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 <joellewea...@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.pr...@uphs.upenn.edu > > To: garr...@gmail.com; gmarce...@nj-urology.com > > Date: Wed, 22 Apr 2015 19:33:35 +0000 > > Subject: RE: [Histonet] NY State regulations > > CC: histonet@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-boun...@lists.utsouthwestern.edu [mailto: > histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Garreyf > > Sent: Wednesday, April 22, 2015 3:26 PM > > To: Gail Marcella > > Cc: histonet@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 <gmarce...@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 > > > _______________________________________________ > > > Histonet mailing list > > > Histonet@lists.utsouthwestern.edu > > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > > > _______________________________________________ > > Histonet mailing list > > Histonet@lists.utsouthwestern.edu > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > > > _______________________________________________ > > Histonet mailing list > > Histonet@lists.utsouthwestern.edu > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet