I am going to attach the information where you can find what is high complexity testing as defined by CLIA,, also CAP defines the QA/QC of this process to be the high complexity ,, also the antibody workup,, here is the website where you can get this information from. Again if you look at the CAP regs its states there the QA/QC as high complexity,, We can cut pull controls, place on machine and run,, but we can not Qa/QC reaction,, weird huh.
On another note the inspector stated that the grandfather clause is good for those testing methologies and test that were pre 1997,, so if still doing same testing after 1997 then good to go,, if test have changed for instance predictive markers, testing kits that are defined by the link I sent you ,, then they are not eligible unless they meet those requirments. Your thoughts Jesus Ellin http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm -----Original Message----- From: Morken, Timothy [mailto:timothy.mor...@ucsf.edu] Sent: Tuesday, November 22, 2016 11:17 AM To: Jesus Ellin Cc: Histonet Subject: RE: Personel Jesus, that is very interesting information. Does anyone know of any CAP accreditation documents that state explicitly that IHC slide staining is high complexity? I have not seen any. If anyone has those documents I'd like to see them. The only reference from CAP about that classification I have seen was in a Q&A session transcript from a CAP webinar on competency testing. The webinar had no information about IHC and complexity. However, a presenter answering a question about whether IHC staining at the bench is a high complexity "test," did state that IHC staining is high complexity so the techs doing the staining must have competency testing. Very strange! That's not to say I don't think IHC is high complexity - I do, and so is every other test in histology. But under CLIA the testing personnel is the pathologist, not the bench tech. CAP can deem IHC bench testing as high complexity if it wishes (CLIA is a baseline and deemed accrediting agencies, and institutions, can have stricter requirements). But it seems the only way anyone can find out if CAP classifies IHC as high complexity is to call them and ask. Your comment about new technology is interesting. In a modern scenario, which tech is the person who is "staining" the slide? And which of these is the "high complexity" part of the process? 1) person collating slides to stain 2) Person who programs the stainer 3) Person who dilutes the antibodies (still done!) 4) person who loads reagents on the stainer 5) person who loads the slides on the stainer 6) person who starts the stainer 7) person who unloads the slides from the stainer 8) person who labels and distributes the slides. 9) Person who checks QC slides (BTW, not a "test,"). In our lab these tasks are traded off by many different people throughout the day How about the person doing the validation of the stain? They are not doing a "test" but they are making the test possible to do. Just some questions to ponder over the holidays! Tim Morken Pathology Site Manager, Parnassus Supervisor, Electron Microscopy/Neuromuscular Special Studies Department of Pathology UC San Francisco Medical Center -----Original Message----- From: Jesus Ellin via Histonet [mailto:histonet@lists.utsouthwestern.edu] Sent: Tuesday, November 22, 2016 9:36 AM To: histonet@lists.utsouthwestern.edu Subject: [Histonet] Personel So I know I am going to open Pandoras box,, but have people been paying attention to the Personal requirements from CAP. I called the CAP and asked them about the criteria concerning Moderate or High complexity testing, after discussing with them the situations, IF you have a tech that is Licensed and Also has a QIHC, but does not minimum requirement Defined by CLIA in education ,, they CAN NOT do any QA/OC of IHC and antibody work up,, as IHC is defined as High complexity testing. I also asked about the test systems. The grandfather clause is only good for test systems that occurred for those time periods. For instance if CLIA defined the test system after those dates of 1997,, then they are not included and the person cannot perform test and technology created after those dates, since the testing was not in place during the grandfather clause time. In a nut shell meaning if the IHC staining and antibody was developed after those dates,, you are not covered by the grandfather clause to do the testing ,, can some help clear this up,, So any help on this matter will do ______________________________________________________________________ This message is confidential, intended only for the named recipient(s) and may contain information that is privileged or exempt from disclosure under applicable law. If you are not the intended recipient(s), you are notified that the dissemination, distribution, or copying of this message is strictly prohibited. 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