Legal issues with mobile stroke units

shutterstock_157370876

A Sermo Neurologist shares about the legal issues with mobile stroke units.  If you’re a physician, please join us inside Sermo.

Mobile Stroke Units have become an emerging practical and intelligent solution to the problem of time—time, which limits the number of patients who can potentially receive IV-tPA. These mobile units travel to the locations of the patients who are possibly undergoing a stroke, wherein a paramedic and critical care nurse assess them, obtaining the various labs to prepare for tPA administration. A neurologist is also connected via a telemedicine portal to assess the patients and deem if they are potential candidates for tPA. As defined by the American Telemedicine Association (ATA), telemedicine is the “use of medical information exchanged from one site to another via electronic communications to improve patients’ health status.”[1] The efficacy and efficiency of telestroke have been borne out in data that have determined its utility in acute stroke settings, such as a greater use of thrombolysis, decreased rates of intracerebral hemorrhages, more optimal decision-making capacities, and efficient management of time.[2]   Although the use of the mobile units, and the prevalence and utility of telemedicine, in general, is clearly beneficial, they also subject the neurologist to malpractice repercussions. So how is the neurologist to navigate this murky terrain?

I will suggest that we extend this type of analysis into the elements of negligence (duty, breach, causation, and damages) that must be established to proceed with a successful medical malpractice claim and suggest a re-working of these factors in the context of telemedicine. Case law has established that a relationship, or duty, typically does not exist between a patient and consultant when the latter offers her informal opinion at the request of the primary physician. However, in a telestroke setting where a patient’s laboratory results, CT scan, and medical files would be readily available for the consultant neurologist, the above scenario must be modified. This greater degree and control over the patient is enough to establish a relationship, and hence duty, with the patient, although the patient has not been physically examined and is not an established patient whom the neurologist has previously seen in a clinical setting. In short, certain forms of telemedicine, which allow the consultant to view and diagnose imaging of a patient whom she does not physically see, do not alter rulings in existing case law that establish the requisite physician-patient relationship that has existed in such specialties, such as radiology.

Within a traditional medical setting, the physician will have breached her duty to the patient (the second element that must be established in a medical malpractice claim) if the physician fails to adhere to the standard of care for treatment or informed consent. The standard of care depends on the particular state and jurisdiction in which the physician practices. However, in a telestroke context, the issues pertaining to standard of care become problematic as state lines simultaneously blur and commingle. To which standard must the physician adhere? Since telemedicine does not respect borders, per se, does a national standard of care emerge? Is standard of care necessarily heightened due to the frailty of the technology and potential breach of data? Although most commentators have suggested that, in telemedicine, the standard of care must be held at a national level due to the flux of interstate medical care, some have advocated for a yet higher standard.

Telemedicine complicates the traditional notions of causation and damages, the third and fourth elements for a successful malpractice claim, insofar as it adds a mechanical and electrical component that may potentially disrupt medical care. Not only can negligence result from a physician’s errors, but, now, also from the technical failure of faulty equipment and the manner in which this equipment is utilized. Although negligence can still be delegated to the physician who makes an incorrect judgment, the mechanical and electronic aspects of the machine can now themselves be a cause for error. In such a case, the cause of the injury may solely reside in the equipment’s technical failure, which may absolve the physician, but not necessarily the Mobile Stroke Unit, from any medical negligence.[3]

The physician’s extent of control over a patient may also play a pivotal role in establishing causation in a telemedicine malpractice case. For example, if a consultant neurologist merely offers advice to the primary physician about a patient’s case and the latter has complete control over how he or she wishes to use this information, the telemedicine physician may not be held liable should injury occur. However, in the context of telestroke medicine in a mobile unit, the neurologist’s role may be deemed more active than a traditional consultant’s since the former has greater access via the audio-visual interface and radiological information in real time, making him or her a controlling presence in the patient’s medical care. Causation of injury may also be easier to prove in a telestroke setting where a patient is evaluated remotely. In this instance, the injured plaintiff can effectively argue that the strokologist simply could not perform an adequate and complete neurological examination in the telestroke encounter, and, if given an opportunity, could have, hence preventing, or, at the least, mitigating the damages.

Despite the potential for increased medical malpractice in a telestroke setting, the stroke specialist can offset her liability by adhering to certain guidelines.

First, she needs to ensure that the mechanical and electronic aspects of the telestroke apparatus (audio-visual conferencing, robotic interface, and so forth) are functional and that a back-up mechanism exists if data and images are lost during the initial, critical assessment of the patient.

Second, the strokologist should offer her advice and treatment options only if she is absolutely certain that the examination by the initial health provider has been performed adequately and that no data has been lost in the process of transmission.

Third, since the administration of IV-tPA may actually increase in a telestroke setting, the telestroke neurologist needs to accurately document the reasons for abstaining or treating the patient with this agent.

 

If you’re a physician, please join us inside Sermo.

 

[1] American Telemedicine Association, 2009, About Telemedicine (available online).

[2] Freeman W, Barrett K, Vatz K, Damaertschalk. Future Neurohospitalist: Teleneurohospitalist. The Neurohospitalist. 2012; (2):133.

[3] Phyllis Forrester Granade, “Medical Malpractice Issues Related to the Use of Telemedicine—an Analysis of the Ways in Which Telecommunications Affects the Principles of Medical Malpractice” 73 N. Dak. L. Rev. 65, (1997), hereinafter “Medical Malpractice.”