ST 010 ISBT 128 Standard Product Description Code Database v6.0.0
ST 010 ISBT 128 Standard Product Description Code Database v6.0.0
ST 010 ISBT 128 Standard Product Description Code Database v6.0.0
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
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.
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Editor
Erwin Cabana
Lead Information Standard Specialist, ICCBBA
Standards Committee
John Armitage, Prof., BSc, PhD
United Kingdom
ICCBBA
Australia
ICCBBA
Jrgen Georgsen, MD
Denmark
Mario Muon, MD
Portugal
Australia
The Netherlands
Poland
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Table of Contents
1
Introduction ......................................................................................................................... 7
1.1
Purpose ....................................................................................................................... 7
1.2
Scope .......................................................................................................................... 7
1.3
1.4
1.5
1.6
Background.................................................................................................................. 7
1.7
2.1.1
2.2
2.2.1
2.3
2.3.1
2.4
Version Table..............................................................................................................15
3.1.1
Structure ..............................................................................................................18
3.1.2
Related Tables.....................................................................................................19
3.2
3.2.1
Structure ..............................................................................................................20
3.2.2
Related Tables.....................................................................................................20
3.3
3.3.1
Structure ..............................................................................................................21
3.3.2
Related Tables.....................................................................................................22
3.4
3.4.1
Structure ..............................................................................................................23
3.4.2
Related Tables.....................................................................................................23
3.5
3.5.1
3.6
Structure ..............................................................................................................25
3.6.1
Structure ..............................................................................................................26
3.6.2
Related Tables.....................................................................................................26
3.7
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3.7.1
Structure ..............................................................................................................27
3.7.2
Related Tables.....................................................................................................28
3.8
3.8.1
Structure ..............................................................................................................29
3.8.2
Related Tables.....................................................................................................31
4.1.1
4.2
4.2.1
4.3
Structure ..............................................................................................................32
Structure ..............................................................................................................33
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
2014 ICCBBA All rights reserved
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Figures
Figure 1 Entity Relationship Diagram .......................................................................................16
Figure 2 Entity Relationship Diagram Showing Example Instances ..........................................17
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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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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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1.7
1.
Version 1.0.0
Version 6.0.0
Chapter,
Section,
Table, or
Figure
Chapter,
Section,
Table, or
Figure
Throughout
Throughout
Change
Rationale
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10
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
ATTRVAR
ATTRNAME
@
@
@
00
01
02
Core Conditions
ACD-A/450mL/refg
ACD-B/450mL/refg
ATTRFORM
UNIQUE
ATTRFORM
E@00
E@01
E@02
RETIREDATE
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11
ATTRVAR
@
@
03
04
ATTRNAME
ATTRFORM
CPD/450mL/refg
CPD/500mL/refg
UNIQUE
ATTRFORM
E@03
E@04
RETIREDATE
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
MODIFIER
Text
35
CLASS
Text
36
NAME
Text
75
UNIQUE
NAMECODE
Text
11
RETIREDATE
Text
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12
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
2.3
Field Name
Field
Type
Field
Size
PRODDESCRIPCODE
Text
NAMECODE
Text
COMBATTRFORM
Text
60
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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14
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
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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
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16
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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17
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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
OldCode
Text
1
This is a temporary field for ICCBBA internal use to
support the upload of the old database into the new.
Cat No
1
2
3
4
5
6
7
8
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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19
Subcategories
Modifier Category
Map
Attribute Groups
Each Attribute Group instance shall map to an instance in
the Categories table.
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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
Subcategory
Category
Blood Components
Cellular Therapy
Tissues
Other Blood Products
Ocular
Other Therapies
Organs
Reproductive
1
2
3
4
5
6
7
8
Classes
Each Classes instance shall map to an instance in the
Subcategories table.
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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
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
StructuredName
RETIRE
DATE
Subcategory
1
1
1
1
1
1
1
1
1
1
1
1
1
1
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22
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
Class Modifier
Combinations
Product Description
Codes
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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
RETIREDATE
Class Modifier
Combinations
Product Description
Codes
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Table
Modifier Category
Map
24
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3.5
25
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
M0000
M0007
M0008
C0004
M0009
C0004
M0010
C0004
M0013
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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3.6
26
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
Category
1
1
1
1
1
Attribute Values
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3.7
27
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
ATTR
GRP
V0001
V0001
V0001
V0001014
V0001
CP2DA/450mL/ refg
Yes
No
Retire
Date
13 DEC
2011
old
formula
E@11
E@12
E@13
E@14
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28
Product Attribute
Map
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3.8
29
3.8.1 Structure
Table 24 Product Description Codes Table [RT054]
Field Name
Field
Type
Field
Size
PRODDESCRIP
CODE
Text
Class Identifier
Text
Modifier Identifier
Text
PRODDESCRIP0
Text
254
CODEDATE
Text
11
PRODDESCRIP1
Text
254
RETIREDATE
Text
11
Product Formula
Text
255
PRODDESCRIP
CODEFORM
Text
65
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30
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
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
Product Attribute
Map
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32
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
4.1.1 Structure
Table 26 Modifier Category Map Table [RT055]
Modifier
Field
Type
Text
Field
Size
5
Category
Number
n/a
Field Name
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4.2
33
4.2.1 Structure
Table 28 Product Attribute Map Table [RT056]
Field Name
Field
Type
Field
Size
proddescripcode
Text
attributevalue
Text
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4.3
34
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
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