Constancy of Purpose for Improving Patient Safety — Missing in Action
Donald M. Berwick
N Engl J Med 2023; 388:181-182
DOI: 10.1056/NEJMe2213567
The 20th-century statistician and quality scholar W. Edwards Deming proposed the “14 Points for Top Leaders” — a checklist of management principles for executives who wish to nurture improvement in complex systems. First on his list was “constancy of purpose for improvement.”1 In Deming’s view, when leaders slacken their visible commitment to a goal, progress slows or stalls.
For a period of time after the publication of the 2000 report by the Institute of Medicine (now known as the National Academy of Medicine) titled, “To Err Is Human: Building a Safer Health System,”2improving patient safety was a priority in U.S. health care. That report rested on a strong foundation of empirical research — with the flagship study being the Harvard Medical Practice Study (HMPS) — and progress in safety science (largely in other industries), such as studies of human error, cognition, team dynamics, and resilience. The authors of the report famously estimated the number of lives lost to the consequences of errors in health care to be 44,000 to 98,000 per year in hospitals alone, thereby flagging shortcomings in patient safety as a public health threat as large as motor vehicle accidents and breast cancer.
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Subsequently, a decade-long burst of strategic activities to improve patient safety occurred; these activities included national campaigns, research studies, training programs for patient safety officers, and changes in Medicare payment. Measuring the results of these initiatives proved difficult because they were confounded by deficient data and a lack of standardized methods, but there were inklings of progress against specific threats, such as some hospital-acquired infections. Despite such progress, a firm answer to even the most basic question has been elusive: Has the nation made progress or not since “To Err Is Human: Building a Safer Health System” rang the alarm?
In this issue of the Journal, Bates and colleagues3 have attempted to estimate progress in patient safety by replicating the methods of the HMPS in a sample of 2809 admissions in 11 Massachusetts hospitals in 2018 — 34 years after the New York hospital records were sampled in the HMPS. As in the HMPS, trained nurses reviewed the records to identify admissions that included possible adverse events, and trained physicians then validated the findings; an attempt was also made to distinguish “preventable” adverse events from other adverse events. However, unlike in the HMPS, a trigger tool was used to help flag suspicious records, and all the records were scrutinized for certain types of harm that were not examined in the HMPS, such as diagnostic errors and failure to treat decompensating patients.
The authors’ findings are disturbing. At least one adverse event was identified in 23.6% of the admissions, and 9.0% of the admissions included an adverse event that was rated as serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery), life-threatening, or fatal. Overall, 22.7% of the adverse events were judged to be preventable. The types of adverse events that were identified were consistent with those previously reported in the literature: 39.0% were adverse drug events (defined as injuries resulting from drugs that were taken), 30.4% were events related to a surgical or other procedure, 15.0% were events related to general patient care (such as falls), and 11.9% were hospital-acquired (health care–associated) infections. The mean length of stay for admissions during which an adverse event occurred was more than twice as long as that for admissions without an adverse event: 9.3 days as compared with 4.2 days.
A direct comparison of the quantitative findings of this study with those of the HMPS is tempting but is not warranted. Bates and colleagues used search methods that were guaranteed to identify more injuries than the methods used in the HMPS, and their definition of an adverse event was broader. However, the incidence of adverse events that were identified (23.6%) does not suggest dramatic progress. On the contrary, these findings suggest that the safety movement has, at best, stalled.
The 2022 National Steering Committee for Patient Safety,4 as well as the authors of a national action plan for patient safety sponsored by the Agency for Healthcare Research and Quality,5 reached the same conclusion. The President’s Council of Advisors on Science and Technology has been preparing recommendations for the President to reignite an effective safety movement. This effort could hardly be timelier.
The study by Bates and colleagues illustrates several of the difficulties in tracking safety. First, event rates are highly sensitive to the method of review. Essentially, the harder one looks for hazards and patient injuries, the more one finds. (Voluntary reporting is so unreliable as to be nearly worthless in the calculation of rates.) Second, judging “preventability” is not only difficult but may also be misleading. The more valuable approach is to regard all injuries as potentially preventable. Third, safety practitioners in other industries pay as much attention to “near misses” as to actual injuries, a topic that neither this report nor the HMPS addressed. Finally, although the use of efficient, automated tools for detecting harm in electronic medical records is now well described,6 few health care organizations are using them. Finding harm therefore remains very costly.
Senior executives and boards of directors in health care systems today may feel overwhelmed by an onslaught of urgent priorities: equity, preparedness, supply-chain shortages, new payment models, staff burnout, and decarbonization, to name a few. They may not welcome the duty to push patient safety back to strategic prominence. Nevertheless, “first do no harm” remains a sacred obligation for all in health care, and success requires “constancy of purpose for improvement.” Without renewed board and executive leadership and accountability for safety and without concerted, persistent investment in and monitoring of change, a summary study 34 years from now may again look all too familiar, with millions upon millions of patients, families, and health care staff paying the price for inaction.
