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Showing results for tags 'validation'.
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Hello, We are going to be moving forward with testing cord blood gases. We currently run venous gases and arterial gases on our ABL 800 series. Now since a cord gas is still technically a blood specimen, does this require a new set of validation? We are not running reference ranges with this, so I don't know if that would make a difference. Thanks for any input.
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Hello All, Now that Cerner has migrated from major release upgrades to incremental upgrades, how are you managing the Blood Bank validation effort? We have not yet received any guidance from Cerner and at this point we feel that we will need to make the determination to validate on our own. How are you some of you handling this? Thank you! Respectfully yours, Maureen Slackway, MS, MT(ASCP), CPHIMS, CQA, CAPM Senior Application Analyst – Laboratory Systems, Universal Health Services, Inc.
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Hello, One of our smaller sites uses a specimen rocker to keep platelets agitated before being transfused. They do not routinely stock platelets which is why purchasing a platelet incubator/agitator is not on the agenda. On our last accreditation inspection we were cited for not performing a validation of the rocker for platelet storage. Has anyone done a validation of this type and could you share the details of how to set this up? Thanks!
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Hi All, I am about to venture into performing my first ever validation of a test. I have been tasked to validate Rh+K phenotype testing on the BioRad IH-1000 (two of them). We have been, until now, performing the test manually, but as work is getting busier, performing it on the analyser might prove easier (or at least motivate people to perform phenotype). I have been given advise by my senior on how to go about it: Select 10 Donor Red Cell units which have Rh+K phenotype performed Perform the phenotype manually Perform the phenotype on the analyser compare the result pat myself on the back, provided I don't mess it up The issue I have is donor red cells doesn't indicate if they are K+, and I wanted some K+ as well as K-. I could always keep testing a lot of donor units until I come across a K+ unit, but I don't want to was a lot of cards (but that might be my last option). If I choose the NBS or BioRad Antibody Panel Cells, then the issue is the strength of the test cells, as they are, I think, 0.8%, and it does not fully represent the way we perform our phenotype manually, as it uses around 5%. I can always try and make the strength of the solution stronger, that is another option. So this is where I am at. If anyone has a suggestion, or better a complete plan, then I am happy to hear it. Also if there is any point I missed or need clarification, please feel free to ask, I'm fixed to this specific thread all night long. Cheers, Jermin
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We recently got a new freezer for the Blood Bank. I am performing my first validation. I am comparing the NIST against the digital display as well as the chart and our own, seperate thermometer. I cannot find any documentation to support how much difference is acceptable between the NIST and the digital read/our thermometer/ etc. Some places I have read say 0.5 degrees which seems very tight to me. Another facility I work for uses 1.0 degree difference which seems more acceptable and able to obtain but I have not found any supporting documentation anywhere! Can someone help me? When validating, what difference is acceptable between the NIST and the other thermometers, be it the probes in the unit or your own internal thermometers?
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I am switching from an Immucor antibody panel to a Quotient antibody panel and need to do a validation. Does anyone have any suggestions regarding this? How many samples (both pos and neg) I should use or know of any references I can look at?
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Hello Everyone, Need some guidance on validation of blood warmers. Recently our clinical engineering bought 24 new blood warmers, same model and brand of what we have already used and validated. We have just recently validated 6 of the 24 new ones with running blood through them and taking whole blood potassium levels at hourly intervals. The question we cannot agree on is do we need to validate every single blood warmer or is the 6 that we have done a sufficient sampling to be able to make a blanket statement that the warmers are ok for patient use. Anyone have any evidence based answers to this? At this point I'll take just some good advice! Thanks in advance.
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Hello everyone, We have just received the OrthoWorkstation to replace our ID-MTS. What kind of validation did you use? How many positive and negatives for parallel testing? Just trying to get an idea before I get started. The manual has no recommendations as to how to validate. Also, what kind of thermometers are you using for it? I know we are going to have to get a new one to fit inside one of the gel cards.
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Has anyone installed a new blood bank refrigerator recently? I know we need to do IQ, OQ, and PQ. Does anyone have plans that they have used successfully that you would be willing to share. Did you perform temperature mapping or have it performed by vendor or third party?
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Our facility is updating our floor model centrifuge which will product volume reduced platelets (Apheresis Platelet which is Plasma Reduced). I'm interested if anyone has validated this process in their facility, and if so...what product parameters did you use to ensure volume reduction yielded viable platelets? We will be performing IQ/OQ of the centrifuge but in planning for the PQ of the product, we are initially considering: - volume of product pre/post - platelet count in pre/post (or lack of platelet/reduction of platelets in the 'removed' portion...) - visual inspection of vol reduced platelet (i.e., the swirling of platelets) If you've recently done it, know of any good references or can share any good (or bad!) experiences, please do! I imagine it would be similar if you've recently validated washing platelets, too... Thanks - and happy 4th!
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For blood banks/transfusion services who issue Rhogam, do you know if there is any validation or change process required if I change manufacturers? Has anyone used HyperRho? If so, what do you think of it? Thanks!
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Does anybody know a company that preforms blood bank validation in Middle East? Any recomendation.