherent in the standards, but most has been:

(A) mitigated by the development of the standards

(B) or the residual risk has been transferred (with guidance) to the implementers.

Certain hazards were deemed system implementation matters. The hazard log (embedded within this document see section ‘Clinical risk management System’) provides guidance for system developers and implementers. It is important that this guidance in relation to these hazards becomes a requirement for implementation.

N.B: This clinical safety report is necessarily limited in its scope because it is neither directly related to software development nor to deployment. Suppliers developing software to implement these standards will therefore still be expected fully to apply DCB0129. Organisations involved in the deployment of such software will still be expected fully to apply DCB0160. This clinical safety case report is, however, a useful reference guide for any such projects.

The report has been overseen by the Clinical Safety Officer (CSO) for the project.