[Histonet] RE: FDA Disclaimer

[Joelle Weaver]

Tim has aleady supplied alot of information here.  When I needed the disclaimer, I used the language and wording  directly from the ANP checklist placed in quotations within the reports when I put together the basic templates in LIS. Depending on your system, you might be able to link it to the test mneumonic or other means to drop it in automatically when this test is ordered or reported in the final pathology report. 
       


Joelle Weaver MAOM, HTL (ASCP) QIHC

        
  

 
> From: Timothy.Morken <@t> ucsfmedctr.org
> To: kaarrington <@t> anthc.org; histonet <@t> lists.utsouthwestern.edu
> Date: Wed, 24 Sep 2014 18:24:11 +0000
> CC: 
> Subject: [Histonet] RE: FDA Disclaimer
> 
> Karla, the thing is, they may be called "IVD" under FDA nomenclature,  but they are not all FDA "approved." Class I exempt antibodies  (the vast majority) don't need FDA "approval" because they are ancillary tests used in conjunction with other tests to arrive at a Dx.  Only stand-alone tests like ER, Pr, Her2 and EGFR are in Class II and require FDA approval.
> 
> An FDA certified company can list any antibody (except the stand alones) as IVD Class I simply by submitting a list to FDA. The company must have FDA approved quality controls in place and follow a slew of regulations to do so, but it is simply a paperwork exercise after that. 
> 
> So, the disclaimer you mention says that the antibody in question is not FDA approved, but is not required to be FDA approved. The CAP and ASCP suggested this disclaimer so that customers would be made to understand that although the tests are not under FDA approval it does not mean they are not valid tests. 
> 
> Tim Morken
> Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
> UC San Francisco Medical Center
> San Francisco, CA
> 
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> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Arrington, Karla A
> Sent: Wednesday, September 24, 2014 10:44 AM
> To: 'histonet <@t> lists.utsouthwestern.edu'
> Subject: [Histonet] FDA Disclaimer
> 
> To All:
> 
> We are starting up IHC at the lab and I have a question about disclaimer.
> 
> If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports?
> And if so, what should it say?
> 
> Karla Arrington =)
> 
> Karla Arrington, HT(ASCP), HIT(AHIMA)
> Lead Histology Technician
> ANMC Pathology
> 907-729-1810
> kaarrington <@t> anthc.org
> 
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