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Standards for general practices (4th edition)

including Interpretive guide for Aboriginal and Torres Strait Islander health services

Standard 5.3 Clinical support processes

Our practice has working processes that support safety and the quality of clinical care.

Criterion 5.3.2

Vaccine potency

Our practice maintains the potency of vaccines.

Indicators

► A. Our practice team can identify the person with primary responsibility for cold chain management within the practice.

► B. The person with primary responsibility for cold chain management has this responsibility defined in their position description and can describe how the process used for cold chain management complies with the current edition of the National Vaccine Storage Guidelines.

► C. Our practice can demonstrate how we review the following processes to ensure potency of our vaccine stock:

  • ordering and stock rotation protocols
  • maintenance of equipment
  • annual audit of our vaccine storage procedures
  • continuum of cold chain management, including the handover process between designated members of the practice team
  • accuracy of our digital vaccine refrigerator thermometer.

Explanation

Key points

  • The success of any vaccination program depends on the potency of vaccines when they are administered to patients
  • A cold chain management system for the transportation and storing of vaccines aims to keep vaccines within the safe temperature range of 2–8ºC
  • Self auditing of cold chain management should form part of a routine quality assurance and risk management process
  • There needs to be a member of the practice team with primary responsibility for cold chain management.

National Vaccine Storage Guidelines

Vaccines are delicate biological products and if not stored appropriately they become ineffective.

The essential references for this criterion are:

  • the current edition of the National Vaccine Storage Guidelines: Strive for 5, and
  • the current edition of the NHMRC Australian Immunisation Handbook.

These references outline the requirements for general practices and other immunisation providers in relation to cold chain management and are available online at www.immunise.health.gov.au.

Essential steps in proper cold chain management

For practices to be confident that the potency of vaccines is maintained, practices must:

  • monitor and record the maximum and minimum temperature of refrigerators in which vaccines are stored at least once daily when the practice is open, before any vaccines are used (generally at the beginning and end of each working day)
  • have a reliable refrigerator, capable of maintaining a stable temperature and of adequate size for the practice’s storage needs and frequency of vaccine ordering
  • develop routine processes to maintain the cold chain, which are clearly documented. This may include identification, through a risk analysis, of potential situations of risk to vaccine potency and documentation of appropriate management strategies
  • ensure that all practice staff handling vaccines receive ongoing education (supported by the practice) that is appropriate for the responsibility in performing their role
  • know what action to take (including reporting and documentation) if the temperature of the refrigerator has been outside the recommended range of 2–8ºC.

Refrigerators

Vaccines should be stored in an appropriate refrigerator. If the practice is using a domestic refrigerator, certain modifications are necessary to reduce the risk of adverse vaccine storage events. This may include a combination of the following:

  • a digital thermometer probe placed in the vicinity of stored vaccines to monitor the maximum and minimum refrigerator temperature
  • storage of vaccines in their original packaging in a set of sliding plastic drawers or enclosed plastic containers to increase insulation (never in the door of the refrigerator)
  • placement of bottles of salt water or unfrozen ice packs/gel packs in unused areas (eg. refrigerator door or identified colder areas of the refrigerator) to help stabilise the temperature.
  • temperature ‘data loggers’ that can be placed in various vaccine storage areas to measure temperatures and keep a record of temperature fluctuations over a period of time.

Note that cyclic defrost and bar refrigerators are not recommended because they produce wide fluctuations in internal temperatures.

Data loggers

Data loggers can be used in audits to verify cold chain efficacy and to enable a quality control check of the vaccine refrigerator temperature. They are small electronic devices that continuously measure temperatures and keep a record of the results over a period of time. They require computer software to download the readings. Data loggers may be inbuilt in some vaccine refrigerators, or external data loggers may be purchased. (Data logging services are provided by some state/territory immunisation programs and some local divisions of the Australian General Practice Network.)

Data loggers are useful in determining and recording:

  • the accuracy of the refrigerator thermometer
  • temperature fluctuations within the refrigerator and how long the refrigerator stayed at this temperature
  • potential cooler or warmer areas within the refrigerator – areas which may not be suitable for vaccine storage.

Nominating a person with primary responsibility

A member of the practice team needs to be nominated to take primary responsibility for cold chain management and achieve compliance with cold chain management guidelines. The role and responsibilities need to be clearly articulated within a position description and there should be the opportunity for appropriate training as required. There needs to be a process for handing over to another designated and trained staff member when the responsible person is unavailable to perform their duty.

Self auditing

Routine self auditing helps to ensure that potent vaccines are being administered. An example of a self audit is contained in the appendix of the National Vaccine Storage Guidelines: Strive for 5 (see page 117).

Standard 5.3 Clinical support processes

Our practice has working processes that support safety and the quality of clinical care.

Criterion 5.3.2

Vaccine potency

Our practice maintains the potency of vaccines.

In a nutshell

Vaccine potency is dependent on an effective cold chain management system for transportation and storing of vaccines. A member of your health service team needs to have primary responsibility for cold chain management, and to ensure that self-auditing becomes a routine part of quality assurance and risk-management processes. Relevant clinical and administrative staff need to understand and be able to explain how the service ensures the potency of vaccine stock.

See Criterion 5.3.2 Vaccine potency of the Standards for general practices for the two essential references for this criterion.

Also see the Other information for Standard 5.3 for resources on cold chain management for remote health services. 

Key team members

  • Staff member designated with primary responsibility for cold chain management
  • Clinic manager
  • Health service manager
  • Clinic staff

Key organisational functions

  • Cold chain management system, including cold chain management policy and procedures
  • Quality assurance and risk-management processes
  • Quality and safe clinical practice
  • Safe and quality use of medicines

Indicators and what they mean

Table 5.7 explains each of the indicators for this criterion. Refer to Criterion 5.3.2 Vaccine potency of the Standards for general practices for more information and explanations of some of the concepts referred to in this criterion. 

Table 5.7 Criterion 5.3.2 Vaccine potency
IndicatorWhat this means and handy hints
▶ A. Our practice team can identify the person with primary responsibility for cold chain management within the practice. A staff member needs to be designated with specific responsibility for cold chain management in your health service. This staff member should be well known to all clinic staff and be able to support clinic staff in maintaining the potency of vaccines used by the health service.
▶ B. The person with primary responsibility for cold chain management has this responsibility defined in their position description and can describe how the process used for cold chain management complies with the current edition of the National vaccine storage guidelines. The person with primary responsibility for cold chain management would have their role and responsibilities clearly defined in their position description and receive training appropriate to this responsibility.

The person needs to be familiar with the processes explained in the essential references for this criterion and describe how the health service’s process complies with:
  • the current edition of the National vaccine storage guidelines: Strive for 5
  • the current edition of the NHMRC Australian immunisation handbook.
Your health service’s designated person should be familiar with the requirements for general practice in relation to cold chain management. It is recommended that a policy and procedure manual ensure compliance with the National vaccine storage guidelines.

At least one other person should be nominated to deputise for the above person if they are away at any time. This person should be properly trained and authorised for cold chain management responsibilities.
▶ C. Our practice can demonstrate how we review the following processes to ensure potency of our vaccine stock:
  • ordering and stock rotation protocols
  • maintenance of equipment
  • annual audit of our vaccine storage procedures
  • continuum of cold chain management, including the handover process between designated members of the practice team
  • accuracy of our digital vaccine refrigerator thermometer.
This indicator is important for ACCHSs, because preventive health programs for the community and services for patients involving vaccinations are only as effective as the potency of vaccines that are administered to patients. Therefore the identified processes to ensure potency of vaccine stock are vital.

Routine internal auditing helps to ensure that potent vaccines are being administered. For an example of a self-audit, please refer to the appendix to the National vaccine storage guidelines: Strive for 5.

Case study

Below is a description of the ways in which an Aboriginal community controlled health service can maintain the potency of its vaccines. Not all of these good practices are required by the Standards, but they illustrate the many practical and creative things that ACCHSs can do to ensure they deliver services of high safety and quality to their community.

A staff member at each clinic has designated responsibility for cold chain management and this is documented in their job description. Each health service clinic has a backup staff member who is able to manage the cold chain of vaccines if the designated staff member is ill or on leave.

The staff induction process includes cold chain management and staff training logs show records of cold chain in-service training. When interviewed, the designated staff members are able to demonstrate the procedures of cold chain management, from stock ordering to the accuracy of the digital thermometer in the refrigerator used to store vaccines.

The service has the latest edition of the Australian immunisation handbook and National vaccine storage guidelines: Strive for 5 available for staff reference.

Staff members are aware of the importance of promptly notifying the designated staff member when a vaccine delivery arrives.

Each clinic has purpose-built vaccine refrigerators, which are serviced on a regular basis and in response to unacceptable variations in temperature outside the recommended range.

The smaller clinic, which suffers from power interruptions, has a backup generator for maintaining electricity to the vaccine refrigerator.

The service’s policy and procedure manual details the processes for:

  • ordering and receiving vaccines
  • monitoring and recording the temperature of the vaccine refrigerator, at a minimum daily
  • rotating stock so that vaccines with the shortest expiry date are used first
  • monitoring and adjusting equipment such as the data logger, thermometer and thermostat
  • equipment maintenance – for example, changing batteries in the thermometer, checking the accuracy of the thermometer
  • action to take if the refrigerator temperature goes outside the recommended range, including what to do and how to prevent it happening again – for example, to report to the appropriate state or territory health department and document the incident
  • how to pack a cooler for outreach clinics
  • how to manage a power failure.

Designated staff members provide induction to new staff members and in-service to other staff members on the importance of the vaccine deliveries and what to do if they hear the vaccine refrigerator alarm going. They also check the vaccine refrigerator seals monthly for perishing or any damage.

A self-audit is conducted by designated staff members every six months, to determine:

  • current staff members’ knowledge of the cold chain process and whether they know that the vaccine refrigerator is not to be unplugged and no food or drinks are to be stored in it
  • if a record is available to show that the temperature has been checked each working day
  • whether there is a valid documented reason if monitoring has been missed
  • whether all deviations of temperature outside the acceptable range were reported to the appropriate state or territory health department
  • if there is an appropriate gap between the vaccines and the walls of the refrigerator
  • whether vaccines are stored in their original packaging in a set of plastic drawers or enclosed plastic containers to increase insulation
  • if the refrigerator can continue to store the volume of vaccines safely as required by the service.

Showing how you meet Criterion 5.3.2

Below are some of the ways in which an Aboriginal community controlled health service might choose to demonstrate how it meets the requirements of this criterion for accreditation against the Standards. Please use the following as examples only, because your service may choose other, better-suited, forms of evidence to show how it meets the criterion.

  • Through the use of staff interviews.
  • Use job descriptions.
  • Maintain a policy and procedure manual.
  • Maintain a vaccine refrigerator temperature log.
  • Maintain a staff training log.
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