Building Careers and Shaping Public Policy

June 24, 2005

The Honorable Bill Frist, MD
Majority Leader
United States Senate
Washington, DC 20510

Dear Senator Frist:

The IEEE-USA applauds the Association of American Medical Colleges and 125 other healthcare organizations and joins them in respectfully urging Congress to pass a patient safety bill that will improve and protect the safety of America’s patients. We encourage Congress and the President to provide strong national leadership, with bipartisan support that puts America’s patients first, to promote patient safety.

To achieve this end, we support the enclosed "General Principles for Patient Safety Reporting Systems" advanced by AAMC’s Patient Safety Working Group. In addition, we strongly recommend the creation of national standards for definitions related to medical errors and the data fields used for reporting the information. Currently, at the State level, information interchange is limited by the lack of these standards. Once standards have been established then advanced information technologies can be utilized to achieve maximum information to promote best practices.

The Institute of Medicine’s 2004 report on "Patient Safety: Achieving a New Standard of Care" also highlighted that errors of omission are far more frequent than errors of commission. We therefore encourage the leadership to draft legislation that would strengthen the focus on errors of omission and develop mechanisms for intervention and education to quickly disseminate demonstrated best practices.

IEEE-USA is an organizational unit of the IEEE. It was created in 1973 to advance the public good and promote the careers and public policy interests of the more than 220,000 technology professionals who are U.S. members of the IEEE. The IEEE is the world's largest technical professional society. For more information, go to http://www.ieeeusa.org. If we can be of further assistance, please contact Deborah Rudolph in our Washington office at (202) 785-0017 x 8332 or email at d.rudolph@ieee.org.

Sincerely,

Gerard A. Alphonse
President, IEEE-USA
 

General Principles for Patient Safety Reporting Systems

Creating an Environment for Safety. There should be a non-punitive culture for reporting healthcare errors that focuses on preventing and correcting systems failures and not on individual or organization culpability.

Healthcare professionals and organizations should foster a positive atmosphere that encourages the submission of healthcare error reports to public or private oversight organizations, accrediting bodies, an official compendial body, or other generally recognized patient safety reporting systems. The existence of a reporting system does not relieve healthcare professionals and organizations of their responsibility to maintain professionally recognized standards of care.

Data Analysis. Information submitted to reporting systems must be comprehensively analyzed to identify actions that would minimize the risk that reported events recur.

Systems within organizations should be scrutinized to identify actions to prevent future errors. Effective procedures and/or protocols developed through reporting systems should be compiled and widely disseminated to all healthcare professionals and organizations.

Confidentiality. Confidentiality protections for patients, healthcare professionals, and healthcare organizations are essential to the ability of any reporting system to learn about errors and effect their reductions.

Reporting systems should protect the identity of individual patients and abide by all relevant confidentiality laws and regulations. The identities of healthcare professionals and organizations involved in errors should not be disclosed outside a reporting system without consent.

Information Sharing. Reporting systems should facilitate the sharing of patient safety information among healthcare organizations and foster confidential collaboration with other healthcare reporting systems.

Sharing information is fundamental to a reporting system's ability to achieve widespread improvements in patient safety and to instill a confidence in the public that safety issues are being addressed. Sharing of error-related information is subject to the confidentiality principle.

The causes of errors and their solutions must be widely shared so that all healthcare organizations can learn from the experiences of others.

In some circumstances, it will be desirable to share reports of errors among reporting systems, and with other appropriate quality improvement entities, in order to accomplish root cause analyses, to construct action plans, and to engage in other efforts to enhance patient safety.

Legal Status of Reporting System Information. The absence of federal protection for information submitted to patient safety reporting systems discourages the use of such systems, which reduces the opportunity to identify trends and implement corrective measures. Information developed in connection with reporting systems should be privileged for purposes of federal and state judicial proceedings in civil matters, and for purposes of federal and state administrative proceedings, including with respect to discovery, subpoenas, testimony, or any other form of disclosure.

Scope. The privilege for the information prepared for a reporting system should extend to any data, report, memorandum, analysis, statement, or other communication developed for the purposes of the system. This privilege should not interfere with the disclosure of information that is otherwise available, including the right of individuals to access their own medical records.

No Waiver. The submission of healthcare error information to a reporting system, or the sharing of information by healthcare organizations or reporting systems with third parties in accordance with these principles, should not be construed as waiving this privilege or any other privilege under federal or state law that exists with respect to the information.

Freedom of Information Act. Healthcare error information received by and from reporting systems should be exempt from the Freedom of Information Act and other similar state laws. Such an exemption is necessary to preserve the privilege discussed in this principle.

Impact on State Law. A federal law is necessary to assure protection of information submitted to national reporting systems, but the federal protection should not preempt state evidentiary laws that provide greater protection than federal law. Providing such information to reporting systems should not constitute a waiver of any state law privilege.