[Histonet] New CAP question
One of the new CAP questions is ANP.22976 ER/PgR validation. If the laboratory performs immunohistochemistry for estrogen receptor and/or progesterone receptor as a prognostic/predictive marker on breast carcinoma, the laboratory has documented appropriate validation for the assays. In the note it says should include a minimum of 40 cases and validation should be performed by comparing the laboratory's results with another assay that has been appropriately validated. We have been doing ER/PR's for over ten years. Originally we compared our ER/PR testing with the old immunology method that used frozen breast tissue. We also compared our ER/PR results with another hospital. Problem is that this has been over ten years and we do not keep quality control records that long. Am I missing something? I know we use the FDA approved protocol from Ventana on our Ventana Benchmark XT. Should we do another validation study using Ventana or another hospital that is using the FDA approved method? Anybody understand what CAP is wanting and how to accomplish this? James Vickroy BS, HT(ASCP) Surgical and Autopsy Pathology Technical Supervisor Memorial Medical Center 217-788-4046 This message (including any attachments) contains confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this message. Any disclosure, copying, or distribution of this message, or the taking of any action based on it, is strictly prohibited. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] New CAP question ANP.22760
Thomas and Daniel both make good points. While clinical labs do run measurable (quantitative) tests they are also running completely closed systems in which all reagents are from a certain vendor. All the reagents are validated by a vendor and all reagents are validated and calibrated for that system. Running qualitative tests is only different at the interpretive stage. All other stages should be standardized and validated to ensure the system works as intended every day, every test. IHC, of course, is a whole different ballgame. There probably is not a single lab out there that uses only one vendor and uses only one system to do IHC testing. Even if you use one automated staining system you may use antibodies from a different vendor, or you may do something outside the system that is very different than other labs use. There is such disparity between testing in different labs that it is difficult to compare results and even techniques between labs. That is the crux of the issue and what CAP and others are trying to address by tightening the validation screws. In the near future labs will need to have very robust validation and documentation for all antibodies in order to prove they are doing things correctly. That scenario is already here for the breast markers. It will come for the others as well. Right now the instances in which solid validation methods are absolutely necessary is when validating the breast markers ER, PR and HER2, which all are used as stand-alone tests to determine treatment, and for ASR's. If you use a vendor kit with all reagents supplied you must still prove it works in your lab as intended (verify outside data. The outside data is the claim that it stains in a certain way). You must run cases of various expressions and show your lab gets the proper results. Third party verification is very helpful, that is, comparing your results to that of other labs on the same material (CAP surveys, or set up a partnership with another lab). If you use only the antibody for one of those markers, or mix and match components outside a FDA-approved kit, then you are responsible for performing a comprehensive validation of the test. Its worth noting that every news article I've seen about pathology/histology labs in the last several years has been about failures to do the breast panel tests correctly. We are under a microscope these days and it will pay off to make sure you are doing the tests well! Most other markers in IHC are ancillary tests that are run in conjunction with other tests to determine a diagnosis. Those antibodies still need to be validated in your system but don't require a large sample of cases. They have been validated as IVD's by the vendor so just need to be shown they work as intended with your lab's methods and instruments. But I still think it is worthwhile to do a validation that includes a range of expressions along with irrelevant tissue (negative). That will help calibrate your expectations about how the antibody works and give you a baseline to refer to if problems arise. Running one or two slides to make sure it works is not really satisfactory. Tim Morken Supervisor, Histology / IPOX UCSF Medical Center San Francisco, CA -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Thomas Jasper Sent: Saturday, June 26, 2010 1:45 PM To: Daniel Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Daniel, I think your observations are very good. Which brings me again to a point I was trying to make earlier. Anatomic Pathology is not the same as the General Clinical Lab or it's close counterparts. It almost seems like this is overblown re: validation. As you've pointed out, the interpretation is up to the pathologist. Patients (prostate, i.e.) will correlate with other tests. When known positives demonstrate properly you're valid. Even automated systems can use algorithms to score strength of positivity...which varies yet will show as positive (valid). You receive a new batch of Ab you run it on a known positive, that's the bottom line. It seems somehow CAP or clinical lab (trained) folks want more than that. And again (as you pointed out) the appreciation for the differences in how we operate as laboratorians seems to fall by the wayside. As you mention pushing 20, 50, 100 is not feasible (and frankly unnecessary). I don't know where the answer lies in making everyone happy here. I do know that some thinking outside the box and trying understand AP is required. We all want good patient care, but one size does not fit all. Thanks, tj -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Daniel Sent: Saturday, June 26, 2010 11:08 AM To: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question
RE: [Histonet] New CAP question ANP.22760
I have been reading the post to this question and it seems to me that there are different standards depending on the lab that is operating the methodology. I do agree that the core lab for years have had the instruction and training in the performance of validation. One thing that comes to mind as well is why has histology not had this training? Why are we not getting this from our certification agency, our professional societies and biggest reason where is our standardization. It seems to me that with all these regualtions in plac for so long, why were we missed. Is it because when inspected through CAP we are being inspected by a pathologist rather than a histo tech? These are some of the questions at hand. I to see new standards within the CAP checklist as well as other regulatory organizations that will affect the future of the Anatomic Pathology community. But I think we need is to provide a underlying architecture for our peers, so that we can begin the transition to the future. This is only the beginning, there is still Digital Image Analysis and Telepathology. It funny we are looking to become a hybrid of radiology and the core lab, but with the best of both worlds. Tim great structure for the validation study. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu on behalf of Morken, Tim Sent: Wed 6/23/2010 9:48 AM To: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Joe, You wrote : The folks in the 'clinical' lab have been performing more comprehensive and complex validation procedures for a very long time ... Those were my thoughts exactly. While the person replying may or may not have specific histology experience she will have clinical lab experience (however, my guess is that she is exposed to histology regularly at CAP). Clinical labs have a bit of an easier time, actually, because they validate primarily to known concentration controls - analytical controls manufactured at a range of known concentrations for instance. The institution then adds in their normal controls for validation. As far as the current question about validating a new lot of reagent the best practice is to run parallel tests on the same machine. If that is not easily possible on a particular manufacturer's instrument then the question should be asked of them: Why not? If this is a requirement the manufacturer should provide an easy path to meeting the requirement. However, if that is not the case then the institution simply writes a procedure to get around the inadequacies of the instrument (Maybe the vendor can help with that). Then follow the procedure. That should satisfy inspectors. An ...appropriate panel of tissues... is whatever the institution deems appropriate for the given antibody or reagent. This is a perfect place for tissue arrays. You can make your own or buy them. IHC must meet CLIA validation guidelines but since IHC is generally qualitative the requirements must be understood and methods adapted to a qualitative scenario. Several IHC and Histotechnology books discuss the subject at length (Taylor, Dabbs, Bancroft for instance). Below is a brief overview of how to do that. (for more in-depth info this was covered in an NSH teleconference I gave last year - PowerPoint, audio and references available from NSH-, and will be covered in a similar workshop at NSH in Seattle this year). 1) CAP General Validation CAP GEN.42020-42163 Test Method Validation Follows CLIA CFR Sec 493.1253 Does not apply well to IHC (IHC is usually qualitative) But the general principle applies: The laboratory must have data on each test's accuracy, precision, analytic sensitivity, interferences and reportable range. Unmodified FDA-cleared or approved tests: the lab may use manufacturer information or published reports but lab must verify outside data. Non-FDA cleared: Lab MUST verify or establish analytic accuracy, precision, sensitivity, specificity and reportable range. 2) Validation includes: Accuracy: Compare results with New antibody to a previously validated antibody on the same tissues Precision: Test samples with varying antigen expression Intra-run, Inter-run tests, 10 slides each (reproducibility) Sensitivity: True Positive vs False Negative (higher % FN = less sensitive) Interferences [Specificity]: True Negative vs False Positive (Higher % FP = less specific) Delineate what could interfere to give a false positive or false negative result. Reportable Range Establish a scoring system Provide the definition of a positive result 3)Sensitivity Analytic Sensitivity: Lowest amount of substance detectable by the test Can only be done with controls of known concentration Diagnostic Sensitivity: Ability of the test to determine true diagnostic positive verses false negative (higher % FN = less
RE: [Histonet] New CAP question ANP.22760
One question I think a lot of you are not considering is that the clinical laboratory usually tests for analytes present in most patients. This allows the clinical lab to more easily run validations with hundreds of patients, using statistical tools to analyze the precision, specificity and sensitivity of the test. What most of those concerned with this new CAP standard (and I count among them) is that our testing often targets a very rare population of patients. As such, an extensive validation is much more difficult to establish. It then makes the statistical models used in clinical tests much less valuble since the accuracy of these formulas decrease with smaller sample sizes. Additionally, the pathology of the clinical tests are reported as a measurement which does not have an intrinsic value. It must be interpreted by a clinician to give value to the patient. For example, the Blood Urea Nitrogen test value range usually is between 7-20 mg/dL while values above 50 are considered a marker of poor kidney function. Elevated values, however, do not mean that kidney functions are impaired but instead may be due to other pathologies such as congestive heart failure, gi bleeding, certain steroids and even diet. For histopathology even relatively common antibodies such as pan-T cell marker CD3 usually only stain 75% of T cell neoplasms. A negative result for that minority does not indicate that the tumor does not have a T cell lineage. It relies instead on the pathologist interpreting the result much as the clinician looks at the BUN value in relation to other factors in the patient's presentation. When we validate this kind of antibody, do we perform testing then on T cells and B cells (give me a good tonsil), on malignant samples or some combination of the two? What is a reasonable number of tests to run then? If I choose 10 normal lymphatic tissue blocks for my routine T/B cell marking (it can't be as extensive as ER/PR can it?) how many samples should I choose for my malignant population? If I use another 10 anyone with a background in statistics will tell you that the sample size is too small to interpret accuracy. If I push it up to 20, 50 or 100 I would be certain that many laboratories would not be able to afford the cost of the validation. This would then push many good laboratories out of the business of IHC with the unintended result of delaying diagnoses and increasing patient costs by driving testing to fewer and fewer testing outlets. CAP's new path with ER/PR seems to be trying to achieve a noble end of improving quality in the laboratory but without an understanding of the complexities and consequences of the method they are implementing. Dan -Original Message- From: Jesus Ellin jel...@yumaregional.org Sent: Jun 26, 2010 6:28 AM To: Morken, Tim timothy.mor...@ucsfmedctr.org, histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 I have been reading the post to this question and it seems to me that there are different standards depending on the lab that is operating the methodology. I do agree that the core lab for years have had the instruction and training in the performance of validation. One thing that comes to mind as well is why has histology not had this training? Why are we not getting this from our certification agency, our professional societies and biggest reason where is our standardization. It seems to me that with all these regualtions in plac for so long, why were we missed. Is it because when inspected through CAP we are being inspected by a pathologist rather than a histo tech? These are some of the questions at hand. I to see new standards within the CAP checklist as well as other regulatory organizations that will affect the future of the Anatomic Pathology community. But I think we need is to provide a underlying architecture for our peers, so that we can begin the transition to the future. This is only the beginning, there is still Digital Image Analysis and Telepathology. It funny we are looking to become a hybrid of radiology and the core lab, but with the best of both worlds. Tim great structure for the validation study. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu on behalf of Morken, Tim Sent: Wed 6/23/2010 9:48 AM To: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Joe, You wrote : The folks in the 'clinical' lab have been performing more comprehensive and complex validation procedures for a very long time ... Those were my thoughts exactly. While the person replying may or may not have specific histology experience she will have clinical lab experience (however, my guess is that she is exposed to histology regularly at CAP). Clinical labs have a bit of an easier time, actually, because they validate primarily to known concentration controls - analytical controls
RE: [Histonet] New CAP question ANP.22760
Daniel, I think your observations are very good. Which brings me again to a point I was trying to make earlier. Anatomic Pathology is not the same as the General Clinical Lab or it's close counterparts. It almost seems like this is overblown re: validation. As you've pointed out, the interpretation is up to the pathologist. Patients (prostate, i.e.) will correlate with other tests. When known positives demonstrate properly you're valid. Even automated systems can use algorithms to score strength of positivity...which varies yet will show as positive (valid). You receive a new batch of Ab you run it on a known positive, that's the bottom line. It seems somehow CAP or clinical lab (trained) folks want more than that. And again (as you pointed out) the appreciation for the differences in how we operate as laboratorians seems to fall by the wayside. As you mention pushing 20, 50, 100 is not feasible (and frankly unnecessary). I don't know where the answer lies in making everyone happy here. I do know that some thinking outside the box and trying understand AP is required. We all want good patient care, but one size does not fit all. Thanks, tj -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Daniel Sent: Saturday, June 26, 2010 11:08 AM To: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 One question I think a lot of you are not considering is that the clinical laboratory usually tests for analytes present in most patients. This allows the clinical lab to more easily run validations with hundreds of patients, using statistical tools to analyze the precision, specificity and sensitivity of the test. What most of those concerned with this new CAP standard (and I count among them) is that our testing often targets a very rare population of patients. As such, an extensive validation is much more difficult to establish. It then makes the statistical models used in clinical tests much less valuble since the accuracy of these formulas decrease with smaller sample sizes. Additionally, the pathology of the clinical tests are reported as a measurement which does not have an intrinsic value. It must be interpreted by a clinician to give value to the patient. For example, the Blood Urea Nitrogen test value range usually is between 7-20 mg/dL while values above 50 are considered a marker of poor kidney function. Elevated values, however, do not mean that kidney functions are impaired but instead may be due to other pathologies such as congestive heart failure, gi bleeding, certain steroids and even diet. For histopathology even relatively common antibodies such as pan-T cell marker CD3 usually only stain 75% of T cell neoplasms. A negative result for that minority does not indicate that the tumor does not have a T cell lineage. It relies instead on the pathologist interpreting the result much as the clinician looks at the BUN value in relation to other factors in the patient's presentation. When we validate this kind of antibody, do we perform testing then on T cells and B cells (give me a good tonsil), on malignant samples or some combination of the two? What is a reasonable number of tests to run then? If I choose 10 normal lymphatic tissue blocks for my routine T/B cell marking (it can't be as extensive as ER/PR can it?) how many samples should I choose for my malignant population? If I use another 10 anyone with a background in statistics will tell you that the sample size is too small to interpret accuracy. If I push it up to 20, 50 or 100 I would be certain that many laboratories would not be able to afford the cost of the validation. This would then push many good laboratories out of the business of IHC with the unintended result of delaying diagnoses and increasing patient costs by driving testing to fewer and fewer testing outlets. CAP's new path with ER/PR seems to be trying to achieve a noble end of improving quality in the laboratory but without an understanding of the complexities and consequences of the method they are implementing. Dan -Original Message- From: Jesus Ellin jel...@yumaregional.org Sent: Jun 26, 2010 6:28 AM To: Morken, Tim timothy.mor...@ucsfmedctr.org, histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 I have been reading the post to this question and it seems to me that there are different standards depending on the lab that is operating the methodology. I do agree that the core lab for years have had the instruction and training in the performance of validation. One thing that comes to mind as well is why has histology not had this training? Why are we not getting this from our certification agency, our professional societies and biggest reason where is our standardization. It seems to me that with all these regualtions in plac for so long, why were we missed. Is it because when
RE: [Histonet] New CAP question ANP.22760
Joe, You wrote : The folks in the 'clinical' lab have been performing more comprehensive and complex validation procedures for a very long time ... Those were my thoughts exactly. While the person replying may or may not have specific histology experience she will have clinical lab experience (however, my guess is that she is exposed to histology regularly at CAP). Clinical labs have a bit of an easier time, actually, because they validate primarily to known concentration controls - analytical controls manufactured at a range of known concentrations for instance. The institution then adds in their normal controls for validation. As far as the current question about validating a new lot of reagent the best practice is to run parallel tests on the same machine. If that is not easily possible on a particular manufacturer's instrument then the question should be asked of them: Why not? If this is a requirement the manufacturer should provide an easy path to meeting the requirement. However, if that is not the case then the institution simply writes a procedure to get around the inadequacies of the instrument (Maybe the vendor can help with that). Then follow the procedure. That should satisfy inspectors. An ...appropriate panel of tissues... is whatever the institution deems appropriate for the given antibody or reagent. This is a perfect place for tissue arrays. You can make your own or buy them. IHC must meet CLIA validation guidelines but since IHC is generally qualitative the requirements must be understood and methods adapted to a qualitative scenario. Several IHC and Histotechnology books discuss the subject at length (Taylor, Dabbs, Bancroft for instance). Below is a brief overview of how to do that. (for more in-depth info this was covered in an NSH teleconference I gave last year - PowerPoint, audio and references available from NSH-, and will be covered in a similar workshop at NSH in Seattle this year). 1) CAP General Validation CAP GEN.42020-42163 Test Method Validation Follows CLIA CFR Sec 493.1253 Does not apply well to IHC (IHC is usually qualitative) But the general principle applies: The laboratory must have data on each test's accuracy, precision, analytic sensitivity, interferences and reportable range. Unmodified FDA-cleared or approved tests: the lab may use manufacturer information or published reports but lab must verify outside data. Non-FDA cleared: Lab MUST verify or establish analytic accuracy, precision, sensitivity, specificity and reportable range. 2) Validation includes: Accuracy: Compare results with New antibody to a previously validated antibody on the same tissues Precision: Test samples with varying antigen expression Intra-run, Inter-run tests, 10 slides each (reproducibility) Sensitivity: True Positive vs False Negative (higher % FN = less sensitive) Interferences [Specificity]: True Negative vs False Positive (Higher % FP = less specific) Delineate what could interfere to give a false positive or false negative result. Reportable Range Establish a scoring system Provide the definition of a positive result 3)Sensitivity Analytic Sensitivity: Lowest amount of substance detectable by the test Can only be done with controls of known concentration Diagnostic Sensitivity: Ability of the test to determine true diagnostic positive verses false negative (higher % FN = less sensitive) Requires comparison to a previously validated antibody IHC Sensitivity: Extent to which an antibody can be diluted and still achieve target recognition. NOTE: This is determined by antibody AND detection system! 4) Specificity: Analytic Specificity Accuracy on tests of known positive and negative controls Controls of known concentration Determine what could Interfere to confound the result Diagnostic Specificity Ability of a test to determine true diagnostic negative verses false positives (Higher % FP = less specific) Requires comparison to a previously validated antibody IHC Specificity Ability of an antibody to bind exclusively to its particular antigen in the absence of staining of other molecules Or, staining of other structures in addition to target structures/cells (Sensitivity and Specificity adapted from: Theoretical and Practical Aspects of Test Performance, in Immunomicroscopy, Taylor Cote, 2005) Tim Morken Supervisor, Histology / IPOX UCSF Medical Center San Francisco, CA -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of jmye...@aol.com Sent: Tuesday, June 22, 2010 6:51 PM To: tjas...@copc.net Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Tom: As much as I agree with your acknowledgment that its seems
RE: [Histonet] New CAP question ANP.22760
Tom: As much as I agree with your acknowledgment that its seems a bit odd for the CAP to have a blood-banker responding to AP-related issue, I'm actually not surprised. The folks in the 'clinical' lab have been performing more comprehensive and complex validation procedures for a very long time, and they wonder why IHC isn't expected to follow the same requirements as chemistry, immunology, etc. -- IHC is, after all, an awful lot like ELISA. And rightfully so, because IHC is, under CLIA (which supersedes CAP), considered highly-complex, non-waived testing -- and is, therefore, subject to the same Quality Systems regulations (in particular, 42CFR493.1252-1256, 1273, and 1281) as the testing performed in other areas of the lab. Could it be that, because AP produces qualitative results that are interpreted by a pathologist and CP produces quantitative results that are interpreted by an analyzer, we somehow think that CLIA rules don't apply to IHC? I certainly don't have the answer to that, but it make me wonder what the future holds. As witnessed by some of the newest CAP 'standards' (including the question in question...no pun intended), e.g. ER/PR, where a minimum of 20 positive and 20 negative specimens must be tested, and where 10 of the positives must be weakly positive -- an acknowledgment that validation specimens must be carefully selected in order to obtain appropriate results), it certainly doesn't appear that the regulation of IHC testing is going to become more relaxed. Joe Myers, M.S., CT(ASCP) -- Message: 12 Date: Fri, 18 Jun 2010 12:38:07 -0700 From: Thomas Jasper tjas...@copc.net Subject: RE: [Histonet] New CAP question ANP.22760 To: Mark Tarango marktara...@gmail.com Cc: _histo...@lists.utsouthwestern.edu_ (mailto:histonet@lists.utsouthwestern.edu) Mark, Did you notice the credentials from this CAP representative? MT with a Blood Bank specialty I believe. What I glean from that is...more than likely this person does not grasp the logistics of contemporaneously staining identical Abs from separate lots. She also likely does not understand the logistical application for detection and automation either. I'm not trying to be overly critical of this person. I'm sure she is quite intelligent and would not have the MT/SBB if she wasn't intelligent. It comes down to a lack of understanding Anatomic Pathology testing application re: automated IHC. I believe this is a common problem in and out of CAP. Many lab directors and other folks in positions of authority without AP/Histology/Cytology backgrounds seem to believe that broad clinical lab modalities apply to Anatomic Path scenarios. I used to refer to this in my former position as - Trying to put the yoke of clinical lab onto anatomic path. We are laboratorians, but in many instances do not fit the general clinical lab mold. It's unfortunate that CAP has put this person in the position to respond. It is apparent to me that she's not grasping the particulars here. She probably never will unless she decides to go into a working, automated IHC tissue lab and take the time to ask questions and understand (learn) what we're all about. Thanks, Tom Jasper Thomas Jasper HT (ASCP) BAS Histology Supervisor Central Oregon Regional Pathology Services Bend, OR 97701 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] New CAP question ANP.22760
Should these slides be retained? If so, how long? Or is it enough just to have the documentation? -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu]on Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 8:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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 CONFIDENTIALITY NOTICE This message and any included attachments are from Somerset Medical Center and are intended only for the addressee. The information contained in this message is confidential and may contain privileged, confidential, proprietary and/or trade secret information entitled to protection and/or exemption from disclosure under applicable law. Unauthorized forwarding, printing, copying, distribution, or use of such information is strictly prohibited and may be unlawful. If you are not the addressee, please promptly delete this message and notify the sender of the delivery error by e-mail or you may call Somerset Medical Center's computer Help Desk at 908-685-2200, ext. 4050. Be sure to visit Somerset Medical Center's Web site - www.somersetmedicalcenter.com - for the most up-to-date news, event listings, health information and more. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] New CAP question ANP.22760
I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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] New CAP question ANP.22760
I do this but it has to be separate runs or wait until the kit is just running out. I also keep the slides from the initial QC run and compare it with the new lot to assure same intensity staining is obtained when changing lots. Cindi Robinson HT(ASCP) Mercy Medical Center Dunes Medical Laboratories 350 W Anchor Dr Dakota Dunes SD 57049 phone-712-279-2768 robin...@mercyhealth.com Mike Pence mpe...@grhs.net 6/18/2010 11:41 AM I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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] New CAP question ANP.22760
You'll have to use prep kit stickers and duplicate protocols to do it, but it is possible. You just need to copy the protocol and save it as another number, then change the primary antibody to a prep kit sticker save again and then put that sticker on the dispenser. Then you need to print stickers for both protocols and stick them on two controls slides and run. I admit its a little bit of a pain. Mark On Fri, Jun 18, 2010 at 9:41 AM, Mike Pence mpe...@grhs.net wrote: I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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] New CAP question ANP.22760
I think that CAP means that you need to save the slide that you ran from the previous lot and compare it to the slide that you have stained with the new lot number. To see if they are sufficient diagnostic quality. Not put both lot numbers on the machine at the same time and then compare the slides? We run Dako machines and it would be tricky to put both numbers on the same machine. Although this is my interpretation. Loralee McMahon, HTL (ASCP) Immunohistochemistry Supervisor Strong Memorial Hospital Department of Surgical Pathology (585) 275-7210 From: histonet-boun...@lists.utsouthwestern.edu [histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [mpe...@grhs.net] Sent: Friday, June 18, 2010 12:41 PM To: Ellen Yee; Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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] New CAP question ANP.22760
I'm kind of getting in on the middle of this but is anybody else doing this with prep kit stickers? I have not seen the new question but has anyone talked to CAP to get a clarification of what they mean on this question? James Vickroy BS, HT(ASCP) Surgical and Autopsy Pathology Technical Supervisor Memorial Medical Center 217-788-4046 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark Tarango Sent: Friday, June 18, 2010 12:27 PM To: Mike Pence Cc: histonet@lists.utsouthwestern.edu Subject: Re: [Histonet] New CAP question ANP.22760 You'll have to use prep kit stickers and duplicate protocols to do it, but it is possible. You just need to copy the protocol and save it as another number, then change the primary antibody to a prep kit sticker save again and then put that sticker on the dispenser. Then you need to print stickers for both protocols and stick them on two controls slides and run. I admit its a little bit of a pain. Mark On Fri, Jun 18, 2010 at 9:41 AM, Mike Pence mpe...@grhs.net wrote: I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21 PM To: Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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 (including any attachments) contains confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this message. Any disclosure, copying, or distribution of this message, or the taking of any action based on it, is strictly prohibited. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] New CAP question ANP.22760
Mark, Did you notice the credentials from this CAP representative? MT with a Blood Bank specialty I believe. What I glean from that is...more than likely this person does not grasp the logistics of contemporaneously staining identical Abs from separate lots. She also likely does not understand the logistical application for detection and automation either. I'm not trying to be overly critical of this person. I'm sure she is quite intelligent and would not have the MT/SBB if she wasn't intelligent. It comes down to a lack of understanding Anatomic Pathology testing application re: automated IHC. I believe this is a common problem in and out of CAP. Many lab directors and other folks in positions of authority without AP/Histology/Cytology backgrounds seem to believe that broad clinical lab modalities apply to Anatomic Path scenarios. I used to refer to this in my former position as - Trying to put the yoke of clinical lab onto anatomic path. We are laboratorians, but in many instances do not fit the general clinical lab mold. It's unfortunate that CAP has put this person in the position to respond. It is apparent to me that she's not grasping the particulars here. She probably never will unless she decides to go into a working, automated IHC tissue lab and take the time to ask questions and understand (learn) what we're all about. Thanks, Tom Jasper Thomas Jasper HT (ASCP) BAS Histology Supervisor Central Oregon Regional Pathology Services Bend, OR 97701 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark Tarango Sent: Friday, June 18, 2010 11:47 AM To: McMahon, Loralee A Cc: histonet@lists.utsouthwestern.edu Subject: Re: [Histonet] New CAP question ANP.22760 That's what I thought at first too. It might be helpful to post this letter that I got from the CAP about this. I tried to argue with them, but this is the answer I got. Dear Mark, Your questions were forwarded to me for response. During the Audio-conference, the idea of comparing a previously stained slide (that had used the old lot) to one stained with the new lot was deemed acceptable, but not optimal. Doing a simultaneous staining using old and new lots, better demonstrates the performance characteristics of the reagent. The reason parallel staining is considered best practice is that all other variables, such as variations in the lot of detection reagent or instrument function, are eliminated from consideration when the slides are stained contemporaneously. The antibody getting weak over time should not happen to a significant degree if the antibody is used within its expiration date. If the lab is having this kind of trouble, it should look carefully at its storage conditions. Demonstrating acceptable performance of the new lot, before being place into service, is *required* for all accredited laboratories. To answer the last question, the key is to order the new reagent well before you run out of the old lot so that the parallel stain can be performed before the old lot is consumed. One multi-tissue slide control slide would suffice to evaluate a primary antibody lot in most cases, which helps to minimize the impact on the lab. I hope that this information is helpful. Thank you for your participation in the Laboratory Accreditation Program. Sincerely, *Kathy Passarelli, MT(ASCP)SBB* *Technical Specialist* *Laboratory Accreditation Program* *College** of American** Pathologists* *Phone: 1-(800)-323-4040 ext 7486* *e-mail: **kpas...@cap.org* kpas...@cap.org On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A loralee_mcma...@urmc.rochester.edu wrote: I think that CAP means that you need to save the slide that you ran from the previous lot and compare it to the slide that you have stained with the new lot number. To see if they are sufficient diagnostic quality. Not put both lot numbers on the machine at the same time and then compare the slides? We run Dako machines and it would be tricky to put both numbers on the same machine. Although this is my interpretation. Loralee McMahon, HTL (ASCP) Immunohistochemistry Supervisor Strong Memorial Hospital Department of Surgical Pathology (585) 275-7210 From: histonet-boun...@lists.utsouthwestern.edu [ histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [ mpe...@grhs.net] Sent: Friday, June 18, 2010 12:41 PM To: Ellen Yee; Laurie Colbert Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] New CAP question ANP.22760 I don't think I can do this with the automated system we are currently using. Ventana. Does any other Ventana users know if you can do this in parallel Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Thursday, June 17, 2010 7:21
RE: [Histonet] New CAP question ANP.22760
Sorry, I should have included it. ANP.22760 Are new lots of antibody and detection system reagents tested in parallel with old lots? (NOTE: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues.) Ellen Yee _ From: Laurie Colbert [mailto:laurie.colb...@huntingtonhospital.com] To: Ellen Yee [mailto:e...@dpmginc.com] Sent: Thu, 17 Jun 2010 08:47:38 -0700 Subject: RE: [Histonet] New CAP question ANP.22760 Can you give us the wording of that question/checklist item? Laurie -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen Yee Sent: Wednesday, June 16, 2010 10:10 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question ANP.22760 How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ 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 CAP question ANP.22760
How are IHC labs complying with this question? What is considered an appropriate panel of control tissues? What do you stain to test your detection systems? Ellen Yee ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] New CAP question GEN.20425
We have addressed and answered this question by including the following statement on the bottom of our Period of Retention List : All the above mentioned will be sent to a facility (hospital) approved storage site in the event that the Clinical Laboratory or hospital closes. We had our CAP inspection earlier this year, and this statement was accepted by our inspector. Valerie Hannen, MLT (ASCP), HTL,SU (FL) Parrish Medical Center Titusville, Florida From: histonet-boun...@lists.utsouthwestern.edu on behalf of Shea's Sent: Thu 5/27/2010 6:26 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] New CAP question GEN.20425 How has your laboratory adressed the new CAP question GEN.20425 Has your laboratory or your institution developed a solution to the new CAP requirement below? GEN.20425 Does the laboratory have a policy to ensure that all records, slides, blocks, and tissues are retained and available for appropriate times should the laboratory cease operation? ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ** This email is intended solely for the use of the individual to whom it is addressed and may contain information that is privileged, confidential or otherwise exempt from disclosure under applicable law. If the reader of this email is not the intended recipient or the employee or agent responsible for delivering the 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 immediately delete this message. Thank you ** ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] New CAP question GEN.20425
How has your laboratory adressed the new CAP question GEN.20425 Has your laboratory or your institution developed a solution to the new CAP requirement below? GEN.20425 Does the laboratory have a policy to ensure that all records, slides, blocks, and tissues are retained and available for appropriate times should the laboratory cease operation? ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] New CAP question
ANP 22760: Are new lots of antibody and detection system reagents tested in parallel with old lots? Note: New lots of primary antibody and detection system reagents must be compared to the previous lot using an appropriate panel of control tissues. How is everyone out there handling this? What makes up a panel of control tissues? We are currently doing this by staining a control slide and comparing the results to the previous lot. Looking for guidance. Thank you for your help! Stacy ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] New CAP question on records and anatomic retention
Hello All: Just got our self inspection material and came across this new question dealing with ending lab operations. Has anyone, especially independent labs or hospitals not part of a big system, developed such a policy? Gen.20425 Does the laboratory have a policy to ensure that all records, slides, blocks and tissues are retained and available for appropriate times should the laboratory cease operations. Lester J. Raff, MD Medical Director UroPartners Laboratory 2225 Enterprise Dr. Suite 2511 Westchester, Il 60154 Tel 708.486.0076 Fax 708.486.0080 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
