Clinical Safety
- Toby Page
A Clinical Safety Case Report has been produced. This documents the scope, functionality, and clinical risk management activities in relation to LOOP (Leeds Online Open Platform).
The clinical risk management activities for LOOP have been undertaken in accordance with established guidance, hazards associated with LOOP have been identified and recorded within the LOOP Hazard Log.
The Clinical Risk Management Plan (CRMP) defines the implementation of, and any variation to LOOP clinical safety procedures. It describes how LOOP will conduct clinical risk management to ensure patient safety with respect to services provided and the interrelated and interactive activities that will occur to ensure that LOOP meets the requirements of DCB0129 and DCB0160.
In fulfilling this purpose, any variation to the standard practices and procedures to be followed, as defined by the Clinical Risk Management System (CRMS), when performing the activities of the programme are documented here in this document.
This CRMP identifies the means by which LOOP shall be controlled to ensure that the safety work is of high quality, conforms to the requirements of the CSMS and any specific programme requirements.
This document will be updated when the plan changes in any way as to deviate from what has been committed to deliver. This will be decided by the LOOP programme manager, LOOP project manager and Clinical Safety Officer and/or Team.
Background to clinical safety standards and requirements
Information standards provide the mechanism for introducing requirements to the NHS, those with whom it commissions services and its IT system suppliers. There are two Information Standards related to patient safety described below. These Standards can be found at:
DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems
This standard sets clinical risk management standards for manufacturers of Health IT systems. It requires the manufacturer to establish a structure within which clinical risks associated with the design and development of a new Health IT system or the modification of an existing system are properly managed. It also ensures that outputs are clearly documented to provide evidence of compliance. Compliance with the standard ensures that the manufacturer has instigated a best practice clinical safety programme during the manufacture of the health IT system.
DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
This standard requires health organisations deploying and using new or modified health IT systems to have a structure to manage clinical risks associated with that deployment. Many of the requirements in DCB0129 are repeated in DCB0160 for the health organisations.