Diagnostic Safety Event Reporting

“Now more than ever, we must all work together to create the safest health care possible.”  [1]

Safety event reporting is an essential component of any healthcare and hospital system’s efforts to improve patient safety by helping to identify trends and prioritize improvements.

Though incident reporting has its origins in other industries, including airline and nuclear power industries, health care has adopted it to improve the delivery of care. In fact, the Institute for Healthcare Improvement released the National Action Plan to Advance Patient Safety, which calls upon organizations to “widely share safety information to promote transparency.”

One tangible example of its value comes from improved notification rates of hospital-associated infections (HAIs), which must be reported to the U.S. Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network. These reports have allowed health systems to adapt their processes and implement patient-safety measures, for which 51 states performed better on at least two infection types in 2019.  [2]

Safety Event Reporting Challenges and Flaws

Safety event reporting is not without its challenges. It relies on user-submitted data, which is subject to bias. For example, a patient perspective may differ from a provider’s perspective, which differs from a chief quality officer’s perspective. These flaws generally mean that incidents are under-reported, which can skew the data. [3]

“In the early stages of implementation, it is important to educate, inform, and get staff to report events.” [4]

Organizational culture plays a big part in the effectiveness and use of safety event reporting. Psychological safety, the belief that you won’t be punished when you make a mistake, is critical to reporting and accountability among teams. [5] If providers feel as if they are going to be punished for submitting a safety event report, they are less likely to submit the report, which limits the robustness of rich data for analysts.

“Lack of psychological safety inhibits team members from speaking up and causes them to opt for avoidance behaviors, such as silence.” [6]

The National Action Plan aims to reduce harm in health care. One of its recommendations is the need for total systems safety—from culture and partnerships to prioritization within the system itself. It calls for organizational leadership to assume accountability for physical and psychological safety and create a healthy work environment. This includes embedding key safety practices into systems, workflows, practices, and care.

Despite its flaws, safety event reporting is an important tool for identifying system hazards and aggregate data, and sharing lessons within and across organizations. Systems can share known fail points in care, which allow other systems to identify that as a potential risk within their own organization. For example, systems can find a failure point in their procedures that lead to more patient falls, which can then be used to target interventions and share their findings broadly to prevent patient falls from happening elsewhere.

Event Reporting in Diagnostic Safety

While safety event reporting has a long history in health care, its use in the diagnostic space has been considerably more limited and disparately utilized across organizations.

The nature of diagnosis and the design of the healthcare system makes the implementation of safety event reporting in diagnosis difficult. A diagnostic journey may take a patient from specialist to specialist and healthcare system to healthcare system, many of whom don’t necessarily have compatible electronic health records (EHR) that can easily transfer data. This can result in wrong or missed diagnoses slipping through the cracks, as well as near misses. Additionally, there isn’t a consistent definition or understanding, or vocabulary for diagnostic safety events, so calling them out in reporting efforts is a challenge.

Despite the complexity of integrating diagnostic processes into safety event reporting, some organizations are leading the way. The Primary-Care Research in Diagnosis Errors (PRIDE) Learning Network is a local and national effort to improve diagnostic safety led by the Brigham and Women’s Center for Patient Safety Research and Practice with funding from the Gordon and Betty More Foundation.

The PRIDE Network allows experts to review de-identified case studies, which are then used in clinician awareness programs to ultimately improve patient care. Anyone can submit a case study using the Network’s form. These case studies are then reviewed and published on the website for anyone to review and can also be used for roundtable case discussions.

“It’s important to begin moving into solutions, while also determining how to capture diagnostic error events. We don't want to spend six months designing the perfect mechanism for identifying events and lose that time in terms of prevention.”  [7]

The case studies are analyzed using four main taxonomies:

  1. Diagnosis Error Evaluation and Research (DEER), which identifies wherein the diagnostic process an error may have occurred;
  2. Reliable Diagnosis Challenges (RDC), which focuses on factors that may have contributed to making diagnosis difficult;
  3. Generic Diagnostic Pitfalls (GDP) categories, which are clinical patterns/vulnerabilities that lead to missed, delayed, or wrong diagnosis; and
  4. Cognitive Errors, in which clinician bias may have contributed to the diagnostic error.


Each case study includes a summary of symptoms and test results, issues with the case, and suggestions to remedy similar problems in the future, such as decision-support tools, processes that streamline consultations and considering the possibility of false negatives.  Results of this program could set the stage for consistent definition, enumeration, and analysis of diagnostic safety events.

The Pennsylvania Patient Safety Authority is another organization leading the way in tracking diagnostic safety events. Using the DEER taxonomy, it reviews events that likely involved diagnostic error or failures in the diagnostic process. One report yielded 1,212 potential incidents, which were then narrowed down to 138 diagnostic process failures. [8] Of those events, more than two-thirds (68.1%) involved failures of the testing process, while monitoring/follow-up accounted for 13.0 percent of all events. This data will be used to measure diagnostic process failures better, recognize patterns, and prioritize areas of opportunity for learning and improvement.

The DEER taxonomy is available on the Patient Safety Authority’s website for stakeholders to download and use along with other diagnostic error tools, such as the Diagnostic Error Measures Worksheet, checklists, and patient education materials.

Common Formats for Event Reporting

The Agency for Healthcare Research and Quality (AHRQ) Common Formats for Event Reporting (CFER) aims to establish standardized definitions and formats to collect, aggregate, and analyze uniform information. [9] CFER is used to report incidents, near misses, or general unsafe conditions. Previous CFER has targeted interventions in nursing homes, community pharmacies, hospitals, and more.

The agency opened Common Formats for Event Reporting – Diagnostic Safety (CFER-DS) for comment in June 2021, which built upon the work conducted by organizations like the Pennsylvania Patient Safety Authority and PRIDE Network. CFER-DS is not a reporting system, but it gives providers a tool for reporting diagnostic safety incidents. CFER-DS can be used within hospital systems, at a state-wide level, or across systems and state lines.

The CFER-DS conceptual model follows an event trajectory, starting with the ‘first diagnostic episode,’ or when the patient engages with the health system for the first time. From there, it measures the certainty of diagnoses, care setting, the information needed that could have led to an accurate diagnosis, contributing factors that led to the inaccurate or delayed diagnosis, and impact on the patient.

The Society to Improve Diagnosis in Medicine (SIDM) solicited feedback on the CFER-DS from members of the Coalition to Improve Diagnosis (Coalition) well as non-Coalition member patient and family groups through stakeholder interviews, meetings, and e-mail exchanges. Their insights were shared with members of the Coalition during a June 22 call.  During the call Gerry Castro, Director of Quality Improvement, reviewed the common formats draft and participants discussed opportunities to improve the draft, noting that the formats need to focus on diagnostic safety reporting—not errors; incorporating other members of the diagnostic team, including nurses, in the reporting structure; the need for the patient voice in both the formats themselves and the reporting; and the need to track disparity and equity data for patients and providers.

SIDM submitted a formal comment and accompanying comment letter on July 1 with 19 organizations from the Coalition to Improve Diagnosis and beyond signing the letter in support. In August, a National Quality Forum expert panel will review comments and develop recommendations in late August/early September.

The Future of Safety Event Reporting

Just as diagnosis is a team sport, the future of diagnostic safety event reporting relies not just on the individuals submitting reports but on leadership to support these efforts. The CFER-DS is only as good as the data collected, and fear of retaliation or punishment may negatively affect these data and the process. Any effort around event reporting needs to include steps to ensure providers feel safe in event reporting, and that can only be achieved through efforts to change the culture within a system.

The CFER-DS, PRIDE, and the Pennsylvania Patient Safety Authorities' work on reporting presents an opportunity for the field of diagnosis to reach a consensus on how to document, investigate, and learn from these events, allowing for practical, scalable solutions, and evolve over time. The short-term goal of these efforts is to create a starting point for an important conversation, which will focus on creating and envisioning the “ideal” system of event reporting and developing a roadmap to build that system. The shared understanding will guide those conversations that for systems to use an event reporting structure, it must be practical, scalable, and flexible. In the end, SIDM hopes to create a consensus approach to event reporting and catalyze, investigation, and shared learning.

Registered nurse wearing a face mask documents medicine provided to a patient into a laptop computer at the nursing station at work, Indiana, USA
In this Issue:
Raising Awareness of Diagnostic Quality and Safety with Policymakers

Read how SIDM members and the Coalition to Improve Diagnosis have been instrumental in bringing the issue of diagnostic safety and quality to policymaker attention, raising awareness, educating them about the scope and scale of the problem, and calling for increased research funding to begin to identify and implement scalable solutions.