An Ounce of Prevention

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Patient Safety Legislation

by Robin Diamond, JD, RN; AHA Fellow–Patient Safety Leadership; Vice President, Patient Safety

Since the Institute of Medicine (IOM) published “To Err Is Human” in 1999, there has been much discussion about medical error and what can be done to reduce the number of errors that occur in the health care industry in order to improve the quality and safety of patient care. Even though a consensus does not exist as to the number of deaths caused by medical errors, everyone agrees that it is too many.  

Basic human factors theory teaches us that humans make mistakes—that it is our right—and that many errors are unavoidable. However, if we do a good enough job in designing a process or system, and if we learn to work as a team and communicate effectively, the number of errors can be reduced.

One of the strategies that the health care industry has learned from the aviation and nuclear power industries is that when an error occurs—or almost occurs—everyone must be expected to report the error so that an analysis can be done, processes revised, and fail-safe modes established, thereby minimizing the possibility of its occurring again. 

Easier said than done! The tension between the legal reality of lawsuits and the open discussion of the error or resulting patient injury is very strong and unyielding. In order to learn from mistakes, the health care industry must be able to establish a system for reporting errors to a central location where they can be analyzed and the resulting information can be disseminated throughout the industry.

The Patient Safety and Quality Improvement Act of 2005

The 1999 IOM report recommended that Congress pass legislation to protect the analysis of information related to improving the safety and quality of patient care.  

The Patient Safety and Quality Improvement Act of 2005, signed into law by President Bush in July 2005, codifies some of the IOM’s recommendations and is supported by such groups as the American Medical Association, the American Hospital Association, and the American College of Surgeons.  

The following summarizes some of the major provisions of the legislation: Physicians, hospitals, and other health care professionals can voluntarily and confidentially report information related to errors to a Patient Safety Organization (PSO). PSOs must be established and sanctioned under the guidelines of this law and certified by the Department of Health and Human Services (HHS). The HHS, through the Agency for Healthcare Research and Quality (AHRQ), will analyze the data and maintain a network of patient safety databases accessible by health care providers. These databases should identify and support standards of care that will promote safety.

Information that meets the definition of “patient safety work product” is precluded from being used against providers in civil and administrative proceedings. Because of the protection this legislation renders to patient safety information, proponents believe it will support the creation of a health care culture that exposes and addresses systemic causes of errors.

Others believe that this legislation does not accomplish nearly enough—that, for example, the legislation should mandate the reporting of certain types of errors and the resulting injury.

Another possible drawback to this legislation is the fact that until the PSOs are established and certified, patient safety information reporting cannot move forward. An additional complication is that 23 states have reporting requirements, and most are mandatory. Will some of these state systems become PSOs? If not, will providers have to report to several different bodies?

The Medical Error Disclosure and Compensation Act (MEDiC)

On September 28, 2005, Senators Hillary Rodham Clinton and Barack Obama introduced the Medical Error Disclosure and Compensation Act, also known as the National MEDiC Act.

This legislation, modeled on the “Sorry Works” program in Illinois, creates a voluntary federal program—an alternative to lawsuits—to assist providers in negotiating compensation with patients who have been harmed by errors.

Specifically, the MEDiC Act creates an Office of Patient Safety and Health Care Quality within the HHS to administer the program. The director is tasked with adopting a standard patient safety taxonomy and with developing a process by which data will be entered into an electronic warehouse, where the information cannot be identified by patient, provider, or reporter.

The intent of the MEDiC program is to 1) encourage open communication between patients and their health care providers; 2) reduce medical error rates; 3) ensure that patients are compensated for injury, negligence, or malpractice without initiating a lawsuit; and 4) reduce the cost of medical liability insurance.

Another section of the MEDiC Act, called the MEDiC Grant Program, allows eligible participants to apply for funding to develop and implement communication training programs and to improve the use of information technology. 

Still another section calls for an analysis of the medical liability insurance market— which, among other things, will look at tort reform on a state-by-state basis to determine whether it has resulted in a decrease in, or at least a stabilization of, the cost of medical liability insurance premiums.

Even though the Clinton/Obama bill builds on the Patient Safety and Quality Improvement Act of 2005, there are potential areas of overlap, such as reporting structures, the creation of additional HHS offices, and the establishment of patient safety databases that will have to be evaluated and coordinated.

The free exchange of communication between health care providers and their patients enhances the safe delivery of care—from the patient-physician relationship to physicians sharing safe practices with other physicians that, when utilized, will potentially decrease the likelihood of the same errors occurring over and over. Protecting patient quality and safety information from legal discovery is one step toward a health care culture of transparency.

Stay tuned for more information both on our Web site at www.thedoctors.com and in The Doctor’s Advocate as the Patient Safety and Quality Improvement Act of 2005 and the Medical Error Disclosure and Compensation Act become reality.

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