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conwaysbb

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Everything posted by conwaysbb

  1. If you don't mind , would you be able to tell me the % increase that Ortho was notifying you and what Immucor was notifying you? What vendor did you select and why.
  2. I wanted to know what effect the recent price increases from both Immucor and Ortho have done to your budgets. Also how has this effected the relattionship with you major supplier, how has this changed your point of view on your major supplier and do you think the recent astronomical increase in pricing are truly the effect of recent manufacturing expenses or is it because their are only two major blood banking reagent players now? To start, I will give you my answers/opinions. My budget for 2005 was required to be in by August 2004. The notification form my major reagent supplier was sent to me in November, 2004. This caused my pricing to increase an average of 87%, almost $50, 000 increase. This on top of the previous years increase, consolidation of available reagents or discontinuation of reagents and a increase in customer service complaints due to shipping/non-shipping issues. I have been told that Ortho, which I do not use, has increased their pricing 200-400%. I am having my Ortho rep come in this week to talk to me and verify what I have been hearing. I know this has effected my relationship with my sales rep and Immucor. There reasoning for the sharp increase in pricing seems to be very thin and does not correlate with what they reported to their own stockholders. (Lab administrator has read the stockholder's report). I do not know if the 200% -400% increase in reagent pricing by Ortho is true, but it is my opinion that Immucor is taking advantage of this situation and raising their pricing accordingly, but not as much as Ortho to take advantage of dissatisfaction by customers who Immucor expects to jump shift. (which incidentially is is one of the reasons Immucor says is the cause of price increase as they have to increase production and add new shifts). I also firmly believe that after BCA went out of business and Immucor adsorbed some of their manufacturing, plus Immucor's takeover/merger with Gamma, that left only two major players available and we are now seeing the result of the monopoly of Blood Banking reagents by Ortho and Immucor. But that is just my opinion. What's your take?
  3. Jane, I went on this site. Lots of different opinions, and different policies. Some of them are confusing an emergency release protocol with a massive transfusion protocol. It gets more confusing when I read so I will have to try to distill all the information down to a workable policy. It looks like a minimum of 10 units is the standard to initiate a massive transfusion protocol. Are you going to develop a massive transfusion protocol to meet AABB standards? Still looking for additional policies, protocols and opinions.
  4. I was recently assessed by the AABB and was cited for not having a policy for massive transfusion. We had previously decided our hospital does not require one, because we perform an IS x-match and also transfuse blood components as needed, not based on a formula. As the standard now requires that you have a policy for massive transfusion, (i.e. compatibility testing when, within 24 hours, a patient has received an amont of blood approximating the total blood volume), can some indiviuals share with me there massive transfusion protocol, or can share with me their statement that their massive transfusion ppolicy is not to have one at all?
  5. Hello, Would anyone be willing to share their RFPs or RFIs. We are looking at different blood bank systems which must include a donor package. I would appreciate it if anyone has an RFP/RFI , especially one that has questions for donor services. You can attach to this thread or e-mail me at conwayM@sjhmc.org Thanks for looking
  6. Having been involved in several validation for blood bank computer systems over the years, it has increasing become very time consuming, and personally I don't have the time or the resurces to do this in-house. I have used the services of an outside third party validation service for the last two upgrades. I know that several of the blood bank computer companies are offering validation services, but I have a issue with the services offered. There is a serious conflict of interest here. Validation should include trying to identify if there are any faults to the functionality of the system as you are using it. You are trying to break the system. If issues come up you notify the company and they fix it or you need to include a work around. Many upgrades to the computer systems involve issues that are reported to the computer company by their clients when they validate the system. This costs the company lots of $ and time. So how much trust would I give to a validation service that is directly associated with the company? If they find an issue will they report it to you, will they sugar coat it when they inform you, will their testing even try to break the system? I personally would not have 100% trust. The FDA also recommends that if you are using an outside validation service you should use a third party validator. I have used Korchek Technologies, but know about RFNozick and even Validation Partners and feel that they all would give you valuable validation services and have only your best interests at heart.
  7. If you have information that as a male, she (he) had sex even once with another male since 1977 then you would be obligated to defer indefinitely. That would be required if she had answered truthfully during medical history review or subsequently during her collection. I would just document on medical history that she fell under the FDA regulations during the time she was still a male, which is considered high risk behavoir and an immediate indefinite deferral and will continue until such time as the FDA changes their rules. As for if she never divulged the information, well... then we have no information that this happened so this question is moot.
  8. Unfortunately for the blood banks in New Jersey wh have the blood Safety Act of 1992 that requires any physician to inform their patients of the alternatives to receiving volunteer blood to include directed and autologous. We are also required to accept any autiologous or directed blood from any outside blood center. Additionally, there is a New Jersey State Department of Health requirement that we can not cross over auto units, we waste approximately 50% of our units. However, as we offer autologous and directed collections at our facility , it is a benefit in attracting patients to our facility and we can always corssover our directed
  9. Thanks for all those who answered this post, and the SOPs that were offered were great . Again thanks for youe assistance. Mike
  10. We also have the double door Helmer refrigerator. We initially had a problem with the chart recorder, which took awhile until issue was rectified. We have recently has some small parts come off the bottom of one door. This piece helped keep the door from swing all the weay open. Overall we like the look of the helmer refrigerators and it keeps the temperature within the desired range. I do have the cheaper model, because of cost issue.
  11. Standards require that RBCs shall be prepared by sparating the red cells from the plasma portion of blood using a method known to result in a final HCT of < 80%. We perform monthly QC and have a standard of 90% of units must be < 80%. I do not have a reference for this . Does anyone have a different standard and what reference did you use? Also, do you discard units of RBC that do not meet this criteria? We use CPDA-1 as our anticoagulant.
  12. Christine, We switched over to Cotton Images for the last 2 years and have nothing but the highest praise for them. They routinely send us e-mail with new and interesting logos and even look for your own submissions and ideas. As for service, couldn't be better. Even when they made a mistake, they corrected their mistake and sent the corrected shirts without charging us again. If your going to AABB in Baltimore, they should be there.
  13. Ditto, Please inform us of the questions that need to be asked. It is without a doubt an extremely exhausting and frustrating feeling when getting a demo talk about interfaces whether it is between, the blood bank system(BIS) to LIS or BIS-to LIS-to HIS or even automation in blood bank and the interfaces to the BIS. It is usually double speak. What we all need is a list of questions that must be asked and answered to specify what can and can not be done, what interface issues are invoved, what is meant by support, validation, etc.
  14. ClayAdams Serofuge 2001 or 2002. Have several of these. I like it because it is easy to use, rembers that last time you used, will not open until unit stops and is very easy to do RPM and timer checks. However, recently we sent back a unit that we just received because the lid would not open and there was no manual way of opening lid. It was still under warranty (1 year) and they sent us back a new one which had the same problem a month later. We just sent it back for a replacement. Hope this helps
  15. We are presently a Hemocare user. We have MYSIS as our LIS and Invision as our HIS. We have a transfusion service, a donor service, apheresis service and also collect stem cells. We originally had Sunquest as our blood bank system but as we use lab assistants who thaw and pool products but do not do any patietn/unit/donor testing, Sunquest could not separate security functions and we were cited by FDA. While we are currently using Hemocare, there are several issues with this system. It does not interface very well with Mysis and Invision as the results ultimately have to go through 2 interfaces. We do not care for the service that Hemocare has recently provided us with especially since they had some issues with a FDA inspection. While we were negotiating upgrading the system to meet their FDA corrective action, their compliance /quality assurance dept. were not in synch with their sales force/technical services force, often resulting in mixed messages or to be blunt not knowing what the other hand was communicating to us. We found them to be very arrogant and unreasonable, but were forced to comply as they threatened and actually pulled our license for a short time. (we actually had FDA inspector approval to stay a a lowere version while we were looking at other systems). Anyway, I digress. We also have an issue with their automated back up system. We bought this system and when we tried to put it in their were little to no instructions on how to physically hook it up, and what was neede to place it into service including what validation to use. Again another service related issue. I have been exposed to the HCLL product and think that it is very nice, but again our recent experiences with Mediware has slightly soured us on this company. We had contracted with MYSIS for their blood bank package 6.0 but the contract had expired and they still haven't received 510K approval yet. Target date is not 12/04 (yeah I've heard that before). Not sure if they will be able to interface automation yet, which makes me feel hesitant. 6 years ago, the hospital system I was employed went over to Soft Lab and I did see the Soft Bank system. Was there in Tampa when they were 510 K approved. At that time the donor package was in its infancy and not available. I was pleased with there service. I guess we have to look at both the computer system itself and the service (Technical Service, Sales service, quality assurance and validation service) provided by the computer company itself. By the way is it me or does it seem like an oxymoron to have a blood bank computer company provide its own validation services. The whole pupose of a validation is to try to break the system. To expose the systems faults. This validation service provided by the blood bank system company has an inherent confict of interest. But thats just my opinion.
  16. Would anyone share their Proficiency Testing SOP which includes CAP specimens. If so, Please e-mail me at e-mail address removed by admin, spammers love to get new ones this way. Please send a private message to conwaysbb to learn the e-mail address.
  17. 1. Albumin - Pharmacy. We just moved it to Pharmacy 6 months ago due to billing issues and lost revenue. Our blood bank system is really not set up for albumin, paperwork for blood bank and nursing was complicated and stocking of floors and subsequent follow-up was a nightmare. Pharmacy is already set up for albumin and billing was more controlled. 2. Clotting Factor concentrates - Blood Bank 3. Rh Immune Globulin-intramusular - Blood Bank 4. Rh Immube Globulin-intravenous (WinRho) - Blood Bank 5. IVIg - Pharmacy
  18. When I took my present job, we were doing this on all plateletpheresis platelets and cryoprecipitate when we were giving these to non Group O recipient. This is not a requirement and is, in my opinion, non valued added when used for adults so we stoppred this practice. We also stopped the practive of doning anti A and anti B titers on O group packed cells going to neonates. Of course in this case we have to do an antiglobulin test for anti-A and anti-B before switching them back to type specific. We will perform titers if we have a pediatric patient who is non-group O and only group O platelets are available and they can not wait for volume reduction of platelets. The titers are at 1:50 and 1:100
  19. This is not required in the United States. There are some facilities like my own that preform this for sickle cell patients. My understanding of this in Europe is that anti Kell is a very commonly formed antibody.
  20. Hello, I am wondering if someone can assist me. I have recently been cited for not having an SOP for quarantine of previous donations for a donor who is now testing repeatedly reactive for any infectious disease. If someone could share their SOP I would appreciate it. This is separate from the Lookback SOP. As we all do not want to reinvent the wheel, This is an great way of saving time and energy. Please post here or you can reach me at e-mail removed by admin,please send a private message to conwaysbb to learn the e-mail address.
  21. Hello, I know this subject has been a tough issue to handle as well as develop. FOr that purpose I would recommend an excellent site that has helped me out tremendously. It is: www.mers-tm.net It explains a medical event reporting sytem that was developed for transfusion medicine through a grant by the NIH. Gives a lot of information, sample forms, and most importantly training information. Hope this information helps some one else. Mike Conway, MT(ASCP)SBB
  22. How about a forum for "requests for SOPs" or something to that effect. I am always having to revise or develop new SOPs and have always forund it easier if I had access to someone else's SOP.
  23. Hi David, As I am not an expert on this, I will just refer you to 2 articles in Transfusion: Detecting Bacteria in plateletr Concentrates by Use of Reagent Strips. Welch JB, Mhawech P, Stager CE, Banez EI and Lichtiger B. Transfusion 42: 1027-1031: 2002 Rapid Identification of Bacterially Contaminated Platelets Using Reagent Strips: Gllucose and pH Analysis as Markers of Bacterial Metabolism. Burstain JM, Brecher ME, Workman K, Foster M, Faber GH, Mair D. Transfusion 37: 255-258: 1997 Hope this helps. Mike Conway, MT(ASCP)SBB

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