Cliff
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Posts posted by Cliff
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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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Cliff, I hate to disagree with you but crossmatching does not require FDA registration. As long as you do not "modify" any blood products you do no have to register with the FDA. Pooling, Packing, Thawing, Aliquoting and Dividing are not modifying. Irradiating, and Washing are modifying.(I'm sure there are others but I can't think of them now.) The reason I know this is that our corporation is the only one with the distinction of having transfusion services under a consent decree (long story). We are not allowed to modify blood products but we can do Pooling, Packing, Thawing, Aliquoting and Dividing. We do all other pretransfusion testing and are not registered.
Hope this helps.
John
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.
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Do you already perform compatibility testing? If so, then you'd need to be registered. If not and these are new processes that you'd be adding to your operations you would need to be registered for that too.
Here is a link to the appropriate CFR: http://a257.g.akamaitech.net/7/257/2422/12feb20041500/edocket.access.gpo.gov/cfr_2004/aprqtr/21cfr607.3.htm
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Jane, there sure is, it is actually a little different / better than before.
Here are the steps:
On the main forum page, click on a category, i.e. Quality.
On the right there is a "Forum Tools" menu with an arrow on the right, click the arrow.
Click "Subscribe to This Forum".
Select the frequency for notification.
You should start to receive either daily or weekly notifications.
I am redesigning the newsletter page I had sent in the past. It should be ready in a week or two. Once done I will send updates at least once a week. Some of the newsletter features will be recent posts, tips on how to use the forum and some statistics.
Hope that helps.
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Here are a few free tools i really love.
I listed the tool, the link, my rating, and some text from the authors site.
Google Bar
Rating - 10
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ieSpell
Rating - 10
ieSpell is a free Internet Explorer browser extension that spell checks text input boxes on a webpage. It should come in particularly handy for users who do a lot of web-based text entry (e.g. web mails, forums, blogs, diaries). Even if your web application already includes spell checking functionality, you might still want to install this utility because it is definitely much faster than a server-side solution. Plus you get to store and use your personal word list across all your applications, instead of maintaining separate ones on each application.
Does not work with FireFox.
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Mozilla FireFox
Rating - 7
http://www.mozilla.org/products/firefox/
This is a very good replacement web browser for Internet Explorer haters. It is not based on the IE structure, it is a completely new stand alone browser.
I can't possibly give even a small list of the features this tool has. Take a look at their site and also see some of the add on options available, you'll never go back to IE.
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Rating - 9
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Rating - 9
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RoboForm is a free password manager and one-click web form filler with some serious Artificial Intelligence.
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Rating - 9
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I have been using this web based email for a few months now. I've tried them all and I think this one is just terrific. Free mail, free file storage, free photo gallery... All Free!
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Our WB donor center will giving fleece scarves as thank you gifts and doing various events, giving out cafeteria meal tickets and running raffles.
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So, using this technique you are essentially certifying your own weights, traceable to your NIST traceable. That's an interesting option, especially for us, we have a lot of weights, many custom.Weights used in the collection/creation of blood components have to be traceable to an NIST standard. We have a master set of weights that is sent out each October for certification. All other weights used in our facility are measured against the master set annually.
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I am in the process of revising the database we use.
For the end user it is rather simple, they enter the donors ID number and if they have been in the database before it displays their name, if not they need to enter them. There is no link between this database and any other LIS, it is completely stand alone.
Then they enter a few standard parameters, they select a donation type (radio buttons), they enter the current hemoglobin, sample volume, we collect leukopacks so they enter that volume, plasma loss, date of donation (today is defaulted) and donation number.
At the end of this entry they print a report that lists the items I wrote in the first post.
There are many custom controls specific to our facility. Someone with moderate Access building experience can probably find these items and modify them.
I’ll be happy to post it here if people are interested. I can’t create a customized version for everyone. If you are interested in having it set up for your facility e-mail me and let me know and we’ll work something out.
Some of the big drawbacks are Access is not stable in a shared environment, we have moved ours to an application server that IS controls. Prior to that it was on a shared drive and it became corrupted occasionally. Also, access to the program is controlled at the drive level, so the application does not track who does what, to me that is huge. FDA has seen it twice and has not had concerns with that issue.
I have considered making this into a web-based product, that would eliminate all of my concerns and make it useful for many more people.
Washing SD platelets on the COBE
in Transfusion Services
Posted
Laura,
Would you be interested in sharing your SOP for this? We wash a fair amount of platelets with limited success.