Category Archives: Blood Storage

France’s national blood transfusion service, the Établissement Français de Sang (EFS) – interview with Dr Jean-Pierre Zappitelli

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Dr Jean-Pierre Zappitelli is a pharmacologist and biologist, who works as the senior manager of the Aix-en-Provence laboratory of France’s national blood transfusion service, the Établissement Français de Sang (EFS). He discusses his work within the context of managing the cold chain for blood products

How does the EFS laboratory in Aix-en-Provence fit in with the rest of the EFS and how would you describe your work?

The EFS is France’s sole operator of blood transfusions and its work covers the processing of donations of blood, plasma and platelets. The EFS is France’s safety guarantor of the blood transfusion chain, from donor to recipient. It supports the care of over 1 million patients per annum across France and its overseas territories via 132 fixed and some 40,000 mobile donation sites.

pic-1-esf-laboratories-in-alpes-mediterrarnee-regionThe EFS laboratory in Aix-en-Provence is a reception and distribution point of blood products that have been tested post-donation for pathogens and are ready to be used. In 2015, it processed 20,148 units of blood products (17,529 units of red blood cells; 1,148 units of platelets and 1,471 units of plasma) for the care of 3,759 patients.

I’m the Aix-en-Provence laboratory’s senior manager responsible for delivery and distribution of blood products. By “delivery”, we mean blood products for specific named patients, while by “distribution” we mean for unnamed patients, for instance for hospital stock top-ups.

My work involves ensuring firstly that all of the products we receive are safe to use; secondly that while these products are in the laboratory’s care, they are stored correctly; and lastly, that they are correctly labelled and packed when they leave the laboratory.

How does the Aix-en-Provence laboratory manage the cold chain for the blood products in its care?

This is achieved by maintaining and monitoring the temperature in various areas in the laboratory.

Firstly, the ambient temperature in the laboratory itself is maintained at 25°C. We do this because this is the recommended temperature for the products that are used to determine blood type. If for some reason, this temperature level of 25°C is breached, an alarm sounds and dealing with this issue becomes the primary task that is attended to.

pic-2-refrigerator-temperature-monitorSecondly, all units of blood products – platelets, red blood cells and plasma – are all kept in their own designated refrigerators. These all have a temperature indicator on their door, as well as an independent temperature monitor that is linked to an online map of all of the refrigerators in the laboratory, that is updated in real time with a full suite of data analytics.

The laboratory’s refrigerators have a safety feature whereby whenever one is opened and then closed, a magnet is activated and it cannot be opened for one minute in order to restore the correct ambient temperature within it.

Thirdly, all units of blood products come to the laboratory from regional stock in their own type of container with a “thermo-button” temperature data logger that has monitored the ambient temperature within every container we receive. These temperature data logger are checked using a sensor linked to a PC to ensure that the cold chain wasn’t broken prior to reception. (Some other laboratories in the region use RFID data loggers and for these, the crates don’t need to be opened for data monitoring downloads.)

pic-3-thermo-button-temperature-data-logger-and-sensorAlso, all the bags of products in a group of bags are attached together with a self-locking cable tie that can only be removed by cutting it with pliers.

For blood products that leave our laboratory or may be returned, we group these units of blood products with both a self-locking cable tie and a thermo-button temperature data logger.

Lastly, every group of blood product bags is labelled with a tag indicating source, destination, required temperature and a security notice around handling. Also, every bag of blood product has its own barcode allowing for full traceability.

The laboratory also needs to consider how deliveries of bags of blood products are managed and for this we use two systems: either refrigerated vehicles or isothermal padding.

For bags of red blood cells and platelets, plastic crates are used for transportation in refrigerated vehicles. The crates contain the appropriate type of ice-pack to ensure optimal temperature levels within the crates. Also, these let in the cooled refrigerated air within the vehicle to further ensure that the correct temperature is maintained within them.

For deliveries of bags of frozen plasma, air-tight isothermal crates with extra isothermal padding and its appropriate type of ice-pack. Also, all units of frozen plasma are protected with bubble wrap to avoid any breakages during transportation.

Lastly, all crates are labelled with information regarding source, destination, required temperature and a security notice around handling. Naturally, only authorised personnel can open a crate and this too is indicated on every crate.

How does the laboratory manage suspect items?

The main rule we work by is to eliminate all doubt around decision making about a product. Either it is objectively safe to use or it isn’t, and both of these scenarios are backed up by data, or a lack thereof.

pic-4-thermo-button-temperature-data-logger-readout-within-2c-and-6c-rangeUntil we can determine that a suspect unit of product is safe to use, it’s placed in a quarantine refrigerator until its safety has been 100% confirmed. If this can be done, it then is moved to the appropriate refrigerator. If this cannot be done, it’s disposed of by means of incineration.

Also, any such suspect product, which goes on to be disposed of, is fully documented to ensure full traceability.

In the lab, we make sure that the technicians who process the products we process are never in any doubt about what course of action they need to take.

Our safety systems are built to enable any of our processes to stop at any point. There’s simply no room for error. Patients’ lives are at stake.

What are the risks if the cold chain is broken (plus or minus)?

The risks associated with managing the cold chain for blood products underpins all our work.

If the cold chain for a bag of red blood cells is broken, say during transport, and its core temperature rises above 10°C, the risk is that the patient receives a transfusion that is infected by potentially harmful bacteria. And even with minute amounts of bacteria, at temperatures above 10°C bacterial reproduction can be considerable. For a healthy person, this needn’t necessarily be a problem, but for an already weakened sick patient, it can be extremely dangerous. And for temperatures below 2°C, the risk here is that ice crystals will form, thus impairing its oxygenation property.

Similarly, if platelets are stored or transported at temperatures below the specified limit, there is also an inefficiency risk. So if for example these are stored or transported at a temperature of 12°C instead of 24°C, the purpose of the transfusion (to replace platelets further to some chemotherapy therapy) will be adversely affected, which again poses a danger to the patient. And just like red blood cells stored or transported at a temperature above 24°C, the risk is bacterial reproduction is very high.

pic-5-bag-of-frozen-plasma-1For plasma, the risk when the cold chain is breached is that the product will be altered very rapidly. Plasma is an extremely fragile product that must be used within six hours of being unfrozen.

The final risk around managing the cold chain for blood products is around the labelling of each item. This is why we use various identification tools, including unique barcodes on every bag of blood product. During transport for instance, correct labelling ensures the timely and correct delivery of blood products.

When this doesn’t happen, stocks of blood products could be either delivered to the wrong destination, or arrive late, leading to patients not benefiting from them when they need them or a hospital’s stocks running low, or worse running out, which again puts patients at risk. Furthermore, incorrect labelling inevitably leads to unnecessary wastage to eliminate any chance of putting a patient at risk with a potentially unsound product.

Managing these risks is why for every unit of blood product, there has to be absolute certainty regarding where it’s come from and what its destination is. There’s no room for any grey areas in our work. We only work with 100% certainty around the safety protocols for the blood products we process.

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Timestrip to demonstrate Blood Temperature Indicator at the AABB Expo

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If you are attending the Annual Meeting of the AABB – the CTTXPO in Denver, Colorado, starting Monday October 14th, we look forward to seeing you. We’ll be on booth 1654 with our partners Shockwatch, demonstrating our latest product innovation – the Blood Temp 10 indicator label.

We also have a speaker slot at the show, starting at 1.30pm on Monday 14th, where we will be presenting a  case study highlighting how temperature indicators not only help identify potentially heat damaged blood but also assist with identifying critical control points within your blood reissue compliance cycle (BRCC).

Timestrip Blood Temp 10

A study published by the American Journal of Clinical Pathology found that temperature sensitive labels for monitoring blood can help hospitals and blood banks conform to the American Association of Blood Banks and US Food and Drug Administration standards for safe human blood transportation and storage.

While many front-line teams rely on the “30 minute rule” for returning blood back into storage, using a temperature sensitive label ( blood temperature indicator ) can increase the safety of the blood life cycle, while reducing wastage.

They found:

“…these devices offer transfusion services an opportunity to develop and validate their own in-house procedures to supplement and, thereby, improve on decisions using the 30-minute rule. For example, if a unit of RBCs were overheated by placement on a hot surface (eg, microwave heater, radiator, or the top of a refrigerator) but returned within 30 minutes to the transfusion service, its potential unsuitability would not be identified by a transfusion service relying only on the 30-minute rule. However, such a potentially unsuitable unit would be likely to be recognized if a temperature-sensitive label had been in place. 

Also, procedures can be developed to use temperature-sensitive labels to avoid unnecessary and costly discards of blood components when storage for more than 30 minutes outside a temperature-monitored refrigerator raises questions about suitability.”

The adoption of our simple to use technology as a vital element of the BRCC compliant process will help deliver new levels of accountability across the RBC temperature management teams.  Front line teams know the value of clear, simple communication. Add in the fail-safe component of the Blood Temp 10 and the simplicity of use (including no additional pre-conditioning or expensive associated consumables) and they can see the real value of our technology.

In support of our latest technology we’re also presenting a paper on best practices for keep your blood supply safe in our Learning Lab, entitled “Before Good Blood Goes Bad.”

According to the WHO around 107 million blood donations are collected globally every year and it is generally accepted that 2% of blood may be discarded.  The use of suitable equipment and good management of blood cold chain are important means of minimizing losses and donated blood.

Visitors to our booth will be able to see the extent of savings achievable through the adoption of the Blood Temp 10 indicator label with our interactive Cost Calculator.

We invite you to join us and the ShockWatch team in Colorado next month and look forward to meeting members of the AABB.

Released by Timestrip 30/09/2013 http://www.timestrip.com/

blood temperature indicator

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Blood Temp 10 at the AABB annual meeting & CTTXPO in Denver, Colorado

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Come see the Shockwatch Blood Temp 10 in action at the AABB annual meeting and CTTXPO in Denver, Colorado Monday, Oct. 14th, 1:30 pm booth 1654.  You can also hear about best practices keep your blood supply safe in our Learning Lab “Before Good Blood Goes Bad.”

Presentation overview:Timestrip Blood Temp 10

Heating, freezing and thawing all affect the viability of blood and blood products and components. Temperature monitoring is a vital step in maintaining the safety of the world’s blood supply, ensuring that blood already known to be safe, remains safe.

A case study will be shared during the presentation to show how temperature indicators not only help identify potentially heat damaged blood but also assist with identifying critical control points within your blood logistics cycle.

According to the WHO around 107 million blood donations are collected globally every year and it is generally accepted that 2% of blood may be discarded.  The use of suitable equipment and good management of blood cold chain are important means of minimizing losses and donated blood.

A lack of product data leads to an unpredictable blood cold chain, which will create an environment of guesswork, assumptions and inaccurate predictions when it comes time to make blood safety and cost-recovery related decisions.

The lack of accurate data due to a poorly designed temperature tracking system will force the disposal of unadulterated blood and create financial loss.  These results are very expensive consequences that can be overcome with the implementation of the Blood Temp 10.  Developing a system of bag level temperature monitoring will deliver the results required to effectively build and maintain predictable cold chain management, allow for a greater level of cost recovery and drive awareness throughout the blood cold chain.

Bacterial contamination of blood components is the most frequently reported cause of transfusion-related fatalities.  BT10 ensures that bacteria growth due to elevated temperatures has not compromised blood during storage, transportation and distribution     

Increase patient safety by confirming blood product is kept within the required conditions.  If unsafe temperature conditions occur the BT10 will give you an assurance to know that you’ve captured those issues prior to introducing unsafe blood to a patient.

Mainlining temperature control during storage and shipment is of extreme importance in order to uphold high standards of regulatory compliance.  There are many variables that will negatively affect the safety of your blood supply.  Blood Temp 10 will provide auditable proof that each individual blood bag has been maintained according to relevant regulations.

We invite you to learn more – leave us your contact information and we will schedule a time for you to come visit the booth for a live demonstration.

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Helapet BloodPorter for Blood Transport

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Helapet BloodPorter carrying systems are designed for the safe and controlled transportation of red blood cells, platelets and plasma between hospital sites blood banks and wards. Featuring a replaceable inner moulding surrounded by a robust carrying bag, the BloodPorter can effectively maintain the desired temperature threshold for extended periods of time whatever the external conditions.

Ideal for keeping blood products warm or cool, the BloodPorter carrying system is available in a selection of sizes and configurations to suite specific applications. A custom design service is also available for specific colour and artwork requirements*

MediCool technology

BloodPorter carrying systems use MediCool packs which can be repeatedly used to maintain the internal storage temperature. Comprised of a water based non-toxic solution, Medi

Group Blood Porter Shot

Cool packs can be configured in each porter, eliminating the need for ice and improving storage capacity. The BloodPorter can be used with dry ice, and protective polythene liners are available to extend the life of the product.

Safety and security

With strong carrying straps for safe lifting and handling and a secure velcro fastening system, the Helapet BloodPorter enables quick access whilst providing extra protection for the inner chamber. When security is an issue, a tamper evident closure system is available. Each porter also comes with a clear document holder allowing the insertion of instructions/information making identification simple and easy to use.

Replacement inners to save money
Each BloodPorter utilises a fully replaceable polystyrene inner moulding to store and protect transported blood samples. Tailored to the size of each BloodPorter , customers can order replacement inner mouldings and polythene liners from Helapet to maintain the chamber integrity

Keep updated on Helapet Cold Chain Management developments on www.helapet.co.uk, or visiting our Facebook and Twitter pages

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Temperature-Sensitive Labels for Containers of RBCs

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I found an interesting article that compares three types of temperature sensitive label and a digital thermometer for the measurement blood bag temperatures and used for blood safety management – it’s a really useful item and well worth a read.

Temperature-sensitive labels are adhesive tags that display color changes at preset temperatures. There have been no studies of the suitability of this technology for measuring the temperature of blood components during transportation and storage. We used a digital thermometer to measure temperature in different locations inside containers of RBCs as they were allowed to warm to ambient temperatures following removal from refrigeration. We compared these temperature readings with those of 3 temperature-sensitive labels. These labels are marketed to alert transfusion services if the temperature of blood bags exceeds 10B0C, which is the maximum permissible by Food and Drug Administration and American Association of Blood Banks requirements for transporting RBCs. The contents of refrigerated RBC units changed from one homogeneous temperature to a range of temperatures when containers were allowed to warm (undisturbed) to ambient temperatures. Color changes of all 3 temperature-sensitive labels correlated more with core compared with surface temperatures of RBC units. These devices add an additional dimension of safety to the conventional 30-minute rule, which limits storage of blood components at ambient temperature to 30 minutes.

Read the full article here –  Temperature-Sensitive Labels for Containers of RBCs

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TESTO SAVERIS SUPPORTS MEDICAL ADVANCES

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Hardly a day goes by without the Testo Saveris radio and ethernet based humidity and temperature monitoring system finding a new use. The versatility and quality of Testo Saveris was vividly demonstrated by the recent installation at Quotient,  one of the world’s leading diabetes diagnostics businesses.

At the company’s modern premises in Walton on Thames, Surrey, Quotient is developing  point of care devices thaQDL montage copyt test levels of glycated hemoglobin (HbA1c) in blood.  Quotient’s products – Quo-Test and Quo-Lab –enable medical staff to regularly and easily check the health of a diabetic patient without having to send blood samples off-site for testing.  

Despite their apparent simplicity, Quotient Production Manager Dr Roger Kimber was anxious to ensure that the Quo-Test and Quo-Lab analysers and testing cartridges are assembled in the highest quality environment available. This is where the Testo Saveris enters the story.

As Dr Kimber observes there are numerous benefits of the Testo Saveris product. “ The wireless probes are easy to place and are unobtrusive within their locations. We have numerous varied needs across the operation such as refrigerators, the plant room, laboratories and the cold store for finished products including delicate consumables. Everything is always on display via my PC and the remote 24 hour alarm system including SMS texts gives me peace of mind.

The cost of the system was also within our budget and met ISO 13485. I would say it is certainly the best system of its kind on the market.”

For the record there are six of the Testo Saveris probes at Quotient, each  approximately the size of a SmartPhone running specialist software with simple operation measured in minutes and an intuitive PC-based user interface. The other key component is the discreet table-top base unit which can save 40,000 readings per measurement channel – the equivalent of a year of memory- as well as constantly displaying data and alarms for up to 150 probes supported by an integrated backup battery. As part of a comprehensive package of services, Testo can also supply validatable CFR software, fulfiling the requirements of the FDA’s 21 CFR part 11. This means that when used in conjunction with the CFR software, Testo Saveris is suitable for the most demanding of monitoring requirements in pharmaceutical application. Testo also provides an ongoing and essential calibration service.

For further details of Testo technology and support please call 01420 544433; email pr@testo.co.uk or visit www.testolimited.com

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