Bill summaries are authored by CRS.

Shown Here:
Passed Senate amended (07/22/2004)

Patient Safety and Quality Improvement Act of 2004 - Amends the Public Health Service Act to designate patient safety data as privileged and not subject to: (1) a subpoena, discovery, disclosure, or admission as evidence in any Federal, State, or local civil, criminal, or administrative proceeding; (2) disclosure pursuant to a Freedom of Information Act request; or (3) use in a disciplinary proceeding against a provider. Defines "patient safety data" as any data, reports, records, memoranda, analyses, or statements that could result in improved patient safety, health care quality, or health care outcomes.

Designates patient safety data as confidential, but permits the disclosure of patient safety data by a provider or patient safety organization (PSO) if such disclosure is a voluntary disclosure of non-identifiable data or if such data: (1) contains evidence, to be used in a criminal proceeding, of a wanton and criminal act to directly harm the patient; (2) is disclosed to a provider or patient safety organization to carry out patient safety organization activities; (3) is disclosed to carry out authorized patient safety research; (4) is disclosed to an accrediting body of a provider; or (5) is voluntarily disclosed for public health surveillance with the consent of each provider who provided or who is identified in such data. Defines "patient safety organization" as an organization certified by the Secretary of Health and Human Services that conducts efforts to improve patient safety and the quality of health care delivery through the collection and analysis of patient safety data.

Declares that privilege and confidentiality of patient safety data continues for disclosures under this Act, except for data that is disclosed in open court or that is non-identifiable. Prohibits any action against a PSO to compel disclosure of information, unless such information is specifically identified, is not patient safety data, and cannot otherwise be obtained.

Prohibits an accrediting body from: (1) taking any accrediting action against a provider based on the provider's good faith participation in collecting, developing, reporting or maintaining patient safety data; or (2) requiring a provider to reveal its communications with any PSO. Prevents a provider from taking an adverse employment action against an individual based upon the good faith reporting of information. Allows the Secretary to impose and collect fines for the negligent or intentional disclosure of patient safety data in violation of the confidentiality provisions of this Act.

Allows civil actions for violations of this Act.

Provides that the privilege provided for under this Act does not apply to States or State entities, unless such State has consented to be subject to such civil actions.

Declares that this Act does not: (1) limit other privileges available that provide greater confidentiality protections under Federal, State, or local laws; (2) affect the requirements of Federal, State, or local law pertaining to patient-related data that is not privileged or confidential under this Act; (3) affect the implementation of the Health Insurance Portability and Accountability Act of 1996 or the Social Security Act; (4) limit the authority of providers or PSOs from contracting to require greater confidentiality or delegate the authority to make permitted disclosures; or (5) prohibit a provider from reporting crime to law enforcement authorities, so long as the provider does not disclose patient safety data in making such a report.

Requires the Secretary to maintain a patient safety network of databases that has the capacity to accept, aggregate, and analyze non-identifiable patient safety data voluntarily reported and that provides an interactive resource for providers and PSOs. Allows the Secretary to determine common formats for reporting to the databases. Provides that such formats shall be consistent with the administration simplification provisions of the Social Security Act.

Requires PSOs to submit an initial certification to the Secretary and to renew their certification every three years. Requires the Secretary to: (1) compile and maintain a current list of certified PSOs; and (2) remove from the list entities whose certification expires or is revoked. Makes provisions for the patient safety data if a PSO's certification is expired or revoked.

Allows the Secretary, acting through the Director of the Agency for Healthcare Research and Quality, to provide technical assistance to PSOs.

Directs the Secretary to: (1) develop or adopt voluntary national standards, within three years, to promote the electronic exchange of health care information; (2) provide for the ongoing review and periodic updating of these standards; and (3) disseminate these standards and updates.

Authorizes appropriations.

Directs the Secretary to contract with a research organization to study: (1) the extent to which labor and technological advances have contributed to increased national spending on health care; (2) the extent to which the early introduction and integration of innovative medical technologies and therapies may affect the overall productivity and quality of health care; and (3) the relationship of such technologies and therapies to patient safety, patient benefit, health care quality, and health care costs.

Sets forth reporting requirements.