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amyhlandry

Members
  • Posts

    2
  • Joined

  • Last visited

  • Country

    United States

About amyhlandry

  • Birthday 10/05/1978

Profile Information

  • Interests
    Jewelry making, reading
  • Location
    Louisiana
  • Occupation
    Supervisor of Lab Compliance

amyhlandry's Achievements

  1. We use the echo and its not uncommon to get weak reactions in the original antibody screens (as we have all heard). To make certain that these reactions are non-specific and not clinically significant we perform panels on the echo and then additional screen using diffrent technology if required. The anitbodies get reported out as solid phase reactions, non-specific. A client of ours is refusing to pay for the additional work-up because they feel it is a problem with our methodology. I have argued the point that all methods have downfalls and will always have something to contend against, but they are set that it is not leagl for us to bill for this testing. I cannot really find information for either side. Really new to billing!!- so maybe I just don't know where to look for this information. Any information would be greatly appreciated.
  2. I have done much research on the matter since we were cited during our inspection this year. I recommend checking the Ask the FDA session from 2008. Question 10 tells you what the FDA determines to be "temporary" storage and then refer to the AABB standard 5.1.8.1.2- that says that the temperature shall be continuously monitored or taken every 4 hours.
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