When does deviation from treatment guidelines constitute innovation in the standard of care? On 1 level, the decision in the report by Vojtko and Hanfling to use a FAST 1 intraosseous access needle in a patient with extensive burns can be viewed as clear deviation from the manufacturer's guidelines for use of their device. However, in the case described, adequate vascular access could not be obtained by other means, and the patient's immediate condition was severely compromised as a result. Consequently the paramedics' decision to use the FAST 1 before transport was in the best interest of their patient and entirely logical. Furthermore, the clinical improvement achieved with volume replacement through the IO route, subsequent successful transport to medical care, and the patient's survival all support the validity of the decision.
Fortunately, in spite of the skin over the sternum being severely burned, there were no subsequent infectious complications at the insertion site, and staff at the receiving hospital were able to remove the FAST 1 needle without difficulty. Thus in this scenario, all the important outcomes were favorable. So on another level, “irregular” use of a FAST 1 device can be seen as innovation.
Primum non nocere (first do no harm) is a legitimate cornerstone in medical care. In consequence, most of the care provided in an EMS prehospital context is protocol driven, and medical oversight dialogue, where available, makes it possible to extend or modify the treatment guidelines in place. Because most protocols are carefully conceived and evidence-based where possible, a process that monitors the incidence and effect of protocol deviation is a valuable quality assurance measure.
Salerno,1 in a series of 1246 ALS ambulance calls, found that 16% involved protocol deviations. Most of these deviations occurred without dialogue or the consent of medical control. Fifty-five percent of deviations were minor, 38% were serious, and 7% were very serious. However, 89.5% of these patients were unaffected by the deviations from protocols, 5% actually improved, and 5.5% suffered complications, most of which were minor. Quality assurance of this type is valuable and enables education to occur and contributes to improvement of treatment guidelines where weakness is evident in the existing protocols.2
In the air medical transport environment, some teams have defined protocols, but most have treatment guidelines with significant flexibility in decision-making. Consultation with a physician overseeing the call is usually implicit in their pattern of practice because most care provided constitutes delegated medical acts. Sometimes circumstances are such or a case sufficiently complex that thinking outside the box and being innovative are essential for a patient to be transported successfully.
Strictly speaking (ie, from the standpoint of a transport medical director), a physician should be consulted before deviation from a protocol or device guideline occurs in each individual case. Although such discussion affords important medical and medicolegal support, it also must be recognized that physician oversight itself may cause or contribute to protocol deviation and errors of judgment.1 It is of greater relevance that during many transports dialogue with a physician is not always feasible, and where the immediate well-being of an actual patient is in jeopardy, the price of innovation requires that we accept the element of risk associated with irregular decisions made independently by transport personnel.
Clearly, such acceptance in no way endorses cavalier behavior or careless disregard for existing protocols, manufacturer's guidelines regarding drugs and equipment, or specific directives obtained from medical oversight. For deviation to be innovative, it is essential that the welfare of the patient drives every decision and that each caregiver acts entirely in the patient's best interest. It is also necessary that all the circumstances surrounding the deviation are documented to limit liability3 and important to ensure that what has occurred is shared fully in an educational context.
Hippocrates4 could have been talking about air medical transport when he said, “For extreme illnesses, extreme treatments are most fitting.” Certainly this applies to the case Vojtko and Hanfling report. However, it is important that we share with our peers the failures as well as the successes of cases involving irregular decisions. While it is possible that only a small percentage of protocol deviations are harmful,1 there is insufficient evidence in the literature to be certain.
Consequently, whether we call it quality assurance, research, or the acquisition of data on which to base our practice, it is essential to learn the positive and negative lessons from what is done and what is not done. Then, if we are truly innovative, this process is followed by constructive change, as following George Washington's advice, “We weigh the pros and cons and reason prevails.” In other words, thoughtful and hopefully evidence-based review leads to improved guidelines, protocols, medical oversight, and treatments that enhance the quality and comprehensiveness of the care we provide patients who require transport.
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