August 13, 2025
3 min read
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It is estimated that at least 12 million people in the United States are affected by diagnostic errors each year, with potentially one-third being harmed, according to the Johns Hopkins Armstrong Institute for Patient Safety and Quality.
A study by Newman-Toker and colleagues estimated that about 800,000 people in the U.S. become permanently disabled or die annually due to misdiagnosis of vascular diseases, infections and cancer.
Data derived from CDC.
The CDC recently published the Core Elements of Hospital Diagnostic Excellence, which is the practice of optimizing diagnostic processes, such as ensuring that test result interpretations are accurate and communicating with patients in a timely manner to improve outcomes. The effort resembles past “Core Elements” documents addressing antimicrobial stewardship and sepsis.
The Core Elements of Hospital Diagnostic Excellence address three components that make up diagnostic excellence: decreasing unnecessary tests and overdiagnosis, fostering diagnostic stewardship, and preventing missed, delayed or incorrect diagnoses.
Core elements
These are the six core elements of hospital diagnostic excellence, according to the CDC:
1) Hospital leadership commitment and accountability
This element highlights the importance of receiving support from the hospital leadership to help accomplish goals. Hospital leadership can include directors of laboratory, radiology and pathology, and chief medical officer, nursing officer, and quality and safety officer. The hospital leadership can influence other departments to learn about diagnostic excellence (DxEx) and increase participation and collaboration.
2) Multidisciplinary expertise
Other professionals — such as pharmacists, social workers, nurses, therapists and technicians — are vital to the diagnostic team because they have various patient interactions. These professionals can provide insight and participate in efforts to improve diagnostic excellence.
3) Patient, family and caregiver engagement
Communication with patients and their families is important to ensure that they understand diagnoses. The CDC recommends engaging patients and families as part of the diagnostic decision-making through active listening and seeking feedback when interpreting patients’ results.
Patients and families should monitor changes in health and ask questions about their diagnoses by ensuring that they have access to their health portals and receive written instructions on how to obtain test results, if needed. Additionally, addressing patients’ and families’ concerns by creating a formal process to allow investigation and response to patient-reported diagnostic safety events allows the team to make improvements.
4) Actions
The CDC named three actions that are necessary to improve diagnoses: utilizing diagnostic stewardship, strengthening processes and systems, and identifying and learning from diagnostic safety events.
Diagnostic stewardship involves applying evidence-based actions that help clinicians decide the right diagnostic tests, leading to improved treatment decisions. Collaborating with the laboratory team can establish effective ways to improve performance, interpretation and the reporting of results, which can improve patient care and outcomes. Some actionable items include educating staff on handling specimens, implementing changes to reporting results to decrease false positives or negatives, and implementing changes to ordering tests, such as requiring providers to document indications or symptoms when ordering urine cultures.
Hospitals can help prevent gaps in diagnoses by identifying steps in processes and systems that are at risk for problems. For instance, teamwork between clinicians can help determine diagnoses.
Learning from diagnostic safety events can pinpoint areas that need improvement. The CDC suggests that DxEx teams routinely monitor safety events and provide a process for staff to express their diagnostic safety concerns.
5) Education
Education can improve DxEx by improving clinical reasoning, which is the method of identifying and prioritizing relevant information to make clinical decisions. Educating health professionals and patients about the significance of the diagnostic process and its value can lead to lower instances of missed, delayed or incorrect diagnoses.
The CDC suggests promoting understanding of clinical reasoning to learners, clinicians and hospital leaders; providing education about cognitive biases and situations in which patient characteristics and current conditions are more likely to be common; and ensuring that patients and family understand the role of testing and diagnosis.
6) Tracking and reporting
Tracking, reporting and monitoring diagnostic events using metrics can help the DxEx program achieve its goals. Surveillance through tracking and reporting allows for quantifying and identifying problems and tracking interventions. Although diagnostic stewardship tracking is most developed for infectious disease tests, such as those for UTIs and bloodstream infections, tracking can be customized by DxEx goals. The CDC suggests monitoring imaging tests and assessing rates of utilization. Improving processes and systems can help improve diagnoses by reporting diseases or conditions that need to be addressed and assessing actions and interventions that were made to improve diagnostic excellence. Using appropriate data sources to track safety events can help identify areas that have the greatest opportunities for learning and improvement. The CDC recommends reporting the types of diagnostic safety events routinely and tracking the frequency of concerns from patients and health care professionals.
Conclusion
The core elements help provide evidence-based recommendations for creating a diagnostic excellence program, which can improve diagnoses and patient care.
References:
For more information:
Connie Lau, PharmD, is a PGY1 pharmacy resident at Denver Health Medical Center.
Kati Shihadeh, PharmD, BCIDP, is a clinical pharmacy specialist in infectious diseases at Denver Health Medical Center. Shihadeh can be reached at katherine.shihadeh@dhha.org.
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