CMS 209 (laboratory personnel report - CLIA) form and TJC

We have the form all filled out and done. My question is more, what does TJC do with this form? do they review it at the beginning? is this a reference at all times? do they ask for it?

Juan,

the CMS-209 form was itemized as a document by TJC on our most recent survey as one that was to be available on Day-1 of our survey.  Our inspector reviewed the job classification of each of our employees listed (Technical Supervisor, Technical Consultant, General Supervisor, etc) and verified that our classification was correct on some of those itemized.

With that document we also maintain a listing of "delegated" tasks within the lab (who can review and sign off on specific documents, etc)  Our surveyor wanted to see a signed copy of that delegation approved by our Medical Director.  You do not need to include staff who only perform waived testing, only moderate and high complexity.

Hi, perhaps because we are TJC for waived only and the clinics are surveyed during CAMH hospital and system inspection, I have not been asked for the form by a survey team. However, I attended an excellent talk by Elia Mears, TJC inspector, at the AACC annual conference in Anaheim and she mentioned this form several times and said she asks for it and reviews it with leadership.

Good Luck.

Gregory,

Thank you so much for that information! a couple follow up questions. Did you use the "official" form? We are finding it to be cumbersome as it only provides 15 or so lines per form. Did you use a separate line for individuals performing more than one CLIA position, if so we have the form suffice only a few people.

Thank you again for your help!

Juan

Hi Peggy,

Thank you! I hope all is well and I was at that talk at AACC as well.

Juan