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Cliff

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Everything posted by Cliff

  1. 1. Albumin - pharmacy 2. Clotting Factor concentrates - BB 3. Rh Immune Globulin-intramusular - BB 4. Rh Immube Globulin-intravenous (WinRho) - BB 5. IVIg - pharmacy
  2. 131 downloads

    Blood and blood components
  3. I second this! I have been using it for a couple of years and even purchased it. The one drawback is when you are not on the computer it is installed on you forget passwords. :roll:
  4. We are at a large facility and we are not doing this either.
  5. Welcome Margaret. It looks like you were able to make your first post, so you're off on your way! We are not affiliated with AABB. While their forum is helpful, it is very difficult to get to and navigate. We hope to offer Blood Bankers another way to communicate. Also, we require no membership fees. :wink:
  6. While the administrators and moderators of this forum will attempt to remove or edit any generally objectionable material as quickly as possible, it is impossible to review every message. Therefore you acknowledge that all posts made to these forums express the views and opinions of the author and not the administrators, moderators or webmaster (except for posts by these people) and hence will not be held liable. You agree not to post any abusive, obscene, vulgar, slanderous, hateful, threatening, sexually-oriented or any other material that may violate any applicable laws. Doing so may lead to you being immediately and permanently banned (and your service provider being informed). The IP address of all posts is recorded to aid in enforcing these conditions. You agree that the webmaster, administrator and moderators of this forum have the right to remove, edit, move or close any topic at any time should they see fit. As a user you agree to any information you have entered above being stored in a database. While this information will not be disclosed to any third party without your consent the webmaster, administrator and moderators cannot be held responsible for any hacking attempt that may lead to the data being compromised. This forum system uses cookies to store information on your local computer. These cookies do not contain any of the information you have entered above; they serve only to improve your viewing pleasure. The e-mail address is used only for confirming your registration details and password (and for sending new passwords should you forget your current one). By registering, you agree to be bound by these conditions. I Agree to these terms and am over or exactly 13 years of age
  7. I agree that would be nice. We also have a fairly active pheresis center and four Trima so we could do that but... We have a home grown LIS and it can't handle that type of collections. We are in the process of negotiating a new system and it should be functioning mid next year. At that point we can consider this option and many more!
  8. That sounds like a great idea. We have two centers, one relatively small WB center and one fairly active plateletpheresis center. The platelet donors are very dedicated and it's hard to get them to not donate. The WB people are a bit tougher. I think food has worked well. We had a few days were the staff made homemade breakfasts cooked to order while you donated. It was a big hit.
  9. We are a large transfusion service with a smallish donor center. For us the staff is enthusiastic about using the device (we have one Haemonetics), but the criteria for the donors is a bit harder. Most women don't qualify and they make up the majority of our donors. Then there is HT increased time commitment. For me I actually prefer to donate this way, so then I have four months off between donations and don't need to feel guilty if I don't go every two months. Plus the validation was time consuming. Not that it was a lot of work, but it took a long time with the frequency of the donors. Are you using it now?
  10. Well.... Yeah that's kinda the idea. Thanks again for the suggestion.
  11. AABB recommends that donors be deferred for one year from the departure of Iraq. The CDC indicates Iraq malaria status as "Risk in the provinces of Duhok, Erbil, Ninawa, Sulaimaniya, Támim, and Basrah." We currently consider all of Iraq a malaria risk and don't plan to take further action. Does anyone have another approach?
  12. Hi lim26, You might want to have a look at the FDA;s recall wbesite. They are at http://www.fda.gov/cber/recalls.htm. Also, here is an intersting article: Erstad BL. Viral infectivity of albumin and plasma protein fraction. Pharmacotherapy 1996;16: 996-1001.
  13. Welcome Kate. I am hoping that we will be able to use this forum to share blood bank ideas with people outside of just the Boston area. I've looked for a while for a forum like this and since I couldn't find one I liked, I decided to start one of my own. We hope this to be a successful exchange of ideas.
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  15. Lynn, Thanks for the great suggestion! This forum has been added.
  16. This forum will e-mail you a link to recreate your password. Passwords are one-way encrypted into the database. No one can look them up for you. You need your username and e-mail address to create a new password. If you can't remember your username, please e-mail me by clicking on my name above and I will look it up for you.
  17. Version 1.0.0

    0 downloads

    Docket Number: 2002D-0080 Issued by: Center for Biologics Evaluation and Research Blood and plasma establishments (hereafter referred to as “blood establishments”) that collect blood and blood components intended for transfusion or for further manufacture may present donor screening questions to the donor by several methods. The blood establishment should choose the method that works best within its donor screening procedures. This guidance is intended for those blood establishments that wish to implement self-administered donor questionnaires, which allow donors to answer the pre-donation questions on their own; however, you (the blood establishment) may elect to continue to administer the donor questions by direct oral questioning. The guidance provides the recommendations of the Food and Drug Administration (FDA) for implementing self-administered donor questionnaires. In addition, the guidance describes the information the licensed blood establishments should include in a biologics license application supplement or annual report when they intend to implement self-administered questionnaires. This guidance finalizes the draft guidance of the same title dated April 2002. It also supersedes Section I.A of FDA’s memorandum dated April 23, 1992, entitled “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.”
  18. Version 1.0.0

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    Docket Number: 02D-0362 Issued by: Center for Biologics Evaluation and Research This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and quarantine and retrieval of blood and blood products in cases of donors exposed to vaccinia virus, which is the virus used in smallpox vaccines. The presence of vaccinia virus in transfused blood or plasma could be harmful to some recipients. Although the presence of vaccinia virus in blood (viremia) has rarely been documented, this possibility has not been assessed using modern laboratory techniques. Therefore, the risk of transmission of vaccinia virus by blood and blood products is uncertain.
  19. Version 1.0.0

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    Docket Number: FDA-1997-D-0029 Issued by: Center for Devices and Radiological Health Center for Biologics Evaluation and Research This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.
  20. Version 1.0.0

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    Docket Number: 01D-0545 Issued by: Center for Biologics Evaluation and Research This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and product safety for donors potentially exposed to Bacillus anthracis, the agent of anthrax. This guidance applies to Whole Blood, blood components (including recovered plasma) and Source Plasma collections intended for use in transfusion or for further manufacturing into injectable products. FDA developed the recommendations in this guidance in consultation with other Public Health Service Agencies and with the Blood Safety Committee of the Department of Health and Human Services.
  21. Version 1.0.0

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    Docket Number: 99D-2213 Issued by: Center for Biologics Evaluation and Research To reduce infectious disease transmission by blood and blood products, donor samples from blood donations are tested for markers of pathogenic bloodborne infections, including antibodies, antigens, and nucleic acids that may indicate the presence of etiologic agents such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphotropic virus (HTLV), cytomegalovirus (CMV), syphilis, and others. The validity of screening and supplemental (confirmatory) test assay results is determined by the performance of test kit manufacturer supplied reagents labeled as Acontrols@, used in accordance with the test kit instructions.
  22. Version 1.0.0

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    Docket Number: FDA-2022-D-0485 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.
  23. Version 1.0.0

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    Docket Number: FDA-2007-D-0251 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in the premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for empty containers for the collection and processing of blood and blood components used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.
  24. Version 1.0.0

    0 downloads

    Docket Number: FDA-2022-D-0484 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.
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