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ST 010 ISBT 128 Standard Product Description Code Database v6.0.0

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The key takeaways are that the ISBT 128 standard is used for blood product labeling and its implementation requires registration and an annual license fee. No warranties are provided regarding its suitability for any particular purpose.

The Product Attribute Map Table provides a mechanism for identifying trends or commonalities in products of interest during biovigilance efforts by listing and associating each Product Description code with pertinent Attribute Values.

The Modifier Category Map Table creates associations between Modifiers and their appropriate Categories by mapping Category number identifiers to Modifier identifiers.

ISBT 128 STANDARD

Product Description Code


Database
Version 6.0.0

October 2014
Tracking Number ICCBBA ST-010

Published by:
ICCBBA
PO Box 11309, San Bernardino, CA 92423-1309 USA

Telephone: +1.909.793.6516
E-mail: iccbba@iccbba.org

Fax: +1.909.793.6214
Website: http://www.iccbba.org

Product Description Code Database v6.0.0

Warranty
ICCBBA provides no warranty that the use of ISBT 128 is suitable for any particular purpose and the
selection, use, efficiency, and suitability of ISBT 128 is the sole responsibility of the Licensed User.
There are no guarantees or warranties attached to this Standard other than that ICCBBA agrees to
furnish registered and licensed end-users with the most up-to-date information available. Successful
implementation of this Standard, and use of any accompanying database table(s), depend(s) upon
the correct incorporation of the rules and table contents into the software used by or provided to the
registered and licensed facility. ICCBBA makes no other warranties of any kind, whether expressed or
implied, including any implied warranty of merchantability or fitness for any particular purpose. Further
information can be found at www.iccbba.org.

Liability
ICCBBA's liability is limited to that specified in the ICCBBA License Agreement which is available on
the ICCBBA Website. Under no circumstances shall ICCBBA's liability exceed the current annual
license fee, and ICCBBA will in no circumstances be liable for any damages whatsoever, including
without limitation damages for loss of data, business or goodwill, or any other consequential losses of
any nature arising from the use of ISBT 128.
ICCBBA manages the ISBT 128 Standard. ICCBBA is not an accrediting organization and is not
responsible for adherence to the standard, the selection of product codes, or product labeling by
facilities registered for its use.

COPYRIGHT NOTICE AND LICENSING INFORMATION


ISBT 128 is not in the public domain and is protected by law. Implementation of ISBT 128 requires
the end-user to register with ICCBBA and to pay an annual license fee. License fees are established
by the ICCBBA Board of Directors to cover the expenses of maintaining and extending ISBT 128, and
making available current versions of the documents and database tables that are needed to
implement this Standard.
This Standard is intended for the use of those implementing ISBT 128, regulatory agencies, and
software developers and other manufacturers that support end-users.
Although it is made available to anyone wishing to obtain a copy, national Guidelines describing its
use in a particular country may be an additional source of information for the end-user. If such
Guidelines exist, they must be consulted because there are options in ISBT 128, and countryspecific information pertaining to the particular use of such options will only be found in such
Guidelines.
Any use of this Standard, or the accompanying database tables, by other than registered and
licensed facilities, or facilities that have obtained their computer software from a registered and
licensed developer, is strictly forbidden. Copying any portion of the Standard, or of any
accompanying database table, either in electronic or other format, without express written permission
from ICCBBA is strictly forbidden. Posting of any portion of the Standard, or of any accompanying
database table, to any online service by anyone other than ICCBBA is strictly forbidden.

2014 ICCBBA All rights reserved

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Product Description Code Database v6.0.0

Editor
Erwin Cabana
Lead Information Standard Specialist, ICCBBA

Standards Committee
John Armitage, Prof., BSc, PhD

United Kingdom

Paul Ashford, MSc. CEng. CSci.

ICCBBA

Wayne Bolton, B.App.Sc., M.App.Sc

Australia

Suzanne Butch, MA, MT(ASCP)SBB

United States of America

Pat Distler, MS, MT(ASCP)SBB

ICCBBA

Jrgen Georgsen, MD

Denmark

Suzy Grabowski, BA, BB(ASCP)SBB

United States of America

Mario Muon, MD

Portugal

Stefan Poniatowski, BSc, MIBMS

Australia

Leigh Sims Poston, BS, MT(ASCP)

United States of America

Ineke Slaper-Cortenbach, PhD

The Netherlands

Zbigniew Szczepiorkowski, MD, PhD, FCAP

United States of America

Izabela Uhrynowska-Tyszkiewicz, MD, PhD

Poland

Diane Wilson, BSN, MSN/MHA

United States of America

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Product Description Code Database v6.0.0

Table of Contents
1

Introduction ......................................................................................................................... 7
1.1

Purpose ....................................................................................................................... 7

1.2

Scope .......................................................................................................................... 7

1.3

Intended Audience ....................................................................................................... 7

1.4

Normative References ................................................................................................. 7

1.5

Other Reference .......................................................................................................... 7

1.6

Background.................................................................................................................. 7

1.7

New in this Version ...................................................................................................... 9

Original Database Tables...................................................................................................10


2.1

Attribute Table ............................................................................................................10

2.1.1
2.2

Class Table .................................................................................................................11

2.2.1
2.3

New Tables that Replace the Class Table ...........................................................12

Product Description Table ...........................................................................................12

2.3.1
2.4

New Tables that Replace the Attribute Table .......................................................11

New Tables that Replace the Product Description Table .....................................14

Version Table..............................................................................................................15

New Database Tables ........................................................................................................16


3.1

Categories Table ........................................................................................................18

3.1.1

Structure ..............................................................................................................18

3.1.2

Related Tables.....................................................................................................19

3.2

Subcategories Table ...................................................................................................20

3.2.1

Structure ..............................................................................................................20

3.2.2

Related Tables.....................................................................................................20

3.3

Classes Table .............................................................................................................21

3.3.1

Structure ..............................................................................................................21

3.3.2

Related Tables.....................................................................................................22

3.4

Modifiers Table ...........................................................................................................23

3.4.1

Structure ..............................................................................................................23

3.4.2

Related Tables.....................................................................................................23

3.5

Class Modifier Combinations Table .............................................................................25

3.5.1
3.6

Structure ..............................................................................................................25

Attribute Groups Table ................................................................................................26

3.6.1

Structure ..............................................................................................................26

3.6.2

Related Tables.....................................................................................................26

3.7

Attribute Values Table.................................................................................................27

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Product Description Code Database v6.0.0

3.7.1

Structure ..............................................................................................................27

3.7.2

Related Tables.....................................................................................................28

3.8

Product Description Codes Table................................................................................29

3.8.1

Structure ..............................................................................................................29

3.8.2

Related Tables.....................................................................................................31

Mapping Tables in the Database........................................................................................32


4.1

Modifier Category Map Table ......................................................................................32

4.1.1
4.2

Product Attribute Map Table .......................................................................................33

4.2.1
4.3

Structure ..............................................................................................................32
Structure ..............................................................................................................33

Attr Old New Map Table ..............................................................................................34

4.3.1

Structure ..............................................................................................................34

Tables
Table 1 Expanded Capacity of Product Description Code Database ......................................... 8
Table 2 Attribute Table [RT026] ...............................................................................................10
Table 3 Example Attribute Table ..............................................................................................10
Table 4 Class Table [RT025]....................................................................................................11
Table 5 Example Class Table ..................................................................................................12
Table 6 Product Description Table [RT027] ..............................................................................12
Table 7 Example of Product Description Table.........................................................................14
Table 8 Version Table [RT028] ................................................................................................15
Table 9 Example of Version Table ...........................................................................................15
Table 10 Categories Table [RT047] .........................................................................................18
Table 11 Example of Categories Table ....................................................................................18
Table 12 Subcategories Table [RT048] ....................................................................................20
Table 13 Example of Subcategories Table ...............................................................................20
Table 14 Classes Table [RT049] ..............................................................................................21
Table 15 Example of Classes Table .........................................................................................21
Table 16 Modifiers Table [RT050] ............................................................................................23
Table 17 Example of Modifiers Table .......................................................................................23
Table 18 Class Modifier Combinations Table [RT051]..............................................................25
Table 19 Example of Class Modifier Combinations table ..........................................................25
Table 20 Attribute Groups Table [RT052] .................................................................................26
Table 21 Example of Attribute Groups Table ............................................................................26
Table 22 Attribute Values Table [RT053]..................................................................................27
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Product Description Code Database v6.0.0

Table 23 Examples of Attribute Values Table ...........................................................................27


Table 24 Product Description Codes Table [RT054].................................................................29
Table 25 Example of Product Description Codes Table ...........................................................30
Table 26 Modifier Category Map Table [RT055] .......................................................................32
Table 27 Example of Modifier Category Map Table ..................................................................32
Table 28 Product Attribute Map Table [RT056] ........................................................................33
Table 29 Example of Product Attribute Map Table ...................................................................33
Table 30 Attr Old New Map Table [RT057]...............................................................................34
Table 31 Example of Attr Old New Map Table..........................................................................34

Figures
Figure 1 Entity Relationship Diagram .......................................................................................16
Figure 2 Entity Relationship Diagram Showing Example Instances ..........................................17

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Product Description Code Database v6.0.0

1
1.1

Introduction

Purpose
The purpose of this document is to provide specifications and guidance for the use of the
ISBT 128 Product Description Code Database. This database has been restructured to
allow for better information management and more coding options.

1.2

Scope
This document describes the structure of the Product Description Code Database. It
provides reference tables for the characteristics of each table comprising the database
and describes the relationships between each of the database tables.

1.3

Intended Audience
The intended audience of this document is software developers and staff (management,
information technology, quality, validation, and laboratory) at facilities using ISBT 128.

1.4

Normative References
ISBT 128 Standard Technical Specification

1.5

Other Reference
ICCBBA Website (www.iccbba.org)

1.6

Background
The ISBT 128 Product Description Code Database provides reference tables for Product
Descriptions, Classes, Modifiers, and Attributes. It has existed since 1996. The original
database was structured to accommodate uniqueness only for blood products. As ISBT
128 expanded into cellular therapy and tissue products, separate databases were
created that adopted the same structure as the original one for blood. All three
databases were eventually merged, requiring new unique fields to be created and
causing some of the existing fields to become obsolete.
As the use of ISBT 128 continues to grow (more than 10,000 Product Description codes
in eight Categories of products now exist), ICCBBA foresees that the original database
design will not continue to be adequate. While its limitations have not been reached,
based on current growth patterns, this will happen in the not-distant future. Therefore, a
new database design was created to replace the original database. By making the
restructured database available now, it gives software developers time to adapt their
software before the old database design is unable to handle the number and variety of
products using ISBT 128. While it cannot be foreseen just how long the old database
design will continue to meet the needs, ICCBBA strongly recommends that software that
utilizes more than just the Product Description codes (e.g., uses product formulas) be

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Product Description Code Database v6.0.0

updated as soon as possible. ICCBBA will continue producing the current tables for up
to 3 years (end of 2016, unless the original table structures can no longer support new
products).
The structure of the new database may not affect all existing ISBT 128 software. Existing
software that only utilizes the ISBT 128 Product Description code should not be affected.
The Product Description codes themselves have not been redefined or restructured.
The restructured database was designed in a way that supports growth. Table 1 shows
some areas in which the new design permits more codes.
Table 1 Expanded Capacity of Product Description Code Database
Original Database
Number of Class-Modifier Combinations
per product Category: 999
Number of Attribute Groups per product
Category: 26
Number of Attribute Values per group: 36

Restructured Database
Number of Classes: 9,999
Number of Modifiers: 9,999
Number of Attribute Groups: 9,999
Number of Attribute Values per group:
9,999

Two new levels have been added above the level of the Class to allow groupings of
Classes. These are Category and Subcategory. Category relates to the highest level of
distinction and in the old database is represented by the letter used at the start of the
Product Description code. The Category code will be the means to group products under
general headings such as blood, cellular therapy, tissues, etc. The Subcategory is a new
level which potentially allows a level of classification between the Category and Class.
An example may be the Blood Components Category which could have in the future
Subcategories of Red Blood Cells, Platelets, and Plasma.
Additionally, the new design of the database supports biovigilance and activity reporting
by having hierarchical categorizations of product types and by providing associations of
Attributes to those product types.

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Product Description Code Database v6.0.0

1.7

New in this Version


The version for this document skipped from the previous 1.0.0 to 6.0.0. There were no
other versions of this document between 1.0.0 and 6.0.0. This version number will tie
the new ISBT 128 Product Description Code Database to the controlling version of this
document. That is, if this document (ST-010) is version 6.x.x, the database shall be
version 6.y.y.
The following table indicates the changes between Version 1.0.0 and Version 6.0.0.

1.

Version 1.0.0

Version 6.0.0

Chapter,
Section,
Table, or
Figure

Chapter,
Section,
Table, or
Figure

Throughout

Throughout

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Change

Rationale

Data and coding values


used in the tables,
figures, and document
text were updated to
reflect those found in
the new ISBT 128
Product Description
Code Database.

The data and coding


values used in version
1.0.0 were not official
and were preliminary
examples prior to the
release of the new
database.

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Product Description Code Database v6.0.0

10

Original Database Tables

The original Product Description Code Database contained three tables: Attribute, Class, and
Product Description. A Version table was added in 2005. The restructured Product Description
Code database contains these original tables in addition to several new tables. The original
tables are maintained and kept available to allow sufficient time for software developers to
transition to the new database tables.

2.1

Attribute Table
The Attribute table lists Attribute Values for all product Categories, as well as the group
to which each Attribute belongs. Each Attribute is assigned a unique code which is
provided in the field called UNIQUE ATTRFORM. The group names are distinguished by
codes ending in 0 (e.g., E@00 identifies the Core Conditions group; EA0 identifies the
Intended Use group for blood).
The code for each Attribute begins with an alpha character that indicates the Category of
product to which it belongs. For example, all blood Attribute formulas in the UNIQUE
ATTRFORM field begin with the letter E; tissue Attribute formulas begin with the letter T,
etc. Codes for Attribute Groups and the Class to which they belong begin with the same
alpha character.
Table 2 Attribute Table [RT026]

ATTRGRP
ATTRVAR

Field
Type
Text
Text

Field
Size
1
2

ATTRNAME

Text

50

ATTRFORM
UNIQUE
ATTRFORM

Text

Text

Text

11

Field Name

RETIREDATE

Description of Information in this Field


Identifier for Attribute Group.
Identifier for Attribute variable within a group.
Description of the Attribute Group and variable (note:
the group description is in the row with a variable value
of zero).
Obsolete Field is depopulated.
Unique identifier for the Attribute value combining the
product type, Attribute Group, and variable.
Date on which it was recommended the code no longer
be used for new products. The code is maintained in
database for backward compatibility. Format is DD
MMM YYYY. The field is not populated for active
codes.

Table 3 Example Attribute Table


Attribute Table Excerpt
ATTRGRP

ATTRVAR

ATTRNAME

@
@
@

00
01
02

Core Conditions
ACD-A/450mL/refg
ACD-B/450mL/refg

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ATTRFORM

UNIQUE
ATTRFORM
E@00
E@01
E@02

RETIREDATE

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Product Description Code Database v6.0.0

11

Attribute Table Excerpt


ATTRGRP

ATTRVAR

@
@

03
04

ATTRNAME

ATTRFORM

CPD/450mL/refg
CPD/500mL/refg

UNIQUE
ATTRFORM
E@03
E@04

RETIREDATE

2.1.1 New Tables that Replace the Attribute Table


There are two types of information conveyed in the original Attribute table; the
Attribute Groups and the Attribute Values within a group. The restructured
database separates these two types of information into different tables: the
Attribute Groups table and the Attribute Values table. Alpha characters
associated with a given product Category are no longer used in Attribute Group
or Value codes on the new tables. Details for these tables are discussed later.

2.2

Class Table
The Class table lists all Class-Modifier combinations used for the various types of
products. Each Class-Modifier combination has a unique identifier assigned to it in the
UNIQUE NAMECODE field. The first character of each identifier denotes the Category of
product of the Class-Modifier combination. For example, Class-Modifier combinations
pertaining to blood products begin with an E.
Table 4 Class Table [RT025]
Field Name

Field
Type

Field
Size

NAMECODE

Text

Obsolete Field is to be depopulated in the near


future.

MODIFIER

Text

35

Modifier relates to a set of conditions that


distinguishes members of the same component
Class, e.g., Washed, Frozen, etc.

CLASS

Text

36

The basic naming system adopted for products in


ISBT 128

NAME

Text

75

The unique name produced by combining the


Modifier and the Class

UNIQUE
NAMECODE

Text

Unique identifier for the Class/Modifier of product

11

Date on which it was recommended the code no


longer be used for new products. The code is
maintained in database for backward
compatibility. Format is DD MMM YYYY. The
field is not populated for active codes.

RETIREDATE

Text

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Description of Information in this Field

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Product Description Code Database v6.0.0

12

Table 5 Example Class Table


Class Table Excerpt
NAMECODE

MODIFIER

CLASS
WHOLE
BLOOD
RED
BLOOD
CELLS
RED
BLOOD
CELLS
RED
BLOOD
CELLS

001
002

003

Washed

004

Frozen

NAME

UNIQUE
NAMECODE

WHOLE BLOOD

E001

RED BLOOD
CELLS

E002

Washed RED
BLOOD CELLS

E003

Frozen RED
BLOOD CELLS

E004

RETIRE
DATE

2.2.1 New Tables that Replace the Class Table


The original Class table captured three types of information: Class names,
Modifier names, and combinations of Class and Modifier. These are now
separated into their own tables: Classes table, Modifiers table, and Class
Modifier Combinations table. Within its respective table, each Class and Modifier
has its own unique identifier used in the formula of a Product Description code.
Alpha characters associated with a particular product Category are not used in
new codes for Classes and Modifiers. Details for these tables are discussed
later.

2.3

Product Description Table


All Product Description codes are listed, described, and assigned a unique formula in the
Product Description table. The formula is created from the identifiers found in the Class
table and the Attribute table. There are two fields in the Product Description table that
contain unique information: the PRODDESCRIPCODE field where the Product
Description code is listed and the PRODDESCRIPCODEFORM field where the formula
for each Product Description is provided. No two Product Description formulas can be
the same ensuring that Product Descriptions are not duplicated.
Table 6 Product Description Table [RT027]

Field Name

Field
Type

Field
Size

PRODDESCRIPCODE

Text

NAMECODE

Text

COMBATTRFORM

Text

60

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Description of Information in this Field


The unique Product Description Code for the
product.
Obsolete Field is to be depopulated in the
near future.
Obsolete Field is depopulated.
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Product Description Code Database v6.0.0

13

Field Name

Field
Type

Field
Size

PRODDESCRIP0

Text

254

CODEDATE

Text

11

PRODDESCRIP1

Text

254

PRODCODEFORM

Text

50

PRODDESCRIPCODEFORM

Text

65

RETIREDATE

Text

11

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Description of Information in this Field


The description of the product in structured
format.
The date the code was assigned. Format is DD
MMM YYYY.
Field available for national descriptions, not
populated by ICCBBA.
Obsolete Field is depopulated.
Unique formula for the product comprising the
Class description (corresponds to UNIQUE
NAMECODE in the Class Table) and the
combined Attribute codes (corresponds to
UNIQUE ATTRFORM in the Attribute Table).
Date on which it was recommended the code
no longer be used for new products. The code
is maintained in database for backward
compatibility. Format is DD MMM YYYY. The
field is not populated for active codes.

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Product Description Code Database v6.0.0

14

Table 7 Example of Product Description Table


Product Description Table Example
PROD
DESCRIP
CODE

NAME
CODE

E0023

001

S1128

005

T0293

311

COMB
ATTR
FORM

PROD DESCRIP0
WHOLE BLOOD
|CPD/500mL/refg
HPC, APHERESIS
|Citrate/XX/ refg|
Mobilized
MENISCUS, LATERAL
|Frozen|Left

CODE
DATE

PROD
DESCRIP1

PRODCODE
FORM

PRODDESCRIP
CODEFORM

19 JUL
1996

E001E@04

17 JUL
2007

S005S@34SM2

08
AUG
2011

T311TT2TV2

RETIREDATE

2.3.1 New Tables that Replace the Product Description Table


A new Product Description Codes table replaces the original Product Description table. Some of the fields in the
original Product Description table are obsolete, as noted in Table 6. The new Product Description Codes table no
longer contains these obsolete fields and additional fields were added to allow for hierarchical categorization. Details
on the structure of the new Product Description Codes table are discussed later.

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Product Description Code Database v6.0.0

2.4

15

Version Table
The Version table identifies the version number of the product database and the date it
was published. Although the Version table was not actually part of the original database,
it is included in this section since it existed prior to the restructuring of the new database.
The structure and format of this table remain unchanged.
Table 8 Version Table [RT028]

Field Name
Version Number
Date

Field
Type
Text
Text

Field
Size
50
11

Description of Information in this Field


The version number of the product database.
The date issued. The format is DD MMM YYYY.

Table 9 Example of Version Table


Version Table
Version Number
Date
5.3.0
02 SEP 2014

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Product Description Code Database v6.0.0

16

New Database Tables

The new tables in the restructured database replace the original tables, although the older
tables will be made available for a time (see 1.6). An exception to this is the Version table,
which will continue to be used as part of the restructured database and remains unchanged.
Figure 1 shows the entities within the restructured database. Entities are shown as boxes and
represented in the database as tables. The arrows indicate the relationship between entities.
The arrow ends indicate whether the relationship is one (single headed) or many (double
headed). For example, in the figure below, a Category can map to many Subcategories.
However, a Subcategory can map to only one Category.
Figure 1 Entity Relationship Diagram

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Product Description Code Database v6.0.0

17

Figure 2 Entity Relationship Diagram Showing Example Instances

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Product Description Code Database v6.0.0

3.1

18

Categories Table
Categories define the highest level of categorization within the database and correspond
to the fields of practice supported by ISBT 128: blood, cells, tissue, ocular tissue,
reproductive tissue, organs, other blood products, and other therapies.
The Categories table lists product Categories, assigns each a unique Category number
(Cat No), and associates each with an alpha character (), the character within the
Product Description Code (oooo) used to specify the Category of the product. The
Category number is used in other tables to associate values with a Category.

3.1.1 Structure
Table 10 Categories Table [RT047]
Field
Name
Cat No
Category

Field
Type
Number
Text

Field
Size
n/a
255

Description of Information in this Field


Key field sequence number.
Text description of the Category.
Letter assigned to the first character of the Product
Description code for that Category.

OldCode

Text

1
This is a temporary field for ICCBBA internal use to
support the upload of the old database into the new.

Table 11 Example of Categories Table

Cat No
1
2
3
4
5
6
7
8

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Categories Table
Category
Blood Components
Cellular Therapy
Tissues
Other Blood Products
Ocular
Other Therapies
Organs
Reproductive

OldCode
E
S
T
X
V
M
N
R

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Product Description Code Database v6.0.0

19

3.1.2 Related Tables


Table

Relationship to Categories Table


A foreign key (Category field) in the Subcategories table
maps to the key field (Cat No) in the Categories table.

Subcategories

Modifier Category
Map

Each Subcategory instance shall map to an instance in the


Categories table.
A foreign key (Category field) in the Modifier Category Map
table maps to the key field (Cat No) in the Categories table.
Each Modifier Category Map instance shall map to an
instance in the Categories table.
A foreign key (Category field) of the Attribute Groups table
maps to the key field (Cat No) in the Categories table.

Attribute Groups
Each Attribute Group instance shall map to an instance in
the Categories table.

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Product Description Code Database v6.0.0

3.2

20

Subcategories Table
Subcategories define the second level of categorization within the database. Each
Subcategory is associated with one Category. However, a Category may have multiple
Subcategories.
Use of Subcategories for products could support biovigilance efforts when an adverse
event is found, or suspected, to be associated with a particular Subcategory of product.

3.2.1 Structure
Table 12 Subcategories Table [RT048]

Subcat No
Subcategory

Field
Type
Number
Text

Field
Size
n/a
255

Category

Number

n/a

Field Name

Description of Information in this Field


Key field sequence number.
Text description of the Subcategory.
Foreign key to the Categories table.

Table 13 Example of Subcategories Table


Subcategories Table
Subcat
No
1
2
3
4
5
6
7
8

Subcategory

Category

Blood Components
Cellular Therapy
Tissues
Other Blood Products
Ocular
Other Therapies
Organs
Reproductive

1
2
3
4
5
6
7
8

3.2.2 Related Tables


Table

Relationship to Subcategories Table


A foreign key (Subcategory) in the Classes table maps to a
key field (Subcat No) in the Subcategories table.

Classes
Each Classes instance shall map to an instance in the
Subcategories table.

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Product Description Code Database v6.0.0

3.3

21

Classes Table
Classes are the third level of categorization of products in the database, and the highest
level of description used in labeling. Examples of ISBT 128 Class names are Red Blood
Cells; HPC, Cord Blood; Dermis; Cornea; Human Milk; Embryo; and Solvent Detergent
Pooled Plasma. Classes support biovigilance efforts when an adverse event is found, or
suspected, to be associated with a particular Class of product.

3.3.1 Structure
Table 14 Classes Table [RT049]

ClassIdentifier
ClassName

Field
Type
Text
Text

Field
Size
5
36

StructuredName

Text

255

RETIREDATE

Text

11

Number

n/a

Field Name

Subcategory

Description of Information in this Field


Key field Class number Cxxxx.
Text description of Class.
Structured description of Class. This field is
not currently populated.
Date on which the Class was retired. Format is
DD MMM YYYY. The field is not populated for
active codes.
Foreign key to the Subcategories table.

Table 15 Example of Classes Table


Classes Table Excerpt
ClassIdentifier

ClassName

C0001
C0002
C0003
C0004
C0005
C0006
C0007
C0008

WHOLE BLOOD
RED BLOOD CELLS
FRESH FROZEN PLASMA
PLASMA
PLATELET-RICH PLASMA
PLATELETS
POOLED PLATELETS
CRYOPRECIPITATE
POOLED
CRYOPRECIPITATE
GRANULOCYTES
POOLED
GRANULOCYTES
GRANULOCYTESPLATELETS
LEUKOCYTES
POOLED PLASMA

C0009
C0010
C0011
C0012
C0013
C0014

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StructuredName

RETIRE
DATE

Subcategory
1
1
1
1
1
1
1
1
1
1
1
1
1
1

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22

Classes Table Excerpt


ClassIdentifier
C0015
C0016

ClassName

RETIRE
DATE

Subcategory

PLATELET-RICH BUFFY
COAT
POOLED PLATELET-RICH
BUFFY COAT

C0017

LYMPHOCYTES

C0018

MONOCYTES

C0019
C0020

SERUM
POOLED SERUM
POOLED FRESH FROZEN
PLASMA

C0021

StructuredName

1
1
03 MAY
2010
03 MAY
2010

1
1
1
1
1

3.3.2 Related Tables


Table

Class Modifier
Combinations

Product Description
Codes

Relationship to Classes Table


A foreign key (ClassIdentifier) in the Class Modifier
Combinations table maps to a key field (ClassIdentifier) in
the Classes table.
Each Class Modifier Combinations instance shall map to
an instance in the Classes table.
A foreign key (Class Identifier) in the Product Description
Codes table maps to a key field (ClassIdentifier) in the
Classes table.
Each Product Description Codes instance shall map to an
instance in the Classes table.

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Product Description Code Database v6.0.0

3.4

23

Modifiers Table
In some Categories of products, Modifiers are applied to Classes in order to provide the
next step in describing a product. Examples are Frozen, Thawed, Washed, etc.
Modifiers are not used with all Categories of products.
The Modifiers table lists Modifiers and assigns each a unique identifier
(ModifierIdentifier). It allows assignment of a retirement date to a Modifier.

3.4.1 Structure
Table 16 Modifiers Table [RT050]

ModifierIdentifier
ModifierName

Field
Type
Text
Text

Field
Size
5
255

RETIREDATE

Text

11

Field Name

Description of Information in this Field


Key field Modifier number Mxxxx.
Text description of Modifier.
Date on which the Modifier was retired. Format
is DD MMM YYYY. The field is not populated
for active codes.

Table 17 Example of Modifiers Table


Modifiers Table Excerpt
ModifierIdentifier
ModifierName
M0000
M0001
Washed
M0002
Frozen
M0003
Frozen Rejuvenated
M0004
Deglycerolized
M0005
Deglycerolized Rejuvenated

RETIREDATE

3.4.2 Related Tables


Table

Class Modifier
Combinations

Product Description
Codes

Relationship to Modifiers Table


A foreign key (ModifierIdentifier) in the Class Modifier
Combinations table maps to a key field (ModifierIdentifier)
in the Modifiers table.
Each Class Modifier Combinations instance shall map to
an instance in the Modifiers table.
A foreign key (Modifier Identifier) in the Product
Description Codes table maps to a key field
(ModifierIdentifier) in the Modifiers table.
Each Product Description Codes instance shall map to an
instance in the Modifiers table.

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Product Description Code Database v6.0.0

Table

Modifier Category
Map

24

Relationship to Modifiers Table


A foreign key (Modifier) in the Modifier Category Map
maps to a key field (ModifierIdentifier) in the Modifiers
table.
Each Modifier Category Map instance shall map to an
instance in the Modifiers table.

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Product Description Code Database v6.0.0

3.5

25

Class Modifier Combinations Table


Each Class/Modifier combination is uniquely identified in this table. A Class/Modifier
combination includes the combination of a Class with a null Modifier. Additionally, more
than one Modifier may be used to describe a product. Therefore the table captures
combinations of multiple Modifiers with a single Class (e.g., Washed Apheresis RED
BLOOD CELLS). In such cases, the combination is treated as a single Modifier (e.g.,
Washed Apheresis is treated as a single Modifier with its own ModifierIdentifier).
The Class Modifier Combinations table assigns each combination a ClassIdentifier and
ModifierIdentifier. It associates a Class Modifier combination with a Unique NameCode
allowing it to be mapped to the older coding system. It corresponds to the Class and
Modifier combinations used in the original Class table.

3.5.1 Structure
Table 18 Class Modifier Combinations Table [RT051]
Field Name

Field
Type

Field
Size

ClassIdentifier

Text

ModifierIdentifier

Text

Name

Text

75

RETIREDATE

Text

11

UNIQUE
NAMECODE

Text

Description of Information in this Field


Key field Class number Cxxxx. Foreign key to Classes
table.
Key field Modifier number Mxxxx. Foreign key to
Modifiers table.
Text description of Class-Modifier combination.
Date on which the Class-Modifier combination was
retired. Format is DD MMM YYYY. The field is not
populated for active codes.
Previous identifier of the Class-Modifier combination.
This corresponds to the unique identifier from the
original Class table.

Table 19 Example of Class Modifier Combinations table


Class Modifier Combinations Table Example
ClassIdentifier ModifierIdentifier
C0004
C0004
C0004

M0000
M0007
M0008

C0004

M0009

C0004

M0010

C0004

M0013

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Name
PLASMA
Apheresis PLASMA
Thawed PLASMA
Thawed Apheresis
PLASMA
Liquid PLASMA
Liquid Apheresis
PLASMA

RETIREDATE

UNIQUE
NAMECODE
E017
E014
E018
E015
E016
E041

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Product Description Code Database v6.0.0

3.6

26

Attribute Groups Table


The Attribute Groups table contains an entry for each Attribute Group, assigns each a
unique identifier (GroupIdentifier), and associates it with a Category. It allows the
assignment of a retirement date to an Attribute Group.

3.6.1 Structure
Table 20 Attribute Groups Table [RT052]
Field Name

Field
Type

Field
Size

GroupIdentifier

Text

GroupName

Text

100

RetireDate

Text

11

Number

n/a

Category

Description of Information in this Field


Key field, sequentially assigned group number in the
format Vxxxx.
Text description of the Attribute Group.
Date on which the Attribute Group was retired. Format
is DD MMM YYYY. The field is not populated for active
codes.
Foreign key to the Categories table.

Table 21 Example of Attribute Groups Table


Attribute Groups Table Excerpt
GroupIdentifier
GroupName
RetireDate
Method of Treatment
V0021
Hematocrit
V0022
V0023
Platelet Count
01 SEP 2009
Monitoring
V0024
Donor Exposure
V0025

Category
1
1
1
1
1

3.6.2 Related Tables


Table

Attribute Values

Attr Old New Map

Relationship to Attribute Groups Table


A foreign key (ATTRGRP) in the Attributes Values table
maps to a key field (GroupIdentifier) in the Attribute
Groups table.
Each Attribute Values instance shall map to an instance in
the Attribute Groups table.
A foreign key (NewId) in the Attr Old New Map table maps
to the key field (GroupIdentifier) in the Attribute Groups
table.

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3.7

27

Attribute Values Table


The Attribute Values table allows each Attribute to be associated with an Attribute
Group. The Attribute Values table lists all Attribute variables, assigns each a unique
Attribute formula (UNIQUE ATTRFORM), and associates it with the appropriate Attribute
Group. The table indicates whether the Attribute is a core condition or if it is the default
value for the group.

3.7.1 Structure
Table 22 Attribute Values Table [RT053]
Field
Type

Field
Size

Text

Text
Text

5
50

Yes/No

n/a

DEFAULT

Yes/No

n/a

Retire Date

Text

11

old formula

Text

Field Name
UNIQUE
ATTRFORM
ATTRGRP
Attribute Text
CORE
CONDITION

Description of Information in this Field


Key field that uniquely identifies the Attribute Value as a
combination of group and value.
Foreign key to the Attribute Groups table.
Text description of the Attribute Value.
A yes/no field that indicates if the value is a core condition
value.
A yes/no field that indicates if the value is the default
value for the Attribute Group.
Date on which the Attribute Value was retired. Format is
DD MMM YYYY. The field is not populated for active
codes.
Previous identifier of the Attribute Value. This
corresponds to the unique identifier from the original
Attribute table.

Table 23 Examples of Attribute Values Table


UNIQUE
ATTRFORM
V0001011
V0001012
V0001013

ATTR
GRP
V0001
V0001
V0001

Attribute Values Table Excerpt


CORE
Attribute Text
DEFAULT
CONDITION
CP2D/450mL/refg
Yes
No
CP2D/500mL/refg
Yes
No
CP2D/XX/refg
Yes
No

V0001014

V0001

CP2DA/450mL/ refg

2014 ICCBBA All rights reserved

Yes

No

Retire
Date

13 DEC
2011

old
formula
E@11
E@12
E@13
E@14

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28

3.7.2 Related Tables


Table

Product Attribute
Map

Relationship to Attribute Values Table


A foreign key (attributevalue) in the Product Attribute Map
table maps to a key field (UNIQUE ATTRFORM) in the
Attribute Values table.
Each Product Attribute Map instance shall map to an
instance in the Attribute Values table.

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Product Description Code Database v6.0.0

3.8

29

Product Description Codes Table


The Product Description Codes table lists Product Descriptions and assigns each a
unique code (PRODDESCRIPCODE) and a unique Product Formula. It takes the place
of the original Product Description table. The Product Description code plays a critical
role in product traceability and labeling.

3.8.1 Structure
Table 24 Product Description Codes Table [RT054]
Field Name

Field
Type

Field
Size

PRODDESCRIP
CODE

Text

Key field that uniquely identifies the


product.

Class Identifier

Text

Foreign key to the Classes table.

Modifier Identifier

Text

Foreign key to the Modifiers table.

PRODDESCRIP0

Text

254

CODEDATE

Text

11

PRODDESCRIP1

Text

254

RETIREDATE

Text

11

Product Formula

Text

255

PRODDESCRIP
CODEFORM

Text

65

2014 ICCBBA All rights reserved

Description of Information in this Field

Text description of the product including


Modifier(s), Class, and Attribute Value(s).
Date the product was entered into the
database. Format is DD MMM YYYY.
Blank field for use at the national level.
Date on which the Product Description
code was retired. Format is DD MMM
YYYY. The field is not populated for active
codes.
Formula derived from Class, Modifier, and
Attribute Value identifiers.
Previous formula of the Product
Description. This corresponds to the
product formula from the original Product
Description table.

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Product Description Code Database v6.0.0

30

Table 25 Example of Product Description Codes Table


Product Description Codes Table Example
PROD
DESCRIP
CODE

Class
Identifier

Modifier
Identifier

E2684

C0004

M0008

Thawed PLASMA|
CPD/XX/refg

19
JUL
1996
17
JUL
2007

PRODDESCRIP0

S1122

C0045

M0000

HPC, MARROW|
NS/XX/<=-150C|10%
DMSO|Cryopreserved

T0332

C0216

M0000

TENDON, GRACILIS
|Frozen|Antibiotics

X0004

C0283

M0000

SOLVENT DETERGENT
POOLED PLASMA
|NS/NS/<=-18C|AB

V0003

C0278

M0000

CORNEA|Right
|Hypothermic storage

M0001

C0022

M0000

HUMAN MILK|<=-30C|
Pasteurized|
For nutritional use

2014 ICCBBA All rights reserved

CODE
DATE

14
SEP
2012
01
FEB
2008
10
AUG
2012
14
SEP
2012

PROD
DESCRIP1

RETIRE
DATE

Product
Formula
C0004-M0008V0001006
C0045-M0000V0002029V0045003V0050005
C0216-M0000V0061002V0066007
C0283-M0000V0003001V0076005
C0278-M0000V0070003V0071003
C0022-M0000V0026003V0027003V0028003

PROD
DESCRIP
CODEFORM
E018E@06

S001S@29
SG3SL5

T298TT2TY7
X001X@01
XA5
V001VC3VD3

M001MA3MB3
MC3

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31

3.8.2 Related Tables


Table

Product Attribute
Map

Relationship to Product Description Codes Table


A foreign key (proddescripcode) in the Product Attribute
Map table maps to a key field (PRODDESCRIPCODE) in
the Product Description Codes table.
Each Product Attribute Map instance shall map to an
instance in the Product Description Codes table.

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Product Description Code Database v6.0.0

32

Mapping Tables in the Database

Some of the database tables do not provide any additional data codes or formulas but are
needed for creating associations (or maps) between tables.

4.1

Modifier Category Map Table


The Modifier Category Map table creates the association between Modifiers and their
appropriate Categories. The association is created by mapping the Category number
identifier to Modifier identifiers. The Modifier Category Map table has an entry for each
Category-Modifier combination in use. The same Modifier can apply to multiple
Categories. A single Category can also have multiple Modifiers.

4.1.1 Structure
Table 26 Modifier Category Map Table [RT055]

Modifier

Field
Type
Text

Field
Size
5

Category

Number

n/a

Field Name

Description of Information in this Field


Foreign key to the Modifiers table.
Foreign key to the Categories table.

Table 27 Example of Modifier Category Map Table


Modifier Category Map Table Example
Modifier
Category
M0001
1
M0001
2
M0008
4
M0023
2
M0040
3

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Product Description Code Database v6.0.0

4.2

33

Product Attribute Map Table


The purpose of this table is to provide a mechanism for identifying any trends or
commonalities in products of interest during biovigilance efforts. It contains a field for the
Product Description code and a field for Attribute Values. This table lists and associates
each Product Description code with pertinent Attribute Values.

4.2.1 Structure
Table 28 Product Attribute Map Table [RT056]
Field Name

Field
Type

Field
Size

proddescripcode

Text

Foreign key to the Product Description Codes


table.

attributevalue

Text

Foreign key to the Attribute Values table.

Description of Information in this Field

Table 29 Example of Product Attribute Map Table


Product Attribute Map Table Example
proddescripcode
attributevalue
E0002
V0001001
E0002
V0011002
S1379
V0002030
S1379
V0046002
S1379
V0051002
S1379
V0055006

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Product Description Code Database v6.0.0

4.3

34

Attr Old New Map Table


The purpose of this table is to provide interim support of the old Attribute table by
mapping the Attribute Group codes in the old Attribute table to the Attribute Group codes
in the new Attribute Groups table.

4.3.1 Structure
Table 30 Attr Old New Map Table [RT057]

NewId
OldId
GrpName

Field
Type
Text
Text
Text

Field
Size
5
2
50

RETIREDATE

Text

11

Field Name

Description of Information in this Field


Foreign key to the Attribute Groups table.
Foreign key to the original Attribute table.
Text description of the Attribute Group.
Date on which the Attribute Group was retired.
Format is DD MMM YYYY. The field is not
populated for active codes.

Table 31 Example of Attr Old New Map Table


NewId
V0001
V0023
V0041
V0043
V0066

Attr Old New Map Table Example


OldId
GrpName
RETIREDATE
E@
Core Conditions
EM
Platelet Count
01 SEP 2009
SC
Preparation
01 MAR 2008
SE
Manipulation
TY
Pathogen Reduction

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