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Cliff

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Posts posted by Cliff

    3 hours ago, BloodBanker80 said:

    You can scan the units you want to set up as emergency release to print a label that you apply to the product requisitions (which at least saves you time/errors from writing that portion).  You have the emergency release form with the set (of lets say 4 units) with the numbers filled in. 

    Correct

    3 hours ago, BloodBanker80 said:

    When they call, you grab the pack out, write the name/MRN on the Emergency release form, all 4 product requisitions including label that gets applied to the actual unit.  The person who picks up the product signs the form, you make a copy?  and they take it for physician signature as well and returns the form with the cooler (making an assumption).

    We print an ADT label and place that on the requisitions, no handwriting.  We hand write on the emergency release form.  That is a two part form.  We keep a copy and send the original to the requesting clinician.  They sign and return - or we have a resident hunt them down to get signed and returned.

    On 5/3/2018 at 2:26 PM, BloodBanker80 said:

    Brining back this topic haha, Cliff - We are in the middle of revising our process and I have a couple of questions.  I'm hoping to get some ideas we can use to better our process.  Your emergency release products:  Are they pre-tagged - with downtime handwritten forms that have the unit information or with computer generated forms with a fake trauma name/MRN?  Which LIS do you use? 

    We use HCLL.  We have multiple sets of products in the fridge.  We attach a blood product requisition to each.  We can't pre-print the product info from HCLL onto the tag, but we can pre-print a 4x4 label with all of the product info and place that on the tag.  When they call us, we require the patient name / MRN, even if it's a fake name / MRN, then we print a patient label and add that to the requisition also.  Our Emergency release form is pre-filled out with the nit numbers, and we keep a bag of the segments from the units with each set, also pre-filled.  That way we do as little as possible when handing out the cooler.  We're a level 1 trauma center and get a fair number of trauma's or bleeders.

    10 hours ago, Patty said:

    If I validate the MAXQ cooler for 12 hours am I required to take/record a temp every 4 hours since it is considered Blood Storage? I doubt the cooler would ever be used for more than 4 hours but I suppose I should have something in place in case.

    How much validation would you suggest since it comes with a validation report?

    FDA and AABB had gone back and forth over the years on storage vs transport.  In the past few "Ask the FDA" sessions I've been at during the AABB Annual meetings both FDA and AABB have said coolers are transport.  People even brought up newer cooler technology reminding them that coolers can be out of the blood bank for an extended time.

    We validate our coolers to hold temp at 1 - 6.  We do not take temps every 4 hours.

    Posted

    What are your issuing policies regarding issuing products with regards to product / specimen outdate?

    Let's say the specimen is going to expire at midnight, the red cell is still good for a couple of weeks, will you issue the product at 11:45pm knowing they will not infuse it before the outdate of the specimen?

    Let's say you have a specimen that is good for a couple more days.  The patient requires a washed platelet.  It only has a four hour outdate from the time you start washing it.  It's going to outdate in 10 minutes, do you still issue it?

    Now think of this with the mindset of issuing hundreds of products a day, so you can't work closely with the nurse who requested the thawed cryo to ensure they infuse it before the 6 hour limit.

    5 hours ago, Eagle Eye said:

    can some one post a link or form for all users here?

    there are two forms right? correct me if i am wrong...BPDR and adverse event?

    Thanks

    It's very easy (and preferred by FDA) to do it online.

    https://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm?CFID=40907533&CFTOKEN=d53320b604cd5b33-CA2F5DED-DE8D-E592-8495BFDE2A8C4673

    The form can be found here:

    https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/default.htm

    We have LN2 here, we used to have a lot when we processed bone marrows.

    LN2 won't consume oxygen, it will displace it with nitrogen, which already makes up most of the air we breath.  If it's going to be stored in a tiny room, you may want an O2 sensor.  Our storage unit and supply tank are in our lab.  We've never had an issue.

    The supply tank is usually pretty big and needs to be replaced regularly.

    Who will be responsible for the tissue?  That's what worries me the most.  :)

    12 minutes ago, sherif said:

    thanks but my question not about their benefits my question if i want to do the three procedures for RBCs unit will i start with filtering it then irradiate it finally wash it or what  ?

    I suspect it does not matter.

    For the filtering, you need to follow the manufacturers instructions from the timeline for filtering.  Most require the product to be filtered early in its life.

    If it were me, and this is based on preference, not any rules, I would:

    1. Filter
    2. Irradiate
    3. Wash

    Filtering is likely required early in the products life, irradiating releases potassium, washing will help remove some of that potassium.

    14 hours ago, sherif said:

    but in second question if a doctor need this RBCs unit in the same day and i want to do the three procedures : filterate it then irradiate then wash or what ? and why ?

    Filtering is to remove white blood cells.  They are not useful in transfusion and often cause transfusion reactions.  Irradiating "inactivates" the white cells by destroying the DNA within the cells and preventing them from engrafting in the recipient.  Washing removes plasma proteins, these can also cause transfusion reactions.

    14 hours ago, sherif said:

    And in the third question if this procedure done in open system the 2 bag (CSP and CRYO ) are affected with their preparation( i mean their expire date )  or not ?

    http://www.aabb.org/resources/marketplace/Documents/Primer.pdf

    14 hours ago, sherif said:

    And in first question whole blood respin can cause RBCs hemolysis or not ?

    I'm not sure, possibly, but unlikely.

    2 hours ago, sherif said:

    In second question i mean foe example if a doctor want washed -filtered- irradiated RBCs unit what is the correct order for the three procedures?first then second then third and why ?

    Most leukoreductions systems have times limits.  You want to get as many of the WBCs out as soon as possible to prevent them from breaking down and releasing cytokines.  I would see what your manufacturer requires for leukoreduction.

    Once it is washed, it is an open system and only has a 24 hour expiration.  You could wash / irradiate in either order.  Irradiating will release potassium from the cells, but even if you irradiate after washing, the release during that 24 hour period will be minimal.

    2 hours ago, sherif said:

    In third question if we have FFP unit without satellite bag  can we connect satellite bag  to FFP units to prepare cryo ( open system ) and freezing will affect on any bacterial contamination or we must do this in closed system ?

    Can you sterilely dock on the bag instead?

    23 hours ago, John C. Staley said:

    Ann, on the flip side I bet there is a lot that gets reported that doesn't need to be reported for fear of getting caught not reporting something.  Unless the FDA has improved their information in the past few years, a lot of what they say leaves a great deal of room for interpretation.  :confuse:

    @John C. Staley, this may be true, but the FDA does actually review each file.  They notify us a couple fo times a year that an event is not reportable.  

    2 hours ago, hmlange said:

    Good Morning,

    I have never heard of mixed ABO pools but the Technical Manual does not state that pooled units should have the same ABO. For facilities that use/manufacture pooled cryo, how often do pools have mixed ABO types? Any reason not to mix ABO types in a pool?

    Thanks!

    We get ours pre-pooled from ARC.  Far too much QC needed to do it in house.  Also, I your LIS may not play well with a mixed ABO.

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