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WARNING: This is both an informative article and a rant. It is long and detailed.
I remember having a conversation with someone saying that Strive For Five was a hard to understand document, ambiguous in parts, and just confusing in many spots. They argued that it was all straight forward and simple. Over the years I have had many discussions with people about what is actually in Strive For Five and what is not. I am finally over it. Here is my section by section break down of Strive For Five in regards to what it says in regards to temperature monitoring. Feel free to give us feedback if you think we have it wrong. Also keep in mind, this article is focusing on what is written in Strive For Five, not what is enforced by different organisations.
Most of the problems interpreting Strive For Five are caused by people skipping the Glossary. There are some critical definitions that you must be aware of
“A small electronic device that continually measures temperatures and keeps a record of the results”.
That’s easy. Clever Logger is a data logger. LogTag is a data logger.
“Wireless temperature-monitoring systems that provide real-time temperature readings, and email or text message alerts when a temperature excursion outside the recommended +2°C to +8°C range occurs.”
Clever Logger is an automated temperature monitoring system. LogTag is NOT.
“A computer based control system that alerts staff when a temperature excursion outside the recommended +2°C to +8°C range occurs.”
This is not as fancy as an automated temperature monitoring system. It is just an alarm indicator to say there is a problem. There is no notification of how hot or cold the fridge is. Most vaccine fridges have an alarm relay that can be connected to a security panel, that would then go back-to-base.
Clever Logger is NOT a back-to-base system. LogTag is NOT.
There is NO DEFINITION OF WHAT THE THERMOMETER IS in the glossary.
While it may seem obvious what a thermometer is (“a device to measure temperature”), it does become an issue when working out what Strive For Five is actually talking about.More on this later.
Strive For Five is all about ensuring vaccines are stored between 2°C and 8°C, with the optimal temperature being 5°.
It also have provision for the temperature reaching up to 12°C for up to 15 minutes.
It then has the vague “Monitor the temperature of vaccine refrigerators twice daily, or more if required (see Section 4 “Vaccine temerpature-monitoring devices’).
No indication as to what “monitor” means. We wait patiently for section 4.
Vaccines must be stored between 2°C and 8°C.
In section 3.1, it lists an advantage of a vaccine fridge as “inbuilt digital temperature monitoring (inbuild data logger) and/or digital temperature indicators (minimum and temperature displays)”
Just to confuse the jargon, this is described as a “temperature display” and not a thermometer.
Now the rubber is starting to hit the road.
“To ensure that vaccines have been stored within the recommended temperature range of 2°C and 8°C, the temperatures to which vaccines are exposed must be monitored, recorded and reported throughout the cold chain.”
Issue 1: the “temperature to which vaccines are exposed must be monitored”. This means monitoring the air-temperature, but the actual vaccine temperature will change far slower. No logger complies with this requirement because they all have a slower response time. This is a good thing, but it does make it very difficult to compare two devices.
“Several vaccine temperature-monitoring devices can be used to monitor the cold chain. These include temperature chart recordings systems, data loggers, thermometers, disposable cold chain monitors, automated temperature-monitoring systems and back-to-base systems. At a minimum, all vaccine refrigerators must have a basic data logger and thermometer to continuously monitor refrigerator temperatures.”
Once again, no definition of what a thermometer is.
You must have both a data logger and a thermometer to monitor your vaccine fridge.
Section 4.2 now covers “what is a data logger”.
“Temperature data loggers are small electronic devices that measure temperatures at preset time intervals and record the results over a period of time. Data loggers should be set to record temperatures at 5-minute
intervals.”
Loggers must be set to sample every 5 minutes.
WARNING: There are some loggers on the market that do not sample fast enough to comply.
“Each logger is a self-contained miniature computer. Data loggers come in a range of shapes and sizes. Once programmed using a computer, loggers are disconnected from the computer and placed in the vaccine refrigerator near the temperature probe or vaccines. The logger then operates independently on its own battery until the recording is downloaded to the computer.
Some purpose-built vaccine refrigerators have an inbuilt data logger. Information from the data logger should be downloaded at least weekly (or more frequently if recommended by the manufacturer), reviewed and digitally stored.”
This describes temperature loggers like LogTag and other loggers. This was the technology that was just starting to become affordable when the first edition of Strive For Five was released (nearly 20 years ago).
“Advances in technology are producing more features in data loggers; the information in this section refers to basic models.”
Ironically the 2019 edition of Strive For Five, which was meant to bring the standard up to date, completely neglects to address wireless loggers. By the time it was released there were already a number of wireless loggers on the market, and Clever Logger meant that it was affordable for all pharmacies and GPs. Strive For Five edition 1 was all about encouraging the industry to move from bar fridges to domestic or vaccine fridges. Edition 3 could have been about encouraging the industry to move onto a fully automated system. Instead, it buried its head in the sand.
Issue 2: Nothing that you are about to read refers to advanced temperature loggers, like Clever Logger.
I am going to repeat this point a couple of times.
“Data loggers provide an accurate indication of vaccine refrigerator temperatures and can be used to map ‘cold spots’ or investigate problems. Loggers use a similar measuring principle to chart recorders; however, they record the data electronically. The data can be stored by the monitoring system and can also be downloaded to a computer.
The objective of data logging is to build up a ‘temperature map’ for the refrigerator (see Section 5.4 ‘Stabilising the vaccine refrigerator temperature’), to identify which areas are safe for vaccine storage. In particular, it is important to identify areas where vaccines could freeze.”
At this stage there doesn’t seem to be much controversy, but hang onto that thought of mapping “cold spots”.
Twice-daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in the cold chain. If a data logger is used for routine temperature monitoring (instead of a minimum/maximum thermometer), it must have a visual display of minimum/maximum temperatures to allow twice-daily real-time readings to be viewed and manually recorded.
If a traditional temperature logger is used, the vaccine fridge must still be checked twice a day.
Issue 3: This clause is in the section that only refers to basic models.
The requirement for the twice daily check is to provide “a timely breach in the cold chain”. Systems like Clever Logger will automatically notify the user the moment the breach occurs. The vaccine fridge will also be producing an audible alarm to notify the staff who are near by. The need to do a twice daily check is totally redundant. The writers for Strive For Five were probably aware of this, but did not write a policy in regards to an automated system.
Now how to use the data logger:
“The data logger and the minimum/maximum thermometer should be co-located in the refrigerator; otherwise, different recordings can occur. If the data logger and probe have a fixed position in the refrigerator and cannot be moved, the vaccines should be stored as close as practicable to the probe.
The temperature logger should ideally be next to the thermometer.
Issue 4: What is the minimum/maximum thermometer?
Historically the minimum/maximum thermometer was an actual thermometer. This makes sense of the “should be co-located” statement. They are trying to ensure that the same location is being monitored so the readings should be the same.
Most users, however, now use the built-in minimum/maximum thermometer built into the fridge. This is the display on the outside of the fridge. If this is used as the minimum/maximum thermometer then a number of issues arise:
Issue 5: You can’t store the vaccines near the probe in most vaccine fridges
The probe in many vaccine fridges is not within the actual fridge unit. It is not near the actual shelving.
Issue 6: You can’t co-locate the logger next to the probe
Likewise, it is impossible to place a temperature logger next to the built-in probe. This means that the logger is now monitoring a different location within the fridge, and that will raise another issue that we will discuss soon.
“The results from the data logger can be printed in graph and numerical formats, including times that the temperature was recorded outside the +2°C to +8°C range, and the minimum and maximum temperatures.”
Nothing too controversial here. What’s great is that Clever Logger can automatically email this to you.
“All staff should be trained in how to operate and manage the data logger and interpret its readings. “
All staff need to be trained in how to use the data logger, not just the one person who is normally responsible for it.
We sell a number of different brands of temperature loggers. Our experience is that there is normally only one person who knows how to use them. When they are away, and something goes wrong, we will have someone call us in a panic trying to retrieve the results. We can’t stress how important training is.
And moving on:
“All vaccine refrigerators should have a permanent data logger in place to continuously measure the refrigerator temperature at preset 5-minute intervals. The data should be downloaded at least weekly, in addition to twice-daily minimum/maximum recordings. The data logger can be a
portable digital data logger or may be built into the refrigerator.”
If a traditional temperature logger is used, the data should be downloaded at least weekly.
A wireless system like Clever Logger will automatically download the data every couple of minutes. That is part of the reason why this section does not apply to advanced loggers. Unfortunately some people have interpreted this clause to mean that the user must look at the log every week. There is no indication as to the intent of this clause, but my guess is to minimise the amount of data that is lost if the logger dies or was not used correctly. It is not to ensure that the fridge is working correctly, because that is the purpose of the twice daily check.
These are only “points to consider” and not a requirement. There is no guidance as to what is an acceptable or unacceptable answer, so I won’t list any key requirements here.
Find out:
I love check lists. This should simplify things. I will also skip repeating key requirements that have already been listed:
The logger needs to be in the middle of the vaccines.
Issue 7: The logger was meant to be next to the probe. Now it is in the middle of the fridge.
Issue 8: The requirement is to compare the logger with another logger. There is no indication as to how often (“regularly”) and what an acceptable variation is.
This throw away clause has actually caused a huge number of technical issues as to why two loggers, side by side, won’t always agree with each other. There’s another blog post on this and I won’t cover it here.
Finally, we can start to learn what a thermometer is, and how to use it.
Choose a thermometer that reads Celsius (not Fahrenheit). Ensure that the thermometer has a sensor probe. To ensure that the probe is measuring the temperature under the same conditions as for the vaccines, place the end of the sensor probe in an empty vaccine box inside the refrigerator.
The thermometer must read Celsius.
The thermometer must have a probe, and that probe needs to be in a box inside the refrigerator.
Issue 9: This definition of a thermometer excludes the built-in temperature sensor of the fridge.
The built-in sensor can not be placed in a box within the refrigerator. Many vaccine fridges have the sensor outside the refrigerated compartment.
These are only “points to consider” and not a requirement. There is no guidance as to what is an acceptable or unacceptable answer, so I won’t list any key requirements here.
Thermometers require annual checks to ensure accurate measurement. Flat batteries, or a damaged probe or cable can affect readings. Change the battery at least every 6 to 12 months and record the date it is changed. In the absence of a data logger, it is useful to have a back-up thermometer and to note its storage location in the vaccine management protocol .“
Once again, the language of this clause implies a discrete thermometer. It isn’t stating that it has to be, but it also doesn’t say “if the thermometer has batteries…”.
It is a pity that they didn’t define thermometer in the glossary. This just makes things worse…
“A minimum/maximum digital thermometer is essential for temperature monitoring during mobile or outreach immunisation sessions and power failures. Some purpose-built vaccine refrigerators do not have a battery back-up for their temperature-monitoring systems. A battery-operated minimum/maximum thermometer can assist in monitoring refrigerator temperatures in an emergency.”
The thermometer must be able to operate during a power failure.
Issue 10: Most vaccine fridges do not record the temperature during a power outage.
The displayed min/max temperature on many vaccine fridges is not updated during a power outage. They do not comply with this requirement, and a battery powered min/max thermometer is required.
There are steps on how to do a slush test and why. I’m just going to jump to the interesting bits:
“A check of the accuracy of your thermometer is recommended:
• after the battery is changed
• at least every 12 months, for auditing purposes
• if there are cold chain problems.
The supplier of the thermometer may be able to offer a validation or accuracy check for their product.”
You need to test your thermometer regularly using the slush test.
NOTE: This section ONLY APPLIES TO THERMOMETERS, NOT LOGGERS.
Issue 11: The slush test only applies to thermometers, not temperature loggers.
We have often been asked how to run the slush test on temperature loggers. This is not intended to be a test for temperature loggers. There are a number of issues when trying to test a temperature logger (see this article). They can damage the logger, and they are not reliable.
Now we are starting to talk about Clever Logger:
“Automated temperature-monitoring systems allow immunisation service providers to access real-time temperature-monitoring data from a connected device such as a computer or phone. The temperature readings do not need to be downloaded to a computer. These systems use wireless monitoring to transmit continuous data to a web server. In the event of a cold chain breach, an alert is sent by text message or email to the registered user. These systems are used more frequently in larger facilities to monitor multiple refrigerators in real time, but can be used in small facilities for 24-hour access to information.
Contact your state or territory health department for further information about monitoring requirements“
Disregard a large chunk of what you have just read. Instead, contact your state or territory health department for further information.
But they will just tell you that it needs to comply with Strive For Five.
Issue 12: No-one actually knows what to do with an automated temperature-monitoring system
All the way back in section 4.2 we were told that the information does not apply to advanced loggers. Now we have the section on what does apply to advanced loggers and there is no information. Contacting a state or territory department for further information just ends up with the “it must comply with Strive For Five” answer.
There is almost a comedy skit ready to be written about this.
Many of the key requirements listed so far only apply to traditional loggers, including the need to check your min/max thermometer twice a day.
Now we are NOT talking about Clever Logger.
“A back-to-base alarm system is a computer-based control system that alerts staff when a temperature excursion outside the recommended +2°C to +8°C temperature range occurs. A nominated clinical staff member or position must be alerted. Use of back-to-base alarm systems to monitor refrigerator temperatures is more common in larger facilities and still requires temperature readings to be downloaded to a computer.
Even if a back-to-base alarm system is used, immunisation service providers must still manually record minimum and maximum temperatures twice daily as a timely alert to any breach in the cold chain. Contact your state or territory health department for further information about monitoring requirements.“
The concept of an automated temperature-monitoring system and a back-to-base alarm system sound vaguely similar, but there is one HUGE difference in their use:
Back-to-base systems are not a substitute for a twice daily minimum and maximum reading.
Issue 12: Strive For Five specifically states that twice daily checks are required for a back-to-base system, but no similar mention is made for the automated system.
The reason is simple – a back to base system only tells you when a problem occurs. It does not tell you how bad it was. The user has no knowledge of how warm or cold the fridge became. You need to see a min/max thermometer to get this information.
An automated temperature monitoring system, on the other hand, not only tells you when a problem occurs, it also gives you live updates on what the temperature is as well as historical information on how bad it had been.
Strive For Five did not go as far as saying that there is no need to do the twice daily check. Now the industry is stuck in inaction because no-one is prepared to challenge a practice that has been going on for decades.
Section 5 is titled “key recommendations for effective vaccine storage management”. Unlike section 4, it is a series of recommendations and then followed by the rational behind them. This means that:
1. they are not mandatory,
2. we can see the intent and consequently we can judge if another solution is better.
Section 5.6 reads like a repeat of everything we have already discussed:
“Ensure that procedures are in place to provide written records of these activities every day the facility is open, in a chart or logbook specific to each
refrigerator:
• Check and record the vaccine refrigerator temperature (current, minimum and maximum) twice daily: before the refrigerator is used for the first time and at the end of each day. If the temperatures are outside the recommended +2°C to +8°C range, immediately implement cold chain breach protocols (see Appendix 3). See Appendix 5 for a sample monitoring chart.
• Check and consider the vaccine refrigerator temperature each time before opening the refrigerator door and retrieving a vaccine; the temperature does not need to be recorded each time.
• Reset the data logger or thermometer after each reading.
The refrigerator temperature also needs to be read and recorded:
• on receipt of vaccines
• following a power failure or other cold chain breach event
• hourly during mobile or outreach immunisation clinics
• weekly when downloading data loggings
• after any routine maintenance on the refrigerator, such as minor cleaning.
The written record of refrigerator temperatures enables staff to monitor temperature fluctuations and take action if temperatures go outside the recommended +2°C to +8°C range. Retain documentation of vaccine temperature recordings according to your state or territory health department policy, or your medico-legal and statutory requirements.
Note:
• The data logger or thermometer must measure temperatures in Celsius, not Fahrenheit.
• Each vaccine refrigerator requires its own temperature-monitoring chart/logbook.
• Data loggers provide an accurate indication of the vaccine refrigerator’s temperature at preset 5-minute time intervals, and are useful for mapping
cold spots in the refrigerator or investigating cold chain problems (see Section 4.2 ‘Data loggers’).
If temperature readings are outside the +2°C to +8°C range, follow the cold chain breach protocol, download information from the data logger
and contact your state or territory health department for advice. See contact details on the last page of these guidelines.”
But the great insight comes into the rationale:
“Checking and recording the refrigerator temperature before retrieving a vaccine enables problems to be identified before the vaccine (which may be damaged) is administered. Twice-daily temperature checks give an indication of any problems in the refrigerator’s function and temperature fluctuations over the course of the day. However, the temperature needs to be viewed and considered every time the refrigerator is opened.”
It is all about ensuring that vaccines are stored at the correct temperature and eliminating the chance that a vaccines are taken from a malfunctioning fridge. Twice daily checks are a poor attempt to do this, and more frequent checks are required.
Issue 13: Strive For Five acknowledges that a twice daily check is inadequate, but is only able to suggest a manual solution.
Clever Logger doesn’t just do a check when the fridge is used, it checks it every 5 minutes. That is the optimum solution. It exceeds the rationale behind the manual checks.
One final section that is a bit controversial:
• Recalibrate the data logger annually or according to the manufacturer’s recommendations.
• Change the data logger battery at least every 6 to 12 months or as indicated by the manufacturer.
• Check the accuracy of the thermometer at least every 12 months (see Section 4.4 ‘How to check the accuracy of a thermometer [‘slush test’]’).
• Change the thermometer battery at least every 6 to 12 months or as indicated by the manufacturer.
Thermometers need a slush test annually.
Temperature loggers need to be recalibrated according to the manufacturer’s recommendations.
Issue 14: Strive For Five doesn’t actually say what needs to happen with temperature loggers, but there is a growing expectation that they are NATA tested each year.
There is a bit of confusion as what is “recalibration” and “certification”. Strive For Five talks about recalibrating loggers, but that’s not how digital sensors work. It’s a hangover from the days of analog.
But the joke is, a NATA certificate will actually cost more than a new logger. That’s a piece of paper that states that your logger is still working OK.
The industry is moving in the direction of overpriced certification, instead of sticking to the manufacturer’s recommendations.
That’s why we are offering a significant discount to anyone who wants to simply replace their logger each year to avoid this stupidity tax.
A slight tangent on this one. Section 6.1 has this point about the vaccine fridge being “fit for purpose”
• Does the refrigerator have an inbuilt data logger to continuously monitor temperatures?
Issue 15: Strive For Five totally failed to identify what the purpose of a logger is for and why two devices are needed.
Back in chapter 4, Strive For Five said that you need a minimum of two devices to monitor your fridge. There is a need to have multiple INDEPENDENT devices that are checking the vaccine temperatures.
What this clause potentially did, was to say it is OK to use the vaccine fridges in-built logger.
The problem is that this is the temperature that the fridge is trying to control, as well as the temperature that is shown on the front (i.e. the min/max thermometer) and logged. There is no independent check that the fridge is actually working correctly. This totally undermines the purpose of having multiple devices.
There should have been a clause that says that the min/max temperatures displayed on the fridge should be from a different sensor than the one controlling the temperature, and that the logger is from another sensor as well. Personally I think the logger should be totally independent with no shared power, data or electronics.
And now a hugely controversial statement:
Note: There is a potential for equipment failure of automated temperature recorders (eg data loggers and remote monitoring systems); therefor, minimum and maximum temperatures must still be recorded twice daily as a quality assurance measure. Twice-daily and maximum temperatures must be manually recorded as a timely alert to any breach in the cold chain.
Issue 16: Why is this actually here and what does it mean?
This note is in the middle of a list of options for the vaccine fridge. It is tucked between castors for moving the fridge, and a glass door. Half a page earlier it did have the data logger quote above, but this is just tacked on in the middle of nowhere. It has nothing to do with the fridge, but with the procedures. It also leads to ambiguity as to what it is referring to.
The problem is, when Strive For Five actually talked about needing to do the twice daily check (sections 4.2 and 4.7), it was totally silent about needing the twice daily check for a automated temperature monitoring system (4.6). In this clause, however, it says “remote monitoring systems”. Does this include a fully automated system, and if so, why wasn’t the clause put in section 4.6?
Systems like Clever Logger will notify you if there is any problem retrieving results from your logger. This gives you the opportunity to either fix the problem or revert to manual checking. By this stage, the following would have to occur for a user to dispense compromised vaccines:
1. the remote monitoring failed to work, and
2. the user ignored the warnings from the system, and
3. the fridge became too warm because of some problem, and
4. the user ignored the beeping alarm on the vaccine fridge, and
5. the user did not look at the temperature of the fridge when removing stock.
Strive For Five then has a really interesting answer to why a twice daily check is needed in the Q+A section (page 81):
If I have a data logger, why do I need to record the minimum/maximum temperatures twice a day on a graph or in a logbook?
Some purpose-built vaccine refrigerators require data download from a data logger twice daily, but most facilities only download the data from the data logger once a week. Check with your state or territory health department if you are unsure what is required. Twice-daily temperature recordings ensure that any temperature deviations outside the recommended range are captured in real time to ensure that vaccines have not been subjected to a cold chain breach before they are administered. If you download and check the data twice daily, and keep these data, you do not need a separate recording chart. However, a record of who checked the minimum/maximum temperatures and the time they were checked should be kept for each refrigerator. The minimum/maximum display should also be checked visually every time before removing vaccines.
Issue 17: That’s back to talking about traditional loggers
The very question that answers why a twice daily min/max check is required talks specifically about retrieving the log weekly. It even says that if the log is downloaded twice a day then the manual check is not required. This is talking about traditional loggers again. Strive For Five does not have any instructions on what needs to happen when there is a fully automated system.
In regards to inconsistencies, the checklist on page 99 does not have the exemption for the twice daily download of the logger.
And just because I am on a total rant about why Strive For Five is such a poor document, this Q+A (page 84) highlights their lack of internal consistency:
I have a purpose-built vaccine refrigerator. How do I know what the maximum temperature is when there is no power?
A portable minimum/maximum digital thermometer can be used to monitor the temperature of the refrigerator when it does not have a battery back-up for the inbuilt temperature-monitoring system.
Issue 18: A minimum of 2 devices is required, one of which is a basic temperature logger. Why isn’t the logger used?
A “inbuilt temperature-monitoring system” is not a data logger. A data logger is designed to answer this question.
Strive For Five was a poorly reformatted document that attempted to update the previous version by simply neglecting modern technology. It has left the industry stalled in the dark ages until the next revision is written.
It has no idea what to do with a wireless temperature logger.
It has only a vague idea as to what a thermometer is, and it probably isn’t what is built into the vaccine fridge, but everyone assumes it is.
Could we do better?
Absolutely.
Can we volunteer for the committee for the next revision?
Clever Logger is sold to government departments, public and private hospitals, and other large corporations. We understand that it’s often not possible to purchase with a credit card on a web site.
Call us on 1300 80 88 89 or send an email to [email protected] and we’ll send you a written quote. We are happy to send out most orders on receipt of a verified purchase order.
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Clever Logger loggers are intended for commercial use only. They contain small batteries. Swallowing can lead to chemical burns, perforation of soft tissue, and death. Severe burns can occur within 2 hours of ingestion. Seek medical attention immediately.
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