CAP requirement for alarm checks

[woebegone1997]

I'm the manager of a blood bank, new to the organization. I was surprised to find out that my department does an audible alarm check DAILY for refrigerators & freezers. I was told that this was a recently revised CAP requirement. Now, I came here from another laboratory organization that was also CAP and AABB certified, and I knew of no such requirement (just the quarterly alarm checks). I'm thinking that this was some individual auditor's over-zealous reading of the daily temperature check requirement (acceptable by either documenting a temperature or using a graph/chart, including a "graphical recording device"). According to my staff who were involved in the previous CAP inspection, the auditor demanded to know how we know if the audible alarm is working between the quarterly checks. My answer would have been that we comply with AABB and the manufacturer's requirement for quarterly checks. Does anybody have any similar experience with this issue, or clarification?

[SMILLER]

Perhaps a good answer may have been something like "we follow all manufacturer and regulatory requirements to ensure that the alarms work properly"?  Did you end up getting cited? 

We do alarm checks daily (I know: "and how do you know they work between daily checks...").  Like many Labs, we also have a remote monitor that pages an engineering associate if an alarm goes off.

Scott

[Malcolm Needs ☆]

51 minutes ago, SMILLER said:

Perhaps a good answer may have been something like "we follow all manufacturer and regulatory requirements to ensure that the alarms work properly"?  Did you end up getting cited? 

We do alarm checks daily (I know: "and how do you know they work between daily checks...").  Like many Labs, we also have a remote monitor that pages an engineering associate if an alarm goes off.

Scott

..............And how do you know if the pager breaks down at the same time as the remote monitor breaks down at the same time as the fridge breaks down!!!!!!!!!!!!!!!  Eventually, you have to trust a system, or send the inspector to the psychiatrist for assessment!

[goodchild]

If your technologists are hesitant from a previous inspection to change, contact the standards interpretation hotline for CAP, get a hard copy response, and you can put this to bed for good.

We were still doing that same process here (and for the same reason), until I came into this position and put an end to it.

[Dr. Pepper]

I have not looked at a CAP checklist since last summer (and may never do it again as Ibegone2016 at the end of the month), but it sounds like an overzealous inspector transposing his opinions into the CAP standards. Happens a lot. Follow Goodchild's advice.

[mollyredone]

Believe it or not, we were doing the same thing, until I was doing our self inspection and the CAP checklist just listed it as quarterly, as well as the manufacturer's recommendations.  So I took it off our daily maintenance.  So unless your equipment manual states that it has to be done daily (because CAP states you have to do manintenance as often as the manufacturer recommends it), quarterly is just fine!

 

 

[woebegone1997]

Thank you, everyone, for your responses. You have all corroborated my interpretation of the CAP requirement. I will be following up with CAP, as Quality Guy suggested. I will post with CAP's answer!

[woebegone1997]

I received the following reply from CAP:

Quote

 

TRM.42500, Blood/Component Storage Monitoring states in the second paragraph of the NOTE section that ther must be a written procedure for elavauating these systems as well as maintenance of temperature when power failures and other problems occur. One could argue that by checking the audible alarm on the refrigerators is one way of assuring that if there was a power outage, that the battery back up system is working as expected and product could be safetly transferred to another working refrigerator. The inspector who cited the laboratory was most likely thinking in those terms. As you are aware, the CAP checklist items do not always specify as to what a laboratory should do because it is the Blood Bank Medical Director's responsibility to assure that the blood products are safe at all times. Checking the audible alarm would be considered best practice, however I would recommend that you check your state, federal, and hospital regulations. For example, the Joint Commission has a standard, QSA.05.04.03 which reads: The laboratory has alarm systems for each refrigerator or freezer that meet the following requirements:

- Alarms are audible

 

In order to know that the alarms are audible, a daily audible alarm test would be in order.

 

Once again, I think that this is an over-reading of the TRM checklist, but we are keeping the procedure to test audible alarms daily. And of course we do have a written procedure to address TRM.42500. My point is that in TRM.42750 states only, "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."  (Emphasis mine.) We have refrigerators/freezers with alarm system boards, which do require daily checking, according to AABB Technical Manual (Appendix 1-3, 18th ed), and audible alarm checks are easy enough for these units. AABB also requires alarm activation checks only quarterly, and I don't know of any instance where CAP has more stringent requirements than AABB. 

We recently purchased units without the system boards, and these are not as easy to make alarm on demand. Depending on the unit, it can cost $1000-$2000 more to buy with system boards. Our CAP inspection is coming up any day, and I will ask the inspectors again, but unfortunately, I don't see us eliminating the daily audible alarm checks. And any future purchases of refrigerators/freezers will cost more! Please post in this thread if you have any encounters related to the topic.

 

[goodchild]

I don't know the exact set up for you but we were doing the daily checks every day in addition to our wireless network-based continuous temperature monitoring system.

For us, my response would be that if there was a power outage (in that particular outlet) we would lose signal on the continuous monitoring system and then investigate and followup. Or if the probe was still powered but fridge was down we would get the alert that the temperature was dropping at the expected range and the audible alarm would sound. If we had a network outage we would resort to manual temperatures according to our contingency procedure. And then there's the people who say that "it only takes a few minutes to do, it's not a big deal." And you end up with dozens of "not a big deal" things that eat into the workflow every single day and drive me crazy. We eliminated doing them last year.

End rant.