Hello -

I'm wondering how other facilities are handling who signs into the LIS when training is taking place? Is it the trainer or trainee? I was recently informed that if the trainee is logged in under the trainers credentials it is a violation of 21 CFR part 11.

Thanks,

Amy

At our facility, the Trainee has their own log in.  The Trainer is responsible for assuring that all results are entered correctly.  Should something be wrong, we would hold both responsible.

Everybody gets a unique login, here (students and new employees) and only results under their own login.

In blood bank, we go the extra step to put "reviewed by:___" comments on all of our students' work.

21 hours ago, Kelly Guenthner said:

Everybody gets a unique login, here (students

Our students are not allowed to do anything in the computer in our BB - they just watch that part.

New Employees - yes, they get their own log in.

At our hospital...

New employees (who are licensed) training can enter and verify results under their own log in.

Unregistered technologists (haven't received their license yet) and students may be able to log in to the LIS and enter results but they are unable to verify results.  That must be done under the supervising MLT's log in.  So they either review/result or it is done under the MLT's login under supervision.  

sandra