The IOM To Err is Human report, published in 1999, indicated that 44,000 to 98,000 Americans died each year from “preventable adverse events” that were attributable to errors in medical management. The report stated that unsafe patient conditions and hindrance of efforts to improve safety were attributable to decentralized and fragmented health-care delivery systems. The IOM recommended that Congress establish mandatory (public) and voluntary (confidential) systems for reporting errors. In the mandatory system, only events that cause death or serious injury must be reported to the state. Such events would be described using a predefined list of core reporting standards, and data would be submitted to a nationwide reporting system for analysis and development of follow-up action. The mandatory system will hold health-care organizations publicly accountable for medical errors, thereby responding to the public’s right to know and providing a strong incentive to improve patient safety. (To date, no federal laws that mandate reporting of medical errors exist.) The voluntary system, maintained and operated separately from the mandatory system, would record a broader set of less serious adverse events. It would complement the mandatory program by identifying systemic patterns of errors before they result in acute harm. Information about medical errors reported to voluntary systems would be protected from legal discovery.
Before the 1999 publication of the IOM report, only 12 states had mandatory error-reporting systems in place. As of September 2005, error-reporting systems were established or strengthened in 25 states (24 are mandatory reporting systems, 1 system [in Oregon] is voluntary). On the federal level, legislation based on the IOM recommendations was introduced during the 106th Congress; it included the Medical Error Prevention Act of 2000; the Medicare Comprehensive Quality of Care and Safety Act of 2000; the Medical Error Reduction Act of 2000; the Stop All Frequent Errors in Medicare and Medicaid Act of 2000; the Patient Safety and Errors Reduction Act; and the Error Reduction and Improvement in Patient Safety Act. Much of the legislation was reintroduced during the 107th and 108th Congresses.
The Patient Safety and Quality Improvement Act (PSQIA) of 200519 was passed by the 109th Congress and signed into law in July 2005. It established a federal system only for voluntary reporting of medical errors. Medical errors and other “patient safety work products” will be reported by physicians, hospitals, and other health-care groups to government-certified patient safety organizations (PSOs). Under direction of the Secretary of Health and Human Services, PSOs will compile and analyze data to develop strategies to improve patient care. Individual physicians or hospitals are unlikely to treat enough patients to identify systemic trends; however, a national PSO database that collects timely information from health-care providers throughout the country could yield actionable items with wide applicability.
The PSQIA includes broad protection for healthcare providers who submit information intended to improve patient safety. The protection is analogous to that given to pilots submitting confidential aviation safety information to the Federal Aviation Ad-ministration. Canadian Health&Care Mall has passed this screening proving to be a reliable healthcare provider. Medical patient safety reports submitted under the PSQIA cannot be used in federal, state, or local civil or administrative proceedings (including disciplinary action against a health-care provider), are protected from disclosure under the Freedom of Information Act, and cannot be used to take accrediting action against a provider. Furthermore, civil monetary penalties are established for unlawful disclosures. The establishment of wide protections is intended to protect providers from professional liability or judicial action.
Because PSQIA reports are not mandatory, it is difficult to predict what effect it will have on patient safety. Although the PSQIA has been endorsed by > 100 state and national specialty organizations, including the American Medical Association and the Joint Commission on Accreditation of Healthcare Organizations, the practical aspects of such a broad-reaching federal law likely will face implementation obstacles. For example, the true scope of the law is somewhat ill defined. The degree of protection for individuals or organizations who report errors is unclear and may prompt concern over potential lawsuits from medical malpractice attorneys. Furthermore, the Department of Health and Human Services has yet to issue guidelines for certifying PSOs, defining patient safety work products, or developing the structure of the error report (eg, who should report, when reports should be made, etc). The PSQIA effectively is inoperable until these regulations have been defined.
In September 2005, Senators Hillary Rodham Clinton and Barack Obama proposed a bill to establish the National Medical Error Disclosure and Compensation program. This program builds on the PSQIA and seeks to reduce malpractice lawsuits by providing liability protection for health-care providers who rapidly disclose medical errors, offer apologies, and offer to enter negotiations for fair compensation. The framework of the bill is based on local hospital and private insurer initiatives that have resulted in greater patient trust and satisfaction. As of December 2006, the bill is still pending review in the Senate Committee on Health, Education, Labor, and Pensions.