- Legislative mechanisms
- Service summary
- Assurance framework
- Action plan template
- References and links to further information
Publication approvals reference: C1141
Version 1, 4 March 2021
The purpose of this framework is to provide organisations delivering COVID-19 vaccine services with a quality assurance tool aligned to the operating frameworks and standard operating procedures underpinning the delivery models for these settings: Hospital Hubs, Local Vaccination Services (LVS) and Vaccination Centres (VC).
The tool can be used to ensure services have ongoing robust assurance in place, to demonstrate compliance with the legal frameworks for COVID-19 vaccine delivery and to ensure the standards expected for a healthcare setting are met. It will also help identify any areas of risk and show the corrective actions taken in response. The tool can be used as a self-assessment or by those responsible for reviewing the quality of healthcare in the locality. The tool can provide assurance to trust and PCN boards that organisational compliance has been systematically reviewed.
This framework is not mandated. If organisations don’t use it, they should ensure they have equivalent mechanisms to evidence assurance. It is recommended that the assurance framework is used to establish the monitoring needed for day-to-day oversight as new services are developed, then completed within 8 weeks of opening (or as soon as possible if the service has been operational for longer than 8 weeks). The tool should also inform future service development including up-scaling of existing services.
The framework is aligned to the Care Quality Commission framework for ease of use alongside other quality assurance processes.
The 2012 Human Medicines Regulations set out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.
They also provide for enforcement powers for the authorisation and supervision or administration of medicinal products for human use.
All medicines are classified according to three legal categories which are: Prescription only Medicines, Pharmacy Medicines and General Sales List Medicines.
All vaccines are classed as prescription only medicines which means that they can only be supplied on the authority of a prescriber (doctor or other independent prescriber).
The regulations do not permit nurses, or other registered healthcare professionals (HCPs), who are not qualified prescribers to administer or supply prescription only medicines (POMs) unless one of four types of instruction is in place:
- Signed prescription
- Patient Specific Direction (PSD)
- Patient Group Direction (PGD)
- National Protocol (for influenza or COVID-19 vaccines only)
The vaccination service must operate under one of the above types of instruction.
(See Word document for template)
|Site name||Region||Vaccination service type (Model)||Type(s) of instruction in place for vaccine administration.|
Provide a narrative describing the service including location, the vaccines being administered, and for VCs, the number of PODs in operation:
Date of completion:
(See Word document for template)
|Key line of enquiry||Suggested evidence||Gaps in assurance||Mitigating actions|
Clients using the vaccination service are protected from abuse and avoidable harm.
|There is evidence of learning from incidents and a transparent reporting culture:
Process for referring to the Clinical Advice and Response
|The deployment, governance, handling, and preparation of vaccines is in accordance with the Specialist Pharmacy Service Technical Standard Operating Procedures (SOPs) for COVID- 19 Vaccines||Approved SOPS pre vaccine in operation.
To include procedure for roving vaccinators in PCNs (primary care networks).
|Cold chain monitoring is in place and breaches identified in a timely manner||
|Delivery of the vaccine is checked, accepted, and recorded by a registered healthcare professional and cold chain maintained.||SOP|
|There is a process in place to oversee and manage safe access and queuing – with scope to adapt in anticipation of each new cohort||
|National guidance and resources for COVID-19: infection prevention and control (IPC) is adhered to and overseen.||
|There is an approved process to manage clinical waste from the point of usage to disposal/collection to ensure the health and safety of staff, volunteers and clients.||
|Staff and volunteers are tested using Lateral Flow point of care testing. The plan is overseen and meets the Lateral Flow national protocol of twice-weekly testing||T&T compliance data.|
|There is evidence that the environment is assessed as safe; in line with COVID secure guidance by the HSE (Health and Safety Executive) There is good ventilation throughout the service||Environmental checklist and assurance certificate by H&S/Estates Lead.|
|Provision for the management of adverse reactions is in line with guidance with the Green Book Ch14a, recommendations for medicines and equipment by the Resuscitation Council UK, are risk assessed and monitored.||
|Attendees are safeguarded against abuse and neglect. Staff comply with provider safeguarding policies (adults and children). Safeguarding concerns attributed to the vaccination service are reported and monitored||
|There is a process to review staff rosters to ensure staffing and the supervision of delegated practice is in accordance with the legal framework in place||Staffing data:
|Clinical records are maintained according to policy.
Personal identifiable data (PID) is managed in accordance with provider approved information governance process
|Risks are managed, reviewed and kept up to date||Risk register|
|All staff including volunteers have undergone appropriate recruitment checks prior to appointment.||Employment checks|
|Procedures are in place to handle multiple vaccines safely including staff awareness and training, IT, storage, and separation in ‘time and space’||
|There is a process in place to ensure equipment is used and tested as per manufactures guidance and fit for purpose||Equipment audit|
The vaccination service successfully achieves intended outcomes. Service provision is evidence based.
|Available capacity is in line with the site target max throughput per day. Alternatively, operational ramp up plans are in place to resolve the use of capacity.||
|The consenting processes is in line with the legal framework as detailed in the Green Book, overseen in practice by a suitably skilled practitioner. The support provided is in line with the Mental Capacity Act and Equality Acts to including the provision of reasonable adjustments and documentation of best interest decisions.||
|There is sufficient oversight and monitoring to prevent vaccine wastage.||
|Public health messaging following vaccination is available, up to date and regularly reviewed in line with national PHE (Public Health England) policy and guidance (PHE ‘What to Expect’ Leaflet)||Information inventory|
|Workforce models are agile and flexible to enable increase in throughput as supplies increase||Plan for scale up including consideration of non-registered and registered workforce.|
|Staff overseeing and delivering vaccines are appropriately trained and competent and up to date with current vaccines.||Policy.
Education audit including training and competency sign off compliance.
Clients are treated equitably with care, compassion dignity and respect.
|Service user experience is captured and informs service and quality improvement||Service user feedback. Service user engagement.|
|Complaints and compliments are responded to in accordance with policy. Themes inform ongoing quality improvement.||Policy.
|Patient advocate or support roles (for example from St John Ambulance in Vaccination Centres) are in place to support attendees and to support with navigation and throughput.||Workforce model.
The vaccination service is organised to meet the needs of the designated population.
|Information for attendees is regularly reviewed and updated according to information standards.||Policy.
|The services are responsive to meet the needs of diverse and seldom heard populations.
||Policy in place. Demographic data. Service user feedback. Equality Impact assessments Disability access provisions|
There is evidence of effective leadership and robust governance processes in place to oversee activity within the vaccination service.
|There is a clinical lead responsible for the delivery of all aspects of vaccination service||Service specification|
|Clinical governance and supervision processes are in place and signed off by the Vaccination Site Clinical Lead||Approved SOP|
|There is Pharmacist oversight into the vaccination process.||Named person available for day-to-day vaccine queries|
|Statutory and Mandatory Training records demonstrate compliance with local policy||Training data|
|There are policies and
procedures in place to oversee the experience and wellbeing of staff including the safe provision of adequate staff rest areas
Staff survey results.Roster review (break allocation).
COVID-19: Secure assessment of Staff break areas.
|There is an agreed process to facilitate ongoing quality improvement.||QI plan.
|Staff Indemnity has been considered through honorary contracts or service level agreements where not directly employed (including volunteers where vaccinating)||Lead employer agreement for staff.|
|There are business continuity plans applicable to the site in the event of a major incident.
(These are examples only not exhaustive)
|BCPs. Local Health Resilience Forums Cold chain management policy Including out of hours.|
(See Word document for template)
|Overall summary of assurance
Select as applicable:
|The evidence provides:
Substantial assurance: The service demonstrates robust processes for ongoing assurance across all domains and evidence is consistent with good practice.
Full assurance: The service demonstrates robust processes for ongoing assurance across all domains. Further evidence is required to demonstrate good practice
Limited assurance: The service is developing robust processes for ongoing assurance across all domains.
Concerns highlighted: Improvements required and a repeat assurance review in
[insert due date]
(See Word document for template)
|Issue||Mitigating action||Lead||By when||Status||Comments|
Anaphylaxis guidance for vaccination settings: https://www.resus.org.uk/about-us/news-and-events/rcuk-publishes-anaphylaxis-guidance-vaccination-settings
Asymptomatic staff testing for COVID-19: Coronavirus » Asymptomatic staff testing for COVID-19 (england.nhs.uk)
Care Quality Commission: Monitoring questions for hospital-led COVID-19 vaccination services: https://www.cqc.org.uk/guidance-providers/how-we-inspect-regulate/monitoring-questions-hospital-led-covid-19-vaccination#accordion-4
COVID-19 vaccinator competency assessment:
Green Book, Chapter 14a – COVID-19 – SARS-CoV-2. 12 February 2021: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach ment data/file/955548/Greenbook chapter 14a v6.pdf
Health and Safety Executive: Making your workplace COVID-secure during the coronavirus pandemic (hse.gov.uk)
2012 Human Medicines Regulations: https://www.legislation.gov.uk/uksi/2012/1916/contents/made
Legal mechanisms for administration of the COVID-19 Vaccine(s): C0923-legal-mechanisms-for-adminstration-of-the-covid-19-vaccines-v2-10-december-2020.pdf (england.nhs.uk)
National guidance and resources for COVID-19: infection prevention and control (IPC): https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control
Public Health England information leaflet ‘What to expect after vaccination’: https://www.gov.uk/government/publications/covid-19-vaccination-what-to-expect-after-vaccination
Public Health England Coronavirus (COVID-19) Resource Centre: https://coronavirusresources.phe.gov.uk/
Specialist Pharmacy Service Technical Standard Operating Procedures (SOPs): https://www.sps.nhs.uk/home/publications/standard-operating-procedures/
Standard operating procedure Management of COVID-19 vaccination clinical incidents and enquiries: https://www.england.nhs.uk/coronavirus/publication/standard-operating-procedure-management-of-covid-19-vaccination-clinical-incidents-and-enquiries/