RE: [Histonet] NY State regulations
Probably CLIA related to high complexity testing. IHC is not considered under CLIA ( from 1988), though many people feel otherwise. Grossing is. I think that it is under sub part G or H if I remember correctly. Joelle Weaver MAOM, HTL (ASCP) QIHC From: gmarce...@nj-urology.com To: histonet@lists.utsouthwestern.edu Date: Wed, 22 Apr 2015 10:55:19 -0400 Subject: [Histonet] NY State regulations 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
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
RE: [Histonet] NY State regulations
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
RE: [Histonet] NY State regulations
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.pr...@uphs.upenn.edu To: garr...@gmail.com; gmarce...@nj-urology.com Date: Wed, 22 Apr 2015 19:33:35 + 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
Re: [Histonet] NY State regulations
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 + 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
