Institute of Medicine Report Focuses Legislative Attention on Medical Errors
Legislative Affairs Feature -- March 2000
By Ken Ortolon
When the national Institute of Medicine (IOM) reported last year that between 44,000 and 98,000 Americans die every year as a result of medical errors, few health professionals were surprised. While there is considerable disagreement over the magnitude and accuracy of the IOM's estimates (it was based on studies of errors occurring in only three states), physicians, nurses, pharmacists, and other health professionals have been attempting to focus national attention on the problem of medical errors for some time.
In 1997, the American Medical Association established the National Patient Safety Foundation (NPSF) to attack the systemic nature of medical mistakes. More recently, the nursing and pharmacy professions, as well as the hospital industry, have been looking at the problem.
But the IOM report, entitled "To Err Is Human: Building a Safer Health System," seems to have galvanized both public and legislative attention to the issue of medical errors. And leaders throughout the health care industry say that attention is almost certain to lead to some legislative action to address the problem both at the congressional and state legislative levels.
"Because of all the media attention and the attention this report is receiving from elected officials, somebody's going to act," said Fort Worth surgeon Robert W. Sloane, Jr, MD, chair of the Texas Medical Association Council on Legislation. "I believe it has always been the physicians and health professionals who best know where the system needs to be changed and where improvements can be made."
Challenging the findings
According to a report delivered to the TMA Board of Trustees last month by TMA staff members, the IOM report has a serious methodological problem.
The data used to derive the figures that as many as 98,000 persons die each year from medical errors are based on information from two large studies. The first study is from an unpublished article using 1992 data from Colorado and Utah. The reported death rate in those two states is 6.6%. The second is from New York using 1984 data that reported a much higher percentage of adverse events (13.6%). The authors of the study then extrapolated these numbers to total hospital admissions in 1997 to arrive at a figure as high as 98,000.
"The data to make this argument are old and based on a limited study of just three states," said the staff report to the TMA Trustees, prepared by Karen Batory, director of the TMA Division of Public Health and Quality. "Moreover, the trend in medical errors from published sources that are quoted in the IOM report has actually decreased from 4.6% in 1977 to 3.75% in 1984 to 2.9% in 1992. Deaths from medical errors show the most dramatic improvement. Most importantly, this decline in error rate has occurred in the absence of mandatory reporting!"
In an unpublished study, "The Patient Safety Crisis: An Analysis of the Science and Rhetoric of the American Patient Safety Movement," John Dale Dunn, MD, JD, of Brownwood, says the medical error rate based on data from the Texas Medical Foundation (TMF) contradicts the IOM report findings. Dr Dunn is a consultant to the TMA Patient-Physician Advocacy Committee.
Based on review of data from more than 300,000 charts in a multiyear study of all nonfederal hospitals in Texas, Dr Dunn says, TMF data suggest that the negligence rates are one tenth of that reported in the New York study. Furthermore, the TMF analysis was far more exhaustive in the number of charts pulled --300,000 (data over a 3-year period, 1989-1992) versus 31,000 inpatient records in the New York study using 1984 data. The TMF data are also more recent than the data in the New York study. TMF's data and methodology, according to Dr Dunn, are much better than the New York data, which showed the highest error rate of all studies identified in the IOM report.
Leading the parade
Kim Ross, vice president for public policy for TMA, says physicians and other health professionals have expressed concern for some time about systemic problems that can put patients at risk, particularly with regard to more obvious situations like medication-related errors or misreading of charts.
What may have come as a surprise is how quickly Congress and President Clinton jumped on the issue. Even though the NPSF, federal health-related agencies such as the Veterans Administration, and others were already looking at the issue and taking steps to reduce mistakes, the politicians in Washington, DC, leapt immediately into action.
On December 13, 1999, just 2 weeks after release of the IOM report, the Subcommittee on Labor, Health and Human Services, Education and Related Agencies of the Senate Committee on Appropriations held hearings. President Clinton also acted quickly, appointing a presidential task force to examine the problem and recommend solutions within 60 days.
And it is believed that Sen Edward M. Kennedy (D-Mass) already is preparing legislation. Medicine has garnered substantial credibility from patient advocacy organizations during their fights over patients' rights during the past several years. Consequently, Senator Kennedy and other congressional leaders have sought input and collaboration from AMA and several state medical associations in developing an appropriate response to the IOM report.
"Medicine has come a long way from the old days of doctor-baiting and political ambush over questions involving patient safety," Mr Ross said . "This is yet another opportunity to work in a positive, constructive fashion. In other words, fix the problem and not the blame."
Joe DaSilva, senior vice president for public affairs at the Texas Hospital Association (THA), says the issue is "politically sellable. It's a dramatic issue, it plays on the fears of the public, and it creates a reason for bigger government."
Mobilizing to respond
With Congress already working on the issue and the potential for the Texas Legislature to examine it in 2001, TMA is preparing to enter the debate.
"The Institute of Medicine report should open up a lot of opportunities for physicians to do what they have been addressing in the Texas Legislature for over a decade -- and that's improve the system," said Alfred Gilchrist, TMA's director of legislative affairs. "TMA has practically begged the legislature on a biennial basis to adequately fund the Texas State Board of Medical Examiners and has systematically updated and revised the enforcement provisions of the Medical Practice Act in coordination with the board's concerns for the last 10 years."
Toward that end, TMA has accelerated its efforts. In February, the TMA Council on Legislation asked TMA trustees to designate the Patient-Physician Advocacy Committee to take the lead role to identify any action that the state legislature and health-related agencies can take, and to coordinate their efforts with AMA and other national health care organizations. The Patient-Physician Advocacy Committee would coordinate expertise from other TMA councils and committees, as well as medical specialty societies. It also would liaison with a coalition of health care professionals from TMA, THA, Texas Nurses Association, Texas Pharmacy Association, and others to examine the problem from a broader, health-industry-wide perspective. These organizations have worked together on these and related health care issues for the past decade.
Bugs in the system
The IOM report focuses mainly on inpatient errors that occur in hospitals and other health care facilities, particularly on errors resulting from system or process failures rather than individual negligence. The report points to medication-related errors as one of the most frequent problems in hospitals.
Some of the blame may rest on the shoulders of national efforts to contain health care costs, some experts say. Clair Jordan, executive director of the Texas Nurses Association, says hospital staffing has become a major concern of her organization. Nurse-to-patient ratios in some hospital intensive care units, for example, have gone from 1 or 2 patients per nurse to as high as 5 patients per nurse, she says.
Mr Ross says managed care is at least partly to blame for that problem. "The double whammy of the cost cutting of managed care with its powerful disincentives toward inpatient care and the starving down of reimbursement to hospitals and doctors has had an impact," he said.
Diane Ginsburg, MS, RPh, immediate past president of the Texas Society of Health-System Pharmacists, agrees. "Health systems have been running in the red," she said. "I think managed care has had an impact on that."
Jerry Patterson, executive director of the Texas Association of Health Plans, says managed care is not the culprit.
"I think it's reasonable to assume that you reach a point where continuing to ramp down hospital reimbursements has a negative effect. And, of course, the major ramping down of hospital reimbursements has not been managed care. It's been federal compensation, whether it's the Balanced Budget Act, whether it's Medicare reimbursement, whether it's Medicaid," he said.
Managed care has had a positive impact on health care accountability, says Ms Ginsburg, who also is a clinical associate professor at The University of Texas at Austin College of Pharmacy. "However, we sometimes cut too many positions and cut too much to try to affect the bottom line, and patient safety suffers."
Four tiers to safety
The IOM report recommends a four-tiered approach to solving the problem of medical errors:
- Establishing a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety,
- Identifying and learning from errors through immediate and strong mandatory reporting efforts,
- Raising standards and expectations for safety improvement, and
- Creating safety systems inside health care organizations.
The report includes several recommendations that could directly lead to congressional or state legislative action. The first calls for the creation of a national Center for Patient Safety within the federal Agency for Health Care Policy and Research to set national goals for patient safety, track progress in meeting those goals, and issue an annual report to the president and Congress. It also would develop knowledge and understanding of errors in health care by developing a research agenda, funding centers for excellence, evaluating methods for identifying and preventing errors, and funding communication activities to improve patient safety.
The report recommends initial annual funding for the center of $30 million to $35 million. Officials with TMA, TNA, and TPA all say they would support creation of such a center.
There is less agreement, however, on IOM recommendations for a nationwide mandatory reporting system to collect information about adverse events that result in death or serious harm, and urging state health professional licensing boards to implement periodic reexamination and relicensing of physicians, nurses, and other key health care providers.
While health professionals support the idea of reporting medical errors and using that data to help prevent future mistakes, they are wary of how such a system would be implemented. In testimony at the Senate subcommittee hearing in December, Bryan family physician Nancy W. Dickey, MD, warned that past federal efforts to collect such data have had a negative effect on efforts to create an environment of trust that fosters open communication about errors.
"It is our policy to encourage the development of guidelines for a national reporting system," said Dr Dickey, past president of AMA and past chair of the NPSF Board of Directors. "We emphasize that such guidelines should, at a minimum, include a nonpunitive mechanism for reporting incidents, post-incident evaluations for prevention of subsequent occurrences, and federally guaranteed legislative protection from discovery for all aspects of this information."
Another problem with mandatory reporting is that the process will be timely, expensive, and even unnecessary if objectives for reporting are unclear and duplicative, the TMA staff report to the Board of Trustees said. Nationally, mechanisms are already in place to address preventing medical errors, including the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Institute for Safe Medication Practices, and peer review organizations in the Medicare program. In Texas, there is the work of TMF, Texas Health Quality Alliance, peer review committees in hospitals and managed care plans, and possibly the Texas Health Information Council.
The IOM report states that at least a third of states already have adverse event reporting systems, and IOM interviewed 13 of the states. No evidence exists to show that medical error rates are lower in those states with mandatory reporting than in states without mandatory reporting. It is not clear that a mandatory reporting system will eliminate medical errors or even target a way to improve systems of care.
An effective alternative to mandatory reporting is developing research efforts to show an evidence-based approach to focus on studying and improving the entire process of care, the TMA staff report said. "Certainly, the efforts of the Agency for Health Care Research and Quality to publish reports showing what works and what doesn't based on scientific study can be applied to clinical practice. That is the philosophy of the Texas Health Quality Institute, which seeks to provide physicians with useful tools to improve processes of care in their practice."
Bruce Levy, MD, JD, executive director of the Texas State Board of Medical Examiners, says some confidentiality has to be built into the reporting system so doctors and nurses can report problems without fear of being disciplined or sued.
"When cases of actual negligence exist, the licensing boards are empowered to deal with them," Dr Levy said. "And this board has effectively dealt with quality of care cases. I think that's pretty well documented. But system errors are things that we need to be looking at. We must design a system that allows doctors and hospitals to report without fear of being disciplined so we may learn how the mistakes are made, fix them, and make the practice of medicine much safer."
Testing one, two, three
As for periodic reexamination and relicensing of health care professionals, there appears to be little support, even among those involved in health professional licensing or quality improvement efforts. Temple cardiologist Jim Rohack, MD, TMA president-elect, says paper-and-pencil tests have not been effective in determining continued competency.
"All a test really does is measure a body of knowledge," Dr Rohack said. "When one looks at competency, it's not necessarily, do you have a body of knowledge? It's, do you know how to apply it, how to take the knowledge and use it in the correct way?"
Rather than periodically retesting every licensed health care professional, a better approach may be to retest those who have demonstrated some pattern of deficiency, suggests Phil Dunne, executive director of TMF.
Ms Ginsburg says the solution may lie not with the licensing board but with certification boards, such as those of the various medical specialties. Specialty board certification is no longer good for life but requires periodic recertification, she points out.
"There needs to be some system to ensure that practitioners are qualified and competent," she said. "In medical specialties, recertification has been done now for quite a few years. I think that's coming in other practices. I don't necessarily, personally think that's bad."
The role of quality improvement organizations in reducing medical errors
By D. Clifford Burross, MD, president, Texas Medical Foundation
Through its recent report, the Institute of Medicine (IOM) has issued a challenge to organizations committed to health care quality. Reducing medical errors by 50% over the next 5 years, as advocated by the report, will require action by a coalition of private and public entities across the health care spectrum. As a Medicare quality improvement organization (QIO), the Texas Medical Foundation (TMF) contributes to this effort through educational and quality improvement activities with health care professionals.
Preventable errors are unintended products of flawed systems that operate throughout the health care industry. Health care systems are complex and interdependent, thus presenting opportunities for failure and defying simple solutions. In the chapter "Why Do Errors Happen?" the report describes a case study of a medication error during surgery. The error resulted from failures in the process of care, including the difficulty of programming and using multiple infusion devices, each containing different medications at different concentrations; poor communication among the care team; and insufficient training of new team members (1, pp 43-48).
The IOM report points to preventable medical errors in every area, from wrong-site surgery in the hospital or ambulatory setting to errors in drug dispensation at the retail pharmacy. Because errors occur throughout the health care system, TMF agrees with the IOM report that "preventing errors and improving safety for patients require a systems approach in order to modify the conditions that contribute to errors" (1, p 42). The health care industry must examine systems of care to discover where errors take place and build processes that ensure patient safety into those systems.
TMF has long promoted a systems approach to health care quality improvement. Under contract with the Health Care Financing Administration (HCFA), QIOs work with the health care community to identify opportunities for improving clinical processes and implementing systems changes to bring about measurable improvements in care delivered to Medicare beneficiaries. In this model, Texas health care professionals (with assistance and support from TMF if requested) collect and analyze baseline data, identify opportunities for improvement, implement changes to processes of care, and conduct periodic remeasurement to determine the degree of improvement and make further changes as indicated.
The systems change method that TMF promotes is the same approach necessary for reducing medical errors. In fact, stripped to its basic elements, TMF's quality improvement work can be summarized as a collaborative effort to reduce medical errors of omission. For example, clinical trials have demonstrated that using angiotensin-converting enzyme (ACE) inhibitors decreases the risk of death in congestive heart failure (CHF) patients who were not contraindicated for this therapy (2). However, a 1999 random sample of 620 CHF cases in Texas suggests that fewer than 62% of eligible patients were discharged on ACE inhibitors (3).
Failure to deliver this proven therapy to all eligible CHF patients constitutes a medical error of omission. Errors of omission occur when health care professionals fail to take action that would benefit the patient. By designing systems to ensure that eligible CHF patients receive appropriate treatment, hospitals can improve care by reducing errors of omission. While errors of omission are not often featured on the evening news, they can cause unnecessary harm to patients, and they are preventable through the systems change approach.
Many issues still must be addressed before it is possible to determine the extent of the role that QIOs might play in reducing medical errors. Chief among these is confidentiality as it relates to voluntary reporting of medical error data by health care professionals. Patient case data released to QIOs for medical peer review or quality improvement are protected from legal discovery. However, no blanket protection exists nationwide for data related to medical errors and "near misses." This is particularly true for errors of commission where a patient is harmed as the result of a physician's action, for example, injury that results from a prescription error. Most of the medical errors discussed in the IOM report are of this type.
As the report points out, the fear of punishment and litigation has a chilling effect on the reporting of medical errors, which results in a lack of data from which to learn lessons and design process improvements. Recommendation 6.1 of the report calls for Congress to "pass legislation to extend peer review protections to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and quality" (1, p 96). Such a provision would be an important step toward creating an atmosphere where data can be reported and used in a continuous quality improvement framework. It also might allow QIOs more latitude in using their data management expertise to assist providers with patient safety improvement activities.
In the meantime, HCFA is preparing for an expanded role in this effort by soliciting information from the QIOs on possible projects to address medical errors. TMF is investigating this topic for possible implementation as a quality improvement initiative in Texas.
Ensuring patient safety is central to health care quality. Therefore, TMF and QIOs across the country will continue to play a significant role in helping to reduce the incidence of medical errors.
A former TMA president, Dr Burross is the director of the Wichita Falls Family Practice Residency Program.
- Kohn LT, Corrigan JM, Donaldson, MS, eds. To Err is Human -- Building a Safer Health System. Committee on Quality of Health Care in America, Institute of Medicine. Washington DC: National Academy Press; 1999..
- Stevenson WG, Stevenson LW, Middlekauff HR, et al. Improving survival for patients with advanced heart failure: a study of 737 consecutive patients. J Am Coll Cardiol. 1995;26:1417-1423.
- Congestive Heart Failure Project, A Texas Medical Foundation White Paper. 1999:4-5.
TMA Advantage: TMA quality watchdogs
By Monica Maldonado
When it comes to undertaking meaningful initiatives to help physicians set baseline standards for the quality of patient care, the Texas Medical Association is in the forefront. In 1997, for example, it joined the Texas Osteopathic Medical Association and the Texas Medical Foundation (TMF) in establishing the Texas Health Quality Institute (THQI), which offers physicians a central information center for the collection, analysis, and reporting of information related to quality studies.
"The resources for physicians to set up the process of collecting data are not readily available, so what we do is offer them a series of tools they can use to evaluate their current level of care," said Josie Williams, MD, of Austin, THQI chair.
Among the THQI goals are to create an information exchange on outcomes research, develop a quality management plan for physician networks, provide access to all quality data it obtains, and help physicians meet accreditation requirements of the National Committee for Quality Assurance or the Joint Commission on Accreditation of Healthcare Organizations.
For more information, call Karen Batory, director of the TMA Division of Public Health and Quality, at (800) 880-1300, ext 1403, or (512) 370-1403; or e-mail firstname.lastname@example.org .
TMF, chartered by TMA in 1971 as a designated peer review organization, contracts with the Health Care Financing Administration (HCFA) to demonstrate measurable levels of improvement for six major disease topics through the Health Care Quality Improvement Program. (See "The Role of Quality Improvement Organizations in Reducing Medical Errors.") Those six areas include acute myocardial infarction, congestive heart failure, stroke/transient ischemic attack/atrial fibrillation, pneumonia/influenza, diabetes, and breast cancer.
"The point is, all physicians know that patients who suffer acute myocardial infarction should be given aspirin and beta blockers immediately after the incident," said Carol McCauley, director of health services improvement for TMF, "and it's not that physicians decide not to do these things. We just try to convince them and hospitals that they need systems that don't depend on someone's memory."
To that end, TMF acts as a consultant to hospitals and individual physicians to establish and attain performance benchmarks for care. In its latest contract, which began February 1, TMF offered its services to all Texas hospitals that admit Medicare patients (about 375), as well as to all fee-for-service physicians. Those who don't volunteer to participate can still receive information and educational material from TMF.
Those who do participate use TMF's data collection tools, such as medical record templates and flow sheets, to measure their level of improvement. The organization makes information from across the state available to each participant so that each can compare their standing. For more information, contact TMF at (800) 725-9216.
TMA also has paired with the American Heart Association in the HeartCare Partnership project, a continuing medical education course designed to improve risk factor management in patients with coronary artery disease. "The HeartCare program goes further than traditional continuing medical education programs because it offers more than straightforward lectures," said Bridget Butler, project coordinator at TMA. Participants are asked to perform a baseline chart audit before attending a HeartCare Partnership workshop, where physicians help them design a practical patient management program for their office or hospital. Finally, follow-up chart audits are performed at designated times throughout the ensuing year to track improvement.
TMA also offers the Education for Physicians on End-of-Life Care (EPEC) program, which focuses on the essential clinical competencies for end-of-life care. Its core curriculum is designed to give participants (via lectures, videos, small group discussions, and practical exercises) the basic knowledge to effectively and legally provide comfort for dying patients. Kristen Brockman, program coordinator, says Texas was the first to offer EPEC at a statewide level at TexMed '99.
For the past 5 years, TMA's Physician Oncology Education Program (POEP) has been tracking data on treatment and screening of cancer in Texas. Through a series of surveys, POEP compiles a database that measures physician practices and oncology education needs. The results are used to develop educational materials that POEP shares with policymakers and continuing medical education directors throughout the state.
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