Managing your RDS toolkit in line with clinical and care governance principles

We recommend that you establish organisational and clinical leadership and accountability for your RDS toolkit in the following ways:

1) Practitioner leadership

Ensure that a senior clinical or social care practitioner lead is identified and named as the subject expert and champion for your toolkit.

2) Senior Responsible Owner (SRO)

Ensure that a Senior Responsible Owner is identified in your organisation. This is a requirement in the Part 1 toolkit request form.  A Senior Responsible Owner is an individual at a senior (usually Director or Associate Director level) who holds accountability on the part of the organisation for the quality and safety of the RDS toolkit.

3) Governance group approval

Ensure that an appropriate governance group approves delivery and ongoing development of the toolkit This is a requirement in the Part 1 and Part 3 toolkit request forms.

4) Organisation-wide governance for strategic development of RDS

Establish an overarching organisation-wide governance structure and process to oversee the creation and implementation of RDS toolkits within your organisation.  This will enable a strategic approach to toolkit development that supports organisational priorities. It will also ensure transparency and clarity about the role and contribution of RDS and how it is being used across the organisation.  

The examples below illustrate how some NHS Boards have designed their overarching governance structure and processes.

Examples

Here are some examples of the overarching governance processes in different boards in NHS Scotland:

NHS Lanarkshire

NHS Lanarkshire provides details within the RDS of its guideline submission and approval process . This includes the flowchart below showing the process for medicine and non-medicine related guidelines.

Process for the Development, Approval, Review and Monitoring of Medicine and Non-Medicine Related Guidelines.

This checklist includes the following stages:

• confirm that consultation has taken place with other relevant specialties
• confirm that guideline is new or replaces current or complements existing guideline
• confirm whether guideline is national or local
• confirm scope (acute/primary care/pan Lanarkshire/specialty or service)
• key Information - author, specialty/service
• last review date and next review date
• confirm that guideline is ratified
• complete submission form

NHS Greater Glasgow and Clyde

NHS GGC provides a clinical guideline toolkit which contains the NHSGGC Clinical Guideline Framework and appendices.  This framework sets out how NHSGGC develops, reviews, approves and monitors clinical guidelines.

This identifies three different stages of approval:

• eHealth Governance – toolkits are developed with NHSGGC Knowledge Services, part of the board's eHealth Directorate
• Wider NHSGGC Governance – all toolkits are approved and signed off by their local governance body or senior manager
• HIS Governance – toolkits are developed in accordance with national protocols and hosted on the national RDS platform, managed by NHS Health Improvement Scotland.

The following are examples of Boards' content management processes:

NHS Ayrshire and Arran

Governance Process.

This guidance sets out the governance process for NHS Ayrshire & Arran clinical guidelines, policies, procedures and pathways. It sets out the process to ensure clinical guidance is developed and agreed consistently, ensuring all key staff are involved and informed, and that the guidance reflects best practice. Furthermore, the process aims to ensure that clinical guidelines and pathways are kept under regular review and are up to date.

NHS Borders

Standards for Clinical Document Management Clinical Policies, Procedures, Protocols, Guidelines and Standard Operating Procedures.

Process for new clinical document development (page 10):

Process for clinical document review (page 11):

The Evaluate, monitor, maintain and improve section of the RDS implementation guide provides guidance on:

• Defining and applying an evaluation framework for implementation of your RDS toolkit or other RDS solution.
• Defining and using indicators to measure success.
• Producing a post-market surveillance plan
• Continuous evaluation and improvement of your toolkit.

The following elements of RDS toolkit management also support the clinical and care governance principles of quality review and improvement:

1.Content review and updating

This includes ensuring that you have a documented process and responsibilities in place for scheduled review and updating of RDS content. Publication and review dates and responsibilities should be recorded in the Editorial section of all content within the RDS.  This is a key requirement within the quality assurance checklist (Part 3 form for requesting a new toolkit) which all RDS toolkits are required to comply with prior to toolkit publication. Details of how to meet the requirement are outlined within the content management standard operating procedure.

2.User testing of RDS toolkits.

Tools and processes for usability and user acceptance testing are outlined in the Testing standard operating procedure. Involving users throughout the design and development process, and regularly gathering feedback through user testing, is key to delivery of decision support tools that genuinely meet user needs. 

The Right Decision Service implementation toolkit provides guidance on how to maximise clinical uptake and impact through design of your decision support tools, and through targetted implementation and spread methods. 

The implementation guidance highlights the importance of defining clinical objectives and indicators of success at the start of your decision support project. This will help to ensure that your decision support toolkit meets user needs and delivers the impact required.

The evaluation section of the implementation guidance provides more information on how to evaluate clinical impact and other levels of impact of your decision support tools.

All Right Decision Service tools should undergo a risk assessment prior to publication. You should maintain and update a risk register or hazard log which records risks, controls and mitigations and risk scores before and after mitigation. Requirements and examples are outlined in the standard operating procedure for risk management of RDS tools.

Note that Right Decision Service tools which are categorised as medical devices require to comply with the national and international clinical risk management standards associated with the Medical Device Regulations. Please refer to the standard operating procedure on Implementation of the Medical Device Regulations for more information.

Education, training and CPD are important for end-users of RDS tools and for creators of RDS tools - e.g. content editors, RDS toolkit leads.

You will find learning resources for end-users in the RDS Learning and support toolkit. The RDS also provides a competency framework for users of RDS tools. This competency framework covers:

• Key concepts of decision support, including knowledge-based decision support and data driven decision support including machine learning.
• Technical concepts including basic statistics, coding and terminology, logic and reasoning
• Ethnical user of decision support
• Soft skills
• Quality assurance and safety

The RDS also provides a suite of resources for providers of RDS tools, including tools and tips and videoclips for content editors. Introductory and refresher webinars for RDS editors are held on a monthly basis. Dates are published in the monthly RDS newsletter - accessed from the Announcements area on the RDS and from the Newsletter archive area.

Editors can also contact the RDS decision support team at his.decisionsupport@nhs.scot to organise 1-1 training on key RDS tools and features.

Post-market surveillance is the process of gathering and responding to user feedback, concerns and complaints. It includes addressing any clinical safety issues that arise as a result of using the decision support tool. 

Confirmation that you have processes and responsibilities in place to gather and respond to feedback and concerns is a key criterion within the RDS quality assurance checklist (Part 3 of the Requesting a new toolkit standard operating procedure.) 

Methods to capture post market data include:

• Analysis of usage data – for example, using the Google Analytics reports associated with RDS toolkits
• Keeping a register of issues, complaints or other departures from expectations
• Observation, interviews and meetings with users.
• Surveys of user satisfaction.

Implementers should explore any issues, complaints or concerns to understand whether they represent, for example:

• Misunderstanding of how to use the DSS
• Issues with design, bugs or performance of the DSS
• For DSS integrated with electronic health record systems, issues may be due to incomplete patient data or ineffective mapping of codes to the DSS.

Once the causes of problems are understood through these insights, appropriate actions can be taken.

The Right Decision Service implementation guidance emphasises the importance of stakeholder engagement and responsiveness from the earliest stage of your decision support project and throughout the development process.  Stage 1 (Identifying project goals and stakeholders) outlines suggestions for identifying key stakeholders and forming a guiding coalition. Stage 2 (Define the intervention and integrate it into user workflow) provides a section on user-centred co-design, requirements analysis and user research methods.

Please also refer to the sections above on quality review and improvement and on learning from feedback and complaints for further information on engaging with and responding to users throughout all stages of development and implementation. 

Use the quiz below to check your learning about managing your RDS toolkit in line with clinical and care governance principles.