barobinson

Wondering how all of you plan on implementing the new bacterial detection testing standard by AABB? We plan on using Verax since it will be the only test method that can possibly work in our institution. We wanted to pre-pool the platelets after testing using a sterile connecting device and then have the expiration date be the date of the unit that outdates first in the pool. We had been told by Verax that some places using their testing performed testing once every 24 hours, so we thought we could do the same with the pre-pooled products. As of today we still have no name of a place to call to see how they are doing it from Verax. Then we also found two obstacles to this thought. First, Verax's 510K is for testing up to 4 hours prior to transfusion. Second, FDA's document on SCD says that the product is only good for 4 hours, otherwise it is considered manufacturing. We spoke with one person at FDA a while ago and they said it would be okay to SCD the platelets but we are very concerned due to what is in writing. We are a Transfusion Service and not a licensed facility. Thoughts???? Appreciate your comments.

We have been reporting all of ours except for trauma patients where we have units stored in the ED and OR refrigerator or if we never receive a sample and are just giving out O Neg uncrossmatched. The FDA document is pretty clear. In addition, since there are so many checks that occur for the electronic crossmatch at the issue step we feel we could really cause harm if somewhere up stream we had over looked a QA message. The issuing in the computer is the last step. Now obviously during computer down time we would not report those.

I can tell you that at our large university medical center we would not report this one to FDA as long as our Medical Director completed our deviation from standard SOP form. We do report a lot of things to the FDA so I fell we would be okay not reporting this. Do you report units not issued in the computer prior to release? If so, how many do you have a month.

I work at a large facility in central Ohio. We only return plasma into inventory if it has been at room temp for less than one hour. We discard any plasma found in our thawers (which automatically remove plasma from 37C water) unless we know it was there for less than 1 hour. We convert FFP or Plasma less than 24 hours into "Thawed Plasma" and store it for 5 days at 1-6C. These decisions were made years ago based on some articles that were found but I was not there at that time so I don't know the exact references.