ICCBBA, Inc

Chapter or Section

Change

Rationale

Version 2.0.0 United States Industry Consensus Standard for Uniform Labeling of Blood and Blood Components, November 2005 vs. Version 1.2.0, November 1999

1

Introduction

Added Warranty and Liability information

Legal requirements

2

Introduction

Added definitions section

Standardize use of terminology

3

Introduction

Added illustration of terms used in text

Clarify terminology

4

1

Deleted names of documents that are no longer available.

Accurately reflect available resources

5

2

Added historical information about Version 1.2.0 of this document

Bring reader up-to-date with history of this US Industry Consensus document

6

3

Added Table 2 to define “Special Purpose” codes for the ABO/Rh data structure

Allows for more flexibility in the use of the standard

7

3

Renumbered Table 2 to Table 3.  Added n-3 (emergency release) donation type

Consistent with information found in 3.5.3.1.2

8

3.3

Deleted information designating national groups responsible for definition of tables that have limited use

Most tables are now internationally defined.

9

3.5.1

Explained how data structures may be used with technologies other than linear bar codes

Clarification

10

3.5.2.1.3

Allowed for the use of flag characters in the Donation Identification Number data structure

Allows for more flexibility in the use of the standard

11

3.5.3.1.2

Allowed for use of n-3 (For Emergency Use Only) donation type in the ABO/Rh data structure.

Allows for more flexibility in the use of the standard

12

3.5.3.1.2

Indicated that special labeling (“For Designated Recipient Only”) in the Upper Right Quadrant is used when the unit cannot be crossed over for use by another recipient

Clarification

14

3.5.3.1.3

Deleted former section 3.5.3.1.3 (which included definitions) and replaced it with instructions for labeling of directed units that can be crossed over for use by another recipient. 

Include most definitions in a glossary at the beginning of the document.  Standardize the labeling of directed units.

15

3.5.5.2

Changed name of “Apheresis:  Additional Information” to “Apheresis and Container—Additional Information.

Better reflect information contained within this group.

16

3.5.4.1

Changed wording from discouraging the use of 2359 in the bar code text when a product is not time dependent to disallowing it.

To create standardization in expressing time of expiration when the product is not time dependent.

17

3.5.5.2

Changed the name of “Pools—Additional Information” to “Dosage—Additional Information.”

Better reflect information contained within this group.

18

3.5.5.2

Added three attribute groups (Hematocrit, Platelet Count and Monitoring).

Consistent with International agreement

19

3.5.5.2

Allowed for the use of A0000-D9999 product codes for “local” products.

Provide a mechanism to label products that are not standardized

20

3.5.5.3.3

Allowed for some therapeutic collections not to be labeled as therapeutic if facility has FDA approval to do so

Consistent with FDA guidelines

21

3.5.5.2

Added a note explaining the use of division/split codes versus multiple container codes

Clarification

22

3.5.5.3

Deleted reference to maintenance by ICCBBA, Inc of a column in the Product Description data base defining the US terminology for a given component

There may be alternate means to provide this information in the future.

23

3.5.5.3.3

Omitted the use of L donation type (for directed recipient use only, limited exposure)

Not a common labeling need in the US

24

3.5.5.3.4

Allow facilities to print division information in eye-readable form beneath the storage temperature

More obvious designation of divisions for users

25

3.5.6

Deleted need for an extra data structure for anticoagulant information

Standardized with international requirements.  This information is contained within existing data structures.

26

3.5.7

Allowed use of internationally-defined Special Testing codes

International standardization

27

3.5.8

Allowed for use of red cell antigen data structure

International standardization

28

3.5.9

Allowed for use of Serologically-Determined Platelet HLA and Platelet-Specific Antigens

International standardization

29

4.1.2

Moved definitions to glossary, renumbered remaining sections in Chapter 4

30

4.1.5.1 (renumbered to 4.1.4.1)

Designated upper left quadrant for Collected and Processed by information for collection facility.  Reserved lower right quadrant for identification of a facility that modifies the product.

Ensure space for identification of facilities that modify a product.

31

4.5

Updated information to include FDA requirement to use machine readable labels

Consistent with CFR

32

5

Deleted table of contents within this section

Incorporated into general table of contents

33

5

Deleted bar code that specified anticoagulant in illustrations

Consistent with information in 3.5.6

34

5

Included eye-readable text for manufacturer information on platelet base labels

Consistent with other labels

35

5

Added an example of a simplified Intended Recipient Information label

Greater flexibility

36

5

Gave examples of how division and container information can be included in eye-readable form beneath the storage temperature information.

More obvious designation of containers and divisions for user

37

5

Moved examples of recovered and source plasma labels to be with other product labels

Keep product code label examples together.

38

5

Added examples of special testing and red cell antigen labels

Clarification

39

5.2

Added requirement to print class, modifiers and attributes in upper case letters

Clarification.  While this was shown in the examples, it had not been stated clearly.

40

6.3

Deleted description of Container Manufacturer Identification code; renumbered remaining sections of this chapter

No longer needed

41

7

Updated references

42

Appendix 1

Renamed Appendix A

43

Appendix A

Removed the requirement to include the original collection volume on Washed, Frozen, Rejuvenated and Deglycerolized Red Blood Cells.  Required the actual volume.

Consistent with CFR.

44

Appendix 2

Renamed Appendix B

45

Appendix B

Moved “Apheresis” to the Modifier column.

Consistent with database

46

Appendix B

Added Liquid Apheresis Plasma, Washed Apheresis Red Blood Cells, Frozen Apheresis Red Blood Cells, Deglycerolized Apheresis Red Blood Cells, Rejuvenated Apheresis Red Blood Cells, Frozen Rejuvenated Apheresis Red Blood Cells and Deglycerolized Rejuvenated Apheresis Red Blood Cells

Additions to database

47

Appendix 3

Renamed Appendix C

48

Appendix C

Noted that it is not necessary or recommended to include the actual platelet count on a leukocyte reduced product

Consistent with US labeling requirements

49

Appendix C

Deleted “supernatant removed”

Supernatant reduced is the preferred terminology in the US

50

Appendix C

Changed name of “Apheresis:  Additional Information” group to “Apheresis and Container:  Additional Information”

Better description of group

51

Appendix C

Changed name of “Pools:  Additional Information” to “Dosage: Additional Information”

Platelet counts are used for both pools and apheresis products

52

Appendix C

Added Platelet Count and Monitoring Groups

Additions to database

53

Appendix 4

Renamed Appendix D.

54

Appendix D

Moved label examples to Chapter 5

Keep most label examples together.

55

Appendix D

Deleted option for L donation type.  Added option for s donation type.

Reflecting usage in the US

56

Appendix E

Renamed Appendix 5

57

Appendix 6

Deleted

Information found in international documents

58

Appendix 7

Deleted.

No longer used.

Chapter or Section

Change

Rationale

Version 2.0.0, November 2005 vs. Version 2.0.0, February 2005

1

Throughout

The term “chapter” replaces the previously used term of “section” here and throughout the document

Terminology change to reflect length and complexity of document

2

Pg. iv

Warranty/liability page inserted

Legal requirement

3

Definitions

Added definitions for: attribute, autologous collection, class, core conditions, data characters, data content, data identifier, flag character, and modifier.

Revised definitions for: designated, eye readable text, bar code text.

Clarification

4

Abbreviations and acronyms

Omitted:  AABB

AABB is the name of the organization now, not an acronym

6

Preface

Deleted wording that suggests FDA is currently revising the CFR to reflect ISBT 128 product names.

While this is still planned, it is not in the immediate future.

7

Preface

2nd paragraph, 1st sentenced – added “…for those who choose to use it.”

To ensure it is clear that FDA does not require ISBT 128

8

Preface

Updated references

To include current documents

9

Background and History

Specifically mentioned FDA regulation pertaining to machine readable labels.

Clarified the regulation requires machine readable labels rather than bar codes

10

3.5.1

Specific information about the Donation Identification number omitted

Covered in Section 3.5.2.

11

3.5.2

αpppp – no longer represents country designation, only collection facility

Since Facility Identification Numbers were issued, some countries have split and others have merged.  This makes the original country designations invalid.  These codes represent unique codes for each facility and do not necessarily reflect a country of origin.

12

3.5.2

The term “check character” replaces the previously used term of “check digit”

The character can be either a number of letter.

13

3.5.2

Added to the last paragraph: “Flag characters are to be used in process control; it is not intended that they be recorded as part of the Donation Identification Number.”

Clarification.

14

3.5.2.1.5

Addition of 14 month rationale

Clarification.

15

3.5.3

Replaced “For Research Only” with “FOR LABORATORY RESEARCH USE ONLY”

New wording reflects FDA requirement.

16

3.5.3.1

Omitted the Note indicating additional information about autologous and directed units would follow

Not necessary

17

3.5.3.1

Added a reference to the para/Bombay illustrations in chapter 5

Clarification.

18

3.5.3.1.1

Added the clause, “unless the product is not suitable for transfusion.”

To allow non-collection facilities to deface the ABO label if the units is quarantined.

19

3.5.3.1.2

“Allogeneic Donation” is removed from the examples

Allogeneic donations are the default type and not specifically encoded in the ABO/Rh data structure

20

3.5.4.1

Changed wording from discouraging the use of 2359 in the bar code text when a product is not time dependent to disallowing it.

To create standardization in expressing time of expiration when the product is not time dependent.

21

Table 2

Replaced the term “Pooled Platelets” with “Pooled Products”

To allow pooled codes to be used for pooled cryoprecipitated AHF

22

3.5.3.1.3

Specified upper right quadrant labeling of directed donations

Clarification

23

3.5.3.1.3

Omitted the clause “and the removal should be noted in the records of the facility” from the last sentence.

This is a facility decision.

24

3.5.3.1.4

Omitted this section

The terms defined in this section were moved to the Definitions section

25

3.5.5

α0000 – α can be E or F

To allow for expansion of blood component product codes.

26

3.5.5

Omitted the reference to the glossary in ISBT 128 Standard: Blood Components—Coding, Definitions and Examples.  Omitted reference to Technical Bulletin 4.

Added to glossary of this document

27

3.5.5.1

Added the definition of Modifier

Clarification

28

3.5.5.2

Omitted the designated letter code for each attribute

Unnecessary detail

29

3.5.5.2

Replaced attributes:  “Volume” with “Final Content” and “Pools” with “Dosage”

Added attributes:  Platelet Count, Monitoring

Consistent with product code description database terminology

30

3.5.5.2

Replaced the reference of document ISBT 128 Standard: Blood Components—Coding, Definitions and Examples with reference to the document ISBT 128 Standard: Product Coding—Bounded Lists and Definitions

This document was renamed when it was updated.

31

3.5.5.2

In the first Note – added the sentence “These products may be shipped locally, but may not be shipped interstate.”

To allow products with local product codes to be shipped outside the processing facility to local facilities.  However, because these products would not be FDA licensed, they may not be shipped interstate.

32

3.5.5.2

In the second Note – omitted the reference to ISBT 128 Standard: Blood Components—Coding, Definitions and Examples

This document was renamed when it was updated.

33

3.5.5.3

Deleted reference concerning the AABB Information Systems Committee reviewing product code requests

Contained in Section 3.5.5.4

34

3.5.5.3.1

Deleted details of labeling of source and recovered plasma

Actual rules are more complex than indicated.  FDA regulations should be consulted for this information

35

3.5.5.3.3

Reworded section on mandatory and optional uses of donation type

Clarification

36

3.5.5.3.3

Added example of eye readable text for directed donations encoded in the product code data structure

Clarification

37

Formerly 4.1.2

Omitted this section.  Renumbered remainder of sections in Chapter 4.1.

Definitions provided in this section of the February 2005 version is now in the Definitions section of the November 2005 version

38

4.1.4 (formerly 4.1.5)

Omitted 1st Note that reads, “Special Testing bar codes are optional”

Interrupted flow of discussion

39

4.1.4 (formerly 4.1.5)

Omitted the paragraph concerning the product descriptions on the base label

With the addition of the Manufacturer’s Data File, base labels may no longer include this information

40

4.1.4 (formerly 4.1.5)

Volunteer/Paid Donor statement was added to the list of Intermediate importance when labeling blood products

FDA requires this text to be equal in prominence to Product Code

41

4.1.4.1 (formerly 4.1.5.1)

Specified that the US license number may be placed in either the Upper Left or Lower Left Quadrant

Based on comments received during the comment period

42

4.1.4.2

Added that the US license number may appear in either the upper left or lower left quadrant, but NOT in both places

FDA will not permit US license number to appear in two places on the label.

43

4.2

Omitted the first paragraph from the February 2005 version

Comments received indicated the paragraph was confusing

44

5

Deleted wording that suggests FDA is currently revising the CFR to reflect ISBT 128 product names.

While this is still planned, it is not in the immediate future.

45

5.2

Added requirement to print class, modifiers and attributes in upper case letters

Clarification.  While this was shown in the examples, it had not been stated clearly.

46

5.2

Exception to the general rule – “intended use information (in the form of a cautionary statement such as CAUTION: FOR USE IN MANUFACTURING NON-INJECTABLE PRODUCTS ONLY) will be printed at the same size as the proper name and on the lines immediately following the proper name.”

FDA requirement

47

Formerly 5.2.1

Omitted information about labeling pooled products

Covered in Section 4.4

48

Section 5.3

Removed tables of contents within the section; added titles to each figure

Added figures to general table of contents

48

Figures 10-13

Deleted manufacturer’s information bar code

US has adopted the use of the international manufacturer’s information bar codes

50

Figure 15-17

Dashed lines separating the quadrants were omitted

These dotted lines should not be found on the final label; comments indicated the example was confusing

51

Figure 18 and 19

Actual bar codes are now shown

Greater accuracy

52

Figure 20

“Hospital” was changed to “Facility” on example label; a second label was also added.  Added note that these were examples and other designs could be used.

“Facility” is more generic; Some facilities wanted less information on the intended recipient’s label.  To allow for other variations for this label.

53

Figure 21

Actual bar codes are now shown

Greater accuracy

54

Figure 23

Label examples were updated. 

• An example showing bar code text for divisions was included. 
• Residual leukocyte count was omitted.
• An example of bar code text on an apheresis container was included
• Examples for recovered and source plasma were added to this section (rather than being in a separate section)

Clarification

55

Figure 25

Therapeutic label contains new information

Per FDA requirements

56

Figure 26

Special Testing and Red Cell Antigen sample labels were added

Clarification.

57

6.2

Reference to ISBT 128 Standard: Technical Specification replaces the reference to ISBT 128 Standard: Blood Components—Coding, Definitions and Examples

Reflect where the information is now found.

58

7.1

Newer versions are referenced and new titles are added

Updated references.

59

Appendix A (pg 61)

Used an example that included a modifier and more attributes

Illustrated more labeling information

60

Appendix A (pg 61)

“SUPERNATANT REMOVED” was replaced by “DEGLYCEROLIZED”

Supernatant removed is not a preferred attribute in the US

61

Table 4

Deleted reference to nominal collection volume on Washed, Frozen, Rejuvenated and Deglycerolized Red Blood Cells

The XX attribute will be used for these products and actual volumes will be printed/written on the labels in the US

62

Table 4

Deleted “if frozen” note on Pooled Cryoprecipitated AHF

This is part of the product definition.

63

Table 5

Explained when apheresis plasma is classified as source versus recovered plasma

Per new FDA definitions

64

Table 5

“Pooled” is now part of a Component Class and no longer a Modifier

Consistent with Product Code Description database

65

Table 5

The last seven items were added

Reflecting additions to the data base

66

Table 6

Added more information for recovered and source plasma

Per discussions with the FDA

67

Table 6

Recommended against including Residual Leukocyte count information

Not required in the US and some printers have problems printing this information to the satisfaction of the FDA

68

Table 6

Replaced “SUPERNATANT REMOVED” to “SUPERNATANT REDUCED”

Reflect appropriate terminology for US usage

69

Table 6

Added information about text for Final Content, Low Volume section

Clarification

70

Table 6

Allowed “1st Container, 2nd Container, etc.” to be printed as bar code text

Per comments received from users

71

Table 6

“Dosage: Additional Information”,  “Platelet Count” and “Monitoring” sections

Reflects update to the data base

72

Table 7

Omitted the default character of 0

In the US, the label must indicate if products for transfusion are from paid or volunteer donors

73

Table 7

Replaced “RESEARCH” with “FOR LABORATORY RESEARCH USE ONLY”

Wording acceptable to the FDA

74

Table 7

Added sixth position data characters: d, 2, 3, 4, 5

Acceptable for us in the US

75

Formerly Appendix F

Omitted

This section was incorporated in Chapter 5

76

Formerly Appendix G

Omitted

This section was incorporated in Chapter 5