Module 1: Managing Blood and Blood Product Transfers - Implementation

Requirements for packing and transport

Health providers should agree to a validated method for packing and transporting blood and blood products and document in an MOU.

Handling of Blood and Blood Product

Care must be taken when handling blood and blood products. In particular the following steps should be completed:

• minimal physical handling of all blood and blood products must be practiced to ensure those products are kept within their recommended temperature ranges;
• ensure that when you are handling any red blood cell product that it is not exposed to temperatures outside refrigeration specifications for longer than 30 minutes;
• ensure that when you are handling any frozen blood products outside storage conditions that it is kept on dry ice or frozen ballast within a container to prevent temperature changes;
• the blood and blood product bag and/or packaging integrity must be inspected before sending to another health provider;
• management of out of specification consignments to be included in the MOU.

Packing requirements

Blood and blood products must be packed for transport in accordance with the validated specifications agreed to between participating health providers.^7,11 If packing materials such as dry ice are used it is recommended that relevant policies and procedures are developed and appropriate training is provided for staff.¹²

When choosing validated packing methods, you may like to consider implementing existing validated shipper configurations. For example an existing validated blood and blood product packing configuration and transport times is detailed in Australian Red Cross Blood Service Receipt and Use of Blood Service Shippers by External Institutions to Transport Blood and Blood Products¹⁰ and Transportation of blood components and fractionated products¹³. The Blood Service recommend the use of data loggers outside their validated transport times¹⁴ with specific packing configurations.

You may wish to validate your own shipper configurations or the shippers and packing configurations used by the Blood Service for extended time frames. Principles and guidelines on validation can be found in the National Association of Testing Authorities Guidelines for the validation and verification of quantitative and qualitative test methods.¹⁵ An example of one method of shipper validation is located at Appendix 2. Validation data must be documented, reproducible and available to NATA on request.

Consideration of the ambient temperature is important when transporting blood and blood products.¹⁶ There are vast temperature differences across Australia that can affect transport shipper validation times and ensuring blood and blood products remain within manufacturer’s temperature specifications.
It is important to consider all temperature conditions and length of time that may be experienced by the blood or blood product you are packing and transporting. Think about where your blood or blood product is being transferred to and all the environments the shipper may experience. The validation process must be repeated for all possible temperatures the blood and blood product may be exposed to during its transport. Some examples of items to consider when transferring blood and blood product include:

• If the product is going by plane:
  • the cargo hold might not be heated resulting in very low temperatures
  • the items might be held in air conditioned storage before or after the flight
  • the items might be left on the tarmac for some time in extreme hot or cold temperatures.
• If the product is traveling by road:
  • it may travel long distances on a truck that could experience extremes of hot or cold temperatures
  • it might be left on a loading dock for an extended period of time before arriving at the storage site.

Consider conducting initial and ongoing seasonal courier temperature audits and ad hoc quality assurance audits as required. If you are transporting blood or blood product outside of a validated timeframe or condition you must ensure manufacturers’ temperature specifications are met.¹¹  Where a validated shipper has a minimum number of packs specified, ballast must be used to ensure minimum numbers are maintained.

Transport requirements

Blood and blood products must be transported at the temperature range specified in Table 1.

Table 1: Transport temperature manufacturer's requirements

#Adapted from the Australian Red Cross Blood Service (2012). Blood Component Information, circular of information¹⁷

It is recommended that a temperature data logger, or other temperature monitoring device, is utilised in the transport of all blood and blood products. Various temperature monitoring devices are available on the market.

Transfer procedure outline

There are a number of elements to consider when transferring or receiving blood and blood product. Below are suggestions you may wish to include in your MOU.

Transferring out blood and blood product

It is important to allow sufficient time for receiving facilities to utilise blood and blood products before expiry. The recommendations below are given to ensure the receiving site has the highest likelihood to use the product before expiry;

• 7 - 14 days before expiry for red blood cells,
• >5 days before expiry of supplier irradiated blood cells,
• 24 hours, or as short as agreed to with the receiving site, before expiry for platelets,
• 1 - 3 months before expiry for manufactured products.

You may wish to introduce a system to improve utilisation of short expiry products. For example, the sending laboratory should phone the receiving laboratory to see if they can use the product prior to expiry.

The receiving health provider should be notified of an impending delivery within a time frame agreed between sites in the MOU [e.g. 24 hours’ notice]. This notification will allow sufficient time for receiving facilities to adjust their own inventory orders from the supplier. If relevant, outline in your MOU multiple hub and spoke arrangements to ensure that if one health provider is unable to accept a transfer another arrangement is in place.

Details of blood and blood product transfers should be recorded in BloodNet prior to transport for facilities with access to BloodNet. The BloodNet transfer receipt form, or equivalent, should then be printed and added to the shipper for transportation with packing date, time and signature of packer. Health providers without access to BloodNet should complete the transfer form in Appendix 6 to accompany their shipment.

It is important to inspect all blood and blood products for prior to packing. You should consider documentation of the inspection in your MOU. A checklist to check blood and blood products is available for receiving sites in Appendix 6.

Your MOU should include the agreed shipping configurations and container specifications for the varied climates your locations will face. This should assure all participating health providers in the MOU that blood and blood products are maintained within the recommended manufacturer’s temperature specifications.

A record of the storage temperature of the products must be available on request at the facility that shipped the product. NATA accredited health providers may need to provide this documentation during their accreditation process. This documentation will assure all participating health providers are storing blood and blood products within the current AS3864 Medical refrigeration equipment – For the storage of blood and blood products⁶. It will also provide assurance that blood and blood products are maintained within manufacturer’s temperature specifications and prevent discards due to unknown storage conditions.

Consider what documentation will be required with transfers in the MOU. Recommended documentation and information is:

• name of shipping health provider and receiving health provider
• identification of components/products shipped (donor numbers) and description of component/product and total number of units transferred
• date and time transfer entered into BloodNet, where applicable
• date and time packed
• identification of person who packed the shipment
• inspection of product appearance attended
• transfer procedure checklist, see Appendix 4
• shipper Packing Slip for sites without BloodNet, example available in Appendix 7

* The above documentation can be recorded on the printout from the BloodNet transfer episode or on the Blood and Blood Product Transfer Form available in Appendix 6 of this document.

Labelling of shipping containers

It is important to label blood and blood product transport shippers appropriately. See Appendix 8: Shipper Label for an example. Consider including the following details as a minimum;

• name and phone number of contact person at the receiving site,
• name and address of intended receiving site,
• dispatch time and date,
• dispatching health provider, staff member name and contact details,
• clear and precise instructions to the courier contractor.

Receiving blood and blood product

When receiving blood and blood product transferred from another health provider, consider the following:

• Review your current inventory and routine stock orders to account for expected transfers into your facility. This may require you to reduce your routine order. For example, if you know you are receiving 20 units of red blood cells, reduce your order by 20 units unless you know that more is required that day.
• Document the time and date the transferred blood and blood product was received on Appendix 6: Blood and Blood Product Transfer Form and whether temperature specifications have been met. This will ensure you have completed records for accreditation purposes.
• It is the responsibility of the receiving facility to ensure the blood and blood product has been maintained within the manufacturer’s required temperature range before accepting it into your inventory. If in doubt, the product must be quarantined until storage and transport conditions have been verified.¹¹ Please refer to the Australian & New Zealand Society of Blood Transfusion Guidelines for pretransfusion laboratory practice.¹¹
• It is good practice to inspect the shipper and blood product upon receipt as per Appendix 6: Blood and Blood Product Transfer Form. This ensures the integrity of each unit and that patient safety is maintained.
• Enter the acceptance or non-acceptance of product into your laboratory information system as required. To ensure traceability, it is important that all laboratories with access to BloodNet must enter their transfers and discards.
• You should maintain a record of transferred products for auditing and accreditation purposes. This can be completed through BloodNet or manually if the transferring and/ or receiving site does not have access to BloodNet. This will allow you to review the transfer arrangements and track if transferred products are utilised, if discards rates of expired product decrease and so on.

Remote sites without a laboratory or blood fridge

For non-laboratory remote sites with a blood fridge consider who is responsible for maintaining the fridge. The receipting site is responsible for ensuring that all product received has been kept within manufacturer’s temperature specifications and will need to include access to temperature records in the MOU. You may also want to consider including any maintenance records. Alternatively, you may choose to opt for a signed declaration that all blood and blood product has been maintained within manufacturer’s temperature specifications, by the transferring out site.

For remote sites or facilities without a laboratory you may like to include the following additional documentation with the transferred blood and blood products as an assurance for the receiving facility that blood and blood product have been stored according to manufacturers’ temperature requirements;

• completed paperwork outlining the daily storage temperature checks of the blood fridge or storage area, see Appendix 5: Blood Fridge Maintenance Record;
• a photocopy of the objective graph recorder from the blood fridge demonstrating the temperature range of the place of storage; or
• information from the health provider responsible for maintaining the blood fridge, for example temperature graphs, maintenance records. You may be satisfied with a declaration from the sending health provider.

For remote sites without a blood fridge consider how blood and blood products are stored while onsite and include specific storage methods in your MOU. Examples of inclusions include, but are not limited to;

• the product must remain in a sealed shipper until used,
• the product must be accompanied by a data logger or temperature indicator,
• transfer of patient specific product only for immediate use.

For remote sites without a blood fridge, storage and transport requirements and documentation must be detailed in the MOU.

Staff at the remote site should undertake the BloodSafe eLearning "Transporting Blood" module. The receiving laboratory could also consider undertaking additional training for ward/nursing staff at the remote site.

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