[Histonet] NY State regulations

[Joelle Weaver]

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 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:




Amount of interpretation involved;
Calibration and quality control requirements of the instruments used;
Degree of independent judgment involved;
Difficulty of the calculations involved;
Examinations and procedures performed and the methodologies employed; and
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 and CMS’ webpage on Categorization of Tests.


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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