The Department of Health and Human Services proposed a plan Tuesday to improve the quality and safety of healthcare through the confidential reporting of medical errors. According to the proposed rule, enforcement will include fines as high as $10,000 for breaches.
The proposed rule, mandated under the Patient Safety and Quality Improvement Act of 2005, would encourage hospitals and other healthcare providers to voluntarily report patient safety events to HHS-approved Patient Safety Organizations (PSOs), a collection of organizations both public and not-for-profit.
Hospitals and other providers can voluntarily report patient safety events without fear of new tort liability, an HHS statement said. However, reporting adverse events to PSOs will not relieve organizations from reporting required by other state and federal laws.
J. James Rohack, MD, a board member of the American Medical Association, said the AMA has "eagerly awaited" this proposed rule.
It "will transform the current culture of blame and punishment into one of open communication and prevention," he said. "When healthcare errors can be reported in a voluntary and confidential manner, future errors can be avoided."
HHS' Agency for Healthcare Research and Quality (AHRQ) will administer the rule, while the Office for Civil Rights (OCR) will be the enforcer.
OCR Director Winston Wilkinson said the OCR's enforcement of strong confidential protections will encourage participation.
AHRQ Director Carolyn M. Clancy, MD, said fear of liability or sanctions has kept some willing organizations from participating in current quality efforts, but this rule will help to address that.
"The proposed regulation provides a framework for Patient Safety Organizations to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients," she said. "We want to make the right thing to do the easy thing to do."
The AHRQ will publish information it learns from PSOs, including national and regional statistics and trends and patterns of patient safety events, in its annual National Healthcare Quality Report.
HHS said the 2005 Patient Safety Act was passed partly as a result of the 1999 report "To Err is Human," which estimated between 44,000 and 98,000 people die in U.S. hospitals each year as a result of preventable medical errors.
The HHS is accepting comments on the proposal until April 14.