FDA reportable 1st and 2nd containers

[Antrita]

I found what I consider the perfect storm of an error since it had 5 people involved. I think there is 1 FDA reportable part but if any one thinks there is more than 1 please reply.

1. An evening tech missed several units when bar coding them into the computer. Two of the units involved had the same ISBT-128 number but were 1st and 2nd containers.

2. Three days later a CLS was typing units, found the 1st container was not in the system, typed it but did not look to see if any other units from that same batch were also not in the system.

3. Two days later a CLS set up the 2nd container for a patient and it was transfused. The unit tag that went out with the issue was for the 1st container.

4. 3 days after this another CLS working with the actual 1st unit was unable to issue it as it supposedly been transfused to the first patient. Instead of investigating what happened he decided it was a computer error and released the issue from the first patient and issued it to his patient. Didn't bother to leave me any kind of message.

5. The floor where the first patient was transfused did not return the Issue/Transfuse form until yesterday which is when the error was caught. This was 30 days after the transfusion so now I can not even bill the patient for the unit.

I think the FDA reportable is giving the 2nd container to a patient labeled as the first container. I am not sure what the code is. If any one knows I would greatly appreciate the information. I don't think any of the rest of the mess is reportable.

Thanks

Antrita

[DPruden]

LA-82-** Crossmatch tag or tie tag incorrect or missing information {Use LA-82 if tag physically attached to the unit is incorrect or missing information, or both the tag and transfusion record are incorrect or missing information; Use LA-83 if transfusion record, accompanied with unit, is incorrect or missing information}

LA-82-04 Product type or code incorrect or missing

I would use LA-82-04 if the tag was physically attached to the unit, but it could be LA-83-04 (depends on how your transfusion record is attached. See the link below for further explanation.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129721.htm#bllbl

[Antrita]

Thank you, I thought someone asked about this once before but I couldn't find.

Antrita

[Bill]

The fact that unit 2 was not retyped in your lab is also reportable IF your policy does not state that split units only need to be typed once.

[Antrita]

This was the one area that is a little fuzzy with everyone. Our computer system will not allow a unit to be crossmatched that has not been retyped. Sometimes the retype labels will fall off and the unit gets typed twice. It is possible that he looked the unit up and thinking it had fallen off and put the information on a new label. He says he did not do this. Do you think I need to write up the possibilty the unit wasn't typed?

[Bill]

Since your system will not let crossmatch without retype, are there retype results entered in the computer? If so, your'e OK, otherwise that aspect should also be reported--in my humble opinion, if you cannot prove that it was retyped, report that aspect as well. The last thing you want is for an inspector come in and find that without you having reported it first.

[Antrita]

You are right, I can't prove that the unit was typed so I will include this with my labeling error. I know when I retyype a unit and I find it was already typed (retype label missing) I put a not in comments on the unit. I see the weakness in my system, I need a second req ordered on a unit that is typed twice to tract this issue. I don't know if this would have caught the error but it would have a least made them think about what they were doing.

[DeeMc]

I have been tossing this around for awhile. If the Blood Bank computer system will not allow crossmatch of a unit where the retype results have not been entered, is it necessary to continue to add a reytpe label to the product? I would love to hear everyone's opinion.

[Beverly Morris]

If the only way to identify the unit as retyped during computer downtime is a physically-affixed label, then you need to continue to label them. If there is a downtime workaround, this step could be omitted.

[PaulSunV]

There are several ways to approach this depending on the size of your facility.

A small facility (25-30 units) that doesn’t crossmatch many units could do the retype as part of the crossmatch process and then only label them as being retyped. This becomes somewhat of an issue depending on the computer software you have as this will sometimes leave those units on the pending work log.

A medium sized facility that doesn’t have much room could put labels on the units as they come in indicating that they haven’t been retyped and that label could then be removed when the unit has been retyped.

A larger facility that has the room can designate a shelf in a refrigerator for all units that haven’t been retyped, no label required as they are on a shelf that has that designation, and when they have been retyped the units would be removed from that shelf and placed in with the available inventory.

[VACASE]

We used to put a sticker on units that were ABO/Rh confirmed but stopped doing that a few years ago. We have a shelf in our refrigerator where un-confirmed units are stored until the confirmation is done.

[L106]

My thoughts when I read the initial post: What a mess!!!

We balance our inventory as part of our daily morning chores. That is, we physically count the donor units and make sure the count matches what our computer tells us we have in our inventory. Therefore, the first error in this scenario would have been detected the next morning, not three days later. (Much easier to investigate what the problem was when it just happened the previous evening.)

Our computer also will not allow you to crossmatch a red cell donor unit if the ABO(/Rh) recheck has not been done, so we dropped the "Recheck" stickers on the units a couple years ago. (No problem.)