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Purpose       

This document describes the procedure for monitoring an ultra-cold temperature freezer storing COVID-19 Pfizer (COMIRNATY™) vaccines.

Scope

The monitoring of ultra-cold temperature freezers containing COVID-19 Pfizer (COMIRNATY™) vaccine.

Responsibility

All workers involved in the handling, preparation and administration of the COVID-19 Pfizer (COMIRNATY™) vaccine must have undertaken the specified training modules in the management of vaccines requiring storage at ultra-cold temperatures. Staff must have access to and use appropriate personal protective equipment (PPE), this includes gauntlets, gloves, aprons and goggles/face mask. In addition to the PPE provided, staff must ensure they wear clothing that covers their legs and arms, and shoes must be completely enclosed. All staff must be aware of the requirements outlined in this document.

Background

About this document

This document provides guidance on procedures for the storage and monitoring requirements of vaccines at ultra-cold temperatures. This document aims to:

  • Ensure consistent and effective vaccine storage, monitoring and reporting processes in all public health facilities
  • Facilitate the administration of viable vaccines to vaccine recipients
  • Ensure vaccine cold chain breaches are identified and managed consistently, efficiently and effectively
  • Reduce vaccine wastage as a result of vaccine cold chain breaches, and
  • Inform providers of requirements for ordering, storing and monitoring vaccines.

This guidance document must be read in conjunction with specific vaccine information.

Requirements

All vaccines must be stored in a freezer which has been assessed as being appropriate for the storage of the COVID-19 Pfizer (COMIRNATY™) vaccines. The freezer must be plugged into an uninterrupted power supply and must be continually data logged with back to base alarm to individual/s that are available to respond immediately 24 hours a day. The data logging report must be downloaded and reviewed at least weekly. The freezer must also have an audible alarm

The freezer's current/minimum/maximum temperatures must be visualised and manually recorded four times a day, twice in the morning and twice in the afternoon/evening, including at the beginning and end of the shift (in addition to recording each time the freezer is accessed). These temperatures must be recorded on the NSW Health Freezer Temperature Chart (NH700657). A staff member must be allocated for each shift to undertake this duty.

Local procedures must be in place to respond to cold chain breaches and power failures, including reporting temperatures outside -60°C to -90°C range immediately to senior executive and also to the State Health Emergency Operations Centre (SHEOC) on 9859 5690.

Vaccines must not be discarded until advice is received from the SHEOC.

Cold chain breaches resulting in vaccine wastage or recall and revaccination of patients must be reported in the NSW Health Incident Information Management System (IIMS) to facilitate investigation, resolution and minimise the risk of future incidents.

All staff involved in the handling, preparation and administration of the COVID-19 Pfizer (COMIRNATY™) vaccine must be appropriately trained (undertake the Australian Government COVID-19 training program and the Health Education and Training module in Vaccine Storage and Cold chain management (also available via NSW Health - Immunisation programs).

Equipment

Effective storage of vaccines in ultra-cold temperatures requires:

  • A freezer which has been assessed as appropriate for the storage of vaccines at ultra-cold temperatures, this includes evidence that the freezer has been serviced in the last 12 months
  • A temperature display, with min/max/current
  • Back to base alarm and automated temperature monitoring systems that have been serviced according to the manufacturers recommendations
  • A portable data logger battery
  • Appropriate Personal Protective Equipment (PPE), which includes gauntlets, goggles, apron and goggles/face mask.

Local procedures must include an equipment maintenance log or similar process to document maintenance of cold chain equipment. The document must be readily accessible to staff to assist in the investigation of cold chain incidents.

Freezer monitoring

At a minimum, the freezer's current, minimum and maximum temperatures must be visualised and manually recorded on the NSW Health Freezer Temperature Chart four times a day. This should be performed twice in the morning and twice in the afternoon/evening, including at the beginning and end of the shift (in addition to recording temperatures following each time the fridge is accessed). The temperature readings must be recorded from the visual temperature display on the freezer.

Staff should visualise the temperature display prior to storing a new delivery of vaccines or transferring vaccines to refrigeration for thawing to ensure there have been no temperature excursions.

Four daily manual temperature checks are required regardless of whether continuous data logging, back to base alarm systems or automated temperature monitoring systems are in use. This is to ensure frontline staff are familiar with the normal functioning of the freezer, can identify the early warning signs of potential freezer malfunction and ensure vaccines have not been subjected to a cold chain breach prior to administration.

Where a facility is not operational 24 hours/day for seven days/week, the freezer's current/minimum/maximum temperature must be checked on the first operational day (since the last recording) and four times a day thereafter. The automated temperature monitoring system or data logging report is to also be downloaded and/or reviewed before any vaccines are removed for administration.

Reset the minimum/maximum thermometer after each reading, following any excursion outside -60°C to -90°C and on receipt of a new vaccine delivery. Ensure the freezer has returned to within -60°C to -90°C before resetting. If the freezer temperature reaches greater than -60°C immediate action is required (see Section 8 Management of freezer cold chain breaches).

Continuously measure the vaccine freezer temperature using a permanent data logger, back to base monitoring system or automated temperature monitoring system.

The data logging/back to base monitoring report must be downloaded and reviewed by the delegate weekly and following any identified cold chain breach.

Each facility must have a local procedure for downloading and reviewing the data logging reports or monitoring and responding immediately to alerts from the automated temperature monitoring system.

All staff responsible for cold chain management must have access to and know how to download and review the data logging reports (stored centrally in an appropriately named folder for each freezer and date), including back to base monitoring and automated temperature monitoring system reports as appropriate.

The NSW Health Freezer Temperature Chart (NH700657) must be checked and signed off at the end of each week before storing centrally.

Record any cold chain breaches on the NSW Health Freezer Temperature Chart (NH700657).

Management of freezer cold chain breaches

A 'cold chain breach' has occurred if the freezer's temperature has been outside the recommended range of -60°C to -90°C. Corrective action must be taken immediately.

Once a cold chain breach has been identified, the following procedures must be followed:

  • Ensure the freezer door is closed, the freezer is plugged in at the power point and turned on. Contact the engineer immediately if broken.
  • Vaccines that have been identified has having an ultra-cold chain breach must be quarantined at 20C-80C in a fridge and labelled "QUARANTINED STOCK - DO NOT USE"
  • Label the affected freezer 'DO NOT USE' (if applicable)
  • Inform the executive level delegate for immediate action.
  • Download and review the data logging report to determine breach temperature and duration.
  • Where vaccines are involved in the breach contact SHEOC on 9859 5690 immediately. The SHEOC will require the cold chain breach details data logging and corresponding four daily temperature readings to assess the breach.
  • Vaccines must not be discarded until advice has been provided by the SHEOC. If vaccines are required to be discarded, report the exact number of vaccine vials wasted to the SHEOC using the Pfizer Vaccine Wastage Report. Expired vaccines must also be reported to the SHEOC in the same manner.
  • Determine if anyone has received the compromised vaccine. Discuss revaccination requirements with the SHEOC.
  • Record freezer temperature issues and actions on the NSW Health Freezer Temperature monitoring chart.
  • Report the incident on IIMS

Attachments

Freezer temperature monitoring chart

Current as at: Friday 19 February 2021
Contact page owner: Health Protection NSW