Eagle Eye Posted March 19, 2006 Share Posted March 19, 2006 New barcode requirement(FDA) is effcitive April 26,2006. As per AABB Association Bulletin #06-03...." all blood and blood components including autologous units collected within a hospital and to all aliquots, syringes and pools..... We do not collect at our facility but we have ped aliquot and pooled products. I am wondering how others are dealing with this requirement. We use pooled cryo label which has product code with barcode label which goes on pool product but other information is not barcoded. Our syringe do not have any barcoded information. Please give me your input...Thank you in advance. Link to comment Share on other sites More sharing options...
donellda Posted March 20, 2006 Share Posted March 20, 2006 Our quality specialist is working with the LIS department on this issue. We do get a barcode label with the pool number for platelets and cryo, and aliquot number for aliquots but not for component codes. Those poor quality guys have the weight of the world on their shoulders. Link to comment Share on other sites More sharing options...
Richard Kriozere Posted March 23, 2006 Share Posted March 23, 2006 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 } Link to comment Share on other sites More sharing options...
Mary Posted March 23, 2006 Share Posted March 23, 2006 Does anyone know where we can purchase pooled product barcoded labels?Also, can we address why we have to have these if our hospital does not have a bedside computer system for blood transfusions? Link to comment Share on other sites More sharing options...
Mary Posted March 23, 2006 Share Posted March 23, 2006 Richard,What is your source you the May 2008 date? Link to comment Share on other sites More sharing options...
Cliff Posted March 23, 2006 Share Posted March 23, 2006 Hi Richard, Could you please clarify your position for us? Here is the FDA Federal Register link - http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm. Here is a brief excerpt: "SUMMARY: The Food and Drug Administration (FDA) is issuing a new rule to require certain human drug and biological product labels to have bar codes." "DATES: Effective Date: This rule is effective on April 26, 2004. Compliance Dates: Drug products that receive approval on or after the rule's effective date must comply with the bar code requirement within 60 days after the drug's approval date. Drug products that received approval before the final rule's effective date must comply with the bar code requirement within 2 years after the final rule's effective date." AABB's Association Bulletin 06-03 talks about the requirement for ISBT, I don't believe FDA will require ISBT 128. Association Bulletin 06-03 footnote excerpt: "As a separate matter, upcoming editions of AABB Standards will set forth requirements relating to ISBT 128 implementation. The 24th edition of Standards for Blood Banks and Transfusion Services (effective Nov. 1, 2006) will require that facilities have a written plan for the implementation of ISBT 128, and the 25th edition (effective May 1, 2008) will require implementation of ISBT 128 by accredited facilities. The 2nd edition of Standards for Cellular Therapy Product Services (effective March 1, 2007) will require that facilities have a written plan for the implementation of ISBT 128, and the 3rd edition of those standards (effective Sept. 1, 2008) will require implementation of ISBT 128. (For additional information regarding ISBT 128, see Association Bulletin #05-12.)" So, the way I read these is all products that leave the blood bank as of April 26, 2006 must have some type of bar code. It doesn't matter if you facility uses this information anywhere else. By November 1, 2006 we must have a plan to implement ISBT 128 in place. As of May 1, 2008 we must have implemented ISBT128. The dates are different for cellular therapies, please see above. 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 } Link to comment Share on other sites More sharing options...
bmarotto Posted March 25, 2006 Share Posted March 25, 2006 Does this rule apply to Factor concentrates if they are reconstituted in the blood bank and issued in a syringe? If so, we will have to discontinue reconstituting and issue the product in the original packaging. Link to comment Share on other sites More sharing options...
Cliff Posted March 25, 2006 Share Posted March 25, 2006 I've attached the AABB Association Bulletin 06-03 and the Federal Register document for your reading enjoyment. Does this rule apply to Factor concentrates if they are reconstituted in the blood bank and issued in a syringe? If so, we will have to discontinue reconstituting and issue the product in the original packaging.04-4249.pdf1368.pdf Link to comment Share on other sites More sharing options...
bmarotto Posted March 26, 2006 Share Posted March 26, 2006 Thanks Cliff. Those documents cured my insomnia! Seriously, I had read them before. It is the part the refers factor concentrates to labeling requirements under 21CFR 610.67 and 201.25 that has me confused. I don't see anything specific to reconstituted product either way. I think the safest thing is to issue the dose required in the original packaging and have the reconstitution done at the bedside. Our techs will be thrilled, but the nurses....... Link to comment Share on other sites More sharing options...
Richard Kriozere Posted March 30, 2006 Share Posted March 30, 2006 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. Link to comment Share on other sites More sharing options...
bnawrot Posted March 30, 2006 Share Posted March 30, 2006 We are currently trying to meet the machine readable label requirement with a DYMO label printer. The user will have to manually enter the unit# into a stand-alone program that will allow us to print on-demand unit number barcode labels. We already have ABO/RH, facility id, product code barcode labels that we purchase. We are really close. Cliff, thank you for including the Federal Register link here. I was unaware that the FDA established an "effective" date for the barcode labeling requirement 21 CFR 606.121.©(13)(iii) already on April 26, 2004. I'm assuming the deadline of April 26, 2006 that AABB established for the machine readable label requirement in Association Bulletin #06-03 and the proposed 24th edition of Standards is the 2 year compliance date set by the FDA. The Assocation Bulletin is a little confusing since they state the effective date of the rule for blood and blood components is April 26, 2006. What would have been better was to use compliance or implemenation date since the FDA "effective" date was April 26, 2004. Please correct me if i'm wrong. Link to comment Share on other sites More sharing options...
jamuffley Posted April 5, 2006 Share Posted April 5, 2006 We are currently trying to meet the machine readable label requirement with a DYMO label printer. The user will have to manually enter the unit# into a stand-alone program that will allow us to print on-demand unit number barcode labels. We already have ABO/RH, facility id, product code barcode labels that we purchase. We are really close. Cliff, thank you for including the Federal Register link here. I was unaware that the FDA established an "effective" date for the barcode labeling requirement 21 CFR 606.121.©(13)(iii) already on April 26, 2004. I'm assuming the deadline of April 26, 2006 that AABB established for the machine readable label requirement in Association Bulletin #06-03 and the proposed 24th edition of Standards is the 2 year compliance date set by the FDA. The Assocation Bulletin is a little confusing since they state the effective date of the rule for blood and blood components is April 26, 2006. What would have been better was to use compliance or implemenation date since the FDA "effective" date was April 26, 2004. Please correct me if i'm wrong. After reading your post, we were wondering if you dispense aliquots in syringes? If so, what barcodable product label are you using? We are considering using a "divide" label, but can't seem to locate a label for "CPDA1, irradiated, leukoreduced, divide" Link to comment Share on other sites More sharing options...
Mary Posted April 6, 2006 Share Posted April 6, 2006 Does anyone have an electronic copy of the AABB Weekly Report from 3/31 that you can send me? Link to comment Share on other sites More sharing options...
Eagle Eye Posted April 7, 2006 Author Share Posted April 7, 2006 Mary, Send me your e-mail address, I can send you electronic copy of weekly report 3/31/06. Link to comment Share on other sites More sharing options...
Eagle Eye Posted June 9, 2006 Author Share Posted June 9, 2006 Try Design Pro 5 limited (Avery.com)to make barcoded pool product label. Link to comment Share on other sites More sharing options...
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