1 ISBT-128: It’s Finally Happening! KABB Spring Meeting March 10, 2007 Debra Bowman, MT(ASCP)SBB Quality Assurance Director Kentucky Blood Center

2 What Is It All About? The International Society for Blood Transfusion (ISBT) has developed a replacement for the ABC Codabar symbology which is currently used to label blood components.

3 How Long Have We Been Talking About This? FOR YEARS!!!!!! In 1997 AABB hosted a workshop to discuss implementation issues. AABB had standard requiring implementation that was later rescinded. Now AABB requires implementation by May 1, 2008

4 What Is It All About? ISBT 128 is a uniform labeling standard for blood components designed to capture information regarding identification and content of blood and blood products and to make that information universally accessible to the international blood banking community.

5 What Is It All About? The new ISBT 128 bar code symbology was designed to capture additional and more complex information within the bar code. The technology was developed through international consensus and allows for world wide standardization of information for labeling and data exchange.

6 What Is It All About? It is an internationally agreed upon information technology standard that includes specifications for labeling of blood components and for data transfer. ISBT 128 will be maintained through the International Council for Commonality in Blood Bank Automation (ICCBBA).

7 Why? The current Codabar technology has reached its limit of usefulness in a world of increasingly complex information technology. Today’s world is one where there is increased globalization.

8 Why? It is common for blood centers to sell products in the global market. During times of disaster, blood products may be shared around the world.

9 What Are the Advantages? Allows for more complex information to be encoded. Is more secure because it has 3 self checking features per character. Misscans are extremely rare. Provides uniform label format.

10 Advantages Provides unique donation ID number world wide. (DIN- Donation Identification Number) Allows for expanded description of product codes and future expansion. Captures special test information. Enhanced tracability features.

11 Advantages Can be used with RIF technology. Double density coding. No hand written data on labels. Decreased inventory of pre-printed labels. Decreased label stress testing. More efficient label inventory management.

12 ISBT 128 Standard Provides standard layout of blood product label. Defines data identifiers for the bar code used in blood, tissue, stem cell labeling and data transfer.

13 ISBT 128 Standard Defines data structures that carry information. Defines technical details for the bar code. Defines concatenation principles. Includes tables of definitions. Identifies ICCBBA as the authority.

14 US Authorities FDA approved and provided guidance in the U.S. Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 2.0.0, published in the Federal Register in November 2005.

15 US Authorities 21 CFR (c) 13 took effect on April 26, 2005 and requires blood banks to have certain information in machine readable format on the labels, including facility identifier, donor ID, product code, and ABO/Rh of the donor.

16 US Authorities AABB in the Association Bulletin # established a May 1, 2008 implementation deadline for accredited blood centers and hospital transfusion services.

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18 Visual Differences Donation Identification Number (DIN) will be longer – 13 characters. Product codes will be different and will include donation types and splits. Printed product description will be different. Expiration date will be in different location and will be eye-readable as 15 NOV Labels will all be black and white. No color.

19 Data Identifiers Data identifiers allow software to identify the contents of the data stream and validate that it belongs in the field intended. Data cannot be entered into the wrong field.

20 Data Identifiers Allow data to be entered into the correct field no matter what order it is entered. Allows data to be concatenated which means that two related bar codes are read at one time.

21 Check Digits Uses Check digits on number series Donor Identification Number (DIN) Patient medical record numbers where 9 is calculated from the other numbers in the set. Get error message for invalid entry.

22 Credit These next slides are from the November 15, 2006 AABB Audioconference because “it doesn’t get any better than this!” >>>>>>>>>>

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57 Example of Use With Patient Identification

58 How Do Hospitals Get Ready? Check with your blood supplier to see when their implementation date is. Most blood centers will work with hospital customers to help them prepare.

59 How Do Hospitals Get Ready? Gather educational resources. FDA Guidance at ISBT Code 128 Implementation Plan at aabb.org General information, technical information, registration information, registered vendor list at ICCBBA.org

60 How Do Hospitals Get Ready? Register with ICCBBA if your transfusion service is going to modify products and apply ISBT 128 labels. Note: Registration costs $200 initially and $100 annually if you do not collect products.

61 How Do Hospitals Get Ready? Check with your computer software vendor to make sure your software is ISBT 129 compatible. Check your scanners to make sure they can read ISBT 128 labels.

62 How Do Hospitals Get Ready? Check your printers to make sure they can print ISBT 128 labels if you are going to modify products. (Will need to be 300 dpi.) Determine what labels you will need to print. Ex. Labels for pooling, leukoreducing or splitting products.

63 How Do Hospitals Get Ready? Form an implementation team. Create an implementation plan, using the aabb plan as a guide. Budget for and purchase any software or hardware that you do not currently have.

64 How Do Hospitals Get Ready? Determine what forms will need to be revised. Determine which SOP’s will need to be revised. Determine what training will need to be done.

65 How Do Hospitals Get Ready? Determine what label supplies will need to be purchased. Review your processes and determine how they will change. Include such departments as nursing, OR, ER, and accounting in your planning.

66 How Do Hospitals Get Ready? Plan how to handle units during transition. Write validation plans for your hardware, software, labels, processes, SOP’s and training plans. Execute your validation.

67 Things to Consider Hospital billing systems will need to accommodate the ISBT 128 data structure and the new 13 digit DIN’s. Any manual forms will need to be updated to allow for longer unit numbers and product codes.

68 Things to Consider During transition you will need a way to handle both ISBT 128 and Codabar to account for frozen product that are still in inventory and labeled with Codabar. New expiration date location may be obscured by blood bag cup holders.

69 Things to Consider A blood center that has already implemented reported that their hospitals reported an average of: 45 hours planning and implementing. $1000 for scanners $300 for license fees

70 Summary It is finally happening! There are a lot of resources to help you make the transition. CHANGE IS GOOD!!!!!!!!!!!