In 2023, a new analysis by ECRI and the Institute for Safe Medication Practices revealed that roughly one-third of adverse patient safety events reported by healthcare providers involved diagnostic testing errors. The analysis determined that the majority of these mistakes, nearly 70%, occurred during routine processes, such as ordering tests, collecting samples, or reporting results. Another 12% of errors took place in the monitoring and follow-up stage, while about 9% occurred during referral and consultation processes.
ECRI’s CEO, Marcus Schabacker, pointed out that diagnostic errors significantly contribute to preventable medical mishaps. He emphasized the need for a system-wide safety approach to minimize these errors, suggesting that most diagnostic errors stem from systemic failures rather than incorrect medical hypotheses from doctors. According to the analysis, less than 3% of errors were due to an incorrect initial diagnosis by physicians. Schabacker, an experienced anesthesiologist and former chief scientific officer at Baxter, clarified that the majority of issues arise not from misinterpreting test results but from flaws in the diagnostic process itself.
To improve the diagnostic process and reduce errors, ECRI provided several recommendations:
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Develop a tracking system: ECRI advises establishing electronic tracking for laboratory tests and diagnostic imaging orders, ensuring that results are reviewed and conveyed promptly to patients. Additionally, they propose creating coordination agreements between different healthcare providers and implementing early warning systems to identify high-risk patients.
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Address human factors: ECRI suggests assembling a multidisciplinary team to revamp the testing process from a human factor perspective. This includes simplifying test names and addressing potential biases and communication barriers that might influence the interactions among providers, specialists, patients, and families. Schabacker highlighted that women and people of color are 20-30% more likely to experience adverse events due to diagnostic errors, often due to biases or barriers to care.
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Engage patients and their families: It is vital to involve patients in the diagnostic process, ensuring they understand why tests are ordered and encouraging them to partake actively in their healthcare management. This approach includes using electronic tools to keep track of vulnerable patients and ensuring that all involved parties comprehend the importance of timely medical testing and follow-ups.
- Understand the role of EHRs: Electronic Health Records (EHRs) are central to the diagnostic process, yet issues often arise from their mismatch with clinicians’ cognitive processes and their design being more oriented towards billing than patient care. ECRI recommends minimizing administrative burdens and enhancing EHR systems to improve communication and diagnosis accuracy.
The context of these recommendations is further underscored by ongoing changes in the regulatory landscape, specifically the FDA’s increased oversight of laboratory developed tests (LDTs). This new rule aims to standardize testing procedures across labs, improving genetic test quality by ensuring the consistency and reliability of these tests. Schabacker noted the variability in genetic tests’ accuracy could lead to patient harm, thus stressing the importance of integrating genetic data into EHRs to avoid informational oversights that could compromise patient care.
Overall, ECRI’s analysis and recommendations call for a comprehensive overhaul of diagnostic practices in healthcare, emphasizing systematic improvements, enhanced communication, and closer engagement with patients to reduce errors and improve patient safety outcomes.
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