Does Clever Logger meet vaccine logging guidelines?

There is a lot of confusion amongst pharmacies and medical centres about what is required to comply with logging guidelines. How does Clever Logger measure up?
Does CleverLogger meet vaccine logging guidelines strive for five

Are the Strive For 5 guidelines relevant to Clever Logger?

On page 22, the Strive For 5 guidelines say …

This passage recognises that the functionality built into modern loggers such as Clever Logger will replace many of the Guide’s requirements for manual logging. 

Strive for 5 does mention wireless loggers:

 

Just as we find a section specifically related to Clever Logger it immediately puts us in the “too hard basket” and tells you to contact your state or territory health department for further information. Good luck! We haven’t been able to.

Instead, we are writing this article to show how we far exceed the requirements of Strive For 5, and provide some recommendations at the end for what the new standard could be.

Let's look at the intent of Strive for 5

At Clever Logger, we focus on the intent of the Guide, which is to provide a system that guarantees vaccine safety for the general public.

All you need to know is …

Clever Logger totally blows the Strive for 5 requirements out of the water!

To understand why, let’s look at the intent of the Strive For 5 guidelines.

Checking the min-max twice a day

On page 22, Strive For 5 says …

The intent of this guideline is clear – to get a “timely alert“. You want staff to know as soon as possible when a fridge fails. 

Unfortunately too much emphasis has been placed on the “twice daily” thinking that this is the need, but the real need is to know when a problem has occurred as soon as possible. 

Twice a day was a compromise between patient safety and the efficient use of staff’s time. A decision was made decades ago that it was an acceptable risk to have up to half a day between checks. 

If a company decided to check it 3 times a day, would it comply with this clause? Absolutely. 

Does Clever Logger record the temperature twice a day?

Twice a day? Pffft! Clever Logger checks the temperature 12 times an hour!

Clever Logger will send a notification to the user’s email and smartphone within minutes of a breach. This is clearly more timely that a twice a day check.

Now there is absolutely no compromise between patient safety and the use of staff’s time.

Downloading the data every week

The intent here is to have a permanent record of temperature data. It is not intended to pick up breaches, but just to ensure that you have the records. The requirement to do this weekly is because of the limited data storage in the logger’s memory.

The intent is NOT to look at a report each week.  The intent is to ensure that the data is there and that the logger is working.

Clever Logger blows this one out of the water too.

Clever Logger downloads the data to our secure server every five minutes. An unlimited amount of data can be stored on our server. A PDF or Excel data report is also automatically emailed to the user. These reports can be printed or stored electronically.

At any time, historical data (right down to the actual temperature reading in a five minute period) can be viewed and a PDF or Excel report on a specific period can be created.

More importantly, if there is any problem with the logger then you will be notified immediately. If the battery dies, you will be notified. Actually, you will be notified in advance when the battery starts to get low!!! If the gateway is turned off, you will be notified. If the internet is down, you will be notified. 

You don’t have to wait until the end of the week to discover you had a problem 5 days ago.

Visibility of the logger

The guideline says …

The intent is for staff to be able to check the temperature at any time.

So placing it where it is easily seen is great, if you’re near the fridge.

Clever Logger can show you the temperature of the fridge on your phone no matter where you are in the building. Did I say the building? I meant the world.

Sounding the alarm

The guideline says …

The intent here is, once again, to make sure that temperature breaches are picked up quickly. Most traditional loggers signify there is a problem by making a small red light flash. This is useful for people who are looking directly at the Logger and not much use for anyone else.

Clever Logger alerts users by sending notifications to email and the smartphone app. No matter where the user is, they can get the alarm, hopefully in time to do something about it.

Calibrate the Loggers every year

The temperature sensor in a Clever Logger is digital and does not need regular calibration.

Read more about calibration.

But we realise that peace of mind is best achieved by that independent check, and that’s why we offer an annual swap service. We will have a logger NATA certified and then sent to you. You then return the old logger to us. That way you will never be without a logger, and it will always have a current NATA certificate.

Once again, let’s blow the Strive For 5 requirements out of the water.

What do I have to do every day?

What I am writing here is totally my opinion. Unfortunately the answer to this question is not determined by me, but who ever will be auditing your site.

My answer is “nothing”. 

Here is my reasoning:

1. The vaccine fridge will tell you if it is too hot or cold by beeping at you

2. Clever Logger will tell you if the fridge is too hot or cold by beeping at you

3. Clever Logger will tell you if the power if off etc

4. Your staff should look at the fridge temperature EVERY time they use the fridge, not just twice a day. It should be ingrained in ALL staff, not just one person.

5. If we send you a report twice a day, people will just start to ignore all emails from us, including the alerts.

6. If someone has to log into our system to check it twice a day then we have just become part of the problem, not the solution.  The problem is that people are too busy to take notice of what is actually important. What is important is that patients get the right meds or vaccines, and that they will do the job. 

Are all wireless systems the same?

Most of the wireless systems that are on the market are probably really good solutions and we would endorse most of them. Hopefully we are easier to use and less expensive and you will choose us, but my goal with this post is to encourage the use of wireless systems, not just Clever Logger.

If you are considering another wireless system to monitor vaccines, these are the features that I think are mandatory (and Clever Logger does all of this, of course):

1. Repeating alarms: It is too easy to miss a single email or notification. The system needs to continually remind you until the fridge is fixed. This repeating alarm needs to be at least once a day. Many of our customers have a half hourly reminder.

2. Multiple notification options: You need to be notified in multiple ways. An email is mandatory and the best way to alert those who need to know about an issue, but to get a fast response it needs to go to a phone. SMS or phone notifications ensure that the person who needs to respond to an issue is told about it quickly.

3. Offline alarms: You need to know when a logger is not available. This could be because of a dead battery, being too far away, power failure or internet failure. It doesn’t matter why it is offline, but you need to know when it is so that you can fix the problem quickly.

These are some features that are important to some of our customers. I’m not putting them in the mandatory category, but these are pretty nifty ideas:

1. Escalation: Have the option to alert more people if it isn’t responded to within a time frame.  This could be another department, security (especially in hospitals), senior management, the doctors etc. 

2. User permissions: You want to allow some users to just see what is going on, while others can administer the system. Some of our larger customers also want departments or sites to see their own fridges, but not others. 

3. UPS powered: “Uninterruptible power supplies” (UPS) are battery backups to mains power. By having your modem and gateway plugged into a UPS, you can continue to have live data even when there is a local blackout. You don’t need a big, expensive one. Many sites already have a UPS for their server so adding the gateway to it is quick and easy. 

Other Strive For 5 Rants...

Now to burn my bridges…

Strive For 5 was a great document when it was originally written 2 decades ago. I was there for the launch. It was a great response to an industry that was dominated with dodgy domestic fridges.

Twice daily checks were needed because the temperature could easily drift by someone knocking the thermostat. These were also the thermostats that had a varying thickness line.

Now we have vaccine fridges as standard. Vaccine fridges are expensive, but awesome. They gave us the following benefits:

1. computer controlled on and off temperatures: domestic fridges had a controllable “on” position but not “off” – and notice that I said “position” and not “temperature”. Vaccine fridges turn on and off at specific temperatures. That is most of the problem solved just by doing that.

2. audible alarm: If something does go wrong, the fridge will make a noise. It won’t wait for a staff member to do a twice daily check. It will get their attention immediately.

3. temperature display on the outside: The staff just have to walk past to see what is going on with the fridge. There isn’t a thermometer hidden in the fridge that they need to hunt for.

4. fan forced: The temperature within a fridge is now much more uniform. In domestic fridges there is a huge temperature variation from top to bottom and front to back. 

(Yes, many domestic fridges now have many of these features. As the old proverb goes “What’s good for the vaccine is good for the lettuce.”) 

5. alarm relay: This allows the vaccine fridge to be connected to your alarm system. Most customers don’t use this and that’s a pity. This is possibly the best protection you have for overnight alerts. Keep in mind, this will still only tell you that there is a problem. Clever Logger then allows you to immediately login to see what is happening. 

6. glass door: This allows staff to see what they are after before opening the door. It is a great way to maintain the internal temperature. Be careful, though, because they do heat up faster in the event of a power failure.

 

What I am saying is that the vaccine fridge is now the most reliable thing on site, not your staff. And then there is Clever Logger watching your fridge 24/7. It is the second really, really reliable thing that is watching over your vaccines. 

And then in third place are your wonderful staff. They are great at doing their job but they are only there for 8 hours, and most of that is focused on customers / patients / paperwork / Facebook. As wonderful as your staff are, they are now the least reliable part of the equation.

Yet Strive For 5 is still fundamentally focused on staff doing the twice daily check to make sure everything is fine. 

 

And next rant, a fanatical fixation on 2° and 8°.  Yes, vaccines are really sensitive to 0°C and that is critical, but 2° and 8° were seen as safe boundaries. Go to any vaccine manufacturer and ask what happens if the vaccine reaches 12° for half a day. Instead Strive For 5 allows a 15 minute excursion and then … bam. 

The reason I hate this tight time frame is because it is totally overreactive, but it also means that staff have no opportunity to fix the problem afterhours. It really undermines our ability to help.

Of course Clever Logger complies. We are simply the bearer of bad news.

 

And last rant, the expectation that a logger be within a degree of the displayed temperature. There are many valid reasons why this is not the case. I can throw around terms like thermal latency, accuracy variations, and heat maps. 

There are simple techniques that can be used to alter the result (like move the logger) to make them comply. Some of the techniques are a bit under handed. I would rather have Strive For 5 require that both the fridge AND the logger be between 2° and 8° and leave it at that. 

But that’s a totally different debate.

 

Which means I will now stop my Strive For 5 rant. It’s a great document that cleaned up the industry. It’s just a tad out of date and we

BLOW IT OUT OF THE WATER. 

 

 

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