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Validation Boxes for the transport of blood components


mpmiola

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Dear's,
I work in a Transfusional Agency that serves several Hospitals. In the hospital we are installed, we carry the transfusion bags in boxes validated for transportation without refrigerant. We have established a time of up to 30 minutes for delivery (from the Agency to the patient).
 However, an auditor asked to transport in boxes with temperatures between 1 and 10ºC. I can not agree with this, although it is in a tropical region, with temperatures up to 35ºC, our hospital has refrigeration with temperatures between 18 and 24ºC. I believe we are correct, but I need to know how this transport happens in other services.

Appreciate your help.

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I am in the US, so I am only familiar with our rules.  I agree with your auditor.  I know there is no "30 minute rule", but we were able to validate it it (extensively) in our hospital.  We are a closed temperature controlled environment and would clearly never see temps nearing 35 inside our hospital.  I'd suggest you transport these in validated coolers with wet ice or reusable ice blocks.

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3 hours ago, Cliff said:

Estou nos EUA, por isso estou apenas familiarizado com as nossas regras. Concordo com seu auditor. Sei que não há "30 minutos regra", mas Pudemos validá-lo (extensivamente) em nosso hospital. Somos um ambiente fechado temperatura controlada e claramente nunca ver temperaturas aproximando 35 dentro do nosso hospital. Eu sugiro que você transporte estes em refrigeradores validados com gelo molhado ou blocos de gelo reutilizáveis.

Thanks for answering Cliff!
Our hospital is also closed and temperature controlled (18-24). Our legislation allows for 30 minutes. However, I think if it is not transported on ice, the pouch can be transfused as soon as it is delivered. Otherwise, the nursing will wait 30 minutes. So it seems the same to me ... can you understand me? What do you think now?

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I can see your point @mpmiola, if the box is validated to keep the blood product at the appropriate temperature for thirty minutes, it stands to reason that it should be acceptable to use for transport to patient care area for immediate transfusion, or during a brief pause (up to 30 min) at the patient's bedside while the nurses prepare for the transfusion.

On the other hand, what mechanism prevents this box from being used to store blood at the patient's bedside for longer than 30 minutes?

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18 hours ago, mpmiola said:

Thanks for answering Cliff!
Our hospital is also closed and temperature controlled (18-24). Our legislation allows for 30 minutes. However, I think if it is not transported on ice, the pouch can be transfused as soon as it is delivered. Otherwise, the nursing will wait 30 minutes. So it seems the same to me ... can you understand me? What do you think now?

Are you saying that your nurses want to wait until the unit is "warm" (RT)??  Is that why they would wait another 30 mins if they received the unit in 1-10C packaging?

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6 hours ago, goodchild said:

Eu posso ver seu ponto @mpmiola , se a caixa é validada para manter o produto de sangue na temperatura adequada durante trinta minutos, é lógico que ele deve ser aceitável a utilização para o transporte para a área assistência ao paciente para transfusão imediata, ou durante uma Breve pausa (até 30 min) na cabeceira do paciente enquanto os enfermeiros se preparam para a transfusão.

Por outro lado, que mecanismo impede que esta caixa seja usada para armazenar sangue na cabeceira do paciente por mais de 30 minutos?

The same nurse who transports, performs the transfusion. We have records of exit and start of the transfusion.

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5 horas atrás, cswickard disse:

Você está dizendo que suas enfermeiras querem esperar até que uma unidade de "quente" (RT) ?? É por isso que eles estão esperando mais de 30 minutos para receber uma unidade em 1-10C embalagem?

Yes, expect room temperature! Not necessarily the 30 minutes. 

This is the point! If we follow the guidance of the auditor and carry out the transport Cold (1-10), we will have to wait a little. Why not consider the transport time in RT?

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I agree with Ciff and the Auditor that the best way is to transport it with cold material. This is how we do with external institutions to our Hemotherapy service. However, our inpatients are prepared for transfusion prior to delivery of the bags. When the nurse arrives with the bag, it usually does not take more than 5 minutes to install. So I have doubt if it really is necessary. Thank you for your contribution. Despite the difficulties we have ... we want to provide the best to our patients. I apologize for my poor English.

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Our nurses hang the blood in-house at whatever temp it is by the time they make it back to the floor - cold or warming slightly.  They must hang the unit within 30 mins of issue and transfuse within 4 hours of the unit's issue time (all recorded on our Transfusion tags).  We only transport in 1-6C packaging if going to our outpatient oncology unit (across the parking lot) and/or if more than one unit is going out at a time.  The units left waiting for transfusion (when we have issued more than one unit) are kept cold in the transport container (check the Pelican Biothermal Credo line of Products - especially the Series 4 O.R. Igloo container, 2 liters) and would be acceptable back into inventory because they have been kept at the correct temps.  If you only ever issue one unit at a time, the RT transport should be OK, as long as the unit is given within 4 hours, but it would not be acceptable back into inventory.   Anything leaving the building definitely needs controlled temperature transport.  Does this help?

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