For AABB standard 6.2.4 I am seeking guidance on what is meant by Records shall be created and maintained to include: 5) Method(s) used (when more than one method is in use).

 

How does AABB define methods.  I work for a hospital system and we are currently merging many of our practices.  Some facilities consider methods to be instrument v. manual.  Some facilities believe manual tests such as manual gel and manual tube testing would be different methods.  I am just trying to get a feel for how organizations define and practice this. 

 

Thanks for your help in advance.

 

 

I consider all of the following to be different methods: manual tube, manual gel,PEG, enzyme, solid-phase, ProVue, Galileo, Echo, Tango, Immune Rosetting Test kits, Kleihauer-Betke Staining kits.

When we do our method comparisons we compare LISS tube testing, Peg tube testing, manual gel, and automated solid phase (Tango).

I work in the UK, so we are not governed by AABB 6.2.4, but what I would say is, why have different methods available, if you expect EXACTLY the same results from each (e.g. LISS tube, PEG tube, NISS tube, etc). If that were the case, then you are just duplicating your work.

If, on the other hand, you have different methods available because you DO NOT expect EXACTLY the same results from each (e.g. one is better at detecting this, another is better at detecting that, one does not detect what I would call "rubbish reactions"), then I would have thought that recording the technique used is essential.

Right, Malcolm.  I would think that the point of the reg is that for a given test performed, the regulator wants to know how it was done.  If you have only one method for, say, an antibody ID, all you have to do is point them to your procedure.  But with multiple methods, there is no way to tell which was used, unless there is some documentation.  So if you use say, gel or tube for an antibody screen, you need to indicate which one is being used.  In general, I would think this would not be that big of a deal with most BB systems.

 

Scott

I agree with Dansket. I would call any "process" that produces a result with  steps that are different from another "process" to be a different method

Thanks for the input thus far.  I did email AABB for a definition so if I get a response from them I will share on this thread as well. 

If I am doing a workup on a patient and looking at the old records I really want to know what technique was used to get the results.