Copyright 2000 Federal News Service, Inc.
Federal News Service
February 9, 2000, Wednesday
SECTION: PREPARED TESTIMONY
LENGTH: 5758 words
HEADLINE:
PREPARED TESTIMONY OF THE HEALTH CARE LIABILITY ALLIANCE
BEFORE
THE HOUSE COMMERCE COMMITTEE HEALTH AND ENVIRONMENT
SUBCOMMITTEE, AND THE OVERSIGHT AND INVESTIGATIONS SUBCOMMITTEE AND THE
HOUSE VETERANS' AFFAIRS COMMITTEE HEALTH SUBCOMMITTEE
SUBJECT - "THE FINDINGS IN A REPORT FROM THE INSTITUTE OF
MEDICINE ON MEDICAL ERRORS"
BODY:
Executive
Summary
The Institute of Medicine (IOM) Report makes a significant
contribution to the efforts members of the Health Care Liability Alliance (HCLA)
and others in the health care field are making to improve the quality of patient
care because it recognizes that:
a. the focus should be on systems, not
individuals, and that prevention of future errors is more important than
retrospective faultfinding;
b. reporting of adverse events is necessary
to prevent future errors; and c. reporting systems currently are not working
adequately because the tort litigation system discourages reporting of errors.
Because of its concern for the effect the tort system has on the quality
of care, HCLA welcomes the IOM Report. The IOM Report takes the nation a
significant step forward by recognizing that the tort system is a major barrier
to improving the quality of care. That underlying conclusion provides the basis
for meaningful federal tort reforms. The IOM Report recommends
expansion of the immunity and protection provided for peer review materials
although it inconsistently recommends that confidentiality not be provided for
reports of serious adverse events. The members of HCLA believe that efforts to
improve quality are not impeded by the absence of centralized reporting.
Barriers to reporting are raised by a lack of confidentiality and the waste,
randomness, and injustice of the tort litigation system. While the IOM Report
recognizes these barriers, it does not recommend cures for them. HCLA's
recommendations address the problems identified but not addressed by the IOM
Report.HCLA, while not agreeing with the conclusions of The Harvard Medical
Practice Study, does recognize the underlying premise of the study. Patient
safety and quality of care must be paramount in the health care system. We
should, as a health care system and as a society, endeavor to eliminate
avoidable injures. We must focus on what can be done to identify, reduce and
eliminate injuries.
HCLA recommends, therefore, that to promote
reporting and analysis of adverse event reports and to enable providers and
others to better collaborate on quality improvement efforts, Congress should:
a. Focus on doing only what is necessary, at the federal level, to
empower the health care providers to address this problem by allowing
appropriate information regarding adverse events to quickly reach the people in
the health care system who will use such information to improve patient safety.
b. Recognize that creation of a national center for collection of
adverse event reports will not yield its intended result -- a reduction in such
events.
c. Enact legislation providing confidentiality protection for
safety and quality reports and efforts, such as peer review.
d. Enact
into law the tort reforms embodied in HCLA's model bill already
proven successful in the MICRA legislation in California.
The IOM is to
be congratulated on its endeavors to improve the nation's health care system by
bringing its focus on the incidence of medical errors. The IOM Report clearly
identifies the obstacles to improving patient safety. HCLA supports the IOM
Report's conclusion that the current methods of dealing with medical errors are
counterproductive. HCLA believes a more direct approach is necessary. Federal
reform of the tort system is the sine qua non of that approach.
***************
Statement of the Health Care Liability Alliance
The Health Care Liability Alliance (HCLA) is a coalition of more than 30
organizations committed to reform of the health care litigation system to
enhance its fairness, timeliness, and cost-effectiveness. HCLA's members are
organizations and associations of physicians, hospitals, blood banks, health
device manufacturers, health care insurers, pharmaceutical manufacturers, and
biotechnology companies.
HCLA applauds the Chairman's timely leadership
in connection with the issue of patient safety. We appreciate the opportunity to
submit our views regarding the report of the Institute of Medicine (IOM)
entitled "To Err is Human: Building a Safer Health System." We look forward to
working with the Chairman, members of the Committee, and their staff as Congress
debates this important issue.
Because of its concern for the effect the
tort system has on the quality of care, HCLA welcomes the IOM Report. The Report
makes a significant contribution by recognizing that the tort system is a major
barrier to improving the quality of care. That underlying conclusion provides
the basis for meaningful tort reforms.
INTRODUCTION
The tort system as it now operates in this country increases health care
costs by forcing providers to practice defensive medicine and by imposing
inordinate litigation costs on the health care system. These costs are borne by
patients, people with insurance, people who are trying to buy insurance, people
who need care, and taxpayers--through higher health care costs, higher insurance
premiums, higher taxes, and reduced access to care.
The tort system does
not provide benefits that justify these costs. It does not carry out its
intended functions. It does not establish a rational standard of care. Findings
of liability, made in court with hindsight and with the benefit of leisurely
contemplation that rarely are possible in the actual delivery of care, often do
not provide an accurate standard of medical conduct. As one expert on the tort
system has summarized this situation, "The fundamental problem of tort
liability, especially in the areas of products liability and medical
malpractice, stems from the unpredictability of its imposition."1
This
retroactive, case-by-case, and arbitrary standard making has caused doctors to
practice defensive medicine-- to order medical procedures out of a perceived
need to have a defense available if there should be an adverse event. Cesarean
delivery rates provide one example.
Because juries
awarded large recoveries for birth injuries where obstetricians did not perform
a Cesarean section, doctors have performed them more often than they otherwise
would have. Cesarean rates rose from 4.5 per 100 births in 1965 to 24.1 in
1986.2
The essentially unlimited power of juries to award non-economic
damages results in verdicts that are not just and that when publicized whet the
appetite of trial lawyers and traumatize providers. In many cases, (enough to
engender disdain for the litigation system and fear on the part of the
provider), there is no logical or medical connection between the provider's
action and liability or between the injury and the amount of damages awarded.
The Harvard Study of hospital care in New York itself demonstrated that
the filing of claims was not correlated to negligence.3 In a follow-on study of
claims of malpractice filed by patients in the Study, several of the authors
concluded that "the severity of the patient's disability, not the occurrence of
an adverse event or an adverse event due to negligence, was predictive of
payment to the plaintiff."4 In other words, the amount patients recovered
through the tort system was a function of their health condition, not any
negligence by the health care system. The authors concluded more generally,
therefore, that "the standard of medical negligence performs poorly in
malpractice litigation."
The tort system thus presents a provider with
the random risk of catastrophic financial injury. This causes some providers to
quit practice and others to limit their practice, reducing patients' access to
care, particularly in inner-city and rural areas. Most of those who continue to
practice are forced to engage in defensive medicine. This results in more
medical interventions for patients, as the increased rate of Cesarean deliveries
demonstrates, thereby adding costs and putting patients at greater risk. It is
estimated that defensive medicine costs at least $50 billion
per year.
At the same time, the litigation system does not provide fair
and timely compensation for injured patients. They must wait on average 3 1/2
years for resolution of their claims by the litigation system. If they prevail,
they typically must give 33-60% of any recovery to their lawyers in contingency
fees. Only 28 percent of the amount spent to provide insurance coverage actually
goes to victims; the rest is spent in transaction costs and in operating the
tort litigation system.7 The tort system imposes a 72% tax on patients and
providers.
Because of the threatening and contentious climate it
creates, the litigation system, rather than protecting patients, is actually
impeding efforts to improve the quality of care. It makes it difficult for
providers to acknowledge mistakes. It deters open discussion of possible errors.
And it discourages providers from filing reports, seeking assistance, and
collaborating with other providers and experts to improve quality.
The
money spent on defensive medicine and litigation expenses could be better used
to improve the quality of care and access to it. The energy and focus that the
present system channels into litigation- related and litigation-induced actions
should be redirected into developing better quality control systems and
innovative ways of delivering care.
INSTITUTE OF MEDICINE REPORT
With one exception, the IOM Report avoids inflated rhetoric. The
exception is its statement that as many as 98,000 people may die annually
because of medical error. This figure is extrapolated in ways that are not
explained from 71 deaths that the Harvard Study of the medical records of 31,429
patients discharged from 51 New York hospitals in 1984 said were attributable to
negligence.8 This extrapolation has no scientific basis, as the authors of the
Study themselves have recognized.9
The Harvard Study, moreover, suffered
from methodological flaws, and its results have not been duplicated. The
reviewers who determined which records reflected negligence agreed in only 10%
of the cases. In an effort to confirm findings that rest on this shaky
foundation, a second set of reviewers examined a subset of 318 of the records.
Apparently they did not reach the same conclusions on individual records that
were attributed to the primary set of reviewers.10
The authors of the
Harvard Study also applied their methodology to patients in Colorado and Utah
hospitals in 1992. Extrapolating the results of this study, the authors
concluded that 44,000 deaths were caused nationwide by medical error. The IOM
Report finds this, and the unexplained figure of 98,000 deaths, to represent a
range.11 The more recent study, however, could equally be seen as an indication
that health care improved in the 8 years after the New York study, that better
care is provided in Colorado and Utah, or, since the results of the Harvard
Study could not be duplicated, that the parameters of the Study are vague and
the methodology is flawed.
It is not our purpose here to discuss the
weaknesses of the Harvard Study or the exaggerated extrapolations that have been
made from it. Patient safety and quality care should not be a numbers game. We
should, as a health care system and as a society, endeavor to eliminate
avoidable injuries. In doing so we must remember, as the Harvard /12 Study
reminds us, medical intervention is inherently risky and is provided by people.
People are only human, and the title chosen for the IOM report reflects
the reality this presents; "To Err is Human." Because we are dealing with
medical intervention by human beings, we must focus on what we can do together
to reduce the number of unnecessary injuries suffered during the delivery of
health care services.
The IOM Report makes a vital contribution to this
effort by its recognition and discussion of the three interrelated factors that
now impede efforts to improve patient safety.First, it emphasizes that the
problem is not "bad apples,"13 although there are some "bad people" and they
must be weeded out. Mistakes are often caused, or are not prevented, by system
(both technical and organizational) failures. As the Report suggests, because
providers are only human, they need systems to help them avoid mistakes; but we
cannot let reliance on systems dull the special intelligence that humans posses
or lull them into lethargic complacency.
The focus must be on developing
systems that avoid future mistakes and not on attempting to pin blame for past
conduct on an individual. This important observation leads the Report to balance
public policy in favor of error prevention and away from faultfinding: "When an
error occurs, blaming an individual does little to make the system safer and
prevent someone else from committing the same error."14 "Although a punitive
response may be appropriate in some cases (e.g., deliberate malfeasance), it is
not an effective way to prevent recurrence."15
Secondly, the Report
emphasizes the need to report information about adverse events or potential
adverse events in order to identify patterns of conduct that threaten safety and
to assess the success of corrective actions. It correctly recognizes that
reporting is essential to the primary goal of prevention. The Report provides a
comprehensive summary of the numerous and varied reporting systems that are
currently in effect.
Thirdly, and most importantly, the Report
recognizes that there is a critical and common element or impediment that
prevents all the reporting systems, regardless of how they are structured, from
collecting the information they need. That impediment is the tort system.
Participants and witnesses to an adverse event are reluctant to report
it (even if required by law to do so) out of fear that doing so will trigger or
support a tort claim. The irrationality of the litigation system and the
randomness of its results trigger a defensive reaction. Fear of being enmeshed
in that system, even if one is ultimately found not to be liable, deters
reporting.
As the Report concludes, "Patient safety is also hindered
through the liability system and the threat of malpractice, which discourages
the disclosure of errors. The discoverability of data under legal proceedings
encourages silence about errors committed or observed."16 As a result, it finds
"All reporting systems, whether mandatory or voluntary, are perceived to suffer
from underreporting. Indeed, some experts assert that all reporting is
fundamentally voluntary since even mandated reporting can be avoided .... The
volume of reporting is influenced by more factors than simply whether reporting
is mandatory or voluntary .... One factor is related to confidentiality."17
"Thus," the Report concludes, "the prominence of litigation can be a substantial
deterrent to the development and maintenance of the reporting systems discussed
in this report."18 It is refreshing that the IOM Report recognizes this problem.
It is important to the debate that it does so. The tort system impedes efforts
to improve health care by deterring the reporting of data needed to make
improvements in the health care system. Recognition of this fact by The IOM
should provide the needed impetus for addressing this basic problem.
As the Report recognizes, the tort system deters reporting even
where confidentiality is promised. There is concern that confidential data will
leak. There is also fear that what is confidential today may not be protected
tomorrow. The Report cites the powerful example of the continuing political
pressure to "open up" the National Practitioner Data Bank.19 Providers are
concerned that the constant political pressure eventually will be successful,
leading to a breach not only of a particular data source but also inserting the
opening wedge for a more general release.
Confidentiality of adverse
event reports, therefore, is necessary to develop an effective reporting system
that will permit identification of safety problems and permit assessment of
remedial actions. But there is on-going concern that even confidential reports
will be fed into the litigation system--by leaks or by surrender to political
pressure to remove the confidentiality protection. Confidentiality of reports is
necessary to improve reporting, but it is not sufficient. The tort system also
must be reformed.
TWO REFORMS THAT ARE NEEDED
The findings of
the IOM Report, therefore, confirm the need for a combination of two reforms:
confidential protection for adverse event reports and a reformed tort system.
Confidential reporting
It is important that Congress act on the
findings of the Report by protecting the confidentiality of reports made of
adverse events or of problems that could lead to adverse events.
The
Report in several places emphasizes the need for reporting to be confidential.
It appears, in fact, to call for Federal legislation to protect confidentiality
of all reports although it also makes an inconsistent recommendation that would
deny confidentiality to reports of adverse events leading to serious injury. The
Report recommends Federal legislation to "extend peer review protections to data
related to patient safety and quality improvement that are collected and
analyzed by health care organizations for internal use or shared with others
solely for purposes of improving safety and quality."2x As the Report's
discussion of peer review protection reflects, the nature and the scope of the
current protection varies widely from state to state.21 Not only does the scope
of the protection afforded by each state differ greatly, but in some instances
the sharing of peer review materials with third parties engaged in health care
quality efforts, such as The Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), has been held to waive any confidentiality protection.22
Moreover, the efficacy of these state protections is further undermined by
uncertainty surrounding the application of the peer review privilege should the
parties be drawn into federal court. This occurs, for instance, in actions
brought under a Federal statute with related medical malpractice claims under
state law (i.e., pendent state claims).
As the Report recognizes, health
care providers must have confidence that the peer review privilege will be
applied with consistency and predictability if they are to come forward with
information regarding medical errors? The discussion in the Report focuses on
immunity and protection of peer review materials and deliberations from
discovery. In urging that the protection be expanded, the Report at a minimum
recommends that quality and safety information derived from reports or from
investigation (the main areas now protected in different ways by peer review
statutes) be protected from use in litigation and from public dissemination. The
information derived through the peer review process may involve the "most
serious adverse events"; thus this recommendation calls for the appropriate
confidential treatment of such information.
However, the Report also
says that such information should be available for public consumption and that
only reports of events other than the "most serious adverse events" should have
confidentiality protection.24 We discuss this misplaced, and internally
inconsistent, position below. The important fact is that the Report finds that
confidentiality is necessary for effective reporting and patient safety
improvements and recommends in, at least one place, across-the- board
confidentiality.
Tort reform
Even where
confidentiality would be provided, but particularly where it would not,
reporting and improvements in the health care system quality can best be
advanced by reforming the tort system to protect providers from random and
excessive judgments. HCLA urges Congress to enact the tort
reforms embodied in its proposed legislation which is modeled on the
MICRA reforms enacted in California in 1975.
These reforms would
preserve the ability of injured patients to obtain compensation for their
economic injury and to recover reasonable non- economic damages. They would: 1)
encourage non-judicial resolution of claims and ensure that plantiffs' lawyers
did not capture an excessive contingency fee from their clients; 2) prevent
plaintiffs from obtaining double recovery (collateral source rule); 3) limit
noneconomic damages to a reasonable amount ($250,000); 4)
require plaintiffs to bring any action in a reasonable time after the injury
occurs or is recognized (statute of limitations and statute of repose); 5)
protect any particular defendant from paying a larger percentage of any recovery
than is warranted by his/her conduct (joint and several liability).
Passage of these measures will restore a measure of balance to the tort
system, give providers more faith in the system, and therefore facilitate
reporting--which ultimately will result in greater patient safety.As the IOM
Report recognizes, patient safety is not adequately served by the present
system. If the tort system in its current state were adequately protecting
patient safety, the Report would not have been necessary. The tort system is not
only not the answer; it is the barrier to the enhanced quality systems that the
Report correctly finds are the best way to improve safety. The underlying, if
unarticulated, theme of the Report, therefore, is that tort
reform is necessary to improve the quality of health care in this
country.
ACTIONS THAT SHOULD NOT BE TAKEN
The Report correctly
concludes that the barrier to systems improvements in health care is not the
lack of reporting mechanisms but the tort-induced reluctance of participants to
provide data through the existing avenues. There is no indication that there are
not enough reporting requirements. The Report describes them comprehensively.
The need is to make the changes necessary to encourage more reporting, and for
the agencies and institutions to which reports are made to analyze the
information and act on them more vigorously.
HCLA questions, therefore,
whether any purpose would be served by adding new reporting requirements or
creating new agencies to collect or coordinate reports. In fact, adding new
reporting requirements would only distract attention from the need to make the
essential tort changes to support the existing reporting requirements.
No new reporting requirements without confidentiality
While
recognizing that the barrier to existing reporting requirements is a lack of
confidentiality and fear of the tort system, the Report does not address this
barrier, except in its recommendation that peer review protections be expanded.
Instead it recommends that mandatory reporting of serious adverse events
be expanded by federal statute, without corresponding confidentiality
protection. Indeed, while it offers a gesture toward the states' role, it would
make mandatory reporting a federal requirement in any state that did not on its
own come to the conclusion that mandatory reporting is needed.25 Although The
Report recognizes that the absence of confidentiality is impeding compliance
with existing reporting requirements, it would make mandatory reporting a
national requirement while providing no confidentiality protection.
The
Report would permit confidentiality protection only for voluntary reporting of
events that are not serious--where it is least useful. If an event results in
little or no harm, there may be less concern about tort litigation. The Report
offers confidentiality protection here, where it is worth less, but would deny
it in the serious cases, where it is important to elicit reporting. Recommending
confidentiality for voluntary reports is not a sufficient response to the
problem identified by the Report itself--that lack of confidentiality deters
reporting.
Drawing a line, moreover, on when reporting is
required and when it is confidential on the basis of whether the action resulted
in "serious" harm will bog down the health care system in line-drawing and hair-
splitting. What is serious harm? Who defines it? Suppose the event could have
had a serious harm if it had not been caught? How long is serious? Is an extra
day in a hospital serious? Is a false positive that leads to patient concern
serious? Suppose the patient was not able to understand the test result; is a
false positive serious in that case?26
Rather than trying to impose
reporting by regulation and mandates, and varying the protection for different
types of reports, Congress should provide protection for all safety and quality
reports, and for consideration of them. This is the best way to advance patient
safety efforts.
No centralization of safety efforts
It would be
both unnecessary and harmful to create the new Federal Center proposed in the
IOM Report. The Report envisages various roles for this new Center. HCLA
believes these are unnecessary and would actually detract from efforts to
improve patient safety.
The Report sees a need for the Center to
establish a "national focus to create leadership, research, tools, and protocols
to enhance the knowledge base about safety."27 The premise that only the
creation of a government Center can create a national focus and provide
leadership is disturbing.
As the Report indicates, efforts to enhance
patient safety are being undertaken in different ways by a variety of
individuals and institutions: insurers, manufacturers, providers, academic
institutions, trade associations, etc. It may look messy and confused, but the
pursuit of knowledge often is, particularly in an area as complex and varied as
the design and manufacture of health care products and the delivery of health
care.
Commissions, meetings, and public awareness can all contribute to
a national focus. So can efforts by political leaders, if conducted without
demagogy and finger pointing. A new Center is not necessary to do this. This
proposal is really symbolic; concern would be demonstrated by creating a new
Center and spending more money.
An approach based on centrally
developing and collecting safety- related data could in fact impair safety
research and promotion of safety activities. A centralized agency for safety
research could well become hitched to a particular view or approach,
subordinating all others. It is more effective for different people to try
different approaches.
Creating a "highly visible (governmental) center"
is likely not only to diminish the diversity of research and views but to
politicize patient safety. Once there is a "highly visible" government agency
tasked to provide leadership and develop research and recommendations, every
interest group will descend on it in an effort to gets its agenda adopted.
Congress will inevitably be drawn in. It would be far more effective, if more
research is needed, to provide funding to a variety of researchers on a
scientific, non-political basis.
The Report also has another role in
mind for the new Federal safety Center. It would not be limited to research. It
would receive and analyze reports (from the states)-apparently the mandatory
reports of "serious adverse events" discussed above. The Center would become a
national data bank for at least some kinds of reports. But it is unclear how the
information would be used and who would have access to it. The Center apparently
would "identify persistent safety issues that require more intensive analysis
and/or a broader-based response."28 In other words, it would use the data to do
more studying. But would the agency act on the information? To whom would it
give its findings?
What is needed is not central collection of
information, nor more analysis and dissemination. Needed information should be
given to those in a position, and with the most powerful incentive, to use it to
improve patient safety. Instead of funneling data through a centralized, and
possibly politicized, government agency, the focus should be on doing what is
necessary to get the information to those who will actually use it to improve
patient safety.
Hospitals need more information about errors that are
made there. Licensing boards need more information about their licensees. It is
far simpler, and more effective, to inform a device manufacturer that the
labeling is confusing than to report this to Washington. With this information,
manufacturers, providers, and insurers would have the greatest incentive and the
best ability to use it to improve safety.
Instead of creating a
centralized, nation-wide, government-led reporting system, we should focus on
doing what is necessary to get more information to the people on the front lines
of health care quality.
Compliance will be enhanced if reporters know
they are reporting to an entity that will use the information effectively. A
nurse is far more likely to report an error to her nursing supervisor or to
report a problem with a device to its manufacturer than to file a form destined
for a distant Federal bureaucracy. Health care providers are the people who are
most concerned with quality of care and patient safety. They are more personally
and directly concerned than is a distant government bureau. They strongly want
to avoid adverse events. They want to provide good care.
There is
another practical factor that must be considered. Providers function under
conditions of considerable stress. They are quite astute in distinguishing
between what is real and what is more government make-work. They are more likely
to report when they believe it will do good (particularly if they have
protections of confidentiality) than where they are told to fill out another
government-imposed form that seems to bear little or no relation to their real
world--patient care.Providers, manufactures, suppliers, employers who sponsor
health plans, and insurers, deal with each other and with various licensing and
quality institutions on an ongoing basis. They should be encouraged to report
potential or existing problems and discuss improvements among themselves. This
can best be achieved by protection of confidentiality for reports and
discussions, and by reform of the tort system. Requirements that they file
reports with a state agency for forwarding to Washington, D.C., will not
encourage reporting or enhance collaborative efforts to improve the quality of
care.
CONCLUSION
The IOM Report documents the obstacles to
greater patient safety efforts: the difficulties in securing more reporting that
result from the lack of confidentiality and the shadow cast by the litigation
system. But rather than addressing these problems, it recommends more reporting
(but without confidentiality) and centralizing the reporting system.
The
problem, however, is not a lack of centralized reporting; it is the barriers to
reporting and to safety-improvement measures posed by the tort system.
The problem is not a lack of reporting mechanisms, but a lack of assured
confidentiality and fear on the part of the people who would report that they
will be enmeshed in the litigation system.
The primary need is not more
data and more studies; it is for those in the field attempting to improve
patient safety to have confidence that cooperating in safety improvement
measures will not result in involvement in burdensome tort litigation.
The fears induced by the tort system cannot be resolved by expanding the
already unsuccessful requirements to report. The problems of the tort system
itself must be addressed.
The solution should not be centralized or
governmental; it should be private and dispersed. Medical errors, when they
occur, happen at the local level, and local solutions are best crafted to solve
local problems.
The quality of health care, consequently, can best be
improved by reforming the tort system to: 1) reduce the number of lawsuits, 2)
make the system more fair and efficient, and 3) reduce its costs. Reforms in
this direction would lessen the pressures to practice defensive medicine, lower
health care costs, and increase access to care. At the same time, a fairer and
less random tort system, and assurances of confidentiality, would reduce the
barriers to reporting and enhance the ability of the field to identify problems
and to make corrections.
FOOTNOTES:
1 Jeffrey O'Connell,
"Two-Tier Tort Law: Neo No-Fault & Quasi-Criminal Liability," 27 Wake Forest
Law Review 871 (1992).
2 Richard E. Anderson, "Billions for
Defense," Archives of Internal Medicine. 1999; 159:2401
3 Paul Weiler et
al., A Measure of Malpractice. Cambridge: Harvard University Press; 1993.
4 Troyen A. Brennan et al, "Relation Between Negligent Adverse Events
and the Outcomes of Medical- Malpractice Litigation," N Engl J Med 1996;
335:1963-7.
5 Ibid.
6 David Kessler and Mark McClellan, "Do
Doctors Practice Defensive Medicine," QJ Econ. 1996; 111: 353390.
7
Jeffrey O'Connell and C. Brian Kelly, The Blame Game. Lexington Books; 1987:127.
8 Berkeley Rice, "Do doctors kill 80,000 patients a year?" Medical
Economics. November 2 I, 1994; 1 (discussing extrapolation to 80,000 deaths).
9 Troyen Brennan et al., "Incidence of Adverse Events and Negligence in
Hospitalized Patients: Results of the Harvard Medical Practice Study," N Eng. J
Med 1991; 324: 370-6.
10 "Billions for Defense" at 2400. The second set
of reviewers found the same incidence of adverse events and adverse events due
to negligence, but not in the same charts. Rather than confirming the
reliability of the methodology used, this provides further demonstration of the
uncertainty of what is an adverse event and what is negligence.
11 "To
Err is Human" at 1, 22.
12 A Measure of Malpractice at 138.
13
"To Err is Human" at 42.
14 Id. at 4.
15 Id. at 47.
16
Id. at 37.
17 Id. at 85.
18 Id. at 94.
19 Id. at 105.
20 Id. at 9.
21 Id. at 103-104.
22 As the Report
recognizes, "One legal fear is that disclosure of internal quality data to
outside reviewers not under a peer review statute will lead to discovery from
JCAHO in lawsuits; indeed, many fear that disclosure to JCAHO would invalidate
even the nondiscoverability protections each hospital enjoys for its own data
under its state peer review statute." Id. at 108.
23 Id. at 96.
24 Id. at 9.
25 Id. at 8.
26 Unintentionally
demonstrating the problem, the Report also refers to the kinds of acts that
would fall under the voluntary (and confidential) reporting scheme as ones that
resulted in "no harm...(near misses) or very minimal patient harm." (p. 74) What
is supposed to be done with respect to injuries that fall between serious and
minimal?
27 "To Err is Human" at 5.
28 Id. at 76.
END
LOAD-DATE: February 15, 2000
