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Monitoring questions for hospital-led COVID-19 vaccination services

Categories:
  • Organisations we regulate,
  • Hospitals

These questions apply to hospitals-led providers responsible for administering the COVID-19 vaccine in vaccination centres.

During the monitoring call our inspector will focus on these specific key lines of enquiry. You can open the questions to see the type of detail they will be interested in.

Safe

S1: How do systems, processes and practices keep people safe and safeguarded from abuse?

Safeguarding

  • How do you ensure staff recognise safeguarding issues for adults, children and other vulnerable people, and that they take appropriate action?

Infection prevention and control

  • Are infection risks to people using the service being thoroughly assessed and managed?
  • Do you have the resources to obtain, and reliable access to, all the supplies and PPE you need, for both staff and, where necessary, people who use your service?

Clinical waste

  • What is the process to safely and securely manage clinical waste at the site?
  • Is clinical waste managed safely at the point of administration?
S2: How are risks to people assessed, and their safety monitored and managed, so they are supported to stay safe?
  • Is there access to emergency medicines on site and how are these checked?
  • What access is there to emergency medical support on site in the event of an adverse reaction?
S3: Do staff have all the information they need to deliver safe care and treatment to people?

Patient records

  • Are records of administration made in line with government guidance?
S4: How do you ensure the proper and safe use of medicines, where your service is responsible?

Vaccine receipt and storage

All providers:

  • How are records kept of the vaccine received?
  • How is the cold chain maintained?
  • Are vaccines delivered direct from the supplier or transferred internally?
  • Are there suitable security arrangements to prevent theft?

Providers administering mRNA vaccines:

  • What records are kept when a vaccine is moved from ultra low temperature (ULT) to fridge temperature? How do you allow time to ensure vaccines thaw properly?
  • What records are kept to ensure correct storage conditions and how is stock managed, monitored and maintained?
  • What are the contingency arrangements in place in case of failure of cold storage?

Providers administering viral vector vaccines:

  • What records are kept to ensure correct storage conditions are monitored and maintained?
  • Is there a process to monitor expiry dates?
  • What are the contingency arrangements in place in case of failure of cold storage?

Vaccine administration and delivery

Supply chain

  • How is the cold chain monitored and maintained during transport and from satellite locations?
  • How are decisions made on the level of stock that needs to be held to meet the needs of patients coming to the service?

Vaccine administration

  • Are there suitable facilities to prepare doses of the vaccine and how are these monitored and maintained?
  • Is the vaccine administered in a place that maintains a patient’s privacy and dignity? Is it suitable for people with access or other needs?
  • Are you ensuring staff at satellite sites are working to relevant Patient Specific Directions (PSDs), Patient Group Directions (PGDs) or National Vaccination protocols when preparing and/or administering a vaccine?
  • What information about the vaccine do you provide to patients at the vaccination site, and how are staff supported to respond to questions from people who may be reluctant to be vaccinated?

Standard operating procedures and governance

  • Are there standard operating procedures (SOPs) or policies in place to cover all aspects of vaccine administration and storage at the satellite location?
  • Are there clear records of temperature monitoring from receipt through to administration?
  • Are there clear stock control records from receipt through to administration?
S6: Are lessons learned and improvements made when things go wrong?

Managing vaccine drug alerts/recalls

  • What is the process to manage drug alerts and recalls? What systems are in place to cascade relevant information to staff?
  • Are you registered with the MHRA Central Alerting System so you receive alerts that may be relevant to the vaccine? What system is in place to make sure you take effective timely action in respect of relevant alerts?

Effective

E3: How does the service make sure that staff have the skills, knowledge and experience to deliver effective care, support and treatment?

Staff training and supervision

  • How have staff been trained to administer the vaccine? Are there records of this?
  • How have staff been deployed to assist in other roles been trained? Are there records of this?

Volunteer training and supervision

  • How have volunteers been trained for their roles? Are there records of this?
E6: Is consent to care and treatment always sought in line with legislation and guidance?

Consent

  • How is consent obtained and recorded at the site and what information governance safeguards are in place to protect people's data?

Capacity to consent

  • How do you ensure that staff and volunteers apply relevant legislation where people may lack the capacity to consent?

Responsive

R3: Can people access care and treatment in a timely way?

Managing high risk/vulnerable patients

  • How do you ensure high-risk/vulnerable patients and pathways in non-vaccination services are identified and prioritised appropriately?

Management of backlogs and waiting times

  • How are you working with partners to maintain and improve access to non-vaccination services?

Well-led

W4: Are there clear responsibilities, roles and systems of accountability to support good governance and management?

Senior staff accountability

  • Is there a designated person who has clinical oversight of the staff at the location?
  • How does the person responsible maintain oversight of the vaccine’s storage and use?
Last updated:
28 January 2021