Adam J. Falk, JD, MPH, Feldesman Tucker Leifer Fidell LLP, 2001 L St., N.W., Suite 200, Washington, DC 20036, (202) 466-8960, afalk@feldesmantucker.com

In 1999, the Institute of Medicine (IOM) concluded in its landmark report To Err is Human: Building a Safer Health System that medical errors— errors caused by medical management rather than a patient’s underlying condition— are the eighth leading cause of death in the United States, accounting for up to 98,000 deaths annually. To address the problem, the House of Representatives passed H.R. 663, the Patient Safety and Quality Improvement Act, on March 12, 2003, creating a voluntary system for reporting of medical errors. The Senate’s Health, Education, Labor and Pensions (HELP) Committee unanimously approved similar legislation, S. 720, the Patient Safety and Quality Improvement Act, on July 23, 2003, and the bill is awaiting floor action. Both versions of the legislation create “patient safety organizations” that would collect information on medical errors, analyze it, and report on ways to prevent similar errors from occurring. To encourage voluntary reporting, the legislation deems medical error reports privileged and confidential. Some have expressed concern that the privilege and confidentiality provisions would preempt existing state mandatory reporting laws, shielding from public view information now available about health care providers. Applying the federal legislation to a hypothetical “conflict” situation, I conclude that compliance with both state reporting laws and the proposed federal law would be possible, and that therefore preemption is unlikely.

Learning Objectives:

• Structure of federal patient safety legislation's voluntary reporting system
• Impact of federal reporting system on states with mandatory reporting laws

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.