[Histonet] ASR Disclaimer

Angela Bitting akbitting <@t> geisinger.edu
Thu Feb 10 14:13:46 CST 2005

We are currently involved in adding this to our reports as well. One
example that I think is very good comes from University of Pittsburgh
Medical System.
It reads: 
   "The following statement applies to all Immunohistochemistry, in-situ
Hybridization Assays (ISH & FISH), and Immunofluorescent Testing:

 The testing was developed and its performance characteristics
determined by the University of Pittsburgh, Department of Pathology, as
required by CLIA '88 regulations. The testing has not been cleared or
approved for the specific use by the U.S. Food and Drug Administration,
but the FDA has determined such approval is not necessary for clinical

 We tried putting a disclaimer on our Molecular Path reports last year,
and one payor kept rejecting the billing because that disclaimer used
the word "Research". So, I suggest it is best to avoid the use of that
word if possible.

Angela Bitting, HT(ASCP)
Technical Specialist, Histology
Geisinger Medical Center 
100 N Academy Ave. MC 23-00
Danville, PA 17822
phone  570-214-9634
fax  570-271-5916

>>> "Kevin Briggs" <BriggsK <@t> drmc.drhsi.org> 02/10/05 02:23PM >>>
Hi Netters!

    I am curious to know how other laboratories are handling the CAP
Checklist item ANP.12425: "If patient testing is performed using Class I
analyte-specific reagents (ASR's) obtained or purchased from an outside
vendor, does the patient report include the disclaimer required by
federal regulations?"  I am specifically searching for examples of
canned text comments or disclaimers suitable for reporting any of our
antibodies simultaneously.


Kevin D. Briggs, MS, CT(ASCP)
Team Leader- Cytopathology/ Histopathology Services
Danville Regional Medical Center
142 South Main Street
Danville, VA 24541
Telephone: (434) 799-4470 ext.5451
Fax: (434) 799-2118
E-mail: briggsk <@t> drhsi.org

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