Ok I get you don't need to read about about because you live it.
What are you doing about it then? Anything?
Is your lab reporting it to Cytyc and the FDA? Are you reporting to anyone if they don't?
My point is why roll over and play dead and say there is nothing you can do about it???Quitter. Why don't you bring attention to these cases instead of just saying "scary".
I don't mean to be a hard ass but COME ON...THESE CASES CAN CHANGE WHAT WE BITCH ABOUT DAY IN AND DAY OUT!!! How can I express it any any other way?
I am not mad at you. Point well taken. We did report the cases to Cytyc. We were told to show them to the field rep. and that she would review the cases and if warranted, these cases would help to further improve the technology. After keeping notes on these missed imaged cases, presenting them to the pathologists and to QA, nothing happened. I gave up. I used what I learned over the years to improve my personal accuracy in reading imaged slides by learning what types of cells are likely to be missed..like plaques of low grade. It has difficulty at times finding it. I think this is because it has a priority of searching out single high grade cells, and in the process misses the other cells.
I did share that information with the CAC when they were asking for feed back on the Imager in order to help craft/amend the legislation before the law that Cytyc sponsored
sunset. The initial legislation called for a period to study the Imager and any research papers were to be reviewed during this period. The amendment called for the workload limits fo each cytotech to be determined by the technical supervisor where before it was set by the manufacturer.
As far as I know, we never reported this to the FDA. However, I do know of a Cytotech who did report to this information to Karen Nichol, Chief of Laboratory Field Services. Nichol, at first seemed interested in what she had to say, but later in the conversation, she became short and annoyed with what she had to say. To make a long story short, Nichol told her that if a cytotech was overworked and tired, that was not her concern and that there was no proof that the imager was any less accurate than the cytotech.
We just figured that they were all in the pocket of Hologic and we were helpless against this corporation, especially when our own professional organizations were quiet on the issue, stating that they did not have an opinion. How many times have I gone to a CAC meeting in the past where Cytyc and SurePath were sponsors? Nearly all of the former CAC officers either worked or work for Hologic.
Everyone that I have talked to about this has had a similar experience. It is not that we don't care. We are tired. By the way, did Cytyc have you sign the same non disclosure agreement that were had to sign at our lab. In the agreement, we were not to share any information about the Imager with any other lab.