[Mediware HCLL for Transfusion]

Thank you Likewine99. Everybody seems to make sure they state that the system isn't perfect. No system is, but I'm just hoping this is not "subdued buyer's remorse" that turned into resignation to a signed, sealed, delivered, and implemented HCLL that's going nowhere. Just kidding!

With current knowledge and experience, would you have picked something different if you had the luxury?

[Mediware HCLL for Transfusion]

Thanks much Donna. I knew you had a lot more than "Hi" to say but your keyboard/mouse probably had their way. Your reply actually puts my questions to rest for now but if new ones arise, I'll be sure to post them here on this thread.

[Mediware HCLL for Transfusion]

Hi QRISTOFIR.

I was actually expecting a little more than "Hi" in response to my question..... But I can return a warm gesture............ HELLO!

[Mediware HCLL for Transfusion]

Is anybody familiar with the HCLL software for Transfusion by a vendor named Mediware? We're in the processing of purchasing it and should be running in a year or so. I'd like to hear from folks with experience using it well before it arrives in a computer near me.

First question is what kind of patient identifiers does it support? SSN, Medical Record Number, Armband Number, or is it fully customizable? I am currently in a gang on a mission to revise our hospital's patient identifying methods.

Thank you.

[time alloted for blood to hang and resume blood transfusion]

You can spike a unit, let it sit for 3hrs & 59mins, then infuse it within 60 seconds -- and still be in compliance with my SOP. I don't know why you'd want to do that, though ...

We ask the nurses to return any unit not totally infused to the patient (for our records).

What's the benefit of returning a partially transfused unit if there was no adverse reaction and if even a single drop in the patient qualifies the unit as "Transfused" in your records?

Please school me if I missed the whole point.

[time alloted for blood to hang and resume blood transfusion]

Great point Deny. For those like us that are yet to implement the use of temp indicators, I guess the next best thing (like we currently do) is to take the temperature when the units return rather than going by the 30-minute rule solely. Granted, this doesn't cover the likely Operating Room scenarios were blood could be left on the table for an hour then placed back in the cooler under ice and comes back to you in temp; but that's why we are in the process of validating the Safe-T-Vue temp indicators now.

I digress...... anybody got any luck with the Safe-T-Vue 6 Temp Indicators? My understanding is that the color changes AT 6, which is one degree to strict to be practical.

[time alloted for blood to hang and resume blood transfusion]

Transfusions should be completed within 4 hours from start time. That said, I believe you can let a unit hang while you resolve an allergic reaction as long as the total transfusion episode does not exceed 4 hours.

For units returned unspiked, the reason why they can't be acceptable after 30 minutes is because if you do, the risk of bacterial proliferation will be transferred to the next recipient of that unit after it has stayed in storage again for God knows how long.

Hope I made sense?

[FDA reportable?]

Oh Yes it is a reportable. The key is that if that deviation went undetected until after the units left your custody, there's a discernible chance that something more serious can also slip through your cracks and that's why the FDA wants to know and also how you plan to plug the cracks.

We often find ourselves trying to justify the deviation after the fact or trying to show how innocuous it truly was, but the fact is an error made it past our process controls and we have to fix the WHY and the HOW

[Sorry...one more cooler validation question]

So, I was looking back through some of the posts, trying to get a sense of something that concerned me when reading it. My practice everywhere I have worked is to send blood in validated coolers with temperature monitors attached (usually Safe-T-Vue). The cooler was only allowed to be out for the validated period of time, regardless of what the temp. monitor looked like if returned after that time. I have seen a number of responses regarding the documentation of temps. every 4 hours. Now of course I do that with all of my equipment in the Lab (we have a continuous monitoring system with charts that can be installed as a back-up if needed), but I have not felt the necessity (even from a regulatory standpoint) to do this with coolers, provided I follow those 2 points (cannot be out longer than validated time, and must come back with an acceptable temp. monitor).

So, can anyone tell me (with reference to regulations if possible), whether it is requried "in addition," to document the temps. every 4 hours (provided your validation time is > 4 hrs.)?

Thanks,

Brenda Hutson, CLS(ASCP)SBB:confused:

I am with you on this one Brenda. If you have validated your Safe-T-Vue indicators to show that they indeed function as expected and you have also validated your transport coolers for a specific time, using the Safe-T-Vue indicators and returning coolers within their validated "keep cool" times suffices and meets that requirement to continuously monitor temps at least every four hours (strictly my opinion). If the indicator will tell you at any time if a unit was exposed to unacceptable temperatures, why isn't that considered continuous monitoring especially when it has been validated to function as expected.

My question to everybody though (since we are just now trying to start using indicators for the first time) is do you perform any form of checks/QC on new lots of indicators before use?

Thanks

Chris

[Storage vs. Shipping/ Validation]

I believe that whoever wrote the 'Store at 1-6, Transport at 1-10' rule was a bit narrow sighted.

Obvious storage is in our refrigerators, but what about the boxes we 'store' the blood in while they are waiting (sometimes for hours!) to be loaded onto a truck? Are they 'in storage' or 'in transport'? When they are IN the truck,we clearly see them as 'in transport'. So, I guess the criteria is based on is really 'is it in a moving state?'. Given that, if the cooler is sitting on the ground, it must remain between 1-6oC. If it is being carried somewhere, it can go up to 10oC. (Ummm, what temp check stickers are we using, 1-6 or 1-10 for these?)

Are we all nuts or what!?

Whatever ... the rule should be rewritten for clarity's sake: e.g. RBC's must be maintained at 1-6oC. However, if allowed to warm up to 10oC for longer than X minutes (hours?), then the outdate must be amended to ____ (24hrs?). If allowed to warm up greater than 10oC, it must be discarded. (Interesting that the current rule states we can't reissue it ... why doesn't it state we must discard it? Do YOU store such units in quarantine until they outdate? We don't either.) This is how it is stated for bones ... it's very clear what to do when.

So, if there is anyone out there who has any control over writing the FDA regulations, can you bring this up at your next meeting please?

I agree. The distinction of Storage and Transport defies common sense because there really isn't any logical reasoning behind why while moving blood is ok at 10degrees but absolutely unacceptable if the same temp while stored. In their defense though, I guess they saw transport as temporary so it was ok to temporarily relax the rules to prevent a large scale wastage of blood. If that's the logic, transport coolers are even more temporary so why this new wave of inspectors calling them storage? Like you said, it should all be 1-6 for the sake of clarity. If inspectors these days are allowed to deploy personal opinions in deciding what's a violation or not, then we may have something else on our hands here.

[Storage vs. Shipping/ Validation]

I went on this quest to find something in writing that now considers transport coolers "temporary storage" but haven't found any treasures yet. I am trying to go with the current industry flow and comply by modifying our practice here but I also hate being a lemming. Can anybody point me in the right direction to that FDA guidance/instruction/new rule? We will be inspected sometime this Fall and I heard nothing about this from the last inspection. Thank you.