[Histonet] Light/Heavy chain Myosin to differentiate Type 1 vs Type 2 muscle fibers
Good morning Histonet, We are looking for a reference lab to send FFPE slides to for the above antibody(ies). We sent out for this test several years ago but of course at that time our records were very rudimentary, i.e. log books, so difficult to go back and search through. Hope someone knows something to help us. Thanks, Linda A. Sebree University of Wisconsin Hospital Clinics IHC/ISH Laboratory 600 Highland Ave. Madison, WI 53792 (608)265-6596 FAX: (608)262-7174 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Histotech Position -DALLAS, TX
We are a large digestive health histology laboratory in Dallas, TX. We are looking for either an experienced tech or a recent college grad with a science degree to train. Hours are 7am - 3:30 pm. Competitive benefits and salary. Please email your resume to cory.coll...@dhat.commailto:cory.coll...@dhat.com. Thanks, Cory Cory Collins, HT (ASCP), QIHC P: 214-442-5805 F: 214-442-5806 This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the sender and delete this message from your system. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the company. Finally, the recipient should check this email and any attachments for the presence of viruses. Digestive Health Management/Digestive Health Associates of Texas accepts no liability for any damage caused by any virus transmitted by this email. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] Mohs
On fatty tissue, especially cheeks. After we mount on a slide we spray the tissue with liquid nitrogen and let sit to freeze before embedding for a couple of minutes. Than after embedding spray the chuck again with liquid nitrogen. On really fatty stuff you may have to freeze before cutting each time. Time consuming yes. But I find freezing and let sitting I don't fight with it as much when cutting. Anne -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of michele carr Sent: Tuesday, September 23, 2014 9:00 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Mohs Hello I perform mohs cutting a few days a week and I noticed that on fatty skin tissue I don't get the interior of the skin section. I only seem to get the epidermis. Is there a trick to getting the fatty tissue too. I tried bumping up the microns but that only helped a bit. Thanks for your responses. Michele Carr ___ 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] RELIA Histology Careers Bulletin 9/24/2014 Are you ready for Fall?
Hello Histonetters!! How are you? Are you enjoying the sights, sounds and flavors of Fall? I know I am enjoying college football after all I am a southern gal and you know how we southerners are about our Football Saturdays in the South. On the other hand I am still patiently waiting for that real Fall stuff. You know like crisp cool air, beautiful fall colors, crunching leaves and steaming bowls of soup. Because it is still 90 degrees here in Orlando What are you enjoying most of all about this season? I also wanted to tell you about some new job opportunities. These are some of my best clients and they are ready to interview and hire right away. HOT HISTOLOGY OPENINGS: AP Manager - East of Chicago Dermpath Histotech - Fayetteville, AR Histotechnologist - Philadelphia area Histotechnician - Modesto, CA Histotechnician - Mountain View, CA Senior/Lead Histotech - St. Louis Histotech - Norfolk, VA Histotech - Williamsburg, VA If you are interested in participating in my referral program in addition to these histology openings I also need cytotechs in NC and LA. If you or anyone you know might be interested in any of these opportunities or would like help with a job search in another area of the USA please contact me. I can be reached at rel...@earthlink.net or toll free at 866-607-3542. Thanks-Pam Right Place, Right Time, Right Move with RELIA! Thank You! Pam M. Barker Pam Barker President/Senior Recruiting Specialist-Histology RELIA Solutions Specialists in Allied Healthcare Recruiting 5703 Red Bug Lake Road #330 Winter Springs, FL 32708-4969 Phone: (407)657-2027 Cell: (407)353-5070 FAX: (407)678-2788 E-mail: rel...@earthlink.net www.facebook.com http://www.facebook.com/PamBarkerRELIA /PamBarkerRELIA www.linkedin.com/in/reliasolutions www.twitter.com/pamatrelia ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Floor Tiles
Our entire lab, including histology, has linoleum flooring. We cover areas with non-skid mats as necessary. We will be renegotiating our lease shortly and are considering having the building management company replace the flooring. Are there are any recommendations for a superior, non-slip, easy to clean and maintain flooring for the lab, particularly histology? Thanks, Lester J. Raff, MD MBA UroPartners Medical Director Of Laboratory 2225 Enterprise Dr. Suite 2511 Westchester, Il 60154 Tel: 708-486-0076 Fax: 708-492-0203 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] H.Pylori Control/AFP
Does anyone have any h-pylori control blocks they would like to share? Also looking for AFP...Willing to trade:) We have many other kinds of tissue...Just running short on those Thanks Kristi Langley HT(ASCP) Converge Dx. Peabody, Mass. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Gram stain not working consistently: how likely is it that crystal violet has gone bad
Dear Histoneters: If Gram stains are not always working consistently: how likely is it that crystal violet has gone bad. My first suspect is the decoloration step, then age of the culture, then thickness of the smear. However, I do not want to disregard any possibility, such as bad reagents. Please, email any feedback directly to me, blayjo...@gmail.com. Cheers and gracias, Jorge Jorge A. Santiago-Blay, PhD blaypublishers.com http://blayjorge.wordpress.com/ http://paleobiology.si.edu/staff/individuals/santiagoblay.html ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
Re: [Histonet] H.Pylori Control/AFP
HP is difficult, we actually use a patien control from a positive case and cut approx 20 slides from each block. You can probably purchase them but they are costly. Sue Paturzo TJUH ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Floor Tiles
I don't think the ideal exists. Anything that is flat is going to have some slip issues, though the right floor wax can help, and maybe those peel-off sticky mats to catch dirt/paraffin. We have a vinyl tile floor that has a grid pattern embossed into it - 1 squares. It is pretty much non-slip, but wax cannot be scraped off easily because of the embossed indentations. We need housekeeping to do some serious machine stripping and rewaxing every two weeks to clean it. Tim Morken Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies UC San Francisco Medical Center San Francisco, CA CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Lester Raff MD Sent: Wednesday, September 24, 2014 8:43 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Floor Tiles Our entire lab, including histology, has linoleum flooring. We cover areas with non-skid mats as necessary. We will be renegotiating our lease shortly and are considering having the building management company replace the flooring. Are there are any recommendations for a superior, non-slip, easy to clean and maintain flooring for the lab, particularly histology? Thanks, Lester J. Raff, MD MBA UroPartners Medical Director Of Laboratory 2225 Enterprise Dr. Suite 2511 Westchester, Il 60154 Tel: 708-486-0076 Fax: 708-492-0203 ___ 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] RE: Floor Tiles
We have really old floor tiles and do not allow Housekeeping to wax them with anything that would be slippery. They use a non-skid wax only if they use anything. Pam Marcum -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Wednesday, September 24, 2014 11:44 AM To: 'Morken, Timothy'; 'Lester Raff MD'; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Floor Tiles We have a non wax floor. It's a flat surface and easy to clean. Hazel Horn Supervisor of Histology/Autopsy/Transcription Anatomic Pathology Arkansas Children's Hospital 1 Children's Way | Slot 820| Little Rock, AR 72202 501.364.4240 direct | 501.364.1241 fax hor...@archildrens.org archildrens.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Wednesday, September 24, 2014 11:40 AM To: 'Lester Raff MD'; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Floor Tiles I don't think the ideal exists. Anything that is flat is going to have some slip issues, though the right floor wax can help, and maybe those peel-off sticky mats to catch dirt/paraffin. We have a vinyl tile floor that has a grid pattern embossed into it - 1 squares. It is pretty much non-slip, but wax cannot be scraped off easily because of the embossed indentations. We need housekeeping to do some serious machine stripping and rewaxing every two weeks to clean it. Tim Morken Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies UC San Francisco Medical Center San Francisco, CA CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Lester Raff MD Sent: Wednesday, September 24, 2014 8:43 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Floor Tiles Our entire lab, including histology, has linoleum flooring. We cover areas with non-skid mats as necessary. We will be renegotiating our lease shortly and are considering having the building management company replace the flooring. Are there are any recommendations for a superior, non-slip, easy to clean and maintain flooring for the lab, particularly histology? Thanks, Lester J. Raff, MD MBA UroPartners Medical Director Of Laboratory 2225 Enterprise Dr. Suite 2511 Westchester, Il 60154 Tel: 708-486-0076 Fax: 708-492-0203 ___ 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 contained in this message may be privileged and confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to the message and deleting it from your computer. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet -- Confidentiality Notice: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is
[Histonet] FT NIGHT SHIFT DELRAY BEACH FL
Hi Histonetters! We are looking for a full time licensed histotech here in our very busy Delray Florida Dermatology Lab. This is a permanent full time NIGHT SHIFT (40 hours) position with benefits (medical/401k/vacation) and shift differential. THIS IS A DRUG FREE WORKPLACE. ***PLEASE NO HEAD HUNTERS/PLACEMENT SERVICES***!!! Email your resume to lengim...@leavittmgt.commailto:lengim...@leavittmgt.com if interested. *full time position Mon-Fri PM (will discuss hours upon interview/will be AFTER 5p) *MUST be licensed as a FL histotechnologist or technician *MUST have at LEAST 2 years experience (dermatology preferred) Please DO NOT respond if no EXPERIENCE! *VERY proficient in embedding and microtomy *must be self motivated, reliable and a team player *knowledge in operating Ventana and Leica equipment desired (not necessary) Kari M Simeone 561.819.6517 fax ksime...@leavittmgt.commailto:ksime...@leavittmgt.com www.advancedderm.comhttp://www.advancedderm.com/ The information contained in this message and any attachments is intended only for the use of the individual or entity to which it is addressed, and may contain information that is privileged, confidential and exempt from disclosure under applicable law. If you have received this message in error, you are prohibited from copying, distributing or using the information. Please contact the sender immediately by return e-mail and delete the original message. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Histonet Digest, Vol 130, Issue 24
1. Our AP critical report list includes: frozen section diagnosis, gross intra-operative consult, intra-operative cytology for immediate assessment, cytology FNA immediate evaluation, new malignancies, major amended reports, inadequate specimens or empty containers, unusual or unexpected findings (these are also defined), clinical history and procedure do not match. Our pathologists always make note of date/time/who they talked to/topic Documented within the body of the report. Sincerely, Terri Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 Today's Topics: 1. Surgical Pathology reports (Lake,Debbie) Message: 1 Date: Tue, 23 Sep 2014 17:22:35 + From: Lake,Debbie debbie.l...@mgh.net Subject: [Histonet] Surgical Pathology reports Do pathologists ever call pathology reports to a physician? If so, what types of diagnoses do they call? There are no critical test results in Pathology that CAP deems necessary to call as in other areas of the laboratory.. How do others handle this? Debra Lake MT(ASCP) Manager Micro, Blood Bank, Pathology Marion General Hospital Marion, IN 46952 (765) 660-6521 Fax: (765-651-7330) * - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] FDA Disclaimer
To All: We are starting up IHC at the lab and I have a question about disclaimer. If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports? And if so, what should it say? Karla Arrington =) Karla Arrington, HT(ASCP), HIT(AHIMA) Lead Histology Technician ANMC Pathology 907-729-1810 kaarring...@anthc.org ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: FDA Disclaimer
Karla, the thing is, they may be called IVD under FDA nomenclature, but they are not all FDA approved. Class I exempt antibodies (the vast majority) don't need FDA approval because they are ancillary tests used in conjunction with other tests to arrive at a Dx. Only stand-alone tests like ER, Pr, Her2 and EGFR are in Class II and require FDA approval. An FDA certified company can list any antibody (except the stand alones) as IVD Class I simply by submitting a list to FDA. The company must have FDA approved quality controls in place and follow a slew of regulations to do so, but it is simply a paperwork exercise after that. So, the disclaimer you mention says that the antibody in question is not FDA approved, but is not required to be FDA approved. The CAP and ASCP suggested this disclaimer so that customers would be made to understand that although the tests are not under FDA approval it does not mean they are not valid tests. Tim Morken Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies UC San Francisco Medical Center San Francisco, CA CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Arrington, Karla A Sent: Wednesday, September 24, 2014 10:44 AM To: 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] FDA Disclaimer To All: We are starting up IHC at the lab and I have a question about disclaimer. If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports? And if so, what should it say? Karla Arrington =) Karla Arrington, HT(ASCP), HIT(AHIMA) Lead Histology Technician ANMC Pathology 907-729-1810 kaarring...@anthc.org ___ 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] RE: FDA Disclaimer
Tim has aleady supplied alot of information here. When I needed the disclaimer, I used the language and wording directly from the ANP checklist placed in quotations within the reports when I put together the basic templates in LIS. Depending on your system, you might be able to link it to the test mneumonic or other means to drop it in automatically when this test is ordered or reported in the final pathology report. Joelle Weaver MAOM, HTL (ASCP) QIHC From: timothy.mor...@ucsfmedctr.org To: kaarring...@anthc.org; histonet@lists.utsouthwestern.edu Date: Wed, 24 Sep 2014 18:24:11 + CC: Subject: [Histonet] RE: FDA Disclaimer Karla, the thing is, they may be called IVD under FDA nomenclature, but they are not all FDA approved. Class I exempt antibodies (the vast majority) don't need FDA approval because they are ancillary tests used in conjunction with other tests to arrive at a Dx. Only stand-alone tests like ER, Pr, Her2 and EGFR are in Class II and require FDA approval. An FDA certified company can list any antibody (except the stand alones) as IVD Class I simply by submitting a list to FDA. The company must have FDA approved quality controls in place and follow a slew of regulations to do so, but it is simply a paperwork exercise after that. So, the disclaimer you mention says that the antibody in question is not FDA approved, but is not required to be FDA approved. The CAP and ASCP suggested this disclaimer so that customers would be made to understand that although the tests are not under FDA approval it does not mean they are not valid tests. Tim Morken Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies UC San Francisco Medical Center San Francisco, CA CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Arrington, Karla A Sent: Wednesday, September 24, 2014 10:44 AM To: 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] FDA Disclaimer To All: We are starting up IHC at the lab and I have a question about disclaimer. If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports? And if so, what should it say? Karla Arrington =) Karla Arrington, HT(ASCP), HIT(AHIMA) Lead Histology Technician ANMC Pathology 907-729-1810 kaarring...@anthc.org ___ 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] RE: Unsubscribe me please
Hi Robert, You must do that at http://lists.utsouthwestern.edu/mailman/listinfo/histonet Thanks and best wishes! Joyce Weems Pathology Manager 678-843-7376 Phone 678-843-7831 Fax joyce.we...@emoryhealthcare.org www.saintjosephsatlanta.org 5665 Peachtree Dunwoody Road Atlanta, GA 30342 This e-mail, including any attachments is the property of Saint Joseph's Hospital and is intended for the sole use of the intended recipient(s). It may contain information that is privileged and confidential. Any unauthorized review, use, disclosure, or distribution is prohibited. If you are not the intended recipient, please delete this message, and reply to the sender regarding the error in a separate email. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Robert Fauck [CCDHB] Sent: Wednesday, September 24, 2014 4:28 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Unsubscribe me please Hi Could you please unsubscribe me from your Histo-List. Thanks Robert Fauck This email or attachment(s) may contain confidential or legally privileged information intended for the sole use of the addressee(s). Any use, redistribution, disclosure, or reproduction of this message, except as intended, is prohibited. If you received this email in error, please notify the sender and remove all copies of the message, including any attachments. Any views or opinions expressed in this email (unless otherwise stated) may not represent those of Capital Coast District Health Board. http://www.ccdhb.org.nz (1C_S1) ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet This e-mail message (including any attachments) is for the sole use of the intended recipient(s) and may contain confidential and privileged information. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this message (including any attachments) is strictly prohibited. If you have received this message in error, please contact the sender by reply e-mail message and destroy all copies of the original message (including attachments). ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Unsubscribe me please
Hi Could you please unsubscribe me from your Histo-List. Thanks Robert Fauck This email or attachment(s) may contain confidential or legally privileged information intended for the sole use of the addressee(s). Any use, redistribution, disclosure, or reproduction of this message, except as intended, is prohibited. If you received this email in error, please notify the sender and remove all copies of the message, including any attachments. Any views or opinions expressed in this email (unless otherwise stated) may not represent those of Capital Coast District Health Board. http://www.ccdhb.org.nz (1C_S1) ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: FDA Disclaimer
Well put Tim. Linda A. Sebree University of Wisconsin Hospital Clinics IHC/ISH Laboratory 600 Highland Ave. Madison, WI 53792 (608)265-6596 FAX: (608)262-7174 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Wednesday, September 24, 2014 1:24 PM To: 'Arrington, Karla A'; 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] RE: FDA Disclaimer Karla, the thing is, they may be called IVD under FDA nomenclature, but they are not all FDA approved. Class I exempt antibodies (the vast majority) don't need FDA approval because they are ancillary tests used in conjunction with other tests to arrive at a Dx. Only stand-alone tests like ER, Pr, Her2 and EGFR are in Class II and require FDA approval. An FDA certified company can list any antibody (except the stand alones) as IVD Class I simply by submitting a list to FDA. The company must have FDA approved quality controls in place and follow a slew of regulations to do so, but it is simply a paperwork exercise after that. So, the disclaimer you mention says that the antibody in question is not FDA approved, but is not required to be FDA approved. The CAP and ASCP suggested this disclaimer so that customers would be made to understand that although the tests are not under FDA approval it does not mean they are not valid tests. Tim Morken Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies UC San Francisco Medical Center San Francisco, CA CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Arrington, Karla A Sent: Wednesday, September 24, 2014 10:44 AM To: 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] FDA Disclaimer To All: We are starting up IHC at the lab and I have a question about disclaimer. If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports? And if so, what should it say? Karla Arrington =) Karla Arrington, HT(ASCP), HIT(AHIMA) Lead Histology Technician ANMC Pathology 907-729-1810 kaarring...@anthc.org ___ 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] New Artisan Gram stain kits
Hello there you awesome group of histo gurus... We have been running the new improved Artisan Gram kits. They say to use the standard on board staining protocol. This gives us no gram+ orgs. We reset the CV to its max. Still no blue. We used the same new kit reagents manually with the same instrument timings. Perfect results!! Tried to decrease the on board decolorisation step. Nothing. So for now we do them all manually. Hope someone out there has some wise words for me. Greetings from the sandpit Annie (still from, but not IN, Africa) Sent from my iPhone ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
