Asking Patients to Close the Loop on Diagnostic Imaging Test Results
By Susan Carr | Senior Writer, ImproveDx
This article is the second part of a two-part feature on Act 112. Catch up on the first part in the March 2019 issue of ImproveDx.
To prevent missed and delayed diagnoses, the state of Pennsylvania requires imaging providers to directly notify patients when an unexpected test result, though not an emergency, warrants being reviewed by a physician.
Patient notification is one way to keep diagnostic test results from falling between the cracks, especially when unexpected findings indicate a new health problem, but it is arguably a workaround for a persistent patient safety problem. Pennsylvania’s Patient Test Result Information Act, or Act 1122, which went into effect in December 2018, is arguably just such a workaround.
Act 112 was inspired by stories of patient harm due to lost test results and delayed diagnosis. It requires patients be notified within 20 days following certain imaging exams if an abnormal finding indicates they should seek medical advice within 90 days. Organizations in Pennsylvania, including the medical society and hospital association, are working to clarify what the law requires. Meanwhile, a program at Penn State Health’s Milton S. Hershey Medical Center illustrates the challenges and benefits of direct patient notification.
Backstops and Homing Pigeons
Patients may find it hard to understand why radiologists, in command of medicine’s most amazing technologies, can’t reliably deliver simple communications.1 In fact, patients are sometimes used to solve the problem by providing an alternate channel or acting as a backstop for physician-to-physician communication.
Partnering with patients to close this communication gap is not a new idea.3,4 Direct communication with patients offers benefits but will not simplify an inherently complicated process. Learning about a possible new health problem will motivate some but not all patients to see a physician. Some clinicians worry about patients discovering they may have a serious medical problem without an explanation or support from a knowledgeable provider. Patients often don’t understand the radiologist’s role or the relationships among the clinicians involved. Abnormal findings come with different levels of certainty and concern. It may be difficult for any of the players involved to communicate across different provider networks. Last but not least, growth in the number of diagnostic tests means that primary care physicians, among others, receive more messages, alerts, and results than they can manage.
In emergency medicine, there may be neither a referring nor known primary care physician to receive notice about the incidental finding. The patient or a family member may be the only person available to receive the report and recommendation to seek follow-up. Michael Bruno, MD, who practices radiology in a large academic department in Pennsylvania, reflects on situations where there is no physician to whom the ED can send the incidental results. Bruno says we act effectively as if these patients were “homing pigeons,” entrusted with delivering vital information that otherwise lacks a carrier.5
Communication is especially unreliable for results of outpatient diagnostic imaging exams that fall somewhere between critical and expected. Although there is no guarantee that a critical finding will be acted on immediately, results that indicate a potential problem, different from what was expected, are particularly prone to falling between the cracks.
Documentation Does Not Equal Communication
In a simpler time, sending a report to the ordering physician satisfied the radiologist’s duty. Case law and analysis of recent malpractice claims show that is no longer enough. Transmission of a final report may fulfill the standard of care, but radiologists are now held responsible for knowing that communication has been received and had the desired effect, i.e., for closing the loop.4,6
In a 2005 revision of Practice Guidelines for Communications, the American College of Radiology (ACR) introduced the term “non-routine communications,” to acknowledge that some situations fall outside predictable or traditional parameters. The current guidelines, revised in 2014, say the final report represents “definitive documentation” of the study results, not necessarily the definitive means of communicating those results.1,7(p3) Under “non-routine communications,” the guidelines describe situations that warrant further action, proper documentation of non-routine transmission, and recommended methods for alerting the treating or ordering physician of concerning results. The ACR states that, “in certain situations [i.e., self-referred or third-party-referred patients], the interpreting physician may feel it is appropriate to communicate the findings directly to the patient.”7(p6)
The process of communicating imaging results offers many opportunities for failure: Was the report or alert received by the intended physician? That receipt was documented doesn't necessarily mean the report was read. Knowing that the report has been read doesn’t guarantee that the patient will know the results or receive further examination or care.
Make No Assumptions
Timothy Mosher, MD, chair of radiology at Penn State Health’s Milton S. Hershey Medical Center, thinks that engaging patients in the process of test results and diagnosis in general will help. “Often, patients assume the lack of communication is an affirmation that there’s nothing wrong. There’s an education component to this.”
Physicians, too, sometimes mistakenly assume the reporting process and alert systems are reliable. Mosher says, “There’s an overreliance on the system. Patients may think no news is good news. Radiologists may think their report was received and read." Paraphrasing a classic quotation, Mosher points out, “The biggest problem in communication is assuming that it actually occurred.”
Each health system in Pennsylvania will have to figure out how best to comply with Act 112, and each one will face challenges from its own perspective. Mosher’s Hershey Medical Center already has experience with an innovative program designed to ensure proper follow up of unexpected findings. Hershey’s radiology department still views Act 112 as challenging to implement, but the infrastructure it has in place gives it a leg up and may be helpful to other systems as they plan for Act 112.
Failsafe
Hershey Medical Center’s approach to reliable communication of incidental findings, “Failsafe,” uses significant information technology (IT) and human resources to ensure that patients receive follow-up care. Although now a large program used in all departments that offer imaging at Hershey Medical Center, Failsafe is finely tuned to solve a specific problem efficiently.
Radiologist Michael Bruno (of the earlier homing pigeon metaphor) wanted to improve communication about incidental findings for patients in the emergency department. He knew patients were often lost to follow-up for various reasons, including the reality that ED patients are focused on immediate needs and may not fully understand that a different health problem needs attention. The incidental finding should go to the patient’s primary care physician (PCP), for follow-up. In Bruno’s experience, many ED patients can’t provide the name of their PCP, don’t have one, or have more urgent things to think about.
Working with a team of emergency physicians, PCPs, department chairs, the chief quality and medical officers, plus an attorney, Bruno created Failsafe, which was first implemented in 2012. Initially, patients with incidental findings that warranted follow up but were not urgent enough to have been addressed in the ED received a letter instructing them to see a primary care physician. PCPs at Hershey pledged to see patients who did not have their own PCP. After the department had issued approximately 500 Failsafe letters, Bruno called a sampling of patients to ask for feedback and learned that the program had been ineffective, due largely to misunderstanding. Among the patients he was able to reach, some had ignored the advice to seek care and others had discarded the letter, assuming it was irrelevant or a bill.8
Adding personal contact by telephone transformed the program. Nicole Seger Swope, RN, manager of patient safety at Hershey, joined Failsafe in 2016 and began following up letters with personal phone calls to patients. Swope and Megan Rudy, who joined Failsafe in 2018, call patients to make sure they understand the letter and to encourage them to make an appointment to see a PCP. The letter includes a pre-populated release form to make it easy for patients to consent to have their health information sent to the PCP. Including the consent form does more than facilitate the process. Swope believes it provides visibility—a surprise benefit—and catches patients’ attention. She says, “The yellow ‘sign here’ flag distinguishes our letter from others patients get from Hershey—bills, for example.”
Contacting patients by phone provides other benefits: information, feedback, and relationship-building. Swope reports that very few patients among the hundreds she and Rudy have called report having been made anxious by the letter. They have been able to update contact information for patients, field complaints, triage immediate care needs, and connect patients to scheduling services. The calls are scripted and a number of the situations they encounter—insurance questions, for example—have an algorithm for efficient response. Failsafe is not limited to one call. Swope and Rudy will call patients again to see if the they have seen a PCP and to learn if the diagnosis changed and how things turned out.
During each call, the nurses enter data and notes directly into an electronic system. Failsafe’s IT component is handled through Hershey’s safety-event reporting system. With programming provided by Andy Moyer, RN-BC, BSN, a clinical informatics specialist in Hershey’s patient safety department, customizable modules in the system enable data acquisition and reporting, as well as automation of many parts of the process. When the system prompts the nurses that it’s time to call a patient, they have the information they need and are confident that the call is necessary.
Preparing for Act 112
Hershey’s work on Failsafe has provided some degree of readiness for Act 112, but the new law requires new systems to be developed and poses questions that will take some time to answer. Bruno reports, “Failsafe doesn't satisfy everything in the law, so we had to set up a parallel process.”
As information services director for medical image management at Hershey, Jonelle Thomas, MD, works with a team to develop systems for both Failsafe and Act 112. Thomas is also involved in Failsafe daily. She helps to determine, for example, if patients have received follow-up care between the time they were entered in the Failsafe system and when the letters are mailed, which can be as much as one week later.
Thomas and a team that includes IT, radiology, cardiology, and obstetrics meet frequently to work on Act 112 implementation. With the first Act 112 letters expected to be mailed in May, this is still a new program. Some of the processes Hershey has in place for Act 112 provide a good start but may be replaced with more sophisticated approaches as time goes on. Thomas reports having looked into using natural processing to help sort Failsafe and Act 112 into separate worklists but found the cost was prohibitive for the moment.
Thomas sees value in patient engagement efforts such as Act 112:
It’s important to encourage patients to take an active role in their care. This gives them that engagement in radiology. A lot of patients didn’t really know that radiologists are physicians. Radiology has been kind of a black hole to them.
Although Failsafe and Act 112 both address incidental findings by directly notifying patients, the two approaches are distinctly different. Act 112 is triggered by exam type. Failsafe is triggered by a radiologist’s judgment. Act 112 requires an audit to demonstrate an organization has complied with the law. Failsafe is controlled by Hershey, goes above and beyond the standard of care, and does not require external validation. Act 112 excludes imaging provided in the ED. Failsafe’s origins are in the ED and in Bruno’s awareness that ED patients are especially prone to missing out on follow-up. Patients whose incidental findings are captured by Act 112 receive a letter with more detail (ordering provider, date of exam, etc.) than Failsafe patients, but they will miss out on the personal attention of a nurse who calls them at home. That is the most obvious and perhaps consequential difference between the two programs at Hershey.
Mosher and others at Hershey know from experience that Act 112’s letter to patients will help close the communication loop but, in some cases, it still won’t be enough. Looking to future improvement, Mosher says, “We recognize we must go beyond simple notification. We’re going to comply with the law, but we want to go the next step longer term.”
Another important difference is that Act 112 is new, requiring hospitals across Pennsylvania to develop new processes, workflows, and data-tracking systems. The original wording of the law has led to uncertainty and confusion. Failsafe is a mature program that has a track record and history of having learned from earlier implementation. Over the next few years, imaging providers will learn how best to implement Act 112, and some number of Pennsylvania citizens will receive important follow-up care and diagnoses they might otherwise have missed.
Thank you to our reviewers:Mark L. Graber, MD, FACP and Lorri Zipperer, MA.
Thank you to our sources: Michael A. Bruno, MD; Timothy J. Mosher, MD; Nicole Seger Swope, RN; Jonelle Thomas, MD; and Divvy K. Upadhyay, MD, MPH.
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