Deb

I'm not aware of any requirement for the Medical Director themselves to review the actual collection records. I'm wondering if this is in reference to CFR 640.3 (a), where it says: The suitability of a donor as a source of Whole Blood shall be determined by a qualified physician .... or by persons under his supervision and trained in deterining suitability......etc Read on in the CFR and there is an explanation of how/when other staff can perform certain duties. Likewise AABB standards indicate the Medical Director is responsible for activities....but they may be delegated to other personnel. Std 1.1.1

Take a look at Harrington Quality Management System...HQMS. It is web-based and you get access to all of the modules. We just implemented the Document Control module. They do have CAPA, Training, Task Management, Dashboard, etc. I'm not real familar with reporting processes and customizing them. The system is not blood bank specific but is implemented in many industries and seems to be pretty customizeable. Worth a look at anyway.

We also use the same specific gravities that you listed.

Terumo also makes a metal clip. Theirs is round as opposed to rectangular.

Sorry, I didn't see your request. I believe we went with a bag of wet ice in the bottom of the cooler, a layer of insulation (i.e., paper or cardboard) the units, insulation and another bag of wet ice on top. If you send me your email address I can send you a copy of our packing configuration--- that is, if you still need it!

We used the ISC coolers as well and now that they are no longer on the market struggled to find a replacement. For units that are being transported from a blood drive back to the center we ended up going with Coleman Coolers (on wheels) from Walmart and coming up with a packing configuration that would successfully cool the units "towards" 1-10 C. We used data loggers at different positions in the coolers when we validated to show that the cooler could successfully handle this and validated the process for 24 hours "just in case" something happened to delay the delivery of the cooler. What I found from validating the ISC coolers and the Coleman is that it usually takes at least 6-8 hours for the temps to drop to below 20 C....and we usually have them back at the center within 4 hours. Really, all you have to show is that the cooler is able to continuously cool the units "towards" 1-10 C.....not that they actually reach 1-10 C during your transport time.

I had asked our Consumer Safety Officer at CBER for a reference within the CFR regarding review of policies. Her reply was that the CFR does not specify annual review of policies.

We are implementing Harrington Quality Management System. It is web based and has CAPA, Training, etc modules as well as Document Control.

Being a cautious person, I would call Ortho and discuss the issue with them. If they have outsourced their service for some reason, I would think they would have communicated it with you.

We used to keep a crash cart in our hospital based donor room, but it was primarily there because we also had RN's performing therapeutic exchanges on patients. That service was transfered and some years ago our organization determined to remove many of the individual service crash carts because there was a lot of maintenance involved and most supplies/drugs were expiring. In any case, none of my staff are trained or licensed to use the supplies on a crash card and the crash team also responds with applicable crash cart supplies. Check with your response team, they probably bring a crash cart with them.

As a collection center that prepares and freezes plasma we also simulated different loads of warm units and freeze times. We used small data loggers placed in alternating positions (front/back or left/right) on each shelf/drawer to map what happened to the temps in each area as the freezer was loaded. We did a single unit on each shelf. Six units all at once. Multiple loads placed in the freezer at different time intervals, and one large load that might simulate after a busy day/blood drive. What we found was that certain places were best for quicker freezing and others were better for maintining the frozen temps. We used water bags to test this. If you want more details, feel free to let me know and I can forward more info to you.

CLSI (used to be NCCLS) has a Tentative Guideline: Temperature Monitoring and Recording in Blood Banks. NCCLS Document 16-T Vol. 6 no. 19 hints that alarm sensors should be tested monthly. 5.3.1(2) Platelet Incubator-Rotator but then uses the term quarterly for blood refrigerator and freezers. I have requested clarification from CLSI, but have not heard back yet.

We are struggling with finding an effective way to keep our apheresis donors warm enough to minimize the vasoconstriction and draw pressure alerts. We've tried the chemical hand-warmers you can purchase but they don't seem to be very effective. I received a suggestion to use a heating pad which I think might be the ticket...but, as we are a hospital blood center, we are encouraged to use 3-prong (grounded) electrical plugs. Most heating pads I see have only the two prong plug. Does anyone have a vendor suggestion ... and/or any other suggestion for keeping our donors warm? Thanks! P.S. .... It's no wonder we have difficulty it was well below zero F today....

Heather, Cliff.... Would you be able to share your document? I would also like to discontinue using the CUE ballot (I know, we are behind the times in this!) you can send it to me at dschue@altru.org Thanks!

The 2007 FDA Guidance for Platelet Apheresis collection defines limits for concurrent plasma collection on pg. 7 point number 4. Trima plasma storage bags have an upper limit of 600 ml. Annual cummulative plasma loss is limited to: 12.0 liters/year if the donor weighs less than or equal to 175 lbs. 14.4 liters/year if the donor weighs greater than 175 lbs. I would call my CaridianBCT Rep (or TerumoBCT rep - since they merged) for details on how Trima calculates the volumes it collects. They can help you establish the configurations for plasma collect based on your collection goals, regulatory requirements, and what Trima is labeled for collecting.