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/240000/241449/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? Really....cut 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 +0000 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? 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