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We received our CAP pre-inspection packet recently (version 06.04.2020) and I have a question.  TRM.42750 states "All component storage units are equipped with an alarm system that is monitored 24 hours/day (in laboratory or remote) with alarm checks (for both low and high settings) performed according to the manufacturer's recommended intervals, or at least quarterly if not specified, with results recorded."  Under notes it states  "The laboratory must demonstrate that all components of the alarm setting (including chart/graph recordings) work as expected and that there is a process to ensure a timely response to alarms, including remote alarms.  When facilities perform alarm checks, the temperature at which the alarm sounds must be compared to the temperature on the recording chart/log.  Examples of recording systems include:  Paper chart records, paper graphs, electronic records, even logs."  My question is we have a continuous monitoring system called Isensix but when I do alarm checks I utilize the alarm tests built into the equipment.  For example on our Helmer's with i.C3 APPS, Temp alarm test and in our freezers there's a specific alarm test that simulates the warm alarm.  Is this CAP standard now stating that we are required to perform an alarm check using hot and ice water baths just so our Isensix alarm goes off and I can document it's a test?  

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I know when CAP revived the standard, I was upset because I also thought I had to revert back to ice and water to make the chart move on my Helmer fridges and PLT incubator during alarm checks. That was moving backward as far as i was concerned.

I called Helmer and finally received a PDF regarding Helmer and TRM.42750. I was also sending email questions to CAP at the same time. Our equipment is older and doesn't have printouts but CAP stated a photo of when the alarm sounded should be OK to proof. (I am keeping that email for a future inspection, just in case.) I take a photo of the electronic screen showing the temp at which the alarm sounded and add to my Alarm Check QC sheets. 

I can't answer the part about Isenix so you probably need to contact CAP about that part but I have attached what I have from Helmer if that would be a help to you or anyone else. If you can't open the attachment, let me know and I will email it to you.

202001 TRM.42750 Helmer Solution for Alarm Checks.pdf

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Your remote monitor should document when an alarm sounds (along w the temperature that initiated the alarm).   If it does that you should be all set.  Do you routinely review your temperature documentation?  I've worked in places where the facilities folks monitored such - doesn't cut it in my opinion unless they are on top of those situations w good documentation.

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David Saikin - I'm in charge of the Isensix monitoring system for the entire lab, histology, and microbiology so I review logs at least weekly plus get paged for every every 2nd level and 3rd level alarm (email for 1st level).  Staff know if they don't respond, even in the middle of the night, I will call them.  Plus our hospital made it a requirement for Joint Commission readiness to have a report of all alarms and accordance to responding to the alarms so I have to look at it at least monthly.  

 

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Sonya Martinez- You are welcome! I was horrified that we had to revert back to messy ice and thermometers when we paid extra for the Helmer alarm system.

If you figure out how to "map" a fridge, please share with the rest of us. I would guess sticking thermometers all over to see where the warm spots are located but who knows. 

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On 10/2/2020 at 8:06 AM, DebbieL said:

Sonya Martinez- You are welcome! I was horrified that we had to revert back to messy ice and thermometers when we paid extra for the Helmer alarm system.

If you figure out how to "map" a fridge, please share with the rest of us. I would guess sticking thermometers all over to see where the warm spots are located but who knows. 

I Googled it and found procedures for pharmaceutical industry use that were very detailed/rigid that would require me to monitor 9 locations in my two door fridge and 5 in my one door fridge.  I discussed this with someone who is familiar with this sort of  thing. He suggested that it would be adequate to monitor 4 temp points in a two door blood storage refrigerator - top left rear, bottom left front, top right front, bottom right rear. He feels that I can use historical data to document that the refrigerators in use have been monitored and are operating within appropriate limits. I have checked multiple temps/multiple locations and documented that after installation of the units (years ago) and after repairs so I can prove that the temps have been consistent throughout the life of the units. I can state that I have been monitoring multiple temps ( two bottles and two built in probes) in different locations in the refrigerator daily (top, bottom and center) and historically those temps have matched + 1 C daily as specified by SOP.

Going forward, we will need to map after repairs and when replacing refrigerators. I think I'll go ahead and do that now when I get a chance just to see what the data looks like. I will use inexpensive data loggers so I can collect multiple data points over multiple days. Once that is complete I will know where to best place the thermometer bottles I'm currently using (two of them) to make sure they are in the hot and cold spots. I needed a new project - nothing better to do :no:.

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On 9/29/2020 at 8:58 AM, Sonya Martinez said:

 

 

On 9/25/2020 at 8:45 AM, DebbieL said:

I know when CAP revived the standard, I was upset because I also thought I had to revert back to ice and water to make the chart move on my Helmer fridges and PLT incubator during alarm checks. That was moving backward as far as i was concerned.

I called Helmer and finally received a PDF regarding Helmer and TRM.42750. I was also sending email questions to CAP at the same time. Our equipment is older and doesn't have printouts but CAP stated a photo of when the alarm sounded should be OK to proof. (I am keeping that email for a future inspection, just in case.) I take a photo of the electronic screen showing the temp at which the alarm sounded and add to my Alarm Check QC sheets. 

 

202001 TRM.42750 Helmer Solution for Alarm Checks.pdf 2.22 MB · 65 downloads

Bless you for sharing!!!

Edited by AMcCord
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