Cliff
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Everything posted by Cliff
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Hmm, interesting question. My answer is Yes, and No. :tongue: No - A cell is a cell. These machines are approved from FDA. Yes - I believe there can be some benefits to the recipient if they are to receive both products from the same donor, a way of limiting donor exposure. Also there can be a pretty big benefit to the donor, they only need to come in once every 16 weeks to do a double red, plus for the auto donor who is only going to do 2 total units, they can do it all in one visit. Very unscientific, just my thoughts.
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neonatal LRC aliquots in prefiltered syringes
Cliff replied to lwalton's topic in Transfusion Services
This sounds like straight forward aaBB Standards for product dating of open system products. Look at the chart in the back of Section 5.0, Reference Standard 5.1.8A. -
I'm not that familiar with all of the concerns, but isn't it possible to simply use an uncoated non-additive tube? I remember hearing that some of the clot activators had "glass" dust in them and it interfered with some microscopy work.
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Great topic, I think it needs to be a combination of your reagent as well as the tube. I am at home now and don't readily have any manufactures inserts, I'll have to work on that , but I found this on BD's site (not to promote any one company over another). It was from their FAQ section. Can the BD Vacutainer® Plus Plastic EDTA Tube be used for routine blood bank procedures? Yes, the BD Vacutainer® K2EDTA Plus Plastic Tube has received routine FDA clearance for red cell grouping, Rh typing, and antibody screening.
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Thanks guys, these ideas are great! And Kim, "cutesy" is OK too, so feel free to add them.
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Thanks Lu, The thought is to have a generic site that this forum will be a part of. You'd be surprised to find out how many site names are taken. We were interested in one name that someone owned but never had any plan to use. There have been many well publicized cases of this happening, I remember one related to Burger King. Someone registered the name before Burger King themselves did and wanted them to pay huge amounts of money for it. People who do this repulse me. If you have an honest product that you want to sell me I'll consider it, but there are some out there that simply register names and then hold them hostage. The last person I contacted said they had recently turned down an offer of $18,000 for the right to use the name. Keep in mind that it costs about $8 dollars to register a name. Slime! :mad:
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Laura, Would you be interested in sharing your SOP for this? We wash a fair amount of platelets with limited success.
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When we opened this site it had a completely different purpose, it was going to be a commercial product for tracking donor loss, hence the site name of “DonorLimitsâ€Â. Since that time we have decided to forgo that path and are considering several new ideas. With this new direction we no longer feel the site name is fitting. We’d love your help in coming up with a more “generic†name to describe a general blood banking site. We have been wracking our brains trying to find one we like and is an available site name. Feel free to contact us with any suggestions.
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No, at our hospital the NICU physicians order platelets by the ml. We usually add 15ml to their order.
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Hi Jane, This is how we supply platelets to babies, by dividing pheresis units. We do not have random platelets in inventory any longer. We label all of our platelets with the platelet count, you might want to consider the platelet count of the parent unit that will be left behind after you create the aliquot.
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Hi, We are in the process of installing Mediware’s HCLL and LifeTrak Lab / Donor. I know there are not many implementations of HCLL at this point. I am looking for information on how people have approached the process of system validation. We will be relying on the vendor quite a bit to provide validation scripts to us. We also have in our contract to have Mediware assist us with the overall validation process. At this point Mediware has not authorized any third party validators to work with HCLL. We have a very complicated conversion process. We are currently operating as two separate donor centers that have separate deferral systems yet share donors, so data conversion will be a challenge. Has anyone undertaken such a large project? If so, it would be great to hear from you.
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We too use the REES system. I contacted REES about this issue a while back, and they feel their temperature monitoring devices do not necessarily fit into the category of electronic thermometers. They are technically thermistors. We have close to 100 probes in several buildings, it would be impossible (well...) to do anything but allow the probes to do what we paid REES to have them do - monitor the temperature. We pay a hefty fee to have these calibrated annually. At this point that is all we plan to do. We too have had many FDA inspections and they reviewed our REES data in depth a few years ago.
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My answer would be a firm no. I agree that it might be possible to slightly lower it immediately, it will quickly go back to predonation levels. See this article too. Google will give you plenty of comments like this one: http://www.sciencenetlinks.com/sci_update.cfm?DocID=9.
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The staff of Donorlimits wish you a very Happy New Year.
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We have a very old policy, but it is only related to patients with clinically significant antibodies. The policy states to notify the medical director who may decide to give antigen negative units at immediate spin. Something we elected to do after our last aaBB assessment was to perform a gap analysis. It was rather enlightening and time consuming. We have a large staff and they all helped. We reviewed each standard and documented where it was met in our procedures, or where we weren't meeting it. It took many months to complete. The benefit is now we really know where we stand and what we need to accomplish.
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I have no specific advice, but I'd try and make it someone else's problem. Seriously. Call the manufacturer and ask for advice. Then take this advice and ask you facility service people how you can correct this concern. Let them know this is a patient safety issue. That's what I would start with, I hate owning problems.
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Chris, that is our practice too. What blood type do you assign to these patients? We are currently calling them A2 in the computer.
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How do you prepare your facility, especially the staff for any pending assessment you may have? I fully support that facilities should always be prepared; however, that is not always the case. With you response, please tell us what type of a facility you are and how many FTE's you have. We have aaBB and JCAHO lab in Jan - March 05, and our State DPH in December / January.
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John, We currently use a Nordion Gamma Irradiator, it is a few years old and at 3 minutes 36 seconds. Might seem quick, but it adds up fast when we transfuse at the volume we do. We are considering replacing it or adding an additional unit - possibly the CIS. I don't agree with the statement about FDA and also let's try and remember that some employees of FDA might also be members of this forum. I agree that it is not part of their mission to make our lives easier, their only mission should be to protect the public.
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The patient should only be getting billed for the features of the product they require, similar to antigen negative units. The reasons are very complicated. We transfuse about 50,000 products / year. We have a very large oncology transfusion population and identifying these patients can be complicated. Our IS system has a few triggers to help, but sometimes these patients sneak into the OR or ER and get transfused. Irradiated products can't hurt anyone; however, the disaster from a patient who needs it but doesn't get it...
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David, I agree that it may help supplement the general inventory. I guess I want it both ways. Collecting autologous costs us a lot of money, we collect several thousand a year. We will start collecting significantly more, we have recently restricted auto collections to our facility only, we do not allow our local suppliers to collect for us, except in rare circumstances. We discard about 1/2 and obviously can't get reimbursed for those. So perhaps it's not the collection of auto units that frustrates us, but the over ordering.
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We are moving toward 100% irradiation, first we need another irradiator though. Is anyone considering that?
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Brian, I suspect FDA would not mandate such a thing, that would getting involved in the practice of medicine. I'd rather see a fully leukoreduced inventory too.
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My apologies to Jane who has posted this poll twice, and in my carelessness I have deleted it. It is now reposted, sorry Jane.
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Thanks for the clarification John. We are a rather large transfusion service so the idea of not being registered is rather foreign to me. I read this statement from the 2004 CFR: (d) Manufacture means the collection, preparation, processing or compatibility testing by chemical, physical, biological, or other procedures of any blood product which meets the definition of a drug as defined in section 201(g) of the act, and including manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process. The term includes packaging, labeling, repackaging or otherwise changing the container, wrapper, or labeling of any blood product package in furtherance of the distribution of the blood product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.