Effective Risk Management Guidelines for Ultrasonograms

Executive Summary

Although ultrasonograms (USG) have become more common for each trimester of pregnancy, only medically indicated imaging should be performed. Physicians face liability regarding failure to diagnose fetal anomalies, so it is important to conduct limited or specialized examination only when necessary and only after a complete examination has taken place.

Recommended Actions

• Document all USG exams and interpretations, including images of appropriate areas and variations from normal size accompanied by measurements.
• When faced with technical limitations during a second or third trimester anatomic evaluation, document the nature of the limitation in the report and consider requesting a follow-up examination.
• Conduct a limited exam only when a specific question requires investigation.

As multiple USGs during pregnancy become more common, there is an increased need for proper oversight, an understanding of requirements and the implementation of effective risk management guidelines.

USGs can be performed by a physician or a physician-supervised ultrasonographer. Physicians are responsible for the quality and accuracy of all exams done in their name regardless of whether they personally produced the images. Though different types of providers may be qualified to perform these exams, it is important to remember that they are all held to the same standard. The American Institute of Ultrasound in Medicine (AIUM), the American College of Obstetrics and Gynecology (ACOG) and the American College of Radiology (ACR) collaborated to develop guidelines for the performance of USGs during pregnancy. In addition, the following classification system was established:

1. First Trimester Exams (before 14 weeks gestation)

There are multiple indicators for first trimester scans, but there are essential elements that should always be included. For patients wanting an assessment of their individual risks of fetal aneuploidy, a standardized measurement of the nuchal translucency should be used with biochemical markers to assess that risk. It is important that practitioners who provide this service use established guidelines and have a quality assessment in place to ensure accurate results.

2. Standard Second or Third Trimester Exams (after 14 weeks gestation)

In addition to biometrics and presentation fetal number, it is important to do a fetal anatomic survey. This can be adequately assessed after approximately 18 weeks gestation. A second or third trimester scan may pose technical limitations for an anatomic evaluation because of imaging artifacts from acoustic shadowing. When this occurs, the report of the sonographic examination should document the nature of this technical limitation. A follow-up examination may be helpful.

3. Limited Exams

A limited exam does not replace a standard exam and is performed when a specific question requires investigation. For example, it could be performed to confirm fetal heart activity in a bleeding patient or to verify fetal presentation in a laboring patient. In most cases, limited exams are appropriate only when a prior complete exam is on record.

4. Specialized Exams

A detailed anatomic exam is performed when an anomaly is suspected on the basis of history, biochemical abnormalities or the results of either the limited or standard scan. Other specialized exams might include fetal Doppler sonography, biophysical profile, a fetal echocardiogram, or additional biometric measurements.

Nonmedical Use of USGs

ACOG and other medical organizations advocate the responsible use of diagnostic ultrasound. ACOG Committee Opinion endorses the AIUM Prudent Use Official Statement, “The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice.” In addition, ACOG Committee Opinion also states, “Nonmedical ultrasonography may falsely reassure women.”    

Liability Issues

We are seeing an increase in claims related to the alleged failure to diagnose fetal anomalies during a second or third trimester USG. While considerable controversy exists with regard to routine ultrasonography in detecting fetal anomalies in low-risk women, there are a variety of things that one can do to improve defensibility should this claim arise:

1. Patients should be counseled as to the limitations of ultrasonography. This should include a discussion as to the sensitivity of the exam for the detection of abnormalities and the potential for false-positive findings.
2. Adequate documentation is essential for high-quality patient care. There should be a permanent record of the USG exam and its interpretation. Images of all appropriate areas (both normal and abnormal) should be recorded. Variations from normal size should be accompanied by measurements. Images should be labeled with the patient identification, facility identification, examination date and side (right or left) of the anatomic site imaged. An official interpretation (final report) of the ultrasound findings should be included in the patient’s medical record.
3. When doing a USG exam, it is important to allow enough time to perform it properly. Beware of the patient that brings her family and wants to have a “20-week” USG at a nonscheduled time.
4. There are often times that technical issues can make it difficult to complete the anatomic survey. If this is the case, it should be documented and may be prudent to have the patient return for a follow-up scan to complete the anatomic survey.
5. It is important to be sure that billing is consistent with the care provided. If the billing is for a standard second trimester exam and only a limited exam was done it can be difficult to defend a failure to diagnose claim.

Be sure that you are aware of and able to perform the essential elements for a given USG type. If you are unable to get a complete anatomic survey, consider bringing the patient back for a follow-up scan. Allow adequate time for the USG and document it thoroughly. Perform only medically indicated USGs and refer patients to a specialist when warranted.

Lessons Learned

• If your practice provides patients an assessment of their risks for fetal aneuploidy, utilize established guidelines for standardized measurements of the nuchal translucency with biochemical markers.
• Consider assembling a list of referrals to specialists to provide patients when warranted.
• Cross-reference medical records before billing patients to confirm that they are being properly charged for the ultrasound examination that was provided.

Potential Damages

Failure to diagnose fetal anomalies in a timely fashion can lead to severe delivery complications or health conditions for both the mother and the child. Claims related to the alleged failure to diagnose fetal anomalies during a second or third trimester USG have risen with the increased frequency of USGs throughout pregnancy. Additionally, failing to perform ultrasound studies when clinically recommended also runs the risk of litigation for providing negligent care.