Re: [Histonet] TC labs

2015-10-05 Thread Cert NDx via Histonet
> From: Andy B via Histonet [histonet@lists.utsouthwestern.edu] > Sent: Monday, October 05, 2015 12:47 PM > To: histonet@lists.utsouthwestern.edu > Subject: Re: [Histonet] TC labs > > Thank you. That is exactly what I would have given as an answer, but I

Re: [Histonet] TC labs

2015-10-05 Thread Kienitz, Kari via Histonet
and delete this message and its attachments from your computer system. Thank you From: Andy B via Histonet [histonet@lists.utsouthwestern.edu] Sent: Monday, October 05, 2015 12:47 PM To: histonet@lists.utsouthwestern.edu Subject: Re: [Histonet] TC labs Thank

Re: [Histonet] TC labs

2015-10-05 Thread Cert NDx via Histonet
I understand that to be the case as well. But in the case of TC only laboratories where no full report is being rendered I have yet to see any evidence that CLIA knocks on their doors. On Oct 5, 2015 4:13 PM, "Debra Siena" wrote: > If the lab performs gross examination in any way, the lab must be

Re: [Histonet] TC labs

2015-10-05 Thread Debra Siena via Histonet
They do on my lab which is TC only. Debbie Siena Sent from my iPhone On Oct 5, 2015, at 4:34 PM, Cert NDx mailto:cert...@gmail.com>> wrote: I understand that to be the case as well. But in the case of TC only laboratories where no full report is being rendered I have yet to see any evidence

Re: [Histonet] TC labs

2015-10-05 Thread Debra Siena via Histonet
If the lab performs gross examination in any way, the lab must be considered high complexity which puts the lab under the umbrella of CLIA and must be inspected every two years. Sent from my iPhone > On Oct 5, 2015, at 3:54 PM, Andy B via Histonet > wrote: > > Thank you. That is exactly wha

Re: [Histonet] TC labs

2015-10-05 Thread Andy B via Histonet
Thank you. That is exactly what I would have given as an answer, but I have yet to see any CLIA inspector or CLIA Operations manual that mentions any of that, other than the vague statements about the Lab Director ultimately being responsible. CLIA is not consistent with its rules and regulations a

Re: [Histonet] TC labs

2015-10-05 Thread Morken, Timothy via Histonet
What I believe happens is that the referring lab must do an audit/inspection of the technical-only lab to be sure they are CLIA compliant. For instance, check validation procedures for stains, equipment, quality control. It's true CLIA itself does not inspect the Tech-only lab, but the referring