Re: [Histonet] IHC negative controls
We purchased a Universal Negative reagent from Ventana and then we use that in a prep kit, totally eliminating the need for Mouse and Rabbit negatives and a lot of extra space on the carousel. Shannon Gower Senior Histotechnologist HTL(ASCP) All Children’s Hospital St. Petersburg, FL (727-767-3058) ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] IHC negative controls
Happy Friday everyone! We currently have a Ventana Ultra. I am wondering what everyone is doing/running for a negative reagent control and/or a negative tissue control? Thanks in advance! Tanya Tanya G. Abbott Manager Technologist Histology/Cytology St Joseph Medical Center (phone) 610-378-2635 This email and attachments contain information that may be confidential or privileged. If you are not the intended recipient, notify the sender at once and delete this message completely from your information system. Further use, disclosure, or copying of information contained in this email is not authorized, and any such action should not be construed as a waiver of privilege or other confidentiality protections. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
Re: [Histonet] IHC negative controls
We run patient tissue as a negative and we use diluent as the reagent negative. TH Message: 7 Date: Fri, 17 Jul 2015 14:48:17 + From: Abbott, Tanya tanyaabb...@catholichealth.net To: histonet@lists.utsouthwestern.edu histonet@lists.utsouthwestern.edu Subject: [Histonet] IHC negative controls Message-ID: 852f7d2c14fb464d80e182b15db138af6b7ec...@chiex005.chi.catholichealth.net Content-Type: text/plain; charset=us-ascii Happy Friday everyone! We currently have a Ventana Ultra. I am wondering what everyone is doing/running for a negative reagent control and/or a negative tissue control? Thanks in advance! Tanya Tanya G. Abbott Manager Technologist Histology/Cytology St Joseph Medical Center (phone) 610-378-2635 This email and attachments contain information that may be confidential or privileged. If you are not the intended recipient, notify the sender at once and delete this message completely from your information system. Further use, disclosure, or copying of information contained in this email is not authorized, and any such action should not be construed as a waiver of privilege or other confidentiality protections. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] IHC negative controls
The thing is in my opinion that having the backing of CAP on this issue is a good argument to make to CLIA for why you are not doing negatives for polymer based detection IHC work, at least you will have some documentation to cover your decision. Patsy Ruegg, HT(ASCP)QIHC Ruegg IHC Consulting, LLC 40864 Arkansas Ave Bennett, CO 80102 Phone: 303-644-4538 Fax: 720-859-4110 pru...@ihctech.net -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Friday, October 26, 2012 9:45 AM To: Glen Dawson; histonet Subject: RE: [Histonet] IHC negative controls Can anyone tell me if JHACO CLIA are deferring to CAP's judgment that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Short answer: Don't bet the farm on it. Each enforces CLIA regulations but have different methods of doing so. There is no reason to think that JC or CAP will defer to the other in any particular situation. They really don't have anything to do with one another. My experience is that CAP is more lab-method oriented while JC is more total-process (patient admission to final result ) oriented. Long answer: Let's clarify this. CLIA is the law administered by the Centers for Medicare and Medicaid Services (CMS). The Joint Commission and CAP are two different, independent accrediting agencies deemed by CMS to enforce the CLIA regulations. CMS/ CLIA does not defer to CAP or JC, rather CMS deems JC and CAP to be their agent to accredit laboratories according to the CLIA law. CAP and JC cannot enforce anything without CMS/CLIA approval. The fact that CAP allows labs to leave out negative controls in certain situations may be approved by CMS/ CLIA regulators, but it does not follow that CLIA or JC inspectors will follow the same rational. JC is totally independent and can make their own interpretation of the CLIA regulations, which CMS can approve, even if they are different than what CAP allows, as long as it is within the scope of the CLIA regulations. JC can simply interpret it differently and require negative controls (I don't know if that is the case; I haven't yet looked over the new checklist this year). Tim Morken Department of Pathology UC San Francisco Medical Center -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 6:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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] IHC negative controls
Could be, but my point, maybe not clear in my answer, is that you should check with your accrediting agency before an inspection and not assume that they will follow what CAP has said it will do. Tim -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Patsy Ruegg Sent: Monday, November 05, 2012 12:56 PM To: Morken, Timothy; 'Glen Dawson'; 'histonet' Subject: RE: [Histonet] IHC negative controls The thing is in my opinion that having the backing of CAP on this issue is a good argument to make to CLIA for why you are not doing negatives for polymer based detection IHC work, at least you will have some documentation to cover your decision. Patsy Ruegg, HT(ASCP)QIHC Ruegg IHC Consulting, LLC 40864 Arkansas Ave Bennett, CO 80102 Phone: 303-644-4538 Fax: 720-859-4110 pru...@ihctech.net -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Friday, October 26, 2012 9:45 AM To: Glen Dawson; histonet Subject: RE: [Histonet] IHC negative controls Can anyone tell me if JHACO CLIA are deferring to CAP's judgment that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Short answer: Don't bet the farm on it. Each enforces CLIA regulations but have different methods of doing so. There is no reason to think that JC or CAP will defer to the other in any particular situation. They really don't have anything to do with one another. My experience is that CAP is more lab-method oriented while JC is more total-process (patient admission to final result ) oriented. Long answer: Let's clarify this. CLIA is the law administered by the Centers for Medicare and Medicaid Services (CMS). The Joint Commission and CAP are two different, independent accrediting agencies deemed by CMS to enforce the CLIA regulations. CMS/ CLIA does not defer to CAP or JC, rather CMS deems JC and CAP to be their agent to accredit laboratories according to the CLIA law. CAP and JC cannot enforce anything without CMS/CLIA approval. The fact that CAP allows labs to leave out negative controls in certain situations may be approved by CMS/ CLIA regulators, but it does not follow that CLIA or JC inspectors will follow the same rational. JC is totally independent and can make their own interpretation of the CLIA regulations, which CMS can approve, even if they are different than what CAP allows, as long as it is within the scope of the CLIA regulations. JC can simply interpret it differently and require negative controls (I don't know if that is the case; I haven't yet looked over the new checklist this year). Tim Morken Department of Pathology UC San Francisco Medical Center -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 6:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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] IHC negative controls
So true! Patsy Ruegg, HT(ASCP)QIHC Ruegg IHC Consulting, LLC 40864 Arkansas Ave Bennett, CO 80102 Phone: 303-644-4538 Fax: 720-859-4110 pru...@ihctech.net -Original Message- From: Morken, Timothy [mailto:timothy.mor...@ucsfmedctr.org] Sent: Monday, November 05, 2012 2:10 PM To: Patsy Ruegg; 'Glen Dawson'; 'histonet' Subject: RE: [Histonet] IHC negative controls Could be, but my point, maybe not clear in my answer, is that you should check with your accrediting agency before an inspection and not assume that they will follow what CAP has said it will do. Tim -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Patsy Ruegg Sent: Monday, November 05, 2012 12:56 PM To: Morken, Timothy; 'Glen Dawson'; 'histonet' Subject: RE: [Histonet] IHC negative controls The thing is in my opinion that having the backing of CAP on this issue is a good argument to make to CLIA for why you are not doing negatives for polymer based detection IHC work, at least you will have some documentation to cover your decision. Patsy Ruegg, HT(ASCP)QIHC Ruegg IHC Consulting, LLC 40864 Arkansas Ave Bennett, CO 80102 Phone: 303-644-4538 Fax: 720-859-4110 pru...@ihctech.net -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Friday, October 26, 2012 9:45 AM To: Glen Dawson; histonet Subject: RE: [Histonet] IHC negative controls Can anyone tell me if JHACO CLIA are deferring to CAP's judgment that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Short answer: Don't bet the farm on it. Each enforces CLIA regulations but have different methods of doing so. There is no reason to think that JC or CAP will defer to the other in any particular situation. They really don't have anything to do with one another. My experience is that CAP is more lab-method oriented while JC is more total-process (patient admission to final result ) oriented. Long answer: Let's clarify this. CLIA is the law administered by the Centers for Medicare and Medicaid Services (CMS). The Joint Commission and CAP are two different, independent accrediting agencies deemed by CMS to enforce the CLIA regulations. CMS/ CLIA does not defer to CAP or JC, rather CMS deems JC and CAP to be their agent to accredit laboratories according to the CLIA law. CAP and JC cannot enforce anything without CMS/CLIA approval. The fact that CAP allows labs to leave out negative controls in certain situations may be approved by CMS/ CLIA regulators, but it does not follow that CLIA or JC inspectors will follow the same rational. JC is totally independent and can make their own interpretation of the CLIA regulations, which CMS can approve, even if they are different than what CAP allows, as long as it is within the scope of the CLIA regulations. JC can simply interpret it differently and require negative controls (I don't know if that is the case; I haven't yet looked over the new checklist this year). Tim Morken Department of Pathology UC San Francisco Medical Center -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 6:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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] IHC negative controls
Very good point Linda. The only testing we currently report as an FDA approved test are our breast markers. It may be easy enough to maintain the negative in that scenario. For other scenarios, we are considering dropping the negative as long as we perform and document an extensive validation. It still may be well worth it. What do you think? -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Sebree Linda A Sent: Friday, October 26, 2012 10:24 AM To: 'Glen Dawson'; histonet Subject: RE: [Histonet] IHC negative controls Hey Glen, Don't know the answer to your specific question but on a related issue, our lab has decided to maintain running negative controls due to the fact that the manufacturer's data sheets for our IHC detection kits and a majority of our antibodies require using +/- controls. The company in question has told us they do not intend to change their guidelines as its part of the FDA approval for their products. Performing IHC staining not in compliance with the manufacturers' guidelines is against CLIA reg's. Something to consider. Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 8:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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 The information in this e-mail, and any attachments therein, is confidential and for use by the intended addressee only. If this message is received by you in error please do not disseminate or read further. Please reply to the sender that you have received the message in error, then delete the message. Although Catholic Health Services of Long Island attempts to sweep e-mail and attachments for viruses, it does not guarantee that either are virus-free and accepts no liability for any damage sustained as a result of viruses. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] IHC negative controls
I really doesn't matter what I think of course Melissa. When I presented the facts to the faculty they overwhelmingly agreed not to drop the negative controls and they were definitely not going to be in direct conflict with CLIA reg's. It's really up to your lab's manager/director whether an extensive validation is adequate. Good luck with your decision, Linda -Original Message- From: Kuhnla, Melissa [mailto:melissa.kuh...@chsli.org] Sent: Monday, October 29, 2012 5:23 AM To: Sebree Linda A; Glen Dawson; histonet Subject: RE: [Histonet] IHC negative controls Very good point Linda. The only testing we currently report as an FDA approved test are our breast markers. It may be easy enough to maintain the negative in that scenario. For other scenarios, we are considering dropping the negative as long as we perform and document an extensive validation. It still may be well worth it. What do you think? -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Sebree Linda A Sent: Friday, October 26, 2012 10:24 AM To: 'Glen Dawson'; histonet Subject: RE: [Histonet] IHC negative controls Hey Glen, Don't know the answer to your specific question but on a related issue, our lab has decided to maintain running negative controls due to the fact that the manufacturer's data sheets for our IHC detection kits and a majority of our antibodies require using +/- controls. The company in question has told us they do not intend to change their guidelines as its part of the FDA approval for their products. Performing IHC staining not in compliance with the manufacturers' guidelines is against CLIA reg's. Something to consider. Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 8:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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 The information in this e-mail, and any attachments therein, is confidential and for use by the intended addressee only. If this message is received by you in error please do not disseminate or read further. Please reply to the sender that you have received the message in error, then delete the message. Although Catholic Health Services of Long Island attempts to sweep e-mail and attachments for viruses, it does not guarantee that either are virus-free and accepts no liability for any damage sustained as a result of viruses. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] IHC negative controls
All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] IHC negative controls
Hey Glen, Don't know the answer to your specific question but on a related issue, our lab has decided to maintain running negative controls due to the fact that the manufacturer's data sheets for our IHC detection kits and a majority of our antibodies require using +/- controls. The company in question has told us they do not intend to change their guidelines as its part of the FDA approval for their products. Performing IHC staining not in compliance with the manufacturers' guidelines is against CLIA reg's. Something to consider. Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 8:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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] IHC negative controls
Can anyone tell me if JHACO CLIA are deferring to CAP's judgment that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Short answer: Don't bet the farm on it. Each enforces CLIA regulations but have different methods of doing so. There is no reason to think that JC or CAP will defer to the other in any particular situation. They really don't have anything to do with one another. My experience is that CAP is more lab-method oriented while JC is more total-process (patient admission to final result ) oriented. Long answer: Let's clarify this. CLIA is the law administered by the Centers for Medicare and Medicaid Services (CMS). The Joint Commission and CAP are two different, independent accrediting agencies deemed by CMS to enforce the CLIA regulations. CMS/ CLIA does not defer to CAP or JC, rather CMS deems JC and CAP to be their agent to accredit laboratories according to the CLIA law. CAP and JC cannot enforce anything without CMS/CLIA approval. The fact that CAP allows labs to leave out negative controls in certain situations may be approved by CMS/ CLIA regulators, but it does not follow that CLIA or JC inspectors will follow the same rational. JC is totally independent and can make their own interpretation of the CLIA regulations, which CMS can approve, even if they are different than what CAP allows, as long as it is within the scope of the CLIA regulations. JC can simply interpret it differently and require negative controls (I don't know if that is the case; I haven't yet looked over the new checklist this year). Tim Morken Department of Pathology UC San Francisco Medical Center -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Glen Dawson Sent: Friday, October 26, 2012 6:45 AM To: histonet Subject: [Histonet] IHC negative controls All, Can anyone tell me if JHACO CLIA are deferring to CAP's judgement that a negative control is not needed when utilizing a polymer detection? I assume that this is the case, but I'd like to be sure. Thank-you in advance, Glen Dawson BS, HT(ASCP), QIHC Histology Technical Specialist Janesville, WI ___ 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
