Gkloc

The OR staff collect the specimens.

The Cerus Intercept system for pathogen reduction does this.

Yes you are correct, if you use pathogen reduction you would no longer need to irradiate platelets.

I found the FDA Guidance for this which I have attached. There are a couple of ways that the FDA is saying will meet this Guidance. So if you don't keep platelets on hand you may not need to do anything if your supplier does the initial bacteria testing, but if you receive a platelet on day 4 or 5 of life you would have to check with your supplier to see if they would be performing that secondary bacteria testing on the platelets for those short date units. Bacterial_Risk_Control_Strategies_for_Blood_Collection_Establishments_and_Transfusion_Services_to_Enhance_the_Safety_and_Availability_of_Platelets_for_Transfusion_Dr.pdf

Yes there is a Guidance from the FDA regarding bacteria testing of platelets that has been a Guidance for awhile. One of the methods to be compliant in this is to use pathogen reduced platelets, or perform bacteria testing on platelets on day 4 and 5 prior to issue. I was told that the FDA is being told that they need to finalize this Guidance this year around October, I believe.

We use the STAT Spin Express 4 here which allows us to centrifuge our specimens for 3 minutes.

I installed the new software update for the Vision and it crashed the analyzers database. I was told this was a rare occurrence but I haven't tried to perform the update again. I have not seen any problems with mold growth in the diluent on the analyzer. We change ours every 24 hours.

It's not a regulation yet. It is just a recommendation right now. The key word though is yet.

We send out our pregnant patients for D molecular testing if they have a specimen sent out to a reference lab that ID's them as Rh Negative and then when they come here for their RhIG injection we test them as Rh Positive in Gel. So far everyone of them we have sent has come back as not being candidates for RhIG.

If you are using the ALBAQ controls we use sample 4 and spin it down and remove the supernatant (or most of it) and add 4 or 5 drops of anti-D to it then re-centrifuge. This will give you a positive result for controls. I am currently in the process of validating the Vision and performing correlations, but this is what we use for QC on the ProVue.

Genesis BPS also make a couple of different tube sealers. I currently have a benchtop and a portable model

Does anyone who attended this webinar remember the name of it? I would like to check this out and I am hoping that it is/will be posted on the ARC Success site. Thanks

I agree with Teristella, and thankfully I have no stories like this to share. Here is an AABB standard that you can use: 4.3 Incoming Receipt, Inspection, and Testing Incoming blood, blood components, tissue, derivatives, and critical materials shall be received, inspected and tested, as necessary, before acceptance or use.

If you visit the ASCP website it let's you know what the requirements are for taking the SBB without going through an SBB school. The last time I checked on it you only needed 5 years of Blood Bank experience, but it could have changed.

We are not looking into this because I believe in order to extend the shelf life of platelets to 7 days you have to be a registered/licensed facility with the FDA. We transfer our short date platelets to our Trauma hospital who has a better chance of being able to use them before they expire.