TRM.30950 CBER notification

[Jennifer88]

We just had CAP Inspection. Although there is a policy in place for Lookback, we were cited because we did not specifically state what to do for internal deviations or unexpected events other than the hospital wide error policy. Would anyone be willing to share SOPs and forms for this? I am trying to respond to this, but I am not exactly sure what all needs to be included.

Thanks!

[jerriemc]

I have a specific blood bank policy for reporting unusual occurances. The basic policy it to file out an occuracne report on any unusual occurances including but not limited to transfusion reactions. The policy then goes into detail about reporting any fatal or potentially fatal occurances to CBER. I included how to contact CBER and what information needs to be in the report to CBER. Hope this helps.

Jerrie

[mhc]

In addition, you have to have a policy for reporting Biologic Product Deviations to CBER. This is required regardless of whether you are FDA registered/licensed or not.

[Mabel Adams]

For internal deviations we have a form that describes the situation, any patient ID involved and the MD involved. There's a space for the tech that phoned the pathologist to record what they were told. Then a space for the pathologist to sign and comment later. The form is pretty vague and we use it in the whole lab. We use it for any situation where we need the pathologist to approve a deviation (not for mistakes we find later). We use it if we need to start using a new procedure in draft form because it hasn't made it through document control in time and to give plts that expired an hour ago to a trauma patient.

[GCH LAB RAT]

We just had CAP Inspection. Although there is a policy in place for Lookback, we were cited because we did not specifically state what to do for internal deviations or unexpected events other than the hospital wide error policy. Would anyone be willing to share SOPs and forms for this? I am trying to respond to this, but I am not exactly sure what all needs to be included.

Thanks!

Hi Jennifer. I also got cited recently on TRM.30950. I have attached my procedure that I submitted to CAP for my response. Hope this helps.

Edited May 9, 2012 by GCH LAB RAT

[Jennifer88]

Thanks for all the information and ideas. I understand it better now. Now all I have to do is get it through Lab Admin and submitted to CAP!