To Err is Human – To Delay is Deadly
Ten years later, a million lives lost, billions of dollars wasted
May 2009
To Err is Human – To Delay is Deadly
Ten years later, a million lives lost, billions of dollars wasted
Executive Summary
Ten years ago the Institute of Medicine (IOM) declared
that as many as 98,000 people die each year needlessly
because of preventable medical harm, including health
care-acquired infections (See sidebar: Preventable medical
harm). Ten years later, we don’t know if we’ve made any
real progress, and efforts to reduce the harm caused by our
medical care system are few and fragmented. With little
transparency and no public reporting (except where hard
fought state laws now require public reporting of hospital infections), scarce data does not paint a picture of real
progress.
No national entity has been empowered to coordinate
and track patient safety improvements.
Ten years after To Err is Human, we have no national entity
comprehensively tracking patient safety events or progress
in reducing medical harm and we are unable to tell if we are
any better off than we were a decade ago. While the federal
Agency for Healthcare Research and Quality attempts to
monitor progress on patient safety, its efforts fall short of
what is needed.
Doctors and other health professionals are not
expected to demonstrate competency.
There has been some piecemeal action on patient safety by
peers and purchasers, but there is no evidence that physicians, nurses, and other health care providers are any more
competent in patient safety practices than they were ten
years ago.
Based on our review of the scant evidence, we believe
that preventable medical harm still accounts for more than
100,000 deaths each year – a million lives over the past
decade. This statistic by all logic is conservative. For example, the Centers for Disease Control and Prevention
The U.S. health-care system needs nationwide mandatory,
(CDC) estimates that hospital-acquired
validated and public (MVP) reporting
infections alone kill 99,000 people each
year. This needless death is unaccept- “How much of a problem is patient of preventable health care-acquired inable, and we must demand action from safety? The unsettling fact is that no fections and medical errors. Medication errors—cited as a major problem
our health-care system.
one knows.”
by the IOM ten years ago—remain a
serious problem today. The FDA, docIn this report we give the country a fail- - Dr. Lucian Leape, March 2008
tors, hospitals, and drug manufacturers
ing grade on progress on select recmust establish better practices at every
ommendations we believe necessary
stage of the treatment process to track
to create a health-care system free of preventable medical
and
prevent
harm
from medication errors. Professional
harm.
standards regarding patient safety should ensure competent
Few hospitals have adopted well-known systems care. While some progress has been made by private initiato prevent medication errors and the FDA rarely tives and through purchasing policies, regulators have not
demanded universal competency testing for doctors and
intervenes.
While the FDA reviews new drug names for potential con- nurses.
fusion, it rarely requires name changes of existing drugs
despite high levels of documented confusion among drugs, Doctors and hospitals raise concerns that public reporting
which can result in dangerous medication errors. Comput- of medical harm will lead to frivolous lawsuits. But the
erized prescribing and dispensing systems have not been best way to prevent claims is to put systems in place to prewidely adopted by hospitals or doctors, despite evidence vent harm. Experience with public reporting in the states
demonstrates the tort concerns about such disclosures is
that they make patients safer.
overstated. With a civil justice system weakened by limA national system of accountability through ited compensation to harmed patients and inadequate overtransparency as recommended by the IOM has not sight of health care, public reporting of preventable medical harm is today perhaps the only effective accountability
been created.
While 26 states now require public reporting of some hos- measure we have.
pital-acquired infections, the medical error reporting currently in place fails to create external pressure for change. The current health reform debate presents a remarkable opIn most cases hospital-specific information is confidential portunity for improving access to health care in America
and under-reporting of errors is not curbed by systematic – but that health care should be safe. Patient safety needs to
be a major part of these reforms.
validation of the reported data.
May 2009
Page 3
Introduction
In November 1999 the Institute of Medicine (IOM) issued
the report To Err is Human, detailing a problem the public knew of only anecdotally: doctors and other health care
professionals can make mistakes. The report also revealed
something that most people didn’t know: the U.S. healthcare system wasn’t doing enough to prevent these mistakes,
and preventable medical errors were killing as many as
98,000 people a year.1 (See Sidebar: Behind the Statistics:
Real Lives).
“Medical mistakes 8th top killer” screamed the headline in
USA Today.2 “Medical Errors Blamed for Many Deaths;
As Many as 98,000 a Year in U.S. Linked to Mistakes” reported the front page of the Washington Post.3 IOM report
co-author Dr. Lucian Leape compared deaths from medical
care to three fully loaded jumbo jets crashing every-other
day, a sound-bite repeated by the New York Times editorial
board.4
“Experts Say Better Quality Controls Might Save Countless Lives. Washington, Are You Listening?” asked the LA
Times Editorial Board.5 The country certainly was. The story
was featured on three major network news shows the next
morning, and carried in three major news magazines the next
week.6 A Kaiser Family Foundation survey over the following weeks found that more than half of Americans had heard
of the IOM report and Kaiser called the report the “most
closely followed health policy story of 1999.”7
The IOM report estimated that medical errors cost the U.S.
$17-$29 billion a
year, and called for
Authors:
sweeping changes
Kevin Jewell & Lisa McGiffert
to the health-care
system to improve
Project Team:
patient safety (deConsumers Union Staff
fined by the IOM as
Suzanne Henry
“freedom from acMichael McCauley
cidental injury”8).
Daniela Nunez
The
“combined
Eric Charping
goal of the recomBetsy Imholz
mendations” said
Center for Medical Consumers
the IOM, is to “…
Arthur Levin
make errors costly
to health-care organizations and providers, so they are compelled to take action
1 Kohn LT, Corrigan JM, Donaldson M, eds. To Err Is Human: Building a Safer Health System. Washington, DC: Institute of Medicine; 1999, p. 1.
2 Davis, Bob, and Julie Appleby. “Medical mistakes 8th top killer,” USA Today, 11/30/99.
3 Weiss, Rick. “Medical Errors Blamed for Many Deaths; As Many as 98,000 a Year In U.S. Linked to
Mistakes,” The Washington Post, 11/30/99.
4 “Preventing Fatal Medical Errors,” Editorial. New York Times, 12/1/99.
5 “Hospital Error’s High Costs; Experts Say Better Quality Controls Might Save Countless Lives. Washington, Are You Listening?” Editorial. LA Times, 12/5/99.
6 Dentzer, Susan. “Media Mistakes in Coverage of the Institute of Medicine’s Error Report,” Effective
Clinical Practice, November/December 2000.
7 Kaiser/Harvard Health News Index, November/December 1999 vol.4, No.6. Kaiser Family Foundation. Internet source: http://web.archive.org/www.kff.org/content/2000/1565/HNI+Nov-Dec1999.pdf (Accessed 4/16/09).
8 Kohn, 1999, p. 58.
to improve safety.” The IOM also called for a measurable
improvement in patient safety, stating “it would be irresponsible to expect anything less
than a 50% reduction in errors Preventable
Medical
over five years.”9
Harm: The IOM defined
Within days, the Clinton administration asked a federal
task force to examine the
IOM’s
recommendations.10
The task force quickly agreed
with the majority of the
IOM’s findings.11 The IOM
report spurred seven hearings on Capitol Hill over the
following three months, and
soon at least five federal bills
were filed regarding medical
errors.12 Congress allocated
$50 million to the Agency
for Healthcare Research and
Quality (AHRQ) for patient
safety research grants in the
2001 budget, citing the IOM
report as evidence of the need
for work on the problem.13
medical error as the failure
of a planned action to be
completed as intended
(error of execution) or
the use of a wrong plan
(including failure to use a
plan) to achieve an aim
(error of planning).1 Specific
types of medical errors
highlighted in the IOM
report included error in the
administration of treatment,
failure to employ indicated
tests, and avoidable delays
in treatment.2 The IOM
agreed that many health
care-acquired
infections
(HAIs)3 are preventable,
but relegated discussion
of HAIs to an appendix of
the report. In this report we
use the term preventable
medical harm to explicitly
include both HAIs and other
medical errors.
Despite this initial flurry of
activity, progress slowed once
the media moved on to the 1 Kohn, 1999, p. 28.
next crisis. When the IOM 2 Kohn, 1999, p. 36.
While the term “healthcare associated inpublished a follow-up report in 3fections”
is used by medical professionals,
it obscures the cause-and-effect relationship
March 2001, the release bare- under discussion. For clarity we use “healthacquired infections” to refer to infections
ly registered.14 By 2004, the care
that patients contracted while interacting
with the healthcare system. Most studies and
deadline for the IOM’s goal of information about healthcare- acquired infecfocus specifically on hospital-acquired
a 50% reduction in errors, no tions
infections.
national medical error reporting bills had been passed and
the initial outrage surrounding the report had faded. Movement towards systematic change to the health-care system
remained “frustratingly slow.”15
Today our country has an opportunity for dramatic changes
to our fragmented healthcare system. Health reform to ensure that all Americans have access to high quality health
care should also include significant and active mandates to
reduce medical harm.
9 Kohn, 1999, p. 4.
10 “Clinton orders task force to seek reduction in medical errors,” CNN.com, 12/7/1999. Internet source:
http://archives.cnn.com/1999/HEALTH/12/07/medical.errors.02/index.html (Accessed 3/16/09).
11 Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, Report of the Quality Interagency Coordination Task Force, February 2000. Internet Source:
http://www.quic.gov/report/errors6.pdf (Accessed 2/27/09).
12 Kenagy, John W. and Gary C. Stein. “Naming, Labeling, and Packaging of Pharmaceuticals,” Am J
Health-Syst Pharm 58(21):3033-3041, 2001.
Shuren, Allison Weber. “Health care delivery errors: Patient safety falls prey to politics,” J Pediatr Health
Care. 15, 42-44, 2001.
13 106 Congress. “Making Omnibus Consolidated and Emergency Supplemental Appropriations for Fiscal Year 2001 Conference Report To Accompany H.R. 4577,” U.S. Washington DC: Governmental Printing Office, p. 149.
14 Millenson, M L. “Pushing the profession: how the news media turned patient safety into a priority,”
Qual. Saf. Health Care 2002;11;57-63
15 Leape, Lucian L. and Donald M Berwick. “Five Years After To Err Is Human: What Have We Learned?”
JAMA, May 18, 2005—Vol 293, No. 19.
May 2009
Page 4
Behind the Statistics: Real Lives
Lewis Blackman was 15 years old when his family brought him
to the hospital for elective surgery. The surgery was predicted
to be short, and he brought the book “Dune” to read while he
recovered. Four days later he was dead; an autopsy revealed
his abdomen was filled with almost three liters of blood and
digestive fluids from an undiagnosed perforated ulcer. The ulcer had gone undiagnosed by the doctors-in-training attending
Lewis despite indications of trouble for more than thirty hours
prior to his death. Medical experts hired by Lewis’s mother later
said that his symptoms should have suggested a routine blood
test that would have uncovered the problem.1 A failure to order
an indicated test is a medical error.2
As we reference the statistics of medical error in this report,
remember that behind each number is the life of someone like
Lewis.
One of the most widely cited statistics from To Err is Human
was the estimate that “at least 44,000 and perhaps as many
as 98,000 Americans die in hospitals each year as a result of
medical errors.”3 What does this statistic mean? Where did it
come from?
The number used by the IOM was based on two studies which
performed after-the-fact reviews of a sample of medical records (one study in New York, the other in Utah and Colorado)
to estimate the rate of preventable injuries caused by medical
management. This preventable injury rate was applied to the
33.6 million hospital admissions in the U.S. to calculate the
overall magnitude of medical errors.
The resulting 44,000 - 98,000 estimate has become one of the
most widely cited statistics on medical error, but it is not without
its critics. Several subsequent articles attacked the subjective
nature of the estimate of whether or not a patient death could
be attributed to a particular error.4
Nevertheless, defenders of the estimate focus on two reasons
that the figures are far more likely an under-estimate of the
magnitude of the problem of preventable medical harm in this
country: First, the chart review process only catches errors that
are recorded in the medical record, and evidence of many errors does not appear in the record. Second, the IOM number
accounts for only medical harm in hospitals, and much health
care is delivered outside of that setting. 5
The medical error rate used to calculate the IOM’s national estimate has also been supported by newer studies in Canada,
Australia, and other developed countries. Based on the current
state of knowledge of medical harm, two recent patient safety
textbooks estimate that 5% of hospital admissions experience
some type of adverse error, 30% of which cause consequen1 Monk, John. “How a hospital failed a boy who didn’t have to die” The State, Columbia, South
Carolina. Sunday, Jun. 16, 2002, p. A1, A internet source: http://www.lewisblackman.net/ (Accessed
4/2/09).
2 Kohn, 1999, p. 36.
3 Kohn, 1999, p. 26.
4 McDonald CJ, Weiner M, Hui SL. “Deaths due to medical errors are exaggerated in the Institute of
Medicine report.” JAMA. 2000;284:93-5.
See also: Sox HC, Woloshin S. How many deaths are due to medical error? Getting the number right.
Effective Clin Pract. 2000;6:277-283.
5 Quality of Health Care in America Committee “The Institute of Medicine Report on Medical Errors:
Misunderstanding Can Do Harm” Medscape General Medicine 2(3), 2000. 9/19/2000.
tial harm.6 This estimate implies that more than half-a-million
people in the U.S. were harmed by preventable medical errors
last year.7
Studies of specific errors also suggest the IOM report underestimates the magnitude of medical harm. Some hospital-acquired
infections were identified in the studies used by the IOM, yet
the report hardly mentions them. In an appendix to the report,
CDC statistics are given: 2 million hospital patients and 1.5 million long-term care patients are infected each year. 8 Most of
these are now believed to be preventable.9 A 2007 CDC study
estimated that 99,000 deaths in the US in 2002 were associated
with HAIs.10 The IOM study found that 7000 deaths each year
are caused by preventable medication errors.11
The lack of a reliable measurement of medical harm is a major
challenge that must be addressed. But don’t confuse the magnitude with the impact. We know the impact of the problem today.
Just ask Lewis Blackman’s family.
6 Wachter, Robert M. Understanding Patient Safety McGraw-Hill 2008, p. 10.
Vincent, Charles, Patient Safety, Elsevier, 2006, p. 42.
7 Author’s calculations. 37.1 M (US Hospital Admissions in 2007) X 10% (of which are adverse events)
X 50% (of which are preventable) X 30% (of which cause consequential harm) = 556,500
2007 US Hospital Admissions Information from “Fast Facts on US Hospitals” Internet Source: http://
www.aha.org/aha/content/2008/pdf/fast_facts_2008.pdf (Accessed 4/3/09)
8 Kohn, 1999, p. 268.
9 The CDC estimates as many as 70% are preventable: Scott, R. Douglas II, “The Direct Medical Cost of
Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention,” Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases,
Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention, March 2009,
p.7.
10 Klevens et al. “Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002,”
Public Health Reports Vol. 122 March–April 2007.
11 Kohn, 1999, p.2
Ernst, Frank R. and Amy J. Grizzle “Drug-Related Morbidity and Mortality: Updating the Cost-of-Illness
Model,” J Am Pharm Assoc 41(2):192-199, 2001.
Are we safer today than we were a decade ago? Are we doing
what is necessary to end needless suffering from preventable
medical harm? It is our search for answers to these questions
that drives this report.
The IOM recommended dozens of changes to make our
health-care system safer. In this report we evaluate how the
country has fared on select recommendations we believe
necessary to create a health-care system free of preventable
medical harm.
We evaluate progress on the following IOM recommendations:
Prevent medication errors: Make the production, regula-
tion, prescribing, and delivery of medications safer.
Create accountability through transparency: Identify
and learn from medical harm through both mandatory and
voluntary reporting systems.
Measure the problem: Establish a ‘national focus’ to track
progress on patient safety.
Page 5
Expect more: Raise standards for improvements and competency in patient safety for doctors and nurses and healthcare organizations, like hospitals.
Preventing Medication Errors
Implement safe medication practices.
To Err is Human identified medication errors, “as a substantial source of preventable error in hospitals.”16 The report recommended stronger oversight by the Food and Drug
Administration (FDA) to address safety issues connected
with drug packaging and labeling, similar named drugs, and
post marketing surveillance by doctors and pharmacists.17 In
2006 the IOM returned to the issue, publishing “Preventing Medication Errors,” a report that reiterated many of the
recommendations of the 1999 report and concluded that at
least 1.5 million preventable medication errors cause harm
in the United States each year. The 2006 report estimated
that medication errors in hospitals alone cost $3.5 billion a
year.18
Drug Confusion Errors
Medication errors include
administering or prescribing
the wrong drug, wrong dose,
or wrong route of administration to a patient. These include cases in which drugs
are provided without regard
to drug allergies or interactions with other medications
the patient may be taking. 1
1 Hicks, R.W., Becker, S.C., & Cousins, D.D.
(Eds.). (2008). MEDMARX data report. A
report on the relationship of drug names and
medication errors in response to the institute
of medicine’s call for action. Rockville, MD:
Center for the Advancement of Patient Safety,
US Pharmacopeia, Preface.
Many medication errors are
caused by the confusion
of medicines with similar
names, such as primidone (a
seizure medication) and prednisone (an anti-inflammatory
medication). For example,
the similarities of these
names led to the death of an
adolescent in California in a
case reported in 2004, despite
the fact that the potential for
primidone-prednisone confusion had been identified
three years earlier. 19,20 The
confusion continues. A 2008
report listed Prednisone as
commonly confused with 12
other drugs 21
Packaging and design can also contribute to drug confusion
errors. In a high profile case in 2007 the twin babies of actor Dennis Quaid and his wife were given 1,000 times the
prescribed dose of the blood thinner heparin. According to
Quaid’s testimony before Congress, the couple sued the drug
manufacturer, charging that the manufacturer was negligent
in packaging different doses of the product in similar vials
with similar blue labels.22 The court dismissed the case on
jurisdictional grounds and it is now on appeal. This problem was not new. A year before, a similar mix-up ocurred
when six infants in a newborn intensive care unit at an Indianapolis hospital were given excessive doses of heparin,
leading to the death of three of them, and two infants at the
same Indianapolis hospital had received a similar overdose
in 2001.23 After the Indianapolis deaths, the manufacturer issued a letter warning hospitals of the potential for confusion,
but the packaging was not changed for at least 12 months
and the same packaging was still being used in the hospital
treating the Quaid children.24 After the Quaids threatened to
sue the hospital where their twins were treated, the hospital
agreed to pay the family $750,000 and invested $100 million
in new technology to prevent similar harm in the future.25
Regulators fined the hospital for failure to follow its own
safety policies.26
Most victims of medication error do not have the same ability to drive media attention and prompt action. There were
25,530 look-alike and/or sound-alike drug confusion errors
reported to two drug error reporting systems in the four years
2003-2006; drug labeling and packaging contributed to 7.8%
of look-alike and/or sound-alike errors.27 With a problem of
this magnitude, we need a systematic solution to address all
of the confusion errors, not just the few that get media attention.
The FDA has tested new drugs for potential name confusion
since 1999 and monitors the market for instances of confusion, but few existing names are changed.28 In an unusual action in 2005 the FDA called for the Alzheimer’s drug Reminyl to be renamed after confusion with the diabetes drug
Amaryl was implicated in two patient deaths. Reminyl was
renamed Razadyne.29
The current statistics on look-alike/sound-alike error demonstrates that the FDA’s effort is inadequate. The FDA is conducting a pilot program to expand pre-market drug testing to
include name confusion evaluation by third parties, but the
22 Ornstein, Charles “Dennis Quaid files suit over drug mishap” Los Angeles Times 12/5/2007.
Testimony of Dennis Quaid and Kimberly Quaid Before the Committee on Oversight and Government
Reform of the United States House of Representatives, May 14, 2008; http://oversight.house.gov/documents/20080514103204.pdf.
23 Martin, Deanna “3rd Ind. preemie infant dies of overdose” Associated Press 9/20/2006 Internet Source:
http://www.boston.com/news/nation/articles/2006/09/20/3rd_baby_dies_from_drug_overdose_in_ind/
(Accessed 4/15/09)
Testimony of Dennis Quaid and Kimberly Quaid, 2008, p. 4.
24 Deutsch, Jonathan “IMPORTANT MEDICATION SAFETY ALERT BAXTER HEPARIN SODIUM
INJECTION 10,000 UNITS/ML AND HEP-LOCK U/P 10 UNITS/ML” Dear Healthcare Provider Letter, Baxter. 2/6/2007. Internet Source: http://www.fda.gov/medwatch/safety/2007/heparin_DHCP_02-062007.pdf (Accessed 4/15/09)
25 Lin, Rong-gong “Dennis Quaid says ‘time is running short,’ is considering suing Cedars-Sinai” LA
Times. 3/28/08 Internet Source: http://articles.latimes.com/2008/mar/28/local/me-quaid28 (Accessed
4/15/09)
“Dennis Quaid’s Medical Nightmare,” The Oprah Winfrey Show. 2/19/2009. Internet Source: http://www.
oprah.com/slideshow/oprahshow/20090219-tows-dennis-quaid/5 (Accessed 4/12/09).
“Dennis & Kimberly Quaid Agree To $750,000 Settlement From Cedars Sinai Medical Center,” December 15, 2008; http://www.accesshollywood.com/dennis-and-kimberly-quaid-agree-to-750000-settlementfrom-cedars-sinai-medical-center_article_12649. (Accessed 5/8/09)
16 Kohn, 1999, p. 182.
17 Kohn, 1999, p. 136.
18 Aspden P, Wolcott J, Bootman JL, Cronenwett LR (eds), Committee on Identifying and Preventing
Medication Errors: Preventing Medication Errors: Quality Chasm Series. Institute of Medicine of the
National Academies. Washington, National Academy Press, 2006, pp. 112, 117.
26 “Quaid Hospital Case Closed,” World Entertainment News Network, 1/9/09.
19 Pestaner, JP “Fatal mix-up between prednisone and primidone.” Am J Health Syst Pharm. 2004 Aug
1;61(15):1552.
28 Holquist, Carol “How FDA reviews drug names” Drug Topics. 4/2/2001. Internet Source: http://www.
fda.gov/CDER/drug/MedErrors/reviewDrugNames.pdf (Accessed 4/14/2009)
20 “Use Caution—Avoid Confusion” USP Qual Rev. No. 76, March 2001.
Cohen, Robert, Newhouse news, “What’s in a name,” 8/11/08.
21 Hicks, 2008, p. 186
29 Associated Press “J&J changes Alzheimer’s drug name to avoid confusion” April 11, 2005.
27 Hicks, 2008, pp. 179, 193.
May 2009
Page 6
pilot program won’t be finished until 2011, 12 years after the
original IOM report highlighted the problem.30 In addition,
this FDA effort doesn’t address the problem of look-alike/
sound-alike drugs already
on the market.
Are they Watching?
We may all have the best
of intentions, but knowing
we’re being watched makes a
difference in our actions. At the
beginning of a study of ICU staff
at an Australian hospital, only
12.4% of patient contacts were
preceded by a hand washing.
When informed that their hand
washing was being monitored
and group hand-washing rates
were posted in the ICU, hand
washing occurred prior to 68.3%
of patient contacts, a more than
five-fold improvement. 1
Consumers Union believes the FDA should
use its authority to rigorously set and enforce
the naming, labeling,
and packaging standards
necessary to reduce drug
confusion errors among
new and existing drugs.
Another means to reduce
drug confusion errors is
the use of technologies
such as Computerized
Physician Order EnPublishing the hand washing
try (CPOE) systems to
rates of individual doctors
write prescriptions and
would likely have stimulated
Bar-Code
Medication
even greater improvement. A
Administration
(BCMA)
study of Wisconsin hospitals
technology
to
check
that
found that hospitals subject to
patients
get
the
right
medpublicly reported facility-specific
ication. Both technoloquality measures put more
gies are estimated to cut
effort into quality improvement
activities
than
hospitals
medication errors in half
receiving confidential reports
or more.31 CPOE systems
on their quality measures. This
can identify and warn
was especially true for lowprescribing physicians of
performing hospitals.2
medication allergies or
interactions, remove the
1 Tibballs, James “Teaching hospital medical staff
challenge of handwritto handwash” Medical Journal of Australia. April
1996. Internet Source: http://www.mja.com.au/
ten records, and provide
public/issues/apr1/tibballs/tibball.html (Accessed
3/14/09).
decision support on stan2 Hibbard, Judith H., Jean Stockard, and Martin
dardized dosing.32 CPOE
Tusler “Does Publicizing Hospital Performance
Stimulate Quality Improvement Efforts? Results
systems can be electronifrom a study in Wisconsin suggest that making performance information public stimulates quality imcally linked to pharmaprovement.” Health Affairs Vol. 22, No. 2. March/
April 2003.
cies to directly transmit
prescriptions, a process
called “e-prescribing.”33
E-prescribing systems can be used by individual doctors in
outpatient settings as well as those working within a hospital
system.
A 2008 survey of American Hospital Association
members found that only 17% had a CPOE system in place
and operational in all units of the hospital. Another 38% had
partially operational systems or plans for systems, but al30 Department of Health and Human Services Food and Drug Administration “Pilot Program To Evaluate
Proposed Name Submissions; Concept Paper” Federal Register Vol. 73, No. 195. October 7, 2008.
31 Kohn, 1999, p. 191.
Poon et al. “Medication Dispensing Errors and Potential Adverse Drug Events before and after Implementing Bar Code Technology in the Pharmacy” Annals of Internal Medicine 9/19/2006 Vol. 145, NO.6, pp.
426-434.
32 Wachter, Robert M. Understanding Patient Safety Lange. 2008, pp. 139-140.
33 Virk, Pushwaz et al.”Analyzing Transaction Workflows in an ePrescribing System” AMIA 2006 Symposium Proceedings, p.– 1129.
most half (45%) of respondents had no plans to implement a
CPOE system.34 The IOM called for all health-care providers to be using e-prescribing by 2010.35 A federal law passed
in 2008 offers bonus Medicare payments to physicians who
use e-prescribing beginning this year. Doctors not using eprescribing will face reductions in Medicare payments in
2012.36
While technology such as e-prescribing and bar-coding are
not a panacea for medication errors, they hold promise to
improve medication safety. The 2009 economic stimulus bill
provided $19.2 billion for health information technology,
which may encourage adoption of such systems.37
Drug Error Reporting Systems
Several voluntary reporting systems collect information on
patient harm from medication, including FDA MedWatch,
the ISMP Medication Errors Reporting Program (ISMPMERP), and Quantros MEDMARX. While useful for learning about medication errors, some researchers believe that
fewer than 1 in 100 are reported to these voluntary systems.38
Although some state adverse event reporting laws include
medication errors, no national system suitable for tracking
progress on medication errors exists.
In 2008, Bruce Lambert, a Professor at the University of Illinois at Chicago, commented:
“Despite all the focus on prevention, there is little evidence of large-scale improvement in the wrong-drug error
rate. We are not suggesting that no one has been successful at minimizing these errors, it is just that few have been
able to demonstrate convincing evidence of success, especially on a national scale. ... This represents a serious gap
in current knowledge about medication safety. The lack of
a valid, reliable, and efficient method for detecting name
confusion errors is the main reason for this gap in our
knowledge. It is a fundamental principle of quality control that if a process cannot be measured, it cannot be
improved.” [Emphasis added] 39
The bolded quote sums up a fundamental tenet of this report.
As with other preventable medical harm, the lack of a mandatory, validated, and public (MVP) reporting system leaves
us in the dark on whether or not we are making meaningful
progress in eliminating preventable medication errors. (The
concept of MVP reporting systems are discussed in more detail below.)
34 Jha AK et al. “Use of Electronic Health Records in U.S. Hospitals.” N Engl J Med. 2009 Mar 25
35 Aspden, 2006, p. 211
36 Park, Carolyne. “Rx by computer moving to state Plan created to cut errors, costs.” Arkansas Democrat-Gazette 8/4/08
37 Robert Steinbrook, M.D. “Health Care and the American Recovery and Reinvestment Act,” N Engl J
Med. Vol. 360 n.11 pp. 1057-1060 3/12/2009
38 Hicks, 2008, p. 12.
39 Hicks, 2008, pp. 11-12.
Page 7
Hospital Acquired Infection Reporting Systems:
Recently passed state hospital infection disclosure laws will
increase public accountability on Healthcare Acquired Infections
(HAIs). Some 26 states now have mandatory reporting systems
for HAIs.1 All of these states require public disclosure of
hospital-specific rates of select HAIs, and 12 state laws require
systems to validate the data for accuracy.2 Nebraska, Nevada,
and Arkansas have passed laws that require hospitals to report
infection data to state agencies, but this information is not
disclosed to the public.3
Preliminary evidence in Pennsylvania – the only state reporting
on all types of HAIs - shows public reporting is an effective tool
for reducing infections: Pennsylvania’s overall infection rate
decreased by eight percent following two consecutive years of
reporting comparable infection data.
Each state has established its own reporting program, although
most are collecting data on similar types of infections via the
CDC’s National Healthcare Safety Network (NHSN), essentially
creating a national standard for collecting information on this
type of medical harm.4,5
While much work remains, progress towards a National MVP
(Mandatory, Validated, and Public at the facility level) reporting
system for HAIs is underway.
1 “Reporting of Hospital Infection Rates,” Consumers Union, October 2008. Internet Source: http://
www.consumersunion.org/campaigns/Map_SHI_state_laws_10-08.pdf. (Accessed 3/27/09)
2 Validating states: CO, FL, IL, NY, NH, OH, OR, PA, RI, SC, TX, VT. Other states may be attempting
to validate the data, but their laws do not specifically call for it.
3 “Summary of State Laws on Hospital-Acquired Infections,” Consumers Union, October 2008. Internet Source: http://www.consumersunion.org/campaigns/CU%20Summ%20of%20HAI%20state%20
rpting%20laws%20as%20of%2010-08.pdf
4 Besser, Richard E., “CDC’s role in Preventing Healthcare Associated Infections,” Testimony before
the US House Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, 4/1/09, p. 3. http://appropriations.house.gov/Witness_testimony/LHHS/
Richard_Besser_04_01_09.pdf. (Accessed 4/12/09)
Stricof, Rachel, “New York State Approach to Health care Associated Infection Surveillance, Prevention,
and Public Reporting,” p. 3, Testimony before the US House Appropriations Committee, Subcommittee
on Labor, Health and Human Services, Education, and Related Agencies, http://appropriations.house.
gov/Witness_testimony/LHHS/Rachel_Stricof_04_01_09.pdf. (Accessed 4/12/09)
5 GAO, “Health-Care-Associated Infections in Hospitals: An Overview of State Reporting Programs
and Individual Hospital Initiatives to Reduce Certain Infections,” GAO-08-808 (Washington, D.C.: Sept.
2008), pp. 1, 11
.
Prevent Medication Errors - Conclusion
Progress on medication errors falls short of the IOM’s vision. While the FDA reviews new drug names for potential
confusion, high levels of error remain. Electronic prescribing systems have not been widely adopted, and no national
reporting system for medication mistakes at the facility level
exists that is Mandatory, Validated, and Public.
Create
Accountability
Transparency
Through
torious “doctor scribble” problem). The other cuts costs by
buying cheap ballpoint pens that smudge during prescription
writing, leaving the orders illegible and doubling the rate of
dispensing errors. Do you want to know which hospital is
which?
You are not alone. Ninety-two percent of Americans believe
that hospitals should be required to report serious medical
errors, and 63% believe the reports should be public.40 The
IOM specifically recommended public reporting of harmful
medical errors so that the public could hold local health-care
systems (such as hospitals) accountable and encourage improvement.
The IOM panel recommended two separate national reporting systems: A mandatory and public reporting system designed to encourage accountability, (i.e. creating external
pressure for change) and a voluntary and confidential system
designed to facilitate learning about errors.41
Progress on reporting since 1999 has been almost entirely
focused on voluntary, confidential, or aggregate reporting
systems designed to facilitate learning about errors. Seventeen states had established confidential reporting systems by
the time a federal framework for such “learning” systems
was created in the Patient Safety and Quality Improvement
Act of 2005. 42 This law prohibits the release of information
about medical harm collected by Patient Safety Organizations (PSOs) and shields hospitals that report harm.43 Finally
implemented in 2008, any information collected by PSOs
will not be publicly disclosed by hospital or health-care facility. Under this system hospitals can learn from their mistakes, but you can’t.
The PSO system joins a reporting world crowded with confidential, learning-oriented systems. The Joint Commission
(a private membership and accreditation body) collects information on certain errors causing serious injury or death
in its Sentinel Event Database; the reports are voluntary and
the information collected remains confidential.44 Over 13
years this database has only received 113 reports of serious
hospital-acquired infections, which CDC studies estimate
claim almost 99,000 lives each year.45 The electronic Patient
Safety Reporting System was developed for Veterans Administration facilities. The identities of health-care facilities
reporting to the system are confidential and it is operated
40 The Kaiser Family Foundation/Agency for Healthcare Research and Quality/Harvard School of Public Health “National Survey on Consumers’ Experiences With Patient Safety and Quality Information”
November 2004.
41 Kohn, 1999, pp. 86-89.
42 CT, FL, GA, KS, MD, ME, NJ, NV, OH, OR, PA, RI, SC, SD, TN, UT, WA.
Rosenthal, Jill and Mary Takach. “2007 Guide to State Adverse Event Reporting Systems,” The National
Academy for State Health Policy. December 2007.
Identify and learn from preventable medical harm
through both mandatory and voluntary reporting systems.
43 “President Signs Patient Safety and Quality Improvement Act of 2005” Press Release. 7/29/2005.
Internet Source: http://georgewbush-whitehouse.archives.gov/news/releases/2005/07/20050729.html (Accessed 3/16/09).
AHRQ website: http://www.pso.ahrq.gov/regulations/regulations.htm; Patient Safety and Quality Improvement Act of 2005, Public Law 109-41 109th Congress, http://www.pso.ahrq.gov/statute/pl109-41.
htm. (Accessed 5/13/09)
44 The Joint Commission. “Sentinel Event Policy and Procedures” July 2007, pp. 1, 6, 7.
Imagine two hospitals in your town. One slashed medication errors in half by investing in a computerized system to
assist doctors with prescription writing (eliminating the no-
45 The Joint Commission. “Sentinel Event Statistics as of: December 31, 2008,” Internet Source: http://
www.jointcommission.org/NR/rdonlyres/241CD6F3-6EF0-4E9C-90AD-7FEAE5EDCEA5/0/SE_
Stats12_08.pdf (Accessed 4/12/2009)
Klevens, 2007.
May 2009
Page 8
46
external to the Veterans Administration (by NASA). These
two systems mirror the internal secret systems operated by
most hospitals; a recent survey indicates that 98% of hospitals operate some type of internal reporting system for medical harm.47 The voluntary, confidential nature of these systems prevents assessment of whether they have any impact
on the safety of patients.
The National Quality Forum (NQF) is a private membership
group that works to set “national priorities and goals for performance improvement,” and publishes a list of voluntary
consensus standards related to patient safety.48 In 2002 the
NQF endorsed a list of medical events that should “never
occur.” This list, now formally called the list of “serious reportable events” is often referred to as the “Never Event”
list. The list currently contains 28 serious medical errors.49
State reporting systems based on this list cover only a small
subset of preventable medical harm.
A national mandatory and public reporting system facilitating public accountability does not exist, although fragmented progress has been made at the state level. As of October
2007, 25 States and the District of Columbia operated some
type of medical error reporting system. Almost half of these
states use a variation of the “Never Event” list to determine
what type of medical harm must be reported.50
Of the 26 mandatory medical error reporting systems, to
date, only four publicly report facility-specific information
on their websites.51 Facility specific reporting is essential
to facilitating accountability, and when this report uses the
term “public” reporting, we refer to facility-specific reporting. Consider if Consumer Reports tested 50 cars and found
some performed well and others unsafe, but refused to reveal
which cars were which. The public would not be served by
such evaluation. Error information is not useful unless it is
publicly tied to the entity where the harm occurred.
Minnesota is one state that publishes facility-specific information about patient harm on a state Minnesota Department
of Health website.52 Seventy-two percent of Minnesota facilities surveyed in 2008 felt that the Minnesota error reporting law made them safer than they had been when reporting
began in 2003. One respondent said, “(Our) focus was always on patient safety, however now safety efforts are better
46 Patient Safety Reporting System Website. “Program Overview,” Internet Source: http://www.psrs.arc.
nasa.gov/flashsite/programoverview/index.html (Accessed 4/5/09)
47 Farley et al.”Adverse-event-reporting practices by US hospitals: results of a national survey,” Qual.
Saf. Health Care 2008;17;416-423. (Author’s calculation of weighted average of critical access and noncritical access respondents.)
understood by more of our staff and we prioritize this work
ahead of other work. Data is helping us to create more sense
of urgency for this work.” 53
The magnitude of certain events reported to the Minnesota
system is on the low end of what would be expected from
national estimates of the incidence of medical harm. For
example, only one death and five significant disabilities resulting from medication errors in hospitals were reported in
the 2008-reporting year. This may reflect underreporting to
the system. Minnesota health officials do not perform regular audits to validate the reporting level, although they do
compare event reports to death records and consumer complaints.54 Without validation, diligent reporters may appear
to perform more poorly than their peers who simply fail to
report at all. More than half of states with reporting systems
acknowledged that underreporting occurs in their system.55
Validation, generally through random chart audits or regular
comparison to claims and billing data, counters systematic
underreporting by participants. As of January 2008, only
three states reported performing on-site audits to validate
compliance. (Sixteen states reported using more limited
validation techniques.)56 Validation programs must be active, ongoing and funded to be effective. The New York City
Comptroller recently reported that the state was not sufficiently enforcing or funding its reporting system, stating the
ability of the state program “to more broadly improve the
quality of care and reduce unnecessary costs has been seriously compromised” by these shortcomings.57
We do not have national reporting systems with the three elements needed for accountability: Mandatory, Validated, and
Public at the facility level (MVP). MVP reporting systems
are needed to create the external pressure needed to create
systemic change. (See sidebar: HAI Reporting Systems)
MVP reporting would represent a sea-change in a health-care
system accustomed to hiding errors.58 Only 14% of doctors
support public reporting of medical errors.59 Shortly after
the IOM report, the New York Times reported that both the
American Medical Association and the American Hospital
Association “vehemently opposed mandatory reporting of
errors.”60 Much of this resistance is driven by concerns that
public reporting would lead to frivolous lawsuits.
The best way to prevent negligence claims is to put systems
in place to prevent medical harm. Legal claims are filed on
behalf of a small fraction of patients who sustain
48 National Quality Forum “Mission – About - National Quality Forum,” Internet Site: http://www.qualityforum.org/about/mission.asp (accessed 3/16/09).
The National Quality Forum “Safe Practices for Better Healthcare,” 2009. Internet Source: http://www.
qualityforum.org/projects/ongoing/safe-practices/ (Accessed 4/20/09).
49 “National Quality Forum Updates Endorsement of Serious Reportable Events in Healthcare,” Press
Release. National Quality Forum. 10/16/2006 Internet Source: http://www.qualityforum.org/pdf/news/
prSeriousReportableEvents10-15-06.pdf (Accessed 3/31/09)
50 Rosenthal, Jill and Mary Takach. “2007 Guide to State Adverse Event Reporting Systems,” The National Academy for State Health Policy. December 2007, p. 1.
51 NY, MN, MA, IN. See http://www.safepatientproject.org/2009/05/state_medical_error_report_lin.
html
Rosenthal, Jill and Mary Takach. “2007 Guide to State Adverse Event Reporting Systems,” The National
Academy for State Health Policy. December 2007.
52 Minnesota Dept. of Health “Patient Safety - Minnesota Dept. of Health” Internet Source: http://www.
health.state.mn.us/patientsafety/ (Accessed 3/16/09).
53 “Adverse Health Care Events Reporting System: What have we learned? 5-YEAR REVIEW,” Minnesota Dept. of Health. January 2009. pp. 2, 9.
54 Lisa McGiffert interview with Diane Rydrych, MN Department of Health. 4/14/09.
55 “Adverse Events In Hospitals: State Reporting Systems,” The Office of Inspector General of the Department of Health and Human Services. December 2008, pp. 12-13.
56 “Adverse Events In Hospitals: State Reporting Systems,” 2008, pp. 12-13.
57 “The High Cost of Weak Compliance With the New York State Hospital Adverse Event Reporting and
Tracking System” Office of New York City Comptroller. 2009, pp. 27-29.
58 Gibson, Rosemary, and Singh, Janardan Prasad, Wall of Silence, 2003, pp. 136-138.
59 Blendon, Robert J., et al. “Views of Practicing Physicians and the Public on Medical Errors” New
England Journal of Medicine. Volume 347:1933-1940, 12/12/2002 Number 24.
60 Pear, Robert “Clinton to Order Steps to Reduce Medical Mistakes,” The New York Times 2/22/2000.
Page 9
injury through medical negligence. Of those filed, many do
not result in an award.61 Thus the legal system compensates
patients for a miniscule portion of the injury sustained, and
at tremendous personal cost. While physician and hospital
resistance has slowed adoption of the IOM accountability reporting recommendations, experience with reporting lowers
this resistance. A survey of hospital officers found that those
in states with mandatory reporting systems were three times
more likely to support facility-specific public reporting than
hospitals without experience with mandatory reporting.62
Today, many states have passed tort reform laws that significantly increase the burden on people who have been harmed
by medical care and protect doctors from suits over all but
the most egregious behaviors.63 With such a weakened civil
justice system, and a weak and inadequate administrative
oversight system in most states, public reporting of preventable medical harm – and the embarrassment that might accompany the public release of poor results – is today perhaps
the only accountability measure we have that is both effective and reliable.
MVP reporting systems are necessary to hold all health-care
facilities equally accountable for patient safety. Consumers
Union recommends mandatory validated and public reporting of preventable medical harm (health care-acquired infections and medical errors), at the state and national level.
Accountability through Transparency - Conclusion
While a network of hospital-acquired infection disclosure
systems is beginning to emerge, the scope of these only
covers a small portion of the HAIs occurring. Medical error
reporting systems currently in place fail to create external
pressure for change. Most states do not publicly report facility-specific errors and many do not include a validation requirement. Twenty-four states do not have any medical error
reporting requirements in place and 24 states do not require
HAI reporting. The federal Patient Safety and Quality Improvement Act of 2005 is voluntary and keeps the medical
error information gathered by Patient Safety Organizations
confidential, thereby removing a key incentive for safety improvement.
Measure the Problem
Establish a ‘national focus’ to track progress on patient
safety.
When products are connected with deaths, we investigate
whether there are changes in them that might prevent accidents in the first place or minimize the harm from accidents when they happen. The seat belt, the child car seat, and
many technical innovations were engineered into cars, for
61 Studdert, David M. et al “Claims, Errors, and Compensation Payments in Medical Malpractice Litigation” N Engl J Med May 2006;354:2024-33.
62 Weissman et al, “Error Reporting and Disclosure Systems: Views From Hospital Leaders,” JAMA.
2005;293(11):1359-1366.
63 American Tort Reform Association, Medical Liability Reform,
php?issue=7338. (Accessed 5/11/09)
http://www.atra.org/issues/index.
Public Citizen, “The Inequitable Impact Of Non-Economic Damage Caps: Three Academic Studies Demonstrate Severely Injured and Female Patients Are Hurt the Most,” 2005.
example, based on this approach to accident prevention. Today, a car’s National Highway Traffic Safety Administration
“safety rating” is a key characteristic that buyers examine
before they lay down their money. Health care has enjoyed
no such national safety review.
“There is no cohesive effort to improve safety in health
care,” lamented the IOM in 1999.64 The report stressed that
the fundamental problem was not that individual doctors
made errors. The fundamental problem was the failure of the
health-care system to monitor these errors, anticipate them,
and minimize the harm to patients. This failure, the IOM
noted, required a national focus on fixing the health-care system, not just the errors of individual practitioners. The IOM
recommended creation of a Center for Patient Safety within
the federal Agency for Healthcare Research and Quality
(AHRQ).65
A Simple Checklist.
Consider the case study of one common type of medical
harm — preventable bloodstream infections. In early 2004,
researchers measured catheter-associated infections across
a set of Michigan-affiliated Intensive Care Units (ICUs)
and found 7.7 bloodstream infections occurred for every 1000 days of catheter use. A statewide safety initiative
called “Michigan Health and Hospital Association (MHA)
Keystone: ICU” set a goal of reducing catheter-associated
bloodstream infections. Inspired by and coordinated with
the successful research of Dr. Peter Pronovost and others
at Johns Hopkins, MHA Keystone instituted a short checklist of best-practices related to catheter use and empowered
nurses to ensure that doctors were following those practices.
The initiative then tracked catheter-associated bloodstream
infection rates in 103 participating ICUs.66
The overall results were stunning. Bloodstream infections
across the participating ICUs dropped to 1.4 per 1000 days
of catheter use, less than 20% of the rate prior to implementation of the checklist and double-checking procedures.67
MHA Keystone estimates that the initiative saved nearly
1,800 lives over four years.68
While the aggregate results were impressive, results were
mixed across facilities. A year and a half after the study began, MHA reported at least 50% of the participating ICUs
had completely eradicated catheter-associated bloodstream
infections. A quarter of the ICUs, however, still had infection rates of 2.4 per 1000 days or higher.69 Unfortunately,
MHA Keystone does not identify which facilities lagged
64 Kohn, 1999, p.75.
65 Kohn, 1999, p. 9.
66 Pronovost P, Needham D, Berenholtz S, Sinopoli D, Haitao C, Cosgrove S, et al. An intervention to
decrease catheter-related bloodstream infections in the ICU. N Engl J Med 2006;355:2725-32. Internet
Source: http://content.nejm.org/cgi/content/full/355/26/2725. (Accessed 4/16/09)
Berenholtz SM, Pronovost PJ, Lipsett PA, et al. Eliminating catheter-related bloodstream infections in the
intensive care unit. Crit Care Med 2004;32:2014-2020.
67 Author’s calculations. 1.4/7.7 = 18%. Note that the hospitals used as a starting benchmark were a subset
of the hospitals in the MHA Keystone project.
68 2008 Annual Report. MHA Keystone Center for Patient Safety and Quality, p. 6; four-year estimate
was for 2004-2008.
69 Pronovost, 2006, p. 2730.
May 2009
Page 10
behind, preventing the public from discerning the hospitals
with zero bloodstream infections from the ones without significant progress.
While the MHA Keystone: ICU initiative was not an MVP
program as envisioned by this report, the results were widely
reported and the process changes instituted by Keystone are
now the focus of several national initiatives.70 Dr. Pronovost
won a MacArthur genius award for his work.71 The project
was recognized as a success in part because it measured the
impact of its work. Without evidence of improvement, the
initiative’s changes may not have been continued by the participating ICUs, let alone spurred a national movement to
adopt the process changes.
This is one local example of the type of focus the IOM envisioned at the national level. The panel recommended creation of an agency that would be a ‘national focal point’ on
safety in health care, much the way MHA Keystone: ICU
was a focal point for bloodstream infections in Michigan.
This agency would research and promote best-practices for
patient safety and, crucially, track and report our nation’s
progress towards ending preventable medical harm.
Tracking National Progress.
The AHRQ is the closest federal agency to the IOM’s vision of a “Center for Patient Safety” coordinating national
resources on patient safety.72 AHRQ is charged with enhancing “the quality, appropriateness, effectiveness of health services” in the U.S. It funds numerous research projects on
quality and safety and publishes the “National Healthcare
Quality Report,” (NHQR) to discuss and quantify progress
on patient safety. 73
The NHQR estimates national progress on patient safety
primarily through claims data on patients in the Medicare
system, hospital billing data from the states, and various
other sources like vital statistics and census data.74 It discloses no provider or facility-specific information – all data
is presented in the national or state aggregate. The agency’s
Patient Safety Indicators focus attention mostly on surgical
errors, and does not use data contained in less accessible
forms (such as patient charts). 75 The data is also stale; the
2008 report (published in 2009) discusses patient safety
data only through 2006. Such delays are a chronic problem
with health data and reduce the relevance of the report as a
70 Brody, Jane. E. “A Basic Hospital To-Do List Saves Lives,” The New York Times. January 22, 2008.
Internet Source: http://www.nytimes.com/2008/01/22/health/22brod.html (Accessed 4/16/09)
“AHRQ Awards $3 Million To Help Reduce Central Line-Associated Bloodstream Infections in Hospital
ICUs,” Press Release, October 1, 2008. Agency for Healthcare Research and Quality, Rockville, MD.
Internet Source: http://www.ahrq.gov/news/press/pr2008/clabipr.htm (Accessed 4/12/09)
71 “2008 MacArthur Fellows: Peter Pronovost,” MacArthur Foundation Website. Internet Source: http://
www.macfound.org/fellows/2008/pronovost (Accessed 4/15/09)
feedback mechanism. Widespread adoption of health information technology would allow more timely and accurate
information from clinical records. In the meantime, much
can be gleaned from claims data and hospitals should be held
accountable for ensuring the data is accurate. The lack of
timely, facility-specific information also limits its use as a
tool for consumers in making health care decisions.
The 2008 NHQR report estimates that patient safety declined
by almost 1% a year over the six years after the IOM report,
but states “[d]ata remain incomplete for a comprehensive
national assessment of patient safety.” In what is an indicator
of how little progress has been made towards accounting for
preventable medical harm, the latest AHRQ report still uses
the IOM’s 1999 work as the best estimate of the magnitude
of medical errors.76
Without comprehensive measures of progress, we can’t say
if the indicators examined by the NHQR data accurately
represent the state of patient safety as a whole. While 17
of the 38 indicators tracked by AHRQ have declined somewhat over the last six years, in some areas not referenced by
NHQR, there is evidence that patient safety is getting rapidly, not slowly, worse.77 For example, the number of hospital
discharges with Clostridium difficile-associated infections,
which are primarily regarded as health care-acquired infections, more than doubled from 2001 to 2005.78
The 1999 IOM report contemplated tracking national progress on patient safety through a periodic survey of medical
records, following the methods of the academic research that
provided the basis for the IOM’s original estimate 44,00098,000 annual deaths from medical errors.79 Such a periodic national survey has not been implemented and may
be impractical, although the adoption of electronic medical
records may make such a survey less costly and less labor
intensive.
A national MVP reporting system on preventable medical
harm would be able to fill the measurement role of a national
survey. Variations in current reporting in voluntary systems
may be due to changes in reporting compliance rather than
changes in error rates; validation of mandatory systems
minimizes such variation. A national MVP reporting system
would have the additional benefit of tracking progress at the
local, as well as national, level. As discussed above, such a
system does not yet exist.
Measure the Problem - Conclusion
Ten years after To Err is Human, we have no national entity
comprehensively tracking patient safety and we are unable
72 Kohn, 1999, pp. 78-79.
73 US Code Title 42. CHAPTER 6A, SUBCHAPTER VII, Part A,§ 299. Internet Source: http://www4.
law.cornell.edu/uscode/42/usc_sec_42_00000299----000-.html (accessed 3/16/09).
Agency for Healthcare Research and Quality website. “2007 National Healthcare Quality & Disparities
Reports” Internet Source: http://www.ahrq.gov/qual/qrdr07.htm (Accessed 3/16/09).
74 AHRQ website, NHRQ State Snapshots, Interpretation of Results, Examination of data sources,
http://statesnapshots.ahrq.gov/snaps07/interpretation.jsp?menuId=39&state=ID#examination (Accessed
5/11/09)
75 AHRQ Quality Indicators – Guide to Patient Safety Indicators. Rockville, MD: Agency for Healthcare
Research and Quality, 2003. Version 2.1, Revision 2, (October 22, 2004). AHRQ Pub.03-R203. p. 23.
76 Agency for Healthcare Research and Quality. “2008 National Healthcare Quality Report.” Rockville,
MD: U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality; May
2009. AHRQ Pub. No. 09-0001, pp. 8-9, 101.
77 AHRQ, May 2009, p. 9.
78 Elixhauser, Anne and Michael Jhung. “Clostridium Difficile-Associated Disease in U.S. Hospitals,
1993–2005” Healthcare Cost and Utilization Project Statistical Brief #50. April 2008
79 Kohn, 1999, p. 83.
Page 11
to tell if we are any better off than we were a decade ago.
AHRQ is attempting to do this. But without the comprehensive breadth needed to assess the problem, it falls short of
what is needed.
National Quality Forum (NQF), such as surgeries performed
on the wrong patient or part of a body and blood transfusions
with the wrong blood type.83
Raise standards for competency in patient safety for
health-care professionals (like doctors and nurses) and
health-care organizations (like hospitals).
Medicare’s no pay policy has increased pressure for accountability, and given some time could have a significant impact
on Medicare patients and costs. Numerous states and private
health plans are following suit by adopting similar no pay
policies for some or all of the Medicare and NQF preventable adverse events.84
Professional standards in health care are set by government
agencies, purchasers, and professional peer groups. In 1999,
the IOM recommended a greater focus on patient safety by
regulators, accreditors and purchasers. The report called for
periodic examinations of doctors and nurses to assess “both
competence and knowledge of safety practices.”80 Over the
past ten years, efforts to improve competency in patient
safety standards have come mostly from the private sector.
These efforts are laudable, but results are fragmented and no
systematic process exists to promote and measure national
improvement.
A similar, but private, effort to use purchaser power to improve patient safety began shortly after the publication of To
Err is Human. Several large employers formed The Leapfrog Group, which now includes many of the nation’s largest
corporations and some public agencies. The group agreed
“to base their purchase of health care on principles that encourage quality improvement among providers.”85 Leapfrog
publishes annual surveys rating the compliance of responding hospitals with specific quality and safety standards, and
uses the collective purchasing leverage of its members to
stimulate improved quality and safety.86
Fragmented Progress
Insuring continuing provider competency is an important
step towards creating a safe health-care system, and ongoing competency examination has been adopted by many
specialty licensing boards. The American Board of Medical
Specialties (ABMS) member boards require physicians to
demonstrate specialty-specific skills, knowledge, and use of
best-practice care to maintain their specialist certification.87
The ABMS has recently added a patient safety self-assessment program to their recertification cycle, although the
standards do not take effect until 2010.88
Expect More
The Institute for Healthcare Improvement (IHI)’s 100,000
Lives Campaign and subsequent Five Million Lives Campaign were created to stimulate and measure the impact of
improved patient safety practices. This private non-profit
provided tools and technical support to more than 3,700 hospitals, and the doctors and nurses working there, that agreed
to provide IHI with measures of success on at least one of 12
patient safety practices supported by the campaigns.81 A network of “mentoring” hospitals shared information regarding
methods for system changes. These campaigns introduced
many hospital workers to life-saving practices, though IHI
did not reveal which hospitals implemented which practices.
IHI publicized anecdotal evidence of the positive outcomes
of the campaign, but did not provide the public with the
results at individual hospitals.82 Even though this was the
broadest patient safety effort of the past decade, the decision
to withhold specific validated results for the public makes it
impossible to assess the full impact it had on improving the
safety of patients.
Not all progress is private. One promising action – withholding payments to hospitals when patients are harmed was recently initiated by Medicare, the largest health care
purchaser in America. In October 2008, Medicare stopped
paying for certain preventable hospital acquired conditions.
These conditions include several hospital-acquired infections and some of the “never events” endorsed by the
Systematic Failure
Despite the action taken by the ABMS, these continuing
competency standards do not apply to the 15% of physicians
not certified by one of the 24 ABMS member boards, or
those physicians ‘grandfathered’ prior to the adoption of the
standards.89 These remaining doctors, as well as nurses and
other health-care professionals, are primarily licensed at the
83 Tsai, Joyce. “Medicare, insurers to stop reimbursing for errors,” Dallas Business Journal. 10/17/08.
Author’s note: Medicare policy withholds additional payment follow patient harm, but will not pay at all
for wrong surgery: wrong patient, wrong site, wrong procedure.
84 Brown, Jill. “Blue Cross Plans, Providers Work to Develop ‘Never-Events’ Policies,” AIS’s Health
Business Daily. 11/3/08. Internet Source: http://www.aishealth.com/Bnow/hbd110308.html. (Accessed
4/15/09)
Wolke, Anna “Infection Correction,” State Legislatures Magazine. April 2009. Internet Source: http://
www.ncsl.org/magazine/articles/2009/09slapr09_infection.htm#me, p. 22. (Accessed 4/15/09)
85 “Leapfrog Members,” Leapfrog Group Website. Internet Source: http://www.leapfroggroup.org/for_
members/who_are_members. (Accessed 4/12/09)
“The Leapfrog Group Fact Sheet” Internet Source: http://www.leapfroggroup.org/about_us/leapfrogfactsheet. (Accessed 3/29/09)
86 Leapfrog Group website,“For Members” Leapfrog Group Website. Internet Source: http://www.leapfroggroup.org/for_members. (Accessed 4/12/09)
Leapfrog Group website, “What does Leapfrog ask hospitals?” http://www.leapfroggroup.org/for_consumers/hospitals_asked_what. (Accessed 3/29/09)
80 Kohn, 1999, pp. 11-12.
81 “Reaping the Harvest: A Review of the 5 Million Lives Campaign’s First Year… and a Preview of
What’s to Come,” The Institute for Healthcare Improvement. Undated Brochure. Internet Source: http://
www.ihi.org/NR/rdonlyres/A528208C-8B71-4559-BFF3-F1FBDC4CD11C/0/ReapingtheHarvestBrochureFINALwebedition.pdf (Accessed 4/12/09).
IHI website, Overview, 5 million Lives Campaign, http://www.ihi.org/IHI/Programs/Campaign/Campaign.
htm?TabId=1 (Accessed 5-11-09).
82 “New Results from IHI Programs” The Institute for Healthcare Improvement Website Internet Source:
http://www.ihi.org/IHI/Results/NewfromIHIPrograms/#HAI (Accessed 4/12/09).
87 “ABMS Maintenance of Certification,” American Board of Medical Specialties. Internet Source: http://
www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx (Accessed 3/30/09)
88 “New Standards Adopted to Elevate Physician Life-Long Learning Assessment for the ABMS Maintenance of Certification (MOC) Program” Press Release 3/26/09. Internet Source: http://www.abms.org/
News_and_Events/Media_Newsroom/Releases/release_NewMOCStandards_03262009.aspx (Accessed
3/30/09)
89 American Board of Medical Specialties. “American Board of Medical Specialties Board Certification
Editorial Background,” Internet Source: http://www.abms.org/news_and_events/media_newsroom/pdf/
abms_editorialbackground.pdf (Accessed 5/6/09)
May 2009
Page 12
state level. The IOM report called for such licensing bodies
to “implement periodic re-examinations and re-licensing of
doctors, nurses, and other key providers, based on both competence and knowledge of safety practices.”90
No state medical boards require routine testing of skills and
competency.91 Requirements for license renewal are generally limited to continuing education, despite research indicating that continuing education alone has little or no impact on
practitioner competency.92 Once practitioners earns medical
license, they may never have to demonstrate their medical
competency again. Professionals can become incompetent
over time because they don’t keep up with current medical
knowledge, they suffer from drug addiction, alcoholism or
mental illness, or they just weren’t that good in the first place
and their shortcomings only become evident as they treat
patients day after day. Without ongoing testing, these kinds
of problems may not be recognized by licensing agencies
before serious harm occurs.
The progress of individual hospitals on these goals is not
publicly posted, so, after seven years of the program, the
public cannot assess the program’s impact, if any. Several
studies have outlined shortcomings in the ability of the Joint
Commission to detect serious deficiencies in its accreditation process. For example, a 2004 study by the GAO found
that the Joint Commission failed to identify 60% of severe
deficiencies in infection control procedures identified by
state survey agencies.98
Finally, national leaders in patient safety remain concerned
about the lack of competency in patient safety. In October
2008, the Lucian Leape Institute, founded by the National
Patient Safety Foundation to provide strategic direction
for the field of patient safety, held a meeting of experts on
Medical Education Reform.99 Discussions centered around
the need to change the culture of medical education as well
as the need to educate physicians on best practices supported by clinical research (“evidence-based medicine”).
This compares poorly with standards in other high-risk The meeting sought ideas for improving the patient safety
fields. Ironically, New York City police officers must dem- competency of doctors, which most participants agreed as
essential to reducing medical
onstrate firearms proficiency
harm. The Institute intends to
in requalification tests at
least twice a year.93 The Fed- “The publication of To Err Is Human was the vanguard to im- issue a report summarizing
eral Aviation Administration prove patient safety. Upon nearing the report’s 10-year anni- the recommendations of the
(FAA) requires airline pilots versary, little appears to have changed with significant barriers roundtable, but it has not yet
to pass ongoing proficiency encountered when attempting to track progress.”
been released.100
94
testing; this testing is often implemented through the – Simon C. Mathews and Dr. Peter J. Pronovost, December Expect More - Conclusion
use of flight simulators. The 2008.1
There has been some piecetechnology for medical care
meal action on patient safety
training simulators exists and
Mathews, Simon C. and Peter J Pronovost. “Physician Autonomy and Informed Decision Making:
by peers and purchasers, but
pending federal legislation 1Finding
the Balance for Patient Safety and Quality,” JAMA. 2008; 300(24):2913-2915.
no comprehensive national
envisions more of this kind
action by regulators, espeof learning.95 Nevertheless,
the use of medical care simucially in regards to the IOM’s
lation to assess physician competency is not widespread and practitioner competency recommendations. There is no eviis not required for maintaining a license.
dence to assure the public that physicians, nurses, and other
health-care providers are any more competent in patient
Hospital accreditation is another systematic attempt, like li- safety practices than they were ten years ago. Relying on
censing, to ensure competency and adoption of patient safety private organizations to provide increased awareness and
standards. The Joint Commission adopted priorities and pro- improved patient safety practices is an arbitrary and fragtocols to increase patient safety as accreditation standards in mented process. Nothing is in place to assure the public that
2002.96 These “National Patient Safety Goals” focus on the a health-care professional is competent. It is practicing 21st
health care delivery process.97
century medicine with 19th century oversight.
Conclusion:
90 Kohn, 1999, pp. 134-135.
91 Our review of news reports and academic literature on continuing competency failed to identify any
states requiring routine testing of physicians after receiving their initial license. We did find some references to voluntary programs.
National Failure on Patient Safety
92 Swankin, David, Rebecca Arnold LeBuhn, Richard Morrison. “Implementing Continuing Competency
Requirements for Health Care Practitioners” AARP Public Policy Institute, July 2006, p. 9.
Almost ten years ago, To Err is Human described the magnitude of the medical error problem in the U.S. health-care
system. Despite a decade of work, we have no reliable evi-
93 Rostker et al. “Evaluation of the New York City Police Department Firearm Training and FirearmDischarge Review Process,” RAND, 2008, p. xviii.
94 Code of Federal Regulations. 14CFR121.915 (b)(1)(i) U.S. Government Printing Office. January 1,
2008. Internet Source:
http://edocket.access.gpo.gov/cfr_2008/janqtr/14cfr121.915.htm (Accessed 3/16/09)
95 The Enhancing SIMULATION Act of 2009, H.R. 855 (111th Congress).
98 GAO “Medicare: CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals”
GAO-04-850 July 2004, p. 14.
Press Release “Forbes Reintroduces Bipartisan Legislation to Reduce Health Care Costs,” 2/17/2009.
See also: OIG “The External Review of Hospital Quality: The Role of Accreditation” OEI-01-97-00051.
July 1999, p. 2.
96 The Joint Commission Website. “Facts about the National Patient Safety Goals,” Internet Source: http://
www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/npsg_facts.htm (Accessed 3/16/09)
99 Press Release “Lucian Leape Institute Thought Leaders Define Strategies for Patient Safety,” National
Patient Safety Foundation. 10/30/08. Internet Source: http://www.npsf.org/pr/pressrel/2008-10-30.php
(Accessed 4/15/09)
97 “Standards Improvement Initiative (SII): Chapter Outline; National Patient Safety Goals (NPSG);
Program: Hospital,” Joint Commission. Pre-publication copy. 2008
100 Comments of conference attendee Lisa McGiffert, Consumers Union. 4/12/09.
Page 13
dence that we are any better off today. More than 100,000
patients still needlessly die every year in U.S. hospitals and
health-care settings – infected because of sloppy compliance
with basic cleanliness policies, injured by failure to follow
simple checklists for safety – the equivalent of a national
disaster every week of every year.101
Since the IOM report was issued, there have been countless task forces, conferences, editorials, and even episodes
of Oprah focused on patient safety. But action on key recommendations has been sluggish, leaving us without reliable
means to track our progress or hold the local health-care systems accountable for ending preventable patient harm. We
have failed to make the systematic changes in health care
needed to end preventable medical harm.
•
better training in patient safety for doctors and nurses.
When the IOM sounded the alarm in 1999 it called for immediate action and asked “Must we wait another decade to
be safe in our health system?”102 Ten years later, we find ourselves asking the same question. As the nation begins to reform our health-care system, we have an opportunity to take
effective and accountable action to make health care safer
for all Americans. The time to act is now. We cannot wait
another decade.
Hospital-acquired infections
kill 99,000
Americans
Next Steps
Patients, consumer organizations, and advocates alarmed by
the lack of public accountability surrounding patient safety
have issued a Patients’ Call to Action to underscore the need
for implementing the IOM’s key recommendations, including:
• effective action by the FDA, drug manufactures, hospitals, doctors, and other health-care providers to prevent
medication errors;
• increased accountability through mandatory, validated
and public reporting of preventable medical harm, including health care-acquired infections; and
each year
That’s the equivalent of a
jumbo jet full of passengers
crashing every other day
Consumers Union’s Safe Patient Project
Consumers Union’s Safe Patient Project (www.safepatientproject.org) builds on the success of its Stop Hospital Infections
campaign. It seeks to eliminate medical harm in our healthcare system through public disclosure of health-care outcomes
(such as hospital-acquired infection rates and incidents of medical errors) and information about health-care providers (such
as complaints against and license violations of physicians and
hospitals). The campaign also works to improve drug safety by
ensuring that consumers have full information about prescription drugs by strengthening oversight of the FDA and by ending
practices that create conflicts of interest, such as drug company
gifts to doctors.
Safer patient care must be a priority
in any health reform package
passed by Congress, including:
Consumers Union’s Stop Hospital Infections campaign (www.
stophospitalinfections.org) was launched in 2003 and has led a
national consumer movement for public disclosure of infection
rates in hospitals and other health-care facilities. To date, 26
states have enacted laws requiring publication of certain infection rates by hospital, and eight states have issued reports.1
• Increased
public
accountability
for
hospital
infections and medical errors
• Better training in patient
safety for doctors and nurses
1States that have passed laws: AL, CA, CO, CT, DE, FL, IL, MA, MD, MN, MO, NJ, NY, NH, OH, OK,
OR, PA, RI, SC, TN, TX, VA, VT, WA, WVA (from “Summary of State Laws on Hospital-Acquired
Infections,” Consumers Union, May, 2009. Internet Source: http://cu.convio.net/hospital_infection_disclosure_laws)
Imagine the government response if planes
started dropping from the sky.
• Aggressive
action
prevent
medication
Why isn’t Washington doing more to protect
patients from deadly hospital infections?
To learn more, sign the petition
and find out how you can help,
visit:
States that have issued reports: CO, FL, MA, MO, NY, PA, SC, VT. (See also: http://www.stophospitalinfections.org/learn.html)
101 We have adopted the 100,000 annual estimate as the absolute minimum lower boundary of deaths
due to medical harm in hospitals in the United States. This includes 99,000 annual deaths from hospitalacquired infections estimated by the CDC plus 2,039 deaths among Medicare patients alone from “accidental puncture or laceration.”
to
errors
www.SafePatientProject.org
102 Kohn, 1999, p. 5.
May 2009
Short Paper/Case Study Rubric (Graduate)
Guidelines for Submission: Short papers should use double spacing, 12-point Times New Roman font, and one-inch margins. Sources should be cited according
to a discipline-appropriate citation method. Page-length requirements: 2–4 pages.
Critical Elements
Main Elements
Inquiry and Analysis
Integration and
Application
Critical Thinking
Research
Writing
(Mechanics/Citations)
Exemplary (100%)
Includes all of the main
elements and requirements
and cites multiple examples to
illustrate each element
Provides in-depth analysis that
demonstrates complete
understanding of multiple
concepts
All of the course concepts are
correctly applied
Draws insightful conclusions
that are thoroughly defended
with evidence and examples
Incorporates many scholarly
resources effectively that
reflect depth and breadth of
research
No errors related to
organization, grammar and
style, and citations
Proficient (90%)
Includes most of the main
elements and requirements
and cites many examples to
illustrate each element
Provides in-depth analysis that
demonstrates complete
understanding of some
concepts
Most of the course concepts
are correctly applied
Draws informed conclusions
that are justified with evidence
Needs Improvement (70%)
Includes some of the main
elements and requirements
Not Evident (0%)
Does not include any of the
main elements and
requirements
Value
25
Provides in-depth analysis that
demonstrates complete
understanding of minimal
concepts
Some of the course concepts
are correctly applied
Draws logical conclusions, but
does not defend with evidence
Does not provide in-depth
analysis
20
Does not correctly apply any of
the course concepts
Does not draw logical
conclusions
10
Incorporates some scholarly
resources effectively that
reflect depth and breadth of
research
Minor errors related to
organization, grammar and
style, and citations
Incorporates very few scholarly
resources that reflect depth
and breadth of research
Does not incorporate scholarly
resources that reflect depth
and breadth of research
15
Some errors related to
organization, grammar and
style, and citations
Major errors related to
organization, grammar and
style, and citations
10
Total
20
100%
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