Posted September 18, 20222 yr comment_84059 Do we have to repeat positive screening test of infectious transmitted disease from blood bag or only repeating the specimen is enough?
September 19, 20222 yr comment_84063 Is the specimen from the actual blood donation draw? Are you using serologic methods? I assume yes for these 2 questions. All reactive initial results need to be repeated in duplicate. Interpretation is based on best of 2 out of 3. For example your initial result is reactive, 2nd is reactive, but 3rd is non-reactive. You're interpretation is reactive. Then send out the donor specimen for confirmatory testing. Good luck. Edited September 19, 20222 yr by SbbPerson syntax
September 19, 20222 yr Author comment_84073 thanx for replay yes we draw from actual blood and we are using CMIA ARCHITECT for screening donors but we hosted an assessor that told us to use "another source" to repeat the test and he suggests to use a new specimen from blood bag . thats why i am asking if someone else doing this!
September 20, 20222 yr comment_84074 12 hours ago, yayani said: thanx for replay yes we draw from actual blood and we are using CMIA ARCHITECT for screening donors but we hosted an assessor that told us to use "another source" to repeat the test and he suggests to use a new specimen from blood bag . thats why i am asking if someone else doing this! Another source? Do you mean from a different blood draw? You would have to call in the patient to have the blood drawn again. But usually we don’t call patients back unless if we need more specimen or that there was a possible error in specimen processing. I am not sure why would you need another specimen from the same blood unit. You collected the specimen tubes from the initial donor draw? So the assessor wants you to draw another specimen directly from the bag after it is collected already?
September 29, 20222 yr comment_84127 Is this in case the sample tube was not actually from the donor who gave the unit? If that is possible I would have greater concerns regarding the validity of the grouping and antibody screen!
September 30, 20222 yr comment_84136 That is not a process for any regulatory agency I know of. Must be the inspector's personal opinion.
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