Information

Coronavirus (COVID-19) AstraZeneca vaccine (ChAdOx1-S [Recombinant]): national protocol v3.1

This protocol is for the supply and administration of AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) to individuals in accordance with the national COVID-19 vaccination programme. This protocol only allows supply and administration during or in anticipation of the COVID-19 pandemic.

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AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant])Vaccine National Protocol

Reference no: AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) Vaccine Protocol

Version no: v 3.1

Valid from: 02 February 2021

Review date: 30 November 2021

Expiry date: 31 December 2021

1. About the National Protocol

This protocol is for the supply and administration of AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) to individuals in accordance with the national COVID-19 vaccination programme. This protocol only allows supply and administration during or in anticipation of the COVID-19 pandemic where the disease represents a serious risk or potentially serious risk to human health.

This protocol is for the supply and administration of AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) by appropriately trained persons in accordance with regulation 247A of the Human Medicines Regulation 2012, as inserted by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020

The Scottish Government has developed this protocol which has been approved by the Scottish Ministers to facilitate the delivery of the national COVID-19 vaccination programme by Health Boards in Scotland and any organisation a Health Board makes arrangements with to deliver such services on its behalf, referred to as “the provider”. Please note that in the context of this protocol, “the provider” means:

(a) a Health Board,

(b) a Health Board working with Armed Forces staff where Armed Forces staff are working in Health Board settings, or

(c) an organisation delivering services on behalf of a Health Board.

This protocol may be followed wholly from patient assessment through to post-vaccination by a single person. Alternatively, obtaining consent and patient assessment may be undertaken by a registered healthcare professional with the process of administration undertaken by a non-registered professional or a non-registered Armed Forces staff member under clinical supervision.

Where multiple person models are used the provider must ensure that all elements of the protocol are complied with in the provision of the vaccination to each patient.

The provider is responsible for ensuring that persons are trained and competent to safely deliver the activity they are authorised to provide under this protocol. As a minimum, competence requirements stipulated in the protocol under ‘Characteristics of staff’ must be adhered to.

The provider must identify a clinical supervisor who has overall responsibility for provision of vaccinations under the protocol at all times. This includes overall responsibility for the activities of any Armed Forces staff working under the protocol.

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.

The clinical supervisor must be identifiable to service users. Whenever the protocol is used, the name of the clinical supervisor taking responsibility and all of the people working under different activity stages of the protocol must be recorded for the session using the schedule in Annex C or maintaining an equivalent electronic record. The clinical supervisor has ultimate responsibility for safe care being provided under the terms of the protocol. Persons working under the protocol may be supported by additional registered healthcare professionals, but the clinical supervisor retains responsibility.

Persons working to the protocol must understand who the clinical supervisor for their practice is at any time and can only work under their authority. The clinical supervisor may withdraw this authority for all persons or individual persons at any time and has authority to stop and start service provision under the protocol as necessary. All members of staff have a responsibility to, and should, report immediately to the clinical supervisor any concerns they have about working under the protocol in general or about a specific individual, process, issue or event.

Individual practitioners must be designated by name to work to this protocol. Individuals working in accordance with this protocol must ensure they meet the staff characteristics for the activity they are undertaking, make a declaration of competence and be authorised in writing by the provider. This can be done by completing Annex B of this protocol or maintaining an equivalent electronic record.

It is a Health Board’s responsibility to adhere to this protocol. Where the Health Board is not the provider, it is the Health Board’s responsibility to ensure that the provider adheres to this protocol. The final authorised copy of this protocol should be kept, by Health Boards for 8 years after the protocol expires. Providers adopting authorised versions of this protocol should also retain copies, along with the details of those authorised to work under it, for 8 years after the protocol expires.

Providers must check that they are using the current version of this protocol. Amendments may become necessary prior to the published expiry date. Current versions of protocols authorised by the Scottish Ministers in accordance with regulation 247A of the Human Medicines Regulations 2012 can be found on the Scottish Government website: (tbc)

2. Approval and Clinical Authorisation

This protocol is not legally valid, in accordance with regulation 247A of Human Medicines Regulation 2012, as inserted by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020, until approved by the Scottish Ministers.

On 2 February 2021 the Scottish Ministers, approved this protocol in accordance with regulation 247A of Human Medicines Regulation 2012. Approval of clinical information in Annex A is via the Scottish Government Chief Medical Officer, Chief Pharmaceutical Officer and Chief Nursing Officer for the delivery of the national COVID-19 vaccination programme, with defined limitations to authorisation that may be updated from time to time as may be required.

Authorised for use by the following organisations and/or services

All Health Boards in Scotland, and organisations Health Boards make arrangements with to deliver services on their behalf.

Limitations to authorisation

This authorisation applies to the supply and administration of the vaccine(s) only under the conditions set out in the authorisation for supply or license set out by the Medicines and Healthcare products Regulatory Agency.

Clinical authorisation
Role Name Sign Date
CMO Gregor Smith 3rd June 2021
CNO Amanda Croft 3rd June 2021
CPO Alison Strath 3rd June 2021

It is Health Boards’ responsibility to ensure they and any organisations they make arrangements with to deliver services on their behalf operate the specified vaccination services in accordance with the protocol. Any provider administering AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) vaccine under protocol must work strictly within the terms of this protocol.

The national COVID-19 vaccination programme may also be provided under patient group direction, under written instruction for supply and administration in the course of an occupational health scheme, or on a patient specific basis, by or on the directions of an appropriate prescriber. Supply and administration in these instances are not related to this protocol.

3. Change history

Version number Change details Date
V01.00 New protocol for AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) vaccine. 21 January 2021
V02.00 Updated protocol to reflect Armed Services staff roles 02 February 2021
V02.1 Clinical annex updated 22 February 2021
V02.2 Clinical annex updated 20 April 2021
V02.3 Clinical annex updated 10 May 2021
V02.4 Clinical annex updated 24 May 2021
v.03.00 Updated protocol to add Military General Duties Vaccinators 02 June 2021
v.03.1 Clinical annex updated 05 July 2021

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 https://learn.nes.nhs.scot/37676/immunisation/covid-19-vaccines

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 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

a. 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

b. Competency

  • Those providing clinical supervision to those administering the vaccine must be competent to assess individuals for suitability for vaccination, identify any contraindications/exclusions or precautions, discuss issues related to vaccination and obtain informed consent from the individuals being vaccinated.
  • 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), should it become licensed, or the Regulation 174 Information for UK Healthcare Professionals 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: the Green Book COVID-19: the green book, chapter 14a - GOV.UK (www.gov.uk).
  • 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 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.

c. 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.

5. Clinical condition or situation to which this Protocol applies

AstraZeneca COVID-19 Vaccine (ChAdOx1-S [Recombinant]) is indicated for active immunisation against COVID-19 disease caused by SARS-CoV-2 virus in accordance with Scottish Government COVID-19 immunisation programme and recommendations given in Chapter 14a of the Immunisation Against Infectious Disease: the ‘Green Book’ COVID-19: the green book, chapter 14a - GOV.UK (www.gov.uk) and Scottish Government CMO letters relating to COVID-19 vaccination.

Contact

Email: vaccineoperationaloversight@gov.scot

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