Preventing delayed diagnoses of cancer continues to be a challenge. To illustrate, this case highlights the lack of systems to close the loop on abnormal test results. A 53-year-old woman presented to the internal medicine clinic for follow-up after being evaluated in the Emergency Department for complaints of shortness of breath and atypical chest pain. Her medical history was significant for smoking, substance use disorder, and a prior breast lumpectomy (benign). At this time, she had a chief complaint of fatigue for several months.
The patient was evaluated by an Internal Medicine resident. Blood work, a stress test, and a mammogram were ordered under the Internal Medicine resident’s name, with no notation of responsible attending physician. The mammogram revealed fine calcifications in the patient’s left breast and a suspicious, irregular mass in her right breast.
The anatomic pathology reporting system in the hospital where the biopsy was performed was manual and not linked to the EHR. The radiologist sent the final report to the Internal Medicine resident via electronic mail, and a hard copy via interoffice mail. The Internal Medicine resident saw the email but forgot to follow up with the patient.
The attending Internal Medicine physician remained unaware of this patient. Fifteen months later, after the completion of his residency, the Internal Medicine resident found the hard copy of the breast biopsy and pathology report while cleaning out his mailbox and notified the patient’s attending IM physician.
By the time patient had surgery within a month of the resident’s discovery, the breast mass had tripled. Surgical pathology from mastectomy revealed a diagnosis of invasive ductal carcinoma and sentinel node involvement. The medical professional liability insurer settled the case.
Lack of Systems Hobbles Abnormal Test Result Follow-up
This lack of systems to support closed-loop follow-up on abnormal test results is a pervasive and challenging problem in our healthcare systems. In a 2014 benchmarking report from CRICO, which is the insurance program providing coverage to all Harvard medical institutions and their affiliates, examining 23,527 malpractice claims filed between 2008 and 2013, 20% were related to a failure in the diagnostic process and 57% were in ambulatory settings. Of those, 45% were related to missed or delayed cancer diagnoses with breast, lung, and colorectal cancer dominating this category.
Diving into the diagnostic processes, almost half of the cases involved inadequate follow-up and poor coordination of care following the testing processes. In fact, in a recent 2019 collaborative study between CRICO and Johns Hopkins that analyzed the proportion of high-injury-severity malpractice cases related to diagnosis-related allegations, missed cancer diagnoses were the most significant vulnerability, responsible for 38% of claims. These diagnostic errors reflect failures to close the loop on diagnostic tests, referrals, and symptoms.
More specifically, these delays may result from tests and referrals not being completed and/or results of these tests not being communicated effectively with patients or to their primary care clinicians. This study analyzed 11,592 diagnostic error cases from Candello, a database representing one-third of all open and closed malpractice claims in the US. Lung, breast, colorectal, prostate, and melanoma were the most common cancers associated with missed follow-up.
Ambulatory Safety Nets Provide Reliable Back-up Systems
Ambulatory safety nets (ASN) are effective interventions to prevent these diagnostic delays. Ambulatory safety nets are person-centered programs that provide a highly reliable backup system for following up on abnormal test results when the standard follow-up process fails. They include the development of registries and reports for patients with abnormal test results, standardized workflows, and the support of patient navigators responsible for contacting patients.
First developed at Kaiser Permanente in 2009, ambulatory safety nets consisted of 24 distinct electronic clinical surveillance programs that were launched to scan for abnormal test results and medication interactions. Now called the Kaiser SureNet program, a recent paper described the experience of using the ambulatory safety net approach for patients with colorectal cancer. From 2014-2019, the SureNet program identified and closed the loop with 1,430 patients with rectal bleeding needing a colonoscopy. Among this group, 7.5% had advanced cancer and 34% had findings that required more frequent colonoscopy follow-up.
Within our community, CRICO began funding several pilots among our insured institutions to create and test the efficacy of ambulatory safety nets. These pilots included ambulatory safety nets for colorectal and lung cancer at a large academic tertiary-care health center with 747 beds, 174 ambulatory practices, and 1.8 million annual visits. The pilot demonstrated the ability to develop effective ASNs to close the loop on abnormal test results in patients requiring follow-up for suspected lung and colorectal cancer.
In 2021, CRICO completed several return-on-investment analyses and concluded that benefits of implementing ambulatory safety nets far outweigh the costs and increase the capability to reduce healthcare disparities. CRICO then offered funding to all 35 member institutions to support the creation of ambulatory safety nets to reduce gaps in the timely diagnosis of breast, colorectal, prostate, and lung cancer attributed to missed opportunities to follow up with patients with symptoms or complaints, including the appropriate communication of test results, consultation assessments, and follow-up care plans.
Ambulatory Safety Net Implementation Frameworks Created
That same year, in collaboration with Ariadne Labs CRICO created an Implementation Adoption Framework to guide our implementation processes with our participating institutions. The first ambulatory safety net guideline that participating organizations completed was the Colorectal Cancer Guideline. All participating institutions have implemented ambulatory safety nets, at least in pilot versions in 2022.
In 2023, we will begin the expansion of the ambulatory safety nets to include patients with suspected breast, lung, or prostate cancer with the intention of full implementation with all four cancer ambulatory safety nets by 2025. One of the great benefits of these CRICO-funded ambulatory safety nets is that we have created a learning collaborative across all participating institutions for sharing best practices and assisting each other with the best approaches toward common challenges.
We look forward to seeing the results as captured by the percentages of patients for whom we can close the loop, the numbers of avoided missed and delayed cancer diagnoses, and in the final analysis, a reduction in associated MPL claims related to missed and delayed cancers. Our ultimate goal aligns with the CRICO mission of protecting providers and promoting safety.