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Bacterial Testing - Apheresis Platelets


mld123
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Just trying to find out if anyone is performing bacterial testing on their apheresis units in the Transfusion Service prior to issue.  Looks like the FDA is recommending that even apheresis units that are cultured by the blood supplier have a rapid bacterial test performed prior to issue on day 4 and day 5 of the shelf life of the unit.  Anyone following this recommendation?  If so, what test are you using?  I have used the Verax test before, but wondered if there are others available.

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FDA has this scheduled in their talks this month to move from guidance to regulation.  This is the first topic on their agenda.  But there is rumor out there that because this will raise the price for both the patient and the hospitals they may leave it at guidance until the healthcare issues are resolved.  (Trying very hard to be PC).  However, since it's a patient care issue no one really knows.  We are moving forward to bring testing in house.  All whole blood derived and apheresis platelets (including PAS) will be required to be tested once every 24 hours at a minimum on days 4 and 5.  You can also use the PGD testing to extend the outdates to 6 and 7 days (with new product codes).  Verax is the only FDA approved kit for doing PGD testing.  We will be getting in our supplies and equipment by the end of March for validation in April-ish.

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  • 2 weeks later...

Hi Marianne,

Logistically, there were a few challenges.  In our computer system (Sunquest) we defined a 6-day plt and a 7-day plt.  Verax testing is good for 24 hours, and we needed to control the outdate.  Also to prevent anyone from re-testing a 7-day and going to 8-day!  ISBT has codes for only 5-day and 7-day, so we used different ISBT codes and defined 1 set as 6-day and 1 set as 7-day.

The techs came up with a white board display, to keep track of 5-day, 6-day and 7-day inventory.  Just a simple column display with total inventory numbers.  We try to standardize the time of day we test, as the outdate is a firm 24 hours.  That way we have a minimum inventory available at all times. 

I'd be happy to share our procedures anytime.  You can email me directly at kate.murphy@bmc.org

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  • 3 weeks later...
On ‎3‎/‎4‎/‎2017 at 9:23 AM, AMcCord said:

We can't justify bringing testing in house considering the volume of platelets we transfuse, so will go with pathogen reduction when those products are available.

Same here!

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On ‎3‎/‎4‎/‎2017 at 0:23 PM, AMcCord said:

We can't justify bringing testing in house considering the volume of platelets we transfuse, so will go with pathogen reduction when those products are available.

I wish we could do this.  Our Red Cross will only bring in the necessary equipment to produce pathogen reduced platelets if a majority of hospital in the area are willing to purchase this product.  So far no takers besides us.

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  • 1 month later...
On ‎3‎/‎3‎/‎2017 at 9:36 AM, Sonya Martinez said:

FDA has this scheduled in their talks this month to move from guidance to regulation.  This is the first topic on their agenda.  But there is rumor out there that because this will raise the price for both the patient and the hospitals they may leave it at guidance until the healthcare issues are resolved.  (Trying very hard to be PC).  However, since it's a patient care issue no one really knows.  We are moving forward to bring testing in house.  All whole blood derived and apheresis platelets (including PAS) will be required to be tested once every 24 hours at a minimum on days 4 and 5.  You can also use the PGD testing to extend the outdates to 6 and 7 days (with new product codes).  Verax is the only FDA approved kit for doing PGD testing.  We will be getting in our supplies and equipment by the end of March for validation in April-ish.

All whole blood derived and apheresis platelets (including PAS) will be required to be tested once every 24 hours at a minimum on days 4 and 5. 

I thought my blood supplier told me that verax test could not be done on the PAS platelets.  You may want to check the verax package insert for interfering substances and approved products for testing.

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https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM425952.pdf

This is in Draft status, but should be finalized this year.  Once finalized, FDA will give 2 years for implementation.  Transfusion services should not be mandated to make changes until some time in 2019 or later.  There are some misstatements in some previous posts that should be clarified.

  • PAS apheresis platelets can be stored up to 5 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4 or 5.  The use of platelet additive solution does not confer any protection against bacterial proliferation.
  • Plasma-stored apheresis platelets can be stored up to 7 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4, 5, 6, or 7.
  • Pathogen reduced apheresis platelets can be stored up to 5 days and can be transfused up until expiration without additional testing.

 

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