New Zealand Vaccine Storage Regulations

New Zealand vaccine storage regulations and guidelines. How to comply with New Zealand vaccine storage requirements. Proper storing and handling of vaccines is very important in the medical sector.

Each country has specific regulations that must be adhered to, although most of the vaccine handling rules apply internationally.

In this article we will focus on the New Zealand regulations for vaccines, but won’t go into details of the universal rules, as we have mostly covered them in a previous article for Canada.

The regulations we will cover are based on the National Standards for Vaccine Storage and Transportation for Immunization Providers 2017 documentation.

The Cold Chain

The “cold chain” means the process of maintaining the optimal conditions for vaccines during the transport, storage, and handling – starting at the medicine manufacturer and finally ending with the administration of the vaccine to the client.

Because any excessive heat or cold exposure can damage the vaccines or would result in their reduced effectiveness, the optimum temperature for refrigeration must need to be maintained between +2°C and +8°C (+35°F and +46°F).

The frozen vaccines should be stored at an optimum temperature of –15°C (+5°F) or lower.

Some vaccines also require protection from light (sunlight, UV or fluorescent light).

The proper storage temperatures must be maintained at every link in the chain, otherwise the vaccine may be damaged and become unsuitable for administration.

According to universal rules, there are three key elements in the Cold Chain which are important to achieve proper vaccine transport, storage, and handling:

Trained People

All people in the chain are playing a key role in ensuring that the vaccines are kept within the required +2°C to +8°C temperature range when they are stored and transported.

All vaccinators must ensure that the vaccines they administer have been stored correctly, and be responsible for following the proper regulations.

Each provider must nominate at least two people (a primary and a delegate vaccine coordinator) who will hold overall responsibility for vaccine storage and temperature monitoring.

All clinical staff (including the maintenance staff, janitorial staff, and security staff members) must have read and understood, and must comply, with their provider’s cold chain policy.

Everyone involved are expected to take appropriate actions if the cold chain is not maintained properly.

Vaccine management systems and processes

There must be appropriate processes in place to ensure the continuity of the cold chain:

• monitor the vaccine storage conditions continuously
• manage the available stock of vaccines, so there are no shortages or overstocked conditions (minimum of 2 weeks but no more than 4 weeks of stock)
• prepare actions for power outage events
• make appropriate actions if the vaccines are exposed to temperatures outside the required range (+2°C to +8°C)
• dispose of expired or compromised vaccines properly

If a cold chain failure occurs, the compromised vaccines must be prevented from being administered to patients.

All immunization providers must have an up to date cold chain policy (it needs to be updated annually) that contains all required information. There is a cold chain policy template available at www.health.govt.nz/coldchain that provides the appropriate guidelines, and must be adapted accordingly.

Proper equipment

The approved equipment that is used for storing, transporting and monitoring vaccines must be fit for the purpose, and properly tested and maintained.

The correct equipment must be used from the time the vaccine is delivered to an immunization provider, until when the vaccine is administered to an individual.

All immunization providers must only use a pharmaceutical refrigerator for vaccine storage, which must be replaced every 10 years. Also, appropriate equipment has to be used for transporting and storing vaccines when a power outage occurs or the equipment fails.

The pharmaceutical refrigerator must:

• be left turned on and running at all times
• be plugged into a protected and independent power point; if not hard wired; also, a warning notice should be used to tell people not to unplug the unit, to help prevent the power cords from accidentally being removed
• be used to store only medicines and vaccines, consistent with the Medicines Act 1981, section 47
• be in a well-ventilated room that can be maintained at a temperature above 5°C and below 32°C all of the time
• be at least 4 cm, but preferably 10 cm away from any surrounding surfaces, to allow the air to properly circulate around the condenser
• not be in direct sunlight or against a heat source
• be levelled in a way that allows the door to close automatically if left ajar
• have its door seals and hinges in good condition to allow the door to close easily and securely
• be serviced annually by an approved/licensed refrigerator technician and documented
• have grille-type shelves inside for storage, to allow the air to circulate easily

Temperature Monitoring of the pharmaceutical refrigerator

The manufacturer or the provider must be able to monitor every new refrigerator on site using a minimum/maximum thermometer and data logger for a minimum of 24 hours before using them for storing vaccines, to ensure that the refrigerator is able to maintain the required +2°C to +8°C range, before putting them to active service.

The provider will need to keep all temperature recordings for the pharmaceutical refrigerator for 10 years.

Each refrigerator must have two forms of temperature monitoring equipment:

1. Daily check device, using a minimum/maximum thermometer with an externally visible display

The provider might be able to use the inbuilt refrigerator temperature recording device, but otherwise an external digital minimum/maximum thermometer with audible alarm should be used. The monitoring probe should be put inside a vaccine box, if not using a glycol solution.

The monitoring staff should take minimum and maximum temperature readings and record them once a day. It’s preferred to do it first thing in the morning, and then reset the monitoring device.

2. Weekly check device, using an electronic temperature recording device

Using a weekly check device does not override the need for the provider to constantly check and record the daily minimum and maximum temperatures, both are important.

The providers should also know the location of where the sensors are, for both the daily and weekly check devices. These devices should measure the temperature in different parts of the refrigerator, to get more accurate readings of the refrigerator temperatures and therefore must not share the sensor.

The data gathered from the weekly check device can be either stored electronically (as long as it is backed up properly) or on a paper system with the daily minimum and maximum recordings. The system must also allow access to the actual logger’s readings at a later date.

Using a data logger

Data loggers can come in many shapes and sizes. These are self-contained temperature recording devices, and they have to be configured on a computer before placing them in the refrigerator. The loggers’ accuracy at 0°C should range from ±0.2°C to ±0.3°C at temperatures of –10°C to +70ºC. The temperature recordings should be taken every 5-10 minutes, and downloaded weekly then compared with the daily minimum and maximum recordings to check for any unexplained temperature variations. The data storage needs to support rollover function, to ensure that the most recent data is still kept when the memory becomes full.

Using external monitoring services

Some pharmaceutical refrigerator suppliers offer an online monitoring and alerting service (external or cloud storage-based) with their devices. These devices can record and store their temperature recordings at set intervals (not more than 10 minutes) in the cloud from the local pharmaceutical refrigerator, and can be set up for SMS or email alerting.

The online service should offer detailed and accurate records of the whole temperature history that the provider can access, and provide a download and review of the collected data every week to compare it with the daily minimum and maximum recordings.

Cold Chain Accreditation

Cold Chain Accreditation (CCA) is an audit tool, which is used to assess the cold chain management practices and processes of the immunization providers, to ensure that they meet the standards for safe vaccine storage and transportation before offering them the ability to participate in an immunization program.

To achieve CCA, the provider first needs to conduct a self-assessment, and then an approved CCA reviewer will go to the site and conduct a review.

All immunization providers who will store vaccines all year round must have current CCA.

The CCA reviewer will assess the provider’s past performance (cold chain history) and current cold chain knowledge. The results of the assessment will help to determine the length of time CCA is awarded for. Further things that will be considered are the stability of the provider’s workforce, the age of the equipment. CCA can be awarded for up to three years.

This accreditation includes but is not limited to all general practices, emergency medical services, outreach immunization services, public health units, community pharmacies, travel clinics, corrections facilities, public and private hospital wards and departments/pharmacies, and occupational health services.

For general practices it is important to note that CCA is required to meet the Royal New Zealand College of General Practitioners Cornerstone® Standard (section 2, indicator 16) and the Foundation Standard.

The CCA assessment is based on the following five areas:

1. the provider has copies of, or has online access to all appropriate vaccine reference information

2. the provider has an appropriate and documented cold chain policy

3. the vaccine stock management is properly handled

4. the requirements for temperature monitoring and refrigerator performance are understood by all staff, and the monitoring devices and processes are appropriate

5. all of the used storage and transport equipment for the vaccines meets all requirements

The immunization providers must meet all of the requirements for the cold chain management to achieve CCA, and all staff must be responsible for the cold chain.

In the event a provider fails to meet the CCA requirements, the CCA reviewer will work with the provider to develop a remedial plan for the provider to achieve the requirements.

During this time, the provider may still administer vaccines while the remedial plan is in place, if the required temperature range of +2°C to +8°C can be maintained at all times and the provider works within the agreed timeframes outlined in the plan. The maximum recommended timeframe for completing such a remedial plan is three months.

However, if a provider is not willing to work on a remedial plan or does not keep to the agreed timeframes, the CCA reviewer will notify the PHO, DHB and medical officer of health or Medicines Control (in the case of a pharmacy). Further actions may be taken if necessary, which may include placing vaccine deliveries on hold.

Each DHB (District Health Board) is expected to work with the CCA reviewer and/or immunization coordinator, PHO (Primary Health Organization), medical officer of health, IMAC (Immunization Advisory Centre) and other immunization stakeholders to develop a process for working through issues in cases where providers are unable to achieve CCA.

This process may include steps such as:

• develop a provider remedial plan and the timeframes
• undertake another CCA reassessment
• follow up appropriately, in case the provider does not complete CCA requirements for some reason
• discuss the found issues with the IMAC regional immunization advisor, medical officer of health and PHO clinical lead
• formally notify and make recommendations to the provider for improvement
• revoke the existing CCA
• place the vaccine deliveries to the provider on hold

By 1 February 2018, all DHBs (District Health Boards) will be required to have a documented local process for addressing provider non-compliance. Each DHB has to review this process annually and make the documentation available to the Ministry on request.

The CCA Provider Self-Assessment Form and the CCA Immunization Provider Review Form can be obtained from the Ministry of Health’s cold chain page: www.health.govt.nz/coldchain

Cold chain compliance

A category called cold chain compliance (CCC) can be issued when an immunization provider meets all of the requirements for CCA, but is otherwise unable to show the past three-month continuous temperature monitoring records. This category can also be used when a new immunization provider is being set up.

CCC acknowledges that a number of immunization providers offer only short-term services, for example for administering influenza vaccine.

The CCC is issued through the same process as CCA: that is, the provider has to conduct a self-assessment, and then the CCA reviewer undertakes an immunization provider review before the provider can offer an immunization program or service.

A local certificate is issued for CCC and is valid for up to nine months.

It is expected that the CCC process will be undertaken before the provider begins its immunization program each year.

If a provider has already offered an immunization service in the previous year, then it must also produce its temperature recordings (the daily recordings and data logger downloads) from that year for the CCC review; the CCA reviewer will randomly review at least a quarter of these recordings.

CCC may also be applied for hospital settings, for areas where influenza vaccine is stocked. However, areas that would stock vaccines all year round will need to achieve CCA.

If a provider fails to meet the CCC requirements, the CCA reviewer will work with the provider to develop a remedial plan for the provider to achieve the requirements. However, during this time the provider will not be able to deliver an immunization service until it has met all of the requirements.

Cold chain audit

When a new vaccine arrives at the immunization provider’s facility, the provided temperature monitoring devices have to be checked.

One of the two lights will be flashing on the device; this is the only time the provider is required to check the logger.

A flashing green light indicates the temperature is within limits – the temperature has remained between +2°C and +8°C during transport.

A flashing red light indicates the temperature is out of limits – the temperature has NOT remained between +2°C and +8°C during the delivery period. All of the vaccines have to be quarantined in the delivery, and placed in the pharmaceutical refrigerator. DO NOT USE! The local immunization coordinator has to be contacted for further instructions.

Transporting vaccines using a chilly bin

Immunization providers must use temperature-monitored chilly bins (portable insulated container) to store vaccines when:

• a power outage occurs or equipment fails
• transporting vaccines to another provider
• defrosting refrigerators
• running off site clinics, for example, school-based immunization programs, outreach immunization services or workplace settings

General principles

• Vaccines need to be kept between +2°C and +8°C at all times.
• Only use polystyrene plastic chilly bins for temporary storage during refrigerator maintenance, or during transport to another provider (either planned or as a result of a power outage or equipment failure).
• A more robust chilly bin has to be used for off site clinics.
• For each chilly bin, use sufficient ice packs and insulation material.
• For each chilly bin, monitor the temperature using either a digital minimum/maximum thermometer with audible alarm or a data logger with probe and an external display (depending on the reason for using the chilly bin). It must be possible to read the temperature without opening the chilly bin.
• Providers are expected to trial their equipment and be able to show that they can maintain the temperatures between +2°C and +8°C at all times.
• Start cooling the chilly bin at least 30 minutes before vaccines are placed inside it.

Monitoring chilly bins for transport and temporary storage

Providers must have a minimum/maximum digital thermometer with audible alarm to measure the temperature of vaccines when using chilly bins to transport or temporarily store vaccines, for example, during a power outage or refrigerator servicing.

Also, the staff should check and record the minimum, maximum and current temperatures of the vaccines:

– before transporting the vaccines

– before unpacking them at the alternative storage area

– every 20–30 minutes while transporting or temporarily storing them.

Monitoring chilly bins for storage in offsite immunization clinics

• It’s necessary to use a data logger with a probe, external display and alarm to monitor the temperature of the vaccines throughout the time they are stored in chilly bins at an offsite vaccination clinic (consider using a secondary back-up device, ex, digital minimum/maximum thermometer, in case the data logger gets damaged)
• Special consideration should be given to having the ability to download the data logger while it is away from base, if a review function is not available on the logger
• It’s needed to record the minimum, maximum and current temperatures every 20–30 minutes after putting the vaccines in the chilly bin
• The data logger has to record the temperature every five minutes; then download, review and save the data after returning to the clinic.

Providers must keep documentation associated with monitoring the temperature of vaccines in chilly bins for 10 years, along with the rest of the cold chain documentation.