Contents

• Annex A: Further information for PCN groupings with designated sites
• Annex B

Official

Publishing approval number: 001559 / C0917

To: All practices

Cc: Clinical Commissioning Groups

1 December 2020

Dear colleagues,

Thank you for your engagement and support with the COVID-19 vaccination programme. A large number of PCN vaccination sites have now been designated and we are incredibly grateful for general practices’ commitment to ensuring their patients are vaccinated as soon as possible when vaccines become available.

We have now published the Enhanced Service Specification for the COVID-19 Vaccination Programme. This Specification has been agreed with the BMA and is available at https://www.england.nhs.uk/coronavirus/covid-19-vaccination-programme/primary-care-guidance/ and the GP contract pages https://www.england.nhs.uk/gp/investment/gp-contract/

This letter should be read alongside the published Enhanced Service Specification. Practices have until 23:59 on Monday 7 December 2020 to opt into the Enhanced Service by notifying their CCG by email.

We will shortly publish an Indicative Collaboration Agreement, which the ES requires to be in place as well as an updated Reference Guide. Both of these documents will be available here https://www.england.nhs.uk/coronavirus/covid-19-vaccination-programme/primary-care-guidance/

We expect PCN designated sites to be able to deliver at least around 1000 vaccinations per week. Many of you have asked about the possibility of additional sites becoming part of the programme, including individual practice locations. This may be possible over time as vaccine supply increases and as different vaccinations become available but at its outset, the programme will only operate from the designated sites, reflecting various logistical constraints around some of the vaccines themselves, and the wider supply chain. We will keep this position under review to balance logistical factors and access considerations, communicating any changes as quickly as possible.

Annex A provides more information about the next steps for PCN groupings with a Designated Site and the support available to them. We will aim to give sites 7 to 10 days notice of the first vaccines becoming available to ensure sites can be stood-up and clinics arranged. As you will understand, this is dependent on processes to authorise and supply the vaccine products.

We have also been asked about the hours of operation at PCN designated sites as well as the expectations around vaccinating on Christmas Day. The ES describes a need to operate 8-8, 7 days per week if required. This will only be required where the supply of vaccine necessitates this to ensure all of the vaccine available is being used to vaccinate patients as quickly as possible; this is not about creating an expectation that teams will be available when vaccine supply does not facilitate these hours, or where volumes supplied do not necessitate them.

Finally, please ensure you have signed up to receive the NHSE/I Primary Care Bulletin here to receive further updates on key programme developments. All of the key documents for practices delivering the Enhanced Service will be published on https://www.england.nhs.uk/coronavirus/covid-19-vaccination-programme/primary-care-guidance/

Ed and Nikki

Dr Nikita Kanani | Medical Director for Primary Care | NHS England and NHS Improvement

Ed Waller | Director of Primary Care | NHS England and NHS Improvement

Annex A: Further information for PCN groupings with designated sites

This annex sets out the next steps for PCN groupings with a Designated Site and the support available. It builds upon the letter we published on Tuesday 24 November on the outcome of the general practice site designation process.

A. Estates

Funding for venue hire

Wherever possible, PCN groupings have been encouraged to use existing estates or premises from which to deliver vaccination clinics. Where not possible, PCN groupings are encouraged to utilise NHS vacant space, which should be free of charge, brokered via your CCG. As a last resort, PCN groupings could hire a community / commercial venue.

CCGs will agree with PCN groupings the one-off costs of setup which will be met by the NHS from an agreed mobilisation date, applying a value for money test. Up to £20m has initially been made available to systems to meet these one-off setup expenses.

CCGs and PCN groupings should take the following into consideration when approving non-NHS sites:

• Rental cost per square metre should be reasonable for the location, comparable across the region, and agreed by the regional estates team. Professional advice may need to be sought;
• The size of the facility is suitable (and not excessive) for the intended volumes of activity;
• The landlord is not connected to the practices or PCN delivering the vaccination clinics;
• Licence period is up until 31 March 2021 – but extendable if needed for a longer period, and also terminable if needed;
• Venues should be avoided that require modifications or improvements;
• Avoidance of dilapidation or exit costs at the end of the lease, minimised through a Condition Survey ahead of occupation – this may be in the simplest form of photographs to record the condition of the premises. This will seek to reduce any liabilities and/or disputes with the landlord in respect of reinstatement and making good upon exit

If PCN groupings need to incur venue costs immediately, you are advised to contact your CCG who will be able to support you with the necessary arrangements. It is expected that occupancy of any new estate will be formally documented and PCNs will be required to present final draft Licence terms to the CCG before making a formal commitment. We will provide regions and CCGs with a sample ‘Licence to Occupy’ agreement and further advice on non-NHS sites soon.

By agreement, reasonable costs of assuring appropriate internet connectivity may be covered in the one-off setup costs.

CCGs and Practices should make arrangements to extend local clinical waste contracts accordingly to ensure waste can be removed from designated sites in a timely fashion.

CQC registration

Now that your site has been designated, you are advised to read the latest Care Quality Commission guidance to understand what, if any, changes you may need to make to your registration arrangements. The guidance can be found at: https://www.cqc.org.uk/guidance-providers/registration/registration-flu-vaccination-arrangements

B. Equipment, consumables and vaccine supply

NHSE/I has procured centrally an extensive list of equipment and consumables that will be nationally supplied to Designated Sites as standard, free of charge. This list is available on the Future NHS workspace https://future.nhs.uk/P_C_N/view?objectId=24252880

The Future NHS Covid Vaccination Programme workspace provides a community for colleagues across the country who are working to deliver the COVID-19 vaccination in primary care. If you are not already a member, please register to join the platform using an NHS or professional email address by emailing: P_C_N-manager@future.nhs.uk

Items to be supplied free of charge during set up phase

All sites:

• All sites will be automatically provided with the following equipment and consumables as part of an initial drop:
  • PPE will be supplied as part of the consumables drop to each site ahead of vaccine deliveries and PCNs do not need to source this via the DHSC portal
  • Other relevant consumables, in addition to PPE, will also be supplied.
  • All equipment required to enable set-up. A greater range of equipment will be delivered to new, non-NHS sites than to existing, NHS sites on the assumption that no relevant equipment will exist on a non-NHS site. There is no expectation on practices to transfer physical resources from any GP practices to off-site facilities where this would interrupt normal services.

Sufficient equipment and consumables will be provided to all sites (both NHS and non-NHS) to enable PCN groupings to visit and vaccinate housebound and care home patients, including laptops/tablets. Where there is a local requirement for equipment that has not been specified for central provision, PCN groupings should discuss with CCGs whether local procurement can be reimbursed as part of setup costs.

Vaccines and linked consumables

Once the vaccine supply chain is mobilised, PCN groupings will be expected to collaborate with any national, regional and STP operations centre in relation to stock forecasting and reporting.

PCN designated sites will not need to order vaccine-related consumables – they will be provided quantities linked to vaccine ordered at the site, replenished in accordance with ongoing vaccine deliveries. This includes PPE as well as other items directly related to the vaccine such as syringes and diluents, depending on what is needed for the vaccine being used. Other consumables will also be replenished as standard, aiming to ensure over rather than under supply. There will be a process in due course for sites to indicate where they are receiving too much or (less likely) inadequate levels of replenishable supplies, likely to be coordinated via regions to the National Programme Supply Dedicated Customer Services Team, in order that regular deliveries can be adjusted accordingly.

Sufficient hard copies of vaccine-specific patient information leaflets will also be supplied centrally.

C. Data, payments and booking

C1. Recording the vaccination event

Good quality, timely vaccination event data is essential to support both national and regional coordination on vaccine supply as well as to enable appropriate surveillance of these new vaccines. Existing GP systems require varying levels of adaptation to enable the required information to be captured and flow to/from the relevant linked national systems such as the National Immunisation Management Service and support payment to practices. Initially, however, PCN sites will be required to use long-established pharmacy solutions for capturing vaccination data – Sonar (in London) and Pinnacle (in the rest of the country).

Sonar / Pinnacle are web-based systems and so no changes are required to practices’ I.T. equipment. Access to the systems will be provided free of charge to PCN designated sites, as will the associated training. Further information on the training will be forthcoming.

For MHRA surveillance purposes, it is essential that the vaccine type, dose and batch number are recorded accurately into the vaccination record. MHRA require that this be done by scanning of the GS1 standard 2d matrix barcodes supplied on the vaccine cartons. All designated sites will therefore require access to barcode scanners and for those that do not already have sufficient supply, this is included in the centrally procured and supplied list of items (see section B for more information). A suitable data connection (4G/wi-fi) will be required to access Sonar / Pinnacle via hand-held mobile devices when visiting care homes and housebound patients to administer vaccinations. PCNs can also access a tablet device where needed from the central list, upon request, to support roving vaccinations to care homes and housebound patients.

We appreciate that Sonar / Pinnacle will be unfamiliar to general practice, but we want to reassure you that they are easy to use, and that a comprehensive package of training, guidance and technical support will be available to you. A significant benefit of using Sonar / Pinnacle is that the vaccination event both for patients registered with practices within the PCN grouping, and patients registered with practices outside of the PCN grouping e.g. care home staff, can be recorded and a payment generated. There is no need for practices to also record the vaccination on the GP patient record as vaccination event data captured within Sonar / Pinnacle by PCN designated sites and other providers will flow back to the relevant GP patient record within 24 hours of the vaccination event. The National COVID-19 Vaccination Programme is working with GP system suppliers to ensure this is an automated process where this can be supported by the system, and that it is implemented as soon as possible. It should be noted that even within the automated process, practices will still need to review the incoming records of patients who have experienced an adverse reaction to a vaccine.

C2. Payments

Processes are being put in place to automatically generate payment to a nominated GP practice within the PCN grouping using vaccination event data recorded within Sonar / Pinnacle. The vaccination detail is captured for all patients on a standard template within Sonar / Pinnacle against a pre-populated ODS code of the nominated practice, which will act as an agent for payment and pass payments on to other practices within the PCN grouping as set out in the PCN grouping’s collaboration agreement. Through this process, the payment system can accommodate variation amongst PCN groupings, both in the number of PCNs/practices within the grouping as well as variation in the number of designated sites each grouping may have access to. It can also adapt to additional sites coming on stream in the future.

A template collaboration agreement will be provided to PCNs alongside the Service Specification and it will be for PCN groupings to agree how payments should be shared among constituent practices, for example, to reflect the workforce or managerial input provided by individual practices into the PCN grouping delivery model.

In situations (which are set out in the ES service specification) where the PCN grouping has been unable to complete the vaccination course and wishes to claim £12.58 for administration of a single vaccination dose, these claims will be made via a manual payment process.

Cash Flow

We are aware that some PCN groupings are concerned about the cash-flow implications of the period between the date that costs start to be incurred and receipt of the first payment for vaccinations administered, particularly in light of the fact that payment is made following the administration of the second dose. We will take action to ensure appropriate cash flow to practices.

C3. Call, recall and appointment booking

GP practices will be required to offer vaccination via call and recall at the appropriate time to patients which are on the GP practice registered patient list and fall under the announced eligible cohorts.

PCN groupings will be responsible for appointment booking at the Designated Site. As such, PCN groupings will need to put in place a local collaborative booking model that enables all practices within the PCN grouping to book patients into the designated site(s). Many practices already have the technical capability to access such a system and have been using it for some time to support extended access arrangements. However, we understand that a small proportion of practices may not have access to a collaborative booking system and we are in the process of confirming the solutions that will be available to these practices.

D. Workforce and Training

Workforce planning

It is expected that some PCN groupings will be able to resource the delivery of COVID-19 vaccination Enhanced Service from within existing, engaged workforce and we published last week guidance on prioritisation of workload. But we recognise that in many cases some additional support may be required.

This section sets out details of who can vaccinate patients, additional resources that may be available, training requirements and indemnity arrangements.

Expansion of the number of staffing groups who can vaccinate

We have identified three pools of staffs available to fill immuniser roles, as the legislation changes (Statutory Instrument (SI) to amend the 2012 Human Medicines Regulations) have been enacted. The three staffing pools with examples of each are listed below:

Please note starred healthcare professionals are able to administer prescription only medicines under a PGD.

In addition, PCNs can deploy Additional Roles Reimbursement Scheme (ARRS) staff (where permitted by legislation or protocol) as required to vaccinate. ARRS recruitment should continue with full funding entitlements remaining in place to continue to support practice teams.

Additional support that may be available

A national recruitment campaign is underway to recruit additional staff nationally to support the delivery of the COVID-19 vaccination programme including clinical vaccinating and non-clinical support roles.

The clinical roles have been developed to be generic (not specific to a professional clinical group), so that they can be taken by a wider pool of clinical staff.

It is the intention that we will be able to offer PCN groupings and other providers access to additional staff from this pool to support local efforts.

How can primary care draw down on additional resources?

Lead providers have been established in each ICS which will support PCN groupings to access workforce including volunteers from the national supply route. We will confirm with you soon who your lead is. PCN groupings should then inform their lead provider if they require additional resources to supplement their local workforce. They will seek to connect available staff with PCN groupings. The PCN grouping would then need to engage the individual. We will publish guidance separately on how these individuals should be engaged.

It is important to note that the workforce composition and skill mix (e.g. number and types of roles) used in a PCN or practice used to meet the requirements of the service should be determined locally. PCNs may have local alternatives or options available in place of recruiting additional staff, such as through the use of additional hours worked by existing staff. To this end, the final staffing model will depend on local workforce and registered population characteristics and the need to maintain safe staffing and clinical supervision arrangements.

Workforce return: FOR ACTION

We are asking PCN groupings to complete a return to help us understand workforce needs specifically:

• How many vaccinations can PCN groupings deliver per week within existing resources?
• How many additional vaccinations could PCN groupings deliver if additional resources were available? [We are assuming all PCN groupings will be able to deliver a minimum of 975 vaccinations per week within existing resources]
  To deliver this, please advise:
  • How many additional hours of vaccinators would be needed per week?
  • How many additional hours of non-vaccinators would be needed per week?

We have set up a very short survey for PCN groupings to submit this information via this link. Please complete the survey by Friday 4 December.

Staffing Training

Due to vaccine availability and legislative changes, a phased approach to workforce training is planned. It is intended that PHE immunisation training standards will apply as the minimum national standard for staff undertaking immunisation training as follows:

• https://www.gov.uk/government/publications/national-minimum-standards-and-core-curriculum-for-immunisation-training-for-registered-healthcare-practitioners.

COVID-19 specific vaccine e-learning has now been made available from PHE https://www.gov.uk/government/collections/covid-19-vaccination-programme

The above training package also includes vaccination programme guidance for healthcare practitioners, training slideset, vaccinator training recommendations, vaccinator competency assessment tool and Green book chapter. Product-specific training will be made available as vaccines come on stream.

Indemnity and Insurance

The Clinical Negligence Scheme for General Practice (CNSGP) provides clinical negligence indemnity cover for all staff engaged by a GP practice under the CNSGP Regulations. It covers NHS activities delivered by a Part 4 contractor under a Primary Medical Services contract (including an NHS standard contract with Schedule 2L – Provisions Applicable to Primary Medical Services), a Primary Medical Services sub-contractor or the provision of ‘Ancillary Health Services’ for a Part 4 contractor or Primary Medical Services sub-contractor such as a Local Enhanced Service.

The COVID-19 vaccination Enhanced Service is nationally agreed and as such is considered primary medical services for the purposes of cover under CNSGP. CNSGP will provide clinical negligence indemnity cover for all staff engaged or permitted’ by the contractor to deliver this enhanced service (including the additional staff listed above, and those that may be provided through voluntary organisations (e.g. St John’s Ambulance). There should be a documented agreement in place i.e. staff sharing agreement, honorary contract that makes clear that the staff are acting on behalf of the provider. NHS England will also provide a template collaboration agreement for practices to use that will cover the indemnity implications of practices vaccinating each other’s patients, their own practice staff and non-registered patients.

The main Medical Defence Organisations (MDOs) have confirmed that they will provide their members with access to medico-legal advice and support in connection with the delivery of the COVID-19 vaccination programme.

The contractor must have in place adequate indemnities and insurance in respect of any legal obligations relating to public and employer’s liability.

Annex B

Further details of training requirements for competent COVID-19 vaccinators and non-vaccinator roles (both clinical and non-clinical)

For staff to be signed off as being competent COVID-19 vaccinators they will need to receive/complete or equivalent to:

• A programme overview pack (incl. overview of COVID-19, COVID-19 vaccine(s), delivery models, roles and citizen journey)
• Immunisation training* (3 essential modules of the national e-learning programme and/or local training)
• COVID-19 vaccine-specific training (national e-learning and/or local training using PHE materials; F2F/virtual where possible to allow opportunities to ask questions)
• Anaphylaxis training* (national e-learning and/or local training; F2F where needed depending on skills and previous experience)
• Basic Life Support training* (F2F local training where needed depending on skills and previous experience)
• IM injection administration training (if inexperienced in vaccination; F2F local training)
• Training on administering under a PGD or national protocol (national PGD e-learning and local training on the national protocol using PHE material)
• NHS statutory/mandatory training (e.g. IG, IPC, H&S, fire safety, safeguarding)** (national e-learning or local training)
• A suitable period of supervised practice to be signed off by the clinical supervisor (if inexperienced in vaccination)
• Clinical Supervision needs to be provided for the entire workforce involved in vaccination.
• There should also be ‘on-site’ onboarding/induction to cover IT, workstation assessments, site flow, SOPs, site-specific PPE requirements, individual roles and how they relate to each other. This will need to be site-specific. An ‘onboarding checklist’ will be provided nationally to support this.
• All Clinical staff will also need to ensure that all of their role specific training is up to date

*unless completed in the past 12 months

**unless previously completed

All non-vaccinator roles (both clinical and non-clinical) will need to receive/complete the following:

• A programme overview pack (incl. overview of COVID-19, COVID-19 vaccine(s), delivery models, roles and citizen journey)
• Statutory/mandatory training (e.g. IG, IPC, H&S, fire safety, safeguarding) – as applicable and where not previously completed
• ‘On-site’ onboarding/induction to cover IT, workstation assessments, site flow, SOPs, site-specific PPE requirements, individual roles and how they relate to each other, etc. This will need to be site-specific so will be developed and delivered by regional and local teams. A draft onboarding ‘checklist’ is included in the appendix, we would welcome comments.
• Managerial Supervision needs to be provided for the entire workforce involved in vaccination.