Lee Rickles, Programme Director for the Yorkshire & Humber Care Record stated, “We have put the patient safety at the centre of the Yorkshire & Humber Care Record. To ensure we can provide high quality care we need to be able to provide secure high quality information in accordance with GDPR. We have just completed the clinical safety assessment for sharing patient information, ready for our first site to go live with patient information. The rest of this article explains the process and shares the clinical safety reports with the region and public.”
DCB 0129 and DCB 0160 are mandated NHS Standards published under the Health and Social Care act 2012.
Any Health Care IT system in England and any software relating to Healthcare IT is now part of the standards. From May 2020 the Medicines & Healthcare products Regulatory Agency (MHRA) will regulate the Medicines Device Regulation and standalone software is included. Therefore Clinical Safety is an integral part of the YHCR System of Systems (SofS) programme. For more information please see –
To ensure that the System of Systems is clinically safe there is an appointed Clinical Safety Officer (Rebecca Wilson), Clinical Lead (Dr Jason Broch) and a Clinical & Technical Design Authority (CTDA) group. YHCR is classed as the manufacturer of the product therefore is responsible for the DCB 0129 and also as the deplorer responsible for the DCB 0160. Any Trust/supplier/third party wishing to join the YHCR must comply with the standards DCB0160 and provide several key documents and assurances-
- A Hazard Log
- Clinical Safety Closure Report – please see download below
- Clinical Test Reports which must be reviewed and approved by their own Clinical Safety Officer
All of which is detailed in the Clinical Assurance Process – please see download below.
We have developed a Clinical Assurance Process, within this is detailed processes and stages that must be followed by both YHCR and any on-boarding site. This ensures that we maintain a high level of assurance from a clinical safety perspective. Detailed within the Clinical Assurance Process is a self-declaration form which essentially is a checklist to ensure anyone wishing to on-board with SofS are compliant with the mandated NHS Standards. This will also help on-boarding sites understand the various clinical activities and gateways to complete a satisfactory clinical safety assessment. We are proud to take clinical safety assurances to an in-depth level and ensure we are complying and continually looking at any changes that may arise. The CTDA have agreed and approved this process.
We have released our first Clinical Safety Case for Wave 1 SofS which details the YHCR programmes assurances from technical architecture, cyber security, service management, clinical testing and more. This document provides evidence to show all the various levels of testing, assurances and gateways passed by the SofS team to ensure the release of the system is clinically safe and also provides assurances to the on boarding sites. Incorporated in this is the programmes Hazard Log which details any hazards identified, our mitigations and this must be considered by any on boarding site and included in their own clinical assessment(s).It Is important to note this version 0.3 of the Clinical Safety Case is a working document and will change over time and is still in progress, we are working with NHS Digital’s Clinical Safety Team to ensure our Clinical Safety methods and reflections are as robust and accurate as possible. Clinical Safety is important to us as a programme, the patient is at the core of what we are doing so we must ensure patient safety is at the centre and no increased harm is created. The intended users of the SofS will be able to use and deliver a greater quality of care for these patients. Clinical safety will be continuously reviewed throughout the entity of this programme.
Any questions with regards to clinical safety please email firstname.lastname@example.org
Advance Notice – Clinical Safety Workshop for Social Care Practitioners and Clinicians – details to be confirmed – Jan/Feb 2020.