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

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 Fax: +1.909.793.6214 E-mail: [email protected] Website: http://www.iccbba.org

Product Description Code Database v6.0.0 2

2014 ICCBBA All rights reserved 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.

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 country-specific 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.



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



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

2 Original Database Tables ...................................................................................................10 2.1 Attribute Table ............................................................................................................10

2.1.1 New Tables that Replace the Attribute Table .......................................................11 2.2 Class Table .................................................................................................................11

2.2.1 New Tables that Replace the Class Table ...........................................................12 2.3 Product Description Table ...........................................................................................12

2.3.1 New Tables that Replace the Product Description Table .....................................14 2.4 Version Table ..............................................................................................................15

3 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 Structure ..............................................................................................................25

3.6 Attribute Groups Table ................................................................................................26 3.6.1 Structure ..............................................................................................................26 3.6.2 Related Tables .....................................................................................................26

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



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

4 Mapping Tables in the Database ........................................................................................32 4.1 Modifier Category Map Table ......................................................................................32

4.1.1 Structure ..............................................................................................................32 4.2 Product Attribute Map Table .......................................................................................33

4.2.1 Structure ..............................................................................................................33 4.3 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



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



1 Introduction

1.1 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



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 Restructured Database Number of Class-Modifier Combinations per product Category: 999

Number of Classes: 9,999 Number of Modifiers: 9,999

Number of Attribute Groups per product Category: 26 Number of Attribute Groups: 9,999

Number of Attribute Values per group: 36 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.



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.

Version 1.0.0

Chapter, Section, Table, or Figure

Version 6.0.0

Chapter, Section, Table, or Figure

Change Rationale

1. Throughout Throughout

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.



2 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]

Field Name Field Type Field Size Description of Information in this Field

ATTRGRP Text 1 Identifier for Attribute Group. ATTRVAR Text 2 Identifier for Attribute variable within a group.

ATTRNAME Text 50 Description of the Attribute Group and variable (note: the group description is in the row with a variable value of zero).

ATTRFORM Text 3 Obsolete Field is depopulated. UNIQUE ATTRFORM Text 4

Unique identifier for the Attribute value combining the product type, Attribute Group, and variable.

RETIREDATE Text 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.

Table 3 Example Attribute Table

Attribute Table Excerpt

ATTRGRP ATTRVAR ATTRNAME ATTRFORM UNIQUE ATTRFORM RETIREDATE

@ 00 Core Conditions E@00 @ 01 ACD-A/450mL/refg E@01 @ 02 ACD-B/450mL/refg E@02



Attribute Table Excerpt

ATTRGRP ATTRVAR ATTRNAME ATTRFORM UNIQUE ATTRFORM RETIREDATE

@ 03 CPD/450mL/refg E@03 @ 04 CPD/500mL/refg E@04

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]


NAMECODE Text 3 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 4 Unique identifier for the Class/Modifier of product

RETIREDATE Text 11




Table 5 Example Class Table

Class Table Excerpt

NAMECODE MODIFIER CLASS NAME UNIQUE NAMECODE RETIREDATE

001 WHOLE BLOOD WHOLE BLOOD E001

002 RED BLOOD CELLS

RED BLOOD CELLS E002

003 Washed RED BLOOD CELLS

Washed RED BLOOD CELLS E003

004 Frozen RED BLOOD CELLS

Frozen RED BLOOD CELLS E004

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]


PRODDESCRIPCODE Text 5 The unique Product Description Code for the product.

NAMECODE Text 3 Obsolete Field is to be depopulated in the near future. COMBATTRFORM Text 60 Obsolete Field is depopulated.




PRODDESCRIP0 Text 254 The description of the product in structured format.

CODEDATE Text 11 The date the code was assigned. Format is DD MMM YYYY.

PRODDESCRIP1 Text 254 Field available for national descriptions, not populated by ICCBBA. PRODCODEFORM Text 50 Obsolete Field is depopulated.

PRODDESCRIPCODEFORM Text 65

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).

RETIREDATE Text 11




Table 7 Example of Product Description Table

Product Description Table Example PROD

DESCRIP CODE

NAME CODE

COMBATTRFORM

PROD DESCRIP0 CODEDATE PROD

DESCRIP1 PRODCODE

FORM PRODDESCRIP

CODEFORM RETIREDATE

E0023 001 WHOLE BLOOD |CPD/500mL/refg 19 JUL 1996 E001E@04

S1128 005 HPC, APHERESIS |Citrate/XX/ refg| Mobilized

17 JUL 2007 S005S@34SM2

T0293 311 MENISCUS, LATERAL |Frozen|Left

08 AUG 2011

T311TT2TV2

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.



2.4 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]

Table 9 Example of Version Table

Version Table Version Number Date

5.3.0 02 SEP 2014


Version Number Text 50 The version number of the product database. Date Text 11 The date issued. The format is DD MMM YYYY.



3 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



Figure 2 Entity Relationship Diagram Showing Example Instances



3.1 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

Field Type

Field Size Description of Information in this Field

Cat No Number n/a Key field sequence number. Category Text 255 Text description of the Category.

OldCode Text 1

Letter assigned to the first character of the Product Description code for that Category. 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

Categories Table Cat No Category OldCode

1 Blood Components E 2 Cellular Therapy S 3 Tissues T 4 Other Blood Products X 5 Ocular V 6 Other Therapies M 7 Organs N 8 Reproductive R



3.1.2 Related Tables

Table Relationship to Categories Table

Subcategories

A foreign key (Category field) in the Subcategories table maps to the key field (Cat No) in the Categories table. Each Subcategory instance shall map to an instance in the Categories table.

Modifier Category Map

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.

Attribute Groups

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



3.2 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 Number n/a Key field sequence number. Subcategory Text 255 Text description of the Subcategory.

Category Number n/a Foreign key to the Categories table.

Table 13 Example of Subcategories Table

Subcategories Table Subcat

No Subcategory Category

1 Blood Components 1 2 Cellular Therapy 2 3 Tissues 3 4 Other Blood Products 4 5 Ocular 5 6 Other Therapies 6 7 Organs 7 8 Reproductive 8


Table Relationship to Subcategories Table

Classes

A foreign key (Subcategory) in the Classes table maps to a key field (Subcat No) in the Subcategories table. Each Classes instance shall map to an instance in the Subcategories table.



3.3 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 Text 5 Key field Class number Cxxxx. ClassName Text 36 Text description of Class.

StructuredName Text 255 Structured description of Class. This field is not currently populated.

RETIREDATE Text 11 Date on which the Class was retired. Format is DD MMM YYYY. The field is not populated for active codes.

Subcategory Number n/a Foreign key to the Subcategories table.

Table 15 Example of Classes Table

Classes Table Excerpt

ClassIdentifier ClassName StructuredName RETIREDATE Subcategory

C0001 WHOLE BLOOD 1 C0002 RED BLOOD CELLS 1 C0003 FRESH FROZEN PLASMA 1 C0004 PLASMA 1 C0005 PLATELET-RICH PLASMA 1 C0006 PLATELETS 1 C0007 POOLED PLATELETS 1 C0008 CRYOPRECIPITATE 1

C0009 POOLED CRYOPRECIPITATE 1

C0010 GRANULOCYTES 1

C0011 POOLED GRANULOCYTES 1

C0012 GRANULOCYTES-PLATELETS 1

C0013 LEUKOCYTES 1 C0014 POOLED PLASMA 1



Classes Table Excerpt

ClassIdentifier ClassName StructuredName RETIREDATE Subcategory

C0015 PLATELET-RICH BUFFY COAT 1

C0016 POOLED PLATELET-RICH BUFFY COAT 1

C0017 LYMPHOCYTES 03 MAY 2010 1

C0018 MONOCYTES 03 MAY 2010 1

C0019 SERUM 1 C0020 POOLED SERUM 1

C0021 POOLED FRESH FROZEN PLASMA 1


Table Relationship to Classes Table

Class Modifier Combinations

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.

Product Description Codes

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.



3.4 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 Text 5 Key field Modifier number Mxxxx. ModifierName Text 255 Text description of Modifier.

RETIREDATE Text 11 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 RETIREDATE

M0000 M0001 Washed M0002 Frozen M0003 Frozen Rejuvenated M0004 Deglycerolized M0005 Deglycerolized Rejuvenated


Table Relationship to Modifiers Table

Class Modifier Combinations

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.

Product Description Codes

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.



Table Relationship to Modifiers Table

Modifier Category Map

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.



3.5 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]


ClassIdentifier Text 5 Key field Class number Cxxxx. Foreign key to Classes table.

ModifierIdentifier Text 5 Key field Modifier number Mxxxx. Foreign key to Modifiers table. Name Text 75 Text description of Class-Modifier combination.

RETIREDATE Text 11 Date on which the Class-Modifier combination was retired. Format is DD MMM YYYY. The field is not populated for active codes.

UNIQUE NAMECODE Text 4

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 Name RETIREDATE UNIQUE NAMECODE C0004 M0000 PLASMA E017 C0004 M0007 Apheresis PLASMA E014 C0004 M0008 Thawed PLASMA E018

C0004 M0009 Thawed Apheresis PLASMA E015

C0004 M0010 Liquid PLASMA E016

C0004 M0013 Liquid Apheresis PLASMA E041



3.6 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]


GroupIdentifier Text 5 Key field, sequentially assigned group number in the format Vxxxx. GroupName Text 100 Text description of the Attribute Group.

RetireDate Text 11 Date on which the Attribute Group was retired. Format is DD MMM YYYY. The field is not populated for active codes.

Category Number n/a Foreign key to the Categories table.

Table 21 Example of Attribute Groups Table

Attribute Groups Table Excerpt GroupIdentifier GroupName RetireDate Category V0021 Method of Treatment 1 V0022 Hematocrit 1 V0023 Platelet Count 01 SEP 2009 1 V0024 Monitoring 1 V0025 Donor Exposure 1


Table Relationship to Attribute Groups Table

Attribute Values

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.

Attr Old New Map A foreign key (NewId) in the Attr Old New Map table maps to the key field (GroupIdentifier) in the Attribute Groups table.



3.7 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]


UNIQUE ATTRFORM Text 8

Key field that uniquely identifies the Attribute Value as a combination of group and value.

ATTRGRP Text 5 Foreign key to the Attribute Groups table. Attribute Text Text 50 Text description of the Attribute Value. CORE CONDITION Yes/No n/a

A yes/no field that indicates if the value is a core condition value.

DEFAULT Yes/No n/a A yes/no field that indicates if the value is the default value for the Attribute Group.

Retire Date Text 11 Date on which the Attribute Value was retired. Format is DD MMM YYYY. The field is not populated for active codes.

old formula Text 8 Previous identifier of the Attribute Value. This corresponds to the unique identifier from the original Attribute table.

Table 23 Examples of Attribute Values Table

Attribute Values Table Excerpt UNIQUE

ATTRFORM ATTRGRP Attribute Text

CORE CONDITION DEFAULT

Retire Date

old formula

V0001011 V0001 CP2D/450mL/refg Yes No E@11 V0001012 V0001 CP2D/500mL/refg Yes No E@12 V0001013 V0001 CP2D/XX/refg Yes No E@13

V0001014 V0001 CP2DA/450mL/ refg Yes No 13 DEC 2011 E@14




Table Relationship to Attribute Values Table

Product Attribute Map

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.



3.8 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]


PRODDESCRIP CODE Text 5

Key field that uniquely identifies the product.

Class Identifier Text 5 Foreign key to the Classes table.

Modifier Identifier Text 5 Foreign key to the Modifiers table.

PRODDESCRIP0 Text 254 Text description of the product including Modifier(s), Class, and Attribute Value(s).

CODEDATE Text 11 Date the product was entered into the database. Format is DD MMM YYYY. PRODDESCRIP1 Text 254 Blank field for use at the national level.

RETIREDATE Text 11

Date on which the Product Description code was retired. Format is DD MMM YYYY. The field is not populated for active codes.

Product Formula Text 255 Formula derived from Class, Modifier, and Attribute Value identifiers.

PRODDESCRIP CODEFORM Text 65

Previous formula of the Product Description. This corresponds to the product formula from the original Product Description table.



Table 25 Example of Product Description Codes Table

Product Description Codes Table Example PROD

DESCRIP CODE

Class Identifier

Modifier Identifier PRODDESCRIP0

CODEDATE

PROD DESCRIP1

RETIRE DATE

Product Formula

PROD DESCRIP

CODEFORM

E2684 C0004 M0008 Thawed PLASMA| CPD/XX/refg

19 JUL 1996

C0004-M0008-V0001006 E018E@06

S1122 C0045 M0000 HPC, MARROW| NS/XX/




Table Relationship to Product Description Codes Table

Product Attribute Map

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.



4 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 Text 5 Foreign key to the Modifiers table. Category Number n/a 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



4.2 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]


proddescripcode Text 5 Foreign key to the Product Description Codes table. attributevalue Text 8 Foreign key to the Attribute Values table.

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



4.3 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 Text 5 Foreign key to the Attribute Groups table. OldId Text 2 Foreign key to the original Attribute table. GrpName Text 50 Text description of the Attribute Group.

RETIREDATE Text 11 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

Attr Old New Map Table Example NewId OldId GrpName RETIREDATE V0001 E@ Core Conditions V0023 EM Platelet Count 01 SEP 2009 V0041 SC Preparation 01 MAR 2008 V0043 SE Manipulation V0066 TY Pathogen Reduction

1 Introduction1.1 Purpose1.2 Scope1.3 Intended Audience1.4 Normative References1.5 Other Reference1.6 Background1.7 New in this Version

2 Original Database Tables2.1 Attribute Table2.1.1 New Tables that Replace the Attribute Table

2.2 Class Table2.2.1 New Tables that Replace the Class Table

2.3 Product Description Table2.3.1 New Tables that Replace the Product Description Table

2.4 Version Table

3 New Database Tables3.1 Categories Table3.1.1 Structure3.1.2 Related Tables

3.2 Subcategories Table3.2.1 Structure3.2.2 Related Tables

3.3 Classes Table3.3.1 Structure3.3.2 Related Tables

3.4 Modifiers Table3.4.1 Structure3.4.2 Related Tables

3.5 Class Modifier Combinations Table3.5.1 Structure

3.6 Attribute Groups Table3.6.1 Structure3.6.2 Related Tables

3.7 Attribute Values Table3.7.1 Structure3.7.2 Related Tables

3.8 Product Description Codes Table3.8.1 Structure3.8.2 Related Tables

4 Mapping Tables in the Database4.1 Modifier Category Map Table4.1.1 Structure

4.2 Product Attribute Map Table4.2.1 Structure

4.3 Attr Old New Map Table4.3.1 Structure

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

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