RE: [Histonet] Canned statements for ASR antibodies



I got my information from the long version of the CAP checklist that I
printed off the CAP website
Between laboratory and accreditation is an underscore line that doesn't show
up when I type it here.  Underneath the CAP question about ASR's they have
sample disclaimer information.
Here is what I use following the CAP guidelines and the inspectors have like
the completeness of it.  In fact one inspector took a copy to make sure his
labs disclaimer was as complete.  Since my last inspection though we don't
have anymore ASR's that we perform so I don't have to use it anymore.
"This test was developed and its performance characteristics determined by
[insert manufacturer].  It has not been cleared or approved by the U.S. Food
and Drug Administration. The FDA has determined that such clearance or
approval is not necessary.  This test is used for clinical purposes.  It
should not be regarded as investigational or for research.  This laboratory
is certified under the Clinical Laboratory Improvement Amendments of the
1988 (CLIA) as qualified to perform high complexity clinical laboratory
Not all of this is required, it is only recommended by CAP (see the long
version of the CAP checklist).
We only added this comment on to the surgical pathology report when doing

Hope this helps.

-----Original Message-----
From: Joe Nocito [] 
Sent: Tuesday, October 12, 2004 3:15 PM
To: Histonet
Subject: [Histonet] Canned statements for ASR antibodies

Greetings Histo land
	can anyone direct me to a web page or other "official" site to get
the wording on the immuno reagents labeled as ASR? Yep, you guessed it,
preparing for a CAP inspection and yes, this is the first time the ASR issue
came up and I know who my inspector is so this will be addressed during the
inspection. Thank you so much.
	Oh, one other thing- How Bout Them New England Patriots!!!!!!!!!!!!!

Joe Nocito, BS, HT(ASCP) QIHC
Histology Manager
Pathology Reference Lab
San Antonio, TX

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