Brenda K Hutson Posted October 19, 2009 Share Posted October 19, 2009 I raised this question in a previous Thread but just got an "official" response from CAP (and by official, I don't mean a Tech. from another Hospital who performed our CAP Inspection). The CAP person I spoke to stated that "each" cooler should be validated, not just "1 of each type." I know the responses on this were varied so I just thought I would pass on the expectation of CAP (at least as I was told). I originally posted it because staff where I have worked for 22 months were telling me I only needed to do 1; however, in other jobs, I have always validated all of them. I would think there is always the potential for the insulation on any given cooler to be problematic. Anyway, just FYI. Brenda Hutson, CLS(ASCP)SBB Link to comment Share on other sites More sharing options...
kate murphy Posted October 20, 2009 Share Posted October 20, 2009 By that logic, we should be "validating" every single piece of everything we use - boxes that our blood comes in, every single bottle of reagent, every nuance of our computer systems for every possible combination of every single variable.....there is always the potential that one piece of anything is not the same as all the other pieces.I'm all for validating systems and processes, but I think this is getting over the top! Link to comment Share on other sites More sharing options...
Brenda K Hutson Posted October 20, 2009 Author Share Posted October 20, 2009 By that logic, we should be "validating" every single piece of everything we use - boxes that our blood comes in, every single bottle of reagent, every nuance of our computer systems for every possible combination of every single variable.....there is always the potential that one piece of anything is not the same as all the other pieces.I'm all for validating systems and processes, but I think this is getting over the top!Ok; just don't shoot the messenger...Brenda Link to comment Share on other sites More sharing options...
L106 Posted October 20, 2009 Share Posted October 20, 2009 Oh, I believe that "validating every cooler" would be FDA's stand. I don't know how extensively our blood supplier validates their shipping boxes, but we do validate every bottle of reagent and as many nuances of a new computer system that we can think of. Also, we do daily, monthly, and quarterly temperature and alarm checks on every blood refrigerator and freezer (even though we have several of the same model.)Don't get me wrong......I hate the ever-increasing nit-picking rules and regulations and policies and procedures we have to deal with, but I can imagine a particular cooler getting a crack and not holding the proper temperature.Donna Link to comment Share on other sites More sharing options...
kate murphy Posted October 21, 2009 Share Posted October 21, 2009 What you describe is QC, not validation. Yes, we do QC and inspections on our coolers on a quarterly basis, under normal operating conditions. When we do validation, we test extreme conditions, hot/cold, long term - stress the system, so to speak.On reagents, we validate a reagent from a certain vendor, but we QC it daily in use.I know the pendulum is swinging once again to more nit-picking rules - hopefully common sense will prevail! Link to comment Share on other sites More sharing options...
L106 Posted October 21, 2009 Share Posted October 21, 2009 Kate -You are right....I now realize that I was using the terms "validation" and "QC" inappropriately. (My bad!) You are correct about that. (Sorry.)However, I still think it is a good idea (and FDA's intention) that each cooler be validated before use.Donna Link to comment Share on other sites More sharing options...
dlo Posted October 23, 2009 Share Posted October 23, 2009 I raised this question in a previous Thread but just got an "official" response from CAP (and by official, I don't mean a Tech. from another Hospital who performed our CAP Inspection). The CAP person I spoke to stated that "each" cooler should be validated, not just "1 of each type."I know the responses on this were varied so I just thought I would pass on the expectation of CAP (at least as I was told). I originally posted it because staff where I have worked for 22 months were telling me I only needed to do 1; however, in other jobs, I have always validated all of them. I would think there is always the potential for the insulation on any given cooler to be problematic.Anyway, just FYI. Brenda Hutson, CLS(ASCP)SBBWill one time validation of the cooler enough? Do we need to periodically verify, check, monitor the cooler performance? Link to comment Share on other sites More sharing options...
Likewine99 Posted October 24, 2009 Share Posted October 24, 2009 We validate our once a year. Link to comment Share on other sites More sharing options...
mbk0128 Posted October 25, 2009 Share Posted October 25, 2009 Would anyone be willing to share their cooler validation procedure? Thanks Link to comment Share on other sites More sharing options...
Likewine99 Posted October 25, 2009 Share Posted October 25, 2009 I have one if anyone would like to e-mail me at work I'd be happy to shareMary_Mendel@ssmhc.com Link to comment Share on other sites More sharing options...
clmergen Posted October 26, 2009 Share Posted October 26, 2009 Everytime I use a cooler and the units come back with an acceptable temp an informal validation that the cooler works is completed. With 20 coolers on the shelf, it would take me a month to validate all of those. I buy the exact same type and validate under 2 conditions, the ice from my machine and the ice from our ED lab that issues uncrossmatched blood. I will wait for an actual writeup before I validate 20 coolers every year. We do a quarterly inspection and clean every time it is used. Cracks and other cooler faults would be discovered well before annual cooler validation. And I have documented proof that they are found. Link to comment Share on other sites More sharing options...
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