Hello everyone!

 

My facility has a refrigerator in the OR.

 

The temps are taken daily by the OR staff.  The Daily temperature record is returned to the Blood Bank at the end of the month.

 

I noticed today that temps were not documented for one day.  I generated a report that indicated four (4) units of RBC had been issued to the OR and then returned to the BB later that day.

 

Fortunately, the units are still in our inventory and have been quarantined physically and electronically.

 

My question to you all is this:  if the chart and the event log on the refrigerator are reviewed and no abnormnal events noted, can the units be released to inventory?

 

My instinct is to discard the units but I wanted to query the group for some advice.

 

Thank you!

Go with your gut instinct and discard them. They are probably fine because the chart looks good, but I'm a big fan for being better safe than sorry. The refrigerator is hooked up to some type of remote alarm if it goes out of range, correct?

Hi Terri,

 

Yes, the refrigerator is indeed hooked up to a remote alarm.

 

Thanks for the reply!

I agree and disagree with Terri - you can make a case that the units were stored correctly.  The feds would say you did not follow procedure.  I'd hate to have to defend it in court as juries are notoriously ignorant.  Better to eat them and use the incident as a means for better compliance with regulations.  The lost $$$ may or may not concern your administration.  Try billing them to the O.R.

 

I have a sporadic day when my BB temps are missed (maybe 2x/yr).  I document that the chart is fine and no alarms sounded; we are staffed 24/7.  Haven't had a problem with inspectors on this, even the feds . 

 

I really have a problem with OR refrigerators - there is no way to document that the units haven't been removed and then returned to the refrig.  You can put the temp monitors on them.  I have been that route in the past and the units always came back as compromised.  Administration always backed the OR even when we put parallel monitors on units we kept in the BB to prove that they were viable.  I've also seen residents just taking blood out and hanging it - paperwork be damned!!

 

This is one example of why the FDA does not want the Red Cross to accept returns after distribution - ARC can't vouch for the the maintenance of storage compliance when the blood is not under their control.

 

A lot of words but no real help to you I'm sure. 

I agree with David. It has been YEARS since we had a refrigerator outside the blood bank for blood storage...for this very reason.

However, if you have constant temp monitoring on the refrigerator in your OR, I would probably not discard the units.

I am inclined to say that it would be easier to defend a final disposition of discard vs returning to general inventory...

I'm with kirkaw. Blood component storage monitoring compliance is tracked either by the continuous monitoring device you have employed (paper chart or electronic system) or the 4-hour manual checks. The daily temperature check is mostly a "function check."

 

I would document with nonconforming event/occurrence/incident (whatever you call it) report and include the details from your chart/device. Make sure the OR manager gets a copy.

I'm SO glad we don't have one of these.

 

 

OK: chart/alarm shows temp stayed within range, temp was recorded once during the day. Keep the blood.

 

Not OK: chart/alarm shows temp stayed within range, temp was not recorded once during the day. Throw away the blood.

 

I kind of like Dave's point "Better to eat them and use the incident as a means for better compliance with regulations." However, I don't see a difference in how the blood was stored in the 2 scenarios, aside from a note on a logsheet, so I side with goodchild and kirkaw. The real issue, as Dave continued, is that the units could have been taken out of the fridge, sat and cooked for half a day on a counter, then put back in. In either scenario you wouldn't know it. 

 

There's my non-answer. Throw them away if you want to make a point to the OR, but I see no difference in safety whether someone recorded a random temp or not.

Thanks so much everyone for the feedback!

 

I have only been at my facility for about a month now and this exact incident has not occurred or at least there is no record of it.

 

One scenario that I can not help but toss around in my head is this:  what if this missing temperature recording involved the BB refrigerator in the BB where available inventory was stored?  There is no doubt in my mind that we would be finding every way possible to justify keeping the inventory.  This OR situation is not much different.

 

Yes, I agree there is the issue of how the blood is handled once in the OR's hands but that is happening every time we issue blood to that location.  Do I like it?  NO but it is something that I have to live with and the alternative of coolers gets me red in the face lol

The Joint Commission frowns upon refrigerators in OR. Nothing in writing, but every inspector asks me about it, and when I say no (emphatically!) that I don't have one, they are happy. As David states above, they could take blood out of the refrig and put it back and you wouldn't know it. We have a surgeon who is always pestering for one, saying "I just want access to blood when I need it". He's made enough noise to Administration that now I have to do coolers...just for him. Which makes me as red in the face as you Maureen.

You can always get one of the blood bank vending machines - If you have a compatible BBIS, the machine does the electronic xm (when appropriate) and dispenses the unit and records it on your BBIS.  I think this is the best thing since sliced bread.  My OR wants cooles and I am adamant (to the point of resignation) to not be a party to them.  I told he OR if they get the vending machine I'd maintain it (of course I have to get a BBIS before I can do that.)

I, too, fully support the BB vending machines.  Our sugical schedule does not warrant one, though.  We are not a high volume blood bank.  I am an IT geek and love anything that technology can do to make our jobs safer.

Hello everyone,

 

The Medical Director decided to discard the units.  He is FDA-fearing

We have 11 remote refrigerators around our facility.  Most wastage occurs in the operating room areas, especially the fridges in the two CVOR suites.  Because of this, we decided a few months ago to pilot a new process for the OR's.  They have been very motivated to reduce wastage but very frustrated with the rate at which the temp indicators turn color on their red blood cells.  We acquired a bunch of small, conventional coolant gel packs and we started to sandwich each red blood cell unit between two of them and wrapping with a rubber band.  We positioned the unit label, tag and temp indicator in such a way that the unit could be checked before storing it in the OR fridge.  We send the blood to the OR through the pneumatic tube (which sometimes results in slight delays of someone retrieving them.

 

After several months, we have seen significant reduction in the temp indicators changing (wastage) and it was relatively easy to train the OR staff to be compliant with this.  They will sometimes take the unit out of the gel packs before putting it in the fridge (along with the get packs) so they can send the unit back to blood bank in the gel packs if they don't transfuse it.  This may all sound cumbersome but it has been generally successful and much cheaper than throwing away units of fresh O Neg!

Remote monitoring is the way to go.

 

Nowhere I have worked has relied on anyone other than blood bank staff to monitor temperatures - it's just not worth it.

I agree with David. It has been YEARS since we had a refrigerator outside the blood bank for blood storage...for this very reason.

However, if you have constant temp monitoring on the refrigerator in your OR, I would probably not discard the units.

 

My blood bank/surgery is also small, with very little usage but I still think it is the way to go - BB Vending machines.  I talk about these a lot and most folks look at me askance.

Hello everyone!

 

My facility has a refrigerator in the OR.

 

The temps are taken daily by the OR staff.  The Daily temperature record is returned to the Blood Bank at the end of the month.

 

I noticed today that temps were not documented for one day.  I generated a report that indicated four (4) units of RBC had been issued to the OR and then returned to the BB later that day.

 

Fortunately, the units are still in our inventory and have been quarantined physically and electronically.

 

My question to you all is this:  if the chart and the event log on the refrigerator are reviewed and no abnormnal events noted, can the units be released to inventory?

 

My instinct is to discard the units but I wanted to query the group for some advice.

 

Thank you!

In my BB we would have discarded them but not for the reason you mentioned.  We use individual temperature indicators anytime a unit is issued to a remote storage unit.   No indicator or activated indicator = discard.  

We have 11 remote refrigerators around our facility.  Most wastage occurs in the operating room areas, especially the fridges in the two CVOR suites.  Because of this, we decided a few months ago to pilot a new process for the OR's.  They have been very motivated to reduce wastage but very frustrated with the rate at which the temp indicators turn color on their red blood cells.  We acquired a bunch of small, conventional coolant gel packs and we started to sandwich each red blood cell unit between two of them and wrapping with a rubber band.  We positioned the unit label, tag and temp indicator in such a way that the unit could be checked before storing it in the OR fridge.  We send the blood to the OR through the pneumatic tube (which sometimes results in slight delays of someone retrieving them.

 

After several months, we have seen significant reduction in the temp indicators changing (wastage) and it was relatively easy to train the OR staff to be compliant with this.  They will sometimes take the unit out of the gel packs before putting it in the fridge (along with the get packs) so they can send the unit back to blood bank in the gel packs if they don't transfuse it.  This may all sound cumbersome but it has been generally successful and much cheaper than throwing away units of fresh O Neg!

 

 

Very interesting procedure.  How come they don't just leave the units together WITH their gel paks while putting them in the refrigerator, I wonder?  The units today are small enough that they change temp very fast, especially if someone is handling them.  This seems like a good answer to help with that problem.. Has this procedure been through an inspection yet? 

Hello all,

 

a bit late, but if everyone did everything right every time, we would still have < 100 % safety rate.  Having said that, I am not comfortable with the added guess work of not knowing whether or not those units of rbcs were taken out of the appropriate temperature/OR regfrig for who knows how long (ooops!!!) and then returned to Blood Bank, deemed ok. I am big on being a good steward of company's $$$, and unnecessary wastage makes my stomach hurt  .  However, the patient's safety is my ONLY concern here.  Forgive me, but I do not see how the charts, monitors, and alarms can tell me the truth about whether those units spent their time in New Orleans in June or Chicago in.. well you get the point.  At least the irreversible temperature indicators (firmly attached and not disturbed) give me some level of assurance.  Any one with better/new process, please share.  Happy Friday!!!  No spell checks please  .

 

Connie