By Christopher Guadagnino, Ph.D.

Kaiser chairman and IOM committee member David M. Lawrence, M.D.

Published February 2000

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A slew of proposals and initiatives designed to reduce medical errors has received a tremendous amount of attention lately and health care professionals and institutions can surely not afford to ignore them.

The release of the Institute of Medicine (IOM) report outlining the magnitude of medical errors in the U.S. and offering a set of solutions has put the issue on the map in a way that similar studies over the past ten years have failed to do, spurring the creation of several error reduction initiatives and bringing to public attention a number of programs that have already been in place.

The prospect of curtailing preventable harm to patients is obviously desirable to every physician. Less obvious are the impacts those initiatives are likely to have—positive and otherwise—on the way that health care systems are organized and care is delivered, on physicians’ clinical decision-making authority, on patient choice of physicians and hospitals, and even on medical malpractice rates and lawsuits.

No longer confined to journal articles and theoretical assumptions, a nationwide focus on reducing medical errors will clarify for the public and for policymakers that improving quality of care has a price tag, just as medical errors have a price tag.

IOM Committee Report

Formed in June 1998, the IOM Quality of Health Care in America Committee released the report, To Err Is Human: Building a Safer Health System, late last year. The report notes that at least 44,000 and as many as 98,000 Americans die each year as a result of medical errors, exceeding deaths caused by either automobile accidents, breast cancer or AIDS, and that the total national health care cost of preventable medical errors resulting in patient injury is between $8.5 billion and $14.5 billion.

The report says that the decentralized and fragmented nature of the nation’s health care delivery system, fraught with rigidly-defined areas of specialization and multiple providers in different settings, contributes to unsafe conditions for patients, serves as an impediment to efforts to improve safety and makes it difficult to implement improved clinical information systems capable of providing timely access to complete patient information.

The report states that its recommendations are designed to "create sufficient pressure to make errors costly to health care organizations and providers, so they are compelled to take action to improve safety," setting a target of 50 percent reduction in errors over five years.

The report lays out a four-tiered approach to error reduction, the first calling on Congress to create a Center for Patient Safety within the Agency for Health Care Policy and Research to set national goals, track progress and issue an annual report on patient safety. The Center would also develop a research agenda, fund centers of excellence and fund dissemination of patient safety information to consumers.

The second set of recommendations calls for the establishment of a nationwide mandatory reporting system whereby state governments collect standardized information about adverse events that result in death or serious harm. The information would be publicly disclosed and initially required of hospitals, eventually extending to ambulatory care and other institutional settings. To that end, Congress should designate a Forum for Health Care Quality Measurement and Reporting to promulgate and maintain a core set of reporting standards and taxonomy to be used by states. The mandatory reporting system should be accompanied by voluntary reporting of errors leading to less serious adverse events, the IOM report says, with federal legislation to protect those data from public disclosure and use in litigation in order to encourage reporting.

The report’s third set of recommendations calls on licensing, certification and accreditation agencies, as well as public and private purchasers, to develop and strengthen patient safety standards and performance expectations for health care organizations. The FDA should require drug companies to design drug labels to maximize safety and to identify and eliminate look-alike and sound-alike drug names that may lead to mistaken substitutions.

Finally, the report recommends that enhanced patient safety programs be implemented within health care organizations at the delivery level, such as using non-punitive error reporting systems; standardizing equipment, supplies and processes; and adopting proven medication safety practices.

The report’s recommendations represent a balancing act to satisfy competing objectives: the need to levy strong incentives on health care organizations to make systemic changes to protect patients versus the need to encourage providers to participate in error reporting and reduction efforts by preventing misuse of the information in the courtroom, says Janet M. Corrigan, director of the IOM’s Quality of Health Care in America Committee, which released the report.

Perhaps the most controversial of the report’s recommendations is the call for a mandatory reporting system for serious errors whose data would be made public. Corrigan notes that those kinds of errors represent a narrow subset of all medical errors and, having caused death or serious patient injury, would be the ones most likely to draw lawsuits anyway.

It was because of concerns over increased medical malpractice liability exposure that the committee adopted a two-pronged approach to error reporting systems, the second being voluntary and for less serious errors, with legal protections against public disclosure, Corrigan adds. Further, the committee did not specify what type of data, whether aggregate or institution-specific, should be made publicly available from the mandatory reporting system, but Corrigan notes that the committee did not intend the data to be specific to individual health care practitioners "because we know that only a very small fraction of medical errors are attributable to an incompetent or irresponsible provider," the vast majority being attributable to systemic issues. "Blaming or levying sanctions on an individual provider is not the solution to this problem," she declares.

Openness with patients about medical mistakes may actually reduce the cost of malpractice liability, believes Arthur Levin, a member of the committee that drafted the IOM report and director of the Center for Medical Consumers. He cites a study published recently in the Annals of Internal Medicine of a veterans hospital in Kentucky demonstrating that full disclosure to patients who are injured accidentally or through medical negligence can reduce the number of malpractice suits against hospitals.

Levin notes that patients want more openness and disclosure from their physicians about the risks and benefits of alternative treatments, as well as success and failure rates. He encourages physicians to direct patients to a wealth of medical information sites available on the Internet to help them inculcate an informed and responsible set of expectations to bring to office visits. Levin believes that greater trust and transparency in the physician-patient relationship is the single greatest leverage to behavioral change leading to better quality and error reduction, reducing the current climate of suspicion and giving physicians greater incentive to identify and change behaviors that may drive malpractice liability up and patients away.

Health care institutions should also ultimately reduce their malpractice liability by adopting more systematic approaches to patient care like using automated drug ordering technology to reduce medication errors, suggests Corrigan.

"The clear message here is that we would really benefit from more standardization of various processes, and in many cases we need to design those processes so that it’s much more difficult for a provider to make an error," says Corrigan.

That approach raises questions about physician autonomy and authority, inasmuch as it puts a high priority on using clinical practice guidelines to reduce variation in health care delivery and outcomes, and encourages greater use of shared decision-making among physician and nonphysician providers in multidisciplinary teams.

As for physicians who resist using practice guidelines or who feel threatened by multidisciplinary teams, "I think they’re dead in the water. I think they’re obsolete," says David M. Lawrence, M.D., Chairman and CEO of Kaiser Foundation Health Plan, Inc., and a member of the IOM’s report committee.

Physicians’ judgments are constantly being questioned under any organizational model, and their autonomy is potentially threatened each time they refer a patient to a specialist who might have a different clinical point of view, Lawrence says. Physician autonomy is an outmoded notion that exists only in isolated settings serving an isolated population without referring many patients to other physicians, Lawrence adds.

Although he acknowledges that 75 percent of physicians still practice alone or in small groups, Lawrence argues that the best approach to medical care requires a comprehensive team of professionals to correctly manage patients and information as they are handed off from one part of the health care system to another, something he says the current delivery system is not built to support. For example, he notes, successful management of pediatric asthma requires health educators to instruct the child’s family how to medicate the child and avoid behavior and allergens that can trigger asthma attacks, tools for effective self-management, nurses to handle emergency phone calls and long term home visits.

"You can’t remove the judgment about clinical decisions from the treating physician. But you can create a care setting of constant investigation by physicians and colleagues about what is working," says Lawrence.

Care delivery based on practice guidelines, he maintains, is a prerequisite to responsible medicine and ultimately strengthens physician authority to control medical decision-making, according to Lawrence. "It’s simply indefensible for a physician not to stay with what current evidence or knowledge suggests is the safest and most appropriate way of practicing," says Lawrence.

A network of 70 to 100 physicians who group together to adopt an evidence-based, best practices approach to caring for patients in given disease categories and agree on a process to continually upgrade their care standards "has enormous power vis-a-vis the managed care company" to preserve physicians’ autonomy and negotiate effectively regarding appropriate care decisions, Lawrence says, contrasting that approach with physicians who group together in the form of a union, which he regards as primarily motivated by economic interests.

Kaiser Permanente’s HMO puts that model into practice in most of its markets, particularly those with "mature, well-established physician groups," whereby no precertification is required, utilization management is carried out by the medical groups themselves and physicians and pharmacists build their own drug formulary, Lawrence declares.

The chief obstacle to that approach to care delivery, says Lawrence, is training and acculturation of physicians that promulgates a wrong-headed definition of autonomy.

As variation in quality and in clinical practice patterns becomes more widely known and clearly understood by consumers, Lawrence says, reporting should shift consumer preference toward some physicians and health care systems and away from others.

Error reduction efforts in hospital systems will encourage a greater degree of interaction and discussion about practice patterns among departments and existing medical staffs, believes Molly Joel Coye, M.D., another member of the IOM’s committee and vice president and director of The Lewin Group’s San Francisco office. She notes that perhaps as much as 75 percent of medical errors are attributable to misrecording or incorrectly carrying out what a physician ordered, corrections of which would be no threat to physician authority.

Finally, an error reduction movement ought to encourage cultural change in health care organizations at the trustee and CEO level, spurring greater commitment to quality enhancement, e.g., creating high level committees to devise and implement new safety procedures, maintaining staffing levels of nurses and other health professionals that match patient needs and disseminating findings to other institutions, says IOM committee member Mary Wakefield, Ph.D., RN, director of George Mason University’s Center for Health Policy, Research and Ethics. She believes that the IOM report makes a convincing case to hospitals and health systems that the cost of implementing safety-enhancing systemic changes will be far surpassed by savings accrued from reduced length of patient stay and additional treatment costs.

Current Initiatives

What influence the IOM committee’s recommendations will have is an open question. Federal health officials appointed by President Clinton to evaluate the IOM committee’s proposals rejected a national mandatory reporting system in late January, saying that such reporting might yield less information than a well-designed voluntary reporting system and could result in unintended negative consequences. Clinton was expected to announce new patient safety initiatives in early February.

Legislation to reduce errors in Medicare, Medicaid and health care programs for the military, veterans and federal employees is being drafted by a bipartisan group of six senators led by Senator Joseph I. Lieberman (D-CT), and could require hospitals to report errors as a condition of Medicare and Medicaid participation, according to the Philadelphia Inquirer. The legislation could be modeled after the Department of Veterans Affairs patient safety program, which requires VA facilities to report errors and their causes, if available, to regional VA offices, which send the information to Washington but do not make the information public. The VA has also switched to an electronic medical records system and uses a bar coding system to prevent errors in drug dispensing and blood transfusion.

Other initiatives spawned by the IOM report include an announcement by the Joint Commission on Accreditation of Healthcare Organizations that it will begin making random, unannounced hospital inspections for the first time, an announcement by Aetna U.S. Healthcare that its quality measurement affiliate will share reports with participating hospitals to improve their clinical performance and reduce avoidable medical errors, and a $1 million grant from the Aetna Quality Care Research Fund to fund original research to develop strategies to reduce medical errors.

Whereas hospitals in southeastern Pa. appear to have a lukewarm reaction to the IOM report, several hospitals in western Pennsylvania have been proactively collaborating toward quality improvement months in advance of the report’s release. Hospital CEOs and senior clinical leadership, together with health care purchasers and insurers, have signed on to the Working Together Consortium, whose goal is to preserve quality of care in an environment of cost and budget cuts by using evidence-based medicine to drive utilization patterns and develop a benchmark for the best clinical outcomes for the region and the nation, says the consortium’s staff director Ken Segel.

The consortium’s membership also includes the Allegheny County Medical Society; leadership from Highmark Blue Cross Blue Shield, UPMC Health Plan, Aetna U.S. Healthcare, Health America; SMC Business Councils; Three Rivers Heinz Public Employees Purchasing Group; Pittsburgh Technology Council; and employee benefits managers and business and labor leaders from various companies including Mellon Bank, U.S. Steel, and the Steelworkers Union. Alcoa’s Chairman Paul O’Neil co-chairs the Working Together Consortium with Karen Feinstein, head of the Jewish Healthcare Foundation of Pittsburgh.

The consortium has a private contract with the Pennsylvania Health Care Cost Containment Council to use clinical outcomes data already collected and, in consultation with the consortium’s clinical specialists and purchasers, structure it into annual user-friendly reports that are shielded from public scrutiny, according to Segel. Reports have already been completed on total hip and knee replacement and on repeat C-sections, with future reports planned for invasive cardiac procedures, inpatient psychiatric care and inpatient diabetes, says Segel.

The consortium is meeting with individual hospitals in the six-county region to induce them to develop and implement changes to reduce outcome variations and encourage them to share the data and strategies for change with other institutions. The effort provides physicians with an enhanced leadership opportunity to begin to bargain away cruder cost control approaches, such as layers of bureaucracy and decision-making by nonphysician staff, says Segel.

More specifically focused on patient safety is the consortium’s second and more ambitious project: to secure commitment from the region’s hospitals to eliminate medication errors and hospital-acquired infections by agreeing to a number of collaborative activities:

• Share a common database.

• Share information about challenges and successes.

• Benchmark against national exemplar hospitals.

• Agree to random chart audits by an expert third party.

• Receive public recognition for excellent performance.

So far, a charter agreement to these activities has been signed by University of Pittsburgh Medical Center CEO Jeffrey Romoff, West Penn Allegheny CEO Charles O’Brien and Mon Valley Hospital CEO Anthony Lombardi, says Segel, who hopes to secure a total of eight to ten signatures.

The consortium has had preliminary meetings with its health insurance company members, who are interested in making their operations run more efficiently and cost-effectively. Segel notes that he has not encountered great opposition from the insurers to possible changes such as relaxing some utilization management practices and agreeing to uniform data collection.

The corporate and business group members, as payors of health care, have a vested interest in seeing the consortium’s projects to fruition, Segel says. They also have a sense, as leaders of complex organizations, of what paths to quality improvement to pursue and to avoid, he adds.

The nonprofit consortium is funded by the Jewish Healthcare Foundation of Pittsburgh, but also hopes to attract national private and federal grants for its activities.

On a national level, a group of health care clinicians, health product manufacturers, researchers, attorneys, consumer advocates, regulators and policy makers make up the board of directors of the National Patient Safety Foundation (NPSF), a nonprofit organization founded in 1997 by the American Medical Association, CNA HealthPro and 3M, notes Louis Diamond, M.D., chair of the foundation’s Applications and Learning Program.

The NSPF held a meeting of 50 major stakeholders of pharmaceutical safety last June to develop a consensus of the nature of the problem and released a report in August outlining a national agenda for improving pharmaceutical safety, says Diamond. The foundation now has a national steering committee, chaired by Diamond, to facilitate implementation of that agenda.

The foundation plans to hold a meeting this spring to identify how various stakeholders are responding to the IOM report on medical errors and to outline their preferences for implementation.

This October, the NPSF is sponsoring a meeting in Chicago showcasing existing safety solutions in any sector of the health care delivery system, at which a series of national awards will be given.

The NPSF is also creating an inventory of all public and private sector funding of research on patient safety and plans to hold a research summit on the matter later this year or early next year, Diamond notes.

Another independent, nonprofit agency, the Institute for Safe Medication Practices, was formed in the early 1990s to review medication errors that have been voluntarily submitted by practitioners to a national Medication Errors Reporting Program operated by United States Pharmacopeia and to share the information with the FDA and pharmaceutical companies whose products are mentioned in reports, according to the institute’s president, Michael Cohen. Over 1000 reports are submitted voluntarily each year, and the database does not include practitioners’ names so as to maintain altruistic motives for reporting and avoid a punitive dimension, he notes.

As a result of the database, says Cohen, hospitals have changed protocols, and drug companies have altered labels and taken products off the market.

Using resources from the institute, the American Hospital Association (AHA) is distributing to its 5000 member institutions a safe practices list and is developing a survey of hospitals’ progress on medication error prevention, says Don Nielsen, M.D., AHA’s senior vice president of quality leadership. Although implementation of the safe practice guidelines will be voluntary, Nielsen says the AHA expects that individual hospitals will want to put into place protocols such as instructing nurses not to accept orders that are not clearly written, listing standardized abbreviations with which physicians will be expected to comply, storing medications in the pharmacy rather than on the ward and following protocols for how information is to be given to patients during hospitalization and upon discharge.

Perhaps the greatest success story in medical error reduction is evident in anesthesiology, a specialty which has seen its patient death rate decline from about one in 10,000 in the early 1980s to about one in 200,000 today, according to Ellison C. Pierce, Jr., M.D., executive director of the Anesthesia Patient Safety Foundation. Whereas anesthesiologists paid about $30,000 for malpractice insurance 15 to 20 years ago, they now pay between $5000 and $10,000, indicating that the specialty has become much safer, says Pierce.

Safer technological devices and better anesthesia drugs have contributed a great deal to the improvement, says Pierce, while training in anesthesia residency programs and in nursing schools of anesthesia is also much better than it was and studies of mishaps and morbidity and mortality in a given hospital are much better.

For 15 years the foundation has been awarding starter grants in anesthesia safety research each year, and Pierce notes that there are now well above 100 papers on anesthesia safety at the annual scientific meeting of the American Society of Anesthesiologists, up from virtually none 15 years ago.

The foundation also distributes copies of a quarterly newsletter to every practitioner of anesthesia in this country and many abroad, including anesthesiologists, nurse anesthetists and residents, disseminating the latest safety research, Pierce adds.

A research project at the University of Texas at Austin is applying research about the causes of accidents in aviation to a study of human factors contributing to errors in the operating room. Led by Robert Helmreich, Ph.D., the research focuses on issues of team coordination and communication, leadership and decision making by collecting baseline data on the attitudes of personnel in an operating room, including surgeons, anesthesiologists, surgical nurses and nurse anesthetists.

In the midst of various initiatives to reduce medical error in inpatient settings, the Medical Group Management Association (MGMA) is conducting educational programs to improve patient safety in ambulatory care and group practice settings. Asked in an informal survey of MGMA members what was the leading risk to patient safety in their offices, over half identified lost laboratory or clinical data and 30 percent identified adverse drug interactions, according to MGMA President and CEO William F. Jessee, M.D.

MGMA will address outpatient safety issues with its members at a health policy conference scheduled this month in Washington, D.C. The organization is also planning to conduct a national research conference in late spring or early summer to define a research agenda and work toward implementation of the agenda with the Agency for Healthcare Research and Quality, says Jessee.