Order Code RL32092
CRS Report for Congress
Received through the CRS Web
Medical Malpractice:
The Role of Patient Safety Initiatives
Updated January 24, 2005
Bernadette Fernandez
Analyst in Social Legislation
Domestic Social Policy Division
Fran Larkins
Information Research Specialist
Information Research Division
Congressional Research Service ˜ The Library of Congress
Medical Malpractice:
The Role of Patient Safety Initiatives
Summary
Medical malpractice and malpractice insurance continue to be issues of great
concern to physicians, consumers, legislators, and others. Most of the discussion
about rising malpractice insurance premiums has centered on limiting the damage
awards in malpractice suits, though some attention also has been given to insurance
reforms. A third, related area that has received less public notice in malpractice
discussions of recent years is patient safety. Patient safety refers to the panoply of
rules, practices, and systems related to the prevention of medical injury. Intrinsic to
patient safety efforts are strategies to prevent medical errors.
While patient safety and medical errors have generated a great deal of discussion
in legislatures in the past several years, such discussion typically has taken place
separately from the debates concerning malpractice. Legislation introduced in the
108th Congress was no exception. The House-passed Patient Safety and Quality
Improvement Act (H.R. 663) and the Senate-approved measure of the same name
(S. 720) encouraged the voluntary reporting and analysis of medical error data.
Medical liability issues, however, were addressed in other legislation; specifically,
the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003
(H.R. 5) and the Patients First Act of 2003 (S. 11). Given the bipartisan support
behind patient safety legislation, the 109th Congress will likely re-visit patient safety
issues specifically and quality issues in general.
The separation of patient safety concerns from medical malpractice issues has
not always been the case. Several states have passed legislation that included
provisions which addressed both malpractice and patient safety issues. Research
studies have explored the links between the two issues. Therefore, it may be
appropriate and timely to re-consider these issues collectively, and re-visit the role
patient safety initiatives could play in the prevention of both medical errors and
medical malpractice.
Strategies to enhance patient safety differ according to the specific provider type
targeted. For instance, physician education includes providing clinical guidelines
about appropriate treatments for specific medical conditions, while hospital education
involves performance feedback from an external organization. At the same time,
general approaches may apply to both physicians and hospitals. For example,
medical error reporting is a key component for patient safety enhancement, regardless
of the provider focus.
The impact of patient safety initiatives continues to be an open question.
Individual initiatives have resulted in promising outcomes, but the overall impact of
these efforts has been mixed. This is, in large part, because implementation has not
been as pervasive as initial intentions suggested, and also because not enough
research has been done to identify, enumerate, and assess patient safety efforts. This
report will be updated periodically.
Contents
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Patient Safety and Medical Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
The Institute of Medicine Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Patient Safety Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Physician-Focused Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Licensing and Disciplining of Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
State Medical Boards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
National Practitioner Data Bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Public Disclosure of Reported Information . . . . . . . . . . . . . . . . . . . . . . 8
Provider Education, Feedback, and Practice Guidelines . . . . . . . . . . . . . . . . 8
Hospital-Focused Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Reporting of Medical Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Lessons from the Airline Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Characteristics of Health Care Reporting Systems . . . . . . . . . . . . . . . 11
“Honesty Policies” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Clinical Standards in Hospital Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Information Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Proposed IT Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Technology Implementation Considerations . . . . . . . . . . . . . . . . . . . . 14
Impact of Patient Safety Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Selected Results from the Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Tracking and Reducing Medical Errors . . . . . . . . . . . . . . . . . . . . . . . . 15
Publicizing Hospital Performance Data . . . . . . . . . . . . . . . . . . . . . . . . 15
Disclosing Medical Errors to Injured Patients . . . . . . . . . . . . . . . . . . . 16
Using Information Technology in Health Care Delivery . . . . . . . . . . . 16
Barriers to the Adoption of Patient Safety Programs . . . . . . . . . . . . . . . . . . 17
Cultural Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Limited Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Liability and Professional Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Lack of Patient Safety Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Federal and State Patient Safety Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Federal Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
State Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
State Patient Safety Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Medical Malpractice:
The Role of Patient Safety Initiatives
Background
Medical malpractice and malpractice insurance continue to be issues of great
concern to physicians, consumers, legislators, and others.1 Most of the discussion
about the rising cost of malpractice insurance (also called “professional liability
insurance”) has centered on limiting the damage awards in malpractice suits. Some
attention has been given to insurance market reforms. A third, related area which has
received less public notice in malpractice discussions is patient safety.
Patient safety refers to the panoply of rules, practices, and systems related to the
prevention of patient injury, also known as “adverse events.” Intrinsic to patient
safety efforts are strategies to prevent medical errors; i.e., the use of an incorrect
medical treatment or the failure of a specific treatment to achieve the intended result.2
While patient safety and medical errors have generated a great deal of discussion in
the media and in legislatures in the past several years, such discussion typically has
taken place separately from the vigorous debates concerning malpractice litigation.
Legislation introduced in the 108th Congress was no exception. The House-passed
Patient Safety and Quality Improvement Act (H.R. 663) and the Senate-approved
measure of the same name (S. 720) used the identical approach to address medical
errors: voluntary reporting. Both bills established a system for the voluntary
submission and analysis of medical error data (see below for further discussion).
However, medical liability issues were addressed in other legislation; specifically, the
Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003
(H.R. 5) and the Patients First Act of 2003 (S. 11). Both of these bills focused on tort
reform3 as the solution to increasing malpractice premiums. For the 109th Congress,
both patient safety and medical malpractice legislation will likely be revisited.
The separation of patient safety concerns from medical malpractice issues has
not always been the case. During the first malpractice insurance “crisis” in the mid-
late 1970s, California passed a pioneering bill (the Medical Injury Compensation
Reform Act [MICRA]) that included provisions not only limiting damage awards
1 Medical malpractice generally is defined as any deviation from the accepted medical
standard of care that causes injury to a patient. Malpractice insurance is a contractual
arrangement whereby an insurance company accepts the financial responsibility for payment
of malpractice claims against a health care provider, in return for a premium.
2 Medical errors do not necessarily result in injury to a patient.
3 A tort is a civil (as distinct from a criminal) wrong, other than a breach of contract, that
causes injury for which the victim may sue to recover damages.
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and other legal reforms, but also strengthening patient safety and physician
disciplinary activities. But the controversy over damage awards eclipsed those other
topics, and subsequent state and federal legislative activity centered on reforming
malpractice tort law.
This dynamic was repeated during the second malpractice insurance “crisis”
during the mid-late 1980s. Another spate of malpractice tort reforms were proposed
and debated, separate from the proposals related to health care quality and the mostly
academic discussions concerning patient safety. Through most of the 1990s, patient
safety issues did not command widespread legislative attention, despite research that
found that medical errors caused significant health and financial problems for the
individuals injured, their families, and the nation as a whole.
It wasn’t until a 1999 Institute of Medicine study on medical errors, which
avoided including discussion about the malpractice insurance controversy, that the
issue of patient safety finally reached national prominence. Since publication of that
report, the intense media attention helped propel patient safety issues to the forefront
of health care debates and legislative proposals. Given the continuing interest in
patient safety and observations by some that the nation is in the midst of its third
malpractice insurance “crisis,” federal and state legislators have developed legislation
to address each issue. Therefore, it may be appropriate to consider these issues
collectively, and re-visit the role patient safety initiatives could play in the prevention
of both medical errors and medical malpractice.
The link between malpractice and medical error has its detractors. Some health
care observers refer to studies that found that the majority of malpractice claims filed
do not involve negligent medical care.4 In other words, the majority of patients who
file malpractice claims have suffered medical injuries, but not of the type that would
be “legally compensable” on the grounds of provider negligence.5 Moreover, a
seminal medical errors study showed that many lawsuits are won by patients even
though expert reviewers cannot establish any evidence of negligence. At the same
time, only a small proportion of patients whose injuries are caused by negligence
actually end up filing a malpractice claim. Some observers cite the gap between
malpractice claims and provider negligence as evidence of a faulty litigation system
in need of reform. Thus, they support solutions which target the legal system, such
as malpractice tort reforms.6
Other observers argue that the emphasis on liability and damage awards
negatively impacts the patient-provider relationship which, in turn, affects
malpractice claims. A number of studies have shown that communication
breakdowns lead to patient frustration and anger which increases the likelihood of
4 P. C. Weiler et al., A Measure of Malpractice: Medical Injury, Malpractice Litigation, and
Patient Compensation (Cambridge, MA: Harvard University Press, 1993).
5 G.B. Hickson et al., “Development of an Early Identification and Response Model of
Malpractice Prevention,” Law and Contemporary Problems, Winter 1997, p. 9.
6 For information on state laws concerning punitive damage awards in malpractice cases, see
the CRS Report RL31721, Punitive Damages in Medical Malpractice Actions: Burden of
Proof and Standards for Awards in the Fifty States, by Henry Cohen.
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litigation.7 Some health care observers assert that the collapse in communication and
trust, in addition to a health care delivery system in which time spent providing
services has been compressed, adds an unhealthy, antagonistic component to modern
medicine. They conclude that this adversarial element acts as a significant barrier to
quality improvement and patient safety efforts.
Such an assessment was reflected in an editorial by several well-respected
patient safety researchers who observed that the threat of malpractice liability to deter
bad medical care has “had limited impact on reducing patient injuries.”8 Indeed, the
variety of disciplines involved in the malpractice insurance debate (i.e., medicine,
insurance, law, government) speaks to the complexity of the issues. It follows that
any meaningful discussion about them necessitates a comprehensive analysis and
discussion. Patient safety is a key part of such an analysis.
Patient Safety and Medical Errors
While concern about patient injuries is not new, data about adverse events was
sparse and limited until fairly recently. A small, pioneering study looked at a sample
of 23 California hospitals in 1974.9 That analysis found that almost one in 20
hospitalizations, or nearly 5%, involved injuries to patients. Extrapolating from the
number of hospitals in the sample to all CA hospitals, the study investigators
estimated that there were 140,000 patient injuries in that state alone in 1974. A more
comprehensive study was undertaken in 1991, largely in response to the lack of
robust patient injury data, by members of the Harvard Medical Practice Study
(HMPS) Group. The group analyzed 1984 data from over 30,000 discharges at 51
New York hospitals and more than 67,000 litigation records, and the study is
considered to be the most influential patient injury study. Similar to the CA
investigation, the HMPS found that the proportion of hospitalizations involving
medical injuries was around 4%. Lucian L. Leape, one of the HMPS investigators,
later extrapolated from the NY data and estimated that 180,000 individuals died
annually in the U.S. as a result of medical injury. He noted that this was equivalent
to “three jumbo-jet crashes every 2 days.”10 In 1992, a subset of the HMPS
investigators conducted a validation study by reviewing 15,000 discharges from a
sample of 28 hospitals in Colorado and Utah. The findings of the CO-UT study
largely corroborated those of the NY study.
7 L. Landro, “The Informed Patient: Some Hospitals Offer New Service: Helping Patients
Complain,” Wall Street Journal, June 19, 2003.
8 L.L. Leape et al., “Promoting Patient Safety by Preventing Medical Error,” Journal of the
American Medical Association, vol. 280, no. 16, p. 1445.
9 For more detailed historical information, see P.M. Danzon, Medical Malpractice: Theory,
Evidence, and Public Policy (Cambridge, MA: Harvard University Press, 1985).
10 L. Sprague, “Reducing Medical Error: Can You Be as Safe in a Hospital as You Are in
a Jet?” National Health Policy Forum Issue Brief, May 14, 1999, p. 2.
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The Institute of Medicine Report
The analyses from the NY and CO-UT studies formed the bulk of the evidence
on which the Institute of Medicine (IOM) based its patient safety recommendations,
outlined in the 1999 report, To Err is Human: Building a Safer Health System.11 The
report’s findings immediately seized the attention of mainstream news media. Along
with dramatic stories about individuals seriously harmed by errors, the IOM Report
placed medical errors in the forefront of health care discussions. Most of the
attention focused on the IOM’s estimate of the number of deaths that could be
attributed to errors, between 44,000 and 98,000 annually. In addition, the report
estimated that the cost to the nation of all preventable adverse events was $17 billion
a year.
But beyond those dramatic statistics, the IOM Report emphasized a need to
move away from blaming individual providers and focus instead on preventing errors
via safer health care systems. The IOM concluded that medical errors generally are
the result of many variables. Since blaming a single person does nothing to change
those contributing variables, the same error probably would occur over and over
again. Thus, enhancing patient safety requires a systemic approach in order to make
changes to system conditions that lead to errors in the first place. In effect, this
conclusion broadened the medical errors discussion to include the characteristics of
health care delivery systems which contribute to the prevalence of adverse events.
Also, this groundbreaking approach to addressing errors was seen as an opportunity
for lessening the adversarial quality in patient-provider relationships engendered by
the malpractice liability controversy.
Patient Safety Initiatives
Soon after publication of the IOM’s findings, strategies to reduce medical errors
were put forth from both public and private sector entities. For example, 34 medical
error-related bills were introduced in state legislatures in the year following the
release of the IOM Report. The proposals addressed a broad spectrum of related
issues, such as adverse event reporting, reduction of medication errors, system-wide
analysis, and public disclosure of information.12 At the federal level, then-President
Clinton charged an interagency task force to inventory current federal efforts to
reduce errors and outline action items for future implementation. Three months later,
the task force’s report13 endorsed many of the IOM’s recommendations and
enumerated a diverse set of strategies for addressing them. Some of those strategies
included allocating funds to establish a patient safety center within the Agency for
Healthcare Research and Quality (AHRQ), implementing reporting systems at a
11 Institute of Medicine, To Err is Human: Building a Safer Health System (Washington:
National Academies Press,1999), [http://www.nap.edu/books/0309068371/html/].
12 L. Flowers, “State Responses to the Problem of Medical Errors: An Analysis of Recent
State Legislative Proposals,” National Academy for State Health Policy, Feb. 2002.
(Hereafter cited as Flowers, “State Responses to the Problem of Medical Errors.”)
13 Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and
Their Impact, [http://www.quic.gov/report/].
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number of federal agencies, and developing new labeling standards to prevent
medication errors.
In the private sector, one of the more visible responses was establishment of the
voluntary Leapfrog Group (Leapfrog). Founded by the Business Roundtable, an
association of CEOs from leading corporations, Leapfrog’s mission is to mobilize
purchasers of health insurance to alert health care providers that progress in patient
safety would be rewarded with preferential use. As a first step, Leapfrog
recommended three specific standards for comparing hospital performance: computer
physician order entry, evidence-based hospital referral, and intensive care unit
physician staffing.14 It also developed and conducted the Leapfrog Hospital Quality
and Safety Survey. The survey queries hospitals about their adherence to specific
quality standards, including the three original measures recommended by Leapfrog.15
Physician-Focused Initiatives
Some patient safety advocates point out that medical malpractice claims and
awards are not a reliable gauge of an individual physician’s competence. As
discussed earlier, only a small percentage of patients who experience medical injuries
end up filing malpractice claims, and of those who do file claims a majority did not
experience injuries that meet the legal definition for negligence. Therefore, even the
most conscientious physicians face uncertainty as to whether they will be sued, and
negligent physicians may not be held accountable through the legal system.16
In addition, questions remain as to whether the prior experience of being sued
or the threat of possible litigation make physicians practice medicine more safely.
Some studies point out that a “large body of research has accumulated showing that
medical malpractice liability causes doctors to practice defensive medicine.”17
Others suggest that the growth of cost-conscious managed care has limited
physicians’ ability to provide care that may not be medically necessary. They argue
that empirical studies on defensive medicine have produced mixed findings, with
“most failing to demonstrate any real impacts on medical practice arising from higher
14 “Computer physician order entry” refers to electronic prescribing systems that catch
errors at the time medications are ordered. “Evidence-based hospital referral” pertains to
a process by which patients with certain conditions are referred to hospitals known for better
health outcomes in treating such conditions. “Intensive care unit physician staffing” refers
to management and staffing of ICUs by “intensivists” — i.e., physicians with training in
critical care medicine.
15 The latest survey results can be found at [http://www.leapfroggroup.org/media/
file/Readout041231.pdf].
16 M.M. Mello, “Malpractice Liability and Medical Error Prevention: Strange Bedfellows?”
2003. (Hereafter cited as Mello, “Malpractice Liability.”)
17 U.S. Joint Economic Committee, “Liability for Medical Malpractice: Issues and
Evidence,” May 2003, [http://www.house.gov/jec/].
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malpractice premiums or prior experience of being sued.”18 Another issue for
consideration is that many physicians may not face the full financial consequences
of their professional conduct. Most physicians are insured against medical
malpractice, and premiums for professional liability insurance are not adjusted to
reflect provider experiences with malpractice claims or other disciplinary actions,
(i.e., malpractice premiums are not “experience rated”).
How then can patient safety be improved with the individual provider in mind?
Some have suggested that serious deviations from quality care can be addressed by
strengthening licensure and accreditation requirements, and modifying physician
disciplinary procedures. Others recommend a less-punitive, less-adversarial
approach of assessment, feedback, and ongoing professional education.
Licensing and Disciplining of Physicians
The regulation of physician licensure and standards for appropriate physician
conduct has traditionally been the responsibility of the states. Through the licensure
process states ensure that all licensed physicians have appropriate education and
training, and hold providers accountable to the recognized standards of professional
conduct. Under each state’s Medical Practice Act, the responsibility for physician
licensure and discipline rests with the state medical boards.19
State Medical Boards. Any disciplinary sanctions imposed by state medical
boards are reported to the Federation of State Medical Boards, medical credentialing
societies, and appropriate government agencies, including the National Practitioner
Data Bank (see below for more details). State medical boards also can assist the
public by disclosing the current status of a physician’s license, any disciplinary
actions, or, in some instances, any pending charges. Many state boards have
increased consumer accessibility to this information by making it available on the
Internet. For example, Massachusetts passed a pioneering law in 1996 making
information about physicians’ disciplinary activities, malpractice payments, and
criminal convictions available to the general public. Other states, including
California, Georgia, New York, Virginia, and Washington, now offer similar online
physician profiles.
Some consumer groups believe, however, that the state medical boards are not
doing an adequate job of protecting the public from negligent physicians, and that the
number of doctors disciplined is low compared with the number believed to be
providing substandard care. They have voiced concern regarding the boards’ reliance
on consumers to bring unprofessional conduct to their attention. Moreover, some
observers question the effectiveness of state medical boards in the disciplining of
physicians because doctors themselves make up the majority of those boards. Other
observers counter that medical boards are not given adequate resources to respond
to the large number of complaints that they receive. They assert that boards lack
18 Mello, “Malpractice Liability.”
19 Physicians who serve in the military, Veterans Administration, Public Health Service, the
National Institutes of Health, and other federal agencies are regulated by the federal
government.
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sufficient funding, authority, and information to be able to act in an appropriate and
timely manner. Boards also may not be able to respond quickly because formal
actions against physicians must follow a strict process of complaint, investigation,
and hearing.
The Federation of State Medical Boards (FSMB), a private, non-profit
association of state medical boards, has worked to improve state medical practice
acts and the effectiveness of the boards. The FSMB has also developed the
Federation Physician Data Center; a repository for formal actions taken and reported
against physicians by regulatory and licensing entities throughout the United States
and some other countries. Information on medical malpractice settlements or claims
is not collected. Reporting to the FSMB is voluntary and only actions that can be
legally released or are a matter of public record are included in the Data Center.
Beginning in 2001, FSMB reports on disciplinary actions against physicians became
available to the public.20
National Practitioner Data Bank. Established under the Health Care
Quality Improvement Act of 1986 and made operational in September 1990, the
National Practitioner Data Bank (NPDB) is a central repository for information about
physicians, dentists, and, in some cases, other health care professionals. It contains
reports on: (1) medical malpractice payments; (2) actions taken by a state Board of
Medical Examiners to suspend or revoke a practitioner’s license; and (3) actions
taken by a hospital or other health care entity to limit or revoke clinical privileges.
The intent of the data bank is to improve the quality of health care by encouraging
hospitals, state licensing boards, and other health care entities to identify and
discipline those who engage in unprofessional conduct, and to restrict the ability of
incompetent providers to move from state to state without disclosure or discovery of
prior adverse actions taken against them. While hospitals are the only health care
entities with mandatory requirements for querying the data bank, NPDB information
is available to state licensing boards, professional societies, certain federal agencies,
and others as specified in the statute. NPDB information is not available to the
general public.
Some legislators and consumer groups have advocated the public release of
NPDB information. They argue that the public has the right to know about adverse
actions against health care providers in their communities. Others, however,
question the quality of the NPDB data. According to a comprehensive General
Accounting Office (GAO) report,21 under-reporting may be a severe problem, so the
completeness and accuracy of the information is open to question. Health care
practitioners also oppose the public disclosure of NPDB information for liability and
professional reasons. They assert that the NPDB data can be easily misunderstood
by laypersons. For example, a simple comparison of malpractice payments made by
physicians in different specialties would produce misleading findings, since some
medical specialties typically have higher rates of malpractice suits than other
specialities. The same can be said about certain doctors who take on riskier cases
20 The information is available for a fee and can be found at [http://www.docinfo.org].
21 U.S. General Accounting Office, National Practitioner Data Bank — Major
Improvements Needed to Enhance Data Bank’s Reliability, GAO-01-130 (Nov. 2000).
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than their colleagues. Also, a data bank entry showing a payment for a malpractice
claim does not necessarily indicate negligent care. It is possible this was a case in
which the physician was not negligent, but settled out of court in order to avoid the
costs and publicity associated with a lengthy trial.
Public Disclosure of Reported Information. The concern that many
providers voice against making NPDB data public is the same one they express about
participating in reporting systems in general. Their concern is rooted in the
assumption that such information, whether it be about medical errors, adverse events,
or disciplinary actions, will be used against them professionally. At a time when
malpractice insurance is becoming increasingly expensive and difficult to find in
some regions, providers may believe they are being asked to disclose sensitive
information with no guarantee of legal, administrative, or professional protection.22
In addition, opponents of public disclosure argue that it creates strong disincentives
for openness and candor in the reporting system, thereby reducing the value of the
information gathered. Disclosure proponents argue that placing medical practitioners
on public notice creates strong incentives for quality improvement and assures
consumers that, at a minimum, a mechanism is in place to identify serious errors and
negligent providers. Moreover, they characterize physicians’ fear about liability as
unwarranted. For example, proponents of public reporting say that physicians in
states which have posted disciplinary actions on the Internet are reporting that they
have seen no negative impact from making this information public.23
Provider Education, Feedback, and Practice Guidelines
The Institute of Medicine’s report Health Professions Education: A Bridge to
Quality emphasizes that oversight and reporting must be part of an integrated
approach to improving patient safety which includes ongoing professional
development. They recommend enabling health care providers to maintain up-to-
date skills and competence through an approach that includes evaluation and
feedback by peers, medical boards, certification bodies, and employers.24
Some reporting systems, particularly those conducted by managed care
organizations (MCOs), are designed to furnish performance information to the
participating providers on how their practice compares with their peers or with
accepted practice guidelines. Practice guidelines provide recommendations about
appropriate medical care, and are designed to outline the range of treatments for a
given clinical situation at a given point in time. Such guidelines are developed from
research findings about the effectiveness of certain medical therapies and practices,
and expertise from practicing physicians. The Omnibus Budget Reconciliation Act
of 1989 (P.L. 101-239) provided funding for the development of clinical practice
guidelines and authorized the establishment of the Federal Agency for Health Care
22 Mello, “Malpractice Liability.”
23 “Doctors Resigned to Public Web Profiles,” American Medical News, May 5, 2003, p. 10.
24 Institute of Medicine, Health Professions Education: A Bridge to Quality (Washington,
National Academies Press, 2003). The report can be found at [http://www.nap.edu].
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Policy and Research (AHCPR).25 AHCPR ceased internal development of clinical
practice guidelines in 1996, and now supports external researchers in the creation and
dissemination of evidence-based reports.
Medical professional societies, research groups, and private-sector firms also
have developed practice guidelines. In addition, MCOs and other health care entities
have increasingly used practice guidelines and outcomes assessment (i.e., analysis of
the impact of certain treatments or procedures on patient health) to monitor and direct
the way physicians deliver health care. There is some concern, however, about the
effect of practice guidelines on changing physician behavior. A recent Rand study
found that U.S. physicians follow recommended “best practices” for diagnosis and
treatment only about 55% of the time.26 Some have urged that increased compliance
with guidelines should be combined with other efforts to improve health care quality,
such as: better reporting of the quality of care, greater use of computerization and
decision-support tools, increased patient involvement, and providing financial
incentives for investment in quality-improvement infrastructure.27
Studies have shown that clinical guidelines are most effective when delivered
by a “respected peer or ‘opinion leader.’”28 Many people believe that physicians are
the most appropriate persons to assess the quality of care delivered by other
physicians, and provide counseling or remedial education. Peer review may be
conducted at different levels: peer-to-peer, at individual hospitals or through outside
organizations, such as the Quality Improvement Organizations (QIOs) which contract
with the Medicare program to monitor beneficiaries’ quality of care.29
The success of feedback to medical practitioners also depends on the
confidentiality, timeliness, and quality of the feedback, as well as provider immunity
from administrative and legal reprisals. Similar to the public disclosure debates,
supporters of confidentiality and immunity in provider feedback initiatives say that
such assurances are necessary to move away from the “blame game” and encourage
reporting. Detractors say that such features support a solely internal system of
monitoring which is inadequate for proper intervention and enforcement.
25 AHCPR succeeded the National Center for Health Services Research and Health Care
Technology Assessment. AHCPR was reauthorized in 1999 as the Agency for Healthcare
Research and Quality (AHRQ).
26 E. McGlynn et al., “The Quality of Health Care Delivered to Adults in the United States,”
New England Journal of Medicine, June 26, 2003.
27 E.P. Steinberg, “Improving the Quality of Care — Can We Practice What We Preach?”
New England Journal of Medicine, June 26, 2003.
28 G.B. Hickson et al., “Development of an Early Identification and Response Model of
Malpractice Prevention,” Law and Contemporary Problems, Winter 1997, p. 26.
29 QIOs are successors to the Peer Review Organization (PRO) program established by
Congress under the Omnibus Budget Reconciliation Act of 1986.
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Hospital-Focused Initiatives
With the majority of medical error studies based on inpatient data and the IOM
Report’s emphasis on addressing system failures, most patient safety initiatives thus
far have focused on hospitals. An abundance of solutions have been suggested, such
as: (1) reporting hospital performance, (2) disseminating clinical protocols, and (3)
adopting innovative technology, to aid hospitals in the creation of a “culture of
safety.” This endeavor was further energized by the implementation of patient safety
standards by the nation’s largest hospital accrediting body, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO). These standards stressed not
only a hospital’s role in the prevention of medical errors, but also its responsibility
for disclosing to patients when they have been harmed by such errors.30
Reporting of Medical Errors
The JCAHO standards, along with other efforts in the patient safety arena,
emphasize the importance of “transparency” in health care delivery. Communication
is the principal medium through which transparency concerns are addressed, and one
of the key features of a patient safety-based communication strategy is a system for
reporting adverse events.
Lessons from the Airline Industry. Some of the early thinking on this
issue borrowed ideas from other industries, particularly aviation. In the airline
industry, pilots, controllers, and others can submit information to the Aviation Safety
Reporting System (ASRS), which is administered by the National Aeronautics and
Space Administration (NASA).31 The ASRS is a system for reporting “near misses;”
that is, incidents that do not result in accidents but nonetheless violated standard
practices or rules. The system also analyzes the root causes of near misses, and
communicates the findings to those involved as well as others working under similar
conditions. Such a design is considered useful for identifying possible hazards and
developing solutions to prevent accidents. Key characteristics of the ASRS are that
it operates independently of any regulatory body, is completely confidential, and
reporters are given immunity from retribution. In almost 30 years of existence,
ASRS has received and processed more than 600,000 reports, and many aviation
experts credit ASRS with helping to greatly increase commercial aviation safety.
However, it is important to note that the ASRS does not deal with incidents which
result in passenger injury or aircraft damage. Serious aviation accidents are
investigated by the National Transportation Safety Board under a different system.
The dual-system arrangement for addressing near misses and serious errors in
aviation parallels the IOM’s recommendation for two-tier medical error reporting.
The IOM recommended establishing a mandatory reporting system to hold hospitals
and other health care facilities accountable for errors that lead to serious injury or
death. It also encouraged the development of voluntary, confidential systems for
30 JCAHO, press release, “Hospitals Face New JCAHO Patient Safety Standards on July 1,”
June 28, 2001.
31 Additional information on ASRS can be found at [http://asrs.arc.nasa.gov/main_nf.htm].
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reporting no harm events (a medical error that has been carried out but does not result
in injury), minimal harm events, and near misses. Analysis of such information
could then be used to identify system vulnerabilities and develop preventive
strategies.
Characteristics of Health Care Reporting Systems. There is no
consensus among stakeholders regarding the optimal design for a health care
reporting system, including who should report and what they should report. A key
area of discussion is whether a reporting system should mandate participation or be
voluntary.32
Mandatory Reporting System. The primary purpose of a mandatory
reporting system is to hold providers accountable by ensuring that serious mistakes
are reported and investigated, and that appropriate follow-up action is taken. Medical
practitioners that continue unsafe practices risk citations, penalties, sanctions,
suspension or revocation of licenses, and possible public exposure and loss of
business. However, the focus on collecting adverse event data and disciplining
individual providers bypasses the majority of errors; errors which are caused or
exacerbated by poorly-designed health care delivery systems.
Voluntary Reporting System. According to the IOM, voluntary reporting
systems play a “valuable role in encouraging improvements in patient safety.”33
Experience from ongoing voluntary reporting efforts have shown that such systems
are helpful in identifying the following types of events: (1) errors that occur on such
an infrequent basis that they would be difficult to detect by any one single health
organization, and (2) error trends or patterns which allude to system problems that
may impact all health care organizations.34 Identification of such events could
facilitate the development of strategies to prevent more serious errors from occurring.
Nevertheless, key criticisms against voluntary systems are that due to their very
design, under-reporting is a constant concern, and such systems are inadequate for
addressing egregious medical errors.
Examples of Reporting Systems. While there is no consensus across
organizations regarding error reporting, some entities have made progress in framing
the debate by launching individual initiatives. For example, in 1996 JCAHO
implemented its Sentinel Event Policy (SEP).35 The policy outlines JCAHO’s
expectations for how health care organizations should address sentinel events; i.e.,
medical events involving death or severe physical and/or psychological injury. The
SEP instructs organizations to identify sentinel events, complete a thorough analysis
of the root causes of those events, implement strategies to reduce their prevalence,
32 “Medical Mistakes,” CQ Researcher, vol. 10, no. 7.
33 To Err is Human: Building a Safer Health System, Institute of Medicine, Committee on
Quality of Health Care in America, 1999, p. 104.
34 Ibid. p. 87.
35 Additional information about JCAHO’s Sentinel Event Policy can be found at
[http://www.jcaho.org/accredited+organizations/ambulatory+care/sentinel+events/se_pp.
htm].
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and track the effectiveness of those strategies. The policy also encourages health care
organizations to share their findings with JCAHO so that it can pass those “lessons
learned” to others. As of December 2004, JCAHO has released 33 alerts that
described different types of serious medical events and suggested ways to prevent
them. The alerts also included statistics on the prevalence of these medical events,
but did not name specific hospitals.
On the mandatory side, 21 states mandate some type of medical error
reporting.36 The reporting requirements vary widely from state to state. For instance,
regarding the type of information collected, states mandate the reporting of
medication errors, general medical errors, or adverse medical events. State mandates
also differ in what health facilities are required to do with reported information, from
reviewing reports about medical violations, to sharing error information with
patients, to disseminating evidence-based, error-prevention protocols. In general,
the quality and quantity of information collected are major concerns. Only a few
states get enough information to conduct proper analyses, and some of the
information reported is not useful. But a few states are able to conduct trend analyses
and use the information as part of their regulatory apparatus.37
“Honesty Policies”. While most of the attention paid to better
communication has centered on reporting systems, a few health care entities have
implemented programs which directly engage individuals injured by medical errors.
“Honesty policies” have been instituted in a small minority of hospitals to encourage
providers and staff to admit that they have committed errors. In addition, these
institutions offer compensation to injured patients to pay for medical treatment or
cover lost income. Such practices, however, are uncommon. Providers typically
resist disclosure of adverse medical events.38 Supporters of honesty policies assert
that such policies help maintain openness and trust in patient-provider relationships,
which may diffuse potentially volatile situations. Others argue that these policies
elicit declared admissions of guilt, thereby exposing medical practitioners to even
greater liability.
Clinical Standards in Hospital Settings
Medical guidelines generally are developed with a particular medical condition
in mind and individual providers as the target audience. However, given the
increased awareness about medical errors caused by weaknesses in health care
systems, there is more attention being paid to the application of clinical standards to
hospitals. For example, AHRQ developed a set of Quality Indicators (QIs) to
measure the level of quality associated with the medical care being delivered in
hospitals. (These QIs were developed using only hospital administrative data.) One
of the three modules which make up the QIs is a set of Patient Safety Indicators
36 A. McKinley, “Medical Errors and Patient Safety,” Health Policy Tracking Service Issue
Brief (Oct. 4, 2004).
37 According to National Academy for State Health Policy staff.
38 C. Liebman and C. Hyman, “A Mediation Skills Model to Manage Disclosure of Errors
and Adverse Events to Patients,” Health Affairs, July/August 2004.
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(PSIs). The PSIs provide information on potential inpatient adverse events, such as
accidental puncture, obstetric trauma, transfusion reaction, etc. AHRQ encourages
hospitals to use the PSI software to identify and assess patient safety at their
facilities.
Information Technology
Another area on which a great deal of attention is focused is information
technology (IT). Many observers believe that the health care delivery lags behind
other industries in utilizing such technology and should incorporate these innovations
at multiple levels in order to enhance patient safety. The IOM’s report, Crossing the
Quality Chasm: A New Health System for the 21st Century,39 concluded that IT’s role
in the future of health care delivery is key, and the automation of health care
transactions is fundamental to the prevention of medical errors.
Proposed IT Initiatives. The applicability and potential benefits of IT to
health care are immense. Supporters recite a litany of uses: patient-physician
communication via e-mail, bar-coding of pharmaceuticals, instantaneous retrieval
and sharing of patient records, etc. Some e-health care pioneers tout the savings in
time and resources, in addition to a reduction in medical errors, resulting from IT
investments.
A number of public and private-sector organizations, to varying degrees, have
incorporated IT into their programs or operations. For example, President Bush has
stated his commitment to transforming the health care system by encouraging the
adoption of information technologies. In April of 2004, the White House unveiled
a proposal to encourage the adoption of IT innovations in both private and public
health care settings. The proposal included requests in the President’s FY2005
budget for $100 million to be split evenly among AHRQ and HHS for demonstration
grants to “test the effectiveness of health information technology and establish best
practices for more widespread adoption in the health care industry.”40 The final
budget approved the $50 million request for AHRQ, but zeroed out the remaining
$50 million that would have gone to the Office of the National Coordinator for
Health Information Technology.
The Food and Drug Administration (FDA) issued a final rule on February 26,
2004 that required bar codes on labels for pharmaceuticals and biological products,
in order to reduce the probability of errors which cause adverse medical events. The
FDA estimated that the rule would prevent nearly a half-million drug and transfusion
errors over the next two decades.41
39 Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st
Century (Washington: National Academies Press, 2001), [http://www.nap.edu/books/
0309072808/html/].
40 White House, A New Generation of American Innovation (April 2004), pp. 2-3,
[http://www.whitehouse.gov/infocus/technology/economic_policy200404/innovation.pdf].
41 Food and Drug Administration, press release, “HHS Announces New Requirements for
(continued...)
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A related strategy to reduce ADEs comes from the private-sector Leapfrog
Group. One of the three measures which form the core of its hospital performance
monitoring efforts is implementation of computer physician order entry (CPOE)
systems. Such systems allow physicians to order medications electronically and
alerts them to possible prescribing errors.
In addition to government officials and health care practitioners, corporate
managers recognize the benefit of adopting technology for patient safety
enhancement. For example, the Health Information and Management Systems
Society, a health care IT member organization, conducts an annual survey of chief
information officers (CIOs) at integrated delivery systems, multi-hospital systems,
and stand-alone healthcare facilities from around the country. Last year’s survey
results revealed that almost half of CIOs cited reduction of medical errors and
promotion of patient safety as a current and near-term priority. Only one other
activity (upgrade security/HIPAA compliance) was named by more CIOs as an IT
priority.42
Technology Implementation Considerations. While the potential
benefits from IT are great, so are the implementation challenges. One of the chief
challenges relates to the up-front investment. For instance, the FDA’s drug bar code
policy likely will require hospitals to spend over $7 billion on necessary equipment.43
In addition, there are costs associated with training staff, maintaining a technical
assistance capacity, and updating systems and applications. There also are other less
tangible but nonetheless considerable barriers to IT adoption, including data privacy,
system security, and overall reliability. Perceptions of value depend heavily on how
those concerns are addressed. And, lastly, culture also plays a substantial role.
Familiarity and comfort with electronic systems affect how well consumers,
providers, insurers, and payors will respond to e-health care efforts.
Impact of Patient Safety Programs
The specific challenges associated with IT adoption reflect the larger concerns
regarding adoption of patient safety programs in general. Individual initiatives have
resulted in promising outcomes, but the overall impact of these efforts has been
mixed. This is, in large part, because implementation has not been as pervasive as
initial intentions suggested, and also because not enough research has been done to
identify, enumerate, and assess patient safety efforts.
41 (...continued)
Bar Codes on Drugs and Blood to Reduce Risks of Medication Errors,” Feb. 25, 2004,
[http://www.fda.gov/bbs/topics/news/2004/hhs_022504.html].
42 Health Information and Management Systems Society, “Healthcare CIO Results: Key
Trends Index,” Feb. 23, 2004, [http://www.himss.org/2004survey/docs/Healthcare_CIO_
key_trends.pdf].
43 “FDA Proposes Bar Codes for Medications, New Error Reporting System,” American
Health Line, Mar. 14, 2003.
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Selected Results from the Field
While it would be very difficult to provide a comprehensive, quantitative
assessment of the impact of patient safety programs, some insight can be gleaned
from individual, private-sector initiatives, as well as public efforts. It is important
to note that the results of specific programs are highly dependent on the environment
in which they operate, the target audience, and the level of resources provided.
Tracking and Reducing Medical Errors. The Agency for Healthcare
Research and Quality (AHRQ) submitted an interim report to the Senate
Appropriations Committee which included how health care facilities track and record
medical errors, and discussed how such information may be used to increase patient
safety.44 Hospitals and other health care facilities used a variety of approaches in
their efforts to reduce errors. These approaches include not only investments in
technology and development of patient safety procedures, but also less well-known
but equally important strategies, such as changes in organizational culture,
involvement of key leaders, and education of providers. Such a breadth of activities
underscored the necessity of implementing a comprehensive approach to reduce
medical errors, instead of relying on a single strategy (e.g., information technology).
Because there was no comprehensive data which described how hospitals use
medical errors information, AHRQ issued a contract to develop a survey to collect
reporting data from hospitals. The expectation is that the survey results can be used
to better understand how error data is being used by health care facilities as a patient
safety management tool.
Publicizing Hospital Performance Data. Overall, the research on the
impact of publicizing hospital performance measures shows mixed results. Some
findings show that patient mortality decreased after hospital performance data was
released, whereas other findings showed no effect. While these studies were not
necessarily focused on the prevention of medical errors, they still provide some
indication of how similar programs may affect patient safety efforts in general.
One study of a hospital reporting system in Wisconsin highlighted some of the
common concerns involved in such efforts.45 The study assessed the impact of
disclosing the findings from the “QualityCounts” Report which compared the
performance of 24 hospitals. In this study, some hospitals’ performance data was
made public; other hospitals’ data was not publicized. The end results provided
some evidence of the value of publicizing performance data to encourage quality
improvement activities. For example, hospitals with low scores for obstetric and
cardiac care, whose results were made public, were later involved in the most quality
improvement efforts. In contrast, the hospitals whose performance was not made
public had the lowest level of quality improvement activity. Not surprisingly, the
analysis also found that making performance data public generated feelings of
44 Agency for Healthcare Research and Quality, Interim Report to the Senate Committee on
Appropriations, AHRQ Publication No. 04-RG005 (Dec. 2003), [http://www.ahrq.gov/
qual/pscongrpt/].
45 J.H. Hibbard, J. Stockard, and M. Tusler, “Does Publicizing Hospital Performance
Stimulate Quality Improvement Efforts?” Health Affairs, vol. 22, no. 2 (March-April 2003).
CRS-16
distrust and anger among the participating hospitals. All of the hospitals had a
slightly negative view of public reporting in general, although they differed with
respect to how they thought such reporting would affect their public image. As to be
expected, hospitals with higher scores were more likely to assert that their public
image would be helped, while those with lower scores were more likely to assert that
their image would be hurt.
Disclosing Medical Errors to Injured Patients. Anecdotal evidence
suggests a positive impact of “honesty policies” on the reduction of malpractice
claims. The Veterans Affairs medical center in Lexington, Kentucky regularly is held
up as a model for such policies. The Lexington center chose to adopt the practice
after dealing with two costly malpractice cases. Since then center administrators
claim that their policy has led to savings, partly due to decreased legal expenses.
Also, the center did not experience a deluge of malpractice litigation as initially
feared. Copic Cos., a malpractice insurer in Denver, had similar experiences.
Copic’s policy directs providers to report medical complications and adverse events.
Copic responds within 72 hours with offers to compensate the patient for medical
expenses related to injuries caused by errors and lost wages. According to Copic,
this policy has led to a reduced number of claims and smaller claim payments.
Despite these promising outcomes, some observers urge caution. They assert
that patients may not receive adequate compensation without the assistance of legal
counsel. Furthermore, these policies are not adequate mechanisms for addressing
very serious medical errors (e.g., patient deaths). Others point out that it would be
inaccurate to generalize the experience of the Lexington center to the general
population. They note that VA patients generally are older men with finite resources;
individuals who may have limited expectations and a lower-than-average inclination
to sue.46
Using Information Technology in Health Care Delivery. Individual
efforts to utilize information technology in health care generally have increased the
quality of health care. For example, in order to overcome the lack of specialists in
a rural area in California, some providers use e-mail to consult with specialists
elsewhere. A Spokane, Washington medical center built an IT system to provide 24-
hour pharmacist coverage for review of all medication orders. A heart institute in
Kansas City, Missouri is electronically linked to a larger medical system which
allows institute staff to remotely monitor cardiac patients at each of the system’s care
locations.
Specific IT initiatives also have enhanced patient safety. For instance, one study
found that the rate of serious medication errors fell more than 50% when
computerized prescribing systems were used.47 Yet, despite the enthusiasm
expressed by some experts for the use of IT in health care, the adoption of such
46 A.W. Wu, “Handling Hospital Errors: Is Disclosure the Best Defense?” Annals of Internal
Medicine, vol. 131, no. 12.
47 D.W. Bates et al., “Effect of Computerized Physician Order Entry and a Team
Intervention on Prevention of Serious Medication Errors,” Journal of the American Medical
Association, Oct. 21, 1998.
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technology has progressed slowly, especially in smaller medical settings. For
example, less than 10% of medical practices with less than 50 physicians “make
significant use of IT.”48
Barriers to the Adoption of Patient Safety Programs
Cultural Issues. Just as there are numerous solutions proposed to enhance
patient safety, so to are there numerous barriers to implementing those solutions.
Part of the reason why more has not been done is cultural. Medicine is a
conservative discipline which does not change easily. Providers, especially
physicians, place great value on their professional autonomy and expertise. In an
environment such as this, efforts to change day-to-day practice patterns by outsiders
are met with resistance. Cultural barriers apply not only to providers, but to other
players in the health care system. For instance, proponents of publicizing patient
safety information note the central role of the consumer. But study after study has
shown that the vast majority of consumers generally do not seek out, use, or
understand the information being made available to the public.49
Limited Resources. There are also resource issues contributing to the lack
of progress in instituting patient safety programs. The cost of investing in equipment,
staff, and supplies are of paramount concern.50 For example, state mandatory
reporting systems are hampered by insufficient funding. The budgets for many state
programs are small relative to their responsibilities, and some recently-enacted
programs have not been implemented because of lack of funds. Some observers also
point out that federal reimbursement neither takes into account medical error rates
nor implementation of error reduction measures, so there is little incentive for
providers to enhance patient safety. Unless a “business case” can be made for the
potential savings resulting from patient safety initiatives, cost will continue to be a
substantial barrier to such efforts. Some organizations have launched small
initiatives to address these financial feasibility concerns. For example, in April of
2003, a coalition of providers, plans, purchasers, and others launched “Bridges to
Excellence,” an incentive program to reward physicians for providing high-quality
care. In a similar move, HHS announced in July of that same year the start of a pilot
project which would give higher Medicare reimbursements to hospitals that perform
well on selected quality-of-care standards.
Additional resource concerns focus on the time and effort needed to design,
implement, and maintain patient safety programs, including training staff. Some
argue that this detracts from time that could be spent on direct health care. However,
others counter that these efforts are a more efficient use of time and money in the
long run.
48 [http://www.health-itworld.com/enews/01-18-2005_506.html]
49 M.N. Marshall, P.G. Shekelle, S. Leatherman, and R.H. Brook, “The Public Release of
Performance Data: What Do We Expect to Gain?” Journal of the American Medical
Association, vol. 283, no. 14.
50 J. Rosenthal, M. Booth, and A. Barry, Cost Implications of State Medical Error Reporting
Programs: A Briefing Paper (National Academy for State Health Policy, May 2001).
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Liability and Professional Concerns. A third set of barriers are prompted
by concerns about professional and legal liability. As was mentioned earlier, some
of the resistance to error reporting and public disclosure is born from the fear that
such activities would make providers more vulnerable to claims of malpractice.
Therefore, individual practitioners and hospitals remain cautious about implementing
programs which potentially could be used against them in the courtroom, on the
career ladder, and in the marketplace. For instance, the Massachusetts Group
Insurance Commission (GIC), the entity that provides health insurance coverage and
other benefits to the state’s employees, dependents, and annuitants, ordered its health
plans to collect health care quality information based on Leapfrog’s safety standards.
GIC’s intention was to use this data for hospital comparisons. Most of the GIC
hospitals refused to provide the information. Hospital administrators declared that
their respective institutions were working at improving patient safety, but were
concerned about the specific questions being asked. A Massachusetts hospital
association spokesman noted that hospitals thought that the Leapfrog standards were
too narrowly defined, and that they preferred an approach which took into account
the progress that had already been made at individual institutions.51
Lack of Patient Safety Research
In addition to implementation barriers, the difficulty in assessing the impact of
error prevention efforts also relates to the lack of research in this area. Three of the
most highly-regarded experts on patient safety concluded that health care studies
have focused on biomedical research for decades. In contrast, “error prevention —
especially the systems issues that underlie a great proportion of patient injury — is
a young field, which has commanded the attention of only a small number of
researchers and, until recently, has received little funding.”52 To illustrate, the $50
million appropriated to AHRQ in support of patient safety-related research and other
activities in FY2001 represented the single largest investment in this area by the
federal government. However, this appropriation amounts to less than one-quarter
of 1% of the FY2001 budget for the National Institutes of Health.
Federal and State Patient Safety Activities
Congressional interest in activities at the federal and state levels has evolved
from generic quality issues to concerns related specifically to medical errors and
patient safety. As part of this evolution, the development and implementation of
legislative proposals has varied in scope, focus, and purpose.
51 J.H. Powell, “Hospitals Thwart Ratings Plan,” Boston Herald, Oct. 29, 2001.
52 L.L. Leape, D.M. Berwick, D.W. Bates, “What Practices Will Most Improve Safety?
Evidence-Based Medicine Meets Patient Safety,” Journal of the American Medical
Association, vol. 288, no. 4, pp. 503-504.
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Federal Legislation
Since the states traditionally play the role of regulator of provider behavior, the
federal government’s presence historically has been small. But there was growing
realization in the late 1970s and throughout the 1980s that the need for quality
improvement in health care was so pervasive and severe that efforts of individual
states could benefit from federal initiatives. In the 1980s, the U.S. Congress passed
a number of legislative proposals designed to address health care quality through a
variety of mechanisms. Those mechanisms included state reporting systems, a
national data bank, Medicare peer review, and practice guidelines. In general, the
proposals focused on the performance of individual providers and generic quality
issues.53 Legislation to address system problems specifically relating to patient safety
issues did not come to fruition until the release of the IOM’s To Err is Human.
Several patient safety bills were introduced in the 106th Congress to address the
issues raised in the IOM Report. Members from both chambers and parties expressed
support for patient safety legislation, and introduced bills to develop guidelines for
error reporting, establish a federal quality improvement center, and fund
demonstration projects, among other initiatives. However, patient safety was
overshadowed by other legislative priorities and all six stand-alone bills failed to win
passage. The only federal action taken on this issue was a $50 million appropriation
to the Agency for Health Care Research and Policy (later re-authorized as AHRQ)
to support medical errors research.54 Most of the patient safety legislation first
introduced in the 106th Congress was reintroduced in the 107th. Once again, little
legislative action took place.
At the start of the 108th Congress, a number of patient safety bills were
introduced. H.R. 663, the Patient Safety and Quality Improvement Act, was the bill
that received the most legislative attention. Discussed within the House Energy and
Commerce Committee, the bill had broad bipartisan support. H.R. 663 proposed the
establishment of a voluntary reporting system. Under this system, health care
providers would submit confidential information on medical errors to “patient safety
organizations.” These organizations then would analyze the data, and offer feedback
to providers by recommending systems-based solutions. The information was
protected from use in any civil or administrative action, and from a Freedom of
Information Act request. The bill’s approach mirrored many public and private-
sector proposals for addressing medical errors by incorporating key components and
principles. Among the critical features incorporated in H.R. 663 were: voluntary
reporting, nonidentifiable information, analysis and feedback, protection of data from
legal discovery, and system-focused solutions. On February 12, 2003, the Energy
and Commerce Committee approved H.R. 663 and reported it to the full House. One
month later the bill passed the House on March 12 by a vote of 418-6.
53 For additional information, see U.S. Congress, House Committee on Ways and Means,
Medical Malpractice, Committee Print 101-26, 101st Cong., 2nd sess. (Apr. 26, 1990).
54 “Congress Clears Bill to Help Women With Cancer; No Progress on Medical Errors,”
2000 CQ Almanac, pp. 12-43.
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On the Senate side, the HELP Committee took up S. 720. The Senate bill was
broadly similar to the House-passed legislation. S. 720 also established a voluntary
system for the reporting of medical errors to patient safety organizations. But there
were a few differences between S. 720 and H.R. 663. The key difference was that
the Senate bill provided greater protection for providers who submitted medical error
information. Under S. 720, the submitted information was shielded from use not
only in civil and administrative proceedings, but in criminal actions as well (with
exception). On July 23, the Senate HELP Committee unanimously approved an
amended version of the bill and reported it to the full Senate. (For additional
information about H.R. 663 and S. 720, see the CRS Report RL31983, Patient
Safety: Legislation to Promote Voluntary Reporting of Medical Errors.)
Given the bipartisan support behind patient safety legislation, many health care
observers anticipate that the 109th Congress will revisit patient safety issues
specifically and quality issues in general. The new chairman of the Senate HELP
Committee has announced his interest in providing consumers with more quality
information and supporting the adoption of information technology. Similarly, the
chairman of the House Energy and Commerce Committee has voiced his support for
using IT to modernize medicine and decrease medical errors.
State Legislation
State activity in health care quality preceded the release of To Err is Human.
A JCAHO survey found that at least a third of the states had implemented reporting
systems by the late 1990s. The purpose of those reporting systems was mainly to
collect information on patient injuries or issues related to health care facilities (e.g.,
structural problems). Most of the reports came from hospitals and nursing homes,
but some states also collected data from other facilities, such as ambulatory care
centers. These systems reportedly protected data confidentiality, though privacy
policies varied from state to state. Only a few states aggregated the information or
conducted trend analysis. The overall effectiveness of these programs was hampered
by resource and data limitations.55
On the issue of patient safety specifically, state legislatures did not wait for their
federal counterpart to act. The number of patient safety-related bills introduced in
the states tripled in the year following the release of the IOM Report, then nearly
doubled in the year after that. Out of the 22 states that introduced bills in 2001 —
two years after the release of the IOM Report — half of them were introducing
medical error legislation for the first time. For 2000 and 2001, a total of 24 bills
were implemented, addressing a wide range of issues directly and indirectly-related
to patient safety (e.g., whistleblower protections).56
As previously noted, 21 states have some type of medical error reporting
mandate in place. The requirements cover a spectrum of issues, such as the type of
information to be reported, to whom the information is submitted, and for what
55 According to National Academy for State Health Policy staff.
56 Flowers, “State Responses to the Problem of Medical Errors.”
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purpose. For example, Washington requires the reporting of medication-related
errors, whereas Tennessee requires health care facilities to report any “unusual
events.” Arizona requires health care facilities to review reports made by medical
practitioners regarding violations of professional standards or the law. In contrast,
New Jersey requires hospitals and other institutions to report “serious medical errors”
to regulators and patients. Some states also included in their reporting mandates
provisions to prevent the discovery of error information in civil or administrative
proceedings.
While federal medical malpractice legislation usually did not include patient
safety provisions, there was some evidence that the link between the two issues has
been made at the state level. For example, Pennsylvania passed a bill in 2002 which
contained provisions concerning malpractice tort reform, insurance reform, and
patient safety enhancement. According to Governor Rendell, the comprehensive
approach was an attempt to address concerns about malpractice insurance and
medical safety. A couple of other states passed or debated similar bills which also
linked those two issues.
State Patient Safety Centers. A budding movement in the states is the
creation of state patient safety centers. In the past several years, six states (FL, MD,
MA, NY, OR, PA) have authorized the creation of these centers. The common
purpose of these entities is to promote patient safety efforts within the state. How
they plan to accomplish this varies by state. Their current and planned activities
include a spectrum of approaches: educating consumers and providers about safety
issues, developing systems for error reporting and analysis, recommending patient
safety goals to the state, and supporting collaboration among public and private
sector organizations are just a few examples. While it is too early to assess the
impact of these centers, given their recent creation, the state commitment of authority
and resources towards these centers lends legitimacy and expectation to efforts that
primarily has been conducted on a voluntary basis (e.g., patient safety coalitions).
State patient safety centers may play an active role in generating the systemic changes
cited as key to enhancing patient safety.