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: [email protected] [mailto:[email protected]] On Behalf Of joelle weaver Sent: Thursday, April 03, 2014 7:52 PM To: Elizabeth Chlipala; Martha Ward-Pathology; Cynthia Robinson; Terri Braud; [email protected] 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: [email protected] > To: [email protected]; [email protected]; > [email protected]; [email protected] > 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 > [email protected] > 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: [email protected] > [mailto:[email protected]] On Behalf Of Martha > Ward-Pathology > Sent: Thursday, April 03, 2014 1:22 PM > To: Cynthia Robinson; Terri Braud; [email protected] > 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 [email protected] > > > > > > -----Original Message----- > From: [email protected] > [mailto:[email protected]] On Behalf Of > Cynthia Robinson > Sent: Thursday, April 03, 2014 3:03 PM > To: Terri Braud; [email protected] > 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: [email protected] > [mailto:[email protected]] On Behalf Of Terri > Braud > Sent: Thursday, April 03, 2014 1:00 PM > To: [email protected] > 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" <[email protected]> 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" <[email protected]> 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. 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