About the Clinical Risk Management Training programme
This e-learning course has been developed by the Clinical Safety Team at NHS Digital in partnership with Health Education England e-Learning for Healthcare. It is designed to support health and social care organisations and manufacturers of Health IT products with training in the principles of safety, risk management and risk mitigation, all within the context of Health IT by implementing the safety standards, DCB 0129 and DCB 0160.
The safety standards provide a requirements framework that supports a systematic approach to clinical risk management during the development and use of Health IT systems. The standards establish the need for organisations to establish a clinical safety case to support the development and use of such systems.
The safety case is based on an appropriate hazard assessment, which is approved by a suitably trained and qualified clinician from both organisations
The ‘Community of Interest’ is an area where people can find knowledge and share good practice. This is aimed at individuals working within Health IT, this includes manufacturers and health organisations.
About the course
The core course, ‘Clinical Risk Management Training’, comprises seven sessions and one assessment session. The second module, ’Community of Interest’, is an area where people can find knowledge and share good practice. In addition to these two modules, we have two ‘Best Practice Guidelines’ sessions that are designed for health and social care organisations.
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Module 01
Clinical Risk Management TrainingModule 01
- Session 1 – Introduction to Clinical Safety and Safety Standards
- Session 2 – Clinical Risk Management System
- Session 3 – Clinical Risk Management Process: Activities
- Session 4 – Clinical Risk Management Process: Deliverables
- Session 5 – Hazard Assessment
- Session 6 – Deployment, Use and Decommissioning
- Session 7 – Clinical Safety Incidents
- Session 8 – Assessment Module
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Module 02
Community of InterestModule 02
- Session 1 – SMART
- Session 2 – Apps and Wearables
- Session 3 – Software as a Medical Device
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Module 03
Best Practice GuidelinesModule 03
Session 1 – Telehealth
Session 2 – Safety Critical Systems
Course supplement
The e-learning is supplemented by a 1-day class based course which will provide the knowledge and tools to support compliance with the safety standards and empower clinical safety officers to sign off and approve safety documentation.
Further details regarding our 1-day class based course can be found here.
Who can benefit from the course
The course is designed for clinical and non-clinical staff who need to gain an understanding of the clinical risk management activities undertaken during the design and/or implementation of a Health IT system to support the implementation of DCB 0129 and 0160. This includes clinicians, managers, developers and testers.
Healthcare provision and delivery within the NHS today is highly dependent on information technology, which provides sophisticated systems and services. Healthcare is an integrated and complex ‘system of systems’, with a patient’s care pathway being influenced by technology, different services, and the patient’s condition. Whilst the use of Health IT (HIT) delivers significant healthcare benefits, failure or unintended use of HIT systems undoubtedly has the potential to introduce hazards and associated patient harm. NHS Digital established a national safety management framework, which advocates a robust but light-touch approach, expending effort that is commensurate to the scale of risk.
Safety standards
NHS Digital has written and published two safety standards, one for manufacturers (DCB 0129) and another for health and social care organisations (DCB 0160). Each standard establishes a methodical approach to clinical risk management. The standards follow the approach established in the medical devices domain and are broadly consistent with ISO 14971. This ensures a consistent approach to clinical risk management is embedded within NHS England. A key concept in DCB 0129 and DCB 0160 is the promotion of establishing and maintaining a safety culture and management framework.
The risks associated with delivering complex care to larger client populations is increasing, as is the associated cost of indemnity and insurance. The NHS Digital clinical risk management system is proven to address these risks by developing a safety culture.
Project team
- Stuart Harrison – Head of Safety Engineering, NHS Digital
- Rudi Redford Brown – Safety Engineer, NHS Digital
- Neha Baj – Content Development Lead, HEE e-Learning for Healthcare
- Scott Mountifield – Project Manager, HEE e-Learning for Healthcare
- Alex Drinkall – Stakeholder Manager, HEE e-Learning for Healthcare
- Paul Butler – Senior Communications Manager, NHS Digital
- Hannah Jackson – Communications Officer, NHS Digital
Contributors
- Ian Tomlinson – Safety Engineer, NHS Digital
- Ian Dugdale – Safety Engineer, NHS Digital
- Sandy Garrity – Safety Engineer, NHS Digital
- Mark Thomas – Safety Engineer, NHS Digital
- Hannah McCann – Safety Engineer, NHS Digital
- Sean White – Senior Safety Engineer, NHS Digital
- Hannah McCann- Safety Engineer, NHS Digital
- Leah Hart – Clinical Safety Engineer, NHS Digital
- Andy Carr – Clinical Safety Engineer, NHS Digital
How to access
In order to access any e-LfH programme, you will need an e-LfH account. If you do not have one, then you can register by selecting the Register button below.
If you already have an account with e-LfH, then you can enrol on to the Clinical Risk Management Training programme by logging in to the e-LfH Hub, selecting My Account > Enrolment and selecting the programme. You can then access the programme immediately in the My e-Learning section.
Access for NHS healthcare staff in England
The Clinical Risk Management Training programme is also available to NHS healthcare staff via the Electronic Staff Record (ESR). Accessing this e-Learning via ESR means that your completions will transfer with you throughout your NHS career.
Further details are available here.