> 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
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
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
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
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
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
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