Below, we have taken out the important arts of the COVID-19 vaccination programme guidelines for easy reading. The full document you can read yourselves down below clicking the link.
Proposed legislative change
16. We are planning to implement this policy through an amendment to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. We propose to insert the requirement as a new provision in the fundamental standards in Part 3 of the Regulations, most likely into regulation 12 (which deals with safe care and treatment) as a supplement to regulation 12(2)(h), which requires that, as part of providing safe care and treatment, providers must assess the risk of, and prevent, detect and control the spread of, infections, including those that are healthcare associated. We will also be amending the Code of Practice on Infection Prevention and Control and its associated guidance, which is issued by the Secretary of State under section 21 of the Health and Social Care Act 2008 and to which providers must have regard when complying with their obligations under regulation 12 of the Regulations. Draft amendments to the Code of Practice have been published alongside this consultation (see Annex A).
17. Due to the importance of this issue, we intend to change the law quickly. It is our current intention for workers in older adult care homes to be required to keep their COVID-19 vaccination status up to date. This will be kept under review.
Older adult care homes
18. The proposed regulations would apply to any care home which has at least one person over the age of 65 living in their home in England and which is registered with the Care Quality Commission. This is estimated to be approximately 10,000 care homes.
Persons requiring vaccination
20. It is our intention that the requirement to be vaccinated applies to all staff deployed in a care home supporting at least one older adult over the age of 65. This will ensure that vaccination coverage protects individual workers and people living in care homes and protects against the risk of outbreaks in the care home. This in line with advice from the SAGE Social Care Working Group.
21. This would include all workers employed directly by the care home or care home provider (on a full-time or part-time basis), those employed by an agency and deployed by the care home, and volunteers deployed in the care home. It would include those providing direct care and those working in care homes doing other roles, such as cleaners and kitchen staff. This is consistent with our approach to COVID-19 testing in care homes.
22. There is further consideration needed about whether we extend the requirement to include to those people who come to the care home to provide professional services, or other care and support. Arguably, this policy should extend to visiting professionals, in particular those who provide close personal care, such as health and care workers. It could also include hairdressers or visiting faith leaders. We are also carefully considering the situation of ‘essential care givers’ – those friends or family who have agreed with the care home that they will visit regularly and provide personal care. We understand that there are key considerations here for the range of people who may come into care homes and welcome your views in the consultation questions below.
23. We do not intend to extend this policy to friends and family members who visit people living in care homes – other than essential care givers, where we are considering carefully what approach is best. The SAGE Social Care Working Group has advised there is a balance to be struck between the risk of a loved one visiting and transmitting virus, against the wellbeing benefits to those who live in a care home. We would of course encourage friends and family members who are visiting the care home to access vaccination as soon as they are able however, as long as visitors carefully follow the advice in our guidance, we do not think it necessary to extend the requirement to family visitors. We welcome your views on this proposal in the question below.
Exemptions
24. There will be a small number of people where the clinical advice is that the COVID-19 vaccination is not suitable for them. We will ensure that the regulations allow for exemptions on medical grounds. The regulations will be drafted in line with the Green Book on Immunisation against infectious disease (COVID-19: the green book, chapter 14a) and The Joint Committee of Vaccination and Immunisation (JCVI) which reflect clinical advice. Individuals will be exempt from the requirement if they have an allergy or condition that the Green Book lists (Chapter 14a, page 16) as a reason not to administer a vaccine, for example prior allergic reaction to a component of the vaccine, including polyethylene glycol (PEG). Some individuals have an allergy or condition where the Green Book or the JCVI advises seeking medical advice, before proceeding with vaccination, where a professional medical opinion should be sought on whether the individual should be exempt. Both nationally and internationally, no concerning safety signals have been identified so far in relation to the vaccination of women who are pregnant. JCVI is continuing to review data on the risks and benefit of vaccination for women without significant underlying health conditions who are pregnant. As evidence becomes available, it will be reviewed, and advice offered as appropriate.
25. The government is considering the least burdensome way for people to demonstrate to their employers that they are medically exempt from vaccination.
26. The policy will be reviewed if significant obstacles would prevent eligible workers from accessing vaccination in a timely and accessible way, such as due to vaccine supply issues or changes in national clinical guidance. For example, this would mean that if supply issues make it impossible for a member of staff to access a vaccination within a reasonable travelling distance, the requirement will not apply to that individual until the supply issue is resolved.
27. The government will follow JCVI advice, which sets out that, as a precaution, it is preferable for under-30s with no underlying conditions to be offered an alternative to the Oxford/AstraZeneca vaccine where available.
Implementation
28. Care home managers are ultimately responsible for the safety of people living in their care. Under the proposed change to regulations, it would therefore be their responsibility to check evidence that workers deployed in the home are vaccinated, or medically exempt from vaccination. This means that workers would need to provide evidence to the manager that they have been vaccinated.
29. The government is carefully considering the best way for people to prove that they have been vaccinated to their employer. This may involve, for example, showing vaccination status on a mobile phone app.
The role of the Care Quality Commission
(Make sure you READ this part carefully)
32. It is our intention that this requirement would form part of the Fundamental Standards (set out in The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014) and would be monitored and enforced in appropriate cases, by the Care Quality Commission (CQC). It would apply to any care home that has any person over the age of 65 living there. Reported vaccination rates would form part of a suite of information CQC considers when determining which settings to inspect.
33. At time of registration and when inspected, care home managers would have to provide evidence that their workers are up to date with vaccination of an MHRA-approved COVID-19 vaccine.
34. In case of non-compliance with the legislation, CQC would take a risk-based and proportionate approach to enforcement, looking at all the evidence identified and whether the public interest test is met, in line with its enforcement policy. CQC has civil enforcement powers and in the most serious of cases, criminal enforcement against the provider or registered manager may be appropriate.
35. Civil enforcement options available to CQC include issuing: a warning notice, issuing a notice of proposal/decision to impose, vary or remove registration conditions, issuing a notice of proposal/decision to suspend or cancel registration, making an application to court for immediate cancellation of registration where there is serious risk to a person’s life, health or well-being and issuing an urgent notice of decision to suspend or vary conditions of registration where there is risk of harm to a person.
36. Regulation 12 imposes a requirement on providers and registered managers to provide safe care and treatment. This includes a requirement for the provider and registered manager to assess the risk of, and prevent, detect and control “the spread of, infections, including those that are health care associated”. This is supplemented by the Secretary of State’s IPC Code issued under s.21 of the Health and Social Care Act 2008. Where a breach of regulation 12 results in avoidable harm or a significant risk of avoidable harm to a service user, the provider or registered manager may be guilty of a criminal offence, and the CQC will look at whether to take criminal enforcement action. The maximum fixed penalty notice is £2,000 or £4,000, in respect of an offence committed by a registered manager or provider respectively.