From Wikipedia, the free encyclopedia
Patient safety is a new healthcare discipline
that emphasizes the reporting, analysis, and prevention of medical error that
often lead to adverse
healthcare events. The frequency and magnitude of avoidable
adverse patient events was not well known until the 1990s, when
multiple countries reported staggering numbers of patients harmed
and killed by medical errors. Recognizing that healthcare errors
impact 1 in every 10 patients around the world, the World Health Organization
calls patient safety an endemic concern. Indeed,
patient safety has emerged as a distinct healthcare discipline
supported by an immature yet developing scientific framework. There
is a significant transdisciplinary body of theoretical and research
literature that informs the science of patient safety. The
resulting patient safety knowledge continually informs improvement
efforts such as: applying lessons learned from business and
industry, adopting innovative technologies, educating providers and
consumers, enhancing error reporting systems, and developing new
Prevalence of adverse
Greek physician treating a patient, ca. 480-470 BC (Louvre Museum,
Millennia ago, Hippocrates recognized the potential for injuries
that arise from the well intentioned actions of healers. Greek
healers in the 4th Century B.C., drafted the Hippocratic
Oath and pledged to "prescribe regimens for the good of my
patients according to my ability and my judgment and never do harm
to anyone." Since
then, the directive primum non nocere (“first do no harm)
has become a central tenet for contemporary medicine. However,
despite an increasing emphasis on the scientific basis of medical practice in Europe
and the United States in the late 19th Century, data on adverse
outcomes were hard to come by and the various studies commissioned
collected mostly anecdotal events.
In the United States, the public and the medical specialty of anesthesia were shocked
in April 1982 by the ABC television program 20/20 entitled The Deep
Sleep. Presenting accounts of anesthetic accidents, the
producers stated that, every year, 6,000 Americans die or suffer
brain damage related to these mishaps. In
1983, the British Royal Society of Medicine and
the Harvard Medical School jointly
sponsored a symposium on anesthesia deaths and injuries, resulting
in an agreement to share statistics and to conduct studies. By 1984
the American Society of Anesthesiologists had established the
Anesthesia Patient Safety Foundation. The APSF marked the first use
of the term "patient safety" in the name of professional reviewing
Although anesthesiologists comprise only about 5% of physicians in
the United States, anesthesiology became the leading medical
specialty addressing issues of patient safety.
Likewise in Australia, the Australian
Patient Safety Foundation was founded in 1989 for anesthesia
error monitoring. Both organizations were soon expanded as the
magnitude of the medical error crisis became known.
To Err is
In the United States, the full magnitude and impact of errors in
health care was not appreciated until the 1990s, when several
reports brought attention to this issue.
In 1999, the Institute of Medicine (IOM) of
the National Academy of Sciences released a report, To Err is
Human: Building a Safer Health System.
The IOM called for a broad national effort to include establishment
of a Center for Patient Safety, expanded reporting of adverse
events, development of safety programs in health care
organizations, and attention by regulators, health care purchasers,
and professional societies. The majority of media attention,
however, focused on the staggering statistics: from 44,000 to
98,000 preventable deaths annually due to medical error, 7,000
preventable deaths related to medication errors alone. Within 2
weeks of the report's release, Congress began hearings and
President Clinton ordered a government-wide study of the
feasibility of implementing the report's recommendations.
Initial criticisms of the methodology in the IOM estimates
focused on the statistical methods of amplifying low numbers of
incidents in the pilot studies to the general population. However,
subsequent reports emphasized the striking prevalence and
consequences of medical error. In July 2004, Healthgrades, a
leading health care ratings organization, published a study,
Patient Safety in American Hospitals, concluding that
there were over one million adverse events associated with Medicare hospitalizations
during 2000–2002, resulting in up to 195,000 accidental deaths per
year in American hospitals.
The experience has been similar in other countries.
- Ten years after a groundbreaking Australian study revealed
18,000 annual deaths from medical errors,
Professor Bill Runciman, one of the study's authors and president
of the Australian
Patient Safety Foundation since its inception in 1989, reported
himself a victim of a medical dosing error.
- The Department of Health Expert Group in June 2000 estimated
that over 850,000 incidents harm National Health Service
hospital patients in the United Kingdom each year. On average
forty incidents a year contribute to patient deaths in each NHS
- In 2004, the Canadian Adverse Events Study found that adverse
events occurred in more than 7% of hospital admissions, and
estimated that 9,000 to 24,000 Canadians die annually after an
avoidable medical error.
- These and other reports from New Zealand,
developing countries have
led the World Health Organization to
estimate that one in ten persons receiving health care will suffer
Causes of healthcare
- See also Healthcare error and Healthcare error
The simplest definition of a health care error is a preventable
effect of care, whether or not it is evident or harmful to the
patient. A conservative average of both the Institute of Medicine and
HealthGrades reports indicates that there have been between
400,000-1.2 million error-induced deaths during 1996–2006 in the
United States. These casualties have been, in part, attributed
- Human Factors
- Variations in healthcare provider training &
depression and burnout.
- Diverse patients, unfamiliar settings, time pressures.
- Failure to acknowledge the prevalence and seriousness of
- Medical complexity
- Complicated technologies, powerful drugs.
- Intensive care, prolonged hospital stay.
- System failures
- Poor communication, unclear lines of authority of physicians,
nurses, and other care providers.
- Complications increase as patient to nurse staffing ratio
- Disconnected reporting systems within a hospital: fragmented
systems in which numerous hand-offs of patients results in lack of
coordination and errors.
- Drug names that look alike or sound alike.)
- The impression that action is being taken by other groups
within the institution.
- Reliance on automated systems to prevent error.
- Inadequate systems to share information about errors hamper
analysis of contributory causes and improvement strategies.
- Cost-cutting measures by hospitals in response to reimbursement
- Environment and design factors. In emergencies, patient care
may be rendered in areas poorly suited for safe monitoring. The
American Institute of Architects has identified concerns for the
safe design and construction of health care facilities.
- Infrastructure failure. According to the WHO, 50% of medical equipment
in developing countries is only partly usable due to lack of
skilled operators or parts. As a result, diagnostic procedures or
treatments cannot be performed, leading to substandard
Commission's Annual Report on Quality and Safety 2007 found
that inadequate communication between healthcare providers, or
between providers and the patient and family members, was the root
cause of over half the serious adverse events in accredited
leading causes included inadequate assessment of the patient's
condition, and poor leadership or training.
Common misconceptions about adverse events are:
- "'Bad apples' or incompetent health care providers are a common
cause." Many of the errors are normal human slips or lapses, and
not the result of poor judgment or recklessness.
- "High risk procedures or medical specialties are responsible
for most avoidable adverse events". Although some
mistakes, such as in surgery, are easier to notice, errors occur in
all levels of care.
Even though complex procedures entail more risk, adverse outcomes
are not usually due to error, but to the severity of the condition
However, USP has reported that
medication errors during the course of a surgical procedure are
three times more likely to cause harm to a patient than those
occurring in other types of hospital care.
- "If a patient experiences an adverse event during the process
of care, an error has occurred". Most medical care entails some
level of risk, and there can be complications or side effects, even
unforeseen ones, from the underlying condition or from the
Initiatives in patient
Safety programs in
- Aviation safety
- In the United States, two organizations contribute to one of
the world's lowest aviation accident rates.
Mandatory accident investigation is carried out by the National
Transportation Safety Board, while the Aviation Safety Reporting
System receives voluntary reports to identify deficiencies and
provide data for planning improvements. The latter system is
confidential and provides reports back to stakeholders without regulatory
action. Similarities and contrasts have been noted between the
"cultures of safety" in medicine and aviation.
Pilots and medical personnel operate in complex environments,
interact with technology, and are subject to fatigue, stress,
danger, and loss of life and prestige as a consequence of
the enviable record of aviation in accident prevention,
a similar medical adverse event system would include both mandatory
(for severe incidents) and voluntary non-punitive reporting,
teamwork training, feedback on performance and an institutional
commitment to data collection and analysis. The Patient Safety
Reporting System (PSRS) is a program modeled upon the Aviation
Safety Reporting System and developed by the Department of
Veterans Affairs (VA) and the National Aeronautics and Space
Administration (NASA) to monitor patient safety through
voluntary, confidential reports.
- Near-miss reporting
- A near miss is an unplanned event that did not result in
injury, illness, or damage - but had the potential to do so.
Reporting of near misses by observers is an established error
reduction technique in aviation,
and has been extended to private industry, traffic safety and
fire-rescue services with reductions in accidents and injury. AORN, a US-based professional
organization of perioperative registered nurses, has put in effect
a voluntary near miss reporting system (SafetyNet ),
covering medication or transfusion reactions, communication or
consent issues, wrong patient or procedures, communication
breakdown or technology malfunctions. An analysis of incidents
allows safety alerts to be issued to AORN members.
- Limits of the industrial safety model
- Unintended consequences may
occur as improvements in safety are undertaken. It may not be
possible to attain maximum safety goals in healthcare without
adversely affecting patient care in other ways. An example is blood
transfusion; in recent years, to reduce the risk of transmissible
infection in the blood supply, donors with only a small probability
of infection have been excluded. The result has been a critical
shortage of blood for other lifesaving purposes, with a broad
impact on patient care.
Application of high-reliability theory and normal accident theory
can help predict the organizational consequences of implementing
Technology in Healthcare
According to a study by RAND Health, the U.S. healthcare system
could save more than $81 billion annually, reduce adverse
healthcare events, and improve the quality of care if health
information technology (HIT) is widely adopted. The
most immediate barrier to widespread adoption of technology is cost
despite the patient benefit from better health, and payer benefit
from lower costs. However, hospitals pay in both higher costs for
implementation and potentially lower revenues (depending on
reimbursement scheme) due to reduced patient length of stay. The
benefits provided by technological innovations also give rise to
serious issues with the introduction of new and previously unseen
Types of Healthcare
Handwritten reports or notes, manual order entry, non-standard
abbreviations and poor legibility lead to substantial errors and
injuries, according to the IOM (2000) report.
The follow-up IOM report, Crossing the Quality Chasm: A New
Health System for the 21st Century, advised rapid adoption of
electronic patient records, electronic medication ordering, with
computer- and internet-based information systems to support
clinical decisions. This
section contains only the patient safety related aspects of
Electronic Health Record
The Electronic health record
(EHR), previously known as the Electronic medical record
(EMR), reduces several types of errors, including those related to
prescription drugs, to emergent and preventive care, and to tests
Important features of modern EHR include automated
drug-drug/drug-food interaction checks and allergy checks, standard
drug dosages and patient education information. Also, these systems
provide recurring alerts to remind clinicians of intervals for
preventive care and to track referrals and test results. Clinical
guidelines for disease management have a demonstrated benefit when
accessible within the electronic record during the process of
treating the patient.
Advances in health informatics and widespread
adoption of interoperable electronic health records promise access
to a patient's records at any health care site. Still, there may be
a weak link because of physicians' deficiencies in understanding
the patient safety features of e.g. government approved
Portable offline emergency medical record devices have been
developed to provide access to health records during widespread or
extended infrastructure failure, such as in natural disasters or
Provider Order Entry (CPOE)
Prescribing errors are the largest identified source of
preventable errors in hospitals (IOM, 2000; 2007). The IOM (2006)
estimates that each hospitalized patient, on average, is exposed to
one medication error each day.
Computerized provider order entry (CPOE), formerly called computer physician order
entry, can reduce medication errors by 80% overall but more
importantly decrease harm to patients by 55%. A Leapfrog (2004) survey found that 16% of US
clinics, hospitals, and medical practices are expected to utilize
CPOE within 2
- Complete Safety Medication System
A standardized bar code system for dispensing drugs might
prevent 25% of drug errors.
Despite ample evidence to reduce medication errors, compete
medication delivery systems (barcoding and Electronic prescribing) have
slow adoption by doctors and hospitals in the United States, due to
concern with interoperability and compliance with future national
concerns are not inconsequential; standards for electronic
prescribing for Medicare Part D conflict with
regulations in many US states.
Technology induced errors are significant and increasingly more
evident in care delivery systems. This
idiosyncratic and potentially serious problems associated with HIT
implementation has recently become a tangible concern for
healthcare and information technology professionals. As such, the
term technological iatrogenesis describes this new category of
adverse events that are an emergent property resulting from
technological innovation creating system and microsystem
Healthcare systems are complex and adaptive, meaning there are many
networks and connections working simultaneously to produce certain
outcomes. When these systems are under the increased stresses
caused by the diffusion of new technology, unfamiliar and new
process errors often result. If not recognized, over time these new
errors can collectively lead to catastrophic system failures. The
term “e-iatrogenesis”  can
be used to describe the local error manifestation. The sources for
these errors include:
- Prescriber and staff inexperience may lead to a false sense of
security; that when technology suggests a course of action, errors
- Shortcut or default selections can override non-standard
medication regimens for elderly or underweight patients, resulting
in toxic doses.
- CPOE and automated drug dispensing was identified as a cause of
error by 84% of over 500 health care facilities participating in a
surveillance system by the United
- Irrelevant or frequent warnings can interrupt work flow.
Solutions include ongoing changes in design to cope with unique
medical settings, supervising overrides from automatic systems, and
training (and re-training) all users.
integrates an individual doctor's exam and diagnostic skills for a
specific patient, with the best available evidence from medical
research. The doctor's expertise includes both diagnostic skills
and consideration of individual patient's rights and preferences in
making decisions about his or her care. The clinician uses
pertinent clinical research on the accuracy of diagnostic tests and
the efficacy and safety of therapy, rehabilitation, and prevention
to develop an individual plan of care. The
development of evidence-based recommendations for specific medical
conditions, termed clinical practice
guidelines or "best practices", has accelerated in the past few
years. In the United States, over 1,700 guidelines (see example
image, right) have been developed as a resource for physicians to
apply to specific patient presentations.
National Institute for Health and Clinical Excellence (NICE) in
the United Kingdom provides detailed "clinical guidance" for both
health care professionals and the public about specific medical
- Evidence-based medicine may reduce adverse events, especially
those involving incorrect diagnosis, outdated or risky tests or
procedures, or medication overuse.
- Clinical guidelines provide a common framework for improving
communication among clinicians, patients and non-medical purchasers
of health care.
- Errors related to changing shifts or multiple specialists are
reduced by a consistent plan of care.
- Information on the clinical effectiveness of treatments and
services can help providers, consumers and purchasers of health
care make better use of limited resources.
- As medical advances become available, doctors and nurses can
keep up with new tests and treatments as guidelines are
- Managed care plans may attempt limit "unnecessary" services to
cut the costs of health care, despite evidence that guidelines are
not designed for general screening, rather as decision-making tools
when an individual practitioner evaluates a specific patient.
- The medical literature is evolving and often controversial;
development of guidelines requires consensus.
- Implementing guidelines and educating the entire health care
team within a facility costs time and resources (which may be
recovered by future efficiency and error reduction).
- Clinicians may resist evidence-based medicine as a threat to
traditional relationships between patients, doctors and other
health professionals, since any participant can influence
- Failing to follow guidelines might increase the risk of liability or disciplinary action by
and safety initiatives in community pharmacy practice
Community pharmacy practice is making important advances in the
quality and safety movement despite the limited number of federal
and state regulations that exist and in the absence of national
accreditation organizations such as the Joint Commission - a
driving force for performance improvement in health care systems.
Community pharmacies are using automated drug dispensing devices
(robots), computerized drug utilization review tools, and most
recently, the ability to receive electronic prescriptions from
prescribers to decrease the risk for error and increase the
likelihood of delivering high quality of care.
Quality Assurance (QA) in community practice is a relatively new
concept. As of 2006, only 16 states have some form of legislation
that regulates QA in community pharmacy practice. While most state
QA legislation focuses on error reduction, North Carolina has
recently approved legislation that
requires the pharmacy QA program to include error reduction
strategies and assessments of the quality of their pharmaceutical
care outcomes and pharmacy services.
literacy is a common and serious safety concern. A study of
2,600 patients at two hospitals determined that between 26-60% of
patients could not understand medication directions, a standard informed
consent, or basic health care materials. This
mismatch between a clinician's level of communication and a
patient's ability to understand can lead to medication errors and
The Institute of Medicine (2004)
report found low health literacy levels negatively affects
healthcare outcomes. In
particular, these patients have a higher risk of hospitalization
and longer hospital stays, are less likely to comply with
treatment, are more likely to make errors with medication, and
are more ill when they seek medical care.
Pay for performance
Pay for performance systems link compensation to measures of
work quality or goals. As of 2005, 75 percent of all U.S. companies
connect at least part of an employee's pay to measures of
performance, and in healthcare, over 100 private and federal pilot
programs are underway. Current methods of healthcare payment may
actually reward less-safe care, since some insurance companies will
not pay for new practices to reduce errors, while physicians and
hospitals can bill for additional services that are needed when
patients are injured by mistakes.
However, early studies showed little gain in quality for the money
well as evidence suggesting unintended consequences, like the
avoidance of high-risk patients, when payment was linked to outcome
2006 Institute of Medicine report Preventing Medication
Errors recommended "incentives...so that profitability of
hospitals, clinics, pharmacies, insurance companies, and
manufacturers (are) aligned with patient safety goals;...(to)
strengthen the business case for quality and safety."
There is widespread international interest in health care
pay-for-performance programs in a range of countries, including the
In the United Kingdom, the National Health Service (NHS)
began a ambitious pay for performance initiative in 2004, known as
the Quality and Outcomes Framework (QOF).
General practitioners agreed to increases in existing income
according to performance with respect to 146 quality indicators
covering clinical care for 10 chronic diseases, organization of
care, and patient experience. Unlike proposed quality incentive
programs in the United States, funding for primary care was
increased 20% over previous levels. This allowed practices to
invest in extra staff and technology; 90% of general
practitioners use the NHS Electronic
Prescription Service, and up to 50% use electronic health records for
the majority of clinical care. Early analysis showed that
substantially increasing physicians’ pay based on their success in
meeting quality performance measures is successful. The 8,000
family practitioners included in the study earned an average of
$40,000 more by collecting nearly 97% of the points available.
A component of this program, known as exception
reporting, allows physicians to use criteria to exclude
individual patients from the quality calculations that determine
physician reimbursement. There was initial concern that exception
reporting would allow inappropriate exclusion of patients in whom
targets were missed ("gaming").
However, a 2008 study has shown little evidence of widespread
In the United States, Medicare has various
pay-for-performance ("P4P") initiatives in offices, clinics and
hospitals, seeking to improving quality and avoid unnecessary
health care costs. The
Medicare and Medicaid Services (CMS) has several demonstration
projects underway offering compensation for improvements:
- Payments for better care coordination between
home, hospital and offices for patients with chronic illnesses. In
April 2005, CMS launched its first value-based purchasing pilot or
"demonstration" project- the three-year Medicare Physician Group
Practice (PGP) Demonstration. The
project involves ten large, multi-specialty physician practices
caring for more than 200,000 Medicare fee-for-service
beneficiaries. Participating practices will phase in quality
standards for preventive care and the management of common chronic
illnesses such as diabetes. Practices meeting these standards will
be eligible for rewards from savings due to resulting improvements
in patient management. The First Evaluation Report to
Congress in 2006 showed that the model rewarded high quality,
efficient provision of health care, but the lack of up-front
payment for the investment in new systems of case management "have
made for an uncertain future with respect for any payments under
- A set of 10 hospital quality measures which,
if reported to CMS, will increase the payments that hospitals
receive for each discharge. By the third year of the demonstration,
those hospitals that do not meet a threshold on quality will be
subject to reductions in payment. Preliminary data from the second
year of the study indicates that pay for performance was associated
with a roughly 2.5% to 4.0% improvement in compliance with quality
measures, compared with the control hospitals.
Dr. Arnold Epstein of the Harvard School of Public Health commented
in an accompanying editorial that pay-for-performance "is
fundamentally a social experiment likely to have only modest
Unintended consequences of some publicly reported hospital quality
measures have adversely affected patient care. The requirement to
give the first antibiotic dose in the emergency department within 4
hours, if the patient has pneumonia, has caused an increase in
- Rewards to physicians for improving health
outcomes by the use of health information technology in the
care of chronically ill Medicare patients.
- Disincentives: The 2006 Tax Relief &
Health Care Act of 2006 required the HHS Inspector General to study ways that Medicare
payments to hospitals could be recouped for "never events", as
defined by the National
Quality Forum, including hospital infections. In
August 2007, CMS announced that it will stop payments to hospitals
for several negative consequences of care that result in injury,
illness or death. This rule, effective October 2008, would reduce
hospital payments for eight serious types of preventable incidents:
objects left in a patient during surgery, blood transfusion reaction, air embolism, falls,
infections from catheters, pressure ulcer, and
sepsis from catheters.
Reporting of "never events" and creation of performance benchmarks
for hospitals are also mandated. Other private health payers are
considering similar actions; in 2005, HealthPartners, a Minnesota
health insurer, chose not to cover 27 types of "never events". The
Leapfrog Group has announced that will work
with hospitals, health plans and consumer groups to advocate
reducing payment for "never events", and will recognize hospitals
that agree to certain steps when a serious avoidable adverse event
occurs in the facility, including notifying the patient and patient safety
organizations, and waiving costs.
Physician groups involved in the management of complications, such
as the Infectious Diseases Society of America, have voiced
objections to these proposals, observing that "some patients
develop infections despite application of all evidence-based
practices known to avoid infection", and that a punitive response
may discourage further study and slow the dramatic improvements
that have already been made.
Pay for performance programs often target patients with serious
and complex illnesses; such patients commonly interact with
multiple healthcare providers and facilities. However, pilot
programs now underway focus on simple indicators such as
improvement in lab values or use of emergency services, avoiding
areas of complexity such as multiple complications or several
treating specialists. A
2007 study analyzing Medicare beneficiaries’ healthcare visits
showed that a median of two primary care physicians and five
specialists provide care for a single patient.
The authors doubt that pay-for-performance systems can accurately
attribute responsibility for the outcome of care for such patients.
The American College of Physicians Ethics has stated concerns about
using a limited set of clinical practice parameters to assess
quality, "especially if payment for good performance is grafted
onto the current payment system, which does not reward robust
comprehensive care...The elderly patient with multiple chronic
conditions is especially vulnerable to this unwanted effect of
Present pay-for-performance systems measure good performance based
on specified clinical measurements, such as glycohemoglobin for diabetic patients.
Healthcare providers who are monitored by such limited criteria
have a powerful incentive to deselect (dismiss or refuse
to accept) patients whose outcome measures fall below the quality
standard and therefore worsen the provider's assessment.
Patients with low health literacy, inadequate financial resources
to afford expensive medications or treatments, and ethnic groups
traditionally subject to healthcare inequities may also be
deselected by providers seeking improved performance measures.
- The Danish Act on Patient Safety
passed Parliament in June 2003, and on January 1, 2004 Denmark
became the first country to introduce nation-wide mandatory
reporting. The Act obligates frontline personnel to report adverse
events to a national reporting system. Hospital owners are
obligated to act on the reports and the National Board of Health is
obligated to communicate the learning nationally. The reporting
system is intended purely for learning and frontline personnel
cannot experience sanctions for reporting. This is stated in
Section 6 of the Danish Act on Patient Safety (as of January 1,
2007: Section 201 of the Danish Health Act): "A frontline person
who reports an adverse event cannot as a result of that report be
subjected to investigation or disciplinary action from the
employer, the Board of Health or the Court of Justice." The
reporting system and the Danish Patient Safety Database is
described in further detail in a National Board of Health
- United Kingdom
- The National Patient Safety
Agency encourages voluntary reporting of health care errors,
but has several specific instances, known as "Confidential
Enquiries", for which investigation is routinely initiated:
maternal or infant deaths, childhood deaths to age 16, deaths in
persons with mental illness, and perioperative and unexpected
medical deaths. Medical records and questionnaires are requested
from the involved clinician, and participation has been high, since
individual details are confidential.
- United States
- The 1999 Institute of Medicine (IOM) report recommended "a
nationwide mandatory reporting system … that provides for …
collection of standardized information by state governments about
adverse events that result in death or serious harm."
Professional organizations, such as the Anesthesia Patient Safety
Foundation, responded negatively: "Mandatory reporting systems
in general create incentives for individuals and institutions to
play a numbers game. If such reporting becomes linked to punitive
action or inappropriate public disclosure, there is a high risk of
driving reporting "underground", and of reinforcing the cultures of
silence and blame that many believe are at the heart of the
problems of medical error…"
- Although 23 states established mandatory reporting systems for
serious patient injuries or death by 2005, the national database
envisioned in the IOM report was delayed by the controversy over
mandatory versus voluntary reporting.
Finally in 2005, the US Congress passed the long-debated Patient
Safety and Quality Improvement Act, establishing a federal
Hospitals reports of serious patient harm are voluntary,
collected by patient safety
organizations under contract to analyze errors and recommend
improvements. The federal government serves to coordinate data
collection and maintain the national database. Reports remain
confidential, and cannot be used in liability cases. Consumer
groups have objected to the lack of transparency, claiming it
denies the public information on the safety of specific
In public surveys, a significant majority of those surveyed
believe that health care providers should be required to report all
serious medical errors publicly.
However, reviews of the medical literature show little effect of
publicly-reported performance data on patient safety or the quality
Public reporting on the quality of individual providers or
hospitals does not seem to affect selection of hospitals and
Some studies have shown that reporting performance data stimulates
quality improvement activity in hospitals.
Ethical standards of the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), the American Medical
Association (AMA) Council on Ethical and Judicial Affairs, and
the American College of
Physicians Ethics Manual require disclosure of the most serious
However, many doctors and hospitals do not report errors under the
current system because of concerns about malpractice lawsuits; this prevents
collection of information needed to find and correct the conditions
that lead to mistakes. As
of 2008, 35 US states have statutes allowing doctors and health
care providers to apologize and offer expressions of regret without
their words being used against them in court, and
have also passed laws mandating written disclosure of adverse
events and bad outcomes to patients and families.
In September 2005, US Senators Clinton and Obama introduced the
National Medical Error Disclosure and Compensation (MEDiC) Bill,
providing physicians protection from liability and a safe
environment for disclosure, as part of a program to notify and
compensate patients harmed by medical errors. It
is now the policy of several academic medical centers, including
Johns Hopkins, University of Illinois and Stanford, to promptly
disclose medical errors, offering apologies and compensation. This
national initiative, hoping to restore integrity to dealings with
patients, make it easier to learn from mistakes and avoid angry
lawsuits, was modeled after a University of Michigan Hospital
System program that has reduced the number of lawsuits against the
hospital by 75% and has decreased the average litigation cost.
The Veterans Health Administration requires the disclosure of all
adverse events to patients, even those that are not obvious.
However, as of 2008 these initiatives have only included hospitals
that are self-insured and that employ their staffs, thus limiting
the number of parties involved.
In April 2008, consumer, employer and labor organizations
announced an agreement with major physician organizations and
health insurers on principles to measure and report doctors'
performance on quality and cost.
In the United Kingdom, whistleblowing is
well recognised and is government sanctioned, as a way to protect
patients by encouraging employees to call attention to deficient
services. Health authorities are encouraged to put local policies
in place to protect whistleblowers.
Studies of patient
Numerous organizations, government branches, and private
companies conduct research studies to investigate the overall
health of patient safety in America and across the globe. Despite
the shocking and widely publicized statistics on preventable deaths
due to medical errors in America’s hospitals, the 2006 National
Healthcare Quality Report
assembled by the Agency for
Healthcare Research and Quality (AHRQ) had the following
- Most measures of Quality are improving, but the pace of change
- Quality improvement varies by setting and phase of care.
- The rate of improvement accelerated for some measures while a
few continued to show deterioration.
- Variation in heath care quality remains high.
The Health Grades study in April 2006 determined that over 3% of
hospitalized Medicare patients experienced adverse events, and that
the total number of patient safety incidents has been increasing
advocating patient safety
Several authors of the 1999 Institute of Medicine report
revisited the status of their recommendations and the state of
patient safety, five years after "To Err is Human".
Discovering that patient safety had become a frequent topic for
journalists, health care experts, and the public, it was harder to
see overall improvements on a national level. What was noteworthy
was the impact on attitudes and organizations. Few health care
professionals now doubted that preventable medical injuries were a
serious problem. The central concept of the report—that bad systems
and not bad people lead to most errors—became established in
patient safety efforts. A broad array of organizations now advance
the cause of patient safety.
"World Alliance for Patient
Safety". Organization Web Site. World Health
Organization. http://www.who.int/patientsafety/en/index.html. Retrieved
Patrick A. Palmieri, et al. (2008).
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- ^ The National Medical Error
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Presidential campaign platform but has not resubmitted the bill to
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- ^ Consumer-Purchaser Disclosure
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Principles to Guide Physician Performance Reporting (2008-04-01):
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- ^ AHRQ: 2006 National Healthcare
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- ^ HealthGrades: Third Annual Patient Safety
in American Hospitals StudyPDF (302 KiB) November 20, 2006