[Histonet] RE: Instrument Verification

Thu Apr 3 15:16:58 CDT 2014

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
liz <@t> 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-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Martha Ward-Pathology
Sent: Thursday, April 03, 2014 1:22 PM
To: Cynthia Robinson; Terri Braud; histonet <@t> 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 mward <@t> wakehealth.edu  

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Cynthia Robinson
Sent: Thursday, April 03, 2014 3:03 PM
To: Terri Braud; histonet <@t> 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-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Terri Braud
Sent: Thursday, April 03, 2014 1:00 PM
To: histonet <@t> 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" <gtharp <@t> 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" <LMurphy2 <@t> 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 <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet