Editorials
Constancy of Purpose for Improving Patient Safety
— Missing in Action
Donald M. Berwick, M.D., M.P.P.
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 improve-
ment.”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 Medi-
cine) titled, “To Err Is Human: Building a Safer
Health System,”2 improving patient safety was a
priority in U.S. health care. That report rested on
a strong foundation of empirical research —
with the f lagship 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 re-
port 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 ve-
hicle accidents and breast cancer.
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 pay-
ment. 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 col-
leagues3 have attempted to estimate progress in
patient safety by replicating the methods of the
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HMPS in a sample of 2809 admissions in 11
Massachusetts hospitals in 2018 — 34 years af-
ter 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 at-
tempt was also made to distinguish “prevent-
able” 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 decom-
pensating 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 includ-
ed an adverse event that was rated as serious
(i.e., caused harm that resulted in substantial in-
tervention or prolonged recovery), life-threaten-
ing, or fatal. Overall, 22.7% of the adverse events
were judged to be preventable. The types of ad-
verse events that were identified were consistent
with those previously reported in the literature:
39.0% were adverse drug events (defined as inju-
ries 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) infec-
tions. 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 find-
ings of this study with those of the HMPS is
tempting but is not warranted. Bates and col-
leagues used search methods that were guaran-
teed to identify more injuries than the methods
used in the HMPS, and their definition of an
adverse event was broader. However, the inci-
dence of adverse events that were identified
(23.6%) does not suggest dramatic progress.
181
 Editorials

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 na-
tional action plan for patient safety sponsored by
the Agency for Healthcare Research and Qual-
ity,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 move-
ment. 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
models, staff burnout, and decarbonization, to
name a few. They may not welcome the duty to
push patient safety back to strategic promi-
nence. Nevertheless, “first do no harm” remains
a sacred obligation for all in health care, and
success requires “constancy of purpose for im-
provement.” Without renewed board and execu-
tive 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, fami-
lies, and health care staff paying the price for
inaction.
Disclosure forms provided by the author are available with the
full text of this editorial at NEJM.org.
From the Institute for Healthcare Improvement, Boston.

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 practi-
tioners 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, pre-
paredness, supply-chain shortages, new payment
1. Deming WE. Out of the crisis. Cambridge, MA:​MIT Press,
2000.
2. Kohn LT, Corrigan JM, Donaldson MS. To err is human:
building a safer health system. Washington, DC:​National Acad-
emies Press, 2000.
3. Bates DW, Levine DM, Salmasian H, et al. The safety of in-
patient health care. N Engl J Med 2023;​388:​142-53.
4. Institute for Healthcare Improvement. Declaration to advance
patient safety. May 2022 (https://241684​.­fs1​.­hubspotusercontent​
-­na1​.­net/​­hubfs/​­241684/​­National%20Action%20Plan%20(NAP)/​­IHI​
-­NSC_Declaration​-­to​-­Advance​-­Patient​-­Safety​.­pdf).
5. Agency for Healthcare Research and Quality. Safer together:
a national action plan to advance patient safety. November 2022
(https://www​.­ahrq​.­gov/​­patient​-­safety/​­reports/​­safer​-­together​.­html).
6. Classen DC, Griffin FA, Berwick DM. Measuring patient
safety in real time: an essential method for effectively improving
the safety of care. Ann Intern Med 2017;​167:​882-3.
DOI: 10.1056/NEJMe2213567
Copyright © 2023 Massachusetts Medical Society.

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