POC.06915 – Competency Assessment Frequency (Nonwaived)

You need to challenge this deficiency with CAP.  It should be expunged.

Yes, that is what we are planning to do. Thanks.

I would challenge this also.  You also need to update the testing roaster to the personnel that are performing non-waived testing.  If they are still actively performing the test then they need to be on the list.  If they are locked out, they should not be on the list.  Do you have a written policy on how you handle this when someone is locked out?  If they were locked after the due date, they had 2 weeks to complete testing.  If they didn't, I removed them from the CAP list and they had to start all over with initial, 6 months and yearly.  It was really hard at first when I put this into place, however it did catch on and they started to comply.
 

Challenge it. Don't stress about it. If the inspector cites you for something that you disagree with, politely explain your situation but if they don't agree, smile and write to CAP to challenge it. 

I agree you should challenge this since you have her locked out immediately past her due date.  We have similar scenarios and if they miss their 6 month they get locked out and have to start at initial training and the timeline begins all over.  I think the inspector is confusing training versus competency.  You should have her training documentation that shows exactly what has been covered and the competency that requires the 6 elements. 

 Thank you for your kind words and thoughtful suggestions. I was quite stressed afterward and didn’t sleep at all that night. We put so much effort into our work, and POC is such a large area outside of the core lab, involving a large group of testing personnel and many different test systems, not only manage the reagent, instruments, patient results but also all the training and competencies. In order to meet compliance and high standard of patient care, we do contribute lots of the effort.    

Confident this will be expunged. The reg states "the competency of personnel performing nonwaived testing...". Locked out = not performing.
I like what you are doing Sharon and will try to implement something similar. Many users on FMLA leaves, maternity leave, etc.

In the scenario of missed competency, I have the lab fill out a deviation/NCE form.  The form serves as documentation that 1. the lab recognized the non-compliant issue and 2. what the corrective action was. In your case, the corrective action was to remove the testing personnel from the active roster for that test.  

I agree that you should challenge this and also agree about updating the testing roster as that should help in the future.  Best of luck!

Agree with all suggestions.

Because we also use RALS, I'm wondering if the very tiny point about the operator being 'active' (vs 'having been 'deactivated') in RALS database was the issue, although why an inspector would not SAY at the time seems unfair to me.

I'll use an example I infrequently encounter - in RALS - to explain what you may want to consider, if you have not yet. Example: operator Jane ('active' in RALS) has been performing 2 POCT connected and no issues keeping up comp assessments for years. Jane transfers to a testing site where she only has to perform 1 of those 2 POCTs. Once the POCT she no longer performs 'expires competency', she shows up on the 'expired' list in RALS (eg if you were asked to print or show inspector 'who is expired/past comp date', she'd be on that list if default is 'active' operators).

At least for us, and I do not know if this can be a different setting or not, I must delete the instrument no longer needed because I cannot 'deactivate' just one instrument access. Deactivating removes the entire account of the operator out as not active (operators cannot be 'deleted' out of RALS, we 'deactivate'). At the time an 'expired competency' operator does check-off for a new or renew/get trained again per policy after a lapsed competency, that instrument is added into their RALS operator account.

Good Luck with the challenge and please keep us posted!

were you able to provide the initial training/competency paper to the inspector?