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Introduction to Barcoding Who is Using ISBT 128? Frequently Asked Questions Technical Advisory Groups Cellular Therapy Home Page
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Frequently Asked QuestionsGo to Global ISBT 128 Frequently Asked Questions Go to U.S. ISBT 128 Frequently Asked Questions
Global ISBT 128: Frequently Asked Questions1. Does my facility need to register with ICCBBA? 2. Where will I find a step-by-step process for registration with ICCBBA? 3. If the name of my facility changes, will I need to re-register with ICCBBA? 4. If my software vendor has an ISBT 128 package available, why do I need to register with ICCBBA? 5. Why are there so many more ISBT 128 product codes than Codabar codes? 6. Where do I find the product codes that I need? 7. How do I obtain a new product code? 9. Is the use of the check character during keyboard entry of the Donation Identification Number required every time I type it in? 10. I heard there were "flags" used in the Donation Identification Number. What do you mean by flags and do I need to use the flags? 11. Where can I find ISBT 128 labels for validation? 12. My current software already supports ISBT 128 and it is validated for everything but scanning ISBT 128 bar codes. Do I need to do anything 13. Will ISBT 128 labels be readable with most bar code reading technology? 14. Is the use of concatenation required? 15. We are having difficulty getting our scanner to concatenate and read ISBT 16. I am currently using the ABC Codabar bar codes and have been reasonably satisfied. Why should I change to ISBT 128? 17. Why implement ISBT 128 bar coding since HL7 is the data transfer method 18. Why should I have to pay to use ISBT 128. Isn't that like paying to use a bar code? 19. With the advancement of technology, won’t ISBT 128 become obsolete? 20. Where is ISBT 128 at work? 21. Is there a cross-reference database or mapping of ABC Codabar product codes to ISBT 128 Product Description Codes? 22. We are doing research in new blood components. How do I get a product code? 23. Does ISBT 128 require that a red blood cell product be antigen typed on every donation or can I label the product as antigen negative based on historical antigen testing of the donor? 24. How do you estimate the cost-benefit of ISBT 128 implementation and 25. What items should be evaluated as factors for analyzing the cost-benefit of 26. What benefits would administrators see after implementing ISBT 128? 27. Is the process overly complicated? The validation should be the same as I did for ABC Codabar since my vendor is not using all the functionality of ISBT 128. Am I missing something? 28. When will ISBT 128 be required? 29. What information is available to provide to hospital customers to help in the training effort of nursing and other personnel for the new label, unit 30. I thought ISBT was the name of the professional organization. Why is the 31. How do I label intra-operatively collected autologous blood? 32. What does ICCBBA stand for? 33. We are a network of multiple facilities under the same corporation. A) Does each facility need to register separately with ICCBBA? B) Does each facility need to have its own Facility Identification Number 34. What do they mean on the ICCBBA "Facility Annual Return" when they want to know if my facility is located in a country with a MEDIUM or LOW Human
Global ISBT 128: Frequently Asked Questions1. Does my facility need to register with ICCBBA? Registration and licensing with ICCBBA is required if you apply ISBT 128 labels. This encompasses facilities that pool, aliquot, or modify products and label them with ISBT 128 bar codes. Even if it may not be required, your facility may also wish to register and pay licensing fees in order to receive all ISBT 128 documentation and updates and access the Registered Users section of the ICCBBA Website. All new product codes, other updates and current copies of the ICCBBA databases are maintained in this section. The annual license fee for transfusion services is maintained as low as possible to encourage such facilities to maintain regular contact with ICCBBA and remain fully informed about updates and changes to the ISBT 128 standard. 2. Where will I find a step-by-step process for registration with ICCBBA? This Web site presents information about fees and the registration process, as well as a convenient registration form that you can download. After completing the registration form you may fax or mail it, together with the appropriate licensing fee, to the ICCBBA, Inc office. 3. If the name of my facility changes, will I need to re-register with ICCBBA? If the name of your facility changes, you just need to notify ICCBBA of the new name and any other changes there may be in the contact information. There is no need for you to re-register if it is only a name change. 4. If my software vendor has an ISBT 128 package available, why do I need to register with ICCBBA? A software vendor can only go as far as providing you with the capability to use the ISBT 128 standard. In order to exercise these capabilities of applying an ISBT 128 label, an initial one-time registration fee and an annual license fee must be received by ICCBBA. It is this fee that permits your facility to be licensed to use the ISBT 128 data structures. However, if your facility will only be scanning ISBT 128 bar codes (without applying new labels), your software vendor can provide you with updates to the ISBT 128 product code database without your facility having to be registered. 5. Why are there so many more ISBT 128 product codes than Codabar codes? The reason for so many more codes is that ISBT 128 codes are more specific than Codabar codes. The ISBT 128 codes differentiate between characteristics such as the nominal collection volumes, the system integrity (open vs. closed), etc. Therefore, there is not a one to one ratio between ISBT 128 and Codabar codes. 6. Where do I find the product codes that I need? ICCBBA has posted the product description codes in the registered users' section of its web site. Registered and licensed facilities can download the product description codes so long as they are current with their licensing requirements. You may also wish to discuss product code accessibility with the software vendor of your computer system. The software vendor, if registered to use ISBT 128, may already have the product description codes in a look-up table on your system. 7. How do I obtain a new product code? To request a new product description code that is not already in the database, a Request Form for Blood Product Codes may be found in the registered users' section of this website. This form must be completed and submitted to a nationally designated organization or individual and then to ICCBBA. For further information, click here. Local codes are primarily used for “boutique” or research products. They are also used for in-process products that your system may require you to track. You will have to define what that local code is and maintain records of it. Codes A0000 through D9999 are reserved for local use. 9. Is the use of the check character during keyboard entry of the Donation Identification Number required every time I type it in? The check character feature is calculated based on the ISO modulo 37,2 method. Its use is not required, but is strongly encouraged every time you have keyboard entry of your DIN. Your computer system software should be designed to recognize keyboard entry of the DIN and to require verification of the entry via the check character. This will ensure the accuracy of the keyboard data entry, eliminating any transcription and transposition errors. Although its use is optional, the printing of the check character next to the DIN is required. Other longer codes, such as the red cell phenotype, may also have keyboard entry check characters. 10. I heard there were "flags" used in the Donation Identification Number. What do you mean by flags and do I need to use the flags? Flags are part of the ISBT 128 data structure and are unique identifiers that can be used to facilitate the control of various processes in a blood center. For example, different sample tubes can be 'flagged' to ensure that the correct tube is used for a specific test procedure. The decision to use the flags is voluntary and will not interfere with shipments of blood products from one facility to another. 11. Where can I find ISBT 128 labels for validation? Sample bar codes (both valid and invalid) that can be used for validation may be found on the ICCBBA, Inc Web site. Additionally, if you are currently printing on-demand labels, it is recommended that you check with your supplier. Many of the on-demand label vendors have software packages designed to produce labels in ISBT 128 format. If you do not currently use on-demand labels, it is recommended that you contact your software vendor if you are interested in on-demand printing or contact your supplier of pre-printed labels. If they receive enough requests, they will create labels for validation. 12. My current software already supports ISBT 128 and it is validated for everything but scanning ISBT 128 bar codes. Do I need to do anything special? If you do not intend to use a bar code reader to enter units into inventory or track units at crossmatch, issue or return, then you are done. However, if you intend to use a bar code reader, a validation plan is needed to verify that the bar codes that will be read can actually be read by the equipment you have and will be correctly entered at every point you intend to use bar code reading of information. 13. Will ISBT 128 labels be readable with most bar code reading technology? If the scanner you are using is relatively modern (within the last 10 years or so) you should have no problems. "Legacy" scanners should be tested well in advance of ISBT 128 implementation. Scanners may be tested for compatibility with Code 128 by following the operator's manual for the scanner. In addition, ISBT 128 requires that every data element that is bar coded must also appear in an eye readable format. Therefore, the information will always be available even if, for some reason, the scanner cannot read the bar code. 14. Is the use of concatenation required? The use of concatenation is encouraged but not required. When set up properly, concatenation can be a powerful process control tool to prevent scanning wrong information that does not correspond to the same unit of blood. 15. We are having difficulty getting our scanner to concatenate and read ISBT 128 barcodes. What can I do? The user’s manual for your barcode scanner should have the information you need (in the form of barcodes) to turn on and off the different types of bar code symbologies and concatenation features. It is recommended that you turn off all other symbologies that are not being used. You can contact your vendor if you require additional help. 16. I am currently using the ABC Codabar bar codes and have been reasonably satisfied. Why should I change to ISBT 128? In a word: Limitations. Codabar is an obsolete bar code symbology and as time passes it will become increasingly difficult to obtain equipment that will print and scan these bar codes. Although the best solution at the time of its introduction into blood banking automation, it can no longer meet the growing demands for quality or capacity. There are other data fields on the current product label (such as red cell antigen testing, HLA phenotypes and genotypes, platelet antigen types, time of expiration) that need to be captured using an electronic system. Since there is not an on-going support mechanism for ABC Codabar, there is no mechanism to add these additional fields. In particular the error rates for Codabar bar code reads are far higher than with more modern alternatives. Code 128 (the bar code standard used by ISBT 128) has an inbuilt error detection system making it much more secure. Adoption of the modern ISBT 128 standard is justified for other important reasons. ABC Codabar capacity has been maximized and it can no longer handle the sheer quantity of all product description codes in existence. In addition, Codabar does not encode important information such as volume (450 mL vs. 500 mL) on red cell products or the anticoagulant on platelet and plasma products. Because of these limitations, Codabar product coding will no longer be able to accommodate new products, especially as Cellular Therapy product codes are added. Furthermore, the current ABC Codabar structure does not identify the donation identification number (DIN or unit number) as a unique number. In the current ABC Codabar structure, the donation DIN and the collection center must both be entered to create a unique product identification. Additionally, a number of blood centers are running out of unique DIN under the Codabar system. Their computer systems will not allow duplication of numbers which makes conversion to ISBT 128 mandatory. Since these centers may ship components outside of their regions, many facilities may receive their products. These receiving facilities will also need to be able to read ISBT 128 labels. 17. Why implement ISBT 128 bar coding since HL7 is the data transfer method used by most computers? The two systems are complementary and designed to work together. HL7 is an electronic data interchange (EDI) (communication) protocol. It does not provide a system for electronically coding information on products. ISBT 128 is recognized within HL7. The systems are therefore compatible. 18. Why should I have to pay to use ISBT 128. Isn't that like paying to use a bar code? ISBT 128 is an evolving standard which needs to continually adapt and develop to meet the rapidly changing needs of the transfusion and transplantation communities. Each year new data structures are developed and new product codes added. The license fee is used to protect your investment in ISBT 128 so that it will continue to support your needs well into the future. ICCBBA, Inc is a not-for-profit organization that uses its income from license fees to support the management and development of the standard, and to promote its global use. 19. With the advancement of technology, won’t ISBT 128 become obsolete? ISBT 128 is an information standard that is independent of the actual mechanism used to deliver it. Code 128 was originally selected as the best linear bar code symbology available to accommodate the requirements of ISBT 128 Application Specification data structures. This is still true today and there will continue to be a need for linear bar codes for the foreseeable future. In terms of future applications and extensibility, the data structures in ISBT 128 are not limited to bar coding. ISBT 128 is technology-independent and may be used in RFID and other technologies. ICCBBA Inc. continues to look ahead to new technology and applications. With the established data structures provided in ISBT 128, future conversion to new technology modes will be facilitated. 20. Where is ISBT 128 at work? ISBT 128 has been implemented in many countries. The primary advantage of the use of ISBT 128 is the commonality of the data structures so that blood products can be shipped and received between facilities without manual data entry into various computer systems. This benefit is of particular importance in the new field of cellular therapy in which progenitor cells may travel the world as Red Blood Cells of rare phenotype have been for many years. Additionally, codes are being developed to standardize the labeling of tissue products, which may also travel the world. 21. Is there a cross-reference database or mapping of ABC Codabar product codes to ISBT 128 Product Description Codes? Not at an international level, because the use of Codabar codes is not
uniform. Since ISBT 128 defines products more specifically, there
may be multiple ISBT 128 Product Description Codes for each ABC Codabar
product code. In the US, the ATAG has developed a list that will map many Codabar product codes to ISBT 128 product codes. This list is available on the ICCBBA, Inc Web site. 22. We are doing research in new blood components. How do I get a product code? ISBT 128 permits any facility to assign a 'local code' to products in development. These codes should be known only to the blood center or centers doing the research, and any facility or facilities using the new products in clinical trials, etc. Elsewhere, ISBT 128-compliant software should find such codes invalid. See the ISBT 128 Standard: Technical Specification for details. 23. Does ISBT 128 require that a red blood cell product be antigen typed on every donation or can I label the product as antigen negative based on historical antigen testing of the donor? The ISBT 128 standard does not create standards for testing—only for how the product can be labeled or how information should be transmitted electronically. We defer to AABB in the US (and EU Council in Europe) for a standard on how and when the testing should be done. We do not address whether or not you can label a unit as antigen negative based on historical results. 24. How do you estimate the cost-benefit of ISBT 128 implementation and validation? Estimating the implementation cost will largely depend on whether your facility is a blood center or a hospital. From an operational standpoint, the cost also depends on the extent of automation that is involved in your operations both today and in the future. 25. What items should be evaluated as factors for analyzing the cost-benefit of ISBT128? When analyzing implementation of ISBT 128 for your facility, some of the items which may need to be addressed are outlined as follows:
26. What benefits would administrators see after implementing ISBT 128? ISBT 128 offers immediate benefits to your organization as well as the ongoing benefits of achieving greater safety, accuracy, and efficiency in your service delivery. Core benefits include:
27. Is the process overly complicated? The validation should be the same as I did for ABC Codabar since my vendor is not using all the functionality of ISBT 128. Am I missing something? The extent of validation depends entirely on your software's ability to use the error detection and prevention built into ISBT 128 and the SOPs you have in place to use bar code reading. When the software is merely ISBT 128-compatible, validation is quite simple. By ISBT 128-compatible, we mean that the system has allowed for the larger fields used for ISBT 128 data structures, but has not incorporated validation of the input using the data identifiers. For example, in some systems the ABO/Rh, expiration date and product description codes can be entered into any field. If more sophisticated software is used, the data identifier does not allow an ABO/Rh result to be entered into a unit number field. In many countries, regulators will require documented evidence that such process controls have been validated. 28. When will ISBT 128 be required? A date for complete implementation worldwide has not been established. There is however a rapidly growing international consensus on the need to standardize on ISBT 128. Many countries in Europe and the Middle East, as well as a number facilities in the US, have already initiated or completed conversion to ISBT 128. 29. What information is available to provide to hospital customers to help in the training effort of nursing and other personnel for the new label, unit number configuration, etc? Booklets outlining ISBT 128 for blood components, tissues and HPCs [hematopoietic progenitor cells] are available on the ICCBBA, Inc. Web site. Log on the ICCBBA, Inc Web site and check out the materials available. Label examples in the available documents may be used to customize the label for a blood center or transfusion service. An implementation plan is available from the AABB on its Web site (http://www.aabb.org/Content/Members_Area/Labeling/ISBT_128/) for no charge to members. A printed version of the plan is available for $20. Hospital transfusion services will need sample labels from their blood center to use in validation and testing of their software. Bar codes to use for this purpose can also be found on the ICCBBA, Inc Web site. 30. I thought ISBT was the name of the professional organization. Why is the new standard called ISBT 128? The International Society of Blood Transfusion (ISBT) was the body responsible for initiating the development of the ISBT 128 Standard. The specification which the organization originally developed for blood labeling and data structures was based on the Code 128 bar code standard. ISBT 128 came from these origins, but today the standard is applicable to tissues and cells, and can be delivered in other formats than bar codes. 31. How do I label intra-operatively collected autologous blood? If the products will be stored in the laboratory, a local product code (first letter A-D instead of E) should be used. For example, A0001 could be be "Intra-operative Washed Red Blood Cells." Other labeling should follow national requirements. 32. What does ICCBBA stand for? ICCBBA is the name of the not-for-profit organization that continues to develop, maintain, manage, and distribute the ISBT 128 information standard. It was formally known as the International Council for Commonality in Blood Banking Automation, but over the years has evolved to encompass the tissue and cellular therapy fields as well. Now that ISBT 128 has gone well beyond just the blood banking industry, that name is unsuitable, and we have chosen to drop the name but keep the letters. So now ICCBBA is no longer an acronym, it is simply the name of our organization. 33. We are a network of multiple hospitals under the same corporation. Does each facility need to register separately with ICCBBA and have their own Facility Identification Number (FIN)? If the facility will be applying an ISBT 128 label (such as when processing or performing modifications), then they should have their own FIN. For example, if only 3 out of 5 facilities will apply an ISBT 128 label, then only 3 FINs would be needed. The other two facilities do not need to be registered as part of the group. Additional FINs can be requested at the time of registration (or anytime thereafter) for a one time fee of US$150 per additional FIN. Annual license fees will be invoiced to the corporate billing address and not each facility. 34. What does it mean on the ICCBBA "Facility Annual Return" when they want to know if my facility is located in a country with a MEDIUM or LOW Human Development Index? The United Nations ranks countries by their economic status and calls it a Human Development Index (HDI). See http://hdr.undp.org/en/statistics/. Fees are reduced for facilities that are located in countries with a Human Development Index classification of Medium or Low. For facilities in Medium HDI countries, fees are 66% of the normal cost. For facilities in Low HDI countries fees are 33% of the normal cost.
US Specific ISBT 128: Frequently Asked Questions1. I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to relabel that unit and do I have to register with ICCBBA? 2. Where does my FDA registration number and US license number need to 3. What information am I required to have barcoded on my label? 4. What labels am I required to submit to the FDA? 5. Our current system assigns a suffix to the parent unit number when aliquots are made. How will aliquots be handled with the ISBT 128 standard? 6. Am I required to specify in the ISBT 128 product code data structure (data structure 003) whether the unit is autologous, directed, or designated? 7. Must I encode the donation type in the ABO/Rh data structure (data structure 002)? 8. I see some unit labels with the expiration date and time printed on them and some of them only have the date. Which one am I required to print? 9. If I pool products that are collected from another facility, whose facility identification number is supposed to appear on the ISBT 128 label and 10. If I irradiate products that are collected from another facility, whose facility identification number is supposed to appear on the ISBT 128 label and 11. Why do I have to ask the FDA for a variance when I implement ISBT 128? 12. Is there a conversion table for ABC Codabar product codes into ISBT 128 13. How do I obtain a new product code? 14. I am a US facility in the process of completing the registration form and am not sure what to write in for question 4, Country Code? 15. Can some guidance be provided for as to how blood centers that have implemented ISBT 128 intend to address inventoried products frozen using the ABC Codabar labeling protocol or units imported from other suppliers that have not yet transitioned to ISBT 128? 16. Is there a map relating ISBT 128 product codes to the appropriate P billing codes? 17. What are possible solutions to satisfy the re-labeling requirements set forth by the FDA with respect to ISBT 128 labeling? 18. In the chance of a catastrophic event that could result in my blood center receiving an unusually larger number of blood donations,how can we prepare ourselves to accommodate for the sudden need of extra donation identification numbers (DINs) without stocking up and wasting the unused labels at the end of each year, since the collection year is incorporated into the DIN itself and there is a long turn around time for ordering more labels? US Specific ISBT 128: Frequently Asked Questions1. I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to relabel that unit and do I have to register with ICCBBA? If your facility thaws Fresh Frozen Plasma and transfuses it within 24 hours, then you are not required to relabel the unit and can just hand write the new expiration date/time. However, if your facility does not transfuse it and keeps it over the 24 hours (up to 5 days), then you will have to relabel the unit as Thawed Plasma. If you apply an ISBT 128 label (i.e., 5 day Plasma), then you would have to register with ICCBBA. Otherwise, if you are just thawing units, registration is not required. 2. Where does my FDA registration number and US license number need to appear on the ISBT 128 label? For collection facilities, the US license number can appear in either the upper left quadrant or the lower left quadrant, but not both. This information can be found in the examples section of the US Consensus Standard (section 5). The FDA registration number should appear below the collection facility name in the upper left quadrant. For modifying facilities, the FDA registration number and US license number (if applicable) should appear below the modifying facility’s name in the lower right quadrant. If both the collection facility and the modifying facility have a US license for that product, then both US licenses would appear on the label only if they have a written joint manufacturing agreement on file with the FDA. To find out whether or not you must register with FDA, please refer to FDA Registration Form 2830. Click on the link to download the form. The instructions on the second page for completing the form specify which facilities it applies to.
3. What information am I required to have barcoded on my label? At a minimum, FDA requires machine-readable labels for a unique facility identifier, lot number relating to the donor (unit number), product code, and ABO/Rh. This is specified under 21 CFR 606.121(c)(13)(iii).
4. What labels am I required to submit to the FDA? You only need to submit labels to the FDA if you are a facility with FDA licensed products. If you are in this category, then the FDA document, “ISBT 128 Labels that Need to be Submitted by Licensed Blood Establishments for Prior Approval” will give you specific guidelines as to what labels to submit. This document is available in the registered users’ section of the ICCBBA website. Again, this document only applies to FDA licensed establishments.
5. Our current system assigns a suffix to the parent unit number when aliquots are made. How will aliquots be handled with the ISBT 128 standard? Even in Codabar, the product code should have changed rather than affixing a suffix to the unit number. Although many systems append the unit number, it is technically incorrect. In ISBT 128, the product code data structure has 8 characters. The first 5 are considered the "product code", the 6th identifies the type of donation, and the 7th and 8th characters are for divisions and splits. Let's take a CPDA-1 Red Blood Cell, 450 mL collection, leukoreduced. This has a product code of E0209. It's from a volunteer donor so the sixth character is V. Undivided, the full code is E0209V00. If you split this once, the codes go to E0209VA0 and E0209VB0. The "product description code" itself doesn't change, but the division codes do. If you take the E0209VA0 and divide it into three syringes, they become E0209VAa, E0209VAb and E0209Ac. Again, the E0209 part stays the same, but division codes reflect the daughter products. So, there remains a relationship between the parent and daughter products.
6. Am I required to specify in the ISBT 128 product code data structure (data structure 003) whether the unit is autologous, directed, or designated? Autologous donations are required to be coded in the product code. Directed or designated units are not required to be coded in the product code. Although it is not mandatory to code directed, or designated units in the product code data structure (data structure 003), it may be in the facility’s best interest to do so for billing purposes. It is also required in the product code data structure is to specify the type of donation (volunteer or paid); FDA does not permit the default value of “0” (not specified) to appear on transfusable products, except for on Recovered Plasma and Source Plasma units.
7. Must I encode the donation type in the ABO/Rh data structure (data structure 002)? Your autologous units must be encoded in the donation type as part of the ABO data structure (data structure 002). If a directed unit cannot be crossed over, it should be encoded in the ABO/Rh data structure. If a directed unit may be crossed over, it should not be encoded in the ABO/Rh data structure in the U.S. 8. I see some unit labels with the expiration date and time printed on them and some of them only have the date. Which one am I required to print? In the barcode text below the barcode, the expiration date must appear in the format “31 JAN 2006”. The expiration time should not appear after the date if it is the default 23:59. It will just be understood that the unit will expire at the end of the calendar day of the specified date. In all cases, both the date and time should be encoded in the barcode itself. See example below.
9. If I pool products that are collected from another facility, whose facility identification number is supposed to appear on the ISBT 128 label and where? Pooled products should be assigned a unique identification number by the pooling facility. This number will include the facility identification number of the pooling facility and be placed at the top of the upper left quadrant of a 4”x4” label. Beneath this number should appear the name and location of the pooling facility. Records of the units used in the pool should be maintained by the pooling facility. 10. If I irradiate products that are collected from another facility, whose facility identification number is supposed to appear on the ISBT 128 label and where? The facility identification number of the collection facility should remain on the bag in the upper left hand quadrant of the label in order to maintain donation traceability. The modifying facility’s information must appear in the lower third portion of the lower right quadrant of the label if the modified unit is shipped outside their facility. Otherwise, this is optional. 11. Why do I have to ask the FDA for a variance when I implement ISBT 128? For Whole Blood and Red Blood Cells, the Code of Federal Regulations specifies that the anticoagulant must appear before the proper name of the product [21 CFR 606.121(e)(1)(ii)]. However, with ISBT 128 standards, the anticoagulant appears below the proper name. So, facilities that label Whole Blood or Red Blood Cells with ISBT 128 must request for a variance with the FDA, and the FDA has agreed to grant such requests. There is a sample letter available on the AABB website.
12. Is there a conversion table for ABC Codabar product codes into ISBT 128 product codes? A working group in the US has produced a mapping tool which is available as an Excel spreadsheet download from this site. Facilities will still need to confirm the mapping of their existing codes but the spreadsheet will make this a much simpler process. 13. How do I obtain a new product code? If the product will be potentially tracked in a computer system using ISBT 128, new product description codes may be obtained by completing the Request Form for Blood Product Codes in the registered users' section of the ICCBBA website. Guidance on submitting product code requests can be found here. A useful document to help determine the proper Class, Modifiers, and Attributes is the Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions 14. I am a US facility in the process of completing the registration form and am not sure what to write in for question 4, Country Code? The Country Code for the US is 1. For a complete list of country codes please refer to the list at www.lincmad.com/countrycodes.html. 15. Can some guidance be provided for as to how blood centers that have implemented ISBT 128 intend to address inventoried products frozen using the ABC Codabar labeling protocol or units imported from other suppliers that have not yet transitioned to ISBT 128? Most software has proven compatible with Codabar and ISBT 128. Thus, no special accommodation is needed. Facilities using software that does not accommodate both codes may re-number units using a system that allows for traceability. Many hospitals who have obtained blood from multiple blood centers have successfully used such a re-numbering protocol. The implementation plan that AABB has published on its Web site (http://www.aabb.org/Content/Members_Area/Labeling/ISBT_128/isbt128impplan.htm) addresses this issue. There is also another sample implementation plan provided on the ICCBBA website. 16. Is there a map relating ISBT 128 product codes to the appropriate P billing codes? Providing billing information is beyond the scope of ICCBBA. An excellent resource for this information is the AABB. They have a billing guide that is updated annually and a Committee on Coding and Reimbursement that addresses questions from members. The official CMS web site is also a resource. 17. What are possible solutions to satisfy the re-labeling requirements set forth by the FDA with respect to ISBT 128 labeling? A few options available to ISBT 128 users are (but not limited to): 1) Use of preprinted labels from any one of the ICCBBA licensed label vendors. 2) Use of an on-demand printer and software from a licensed vendor. 3) Several hospitals might share printing resources and use an on-demand printer to make up labels that are infrequently used. The labels could be printed in a catalog ready to be printed from as a PDF file onto adhesive paper. 4) A long term strategy is to limit the requests of the blood supplier to reduce the number of anticoagulants used, or changing hospital practice by using Adsol anticoagulated for all patients including neonates. 18.In the chance of a catastrophic event that could result in my blood center receiving an unusually larger number of blood donations, how can we prepare ourselves to accommodate for the sudden need of extra donation identification numbers (DINs) without stocking up and wasting the unused labels at the end of each year, since the collection year is incorporated into the DIN itself and there is a long turn around time for ordering more labels? The year in the DIN is only for the purpose of making the DIN unique over a 100 year period. If you reach a point in 2009 where you think you need to order more DIN sets to be prepared for emergencies, it would be reasonable to order 2010 label sets early. In an emergency, using the 2010 labels in October would be the last thing people would need to worry about. So, it is suggested that collection facilities figure out how many number sets they will need to carry them through their label supplier’s turn around time during emergency conditions. Then order your next year’s label sets at a time (and in a volume) needed to ensure readiness. Last updated: 22 January 2010 |
