[Congressional Record (Bound Edition), Volume 149 (2003), Part 5]
[House]
[Pages 5984-5992]
[From the U.S. Government Publishing Office, www.gpo.gov]




               PATIENT SAFETY AND QUALITY IMPROVEMENT ACT

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 663) 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, as amended.
  The Clerk read as follows:

                                H.R. 663

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Patient 
     Safety and Quality Improvement Act''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.

            TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT

Sec. 101. Amendments to Public Health Service Act.

                  ``Part C--Patient Safety Improvement

``Sec. 921. Definitions.
``Sec. 922. Privilege for patient safety work product.
``Sec. 923. National Patient Safety Database.
``Sec. 924. Technical assistance.
``Sec. 925. Certification of patient safety organizations.
Sec. 102. Promoting the diffusion and interoperability of information 
              technology systems involved with health care delivery.
Sec. 103. Required use of product identification technology.
Sec. 104. Grants for electronic prescription programs.
Sec. 105. Grants to hospitals and other health care providers for 
              information technologies.
Sec. 106. Authorization of appropriations for grants under sections 104 
              and 105.

        TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.

Sec. 201. Medical Information Technology Advisory Board.

     SEC. 2. FINDINGS AND PURPOSES.

       (a) Findings.--The Congress finds as follows:
       (1) In 1999, the Institute of Medicine released a report 
     entitled ``To Err Is Human'' that described medical errors as 
     the 8th leading cause of death in the United States, with as 
     many as 98,000 people dying as a result of medical errors 
     each year.
       (2) To address these deaths and injuries due to medical 
     errors, the health care system must identify and learn from 
     such errors so that systems of care can be improved.
       (3) Myriad public and private patient safety initiatives 
     have begun. The Quality Interagency Coordination Task Force 
     has recommended steps to improve patient safety that may be 
     taken by each Federal agency involved in health care and 
     activities relating to these steps are ongoing.
       (4) The Department of Health and Human Services has 
     initiated several patient safety projects. The Joint 
     Commission on Accreditation of Healthcare Organizations 
     issued a patient safety standard that went into effect on 
     July 1, 2001, and the peer review organizations are 
     conducting ongoing studies of clinical performance 
     measurement of care delivered to beneficiaries under the 
     medicare program under title XVIII of the Social Security 
     Act.
       (5) Several steps can be taken now to improve patient 
     safety. For example, according to the Centers for Disease 
     Control and Prevention, hand washing is the single most 
     important means of preventing the spread of infection. 
     Repeated studies indicate that lack of or improper hand 
     washing still contributes significantly to disease 
     transmission in health care settings. Working with experts 
     from the private sector, the Centers for Disease Control and 
     Prevention has drafted ``Guidelines for Hand Hygiene in 
     Healthcare Settings'' setting forth recommendations to 
     promote improved hand hygiene practices and reduce 
     transmission of pathogenic microorganisms to patients and 
     personnel in health care settings.
       (6) According to the Centers for Disease Control and 
     Prevention, nosocomial infections affect approximately 2 
     million patients annually in acute care facilities in the 
     United States at an estimated direct patient care cost of 
     approximately $3.5 billion each year.
       (7) The Congress encourages the continuation and 
     acceleration of private sector efforts to take immediate 
     steps to improve patient safety and recognizes the need for 
     action in the public sector to complement these efforts.
       (8) The research on patient safety unequivocally calls for 
     a learning environment, where providers will feel safe to 
     report health care errors, in order to improve patient 
     safety.
       (9) Voluntary data gathering systems are more supportive 
     than mandatory systems in creating the learning environment 
     referred to in paragraph (8) as stated in the Institute of 
     Medicine's report.
       (10) Promising patient safety reporting systems have been 
     established throughout the United States, and the best ways 
     to structure and use these systems are currently being 
     determined, largely through projects funded by the Agency for 
     Healthcare Research and Quality.
       (11) Many organizations currently collecting patient safety 
     information have expressed a need for protections that will 
     allow them to review protected information so that they may 
     collaborate in the development and implementation of patient 
     safety improvement strategies. Currently, the State peer 
     review protections provide inadequate conditions to allow the 
     sharing of information to promote patient safety.
       (12) In 2001, the Institute of Medicine released a report 
     entitled ``Crossing the Quality Chasm'' that found that the 
     United States health care system does not consistently 
     deliver high-quality care to patients.
       (b) Purposes.--The purposes of this Act are--
       (1) to encourage a culture of safety and quality in the 
     United States health care system by providing for a health 
     care errors reporting system that both protects information 
     and improves patient safety and quality of health care; and
       (2) to ensure accountability by raising standards and 
     expectations for continuous quality improvements in patient 
     safety through the actions of the Secretary of Health and 
     Human Services.

            TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT

     SEC. 101. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

       (a) In General.--Title IX of the Public Health Service Act 
     (42 U.S.C. 299 et seq.) is amended--
       (1) in section 912(c), by inserting ``, in accordance with 
     part C,'' after ``The Director shall'';
       (2) by redesignating part C as part D;
       (3) by redesignating sections 921 through 928, as sections 
     931 through 938, respectively;
       (4) in section 938(1) (as so redesignated), by striking 
     ``921'' and inserting ``931''; and
       (5) by inserting after part B the following:

                  ``PART C--PATIENT SAFETY IMPROVEMENT

     ``SEC. 921. DEFINITIONS.

       ``In this part:
       ``(1) Identifiable information.--The term `identifiable 
     information' means information that is presented in a form 
     and manner that allows the identification of any provider, 
     patient, or reporter of patient safety work product. With 
     respect to patients, such information includes any 
     individually identifiable health information as that term is 
     defined in the regulations promulgated pursuant to section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 (Public Law 104-191; 110 Stat. 2033).
       ``(2) Nonidentifiable information.--The term 
     `nonidentifiable information' means information that is 
     presented in a form and manner that prevents the 
     identification of any provider, patient, or reporter of 
     patient safety work product. With respect to patients, such 
     information must be de-identified consistent with the 
     regulations promulgated pursuant to section 264(c) of the

[[Page 5985]]

     Health Insurance Portability and Accountability Act of 1996 
     (Public Law 104-191; 110 Stat. 2033).
       ``(3) Patient safety evaluation system.--The term `patient 
     safety evaluation system' means a process that involves the 
     collection, management, or analysis of information for 
     submission to or by a patient safety organization.
       ``(4) Patient safety organization.--The term `patient 
     safety organization' means a private or public organization 
     or component thereof that is certified, through a process to 
     be determined by the Secretary under section 925, to perform 
     each of the following activities:
       ``(A) The conduct, as the organization or component's 
     primary activity, of efforts to improve patient safety and 
     the quality of health care delivery.
       ``(B) The collection and analysis of patient safety work 
     product that is submitted by providers.
       ``(C) The development and dissemination of evidence-based 
     information to providers with respect to improving patient 
     safety, such as recommendations, protocols, or information 
     regarding best practices.
       ``(D) The utilization of patient safety work product to 
     carry out activities limited to those described under this 
     paragraph and for the purposes of encouraging a culture of 
     safety and of providing direct feedback and assistance to 
     providers to effectively minimize patient risk.
       ``(E) The maintenance of confidentiality with respect to 
     identifiable information.
       ``(F) The provision of appropriate security measures with 
     respect to patient safety work product.
       ``(G) The submission of nonidentifiable information to the 
     Agency consistent with standards established by the Secretary 
     under section 923(b) for any National Patient Safety 
     Database.
       ``(5) Patient safety work product.--
       ``(A) The term `patient safety work product' means any 
     document or communication (including any information, report, 
     record, memorandum, analysis, deliberative work, statement, 
     or root cause analysis) that--
       ``(i) except as provided in subparagraph (B), is developed 
     by a provider for the purpose of reporting to a patient 
     safety organization, and is reported to a patient safety 
     organization;
       ``(ii) is created by a patient safety organization; or
       ``(iii) would reveal the deliberations or analytic process 
     of a patient safety evaluation system (as defined in 
     paragraph (3)).
       ``(B)(i) Patient safety work product described in 
     subparagraph (A)(i)--
       ``(I) does not include any separate information described 
     in clause (ii); and
       ``(II) shall not be construed to include such separate 
     information merely by reason of inclusion of a copy of the 
     document or communication involved in a submission to, or the 
     fact of submission of such a copy to, a patient safety 
     organization.
       ``(ii) Separate information described in this clause is a 
     document or communication (including a patient's medical 
     record or any other patient or hospital record) that is 
     developed or maintained, or exists, separately from any 
     patient safety evaluation system.
       ``(C) Information available from sources other than a 
     patient safety work product under this section may be 
     discovered or admitted in a civil or administrative 
     proceeding, if discoverable or admissible under applicable 
     law.
       ``(6) Provider.--The term `provider' means--
       ``(A) an individual or entity licensed or otherwise 
     authorized under State law to provide health care services, 
     including--
       ``(i) a hospital, nursing facility, comprehensive 
     outpatient rehabilitation facility, home health agency, and 
     hospice program;
       ``(ii) a physician, physician assistant, nurse 
     practitioner, clinical nurse specialist, certified nurse 
     midwife, nurse anesthetist, psychologist, certified social 
     worker, registered dietitian or nutrition professional, 
     physical or occupational therapist, or other individual 
     health care practitioner;
       ``(iii) a pharmacist; and
       ``(iv) a renal dialysis facility, ambulatory surgical 
     center, pharmacy, physician or health care practitioner's 
     office, long-term care facility, behavioral health 
     residential treatment facility, clinical laboratory, or 
     community health center; or
       ``(B) any other person or entity specified in regulations 
     by the Secretary after public notice and comment.

     ``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.

       ``(a) Privilege.--Notwithstanding any other provision of 
     law and subject to subsection (c), patient safety work 
     product shall not be--
       ``(1) subject to a civil or administrative subpoena or 
     order;
       ``(2) subject to discovery in connection with a civil or 
     administrative proceeding;
       ``(3) subject to disclosure pursuant to section 552 of 
     title 5, United States Code (commonly known as the Freedom of 
     Information Act), or any other similar Federal or State law;
       ``(4) required to be admitted as evidence or otherwise 
     disclosed in any State or Federal civil or administrative 
     proceeding; or
       ``(5) 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--
       ``(A) used by a national accreditation organization in an 
     accreditation action against the provider that reported the 
     information;
       ``(B) shared by such organization with its survey team; or
       ``(C) required as a condition of accreditation by a 
     national accreditation association.
       ``(b) Reporter Protection.--
       ``(1) In general.--A provider may not use against an 
     individual in an adverse employment action described in 
     paragraph (2) the fact that the individual in good faith 
     reported information--
       ``(A) to the provider with the intention of having the 
     information reported to a patient safety organization; or
       ``(B) directly to a patient safety organization.
       ``(2) Adverse employment action.--For purposes of this 
     subsection, an `adverse employment action' includes--
       ``(A) the failure to promote an individual or provide any 
     other employment-related benefit for which the individual 
     would otherwise be eligible;
       ``(B) an adverse evaluation or decision made in relation to 
     accreditation, certification, credentialing, or licensing of 
     the individual; and
       ``(C) a personnel action that is adverse to the individual 
     concerned.
       ``(3) Remedies.--Any provider that violates this subsection 
     shall be subject to a civil monetary penalty of not more than 
     $20,000 for each such violation involved. Such penalty shall 
     be imposed and collected in the same manner as civil money 
     penalties under subsection (a) of section 1128A of the Social 
     Security Act are imposed and collected.
       ``(c) Disclosures.--Nothing in this section prohibits any 
     of the following disclosures:
       ``(1) Voluntary disclosure of nonidentifiable information.
       ``(2) Voluntary disclosure of identifiable information by a 
     provider or patient safety organization, if such disclosure--
       ``(A) is authorized by the provider for the purposes of 
     improving quality and safety;
       ``(B) is to an entity or person subject to the requirements 
     of section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
     2033), or any regulation promulgated under such section; and
       ``(C) is not in conflict with such section or any 
     regulation promulgated under such section.
       ``(3) Disclosure as required by law by a provider to the 
     Food and Drug Administration, or on a voluntary basis by a 
     provider to a federally established patient safety program, 
     with respect to an Administration-regulated product or 
     activity for which that entity has responsibility, for the 
     purposes of activities related to the quality, safety, or 
     effectiveness of such Administration-regulated product or 
     activity.
       ``(4) Disclosures of patient safety work product in 
     accordance with this part by a provider to a patient safety 
     organization.
       ``(d) Effect of Transfer, Disclosure.--The following shall 
     not be treated as a waiver of any privilege or protection 
     established under this part:
       ``(1) The transfer of any patient safety work product 
     between a provider and a patient safety organization.
       ``(2) Disclosure of patient safety work product as 
     described in subsection (c).
       ``(3) The unauthorized disclosure of patient safety work 
     product.
       ``(e) Penalty.--
       ``(1) Prohibition.--Except as provided in this part, and 
     subject to paragraphs (2) and (4), it shall be unlawful for 
     any person to disclose patient safety work product in 
     violation of this section, if such disclosure constitutes a 
     negligent or knowing breach of confidentiality.
       ``(2) Relation to hipaa.--The penalty under paragraph (3) 
     for a disclosure in violation of paragraph (1) does not apply 
     if the person would be subject to a penalty under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 (Public Law 104-191; 110 Stat. 2033), or any 
     regulation promulgated under such section, for the same 
     disclosure.
       ``(3) Amount.--Any person who violates paragraph (1) shall 
     be subject to a civil monetary penalty of not more than 
     $10,000 for each such violation involved. Such penalty shall 
     be imposed and collected in the same manner as civil money 
     penalties under subsection (a) of section 1128A of the Social 
     Security Act are imposed and collected.
       ``(4) Subsequent disclosure.--Paragraph (1) applies only to 
     the first person that breaches confidentiality with respect 
     to particular patient safety work product.
       ``(f) Relation to HIPAA.--
       ``(1) In general.--For purposes of applying the regulations 
     promulgated pursuant to section 264(c) of the Health 
     Insurance Portability and Accountability Act of 1996 (Public 
     Law 104-191; 110 Stat. 2033)--
       ``(A) patient safety organizations shall be treated as 
     business associates; and
       ``(B) activities of such organizations described in section 
     921(4) in relation to a provider are deemed to be health care 
     operations (as defined in such regulations) of the provider.

[[Page 5986]]

       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to alter or affect the implementation of such 
     regulations or such section 264(c).
       ``(g) No Limitation of Other Privileges.--Nothing in this 
     section shall be construed to affect privileges, including 
     peer review and confidentiality protections, that are 
     otherwise available under Federal or State laws.
       ``(h) No Limitation on Contracts.--Nothing in this section 
     shall be construed to limit the power of a provider and a 
     patient safety organization, or a patient safety organization 
     and the Agency or any National Patient Safety Database, 
     consistent with the provisions of this Act and other 
     applicable law, to enter into a contract requiring greater 
     confidentiality or delegating authority to make an authorized 
     disclosure.
       ``(i) Relation to State Reporting Requirements.--Nothing in 
     this part shall be construed as preempting or otherwise 
     affecting any State law requiring a provider to report 
     information, including information described in section 
     921(5)(B), that is not patient safety work product.
       ``(j) Continuation of Privilege.--Patient safety work 
     product of an organization that is certified as a patient 
     safety organization shall continue to be privileged and 
     confidential, in accordance with this section, if the 
     organization's certification is terminated or revoked or if 
     the organization otherwise ceases to qualify as a patient 
     safety organization.
       ``(k) Reports on Strategies To Improve Patient Safety.--
       ``(1) Draft report.--Not later than the date that is 18 
     months after any National Patient Safety Database is 
     operational, the Secretary, in consultation with the 
     Director, shall prepare a draft report on effective 
     strategies for reducing medical errors and increasing patient 
     safety. The draft report shall include any measure determined 
     appropriate by the Secretary to encourage the appropriate use 
     of such strategies, including use in any federally funded 
     programs. The Secretary shall make the draft report available 
     for public comment and submit the draft report to the 
     Institute of Medicine for review.
       ``(2) Final report.--Not later than 1 year after the date 
     described in paragraph (1), the Secretary shall submit a 
     final report to the Congress that includes, in an appendix, 
     any findings by the Institute of Medicine concerning research 
     on the strategies discussed in the draft report and any 
     modifications made by the Secretary based on such findings.

     ``SEC. 923. NATIONAL PATIENT SAFETY DATABASE.

       ``(a) Authority.--
       ``(1) In general.--In conducting activities under this 
     part, the Secretary shall provide for the establishment and 
     maintenance of a database to receive relevant nonidentifiable 
     patient safety work product, and may designate entities to 
     collect relevant nonidentifiable patient safety work product 
     that is voluntarily reported by patient safety organizations 
     upon the request of the Secretary. Any database established 
     or designated under this paragraph may be referred to as a 
     `National Patient Safety Database'.
       ``(2) Use of information.--Information reported to any 
     National Patient Safety Database shall be used to analyze 
     national and regional statistics, including trends and 
     patterns of health care errors. The information resulting 
     from such analyses may be included in the annual quality 
     reports prepared under section 913(b)(2).
       ``(3) Advisory role.--The Secretary shall provide 
     scientific support to patient safety organizations, including 
     the dissemination of methodologies and evidence-based 
     information related to root causes and quality improvement.
       ``(b) Standards.--In establishing or designating a database 
     under subsection (a)(1), the Secretary shall, in consultation 
     with representatives of patient safety organizations, the 
     provider community, and the health information technology 
     industry, determine common formats for the voluntary 
     reporting of nonidentifiable patient safety work product, 
     including necessary elements, common and consistent 
     definitions, and a standardized computer interface for the 
     processing of the work product. To the extent practicable, 
     such standards shall be consistent with the administrative 
     simplification provisions of part C of title XI of the Social 
     Security Act.
       ``(c) Certain Methodologies for Collection.--The Secretary 
     shall ensure that the methodologies for the collection of 
     nonidentifiable patient safety work product for any National 
     Patient Safety Database include the methodologies developed 
     or recommended by the Patient Safety Task Force of the 
     Department of Health and Human Services.
       ``(d) Facilitation of Information Exchange.--To the extent 
     practicable, the Secretary may facilitate the direct link of 
     information between providers and patient safety 
     organizations and between patient safety organizations and 
     any National Patient Safety Database.
       ``(e) Restriction on Transfer.--Only nonidentifiable 
     information may be transferred to any National Patient Safety 
     Database.

     ``SEC. 924. TECHNICAL ASSISTANCE.

       ``(a) In General.--The Secretary, acting through the 
     Director, may--
       ``(1) provide technical assistance to patient safety 
     organizations, and to States with reporting systems for 
     health care errors; and
       ``(2) provide guidance on the type of data to be 
     voluntarily submitted to any National Patient Safety 
     Database.
       ``(b) Annual Meetings.--Assistance provided under 
     subsection (a) may include annual meetings for patient safety 
     organizations to discuss methodology, communication, 
     information collection, or privacy concerns.

     ``SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.

       ``(a) In General.--Not later than 6 months after the date 
     of enactment of the Patient Safety and Quality Improvement 
     Act, the Secretary shall establish a process for certifying 
     patient safety organizations.
       ``(b) Process.--The process established under subsection 
     (a) shall include the following:
       ``(1) Certification of patient safety organizations by the 
     Secretary or by such other national or State governmental 
     organizations as the Secretary determines appropriate.
       ``(2) If the Secretary allows other governmental 
     organizations to certify patient safety organizations under 
     paragraph (1), the Secretary shall establish a process for 
     approving such organizations. Any such approved organization 
     shall conduct certifications and reviews in accordance with 
     this section.
       ``(3) A review of each certification under paragraph (1) 
     (including a review of compliance with each criterion in this 
     section and any related implementing standards as determined 
     by the Secretary through rulemaking) not less often than 
     every 3 years, as determined by the Secretary.
       ``(4) Revocation of any such certification by the Secretary 
     or other such governmental organization that issued the 
     certification, upon a showing of cause.
       ``(c) Criteria.--A patient safety organization must meet 
     the following criteria as conditions of certification:
       ``(1) The mission of the patient safety organization is to 
     conduct activities that are to improve patient safety and the 
     quality of health care delivery and is not in conflict of 
     interest with the providers that contract with the patient 
     safety organization.
       ``(2) The patient safety organization has appropriately 
     qualified staff, including licensed or certified medical 
     professionals.
       ``(3) The patient safety organization, within any 2 year 
     period, contracts with more than 1 provider for the purpose 
     of receiving and reviewing patient safety work product.
       ``(4) The patient safety organization is not a component of 
     a health insurer or other entity that offers a group health 
     plan or health insurance coverage.
       ``(5) The patient safety organization is managed, 
     controlled, and operated independently from any provider that 
     contracts with the patient safety organization for reporting 
     patient safety work product.
       ``(6) To the extent practical and appropriate, the patient 
     safety organization collects patient safety work product from 
     providers in a standardized manner that permits valid 
     comparisons of similar cases among similar providers.
       ``(d) Additional Criteria for Component Organizations.--If 
     a patient safety organization is a component of another 
     organization, the patient safety organization must, in 
     addition to meeting the criteria described in subsection (c), 
     meet the following criteria as conditions of certification:
       ``(1) The patient safety organization maintains patient 
     safety work product separately from the rest of the 
     organization, and establishes appropriate security measures 
     to maintain the confidentiality of the patient safety work 
     product.
       ``(2) The patient safety organization does not make an 
     unauthorized disclosure under this Act of patient safety work 
     product to the rest of the organization in breach of 
     confidentiality.
       ``(3) The mission of the patient safety organization does 
     not create a conflict of interest with the rest of the 
     organization.''.
       (b) Authorization of Appropriations.--Section 937 of the 
     Public Health Service Act (as redesignated by subsection (a)) 
     is amended by adding at the end the following:
       ``(e) Patient Safety and Quality Improvement.--For the 
     purpose of carrying out part C, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2004 through 2008.''.

     SEC. 102. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF 
                   INFORMATION TECHNOLOGY SYSTEMS INVOLVED WITH 
                   HEALTH CARE DELIVERY.

       (a) Voluntary Standards.--
       (1) In general.--Not later than 18 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary'') 
     shall--
       (A) develop or adopt voluntary national standards that 
     promote the interoperability of information technology 
     systems involved with health care delivery, including but not 
     limited to computerized physician order entry;
       (B) in developing or adopting such standards, take into 
     account--

[[Page 5987]]

       (i) the ability of such systems to capture and aggregate 
     clinically specific data to enable evidence-based medicine 
     and other applications that promote the electronic exchange 
     of patient medical record information; and
       (ii) the cost that meeting such standards would have on 
     providing health care in the United States and the increased 
     efficiencies in providing such care achieved under the 
     standards;
       (C) in developing or adopting such standards and to the 
     extent practicable, test the efficacy, usability, and 
     scalability of proposed interoperability standards within a 
     variety of clinical settings, including an urban academic 
     medical center, a rural hospital, a community health center, 
     and a community hospital; and
       (D) submit a report to the Congress containing 
     recommendations on such standards.
       (2) Consultation.--In developing or adopting standards 
     under paragraph (1)(A), the Secretary shall consider the 
     recommendations of the National Committee on Vital Health 
     Statistics for the standardization of message formatting, 
     coding, and vocabulary for interoperability of information 
     technology systems involved with health care delivery. The 
     Secretary shall consult with representatives of the health 
     information technology industry and the provider community 
     who are involved with the development of interoperability 
     standards.
       (b) Updates.--The Secretary shall provide for the ongoing 
     review and periodic updating of the standards developed under 
     subsection (a).

     SEC. 103. REQUIRED USE OF PRODUCT IDENTIFICATION TECHNOLOGY.

       The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.) is amended--
       (1) in section 502, by adding at the end the following:
       ``(w) If it is a drug or biological product, unless it 
     includes a unique product identifier for the drug or 
     biological product as required by regulations under section 
     510(q).''; and
       (2) in section 510, by adding at the end the following:
       ``(q)(1) The Secretary shall issue, and may 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 a drug 
     or biological product that is subject to regulation by the 
     Food and Drug Administration, to include a unique product 
     identifier on the packaging of the drug or biological 
     product.
       ``(2) For purposes of this subsection, the term `unique 
     product identifier' means an identification that--
       ``(A) is affixed by the manufacturer, labeler, or packager 
     to each drug or biological product described in paragraph (1) 
     at each packaging level;
       ``(B) uniquely identifies the item and meets the standards 
     required by this section; and
       ``(C) can be read by a scanning device or other technology 
     acceptable to the Secretary.
       ``(3) A unique product identifier required by regulations 
     issued or revised under paragraph (1) shall be based on--
       ``(A) the National Drug Code maintained by the Food and 
     Drug Administration;
       ``(B) commercially accepted standards established by 
     organizations that are accredited by the American National 
     Standards Institute, such as the Health Industry Business 
     Communication Council or the Uniform Code Council; or
       ``(C) other identification formats that the Secretary deems 
     appropriate.
       ``(4) The Secretary may, at the Secretary's discretion, 
     waive the requirements of this section, or add additional 
     provisions that are necessary to safeguard the public 
     health.''.

     SEC. 104. GRANTS FOR ELECTRONIC PRESCRIPTION PROGRAMS.

       (a) Grants.--
       (1) In general.--The Secretary of Health and Human Services 
     (in this section referred to as the ``Secretary'') may make 
     grants to qualified practitioners for the purpose of 
     establishing electronic prescription programs.
       (2) Matching funds.--
       (A) In general.--With respect to the costs of establishing 
     an electronic prescription program, a condition for the 
     receipt of a grant under paragraph (1) is that the qualified 
     practitioner involved agree to make available (directly or 
     through donations from public or private entities) non-
     Federal contributions toward such costs in an amount that is 
     not less than 50 percent of such costs.
       (B) Determination of amount contributed.--Non-Federal 
     contributions required in subparagraph (A) may be in cash or 
     in kind, fairly evaluated, including equipment or services. 
     Amounts provided by the Federal Government, or services 
     assisted or subsidized to any significant extent by the 
     Federal Government, may not be included in determining the 
     amount of such non-Federal contributions.
       (b) Study.--
       (1) In general.--The Secretary, acting through the Director 
     of the Agency for Healthcare Research and Quality, shall 
     support a study to assess existing scientific evidence 
     regarding the effectiveness and cost-effectiveness of the use 
     of electronic prescription programs intended to improve the 
     efficiency of prescription ordering and the safe and 
     effective use of prescription drugs. The study shall address 
     the following:
       (A) The ability of such programs to reduce medical errors 
     and improve the quality and safety of patient care.
       (B) The impact of the use of such programs on physicians, 
     pharmacists, and patients, including such factors as direct 
     and indirect costs, changes in productivity, and 
     satisfaction.
       (C) The effectiveness of strategies for overcoming barriers 
     to the use of electronic prescription programs.
       (2) Report.--The Secretary shall ensure that, not later 
     than 18 months after the date of the enactment of this Act, a 
     report containing the findings of the study under paragraph 
     (1) is submitted to the appropriate committees of the 
     Congress.
       (3) Dissemination of findings.--The Secretary shall 
     disseminate the findings of the study under paragraph (1) to 
     appropriate public and private entities.
       (c) Development of Model.--The Secretary, acting through 
     the Director of the Agency for Healthcare Research and 
     Quality, may develop an Internet-based mathematical model 
     that simulates the cost and effectiveness of electronic 
     prescription programs for qualified practitioners. The model 
     may be designed to allow qualified practitioners to estimate, 
     through an interactive interface, the impact of electronic 
     prescribing on their practices, including the reduction in 
     drug-related health care errors.
       (d) Definitions.--For purposes of this section:
       (1) The term ``electronic prescription program''--
       (A) means a program for the electronic submission and 
     processing of prescriptions; and
       (B) includes the hardware (including computers and other 
     electronic devices) and software programs for the electronic 
     submission of prescriptions to pharmacies, the processing of 
     such submissions by pharmacies, and decision-support 
     programs.
       (2) The term ``qualified practitioner'' means a 
     practitioner licensed by law to administer or dispense 
     prescription drugs.

     SEC. 105. GRANTS TO HOSPITALS AND OTHER HEALTH CARE PROVIDERS 
                   FOR INFORMATION TECHNOLOGIES.

       (a) In General.--The Secretary of Health and Human Services 
     (in this section referred to as the ``Secretary'') shall make 
     grants to hospitals and other health care providers (but not 
     more than 1 grant to any 1 hospital or provider) to pay the 
     costs of acquiring or implementing information technologies 
     whose purposes are--
       (1) to improve quality of care and patient safety; and
       (2) to reduce adverse events and health care complications 
     resulting from medication errors.
       (b) Special Consideration.--In making grants under 
     subsection (a), the Secretary shall give special 
     consideration to applicants who seek to promote the 
     following:
       (1) Interoperability across hospital services or 
     departments using standards developed or adopted by the 
     Secretary under section 102.
       (2) Electronic communication of patient data across the 
     spectrum of health care delivery.
       (3) Computerized physician order entry or bar coding 
     applications.
       (4) Electronic communication of patient data in hospitals 
     that provide services to underserved or low-income 
     populations.
       (5) Improved clinical decisionmaking through acquisition 
     and implementation of decision-support technologies.
       (c) Certain Grant Conditions.--A condition for the receipt 
     of a grant under subsection (a) is that the applicant 
     involved meet the following requirements:
       (1) The applicant agrees to carry out a program to measure, 
     analyze, and report patient safety and medical errors at the 
     hospital or other health care provider involved, to submit to 
     the Secretary a description of the methodology that will be 
     used, and to have such program in effect as soon as 
     practicable after the application for the grant is approved, 
     without regard to whether information technologies under the 
     grant have been implemented.
       (2) The applicant has arranged for an evaluation that 
     addresses the effectiveness and cost-effectiveness of the 
     information technology for which the grant is provided and 
     its impact on the quality and safety of patient care, 
     submitted the evaluation plan to the Secretary, and received 
     approval from the Secretary of the applicant's methodology.
       (3) The applicant has or is developing a patient safety 
     evaluation system (as that term is defined in section 921 of 
     the Public Health Service Act (as amended by section 101)) 
     for reporting health care errors to a patient safety 
     organization.
       (4) The applicant agrees to provide the Secretary with such 
     information as the Secretary may require regarding the use of 
     funds under this program or its impact.
       (5) The applicant provides assurances satisfactory to the 
     Secretary that any information technology planned, acquired, 
     or implemented with grant funds under this section

[[Page 5988]]

     will be part of an information program that--
       (A) carries out the purposes described in subsection (a); 
     and
       (B) is comprehensive or will be expanded to become 
     comprehensive, regardless of whether Federal assistance is 
     available for such expansion.
       (d) Technical Assistance to Grantees.--The Secretary, 
     acting through the Director of the Agency for Healthcare 
     Research and Quality, shall provide technical assistance to 
     applicants and grantees to ensure the appropriate evaluation 
     of the information technologies for which grants are awarded 
     under this section, such as--
       (1) reviewing and providing technical assistance on the 
     applicant's proposed evaluation;
       (2) developing mechanisms to ensure ongoing communications 
     between grantees and evaluators to facilitate the 
     identification and resolution of problems as they arise, 
     ensure mutual learning, and promote the rapid dissemination 
     of information;
       (3) reviewing the interim and final reports required under 
     subsection (e); and
       (4) disseminating evidence-based information in interim and 
     final reports to patient safety organizations, as 
     appropriate.
       (e) Evaluation Reports by Grantee.--A condition for the 
     receipt of a grant under subsection (a) is that the applicant 
     agree to submit an interim and a final report to the 
     Secretary in accordance with this subsection.
       (1) Interim report.--Not later than 1 year after the 
     implementation of information technologies under the grant is 
     completed, the applicant will submit an interim report to the 
     Secretary describing the initial effectiveness of such 
     technologies in carrying out the purposes described in 
     subsection (a).
       (2) Final report.--Not later than 3 years after the 
     implementation of information technologies under the grant is 
     completed, the applicant will submit a final report to the 
     Secretary describing the effectiveness and cost-effectiveness 
     of such technologies and addressing other issues determined 
     to be important in carrying out the purposes described in 
     subsection (a).
       (3) Relation to disbursement of grant.--In disbursing a 
     grant under subsection (a), the Secretary shall withhold \1/
     3\ of the grant until the grantee submits to the Secretary 
     the report required in paragraph (1).
       (f) Reports by Secretary.--
       (1) Interim reports.--
       (A) In general.--Through the fiscal year preceding the 
     fiscal year in which the final report under paragraph (2) is 
     prepared, the Secretary shall submit to the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate periodic reports on the grant program under subsection 
     (a). Such reports shall be submitted not less frequently than 
     once each fiscal year, beginning with fiscal year 2004.
       (B) Contents.--A report under subparagraph (A) shall 
     include information on--
       (i) the number of grants made;
       (ii) the nature of the projects for which funding is 
     provided under the grant program;
       (iii) the geographic distribution of grant recipients; and
       (iv) such other matters as the Secretary determines 
     appropriate.
       (2) Final report.--Not later than 180 days after the date 
     on which the last of the reports is due under subsection 
     (e)(2), the Secretary shall submit a final report to the 
     committees referred to in paragraph (1)(A) on the grant 
     program under subsection (a), together with such 
     recommendations for legislation and administrative action as 
     the Secretary determines appropriate.
       (g) Definitions.--For purposes of this section:
       (1) The term ``costs'', with respect to information 
     technologies referred to in subsection (a), includes total 
     expenditures incurred for--
       (A) purchasing, leasing, and installing computer software 
     and hardware, including hand-held computer technologies;
       (B) making improvements to existing computer software and 
     hardware; and
       (C) purchasing or leasing communications capabilities 
     necessary for clinical data access, storage, and exchange.
       (2) The term ``health care provider'' has the same meaning 
     given to the term ``provider'' in section 921 of the Public 
     Health Services Act (as amended by this Act).
       (h) Termination of Grant Authorities.--The authority of the 
     Secretary to make grants under subsection (a) terminates upon 
     the expiration of fiscal year 2011.
       (i) Matching Funds.--
       (1) In general.--With respect to the costs of a grant to be 
     carried out under this section, such grant may be made only 
     if the applicant agrees to make available (directly or 
     through donations from public or private entities) non-
     Federal contributions toward such costs in an amount that is 
     not less than 50 percent of such costs ($1 for each $1 of 
     Federal funds provided in the grant).
       (2) Determination of amounts contributed.--Amounts provided 
     by the Federal Government, or services assisted or subsidized 
     to any significant extent by the Federal Government, may not 
     be included in determining the amount of such non-Federal 
     contributions.

     SEC. 106. AUTHORIZATION OF APPROPRIATIONS FOR GRANTS UNDER 
                   SECTIONS 104 AND 105.

       For the purpose of carrying out sections 104 and 105, there 
     are authorized to be appropriated $25,000,000 for each of 
     fiscal years 2004 and 2005.

        TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.

     SEC. 201. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.

       Title XI of the Social Security Act is amended by adding at 
     the end the following new section:


            ``medical information technology advisory board

       ``Sec. 1180. (a) Establishment.--
       ``(1) In general.--Not later than 3 months after the date 
     of the enactment of this section, the Secretary shall appoint 
     an advisory board to be known as the `Medical Information 
     Technology Advisory Board' (in this section referred to as 
     the `MITAB').
       ``(2) Chairman.--The Secretary shall designate one member 
     as chairman. The chairman shall be an individual affiliated 
     with an organization having expertise creating American 
     National Standards Institute (ANSI) accepted standards in 
     health care information technology and a member of the 
     National Committee for Vital and Health Statistics.
       ``(b) Composition.--
       ``(1) In general.--The MITAB shall consist of not more than 
     17 members that include--
       ``(A) experts from the fields of medical information, 
     information technology, medical continuous quality 
     improvement, medical records security and privacy, individual 
     and institutional health care clinical providers, health 
     researchers, and health care purchasers;
       ``(B) one or more staff experts from each of the following: 
     the Centers for Medicare & Medicaid Services, the Agency for 
     Healthcare Research and Quality, and the Institute of 
     Medicine of the National Academy of Sciences;
       ``(C) representatives of private organizations with 
     expertise in medical infomatics;
       ``(D) a representative of a teaching hospital; and
       ``(E) one or more representatives of the health care 
     information technology industry.
       ``(2) Terms of appointment.--The term of any appointment 
     under paragraph (1) to the MITAB shall be for the life of the 
     MITAB.
       ``(3) Meetings.--The MITAB shall meet at the call of its 
     chairman or a majority of its members.
       ``(4) Vacancies.--A vacancy on the MITAB shall be filled in 
     the same manner in which the original appointment was made 
     not later than 30 days after the MITAB is given notice of the 
     vacancy and shall not affect the power of the remaining 
     members to execute the duties of the MITAB.
       ``(5) Compensation.--Members of the MITAB shall receive no 
     additional pay, allowances, or benefits by reason of their 
     service on the MITAB.
       ``(6) Expenses.--Each member of the MITAB shall receive 
     travel expenses and per diem in lieu of subsistence in 
     accordance with sections 5702 and 5703 of title 5, United 
     States Code.
       ``(c) Duties.--
       ``(1) In general.--The MITAB shall on an ongoing basis 
     advise, and make recommendations to, the Secretary regarding 
     medical information technology, including the following:
       ``(A) The best current practices in medical information 
     technology.
       ``(B) Methods for the adoption (not later than 2 years 
     after the date of the enactment of this section) of a uniform 
     health care information system interface between and among 
     old and new computer systems.
       ``(C) Recommendations for health care vocabulary, 
     messaging, and other technology standards (including a common 
     lexicon for computer technology) necessary to achieve the 
     interoperability of health care information systems for the 
     purposes described in subparagraph (E).
       ``(D) Methods of implementing--
       ``(i) health care information technology interoperability 
     standardization; and
       ``(ii) records security.
       ``(E) Methods to promote information exchange among health 
     care providers so that long-term compatibility among 
     information systems is maximized, in order to do one or more 
     of the following:
       ``(i) To maximize positive outcomes in clinical care--

       ``(I) by providing decision support for diagnosis and care; 
     and
       ``(II) by assisting in the emergency treatment of a patient 
     presenting at a facility where there is no medical record for 
     the patient.

       ``(ii) To contribute to (and be consistent with) the 
     development of the patient assessment instrument provided for 
     under section 545 of the Medicare, Medicaid, and SCHIP 
     Benefits Improvement and Protection Act of 2000, and to 
     assist in minimizing the need for new and different records 
     as patients move from provider to provider.

[[Page 5989]]

       ``(iii) To reduce or eliminate the need for redundant 
     records, paperwork, and the repetitive taking of patient 
     histories and administering of tests.
       ``(iv) To minimize medical errors, such as administration 
     of contraindicated drugs.
       ``(v) To provide a compatible information technology 
     architecture that facilitates future quality and cost-saving 
     needs and that avoids the financing and development of 
     information technology systems that are not readily 
     compatible.
       ``(2) Reports.--
       ``(A) Initial report.--No later than 18 months after the 
     date of the enactment of this section, the MITAB shall submit 
     to Congress and the Secretary an initial report concerning 
     the matters described in paragraph (1). The report shall 
     include--
       ``(i) the practices described in paragraph (1)(A), 
     including the status of health care information technology 
     standards being developed by private sector and public-
     private groups;
       ``(ii) recommendations for accelerating the development of 
     common health care terminology standards;
       ``(iii) recommendations for completing development of 
     health care information system messaging standards; and
       ``(iv) progress toward meeting the deadline described in 
     paragraph (1)(B) for adoption of methods described in such 
     paragraph.
       ``(B) Subsequent reports.--During each of the 2 years after 
     the year in which the report is submitted under subparagraph 
     (A), the MITAB shall submit to Congress and the Secretary an 
     annual report relating to additional recommendations, best 
     practices, results of information technology improvements, 
     analyses of private sector efforts to implement the 
     interoperability standards established in section 102 of the 
     Patient Safety and Quality Improvement Act, and such other 
     matters as may help ensure the most rapid dissemination of 
     best practices in health care information technology.
       ``(d) Staff and Support Services.--
       ``(1) Executive director.--
       ``(A) Appointment.--The Chairman shall appoint an executive 
     director of the MITAB.
       ``(B) Compensation.--The executive director shall be paid 
     the rate of basic pay for level V of the Executive Schedule.
       ``(2) Staff.--With the approval of the MITAB, the executive 
     director may appoint such personnel as the executive director 
     considers appropriate.
       ``(3) Applicability of civil service laws.--The staff of 
     the MITAB shall be appointed without regard to the provisions 
     of title 5, United States Code, governing appointments in the 
     competitive service, and shall be paid without regard to the 
     provisions of chapter 51 and subchapter III of chapter 53 of 
     such title (relating to classification and General Schedule 
     pay rates).
       ``(4) Experts and consultants.--With the approval of the 
     MITAB, the executive director may procure temporary and 
     intermittent services under section 3109(b) of title 5, 
     United States Code.
       ``(e) Powers.--
       ``(1) Hearings and other activities.--For the purpose of 
     carrying out its duties, the MITAB may hold such hearings and 
     undertake such other activities as the MITAB determines to be 
     necessary to carry out its duties.
       ``(2) Detail of federal employees.--Upon the request of the 
     MITAB, the head of any Federal agency is authorized to 
     detail, without reimbursement, any of the personnel of such 
     agency to the MITAB to assist the MITAB in carrying out its 
     duties. Any such detail shall not interrupt or otherwise 
     affect the civil service status or privileges of the Federal 
     employee.
       ``(3) Technical assistance.--Upon the request of the MITAB, 
     the head of a Federal agency shall provide such technical 
     assistance to the MITAB as the MITAB determines to be 
     necessary to carry out its duties.
       ``(4) Obtaining information.--The MITAB may secure directly 
     from any Federal agency information necessary to enable it to 
     carry out its duties, if the information may be disclosed 
     under section 552 of title 5, United States Code. Upon 
     request of the Chairman of the MITAB, the head of such agency 
     shall furnish such information to the MITAB.
       ``(f) Termination.--The MITAB shall terminate 30 days after 
     the date of submission of its final report under subsection 
     (c)(2)(B).
       ``(g) Applicability of FACA.--The provisions of the Federal 
     Advisory Committee Act (5 U.S.C. App.) shall apply to the 
     MITAB.
       ``(h) Funding.--There are authorized to be appropriated 
     such sums as are necessary for each fiscal year to carry out 
     this section.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Florida (Mr. Bilirakis) and the gentleman from Louisiana (Mr. John) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Florida (Mr. Bilirakis).


                             General Leave

  Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and to insert extraneous material on H.R. 663, the legislation 
under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Florida?
  There was no objection.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I first commend the leadership of the gentleman from 
Louisiana (Mr. Tauzin), chairman of the Committee on Energy and 
Commerce, and the gentleman from Ohio (Mr. Brown) and the gentleman 
from Michigan (Mr. Dingell), minority leaders on that committee, and 
the gentleman from California (Mr. Thomas), chairman of the Committee 
on Ways and Means, and the gentlewoman from Connecticut (Mrs. Johnson), 
the subcommittee chairman of the Committee on Ways and Means, in 
helping us bring forward this important bipartisan legislation.
  Mr. Speaker, I rise in strong support of the bill. This is a 
critically important bill which we refer to as the Patient Safety and 
Quality Improvement Act, and I look forward to its favorable 
consideration by the House today.
  I know most Members are well acquainted with the disturbing frequency 
and devastating impact of medical errors. Unfortunately, recent events 
have once again attached a human face to the horrible reality that, 
sometimes, even the best health care professionals make mistakes.
  The work of the Institute of Medicine in this area helped increase 
the public's focus on this problem, as well as potential solutions. One 
of the many recommendations that the IOM made in its 1999 report, which 
they called ``To Err Is Human,'' was that Congress should enact laws to 
protect the confidentiality of information collected as part of a 
voluntary medical error reporting system. That IOM recommendation 
represents the foundation of the Patient Safety and Quality Improvement 
Act.
  Specifically, H.R. 663 defines a new voluntary medical error 
reporting system whereby the Secretary of Health and Human Services 
will certify a number of private and public organizations to act as 
patient safety organizations, PSOs. These patient safety organizations 
will analyze data on medical errors, determine their causes, and 
develop and disseminate evidence-based information to providers to help 
them implement changes that will improve patient safety. H.R. 663 
provides peer review protections to the documents and communications 
providers will submit to patient safety organizations, which we hope 
will encourage the exchange of this important information.
  Mr. Speaker, I believe the bill will help us move from a ``culture of 
blame'' to a ``culture of safety'' and ultimately increase patient 
safety. The Patient Safety and Quality Improvement Act is the product 
of excellent, bipartisan work. I urge Members to join me in supporting 
it today.
  Mr. Speaker, I reserve the balance of my time.
  Mr. JOHN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 663, the Patient Safety and 
Quality Improvement Act. This bill is a product of bipartisan 
negotiations between not only the Committee on Energy and Commerce but 
also includes key members from both sides of the aisle on the Committee 
on Ways and Means; and I thank Members on both sides of the aisle for 
their very hard work on this important piece of legislation.

                              {time}  1315

  It has been more than 3 years since the Institute of Medicine 
released the landmark study, ``To Err Is Human.'' The Institute of 
Medicine stated that our health care system is plagued with an epidemic 
of medical errors. However, many of these mistakes could be prevented 
in the health care delivery system and the way that it is delivered.
  With this bill, Congress is taking an important step towards reducing 
medical errors. The Patient Safety and Quality Improvement Act creates 
a voluntary reporting system that will enable providers to learn from 
past mistakes. Providers could report information about medical errors 
to patient

[[Page 5990]]

safety organizations who would analyze the data in confidence and 
recommend strategies to prevent future errors. These organizations 
could share knowledge with each other and with the Agency for Health 
Care Research and Quality so that all actors in the health care system 
could benefit.
  Congress intends for providers to take these lessons learned and 
modify their operations to keep their patients safer. This bill 
requires the Secretary of Health and Human Services to recommend which 
strategies for reducing medical errors would be appropriate standards 
for providers in Federal health care programs. No bill can prevent all 
medical errors, but it is our hope that this legislation will result in 
real differences that patients can see.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to 
the gentleman from Louisiana (Mr. Tauzin), the chairman of the full 
committee, who is more responsible for this piece of legislation than 
any of us.
  Mr. TAUZIN. Mr. Speaker, actually I rise first to commend a Member of 
the House who has done some extraordinary work, not even on our 
committee but on the Committee on Ways and Means, and that is the 
gentlewoman from Connecticut (Mrs. Johnson), who has really contributed 
mightily to the understanding of this issue and has helped indeed frame 
much of the solutions that this bill contains. I want to thank the 
gentlewoman from Connecticut (Mrs. Johnson) and the gentleman from 
California (Mr. Thomas) of the Committee on Ways and Means for that 
vital process. I particularly also want to thank the gentleman from 
Florida (Mr. Bilirakis), the chairman of the Subcommittee on Health, 
and the gentleman from Ohio (Mr. Brown) and the gentleman from Michigan 
(Mr. Dingell), the ranking members of the subcommittee and the full 
committee, indeed for the fact that this is a bipartisan effort to do 
something about medical errors which end up creating victims of a 
health care system who should never have to suffer because of those 
errors.
  We are told in the project of 1999 that was done by the Institute of 
Medicine, in that report entitled ``To Err Is Human,'' that as many as 
98,000 people in this country die as a result of medical errors. In 
fact, the news contains the story today of perhaps some errors in a 
young child who received an organ transplant just this week again. 
Those awful stories should come to an end. The first and most important 
way of ending medical error damage and death in our health care system 
is in fact to do what we are doing today, and that is to set up a 
system whereby health care officials and doctors and nurses, clinics 
and hospitals, can share information. One can learn from the other.
  The impediments to sharing information today are many. The ability of 
a doctor to share information about something that went wrong or a 
hospital to share information with another hospital about something 
that could go right in the case of a medical error prevented, those 
inabilities are corrected in this act. The act creates not only the 
incentive for information sharing but grants an assistance for the 
technologies that are going to improve the transfer of information that 
will make less error in the health care system a reality and, 
therefore, again save human lives and human misery.
  This act will not only improve the quality of our health care system, 
it will immeasurably improve the safety of the health care facilities 
and the safety net that surrounds someone who goes into one of those 
facilities expecting to be healed rather than to come out with an 
infection.
  As the chairman of the Subcommittee on Health said, the effort here 
is to create a culture of safety by providing a legal protection 
framework for the information that is reported, that is provided, about 
quality improvement and patient safety. The thrust is to provide the 
opportunity for health care providers to submit information to a 
patient safety organization and have an analysis done so that we can 
learn from all the information coming in, what works, what does not 
work, what errors are occurring and why they are occurring, and then to 
have these same organizations have the benefit of that information in 
preventing those errors and in improving the safety of their 
procedures.
  There are several provisions aimed at improving the diffusion and 
functioning of important information technologies that help prevent 
medical errors. This legislation is not the only one we will work on to 
help improve patient safety and quality. There are other efforts being 
undertaken in the States and in the local medical communities of all of 
our homes. We want to support those efforts as well and will continue 
to work in a bipartisan fashion as we have done here to help improve 
the outcomes in our health care system.
  In short, today we begin a very aggressive campaign to root out 
errors within the health care delivery system and to save lives and 
injury that result from those errors. Tomorrow we will take up the 
liability questions, the questions of how liability and malpractice 
cases are pursued in this country. But today we focus on this set of 
victims as our committee continues to put patients first, as we try to 
focus all our health care policy and decision-making on how we can 
better help patients receive good, quality, safe health care when they 
go to a health care facility in this country or they seek the services 
of a health care provider.
  This is extremely important stuff we do today. I hope this House 
understands that while this is a bipartisan effort, while it passed 
committee on a voice vote, while we are all very supportive of it and 
very grateful for the work of not only the members of our committee but 
other committees who have assisted us, I want everyone to know that 
this is really serious stuff. If this works, we could save nearly 
100,000 American citizens who die yearly from these errors. This is 
important stuff. I urge the House to agree with this important 
legislation.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as she may consume to 
the gentlewoman from New York (Mrs. Kelly).
  Mrs. KELLY. Mr. Speaker, I rise today in strong support of the 
Patient Safety and Quality Improvement Act, legislation which will 
strengthen our health care system and improve patient care. Today we 
are considering a bill that creates a structured process for reporting 
errors made during the course of medical treatment. Voluntary and 
confidential disclosure can help reduce injuries and death due to 
medical errors. What we have here is the creation of patient safety 
organizations that are created to conduct comprehensive analyses of 
what went wrong following a medical mistake. The people who provide 
health care are given feedback that way so that they can make changes 
and prevent future occurrences. Compiling this information in a central 
database will allow providers nationwide to benefit from lessons 
learned.
  The simple message is that we need to learn from our mistakes. For 
this legislation to be effective, it is essential that practitioners 
feel comfortable in coming forward with information. I met with a group 
of doctors and providers in my district and they suggested strongly 
that we encourage some kind of indemnification so that they could 
report accurate figures. I am glad to report that this bill contains 
strong legal protections and provisions to ensure that information 
reported is treated as confidential, such as whistleblower-type 
protections. I think that is a very good piece in this bill. Creating a 
culture of safety surrounding the reporting of medical errors will 
encourage health care practitioners to report these mistakes.
  The Institute of Medicine reported in 1999 that medical errors are 
the eighth leading cause of death among Americans. I believe this bill 
will go a long way toward preventing many of these tragic deaths and 
injuries. Mr. Speaker, the bill makes great sense for patients and for 
health care providers. I applaud the committee for putting this bill 
forward, and I urge my colleagues to support this legislation.
  Mr. STARK. Mr. Speaker, reducing medical errors is an important goal, 
and this legislation

[[Page 5991]]

takes a small step in that direction. But don't be fooled by the 
rhetoric.
  While the legislation offers a glimmer of hope that action will be 
taken, it does nothing to actually prevent any future medical errors or 
improve patient safety.
  Unfortunately, the timing of the consideration of this bill is driven 
by crass political motives to provide cover for the anti-patient 
legislation that will be considered tomorrow.
  I personally think one of our goals should be to first do no harm, 
and I believe this bill accomplishes that. But it doesn't do much good 
either.
  Federal agencies, states, and the private sector are making strides 
in this area. But there are certain things that only Congress can do. 
The legislation before us is not the best example of what that role 
should be.
  This legislation reflects a tenuously and delicately crafted 
compromise that assures that information which is discoverable today 
will remain discoverable if this bill becomes law. While the bill 
creates a new federal privilege for the data created for this new 
voluntary reporting system, it does not erode a patient's right to 
access information that is currently available and would be available 
but for this new system. I am satisfied that--as currently written--it 
seems to accomplish that goal. But I am concerned about how it will be 
used and intend to keep an eye on it.
  The bill establishes a voluntary system under which patient safety 
organizations may be created, providers may report their mistakes and 
the Secretary may act to improve patient safety practices.
  But let's talk about what this bill does not do.
  It does not reflect the Institute of Medicine's recommendations from 
the landmark 1999 report.
  It does not ensure that providers change their practices to prevent 
medical errors, based on the insight that might be gained from the 
system created under this bill.
  It does not require a rigorous evaluation of this new voluntary 
system, which may be ineffective.
  The IOM report estimated that as many as 98,000 hospital deaths each 
year may be attributable to preventable medical errors, yet this 
legislation fails to assure any reduction in this tragic statistic. It 
certainly doesn't address the recent organ transplant tragedies.
  There are a number of steps that can be taken today to reduce errors 
and improve patient safety, but too few providers have implemented 
these policies.
  For example, only one percent of hospitals require use of 
computerized order-entry systems to reduce pharmaceutical prescribing, 
dispensing and administration errors.
  Similarly, last year the American Nurses Association testified that a 
significant portion of hospital errors are the result of fatigued and 
overworked staff. Around the country, nurses are regularly forced to 
work more hours than are believed to be safe to provide quality care. I 
introduced legislation (H.R. 745) to prohibit this unsafe practice.
  Without assurances that the system will use this newly protected data 
to improve practice, this lop-sided exercise benefits the providers at 
the expense of patients, and the trade-off may not be worth it.
  Finally, let's not forget that the timing of this legislation is not 
accidental. This legislation is being brought up today in an effort to 
distract from the anti-patient legislation that Congress will take up 
tomorrow. Don't be fooled by the rhetoric.
  I intend to vote for this bill because it does no harm and lays the 
groundwork for future action. But we have missed an opportunity to do 
more.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 663, the 
``Patient Safety and Quality Improvement Act.'' This bipartisan bill is 
the product of collaboration with my colleagues on the Committee on 
Energy and Commerce, particularly Chairmen Tauzin and Bilirakis, and 
Subcommittee Ranking Member Brown. I also note that this legislation 
builds on the work of my colleagues on the Committee on Ways and Means, 
including Representatives Johnson, Stark, Thomas, and Rangel. I thank 
all who have made important contributions to this bill.
  The Patient Safety and Quality Improvement Act addresses a problem 
that many of us are familiar with. According to a December 2003 survey 
by the Harvard School of Public Health and the Kaiser Family 
Foundation, 42 percent of the public says that they or a family member 
have experienced a medical error.
  This bill contains one piece of the puzzle that must be completed in 
order to reduce medical errors. It would create a voluntary reporting 
system for the purpose of learning from medical mistakes.
  Under this voluntary reporting system, health care providers could 
report information on medical errors to Patient Safety Organizations. 
These organizations would help providers analyze what went wrong and 
identify what strategies could prevent future mistakes. It is our 
intent that providers would take this knowledge and make changes in the 
health care delivery system to improve care for patients.
  I also hope that the Secretary of Health and Human Services would use 
this knowledge to set some basic guidelines that all providers would be 
required to follow. Patients should be able to expect that providers 
are adhering to certain safety standards before they seek treatment 
from a doctor, hospital, or other facility.
  The best patient safety bill, however, cannot prevent all medical 
errors. Unfortunately, there will be cases where a medical mistake is 
made and a patient suffers injury or death as a result. If medical 
malpractice was involved in these cases, patients and their families 
should be entitled to seek compensation under a fair and accessible 
legal system. It would be disingenuous to suggest that the limited 
legislation before us today could supplant the vital role of legal 
remedies for medical malpractice.
  Again, I thank my colleagues for their cooperation in writing this 
patient safety bill, and I look forward to seeing the improvements that 
will result when it is implemented.
  Mr. ENGEL. Mr. Speaker, HR 663, the Patient Safety and Quality 
Improvement Act, is important legislation that holds great promise to 
reduce medical errors. This legislation will allow medical errors to be 
reported so we can learn from mistakes and hopefully prevent future 
errors from occurring. By allowing errors or near misses to be reported 
anonymously it takes away the fear many providers have in regards to 
reporting errors.
  I am particularly pleased that the legislation creates the Medical 
Information Technology Assessment Board which will work in conjunction 
with the Department of Health and Human Services to develop national 
interoperability standards. I was pleased to work with the Committee to 
get this provision included in the bill. These national standards will 
allow all aspects of health care technology to become compatible. Thus, 
computers, hand held electronic charts and other new devices that hold 
a variety of medical information, including laboratory and radiology 
results, pharmacy orders, etc, will all be compatible. This 
compatibility will greatly reduce medical errors. Further, the 
legislation authorizes grants to test the interoperability standards. 
This is vitally important as it will prove the efficacy, usability, and 
scalability of interoperability standards, thus encouraging hospitals 
and other health care facilities and providers to adopt the standards 
and invest in medical informatics.
  Mr. Speaker, I am proud to be a cosponsor of the Patient Safety and 
Quality Improvement Act, and I thank both the Energy and Commerce and 
Ways and Means Committees for working in a bipartisan fashion to 
produce good legislation on such an important issue.
  Mr. GREEN of Texas. Mr. Speaker, I am pleased to rise in support of 
the Patient Safety and Quality Improvement Act. This important 
legislation takes a number of steps to reduce medical errors.
  In November of 1999, the Institute of Medicine released its 
groundbreaking report, To Err is Human, which raises serious concerns 
about shortcomings in the area of patient safety.
  According to some estimates, as many as 98,000 people die in any 
given year from medical errors that occur in hospitals. That's more 
than die from motor vehicle accidents, breast cancer, or AIDS.
  The costs of preventable adverse events are staggering. The direct 
and indirect costs of medical errors range from $17 billion to $29 
billion. By any standard, that is far too much.
  The Institute of Medicine recommended a number of options to help 
reduce medical errors, such as the creation of a Center for Patient 
Safety within the Agency for Health Quality and Research.
  They also suggested a new system of reporting, and better use of 
technological advancements.
  The legislation we are considering today incorporates many of the 
suggestions made by IOM, and will go a long way to help health care 
providers improve patient safety and prevent medical errors.
  This legislation creates a ``culture of safety'' by encouraging 
providers to report medical mistakes. By reporting these problems, 
physicians and other providers are able to learn from their mistakes 
and prevent them from happening in the future.
  This legislation also permits the Secretary of the Department of 
Health and Human Services to provide to patient safety organizations 
and to States technical assistance with reporting systems for health 
care errors, to establish a process to certify patient safety 
organizations, and to develop or adopt voluntary national standards 
promoting the interoperability

[[Page 5992]]

of information technology systems involved with health care delivery.
  These provisions will go a long way in helping our hospitals and 
physicians offices a safer place. I urge my colleagues to support this 
legislation and hope to see it signed by the President this year.
  Mr. PAUL. Mr. Speaker, it is doubtful that H.R. 663, the Patient 
Safety and Quality Improvement Act, will in fact improve the quality of 
medical care. What is not doubtful is that H.R. 663 will increase the 
federal government's control over medicine, which I believe is the most 
dangerous trend facing medicine today. Under H.R. 663, federally-
empowered boards and commissions will be empowered to establish new 
medical databases on patient errors, develop standards for health care 
information technology systems, and issue new federal standards 
regarding the packaging of drugs and biological products. Supporters of 
this bill will claim that compliance with the standards promulgated is 
voluntary: however, medical administrators will feel pressure to adhere 
to the federal guidelines for no other reason than to avoid 
jeopardizing their federal funding. Furthermore, it is questionable how 
long Congress will allow the standards to remain voluntary. After all, 
if the federal government is using taxpayer dollars to determine the 
best means of protecting patients, than we ``owe'' it to the taxpayer 
to make sure all practitioners are following federal standards!
  Supporters of having the federal government determine the standards 
for patient safety believe that the federal government is capable of 
determining the best ways to enhance patient safety. However, Mr. 
Speaker, it is unlikely that the federal government can effectively 
identify and popularize a definitive list of best practices for a field 
as diverse and rapidly changing as medicine. In fact, by the time such 
standards make their way through what is certain to be a lengthy 
bureaucratic approval process, the standards are likely to be out of 
date! Furthermore, the standards will inevitably reflect the bias of 
those chosen to be on the patient safety boards. However, many 
practitioners will no doubt feel discouraged from adopting medical 
error reduction techniques not on the ``approved government list.'' 
Thus, the main effect of federalizing the process of developing 
standards of patient quality will be to retard the development of those 
standards.
  I am also concerned about the possible violations of privacy that 
inevitably accompany the government collection of medical data. Of 
course, the supporters of this bill claim that the reporting will not 
disclose any personal information. However, even medical systems which 
claim not to collect personal identifiable information can threaten 
privacy. This is because those with access to the information can 
oftentimes identify the subject of the ``anonymous'' report. I am aware 
of at least one incident where a man had his identity revealed when his 
medical records were used without his consent. As a result, many people 
in his community discovered details of his medical history that he 
wished to keep private! Just this morning, CNN's web site reported on 
the poor job federal agencies and government contractors are doing in 
protecting the confidentiality of social security numbers; yet we are 
supposed to trust the government with access to even more personal 
information!
  In conclusion Mr. Speaker, H.R. 663 could actually retard the 
development of innovations in patient safety while promoting yet more 
federal control of health care. In addition, it poses a potential 
threat to medical privacy. Therefore, I urge my colleagues to oppose 
this bill.
  Mr. JOHN. Mr. Speaker, I yield back the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. LaHood). The question is on the motion 
offered by the gentleman from Florida (Mr. Bilirakis) that the House 
suspend the rules and pass the bill, H.R. 663, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. BILIRAKIS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

                          ____________________