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New barcoding ruling by FDA


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I was wondering if anyone else is in the same situation that I am in:

Our hospital collects only autologous donations for surgeries here- so we do no testing and don't ever send the units out of our facility.

Does this new barcoding thing mean that we have to get barcodes for our unit numbers and our facility- even though no one will ever read them since nursing isn't required to be able to scan the barcodes?????

:roll:

Please Help!!!

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  • 4 weeks later...

My institution collects autologous units as well as makes modified components (syringes, pooled products,etc) and the FDA clarified the rule of bar coding for hospitals in that all products will need to be bar coded.

It does make sense to bar code all products so when point of care bar coding of medications, specimen collection and transfusions are implemented, the nurses will be less likely to circumvent the system of using the bar codine scanning devices. As usual, the Blood Banking community will be the first to get this piece in place before the rest of the system.

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We are also currently planning the implemenatation of barcodes for all blood and blood products. We also issue pedi syringes and hematopoietic stem cells.

Which hardware system are you looking at? Is your LIS engaged in the selection?

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I am looking at Digitrax thermal laser printers for the label makers. We has MISYS as our LIS and there is an agreement between the two vendors so hardware is not the issue for us.

Our issue is in deciding on a system for the nurses to use on the floors (Carefusion, Lattice, or Bridge-Medical). These are the only three vendors who have med administration, specimen, and transfusion administration all in one software package.

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Mario, are you aware that MiSys was NOT planning on interfacing with the Digitrax ISBT label printing software? I submitted it as an enhancement request and it was discussed during the May 25th Blood Bank SIG call. It was rated a 1 (critical risk). MiSys has a discussion with DigiTrax planned this coming week. You may want to contact your MiSys support person to voice your opinion and get the latest information.

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  • 1 year later...

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.

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  • 1 year later...

Is there anyone out there on version 23.1? Do you use Change or Divide? If using the divide process, have you been FDA inspected? Was it acceptable to barcode the mother unit donor number and product and accept the actual dropdown -A, -B, etc?

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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

Are we talking about cerner classic or mellinium???:confused:

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Cerner Millennium does support Digi-Trax ISBT 128 label printers as a standalone printers. The ME 2007 rev supports Interfaced printers. Currently we are in the middle of upgrading from ME 2004.08 to Cerner ME 2007.08 and planning on Interfacing our Blood Bank module with the Digitrax ISBT128 printers. We are a multisite facility and have 6 Blood banks on the system.

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