Are We Insane?

Insanity: doing the same thing over and over again and expecting different results. In this issue of the Journal, a distinguished group of cytotechnologists and pathologists have collaborated, in my opinion, to bravely report that Papanicolaou (Pap) screening at high slide volumes negatively affects screening performance.1 Are we at all surprised? This study focuses on experiments that used a state-of-the-art location-guided screening system, and similar data have also been reported by one of the senior authors using the other major competing system.2 Both systems were approved by the US Food and Drug Administration (FDA) based on clinical trials that demonstrated similar or modestly improved accuracy compared with manual screening. Yet based on mathematical considerations of slide area, slide cellularity, etc, such systems also include, as part of their FDA labeling, the potential to have per-individual-slide throughput limits substantially higher than the 100-slide-per-day ceiling set by the Clinical Laboratory Improvement Amendments (CLIA). Both of these studies and many of their cited references demonstrated that the real-world performance of technologists who screen at anywhere near the workload limits has decreased sensitivity and accuracy by a variety of measures. As medical professionals, are technologists and pathologists actually comfortable working day in day out at the limits of personal productivity? How does one reconcile that comfort zone with our mandates to do no harm and always put patients first? Rather than going into the details of the important study by Levi and coworkers,1 I would like to take this opportunity to make some admittedly anecdotal and personal comments related to the inherent tensions and conflicts that exist even today between professional responsibility and perceptions or mandates of productivity. Parenthetically I note that once again the paradigm of cervical cancer screening is an excellent lens for reflecting on more general tensions in our current health care system.