Blood and Blood Products Redistribution Program for Ontario Transfusion Services

(An addition to the Inventory Management Toolkit)

Table of Contents

Section 1: Introduction

Purpose and Rationale:

Section 2: Getting Started

1.Reviewing Inventory Stock:

2.Reviewing Hospital Courier System:

3.Creating a Memorandum of Understanding:

4.Creating/Revising Current Procedures for Redistribution of Blood Products:

5.Training:

Section 3: Implementation

1.Piloting the process:

2.Equipment annual validation:

Section 4 - Templates

Template 1: Memorandum of Understanding

Template 2: Standard Operating Procedure

Template 3: Form FA - Materials/Devices Pre-Conditioning Log

Template 4: Form FB - Prior Notification of Blood Product Redistribution

Template 5: Form FC - Transfer Schedule for Redistribution

Template 6: Form FD - Inter-Hospital Transfer Form

Template 7: Form FE - Courier Log Sheet

Template 8: Packing of Blood Product for Redistribution Training Checklist: Initial TrainingReceiving Site

Template 9: Packing of Blood Products for Redistribution Training Checklist: Initial Training Shipping Site

Template 10: Redistribution Competency Training Quiz

Regional Blood and Blood Product Redistribution Program for Ontario Transfusion Services

Section 1: Introduction

This document is an addition to the Inventory/Utilization Management Toolkit already available on the website. This document is designed to aid Transfusion Medicine Services in the successful management of blood and blood products while at the same time ensuring compliance with existing practice standards for Ontario hospitals.

Purpose and Rationale:

The purpose of theredistribution process is to reduce the overall number of productsthat outdate at the hospitals.

The Ontario Regional Blood Coordinating Network (ORBCoN) has worked with other Provincial Blood Offices to validate shipping containers and inter-hospital exchange procedures in order to conserve resources and avoid duplication of effort. These blood offices include: British Columbia, Manitoba, Nova Scotia and Newfoundland. The Northern and Eastern region of ORBCoN took the lead to pilot the red cell redistribution process while the Southwest region of Ontario took the lead to pilot the platelet redistribution process for Ontario. A field validation of the selected shipping container with accompanying procedures was performed in partnership with the Timmins Cluster of hospitals and Hamilton Health Sciences.

In order to implement this process, standardized procedures are needed to ensure that the security and safety of the blood products are maintained and that the process is validated to demonstrate this.

ORBCoN was advised that shipping containers currently used by Canadian Blood Services (CBS) were not to be used by hospitals for redistribution.CBS expressed concerns over liability if products were not packed by CBS personnel but were delivered in a shipping container identified as being fromCBS. For this reason, it was necessary to find an appropriate shipping container that could be validated and used by hospitals in the redistribution program.

Conclusion:

A validated shipping container, procedures and training package are provided for hospitals to use in implementing a blood and blood product redistribution program in their area. It is recommended that a field validation be performed for each program to ensure variations in transport and personnel are tested.

Section 2: Getting Started

  1. Reviewing Inventory Stock:
    When designing a redistribution program, the transfusion service must first look at the current daily inventory of each product at each facility that will be involved with redistribution. Consideration must be given to the number of transfusions/infusion each facility performs per year, the existing outdate rate, storage equipment, and standing orders from the blood supplier. It is recommended that you refer to the information found in the Inventory Management Toolkit under Blood Component Inventory – How much is enough? How much is too much? (Page 6), when reviewing the inventory stock levels.
  2. Reviewing Hospital Courier System:
    For hospitals that are part of a corporation or consolidated organization, established courier systems can be utilized to support the redistribution of products. Consider the transportation of referred testing samples to sites within the group of hospitals. There are often couriers transporting documentation and supplies to sites within the group that could include the pick up these shipping containers and transport them to a hospital on the route.
    If there is no courier system established for a group of hospitals that are considering redistribution, the cost of the courier could be shared by the group of hospitals. If a hospital has to ship blood for redistribution more than once per week, then it is recommended that the inventory of that particular hospital be reassessed to see if adjustments are necessary.
  3. Creating a Memorandum of Understanding:
    Some organizations will opt to develop a memorandum of understanding (MOU). This is a useful tool toidentify and document responsibilities for each partner in the program. An example of a MOU template is provided in this package as appendix 1, to help facilities get started with establishing an agreement.
  1. Creating/Revising Current Procedures for Redistribution of Blood Products:
    With the implementation of a new shipping container, procedures have to be revised to incorporate the steps required to use the container. These procedures and policies must be drafted and approved by the Medical Director of each site,thentestedto validatethe security, safety and reliability of the program and products being redistributed. Once the boxes have been placed into use, it is recommended that a periodic audit be conducted in both cold and hot weather seasons to verify the boxes performance. An example of a procedure template is provided in this package to help develop a standard set of work instructions that can be incorporated into existing or newly developedprocedures.
  1. Training:
    Implementing a new process must include training staff that will be directly involved with the process. Training can be in the form of a competency evaluation or by exposure. Competency evaluation is a means for instructors or teachers to determine the learner’s ability to perform to an expected standard. Exposure training can be usedfor a learner who requires an overview for knowledge purposes only. (This type of training would be for those who would not be performing the new process but should still have the knowledge of what is expected from the process.)
    For the purposes of a redistribution program, staff who will be involved with packing units for shipment, or receipt of redistributed units should be considered for competency evaluation. A simple training video demonstrating the steps for packing units for redistribution can be used along with live demonstrations. Following the demonstrationthe learner should performthe steps as outlined in the accepted procedure with a trainer. A template of competency evaluation questions is provided as part of the training package developed for theRegional Blood Product Redistribution Program for Ontario Transfusion Services. Alwaysfollow your facility’s requirements for documentation of training.

Section 3: Implementation

  1. Piloting the process:
    It is recommended that each facility pilot the process of redistribution for a specified period of time as determined by the Medical Directors of each piloting site. This period should be used to test the established procedures, logistics set up for transport, and track any incidents or errors that arise that can be linked to the redistribution process or the redistributed products. Once the pilot has demonstrated acceptable results, the process can be fully implemented. Review of the inventory and rate of outdating of red blood cells prior to and after implementation is also recommended to determine the impact of redistributionfor the shipping sites as well as the receiving sites.

2.Equipment annual validation:

Replacement of Vacuum Insulated Panels (VIP) is recommended every 36 months after the stated production date, which is provided on the outside of the VIP.

Annual recertification of the transport box is also recommended. Data loggers can be purchased to aid in the certification of temperature inside the transport box during shipment with RBC payload. Contact your ORBCoN regional field officer for purchase information on the VIP or data logging tags and software.

Section 4 - Templates

Template 1

Regional Red Blood Cell Redistribution Program for Ontario Transfusion Services

Memorandum of Understanding

Between

(List institutions of the group)

And

<ENTER HOSPITAL OR TRANSFUSION SERVICES>

For

Redistribution of Blood Products within the

ENTER GROUP NAME

PURPOSE

The purpose of this Agreement is to establish cooperation in the venture of planning, validating, and implementing a redistribution program of near outdating blood products to reduce the number of discards.

The target to achieve and maintain for total outdating wastage rates will beenter target in % and whole number or less for the enter group name> of Hospitals utilizing blood products received from the Canadian Blood Services.

GOALS and FORMS of COOPERATION

The main interests of this partnership are as follows:

  • Develop institutional basis for cooperation and exchanges.
  • Redistribute near outdating blood products to a site with a higher probability of utilization.
  • Develop a plan for sustainability of this project following the funding period designated by the governmental agencies involved.

COORDINATION

The technical and administrative coordination of this Agreement is appointed to the lead institutions <enter main program lead>.

The technical and administrative coordination shall address and resolve logistical and administrative issues that may arise during the term of this Agreement, and shall supervise and report on the activities conducted within the framework hereof.

CLAUSE

  1. Definitions

Sending Institution: shall mean the institution which shipsthe near to expireblood product to the receiving institution

Receiving Institution: shall mean the institution that has agreed to receive the near to expire blood product from the sending institution

Nearly Expired blood product: shall mean that any product shipped can not have less than Insert acceptable timeframe of productremaining of the shelf life.

Administrative Co-coordinator: shall mean the institutional representative designated to fulfill the administrative responsibilities of the co-ordination of this Memorandum of Understanding in each participating institution (list coordinators’ names, addresses, e-mails and telephone numbers).

Name / Institution / Address/Telephone / Email

B.Procedure Development

Identify responsibilities for creating, revising, updatingand approving current procedures for redistribution of blood products.

C.Implementation

Roles and Responsibilities of participating institution members

Sending Institution: <Identify sending sites responsibilities

Receiving Institution: <Identify receiving sites responsibilities

General Responsibility: (All Parties)

  • To the extent possible, the participating institutions will ensure that blood components are handled, stored, distributed and transported in a manner that prevents damage, limits deterioration, and meets requirement standards.

(Refer to, CSA CAN/CSA-Z902-10 Blood and Blood Components, CSTM Standards for Hospital Transfusion Services Version 2 September 2007, Ontario Laboratory Accreditation (OLA) Version 4.1 July 2008,

Enter other responsibilities agreed by the participating institution members

D. Fees and Financial Support

  • The provincial government has agreed to provide starter boxes to each hospital site that is part of a redistribution program. Each site will receive boxes initially through the Ontario Regional Blood Coordinating Network (ORBCoN). Each facility will be responsible for funding replacement material for purposes of redistribution once the starter materials have become outdated, non-useable, or if misplaced.
  • Enter agreement for purchasing replacement boxes for group
  • Enter agreement for assigning/purchasing replacement data logging software if being used by group
  • Enter agreement for funding support for courier services to support the redistribution program

IN WITNESS WHEREOF, each of the undersigned parties represents and warrants that it has the full authority to sign and enter into this agreement on behalf of the institution that each purports to represent.

SIGNATORIES

[Enter Hospital] [Enter Hospital]

______Date: ______Date: _____

Title______Title______

Template 2: Standard Operating ProcedurePage: 1 of

Manual

/ Standard Work Instruction Manual /

PROCEDURE

Section / Inventory Management
Title: Redistribution of Blood and Blood Products Using the MTS Shipping Containers
Issued by / Ontario Regional Blood Coordinating Network / ID:
Approved by / Project Sponsor
Effective Date
Revised Date / YYMMDD
YYMMDD / Version: / File Name:
Controlled document. Any documents appearing in paper form must be used for reference purposes only. The on-line copy on the file server above must be considered the current documentation.

1.0 Principle:

1.1.Most blood products are ordered directly by hospitals from Canadian Blood Services. Hospitals however, have the option of transferring blood and blood products between facilities for optimal utilization. In such cases, it is necessary to ensure that the blood products are properly packaged to maintain an acceptable temperature range during transportation, and the process ensures accurate tracking and disposition reporting.

1.2.The Minnesota Thermal Science (MTS) shipping container provided by the Ministry of Health and Long Term Care for redistribution of blood and blood products uses “Phase Change” material to maintain acceptable temperature for a specified period of time. Phase Change Material (PCMs) has a high rate of heat fusion, which allows it to absorb and release energy depending on the ambient temperature surrounding it. When the temperature becomes warmer, the PCM liquefies and absorbs heat energy and stores it. When the temperature begins to fall the PCM begins to solidify and releases stored heat energy.

2.0 Purpose:

2.1.To provide a uniform process for redistributing blood components and plasma protein products to external sites.

2.2.To ensure that the acceptable temperature range is maintained during transportation.

2.3.To provide a uniform process for tracking redistributed blood components and plasma protein products.

3.0 Scope and Related Policies:

3.1.Shipped blood components and plasma protein products for the purpose of redistribution must be accompanied by IM.006FB – Inter-hospital Transfer of Blood/Products.

3.2.All blood components and plasma protein products shall be inspected for abnormal appearance immediately before packing for transportation. This inspection must be documented.9.1

3.4.Blood components and plasma protein products shall be transported in a manner that will maintain the storage temperature requirements specified by the supplier in a validated shipping container.9.1, 9.5

3.5.A record of the storage temperature of the products must be available on request at the facility that shipped the product.

3.6.Discontinuation of agitation of platelets during transportation should not exceed 24 hours.9.1

3.7.Shipping containers for blood components and plasma protein products must be constructed to resist damage and be designed to include a temper evident seal.9.1

3.8.All shipments of blood components and plasma protein products must include documentation that has the following information:

  • Name of shipping facility and receiving facility
  • Identification of components/products shipped (unit numbers/lot numbers) and description of component/product and total number of units shipped
  • Date and time shipped
  • Identification of person who packed shipment must be documented
  • Shipping document has a unique number to allow for tracability9.1

4.0 Materials:

4.1.EQUIPMENT

If Redistributing / Then Use
Products shipping temperature is between
1 -10ºC /
MTS CREDO EMT SHIPPING CONTAINER
MTS Redistribution Box
(22-24ºC) /
MTS CREDO CUBE SHIPPING CONTAINER

4.2.Supplies

Plastic bag (optional) Security seal (Plastic tie wrap)

Clean crumple paperTransfer of Blood Products Form (IM.006FB)

Address labelWay bill (if required)

5.0 QUALITY CONTROL

5.1.Red blood cells, platelets, frozen plasma/cryoprecipitate and plasma protein products shall be packed in separate shipping containers for redistribution.

5.2.Annual validation of the shipping container shall be done to re-confirm that temperatures remain consistent within acceptable temperature range.

5.3.Temperature checks upon receipt can be performed if required by facility.

5.4.Shipping containers must be inspected before and after each use.
Check that:

The inner container is clean

The straps and buckles are in good condition

The outer container is free of breaks/rips and of conflicting address labels

5.5.The required shipping temperatures for blood components and plasma products are as follows:

PRODUCT / TEMPERATURE
Red Blood Cell Units / 1 – 10 ºC
Platelets / 20- 24 ºC
Plasma Protein Products / Consult product insert

6.0 PROCEDURE

Procedure Steps / Work Instructions
6.1.Pre-condition Thermal Insulated Chamber or Panels / Container / Shipping Environment Temperature / Pre-Condition Temperature/Time
MTS EMT / >4º C / -18 to -40ºC
For minimum of 8 hrs
≤4ºC / 4 -6ºC
For minimum of 6 hrs
* pre-conditioned units/panels can be stored in
MTS Credo Cube / Warm ambient / 20 - 21ºC
For minimum of 12 hrs
Cold ambient / 23 -24ºC
For minimum of 12 hrs
6.1.1.Pre-condition the thermal insulated chamber or panels according to table below.
6.1.2.Document the pre-conditioning temperatures on form IM006FA
6.2.Inform Receiving Site / 6.2.1.Inform receiving site by phone one day prior to shipping date the number of units that will be shipped.
6.2.2.Do not ship “near to expire” products to the receiving site if so doing will decrease your inventory below minimum acceptable levels. If maintenance of minimum inventory depends on the arrival of products from the blood supplier, do not ship your “near to expire” products until the new shipment has be received from the blood supplier.
6.3.Retrieve shipping container / 6.3.2.Determine the required shipping container to be used. Refer to section 4.0.
6.3.3.Retrieve shipping container and all required supplies for selected shipping container.
If using MTS EMT container then:
6.3.4.Document number found on TIC lid/base in section A of Form IM006FB. (if applicable)

6.3.5.Place the Thermal Insulated Chamber inside the VIP container.
If using MTS Credo Cube then:
6.3.6.Assemble Thermal Insulated Panels by adding one panel to the bottom of the VIP container with the credo logo facing up.
6.3.7.Place 4 panels on each of the sides of the VIP with the logo facing up. Once the products are inside the panels, the top panel can be place over top of the products and inside panels.

6.4.Inspect container and supplies / 6.4.1.Ensure the Velcro straps are in good condition.
6.4.2.Ensure the outer container is free of rips/breaks and conflicting address label.
6.4.3.Ensure the inside Thermal Insulated chamber or panels are free of ice, water or other debris.
6.4.4.
If / Then
Preconditioning chamber or panels in freezer / Before adding products let stand at room temperature for 30 min or until surface frost has dissipated
Preconditioning chamber or panels in fridge / Before adding products verify the phase change material is liquid by gentle shaking
Preconditioning panels in room temperature environment / Remove and begin to assemble
6.5.Retrieve products intended for redistribution / 6.5.1.Remove identified products for redistribution from fridge or incubator.
6.5.2.Complete section B of Form IM006FB.
6.6.Pack components / 6.6.1.Pack products within 20 min of schedule courier pick up.
6.6.2.Place components in plastic bag. (if applicable)
6.6.3.Follow packing method described below.
For MTS EMT container: Up to 4 RBC units per container

For CREDO Cube container: Up to 4 Plt units per container

6.6.4.Place temperature monitoring device where applicable inside the container prior to closing. (If applicable)
6.6.5.Insert tamper proof indicator on container.
6.7.Review documentation / 6.7.1.Review form IM006FB for accuracy and completion of all required information.
6.7.2.Copy the completed Form IM006FB. Retain the copy in laboratory for specified amount of time according to documents and records retention policy.
6.7.3.Fold and place original form IM006FB in pouch located on the top of the shipping container.
6.8.Label container / 6.8.1.Choose the correct address label to be used.
6.8.2.Place label in pouch found on the top of the shipping container.
6.8.3.Ensure the correct “Return” address is found on the back of the “Ship to” address label.
6.8.4.Complete courier way bill. (if applicable)
6.9.Prepare for courier pick up / 6.9.1.Place shipping container with completed documents where courier can retrieve easily.
6.9.2.Document time of courier pick up on facility generated log sheet. (if applicable)
6.10.Receiving shipping container with products / 5.10.1.Receive shipping containers from courier as per facility policy.
5.10.2.Retrieve documents from shipping container pouch located on the top of container.
5.10.3.Follow established facility protocol for receiving products into inventory.
5.10.4.Complete section C of Form IM006FB.
5.10.5.File Form IM006 as per facility established document and records retention policy.
5.10.6.Prepare the empty shipping container for shipment back to originator by placing the “return to” label in pouch facing up and place for courier pick up in designated pick up area.

7.0 Procedure Notes: