Appendix 1: Draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021
Additional information from the Department of Health and Social Care
Q1: Statistics: In relation to the data in https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/06/Older-Adult-Care-Homes-Vaccinating-80-of-staff-and-90-of-residents-June-2021.xlsx
Can you please explain the difference in the statistics between the second table which shows 70.2% of all staff have had both vaccinations and the penultimate table which shows care homes reporting puts the figure a lot lower at 48.1%?
A: In the published data above the % of eligible staff of older adult care homes vaccinated with 2nd dose is 70.2% - this is the % of people in the ASC workforce who have had the second vaccination. The lower 48.1% figure referred to the proportion of Older Adult Care Homes with at least 80% of total staff vaccinated with a 2nd dose. This is to capture the % of care homes where at least 4 in 5 staff have had the second vaccination.
Q: Can you please explain the difference in the statistics between the first table which shows 91.3% of all residents have had both vaccinations and the final table which shows care homes reporting shows only 74% of homes meet the 90% threshold?
A: As above; here the 91.3 % refers to the % of residents overall who have had both vaccinations in the linked publication. The 74% is the percentage of care homes where at least 9 in 10 residents have had the second vaccination.
Q: What are the equivalent figures for care homes for residents under 65?
A: These are published here Statistics » COVID-19 Vaccinations (england.nhs.uk)
Q: What proportion of all care homes cater to the over 65 age group?
A: There are around 15,000 care homes of which around 10,500 cater (but not exclusively) for older adults.
Q: Why does DHSC think vaccine uptake is low among care workers?
A: Thanks to the incredible efforts of people across the sector, over 1.2 million social care workers in England have now been vaccinated. This is a fantastic achievement, and an important step for staff to protect themselves, their loved ones, and the people they care for, from becoming seriously ill or dying from COVID-19.
Vaccine uptake nationally in the care home workforce is high, at 85.6% for first doses and this is in line with vaccine uptake in the general population (as of 01/07/21 from https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/07/COVID-19-weekly-announced-vaccinations-01-July-2021.xlsx). There is, however, significant variation at a regional, local and individual care home level.
The SAGE Social Care Working Group have advised that at least 80% of staff and 90% of residents in a care home should have had a first vaccination dose to provide a minimum level of protection against outbreaks of COVID-19, recognising that current or emergent variants may require even higher levels of coverage and/or new vaccines to sustain levels of protection. The dual 80% or 90% threshold provides only a minimum level of protection; higher coverage and both doses would increase that level of protection. While the majority of care home workers have been vaccinated, the latest published data (as of 13/06/21) highlighted that only 65% of older adult care homes in England were meeting the SAGE level of 80% uptake of first doses among staff needed to reduce the risk of outbreaks in these high-risk care settings - falling to 44% of care homes in London. Sustaining high levels of staff vaccination now and in the future as people enter the workforce is important to minimise the risk of outbreaks.
Q: Is any of it attributable to simple demographics - for example, are a large proportion of these workers under 30 and have not therefore been eligible for a second dose?
A: All care staff in older adult care homes were prioritised for the vaccine in JCVI Cohort 1, regardless of their age. Demographically, the ASC workforce is not significantly younger than the national working population, however this workforce is significantly more diverse, with 21% of ASC workers from BAME backgrounds, compared to 14% of the general population. Data suggests that uptake amongst people from ethnic minority backgrounds is lower than for other groups, so this may be a contributing factor to the vaccine uptake rates in the ASC workforce.
We recognise the importance of raising awareness of the benefits of vaccination within Black, Asian and minority ethnic (BAME) communities who are known to be more at risk from COVID-19. We have met with faith leaders and the Moral and Ethical Advisory Group (MEAG), on COVID-19 immunisation and sought consideration of how best to clearly communicate about the benefits of the vaccine.
We have been working to make the vaccination accessible to people living and working in care homes–we have visited every eligible care home in England, offered vaccines to all staff, and continue to work closely with the care sector, independent healthcare providers and local leaders, to maximise vaccination numbers and save thousands of lives.
NHS England is running a minimum four-visit schedule for each older adult care home. For those workers who may not have been present when the vaccination team visited the home, access via other vaccination services have been available.
Q2: Consultation: the analysis provided in the EM only focuses on the positives, yet 57% of respondents objected to the proposal. Please give DHSC’s view of the key objections and how it plans to address them.
A: The government response to the consultation answers the key concerns in detail and sets out a range of mitigations. These are summarised below and the full response can be found here: Making vaccination a condition of deployment in care homes: government response - GOV.UK (www.gov.uk)
The key issues raised are noted below alongside our proposals in light of concerns:
Exemptions:
Noting the concerns raised about rare blood clots as a side effect of vaccinations, we will ensure people under the age of 40 will be offered an alternative to the Oxford/AstraZeneca vaccine, in line with the Green Book on Immunisation against infectious diseases (COVID-19: the green book, chapter 14a) and clinical advice from JCVI.
We have considered the concerns raised about pregnancy. We have been assured by clinicians that vaccines are safe for the majority of pregnant women, however we recognise that in some circumstances, vaccination may not be appropriate during pregnancy and we will consider that in our guidance regarding granting exemptions.
Implementation:
In response to concerns that not all people covered by the policy have access to a smart phone, we can provide reassurance that we intend to provide a web-based solution for people who do not have access to the app, as well as a non-digital solution, in the form of a letter.
While, overall, respondents were split on whether the policy would be easy or difficult for managers to implement, we take on board feedback that small care homes will find the policy much more challenging to implement. We are exploring steps to mitigate this risk, including working with Skills for Care to ensure that local authorities and providers will have access to guidance and resources to support workforce capacity and resilience, in light of this policy.
We have taken on board the need for a suitable grace period for implementation of the policy and have amended the legislation accordingly to include a 16-week grace period from when the regulations come into force. We have recognised the calls for an Impact Assessment and intend to publish this as soon as possible.
Impact and implications
We recognise that there are concerns about the potential impact of the policy on maintaining safe staffing levels if staff decide to leave as a result of the policy, and the concerns of Local Authorities and NHS partners about the impact of the requirement on their ability to commission services. We want to emphasise that the majority of those who work in care homes have already taken up the vaccine and we will continue to encourage people working in care homes to take up the offer going forward. To mitigate the risk of an immediate effect on capacity, we have included a 16-week grace period. This would enable the vast majority of workers to receive both vaccination doses and should therefore minimise the risk of sudden departures from the workforce. We are looking to deliver another National Recruitment Campaign in order to attract people into the sector and promote adult social care careers. We are working with Skills for Care to ensure that resources such as guidance and best-practice are available to support providers and local authorities with capacity and workforce planning, recruitment and well-being. Skills for Care will also provide local and national workforce support to local authorities and employers. We will also work with local authorities to ensure they are contingency planning and accessing additional support, as well as promoting joint working across a region to assist with targeted recruitment. DHSC continues to liaise with local authorities and stakeholders to continue to learn about the guidance needed to smooth the process for implementation.
A number of respondents have raised concerns that younger adults with a learning disability and autistic people who live in care homes would be disproportionately affected if they were not included in the policy. We have taken this feedback on board and have extended the requirement to all CQC registered care homes in England where the service provider provides accommodation for persons who require nursing or personal care (see change 1).
We are addressing concerns about access to vaccination and will continue to promote access for care workers and other people who are within scope of the policy to make it as easy as possible to take up the offer of vaccination. We will also continue to ensure that vaccine guidance and information is readily available in a variety of formats such as easy-read, large print and Braille, as well as being accessible via screen readers and in different languages.
We recognise concerns that certain groups within the workforce may be more vaccine-hesitant and therefore could be negatively impacted by the policy. We are also providing tailored support to key groups in the workforce. This is designed to build confidence among:
- women of childbearing age. We are working with clinical experts to address their questions and concerns about the vaccine, including concerns around pregnancy and fertility, for example these issues were addressed during a webinar for social care workers on 21 May 2021, hosted by Minister Zahawi
- people from Black, Asian and Minority Ethnic groups who may be hesitant about taking the vaccine. We are delivering tailored communications and working in partnership with trusted community leaders
- people with concerns about the vaccine, based on religion or belief, including, for example, by sharing information to tackle common concerns about vaccine ingredients or the safety of vaccines
We have published a Public Sector Equality Duty (PSED) Assessment alongside this response and will carefully track the impact of the policy on vaccine uptake, once it has been implemented.
To address the concerns raised by care providers regarding potential inadvertent breaches of data protection law, we have inserted a provision in the regulations so that a service provider may process information provided by a person wanting to prove their vaccination status, in accordance with the Data Protection Act 2018.
Based on feedback received during the consultation, we have made three key changes to the proposals set out in the original consultation document:
1.We are extending the scope of the policy to all CQC-registered care homes, in England, which provide accommodation for persons who require nursing or personal care, not just those care homes which have at least one person over the age of 65 living in their home
2.We are extending the requirement to be vaccinated to include all persons who enter a care home, regardless of their role (excluding those that have medical exemptions; residents of that care home; friends or relatives of residents who are visiting; those entering to assist with an emergency or carrying out urgent maintenance work ; those who are visiting a resident who is dying; those where it is reasonably necessary to visit to provide comfort or support to a resident following the death of a friend or relative, and those under the age of 18). The requirement will apply to any professionals visiting a care home, such as healthcare workers, tradespeople, hairdressers and beauticians, and CQC inspectors. The requirement will not apply to people who only work in the outdoor surrounding grounds of care home premises.
3.The initial proposals set out that individuals will be clinically exempt from the requirement if they have an allergy or condition that the Green Book lists (COVID-19: the green book, chapter 14a) as a reason not to administer a vaccine. We will also provide exemptions for clinical trial participants. We intend to publish further guidance to describe, in more detail, the scope and process for granting exemptions, which will continue to be informed by the Green Book.
Q3: What constitutes proof?
What evidence of vaccination will be acceptable?
How is the registered person supposed to demonstrate compliance - will they have to photocopy the person B’s NHS record/app?
What evidence of exemption will be acceptable? Will the registered person have to photocopy medical evidence to prove the individual is allergic/asthmatic/pregnant?
A: The intention is that an individual’s vaccination status could be provided to the NHS App, this will then be used to demonstrate evidence of vaccination. There will also be a paper-based method available which will ensure the policy is inclusive and enable all non-exempt individuals to show evidence of their vaccination. Care homes will be required to keep their own local records of compliance. This will be in the form of evidence of vaccination or exemption from vaccination for staff which they deploy. Due to the wide variety of settings the method of proving compliance will be a localised decision based on what is appropriate for each setting and not prescribed by DHSC.
To demonstrate proof of exemption from vaccination, if a clinician has determined that an individual should be exempt from vaccination (criteria for exemption will be fully outlined in our guidance), this would be displayed via the NHS app or a paper-based solution. These solutions will take into account data protection requirements for the individual.
The details of these digital and paper-based solutions will be outlined in the operational guidance which we are currently consulting with stakeholders on and will be published at the earliest opportunity.
Q4: What is the scope of the legislation?
What is the scope of “registered person” - is it the home manager or any care worker or nurse who happens to be on duty at the time person B tries to enter?
A: The 2014 Regulations provide that a ‘registered person’ means, in respect of a regulated activity, a person who is the service provider or registered manager in respect of that activity. The service provider is the legal entity responsible for carrying on the regulated activity. A registered manager is the person appointed by the provider to manage the regulated activity on their behalf, where the provider is not going to be in day-to-day charge of the regulated activities themselves. As a registered person, the registered manager has legal responsibilities in relation to that position. A registered manager shares the legal responsibility for meeting the requirements of the regulations with the service provider.
As such, it would be the responsibility of the registered person to ensure that the draft Regulations are complied with, and to set clear guidelines and policies to staff so that they are aware of the obligations placed on the registered person by the draft Regulations, and to ensure that they do not permit entry to unvaccinated persons into the care home premises (subject to relevant exceptions). Care workers, nurses etc. on duty at the time person B tries to enter the premises would not, however, be held legally responsible and accountable for compliance with the draft Regulations. It is only the registered person who would be held responsible and accountable for such compliance.
In the event that the registered manager is absent for a continuous period of 28 days or more, the legislation allows for providers to plan for those absences. Regulation 14 of the Care Quality Commission (Registration) Regulations 2009 requires a registered person to notify the CQC when the manager will be absent for a continuous period of 28 days or more, to include the name, qualifications, the contact details for the person who they intend to manage the activity(ies) during their absence, and to notify the CQC when the registered person returns from a significant absence.
- The registered person “must not permit a person to enter the premises of that care home, unless that person meets one of the specific requirements listed in 7.4.” - how literal is that? Does it mean not permit them to work in the establishment or literally not let them past the front door?
In accordance with the plain, ordinary meaning of the Regulations, the registered person must not permit a person to enter the premises of the care home, unless they meet one of the specific requirements. As such, in response to your question, a person would not be able to enter past the front door of the premises, unless they meet those requirements.
Q5: Sanctions:
What are the range of potential sanctions on registered persons who fail to comply?
The EM mentions: “Where providers do not comply with the requirements set out in this instrument, CQC could consider taking regulatory action, for example through the issuing of a warning notice.” - what are the implications of a warning notice?
A: CQC can use their enforcement powers to take action, in accordance with their enforcement policy, where a provider doesn’t comply with the regulation requirements. It is important to note that CQC’s decision on whether and what enforcement action to take will depend on the specific circumstances of the individual case, including their assessment of the impact on quality of care and people’s safety, and is based on proportionality. CQC may decide it is not appropriate to take action against a single issue if mitigating rationale can be provided, depending on the seriousness of the issue.
CQC has civil enforcement powers to cancel, suspend or impose conditions on the registration of a provider (sections 17 and 18 of the Health and Social Care Act 2008). Except in the case of urgent action, this usually involves a protracted legal process before this type of action can take effect. CQC also has criminal enforcement powers in relation to unregistered providers and breaches of certain regulations.
It is likely that any enforcement action will be undertaken under Regulation 12. Regulation 12 imposes a requirement on providers to provide safe care and treatment. This includes a requirement for the provider 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 SofS IPC Code issued under s.23 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, CQC will look at whether to take criminal enforcement action (e.g. prosecution).
Any decision to take criminal enforcement action (fixed penalty notice or prosecution) must follow the Full Code Test for Crown Prosecutors: (i) there must be enough evidence to provide a “reasonable prospect of conviction” and (ii) the prosecution must be in the public interest.
CQC guidance available online sets out the implications of a warning notice: Enforcement guidance: Warning notices | Care Quality Commission (cqc.org.uk)
Q6: Guidance
“The Government intends to publish operational guidance by the end of July.” - this probably answers most of the questions above but is not available when the SI is going through scrutiny (which is regarded as poor practice). When is the text going to be available?
A: As set out in the Explanatory Memorandum, operational guidance is currently under development and we intend to publish it at the earliest opportunity.
Q7: Impact;
“A full Impact Assessment has been prepared and will be submitted” - again it is not available during scrutiny which is regarded as poor practice. When will it be available?
A: As set out in the government response to the consultation on making vaccination a condition of deployment in care homes, we have recognised the calls for an Impact Assessment and intend to publish this as soon as possible.
Q: As well as the financial costs of implementing this policy, which the EM sketches in, what analysis of the future availability of care home staff has been undertaken ie if 30% of care home staff suddenly become ineligible for employment because they choose not to take up the second vaccination who is going to provide care for the residents?
I note para 12.3 of the EM says for Local Authorities “Contingency plans should already be in place to deal with workforce shortages and provider failures as set out in the Care Act.” How feasible will these be if there is a diminished pool of qualified staff to recruit from?
A:To mitigate the risk of an immediate effect on workforce capacity we have included a 16-week grace period before the requirement takes effect. This would enable the vast majority of workers to receive both vaccination doses and should therefore minimise sudden departures from the workforce.
We are working with Skills for Care to ensure that resources such as guidance and best practice are available to support providers and local authorities with capacity and workforce planning, recruitment and well-being.
We will also work with local authorities to ensure they are contingency planning and accessing additional support, as well as promoting joint working across a region to assist with targeted recruitment.
As of Sunday 27 June, 402,231 staff in care homes serving any older people have been vaccinated with the first dose (85% of total staff). 347,236 staff are reported to have received a 2nd dose (74% of staff) based on responses from 98% of providers. We will continue to monitor data, at the level of individual local authorities, on vaccine uptake rates and workforce capacity using submissions from ASC employers to inform our work moving forward.
Q8: And just to be clear: the EM says “In response to the consultation DHSC will extend the scope of the policy to all CQC registered care homes in England providing accommodation for persons who require nursing or personal and to include all persons who enter a care home, regardless of their role”–as we understand it these Regulations include that broader scope (i.e. we are not talking about a second set of regulations at some future date). I would be grateful if you could confirm that interpretation.
A: This is correct–see Regulation 5 of the draft SI.
Q9: We read that it is the Government’s intention to bring forward a programme of booster jabs from September for the over 50s 32 - would that be included in “B has been vaccinated with the complete course of doses of an authorised vaccine”?
A: The draft regulations do not cover boosters. An amendment to the regulations, later in the year, would be needed to cover them.
5 July 2021
32 For example here: ‘Covid: NHS plans booster jab for those 50 and over before winter’, BBC News (2 July 2021): https://www.bbc.co.uk/news/health-57667987.