Copyright 2000 Federal News Service, Inc.
Federal News Service
February 9, 2000, Wednesday
SECTION: PREPARED TESTIMONY
LENGTH: 3244 words
HEADLINE:
PREPARED STATEMENT OF RANDALL R. BOVBJERG PRINCIPAL RESEARCH ASSOCIATE THE URBAN
INSTITUTE
BEFORE THE HOUSE COMMITTEE ON COMMERCE
SUBCOMMITTEE ON HEALTH AND ENVIRONMENT AND COMMITTEE ON VETERANS' AFFAIRS
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
BODY:
The Institute of Medicine's To Err Is Human is a strong reminder of
the extent of error in medicine and a promising conceptual blueprint for
improving patient outcomes. Its general patient-safety approach is to
de-emphasize blaming individuals for errors and injuries in the fashion of legal
liability or professional discipline. Those systems probably help, but do not
prevent the high level of avoidable error that many investigators have found.
Instead, errors can be reduced further by focusing on how systems within
which individuals operate can help support good clinical decision-making and
keep slips or lapses by caregivers from reaching patients and causing harm.
Shielded from blame, individual practitioners are meant to communicate freely
about problems, helping to find solutions through analysis of errors and
development of fail- safes and other safeguards. Methods emphasize the positive
of avoiding injury for patients and seek to actively support all practitioners
to do ever better rather than penalizing a few of them for being substandard.
This is a very exciting development for protecting patients. Implementing these
emerging approaches is a great challenge. One recommendation of the IOM panel
was to encourage learning about safety from cross-institutional reporting
systems for errors, which are now inhibited by fears that data will be
discovered in liability lawsuits. Federal legislation is proposed to protect the
voluntary reporting of ordinary injuries and "near misses" -- errors that did
not cause harm this time but easily could the next time. Not dissimilarly,
aviation near misses are confidentially reported and can be analyzed by anyone.
This seems a good idea, and for near-miss data, confidentiality would not deny
liability claimants any information now available.
Another
recommendation is to set national minimum standards for mandatory reporting to
states of serious injuries and deaths from error in hospitals. These reports
would not be confidential, unlike the typical existing state program. This
recommendation is understandable as a quest to balance the patient-safety
approach of confidentiality with the broader social demands for outside
accountability. Too much openness could drive information underground, however.
Current state reports seem to fall well short of estimated reportable problems.
Further investigation of how well existing systems work seems appropriate, not
immediate federal standards. In the meantime, progress can be made on the
substantial work of developing a coherent framework for uniform reporting.
Outside pressure needs to be maintained on medical providers to improve,
as complete voluntarism is unreliable. Without impacting the existing liability
system one way or the other, quality standards, more demanding buyers of care,
and regulators who emphasize patient safety principles could also help. Wherever
possible, pressures should be positive in tone, emphasizing processes for
improvement.
It's premature as yet to impose mandates and sanctions.
Better approaches will become feasible as more is learned about success.Thank
you for inviting me to testify today on "Medical Errors: Improving Quality Care
of Care and Consumer Information." My testimony addresses voluntary and
mandatory reporting of information about errors and associated confidentiality
issues.
The Emergence of Patient Safety. Researchers on injury and
liability issues have long recognized that medical injury and medical error
occur too often. If they were a disease, they would have their own Institute at
NIH. Moreover, injuries far exceed traditional efforts to fix them -- medical
peer review, regulatory discipline, or legal liability and risk management.
Fortunately, many injuries not prevented by current oversight systems
nonetheless seem preventable.
Better prevention requires a new mix of
information, motivation, and implementation. The big question now is what mix of
policy tools can best address prevention in various medical settings, for
various types of care and their characteristic problems. Observers and policy
makers differ in their conceptualization of problems and in the emphasis they
would put on different policy tools. I urge you today to consider that a
multiplicity of tools may be appropriate, each in their own way, but that we
proceed carefully and avoid working at cross purposes.
This heating
continues the lively debates sparked last November by the Institute of Medicine
(IOM) report To Err Is Human. This book has performed an extremely valuable
service. More successfully than any of the prior efforts on which it builds, the
IOM panel has highlighted existing knowledge on the extent of preventable
injury, mainly in hospital care. This alone has put patient safety higher on the
policy agenda than ever before. This is an extremely exciting and important
development.Better yet, the book describes emerging methods of preventing
medical errors from hurting patients and lays out a vision of patient safety as
an alternative approach to error. The book focuses more on systems design and
operation than on individuals. It emphasizes the manifold nature of errors and
how prevention calls for developing and implementing a variety of techniques to
identify problems and achieve solutions. It also seeks to de-emphasize
retrospective blame finding as a policy tool in favor of front-end safety
design, catching errors before they can reach patients, and building in
self-monitoring and continuous improvement for the future.
In short, the
IOM panel presents a very attractive vision of patient safety as a general
approach, with specific examples from a few clinical areas. Actually getting
clinicians and clinical managers to act in this fashion is a tall order. There
are many real-world examples of significant progress, but there is a long way to
go. Another tall order is balancing the social demand for external
accountability with the prescription to downplay blaming. In short, more is
known about problems than about what approaches to improvement works best. But
that's normal. The ability to diagnose problems always runs ahead of the ability
to prescribe cures.
Speaking personally, my own research for twenty
years addressed malpractice mainly as a matter of law and liability insurance. I
wrote about how those systems perform, and how actual and proposed reforms
affect that functioning. A particular interest has been no-fault alternatives,
which have the potential for efficiencies as well as for sending clearer signals
to practitioners about the extent and nature of medical injuries. It has long
troubled me that medical-legal research has always found significant levels of
preventable injury -- starting with the first systematic study of medical injury
and negligence in the early 1970s.My own first project specifically on injury
prevention began just two years ago. Since then, I've learned much more about
the practical issues of making changes in clinical and administrative systems to
protect patients. One very recent advance is that "patient safety" is now
readily understood to mean protecting patients from medical injury in many ways.
Only two years ago, even well informed clinicians and risk managers usually
thought of "safety" as having to do with hazard-free premises -well lighted
parking lots, non-slippery stairwells, clearly marked fire exits, and the like.
"Risk management" usually meant defending against lawsuits and coping with other
legal system demands on clinicians, like Medicare compliance issues. There was
little attempt to actively address any factor that might hurt patients.
All this seems to be changing as some medical leaders are learning more
about promoting safety, not just avoiding malpractice. Efforts are underway in
many institutions across the country, not just hospitals but also large
physician groups. This type of work is much more exciting in terms of direct
improvements for patients than lots of debates rye been in about law and
insurance or the pros and cons of tort reform.
Learning
from Reporting Systems across Institutions. This morning, the main topic is the
potential role for medical error reporting. Sharing information across sites
through reporting can help build the knowledge base for improvement. One must
start with information about how different types of medical errors occur and how
they reach patients in order to begin to prevent them. Medical providers have
important information -- what clinicians knew and did or didn't do, the
circumstances of a case, the environment in which it occurred. One key to
improvement is to be able to study occurrences, errors that led to injury or
might have done so. Much can be learned by self study and literature
review,especially in hospitals or large physician groups. Sometimes, however,
larger scale is needed. Hence the interest in reporting systems to compile
information on error in medicine.
Institutional care is the focus of
most existing reporting systems and the IOM proposal -- especially hospital
care. It's plausible that the need for more information is even greater for
non-institutional care, where individual and small groups of practitioners lack
the advantages of scale and scope of larger entities. Outpatient care is
generally believed to have less potential to hurt patients than more complex
hospital care for sicker patients. Still, "failure to diagnose" liability cases
are among the more expensive claims, and there are also many issues of follow up
and coordination of care among independent offices. Outpatient care, however,
remains a raw frontier for safety development.
For the IOM panel, I and
my colleague David Shapiro, an M.D., J.D. expert from California, examined some
aspects of reporting systems. We researched a number of leading voluntary
systems, concerns about their ability to maintain confidentiality, and what
existing and potential legal protections could enhance confidentiality. We
inevitably also learned about some mandatory programs, though with less detail.
Our conclusions are fairly presented in chapter six of the IOM book (pp.94-113):
Liability law gives broad scope to litigants to discover information relevant to
their claims, or even that might lead to relevant information. When
quality-oriented information is kept confidential within a health care entity
(mainly hospitals) and used for peer review purposes, it is typically not
discoverable. Risk management information for defense of claims also has some
protection from discovery.
These protections are seldom absolute,
however, and sharing data on problems outside the entity raises legal
vulnerabilities. Information need not be definitive to be useful. One attorney
noted that it is helpful just to know that a patient's hospital chart was
submitted to the peer review committee, despite the absence of information about
the confidential review or its findings. Just seeing the stamp "referred to peer
review" on the chart used to make it much easier to get an expert witness to
review the case. Hospitals learned of this effect and stopped using such stamps.
This illustrates a key observation about data on errors. People are very
reluctant to report on themselves or colleagues unless they have a reasonable
expectation of confidentiality. Whatever one's views about the appropriateness
of open confession of error, it is a practical reality that few medical
practitioners want to do it within what they perceive as a litigious or vengeful
environment. All our interviewees at reporting systems stressed the importance
of confidentiality in getting practitioners to report; fears of legal and other
repercussions are very strong. All said they thought reporting of errors falls
vastly short of the true extent of error.
It is difficult to get people
to discuss potential failures at all, much less report them to regulators
empowered to discipline them, especially if litigators may also get hold of
them. Hesitation is built into behavior even without disclosure. Note, for
example, that the first information a liability insurer or hospital risk manager
often gets that something may have gone badly wrong in patient care is an
inquiry or notice of suit from a patient's attorney. Reporting by the
practitioners involved has traditionally been very low -- even though they are
contractually obligated to report claims, even though they're reporting only to
the people whose job it is to defend them, and even though the reports are
internal and confidential.
Stronger confidentiality protections would
probably improve voluntary data sharing. That's why the IOM panel recommended
new federal legislation. If cross.state reporting is to expand greatly, this may
indeed be required. There are existing legislative models of confidentiality
protection on which to base new rules, including those applying to peer review
and to the National Practitioner Data Bank. The panel recommended a
decentralized approach, as different expertises and scales of operation are
appropriate for different types of problems -- drug errors, blood transfusions,
emergency medicine, and so on.
Many states have created mandates for
hospitals to report serious injuries to a state regulatory agency, often along
with other matters, including epidemics and fires. Typically, a case is
confidential unless the agency takes formal action against the institution.
Legal requirements and conditional confidentiality may plausibly increase
reporting overall, though this is undocumented. But it seems clear that even a
long-standing mandate, as in New York or California, elicits only a few thousand
reports of unnatural deaths or serious injuries a year (see Appendix D of the
IOM book, pp. 210-217). The rate of error and serious injury found by hospital
chart review in those states is far higher. Mandatory reporting may or may not
find more problems than does the liability or peer review system.
For
purposes of learning from reported mistakes, incomplete reporting may not be
critical. A clinical or administrative manager at hospital X can see that others
also have a lot of problem Y and hence decide to take action. An area for much
greater work is how to report or otherwise generalize knowledge about solutions
as well as problems.
Reporting systems cannot measure the true incidence
of particular problems, however, because they don't know either of the two key
factors: They cannot count how many errors truly occurred (say, in a state or in
a type of hospital). Nor do they know how many patient encounters it took to
generate the observed level of reported cases. For this reason, it's a bit
troubling that incomplete systems can be used to discipline medical providers.
Reporting Systems as Motivators of Change. This observation leads to a
second issue about safety -how to motivate change among doctors and hospitals.
Here, the IOM panel touched briefly on the importance of corporate leadership
(chapter eight, pp. 143-144) and appeals to professionals' desire to excel in
quality, now including attention to error prevention. These are good things.
However, considerable outside pressure seems needed as well. It's taken a long
time, after all, for most medical leaders to begin to accept that major
improvements seem possible, despite all the rhetoric about American medicine as
the best in the world. And complacency about performance continues; many
hospital executives seem to think they are doing enough about injuries already.
Enter state regulators as motivators. The threat of sanction after
investigation of a reported serious occurrence is surely meant to encourage
change. How well this works goes beyond the scope of the IOM book and is worthy
of much more attention. How well staffed and funded are the relevant agencies?
What are their capabilities to investigate, especially promptly and outside
their home offices? How much are individual cases studied as against patterns of
problems? Can regulators recognize when other factors than error affect
reporting (e.g., nurses' labor dispute with hospital)? What sanctions do
regulators use? How much acceptance is there of the appropriateness of their
findings among the regulated entities? Do the regulatees in fact change? How do
regulators try to generalize advice to the industry at large? The questions go
on and on.
Given the wide range of unanswered questions, the appropriate
federal action at this point seems to be to learn more about what states are
doing and accomplishing rather than to mandate federal minimum standards.
According to news reports, the Administration has decided to oppose mandatory,
open reporting at this stage. I agree with that position.Proponents of
traditional and expanded litigation normally assert that motivating preventive
efforts is their key contribution -- what lawyers call deterrence. This must be
at least partly true: The highly successful anesthesiology guidelines, even the
patient safety movement itself, was partly a reaction to liability pressures.
Formal research has found little evidence of deterrenee, however. Support for
the hypothesis that exposure to fault liability promotes safety comes from some
studies comparing no-fault with fault-based systems for auto accidents. Yet the
tie between lawsuits and motivation to promote safety seems weak. Hospitals and
other entities within a particular jurisdiction all face the same basic legal
rules, yet they differ greatly in their willingness to tackle patient safety as
a management priority. Moreover, to repeat: whatever the level of deterrence has
been accomplished by liability pressures, it hasn't done enough to protect
patients. And it tends to inhibit open sharing of data and methods for safety,
even internally.
One last comment here: Regulation and litigation are
not the only tools available to motivate change. It's appropriate for buyers of
health care to demand much more of providers. That is another major topic on its
own. It seems possible to start with some outcomes measures, such as rate of
late discovery of cancer, and more pressure for providers to adopt processes
thought to help reduce errors. Again, to the extent feasible, at this stage of
development it seems preferable to emphasize support for improved processes
rather penalties for poor outcomes. Hospital accreditation is doing some of that
already, but buyer pressure offers another useful approach, one barely touched
upon in the policy debate thus far.
Implementing Change. Changing
clinical and administrative processes to protect patients calls for good
management, beyond good information and motivation to act. It is one thing for
leaders or outside experts to proclaim devotion to patient safety and discuss
methods in general terms, quite another to make changes in everyday practice. It
is notoriously difficult to manage health care providers, and the appropriate
system to manage is not clear, especially outside of hospital-based and large
physician group practice. Very few private entities have anything like the
corporate organization of Veterans Affairs, where top leadership has begun
substantial change. Management issues merit much more attention.
Readers
will note that this testimony has become sketchier as it proceeds from theory to
actual implementation of change. There is a reason for that. Theory is running
ahead of practice. Much remains to be learned, but the promise is bright.
END
LOAD-DATE: February 10, 2000
