Document Version Control

Revision History

Version Date Section/ Appendix Summary of Changes

14.0 17/06/2021

15.0 01/07/2021

3 Changed “If an individual has an adverse event” to “Reporting an adverse event” 4 Removed mask purchasing from DHBs & Providers and added PPE purchasing to Ministry of health 5.5 Removed information on mask wearing during vaccination. However, additional IPC precautions may be necessary in the context of the COVID-19 pandemic (e.g. PPE usage in line with the current Alert Level) 5.17 Updated the form name to “New Facility/ Site Set Up Form (v13.0)” 6.2 Changed “recovery room” to “observation area” 6.3 Table 1 “After the Event” column • Removed information about contacting household members. • Changed “Registered/Practice Nurse” to “Registered Health Professional”. • Changed “support person with bystander CPR/ first aid training” to “support person with CPR training” Table 2 • Removed “imms event” for clarity 8.1.2 Changed “at” to “from” clarifying that the booking of the second dose appointments can be made at any time given the appointment is 21 days after the first dose Removed information to call IMAC when booking second dose appointments 8.2 Additional information around foreign bodies and discolouration of the vaccine and information about labelling vials after vaccine dilution 8.2.1 Added note when drawing up less than 6 doses 9.2.3 Changed delivery of vaccines from daily to weekly 9.2.4 Changed “request consumables” to “order consumables” 9.2.6 Updated information on PPE ordering for current and new providers 9.4 Updated information on step “Site contact conducts visual check” around broken vials and waste 9.9 Updated stock take information from weekly to daily Additional information to report stock consumption and waste 10 New section covering CIR Inventory Portal 2 Additional abbreviations added 7 New section ‘Vaccinating Border or MIQF Workers’ 9.3 & 9.3.1 Additional recommended vaccination screening questions

9.4.3 Additional step to check the label and confirm expiry time after dilution added (Check vaccine step) Removed expiry date recording instruction under ‘Record vaccination information in CIR’

11 Updated the URL’s, SOP Inventory Management PDF and SOP Order Fulfilment PDF 12 New section about the National Immunisation Booking System (NIBS) Appendix B Added Appendix B: New Facility/Site Setup Form v1.3 5.5.3, 9.3 & 9.4.3 Additional information to prevent underage vaccinations and early second vaccination doses.

16.0 15/07/2021 5.7 New Serious Adverse Event and incident process and documents (Appendices E, F, G)

5.18 New Facility & Site Closure information and form (Appendix C) 9.1 Updated information on the National Immunisation Booking System

17.0 29/07/2021

18.0 12/08/2021 9.1.2 Clarified information around the timing of second doses 9.2 Under labelling of syringes changed: Date and Time “after” to “of” dilution

9.2.1 Updated Note to include more than 7 doses per vial 9.4.1 Additional supported decision-making information and process (Appendix D) 9.5 Examples of known vaccine errors added 10 Updated Logistics & Inventory Management section 10.13 New Logistics Cheat Sheet added 12.3 Booking System Roles removed Appendix B Updated version of the site set up form (v1.4) Appendix C New Facility & Site Closure Form Appendix D New Supported Decision-Making Process

Appendix E New Incident Process Steps which outlines the process steps for notification of serious incidents to the programme

Appendix F New COVID-19 vaccine related Severity Assessment Code Examples Appendix G New Form to notify the programme of incidents and serious adverse events 5.1.3 Supported decision-making is available on IMAC’s website 5.6 & 9.7.2 Updated time period for sites to contact Interwaste regarding their site set up. Updated wording to clarify that sites arrange vial disposal services through Interwaste. 9.4.5.1 New sub-heading ‘Recording an anaphylaxis event’ and the use of the Anaphylaxis Checklist (found on IMAC’s website) 9.4.7 New ‘Active Monitoring’ section 10.4.6 Updated process for ordering other consumables through the CIR Portal. 10.6 Updated ‘Site contact conducts visual check’ step. The site contact will open the Credo Cube/Woolchill box and the internal vaccine packaging and conduct a visual check of the outer packaging. Visual checks of the vials in each package is no longer needed.

9.1.2 & 9.4.3 Updated information around the standard interval (six weeks) between vaccine doses.

9.4.2.1 New section: Missing or Incorrect Information Loaded into CIR 9.4.7 ‘Active monitoring’ has a new name: Post Vaccine Symptom Check

10.4.5 Updated consumables kits section Following tables updated: • Calculations of consumables • Itemisation of consumable kits • Order as required Sizes and weights of kits

11.3.7 New section: Quality Assurance Approval Step of Orders