I was wondering if anyone knows if there is a regulatory agency that would be involved in a hospital system consolidating antibody identification (Reference work-but not as involved as those that would be sent to an IRL). For example if there are 5 hospitals in a system, one hospital would be sent all antibody work-ups or all work-ups that a sister hospital couldn't resolve. Also is there a regulation on sending samples like that to another hospital?

 

I don't know if I'm looking in the wrong places, but I couldn't find anything with FDA and it seems like AABB IRL is optional enrollment but not required.

 

 

I am not aware of any regulatory issues.  I think if you all follow the same SOPs and you have established methods of shipping samples between sites you should be OK.  You may want to have an SOP describing your "reference lab" process --who does what, when etc.  

I THINK I am correct in saying that this sort of thing goes on in Seattle under Dr. Jim Aubuchon, but I could be wrong.

 

It is certainly the sort of "hub and spoke" model that is being introduced into the UK.

We perform testing for two hospitals.  FDA required we have a 'contract' on file with them ... that is all.

We do some of this within our system. As long as it is within system I know of no issues. We can go ahead and result what we get because it is a shared computer system. We are also CAP inspected as a system . The 2 facilities that are AABB inspected are done as a system and the other 2 will get AABB next year and then will be part of that system inpsecton in the future.

We do advanced workups for other hospitals - they are required to have our CLIA license number on file as a reference lab.  The FDA has never commented on the need for a contract.