Several weeks ago on the family's annual pilgrimage to the pediatrician's office for the flu shot a friend of mine called me and asked if I was near a computer and if I could look at something online with him.
Never one to be too far from my laptop or willing to see a nice digital image of pathology slides I mentioned I could in a few minutes while waiting our turn at the pediatrician's office for the flu shot.
So, armed with laptop, my personal Mifi 2200 card and a few minutes, I was able to view in real time the effect of changing the gamma on some scanned cytology slides.
The value of Pathology 2.0 – digital pathology combined with other taken for granted technologies that provides the world at your fingertips – anytime, anywhere collaboration in a few minutes between a cellular phone call and waiting for the flu shot.
The question here of course is whether, if this were a "real" case, could I review the images and make an opinion based upon the images presented to me standing, waiting in a doctor's office.
Technically, I am in a doctor's office, or at least the waiting area. A real doctor. One that sees actual patients in their entirety – mainly their right or left arm this particular clinic, rather than just representative slices of their tissues.
The short answer – for primary diagnosis (let's for the sake of argument leave out "H&E" from these words) based on guidance from the FDA and CLIA earlier this month appears to be no. As a consult, I think the guidance is this use case is reasonable and presents less potential risk and potentially huge benefit not otherwise possible as an intended use.
"Hey, I have an interesting case I would like to show you – are you near a computer?"
"Sure, let me just turn off the football game, go into my home office with my radiology-grade monitor I actually picked up on eBay from a teleradiologist and review the case with you."
Anyways, I was able to view crisp, clear images quickly and accurately, outside of my office and was comfortable with the images being representative of the glass slide.
If we don't control the environments we conduct these practices in, regulatory efforts will tell us how to conduct them (enter CLIA '88).
Recall the history of CLIA – beginning in 1987, a series of newspaper and magazine articles were published on the quality of laboratory testing. Also, simultaneously television programs were aired concerning the number of laboratories that were not subject to either federal or state regulations. Congress held hearings in 1988 and heard testimony from “victims” of faulty laboratory testing. Specific concerns were raised about the validity of cholesterol screening and the accuracy of Pap smear results.
Section 4064 of the Omnibus Budget Reconciliation Act of 1987 [OBRA-87 – Public Law 100-203], enacted on December 22, 1987 amended Section 1861(s)(11) to require physician offices that performed more than 5000 tests per year to meet regulations. Laboratory testing in both physicians’ offices (POLs) and rural health clinics that did not accept and perform tests on referral specimens would not be subject to these revisions because both the Medicare and CLIA statues [Section 1861(s)(11) of the Act and section 351(I) of the PHS Act] respectively precluded the regulation at that time of POLs and RHC that performed tests only for their own patients.
On October 31, 1988, Congress enacted Public Law 100-578 in response to the congressional hearings. PL 100-578 greatly revised the authority (PHS Act) for the regulation of laboratories.
This law revised section 353 of the PHS Act (42 U.S.C. 263a) amending CLIA-67 by expanding the Department of HHS’s authority from regulation of laboratories that only accepted and tested specimens in interstate commerce to the regulation of any laboratory that tested specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.
Then on December 19, 1989, Congress enacted OBRA-89 (Public Law 101-239). Section 6141 removed the provision under section 4064 of OBRA-87, which would now require certification of all laboratories performing tests. In addition, it required laboratories participating in the Medicare/Medicaid programs to comply with CLIA-88 requirements.
On February 28, 1992, the final regulations for CLIA-88 were published with an implementation date of September 1, 1992. Sections of the CLIA requirements were to be phased in allowing previously non-regulated laboratories to become accustomed to the regulations. The regulations adding Provider-Performed Microscopy Procedures (PPMP) were published on March 24, 1995. Work is currently in progress with the CDC and CMS to develop final CLIA regulations, which will reflect all comments received since the September 1, 1992, Federal Register publication and the development of new technologies.
On April 24, 2003, the revised CLIA regulations went into effect.
Anyways, the question here for consideration when viewing images remotely, outside a defined laboratory is what defines a laboratory or doctor's office. Would a quiet, controlled setting with adequate technical resources to perform the test (in this case — review the slide) be sufficient?
Of course most of us recognize that while you could do this on a boat, at the beach or on a golf cart, reasonable pathologists would not do this. They might take blood bank or toxicology calls but not review images. Most practicing pathologists have been called away from meetings, outdoor activities, dinners, movies, shows, etc… to do just this. It's not that they are technically unable to do it, it is just that they have it done it yet. Physicians don't take night and weekend call from their offices. It kind of defeats the purpose of being "on call". Even before cellular devices and remote access to hospital network applications.