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Return to Blood Bank policy


jchp

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I am going to make the assumption you are asking about red cell units and not plasma based units as I answer this question.

3.0 Procedure

3.1 Returned units must not be reissued for transfusion unless the following conditions have been met:

3.1.1 The container closure has not been penetrated or entered in any manner.

3.1.2 Red cell components have been maintained continuously between 1 and 100C. Red cells that have remained out of a monitored refrigerator or a validated cooler for longer than 30 minutes are not suitable for reissue; beyond that time, the temperature of the component may have risen above 100C. Blood must never be stored in unmonitored refrigerators in other areas of the hospital. The ports on the unit must be intact, and all labeling on the unit must be intact. The blood bank requisition must also be attached to the unit.

3.1.3 At least one sealed segment of integral donor tubing remains attached to the red cell component, if the blood has left the premises of the hospital.

3.1.4 Records indicate that the blood has been inspected (refer to policy BB-324) and that it is acceptable for reissue.

3.2 Return inspected and acceptable units to the appropriate shelf of the Blood Bank refrigerator.

Hope this is what you were looking for. :)

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Our inspector said that we should verify that the temp of the unit (rbcs) was between 1-10degrees C. Our current policy is that it has to be returned w/in 30minutes and be cool to the touch. We are a small hospital, so we do not issue in coolers at this time.

If we go to coolers/ containers, how do you validate them?

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The SOP I included a portion of is based on the standards. I am looking for the reference we have indicating the rise in temperature of 1 degree C for every 5 minutes out of refrigerated temperature that the 30 minutes is based upon. We do not use coolers at our facility either, by the way. I will get back to you on the source for the temperature rise.

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A unit of packed RBCs at room temp. will exceed 10oC in well UNDER 30 minutes. No where in standards will you find the 30 minute window mentioned. All you will find is they must be returned within temp and that is 1 - 10oC.

I've mentioned this in posts quite some time ago. The 30 minute window came about back when whole blood was stored in glass bottles and it did take 30 minutes for them to exceed the 10oC threshold.

:confuse::confuse:

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As a small hospital that does not use transport containers or floor refrigerators, would it be

better to just dispose of returned units? They are not allowed to store units outside of the lab, and must

be ready to infuse before getting the blood.

If the unit is left at room temp. they probably are too warm very quickly.

The unit return rate is less than 2 per year. Should we just not re-issue, to avoid having to verify the temp of the unit?

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Given that you are talking about 2 wasted units a year, I think it would be very practical to just discard those units that have been issued then returned to Blood Bank, rather than go through the trouble and expense of purchasing and validating transport coolers.

Donna

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I had confirmation from AABB that you must document either the actual temperature of the unit on return or have a documented method (validated cooler or validated indicators) that ensures the unit is between 1- 10 C on return before the unit can be reissued. We tested blood (expired, of course!) on the counter of our trauma bay one time and discovered that it took a unit of blood that started at 3 C about 7 minutes to rise above 10 C. We changed our policy to not accept returns from the trauma bay.

I think we would waste a significant number of units if we changed our policy to disallow returns (unless we could change nursing culture...), so I am looking at infrared thermometers for quick temperature readings on return (there is another thread about these). The biggest problem is where I can document the data.

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We practice that a unit of PC's can be returned within, and up to, 30 min of the time of issue. Apparently not a good practice especially given the info provided by John C Staley and adiescast. If you don't mind me asking; How does everyone practice receiving PC's from your providers? It would seem that each unit would have to be processed very quickly in order to maintain temp. Lets say specifically 50 units of PC's.

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50 is more units than we keep in stock :D. We do have situations where we will receive 18 to 20 units. With a single tech working on this we manage to have everything in the refrigerator within 4 or 5 minutes of receipt. Primary objective is to place units into holders and onto a shelf so the information is visible through the glass door. Unit numbers are checked without the need to open the door this way. Segments are then pulled for retype a few units at a time and placed into a labeled tube until segments from all units have been pulled for retype testing. This minimizes the time the units are at room temp. From some of the time frames mentioned in earlier posts I may need to do a study to try to find a "realistic" time units can be out at room temp. Anyone aware of any studies similar to this not using coolers for transport? An area hospital's blood bank and lab are remotely located from the hospital and use a pneumatic tube system to transport units to nursing units. I will check with them and see if they have any information.

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50 is more units than we keep in stock :D. We do have situations where we will receive 18 to 20 units. With a single tech working on this we manage to have everything in the refrigerator within 4 or 5 minutes of receipt. Primary objective is to place units into holders and onto a shelf so the information is visible through the glass door. Unit numbers are checked without the need to open the door this way. Segments are then pulled for retype a few units at a time and placed into a labeled tube until segments from all units have been pulled for retype testing. This minimizes the time the units are at room temp. From some of the time frames mentioned in earlier posts I may need to do a study to try to find a "realistic" time units can be out at room temp. Anyone aware of any studies similar to this not using coolers for transport? An area hospital's blood bank and lab are remotely located from the hospital and use a pneumatic tube system to transport units to nursing units. I will check with them and see if they have any information.

Deny,

Can I ask you when do you enter the units into your computer system during your process? When we receive PC's we enter the units into the computer, pull segments (one for testing and one for reserve), place the units in the refrig, then compare what we have on screen to the invoice, then test the segments, entering the results on another screen. We can peice-meal the process five units at a time while leaving the remainder on ice in the transport box. This process can expose the PC's to RT for longer then 7min if not done a few at a time.

But hears a fact that I was just realizing; when the PC is tranfused it can take up to 4hours; extremely long exposure and yet practiced regularly. There seems to be some contradiction between recommendations of storage and RT exposer temp and actual practice. I am wondering if these temp recommendations are takiing into account the potential for "time/ temp abuse" over the course of the unit's shelf-life. Time/temp abuse being that the unit will be out at RT for given periods of time and then placed back in the refrig repeatedly.

Sorry for the lengthy post but what do you all think?:):):)

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We use the packing list to match unit ID's through the refrigerator door. Once they are all checked and accounted for, the packing list is used for computer entry. We realized the extended time the units were remaining at RT while pulling segments, data entering, etc. and changed the process to try to minimize the RT exposure.:)

The 4 hour window for transfusion we abide by is related to the unit potentially being exposed to bacterial contamination when nursing "spikes" the bag to begin transfusion. As I understand it 4 hours was the max time allowed before significant bacterial growth could occur. This does beg the question of what about immunocompromised patients? A patient displaying a normal immune response should be able to handle the "slight" possible contamination due to spiking of the unit. What about an immunocompromised patient?:confused:

Not sure what the basis for the 10 degree C max temperature on a returned unit is based upon. Anyone know the source of this particular temperature or is it an arbitrary number someone assigned to the return process?:confused:

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jchp,

As a smaller hospital we are in a similar situation. Our "return without transfusion" situation amounts to only a couple of units per year. I am looking at two possible methods of meeting the 21 CFR 600.15(a) requirement. One is a product available from William Laboratories called the Safe-T-Vue designed just for this sort of use. An indicator is applied to each unit and activated as it is issued for transfusion. It functions as a permanent color change indicator if the temperature limit is exceeded. Three versions available (6 degrees C, 8 degrees C, and 10 degrees C).

The other method I am investigating is an IR thermometer. My only concern is the accuracy of these units (the one I pulled up to look at is a + or - 2 degrees C accuracy). This may not meet the need. When you look at the cost of a unit of PRBC's at a couple hundred $ U.S. I am guessing the indicators may be covered by this cost per year depending upon the volume of units you issue. Anyone have any thought on either or both of these methods proposed? :confused:

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I found an IR thermometer that is accurate to within +/- 0.5 C at ThermoWorks listed for $96.00. Took both options to the lab manager to see which option sounded better in her opinion. She is having materials management cut a PO for the IR thermometer. I will let you know how well it works, etc.

Our COLA inspector was not satisfied with the multi-year national study American Red Cross performed on their transport boxes to guarantee temperatures were maintained during transport of blood products. The inspector suggested we document that the frozen units were received on dry ice, PRBC's were received on wet ice, and platelets box is temperature checked with a thermometer upon opening of the transport box and the temperature documented on the packing lists. :rolleyes::rolleyes: OK whatever they want I guess. Hoping thr IR thermometer will allow us to record specific temps for a while upon receipt and perhaps we can discontinue this process :whew:(not holding my breath though :D)

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We practice that a unit of PC's can be returned within, and up to, 30 min of the time of issue. Apparently not a good practice especially given the info provided by John C Staley and adiescast. If you don't mind me asking; How does everyone practice receiving PC's from your providers? It would seem that each unit would have to be processed very quickly in order to maintain temp. Lets say specifically 50 units of PC's.

When we get our large shipment, the units are checked against the packing list while still in the iced cooler. Then they are moved to a segregated space in the refrigerator. We take them out a few at a time to pull segments and do the computer entry, then put them back in the "unprocessed" area of the refrigerator while we retype them. Plasma and cryo units are also placed immediately in the freezer and brought out a few at a time for computer entry.

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I had confirmation from AABB that you must document either the actual temperature of the unit on return or have a documented method (validated cooler or validated indicators) that ensures the unit is between 1- 10 C on return before the unit can be reissued. We tested blood (expired, of course!) on the counter of our trauma bay one time and discovered that it took a unit of blood that started at 3 C about 7 minutes to rise above 10 C. We changed our policy to not accept returns from the trauma bay.

I think we would waste a significant number of units if we changed our policy to disallow returns (unless we could change nursing culture...), so I am looking at infrared thermometers for quick temperature readings on return (there is another thread about these). The biggest problem is where I can document the data.

Who did you get the confirmation from for the 1-10 return temperature? We have been told that if a unit is not actually leaving your physical building, but simply going to a different floor, it is not considered transport and must stay between 1-6. We have been working on this situation too as we have done away with the 30 minute return rule.

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When we get our large shipment, the units are checked against the packing list while still in the iced cooler. Then they are moved to a segregated space in the refrigerator. We take them out a few at a time to pull segments and do the computer entry, then put them back in the "unprocessed" area of the refrigerator while we retype them. Plasma and cryo units are also placed immediately in the freezer and brought out a few at a time for computer entry.

adiescast,

Thank you for the info. Do you have a seperate receiving area in your BB. I used to work at a BB that had a seperate area for receiving products and I'm thinking that you may have the same situation.

There seems to be two temp criteria for PC,s based on storage and transfusion. The storage criteria is somewhat stringent but based on what? Where the transfusion critia is based on the potential of bacterial comtamination when the bag is spiked and it's growth potential to clinically significant levels during the course of transfusion, as Deny has mentioned. Do you know what the storage temp criteria is based on? I had mentioned time/temp abuse; and of course I realize that bacterial growth is the consideration here as well but the bag is not spiked and not at room temp for extended periods of time, so why the stringent temp requirements, especially when we consider the collection process as well. And can I further say that if there was some bacterial contamination of the unit at the point of collection wouldn't it be better for the recipient if we knew the unit was indeed contaminated prior to transfusion?:):)

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We use the packing list to match unit ID's through the refrigerator door. Once they are all checked and accounted for, the packing list is used for computer entry. We realized the extended time the units were remaining at RT while pulling segments, data entering, etc. and changed the process to try to minimize the RT exposure.:)

The 4 hour window for transfusion we abide by is related to the unit potentially being exposed to bacterial contamination when nursing "spikes" the bag to begin transfusion. As I understand it 4 hours was the max time allowed before significant bacterial growth could occur. This does beg the question of what about immunocompromised patients? A patient displaying a normal immune response should be able to handle the "slight" possible contamination due to spiking of the unit. What about an immunocompromised patient?:confused:

Not sure what the basis for the 10 degree C max temperature on a returned unit is based upon. Anyone know the source of this particular temperature or is it an arbitrary number someone assigned to the return process?:confused:

Deny,

Nice process. I'm wondering when you pull the segments from the units. I'm imagining the refrigorator door opened whiled segments are pulled and lable a few at a time; and if so how do you keep track of the units that still need segments pull. Also, feel free to express any ideas related to the post I left for adeiscast.:):)

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I must make a disclaimer that I work for neither AABB nor FDA, so if you really want to know what they think precisely, I would recommend that you check with them.

The 1-6 C for storage and 1-10 for transportation are regulatory and standards settings by FDA and AABB. I don't know the history of the decision to use these ranges. What AABB and FDA disagree on is what constitutes "storage" and "transportation." FDA has been very stringent in making this distinction in my experience. Anything in a cooler that will sit in one location (like an OR) for any length of time is "storage". AABB Standards has a statement about validating coolers to "transport" components issued for transfusion for the appropriate "transport" temperature.

My understanding is that units taken from the blood bank to the floor without a cooler for transfusion in the near future are "in transport" while units that are taken in a cooler to be transfused over a more extended period of time are "stored" in the cooler. The units in the cooler must be maintained at 1-6 C. The units outside the cooler must be maintained at 1-10 C. I think the primary difference is the intent to mimimize the length of time the units spend at >6 C over their life span. Transport is expected to be short term and temprary, while storage is longer term or life time.

The actual AABB Standard for return states "The appropriate temperature has been maintained." This means that my earlier comment may have been incomplete, since the appropriate temperature may be 1-6 if the units were issued in a cooler for longer term storage. I was referring to units issued for immediate (started within the hour) transfusion. What I got confirmation from AABB accreditation about was that relying on a 30 minute time frame for acceptance of returned units is not compliant with the Standard.

We do not have a physically separated area for receiving. I have a counter that I designated for that use that is used for other things when we are not receiving blood. I do have several shelves designated in a refrigerator, freezer, and platelet incubator for recently received blood products that are not ready for patient use.

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What adiescast said in the previous post makes as much sense as the sometimes vague regs can. I do not have any additional knowledge to add to the great explaination given.

As far as pulling segments for retypes goes, we enter the refrigerator and pull the segments and a unit ID sticker from the back of the unit to label the "primary tube" with. The units are simply moved a bit physically on the shelf in the refrigerator to help the tech keep track of which units have had segments pulled and which have not. The refrigerator has a door alarm that sounds after the door has been ajar for more than 90 seconds. The "game" the techs play is pull segments and labels and get the door closed quickly to beat the alarm (it is annoying). Result is minimal time the door is open subjecting the units to a temperature increase. Hope this helps.

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OK let me rephrase as I did not mean to be offensive and I think I was. What adiescast said makes MORE sense than the vague regs. That was what I was thinking as I typed the first reply, but my fingers obviously had a mind of their own. Sorry if I offended :redface::o

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We have transport coolers for "storage" in OR, ICU/CCU, ER and anyplace else that might need more than 1 unit issued at a time. The coolers are from Minnesota Thermal and have been repeated validated and are very stable 1-6C.

We place all RBCS in the refrig upon receipt and only remove a few at a time to input into computer and pull segments, after which they are returned to refrig. Testing is done and then most units are tagged as "retested" in frig and then moved to "avail" shelves in date order. They seem to stay nice and cool as long as you only work with 4-6 at a time. We check the computer entrys against the shipping document after the units are in the computer.

For returned units, we have a possibly weird policy, but it has worked fairly well for us. We take a returned unit and immediately place a Biosynergy HemoTempII on the unit and place it in the refig. We set a timer for 5 mins - no more. If the unit will show a temp on the indicator within 5 mins, we accept it back into inventory - if not, it is discarded. The only exception would be if the floor could still give the unit within the original 4 hours of the issue time. We hold the unit until they can restart - but only if they can infuse within the decreased time. It happens sometimes that they just need something else signed or fixed and then they can get the unit started.

The temp indicators have allowed us to save a few units, but the majority still have to be discarded, because, believe me - those units warm up fast during handheld transport. We are attempting to replace the indicators with an IR therm, but that is in validation right now and I don't know if it is going to be as stable or reliable as the indicators. IR therms seem to report a wide range of temps depending on how you use them. Best practice so far - hold the IR therm very close to the unit (possible even touching it) in any area where there is no paper or tape (Yeah, I know - all of 2 inches somewhere on the back of beyond!) and take 3-4 readings and average them.

Hope this helps if anyone is interested.

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