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Medical Forum / General / Laboratory / June 2005Microbiologists, question regarding API 20E QC
Our lab recently had a COLA accreditation survey. The surveyor said that QC of API 20E strips (using stock organisms) should be done WEEKLY. That didn't and doesn't sound right. I called Biomerieux and they indicated that once each lot number/shipment is sufficient. I asked for a reference, and the tech support person said it was found in NCCLS document M02-A8. When I read the description of that document, it sounds like it mainly pertains to susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they have yet to get back with me. Any ideas? Historically, our lab has been surveyed by CAP and JCAHO and most recently COLA. I've never heard of this as a deficiency before. We had been doing the QC monthly for years and this has never been a deficiency. > Our lab recently had a COLA accreditation survey. The surveyor said that QC > of API 20E strips (using stock organisms) should be done WEEKLY. That [quoted text clipped - 10 lines] > COLA. I've never heard of this as a deficiency before. We had been doing > the QC monthly for years and this has never been a deficiency. If you are CAP accredited, why do you need a second inspection by COLA? I've never heard of them?  SignatureK. Sprout the MungBean to reply "I don't like to commit myself about heaven and hell‹you see, I have friends in both places." --Mark Twain I've worked in clinical micro for nearly 30 years and I've never worked anywhere that QC'd API's weekly. The expense would be mind-boggling, as you have to have a positive and negative for every well. We QC upon receipt only. Same with Vitek GNI cards - upon receipt only. When I worked in a private lab we used Crystal ID as a backup ID system - again, upon receipt only, and we were also CAP accredited. Our pathologist there was, at one time, the head honcho at CAP, so we did everything exactly by the book. Is there some reason you're doing it monthly? I suppose if we had problems with the strips we would repeat QC in that case. We are a CAP accredited laboratory, and perform the micro work for four hospitals. Susceptibility testing is done on a weekly basis, both Kirby-Bauer and Vitek. Judy Dilworth, M.T. (ASCP) Microbiology "Lynn Gerber" <lgerber@cableone.net> wrote in message > Our lab recently had a COLA accreditation survey. The surveyor said that QC > of API 20E strips (using stock organisms) should be done WEEKLY. > Our lab recently had a COLA accreditation survey. The surveyor said > that QC of API 20E strips (using stock organisms) should be done [quoted text clipped - 5 lines] > I tried contacting NCCLS/CLSI via e-mail, but they have yet to get > back with me. Different accreditation and continent, but we don't QC them at all. Biomerieux are ISO certified for production and on request will supply QC certificates for each batch. If you QC where do you stop, positive and negative controls for each well? Even if you put a know Salmonella or E. coli through that won't prove that another strain or organism won't produce a wrong ID. Plus do you QC the reagents? Presumably you regularly use APIs for EQA samples and as long as these ID satisfactorily then this demonstates and on going suitability and as Biomerieux are certified to produce a consistant product that should be sufficient. Dave That would be nice to do, but CAP mandates QC on receipt. I think we QC reagents on receipt but I'm not sure. Our QC is spread out and different techs are responsible for different things as there's way too much for one person to handle. Judy Dilworth, M.T. (ASCP) Microbiology > Different accreditation and continent, but we don't QC them at all. > Biomerieux are ISO certified for production and on request will supply QC > certificates for each batch. > That would be nice to do, but CAP mandates QC on receipt. I've just had a very quick flick through the CAP manual "New lots of reagent must be checked against old lots, or with suitable reference material, before or concurrently with being placed into service." Has anyone tried arguing that where it says "before" could refer to the QC carried out by the manuafacturer? Dave Micro ID systems are just that - they are not "reagents". The requirements for comparing lot to lot refer to diagnostic tests that give verifiable numbers that can be compared using the 2 lots. The manufacturer's recommendation for ID QC is what pertains to micro. I even went to a lecture given by the micro QC person at CDC and he was trying to recommend setting up 2 controls - a saline blank for negative and a combination of organisms (a soup) that would give all positive results. All you are interested in is seeing that the kit is capable of giving the appropriate POS or NEG reaction, NOT that it can identify a QC organism. SignatureJohn Gentile MS M(ASCP) yjgent@cox.net Laboratory Information, QA Manager VA Medical Center Providence, RI The contents of this message are mine personally and do not reflect any position of the Government or VA. >> That would be nice to do, but CAP mandates QC on receipt. > [quoted text clipped - 8 lines] > > Dave > Micro ID systems are just that - they are not "reagents". The > requirements for comparing lot to lot refer to diagnostic tests that [quoted text clipped - 6 lines] > capable of giving the appropriate POS or NEG reaction, NOT that it can > identify a QC organism. The applicable requirement would to be to check with suitable reference material. As I said before what you'd need to do for an API to have any true meaning is positive and negative reactions for each well. Having an all pos soup wouldn't tell you for example if it was the Salmonella that gave you a positive ONPG. If you wanted to get really silly you'd have to QC each reagent separately from the test strip because if there was a unexpected reaction you wouldn't know if it were the reagent or the strip. You'd have to show that the mineral oil was sterile and didn't have any effect on the test etc etc. I can't see where it says the lab must do the testing just that it must be done before being placed into use. To me that could be the supplier's QC Dave Dave >> Micro ID systems are just that - they are not "reagents". The >> requirements for comparing lot to lot refer to diagnostic tests that [quoted text clipped - 25 lines] > > Dave Hi Dave A relevant point is whether or not the the manufactuirer of the kit is accredited to any Internatioanlly recognised standard such as the various ISO, UKAS local relevant systems. If so then given adhearance to the requirments of maintaing accredidation to such a scheme I see no need regulary run reagent checks or positive controls providing adequate QC certification has been provided by the manufacturer. If the alternate is true then you have no assurance of quality etc etc N10 >>> Micro ID systems are just that - they are not "reagents". The >>> requirements for comparing lot to lot refer to diagnostic tests that [quoted text clipped - 40 lines] > If the alternate is true then you have no assurance of quality etc > etc I've already said this, but apparently under CAP accreditation ISO means nothing and you still have to do in house checks. Dave >>>> Micro ID systems are just that - they are not "reagents". The >>>> requirements for comparing lot to lot refer to diagnostic tests that [quoted text clipped - 45 lines] > > Dave Hi Dave :} Im getting a strong sense of impending DOOM looming here, as the prospective work load in your lab plummets into an endless abyss of verification upon verification. I can offer no further help, only condolencies, for as you correctly state the accreditation Standard you seek to accquire does state that in house checks must be done as you describe. I guess if you want the acrreditation then you will have to comply with the standard. I guess yourr lucky you dobnt use 50 CHs lol Best N10 > Hi Dave :} > [quoted text clipped - 6 lines] > to comply with the standard. I guess yourr lucky you dobnt use 50 > CHs lol You're probably missing the whole thread. Luckily I've got nothing to do with this accreditation, I was just answering a question. UKAS don't seem so bad now ;-) Dave >> Hi Dave :} >> [quoted text clipped - 13 lines] > > Dave THAnks Dave My news reader is a bit patchy for some unknowable reason so I agree I probabley have missed quite alot of the thread, that often happens. Glad its all resolved and I agree UKAS are just dandy. Best Des > Our lab recently had a COLA accreditation survey. The surveyor said that QC > of API 20E strips (using stock organisms) should be done WEEKLY. That [quoted text clipped - 10 lines] > COLA. I've never heard of this as a deficiency before. We had been doing > the QC monthly for years and this has never been a deficiency. I would think that testing once each lot number was appropriate. Why arbitrarily weekly or monthly? Neither makes any sense to me. I suppose maybe they thought a month was too lax and somehow weekly would be better. At least lot testing is bounded in reality. > Our lab recently had a COLA accreditation survey. The surveyor said that QC > of API 20E strips (using stock organisms) should be done WEEKLY. That [quoted text clipped - 4 lines] > susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they > have yet to get back with me. The A2 NCCLS document only applies to sensitivity testing. QC of bundled kits is still recommended at once per lot. It sounds like the surveyor doesn't understand NCCLS or CAP. SignatureJohn Gentile Editor, Rhode Island Apple Group yjgent@cox.net RIAG Web page: www.wbwip.com/riag/ "I never make mistakes, I only have unexpected learning opportunities!" |
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