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Date:01/25/2000
Session:106th Congress (Second Session)
Witness(es):Molly Joel Coye
Credentials:  Vice President and Director, West Coast Office, The Lewin Group, San Francisco, Calif.; and Member, Committee on Quality of Health Care in America, Institute of Medicine, The National Academies
Chamber:Senate
Committee:Labor, Health and Human Services, Education and Related Agencies Subcommittee, Committee on Appropriations, U.S. Senate
Subject:Patient Safety at Veterans’ Facilities

Statement of

Molly Joel Coye, M.D.
Vice President and Director, West Coast Office
The Lewin Group, San Francisco, Calif.
and
Member, Committee on Quality of Health Care in America
Institute of Medicine
The National Academies

Concerning Patient Safety and Medical Errors

Before the

Subcommittee on Labor, Health and Human Services, Education and Related Agencies
Committee on Appropriations
U.S. Senate

January 25, 2000

Good morning, Mr. Chairman and Senator Harkin, and members of the Committee. My name is Molly Joel Coye and I am Senior Vice President of The Lewin Group. I am here today representing the Institute of Medicine’s Committee on the Quality of Health Care in America which recently released the report To Err is Human: Building a Safer Health System.

I realize that this is the second in a series of hearings that the Subcommittee is holding on the issue of patient safety, and that testimony on the IOM recommendations has already been provided by my colleague, Mary Wakefield. For this reason, I will only briefly review the IOM Committee’s recommended strategy for improving patient safety, and will focus most of my remarks on addressing some of the frequently asked questions regarding the Committee’s recommendations.

Let me first say that the IOM Committee on the Quality of Health Care in America concluded that medical mistakes ranks eighth among the leading causes of death--ahead of traffic accidents, breast cancer, and AIDS. Furthermore, we strongly believe that it is possible to achieve at least a 50 percent reduction in errors over five years. The knowledge and technology exists to prevent many of these mistakes.

To address this serious issue, our report puts forth a comprehensive strategy for government, industry, consumers, and providers all to take action. The strategy calls for:

• The creation of a Center for Patient Safety within the Agency for Healthcare Research and Quality to provide leadership, invest in applied research on medical errors, build prototype systems to improve safety, and disseminate information on "best practices" throughout the health care system.

• Establishment of mandatory and voluntary reporting systems. A nationwide, state-based mandatory reporting system is needed to collect information on the most serious errors that result in death or permanent harm, and to use this information to better understand the factors that contribute to errors, to encourage health care organizations to take the necessary steps to prevent future events, and to keep the public informed of safety issues. The growth of voluntary reporting systems, focusing on errors that result in lesser or no harm, should be encouraged by extending peer review protections to data and information in these systems.

• Strengthening the standards and expectations for improvements in safety that are set by accrediting and licensing organizations, group purchasers, and professional groups.

• Creating safety systems inside health care organizations.

The response to the IOM report on errors has been phenomenal. The report received top-placement and near saturation coverage in the national media, including front page and leading news coverage in most of the major national newspapers, evening news and morning shows. There were also more than 100 live and taped appearances of Committee members on local television and radio stations. In a recent survey conducted by the Kaiser Family Foundation and Harvard School of Public Health, it was found that 51% of Americans closely followed news of the release of the report. Moreover, steady news coverage of this critical issue continues.

Since the release of the report, many questions have been raised regarding the recommendations pertaining to the creation of a Center for Patient Safety and the mandatory and voluntary reporting systems. I would like to share with you some of the Committee’s thinking in these two areas.

Meeting the patient safety challenge will require leadership and actions at all levels, but national leadership, attention and resources are absolutely critical to making safety the #1 priority of every health care institution. Experience from other industries, such as aviation, suggests that unless a Center is created to keep attention focused on patient safety and enhance the base of knowledge and tools, meaningful progress is not likely.

The Center for Patient Safety is not intended to be a regulatory or standard-setting body, but it is expected to track progress and issue an annual report to the President and Congress on patient safety, and to enhance knowledge of safety by funding research into the application of safety sciences to health care and the development of prototype systems. The Center would also be responsible for dissemination of information on "best practices."

The IOM Committee also believes there should be mandatory and voluntary reporting systems. Mandatory reporting systems should focus on detection of errors that result in serious patient harm or death. While safety experts recognize that errors resulting in serious harm are the "tip of the iceberg," they represent the small subset of errors that signal major system breakdowns with grave consequences for patients.

Mandatory systems serve three purposes. First, they provide the public with a minimal level of protection by assuring that the most serious errors are reported and investigated and appropriate follow up action taken. Second, they provide an incentive to health care organizations to improve patient safety in order to avoid the potential penalties and public exposure. Third, they require all health care organizations to make some level of investment in patient safety, thus creating a more level playing field.

The IOM Committee believes that the public has a right to be informed about unsafe conditions, and a right to expect health care organizations to respond to evidence of safety hazards by taking whatever steps are necessary to make it difficult or impossible for a similar event to occur in the future. As the report indicates, "Only the institution can redesign its systems for safety; the great majority of effort in improving safety should focus on safe systems, and the health care organization itself should be held responsible for safety."

It is recommended that a nationwide, state-based system of mandatory reporting be established that provides for the collection of standardized information about the most serious errors. Congress should provide funds and technical expertise for state governments to establish or adapt their current error reporting systems to collect the standardized information, analyze it and conduct follow-up action as needed with health care organizations.

Standardized reporting formats serve three purposes. First, consistent definitions and methods of data collection across organizations and geographic regions permits data to be aggregated and tracked over time. Second, a standardized format lessens the burden on health care organizations that operate in multiple states. Third, a standardized format facilitates communication with consumers and purchasers about patient safety.

Although state governments would be responsible for the mandatory reporting program, this does not mean that a state would have to collect and analyze the data themselves. A state may choose to rely on an accrediting body, a peer review organization or other private sector oversight entity to perform this function. Flexibility and innovation in implementation is important at this stage of development because states that have existing adverse event programs have used different approaches to implement their programs and a "best practice" or preferred approach is not yet known.

About twenty states currently have mandatory error reporting programs. Since the release of the IOM report, numerous other states are exploring the option. For example, the Maryland State legislature is holding hearings this week on the issue of patient safety and error reporting.

The IOM Committee believes that voluntary reporting systems play a valuable role in encouraging improvements in patient safety and are a complement to mandatory reporting systems. The focus of voluntary systems is usually on errors that resulted in no harm (sometimes referred to as "near misses") or very minimal patient harm. Voluntary reporting systems are particularly useful for identifying types of errors that occur too infrequently for an individual health care organization to readily detect based on their own data, and patterns of errors that point to systemic issues affecting all health care organizations. The continued development of voluntary reporting systems should be encouraged, and voluntary reporting systems should be afforded legal protections from data discoverability.

Thank you for this opportunity to testify. I would be happy to answer any questions the Committee may have.

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