[Histonet] Fwd: [4]
Hey! http://labidiomasaiac.usb.ve/-hit.of.sales?quhuniq=7590994ivyvyzj=922180 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Slide Warmer
Can anyone recommend a good slide warmer? The more slides it can hold, the better. Thanks, Becky ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Validation of cryostat
Could anyone tell me how you are handling the new CAP ANP.23045 question on function and verification of equipment regarding a cryostat. Gloria Tharp, BA, HTL(ASCP) PCA Southeast Laboratory Director of Operations gth...@pcasoutheast.com 931-490-1005 931-619-5149 cell ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] (no subject)
How is everyone validating the tissue processor for new CAP ANP.23045 question on function and verification of equipment? LeAnn Murphy Aultman Hospital Canton, Ohio ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] (no subject)
What I did recently for two new processors, conventional type- I did parallel trial slides of multiple tissue types ( same types as patients) for fixation, morphology , processing artifacts for 9 programs. I grossed them in and recorded fixation times, type, thickness, overall dimensions. I ran on the test programs. Then I embedded and sectioned and evaluated the results by microscopic review by techs then the medical director of the H E stained sections for each program and tissue type. Looking at any autolysis, nuclear detail, poor dehydration, other processing problems in each set. Then I just made a simple evaluation sheet for any tissue processing related issues, with a number rating/scale for the results. Retained records of the validation runs and the stained sections used for validation. Defined acceptable tissue types and dimensions for the processing programs in the SOP, and then I just created back up/recovery procedure and reprocessing procedure and ran through those for comparison. When completed, I just compiled into validation summary report. Joelle Weaver MAOM, HTL (ASCP) QIHC From: lmurp...@aultman.com To: Histonet@lists.utsouthwestern.edu Date: Thu, 3 Apr 2014 15:26:17 + CC: Subject: [Histonet] (no subject) How is everyone validating the tissue processor for new CAP ANP.23045 question on function and verification of equipment? LeAnn Murphy Aultman Hospital Canton, Ohio ___ 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] proceesing of GI Bxs
Could someone please send me your processing schedule for GI bxs. We are using a Sakura VIP5 and are having problems with over drying and occasionally with infiltration of paraffin. Thanks ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: proceesing of GI Bxs
I'd appreciate a copy of that processing schedule for GI bxs as well. Thank you in advance Sincerely, Daniel Argüello, BS, CT (ASCP)CM Anatomic Pathology Services Coordinator Inspira Medical Center Woodbury 509 North Broad Street Woodbury, NJ 08096 856-853-2030 Ext 2808 856-853-2183 Fax arguel...@ihn.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vicki McKaughan Sent: Thursday, April 03, 2014 12:32 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] proceesing of GI Bxs Could someone please send me your processing schedule for GI bxs. We are using a Sakura VIP5 and are having problems with over drying and occasionally with infiltration of paraffin. Thanks ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: PA hours
We are a small lab, avg. 200/blocks/day. Our PA comes in at 0800, cleans up the gross room, cryostat, etc and usually starts with the placenta's from the previous night's deliveries. Also, she does all the frozen, and since our OR's start at 0730, we often have frozen by 0800 or soon after. I think it just all depends on the extra duties and when your Ors run. Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 -Original Message- Sent: Thursday, April 03, 2014 12:22 PM 1. PA hours (Carol Bryant) Message: 1 Date: Wed, 2 Apr 2014 17:01:15 -0400 From: Carol Bryant cb...@lexclin.com Subject: [Histonet] PA hours What hours are the PAs are grossing at your locations? The way our specimens arrive into the laboratory, we have someone from 12:30 -9:00 PM. Are any of your PAs working second or third shift hours? Thanks for any input. Regards, Carol ** - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Sausage blocks and tissue arrays
What is everyone doing for IHC control tissue? My path that made my sausage blocks is no longer here and reality has kicked in! I need to find a suitable replacement. Is anyone making their own control block or Sausage without using the microarray punch and paraffin block? Thanks, Cheri Cheryl A. Miller HT ASCP cm Histology Supervisor Hygiene Officer Physicians Laboratory, P.C. 4840 F St. Omaha , NE. 68117 402 731 4145 ext. 532 Cell 402 493 0403 Fax 402 731 8653 PRIVILEGED / CONFIDENTIAL INFORMATION may be contained in this message. If you are not the addressee intended / indicated or agent responsible for delivering it to the addressee, you are hereby notified that you are in possession of confidential and privileged information. Any dissemination, distribution, or copying of this e-mail is strictly prohibited. If you have received this message in error, please notify the sender immediately and delete this email from your system. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
Re: [Histonet] RE: proceesing of GI Bxs
We have a medium GI lab using the old, old VIP's. We have been very successful with two processing schedules, long and short. We found that we needed to add a bit of heat to the last xylene so when the tissue hit the first paraffin, they would start to infiltrate. The cold cassettes solidified the paraffin and the time spent was melting the paraffin not infiltrating the biopsy. For the longer run, we add 10%NBF and a bit longer in each solution. Short: 1. 70% reagent alcohol - 15 min, 40C, P/V 2. 85% reagent alcohol - 10 min, 40C, P/V 3. 85% reagent alcohol - 15 min, 40C, P/V 4. 100% reagent alcohol - 10 min, 40C, P/V 5. 100% reagent alcohol - 10 min, 40C, P/V 6. 100% reagent alcohol - 10 min, 40C, P/V 7. Xylene - 20 min, 40C, P/V 8. Xylene - 20 min, 50C, P/V 9. Paraffin - 10 min, 58C, P/V 10. Paraffin - 30 min, 58C, P/V 11. Paraffin - 45 min, 58C, P/V Karen Lahti, HT (ASCP), QIHC Arizona Digestive Health 602-687-7468 On Apr 3, 2014, at 9:33 AM, Arguello, Daniel arguel...@ihn.org wrote: I'd appreciate a copy of that processing schedule for GI bxs as well. Thank you in advance Sincerely, Daniel Argüello, BS, CT (ASCP)CM Anatomic Pathology Services Coordinator Inspira Medical Center Woodbury 509 North Broad Street Woodbury, NJ 08096 856-853-2030 Ext 2808 856-853-2183 Fax arguel...@ihn.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vicki McKaughan Sent: Thursday, April 03, 2014 12:32 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] proceesing of GI Bxs Could someone please send me your processing schedule for GI bxs. We are using a Sakura VIP5 and are having problems with over drying and occasionally with infiltration of paraffin. Thanks ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Instrument Verification
I just received my midcycle CAP and for cryostat validation, we are planning to cut and stain a piece of frozen tonsil and have the path sign off on it. For the tissue processors, we will run a one minute test program. I hope this will fly. Is it just me, or is CAP insanely out of control with new or modified regulations and policies for AP? Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 6. Validation of cryostat (Gloria Tharp) Message: 6 Date: Thu, 3 Apr 2014 09:59:26 -0500 From: Gloria Tharp gth...@pcasoutheast.com Could anyone tell me how you are handling the new CAP ANP.23045 question on function and verification of equipment regarding a cryostat. Gloria Tharp, BA, HTL(ASCP) -- Message: 7 Date: Thu, 3 Apr 2014 15:26:17 + From: Leann M. Murphy lmurp...@aultman.com How is everyone validating the tissue processor for new CAP ANP.23045 question on function and verification of equipment? LeAnn Murphy Aultman Hospital Canton, Ohio - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] RE: PA hours
PA's will work when the specimens are in the lab. As previously mentioned, if it's a hospital only lab, then a conventional day shift would work. After all, what surgeon wants to work past 4p? LOL!! However, if the lab services a hospital, surgery centers, doctor offices, etc., the PA or PA's will work when those specimens are available which usually means during the day, in the late afternoon and early evening. Mine is the later example. The specimens don't start arriving until 130p and keep coming until 630p. I have couriers dropping off specimens throughout the afternoon. I do supervisory work, coordinate the IT infrastructure, submit all of our primary malignant cases to our State Cancer Registry and in my spare time gross all of the specimens. I work from Noon to 830p or later. So, Carol...it all depends on the workload and when the work is received. Hope this helps!! Douglas A. Porter, HT (ASCP) Grossing Technician IT Coordinator Cancer Registrar CAP-Lab, PLC 2508 South Cedar Street Lansing, MI 48910-3138 517-372-5520 (phone) 517-372-5540 (fax) doug.por...@caplab.org www.caplab.org The information contained in this message may be privileged and/or confidential and protected from disclosure. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, copying, forwarding or capture of this communication is strictly prohibited. If you have received this communication in error, please notify me immediately by return e-mail and delete this and all copies. Thank-you. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Terri Braud Sent: Thursday, April 03, 2014 1:42 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: PA hours We are a small lab, avg. 200/blocks/day. Our PA comes in at 0800, cleans up the gross room, cryostat, etc and usually starts with the placenta's from the previous night's deliveries. Also, she does all the frozen, and since our OR's start at 0730, we often have frozen by 0800 or soon after. I think it just all depends on the extra duties and when your Ors run. Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 -Original Message- Sent: Thursday, April 03, 2014 12:22 PM 1. PA hours (Carol Bryant) Message: 1 Date: Wed, 2 Apr 2014 17:01:15 -0400 From: Carol Bryant cb...@lexclin.com Subject: [Histonet] PA hours What hours are the PAs are grossing at your locations? The way our specimens arrive into the laboratory, we have someone from 12:30 -9:00 PM. Are any of your PAs working second or third shift hours? Thanks for any input. Regards, Carol ** - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet - No virus found in this message. Checked by AVG - www.avg.com Version: 2014.0.4355 / Virus Database: 3722/7293 - Release Date: 04/03/14 ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Instrument Verification
I agree with you in that CAP is just looking for things to change and doesn't seem to be considering the change and decrease in staffing seen in clinical settings. Cryostat validation? Reallycut a slide after you have cleaned and pm'd the thing and go on. Good grief...I don't need any more paper and documentation on routine processes. As for tissue processors, I have 20 year old VIP's that have been running and producing specimens acceptably. I did validate them prior to being put in use but we didn't document like we do now. And I don't see the need to do it at this stage of use. We did do a very extensive validation on the Peloris we put into use last year and will going forward on new equipment. To me the daily QC of stain should provide our 'validation' of the process and include the processor. I am interested in others thoughts as well. Thanks for allowing me to rant. Cindi Robinson, HT(ASCP) Mercy Medical Center-Sioux City Dunes Medical Laboratories 350 W Anchor Drive Dakota Dunes SD 57049 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Terri Braud Sent: Thursday, April 03, 2014 1:00 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I just received my midcycle CAP and for cryostat validation, we are planning to cut and stain a piece of frozen tonsil and have the path sign off on it. For the tissue processors, we will run a one minute test program. I hope this will fly. Is it just me, or is CAP insanely out of control with new or modified regulations and policies for AP? Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 6. Validation of cryostat (Gloria Tharp) Message: 6 Date: Thu, 3 Apr 2014 09:59:26 -0500 From: Gloria Tharp gth...@pcasoutheast.com Could anyone tell me how you are handling the new CAP ANP.23045 question on function and verification of equipment regarding a cryostat. Gloria Tharp, BA, HTL(ASCP) -- Message: 7 Date: Thu, 3 Apr 2014 15:26:17 + From: Leann M. Murphy lmurp...@aultman.com How is everyone validating the tissue processor for new CAP ANP.23045 question on function and verification of equipment? LeAnn Murphy Aultman Hospital Canton, Ohio - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Instrument Verification
I'm with you. There really appears to be no value to this particular requirement.I would only be concerned with it if I had just purchased it, or moved it into our lab from another location. Martha Ward, MT (ASCP) QIHC Manager Molecular Diagnostics Lab Medical Center Boulevard \ Winston-Salem, NC 27157 p 336.716.2109 \ f 336.716.5890 mw...@wakehealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Cynthia Robinson Sent: Thursday, April 03, 2014 3:03 PM To: Terri Braud; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I agree with you in that CAP is just looking for things to change and doesn't seem to be considering the change and decrease in staffing seen in clinical settings. Cryostat validation? Reallycut a slide after you have cleaned and pm'd the thing and go on. Good grief...I don't need any more paper and documentation on routine processes. As for tissue processors, I have 20 year old VIP's that have been running and producing specimens acceptably. I did validate them prior to being put in use but we didn't document like we do now. And I don't see the need to do it at this stage of use. We did do a very extensive validation on the Peloris we put into use last year and will going forward on new equipment. To me the daily QC of stain should provide our 'validation' of the process and include the processor. I am interested in others thoughts as well. Thanks for allowing me to rant. Cindi Robinson, HT(ASCP) Mercy Medical Center-Sioux City Dunes Medical Laboratories 350 W Anchor Drive Dakota Dunes SD 57049 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Terri Braud Sent: Thursday, April 03, 2014 1:00 PM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I just received my midcycle CAP and for cryostat validation, we are planning to cut and stain a piece of frozen tonsil and have the path sign off on it. For the tissue processors, we will run a one minute test program. I hope this will fly. Is it just me, or is CAP insanely out of control with new or modified regulations and policies for AP? Terri L. Braud, HT(ASCP) Anatomic Pathology Supervisor Holy Redeemer Hospital Laboratory 1648 Huntingdon Pike Meadowbrook, PA 19046 Ph: 215-938-3676 Fax: 215-938-3874 6. Validation of cryostat (Gloria Tharp) Message: 6 Date: Thu, 3 Apr 2014 09:59:26 -0500 From: Gloria Tharp gth...@pcasoutheast.com Could anyone tell me how you are handling the new CAP ANP.23045 question on function and verification of equipment regarding a cryostat. Gloria Tharp, BA, HTL(ASCP) -- Message: 7 Date: Thu, 3 Apr 2014 15:26:17 + From: Leann M. Murphy lmurp...@aultman.com How is everyone validating the tissue processor for new CAP ANP.23045 question on function and verification of equipment? LeAnn Murphy Aultman Hospital Canton, Ohio - CONFIDENTIALITY NOTICE: This E-Mail is intended only for the use of the individual or entity to which it was sent. It may contain information that is privileged and/or confidential, and the use or disclosure of such information may also be restricted under applicable federal and state law. If you received this communication in error, please do not distribute any part of it or retain any copies, and delete the original E-Mail. Please notify the sender of any error by E-Mail. Thank you for your cooperation. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: 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 equipment validation is and that's why in my opinion its important. Histology laboratories are now responsible for running IHC that directly effects a patients treatment - meaning the numerous therapeutic and prognostic markers we routinely run now. Validation is an important process especially if you are using image analysis for these markers. I hate to say it but we better get used to it, because this is not going away. And now the shameless plug - I will be giving a 90 minute lecture at the Florida State Meeting https://classic.regonline.com/custImages/24/241449/FSH2014OnlineProgram.pdf on this exact topic, so if you want to learn how to create a Master Validation Plan and learn how to perform a basic validation or a more detailed IQ/OQ and PQ and to what extent you need to validate a particular piece of equipment - sign up for the meeting plus there are lots of other great topics being presented too. Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Premier Laboratory, LLC PO Box 18592 Boulder, CO 80308 (303) 682-3949 office (303) 682-9060 fax (303) 881-0763 cell l...@premierlab.com www.premierlab.com March 10, 2014 is Histotechnology Professionals Day Ship to Address: Premier Laboratory, LLC 1567 Skyway Drive, Unit E Longmont, CO 80504 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha Ward-Pathology Sent: Thursday, April 03, 2014 1:22 PM To: Cynthia Robinson; Terri Braud; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I'm with you. There really appears to be no value to this particular requirement.I would only be concerned with it if I had just purchased it, or moved it into our lab from another location. Martha Ward, MT (ASCP) QIHC Manager Molecular Diagnostics Lab Medical Center Boulevard \ Winston-Salem, NC 27157 p 336.716.2109 \ f 336.716.5890 mw...@wakehealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Cynthia Robinson Sent: Thursday, April 03, 2014 3:03 PM To: Terri Braud; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I agree with you in that CAP is just looking for things to change and doesn't seem to be considering the change and decrease in staffing seen in clinical settings. Cryostat validation? Reallycut a slide after you have cleaned and pm'd the thing and go on. Good grief...I don't need any more paper and documentation on routine processes. As for tissue processors, I have 20 year old VIP's that have been running and producing specimens acceptably. I did validate them prior to being put in use but we didn't document like we do now. And I don't see the need to do it at this stage of use. We did do a very extensive validation on the Peloris we put into use last year and will going forward on new equipment. To me the daily QC of stain should provide our 'validation' of the process and include the processor. I am interested in others thoughts as
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 equipment validation is and that's why in my opinion its important. Histology laboratories are now responsible for running IHC that directly effects a patients treatment - meaning the numerous therapeutic and prognostic markers we routinely run now. Validation is an important process especially if you are using image analysis for these markers. I hate to say it but we better get used to it, because this is not going away. And now the shameless plug - I will be giving a 90 minute lecture at the Florida State Meeting https://classic.regonline.com/custImages/24/241449/FSH2014OnlineProgram.pdf on this exact topic, so if you want to learn how to create a Master Validation Plan and learn how to perform a basic validation or a more detailed IQ/OQ and PQ and to what extent you need to validate a particular piece of equipment - sign up for the meeting plus there are lots of other great topics being presented too. Liz Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC Premier Laboratory, LLC PO Box 18592 Boulder, CO 80308 (303) 682-3949 office (303) 682-9060 fax (303) 881-0763 cell l...@premierlab.com www.premierlab.com March 10, 2014 is Histotechnology Professionals Day Ship to Address: Premier Laboratory, LLC 1567 Skyway Drive, Unit E Longmont, CO 80504 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha Ward-Pathology Sent: Thursday, April 03, 2014 1:22 PM To: Cynthia Robinson; Terri Braud; histonet@lists.utsouthwestern.edu Subject: [Histonet] RE: Instrument Verification I'm with you. There really appears to be no value to this particular requirement.I would only be concerned with it if I had just purchased it, or moved
