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An article titled "Reducing the Variation in Performance of Antibody Titrations" was published in Arch Pathol Lab Med. 2008;132:1194–1201 and includes the uniform procedure. Mike -
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We would issue with 15 minutes left on the type and screen. And, per the AABB's 2010 Ask the FDA and CLIA Transcript: Question 34: The Circular of Information, for the Use of Human Blood and Blood Components, in the Instructions for Use section, item number 13 states: "Transfusion should be started before component expiration and (be) completed within 4 hours." What is the FDA's interpretation with regard to this instruction? For example, is it acceptable to start a component at 23:45 on the expiration date and allow the unit to be transfused for 4 hours (until 03:45 the next morning)? MS. CIARALDI: Our regulations in 606.122 state that administration should start within four hours of entering the product. To us, this means that transfusion must be started within the shelf life of the unit. The length of time to hang a unit, specified in the Circular of Information, is four hours. We are aware that this may sometimes result in the transfusion ending after the unit has expired; however, we do not object to this practice.
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We also have TempTrak and chose not to use it for our alarm activations. Ours is set up by Wi-Fi, so if the network goes down or there is a hiccup the temperature may not post to the server for some time, which can be hours. So, we use the refrigerator and freezer internal alarms. In testing though our facilities people were able to have a different delay for the alarms for the blood bank than what the rest of the hospital has. Ours was set to have no delay with temps posting every 5 minutes (assuming Wi-Fi data transmitted properly).
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At our facility (240 beds) our nurses are required to check the physician order on the chart when they receive the unit and are performing bedside identification of the unit with the patient.
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We purchased two of the BD 2001's and had to return them because manual washing eliminated too much of the red cells. While the footprint is large, it did work well for basic testing.
