Posted January 23Jan 23 comment_92388 Maybe I'm crazy (likely), but I don't see high/low temp alarm checks in AABB or JC standards.. Is this only a CAP thing? Still adjusting to the move away from CAP and trying to determine what is and isn't required now. AABB only has settings checks. JC has records checks of alarms taking place and the response to them. Am I missing something here?
January 23Jan 23 Solution comment_92389 We were on the Rees system, a very large facility. They tested on a single probe a year for their high / low check as they said it was the computer that was making the decision to alarm or not. They calibrated each probe. We took all charts off and stopped doing any alarm checks probably 20+ years ago. If a Rees probe or the whole system went down, we had validated thermometers in each fridge, and we'd put a chart on it. We knew we could not rely on the chart, but we would use it in the case of a significant temperature excursion. Maybe the O Pos fridge went a little wonky. We'd review it with the Medical Director and then decide what to do with the products. We never had an issue with AABB or TJC. We were not CAP accredited. When I started as a new tech right out of school, we did not have the Rees system. We had a coop student who would take temps manually once a shift and change all the charts weekly. We did monthly alarm checks - that could take several days. The Rees system had about 100 inputs by the time I left. An automated alarm system is the way to go. We even put an O2 sensor near our LN2 tank.
January 23Jan 23 Author comment_92390 Perfect! We are currently on Rees as well. We have a fridge that recommends quarterly alarm checks but that is being replaced soon and that would be the last shred of alarm check suggestion that I see. It is hard to let go of the CAP overlord since JC is so streamlined and often vague. I appreciate your anecdote!
January 24Jan 24 comment_92410 AABB Standard 3.5 looks the closest to what you're looking for: The BB/TS shall have a process for scheduled monitoring and maintenance of equipment that at a minimum is in accordance with manufacturer's written instructions. The AABB Technical Manual has recommended maintenance frequencies, but that clearly states "recommended". I do know that AABB has just put out a request for input on the 35th Ed. of Standards, and it was already brought up that quarterly alarm checks need to be gotten rid of, so I know they will be looking at that closely. Though, upon looking for where it states quarterly checks are needed, I agree with Randi that I can't find that anywhere.....and I feel dumb for continuing to have done quarterly checks.....I've only got 10 fridges/freezers though, so it's not as burdensome as larger blood collection centers! Would love to hear what others have to say on this!
February 3Feb 3 Author comment_92595 This was the clarification I got from AABB... so looks like at least one high/low check of the monitoring system as a whole would be wise? Quote Here is the clarification to your request pertaining to Standard 3.9 - Alarm Systems, in the AABB Standards for Blood Banks and Transfusion Services, 34th Edition. Response (from the BB/TS Workgroup): Standard 3.9.1 requires that alarms be set to activate under conditions that will allow proper action to be taken before blood, blood components, tissue, derivatives, or reagents reach unacceptable conditions. To ensure your facility is meeting this requirement your alarm testing should verify that alarms are activating when the temperature in storage units is moving towards unacceptable temperatures, either too high or too low. It is important to ensure the alarms activate before the temperature in the storage unit becomes unacceptable so that you have sufficient time to move products to an appropriate alternate storage unit. This would necessitate testing of both high and low temperature alarms and documenting that alarms have been triggered at the appropriate temperatures as described in your procedures. Standard 3.9 Alarm Systems is also annotated with a pen symbol (!) which means users have to maintain a record of the activity in order to meet the AABB BB/TS Standards. I sincerely appreciate your patience and understanding throughout this process. Best Regards, Jason
May 15May 15 comment_94329 On 1/23/2025 at 11:20 AM, RRay said: Maybe I'm crazy (likely), but I don't see high/low temp alarm checks in AABB or JC standards.. Is this only a CAP thing? Still adjusting to the move away from CAP and trying to determine what is and isn't required now. AABB only has settings checks. JC has records checks of alarms taking place and the response to them. Am I missing something here? It is required per CFR 493.1271 Standard: Immunohematology, see below. IMO, how the lab wants to do this would be up to them and the manufacturer's specifications Per CAP regs, if the manufacturer does not have a specification for frequency then the alarms must be testing quarterly. (c) Blood and blood products storage. Blood and blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (2) Inspections of the alarm system must be documented.
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