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Quality_Lady

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About Quality_Lady

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  1. Carrie - would you consider sharing your plan - or at least a high level summary of your rationale for the number and distribution of samples / cells tested? Thanks!
  2. MOBB - We are looking at Immucor and / or Quotient. I have heard through the grapevine that Ortho cells do not work well - the make-up of the diluent interferes.
  3. Has anyone validated the use of other manufacturer's (Ortho, Immucor, Bio-Rad, Quotient) reagent red cells in the Grifols gel system. I realize that they need to be washed, and resuspended to 0.8% in Grifols diluent. What I am looking for is general information on the actual validation performed - how many cells what antigen groups distribution between positive and negative cells use of patient samples for testing Also - what is probably more of an issue. Have you been inspected by FDA (or CAP, AABB) and has your plan been accepted? Thanks in advance for your help.
  4. We are looking to revise our blood consent process so it is applicable at all our practice sites (including those where a physician may not always be readily available) and of course remains compliant with regulations. In reviewing various requirements, AABB and CAP discuss the elements of consent for transfusion, but are silent on who may administer that consent. The Joint Commission states that “Obtaining informed consent presents an opportunity to establish a mutual understanding between the patient and the licensed independent practitioner or other licensed practitioners with privileges about the care, treatment, and services that the patient will receive”. By our reading, this indicates that other licensed providers who are not physicians (eg, nurse practitioners, physician assistants, registered nurses) can obtain informed consent. We would like to benchmark this practice, and so we are interested in who you allow to obtain informed consent in your hospital? Thanks
  5. Quality_Lady

    Acceptable glass tubes for blood bank testing

    The Kimble tubes showed up in our lab. Has anyone found more information regarding the new labeling? We are awaiting information from both Kimble and Fisher.
  6. Quality_Lady

    Preparation of DTT for treating RBCs

    Exlimey - What I was referring to is the confirmation / validation that the use of the materials as described in the post works in the manner they are being used, provides equivalent results, and there is parallel testing with accepted methods (e.g., buffering with NaOH) showing that the use of either solution gives comparable results in the hands of the lab.. Catchnenow51 - Did not intend to hit your hot button, just wanted to give you food for thought before an inspector asked the same questions. I came from medical devices so I have heightened expectations of regulatory impact. Plus there is no data to support the expiration date and stability of the PBS prepared in this fashion.
  7. Quality_Lady

    Preparation of DTT for treating RBCs

    Use of either pHix or Buffering solution as described is outside of IFU and would require extensive in-house validation to support their use. Not only would you have to provide "in-use" testing, you would also have to determine stability data.
  8. Quality_Lady

    Fetal Bleed Confirmatory Testing by Flow Cytometry

    Thanks Colin - This is just the information that I needed.
  9. Quality_Lady

    Fetal Bleed Confirmatory Testing by Flow Cytometry

    Thanks Colin - This is some good information. Can you provide any clarification as to what you did to initially verify the assay in your lab? Thanks and Happy New Year!
  10. Has any facility implemented the Quotient flow methodology for confirming fetal bleeds? We are looking at using it to do testing and are in the planning stages of how to “verify / validate†the assay. If you did implement, can I ask what you did to implement the assay and verify that it worked in your hands? Thanks!
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