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Following our overview of the COVID-19 Vaccination Programme 2020/21 last week, NHS England (NHSE) has provided an update on the programme to dispel some of the myths and concerns so that general practice feels safe and confident to deliver it.
NHSE wants this to be and feel achievable and understands the anxiety about delivering this programme because it is completely different to anything that has been done this way previously.
Here are a few Mythbusters:
1) Why is the contract an Enhanced Service (ES) and not a DES?
There are statutory regulations in place for Direct Enhanced Services (DES), which means they are more difficult to change. Everyone is responding quickly as we learn more about the product characteristics of the vaccines so the contract will require contractual adjusting when required. However, the enhanced service has been structured for Practices to work together at scale to arrange the delivery of vaccines more easily to the relevant target groups. The enhanced service refers to PCNs, but other Practice groupings could be deployed if appropriate.
2) When will we receive the final contract?
Practices are only currently signing up (by 17 November) to express an interest in being a designated site. When NHSE has collated the site information details, the service specification will be issued (probably week commencing 23 November) with more of the detail about the vaccine characteristics and the vaccine programme.
3) Why one site per PCN?
This is due to the manufacturing process and supply, the cold chain and shelf life, which means that the vaccine cannot be delivered like the flu vaccine. If things change in the future it may be possible to have more delivery sites based on geography to work for both rural and urban communities.
4) What do we know about the vaccines?
There will be 2 candidate vaccines currently called by their trade names Courageous (produced by Pfizer) and Talent (produced by Astra Zeneca). They have not been licensed yet, but this is expected in the next couple of weeks. They have very different approaches to delivery, including storage temperature, multi-dose and dilution. There is no long-term data about immunity, it will be subject to ongoing monitoring and surveillance.
5) How will we receive the vaccines?
The first vaccine (Courageous) will be delivered to designated PCN sites or NHS Hubs then thawed out and diluted. There are 5 doses per vial (70 doses per box), given twice to each Patient at an interval of 21 days between doses and the vaccines must be used within 5 days. Talent does not need diluting but will need drawing up. When the licensing arrangements are agreed, more information will become available and most of this is currently beyond NHSE control. It is expected that there will be a national process for ordering COVID-19 vaccines.
6) Who will receive the vaccination?
Currently, the Joint Committee on Vaccination and Immunisaiton (JCVI) have prioritised the cohort for vaccination as older residents in care homes and care home workers, followed by those aged 80 and over and health and social care workers. Following on from this, the prioritised will be in age groups and risk factors from older people to younger people as the vaccine becomes more widely available. Consideration will be given to care home staff to have the vaccine at the PCN site, even if they are not registered with a Practice within that PCN, so that a slightly broader population would receive the vaccine locally.
7) How will Patients receive the vaccine?
The current arrangements will be for vaccines to be administered at the site they are delivered. The DHE has confirmed that anyone who is driving immediately after having the vaccine should wait for 15 minutes before driving, to ensure they do not have any adverse effects and are safe to drive. Everyone else can leave the vaccination site straight after they have received their vaccine, as they do after having other vaccinations.
8) What about consent?
The consent will be expressed consent, and consideration will be given about consent for those who may not have capacity such as some residents in care homes or those who lack capacity. It will be important to involve relatives and those who have lasting power of attorney, then agree consent based on the best interest of the Patient, as it is for other vaccines. National consent forms and other wider materials will be made available for Practices such as pre and post-vaccination information and in different languages, so Practices will not need to print these off themselves.
9) Are we expected to be open 8am – 8pm 7 days a week?
The contract is written in such a way so that PCNs could deliver the vaccine on a 7-day a week basis, but it does not mean they will be required to deliver vaccinations every single day. NHSE must be confident that vaccines can be given before they expire (e.g. on a Saturday or Sunday) so that vaccines are used up to avoid wastage – every vaccine received should be given to somebody. PCNs could call on a bank of staff who can come in to vaccinate people to use those vaccines up that are due to expire at the weekend.
10) Will we have to open at Christmas?
NHSE have made it clear that they want to staff to rest over the festive period, especially considering the extremely challenging year everyone has had, so staff will not be expected to work on the Christmas Bank Holidays. However, because we do not yet know delivery dates, there is a very small chance that a large batch of vaccines could arrive a few days before Christmas and consideration must be given about how they are delivered to Patients in a timely way. There may need to be some arrangement to deliver these vaccinations using a pool of reserve staff who have volunteered to work on the Christmas Bank Holidays.
11) What about other work such as QOF?
There will be agreement with CCGs to help Practices prioritise their core work and local organisations will help to prioritise and deprioritise other work so that the COVID vaccine programme is delivered. Local enhanced services should (where possible) be repurposed to make funded capacity available for COVID-19 vaccinations. QOF has been significantly income protected around long-term condition management activity and these must still be clinically prioritised but will not impact payment. The QI modules in QOF have also been significantly revised to support essential activity.
12) Who else will be involved in delivering the vaccines?
General practice will play a key role in the vaccination programme, since NHSE believes they are the right providers to access Patients at risk and in care homes, who are not always easy to target. However, other providers will be involved such as St Johns Ambulance and possibly clinical pharmacists at some point. Additional workforce, including volunteers, is still being planned with discussions taking place so that this can happen. NHSE understands that staffing may be difficult, so it wants to make funding flexible to support Practices.
13) Will staff be indemnified?
This vaccine programme is being delivered under the NHS by Practices and their staff, so all workers will be covered for indemnity and liability within the scope of the clinical negligence scheme for GPs (CNSGP). There will be arrangements in certain areas where volunteers are helping with the programme, so NHS Resolution will also view volunteers who are working on behalf of Practices and PCNs in the same light for indemnity.
14) What about funding?
£150m of re-prioritised capacity funding has been ring-fenced to support general practice to deliver those programmes and NHSE has made it very clear that this money must not be used for other services but must be used to support general practice only. CCGs should not produce overly burdensome systems for how Practices access the money.
15) How will we continue to meet CQC registration during this programme?
The CQC has published an update on its website about registration and COVID-19 vaccination arrangements, as it did previously for flu vaccinations which were administered off-site.
16) Will staff need training?
Centrally available training will be provided online for free by NHSE, and different types of training will be required for different cohorts of staff, e.g. clinical staff, such as Nurses and GPs who already administer flu vaccines. Some non-clinical staff will also be able to undertake training which will be much more comprehensive than for clinical staff. They would not be the ones making clinical decisions or taking consent, they would purely be trained to physically administer the vaccine to the Patient.