Hi all,

JCAHO posted the following letter dated July 1, 2011...

http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQId=353&ProgramId=4

I'm concerned by the statement "For extension of the FDA requirement to infuse plasma within six hours of thawing to 24 hours, a variance must be requested from the Food and Drug Administration. A sample variance request form can be found at www.aabb.org/resources/governmentregulatory/bloodcomponents/Pages/resources.aspx. This is a common request and is not related to FDA licensing or registration. The Joint Commission will recognize the FDA variance as evidence for extending the expiration date in compliance with FDA requirements."

I was raised from a baby med tech thinking (and verifying through AABB) that Thawed FFP had an expiration date of 24 hours, not 6 hours. What are your thoughts on this? Did your transfusion service file a variance to extend the expiration date to 24 hours?

Thanks in advance!

The current, FDA approved circular of information states ffp/thawed should be infused within 24 hrs, if stored between 1-6C. I have been involved in multiple FDA licensed operations - have always used 24 hr outdate on plasma - have never had this discussion with an FDA field rep/CSO.

A couple of years ago, an FDA inspector told me I had to apply for this variance. So I did and it was granted (of course) in Dec 09. I don't know what the FDA's current rule on this is. You might want to contact them directly. It sounds like maybe this has changed. This came about because many years ago, (showing my age) the outdate for FFP was generally considered to be 6 hours. The FDA just never caught up with the rest of the world.

Thanks for your responses!

Just a point of information...

After calling it "The Joint Commission for the Accreditation of Healthcare Organizations " for years, or fondly and phonetically, "JAYCO," they went and changed their name!

Now it would appear that they want us to call them "TJC," for they have become, simply "The Joint Commission." Don't know why. Perhaps it is because the original title wouldn't fit on their building (which is not far from where I live)?

It is required to get a variance. We just finished our TJC inspection two weeks ago and the inspector asked about and wanted to see our copy of variance. I had heard about this from my local blood center (Puget Sound) last year and we used the sample request form verbatim. We sent it in to the FDA and recieved our variance within 6 weeks.

I recommend getting the variance, it's easy and the most painless dealing I've ever had with any form of the federal government. And It saved my bacon in the inspection.

It's simple and painless to get, doesn't even take very long, so I'd go for the variance.

I think the variance is a good idea, too. Since I could only find references from April 2010 that still states 6 hours, I emailed the FDA and this is what I heard...

Hi,

Have the regulations (Title 21, Volume 7) been updated since April 2010? I’m particularly wondering about section 606.122.

Thanks,

Becky

Dear Ms. Snedeker,

Thank you for your inquiry. The Center for Biologics Evaluation and Research (CBER) is one of seven centers within the Food and Drug Administration (FDA). CBER is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, human cells, tissues, and cellular and tissue-based products (HCT/Ps), gene therapy and xenotransplantation products.

There were no changes to 21 CFR Part 600 for 2011.

I hope this is helpful.

Sincerely,

Lonnie

We had a variance also. As was stated, it is not difficult to obtain. Since then we have gone to 5 day plasma, which FDA does not regulate.

We had a variance also. As was stated, it is not difficult to obtain. Since then we have gone to 5 day plasma, which FDA does not regulate.

Hi I have worked in the Texas Medical Center and we put a 5 day expiration date on our thawed plasma. Actully all places in Texas that I had worked at had 5 day plasma. I currently live in California where they put a 24 hour expiration date on plasma. My question is what would we need to do in order establish the 5 day plasma in our blood bank?

Thank you

Thank you everyone for the useful information. I'm sending for a variance using the template today!

Hi I have worked in the Texas Medical Center and we put a 5 day expiration date on our thawed plasma. Actully all places in Texas that I had worked at had 5 day plasma. I currently live in California where they put a 24 hour expiration date on plasma. My question is what would we need to do in order establish the 5 day plasma in our blood bank?

Thank you

We did some homework to show that the 5 day plasma had about the same level of factor content as plasma frozen within 24 hours and thawed. We focussed on the emergency room physicians, as they were the most resistant for some reason. In the end, we told them that they had to go with it if they wanted to have a massive transfusion protocol. Having pre-thawed plasma is the only way to begin to keep up with a massive transfusion protocol. (we send 6 units of plasma with each cooler). Everyone seems happy with having plasma available quickly. We have had no complaints about lack of response to plasma infusion. We have been using it for about 4 years now.

We have been using 5 day plasma for just under a year and the physicians didn't seem to be very concerned as long as they got the same response from the products. The part of the project that took the longest was getting the computer system and the labels setup for new products. Our plasma has gone way down since we implemented.

The simplest way to convert to 5 day plasma is to discuss it with your medical director, put it in your policy, and start doing it.

The important thing is to label it correctly. If you are issuing a unit that has been thawed for greater than 24 hours, then it needs to be relabeled as "thawed plasma." If you label the unit properly, then they are being informed of what is in the bag.

Some places go from the frozen state directly to 5-day "thawed plasma". Others go through a conversion step.

We thaw it first with a 24 hour outdate. If the units aren't used within 24 hours, we relabel them as thawed plasma with a 5 day date. The units go to the first "FFP" order that comes up and is ABO compatible. We are using ISBT labels. We have pre-printed labels. We apply the correct ISBT-coded component label (which depends on the original FFP product code) and hand write the new expiration date on the unit.

For the original question about the 6 hour expiration for FFP per FDA, that is correct. FDA will provide you a waver to use a 24 hour expiration. Most transfusion services do not have this since they are not used to seeing FDA inspectors.