5 day plasma again and again and again.

[John C. Staley]

I keep running into road blocks. The most current being, who can received thawed plasma with the extended out date and who can not. For those of you who extend the out date of thawed plasma upto 5 days, are there any patients you have identified that you would not transfuse with plasma that was thawed more than 24 hours prior to the transfusion? If so who and why?

Thanks

John

[Eagle Eye]

We do not give thawed plasma(5day) to our ped patient. We get ped pak from supplier. In my computer system once we modify ped pak it has only 24 hrs expiration. All our thawed plasma can not be divided in the LIS(one tech found a way around and did it once but since then we educated our staff and we do not divide our thawed plasma)

All others get same product. Thawed plasma was approved by transfusion comm.

We keep 8 units (O, A & Bs) thawed all the time and keep rotating. Most of the time all the patient get thawed plasma which has atleast 2 days left on it.

[bmarotto]

We do not have pedi or neonatal patients. We give our plasma three day dating and that has all but eliminated any outdating. We have a very active hepatobiliary/liver transplant service. We approached this group first and they agreed to the extended dating without hesitation. We then went to the Medical Practice Committee for hospital wide approval and was able to say both the Transfusion Committee and liver team recommended extending the dating. Our liver team is very well respected and with their support, we had no difficulty getting approval.

I did have a reference I used. I will look around for it and post it.

[John C. Staley]

Thanks for the replys. The "current" concern is pediatric patients. Neonates we would not give anything that had been thawed more than 24 hours, no supporting data just wouldn't do it. Now the concern has moved to peds patients and whether or not to avoid giving anything to them that has been thawed for more than 24 hours. It will be interesting seeing how the corporation currently defines a pediatric patient.

[bpkelly]

We were just cited by AABB and CAP for not using a 2 step process for labeling our plasma. We use Plasma Frozen within 24 hours and take it directly to a 5 day out date. We use a very aggressive prospective review system and do not issue theis plasma for anyone with a factor VIII deficiency. Has anyone been cited for immediately labeling this plasma with a 5 day exp? If so - did you challenge it or change your process? Now of the literature is particularly supportive of either position.:mad:

[bmarotto]

We take our Plasma Frozen within 24 hours, thaw it, and immediately give a 3 day outdate. We have not had a problem but we do label it as "Thawed Plasma" at the time of thawing. All our patients receive this same product whether it be 1, 2 or 3 days post-thaw.

[Eagle Eye]

Kelly,

It is very important how you label them. DO you call it thawed plasma or not? We do not use plasma frozen in 24 hrs but we use regular FFP but call it thawed plasma from the time we thaw it. We label our thawed plasma by crossing out the word fresh frozen and writing thawed

WHat was the citation? DId they cite you guys for labeling or not calling thawed FFP for first 24 hr and thawed plasma after that????

[MJDrew]

We take FFP directly to thawed plasma and label it like this from the get go. We have only neonatal ICU; no other pedi patients, but would use regular FFP thawed at time of order for these.

Right after we instituted the protocol several years back, we had both an FDA and CAP inspection within a few months of one another, neither of which had any issues with the process we use. We thought we would make more mistakes trying to initially label it thawed FFP and then having to switch the label to thawed plasma by missing the 2nd relabel at 24 hours. FDA mentioned that we were labeling by "least common denominator", ie, we were not claiming the product was anything more than thawed plasma. A product labeled thawed plasma MAY exceed standards for thawed plasma if it is within the initial 24 hours after thawing. This is not a problem; it is the product labeled thawed FFP that is more than 24 hours old that is a "misbranding" problem with them.

[bmarotto]

I agree totally. We open ourselves up to errors if we have to stop and relabel at 24 hours. We have very active liver transplant and cardiac surgey programs. Plasma is thawed throughout the day so the 24 hour relabeling would be an hourly process. "Least common deominator" labeling is the way to go for us.

[bbbirder]

For all of you who have gone to 5 day plasma, do you convert FFP that is from apheresis collections or just 'regular' FFP? It seems I have heard/read you cannot convert the aphersis FFP.

I would like to go to 5 days, but am hesitant to do so unless I can convert all thawed FFP to 5 days. We have quite a mix of regular FFP and apheresis FFP. It would be plenty confusing for generalist techs.

Thanks,

Linda Frederick

[Eagle Eye]

We do not convert FFP pheresis to 5 days because they are consider open system.

Which computer system do you use? WHen I validated 5 day plasma in our LIS, I seperated FFP pheresis and FFP. If you log in FFP pheresis computer automatically gives you 24 hrs expiration and for FFP you get 5 day expiration(I have it set at 120 hrs). I added all product code related to pheresis under FFP pheresis and all 18201 goes under FFP. ALL our tech must use barcode reader to log in the products. We have been using 5 day plasma for more then two years. I performed several audits and didn't find any problem. Couple of time tech logged in ped FFP under FFP but tech thawing ped FFP notified me and I corrected them in the LIS(before issue).

[bbbirder]

The computer system can take care of some of this for us. Still, when you have generalists working in BB, and they have a hectic time on midnight shift, I think having different expirations for products is somewhat of a burden, not worth the gain. Our FFP use is sporadic and low, I am not sure we would prevent outdate by keeping product for 5 days anyway.

Thanks for the input,

Linda Frederick

[ABQ bloodbanker]

I have been researching 5 day plasma because we outdate so many with the 24 hour rule. I plan on relabeling units as thawed plasma with a 5 day outdate from the get-go for use on all patients except neonates, pediatrics and liver transplant patients.

[Franklyn]

The difference between fresh thawed plasma and 5 day plasma is the presence (or absence) of the labile factors. When you thaw the product it has those factors and should be labeled as "Thawed Fresh Plasma" - 24 hours later those factors are gone and the product becomes "Thawed Plasma". To thaw and immediately label as "Thawed Plasma" would be mislabeling the product (IMHO) and as a CAP and AABB assessor I would also issue a deficiency or citation (depending on the regulatory body) for such a practice.

The reason for labeling 24 hours plasma differently is related to this thought process.

We do not distinguish (therapeutically) between the products EXCEPT for babies. Our medical directors and the baby-docs have agreed to the thawed fresh plasma variety for exclusive use on infants.

[ABQ bloodbanker]

Franklyn,

Would you consider it mislabeling if the original product was 24hr plasma and not "FFP"? That is typically what we get here.

[JMunden]

It is my understanding that apheresis product can be labeled as thawed plasma if it is a "closed" system. Your supplier should be able to help with this. We do not give thawed plasma to neonatal nor severe DIC patients. Our computer "outdates thawed FFP". I relabel as Thawed Plasma after editing expiration and making the component product. We currently use Thawed Plasma codabar labels placed over the previous FFP label. I foresee ISBT changing our current process.

[Franklyn]

We stock both Fresh and 24 hour plasma and treat them as interchangable products. The definitive answer to this question really needs to come from the FDA (not CAP, AABB and most certainly not me). I do not know of anyone that has actually pitched the question to the FDA, but they are quite particular about labeling and I feel is it better to error on the cautious side. We, too, relabel once the "Thawed Fresh" product has expired and extend the expiration date/time.

[bbbirder]

I don't think that the FDA would consider immediatelyl abeling a product as "thawed plasma" to be a mislabeling. Your are labeling it as a 'lesser product' so your labeling claims are not incorrect and you are not claiming it has something it doesn't.

Just like putting a shorter expiration date on a product, while it might not be correct, does not violate the FDA regulations. While 'misbranding' with a longer expiration date is clearly a problem.

Linda Frederick

[Mary]

Does this apply to both FFP and Plasma Thawed Frozen within 24 hrs?

[Sandy Smietana]

This is the criteria we've established for the product

Criteria for thawed plasma transfusion includes:

è -PT and PTT >1.5 x the mean normal value in a non-bleeding patient scheduled for surgery or invasive procedure;

è -Diffuse microvascular bleeding, transfusion of >1 blood volume, and PT and PTT >1.5 x the mean normal value or not yet available; and

è -warfarin overdose with major bleeding or impending surgery.

Other indications may include:

è emergency reversal of warfarin,

è treatment of plasma anticoagulant deficiencies such as protein C, protein S, or antithrombin III when specific therapy is not available

Advisable exceptions include

è Inpatients with Factor VIII deficiencies,

è Severe DIC,

è Thrombocytopenia Purpura

è Hemolytic Uremic Syndrome.

Hope this helps

Sandy Smietana

Genesis Clinical Lab

MacNeal Hospital

[John C. Staley]

My understanding is the same as Linda's. It appears that the FDA considers labeling to the "lowest common denominator" to be an acceptable practice.

The problem may come if your facility has limitations on what product can be used when. If you say you can only use FFP for neonates then you can't provide them with a product labeled as thawed plasma but if FFP, 24 hour plasma and thawed plasma can be used interchangably then labeling every thing as thawed plasma after thawing should be acceptable because all three meet the requirements for thawed plasma.

[caj1018]

We have been using FFP and FP interchangable for several years. The computer gives the product an expiration date of 5 days as soon as we change the product status as thawed. The product is labeled with the 5 day expiration date and time with a purchased sticker. If the product(s) are not transfused that day and are kept refrigerated, the following morning the day shift techs will put a yellow "plasma" sticker over the fresh frozen or frozen words on the product label. This is our fix until ISBT 128 labels are ready.

We use AB FFP pedipaks for neonates and always within 24 hours. We have a busy NICU, but rarely have pediatric patients. Any patient treated in our peds would be handled the same as a NICU patient. We would rethink this if we had a busy peds department.

[Franklyn]

I can accept the logic of labeling as a "lesser" product. That makes sense but I, personally, would still be a bit cautious in pursuing that practice.

As I understand it, the reimbursement for Fresh thawed plasma is different than that of 5 day plasma. So you would loose a bit on reimbursement revenue by such a practice.

[MJDrew]

There may be some difference in reimbursement, but for inpatients receiving plasma units, this makes absolutely no difference in what the hospital is reimbursed, as this is determined by DRGs (diagnostic related groups) and one lump sum is recieved by the treating facility based on patient diagnosis code, not "divvied up" among the various departments. It might make a small difference if patient was receiving plasma as an outpatient, such as outpatient plasma exchange.

One would have to balance the amount lost by "least common denominator" labeling versus the gain in decreasing outdates and wastage.

:DMJD

[bbbirder]

For reimbursement, CMS codes reflect the 'parent' product, not the final product.

You can link to the latest CMS stuff here, but this is a huge file and you'd want to search for the product.

http://www.cms.hhs.gov/HospitalOutpatientPPS/downloads/cms1392fc.pdf

This shows just a couple of them:

P9017 is for Plasma Fzn w/in 8 hr 2007 rate is $70.21

P9059 is for Plasma Fzn w/in 8-24 hours 2007 rate is $76.77

Linda F