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Four cases illustrate common errors that can lead to litigation when performing obstetric and gynecologic ultrasound.
Look at the images
A patient underwent four ultrasounds during her pregnancy. The sonographer remarked that in three of the studies, there were, “Structural irregularities that require further evaluation.” The physician notified the patient that the ultrasounds were normal. The baby was born with a midline facial defect, cleft palate, club foot, and lower-limb anomalies. The child has limited cognitive and communication skills. During litigation, the physician admitted that he had not reviewed the images from the studies or the sonographer’s handwritten report about the findings.
A $1.9 million settlement was reached prior to trial.
Unfortunately, it is not uncommon for physicians to rely on the sonographer’s “report” and fail to personally review the images. Although sonographers are responsible for obtaining appropriate images, interpreting ultrasounds is beyond the scope of their professional practice. Interpretation of studies and associated recommendations are the responsibility of the physician. Physicians should review study images and either scan the patient themselves or refer the patient to an imaging specialist for further evaluation and diagnosis.
Documenting and reading the report carefully
A 28-year-old G3P2002 presented to her physician at 16 weeks, 4 days with a history of oligomenorrhea and two prior cesarean deliveries. Her estimated date of delivery (EDD) was 4/10/XX. Because of the woman’s body habitus, the physician was unable to palpate the uterine fundus. Fetal heart tones were documented at 160 beats per minute. The patient was referred for an ultrasound, which was performed at 17 weeks’ gestation by dates and consistent with 9 weeks, 4 days’ gestation. The report stated, “Live, intrauterine pregnancy with a gestational age of 9 weeks 4 days + 6 days. The EDD is 4/10/XX. No abnormalities visualized.” The EDD should have been 6/2/XX but the report showed the original EDD, rather than the new one. No further ultrasounds were performed during the pregnancy.
On 4/05/XX, the patient delivered a 1710-g male infant via cesarean, who had Apgar scores of 9 and 9 at 1 and 5 minutes, respectively. The baby’s Ballard score was consistent with 31 weeks. He suffered unusually severe complications of prematurity with severe respiratory distress syndrome, bronchopulmonary dysplasia, and necrotizing enterocolitis requiring surgery.
Deposition of the defendant obstetrician revealed repeated exam inconsistencies and poor documentation. For example, the patient was seen for abdominal pain at 23 and 2/7 weeks by dates and 15 and 5/7 weeks by ultrasound. The only documentation of the examination was “Uterus is normal.” There were repeated discrepancies between the fundal height and the estimated gestational age. The plaintiff’s expert witness testified that the ultrasound report erroneously reported the estimated date of delivery, the primary obstetrician should have recognized this discrepancy and the persistent discrepancy in the fundal height and gestational age and ordered a repeat ultrasound.
The case settled for $980,000 prior to trial.
Imaging specialists must construct their report to alert referring physicians to significant sonographic findings or notify the referring physician of them personally or through their appropriate delegate, such as that physician’s nurse. Recommendations for further studies are integral to a complete report. For example, in the referenced case, a preferred report follows:
The estimated gestational age by ultrasound is 9w4d. This is not consistent with the estimated age by dates. ACOG recommends adjusting the EDD if the discrepancy is more than 7 days when the gestational age is between 9w0d and 13w6d. Thus, the EGA should be adjusted to 9w4d, with an EDD = 6/03/XX. The adjusted EDD should be confirmed on subsequent ultrasound studies. Consider a nuchal translucency at 11-14 weeks. An anatomic survey is recommended at 18-20 weeks EGA.
The final written report is considered the definitive means of communicating the results of an imaging study or procedure. Direct or personal communication must occur in certain circumstances, such as major fetal anomalies or findings that immediately impact management of the pregnancy. The primary obstetrician must read the entire report and correlate the ultrasound findings with the clinical findings. Inconsistencies require further investigation or imaging.
Be careful about what you DO NOT document.
A 33 year-old G3P2002 underwent an ultrasound at 19 and 1/7 weeks’ gestation. The ultrasound reported stated, “Normal ultrasound with fetus at 19 1/7 weeks of gestation.” No further ultrasounds were performed. At 39 weeks’ gestation, the patient delivered a baby with Down syndrome. An expert review of the ultrasound revealed mild pyelectasis with calyceal dilatation of 4.3 and 4.4 mm. In addition, an echogenic intracardiac focus was identified. At trial, the radiologist testified that the practice rounds to the nearest whole number. Thus, the calyceal dilation would have been 4 mm and within normal limits. Further, an echogenic intracardiac focus is a worthless marker and of no consequence. Thus, the ultrasound was normal.
It is the obstetrician’s duty to recommend further testing to the patient. The obstetrician testified that the ultrasound was reported as normal and he had no reason to recommend amniocentesis or further ultrasound studies. The plaintiff’s expert testified that calyceal dilatation > 4 mm at 19 and 1/7 weeks’ gestation warrants a repeat ultrasound at 32 weeks to evaluate for persistence of the calyceal dilatation. As an isolated finding, an echogenic focus is poor marker for Down syndrome. However, when multiple soft markers for Down syndrome are identified, they should be noted in the report and recommendations made to recalculate the patient’s risk with amniocentesis, if indicated. A repeat ultrasound should have been recommended.
The jury found as follows:
Obstetrician: Defense verdict
Radiologist: Plaintiff verdict. The radiologist had a duty to report the findings to the obstetrician. If he had done so, the duty for further counseling, evaluation, and treatment would have transferred to the obstetrician.
Imaging specialists, regardless of their specialty, should report all visualized abnormal findings, recommending clinical correlation and further studies as indicated. Significant or concerning findings may require direct communication with the referring physician or his or her delegate. Further, this case demonstrated a rather common error made during trial: One defendant criticizes the care or blames the outcome on another defendant. Such actions render a case virtually indefensible. Defendants should not act as experts for the plaintiff. At trial, a defendant should confine his or her testimony to their actions and rationale, while avoiding criticizing the care of others.
Be careful what you bill and how you document
A radiology group routinely performs and bills for transabdominal and transvaginal ultrasound (TVUS) studies in all patients referred for a pelvic ultrasound. They came under scrutiny for billing fraud, for inappropriately billing for both studies in all patients, particularly as they could not identify an order requesting both studies from referring physicians.
The Department of Justice fined the group $10 million for performing “unnecessary procedures.”
Many ultrasonographers opine that the standard of care requires the performance of both an abdominal and a vaginal sonogram at the time of pelvic ultrasound. This is not the standard of care. Certainly, if all relevant anatomy cannot be identified with one approach, appropriate evaluation requires the additional approach. Whether a specific order is required is controversial. If a practice performs its own ultrasound studies, this is a minor issue, as the providers are readily available to confirm the need for additional study. However, imaging specialists who see many referred patients face greater obstacles, particularly in the era of electronic health records and electronic orders.
Several recommendations can be made for ordering, reporting, and billing. (See Sidebar: Options for overcoming the issue of performing studies without appropriate orders)
Incorporating language like what is shown in the sidebar into the electronic reporting system can facilitate its inclusion in an ultrasound report.
Billing for both studies must be appropriate. For example, if an ovary not seen on TVUS could be visualized on abdominal ultrasound, it would be appropriate to bill CPT 76830 (Complete evaluation of the female pelvic anatomy-vaginal study) and CPT 76857 (Ultrasound, pelvic [non-obstetric], real-time with image documentation; limited or follow-up).1 Billing for CPT 76856 (Complete evaluation of the female pelvic anatomy-abdominal study) should not be done unless all elements of the abdominal ultrasound are performed.
These elements include:
Inaccurate or inappropriate billing may present greater financial risk than medical liability. The physician is ultimately responsible for submitting the correct bill. Delegating coding for procedures increases the risk of error, for which the provider is liable. Electronic health records highlight another risk of possible fraudulent billing. Including the documentation for a management consult in the ultrasound report is not adequate for the purpose of billing an evaluation and management (E&M) code. Documentation in a separate progress note should be performed when billing an E&M code, in addition to the CPT code(s) for an ultrasound study.
These cases illustrate common errors leading to litigation when performing obstetric and gynecologic ultrasound. Underlying each scenario is proper documentation of the ultrasound findings. Findings should be recorded and results communicated consistent with the AIUM Practice Parameter for Documentation of an Ultrasound Examination.2 Applying the discussed recommendations is no guarantee that a physician will not be held liable for such errors. Applying these best practices, however, will enhance the defensibility of such cases.