Welcome to the next in the series focusing on the fundamental standards.
Some CQC fundamental standards focus on a particular aspect of care. Regulation 12 is different. It reaches into almost every part of a social care service because its starting point is simple: care and treatment must be provided in a safe way.
It is also one of the fundamental standards that CQC can prosecute against straight away if they have reasonable grounds. They do not have to issue a warning notice beforehand. So, it is a very important and far reaching fundamental standard that underpins a lot of activity within a service and could be seen as a ‘catch all ‘ regulation’ that allows CQC to act quickly if they need to act to protect people using services.
What it means for you
You must assess the risks to each person you support, do everything reasonably practicable to reduce the risks, and be able to show that you have done so. ‘Reasonably practicable’ is the important phrase. Regulation 12 doesn’t expect a risk-free service, and a provider who removes all risk by removing all choice will run into trouble elsewhere. Inspectors want proportionate, well-reasoned and well recorded decisions.
The regulation covers individual risk assessments, staff competence, safe equipment, medicines, infection prevention and control, and how you work with other services when care is shared or handed over.
CQC makes clear that this list is not exhaustive. Providers must demonstrate that they have done everything reasonably practicable to provide safe care and treatment.
It must also be noted that Regulation 12 appears very regularly in enforcement action. It rarely appears alone. Regulation 12 tends to describe the harm or risk, while the other fundamental standards explain how it came about.
How do the fundamental standards work together?
To illustrate how it may work in practice it might be useful to imagine an older man with dementia who has had two falls in the past month. His risk assessment and care plan weren’t reviewed or updated, the agency staff on duty over night when the third fall happened hadn’t worked at the home before and had not been made aware of the risks, and his sensor mat has been switched off because it ‘kept going off’. The fall resulted in a fractured hip and a hospital admission. The family was not informed of the incident, and a notification wasn’t submitted to CQC.
Breaking this incident down it could be seen as a Regulation 12 breach because a known risk was not managed. But follow the thread and other regulations appear. An assessment that wasn’t updated or reviewed raises issues under Regulation 9 (person-centred care). Agency workers with no induction raises issues under Regulations 18 and 19 (staffing and fit and proper persons). If nobody asked whether he could consent to the mat, Regulation 11 (consent) is engaged. If the manager writes ‘fall, monitor’ and nothing changes, that is a Regulation 17 (good governance) failure, and because he came to serious harm, Regulation 20 (duty of candour) requires the family to be told openly and promptly.
One incident, five or six regulations. Regulation 12 is where the consequences of weaknesses elsewhere become visible, and it is the regulation that underpins all the others as the result is that safe care and treatment were not provided.
What does this mean in practice?
For providers, this means having systems that work together rather than treating each part of Regulation 12 as a separate requirement.
For example, risk assessments should accurately reflect people’s current needs and be reviewed when circumstances change. They should then translate into care plans and clear instructions that staff understand and follow.
The same principle applies to staffing. It is not enough to show that staff have attended training. Providers need to be able to demonstrate that staff have the qualifications, skills, experience and competence required for the people they support.
Premises and equipment also need to be safe, suitable and properly maintained, with appropriate checks and servicing in place. Medicines need to be managed safely, with records, audits and competency checks providing evidence that the systems are working. Infection risks need to be identified and controlled through both appropriate arrangements and everyday staff practice.
Where care is shared with other professionals or services, safe care also depends on effective communication. Relevant information, changes in need and identified risks need to be passed on so that people do not fall between gaps in the system.
In each case, the evidence should demonstrate that the system works in practice, rather than simply that a policy or procedure exists.
The real challenge
Because Regulation 12 is so wide-ranging, it can easily become a compliance checklist. That misses the point. The real question is whether the provider has a safe system of care that identifies risks, manages them, learns when things go wrong and adapts when people’s needs change.
Regulation 12 may cover a lot, but its message is clear: providers must understand the risks involved in the care they deliver, take reasonable steps to manage them and be able to demonstrate that those arrangements work in practice.
Regulation 12 asks whether you know the risks facing each person and are doing what is reasonable to keep them safe, while respecting who they are and what they want.
Finally, it should be noted that Regulation 12 breaches start as weaknesses elsewhere. Providers who get the other fundamental standards right are far less likely to be in breach of this one. It won’t guarantee that nothing goes wrong, but it puts you in a much better position to spot risks early and show an inspector that you did what was reasonable.
Look out for the next instalment in our Fundamental Standards series covering Regulation 15: Premises and Equipment.