Patient Safety and Quality Improvement Act of 2005

Bill: 109-hr-3205
Sponsor: Rep. Bilirakis, Michael [R-FL-9]
Introduced: 2005-07-12 in the House
Policy area: Health
Subjects: Accreditation (Medical care)
Administrative procedure
Administrative remedies
Associations, institutions, etc.
Civil Rights and Liberties, Minority Issues
Civil actions and liability
Commerce
Communication in medicine
Computer software
Computers
Confidential communications
Conflict of interests
Congress
Congressional investigations
Congressional reporting requirements
Cost effectiveness
Data banks
Department of Health and Human Services
Disciplining of employees
Discovery (Law)
Dismissal of employees
Drug industry
Drugs
Economics and Public Finance
Electronic data interchange
Employee rights
Evidence (Law)
Federal aid to health facilities
Fines (Penalties)
Freedom of information
Government Operations and Politics
Government paperwork
Governmental investigations
Grants-in-aid
Health information systems
Health surveys
Hospital care
Hospitals
Identification devices
Information technology
Injunctions
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
Performance measurement
Pharmacists
Physicians
Preventive medicine
Quality of care
Right of privacy
Science, Technology, Communications
Standards
State laws
Subpoena
Technological innovations
Technology assessment
Wage restitution
Whistle blowing

Summary:
action_date: 2005-07-12
text: 
Patient Safety and Quality Improvement Act - Amends the Public Health Service Act to protect patient safety work product from being subject to certain disclosures, including pursuant to a civil or administrative subpoena. Defines &quot;patient safety work product&quot; to mean a document or communication that: (1) is developed by a provider for the purpose of reporting to a patient safety organization (PSO); (2) is created by a PSO; or (3) would reveal deliberations or analytic process of a patient safety evaluation system.
 
Prohibits: (1) a provider from using the good faith reporting of information to a PSO against an individual in an adverse employment action; or (2) a person from disclosing patient safety work product in violation of this Act if such disclosure constitutes a negligent or knowing breach of confidentiality.
 
Requires the Secretary of Health and Human Services to: (1) provide for the establishment and maintenance of a database to receive relevant nonidentifiable patient safety work product; (2) establish a process for certifying PSOs; and (3) develop or adopt voluntary national standards that promote the interoperability of information technology systems involved with health care delivery.
 
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary to require manufacturers, packagers, or labelers of any drug or biological product to include a unique product identifier on the packaging of such drug or product.
 
Allows the Secretary to make grants to qualified practitioners for the purpose of establishing electronic prescription programs.
 
Requires the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to assess the effectiveness of the use of electronic prescription programs. 
 
Requires the Secretary to make grants to hospitals and health care providers for acquiring or implementing information technologies.

action_date: 2005-07-27
text: 
Patient Safety and Quality Improvement Act of 2005 - Amends the Public Health Service Act to designate patient safety work product as privileged and not subject to: (1) a subpoena or discovery in a civil, criminal, or administrative disciplinary proceeding against a provider; (2) disclosure under the Freedom of Information Act (FOIA) or a similar law; (3) admission as evidence in any civil, criminal, or administrative proceeding; or (4) admission in a professional disciplinary proceeding. Defines &quot;patient safety work product&quot; as any data, reports, records, memoranda, analysis, or written or oral statements which: (1) are assembled or developed by a provider for reporting to a patient safety organization (PSO); (2) are developed by a PSO for patient safety activities and which could result in improved patient safety or health care quality or outcomes; or (3) identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
 
Designates such work product as confidential, but permits: (1) disclosure for use in a criminal proceeding after a court determines that such work product contains evidence of a criminal act and is material to the proceeding and not reasonably available from any other source; (2) disclosure to the extent required to seek redress for violations through a civil action; and (3) disclosure if authorized by each provider identified in such work product.
 
Excludes certain disclosures from confidentiality protection, including: (1) disclosures to carry out patient safety activities; (2) disclosures of nonidentifiable work product; (3) disclosures otherwise allowed under Health Insurance Portability and Accountability Act of 1996 (HIPAA) confidentiality regulations to entities carrying out sanctioned research, evaluation, or demonstration products; (4) disclosures by a provider to the Food and Drug Administration (FDA); (5) voluntary disclosures by a provider to the provider's accrediting body; (6) disclosures necessary for business operations consistent with the goals of this Act; (7) disclosures to law enforcement authorities relating to the commission of a crime if the person making the disclosure reasonably believes the disclosure is necessary; and (8) disclosures that do not include materials that assess the quality of care of an identifiable provider or pertain to actions or failures to act by an identifiable provider by a person other than a PSO. Excludes from privilege any voluntary disclosure of nonidentifiable work product.
 
Instructs that privilege and confidentiality of work product continues for disclosures under this Act, with certain exceptions. Prevents a PSO from being compelled to disclose information collected or developed unless such information is identified, is not work product, and is not reasonably available from another source.
 
Prohibits an accrediting body from: (1) taking an accrediting action against a provider based on the provider's good faith participation in the collection, development, reporting, or maintenance of work product in accordance with this Act; and (2) requiring a provider to reveal communications with any PSO. Prevents a provider from taking an adverse employment action against an individual for the good faith reporting of information.
 
Sets forth penalties for the disclosure of identifiable work product in knowing or reckless violation of this Act. Allows an individual to bring a civil action to enjoin any act or practice that violates this Act.
 
Declares that this Act shall not: (1) limit greater privileges or confidentiality protections under federal, state, or local laws; (2) limit, alter, or affect the legal requirements pertaining to information that is not privileged or confidential; (3) alter or affect the implementation of HIPAA confidentiality regulations; (4) limit the authority of any provider, PSO, or other entity to require greater confidentiality or delegate authority to make disclosures; (5) preempt or affect any state law requiring a provider to report information that is not work product; (6) limit, alter, or affect any requirement for reporting safety information to the FDA; or (7) prohibit any person from conducting additional analysis.
 
Requires the Secretary to report to Congress on effective strategies for reducing medical errors and increasing patient safety.
 
Requires the Secretary to facilitate the creation of and maintain a network of patient safety databases that: (1) provide an interactive evidence-based management resource for providers, PSOs, and other entities; and (2) have the capacity to accept, aggregate across the network, and analyze voluntarily reported nonidentifiable work product. Requires the Secretary to assess the feasibility of providing for a single point of access to the network for qualified researchers for information aggregated across the network and, if feasible, provide for implementation. Allows the Secretary to determine common formats for reporting to the databases that are consistent with the administration simplification provisions of the Social Security Act. Requires that information reported to the databases be used to analyze national and regional statistics and be made available to the public.
 
Requires PSOs to submit an initial certification to the Secretary and renew their certification every three years. Sets forth criteria for certification.
 
Requires the Secretary to: (1) determine if the initial and subsequent certifications meet the requirements of this Act; and (2) compile and maintain a listing of certified PSOs. Makes provisions for work product if a PSO's certification is expired or revoked.
 
Allows the Secretary, acting through the Director of the Agency for Healthcare Research and Quality (AHRQ), to provide technical assistance to PSOs.
 
Requires the Comptroller General to study the effectiveness of this Act.


Legislative actions:
action_date: 2005-07-27
text: Placed on the Union Calendar, Calendar No. 117.
action_date: 2005-07-27
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-197.
action_date: 2005-07-27
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-197.
action_date: 2005-07-20
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2005-07-20
text: Committee Consideration and Mark-up Session Held.
action_date: 2005-07-14
text: Forwarded by Subcommittee to Full Committee by Voice Vote.
action_date: 2005-07-14
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2005-07-14
text: Referred to the Subcommittee on Health.
action_date: 2005-07-12
text: Referred to the House Committee on Energy and Commerce.
action_date: 2005-07-12
text: Introduced in House
action_date: 2005-07-12
text: Introduced in House