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Lorig39

Make Aliquots routine

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I'm interested in finding out how other users are handling a product code change in Meditech when you divide products from a closed system to an open system which now requires a product code change. Any input would be appreciated.

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Technically speaking,

When ISBT 128 products are modified by creating an aliquot, the primary product and the aliquot prepared become A0 and B0. They don't specify which one to call A or B. Therefore, in MEDITECH, you now have to "make a component" in order to change the primary product to a modified product. If you decided to call the remainder of the primary product A0, then the first aliquot prepared would be B0. If you went back to the remaining primary product A0, the second aliquot prepared would be Aa.

Our facility has decided to make sure that the modified products can be traced back to the primary product. We will continue using the primary product as E0244V00. My "work around" to Meditech not reconizing the aliquot, is to use the 'make component" routine. Under the products that can be prepared from the primary unit (E0244) will be:

E0244A (1st aliqout)

E0244B (2nd aliqout), etc

The name of the products will be Red Blood Cells Irradiated Leukoreduced divided A or B, etc (RBC IRR LR Divided A)

We purchased preprinted product labels VA0, VB0,etc. We are not using Aa,Ab. This was also done for platelets and plasma.

We place a label on the primary bag "partial unit" so that it will not be used as a product in its entirety. By using the make aliquot routine, the user is also prevented from using the product with the status of "component" to issue. We also use a tie-tag to track the aliquots prepared. We are able to maintain the original product number (DIN), as well as issue an aliquot without a suffix being added to the product number. All of the aliquot charges now reside on the aliquot products instead of relying on the "bill aliquot" routine.

I have been actively trying to understand how it is that MEDITECH did NOT have to apply for a new 510K license for the use of their software for ISBT 128. The FDA requires so much. There is nothing to assure that the software meets FDA/ISBT 128 requirements for use. As you know, MEDITECH only considers the first five characters in a product code even though there are eight in total. So if you have a product that has the product code E0224V00 (primary unit), and E0224VA0 (1st aliquot), they would represent the same product in MEDITECH.

The other problem I see is that MEDITECH assumes that their users want to spend $10K+ to purchase a label printer to print modified product labels. I would think that most of the users do not have a donor room or produce more than 20-30 product labels per year. I could not get ANY help to validate the software without using the HEMATRAX system. At least what I have tested works.

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Are you changing product codes from a CLOSED container to an OPEN container. I found that in order to do this you must first use Make Components to create the OPEN component code then use Make Aliquotes routine to split your product in order to update the division characters. This is the advice we received from the vendor and I was just wondering what other Meditech sites are doing.

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Hello whbb: You are correct. Not everyone will want to use the Digi-Trax Hema Trax TCP/IP interface to Magic or Client Server, so we have a lower cost PC Stand-Alone Hema Trax version. In addition for very small useage we have a program to print any ISBt128 labels with only a $50.00 minimum ( see Media and Supplies on our web site www.digi-trax.com and click on "speed Print"). Hope this helps.

Richard

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We are live with ISBT 128 using Meditech Client/Server 5.4. We are using the Make Aliquot routine and are not seeing the problem you identified. the Parent Unit remains the original number. The first aliquot is "A". We have a calculated field in the npr report for our xm card that removes the "A" from the end of the number and places "AO" in a new field on the card called "Aliquot". The ISBT 128 label prints the division in the product code. Meditech recognizes all 8 characters in the product code. If the product code is scanned in, the information is found in the unit inquiry under "Other". Information can be found on the Meditech web site on the edits necessary for the crossmatch, assignment and IT cards.

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Lorig39,

I'm not sure I understand your question. In Meditech, you use "make components" to change one product (Frozen plasma) to another product (thawed plasma). When you "make aliquots", you keep the SAME product, but take volume away to create a product to issue.

I am familiar with the term "open" and "closed" systems as to whether the product bag has been entered. When the integrity of the bag has been compromised, it is considered an "open" system, and a new expiration date will be used because of it. Did you mean something else?

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Sounds like it would be easier to just get a sterile connecting device rather than deal with changing from a closed product code to an open one in Meditech. :)

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I have found that by sterile docking pediatric aliquot bags to the mother unit, the integrity and life of the mother unit is maintained. You can also sterile dock your pediatric filters directly to the unit if all your aliquot bags are used.

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Does anyone (everyone?) who receives blood from a supplier, change the facility id number to your own when you aliquot or pool and relabel?

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Winter,

If you are talking about products using ISBT 128, then you should be following their guidelines. You need to be signed up with ICCBBA in order to use ISBT 128 with modified units. Visit iccbba.org

In those guidelines, it states that if you are the facility that modifies a unit the following info should be included on the new product label:

upper left quadrant

collection facility info

lower right quadrant

further processed by (facility preparing aliquot)

The facility id number is included with the DIN (donor idenitification number). That number is supposed to follow the unit and not be changed. Only the product code(s) should be changed.

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Hello,

I manage a medium sized transfusion only hospital blood bank that aliquots and pools, but does not collect units. I have purchased unit numbers and other labels for ISBT implementation, but wonder what others are doing about outdates when they process units. It would be impossible to purchase expiration date AND time stickers for the limited processing we perform.

Thanks

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Can this be done from Meditech without the Digi-Trax printer? Our LIS person says they can, but I am having trouble seeing how to print these for expiration date and time.

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To Bankergirl: If you are printing from Hema Trax you will need a special supported Zebra printer from Digi-Trax. It is designed with firmware to work with Hema Trax software. Digi-Trax has 2 models; for higher volume the tablel top larger ZM400-BB model and now a new smaller desk top, low cost G-Series model to fit most any budget.

Richard

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BankerGirl,

It's my understanding that Meditech HAS an NPR report that can be used to create an ISBT 128 label. However, you might want to consider the path you were heading down from your initial comment.

We are about a 230+ bed hospital and decided to use overlays to create our modified product labels. The expiration date does NOT have to be barcode readable. The FDA regulation on that is the following:

21 CFR 606.121©(13)

"... the minimum contents of the machine-readable information as a unique facility identifier, lot number relating to the donor (both included in the DIN), product code, and the donor's ABO blood group and Rh type"

We also eliminated pooling products in order to continue to use the DIN provided by our blood supplier and not purchasing additional DINs. We only issue platelet pheresis and pooled cryo from our supplier. They are 5 units pooled, and we would issue (2) for orders of 6-10 random cryo.

Hope this helps.

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Is this NPR report custom build or standard. I need to have the IT label print without the A at the end of unit number and keep the original DIN numnber. Need some guidance.

 

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Are you creating a new product in your Meditech aliquot routine?  Example: RBC>RBCaliquot  or RBC>RBC (with reduced volume)?  I believe Meditech will add a letter to the DIN to differentiate between the two components when you RBC>RBC (with reduced volume).

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I  process by making an aliquot.  Mediech adds the suffix to the DIN number "A"  the ISBT product code contains the "AO" and the IT card prints with "A". It. was noted by the inspector that the Suffix added to the DIN creates a new product that does not distinguish from open vs closed and does not match DIN number.

 

 

 

 

 

 

 

 

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I would dispute that inspector's findings. What accreditation agency was this?

If your procedure indicates that crossmatch/assignment cards for aliquots will be identified with the suffix code at the end of the DIN (because really, how else can you do it within Meditech?), that should be sufficient. The rules they're talking about apply to the blood product container labeling, unless I'm misunderstanding your scenario.

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