New Patient Safety Law Boosts Medical Error Prevention
Legislative Affairs Feature - October 2005
By Ken Ortolon
A stinging 1999 Institute of Medicine (IOM) report that concluded medical errors killed 98,000 patients annually gave physicians a lot to think about. But many physicians and other health care professionals complained that finger-pointing and the fear of being sued caused many people to keep their mouths shut and not share information that could help root out problems in the health care delivery system.
Thanks to a law President George W. Bush signed on July 29, the blame game may be over. The Patient Safety and Quality Improvement Act of 2005, authored by Sen. Jim Jeffords (I-Vt.), creates a voluntary and confidential system for reporting medical errors to help develop solutions that can prevent errors from being repeated.
The legislation passed with strong support from physicians, hospitals, and other health care organizations. American Medical Association President J. Edward Hill, MD, called it a victory for both patients and physicians.
"The health care community has long been committed to improving patient safety, and significant progress has been made through new technology, research, and education," Dr. Hill said. "This patient safety law is the catalyst we need to transform the current culture of blame and punishment into one of open communication and prevention."
While health professionals applauded the new reporting system, some cautioned that details yet to be worked out will determine how effective it will be.
The Patient Safety and Quality Improvement Act ended more than five years of debate in Congress that started shortly after the IOM released its report. Despite considerable bipartisan support, lawmakers found it difficult to craft language that satisfied all stakeholders. Patient safety legislation actually passed both houses of Congress in 2004, but lawmakers could not resolve differences between the House and Senate versions of the bill.
Sean Donohue, senior policy advisor to Senator Jeffords, says the main obstacles to passing previous bills were consumer advocates who feared a federal law might undermine existing state medical error reporting statutes, and trial lawyers.
"So the challenge was to really create a system of providing confidentiality and privilege for medical error information, while at the same time not undermining the current tort litigation process," Mr. Donohue said. "This bill is the outcome of that."
The measure creates a system for voluntarily reporting medical errors, incidents of "near misses," and enhanced health care quality practices to numerous patient safety organizations (PSOs). The PSOs will be established under guidelines promulgated by the secretary of the U.S. Department of Health and Human Services.
The bill also provides confidentiality protections to prevent people who report medical errors from having the information used against them in lawsuits. Similar protections against inappropriate release of information are provided for data and reports collected and developed by providers and sent to PSOs.
Other provisions direct the PSOs to analyze patient safety data and give health care professionals guidance on how to improve safety and quality, allow patient safety information to be shared, and ensure that information such as medical records remain discoverable in federal or state lawsuits.
Finally, the measure says the new reporting system does not supercede medical error reporting laws in Texas and 11 other states. Mr. Donohue says that provision was critical in getting consumer groups on board.
Supporters of the bill say the confidentiality provisions were critical to making the error reporting process truly work. "When physicians can report errors in a voluntary and confidential manner, everyone benefits," Dr. Hill said. "Future errors can be avoided as we learn from past mistakes. This law strikes the proper balance between confidentiality and the need to ensure responsibility throughout the health care system."
How quickly the new reporting system will be up and running is anybody's guess. The legislation does not specify any time line for certifying the new PSOs. As of late August, the U.S. Department of Health and Human Services was developing guidelines for certification.
Mr. Donohue says the law does not limit the number of PSOs. He believes many organizations already collecting medical error data and performing root cause analysis of errors likely will apply to be PSOs. Among groups that have expressed interest are the Joint Commission on Accreditation of Healthcare Organizations and several of the Medicare quality improvement organizations (QIOs).
A spokesperson for the TMF Health Quality Institute (formerly the Texas Medical Foundation), the Texas Medicare QIO, says that organization has not yet decided whether to apply to become a PSO.
Starr West, director of health care quality for the Texas Hospital Association, says hospitals supported the new patient safety law but are concerned that an unlimited number of PSOs may make it difficult to aggregate data, analyze trends, and share information.
"If we have four or five patient safety organizations just in Texas and then have others that are national, [the data] will be so fragmented that there can't be much learning from it," Ms. West said.
She says it is important that the Department of Health and Human Services develop a standardized way of reporting so that all the PSOs can share data.
"It's going to require not necessarily every patient safety organization collecting data in the same format but being able to map it to a common format so we can learn from it," Ms. West said. "Otherwise, we are going to have little silos of patient safety organizations with little pieces of the pie, and it will never come together."
Ken Ortolon can be reached by telephone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by e-mail at Ken Ortolon.
TMA Launches Patient Safety Committee
Texas Medical Association President Robert T. Gunby Jr., MD, made improving patient safety a priority for his presidency when he was sworn in last May. Now he has created a Select Committee on Patient Safety to lead the association's efforts.
The select committee, which Dr. Gunby will chair, held its first meeting during TMA Summit in September. It will develop a package of patient safety legislation to be filed in the Texas Legislature in 2007, as well as lead TMA's participation in the Institute of Health Care Improvement's 100,000 Lives Campaign.
The panel also will coordinate with the TMF Health Quality Institute's efforts to improve safety and enhance quality for Medicare patients. It will work with TMF to educate physicians about U.S. Centers for Medicare & Medicaid Services pay-for-performance initiatives and commercial performance incentive programs such as Bridges to Excellence. Finally, it will create an electronic clearinghouse or resource center for physicians on patient safety.
In addition to Dr. Gunby, Council on Socioeconomics Chair Susan M. Strate, MD, and former Council on Scientific Affairs Chair Michael E. Speer, MD, will serve on the committee as vice chairs.
Other members include Lewis E. Foxhall, MD, and Angel M. Rios, MD, from the Council on Socioeconomics; Austin I. King, MD, and E. Linda Villarreal, MD, from the Council on Legislation; Robert H. Emmick Jr., MD, Carla F. Ortique, MD, and Don R. Read, MD, from the Patient-Physician Advocacy Committee; Stanley Fisch, MD, and Lisa Nash, MD, from the Council on Medical Education; and Laurie J. Sutor, MD, and Maya B. Bledsoe, MD, from the Council on Scientific Affairs.
Norman H. Chenven, MD, executive vice president of Austin Regional Clinic; William G. Gamel, MD, chief executive officer of the TMF Health Quality Institute; and former Texas Medical Liability Trust Chair Howard R. Marcus, MD, will serve as consultants to the committee.
Dr. Gunby says federal legislation creating a voluntary and confidential system for medical error reporting was a major step forward in improving patient care. "I hope we can get the same done at the state level to allow information to be gathered without the threat of liability so we can see where there are system problems that we can fix," he said.
He hopes the committee can produce "concrete ideas" to reduce adverse outcomes and decrease risks to patients. That includes reducing surgical infections and adverse drug reactions and improving use of proven practices.
"Sentinel Events" Already Reported in Texas
Since 2003, hospitals and other health care institutions in Texas have been required to report "sentinel events" to the Texas Department of State Health Services (DSHS).
House Bill 1614, authored by Rep. Vicki Truitt (R-Keller), requires hospitals, ambulatory surgical centers, and mental hospitals to make annual reports to DSHS. The agency is responsible for aggregating the data for public release, but the hospital name remains confidential.
In addition to reporting events, health facilities must perform a root cause analysis and develop a corrective action plan within 45 days after the event occurs.
Hospitals, ambulatory surgical centers, and mental hospitals are required to report:
- A medication error resulting in a patient's unanticipated death or major permanent loss of bodily function unrelated to the natural course of the illness or underlying condition;
- A perinatal death unrelated to a congenital condition in an infant with a birth weight greater than 2,500 grams;
- The abduction of a newborn infant from the hospital, or the discharge of an infant into the custody of a person whom the hospital knew, or should have known, did not have legal custody;
- The suicide of a patient receiving care 24 hours a day;
- The sexual assault of a patient during treatment or while the patient was on the premises;
- A hemolytic transfusion reaction in a patient resulting from transfusion of the wrong blood type;
- A surgical procedure on the wrong patient or on the wrong body part;
- A foreign object accidentally left in a patient during a procedure; and,
- A patient death or serious disability associated with the improper use of a device designed for patient care.
Hospitals and ambulatory surgical centers submitted their first error reports to DSHS under the new law beginning in July 2004. DSHS likely will release its first report of the compiled data later this year.
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