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Devorah Adler's Files
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Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. note
re: phone number (1 page)
n.d.
P6/b(6)
002. form
re: Sentinel Event Questionnaire Executive Summary (partial) (1 page)
02/17/2000
P6/b(6)
COLLECTION:
Clinton Presidential Records
Domestic Policy Council
Devorah Adler
OA/Box Number: 20470
FOLDER TITLE:
Errors [Folder 4]
2012-0463-S
rc747
RESTRICTION CODES
Presidential Records Act - [44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)|
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information |(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRAJ
b(7) Release would disclose information compiled for law enforcement
purposes |(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
Medical Errors
nance organization Kaiser Perma-
nente Southern California and an
complex medical system. Most are
expert in evidence-based medicine.
medication errors, Berwick said.
"It's an ideal opportunity to in-
Blamed for
"People get the wrong drug or the
crease quality and decrease costs."
wrong dose or they get it at the
Medical errors can range from a
wrong time or it's given to the
simple miscommunication about a
wrong patient."
Many Deaths
drug's name during a telephone call
Part of the problem is that many
between a doctor and a nurse to the
new drugs have similar names,
erroneous programming of a com-
which are easily confused when or-
plex medical device at the end of a
ders are given by voice or are hand-
As Many as 98,000 a Year
busy hospital night shift. They in-
written.
clude wrong diagnoses from misla-
"Physician handwriting has tra-
In U.S. Linked to Mistakes
beled blood tubes, mistaken treat-
ditionally not been something that
ments because of poorly labeled
has been looked upon highly by cal-
drugs, improper dosing because of
By RICK WEISS
ligraphers," said Peter Honig, depu-
AI
faulty calculations and a simple lack
ty director of the Food and Drug
Washington Post Staff Writer
of communication as a patient gets
Administration's office of postmar-
passed from one provider to the
keting drug risk assessment, the
As many as 98,000 Americans die unnecessarily ev-
next.
federal unit responsible for tracking
ery year from medical mistakes made by physicians,
To address the wide range of
medication errors.
pharmacists and other health care professionals, ac-
Within the past year, Honig said,
cording to an independent report released yesterday
problems, the report calls for man-
the FDA has created a "medical er-
that calls for a major overhaul of how the nation ad-
datory federal reporting require-
rors group" with the explicit job of
dresses medical errors.
ments for serious medical acci-
More Americans die from medical mistakes than
dents. And it calls upon Congress to
preventing medication errors. The
from breast cancer, highway accidents or AIDS, accord-
create and fund a national patient
team reviews new package designs
ing to the report from the Institute of Medicine, an arm
safety center within the Depart-
and proposed names for new drugs
of the National Academy of Sciences. That costs the na-
ment of Health and Human Servic-
to make sure they are not too simi-
tion almost $9 billion a year, the congressionally char-
es, which would be charged with
lar to existing ones. In some cases,
tered research group concluded.
developing better systems for track-
companies are also addressing the
Yet while other areas of the U.S. economy have coor-
ing and preventing patient injuries.
problem. Honig said. Recent ads in
dinated safety programs that collect and analyze acci-
The report also suggests that mi-
medical journals from the makers of
dent trends, including those that track nuclear reactor
nor medical errors that have not re-
the arthritis drug Celebrex, for ex-
accidents, highway crashes and airline disasters, there
sulted in serious injuries or death
ample, warn doctors not to confuse
is no centralized system for keeping tabs on medical er-
be collected in a confidential data-
their product with the anti-seizure
rors and using that information to prevent future mis-
base, not available for public re-
drug Cerebyx or the antidepressant
takes.
view. The hope is that by reducing
Celexa.
If such a system were put in place, the report pre-
health care providers' legal expo-
Most serious mistakes occur in
dicts, the number of deaths from medical mistakes
sure and the risk of lawsuits, doc-
busy settings such as emergency
could be cut in half within five years.
tors, hospitals and others may be
rooms and intensive care units, ac-
"These stunningly high rates of medical errors, re-
more open about their errors, and
cording to the report. In some cases
sulting in deaths, permanent disability and unnecessary
thus give the nation a chance to
they occur because medicines are
suffering, are simply unacceptable in a medical system
learn from their mistakes.
kept in stock at concentrations
that promises first to 'do no harm," said William C.
"Safety is a cultural matter, and
known to be toxic, when they prob-
Richardson, president of the W.K. Kellogg Foundation
ably should be stored in the diluted
and chairman of the expert committee that compiled
unless you create a cultural environ-
forms in which they are intended to
the blunt, 223-page report.
ment in which it becomes safe to
be given.
Several medical and public policy organizations have
talk about errors and near misses,
addressed the issue of medical errors since the widely
you can't get to work on the root
reported death of Boston Globe health columnist Betsy
causes of error," said Donald M.
Lehman, who died from a chemotherapy overdose in
Berwick, a Harvard professor of
1995. But experts said the prestige of the National
health care policy and president of
Academy of Sciences, and in particular its specific pro-
the Institute for Healthcare Im-
posal to create a federal office to oversee medical acci-
provement, a not-for-profit educa-
dent trends and devise strategies for prevention, could
tional and research organization,
spur real change.
who was one of 19 experts who
"There's not a controversy here," said David Eddy, a
worked on the report.
senior adviser to the Pasadena-based health mainte-
"You can't use fear or blaming of
individuals as a foundation for safe-
ty improvement," Berwick said.
"We want to set up an environment
where more errors will be re-
vealed."
The report concludes that most
errors are not the result of flagrant
recklessness but occur because of
the cumulative opportunities for
human error that arise in today's
The Washington Post
TUESDAY, NOVEMBER 30, 1999
Bradley: U.S. Spread Too Thin
Candidate Calls for Fewer Interventions and More Alliances
By MIKE ALLEN
AI
the START II treaty reducing nu-
clear and friends were obvious.
Washington Post Staff Writer
clear warheads has never been
"The choices are no longer so
ratified by the Russian parlia-
stark," he said.
MEDFORD, Mass., Nov. 29-
ment. "I am in favor of moving be-
Bradley said he would work to
Bill Bradley called today for the
yond START II, even in the ab-
restore one mindset of the Cold
United States to reduce its unilat-
sence of ratification by Russia, to
War, when "men and women of
eral overseas interventions and in-
negotiations on START III," he
goodwill in both parties joined to-
stead work with the United Na-
said, giving a goal of reducing
gether to do what was in Amer-
tions and other international
arms stocks to 1,000 to 2,000
ica's best interest."
organizations to build security in a
warheads for each side.
"There was an old saying that
world that lacks the Cold War's
Bradley opposes the immedi-
political division stopped at the
predictability.
ate deployment of a national mis-
water's edge," he said. "Sadly,
"We cannot give an open-ended
sile defense, a step that would re-
that consensus has vanished. For-
humanitarian commitment to the
quire renegotiating or breaking
eign policy has become more of a
world," Bradley said, charting his
the antiballistic missile treaty
political football, or is made to
foreign policy in a discussion with
with Russia. He favors ongoing
score domestic political points. I
Tufts University students. "The
research but is concerned about
the diplomatic consequences of
deplore that. One of the things
United States has been spread very
that I will try to restore if I be-
thin over a wide territory in the
deployment. Gore has said he
wants to negotiate with Russia
come president of the United
world and has not had the impact
about the deployment of the sys-
States is a bipartisan foreign pol-
that we seek to have in places that
tem while Bush has said he would
icy consensus."
we do get involved."
build it even over Russian ob-
Drawing an implicit contrast
Bradley contended that America
jections.
with Bush, Bradley said he was
has neither the resources nor the
Bradley endorsed an open
comfortable with international af-
wisdom to soothe every hot spot.
world trading system, but said
fairs and had needed no crash
"The key is to get multilateral ef-
the World Trade Organization
course. "I've been thinking and
forts to intervene earlier, before
should give labor organizations
speaking and writing about for-
things reach the point where only
and environmentalists a role in
eign policy for more than 20
there is a military option," he said.
shaping the rules of international
years, he said.
"That requires partners in the
commerce, allow such groups to
Bradley had planned to give a
world to do this, alliances with in-
file "friend-of-the-court" briefs in
formal foreign policy address to-
ternational organizations."
trade disputes and let such orga-
day, but postponed that to an un-
In a rebuke to Vice President
nizations participate in subcom-
determined time for reasons his
Gore, his rival for the Democratic
mittees within the WTO.
staff would not disclose. Instead
presidential nomination, Bradley
But the former senator's most
he simply outlined the framework
also said that the United States
striking comments concerned
of his policy and then answered
had "missed a real opportunity" in
U.S. interventions abroad, an ar-
responding to overtures from Rus-
questions from the students, jok-
ea where the Clinton administra-
ing that he would move to the
tion has built a long and contro-
sian leaders in the years since the
next questioner if he didn't know
versial record with missions in
fall of communism. He said the
the answer or thought the inquiry
Halti, Bosnia, Kosovo and else-
Clinton administration focused too
was stupid. At one point, he said
where. Robert Kagan, a specialist
much on encouraging Russia to
that when he was 9 or 10 years
in foreign policy at the Carnegie
adopt domestic economic reforms,
old, he had designed his own
Endowment for International
instead of pushing for deep reduc-
bomb shelter, marking spaces for
Peace, said Bradley "wants to
tions in nuclear arms and other
a cot, his favorite books and his
wrap overseas intervention
basketball.
weapons.
around Al Gore's neck in the
Though carefully measured,
Walter Mead, senior fellow at
same way that Republicans in
Bradley's comments placed him
the Council on Foreign Relations.
Congress have wanted to wrap it
firmly to the left of Gore and other
around President Clinton's neck."
said Bradley's approach distin-
presidential candidates on foreign
Speaking at the Fletcher
guished him at a time when the
policy issues. While Republican
School of Law and Diplomacy,
other candidates were promoting
frontrunner George W. Bush and
which was founded in the midst
"an aggressive style of national
other GOP candidates have also
the Great Depression in an ef-
leadership."
criticized the Clinton administra-
fort to boost internationalism at a
"Bradley is saying that United
tion's foreign interventions, Brad-
time of isolationism, Bradley de-
States influence in the world is
ley differs from them in calling for
scribed "a disturbing paradox,
greatest, and costs the least,
greater reliance on the United
where we're more powerful than
when the United States cooper-
Nations and other international
ever before, but we're also more
ates with other leading powers,"
organizations.
vulnerable to a variety of threats."
he said.
Bradley's call for more exten-
"The great risk of nuclear holo-
However, Ted Galen Carpen-
sive and far-reaching negotiations
caust with the Soviet Union has
ter, the Cato Institute's vice presi-
with Russia on arms control and
receded,' he said. "But there are a
dent for defense and foreign pol-
other issues is also distinctive. He
multitude of smaller threats—
icy studies, said he saw "a
said today he would work to ne-
kcm troublemaking dictator-
fundamental contradiction" in the
gotiate a new missile-reduction
ships like Iraq, to poorly safe-
idea of a more robust United Na-
treaty with Moscow, even though
guarded nuclear warheads in Rus-
tions and a more passive United
sia,to the increasingly dangerous
States, given the country's domi-
situation on the Korean peninsula
nance in that organization.
to transnational terrorists."
Bradley declared that "in this
new world, the next president has
an even heavier burden, which is
to try to create a comprehensive
framework for peace and security
and prosperity." He said the Unit-
ed States must work through in-
ternational institutions to "help
mold this international system."
He said that too many United
States policies, and even its mil-
itary strategy, are remnants from
those days when enemies were
The Washington Post
TUESDAY, NOVEMBER 30, 1999
care
&
R THE
ea
THE
eu
care
&
Century
THE
Draft 12/2/99
NEWS RELEASE
FOR IMMEDIATE RELEASE
DRAFT
Contact: Carol Schadelbauer, 202-626-2342
[email protected]
Alicia Mitchell, 202-626-2339
[email protected]
AMERICAN HOSPITAL ASSOCIATION LAUNCHES
MEDICATION SAFETY CAMPAIGN
Partnering with the Institute for Safe Medication Practices
Washington (December 9, 1999) - In an effort to reduce medication errors in hospitals and
health systems the American Hospital Association (AHA) is initiating a medication safety
campaign that will help hospitals examine and improve their efforts toward medication error
reduction and prevention.
As part of the campaign, the AHA will partner with the Institute for Safe Medication
Practices (ISMP), Huntingdon Valley, Pa. - a premier organization in the area of medication
error safeguards and reporting. The ISMP will help AHA provide hospital leaders with a
checklist of successful practices for reducing errors that can be adopted in every hospital.
The checklist is formulated from the work of experts and organizations that have been
studying medication error, including ISMP, the Institute for Healthcare Improvement, the
Massachusetts Coalition for the Prevention of Medical Errors, the National Coordinating
Council on Medication Reporting and Prevention, the National Patient Safety Partnership and
many others.
"Our nation's hospitals deliver the best health care in the world, but we also need to be the
best at providing that care with as little risk as possible," said AHA President Dick
Davidson. "It is tragic when any patient's safety is compromised, and it's our job to address
this. We're pleased to partner with the Institute for Safe Medication Practices to provide
leadership and technical expertise to hospitals."
NO.
you
The initiative will focus on medication errors, which make up the largest percentage of all
medical errors. The commitments of the campaign include:
Sharing the successful practices list with every hospital and health system.
Developing a "medication safety awareness test" for use by hospitals developed by ISMP
that surveys hospitals' medication error prevention systems.
Tracking implementation by the hospital and health system field of the practices for
reducing and preventing errors on an ongoing basis.
Working with national experts to develop a model medication error reporting process.
Serving as a clearinghouse of information and resources for the hospital field on
medication error.
"We are delighted to join the AHA on this medication safety effort because it will take
commitment from the leaders of hospitals and health systems to bring this issue the attention
it deserves," said Michael Cohen, ISMP president. "ISMP already has a system in place that
quickly reports medication errors as they occur nationally. Many hospital pharmacists,
health care workers and analysts access it regularly. And we will be encouraging hospitals
who haven't tapped into this to do so."
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization that works
closely with healthcare practitioners and institutions, regulatory agencies, professional
organizations and the pharmaceutical industry to provide education about adverse drug events
and their prevention. The Institute provides an independent review of medication errors that
have been voluntarily submitted by practitioners to a national Medication Errors Reporting
Program (MERP) operated by the United States Pharmacopeia (USP). Information from the
reports may be used by USP to impact on drug standards. All information derived from the
MERP is shared with the U.S. Food and Drug Administration (EDA) and pharmaceutical
companies whose products are mentioned in the reports.
NU.983
P.3/11
DEC. 6.1999
5:39PM
HAH
The American Hospital Association is a not-for-profit association of health care provider
organizations and individuals that are committed to health improvement of their communities.
The AHA is the national advocate for its members, which includes 5,000 hospitals, health
care systems, networks, and other providers of care, and 37,000 individuals. Founded in
1898, the AHA provides education for health care leaders and is a source of information on
health care issues and trends. For more information, visit the AHA web site at
www.aha.org.
-30-
DRAF
AHA Quality
AIHA
Advisory
AMERICAN HOSPITAL ACCOUNTION
AHAS Quality Advisory, a service 10 AHA members, will be produced whenever there is a
FOUNDED
'8681
significant development that affects the job you do in your community.
Improving Patient Safety
by Reducing and Preventing Medication Errors
December 6, 1999
To All AHA Members:
Primum non nocere. Above all, do no harm. Healers have lived by this motto for thousands of
years. The minimum our patients expect from us is safe and compassionate care when they enter
a hospital. And they deserve to get it.
But today, in the complex, high-tech world of medicine, our best intentions can have unwanted
consequences. And those consequences are contributing to the public's eroding confidence and
trust in the health care system.
Following up on discussions with the AHA Board of Trustees and Regional Policy Boards on
improving hospitals' accountability to their communities, the AHA is developing an initiative to
help you improve patient safety by reducing and preventing medication errors. To provide
leadership and technical expertise in this effort, we have formed a relationship with the Institute
for Safe Medication Practices (ISMP), a not-for-profit research and education organization
dedicated to reducing the incidence of medication error throughout the health system.
This is what you can expect from us in the coming months.
First, we will provide you with strategic and practical advice to reduce the potential for and
incidence of medication error. To jump start this initiative, we are attaching several successful
practice recommendations compiled from respected sources.
Next, together with ISMP, we are developing a "Medication Safety Awareness Test" that will
help you assess your progress on implementing recommendations in your hospital, and that will
enable us to track and demonstrate your success at improving medication safety.
(More)
The recommendations that follow can greatly improve patient safety. The first set can be
implemented immediately; they focus on standardization and simplification of processes that will
likely reduce the potential for human error. The second set require changes to existing
organizational systems; they will likely require a longer-term implementation plan and may rely
on computerization of the physician order-entry and pharmacy dispensing processes.
Here are some ways to get started:
Organize a senior management team to review and discuss the attached recommendations.
This team could include the CEO, chief medical officer, chief operating officer, chief nurse
executive, director of pharmacy, risk manager, director of information systems, and others.
Some organizations also include patients on this team. Assess your organization's processes
as they compare to the recommendations and track your progress on implementing changes.
Review your policies and procedures for reporting and investigating errors. Create an open,
non-punitive culture that evaluates and corrects errors.
Review information about incidents that occur within your institution and use it to find
opportunities for improvement.
Make sure your staff takes advantage of the tremendous amount of information available
from organizations like the ISMP, the Institute for Healthcare Improvement, the Food and
Drug Administration, the U.S. Pharmacopeia, the National Coordinating Council on
Medication Error Reporting and Prevention, the National Patient Safety Foundation, and the
American Society for Health-System Pharmacists.
Please be certain to keep your Board of Trustees and organized medical staff up to date on all
the actions you're taking.
Look for more from us in the near future. We'll provide strategic and practical advice on
reducing error, and we'll be your clearinghouse for information and resources. We're committed
to helping you create a safer, more effective, and more efficient health care system.
Dick Davidson
President
December 6, 1999
AHA Quality Advisory
HOSPITAL
December 6, 1999
1898
Improving Patient Safety
by Reducing and Preventing Medication Errors
Background
Most of what has been learned in recent years about how to reduce medication error and increase
patient safety is based on two principles. First, although errors are committed by individuals,
they happen because of the systems in which those individuals work. As a result, reducing error
will require us to design and implement more error-resistant systems. Second, we have to create
an environment in which we can learn from our mistakes - a safe, non-punitive environment that
supports open discussion of errors, their causes, and ways to prevent them.
These principles have a common denominator - they require the leadership and commitment of
senior executives and medical staff to create change within our organizations.
Common Sources of Error
Medication systems in hospitals are complex and multi-layered, involving many steps and many
individuals. This complexity ripens the opportunity for error. Error can occur at any stage -
prescribing, ordering, dispensing, administering, or monitoring the effects of a medication.
According to the Institute for Safe Medication Practices, some common sources of medication
error in health systems include:
Unavailable Patient Information: Critical patient information (diagnoses, lab values, allergies,
drug contradictions, etc.) is often unavailable to pharmacy, nursing, and medical staff prior to
dispensing or administering drugs.
Unavailable Drug Information: Pharmacists often are not readily available on patient care units
and written resources may not be up-to-date, which can lead to dose miscalculations or ignorance
of drug interactions. Because errors occur most often during the prescribing and administration
stages, accessible drug information must be readily available and close at hand for all staff who
prescribe and administer drugs.
Miscommunication of Drug Orders: Failed communication is at the heart of many errors. This
includes poor handwriting, confusion of drugs with similar names, careless use of zeroes and
decimal points, confusion of metric and apothecary systems, use of inappropriate abbreviations,
ambiguous or incomplete orders, and, sometimes, conflicts between practitioners.
Problems with Labeling, Packaging and Drug Nomenclature: Most drugs are dispensed
through unit dose systems that parse medications into smaller-sized doses. These systems,
however, do not always provide for thorough preparation, packaging, and labeling of
medications, with screening and checking by both nursing and pharmacy personnel, and they
may not be available throughout every unit in the hospital (e.g., ERs and ICUs). Drug
administration procedures often do not ensure that medications remain labeled until they reach
the patient's bedside, a frequent source of error.
Drug Standardization, Storage, and Stocking: Stocking multiple concentrations of the same
drug, or storing drugs in look-alike containers or in ways that obscure drug labels, may
contribute to error. Lack of safety procedures for use of automated dispensing technology or
inadequate check systems may also contribute to errors.
Drug Device Acquisition, Use and Monitoring: Lack of standardization in drug delivery
devices, improper default settings, unsafe equipment (e.g., free-flow infusion pumps), and the
lack of independent check systems for verifying dose and rate settings can all contribute to
device-related errors.
Environmental Stress: Environmental factors like lighting, heat, noise, and excessive
interruptions, can affect individual performance. The process of transcribing orders is
particularly vulnerable to distractions in the environment, as staff transcribing orders are exposed
to noise, interruptions, non-stop unit activity, and too-long or double shifts.
Limited Staff Education: Many practitioners are not as aware as they should be of situations
within their own organizations that have been reported as error-prone, or of similar information
published in professional literature.
Limited Patient Education: Medication use is a multi-step, multidisciplinary process that
begins and ends with the patient. Patient education about medications - what they are taking,
why they are taking it, and how they should take it is essential to successful medication
administration. Patients can be partners in the prevention of error while hospitalized and need to
be educated to safely self-administer medications when they go home.
Quality Improvement Processes and Risk Management: Health facilities need systems for
identifying, reporting, analyzing, and correcting errors and identifying trends, and measurement
systems for tracking the effect of system changes. Also, too few organizations take into
consideration information from outside sources about errors that have occurred elsewhere. But
above all, health organizations need to cultivate a non-punitive approach to error that will
encourage frank identification and analysis of errors when they occur.
Steps for Reducing and Preventing Medication
These potential sources of error can be controlled if we design safer systems. With this in mind,
AHA has attached to this advisory a list of successful practices for reducing and preventing
medication error and for improving overall patient safety within our hospitals and health
systems, We encourage your team to review this list of recommendations, plan for
implementation, and begin to track your progress.
Our Sources
The recommendations were culled from these reliable sources that are leaders in the effort to
reduce and prevent medication errors, and we are grateful for their pioneering efforts. They are
excellent resources for your organization's reduction and prevention efforts. They include:
American Society of Health-System Pharmacists (ASHP) (www.ashp.org)
Institute for Healthcare Improvement (IHI) (www.ihi.org)
Institute of Medicine (IOM) (www.national-academies.org)
Institute for Safe Medication Practices (ISMP) (www.ismp.org)
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (www.jcaho.org)
Massachusetts Coalition for the Prevention of Medical Errors (www.mha-link.org)
National Coordinating Council on Medication Error Reporting and Prevention (NCCMERP)
(www.nccmerp.org)
National Patient Safety Partnership (NPSP)
U.S. Pharmacopeia (www.usp.org)
Further information is available from the resources listed below.
Books
1. Cohen, Michael R., Ed. Medication Errors. Washington, D.C. American Pharmaceutical -
Association. 1999. (Contains a special chapter on high-risk medications and dangerous
abbreviations; rich with insight and practical advice on reducing the risk of error.)
2. Corrigan, Janet, et al. To En is Human.: Building a Safer Health System. Washington, D.C.:
National Academies Press. 1999. (Comprehensive overview of the subject of medical error,
containing many practical suggestions and recommendations from several trusted sources.)
3. Leape, Lucian, et al., Reducing Adverse Drug Events. Boston, MA: Institute for Healthcare
Improvement. 1998. (Concepts to reduce adverse events and a model for improvement.)
Patient Information Brochures
1. Your Role in Safe Medication Use: A Guide for Patients and Families is available from the
Massachusetts Hospital Association at www.mhalink.org
2. Partners in Quality: Taking an Active Role in Your Health Care is available from the
Hospital Association of Pennsylvania at www.hap2000.org
3. How to Take Your Medications Safely is available from the ISMP at www.ismp.org
4. Just Ask! is available from the US Pharmacopeia at www.usp.org
Information on Safe Medication Practices
From the Institute for Safe Medication Practices
ISMP Medication Safety Alert!
Urgent Error Advisories
From the United States Pharmacopeia
Dangerous Abbreviations
Practitioner Reporting Alerts
Drug Quality Alerts
Look-alike Sound-alike Name Lists
From the Joint Commission on Accreditation of Healthcare Organizations
Sentinel Event Alerts
Successful Practices
for Medication Error Reduction and Prevention
Immediate changes (process redesign)
The following steps can be implemented immediately by hospitals and health systems. They
focus on standardization and simplification of medication system processes.
Fully implement unit dose systems
Maintain and systematically use unit-dose distribution systems (either manufacturer-prepared
or repackaged by the pharmacy) for all non-emergency medications throughout the hospital.
Unit dose systems should include, in addition to packaging, systems for labeling and order
screening.
Stress the need for dose adjustment in children, older persons, and patients with renal or
hepatic impairment.
Limit the variety of devices and equipment
For example, limit the types of general purpose infusion pumps to one or two.
Develop special procedures and written protocols for high-alert drugs
Use a multi-disciplinary approach. These include written guidelines, checklists, dose limits,
pre-printed orders, double-checks, special packaging, special labeling, and education.
Limit the number of possible concentrations for a drug, particularly high-alert drugs like
morphine and heparin. Such standardization will allow the use of premixed solutions from
manufacturers or centralized preparation of IV medications in the pharmacy.
Ensure the availability of up-to-date drug information
Make updated information on new drugs, infrequently used drugs, and non-formulary drugs
easily accessible to clinicians prior to ordering, dispensing, and administering medications
(e.g., have pharmacists do rounds with doctors and nurses; distribute newsletters and drug
summary sheets; use computer aids; and provide access to formulary systems and other
internal resources).
Review error potential for all new products, including a literature review, before any drug or
procedure is approved for use; reassess six months to one year later.
(Successful Practices - Page 1 of 3)
Educate staff
Provide physicians, nurses, pharmacists, and all other clinicians involved in the medication
administration process with orientation and periodic education on ordering, dispensing,
administering, and monitoring medications.
Distribute information about known drug errors from outside organizations like ISMP and
USP.
Educate patients
Patients should be educated in the hospital, at discharge, and in ambulatory settings about
their medications, what they are taking, why they are taking it, and how to use it safely.
Encourage patients to ask questions about their medications.
Encourage health care providers to work with pharmacists on patient education when patients
receive certain classes of medications or are discharged on more than five medications.
Ensure the availability of pharmacy expertise
Have a pharmacist available on-call when pharmacy does not operate 24-hours a day.
Make the pharmacist more visible in patient care areas - consider having pharmacy personnel
make daily rounds on units, or enter orders directly into computer terminals on patient care
units.
Standardize prescribing and communication practices
Avoid certain dangerous abbreviations (see ISMP and USP for examples); identify a list of
unacceptable abbreviations that will not be used in your institution.
Include all elements of the order - dose, strength, units (metric), route, frequency, and rate.
Use full names (preferable generic).
Use computerized reminders for look-alike and sound-alike drug names
Use metric system only.
Use preprinted order sheets whenever possible in non-computerized order systems.
Standardize multiple processes, such as:
Doses
Times of administration (for example, antibiotics)
Packaging and labeling
Storage (for example, placing medications in the same place in each unit)
Dosing scales (for example, insulin, potassium)
Protocols for the use and storage of high-alert drugs
(Successful Practices - Page 2 of 3)
Longer-term changes (systems redesign)
The following steps will require substantial changes to existing organizational systems; they will
likely require a longer-term implementation plan and a continual focus on improvement; many of
the recommendations rely on computerization in the physician order-entry and pharmacy
dispensing processes.
Develop an effective system to monitor and report adverse drug events
Review policies for how your organization encourages reporting and analyzing errors
throughout the institution.
Encourage open communication and feedback.
Ensure no reprisals for reporting of errors.
Increase the use of computers in the medication administration system
Encourage the use of computer-generated or electronic medication administration records.
Begin planning for implementation of computerized prescriber order entry systems when
technically and financially feasible in light of a hospital's existing resources and
technological development.
Consider the use of machine-readable code (i.e., bar coding) in the medication administration
process.
Use computerized drug profiling in the pharmacy.
Be a demanding customer of pharmacy system software; encourage vendors to incorporate
and assist in implementing an adequate standardized set of checks into computerized hospital
pharmacy systems (e.g., screening for duplicate drug therapies, patient allergies, potential
drug interactions, drug/lab interactions, dose ranges, etc.).
Institute 24-hour pharmacy service if possible
alternatively, utilize night formularies and careful drug selection and storage procedures.
Resist allowing non-pharmacists to enter the pharmacy.
(Successful Practices Page 3)
Computerized Realistic Simulation:
A Teaching Module for Crisis
Management in Radiology
Gregory T. Sica 1
OBJECTIVE. Computerized realistic simulation technology has been used as a training
Deborah M. Barron 2
mol in fields such as aviation and military training and in the miclear power industry. More re-
Richard Blum
cently, is has been adapted for use in anesthesia crisis resource management. We describe the
Thomas H. Frenna I
effectiveness of a simulation program like that used by anesthesiology departments that we
Daniel B. Raemer
developed to teach radiologists the principles of crisis management.
MATERIALS AND METHODS. A mock CT scanner and patient simulator were used to
simulate the environment in which radiologists encounter crises. Twenty-four residents attended
the training program, four at each half-day session. Two responded a and two observed an ini-
tial crisis, after which they stuended a lecture and watched a videotape review. The second pair
then participated in a different edsis scenario. The scenario order was randomized. All acenarios
were videotaped and randomly reviewed by two physicians DOL involved with the course. The
following behavioral qualities of the participating residents were evaluated using & five-point
scale, ranging from poor (1) to excellent (5): global assessment. communication skills, use of
support personnel, use of resources, and rule clarity. Residents then rated the course B a five-
point scale using the following criteria: overall course usefulness, amainment of course goals, re-
alism of scenarios, quality of lecure, and quality of videotape review.
RESULTS. The trainees who bad attended the lecture and watched the videotape review
before participating in X scenario consistently scored higher than those who had not in the fol-
lowing areas (score after training/score before training): global assessment, 4.08/2.50; com-
munication skills, 4.09/2.67: use of support personnel. 4.17/3.00; use of resources, 4.00/2.92;
and role clarity, 4.17/2.67. Moreover, the participants gave the course the following average
ratings: overall usefulness. 4.93; attainment of course goals, 4.78; realism of scenarios, 4.63;
quality of lecture, 4.63; and quality of videctape review, 4.85.
CONCLUSION. Although the critical assessment of a teaching method is difficult and
subjective by nature, the improvement in behavioral performance scores suggests that simula-
non technology effectively conveyed the principles of crisis management. The course ratings
show that the program was well accepted by participants.
risis management is not a new/con- con-
implementing treatment algorithms. One m
cept. although formal training in this
source for radiologists is a manual published
Received June 29,
accepted after revision
field is not typically incorporated
by the American College of Radiology that is
August 12 1996.
into the curriculum of a mdiology residency [I].
entitled The Marual on Indinated Contrast
1 Department of Rediology. Brigham and Women's Hospital,
As radiologists, WE may encountr crisis situa-
Media (1998, 3rd ed.), although the techniques
Harvard Medical School, 75 Francis SW Baston, MA 02115
Address correspondence to G. T. Sica.
tions in both inparient and outpatient settings that
described in the manual may have been modi-
2 Department of Arjesthazia. Henrico Doctors' Hospital,
are otten related ID the administration of IV con-
fied by particular practices at individual insti-
1652 Skipwith Rd_ Richmond, VA 73229
trast agents. As the fust physician who is present
artions. Some institutions also require house
3 Department of Agesthesia, Children's Hospital, 300
to examine the patient, we are responsible for the
and amending staff to be certified in basic life
Longwood Are, Boxton, MA 02114
proper initial treatment of the patient. Decisions
support, advanced cardiac life support. or both.
"Department of Anexthesia and Critical Care.
and actions during the first few minutes of a crisis
Despite possessing technical expertise, clini-
Massachusetts General Hospital, Fruit St. Boston, MA
may critically affect patient curcome.
cias will still make entors that may be related to
02116.
Effective management of a crisis situation
behavioral skills In fact an estimated 65-70%
1999;172:301
requires both technical and behavioral skills
of the adverse incidents associated with the ad-
0361-8030/93/1722-301
[2]. Technical skills, for the most part, are
ministration of anesthesia, like those associated
© American Rosetgen Rey Society
straightforward and involve understanding and
with piloting an airplane, are attributed at some
301
AJR:172 February 1999
et aL
level to human ener despire the technical exper-
Rg. 1.-Photograph shows
.
tise of those involved [3]. These skills are an as
during simulated crisia.
Interaction between TWO residents
serial component to crisis management but are
and CT nurse.
less amenable to formal teaching. In addition.
quantifying the incremental benefit or effective
DC$8 of such a teaching program is difficult.
Realistic simulation is used a teach crisis
management skills to a variety of profession-
als such as pilats, military personnel, firefight-
at and nuclear power plant workers [1, 4].
Within the field of medicine, realistic simula-
tion is successfully used to train residents how
to administer anestheria [5-7]. Componerized
mannequin simulators emable the simulation
of re-creation of the environment in which a
point of a accurato we resolution of the patient's
course and was unsware of whether aceourios had
symptoms, stabilization of the patient. conster of the
occurred before or after the training session. All tapes
real crisis occurs, and the effectiveness of this
patient to another mill, or patient death. Both indici-
was independently reviewed twice. The first review
training tool bax been proven [8, 91.
ogy nurse and technologier were present or available
was to establish the range of behavioral responses in
At our institution, computerized realistic sim-
to simulate I typical hospital environment.
the entire group of trainecs. The accord review took
ulation has been successfully incorporated into
place within 1 mouth of the first review For the -
the aneshesiology department's training pro-
Subjects
and review. a standard crdinal rating scale of one b
gram Because we recognize due radiologists -
Both radiology residents and fellows involved in
five aa poor to excellent) was used to grade the to
also called 8 to manage crisis events and that
administering IV contract media participated in the
havioral parkmeters listed in Appendix 2 The scores
our department does not teach these skills, we
training program. The 24 participants. are divided
of the two reviewers were averaged for each sca-
developed an analogous program for rediology
into aix groups, each of which strended one half-day
rario, and the results were then separated by purame-
session a the center. The course was conducted for
residents. Wei sought to evaluate whether in
KY and by when the serverio occured as, either the
three consective days, and both acception A and B
scenario that occurred before or the one the occured
proved performance in a simulated crisis could
wat run during each session. The order of the account-
after the training session). The Wilesson's signed
result from standing QUE training session. Fur
in was revened after each session to that each -
nok last was performed a determine significance of
(bermore, we wished to determine if as inten-
masio occurred with equal frequency Ge, six times) in
differences. Internater variability was experienced = .
sive. hands-on program would be accepted by
the fine and second position and to ellminate or ever-
percentage agreement within one percentage point
radiology residents.
age out performance variability the may have been
as the scoring scale.
related a the degree of difficulty of & accountion Two
Materials and Methods
trainers were assigned B manage each securrio, and
Results
Simulation Certer
all acenarios were videotaped for review. The remain-
Reviewer agreement was considered good
A patient simmistor (Eagle Simulation. Bing-
ing no trainers WCTB allowed to watch the scenarios
to excellent in the scoring of the behavioral
hamton, NY) was fitzed a resemble a patient in a
through 1 any-way glass window.
parameters: The ratings were within one
CT scanner mdiology suite (Fig 1). Equipment
Regardiess of the order of the account. an inter-
available for une in the room included a power in-
vening review services was bold for all uninees. During
point for 73% of the parameters and within
jector, memial and electronic parient monitoring
this session, a videotape of BR airplane much -
two points for 98%.
devices, medications, and IV and patient resuracita-
shown and discuss to highlight the importance of
The behavioral parameters of those partic-
crew behaviors in CIMB of E miship. A because and dis-
ipants who were evaluated for scenarios oc-
tion supplies: The mannequin was espable of ox-
hibiting real-life physiologic responses such as
causion of the principles of crisis management (Appen-
curring after the review session had higher
redial and carotid pulses, pupillary and lid to
dix 2) followed the videotape. The videotape of the
average scores than those who managed a
ficxes. and temperature probe readings; in addi-
initial scenzio was then reviewed and critiqued by all
scenario before attending the review session,
tion, the marmequin generated breathing sounds
exinces. After this critique, the two trainees who bad
The results were the following (behavioral
and those of a person's heart and vaice These e
watched the fast scendo managed the second ONE All
parameter. score after training/score before
tributes were under semiautomated remote coutrol
traines reviewed the videompe of a second scenario.
training): global assessment. 4.08/2.50; com-
and responded dynamically. IV placement and
At the completion of & half-day session, the trainees
medication administration is through brachial, an-
responded anonymously a a wrince questionnaire
munication skills, 4.09/2.67; use of support
tecubital, or forearm veins.
- which they rated various subjective perameters
personnel, 4.17/3.00; use of resources, 4.00/
related a their perception of the value of the course.
2.92; and clarity of roles, 4.17/2.67. The dif-
Participants were instructed to approach the
mannequin in they would a live parient and to EX-
A five-point sundard ordinal raing scale was used,
ferences were significant for the following
pact the responses described. The control console
with scores of 1 to 5 ranging from poor to excellent
behavioral parameters: global assessment.
was located in a separate room. The operator had
The following parameters were rated: overall course
P < .03; use of support personnel, D < .03;
both direct and relevised visualization of the room
usefulness, attainment of courte goals, realism of
and use of resources, P < 03. A tread wward
but could not be seen by the participants.
case scenarios. quality of lecture, and quality of vid-
improvement in performance after amending a
compe review.
review session was seen for the following to
Scenarios
Two sceharios (A and B) were developed. Each
Analysis
havioral parameters: clarity of roles (P < 06)
Two reviewers, an anesthesiologist with experi-
and communication skills (p < 06).
scenario was designed to be sufficiently complex to
include a variety of potential crises a radiologist may
ence at the simulation center and a radiologist with
The subjective parameters of the overall use-
encounter (Appendix 1). The algorithma had branch
DO affiliation with the center, evaluated the video>
fulness of the course as rated by the 24 partici-
points that were activated by a specific therapeuric
tipes of the scenarios. The TWO reviewers ware BOE
pants were uniformly ranked close to excellent
receive administered by the participants. The end-
involved a any level in the radiology simulation
The average score for each parameter was the
302
AJR:172 February
DEC-21-1999 17:08
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617 432 3912
P.30
Crisis Management Training Using Computerized Simulation
following: overall course usefulness, 4.93; at-
teria The course directors agreed that these on-
just as they would for other courses at scientific
tainment of course goals, 4.78; realism of case
teria represented important behavioral goals of
or review treetings. The program could be of-
scenarios, 4.63: quality of lecture, 4.63; and
the program. The observers were DOE involved
fored as an additional workshop to a radiology
quality of videotape review, 4.85.
with the course and did not have knowledge as
department's ongoing course schedule. We are
to whether a particular session was one that had
also considering options such as live telecon-
Discussion
occurred before or after trainees had attended
ferencing of crisis events or using videotapes a
Simulation technology is successfully used
the lecture and videotape review. The results of
illustrate the principles being tanght. These P
in many fields, Lts value as a tool to teach and
their evaluations indicate that a program that
proaches would make the content of the course
refune technical and behavioral skills has been
combines the hands-on experience of realistic
available on a IRCHE widespread basis and thus
proven and is well accepted 2 3, 8]. With real-
simulation with teaching in the principles of
also significantly reduce the cost ID partici-
istic simulation, an attempt is made to re-create
crisis management can be effective.
paras, The szade-offis the loss of the experience
all aspects that are associated with & specific
Several limitations are inherent to a study
of acreally being involved in the crisis--m ex-
CTCIL Other forms of simulation may be more
such as this one. Two questions of concern
perience that is difficult to quantify.
limited, with the goal of the exercise being to
are the following: Will the improvement in
In this andy has shown that realis-
each a single task Within the medical field.
performance during the course translate into
pic simulation achnology can be an effective
several anesthesiology departments have effer-
better real-life decisions? And if so, bow
teaching tool forradiology mainees in the princi-
tively incorporated this teaching tool into their
long will this effect last? These assessments
please of crisis management The course was well
residency maining program. The simulation
will require at least the extablishment of a
regarded by the participants and can success-
center M are institution is managed and prima-
performance rating program within the do
fully be incorporated into 2 training program.
rily used by members of the department of an-
partment itself and long-term monitoring of
extheriology.
course participants. In addition, to more &
Acknowledgene
The department of radiology at our insúri-
curately meanure the effects of training. a
We wish 4. thank Steven E. Seltza for his
don manages a didactic program that consists
control group of nonparticipants would need
support and guidance in developing the sireula-
of two classroom lectures in which contrast
to be similarly followed. This task is dams-
tion center course and in editing this manuscript
media use and the detection and treatment of
ing and its impracricality may limit such an
contrast material reactions are reviewed Be
in-depth investigation.
References
cause we recognize that behavioral спитро-
We have just conducted the second annual
1. Office of Blanced Research. A review of the literature
dents are important in the management of a
course, for which we developed new case
on training transfer of training and sim
crisis and are not easily incorporated imo for-
scenarios. Resident and fellow trainee partic
whatev fidelary. Adiagion, VA: Defense Technical In
formation Cour, 1984. Report 84-1:1-73.
mai training, we adapted the simplation pm
ipants included an approximately equal BUED-
2 Gobs DM, Marwell M. DeAnda A Anestheric
gram on the basis of the anesthesiology model
ber of first-time and second-time attendees.
mishaps: breaking the chala of accident crolu-
for our department Although a case scenario
A study of the previous year's attendees who
tion. Anestheriology 1987;66:670-676
approach has been used (10]. this report. the
anend training a second time is planned to
3. Howard SK. Gaba DM, Fish KJ, Yang G, Samaprist
first in the radiology Incrature to our knowl-
discern if any residual effects of program
FEL resource management mining:
edge, describes the use of realistic simulation in
participation CAR be discerned
teaching to handle critical incl-
the training of radiologists to manage crises.
Signation training, by is nature, is ex-
denex Asia Space Environ Med 1992:63:763-770
4. Helamrich R Chidester TR. Foushee HC, Gego-
Our findings suggest that improved perfor-
pensive and can be labor intensive. The cost
rich S. Wilbolm IA. How effective is cockpit R
nance in the management of a crisis results
increases with the degree of fidelity. We at-
source management maining? Flight Sefety Digest
during one training session.
tempted to re-create crisis events encountered
19909:1-17
Subjectively, as shown by results of the
by radiologists with close attention a the physi-
5. Denton B. Abrahmson S. A compuner-controlled
questionnaires about the training that trainees
cal appearance of the environment, functional-
patient sixplaime. JAMA 1949:208:504-508
completed, all trainees enjoyed the course and
ity of equipment and drugs, and support
E. Gabu DM DeArds A. A somprehensive anesthe-
a simulation a re-creating the operat-
found it to be a highly worthwhile educational
personnel typically available or involved in-
ing good for and training, Anesthesiology
experience. The novel approach was so well
cluding one mesthesiologist (who as the -
1988;69:387-394
received by the participants that we were en-
trol center of the simulator). one radiologist,
7. Schwid HA. O'Donnell D. The anesthesia simule-
couraged to expend its scope. Fully evaluating
one radiology nurse, and one technologist. The
tox-recorder. a device to evaluate anesthesiologists
a new teaching technique such as this one,
cost per trainee for a half-day session in the ini-
responses to critical incidents. Anesthezielogy 1990:
particularly its impact on performance, is dif-
tial course was approximately $500. By in-
72:191-197
& Gabe DM. Improving anexthesiclogists perfor-
ficult Although the subjective ratings are as
creasing the number of participants from four
mance by simulating reality. Anesthesiology 1992;
important measure of participant acceptance,
to six per half- day. the cost was reduced to
76:491-494
these ratings do not necessarily correlate with
$300 per trainec, This price is close to that of
9. Chopra V, Gesink BJ, Delong J. Bovill JO, Spier-
the effectiveness of the program.
similar courses that do not offer the hands-on
dijk J, Brand R Does training on an anaesthesia
Designing measures of objective perfor-
experience of a simulation The simulation
simulator lead to improvement is performance?
mance are challenging because of the subjec-
training course is continuing-medical-ealuca-
Br J Angest 1994;73:293-297
tive name of the behavioral parameters being
tion-approved for which credits are available.
10. Echenique AM. Joseph R Casillas JV. Recogni-
tion and treatment of reactions to contrast media:
assessed. Our approach was to have two inde-
Simulation centers are not widely available,
a model for maident and faculty education em
pendent observers randomly review and score
but this factor may not limiz their use. Trainees
playing lectures and case securios workshops.
each videotaped session for several defined cri-
could travel to attend a course at such a center,
Acad Radiol 1997:4:230-234
AJR:172 February 1999
303
APPENDIA :
(001
b17 432 3912
Scenario A
Patient
70-year-old man
Medical History
Penicillin and/bee sting allergies, hypertension, depression
Medications
Propranolol hydrochloride, fluoxetine bydrochloride, IV antibiotic
Indication
Dyspoca, fever, back pain; differential diagnosis of pneumonia versus ruptured aneuryson
Study To Be Performed
CT chest with IV contrast material
Clinical Progression
Step I
Patient preseurs with progressive dyspnes that leads a laryngeal edema
Patient's condition is thought to be related to administration of IV contrast material Treatment of presumed resction to contrast marrial is unsuccessful as
long as autibiotic drip is on Trimee moit make reaction is actually caused by the IV arribiotic administered in the emergency department.
Step II
Patient develops hypotension bus has a normal-to-slow heart rate.
Traines must recognize that patient is taking beta blocker and be able a distinguish as anaphylactic reaction from a vasovagal reaction.
Step III
Parient develops abdominal pain.
Trainee must differentiate between a suppored aneuryam and intestinal angina caused by epinephrine.
Stop IV
Technologist informs trainee that IV contrast material was not administered (only if resident fails to desect that power injector is still loaded).
Trainee must realize that power injector is still loaded.
Scenario B
Patient
35-year-old woman
Medical History
Diabetes, history of cardiostryopathy, recent cardiac transplantation
Medications
Produisone, gincophage
Indication
Follow-up heart transplantation examination
Study To Be Performed
CT chest with IV contrast material
Step I
Patient presents for follow-up beart transplanzation examination.
Trainee ISSUED all patient to stop glucophage, order follow-up laboratory tests, and inform referring clinician.
Step II
IV commist material extravasates during treatment, and parient develops vasovagal reaction.
Trainee LIMIST realize that became the heart transplant lacks the vagus nerve, bradycardia will not respond to stropine.
Trainee thost order administration of IV fluids
Step III
Patient shows signs of progressive dyspoca.
Trainee must realize that progressive dyspnea is caused by fluid overload and is not associated with baryngeal edema or bronchospasms from the
administration of contrast marrial.
Trainee must treat patient with lasix and morphine, insuead of with epinephrine for anaphytaxis.
Step IV
Patient develops respiratory arrest.
Trainee must call for anesthesia a perform inmbation
APPENDIX 2: Principles of Crisis Management
Global Assessment
Avoids fixations
Verbally reviews case ID ensure clarity
Generates new ideas
Communication
Addresses patient and coworkers directly
Uses nonjudgmental language
Use of Support Personnel
Calls for help when appropriate
Asks for support from personnel who are able to provide such support
Use of Resources
Shows readiness for action
Proves an understanding of systems
Exhibits technical knowledge
Shows ability to get needed supplies and equipment
Role Clarity
Participares as a leader rather than as a follower
Articulates goals
Manages event
304
AJR:17Z February 1999
DEC-21-1999 17:09
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61
February 3, 1998
Dean Joseph Martin
25 Shattuck St., Suite Alll
Boston, MA 02115
Dear Dean Martin:
We are writing to express our enthusiasm for the simulator program at the Center for Medical Simulation and to
encourage you and the medical school to further expand support for this program.
We represent the first group of medical students who have had the good fortune to be involved with The Center for
Medical Simulation (CMS). As background, the Center was started in the mid-1990s by the anesthesia chiefs at the
Harvard teaching hospitals as an innovative way to prepare their residents for the challenges they would be facing in
their day-to-day work. Over the following years. the directors began to realize that the Simulator would be valuable
to a much wider range of physicians in training. Several departments, including Radiology and Emergency Medicine,
have realized the potential of this learning experience and have integrated the Simulator sessions into their residency
training programs.
In 1998, the directors at CMS expanded the curriculum to include third year medical students. To demonstrate the
value of Simulator-oriented skills to students at an earlier stage of professional development. the CMS staff recruited
forty-cight third year medical students in their surgical clerkship at the Beth Israel-Deaconess Medical Center to take
part in one simulator session. Subsequently, fifteen students agreed to take part in three additional simulations.
During our first Simulator experience, small teams of us were presented with a patient, Mr. Martin, who had
multiple problems relating to volume status. Our pulses raced, even as Mr. Martin's became impalpable. and we
were frankly overwhelmed. We could not efficiently collect information. We did not effectively communicate with
each other. We failed to recognize and utilize our resources. We could not prioritize or delegate the tasks necessary to
care for Mr. Martin adequately. Ultimately, patient care suffered.
DEC-21-1999 17:09
HMS
We were fortunate that our Simulator education did not end with Mr. Martin's impending demise. Over the
subsequent three sessions, we gained competence and confidence. The CMS staff presented us with a framework for
successful event management. They taught us multiple techniques for communicating effectively during high stress
situations. They emphasized the importance of actively defining task assignments for the efficient use of time and
resources. They helped us develop techniques for managing a chaotic and volatile environment.
Using this framework. the life-threatening issues that had bombarded and paralyzed us in the initial session became a
series of manageable events. We discovered we could enter daunting situations calmly, devise a coherent strategy as a
team, and move forward with a flexible plan of action. Though we worked with different team members during each
session, our individual and team effectiveness tangibly improved: By the last sessions, we were working together as
effective clinical care teams. We also began to confidently integrate our medical knowledge into these stressful
clinical settings. In fact, our experience served as a perfect bridge between classroom learning and clinical education.
The Simulator's real-life scenarios demanded rapid, coherent demonstration of our ability to: (1) apply
pathophysiology to a clinical situation; (2) generate differential diagnoses; and (3) choose optimum treatment. The
debriefing sessions that followed each scenario solidified the connections between theory and practice. It is
unfortunately too rare in the first year of clinical education for students to appreciate their own increasing
competence. In contrast, these simulator sessions generated immediate feedback that both demonstrated progress and
inspired further growth.
The Simulator stands out as our most important educational adventure at Harvard Medical School. We feel
empowered by the experience. We now have a framework for clinical event management that will benefit us. our
colleagues, and most important, our patients. Already we are beginning to approach acute clinical situations with an
organized idea of how to manage them. As we move into our careers. our medical knowledge will increasingly
complement the management strategies that we have learned. We cannot imagine entering the profession without
this structure.
We urge the medical school to increase support for the Center for Medical Simulation and to help integrate their
work into the medical school curriculum. The Simulator approach represents a logical extension of the case-based,
cooperative learning method at HMS. The event management skills are teachable, learnable. and applicable to many
situations. The opportunity to apply our knowledge and then to reflect upon the results was invaluable. Ultimately,
we hope that every medical student will have this opportunity to learn in such an exciting, enduring, and rewarding
way.
Thank you for your time and consideration. Please feel free to contact us with any questions.
Sincerely.
areah And
Kgle Ench
PAUL BAUM
Arash Anoshiravani, HMS IV
Kayla Zomlefer. HMS TV
Paul Baum, HMS IV
(617) 424-1509
(781)641-0360
Kristen Bredin
Kristen Breslin, HMS IV
Alexis Falicov, HMS IV
Levi Garraway, HMS IV
Ruckel Guerleyer Rosorday
Inc! Has
We Andrew Kapustin, HMS [V
Rachel Greenberger-Rosovsky, HMS IV Joan Han, HMS IV
De A.Mar
David Mark. HMS IV
GaiD. Craig Norquist, Norgan HMS IV
Pankaj Merchia
Pankaj Merchia. MD
Meena Ramakrishnan, HMS IV
Todd Thomsen, HMS IV
Aaron Sodickson. HMS IV
TOTAL P.34
THE NEW YORKER, Feb. 1, 1999
ANNALS OF MEDICINE
WHEN DOCTORS MAKE MISTAKES
The real problem isn't how to stop bad doctors from harming, even
killing, their patients. It's how to prevent good doctors from doing so.
BY ATUL GAWANDE
I-CRASH VICTIM
AT 2 A.M. on a crisp Friday in winter, I was in sterile gloves and
gown, pulling a teen-age knifing victim's abdomen open, when my
pager sounded. "Code Trauma, three minutes," the operating-room
nurse said, reading aloud from my pager display. This meant that an
ambulance would be bringing another trauma patient to the hospital
momentarily, and, as the surgical resident on duty for emergencies, I
would have to be present for the patient's arrival. I stepped back
from the table and took off my gown. Two other surgeons were
working on the knifing victim: Michael Ball, the attending (the staff
surgeon in charge of the case), and David Hernandez, the chief
resident (a general surgeon in his last of five years of training).
Ordinarily, these two would have come later to help with the trauma,
but they were stuck here. Ball, a dry, imperturbable forty-two year-
old Texan, looked over to me as I headed for the door. "If you run
into any trouble, you call. and one of us will peel away," he said.
I did run into trouble. In telling this story, I have had to
change significant details about what happened (including the names
of the participants and aspects of my role), but I have tried to stay as
close to the actual events as I could while protecting the patient,
myself, and the rest of the staff. The way that things go wrong in
medicine is normally unseen and, consequently, often misunderstood.
Mistakes do happen. We think of them as aberrant; they are
anything but. The emergency room was one floor up, and, taking the
stairs two at a time, I arrived just as the emergency medical
technicians wheeled in a woman who appeared to be in her thirties
and to weigh more than two hundred pounds. She lay motionless on
a hard orange plastic spinal board-eyes closed, skin pale, blood
running out of her nose. A nurse directed the crew into Trauma Bay
1, an examination room outfitted like an OR, with green tiles on the
wall, monitoring devices, and space for portable X-ray equipment.
We lifted her onto the bed and then went to work. One nurse began
cutting off the woman's clothes. Another took vital signs. A third
inserted a largé-bore intravenous line into her right arm. A surgical
intern put a Foley catheter into her bladder. The emergency-
medicine attending was Samuel Johns, a gaunt, Ichabod Crane-like
man in his fifties. He was standing to one side with his arms crossed,
observing, which was a sign that I could go ahead and take charge.
If you're in a hospital, most of the "moment to moment'
doctoring you get is from residents-physicians receiving specialty
training and a small income in exchange for their labor. Our
responsibilities depend on our level of training, but we're never
entirely on our own: there's always an attending, who oversees our
decisions. That night, since Johns was the attending and was
responsible for the patient's immediate management, I took my lead
from him. But he wasn't a. surgeon, and so he relied on me for
surgical expertise. "What's the story?" I asked. An E.M.T. rattled off
the details: "Unidentified white female unrestrained driver in high-
speed rollover. Ejected from the car. Found unresponsive to pain.
Pulse a hundred, B.P. a hundred over sixty, breathing at thirty on her
own
" As he spoke, I began examining her. The first step in caring
for a trauma patient is always the same. It doesn't matter if a person
has been shot eleven times or crushed by a truck or burned in a
kitchen fire. The first thing you do is make sure that the patient can
breathe without difficulty. This woman's breaths were shallow and
rapid. An oximeter, by means of a sensor placed on her finger,
measured the oxygen saturation of her blood. The "°2 sat" is normally
more than ninety-five per cent for a patient breathing room air. The
woman was wearing a face mask with oxygen turned up full blast,
and her sat was only ninety per cent. "She's not oxygenating well," I
Physicians are meeting behind closed doors in hospitals all over the
country to talk candidly about their sometimes deadly errors.
THE NEW Yorker, February 1, 1999
announced in the flattened-out, wake-me-up-when-something-
interesting-happens tone that all surgeons have acquired by about
three months into residency. With fingers, I verified that there
wasn't any object in her mouth that would obstruct airway; with a
stethoscope, I confirmed that neither lung had collapsed. I hold of a
bag mask, pressed its clear facepiece over her nose and mouth, and
squeezed the bellows, a kind of balloon with a one-way valve,
shooting a litre of into her with each compression. After a minute or
so, her oxygen came up to a comfortable ninety-eight per cent. She
obviously needed our help with breath,. "Let's tube her," I said. That
meant putting a tube down through her vocal cods and into her
trachea, which would insure a clear airway and allow for mechanical
ventilation.
Johns, the attending, wanted to do the intubation. He picked up
a Mac 3 laryngoscope, a standard but fairly primitive looking L-
shaped metal instrument for prying open the mouth and throat, and
slipped the shoehornlike blade deep into mouth and down to her
larynx Then he yanked the handle up toward the ceiling to pull her
tongue out of the way, her mouth and throat, and reveal the vocal
cords, which sit like fleshy tent at the entrance to the trachea. The
patient didn't wince or gag: she was still cold.
"Suction!" he called. "I can't see a thing."
He sucked out about a cup of blood and clot. Then he picked up
the endotracheal tube-a clear rubber pipe about the diameter of an
index finger and three times as long-and tried to guide it between
her cords. After a minute, her sat started to fall.
"You're down to seventy per cent," nurse announced. Johns
kept struggling with the tube, trying to push it in, but it banged
vainly against the cords. The patient's lips began to turn blue.
"Sixty per cent," the nurse said.
Johns pulled everything out of the patient's mouth and fitted
the bag mask back on. The oximeter's luminescent-green readout
hovered at sixty for a moment and then rose steadily, to ninety-
seven per cent. After a few minutes, he took the mask off and again
tried to get the tube in. There was more blood, and there may have
been some swelling, too: all the poking down the throat was probably
not helping. The sat fell to sixty per cent. He pulled out and bagged
her until she returned to ninety-five per cent.
When you're having trouble getting the tube in, the next step is
to get specialized expertise. "Let's call anesthesia," I said, and Johns
agreed In the meantime, I continued to follow the standard trauma
protocol: completing the examination and ordering fluids, lab tests,
and X-rays. Maybe five minutes passed as I worked.
The patient's Sats drifted down to ninety-two per cent-not a
dramatic change but definitely not normal for a patient who is being
manually ventilated. I checked to see if the sensor had slipped off
her finger. It hadn't. "Is the oxygen up full blast?" I asked a nurse.
'It's up all the way," she said.
listened again to the patient's lungs- no collapse. "We've got
to get her tubed," Johns said. He took off the oxygen mask and tried
again.
Somewhere in my mind, I must have been aware of the
possibility that her airway was shutting down because of vocal cord
swelling or blood. If it was, and we were unable to get a tube in, then
the only chance she'd have to survive would be an emergency
trachepstomy: cutting a hole in her neck and inserting a breathing
tube into her trachea. Another attempt to intubate her might even
trigger a spasm of the cords and a sudden closure of the
airway-which is exactly what did happen.
If I had actually thought this far along, I would have
recognized how ill-prepared I was to do an emergency "trache." Of
the people in the room, it's true, I had the most experience doing
trachepstomies, but that wasn't saying much. I had been the assistant
surgeon in only about half a dozen, and all but one of them had been
non-emergency cases, employing techniques that were not designed
for speed. The exception was a practice emergency trache I had done
on a goat. I should have immediately called Dr. Ball for backup. I
should have got the trache equipment out-lighting, suction, sterile
instruments-just in case. Instead of hurrying the effort to get the
patient intubated because of a mild drop in saturation, I should have
asked Johns to wait until I had help nearby. I might even have
recognized that she was already losing her airway. Then I could have
grabbed a knife and started cutting her a tracheostomy while things
were still relatively stable and I had time to proceed slowly. But for
whatever reasons-hubris, inattention, wishful thinking, hesitation, or
the uncertainty of the moment-I let the opportunity pass.
Johns hunched over the patient, intently trying to insert the
tube through her vocal cords. When her sat once again dropped into
the sixties, he stopped and put the mask back on. We stared at the
monitor. The numbers weren't coming up. Her lips were still blue.
Johns squeezed the bellows harder to blow more oxygen in.
I'm getting resistance," he said.
The realization crept over me: this was a disaster. "Damn it,
we've lost her airway," I said. "Trache kit! Light! Somebody call down
to O.R 25 and get Ball up here!"
People were suddenly scurrying everywhere. I tried t not let
panic take hold. I told the surgical intern to get a sterile gown and
gloves on. I took a bactericidal solution off a shelf and dumped a
whole bottle of yellow-brown liquid on the patient's neck. A nurse
unwrapped the tracheostomy kit - a sterilized set of drapes and
instruments. I pulled on a gown and an new pair of gloves while
trying to think through the steps. This is simple, really, I tried to tell
myself, At the base of the thyroid cartilage, the Adam's apple, is a
little gap in which you find a thin, fibrous covering called the
cricothyroid membrane. Cut through that and-voila! You're in the
trachea. You slip through the hole a four-inch plastic tube shaped
like a plumber's elbow joint, hook it up to oxygen and a ventilator,
and she's all set. Anyway, that was the theory.
I threw some drapes over her body, leaving the neck exposed.
It looked as thick as a tree. I felt for the bony prominence of the
thyroid cartilage. But I couldn't feel anything through the rolls of fat.
I was beset by uncertainty-where should I cut? should I make a
horizontal or a vertical incision?-and I hated myself for it. Surgeons
never dithered, and I was dithering.
'I need better light," I said.
Someone was sent out to look for one.
'Did anyone get Ball?" I asked. It wasn't exactly an inspiring
question
"He's on his way," a nurse said.
There wasn't time to wait. Four minutes without oxygen would
lead to permanent brain damage, if not death. Finally, I took the
scalpel and cut. I just cut. I made a three-inch left-to-right swipe
across the middle of the neck, following the procedure I'd learned for
elective cases. I figured that if I worked through the fat I might be
able to find the membrane in the wound. Dissecting down with
scissors while the intern held the wound open with retractors, I hit a
vein. It didn't let loose a lot of blood, but there was enough to fill the
wound: I couldn't see anything. The intern put a finger on the
bleeder. I called for suction. But the suction wasn't working: the tube
was clogged with the clot from the intubation efforts. "Somebody get
some new tubing," I said. "And where's the light?"
Finally, an orderly wheeled in a tall overhead light, plugged it
in, and flipped on the switch. It was still too dim; I could have done
better with a flashlight.
wiped up the blood with gauze, then felt around in the wound
with my fingertips. This time, I thought I could feel the hard ridges
of the thyroid cartilage and, below it, the slight gap of the
cricothyroid membrane, though I couldn't be sure. I held my place
with my left hand.
James O'Connor, a silver-haired, seen-it-all anesthesiologist,
came into the room. Johns gave him a quick rundown on the patient
and let him take over bagging her.
Holding the scalpel in my right hand like a pen, I stuck the
blade down into the wound at the spot where I thought the thyroid
cartilage was. With small, sharp strokes-working blindly, because of
the blood and the poor light-I cut down through the overlying fat
and tissue until I felt the blade scrape against the almost bony
cartilage. I searched with the tip of the knife, walking it along until I
felt it reach a gap. I hoped it was the cricothyroid membrane, and
pressed down firmly. Then I felt the tissue suddenly give, and I cut
an inch-long opening. When I put my index finger into it, it felt as if
I were prying open the jaws of a stiff clothespin. Inside, I thought I
felt open space. But where were the sounds of moving air that I
expected? Was this deep enough? Was I even in the right place?
"I think I'm in," I said, to reassure myself as much as anyone
else.
"I hope so," O'Connor said. "She doesn't have much longer."
I took the tracheostomy tube and tried to fit it in, but
something seemed to be blocking it. I twisted it and turned it, and
finally jammed it in. Just then, Ball, the surgical attending, arrived.
He rushed up to the bed and leaned over for a look. "Did you get it?"
he asked. I said that I thought so. The bag mask was plugged onto
the open end of the trache tube. But when the bellows were
compressed the air just gurgled out of the wound. Ball quickly put on
gloves and a gown.
"How long has she been without an airway?" he asked.
"I don't know. Three minutes."
Ball's face hardened as he registered that he had about a
minute in which to turn things around. He took my place and
summarily pulled out the trache tube. "God, what a mess," he said. "I
can't see a thing in this wound. I don't even know if you're in the
right place. Can we get better light and suction?" New suction tubing
was found and handed to him. He quickly cleaned up the wound and
went to work.
The patient's sat had dropped so low that the oximeter couldn't
detect it anymore. Her heart rate began slowing down-first to the
sixties and then to the forties. Then she lost her pulse entirely. I put
my hands together on her chest, locked my elbows, leaned over her,
and started doing chest compressions.
Ball looked up from the patient and turned to O'Connor. "I'm
not going to get her an airway in time," he said. "You're going to have
to try from above." Essentially, he was admitting my failure. Trying
an oral intubation again was pointless-just something to do instead
of watching her die. I was stricken, and concentrated on doing chest
compressions, not looking at anyone. It was over, I thought.
And then, amazingly, O'Connor: "I'm in." He had managed to slip
a pediatricsize endotracheal tube through the vocal cords. In thirty
seconds, with oxygen being manually ventilated through the tube,
her heart was back, racing at a hundred and twenty beats a minute.
Her sat registered at sixty and then climbed. Another thirty seconds
and it was at ninety-seven per cent. All the people in the room
exhaled, as if they, too, had been denied their breath. Ball and I said
little except to confer about the next steps for her. Then he went
back downstairs to finish working on the stabwound patient still in
the O.R.
We eventually identified the woman, whom I'll call Louise
Williams; she was thirty-four years old and lived alone in a nearby
suburb. Her alcohol level on arrival had been three times the legal
limit, and had probably contributed to her unconsciousness. She had
a condussion, several lacerations, and significant soft-tissue damage.
But X-rays and scans revealed no other injuries from the crash. That
night, Ball and Hernandez brought her to the O.R. to fit her with a
proper tracheostomy. When Ball came out and talked to family
members, he told them of the dire condition she was in when she
arrived, the difficulties "we" had had getting access to her airway,
the disturbingly long period of time that she had gone without
oxygen, and thus his uncertainty about how much brain function she
8
still possessed. They listened without protest; there was nothing for
them to do but wait.
II-THE BANALITY OF ERROR
To much of the public-and certainly to lawyers and the
media-medical error is a problem of bad physicians. Consider some
other surgical mishaps. In one, a general surgeon left a large metal
instrument in a patient's abdomen, where it tore through the bowel
and the wall of the bladder. In another, a cancer surgeon biopsied
the wrong part of a woman's breast and thereby delayed her
diagnosis of cancer for months. A cardiac surgeon skipped a small
but key step during a heart-valve operation, thereby killing the
patient. A surgeon saw a man racked with abdominal pain in the
emergency room and, without taking a C.T. scan, assumed that the
man had a kidney stone; eighteen hours later, a scan showed a
rupturing abdominal aortic aneurysm, and the patient died not long
afterward.
How could anyone who makes a mistake of that magnitude be
allowed to practice medicine? We call such doctors "incompetent,"
"unethical," and "negligent." We want to see them punished. And so
we've wound up with the public system we have for dealing with
error: malpractice lawsuits, media scandal, suspensions, firings.
There is, however, a central truth in medicine that complicates
this tidy vision of misdeeds and misdoers: all doctors make terrible
mistakes. Consider the cases I've just described. I gathered them
simply by asking respected surgeons I know-surgeons at top
medical schools-to tell me about mistakes they had made just in the
past year. Every one of them had a story to tell.
In 1991, The New England Journal of Medicine published a
series of landmark papers from a project known as the Harvard
Medical Practice Study-a review of more than thirty thousand
hospital admissions in New York State. The study found that nearly
four per cent of hospital patients suffered complications from
treatment which prolonged their hospital stay or resulted in
disability or death, and that two-thirds of such complications were
due to errors in care. One in four, or one per cent of admissions,
involved actual negligence. It was estimated that, nationwide, a
hundred and twenty thousand patients die each year at least partly
as a result of errors in care. And subsequent investigations around
the country have confirmed the ubiquity of error. In one small study
of how clinicians perform when patients have a sudden cardiac
arrest, twenty-seven of thirty clinicians made an error in using the
defibrillator; they may have charged it incorrectly or lost valuable
time trying to figure out how to work a particular model. According
to a 1995 study, mistakes in administering drugs-giving the wrong
drug or the wrong dose, say-occur, on the average, about once for
every hospital admission, mostly without ill effects, but one per cent
of the time with serious consequences.
If error were due to a subset of dangerous doctors, you might
expect malpractice cases to be concentrated among a small group, but
in fact they follow a uniform, bell-shaped distribution. Most surgeons
are sued at least once in the course of their careers. Studies of
specific types of error, too, have found that repeat offenders are not
the problem. The fact is that virtually everyone who cares for
hospital patients will make serious mistakes, and even commit acts
of negligence, every year. For this reason, doctors are seldom
outraged when the press reports yet another medical horror story.
They usually have a different reaction: That could be me. The
important question isn't how to keep bad physicians from harming
patients; it's how to keep good physicians from harming patients.
Medical-malpractice suits are a remarkably ineffective remedy.
Troyen Brennan, a Harvard professor of law and public health, points
out that research has consistently failed to find evidence that
litigation reduces medical-error rates. In part, this may be because
the weapon is so imprecise. Brennan led several studies following up
on the patients in the Harvard Medical Practice Study. He found that
fewer than two per cent of the patients who had received
substandard care ever filed suit. Conversely, only a small minority
among the patients who did sue had in fact been the victims of
negligent care. And a patient's likelihood of winning a suit depended
primarily on how poor his or her outcome was, regardless of whether
that outcome was caused by disease or unavoidable risks of care.
The deeper problem with medical malpractice suits, however,
is that by demonizing errors they prevent doctors from
acknowledging and discussing them publicly. The tort system makes
adversaries of patient and physician, and pushes each to offer a
heavily slanted version of events. When things go wrong, it's almost
impossible for a physician to talk to a patient honestly about
mistakes. Hospital lawyers warn doctors that, although they must, of
course, tell patients about complications that occur, they are never to
intimate that they were at fault, lest the "confession" wind up in
court as damning evidence in a black-and-white morality tale. At
most, a doctor might say, "I'm sorry that things didn't go as well as
we had hoped."
There is one place, however, where doctors can talk candidly
about their mistakes, if not with patients, then at least with one
another. It is called the Morbidity and Mortality Conference- or,
more simply, M. &M.-and it takes place, usually once a week, at
nearly every academic hospital in the country. This institution
survives because laws protecting its proceedings from legal
discovery have stayed on the books in most states, despite frequent
challenges. Surgeons, in particular, take the M. &M. seriously. Here
they can gather behind closed doors to review the mistakes,
complications, and deaths that occurred on their watch, determine
responsibility, and figure out what to do differently next time.
Ш-SHOW AND TELL
AT my hospital, we convene every Tuesday at five o'clock in a steep,
plush amphitheater lined with oil portraits of the great doctors
whose achievements we're meant to live up to. All surgeons are
expected to attend, from the interns to the chairman of surgery;
we're also joined by medical students doing their surgery "rotation."
An M. & M. can include almost a hundred people. We file in, pick up
a photocopied list of cases to be discussed, and take our seats. The
front row is occupied by the most senior surgeons: terse, serious
men, now out of their scrubs and in dark suits, lined up like a panel
of senators at a hearing. The chairman is a leonine presence in the
seat closest to the plain den podium from which each case is
presented. In the next few rows are the remaining surgical
attendings; these tend to be younger, and several of them are
women. The chief residents have put on long white coats and usually
sit in the side rows. I join the mass of other residents, all of us in
short white coats and green scrub pants, occupying the back rows.
For each case, the chief resident from the relevant
service-cardiac, vascular, trauma, and so on-gathers the
information, takes the podium, and tells the story. Here's a partial list
of cases from a typical week (with a few changes to protect
confidentiality): a sixty-eight-year old man who bled to death after
heartvalve surgery; a forty-seven-year-old woman who had to have
a reoperation because of infection following an arterial bypass done
in her left leg; a forty-four-year-old woman who had to have bile
drained from her abdomen after gallbladder surgery; three patients
who had to have reoperations for bleeding following surgery; a sixty-
three-year-old man who had a cardiac arrest following heart bypass
surgery; a sixty-six-year-old woman whose sutures suddenly gave
way in an abdominal wound and nearly allowed her intestines to
spill out. Ms. William's case, my failed tracheostomy, was just one
case on a list like this. David Hernandez, the chief trauma resident,
had subsequently reviewed the records and spoken to me and others
involved. When the time came, it was he who stood up front and
described what had happened.
Hernandez is a tall, rollicking, good old boy who can tell a yarn,
but M.& M. presentations are bloodless and compact. He said
something like: "This was a thirty-four-year-old female unrestrained
driver in a high-speed rollover. The patient apparently had stable
vitals at the scene but was unresponsive, and brought in by
ambulance unintubated. She was G.C.S. 7 on arrival." G.C.S. stands for
the Glasgow Coma Scale, which rates the severity of head injuries,
from three to fifteen. G.C.S.7 is in the comatose range. "Attempts to
intubate were made without success in the E.R. and may have
contributed to airway closure. A cricothyroidotomy was attempted
without success."
These presentations can be awkward. The chief residents, not
the attendings, determine which cases to report. That keeps the
attendings honest-no one can cover up mistakes-but it puts the
chief residents, who are, after all, underlings,
AN OLD-FASHIONED HIERARCHY
in a delicate position. The successful M. &M. presentation inevitably
involves a certain elision of detail and a lot of passive verbs. No one
screws up a cricothyroidotomy. Instead, "a cricothyroidotomy was
attempted without success." The message, however, was not lost on
anyone.
Hernandez continued, "The patient arrested and required
cardiac compressions. Anesthesia was then able to place a pediatric
E.T. tube and the patient recovered stable vitals. The tracheostomy
was then completed in the O.R."
So Louise Williams had been deprived of oxygen long enough to
go into cardiac arrest, and everyone knew that meant she could
easily have suffered a disabling stroke or been left a vegetable.
Hernandez concluded with the fortunate aftermath: "Her
workup was negative for permanent cerebral damage or other major
injuries. The tracheostomy was removed on Day 2. She was
discharged to home in good condition on Day 3." To the family's great
relief, and mine, she had woken up in the morning a bit woozy but
hungry, alert, and mentally intact. In a few weeks, the episode would
heal to a scar.
But not before someone was called to account. A front-row
voice immediately thundered, "What do you mean, 'A
cricothyroidotomy was attempted without success?" I sank into my
seat, my face hot.
"This was my case," Dr. Ball volunteered from the front row. It
is how every attending begins, and that little phrase contains a world
of surgical culture. For all the talk in business schools and in
corporate America about the virtues of "flat organizations," surgeons
maintain an old-fashioned sense of hierarchy. When things go wrong,
the attending is expected to take full responsibility. It makes no
difference whether it was the resident's hand that slipped and
lacerated an aorta; it doesn't matter whether the attending was at
home in bed when a nurse gave a wrong dose of medication. At the
M. &M., the burden of responsibility falls on the attending.
Ball went on to describe the emergency attending's failure to
intubate Williams and his own failure to be at her bedside when
things got out of control. He described the bad lighting and her
extremely thick neck, and was careful to make those sound not like
excuses but merely like complicating factors. Some attendings shook
their heads in sympathy. A couple of them asked questions to clarify
certain details. Throughout, Ball's tone was objective, detached. He
had the air of a CNN newscaster describing unrest in Kuala Lumpur.
As always, the chairman, responsible for the over-all quality of
our surgery service, asked the final question. What, he wanted to
know, would Ball have done differently? Well, Ball replied, it didn't
take long to get the stab-wound patient under control in the O.R., so
he probably should have sent Hernandez up to the E.R. at that point
or let Hernandez close the abdomen while he himself came up.
People nodded. Lesson learned. Next case.
At no point during the M. &M. did anyone question why I had
not called for help sooner or why I had not had the skill and
knowledge that Williams needed. This is not to say that my actions
were seen as acceptable. Rather, in the hierarchy, addressing my
errors was Ball's role. The day after the disaster, Ball had caught me
in the hall and taken me aside. His voice was more wounded than
angry as he went through my specific failures. First, he explained, in
an emergency tracheostomy it might have been better to do a
vertical neck incision; that would have kept me out of the blood
vessels, which run up and down-something I should have known at
least from my reading. I might have had a much easier time getting
her an airway then, he said. Second, and worse to him than mere
ignorance, he didn't understand why I hadn't called him when there
were clear signs of airway trouble developing. I offered no excuses. I
promised to be better prepared for such cases and to be quicker to
ask for help. Even after Ball had gone down the fluorescent-lit
hallway, I felt a sense of shame like a burning ulcer. This was not
guilt: guilt is what you feel when you have done something wrong.
What I felt was shame: was what was wrong. And yet I also knew
that a surgeon can take such feelings too far. It is one thing to be
aware of one's limitations. It is another to be plagued by self-doubt.
One surgeon with a national reputation told me about an abdominal
operation in which he had lost control of bleeding while he was
removing what turned out to be a benign tumor and the patient had
died. "It was a clean kill," he said. Afterward, he could barely bring
himself to operate. When he did operate, he became tentative and
indecisive. The case affected his performance for months.
Even worse than losing self-confidence, though, is reacting
defensively. There are surgeons who will see faults everywhere
except in themselves. They have no questions and no fears about
their abilities. As a result, they learn nothing from their mistakes
and know nothing of their limitations. As one surgeon told me, it is a
rare but alarming thing to meet a surgeon without fear. "If you're not
a little afraid when you operate," he said, "you're bound to do a
patient a grave disservice."
The atmosphere at the M. &M. is meant to discourage both
attitudes- self-doubt and denial-for the M. &M. is a cultural ritual
that inculcates in surgeons a "correct" view of mistakes. "What would
you do differently?" a chairman asks concerning cases of avoidable
complications. "Nothing" is seldom an acceptable answer.
In its way, the M. & M. is an impressively sophisticated and
human institution. Unlike the courts or the media, it recognizes that
human error is generally not something that can be deterred by
punishment. The M. & M. sees avoiding error as largely a matter of
will-of staying sufficiently informed and alert to anticipate the
myriad ways that things can go wrong and then trying to head off
each potential problem before it happens. Why do things go wrong?
Because, doctors say, making them go right is hard stuff. It isn't
damnable that an error occurs, but there is some shame to it. In fact,
the M. & M.'s ethos can seem paradoxical. On the one hand, it
reinforces the very American idea that error is intolerable. On the
other hand, the very existence of the M. &M., its place on the weekly
schedule, amounts to an acknowledgment that mistakes are an
inevitable part of medicine.
BUT why do they happen so often? Lucian Leape, medicine's leading
expert on eΓΓoΓ, points out that many other industries-whether the
task is manufacturing semiconductors or serving customers at the
Ritz-Carlton-simply wouldn't countenance error rates like those in
hospitals. The aviation industry has reduced the frequency of
operational errors to one in a hundred thousand flights, and most of
those errors have no harmful consequences. The buzzword at General
Electric these days is "Six Sigma," meaning that its goal is to make
product defects so rare that in statistical terms they are more than
six standard deviations away from being a matter of chance-almost
a ond-in-a-million occurrence.
Of course, patients are far more complicated and idiosyncratic
than airplanes, and medicine isn't a matter of delivering a fixed
product or even a catalogue of products; it may well be more
complex than just about any other field of human endeavor. Yet
everything we've learned in the past two decades-from cognitive
psychology, from "human factors" engineering. from studies of
disasters like Three Mile Island and Bhopal-has yielded the same
insights: not only do all human beings err but they err frequently
and in predictable, patterned ways. And systems that do not adjust
for these realities can end up exacerbating rather than eliminating
error.
The British psychologist James Reason argues, in his book
"Human Error," that our propensity for certain types of error is the
price we pay for the brain's remarkable ability to think and act
intuitively-to sift quickly through the sensory information that
constantly bombards us without wasting time trying to work through
every situation anew. Thus systems that rely on human perfection
present what Reason calls "latent errors"-errors waiting to happen.
Medicine teems with examples. Take writing out a prescription, a
rote procedure that relies on memory and attention, which we know
are unreliable. Inevitably, a physician will sometimes specify the
wrong dose or the wrong drug. Even when the prescription is written
correctly, there's a risk that it will be misread. (Computerized
ordering systems can almost eliminate errors of this kind, but only a
small minority of hospitals have adopted them.) Medical equipment,
which manufacturers often build without human operators in mind,
is another area rife with latent errors: one reason physicians are
bound to have problems when they use cardiac defibrillators is that
the devices have no standard design. You can also make the case that
onerous workloads, chaotic environments, and inadequate team
communication all represent latent errors in the system.
James Reason makes another important observation: disasters
do not simply occur; they evolve. In complex systems, a single failure
rarely leads to harm. Human beings are impressively good at
adjusting when an error becomes apparent, and systems often have
built-in defenses. For example, pharmacists and nurses routinely
check and counter-check physicians' orders. But errors do not always
become apparent, and backup systems themselves often fail as a
result of latent errors. A pharmacist forgets to check one of a
thousand prescriptions. A machine's alarm bell malfunctions. The one
attending trauma surgeon available gets stuck in the operating room.
When things go wrong, it is usually because a series of failures
conspire to produce disaster.
The M. &M. takes none of this into account. For that reason,
many experts see it as a rather shabby approach to analyzing error
DEC-21-1999 17:01
HI'IS
and improving performance in medicine. It isn't enough to ask what
a clinician could or should have done differently so that he and
others may learn for next time. The doctor is often only the final
actor in a chain of events that set him or her up to fail. Error experts,
therefore, believe that it's the process, not the individuals in it, which
requires closer examination and correction. In a sense, they want to
industrialize medicine. And they can already claim one success story:
the specialty of anesthesiology, which has adopted their precepts and
seen extraordinary results.
IV-NEARLY PERFECT
AT the center of the emblem of the American Society of
Anesthesiologists is a single word: "Vigilance." When you put a
patient to sleep under general anesthesia, you assume almost
complete control of the patient's body. The body is paralyzed, the
brain rendered unconscious, and machines are hooked up to control
breathing, heart rate, blood pressure-all the vital functions. Given
the complexity of the machinery and of the human body, there are a
seemingly infinite number of ways in which things can go wrong,
even in minor surgery. And yet anesthesiologists have found that if
problems are detected they can usually be solved. In the nineteen-
forties, there was only one death resulting from anesthesia in every
twenty-five hundred operations, and between the nineteen sixties
and the nineteen-eighties the rate had stabilized at one or two in
every ten thousand operations.
But Ellison (Jeep) Pierce had always regarded even that rate as
unconscionable. From the time he began practicing, in 1960, as a
young anesthesiologist out of North Carolina and the University of
Pennsylvania, he had maintained a case file of details from all the
deadly anesthetic accidents he had come across or participated in.
But it was one case in particular that galvanized him. Friends of his
had taken their eighteen-year-old daughter to the hospital to have
her wisdom teeth pulled, under general anesthesia. The
anesthesiologist inserted the breathing tube into her esophagus
instead of her trachea, which is a relatively common mishap, and
then failed to spot the error, which is not. Deprived of oxygen, she
died within minutes. Pierce knew that a one-in-ten-thousand death
rate, given that anesthesia was administered in the United States an
estimated thirty-five million times each year, meant thirty-five
DEC-21-1999
hundred avoidable deaths like that one.
In 1982, Pierce was elected vice-president of the American
Society of Anesthesiologists and got an opportunity to do something
about the death rate. The same year, ABC's "20/20" aired an expose
that caused a considerable stir in his profession. The segment began,
"If you are going to go into anesthesia, you are going on a long trip,
and you should not do it if you can avoid it in any way. General
anesthesia [is] safe most of the time, but there are dangers from
human error, carelessness, and a critical shortage of
anesthesiologists. This year, six thousand patients will die or suffer
brain damage." The program presented several terrifying cases from
around the country. Between the small crisis that the show created
and the sharp increases in physicians' malpractice-insurance
premiums at that time, Pierce was able to mobilize the Society of
Anesthesiologists around the problem of error.
He turned for ideas not to a physician but to an engineer
named Jeffrey Cooper, the lead author of a groundbreaking 1978
paper entitled "Preventable Anesthesia Mishaps: A Study of Human
Factors." An unassuming, fastidious man, Cooper had been hired in
1972, when he was twenty-six years old, by the Massachusetts
General Hospital bioengineering unit, to work on developing
machines for anesthesiology researchers. He gravitated toward the
operating room, however, and spent hours there observing the
anesthesiologists, and one of the first things he noticed was how
poorly the anesthesia machines were designed. For example, a
clockwise turn of a dial decreased the concentration of potent
anesthetics in about half the machines but increased the
concentration in the other half. He decided to borrow a technique
called "critical incident analysis"-which had been used since the
nineteen-fifties to analyze mishaps in aviation-in an effort to learn
how equipment might be contributing to errors in anesthesia. The
technique is built around carefully conducted interviews, designed to
capture as much detail as possible about dangerous incidents: how
specific accidents evolved and what factors contributed to them. This
information is then used to look for patterns among different cases.
Getting open, honest reporting is crucial. The Federal Aviation
Administration has a formalized system for analyzing and reporting
dangerous aviation incidents, and its enormous success in improving
airline safety rests on two cornerstones. Pilots who report an incident
within ten days have automatic immunity from punishment, and the
reports go to a neutral, outside agency, NASA, which has no interest
in using the information against individual pilots. For Jeffrey Cooper,
it was probably an advantage that he was an engineer, and not a
physician, SO that anesthesiologists regarded him as a discreet,
unthreatening interviewer.
The result was the first in-depth, scientific look at errors in
medicine. His
detailed analysis of three hundred and fifty-nine errors provided a
view of the profession unlike anything that had been seen before.
Contrary to the prevailing assumption that the start of anesthesia
("takeoff") was the most dangerous part, anesthesiologists learned
that incidents tended to occur in the middle of anesthesia, when
vigilance waned. The most common kind of incident involved errors
in maintaining the patient's breathing, and these were usually the
result of an undetected disconnection or misconnection of the
breathing tubing, mistakes in managing the airway, or mistakes in
using the anesthesia machine. Just as important, Cooper enumerated
a list of contributory factors, including inadequate experience,
inadequate familiarity with equipment, poor communication among
team members, haste, inattention, and fatigue.
The study provoked widespread debate among
anesthesiologists, but there was no concerted effort to solve the
problems until Jeep Pierce came along. Through the anesthesiology
society at first, and then through a foundation that he started, Pierce
directed funding into research on how to reduce the problems Cooper
had identified, sponsored an international conference to gather ideas
from around the world, and brought anesthesia-machine designers
into safety discussions.
It all worked. Hours for anesthesiology residents were
shortened. Manufacturers began redesigning their machines with
fallible human beings in mind. Dials were standardized to turn in a
uniform direction; locks were put in to prevent accidental
administration of more than one anesthetic gas; controls were
changed so that oxygen delivery could not be turned down to zero.
Where errors could not be eliminated directly, anesthesiologists
began looking for reliable means of detecting them earlier. For
example, because the trachea and the esophagus are so close
together, it is almost inevitable that an anesthesiologist will
sometimes put the breathing tube down the wrong pipe.
Anesthesiologists had always checked for this by listening with a
stethoscope for breath sounds over both lungs. But Cooper had
turned up a surprising number of mishaps-like the one that befell
the daughter of Pierce's friends-involving undetected esophageal
intubations. Something more effective was needed. In fact, monitors
that could detect this kind of error had been available for years, but,
in part because of their expense, relatively few anesthesiologists
used them. One type of monitor could verify that the tube was in the
trachea by detecting carbon dioxide being exhaled from the lungs.
Another type, the pulse oximeter, tracked blood-oxygen levels,
thereby providing an early warning that something was wrong with
the patient's breathing system. Prodded by Pierce and others, the
anesthésiology society made the use of both types of monitor for
every patient receiving general anesthesia an official standard.
Today, anesthesia deaths from misconnecting the breathing system
or intubating the esophagus rather than the trachea are virtually
unknown. In a decade, the over-all death rate dropped to just one in
more than two hundred thousand cases-less than a twentieth of
what it had been.
And the reformers have not stopped there. David Gaba, a
professor of anesthesiology at Stanford, has focussed on improving
human performance. In aviation, he points out, pilot experience is
recognized to be invaluable but insufficient: pilots seldom have direct
experience with serious plane malfunction anymore. They are
therefore required to undergo yearly training in crisis simulators.
Why not doctors, too? G
Gaba, a physician with training in engineering, led in the design
of an anesthesia-simulation system known as the Eagle Patient
Simulator. It is a lifesize, computer-driven mannequin that is capable
of amazingly realistic behavior. It has a circulation, a heartbeat, and
lungs that take in oxygen and expire carbon dioxide. If you inject
drugs into it or administer inhaled anesthetics, it will detect the type
and amount, and its heart rate, its blood pressure, and its oxygen
levels will respond appropriately. The "patient" can be made to
develop airway swelling, bleeding, and heart disturbances. The
mannequin is laid on an operating table in a simulation room
equipped exactly like the real thing. Here both residents and
experienced attending physicians learn to perform effectively in all
kinds of dangerous, and sometimes freak, scenarios: an anesthesia-
machine malfunction, a power outage, a patient who goes into cardiac
arrest during surgery, and even a cesarean-section patient whose
airway shuts down and who requires an emergency tracheostomy.
Though anesthesiology has unquestionably taken the lead in
analyzing and trying to remedy "systems" failures, there are signs of
change in other quarters. The American Medical Association, for
example, set up its National Patient Safety Foundation in 1997 and
asked Cooper and Pierce to serve on the board of directors. The
foundation is funding research, sponsoring conferences, and
attempting to develop new standards for hospital drug-ordering
systems that could substantially reduce medication mistakes-the
single most common type of medical error.
Even in surgery there have been some encouraging
developments. For instance, operating on the wrong knee or foot or
other body part of a patient has been a recurrent, if rare, mistake. A
typical response has been to fire the surgeon. Recently, however,
hospitals and surgeons have begun to recognize that the body's
bilateral symmetry makes these errors predictable. Last year, the
American Academy of Orthopedic Surgeons endorsed a simple way of
preventing them: make it standard practice for surgeons to initial,
with a marker, the body part to be cut before the patient comes to
surgery.
The Northern New England Cardiovascular Disease Study Group,
based at Dartmouth, is another success story. Though the group
doesn't conduct the sort of in-depth investigation of mishaps that
Jeffrey Cooper pioneered, it has shown what can be done simply
through statistical monitoring. Six hospitals belong to this consortium,
which tracks deaths and complications (such as wound infections,
uncontrolled bleeding, and stroke) arising from heart surgery and
tries to identify various risk factors. Its researchers found, for
example, that there were relatively high death rates among patients
who developed anemia after bypass surgery, and that anemia
developed most often in small patients. The fluid used to "prime" the
heart-lung machine caused the anemia, because it diluted a patient's
blood, so the smaller the patient (and his or her blood supply) the
greater the effect. Members of the consortium now have several
promising solutions to the problem. Another study found that a
group at one hospital had made mistakes in "handoffs"-say. in
passing preoperative lab results to the people in the operating room.
The study group solved the problem by developing a pilot's checklist
for all patients coming to the O.R. These efforts have introduced a
greater degree of standardization, and so reduced the death rate in
those six hospitals from four per cent to three per cent between
1991 and 1996. That meant two hundred and ninety-three fewer
deaths. But the Northern New England cardiac group, even with its
narrow focus and techniques, remains an exception; hard information
about how things go wrong is still There is a hodgepodge of
evidence that latent errors and systemic factors may contribute to
surgical errors: the lack of standardized protocols, the surgeon's
inexperience, the hospital's inexperience, inadequately designed
technology and techniques, thin staffing, poor teamwork, time of
day. the effects of managed care and corporate medicine, and so on
and so on. But which are the major risk factors? We still don't know.
Surgery, like most of medicine, awaits its Jeff Cooper.
V-GETTING IT RIGHT
IT was a routine gallbladder operation, on a routine day: on the
operating table was a mother in her forties, her body covered by
blue paper drapes except for her round, antiseptic-coated belly. The
gallbladder is a floppy, fingerlength sac of bile like a deflated olive-
green balloon tucked under the liver, and when gallstones form, as
this patient had learned, they can cause excruciating bouts of pain.
Once we removed her gallbladder, the pain would stop.
There are risks to this surgery, but they used to be much
greater. Just a decade ago, surgeons had to make a six-inch
abdominal incision that left patients in the hospital for the better
part of a week just recovering from the wound. Today, we've learned
to take out gallbladders with a minute camera and instruments that
we manipulate through tiny incisions. The operation, often done as
day surgery. is known as laparoscopic cholecystectomy, or "lap
chole." Half a million Americans a year now have their gallbladders
removed this way; at my hospital alone, we do several hundred lap
choles annually.
When the attending gave me the go-ahead, I cut a discreet
inch-long semicircle in the wink of skin just above the belly button. I
dissected through fat and fascia until I was inside the abdomen, and
dropped into place a "port," a half-inch-wide sheath for slipping
instruments in and out. We hooked gas tubing up to a side vent on
the port, and carbon dioxide poured in, inflating the abdomen until it
was distended like a tire. I inserted the miniature camera. On a video
monitor a few feet away, the woman's intestines blinked into view.
With the abdomen inflated, I had room to move the camera, and I
swung it around to look at the liver. The gallbladder could be seen
poking out from under the edge.
We put in three more ports through even tinier incisions,
spaced apart to complete the four corners of a square. Through the
ports on his side, the attending put in two long "graspers," like small-
scale versions of the device that a department-store clerk might use
to get a hat off the top shelf. Watching the screen as he maneuvered
them, he reached under the edge of the liver, clamped onto the
gallbladder, and pulled it up into view. We were set to proceed.
Removing the gallbladder is fairly straightforward. You sever it
from its stalk and from its blood supply, and pull the rubbery sac out
of the abdomen through the incision near the belly button. You let
the carbon dioxide out of the belly, pull out the ports, put a few
stitches in the tiny incisions, slap some Band-Aids on top, and you're
done. There's one looming danger, though: the stalk of the
gallbladder is a branch off the liver's only conduit for sending bile to
the intestines for the digestion of fats. And if you accidentally injure
this main bile duct, the bile backs up and starts to destroy the liver.
Between ten and twenty per cent of the patients to whom this
happens will die. Those who survive often have permanent liver
damage and can go on to require liver transplantation. According to a
standard textbook, "injuries to the main bile duct are nearly always
the result of misadventure during operation and are therefore a
serious reproach to the surgical profession." It is a true surgical error,
and, like any surgical team doing a lap chole, we were intent on
avoiding this mistake.
Using a dissecting instrument, I carefully stripped off the
fibrous white tissue and yellow fat overlying and concealing the base
of the gallbladder. Now we could see its broad neck and the short
stretch where it narrowed down to a duct-a tube no thicker than a
strand of spaghetti peeking out from the surrounding tissue, but
magnified on the screen to the size of major plumbing. Then, just to
be absolutely sure we were looking at the gallbladder duct and not
the main bile duct, I stripped away some more of the surrounding
tissue. The attending and I stopped at this point, as we always do,
and discussed the anatomy. The neck of the gallbladder led straight
into the tube we were eying. So it had to be the right duct. We had
exposed a good length of it without a sign of the main bile duct.
Everything looked perfect, we agreed. "Go for it," the attending said.
I slipped in the clip applier, an instrument that squeezes V -
shaped metal clips onto whatever you put in its jaws. I got the jaws
around the duct and was about to fire when my eye caught, on the
screen, a little globule of fat lying on top of the duct. That wasn't
necessarily anything unusual, but somehow it didn't look right. With
the tip of the clip applier, I tried to flick it aside, but, instead of a
little globule, a whole layer of thin unseen tissue came up, and,
underneath, we saw that the duct had a fork in it. My stomach
dropped. If not for that little extra fastidiousness, I would have
clipped off the main bile duct.
Here was the paradox of error in medicine. With meticulous
technique and assiduous effort to insure that they have correctly
identified the anatomy, surgeons need never cut the duct. It is a
paradigm of an avoidable error. At the same time, studies show that
even highly experienced surgeons inflict this terrible injury
about once in every two hundred lap choles. To put it another way, I
may have averted disaster this time, but a statistician would say
that, no matter how hard I tried, I was almost certain to make this
error at least once in the course of my career.
But the story doesn't have to end here, as the cognitive
psychologists and industrialerror experts have demonstrated. Given
the results they've achieved in anesthesiology, it's clear that we can
make dramatic improvements by going after the process, not the
people, But there are distinct limitations to the industrial cure,
however necessary its emphasis on systems and structures. It would
be deadly for us, the individual actors, to give up our belief in human
perfectibility. The statistics may say that someday I will sever
someone's main bile duct, but each time I go into a gallbladder
operation I believe that with enough will and effort I can beat the
odds. This isn't just professional vanity. It's a necessary part of good
medicine, even in superbly "optimized" systems. Operations like that
lap chole have taught me how easily error can occur, but they've also
showed me something else: effort does matter; diligence and
attention to the minutest details can save you.
This may explain why many doctors take exception to talk of
"systems problems," "continuous quality improvement," and "process
reengineering." It is the dry language of structures, not people. I'm
no exception: something in me, too, demands an acknowledgment of
my autonomy, which is also to say my ultimate culpability. Go back
to that Friday night in the E.R., to the moment when I stood, knife in
hand, over Louise Williams, her lips blue, her throat a swollen,
bloody, and suddenly closed passage. A systems engineer might have
proposed some useful changes. Perhaps a backup suction device
should always be at hand, and better light more easily available.
Perhaps the institution could have trained me better for such crises,
could have required me to have operated on a few more goats.
Perhaps emergency tracheostomies are so difficult under any
circumstances that an automated device could have been designed to
do a better job. But the could-haves are infinite, aren't they? Maybe
Williams could have worn her seat belt, or had one less beer that
night. We could call any or all of these factors latent errors, accidents
waiting to happen.
But although they put the odds against me, it wasn't as if I had
no chance of succeeding. Good doctoring is all about making the most
of the hand you're dealt, and I failed to do so. The indisputable fact
was that I hadn't called for help when I could have, and when I
plunged the knife into her neck and made my horizontal slash my
best was not good enough. It was just luck, hers and mine, that Dr.
O'Connor somehow got a breathing tube into her in time.
There are all sorts of reasons that it would be wrong to take
my license away or to take me to court. These reasons do not absolve
me. Whatever the limits of the M. &M., its fierce ethic of personal
responsibility for errors is a formidable virtue. No matter what
measures are taken, medicine will sometimes falter, and it isn't
reasonable to ask that it achieve perfection. What's reasonable is to
ask that medicine never cease to aim for it.
LTEBERIAN-DU
FAX
UNITED STATES SENATOR CONNECTICUT
Joseph I. Lieberman
Fax to: Chris Jennings
Date
Fax# 456-5557
Pages
From:
Message:
Hartford Office One State Street Suite 1420 Hartford, CT. 06103 (860) 549-8463 Fax (860)549-8478
United States Senate Washington, D.C. 20510-4601 (202) 224-4041 Fax: (202)224-9750
United States Senate
WASHINGTON, DC 20510
February 3, 2000
The Honorable Togo West
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, N.W.
Washington DC 20420
Dear Secretary:
Late last year, the Institute of Medicine found that that preventable medical errors in
hospitals are a leading cause of death in our Nation. The Institute found that over half of the
adverse medical events that occur each year are preventable, causing the deaths of as many as
98,000 Americans annually and adding as much as $29 billion to our nation's health care
spending.
The IOM stated that "health care is a decade or more behind other high-risk industries in
its attention to ensuring basic safety." For example, our health care system has not matched
commercial aviation's efforts to ensure basic safety that resulted in eliminating all airline deaths
on domestic flights in 1998.
We are concerned that many of the deaths and serious injuries occur in federal programs
including Medicare, Medicaid, the Federal Employees Benefits program, Veterans' Health, and
the Department of Defense's health care program - Tricare.
In all, these programs account for almost half of the health care expenditures in the
United States and cover approximately 90 million beneficiaries. Total deaths in these programs
may number in the tens of thousands each year.
As a first step to reform, we are examining the recommendations identified by the
Institute of Medicine as "a roadmap to ward a safer health system."
On January 23, the New York Times reported that federal officials have already rejected
one of the recommendations in the IOM report -- requiring hospitals to report all deaths and
serious injuries. The basis for rejecting this recommendation in isolation from the other
recommendations and the status of deliberations on the other recommendations was not
described.
Would you please tell us:
United States Senate
WASHINGTON, DC 20510
February 3, 2000
The Honorable William S. Cohen
Secretary of Defense
The Pentagon
Washington DC 20301
Dear Mr. Secretary:
Late last year, the Institute of Medicine found that preventable medical errors in hospitals are a
leading cause of death in our Nation. The Institute found that over half of the adverse medical
events that occur each year are preventable, causing the deaths of as many as 98,000 Americans
annually and adding as much as $29 billion to our nation's health care spending.
The IOM stated that "health care is a decade or more behind other high-risk industries in its
attention to ensuring basic safety." We are concerned that many of the deaths and serious
injuries occur in federal programs including Medicare, Medicaid, the Federal Employees
Benefits program, Veterans' Health, and the Department of Defense's health care program -
Tricare.
In total, these programs account for almost half of the health care expenditures in the United
States and cover approximately 90 million beneficiaries. Total deaths in these programs may
number in the tens of thousands each year.
As a first step to reform, we are examining the recommendations identified by the Institute of
Medicine as "a roadmap toward a safer health system."
On January 23, the New York Times reported that some federal officials have already rejected
one of the recommendations in the IOM report -- requiring hospitals to report all deaths and
serious injuries. The basis for rejecting this recommendation in isolation from the other
recommendations and the status of deliberations on the other recommendations was not
described. However, we read that the Department of Defense will soon be requiring military
hospitals to report medical errors and that such reports will be kept confidential.
In light of these reports, would you please tell us:
1) How many preventable deaths occur each year in the Department of Defense, including how
many deaths you expect to occur this year.
2) Your plan for achieving the Institute of Medicine's goal of reducing preventable medical error
Cohen/Page 2
by fifty percent over the next five years.
3) Your basis for deciding to keep reported medical errors confidential.
Congress and the Administration must take seriously the IOM's goal of reducing medical errors
by at least 50 percent over five years. We look forward to hearing from you as quickly as
possible.
Sincerely,
J bilm
Chuck Gapsley Henry
Gubric
United States Senate
WASHINGTON, DC 20510
February 3, 2000
The Honorable Donna E. Shalala
Secretary of Health and Human Services
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington DC 20201
Dear Madam Secretary:
Late last year, the Institute of Medicine found that that preventable medical errors in
hospitals are a leading cause of death in our Nation. The Institute found that over half of the
adverse medical events that occur each year are preventable, causing the deaths of as many as
98,000 Americans annually and adding as much as $29 billion to our nation's health care
spending.
The IOM stated that "health care is a decade or more behind other high-risk industries in
its attention to ensuring basic safety." For example, our health care system has not matched
commercial aviation's efforts to ensure basic safety that resulted in eliminating all airline deaths
on domestic flights in 1998.
We are concerned that many of the deaths and serious injuries occur in federal programs
including Medicare, Medicaid, the Federal Employees Benefits program, Veterans' Health, and
the Department of Defense's health care program - Tricare.
In all, these programs account for almost half of the health care expenditures in the
United States and cover approximately 90 million beneficiaries. Total deaths in these programs
may number in the tens of thousands each year.
As a first step to reform, we are examining the recommendations identified by the
Institute of Medicine as "a roadmap to ward a safer health system."
On January 23, the New York Times reported that federal officials have already rejected
one of the recommendations in the IOM report -- requiring hospitals to report all deaths and
serious injuries. The basis for rejecting this recommendation in isolation from the other
recommendations and the status of deliberations on the other recommendations was not
described.
Shalala/Page 2
Would you please tell us:
1) How many preventable deaths occur each year in the federal health programs under
your supervision, including how many deaths you expect to occur this year.
2) Your basis for accepting or rejecting the Institute of Medicine's recommendations
including mandatory reporting of deaths.
3) Your plan for achieving the Institute of Medicine's goal of reducing preventable
medical error by fifty percent over the next five years.
Congress and the Administration must take seriously the IOM's goal of reducing medical errors
by at least 50 percent over five years. We look forward to hearing from you as quickly as
possible.
Sincerely,
& Julin bilm
BiKey
Chuck Non Nill Grassley
** TOTAL PAGE . 06 **
FEB-02-2000 13:30
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P.01/02
Department of Veterans Affairs
Veterans Health Administration
Office of the Under Secretary for Health
810 Vermont Avenue, N.W.
Washington, DC 20420
Fax: 202.273.7090
atuc
Date:
2/2/2000
# of Pages to Follow:
I
CHRIS JENNINGS
To:
DEVORAH ADLER
Phone: 202.456.5557 (fax)
From:
TOM GARTHWARK, VA.
Comments: I'M STILL LEARNING ABOUT PATIENT SAPETY
AS
A RESULT OF ANOTHER HEARING AND A SESSION AT# THE JFK
SCHOOL OF GOU'T ON MEDICAL ERROR LAST WEEK, I PROVIDE
THE ATTACMED AS AN EVOLUTION OF MY THINKING. COPY TO
JOHN EISENBERG @ AHRQ 1QUIC.
Please call 202.273. 5781
if you have any questions.
This transmission is intended only for the use of the person or office to whom it is addressed and may contain
information that is privileged, confidential, or protected by law.
All others are hereby notified that receipt of this message does not waive any applicable privilege or exemption
from disclosure and that any dissemination, distribution, or copying of this communication is prohibited.
If you have received this communication in error, please notify us immediately at the telephone number shown
above. Thank you.
FEB-02-2000 13:31
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Thoughts on Patient Safety
February 2, 2000
The public has a need for:
a safer system
disclosure and compensation for injury
ability to chose a safe system for care
The development of a safer system requires:
ability of organizations to disclose error without threat of adverse publicity
ability of individuals in organizations to disclose errors without threat of punishment
analysis and discussion of mistakes (broad disclosure increases the likelihood of creative
and effective solutions)
implementation of new standards
Six part proposal:
1. Full disclosure of error to patient or family [full disclosure is simply the right thing to do;
provides an incentive for just compensation and honest admission as the risk of publicity
is dependent on the patient]
2. Mandatory reporting of error to a state and national safety database - either protected by
statute from disclosure or reported in de-identified manner [cannot do rates of error as
identification is ultimately voluntary and denominator is not measurable - thus, the most
honest are likely to appear most error prone; cannot fix problems if they are not identified
and shared; would need clear standards for what is to be reported]
3. Separate voluntary reporting system similar to Aviation Safety Reporting System
[mandatory and voluntary systems are complementary and in aviation have yielded
significantly different information]
4. Rigorous process of analysis of the safety database and formal adoption of new safery
standards [requires an open process to identify new standards which every system must
implement; might be best to start with a new standard setting body with representation
from healthcare organizations and patients; recent examples of such standards might
include the universal use of pulse oximetry in anesthesia, the removal of concentrated
KCI from medical wards, etc.]
5. Required implementation of safety standards [at a minimum, public disclosure of safety
standards so patients could ask and select providers based on adherence to those
standards; stronger statement might be making adherence to new safety standards a
condition of participation in Medicare]
6. Recurring audits [either by existing organizations such as Peer Review Organizations or
Joint Commission on Accreditation of Health Care Organizations; or new organizations]
with public disclosure of:
adherence to policy to disclose errors to the patient or family
adherence to mandatory database reporting
implementation of safety standards
implementation of an effective safety program
Thomas L. Garthwaite, MD
TOTAL P.02
NO.490 P001/002
02/01/00 13:17
TELEFAX TRANSMITTAL SHEET
FOOD AND DRUG ADMINISTRATION
Office of Policy, Planning and Legislation
OL',
5600 Fishers Lane
Parklawn Bldg. / Room 14-101
Rockville, MD 20850
TEL: (301) 827-3360
FAX:
PLEASE DELIVER THE FOLLOWING PAGES
TO:
Ms. Devorra Adler
DATE: 2/1/00
TELEPHONE #:
FAX
202-456-5557
#:
FROM: Bill Hubbard
COMMENTS: The attached graphics maybe helpful as a concept if you guys
say anything about Medical Errors.
NUMBER OF PAGES, INCLUDING
COVER:
IF YOU DO NOT RECEIVE THE NUMBER OF PAGES INDICATED ABOVE,
PLEASE CALL IMMEDIATELY
This document is intended only for the use of the party to whom it is addressed and may contain information that is
privileged, confidential, and protected from disclosure under applicable law. If you are not the addressee, or a person
authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination,
copying, or other action based on the content, of this communication is not authorized. If you have received this document in
error, please immediately notify us by telephone and return it to us at the above address by mail. Thank you.
02/01/00
13:17
NO. 490
P002/002
health
'Premium' plasma
before
Isn't 'regular' blood safe enough?
Y
ou've probably heard the horror
stroy any viruses that cause AIDS (by far
ally more important. The new test can de-
stories about people who go into
the deadliest risk from blood) or hepatitis
tect the virus itself, not just the telltale
the hospital for minor surgery
C (by far the most common transfusion
signs of the virus, which can take weeks or
and leave with AIDS or hepatitis from a
risk). The price of the Red Cross'
months to appear. So NAT should radi-
contaminated blood transfusion. One
premium plasma: roughly 2½
cally shrink the old testing
recent response to the frightening
times the price of regular.
A new test
loophole-the chance of
prospect of blood-borne illness: brand-
Meanwhile America's Blood
name blood.
should slash the
missing a delayed sign of the
Centers, a group of nonprofit
virus-that created the need
The American Red Cross and V.I.
blood banks that supply the
chance of viral
to retest the donors or de-
Technologies, a biotech firm better
rest of the nation's blood, has
stroy the viruses in the first
known as Vitex, recently placed full-page
developed a competing prod-
contamination.
place. By the time this issue
ads in major Sunday newspapers urging
uct: donor-retested plasma.
of CONSUMER REPORTS is
people to "ask your physician for it by
This plasma is quarantined for several
published, virtually all blood in the U.S.
name!" "It" is PLAS+SD, the first blood-
months until the donor is retested for any
will be screened with the new test.
plasma product bearing a brand name
delayed signs of the worrisome viruses—
Moreover, washing and retesting are
and backed by an ambitious marketing
indicators that might have eluded the first
technically feasible only for plasma. But
campaign. The Red Cross, which sup-
test. Donor-retested plasma costs about
plasma accounts for only about one of
plies roughly half the nation's blood, has
60 percent more than regular. The
every seven units (pints) of blood trans-
an exclusive agreement to supply Vitex
chance of getting the AIDS or hepatitis C
fused in the U.S. (Most of the other units
with plasma-the liquid part of the
virus from either premium plasma: virtu-
contain either red cells, which transport
blood, rich in antibodies and clotting
ally zero.
oxygen, or platelets, which help stop
compounds-then to distribute the fin-
But despite all the hubbub about the
bleeding.) In contrast, NAT can spot
ished product nationwide. The new
new plasmas, a third, quieter innovation
viruses in any component of the blood
plasma gets washed in chemicals that de-
called nucleic-acid testing (NAT) is actu-
and can thus help protect everyone who
gets a transfusion.
The new blood and the new test raise
What's the risk?
two crucial questions: How safe is the
U.S. blood supply? And is either of the
This chart compares the average chances
The transfusion risks shown here should
of a hospital patient's being infected from
become even slimmer as nucleic-acid
premium plasmas worth the price?
a transfusion against the annual risk of
testing is phased in (see story).
Dramatic improvement
other life-and-death events. Transfusion
As the chart shows, the likelihood of
data are for twounits of blood, the
infection from a two-unit blood transfusion
In the 1970s high rates of hepatitis
amount often given during routine
is substantially less than the chance of
from transfusions triggered a sweeping
surgery such as knee replacement.
being murdered or of being killed in an
re-examination of blood banks' proce-
(However, some complicated cases-
auto accident during the year, Indeed,
dures. Most important, the banks stopped
such as heart surgery, care for car-crash
for a hospital patient, the greatest risk
collecting blood from paid donors, who
victims, or organ transplantation-
shown here is dying from an unexpected
may require far more units than that.)
adverse reaction to some medication.
were more likely than unpaid donors to
be sick.
000
000
1 in 100,000
1in10,000
The advent of AIDS in the early 1980s
1 in 1,000
forced further reforms. The riskiest
donors-intravenous-drug abusers and
Risk
Risk
gay men-were asked not to donate or
decreasing
increasing
were screened out by questionnaires, in-
terviews, or physical exams. And new tests
Fatal
were developed to detect the AIDS virus
plane
crash
Death
in donor blood. The payoffs were huge.
Death
by
In 1984, the year before blood banks
from
murder
Fatal,
got an AIDS-virus test, 714 transfusion
lightning
Fatal
unexpected
recipients were infected with the disease,
auto
drug
Infection with
Infection with
reaction in
according to a 1997 government report.
accident
AIDS virus from
hepatitis c virus
hospital
Over the next 12 years, a total of just
38 cases of AIDS were linked to transfu-
transfusion
from transfusion
sions of blood that had tested negative
Sources: Goodnough, L of al., New England Journal of
JAMA, vol. 279, no. 15 (adverse drug reactions); Laudan, 4,
for the virus-and the vast majority of
Illastrations by Jack Tom
Medicine, vol. 30, no 6 (transfusion risks): Lazarou, J. et al.,
The Book of Risks," John Wiley, 1994.
chose Cajci occurred in the early years,
CONSUMER REPORTS SEPTEMBER 1999
61
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National Patient Safety Partnership
For more information, contact:
VA Public Affairs, 202-273-5700
May 12, 1999
FOR IMMEDIATE RELEASE
HEALTHCARE LEADERS URGE ADOPTION OF METHODS TO REDUCE
ADVERSE DRUG EVENTS
Washington, D.C. - A coalition of healthcare organizations today released
recommendations for reducing the occurrence of adverse drug events.
Stressing that this is a problem that neither government nor individual
healthcare organizations can solve working alone, Kenneth W. Kizer, M.D., M.P.H.,
U.S. Department of Veterans Affairs' (VA) Under Secretary for Health, said the
public-private National Patient Safety Partnership is urging consumers, healthcare
practitioners, healthcare provider organizations and healthcare purchasing
cooperatives to adopt successful methods of preventing adverse drug events.
"Treatment-related adverse drug events are a major problem in this country
that exact high costs in patient morbidity and mortality as well as dollars," said Dr.
Kizer. "The Partnership can make significant patient safety improvements through
advocacy of best practices to reduce errors associated with prescribing, purchasing,
dispensing and administering of medications."
The patient safety group encouraged healthcare practitioners and healthcare
provider organizations to commit to certain best, or model, practices and work
together to implement them, in partnership with consumers, patient advocacy
groups, and the pharmaceutical industry. Their recommendations follow.
- more -
'The NPSP is a voluntary public-private partnership dedicated to reducing preventable adverse medical events. Its
members include American Hospital Association*, American Medical Association", American Nurses Association*,
Association of American Medical Colleges*, Agency for Health Care Policy and Research, Food and Drug
Administration, Health Care Financing Administration, Joint Commission on Accreditation of Healthcare
Organizations*, Institute for Healthcare Improvement*, National Institute for Occupational Safety and Health,
National Patient Safety Foundation at the AMA". Department of Defense - Health Affairs, and Department of
Veterans Affairs*.
*Charter Organizations
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Adverse Drug Events -- Page 2
To reduce the occurrence of adverse drug events (events that can cause, or
lead to, inappropriate medication use and patient harm),
Patients can:
Tell physicians about all medications they are taking
and responses/reactions to them
Ask for information in terms they understand
before accepting medications
Providing Organizations and Practitioners can:
Educate patients
Put allergies and medications on patient records
Stress dose adjustment in children and older persons
Limit access to high hazard drugs
Use protocols for high hazard drugs
Computerize drug order entry
Use pharmacy-based IV and drug mixing programs
Avoid abbreviations
Standardize drug packaging, labeling, storage
Use "unit dose" drug systems (packaged and labeled in standard patient doses)
Purchasers can:
Require machine-readable labeling (barcoding)
Buy drugs with prominent display of name, strength, warnings
Buy "unit of use" packaging (aka "unit dose")
Buy IV solutions with two sided labeling
-more-
DEC-06-1999 12:45
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Adverse Drug Events -- Page 3
To reduce the potential for taking a medication that was not prescribed for them or
cannot be safely taken by them, patients should ask the following five sets of
questions before accepting prescription drugs.
Is this the drug my doctor (or other health care provider) ordered? What is the
trade and generic name of the medication?
What is the drug for? What is it supposed to do?
How and when am I supposed to take it and for how long?
What are the likely side effects? What do I do if they occur?
Is this medication safe to take with other over-the-counter or prescription
medications, or dietary supplements, that I am already taking? What food,
drink, activities, dietary supplements or other medication should be avoided
while taking this medication?
###
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National Patient Safety Partnership
1
Statement Regarding
Its Initiative to
Reduce Preventable Adverse Drug Events
May 12, 1999
Various studies have shown that adverse drug experiences or events affect between 2 and 35
percent of hospitalized patients. Preventable adverse drug events represent a significant subset
of these, if not a large majority of them. Little is known about the incidence of adverse drug
events in outpatients, although they have been shown to be a significant cause of
hospitalization and, consequently, increased health care costs. Indeed, adverse drug events
are a cause of increased healthcare costs in all care settings.
For this initiative, a preventable adverse drug event (PDE)' is defined as an event that can be
anticipated and forestalled and that will cause or lead to inappropriate medication use or patient
harm while the medication is in the control of the healthcare professional, patient, or consumer.
Such events may be related to professional practice, healthcare products, procedures, and
systems, including prescribing; order communication; product labeling, packaging, and
nomenclature; compounding or dispensing; distribution; administration; education; monitoring;
and use.² Overall, PDEs are a serious public health and medical care problem because of the
large number of drugs, doses, and drug treatment regimens currently available and the many
changes in the manner that healthcare is provided today.
The National Patient Safety Partnership is a public-private partnership dedicated to improving
healthcare in general and patient safety in particular by reducing adverse events and untoward
outcomes of healthcare or healthcare-related processes. The members of the Partnership
believe there are significant patient safety improvements that can be made through the
prevention of avoidable adverse events associated with the prescribing, dispensing and
administering of medications.
The members of the National Patient Safety Partnership believe that prevention of medication-
related adverse events will be maximized when the outcomes of specific actions for
improvement can be reliably predicted based on a strong body of evidence. It realizes that the
current evidence base needs strengthening and believes that iterative improvement
accompanied by outcomes analysis can advance the state of the science toward that goal.
Based on current knowledge, the Partnership has identified a number of "best practices" or
"model practices" that could substantially reduce the potential for occurrence of PDEs, and the
Partnership calls on healthcare consumers, patient advocacy groups, the pharmaceutical
industry, healthcare practitioners and healthcare organizations to make a commitment to adopt
the practices listed below and to work together to implement them, as well as to develop
additional ways to reduce PDEs.
1 The differences between a PDE and the Food and Drug Administration's (FDA) broader statutory definition of an adverse drug
experience or event should be recognized. The National Patient Safety Partnership's principal interest is advancing practices that
prevent adverse events whereas the FDA's principal Interest is understanding drug/drug Interactions and the biologic activity of
drugs so they are fully labeled. At 21 CFR section 314.80 FDA defines an adverse drug experience as any adverse event
associated with the use of a drug in humans. whether or not considered drug related, including the following: an adverse event
occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose,
whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal;
and any failure of expected pharmacological action.
2 Adapted from the USP Quality Review - Definition of Medication Errors
1
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Model Practices to Prevent Adverse Drug Events³
Current Best Practices For Patients/Consumers
The members of the National Patient Safety Partnership believe that all patients should be
actively involved in their care and decisions concerning their care. There are many actions that
patients can take, but the following two are stressed as ways to ensure that medication-related
information is exchanged in a way that increases the probability of safe care.
1. Patients (or their personal advocates) should always inform their physician or other
healthcare practitioner of all medications they are taking (NB: This includes prescription
medication, over-the-counter medication and dietary supplements.) as well as about any
and all allergies or previous adverse drug experiences they have experienced before
accepting any new medication. Patients should not assume that information previously
provided has been communicated or has been considered prior to a medication being
prescribed or administered.
2. Patients (or their personal advocates) should request information about medications in
terms that they can understand, both at the time the medication(s) is/are being prescribed
and when they are received. This applies to prescription and over-the-counter medications.
Patients should ask for information about the intended use or purpose of the drug, possible
drug-drug interactions, potential hazards associated with taking several medicines (e.g.,
more than 3 drugs at the same time), and about changes in the appearance of any
medications they have been taking (such as when a prescription refill is a different color
from what had previously been taken). Before accepting or receiving a prescription, the
patient should always ask the following questions:
Is this the drug my doctor (or other health care provider) ordered? What is the trade and
generic name of the medication?
What is the drug for? What is it supposed to do?
How and when am I supposed to take it and for how long?
What are the likely side effects? What do I do if they occur?
Is this new medication safe to take with other over-the-counter or prescription
medications, or dietary supplements, that I am already taking? What food, drink,
activities, dietary supplements or other medication should be avoided while taking this
medication?
In addition, at the time prescription medications are received from pharmacies, patients should
ask if the drug they are receiving is the one their doctor or other health care provider ordered
and ask that both the trade and generic names be listed on the prescription label.
3 The ordering of these "Best Practices" is not intended to suggest relative importance. The "Best Practices" are Identified on the
basis of eight techniques or criteria that have been shown to be important in reducing errors in general and medication errors in
particular. The eight criteria are 1) ensuring timely access to Information; 2) standardization; 3) simplification; 4) reduced reliance on
memory; 5) reduced reliance on practitioner vigilance; 6) broad application; 7) cost effectiveness of the intervention; and 8)
established success of the intervention. The 16 practices are used in the Institute for Healthcare Improvement Breakthrough Series.
2
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Current Best Practices For Providing Organizations and Practitioners
The members of the National Patient Safety Partnership believe that healthcare organizations
and practitioners are committed to safeguarding patients and call upon both organizations and
individual practitioners to further advance the following practices and to support and advocate
for these actions in areas and organizations in which they are not utilized.
3. Educate patients, family members and other caregivers about all medications (both
prescription and over-the-counter, including dietary supplements) that are used. (Emphasis
should be placed on the hazards of polypharmacy, drug-drug interactions and possible
adverse effects.) Patients and caregivers should be encouraged to ask for information
about all medications and dietary supplements, especially when new medications are
prescribed or changes in medications are made.
4. Prominently display critical patient information, such as drug allergies and medication
regimens, on every patient record.
5. Emphasize the need for dose adjustment in children and elderly patients. In some elderly
patients, a reduction in dose may be required because of age-related changes in body mass
and organ function.
6. Limit accessibility to and control the use of highly toxic or other high-hazard drugs such as
potassium chloride or concentrated epinephrine.
7. Insist on the development and use of protocols for highly toxic or hazardous drugs or those
with a narrow therapeutic range. (Computerized drug order entry systems can be especially
important in facilitating this with alerts, restrictions or suggestions for safer substitutes.)
8. Computerize drug order entry whenever possible. If computerized drug order entry is not
feasible, then use pre-printed order forms for drugs in inpatient settings and, where
appropriate, in ambulatory care settings.
9. Utilize pharmacy-based intravenous (IV) admixture programs.
10. Avoid the use of abbreviations whenever possible; if abbreviations are used, they should be
standardized throughout the organization and their use minimized.
11. Standardize approaches and processes for drug storage locations, internal packaging or
labeling and delivery, and require use of the standardized approaches and processes.
12. Use unit dose drug distribution systems for inpatient care; also use such systems for
outpatient care, where appropriate.
3
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Current Best Practices For Purchasers
The members of the National Patient Safety Partnership believe that while most of these
practices advocated in this initiative would cost little or nothing to implement, they do recognize
that an investment will be required for some and call upon healthcare organizations and the
pharmaceutical industry to make any needed investment in the interest of patient safety.
13. Require machine-readable labeling, such as a barcoding system, complete with pertinent
information such as lot number and expiration date.
14. Preferentially purchase products that have labels with name of drug, concentration and
warnings prominently displayed and that otherwise incorporate human factors evaluation
into naming, labeling and packaging processes. (For example, the use of large type or
contrasting colors to avoid look-alike packaging or unheeded warnings.)
15. Preferentially purchase and utilize "unit of use" packaging in inpatient settings; also use
such packaging in outpatient (ambulatory care) settings, where appropriate.
16. Preferentially purchase intravenous (IV) solutions with contents and concentration
prominently displayed on both sides of the container.
Even Better Practices in the Future
Finally, the members of the National Patient Safety Partnership believe it is imperative that the
healthcare and pharmaceutical industries launch and sustain collaborations directed toward
systematic approaches to the prevention of PDEs. The Partnership challenges these industries
to seek opportunities for research and to seek collaborations to identify better practices in the
future, to prioritize practice interventions, and to define practices that can predictably effect
improvement in terms of increased safety and cost-effectiveness. Integral to such an activity is
a non-punitive culture that encourages reporting of adverse or unexpected events to relevant
oversight bodies, including internal quality management systems and regulatory agencies, and
that provides feedback about resulting lessons learned and system changes aimed at
preventing future such events. To be truly successful these activities must be ongoing since no
solution that is found to any problem can be thought of as the "solution for all time", A spirit of
continual and relentless examination and reexamination will be necessary to insure that our
processes and techniques are appropriate today and that they continue to evolve as necessary
to be appropriate in the future as well.
4
TOTAL P.08
DRAFT: PRESIDENT CLINTON TAKES STRONG NEW STEPS TO IMPROVE
HEALTH CARE QUALITY AND ENSURE PATIENT SAFETY
December 7, 1999
Today, President Clinton will sign an executive memorandum directing the Federal Quality
Interagency Coordination (QuIC) Task Force report back to him in 60 days with an action plan to
improve health care quality and ensure patient safety through the prevention of medical errors.
The President also directed the Office of Management and Budget, the Domestic Policy Council,
and the Department of Health and Human Services to develop health care quality and patient
safety initiatives for the FY 2001 budget; directed the Health Care Financing Administration to
integrate patient safety initiatives into the Medicare program; and announced a new, multi-
million dollar investment in research programs to improve health care quality. In addition, the
President praised the American Hospital Association for the strong new steps it is taking,
including issuing guidance on preventing medical errors to all 5,000 member hospitals, to
improve quality of care and protect patient safety. The new actions being taken by the President
today build upon the Clinton-Gore Administration's longstanding commitment to improving
health care quality.
INCONSISTENCIES AND AVOIDABLE ERRORS IN MEDICAL PRACTICE COST
LIVES AND UNDERMINE HEALTH. Ensuring that patients are free from accidental injury
and preventing inappropriate or unsuccessful courses of treatment is are critically important to
both patients and providers. However, inappropriate utilization of services, unnecessary
variations in the delivery of health care services, and preventable medical errors at all stages are
responsible for tens of thousands of deaths, unnecessary illnesses, and instances of prolonged
disability annually.
Preventable medical errors. Over half of the adverse medical events occurring each year
are due to preventable medical errors, placing at least 40,000 and as many as 98,000
Americans at unnecessary risk. More people die each year as a result of medical errors than
from motor vehicle accidents, breast cancer, or AIDS. A recent study by the Institute of
Medicine estimates that the cost associated with these unnecessary errors in lost income,
disability, and health care costs is as much as $29 billion annually. The financial impact of
these errors is compounded by the cost of patients' loss of trust in the health care system and
the physical and psychological discomfort associated with longer hospital stays or permanent
disability.
Under-utilization of services. Early detection and treatment for illnesses prevents
unnecessary complications, higher costs, and premature mortality. For instance, despite the
fact that early detection of breast cancer can prevent up to 30 percent of breast cancer deaths
annually, 30 percent of women aged 52 to 69 do not receive regular mammograms.
Overuse of services. The excessive and unnecessary delivery of health care services can
increase costs without improving health and place patients at greater risk for injuries and
complications. For example, an analysis of hysterectomies provided by seven managed care
plans indicated that 16 percent were unnecessary. In another example, the overuse of
antibiotics imposes unnecessary health care costs and contributes to the emergence of
antibiotic-resistant pathogens, causing as much as $7.5 billion in unnecessary costs annually.
Variation in services. There is a continuing pattern of wide variation in health care practice
that cannot be accounted for by differences in the health status of patients, available
resources, patient preferences, or clinical uncertainty. For example, the percent of C-section
births in Washington state hospitals ranged from 0 to 43 percent. In another example,
hospital discharge rates and lengths of stay in the Northeast were over 40 percent higher than
in Western states. Such variation is a clear indicator that clinical practice does not ensure
evidence-based practice in the United States.
NEW ACTION TO IMPROVE HEALTH CARE QUALITY AND ENSURE PATIENT
SAFETY. Today, President Clinton will:
Issue an Executive Memorandum directing the Quality Interagency Coordination Task
Force to develop new strategies to improve health care quality and protect patient
safety. Today, President Clinton will sign an executive memorandum directing the Quality
Interagency Coordination Task Force (QuIC) to report back to him in 60 days with an action
plan that: identifies medical errors that can be prevented through the use of decision support
systems; includes proposals to eliminate barriers preventing adoption of information
technology systems in different health care settings; proposes a strategy for the reduction of
medical errors in Federal health care programs; detail specific actions that the Federal
government can take with the private sector to reduce medical errors; provides a plan for
continued, coordinated, collaboration on health care quality issues with the QuIC and the
Quality Forum; provides technical support to the Health Care Financing Administration in
the development of pilot projects implementing patient safety initiatives; and evaluate the
feasibility and advisability of implementing or supporting the recommendations of the
Institute of Medicine on patient safety.
Praise the American Hospital Association for launching a new medication safety
campaign. The President will praise the American Hospital Association for launching a new
initiative to prevent patient medication errors that includes: sharing a list of "best practices"
with every hospital and health system; developing a medication safety awareness test that
surveys hospitals' medication error prevention systems; tracking implementation by the
hospital and health system field of the practices for reducing and preventing errors; and
working with national experts to develop a model medication error reporting process.
Announce a new, multi-million dollar investment in research programs to improve
health care quality. President Clinton will announce that he will sign legislation in the
coming days that will ensure that the Agency for Healthcare Quality and Research (AHQR),
will invest over $ million in FY 2000 in new research to prevent medical errors and promote
patient safety. The President also announced that AHQR will increase its current investment
in research focusing on the over and under utilization of services and geographic variation in
the delivery of services by percent over the next year.
Direct the Health Care Financing Administration to initiate the development of patient
safety demonstration projects into the Medicare program. Today, President Clinton will
direct the Health Care Financing Administration (HCFA) to develop pilot projects that
promote patient safety and improve health care quality. These new programs will be
designed to reduce medical errors, prevent over and under-utilization of services, and assure
the use of the most recent treatment protocols in the Medicaid, Medicare, and CHIP
programs.
Direct the Office of Management and Budget to invest in health care quality and patient
safety initiatives when developing the FY 2001 budget. Today, the President will direct
the Office of Management and Budget to work with the Domestic Policy Council and the
Department of Health and Human Services to develop initiatives within the context of the FY
2001 budget that build on our current error prevention, quality improvement, and patient
safety initiatives.
THE CLINTON-GORE ADMINISTRATION'S LONGSTANDING COMMITMENT TO
IMPROVING HEALTH CARE QUALITY. Assuring quality through providing patient
protections is a longstanding priority for the Clinton-Gore Administration. Over the past two
years resident Clinton and Vice President Gore have provided critical consumer protections to
the 85 million Americans enrolled in Federal health plans and set the stage for the Congress to
pass a strong, enforceable, Patients' Bill of Rights. In March of 1998, the President established
the Quality Interagency Coordination Task Force, which has been instrumental in developing
disease management protocols that have been adopted nationwide. The Vice President launched
a public-private body known as the Quality Forum to coordinate Federal quality improvement
efforts with the private sector to provide consumers with a consistent set of standards in order to
base their health care choices on quality - not cost. In addition, the Departments of Defense and
Veterans Affairs have been leaders in employing information technology to enhance their ability
to provide higher quality of care to patients, including the use of electronic medical records for
many of their patients.
003
not sent to Hats yet. AMA voining ?
DRAFT: PRESIDENT CLINTON TAKES STRONG NEW STEPS TO IMPROVE
HEALTH CARE QUALITY AND ENSURE PATIENT SAFETY
December 7, 1999
DPC. + HIS develop to this
Today, President Clinton will sign an executive memorandum directing the Federal Quality
Interagency Coordination Task Force report back to him in 60 days with an action plan to
improve health care quality and ensure patient safety through the prevention of medical errors.
B.
The President also directed the Office of Management and Budget to invest m health care quality
and patient safety initiatives whenzleveloping the FY 2001 budget; directed the Health Care
Financing Administration to Integrate patient safety initiatives into the Medicare, Medicaid, and
pravad AHA
CHIP programs; and announced a new, multi-million dollar investment in research programs to
improve health care quality. The new actions being taken by the President today build upon the
Clinton-Gore Administration's longstanding commitment to improving health care quality.
INCONSISTENCIES AND AVOIDABLE ERRORS IN MEDICAL PRACTICE COST
LIVES AND UNDERMINE HEALTH. Inappropriate utilization of services, unnecessary
variations in the delivery of health care services, and preventable medical errors are responsible
for thousands of deaths, unnecessary illnesses, and instances of prolonged disability annually.
Leno
Dot
"Includes
Preventable medical errors. Over half of the adverse medical events occurring each year
are due to preventable medical errors. placing tens of thousands of Americans at unnecessary
risk. More people die each year as a result of medical errors than from motor vehicle
accidents, breast cancer, or AIDS. A recent study by the Institute of Medicine estimates that
the cost associated with these unnecessary errors in lost income, disability, and health care
costs is as much as $29 billion annually. The financial impact of these errors is compounded
by the cost of patients' loss of trust in the health care system, the physical and psychological
discomfort associated with longer hospital stays or permanent disabilityAreduced school
attendance, and lower levels of population health status.
Under-utilization of services. Early detection and treatment for illnesses prevents
unnecessary complications, higher costs, and premature mortality. For instance, despite the
fact that early detection of breast cancer can prevent up to 30 percent of breast cancer deaths
annually, 30 percent of women aged 52 to 69 do not receive regular mammograms.
Overuse of services. The excessive and unnecessary delivery of health care services can
increase costs without improving health and place patients at greater risk for injuries and
complications. For example, an analysis of hysterectomies provided by seven managed care
plans indicated that 16 percent were unnecessary. In another example. the overuse of
antibiotics imposes unnecessary health care costs and contributes to the emergence of
antibiotic-resistant pathogens, causing as much as $7.5 billion in unnecessary costs annually.
Variation in services. There is a continuing pattern of wide variation in health care practice
that cannot be accounted for by differences in the health Status of patients, available
resources, patient preferences, or clinical uncertainty. For example, the percent of C-section
births in Washington state hospitals ranged from 0 to 43 percent. In another example,
hospital discharge rates and lengths of stay in the Northeast were over 40 percent higher than
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in Western states. Such variation is a clear indicator that clinical practice does not ensure
evidence-based practice in the United States.
NEW ACTION TO IMPROVE HEALTH CARE QUALITY AND ENSURE PATIENT
SAFETY. Today, President Clinton:
will
Issued an Executive Memorandum directing the Quality Interagency Coordination
Task Force to develop new strategies to improve health care quality and protect patient
safety. Today, President Clinton signed an executive mernorandum directing the Quality
Interagency Coordination Task Force (QuIC) to report back to him in 60 days with an action
fines
plan that: identifies medical errors that can be prevented through the use of decision support
systems; includes proposals to eliminate barriers preventing adoption of information
technology systems in different health care settings; proposes a strategy for the reduction of
medical errors in Federal health care programs; detail specific actions that the Federal
government can take with the private sector to reduce medical errors; provides a plan for
continued, coordinated, collaboration on health care quality issues with the QuIC and the
Quality Forum; provides technical support to the Health Care Financing Administration in
Feest
the development of pilot projects implementing patient safety initiatives; and evaluates the
feash
recommendations of the Institute of Medicine on patient safety.
advision
of
Announced a new, multi-million dollar investment in research programs to improve
implanty
health care quality. President Clinton announced that the Agency for Healthcare Quality
or
and Research (AHQR), AHQR will invest over $2 million in FY 2000 in new research, to be
supporty
completed during the coming year, TO prevent medical errors and promote patient safety.
The President also announced that AHQR will increase its current investment in research
focusing on the over and under utilization of services and geographic variation in the delivery
of services by percent over the next year.
mitrok Le devent
Directed the Health Care Financing Administration to Integrate patient safety demonitions
initiatives into the Medicare, Medicaid, and CHIP programs Today, President Clinton
directed the Health Care Financing Administration (HCFA) to develop pilot projects that
promote patient safety and improve health care quality. These new programs will be
designed to reduce medical errors, prevent over and under-utilization of services, and assure
the use of the most recent treatment protocols in the Medicaid, Medicare, and CHIP
programs.
will authority
Announced he would sign legislation expanding the ability of the Agency for Health
Care Quality and Research to explore issues related to patient safety. Today, the
President announced that in the coming days, he would sign legislation that provides new
authority to AHQR to explore on issues related to patient safety, including a specific
directive to conduct research on medical errors. The legislation also eliminates the funding
limit for projects financed by the Center for Education and Research on Therapeutics,
allowing AHQR to increase its investment on research on the prevention of adverse medical
events related to the use of pharmaceuticals.
E
requee chors
efor
Directed the Office of Management and Budget to invest in health care quality and
schely
patient safety initiatives when developing the FY 2001 budget. Today, the President
directed the Office of Management and Budget to work with the Domestic Policy Council
overallan
and the Department of Health and Human Services to develop initiatives within the context
of the FY 2001 budget that build on and enhance the ongoing work of the Outs and to
develop models of applied research that can be implemented in the public and private sectors.
outly
THE CLINTON-GORE ADMINISTRATION'S LONGSTANDING COMMITMENT TO
IMPROVING HEALTH CARE QUALITY. Assuring quality through providing patient
import
protections is a longstanding priority for the Clinton-Gore Administration. Over the past two
years resident Clinton and Vice President Gore have provided critical consumer protections to
the 85 million Americans enrolled in Federal health plans and set the stage for the Congress to
pass a strong, enforceable, Patients' Bill of Rights. In March of 1998, the President established
the Quality Interagency Coordination Task Force, which has been instrumental in developing
disease management protocols that have been adopted nationwide. The Vice President launched
a public-private body known as the Quality Forum to coordinate Federal quality improvement
efforts with the private sector to provide consumers with a consistent set of standards in order to
base their health care choices on quality - not cost. In addition, the Departments of Defense,
Commerce, and Veterans Affairs have been leaders in employing information technology to
efinance their ability to provide higher quality of care to patients.
Etonole
A
PHOTOCOPY
PRESERVATION
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. note
re: phone number (1 page)
n.d.
P6/b(6)
COLLECTION:
Clinton Presidential Records
Domestic Policy Council
Devorah Adler
OA/Box Number: 20470
FOLDER TITLE:
Errors [Folder 4]
2012-0463-S
rc747
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information |(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office |(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA|
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions |(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells ((b)(9) of the FOIA]
RR. Document will be reviewed upon request.
http://www.pub.whitehouse.gov/uri-../oma.eop.gov.us/1998/3/17/3.text.l
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
March 13, 1998
REMARKS BY THE PRESIDENT
ON HEALTH CARE QUALITY
The East Room
2:45 P.M. EST
THE PRESIDENT: Thank you very much. Mr. Vice President, thank
you for your work on this issue and your interest in it. I thank
Secretary Shalala, Secretary Herman, Secretary West, the members of
the White House staff who worked on this. But especially let me thank
the members of the commission and the Executive Director of the
commission, Janet Corrigan. They have done a remarkable citizen
service for the people of the United States of America and we're all
very grateful to them. (Applause.)
As we approach a new century with all its stunning advances in
science and technology, we know that many of them will come in medicine
and health. We must act now to spread these breakthroughs and improve
the quality of health care for every American. I accept the
commission's report. I endorse your recommendations.
For five years we have worked to expand access to quality health
care for the American people, step by step: health insurance coverage
for people who move between jobs; expanded health care coverage for
millions of children; strengthened Medicare with more preventive
benefits. Last year, as the Vice President said, this commission
recommended a Patient's Bill of Rights. Last month I acted to ensure
by executive order that one-third of all Americans -- those in Medicare,
Medicaid, veterans health care systems and other federal plans -- enjoy
the benefits of this Patient's Bill of Rights.
Now these protections must be extended to all Americans. And in
the remaining 68 days of this congressional session, Congress must take
the next step and make the Patient's Bill of Rights the law of the
land. (Applause.)
Now, as you have told America in this report, we must also seize
this moment of opportunity to improve the quality of health care for
all our people. For all its strengths, our health care system still
is plagued by avoidable errors -- overused and underused procedures and
gaps in the quality of care. For example, when hundreds of thousands
of Americans are needlessly injured while in the hospital, when 18,000
Americans die of heart attacks that did not have to be fatal, when
80,000 women undergo unnecessary hysterectomies every year, surely we
can do better.
This commission has drawn a road map for higher quality
across American health care. Above all, our nation must develop
uniform national standards so that health plans can compete on
quality, not just cost; and so that health care consumers can judge
for themselves. This is the best way to assure quality health care
for all Americans.
We can take three steps to advance these high health care
1 of 2
12/1/1999 9:12 AM
http://www.pub.whitehouse.gov/uri-./oma.eop.gov.us/1998/3/17/3.te.f.l
standards. First, health care quality standards should be set at a
forum bringing together providers, business and labor, consumers,
insurers and government. I've asked the Vice President to convene
this health care quality forum this June.
Second, I'm ordering federal agencies to create a task force to
find ways to improve quality in the health care systems that we
operate. The federal government must lead the way in lifting health
care quality for all our people.
Third, I support this commission's recommendation to create a
permanent Health Care Quality Council to set new goals and track our
progress in meeting those goals. A council should be established by
any health care quality legislation enacted this year.
We can make this year a time of real achievement in our mission
to improve health care for every American. The American health care
system has been the best in the world in the 20th century. If we press
forward with medical research, enact a Patient's Bill of Rights, insist
on high quality everywhere in America, continue to expand quality
affordable coverage, protect and preserve Medicare and Medicaid, we can
make American health care the best in the world in the 21st century.
Now I intend to sign an executive order to all the relevant
agencies to make sure they work together to develop the standards you
recommend for quality health care, first for those whom we reach, and
hopefully as a model for all Americans.
Again, I thank this commission. I ask the people and the members
of the press here present to remember just the single instances I cited
from the commission's report of examples where we still have serious
quality changes. And I ask you all to rededicate yourself to this
purpose on this day.
Thank you very much. (Applause.)
END
2:52 P.M. EST
2 of 2
12/1/1999 9:12 AM
001
sted for comments
sent to HHS/
by 3pm FRiday
DRAFT: December 7, 1999
DOLtonight.
EXECUTIVE MEMORANDUM FOR THE QUALITY INTERAGENCY COORDINATION
TASK FORCE
SUBJECT:
IMPROVING HEALTH CARE QUALITY AND ENSURING PATIENT
SAFETY
Assuring quality through patient protections is a longstanding priority for this Administration.
Over the past two years, with the invaluable assistance of the Vice President, Secretary Shalala
and Secretary Herman, this Administration has provided critical consumer protections to the 85
million Americans enrolled in Federal health plans and set the stage for the Congress to pass a
strong, enforceable, Patients' Bill of Rights. Equally as important as assuring high quality health
care services, however, is improving the quality of the services.
tens of
Inappropriate utilization of services, unnecessary variations in the delivery of health care
services, and preventable medical errors are responsible for thousands of deaths, unnecessary
illnesses, and instances of prolonged disability annually. Early detection and appropriate
treatment for illnesses such as diabetes, breast and cervical cancer, and heart attacks can reduce
mortality by over 40 percent. Millions of Americans receive health care services, such as
unnecessary or inappropriate prescriptions or surgeries, that endanger health and increase costs.
In addition, there is a continuing pattern of wide variation in health care practice, including
regional variations, clearly indicating that the practice of health care has not caught up with the
science of health care.
Preventable medical errors present an extraordinary example of the importance of efforts to
ensure the safety of patients and the delivery of high quality health care services. A recent study
by the Institute of Medicine indicates that over half of the adverse medical events occurring each
year are due to preventable medical errors, placing tene of thousands of Americans at
unnecessary risk. More people die each year as a result of medical errors than from motor
vehicle accidents, breast cancer, or AIDS. The cost associated with these unnecessary errors in
lost income, disability, and health care costs is as much as $29 billion annually. The financial
impact of these errors is compounded by the cost of patients' loss of trust in the health care
system, the physical and psychological discomfort associated with longer hospital stays or
permanent disability, reduced school attendance, and lower levels of population health status.
Last year, in order to begin to address these issues, alowly 1 established the Quality Interagency
Coordination Task Force (QuIC), which is responsible for the dissemination of information on
evidence based medical research, and/has been instrumental in developing disease management
protocols that have been adopted nationwide. The Vice President launched a public-private body
rying
known as the Quality Forum DO coordinate our quality improvement efforts with the private
sector to provide consumers with a consistent set of standards in order to base their health care
choices on quality outcomes - not just cost. Although they have only been in operation for a
short period of time, these entities are well on their way to making contributions to improving
the delivery of high quality health care. In addition, the Departments of Defense, Commerce,
and Veterans Affairs have been leaders in employing information technology to enhance their
ability to provide higher quality of care to patients. However, it /s/clear that more must be done
Frank,
th IOM report m/2
undosers the for
that We
to
cuser
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helh
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system does on our
of reducly ecroro, improve safety have quility
12/03/99 18:34 FAX 202 219 6531
ODAS
001
U.S. Department of Labor
Pension and Wellare Benefits Administration
Washington, DC 20210
GREAT TEXT
DATE: 12/
TO: Devora
(Name)
(Company)
(Room/Suite #)
456-5557
(Phone #)
(Fax #)
FROM:
KAYE Pestaina
DAN MAGUIRE
U.S. Department of Labor
Pension and Welfare Benefits Administration
200 Constitution Avenue, N.W. - Room N5677
Washington, D.C. 20210
TOTAL NUMBER OF PAGES, INCLUDING THIS PAGE:
3
MY FAX NUMBER: (202) 219-6531
FOR CONFIRMATION: (202) 219-9044
COMMENTS:
This is the change that I left on
your voice mail eaRlieR Re: exec order on
patient safety.
12/03/99 18:34 FAX 202 219 6531
ODAS
002
DRAFT: December 7, 1999
EXECUTIVE MEMORANDUM FOR THE QUALITY INTERAGENCY COORDINATION
TASK FORCE
SUBJECT: IMPROVING HEALTH CARE QUALITY AND ENSURING PATIENT
SAFETY
Assuring quality through patient protections is a longstanding priority for this Administration
Over the past two years, with the invaluable assistance of the Vice President, Secretary Shalala
and Secretary Herman, this Administration has provided critical consumer protections to the 85
million Americans enrolled in Federal health plans and set the stage for the Congress to pass a
strong, enforceable, Patients' Bill of Rights. Equally as important as assuring high quality health
care services, however, is improving the quality of the services.
Inappropriate utilization of services, unnecessary variations in the delivery of health care
services, and preventable medical errors are responsible for thousands of deaths, unnecessary
illnesses, and instances of prolonged disability annually. Early detection and appropriate
treatment for illnesses such as diabetes, breast and cervical cancer, and heart attacks can reduce
mortality by over 40 percent. Millions of Americans receive health care services, such as
unnecessary or inappropriate prescriptions or surgeries that endanger health and increase costs.
In addition, there is a continuing pattern of wide variation in health care practice, including
regional variations, clearly indicating that the practice of health care has not caught up with the
science of health care.
Preventable medical errors present an extraordinary example of the importance of efforts to
ensure the safety of patients and the delivery of high quality health care services. A recent study
by the Institute of Medicine indicates that over half of the adverse medical events occurring each
year are due to preventable medical errors, placing tens of thousands of Americans at
unnecessary risk. More people die each year as a result of medical errors than from motor
vehicle accidents, breast cancer, or AIDS. The cost associated with these unnecessary errors in
lost income, disability, and health care costs is as much as $29 billion annually. The financial
impact of these errors is compounded by the cost of patients' loss of trust in the health care
system, the physical and psychological discomfort associated with longer hospital stays or
permanent disability, reduced school attendance, and lower levels of population health status.
Last year, in order to begin to address these issues, I established the Quality Interagency
Coordination Task Force (QuIC), which is responsible for the dissemination of information on
evidence based medical research, and has been instrumental in developing disease management
protocols that have been adopted nationwide. The Vice President launched a public-private body
known as the Quality Forum to coordinate our quality improvement efforts with the private
sector to provide consumers with a consistent set of standards in order to base their health care
choices on quality outcomes not ust cost Although they have only been in operation for a
short period of time, these entities are well on their way to making contributions to improving
the delivery of high quality health care. In addition, the Departments of Defense, Commerce,
and Veterans Affairs have been leaders in employing information technology to enhance their
ability to provide higher quality of care to patients. However, it is clear that more must be done.
10/300
EAS 20:51 12/02/99
12/03/99 18:35 FAX 202 219 6531
ODAS
003
Computerizing and streamlining health care processes can improve health care quality, eliminate
dangerous medical errors, lower costs by improving communications between doctors,
eliminating redundant tests and procedures, and building automatic safeguards against harmful
drug interactions and other adverse side effects into the treatment process. Despite this fact, very
few public and private health plans, hospitals, and employers use these new techniques.
Therefore, I hereby direct the Quality Interagency Coordination Task Force, to report to me a set
of recommendations on specific actions to improve health care outcomes and prevent medical
errors in both the public and private sectors in a manner that does not unnecessarily and
inappropriately infringe upon patient privacy in any way. This report shall:
Identify prevalent medical errors. that can be prevented through the use of decision support
systems. such as patient monitoring and reminder systems;
Propose steps to eliminate barriers preventing adoption of effective information technology
systems in different health care settings in both the public and private sectors;
Propose a strategy to reduce medical errors in Federal health care programs that will reduce
medical errors and ensure patient safety:
Detail specific actions that the Federal government can take with the private sector to reduce
medical errors and improve patient safety nationwide, including continued collaboration on
health care quality issues with the QUIC, the Quality Forum, and the National Center for
Vital Statistics; and
Provide technical support to the Health Care Financing Administration in the development of
pilot projects implementing patient safety initiatives in Medicare, Medicaid, and CHIP.
Evaluate the feasibility and advisability of the recommendations of the Institute of
Medicine's Quality of Health Care in America Committee on patient safety, including the:
Creation of a Center for Patient Safety in the Agency for Healthcare Research and
Quality;
Establishment of a nationwide mandatory reporting system on adverse events that result
in death or serious harm to patients;
Encouragement of the development of voluntary reporting systems on medical errors;
Extension of peer review protections to data related to patient safety;
Inclusion of patient safety components in performance standards for health care
organizations and health care professionals;
Requirement for the Food and Drug Administration to consider patient safety in pre and
post-marketing processes for pharmaceuticals; and
Encouragement of private health care organizations to establish patient safety programs
with defined executive responsibility and to implement proven medication safety
practices.
and the Department of Labor
I direct the Department of Health and Human Services to serve as the coordinating agency to
assist in the development and integration of recommendations and to report back to me within 60
days. The recommended actions should lay the foundation for a national system that prevents
adverse medical events before they occur.
10/001
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12/03/99 18:28 FAX 202 401 7321
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JENNINGS
004
Therefore, I hereby direct the Quality Interagency Coordination Task Force to report to me with
a set of recommendations relating to medical errors and patient safety. These recommendations
should include specific actions to improve health care outcomes and prevent medical errors in
both the public and private sectors in a manner consistent with the strong privacy protections that
we have proposed. This report should
Identify additional strategies to reduce medical errors in federal health care programs.
/ recommendence Dr
thats
Identify prevalent medical errors that can be prevented through the use of decision
L
support systems, such as patient monitoring, computerized information systems, and
reminder systems.
Identify opportunities the Federal government can take to reduce medical errors and
5
improve patient safety nationwide through collaborations with the private sector,
including the Quality Forum.
Evaluate the feasibility and advisability of the recommendations on patient safety issued
by the Institute of Medicine's Quality of Health Care in America Committee.
1 direct the Secretary of Health and Human Services to coordinate the development and
integration of the recommendations and to report back to me within 60 days.
Identify barrier
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02/17/00 12:41 FAX 630 792 3090
JOINT COMMISSION
001
1 Renaissance Blvd.
Joint Commission on
Oakbrook Terrace, II 60181
Phone: (630) 792-5269
Accreditation of
Fax: (630) 792-4269
Healthcare
Organizations
Fax
To:
Devora Adler
From: Karen Eberspacher
Fax: 202-456-5557
Date: February 17, 2000
Pages: 28
Re:
Sentinel Event Questionnaire
Urgent
For Review
Please Comment
Please Reply
Please Recycle
Comments: Please call me if you have not received all the pages.
02/17/00 12:41 FAX 630 792 3090
JOINT COMMISSION
002
Sentinel Event Questionnaire Executive Summary
During March of 1999, state relations conducted a survey of state agencies to identify state
requirements related to sentinel event reporting. The following represents significant
findings from this survey.
Methodology:
A written survey was distributed to 50 states, Puerto Rico, and the District of
Columbia. Nonrespondants were contacted by phone.
Requirements for reporting of health care sentinel events to the state:
- 32 states, Puerto Rico, and the District of Columbia (67%) have responded either to
the written survey or follow up phone survey.
- 16 states and D.C. (33%) responded that there is a law that requires reporting of
sentinel events: Alabama, Alaska, District of Columbia, Florida, Idaho, lowa,
Louisiana, Massachusetts, Minnesota, Nevada, New Jersey, New York,
Pennsylvania, Tennessee, Texas, Washington, and Wisconsin.
-
15 states and Puerto Rico (31%) responded there was no law currently in place that
requires reporting of sentinel events to the state - California, Hawaii, Kentucky,
Mississippi, Missouri, Montana, New Hampshire, New Mexico, North Dakota,
Oklahoma, Oregon, Utah, Vermont, West Virginia, and Wyoming.
Categories of sentinel events required to be reported to states:
- report unexpected patient deaths (including suicide and restraint deaths) - 13
states and D.C. (27%) - Alabama, District of Columbia, Florida, Hawaii, Idaho, lowa,
Louisiana, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania,
Washington, and Wisconsin.
- report wrong site surgery - 5 states (10%) - Florida, Massachusetts, New Jersey,
New York, and Washington.
- report infant abduction and wrong infant discharge - 6 states and D.C. (13%) -
California, District of Columbia, Massachusetts, New Jersey, New York,
Pennsylvania, and Washington.
- report rape of a patient - 9 states and D.C. (19%) - Alabama, District of Columbia,
Idaho, Louisiana, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania,
and Washington.
- report hemolytic transfusion reaction - 6 states and D.C. (13%) - District of
Columbia, Florida, Massachusetts, New Jersey, New York, Pennsylvania, and
Washington.
Page 1
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003
Sentinel Event Questionnaire Executive Summary
- report major loss function due to treatment or surgery - 5 states and D.C. (12%)
- District of Columbia, Florida, Massachusetts, New Jersey, New York, and
Washington.
- Other sentinel events reported to states include abuse, neglect and exploitation.
Categories of health care organizations that submit data to the state:
- general and acute care hospitals - 16 states and D.C. (33%) - Alaska, California,
District of Columbia, Hawaii, Idaho, Louisiana, Massachusetts, Minnesota, Nevada,
New Jersey, New Mexico, New York, Pennsylvania, Tennessee, Texas, Utah, and
Washington.
- psychiatric hospitals or residential psychiatric centers - 13 states and D.C.
(27%) - California, District of Columbia, Hawaii, Idaho, Louisiana, Minnesota,
Nevada, New Jersey, New Mexico, Oklahoma, Pennsylvania, Tennessee, Texas,
and Utah.
- ambulatory surgery clinics - 10 states (19%) - California, Minnesota, Nevada, New
Jersey, New Mexico, New York, Pennsylvania, Tennessee, Texas and Utah.
- outpatient mental health clinics - 3 states (6%) - New Mexico, Oklahoma, and
Texas.
- nursing homes - 16 states and D.C. (33%) - Alabama, Alaska, California, District of
Columbia, Hawaii, Idaho, Indiana, Louisiana, Massachusetts, Minnesota, Nevada,
New Jersey, New Mexico, Oklahoma, Pennsylvania, Tennessee, and Utah.
- home health agencies - 12 states and D.C. (25%) - Alaska, California, District of
Columbia, Idaho, Louisiana, Minnesota, Nevada, New Jersey, New Mexico,
Oklahoma, Pennsylvania, Tennessee, and Utah.
- laboratories - 2 states (4%) - Massachusetts and Nevada.
- Other health care organizations include intermediate care facilities, developmentally
disabled, group homes, CD, birthing centers, ESRD and group homes for child care.
Other significant findings:
Information is maintained in databases by 12 states (23%) - Alabama, Alaska, Florida,
Massachusetts, Minnesota, Nevada, New Hampshire, New York, Tennessee, Texas,
Utah and Wisconsin.
18 states and D.C. (37%) indicated that a follow up is done to assure corrective action -
Alabama, Alaska, District of Columbia, Florida, Hawaii, Idaho, lowa, Louisiana,
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Sentinel Event Questionnaire Executive Summary
Massachusetts, Nevada, New Hampshire, New Jersey, New York, Pennsylvania,
Tennessee, Texas, Utah, Washington, and Wisconsin.
Frequency of a state survey based on a reported event include:
- 5 states and D.C. (12%) responded that a state survey is done in all cases -
Alabama, Alaska, District of Columbia, Idaho, Nevada, and Texas.
- 13 states (25%) responded that a state survey is done in some cases - Florida,
Hawaii, Louisiana, Massachusetts, Minnesota, New Hampshire, New Jersey, New
York, Pennsylvania, Tennessee, Utah, Washington, and Wisconsin.
- 1 state (2%) requires a plan of correction - Florida.
- 4 states (8%) refer the facility to other agencies - California, Hawaii, Massachusetts,
and Minnesota.
- States actions after review of events:
2 states (4%) give fines - New Jersey and New York.
1 state (2%) revokes licenses - Tennessee.
12 states (23%) have sanctioned a facility - These sanctions range from an
average of 1-3 times a year for the following states: Florida, Idaho, lowa and
Wisconsin.
15 states (29%) disclose information to the public, typically upon request.
- Types of information disclosed are complaint investigation findings, incident reports,
survey reports, statement of deficiencies and plans of correction.
States indicated that a failure to submit data or report occurrences could trigger:
- Actual facility citation
- Deficiency citation
- Warning letters
- Fines
- Corrective action plans
States that require healthcare organizations to report other event data (not necessarily
similar to Joint Commission's Sentinel Event definition) are Alabama, Alaska, Florida,
Hawaii, lowa, Louisiana, Massachusetts, Minnesota, Nevada, New Mexico, New York,
Tennessee, Texas and Wisconsin (14 states, 27%).
Percentage of facilities in 6 states (12%) that report data:
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005
Sentinel Event Questionnaire Executive Summary
State
Percentage
Hawaii
91%
Massachusetts
100%
New Mexico
5%
New York
100%
Tennessee
>5%
Wisconsin
>5%
Number of adverse events reported in 10 states (19%) included:
State
1997
1998
Alaska
52
19
Florida
~5,000
~5,000
lowa
6-12
6-12
Massachusetts
~350
~425
Minnesota
3,873
3,394
New Mexico
50
50
New York
~15,000
~15,000
Tennessee
~1,500
~1,500
Texas
343
369
Wisconsin
65
79
12 states (23%) responded that the reporting of adverse events has been useful.
- Benefits of reporting cited included:
corrective measures are implemented as a result of reporting,
legally required patient care quality standards are being met,
provider awareness has increased that, in return, prevents occurrences,
preventive action has been taken.
Page 4
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006
Sentinel Event Questionnaire Executive Summary
Sentinel Event Questionnaire
Please reply via facsimile (630) 792-4269 by 3/11/99, or call us and we will take your answers over the phone.
The Joint Commission on Accreditation of Healthcare Organizations is asking that you please take a moment to
fill out a brief survey to determine the effectiveness of laws and regulations that address unexpected occurrences
involving death or serious physical or psychological injury (i.e., sentinel events, adverse incidents). We would
like information about actual reporting, compliance levels, how information gets used, and access to the data.
1)
Do you have a law that requires reporting of health care sentinel events to the state?
Yes
No
(By sentinel event we mean: unexpected patient deaths (including suicide and restraint
death), wrong site surgery, infant abduction or wrong infant discharge, rape of a patient, hemolytic
transfusion reaction,
major loss of function due to treatment or surgery.)
2)
What kinds of events are reported? (Check all that apply)
unexpected patient deaths (including suicide and restraint death)
wrong site surgery
infant abduction or wrong infant discharge
rape of a patient
hemolytic transfusion reaction
major loss of function due to treatment or surgery
others
3)
What categories of health care organizations must report? (Check all that apply)
general and acute care hospitals
psychiatric hospitals or residential psychiatric centers
ambulatory surgery centers
outpatient mental health centers
nursing homes
home health agencies
laboratories
pharmacies
others
4)
What is done with the information reported?
Is information entered into a database? Yes
No
Number of cases currently in the database.
Do you follow up to assure corrective action? Yes
No
Is a state survey done? In all cases
In some cases
No
Other action by the state?
5)
Is information disclosed to the public? Yes
No
Type of information
6)
What do you do if organizations do not submit data or report occurrences?
7)
How many times have you sanctioned a facility for failure to report each year?
(approximate)
8)
How many organizations have reported data?
What percent of facilities does this represent?
9)
How many adverse events were reported in 1997
and 1998
?
10)
Has the program been useful in improving care and reducing risks for errors?
Yes
No
Why or why not?
Page 5
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
002. form
re: Sentinel Event Questionnaire Executive Summary (partial) (1 page)
02/17/2000
P6/b(6)
COLLECTION:
Clinton Presidential Records
Domestic Policy Council
Devorah Adler
OA/Box Number: 20470
FOLDER TITLE:
Errors [Folder 4]
2012-0463-S
rc747
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA]
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy |(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells ((b)(9) of the FOIA]
RR. Document will be reviewed upon request.
02/17/00 12:42 FAX 630 792 3090
JOINT COMMISSION
$
007
Sentinel Event Questionnaire Executive Summary
State:
Name:
Title:
Phone:
Fax:
Thank you so much for participating. If you have any questions, please call (630) 792-5269 the Division
of Government Relations & External Affairs and ask to speak with Donna Nowakowski, Director; Kristin
Hellquist, Associate Director; Karen Eberspacher, Coordinator; or Rita Fernandez-Sturm, Intern.
karen
LOOZ]
P6/(b)(6)
Page 6
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JOINT COMMISSION
1.
008
Sentinel Event Questionnaire Executive Summary
Sentinel Event Questionnaire Responses
1. Do you have a law that requires reporting of health care sentinel events to
the state?
STATE
Yes
No
Comments
Alabama
Alaska
Arizona
Arkansas
Wouldn't share
information.
California
Colorado
Connecticut
Delaware
District of
Columbia
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
lowa
Kansas
Kentucky
>
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Page 7
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JOINT COMMISSION
5
009
Sentinel Event Questionnaire Executive Summary
STATE
Yes
No
Comments
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Puerto Rico
Totals
18
17
Page 8
2. What kinds of events are reported?
(Check all that apply)
Unexpected
Infant
patient deaths
Major loss
Wrong
abduction
(including
Hemolytic
function
STATE
site
Rape of
suicide and
or wrong
transfusion
due to
Others
infant
a patient
surgery
reaction
treatment
restraint
deaths
discharge
or surgery
02/17/00 12:43 FAX 630 792 3090
Alabama
serious injuries, burns
Alaska
abuse/neglect for vulnerable adults
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of
Columbia
Florida
wrong pt surg/surg repair
Georgia
Hawaii
JOINT COMMISSION
allegations of abuse, neglect,
misappropriation of funds
Idaho
patient abuse/ neglect/ exploitation
Illinois
Indiana
Iowa
elopement
Kansas
Kentucky
Louisiana
abuse, injuries of unknown origin
Maine
Maryland
Massachusetts
a We have circular letters for hospitals
and nursing home reporting-call if you
want copies."
Michigan
Minnesota
abuse, neglect exploitation (financial)
Mississippi
OTO
Unexpected
Infant
patient deaths
Major loss
Wrong
abduction
Hemolytic
function
STATE
(including
site
Rape of
or wrong
transfusion
due to
Others
suicide and
restraint
surgery
infant
a patient
reaction
treatment
deaths
discharge
or surgery
Missouri
Montana
Nebraska
Nevada
abuse, exploitation, neglect
02/17/00 12:43 FAX 630 792 3090
New
Hampshire
New Jersey
anesthesia related events;
disasters related to interruption of
service
New Mexico
Abuse, neglect , exploitation
New York
(serious occurrence warranting
DOH/DMH notification)
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
JOINT COMMISSION
Pennsylvania
serious compromise patient care
Rhode Island
South Carolina
South Dakota
Patient elopement
Tennessee
unusual occurrences or events (left to
org. discretion)
Texas
abuse and neglect
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
suicides, restraint, isolation and
psychotropic medication deaths
Wyoming
Totals
15
6
5.
7
11
8
6
TTO
3. What categories of health care organizations must report?
(Check all that apply)
General
Psychiatric
ASC
CM
Nursing
Home
Labora-
Pharm-
Others
and acute
hospitals or
HCS
homes
health
tories
cies
STATE
care
residential
agencies
hospitals
psychiatric
centers
Alabama
02/17/00 12:43 FAX 630 792 3090
Alaska
Arizona
Arkansas
California
ICF, DD, daycare CD
Colorado
Connecticut
Delaware
District of
ICF
Columbia
Florida
Georgia
Hawaii
ICF
JOINT COMMISSION
Idaho
ICF
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
\
Maine
Maryland
Massachusetts
Michigan
Minnesota
Group homes, MR/DD, CD
Mississippi
Missouri
Montana
5.
Nebraska
012
General
Psychiatric
ASC
CM
Nursing
Home
Labora-
Pharm-
Others
and acute
hospitals or
HCS
homes
health
tories
cies
STATE
care
residential
agencies
hospitals
psychiatric
centers
Nevada
All licensed facilities
New
Hampshire
New Jersey
02/17/00 12:44 FAX 630 792 3090
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
centers DD, SA, group homes
child care
Oregon
Pennsylvania
birth center
Rhode Island
South Carolina
South Dakota
Assisted Living, Chemical
Dependency Inpatient Centers
JOINT COMMISSION
Tennessee
Texas
ESRD
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Utah?
013
02/17/00 12:44 FAX 630 792 3090
JOINT COMMISSION
014
4. What is done with the information reported?
Number of
Do you follow
Is information
cases
up to assure
Is a state
Other action
STATE
entered into a
currently in
corrective
survey done?
by the state
database?
database.
action?
Alabama
Yes
19
Yes
In all cases
Alaska
Keep log
?
Yes
In all cases
primarily,
nursing homes
Arizona
Arkansas
California
Unusual
occurrences
are reported
by facilities to
L&C District
Offices.
Colorado
Connecticut
Delaware
District of
Yes
Yes
Columbia
Florida
Yes
5000
Yes
In some cases
Plan of
approx/yr
correction
Georgia
Hawaii
No
Yes
In some cases
Referred to
other agencies
Idaho
No
Yes
In all cases
Illinois
Indiana
Iowa
No
Yes
Kansas
Kentucky
Louisiana
No
?
Yes
In some cases
Require
facility
investigation
and report
Maine
Maryland
Massachusetts
Yes
Hospitals-
Some
In some cases
Referral to
2-3000
other agencies
incidents
(including
complaints)
Nursing
homes-About
10,000/year
Michigan
Minnesota
Yes
20,000 past 5
In some cases
Refer reports
yrs
to other
agencies
Mississippi
Missouri
Montana
02/17/00 12:44 FAX 630 792 3090
JOINT COMMISSION
015
Number of
Do you follow
Is information
cases
up to assure
Is a state
Other action
STATE
entered into a
currently in
corrective
survey done?
by the state
database?
database.
action?
Nebraska
Nevada
Yes
Yes
In all cases
New Hampshire
Yes
100
Yes
In some cases
New Jersey
No
N/A
Yes
In some cases
Warning
letters, fines
New Mexico
New York
Yes
8,000 approx.
Yes
In some cases
fines
355 in
categories
noted above
North Carolina
North Dakota
No
Yes
In some cases
Ohio
Oklahoma
Oregon
Pennsylvania
No
Yes
In some cases
Rhode Island
South Carolina
South Dakota
Tennessee
File kept
Yes
In some cases
Revoke
licenses,
summary
suspension
Texas
Yes
Standard
Yes
In all cases
N/A
report not
available
Utah
Yes,
Yes, review
In some cases
substantiated
only if
findings
statement of
finding is
issued
Vermont
Virginia
Washington
No
0
Yes
In some cases
West Virginia
Wisconsin
Yes
65-75 per year
Yes
In some cases
Actions range
by severity.
The Care
Specialists
and
Committee
review deaths
quarterly.
Inpatient has
on site survey/
outpatient
varies
Wyoming
02/17/00 12:44 FAX 630 792 3090
JOINT COMMISSION
5.
016
5. Is information disclosed to the public?
STATE
Yes, type of information
No
Alabama
Yes, HCFA 2567
Alaska
Arizona
Arkansas
California
Aggregate data: complaint investigation
findings, number of complaints, and
categories are disclosed to the public
upon request.
Colorado
Connecticut
Delaware
District of
Yes
Columbia
Florida
On site survey; cited deficiencies.
Georgia
Hawaii
No
Idaho
survey reports / complaint letters
Illinois
Indiana
lowa
No
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Yes, upon request (FOIA) - incidents
reports, complaints, reports of
investigations, statements of deficiency,
plans of correction.
Michigan
Minnesota
Yes
Mississippi
Missouri
Montana
Nebraska
Yes
Nevada
Yes, statement of deficiencies and plan
of correction.
New Hampshire
New Jersey
Yes, report of incident and/or survey
report, hospital fine are listed on internet
New Mexico
Yes, if substantiated
New York
Yes, findings, hospital specific
aggregate data
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
No
Rhode Island
02/17/00 12:44 FAX 630 792 3090
JOINT COMMISSION
017
STATE
Yes, type of information
No
South Carolina
South Dakota
Yes, only on HCFA 2567
Tennessee
Texas
Yes, as mandated by the open records
act
Utah
Yes, substantiated complaints
Vermont
Virginia
Washington
No
West Virginia
Wisconsin
Yes, incident specific (awareness) &
yearly statistical report
Wyoming
(30)
2ʳᵈ
0062
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
018
6. What do you do if organizations do not submit data or report occurrences?
STATE
Alabama
Write deficiencies related to not reporting
Alaska
Facility can be cited monetary or suspension depending on severity
Arizona
Arkansas
California
If facilities fail to report unusual occurrences to the Department the Department
can cite the facility
Colorado
Connecticut
Delaware
District of
Write a deficiency
Columbia
Florida
Cited, given opportunity to correct, subject to fines
Georgia
Hawaii
Providers survey for citations for state/federal program requirements
Idaho
Adverse action/ civil monetary penalties
Illinois
Indiana
lowa
Cite a deficiency
Kansas
Kentucky
Louisiana
Investigation as a complaint, cite deficiencies
Maine
Maryland
Massachusetts
citation of a deficiency
Michigan
Minnesota
State deficiencies may resort to fine
Mississippi
Missouri
Montana
Nebraska
Nevada
Facilities would be cited for deficiencies
New Hampshire
New Jersey
Possible fine and/or warning letter
New Mexico
Cite them
New York
Follow-up surveys
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Has not happened; contact on citation
Rhode Island
South Carolina
South Dakota
Technical assistance on reporting requirements, written warnings, deficiencies
Tennessee
Deficiency given
Texas
A deficiency is given when failure to report is discovered.
Utah
Vermont
Virginia
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
019
STATE
Washington
Cite-require corrective action plan
West Virginia
Wisconsin
cited for violating statutory reporting laws
Wyoming
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
1.
020
7. How many times have you sanctioned a facility for failure to report each
year? (approximate)
STATE
Alabama
23 in 1997 and 13 in 1998
Alaska
0
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of
Columbia
Florida
3x/yr.
Georgia
Hawaii
0
Idaho
1
Illinois
Indiana
lowa
1-2
Kansas
Kentucky
Louisiana
0
Maine
Maryland
Massachusetts
Michigan
Minnesota
Approx. 5
Mississippi
Missouri
Montana
Nebraska
Nevada
Unknown
New Hampshire
New Jersey
Less than 5
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
0
Rhode Island
South Carolina
South Dakota
0
Tennessee
Less than 5%
Texas
N/A
Utah
Vermont
Virginia
Washington
N/A
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
021
STATE
West Virginia
Wisconsin
1-2 per year
Wyoming
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
022
8. (This is a two part question)
How many organizations have
What percent of facilities does this
STATE
reported data?
represent?
Alabama
Numerous
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of
Columbia
Florida
Collects data but gave no numbers
gave no numbers
Georgia
Hawaii
More than 40
91%
Idaho
Does not have database
Does not have database
Illinois
Indiana
lowa
6-12
Kansas
Kentucky
Louisiana
Most nursing homes and intermediate
care facilities
Maine
Maryland
Massachusetts
Approx. 75 hospitals, 500 nursing
All
homes
Michigan
Minnesota
Don't have number
Don't have number
Mississippi
Missouri
Montana
Nebraska
Nevada
Numerous
Numerous
New Hampshire
New Jersey
Unknown, no database
Unknown
New Mexico
50
5%
New York
Approx. 260 hospitals
100% of hospitals
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Don't know, no database
Rhode Island
South Carolina
South Dakota
Stats not kept
Tennessee
Less than 5%
Texas
Information not available
Information not available
Utah
Vermont
Virginia
02/17/00 12:45 FAX 630 792 3090
JOINT COMMISSION
023
How many organizations have
What percent of facilities does this
STATE
reported data?
represent?
Washington
N/A
N/A
West Virginia
Wisconsin
same- mostly adult mental health
under 5%
Wyoming
02/17/00 12:46 FAX 630 792 3090
JOINT COMMISSION
024
9. How many adverse events were reported in
STATE
97'
98'
Comments
Alabama
Alaska
52
19
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of
118 for two years
Columbia
Florida
5,000
5,000
Georgia
Hawaii
Idaho
Illinois
Indiana
lowa
6-12
6-12
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
approx. 350
approx. 425
Hospitals only
Michigan
Minnesota
3,873
3,394
Mississippi
Missouri
Montana
Nebraska
Nevada
Unknown
New Hampshire
New Jersey
Unknown
Unknown
New Mexico
50
50
New York
Approx. 15,000
Approx. 15,000
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
02/17/00 12:46 FAX 630 792 3090
JOINT COMMISSION
025
STATE
97'
98'
Comments
South Carolina
South Dakota
Statistics not kept
Tennessee
Approx. 1,500
Approx. 1,500
Texas
343
369
Utah
Vermont
Virginia
Washington
N/A
N/A
West Virginia
Wisconsin
65
79
Wyoming
02/17/00 12:46 FAX 630 792 3090
JOINT COMMISSION
1.
026
10. Has the program been useful in improving care and reducing risks for
errors?
STATE
Yes
No
Why or why not?
Alabama
Facilities are reporting and corrective
measures are being implemented
Alaska
Organizations are accountable (staff,
administration) raises awareness of issue
Arizona
Arkansas
California
Requiring facilities to report unusual
occurrences to the Department is
important and has been useful. The
investigation of complaints/facility
reported unusual occurrences is a key
component of licensing and Certification's
regulatory and enforcement functions to
ensure that legally required patient care
quality standards are being met.
Colorado
Connecticut
Delaware
District of
Yes, when elopements from a group
Columbia
home increased we insisted on the home
installing and alarm system then they
decreased
Florida
Don't know; many obstacles especially
with politics
Georgia
Hawaii
Providers are more aware of incidents/
prevent situations and take preventive
action
Idaho
Illinois
Indiana
Iowa
Unknown
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Identifying root causes/solutions much of
information has been useful for our
coalition for prevention of medication
errors.
Michigan
Minnesota
Absolutely makes facilities accountable
Mississippi
Missouri
Montana
Nebraska
Nevada
Because citation has a possibility of
sanction with monetary and civil penalties
02/17/00 12:46 FAX 630 792 3090
JOINT COMMISSION
1.
027
STATE
Yes
No
Why or why not?
New Hampshire
New Jersey
New Mexico
Not extensive enough
New York
Program was redesigned and
implemented statewide April 1, 1998 New
York Patient Occurrence Reporting and
Tracking System (NYPORTS)
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Too early to tell; came in effect since 6/98
Rhode Island
South Carolina
South Dakota
Statistics not kept.
Tennessee
Texas
Statistical data not available
Utah
Vermont
Virginia
Washington
New rule-effective today for first time
West Virginia
Wisconsin
Used for alerts, specific incidents
Wyoming
99survey_for_fax.lwp
Michael Coleu AHA
Nancy
Suggested Invitees
Foster
AHCPR(AHRQ) Requests
Donald Berwick; Institute for Healthcare Improvement (also Forum)
Peter Thomas (also Forum)
301
Bruce Bradley, GM (also Forum)
Mark Smith, California Healthcare Foundation
594
Ray Woosley, Georgetown University
1609
IOM People
William Richardson, chair of IOM Committee, Kellogg Foundation
Charles Buck, GE
Christine Cassel, Mt. Sinai in NYC
David Lawrence, Kaiser Foundation Health Plan
Brent James, Intermountain Health Care
Tony Jan
Lucien Leape, Harvard
Mary Wakefield, George Mason University
PROMOCY
revet
QuIC People
Secretaries Shalala and Herman, co-chairs
10M
John Eisenberg (also AHRQ), operating chair
MepecT
Thomas Garthwaite (Acting undersecretary at the VA)
AMA
Sue Bailey (DoD)
Janice Lachance (also Forum)
AHA
ADM Joyce Johnson (Coast Guard)
Paul London (Commerce)
ANA
Business
Forum
Gail Warden, (also IOM)
Labor
Helen Smits
Consumer
Association People
Jordan Cohen, Association of American Medical Colleges
QUAQUALITY
Mary Wooley, Research! America
David Helms, AHSR
Insurance Forum
Charles Kahn, HIAA
Mary Jane England, Washington Business Group on Health (also Forum)
Robert Graham, AAFP
Beverly Malone, ANA
Karen Ignani, AAHP
Tom Reardon, AMA (also Forum)
(NCADA) 3 Kaiser
person on
board
VA
HCFA
8+ + Admin
DOD
OPM OMB
officials
Eisenberg
commerce
London
DOL
Dec 02 99 03:50p
United Hospital Fund
2124940830
p.2
+
United
Hospital Fund
Shaping New York's Health Care:
Information, Philanthropy, Policy.
Enpire State Sudding
350 Fifth Avenue, 2315 Floor
New York, NY 10118-2399
212 494-0700
Fax 212 404-0800
TO:
Chris Jennings
T: 202 456-5560
FROM:
Jim Tallon
DATE:
December 2, Jogg
F: 202 456-5557
Three pages
SUBJECT:
Names
Attached is a list of the Board of Directors of the Quality Forum, and a list of the
members of the Quality Forum Framework Board.
As you will recall, the Framework Board is the "expert group" which will take the lead in
developing a national strategy for quality information.
I have checked the Framework Board members who served on the IOM committee.
Note that Gail Warden, Chairman of the Board of Directors of the Quality Forum, also
served on the IOM committee. I'd suggest that you use him as the lead representative of
the Quality Forum in developing your plans. I've given him a heads-up on our
conversation.
QF
Miscl22