Assurance and regulation

Making safe and effective change

Making changes to health and social care services means considering the legislation, regulations, standards, and guidance that apply. These requirements help ensure services are safe, effective, and high quality.

This section explains the why this matters, who can help, what to consider, who you may need to involve, and where to find further information and support.

Why this matters

Legislation, regulations, statutory guidance, and standards are there to help you deliver safe and high-quality services. The purpose of regulation is to:

• Protect people who use services from the risk of harm.
• Ensure services meet high standards and quality is continually improved.
• Protect patient rights – the Patient Rights (Scotland) Act 2011 empowers patients to receive safe, effective, and person-centred care, including access to information.
• Ensure health and social care professionals maintain high standards of training and conduct, behaving ethically and professionally in line with recognised professional standards.
• Provide independent oversight and ensure accountability.

Complying with regulations, statutory guidance, and standards helps to ensure that people who use, deliver, and enable services are protected and that care is of the highest possible quality.

Working with regulators

Regulatory organisations such as Healthcare Improvement Scotland and the Care Inspectorate monitor compliance with legislation and regulations by conducting inspections or other quality assurance activity.

It can be helpful to think about regulators as enablers of change rather than enforcers of the law. External quality assurance processes and inspections can be seen as an opportunity to gain insights and recommendations about what is working well or not so well within your system. This learning can be used to identify opportunities for improvement and change.

When you want to make changes to a service, pathway, or health and social care system it is helpful to work alongside your regulator to think about how you might move towards more innovative ways of working while still meeting regulations, statutory guidance, and standards.

• It is important to understand that there might be different interpretations of how a regulation might be met – just because it has always been met in a particular way does not mean that this is the only way. Sometimes it may be possible to be flexible and proportionate in how a regulation is met.
• At times it may appear that there is a conflict between regulatory requirements, such as a tension between ensuring care is as safe as possible, while also making sure people who use services have choice and control over the care they receive. There is legislation underpinning both and no automatic precedence of one over another.

In these instances, contacting your regulator to work the issue through might be helpful.

Regulations should not be regarded as static and immovable. Sometimes, to make significant change, there is a need to update or amend regulations where there is strong evidence that this is the right thing to do. By working alongside regulatory organisations, it can be possible to find opportunities to change requirements without losing sight of what they were originally put in place to achieve, for example to keep people safe from harm.

Helpful tools and resources

The following tools can help you explore how legislation, regulations, standards, and local processes may affect your change, and identify opportunities to work differently while continuing to meet requirements.

Explore which requirements are set by legislation or regulation, and which are based on local custom, practice, or organisational policy. This can help identify where there may be flexibility to support innovation and change.

What to consider

When planning or implementing a change, it’s important to understand how it may affect different aspects of quality, safety, governance, and people’s experience of care.

Consider:

• Quality and safety – how will the change affect the quality, safety, and effectiveness of services?
• Workforce and staffing – are there implications for staffing levels, roles, skills, or training?
• Clinical governance and risk – have risks been identified, assessed, and managed appropriately?
• People and communities – how will people who use, deliver, and support services be involved?
• Human rights and inequalities – could the change affect people’s rights, access, or experience of services?
• Information governance – are there implications for data, privacy, information sharing, or record keeping?

This is not an exhaustive list. Additional considerations may apply depending on your organisation, service, and the nature of the change.

Who to involve

There are a number of internal teams or external organisations that you may wish to involve to ensure you have considered all the right things when you are planning or implementing a change. It is helpful to involve people (including those who use, deliver, and enable services, as well as local communities) as part of your change team as early as possible in the change cycle.

This might include:

Your regulatory body is there to help you deliver safe and high-quality services and will be happy to answer questions you may have when making changes to a service, pathway, or system of health and social care. It is better to ask, “this is the change I am making or the service I am reviewing, what do I need to think about?” than to wait for an inspection to identify potential areas for improvement.

As part of the understand step, it is important that you do additional research to identify other considerations that may be specific to your organisation or service. NOTE: This is not an exhaustive list.