A number of practices have raised queries with the LMC regarding this issue. The following information provides additional background together with further advice for all practices.
The primary reason this issue has arisen is because the UKHSA (UK Health Security Agency) has rewritten and updated its guidance on the training required for healthcare staff involved in delivery vaccination programmes.
UKHSA has described two groups of staff who provide healthcare; those who are registered on a professional register, such as GPs, nurses and pharmacists, and those who are not, described as Healthcare Support Workers (HCSW). Although the UKHSA guidance recognises the significant expansion of roles within national vaccination programmes, including those given within General Practice, it also notes that “it is outside the scope of practice of a HCSW to undertake a clinical assessment for vaccinations, take informed consent or work to a PGD (Patient Group Direction)”. The UKHSA also advises that HCSWs should not deliver injected vaccinations to infants and pre-school age children.
Colleagues will be aware that under their Primary Medical Services Contract (GMS, PMS and APMS Contracts) GPs should ensure any staff delegated to undertake work should be appropriately trained to do so. The UKHSA advice in relation to HCSWs involved in vaccination administration is that: “It is recommended that only experienced HCSWs take on a role in administering vaccines. It is expected that these HCSWs will have achieved education and training to Level Three of the Qualifications and Credit Framework (QCF) or equivalent and that they would be working at Level Three or above of the NHS Career Framework”
PGDs are also written with the requirement that only competent, trained professionals can use them; the UKHSA produces template PGDs, for use across the NHS.
HCSWs, as unregistered professionals, can only administer prescription only medicines where they have been prescribed or where a Patient Specific Direction (PSD) in place. If a PSD is in place the responsibility for obtaining informed consent for the prescribed item, in this case the vaccine, lies with the prescriber. HCSWs can obtain agreement, and it would be good practice for this to occur, that the individual does “consent to proceed” with the administration of the vaccine for which informed consent has already been obtained. Informed consent and “consent to proceed” do not need to occur simultaneously or at the same location but HCSWs undertaking vaccination should have concurrent access to a registered health professional for support and advice if necessary.
The updated “Green Book” Chapter 2 (Consent) states that “Whilst it is outside the scope of healthcare support workers to seek informed consent to treatment with a vaccine, they may seek consent to administer a vaccine for which informed consent has been gained by a registered healthcare professional.”
Updated UKHSA guidance emphasises that informed consent should not be regarded as occurring at a single point in time, but is a process culminating, in this case, with the vaccination(s) being given. Informed consent means individuals are provided with the necessary information and support to make a decision, or those responsible for individuals who cannot make a wholly independent decision also have this information and that the individual in question is engaged as much as is feasible. There is no requirement for such a consent to be in writing, but it would be good practice to document in the patient’s records any discussions or queries that a patient raised in relation to their vaccination.
Under current guidance, HCSWs may undertake:
- Vaccine administration, where a suitable legal mechanism is in place, a Registered Professional is available and the HCSW is trained, competent, and supervised; suitable vaccines may include influenza, shingles, pneumococcal, and COVID-19 vaccines.
- Check if patient is well on the day, and consent to the technical process of vaccination (if patient feels unwell on day guidance to be sought from Registered Professional).
- Clinical assessment of vaccine suitability is the responsibility of the prescriber, who would then document this via the PSD mechanism.
- Supportive roles in vaccination delivery, including:
- Preparation of vaccination areas and equipment.
- Monitoring and maintaining the cold chain.
- Ordering, receiving, and stock control of vaccines.
- Supporting patient flow and observation post-vaccination.
- Communication and support, including reassurance, basic information provision, and escalation of patient queries to a Registered Professional.
HCSWs should not:
- Undertake a clinical assessment of vaccine suitability as this is a Registered Professional responsibility.
- Work under a Patient Group Direction (PGD).
- Prescribe or authorise vaccine administration.
- Administer injected vaccines to:
- Individuals with complex medical or vaccination histories (unless specifically assessed and authorised by a Registered Professional).
- Individuals requiring travel vaccinations (which require a travel health risk assessment by a Registered Professional).
- Respond independently to clinical questions or concerns about vaccination.
In order to facilitate the process of informed consent by patients, it would be helpful to reference information that is available to patients if they are invited to a vaccination, for example, by text, email or, if feasible, other correspondence. In addition, there should be a clear opportunity to raise any questions patients may have with a registered professional. Examples of what is available can be seen on the health resource library
For example, the link about the annual flu programme, which contains individual links that practices could use when communicating with patients.
By ensuring patients have access to the information they need to give their informed consent, and the opportunity to raise any questions, before the vaccination event, a key part of the consent process can be undertaken.
Dr Julius Parker, Chief Executive