Clinton-Gore Administration Announces New Actions to Improve Patient Safety

Clinton-Gore Administration Announces New Actions to Improve Patient Safety

THE WHITE HOUSE
Office of the Press Secretary

For Immediate Release

February 22, 2000

CLINTON-GORE ADMINISTRATION ANNOUNCES NEW ACTIONS TO IMPROVE PATIENT SAFETY AND ASSURE HEALTH CARE QUALITY
Goal to Reduce Preventable Medical Errors By 50 Percent Within Five Years
February 22, 2000

President Clinton today will receive a new report on medical errors from the Administration’s Quality Interagency Coordination Task Force (QuIC) and unveil a series of landmark initiatives to boost patient safety. These initiatives will help create an environment and a system in which providers, consumers, and private and public purchasers work to achieve the goal set by the Institute of Medicine (IOM) to cut preventable medical errors by 50 percent over five years.

Developed in response to the President’s call for action in December, the QuIC response endorses virtually every IOM recommendation proposed and includes actions that go beyond it. Consistent with the QuIC recommendations, the President will call for: a new Center for Patient Safety; a requirement that each of the over 6,000 hospitals participating in Medicare to have in place error reduction programs; new actions to improve the safety of medications, blood products, and medical devices; a mandatory reporting system in the 500 military hospitals and clinics serving over 8 million patients; and a phased-in nationwide state-based system of mandatory and voluntary error reporting. The President will also commend the Vice President for his leadership on this issue, thank members of Congress in both parties for their work, and praise the efforts of consumers, doctors, hospitals, nurses, health plans and businesses to improve patient safety.

PREVENTABLE MEDICAL ERRORS: A NATIONAL CHALLENGE. Although the U.S. offers some of the best health care in the world, the number of medical errors is still too high.

Medical errors are common and costly. The IOM estimates that over half of adverse medical events are due to preventable medical errors, causing up to 98,000 deaths a year and costing as much as $29 billion annually. One study of over 30,000 patients indicated that nearly 60 percent of patients suffering adverse events in a hospital stay were subjected to a preventable medical error.

Medication errors account for a significant portion of preventable adverse events. The IOM estimates the number of lives lost to preventable medication errors account for over 7,000 deaths annually in hospitals alone and tens of thousands more in outpatient facilities nationwide. These errors increase hospital costs by an estimated $2 billion, and nursing homes costs by over $3 billion. A study of hospitals in New York State indicated that drug complications represent 19 percent of all adverse events, and that 45 percent of these adverse events were caused by medical errors. In this study, 30 percent of individuals with drug-related injuries died.

PRESIDENT UNVEILS NEW COMPREHENSIVE PLAN TO IMPROVE PATIENT SAFETY. Today, the President will announce the following new actions to assure patient safety:

A new Center for Quality Improvement and Patient Safety. Today, the President will announce that his FY 2001 budget includes $20 million, a 500 percent increase over last year’s funding level, to conduct research on medical errors reduction and create a new, IOM-recommended Center for Quality Improvement and Patient Safety. The Center will: fund research on patient safety; develop national goals for patient safety; issue an annual report on the state of patient safety; promote the translation of research findings into improved practices and policies; and educate the public.

The development of a regulation assuring that all hospitals participating in Medicare implement patient safety programs. This year, the Health Care Financing Administration will publish regulations requiring the over 6,000 hospitals participating in Medicare to have in place error reduction programs that include new systems to decrease medication errors. This action mirrors contractual requirements planned by the Federal Employees Health Benefits Plans and by many private sector purchasers. It also complements the voluntary efforts recently announced by the American Hospital Association.

The development of new standards to ensure that pharmaceuticals are packaged and marketed in a manner that promotes patient safety. Within one year, the Food and Drug Administration will develop new standards to help prevent medical errors caused by proprietary drug names and packaging that are easily confused with other those of other drugs. The agency will also develop new label standards that highlight common drug-drug interaction problems and other dosage errors related to medications. It will also implement a system that makes it possible to report serious adverse drug events on-line. The President is committing $33 million in the FY 2001 budget, a 65 percent increase over last year’s funding level, for medical error and adverse event reporting systems at FDA.

Modernized patient safety systems at the Department of Veterans Affairs and the Department of Defense to improve medication safety. The VA and DOD have been and continue to be leaders in the use of automated and other systems to reduce medical errors. The President will announce:

Full implementation of VA patient safety programs. This year, VA will complete implementation of an automated order entry system in all its health care facilities, along with a barcoding system for medication administration. These systems match patients with the medication they are supposed to receive. A 1999 pilot test indicates that they can reduce medication errors by up to 70 percent. In addition, the VA will increase patient safety training for staff from 15 to 20 hours a year and place "patient safety checklists" in operating rooms at every VA hospital.

Launch of new DOD patient safety programs. The DOD will launch an integrated pharmacy system for their over 8 million beneficiaries by the end of 2000. This new system will allow DOD physicians to accurately track prescriptions as they are filled in both public and private pharmacies worldwide. This fall, DOD will begin implementing a new computerized medical record that makes all relevant clinical information on a patient available when and where it is needed. It will be phased in at500 DOD hospitals and clinics over three years.

Comprehensive plans for a nationwide system of error reporting. Currently, 23 states (18 of which require hospital reporting) have reporting systems to track preventable medical errors and to help providers take corrective actions. Today the President will announce support for a nationwide system of error reporting -- one that will be state-based and phased in over time.

When fully implemented, this system will require mandatory reporting of preventable medical errors that cause serious injury or death, and will encourage voluntary reporting of other medical errors and "close calls." Information will be aggregated and made public (without identifying patients or individual health care professionals) to educate the public about the safety of their health systems. Both mandatory and voluntary reporting will enable providers to target widespread problems and develop the best preventive interventions. The Administration will take several actions to promote the importance of developing and using medical error reporting systems, including:

Launching new research to help implement mandatory reporting systems. The QuIC will ask the National Quality Forum to develop a set of patient safety measurements that can lay the foundation for a uniform system of medical errors data collection. HCFA will launch a pilot project in up to 100 hospitals to help them implement confidential mandatory reporting systems. HCFA will also work with hospitals in states that currently have mandatory reporting systems to identify and address issues associated with presenting medical errors data to the public.

Supporting expansion a"peer review protections" to encourage development of post-error review processes. Individuals or family members should have access to information about a preventable medical error causing serious injury or death. But analyses to determine the shortcomings of the hospital’s delivery system (root-cause analysis) and subsequent action to prevent such errors in the future should not be "discoverable information" used in litigation. That is why the Administration will support legislation that protects provider and patient confidentiality in order to encourage post-error review -- without undermining individual rights to redress for malpractice. Such legislation should be enacted in conjunction with, or prior to implementation of, nationwide mandatory and voluntary reporting systems.

Implementing a required reporting system at the Department of Defense. Beginning this spring, DOD will implement a new mandatory reporting system in its 500 hospitals and clinics, which serve approximately 8 million patients.

Expanding mandatory reporting requirements for all blood banks. By the end of the year, FDA will release regulations requiring the over 3,000 blood banks and establishments dealing with blood products to report serious errors affecting patient safety.

Implementing a voluntary reporting system nationwide for veterans’ hospitals. VA currently operates a mandatory reporting system. By the end of the year, VA will also implement a voluntary nationwide reporting system for adverse events and "close calls." Information will be collected by an independent entity and disseminated to all VA health care networks. Implementing this system is likely to lead to a richer database of information, as incidents are reported on a de-identified basis, and will allow researchers to compare the effectiveness of identified systems to de-identified ones.

Encouraging the development of voluntary systems and learning from existing systems. The Center for Quality Improvement and Patient Safety, with its Task Force partners, will evaluate current voluntary reporting systems at the federal and state levels and develop recommendations to improve them. This study will demonstrate which entity or entities would be best to collect, analyze, and disseminate information on frequently occurring errors and the best interventions to prevent them.

If all states have not implemented mandatory reporting systems within three years, the QuIC will deliver recommendations to the President that assure all health care institutions are reporting serious preventable adverse events. If research conducted by the Agency for Healthcare Research and Quality and other agencies indicates that the implementation of these systems does not enhance (or even detracts from) patient safety, the QuIC will modify its recommendations accordingly.

COMMENDS CONGRESS AND THE PRIVATE SECTOR FOR WORKING TO PROMOTE PATIENT SAFETY. Today, President Clinton noted the strong bipartisan interest in improving patient safety and that committees in the House and Senate held hearings to explore possible avenues to address this issue. The President noted that the Senate Appropriations and Health, Education, Labor, and Pensions (HELP) Committee will hold a joint hearing today, and have separately held several previously. He thanked the members of these Committees and other leaders in the Congress on this issue, including Senators Kennedy, Jeffords, Spector, Harkin, Dodd, Frist, Lieberman, Kerrey, Grassley, and several members of the House in both parties for their work. He also recognized and commended the ongoing work of the American Hospital Association, the American Medical Association, the American Nurses Association, and the Business Roundtable’s “Leapfrog Group”.

BUILDS ON THE CLINTON-GORE ADMINISTRATION’S LONGSTANDING COMMITMENT TO IMPROVING PATIENT SAFETY. In early 1997, the President established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry (Quality Commission) and appointed Health and Human Services Secretary Shalala and Labor Secretary Herman as co-chairs. The Quality Commission released two seminal reports on patient protections and quality improvement. Subsequent to the Commission’s second report on patient safety and quality improvement, and consistent with its recommendations, the President established the Quality Interagency Coordination Task Force (QuIC), an umbrella organization also co-chaired by Secretary Shalala and Secretary Herman, to coordinate Administration efforts to improve quality. Also consistent with the Quality Commission’s recommendations, Vice President Gore launched the National Forum for Health Care Quality Measurement and Reporting. The “Quality Forum” is a broad-based, widely-representative private advisory body that develops standard quality measurement tools to help purchasers, providers, and consumers better evaluate and ensure the delivery of health care services. In addition to the work and significant potential of the QuIC and Quality Forum, other Federal agencies have made significant efforts to reduce medical errors and increase attention on patient safety. Last December, at the President’s direction, the Office of Personnel Management announced it will require all plans participating in the federal health program to implement error reduction and patient safety techniques.