Richard Kriozere

Hi Linda: We would be happy to clear all this up for you. If you give me your contact information we can send a complete set of ISBT128 sample labels and information on labels, software and hardware. Hema Trax has the facility to print ISBT128 Donor Identification Numbers (DIN) aka Unit Numbers in any format you wish, single ply or piggyback, in strips or multi-bar code sets. You can contact me at rkriozere@digi-trax.com or by phone at 800-356-6126 X-106

Many Classic users have purchased the Digi-Trax stand-alone PC Hema-Trax on-demand ISBT128 labeling system. Although Cerner offers our system as an interface for Millennium we can only offer stand-alone for Classic. This can be upgraded at lower cost to our TCP/IP service for Cerner or any other Blood Bank computer system in the future. Information can be seen at www.digi-trax.com

Linda: I suggest you contact either the ATAG chair SUe Grabowski ( sgrabows@giveblood.org or Pat Distler the Tech. Dir of ICCBBA ( pat.distler@iccbba.org). Digi-Trax's Hema Trax that is interfaced with Magic and Client Server from Mediech does have the ability to print DINs and Facility, but no one has asked just to print facility and we do not have a label that size. We have a 2 X 3.2434 to print Facility and Product and a 4 X 4 full Face Label...by the way there is no ISBT128 Facility bar code. So not quite sure we understand problem. You can call our head of software development if you wish, Larry Cullen at 847-610-7454.

I think you are on right track to develop an ISBT128 implementation plan. Further you might like to know that Meditech in Magic and Client Server both have integrated Hema Trax from Digi-Trax ( www.digi-trax.com ) to provide all ISBT128 required labels on-demand form a specialized Zebra thermal transfer printer (model Z4M-BB) If you are budgeting we can supply all information.

All blood establishments that manufacture, process. repack, or relabel blood or blood components intended for transfusion and regulated under the Federal Food, Drug and Cosmetic Act or Public Health Service Act are required to use "machine-readable" codes. Currently both Codabar and ISBt128 are FDA acceptable. The regulation for products subject to the rule include all components intended for transfusion; see 21 CFR 606.121©(13) You can ask at regulatory@aabb.org, www.iccbba.com, or www.fda.gov/cber/faq/barcodefaq.htm. Who is your software vendor and do they provide the facility to print ISBT128? If you receive blood or blood products from American Red Cross or others they will be switching to ISBT128 so you will certainly need to read/scan ISBT128 bar codes. PS according to AABB the applicability of the bar code rule to hospital transfusion services is not determined by their FDA registration status. Non registered are impacted if they pool Platlets or Cryoprecipitated AHF for ease of transfusion or aliquot blood components. They don't need to FDA register but must comply with rule.

If you are an AABB member you ought to contact AABB and get the ISBT128Implementation Guide that they publish...$20.00 and it may be available if I recall to non-members.

Any bar code scanner that autodiscriminates will read Code 128 and since ISBT128 is Code 128 with special data identifier prefixes to ID ISBT128 rather then some other bar code, they will scan. Your software on your computer or hand held PDA needs to look for those special data identifiers in order to determine if you have ISBT128 or not. I suggest that you register with the ICCBBA at www.ICCBBA.org and get your 5 digit site registration code and then you can see the US Consensus Standard with all ISBT128 data. Labels for ISBT128 can be purchased in small quantites for smaller hospital needs or printed on-demand from all US Blood Bank computer systems. There are also systems that can print on-demand from a stand-alone PC.

Sorry: The proper web site is www.iccbba.com

Are any hospital transfusion services out there planning to implement bar coded transfusion verification? And, if so do they plan to utilize ISBT128 and a 510(k) approved product at bedside in conjunction with the new ISBT128 compatibility label/tag format approved recently by the ICCBBA? ( see: "What's New"; bulletin #8 at www.iccba.com )

Digi-Trax has Windows label design software that will drive most every popular thermal printer. You can design and save label designs and print from blank labels. The software from NiceWare International ( www.nicewareintl.com ) will also take data from most any data base. See www.digi-trax.com or contact info@digi-trax.com. Free demo versions are available.

Digi-Tra and Cerner have reached an agreement to interface our on-demand ISBT128 labeling system...we hope to talk with them more about expanding an ISBT128 standard Compatibility label/tag and patient ID to facilitate bed-side transfusion verification Richard

I am certain that the donor's original Unit Number must always remain visible.

Speaking for Digi-Trax...we have consumated our Misys agreement and they are currently interfacing our Heam Trax on-demand ISBT128 compliance labeling system into their next release. We have done same with almost every other systems company in US. Digi-Trax also has a stand-alone PC system. Check www.digi-trax.com or call 800-356-6126. There is also a bed-side transusion verification system from Korchek Technologies, which Digi-Trax is marketing ( www.korchek.com ). If you only have a few items that require bar codes for ISBT128 compliance Digi-Trax can provide small quantites via our Quick Print program.

If you have interest in printing all required ISBT128 labels in your facility Digi-Trax Corporation has both a stand-alone PC system and an interfaced system...Hema Trax.LPS. We have Hema Trax interfaced or in process of interfacing to almost every computerized blood bank management system in the US. For details look at www.digi-trax.com or contact: 800-356-6126, info@digi-trax.com.; Fax 847-465-9055( 650 Heathrow Drive; Lincolnshire,IL 60069 )

I suggest you run your question by Ken Zemann at CBER. His email is zemann@cber.fda.gov or call 301-827-6145. I suspect there is no geography available.

Checked with expert...when you modify and you print with Hema Trax in the lower right quadrant your reg. # and Lic. No. in eye read format only. That is below the CMV testing data and Bar Code. There is no ISBT128 bar code required for the " Further Processing By" portion of the label. Richard

There is an ISBT128 bar coded label/tag standard on the horizon for crossmatching and transfusion verification. Check out the members site at www.iccbba.com and look at "what's new " Other data can be added to these standard forms.

Our company ha sISBT128 on-demand labeling systems in Kuwait and Saudia Arabia and you may wish to contact me at 847-613-2106 or a rkriozere@digi-trax.com. See our web site: www.digi-trax.com

If you are interested in printing yourself on-demand we can send you some label samples to test. Call me at 847-613-2106 or email: rkriozere@digi-trax.com. Richard Kriozere

See the ISBT128 web site www.iccbba.com and log into member site and see "what's new" Bulletin #8. We now have a standard ISBT128 label/tag bar code format to be used with standard patient ID band for electronic transfusion matching. Our company will shortly be producing this label/tag and adding a module to our Hema Trax on-demand printing software. If you want to get a sample or are interested call me at 847-613-2106. Richard Kriozere

It has always been difficult to label refrigerated or frozen product. In order to get any label to adhere you must train folks to observe special proceedures: WIpe off frost, ice and water ( moisture). Most pressure sensittive adhesives will not stick to moisture. The label must be placed on top with hand pressure and warmth from the palm. Also a good idea to keep the labels in a warm ( about room temp. place ) area. We do now have some new adhesives that we have used with some blood centers successfully for 13/4 X 3 inch labels on fresh frozen plasma bags. We can provide samples for testing.

Sorry I caused confusion, but there is some conflicting information. I would check the International Council on Commanality in Blood Banking Automation ( ICCBBA ) web site: www.iccbba.com and look at"About ISBT" and Frequenlly Asked Questions #7. It does seem to indicate that April of 2006 the CFR requires "machine readable" labels. The AABB will require for accreditation in the 25th Addition of their Standards; that:cries: ISBT128 be used by Nov. 2008. You can also ask the question of the ICCBBA via their web site and get a definitive answer. Also the Red Cross now has published an implementation plan. When I return to my office on April 12th I will try to post some documents from FDA, CBER that might also shed some light on the subject.

Actually in April 2006 you only need plan to implement ISBT128 bar codes for all products. May 2008 all products brought to patients must be bar coded. You should talk with your LIS and/or Blood Baqnk software vendor. Almost all have interfaced with our ( Digi-Trax's Hema Trax.LPS ) on-demand ISBT128 compliance labeling software. We also have a stand-alone PC prodcut available for those that do not have LIS with this facility. You can get more information by visiting our web site: www.digi-trax.com and look at Blood Bank Software ( Hema Trax }

I am aware that electronic PDT or other computer systems thet do transfusion verification now require a 510(K). I believe thta some companies have a 510(k) and that some have submitted. Can we have the names of those that have a 510(k) and those that have submitted? We have worked with some interesting ID band designs with bar code and/or RFID that might work well in conjunction with such bedside systems.

Are Hospital Transfusion Services aware that the American Red Cross has sent information out about their ISBT128 Implementation to all regions? They plan to begin implementation next summer in the North East region. Have any hospitals received this information and what are their plans?