The “have computer will travel” capability that digital pathology affords can expedite diagnoses and care, but it also raises regulatory and legal questions.
One, says pathologist Peter Kolbeck, MD, is whether pathologists with home offices in which they view digital slides to make diagnoses require a CLIA certificate.
The answer, says Judy Yost, MA, MT(ASCP), director of the Centers for Medicare and Medicaid Services’ Division of Laboratory Services, is “yes, a pathologist reading slides at home requires a certificate. In histology, especially, we consider the pathologist’s diagnosis and interpretation of the slide [to be] the test.”
A CLIA certificate is also required for pathologists who interpret slides on their laptops in changing locations, such as airports and hotels, Yost adds. CLIA does, however, provide “a certificate exception that allows for ‘temporary’ testing sites.” That’s where “the work can be associated with a central lab certificate and not require a new one every time the location changes—that is, as long as the director of note on the central lab certificate permits this to occur,” Yost says.
Providing pathology diagnoses across state lines also raises licensure issues, though that’s true for glass slides or digital images. Certain states restrict out-of-state physicians from doing work on patients in that state without a license to practice medicine, says lawyer Jane Pine Wood, of McDonald Hopkins, Dennis, Mass.
In addition, Wood says, “some states require a lab to have a license in a state before examining patient specimens from that state—for example, New York and California, and New York in particular.”
Barry R. Ziman, CAP director of state affairs, says similar laboratory licensure requirements are applicable for out-of-state labs serving patients in Florida, Pennsylvania, Rhode Island, and Maryland.
If a state has a telemedicine statute, says pathologist Stanley Leung, MD, JD, of Metropolitan Medical Laboratory, Davenport, Iowa, “that language would govern what the pathologist does.”
A lot of states exclude consultation from the licensure requirement, Dr. Leung says. But “how consultation is defined tends to vary from state to state in terms of the frequency of consultation, etc., which could affect whether the pathologist needed a license in a state [to examine specimens from patients in that state],” Dr. Leung cautions. He co-authored with Keith Kaplan, MD, an article on medicolegal issues in telepathology published as part of a symposium and edited by Ronald Weinstein, MD, director of the Telemedicine Program at the University of Arizona (Hum Pathol. 2009;40:1137–1142).
Wood’s chief concern related to licensure has to do with its potential impact on malpractice cases. For example, she can foresee a lawsuit including an allegation of unlicensed practice of medicine. And if there were such a suit, that could “get the snowball rolling.” For one, the malpractice insurer could refuse to provide coverage for the case. “Or in a civil lawsuit, suddenly there are some criminal issues attached related to unlicensed practice of medicine,” Wood says.
Thus, a lab’s and pathologist’s safest tack is to check with each state. For example, the medical licensing board, Dr. Leung says, can direct the pathologist to the appropriate regulations, or there may be advisory opinions that speak to situations that the statute does not address.
Dr. Weinstein says the Arizona Telemedicine Program takes a conservative approach to regulatory and licensure issues. “We assist in getting medical licenses for our doctors who practice in states outside of Arizona. We also help get them credentialed at the hospitals where they are providing the telepathology or teleradiology services,” he explains.
The CAP’s policy on interstate licensure, says Gene Herbek, MD, CAP secretary-treasurer, supports the states’ rights to require licensure of physicians to diagnose and treat patients in their respective states. “We feel this is the best mechanism states have to ensure, as best they can,” the physician’s credentials, he says. The College’s policy does not advocate that pathologists have to obtain licensure to perform consultations with other pathologists, says Dr. Herbek, “since the responsibility for the patient’s final diagnosis lies with the referring pathologist.” (See “Licensure Requirements for Interstate Diagnosis, Including Interstate Telemedicine Practice” at www.cap.org.)
As for other legal issues, pathologists should keep in mind that they aren’t home free if a state does have an exception to the licensure requirement. The out-of-state physician, note Drs. Leung and Kaplan in their article, still has to follow the state’s medical practice laws, which include “privacy, incident reporting, financial interest disclosures, record keeping, informed consent, infectious disease, reporting malpractice suits, advertising, and continuity of care.”
A final note of caution: “If digital pathology has limited applications in certain clinical settings,” says Wood, “you don’t want to push the boundaries and do anything with it where the quality of the service is going to be reduced.”