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    Liability in ob/gyn ultrasound

    Adhering to best practices for ultrasound can help reduce the chances of a lawsuit related to use of the technology.

     

    Reporting and image storage requirements

    Specific guidelines for ultrasound reporting have been propagated by AIUM.24 These guidelines establish the content and timing of an ultrasound report, and represent best practices in ultrasound use. Deviating from the guidelines could place an interpreting physician at risk, particularly if timely reporting of significant findings does not occur.

    Best practices dictate that a formal report, with appropriate image documentation, occur with each examination. Although a note in the patient chart can meet the minimal requirement, a formal written report enhances the credibility of the performing lab or institution, and clarity for the referring physician. Images should be maintained for the applicable statute of limitations for each state or jurisdiction. Retaining images either in an archiving system (PACS system) or in digital format is preferable to thermal prints.

    Informed consent

    Informed consent involves comprehension, or understanding, and voluntary choice.25 Two standards of consent—the reasonable person (patient) and the reasonable physician—vary with each jurisdiction. The reasonable patient standard holds that the communication to the patient is adequate and sufficient enough that a reasonable person could make a reasonable decision based on the provided information. The reasonable physician standard holds that the information communicated to the patient is what a reasonable physician would have discussed with the patient. Informed consent is an interactive discussion and understanding between the patient and physician and the signed consent merely memorializes those discussions.25

    Related: Adolescents, the law, and informed consent

    The elements of ultrasound consent comprise: 1) a discussion of the diagnosis or nature of the condition; 2) the planned procedure; 3) alternatives to the procedure, including doing nothing; and 4) the substantial risks of the ultrasound or procedure. Further, a discussion of potential outcomes if an ultrasound is not done is inherent to adequate informed consent.26 Requirements for written consent for specific ultrasound studies varies regionally, locally, and between institutions. However, a discussion of the limitations of any ultrasound study is integral to appropriate informed consent.

    Obstetrical ultrasound poses several challenges: 1) the inherent inability to visualize all fetal abnormalities or anomalies; 2) the fact that some anomalies evolve during the course of a pregnancy; and 3) the challenges fetal position or maternal body habitus impose in adequately visualizing all required fetal anatomy. Informing the patient of these limitations and documenting such limitations is crucial to mitigating liability. It is advisable that a patient’s body mass index (BMI) be included in all ultrasound reports. This objectively addresses one of the major imaging limitations encountered with increasing frequency. In addition, any limitations in adequately visualizing all required anatomy should be documented in the written report. Guidance for required follow-up when fetal anatomy cannot be completely assessed was issued by a consensus panel on fetal imaging.27 The recommendation is a follow-up examination in 2 to 4 weeks and, if adequate visualization again is not feasible, a comment should be made in the formal report regarding such limitations, with any future studies based on clinical indications. Patients should be advised of the encountered limitations and indications, or lack thereof, for future ultrasound studies.   

     A patient who presents for a gynecologic ultrasound infers consent to the performance of a complete ultrasound procedure. However, documentation of a patient’s express consent is warranted for vaginal ultrasound, particularly with sonohysterography, sonosalpingography, or ultrasound-guided puncture procedures.. A discussion regarding the limits of gynecologic ultrasound, both vaginal and abdominal approaches, is crucial to limiting liability exposure. If the sonologist is acting as a consultant, he or she should inform the patient that her primary physician is responsible for any clinical-care decisions based on the ultrasound findings.

    During any pelvic exam, chaperones are recommended, whether the provider is female or male. Logically, that should also apply to vaginal ultrasound. However, the routine, habit, and custom in most diagnostic units is that female, and occasionally male sonographers, do not routinely have chaperones during sonographic studies. A chaperone is recommended when males perform vaginal, transperineal, or rectal studies. Patients should have the option for a chaperone during all such studies and should consent, either verbally or in writing, to the lack of a chaperone.

    NEXT: Conclusion and references

    James M. Shwayder, MD, JD
    Dr. Shwayder is Professor and Chairman, Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson.

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