Hi,

1. What kind of form is sent with the blood unit how is it attached to the blood unit? or is it?
   
2. What is the crossmatch label like and is it tagged or adhered?
   
3. Where do the transfusionist and witness sign?
   

We have everything on the attached tag in 3 copies even the signatures are there and this must change.

Thanks,

Liz

Adhered labels are not allowed any more - apart from the ones used by the blood centres that are permenently fixed (and ahve been validated). Something due to the risk of generic glues leaching through the bag into the blood. We use a double part label that attaches to the bag with a cable tie. The top part has stickers attached to it that go into the patients' notes and the bottom is a tear-tear off that is returned to the lab for traceability. It's a zebra printer that is used and it's really reliable

Adhered labels are not allowed any more - apart from the ones used by the blood centres that are permenently fixed (and ahve been validated). Something due to the risk of generic glues leaching through the bag into the blood. We use a double part label that attaches to the bag with a cable tie. The top part has stickers attached to it that go into the patients' notes and the bottom is a tear-tear off that is returned to the lab for traceability. It's a zebra printer that is used and it's really reliable

What kind of adhered label are you talking about? Do you know of a regulation or standard regarding this? My TJC and AABB inspectors have never commented on the ID labels we usre on the back of the bag.

So the pink printed crossmatch autoadhesive label with 2 parts is no longer used??

Yes a reference would be great.

What regulatory agency says these labels are no longer allowed?

Sorry in the UK... I'd just assumed with the regs being so much tighter there that the US would have caught onto it too. Just trying to take a picture of our labels

oh a picture would be great! Thank you!

A Note: we are CAP and TJC accredited.

In the U.S., only FDA approved adhesive is allowed for labels that attach directly to a blood product, so I understand that if you are going to attach to the unit directly you must be sure to use an approved adhesive (like what the blood bag manufacturers use). At our facility we use a 2 part pre-printed Transfusion Record (i.e. top copy carbons through to the back copy when you write on it. Our Blood Bank computer system prints 3 Compatibility adhesive labels with patient/unit information. One of the labels is placed on a tie-tag which is attached to the unit with cable ties. The other 2 adhesive labels are attached to the 2 copies of the transfusion record which are designed to accompany the unit. When we upgraded computer systems we went to this system of printing 3 labels in order to get away from a transfusion record that was printed on a dot matrix printer. In our old system we also used a 2-part pre-printed form, but we had to use a dot-matrix printer to get the information to carbon through when the system printed it. The old from had a peel off sticky label which we also adhered to a tie tag. The up-side of our new system is getting away from dot matrix printers and going to a Zebra-style label printer. It prints the 3 labels quicker than our old system would print a transfusion record. The down-side is that now we have to manually attach the label 3 times, once to the tie tag and then to each of the 2 copies of the transfusion record so product compatibility labeling is a slower process; before we just had to peel of one adhesive label fro the tie tag.

Sandy - I thought there might have been some sort of regulations there too!

Having issues with emailing a picture from my phone but I will as soon as I get home.

Sandy

Do you have an easy reference from the internet for this sticker thing?

We have a two part (front and back copy), full page form attached to each unit. Its large but the form has space for all transfusion info (temps, BP, etc) as well as a documentation area for how the transfusion went. The form also has notes on how to detect a possible (eg febrile) or likely (eg hemolytic) reaction.

The top form has a smaller removable sticker that has all of the unit crossmatch documentation on it. When we issue a unit, we peel off this sticker (duplicate info remains on the front and back copies) and stick it on the back of the unit. That way, if the tag is separated form the unit (common during the transfusion), all of the unit and patient ID info is still on the unit.

If the stickum is an issue, we have not heard about it. We had the FDA here last year and they said nothing about the stickers (they were very thorough!)

Thanks, Scott

Is the full page form size A4?

Is the full page form size A4?

Ya. 9 by 11 1/2 or whatever.

We were inspected by FDA last fall and this was not brought up. The tag and label all print out together. We attached the tag with a TACHIT gun and stick the label on around the segment tail so it sticks to itself. 3 weeks ago we went live with the EMR so now we only put the label on the unit. Everything else is documented in the EMR so we would only use the whole tag during computer downtime. Satellite facilities put the tag on if the patient is being transferred to us (main facility) (for use in the ambulance or helicopter) and that would then be scanned into the EMR.

As Auntie-D has said it became unacceptable in the UK some years ago to stick extra labels on the blood bag because of the risk of the glue leaching into the blood through the bag. We could order labels with acceptable glue, but most opt to use a label tag that can be attached to the blood product bag. Platelet bags if I remember correctly are designed to allow a bit of breathing through the bag and extra labels inhibit this process.

Steve

:)

Many US blood bank label companies use acceptable adhesives I believe--like Shamrock and the blood band companies.

At my prior workplace we changed to a transfusion record that is a chart form created by nursing. There wasn't much point in making the lab print the nursing chart record when we no longer wanted to get back a copy. We really wanted nursing to take ownership of that document and getting it completed accurately. The unit was issued with a tie tag attached and the chart record was created once the unit got to the floor by putting a sticker from the bag on a sheet with the patient label on it. They used the same sheet for several units (separate columns for each unit). This approach becomes even more sensible once you get a transfusion module in the nursing computer where all of the transfusion data is recorded. Not issuing the blood with a separate form also makes it impossible to issue the unit with the wrong paperwork.

Many US blood bank label companies use acceptable adhesives I believe--like Shamrock and the blood band companies.

At my prior workplace we changed to a transfusion record that is a chart form created by nursing. There wasn't much point in making the lab print the nursing chart record when we no longer wanted to get back a copy. We really wanted nursing to take ownership of that document and getting it completed accurately. The unit was issued with a tie tag attached and the chart record was created once the unit got to the floor by putting a sticker from the bag on a sheet with the patient label on it. They used the same sheet for several units (separate columns for each unit). This approach becomes even more sensible once you get a transfusion module in the nursing computer where all of the transfusion data is recorded. Not issuing the blood with a separate form also makes it impossible to issue the unit with the wrong paperwork.

I like this concept. Nurses' form is a regular Chart record sheet and I assume your labels have the pt and unit id. Can you remove the label in case the unit is returned?

Do you not want to check any part of the trasnfusion record after the transfusion or do you run audits?

Mabel, I see that your label is not adhered to the bag but rather to the tag, ok.

Can you tell me more about the sticker in "putting a sticker from the bag". Is it a barcoded sticker or is there written info and how was it generated initially.

Thanks

We use a crossmatch label on the bag (we purchased one that had FDA approved adhesive), and also use a 2 part form attached to the bag with a fastener. We have an EMR but are still on paper for transfusion administration because the system is not FDA approved for that. I would LOVE to get rid of the 2 part dot matrix form, but for now we're stuck with it.

I have attached "sticky" compatibility labels to units with no problems from any inspectors (AABB/CAP/FDA). These were ordinary labels, no FDA required glue - they are not part of the permanent labeling so they are not a regulated label. Currently, I only attach a compatibility label - transfusion documentation is on line. The label is attached with a twist tie.

We also use labels for the bag, paper copy for the chart. Transfusion tag has a peel off label that goes on he unit. Same glue is used that is used by the donor centers to attach labels. At least that is the glue I specified when I first ordered them.

Our last Joint Commission inspector asked me if our crossmatch labels were on FDA approved label stock, and I said "yes, ma'am". Not sure if she could have cited me for it if I said no... From what I understand from the FDA, if the label is primary (touching the actual bag) it has to be an approved adhesive. If overlaying the label over the primary label from the blood center, it is OK if it is not...although it's hard to find a blank spot large enough for this to work.

We use heavy cardstock to print our tag from a regular laser printer and fold in half. Then we use the garment gun to attach to the unit. The facility is then required to fax back the vitals on the one original tag and we put a copy in the patient file.