To Condition or Not to Condition … That is the Question

You already know that irreversible blood temperature indicators help ensure that the blood products you dispense stay within the appropriate temperature range. This can ultimately save money by reducing blood wastage, while also maintaining quality control.

The problem? Not all indicators on the market are created equal. The ones that require conditioning in some way don’t always meet the needs of today’s busy, fast-paced blood banks. Those I’ve spoken with say that ease-of-use is as high a priority as accuracy and reliability. That’s what Safe-T-Vue delivers.

Once our indicators are stored with your blood for 24 hours, the Safe-T-Vue 6 and Safe-T-Vue 10 do not need any conditioning. I’m often asked if the indicator needs to be heated prior to use or if it needs to go back into the refrigerator prior to use once it’s been applied to a blood bag. The answer to both these questions is no.

Safe-T-Vue indicators need only be stored in the refrigerator along with Red Blood Cells (RBCs). When RBCs are needed, a staff member simply removes an indicator and blood bag from the refrigerator and places the Safe-T-Vue on the blood bag.

It’s easily activated by folding over the “rounds” and snapping them together.

That’s it.

Other indicators on the market say they require “no conditioning” – but that’s simply not the case. One in particular has to be heated to a specified temperature for 60 seconds prior to activation. Another maps out “best practices,” which recommend putting the blood bag back into the refrigerator for 15 minutes once the indicator has been activated. The problem here is that the activation process can be delicate in the former example – and waiting for blood as in the latter, even for just 15 minutes, is very often not an option.

Here’s how it all breaks down.

To save even more time, inactivated Safe-T-Vue indicators can be adhered to blood bags as they are received – then put back into the refrigerator until needed for quick dispensing. You can then simply activate the indicator when blood product is requisitioned. And once activated, Safe-T-Vue indicators are good for 42 days compared to the other indicators that must come off the blood bag after each reissue.  This makes the Safe-T-Vue the only indicator that can be reissued multiple times on the same unit of blood.Safe-T-Vue 10 Blood temperature indicator for blood transport and temporary storage

If you have questions about how Safe-T-Vue works – and how it can save you valuable time compared to others on the market, please contact us. We’d also be happy to send you some Safe-T-Vue samples so you can see for yourself how easy they are to use.

Jeffrey Gutkind

jeffg@temptimecorp.com

Download VUEPOINT PDF

The Blood Supply Chain

Learning about the points of failure

We recently came across a white paper published by MaxQ Research LLC that breaks down the transfusion blood supply chain into “7 critical steps,” as illustrated in their infographic.  What was interesting to us is that the white paper discusses how in each of these steps “possible points of failure where any delays, miscommunications, or procedural issues can cause serious problems.”

Over the years, based on what we’ve learned from you, many past VUEPOINTs have focused on the fact that it’s the time blood products are out of your (blood bank) control where these delays or procedural issues can result in problems.  It’s for this very reason that many of you believe using an irreversible temperature indicator is the only way to know for certain that temperatures never exceed the 6oC or 10oC standard.

Before you dive into the entire white paper, which we encourage you to do, here are some key sections in the white paper’s introductory pages that we’d like to highlight, particularly when considering temperature indicators like Safe-T-Vue:

p. 5: Returned Blood and Blood Components

“Often there will be a need to return blood, blood components, to the blood bank/transfusion service.  This is possible only if:…

  • The appropriate temperature has been maintained….
  • The records indicate that the blood, blood component, tissue or derivatives have been inspected and that they are acceptable for reissue.”

While a qualified and validated storage/transport container validated for up to 24 hours may be used, there are well-known “points of failure in the blood supply chain” caused by human error.  If the blood product is removed from the storage container or cooler and left at room temperature, which happens in both the ER and OR, the blood could reach unsafe temperatures.  An irreversible temperature indicator like Safe-T-Vue is the only way to know if this exposure has occurred.  Use of an infrared thermometer or other temperature measuring device is not an adequate inspection method as the blood product may have been returned to the cooler and re-cooled – after having exceeded temperature standards.

p. 8: Cost of Blood Wastage is Significant

“Not only are blood products costly, but unnecessary losses or spoilage can result in shortages and put human lives at risk.  A more reliable and cost-effective solution is needed.”

Need we say more?

As the white paper points out, in 2010 the estimated direct cost of one unit of RBCs was $225.42, and this doesn’t account for overhead costs.  And then there is the truly unquantifiable cost and risk of a unit of temperature-compromised blood being transfused into a patient.

Learn more about blood transport packaging

You can download the white paper PDF and learn more about what hospitals and blood banks are using for shipping and storage today as well as the science behind these containers.

Many thanks to MaxQ Research for authoring and sharing this white paper. They would be delighted to entertain your questions and hear your reactions to their work.

As always, we also welcome your comments and questions, and appreciate the work that you do to maintain quality and integrity in your blood supply chain.

Sincerely,

Jeffrey Gutkind

p.s. The bibliography on the last page of the white paper is an excellent resource, be sure to check it out.

Make a New Year’s Resolution: Keep track of blood losses in your blood bank

Preserve precious resources, save money and optimize patient outcomes

I recently had the opportunity to visit a large metropolitan hospital that uses about 200 units of RBCs in the OR and ER every day. They were interested in learning about how temperature indicators might help them preserve their blood supplies, which is why I was there.

When I asked the blood bank supervisor how many units they lose each day she responded “zero.” A little further into the conversation, I asked her again and she said, “maybe a few per month.” Next, I asked her how many of those were lost because of temperature exposure. She didn’t know.

While a number as “low” as five units a month may not seem significant, particularly for a large institution, the costs can mount up quickly.  If one unit of RBCs is estimated at $250, for example, then losing “only a few” units each month can mean $15,000 to $20,000 a year.  And for smaller hospitals, losing even one or two units a month adds up to $2500 to $5000 annually.

And, as Dr. Robert A. DeSimone said in an interview with Medical Lab Management in 2017, “Blood products are a precious resource…we have tremendous respect for our blood donors and their provision of this valuable resource to our hospitals and patients.”  His point? Monetary cost aside, every unit of blood lost is the loss of a truly precious resource.

How can you determine what you are losing if you don’t keep track?

Some blood banks use a log to track blood losses.  Here’s an example of a simple grid that might help you get started:

Reviewing the grid regularly gives you the opportunity to tally your monthly losses, as well as look for any trends.  This can help you uncover the REASONS for the losses, which may give you insight into what measures can be taken to reduce or prevent those losses from happening. Download PDF of the Blood Disposal Log.

What improvements can be made when you do log blood losses?

One outcome of this logging exercise is evaluating whether or not you should actually be disposing of blood.  Is it safe to return to inventory, or not?

Scenario #1: Blood is not returned to the blood bank based on the 30-minute rule.

  • Result: There is no proof that the unit actually exceeded the recommended transport/temporary storage temperature. You could be disposing of a perfectly good unit of blood.

Scenario #2: Blood is measured with an infrared thermometer upon return to the blood bank and deemed viable.

  • Result: There is no proof that the unit didn’t exceed temperature guidelines during the period it was out of the blood bank (you can read more about infrared thermometers here). It may not be safe to return to inventory.

Scenario #3: Using an irreversible temperature indicator provides proof as to whether the blood should or should not be returned to inventory based on temperature exposure.

  • Result: You only return blood that has not been exposed to excessive heat to the blood bank, assuring patient safety and minimizing risk. Plus, you may be able to avoid disposing of some units of blood you may have otherwise – saving a valuable resource and money over the long term.

Are temperature indicators worth the expense?

Simply put, using an irreversible temperature indicator is the only way to have confidence that blood is safe to return to inventory – potentially preventing unnecessary disposal.  While there is an associated cost to using indicators, if you are able to save even one unit of blood each month, valued at $250, the cost of temperature indicators is quickly offset by the savings. Costs are also justified by the added peace of mind and your ability to preserve valuable blood supplies.

Jeffrey Gutkind
Jeffg@temptimecorp.comBlood Loss - Disposal Log Sheet

 

Keeping Blood Products Cold During Dispensing

Tests show that gel blankets significantly help maintain temps below 6oC

Test Blood Bag Warming using reusable ice packsOn a recent visit to a blood bank customer who uses Safe-T-Vue 6, we learned something that we felt was worth sharing. During the approximate 10 minutes that it often took to do paperwork and cross-matching, they sometimes experienced the Safe-T-Vue 6 (STV-6) “tripping.” This caused concern that the blood product may have been compromised by room temperature exposure, even for a seemingly short time period.

To address this problem, they began using refrigerated gel blankets (reusable ice pack sheets) to keep the blood product cool. Taking this simple step of placing the blanket around the blood bag(s) during preparation and before transport to the ER/OR has given them confidence that the blood product has been kept cool, and the STV-6 provides visual indication and reassurance that 6°C has not been exceeded.

Wanting to learn just how much the gel blanket helped, we turned to Marielle Smith, Technical Service Scientist in our Temptime Lab, to do some testing. You may be surprised by what we learned.

Read this VUEPOINT to see the test procedure and learn from the detailed data we gathered. It may inspire you to try gel blankets in your blood bank!

Tests to compare blood bag warming with and without refrigerated gel blankets

When blood banks are preparing refrigerated blood bags for transport to the OR/ER, there is limited time for blood bank personnel to record the necessary patient information (cross-check, paperwork, etc.) before the blood approaches critical temperatures. Many blood banks use Safe-T-Vue 6 for exactly this reason.

Previous studies have shown that bags warm quickly to temperatures (6.0°C in less than 10 minutes) rendering the blood unsuitable for use. Results from this new study, however, demonstrate that using a refrigerated gel blanket (such as the Thermafreeze Reusable Ice Pack Sheet) makes a significant difference in slowing the warming rate when the blood product is removed from refrigeration to typical room temperature conditions.

Test procedure setup

A test was performed to assess whether using a refrigerated gel blanket can add to the longevity of the blood bags upon removal from refrigerated storage (1°C – 4°C).

The test was setup to collect temperature data as follows:

1. Control, single bag with no gel blanket
2. Single bag with small gel blanket, cutout window (to view Safe-T-Vue 6)
3. Three bags with larger gel blanket

Six (6) bags of 350 mL simulated red blood cells volume were used for scenarios 1 and 2, and 18 bags were used for scenario 3.

Reusable Ice Pack Sheets (e.g., gel blanket) were obtained and cut into different dimensions to allow for testing either a single bag (with a window cut-out to view the Safe-T-Vue 6 indicator) or 3 bags side-by-side.

Small gel blanket with viewing window for 1 bag

Large gel blanket for 3 bags

Temperature measurement

Calibrated temperature probes were inserted into each of the simulated blood bags. Calibrated electronic thermometers (accuracy of at least ±0.1°C) were used to record the temperature of the fluid inside the filled blood bags.

After pre-conditioning in the refrigerator (maintained between 1°C to 4°C) for at least 24 hours, the bags and the gel blankets were removed and placed lying flat on a counter-top at room temperature conditions (19°C ± 1°C with 50% R.H). A timer was set to count-up mode and temperature readings were recorded at one minute intervals until the temperature inside the bag reached 6°C.

Test results

The data points on the graph below show the gradual warming of the bags as the refrigerated blood bags warm to 6.0°C in room temperature conditions when the blood bag is either wrapped in a refrigerated gel blanket, or left as is upon removal from refrigerated storage (control).

Summary

  • Without using a gel blanket, blood bags warmed from 3.2°C to 6.0°C in approximately 9 minutes
  • Using a small gel blanket (with a window cut out to allow for visual interpretation of the Safe-T-Vue 6 indicator), blood bags warmed to 6.0°C in approximately 25 minutes
  • Using a large gel blanket for testing up to 3 bags side-by-side, blood bags warmed to 6.0°C in approximately 32 minutes

Conclusions and recommendations

The results presented in this report support that a pre-conditioned refrigerated gel blanket can be wrapped around blood products to keep the blood below 6°C for an extended period of time – while blood bank personnel are preparing the blood for transport to the ER/OR.

When a simulated blood bag was wrapped in a refrigerated gel blanket upon removal from refrigerated storage (1°C to 4°C), the bag warmed to 6.0°C within about 25 to 32 minutes on a counter at room temperature conditions. As an added precaution, a Safe-T-Vue 6 indicator can be used to provide irreversible visual indication of temperature excursions beyond 6.0°C.

Order free samples of Safe-T-Vue 6

What is “stop temperature?”

Return to Refrigerator Challenge” generates new questions from blood banks

This was the most common question we received from blood bankers in an unprecedented response to our January 2017 VUEPOINT.  In that issue of VUEPOINT, we shared the results of a “Return to Refrigerator Challenge” – where a major university hospital conducted a test to compare two blood temperature indicators.  Their intention was to evaluate indicator performance when unused blood was returned to the blood bank.

Although this was the first time we discussed stop temperature in a VUEPOINT, it’s not the first time we’ve received questions about it from our blood bank contacts. To address those issues, we researched what stop temperature means for indicator manufacturers who use this specification. We found that stop temperature appears to relate to the chemical indication behavior.  This means that if the blood product temperature is below the stop temperature, the indicator does not change color.

How does a 10oC indicator with an 8oC stop temperature behave?

The 10oC indicator used in the challenge has a specified stop temperature of 8oC.  If the blood product begins to exceed the stop temperature (8oC), the 10oC indicator’s chemical indication material melts back to its liquid state. This melting reaction gives users a visual indication that the blood product is no longer in compliance. This type of indicator may signal that the blood product is out of compliance once it exceeds 8oC, even if it never reaches 10oC, as shown in this example.

What does this mean to blood banks using a stop temperature type indicator?

Now that we understand what stop temperature is, the question is what does the specification – and indicator performance – mean to blood banks?  Specifically, what happens if the blood product is hovering around the 8oC stop temperature for any period?

Tests shared by blood banks, combined with our studies, have shown that under a wide range of exposures and times – once the indicator exceeds its stop temperature of 8oC, the indicator may be irreversibly tripped.  In multiple tests, the blood product temperature was being internally monitored to confirm that it remained below the indication temperature of 10oC before being returned to the blood bank refrigerator.  After the blood bags were returned to the refrigerator for reissue, many indicators had tripped during the refrigeration period.

Comments and questions from blood banks based on findings

  • “Doesn’t this make it an 8oC indicator?”
  • “We have many bags that are returned to the blood bank at 8oC and they look OK. We put them in the refrigerator and they show overheated.  This is an 8oC indicator.  We are throwing out good blood.”
  • “This did not show up in the standard validation, and it never occurred to us to try this while performing the validation. After performing the ‘return to refrigerator challenge’ we found that the indicator just did not perform”.

We are grateful for comments and questions like these because they help fuel our blood indicator knowledge and testing.  Clearly, the “stop temperature” specification may be new to many blood banks and is something to be further explored.  Please share your experiences and observations so we can continue learning together.

Validating Temperature Indicators: The “Return to Refrigerator” Challenge

Learn more in this VUEPOINT about indicator comparison tests we conducted based on reports from blood banks experiencing indicators “tripping” after returning blood products to the refrigerator

by Jeffrey Gutkind, Temptime

We are often called on by blood banks to answer questions about temperature indicators and support their validation requirements.  They also interface with us when they are having “issues” with an indicator, whether it’s Safe-T-Vue or a competing product, and are looking for insight and possible solutions.

Temperature indicators “tripping” after return to refrigerator

Several times over the past year we’ve interacted with blood banks experiencing a specific temperature indicator problem.  Here’s how it goes – the unused blood is returned to the blood bank and the indicator shows that it is still in compliance, that it hasn’t exceeded its 10oC indication temperature.   Great!  So, the blood is returned to the blood bank refrigerator for future reissue.

Then, at a later time, the when the blood is removed from the refrigerator for reissue –the indicator has “tripped” or turned color.  How could this be?  If the temperature was in compliance going IN to the refrigerator, how could it then be out of compliance AFTER being refrigerated?

The “Return to Refrigerator Challenge”

Blood Temperature Indicator Comparison

Figure 1: “Return to Refrigerator Challenge” Temperature Indicator Test Setup

In response to this influx of concern from blood banks, we decided to conduct a comparison test.  Fortunately, we had an opportunity to work with a major university medical center to gather validation data focused specifically on the “return to refrigerator” portion of the blood product’s journey. We refer to this test as the “Return to Refrigerator Challenge.”

The purpose of the challenge was to simulate a typical blood product journey – blood being issued to another department, such as the OR, and removed from the cooler for a brief period of time, and then returned to the blood bank.   A temperature probe would be placed in the blood bag, and the performance of two types of 10oC indicators would be compared.

  1. A probe was inserted into a (simulated glycerol-water) blood bag, which was placed in the refrigerator until it reached 4.2oC.
  1. The bag was removed from the refrigerator. Five Safe-T-Vue 10 indicators and five ‘Indicator A’ were affixed to the blood bag. (Figure 1)
  1. The blood temperature was allowed to reach 8.5oC. The indicators were observed and observations recorded (Figure 2).
  1. The blood bag was placed back in the refrigerator at 4.2oC (to simulate blood being returned to the blood bank for reissue) for 30 minutes.
  1. After 30 minutes, the blood bag was removed from the refrigerator. The indicators were observed and observations recorded (see Figure 2).

Figure 2: “Return to Refrigerator Challenge” Indicator Pass and Fail Data

*Note: Accuracy of Safe-T-Vue 10 is +/- 0.4oC and published accuracy of Indicator A is +/- 0.5oC

Challenge proves need to validate indicator performance throughout journey

Comparing the performance of the two indicators (Figure 2), it was apparent that the Safe-T-Vue indicator had accurately performed as expected and within the specifications.   Two of five ‘Indicator A’ had prematurely indicated (at 8.5oC) prior to refrigeration, and all five had failed to perform to specification after refrigeration at 4.2oC for 30 minutes.

Based on the manufacturer’s published accuracy specifications, Safe-T-Vue performed successfully, whereas ‘Indicator A’ failed to perform to specification.  Not only did 2 out of 5 ‘Indicator As’ “trip” at 8.5oC, all five of the indicators had tripped within 30 minutes of being refrigerated at 4.2oC.   This may be due to Indicator A’s published “stop temperature” of 8.0oC.

Is it necessary for you to conduct your own “challenge?”

This “return to refrigerator challenge” proved that the Safe-T-Vue indicator could be validated for returning blood products to the blood bank. If you have confidence in the performance (to specification) of the indicators you are using, then you probably don’t need to conduct your own “challenge.”  But, if you’ve had issues like we described early in this VUEPOINT, where indicators are mysteriously changing while under refrigeration, you may want to conduct the “challenge” to be certain that the indicators are performing as specified.

Validate critical points in your process to confirm indicator performance

The typical, standard validation should help you identify indicators that do not perform to specification (for example the two Indicator A’s that tripped at 8.5oC, which does not meet the published specification of +/- 0.5oC).   The closer look of the “challenge” could be used to confirm additional failure to perform to specification, particularly in situations where the indicator performance seems odd or questionable.

As always, we welcome your feedback on this topic.  And if we can provide validation support or help you address any temperature indicator issues, please contact me.

Jeffrey Gutkind

3 Things You Need to Know

About Blood Temperature Indicators

Do you trust a product to protect your blood supplies that may “auto activate?” Would you be discarding expensive blood products because of an unreliable indicator?

1. Accuracy Matters

Of the indicators on the market, one is clearly less accurate. “Indicator A” can reach endpoint at 9o, resulting in wasted blood – blood that may actually be in compliance.

2. Performance Varies Greatly

The fine print for a competing indicator clearly states that AFTER ACTIVATION, the temperature of the blood needs to be brough back down to its 8oC “Stop Temperature” to avoid premature indication.

This means that the indicator could prematurely indicate at a temperature as low as 8oC if the blood bank doesn’t take the extra step to ensure that the blood – after attaching an activated indicator – is cooled below this “stop temperature.”

3. Lower Price May Not Be Lowest Cost

Comparing indicator purchase price may make it seem like an easy choice.  however, the actual COST of an indicator that is:

  • poor performing
  • less accurate, or
  • unreliable

is dramatic in comparison to the cost of wasted blood products.

Knowing that, on average:

  • blood banks receive a significant amount of issued blood back
  • ONE unit of wasted blood may cost the blood bank $250
It only makes sense that a more reliable indicator that reaches endpoint at 9.6oC (and not as low as 8.0oC) is a more cost effective choice.

Handy Tip

Safe-T-Vue lot-by-lot QA documents are posted here on our website for easy customer access – and prove that Safe-T-Vue is manufactured to quality standards.

 

IR Thermometers: Determining Blood Product Temperature on Return to Blood Bank

Learn as we explore common misconceptions about IR thermometers and surface temperature vs. core temperature

The following PathLabTalk post describes something we encounter repeatedly in blood banks – and illustrates several problematic misconceptions about determining blood product temperature on return to the blood bank. At the same time, this post demonstrates a reliable, good practice!

“Our transfusion service is looking for an infrared thermometer that we can use to determine the internal temperature of our donor units. We issue products in validated coolers to surgery, ED, and other locations and sometimes we receive the products back that have not been used. Currently, we attach a temperature indicator to the unit, but want something more accurate that is not difficult to operate, calibrate, etc….”1

First, we congratulate this PathLabTalk poster for reaching out to the blood bank community for ideas and support. She/he has realistic, everyday needs that many may identify with. In this VUEPOINT, we present some problems and misconceptions, along with this blood banker’s good practices, that are communicated in the post.

Problem #1
Infrared Thermometers (a.k.a. Infrared “Guns”) do not measure “internal temperature”

Infrared thermometers are used to measure surface temperature without contacting the product being measured. Most specifications for these devices state “non-contact surface temperature measurement.” They do not measure “core temperature” of any product, including blood. Infrared thermometers are used in many different applications ranging from food service, to residential heating/cooling, to industrial. Typically they are used for “hard to reach” areas where contact temperature measurement is difficult/impossible.

Problem #2
A one-time temperature reading of a returned blood product provides little assurance that the blood was kept at the correct storage or transport temperature over the entire time period that it was out of blood bank control.

No matter how well everyone is trained and how conscientious they are, we all know that once the blood product leaves the blood bank, anything can happen. For example, in the OR or ED there are many critical functions being performed at once, and often over long periods of time. Blood can be taken from the cooler and left on a table for hours – and then returned to the blood bank, having had time to “cool” to what may appear to be an acceptable temperature.

The precariousness of this situation is compounded when an IR thermometer is used to check SURFACE temperature when the product is returned.
• Perhaps the blood bag was placed on an OR table for 6 hours during a long procedure, but was placed back in the cooler just long enough for the SURFACE to cool to a seemingly “acceptable” temperature…?
• Is it safe to assume that the blood temperature never reached unsafe temperatures?

Problem #3
Accuracy of IR Thermometers is affected by how they are used – due to “Distance to Target” A.K.A. FOV (Field of View) or D/S Ratio (Distance to Spot)

Accuracy specifications for most IR thermometers range from +/- 1.0oC to +/- 2oC. Looking at a few models from major manufacturers, their D/S specifications are documented as: 1 meter, 1.5 meters and 2 meters – which might surprise blood bankers using IR thermometers. The distance between the device and the target (blood product) affects the reading accuracy – and also means that the dependability and repeatability of temperature readings is “user dependent” in how they use the IR thermometer from variable distances (you’ll read about this problem in the PathLabTalk post responses). If you’d like to learn more about this particular characteristic, Grainger (industrial and facilities maintenance equipment resource) has an excellent “Quick Tip” on IR thermometers.

Good Practice

Temperature indicators provide irreversible visual evidence if the blood product exceeds its specified temperature, even if the product is “re-cooled” prior to return to the blood bank.
Attaching an irreversible temperature indicator to the blood product, as done by the PathLabTalk poster, IS one way to know if the blood was maintained at correct storage/transport temperatures. When the blood product reaches the indication temperature (typically 6oC or 10oC), the indicator provides “irreversible” visual evidence of the temperature excursion – even if the blood product is “re-cooled” after being out of blood bank control.

This elicits a similar question that we raised regarding IR thermometers – do temperature indicators that adhere to the surface of the blood product provide indication of the surface temperature or core temperature?

Safe-T-Vue indicators (Temptime Corporation) are chemical indicators, and the algorithms that are used to formulate them are based on thousands of laboratory tests that incorporate the CORE blood product temperature. While the indicator may be applied to the surface, its color response is correlated to core temperature.

Why this all matters

Bacteria are very rarely transmitted during blood component transfusion, but if they are, they usually cause severe, life-threatening adverse reactions, with the mortality rate of 20-30%.2

Periodically, there are reports of incidents likely to have caused serious injury or death, that have been linked to bacterial sepsis from blood products that were dispensed for extremely long surgeries, and returned to the blood bank unused.3 Those very products could be returned to inventory after checking the temperature with an IR thermometer, and reissued to another patient. Unbeknownst to the blood bank, the blood products may have reached temperatures that allowed for contaminants to thrive. When that unit is then reissued and transfused to the next patient, the results can be catastrophic.

Kudos to the PathLabTalk poster for good practice

In summary, we understand that it’s unrealistic to assume that blood products will be handled outside of the blood bank with the same watchful eye and expertise that trained, focused blood bankers have. And there is little certainty of blood product maintenance at appropriate storage/transport temperatures, even when using a temperature sensing device to check the product on return to the blood bank.

The most sure way to know that the blood did not reach non-compliant temperatures – that could result in bacterial sepsis – is to use an irreversible temperature indicator that stays with the blood product during its entire time out of the blood bank – as the PathLabTalk post noted.

References
1. http://www.pathlabtalk.com/forum/index.php?/topic/6436-infrared-thermometer/

2. http://cdn.intechopen.com/pdfs-wm/27955.pdf

3.  http://www.jsonline.com/watchdog/watchdogreports/problems-at-hospital-lab-show-lax-regulation-hidden-mistakes-b99585186z1-330324081.html

The Results are in: Platelet Indicator Survey

65% would definitely use a platelet indicator, and another 12% said “maybe” or in special situations

Thank you to the 115 of you who participated in our October survey about platelet management and provided your feedback on a platelet temperature indicator. We’re excited to share what we learned….. and even more excited to tell you what we plan to do about it!

A few fast facts from the survey:

  • 65% would definitely use a platelet indicator and another 12% said “maybe” or in special situations

  • 80% of those who would use an indicator want a dual range indicator (20-24oC)

  • Reasons for not returning unused platelets to inventory (most common comments): (1) Time out of blood bank, (2) Uncontrolled/unmonitored environment, including temperature and lack of agitation and (3) Spiked bags, defaced labels

  • 75% of respondents take platelet temperature on return to the blood bank (but few have temperature monitoring during the time period the platelets are out of blood bank control)

The complete Survey Results are presented at the end of this VUEPOINT post.

Interest confirmed at AABB

To further explore the topic, we had a chance to talk about platelet management with many of the blood bankers at AABB. What they told us only validated what we learned in the survey – with patient safety always at the forefront, blood bankers need a better way to both (1) assure temperature compliance and (2) preserve precious platelet supplies. A temperature indicator would monitor platelet “temperature history” for the entire period it is out of blood bank control.

You’ve spoken and we’ve heard you

These recent interactions have revealed a potential new product need in the market. At Temptime, we have initiated the first steps of our new product development process focusing on a dual-range indicator for platelets. We are working to develop a deeper understanding of your needs and identifying potential product and technology solutions..

Get involved!

Temptime’s product development process depends on user input and field trials. If you’d be interested in providing input to the initial design and specifications for this new product development, we welcome your participation. Please email us and we will be in touch with you.

Survey Results

Q1: “Comments” Summary

  • 5-6 responses relative to time away from blood bank, lack of monitoring
  • 3 responses specific to agitation

Q1: “Other” Summary

  • 11 relative to time out of blood bank
  • 7 storage/uncontrolled environment
  • 7 spiked or modified bag/label
  • 5 “no swirling” observed
  • 4 noted “agitation” concerns

Q2: “Other” Summary:

  • 13 relative to time away and/or lack of monitoring/controlled environment (some specified >30 mins, > 2 hours)
  • 11 expired

Q3: Most common Text Responses summary:

  • 36 take temp with thermometer or temperature plate
  • 20 take temperature with IR thermometer
  • 16 “take temperature” (unknown how)
  • 13 use “touch/feel”
  • 7 report platelets returned in cooler, on ice or from fridge
  • 5 report that temp is monitored every 4 hours or constantly, or kept in temperature controlled chamber
  • 4 discard due to time

Q6: Most common Text Responses summary:

  • 6 report low usage or returns
  • 5 reference cost
  • 3 indicate would take temperature if unsure, indicator not needed 

Q8: Most common Text Responses summary:

  • 17 expired/outdated
  • 10 wrong/poor storage, including use of coolers
  • 7 time away from blood bank/control
  • 3 agitation concerns
  • 3 spiking bag and returned

SURVEY: Temperature Indicators & Platelet Bacterial Contamination

“Sepsis from a bacterially contaminated platelet unit represents the most frequent infectious complication from any blood product today.”1

Would a temperature indicator help your blood bank improve quality control, patient outcomes and platelet discard rates?
Take the Survey: Click Here

Because platelets are stored at room temperature, their shelf life is limited to 5 days due to the risk for bacterial growth during storage. Bacterial contamination of platelets is a major concern because of the rich plasma environment at room temperature. All apheresis platelets are sampled and cultured for bacteria growth prior to issue. Platelets that have exceeded the AABB guideline temperature range (20 – 24°C) are at greater risk for elevated bacterial counts. When this happens, not only is the patient risk high, but there are also intense challenges on the blood bank to maintain adequate platelet supplies AND assure patient safety.

As a major manufacturer of temperature indicators for healthcare applications, we are interested to hear from you about the possible application of a temperature indicator for platelets (PLTs). For that reason, we’re conducting a survey.

Publications on Platelets

Just this past November, AABB published clinical guidelines on appropriate use of platelet transfusion in adult patients, developed by a panel of twenty-one experts (named in the article). These guidelines appear in the February 2015 issue of Annals of Internal Medicine. While the article provides six recommendations specific to platelets and transfusions, it states early in the article that:

“Sepsis from a bacterially contaminated platelet unit represents the most frequent infectious complication from any blood product today.”1

In a 2011 article in Transfusion, the author noted that “…outdating PLTs is a financial burden and a waste of a resource.”2

In response to this recent attention to platelets, we’ve considered whether an irreversible temperature indicator for platelets would help protect patients AND reduce the financial burden associated with outdated PLTs.

Please CLICK HERE to take our survey
and share your thoughts.

In this short survey, we’d like to learn more about your blood bank’s platelet inventory management – and to get your ideas on the possible value of a platelet temperature indicator.

After the survey closes, we’ll publish the responses so you can learn from each other. Survey participants will receive a pre-release of the results – and also be entered in the AABB drawing in Anaheim to win a FREE Val-A-Sure Cooler Validation Kit!

Thank you for taking time to participate in the survey. We look forward to your input, and are happy to provide a forum for sharing ideas in VUEPOINT.

Jeff Gutkind
jeffg@temptimecorp.com

For the entire AABB Guidelines: A Clinical Practice Guideline From the AABB.

Sources:
1 Stramer SL. Current risks of transfusion-transmitted agents: a review. Arch Pathol Lab Med. 2007; 131:702-7.

2 Fuller AK, Uglik KM, Braine HG, King KE. Transfusion. 2011 Jul;51(7):1469-76. doi: 10.1111/j.1537-2995.2010.03039.x. Epub 2011 Feb 8.

COMZ VUEPOINT (doc. 2371)