Could someone help me with the requirement for alarms on refrigerators. Our refrigerators have alarms and charts. If our Blood bank is staffed 24-7 do they need to be alarmed to an outside area( hospital Switch Board). I need regulation citations to show my supervisor.

I can find no standard that requires remote monitoring of temp alarms. Just that the temp needs to be maintained 24/7.

We used to have an alarm at the switchboard eons ago when we were not staffed 24/7. Once we started staffing round the clock, we pulled that alarm and no one has ever said a word. We used to be inspected by the FDA and they didn't say anything either.

 

The fun thing about the switchboard alarm was that every time we were inspected we were asked to trigger the alarm to see how long it took the switchboard to respond. We would do that and wait and wait, then wander down to the switchboard to see why no one was calling. You could hear the alarm before we got to the lobby. We would ask the operator why she hadn't called us....we got 2 answers - either she didn't know what the alarm was for or she knew we (the lab) were there, so she didn't respond. We educated every year, but it didn't stick. Needless to say, we got cited every time. That was a system we were glad to say goodbye to.

AABB Standard 3.7.3 is "Activation of the alarm shall initiate a process for immediate investigation and appropriate correctve action." Being staffed 24/7 would allow you to take immediate action.

**REVISED** 07/29/2013

TRM.42750 Storage Unit Alarms Phase II

All component storage units are equipped with an alarm system that is monitored 24

hours/day (in laboratory or remote), with documented alarm checks (for both low and high

settings) performed at least quarterly

Agreed. No need to alarm at the switchboard, who would only be calling you to tell you something you already know.

How about  night shift?  Is there always someone physically in the Blood Bank?  Or are the refrigerators/freezers situated so that the staff could hear the audible alarms go off?

Just had an issue happened today and I really don't want to waste these products. Our Blood Bank Refer and Freezer are monitored once  day with NIST certified thermometers. These thermometers also have a minimum high and minimum low display to announce the highest temp reached and lowest temp reached by the thermometer. In addition we have weekly charts, an alarm that goes off in our ER and we check daily, plus 24 hour staffing.

This morning the tech realized she did not tighten the screw to the recording chart well enough. Meaning we now have a temp taken yesterday and a temp taken today, which are both within range.  No alarms were activated, plus we  have a urine cup container inside the Freezer that has a penny Frozen on the top. This should indicate any thawing if the temperature gets too warm. That also was satisfactory. 

Help, can I save these units since I don't have continous monitoring recorded, but no indications of temp failure were noted?

This has happened a few times here when the chart has gotten stuck and we did not notice it until the next day, we would document on the chart that no alarms were heard during that period.

 

Also, our temps are remote recorded by Engineering.  They are able to go back up to a week on thier system and print us out a chart if we need one to cover any gaps on ours.

 

Scott

I looked up the CAP requirement TRM.42550: Storage Temperature Range Corrective Action- "If the proper storage temperature range is not maintained (inspector will check 4 weeks of recordings), there is evidence that timely corrective action has been taken, as well as documentation of the disposition of any affected components". I would say that I have enough evidence to say temperature was within range, but I don't have the continous charting or temps every 4 hours. I was worried about discarding units based on not having recordings at least every 4 hours. I feel it's like a pregnancy test, maintaining the temp range colder then -18 C is the qualitative ( In this case, the Freezer is pregnant). Knowing the actual temp is the quantitative (We don't know the specifics). Regardless, Freezer is pregnant = Temp range maintained. I will be printing a list of the inventory to attach to the variance. No need to discard units.

 

I hope you all agree.

I agree. Document the circumstances using your nonconforming event system and apply appropriate follow up.

Edited January 13, 201510 yr by goodchild

Once again, I agree with goodchild.

I agree with goodchild - document  and all should be fine.