Patient Safety and Quality Improvement Act of 2004

Bill: 108-hr-663
Sponsor: Rep. Bilirakis, Michael [R-FL-9]
Introduced: 2003-02-11 in the House
Policy area: Health
Subjects: Accreditation (Medical care)
Administrative procedure
Administrative remedies
Associations, institutions, etc.
Civil Rights and Liberties, Minority Issues
Commerce
Communication in medicine
Computer networks
Computer software
Computers
Confidential communications
Congress
Congressional reporting requirements
Cost effectiveness
Data banks
Department of Health and Human Services
Disciplining of employees
Discovery (Law)
Drug adulteration
Drug industry
Drugs
Economics and Public Finance
Electronic data interchange
Employee rights
Evidence (Law)
Federal aid programs
Federal aid to health facilities
Finance and Financial Sector
Fines (Penalties)
Freedom of information
Government Operations and Politics
Government paperwork
Governmental investigations
Health information systems
Health surveys
Hospital care
Hospitals
Identification devices
Information technology
Labeling
Labor and Employment
Law
Licenses
Medical economics
Medical malpractice
Medical personnel
Medical records
Medical research
Medical statistics
Medical technology
Packaging
Patient satisfaction
Patients' rights
Peer review organizations (Medicine)
Physicians
Preventive medicine
Product coding
Quality of care
Right of privacy
Science, Technology, Communications
Standards
State laws
Subpoena
Technological innovations
Technology assessment
Whistle blowing

Summary:
action_date: 2003-02-11
text: Patient Safety and Quality Improvement Act - Amends the Public Health Service Act to make "patient safety work product" privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. Imposes a civil penalty on providers who violate the privileged status of patient safety work product.
Directs the Secretary of Health and Human Services to establish and maintain a database to receive relevant nonidentifiable patient safety work product, consistent, if practicable, with the administrative simplification provisions of the Social Security Act. Permits the Secretary to provide to patient safety organizations and to States technical assistance with reporting systems for health care errors.
Directs the Secretary to establish a process for the Secretary or another approved Federal or State governmental organization to certify patient safety organizations.
Requires the Secretary to develop or adopt voluntary national standards promoting the interoperability of information technology systems involved with health care delivery.
Requires the Secretary to issue and periodically revise regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the Food and Drug Administration, or the packager or labeler of such a product, to include a unique product identifier on the packaging.
action_date: 2003-03-06
text: Patient Safety and Quality Improvement Act - (Sec. 3) Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery.
Prohibits patient safety work product: (1) from being subject to a civil or administrative subpoena or order; (2) from being required to be admitted as evidence in any State or Federal civil or administrative proceeding; or (3) if the patient safety work product is identifiable information and is received by a national accreditation organization in its capacity as a patient safety organization, from being used by such organization in an accreditation action against the provider that reported the information. Requires disclosure to the Food and Drug Administration for safety purposes.
Protects individuals who report information to a patient safety organization from adverse employment actions. Permits the voluntary disclosure of identifiable information by a provider or patient safety organization under specified conditions, including that it be for improving quality and safety. Imposes a civil penalty for violating this section. Declares that patient safety work product remains confidential, even if a patient safety organization has its certification revoked or otherwise ceases to exist.

Directs the Secretary of Health and Human Services to establish and maintain a database to receive relevant nonidentifiable patient safety work product, consistent with the administrative simplification provisions of the Social Security Act.
Permits the Secretary to provide to patient safety organizations and to States: (1) technical assistance with reporting systems for health care errors; and (2) guidance on the type of data to be voluntarily submitted to any National Patient Safety Database.
Directs the Secretary to establish a process for the Secretary or another approved Federal or State governmental organization to certify patient safety organizations. Sets forth criteria a patient safety organization must meet to be certified.
(Sec. 4) Requires the Secretary to develop or adopt voluntary national standards promoting the interoperability of information technology systems involved with health care delivery. Requires the Secretary to take into account the costs to the health care system from the standards and any efficiencies resulting from the adoption of the standards.
(Sec. 5) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to issue and periodically revise regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the Food and Drug Administration, or the packager or labeler of such a product, to include a unique product identifier on the packaging. Considers as misbranded any drug or biological product without such a unique product identifier. Permits the Secretary to waive these regulatory requirements or add provisions in order to safeguard the public health.
(Sec. 6) Allows the Secretary of Health and Human Services to make grants to physicians and certain other health care professionals for the purpose of establishing electronic prescription programs. Requires grantees to fund 50 percent of the cost of such programs. Directs the Agency for Healthcare Research and Quality to conduct a study of the cost-effectiveness of electronic prescription programs. Establishes reporting requirements.
(Sec. 7) Directs the Secretary of Health and Human Services to make grants to hospitals and other health care providers for new or improved computer hardware and software for the purposes of improving patient safety and health care quality and reducing adverse events and complications from medication errors. Requires grantees to fund 50 percent of the cost of such information technologies. Permits the Secretary to provide technical assistance to applicants and grantees. Establishes reporting requirements.
(Sec. 8) Authorizes appropriations through FY 2005.
action_date: 2003-03-12
text: Patient Safety and Quality Improvement Act - 
Title I: Patient Safety and Quality Improvement
 - (Sec. 101) Amends the Public Health Service Act to make patient safety work product privileged information. Defines "patient safety work product" as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. Defines a "patient safety organization" as an organization, certified under this Act, that collects such information with the goal of improving patient safety and the quality of health care delivery.
Prohibits patient safety work product: (1) from being subject to a civil or administrative subpoena or order; (2) from being required to be admitted as evidence in any State or Federal civil or administrative proceeding; or (3) if the patient safety work product is identifiable information and is received by a national accreditation organization in its capacity as a patient safety organization, from being used by such organization in an accreditation action against the provider that reported the information. Requires disclosure to the Food and Drug Administration for safety purposes.
Protects individuals who report information to a patient safety organization from adverse employment actions. Permits the voluntary disclosure of identifiable information by a provider or patient safety organization under specified conditions, including that it be for improving quality and safety. Imposes a civil penalty for violating this section. Declares that patient safety work product remains confidential, even if a patient safety organization has its certification revoked or otherwise ceases to exist.
Directs the Secretary of Health and Human Services to establish and maintain a database to receive relevant nonidentifiable patient safety work product, consistent with the administrative simplification provisions of the Social Security Act.
Permits the Secretary to provide to patient safety organizations and to States: (1) technical assistance with reporting systems for health care errors; and (2) guidance on the type of data to be voluntarily submitted to any National Patient Safety Database.
Directs the Secretary to establish a process for the Secretary or another approved Federal or State governmental organization to certify patient safety organizations. Sets forth criteria a patient safety organization must meet to be certified.
(Sec. 102) Requires the Secretary to develop or adopt voluntary national standards promoting the interoperability of information technology systems involved with health care delivery. Requires the Secretary to take into account the costs to the health care system from the standards and any efficiencies resulting from the adoption of the standards.
(Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to issue and periodically revise regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the Food and Drug Administration, or the packager or labeler of such a product, to include a unique product identifier on the packaging. Considers as misbranded any drug or biological product without such a unique product identifier. Permits the Secretary to waive these regulatory requirements or add provisions in order to safeguard the public health.
(Sec. 104) Allows the Secretary of Health and Human Services to make grants to physicians and certain other health care professionals for the purpose of establishing electronic prescription programs. Requires grantees to fund 50 percent of the cost of such programs. Directs the Agency for Healthcare Research and Quality to conduct a study of the cost-effectiveness of electronic prescription programs. Establishes reporting requirements.
(Sec. 105) Directs the Secretary of Health and Human Services to make grants to hospitals and other health care providers for new or improved computer hardware and software for the purposes of improving patient safety and health care quality and reducing adverse events and complications from medication errors. Requires grantees to fund 50 percent of the cost of such information technologies. Permits the Secretary to provide technical assistance to applicants and grantees. Establishes reporting requirements.
(Sec. 106) Authorizes appropriations through FY 2005.

Title II: Medical Information Technology Advisory Board
 - (Sec. 201) Amends the title XI (General Provisions) of the Social Security Act to direct the Secretary to appoint a Medical Information Advisory Board (the MITAB). Declares that the MITAB shall make recommendations to the Secretary regarding medical information technology, including on: (1) the best current practices in medical information technology; and (2) methods of implementing records security. Establishes reporting requirements.
Allows Federal agencies to detail employees to the MITAB, and permits the MITAB to secure such information from Federal agencies as is allowed under specified Federal law pertaining to Government organization and employees.
Applies the provisions of the Federal Advisory Committee Act to the MITAB.
Terminates the MITAB 30 days after the submission of its final report.
Authorizes appropriations.
action_date: 2004-07-22
text: 
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 &quot;patient safety data&quot; 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 &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.
 
 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.


Legislative actions:
action_date: 2004-09-07
text: Message on Senate action sent to the House.
action_date: 2004-07-22
text: See also S. 720.
action_date: 2004-07-22
text: Senate insists on its amendment, asks for a conference, appoints conferees Gregg; Frist; Enzi; Alexander; Kennedy; Dodd; Jeffords.
action_date: 2004-07-22
text: Passed Senate with an amendment by Unanimous Consent.
action_date: 2004-07-22
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
action_date: 2004-07-22
text: Senate struck all after the Enacting Clause and substituted the language of S. 720 amended.
action_date: 2004-07-22
text: Measure laid before Senate by unanimous consent. (consideration: CR S8632-8633)
action_date: 2004-07-22
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2004-07-22
text: Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
action_date: 2003-03-13
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-03-12
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2003-03-12
text: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 418 - 6 (Roll no. 60). (text:  CR H1766-1771)
action_date: 2003-03-12
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 418 - 6 (Roll no. 60).(text:  CR H1766-1771)
action_date: 2003-03-12
text: Considered as unfinished business. (consideration:  CR H1777-1778)
action_date: 2003-03-12
text: At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
action_date: 2003-03-12
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 663.
action_date: 2003-03-12
text: Considered under suspension of the rules. (consideration:  CR H1766-1774)
action_date: 2003-03-12
text: Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
action_date: 2003-03-06
text: Placed on the Union Calendar, Calendar No. 19.
action_date: 2003-03-06
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-28.
action_date: 2003-03-06
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-28.
action_date: 2003-02-12
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2003-02-12
text: Committee Consideration and Mark-up Session Held.
action_date: 2003-02-11
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-02-11
text: Introduced in House
action_date: 2003-02-11
text: Introduced in House