Cold chain encompasses the infrastructure, the equipment, the people and the management processes and its implementation. The following criteria (adapted from WHO Effective Vaccine Store Management initiative) are universal conditions that can be used during any cold chain assessment.
Assessing the Management Processes
Assess the availability of a cold chain management policy or standard operating procedures. It should be available and applied. Cold chain management policy or standard operating procedures should include clear information on:
- Designated staff members responsible for the cold chain management, including the decision makers accountable for ensuring the required resources.
- Vaccine stock requirements specific to the workplace, both in terms of volume and temperature ranges.
- The “safety stock level” and the “maximum stock level” for each vaccine. Stock levels should be maintained between this range.
- Vaccine ordering and stock management processes, including:
- Stock records.
- Process to order, receive and dispatch vaccines, including the equipment required in all deliveries, such as Freeze indicators.
- Standardised recording and reporting of all stock transactions.
- Process for managing damaged vaccines and respective process for quarantine, disposal or reverse logistics.
- general warehousing practices like periodic physical inventories.
- Temperature monitoring process: required equipment, templates, schedule and reporting processes.
- Operation and maintenance plan, including a specific schedule for all the cold chain equipment. It should include a designated person or service provider responsible for the servicing of the power sources and cooling equipment.
- Actions if the temperature recordings are outside the +2°C to +8°C range.
- Emergency plans and equipment for use in the event of refrigerator failure and/or power outage, including a nominated back –up provider.
- The processes to ensure sufficient funds to cover the required equipment and consumables. A replacement plan for cold chain equipment reaching the end of its lifespan should be considered.
Assessing Cold Chain Equipment
The assessment of the cold chain equipment should include both active and passive cold chain devices as well as other cold chain material such as coolant packs and temperature monitoring equipment. For the existing cold chain equipment, assess:
Capacity - The capacity of cold storage should be sufficient to meet the demand. The store should be able to accommodate peak stock levels for all the vaccines in the program, including campaign vaccines.
Load - The vaccines should be correctly arranged inside the refrigerators, letting enough space for the cool air to flow. Each device containing vaccines should be equipped with (at least) one thermometer or data logger. Temperature monitoring sheets should be attached to the device and records up to date.
Temperature performance - All vaccines should be stored within recommended temperature ranges. Continuous temperature records should be available, and demonstrate that vaccine has been stored correctly. Devices used for temperature recording should have an accuracy of ± 0.5°C.
There shouldn’t be evidence of freezing in the vaccine compartment (noting the means of verification: electronic monitoring data, manual temperature data, shake test). Presence of frozen vaccine vials should be checked as well as the presence of water droplets or wetness on walls of the vaccine compartment or on vaccine vials or boxes
Condition and robustness - Assess if the equipment broke or malfunctioned in the near past and how often this happened. Also, if repairs were performed, indicate the type of repair and if spare parts were used. It is important to consider if the malfunctioning resulted in the inability to use the equipment.
The age and past handling of the equipment could be a vulnerability factor: assess its first “use date” and past history. Be aware that refrigerators have a life duration of about 10 years.
The infrastructure should enable the cold store to function effectively. This includes the adequateness of the store building (the location and the construction standard) and the basic utilities, particularly the power supply feeding the active cold chain.
All infrastructure should be of a satisfactory standard and correctly maintained through planned preventive maintenance. Emergency repairs should be exceptional and conducted in a timely manner. There should exist reports on maintenance and repairs. Adequate supplies of spare parts, consumables and fuel should be available. If relying in an emergency generator, it should be also well serviced and operational.
Assessing Human Resources
The assessment of the human resources involved in the cold chain management should include (1) the responsibilities, (2) the correct staffing and (3) the knowledge and capacities.
The responsibilities and tasks should be clearly specified for each person with a role to play in the cold chain management. To assess it, verifying the availability and accessibility to job descriptions is the straight manner. Responsibilities related to cold chain management should be described for all management levels and for every step of the chain: from the personnel monitoring temperatures to decision makers and budget holders.
There should be enough Human resources to operate the store effectively. Even in the smaller vaccine store sites, two or more staff should be appointed to ensure the coverage during unexpected events. A work-plan should guarantee the coverage throughout the whole year.
All the pertinent personnel should be trained in the management of the cold chain. Records of assistance to briefing or training sessions could demonstrate these. In addition, the personnel should have access to the guidance policy or the standard operational procedures.