[Histonet] NY State regulations

[Garrey Faller]

Check this link out from CAP.
http://www.cap.org/apps/docs/education/lapaudio/pdf/031710_qa.pdf
Scroll down to #17. It address IHC.
Garrey

On Wed, Apr 22, 2015 at 4:32 PM, Joelle Weaver <joelleweaver <@t> hotmail.com>
wrote:

> The FDA categorizes and grades each test based on the complexity of the
> test method. The FDA lists the category at
>
> *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393285.htm
> <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393285.htm>
> *on the FDA website. The FDA categorizes test methods into three levels
> of complexity:
>
> Waived complexity, Moderate Complexity, including the subcategory of
> Provider-Performed Microscopy Procedures (PPMP); and High Complexity.
>
> When categorizing a test, the FDA considers the:
>
>
>
>
>    1. Amount of interpretation involved;
>    2. Calibration and quality control requirements of the instruments
>    used;
>    3. Degree of independent judgment involved;
>    4. Difficulty of the calculations involved;
>    5. Examinations and procedures performed and the methodologies
>    employed; and
>    6. Type of training required to operate the instruments used in the
>    methodology.
>
>
> How is it determined if a test is waived, moderate or high complexity?
> For moderate and high complexity tests, the FDA evaluates each new
> commercial test system during the premarket approval process by scoring
> seven criteria as described in the CLIA regulations. The final score is
> used to determine whether the test system is classified as moderate or high
> complexity. See 42 CFR 493.17. For more details, please also see the FDA’s
> webpage on the CLIA Categorization Criteria
> <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm>[image:
> External Web Site Icon] <http://www.cdc.gov/Other/disclaimer.html> and
> CMS’ webpage on Categorization of Tests
> <http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Categorization_of_Tests.html>[image:
> External Web Site Icon] <http://www.cdc.gov/Other/disclaimer.html>.
>
> Joelle Weaver MAOM, HTL (ASCP) QIHC
>
>
>
>
>
> > From: Caroline.Pratt <@t> uphs.upenn.edu
> > To: garreyf <@t> gmail.com; gmarcella <@t> nj-urology.com
> > Date: Wed, 22 Apr 2015 19:33:35 +0000
> > Subject: RE: [Histonet] NY State regulations
> > CC: histonet <@t> lists.utsouthwestern.edu
> >
> > Just a CLIA reg, but you are correct microtomy, embedding and routine
> stains are only Moderate Complexity testing.
> >
> > -----Original Message-----
> > From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:
> histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Garreyf
> > Sent: Wednesday, April 22, 2015 3:26 PM
> > To: Gail Marcella
> > Cc: histonet <@t> lists.utsouthwestern.edu
> > Subject: Re: [Histonet] NY State regulations
> >
> > I believe grossing of small biopsies and performing ihc are both
> considered high complex testing. You must fulfill the clia personnel
> requirements of high complex testing.
> >
> > I also believe a histotech who only cuts and performs routine stains is
> not considered highly complex. I'm not sure why? Anyone know?
> >
> > Garrey
> >
> > Sent from my iPhone
> >
> > > On Apr 22, 2015, at 10:55 AM, Gail Marcella <gmarcella <@t> nj-urology.com>
> wrote:
> > >
> > > Hi - I was wondering if anyone knows the regulations regarding the NY
> State Clinical Laboratory license. I have been a Histotech and have worked
> in IHC for 20+ years and was required to obtain a NY State Clinical Lab
> License in 2007. I don't have and associates or bachelor degree and was not
> required to prior to 2007. I was told on a job interview that if I don't
> have either of these degrees that I cannot gross any specimens or run IHC.
> I've never heard this before. Has anyone else ever heard of this??? Thanks
> - Gail
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