In defining the top patient safety issues identified in our radiology claims data, we applied the Pareto Principle. It reminds us to focus on the 20% of processes that make up 80% of unanticipated outcomes or errors. The 20% of processes in radiology claims includes interpretation, communication, clinical systems, and documentation.

As the national literature and our claims data indicate, failure or delay in diagnosing, especially breast cancer, is the most frequent allegation in radiology malpractice claims. In analyzing the data, it is important to acknowledge the debate about the degree to which the role of hindsight bias plays in the review of a new radiology test identifying cancer when compared with a previous test interpreted as normal. In addition, the benefits, expectations and limitations of certain radiology tests, such as screening mammography, are controversial within the medical community and general public. These issues notwithstanding, certain aspects of interpretation, communication, clinical systems, and documentation are the areas within your control that can have the most impact on patient safety and risk.

Interpretation

When allegations of failure to diagnose occur, there is often a failure to identify the need for appropriate additional diagnostic modalities or procedures in accordance with recognized practice guidelines. It is important to document and communicate to the ordering physician your recommendation for follow-up with other diagnostic modalities or procedures to resolve an actual or potential abnormality. Inform the patient as well and make sure documentation reflects this communication.

New technology, while never a substitute for your medical acumen, has the potential for significant improvements in patient safety in diagnosis. Computer Assisted Detection (CAD) has the capability of marking conspicuous structures & sections to aid in reading images by alerting radiologists to algorithm-based abnormalities in the images. Advantages of this technology are that over time it improves interpretation skills as well as provides for a problem-oriented approach to diagnosis. However, with the recent use of digital capabilities and its ability to manipulate images to aid diagnosis, some speculate that more lawsuits will arise since conspicuity of abnormality can be enhanced. Since there are an infinite number of views available with this technology, and there are no professional standards or guidelines addressing a set of “standard” views a radiologist should look at, it could be alleged that a radiologist was negligent for not viewing that one view in particular that reveals an abnormality. Consequently, conventional legal thinking about medical images and how they might apply in a lawsuit will change. ^[1]

Communication

Communication is an active process which includes obtaining information from and sharing information with the referring physician. Inadequacy of pertinent clinical information on the test request can compromise the diagnostic interpretation. Vague reasons for a study written by the referring physician on a prescription and reliance on patients being fully informed and/or recalling the reason for the exam is unsafe. Enhance the information you receive from referring physicians by utilizing a standardized request form that you make available to all area practices. Be sure to identify whether certain specialties and tests, such as an obstetrical ultrasound, may require a designated request form. Be sure to include a space for the physician to document the specific reason for testing and any significant patient complaints or physical findings. In the case of a request for mammography, critical information such as a history of a breast lump as well as description of the location of that lump should be included on the form.

Inadequate or lack of communication with the referring physician of non-routine significant abnormal or unexpected incidental findings that either pose a threat to a patient’s life or may affect the patient’s health is one of the greatest problems facing radiologists. If there is no referring physician or the referring physician is unavailable, the duty to inform the patient may shift to the radiologist. This is the one area in which you can have the most impact in improving patient safety and risk. While not an official American College of Radiology (ACR) guideline, the process of communicating such information should be in-person or by telephone. Document all communications as to date, time, the name of the physician spoken to, and what was said. A survey of insured radiologists indicate that a large percentage do not fax/send report via certified mail in critical situations when they cannot reach the ordering physician or self-referred patient by phone. It is critical to implement such a process at your practice. The ACR guidelines specify alternative forms of communication, such as text pager, facsimile, voice messaging, including a system that explicitly requests confirmation of receipt of the report by the clinician. Radiologists using Picture Archiving & Computer System (PACS) in all or part of their practice should develop and implement quality control mechanisms to ensure that all examinations performed are successfully transmitted to the PACS network, examinations are interpreted and reports are generated in a timely fashion.