Report
of the Quality Interagency Coordination Task Force (QuIC) to the
President, February 2000
Doing
What Counts for Patient Safety: Federal Actions to Reduce Medical
Errors and Their Impact
Contents
Quality Interagency Coordination Task Force
Executive
Summary and Actions
A National Problem
of Epidemic Proportion
The Clinton–Gore Administration's Commitment to Improving Patient
Safety
Institute of Medicine Recommendations
A Road Map for Action: The Federal Response
Creating a
National Focus to Enhance the Knowledge Base on Patient Safety
Setting Performance Standards and Expectations for Safety
Implementing Safety Systems in Health Care Organizations
Additional Federal Actions to Improve Patient Safety
Conclusion
Compendium
of Action Items
IntroductionErrors: Part of a Broader Quality Agenda
The IOM Report
The President’s Directive
Chapter 1Understanding
Medical Errors
Growing Concerns
About Medical Errors
Definitions and Context
Figure 1. Framework
for Identifying Errors
A Framework
for Thinking About Errors
Lessons from
other industries
Unique aspects of health care errors
Impact of organizational and professional culture
A global challenge
Evidence of Errors
The epidemiology
of medical errors
Adverse events and medical products use or misuse
Current programs to prevent errors
Accomplishments of programs to prevent medical errors
Insufficiency of existing programs
Chapter 2Federal
Response to the IOM Report
National Focus
and Leadership
Center for
Patient Safety-- Actions
Research Planning-- Actions
Identifying
and Learning From Errors
Accountability-- Actions
Learning from Errors
Characteristics of an Ideal Reporting System for Learning-- Actions
Analysis and Feedback
Peer
Review Protections --Actions
Setting Performance
Standards and Expectations for Safety
Raising the
Standards for Health Care Organizations-- Actions
Raising the Standards for Health Care Professionals-- Actions
Safe
Use of Drugs and Devices-- Actions
Implementing
Safety Systems in Health Care Organizations-- Actions
Framework for Reporting Systems
Chapter
3Beyond the IOM Report: Identifying and Implementing Additional
Strategies
Building Public
Awareness of Medical Errors-- Actions
Building Purchasers’ Awareness of the Problem-- Actions
Working with Providers to Improve Patient Safety-- Actions
Using Decision-support Systems and Information Technologies-- Actions
Using Standardized Procedures, Checklists, and the Results of Human
Factors Research-- Actions
Chapter 4Working
with the Private Sector and State Governments
Standards -- Actions
Data Integration--Actions
References
Glossary
Organization
and Acronym Guide
Glossary of Terms
Co-Chairs
Donna Shalala,
Secretary, Department of Health and Human Services
Alexis Herman, Secretary, Department of Labor
Operating
Chair
John Eisenberg,
Director, Agency for Healthcare Research and Quality
Participating
Departments and Agencies
Department of Commerce
Department of Defense
Department of Health and Human Services
Department of Labor
Department of Veterans Affairs
Federal Bureau of Prisons
Federal Trade Commission
National Highway Transportation and Safety Administration
Office of Personnel Management
Office of Management and Budget
United States Coast Guard
Coordination
Officer
Nancy Foster,
Agency for Healthcare Research and Quality
Acknowledgments
The development
of this report by the Quality Interagency Coordination Task Force
involved the efforts of many people from many agencies. Those individuals
listed below, alphabetically by agency, made significant contributions
to the content and form of the report. Many others commented on
drafts of the report and made important contributions to it.
Department
of Health and Human Services
Agency for
Healthcare Research and Quality: Raghu Bukkapatnam, Carolyn
Clancy, John M. Eisenberg, Nancy Foster, Irene Fraser, Howard Holland,
Marge Keyes, David I. Lewin, Karen J. Midgail, Gregg Meyer, Ronald
Rabbu, Heddy Reid, Mary Rolston, Ning Tang, Christine Williams,
Paula Zeller
Centers for
Disease Control and Prevention: Irma Arispi, Blake M. Caldwell,
Scott Deitchman, Linda Delmo, Julie Gerberding, Roger Rosa, Kenneth
Schachter, Dana Silverman, Steven L. Solomon, Rosemary Sokas
Food and
Drug Administration: Rosalie Bright, Nancy Derr, Susan Ellenberg,
Marilyn Flack, Susan Gardner, Melvyn Greberman, Anne Henig, Mary
Leary, Catherine Lorraine, Susan K. Meadows, Karen Meister, Theresa
Mullin, Jerry Phillips, Chester Trybus, Janet Woodcock
Health Care
Financing Administration: Robert Berenson, Judith L. Bragdon,
Valerie Mattison Brown, Carol Cronin, Tim Cuerdon, Stephanie Dyson,
Frank Emerson, Connie Forster, Stephen Jencks, Jeffrey L. Kang,
Larry Kessler, David Miranda, Barbara Paul, Doug Rimel, Ideanna
Sarsitis, Alfreda Staton, Aaron Stopak, Rachael Weinstein
Health Resources
and Services Administration: Barbara Brookmyer, Forrest W. Calico,
Felicia Collins, M. Ann Drum, David E. Heppel, Michael Johnson,
Ruth Kahn, Joel T. Levine, Suzanne M. Leous, Louis Emmet Mahoney,
Laura A. McNally, William A. Robinson, Vincent C. Rogers, David
B. Snyder
National
Institutes of Health: David K. Henderson, Laura M. Lee
Office of
the Secretary: Gary Claxton, Jane Horvath, Nicole Lurie, Beverly
Malone, Lisa Rovin
Substance
Abuse and Mental Health Services Administration: Paolo del Vecchio,
Jennifer Fiedelholtz, Alan Trachtenberg
United States
Coast Guard
Gary Kaplowitz
Department
of Commerce
Paul London
Department
of Defense
Sue Bailey,
Timothy Corcoran, Frank Maguire, John Mazzuchi, Aron Primack, Wyatt
Smith, Frances Stewart
Department
of Labor
Patricia Arzuaga,
Jordan Barab, Charles Cortinovis, Elise Handelman, Leslie Kramerich,
Deborah Milne
Office of
Personnel Management
Abby Block,
W. Edward Flynn, Frank Titus, Ellen Tunstall
Department
of Veterans Affairs
James P. Bagian,
Thomas Garthwaite, John Gosbee, Caryl Z. Lee, Jonathan Perlin
Doing
What Counts for Patient Safety: Federal Actions to Reduce Medical
Errors and Their Impact
To
Err is Human: Building a Safer Health System, a report released
late last year by the Institute of Medicine (IOM), shocked the Nation
by estimating that up to 98,000 Americans die each year as a result
of preventable medical errors. The report concludes that the majority
of these errors are the result of systemic problems rather than
poor performance by individual providers, and outlined a four-pronged
approach to prevent medical mistakes and improve patient safety.
On December
7, President Clinton directed the Quality Interagency Coordination
Task Force (QuIC) to evaluate the recommendations in To Err is
Human and to respond with a strategy to identify prevalent threats
to patient safety and reduce medical errors. This report responds
to the President’s request and provides an action plan to implement
Administration initiatives designed to help prevent mistakes in
the Nation’s health care delivery system.
A National
Problem of Epidemic Proportion
It is clear
that, although the United States provides some of the best health
care in the world, the numbers of errors in health care are at unacceptably
high levels. The Institute of Medicine’s report estimates that more
than half of the adverse medical events occurring each year are
due to preventable medical errors, causing the death of tens of
thousands. The cost associated with these errors in lost income,
disability, and health care costs is as much as $29 billion annually.
The consequences of medical mistakes are often more severe than
the consequences of mistakes in other industriesleading to
death or disability rather than inconvenience on the part of consumersunderscoring
the need for aggressive action in this area.
A wide body
of research, including many studies funded by AHRQ, supports the
IOM conclusions. The two seminal studies on medical error (Brennan,
1991; Thomas, 1999) have shown
that adverse events occur to approximately 3–4 percent of patients.
In another study (Leape, 1994),
the average intensive care unit (ICU) patient experienced almost
two errors per day. This translates to a level of proficiency of
approximately 99 percent. One out of five of these errors were potentially
serious or fatal. If performance levels of 99.9 percentsubstantially
better than those found in the ICUapplied to the airline and
banking industries, it would equate to two dangerous landings per
day at O'Hare International Airport and 32,000 checks deducted from
the wrong account per hour (Leape,
1994).
Many of these
adverse events are associated with the use of pharmaceuticals, and
are potentially preventable. The IOM estimates the number of lives
lost to preventable medication errors alone represents over 7,000
deaths annuallymore than the number of Americans injured in
the workplace each year. In addition, preventable medication errors
are estimated to increase hospital costs by about $2 billion nationwide.
A 1995 study estimated that problems related to the use of pharmaceutical
drugs account for nearly 10 percent of all hospital admissions,
and significantly contribute to increased morbidity and mortality
in the United States (Bates, 1995).
A 1991 study of hospitals in New York State indicated that drug
complications represent 19 percent of all adverse events, and that
45 percent of these adverse events were caused by medical errors.
In this study, 30 percent of the individuals with drug-related injuries
died (Leape, 1991).
The Clinton-Gore
Administration’s Commitment to Improving Patient Safety
In early 1997,
the President established the Advisory Commission on Consumer Protection
and Quality in the Health Care Industry (Quality Commission) and
appointed Health and Human Services Secretary Shalala and Labor
Secretary Herman as co-chairs. The Quality Commission released two
seminal reports focusing on patient protections and quality improvement.
Subsequent to the Commission’s second report on patient safety and
quality improvement and consistent with its recommendations, the
President established the Quality Interagency Coordination Task
Force (QuIC), a umbrella organization also co-chaired by Secretary
Shalala and Secretary Herman, to coordinate Administration efforts
to improve quality. As he established the QuIC, the President stated
that "For all of its strengths, our health care system still
is plagued by avoidable errors."
Also consistent
with the Quality Commission’s recommendations, Vice President Gore
launched the National Forum for Health Care Quality Measurement
and Reporting. Known as the Quality Forum, it is a broad-based,
widely representative private body that establishes standard quality
measurement tools to help all purchasers, providers, and consumers
of health care better evaluate and ensure the delivery of quality
services. In addition to the work and significant potential of the
QuIC and Quality Forum, other Federal agencies have made significant
efforts to reduce medical errors and increase attention on patient
safety.
In accordance
with its recent reauthorization, the AHRQ is the lead agency for
the Federal government on quality in health care. It sponsors research
examining the frequency and cause of medical errors and tests techniques
designed to reduce these mistakes. It also examines issues generally
related to health care quality, including overuse and underuse of
services.
The Department
of Defense (DoD) and the Department of Veterans Affairs (VA), serving
over 11 million patients nationwide, have begun to implement computerized
physician order entry systems, proven effective in reducing medical
errors. In addition, Veterans Affairs has implemented a computerized
medical record in all their 172 hospitals, making it possible to
reduce errors by providing complete information about patients at
the point of care. Over the past 3 years, the VA created an error
reporting system, established four Centers of Inquiry for Patient
Safety, and began to use barcode technology to reduce medication
errors.
The Health Care
Financing Administration (HCFA), through its Peer Review Organizations
(PROs), is working to reduce errors of omission for the 39 million
Medicare beneficiaries. Under their current performance-based contracts,
the PROs are working to prevent failures and delays in delivering
services for breast cancer, diabetes, heart attack, heart failure,
pneumonia, and stroke. These efforts have already decreased mortality
for heart attack victims.
The Centers
for Disease Control and Prevention (CDC) and the Food and Drug Administration
(FDA) collect data on adverse events that are the result of treatment,
such as hospital-acquired infections and the unintended effects
of drugs and medical devices. CDC's National Nosocomial Infections
Surveillance (NNIS) system is a hospital-based reporting system
that monitors hospital-acquired infections that afflict more than
two million patients every year. Among participating hospitals,
bloodstream infection rates have decreased by more than 30 percent
since 1990, and wound infections following surgery have decreased
by 60 percent among high-risk patients. FDA receives approximately
100,000 reports per year of adverse events associated with medical
devices and over 250,000 reports associated with pharmaceuticals.
FDA estimates that over one-third of the adverse events associated
with medical devices and pharmaceuticals are preventable.
In all of these
efforts, the Administration has worked closely with the private
sector and the States. Many States and members of the private sector
are moving ahead with actions to reduce the number of medical errors.
Currently, almost 20 States have implemented mandatory reporting
systems to improve patient safety and hold health care organizations
responsible for the quality of care they provide. The private sector
has also taken large strides to address the issue of patient safety,
most recently with the creation of the Leapfrog Group by executives
of some of the Nation’s biggest companies, including General Motors
and General Electric. This group encourages all employers to make
safe medicine a top priority of the health insurance they provide
and to steer workers to the hospitals that make the fewest mistakes.
While both the
public and private sectors have made notable contributions to reducing
preventable medical errors, additional and aggressive efforts are
needed in and outside of the Federal government to further reduce
these mistakes.
Institute
of Medicine Recommendations
The IOM report
recommends the establishment of a national goal of reducing the
number of medical errors by 50 percent over 5 years. To that end,
it outlined a four-tiered approach to reduce medical mistakes nationwide,
including actions to:
- Establish
a national focus to create leadership, research, tools, and protocols
to enhance the knowledge base about safety.
- Identify
and learn from medical errors through both mandatory and voluntary
reporting systems.
- Raise standards
and expectations for improvements in safety through the actions
of oversight organizations, group purchasers, and professional
groups.
- Implement
safe practices at the delivery level.
A Road Map
for Action: The Federal Response
The QuIC agencies
join the IOM’s call for action to reduce errors, implement a system
of public accountability, develop a robust knowledge base about
medical errors, and change the culture in health care organizations
to promote the recognition of errors and improvement in patient
safety. This report describes the actions that the QuIC agencies
will take to build on current programs and develop new initiatives
to reduce errors.
The QuIC fully
endorses the IOM’s goal of reducing the number of medical mistakes
by 50 percent over 5 years and has developed a strategy that builds
on the IOM recommendations and, in some cases, goes beyond them.
This strategy is detailed below.
Creating
a National Focus to Enhance the Knowledge Base on Patient Safety
IOM Recommendation:
Creating a Center for Patient Safety. The IOM recommends that
Congress fund a Center for Patient Safety within the Agency for
Healthcare Research and Quality (AHRQ) that will set national goals
for patient safety, track progress in meeting these goals, and issue
an annual report to the President and Congress on patient safety.
The Center should also enhance the current knowledge base on patient
safety by developing a research agenda, disseminating grants for
research on patient safety, funding Centers of Excellence, evaluating
methods for identifying and preventing errors, and funding dissemination
and communication activities to improve patient safety.
QuIC Response.
The Administration endorses the IOM recommendation and the President
has included $20 million in the Fiscal Year (FY) 2001 budget to
support a Center for Quality Improvement and Patient Safety at the
AHRQ, as part of the Agency’s broader quality agenda. The Center
will fund research on medical errors, principally through extramural
grants and contracts. It will work with private-sector entities
and public sector partners, including the Quality Forum, to develop
national goals for patient safety; issue an annual report on the
state of patient safety nationally; promote the translation of research
findings into improved practices and policies; and educate patients,
consumers, and health care providers about patient safety.
IOM Recommendation:
Establishing reporting systems nationwide. The IOM recommends
that the Administration and the Congress move to establish a nationwide
system of error reporting that includes both mandatory and voluntary
components.
Mandatory
Reporting Systems. The IOM recommends the development of a nationwide
mandatory reporting system to provide for the collection of standardized
information by state governments about adverse events that result
in death or serious harm. The report states that adverse event reporting
should initially be required of hospitals and eventually be required
of other institutional and ambulatory care delivery systems. It
recommends that this system should be implemented nationwide, linked
to systems of accountability, and made available to the public.
The IOM concludes that if States choose not to implement the mandatory
reporting system, the Department of Health and Human Services (DHHS)
should serve as the responsible entity.
Voluntary
Reporting Systems. The IOM report does not propose the establishment
of a national voluntary reporting system; rather, it offers a variety
of options for more limited voluntary reporting systems that function
in all 50 States and build on currently existing options, including
the development of systems focused on selected areas, such as medications,
surgery, and pediatrics or using a sampling technique to collect
the full range of information from a limited subset of health care
providers. The IOM recommends that more research be conducted to
determine the best way to develop voluntary reporting systems that
complement proposed mandatory reporting systems and can identify
potential precursors to errors, thus preventing patient harm. It
also recommends that the Congress extend peer review protections
to data related to patient safety and quality improvement collected
through voluntary reporting systems.
QuIC response.
The Administration agrees with the IOM that error reporting systems
should be established in all 50 States, and that these systems should
have both mandatory and voluntary components. Such an effort should
establish important complementary approaches to both learning and
accountability on errors. Well-designed patient safety programs
include reporting systems that both hold health systems accountable
for delivering high quality health care and provide important information
to health care decision-makers that improves patient safety.
The QuIC agrees
with the IOM that individuals should have access to information
leading up to and including the occurrence of a preventable error
that caused their serious injury or the death of a family member.
However, we believe that subsequent "root-cause" analyses
undertaken to determine the internal shortcomings of the hospital’s
delivery system should not be subject to discovery in litigation
and that appropriate legislation should be enacted in conjunction
with or prior to the implementation of mandatory or voluntary reporting
systems.
It is important
to note that the QuIC believes that any legislation or administrative
intervention in this area should not undermine individuals’ rights
to redress for criminal activity, malpractice, or negligence. The
QuIC does not support legislation that would allow safety reporting
systems to serve as a shield for providers engaging in illegal or
negligent behavior.
Mandatory
Reporting Systems. The QuIC supports the development of State-based
systems to require the collection of standardized information on
preventable, adverse events that result in death or serious harm,
and believes that the development of these systems are ultimately
in the best interests of patients. We agree with the IOM that the
scope of events targeted by mandatory reporting systems that contain
public disclosure components should be limited to serious, preventable,
and identifiable adverse events. By limiting required reporting
systems to the most serious of errorsthose causing life-long
disability or deaththis approach will most effectively target
egregious problems and minimize the cost of operating such a system.
The QuIC believes that, once mandatory systems are fully implemented,
such information for each health system should be consolidated and
made public, but that there should be no identification of patients
or individual health care professionals. The QuIC believes that
mandatory reporting systems that contain public disclosure components
should not be used as a tool for punitive action by State and local
authorities, but should be used as a mechanism to provide the public
with information about the safety of its health systems and to highlight
errors that can and should be prevented.
The IOM has
a set of specific recommendations for the structure of a nationwide
mandatory reporting system. The QuIC believes that there are a number
of issues that need to be addressed prior to determining the best
mechanism to ensure the establishment of State-based mandatory reporting
systems. The Administration will work with the Congress to outline
the appropriate Federal role in such a system. However, while these
issues are being resolved, the Administration will take the following
actions to demonstrate the importance of implementing mandatory
reporting systems and to create an environment in which there is
more widespread support for their use.
- Implement
a mandatory reporting system in the over 500 hospitals and clinics
operated by the Department of Defense. Beginning this spring,
the Department of Defense will implement a new reporting system
in its 500 hospitals and clinics serving approximately 8 million
patients. This confidential reporting system will be modeled on
the system in operation at the Department of Veterans Affairs
and will be used to provide health care professionals and facilities
with the information necessary to protect patient safety. This
system will begin to be pilot tested in August of 2000, will collect
information on adverse events, medication errors, close calls,
and other patient safety issues. DoD providers will inform affected
patients or their families when serious medical errors occur.
- Expand
mandatory reporting requirements for blood banks and establishments
that deal with blood products nationwide. By the end of the
year, the Food and Drug Administration (FDA) will release regulations
to improve the safety of blood transfusions by requiring the over
3,000 blood banks and establishments dealing with blood products
to report errors and accidents, such as mistyping blood products
and adverse events affecting donors, that affect patient safety.
Currently, only 400 blood banks are required to report such errors.
In addition
to Federal action to integrate mandatory reporting systems into
Federal agencies delivering care and strengthen the mandatory systems
that currently exist, there is a critical need for Federal leadership
in the development of patient safety standards. To that end, the
Federal government will:
- Identify
a set of patient safety measurements critical to the identification
of medical errors. The QuIC will ask the Quality Forum to
identify a set of patient safety measurements that should be a
basic component of any medical errors reporting system. Developing
standardized measures lays the foundation for a uniform system
of data collection and facilitates the development of these systems.
- Identify
a set of patient safety practices critical to prevention of medical
errors. The QuIC will ask the Quality Forum to identify, within
12 months, patient safety practices that should be adopted by
all hospitals and health systems, and will undertake activities
to encourage their widespread use. The QuIC suggests that mandatory
reporting systems include information on whether hospitals and
health systems' adopt these patient safety practices.
- Identify
issues related to the implementation of mandatory reporting for
error reduction. Using the Quality Forum’s recommendations
for medical error reporting, HCFA will develop a pilot project,
through the PRO program, for up to 100 hospitals that volunteer
to implement penalty-free, confidential, mandatory reporting systems.
These pilot projects will assist hospitals in changing their medical
delivery systems to reduce or eliminate errors. This pilot project
will include a rigorous evaluation component and identify issues
related to the implementation of medical error reporting systems.
- Determine
the most effective way to present information on the incidence
of medical errors to the public. HCFA, OPM, and AHRQ will
lead a QuIC effort to work with the Quality Forum and States that
have mandatory reporting systems to determine how data on medical
errors can be collected, validated, and presented to the general
public and local policy officialsand to determine the impact
of providing such information. Since informing the public about
the safety of their health care systems is a critical component
of mandatory reporting systems, this pilot project will provide
insights on presenting this information to the public.
- Examine
existing mandatory reporting systems. The Center for Quality
Improvement and Patient Safety, in collaboration with other QuIC
agencies, will evaluate the effectiveness of currently existing
mandatory reporting systems at the Federal and State levels and
develop recommendations to improve them. This information will
be presented to States and other organizations considering developing
such systems or that currently have existing systems, to help
them design effective reporting systems likely to improve patient
safety.
The QuIC believes
that these actions will encourage States to begin implementing their
own mandatory reporting systems for preventable adverse events,
with the goal that all 50 States have mandatory reporting systems
for preventable adverse events within 3 years. This time frame will
enable the Federal government, working with the Congress and other
private-sector stakeholders, to conclusively resolve outstanding
implementation issues. If all states have not implemented mandatory
reporting systems within three years, the QuIC will deliver recommendations
to the President that assure all health care institutions are reporting
serious, preventable adverse events.
Although currently
the QuIC believes that moving towards a mandatory reporting system
is the appropriate course of action, if research conducted by AHRQ
and other agencies indicates that the implementation of these systems
does not enhance (or detracts from) patient safety, these results
will be reported to the QuIC. Special emphasis will be placed on
efforts to determine whether making information public serves to
hold health systems accountable and reduce preventable errors, or
whether it only stifles reporting.
Voluntary
Reporting Systems. The QuIC agrees with the IOM that voluntary
reporting systems are a critical component of a national strategy
to reduce errors. Information from voluntary reporting systems is
usually gathered by an independent entity and is used to identify
patterns of errors. The QuIC proposes to integrate existing Federal
voluntary reporting systems with data collection efforts by States
and private organizations. The QuIC agrees with the IOM that these
programs should be confidential to protect the privacy of patients,
institutions, and providers reporting errors and close calls. Experience
in other industries demonstrates that confidentiality encourages
reporting. In order to encourage the development of voluntary reporting
systems, the Administration will:
- Implement
a voluntary reporting system nationwide for veterans’ hospitals.
The VA currently operates a mandatory reporting system. By
the end of the year, the VA will implement a voluntary reporting
system for both adverse events and close calls nationwide. Information
will be collected by an independent external entity, analyzed,
and disseminated to all VA health care networks to help prevent
medical errors. Implementing this system is likely to lead to
a richer database of information, as incidents are reported on
a de-identified basis, and will allow researchers to compare the
effectiveness of identified systems to de-identified ones.
- Examine
existing voluntary systems. The Center for Quality Improvement
and Patient Safety, with its QuIC partners, will evaluate the
effectiveness of existing voluntary reporting systems at the Federal
and State levels and develop recommendations to improve them.
This study will demonstrate which entity or entities would be
best to collect, analyze, and disseminate information on frequently
occurring errors and the best interventions to prevent them.
Setting Performance
Standards and Expectations for Safety
IOM Recommendation:
Include patient safety in performance standards and expectation
for health care organizations. The IOM recommends that regulators
and accreditors should require health care organizations to implement
meaningful patient safety programs with defined executive responsibility.
Public and private purchasers should provide incentives to health
care organizations to demonstrate continuous improvement in patient
safety.
QuIC response.
The QuIC reviewed current Federal activities and proposed several
ways to improve safety through current oversight activities. These
include:
- Assuring
that all hospitals participating in the Medicare program implement
patient safety programs. The Health Care Financing Administration
intends to publish regulations this year requiring the over 6000
hospitals participating in the Medicare program to have ongoing
medical error reduction programs that would include, among other
interventions, mechanisms to reduce medication errors. To comply
with this new regulation, most hospitals are likely to implement
systems such as automated pharmacy order-entry systems and automatic
safeguards against harmful drug interactions and other adverse
events.
- Requiring
the almost 300 health plans in the Federal Employees Health Benefits
Program to implement patient safety programs. In its annual
call letter, to be issued this April, the Office of Personnel
Management will announce that, beginning in 2001, all health plans
participating in the program will be required to implement patient
safety initiatives. OPM will encourage health plans to collaborate
with their providers to reduce errors and improve the quality
of care.
- Working
with private-sector employers and employees to incorporate patient
safety into purchasing decisions. This year, the Department
of Labor will include information on medical errors in the Health
Benefits Education Campaign. This national effort educates employees
about issues of quality and safety under their employer-provided
health benefits so that they can make informed health benefits
decisions and educates employers in order to facilitate the provision
of high-quality, affordable health benefits to their employees.
IOM Recommendation:
Performance standards and expectations for health professionals
should focus greater attention on patient safety. Periodic re-examination
and re-licensing of doctors, nurses, and other key providers should
be conducted based on both competence and knowledge of safety practices.
Professional societies should make a visible commitment to patient
safety by establishing a permanent committee dedicated to safety
improvement.
QuIC response.
The QuIC is supportive of these goals, but recognizes and agrees
with the IOM that they appropriately fall under State jurisdiction
and oversight. However, the QuIC agencies will provide technical
assistance to State or professional agencies seeking to ensure a
basic level of knowledge for health care providers on patient safety
issues, promote model patient safety programs that include evidence-based
best patient safety practices to provider organizations, or help
agencies encourage the cultural change necessary to make reporting
systems a success.
IOM Recommendation:
FDA should increase attention to the safe use of drugs. Both
pre- and postmarketing processes should be improved to maximize
safe drug use. FDA should develop and enforce standards for the
design of drug packaging and labeling that will maximize safety
in use and require pharmaceutical companies to test proposed drug
names to identify potential sources of confusion with existing drug
names. In addition, the Agency should work with physicians, pharmacists,
consumers, and others to establish appropriate responses to problems
identified through post-marketing surveillance activities.
QuIC response.
The QuIC endorses the IOM recommendation. FDA currently has
a strong program of pre- and post-market surveillance, and is pleased
that the President is committing $33 million, an increase of 65
percent over last year’s funding level, in his FY 2001 budget to
prevent medical errors associated with drugs and medical devices.
Among other things, it would:
Initiate
new efforts to ensure that pharmaceuticals are packaged and marketed
in a manner that promotes patient safety. Within one year, FDA
will develop new standards to help prevent medical errors caused
by proprietary drug names that sound similar or packaging that looks
similar, making it easy for health care providers to confuse medications.
The Agency will also develop new label standards by the end of the
year that highlight common drug-drug interactions and dosage errors
related to medications.
Implementing
Safety Systems in Health Care Organizations
IOM Recommendation:
Health care organizations should make continually improved patient
safety a declared and serious aim. Patient safety programs
should provide strong, clear, and visible attention to safety; implement
non-punitive systems for reporting and analyzing errors within their
organizations; and incorporate well-understood safety principles.
QuIC response.
The QuIC supports this recommendation, and Federal agencies
will take the following actions:
The Department
of Veterans Affairs. The VA is considered one of the Nation’s
leaders in patient safety, having instituted patient safety programs
in all of its health care facilities serving 3.8 million patients
nationwide. This year, the VA will invest over $47.6 million to
increase the requirement for patient safety training for staff from
15 to 20 hours a year, provide "VA Quality Scholars" fellowships
for 10 physicians, implement a patient safety awards program, and
place "patient safety checklists" in operating rooms in
every hospital nationwide.
The Department
of Defense. Beginning this fall, the Department of Defense will
invest $64 million in FY 2001 to begin the implementation of a new
computerized medical record, including an automated entry order
system for pharmaceuticals, that makes all relevant clinical information
on a patient available when and where it is needed. It will be phased
in at all DoD facilities over 3 years.
The QuIC
Task Force. This summer, the QuIC member agencies, including
DoD, VA, AHRQ, and HCFA, will begin a collaborative project with
the QuIC Task Force and the Institute for Healthcare Improvement
to reduce errors in "high hazard areas," such as emergency
rooms, operating rooms, intensive care units, and labor and delivery
units.
IOM Recommendation:
Improve medication safety. Health care organizations should
implement proven medication safety practices.
QuIC Response.
The QuIC endorses this recommendation. This year, VA will invest
$75.1 million to complete the implementation of an automated order
entry system in all of its health care facilities, along with a
barcoding system for blood transfusions and medication administration.
A 1999 evaluation of this system indicates that it has reduced medication
errors by 67 percent since its implementation. The Department of
Defense will invest $12 million to implement an integrated pharmacy
system that creates a single profile for all the medications a patient
takes, regardless of whether the prescriptions were filled at military
and private pharmacies serving DoD beneficiaries worldwide by the
end of 2000.
In addition,
to comply with the new proposed requirement that hospitals participating
in the Medicare program have error reduction programs, hospitals
are likely to implement programs such as automated pharmacy order-entry
systems. Furthermore, as highlighted in the prescription drug provisions
in the President’s Medicare reform initiative, any outpatient drug
benefit for Medicare beneficiaries should require private contractors
administering the program to use the latest patient safety techniques,
including drug utilization review and patient counseling.
Additional
Federal Actions to Improve Patient Safety
The President
asked the QuIC to identify additional strategies to reduce medical
errors and ensure patient safety in Federal health care programs.
This report includes several additional recommendations, including
an emphasis on the application of information systems and computer-based
initiatives to improve patient safety. The President has requested
$20 million in his FY 2001 budget to develop a consistent structure
for health care information technology that incorporates strong
privacy protections for patients and providers. Investments in information
technology are one of the most effective and efficient ways to improve
the quality of health care. This Health Informatics Initiative will
address the problem of medical errors as a part of the Administration's
efforts to improve health care quality through enhanced information
technology.
Conclusion
In this report,
the QuIC proposes to take strong action on each and every one of
the IOM recommendations to promote safer health care. While some
of the IOM’s recommendations can be addressed individually by specific
agencies, the majority of the proposed actions require joint effort.
The QuIC and its participating agencies are eager to partner with
a broad array of public, state, and private organizations in a national
effort to reduce medical errors and improve patient safety.
National
Focus and Leadership
Center for
Patient Safety
- AHRQ will
take immediate action to establish the Center for Quality Improvement
and Patient Safety (CQuIPS), which will replace and broaden the
mission of AHRQ’s Center for Quality Measurement and Improvement.
- CQuIPS will
coordinate with and complement other public- and private-sector
initiatives to improve patient safety.
- QuIC will
coordinate Federal activities on patient safety, as it does on
the broader quality agenda. This will include both regular meetings
of the QuIC and use of its current structure to redirect QuIC
working group efforts towards enhancing patient safety.
- AHRQ will
sponsor a program to educate personnel of QuIC member agencies
about patient safety, bringing them together with leading researchers
on human factors analysis, systems design, error reporting, and
quality improvement. This curriculum will serve as a model and
be expanded for future educational activities with private-sector
partners.
- QuIC agencies
such as OPM, HCFA, DoD, and VA will demonstrate their national
leadership as purchasers and providers of care, developing model
programs that use information on errors to improve patient safety.
- Federal agencies
and other bodies, including AHRQ, FDA, CDC, and HCFA, will collaborate
to provide national leadership in developing and testing systems
of mandatory reporting for public accountability.
Research
Planning
- Hold national
summits on medical error and patient safety research: AHRQ will
lead the convening of conferences and expert meetings to review
the information needs of those who wish to improve safety, assess
the current state of patient safety research, set coordinated
research agendas, and develop adequate reporting mechanisms. VA
will lead a summit on lessons learned from its experiences in
improving patient safety, and the FDA will lead a summit on drug
errors. These summits will take place within 1 year.
- Establish
joint research solicitations (including partnerships between AHRQ,
CDC, FDA, and VA) for:
Fundamental Research on Errors: Investigate root causes
analysis, informatics, the role(s) of human factors, and legal/judicial
issues.
Research on Reporting Systems: Identify critical components
of successful reporting systems used for learning, examine options
for voluntary and mandatory reporting systems, implement and evaluate
demonstration programs for reporting, evaluate existing State mandatory
reporting systems, and investigate techniques and methods for analyzing
and disseminating patient safety data (including integration into
a National Quality Report being prepared by DHHS under the leadership
of AHRQ and CDC).
Applied Research on Patient Safety: Test the application
of human factors knowledge to the design of health care products,
processes, and systems; identify best practices in reducing errors;
fund patient safety "Centers of Research Excellence";
and support research and demonstrations on-site, as well as level-of-care
and cross-cutting research, such as in diagnostic accuracy, informatics
applications, and systems re-engineering.
- Develop tools
for the public and private sector to support efforts to enhance
patient safety, including:
Applications:
Identify tools and approaches from other industries that could be
applied to the health care sector and develop community-based settings
that can serve as laboratories for error reduction through medical
specialty societies, primary care networks, and integrated service
delivery networks.
Measures: Develop and evaluate data specifications
for reporting on patient safety and work with the Quality Forum
and other private- and public-sector efforts on developing consensus
around a core set of measures for patient safety.
- Finalize
a QuIC Research Agenda on Working Conditions and Patient Safety.
The QuIC will finalize a research agenda to explore the relationship
between health care workers’ working conditions and the quality
of patient care, including patient safety. CDC and AHRQ will coordinate
this activity with VA and other agencies.
Identifying
and Learning From Errors
Accountability
- The QuIC
will ask the Quality Forum to define unambiguously, within 12
months, a set of egregious errors that are preventable and should
never occur. These measures will serve as criteria for a HCFA-sponsored
mandatory reporting demonstration project with a State that already
has an existing mandatory reporting requirement. HCFA will publish
the hospital rates for these events without patient identifiers.
- HCFA and
its QuIC partners will evaluate whether consumers found this information
valuable and what they understood about it. Based on these results,
HCFA will move towards a national mandatory reporting system,
with publication of findings, for all hospitals participating
in Medicare.
- Federal agencies,
in partnership with other organizations, will develop options
for mandatory reporting systems that provide the public and purchasers
with publicly available information about programs and procedures
in place to reduce errors. This work will require the development
of evidence-based, systems-level measures in collaboration with
the Quality Forum.
- OPM will
require that health plans have error reduction plans and will
report on its web site whether the health plans have reliable
patient safety initiatives in place.
- QuIC will
ask the Quality Forum to identify, within 12 months, patient safety
practices that institutions should undertake and urges that information
about whether the measures are in place be made available to the
public.
- FDA will
report to the public on the safety of drugs, devices, and biologic
products.
- QuIC proposes
that State and Federal mandatory reporting systems, as well as
those of private accrediting and other oversight groups, be evaluated
to determine the ways in which they are helpful in assuring public
accountability for patient safety, and that these results be used
to develop future reporting systems.
- AHRQ will
include information on patient safety in the National Quality
Report it is developing in collaboration with other agencies,
in particular, the National Center for Health Statistics.
- OPM will
require that health plans describe their patient safety initiatives,
will make patient safety information available in both print and
electronic formats for the open enrollment period in Fall, 2000,
and will expand its Web site to include information about programs
designed to reduce errors and enhance patient safety.
- OPM will
encourage health plans to annotate Preferred Provider Organization
(PPO) directories to indicate which hospitals and physicians’
offices use automated information systems.
- FDA will
improve the safety of transfusions by expanding mandatory reporting
requirements for blood bank errors and accidents, so that they
apply to all registered blood establishments.
Learning
from Errors
- The new Center
for Quality Improvement and Patient Safety (CQuIPS) at AHRQ will
identify existing State and Federal reporting systems (both mandatory
and voluntary), evaluate their suitability in helping to build
a national system of errors reporting, and evaluate how their
data collection or enforcement efforts can be enhanced to improve
the value of those systems.
- QuIC will
work with the Quality Forum to develop reporting criteria that
assure that information can be pooled and shared as needed across
organizations.
- CQuIPS, working
with the QuIC, will describe and disseminate information on characteristics
of existing voluntary reporting programs associated with successful
error reduction and patient safety improvement efforts. FDA, CDC,
and NASA will provide expertise in the development of these nonpunitive
systems.
- Within six
months, HCFA, working with a Peer Review Organization (PRO) program,
will develop a pilot of a confidential, penalty-free learning
system with several hospitals on a voluntary basis.
- Federal agencies,
including the FDA, VA, DoD, CDC, HCFA, and AHRQ, will integrate
data from different sources and conduct and support analysis to
identify error prone procedures, products, and systems.
- By August
2000, the DoD will complete development of a patient safety improvement
program based on a reporting system modeled on that of the VA.
- VA will establish
a voluntary reporting system to supplement its existing mandatory
system.
- AHRQ, in
collaboration with other Federal agencies, will investigate, develop
and test strategies to provide effective feedback to clinicians
and institutions on methods for improving patient safety.
- Federal agencies
will assist health care providers to develop the skills necessary
for analyzing adverse events and near misses (e.g., root cause
analysis, trending, search tools). Federal agencies providing
health care will develop internal systems to 1) identify and report
errors to clinicians and other decision makers, and 2) learn from
those errors and near misses to prevent future events.
- Outreach
to Stakeholders: QuIC will develop programs to foster the dissemination
of research findings to end users through activities such as AHRQ’s
User Liaison Program; provide support to the Quality Forum to
increase the national discussion on errors, their reduction, and
standardized measures of errors; and fund collaborative agreements
with health care professional organizations that foster education,
track patient safety initiatives, provide input to the new patient
safety research centers, and translate, disseminate, and promote
adoption of research findings.
- Patient Safety
Clearinghouse: AHRQ will develop a clearinghouse in partnership
with other Federal agencies and private-sector organizations to
provide an objective source of state-of-the art information on
patient safety.
- AHRQ will
initiate a "National Morbidity & Mortality Conference"
posting selected cases (stripped of identifying information) in
a public forum via Internet technology, and establish a Web site
where patients can report incidents that will be analyzed to identify
emerging problems.
Peer Review
Protections
- The QuIC
supports the extension of peer review protections to facilitate
reporting of errors in a blame-free environment, and will propose
considerations of confidentiality that will not undermine current
mechanisms to address criminal activity or negligence.
- As part the
development of the national reporting system, appropriate electronic
protections (i.e., firewalls and encryption) will be constructed
to ensure that the confidentiality of the patients involved and
the clinician or institution providing the information is maintained,
and that the information gathered will not be used for punitive
purposes. Experience with reporting systems in other industries
demonstrates that this approach encourages reporting of errors.
Setting
Performance Standards and Expectations for Safety
Raising the
Standards for Health Care Organizations
- HCFA will
use its power as a purchaser and regulator to promote the use
of effective error-reduction initiatives in the health care institutions
with which it deals.
- HCFA will
publish regulations this year requiring hospitals participating
in the Medicare Program to ongoing medical error reduction programs.
- OPM will
follow the lead of selected private purchasers to raise the standard
for participation by requiring that all health plans with which
it contracts seek accreditation from an independent, national
accrediting organization that includes evaluation of patient safety
and programs to reduce errors in health care.
- In its call
letter for the 2001 contract year, OPM will ask health plans to
encourage their preferred hospitals to use automated prescription
systems and other integrated data systems. OPM will encourage
health plans to annotate PPO directories to indicate which hospitals
and physicians’ offices use such automated programs.
Raising the
Standards for Health Care Professionals
The QuIC will:
- Develop and
evaluate programs introducing health professionals to errors analysis
and the challenges of practicing in a technically complex environment,
explore the use and testing of simulators and automation as education
tools, support training in errors research and evaluation, and
develop patient safety expertise at the State level using the
CDC’s Epidemic Intelligence Service as a model.
- Convene a
meeting of the accrediting, licensing, and certifying bodies of
the health professions to review information on medical errors
in the context of current practice requirements and propose methods
of strengthening health professions’ education in the areas of
medical error prevention and medical error evaluation as a means
of improving patient safety.
- Collaborate
with the Federation of State Medical Boards and other entities
to encourage that error reduction and prevention education be
a provision for relicensing of health professionals.
- Collaborate
in the planning, implementation, and evaluation of a national
summit addressing patient safety and medical error reduction programs,
and in producing directives for the future.
- Provide training
within the QuIC agencies that provide care to encourage use of
patient safety information and encourage enhanced reporting in
partnership with private-sector accreditors, purchasers, and providers.
- Provide technical
assistance to State or professional agencies seeking to ensure
a basic level of knowledge for health care providers on patient
safety issues.
Safe Use
of Drugs and Devices
Within 1 year,
the FDA will initiate programs to:
- Develop additional
standards for proprietary drug names to avoid name confusion.
- Develop standards
for packaging to prevent dosing and drug mix-ups.
- Develop new
label standards for drugs, highlight drug–drug interactions, potential
dosing errors, and address other common errors related to medications.
- Implement
the Phase II pilot study of the Congressionally mandated Medical
Product Surveillance Network (MedSUN).
- Intensify
efforts to ensure manufacturers’ compliance with FDA programs,
specifically naming, labeling, and packaging.
- Provide access
to databases linked to health care systems and other sources of
adverse-event and marketing data, and link these to existing registries
of product users.
- Complete
the on-line Adverse Event Reporting Systems (AERS) for drugs and
biologics.
- Strengthen
FDA's analytical and investigative capacities.
- Strengthen
FDA outreach activities and collaboration with other Government
agencies and stakeholders.
Implementing
Safety Systems in Health Care Organizations
- Under the
leadership of the CQuIPS, the QuIC will promote, at the executive
level, the development and dissemination of evidence-based, best
patient-safety practices to provider organizations.
- QuIC participants,
including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities
with private-sector accreditation, purchaser, and provider organizations
to develop organization-based, patient-safety models that could
be evaluated, and if found effective, disseminated widely. In
addition, these stakeholders will be engaged in a regular dialogue
with QuIC participants to ensure that the stakeholders’organizational
needs are being met through Federal research and reporting initiatives.
- Through its
exemplary patient safety program, VA will continue to scrutinize
its care provision for opportunities to improve safety, and develop
and expand its reporting system.
- VA will invest
$47.6 million this year to increase patient safety training for
staff (select for details in Chapter
3).
- DoD will
invest $64 million in FY 2001 to begin implementation of a new
computerized medical record system, including an automated order
entry system for pharmaceuticals (details in Chapter
3).
- Other QuIC
direct-care providers will initiate patient safety programs (e.g.,
HRSA’s community health care centers are investigating the most
effective programs that can be implemented in their health care
delivery systems).
- QuIC member
agencies will begin a collaborative project this summer with the
Institute for Healthcare Improvement to reduce errors in high-hazard
health care delivery settings.
Building
Public Awareness of Medical Errors
- Through the
QuIC’s Enhancing Patient and Consumer Information Working Group,
led by OPM and HCFA, Federal agencies will develop and coordinate
an information campaign for their constituencies and beneficiaries
to increase their awareness of the problem of medical errors and
patient safety.
- AHRQ will
develop generic material for the public on preventing medical
errors that Federal agencies can disseminate, reprint, or adapt.
This material will enable patients to become more involved in
their care and to be more active participants in the decisionmaking
surrounding their care.
- The CQuIPS
will develop and test patient safety questions for inclusion in
the patient survey now being developed for provider-level assessment
of health care.
- HCFA will
conduct research aimed at shaping programs to educate beneficiaries
about medical errors.
- Within 1
year, FDA will increase collaborative programs with patient and
consumer groups regarding patient safety.
- FDA will
enhance its interactions with the public through meetings with
consumer and patient organizations, and through grass-roots informational
meetings. The meetings will focus on patient needs and the safe
use of medical products, particularly for home use. The meetings
will also discuss how to reach patients with important information
on safe use of medical productsincluding through the use
of local networks, the Internet, and electronic and print media.
This will occur within 1 year.
- Patient safety
and reducing medical errors will be a featured topic at OPM’s
Fall 2000 annual health plan conference.
Building
Purchasers’ Awareness of the Problem
- Building
on existing relationships with purchasers and business coalitions,
such as the National Business Coalition on Health, and the Washington
(DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM,
and AHRQ will spearhead the QuIC’s efforts to promote collaborative
programs with other public- and private-sector partners to increase
purchasers’ and providers’ awareness of medical errors as a health
care problem and of steps that each can take to address this problem,
such as addressing patients’ health literacy skills.
- At the Federal
Benefits Conference (June 2000), OPM will share information about
patient safety with representatives from Federal agencies throughout
the Nation.
Working with
Providers to Improve Patient Safety
- Through the
QuIC, Federal agencies will take advantage of existing resources
to promote collaborative patient safety programs involving agency
constituents, the health professions community, the public, academia,
and other stakeholders, such as the American Medical Association,
the American Nurses Association, NPSF, NPSP, and the Quality Forum.
- VA will develop
and run pilot patient safety education programs for medical residents
and students.
Using Decision-support
Systems and Information Technologies
- AHRQ and
CDC will expand research efforts in the area of informatics to
include initiatives aimed at developing and evaluating electronic
systems to identify, track, and address patient safety concerns.
- CQuIPS at
AHRQ, along with VA, DoD, FDA and other QuIC member agencies,
will evaluate the effectiveness of automated physician order entry
systems in hospitals.
- DoD, VA,
and IHS will introduce electronic patient records to offer structured
documentation and a common clinical lexicon for practitioners
working throughout those systems. The QuIC will encourage other
potential Federal participants to do likewise.
Using Standardized
Procedures, Checklists, and the Results of Human Factors Research
- CDC and FDA
will work with the DHHS Advisory Committee on Blood Safety and
Availability to help ensure that the highest quality standards
are met in blood collection and transfusion.
- Within 1
year, FDA will begin working with manufacturers of medical products
to explore incorporating standards, including human factors standards,
into guidance to ensure that medical products are designed to
minimize the chance of errors.
- NASA will
be invited to become a participant in QuIC activities and bring
its understanding and experience in redesigning processes and
procedures to enhance safety. Linkages between NASA and the CQuIPS
will be established through the NASA Medical Policy Board.
- The QuIC
will sponsor an educational program, noted in the section on research
above, to increase the awareness of Federal regulators and policymakers
regarding patient safety, human factors, and systems-based improvement.
- VA will continue
to work with private-sector organizations (e. g., the American
Hospital Association and JCAHO) to explore the utility of its
comprehensive error analysis and corrective action system.
Standards
- The QuIC
and its member agencies will ask independent accrediting organizations
to demonstrate how they are coordinating and strengthening their
patient safety standards.
- AHRQ’s CQuIPS,
through the research agenda articulated above, will develop evidence-based
measures that integrate human factors and lessons from other industries.
- As with the
DQIP measurement set, the QuIC will solicit formal adoption and
use by member agencies of common, validated, and standardized
performance measures in the area of error reduction. The QuIC
will work with certifying boards for healthcare professionals
to incorporate these measures into certification and recertification
programs where appropriate.
- QuIC agencies
will encourage their private-sector partner organizations to support
the implementation of more rigorous safety standards and will
act to facilitate the ability of private-sector partners to do
so.
- The QuIC
will work through the Quality Forum, the NPSF, and the NPSP to
collaborate with private-sector organizations, industry representatives,
academic institutions, and scientific and health care professionals
to examine issues related to standards, to test standards of performance
measurement, and to establish a set of core standards.
- DOL will
build on an existing collaboration with the National Association
of Insurance Commissioners (NAIC) to exchange information between
DOL, the States, employers, plans, and individual patients on
medical errors and safe, high-quality health care.
- OPM will
participate with private-sector organizations in the development
of standards and measures, will share QuIC-adopted standards and
measures with its health plans, and advocate the use of such standards
and measures throughout plan networks.
- OPM will
also begin collecting performance measurement data from its participating
plans, and will make performance information available to beneficiaries
of the Federal Employees Health Benefits Program.
- Patient
safety and reducing medical errors will be a featured topic at
OPM’s Fall 2000 annual health plan conference.
Data Integration
- The QuIC
members will work with and support the Quality Forum in its identification
of a core set of errors reporting data.
- AHRQ, working
with its QuIC partners, will identify existing data sets (such
as the State mandatory errors reporting data) that can be brought
together to enhance the Nation’s knowledge and understanding of
errors. Based upon experience with the HCUP and the CDC’s data
integration efforts, AHRQ will work with those entities that have
the data, to determine the feasibility of pooling the data and
using this resource to learn about opportunities to reduce errors
and enhance patient safety.
- OPM will
discuss with health plans and preferred provider organizations
the development of strategies for focusing disease management
programs and integrated data systems on the goal of avoiding medical
errors and improving patient outcomes.
- HCFA, in
collaboration with FDA and AHRQ, will develop a strategy for incorporating
initiatives to increase patient safety into the pharmacy benefit
managers program under an expanded Medicare drug benefit.
Introduction.
Errors: Part of a Broader Quality Agenda
"Mistakes
are a fact of life. It's the response to the error that counts."
Nikki
Giovanni (American poet, 1943- )
For years, experts
have recognized that medical errors exist and compromise health
care quality, but the response to the November 30, 1999, release
of the Institute of Medicine’s (IOM) report, To Err is Human:
Building a Safer Health System, brought medical errors to the
forefront of public attention. The report’s estimate that 44,000
to 98,000 Americans die each year as a result of adverse events
has captured the public’s concern and resulted in a sense of urgency
about increased attention to safety in the health care system. On
December 7, 1999, one week after the IOM report’s release, the President
directed the Quality Interagency Coordination Task Force (QuIC)
to evaluate the recommendations in To Err is Human and report
to him through the Vice President within 60 days "with recommendations
to improve health care through the prevention of medical errors
and enhancements of patient safety."
The QuIC was
established by the President in the spring of 1998. Its goals are
to ensure that all Federal agencies involved in purchasing, providing,
studying, or regulating health care services are working in a coordinated
way toward the common goal of improving the quality of care; to
provide beneficiaries with information to assist them in making
choices about their care; and to develop the infrastructure needed
to improve the health care system, including knowledgeable and empowered
workers, well-designed systems of care, and useful information systems.
The participating
Federal agencies include the Departments of Health and Human Services,
Labor, Defense, Veterans Affairs, and Commerce; the Office of Personnel
Management, the Office of Management and Budget, the U.S. Coast
Guard, the Federal Bureau of Prisons, the National Highway Transportation
and Safety Administration, and the Federal Trade Commission. The
QuIC is co-chaired by Secretary of Health and Human Services Donna
Shalala and Secretary of Labor Alexis Herman. John Eisenberg, Director
of the Agency for Healthcare Research and Quality, serves as Operating
Chair of the QuIC.
The QuIC believes
that the IOM report has performed an important service in drawing
national attention to the problems of patient safety, showing how
preventable errors cause an immense burden for patients and the
Nation’s health care system. The Federal agencies that are members
of the QuIC are working actively to reduce this burden through their
roles as purchasers (i.e., buyers of health care services through
private insurers or health maintenance organizations), program funders,
research agencies, regulators, patient advocates, and providers
of care. Some of the QuIC participants are already recognized as
leaders in error recognition and prevention, and all are committed
to improving the health care that Americans receive.
The QuIC agencies
are aware of several challenges, many of which were dealt with in
the IOM report, that must be addressed if there is to be a substantial
increase in patient safety. This report addresses those issues,
recognizing that the improvement of patient safety will require
coordinated actions from a wide array of individuals and organizations
involved in health care, including public and private-sector purchasers,
providers, and oversight bodies, as well as patients. This report
discusses ways the Federal Government, in collaboration with its
partners in the private sector and in State and local government,
can uncover the root causes of errors, identify best practices to
avoid them, accelerate the widespread adoption of these best practices,
and ensure that the public can be assured that the health care delivery
systems on which their lives depend are operating safely.
The IOM emphasized
that errors should not be studied in isolation from other health
care issues. Rather, the IOM report To Err is Human is part
of a larger project on quality in health care that is investigating
ways to redesign the delivery system, realign financial incentives
to reward high quality care, and use information technology as a
tool for measuring and understanding quality. Because the QuIC also
has a broad quality mandate, member agencies are already working
in these areas and believe that progress in the broad domain of
health care quality is essential to the more specific but compelling
need to reduce errors.
The IOM
Report
In addition
to documenting the need for attention to the issue of patient safety,
the IOM report makes specific recommendations for actions to galvanize
the health care industry into action to improve safety. In brief,
the key recommendations of the IOM report include:
- Establish
a Center for Patient Safety at the Agency for Healthcare Research
and Quality (AHRQ). The IOM recommends that a center be established
within AHRQ with responsibility for promoting the development
of knowledge about errors and to encourage the sharing of strategies
for reducing errors. The IOM committee recommends substantial
budget increases over the next several years.
- Promote voluntary
and mandatory reporting of errors. First, the IOM recommends that
voluntary reporting systems should focus on errors that
result in little or no harm to patients, and should be encouraged
by AHRQ. Second, a mandatory reporting system should be
established to allow State governments to collect standardized
information on adverse events resulting in death or serious harm.
- Protect reporting
systems from being used in litigation. The IOM urges Congress
to pass legislation extending peer review protections to data
related to patient safety and quality improvement that are collected
and analyzed by health care organizations for purposes of improving
safety and quality.
- Make patient
safety the focus of performance standards for health care organizations
and professionals. Regulators and accreditors should require health
care organizations to have meaningful patient safety programs.
Purchasers are also encouraged to provide incentives for patient
safety programs. The IOM suggests that professional licensing
organizations periodically reexamine and relicense professionals
based, in part, on their knowledge of patient safety. Licensing
organizations also need to develop more effective means of identifying
unsafe practitioners and taking actions against them. It also
suggests that professional societies should promote patient safety
education.
- Increase
FDA attention to safety in pre- and postmarket reviews of drugs.
The IOM specifically suggests developing standards for safe packaging
and labeling; testing of drug names to prevent sound-alike and
look-alike errors; and working with doctors, pharmacists, and
patients to identify and rectify problems in the post-marketing
phase.
- Encourage
health care organizations to make a commitment to improving patient
safety and to implement safe medication practices. Health care
organizations should develop a culture of safety and implement
nonpunitive systems for reporting and analyzing errors. These
organizations should also follow recommendations for safe medication
practices as published by professional and collaborative organizations
interested in patient safety.
The President’s
Directive
In response
to the IOM report, the President directed the QuIC to prepare a
set of recommendations for specific actions to improve health care
outcomes and prevent medical errors. These recommendations were
to include specific actions in both the public and private sectors,
and be consistent with the strong privacy protections proposed by
the Administration. Specifically, the President requested that the
QuIC report:
- Identify
prevalent threats to patient safety and medical errors that can
be prevented through the use of decision-support systems, such
as patient monitoring and reminder systems.
- Evaluate
the feasibility and advisability of the recommendations provided
by the Institute of Medicine's Quality of Health Care in America
Committee on Patient Safety.
- Identify
additional strategies to reduce medical errors and ensure patient
safety in Federal health care programs.
- Evaluate
the extent to which medical errors are caused by misuse of medications
and medical devices, and consider steps to strengthen the Food
and Drug Administration's surveillance and response system to
reduce their incidence.
- Identify
opportunities for the Federal Government to take specific action
to improve patient safety and health care quality nationwide through
collaboration with the private sector, including through the National
Forum for Health Care Quality Measurement and Reporting (the Quality
Forum).
The President
requested that the recommended actions serve as a foundation for
a national system that prevents adverse medical events.
The QuIC has
prepared this response to the President’s directive with several
principles in mind. First, it agrees with the IOM and with private-sector
experts that medical errors are generally due to systemic flaws
in health care rather than individual incompetence or neglect. Bad
care givers are sometimes a problem, but most errors are the result
of weaknesses in the organization of the health care system and
its component services. Thus, the QuIC agrees with the IOM emphasis
on systemic solutions and avoidance of the assignment of blame.
Second, the
QuIC agrees with the IOM and other experts that errors are one of
a number of problems in the health care system that compromise patient
safety and quality and endanger large numbers of patients in ways
that can be avoided. These include under-treatment, excessive treatment,
and widespread deviations in practice that cannot be explained scientifically.
Third, the QuIC
shares the belief of many experts that errors can be reduced and
safety enhanced in health care by applying lessons from successful
efforts in other American industries to improve quality. Now is
the time to use these lessons in health care.
Fourth, the
QuIC recognizes that errors occur in all sectors of health care,
not just hospitals, and in all types of care, including prevention,
diagnosis, drug therapy, anesthesia, surgery, and others.
Fifth, the Nation’s
response to errors should emphasize opportunities to learn from
errors in order to avoid future errors. The QuIC believes that Government
can assist health care institutions to develop appropriate systems
for capturing such knowledge, which will require some degree of
confidentiality to operate effectively.
Sixth, Federal
and State governments have the responsibility to ensure, through
mandatory public reporting, that the Nation can determine whether
health care institutions have met an adequate standard of patient
safety. Public reporting of both certain types of errors and the
use of proven error-reduction techniques would provide the Nation
with information that is needed to make choices about where to seek
health care.
Finally, the
QuIC agrees with the IOM on the importance of launching patient
safety initiatives within the context of the roles of the Federal
Government in health care quality, as purchasers, program funders,
research agencies, regulators, patient advocates, and providers
of care.
This report
to the President focuses on the roles that the Federal Government
can and should play in the development and implementation of systemic
solutions for avoiding medical errors. The Federal Government, in
partnership with State and local governments and the private sector,
can lead the way toward reaching this goal.
The following
chapters describe the steps that QuIC’s member agencies are taking
to assure patient safety. These steps can serve as a framework for
developing a national strategy to reduce errors and variations in
health care practices so that Americans not only get the best health
care in the world, but the best health care possible.
Chapter
1. Understanding Medical Errors
Growing
Concerns About Medical Errors
The IOM’s release
of To Err is Human brought medical errors and patient safety
the attention it has long needed but never had. The information
presented in the report is not new. Indeed, many studies, some as
early as the 1960s, showed that patients were frequently injured
by the same medical care that was intended to help them (Schimmel,
1964). While evidence of medical error has existed for some
time, the report succeeded in capturing the public’s attention by
revealing the magnitude of this pervasive problem and presenting
it in a uniquely compelling fashion. The IOM estimates that medical
errors cause between 44,000 and 98,000 deaths annually in the United
States. Using the more conservative figure, medical errors rank
as the eighth leading cause of death, killing more Americans than
motor vehicle accidents, breast cancer, or AIDS. In addition to
this extraordinary human toll, medical errors result in annual costs
of $17 to $29 billion in the United States (Institute
of Medicine, 1999). Additionally, fear of becoming a victim
of medical error may lead patients to delay obtaining potentially
beneficial medical care, which may allow their illnesses to worsen.
Experiencing
harm as a result of receiving health care is a growing concern for
the American public. Front-page articles in newspapers, television
exposes, and cover stories in magazine have provided the stark details
of the latest and most dramatic examples of medical errors. Until
recently, the perception of medical errors among health care providers
and the public has been shaped by these anecdotes, and remedies
have focused on fixing blame on individual providers, including
health plans, hospitals, doctors, pharmacists, nurses, and other
caregivers. That approach, however, has proven ineffective in addressing
patient safety, as documented by the ongoing problems noted in the
IOM report. The IOM’s recommended alternative approaches and other
ways in which the Federal agencies can work to reduce medical errors
are described in this report.
Definitions
and Context
The lack of
standardized nomenclature and a universal taxonomy for medical errors
complicates the development of a response to the issues outlined
in the IOM report. A number of definitions have been applied to
medical errors and patient safety. In To Err is Human, the
IOM adopted the following definition:
An error
is defined as the failure of a planned action to be completed
as intended or the use of a wrong plan to achieve an aim.
In an effort
to thoroughly consider all of the relevant issues related to medical
errors, the QuIC expanded of the IOM definition, as follows:
An error
is defined as the failure of a planned action to be completed
as intended or the use of a wrong plan to achieve an aim. Errors
can include problems in practice, products, procedures, and systems.
The explicit
acknowledgment of the broad scope of errors reflected in this definition
respects the responsibilities and capabilities of the Government
agencies and departments contributing to this report. The term "patient
safety" as used here applies to initiatives designed to prevent
adverse outcomes from medical errors. The enhancement of patient
safety encompasses three complementary activities: preventing errors,
making errors visible, and mitigating the effects of errors.
It is critical
to recognize that not all bad outcomes for patients are due to medical
errors. Patients may not be cured of their disease or disability
despite the fact that they are provided the very best of care. Additionally,
not all adverse events that are the result of medical care are,
in fact, errors. An adverse event is defined broadly as an injury
that was caused by medical management and that resulted in measurable
disability (Leape, 1991). Some
adverse events, termed "unpreventable adverse events,"
result from a complication that cannot be prevented given the current
state of knowledge. Many drugs, even when used appropriately, have
a chance of side effects, such as nausea from an antibiotic. The
occurrence of nausea would be an adverse event, but it would not
be considered a medical error to have given the antibiotic if the
patient had an infection that was expected to respond to the chosen
antibiotic. Medical errors are adverse events that are preventable
with our current state of medical knowledge. Figure
1 (16 KB) shows this set of possible outcomes of medical care.
In this report,
the consideration of errors is broadened beyond preventable adverse
events that lead to actual patient harm to include "near misses,"
sometimes know as "close calls." A "near miss"
is an event or situation that could have resulted in an accident,
injury, or illness, but did not, either by chance or through timely
intervention. Experience in other industries, including aviation,
manufacturing, and nuclear energy, demonstrates that there is as
much to learn from close calls as there is from incidents leading
to actual harm.
It is also important
to situate medical errors within the broader context of problems
in health care quality. These can be classified under three categories:
overuse (the service is unlikely to have net benefit), underuse
(a potentially beneficial service is withheld), and misuse (a service
is inappropriately used) (Chassin,
1998). The majority of medical errors fall into the category
of misuse, but some problems with overuse (e.g., when an unnecessary
therapy is prescribed, leading to harm) or underuse (e.g., when
an error in diagnosis leads to the failure to apply timely treatment)
blur these distinctions. These are related quality problems and
may be addressed, in part, by using some of the same approaches.
In some cases, however, distinct approaches may be required. That
is why the IOM has chosen to deal with the issue of errors separately
in its report and plans to issue future reports on underuse and
overuse quality problems. Our report will also focus exclusively
on errors. Nevertheless, the QuIC participants recognize that the
improvements made in patient safety will lay the foundation for,
and may encourage, other quality improvements.
A Framework
for Thinking About Errors
There are many
possible ways to categorize medical errors, but no universally accepted
taxonomy. Classifications have included:
- Type of health
care service provided (e.g., classification of medication errors
by the National Coordinating Council for Medication Error Reporting
and Prevention).
- Severity
of the resulting injury (e.g., sentinel events, defined as "any
unexpected occurrence involving death or serious physical or psychological
injury" by the Joint Commission on Accreditation of Healthcare
Organizations [JCAHO]).
- Legal definition
(e.g., errors resulting from negligence [Institute
of Medicine, 1999]).
- Type of setting
(e.g., outpatient clinic, intensive care unit).
- Type of individual
involved (e.g., physician, nurse, patient).
Implicit in
the current variety of classifications is the understanding that
different types of medical errors are likely to require different
solutions and preventive measures. A single approach to error reduction
will fail because it does not account for important differences
in types of errors. For example, for the Food and Drug Administration
(FDA), product risk category may be a crucial dimension for shaping
regulatory policy, but a health care provider may see this dimension
as a minor consideration in shaping its error-control methods.
An "ideal"
classification of errors would need to be well suited to the purpose
to which it is being applied, but there is no single classification
system that could be successfully applied to the full set of IOM
recommendations being addressed by the QuIC. A framework for reporting
may include considerations of the level of reporting (Federal versus
State versus organizational), the reasons for which the reporting
is being done (learning versus accountability), or the level of
injury (near-miss versus minor versus severe). A framework for developing
a research agenda may require more focus on the populations involved,
available data, and research tools that can be applied to the problem.
The experience with the Aviation Safety Reporting System (ASRS),
which relies on narrative reporting without a formal framework,
demonstrates that rigorous classification may not be necessary at
all for some purposes.
The QuIC recommends
that the framework for analysis of errors in health care include
considerations of how to measure and improve patient safety. As
a result, the framework will evolve with each of the initiatives
outlined in this report, and the development of classifications
to deal with specific purposes will be part of the ongoing work
of the QuIC in addressing the IOM recommendations.
Lessons from
Other Industries
As noted in
the IOM report, health care is "a decade or more behind other
high-risk industries in its attention to ensuring basic safety"
(Institute of Medicine, 1999; p. 4).
Other sectors of the economy have made remarkable progress in error
reduction and safety assurance during the latter part of the 20th
century, much of which is attributable to industry’s attention to
quality management and improvement. In 1986, Motorola instituted
a strategy called "Six-Sigma Quality," whose name refers
to the Greek letter used to represent standard deviation from the
mean of any normally distributed curve (Chassin,
1998). A company which has six-sigma quality experiences only
3.4 defects or errors per million products or events. This is the
equivalent of seeing only one misspelled word in about six typical
mystery novels or one fumble in 1,600 football games.
Through the
six-sigma quality strategy, Motorola, General Electric, and others
have substantially reduced their error rates. These companies have
systems in place to monitor and report errors and defects so that
proper action can be taken, and it is no surprise that these companies
are the leaders in their respective industries. Although originally
devised for reducing defects in manufacturing plants, the application
of the six-sigma quality approach has provided benefits to service
industries as well (Chassin, 1998).
Service industries have used the six-sigma strategy to analyze,
for example, the number of customer complaints that go unanswered
after 2 days (per million complaints) or the excess waiting time
over 5 minutes a customer encounters before being served (per million
customers).
In another example,
the aviation industry has adopted quality improvement, safety assurance,
and error reduction as its core mission. Currently, airline safety
is operating at a five-sigma level (Chassin,
1998). The Federal Aviation Administration (FAA) strategic plan
targets a further 80 percent reduction in the airline accident death
rate, which would place it close to the six-sigma level. The cornerstone
of the FAA’s safety initiative has been the ASRS, which was established
in 1975. Although the ASRS is funded by the FAA, it is administered
by the National Aeronautics and Space Administration (NASA). Many
believe that this separation of control over the reporting function
to improve safety from the enforcement function is a critical factor
in its success. It gives credibility and a sense of safety to the
system in the eyes of the many users, particularly those being asked
to report their errors and near misses. The ASRS is a vital link
between those who observe or experience errors and defects and investigators
who have the ability to research and disseminate information regarding
these errors. In January 2000 the President signed an executive
order providing further protections to reporters under the aviation
safety system to enhance information collection. The aviation community
(as well as nuclear power and the military communities) has demonstrated
the importance of looking critically at human factors and interface
design practices in preventing accidents and increasing operating
efficiency (Rouse, Kober, and Mavor,
1997).
A review of
the experience in non-health-care industries offers some lessons
that may be applicable to reducing medical errors. Characteristics
of error-reducing industries include:
- Not tolerating
high error rates, and setting ambitious targets for error reduction
initiatives.
- Developing
tracking mechanisms that expose errors.
- Relying on
the abundant reports of errors and "near misses."
- Thoroughly
investigating errors, including a root causes analysis.
- Applying
to error reduction a systems approach that embraces a wide array
of human factors, technical, and organizational remedies.
- Focusing
on systems solutions that do not seek to find individual
fault and blame.
- Changing
the organizational culture so that it enhances safety and error
reduction.
- Allocating
adequate resources to error prevention initiatives and the development
of the knowledge base to support them.
- Recognizing
that solutions often come from unexpected sources, "out of
the box" thinking, and new combinations of disciplines (e.g.,
human factors psychology with aeronautical engineering).
The QuIC, in
reviewing the IOM report as well as these experiences in other industries,
has concluded that there is no single "magic bullet" approach
to reducing errors, but there is a generalizable approach (that
includes the strategies listed above) which, when applied vigorously,
is likely to yield favorable outcomes.
Unique Aspects
of Health Care Errors
Research, much
of it sponsored by AHRQ’s predecessor, the Agency for Health Care
Policy and Research, documents that the rate of health care errors
is far higher than the error rate in other industries. In one study
of intensive care units, the correct action was taken 99.0 percent
of the time, translating to 1.7 errors per day. One out of five
of these errors was serious and/or potentially fatal. If performance
levels even substantially better than those found in the ICU (for
example, 99.9%, a 10-fold reduction in errors) were applied to the
airline and banking industries, it would still equate to two dangerous
landings per day at O’Hare International Airport and 32,000 checks
deducted from the wrong account per hour (Leape,
1994). In these industries, such error rates would not be tolerated.
Health care
shares a number of characteristics with these other industries.
They all rely on systems which include the interaction of humans
and technology to perform a number of functions leading to an outcome
(e.g., a safe transcontinental flight, a check correctly deducted
from the right account, a patient’s recovery from breast cancer).
However, health care is distinct in its complexity. For example,
a patient in an intensive care unit is the recipient of an average
of 178 different activities performed per day that rely on the interaction
of monitoring, treatment, and support systems (Leape,
1994). One observer noted that many medical errors can be attributed
to the simple fact that the knowledge base to effectively and safely
deliver health care exceeds the storage capacity of the human brain
(Millenson, 1997).
The decentralized
and fragmented nature of the American health care industry contributes
to the problem of errors, and will make it a challenge to institute
the kind of comprehensive strategy to reduce errors and increase
patient safety that the IOM recommends in its report. The work of
federally-sponsored researchers such as Lucian Leape and David Bates
has illustrated the importance of focusing on the systems of health
care delivery in efforts to reduce medical errors. Prescription
and delivery of medications provides a dramatic example. It requires
the successful completion of at least five interdependent steps:
ordering, transcribing, dispensing, delivering, and administering.
Inattention to system design leads to numerous opportunities for
error in any one of these steps. One study on adverse drug events
showed that 78 percent of adverse drug events were due to system
failures (Leape, 1995).
Organizational
factors are also a distinct challenge in addressing medical errors.
Within many hospitals, departments are only loosely linked, and
communications between primary care doctors and medical specialists
are notoriously poor. As a result, information on problems, as well
as improved practices to reduce errors and enhance safety, in one
department or one facility do not migrate quickly to others. The
variety of settings in which health care is provided (including
hospitals, nursing homes, clinics, ambulatory surgery centers, private
offices, and patients’ homes) and the transitions of patients and
providers among them provide additional challenges.
Errors may be
particularly difficult to recognize in health care because variations
in an individual’s response to treatment is expected. In addition,
medical professionals may not recognize that a particular product
or procedure may have contributed to or caused the problem because
the patient is already ill, the product is not expected to work
perfectly at all times, or the event appears unrelated to the product
or procedure. Lack of recognition of a service’s role in adverse
events reduces reporting of the association and the opportunity
to learn from previous experiences with the product. Because medical
errors usually affect only a single patient at a time, they are
treated as isolated incidents, and little public attention is drawn
to these problems when compared with aviation or nuclear power accidents.
Health care errors are also underreported due to liability and confidentiality
concerns. These factors explain, in part, the ongoing "invisibility"
of medical errors despite the existence of research which has documented
their high prevalence.
Impact of
Organizational and Professional Culture
Although the
complexity of health care delivery systems is one of the factors
distinguishing health care from other industries, the professional
culture may pose an even greater challenge than does complexityto
improving patient safety. The "naming, blaming, and shaming"
approach to dealing with errors has hindered medical error reduction,
yet it is the most commonly used approach to addressing errors in
health care. In fact, this traditional approach has proven counterproductiveit
has driven the patient safety problem underground, leading to an
implicit "conspiracy of silence" where problems and close
calls are not discussed due to fear of reprisal (Koop,
1999).
Adverse medical
events have existed since the beginning of organized medical practice,
but may not have been recognized at the time of their occurrence.
Bloodletting and toxic "therapies," such as mercurials,
led to premature deaths, but these deaths were seen as a reflection
of the patient’s underlying illness rather than of harmful practice.
To some extent, that culture still persists in health care. Although
advances in medical technology and knowledge have eliminated these
historic practices, errors and mistakes continue to occur at an
unacceptably high rate in the delivery of health care. Contrary
to popular expectations, doctors, nurses, and other health care
professionals are inherently fallibleas are all humans.
The IOM report
notes that the majority of medical errors today are not produced
by negligence, lack of education, or lack of training. Rather, errors
occur in our health care systems due to poor systems design and
organizational factors, much as in any other industry. Health care
workers are placed in systems and settings where errors are bound
to happen. That is, the systems are designed to achieve a particular
set of goals, but inadvertently produce a certain level of errors.
For example, health care workers are sometimes expected to work
24-hour shifts to ensure patients are cared for and have some continuity
of care, although it is known that overwork and fatigue lead to
decreased mental concentration and alertness. These caregivers are
expected to function in an environment that is not ergonomically
designed for optimal work performance. They are expected to rely
on their memories and deliver safe care without substantial investments
in information technology or even the simple application of checklists.
They often deliver care through a set of complex processes, although
industry has shown that the probability of performing a task perfectly
decreases as the number of steps in the process increases. Finally,
they are expected to work in a climate where one error, even if
not preventable, may mean a catastrophe or the end of a career.
By not improving
the systems in which medicine is practiced, the health care industry
as a whole has not advocated a culture of safety and is not well
organized to tackle the challenge of improving patient safety. Only
when the entire industry is able to make patient safety and the
reduction of medical errors its first priority will errors in medical
practice be reduced.
A Global
Challenge
The medical
errors epidemic is a global problem. The United Kingdom, for example,
has had some well-publicized difficulties with pediatric surgery
outcomes in Bristol. British authorities estimate that 40,000 hospitalized
patients die annually as a result of errors, which translates to
a 3.7 percent overall rate of errors. The Australian Review of Professional
Indemnity Arrangements for Health Care Professionals (Commonwealth
Department of Human Services and Health, 1995) also found error
to be a serious cause of morbidity and mortality. Australia, the
United Kingdom, and Sweden are among the countries that have begun
to address this issue. The British Ministry of Health is in the
process of making funds available to researchers to investigate
medical errors, and is re-engineering its clinical governance programs
to provide mechanisms to improve patient safety. Australia has included
medical errors as part of its focus on quality, and is initiating
a national system for error reduction with enhanced reporting mechanisms.
However, efforts to actually translate the limited research available
into practice are still at an early stage, at best. Approaches are
likely to vary across nations because of differences in health care
organization, attitudes toward regulation, and views on patient
information and confidentiality. The evidence informing those approaches,
however, is likely to be more universal. As a global leader, the
United States has a responsibility to the many countries that do
not have the resources to devote to the study of this issue.
Evidence
of Errors
The Epidemiology
of Medical Errors
Errors and other
adverse events occur regularly in health care settings, but the
causes, frequency, severity, preventability, and impact of these
events on patient outcomes are not completely understood. A few
studies have found an alarmingly high prevalence of adverse events
and medical errors in some hospitals. In two large studies of hospital
admissions, one in New York using 1984 data and another in Colorado
and Utah using 1992 data, the proportions of admissions in which
there were adverse events (defined as injuries caused by medical
management) were 2.9 and 3.7 percent, respectively (Leape,
1991; Gawande, 1999). In the
New York study, errors (defined as avoidable "mistakes in performance
or thought") were determined to have caused more than half
of the adverse events. However, the absence of standardized definitions
of medical error, the lack of coordination and integration of systems
to report and monitor errors, and the difficulty in distinguishing
preventable errors from currently unavoidable adverse events hamper
our understanding of this problem. It is unlikely that we can ever
know the precise frequency with which errors occur in health care
settings because we must rely on people to recognize that errors
were made, to distinguish them from bad outcomes of appropriate
treatment, and then to report them.
Adverse
Events and Medical Products Use or Misuse
Preventable
injuries and deaths from pharmaceutical drugs are a growing problem
that, according to some studies, represents a leading cause of death
and patient harm in the United States (American
Hospital Association, 1999; Centers
for Disease Control and Prevention, 1999; Leape,
1991). Although the methods used to measure the rate of errors
associated with the use of drugs have significant limitations, researchers
have estimated that more than 50 percent of prescriptions are used
incorrectly (Porter and Jick, 1977).
Problems related to the use of pharmaceutical drugs account for
nearly 10 percent of all hospital admissions, and significantly
contribute to increased morbidity and mortality in the United States
(Bates, 1995).
In the Harvard
Medical Practices Study of adverse medical events (Leape,
1991), which was based on 30,195 randomly selected records from
51 hospitals in New York State, the researchers found that drug
complications represented 19 percent of all adverse events. The
researchers concluded that 58 percent of injuries and deaths due
to drug reactions were preventable, and 27.6 percent of such complications
were due to negligence. According to this study, antimicrobial drugs
were the class of agents most commonly associated with adverse drug
events. Misuse of antimicrobial drugs not only exposes individual
patients to an increased risk of a poor treatment outcome, but also
leads to the emergence and spread of drug-resistant microorganisms,
which may place other patients and health care workers at risk of
infection.
The specific
problem of medication errors has drawn considerable public attention,
since all such errors are preventable. Medication errorsmistakes
in writing prescriptions, dispensing or administering drugsare
a subset of the larger category of errors involving drugs. In a
case–control study covering a 4-year period at a single hospital,
it was determined that there was an almost 2-fold increase in the
risk of death attributable to such errors. In the previously cited
Harvard Medical Practice Study, 19.4 percent of all disabling adverse
events were caused by drugs, of which 45 percent were due to medication
errors. In that study, 30 percent of those with drug-related injuries
died.
In addition
to drug-related injuries and deaths that occur in hospitals, information
is available indicating that preventable, drug-related injuries
are also occur at a high frequency among out-patients. In a study
of 1,000 ambulatory patients drawn from a community, office-based
medical practice (Burnum, 1976),
the researchers noted side effects from drugs in 42 patients (4.2
percent), including 23 who experienced preventable side effects.
Well-understood drug–drug interactions are preventable, but there
is evidence that physicians do not routinely screen for them, even
when a patient’s medication history is readily available. In a study
of 424 randomly selected visits to a hospital emergency department
(Beers, 1990), 47 percent of visits
resulted in the patient receiving a prescription for a medication.
In 10 percent of these instances, the new medication could potentially
harm the patient due to an avoidable drug-drug interaction. In all
of these cases, a medication history had been recorded and available
to the prescribing physicians.
Thus, it can
be seen that preventable and avoidable injuries due to drugs constitute
a significant public health concern. The increasing use of drugs,
the growing fragmentation of health care delivery, and the competing
demands of an overburdened health care delivery system will, undoubtedly,
accentuate these problems.
Current Programs
to Prevent Errors
Local Performance
Measurement and Performance Improvement Systems. In the past
decade, health care facilities and health plans have placed an increasing
emphasis on improving health care quality. The impetus has come,
at least in part, from patients, purchasers, accreditation agencies,
and regulators determined to obtain the best value for the Nation’s
health care dollars. Today, virtually all health care organizations
have programs to measure and/or improve health care quality.
Many hospitals
and health plans collect and monitor data relevant to specific events
(e.g., patient falls, failure to appropriately administer beta-blockers
after myocardial infarction) or health outcomes (e.g., anesthesia
mortality, length of stay after total hip replacement), which may
or may not reflect medical errors. Hospitals commonly use these
data for performance measurement or continuous quality improvement.
Decisions about what will be monitored are usually based on the
nature, severity, and importance of perceived problems at the local
level, the feasibility of accessing data and formulating a response,
and related incentives (e.g., meeting standards required for accreditation,
anticipated cost-savings). Similarly, some hospital departments
(e.g., pharmacy, nursing) use performance measurement to target
treatment errors and other adverse events.
Performance
measurement and quality improvement programs are less common and
often less extensive outside of acute-care hospitals. Programs in
risk management as well as more recently developed programs in what
has been called "disease management" or "outcomes
management," although aimed at improving health outcomes, generally
have not specifically included error reduction in their scope. Occupational
health or employee health programs, in addressing risks to health
care workers, may also impact patient safety and quality of care.
Overall, the degree to which these local programs address medical
errors or other preventable adverse events and, more importantly,
the extent to which they motivate changes that improve the overall
heath status of patients, are not known. Part of the research agenda
will be to see if market forces favor those health care organizations
that improve patient safety.
Programs of
infection prevention and control provide long-standing and successful
examples of health care programs specifically designed to prevent
adverse health events. These programs have been shown to reduce
morbidity and mortality due to health care-associated infections.
For this reason, infection control programs are mandated as a condition
of accreditation for health care facilities. In hospitals, accreditation
standards require a minimum number of trained infection control
personnel and delineate specific program components. Such programs
usually include ongoing monitoring (surveillance) of infection rates
by trained infection control personnel using standardized case definitions,
analysis of data with adjustment for facility and patient characteristics
known to affect risk, comparison of local rates to aggregate benchmark
data, prompt feedback of infection rates and trends to providers
and decisionmakers, and targeted interventions that address specifically
identified problems. This approach parallels that used in industrial
continuous quality improvement programs and in industrial quality
control. In nonhospital facilities, accreditation standards are
less rigorous, and the composition and quality of infection control
program is variable.
Regional and
National Programs. Some regional and national external reporting
systems to monitor errors and adverse health events already exist.
FDA operates systems monitoring adverse events associated with drugs,
medical devices, vaccines (co-managed with CDC), and blood and blood
products. CDC’s NNIS monitors health care-associated infections. Some
State health agencies (e.g., those of New York, Massachusetts, Florida)
also monitor targeted health events. Nongovernmental agencies (e.g.,
JCAHO and the U.S. Pharmacopeia, through their Sentinel Events and
Medication Errors Reporting Programs, respectively) also operate error
reporting systems.
Such external
programs motivate local efforts to recognize and address problems,
provide norms to which local efforts can be compared, and identify
emerging problems (e.g., adverse drug events or manufacturing errors)
that may require governmental or other system-wide response. For
example, reported errors related to medical products can lead the
FDA to require changes in package inserts and promotional materials,
modifications in product packaging, and widespread dissemination
of information through letters to health professionals and published
alerts.
Most reporting
systems have little or no enforcement authority to assure that reporting
of errors is occurring consistently and completely. A recent report
from the Department of Health and Human Service’s (DHHS) Inspector
General found that there is widespread underreporting to FDA's drug
adverse event reporting system, despite the fact that more than
270,000 incidents are reported annually. In addition, even though
these programssome of which may be considered mandatorymay
promise the opportunity to report errors and near-misses confidentially,
those who submit reports (e.g., clinicians and hospitals) have expressed
concern about their legal vulnerability in these reporting systems.
Another reason for low rates of reporting in some systems is that
information on how to prevent similar errors in the future is not
fed back to the reporters. Therefore, these reporters see little
benefit in completing and submitting reports.
Accomplishments
of Programs to Prevent Medical Errors
Despite the
strikingly high incidence of medical errors documented in the IOM
report, and the difficulties in obtaining reports on errors and
near misses, there are remarkable examples of successful efforts
to improve patient safety. Surgical anesthesia, which once had an
error rate of 25 to 50 per million patients, reduced its error rate
nearly 7-fold. (Orkin, 1993). The
first step in reducing surgical anesthesia error rates was the collection
of data that permitted a systems analysis of errors, rather than
a hunt for "responsible" individuals. Through teamwork,
practice guidelines, automation, procedure simplification, and standardization
of many functions, anesthesiologists demonstrated that a properly
designed system can either prevent mistakes or prevent mistakes
from doing harm.
Another example
of success is the advances in patient safety that have been achieved
in the Department of Veterans Affairs (VA), through its Veterans
Health Administration. For instance, a hand-held, wireless bar-coding
system was introduced into VA and has reduced medication errors
by 70 percent at relatively low cost (Gebhart,
1999). It is particularly interesting that this approach was
adopted from a completely different industryfrom observation
of how Avis checked in returned rental cars. Similar behavioral
and cultural changes must occur in other segments of the health
care industry in order to address the patient safety issue fully.
Many Federal
agencies have learned that the creation of a comprehensive knowledge
base, rich in textual description of all aspects of errors occurrence,
must be developed if preventive efforts are to be targeted and effective.
One hopeful sign has been the development of private-sector organizations,
such as the National Patient Safety Foundation (NPSF), the National
Coordinating Council for Medication Error Reporting and Prevention,
and JCAHO, which are promoting research and improvement initiatives
focused on systems approaches to error reduction.
The occupational
health field has demonstrated that human factors engineering can
identify ergonomic concepts to prevent injuries to both patients
and workers. Examples include curving the design of hallway corners
to reduce the risk of injury from collisions, using mechanical lifts
to prevent patient falls and employee back injuries, and reducing
the number of scheduled work hours in a rotating shift to minimize
the likelihood of errors resulting from fatigue and sleep deprivation.
Insufficiency
of Existing Programs
Effective error
prevention systems need to be built on a foundation of locally directed
and managed programs within health care organizations, complemented
by coordinated, external support and guidance from Federal, State,
and nongovernmental agencies and organizations. Within this framework,
a comprehensive approach to error reduction would require specifically
designated personnel working in or consulting with each health care
setting to:
- Identify
and monitor the occurrence of errors in targeted patient populations
at greatest risk, and understand their root causes, especially
those that are preventable.
- Analyze,
interpret, and disseminate data to clinicians and other stakeholders.
- Implement
error reduction strategies based on reanalysis and reworking of
health care systems.
- As necessary,
call upon experts with clinical, epidemiologic, and management
training and experience for technical support and to conduct on-site
investigations.
- Evaluate
the impact of these programs on patient safety.
A number of
factors reduce the effectiveness of existing programs to prevent
medical errors. Performance measurement and improvement programs
within health care organizations do not directly address the problem
of medical errors. Programs that have been specifically developed
to prevent medical errors often operate in isolation. In addition,
programs such as infection control and employee health and safety
typically receive low priorities within health care centers.
Efforts by external
organizations to monitor errors also face limitations. A number
of different programs exist to detect adverse health events, although
no one system is designed to detect the full scope of medical errors.
Passive surveillance
systems, such as the National Notifiable Diseases Surveillance Systemin
which health care providers and laboratories report incident cases
of diseases (mostly infectious) to the State health departmentwhile
broad in scope and coverage, are often hampered by collection of
incomplete data. Each State determines the diseases that are reportable,
resulting in some differences across States. Furthermore, health
care providers must remember which diseases are reportable, and
take the time to report them.
Active surveillance,
on the other hand, means soliciting case reports in a timely manner
directly from potential reporting sources. Examples of this type
of reporting include HIV/AIDS reporting, in which CDC provides funding
to State and local health departments to support the surveillance
process. These active surveillance systems provide more complete
and accurate information, but are expensive to implement and maintain.
Systems designed to hold organization or individual accountable
for bad outcomes are commonly limited by underreporting of adverse
events.
Although quality
improvement programs within health care organizations could be enhanced
or adapted to address errors, obstacles remain. The more serious
are:
- Lack of awareness
that a problem exists.
- A traditional
medical culture of individual responsibility and blame.
- The lack
of protection from legal discovery and liability, which causes
errors to be concealed.
- The primitive
state of medical information systems, which hampers efficient
and timely information collection and analysis.
- Inadequate
allocation of resources for quality improvement and error prevention
throughout the health care system.
- Inadequate
knowledge about the frequency, cause and impact of errors, as
well as about evidence of effective methods for error prevention.
- Lack of understanding
of systems-based approaches to error reduction (such as those
used in aviation safety or manufacturing) and the perceived difficulty
of adapting those approaches to the health care sector.
There are even
greater barriers to error reduction in nonhospital settings, where
the general absence of organized surveillance systems and lack of
adequate personnel hinder local data collection, feedback, and improvement.
Lack of awareness.
As stated earlier, the existence of medical errors has been
known for some time. However, the fact that there has been very
little success in reducing errors suggests that a general lack of
awareness or alarm about errors is a factor in this failure. The
awareness of the problem of medical errors and any subsequent solutions
must be improved, not only among physicians, nurses, pharmacists,
dentists, and other health care providers, but also among patients,
policymakers, and the many other stakeholders of the health care
community.
Barriers
to partnership. The punitive and pejorative connotations of
"error" as the object of investigation pose a potential
barrier to the unfettered cooperation and collaboration of health
care providers in establishing and managing effective error control
programs. A cultural change needs to occur that will enable health
care providers and leaders, as well as the public, to talk about
errors and recognize that they are, in large measure, a result of
faulty systems and faulty system design, not of individual failures.
Legal barriers.
A system which supports learning from errors is dependent upon
reporting, but fear of reprisal or legal action will dissuade many
potential reporters. Assurances that the identity of reporters will
be masked or never collected at all have been shown to enhance reporting
in other industries (e.g., the ASRS). Disclosure of the individuals
or organizations involved in an incident could also discourage reporting.
There will remain instances, however, where criminal or negligent
acts demand appropriate disclosure. The legal issues surrounding
patient safety will have to be examined carefully to determine the
best mechanisms to promote learning from errors while protecting
the public.
Information
systems and technical problems. To be practical, error prevention
will need to rely on sophisticated management and clinical information
systems, both as sources of data on adverse events and as a component
of interventions to reduce errors, such as through the adoption
of computer-based decision-support for health care providers. However,
information systems in most health care organizations are neither
sufficiently integrated nor flexible enough to serve either of these
purposes. Technical support and research into information system
desifgn will be required to address this problem.
Cost and
structural concerns. Although considerable cost savings could
be realized by effective reduction in medical errors, instituting
such programs will require a substantial initial investment. In
addition, the relative autonomy of departments within some health
care institutions is a potential barrier to rapid organizational
change and the adoption of new models and procedures needed to prevent
errors.
Deficiencies
in knowledge and understanding. The epidemiology of errors is
not well understood. Standardized definitions of errors and adverse
events need to be developed and the methods of collecting meaningful
data require further study. Research is needed to help distinguish
between adverse events due to errors, unavoidable consequences of
treatment, and complications caused by a patient’s underlying disease.
The current paucity of fundamental and applied research on medical
errors limits the tool kit of effective interventions that can enhance
patient safety.
Lack of appropriate
collaboration among disciplines. Because of the nature of medical
errors, an effective response requires an integration of efforts
across traditional occupational and scientific boundaries. The nature
of the patient safety challenge requires synergy among scientific
and technical disciplines, from human factors psychology to product
design and delivery. This collaboration is needed at all stages
of the effort to reduce errors and enhance patient safetyfrom
research on its causes and remedies to implementation and partnership
in its reduction and elimination. The response to medical errors
by the health care system is hindered by the traditional focus of
single disciplines on individual providers or on products, and even
by poorly coordinated efforts among Government agencies and with
the private sector.
Failure
to apply a coherent strategy. The variety of medical errors
and the multidimensional nature of the patient safety challenge
demand a variety of approaches for improvement. Experience from
other industries demonstrates, however, that successful interventions
to address different types of errors can consistently result from
the application of a coherent strategy that includes intolerance
of high rates of error, development of tracking mechanisms, root
cause analysis, the application of innovative resources and relationships
to address the problem, and an institutional devotion to error prevention.
The QuIC concludes
that systems designed to facilitate quality improvement through
error reduction can generate effective, useful reporting if those
individuals who report are assured of confidentiality, protected
from legal liability resulting from the report, provided with timely
feedback on data from the system, and are not unduly burdened by
the effort involved in reporting.
Chapter
2. Federal Response to the IOM Report
In this chapter,
the QuIC responds to recommendations from the IOM report and describes
how the Federal Government can act on the issues of medical error
and patient safety. This includes responses by the QuIC, as an interagency
coordinating organization, as well as responses by individual agencies
of the QuIC.
National
Focus and Leadership
Center for
Patient Safety
IOM Recommendation
Congress should
create a Center for Patient Safety within the Agency for Health
Care Policy and Research. This Center should:
- Set the national
goals for patient safety, track progress in meeting these goals,
and issue an annual report to the President and Congress on patient
safety.
- Develop knowledge
and understanding of errors in health care by developing a research
agenda, funding Centers of Excellence, evaluating methods for
identifying and preventing errors, and funding dissemination and
communication activities to improve patient safety (IOM;
1999, page 6).
QuIC Response
The IOM’s recommendations
build upon AHRQ’s focus on health care quality, its expertise, and
its track record in funding research, training, and dissemination
activities. AHRQ will take immediate action to expand the mission
of the Center for Quality Measurement and Improvement, creating
the Center for Quality Improvement and Patient Safety (CQuIPS),
which will provide leadership in reducing medical error and improving
patient safety. Integration of the patient safety agenda within
AHRQ’s existing quality improvement efforts reflects an approach
similar to that used by the IOM, in which its work on patient safety
was included within a broader "Quality in America" framework.
The formation
of CQuIPS explicitly recognizes that patient safety and quality
improvement are complementary activities with great potential for
synergy. Furthermore, establishing the Center takes advantage of
AHRQ’s current infrastructure, which includes a center focusing
on quality improvement and a task force that advises the Director
on matters related to patient safety and medical errors. The Center
will develop initiatives in these areas and facilitate communication
between the Agency and external organizations. In the Center’s first
year, the President has proposed a budget of an additional $20 million
to be spent on research.
The Center will:
- Conduct and
provide grants and contracts for extramural research on patient
safety and the causes of medical errors, and on the effectiveness
of programs to reduce them.
- Include patient
safety within the broader focus of quality measurement and improvement.
- Bring together
individuals and groups from the public and private sectors with
an interest in patient safety.
Because the
Center’s role will not include regulatory, payer, or provider functions,
it is well positioned to share information from both the private
and public sectors (e.g., pooling and analyzing results of State
mandatory error reporting systems). Additionally, patient safety
will be integrated into the activities of other organizational units
within AHRQ.
The Center’s
functions will be coordinated with and complementary to other private-sector
and Federal initiatives focused on error reduction and improved
patient safety. For example, VA, CDC, HCFA, FDA, DoD, the National
Patient Safety Foundation (NPSF), the National Patient Safety Partnership
(NPSP), and professional societies all have expertise relevant to
identifying and reducing medical errors and improving patient safety.
Their collaboration via the QuIC will enhance the Center’s functions.
One example of such collaboration will be the Center's development
of a curriculum for QuIC participants on reducing medical errors
that can be used as a model and expanded by other public- and private-sector
organizations.
Actions
- AHRQ will
take immediate action to establish the Center for Quality Improvement
and Patient Safety (CQuIPS), which will replace and broaden the
mission of AHRQ’s Center for Quality Measurement and Improvement.
- CQuIPS will
coordinate with and complement other public- and private-sector
initiatives to improve patient safety.
- QuIC will
coordinate Federal activities on patient safety, as it does on
the broader quality agenda. This will include both regular meetings
of the QuIC and use of its current structure to redirect QuIC
working group efforts towards enhancing patient safety.
- AHRQ will
sponsor a program to educate personnel of QuIC member agencies
about patient safety, bringing them together with leading researchers
on human factors analysis, systems design, error reporting, and
quality improvement. This curriculum will serve as a model and
be expanded for future educational activities with private-sector
partners.
- QuIC agencies
such as OPM, HCFA, DoD, and VA will demonstrate their national
leadership as purchasers and providers of care, developing model
programs that use information on errors to improve patient safety.
- Federal agencies
and other bodies, including AHRQ, FDA, CDC, and HCFA, will collaborate
to provide national leadership in developing and testing systems
of mandatory reporting for public accountability.
Research
Planning
IOM Recommendation
Develop a research
agenda, conduct and fund intramural and extramural research to assess
the magnitude of errors and the role of human factors, and test
and evaluate approaches for preventing errors.
QuIC Response
A substantial
research program is central to the overall effort to improve patient
safety and reduce medical errors. Without the evidence base that
research provides, efforts to reduce errors and improve safety are
unlikely to be fully productive, and may even be harmful. An example
of an event with potential for harm is the automation of health
care processes without due consideration of system design and human–technology
interfaces. Automating a flawed system may invite errors and further
mask their occurrence.
Research also
is needed on the role of patients in helping to reduce errors. While
much is known about the power of patient participation in helping
to improve overall patient outcomes and satisfaction, research is
sparse regarding the patient’s role in error reduction (e.g., wrong-site
surgery, medication errors). In general, further research is needed
on how best to measure medical errors, explore options for reporting
them, understand why they occur, and test the success and cost-effectiveness
of various approaches to improving safety, including the patient’s
role in helping to prevent errors.
A number of
research activities are currently underway in Federal agencies and
departments. In December 1999, AHRQ released a request for grant
applications to research the effectiveness of the transfer and application
of "best practices" to reduce medical errors that are
frequent, serious, and preventable. AHRQ also is supporting a project
conducted by the NPSF that identifies and gathers information on
public- and private-sector agencies and organizations funding research
on medical errors and patient safety. This is effort helps to coordinate
research initiatives, prevent overlaps, and identify research gaps.
Other agencies
and departments also have research projects underway. VA is evaluating
grant applications focused on mitigating adverse drug events and
has established four Patient Safety Centers of Inquiry to develop
innovative solutions to critical challenges in patient safety. HCFA
is funding the Study of Clinically Relevant Indicators for Pharmacologic
Therapy (SCRIPT) to develop and test a core set of measures that
can be used to evaluate and improve medication use associated with
significant morbidity, mortality, and unnecessary cost. The FDA
is strengthening its understanding of the impact of pre- and postmarket
risk management decisions, which includes exploring the association
between errors and medical products, human factors and pharmaceutical
name confusion, patient communication, exposure to risk, and improved
methods for extracting information from both large reporting databases
and patient medical records.
Federal agency
collaborative efforts also are underway. For example, in 1999 AHRQ
funded four Centers for Education and Research on Therapeutics (CERTs).
Established as part of the FDA Modernization Act of 1997 and administered
by AHRQ in collaboration with the FDA, the CERTs examine the benefits
and risks of new drugs, biologics, and medical devices. Under the
aegis of the QuIC, several agencies and departments will implement
a project in 2000 focused on identifying and reducing medical errors
in high-hazard health care environments.
While important
and timely, however, these initiatives fall short of meeting the
ambitious research agenda described in the IOM report.
The QuIC proposes
a broad research initiative aimed at developing evidence-based approaches
to reducing medical error and improving patient safety, but it will
require substantial additional funding. With coordination, direction,
and input through AHRQ’s new CQuIPS, this initiative will include
setting a coordinated research agenda, supporting research and demonstrations,
evaluating programs, developing tools and training initiatives,
and disseminating findings. Potential components of this initiative
are outlined below.
Actions
- Hold national
summits on medical error and patient safety research: AHRQ will
lead the convening of conferences and expert meetings to review
the information needs of those who wish to improve safety, assess
the current state of patient safety research, set coordinated
research agendas, and develop adequate reporting mechanisms. VA
will lead a summit on lessons learned from its experiences in
improving patient safety, and the FDA will lead a summit on drug
errors. These summits will take place within 1 year.
- Establish
joint research solicitations (including partnerships between AHRQ,
CDC, FDA, and VA) for:
Fundamental
Research on Errors: Investigate root causes analysis, informatics,
the role(s) of human factors, and legal/judicial issues.
Research on Reporting Systems: Identify critical
components of successful reporting systems used for learning,
examine options for voluntary and mandatory reporting systems,
implement and evaluate demonstration programs for reporting, evaluate
existing State mandatory reporting systems, and investigate techniques
and methods for analyzing and disseminating patient safety data
(including integration into a National Quality Report being prepared
by DHHS under the leadership of AHRQ and CDC).
Applied Research on Patient Safety: Test the application
of human factors knowledge to the design of health care products,
processes, and systems; identify best practices in reducing errors;
fund patient safety "Centers of Research Excellence";
and support research and demonstrations on-site, as well as level-of-care
and cross-cutting research, such as in diagnostic accuracy, informatics
applications, and systems re-engineering.
- Develop tools
for the public and private sector to support efforts to enhance
patient safety, including:
Applications:
Identify tools and approaches from other industries that could
be applied to the health care sector and develop community-based
settings that can serve as laboratories for error reduction through
medical specialty societies, primary care networks, and integrated
service delivery networks.
Measures: Develop and evaluate data specifications
for reporting on patient safety and work with the Quality Forum
and other private- and public-sector efforts on developing consensus
around a core set of measures for patient safety.
- Finalize
a QuIC Research Agenda on Working Conditions and Patient Safety.
The QuIC will finalize a research agenda to explore the relationship
between health care workers’ working conditions and the quality
of patient care, including patient safety. CDC and AHRQ will coordinate
this activity with VA and other agencies.
Identifying
and Learning From Errors
IOM Recommendations
A nationwide
mandatory reporting system should be established that provides for
the collection of standardized information by State governments
about adverse events that result in death or serious harm. Reporting
should initially be required of hospitals and eventually be required
of other institutional and ambulatory care delivery settings. Congress
should:
Designate
the Forum for Health Care Quality Measurement and Reporting as the
entity responsible for promulgating and maintaining a core set of
reporting standards to be used by States. Reporting standards should
include a nomenclature and taxonomy.
Require all health care organizations to report standardized
information on a defined list of adverse events.
Provide funds and technical expertise for State governments
to establish or adapt their current error reporting systems to collect
the standardized information, analyze it, and conduct followup action
as needed with health care organizations. Should a State choose
not to implement the mandatory reporting system, the Department
of Health and Human Services should act as the body responsible
for data collection and analysis. Further, the Center for Patient
Safety should be designated to:
- Convene
States to share information and expertise, and evaluate alternative
approaches taken for implementing reporting programs, identify
best practices for implementation, and assess the impact of
State programs.
- Receive
and analyze aggregate reports from States to identify persistent
safety issues that require more intensive analysis and/or a
broader based response (e.g., designing prototype systems or
requesting a response by agencies, manufacturers or others).
The development
of voluntary reporting efforts should be encouraged. The Center
for Patient Safety should:
- Describe
and disseminate information on external voluntary reporting programs
to encourage greater participation in them and track the development
of new reporting systems as they form.
- Convene sponsors
and users of external reporting systems to evaluate what works
and what does not work in the programs and ways to make them more
effective.
- Periodically
assess whether additional efforts are needed to address gaps in
information to improve patient safety and to encourage health
care organizations to participate in voluntary reporting programs
and
- Fund and
evaluate pilot projects for reporting systems, both within individual
health care organizations and within collaborative efforts among
health care organizations.
QuIC Response
The IOM report
states that to decrease the incidence of errors in the health care
system, it is necessary to have and use information. The IOM’s recommendations
reflect two important information needs that are vital to efforts
to improve safety. First, the public expects and has a right to
information that will demonstrate that the health care delivery
system is as safe as possible. Second, there is the need for data
and information in support of efforts to learn why errors occur
and what changes are effective in preventing errors or minimizing
their effects. Both needs can be met only through the development
of effective data collection systems. Additionally, accountability
and learning will only be achieved if the data are analyzed and
information is fed back to the users.
The kind of
information that is produced from these systems needs to be useful
to those who can act on it. Learning systems must be designed to
produce information for providers, drug and device manufacturers
and others. Accountability systems must meet the information needs
of the public, public policymakers, and purchasers. The data needs
for accountability and those for learning are complementary but
not identical.
The QuIC believes
that the IOM is correct in identifying these information needs,
and will take steps—in collaboration with a variety of other organizations—to
begin to meet them. As appropriate, the QuIC supports the extension
of peer review protections to encourage reporting. Details of these
extensions are given in "Peer Review Protections," below.
Accountability
The Federal
agencies are committed to providing the public with information
about the safety of the health care delivery system, in general,
and about the providers from which they can choose. To that end,
the QuIC proposes that the Quality Forum identify those patient
safety practices that health care organizations have adopted and
that have been proven through research to be effective in reducing
errors. The QuIC anticipates that the Quality Forum will encourage
health care organizations to adopt these practices and inform the
public of their use.
As a start,
OPM will require that the provider organizations with which it does
business have patient safety programs in place and provide public
information on what those programs do. This information will be
disseminated broadly on OPM’s Web site and through other mechanisms
available to it. Methods for insuring this reporting are further
described in "Raising the Standards
for Health Care Organizations" and "Raising
the Standards for Health Care Professionals."
While information
on what programs are in place will be useful, it may not be sufficient
to ensure the public is able to make the decisions it wants to make
about its health care. Therefore, the QuIC proposes to look at how
to provide useful information on errors to the public. This examination
will consist of two separate parts.
First, AHRQ
will lead a QuIC effort to examine the existing State reporting
systems that have been designed for public accountability, to learn
what their common characteristics are, how effective they have been
in providing information to the public, and what have been the most
successful elements of those programs. This information will be
shared with the States that currently operate error reporting systems
and others that are considering developing such systems, as a means
of encouraging improvement and expansion of State reporting. The
goal would be for all States to have a reporting system for errors
within 3 years. If, at the end of 3 years, all States have not implemented
reporting systems, the QuIC will recommend options to the President
so that all health care institutions are reporting serious errors.
Second, HCFA
will experiment with creating its own program for collecting and
reporting publicly on medical errors that result in significant
harm to patients and are preventable, given the current state of
knowledge. Examples of such events are: surgery on the wrong body
part, surgery on the wrong patient, and suicide while the patient
is being watched to prevent a suicide. HCFA proposes to conduct
a pilot study of such a mandatory reporting system for these events
in collaboration with a State. It will work with the Quality Forum
or similar entity to develop a finite list of events to be reported,
and will ensure they have unambiguous definitions. In addition,
HCFA will ask the Quality Forum or other entity to advise it on
how best to report the information to the public to ensure it is
understandable and useful.
HCFA will work
with the chosen State to require that such events are reported by
all hospitals in the State and published on a hospital-by-hospital
basis. The published data will be stripped of all information that
might jeopardize patient confidentiality. In the course of the pilot
study, HCFA will refine any definitions and work out the operational
issues of enforcement and reporting mechanics with the State Survey
and Certification agency. HCFA and its QuIC partners will evaluate
whether consumers found this information valuable and what they
understood about it, and how they used it. Finally, HCFA and its
QuIC partners will evaluate the impact of such a system on confidential
reporting for learning from errors.
If successful,
based on the results and evaluation of the pilot study by HCFA and
its QuIC partners, HCFA will move towards a national mandatory reporting
system for all hospitals participating in the Medicare program,
with the intent of making the data publicly available.
Serious errors
and accidents also occur during the collection, testing, and administration
of human blood. On January 27, 2000, the DHHS Advisory Committee
on Blood Safety and Availability recommended, among other things,
facilitating development of technology to prevent misidentification
of blood products and/or recipients. By the end of the year, FDA
will release regulations to improve the safety of blood transfusions
by requiring the over 3,000 blood banks and establishments dealing
with blood products to report errors and accidents, such as mistyping
blood products and adverse events affecting donors, that affect
patient safety. Currently, only 400 blood banks are required to
report such errors.
In addition
to broad public accountability, the IOM asserted that providers
have the responsibility to provide information to affected individuals
and their families about mistakes that cause serious injury or death.
The QuIC agrees with this recommendation. However, subsequent investigations
by the health care organization into the causes of error need not
be shared.
Actions
- The QuIC
will ask the Quality Forum to define unambiguously, within 12
months, a set of egregious errors that are preventable and should
never occur. These measures will serve as criteria for a HCFA-sponsored
mandatory reporting demonstration project with a State that already
has an existing mandatory reporting requirement. HCFA will publish
the hospital rates for these events without patient identifiers.
- HCFA and
its QuIC partners will evaluate whether consumers found this information
valuable and what they understood about it. Based on these results,
HCFA will move towards a national mandatory reporting system,
with publication of findings, for all hospitals participating
in Medicare.
- Federal agencies,
in partnership with other organizations, will develop options
for mandatory reporting systems that provide the public and purchasers
with publicly available information about programs and procedures
in place to reduce errors. This work will require the development
of evidence-based, systems-level measures in collaboration with
the Quality Forum.
- OPM will
require that health plans have error reduction plans, and will
report on its Web site whether the health plans have reliable
patient safety initiatives in place.
- QuIC will
ask the Quality Forum to identify, within 12 months, patient safety
practices that institutions should undertake and urges that information
about whether the measures are in place be made available to the
public.
- FDA will
report to the public on the safety of drugs, devices, and biologic
products.
- QuIC proposes
that State and Federal mandatory reporting systems, as well as
those of private accrediting and other oversight groups, be evaluated
to determine the ways in which they are helpful in assuring public
accountability for patient safety, and that these results be used
to develop future reporting systems.
- AHRQ will
include information on patient safety in the National Quality
Report it is developing in collaboration with other agencies,
in particular, the National Center for Health Statistics.
- OPM will
require that health plans describe their patient safety initiatives,
will make patient safety information available in both print and
electronic formats for the open enrollment period in Fall, 2000,
and will expand its web site to include information about programs
designed to reduce errors and enhance patient safety.
- OPM will
encourage health plans to annotate Preferred Provider Organization
(PPO) directories to indicate which hospitals and physicians’
offices use automated information systems.
- FDA will
improve the safety of transfusions by expanding mandatory reporting
requirements for blood bank errors and accidents, so that they
apply to all registered blood establishments.
Learning
from Errors
To learn from
errors, the aviation industry experimented with different models,
but found it most useful to have a large national database of information
that can be analyzed for patterns of underlying causes of mistakes.
This ensures that data from events that rarely occur, but which
have dire consequences, can be more readily identified. At the moment,
no comprehensive system of data collection exists that will drive
the Nation’s efforts to learn from medical errors.
To inform its
thinking about how such a system should be constructed, the QuIC
reviewed data collection systems that have been designed to support
learning systems in other industries. Successful reporting programs
possess the following common characteristics.
Characteristics
of an Ideal Reporting System for Learning
- The intent
and goal of the reporting system are clear to all interested parties.
- Active leadership
support is ensured at all levels.
- Reports are
accepted from all interested parties.
- Reports are
confidential and identifying information has been removed.
- Reports are
used for prevention, not punishment.
- Reports are
analyzed by technically expert peers, from multiple perspectives.
- Reporting
is easy to do and captures rich detail.
- Reporters
and larger interested communities receive timely feedback.
- Pilot testing
and prototyping of the system takes place before large scale roll-out
occurs.
Currently, several
databases exist that collect information on specific types or errors,
such as CDC’s hospital acquired infections reporting systems, FDA’s
adverse drug and device event reporting systems, and the JCAHO’s
sentinel event system. Others exist that collect information on
errors that occur in a particular health care system, such as VA’s
error reporting system. As previously mentioned, some States have
data collection systems for the facilities within their boundaries.
The QuIC believes
that the fastest way to create a useful and analyzable data set
would be to integrate the data from these existing databases and
from any others that exist. AHRQ has experience in creating such
harmony from disparate data collections. Within its Healthcare
Cost and Utilization Project (HCUP), AHRQ currently employs
cooperative agreements with 22 States to ensure the collection of
a core set of administrative data from hospital discharges that
are then aggregated. These data are then made available for research
and analysis, in a way that protects patient and provider identities.
The QuIC proposes that a similar method should be used to create
an errors database that can be used to provide important insights
into the causes and effective methods for prevention of errors.
AHRQ will lead an effort to gather information from those who run
the existing error data-collection systems, including the Federal,
State and private-sector systems. This evaluation of existing systems
will be used to determine whether they can be aggregated into a
single database.
The aviation
reporting system, which the IOM and others have suggested as a model
that health care should emulate, depends on the collection of as
much information as possible about close calls (which are sometimes
called near misses) as well as errors that actually resulted in
harm. To encourage people to report errors and speed the availability
of information, the aviation system protects the identity of those
who report and those who are involved in the incident. The QuIC
will encourage States and others to include sufficient protections
on the information to ensure that providers will report errors.
This issue is discussed more fully in the section on Peer
Review Protections.
A common set
of core measures is necessary to integrate a broad array of data
collected through different reporting systems. The Quality Forum
can ably undertake the creation of a common set of core measures
for a national errors database. The QuIC agencies would support
such an effort by the Quality Forum or other appropriate private-sector
body.
Patients can
reveal information about their care experiences, including errors
that occurred during their care, that are not otherwise available.
Systems will also be created that will enable patients to report
errors and adverse events, using a standard reporting format that
will complement the error reporting and collection activities of
health care professionals and facilities. To collect such data,
the QuIC will design a Web-based error reporting mechanism.
Within six months,
HCFA, working with a Peer Review Organization (PRO) program, will
develop a pilot study of a confidential, penalty-free learning system
with several hospitals on a voluntary basis.
First, the PRO
will assemble routine hospital error reports to create a highly
confidential database of documented errors occurring in the participating
hospitals. This database would include both near misses and actual
patient harm. The PRO will use the standard taxonomy of medical
errors adopted by the Quality Forum, and use the collected data
for education and technical assistance, not for punitive actions.
This is consistent with the educational strategy that PROs have
adopted over the past decade.
Second, the
PRO will provide support for provider and practitioner error reduction
programs through participating in local root cause analysis of near
misses as well as the episodic serious adverse events, to identify
patterns of medical errors. The PRO will feed back and interpret
information from the database, convene workgroups of interested
and expert parties, and facilitate the exchange of best practices
that could be shared between participating hospitals. The PRO will
also provide the data, with all identifiers removed, to AHRQ, HCFA,
and other partners and investigators. With this information, the
PRO will work with hospitals and practitioners on systems interventions
to reduce medical errors.
Beginning this
spring, the Department of Defense will implement a new reporting
system in its 500 hospitals and clinics, which serve approximately
8 million patients. This reporting system will be modeled on the
system in operation at the Department of Veterans Affairs and will
be used to provide health care professionals and facilities with
the information necessary to protect patient safety. This system
will begin to be pilot tested in August of 2000, will collect information
on adverse events, medication errors, close calls, and other patient
safety issues. Under this system, patients or their families are
notified when a serious medical mistake has been made.
The VA currently
operates a mandatory reporting system. By the end of the year, the
VA will implement a voluntary reporting system for both adverse
events and close calls nationwide. Information will be collected
by an independent external entity, analyzed, and disseminated to
all VA health care networks to help prevent medical errors before
they occur. Implementing this system is likely to lead to a richer
database of information, as incidents are reported on a de-identified
basis, and will allow researchers to compare the effectiveness of
identified systems to de-identified ones.
While the aggregate
database is being created, Federal agencies, such as the VA, CDC,
and FDA will continue to examine their own data for critical information
on why errors occur and how to avoid them. This information will
continue to be communicated to appropriate health care organizations,
manufacturers, and others who need to act on it. Once the database
has been created, AHRQ will lead Federal efforts to expand both
the knowledge of errors and communication with providers and others
who can act on this information. Both information about methods
shown to be effective in reducing errors and particular hazards
will be communicated to providers.
The information
about what methods have been shown to be effective in reducing errors
will also be shared with organizations that have health care oversight
or purchasing responsibilities, so that they can choose to incorporate
them into their efforts to ensure accountability as appropriate.
This forms a natural link between the learning systems and the accountability
systems for error reduction. Health care provider organizations
can be held responsible for adopting methods shown to be effective
in reducing errors, and the public should be given information that
demonstrates such initiatives are in place and are effective.
Actions
- The new Center
for Quality Improvement and Patient Safety (CQuIPS) at AHRQ will
identify existing State and Federal reporting systems (both mandatory
and voluntary), evaluate their suitability in helping to build
a national system of errors reporting, and evaluate how their
data collection or enforcement efforts can be enhanced to improve
the value of those systems.
- QuIC will
work with the Quality Forum to develop reporting criteria that
assure that information can be pooled and shared as needed across
organizations.
- CQuIPS, working
with the QuIC, will describe and disseminate information on characteristics
of existing voluntary reporting programs associated with successful
error reduction and patient safety improvement efforts. FDA, CDC,
and NASA will provide expertise in the development of these nonpunitive
systems.
- Within six
months, HCFA, working with a Peer Review Organization (PRO) program,
will develop a pilot of a confidential, penalty-free learning
system with several hospitals on a voluntary basis.
- Federal agencies,
including the FDA, VA, DoD, CDC, HCFA, and AHRQ, will integrate
data from different sources and conduct and support analysis to
identify error prone procedures, products, and systems.
- By August
2000, the DoD will complete development of a patient safety improvement
program based on a reporting system modeled on that of the VA.
- VA will establish
a voluntary reporting system to supplement its existing mandatory
system.
- AHRQ, in
collaboration with other Federal agencies, will investigate, develop
and test strategies to provide effective feedback to clinicians
and institutions on methods for improving patient safety.
- Federal agencies
will assist health care providers to develop the skills necessary
for analyzing adverse events and near misses (e.g., root cause
analysis, trending, search tools). Federal agencies providing
health care will develop internal systems to 1) identify and report
errors to clinicians and other decision makers, and 2) learn from
those errors and near misses to prevent future events.
- Outreach
to Stakeholders: QuIC will develop programs to foster the dissemination
of research findings to end users through activities such as AHRQ’s
User Liaison Program; provide support to the Quality Forum to
increase the national discussion on errors, their reduction, and
standardized measures of errors; and fund collaborative agreements
with health care professional organizations that foster education,
track patient safety initiatives, provide input to the new patient
safety research centers, and translate, disseminate, and promote
adoption of research findings.
- Patient Safety
Clearinghouse: AHRQ will develop a clearinghouse in partnership
with other Federal agencies and private-sector organizations to
provide an objective source of state-of-the art information on
patient safety.
- AHRQ will
initiate a "National Morbidity & Mortality Conference"
posting selected cases (stripped of identifying information) in
a public forum via Internet technology, and establish a Web site
where patients can report incidents that will be analyzed to identify
emerging problems.
Analysis
and Feedback
On pages 85
and 86, the IOM report summarizes two important points: 1) caution
must be exercised when calculating rates from any type of adverse
event reporting system; and 2) the goal of reporting systems is
not to count the number of reports.
Successful error
reporting systems are analysis and feedback systems. The key to
their success starts with a highly visible ability to properly analyze
cases and recommend changes to those who are empowered to implement
them. Experts in the field of patient safety report that understanding
the "root" of the problem and the "contributing"
factors are winning strategies; counting errors and comparing performance
are not.
Feedback to
key decision makers and those who report is the second part of all
successful error reporting systems. The CDC and FDA have found that
lack of feedback was one of two main reasons for failed "mandatory"
systems. Other activities contributing to success include: 1) training
for those with reporting responsibilities; and 2) free software
and generic data to aid internal analysis.
Experience with
other reporting systems for improving safety demonstrates the importance
of closing the feedback loop. Timely and usable feedback is crucial
in making the system useful to those who report. Therefore, reporting
formats should include both free-text narrative and standardized
information as well as indicate how those who report can use the
feedback.
Peer Review
Protections
IOM Recommendation
Congress should
pass legislation to extend peer review protections to data related
to patient safety and quality improvement that are collected and
analyzed by health care organizations for internal use or shared
with others solely for purposes of improving safety and quality.
QuIC Response
As noted throughout
the IOM report, solutions unique to one individual are essentially
irrelevant. It is the system-wide, generalizable approach that is
the cornerstone to success. The question "Who did it?"
is not important. However, it is critical to find out what happened,
why it happened, and how it can be prevented in the future.
Basic tenets
of a successful reporting system are that those who report must
feel safe in doing so and that their confidentiality must be protected.
Reporting systems in which these factors are missing are generally
unsuccessful in obtaining data, inaccurate, and incomplete. The
experience of the aviation industry speaks to the importance of
a confidential, blame-free reporting environment. The FAA and others
have found major increases in reporting by removing the identity
of the institution submitting the report.
On January 14,
2000, President Clinton acknowledged these characteristics of successful
safety reporting systems when he announced a program that will provide
immunity from punishment to airlines’ personnel when they report
to the FAA operational and procedural errors that threaten passenger
safety. The program’s goal, much like that of patient safety systems,
is to identify trends early and address them before they cause harm
or injury.
The program
is committed to providing appropriate protections for data in the
system, but the protections will depend on the nature of the data
and reporting systems. Such statutory protections already exist
in the Medicare program for mandatory reporting to the program’s
Peer Review Organizations (except when used in criminal investigations).
These protections should be extended to protect voluntary reporting
to achieve the greatest level of learning. The specific details
of the appropriate legal protections must be negotiated with Congress,
the industry, and States.
Previous discussion
has focused on developing reporting systems for learning that deal
with system-wide, rather than individual, performance issues. It
is important to understand that individual performance issues are
best addressed through credentialing, licensing, and other administrative
mechanisms. The QuIC expects that will continue to be the case.
However, it is important to note that safety reporting systems should
never become a shield from necessary actions to address criminal
activity or deliberately unsafe acts. The obligation to report these
activities still exists, and mechanisms to address those issues
should be maintained. For example, the Health Resources and Services
Administration (HRSA)-sponsored National Practitioner Data Bank
records disciplinary actions taken against providers. It is maintained,
in part, to help institutions carry out their responsibility for
patient safety by searching for and reviewing records of applicants
who are seeking staff appointments.
Actions
- The QuIC
supports the extension of peer review protections to facilitate
reporting of errors in a blame-free environment, and will propose
considerations of confidentiality that will not undermine current
mechanisms to address criminal activity or negligence.
- As part the
development of the national reporting system, appropriate electronic
protections (i.e., firewalls and encryption) will be constructed
to ensure that the confidentiality of the patients involved and
the clinician or institution providing the information is maintained,
and that the information gathered will not be used for punitive
purposes. Experience with reporting systems in other industries
demonstrates that this approach encourages reporting of errors.
Setting
Performance Standards and Expectations for Safety
Raising the
Standards for Health Care Organizations
IOM Recommendation
Performance
standards and expectations for health care organizations should
focus greater attention on patient safety.
- Regulators
and accreditors should require health care organizations to implement
meaningful patient safety programs with defined executive responsibility.
- Public and
private purchasers should provide incentives to health care organizations
to demonstrate continuous improvement in patient safety.
QuIC Response
Several QuIC
member organizations are involved with regulation and accreditation.
Some are also health care purchasers. A major purchaser of health
care, HCFA, intends to require hospitals in the Medicare program
to have an effective internal error reporting system and an effective
evidence-based error reduction program for all patients as necessary
components for certification and accreditation. The State survey
agencies, acting as HCFA’s contractors, and the hospital accreditation
organizations, will monitor whether activities to reduce medical
errors are occurring in Medicare participating hospitals. Enforcement
actions will be taken only if such activities are not occurring.
HCFA will conduct research and pilot studies or demonstrations in
nursing homes, where experience with error measurement is more limited
but the need may be equally great.
The current
Conditions of Participation (CoP) for hospitals participating in
Medicare require that the hospitals meet State laws, which includes
error reduction systems. Thus, Medicare rules support existing State
requirements for confidential reporting, whether voluntary or mandatory.
The Health Care
Financing Administration will publish regulations this year requiring
the over 6,000 hospitals participating in the Medicare program to
have ongoing medical error reduction programs that would include,
among other interventions, mechanisms to reduce medication errors.
In order to comply with this new regulation, hospitals may choose
to implement automated pharmacy order entry systems, include automatic
safeguards against harmful drug interactions and other adverse side
effects built into the treatment process, or institute decision-support
systems.
Purchasers,
both public and private, have leverage to stress the importance
of a safe environment in which to deliver patient care. This leverage
must put a premium on medical error reduction through identification,
systems approaches to resolution, and assessment of overall effectiveness.
Both through its own purchasing power and by working closely with
private purchasers, HCFA will institute financial and burden-reduction
incentives to move providers to create a safer health care environment.
In addition, HCFA, as a purchaser, will work with and support accreditation
organizations’ efforts to set standards for patient safety, to measure
and report results, and to use these standards in their purchasing
decisions. The Office of Personnel Management (OPM) will require
that all plans with which it contracts be accredited by organizations
that include evaluation of patient safety programs in their accreditation
process.
Actions
- HCFA will
use its power as a purchaser and regulator to promote the use
of effective error-reduction initiatives in the health care institutions
with which it deals.
- HCFA will
publish regulations this year requiring hospitals participating
in the Medicare Program to ongoing medical error reduction programs.
- OPM will
follow the lead of selected private purchasers to raise the standard
for participation by requiring that all health plans with which
it contracts seek accreditation from an independent, national
accrediting organization that includes evaluation of patient safety
and programs to reduce errors in health care.
- In its call
letter for the 2001 contract year, OPM will ask health plans to
encourage their preferred hospitals to use automated prescription
systems and other integrated data systems. OPM will encourage
health plans to annotate PPO directories to indicate which hospitals
and physicians’ offices use such automated programs.
Raising the
Standards for Health Care Professionals
IOM Recommendation
Performance
standards and expectations for health professionals should focus
greater attention on patient safety.
- Health professional
licensing bodies should:
Implement
periodic re-examination and relicensing of doctors, nurses, and
other key providers, based on both competence and knowledge of
safety practices.
Work with certifying and credentialing organizations to
develop more effective methods to identify unsafe providers and
take action.
- Professional
societies should make visible commitment to patient safety by
establishing a permanent committee dedicated to safety improvement.
This committee should:
Develop
a curriculum on patient safety and encourage its adoption into
training and certification requirements
Disseminate on a regular basis information on patient safety
to members through special sessions at annual conferences, journal
articles and editorials, newsletters, publications, and Web sites.
QuIC Response
The QuIC proposes
that the Federal Government take a lead role in fostering patient
safety efforts through a concerted program in support of error reduction
and improved safety. HRSA, HCFA, VA, DoD, OPM, and all other Federal
agencies that provide or sponsor health services will collaborate
in a five-part program to foster a reduction of medical errors and
to promote health care quality This program will include:
- Programs
that directly impact health care quality in the community: HRSA,
HCFA, OPM, and VA, with other appropriate agencies will foster
community and professional programs that increase quality of health
care (such as DQIP, the recently developed Diabetes Quality Improvement
Project) and decrease errors (for example, pharmacy prescription
surveillance programs). HRSA will use the Area Health Education
Center (AHEC) Program and other programs that affect continuing
professional education in the community to increase such error
reduction and quality promotion programs.
- Quality Infrastructure
Development: Agencies such as DoD and VA, together with other
agencies as appropriate, will develop studies and tools for error
detection and reduction. These tools will reflect both internal
experience as well as other scientific and evidence-based information.
- Health Professionals
Education and Training: HRSA, HCFA, and other Government agencies
will foster development of courses and training materials that
promote error reduction and patient safety by providing incentives
through grants and contracts for the development of new curricula
in health care quality and error reduction methodologies. These
will explore clinical training programs that could incorporate
the simulation models tested by VA, DoD, and others to reduce
error in clinical training programs and the use of CDC’s Epidemic
Intelligence Services (EIS) as a model.
- Licensing
and Certification: The QuIC will convene a meeting of accrediting,
licensing, and certifying bodies to propose, investigate, and
evaluate educational methods to improve analysis, understanding,
and prevention of medical errors. This will also include collaboration
with the Federation of State Medical Boards and others to encourage
education in these areas as a component of relicensing. HRSA,
in coordination with State governments and other agencies involved
with licensing and certification bodies, will assist licensing
bodies to assure continuing competence among practitioners and
to take appropriate actions to protect against unsafe providers.
This will include provision for error-prevention education as
part of the relicensure process.
- Technical
Assistance: The QuIC will provide technical assistance to State
or professional agencies seeking to ensure a basic level of knowledge
for health care providers on patient safety issues, promote model
patient safety programs that include evidence based best patient
safety practices to provider organizations, or help agencies implement
the cultural change necessary to make reporting systems a success.
Priority components
of such a four-part program include community quality measures,
infrastructure development, health professional training, and licensing
and certification measures. These programs will be carried out cooperatively
by involved public- and private-sector institutions.
Actions
The QuIC will:
- Develop and
evaluate programs introducing health professionals to errors analysis
and the challenges of practicing in a technically complex environment,
explore the use and testing of simulators and automation as education
tools, support training in errors research and evaluation, and
develop patient safety expertise at the State level using the
CDC’s Epidemic Intelligence Service as a model.
- Convene a
meeting of the accrediting, licensing, and certifying bodies of
the health professions to review information on medical errors
in the context of current practice requirements and propose methods
of strengthening health professions’ education in the areas of
medical error prevention and medical error evaluation as a means
of improving patient safety.
- Collaborate
with the Federation of State Medical Boards and other entities
to encourage that error reduction and prevention education be
a provision for relicensing of health professionals.
- Collaborate
in the planning, implementation, and evaluation of a national
summit addressing patient safety and medical error reduction programs,
and in producing directives for the future.
- Provide training
within the QuIC agencies that provide care to encourage use of
patient safety information and encourage enhanced reporting in
partnership with private-sector accreditors, purchasers, and providers.
- Provide technical
assistance to State or professional agencies seeking to ensure
a basic level of knowledge for health care providers on patient
safety issues.
Safe Use
of Drugs and Devices
IOM Recommendation
The Food and
Drug Administration (FDA) should increase attention to the safe
use of drugs in both pre- and postmarketing processes through the
following actions:
- Develop and
enforce standards for the design of drug packaging and labeling
that will maximize safe use.
- Require pharmaceutical
companies to test (using FDA-approved methods) proposed drug names
to identify and remedy potential sound-alike and look-alike confusion
with existing drug names.
- Work with
physicians, pharmacists, consumers, and others to establish appropriate
responses to problems identified through postmarketing surveillance,
especially for concerns that are perceived to require immediate
response to protect the safety of patients.
QuIC Response
The FDA works
to ensure the safety and effectiveness of medical products, including
drugs, medical devices, and biological products such as human blood.
In May 1999 the FDA published a report, Managing the Risks from
Medical Product Use, that evaluated its role in medical safety
and discussed options for further improvements. The report emphasized
the systems nature of medical safety and the role of the many stakeholders
in the safety chain.
FDA is responsible,
in conjunction with Institutional Review Boards, for oversight of
patient and volunteer safety in clinical trials of investigational
medical products. To this end, FDA reviews clinical protocols conducted
under Investigational New Drug Applications and Investigational
Device Applications, monitors the adverse events occurring in trialsreporting
adverse events is mandatory for investigators and trial sponsorsand
requires modification or cessation of trials when patient safety
is an issue.
FDA has promulgated
extensive safety criteria that medical products must meet prior
to marketing. Drug, devices, and biological products must undergo
laboratory and clinical testing and meet safety standards before
approval. In addition to toxicological and human safety testing,
these criteria include design controls and human factors testing
for medical devices, and requirements for naming, packaging, and
labeling pharmaceuticals. Strengthening criteria aimed at reducing
name confusion, dosage errors, and device misuse, or improving comprehension
of the product information, would reduce product-related errors.
Improving product safety requirements will require additional research
and collaboration with health care delivery systems, health care
professionals, Government agencies, and manufacturers. Additional
work could be done to implement human factors testing in the evaluation
of medical devices, and to institute such testing for pharmaceuticals.
Threats to patient
safety from medical products can arise from unsafe products or from
unsafe use of medical products. Despite extensive premarket safety
evaluation, unanticipated errors do occur as medical products are
used in the health care system. Although FDA is extensively involved
in the detection and prevention of such errors, many more steps
can be taken to increase the safe use of these products. For example,
FDA has completed Phase I of implementing the Congressionally mandated
Medical Product Surveillance Network (MedSuN), an active reporting
network. FDA now wants to implement a large-scale Phase II study
that will allow the dissemination of data regarding emerging device
problems to health care professionals and the public.
Although FDA
engages in numerous outreach efforts, more safety information, in
a more useful form, needs to be provided to users of medical products.
Similar opportunities for increased efforts exist in the areas of
risk detection, data analysis, risk management, and risk communication.
The FDA, as outlined in the action items below, will take steps
to increase its capacity to detect errors, investigate and understand
them, and prevent further occurrences. The knowledge gained in these
investigations can also be incorporated into premarket review activities,
thus preventing repetition of errors with new medical products.
Actions
Within 1 year,
the FDA will initiate programs to:
- Develop additional
standards for proprietary drug names to avoid name confusion.
- Develop standards
for packaging to prevent dosing and drug mix-ups.
- Develop new
label standards for drugs, highlight drug–drug interactions, potential
dosing errors, and address other common errors related to medications.
- Implement
the Phase II pilot study of the Congressionally mandated Medical
Product Surveillance Network (MedSUN).
- Intensify
efforts to ensure manufacturers’ compliance with FDA programs,
specifically naming, labeling, and packaging.
- Provide access
to databases linked to health care systems and other sources of
adverse-event and marketing data, and link these to existing registries
of product users.
- Complete
the on-line Adverse Event Reporting Systems (AERS) for drugs and
biologics.
- Strengthen
FDA's analytical and investigative capacities.
- Strengthen
FDA outreach activities and collaboration with other Government
agencies and stakeholders.
Implementing
Safety Systems in Health Care Organizations
IOM Recommendations
Health care
organizations and the professionals affiliated with them should
make continual improvement in patient safety a declared and serious
aim by establishing patient safety programs with defined executive
responsibility. Patient safety programs should:
- Provide strong,
clear, and visible attention to safety.
- Implement
nonpunitive systems for reporting and analyzing errors within
their organizations.
- Incorporate
well-understood safety principles, such as standardization and
simplification of equipment, supplies, and processes.
- Establish
interdisciplinary team-training programs for providers that incorporate
proven methods of team training, such as simulation.
Health care
institutions should implement proven medication safety practices.
QuIC Response
Extensive "hands-on"
communication is critical in building trust in the population from
whom reports are expected. Systems perceived as punitive or exposing
individuals or institutions to legal liability have proven to be
much less effective than desired. For example, JCAHO has experienced
significant difficulty in securing hospitals’ participation in its
"sentinel events" reporting system because of worries
surrounding legal vulnerabilities or punitive actions.
Another factor
influencing the success of safety programs is the level at which
organizational responsibility is established. Experts suggest that
safety programs within individual organizations or institutions
are most effective when reporting is at the level of the chief executive
officer. Responsibility and reporting at the level of the CEO makes
the issue of organizational accountability clear. It ensures that
patient safety has the attention of the highest levels of the organization.
It sends a clear message throughout the organization that safety
is a priority, and it helps remove the inherent conflicts of interest
that may occur if the reporting occurs at lower levels.
Several Federal
agencies have already undertaken the task of creating meaningful
patient safety systems within their health care delivery organizations.
VA has an exemplary patient safety program, and the DoD is developing
one that is modeled after that of VA. The National Institutes of
Health’s Clinical Center has a long standing "Occurrence Reporting
System" to report unanticipated patient care events. Further
refinements of each system will be made.
This summer,
the QuIC will be working with the Institute for Healthcare Improvement
(IHI) to create an initiative that will test several strategies
for rapidly reducing the number of errors committed. Our effort
will be targeted specifically at health care delivery settings where
patients are in need of urgent assistance and decisions have to
be made rapidly, which we are calling "high-hazard environments."
These would include emergency departments, operating rooms, intensive
care units, and on-site rescue operations. This is the first such
initiative targeted at error reduction in these high hazard environments.
Based on the results of previous IHI initiatives, it is hoped that
some sites will be able to achieve reductions of 25–30 percent in
the number of errors within 12 to 15 months. The findings from this
Federal effort will be shared broadly to help other organizations
reduce errors in their own health care delivery settings.
Information
technology offers other opportunities for the reduction of medical
errors and is discussed in Chapter
3.
Actions
- Under the
leadership of the CQuIPS, the QuIC will promote, at the executive
level, the development and dissemination of evidence-based, best
patient-safety practices to provider organizations.
- QuIC participants,
including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities
with private-sector accreditation, purchaser, and provider organizations
to develop organization-based, patient-safety models that could
be evaluated, and if found effective, disseminated widely. In
addition, these stakeholders will be engaged in a regular dialogue
with QuIC participants to ensure that the stakeholders’organizational
needs are being met through Federal research and reporting initiatives.
- Through its
exemplary patient safety program, VA will continue to scrutinize
its care provision for opportunities to improve safety, and develop
and expand its reporting system.
- VA will invest
$47.6 million this year to increase patient safety training for
staff (details in Chapter 3).
- DoD will
invest $64 million in FY 2001 to begin implementation of a new
computerized medical record system, including an automated order
entry system for pharmaceuticals (details in Chapter
3).
- Other QuIC
direct-care providers will initiate patient safety programs (e.g.,
HRSA’s community health care centers are investigating the most
effective programs that can be implemented in their health care
delivery systems).
- QuIC member
agencies will begin a collaborative project this summer with the
Institute for Healthcare Improvement to reduce errors in high-hazard
health care delivery settings.
Framework
for Reporting Systems
A. Purpose:
Data collected for one purpose are not easily used for another.
B. Reporting:
Need clear definitions, easy mechanisms for reporting, system capable
of using data for intended purpose (1).
- Learning
- Mandatory
- Need
incentive (e.g., return of valuable information) to ensure
reporting.
- Data
need to be protected from discovery.
- Could
include near misses likely to lead to major adverse event.
- Voluntary
- Reporter
must see it in self-interest to report.
- Completeness
of database contingent upon willingness to report.
- Could
include near misses likely to lead to major adverse event.
- Accountability
- Mandatory
- Accountability
aspect could be the review (i.e., audit) of the safety and
error analysis process.
- Many
systems already exist for high interest/high profile adverse
events.
- Works
best for events that are difficult to overlook.
- Voluntary
- Not applicable
because no one would agree that something truly voluntary
is a basis for accountability.
(1)
Any criminal act identified through reporting systems will be handled
with appropriate mechanisms.
Chapter
3. Beyond the IOM Report: Identifying and Implementing Additional
Strategies
While the IOM
report offered many useful recommendations for improving the safety
of the health care system, additional actions can and should be
taken to reduce errors. Federal agencies have been working on a
variety of projects designed to reduce medical errors and, in many
instances, are the national leaders in experimenting with programs
intended to promote safety. A brief description is provided below
of some of the current activities, as well as recommendations for
additional activities to reduce errors through increased awareness
of medical errors; commitment of substantial resources to further
research; the use of information systems; and the redesign of systems,
procedures, and medical products.
Building
Public Awareness of Medical Errors
Well-informed
patients are key participants in the effort to enhance the quality
and safety of American health care. The right question from a patient
at the right time may be the intervention that averts an error.
As the IOM report recognizes, the public largely believes that it
is protected from errors and safety problems. For instance, the
public assumes that licensure and accreditation confer a "Good
Housekeeping Seal of Approval" on practitioners and institutions
(Institute of Medicine, 1999). Thus,
the public assumes that they can implicitly trust those professionals
and facilities to do the right thing in the right way. Despite health
professionals’ best attempts to make patients’ assumptions a reality,
the available evidence about medical errors suggests that reality
falls short. In that respect, patients’ understanding of the medical
errors situation is not substantially different from their understanding
of other confusing aspects of the health care system. For example,
the Employee Benefit Research Institute (EBRI) reports that only
21 percent of managed care participants know they are in this type
of plan. Instituting a national patient safety electronic bulletin
board, as indicated in "Learning
from Errors" in Chapter 2, will not only enable patients
to report errors that they see or experience, but will also aid
in improving the public’s general understanding of patient safety.
Although some
members of the public are aware that the health care environment
itself is less safe than previously assumed, they have made few
demands for improvement of the system. A 1997 survey by the National
Patient Safety Foundation found that many people view errors as
a problem that can be fixed by getting rid of bad providers, rather
than as the consequence of delivering care within a complex delivery
system.
Clearly, an
ongoing, aggressive public information and education effort is needed
to increase all Americans' understanding of both how medical errors
occur and what steps they can take to prevent such errors. This
campaign must carefully address the tension between the need for
increasing general awareness with the competing need of ensuring
that patients are not afraid of receiving necessary care.
The QuIC agencies,
working in close collaboration with private-sector organizations,
can develop consistent patient safety messages and themes that can
be used by Federal agencies and private-sector employers, health
care purchasers, and others to disseminate a powerful and consistent
message to individuals about their role in ensuring the quality
of their own health care. The QuIC has established the Enhancing
Patient and Consumer Information working group with the specific
intent of providing the public with clearer and more consistent
information about health care qualityand patient safety is
a key part of that information. The QuIC agencies see this work
group as a foundation for strengthening the effectiveness of the
actions that agencies might have otherwise taken independently.
In particular,
Federal agencies that provide or purchase health care have a responsibility
to work with their constituencies to increase awareness of patient
safety issues and the role their constituents can play in improving
safety. For instance, part of HCFA’s and OPM’s mission in purchasing
health care is to provide information to enrollees that will help
them choose their health coverage. These agencies are exploring
how to educate enrollees so that they can understand and evaluate
issues related to medical errors and take appropriate actions. HCFA
and OPM also lead the QuIC working group on patient and consumer
information, which provides a natural vehicle for extending the
messages to other Federal beneficiaries and the public.
A number of
other mechanisms exist to extend the work of this work group to
more people. It is possible to use public–private partnerships to
communicate the patient safety message to a variety of audiences
through recently developed mechanisms. These partnerships include
the NPSF, NPSP, and the Quality Forum, and are summarized in the
"Actions" section that follows.
Actions
- Through the
QuIC’s Enhancing Patient and Consumer Information Working Group,
led by OPM and HCFA, Federal agencies will develop and coordinate
an information campaign for their constituencies and beneficiaries
to increase their awareness of the problem of medical errors and
patient safety.
- AHRQ will
develop generic material for the public on preventing medical
errors that Federal agencies can disseminate, reprint, or adapt.
This material will enable patients to become more involved in
their care and to be more active participants in the decisionmaking
surrounding their care.
- The CQuIPS
will develop and test patient safety questions for inclusion in
the patient survey now being developed for provider-level assessment
of health care.
- HCFA will
conduct research aimed at shaping programs to educate beneficiaries
about medical errors.
- Within 1
year, FDA will increase collaborative programs with patient and
consumer groups regarding patient safety.
- FDA will
enhance its interactions with the public through meetings with
consumer and patient organizations, and through grass-roots informational
meetings. The meetings will focus on patient needs and the safe
use of medical products, particularly for home use. The meetings
will also discuss how to reach patients with important information
on safe use of medical productsincluding through the use
of local networks, the Internet, and electronic and print media.
This will occur within 1 year.
- Patient safety
and reducing medical errors will be a featured topic at OPM’s
Fall 2000 annual health plan conference.
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Building
Purchasers’ Awareness of the Problem
Just as with
Federal purchasers of health care, it is critical that employers
who sponsor group health plans understand that quality, not just
cost, is a factor to be considered in selecting health care providers
for their employees. In 1998, the DOL’s Pension and Welfare Benefits
Administration (PWBA) issued a letter making clear that, where the
selection involves the disposition of employee benefit plan assets,
taking quality into account is part of a plan decisionmaker's responsibility
under the Employee Retirement Income Security Act (ERISA).
To assist employers
in meeting this obligation, the DOL launched the Health Benefits
Education Campaign in December 1998. One of the goals of the Campaign,
a coalition of the DOL with both public- and private-sector partners,
is to inform employees about issues of quality and safety under
their employer-provided health benefits so that they can make informed
health benefits decisions. The Campaign further seeks to inform
employers of the value of providing quality and affordable health
benefits to their employees. It provides a forum for sharing with
the private sector the information learned from other QuIC agencies
on quality care, setting and implementing standards, developing
and implementing data integration techniques, and effectively communicating
with consumers.
A number of
employers and employer health care coalitions are already taking
the initiative of making safe medical practice an important criterion
in selecting the health insurance they provide to their workers.
For example, the National Business Coalition on Health (NBCH), a
Campaign partner, is developing a set of standards that employers
can voluntarily use to evaluate safety and quality in health plans.
The Business Roundtable, another Campaign partner, has allocated
funds for the Leapfrog Group, an organization of eight executives
of some of the Nation’s biggest companies and health care purchasers,
including OPM, to encourage all employers to make safety and quality
in health care a top priority. DOL will, through the Campaign, work
with plans, employers, and participants to advance the provision
of safe, high-quality health benefits. Some of the work that is
being done is summarized in the "Actions" section that
follows.
Actions
- Building
on existing relationships with purchasers and business coalitions,
such as the National Business Coalition on Health, and the Washington
(DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM,
and AHRQ will spearhead the QuIC’s efforts to promote collaborative
programs with other public- and private-sector partners to increase
purchasers’ and providers’ awareness of medical errors as a health
care problem and of steps that each can take to address this problem,
such as addressing patients’ health literacy skills.
- At the Federal
Benefits Conference (June 2000), OPM will share information about
patient safety with representatives from Federal agencies throughout
the Nation.
Working
With Providers to Improve Patient Safety
In addition
to information for patients and purchasers, information is needed
for health professionals, facilities, and systems of care to ensure
that they understand the scope of the medical errors problem and
its impact. Results from surveys and focus groups conducted by VA,
involving both VA and private-sector facilities, have shown that
a substantial portion of doctors, nurses, and others working in
health care facilities do not believe that medical errors present
a significant threat to patients. If they believe that medical errors
and issues of patient safety are isolated, random events, efforts
to reduce the current incidence of preventable errors will not be
successful.
The public’s
perception is that the health professional credentialing and institutional
accreditation processes provide meaningful assurances of the quality
of care. It is crucial that professional societies, accrediting
bodies, and licensure organizations use their roles to promote patient
safety by ensuring that those whom they credential and accredit
are knowledgeable about issues of safety and implement procedural
changes that have been shown to reduce the likelihood of error.
Help by these organizations is paramount in fostering awareness
and understanding of issues about medical errors and patient safety.
The QuIC agencies
will work collaboratively with professional societies to promote
awareness of the medical errors problems and to identify ways to
improve the education, credentialing and accrediting processes to
rigorously examine safety knowledge and practices. AHRQ will work
with private-sector groups, such as NPSF, NPSP, and the Quality
Forum to educate providers and purchasers about improving patient
safety.
Actions
- Through the
QuIC, Federal agencies will take advantage of existing resources
to promote collaborative patient safety programs involving agency
constituents, the health professions community, the public, academia,
and other stakeholders, such as the American Medical Association,
the American Nurses Association, NPSF, NPSP, and the Quality Forum.
- VA will develop
and run pilot patient safety education programs for medical residents
and students.
Using Decision-Support
Systems and Information Technologies
The Federal
Government has played a pivotal role in the application of information
technology to health care. The predecessor of AHRQ funded some of
the earliest research on computerized patient records, studies evaluating
the impact of computer reminder systems on laboratory testing errors,
and research on the effect of computers on drug ordering. VA and
DoD are recognized national leaders in the implementation of electronic
medical records and decision-support tools. They have recently joined
in partnership with the Indian Health Service (IHS) to develop a
prototype for a computerized medical record system. In addition,
many private-sector leaders in health care informatics, such as
Intermountain Healthcare and the Brigham and Women’s Hospital, have
used Federal grants to develop and test their systems. The President
has also requested $20 million in the FY 2001 Budget for the Health
Informatics Initiative, which includes support for strategies to
address the problem of medical errors through enhanced information
technology.
Although the
success of health care informatics models is well documented and
their applicability to patient safety is clear, they have not been
widely adopted. A Federal effort to further knowledge about the
application and effectiveness of these technologies to patient safety
improvement and to promote the appropriate adoption of these tools
would build on a strong foundation of prior work and put health
care technologies to use in improving the quality of care for Americans.
One example
of where the QuIC could have an impact through its participants’
activities is in the area of electronic records and order entry.
Most health care providers currently work with handwritten patient
notes, which are often difficult to read, not readily available,
incomplete, and prone to alteration, destruction, and loss. Electronic
medical records and interactive decision-support tools have the
potential to allow health care providers timely knowledge of a patient’s
health history and improve clinical care. Electronic access to a
patient's chart removes uncertainties regarding the patient's health
history. Further, well-designed electronic systems can give physicians,
nurses, and other providers essential access to the most current
results of consultations, laboratory tests, x-rays and other studies,
and to previous test results. Structured, electronic order entry
systems that require complete data entry remove ambiguities that
arise from incomplete information or illegible writing.
Moreover, real-time
decision support constitutes a powerful technology that can help
address the significant problem of medication errors. Decision-support
systems can intercept errors, such as interactions between incompatible
medications and the prescription of drugs to which the patient's
electronic medical record notes an allergy. Patient factors relevant
to the dosing of particular medications can also be evaluated electronically;
drug overdosing or underdosing can be corrected by accounting for
a patient’s age, weight, and kidney function. Taken further, better
choices of medications for a particular condition can be recommended,
such as the most diagnosis-appropriate antibiotic. Finally, bar-coding
of medications and use of robotics in dispensing medications can
ensure that the appropriate medication is provided to the appropriate
patient at the appropriate time.
Health care
organizations can more easily and reliably aggregate their electronic
records to look for trends and provide data for research on patient
safety issues without relying on costly chart reviews. Provider
profiles can be used to provide helpful feedback to clinicians and
to identify needs for training and system changes. Health care organization
profiles can be developed for any level of the organization to look
for systemic problems and evaluate interventions.
However, there
is a real need to involve clinicians and other users in the design
of systems at an early stage to optimize usability. Increased emphasis
on design controls for manufacturers is needed to ensure that usability
testing occurs throughout development, especially in the premarket
design phase of medical device development. Continued development,
taking into account knowledge of human factors and results of usability
testing, is needed. Use of human factors standards, such as nationally
or internationally accepted standards for products and the human
factors standards used by NASA and DoD, could aid in that process.
Information
technology has tremendous potential to reduce errors in health care
by providing information when it is needed, providing clinical feedback,
and alerting providers to potential problems. But, as noted earlier,
information technology also has the potential to cause errors. Therefore,
attention to human factors and other aspects of system design is
vital. Additional research is needed to explore the safety and effectiveness
of, for example, decision-support systems embedded in software and
other technical aspects of medical products.
Actions
- AHRQ and
CDC will expand research efforts in the area of informatics to
include initiatives aimed at developing and evaluating electronic
systems to identify, track, and address patient safety concerns.
- CQuIPS at
AHRQ, along with VA, DoD, FDA and other QuIC member agencies,
will evaluate the effectiveness of automated physician order-entry
systems in hospitals.
- DoD, VA,
and IHS will introduce electronic patient records to offer structured
documentation and a common clinical lexicon for practitioners
working throughout those systems. The QuIC will encourage other
potential Federal participants to do likewise.
Using Standardized
Procedures, Checklists, and the Results of Human Factors Research
Embedding checklists
and standardized procedures in medical devices (as has been done
with anesthesia gas machines) needs to be expanded to many more
medical devices to protect patient safety. The American National
Standards Institute (ANSI) is leading an effort to develop U.S.
national standards for medical device alarms and human factors-based
engineering designs of medical devices. The Association for the
Advancement of Medical Instrumentation is developing human factors
standards for medical devices. The development of standard operating
procedures can also help. For example, the Occupational Safety and
Health Administration’s (OSHA’s) Bloodborne Pathogens Standard requiring
proper disposal of contaminated sharps and needles ensures a safer
environment for both workers and patients. The DHHS Advisory Committee
on Blood Safety and Availability has issued recommendations to prevent
errors and accidents in the collection and administration of blood.
FDA's Quality
Systems Regulation, which governs the design process for medical
devices, provides manufacturers with guidance on human factors design
principles and information on how to conduct a risk assessment to
qualify their design, and serves as a model for other programs.
The internationally recognized expertise in human factors research
of NASA, DoD, and FAA could be applied to the improvement of patient
safety with the establishment of appropriate links to the QuIC participants.
Additionally,
recognizing that many problems are not detected until after a product
has been marketed, FDA believes that strengthening its premarket
activities, including those related to human factors, will aid in
reducing problems that users may encounter with medical products
in clinical use. For example, premarket testing of standardized
procedures for operation and maintenance of products, user instructions,
and labels would aid in detecting and preventing errors associated
with the use of medical products. FDA proposes to encourage manufacturers
to explore human factors issues through the use of premarket focus
groups as well as through user testing of the product in its intended
environment.
Health care
organizations need to develop staff awareness of the need for continuous
improvement of quality, processes, and performance as another critical
component of error reduction. The Federal health care delivery systems
have been providing meaningful quality improvement training to personnel
at their delivery sites for several years. Error reduction has been
a strong focus for some programs, such as those at VA. For example,
quality improvement training led to concentrated potassium chloride
containers being removed from patient care settings. This kind of
information can be shared broadly with other health care providers
to emulate VA’s success.
Actions
- CDC and FDA
will work with the DHHS Advisory Committee on Blood Safety and
Availability to help ensure that the highest quality standards
are met in blood collection and transfusion.
- Within 1
year, FDA will begin working with manufacturers of medical products
to explore incorporating standards, including human factors standards,
into guidance to ensure that medical products are designed to
minimize the chance of errors.
- NASA will
be invited to become a participant in QuIC activities and bring
its understanding and experience in redesigning processes and
procedures to enhance safety. Linkages between NASA and the CQuIPS
will be established through the NASA Medical Policy Board.
- The QuIC
will sponsor an educational program, noted in the section on research
above, to increase the awareness of Federal regulators and policymakers
regarding patient safety, human factors, and systems-based improvement.
- VA will continue
to work with private-sector organizations (e. g., the American
Hospital Association and JCAHO) to explore the utility of its
comprehensive error analysis and corrective action system.
Chapter
4. Working With the Private Sector and State Governments
The agencies
that constitute the QuIC have longstanding relationships with the
private sector, including professional organizations, purchasers
and purchaser coalitions, business groups, independent accrediting
entities, quality measurement and consumer information experts,
researchers, medical product manufacturers, hospitals, group practices,
health systems and health plans. Working collaboratively, the QuIC
agencies can make use of these relationships to help reduce medical
errors and increase patient safety, thereby improving the quality
of care for all Americans.
Federal agencies
working with the private sector can use a systems approach to help
bring a level of organization to the Nation’s systems of health
care. They can:
- Develop,
articulate, and encourage clear lines of accountability through
measures and standards.
- Improve reporting
and identification of errors through data integration.
- Provide clear,
consistent information and educate patients to be more responsible
for their own care and safety.
- Reach out
to others in the health care industry and increase support for
efforts to reduce medical errors and improve patient safety.
Together, Federal
agencies and the private sector can bring patient safety to the
forefront of the national agenda and help the Nation achieve greater
safety and quality in its health care system.
The QuIC member
agencies represent health care purchasers, providers, policymakers,
regulators, researchers, and patient advocates. These agenciesworking
together with their private-sector counterpartscan define,
demand, recognize, and reward quality. Specifically, they can capitalize
on the current consensus for action in the areas of standards and
data integration, improve the knowledge base about errors, learn
from errors, and encourage the dissemination of information on patient
safety to the publicissues that were addressed earlier in
this report.
State government
plays a critical role in a number of patient-safety related activities,
such as the authority for licensure of health care providers. Importantly,
over 20 States have existing mandatory reporting programs related
to patient safety. State and local governments can also have a significant
impact on patient safety in their roles as health care purchasers,
providers, and regulators. These activities could be enhanced by
partnership with both Federal agencies and the private sector. For
example, the collection of protected State reporting datathat
has also been stripped of identifying informationthrough the
coordination of the CQuIPS at AHRQ will provide a national resource
for learning more about the occurrence of errors and developing
strategies to reduce them. The CDC has programs, including the Epidemic
Intelligence Service, that could serve as a model for coordinated
Federal-State efforts to improve patient safety. The Department
of Labor’s PWBA has also developed a valuable collaborative relationship
with the National Association of Insurance Commissioners (NAIC)
and individual State insurance regulators to foster a better understanding
of ERISA's health benefits provisions among the public and the regulated
community. Many of the actions proposed by the QuIC will benefit
from building upon existing Federal-State Government partnerships.
Despite these
encouraging and productive collaborations between the Federal Government’s
agencies involved in health care quality and both the private sector
and State governments, the IOM report emphasizes how much more can
be done to reduce the rate of medical errors and to enhance patient
safety. The QuIC and its member agencies are committed to implementing
additional cooperative and collaborative programs, especially in
the areas of standards and data integration.
Standards
In the health
care industry, standards, broadly defined, are reflected in two
areas: accreditation programs and performance measures (or measurement
sets). Accreditation programs for health plans offer a powerful
vehicle to enhance quality and safety. Such programs not only assess
the structural capacity of organizations to meet critical standards,
but also increasingly incorporate performance measures into the
accreditation process. By working with independent accrediting organizations,
such as JCAHO, the American Accreditation Health Care Commission/URAC,
and the National Committee for Quality Assurance (NCQA), and by
encouraging or requiring accreditation of health plans, QuIC agencies
that purchase or provide health care can raise the bar for quality
across the industry.
The QuIC will
send a clear and consistent message about the desirability of appropriate
measures and standards by encouraging its member agencies to participate
in development efforts, disseminate information, adopt or encourage
adoption of measures and standards related to patient safety, and
require reports and performance improvement, as appropriate. The
QuIC will assure that individual agency efforts are communicated,
coordinated, and cohesive in terms of what is being asked of the
health care industry and its providers. By doing so, the QuIC will
directly impact the quality of care available to Americans.
For example,
under HCFA’s leadership, a group of public- and private-sector partners
developed the DQIP measurement set. The measures were developed
based on research sponsored by QuIC agencies and translated into
performance measures by collaborating Federal agencies. QuIC agencies
have endorsed and will use the DQIP measurement set. Similarly,
NCQA, one of the DQIP partners, has adopted the measurement set
for testing in 2000. The result of these DQIP-related activities
will be better care for Americans with diabetes. QuIC agencies,
in partnership with accreditation organizations and others, will
undertake similar collaborative efforts in other areas to improve
standards and measures related to patient safety and the reduction
of medical errors.
In another effort,
Federal agencies have launched a public-private sector initiative
with over 50 participating organizations or agencies to reduce medication
errors in the outpatient setting. The Study of Clinically Relevant
Indicators for Pharmacologic Therapy (SCRIPT) project will result
in development and field testing of performance measures for medication
management and error reduction in several common and costly diseases
or conditions (diabetes, coronary artery disease, congestive heart
failure, hypertension, hyperlipidemia, and atrial fibrillation)
and should be completed this year.
Few health care
purchasers, either private or Federal, deal directly with providers.
However, purchasers can encourage their health plans to endorse
and facilitate sound provider practices. They can require that health
plans encourage their networks to implement accountability systems
and ensure that sound practices are noted and rewarded. For instance,
Federal agencies, such as HCFA, that contract with health plans
will provide oversight of health plan arrangements for hospital
and practitioner services to help create a patient-safe hospital
environment (i.e., requirements for medical error reduction systems,
including approaches to producing appropriate results over a specified
period of time). In addition, health plans can encourage their network
providers to participate in nonpunitive error reporting that facilitates
the identification and correction of systemic problems. Health plans
can make a major contribution to patient safety and quality of care
in response to clearly articulated and achievable purchaser expectations.
Federal agencies
also can work with other health care purchasers to support the development
and implementation of provider-level programs for accrediting organizations
and encourage the incorporation of more rigorous safety standards
into existing programs. While much good work has already been completed,
much more needs to be done to establish and enforce adequate credentialing
standards for physicians, hospitals, and preferred provider organizations.
Under the auspices of the QuIC, VA is leading an effort to identify
a core set of credentialing elements across different agencies and
departments. This effort will establish a model for interorganizational
collaboration that the private sector may choose to adopt. As part
of its research effort on medical errors, the QuIC will collaborate
with certifying boards for health care professionals to develop
measures of patient safety appropriate for inclusion in certification
and recertification programs.
As mentioned
earlier, the health care industry has much to learn from other industries
that have more impressive safety records. The CQuIPS in AHRQ will
identify successful safety programs, assessing the evidence that
they are, indeed, "best practices," and sharing information
on their techniques and their adaptability to health care. QuIC
agencies can use their influence to incorporate those strategies
and encourage private-sector purchasers to do likewise. For example,
there is considerable potential for error reduction through the
use of automated systems to enter and process prescription orders
and to monitor for risks of adverse drug events. The use of and
advocacy for such systems by Federal purchasers and providers could
accelerate their use. Similarly, Federal agencies could create demand
for the use of electronic prescription ordering systems at physicians’
offices by encouraging their colleagues in the pharmaceutical industry,
including pharmacy benefits managers and others, to support and
facilitate the use of such systems by health care providers. Adherence
to recommended protocols (e.g., beta-blockers following heart attack)
is another aspect of care that can be monitored to reduce errors.
QuIC agencies and their partners should institute programs of quality
assurance and quality improvement focused on error reduction.
Finally, Federal
agencies have been involved in the creation of performance standards
used in development of medical products for many years. The FDA
plays a central role in collaborating with the private sector by
helping to develop industry standards for medical products. For
example, FDA works with representatives from the medical industry,
health and technical professionals, and consumer and patient organizations
to identify and develop new standards for medical products that
use emerging and complex technologies. In addition, the QuIC recommends
that Federal agencies should, in partnership with the Quality Forum,
establish a consortium of private-sector organizations, industry
representatives, academic institutions, and scientific and health
care professionals to examine issues related to medical product
standards, such as addressing human factors early in the development
of new medical products.
Actions
- The QuIC
and its member agencies will ask independent accrediting organizations
to demonstrate how they are coordinating and strengthening their
patient safety standards.
- AHRQ’s CQuIPS,
through the research agenda articulated above, will develop evidence-based
measures that integrate human factors and lessons from other industries.
- As with the
DQIP measurement set, the QuIC will solicit formal adoption and
use by member agencies of common, validated, and standardized
performance measures in the area of error reduction. The QuIC
will work with certifying boards for health care professionals
to incorporate these measures into certification and recertification
programs where appropriate.
- QuIC agencies
will encourage their private-sector partner organizations to support
the implementation of more rigorous safety standards and will
act to facilitate the ability of private-sector partners to do
so.
- The QuIC
will work through the Quality Forum, the NPSF, and the NPSP to
collaborate with private-sector organizations, industry representatives,
academic institutions, and scientific and health care professionals
to examine issues related to standards, to test standards of performance
measurement, and to establish a set of core standards.
- DOL will
build on an existing collaboration with the National Association
of Insurance Commissioners to exchange information between DOL,
the States, employers, plans, and individual patients on medical
errors and safe, high-quality health care.
- OPM will
participate with private-sector organizations in the development
of standards and measures, share QuIC-adopted standards and measures
with its health plans, and advocate the use of such standards
and measures throughout plan networks.
- OPM will
also begin collecting performance measurement data from its participating
plans and will make performance information available to beneficiaries
of the Federal Employees Health Benefits Program.
- Patient safety
and reducing medical errors will be a featured topic at OPM’s
Fall 2000 annual health plan conference.
Data Integration
At present,
the challenge of improving patient safety with an inadequate evidence
base is compounded by the fragmentation of information regarding
errors. The QuIC can play an important role in bringing together
information from disparate sources to create comprehensive information
resources that could further the development of research and practice
related to patient safety. For example, FDA could use the databases
developed by pharmaceutical benefits managers to learn about frequent
errors and near misses. QuIC members can play an important role
by insisting on data integration among providers such as pharmacy
benefits managers, physicians, hospitals, and laboratories.
The CQuIPS,
working with the QuIC and its member agencies (e.g., CDC, DoD, FDA,
OPM, VA), State and local governments, providers, and health plans,
should develop and maintain a national program to collect information
abstracted from reports on errors and incidents, to share the lessons
learned from these error-reporting systems, and to promote action
to reduce errors and near misses. AHRQ's existing Healthcare Cost
and Utilization Project (HCUP) provides a relevant model for this
task. HCUP pools hospital discharge data (that has been stripped
of identifying patient information) from the States, and integrates
that data into a single resource for researchers and decisionmakers.
The HCUP database thus provides an opportunity for States to compare
themselves to other States. The CDC also has relevant experience
in integrating data from the States for learning purposes that will
help guide this effort.
An additional
opportunity for QuIC agencies (especially HCFA, FDA, and AHRQ) to
work together through data integration would be provided by the
development of an expanded drug benefit program for Medicare beneficiaries.
Combining data stripped of patient identifiers from the PBMs (pharmaceutical
benefits managers) into a single resource could provide a valuable
tool for enhancing patient safety. This could build on work being
done by AHRQ’s CERTs and the work of the FDA, as well as on models
already being used by VA and DoD. Through collaborations with the
private sector, the QuIC agencies could develop a plan for reducing
medication errors in an expanded Medicare drug benefit program.
OPM can also use its relationship with health plans and preferred
provider organizations to encourage the adoption of data integration
by those providers as well.
This effort,
as envisioned by the IOM, requires that a coordinated set of core
information on errors be collected across all of the participating
reporting systems. The IOM suggested that the Quality Forum be given
the task of identifying that core set of information. Given the
mission of the Quality Forum and its existence as a public-private
partnership, the QuIC believes that this recommendation is entirely
appropriate, and QuIC agencies are committed to working with the
Quality Forum on the development of this set of data requirements.
Methods for integrating, analyzing, and disseminating patient safety
data will also be developed as part of the National Healthcare Quality
Report effort being led by AHRQ and the CDC.
Actions
- The QuIC
members will work with and support the Quality Forum in its identification
of a core set of errors reporting data.
- AHRQ, working
with its QuIC partners, will identify existing data sets (such
as the State mandatory errors reporting data) that can be brought
together to enhance the Nation’s knowledge and understanding of
errors. Based upon experience with the HCUP and the CDC’s data
integration efforts, AHRQ will work with those entities that have
the data to determine the feasibility of pooling the data and
using this resource to learn about opportunities to reduce errors
and enhance patient safety.
- OPM will
discuss with health plans and preferred provider organizations
the development of strategies for focusing disease management
programs and integrated data systems on the goal of avoiding medical
errors and improving patient outcomes.
- HCFA, in
collaboration with FDA and AHRQ, will develop a strategy for incorporating
initiatives to increase patient safety into the pharmaceutical
benefits managers program under an expanded Medicare drug benefit.
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Glossary
Organization
and Acronym Guide
Agency for Health
Care Policy and ResearchAHCPR
Agency for Healthcare Research and QualityAHRQ
American National Standards InstituteANSI
Area Health Education Center ProgramAHEC
American Hospital AssociationAHA
American Medical AssociationAMA
American Nurses AssociationANA
Association for the Advancement of Medical InstrumentationAAMI
Aviation Safety Reporting SystemASRS
Centers for
Disease Control and PreventionCDC
Centers for Education and Research on TherapeuticsCERTs
Center for Quality Improvement and Patient SafetyCQuIPS
Conditions of ParticipationCoP
Department of
DefenseDoD
Department of Health and Human ServicesDHHS
Department of LaborDOL
Department of Veterans AffairsVA
Diabetes Quality Improvement ProjectDQIP
Employee Benefit
Research InstituteEBRI
Employee Retirement Income Security ActERISA
Epidemic Intelligence ServiceEIS
Federal Aviation
Administration FAA
Federation of State Medical Boards FSMB
Fiscal YearFY
Food and Drug AdministrationFDA
Health Benefits
Education Campaign
Healthcare Cost and Utilization ProjectHCUP
Health Care Financing AdministrationHCFA
Health Resources and Services AdministrationHRSA
Indian Health
ServiceIHS
Institute of MedicineIOM
Intensive care unitICU
Joint Commission
on Accreditation of Healthcare OrganizationsJCAHO
National Aeronautics
and Space AdministrationNASA
National Association of Insurance CommissionersNAIC
National Business Coalition on HealthNBCH
National Committee for Quality AssuranceNCQA
National Coordinating Council for Medication Error Reporting and
PreventionNCCMERP
The National Forum for Health Care Quality Measurement and Reporting
Quality Forum
National Health Care SurveyNHCS
National Nosocomial Infections SurveillanceNNIS
National Patient Safety FoundationNPSF
National Patient Safety PartnershipNPSP
National Practitioner Data BankNPDB
Occupational
Safety and Health AdministrationOSHA
Office of Personnel ManagementOPM
Operating roomOR
Pension and
Welfare Benefits AdministrationPWBA
Quality Assessment/Performance
ImprovementQAPI
Quality Interagency Coordination Task ForceQuIC
Study of Clinically
Relevant Indicators for Pharmacologic TherapySCRIPT
Veterans Health
AdministrationVHA
Washington (DC)
Business Group on HealthWBGH
Glossary
of Terms
Adverse event:
an injury that was caused by medical management and that results
in measurable disability.
Error:
the failure of a planned action to be completed as intended or the
use of a wrong plan to achieve an aim. Errors can include problems
in practice, products, procedures, and systems.
Unpreventable
adverse event: an adverse event resulting from a complication
that cannot be prevented given the current state of knowledge.
Medical error:
an adverse event or near miss that is preventable with the current
state of medical knowledge.
Near miss:
an event or situation that could have resulted in an accident, injury
or illness, but did not, either by chance or through timely intervention.
System:
a regularly interacting or interdependent group of items forming
a unified whole.
Systems error:
an error that is not the result of an individual’s actions, but
the predictable outcome of a series of actions and factors that
comprise a diagnostic or treatment process.
Internet
Citation:
Doing What
Counts for Patient Safety: Federal Actions to Reduce Medical Errors
and Their Impact. Report of the Quality Interagency Coordination
Task Force (QuIC) to the President, February 2000. Quality Interagency
Coordination Task Force. Washington, DC. http://www.quic.gov/report/
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