Ultrasound has revolutionized the care of women with obstetrical and gynecologic disorders. It offers critical diagnostic information in a cost-effective, efficient manner, with availability in virtually every ob/gyn office in the country. It has assumed the position as the first-line approach to evaluating pregnancies, as well as many common gynecologic disorders.1 However, the quality of the equipment, personnel training, and even the education and experience of the interpreting physician is quite variable. Thus, study quality is not universally excellent. As a result, errors in diagnosis and interpretation can occur. This article addresses common errors that lead to litigation involving ob/gyn ultrasound, with options to reduce ultrasound-related litigation.
Malpractice: A definition
Malpractice is a tort that requires proof of 4 basic elements: 1) the provider had a duty to care for the patient; 2) a breach of that duty occurred, i.e. a breach of the standard of care; 3) harm directly resulted from that breach; and 4) the harm produced compensable damages. In a liability action, failure to prove every element causes the action to fail. Medical litigation is a civil action. Thus, the burden of proof required to prove each element is the preponderance of the evidence (something > 50%), e.g. more probable than not, which is less stringent than criminal litigation, which is beyond a reasonable doubt. Litigation related to ultrasound focuses on inadequate image acquisition, errors in interpretation or reporting, and lack of obtaining an imaging study.
Inadequate image acquisition
Litigation in this area encompasses all aspects of obtaining suitable images. This includes: 1) inadequate training of the sonographer or sonologist performing the ultrasound study; 2) an inadequate or incomplete study, with images lacking sufficient quality to make an appropriate diagnosis; 3) inadequate supervision of the sonographer; and 4) inadequate maintenance of imaging equipment. Standards have been established for the performance of quality ultrasound studies. Such standards must be met for a practice to achieve accreditation. Such accreditation establishes compliance with accepted “best practices” and may enhance defensibility in the event of a lawsuit.2
Training of personnel performing ultrasound examinations
Sonographers undergo extensive training, testing, and certification to learn proper study performance and image acquisition. The Joint Commission requires that all sonographers employed in a hospital-based environment be certified or eligible for certification by an organization accredited by the National Commission of Certifying Agencies or the American National Standards Institute – International Organization for Standardization. Accredited organizations include the American Registry for Diagnostic Medical Sonography (Registered Diagnostic Medical Sonographer) and the American Registry of Radiologic Technologists. Although learning ultrasound on the job with no formal certification was common in the past, the practice has essentially been replaced by formal, more rigorous training.3