Coronavirus (COVID-19) vaccine - Comirnaty® (mRNA Vaccine, Pfizer/BioNTech): national protocol

4. Characteristics of staff

The Provider is responsible for the designation and authorisation of persons within the classes set out below permitted to administer medicinal products under this protocol. In doing so the provider must establish that those persons

a) demonstrate appropriate knowledge and skills to work under the National Protocol for the supply/administration of COVID-19 vaccine.

b) have met the requirements of the NES Proficiency document - COVID-19 vaccine administration for registered staff or the NES Proficiency document –COVID-19 vaccine administration - Healthcare support workers as appropriate.

Classes of persons permitted to administer medicinal products under this protocol

This protocol may be adhered to wholly from assessment through to post-vaccination by a single appropriately specified registered healthcare professional. Alternatively, multiple persons may undertake specific activity stages in the vaccination pathway in accordance with this protocol.

Activity stages of the vaccination pathway under this protocol

Stage 1

a. Assessment of the individual presenting for vaccination

b. Provide information and obtain informed consent

c. Provide advice to the individual

d. Capacity for under 16's should be assessed in line with current practices for existing childhood vaccination programmes

Registered Healthcare Professionals Only

Stage 2

• Vaccine Preparation

Registered Healthcare Professionals, non-registered professionals or non-registered Armed Forces staff

Stage 3

• Vaccine Administration

Registered Healthcare Professionals, non-registered professionals or non-registered Armed Forces staff

Stage 4

• Record Keeping

Registered Healthcare Professionals, non-registered professionals or non-registered Armed Forces staff

Providers are responsible for assessing the competency of, designating and recording the names of all those persons permitted to supply and administer under this protocol.

The following specified registered healthcare professionals are permitted to administer under the protocol subject to the requirements set out below:

• Nurses and midwives currently registered with the Nursing and Midwifery Council (NMC).
• Pharmacists currently registered with the General Pharmaceutical Council (GPhC).
• Chiropodists/podiatrists, dieticians, occupational therapists, operating department practitioners, orthoptists, orthotists/prosthetists, paramedics, physiotherapists, radiographers and speech and language therapists currently registered with the Health and Care Professions Council (HCPC).
• Dental hygienists and dental therapists registered with the General Dental Council.
• Optometrists registered with the General Optical Council.
• Doctors currently registered with General Medical Council.
• Dentists currently registered with General Dental Council.

The following professionals (who are in the main non-registered) are permitted to administer under the protocol with appropriate supervision as set out below, subject to the requirements set out below:

• Healthcare support workers.
• Pharmacy technicians, provisionally registered pharmacists, pre-registration pharmacists and other pharmacy support practitioners.
• Retired clinical practitioners such as doctors, dentists, pharmacists, nurses, optometrists, chiropodists/podiatrists, dieticians, occupational therapists, orthoptists, orthotists/prosthetists, paramedics, pharmacy technicians, physiotherapists, radiographers, speech and language therapists, dental hygienists and dental therapists not currently registered.
• Student doctors, dentists, pharmacists, nurses, midwives, optometrists, chiropodists/podiatrists, dieticians, occupational therapists, orthoptists, orthotists/prosthetists, paramedics, physiotherapists, radiographers, speech and language therapists, dental hygienists and dental therapists not currently registered.
• Healthcare Scientists.
• Dental nurses.
• Physician's assistants.

The following non-registered Armed Forces staff are permitted to administer under the protocol with appropriate supervision as set out below, subject to the requirements set out below:

• Combat Medical Technician – Class 1,2 &3 (CMT)
• Royal Navy Medical Assistant (RN MA)
• Royal Air Forces Medic
• Defence Medic
• Healthcare Assistant (HCA)
• Military General Duties Vaccinators

Requirements

All those working under this protocol must have undertaken training, be assessed as competent and receive supervision appropriate to the stage of activity they are undertaking. Where multiple person models are used, the provider must ensure that all elements of the protocol are complied with in the provision of vaccination to each individual. The provider is responsible for ensuring that persons are trained and competent to safely deliver the activity they are employed to provide under this protocol. As a minimum, competence requirements stipulated in the protocol must be adhered to.

All persons must be designated by name by the provider as an approved person under the current terms of this protocol before working to it, and listed on the practitioner authorisation sheet in Annex B. All staff listed on the sheet will be covered by NHS indemnity extended by the Health Board who is responsible for the COVID-19 vaccination programme in that locality. Protocols do not remove inherent obligations or accountability. All practitioners operating under this protocol must work within their terms of employment at all times; registered healthcare professionals should also abide by their professional code of conduct.

There are three underpinning principles to which every person undertaking activities under the remit of this protocol must adhere

1. Training

• They must have undertaken training appropriate to this protocol and relevant to their role, as required by local policy and health board standard operating procedures and in line with the training recommendations for COVID-19 vaccinators.
• They must have met the requirements set out in the NES Proficiency document - COVID-19 vaccine administration for registered staff or the NES Proficiency document – COVID-19 vaccine administration- Healthcare support workers

2. Competency

• Those providing clinical supervision to those administering the vaccine must be competent to assess individuals for suitability for vaccination, identify any contraindications or precautions, discuss issues related to vaccination and obtain informed consent from the individuals being vaccinated.
• The issue of consent when offering vaccination to children and young people is complex. In Scotland, the legal age of capacity is 16. However, children under the age of 16 can consent to medical treatment if they understand what is being proposed. Capacity should be assessed in line with current established practice, with persons undertaking activities under the remit of this protocol seeking advice from their Immunisation Co-ordinator as required.
• All persons must either be an appropriate prescriber or one of above noted registered professionals. Those that are not registered professionals, and those returning to immunisation after a prolonged interval (more than 12 months), should be assessed and signed off as meeting the requirements of the relevant NES Proficiency document - COVID-19 vaccine administration. They should be observed administering the vaccine until both they, and their supervisor or trainer, feel confident that they have the necessary knowledge and skills to administer vaccines safely and competently.
• Experienced vaccinators should use the relevant NES Proficiency document to self-assess that they are able to meet all the competencies listed and confirm that they have the knowledge and skills necessary to administer COVID-19 vaccine.
• They must have completed local IPC training and comply with the vaccination guidance with the National COVID-19 IPC guidelines available: National Infection Prevention and Control Manual: Scottish COVID-19 Infection Prevention and Control Addendum for Acute Settings

In addition, and where indicated as relevant to the role:

• They must be familiar with the vaccine product and alert to any changes in the manufacturers summary of product characteristics (SPC) and familiar with the national recommendations for the use of this vaccine.
• They must be familiar with, and alert to changes in relevant chapters of Immunisation Against Infectious Disease: COVID-19: the green book, chapter 14a.
• They must be familiar with, and alert to changes in the relevant provider's standard operating procedures (SOPs) and provider's arrangements for the national COVID-19 vaccination programme.
• They must be competent in the correct handling and storage of vaccines and management of the cold chain if receiving, responsible for, or handling the vaccine.
• They must be competent in the recognition and management of anaphylaxis, have completed basic life support training and be able to respond appropriately to immediate adverse reactions.
• They must have access to the provider's protocols and relevant COVID-19 vaccination programme online resources.
• They must be competent in intramuscular injection technique if they are administering the vaccine, this should include a practical element.
• For those preparing the vaccine, they must be competent in the handling of the vaccine product, procedure for dilution of the vaccine and use of the correct technique for drawing up the correct dose.
• For those in record keeping roles, they must understand the importance of making sure vaccine information is recorded on the vaccination management app.
• They should fulfil any additional requirements defined by local policies developed in accordance with any national guidance.

3. Supervision

• A period of supervised practice to allow observation of, and development of skills in vaccine administration and application of knowledge to practice is essential. Supervision for new immunisers and support for all immunisers is critical to the safe and successful delivery of the COVID-19 immunisation programme.
• Non-registered professionals and non-registered Armed Forces staff must be supervised and supported by a registered healthcare professional at all times.
• The clinical supervisor must be a registered healthcare professional trained and competent in all aspects of the protocol and provide clinical supervision for the overall provision of clinical care provided under the protocol.