Contents

• 1. Overall readiness
• 2. Estates readiness
• 3. Supplies readiness
• 4. Vaccine supply
• 5. Workforce and clinical readiness
• 6. Technology and data readiness
• 7. Patient engagement
• Annex A – Summary of key dates and activities
• Annex B – Copy of PCN Site Readiness Assessment for sites going live next week
• Annex C – technology equipment to be supplied for Existing, NHS PCN sites going live next week
• Annex D – technology equipment to be supplied for free to PCN New, non-NHS sites going live next week

Publication approval reference: C0944

To: PCN Designated Sites beginning operations week beginning 14 December 2020

Cc: Clinical Commissioning Groups

Monday 7 December 2020

Dear colleagues

Further to conversations with your CCG last week, we are writing to confirm that your PCN designated site will begin operation early next week (week beginning 14 December 2020). This means that you should start standing up your site in order to be ready to administer the Pfizer / BioNTech vaccine from Tuesday 15 and Wednesday 16 December following a delivery of vaccine the previous day. This letter follows our letter to all GP practices of 4 December, giving notice to PCN groupings that local vaccination services will start to come online on a phased basis. This letter should also be read alongside the information contained within our letter to all GP practices of 1 December.

You should start vaccinating patients aged 80 years and over as advised by the Joint Committee for Vaccinations and Immunisations (JCVI) from 15 December. This excludes any patients within this cohort who are totally housebound. Once further operational advice on vaccine handling has been agreed you should also start to vaccinate care home residents. We will be working with sites during the week of 14 December to ensure safe set up of this delivery model.

A summary of the key dates and milestones contained within this letter can be found at Annex A. We are also holding a webinar for those sites starting next week to help prepare you for standing up your local service, on Tuesday 8 December at 19:30 to 20:30 and which we will invite you to attend via email. Alternatively, you can register to attend this event here.

1. Overall readiness

• A standard operating procedure (SOP) for the COVID-19 vaccine deployment in community settings will soon be published here https://www.england.nhs.uk/coronavirus/covid-19-vaccination-programme/primary-care-guidance/. You should start working through this document and ensure compliance with all areas of the guidance.
• All individual practices within your PCN grouping need to opt into the Enhanced Service (ES) by notifying their CCG by email, by Tuesday 8 December. The ES specification is available here.
• We have also published an Indicative Collaboration Agreement, which the ES requires to be in place before the first vaccination is administered – you need to do this by Sunday 13 December (or 2 days before the date of vaccination).
• Daily site readiness assessment – for completion by CCGs
  We have established a Local Vaccination Service (LVS) online portal to capture PCN site information and monitor site readiness ahead of go-live. Each PCN designated site has been asked to identify two individuals to be provided with access to the portal. CCGs and NHSE/I Regions have similarly been asked to identify individuals requiring access.

From Tuesday 8 December, CCGs are asked to:

• Complete a daily readiness assessment for each of your sites on the LVS online portal. The readiness assessment comprises a series of yes/no questions to confirm estates/supplies/workforce/clinical/tech and data/legal readiness. Annex B includes a copy of the readiness questions. Readiness assessments will be aggregated at regional and national level for daily monitoring.
  • CCG nominated users should have received registration/log-in details.
  • PCN nominated users will receive registration/log-in details on Monday 7 December.

• CCGs will also need to complete a clinical assurance site visit and assessment of overall readiness by midday Friday 11 December. We will be holding a webinar to support CCGs and clinical assurers on Wednesday 9th December at 15:00-16:00.
• On the back of these visits, CCGs need to confirm to the national team by midday on Saturday 12 December via the online portal that each site is ready to start vaccinating patients from Tuesday 15 December.

2. Estates readiness

• In our letter to all GP practices on 1 December we advised designated sites to read the latest Care Quality Commission guidance to understand what, if any, changes you may need to make to your registration arrangements.
• Guidance on site preparation as found in the SOP should be followed.
• As explained in our letter of 1 December, GP IT systems as currently configured mean that Pinnacle, a long-established pharmacy solution, will be the Point of Care system used instead (see section 5 below for more information). Pinnacle is a web-based system, but it does require a suitable data connection (4G/WiFi). Your designated sites, particularly those who will be delivering clinics from new, non-NHS sites, should ensure that they have appropriate internet connectivity. Designated sites which are existing, NHS locations, will be able to use their existing Health and Social Care Network (HSCN) secure internet connection. We will also supply a 4G hotspot for all devices to use as a backup. For new, non-NHS sites, the NHSE/I Corporate IT team will contact you to arrange a survey as to whether you require broadband installation. Once sites start commencing roving vaccinations to care homes and housebound patients, we will supply 4G enabled laptops for roving vaccinators to use off-site. Broadband costs for non-NHS sites will be funded centrally.
• A specific COVID-19 collection capacity is being coordinated by commissioners for infectious and hazardous waste. Please contact them directly if you have not had notification of uplift arrangements.
• Offensive and general waste should be processed through existing arrangements in line with COVID-19 waste management standard operating procedure.
• For further information on clinical waste management please refer to the SOP.
• Your sites who will be delivering their clinics from non-NHS sites also need to ensure that they have a facilities management solution in place and a licence to occupy. More information is contained on the arrangements for non-NHS sites in our letter of 1 December.

3. Supplies readiness

• A list of equipment, consumables and PPE – the Supply Inventory List (SIL) – will be supplied, free of charge and delivered to the majority of Sites between Tuesday 8 – Saturday 12 December. Guidance on the SIL can be found here https://www.england.nhs.uk/coronavirus/publication/nhs-covid-19-vaccination-programme-equipment-and-consumables-provision-and-supply-excluding-public-health-england-and-corporate-it-provisions/. Note that resupply of any PPE and consumables included with the initial SIL delivery will be made to designated sites automatically, proportionate to future vaccine volumes – there is no need for sites to order these items directly.
• You will be given 24 hours’ notice before your delivery is made and given an AM or PM delivery slot. Sites do not have to order any items from the SIL – all items will be included with your delivery. Deliveries will be made between 08:00 and 18:30 on weekdays, and between 09:00 and 16:00 if required on Saturdays. Two members of staff need to be available to receive deliveries.
• For PCN sites using existing premises, the items that will be supplied are listed here https://www.england.nhs.uk/coronavirus/publication/appendix-3d-local-vaccination-services-nhs-items/
• For new, non-NHS sites, there is no expectation on practices to transfer physical resources from any GP practices to off-site facilities where this would interrupt normal services. The items that will be supplied to non-NHS sites are listed here https://www.england.nhs.uk/coronavirus/publication/appendix-3c-local-vaccination-services-non-nhs-items/
• A separate delivery of an under-counter sized refrigerator will be made to every site between Tuesday 8th – Saturday 12th December. You will be given 24 hours’ notice before your delivery is made. Deliveries will be made between 08:00 and 18:30 on weekdays and between 09:00 and 16:00 on Saturdays.
• Sites will also receive items designed for roving vaccinations (e.g. care home residents) – these are listed here https://www.england.nhs.uk/coronavirus/publication/appendix-3e-pcn-roving-items/. To support roving vaccination to care homes and housebound patients, a freezer will be supplied for free to sites to store gel packs for cool boxes to take the vaccine off-site.
• Public Health England (PHE) has created a number of leaflets for patients. These are set out in the PHE document entitled “Covid-19 vaccination programme publications: A guide for use”, which explains when to use each leaflet. You can also view and download all the leaflets on a WeTransfer site here: https://we.tl/t-plD5HpoimJ, as well as view the posters which have been created to support the vaccination programme. Please ensure relevant staff familiarise themselves with the content of the leaflets. The leaflets are available on https://www.healthpublications.gov.uk/Home.html, as well as under “Leaflets and posters” at https://www.gov.uk/government/collections/covid-19-vaccination-programme The leaflets will also be available soon in a number of different languages, as well as Braille and Easy Read versions, and a British Sign Language video.
• We will deliver an initial quantity of leaflets to your site and will advise you when to expect this delivery and will confirm the ordering process for subsequent batches.
• Some other items that may need to be sourced locally are listed here https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0914-covid-vacc-sil-appendix-appendix-2-locally-provided-products.pdf. If you consider that you need any of these items, or other items not on any of the lists, we recommend that you speak to your CCG to understand whether there is existing local stock available. If not, sites should agree with CCGs to purchase items directly, and which would later be reimbursable as part of the £20m we have made available nationally for additional reasonable costs to support site set-up.

4. Vaccine supply

• Delivery of your initial vaccine supply will take place the day before you start vaccination. All Sites going live next week will receive 975 vaccines in their initial delivery. Vaccine-related consumables (e.g. syringes, diluents) and post-vaccination record cards will be delivered together with the vaccine, in the appropriate quantities. We will confirm by email with each site their specific vaccine delivery date by the end of today.
• To facilitate smooth delivery of the vaccine, please ensure that your named, registered Health Care Professional (HCP) who will receive the vaccine is there on the day. Designated sites will be mapped into the delivery route for vaccine supply. Deliveries will be made between 08:00 and 18:30 on weekdays and between 09:00 and 16:00 on Saturdays.
• Vaccines need to be used quickly in the days following delivery and you should start your vaccination clinic as soon as possible. We expect the remaining vaccine shelf life once delivered and stored at 2-8°C to be in the range of 86 hours (3 days 14 hours) to 99 hours (4 days 3 hours). Shelf life will be clearly marked on the vaccine box label. Further guidance on the appropriate Cold chain procedure can be found in the SOP. Note that it is essential that sites have sufficient vaccine storage space at 2-8 °C for up to 5 days.
• Sites that receive the initial vaccine delivery on 14 December will receive their corresponding vaccine delivery for dose 2 on Monday 4 January 2021. Sites that receive their initial vaccine delivery on 15 December will receive their corresponding vaccine delivery for dose 2 on Tuesday 5 January 2021.
• Vaccine resupply orders will be made via the national ordering system. Sites will have received registration and log-in details for their account.

5. Workforce and clinical readiness

• PHE will publish the Patient Group Direction (PGD) for the vaccine this week, and so the PGD will be in place in time for when sites start vaccinating patients.
• Designated sites will need to consider how best to deploy their workforce as well as seeking additional capacity as required to support local vaccination services for the community. Further guidance on workforce planning and skill-mix is included in the SOP, as well as advice on preparation, risk assessment and a sample operating model for delivering your local vaccination service. You should also refer to the workforce section in our letter of 1 December which set out the training requirements for competent COVID-19 vaccinators and non-vaccinator roles. 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.
• We anticipate that your sites will for the most part be relying on their existing workforce initially. You may also find it helpful to connect with local government, community and voluntary sector colleagues to understand what other support could be mobilised locally.
• Information on indemnity and insurance is also contained within the 1 December letter.
• Please note that there is a requirement for a GP to be available on site for each vaccination session/clinic. You must also have a clinical governance process in place, an identified lead practice to manage the workforce, safe staff arrangements and an operational lead for the site.
• We recommend that your sites finalise their workforce arrangements and have any new, temporary staff in place by Thursday 10th December.
• 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
• In addition, COVID-19 specific vaccine e-learning is available from PHE, including vaccinator training recommendations https://www.gov.uk/government/collections/covid-19-vaccination-programme
• Your sites need to complete all their training requirements by Monday 14th December.
• See section 5 below on Technology and Data for further training requirements around the Point of Care System, Pinnacle.

6. Technology and data readiness

• A list of technology equipment which will be supplied to all sites for free by NHSE/I Corporate IT team is attached at Annex C (for existing, NHS sites) and Annex D (for new, non-NHS sites). Sites will be supplied with sufficient technology equipment with the intention that staff will not have to use existing devices in use for business as usual work. Staff will not need a login for the devices. A tablet will also be supplied as an additional, backup device.
• All devices supplied will have limited access to relevant websites, which will be:
  • British National Formulary;
  • National Institute for Health and Care Excellence;
  • GP Notebook;
  • Pinnacle and Insights;
  • NHS England information and guidance for Primary Care on the Covid-19 vaccination programme.
• Staff at sites may occasionally want to access a patient’s Summary Care Record. Staff will also need to access the appointment book for the clinic. One laptop will therefore come with the GP IT clinical systems (EMIS, TPP, Vision and Microtest), as well as a VPN token (for use if a HSCN connection is not available) and smartcard reader, to enable occasional access to the SCR and access to the day’s appointment book via the relevant clinical system which has been used to create it.
• The delivery window for devices will be between 08:00 and 18:30 on weekdays and 09:00 and 16:00 on Saturdays and you will be given 24 hours’ notice of the delivery date. For existing NHS sites, we expect that staff will already be available to receive the delivery. For new, non-NHS sites, please ensure that at least one member of staff is at the site in order to receive the delivery.
• Initial and ongoing IT support will be provided – we will provide further detail shortly.
• GP Connect is available to allow patient record sharing and appointment booking across PCNs to support the rollout of the COVID-19 vaccination. The team are running webinars to help PCNs to set up their appointments to share, book into a designated site’s appointments and to help designated sites to understand how to run their vaccination clinics, including use of Pinnacle to record the vaccination. Registration links for the webinars are being shared via the Primary Care Bulletin and more information can be found on the GP Connect website: https://digital.nhs.uk/services/gp-connect
• Pinnacle is the Point of Care (POC) system that PCN sites will use to record the vaccination event. Access to Pinnacle, which is web-based, will be provided free of charge to PCN designated sites, as will the associated training. (Please note that in our 1st December letter, we announced that there would be two POC systems – Sonar and Pinnacle – but this has now been consolidated into use of Pinnacle alone.)
• Pinnacle access will be dependent on the set up of some new ODS codes and infrastructure which the programme is carrying out, based on information already collected. There are some cases where clarification is being sought, but otherwise no action is required on your part.
• As part of user onboarding, we will be asking regional teams to confirm the details of one or two system administrators per PCN designated site who will be set up on Pinnacle with delegated permissions to add and manage end-users.
• Once this information has been processed, administrators will receive Pinnacle log in details by email and must log in within three calendar days for security reasons. Logon details are expected to be provided to sites by Thursday 10th December.
• We recommend that your sites set up additional Pinnacle accounts for clinical and non-clinical end-users once initial log in details have been received.
• The training for the Pinnacle system administrators will be via a ‘How-to’ comprehensive user guide explaining step-by-step how to set-up and manage the user accounts at the vaccination site. Additionally, for individual system user training, Pinnacle have made available user-guide videos. These provide a step-by-step walk-through the system providing everything that is needed to operate the Pinnacle system.  We will let your sites know how to access these training resources soon.
• We recommend that all relevant staff members complete their Pinnacle training by Monday 14th December.
• Regional teams have also been asked to confirm and collate a minimum of two users within the PCN Grouping that will be issued with account logins for Manage Your Service (MYS), which will support the flow of payment data. These details should be confirmed with your regional teams at the earliest opportunity.

7. Patient engagement

• GP practices know their local populations and are responsible for generating patient lists based on the priority cohort definition, which for sites going live next week is ‘All those 80 years of age and over’ (excluding the housebound). If your site potentially has more than 975 patients over 80 years who may wish to be vaccinated, and you need to prioritise which patients should have access to the first supply of vaccine to your designated site, then you could consider the following
  • Age 80 or over;
  • Co-morbidities;
  • Ethnicity.
• PCN groupings will be responsible for appointment booking at the designated site.
• GP Connect are holding a series of webinars on how to set up appointments collaboratively. For EMIS Web and TPP SystmOne the next webinars will be on Tuesday 8th December at 13:30 and 15:00 respectively. You can join the webinars here https://crm.digital.nhs.uk/clickdimensions/?clickpage=pqbzc8weeuoewanoodgfq
• As set out in the training module for this vaccination, informed consent is appropriate and this can be verbal (implied). As part of the cohort identification process, you should also highlight any patients who may lack capacity to give their consent at the time of vaccination and refer to the SOP for guidance on how to proceed. Note that consent can be recorded within the Pinnacle system by the following parties: patient; parent, partner or relative; healthcare lasting power of attorney; court appointed deputy; independent mental capacity advocate (IMCA) and clinician using best interests process of Mental Capacity Act.
• It is essential we vaccinate in line with JCVI guidance and ensure minimal wastage. PCN designated sites should therefore ensure that after all efforts to ensure patient attendance, any unfilled appointments or residual supply of vaccine are used to vaccinate practice and PCN staff within the PCN grouping, who have been identified at highest risk of serious illness from COVID-19. Healthcare providers have been undertaking staff risk assessments throughout the pandemic to identify such individuals. Please note that the PHE post-vaccination patient information leaflet advises any women of child-bearing age not to get pregnant for two months after their second dose of the vaccine.
• Your combined PCN grouping patient list will inform the local call and recall exercise. We recommend that your first call/recall communication is sent to patients by Wednesday 9th December or 6 days prior to the start of your vaccination clinic.
• We will share with you patient template letters this week. Please note that invitations need to include multiple key fields, including:
  • Information on the requirement to book appointments for dose 1 and 2 at time of booking. This will be standardised nationally. Dose 2 of the Pfizer / BioNTech vaccine should be given 21 days after dose
  • Direction to where and how the individual should book their appointment.
  • Clear explanation of where the vaccination site will be (and why if not a local practice) and access information – e.g., transport, parking, accessibility, translation.
• We recommend that you start booking patients into your vaccination clinic from Thursday 10th December at the latest (or 5 days before the start of your vaccination clinic). PCN sites will be responsible for checking that all eligible patients have an appointment and issue a recall invitation or re-contacting the patients where they have not.
• You should send booking reminders before each appointment for dose 1 and 2. Individuals should also be informed during booking of the process for rebooking/changing appointments if necessary.
• Please refer to the SOP for further guidance on booking and communications as well as on health inequalities, inclusion health and how to ensure your local vaccination service is accessible to the whole population that you serve. Local government together with community and partner agencies may also be able to help you improve access and vaccination uptake among your patient population. You should also refer to the JCVI’s ‘Annex A: COVID-19 vaccine and health inequalities: considerations for prioritisation and implementation’ guidance here https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-2-december-2020
• NHS England is responsible for processing your personal data for the purposes of the national vaccination programme. To find out more, you can access our privacy notice at: https://www.england.nhs.uk/contact-us/privacy-notice/ or search for “NHS England Privacy Notice” in your browser. It is recommended that patients are directed to this link within any communications.

We hope that the information contained within this letter is helpful and clear. Can we thank you again for your incredibly quick and positive response to the call to mobilise the COVID-19 vaccination programme. If you have any outstanding questions, please direct them to your CCG, who will if necessary seek advice from NHSE/I region, with whom the national team is in regular and close contact.

A dedicated Vaccination Service Helpdesk is being set up, offering telephone and email advice from 06:00-22:00 every day, including bank holidays. We will share details with you soon. In the meantime, for any queries that your CCG is unable to answer, please contact our mailbox england.cov-primary-care@nhs.net

Many thanks

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 – Summary of key dates and activities

Annex B – Copy of PCN Site Readiness Assessment for sites going live next week

CCGs will need to complete on a daily basis on the LVS online portal for site readiness assessment and vaccine ordering (Foundry) from Tuesday 8 December

Annex C – technology equipment to be supplied for Existing, NHS PCN sites going live next week

Annex D – technology equipment to be supplied for free to PCN new, non-NHS sites going live next week