In the wake of the FDA panel at Pathology Visions 2011 many questions have come to mind. 

As a dues paying, card carrying member of the College of American Pathologists, I have benefited in many ways professionally being associated with the professional organization.  From the time I was a junior member I have served on a number of committees, working groups and ad hoc task forces.  As a member of the Informatics Committee many years ago was involved with writing the checklist questions for telepathology that are now part of the laboratory accreditation program.  We also put together a course on digital pathology, whole slide imaging and telepathology that remains current today.  Through the foundation I have helped plan the CAP Futurescape Conference and review grant submissions for resident travel awards.  The foundation serves many other purposes including humanitarian aid, patient education and research support that have helped many.  

Every lab I have worked in has been has been CAP accredited and I have been fortunate to inspect many. The process is professional, collegial and always informative.  The College does a fantastic job of doing its part to ensure labs are providing accurate results while being safe and orderly workplaces.  

Truth be told, I get a majority of my CME from the College's Performance Improvement Program (PIP) surgical pathology slide program.  Dollar for dollar and hour for hour, a very effective way to stay current, see great cases and learn effectively without the hassle of travel or meeting registrations although I do enjoy the annual CAP meeting and have supported this for many years.

There are dozens of other committees, education programs, meetings, courses, philanthropic activities, etc... that the College offers on behalf of its members and laboratories.

With all that being said, I wonder if the College did not do enough to keep the FDA from regulating whole slide imaging hardware and software.  

Did the College discuss with the FDA, pathologists innately conservative nature and need and necessity to self-validated any device, test or application within their laboratories?  Did the College mention the degree of scrutiny we as a specialty self-validate, inspect, re-inspect, check and re-check our product, whether a CBC report or an anatomic pathology report?  Pathologists have procedures to read the actual procedures for the specific test, instrument or procedure.  Sit in a committee meeting that is discussing linearity surveys and you can begin to get a sense of what I mean.  If you know the joke about the internist, pediatrician, pathologist and surgeon who go duck hunting you also understand how physicians in general and pathologists in particular know their limits and pick and choose the tools they use to do their jobs (even surgeons).  

Did the College mention to the FDA that like the microscope, even the oldest, crappiest, dirtiest microscope in the department, in the right hands has been used effectively for decades to help save lives and take care of people?  

And where is the FDA when it comes to the microscope?

Oh yeah, they do not regulate those. Something about one being older than the other. Most of us probably don't know if it is a xenon, halogen, incandescent or some other gas or filament producing the white light turned blue by filters, shown through a paper thin tissue section, through a lens, off some mirrors (not cleaned for a long time) and through some more glass to the back of our retinas is "calibrated", "validated" or "Kohler illuminated".  

What we do now is if the tissue section stinks or the microscope image being presented to our neurons stinks, we go back, check the fixation, cutting, staining, light source, lens, condensors, etc... to make it right and offer the best quality product for the most accurate diagnosis. 

Shoot, I took my pathology boards, the test used to say that one is "board certified" by reading digital slides and images.  There were some glass slides as well with rudimentary microscopes.  The monitors were low resolution CRT monitors but perhaps this was the test -- if you can diagnose these images and slides with this lousy technology, you can probably do it with better equipment where you are actually going to practice.  I didn't know you could zoom in on the images to a higher magnification and still passed.  I don't know whats worse - not knowing I could do this when I should have or passing the exam without having to...Before this the boards would show kodachromes.  Folks in the back of large rooms claimed needing binoculars to see the images across the room.  And they passed too.

The same would be true for a slide scanner and viewer, we may all not know if it is "line" or "tile" or took 2 minutes or 4 but we would use it as any other tool and expect it to present a diagnostic quality image to diagnose.  We would know enough to know a bad image or bad scan much like we know enough to know when a microscope lens that is not suppose to has oil on it, needs a bulb changed or has the wrong oculars on it because a resident or colleague swapped yours out for another.

In their letters to the FDA in October of 2009, Drs. Visscher and Schwartz (at the time a past president of the College and not yet named CMO at Aperio) eloquently make these points in the day to day surigcal practice of pathology with many decades of combined experience in large laboratories with many responsibilities in those laboratories.  In addition to the microscope, they mention other information that is used in making a diagnosis and the value adds for digital pathology in their environments.

Additionally, Dr. Juan Rosai in his letter to the FDA prior to that meeting, one of the world's foremost pathologists maintains that if he can use the technology for the most difficult consults from all over the world, "routine" cases, since they are "routine" could be diagnosed with digital pathology accurately, closing his letter with "I would simply conclude by saying than from a technical and scientific standpoint I am thoroughly convinced that a diagnosis made on the basis of a well-prepared digital image of a representative whole section is just as informative and accurate as that performed by using the time-honored examination of a glass slide under the binocular microscope."

Did the College stand up for pathologists and make this statement based on its many members, peer-reviewed works from the pathology community and the College's own internal efforts to help ensure this technology was implemented and used appropriately?

I of course do not know.  If since and before October 2009 these discussions took place, I do not think the CAP has shared its efforts widely with its members or did not have these discussions.  

In a subsequent post on this issue, I will offer a way in which the College of American Pathologists can help ensure this technology is marketed and used as it is intended in a safe and effective manner.