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Shipping & Distribution

Ordering Components | Delivery of Components
Return of Components | Storage and Handling | Derivatives/Reagents
Billing Processes | Facility Inspection & Shipping Quality Control

The Hospital Services department of Blood Centers of the Pacific (BCP) distributes blood products to hospitals and other transfusion facilities for patient use. Hospital Services is also responsible for handling patient specimens requiring testing at the blood center and blood products returned to the blood center.

Each transfusion facility must sign a "Hospital Services Agreement" detailing expectations and requirements for delivery and storage of blood products, return privileges when applicable, and special services provided by Blood Centers of the Pacific.

This section of the Web site covers topics related to the order and delivery of blood products, in addition to other issues covered in the Agreement, Contact Hospital Services for routine communications or the Hospital Services Director for other questions you may have.

ORDERING COMPONENTS FROM BLOOD CENTERS OF THE PACIFIC

Stock Orders

It is the goal of Blood Centers of the Pacific to maintain a minimum inventory of red blood cells equivalent to a 5-day supply. Relative to the distance from the blood center and the type of patients each hospital should maintain a 2 1/2 to 5 day red blood cell supply.

The following guidelines are used by BCP for time frames to ship regular orders. Stated time is from the order time to when the shipment leaves the center.

  • STAT: Not more than 1 hour from the time an order is taken to the time it is shipped.
  • ASAP: Not more than 2 hours from the time an order is taken to the time it is shipped.
  • Stock (standing orders/routines): Order is shipped as workload and product availability permit, but not later than 8 hours from the time the order is taken.

Whenever possible, BCP requests the use of shorter dated units first, and the timely release of untransfused, crossmatched blood for other patient use or return to the blood center.

When placing an order, indicate type(s) of blood component(s), quantity and time frame for delivery.

Special Orders

Special Orders are for components that require special handling, testing, or components not available in stock at BCP. Not all blood centers may provide the complete list of options.

PEDIATRIC COMPONENTS
Units requested for pediatric use may be aliquoted by BCP or supplied with a satellite bag (or bags) attached to the primary unit for aliquoting at the Transfusion Facility.

WASHED
Red Cells or Platelets requested as washed have a reduced outdate (24 hours and 4 hours respectively).

IRRADIATED
Cellular components can be requested as irradiated. Directed Donor units from blood relatives require irradiation.

DIRECTED DONOR/ AUTOLOGOUS
These reserved units must be ordered to be drawn prior to transfusion need by the patient's attending physician. (See Special Collections.)

ANTIGEN NEGATIVE
Red cell units can be supplied as confirmed or unconfirmed depending on transfusion facility request and blood center policy. Rare units may be available as liquid or frozen, but may need to be imported from another center. If frozen, BCP will deglycerolize the unit prior to delivery; this shortens the shelf life of the units to 24 hours.

CMV SERONEGATIVE
Cellular components can be requested as CMV seronegative.

HGB S NEGATIVE
Red cell components can be requested as Hgb S negative.

GRANULOCYTES
Collected only after discussion with the BCP Medical Director.

WHOLE BLOOD
Available at special request.

Special platelet considerations:

REDUCED VOLUME
Platelet pheresis components can be prepared to remove plasma volume. This process shortens the shelf life to 4 hours from the time the process starts, and allows only a very short time for administration at the Transfusion Facility.

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Emergency Release Process

A discussion with Hospital Services and/or the Blood Centers of the Pacific Medical Director may facilitate the process for delivery of these special units.

Units that are not yet completely tested require release following the Blood Centers of the Pacific Emergency Release Process. Whole blood and blood components may be issued only when such issue is essential to allow time for transportation to ensure arrival of the blood by the time it is needed for transfusion. Contact the Special Donations department for the proper documentation for Emergency Release.

Certain components that cannot be completely tested may also be released upon approval by the attending physician (and our receipt of a signed Emergency Releasae Document available from your blood center representative). Rare, unlicensed frozen units fall into this category.

Process for Issuing Unlicensed Components

Certain components are only available as unlicensed by FDA. The requesting physician must supply a medical need statement for delivery of these products.

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DELIVERY OF COMPONENTS

Packing Configurations

There are several shipping containers configurations used for each required shipping temperature and container design. Centers may use all or only certain types of containers for transport. Containers have been validated for the transport times listed in the following table.

Temp.
Component Type
Coolant
Container Designation
Transport Time
1-10C
Red Cells/ Whole Blood
BSI Blue Ice
CF45 /CF89/ Igloo Coolers
< 48 hours/ < 3 hours
20-24C
Platelets/ Granulocytes
Gel Coolant
Igloo Coolers/ EU-38
< 3 hours/
< 24 hours
< -20C
Plasma/Cryoprecipitate
Dry Ice
CF45/ CF89
Dependent on amount of dry ice. Shipment is acceptable if dry ice is still present.

A packing slip will accompany each shipment.

To return components to BCP, they must be packed in the shipping container with appropriate coolant determined for the type of product. If you have any questions concerning packing units for return, contact the Hospital Services department at you blood center.

The CF-45 and CF-89 shipping containers may be used for temporary storage of blood products in the case of a storage unit failure. Proper packing and temperature measurement and recording every 4 hours is required. Contact Hospital Services to arrange to return units, when applicable, or provide adequate shipping containers and packing materials for short term storage.

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Packing Supplies and Configuration for Returning Red Cells to BCP

Packing supplies are available from BCP RBCs may be returned to BCP when the following packing configuration is followed:

  • BSI Blue Ice: Do not store at temperatures colder than -35C. If stored at <-20C, leave ice at ambient room temperature for at least 15 minutes prior to packing. Ensure BSI Blue Ice is frozen solid prior to packing shipping container.
  • Polar Packs (8 oz): Equilibrate to a temperature of 1-6C for red cells/whole blood.
  • Plastic Bags (4 mil)
  • Absorbent Pads
  • CF-45/CF-89 Shipping Container with polyurethane liners

1. Place plastic bag inside inner box.

a. The CF-45 holds one inner box, the CF-89 holds two. b. If the CF-89 container is used, ensure both inner boxes are packed appropriately.

2. Place one frozen solid BSI Blue Ice on each end of the cardboard sleeve, positioned between the sleeve and the inner box wall.

3. Place one absorbent pad flat inside plastic bag.

4. Place 2 units on top of the absorbent pad.

5. Repeat layering of absorbent pads and units until the box is full, ending with absorbent pad.

a. Caution: Minimum component load is 1200 mL. Add refrigerated Polar Packs to bring the total component load to at least 1200mL.
b. If Polar Packs are used to add volume, treat them as units and layer as described above.

6. Close and secure plastic bag.

7. Insert top polyurethane panel.

8. Close and seal container.

9. Ship to BCP to ensure container is received within 48 hours.

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Packing Supplies and Configuration for Returning Platelets to BCP

Packing supplies are available from BCP Platelets may be returned to BCP when allowed by the Service Agreement and the following packing configuration is followed:

  • Polar Packs (48oz): Equilibrate to a temperature of 20-24C for platelets.
  • Plastic Bags (4 mil)
  • Absorbent Pads
  • E-38UB Shipping Container with polyurethane liners

1. Place plastic bag inside inner box.

2. Place two polar packs (flat) inside the plastic bag.

3. Place two absorbent pads flat on top of polar packs.

4. Place unit(s) on top of the absorbent pads.

5. Repeat layering of absorbent pads and units until the box is full, ending with absorbent pad.

6. Close and secure plastic bag.

7. Insert top foam panel.

8. Close and seal container.

9. Ship to BCP to ensure container is received within 24 hours.

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Couriers

BCP supplies couriers for transfusion facilities within driving distance (determined by blood center distribution locations).

Schedule of routine runs is dependent on the Transfusion Facility. Other couriers not currently in contract may be used in certain situations.

Discuss these options with your blood center.

Couriers may facilitate transfer of components between Transfusion Facilities.


Other Delivery Mechanisms

Out of town delivery depends on the location of the Transfusion Facility. Contact Hospital Services for specific details.

Receipt of Shipments Using non-BCP Couriers

 

When a shipment is delivered by a non-BCP courier, evaluate appropriate packing configuration and temperature for type of component. Contact the Hospital Services department at your blood center if you have any questions concerning deviations or questionable storage conditions.

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RETURN OF COMPONENTS

Return Privileges for Credit

Returning short-dated units for use by another facility benefits everyone; ensuring an adequate blood supply is everyone's responsibility. Return privileges are defined in the Agreement, Units must be properly packed in appropriate shipping containers for return, and red cells must have a minimum of 2 segments remaining on the unit. Units must have been stored at the Transfusion Facility following required storage conditions, and monitored during the storage period. Your BCP center will conduct visits to your facility to ensure acceptable storage is maintained (see section on Facility Inspection and Shipping Quality Control).

Units Returned for Quality Issues

Units that are returned for quality issues or at the request of BCP are automatically credited.

Hospital Services may request return of a component for several reasons (e.g., recall, market withdrawal, positive bacterial detection of a platelet, shortage of a particular blood type at another facility). In some cases, BCP will request destruction of the unit on site if not transfused, and will provide credit if this is done.

Units of questionable quality identified at the transfusion facility are returned to BCP for evaluation. Contact Hospital Services to report the specific situation.

Required Documentation

Complete applicable sections of the Return Document form for a unit returned to BCP. This form is also completed when transferring a unit to another Transfusion Facility.

Complete applicable sections of the Return form for requesting credit for a unit disposed of at the Transfusion Facility.

(Contact Hospital Services for return forms.)

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BLOOD COMPONENT STORAGE & HANDLING

Requirements

As stated in the Agreement , the Transfusion Facility furnishes specific storage units, restricted to storage of blood and other biologicals, capable of maintaining required storage temperatures as specified in Title 21 of the Code of Federal Regulations, Standards of the AABB and BSI policies and procedures.

Normal Storage and Temperature Monitoring

Storage units must be equipped with a continuous temperature monitoring system that records temperatures at least once every four hours and an alarm that sounds if temperature limits are reached. The facility verifies continuous blood storage temperature of the storage units and maintains such documentation. The facility notifies Blood Centers of the Pacific of any temperature deficiencies in the storage of blood and blood components within 24 hours of the occurrence and agrees not to return units subjected to temperatures outside the required ranges unless approved for return by BCP. Documentation of storage temperatures may be required during inspections by regulatory agencies, and the facility agrees to provide records to BCP upon request.

Requirements for blood storage units are:

Component
Storage Temperature
Whole Blood, Red Blood Cells
1-6C
Plasma, Cryoprecipitated AHF
-18C or colder
Platelets
20-24C, with gentle agitation
Granulocytes
20-24C, without agitation

Additional criteria for storage and handling:

  • Blood and blood products must be stored in labeled designated storage areas/units.
  • Alarm checks of storage units must be performed and adequate corrective action taken when indicated.
  • When released to another department, blood components must be maintained within appropriate storage temperatures or returned to proper storage within a specified time if storage is not available and the component is not transfused.
  • Store in an orderly fashion to prevent crowding and allow air circulation.
  • Do not store quarantined components above other components.
  • Do not store reagents above blood components.
  • Segregate autologous components from allogeneic components, and biohazard labeled autologous components from other autologous components.
  • Do not overlap platelet bags during storage, and place face down to optimize oxygen exchange.

Storage Unit Failures

In the event of a storage unit failure, components must be moved to appropriate alternative storage. If alternative storage is not available with a temperature monitoring system, temperatures must be manually checked and recorded a minimum of every 4 hours. Alternative storage may be temporary storage of components in BCP shipping containers. Contact Hospital Services to discuss alternative storage at BCP or using BCP shipping containers.

DERIVATIVES AND REAGENTS

Available from BioCARE:

  • Albumin
  • Coagulants
  • Fibrin Sealant
  • Hyper Immune Globulin
  • IM Immune Globulin
  • IV Immune Globulin
  • Rh Immune Globulin
  • Blood Banking Reagents

Refer to the Blood Components and Derivatives section of this Handbook for information relating to commonly ordered derivatives.

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BILLING PROCESSES

Blood center component service (processing) fees should be listed on patients' bills separately from hospital blood related charges.

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FACILITY INSPECTION & SHIPPING QUALITY CONTROL

Upon request by the FDA, CAP, AABB or BCP, its agents and employees, the transfusion facility shall allow reasonable on-site inspection of blood storage facilities during normal business hours. They shall also allow the review and copying of the storage facility's SOP for blood component storage and quality assurance records relating to blood component storage and handling.

Inspection of storage records is performed by BCP on an annual basis, unless the facility has current AABB certification and two consecutive years of satisfactory inspections. In these cases, the inspection is performed every two years. Results of the inspection are shared with the transfusion facility.

During the inspection, BCP employees will complete an inspection checklist when observing storage devices. There is one checklist for each temperature range:

  • Storage at 20-24C: BS 983A
  • Storage at 1-6C: BS 983B
  • Storage at or colder than -18C: BS 983C

Twice a year (summer and winter), BCP staff perform temperature quality control on units shipped to selected facilities. The facility should follow instructions on the Datalogger Envelope, BS 334G, and return the shipment to BCP by overnight delivery as soon as possible if delivered by a non- BCP courier. (Contact Hospital Services for a Datalogger Envelope BS 334G.)

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