Open Forum

Hi everyone, an interesting situation has come up and I need your help for data and evidence to make some informed decisions.  Best practices count. 

• The situation is the storage of CLIA waived controls.  Many require refrigeration when not in use.  We do that and comply with the temp ranges. 
• However, there seems to be no data on what happens if the refrigerator gets too cold (or too warm) and is out of range. 
• We have commercial grade refrigerators and keep and monitor a thermometer in each unit. 
• However, the thermometer is not a digital data logger (DDL) electronically connected to constant monitoring (like our vaccine storage freezers and refrigerators). 
• We monitor Monday through Friday and would not pick up a temp excursion on the weekend.
• When there is a suspect or confirmed temp excursion of an unknown duration of time - even if the control line indicates a valid result - manufacturers are silent on this in their IFUs (no data, since none is required by the FDA) and thus state "when in doubt, throw it out". 
• It's getting expensive.    
• Of course, when you ask the manufacturer and have some uncertainty – as we all do every weekend when we are not monitoring refrigerators -  or identify a temperature excursion of unknown duration -

1. what are you doing for CLIA waived storage for controls that require refrigeration?  
2. Is anyone using a DDL for refrigeration storage for specimen and CLIA waived controls?
3. Can you store controls in the same refrigerator as vaccines? (in the past TJC said no, but I can't seem to find the reference). 

I sent this out to our APIC community for a response also.  Please let us know what you are doing.

In my ongoing search I did find a Q&A on the TJC site that states that meds cannot be stored in the same refrigerator as reagents and specimens.  However to check with our Board of Pharmacy. A 

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Andrea Lombard BSN RN MPH CIC
Community Health Services
Windsor CT
(860)716-4885
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Hi all, I noticed that some of my question was cut off.  When we call the manufacturer and we dont have specific info about how long a control/reagent is out of temp, they tell us to discard it.  But here's the catch, since there is no data or information even with adding the expense of a DDL we would most likely be instructed to discard the reagents also.