BMA GPCE (GP committee England) and NHSEI agreed an ES (enhanced service), directed by NHSEI, for general practice in England to lead the delivery of the CVP (COVID-19 vaccination programme).
The CVP is delivered by groups of practices, generally covering PCN (primary care network) footprints.
Second phase (cohorts 10-12)
NHSEI and GPCE agreed an extension to the existing ES specification for existing practice sites to administer vaccinations to patients between the age of 18 and 50. This is not currently covered in the ES.
NHSEI authorised the commencement of the second phase on 13 April, beginning with 45-49 year olds. Practice groupings can invite these patients for their first vaccination if they have sufficient supplies, alongside continuing with second vaccinations to those patients who are due to receive it. This follows a JCVI statement on phase 2 of the vaccination programme, which recommends continuing to prioritise people by age.
The service specification arrangements for this second phase of the programme will mirror the arrangements for the first phase. Sites will still get the £12.58 item of service fee for each vaccine administered.
Importantly, we agreed that the funding for PCN clinical directors we previously secured will continue for the first quarter of 2021. As before, this can be used to support other key members leading on the vaccination programme within a practice group.
There are three main criteria that practices needed to show they could fulfil before being approved to deliver this second phase:
- assurance that they are also able to fulfil their other contractual requirements of delivering clinical care to patients
- that practices will be using additional workforce capacity (above routine care providing and the initial phase of the vaccination programme)
- show that all eligible patients in cohorts 1-9 have been invited for their first dose, and made significant progress to vaccinating them, and that they can deliver second doses for all those patients that have already received their first dose.
Practices should have carefully considered these criteria when deciding whether they are prepared to undertake the second phase. More detailed information on these criteria and on the process is available in the joint letter and guidance.
This small number of serious adverse events needs to be seen in the context of over 4m COVID-19 infections since the start of the pandemic causing more than 120,000 deaths.
JCVI are now recommending that 18-29 year olds who do not have underlying health conditions putting them at increased risk of COVID-19 should be offered an alternative to the AstraZeneca vaccine where available.
MHRA and JCVI confirmed that the risk/benefit of getting the vaccine is favourable for the vast majority of people, but more 'finely balanced' in younger people.
Practices that did wish to vaccinate cohorts 10-12 should have advised their local commissioner how many vaccinations they could do each week to ensure local capacity is in place. There will continue to be a choice of provider for the local populations and no expectation that practices or a PCN grouping has to vaccinate its entire cohort.
Can individual practices opt out?
For the purposes of the ES, it's all or nothing in terms of the practices within the PCN taking on cohorts 10-12. Either they all opt-out or they are all opted-in.
However, how the practices within the PCN decide to deliver the programme is up to them. So a practice that doesn’t wish to take part should still remain opted-in but be a silent practice where their patients are covered by the rest of the PCN.
In these circumstances the PCN will need to consider the funding distribution within the PCN to reflect this arrangement.
A PCN could also amend its collaboration agreement if individual practices wanted to increase or decrease their involvement.
The PCN grouping can choose to opt-out of the cohorts 10-12, but still deliver the programme to cohorts 1-9 (first and second doses) as currently.
What the service involves
Everyone over the age of 18 is eligible for COVID vaccination, in a prioritised order as decided by JCVI (joint committee on vaccination and immunisation) and outlined in their recommendations.
The ES includes provision of vaccinations to housebound patients via home visits, as well as staff and residents of care homes. Community service providers play a role in this service, particularly with housebound patients, as many do with flu immunisations using practice stocks.
It also allows PCNs to vaccinate the patients of non-participating practices and to unregistered patients.
Practices will need support from CCGs and ICSs, as well as local authorities, to relieve other pressures and assist with the programme. However, the documentation is clear that this is general practice led – CCGs and ICSs cannot dictate how it should operate.
NHSEI has been clear that CCGs should not micromanage the operational elements of the CVP as this service is practice-led.
How the service operates
The current model for delivery is through groups of practices working together (along PCN footprints), with one designated vaccination site.
NHS England published a SOP (standard operating procedure) for vaccination deployment in community settings, including general practice.
Practices must have a collaboration agreement in place to agree the roles and responsibilities of each practice and how the programme will be delivered. NHS England has published a collaborative agreement that practices can adapt further if they wanted to, but this should not be necessary.
Call and recall system
Patients can choose to attend either their local general practice-led designated site, or a regional immunisation service. If patients choose the local site, practices will need to contact patients to book an appropriate time. Practices can use the national booking system instead of their local booking system if they choose.
Administering the vaccine
A registered healthcare professional will carry out the clinical assessment and consent. A suitably trained non-registered member of staff will administer the vaccine itself under clinical supervision.
- Pfizer vaccine patient group direction
- Pfizer vaccine national protocol
- AstraZeneca vaccine patient group direction
- AstraZeneca vaccine national protocol
Vaccine recipients need to be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment. For more information, see the MHRA urgent precautionary advice for healthcare professionals.
A SOP (standard operation procedure) for the management of COVID-19 vaccination clinical incidents and enquiries has also been published.
We have created additional guidance on how you can utilise extra workforce to deliver the vaccination programme.
It is for practices to determine how they work together to deliver the programme. For instance, practices could operate a rota using their teams to immunise their own registered patients in different sessions during the week. Or, they may wish to employ a dedicated team to do this on behalf of all practices, or for some practices to act on behalf of others.
Administering the second dose
Patients will need to be contacted again to book in their second appointment (or this could be done at the time of administering the first) allowing for the appropriate gap.
Patients will need to receive the second dose from the same practice grouping. In some cases, patients receiving a second AZ (AstraZeneca) dose may do so at their own practice (as opposed to the original designated site), but only where their practice is part of their original practice grouping that delivered the first dose.
NHSEI has published FAQs on the administration of the second dose.
Practices are able to transport the AZ vaccine from the designated site, to their own practices, or care homes or patients’ homes, to administer at those sites.
Deliveries of the vaccine will still be made to the designated site, and practices will be responsible for any onward transport.
Pfizer vaccines must be administered from the designated site. There is a lack of flexibility associated with this vaccine due to the logistics of transport and storage.
Practice groups must prioritise the delivery of vaccines to eligible patients, and should plan accordingly. In some instances, surplus vaccine supply may happen – for example, where fewer patients attend vaccination clinics than was expected.
In these instances, the overriding principle will be to avoid wastage, so NHSEI has advised that the residual vaccines may be administered to vaccinate other eligible patients.
Sites should have reserve lists that they can use to make every effort to invite patients or healthcare professionals to make full use of any unused vaccines rather than have any go to waste. If necessary, remaining doses can be given outside the current cohorts if there is no one else available.
If a practice group is no longer able to deliver the ES it should notify the CCG at the first possible opportunity, which will work with NHSEI to identify logistical support available to enable the group to deliver the ES.
In instances where the group is still unable to deliver the ES, NHSEI will redirect the delivery of vaccine supplies to avoid wastage.
Funding and resources
- Practices will be provided with the vaccines, needles, syringes, diluents, fridges and PPE.
- Practices will also be provided with 4G-capable IT equipment as well as any barcode scanner that may be required.
- Public Health England has published consent forms and letters for use by practices, as well as a range of patient leaflets.
- A £12.58 IOS (item of service) fee will be provided per dose.
- A PCN grouping can claim an additional supplement of £10. This is for each vaccination administered to residents and staff in settings such as care homes for people with learning disabilities, or hostels for homeless people, where it would not be possible to attend vaccination sites.
- A £10 supplement per visit to support the vaccination of all housebound patients, applying retrospectively from 14 December 2020. This will apply to first doses and second doses separately.
- Additional funding for PCN clinical directors we previously secured will continued for the first quarter of 2021.
- PCNs which brought in additional workforce until the end of January to ensure that all records for vaccination of priority cohorts were up to date and recorded properly are eligible to claim up to £950 per week (a maximum of £2500 per PCN grouping) of funding support.
- Additional local funding will be provided, in line with the additional funding for the flu programme arrangements (for example for hire of venues, additional storage, coverings for outdoor waiting areas, text message credits etc). This will need to be agreed locally.
- Local enhanced services re-purposed by agreement with CCGs to make funded capacity available for the CVP.
- £150m of further support was available from NHSEI for additional capacity, ringfenced for general practice until the end of March 2021. BMA GPC has secured an additional £120m for general practices from April 2021. It will be weighted towards those practices involved in the vaccination programme, but some will be available for others. Monthly allocations will be £30m in April and May, £20m in each of June and July, and then £10m in August and September.
- Extended access and hours capacity reprioritised to provide additional capacity.
- Parity of funding with other providers of the programme - depending on the services given eg serving housebound patients is logistically more difficult than mobile patients. We will be ensuring NHSEI lives up to this commitment.
- Practices are paid for the vaccines administered; if they withdraw from the programme they will receive payment for doses administered up to the point of withdrawal. They would need to ensure that any patient who had already received their first dose was provided with the second, before withdrawing the service.
When combining new funding for additional capacity, the vaccination item of service fee, utilising extra workforce including locums and prioritising work - practices and community teams can work together to successfully deliver the service.
NHSEI also has a national pool of workers that can be deployed into practice sites to provide additional capacity.
QOF income protection for 20/21 will enable practices to prioritise COVID-19 vaccination activity, alongside those who would most benefit from review of their long-term condition
Changes to existing funding and workload
NHS England has been clear that practices can offer an urgent-only service while vaccinating practice teams are involved in the programme.
Other work and services can be deprioritised. GPCE and RCGP have revised our joint workload prioritisation guidance to assist practices in this.
NHSEI has instructed CCGs to:
- take a supportive approach to minimise local contract enforcement across routine care
- suspend any locally commissioned services except where these are in support of vaccination or COVID-related
- consider whether clinical staff involved in CCG management could be made available to support practices.
The BMA has also secured NHSEI agreement that appraisals can be declined during this period. Other admin-reducing measures implemented earlier in the year remain in place.
- QOF (quality and outcomes framework) income protection is in place - in addition to the existing protections for 310 QOF points, there are eight prescribing indicators (to be paid on the basis of historical performance), as well as full income protection for all 74 points in QI modules, to apply from January to March 2021.
- Minor surgery DES (directed enhanced service) income will be income protected until March 2021.
- The management of long term conditions should be managed by clinical prioritisation with continued patient contact, but this will not impact payment.
- ARRS (additional roles reimbursement scheme) staff can be deployed to vaccination as integral members of PCN teams. ARRS recruitment should continue with full funding remaining in place.
- The number of SMRs (structured medication reviews) to be delivered will be limited by PCN clinical pharmacist capacity. It's likely that the CVP is considered a priority for deploying available clinical pharmacists in the short term.
- A PCN may use its additional roles reimbursement sum to reimburse extra hours worked by PCN staff, at plain time rates only, as long as the increase in whole time equivalent hours worked is clearly recorded on the PCN’s claim form and national workforce reporting system.
- CQC are easing burden on providers in this period.
- The funding and staff providing the improving access schemes can be used to deliver the service with local agreement, particularly in the evenings and at weekends. LMCs should discuss this with the local service providers to allow good collaboration.
GPCE will closely monitor the situation and work with NHSEI to ease further workload pressures where possible. With the prioritisation process in place, NHSEI and commissioners will be assured that practices are continuing to deliver what patients need.
Staff may be moved from their regular commitments to provide the vaccines (remembering there will be staff from multiple practices). This will provide the staffing, without additional cost.
Most of the vaccine programme will be delivered by nurses, health care assistants and supported by PCN and practice pharmacists, assisted by practice staff, rather than GPs.
Practices will therefore need to reduce other nurse-led services. Practices will share with other practices in vaccination delivery in the designated centre, this may be on a rota basis, so could be one day a week, not seven days a week for a typical practice.
Any additional capacity required can be covered under the funding, through increasing hours of existing staff and/or engaging locums. Extended access services can also be used for vaccination delivery on evenings and weekends.
Practices can also access clinical and non-clinical staff and volunteers from the national workforce supply routes.
Read more in our utilising extra workforce guidance.
Practices can use other providers (eg pharmacy and community providers) to assist with the programme, with their agreement.
They should use existing agreements for flu immunisation delivery (as is the case for many PCNs) or put in place similar arrangements if not already done. Practices will need to factor this into their considerations for workforce planning and funding distribution.
Arrangements for home visits currently in place in many areas for flu vaccines, with providers working together to ensure coverage (for example community providers and district nurses) will be expected to be maintained, and if not in place to be put in place. NHSEI strongly encourages CCGs to work with community providers to assist general practice to deliver the service. We encourage LMCs to discuss this with their CCG and local community provider.
The threshold for annual allowance in the pension scheme has been increased from 2020 onward.
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The vaccines and their characteristics
There are two vaccines currently being supplied to general practice, Pfizer and AstraZeneca. The Moderna vaccine is now also licenced for use but is not currently expected to be supplied to general practice. As these and other vaccines are developed and tested their characteristics might change.
|The Pfizer vaccine||The AstraZeneca vaccine|
Safety and risk
The vaccines go through testing procedures and MHRA's (medicines and healthcare products regulatory agency) licencing process. Confirmation of the specific vaccines is given following completion of trials and licencing/approval. The JCVI and others will provide independent input and decisions are made in the normal way.
The Government previously released the outcome of the human medicines regulations consultation. This outlines that the Government will be liable for any adverse implications from a vaccine being put into supply (both immediately and into the future).
Commissioning as an enhanced service ensures that all individuals delivering the services will have indemnity under the clinical negligence scheme for general practice.
Practical considerations for setting up the programme
Firstly, think about who your target population is (based on JCVI recommendations).
How many of those you’re likely to receive to the vaccination site.
How many will require a visit.
This will set the expectation of what you need to deliver.
Which one practice (or another appropriate site) is used for the vaccination site? Remember that provision potentially needs to be available 8am - 8pm, seven days a week to all patients of the participating practices and considering storage facilities.
What are the implications for services at practices where their staff may be deployed instead to the designated vaccination site?
What happens at the designated site if it is a GP practice (for example is it just providing the CVP, or is it also providing other routine GP services too)?
Vaccinators, diluters, ushers/admin, overseeing clinician. Who is going to staff the vaccination site, who is going to do visits?
Most of the programme should be delivered by staff other than GPs, who will be most useful in overseeing and in providing routine care to other patients as needed.
Running multiple vaccination lines under the supervision of one nurse will dramatically reduce the unit cost. These economies of scale have a large impact - hence the need for practices to cooperate.
Who can you redeploy to staff the vaccination site (practice staff and PCN staff)? If this is within their usual working hours then there will be no additional cost, and NHSEI has stated that you can prioritise the vaccination programme.
Remember too that you can use the staff who provide extended hours and extended access appointments (for example at evenings and weekends) so there should be no additional cost for these either.
You can also use other community providers (pharmacy, nursing etc) with their agreement, to deliver the service together remembering there may be costs involved with this.
If you do need more people, then you can use volunteers and the £150m fund to create additional capacity (either to provide the CVP or to continue routine services while existing staff provide the CVP).
- Housebound and care home patients will not be able to attend the vaccination site, so you’ll need to work out how to provide their vaccinations. It may be a practice nurse or other practice or PCN healthcare worker (during their normal working hours) or you might use the district nursing team.
- How many patients can staff vaccinate a day, and what does this mean in terms of your total numbers?
- It is worth being cautious at this stage as the first vaccine might not be practical to deliver in this way given its characteristics.
- People who do not normally work evenings and weekends (could come from the £150m fund).
- Additional staff to support existing staff (will come from the £150m fund).
- Additional travel costs (using the IOS fee).
- Additional venue hire (from local CCG funding).
- Contingency costs (using the IOS fee).
Once you’ve worked all of this through you should be in a good position to start thinking about the specifics:
- how to coordinate the appointment bookings for all patients (will all bookings be made through the designated vaccination site, or separately via individual practices, whether to use the national booking system)
- what information to provide to patients about the service, including venue timings, patient eligibility
- any approvals required for, and costs of, additional opening of the designated site premises
- how additional staff or additional hours will be paid, and how funding will flow to ensure fair distribution depending on staffing and delivery decisions
- setting up your vaccination site (patient flows, signage etc)
- how to ensure your own staff are vaccinated.