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Malpractice Issues in Radiology |
1 Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076, and Rush Medical College, Chicago, IL 60612.
Received October 21, 2002;
accepted after revision October 22, 2002.
Address correspondence to L. Berlin.
The Case
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When admitted to the hospital's emergency department, the patient appeared to be conscious but inebriated. He was thrashing about and was restrained on the ambulance cart. On being questioned by an emergency department physician, the patient admitted that he had been drinking but denied having lost consciousness or experiencing pain. Physical examination conducted by the emergency physician disclosed no neurologic deficits. Sensory and motor function of all extremities appeared to be normal.
The emergency physician followed a hospital protocol for cervical spine trauma that called for an initial cross-table lateral view of the cervical spine with the neck collar in place. This radiograph was obtained and interpreted by a radiologist as normal. At that point, in keeping with the hospital's protocol, a radiology technologist carefully removed the neck collar and proceeded to obtain anteroposterior, open-mouth, lateral, and two oblique views of the cervical spine, all with the patient lying on the radiology table. The radiologist interpreted this study as, "Limited examination because of patient's inability to cooperate for positioning and hold still. No obvious fracture or dislocation is seen."
The patient was admitted to the hospital for observation and was assigned to a room in a surgery ward. A ward nurse noted in the medical record that the patient appeared inebriated and, because he was "unable to follow orders" and was "thrashing around," was placed in restraints. Within a few minutes the patient was examined by a hospital-employed house physician. She found no abnormalities and reported this by telephone to an attending physician under whose service the patient had been admitted. The attending physician, who was at home, suggested that the patient be allowed to "sleep it off" during the night. Later that night the patient reported to a nurse that his arms and legs were "beginning to feel numb" and he was having difficulty moving them. The nurse noted this in the patient's chart but did not notify the house physician or the attending physician.
The following morning the attending physician examined the patient and found "profound sensory and motor loss" below the patient's neck. He immediately ordered a CT scan and called a neurologist for consultation.
The CT scan was obtained and interpreted by a radiologist as disclosing fractures of C5–C6 facets on the left with anterior subluxation of C5 on C6.
Because no neurosurgeon was readily available, the attending physician and the neurologist arranged to have the patient transferred immediately by ambulance to a university hospital. There the patient underwent surgery, during which the cervical spine subluxation was reduced and a fusion performed. The patient recovered from the surgery but remained permanently paraplegic.
Three months later, the patient filed a malpractice lawsuit against the hospital, the emergency department physician, the attending physician, the house physician, and the radiologist who had interpreted the initial cervical spine radiographs.
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During the discovery period, numerous records were examined and depositions taken that related to the conduct of the various defendant physicians and hospital nurses. For purposes of this article, I shall focus only on the testimony related to the defendant radiologist.
A radiology expert witness retained by the plaintiff testified at a deposition that the defendant radiologist who had interpreted the initial cervical spine radiographs breached the standard of care for failing to call for an immediate CT scan. The plaintiff's expert asserted that the defendant radiologist should have telephoned the emergency department physician and apprised him of the need for CT on the basis of the fact that the standard of radiologic care in the United States regarding evaluation of cervical spine injuries had "changed over recent years, moving from plain radiographs to helical CT." The expert pointed out that it was "common knowledge within the radiological community" that "a great many cervical spine fractures are missed on plain radiography and are seen only by CT." When cross-examined by the attorney representing the defendant radiologist, the plaintiff's radiology expert acknowledged that he could find no abnormalities on the radiographs of the patient's cervical spine, but then added, "that was all the more reason for the defendant radiologist to have ordered a CT scan."
The defendant radiologist and a radiology expert retained by the defense attorney each testified that no standard of care required a radiologist interpreting cervical spine radiographs to order a CT examination unless that radiologist observed a suspicious finding that needed further analysis. Both stated that it was the duty of the examining physician, not the radiologist, to order a CT scan if that physician believed it was clinically indicated. "It is the clinician, not the radiologist, who examines the patient and has before him or her all of the medical data to determine whether a CT is required," asserted the defense's radiology expert.
As the discovery proceedings came to an end, the attorneys defending the five codefendants, along with the claims managers of the involved malpractice insurance companies, met to decide their course of action. They concluded that because the defense would have virtually no chance to prevail at a jury trial, they should undertake negotiations with the plaintiff's attorney to settle the lawsuit. Although the other four codefendants readily agreed to pursue settlement, the co-defendant radiologist refused to enter into settlement discussions, believing that he had not breached any standard of radiologic care. It was explained to the defendant radiologist that if all the other codefendants agreed to a settlement, he might well find himself the only defendant at a trial that could end with a jury rendering a multi-million dollar verdict to be borne totally by the sole defendant. Only then did the defendant radiologist reluctantly agree to join in an overall settlement. The lawsuit was ultimately settled for a total of $8 million, $1 million of which was allocated to the radiologist.
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The questions of which patients should undergo imaging and, for those who do, what radiologic modality should be used, have challenged radiologists and nonradiologists alike for decades. Attempts have been made to minimize unnecessary radiologic examination of patients who have sustained cervical spine trauma. In 1998, the National Emergency X-Radiography Utilization Study was undertaken to formulate a decision instrument to identify patients with an extremely low probability of spinal injury [3]. The study investigators identified five clinical criteria—absence of midline cervical tenderness, normal level of alertness, no evidence of intoxication, absence of focal neurologic deficit, and absence of painful distracting injury—as factors that should all be present in patients who have sustained blunt trauma in order to eliminate the need for cervical radiography. Recently, Stiell et al. [1] developed the Canadian C-spine Rule that holds promise of becoming a safe and reliable tool that can lead to the appropriate use of radiology for patients at low risk of cervical spine fracture or cervical cord injury. Although the determination of indications for imaging of patients who have sustained cervical spine trauma is normally addressed by nonradiologic clinicians, the determination of the type of imaging that should be performed has historically fallen within the purview of the radiology community. As imaging has become more sophisticated, particularly with the many advances made in CT and MR technology, recommendations for the kind of radiologic examination that should be performed have changed accordingly. A brief review of how recommendations for the initial evaluation of cervical spine trauma have changed is in order.
The clinical decision as to which patients who have sustained cervical spine trauma should undergo radiologic examination has been dramatically affected by the widespread use of spinal immobilization protocols by emergency medical service personnel at the accident scene. Although these prehospital protocols undeniably prevent or minimize many serious spine injuries, the presence of the cervical spine collar has had the effect of raising the index of suspicion for cervical spine injury so high that virtually all patients with trauma to the neck are ordered to undergo imaging by emergency department physicians [4]. As to the specific nature of the radiologic examination, Mirvis et al. [5] in the late 1980s recommended that the primary radiologic study of patients who had sustained cervical spine trauma consist of a single cross-table lateral view, along with anteroposterior, lateral, and open-mouth radiographs, sometimes supplemented by oblique views. Those researchers acknowledged, however, that conventional radiographs detected fewer than half of spine fractures that were ultimately discovered by CT. Vandemark [4] claimed that well-positioned and optimally exposed radiographs of the cervical spine will disclose 95% of clinically significant cervical spine fractures, but lamented that, unfortunately, such high-quality examinations are frequently impossible to obtain. He also pointed out that those patients who are at the highest risk of injury are the ones most likely to have technically compromised cervical spine radiography. Nevertheless, notwithstanding its limitations, conventional radiography remained the mainstay for initial cervical spine screening until the early 1990s [6].
In 1996, Nuñez et al. [7] reported that nearly 40% of cervical spine fractures are missed on conventional radiography but are later revealed on CT. One third of these patients had either clinically significant or unstable fractures. As a result, Nuñez et al. incorporated helical CT of the cervical spine into the routine evaluation of high-risk patients. Patients were classified as high risk if they exhibited certain clinical criteria based on mechanism of injury such as a high-velocity accident, associated injuries such as multiple fractures or visceral lesions, and impaired sensorium. Notwithstanding the increased sensitivity of CT, such researchers as El-Khoury [8] and Daffner [9] at the time urged caution with regard to using CT routinely in cervical spine trauma because of its unproven value and high cost.
In 1995, the American College of Radiology (ACR) published its Appropriateness Criteria for Imaging and Treatment Decisions [10]. The section entitled "Cervical Spine Trauma" states:
There is good evidence that there is no need to examine patients radiologically if they are asymptomatic with regard to their necks.... The pervading opinion is that AP, lateral, and open mouth views which demonstrate all seven cervical vertebrae are adequate. A swimmer's view may be added if C7 is not adequately demonstrated.
Patients with cervical pain and suspected ligamentous injury and with normal radiographic examination should have flexion and extension views, particularly if there is prevertebral soft tissue swelling. Filming in the erect position is preferred since it better demonstrates instability....
There is information that in specific cases, oblique projections have been able to demonstrate fractures which are not detectable in frontal and lateral projections and are valuable additions to the workup.
CT was recommended only when screening conventional radiographs raised the question of craniovertebral injury (occiput to C2 level).
In 1998, Nuñez and Quencer [11] suggested that the ACR appropriateness criteria be reevaluated because helical CT, with its faster acquisition of volumetric data, even when used alone, had shown a sensitivity of 98% for fracture detection. Nuñez and Quencer recommended that helical CT be used on all high-risk patients and on all low-risk patients whose radiographs reveal equivocal findings or incomplete visualization of any portion of the cervical spine. Claiming that relying exclusively on radiography to determine that the cervical spine was free of injury caused too much delay, those researchers proposed that patients who would be undergoing CT of the brain or abdomen for evaluation of other injuries should automatically undergo CT of the cervical spine as well.
In a 1999 review article on cervical spine trauma, LeBlang and Nuñez [12] suggested that it may be more appropriate to perform CT of the cervical spine even before a full radiographic examination is performed. They also proposed that the ACR appropriateness criteria be modified, inasmuch as the criteria were published before helical CT became widely used in the radiology community. Although acknowledging that conventional radiography remained the generally accepted modality of choice for the initial evaluation of suspected cervical injury, those researchers pointed out that multiple radiographs must frequently be obtained because of difficulty in adequately visualizing the proximal and distal cervical regions. The use of helical CT for the initial evaluation of suspected cervical trauma, contended those researchers, offers two advantages. It allows faster exclusion of injuries and expedites patient management, and it detects more fractures and important injuries that were missed by radiography.
Pointing out that 10,000 persons sustain spinal cord injury in the United States each year, at an estimated annual cost to society of $3.4 billion, and acknowledging how difficult it is to predict the presence of cervical spine fractures in the absence of imaging, Blackmore et al. [13, 14] investigated the cost-effectiveness of CT relative to radiography for cervical spine screening in trauma patients. Those researchers divided patients who sustained cervical spine trauma into three groups—high-risk, moderate-risk and low-risk—and then determined the potential fracture risk of each group. The high-risk patients include those who sustained severe head injury, those with focal neurologic deficits, and those older than 50 years with a high-energy mechanism of injury; this group has an anticipated cervical spine fracture risk of 11.2%. The moderate-risk group, with a fracture risk of 4.2%, includes those patients 50 years or younger with a high-energy mechanism of injury and patients older than 50 years with a moderate-energy mechanism of injury. In the low-risk group, having a potential fracture risk of 2.1%, are patients 50 years or younger with a moderate-energy mechanism of injury. Those researchers concluded that CT is the standard of care for evaluation of trauma patients with injuries to the head, chest, abdomen, and pelvis. They also advocated that CT be accepted as the screening method of choice for initial evaluation of high- and moderate-risk patients who have undergone cervical trauma. They did not believe that CT is cost-effective for screening low-risk patients, in whom the fracture risk is less than 4%. In a later report, Hanson et al. [15] reaffirmed the principle that patients with a greater than 5% risk of cervical spine fracture should undergo helical CT, adding that it is the diagnostic yield for unstable injuries that determines the rate of avoidable neurologic deficits and thereby the justification for CT screening.
Other researchers have addressed the issue of whether radiography is required in cervical spine trauma when helical CT is performed in routine screening. Rybicki et al. [16] concluded that notwithstanding the value of CT, the lateral radiograph remains an essential and fundamental part of cervical spine imaging because of its value for assessing the prevertebral soft tissues and vertebral alignment and for evaluating foreign bodies. They also pointed out that the lateral view can reveal subtle end-plate fractures and distraction injuries that can be elusive on CT.
In 2000, Daffner [17] published the results of a study comparing radiography with CT for examinations in cervical spine trauma. Radiographic examination times ranged from 5 to 46 min, with an average of 32 min. CT examination times ranged from 3 to 30 min, with an average of 12 min. Forty-five percent of patients required one or more repeated radiographs for satisfactory examination. Contending that anything that delays treatment, such as a prolonged radiographic examination time, can have a deleterious effect on the patient, Daffner concluded, "It makes little sense to repeat films and consume time when another method, helical CT, is available for the same purpose." One year later, Lawrason et al. [18] delved into the question of whether lateral screening radiography of the cervical spine adds any useful data to what can be discovered by CT. They concluded that such radiography does not.
Just this past October, Rybicki et al. [19] addressed a major downside to the indiscriminate use of CT and radiography for cervical spine trauma that had previously received little attention: radiation. Those researchers measured radiation dose, finding the mean skin dose for CT of the cervical spine to be 27.2 mGy, in distinction to the mean skin dose for radiography, which is 2.89 mGy. The radiation dose to the thyroid gland from CT of the entire cervical spine was 14 times greater than that delivered to the thyroid by radiography. Rybicki et al. emphasized that caution should be used when considering whether CT or radiography of the cervical spine should be performed because thyroid radiation is greater with CT, particularly among the subset of patients who are young and otherwise healthy. In short, concluded Rybicki et al., the radiation dose of the thyroid should be factored into the judicious use of helical CT in routine screening for suspected cervical spine injury.
Standards of medical care do not derive exclusively from external authorities such as government or professional societies, but rather from interaction among leaders of the profession and networks of colleagues, reports in the literature, and educational seminars; it is a decentralized process [20]. An important component in the determination of what constitutes the standard of care are those formally codified and published standards or guidelines promulgated by governmental agencies, professional societies, and local health care facilities. These written standards of practice bear directly and exert great influence on judges or jurors who must determine whether a particular defendant radiologist in a given malpractice case has breached the standard of care. Because the ACR is clearly recognized as the preeminent professional society of radiologists, it unquestionably exerts more influence than any other single organization on what the medical and legal communities perceive to be the radiology standard of care. Relative to the question of whether radiography or CT should be performed in cases of cervical spine trauma, the ACR Standard for the Performance of Radiography of the Cervical Spine in Children and Adults, January 1, 2000, revision, states [21]:
Based on the clinical assessment and/or evaluation of the radiographs, further examination of the cervical spine with CT or Magnetic Resonance Imaging (MRI) scanning may be indicated.
Standards of medical care are constantly in a state of flux. Radiologic standards are certainly no exception, as illustrated by certain examples that have been discussed previously. The standard of care related to a radiologist's communication of results to physicians and to patients has undergone considerable change over recent years [22]. The standard of care related to the radiologic modality of choice in screening patients for the presence of urinary calculi has shifted from excretory urography to CT over recent years [23]. The standard of care as to whether conventional radiography or abdominal CT should be used to screen patients who present to emergency departments with abdominal pain has shifted from conventional radiography to CT in recent years [24].
It appears that there may be a comparable shifting of the standard of care relating not so much to whether radiologic imaging ought to be performed for patients who sustain cervical spine trauma—for it seems well established that virtually all high-risk and moderate-risk patients ought to undergo some kind of imaging—but rather to what kind of imaging should be performed. The advent of helical CT has accelerated this shift.
It cannot be categorically stated that the standard of radiologic care requires that all patients who sustain cervical spine trauma be examined by helical CT in lieu of or in addition to radiography. The case presented in this article, in which a defendant radiologist was alleged to have violated the standard of care by failing to request a CT scan as part of his radiographic cervical spine interpretation, raises questions that cannot be readily answered. Does a radiologist have the responsibility of recommending that CT examination be performed in all cervical spine injuries, regardless of whether a radiographic examination has been requested? Does the referring physician have such a duty? One commentator has stated that the task of detecting cervical spine injuries in the trauma patient is primarily the responsibility of the radiologist [8], but neither a consensus of opinion in the radiology community nor an appeals court decision focusing on these questions has yet occurred.
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The following pointers will assist radiologists in dealing with the question of whether radiologists have a duty to recommend or perform CT in patients with cervical spine trauma. Risk management regarding standards of practice can lessen the likelihood of incurring a medical malpractice lawsuit and maximize chances for a successful defense if such a suit is filed. Such risk management can also enhance good patient care. The following risk management pointers will help radiologists meet all three of these objectives.
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