Immunisation services and large-scale vaccination delivery during COVID-19

Introduction and background

Vaccination is an essential clinical service that should continue during the COVID-19 pandemic. The RCN guidance outlining the key principles for maintaining the national immunisation schedule has been incorporated into the information in this resource.

As a result of the COVID-19 pandemic there has been considerable discussion about offering vaccination in novel settings such as health care centre car parks, other open spaces or temporary structures such as gazebos to reduce the time people are in the surgery. Alongside this there is recognition for a need to offer large scale vaccination services particularly to support the influenza vaccine programme for 2020/2021 and COVID-19 vaccines as they become available. The ‘usual’ vaccination premises and staff are unlikely to be able to cope with this increased need for capacity alone.

Large scale vaccination plans are being developed locally and with engagement with multi-professional colleagues across the system; primary care, general practice, pharmacy, community services, care homes, school health and potentially linked to acute services for example A&E and outpatients. The local population needs, infrastructure availability, service capacity and demand all need careful consideration.

Routine immunisation services

The advice from the JCVI is that childhood vaccination, should continue during the COVID-19 pandemic. 

The advice has been reiterated by Public Health England and Public Health Wales. The Royal College of General Practitioners and the World Health Organisation (WHO) have warned that disruption to immunisation programmes during a pandemic can result in an increase in vaccine preventable diseases making continuing to immunise children even more important.

We know from experience that falls in immunisation rates lead to increases in cases of vaccine preventable diseases and deaths.

This RCN guidance outlines the key principles for maintaining the national immunisation schedule, as well as large scale vaccine delivery. See the ‘Top Tips’ and further information section.

The RCN immunisation clinical resources provide further guidance and information on vaccine administration.

Overview for planning of large-scale vaccination services

Vaccination in temporary open-air venues and structures can pose potential risks, such as difficulties in maintaining vaccine cold chain, waste management or following infection prevention and control procedures. Buildings with the capacity for large scale vaccination options such as sports and leisure centres, community centres and religious venues may offer the potential to facilitate a mass throughput of people. Providing certain logistics are thought through and a local risk assessment carried out they can be a valuable option.

The aim of this guidance is to make sure the services are reactive to the needs of the population while remaining safe and accessible to all. This guidance can be used to support the setting up of mass vaccination centres but also for scaling up of current immunisation service provision. See also the RCGP logistical guidance Delivering Mass Vaccinations During COVID-19 A Logistical Guide for General Practice.

Planning and risk assessment process

There are some key considerations for staff as part of a risk assessment process for delivering vaccination services in non-clinical settings:

  • Any risk assessment needs to be recorded, shared and regularly reviewed and updated

  • Each venue will need a risk assessment as some may not be appropriate for certain groups e.g. vulnerable adults such as those with Learning Disability and dementia. Alongside this the risk assessment needs to consider potential challenging behaviours where-local systems need to have options for making reasonable adjustments available.
  • Local plans should be developed with individual equality impact assessments
  • There needs to be consideration to ensure safety easy access to sharps disposal (see under top tips safe vaccine administration).
  • Make sure staff are able to work safely avoid the need for any continuous bending/stooping and the risk of back injuries.  Consider staff rotation and rest periods for immunisers.
  • Support people with cognitive impairment who may be more comfortable receiving health care in familiar environments. Local systems to have options for making reasonable adjustments available where needed, including providing immunisation in the persons place of residence, if this is the most appropriate option.
  • Assess the ease of access and transport routes to the venue; traffic flow environmental risks e.g. weather conditions rain/ice, heat.
  • For any open-air venues, consider how to manage weather, i.e; extremes of temperature or wet weather.

  • There need to be clear lines of accountability and senior clinical leadership to ensure there is appropriate governance of the service and coordination with the existing systems and services.
  • Registered health care professionals must abide by their professional code of conduct (e.g. NMC Code of professional conduct (NMC, 2018), wherever they provide care alongside local policies and procedures.
  • Any regulatory requirements have been met (e.g. CQC requirements for a new premises to deliver services).
  • Employers must ensure that the appropriate indemnity arrangements are in place for all staff wherever they are working (see section on Indemnity)
  • Make sure staff understand their role in relation to safeguarding for both adults and children, including those people within vulnerable groups.
  • Make sure staff have undergone mandatory training for giving the specific vaccine. (see section on education and training needs / who can vaccinate).
  • While anaphylaxis following vaccination is rare there needs to be a clear process for managing post vaccination anaphylaxis and any other adverse events (see info on safe vaccine administration and follow up in the top tips section).
  • There is no need for a specific observation period after vaccine administration. If the individual is driving immediately such as in drive through centre they should wait 15 minutes before driving. (JCVI minutes)
  • Ensuring the health and safety of staff and patients including mitigation of risk of needlestick injury, personal safety and access to appropriate personal protective equipment and the security of equipment on site.
  • Consideration of how to make sure equipment and supplies are transported to and from the venue. This includes the vaccine storage and transportation requirements (see further information under ‘vaccine storage’).
  • Make sure there is provision for the safe and appropriate disposal of clinical waste (e.g. used PPE, disposable hand towels). The RCN management of waste from health, social and personal care (currently under review) and HSE resources for management of waste publications provide further guidance.

  • Ensure there is access to patient’s records as part of the pathway and provision for good documentation and record keeping.
  • Make sure there are processes to gain patient consent and ensure confidentiality alongside maintaining the individual’s right to privacy and dignity.
  •  Access to appropriate information in easy read or other languages where appropriate to support people with disability or where English is not a first language.

Education and training needs of immunisers

The National Minimum Standards (NMS) for immunisation training is applicable for any registered health care professional and sets out the education and competencies requirements for all vaccinators:

The Public Health England (PHE) guidance are applicable in Wales. 

Further UK country specific guidance for immunisation education is available from: Northern Ireland and specific trusts; Scotland ‘Promoting Effective Immunisation Practice’ and Wales  and Public Health Wales e-learning.

The RCN have developed guidance on vaccination provision by health care support staff, e.g. nursing support workers (Healthcare Support Workers HCSW), working under the delegation of a registered health care professionals. This guidance applies in England and Wales. There is separate guidance in development for Scotland. HCSW do not vaccinate in Northern Ireland. There is separate RCN guidance on the role for nursing associates in England.

These take into consideration the legal medicines management requirements and need for professional and personal accountability and delegation processes.

See the below RCN publications:

Indemnity

The Clinical Negligence Scheme for General Practice (CNSGP), the similar scheme in Wales, General Medical Practice Indemnity (GMPI), and local arrangements in Northern Ireland and Scotland, provide clinical negligence indemnity cover for all general practice staff, including General Practice Nurses (GPNs), undertaking NHS primary medical services functions under a contract.

This includes Directed Enhanced Services (DESs) such as flu vaccinations which are deemed part of a practice’s primary medical contract for the purposes of cover under indemnity schemes. The indemnity cover extends to the provision of such primary medical services functions, regardless of the location from where a service / function might be provided or administered to a patient.

This could include the provision of a flu vaccination ‘clinic’ for its registered patients at a neutral location off site from the GP practice, for example in a church or school hall.

Medicines management

The regulation of medicines is defined under the Human Medicines Regulations HMR 2012 Vaccines are classified as Prescription Only Medicines (POM) which means they need to have the appropriate authorisation in order to be supplied and or administered to a patient.

Under emergency legislation changes to the HMR a further alternative mechanism has been introduced to allow Influenza and COVID-19 vaccines to be administered under a National Protocol. There are also changes to the staff who can use a Written instruction, see under alternative authorisation.

This is the traditional way that medicines are supplied and/or administered to a named patient/patients. The term prescription is generally used in practice and indicates it is written by a prescriber.

A PSD provides a written instruction to another healthcare professional to supply or administer a medicine directly to a named patient or to several named patients.

The PSD is often recorded in the patient’s electronic patient record after individual assessment from a prescriber.

See: Questions about Patient Specific Directions (PSD) from the Specialist Pharmacist Services.

There are some specific exemptions within the legislation which are relevant to providing vaccines and allow for alternative authorisation processes for the supply and or administration of a POM in certain situations or circumstances. These include:

Patient Group Direction (PGD):

  • Allows for the supply and/or administration of a POM by some registered health care professionals, as defined under schedule 16 of HMR 2012 legislation.
  • Registered nursing associates (NA) and other nursing support workers are not listed in the legislation and cannot supply and/or administer medicines under a PGD.
  • A PGD describes the complete process and practitioners cannot delegate aspects of the care under a PGD, or deviate from the specified requirements.
  • PGDS can be developed for use across multiple organisations Patient Group Direction (PGD) use in a service provided by multiple organisations.

Written direction:

  • Allows for POMs to be supplied and/or administered by a registered nurse in the course of an occupational health scheme OHS the written instruction is developed with a doctor. The details are explicit under schedule 17 of HMR 2012 legislation.
  • The HMR amendments allow for other registered professionals to use written instructions within NHS or local authority provided OHS. (This includes registered nursing associates in England).
  • The Specialist Pharmacy Service (SPS) have a standard template for Written Instruction for the administration of seasonal ‘flu vaccination and advice for PGDs and Occupational Health Services. There will be a similar national template for COVID-19 vaccines.

National protocol:

  • Legislative changes to the Human Medicines Regulations (HMR) allow for vaccine delivery under a protocol. 
  • The aim of the protocol is for the safe administration of a vaccine to those eligible in the population.
  • It allows for delegation and administration of vaccines under a separate mechanism to a PSD or PGD
  • The protocol allows for different people to carry out various functions of the process such as; clinical assessment and gaining patient consent, vaccine administration and administrative support.

Emergency medicines:

  • Certain medicines can be administered in an emergency without the directions of a prescriber. This includes adrenaline 1 in 1000 which can be administered in an emergency for the purpose of saving life and this is defined under schedule 19 of HMR 2012 legislation.

The RCN medicines management provide additional resources and information on PGDs PSDs and medicines administration.

Top tips

  • Contact the individuals due for the vaccination by text, letter or call and explain the process (consider in advance any reasonable adjustments that may need to be completed)
  • Where appropriate ensure the vaccination details and appointment is shared with the person’s representative and or powers of attorney / carers, or in the patient passport, for example for people with learning disability.
  • Make sure people understand that they must not be symptomatic for coronavirus and/or in period of isolation as a contact – if this applies then they will need to wait before scheduling an appointment as soon as they are ready to do so.
  • Recall individuals who do not respond and make sure they are given opportunities to have alternative appointments and opportunities to discuss any issues or concerns.

  • Recognise that people may be anxious to attend clinics and health centres when they have been advised about social distancing.
  • Have clear signage in the clinic to support people.
  • People may also have concerns about vaccines so despite busy clinics make sure the environment remains welcoming so that individuals will want to attend and feel that they can have their questions and concerns addressed.
  • It is important to reiterate the importance of vaccination. Having a call and contact will help as a reminder for the vaccination appointment.
  • Reinforce the message that if they decide to not have the vaccination it is ultimately their decision but they will remain vulnerable to diseases.
  • Ensure open access by making sure that they know they can contact you at any time to discuss or arrange further appointments.

  • Ensure all members of the team are aware of the importance of vaccination so that when people ask, they are directed to the correct information and/or to other appropriate support.
  • Provide reception staff and other members of the team with relevant and appropriate leaflets and reputable web sites to direct people to including easy read and information in other languages.
  • Consider the potential for domiciliary vaccination for patients with particular care needs or for example in residential care or nursing home settings.

  • This will vary considerably depending on the vaccines being offered.
  • Consider telephone consultation for pre-vaccination discussion if this is needed and have post-immunisation advice available on web sites and in leaflets. Ensure any reasonable adjustments are planned in advance as relevant (i.e.- Interpreters/language line).
  • Consider sending out relevant information by text or email or direct individuals to your web site.
    • Manage flow of patients:
    • Consider one-way system around the venue to support social distancing.
    • Reception administration staff able to welcome people.
    • Waiting area for people to read though information and start completing pre vaccination checks.
    • Clinical area for vaccination procedure.
    • Post vaccination ensure follow up advice and for patient’s arrangements to collect coats bags etc.

Managing infection and prevention control requirements and ensuring the patients as well as the staff are safe:

  • Make sure individuals are advised not to attend appointments with possible or suspected COVID-19 infection.
  • Maintain social distancing wherever possible. Patients and members of the public entering and health care venues should be advised to use face coverings in line with government advice.
  • Encourage individuals to wash their hands or use alcohol gel on entering the venue.
  • Refer to local policy regarding cleaning. Consider decontamination, with normal detergent, of any touched surfaces between patients and thoroughly clean at the end of the clinic. Use sensible pragmatic precautions based on individual clinic and patient risk assessment. See the recommendations in the IPC guidance.
  • Use of appropriate and proportionate PPE following the relevant guidance.
  • Effective hand hygiene is paramount See: RCN poster. Gloves and aprons are not necessary unless there is a risk to the healthcare worker, for example, when there is (anticipated) exposure to blood/body fluids or non-intact skin, see the RCN See: RCN's Tools of the trade.
  • Advise people to attend alone if at all possible and to wear a face covering during the procedure. However, be flexible and ensure any relevant and reasonable adjustments are put in place for children or those who need support.

  • The vaccine Summary of Product Characteristics (SmPC) which can be found on the electronic medicines compendium website will include the detail on vaccine storage requirements and vaccine preparation prior to administration.
  • •While most vaccines used in the UK are recommended to be stored within the range of +2°C to +8°C - the ‘Cold Chain’. There are some specific storage requirements for some COVID-19 vaccines. These are detailed in the specific product information or Summary of Product Characteristics (SmPC).
  • Consider access to fridges on site for vaccine storage.
  • Cool boxes can be used but the detail on how to transport vaccine and ensure they stay within the cold chain needs to be considered.

  • Make sure there are appropriate equipment for the safe disposal of sharps disposal and other waste disposal see Chapter 3 in the Green Book.

  • Ensure all data is recorded on the patient’s clinical record and personal held record where appropriate, i.e. the red book for children.
  • Record keeping is an essential part of clinical practice and it is a professional responsibility to make sure information on patient care and treatment is recorded as soon as possible and that it is clear and accurate, see NMC Code
  • There may be times when vaccines are given and there is no immediate access to the patient’s clinical records. Where this happens there should be a thorough risk assessment carried out. It is recommended that the details are recorded on a paper form or template at the time, this should include:
    • Patient details; Name, DOB and or NHS number address and ethnicity.
    • The vaccine details; name and batch number.
    • Date and the venue where the vaccine is given.
    • The site where the vaccine is given and the route of administration.
    • Vaccine administered by; including name, signature and designation.
  • Where electronic data into the patients clinical record happens post clinic; the data inputting process on to the clinical records can be undertaken by administrator support. This record should include the date the data entry was made and the administrator named, to enable audit and any look-back.
  • Governance process requires a scanned copy of the paper form is saved on to the practice system in case of need to cross check or retrospectively access.
  • Conduct a small audit of a number of records to be assured data is inputted correctly.

  • Recipients of any vaccine should be observed for immediate Adverse Drug Reactions. There is no evidence to support the practice of keeping patients under longer observation in the GP surgery.  See: Green Book Chapter 4.
  • If the individual is driving immediately such as in drive through centre they should wait 15 minutes before driving. (JCVI minutes)
  • Provide additional guidance on the vaccine, expected side effects and what to do (such as take paracetamol and rest). – this could be sent via email or text links.  
  • If fever is still present 48 hours after vaccines or if patients are concerned, they should seek advice from their GP or NHS 111.