Tom: As much as I agree with your acknowledgment that its seems a bit odd for the CAP to have a blood-banker responding to AP-related issue, I'm actually not surprised. The folks in the 'clinical' lab have been performing more comprehensive and complex validation procedures for a very long time, and they wonder why IHC isn't expected to follow the same requirements as chemistry, immunology, etc. -- IHC is, after all, an awful lot like ELISA. And rightfully so, because IHC is, under CLIA (which supersedes CAP), considered highly-complex, non-waived testing -- and is, therefore, subject to the same Quality Systems regulations (in particular, 42CFR493.1252-1256, 1273, and 1281) as the testing performed in other areas of the lab. Could it be that, because AP produces qualitative results that are interpreted by a pathologist and CP produces quantitative results that are interpreted by an analyzer, we somehow think that CLIA rules don't apply to IHC? I certainly don't have the answer to that, but it make me wonder what the future holds. As witnessed by some of the newest CAP 'standards' (including the question in question...no pun intended), e.g. ER/PR, where a minimum of 20 positive and 20 negative specimens must be tested, and where 10 of the positives must be weakly positive -- an acknowledgment that validation specimens must be carefully selected in order to obtain appropriate results), it certainly doesn't appear that the regulation of IHC testing is going to become more relaxed. Joe Myers, M.S., CT(ASCP) ------------------------------
Message: 12 Date: Fri, 18 Jun 2010 12:38:07 -0700 From: "Thomas Jasper" <tjas...@copc.net> Subject: RE: [Histonet] New CAP question ANP.22760 To: "Mark Tarango" <marktara...@gmail.com> Cc: _histo...@lists.utsouthwestern.edu_ (mailto:histonet@lists.utsouthwestern.edu) Mark, Did you notice the credentials from this CAP representative? MT with a Blood Bank specialty I believe. What I glean from that is...more than likely this person does not grasp the logistics of "contemporaneously" staining identical Abs from separate lots. She also likely does not understand the logistical application for detection and automation either. I'm not trying to be overly critical of this person. I'm sure she is quite intelligent and would not have the MT/SBB if she wasn't intelligent. It comes down to a lack of understanding Anatomic Pathology testing application re: automated IHC. I believe this is a common problem in and out of CAP. Many lab directors and other folks in positions of authority without AP/Histology/Cytology backgrounds seem to believe that broad clinical lab modalities apply to Anatomic Path scenarios. I used to refer to this in my former position as - "Trying to put the yoke of clinical lab onto anatomic path." We are laboratorians, but in many instances do not fit the general clinical lab mold. It's unfortunate that CAP has put this person in the position to respond. It is apparent to me that she's not grasping the particulars here. She probably never will unless she decides to go into a working, automated IHC "tissue" lab and take the time to ask questions and understand (learn) what we're all about. Thanks, Tom Jasper Thomas Jasper HT (ASCP) BAS Histology Supervisor Central Oregon Regional Pathology Services Bend, OR 97701 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet