Just curious how other donor centers are recording/ tracking the lot numbers of scrubs used during arm preparation-- any input would be helpful. Thanks!

This is something we have not done in the past or currently track.

We have two small centers, collecting less than 20,000 total a year. We don't track this either.

We record the lot # of our prep set and sterile 2 X 2s on the donor health history record. They are entered into the computer, allowing us to search on those fields in the event of any recall.

Currently we record the lot # on a daily QC sheet.

We also record the lot number of arm prep scrubs/swabs on a daily QC sheet.

As well as listing when we open a new lot and put it into use.

We used to record this on a daily QC sheet, but that was so cumbersome. Now we record lot numbers on a log, and record the date they go into service. We log them "out of service" when we start a new lot number. So at any given time we know the inclusive dates that a lot was in use.

We also record the lot numbers on a daily QC sheet.

We have a log with the unit number and all supplies utilized in the collection which includes the item, manufacturer, lot number and expiration date on one side of the sheet. We make kits up with all of the inclusive items so when it is issued to a donor, the date and donor information is also added on the reverse side of the sheet. Daily reviews are performed to insure that any expired items are removed and replaced with indated replacements. The log sheets are made for each box of bag kits prepared. This helps us with any product recall.

I recently had an FDA inspection and that is one thing they noted, that we need to begin recording the scrub lot #. I have since added it on to our Donor Record form. However, we collect only autologous units, and our number of collections are extremely few.