RBC Component Storage

All components containing RBC (Whole Blood, LR, AS-3 RBC, LR, Red Blood Cells, LR, (CPDA-1 and CP2D) must be stored at 1- 6°C. Shelf life depends upon the anticoagulant/additive used.

See the table below for the shelf lives of common components in a closed system. In an open system, components stored at 1 - 6°C must be used within 24 hours.

Additional storage information may be found in the Circular of Information for the Use of Human Blood and Blood Components (Section C.7).

Time Limitations

Units must not be out of the controlled environment of the blood storage refrigerator for longer than 30 minutes to be eligible to be placed back into inventory.

This is required by all current standards and should be followed by all transfusion services and closely monitored by all personnel who handle or transport blood components. This standard and the shelf life are established to ensure the efficacy of the component and to prevent bacterial contamination of the component.

As well, transfusion should be completed within four hours of the time the component is removed from the controlled refrigerator.

Shelf Life

Component	Shelf Life	Anticoagulant/Nutrient
AS-3 RBC, LR	42 days	Citrate Phosphate Double Dextrose and Nutricel™ additive
CP2D RBC, LR CP2D Whole Blood, LR	21 days	Citrate Phosphate Double Dextrose only
CPDA-1 RBC, LR CPDA-1 Whole Blood, LR	35 days	Citrate Phosphate Dextrose Adenine

Specifications for Whole Blood and Blood Component Storage Devices

Blood component storage refrigerators are specially manufactured for this purpose. The following are requirements for refrigerators for whole blood and blood component storage:

• have a validated continuous recording device or be connected to one. If there is no continuous recording device, the temperature should be documented manually using a calibrated thermometer every four hours.
• have an audible alarm system with audible signal.
• be equipped with a fan and/or proper circulation to ensure constant temperature throughout the cabinet.

The CSA Standards for Blood and Blood Components (Z902-04) state that calibration of equipment must occur on a regular basis using an established procedure.

Canadian Society for Transfusion Medicine (CSTM) Standards requirements state that the alarm and back-up power supply for blood storage equipment must be checked at regular intervals and documented.

The most commonly used reference for a procedure for alarm calibration is the Technical Manual of the American Association of Blood Banks (AABB).

• This method uses calibrated thermometers, crushed ice for lower alarm calibration and warm water for upper alarm determination. In the procedure, the calibrated thermometer is placed with the temperature-sensing device to equilibrate.
• The thermometer and sensor are then placed in the water or ice mixture and the temperature of the calibrated thermometer read when the device alarms.

Examples of manufacturers of blood storage equipment (with specifications)

Laboratory Operating Requirements

1. The laboratory must have written procedures that contain directions for actions to take in the event of a power failure or malfunction.
2. Whole blood and components should be stored in a separate area from donor and patient specimens as well as reagents.
3. A secure area, segregated from available inventory, is required for autologous, donor-directed and other quarantined units.

Platelet Componet Storage

Platelet components must be stored at 20-24°C under continuous agitation. Their shelf-life is five days from the date of collection.

Platelet products, as a biological and with room temperature storage conditions, carry an increased risk of bacterial contamination because of their storage at room temperature. Transportation time should not exceed 24 hours.

Additional information on storage may be found in section D.7 of the Circular of Information for the Use of Human Blood and Blood Components.

Time Limitations

Health Care Facilities should have operating procedures in place that clearly define acceptable timeframes:

• for platelets to be in transit within the facility
• from the time platelets are released from the transfusion service until transfusion is complete

Specifications for Platelet Component Storage Devices

Platelet agitators and incubators for platelet component storage are required. If the agitator is not contained in a platelet incubator, the ambient temperature must be recorded manually every four hours as long as platelet components are stored, to ensure that a storage temperature of 20-24°C is maintained.

The laboratory must have written procedures that contain directions for actions to take in the event of a power failure or malfunction.

Examples of manufacturers of platelet agitators and incubators

When there is no Platelet Component Storage Agitator/Incubator in the Hospital Transfusion Service

Many small laboratories do not have a platelet agitator and/or incubator but occasionally must order platelets for transfusion. In these cases, a Standard Operating Procedure (SOP) that addresses this type of situation should be written. In the SOP, the following items should be included:

• The policy should state that platelets are not stored on site but, when needed for transfusion purposes, are issued immediately upon receipt from the blood supplier
• The communication mechanism with nursing to ensure that the component is used as soon as possible after receipt
• The policy and procedure should include steps to determine if the platelets have not agitated for more than 24 hours while in transit. If more than 24 hours have passed, the platelets should not be used for transfusion (or the medical director responsible for the transfusion service must authorize the issue of such platelets after determining the clinical need with the patient's physician)
• Record the ambient temperature manually when the product is received and every four hours until issue
• Documentation of the receipt and issue times as well as the authorization (who and when), if authorization was necessary
• Include visual inspection criteria for platelet components. When components are rarely used in a facility, it is important to provide criteria for technologists to use when handling the units.

Further Reading

Frozen Plasma and Cryoprecipitated AHF Component Storage

All frozen components must be stored in a controlled, monitored freezer. See the table below for shelf-life of common components in a closed system. When the system is "opened", components stored at 1-6C must be used within 24 hours. Additional information on storage may be found in the following sections of the Circular of Information for the Use of Human Blood and Blood Components:

• Frozen plasma, LR: Amendment 1
• FFP, LR and FFP, Apheresis: E.7
• Cryosupernatant Plasma,LR and Cryoprecipitated AHF, LR: F.7

Shelf Life

Component	Shelf Life When Frozen	Shelf Life When Thawed
Frozen Plasma, LR	12 months at -18C or colder	4 hours stored at 1-6C
FFP, LR, FFP Apheresis, Cryosupernatant Plasma, LR	12 months at -18C or colder	24 hours stored at 1-6C
Cryoprecipitated AHF, LR	12 months at -18C or colder	Up to 4 hours stored at 20-24C

Specifications for Blood Component Storage Devices

Blood component storage freezers are specially manufactured for this purpose. The following are requirements for frozen blood component storage. Storage must:

• have or be connected to a validated continuous recording device. If there is not continuous recording device, the temperature should be documented manually using a calibrated thermometer every four hours.
• have an alarm system with an audible signal.

Examples of manufacturers of blood storage equipment (with specifications)

Laboratory Operating Requirements

The laboratory must have written procedures that contain directions for actions to take in the event of a power failure or malfunction.

Contingency Plan in Case of Malfunction

All laboratories should have written procedures that identify the steps to follow when critical equipment malfunctions. A Standard Operating Procedure (SOP) that addresses this type of situation should be written. The SOP should include steps for interim storage of blood components. These may include but are not limited to:

• Not opening the freezer when malfunction is found.
• Contact names for notification and for repair.
• Careful monitoring and documentation of temperature. When the temperature is close to the upper temperature limit, steps to remove the blood products for shipment to an alternate storage freezer.
• Use of blood component transport containers for shipment to nearby freezer or facility for storage.
• Monitoring of temperatures when an alternate freezer is located/used. If there is no continuous monitoring device on this freezer, the temperature must be read and documented every four hours.

Further Reading