Canadian Guidelines for the Uniform Labelling of Blood and Blood Components Using ISBT 128

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1. Preface

This document delineates the Canadian guidelines for the labelling of blood and blood components using ISBT 128. It is intended to provide necessary information to assist in using ISBT 128 in Canada.

Labelling of blood and blood components by blood operators in Canada align with the ISBT 128 Standard: Technical Specification. That document is the definitive source describing ISBT 128 and should be consulted when implementing and using ISBT 128. The ISBT 128 Standard: Technical Specification is published on the ICCBBA, Inc website (www.ICCBBA.org). Access to ISBT 128 databases is provided to facilities that register with ICCBBA, Inc. Updates will be made available to facilities that maintain their registration through payment of an annual license fee.

There are several options outlined in the ISBT 128 Standard: Technical Specification that are noted as “nationally determined.” This document provides the options selected by the Canadian blood operators, Canadian Blood Services and Héma-Québec, for blood and components produced in Canada.

Other regulatory requirements may also apply for labelling of blood components.

CAUTION: The illustrations throughout this document are not “real”, accurate representations of ISBT 128 labels. The illustrations are not necessarily to scale. The barcodes are representations only and cannot be scanned. Therefore, barcodes should be printed and positioned on labels according to the ISBT 128 Standard: Technical Specification.

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2. Glossary of Terms

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3. ISBT 128 Standard: Technical Specification

The ISBT 128 Standard: Technical Specification:

• describes the layout for a blood component label
• defines the data identifiers for barcodes used in the transfusion medicine environment
• defines the data structures that carry information, i.e., how a particular barcode will be recognized by a reader, how many characters there are, and whether the characters are letters, numbers or both
• includes tables that define how complex barcodes should be translated, such as ABO/Rh Blood Groups and Type of Donation or Collection
• defines technical details for the barcode itself, such as the width of the narrowest bars and the minimum height of the bars
• describes the variation made in Code 128 to support specialized “concatenation” for linear barcodes
• defines technical details for the use of a 2D barcode that can replace different linear barcodes on a label.

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4. ISBT 128 Data Structures

Data structures define the way in which information is presented in ISBT 128. Each data structure consists of data identifiers and data content. These data structures can be incorporated into many different information delivery systems including linear barcodes, electronic messages, 2-D barcodes and radio frequency ID tags.

Where an ISBT 128 data structure is presented within a Code 128 barcode the data characters are printed in eye-readable format immediately beneath the barcode.

The ISBT 128 data structures of the Code 128 barcodes appearing on labels of blood components produced in Canada are listed in Table 1. Table 2 lists the ISBT 128 data structures that may be visible on the container base label. Each of these data structures are described in subsequent sections of this document.

Refer to the ISBT 128 Standard: Technical Specification for a description of all ISBT 128 data structures.

Table 1: Data Structures Used on Blood Component Labels in Canada

Table 2: Data Structures for Container Base Labels

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Refer to Table 3 for the list of data identifiers associated with the barcodes appearing on labels of blood components produced in Canada. Refer to Table 4 for data identifiers that are associated with the barcodes appearing on container base labels

Table 3: Data Identifiers Used on Blood Component Labels in Canada

Table 4: Data Identifiers Used on Base Labels

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6. ISBT 128 Standard Base Label

Blood containers are labelled with a base label by the manufacturer of the container. The standard ISBT 128 base label is 100 (± 2) mm by 106 (± 2) mm and carries the two manufacturer’s information barcodes in the position shown in Figure 1:

• Container Manufacturer and Catalog Number (Data Structure 017) (barcode 1);
• Container Lot Number (Data Structure 018) (barcode 2).

Refer to the ISBT 128 Standard: Technical Specification for a description of the data structures for these two barcodes.

One or both of the container manufacturer’s information barcodes may be covered by final labelling. It is preferable that the eye-readable text remain visible after the application of the final component label.

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7. ISBT 128 Blood Component Label

The ISBT 128 blood component label is 100 (± 2) mm by 100 (± 2) mm. The label is divided into four quadrants of equal size 50 (±1) mm wide by 50 (±1) mm long.

Regardless of site of collection worldwide, the barcodes should be placed in the same relative positions. The ISBT 128 Standard: Technical Specification defines the placement of the barcodes.

Placement of the barcodes present on labels of blood components produced in Canada is shown in Figure 2:

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Process control can be enhanced through the use of concatenation (reading of two or more barcodes as if they were a single barcode). For this reason, the Donation Identification Number and ABO/Rh Blood Group barcodes have been positioned on the label to facilitate a single scanning motion. The Product Code and Expiration Date and Time barcodes are similarly aligned.

With the exception of the Donation Identification Number, for which the eye-readable information is presented in a specialized way, the data characters in the barcode are printed immediately below the symbol.

The eye-readable representation of the interpreted barcoded information (called barcode text in this document) and any other information on the label (called additional label text in this document) is defined by each blood operator to meet its own requirements.

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8. Description of the ISBT 128 Data Structures

8.1 Data Structure 001: Donation Identification Number

The barcode data structure for the donation number (Data Structure 001) is comprised of 15 data characters (plus the data identifier) as shown below.

Note: This is the only data structure where the second character of the data identifier is part of the data content

Manual Entry Check Character

An additional manual entry check character (not the same character integral to every Code 128 barcode) will be printed, enclosed in a box, to the right of the Donation Identification Number (see Figure 3). This check character should be used to ensure the accuracy of keyboard data entry when supported by the appropriate computer software.

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This check character is calculated on the first 13 data characters of the donation number, excluding the flag characters (i.e. αppppyynnnnnn). The ISO modulo 37,2 method is used to compute this check character. (For further information, see ISBT 128 Technical Specification, Appendix A.)

Flag characters

Flag characters are the last two characters of the Donation Identification Number data structure. They are not part of the Donation Identification Number itself. Flag characters are used in process control by the blood operators. Refer to Table 5 for a list of flag characters used in process control by Canadian blood operators. When printed in eye-readable format on labels of blood components these flag characters will be rotated 90 degrees.

Table 5: Flag Characters Used for Process Control in Canada

For further information regarding definition of additional flag characters refer to Table RT004 - Donation Identification Number Flag Digits in the ISBT 128 Standard: Technical Specification.

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8.2 Data Structure 002: Blood Groups

This data structure provides the coding for the blood groups (ABO/Rh), Rh and Kell phenotypes and type of donation. Its structure is shown below:

Data Structure 002, Table RT007 - Rh, Kell, and Mia/Mur Phenotypes is not used by either Héma-Québec or Canadian Blood Services.

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8.3 Data Structure 003: Product Code

The eight-digit product code data structure includes donation type and allows for definition of additional information including component divisions/splits. The structure is shown below:

The first five (5) digits come from the ICCBBA database and are the ‘core’ product code which defines

• Core conditions – e.g. anticoagulant, volume, storage conditions
• Component Class – e.g. Red Blood Cells, Platelets
• Modifiers – e.g. washed, thawed
• Attributes – e.g. irradiated, residual white count, low platelet count

The 6th digit defines the donation type:

Note: Volunteer homologous (allogeneic) donation is the Canadian default donation type.

The 7^th digit defines a division/split from the original component (e.g. A0, B0) and the 8^th digit defines a division/split from the first divided/split component (e.g. Ba, Bb, Bc).

The ISBT 128 Product Code Database is maintained by ICCBBA. All blood components distributed nationally/internationally must have a standard ISBT 128 product code.

There are no international codes in the ISBT 128 Product Code Database for “in process” components (e.g. first stage of cryoprecipitate production). A set of codes (A0000 – D9999) has been reserved for internal blood agency/facility use for labelling “in-process” components. These codes should not appear on the final label of the blood component. However, components imported from blood operators outside of Canada may be managed by using generic product codes assigned from the “A” series (Héma-Québec) or “B” series (Canadian Blood Services) which are reserved for national blood agency use.

Canadian Blood Services and Héma-Québec share the list of these national codes to avoid conflict in the use of these codes.

Canadian Blood Services and Héma-Québec maintain and provide a list of the product codes used in Canada to the hospitals that they service.

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8.4 Data Structure 005: Expiration Date and Time

Data structure 005 provides the coding for the expiration date and time of the component. The expiration date and time appears on all components.

 Note: For all the products that have a shelf life calculated in days, the expiration time is by default 23:59.

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8.5 Data Structure 007: Collection Date and Time

Data structure 007 provides the coding for the collection date and time of the component. The collection date and time appears on all components except for Pooled Platelets.

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8.6 Data Structure 009: Production Date and Time

Data structure 009 provides the coding for the production date and time of the component. The production date and time appears only on Pooled Platelet components.

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8.7 Data Structure 010: Special Testing (General)

The data content string for data structure 010 Special Testing (General) is encoded and interpreted with reference to the Special Testing database table that is published and maintained by ICCBBA.

The Special Testing (General) data structure indicates special characteristics of a component. In Canada the following special testing codes are used:

This data structure will be found on labels of plasma and pooled platelet components produced by Canadian Blood Services and only on labels of plasma components produced by Héma-Québec.

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8.8 Data Structure 012: Special Testing: Red Blood Cell Antigens - General

The data content string for data structure 012 Special Testing: Red Blood Cell Antigens – General is encoded and interpreted with reference to Tables RT009 and RT011 of the ISBT 128 Standard: Technical Specification.

If additional red cell antigen testing has been performed but cannot be encoded in the barcode structure, the information may appear on the label in eye-readable form only.

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8.9 Data Structure 014: Special Testing: Platelet HLA and Platelet- Specific Antigens

The data content string for data structure 014 Special Testing: Platelet HLA and Platelet-Specific Antigens is encoded and interpreted with reference to Tables RT013, RT014 and RT044 of the ISBT 128 Standard: Technical Specification.

This data structure provides information regarding HLA and HPA phenotypes, CMV antibody status, IgA status and information regarding high titered antibodies to A and B antigens for platelet products.

Note 1: The HLA phenotypes appear in eye readable format only and are not encoded in the Special Testing barcode.  For Canadian Blood Services only, the HPA phenotypes also appear in eye readable format only and are not encoded in the Special Testing barcode.

Note 2: Information regarding high titered antibodies to A and B antigens is displayed on the label by “T.E.N.D./H.T.N.D.” (Héma-Québec) or “Low Anti-A/B” (Canadian Blood Services) which means High Titre Not Detected.

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8.10 Data Structure 017: Container Manufacturer and Catalog Number

Data structure 017 provides coding to specify the manufacturer and catalog number of the container set and the identifying character(s) of the individual container(s) in the set. This data structure is not normally visible on the labelled blood component; however the eye-readable barcode text may be visible.

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8.11 Data Structure 018: Container Lot Number

Data structure 018 is a 10-character alphanumeric data string that encodes the manufacturer’s lot number for the container set. This data structure is not normally visible on the labelled blood component, however the eye-readable barcode text may be visible.

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9. Uniform Labelling Using ISBT 128

9.1 Barcodes and Barcode Text

Dates will be printed in the format day month year. The day will be numerical, the month alphabetical, using a three-letter abbreviation. Refer to Table 6 for the month abbreviations used in Canada. The year will be a four-digit numerical representation.

Table 6: Month Abbreviations Used in Canada

Times will be printed based on a twenty-four-hour clock with a colon placed between the hours and minutes.

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9.2 Component Description

Additional label text providing a description of the component will appear in the bottom left quadrant below the product code barcode.

The order of component information presented on the labels varies between Canadian Blood Services and Héma-Québec. Refer to the label examples shown in Sections 9.4 and 9.5. The component description text (including font and font sizes) in these label examples may not represent the most current label.

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9.3 Eye-readable Red Cell Phenotypes

Rules for printing of the eye-readable red cell phenotypes on the final label are as shown below:

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9.4 Canadian Blood Services Labels

Canadian Blood Services uses the standard 100 mm by 100 mm ISBT 128 Blood Component Label for all blood components. An example of a label for a Red Blood Cell component is shown in Figure 4.

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9.4.1 Components for Transfusion

Component description information will be presented in the lower left portion of the label of components for transfusion in the order described below:

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• Modifiers include:
  • Apheresis
  • Washed
  • Extra Washed
  • Frozen
  • Deglycerolized
  • Cryosupernatant
• Attributes, when applicable, will normally be presented in the following order:
  • Leukoreduction
  • Low Volume / Low Count
  • Psoralen-Treated
  • Divided
  • Irradiation
  • Other descriptors (e.g. container number)
• Component Description will normally be presented in the following order:
  • Component Volume
  • Nominal collection volume/anti-coagulant
  • Additive solution
  • Storage Conditions
• Additional test results include:
  • Red Cell Antibody
  • Indication of Untested status for components distributed by Emergency Release and Untested Autologous donations
  • Indication of Subsequent Testing for Autologous donations
  • Volume of anticoagulant present in apheresis plasma/platelet components

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9.4.2 Recovered Plasma and Cryosupernatant Plasma for Further Manufacturing

Component description information will be presented in the lower left portion of the label of components for further manufacturing in the order described below:

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The list of tests performed on the donation is printed in the lower right quadrant of the label.

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9.4.3 Source Plasma for Further Manufacturing

Component description information will be presented in the lower left portion of the Source Plasma label in the order described below:

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The list of tests performed on the donation is printed in the lower right quadrant of the label.

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9.5 Héma-Québec Labels

Héma-Québec uses the standard 100 mm by 100 mm ISBT 128 Blood Component Label for all blood components. An example of a label for a Red Blood Cell component is shown in Figure 5.

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9.5.1  Components for Transfusion

Because of the need for bilingual labels (French and English) with prevalence for French, the general principles for printing can be slightly different than what is suggested in the ISBT 128 documentation. Component description information will be presented in the lower left portion of the label of components for transfusion in the order described below:

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• Modifier(s), divisions or type of donation include:
  • Apheresis
  • Washed
  • Deglycerolized
  • Division number
  • Designated
  • International
• Component name (French and English)
  • Additive solutions for red blood cells are associated to the component name
  • The following modifiers may be associated to the component name
    • Washed
    • Deglycerolized
    • Frozen
• Component name (English)
  • Always printed in capital letters because the font size is smaller than the component name in French
• Attributes, when applicable, will normally be presented in the following order:
  • Leukoreduction
  • Low Volume
  • Irradiation
• Component Description will normally be presented in the following order:
  • Component Volume
  • Nominal collection volume
  • Anticoagulant
  • Storage conditions
  • Standard Apheresis Platelet Count

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9.5.2 Plasma and Cryo reduced Plasma for fractionation

Component description information will be presented in English only in the lower left portion of the Plasma label in the order described below:

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9.5.3 Apheresis Plasma for fractionation

Component description information will be presented in English only in the lower left portion of the Plasma label in the order described below:

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Appendix 1: Data Structure 002: Blood Groups

Extracted from: ISBT 128 Standard Technical Specification
   Table RT005: Data Structure 002: Blood Groups [ABO and RhD], Including Optional Type of Donation or Collection Information

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