BY: MARK KADZIELSKI, JD, and CATHERINE MARTIN, RN, BSN, MPA
Dr. Kadzielski is head of West Coast Law Practice, Fulbright & Jaworski,
LLP, Los Angeles; Ms. Martin is director of Improvement Services, VHA West Coast,
Pleasanton, CA.
Controversy, Challenge, and a Culture of Safety
A Rhode Island hospital performed a tonsillectomy on the wrong patient because
staff confused her and another girl with a similar last name.1 Neurosurgical
instruments used by Tulane University on a patient later found to be infected
with Creutzfeldt-Jakob disease may be the cause of transmitting that illness
to eight other patients.2 Even more shocking, the Chicago Tribune's
review of 3 million patient records concluded that since 1995, at least 1,700
hospital patients had been accidentally killed and another 9,584 injured because
of nursing mistakes.3
These and other headlines of medical errors found much attention in the popular
media in 2000. Increased concern by the public about the safety of hospitals
heightened last year after the Institute of Medicine (IOM) published the report
"To Err is Human" in November 1999. This report described, in great
detail, the magnitude of medical error in U.S. health care institutions. The
report maintained that if data from studies in Utah and New York were extrapolated
to the more than 33.6 million hospital admissions in 1997, then at least 44,000
Americans — possibly up to 98,000 — die each year as a result of medical
errors. In addition, the report stated that "total national costs (lost
income, lost household production, disability, and health care costs) of preventable
adverse events (medical errors resulting in injury) are estimated to be between
$17 billion and $29 billion, of which health care costs represent over one half."4
It concluded that medical error is the eighth leading cause of death in the
United States.
Erosion of Public Trust
A recent study of 2,000 adults by the Kaiser Family Foundation reported that
a surprising number of individuals were "very concerned" about an
error resulting in injury to them or a family member in the following situations:
- 47 percent when receiving health care in general
- 47 percent when going to the hospital for care
- 40 percent when going to a physician's office for care
- 34 percent when filling a prescription at a pharmacy
- 30 percent when eating food purchased at a supermarket5
The loss of confidence regarding the quality of health care in the United States
and the huge amount of wasted dollars entrusted to the industry's stewardship
represent a serious problem for health care institutions. The U.S. health care
system is based on the Hippocratic oath and the commitment to "above all,
do no harm." Can hospitals continue to espouse mission statements that
profess to deliver high-quality care?
Catholic health care in particular is based on a ministry of caring for its
patients and improving the quality of their health and lives. Clearly, each
Catholic hospital administrator and physician leader must commit to addressing
the problem of medical errors — patients demand it.
So where do we begin? Focusing our energy on why errors happen is more productive
than disputing the number and frequency of medical errors. The delivery of health
care is complex, involving multiple providers and components and including various
degrees of specialization, all of which have a high degree of interdependency.
Overall, errors themselves are complex and occur in complicated systems. But
other highly complex industries, such as space exploration, nuclear power, and
aviation, have done substantial work in studying errors, many of which occurred
after catastrophicevents. We can learn from the work done to analyze these accidents,
such as the Three-Mile Island accident and the Challenger crash. The Challenger
failed because of a combination of brittle O-rings, unexpected cold weather,
reliance on the seals in the design of the booster, and a change in the roles
of the contractor and the National Aeronautics and Space Administration. No
one factor alone caused this crash, but the combination lead to disaster. An
accumulation of seemingly insignificant events can cause large systems to fail.
Setting a goal of "zero defects" — or no errors — in a health
care organization is unrealistic. Errors will always occur; the same systems
that produce success also produce failure. However, we can reduce their frequency
and severity by understanding the causes and building recovery into our procedures.
Procedures depend on time and sequence, and often no buffer or margin for error
exists. The best we can hope for is to build in more checks and balances (slices
of "Swiss cheese"*) to catch errors before they reach the patient.
* James Reason's work on the latent failure model of complex systems
is commonly known as the "Swiss cheese" model of error. In this
model, many different factors come together in time and space, resulting in
an error that affects the patient. The slices of Swiss cheese represent parts
of the process and often serve to deflect an error, creating a near miss.
An error occurs when the holes in the "Swiss cheese" slices line
up (failures in multiple parts of the process) and the error reaches the patient.
Health care has come late to the study of errors on an industry-wide level.
The Joint Commission on Accreditation of Health Care Organizations (JCAHO) put
in place requirements for "sentinel event" reporting and investigation
just a few years ago to encourage hospitals to investigate errors and to begin
a central system for collecting and analyzing the information. Reporting of
such events — defined as an unexpected occurrence involving death or serious
physical or psychological injury — has lead to issuance of "sentinel
event alerts" from JCAHO regarding common errors or procedures that have
caused patient harm. The most notable alert recounted the misadministration
of concentrated potassium chloride in nursing units, including neonatal and
intensive care units. The alert recommended removal of this compound from nursing
units, which, because of packaging similarities, can be mistaken for more commonly
administered pharmaceuticals. No subsequent patient deaths related to concentrated
potassium chloride have occurred since this alert was published. The study of
sentinel events and the completion of the JCAHO-required "root cause analysis"
(an examination of underlying organizational systems and procedures) force hospitals
to attempt to identify causative factors for error, which can then be addressed.
JCAHO's latest recommendation is to apply this method to identified near
misses as well.
Types of Errors
Although Catholic health care acknowledges the complexity of systems and the
fallibility of human beings, leaders still must work to prevent as many errors
affecting patients as possible. Our goal should be to rekindle confidence in
health care and develop the trust of our patients and physicians. Prevention
of error begins with understanding the four types of error:
- Execution error, which involves a planned action that was not completed
as intended
- Planning error, in which the intended action is incorrect
- Active error, which is error by the frontline staff
- Latent error, which involves procedural flaws that led to operator error
According to the first IOM report, most responses to error tend to focus on
active error. Scrutinizing the person closest to the error is the most obvious
approach. However, examining latent error is a more effective way to make the
system safer. JCAHO's requirement of a credible root cause analysis was
implemented to attempt to force health care institutions to look past the active
error and investigate further to find any applicable latent error.
Many other factors contribute to medical error, including some acute health
care delivery systems that developed after World War II and have not changed
since inception. Organizational factors include the institution's
culture, workflow design, staffing levels, reliance on mandatory overtime, and
overall resources allocated for patient care delivery. Ergonomic factors,
such as lighting, noise, design of equipment and furniture, legibility of labels,
positioning of controls, and confusingly similar designs, also contribute to
error. Human vulnerabilities of poor planning ability, poor short-term
memory, poor problem-solving ability, and limited attention span are also complications.
Situational factors abound in health care and include fatigue, stress,
illness, and sensory overload. (How can hospitals require a registered nurse
to work mandatory overtime when the Federal Aviation Administration grounds
pilots who have not have at least eight hours of rest after a 10-hour shift?)
Cognitive lapses contribute to error in the form of overconfidence, overgeneralization,
reversion to the familiar when under stress, and confirmation bias (looking
for something that confirms what one believes). External factors that
may contribute to error include regulations, litigation, payors, and consumers.
The Current Culture of Blame
Hospital and physician leaders will confront many barriers in their attempt
to study medical error. Identifying and addressing these barriers is the first
step in the process. The first is admitting that errors occur; the second is
resistance to change. Others include resistance to "cookbook" medicine
and guidelines, fear of discipline or retaliation, failure to appreciate the
complexity of health care, hindsight bias, and financial limitations. Other
types of barriers are societal: the growing lack of trust in the health care
system, the need to blame someone, and the need to rationalize a negative event.
Last, but certainly not the least, are legal and political barriers. Health
care providers are caught up in a civil legal system (involving fault-finding
under tort law), a regulatory system, and a criminal justice system, all of
which create an unusual and burdensome context in which to address medical errors.
Moreover, concerns about liability of medical errors in the tort system are,
frankly, not the most compelling in the day-to-day health care environment;
professional liability exposure is usually not determined until years after
an incident occurs. More important is the increasingly aggressive approach of
federal and state surveyors from agencies such as Centers for Medicare and Medicaid
Services and the Department of Health. These agencies respond immediately to
notification of medical errors by conducting multiple surveys and finding numerous
faults in the quality of care. Deviations from standards are noted as deficiencies
by governmental agencies, thus subjecting health care providers to loss of licensure
and reimbursement.
The criminalization of health care, as shown by recent selective and successful
criminal prosecutions of health care providers for errors in judgment, has raised
the specter of personal exposure. Legislating corrective action to address medical
error is not the most effective way to handle this issue and clearly will not
resolve the errors. Indeed, creating more regulatory and criminal exposure might
well drive the reporting and discussion of medical errors underground, thus
having a negative effect on performance improvement.
The 2001 IOM Report
On March 1, 2001, The IOM released a second report on its investigation into
the safety of health care in the United States. "Crossing the Quality Chasm:
A New Health System for the 21st Century" focused on 13 specific recommendations
in four general themes designed to provide a road map for organizations to use
in their efforts to improve patient safety.6 The themes are vision,
redesign of the delivery system, building organizational support for change,
and environmental change. The report stated that health care should be:
- Safe — avoiding injuries to patients from care intended to help them
- Effective — providing services based on scientific knowledge to all who
can benefit and refraining from providing services to those not likely to
benefit
- Patient-centered — providing care respectful of and responsive to individual
patient preferences, needs, and values and ensuring that patient values guide
all clinical decisions
- Timely — reducing wait times and sometimes harmful delays for those who
receive and those who give care
- Efficient — avoiding waste, including waste of equipment, supplies, ideas,
and energy
- Equitable — providing care that does not vary in quality because of personal
characteristics such as sex, ethnicity, geographic location, or socioeconomic
status6
The Catholic health care ministry focuses on a common vision, which includes
patient-centered care with attention to stewardship and a commitment rooted
in the human dignity of all persons. The efforts to address what health care
"should be" will be easier to achieve as Catholic leadership reminds
staff and medical partners about this special focus.
Although many health care leaders are uncomfortable with the increasing scrutiny
of their organizations by non-medical professionals, they will come to see that
the attention can be positive if actions are taken to reduce the frequency and
severity of medical error. Catholic health care professionals, physicians, and
administrators persevere in this complex and very difficult environment of patient
care because of their commitment to continuing Jesus' healing ministry.
Health care organizations uniquely grounded in a religious commitment have an
advantage in addressing the barriers and issues that contribute to medical errors.
The Catholic values of preserving human dignity, focusing on the common good,
and advocating care of the needy are reflected by system leadership. Catholic
health care is thus well positioned to improve patient safety.
On the heels of the second IOM report, U.S. Health and Human Services Department
Secretary Tommy G. Thompson announced the formation of a patient safety task
force to coordinate a joint effort among several federal agencies to collect
data on patient safety. The secretary has charged the Agency for Health Care
Research and Quality, the Centers for Disease Control and Prevention, the Food
and Drug Administration, and the Centers for Medicare and Medicaid Services
to identify the data that health care providers, states, and other agencies
need to collect to improve patient safety. The announcement included a statement
that this plan will provide "those who must submit reports an opportunity
to learn," suggesting a mandatory reporting structure.
New JCAHO Standards in 2001
New JCAHO standards that focus on medical error reduction in hospitals and
patient safety were implemented July 1, 2001. They were added to the JCAHO-named
areas of leadership, improving organizational performance, and management of
information. A new emphasis on patient safety was added to patient rights, education
of patients and families, continuity of care, and management of human resources.
The major focus of these new standards is on organizational leadership and the
development of a culture of safety. The standards state that hospital leaders
are to create an environment that:
- Encourages error identification and remedial steps to reduce the likelihood
of future or recurring errors
- Minimizes individual blame or retribution to those involved in or who report
an error
- Establishes an organization-wide patient safety program that uses both internal
and external knowledge and experience to prevent errors
One of the most controversial new standards challenges the way hospitals currently
address errors that result in patient injury. This requirement, in the JCAHO
category of patient rights, states that the patient and/or the patient's
family must be informed about results of care, including unanticipated outcomes.
In the past, health care organizations have had to consider liability and resultant
legal actions when investigating medical errors, often choosing not to fully
inform the patient or family. This standard forces organizations to work toward
a culture of safety and full disclosure of medical error to those affected.
As the IOM report states, "It may be part of human nature to err, but
it is also part of human nature to create solutions, find better alternatives
and meet the challenges ahead."7 Harnessing this motivation
and recapturing the public's trust and confidence that each organization
will provide high-quality treatment is a special challenge to Catholic health
care.
NOTES
- Patient Safety Monitor, December 27, 2000, vol. 1, no. 51.
- Patient Safety Monitor, November 3, 2000, vol. 1, no. 48.
- Chicago Tribune, September 10-12, 2000.
- G. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, editors, To
Err Is Human, Institute of Medicine, National Academy Press, November
1999.
- A. K. Hallam, "An Erosion of Trust: Survey Finds Consumers Fear Medical
Errors and Want Better Protection From Such Mistakes," Modern Healthcare,
December 18, 2000, pp. 30-31.
- Committee on Quality Health Care in America, Crossing the Quality Chasm:
A New Health System for the 21st Century, Institute of Medicine, National
Academy Press, March 2001, pp. 5-20.
- Crossing the Quality Chasm, pp. 5-20.
Copyright © 2001 by the Catholic Health Association of the United States
For reprint permission, contact Betty Crosby or call (314) 253-3477.