Special Section -- Patient Safety
Institute Receives Grant to Study Pharmacogenomics and Minority Populations
The National Institutes of Health has awarded a grant for $895,000 to the Health Law & Policy Institute to research Pharmacogenomics and Minority Populations. Pharmacogenomics describes scientific efforts to understand the effects of genes on differences in drug response and to develop drugs that take advantage of such human genetic variations. The National Institute of General Medical Sciences will administer the grant together with the National Institute of Environmental Health Sciences and the National Human Genome Research Institute.
The two-year grant will examine the ethical, legal, and social implications of the use of pharmacogenomic information with particular attention to issues of race and ethnicity. With contributions from the University of Texas – Houston Health Science Center, Telesurveys Research Associates, and leaders in genome science, clinical genetics, bioethics, medical anthropology, minority health, the pharmaceutical industry, and the pharmacy profession, the Institute will conduct a survey of public opinion to determine how various racial and ethnic groups view pharmacogenomics and its role in drug trials and diagnostic testing; host a conference that brings scholars, industry representatives, and other policymakers to discuss the results; and publish a book and several papers on pharmacogenomics and the results of the research.
Thornburgh's Gardere Wynne Sewell and Riggs Lecture Addressed ADA
On
February 24, 2000, Governor Dick Thornburgh, former Pennsylvania Governor
and Attorney General for the Bush and Reagan Administrations, presented
"The Americans with Disabilities Act: A Retrospective" as the Gardere Wynne
Sewell & Riggs Lecture. Governor Thornburgh was U.S. Attorney General
when the ADA was signed into law ten years ago.
He discussed the progress made since the ADA's passage and assessed the work that remains ahead for Americans to have a society in which individuals with disabilities lead fuller, more productive lives. Governor Thornburgh's remarks are available on the Health Law & Policy Institute's Web site at http://www.law.uh.edu/healthlaw/thornburgh.html.
The
lecture was underwritten by the law firm of Gardere Wynne Sewell &
Riggs L.L.P. A panel discussed the policy implications of Governor Thornburgh’s
remarks. The panel included: Andrew Imperato, President and CEO, American
Association of People with Disabilities, Becky Ogle, Executive Director,
Presidential Task Force on Employment; and Patrisha Wright, Director, Governmental
Affairs, Disability Rights Education and Defense Fund.
At
the luncheon sponsored by TIRR and Continental Airlines that followed the
panel discussion, Gordon Bethune, Chief Executive Officer of Continental
Airlines, spoke, and former President George Bush presented the Bush Medals
of Honor for contributions to the advancement of individuals with disabilities.
The recipients were: Elizabeth Boggs, Founder of the Arc (formerly the
Association for Retired Citizens); Justin Dart, Disability Rights Advocate,
and Founder of Justice for All; Evan Kemp, former Chairperson of the U.S.
Equal Employment Opportunity Commission; Joshua Malinga, President of Disabled
Peoples International; Dick Thornburgh; and Patrisha Wright, Director,
Governmental Affairs, Disability Rights Education and Defense Fund.
Photo immediately
above: Arthur K. Smith, Dick Thornburgh,
Patrisha Wright, President
George Bush, Laura F. Rothstein,
Mark A. Rothstein, Yoshiko
Dart (for Justin Dart), Janine
Bertram-Kemp (for Evan
Kemp), Joshua Malinga,
Brenda Doss (for Elizabeth
Boggs)
Top photo:
Dick Thornburgh
Photo above right:
Gordon Bethune and Laura Rothstein
Nominations Sought for 1st Annual Texas Employer Innovation in Healthcare Award
The Health Law & Policy Institute at the University of Houston announces its first annual award to Texas employers that have implemented innovative solutions to provide better healthcare to employees. The Institute is recognized as one of the top health law programs in the country.
Employers must be Texas-based or have a significant Texas presence. Public, private, and not-for-profit employers are eligible. Three awards will be given, based on the employer’s size:
For further information or to submit a nomination, contact :
Ronald L. Scott
Health Law & Policy Institute
University of Houston
Houston, TX 77204-6381
Nominations may also be submitted via e-mail to rscott@central.uh.edu. Nominations must be received by May 1, 2000. Winners will be announced by June 1, 2000. A profile of winners will be published in Health Law News.
Free E-Mail Service Available from Institute Web Site
The newest feature added to the Health Law & Policy Institute Web site enables users to sign up for free e-mail updates from the Institute. The updates will inform users of new postings on the Institute Web site, including, for example, Health Law Perspectives articles, which analyze recent developments in health law and are posted on the Internet several times a month. Subscribers will also be alerted to other useful publications, new Web site features, and upcoming special events of the Institute.
Health Law Students Participate in Eighth Annual Health Care Team Competition
The Eighth Annual UT-Houston Health Care Team Competition will be held on Tuesday, March 28, 2000, from 5:30 – 7:30 p.m. in the third floor lecture hall of the UT-Houston Medical School, Room 3.00. Seven students from the University of Houston Law Center will be participating this year: Jeff Jones, Tam Le, Amber Orr, Ellie Paukert, Swapna Reddy, Judy Ringholz, and Farrah Woloshin. Other disciplines represented include social work, pharmacy, medicine, nursing, dentistry, public health, and the biosciences. The purpose of the competition is to challenge the ability of students in different disciplines to evaluate and respond to complex problems and encourage an interdisciplinary team approach to health care. On the night of the competition, three teams are presented with a hypothetical case. Before an audience, they must elicit as much information as they can from "experts" on stage and arrive at a plan. Mary R. Anderlik is the Law Center’s representative on the Faculty Planning Committee, which developed this year’s case and will select the winner of the Competition. The Competition and a reception immediately following the event are free and open to the public.
Health Law Organization Hosted Speaker and Held Fundraiser
On
February 1, 2000, Professor William J. Winslade spoke to the Health Law
Organization (HLO) about traumatic brain injury. He also discussed the
Health Law & Policy Institute's J.D./Ph.D. program. Professor Winslade
is Distinguished Visiting Professor of Law and Associate Director for Graduate
Programs of the Health Law & Policy Institute. His book, Confronting
Traumatic Brain Injury: Devastation, Hope and Healing, recently came
out in paperback. On February 14, 2000, the HLO held a bake sale. Proceeds
benefited the MLK Center.
Focus on Adjunct Professors
Marcus Stevenson and
Annette Zinn
Marcus Stevenson and Annette Zinn are new adjunct professors at the University of Houston Law Center. Their backgrounds make them uniquely qualified to teach Food and Drug Law. They are teaching the course together for the first time during the spring semester of 2000.
Stevenson
is an attorney with Kruse, Luccia & Evans. He represents manufacturers
of products regulated by the Food and Drug Administration (FDA) in product
approval applications and litigation initiated by the United States. He
also defends physicians, hospitals, and other health care providers in
medical negligence and wrongful death suits. From August 1995 to August
1997, Stevenson worked in the Office of the Chief Counsel of the FDA as
Assistant Chief Counsel for Enforcement. Stevenson received his LL.M. in
Health Law from the University of Houston Law Center in 1998, his J.D.
from Boston College Law School in 1995, and his B.B.A. from Texas A&M
University in 1992.
Annette
Zinn is employed at Cyberonics, Inc., where she is responsible for preparation
of Premarket Approval Applications to the FDA and similar agencies in other
countries, and IDE clinical applications and handles legal matters related
to clinical and regulatory affairs. She has provided legal and consulting
services to medical device manufacturers worldwide concerning strategic
planning, product registrations, distributor contacts, quality system registrations,
and FDA export clearances for medical devices. Zinn received her Ph.D.
from the University of Texas School of Public Health in 1995, her J.D.
from South Texas College of Law in 1992, her M.P.H. from the University
of Texas in 1981, and her B.S. from the University of Houston in 1978.
Book Review
Undue
Risk: Secret State Experiments on Humans
By Jonathan D. Moreno
W.H. Freeman & Co.,
New York, N.Y., 2000
$24.95
Reviewed by Seth J. Chandler
Associate Professor of Law
University of Houston Law
Center
War fosters utilitarianism. Participants believe that if they do not at least transiently seek the greatest good for the greatest number -- or at least the greatest number of some favored class -- they will be permanently destroyed by those who engage in that calculation without sentimentality over individual rights. It is on this Darwinian basis that many nations routinely command soldiers to assume a heightened risk of death.
The utilitarian approach rests in tension, however, with the ideology of modern medicine functioning in a modern world. Modern medicine is generally supposed to elevate individual rights and individual freedom above collective welfare. We generally insist on "informed consent" before experimenting on people, even where those experiments might vastly benefit society and where the need to gain consent retards progress or increases cost. We treat people differently than lab animals, whose individual welfare is generally thoroughly subordinated to the collective interests of the human species. Weapons of mass destruction mean, however, we are always, in some ways, in a state of war. The resulting collision between the utilitarianism suggested by modern warfare and the ethos of rights and freedom that supposedly underpin our democratic society forms the subject of Jonathan D. Moreno's book, Undue Risk: Secret State Experiments on Humans.
The strength of the book lies in the research marshaled by Moreno, an academic of distinction and senior staffer of a presidential advisory committee on American human radiation experiments. The book goes beyond American atomic testing, however, and chronicles across nations and across the twentieth century, the ways in which many governments, most prominently those of Nazi Germany, imperial Japan, and cold war America persistently subordinated individual interests to those of a favored class. From the bone removal experiments of Nazi Germany, to imperial Japan's extensive testing of biological weapons on prisoners, to cold war America's field testing (e.g. New York subways) of biological warfare materials, Moreno 300-page account discovers just how frequently the perceived demands of war prevail. And he shows how some current American military research attempts with some success to use solider altruism (fortified by extra pay) to reconcile the tension between the demands of modern warfare and an ethos the military has intermittently internalized of respect for individual rights.
The book's struggle to use the Nuremburg trials of Nazi war criminals as a lens with which to examine subsequent cold war behavior is provocative and commendable. As Moreno notes, except for the perhaps not insignificant fact that America did not deliberately kill the human guinea pigs that managed to survive the experiments, the theories on which some of the Nuremberg participants were sent to their deaths might criticize American doctors who, for example, relied on rewarding prisoners as a vehicle for obtaining "volunteers" for plutonium injections. Likewise fascinating is Moreno's account of the struggle within the Pentagon to internalize the "Nuremburg Code" of experimental ethics (http://www.ncgr.org/gpi/odyssey/privacy/NurCode.html) that had coalesced under the catalyst of the war crime prosecutions.
The book is considerably less satisfying, however, on one account. It is not a page turner, not even in the New Yorker sense. The pedestrian writing and sometimes diffuse focus disappoints, particularly given the terrific research it fails to enliven and the expectations one has of Moreno, who is an accomplished author with experience as a public commentator. Still, as a broader account of modern human experimentation than that provided by the presidential advisory committee on which Moreno served (http://www.ohre.doe.gov/ohre/index.html), Undue Risk adds significantly to the literature of informed consent.
Second, however, is a failure
to grapple with either the alternatives to our historic lapses in attention
to individual rights or to the psychology of the participants in that process.
Without an understanding of those alternatives -- such as increasing the
risk of a loss in the cold war -- or that psychology -- I care for mankind
enough to hurt you, there is an undue risk that the abuses documented by
Moreno will recur. This latter failing, however, simply leaves the door
open for further research -- an activity that will be well aided by Moreno's
compendium of situations in which war or fear of war led to medicine taking
what many might agree was undue risk.
http://tis.eh.doe.gov/ohre/roadmap/achre/summary.html
PUBLICATIONS:
Laura F. Rothstein
DISABILITIES AND THE LAW - Fall 1999 Cumulative Supplement (Westgroup)
SPECIAL EDUCATION LAW (Longman/Addison Wesley 3d ed. 2000)
Chapter on School Choice and Students with Disabilities in SCHOOL CHOICE (Stephen Sugarman & Frank Kemerer eds.) (Brookings Institute 1999)
Mark A. Rothstein
Occupational Safety and Health Law, 4th ed. (West Group) (2000 Supplement)
Genetic Testing in Adoption: Joint Statement of the American Society of Human Genetics and the American College of Medical Genetics, 66 Am. J. Human Genetics ___ (2000) (with Mary Kay Pelias)
Presentations
Laura F. Rothstein
"Health Care Professionals with Disabilities," Baylor College of Medicine, Houston, Texas, January 14, 2000
Mark A. Rothstein
"Trends in LL.M. Programs," Section on Graduate Legal Education, Association of American Law Schools, Washington, DC, January 7, 2000
"The Gentecization of Medicine: Some Ethical, Legal, and Social Implications," Methodist Hospital Grand Rounds, Houston, Texas, January 12, 2000
"Genetic Discrimination in Employment and Insurance," University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania, January 26, 2000
"Ethical Issues in Genetic Testing and Counseling," Bioethics Grand Rounds, University of Pittsburgh Center for Bioethics and Health Law, Pittsburgh, Pennsylvania, January 27, 2000
"Ethical and Legal Implications of Behavioral Genetics," University of Missouri School of Law, Columbia, Missouri, February 3, 2000
"Star Trek, the Dead Sea Scrolls, and Other Links to Jewish Genes," University of Missouri Hillel, Columbia, Missouri, February 3, 2000
"Family and Community in Genetic Research," University of Texas School of Public Health, Houston, Texas, February 10, 2000
"Genetic Information in the Workplace: Some Second Generation Issues," Reforming States Group/Milbank Memorial Fund, Austin, Texas, February 14, 2000
"Why Is It So Difficult to Protect Genetic Information?," Bioethics Forum, Princeton University, Princeton, New Jersey, February 25, 2000
"Ethical, Legal, and Social Issues in Occupational Genetics Research," National Institute for Occupational Safety and Health, Morgantown, West Virginia, March 1, 2000
"Genetics and Internal Medicine," Texas Club of Internists, Houston, Texas, March 3, 2000
"Equality, Justice, and Freedom in the Genetic Age," Anti-Defamation League, Houston, Texas, March 9, 2000
"Legal Developments in Genetic Privacy," Dallas Bar Health Law Section, Dallas, Texas, March 15, 2000
"Government Regulation of Medical Records," Dallas 40, Dallas, Texas, March 15, 2000
"Genetics and the Work Force of the Next Hundred Years," Columbia University School of Law, New York, N.Y., March 28, 2000
William J. Winslade
"The Practice of Bioethics: Making a Difference in a Clinical Setting," Grand Rounds, Huntington Memorial Hospital, Pasadena, California, January 14, 2000
"Physician-Assisted Suicide: Personal Choices, Cultural Values and Legal Regulation," Medical Assisted Death Conference, Lisbon, Portugal, February 25-26, 2000
Appointments
Mary Anderlik
(Community) Member, Institutional Ethics Committee, Memorial Hermann Hospital
(Community) Member, Data Monitoring Committee, University of Texas M.D. Anderson Cancer Center
Elected Vice Chair of the
Board of Directors of Good Neighbor Healthcare Center
| "Health Care and the Greying of Small Town Texas" by Glen Provost, which originally appeared in the June 1999 issue of Health Law News, was reprinted in the December 1999 Texas Rural Health Reporter, the expanded quarterly newsletter of the Center for Rural Health Initiatives. Provost is Vice President for Health Policy and Planning at the Texas Tech University Health Sciences Center and a member of the Health Law & Policy Institute's Advisory Board. |
Focus on Our Graduates
Melissa K. Cantrell (J.D. '00) authored "International Response to Dolly: Will Scientific Freedom get Sheared?," 13 J.L. & Health 69 (1998-1999).
Sharona Hoffman (LL.M. '99) wrote an article entitled "A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments," which was published at 78 Ore. L. Rev. 203 (1999). She teaches at the Case Western Reserve School of Law.
Jason M. Medley (J.D. '99) is an attorney with Calvin, Richardson & Verner in Houston, Texas.
Elaine Roberts (J.D. '90) is an attorney with Bruckner & Sykes, L.L.P. She handles disability issues under federal and state statutes, including all titles of the Americans with Disabilities Act.
Kristi Schrode ('95) works for Bennett, Turner, & Coleman, a Washington, D.C. law firm, advising clients on legislative and regulatory issues, including medical privacy, research ethics, pharmacogenomics and genetic privacy, and human subjects research.
Julie Silverstein ( LL.M. ''98) is a health care attorney for the Legislative Council of the Vermont General Assembly.
Frederick R. Parker, Jr. (LL.M. '98) teaches Corporate Taxation, Business Aspects of Health Law, and Bioethics in the graduate College of Business at Louisiana State University in Shreveport. He is also an adjunct member of the faculty at LSU Medical School, where he teaches bioethics. He is practicing law on a limited basis. He published three articles last year: Washington v. Glucksberg and Vacco v. Quill: An Analysis of the Amicus Curiae Briefs and the Supreme Court's Majority and Concurring Opinions, 43 St. Louis L.J. 469 (1999); The Withholding or Withdrawal of Lifesustaining Medical Treatment under Louisiana Law, 45 Loy. L. Rev. 121 (1999); and Informed Consent and the Refusal of Medical Treatment in the Correctional Setting, 27 J.L. Med. & Ethics 240 (1999).
Houston Law Review Symposium Issue on Public Health Law
Emerging Issues in Public
Health Law
Gardere Wynne Sewell &
Riggs, L.L.P. Health Law Lecture
Address
Regulation of Tobacco: Health
Promotion and Cancer Prevention
David A. Kessler
Articles
Patient Safety, Risk Reduction,
and the Law
Larry I. Palmer
Tobacco, HIV, and the Courtroom:
The Role of Affirmative Litigation in the Formation of Public Health Policy
Wendy E. Parmet
New Courtroom Strategies
Regarding Firearms: Tort Litigation Against Firearm Manufacturers and Constitutional
Challenges to Gun Laws
Jon S. Vernick and Stephen
P. Teret
Essay
Law as a Structural Factor
in the Spread of Communicable Disease
Scott Burris
Comments
AIDS as a Weapon: Criminal
Prosecution of HIV Exposure
Amy L. McGuire
The Texas Communicable Disease
Prevention and Control Act: Are We Offering Enough Protection to Those
Who Need It Most?
Efrén A. Acosta
Note
Fore! The Americans with
Disabilities Act Tees off at Professional Sports in Martin v. PGA Tour,
Inc.,but Will It Make the Cut?
Kenneth E. Neikirk
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Introduction to Patient Safety
Mary R. Anderlik
Research Professor
Health Law & Policy Institute
University of Houston Law
Center
In
November of 1999, the Institute of Medicine (IOM) released a study entitled
To
Err Is Human: Building a Safer Health System. On February 22, 2000,
President Clinton announced a plan to implement many of its recommendations.
The president is supporting the mandatory reporting of serious errors at
the state level and a federal regulation requiring hospitals participating
in Medicare to adopt error reduction programs. In this issue of Health
Law News, we present a range of perspectives on the IOM report and
the handling of medical mishaps. This introduction provides the reader
with an overview and highlights some areas of controversy among our contributors.
Is safety a problem in health care?
Much of the data concerning medical errors in To Err Is Human is not new. Still, the IOM study has brought estimates of 44,000 to 98,000 deaths per year due to medical errors to the attention of a much wider audience. (An error is a failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. The importance of the concept of error lies in the possibility of prevention through attention to root causes.) Even using the lower estimate, more people die from medical errors than from highway accidents. Without some fundamental changes, the number of deaths attributable to health care itself, rather than an underlying condition, is likely to climb. Factors include:
Traditional approaches to patient safety include credentialing of health care professionals, morbidity and mortality conferences, peer review when incidents occur and are reported, tort liability, and criminal liability. The focus is generally on injuries, meaning little attention is paid to near misses. At the center of attention are events of professional negligence, i.e., incidents of sub-standard or below average performance by a professional resulting in patient injury. A system intended to compensate for negligent injury may be a poor proxy for periodic competency testing for health care professionals or a structure of sanctions and rewards linked to the development and dissemination of best practices by organizations. The threat of liability for negligence may promote mediocrity rather than innovation to improve safety.
The patient safety movement – ending the culture of blame
Those in the patient safety movement regard fear of punishment as a major impediment to reporting of adverse events, errors, and near misses, and therefore to the establishment of an adequate knowledge base for efforts at improvement. They believe that a "culture of blame" must be replaced by a "culture of safety" that focuses on flaws in systems. Alan Horowitz, a lawyer formerly with the Institute for Safe Medication Practices and now in private practice, develops this theme. Charles Mowll of the Joint Commission on Accreditation of Healthcare Organizations is concerned with the details of implementation: what changes are necessary to create a culture of safety? Connie Wallace looks at patient safety from the perspective of the risk manager, sensitive to the conflicts experienced by health care professionals and the dynamics of the hospital environment.
Concerns about the erosion of responsibility and accountability
Many argue that in order to eliminate fear as a barrier to reporting, stronger confidentiality protections, and evidentiary privileges that keep internal discussions, investigations, and reports out of litigation, will be required. However, such measures create concerns about accountability. Those within the patient safety movement link the safety of air travel to the existence of a nonpunitive, confidential reporting system, but the analogy between the airline and health care industries is imperfect. Fear of punishment may function as a disincentive to reporting in both contexts, but flights crews have one strong incentive for reporting that health care professionals lack (or face in very attenuated form), namely, the knowledge that their lives are on the line. Beyond this, from the perspective of the plaintiffs’ lawyer, justice is defeated when relevant information is shielded from discovery. Richard Mithoff and Janie Jordan take issue with a provision of the Texas Medical Practice Act that may have the effect of insulating hospitals from liability for failing to implement adequate systems for credentialing and peer review.
Barry Furrow notes that health care providers have an ethical responsibility to let patients and their families know when something goes wrong. Some have objected to the title of the IOM report because it implies "to forgive divine," thereby suggesting that health care professionals who err stand in need of forgiveness. However, taking responsibility for errors and expressing regret to those affected is not equivalent to accepting blame or perpetuating an impossible standard of infallibility for health care professionals. Professor Furrow also reviews some alternative approaches to compensation for injury.
Next steps
Investments in technologies that compensate for human limitations are already generating substantial safety benefits and cost savings. The Veterans Administration has implemented an electronic medical records system and bar-coding to prevent drug-dispensing and blood transfusion errors. LDS Hospital in Salt Lake City has demonstrated that drug-related errors can be cut substantially through computer systems that automatically screen for allergies and drug-to-drug interactions. Significantly, reductions in costs due to error prevention offset the investment required to develop and implement such systems within a few years.
In many discussions of safety, patients and family members have figured only as passive victims. This may be changing. Mediation is one mechanism for transforming family members into collaborators in the search to find out what went wrong and ensure that it does not happen again. In Massachusetts and many other states, disclosures in the context of mediation cannot be used later in litigation, hence mediation creates a "safe harbor" for open communication. Efforts are also underway to enlist patients as partners. First generation projects include the design of educational pamphlets for distribution to patients. Next generation projects will use the Internet and other interactive technologies. For example, the Health Commons Institute is launching a demonstration known as "SeniorMed." Patients will be able to access their medication records online and communicate with clinicians via email. Clinicians will be able to check their patients’ actual medication use against prescribed medications and provide timely feedback to patients and colleagues using the same medium.
These efforts to involve patients and family members may have the side-benefit of promoting public understanding of health safety issues. In a Kaiser Family Foundation/Harvard Health News Index survey conducted at the end of 1999, fifty-one percent (51%) of respondents said they closely followed the IOM report—an impressive level of interest. However, thirty-two percent (32%) of respondents thought the report recommended tougher malpractice laws, and twenty-nine percent (29%) thought the report called for more severe punishments of doctors and nurses who make errors. Americans are getting the message that safety is a problem in health care, but many do not understand the nature of the problem or realize they can be part of the solution.
Conference on Patient Safety
The Health Law & Policy Institute is collaborating with other organizations in Houston and Texas to promote patient safety through the Texas Forum on Health Safety. The Forum will be sponsoring a conference in Houston on June 16, 2000 entitled "Texas Forum 2000: A Culture of Safety in Action." Confirmed speakers include James P. Bagian, Director of the National Center for Patient Safety at the Department of Veterans Affairs’ Veterans Health Administration, Henri Manasse, Jr., Chair of the National Patient Safety Foundation Board of Directors and Chief Executive Officer of the American Society of Health System Pharmacists, and Michael R. Cohen, President of the Institute for Safe Medication Practices. For more information, call Cathy LaComb at (713) 704-6144.
The Problem of Medical Error: The Institution as Toxin
Barry R. Furrow
Director of the Health Law
Institute
Widener University School
of Law
Medicine
is too often practiced on the principle that "it can't hurt." Medical treatment
unfortunately often does hurt patients. Iatrogenic effects in patients
can result from physician error, hospital-based infections, complications
of surgery, drug side effects, or "cascade effects" that occur when several
successive interventions go wrong. Medical accidents occur surprisingly
often. Patients suffer high levels of iatrogenic injury, particularly in
hospitals. The most severe injuries are often caused by medical errors,
a reality often ignored by hospital managers who otherwise are enthusiastically
adopting corporate management tools. Autopsy studies have found rates as
high as 40% of missed diagnoses causing patient deaths. A study of intensive
care patients found an average of 1.7 errors per day per patient, 29% having
the potential for serious or fatal injury. A Harvard Study found that the
incidence of adverse events suffered by hospitalized patients was 3.7%,
with 28% of these due to negligence. About 1% of all hospitalized patients
suffered a negligent medical injury. Extrapolating this finding to the
entire United States, over 10,000 iatrogenic deaths and as many as one
million injuries due to error occur every year. More than half may be due
to negligence.
The irony of this cascade of new information about medical errors is how invisible these errors have been, scattered among hundreds of hospitals and other institutions, underreported and often unnoticed. Airplane crashes are highly visible and have led to a highly sophisticated accident response as a result. Medical errors by contrast are detected only through malpractice suits for severe injuries and committee scrutiny within hospitals. Starting with the Harvard Medical Practice Study and Lucian Leape's work, however, scrutiny of health care errors has intensified. The most important work to date addressing medical error is the Institute of Medicine report, To Err Is Human: Building a Safer Health System. (Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, eds. 1999) (Report).The Report offers a critical look at the shortcomings of the health care system in handling error. It makes strong statements: human beings in the health care system make mistakes, lots of them; the current system thwarts rather than encourages detection and reduction of these mistakes; but systems can be designed to reduce these errors. The Report is ground-breaking in its emphatic recognition, finally, that health care is a complex technological system prone to error. By forcing us to change perspective -- from an obsessive focus on the acts of individual providers who make mistakes to the role of an institution in managing and reducing such mistakes -- the Report reorients the industry toward management of risk and error.
Medicine has not made accident-prevention a primary goal. Physicians strongly desire to be infallible, thus creating pressure toward intellectual dishonesty and the coverup of mistakes. Legal strategies addressing poor quality medical practice have traditionally focused on deviant behavior and substandard performance when analyzing the individual physician. These analyses result from the historical dominance of medical practice by the sole practitioner or the autonomous member of the hospital medical staff. The organization of medical practice, particularly in hospitals, exacerbates these tendencies. The threat of a malpractice suit also pushes errors underground. As Lucian Leape has observed, "[e]ven a minor error can place the physician's entire career in jeopardy if it results in a serious bad outcome." Systems and individuals cause errors. The Report calls for "a comprehensive approach to improving patient safety," noting that "[m]ost errors and safety issues go undetected and unreported both externally and within health care organizations." With the exception of anesthesia, where a recognition that systems factors cause errors has led to a fail-safe system and better training to reduce such errors, health care has yet to implement any larger mechanism to detect such errors based on system deficiencies and individual errors. The Report is an important first step in forcing health care institutions to adopt a systematic approach to error reporting, detection, and control.
The Report lays out the strategies that a system shift requires: leadership; respect of human limitations; effective team functioning; anticipating the unexpected; and creating a learning environment for safety. It acknowledges the centrality of a strategy that combines regulatory and market incentives, to induce institutional attention to proper system management of risk. In the words of the Report, "[t]he committee's strategy for improving patient safety is for the external environment to create sufficient pressure to make errors so costly in terms of ability to conduct business in the marketplace, market share and reputation that the organization must take action."
Let me outline other lines of inquiry that might further the admirable goals of the Report.
First, patients are entitled to full and accurate reporting about the error rates of their institutions and providers. Movement in this direction has occurred, but slowly and with resistance from providers. It is clear however that patients like honesty and are angered by concealment. Patients as consumers are increasingly sophisticated and able to process outcomes data about medical treatments. The recent study of one Veterans Administration hospital, which has had a policy of disclosing injuries caused by accidents to the family and helping them file a claim, is encouraging. The study found that this policy of full disclosure of errors led to only a moderate level of pay-outs when compared to other VA hospitals. This is a radical change in current litigation approaches to patient injury, and deserves consideration. It suggests the need to look again at alterations in the tort system to combine disclosure with compensation.
Second, a system for compensation of patient injuries from medical error needs to be developed. Internalization of the economic costs of such patient injury provides sharp incentives for health care institutions to reduce error rates through system efforts. Some work has been done on models of enterprise liability for such injury, designed to refocus responsibility away from physicians and nurses and onto the hospital or other institution. The Report provides new impetus for demonstration projects to experiment with various models that change the operating structure of current malpractice litigation. A new look at early research by Havighurst and Tancredi, among others, may be fruitful.
Third, tighter integration of medical practice should be forced through the accreditation process. A team approach to medical practice, incorporating pharmacists and other providers, is likely to further reduce risks. The standards developed by the JCAHO and the NCQA need to rapidly incorporate the current findings of the Report, and increase the pressure on providers to redesign their systems to reduce risk.
The Report has forced us to face the reality that medicine is a complicated and dangerous business. We would not tolerate such a level of injury in any other industry and there is no reason to tolerate it in medicine. We can hope that in the future hospitals and providers may start to compete on the basis of low risk as well as high quality, a marketplace advance that will be good for all of us.
Nonpunitive Medication Error Reporting Systems
Alan C. Horowitz
Law Office of Alan Horowitz
Traditionally,
handling of medication errors suffered from two fatal flaws -- they were
underreported and were met with harsh sanctions. Clearly, the former is
an outgrowth of the latter. The literature is replete with reasons why
nurses, pharmacists, and physicians have tended to underreport medication
errors. Apart from professional pressure and personal feelings of guilt,
clinicians have been subjected to unpleasant employment situations (e.g.,
suspension or termination) and administrative actions such as license revocation
or suspension. These actions are exclusive of other potential civil remedies
such as medical malpractice.
Raising the ante for voluntary reporting of serious medication errors has been the troubling aspect of the criminalization, albeit infrequently, of medication errors. Recently, charges of criminally negligent homicide were brought against three nurses by a Colorado district attorney. In that tragic case, a one-day-old infant died as a consequence of not one, but rather a series of medication errors made by physicians, pharmacists, and nurses. Interestingly, only the nurses were indicted and subsequently charged in the criminal matter. (The pharmacist had accidentally prepared a ten-fold overdose of the prescribed medication.)
Punishing clinicians who make medication errors is akin to shooting flies with a shotgun. It is the wrong approach and most likely never succeeds in reaching its intended goal. Indeed, the punitive approach only fuels the natural inclination to underreport. In turn, underreporting raises serious and troubling concerns. If one accepts the premise that medication errors result from faulty systems, not faulty clinicians, then justification for a punitive approach becomes increasingly difficult. Arguably, punishing individuals avoids ascertaining the root causes that underlie medication errors.
Such root causes involve the entire system of medication delivery, implicating problems with order transmission, dispensing, and administration. Additionally, medication errors are frequently made as a result of look-alike/sound-alike names and similar packaging by the pharmaceutical industry. Nomenclature and labeling issues are very much a part of the overall system. Individually or collectively, it is components of these systems that lead to medication errors. Medication errors do not exist in a vacuum. They result from systems that lack sufficient safety mechanisms. If the system is flawed, is not the clinician set up for failure? Punishing clinicians does little if anything to improve the future safety of medication delivery. To the contrary, it ignores the underlying causes while serving as a disincentive for voluntary reporting. Unfortunately, the punitive approach hinders meaningful efforts at correcting the problem. The net result is one that permits similar serious and lethal mistakes to continue to occur.
Medicine can learn a valuable lesson from other industries. Following disasters such as Three Mile Island and the fatal space shuttle disaster, exhaustive investigations were conducted. The results in both cases pointed to the same conclusion -- it was not the fault of any one individual. Rather, inadequate safety systems failed to detect latent errors. Such is the case with medication errors.
Researchers have been attributing medication errors to approximately 100,000 deaths annually in the United States alone. For the last quarter of a century, studies have called for a nonpunitive approach to medication errors and a focus on systems analysis rather than assigning blame. Unfortunately, these pleas for a rational approach have largely been ignored by the healthcare community. However, when the Institute of Medicine (IOM) released its landmark study indicating that medication errors account for more deaths than automobile accidents, AIDS, or breast cancer, people took notice of two critical findings -- the magnitude of the problem and the call for a changing of the punitive climate. The IOM report quickly caught the attention of the Administration and Congress. That IOM report confirmed what pioneers in the field of medication error prevention have been arguing for years. In order to begin effective risk management aimed at reducing the number of serious medications errors, one must avoid the blame game.
For too long the healthcare industry has attempted to solve this problem by placing blame on individuals rather than examining the system. This knee-jerk reaction is as doomed to failure as it is ineffectual. An examination of the system moves in the opposite direction from blame (and punishment) towards corrective measures designed to improve overall safety. The nonpunitive systems approach that is employed in other sectors such as the aeronautics industry have demonstrable results.
There are two compelling rationales for moving towards a nonpunitive approach to medication error reporting: 1) the most competent clinicians can become involved in medication errors where the system is flawed; and 2) the degree of medication errors caused solely by physicians, pharmacists, and nurses who lack the requisite skill, knowledge and judgment is statistically insignificant. Even if one assumed that medication errors were caused by deficient clinicians, that ultimately begs the question of why there were not adequate safety nets in the system to prevent such mishaps.
In an attempt to demonstrate an enlightened nonpunitive approach to reporting medication errors, some hospitals and health systems have adopted "amnesty programs" and the ability of clinicians to anonymously report medication errors. While this represents a step in the right direction, it is insufficient. The mere term "amnesty" conjures images of forgiveness. This is little more than a vestige of the blame mentality. If somebody didn’t do something wrong, why is there a need for forgiveness? The problem of anonymous reporting is that it often prevents essential follow-up necessary for systems analysis with corresponding adaptations. Both approaches fail to miss the central issue.
Only when clinicians feel that they will not be blamed, hence punished, for reporting medication errors with serious adverse outcomes, will a climate that permits significant improvement be created. If punitive responses to medication errors are allowed to continue, clinicians will be less likely to report. The corollary of underreporting is that more medication misadventures will occur. In that case, the time-honored concept of primum non nocere (first do no harm) will be seriously undermined.
Proving the Impossible: Patient Safety and the Peer Review Privilege
Richard Warren Mithoff
and Janie L. Jordan
Mithoff & Jacks, L.L.P.
Houston, Texas
A
young man and his 20-year-old wife are expecting their first child. Their
families have gathered at the hospital to share in the joyous occasion
and wait anxiously just outside the delivery room door. As labor progresses,
the anesthesiologist, a member of an anesthesia group under contract with
the hospital, attempts to administer an epidural. Instead of injecting
anesthetic into the epidural space in the spinal canal, he pierces the
vena cava, a major vein running to the heart, causing the anesthetic to
travel immediately to the heart, and from there to the mother's brain.
The mother goes into cardiac arrest.
As the family watches through the doorway, nurses run in and out of the delivery room, dropping instruments and supplies in their haste. The anesthesiologist fails to remedy his life-threatening blunder. Finally, an alarm is raised, and two other physicians, the emergency room doctor and the on-call obstetrician, come to the delivery room to aid in the resuscitative effort. Unbelievably, none of the physicians are qualified to perform a caesarean section, and no effort is made to deliver the baby. The mother and her unborn full-term baby do not survive, and the family is left to deal with the needless loss of two lives.
This real life tragedy caused the Glickman and Johnson families to sue the parties involved, including the hospital for its negligent credentialing of the anesthesiologist. Jake Glickman v. South Park Medical Center Inc., No. 96-556,506 (99th Dist. Ct., Lubbock County, Tex. July 8, 1997). Through discovery, evidence was uncovered that the hospital knew the anesthesiologist was a threat to patient safety.
Unbeknownst to the expectant parents, but not to the hospital's director of anesthesia services, the anesthesiologist had a history of drug abuse. He may even have been under the influence of narcotics during the delivery. Evidence of the hospital's knowledge of this egregious misconduct, however, was protected from discovery by the peer review and hospital committee privileges. Thus, the families were denied the very evidence that would prove the hospital had been negligent in credentialing the anesthesiologist. In essence, the families had to prove what the hospital knew, without the ability to review any of the records or information that the hospital had considered in granting or re-granting the anesthesiologist his privileges.
Sadly, this Gordian knot is all too common where negligent credentialing claims are asserted, and the safety of patients is compromised as a consequence. Had it not been for the fortuitous discovery of a letter to his former girlfriend in which the anesthesiologist revealed his drug abuse, this information would have remained buried in hospital committee files, and the doctor would have continued to treat other unsuspecting patients. In this handwritten letter the anesthesiologist confessed to a history of drug abuse and recounted having been accused of "killing someone while under the influence of drugs." Other injured parties are unlikely to experience such good fortune.
Case law construing the Medical Practice Act, including the peer review and hospital committee privileges, insulate hospitals from their own negligence in selecting and retaining physicians, and thus do nothing to encourage hospitals to deny privileges to inept or impaired physicians. The Act contains provisions protecting physicians who serve on peer review committees from frivolous retaliatory suits by doctors whose privileges are limited or terminated. This law was intended to protect patients and ensure patient safety, but has been interpreted as requiring patients to prove that when a hospital extends privileges to an incompetent or impaired physician it acted with malice in doing so. As the Chief Justice and two Associate Justices of the Texas Supreme Court observed in their dissenting opinions in St. Luke's Episcopal Hosp. v. Agbor, 952 S.W.2d 503, 514 (Tex. 1997), this is an almost impossible burden, particularly when the hospital's lawyers also take the position that the patient must make his or her proof without being able to obtain any of the hospital's credentialing files on the physician in question. In order to overcome the peer review and hospital committee privileges, then, an injured patient must show that a hospital credentialed its doctors "with either the intent to harm patients or with such reckless disregard for their welfare as to establish malice," and yet are denied the wherewithal to satisfy this unduly burdensome standard. Agbor, 952 S.W.2d at 511 (Phillips, C.J., dissenting). The threat to patient safety from the irresponsible and untrammeled application of these privileges is incalculable.
As Justice Cornyn noted in his Agbor dissent, because patients do not have the same ready access to information, they "must rely on hospitals to verify the competency of physicians" and ensure patient safety. Id. at 514. Yet, the current state of the law, which effectively keeps all relevant information secret, removes any impetus for the hospital to police those to whom it grants privileges. This position clearly conflicts with current medical ethical standards, in that "[p]hysicians who are involved in the granting, denying, or termination of hospital privileges have an ethical responsibility to be guided primarily by concern for the welfare and best interests of patients in discharging this responsibility." Code of Medical Ethics § 4.07 (American Medical Association 1997). Recent cases, however, do nothing to foster this guiding principle. As the Glickman case so aptly demonstrates, the procedures followed and decisions made by peer review and hospital committees can have tragic consequences for patient safety.
The Glickman family recovered $10.5 million, the maximum recovery allowed by statute for a medical malpractice death case, and obtained a final judgment requiring, among other reforms, that the hospital demand its physicians submit to random drug-testing. In addition, the Chief Executive Officer of the hospital joined Mr. Glickman in advocating that the legislature reconsider whether disclosure is required of peer review committee records which contain information about a physician that potentially affects the health and safety of patients. Had the plaintiffs not received the incriminating letter from another source, however, the peer review and hospital committee privileges likely would have ensured the malfeasance of the hospital and the drug-abusing anesthesiologist could continue unabated.
Consideration must be given to revising the applicable Texas statutes so that disclosure is required in discovery in civil actions of peer review committee records which contain information about a physician that potentially affects the health and safety of patients. Moreover, hospitals should be held liable when they negligently credential physicians, and their liability should not be predicated on the impossible standard of showing "malice." Such a revision would give equal consideration to patients, physicians and hospitals alike, while still maintaining the integrity of the original legislative intent underlying the privileges, to protect physicians who report threats to patient safety and the practice of medicine.
Reducing Adverse Events in Healthcare: Elements of an Effective System
Charles A. Mowll
Executive Vice President
Business Development, Government
and External Relations
Joint Commission on Accreditation
of Healthcare Organizations
The
Institute of Medicine, in its recent report To Err is Human - Building
a Safer Health System, suggests that "preventing errors means designing
the health care system at all levels to make it safer." The IOM recommends
the adoption of a four-tiered approach to improving patient safety and
reducing medical errors including the creation of a national center for
patient safety that would lead to enhanced knowledge about safety. Other
features of the IOM proposal include strong mandatory reporting efforts,
raising standards and expectations through the activities of oversight
groups, and creating safety systems within health care organizations. While
the IOM recommendations are, in themselves, necessary attributes of an
effective systemic and national
approach to improving patient safety, they are lacking other essential processes that are integrally necessary to achievement of the desired result, that is, a significant reduction in the level of medical errors and resultant adverse events. The elements of an effective national system of monitoring and reducing adverse events in the healthcare system include 1) uniform definitions and taxonomy of adverse events, 2) consistently thorough processes for identifying, reporting, and analyzing events within healthcare organizations, 3) national data collection, 4) intensive assessment of each event, 5) implementation of corrective action and prevention strategies, 6) dissemination of lessons learned developed form a national database of reported events, and 7) oversight, standards setting and monitoring.
1. Uniform Definitions and Taxonomy - A 1999 study conducted by the Joint Commission of state licensure agency efforts to monitor and collect information about adverse events in healthcare organizations revealed that there is wide variation among the states regarding the types of events being reported, whether the reporting is required or not, and the types of organizations, for example, hospitals, ambulatory surgery centers, nursing homes, that are affected by the state’s requirements. The New York State Department of Health has required the reporting of incidents and adverse events by hospitals since 1985. Their current system, the New York Patient Occurrence Reporting and Tracking System, or NYPORTS, receives approximately 18,000 incident reports and 1,100 adverse event reports, annually. Working through a NYPORTS advisory group, the state has developed a taxonomy to guide hospital reporting of events, including an "Include/Exclude" listing of events and attendant reporting codes. Hospitals in New York have generally found the specificity of this approach quite helpful in defining the types of events to be reported. To facilitate uniform collection and reporting of adverse event information, to establish a credible baseline of information regarding the prevalence of adverse events and to produce meaningful lessons learned advisories, national standardized definitions and a reporting taxonomy need to be developed.
2. Thorough Process for Identifying, Reporting and Analyzing Events - Medical staff committees, risk managers, quality control or improvement staff, nurse management, administration and the organization’s legal counsel may, at some time, be involved in a healthcare organization’s response to an adverse event. Peer review, quality assurance or improvement, and morbidity and mortality committees are often the venue for facilitating the open and candid review of the nature and causes of adverse events. With the potential existence of multiple levels of responsibility and inquiry, vagaries in definition, fear of retribution, and the potential for conflict in jurisdiction, it is critically important that the leadership of the healthcare organization clearly articulate the planned coordination of patient safety activities. Leaders in healthcare organizations should provide for the identification of adverse events by anyone in the organization, in a common format, reported to a centralized point of contact in the organization, immediately following or upon discovery of the event.
Moreover, healthcare organizations should develop and maintain proactive patient safety systems that provide for the centralized collection and analysis of reports of adverse events that have occurred anywhere in the organization. A decentralized approach does not facilitate the development and refinement of the skills necessary to conduct intensive assessments of adverse events. Similarly, a decentralized approach does not provide for the aggregation and analysis of all reported events to look for trends and effective preventive strategies that might apply to forming reduction strategies for other types of events. The leadership of the organization should be intimately familiar with the nature and number of events that have occurred, be driving the organization’s effort to prevent the reoccurrence of adverse events, and ensure the effectiveness of the organization’s process for identifying, reporting, analyzing, and preventing adverse events.
3. National Data Collection - I was speaking to a group of hospital risk managers last year on the subject of determining trends in the occurrence of adverse events when one of the managers said that his hospital had experienced only one potassium chloride related adverse event in the last year and that he had not identified this event as a trend that would require the implementation of a risk reduction strategy. I reported that the Joint Commission had received eleven reports of a misadministration of potassium chloride through its voluntary national reporting system. These eleven reported adverse events all resulted in the patient’s death, and in fact, we considered this information indicative of an undesirable national trend worthy of a Sentinel Event Alert distributed to all Joint Commission accredited organizations. National aggregation of event-related information including the analysis of the underlying causes of the event and the risk reduction strategies employed by organizations that have experienced events can be effective in reducing the reoccurrence of events. Since the publication of the Alert related to Potassium Chloride misadministration, only one adverse event has been reported to the Joint Commission. Of the more than 700 adverse events reported to the Joint Commission, 20 percent related to inpatient suicide, while medication errors represented 15 percent, operative complications 10 percent, and wrong-site surgery 8 percent. While a single occurrence of one of these events at a single healthcare organization may not seem like a trend requiring corrective action, the national aggregation of this data, albeit, limited by the voluntary nature of the current reporting system, has indicated adverse event trending that has been of grave concern. Lessons learned communications (Sentinel Event Alerts) were developed and nationally distributed with the hope of sharing information that will drive performance improvement in healthcare organizations.
4. Conducting an Intensive Assessment - The foundation of knowledge necessary to the development of effective risk reduction or corrective action plans to reduce medical errors and their negative effect on patient outcomes is achieved through the completion of an intensive assessment to determine the root causes of each serious adverse event. Healthcare organizations often address only the proximate cause relating to human error that contributed to the event but fail to address latent systems or process failures adequately. A thorough and credible root cause analysis can provide the analytic framework for a detailed analysis of the underlying system and process failures that might have been contributing factors that facilitated the adverse event. The airline industry utilizes root cause analysis to analyze both near misses and crashes. The results of the National Transportation Safety Board analyses are publicly disclosed and can be found on the Internet at ntsb.gov. The Department of Energy also requires the completion of root cause analyses of adverse events as an element of their Occurrence Reporting and Processing System. The DOE adverse occurrence database contains over 40,000 cases reported since 1988 and now receive reports of events at a rate of 3,000 a year. Occurrence Reports identify the related root causes of the event, generic implications for the DOE system, and the need for corrective action. DOE Occurrence Reports are distributed as lessons learned to all DOE facilities to help prevent similar events and to facilitate subsequent event analysis. DOE Occurrence Reports are available for in person review at each DOE site or through the Freedom of Information Act at DOE Headquarters in Washington, DC. Healthcare organizations accredited by the Joint Commission are required to perform a root cause analysis on all adverse events with some limitations. Surprisingly, while approximately 20 states require the reporting of some types of adverse events and the completion of a corrective action plan, most do not require the conduct of a thorough root cause analysis. It could be argued that the development of an action plan absent a root cause analysis is a superficial and potentially dangerous course of action.
5. Corrective Actions - Healthcare organizations should design their risk reduction strategies or corrective action plans to address specific system and process failures that need improvement to prevent or reduce the likelihood of the reoccurrence of an adverse event. The remedial action plan should define the goals for improvement and identify the specific systems design or redesign objectives. Performance measures should also be identified and linked to the action plan so that the plan’s success can be monitored over time. The Joint Commission requires the development of an action plan in conjunction with the conduct of a root cause analysis of serious adverse events.
6. Dissemination of Lessons Learned - As described above, the attractive byproduct of a national system of collection and aggregation of adverse event-related information (including descriptive information about the type, nature, causes, and related effective corrective actions of adverse events) is the capability of developing and distributing informative lessons learned advisories to healthcare organizations. As demonstrated in the airline and energy industries, sharing lessons learned information is thought to contribute to the reduction of adverse events by providing advice or recommendations based on the experience of those organizations that have identified, reported, and analyzed adverse events.
7. Oversight and Monitoring Activities - National standard setting, assisting healthcare organizations effectively respond to adverse events, monitoring the implementation of corrective actions, serving as a central repository for adverse event-related information, and disseminating lessons learned advisories as a derivative of reported information are functions integral to an effective adverse event reduction system. Today, these activities are shared between state and federal healthcare licensing and certification agencies and private accrediting bodies. The absence of federal mandated protections from discovery or disclosure for the development of root cause analyses (and the sharing of these analyses with private accrediting organizations like the Joint Commission) has retarded both the identification and reporting of adverse events by healthcare organizations. Any federal legislative initiative focused on increasing the identification and reporting of adverse events in the healthcare system must be supported by and coupled with passage of preemptive federal legislation that establishes the necessary protections from discovery and disclosure (including exemption from the Freedom of Information Act provisions) for root cause analyses developed in response to an adverse event and shared with accrediting bodies.
Reporting Medical Errors - Me?
Connie J. Wallace
Assistant Vice President
Business Practices Officer
Methodist Healthcare System
Patient
safety concerns have been a popular news item recently. Politicians have
quickly recognized patient safety as a "winner" and have already begun
hearings on ways to reduce medical error rates. The basis of any successful
program to decrease medical errors is a solid, reliable error reporting
system. Implementing a national, mandatory reporting system that provides
complete and reliable data is a major challenge. This article outlines
some obstacles from the viewpoint of a hospital nurse and risk manager.
Nursing leadership, risk managers, and quality program directors have, for many years, encouraged reports of medical incidents as means to learn the problems faced by nurses; to develop valid educational and system-based corrective action plans to improve patient care; to identify potential claims so efforts to resolve them can begin immediately; and to fulfill insurance reporting requirements.
Efforts to convince the nurses that their filing an incident report is an important part of a successful quality improvement and risk management program to reduce error have met with varied success. The more successful aspects of incident reporting systems address the actual error with an untoward outcome rather than the "near-miss" or the error with no untoward outcome. This is true, in part, because the nurse and other health care providers need assistance dealing with these unfortunate situations.
To increase nurses' support of a reporting system with a broader focus would require fundamental cultural change. Health care must move from a predominate focus on blame to a focus on improvement, from a "gotcha" mentality to a more supportive, developmental environment
In some hospital environments, nurses who submit incident reports (reports of medical errors) risk subjecting themselves to discipline and retaliation. The mere existence of a reporting system may expose the nurse to a physician's shouts of "I want an incident report on him!"
When self-reporting a medical error, a nurse risks hospital reprisals. The licensing agency may impose further discipline. When a nurse fulfills his or her professional duty, whether imposed by the law, the profession's standards, or self-motivation, to report a medical error committed by a nurse colleague, he or she risks ostracism and retaliation. And yet, if that reporting nurse files only an internal hospital report, he may have violated nursing ethics, if not a mandatory reporting law. Blamed if they report; blamed if they don't. Dreaded lawsuits are another reason not to submit an incident report. Certainly, incident reports do not cause lawsuits, but they may be used against the nurse in litigation.
Steps to encourage incident reporting include changing the culture and providing legal protections. Hospitals could demonstrate the value of incident reports to the quality and risk programs, make it easier to submit incident reports, actively prohibit retaliation by physicians and nurse supervisors, and provide paid time allowances for quality improvement activities, including nursing peer review and nursing competency training. How an institution allocates its money reveals its priorities! Regulatory agencies could provide for anonymous reporting and add sessions on quality improvement processes to the continuing education requirements. Laws could provide protection for whistleblowers. Legal protections for incident reports and quality improvement activities could be strengthened.
Hospital nurses are caring people concerned about patient welfare. Yet, good nurses do make mistakes. The culture should encourage learning and prevention, not blame.
Cynthia Douglass, R.N.,
J.D. candidate 2001 at the University of Houston Law Center, contributed
to this article. Ms. Douglass is working at The Methodist Hospital as part
of the Health Law & Policy Institute's Health Law Clinic program.