Context The Institute of Medicine has recommended establishing mandatory error
reporting systems for hospitals and other health settings.
Objective To examine the opinions and experiences of hospital leaders with state
reporting systems.
Design and Setting Survey of chief executive and chief operating officers (CEOs/COOs) from
randomly selected hospitals in 2 states with mandatory reporting and public
disclosure, 2 states with mandatory reporting without public disclosure, and
2 states without mandatory systems in 2002-2003.
Main Outcome Measures Perceptions of the effects of mandatory systems on error reporting,
likelihood of lawsuits, and overall patient safety; attitudes regarding release
of incident reports to the public; and likelihood of reporting incidents to
the state or to the affected patient based on hypothetical clinical vignettes
that varied the type and severity of patient injury.
Results Responses were received from 203 of 320 hospitals (response rate = 63%).
Most CEOs/COOs thought that a mandatory, nonconfidential system would discourage
reporting of patient safety incidents to their hospital’s own internal
reporting system (69%) and encourage lawsuits (79%) while having no effect
or a negative effect on patient safety (73%). More than 80% felt that the
names of both the hospital and the involved professionals should be kept confidential,
although respondents from states with mandatory public disclosure systems
were more willing than respondents from the other states to release the hospital
name (22% vs 4%-6%, P = .005). Based on
the vignettes, more than 90% of hospital leaders said their hospital would
report incidents involving serious injury to the state, but far fewer would
report moderate or minor injuries, even when the incident was of sufficient
consequence that they would tell the affected patient or family.
Conclusions Most hospital leaders expressed substantial concerns about the impact
of mandatory, nonconfidential reporting systems on hospital internal reporting,
lawsuits, and overall patient safety. While hospital leaders generally favor
disclosure of patient safety incidents to involved patients, fewer would disclose
incidents involving moderate or minor injury to state reporting systems.
Since the early 1990s, much has been learned about medical errors in
health care settings and of their impact on morbidity, mortality, and costs.1-6 The
1999 Institute of Medicine report entitled To Err Is Human documented the seriousness of the problem of medical errors and identified
the major challenges in addressing this problem.7 Although
a number of approaches to reduce errors were proposed, a key strategy involved
the use of reporting systems to identify and learn from errors.7
The Institute of Medicine recommended establishing both mandatory and
voluntary reporting systems for health care institutions such as hospitals
and nursing homes.7 The purpose of reporting
is to collect data on a broad range of events to detect systemic problems
that can be altered to reduce the risk of patient harm. Most mandatory systems
focus on serious injury to patients, but some also collect reports on incidents
such as drug diversions, patient elopement, or fires in the operating room,
which may not result in injury. In addressing the public’s “right
to know” about facilities’ performance, mandatory systems tend
to use state licensing authority to require that events are reported and hold
facilities accountable by ensuring that incidents are investigated and that
corrective actions are taken.8 Voluntary systems
are operated by governmental as well as nongovernmental organizations and
tend to emphasize quality improvement over public accountability. Other purposes
of mandatory and voluntary reporting systems, such as guiding consumers to
select safer facilities or providing a basis for health insurers and employers
to offer financial incentives to facilities with better safety records, are
as yet untested.
As of October 2003, 21 states had mandatory event reporting systems
for hospitals, although policies varied.9 Some
states mandate reports only for incidents causing serious harm, while others
include “near misses,” defined as errors that are caught before
they reach the patient, or if they reach the patient, do not result in injury
or harm. Some states release only aggregate data, whereas others release redacted
investigation reports. Eleven of the 21 states protect the confidentiality
of the reports, while 10 states allow for public disclosure including the
name of the facility. Of the 10 states, 7 release incident-specific data.9 Of these, some states keep confidential the names
of the practitioners involved, while others make this information available.
No state releases the names of patients.
Critics of mandatory systems worry they have a chilling effect on reporting.10 As a result, underreporting of events is suspected.9 Some observers note that reporting systems have the
potential to frighten the public unnecessarily if the data are not valid or
complete.9 In states that do not keep reports
confidential, there also are concerns about how to manage relations with the
press. It can be politically embarrassing if a family learns for the first
time of a serious reportable event involving a family member when it appears
in the media.
The goal of this study was to elicit the views of hospital executives
with regard to mandatory state reporting systems and closely related issues
of patient safety. We surveyed chief executive officers (CEOs) and chief operating
officers (COOs)—purportedly those officials most accountable to the
public and on the front lines of hospital reporting—in more than 200
hospitals in 6 states.
We selected a sample of acute care, nonfederal hospitals in Massachusetts,
Colorado, Pennsylvania, Florida, Georgia, and Texas and interviewed CEOs and
COOs. Where possible, we also sought information from chief medical officers
(CMOs). However, because the role of CMOs varies from institution to institution,
our primary analyses focus on the CEOs/COOs. The 6 states were selected because
they represented a spectrum of reporting systems, had wide geographic distribution,
and the hospital association for each state agreed to provide a letter of
support.
At the time of the study (2002-2003), Massachusetts had a mandatory,
nonconfidential reporting system. Facilities were required to submit reports
to the Department of Public Health for incidents involving “serious
physical injury (defined as “injury that is life-threatening, results
in death, or requires a patient to undergo significant additional diagnostic
or treatment measures”) resulting from accident or unknown cause”
and “other serious incidents that seriously affect the health and safety
of patients.”11 About 640 reports were
filed in 2001. Information collected through department of public health investigations
are provided on request (with the patient name redacted).
Colorado also had a mandatory, nonconfidential reporting system. Reports
were submitted to the Colorado Department of Public Health and Environment.
In Colorado, facilities reported specific “serious injuries” (eg,
brain or spinal cord injuries, life-threatening complications of anesthesia
or life-threatening transfusion errors or reactions, and certain burns). Colorado
would release a summary report of its investigation including the name of
the facility, but protected the identity of the health care professional involved
with the reported event.12
Pennsylvania and Florida both had mandatory, confidential reporting
systems. In Pennsylvania, hospitals were required to report to the Department
of Health “a situation or the occurrence of an event at the facility
which could seriously compromise quality assurance or patient safety.”
Pennsylvania law protected the confidentiality of information contained in
facility reports unless a court ordered the disclosure.13 In
Florida, hospitals reported adverse incidents to the Agency for Health Care
Administration. “Adverse incident” is defined in the statute as
“an event over which [a] health care professional could exercise control
and which is associated in whole or in part with medical intervention, rather
than the condition from which such intervention occurred,” and which
is associated with a list of injuries or actions.14 Georgia
and Texas did not have mandatory patient safety state reporting systems at
the time of our survey, although since then both have enacted one.
Lists of hospital leaders were obtained from the state hospital associations
and the American Hospital Association.15 All
hospitals in Massachusetts (n = 74) were selected, and 50 hospitals
in each of the other states were selected randomly.
We developed a draft questionnaire through focused interviews with experts
in the field of patient safety and with former hospital leaders, including
CEOs, COOs, CMOs, risk managers, and patient safety officers. The instrument
was cognitively tested in nonstudy states to improve the reliability of individual
items, and a modified version was pretested during fall 2002.
The final questionnaire elicited opinions about mandatory patient safety
reporting systems with public disclosure, defined as a policy whereby the
responsible state agency could release some details of the incident, including
the name of the hospital employees involved in the incident, to anyone making
a request. Our first area of inquiry addressed whether mandatory, nonconfidential
systems encouraged or discouraged reporting of patient safety incidents within
hospitals. We also sought opinions on the effect these systems had on the
likelihood of lawsuits being filed and on actual patient safety across the
state. Next, we asked what would most reduce hospital errors: a system that
releases the names of hospitals or practitioners involved, or one that keeps
names confidential.
A corollary issue to whether the state should release notice of patient
safety incidents to the public is whether, and under what circumstances, the
state should disclose details to the affected patients or their families.
At the time of the survey, hospitals were not required to tell affected patients
that a report had been filed, and states did not ask hospitals whether they
had provided the patient or family with information about the incident. Therefore,
we asked under what circumstances, if any, disclosure to patients is appropriate,
such as when information is about to be released to the press, or when the
patient or family already know about the incident and want to learn more details
from the state’s investigation.
For respondents in states with mandatory systems, we asked about the
clarity of the reporting criteria and how much discretion they had in deciding
what needs to be reported. Next, we presented each respondent (from all 6
states) with 3 vignettes of hypothetical errors involving serious harm to
patients that might occur during a hospital stay (Box). For example, one vignette was about a hospitalized
patient with a urinary tract infection who receives an antibiotic to which
he has a documented allergy. The patient has a severe reaction and lapses
into a coma. We asked respondents, “In your hospital, how often would
this kind of incident be reported to the ‘agency’ ”? and
“How often would someone from your hospital acknowledge to patients
or their family members that an incident of this kind occurred?” (always,
usually, sometimes, rarely, or never). We then varied the severity of the
resulting injury to the patient, repeating each of the vignettes a second
time with only moderate or minor harm occurring (eg, the patient with the
urinary tract infection had difficulty breathing and developed a pruritic
rash, but symptoms resolved after 2 hours), and a third time with very minor
or no harm (eg, no symptoms occurring.)
Box Section Ref IDBox. Three Vignettes of Hypothetical Errors Involving Harm to Patients
That Might Occur During a Hospital Stay
Vignette 1
A hospitalized patient is discovered to have a
urinary tract infection. A physician orders Bactrim [trimethoprim/sulfamethoxazole]
to treat the infection, not realizing that the patient has a previously documented
severe allergy to this drug. Suppose an hour after taking the Bactrim, the
patient complains of difficulty breathing and soon after is unable to speak.
Ten minutes later, he becomes unresponsive. An emergency resuscitation is
successful, but the patient remains in a coma for 5 days. When he regains
consciousness, he is unable to communicate, and this remains unchanged 1 year
later.
Suppose the outcome were somewhat less severe.
Suppose an hour after receiving the Bactrim the patient complains of difficulty
breathing and has an itchy rash. With treatment the symptoms resolve after
2 hours. The patient is monitored carefully, but has no further symptoms.
Now suppose the same situation occurred and the
outcome is even less dramatic. The day after the patient is given the Bactrim,
the documented allergy is noted and the Bactrim is stopped. The patient has
no symptoms.
Vignette 2
A patient has a vascular graft placed in the left
leg. The surgeon orders hourly postoperative checks of the pulse of the left
foot and asks to be called immediately if the pulse is undetectable. The nurses
on duty do not check the pulse for 4 hours. When a nurse does check, the pulse
is undetectable and the nurse calls the surgeon. Suppose the surgeon orders
a clot-dissolving medication, but it has no effect. The patient is taken back
to the operating room, but the graft cannot be revised. The left foot develops
gangrene and the patient has to undergo a below-the-knee amputation.
Now, let us suppose that the situation is less
severe. Suppose the surgeon orders a clot-dissolving medication, but it has
no effect. The patient is taken back to the operating room and undergoes revision
of the vascular graft. The patient recovers and is discharged 3 days later
than expected.
Suppose the patient is even less affected. The
surgeon orders a clot-dissolving medication and the pulse returns. The patient
does well and is discharged 3 days later.
Vignette 3
A patient comes to the emergency department with
a bleeding stomach ulcer and a low blood cell count. She undergoes endoscopy
and the bleeding appears to have stopped but she is admitted to the hospital
for observation so she can have her blood cell counts monitored every 6 hours
overnight. At midnight, the laboratory receives a specimen with an abnormally
low blood cell count, but the low blood cell count is never reported to the
patient ward and none of the nurses or staff check the result. In the morning,
the rounding physician finds the patient confused and lethargic with a rapid
pulse and low blood pressure. She notes the abnormal result from the night
before and orders a repeat endoscopy and an immediate blood transfusion. Before
the endoscopy, the patient’s heart stops. Resuscitation is unsuccessful
and the patient dies.
Suppose she ordered the same repeat endoscopy and
blood transfusion, but the outcome was less severe. Before the endoscopy,
the patient’s heart stops. There is a lengthy resuscitation, and the
patient’s bleeding is stopped. The patient remains in a coma in intensive
care for 2 weeks, but ultimately recovers.
Suppose she ordered the same repeat endoscopy and
blood transfusion, but the outcome was even less severe. The bleeding is stopped
and the patient recovers uneventfully.
To gauge the prominence of the issue, we asked about the frequency with
which the topic of patient safety was on the agenda at board meetings, and
the priorities placed on determining root causes of errors, identifying procedures
to improve patient safety, protecting reporters from negative consequences,
and finding out who was at fault. To understand the progress made by hospitals
in implementing the July 2001 Joint Commission on the Accreditation of Healthcare
Organizations standard (RI.1.2.2),16 we inquired
about written policies on disclosure of “unanticipated outcomes and
other patient safety incidents to patients and their families.” For
all analyses, hospitals were categorized by teaching status (major, minor,
nonteaching), ownership (nonprofit, for-profit, church-owned, government),
and bed size.
The survey was administered by the Center for Survey Research at the
University of Massachusetts, Boston, between November 2002 and March 2003.
We attempted to interview both the CEO and the COO. If both were interviewed,
we used the interview from the CEO (83% of respondents were CEOs, 17% were
COOs). We repeated the analyses using the responses by the CMOs and provide
those results separately. This study was approved by the institutional review
board at Massachusetts General Hospital. Names of participants and the hospitals
were known only to Center for Survey Research and Massachusetts General Hospital
study personnel.
Since we hypothesized that attitudes and behaviors would vary by type
of state reporting system, we grouped the states into 3 categories: mandatory,
nonconfidential; mandatory, confidential; and no mandatory systems. We used
the χ2 statistic to test for significant differences by type
of state and by hospital characteristics, but the latter produced few significant
results, so we do not present these tabulations nor did we estimate multivariate
models controlling for these variables. All responses were weighted by the
inverse of the probability of sampling multiplied by the inverse of the response
rate, within state category. P values and confidence
intervals were estimated using SUDAAN to account for complex survey designs.17 The level of significance was set at P <.05.
Response rates and characteristics of respondents’ hospitals are
presented in Table 1. The response rate
for CEOs/COOs was 63%. There were no differences by teaching status, but government-owned
and small hospitals were more likely to respond than religiously affiliated
hospitals and large hospitals. The response rate for CMOs was 41%.
Design of State Mandatory Reporting Systems
More than two thirds of hospital leaders thought that a mandatory, nonconfidential
reporting system run by the state would discourage reporting of patient safety
incidents to their hospital’s own internal reporting system (Table 2). Only 8% thought it would encourage
internal reporting, and there were no differences by type of state event reporting
system. Overall, about three quarters of hospital leaders (79%) thought that
such a system encouraged lawsuits against hospitals, although this number
was lower among respondents from the states having a mandatory, nonconfidential
system (P = .01). Most respondents (73%)
thought that a mandatory system would have either no effect or a negative
effect on actual patient safety within their own state.
Hospital leaders in our sample were strongly supportive of policies
that kept confidential the names of the hospitals and the practitioners involved
(Figure). Fewer than 3%, on average,
thought that releasing information on both parties was advisable. However,
respondents from states with mandatory, nonconfidential systems were far more
likely to approve releasing the name of the hospital (22%) than those from
other states (4%-6%) (P = .005).
Respondents from the 4 states with mandatory systems (n=146) provided
their opinions about circumstances under which state reporting systems should
inform the patient or family about a reported event. When an incident is reported,
half (51%) thought that the state should not release information to the patient
under any circumstances. About 16% thought the state should always inform
the patient, with the remainder (33%) saying that the patient should be informed
only under certain circumstances. Of the latter group, 91% thought that the
agency should tell the patient on imminent release to the press, 60% thought
the patient should be informed of the details of the case on request from
the patient or family, and 20% thought that the patient should be told when
there was harm involved. (Depending on the state system, not all reported
events result in harm to the patient, eg, fire in the operating room, equipment
failure, or patient elopement.)
Variation in Reporting Practices
Nearly a quarter (23%) of respondents from the mandatory reporting states
thought that reporting criteria were not very clear or not at all clear (results
not shown in Tables). When asked about the discretion their hospital had in
reporting incidents, 3% reported they had “a lot,” 46% reported
“a moderate amount,” and 46% reported “a little.”
Only 6% thought they had no discretion.
In response to the error vignettes, 89% to 98% of respondents from mandatory
reporting states would always or usually report a serious incident to the
agency, depending on the vignette, with no significant difference by state
(P>.05 for all vignettes) (Table 3). However, when the injury was less severe, respondents
from mandatory, nonconfidential states were less likely than others to say
they would report cases to the agency. For example, when the injury was moderate,
22% to 69% of respondents from nonconfidential states would always or usually
report the incident (depending on the vignette), compared with 43% to 89%
of respondents from confidential states (all P≤.01).
For the least severe scenarios, 3% to 7% from the nonconfidential states would
still report the incident, compared with 20% to 34% of respondents from confidential
states (all P≤.01).
A different pattern occurred for responses to questions on disclosing
incidents to affected patients or their families. Between 84% and 100% of
respondents (depending on vignette and state) said that someone from their
hospital would always or usually tell the patient about a serious event causing
harm, 75% to 96% would tell the patient about a moderate injury, and 38% to
57% would tell the patient about an incident involving minor injury or no
harm. Notably, with the exception of a modest difference in the responses
to the most serious injury level for vignette 3, these results did not differ
significantly by type of state.
Hospital Patient Safety Policies and Practices
Table 4 reports on hospital policies
and practices concerning patient safety. Because none of these practices varied
significantly by type of reporting system or hospital characteristics, we
report only overall percentages. A large majority of respondents (82%) reported
that patient safety was always or usually on the agenda at their board meetings.
A majority of respondents gave “very high” priority in their hospitals
to finding out the root causes of patient harm (83%), identifying procedures
to improve patient safety (62%), and protecting reporters from negative consequences
(60%). Far fewer (37%) put a very high priority on finding out who was at
fault for errors. Only 85% had a written policy that recommended disclosure
of unanticipated outcomes to patients. Of those, 87% recommended disclosure
for minor injuries due to errors, and 31% for errors that did not harm patients.
When we repeated the analyses using responses by CMOs, our conclusions
regarding the major hypotheses remained the same. Similar to CEOs/COOs, CMOs
expressed major reservations about mandatory, nonconfidential systems and
were wary about releasing names of individual practitioners involved in the
incidents. Chief medical officers were less likely than CEOs/COOs to say that
they would report moderate or minor injuries (based on the vignettes) to the
state or to disclose to the patient. However, the patterns of responses by
type of state system were similar to the CEOs/COOs, although fewer results
were statistically significant. Chief medical officers also tended to be a
bit less optimistic about patient safety priorities in their hospital, but
were still quite positive overall.
In the absence of federal legislation requiring hospitals to report
safety events, states find themselves increasingly involved in efforts to
monitor hospital safety practices. Despite potentially worthwhile aspects
of mandatory reporting, our results suggest that most hospital leaders had
serious reservations about these systems. On balance, hospital leaders believed
that mandatory, nonconfidential state reporting systems as designed discouraged
internal reporting of medical errors and led to a greater frequency of lawsuits
while failing to provide substantial benefit to patient safety.
One of the more contentious issues in a mandatory reporting system is
whether to keep the data confidential or to release identifiable information
on individual events to the public. Hospital leaders resoundingly favored
confidentiality. However, our data also suggest that, to a point, familiarity
breeds acceptance—respondents from mandatory reporting states with public
disclosure were less worried about lawsuits and more willing to have hospital
names made public. As time passes and hospital leaders reflect on their experiences,
acceptance of nonconfidential systems may increase.
All 4 states with mandatory reporting systems created regulatory standards
defining reportable events, yet many hospital leaders perceived a lack of
clarity. Furthermore, the results of our vignettes demonstrate considerable
state-to-state variation in what may be reported in practice, at least in
cases for which the injury was not severe. Notably, CMOs were less optimistic
than CEOs/COOs that reports would be filed or that patients would be informed,
although the patterns of responses by state reporting system were similar.
While it is tempting to attribute state variations to differences in confidentiality
protections, it is also possible that respondents were influenced by differences
in the language of the reporting standards. State systems should balance the
desire to customize their systems against the value of standardization,7 especially since nonstandardized language precludes
making comparisons across states or regions or over time.
Medical ethicists distinguish between the public’s right to know
about institutional performance (via mandatory public reporting) and the patient’s
right to know about errors in his/her own care (via disclosure from providers).18 Despite the existence of a Joint Commission on Accreditation
of Healthcare Organizations standard16 requiring
disclosure, only about three quarters of hospitals had written policies to
disclose minor error-related injuries. Responses to our vignettes revealed
that hospital leaders were more likely to disclose moderate or minor incidents
to their patients than to the state, particularly in states with confidential
reporting systems. While such practices are laudable, one implication is that
states may be missing events important enough to be disclosed to patients,
and therefore potentially of value to improving safety. In fact, some states
are expanding their reporting systems. Massachusetts, for example, recently
established the Betsy Lehman Center, an independent state agency, which has
as one of its first goals the establishment of a voluntary, confidential system
for collecting information on complications and near misses.
Attitudes also varied with respect to allowing state governments to
share details of mandatory reports with affected patients and their families.
About half of hospital executives thought that patients or families should
be informed, at least in certain circumstances. The remainder may have preferred
that their own hospitals assume this responsibility, but we did not ask about
that possibility. Regardless of respondents’ rationales, this represents
an important policy issue. To our knowledge, few (if any) state agencies routinely
inform the affected patient or family when an incident has been reported.
Instituting such a practice would help foster the goal of transparency, as
long as the information is released in carefully circumscribed situations.
As a way of avoiding uncertainty, perhaps states should require reporting
entities to indicate, at the time the report is filed, that they have disclosed
to the patient the fact that a report was submitted to the state and the details
that were included in the report.
Despite the national prominence of patient safety, only half the hospitals
always had patient safety formally on their board meeting agendas. On the
other hand, more respondents put a high priority on finding out about root
causes, improving procedures, and protecting reporters from negative consequences
than they did on finding out who was at fault. If this signals a trend away
from the blaming culture that has existed in the past, it may be indicative
of efforts to strike a more productive balance between professional accountability
and system performance.
Finally, this study suggests a number of potential strategies around
the uses of mandatory reports to guide quality improvement. For example, until
recently, most states have focused on case by case mitigation, rather than
on culling data to perform analyses of trends, systemic problems, and best
practices, followed by dissemination to the hospital community. The latter
approach represents an opportunity to increase understanding of common problems,
enhance the visibility of the issue, and begin to engage the interest of the
medical and executive staff. Second, states could encourage reporting by clarifying
definitions of reportable events and might consider developing special voluntary
collaborative projects with hospitals to collect confidential reports on a
small number of well-defined “near miss” events. Third, states
might grant hospitals protected access to a database of deidentified abstracts
of reported incidents. The information might alert hospitals to the potential
of similar events occurring in their facilities, allowing them to take proactive
steps to prevent their occurrence. Finally, states might consider reaching
out to state hospital associations and medical societies as a way of promoting
cooperative relationships between regulators and providers, and minimizing
duplication of reporting requirements.
Our study had several limitations that may affect its generalizability
or interpretation. Experiences in other states may differ from those in our
sample. Our response rate of 63% may lead to biased results if nonrespondents
had different views toward state reporting systems. Limiting the respondents
to CEOs and COOs may miss the views of other important actors such as safety
officers or risk managers. However, our analysis of the CMOs indicated that
on the fundamental questions regarding attitudes toward mandatory reporting,
there were not large differences of opinion. Furthermore, we focused on mandatory
systems, yet at least some states are experimenting with publicly run voluntary
reporting systems.
In conclusion, this study was performed because understanding the motives
and behaviors of key constituents is crucial to the success of public programs.19 Laws and regulations do not exist in a vacuum, and
their implementation often follows a bargaining process in which various actors
and organizations negotiate over the interpretation of objectives.20,21 Even where legal obligations exist,
affected parties may display discretion and autonomy, due to vague program
goals or nonstandard definitions. In the hospital setting, executive leaders
influence institutional policy and foster norms for their employees. These
individuals believe that existing state reporting standards fail in some cases
to provide clear guidance on what should be reported and that mandatory reporting
systems with public disclosure may actually discourage internal reporting,
lead to lawsuits, and impart little benefit to patient safety. Hospital leaders,
of course, have their own institutional biases, and there is some evidence
that hospitals that become accustomed to transparency may eventually grow
to be more accepting of it. However, if hospital leaders continue to harbor
negative views of reporting, it is unlikely that state mandatory reporting
systems will be highly successful in the long run.
Corresponding Author: Joel S. Weissman,
PhD, Institute for Health Policy, Massachusetts General Hospital, 50 Staniford
St, Ninth Floor, Boston, MA 02114 (jweissman@partners.org).
Author Contributions: Dr Weissman had full
access to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Weissman, Annas,
Epstein, Schneider, Clarridge, Kirle, Gatsonis, Feibelmann, Ridley.
Acquisition of data: Weissman, Clarridge, Gatsonis.
Analysis and interpretation of data: Weissman,
Schneider, Gatsonis, Feibelmann.
Drafting of the manuscript: Weissman, Annas,
Schneider, Feibelmann.
Critical revision of the manuscript for important
intellectual content: Weissman, Annas, Epstein, Schneider, Clarridge,
Kirle, Gatsonis, Feibelmann, Ridley.
Statistical analysis: Weissman, Gatsonis.
Obtained funding: Weissman, Schneider, Ridley.
Administrative, technical, or material support:
Weissman, Annas, Clarridge, Feibelmann.
Study supervision: Weissman, Epstein, Schneider,
Clarridge, Kirle, Ridley.
Financial Disclosures: None reported.
Funding/Support: This work was supported by
cooperative agreement 5 U18 HS11928 from the Agency for Healthcare Research
and Quality.
Role of the Sponsor: The Agency for Healthcare
Research and Quality did not participate in the design and conduct of the
study; in the management, analysis, and interpretation of the data; or in
the preparation, review, or approval of the manuscript.
Acknowledgment: We wish to acknowledge the
help and support of the state agencies and the 6 state hospital associations
that aided in identifying the study sample and writing letters urging their
participation. In particular, we wish to acknowledge the following: Ronald
Hollander, President, Massachusetts Hospital Association; Michael Boyson,
Director of Data Services and Research, Colorado Health and Hospital Association;
Sharon Haney, Program Manager, Hospital Complaints and Survey, Colorado Department
of Public Health & Environment Health Facilities Division; Larry Wall,
President, Colorado Health and Hospital Association; Karen Peterson, Chief
Operating Officer, Florida Hospital Association; Charlene Willoughby, (former)
Manager, Division of Medical Quality Assurance, Florida Department of Health;
Wayne Nesmith, President, Florida Hospital Association; John Combes, Senior
Medical Advisor, Hospital & Healthsystem Association of Pennsylvania;
Sandra Knoble, Director, Division of Acute and Ambulatory Care, Pennsylvania
Department of Health; Carolyn Scanlan, President and Chief Executive Officer,
Hospital & Healthsystem Association of Pennsylvania; Vi Naylor, Executive
Vice President, Georgia Hospital Association; Starr West, Director of Health
Care Quality, Texas Hospital Association; and John Evans, (former) Hospital
Licensing Board Director, Texas Department of Health. We also thank Jill Rosenthal
from the National Academy for State Health Policy, and Trish Riley, formerly
of the National Academy for State Health Policy, for aid in identifying state
systems and describing their attributes; Jack Fowler for advice on questionnaire
design; and Loraine Scampini for programming.
1.Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized
adults.
J Gen Intern Med. 1993;8:289-2948320571
Google ScholarCrossref 2.Bogner MS. Human Error in Medicine. Hillsdale, NJ: L. Erlbaum Associates; 1994
3.Brennan TA, Leape LL, Laird NM.
et al. Incidence of adverse events and negligence in hospitalized patients:
results of the Harvard Medical Practice Study I.
N Engl J Med. 1991;324:370-3761987460
Google ScholarCrossref 4.Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients: excess length of stay,
extra costs, and attributable mortality.
JAMA. 1997;277:301-3069002492
Google ScholarCrossref 5.Leape LL, Woods DD, Hatlie MJ, Kizer KW, Schroeder SA, Lundberg GD. Promoting patient safety by preventing medical error [editorial].
JAMA. 1998;280:1444-14479801008
Google ScholarCrossref 6.Rothschild JM, Federico FA, Gandhi TK, Kaushal R, Williams DH, Bates DW. Analysis of medication-related malpractice claims: causes, preventability,
and costs.
Arch Intern Med. 2002;162:2414-242012437399
Google ScholarCrossref 7.Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000
8.Flowers L, Riley T. State-Based Mandatory Reporting of Medical Errors:
An Analysis of the Legal and Policy Issues. Portland, Me: National Academy for State Health Policy; 2001
9.Marchev M, Rosenthal J, Booth M. How States Report Medical Errors to the Public: Issues
and Barriers. Portland, Me: National Academy for State Health Policy; 2003
10.Brennan TA. The Institute of Medicine report on medical errors—could it do
harm?
N Engl J Med. 2000;342:1123-112510760315
Google ScholarCrossref 11. Code of Massachusetts Regulations (CMR), Title 105, Chapter 130.331
(2003)
12. Colorado Revised Statutes 25-1-124 (2000)
13. 28 Pa Code §51.3(f) (2001)
14. Florida Statutes 395.0197(5)(a)-(d), §22, chapter 98-166 (1998)
15.American Hospital Association. AHA Guide 2001. Chicago, Ill: American Hospital Association; 2001
16.Joint Commission on Accreditation of Health Care Organizations. Patient Rights & Organization Ethics [R.I. 1.2.2]. In: Hospital Accreditation Standards. Oak
Brook, Ill: Joint Commission Resources Inc; 2003:79-80
17.Shah BV, Barnwell BG, Bieler GS. SUDAAN User's Manual. Release 7.0. Research Triangle Park, NC: Research Triangle Institute;
1996
18.Sharpe VA. Promoting patient safety: an ethical basis for policy deliberation.
Hastings Cent Rep. 2003;33:S3-S1814696279
Google Scholar 19.Cooksey JA, Krieg RM. Metropolitan health policy development: barriers to implementation.
J Public Health Policy. 1996;17:261-2748918019
Google ScholarCrossref 20.McLanahan SS. Organizational issues in U.S. health policy implementation: participation,
discretion, and accountability.
J Appl Behav Sci. 1980;16:354-36910297969
Google ScholarCrossref 21.Pressman J, Wildavsky A. Implementation. Berkeley: University of California Press; 1973