STANDARD OPERATING PROCEDURE FOR INTER-HOSPITAL TRANSFER OF RED BLOOD CELLS WITHIN THE PROVINCE OF NEWFOUNDLAND AND LABRADOR

USING THE GOLDEN HOUR 24 / 2 SHIPPING CONTAINER

Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

TITLE:

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells within the Province of Newfoundland and Labrador using the Golden Hour 24/2 Shipping Container. To describe the procedure for packing and shipping red blood cells from one hospital/region to another hospital/region within the province of Newfoundland and Labrador.

PURPOSE:

1.0

Prerequisites 1.1 Monitored temperature controlled refrigerator 1.2 1.3 Monitored temperature controlled freezer Canadian Society for Transfusion Medicine, Standards for Hospital Transfusion Services, Version 2, Ottawa, ON: Canadian Society for Transfusion Medicine, September, 2007 Canadian Standards Association Standards for Blood and Blood Components, Z902-10, Canadian Standards Association, 2010 Facility Policies and Procedures for the Storage of Red Blood Cells Temperature Records for the Storage Equipment Documentation of Training for the Interhospital Transfer of Red Blood Cells.

1.4

1.5 1.6 1.7 2.0

Equipment and Supplies 2.1 Golden Hour 24/2 Shipping Container 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 Plastic shipping bag with ties Security or tamperproof device Interhospital Transfer Form, IHT-NL001 or Meditech Equivalent Interhospital Transfer Notification Form, IHT-NL002 or hospital equivalent Courier Log Sheet, IHT-NL003, where applicable Address/Shipping Label, IHT-NL004 or hospital equivalent Pre-Conditioning of Shipping Container Form, IHT-NL005 Log Tag (Temperature Monitoring Device), Log Tag Interface and software Red Blood Cells (RBCs)

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

3.0

Policy Statements 3.1 All red blood cells shall be shipped in such a manner that the red blood cells are maintained within specified conditions at all times. Transported red blood cells with a required storage temperature of 1-60C shall be maintained at a temperature of 1-100C. Transportation time shall not exceed the validated limits (24 hours) of the shipping container.

3.2

3.3

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

4.0

Process Flowchart 4.1 Shipping Site Process Flow

Retrieve Transfer schedule Pre-condition shipping container Select units and forms Initiate documentation Inspect red blood cells Document inspection

Inspect shipping containers Pack red blood cells with Log Tag Complete Documentation Place address label and tamper proof device on shipping container Transfer shipping container to shipping department

Notify receiving hospital

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

4.2

Receiving Site Process Flow

Retrieve Fax Notification Receive incoming Shipping Container Inspect shipping containers Document Receipt Information on form Remove Log Tag and download data Inspect red blood cells upon receipt Document inspection

YES Was temperature acceptable upon receipt?

Place red blood cells in inventory

Complete Documentation NO Quarantine red blood cells for destruction as per lab policy

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

5.0

Transfer Schedule 5.1 A transfer schedule shall be developed by each region that identifies the shipping site, receiving site and date for transfer of red blood cells. 5.2 The transfer schedule must be followed to ensure that the same red blood cells are not shipped repeatedly. If you are unable to ship at the designated time, notify the receiving site so that the receiving sites inventory is not negatively impacted. Obtain the forecasted outside temperature for the transit time of the shipment if shipping by air. Determine the temperature of the courier van or bus prior to initiating transfer of red blood cells. In most cases, the temperature of the courier may be greater than 4C in both summer and winter seasons. Therefore the summer profile would be used.

5.3

5.4

5.5

6.0

Pre-condition shipping container 6.1 General Information: 6.1.1 The shipping container consists of the following components: 6.1.1.1 Thermal isolation chamber (TIC) or black box (includes lid). 6.1.1.2 Vacuum insulated panels (VIP) or insulated panels. 6.1.1.3 Corrugated cardboard sleeve (CCS) or cardboard box. 6.1.2 The insulated panels fit into the cardboard box; referred to as the insulated shipping container. The black box fits into the insulated shipping container after preconditioning. It is recommended that the insulated shipping containers and black boxes be given a unique identification number. Obtain the forecasted ambient temperature by accessing a weather forecasting centre such as the Environment Canada at:
http://www.weatheroffice.gc.ca/forecast/canada/index_e.html?id=NL

6.1.3

6.1.4

6.1.5

Precondition the black box prior to shipping as stated in 6.2.

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

6.1.6

Obtain the Pre-Conditioning of Shipping Container form. A copy of the form should be placed on the door of the refrigerator and freezer used to pre-condition the black boxes. Document on the Pre-Conditioning of Shipping Container form the black box number, the date and time the box was placed in the unit, document initials. Document the date and time the black box was removed from the unit. Perform a visual inspection of the black box upon removing from the unit to ensure there are no cracks or leaks. Document the results of the inspection. Document initials.

6.1.7

6.1.8

6.2

Preconditioning Requirements: 6.2.1 WINTER PROFILE: For shipments where the ambient 0 temperature is less than 4 C, the following preconditioning requirements must be met: 6.2.1.1 Stabilize the black box at 5-8 0C for a minimum of six hours. 6.2.1.2 Before using, ensure internal refrigerant is liquid by shaking. (Note: If the refrigerant is partially frozen, the shipment time is significantly reduced and the shipping temperature may not be acceptable. There is no need to allow the black box to stand at room temperature.) 6.2.2 SUMMER PROFILE: For shipments where the ambient 0 temperature is +4 C or greater, the following preconditioning requirements must be met: 6.2.2.1 Stabilize the black box in a freezer (temperature range between -180C and -400C) for a minimum of 8 hours until frozen hard. 6.2.2.2 Remove black box from freezer and allow to rest at room temperature for thirty (30) minutes, until surface frost melts. Do not place lid flat to rest.

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

7.0

Select Units and Forms 7.1 Select the red blood cells designated for transfer. Select a maximum of four (4) units for each shipping container. Ensure there is a minimum of 10 days remaining on the unit of red blood cells prior to the expiry date. Obtain the Interhospital Transfer Form or Meditech equivalent approved transfer form that incorporates required information. The Interhospital transfer form will be referenced throughout this document. Initiate documentation on the Interhospital Transfer Form, Section I.

7.2

7.3

7.4 8.0

Inspect Red Blood Cells 8.1 Red Blood cells must be inspected immediately before packing and upon receipt. 8.2 Visually inspect red blood cells for the following: 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 Contamination red blood cells may appear purple or black in color Discolouration inspect supernatant or plasma for discolouration. Leakage ensure the segments and the container is not leaking. Expiry Date ensure the unit has not reached its expiry date. Ensure a minimum of four segments are attached to the unit. Mix the units and observe for large clots. Do not ship if large clots are found. Compare the color or the red blood cells in the segments with the red blood cells in the container, ensuring the color is the same. Ensure all ports are intact and that none of the ports are missing.

8.2.7

8.2.8 8.3

Red blood cells that do not pass visual inspection must be quarantined for discard and the action documented. Do not ship red blood cells that have been modified by the hospital.

8.4

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

9.0

Procedure for Shipping Site 9.1 Confirm the ambient temperature immediately prior to packing the red blood cells by accessing a weather forecasting centre such as Environment Canada at: http://www.weatheroffice.gc.ca/forecast/canada/index_e.html?id=NL Ensure the black box has been pre-conditioned for the appropriate shipping profile. Inspect the shipping container for the following: 9.3.1 Inspect the cardboard box for worn or torn cardboard outer layer. Replace worn cardboard boxes when necessary. Inspect the insulated panels to ensure the vacuum is maintained. Inspect the black box and lid to ensure there are no cracks or leaks. Do not use containers that are leaking. Inspect the Velcro strap and ensure that it is still effective to close the black box.

9.2

9.3

9.3.2 9.3.3

9.3.4

9.4 9.5 9.6

Obtain units of red blood cells that have been stored at 1-60C. Inspect unit(s) of red blood cells as per Section 8.0. Document that the inspection has been performed on the Interhospital Transfer Form in Section I. Document total number of unit(s) shipped on the Interhospital Transfer form in Section I. Place a maximum of four (4) units in a plastic bag and fold over plastic bag. Press START on the Log Tag. Place Log Tag temperature monitoring device outside the bag, within the folds of the bag. Do not place Log Tag in direct contact with the units. Do not place Log Tag in direct contact with the shipping container. Place the units in the shipping container.

9.7

9.8 9.9

9.10

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

9.11 9.12 9.13 9.14

Close the black box by placing the lid on top of the container. Secure the lid tightly in place using the Velcro straps. Place the black box into the insulated shipping container. Complete Section II of the Interhospital Transfer form. The shipping time (24 hours maximum) is measured from the time the container is closed. Copy the Interhospital Transfer form and retain copy at shipping site. Place original Interhospital Transfer Form on top of the insulated shipping container. Close the cardboard box. Remove old shipping/address labels attached to shipping container, if present. Secure with tamperproof device where indicated on the cardboard box. Affix the shipping label to the shipping container. 9.20.1 The shipping label must include the following information: a) b) c) d) The shipping site address The receiving site address A statement that it contains human blood components Any caution or description required under provincial or federal transport regulations

9.15 9.16

9.17 9.18

9.19 9.20

9.21

Place packed shipping container in courier pick up area for delivery. Complete Courier Log Sheet if applicable.

10.0 Notification to Receiving Site 10.1 The shipping site is responsible to notify the receiving site by phone and fax, when sending a shipment Obtain the Interhospital Transfer Notification form. Complete the applicable information. Phone the receiving site with the shipping details.

10.2 10.3 10.4

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

10.5 10.6

Fax completed form to designated receiving site. Attach fax confirmation to Interhospital Transfer Notification form and the hospital copy of the Interhospital Transfer Form.

11.0 Procedure for Receiving Site 11.1 11.2 11.3 Retrieve the fax notification of Interhospital Transfer. Receive incoming shipping container. Inspect shipping container for the following: 11.3.1 Inspect the shipping container for worn or torn cardboard outer layer. 11.3.2 Ensure tamperproof device is intact. 11.4 11.5 Remove Interhospital Transfer Form from shipping container. Complete applicable documentation in Section I and Section III on the Interhospital Transfer Form. Remove Log Tag from the folds of the plastic bag and press the START button. (This places a marker on the data.) Place Log Tag in Log Tag interface cradle to download data from Log Tag. Print data and attach to Interhospital Transfer form. Remove units of red blood cells from the plastic bag.

11.6

11.7 11.8 11.9

11.10 Confirm documentation on the Interhospital Transfer form matches the labelling on the unit(s) of red blood cells. 11.11 Ensure that the total number of units shipped is the same as that indicated on the Interhospital Transfer form. 11.12 Perform the visual inspection upon receipt of the red blood cells as per Section 8.0. 11.13 Document in the applicable columns, the results of the visual inspection and initials in Section I on the Interhospital Transfer form.

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

11.14 Review downloaded data chart to determine if the temperature during shipment was within the acceptable temperature range of 1 to 100C. 11.14.1 If temperature was not acceptable, place red blood cells in quarantine for destruction following facility protocols. 11.15 Document temperature upon receipt and time in transit in Section III on the Interhospital Transfer Form. 11.16 Place the units of red blood cells into general inventory for use following the transfusion service policies and procedures. 11.17 Review all documentation for completeness. Failure to complete the required documentation may result in the products being discarded according to hospital policy.

12.0 Records Management 12.1 The shipping site must keep a copy of the Interhospital Transfer form (release vouchers) indefinitely. 12.2 The receiving site must keep the original of the Interhospital Transfer form indefinitely. Temperature monitoring records for blood products must be kept a minimum of five years. Records of blood components inspection prior to release must be kept for a minimum of five years. Documentation of staff training and competency must be kept for a minimum of ten years.

12.3

12.4

12.5

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Provincial Blood Coordinating Program

Standard Operating Procedure for Inter-Hospital Transfer of Red Blood Cells

13.0 References 13.1 American Association of Blood Banks. Standards for blood bank and transfusion services, 26th ed. Bethesda, Maryland: American Association of Blood Banks; 2009 13.2 Becher M. Technical manual. 15th ed. Bethesda, Maryland: American Association of Blood Banks; 2005. 13.3 Canadian Standards Association. Blood and blood components Z902-10. Mississauga (ON): Canadian Standards Association; 2010. 13.4 Canadian Standards for Transfusion Medicine. CSTM standards for hospital transfusion services Version 2.0. Ottawa: Canadian Society for Transfusion Medicine; 2007. 13.5 Provincial Blood Coordinating Office. British Columbia provincial blood coordinating program interregional blood redistribution resource manual. Vancouver (BC): Provincial Blood Coordinating Office; Jan.2005.

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