[Histonet] influenza IHC
I was approached by one of my pathologist with this question. Does anyone perform influenza IHC?? Contact me if you do or have any info referencing that specific testing ability. Toni McDaniel-Martin Forensic Histotech Specialist HT, ACSP University of Louisville Forensic Pathology 810 Barrett Ave Louisville KY 40204 Office: 502-852-5587 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: influenza IHC
Email Dr. Richard Cartun He specializes in infectious disease IHC. richard.car...@hhchealth.org Amanda Kelley -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of McDaniel, Toni (Justice) Sent: Tuesday, January 13, 2015 12:54 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] influenza IHC I was approached by one of my pathologist with this question. Does anyone perform influenza IHC?? Contact me if you do or have any info referencing that specific testing ability. Toni McDaniel-Martin Forensic Histotech Specialist HT, ACSP University of Louisville Forensic Pathology 810 Barrett Ave Louisville KY 40204 Office: 502-852-5587 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet The materials in this email are private and may contain Protected Health Information. If you are not the intended recipient, be advised that any unauthorized use, disclosure, copying, distribution or the taking of any action in reliance on the contents of this information is strictly prohibited. If you have received this email in error, please immediately notify the sender via telephone or return email. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Re: Block counts
Good morning! I agree with some of the other comments - per day is too variable because of tissue type, overall volume, etc. We use hourly average to try to keep everyone in the same range but still leave room for individual abilities. Erin Erin Martin, Histology Supervisor UCSF Dermatopathology Service 415-353-7248 Confidentiality Notice The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or priviledged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you receive this in error, please contact the sender and delete the material from any computer. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
Re: [Histonet] Re: Block counts
I agree- we use the product as the measure: slides for microtomy, specimens/hr for gross, etc. Michael Ann Jones, HT (ASCP) Histology Manager Metropath 7444 W. Alaska Dr. #250 Lakewood, CO 80226 303.634.2511 mjo...@metropath.com On 1/13/15, 7:13 AM, Martin, Erin erin.mar...@ucsf.edu wrote: Good morning! I agree with some of the other comments - per day is too variable because of tissue type, overall volume, etc. We use hourly average to try to keep everyone in the same range but still leave room for individual abilities. Erin Erin Martin, Histology Supervisor UCSF Dermatopathology Service 415-353-7248 Confidentiality Notice The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or priviledged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you receive this in error, please contact the sender and delete the material from any computer. ___ 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] THICK AND THIN SECTIONS ?
If you are using one of the following microtomes and the advance mechanism is worn out. ( too much play between spindle and spindle nut ) REICHERT/JUNG 2030 LEICA RM 2125 LEICA 2030 Biocut LEICA/JUNG2035 LEICA - CM 1850 Cryostat SAKURA SRM200 You could be faced with purchasing a new Microtome. ( No parts availability ) Rather than replacing these excellent Instruments, I have a PERMANENT solution to fix this problem. For Information, contact: Klaus Dern Phone: 706 635-8840 E-Mail: klaus.der...@gmail.com ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] Block Counts
I have never really cared how fast or how many blocks can be embedded or cut per hour. I have always focused on the quality. In a hospital setting there is too much variety to have set numbers. Tom Podawiltz HT (ASCP) Histology Section Head LRGHealthcare Laconia, NH 03246 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of WILLIAM DESALVO Sent: Monday, January 12, 2015 6:18 PM To: Morken, Timothy Cc: histonet@lists.utsouthwestern.edu; Goins, Tresa; Diana McCaig; Ellen Subject: Re: [Histonet] Block Counts This discussion is exactly why we do not count blocks at microtomy, only slides. Counting slides is the equalizer for multiple levels and slides per block. Count the most appropriate unit at a task (i. e. slides at microtomy, blocks at embedding, specimens at grossing, specimens at accession inc) that allows you to set work pace and creates a corresponding quality measure. William DeSalvo william.desa...@sonoraquest.com 602-768-3692 Sent from my iPhone On Jan 12, 2015, at 4:05 PM, Morken, Timothy timothy.mor...@ucsf.edu wrote: I agree with Diana, I found we had over a dozen different task mixes in a given day for various techs. That includes mix of block types (bx, extensive lists of stain requests per block, single HE, recuts, mega block, research cases), other tasks (Staining, speicals, ihc, tissue processor . Grossing would be even more complicated. Instead of a per-day count, use per hour or per two hours - Some period when the person is concentrating on a single task without interruption. 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 Diana McCaig Sent: Monday, January 12, 2015 2:46 PM To: 'Goins, Tresa'; Ellen; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] Block Counts I have always found there are so many variables that having an expectation of setting a set number is not always possible. I feel they should be compared to their own standards and not of their co-workers. If they can cut or embed a set number on a particular than they should maintain or gradually increase (for newer techs) over time. . I have seen where in one day they cut so many blocks when the work load mandates it but on a slower day it takes them just as much time to cut half as many blocks. The work pace should be at their comfort level but should be a standard rate. Diana -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Goins, Tresa Sent: January-12-15 4:58 PM To: Ellen; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] Block Counts Depends on the type of tissue. Depends on the length of time your day is for a repetitive task. Assigning an arbitrary number is counterproductive. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Sent: Monday, January 12, 2015 1:57 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Block Counts I'm looking for raw data on time studies that directly deal with the number of blocks a PA can produce in a day and how many a histo tech can cut a day. Thanks Sent from my iPhone ___ 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 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet THIS MESSAGE IS CONFIDENTIAL. This e-mail message and any attachments are proprietary
[Histonet] FFPE Tissue as a bio-hazard
I am looking for documentation that talks about FFPE tissue as it relates to bio-hazards in the lab. When and where does tissue change from a bio-hazard to non bio-hazard.Needing to present to our safety department. They are ready to put us on lock down ;0/. Thanks for your help! Sent from my iPad ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Needed! Presenters for FSH 2015
Hi histonetters! The 2015 Florida Society Meeting will be held May 15-17 in Orlando. I know we have some great presenters out there who want to visit the beautiful city of Orlando! Maybe someone out there wants to get started with presenting? (Here's that nudge you've been waiting for...) What a great setting and group we have here in Florida to help accommodate the best of speakers-new and experienced. Interested? Submit your abstracts to me at mchilds2...@hotmail.com by Feb. 1. Come join us for sun, fun and learning! Looking forward to what you have to share with us here in Florida. Happy New Year to you all! Michelle Foster FSH Vice President Sent from my iPhone ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
Re: [Histonet] Block Counts
I feel the same way. I've been an Histo tech, AP manager, now a PA for the last 13 years and I can't get these people to understand. However I'm in a hospital system (4 hospitals) a lab director ( no pathology background) that is assigning works units to blocks as bill able units. We have 2 PA's, 7 Histo techs, 8 pathologist, 2 cyto techs. The director ( a pathologist) is trying to implement 200 blocks per PA. The problem is that 80% of our cases are complex, we average 2 whipples every other day, a truck load of mastectomies etc., Sent from my iPhone On Jan 13, 2015, at 5:07 AM, Podawiltz, Thomas tpodawi...@lrgh.org wrote: I have never really cared how fast or how many blocks can be embedded or cut per hour. I have always focused on the quality. In a hospital setting there is too much variety to have set numbers. Tom Podawiltz HT (ASCP) Histology Section Head LRGHealthcare Laconia, NH 03246 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of WILLIAM DESALVO Sent: Monday, January 12, 2015 6:18 PM To: Morken, Timothy Cc: histonet@lists.utsouthwestern.edu; Goins, Tresa; Diana McCaig; Ellen Subject: Re: [Histonet] Block Counts This discussion is exactly why we do not count blocks at microtomy, only slides. Counting slides is the equalizer for multiple levels and slides per block. Count the most appropriate unit at a task (i. e. slides at microtomy, blocks at embedding, specimens at grossing, specimens at accession inc) that allows you to set work pace and creates a corresponding quality measure. William DeSalvo william.desa...@sonoraquest.com 602-768-3692 Sent from my iPhone On Jan 12, 2015, at 4:05 PM, Morken, Timothy timothy.mor...@ucsf.edu wrote: I agree with Diana, I found we had over a dozen different task mixes in a given day for various techs. That includes mix of block types (bx, extensive lists of stain requests per block, single HE, recuts, mega block, research cases), other tasks (Staining, speicals, ihc, tissue processor . Grossing would be even more complicated. Instead of a per-day count, use per hour or per two hours - Some period when the person is concentrating on a single task without interruption. 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 Diana McCaig Sent: Monday, January 12, 2015 2:46 PM To: 'Goins, Tresa'; Ellen; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] Block Counts I have always found there are so many variables that having an expectation of setting a set number is not always possible. I feel they should be compared to their own standards and not of their co-workers. If they can cut or embed a set number on a particular than they should maintain or gradually increase (for newer techs) over time. . I have seen where in one day they cut so many blocks when the work load mandates it but on a slower day it takes them just as much time to cut half as many blocks. The work pace should be at their comfort level but should be a standard rate. Diana -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Goins, Tresa Sent: January-12-15 4:58 PM To: Ellen; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] Block Counts Depends on the type of tissue. Depends on the length of time your day is for a repetitive task. Assigning an arbitrary number is counterproductive. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Sent: Monday, January 12, 2015 1:57 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Block Counts I'm looking for raw data on time studies that directly deal with the number of blocks a PA can produce in a day and how many a histo tech can cut a day. Thanks Sent from my iPhone ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list
[Histonet] Cassette lableler and slide labeler
I didn't plan on this however wondered if anyone had a General Data system for making cassettes but a different setup for making slides, such as a Thermo Slidemate. I suspect there are issues with the LIS system, barcoding, etc.Am I wrong? Jim Jim Vickroy Histology Manager Springfield Clinic, Main Campus, East Building 1025 South 6th Street Springfield, Illinois 62703 Office: 217-528-7541, Ext. 15121 Email: jvick...@springfieldclinic.commailto:jvick...@springfieldclinic.com This electronic message contains information from Springfield Clinic, LLP that may be confidential, privileged, and/or sensitive. This information is intended for the use of the individual(s) or entity(ies) named above. If you are not the intended recipient, be aware that disclosure, copying, distribution, or action taken on the contents of this information is strictly prohibited. If you have received this electronic message in error, please notify the sender immediately, by electronic mail, so that arrangements may be made for the retrieval of this electronic message. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] FFPE Tissue as a bio-hazard
Tanya, in our institution we don't treat intact paraffin blocks as a biohazard, but we do collect all trimmings from the microtomes and put in red biohazard bags. The reasoning is that no one outside the lab knows what this stuff is so we err on the side of the safety, or perceived safety, of those downstream in waste cycle. 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 Tanya Ewing-Finchem Sent: Tuesday, January 13, 2015 5:46 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] FFPE Tissue as a bio-hazard I am looking for documentation that talks about FFPE tissue as it relates to bio-hazards in the lab. When and where does tissue change from a bio-hazard to non bio-hazard.Needing to present to our safety department. They are ready to put us on lock down ;0/. Thanks for your help! Sent from my iPad ___ 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] Cassette lableler and slide labeler
I am very interested in the answer to this questions, as we are in the process of trying to procure a General Data cassette printer, but I am not sure I will try for the slide printers. I would think you could map any instrument to your LIS, and barcode readers would read any 2-D barcode - the issue might be compiling data for stats? Thanks for asking this question. Michael Ann Jones, HT (ASCP) Histology Manager Metropath 7444 W. Alaska Dr. #250 Lakewood, CO 80226 303.634.2511 mjo...@metropath.com On 1/13/15, 8:44 AM, Vickroy, James jvick...@springfieldclinic.com wrote: I didn't plan on this however wondered if anyone had a General Data system for making cassettes but a different setup for making slides, such as a Thermo Slidemate. I suspect there are issues with the LIS system, barcoding, etc.Am I wrong? Jim Jim Vickroy Histology Manager Springfield Clinic, Main Campus, East Building 1025 South 6th Street Springfield, Illinois 62703 Office: 217-528-7541, Ext. 15121 Email: jvick...@springfieldclinic.commailto:jvick...@springfieldclinic.com This electronic message contains information from Springfield Clinic, LLP that may be confidential, privileged, and/or sensitive. This information is intended for the use of the individual(s) or entity(ies) named above. If you are not the intended recipient, be aware that disclosure, copying, distribution, or action taken on the contents of this information is strictly prohibited. If you have received this electronic message in error, please notify the sender immediately, by electronic mail, so that arrangements may be made for the retrieval of this electronic message. Thank you. ___ 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] Histotech position opening
Clinical Laboratory of the Black Hills is a growing, independent pathology practice providing anatomic and cytologic services to Rapid City, South Dakota and surrounding communities. Rapid City is the gateway to the Black Hills and offers a variety of four season, family friendly activities. Our histology department processes 25,000 surgical cases, and 200 autopsies per year. We also have a progressive IHC department, and perform a variety of special stains and frozen sections. HISTOTECH Immediate opening for a certified HT/HTL (ASCP) or equivalent. Duties include embedding, microtomy, chemical and reagent management and IHC procedures. Associate Degree in related field a plus. F/T – Day shifts only. Clinical Lab offers a competitive wage with an excellent benefit t package including health, vision and dental insurance, 401(k), Profit Sharing, and disability insurance. No state income tax. Relocation assistance is available. Send resume to: Janet Amundson, Human Resources Clinical Laboratory of the Black Hills 2805 5th Street, Suite 210 Rapid City, South Dakota 57701 Fax: 605-342-0418; Phone: 605-343-2267 Email: jamund...@clinlab.com ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] How are you applying this?
Hi All, Below is a copy of the revised COM.4 CAP checklist question. Now that Anatomic Pathology is having to comply with the All Common checklist, how are you applying this to your Immunohistochemistry ASR’s which are not FDA approved. We do new antibody validation and parallel testing with new lot numbers and clones. Is this enough? Can’t really see how the highlighted area pertains to this. Any advice would be appreciated. Thank. REVISED** 04/21/2014 COM.4 Method Validation/Verification Approval Phase II There is a summary statement, signed by the laboratory director (or designee who meets CAP director qualifications) prior to use in patient testing, documenting evaluation of validation/verification studies and approval of each test for clinical use. NOTE: This checklist item is applicable only to tests implemented after June 15, 2009. The summary statement must include a written assessment of the validation/verification study, including the acceptability of the data. The summary must also include a statement approving the test for clinical use with the approval signature such as, This validation study has been reviewed, and the performance of the method is considered acceptable for patient testing. For an FDA-cleared/approved test, a summary of the verification data must address analytic performance specifications, including analytic accuracy, precision, interferences, and reportable range, as applicable. In addition, for modified FDA-cleared/approved tests or LDTs, the summary must address analytical sensitivity, analytical specificity and any other parameter that is considered important to assure that the analytical performance of a test (e.g. specimen stability, reagent stability, linearity, carryover, and cross-contamination, etc.), as appropriate and applicable. If the laboratory makes clinical claims about its tests, the summary must address the validation of these claims. See the Method Performance Specifications section for details concerning validation/verification. Evidence of Compliance: ✓ Summary of validation/verification studies with review and approval REFERENCES 1) Lawrence Jennings, Vivianna M. Van Deerlin, Margaret L. Gulley (2009) Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests. Archives of Pathology Laboratory Medicine: Vol. 133, No. 5, pp. 743-755 Wanda Borowicz HT(ASCP) Histology Supervisor Sanford Health North 1720 S. University Dr. Route 1902 Fargo, ND 58103 Ph-701 417 4930 Fax-701 417 4399 wanda.borow...@sanfordhealth.orgmailto:wanda.borow...@sanfordhealth.org --- Confidentiality Notice: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain privileged and confidential information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: How are you applying this?
Yes, the ASR validation wording is easily applicable to clinical chemistry because they work with known amounts of an anylate but not exactly applicable to qualitative IHC without some explanation of the terms. I gave an NSH workshop addressing this and it is not easy to put in a quick email . Basically for ASR's you need to do a full validation of the antibody. You need to design the validation, document it, and then document that the antibody works as you expected. This takes some literature reading. By law a vendor cannot give you any information about how to do the test. That is all on the lab. The references below will give you what you need to know. The most recent recommendations: Principles of Analytic Validation of Immunohistochemical Assays: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center Patrick L. Fitzgibbons (Arch Pathol Lab Med. 2014;138:1432–1443) Available free online: http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2013-0610-CP An older one, but sill applicable: Recommendations for Improved Standardization of Immunohistochemistry, Goldstein, NS, et.al., and members of Ad-Hoc Committee on Immunohistochemical Standardization, Appl Immunohistochem Mol Morph, 2007 15(2): 124-133 Book: (excellent discussion of validation and relation of validation terms to IHC) Theoretical and Practical Aspects of Test Performance, in Immunohistology: A Diagnostic Tool for the Surgical Pathologist. 3rd. Ed., Volume 19 in Major Problems in Pathology, Taylor CR and Cote RJ, Eds., W.B Saunders, Philadelphia, 2005 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 Borowicz,Wanda Sent: Tuesday, January 13, 2015 1:03 PM To: 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] How are you applying this? Hi All, Below is a copy of the revised COM.4 CAP checklist question. Now that Anatomic Pathology is having to comply with the All Common checklist, how are you applying this to your Immunohistochemistry ASR’s which are not FDA approved. We do new antibody validation and parallel testing with new lot numbers and clones. Is this enough? Can’t really see how the highlighted area pertains to this. Any advice would be appreciated. Thank. REVISED** 04/21/2014 COM.4 Method Validation/Verification Approval Phase II There is a summary statement, signed by the laboratory director (or designee who meets CAP director qualifications) prior to use in patient testing, documenting evaluation of validation/verification studies and approval of each test for clinical use. NOTE: This checklist item is applicable only to tests implemented after June 15, 2009. The summary statement must include a written assessment of the validation/verification study, including the acceptability of the data. The summary must also include a statement approving the test for clinical use with the approval signature such as, This validation study has been reviewed, and the performance of the method is considered acceptable for patient testing. For an FDA-cleared/approved test, a summary of the verification data must address analytic performance specifications, including analytic accuracy, precision, interferences, and reportable range, as applicable. In addition, for modified FDA-cleared/approved tests or LDTs, the summary must address analytical sensitivity, analytical specificity and any other parameter that is considered important to assure that the analytical performance of a test (e.g. specimen stability, reagent stability, linearity, carryover, and cross-contamination, etc.), as appropriate and applicable. If the laboratory makes clinical claims about its tests, the summary must address the validation of these claims. See the Method Performance Specifications section for details concerning validation/verification. Evidence of Compliance: ✓ Summary of validation/verification studies with review and approval REFERENCES 1) Lawrence Jennings, Vivianna M. Van Deerlin, Margaret L. Gulley (2009) Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests. Archives of Pathology Laboratory Medicine: Vol. 133, No. 5, pp. 743-755 Wanda Borowicz HT(ASCP) Histology Supervisor Sanford
[Histonet] Vibratome services Worcester MA
Hello All, We have a client that needs vibratome services for mouse brains. We would like this to be in the area of Worcester MA but would settle for something within 50 miles. Can anyone recommend? Thank you Hans B Snyder Histologistics 60 Prescott Street Worcester, MA 01605 508-308-7800 h...@histologistics.com ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
