3.0.0 663 2023-01-15T22:48:24Z 2023-01-15T22:48:24Z House H HR 2003-02-11 108 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Discharged from 2004-07-23T00:53:29Z Referred to 2003-03-13T17:45:04Z hsif00 Energy and Commerce Committee House Standing Reported by 2003-03-06T22:19:23Z Markup by 2003-02-12T22:34:26Z Referred to 2003-02-11T17:33:20Z H. Rept. 108-28 Patient Safety and Quality Improvement Act of 2003 108 720 S 2004-09-07 Message on Senate action sent to the House. Related document Senate Procedurally-related Senate Related bill House Procedurally-related Senate 2004-09-07 Senate Message on Senate action sent to the House. Floor 2004-07-22 Senate See also S. 720. Floor 2004-07-22 Senate Senate insists on its amendment, asks for a conference, appoints conferees Gregg; Frist; Enzi; Alexander; Kennedy; Dodd; Jeffords. ResolvingDifferences 2004-07-22 Senate Passed Senate with an amendment by Unanimous Consent. Floor 2004-07-22 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. Floor 17000 9 Library of Congress 2004-07-22 Senate Senate struck all after the Enacting Clause and substituted the language of S. 720 amended. Floor 2004-07-22 Senate Measure laid before Senate by unanimous consent. (consideration: CR S8632-8633) Floor 2004-07-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. Discharge 2004-07-22 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. Committee 14500 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2003-03-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2003-03-12 17:33:21 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2003-03-12 17:32:25 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) Floor H37300 2 House floor actions 60 https://clerk.house.gov/evs/2003/roll060.xml House 108 2003-03-12T22:32:25Z 1 2003-03-12 17:32:25 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) Floor 8000 9 Library of Congress 60 https://clerk.house.gov/evs/2003/roll060.xml House 108 2003-03-12T22:32:25Z 1 2003-03-12 17:26:26 Considered as unfinished business. (consideration: CR H1777-1778) Floor H30000 2 House floor actions 2003-03-12 13:22:14 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. Floor H37220 2 House floor actions 2003-03-12 13:08:32 DEBATE - The House proceeded with forty minutes of debate on H.R. 663. Floor H8D000 2 House floor actions 2003-03-12 13:08:27 Considered under suspension of the rules. (consideration: CR H1766-1774) Floor H30000 2 House floor actions 2003-03-12 13:08:09 Mr. Bilirakis moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2003-03-06 Placed on the Union Calendar, Calendar No. 19. Calendars H12410 2 House floor actions U00019 2003-03-06 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-28. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2003-03-06 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-28. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2003-02-12 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2003-02-12 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2003-02-11 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2003-02-11 Introduced in House IntroReferral Intro-H 9 Library of Congress 2003-02-11 Introduced in House IntroReferral 1000 9 Library of Congress B000463 Rep. Bilirakis, Michael [R-FL-9] MICHAEL BILIRAKIS R FL 9 N B000944 Rep. Brown, Sherrod [D-OH-13] Sherrod Brown D OH 13 2003-02-11 True T000058 Rep. Tauzin, W. J. (Billy) [R-LA-3] W. TAUZIN R LA J. 3 2003-02-11 True D000355 Rep. Dingell, John D. [D-MI-15] JOHN DINGELL D MI D. 15 2003-02-11 True B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2003-02-11 True W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 2003-02-11 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2003-02-11 True M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2003-02-11 True G000439 Rep. Greenwood, James C. [R-PA-8] JAMES GREENWOOD R PA C. 8 2003-02-11 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2003-02-11 True B001135 Rep. Burr, Richard [R-NC-5] Richard Burr R NC Mauze 5 2003-02-11 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2003-02-11 True W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2003-02-11 True G000309 Rep. Gordon, Bart [D-TN-6] BART GORDON D TN 6 2003-02-11 True N000159 Rep. Norwood, Charles W. [R-GA-9] CHARLES NORWOOD R GA W. 9 2003-02-11 True D000275 Rep. Deutsch, Peter [D-FL-20] PETER DEUTSCH D FL 20 2003-02-11 True T000459 Rep. Terry, Lee [R-NE-2] LEE TERRY R NE 2 2003-02-11 True R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2003-02-11 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2003-02-11 True E000179 Rep. Engel, Eliot L. [D-NY-17] ELIOT ENGEL D NY L. 17 2003-02-11 True W000784 Rep. Wynn, Albert Russell [D-MD-4] ALBERT WYNN D MD R. 4 2003-02-11 True M000316 Rep. McCarthy, Karen [D-MO-5] KAREN MCCARTHY D MO 5 2003-02-11 True S001004 Rep. Strickland, Ted [D-OH-6] TED STRICKLAND D OH 6 2003-02-11 True C001036 Rep. Capps, Lois [D-CA-23] LOIS CAPPS D CA 23 2003-02-11 True J000110 Rep. John, Christopher [D-LA-7] CHRISTOPHER JOHN D LA 7 2003-02-11 True H000213 Rep. Harman, Jane [D-CA-36] JANE HARMAN D CA 36 2003-02-11 True I000056 Rep. Issa, Darrell E. [R-CA-49] DARRELL ISSA R CA E. 49 2003-02-12 False E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2003-02-12 False G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2003-02-12 False S001045 Rep. Stupak, Bart [D-MI-1] BART STUPAK D MI 1 2003-03-05 False 2003-03-03T06:00:00Z H.R. 663, Patient Safety and Quality Improvement Act http://www.cbo.gov/publication/14299 <p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on February 12, 2003</p> 2003-03-03T06:00:00Z H.R. 663, Patient Safety and Quality Improvement Act https://www.cbo.gov/publication/14299 Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on February 12, 2003 Health 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 Health 00 2003-02-11 Introduced in House 2006-11-28T17:35:40Z 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.]]>

17 2003-03-06 Reported to House with amendment(s) 2006-11-28T17:35:40Z 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.]]>

36 2003-03-12 Passed House amended 2006-11-28T17:35:40Z 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.]]>

35 2004-07-22 Passed Senate amended 2005-01-13T21:43:51Z 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.

]]> Patient Safety and Quality Improvement Act of 2004 Display Title Patient Safety and Quality Improvement Act of 2004 Official Title as Introduced To amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety, and for other purposes. Introduced in House IH Short Titles as Passed House Patient Safety and Quality Improvement Act H House Short Titles as Introduced Patient Safety and Quality Improvement Act Popular Titles Medical Mistakes bill 9 Library of Congress Short Titles as Passed Senate Patient Safety and Quality Improvement Act of 2004 S Senate Short Titles as Reported to House Patient Safety and Quality Improvement Act H House Engrossed Amendment Senate 2004-07-22T04:00:00Z Referred in Senate 2003-03-13T05:00:00Z Engrossed in House 2003-03-12T05:00:00Z Reported in House 2003-03-06T05:00:00Z Introduced in House 2003-02-11T05:00:00Z 2004-09-07 Message on Senate action sent to the House. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.