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With regards to cap standard TRM.42470 

What levels of validation are people performing? I can see this from 2 angles, 1 is the risk of bacterial growth should anything already be in the bag, the second is the risk of reduced blood viability from 30 minutes extra of been out of storage. The latter I would imagine would be extremely difficult to validate, in the UK the 30 minute rule is an accepted standard on which we have never been required to validate this.  

Is a simple temperature check ok? should quarantine of the unit be performed with microbial culture? as has been suggested by one of my staff, however this would remove the unit from use for 3 days and possibly result in waste of the unit anyway. 

TRM.42470 Acceptance Back Into Inventory Phase II
There is a written procedure, validated by the laboratory, for accepting blood/blood
components back into inventory after they have been issued.
NOTE: The procedure must include steps to verify the integrity and appearance of the blood/
blood component and maintenance at appropriate temperatures.
The steps and criteria defined in the procedure for acceptance of units back into inventory,
such as the use of transport containers

Thanks Steve

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We take the temperature of the unit when it is returned no matter how it was sent.

This has become an issue here in the US and the FDA considers these units 'in storage' if they are not moving so the restriction is 1-6oC.

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12 minutes ago, JPSCANNELL f. CROKE said:

We take the temperature of the unit when it is returned no matter how it was sent.

This has become an issue here in the US and the FDA considers these units 'in storage' if they are not moving so the restriction is 1-6oC.

This is one of those things that make me glad I don't do inspections any longer.

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I read a journal article a while back that looked at the detrimental effects to blood if left out at RT for different amounts of time and then but back in the fridge.   They did this multiple times to each unit of blood.   The result of their study was that the 30 minute rule, if there ever was one,  could be changed to the 1 hour rule.   I thought that was really interesting.  

 

Anyway, we take the temp of every red cell returned.   If OK we put it back into inventory.   The LIS will prompt for integrity/appearance acceptability and return temp.

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We did a validation a few years ago where we set a unit on the counter in lab, ICU, and one of the other patient locations.  We took the temperature of the unit every 5 minutes.  We found that the temperature was within range in all locations tested for at least 30 minutes, so we validated our 30 minute rule.

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The problem is not just that the unit is or is not within particular temperature range before being put back into use, but rather the unit has not been monitored while not in the care of the blood bank.  A unit sent to, say. OR in a cooler, may have been "checked" when it got into the theater -- and left for a time on the counter (maybe next to an incubator!) -- returned in the cooler on ice you will never know if it was kept at a proper temp all that time.

And how do you really "validate" a unit's potential for a "detrimental" effect?  Transfuse various units left on a counter for different times and see which patients have a bad outcome?

Scott

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11 minutes ago, SMILLER said:

The problem is not just that the unit is or is not within particular temperature range before being put back into use, but rather the unit has not been monitored while not in the care of the blood bank.  A unit sent to, say. OR in a cooler, may have been "checked" when it got into the theater -- and left for a time on the counter (maybe next to an incubator!) -- returned in the cooler on ice you will never know if it was kept at a proper temp all that time.

And how do you really "validate" a unit's potential for a "detrimental" effect?  Transfuse various units left on a counter for different times and see which patients have a bad outcome?

Scott

This was my point exactly, without a full on viability study, the likes of which would be far out of the realms of possibilities for a hospital lab, I cannot see what validation can be done. Just proving temperature does not mean that one that exceeded say 10oC for 10 or 15 minutes is still not a viable unit.

Studies have been done on this matter, what is the point of individual labs trying to validate it, should we validate expiry dates too? of cause not we have to go with what the suppliers have validated them for and trust the information we are given. 

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On 3/13/2019 at 9:04 AM, TreeMoss said:

We did a validation a few years ago where we set a unit on the counter in lab, ICU, and one of the other patient locations.  We took the temperature of the unit every 5 minutes.  We found that the temperature was within range in all locations tested for at least 30 minutes, so we validated our 30 minute rule.

Was the bare unit directly in contact with the counter or was the unit within some kind of overwrap or secondary container?

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Here in Canada, the CSA standard 10.10.5 states:

CSA 10.10.5

A blood component that has been returned to the blood centre or transfusion service shall not be rereleased unless

a)      for red blood cells, there is at least one remaining sealed segment of integral donor tubing attached to the blood bag or available to the transfusing site. Previously removed segments may be used after confirming that the tubing identification numbers on both the removed segment(s) and the blood bag are identical;

b)      there is documentation to

     a.       indicate it is being re-released; and

     b.      confirm that it has been visually inspected before release;

c)       a suitable temperature-monitoring system indicates that the blood component has not reached an unacceptable temperature since being released or, in the absence of a temperature-monitoring system, that the blood component has not been outside of a controlled environment for more than 60 min (measured per occurrence, not cumulatively); and

d)      the blood bag closure is undisturbed.

I know that isn't necessarily helpful for you currently, but this was new in the last revision.  Perhaps changes coming soon to other countries?

sandra

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On ‎3‎/‎14‎/‎2019 at 11:21 AM, Dansket said:

Was the bare unit directly in contact with the counter or was the unit within some kind of overwrap or secondary container?

The unit was just sitting on the counter.

 

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Quote

 

Place a Blood Temp Indicator on the bag when it leaves the BB and inspect the indicator and take the temp when it is returned.

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Posted (edited)
20 hours ago, ANORRIS said:

Place a Blood Temp Indicator on the bag when it leaves the BB and inspect the indicator and take the temp when it is returned.

But what is the acceptable temperature limit for a 30 minute excursion? If it was in a validated transport box with a logger inside that remained between 1oC and 6oC then it wont be considered to have left cold storage hence the 30 minute rule wouldn't apply.  We have transport boxes validated for 8 hours that we send to OR. So that fact that a limit to "30 minutes rule" exists suggests that the unit does not need to be kept at cold storage temperatures, but what would be acceptable? temperature for the unit to reach for 30 minutes? For example UK guidelines state that a unit of PRBC can be used with temperature excursion of up to 10oC for up to 5 hours. 

Some interesting info in this document for the UKBTS reviewing the evidence of various studies,

https://www.transfusionguidelines.org/document-library/documents/change-notifcation-no-33-2016/download-file/Change Notification No 33 2016 - Removal of red cells from a controlled temp.pdf

Ramirez-Arcos and colleagues from the Canadian Blood Service reported on two studies
using red cells in SAGM. In the first study, a single five hour exposure to room temperature
showed no immediately significant effects on the in vitro quality of the red cells, although six
days after the exposure ATP and K+ levels were significantly lower than in unexposed
controls[22]. In the second study, units were exposed to room temperature for 30 minutes
on each of five separate days, and no significant effects on in vitro red cell quality markers
were reported[23].

 

Steve

 

 

Edited by srichar3

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3 hours ago, srichar3 said:

But what is the acceptable temperature limit for a 30 minute excursion? If it was in a validated transport box with a logger inside that remained between 1oC and 6oC then it wont be considered to have left cold storage hence the 30 minute rule wouldn't apply.  We have transport boxes validated for 8 hours that we send to OR. So that fact that a limit to "30 minutes rule" exists suggests that the unit does not need to be kept at cold storage temperatures, but what would be acceptable? temperature for the unit to reach for 30 minutes? For example UK guidelines state that a unit of PRBC can be used with temperature excursion of up to 10oC for up to 5 hours. 

Some interesting info in this document for the UKBTS reviewing the evidence of various studies,

https://www.transfusionguidelines.org/document-library/documents/change-notifcation-no-33-2016/download-file/Change Notification No 33 2016 - Removal of red cells from a controlled temp.pdf

Ramirez-Arcos and colleagues from the Canadian Blood Service reported on two studies
using red cells in SAGM. In the first study, a single five hour exposure to room temperature
showed no immediately significant effects on the in vitro quality of the red cells, although six
days after the exposure ATP and K+ levels were significantly lower than in unexposed
controls[22]. In the second study, units were exposed to room temperature for 30 minutes
on each of five separate days, and no significant effects on in vitro red cell quality markers
were reported[23].

 

Steve

 

 

We  dropped the "30 min rule" years ago and use actual temp only with Blood Temp Indicator and take temp manually when returned.

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18 hours ago, ANORRIS said:

We  dropped the "30 min rule" years ago and use actual temp only with Blood Temp Indicator and take temp manually when returned.

But what temp do you consider acceptable for return? what evidence did you use to validate this? If you state it must still be at 1oC to 6oC, you may be throwing units away that are still fit for use. As CAP are asking for a validation then it needs to be evidence based, opting for 1oC to 6oC would be the easy option but I dont want to be throwing away units that we can still use.  :unsure:

Are there any standards from AABB regarding this? I have a copy in the post but not sure it will come before our CAP inspection next month. 

Thanks Steve

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