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RoseM

Members - Bounced Email
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About RoseM

  • Birthday 09/04/1950

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  1. RoseM

    GMP Training

    Hi, I am an Educational Coordinator in Transfusion Service and i am currently conducting the Annual cGMP training as required by the FDA. QA needs to approve the training materials. All new hires are required to attend the Introduction to cGMP which our department developed. For the annual training, i pick a hot topic e.g. Documentation, Equipment Maintenance and QC etc. I start with a discussion on the related GMP regulations, identifying GMP elements violated and their consequences. I started this year with a pre-quiz focusing on the actual reported events and ended the training with discussing corrective and preventive actions for the events discussed...and then a post quiz.
  2. It will take about 10 min to get the ABO type using the CAT and will need a centrifuge. If you have a power outage and hundreds of trauma victims at your doorstep, what is the quickest and safest way to provide blood while still conserving your O units?
  3. What is your policy on assessing staff competency? You have to set your own standards. In our institution, we would do remedial training, verbal warning, and finally termination especially if patient is harmed or there is a potential to harm the patient. Document the errors and work with your HR.
  4. Will your laboratory consider performing ABO typing using the slide method, in case of a disaster? (Scenario: An earthquake happened at night and caused power outage. Your hospital is deluged with hundreds of trauma victims. The hospital set up treatment area in the parking lot.)
  5. Hi Lara. Thank you for your comment. We are revisiting our policy and we want to know what is the common practice, specifically if MD approval is required and if RhIg is recommended given the argument that the rbc contaminant is negligible. The counter argument is that the risk is low but the consequence is significant.
  6. Thank you all for the valuable information you shared with me. I posted a Thank You note but i don't know where it went (I am new to the forum).
  7. Hi adiescast, I am not clear about your policy. If you have no Rh- plts in your inventory, what do you do?
  8. What is your hospital policy regarding transfusion of Rh+ platelets to Rh neg patients who are of child bearing age, neonates and pediatric patients regardless of sex, and bone marrow transplant patients with a special need of "Rh neg platelets only". The argument is that if rbc contaminants on plateletpheresis is almost negligible, is it necessary to give RhIg? Do you still ask for MD approval to give Rh incompatible platelets?
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