Navigating the minefield of mandatory vaccinations in care home settings – where are we now?

As employees head back to work, some tentatively – some more enthusiastically, many organisations are returning to ‘business as normal’ or something resembling normal. Not so much for the social care sector. 

The Government’s drive for all care home employees to be vaccinated has resulted in hasty consultations and subsequent legislation going far beyond what most of us thought we would see in our lifetimes; legislation which has huge implications for this sector, its staffing, and its future in a society with a population in great need of affordable social care. 

The purpose of this ebriefing is to answer some of the questions clients have been asking about this new legislation, and provide some practical tips and information. The guidance to the rather sparsely drafted legislation is still very much a work in progress, and we will seek to provide further updates as things develop. For now, the information in this ebriefing is correct at the time of writing. We would therefore advise you sign-up to our further ebriefings or blogs (from Matthew Wort and Anna Dabek) to ensure you are kept up to date with changes as and when they arise. 

When was this legislation introduced?
The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 (the ‘Regulations’) were passed by the House of Commons on 13 July 2021, and approved by the House of Lords on 20 July 2021 and the guidance to the Regulations was published on 4 August 2021.

Who does it affect?
Anyone entering a CQC regulated care home in England, unless they are exempt, needs to have been double vaccinated as of 11 November 2021. A 16-week grace period was given by the Government to give care home providers time to apply the Regulations and assess the ramifications. 11 November marks the end of this grace period. The Regulations will apply to most people who enter CQC regulated care homes; staff, agency workers, contractors or self-employed individuals, CQC inspectors, doctors, nurses, volunteers, work experience students and job applicants attending an interview.

Who is exempt from the mandatory vaccination requirement?
The exemptions are essentially split into two groups; medical exemptions and other exemptions. 

Non clinically exempt people are as follows; current care home users and service users, friends and family of current care home users, workers who do not enter the care home i.e. gardener, post-delivery services etc, someone providing emergency assistance or urgent maintenance, members of emergency services who need to enter the care home, anyone visiting a dying relative and anyone giving bereavement support to a resident. 

Medically exempt people are those with conditions found in Chapter 14a of the Green Book on immunisation. Currently, it appears that only individuals with the following medical conditions are clinically exempt;

• A previous systemic allergic reaction (including immediate-onset anaphylaxis) to:
  • a previous dose of the same Covid-19 vaccine; or
  • any component (excipient) of the COovid-19 vaccine e.g. polyethylene glycol (PEG)
• Being acutely unwell (when vaccination should be delayed until you have fully recovered)
• Covid-19 (which would make them unsuitable in the short term in any event)
• Seriously debilitated by prolonged Covid-19 symptoms (when vaccination should be delayed and, in any event, is likely to make them unsuitable)
• A history of a previous episode of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2) where the Green Book indicates caution should be used
• A clotting episode with concomitant thrombocytopaenia following the first dose of AstraZeneca vaccine

The recent announcement from the DHSC however also seems to suggest that there is a further time-limited exemption available for pregnant women should they choose to take it. This is because they may choose not to be vaccinated whilst pregnant.

Further, individuals who have received a Covid-19 vaccination abroad also temporarily are considered medically exempt. This is because it is not clinically appropriate for them to be vaccinated in the UK if they have already received a partial or full course of vaccination overseas.

How will people demonstrate their vaccination status?
Evidence of vaccination can be demonstrated through the NHS App, the NHS website or the NHS COVID Pass letter. The NHS appointment card cannot be used. The care home where the individual is going doesn’t have to retain the evidence of vaccination. They only have to retain a record of the date the status was checked and the outcome of the check. This needs to be done only on the first occasion they attend the care home. On subsequent occasions, a check can just be made to ensure that the status was checked the first time. We would advise that, in accordance with Government guidance, care homes make a record of what checks have been seen and keep this with employment records, providing appropriate data protection compliance is in place.

How will people demonstrate their clinical exemptions?
The DHSC has recently (15 September) written to care home providers indicating that employees can now self-certify that they are medically exempt from vaccination. Please note that the letter does not comment on other persons entering care homes and therefore the position in relation to those individuals is not as clear. The letter provides a form that can be completed by an employee to self-certify that they are medically exempt (as set out above).

The decision to allow self-certification has clearly been taken in a rush and the communications contradict earlier messages from DHSC. The letter gives a non-exhaustive list of potential grounds for exemptions and also now provides that “a time-limited exemption is also available for pregnant women should they choose to take it.”

The self-certification form requires an individual to confirm that they meet the medical criteria “in this guidance”. However, the attempt to include a hyperlink within the form, to more information has failed, so what they mean by “this guidance” isn’t entirely clear. The form just includes examples of exemptions. For something so serious, this is very disappointing and creates further uncertainty. The form makes clear that “providing false information may result in disciplinary action”. However, the form itself doesn’t require someone to state what the medical criteria they are relying on is.

We consider providers accepting self-certification should be seeking information as to the medical exemption being relied on, so they can be satisfied that the self-certification is appropriate.

The self-exemption form is only valid for 12 weeks from the launch of the exemption process. This process was launched on 30 September, hence a certified exemption will be needed after 24 December 2021. From 30 September, the process for employees to apply for and receive their medical exemption has been live, as announced in last week’s press release. Employees will need to call 119 from 30 September and if they fit the criterion for medical exemption they will be issued with an application form. Once completed and sent back, this form will then be reviewed by clinicians and the results sent through to the individual within 2-3 weeks. Once an exemption is given, employees can use NHS Covid Pass either on the app or on the NHS website. We are still awaiting clarity as to the exact details of medical exemptions at the moment which is frustrating for employers and employees alike. 

What should care homes do to prepare?
Amidst continuing guidance from the Government and some unwelcome changes, there are key preparatory steps that should be taken by care home providers. These are all the more key given that the last date for workers to receive their first vaccine was 16 September. These key preparations can be found in this blog. This blog was written on 14 July prior to the guidance being published but the details and advice remain the same.

Has there been any opposition to such draconian measures?
Given the potential breach of human rights in making vaccinations mandatory, it is not surprising that the Regulations have already been challenged. We are awaiting formal proceedings on the grounds that, amongst other things, the Regulations are disproportionate on human rights grounds, there has been insufficient inquiry and the Regulations themselves are irrational. It is hard to say whether such a challenge will be successful. Until we know one way or the other, we would advise all care home providers to prepare for 11 November assuming the Regulations will remain in force. We will of course keep you updated on the progress of the judicial review of the Regulations.

We are also aware that providers are receiving letters from staff challenging the Regulations. Our advice to clients remains that these Regulations have been imposed on you by the Government and therefore you have no option but to comply with them. We have assisted a number of providers with responding to staff challenges on this basis.

Are there any other laws like this coming down the track?
The Government is consulting on extending mandatory vaccinations across all health and care settings. The consultation period ends 22 October 2021 and we would advise all providers of CQC regulated care homes to respond. A summary of the issues can be found in this blog.

For more information

If you would like more information about the Regulations and their implementation contact Matthew Wort or Anna Dabek. Please do enquire about our toolkit which provides both critical advice and draft documentation to help providers through the process of implementing the Regulations.

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