Telemedicine: look before you leap - Liability and the Lab

Medical Laboratory Observer, April, 2003 by Barbara Harty-Golder

Q: The pathology group in charge of our laboratory is a large one, covering hospitals in several surrounding cities. Ours is one of the smaller labs. We usually see the pathologists several times a week, although they will come to our lab on an emergency basis for reviewing slides or for clinical consults. They are discussing the possibility of setting up a "distance-diagnosis" program for reaching out to physicians' offices in the area and for managing the demands of our lab. As I understand it, it's possible to transmit images of blood smears electronically, so that the pathologists can review smears or slides without having to go to the office or come here to the lab. What do we need to do to make sure this is set up properly?

A: Telemedicine is one of those technological leaps that promises to change the face of medicine. Particularly for those tasks that require interpretation of images (slides, graphs or x-rays), the ability to transmit the data from one site to another means that it will be easier than ever to ensure timely, quality care for patients. Like other technological advances, however, it creates a number of legal problems.

As you would with any new methodology, set up a system of parallel testing to ensure that the new technology will do what you want it to do, and that it will correlate well with previous, tried-and-true results. In this case, you will be transmitting an image to a remote site. Although in theory this sounds simple enough, most pathologists will admit that there's something special about looking at an image through a microscope. Transmitted images may lose sharpness; it may be difficult or impossible for the pathologist to focus through an area of interest; and, of course, selection of the area of the slide to be viewed will probably be left to someone else. Any of these possibilities may result in less reliability for the distance review when compared to the on-site examination. Only a rigorous trial that includes all manner of possible specimens can determine whether the technology is worth implementing in the first place.

If it passes muster, then it is time to pay attention to the legal details. Reading a slide, even at a distance, involves performing a service for the patient through the laboratory or the hospital to which the specimen was initially referred. If the laboratory is hospital-based, medical staff bylaws may require that the pathologist interpreting the specimen have hospital privileges. That is easy to ensure when the service is performed on site, but it is more difficult when done at a distance. Make sure that bylaws, policies and contracts clearly specify who may interpret material, and what documentation is necessary to memorialize the interaction and the interpretation.

Some hospitals will treat telemedical consultations as they do in-house services. If so, the pathologist rendering the services will generally have to be a member of the hospital medical staff, with all that entails. Others will manage telemedical consultations as they do referrals for outside or second opinions, in which case medical staff privileges may not be required. In addition, state laws will determine whether a physician rendering telemedical privileges must have a license to practice medicine in that state. Some states require such a nexus; others require only that the physician asking for the consultation be licensed in the state.

Because telemedical consultations involve patient care, the potential for malpractice exists. If state lines are crossed in the telemedicine consultation, your institution should be aware of the potential ramifications for any future lawsuits. Depending on your state and the circumstances, having a telemedicine consultant in another geographical area could change the place in which a suit is filed, the forum in which the case is heard and even the laws that will apply to the determination of the case. If the remoteness of the telemedical consultant means that it is difficult or impossible for primary care physicians to contact him to discuss the case, additional legal liability for the lab may result.

Telemedicine necessitates transmitting patient information over telephone lines or cables, and thus, is subject to the same HIPAA regulations as all other patient-care encounters. Depending on how the system is constructed, it will be necessary to integrate security safeguards, including passwords and possibly encryption. Business associate agreements may also be required. Record keeping may also require maintaining a computerized file of the transmitted images to ensure a record of what material was actually examined by the consultant.

Finally, all such business arrangements must meet the legal standards set by state and federal laws that regulate physician enterprise, such as the Stark provisions.

Barbara Harty-Golder is a pathologist-attorney in Sarasota, FL. She directs the clinical laboratory at Health South Rehabilitation Hospital in Sarasota, and maintains a law practice with a special interest in medical law. She writes and lectures extensively on healthcare law, risk management and human resources management.