CAP regulation? -mandatory audible alarm on blood bank refrigerators?

[LIMPER55]

Would you cite the CAP standard that requires an audible alarm for blood bank refrigerators?

 

thanks!

[David Saikin]

What standard?  TRM.42750 only states that the alarm system has to be monitored 24hrs/day.  Says nothing about audible alarms.  But you do have to show that it works and there is a timely response.

[LIMPER55]

Thanks, David.

 Our old refrigerator's audible alarms cannot be fixed.

We are going to rely on security to call us.  

[David Saikin]

You had better validate that they can do so before your temps are out of range.

[tbostock]

Thanks, David.

 Our old refrigerator's audible alarms cannot be fixed.

We are going to rely on security to call us.

Here's the Joint Commission regulation; says the alarms must be audible. Time to get a new refrig.

QSA.05.04.03 : The laboratory uses alarm systems for refrigerators and freezers to monitor storage temperatures for blood and blood components.

Program: Laboratory

Chapter: Quality System Assessment for Nonwaived Testing

Rationale: N/A

Elements of Performance:

1. The laboratory has alarm systems for each refrigerator or freezer that meet the following requirements: - Alarms are audible. - Remote alarms are present for use when staff are not in the immediate area. - Alarms, including remote alarms, are monitored continuously. - The alarm system is battery operated or powered by a different circuit than the refrigerator(s) and freezer(s).

2. The laboratory has written policies and procedures for responding to the activation of the blood-storage alarm for refrigerators and freezers.

3. Policies and procedures for responding to the activation of the blood-storage alarm for refrigerators and freezers include the following: - A list of staff to notify, in order of priority - Backup or alternative provisions for blood storage - A process for maintaining records

4. The laboratory makes available to blood bank staff its policies and procedures for responding to the activation of the blood-storage alarm for refrigerators and freezers.

5. The laboratory follows its policies and procedures for responding to the activation of the blood-storage alarm for refrigerators and freezers.

[David Saikin]

I like that Terri - good thing I'm not with the Joint (though my alarms are all audible and monitored 24/7).

[LIMPER55]

Thank you, Terri

 I have forwarded this information to the director.

[David Saikin]

What standard?  TRM.42750 only states that the alarm system has to be monitored 24hrs/day.  Says nothing about audible alarms.  But you do have to show that it works and there is a timely response.

 interestingly the AABB standards also do not specifically state that the alarm needs to be audible

[mollyredone]

David,

When I read TRM.42750, it states "Is there an audible alarm for each component storage unit, is it continuously monitored 24 hours per day (in laboratory or remote) and has the response system to an alarm been validated?"

So, according to this, Yes, I would cite, unless there is a remote system in place, like Isensix, that has a responder to its audible alarm. Limper55 states that they rely on security to call them, so there must be a remote system in place.

[goodchild]

The phone call from security would be audible? As long as that was part of their alarm activation validations, it seems reasonable.

[David Saikin]

David,

When I read TRM.42750, it states "Is there an audible alarm for each component storage unit, is it continuously monitored 24 hours per day (in laboratory or remote) and has the response system to an alarm been validated?"

So, according to this, Yes, I would cite, unless there is a remote system in place, like Isensix, that has a responder to its audible alarm. Limper55 states that they rely on security to call them, so there must be a remote system in place.

Molly

quoting the July, 2015 changes to the standards (yes my inspection is soon):

 

"All component storage units are equipped with an alarm system that is monitored 24 hrs/day (in lab or remote), with alarm checks (for both low and high settings) performed and recorded at least quarterly.

Note:  the laboratory should be able to demonstrate how the alarm system works and that there is a process to ensure a timely response to an alarm, including remote alarms."

 

No mention of audible at all . . .  what version are you quoting from?   I don't do a low check on my freezer.

 

Like I tell the docs - I just report the data.

Edited September 4, 2015 by David Saikin

[mollyredone]

David, you are right. I was looking at an older checklist. That seems strange that they took that out. And I don't do a low alarm on FFP freezer either.