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 +0000 > > 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 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? > > 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. 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