President Bush signed the Patient Safety and Quality Improvement Act of 2005 on July 29, 2005, describing the legislation as “a critical step towards our goals insuring top quality, patient-driven healthcare for all Americans.”

The Patient Safety Act is intended to create a system for voluntary reporting of medical errors by healthcare providers to a National Patient Safety Database, which information then can be used to advance quality assurance initiatives.

The Patient Safety Act is intended to create a system that will establish a repository for the receipt of the medical reports, provide security to maintain the confidentiality of that information, encourage the use of that information to improve healthcare quality, and protect the reporters of the information.


The mechanisms for the receipt of this information are Patient Safety Organizations and a National Patient Safety Database. A Patient Safety Organization is defined as a public or private organization, or component thereof, that is certified, through a process to be developed by the Department of Health and Human Services, to perform each of the following activities:

a. Conduct, as the organization or component’s primary activity, efforts to improve patient safety and the quality of healthcare delivery;

b. Collect and analyze patient safety work product that is submitted by providers;

c. Develop and disseminate evidence-based information to providers with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;

d. Utilize patient safety work product to carry out activities limited to those described under this paragraph and for the purposes of encouraging a culture of safety and of providing direct feedback and assistance to providers to effectively minimize patient risk;

e. Maintain confidentiality with respect to identifiable information;

f. Provide appropriate security measures with respect to patient safety work product; and

g. Submit non-identifiable information to the Agency consistent with standards established by the Secretary under Section 923(b) for any National Patient Safety Database.

The National Patient Safety Database is intended to work similarly to the National Practitioners Data Bank. HHS is directed to provide for the establishment and maintenance of a database to receive relevant non-identifiable patient safety work product. This information shall be used to analyze national and regional statistics, including trends and patterns of healthcare errors.


The information provided by the Patient Safety Organizations and collected in the National Patient Database is referred to as “Patient Safety Work Product.” This Patient Safety Work Product shall not be subject to civil or administrative subpoena, subject to discovery in connection with a civil or administrative proceeding, subject to disclosure under the Freedom of Information Act or any other similar federal or state law, required to be admitted as evidence or otherwise disclosed in any state or federal civil or administrative proceeding. The reports on information may not be used by any national accreditation organizations or licensing survey teams with respect to the licensing or accreditation of the provider who submitted the report.


In addition to protecting the provider’s licensing, the Act also provides that a provider may not use against any individual in an adverse employment action the fact that the individual reported this information in good faith either to the provider or to a patient safety organization. Adverse employment action is defined to include a failure to promote an individual or provide any other employment related benefit, an adverse evaluation or decision made in relation to accreditation, certification, credentialing or licensing of the individual, and any personnel action that is adverse to the individual concerned.

The Patient Safety Organizations are also defined by statute as business associates for purposes of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).