Patient Safety and Quality Improvement Act of 2003

Bill: 108-s-720
Sponsor: Sen. Jeffords, James M. [I-VT]
Introduced: 2003-03-26 in the Senate
Policy area: Health
Subjects: Accreditation (Medical care)
Administrative procedure
Administrative remedies
Associations, institutions, etc.
Civil Rights and Liberties, Minority Issues
Communication in medicine
Confidential communications
Congress
Congressional reporting requirements
Data banks
Department of Health and Human Services
Disciplining of employees
Discovery (Law)
Economics and Public Finance
Electronic data interchange
Employee rights
Evidence (Law)
Federal aid programs
Fines (Penalties)
Freedom of information
Government Operations and Politics
Government paperwork
Governmental investigations
Health information systems
Health surveys
Hospital care
Information technology
Labor and Employment
Law
Licenses
Medical economics
Medical malpractice
Medical personnel
Medical records
Medical research
Medical statistics
Medical technology
Patients' rights
Physicians
Preventive medicine
Quality of care
Right of privacy
Science, Technology, Communications
Standards
State laws
Subpoena
Technological innovations
Technology assessment
Whistle blowing

Summary:
action_date: 2003-03-26
text: Patient Safety and Quality Improvement Act - Amends the Public Health Service Act to make patient safety data privileged and confidential. Excludes such data from subpoena, discovery, disclosure under the Freedom of Information Act (FOIA), evidentiary use, or any credentialing or licensing situation. Permits disclosures necessary to the proper management and administration of the patient safety organization, including maintenance of a patient's medical record, in a disciplinary proceeding relating to a provider, or as needed by the Food and Drug Administration for regulatory purposes.
Authorizes the establishment of a database for non-identifiable patient safety data, consistent, if practicable, with the administrative simplification provisions of the Social Security Act.
Authorizes technical assistance, including annual meetings for patient safety organizations.
Requires the Secretary of Health and Human Services to develop or adopt voluntary national standards promoting the integration of health care information technology systems.
Requires the Secretary to contract for and report to Congress on a study assessing the impact of medical technologies and therapies on patient safety and benefit, health care quality and costs, as well as productivity growth.
Directs the Attorney General to survey and report to Congress on State laws and their interpretation as they relate to patient safety data peer review systems.
action_date: 2003-11-17
text: 
Patient Safety and Quality Improvement Act of 2003 - 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 &quot;patient safety data&quot; as any data, reports, records, memoranda, analyses or statements that could result in improved patient safety or 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 data: (1) contains evidence, to be used in a criminal proceeding, of an intentional act to directly harm the patient; (2) relates to the quality, safety, or effectiveness of a product or activity regulated by the Food and Drug Administration (FDA), and is reported to the FDA; (3) is a voluntary disclosure of non-identifiable data; (4) relates to public health surveillance, investigation, or other public health activities reported to the Centers for Disease Control and Prevention (CDC); (5) is necessary to improve patient safety or health care quality or health care outcomes; (6) is necessary for the functioning of a PSO; (7) is used to provide treatment, improve patient safety, health care quality or administrative efficiency, or any other customary activity of a provider; (8) is used by a provider to obtain payment; (9) is communicated among PSOs; (10) is used for patient safety research, evaluation, or demonstration projects authorized by the Director of the Agency for Healthcare Research and Quality; or (11) is disclosed to an accrediting body of a provider. Defines &quot;patient safety organization&quot; 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.
 
Instructs that privilege and confidentiality of patient safety data continues for disclosures under this Act, and prohibits any action against a PSO to compel such disclosures, unless the disclosure is for use in a criminal proceedings, to the FDA, to the CDC, or is non-identifiable information. 
 
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; and (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.
 
States that the privilege and confidentiality protections of this Act shall 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.
 
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 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 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 listing 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, 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 and benefit, health care quality, and health care costs.
 
Sets forth reporting requirements.


Legislative actions:
action_date: 2004-09-07
text: Message on Senate action sent to the House.
action_date: 2004-07-22
text: Returned to the Calendar. Calendar No. 387.
action_date: 2004-07-22
text: Senate passed companion measure H.R. 663 in lieu of this measure by Unanimous Consent. (consideration: CR S8632-8633)
action_date: 2004-07-22
text: Senate incorporated this measure in H.R. 663 as an amendment.
action_date: 2004-07-22
text: Read the third time by Unanimous Consent.
action_date: 2004-07-22
text: Measure laid before Senate by unanimous consent. (consideration: CR S8627-8632; text of measure as reported in Senate: CR S8627-8631)
action_date: 2003-11-17
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 387.
action_date: 2003-11-17
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. With written report No. 108-196. Additional views filed.
action_date: 2003-11-17
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. With written report No. 108-196. Additional views filed.
action_date: 2003-07-23
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2003-03-26
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-03-26
text: Introduced in Senate