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Practice Communication Failure Leads to Delayed Diagnosis of Breast Cancer

June 21, 2017

Misdiagnosed breast cancer is one of the most common claims against radiologists.1 Although much of the onus for ensuring that follow-up occurs is on the referring physician, all providers involved in the patient’s care should establish and then follow policies on communication of radiologic diagnosis and testing. Had communication roles been clear, this patient’s breast cancer could have been discovered earlier and a lawsuit could have been averted.

Allegation

Delayed diagnosis of breast cancer necessitated a radical mastectomy and decreased chance of survival.

Case File

female-gynecologist-looking-at-a-mammogram-socA 41-year-old patient presented to her family practice physician (FP) in April 2014 for an annual physical. Her FP determined she was in good health and gave her an order for a screening mammogram. The patient put off the mammogram until January 2016, when she discovered a lump in her right breast. She went to the hospital radiology department, where a mammogram and sonogram were performed. After the studies were complete, the patient was told her results would be forwarded to her and her FP. The next day, the mammogram and ultrasound were read by a radiologist. He described the mammogram as BI- RADS 4 based on a nodular density in the right breast and reported the ultrasound showed a mass. He strongly recommended biopsy. The radiologist wrote “biopsy” on the mammogram request form and left the notated form in the inbox in the radiologic technologists’ office. It was the radiologist’s understanding that one of the technologists would take care of communicating the results. It was not the radiologist’s practice to contact referring physicians with results unless the results indicated an immediately life-threatening condition.

The next day, a radiologic technologist called the FP’s office and told the FP’s nurse that the radiologist had recommended a biopsy. The nurse believed the radiology office would inform the patient of the results, and that the radiologist’s report would be sent to the FP’s office. The nurse made a note in the patient’s medical record and placed it in the follow-up area; however, it was overlooked.

The radiologist’s electronic health record (EHR) was configured to print a report summary for the patient and a report for the referring physician. The printing of the report was supposed to prompt a staff member to fax the report to the referring physician and mail the summary to the patient. Unfortunately, the name and demographic information for the patient’s FP had not been entered into the hospital’s EHR system. As a result, the patient summary and report were not printed. When the patient did not hear from the radiologist or FP, she assumed her results were negative. Six months later, however, her breast lump began to ache, and she called her FP. After a series of telephone calls, it was discovered that the results had not been communicated. The patient was diagnosed with poorly differentiated ductal carcinoma shortly thereafter. She had a mastectomy and underwent chemotherapy but died the following year. Her family filed a lawsuit against the radiologist, the hospital and her FP, alleging the delay in diagnosis decreased her chance of survival.

Discussion

Guidance on the MQSA

Mammography Policy Guidance Help System. United States Food and Drug Administration. Updated 2/8/2017. (accessed 10/1/2019)

Mammography Accreditation Program Requirements. American College of Radiology (ACR). Revised 12/7/2015. (accessed 10/1/2019)

The national Mammography Quality Standards Act (MQSA) requires radiologists to send a summary of the written mammography report directly to the patient. When the results are suspicious, the radiologist is also directed to communicate the results to the referring physician as soon as possible.3 Although the radiologic technologist’s conversation with the FP’s nurse technically fulfilled this second obligation, it did not prompt a timely biopsy.

The risk of communication failure was further in- creased by the radiology department’s EHR system. It was configured to prompt the mailing of the report to the referring physician first, then to the patient a week later — a policy consistent with American College of Radiology (ACR) recommendations.4 Unfortunately, a glitch in the system prohibited the reports from printing at all, because the referring physician’s name and address had not been entered into the hospital database. When questioned during litigation, staff members in the radiology office admitted they had noticed this problem in the past and even predicted the computer issue would result in patient harm. However, despite the fact that they had sent multiple reports of the problem to the hospital’s information technology department, the issue had not been fixed.

Additionally, during litigation the defense team discovered that each radiologist in the department had his or her own protocols for notifying patients and referring physicians of critical results, and each radiologist’s definition of a “critical” result differed. There were no radiology department communication protocols, and none of the radiologists were aware of the hospital policy for directly communicating critical results to the referring physician. The defendant radiologist’s personal practice of only contacting the referring physician in life-threatening circumstances (a violation of hospital policy and ACR communication guidelines2) made him appear callous and uninformed, which in turn made his defense more difficult. Due to these and other issues, the case settled.

Medical Liability Risk Management Recommendations

Risk Management Recommendations for Radiologists

In general, radiologists should know which findings require immediate reporting to the referring physician, how to notify the physician, who should receive the notification when the ordering physician is not available, how quickly the notification must take place and how to document that the results have been received by a physician who will take action on them.1,2

Consider the following recommendations:1,2,5,6,7,8

  • Be aware of hospital/practice communication policies and protocols.
    • Comply with the protocols when appropriate and work with the administration to make the protocols more effective if necessary.
    • If there are no communication and notification policies, work to create and implement them.
  • Follow clinical guidelines [e.g., the American College of Radiology Practice Parameter for Communication of Diagnostic Imaging Findings] when appropriate.
  • Follow the radiology-result communication laws (e.g., the MQSA).
    • Tell patients to expect a results letter and to contact you if they do not receive it.
  • Document actual or attempted direct communication with the referring physician, a nurse, an associate or a patient, and include the information about communication (or attempted communication) in the diagnostic report.
    • Documentation should include, at a minimum, the name of the person to whom the results were reported, the date and time of the communication and what was discussed.
  • If a finding requires urgent intervention, inform the referring physician by telephone without delay.
  • Have a process in place that will ensure the patient is advised to consult promptly with his or her primary care physician regarding all suspicious findings.
  • Create an environment in which staff and colleagues are supported in their efforts to resolve issues that threaten patient safety.
  • Take an active role in ensuring the appropriate communication of radiology results.

Risk Management Recommendations for Radiology Group Administrators

In many radiology claims, it is unclear which physician has responsibility for follow-up. Closing the gaps in communication and follow-up can make the difference between a missed or delayed diagnosis and a successful intervention or treatment. Consider the following recommendations:5,6,7,9

  • Establish communication policies and protocols that at a minimum include guidance on:
    • How to communicate radiology results to patients (e.g., emergent findings, unexpected findings or findings that require further testing).
      • In person discussion with patients for whom biopsy is recommended can reduce communication deficit risks.
    • How to communicate radiology results to referring physicians.
    • What the time frames are for reporting various types of results.
    • Whom to communicate with in various circumstances (e.g., when the ordering physician is not available or not discernible; when the patient has self-referred; or when the patient has been referred by a third party, such as an employer or insurer).
    • What methods of communication are acceptable (e.g., direct telephone communication, email, etc.).
    • What information needs to be documented.
    • Where the communication information should be documented (e.g., the final report, the patient’s medical record, the department log).
    • Follow-up responsibilities when discrepancies occur in radiology interpretations (e.g., when a primary treating or emergency room physician’s interpretation of a film differs from a radiologist’s subsequent reading).
  • Build patient safety redundancies into radiology result communication protocols.
    • Monitor compliance with protocols and policies, and ensure that any issues are addressed.
    • Monitor the effectiveness of the system.
  • Consider tools (e.g., an EHR program that posts incidental findings to a work list) and protocols to improve the communication of incidental radiology findings.
This content originally appeared as part of the October 2018 release of the NORCAL Group Risk Management publication, Claims Rx, “Breast Cancer - Reducing the Risk of Delayed Diagnosis.” This release and many others are available in the Claims Rx Directory for download. Policyholders will also find instructions for obtaining CME credit for select releases.

References

1. Thomson NB, Patel M. "Radiology Liability Update: Review of Claims, Trends, High-Risk Conditions and Practices, and Tort Reform Alternatives." J Am Coll Radiol. 2012;9:729-733.

2. American College of Radiology. "ACR Practice Parameter for Communication of Diagnostic Imaging Findings." 2014. (accessed 10/1/2019)

3. FOOD AND DRUG ADMINISTRATION. "Mammography Quality Standards; Final Rule." (accessed 10/1/2019)

4. American College of Radiology. "Direct Reporting of Results to Women by Mammography Facilities. (accessed 10/1/2019)

5. Hanna D, et al. "Communicating Critical Test Results: Safe Practice Recommendations." Jt Comm J Qual Patient Saf. 2005;31(2):68-80. (accessed 10/1/2019)

6. Singh, H. and M.S. Vij, "Eight Recommendations for Policies for Communicating Abnormal Test Results." Jt Comm J Qual Patient Saf. 2010;36(5): 226-32.

7. Berlin L. "Failure of Radiologic Communication: An Increasing Cause of Malpractice Litigation and Harm to Patients." Applied Radiology. 2010; 23(1-2):17-23. (accessed 10/1/2019)

8. Laing D, Now L. "A Radiologist’s Duty to Communicate with the Treating Physician." Health Law Litigation. 2010 Winter;8(1):1-6.

9. Daugherty B, Ewton B. "Tracking Incidental Findings." Radiology Today. 2014 Jul;15(7):6. (accessed 10/1/2019)

Filed under: Diagnosis & Testing, Radiology, Oncology, Case Study, Practice Manager, Physician, Practice Communication

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