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Deb

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Everything posted by Deb

  1. I'm not aware of any requirement for the Medical Director themselves to review the actual collection records. I'm wondering if this is in reference to CFR 640.3 (a), where it says: The suitability of a donor as a source of Whole Blood shall be determined by a qualified physician .... or by persons under his supervision and trained in deterining suitability......etc Read on in the CFR and there is an explanation of how/when other staff can perform certain duties. Likewise AABB standards indicate the Medical Director is responsible for activities....but they may be delegated to other personnel. Std 1.1.1
  2. Take a look at Harrington Quality Management System...HQMS. It is web-based and you get access to all of the modules. We just implemented the Document Control module. They do have CAPA, Training, Task Management, Dashboard, etc. I'm not real familar with reporting processes and customizing them. The system is not blood bank specific but is implemented in many industries and seems to be pretty customizeable. Worth a look at anyway.
  3. We also use the same specific gravities that you listed.
  4. Terumo also makes a metal clip. Theirs is round as opposed to rectangular.
  5. Sorry, I didn't see your request. I believe we went with a bag of wet ice in the bottom of the cooler, a layer of insulation (i.e., paper or cardboard) the units, insulation and another bag of wet ice on top. If you send me your email address I can send you a copy of our packing configuration--- that is, if you still need it!
  6. We used the ISC coolers as well and now that they are no longer on the market struggled to find a replacement. For units that are being transported from a blood drive back to the center we ended up going with Coleman Coolers (on wheels) from Walmart and coming up with a packing configuration that would successfully cool the units "towards" 1-10 C. We used data loggers at different positions in the coolers when we validated to show that the cooler could successfully handle this and validated the process for 24 hours "just in case" something happened to delay the delivery of the cooler. What I found from validating the ISC coolers and the Coleman is that it usually takes at least 6-8 hours for the temps to drop to below 20 C....and we usually have them back at the center within 4 hours. Really, all you have to show is that the cooler is able to continuously cool the units "towards" 1-10 C.....not that they actually reach 1-10 C during your transport time.
  7. I had asked our Consumer Safety Officer at CBER for a reference within the CFR regarding review of policies. Her reply was that the CFR does not specify annual review of policies.
  8. We are implementing Harrington Quality Management System. It is web based and has CAPA, Training, etc modules as well as Document Control.
  9. Being a cautious person, I would call Ortho and discuss the issue with them. If they have outsourced their service for some reason, I would think they would have communicated it with you.
  10. We used to keep a crash cart in our hospital based donor room, but it was primarily there because we also had RN's performing therapeutic exchanges on patients. That service was transfered and some years ago our organization determined to remove many of the individual service crash carts because there was a lot of maintenance involved and most supplies/drugs were expiring. In any case, none of my staff are trained or licensed to use the supplies on a crash card and the crash team also responds with applicable crash cart supplies. Check with your response team, they probably bring a crash cart with them.
  11. As a collection center that prepares and freezes plasma we also simulated different loads of warm units and freeze times. We used small data loggers placed in alternating positions (front/back or left/right) on each shelf/drawer to map what happened to the temps in each area as the freezer was loaded. We did a single unit on each shelf. Six units all at once. Multiple loads placed in the freezer at different time intervals, and one large load that might simulate after a busy day/blood drive. What we found was that certain places were best for quicker freezing and others were better for maintining the frozen temps. We used water bags to test this. If you want more details, feel free to let me know and I can forward more info to you.
  12. CLSI (used to be NCCLS) has a Tentative Guideline: Temperature Monitoring and Recording in Blood Banks. NCCLS Document 16-T Vol. 6 no. 19 hints that alarm sensors should be tested monthly. 5.3.1(2) Platelet Incubator-Rotator but then uses the term quarterly for blood refrigerator and freezers. I have requested clarification from CLSI, but have not heard back yet.
  13. We are struggling with finding an effective way to keep our apheresis donors warm enough to minimize the vasoconstriction and draw pressure alerts. We've tried the chemical hand-warmers you can purchase but they don't seem to be very effective. I received a suggestion to use a heating pad which I think might be the ticket...but, as we are a hospital blood center, we are encouraged to use 3-prong (grounded) electrical plugs. Most heating pads I see have only the two prong plug. Does anyone have a vendor suggestion ... and/or any other suggestion for keeping our donors warm? Thanks! P.S. .... It's no wonder we have difficulty it was well below zero F today....
  14. Heather, Cliff.... Would you be able to share your document? I would also like to discontinue using the CUE ballot (I know, we are behind the times in this!) you can send it to me at dschue@altru.org Thanks!
  15. The 2007 FDA Guidance for Platelet Apheresis collection defines limits for concurrent plasma collection on pg. 7 point number 4. Trima plasma storage bags have an upper limit of 600 ml. Annual cummulative plasma loss is limited to: 12.0 liters/year if the donor weighs less than or equal to 175 lbs. 14.4 liters/year if the donor weighs greater than 175 lbs. I would call my CaridianBCT Rep (or TerumoBCT rep - since they merged) for details on how Trima calculates the volumes it collects. They can help you establish the configurations for plasma collect based on your collection goals, regulatory requirements, and what Trima is labeled for collecting.
  16. I've attached 3 documents that we used when we implemented ISBT. You may or may not find them helpful. 1. Label Validation Master Form: We verified all of the fields of a label were in the correct position, indicated the correct wording, etc. 2. The Label Sample page was how we compiled our Master Label Sets. 3. Label validation Scan Page allowed us to scan related labels in to verify they scanned correctly. [ATTACH]534[/ATTACH][ATTACH]535[/ATTACH][ATTACH]536[/ATTACH]
  17. We are in the process of setting up a web based system that we purchased primarily for Document Control. But it also offers several other modules (at no extra cost) for corrective action, project planning, training, etc. The system we purchased is HQMS: Harrington Quality Management System. You can check their web page out and contact them for follow-up if you are interested in what you see. If you want to visit more about it send me an email and we can set up a phone call. dschue@altru.org
  18. We also have two different models of Sysmex instruments. What I found was that one consistently reported values significantly lower than the other. To minimize impact of one more variablilty in the process we have all of our pre-donation samples and product QC samples tested on the same model.... You may want to check the correlation of the two hematology instruments using platelet samples. A 7% disparity between instruments has a much bigger impact when you are testing levels at x10<11> vs. X10<3>. You might be surprised!
  19. On significant difference I found when I did our CAP self-audit was this: 27th Edition AABB Std 5.7.5.20 and 5.7.5.21 require that 90% of the apheresis platelets tested have >/= 3.0 x 10<11> platelets at the end of allowable storage or at the time of issue. CAP Std TRM.44900 (Revised) requires at least 95%.
  20. We have a transfusion service but I asked this same question of another center and their qc sampling was to test "N" of platlets on day 2, on day 3,4 and 5 as they issued them to transfusion services. This was considered "end of storage" at the blood center. They developed this approach via their FDA CSO
  21. I donate 3 times per year for 20 years and spend about 45-50 hrs at work per week. Just a thought, if you have a blood bank that you can contact, they may be willing to put out a simple little questionnaire to their donors who could then respond to you directly via email.
  22. Back to the original question. There are no requirements for recipient notification if a donor is reactive in HBcore only. The purpose of lookback is to quarantine any in-date units that might still be in inventory somewhere (i.e., a frozen plasma from a previous donation would be one example).
  23. Glad to hear the mystery is being investigated....Please let us all know the outcome so we can all learn from it!
  24. Liz, I would strongly encourage you to contact the manufacturer of your apheresis equipment and ask them to help you resolve it. They may wish to have the collection sent to them for investigation. I would be more inclined to think it related to something triggered by a colder room temperature. Is your collection area near a window that is exposed to colder air? Or under an air conditioning vent? This may sound silly, but living in North Dakota through winter seasons makes me think this way!! We actually found a frozen water pipe in one of our exterior walls because the builders neglected to insulate that wall...go figure, but strange things happen just to keep our lives interesting!
  25. What you are describing here is called a "Dedicated Donor" (Testing 1x per 30 days). My understanding is that their is a catch: all of the products collected must be dedicated to the same patient....
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