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Summer 2004

Dr. Gluck

The Patient Safety and Quality Improvement Act

Professional liability reform and patient safety improvement are two sides of the same coin. With the former, we are trying to reduce economic losses and stabilize professional liability insurance premiums with measures such as caps on noneconomic damages, limitations on contingency fees, and collateral source offsets. With the latter, we are striving to decrease hazards and design safety nets resulting in fewer patient injuries and thereby fewer compensable events.

In past columns, I have discussed the professional liability crisis and reform. In other columns, I have discussed patient safety. Now I would like to discuss important Federal legislation, which brings them both together in a bill that will significantly improve patient care – "Patient Safety and Quality Improvement Act" (HR 663, SB 720). This legislation, co-sponsored by Florida Representative Mile Bilirakis, would create a confidential, voluntary reporting system for medical errors and near misses, provide grants to assist healthcare organizations purchase computer physician order entry systems, and establish a Medical Information Technology Advisory Board. It would also mandate bar coding on all prescription medication. Patient Safety Organizations would be established to collect, de-identify, and analyze these reports and then suggest system changes that would measurably improve patient safety.

This bill is modeled after Aviation Safety Reporting System (ASRS), in which confidential reports are analyzed by the National Aeronautics and Space Administration. There are no repercussions, even if the person reporting was the one who caused the problem. The elements of blame, shame, and punishment have been eliminated. The ASRS along with a culture of safety have made commercial aviation, a highly complex and potentially hazardous environment, one of the safest of all human activities.

HR 663 was passed by the House of Representatives in March 2003 by an overwhelming margin with over 400 yea votes. SB 720 has bipartisan support from Senator Bill First, MD (R, Tennessee) and Senator John Breaux (D, Louisiana). It was unanimously (20-0) passed out of Senate Health, Labor and Pensions Committee in July 2003. This bill also has enthusiastic support from President Bush, yet when it was brought to the Senate floor in April 2004 for unanimous consent, Minority Whip Senator Harry Reid (D, Nevada) objected because the Democrats needed more time to "study" the bill.

Where is the problem? The trial lawyers are concerned that if all these medical "incidents" are kept confidential they will not successfully litigate as many cases. How hypocritical from a group whose public mantra has always been that they are the patients’ watchdog to root out errors, punish bad doctors and improve patient safety. Indeed the Harvard Medical Practice Study, one of the cornerstones of the IOM report To Err is Human (1999), has shown that there is no correlation between medical error and malpractice litigation. Most lawsuits are because of patient injury, not substandard care.

The most effective way to improve patient safety is to create an atmosphere of trust. We must move from a culture of "name, blame, shame and retribution" to a culture of safety. We must realize that in general healthcare providers are dedicated, talented and hardworking individuals who toil everyday in a flawed system to do their best for each and every patient. Safety science is striving to promote system changes to reduce medical errors and measurably improve patient safety. A critical first step is establishing the Patient Safety Reporting System. Contact Senators Bob Graham (D, FL) and Bill Nelson (D, FL). We need this bill for us, for our profession, and most importantly, for our patients!