A couple of weeks ago I wrote a note about a lawsuit involving Mayo Clinic that now involves the Justice Department for alleged fraudulent billing practices @ Mayo Clinic among other allegations (see: Suit Alleges Mayo Overbilled for Pathology Services, Justice Department Joins Suit) in response to inquiring minds on the matter.
Again, I only know what is being report largely from a story in a Pittsburgh newspaper. One part of the suit alleges that Mayo failed to comply with federal regulations that require clinical lab to retain pathology slides for 10 years.
As far as I know slides produced at Mayo (sans consult slides returned to contributors) were retained indefinitely. I do not know what period of time the suit covers about slides not being retained.
For the sake of argument, I presume the neurologist and attorney, David Ketroser, has some grounds for the lawsuit.
Given the technical nature of the frozen section process I wrote about previously and the fact that water based stains without permanent cover slips do not make for easy storage or subsequent review, how could this situation have been mitigated?
These types of slides I think are a perfect application for whole slide imaging. We could argue whether doing so, that is capturing a reproduction of the slide as a digital image qualifies for "slides retained" per College of American Pathologist guidelines but this provides a basis for the discussion.
- Example of frozen section slide stained with toluidine blue showing cholangiocarcinoma with perineural invasion.
If the alternative is not being able to either retain or accurately review the slides when necessary years later, a digital replicate of the slide itself may be the next best solution. As is commonly agreed within the digital pathology market, the images are consistent, persistent and efficient. The slide and hence any images viewed from it are as close to the "real thing" as the original glass slide at time of frozen section.
Critics will argue of course of the need to scan every frozen section without knowing which ones may become important years later. And retaining those images for a period of 10 years. During the 10 years the volumes and number of slides produced may increase in a given lab, further compounding the storage solution. Fortunately, immediate availability would likely not be a requirement so hosted storage or disk backup may suffice. There would have to be a mutual understanding with the CAP that this meets the regulation. For that to occur, adoption has to become more widespread and the practice validated.
Nonetheless, in cases such as frozen sections, clinical microbiology examinations and rare event type detections (i.e. AFB smears with rare organisms, malaria smears), fluorescent preparations and where material may be limited (i.e. cytology slide with rare malignant cells or 1 diagnostic slide without corresponding tissue in block or slide form), a digital reproduction, vis-a-vis, a whole slide image may be as appropriate for subsequent review when necessary.
- Example of blood smear with malaria