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>30 MINUTE RULE


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I would like feedback for the following:  Unit is issued and NOT spiked.  30 min have elapsed & something happens that causes the transfusion to be stopped/ delayed but it is possible the situation will be fixed so that the unit can be transfused within 4 hrs from issue.  ( ie. IV infiltrates)  We would like for the BB and Nursing to have some discretion on these cases so that units aren't summarily discarded.  I have researched & read feeds on here that give us some grounds for altering our policy.  I would like to know if anyone else does this and any problems or unanticipated consequences.  Please state the size of your facility and if you are not in the US, please say so also. 

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See the attached article, Debunking the 30-Minute Rule, in the May 2010 issue of AABB News. The criteria for re-issue of red blood cell components returned unused by Nursing is temperature, not time. I use temperature of the unit in a 523 bed facility and a 145 bed facility in the US to determine if unit can be re-issued.

AABB news may 2010.pdf

Edited by Dansket
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Our policy is to start the transfusion promptly and to infuse the whole unit within 4 hours from start of transfusion.  The RN is supposed to call the BB for guidance in such cases when start of transfusion is delayed.   I would advise the RN to transfuse the unit within 4 hours from issue or if not possible they should return the unit and we will discard.    We are a large US hospital system and transfuse > 10,000 units/month. 

Edited by R1R2
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My policy is no returns after 15 minutes. If the unit is spiked (or not) and the transfusion is delayed it can still be given to the same patient it was released for as long as the transfusion is completed within 4 hrs of release from the BB. Why not?

I am in the USA in a 40 bed/25 bed critical access hospital.

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We do not accept returns unless the order has been cancelled by the physician or the patient has expired. Nursing policy is to keep the unit up there and transfuse it within 4 hours from issue time.

If the unit does come back for one of the 2 reasons above, we take the temp. If 10 or below, we accept it back into inventory. If above 10 it is discarded. We use return temp, not time frame. From what I understand you can use a time frame, but you have to do a validation to see what the acceptable time frame is for your facility. 30 minutes would absolutely be out of temperature range.

In the USA, 350 bed hospital.

Edited by tbostock
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If the start of the infusion is delayed, but nursing says they can get it in within 4 hours of checkout, we tell them to do it. Nursing policy states that infusion must start within 15 minutes of checkout. We accept returns for reissue based on temp only - must be <10C or the unit is discarded.

 

US hospital - 150 beds

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Ditto - we use temp not time. The 30 minute rule came about from big fat units of whole blood. We find packed cells hit 10o around 15-18 minutes. We ask the floors to keep the blood if delays are encountered, so long as they can finish within 4 hours of issue. It's always a stuggle in comprehension for nursing that it's OK for the unit to sit on their counter for a hour before hanging, but not OK for it to be sent back to us after 30 minutes, stored in the fridge for 30 minutes, then reissued.

US - 250 beds

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Ditto what Dr. Pepper said: we use temp not time.  We also find RBC units to exceed 10C in 10-15 minutes.  We measure the temp on return.  If over 10C we notify the RN that the unit can be reissued for transfusion to that patient only if transfusion can be completed within 4 hours of the origianl dispense time.  We document the required time for completion on the transfusion record with the following:

 

Reissued Unit. Transfusion must stop at:

Date_______________ Time_______

RN notified:_____________               by:

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For those who responded that they use temperature as the criteria for return to inventory, how are you taking the temperature?  We use Safe-T-Vues to monitor temperature but it sounds like some of you are taking actual temps.

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For those taking the temp, do you validate (presumably annually) the device you take the temp with?

 

We chose to validate our 30 minute rule.

 

Validation Design
60 red cell units will have their temperature monitored for 40 minutes after their release from the Blood Bank. Units released from the Blood Bank will be taken to defined locations where they will be placed near the floor's receptionist. Prior to the lapse of 30 minutes, the products will be returned to the Blood Bank. Temperature monitoring will continue for an additional 10 minutes before the temperature monitor will be stopped.
 
TempTale Preparation
-Set TempTale to monitor 1-100C for 2 days.
 
Unit Preparation
-A unit of blood will be split into 2 equal parts.
-The 2 parts of the unit of blood will be rubber banded together with an activated TempTale placed in the middle. Minimize as much air between both halves of the unit as possible.
-Place unit in a monitored refrigerator in Coordinating for at least 24 hours.
-Record date and time unit is placed into refrigerator on form created for this validation.
 
Monitoring
-After 24 hours, unit prepared for this validation can be used for temperature monitoring.
-Prepare a timer for 30 minutes.
-The release of the unit must coincide with the release of an actual blood product to be transfused on the floors - this will be used to reflect the time it takes to issue a product. Unit must be placed in a white plastic bag used for transport of blood products.
-Document the day and time of issued on the form created for this validation. Start timer and proceed to one of the locations defined by this validation.
-Once at the defined location, place the bag with the unit near the receptionist's station. Remember to leave this location in enough time to be back in the Blood Bank by 30 minutes from release of the product. Record the time the 30 minute timer goes off.
-Once back at the Blood Bank, place the bag on the counter and wait an additional 10 minutes until stopping the TempTale.
-Record the time you stop the TempTale on the validation form.
-Download TempTale data. Enter time of issue, 30 min, and 40 min intervals on TempTale temperature graph. Prepare unit for next observation.
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For those who responded that they use temperature as the criteria for return to inventory, how are you taking the temperature?  We use Safe-T-Vues to monitor temperature but it sounds like some of you are taking actual temps.

 

Temp-Check Model TC-3 Hampshire Controls

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Although our SOP follows the 30 minute rule most of us choose to physically put the unit back into refrigeration and tell the transfusing RN that he/she has only what is left of the total 4 hours to infuse the unit. The unit is "quarantined" and can be used only for that patient it was initially issued to. It is discarded otherwise. We do not take back any spiked units.

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  1. Best practice would be to take the temperature on returned units rather than use the 30 minute rule (just a thought)
  2. What we have told Nurses every place I have worked (from 200 bed Hospitals to 1,200 bed Hospital) is.....if you can transfuse the unit within 4 hours from the time we released it, just keep it on the floor (not in any unmonitored refrigerator) and transfuse when you resolve the problem.  If you cannot, then return the unit if it was never spiked and/or none of the product was given (so it does not appear in our computer system that patient was transfused); or discard the remainder of the unit if part of it was transfused.
  3. We use TEMPCHECK, but could also fold your unit around a thermometer; or use a digital thermometer.

Brenda Hutson

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We use a infrared thermometer that was validated using a digital thermometer with a probe.  For OR we use HemoTemp II indicators so they don't leave units out of the refrigerator for the surgery then decide to place them back into the OR blood bank refrigerator before returning the unit to us.  I got cited a couple years ago by the AABB for having the 30 minute rule in my procedure (I was in the process of validating the infrared thermometer at the time the inspection occurred).

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Ditto what Dr. Pepper said: we use temp not time.  We also find RBC units to exceed 10C in 10-15 minutes.  We measure the temp on return.  If over 10C we notify the RN that the unit can be reissued for transfusion to that patient only if transfusion can be completed within 4 hours of the origianl dispense time.  We document the required time for completion on the transfusion record with the following:

 

Reissued Unit. Transfusion must stop at:

Date_______________ Time_______

RN notified:_____________               by:

 

Like your sticker. I think I'll steal the idea.

 

Cliff, I like your validation procedure.

 

What we do to check the temp is wrap the unit around a digital thermometer probe.

Edited by AMcCord
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We use Safe-T-Vues for units sent in coolers to the OR or off-site but don't want the expense of using them on every unit sent to the floors, few of which are returned. We bought an infrared thermometer that also has a digital probe but could never get the infrared reader to give consistent readings. So we just wrap the returned unit around the probe.

An AABB question (standard 5.26): "Blood ... shall be accepted into inventory for reissue only if ... The appropriate temperature has been maintained." I had been told a bit ago by AABB we could not reissue a too-warmed returned unit even if it was going back up to be infused within the 4 hour window. I like the sticker idea, too, but seems to be in violation of this. Has the AABB changed its tune, that a brief return (for the sticker!) and reissue is not "accepting into inventory"?

Thanks - Phil

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  • 4 weeks later...

I tested this rule with 2 units on a nursing floor with a global sensor recording one minute readings for 40 minutes.

The test was conducted in a nursing area comprable to the patient rooms. The 2 units were stored on the counter with a global sensor wire between the units.

 

The unit raised in temperature around 19 minutes for 1-10C. So our hospital has changed to the 15 minute rule that the nursing programs are teaching currently.

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We use Safe-T-Vues for units sent in coolers to the OR or off-site but don't want the expense of using them on every unit sent to the floors, few of which are returned. We bought an infrared thermometer that also has a digital probe but could never get the infrared reader to give consistent readings. So we just wrap the returned unit around the probe.

An AABB question (standard 5.26): "Blood ... shall be accepted into inventory for reissue only if ... The appropriate temperature has been maintained." I had been told a bit ago by AABB we could not reissue a too-warmed returned unit even if it was going back up to be infused within the 4 hour window. I like the sticker idea, too, but seems to be in violation of this. Has the AABB changed its tune, that a brief return (for the sticker!) and reissue is not "accepting into inventory"?

Thanks - Phil

 

In the old accreditation manual it was acceptable to re-release a unit for the same pt as long as the infusion was completed within 4 hrs of the original release.  There is no valid reason why this cannot happen.  Some assessors can's see the forest for the trees. 

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  • 3 weeks later...

From Transfusion

Is the 30-minute rule still applicable in the 21st century?
  1. Donny Dumani MD, MS,
  2. Dennis Goldfinger MD and
  3. Alyssa Ziman MD

Article first published online: 10 JUN 2013

DOI: 10.1111/trf.12220

© 2013 American Association of Blood Banks

Issue

cover.gif?v=1&s=94ac7c086ae93c8263b72713
Transfusion

Volume 53, Issue 6, pages 1150–1152, June 2013

 

 

 

This is a little long for a forum but...

 

Many blood bankers have questioned the validity of the 30-minute rule for reissuing blood, and the possibility of lengthening the exposure period for red blood cell (RBC) units to be out of refrigerated temperature storage and subsequently returned to inventory. The current hesitation is that extending this rule could compromise the quality and safety of the units. In the current issue of TRANSFUSION, Thomas and colleagues[1] take a fresh look at the impact of RBC quality after repeated exposures up to 60 minutes. This study provides a strong case to finally acknowledge that the 30-minute rule is outdated, allowing consideration to a 60-minute cutoff with no impact on RBC quality.

 

To address this issue, we must understand the origins of the 30-minute rule. It gained notoriety following a publication by Pick and Fabijanic[2] in 1971, who incorporated findings from two earlier studies that illustrated the importance of maintaining “optimal” storage temperatures to prevent deleterious effects to RBCs.[3, 4] In the Pick study, temperature changes of whole blood units stored in ACD preservative solution were monitored at 15-minute intervals. It was shown with subsequent incubation at room temperature that both the surface and the core temperatures of these units exceeded 10°C after approximately 30 and 60 minutes, respectively. Based on these findings, Pick and Fabijanic concluded that to maintain RBC viability (as defined by Hughes-Jones[3] and Matthes et al.[4]) at room temperature, a period not to exceed 30 minutes outside 4°C −10°C was necessary. However, the study did not report any outcome results regarding the quality of RBCs, nor did it provide any data regarding bacterial proliferation. Additionally, the whole blood units studied are not equivalent to present-day RBC products, given current collection and storage practices (i.e., using RBC concentrates with CPDA or CPD with additive solution [AS]).

A review by Brunskill and coworkers[5] further highlighted significant discrepancies in these published studies. As stated above, Hughes-Jones[3] used 10- to 15-mL aliquots of RBCs stored in ACD at temperatures up to 10°C for 34 days and demonstrated that the viability of RBCs diminished significantly when stored at 10°C for these extended periods of time. Brunskill and colleagues argued that exposure of such small volumes to temperature changes cannot be considered equivalent to the larger transfusion-sized RBC units, as it is well known that smaller samples warm more quickly. In addition, using different anticoagulants, such as ACD versus CPDA, is also known to influence adenosine triphosphate (ATP) maintenance, and hence the viability of the RBCs during longer storage periods. These same authors also identified five studies[6-10] from 1987 to 2010 that reported on the outcome of blood products exposed to various temperatures in relation to the 30-minute rule. Of those five studies, only two reported data on variables of RBC quality, which included the rate of hemolysis (n = 2), ATP concentration (n = 2), and/or in vivo RBC recovery (n = 1).[6, 7] They argued that although these two studies utilized current collection practices (RBCs with CPD with AS), the conclusions that could be drawn from these publications were limited due to small or undefined sample volumes. The remaining three studies[8-10] illustrated data involving the rate of warming, but without reporting any effect on RBC quality or bacterial proliferation.

In comparison to the previously published studies, Thomas and associates[1] conducted an extensive study to resolve these limitations and investigate whether the in vitro quality of RBCs is adversely affected by 30- and/or 60-minute exposures to extreme ambient temperatures of 30°C. The study design included ABO/D-matched, leukoreduced RBCs stored in CPD and SAGM preservative solution that were pooled into a transfer bag and then split into adult-sized (300 mL) or pediatric-sized (65 mL) units. Units were exposed to various temperature fluctuations to mimic the transport, issue, and return processes and the duration of a transfusion episode. In vitro assessments included hemolysis, supernatant potassium levels, and ATP and glucose levels. Their findings indicate that these variables were stable following a pattern typical of a unit with no exposures, despite multiple temperature deviations up to 30°C. Furthermore, these variables did not show any significant differences for in vitro assessment of potassium and glucose and were within acceptable limits for hemolysis and ATP up to Storage Day 35 specifically for units with three or fewer 60-minute exposures. These findings demonstrate that the 30-minute rule is unnecessarily restrictive even under the extreme conditions reported by the authors and provide the catalyst to move forward with a new rule, which still provides a safe and viable RBC component for transfusion.

Finally, the authors[1] comment that additional studies may be required to investigate temperature fluctuations on bacterial growth. We would argue that these studies are not necessary. First, several published reports[11-13] showed no difference in bacterial growth between Gram-negative and/or Gram-positive bacterially inoculated RBC units exposed to room temperature for at least 2 hours versus those that remained in refrigerated storage. Second, the effect of temperature relative to the type of bacterial contaminant must be considered. The most common contaminants, which are Gram-positive skin flora, do not survive in refrigerated blood, and therefore most units containing these bacteria have a tendency to self-sterilize.[14-16] While Gram-negative contaminants, psychrophilic bacteria (such as Yersinia enterocolitica, Pseudomonas sp., and Serratia liquefaciens) can escape this bactericidal action under refrigerated storage conditions, it has been reported that such bacteria do not undergo accelerated proliferation or reach clinically significant levels after at least 2 hours of room temperature exposure.[11, 12, 15, 17] This aspect of psychrophilic organisms was recently validated by Ramirez-Arcos and colleagues[13] who demonstrated no difference in growth or endotoxin production between psychrophilic-contaminated RBC units exposed to room temperature multiple times for 30- versus 60-minute periods. Finally, the current risk of transfusion-transmitted sepsis secondary to bacteria in RBC units is extremely low. In the most recent report by the Food and Drug Administration, there were no cases of transfusion fatalities secondary to bacterially contaminated RBC units between 2007 and 2011.[18] The decreasing trend of bacterial contamination could be partly explained by the adoption of several strategies to prevent such a catastrophic event including improved blood donor screening, donor skin preparation and disinfection, initial aliquot diversion, and leukoreduction. Based on the aforementioned studies and statistics, extending the rule to 60 minutes would not increase the incidence of bacterially contaminated RBC units in inventory.

In conclusion, the 30-minute rule is based on old observations that are no longer valid in today's practice. For the past 20 years, many have attempted to address this issue without much resounding success, but several experts have recognized that the rule is weak and unnecessarily burdensome. Thomas and coworkers[1] present compelling data showing no detriment to increasing this time period and therefore provide a strong argument to change the rule without compromising the viability of the RBCs. Blood bankers are obligated to ensure not only the quality and safety of blood units, especially when considering a significant change in our guidelines of reissuance, but are also charged with the responsibility of conserving a scarce resource. Unnecessary wastage should not occur based on an obsolete rule that is not relevant to current practice. With the growing concerns of costs involved in acquiring and maintaining a safe and sufficient RBC inventory, adopting the 60-minute rule is simply the right decision for the 21st century.

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I read this study. Keep in mind that there are many facilities across the country, particularly large ones, that want to do this because they cannot control their internal processes associated with storage and handling of blood components. This is a single study that admits that potentially bacterial proliferation needs to be studied.

How would you implement this and totally disregard the temperature of units returned unused by Nursing?

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I would let one of these large centers perform the studies that would show that units left out for "X" minutes that attained a temperature of "X" were safe for transfusion by 'these criteria'. Then I would cite their study in my p&p.

It would have to be better than the 10 minutes or so that it takes a unit of blood to reach >10c as measured by my infared thermometer. What a waste that is. How many years did how many hospitals use the 30 min rule and how many adverse outcomes were there due to this practice? Impossible to answer the last question but I would suggest, very few.

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We do not accept returns unless the order has been cancelled by the physician or the patient has expired. Nursing policy is to keep the unit up there and transfuse it within 4 hours from issue time.

If the unit does come back for one of the 2 reasons above, we take the temp. If 10 or below, we accept it back into inventory. If above 10 it is discarded. We use return temp, not time frame. From what I understand you can use a time frame, but you have to do a validation to see what the acceptable time frame is for your facility. 30 minutes would absolutely be out of temperature range.

In the USA, 350 bed hospital.

Ditto except the FDA forced us change the criteria to 1-6oC because the unit is considerd 'stored' not 'transported' once it has stopped moving from one place to another.  (Someday they will fix this unsubstantiated dual temperature requirement.)

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