Mark this is a new question and let me answer this for you from a inspection point of view. Currently there are 15 to 18 new questions that deal with predicative markers and the digital images, most of these are QA/QC related. But the issue with images is that your people are inspecting them. When you are looking at an image it is more than just click and go. There are technical issues of Tiling, focus with z stacking, AOI ( if the full image was captured), magnification, etc. This is just technical to images, but then there are the aspects that are to the histology world as in staining components, microtomy, fixation, etc. To say that they don't make a decision is a huge understatement. As far as I know CAP put this in because people were just scanning images and sending them off. There are also issues were the scanner scans for possible algorithm studies. You have to make sure this is inline. So as for the High complexity testing to what CLIA defines, that is a back and forth issue. Currently within our facility you have to be licensed HT/HTL to do scanning. This comes in line with the CAP looking at creating a QM program and having the technician/Technologist maintain competencies and assessments for this technology. There is also a competency and assessment due for the pathologist as well for this technology. I can go on and on, but you can contact me off line for this.
Jesus Ellin Yuma Regional Medical Center 928-336-1743 -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Mark Turner Sent: Wednesday, March 16, 2011 4:36 PM To: [email protected] Subject: [Histonet] CAP checklist, question ANP.23041. Regarding CAP checklist, question ANP.23041. "The operation of the imaging system is performed by high-complexity testing personnel." We have a question regarding the qualifications of the operators. The operators of the Aperio system are simply scanning entire slides to make a record for us prior to returning slides to the client. Our operators make no evaluation of the image other than whether the scan is adequate for recording purposes, and this is verified by our medical staff prior to release of the materials. In your opinion, does this constitute high-complexity testing and require CLIA compliant qualifications for the operators? Mark Turner, Ph.D, HT(ASCP) QIHC IHC / Histology Manager CSI Laboratories 770-817-0817 x 394 678-205-4669 FAX [email protected] <mailto:[email protected]> csilaboratories.com <https://csi-srv-007/exchweb/bin/redir.asp?URL=http://www.csi-labs.com/> 11525 Park Woods Circle Alpharetta, GA 30005 Important Warning: This e-mail is intended for the use of the person to whom it is addressed and may contain information that is privileged and confidential, the disclosure of which is governed by applicable law. If the reader of this e-mail is not the intended recipient, or the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this information is STRICTLY PROHIBITED. If you have received this message in error, please notify us immediately and delete the related e-mail. _______________________________________________ Histonet mailing list [email protected] http://lists.utsouthwestern.edu/mailman/listinfo/histonet ______________________________________________________________________ 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. If you receive this message in error, or are not the named recipient(s), please notify the sender at either the e-mail, fax, address, or telephone number listed above and delete this e-mail from your computer. Thank You. ______________________________________________________________________ _______________________________________________ Histonet mailing list [email protected] http://lists.utsouthwestern.edu/mailman/listinfo/histonet
