Mind the Gap: Legal Liabilities Associated with Bringing Outside Images into PACS
Health policy in the U.S. has made the portability and exchange of electronic patient health data an important priority. The transfer of medical imaging data, however, carries with it some unique considerations and responsibilities.
Radiology Business Journal turned to Thomas Hoffman, JD, CAE, associate general counsel for the American College of Radiology, to explore the potential liabilities associated with bringing outside images into the organization’s PACS. His responses underscore the importance of developing policy and processes around the decision to bring an outside image into PACS.
How would you rate this issue in importance to your membership: Legal liability for medical images from outside the organization that are ingested into the hospital PACS?
Hoffman: This issue matters to ACR members. Although the legal office has not received many calls or emails on it recently, it carries medical-legal weight.
Are there trends that could bring this issue into the forefront of those that need to be managed? For instance, hospital consolidation and cloud-based image sharing services.
Hoffman: Consolidation of hospitals and health systems along with radiology practices combine to raise the stakes of following a sound policy on whether to accept outside images that go into a PACS. For instance, a radiology practice in a hospital, or even at a freestanding imaging center, should assess issues such as how it can vouch for the image quality of an outside image that may go into a PACS. Has an image that comes from an external source been captured with sufficient if not optimal image quality for the radiologist at the receiving site to consider interpreting and reporting?
Commentators such as Dr. Leonard Berlin(1,2,3,4) and others have highlighted these unresolved issues. As radiology in the 21st century becomes ever more state-of-the-art technologically, ACR members still must apply more traditional principles of negligence to determine whether they owe a legal duty to a patient through a potential relationship. If they choose to interpret that image or set of images, what are the consequences?
A fundamental question that ACR members need to resolve is, as the image comes into a PACS, then what? Does it create a physician–patient relationship to attach potential liability onto the radiologist, particularly if he or she has no access to prior studies or reports associated with the patient? This issue, therefore, continues to percolate in radiology circles.
Are there any legal precedents around this issue?
Hoffman: The courts have ruled over the years generally about radiologists (and other physicians who interpret imaging studies) having potential liability for losing images in a PACS. Courts have ruled that radiologists may be liable for failing to maintain proper custody of that study. For example, there’s a case in Illinois courts in which the Illinois Supreme Court ruled that physicians do have a duty to preserve evidence and therefore could be sued for either destroyed or lost evidence.
This also raises a related issue of what is the role of the hospital or health system. Does the hospital or health system have what is known as vicarious liability for the potential negligence of a radiology department or of the hospital’s IT department? In other words, the radiologist may have done everything correctly or may not have had any role at all, but a PACS may receive outside images, and they are not processed correctly or are lost or compromised by a technologist or other staff. Who is to blame there?
I have not found recent precedent on point but believe that courts will have to evaluate, as courts typically do, on a case-by-case basis whether an ACR member would be liable for an outside image coming into PACS. It depends on the particular relationship with an outside facility, the quality of images, and then the radiologists’ actions or omissions once the images come into their realm.
What in general is the position of medical malpractice insurers?
Hoffman: I do not know of a particular position that the insurance industry has taken. Its association of medical professional liability insurance companies, PIAA, may have issued some guidance recently, though.
If this continues to cause considerable questions in radiology circles, that raises a good point about what medical liability insurance coverage, if any, ACR members and practices should have with their insurers. They should contact their malpractice carrier before deciding to accept outside images because that could trigger higher liabilities.
Are there aspects of this issue that leave a practice particularly exposed to lawsuits, such as whether or not the image is overread or making an image a part of the medical record?
Hoffman: The latter part is really what relates to medical jeopardy. That is, if and when an image and a report that is rendered about the image comes into the patient’s medical record, then it is considered an official part, and an ACR member who decides to interpret the outside image then becomes a physician—if not the physician—of record and could have liability because he or she has made a decision that affects patient care.
Are there steps a practice can take to protect themselves from liability? Should these images that patients bring with them from another facility be quarantined?
Hoffman: Yes. Practices have to protect their interests not only as a matter of reducing medical-legal risk but, more importantly, providing optimal patient care at the appropriate time. Those steps should start with deciding whether or not to accept those images.
Develop a sound policy, enforce it, train people on it, have a central point to resolve issues, such as what happens when you get images from a major referral source. These measures will assist ACR members and other radiologists who consider whether to accept, let alone interpret, those studies. Other important issues to address include: what if there is a conflict, a potential discrepancy between a prior image that comes from another site and the report that would be rendered by the radiologist on the receiving end? How do you communicate those discrepancies to the referring physician and even the patient?
Think about and develop answers to those questions. Communicate with one another. Radiology knows that mantra well: Communicate early and often, and document too.
Who should be a part of creating the policy around outside images?
Hoffman: I believe the circle has to include hospital risk management officials, radiology, senior leadership, the department chair, IT representatives even up to CIO or his or her number two, and other clinicians who are also in the mix with outside images and whether or not they should go into the PACS. Everyone has a role to play there. Will those conversations be easy and quick? No, but they have to occur.
References
- L. Berlin. Storing unread radiologic images in a PACS. Am J Roentgen. 2011;196:W100.
- Berlin L. Storing unread radiologic images on PACS. Am J Roentgen. 2012;198:W395.
- Berlin L. Entering unread or outside-read radiologic exams to a PACS. Am J Roentgen. 2012;198:W621.
- Berlin L, SmithJJ. Picture archiving and communications systems (PACS) and the loss of patient examination records. Am J Roentgen. 2001;176:1381-1384.
Vice President, Executive Editor, Radiology Business
Cheryl began her career in journalism when Wite-Out was a relatively new technology. During the past 16 years, she has covered radiology and followed developments in healthcare policy. She holds a BA in History from the University of Delaware and likes nothing better than a good story, well told.