RE: [Histonet] RE: Instrument Verification
I must say, the first time I read ANP.23045 I had the same reaction you all did. After reading it over a couple of times, we started looking at it differently. The question is not about validation--- it is about verifying that the equipment will function and perform as intended. It doesn't have anything to do with protocols and procedures for staining, cutting, processing, etc. If you look at any service report for service performed on your instrument, it is likely that the service engineer has some sort of notation on the report that states the unit was run and monitored for performance and meets all specs. To comply with the CAP question we merely wrote a procedure for Instrument-Equipment Performance Verification stating that 1)The verification of instrument/equipment function will be performed by a qualified service engineer upon installation, after scheduled preventative maintenance, major instrument repairs, or relocation. 2) Use of the instrument/equipment will resume after the verification of its performance has been successfully completed.3) The service engineer will provide the Histology Laboratory with a report indicating that performance function was tested and satisfactory. Of course, we also have all service reports (which include the notation that the function checks were performed and acceptable) available for each instrument. Suzie Miller, MLT ASCP Senior Histotech Mercy Health System of Maine Laboratory -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of joelle weaver Sent: Thursday, April 03, 2014 7:52 PM To: Elizabeth Chlipala; Martha Ward-Pathology; Cynthia Robinson; Terri Braud; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] RE: Instrument Verification I do understand and sympathize with the situation in many clinical labs with staff , sometimes barely enough to do the work and it is challenging to keep up with expanding documentation also. I would like to meet the GLP, but do struggle to be as extensive in my documentation. I do try to get as close to the ISO standards as possible, just to cover myself. I agree with Elizabeth's post that this seems to be the direction CAP has been heading over the years. I think that if you get new instruments, methodology, technology they will certainly want to see the more robust documentation. For example ( see the current CAP today on IHC validation), this will surely be the guideline of tomorrow But for those older, in long use instruments and technology, my opinion is that if you have documentation in line with what the checklist stipulated when it went into use, and also all PM, maintenance, and QC- and have documented any corrective actions, this will probably fly for now? What does everyone else think? Joelle Weaver MAOM, HTL (ASCP) QIHC From: l...@premierlab.com To: mw...@wakehealth.edu; robin...@mercyhealth.com; tbr...@holyredeemer.com; histonet@lists.utsouthwestern.edu Date: Thu, 3 Apr 2014 14:16:58 -0600 CC: Subject: [Histonet] RE: Instrument Verification Hello All Coming from a GLP environment this type of equipment validation is standard in our setting. This is just my opinion but I think the CAP checklist is moving towards the type of equipment documentation that is already required in a GxP or ISO environment. I always thought that instrument qualification (IQ) - operational qualification (OQ) and process qualification (PQ) or simply stated IQ/OQ/PQ were used only in GxP settings but you now see some of the larger clinical labs running these types of validations on their equipment and processes. To me it does make sense that some type of equipment validation should be required whether it is a two page document on the microtomes, waterbaths, etc. or complete IQ/OQ/PQ's on major pieces of equipment such as tissue processors, immunostainers and IHC retrieval units. I believe that all of these are important processes that should be completed in histology laboratories today.We are a GLP compliant lab and every single piece of equipment is calibrated and validated as designated in our Master Validation Plan. IHC stainers and retrieval units should be validated, even our refrigerators and freezers are calibrated and validated. Our pipettors are calibrated quarterly, and any piece of equipment that generates a weight or temperature is calibrated yearly. For example if you do not validate your IHC retrieval units how can you really tell if they reach the temperature that they are programmed to reach, does the temperature stay consistent through the retrieval process, did it retrieve for the time programmed? The only way to determine this is to perform a validation. How do you troubleshoot problems if you do not know if your instruments are performing to their specification without testing those specifications - that's what
RE: [Histonet] RE: Instrument Verification
Pretty much what is in place here for existing/established instruments. Joelle Weaver MAOM, HTL (ASCP) QIHC From: mill...@emhs.org To: joellewea...@hotmail.com; l...@premierlab.com; mw...@wakehealth.edu; robin...@mercyhealth.com; tbr...@holyredeemer.com; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] RE: Instrument Verification Date: Fri, 4 Apr 2014 10:08:54 + I must say, the first time I read ANP.23045 I had the same reaction you all did. After reading it over a couple of times, we started looking at it differently. The question is not about validation--- it is about verifying that the equipment will function and perform as intended. It doesn't have anything to do with protocols and procedures for staining, cutting, processing, etc. If you look at any service report for service performed on your instrument, it is likely that the service engineer has some sort of notation on the report that states the unit was run and monitored for performance and meets all specs. To comply with the CAP question we merely wrote a procedure for Instrument-Equipment Performance Verification stating that 1)The verification of instrument/equipment function will be performed by a qualified service engineer upon installation, after scheduled preventative maintenance, major instrument repairs, or relocation. 2) Use of the instrument/equipment will resume after the verification of its performance has been successfully completed.3) The service engineer will provide the Histology Laboratory with a report indicating that performance function was tested and satisfactory. Of course, we also have all service reports (which include the notation that the function checks were performed and acceptable) available for each instrument. Suzie Miller, MLT ASCP Senior Histotech Mercy Health System of Maine Laboratory -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of joelle weaver Sent: Thursday, April 03, 2014 7:52 PM To: Elizabeth Chlipala; Martha Ward-Pathology; Cynthia Robinson; Terri Braud; histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] RE: Instrument Verification I do understand and sympathize with the situation in many clinical labs with staff , sometimes barely enough to do the work and it is challenging to keep up with expanding documentation also. I would like to meet the GLP, but do struggle to be as extensive in my documentation. I do try to get as close to the ISO standards as possible, just to cover myself. I agree with Elizabeth's post that this seems to be the direction CAP has been heading over the years. I think that if you get new instruments, methodology, technology they will certainly want to see the more robust documentation. For example ( see the current CAP today on IHC validation), this will surely be the guideline of tomorrow But for those older, in long use instruments and technology, my opinion is that if you have documentation in line with what the checklist stipulated when it went into use, and also all PM, maintenance, and QC- and have documented any corrective actions, this will probably fly for now? What does everyone else think? Joelle Weaver MAOM, HTL (ASCP) QIHC From: l...@premierlab.com To: mw...@wakehealth.edu; robin...@mercyhealth.com; tbr...@holyredeemer.com; histonet@lists.utsouthwestern.edu Date: Thu, 3 Apr 2014 14:16:58 -0600 CC: Subject: [Histonet] RE: Instrument Verification Hello All Coming from a GLP environment this type of equipment validation is standard in our setting. This is just my opinion but I think the CAP checklist is moving towards the type of equipment documentation that is already required in a GxP or ISO environment. I always thought that instrument qualification (IQ) - operational qualification (OQ) and process qualification (PQ) or simply stated IQ/OQ/PQ were used only in GxP settings but you now see some of the larger clinical labs running these types of validations on their equipment and processes. To me it does make sense that some type of equipment validation should be required whether it is a two page document on the microtomes, waterbaths, etc. or complete IQ/OQ/PQ's on major pieces of equipment such as tissue processors, immunostainers and IHC retrieval units. I believe that all of these are important processes that should be completed in histology laboratories today.We are a GLP compliant lab and every single piece of equipment is calibrated and validated as designated in our Master Validation Plan. IHC stainers and retrieval units should be validated, even our refrigerators and freezers are calibrated and validated. Our pipettors are calibrated quarterly, and any piece of equipment that generates a weight or temperature is calibrated yearly. For example if
[Histonet] GI Biopsies
Does anyone have problems with their GI biopsies kind of shredding when cutting? I microwave process them in the Shurwave microwave processor. I have been doing this for over a year and only the past couple months I have noticed that almost every biopsy I cut has knife lines in it. I have to change my blade constantly. I was told by a TBS technician that if I ever noticed the tissue doing this, it meant that I did not have all the alcohol out of the tissue, but does that sound like it would cause the tissue to shred like that? I don't use my reagents more than 2 times and I have even tried increasing the time and temp a little but no help. I have been doing them for a year and did not have a problem and I haven't changed anything. Any solutions or suggestions??? Thanks! Tasha Campbell, B.S.,HTL(ASCP) Frederick Gastroenterology Associates 310 W. 9th St. Frederick, MD 21701 301-695-6800 ext. 144 (w) 304-685-9307 (c) ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] PFK's on muscle biopsies
Happy Friday !! For years now our PFK staining has been inconsistent and I'm hoping someone wouldn't mind sharing their no fail PFK method so I can make my neuropath's happy again.?? Julia Celebre Sr MLT Anatomic Pathology Hamilton Civic Hospitals 905-527-4322 ext 46179 This information is directed in confidence solely to the person named above and may not otherwise be distributed, copied or disclosed. Therefore, this information should be considered strictly confidential. If you have received this email in error, please notify the sender immediately via a return email for further direction. Thank you for your assistance. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] anti-FLAG antibody
Happy Friday! I am looking for a source of anti-FLAG antibody that works in mouse FFPE tissues. Bonus points if it work with Ventana/Roche instrumentation. Teri Johnson Manager, Histology Genomics Institute for Novartis Research Foundation San Diego, CA 858-332-4752 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] 45th Annual Illinois Society for Histotechnologists Meeting May 15 16
Hello, It is time to register for the 45th Annual ISH SPring Symposium in Bloomington, IL May 15 16, 2014. Please see the following website for complete meeting details and to register online. http://www.illinoishistologysociety.org/meetings.html THank you! -- Lori Ann Bellafiore *Pathology Education Specialist* *Genentech* 217.508.9975 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Ventana and CoPath Inface (HL7 Stain Order Interface)
We currently use the ABT system of CoPath Plus and have three Ventana Ultra Stainers and two Benchmark Special Stainers. We have been told that the HL7 Stain Order Interface will save us a lot of clerical time. We are trying to contact someone that already has this interface to see if it is worth the money. Please let us know if you have the interface and your experience with it. If possible maybe we could contact you and get some feedback. Jim V 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
[Histonet] Biocare intellipath
I'm looking for some honest feedback from anyone using the Biocare Intellipath in a clinical setting. Pros, cons, etc. Thanks, Deloris Carter, HT(ASCP) dels...@gmail.com ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
