Cliff
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Everything posted by Cliff
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Jane, Here the reply from Websense, I guess it just depends now on how often your IS team updates the database. I presume it's automatic. ---------------------- Mr. Reeves, Thank you for writing to Websense. The site you submitted has been reviewed and classified under the category Health. This update should be available in the next publication of the database. Thank you for your assistance, The Websense Database Services Staff PW
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Jane, as an update I noticed that the prior site, donorlimits.com was categorized by Websence, and this site has not yet been categorized. I just contacted them and requested they categorize them the same. Hopefully they'll respond soon.
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Pneumatic Tube systems for Blood Transport
Cliff replied to Ellis M. Frohman's topic in Transfusion Services
Ellis, I haven't read John's SOPs, but the process you describe is what we do. One staff person always reviews / issues all of our products. It is not different for the tube system, issuing to a cooler or issuing to transport staff. -
Websense is a filter your IS admins are using to ensure you are viewing appropriate sites. Maybe once this site has been evaluated by Websense it will get through, not sure. Are you allowed to ask your IS people to unblock, or allow sites? I'm sure they'll find this site acceptable, we do not have any inappropriate material here and never will, and I read every post to ensure it stays clean.
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Electronic method of capturing non-conformances
Cliff replied to Dawn's topic in Education / Quality
Thanks for the great responses. We actually use a database and a web site to track our (I work with Dawn) Occurrences too. This gives us a few additional benefits, such as we can track who each Occurrence is with and the site sends automatic e-mails reminding them to finish processing them and turn them in. The problem we face is more a timeliness issue. The staff seem to take a long time processing the Occurrences and returning them to me. Do you have success with getting them completed? -
Just sent it, enjoy.
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Just sent it, enjoy.
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Sorry about that, not sure what happened, I just sent another. Let me know if you get that one.
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This has been sent, enjoy both.
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I am responsible for just the compliance of our donor centers and transfusion service. I also have one person who works 32 hours that reports to me. Even with this we always feel behind. Our clinical laboratories has a separate individual responsible for laboratory compliance. We do not report to one another but work closely together. Our department is not part of the clinical labs, but part of pathology instead.
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Not sure if Gmail will know it already sent you one. E-mail me the address you'd like the invite sent to and I'll be happy to send another.
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Hi Jason, Welcome to our forum. I am the compliance officer of a Boston teaching hospital. We have two small donor centers and a 750 bed hospital. The transfusion service is very active, we transfuse about 37,000 rbc / year. I have one part time person who works for me. In all we have about 100 staff which includes the supervisors and medical directors. My position came about around 8 year ago when we had a less than favorable FDA inspection. Unfortunately this can be the impetus for positions like mine. It's a tough financial decision for a lab to make to support a full time compliance position. Since you are meeting some resistance, maybe the request could be for a part time person? A full time compliance person in a lab your size could be more than you will need. Granted, it might feel like you need it now, but once things stabilize a little, they will have less to do. Just a thought. Good luck and welcome again.
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I just sent you one, I have plenty left still.
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It's been sent.
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Maximum # of whole blood collections/year
Cliff replied to conwaysbb's topic in Donor Services and Donor Recruitment
I found this in the 1963 4th Edition of aaBB Standards: "Except for reasonable qualifying circumstances, the interval between individual donations should be at least 8 weeks." I could not find a reference to the interval in the 1-3 edition of Standards. So it looks like aaBB has required the eight week interval for quite some time. I didn't find any aaBB references to maximum number of donations for WB. -
Just sent it. Enjoy.
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For those following this thread, part of the reason we are changing our practice is this requirement from JCAHO to QC each open vial, this is the 2004 edition, I don't 2005 handy, but I don't think it's changed: Standard QC.5.220The laboratory tests for reactivity the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations on each day of use and when a new lot of reagents is first used. Elements of Performance for QC.5.220 Each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and when a new lot of reagents is first used.The laboratory confirms that each reagent reacts as expected. Results are documented.
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What do others think about using only positive controls? Most of our manufacturers only require a positive control. Currently we perform both positive and negative controls, just as described by Jane. Personally I am opposed to only doing positive controls, but unless I have evidence that it's wrong I will be outvoted. I think using a positive control only method is about as valid as not performing QC at all.
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The invites have been sent to the above people requesting accounts, please let me know if anyone one else wants one, I have plenty of invites left.
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Kochman, Welcome to our forum, and thanks for your thoughtful contributions. Would you have suggestions on a validation plan for a situation such as what Walter presented? We are caught in a tough place ourselves. We will use a specimen up to 28 days from the time of collection (in some cases), yet the manufacturers directions state that we can only type them for 10 days (with our tube type). Where would one turn for validation suggestions? Our first thought was the manufacturer, but they could not offer any advice accept to validate our methods. In FDA's opinion, what would be considered a valid validation? In both examples, Walter's and ours, would we run 10 tests, 20, 100? For us time is clearly a factor so we'll need to ensure that the same results are obtained up to 28 days. There is no "rule" on in-house validation and we obviously want to do the right thing. Suggestions are always welcome.
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Maximum # of whole blood collections/year
Cliff replied to conwaysbb's topic in Donor Services and Donor Recruitment
Do you know what that Standard stated? Or possibly what edition of Standards? I have the disk with all versions so I could take a look and see. We do not use a limit for the total number of wb donations per year, just the 8 week weight for wb, or 16 weeks for a double BC collection. -
I know everyone has been anxiously awaiting our decision on the new name. :tongue: First thanks to all who posted here or contacted us directly. We have decided on BloodBankTalk.com. During the month of February the new site will be built and we will transfer this site over to that new domain. We will make several more announcements and send a few newsletters reminding you of these changes. More to follow...
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I have some invites to Gmail. If anyone is interested just e-mail me and I'll send you one. Don't know what Gmail is, read here to see if you'd be interested. http://gmail.google.com/gmail/help/about.html
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Thank you for your dedication as a blood donor. I understand your frustration, but please know that there is no charge for the blood itself. The charges are related to items such as: Viral marker testingDonor staff collecting the productThe product containerLab staff who crossmatch the productNursing staff who administer the productThese are the costs of providing safe products to patients. The charges to the patient are for the testing and services related to the blood products, not for the blood itself. Different hospitals charge different amounts for the transfusion. A community hospital does not have the high overhead that a large university teaching hospital encounters, so the overall costs are likely to be lower. We hope that the experience with your mother does not turn you away from donating, blood truly is a precious resource that we rely on donors such as yourself for.
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Thanks Pat, I think it's great that you posted this here for people to review. Hopefully some members from here will take a look.