Evaluating the 4‐hour and 30‐minute rules: effects of room temperature exposure on red blood cell quality and bacterial growth

Ramirez‐Arcos, Sandra; Mastronardi, Cherie; Perkins, Heather; Kou, Yuntong; Turner, Tracey R.; Mastronardi, Emily; Hansen, Arild E.; Yi, Qilong; McLaughlin, Natasha; Kahwash, Eiad; Lin, Yulia; Acker, Jason P.

doi:10.1111/j.1537-2995.2012.03807.x

Cited by 37 publications

(47 citation statements)

References 16 publications

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“…Although psychrophilic bacteria are able to grow in RBCs, here we show that for the chosen species, growth is not significantly different in RBC units exposed for 30 or 60 min to RT. This study confirms previous findings showing that there is no additional risk to RBC safety by increasing RT exposures from 30 to 60 min [4,6,12]. It should be noted that for S. marcescens there was a significant increase in bacterial growth between the control (non-exposed) units and units exposed to RT for either 30 or 60 min.…”

Section: Discussionsupporting

confidence: 80%

“…An extension of the 30-min rule beyond 60 min is not recommended as we have previously shown that pathogenic bacteria start growing in RBCs after 2 h of RT exposure [12]. Hence, multiple exposures for periods longer than 60 min would likely increase the risk of having high bacterial titers early during RBC storage.…”

Section: Discussionmentioning

confidence: 99%

“…Hence, multiple exposures for periods longer than 60 min would likely increase the risk of having high bacterial titers early during RBC storage. The previous study also challenged the 4-hour rule for transfusion, demonstrating significant bacterial growth during a single 5-hour RT exposure of RBCs [12]. For that reason, clinicians should be cautious of this safety risk and have a strict time limit for the transfusion process.…”

Section: Discussionmentioning

confidence: 99%

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Changing the 30-min Rule in Canada: The Effect of Room Temperature on Bacterial Growth in Red Blood Cells

Ramirez‐Arcos

Kou

Ducas

et al. 2016

Transfus Med Hemother

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Background: To maintain product quality and safety, the ‘30-min rule' requires the discard of red blood cells (RBCs) that are exposed to uncontrolled temperatures for more than 30 min. Recent studies suggest this rule may safely be extended to a 60-min rule. Methods: A pool-and-split design study (N = 4) was run in parallel at Canadian Blood Services (SAGM RBCs) and Héma-Québec (AS-3 RBCs). RBCs were spiked with ∼1 colony-forming unit/ml of mesophilic and psychrophilic bacteria. Control units remained in storage at 1-6 °C for 42 days. Test 30 (T30) and T60 units were exposed to room temperature (RT) six times during storage, each time for 30 and 60 min, respectively. Bacterial proliferation was monitored. Results: Mesophilic bacteria do not proliferate in RBCs. The growth of psychrophilic bacteria is not significantly different in RBCs exposed for 30 or 60 min to RT (p < 0.05). Conclusion: The study findings were the final evidence to support extension from a 30-min rule to a 60-min rule in Canada.

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Changing the 30-min Rule in Canada: The Effect of Room Temperature on Bacterial Growth in Red Blood Cells

Ramirez‐Arcos

Kou

Ducas

et al. 2016

Transfus Med Hemother

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“…11 Recently, a number of studies have examined the impact of various scenarios of RBC concentrate exposures to temperatures ranging from 10°C to 30°C on RBC concentrate quality and bacterial growth. [12][13][14][15][16][17] As a result, some authors have been advocating that the duration of RBC concentrates to be allowed out of controlled temperature storage and still be eligible for return to storage for reissue should be extended from 30 to 60 minutes. 14,17,18 This would certainly lead to a reduction of RBC concentrate discard.…”

Section: Discussionmentioning

confidence: 98%

Temperature-Sensitive Indicators for Monitoring RBC Concentrates Out of Controlled Temperature Storage

et al. 2015

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“…6,7 One study did show that growth of Gram-negative Serratia species was enhanced slightly after RBC units were contaminated and incubated at room temperature compared with contaminated units at storage temperatures. 8 While the numbers of colony-forming units (CFUs) increased compared with storage temperature controls for both experiments, the number of CFUs did not reach clinically significant levels. Studies to date have not conclusively shown evidence of a decline in physiologic quality or increased risk of clinical bacterial sepsis from blood products exceeding defined temperature ranges, and additional well-designed studies are needed.…”

Section: Discussionmentioning

confidence: 99%

Transportation Cooler Interventions Reduce Plasma and RBC Product Wastage

Metcalf¹,

Baker²,

Goodnough

et al. 2016

Am J Clin Pathol

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Objectives: The rate of plasma product wastage for the United States in 2011 was approximately 1.8%. The plasma wastage rate at our institution was higher, mainly due to products returned out of temperature range from procedural areas. A process review and intervention to reduce plasma wastage was undertaken, which included modifications to our transport cooler.Methods: A new cooler system was designed, and this device was implemented alongside an updated protocol for delivering plasma while also enhancing the previous RBC cooler validation time. We audited plasma and RBC product wastage prior to these interventions, from January 2013 to February 2014, vs after the intervention from April 2014 to March 2015.Results: After the intervention, the monthly plasma wastage rate declined 60% (12.6 units/100 units transfused preintervention vs 5.0 units/100 units transfused postintervention; P < .0001). The monthly RBC wastage rate also decreased 28% (3.2 units/100 units transfused preintervention vs 2.3 units/100 units transfused postintervention; P < .01).Conclusions: Our intervention resulted in significantly decreased plasma and RBC wastage and is broadly applicable, since out-of-temperature product wastage in procedural areas is likely a significant problem at many institutions.The most recent data collected by the US Department of Health and Human Services in 2011 indicate that the percentage of plasma product wasted nationally was 1.8%. Data were not published for RBC unit wastage, but prior studies suggest RBC wastage rates may be similar but variable.2 A significant challenge in wastage is that products go out of temperature (OOT) when they are held in procedural areas to help meet the clinical need of instant blood access. Through our quarterly Transfusion Service Committee meetings, we became aware that product wastage at Stanford Healthcare (SHC) was noticeably higher than the national average. The primary driver of the increased wastage was products returned OOT from operating rooms (OOT for transport coolers: >10 C). While SHC has employed a number of strategies to provide blood emergently to procedural areas, including emergency blood order sets, close physical proximity, and a dedicated pneumatic tube system channel, there is added comfort for operating room (OR) personnel to have instant access within a room to cross-matched blood products for elective, complex surgical cases.Here we review our experience and results from process improvement initiatives to lengthen cooler validation time intervals for blood products, reduce repacking during surgical cases, validate cooler temperature range within the stricter 1 C to 6 C range instead of 1 C to 10 C, and overcome challenges with chemical temperature-sensitive adherent monitors.

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Evaluating the 4‐hour and 30‐minute rules: effects of room temperature exposure on red blood cell quality and bacterial growth

Abstract: Single or multiple RT exposures did not affect RBC quality but slightly promoted bacterial growth in contaminated units. The clinical significance of these results remains unclear and needs further investigation.

Cited by 37 publications

References 16 publications

Changing the 30-min Rule in Canada: The Effect of Room Temperature on Bacterial Growth in Red Blood Cells

Changing the 30-min Rule in Canada: The Effect of Room Temperature on Bacterial Growth in Red Blood Cells

Temperature-Sensitive Indicators for Monitoring RBC Concentrates Out of Controlled Temperature Storage

Transportation Cooler Interventions Reduce Plasma and RBC Product Wastage

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