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Record Retention


labguru

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I was wondering how other labs handle a unit of PRBC that you have to antigen type before a cross match.  We edit the unit in Meditech and put in the positive or negative result in for the antigen.  We only have a worksheet though for our reaction data. Is that worksheet something that needs to be kept for 10 years per CAP (Donor Blood Testing) or since we changed the unit and it is saved in our LIS we are ok not to save the paper worksheet?  

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It's testing to get a compatible unit for transfusion to a patient, so I would say that at the very least you would have to have a record of QC and the various lot numbers. 

As for the unit testing, it seems like you would have to keep a record of test results some sort as long as you would for any patient-related testing.  In the US that's 10 years.   Even if the data is transcribed to your computer system, the written record is primary, so you would have to save that anyway.  That's what we do here.

Scott

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We order an AGID on the unit which allows us to document the results of the unit and controls, as well as the lot number and expiration date of antisera used.  There isn't a place to document the actual control used but you could enter that in comments.  We chose to also maintain a paper log for that information, mainly so that it is easy for other shifts to see if QC has been done for that antisera for that date.  I keep that for way more than 10 years, due mainly to procrastination and lack of time/motivation to clean out our storeroom.

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We enter the units we are testing in the computer and we can enter our results. QC for antigen typing is maintained on a paper log so other techs can see that controls have been done for the day on a particular type and lot number of antisera. We don't want to waste those precious drops by having to repeat it. I keep those logs for at least a full 10 years.

On that log I have a column to indicate that the antisera was visually acceptable on the day of use and a column to write the panel lot # used for Ag controls and if the panel cells were visually acceptable. The column for panel lot # was my way of documenting that the panel performs as expected with the antisera used. This shows the panel is QC'd multiple times over the life of panel. (TRM.31234) Probably overkill but I have something documented if they ask if I QC my panel. If something didn't work right, I would hear about it!

 

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