Medical Malpractice: The Role of Patient Safety Initiatives
CRS Report for Congress
The Role of Patient Safety Initiatives
Updated July 14, 2006
Analyst in Health Insurance
Domestic Social Policy Division
Amanda Kay Sarata
Analyst in Genetics Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
The Role of Patient Safety Initiatives
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 consideration in malpractice
discussions 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. For example, S. 544, the Patient
Safety and Quality Improvement Act of 2005, encouraged the voluntary reporting and
analysis of medical error data. S. 544 became P.L. 109-41 on July 29, 2005.
However, medical liability issues are addressed in other legislation — specifically,
H.R. 5/S. 354, the Help Efficient, Accessible, Low-Cost, Timely Healthcare
(HEALTH) Act of 2005, S. 22, the Medical Care Access Protection Act of 2006, and
S. 23, the Healthy Mothers and Healthy Babies Access to Care Act.
The separation of patient safety concerns from medical malpractice issues has
not always been the case. Several states have passed legislation that included
provisions that addressed both malpractice and patient safety issues. Research
studies have explored the links between the two issues, and a few bills introduced
during the 109th Congress, such as S. 1337 and S. 1784, address those links.
Therefore, it is appropriate and timely to reconsider these issues collectively, and
revisit 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 on the quality of care provided continues
to be an open question. Individual initiatives have resulted in promising outcomes,
but the overall impact of these efforts has been mixed. To some degree, this is the
case 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.
Patient Safety and Medical Errors.....................................3
The Institute of Medicine Report..................................4
Patient Safety Initiatives........................................4
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
Reporting of Medical Errors....................................10
Lessons from the Airline Industry............................10
Mandatory vs. Voluntary Reporting..........................11
Examples of Health Care Reporting Programs..................11
Clinical Standards in Hospital Settings............................12
IHI’s 100,000 Lives Campaign:
A Hospital Quality Initiative............................13
Proposed IT Initiatives.....................................13
Technology Implementation Considerations....................14
Impact of Patient Safety Programs....................................15
Selected Results from the Field..................................15
Tracking and Reducing Medical Errors........................15
Publicizing Hospital Performance Data........................16
Disclosing Medical Errors to Injured Patients...................16
Using Information Technology in Health Care Delivery...........17
Barriers to the Adoption of Patient Safety Programs..................17
Liability and Professional Concerns..........................18
Lack of Patient Safety Research..................................19
Federal and State Patient Safety Activities.............................19
Federal Agency Activities......................................21
State Patient Safety Centers.................................24
The Role of Patient Safety Initiatives
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 has centered on limiting the damage
awards in malpractice suits. Some attention has been given to insurance market
reforms. A third, related area that has received less consideration 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 incorrect2
medical treatment or the failure of a specific treatment to achieve the intended result.
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 considered during the 109th Congress has been no exception. S. 544, the
Patient Safety and Quality Improvement Act of 2005, established a system for the
voluntary submission and analysis of medical error data. Similar to other medical
error reporting bills in recent years, it prohibited use of error data in administrative,
civil, and criminal proceedings. S. 544 became P.L. 109-41 on July 29, 2005.
However, medical liability issues are addressed in other legislation — specifically,
H.R. 5/S. 354, the Help Efficient, Accessible, Low-Cost, Timely Healthcare
(HEALTH) Act of 2005; S. 22, the Medical Care Access Protection Act of 2006; and3
S. 23, the Healthy Mothers and Healthy Babies Access to Care Act. All of these
bills focus on tort reform as the solution to increasing malpractice premiums.4
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 For more details about legislative proposals to address malpractice insurance concerns, see
CRS Report RL33358, Medical Malpractice: An Overview, by Bernadette Fernandez and
4 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.
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), which included provisions not only limiting damage awards
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 interest in patient safety
and observations by some that the nation is in the midst of its third malpractice
insurance “crisis,” some federal and state legislators have developed proposals to
address these issues. 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.5 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.6 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 that target the legal system, such as
malpractice tort reforms.7
5 P.C. Weiler, et al., A Measure of Malpractice, 1993.
6 G.B. Hickson, et al., “Development of an Early Identification and Response Model of
Malpractice Prevention,” Law and Contemporary Problems, winter 1997, p. 9. (Hereafter
cited as Hickson.)
7 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.
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
litigation.8 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.”9 Indeed, the
variety of disciplines involved in this debate (i.e., medicine, insurance, law,
government) speaks to the complexity of the issues. It follows that any meaningful
discussion about them necessitates a thorough analysis, including an analysis of
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 sample10
of 23 California hospitals in 1974. That analysis found that nearly 5% of
hospitalizations 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. 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 medical11
injury. He noted that this was equivalent to “three jumbo-jet crashes every 2 days.”
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.
8 L. Landro, “The Informed Patient: Some Hospitals Offer New Service: Helping Patients
Complain,” Wall Street Journal, June 19, 2003.
9 L.L. Leape, et al., “Promoting Patient Safety by Preventing Medical Error,” Journal of the
American Medical Association, vol. 280, no. 16, p. 1445.
10 For more detailed historical information, see P.M. Danzon, Medical Malpractice: Theory,
Evidence, and Public Policy, 1985.
11 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.
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.12 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
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 could 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 that 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 debate.
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-wide13
analysis, and public disclosure of information. 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 report endorsed many of the IOM’s recommendations and14
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
12 Institute of Medicine, To Err is Human: Building a Safer Health System, 1999, can be
found at [http://www.nap.edu/books/0309068371/html/]. (Hereafter cited as IOM, “To Err
13 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.
14 Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and
Their Impact can be found at [http://www.quic.gov/report/].
number of federal agencies, and developing new labeling standards to prevent
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.15 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.16
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, and17
negligent physicians may not be held accountable through the legal system.
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.”18 The
premise underpinning defensive medicine is that the fear of liability and the potential
negative outcomes associated with malpractice claims lead physicians to administer
additional health care treatments or avoid high-risk services primarily to reduce their
liability risk. The implication is that defensive medicine results in either an increase
in overall spending for health care that may not be medically necessary, or a decrease
in access to certain services or for certain patients. Detractors suggest that the growth
of cost-conscious managed care has limited physicians’ ability to provide care that
15 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
16 The latest survey results can be found at [http://www.leapfroggroup.org/home].
17 M.M. Mello, “Malpractice Liability and Medical Error Prevention: Strange Bedfellows?,”
18 U.S. Joint Economic Committee, “Liability for Medical Malpractice: Issues and
Evidence,” May 2003. Available online at [http://www.house.gov/jec/].
provides marginal medical benefit. 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 malpractice premiums or prior
experience of being sued.”19 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
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.20
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 online.
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
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
19 Mello, “Malpractice Liability.”
20 Physicians who serve in the military, Department of Veterans Affairs, Public Health
Service, the National Institutes of Health, and other federal agencies are regulated by the
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
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, they say, 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.21
National Practitioner Data Bank. Established under the Health Care
Quality Improvement Act of 1986 (P.L. 99-660) 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: medical malpractice payments; actions taken
by a state Board of Medical Examiners to suspend or revoke a practitioner’s license;
and 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
Some legislators and consumer groups have advocated for 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 Government22
Accountability Office (GAO) report, under-reporting may be a severe problem, and
so the completeness and accuracy of the NPDB information are an open 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, they say, a simple comparison of
21 The information is available for a fee and can be found at [http://www.docinfo.org].
22 U.S. General Accounting Office, “National Practitioner Data Bank — Major
Improvements Needed to Enhance Data Bank’s Reliability,” Nov. 2000.
malpractice payments made by physicians in different specialties would be
misleading, 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 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, some assert, 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 and for certain specialities, providers may believe they are being asked
to disclose sensitive information with no guarantee of legal, administrative, or
professional protection. 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 that have posted disciplinary actions on the
Internet are reporting that they have seen no negative impact from making this
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 that 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. 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-
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,
D.C. National Academy Press, 2003). The report can be found at [http://www.nap.edu].
authorized the establishment of the Federal Agency for Health Care Policy and
Research (AHCPR).25 AHCPR ceased internal development of clinical practice
guidelines in 1996, and now — as the reauthorized Agency for Healthcare Quality
and Research — supports external researchers in the creation and dissemination of
evidence-based medical care.
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. One study found that
U.S. physicians follow recommended “best practices” for diagnosis and treatment of
adults 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 Internet technology 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 physicians believe that other
physicians are the most appropriate individuals to assess the quality of care delivered,
and provide counseling or additional 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 that 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 Hickson, p. 26.
29 QIOs are successors to the Peer Review Organization (PRO) program established by
Congress under the Omnibus Budget Reconciliation Act of 1986. Additional information
may be found at [http://www.ahqa.org/pub/media/159_766_2687.cfm].
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 proposed, such
as reporting hospital performance, disseminating clinical protocols, and 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). The JCAHO 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.
Reporting of Medical Errors
Patient safety studies and initiatives 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.30
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 and31
Space Administration (NASA). The ASRS is a system for reporting “near misses;”
that is, incidents that do not result in accidents but nonetheless violate 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 more than 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 that
result in passenger injury or aircraft damage. Serious aviation accidents are
investigated by the National Transportation Safety Board under a different system.
Moreover, pilots have extra incentive to perform flawlessly since a major mistake
puts them in as much immediate danger as their passengers.
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
30 For additional information about communication between patients and providers see
“Health Care at the Crossroads: Strategies for Improving the Medical Liability System and
Preventing Patient Injury,” 2005.
31 Additional information on ASRS can be found at [http://asrs.arc.nasa.gov/main_nf.htm].
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
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
Mandatory vs. Voluntary Reporting. There are many ideas among
stakeholders regarding the design of a health care reporting system, including who
should report and what they should report. A key area of discussion is whether a32
reporting system should mandate participation or be voluntary.
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 that are caused or exacerbated by poorly designed health care delivery
According to the IOM, voluntary reporting systems play a “valuable role in33
encouraging improvements in patient safety.” Experience from ongoing voluntary
reporting efforts have shown that such systems are helpful in identifying errors that
occur on such an infrequent basis that they would be difficult to detect by any one
single health organization, and error trends or patterns that allude to system problems
that may affect all health care organizations. 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 Health Care Reporting Programs. Both private and public
entities have implemented patient safety reporting programs. For example, in 1996
JCAHO implemented its Sentinel Event Policy (SEP).34 This 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, and track the effectiveness of those strategies. The policy also
encourages health care organizations to share their findings with JCAHO, in order
for it to pass on those “lessons learned” to others. As of April 2006, JCAHO has
released 36 alerts that describe different types of serious medical events and suggest
32 “Medical Mistakes,” CQ Researcher, vol. 10, no. 7.
33 IOM, “To Err is Human,” p. 104.
34 Additional information about JCAHO’s Sentinel Event Policy can be found at
[ ht t p: / / www.j caho.or g/ accr e di t e d+or ga ni za t i ons/ s ent i nel +eve nt / s ef act s.ht m] .
ways to prevent them. The alerts also include statistics on the prevalence of these
medical events, but do not name specific hospitals.
With respect to the states, 28 have passed legislation or issued regulations
mandating the reporting of adverse events or medical errors in hospitals.35 The
reporting requirements vary widely. For instance, state mandates differ in what
health facilities are required to do with reported information: review reports about
medical violations, share information with patients, disseminate evidence-based,
error-prevention protocols, etc. 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 analyses and use the findings in their role as regulator.36
“Honesty Policies”. While most of the attention paid to better
communication has centered on reporting systems, a few health care entities have
implemented programs that directly engage individuals injured by medical errors.
“Honesty policies” have been instituted in a small minority of hospital and health
care systems 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.37
Providers typically resist disclosure of adverse medical events. 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 health 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 instance, AHRQ developed a set of Quality Indicators (QIs) to
measure the level of quality associated with the medical care being delivered in
hospitals. One of the components that make up the QIs is a set of Patient Safety
Indicators (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 PSIs to assess patient safety at their facilities.
35 States with mandatory reporting requirements: CA, CO, CT, FL, KS, IL, IN, ME, MD,
MA, MN, MO, NE, NV, NH, NJ, NY, NC, OH, PA, RI, SC, SD, TN, TX, VA, WA, and
WY. A. McKinley, “Medical Errors and Patient Safety,” HPTS Issue Brief, Dec. 31, 2005.
(Hereafter cited as McKinley, “Medical Errors and Patient Safety”)
36 According to National Academy for State Health Policy staff.
37 C. Liebman and C. Hyman, “A Mediation Skills Model to Manage Disclosure of Errors
and Adverse Events to Patients,” Health Affairs, July/Aug. 2004.
IHI’s 100,000 Lives Campaign: A Hospital Quality Initiative. In
December 2004, the Institute for Healthcare Improvement (IHI) launched a major
effort to save 100,000 lives in American hospitals over an 18-month period of time.
Dr. Donald Berwick, President and CEO of IHI, stated that this significant outcome
could be achieved easily if hospitals focused on implementing only six evidence-
based interventions that are known to improve health care. The six quality
improvement interventions that are a focus of the 100,000 Lives Campaign include
the deployment of rapid response teams, prevention of adverse events, improved care
for heart attacks, prevention of surgical site infection, prevention of central line-
associated infections, and prevention of ventilator-acquired pneumonia. Hospitals
that chose to participate in the 100,000 Lives Campaign had to commit to
implementing one or more of these six interventions.
The 100,000 Lives Campaign hoped to enroll 2,000 hospitals in its effort, but
to date has enrolled more than 3,000 hospitals (this represents about 75% of all
hospital beds in the United States). IHI touted its campaign as successful, and
announced on June 14, 2006, that it had surpassed its goal of saving 100,000 lives
by 22,300. Key components of this campaign include “node” hospitals, which lead
the initiative at the regional or state level; national partners, which provide the
initiative with visibility and exposure; and “mentor hospitals,” those hospitals that
have demonstrated success with a specific intervention and therefore act as mentors
to other hospitals by sharing what they have learned. Participation in the campaign
was entirely voluntary, no financial incentives were provided, and no regulatory
mandates were leveraged to achieve either participation or cooperation.38
Another area on which a great deal of attention is focused is information
technology (IT). Many observers believe that the health care system 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 thest
Quality Chasm: A New Health System for the 21 Century, concluded that IT’s role
in the future of health care delivery is key, and the automation of health care39
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
A number of public and private-sector organizations, to varying degrees, have
incorporated IT into their policies, programs, and operations. For example, President
38 Additional information about the 100,000 Lives Campaign may be accessed at
[ h t t p : / / www.i h i .or g/ IHI/ Pr ogr a ms / Ca mpa i gn/ ] .
39 Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st
Century, 2001, can be found at [http://www.nap.edu/books/0309072808/html/].
Bush in his 2006 State of the Union address expressed his desire to reduce medical
errors through wider adoption of information technologies. Moreover, included in
the President’s FY2007 budget request is $169 million for health IT initiatives to
improve quality and reduce errors, among other objectives.40
For more than 20 years, the Department of Veterans Affairs (VA) has developed
and operated the Veterans Health Information Systems and Technology Architecture
(VISTA). VISTA is an integrated health information system that incorporates
diverse functions ranging from managing patient records to providing decision-
support tools to handling billing. It can be accessed at each of the VA’s 1,400
facilities. According to the VA, such connectivity and use of performance measures
have led to both increases in efficiency and reductions in medical errors.41
The Food and Drug Administration (FDA) issued a final rule on February 26,
in order to reduce the probability of errors that 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.42
A related strategy to reduce adverse drug events comes from the private-sector
Leapfrog Group. One of the three measures that 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. The latest survey
results revealed that half of CIOs cited reduction of medical errors and promotion of
patient safety as one of their top priorities for 2006.43
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 requires hospitals to spend an estimated $7-plus billion on necessary
40 “Health,” Office of Management and Budget (OMB) website, at [http://www.whitehouse.
41 Additional information about VISTA may be found at [http://www.innovations.va.gov/].
42 FDA, press release, “HHS Announces New Requirements for Bar Codes on Drugs and
Blood to Reduce Risks of Medication Errors,” Feb. 25, 2004, can be found at
[ h t t p : / / www.f d a.go v/ bbs/ t opi cs/ n ews/ 2004/ hhs_022504.ht ml ] .
43 “17th Annual HIMSS Leadership Survey, CIO Results” Feb. 13, 2006, at
[http://www.himss.org/ 2006surve y/ docs/ Healthcare_CIO_finalreport.pdf].
equipment.44 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. To some degree, this is the case 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.
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 that included how health care facilities track and record
medical errors, and discussed how such information may be used to increase patient45
safety. 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).
For instance, to assist hospital efforts to enhance patient safety, AHRQ developed a
survey, with both private and public partners, to measure “organizational conditions
that can lead to adverse events and patient harm.”46
44 “FDA: Proposes Bar Codes for Medications, New Error Reporting System,” American
Health Line, Mar. 14, 2003.
45 AHRQ, Interim Report to the Senate Committee on Appropriations, AHRQ Publication
No. 04-RG005, Dec. 2003, can be found at [http://www.ahrq.gov/qual/pscongrpt/].
46 C. Clancy, Testimony before the Subcommittee on Health Committee on Energy and
Commerce, June 9, 2005, at [http://www.ahrq.gov/news/test60905.htm].
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 the47
common concerns involved in such efforts. 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
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 reduction in the number of claims and smaller claim
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 assert that VA patients generally are older men with finite
resources; individuals who may have limited expectations and a lower-than-average
47 J.H. Hibbard, J. Stockard, and M. Tusler, “Does Publicizing Hospital Performance
Stimulate Quality Improvement Efforts?,” Health Affairs, vol. 22, no. 2.
inclination to sue.48
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 that allows
institute staff to remotely monitor cardiac patients at each of the system’s care
Specific IT initiatives also have enhanced patient safety. For instance, one study
found that the rate of serious medication errors fell more than 50% when49
computerized prescribing systems were used. Yet, despite the enthusiasm
expressed by some experts for the use of IT in health care, the adoption of such
technology has progressed slowly, especially in smaller medical settings. For
example, “more than 90 percent of medical practices with fewer than 50 doctors do50
not make significant use of IT.”
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. Some say medicine is a
conservative discipline that 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 may be 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.51
Limited Resources. There are also resource issues contributing to the lack
of progress in conducting patient safety efforts. The cost of investing in equipment,
48 A.W. Wu, “Handling Hospital Errors: Is Disclosure the Best Defense?,” Annals of
Internal Medicine, vol. 131, no. 12.
49 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.
50 G. Gross, “Lack of Standards Hinders Electronic Health Records,” IDG News Service,
Jan. 10, 2005, at [http://www.itworld.com/Tech/2987/050110healthstandards/pfindex.html].
51 M.N. Marshall, P.G. Shekelle, S. Leatherman, 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.
staff, and supplies are of paramount concern.52 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 does not take into account medical error rates
or 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 individual
initiatives to address the financial feasibility concerns expressed by health care
providers. For example, in April 2003, a coalition of providers, plans, purchasers,
and others launched “Bridges to Excellence,” whose mission is to reward high-
quality health care.53 In the public sector, HHS announced on July 10 of that same
year the launch of a demonstration that would provide bonuses to hospitals that
perform well on selected quality-of-care standards.54 More recently, S. 1932, the
Deficit Reduction Act of 2005, includes provisions for the Secretary of HHS to
develop a plan for value-based purchasing under the Medicare program beginning in
FY2009.55 These initiatives are indicative of the growing interest in pay for
performance in health care.56
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
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.
52 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
53 Additional information may be found at [http://www.bridgestoexcellence.org/bte/].
54 Additional information may be found at the Centers for Medicare and Medicaid Services
website, Premier Hospital Quality Incentive Demonstration, at [http://www.cms.hhs.gov/
HospitalQualityInits/35_HospitalPremi er.asp#T opOfPage].
55 On Feb. 8, 2006, S. 1932 became Public Law 109-171. For more information, see CRS
Report RL33251, Side-by-Side Comparison of Medicare, Medicaid, and SCHIP Provisions
in the Deficit Reduction Act of 2005, by Karen Tritz, Sibyl Tilson, Julie Stone, Chris L.
Peterson, Jennifer O’Sullivan, Paulette C. Morgan, Elicia J. Herz, Jean Hearne, Jim Hahn,
April Grady, Hinda Chaikind, and Evelyne P. Baumrucker.
56 A pay-for-performance (P4P) or value-based purchasing payment system is one where at
least some portion of the payments is based on performance assessed against a defined
measure. While most of the current discussions about P4P in health care address quality-
based measures, performance metrics can target any of a number of variables including
profitability, volume, or customer or patient satisfaction. The terms “merit” and “bonus pay
systems” also describe similar arrangements.
Therefore, individual practitioners and hospitals remain cautious about implementing
programs that 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 that took into account the
progress that had already been made at individual institutions.57
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.”58 To illustrate, the $84
million requested in the President’s FY2007 budget to support AHRQ’s patient
safety efforts is equivalent to the single largest investment in this area by the federal
government. However, that appropriation amounted to less than one-half of 1% of
the comparable budget request 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.
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 latter 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, Congress passed a number
57 J.H. Powell, “Hospitals Thwart Ratings Plan,” Boston Herald, Oct. 29, 2001.
58 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, July 24, 2002, pp. 503-504.
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.59
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 report.
Several patient safety bills were introduced in the 106th Congress to address the
issues raised in the IOM Report. Many 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 reauthorized as AHRQ) to
support medical errors research.60 Most of the patient safety legislation first
introduced in the 106th Congress was reintroduced in the 107th. Once again, not
much legislative action took place.
During 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 and enjoyed broad bipartisan support. H.R. 663
proposed the establishment of a voluntary reporting system and provided civil and
administrative protections for certain types of documents and communications
termed “patient safety work products.” On March 12, 2004, the House passed H.R.
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 22, 2004, the Senate incorporated S. 720
in H.R. 663 as an amendment, and passed H.R. 663 by unanimous consent.
During the first session of the 109th Congress, Senator Jeffords introduced S.
544, the Patient Safety and Quality Improvement Act of 2005. S. 544 was identical
to the Senate-passed patient safety bill, S. 720. It established a system for the
voluntary submission and analysis of medical error data, and prohibited the use of
patient safety data in administrative, civil, and criminal proceedings. The Senate
amended and passed S. 544 unanimously on July 21, 2005. Six days later, the House
voted overwhelmingly to pass the bill. S. 544 became P.L. 109-41 on July 29,
59 For additional information, see U.S. Congress, House Committee on Ways and Means,
Medical Malpractice, committee print, 101st Cong., 2nd sess., Apr. 26, 1990, WMCP 101-26.
60 “Congress Clears Bill to Help Women With Cancer; No Progress on Medical Errors,”
While the majority of patient safety and medical malpractice bills address
problems related to only one of these issues, a few bills have included provisions that
address both issues. For example, S. 1337 would authorize the HHS Secretary to
award grants to states to develop, implement, and evaluate alternatives to tort
litigation for the purposes of resolving malpractice claims and utilizing patient safety
data. Each state must demonstrate how the alternative approach encourages prompt
and fair resolution of malpractice claims, promotes disclosure of medical errors,
increases patient safety, and preserves access to medical malpractice insurance.
Another bill, S. 1784, would establish the Office of Patient Safety and Health Care
Quality to administer the National Medical Error Disclosure and Compensation
(MEDIC) Program. This new federal program would analyze information submitted
by program participants about medical errors and patient safety events, provide grants
for the development and implementation of programs to disclose medical errors to
patients, and require program participants to offer to negotiate with individuals
injured by medical errors for some level of compensation. The bill also includes
provisions for a number of separate studies to analyze provider accountability within
the health care system, factors related to medical liability premiums, and cases that
were not negotiated through the program. A couple of other bills also introduced
during the 109th Congress (H.R. 3359 and H.R. 3378) use a comprehensive approach
that addresses multiple issue areas, such as tort reform, mediation, insurance reform,
medical errors reporting, and physician supply.
Federal Agency Activities
The Secretary of Health and Human Services (HHS) was charged with
promulgating rules pursuant to the Patient Safety and Quality Improvement Act of
2005 (P.L. 109-41). This task was given to the Agency for Healthcare Research and
Quality (AHRQ) within HHS, and specifically to the Center for Quality Improvement
and Patient Safety within AHRQ. In March 2006, AHRQ held a series of public
meetings to inform its rulemaking process. These meetings solicited feedback from
the public on specific topical areas, including provider-patient safety organization
(PSO) relationships, contracts and disclosures (March 8, 2006); the operation of a
component PSO62 (March 13, 2006); and security and confidentiality issues (March
16, 2006). Although the meetings specifically asked for comments relating to these
topics, participants were generally encouraged to provide comments on any issue they
believed was relevant to the rulemaking process. A broad range of stakeholders was
represented at the meetings, with an average of 200 participants at each meeting.63
The first meeting invited comments on provider-PSO relationships, disclosures,
61 For additional information about S. 544, see CRS Report RL31983, Health Care Quality:
Improving Patient Safety by Promoting Medical Errors Reporting, by C. Stephen Redhead.
62 A component PSO is a Patient Safety Organization that is a component of another
organization, for example, a hospital.
63 Transcripts of these meetings are available by contacting Eileen Hogan at AHRQ
and contracts.64 The Patient Safety and Quality Improvement Act provides for
extensive privilege and confidentiality protections for certain patient safety
information, deemed patient safety work products. Specifically, information is
afforded these protections if it is considered to be existing within a Patient Safety
Evaluation System (PSES).65 In other words, this information is considered to be a
patient safety work product if it is created within the boundaries of a PSES. For this
reason, AHRQ needs to provide clear guidance as to the boundaries and scope of a
PSES to make clear what information falls under its aegis and therefore is protected.
In addition, the statute requires entities pursuing certification as a PSO to provide the
Secretary with relevant information regarding their existing relationships with health
care providers that might constitute a conflict of interest, and AHRQ was interested
in gathering information from the public regarding what type of relationships
specifically would trigger concerns about an entity’s ability to perform independently
as a PSO.
The second meeting focused on the issues arising during the operation of a
component PSO (meaning an entity that is a component of another organization).
Specifically, the statute has additional security-related requirements for component
PSOs to ensure that privacy of the patient safety work products it collects is not
compromised. In particular, these requirements help to make certain that protected
information is not shared with the parent organization.
Finally, the third meeting solicited comment on broader issues relating to
security and confidentiality. Specifically, the statute allows for certain exceptions to
the protection of information, and AHRQ was interested in learning more about how
64 A patient safety organization is defined by law to mean “a private or public entity or
component thereof that is listed by the Secretary ...” The criteria for certification of an
entity as a PSO are listed below:
(A) The mission and primary activity of the entity are to conduct activities that are to
improve patient safety and the quality of health care delivery.
(B) The entity has appropriately qualified staff (whether directly or through contract),
including licensed or certified medical professionals.
(C) The entity, within each 24-month period that begins after the date of the initial listing
under subsection (d), has bona fide contracts, each of a reasonable period of time, with
more than one provider for the purpose of receiving and reviewing patient safety work
(D) The entity is not, and is not a component of, a health insurance issuer (as defined in
(E) The entity shall fully disclose:
(i) any financial, reporting, or contractual relationship between the entity and any
provider that contracts with the entity; and
(ii) if applicable, the fact that the entity is not managed, controlled, and operated
independently from any provider that contracts with the entity.
(F) To the extent practical and appropriate, the entity collects patient safety work product
from providers in a standardized manner that permits valid comparisons of similar cases
among similar providers.
(G) The utilization of patient safety work product for the purpose of providing direct
feedback and assistance to providers to effectively minimize patient risk.
65 A patient safety evaluation system is defined as “the collection, management, or analysis
of information for reporting to or by a patient safety organization.”
this would affect existing clinical operations. In addition, since it is possible that a
PSO might receive information about events that are outside of any contractual
relationship it has with a provider, AHRQ wanted feedback on how PSOs should
handle such information. The agency also was interested in receiving comments
relating to standards for de-identifying data and securing identifiable health
According to AHRQ, the information generated through these meetings has
been analyzed by the agency but is not publicly available. The comments received
highlighted several important issues, which may be helpful to the agency as it moves
forward. AHRQ is formulating a draft rule, and expects to release it in the immediate
future. As this will be AHRQ’s first operational program, and since the legislation
raises a plethora of policy issues, a substantial amount of energy is being directed
toward this effort. More information about these meetings can be found on AHRQ’s
website at [http://www.ahrq.gov/about/pso06.htm].
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.66
On the issue of patient safety specifically, many 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. However, during the 2005
legislative sessions, states made limited progress. Three states (Kentucky, Virginia,
and Wyoming) “enacted legislation to address medical errors and to improve patient
safety in the first quarter of 2005.”67
As previously noted, 28 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
purpose. For example, Washington requires the reporting of medication-related
errors, but New Jersey requires the reporting of “serious preventable adverse events.”
Connecticut requires medical facilities to contract with patient safety organizations
66 According to National Academy for State Health Policy staff.
67 McKinley, “Medical Errors and Patient Safety,” p. 5.
for data collection and recommendations on improving patient safety. In contrast,
New York requires hospitals to report infection rates, which are included in an annual
report published by the state Health Department.
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 bills in 2002 and
and patient safety enhancement. According to Governor Rendell, the comprehensive
approach was an attempt to address concerns about malpractice insurance and
medical safety.68 A couple of other states passed or debated similar bills that also
linked those issues.
State Patient Safety Centers. A budding movement in the states is the
creation of state patient safety centers. The common purpose of these entities is to
promote patient safety efforts within the state. Approaches, which vary by state,
include 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. While it is
too early to assess the impact of these centers, the state commitment of authority and
resources towards these centers lends legitimacy and expectation to efforts that
primarily had been conducted on a voluntary basis (e.g., patient safety coalitions).
State patient safety centers may yet play an active role in generating the systemic
changes cited as key to enhancing patient safety.69
68 “Pa. Governor Unveils Med-Mal Liability Reform Plan” Insurance Journal, June 2003.
69 J. Rosenthal and M. Booth, “State Patient Safety Centers: A New Approach to Promote
Patient Safety,” National Academy for State Health Policy, Oct. 2004.