Group of Senators Introduces Bill That Would Implement Patient Safety Protections

Sens. John Breaux (D-La.), Bill Frist (R-Tenn.), Judd Gregg (R-N.H.) and James Jeffords (I-Vt.) on June 5 introduced the Patient Safety and Quality Improvement Act, which would implement many recommendations suggested by the Institute of Medicine for the reporting of medical errors, CongressDaily/AM reports. In 1999, the IOM released a report stating that up to 98,000 Americans die each year from preventable medical mistakes, prompting members of Congress to consider legislation that would create systems to monitor, analyze and prevent such errors. The Breaux-Frist-Gregg-Jeffords bill would establish patient safety organizations to allow health workers to voluntarily and confidentially report medical mistakes. The organizations would analyze medical error data and make recommendations on medical mistake prevention. Previous efforts to pass medical error measures have "foundered," particularly because of disagreement on whether medical error reporting information should be available for use in lawsuits. Democrats such as Sen. Edward Kennedy (D-Mass.) have been "reluctant" to allow confidentiality for workers reporting errors in cases where a patient has serious injuries or dies because of a mistake. Under Breaux-Frist-Gregg-Jeffords, medical error information reported to the patient safety organizations would not be subject to criminal, civil or administrative subpoenas, nor would it be available through the Freedom of Information Act or legal discovery proceedings. Kennedy has not endorsed the measure, but a spokesperson for the senator said that Kennedy still is "hopeful" that an "acceptable" bill can be agreed upon. A similar bill is expected to be introduced in the House (Rovner, CongressDaily/AM, 6/6).

Methodology of IOM Report Questioned
In related news, a study published in the June 4 issue of the Annals of Internal Medicine calls into question the methodology of the 1999 IOM report, the New York Times reports. The IOM report has often been cited as justification for investment in computer physician order entry systems and other technologies to reduce medical errors. In the study, Dr. Eric J. Thomas and colleagues at the University of Texas-Houston Medical School asked physicians to review 500 medical records of hospitalized patients in Utah and Colorado in 1992 to measure the "accuracy of chart review" in the determination of adverse medical events. The study found that doctors "could be wrong almost a third of the time, depending on what rules they used" (Nagourney, New York Times, 6/4). For example, the study found that the number of reported medical errors dropped when researchers increased the number of reviewers from one to three and required reviewers to be "highly confident" that an adverse medical event resulted from negligence. As a result, the study concluded that the number of annual deaths attributed to medical errors in the United States could range from 50% fewer to 30% more than the number in the IOM report, which researchers based on a review of patient medical records (Thomas et al., Annals of Internal Medicine, 6/4).