Does anyone know if the FDA is still inspecting Transfusion Services every 2 years? That was the cycle we have been on for years, but it has bee 2 years and 3 months since they have been here.

We were just inspected two weeks ago. It was 2 years 4 months since the last inspection.

Hey Mary- count your blessings! Don't worry- they will show up eventually. You won't be penalized if they don't as long as you have taken care of your annual registration reporting requirements.

BC

They must have been running late this year because ours showed up about four months later than expected. They have their own schedule, but still it was four months of nail-biting and waiting for the hammer to drop. Everything went fine, but I think they were late just because they can be - they're the FDA, after all.

Did anyone else notive a huge emphasis on tissue bank requirements this time around?

I am only responsible for donor services and transfusion services, as well as HPC services. The tissue bank is under another registration. I will be happy to refer all such questions to that QA officer ;-)

BC

The FDA budget cuts translate into fewer investigators to perform inspections. It is difficult to wait but I don't think the schedule is used in a mean spirited way.

My understanding is that they don't routinely inspect transfusion services anymore, but they can come if/whenever they feel like it.

Since we stopped collecting Autologous units, and moved our registration to inactive, we have not been inspected.

We are not a large hospital, but some of the even smaller hospitals in the area may go several years without a visit.

While I don't expect them to come too often, my motto... be prepared!