Issue Brief

October  2000

Patient Safety and Medical Errors Part I    

What is the Government's Role?
If you have ever taken care of an elderly parent, sick child, or chronically ill spouse, you know how easy it is to make a mistake. Did you remember to give that pill at breakfast? Did you read the directions correctly? Should you apply heat or cold to that pain? While these are often minor concerns, they occur frequently enough to give us some sympathy for the nurses and doctors who must wade through a complex array of new medicines and technology to care for us.

Having said that, I think most of us were quite shocked at the number and scope of the medical errors problem reported by the Institute of Medicine (IOM) in its November 1999 report entitled To Err Is Human: Building A Safer Health System. This report concluded that errors cause between 44,000 and 98,000 deaths in U.S. hospitals every year. Some have challenged this report as erroneous and claim it overstates the number of deaths caused by preventable errors. The IOM researchers defend their report and note that -- if anything -- the report understates the number of deaths.

From my perspective this debate misses the point. Whether there are 98,000 deaths or “only” 20,000, it is still too many. The critical value of the IOM report is that it has made us all think and talk about ways to improve patient safety within the healthcare – not just in hospitals, but also in nursing homes, doctors offices, pharmacies, and the home. This is a conversation that is long overdue.

What Steps are Needed to Improve Patient Safety?
The most important finding in the IOM report is that the vast majority of preventable errors are not due to flaws of incompetence or carelessness on the part of individual doctors, nurses, or other workers. People don’t want to make mistakes and they try hard not to. Rather the IOM estimates that the vast majority of errors – perhaps 95% to 98% -- are “system errors.”  That means that most mistakes are the direct result of procedures, equipment, job designs, communication systems, and other elements in the work environment.

In Congressional testimony, Dr. Donald Berwick, a member of the IOM’s Committee on the Quality of Health Care in America stated, “…only system changes can help. One implication of a systems view of error is that the responsibility for safety lies with the people who organize and run those systems – i.e. executives, clinical leaders, boards of trustees. It is they, not individual doctors and nurses, who can do the most to make patients safer.”

The IOM report also found that this is not an insurmountable problem. We can do something about safety. There is a great deal of research that has already been done on causes of errors and ways to prevent them in complex systems. Other industries such as aviation rely on this research and have made great strides in making their systems safer. The IOM believes that using this kind of knowledge can improve patient safety immediately, and if more work is done on systems unique to health care, errors can be reduced even further.  The IOM suggested a national goal of 50% reduction in patient injuries over the next five years. President Clinton has embraced that goal and has established a national action plan to achieve that goal.

There is one catch, however. Improving patient safety may require serious changes in the culture of healthcare. Systems thinking is not historically rooted in medicine. On the contrary, the field of medicine has typically ascribed errors to individuals and embraced the “name-blame-shame-and-train” approach to error reduction. This approach by its very nature forecloses the opportunity to find systems solutions to problems. And it breeds a culture of secrecy that further erodes safety.

Who are the Players Needed to Improve Patient Safety and Reduce Errors?
American health care has evolved into a complex system with many different players and they all need to be involved if we are to significantly improve patient safety. Healthcare providers, accreditation societies, professional societies, insurers, employers, researchers, and all levels of government must play a part.

Reducing medical errors will require sharing information. If we are to learn from mistakes, we need to know about them. Under today’s system healthcare workers are punished – or fear they will be punished -- for reporting errors. To build safer systems, workers need to be shielded from punishment for reporting mistakes and unsafe conditions. Under ideal conditions they would even be rewarded. This is what has happened in aviation and now the voluntary Aviation Safety Reporting System run by NASA for the FAA receives more than 30,000 reports a year from pilots, air traffic controllers and others. The people reporting these problems know they will not be punished and if there was no criminal activity involved, the act of reporting protects them from possible legal action. We still have aviation accidents, but aviation is significantly safer today than a few decades ago because we have disclosure on its hazards.

The private sector has already begun to make major efforts to improve patient safety and there have been some significant successes. The field of anesthesiology has been working on improving its safety record for fifty years and has made dramatic improvements -- from 1death in every 3,000 to 4,000 patients in the 1950’s to 1 death for every 200,000 to 300,000 by 1990. The Anesthesia Patient Safety Foundation attributes this success to the field’s early identification of safety problems, its promotion of research and sharing of information, and its emphasis on patient safety in clinical practice.

Another organization that has done substantial work in safety recently is the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO). In 1997 the JCAHO began to issue periodic Sentinel Event Alerts to share information about known risky behaviors and best practices gleaned from its database of error-related information. Although they are not able to put a number on it, they believe their Alerts have saved lives. They know, however, that they could do much more if the government would provide protection from litigation for the people who share information on serious medical errors.

Many other initiatives exist in the private sector to improve patient safety, and most will require changes in law and public policy if they are to realize their full potential.

What Can Governments Do?
The federal government has several roles to play in promoting patient safety. It is the largest purchaser and provider of health care in the U.S. It provides billions of dollars in support for health care research each year and it oversees employer-based health care coverage. In order to promote greater safety for patients the federal government needs to:

 1.  Do Research and Set Standards
The federal government is in a unique position to fund the research necessary to develop a standard set of safety measures and a reporting mechanism to help health systems improve patient safety. The Quality Interagency Coordination Task Force (QuIC) within the Agency for Healthcare Research and Quality (AHRQ) is currently working very hard on this effort. One of the challenges is deciding what information needs to be gathered and analyzed nationally and what is more appropriately handled at the state or facility level.

The President requested $20 million in his budget for a Center for Quality Improvement in Patient Safety and the Senate Appropriations Committee recently earmarked $50 million for the AHRQ to “develop guidance on the collection of uniform data related to patient safety.” These actions are a direct response to the IOM report.

2. Provide Information
In 2000 Congressman Tom Bliley, Chairman of the House Commerce Committee introduced a bill to open the National Practitioner Data Bank (NPDB) to the public. The NPDP contains disciplinary and medical malpractice payment information about doctors and other health care practitioners. Opponents of this proposal argue that the data bank never was intended for public access, and information in it is so raw that it could be deceptive and harmful to both consumers and doctors. Proponents point to states such as Massachusetts, the first state to make this type of information available to the public. In 1996 Massachusetts created a Physician Profiles Program to help patients find the right doctors. It is not designed to educate the public not discipline doctors. It does, however, include malpractice information, disciplinary actions, hospital discipline, and criminal history along with educational background and other information on doctors who practice in that state. The Physician Profiles Program was developed by the Massachusetts Board of Registration in partnership with the state medical society, the legislature, and the governor. Finding the right balance between appropriate and useful information for consumers and protecting physicians from unwarranted adverse information is difficult but in Massachusetts they think they have done it. Time will tell if Congress can find the right balance on a national level.

The government also can provide the public with better general information. In direct response to the special concerns highlighted by the IOM report, AHRQ has recently posted on its web site a patient fact sheet entitled “20 Tips to Help Prevent Medical Errors.”

3.  Legislate and Regulate 
a.       The IOM recommends widespread use of blame-free reporting systems in healthcare organizations. They asked Congress to pass legislation to extend peer review protection to data related to patient safety that are used solely for improving safety. This recommendation will require changes in state law as well as federal law and needs to be seriously debated in policy processes at both levels.

b. The IOM recommended that a national mandatory reporting system be established for the collection of standardized information about adverse events that result in death or serious harm to patients. Again decisions about what types of reporting should be mandatory and what should be voluntary need to be debated in the public policy arena.  In case of mandatory systems, some enforcement mechanism needs to be established to ensure that requirements are met.

c. The President has asked the Food and Drug Administration (FDA) to develop new standards for preventing errors caused by look-alike, sound-alike drugs. In addition the FDA will develop new label standards that highlight common drug interactions and dosage errors.

4.  Innovate and Implement 
Perhaps the most important thing the government can do is lead by example. The federal government, through its Veterans Administration health system, Department of Defense facilities, and programs like Medicare and Medicaid, is the largest provider of health care services in the country. If it can significantly improve patient safety in its programs, it can provide a model that will help health care providers throughout the nation. In Part 2 of this Issue Brief we will discuss in detail some of the federal government’s efforts to create a culture of safety in its own facilities.