Diagnostic Challenges: Understanding Contributing Factors to Reduce Risk June 6, 2025 Member Benefits, Practice Management, RCMA, RCMA/CMA, Resources, Risk Management Business Partner, ProAssurance, RCMA, Resources, Risk Management 0 This informative article is provided by ProAssurance Download Article By Kelly Riedl, PA-C, CPHRM Introduction The diagnostic process has been defined as a “complex and collaborative activity that unfolds over time and for most patients occurs within the context of the health care work system.”1 In 2014, the Institute of Medicine appointed an independent committee to define the complexities of this process with the objective of improving diagnostic accuracy amongst clinicians. Their diagnostic process map serves as an important reminder that both patients and clinicians play a role in ensuring diagnostic accuracy. The map contains the following steps:1,2 Patient experiences a health problem Patient engages with health care system Iterative process of information gathering, integration, interpretation, and working diagnosis Communication of the diagnosis Treatment Outcomes Breakdowns occurring at any of these steps may result in a diagnostic error, but this does not necessarily equate to patient harm. The definition of diagnostic error varies, but according to the National Academies of Sciences, Engineering, and Medicine, it is “the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.”2,3 In the primary care setting, studies suggest that there are multiple causes of diagnostic errors but that cognitive errors stemming from mental processing and bias are the most common.4,5,6,7 Cognitive Bias Contributes to Delayed Diagnosis Communication is a vital element of patient care and can impact both patient compliance and medical professional liability risk when breakdowns occur. Common themes observed in malpractice claims include physicians failing to adequately educate or warn patients on the importance of a test, and patients failing to listen or comply with the recommended test. A study investigating lessons learned from diagnostic errors in primary care found that “[t]he most common pathway leading to error … was the assignment of common benign diagnoses to patients with uncommon serious diseases.”4 Consider this concept as the details of this case study unfold. December 12, 2013—A 35-year-old patient with a history of irritable bowel syndrome, acid reflux, obesity, recurrent ear infections, and multiple ear surgeries in childhood presented to his family medicine clinic with a complaint of ear pain and shortness of breath on exertion. An EKG and urinalysis were obtained and were both normal. He was prescribed azithromycin and instructed to return in the morning for fasting blood work. A Hemoccult test kit was provided along with instructions to return the card in three days. The patient’s lab results revealed anemia, and additional testing revealed iron deficiency. He was prescribed iron and told to follow up in one month for repeat labs. May 6, 2014—The patient presented for follow-up regarding the iron deficiency anemia and for refills of omeprazole. Repeat labs were drawn to evaluate the anemia, and these labs revealed continued iron deficiency. The results were relayed to the patient over the phone. He was instructed to continue the iron replacement and return the Hemoccult cards. Four days later the patient returned one of three Hemoccult cards, and this was negative. December 12, 2014—The patient presented with complaints of worsening anxiety and depression and for refills of omeprazole. At this visit he explained he was having difficulty sleeping, had lost his appetite, and had no energy. He was noted to have lost 25 pounds unintentionally over the past three months. The patient was started on antidepressants and referred to a mental health counselor. He was also reminded to return the Hemoccult cards. Labs were drawn and revealed continued iron deficiency anemia. The patient was advised to increase his iron supplementation and was referred to a gastroenterologist (GI) for possible endoscopy. January 21, 2015—The patient presented with complaints of vomiting, abdominal pain, and constipation. He explained he had not yet seen a GI but had an appointment coming up in February. A one-view abdominal x-ray was ordered and was negative. The patient was prescribed sucralfate and simethicone and advised to follow up with a GI as planned. February 4, 2015—The patient presented to the ED with worsening nausea, vomiting, and constipation. A CT scan of the abdomen and pelvis was obtained and revealed a 6.3 cm constricting lesion in the ascending colon in the region of the hepatic flexure, with adjacent enlarged lymph nodes. He underwent an EGD and colonoscopy three days later which revealed a short segment of Barrett’s esophagus, hiatal hernia, and a mass in the right colon at the hepatic flexure. February 8, 2015—The patient underwent a right hemicolectomy with reanastomosis. He was ultimately diagnosed with stage IVB adenocarcinoma of the sigmoid colon and given a poor prognosis. The patient and his wife originally filed a medical malpractice and loss of consortium claim, but while the case was pending the patient passed away. The medical malpractice claims were subsequently converted to wrongful death and survival claims. Discussion Experts agreed that the standard of care may have been breached by failure to refer this young, otherwise healthy male, with no overt signs of bleeding, to a GI specialist sooner. They agreed this likely caused a delay in the diagnosis of cancer. Additionally, experts commented that the patient’s underlying comorbidities and age made this a more difficult diagnosis. What complicated the defensibility of this case were patient survey records brought forth by plaintiff’s counsel during discovery. These suggested that the practice could not keep up with the number of patients seen daily. The survey records also suggested that patients were frustrated with follow-up practices that did not keep patients assigned to their previous clinician for continuity. For these reasons, the case was ultimately settled. Risk Reduction Strategies Consider the following risk reduction strategies to help improve patient compliance: Make sure your practice or organization has a reliable procedure to track patients with pending tests or referrals. Educate patients about ordered tests and consults including why these are important, how the results will likely affect further care, and the possible consequences of noncompliance. Always document patient education about tests and consultations. If a patient declines to comply with an ordered test or treatment, discuss and document that you advised the patient of the risks involved in refusing treatment. Note the patient’s rationale for their decision. Consider having the patient sign a refusal of treatment form, and provide a copy to the patient. Consider the following risk reduction strategies to help improve diagnostic accuracy:8 Acknowledge that the diagnostic process inherently involves uncertainty, and share this with patients. Create “diagnostic safety nets” to aid in missed diagnosis prevention. Examples include alerting patients of red flag symptoms to be aware of, when and where to seek help for worsening symptoms, and expectations for the suspected course of their illness. Plan to rule out the “do-not-miss” diagnoses, regardless of how unlikely they may be. Endnotes “The Diagnostic Process,” Society to Improve Diagnosis in Medicine, accessed April 29,2024, https://www.improvediagnosis.org/processes/the-diagnostic-process/. Erin P. Balogh, Bryan T. Miller, and John R. Ball, eds, Improving Diagnosis in Health Care (Washington, DC: The National Academies Press, 2015), https://doi.org/10.17226/21794. “What is Diagnostic Error?” Society to Improve Diagnosis in Medicine, accessed April 29, 2024, https://www.improvediagnosis.org/what-is-diagnostic-error/. John W. Ely, Lauris C. Kaldjian, and Donna M. D'Alessandro, “Diagnostic Errors in Primary Care: Lessons Learned,” Journal of the American Board of Family Medicine 25, no. 1 (January 2012): 87-97, https://doi.org/10.3122/jabfm.2012.01.110174. John W. Ely and Mark L. Graber, “Preventing Diagnostic Errors in Primary Care,” American Family Physician 94, no.6 (2016):426-32, https://www.aafp.org/pubs/afp/issues/2016/0915/p426.html. Satid Thammasitboon and William B. Cutrer, “Diagnostic Decision-Making and Strategies to Improve Diagnosis,” Current Problems in Pediatric Adolescent Health Care 43, no. 9 (October 2013): 232-41, https://doi.org/10.1016/j.cppeds.2013.07.003. Olga Kostopoulou, Brendan C. Delaney, and Craig W. Munro, “Diagnostic Difficulty and Error in Primary Care—A Systematic Review,” Family Practice 25, no. 6 (December 2008): 400-413, https://doi.org/10.1093/fampra/cmn071. Ashley N.D. Meyer et al., “Patient and Clinician Experiences of Uncertainty in the Diagnostic Process: Current Understanding and Future Directions,” Patient Education and Counseling 104, no. 11 (November 2021): 2606-2615, https://doi.org/10.1016/j.pec.2021.07.028. The information provided in this article offers risk management strategies and resource links. Guidance and recommendations contained in this article are not intended to determine the standard of care but are provided as risk management advice only. The ultimate judgment regarding the propriety of any method of care must be made by the healthcare professional. The information does not constitute a legal opinion, nor is it a substitute for legal advice. Legal inquiries about this topic should be directed to an attorney. 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