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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.

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.

I was searching the web for info of ISBT 128, and it came up in the search. I clicked on and liked what I saw.

Our facility has been using Meditech since 1997, and we have never had to edit a cord blood type. I believe the usefulness of having the cord blood type in history outweighs the remote possibility that it is incorrect. There is a reason why this blood type is reported as the "cord blood" type. We would not use the cord blood results for transfusion purposes. Although our cord bloods are labeled with the mother's information, Meditech has a built-in connection to the infant's information. The two admit infos are available on both the infant and mother's account. Prior to having this connection, we added queries for the nurses to answer so we would have the mother's info at the time the order is being created. The cord blood type is a "temporary" blood type for an infant. If we were unable to determine the Rh of an infant due to a positive DAT, we would call them Rh negative until we could prove it otherwise. We would add a comment to their history. I tried something that may help Meditech users. If you DID NOT want to report to history the blood type from a cord blood, consider the following: 1) Remove the blood type interpretation from the cord blood type test. You could either create a new T-type test and enter the blood type (make it reportable), or do not result the type at all in results. The blood type would not go to history. However, your users will not be able to see the cord blood type either (Rhogam candidates, etc) unless you make it a reportable result. 2) You can have a cord blood type if you go the the "Change Blood Type" routine and enter the infant's blood type as "UNKNOWN", and give the infant a temporary blood type the same as the cord blood type. This would allow users to see the temporary blood type in PCI. 3) When you order and result a regular blood type for this patient, the "temporary" blood type will now be reported and replace the "UNKNOWN" blood type. If you try to enter a blood type other than the temporary blood type, the user will receive a warning, and will not be able to result the blood type from the result screen. I'm not thinking of doing this, but it was interesting to see if I could come up with a solution.

Remember that the AABB is the only agency (at this time) requiring the use of ISBT 128. The FDA requirement is as follows: "21 CFR 606.121©(13) states the following information on labels must be machine readable as well as eye-readable after 4/26/2006. Includes aliquoting,pooling, or relabeling *Unique facility ID *BUI (Donor Idenification Number or DIN) *Product Code *ABO/Rh Does not include expiration dates Does not differentiate between Codabar and ISBT 128" We are a small hospital and we do not print any unit labels. Traceability is the most important aspect of unit labelling. Although I found an AABB requirement that stated, if a facility receives a unit with a Codabar label, they MAY elect to use a Codabar OR ISBT 128 label for the DIN, I could not find a statement that said that the FDA required the use of an ISBT 128 DIN if the product was received with an ISBT 128 DIN. You might want to speak with your blood supplier. We made an arrangement with them that if we requested a product (PC,FP,Platelet pheresis) that we knew was going to be divided for a neonate, they have a label printer available and they send extra barcode readable DIN labels with the product. Also keep in mind that this applies IF the modified product remains at your facility and is not transferred somewhere else. Remember that when using ISBT 128, the DIN stays the same, and the product code changes. We had our label supplier (Shamrock, www.shamrocklabels.com), create product codes for our aliqouts of PC, FP, and Platelet pheresis that we place on our base label for our aliquot. Shamrock will create any exisiting ISBT 128 label. They are not considered a custom label even if you are the only one requesting it. We also purchased the blood type barcode labels. We kept our cost down by selecting only one product code for each of the three possible prouct types to aliquot. That is because we can trace any aliquot to the parent product. PC:E0224VA0-E0224VH0 FP:E2701VA0-E2701VD0 (only asked for 4 divisions) PLT:E3046VA0-E3046VD0 (only asked for 4 divisions) We also had our computer guru create three labels we place on top of our base label when we make an aliquot: *Blood Supplier(s) Source information including FDA reg/license *Our Facility Source information including FDA reg for "furthur processed by" *Exp. date:______________

We call all cold reacting antibodies "COLD" because we are not typing the antibody (I,i,H,etc). Also, these types of reactions can be transient. We only worry about these if they react at 37 and/or AHG and we perform a prewarmed antibody screen (AHG) and prewarmed xm (AHG). If they do not react, we call it compatible, and we are done. For extremely strong colds, you may have to use warmed washed cells.

Our hospital is AABB. In the last two previous surveys, it was ALWAYS a nursing error that gave the BB an infraction. Why is the BB so heavily inspected and nursing is not held accountable?

We are using Meditech Magic 5.61v. I implemented the ISBT 128 for our market (3 hospitals). Next year, we will be going to eTAR. I'm not seeing the nurses wanting more on their plate. We currently collect all transfusion slips and enter them by hand. We do not use the "presumed transfused" routine. Please keep me in mind as we can be mutual resources.

If you are accredited by the AABB, then you must have implemented ISBT 128 label format by May 1,2008 to be compliant. Currently, only the AABB is requiring that the labels be in ISBT 128 format. This would include labels for modified products.

MEDITECH only recognizes the first five characters of the product code as the product code. You will need to use the E/E Other fields to further define the type of donation and divisions. Each pheresed product in ISBT 128 will be given a separate product code. If you facility has not applied for registration with ICCBBA, you will need to do that first in order to legally scan ISBT 128 products. You can go to their website:www.iccbba.org. There is also a ton of information and the standards for use on this website. When you create your ISBT 128 products, it is important to have only one barcode defined for each product. This is neccessary if you plan on using the HEMATRAX printer to print your product labels. HEMATRAX will only recognize the first barcode listed in the product dictionary. I created all new products when defining ISBT 128 products. I did not use the old PC,FP products because there were many products that were defined with this product. Your blood supplier should be able to give you a list of products that you will need to be able to receive using ISBT 128 and sample barcodes.

I just saw your post, sorry it wasn't sooner. ICCBBA at their website, has a listing called "Special Testing General" that was last updated 03/01/08. It lists all the acceptable codes for Special Testing that can be used in ISBT 128. The code you are referencing N0008 is interpretated as "CMV seronegative". The code (1aaaa) for "CMV antibody negative" is no longer in use.

I have listened to a recorded class dealing with eTAR. It was directed to nurses who would now be responsible for recording transfusions in MEDITECH. My first reaction was, no way I'm letting nursing be responsible for entering the transfusion information. This is one of the features of eTAR. Another is scanning the barcodes at the bedside in a similar fashion to pharmacy and eMAR. I'm just glad I'm not going to be the first one to try this....

Reliegos, This is probably the "most" correct way of creating modified units. Every facility has different needs. Pat Distler from ICCBBA states the the most important thing is traceability of the product(s). At our facility, we are not creating a barcode label from a printer (HEMATRAX) for modified products. We purchase the overlay product code label (A0,B0,C0,etc) and blood type labels to keep the cost down. Remember, the more complicated the process is for Techs to follow (part timers), the more likely it is that it won't be done correctly. I suggested to someone else who was using the scheme your facility is, to make the overlay for the modified products ahead of time and keep them with the parent unit. If you don't apply the DIN, you can keep using this overlay until you actualy create a product and add the DIN. This way, the next division that is supposed to be used will be known. If you are creating an entirely new label for the product (HEMATRAX printer), then this is not neccessary.

At our facility, we combine the red cells and plasma together prior to issue. We use MEDITECH software, and elected to issue to the floor the reconstituted product. We use the component routine to create reconstituted blood. We manually transfuse the FFP stating the volume transfused plus that it was given as part of the reconstituted blood. For our product label for ISBT, we were able to work with Shamrock labels to select the appropriate ISBT code to use which they made for us. Shamrock has stated that if there is an ISBT label that we want, as long as we provice the ICCBBA number for it, they will create it for us at the standard label price (not considered custom). Here is what our label says: E5747V00 RECONSTITUTED RED BLOOD CELLS IRRADIATED LEUKOCYTES REDUCED PLASMA ADDED Approx___mL Red Blood Cells From 500 mL CPDA-1 Whole Blood and ___mL___ ___Plasma Store at 1 to 6 C You write the volume of red cells used AND the volume and Blood Type of the FFP used.

Our facility is using MEDITECH. There is a problem in that Meditech only recognizes the first 5 characters of a product code. The product code would look like this: E0224V00 (parent) E0224VA0 (aliquot) In MEDITECH, the system would see this as the same product and therefore could not coexist in inventory. When using the make aliquot routine, the product name stays the same, and the unit number changes by adding a suffix to the end (W1234081234A). With ISBT, the unit number is to stay the same. Meditech created a program that would exclude the suffix from the issue form, but it is still there in the unit number. This will be a problem when we have to scan barcodes at the bedside because the unit numbers won't match. My "work around" is to use the make component routine instead. In the component routine, the unit number stays the same, and the product changes. For example, frozen plasma to thawed plasma. In my dictionary setup, I did this to identify separate products to issue as an aliquot (or in this case, the components that can be prepared from this parent product): PCILR.E0224 (parent product name) PCILR.E0224A (1st aliquot name) PCILR.E0224B (2nd aliquot name), etc Each aliquot product (PCILR.E0244A) has the primary unit number remaining the same as the parent product. The aliquots are labeled with the division product codes (E0224A0). At the time of issue, only the unit number is scanned (not the product code). The user can select the appropriate product from the list that appears. I use the parent product code as E0224V00 and never change that. One advantage to using the make component routine is that the user is not allowed to issue the primary product once it has the status of component. Our facility does not allow units that are no longer a complete unit to be issued as a whole unit, so this helps eliminate that problem also. We do not receive divided units from our blood supplier, so we don't have the problem of scanning divided products that would be perceived as being the same product.

David, We created these rules because there is an AABB survey question that asks what steps the facility has in place to assure that a patient that reaches the age of four months will be treated like an adult sample. I don't think saying that the Tech will cancel the order and place the appropriate order will suffice. I actually created three rules: 1)Pediatric Packed Cells when pt reaches 4 months of age (RULE1) 2)Pediatric ABO/Rh when pt reaches 4 months of age (RULE2) 3)Pediatric TS when pt reaches 4 months of age (RULE3) RULE 1 ;If patient's age is greater than 4 months, then PCPEDI can not be ordered. ;A patient whose age is greater than 4 months will be required to have a Type and Screen performed every 72 hours. "PT GREATER THAN 4M OF AGE, ORDER PC"^MESG, [f pt cur age]^AGE IF{AGE#2="M" AGE$3^MT}, IF{AGE?0N!(AGE#1="Y")!(MT>"03M") MESG}^X, IF{X [f lord err msg](X); [f lord ok]}^OK, IF{OK [f lord ok]; [f lord reject]}; RULE 2 ;If patient's age is greater than 4 months, then test can not be ordered. ; "PT GREATER THAN 4M OF AGE, ORDER ABO/RH"^MESG, ***the rest of the rule is the same as RULE 1*** RULE 3 ;If patient's age is greater than 4 months, then test can not be ordered. ; "PT GREATER THEN 4M OF AGE, ORDER TS"^MESG, ***the rest of the rule is the same as RULE 1***

Mabel, Check with your blood supplier. Pheresed Plasma has separate product codes in ISBT 128. Check these codes out for example: E4689 1st container E4694 2nd E4697 3rd E4701 4th, etc. They should be conforming to the ISBT 128 standards for naming products.

Angie, I'm figuring you don't require help with Codabar seeing how this is a string called Meditech ISBT. There has never been an actual product called "Autologous Packed Cells". We probably all created one however. Meditech allows the user to identify the autologous product by 1) blood type, and 2) reserved status of the product. You can also further identify the unit by the information entered in the "other" field at the bottom of the enter units routine. If you want to have a separate "product" so you can continue to identify those products as autologous, here is how we handled it in our market. Our facility uses a "marker" to identify the product as autologous. We had our I/T card NPR program changed to include a total of three markers at the time of issue. The other facility wanted to continue to call the product autologous. We realized that ONLY autologous products will be received w/o being leukoreduced. Therefore, to the existing Codabar autologous packed cell, we added the ISBT 128 product code. When they receive this product, it will continue to call it an autologous packed cell. Apheresed products all come with a separate ISBT 128 product code. Although it's a pain to go from about 10 products to 100+, they all need a separate barcode. We changed the name of the products: apheresis leukoreduced platelet 1st container mnemonic:PLTLRA1 2nd container mnemonic:PLTLRA2 If you are NOT planning on printing barcode labels for your products, you could continue to use the products from Codabar and add all of the products under the ISBT 128 symbology. EVERY ISBT 128 PRODUCT NEEDS A SEPARATE BARCODE IF YOU PRINT PRODUCT LABELS BECAUSE HEMATRAX WILL ONLY RECOGNIZE THE FIRST ENTRY FOR THE ISBT 128 BARCODE. However, all pheresed products will need to be a separate product in the Product Dictionary regardless because the DIN stays the same in ISBT 128. No suffixes allowed. Hope this helps.

anti, We are not going to be purchasing a separate label printer. We will be using preprinted labels. See my reply to another string called "make aliquot routine". Let me know your concerns. I'm also using "Magic", and I can't use the make aliquote routine as written for the "Magic" users.

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?

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.