[Congressional Record (Bound Edition), Volume 150 (2004), Part 13]
[Senate]
[Pages 17014-17020]
[From the U.S. Government Publishing Office, www.gpo.gov]




           PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2003

  Mr. FRIST. Mr. President, I ask unanimous consent the Senate now 
proceed to consideration of Calendar No. 387, S. 720.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 720) 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.

  There being no objection, the Senate proceeded to consider the bill 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:
  (Strike the part shown in black brackets and insert the part shown in 
italic.)

                                 S. 720

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

     [SECTION 1. SHORT TITLE.

       [This Act may be cited as the ``Patient Safety and Quality 
     Improvement Act''.

     [SEC. 2. FINDINGS AND PURPOSES.

       [(a) Findings.--Congress makes the following findings:
       [(1) In 1999, the Institute of Medicine released a report 
     entitled To Err is Human that described medical errors as the 
     eighth 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) In their report, the Institute of Medicine called on 
     Congress to provide legal protections with respect to 
     information reported for the purposes of quality improvement 
     and patient safety.
       [(4) The Health, Education, Labor, and Pensions Committee 
     of the Senate held 4 hearings in the 106th Congress and 1 
     hearing in the 107th Congress on patient safety where experts 
     in the field supported the recommendation of the Institute of 
     Medicine for congressional action.
       [(5) Myriad public and private patient safety initiatives 
     have begun. The Quality Interagency Coordination Taskforce 
     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.
       [(6) The research on patient safety unequivocally calls for 
     a learning environment, rather than a punitive environment, 
     in order to improve patient safety.
       [(7) Voluntary data gathering systems are more supportive 
     than mandatory systems in creating the learning environment 
     referred to in paragraph (5) as stated in the Institute of 
     Medicine's report.
       [(8) 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.
       [(9) 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.
       [(10) Many organizations currently collecting patient 
     safety data have expressed a need for legal 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.
       [(11) 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.--It is the purpose of this Act to--
       [(1) encourage a culture of safety and quality in the 
     United States health care system by providing for legal 
     protection of information reported voluntarily for the 
     purposes of quality improvement and patient safety; and
       [(2) 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.

     [SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

       [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) Non-identifiable information.--The term `non-
     identifiable information' means information that is presented 
     in a form and manner that prevents the identification of any 
     provider, patient, and the reporter of patient safety data.
       [``(2) Patient safety data.--The term `patient safety data' 
     means--
       [``(A) any data, reports, records, memoranda, analyses, 
     deliberative work, statements, root cause analyses, or 
     quality improvement processes that could result in improved 
     patient safety or health care quality, that are--
       [``(i) collected or developed by a provider for the purpose 
     of reporting to a patient safety organization;
       [``(ii) reported to a patient safety organization for 
     patient safety or quality improvement processes;
       [``(iii) requested by a patient safety organization 
     (including the contents of such request);
       [``(iv) reported to a provider by a patient safety 
     organization;
       [``(v) collected or developed by a patient safety 
     organization; or
       [``(vi) reported among patient safety organizations, after 
     obtaining authorization; or
       [``(B) information related to corrective actions taken in 
     response to patient safety data;
     for the purpose of improving patient safety, health care 
     quality, or health care outcomes.
       [``(3) Patient safety organization.--The term `patient 
     safety organization' means a private or public organization 
     or component thereof that performs the following activities 
     (which are deemed to be necessary for the proper management 
     and administration of such organization or component 
     thereof):
       [``(A) The conduct, as its primary activity, of efforts to 
     improve patient safety and the quality of health care 
     delivery.
       [``(B) The collection and analysis of patient safety data 
     that are voluntarily submitted by a provider.
       [``(C) The development and dissemination of information to 
     providers with respect to

[[Page 17015]]

     improving patient safety, such as recommendations, protocols, 
     or information regarding best practices.
       [``(D) The utilization of patient safety data to carry out 
     activities 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 
     individually identifiable health information.
       [``(F) The provision of appropriate security measures with 
     respect to patient safety data.
       [``(G) The certification to the Agency that the patient 
     safety organization satisfies the criteria of this paragraph 
     for the period in which the organization is carrying out such 
     duties.
       [``(4) Provider.--The term `provider' means--
       [``(A) a provider of services (as defined in section 
     1861(u) of the Social Security Act) and a person furnishing 
     any medical or other health care services (as defined in 
     section 1861(s)(1) and (2) of such Act) through, or under the 
     authority of, such a provider of services;
       [``(B) a physician (as defined in section 1861(r) of such 
     Act);
       [``(C) any other person, including a pharmacist, who is 
     engaged in the delivery of medical or other health services 
     (as defined in section 1861(s)(1) and (2) of such Act) in a 
     State and who is required by State law or regulation to be 
     licensed or certified by the State to engage in the delivery 
     of such services in the State;
       [``(D) a renal dialysis facility, ambulatory surgical 
     center, pharmacy, physician or health care practitioner's 
     office, long term care facility, behavioral health 
     residential treatment facility, or clinical laboratory; or
       [``(E) any other person or entity specified in regulations 
     by the Secretary after public notice and comment.

     [``SEC. 922. CONFIDENTIALITY AND PEER REVIEW PROTECTIONS.

       [``(a) In General.--Notwithstanding any other provision of 
     law, and subject to this section, patient safety data shall 
     be privileged and confidential.
       [``(b) Scope of Privilege.--Subject to the provisions of 
     subsection (c), patient safety data to which subsection (a) 
     applies shall not be--
       [``(1) subject to a civil, criminal, or administrative 
     subpoena;
       [``(2) subject to discovery in connection with a civil, 
     criminal, or administrative proceeding;
       [``(3) disclosed 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) admitted as evidence or otherwise disclosed in any 
     civil, criminal, or administrative proceeding; or
       [``(5) utilized in an adverse employment action or in the 
     evaluation of decisions made in relation to accreditation, 
     certification, credentialing or licensing of an individual, 
     that is based on such individual's participation in the 
     development, collection, reporting, or storage of patient 
     safety data in accordance with this part.
       [``(c) Disclosure Requirements.--Nothing in this section 
     shall be construed to prohibit one or more of the following 
     disclosures (which are deemed to be necessary for the proper 
     management and administration of the patient safety 
     organization):
       [``(1) Disclosures by a provider in complying with 
     authorized requests for the provision of information to which 
     subsection (a) applies (such as a patient's medical record or 
     other relevant information) that is in the control of such a 
     provider and that has been developed, maintained, or exists 
     separately from the process by which the provider collects or 
     develops information for reporting to a patient safety 
     organization.
       [``(2) Disclosures by a provider or patient safety 
     organization of patient safety data as part of a disciplinary 
     proceeding relating to a provider, or a criminal proceeding, 
     if such a disclosure of such patient safety data is--
       [``(A) material to the proceeding;
       [``(B) within the public interest; and
       [``(C) not available from any other source.
       [``(3) Disclosures by a provider or patient safety 
     organization of relevant information to the Food and Drug 
     Administration, or to a person that is subject to the 
     jurisdiction of such Administration, 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, subject to 
     section 520(c) of the Federal Food, Drug, and Cosmetic Act.
       [``(4) Disclosures by a provider or patient safety 
     organization of information to which subsection (a) applies 
     to carry out activities described in paragraph (2)(A) (i) 
     through (vi) or (3) of section 921.
       [``(d) Transfer of Information.--The transfer of any 
     patient safety data by a provider to a patient safety 
     organization shall not be treated as a waiver of any 
     privilege or protection established under this part or 
     established under State law.
       [``(e) Penalty.--Except as provided in subsection (c) and 
     as otherwise provided for in this section, it shall be 
     unlawful for any person to disclose any patient safety data 
     described in subsection (a). Any person violating the 
     provisions of this section shall, upon conviction, be fined 
     in accordance with section 934(d).
       [``(f) No Limitation of Other Privileges.--Nothing in this 
     section shall be construed to limit other privileges that are 
     available under Federal or State laws that provide greater 
     peer review or confidentiality protections than the peer 
     review and confidentiality protections provided for in this 
     section.
       [``(g) Rule of Construction.--Nothing in this section shall 
     be construed to alter or affect the implementation of any 
     provision 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.

     [``SEC. 923. NATIONAL DATABASE.

       [``(a) Authority.--
       [``(1) In general.--In conducting activities under this 
     part, the Secretary may provide for the establishment and 
     maintenance of a database to receive relevant non-
     identifiable patient safety data, or may designate entities 
     to collect relevant non-identifiable patient safety data, 
     that is voluntarily reported by patient safety organizations 
     upon the request of the Secretary.
       [``(2) Use of data.--Data reported to any database 
     established or designated under paragraph (1) shall be used 
     to analyze regional variations and national statistics 
     related to patient safety and health care quality. The 
     information resulting from such analyses may be included in 
     the annual quality reports prepared under section 913(b)(2).
       [``(b) Standards.--In developing or designating a database 
     under subsection (a)(1), the Secretary may determine common 
     formats for the voluntary reporting of non-identifiable 
     patient safety data, including necessary data elements, 
     common and consistent definitions, and a standardized 
     computer interface for the processing of such data. 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) Confidentiality.--Any non-identifiable patient 
     safety data that is transferred to the database under this 
     section shall be privileged and confidential.

     [``SEC. 924. TECHNICAL ASSISTANCE.

       [``The Secretary, acting through the Director, may provide 
     technical assistance to patient safety organizations. Such 
     assistance shall include annual meetings for patient safety 
     organizations to discuss methodology, communication, data 
     collection, or privacy concerns.

     [``SEC. 925. PROMOTING THE INTEGRATION OF HEALTH CARE 
                   INFORMATION TECHNOLOGY SYSTEMS.

       [``(a) Development.--Not later than 36 months after the 
     date of enactment of the Patient Safety and Quality 
     Improvement Act, the Secretary shall develop or adopt 
     voluntary national standards that promote the integration of 
     health care information technology systems.
       [``(b) Updates.--The Secretary shall provide for the 
     ongoing review and periodic updating of the standards 
     developed under subsection (a).
       [``(c) Dissemination.--The Secretary shall provide for the 
     dissemination of the standards developed and updated under 
     this section.

     [``SEC. 926. AUTHORIZATION OF APPROPRIATIONS.

       [``There is authorized to be appropriated such sums as may 
     be necessary to carry out this part.''.

     [SEC. 4. STUDIES AND REPORTS.

       [(a) Medical Technologies and Therapies.--
       [(1) In general.--The Secretary of Health and Human 
     Services shall enter into a contract with an appropriate 
     research organization for the conduct of a study to assess 
     the impact of medical technologies and therapies on patient 
     safety, patient benefit, health care quality, and the costs 
     of care as well as productivity growth. Such study shall 
     determine--
       [(A) the extent to which the current health care system's 
     use of labor versus the use of technology has contributed to 
     increases in the share of the gross domestic product that is 
     devoted to health care and the impact of medical technologies 
     and therapies on such increases;
       [(B) the extent to which early and appropriate introduction 
     and integration of innovative medical technologies and 
     therapies may affect the overall productivity and quality of 
     the health care delivery systems of the United States; and
       [(C) the relationship of such medical technologies and 
     therapies to patient safety, patient benefit, health care 
     quality, and cost of care.
       [(2) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall prepare and submit to the appropriate 
     committees of Congress a report containing the results of the 
     study conducted under paragraph (1).
       [(b) State Laws Relating to Patient Safety Peer Review 
     Systems.--
       [(1) Survey.--The Attorney General shall conduct a survey 
     of State laws that relate to

[[Page 17016]]

     patient safety data peer review systems, including laws that 
     establish an evidentiary privilege applicable to data 
     developed by such systems, and shall review the manner in 
     which such laws have been interpreted by the courts.
       [(2) Report.--Not later than 9 months after the date of 
     enactment of this Act, the Attorney General shall prepare and 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives, a report concerning 
     the results of the survey conducted under paragraph (1).]

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Patient Safety and Quality 
     Improvement Act of 2003''.

     SEC. 2. FINDINGS AND PURPOSES.

       (a) Findings.--Congress makes the following findings:
       (1) In 1999, the Institute of Medicine released a report 
     entitled To Err is Human that described medical errors as the 
     eighth 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) In their report, the Institute of Medicine called on 
     Congress to provide legal protections with respect to 
     information reported for the purposes of quality improvement 
     and patient safety.
       (4) The Health, Education, Labor, and Pensions Committee of 
     the Senate held 4 hearings in the 106th Congress and 1 
     hearing in the 107th Congress on patient safety where experts 
     in the field supported the recommendation of the Institute of 
     Medicine for congressional action.
       (5) Myriad public and private patient safety initiatives 
     have begun. The Quality Interagency Coordination Taskforce 
     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.
       (6) The research on patient safety unequivocally calls for 
     a learning environment, rather than a punitive environment, 
     in order to improve patient safety.
       (7) Voluntary data gathering systems are more supportive 
     than mandatory systems in creating the learning environment 
     referred to in paragraph (6) as stated in the Institute of 
     Medicine's report.
       (8) 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.
       (9) Many organizations currently collecting patient safety 
     data have expressed a need for legal protections that will 
     allow them to review protected information and collaborate in 
     the development and implementation of patient safety 
     improvement strategies. Currently, the State peer review 
     protections are inadequate to allow the sharing of 
     information to promote patient safety.
       (b) Purposes.--It is the purpose of this Act to--
       (1) encourage a culture of safety and quality in the United 
     States health care system by providing for legal protection 
     of information reported voluntarily for the purposes of 
     quality improvement and patient safety; and
       (2) ensure accountability by raising standards and 
     expectations for continuous quality improvements in patient 
     safety.

     SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

       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 934(d) (as so redesignated), by striking the second 
     sentence and inserting the following: ``Penalties provided 
     for under this section shall be imposed and collected by the 
     Secretary using the administrative and procedural processes 
     used to impose and collect civil money penalties under 
     section 1128A of the Social Security Act (other than 
     subsections (a) and (b), the second sentence of subsection 
     (f), and subsections (i), (m), and (n)), unless the Secretary 
     determines that a modification of procedures would be more 
     suitable or reasonable to carry out this subsection and 
     provides for such modification by regulation.'';
       (5) in section 938(1) (as so redesignated), by striking 
     ``921'' and inserting ``931''; and
       (6) by inserting after part B the following:

                  ``PART C--PATIENT SAFETY IMPROVEMENT

     ``SEC. 921. DEFINITIONS.

       ``In this part:
       ``(1) Non-identifiable information.--
       ``(A) In general.--The term `non-identifiable information' 
     means information that is presented in a form and manner that 
     prevents the identification of a provider, a patient, or a 
     reporter of patient safety data.
       ``(B) Identifiability of patient.--For purposes of 
     subparagraph (A), the term `presented in a form and manner 
     that prevents the identification of a patient' means, with 
     respect to information that has been subject to rules 
     promulgated pursuant to section 264(c) of the Health 
     Insurance Portability and Accountability Act of 1996 (42 
     U.S.C. 1320d-2 note), that the information has been de-
     identified so that it is no longer individually identifiable 
     health information as defined in such rules.
       ``(2) Patient safety data.--
       ``(A) In general.--The term `patient safety data' means--
       ``(i) any data, reports, records, memoranda, analyses (such 
     as root cause analyses), or statements that could result in 
     improved patient safety or health care quality or health care 
     outcomes, that are--

       ``(I) collected or developed by a provider for reporting to 
     a patient safety organization, provided that they are 
     reported to the patient safety organization within a 
     reasonable period of time;
       ``(II) requested by a patient safety organization 
     (including the contents of such request);
       ``(III) reported to a provider by a patient safety 
     organization; or
       ``(IV) collected from a provider or patient safety 
     organization or developed by a patient safety organization; 
     or

       ``(ii) any deliberative work or process or oral 
     communications with respect to any patient safety data 
     described in clause (i).
       ``(B) Limitation.--The term `patient safety data' shall not 
     include information (including a patient's medical record) 
     that is collected or developed separately from and that 
     exists separately from patient safety data. Such separate 
     information or a copy thereof submitted to a patient safety 
     organization shall not itself be considered as patient safety 
     data.
       ``(3) Patient safety organization.--The term `patient 
     safety organization' means a private or public organization 
     or component thereof that performs all of the following 
     activities (which are deemed to be necessary for the proper 
     management and administration of such organization or 
     component thereof), and that is currently listed by the 
     Secretary as a patient safety organization pursuant to 
     section 924(c):
       ``(A) The conduct, as its primary activity, of efforts to 
     improve patient safety and the quality of health care 
     delivery.
       ``(B) The collection and analysis of patient safety data 
     that are submitted by more than one provider.
       ``(C) The development and dissemination of information to 
     providers with respect to improving patient safety, such as 
     recommendations, protocols, or information regarding best 
     practices.
       ``(D) The utilization of patient safety data 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 a process to preserve 
     confidentiality with respect to the information that is not 
     non-identifiable.
       ``(F) The provision of appropriate security measures with 
     respect to patient safety data.
       ``(G) The submittal to the Secretary of a certification 
     pursuant to section 924.
       ``(4) Provider.--The term `provider' means--
       ``(A) a person 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, 
     hospice program, renal dialysis facility, ambulatory surgical 
     center, pharmacy, physician or health care practitioner's 
     office, long term care facility, behavior health residential 
     treatment facility, clinical laboratory, or health center; or
       ``(ii) a physician, physician assistant, nurse 
     practitioner, clinical nurse specialist, certified registered 
     nurse anesthetist, certified nurse midwife, psychologist, 
     certified social worker, registered dietitian or nutrition 
     professional, physical or occupational therapist, pharmacist, 
     or other individual health care practitioner; or
       ``(B) any other person specified in regulations promulgated 
     by the Secretary.

     ``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.

       ``(a) Privilege.--Notwithstanding any other provision of 
     Federal, State, or local law, patient safety data shall be 
     privileged and, subject to the provisions of subsection (c), 
     shall not be--
       ``(1) subject to a Federal, State, or local civil, 
     criminal, or administrative subpoena;
       ``(2) subject to discovery in connection with a Federal, 
     State, or local civil, criminal, or administrative 
     proceeding;
       ``(3) disclosed pursuant to section 552 of title 5, United 
     States Code (commonly known as the Freedom of Information 
     Act) or any other similar Federal, State, or local law;
       ``(4) admitted as evidence or otherwise disclosed in any 
     Federal, State, or local civil, criminal, or administrative 
     proceeding; or
       ``(5) utilized in a disciplinary proceeding against a 
     provider.
       ``(b) Confidentiality.--Notwithstanding any other provision 
     of Federal, State, or local law, and subject to the 
     provisions of subsections (c) and (d), patient safety data 
     shall be confidential and shall not be disclosed.
       ``(c) Exceptions to Privilege and Confidentiality.--Nothing 
     in this section shall be construed to prohibit one or more of 
     the following uses or disclosures:
       ``(1) Disclosure by a provider or patient safety 
     organization of relevant patient safety data for use in a 
     criminal proceeding only after a court makes an in camera 
     determination that such patient safety data contains evidence 
     of an intentional act to directly harm the patient.
       ``(2) Voluntary disclosure by a provider or patient safety 
     organization of information to the Food and Drug 
     Administration, or to a person that is subject to the 
     jurisdiction of the Food and Drug Administration, with 
     respect to a Food and Drug Administration-regulated product 
     or activity for which that entity has responsibility, for the 
     purposes of activities related to the quality, safety, or 
     effectiveness of a Food

[[Page 17017]]

     and Drug Administration-regulated product or activity or a 
     Food and Drug Administration proceeding.
       ``(3) Voluntary disclosure of non-identifiable patient 
     safety data by a provider or a patient safety organization.
       ``(4) Voluntary disclosure by a provider of patient safety 
     data to the Centers for Disease Control and Prevention for 
     public health surveillance, investigation, or other public 
     health activities.
       ``(d) Protected Disclosure and Use of Information.--Nothing 
     in this section shall be construed to prohibit one or more of 
     the following uses or disclosures:
       ``(1) Disclosure by a provider or patient safety 
     organization of information to which subsections (a) or (b) 
     applies to carry out activities described in paragraph (2) or 
     (3) of section 921.
       ``(2) Use or disclosure by a provider or patient safety 
     organization of patient safety data in connection with 
     providing treatment, improving patient safety, health care 
     quality or administrative efficiency, or any other customary 
     activity of the provider or in obtaining payment.
       ``(3) Disclosure of patient safety data among patient 
     safety organizations.
       ``(4) Disclosure of patient safety data by a provider or 
     patient safety organization to grantees or contractors 
     carrying out patient safety research, evaluation, or 
     demonstration projects authorized by the Director.
       ``(5) Disclosure of patient safety data by a provider to an 
     accrediting body that accredits that provider.
       ``(e) Continued Protection of Information.--Patient safety 
     data used or disclosed in accordance with subsection (d) 
     shall continue to be privileged and confidential in 
     accordance with subsections (a) and (b) and shall not be 
     disclosed--
       ``(1) by an entity that possessed such information before 
     such use or disclosure; or
       ``(2) by an entity to which the information was disclosed;
     unless such additional disclosure is permitted under 
     subsection (d).
       ``(f) Limitation on Actions.--
       ``(1) Patient safety organizations.--Except as provided in 
     subsection (c), no action may be brought or process served 
     against a patient safety organization to compel disclosure of 
     information collected or developed under this part whether or 
     not such information is patient safety data.
       ``(2) Providers.--An accrediting body shall not take an 
     accrediting action against a provider based on the good faith 
     participation of the provider in the collection, development, 
     reporting, or maintenance of patient safety data in 
     accordance with this part. An accrediting body may not 
     require a provider to reveal its communications with any 
     patient safety organization established in accordance with 
     this part.
       ``(g) Disclosure or Use of Information.--
       ``(1) In general.--Except with respect to the specific 
     patient safety data that is used or disclosed, the disclosure 
     or use of any patient safety data in accordance with 
     subsection (c) or (d) shall not be treated as a waiver of any 
     privilege or protection established under this part.
       ``(2) Inadvertent disclosure or use.--The inadvertent 
     disclosure or use of patient safety data shall not waive any 
     privilege or protection established under this part with 
     respect to such data.
       ``(h) Reporter Protection.--
       ``(1) In general.--A provider may not take an adverse 
     employment action, as described in paragraph (2), against an 
     individual based upon 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) loss of employment, the failure to promote an 
     individual, or the failure to provide any other employment-
     related benefit for which the individual would otherwise be 
     eligible; or
       ``(B) an adverse evaluation or decision made in relation to 
     accreditation, certification, credentialing, or licensing of 
     the individual.
       ``(i) Enforcement.--
       ``(1) Prohibition.--Except as provided in subsections (c) 
     and (d) and as otherwise provided for in this section, it 
     shall be unlawful for any person to negligently or 
     intentionally disclose any patient safety data described in 
     subsection (a) and any such person shall, upon adjudication, 
     be assessed in accordance with section 934(d).
       ``(2) Relation to hipaa.--The penalty provided for under 
     paragraph (1) shall not apply if the defendant would 
     otherwise be subject to a penalty under the regulations 
     promulgated under section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
     note) or under section 1176 of the Social Security Act (42 
     U.S.C. 1320d-5) for the same disclosure.
       ``(3) Equitable relief.--Without limiting remedies 
     available to other parties, a civil action may be brought by 
     any aggrieved individual to enjoin any act or practice that 
     violates subsection (h) and to obtain other appropriate 
     equitable relief (including reinstatement, back pay, and 
     restoration of benefits) to redress such violation.
       ``(4) Actions against state employees.--Notwithstanding 
     subsection (a), with respect to a State employer, the 
     privilege described in such subsection shall not apply to 
     such employer unless the employer consents, in advance, to be 
     subject to a civil action under paragraph (3).
       ``(j) Rule of Construction.--Nothing in this section shall 
     be construed to--
       ``(1) limit other privileges that are available under 
     Federal, State, or local laws that provide greater 
     confidentiality protections or privileges than the privilege 
     and confidentiality protections provided for in this section;
       ``(2) limit, alter, or affect the requirements of Federal, 
     State, or local law pertaining to patient-related data that 
     is not privileged or confidential under this section;
       ``(3) alter or affect the implementation of any provision 
     of section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
     2033), section 1176 of the Social Security Act (42 U.S.C. 
     1320d-5), or any regulation promulgated under such sections;
       ``(4) limit the authority of any provider, patient safety 
     organization, or other person to enter into a contract 
     requiring greater confidentiality or delegating authority to 
     make a disclosure or use in accordance with subsection (c) or 
     (d); and
       ``(5) prohibit a provider from reporting crime to law 
     enforcement authorities.

     ``SEC. 923. PATIENT SAFETY NETWORK OF DATABASES.

       ``(a) In General.--The Secretary shall maintain a patient 
     safety network of databases that provides an interactive 
     evidence-based management resource for providers, patient 
     safety organizations, and other persons. The network of 
     databases shall have the capacity to accept, aggregate, and 
     analyze nonidentifiable patient safety data voluntarily 
     reported by patient safety organizations, providers, or other 
     persons.
       ``(b) Network of Database Standards.--The Secretary may 
     determine common formats for the reporting to the patient 
     safety network of databases maintained under subsection (a) 
     of nonidentifiable patient safety data, including necessary 
     data elements, common and consistent definitions, and a 
     standardized computer interface for the processing of such 
     data. 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.

     ``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND 
                   LISTING.

       ``(a) Certification.--
       ``(1) Initial certification.--Except as provided in 
     paragraph (2), an entity that seeks to be a patient safety 
     organization shall submit an initial certification to the 
     Secretary that the entity intends to perform the activities 
     described in subparagraphs (A) through (F) of section 921(3).
       ``(2) Delayed certification of collection from more than 
     one provider.--An entity that seeks to be a patient safety 
     organization may--
       ``(A) submit an initial certification that it intends to 
     perform the activities described in subparagraph (A) through 
     (F) of section 921(3) other than the activities described in 
     subparagraph (B) of such section; and
       ``(B) within 2 years of submitting the initial 
     certification under subparagraph (A), submit a supplemental 
     certification that it performs the activities described in 
     section 921(3)(B).
       ``(3) Expiration and renewal.--
       ``(A) Expiration.--An initial certification under paragraph 
     (1) or (2)(A) shall expire on the date that is 3 years after 
     it is submitted.
       ``(B) Renewal.--
       ``(i) In general.--An entity that seeks to remain a patient 
     safety organization after the expiration of an initial 
     certification under paragraph (1) or (2)(A) shall, within the 
     3-year period described in subparagraph (A), submit a renewal 
     certification to the Secretary that the entity satisfies the 
     criteria described in subparagraph (A) through (F) of section 
     921(3).
       ``(ii) Term of renewal.--A renewal certification under 
     clause (i) shall expire on the date that is 3 years after 
     that date on which it is submitted, and may be renewed in the 
     same manner as an initial certification.
       ``(b) Acceptance of Certification.--Upon the submission by 
     an organization of an initial certification pursuant to 
     subsection (a)(1) or (a)(2)(A), a supplemental certification 
     pursuant to subsection (a)(2)(B), or a renewal certification 
     pursuant to subsection (a)(3)(B), the Secretary shall review 
     such certification and--
       ``(1) if such certification meets the requirements of 
     subsection (a)(1) or (a)(2)(A), (a)(2)(B), or (a)(3)(B), as 
     applicable, the Secretary shall notify the organization that 
     such certification is accepted; or
       ``(2) if such certification does not meet such 
     requirements, as applicable, the Secretary shall notify the 
     organization that such certification is not accepted and the 
     reasons therefore.
       ``(c) Listing.--
       ``(1) In general.--Except as otherwise provided in this 
     subsection, the Secretary shall compile and maintain a 
     current listing of patient safety organizations with respect 
     to which the Secretary has accepted a certification pursuant 
     to subsection (b).
       ``(2) Removal from listing.--The Secretary shall remove 
     from the listing under paragraph (1)--
       ``(A) an entity with respect to which the Secretary has 
     accepted an initial certification pursuant to subsection 
     (a)(2)(A) and which does not submit a supplemental 
     certification pursuant to subsection (a)(2)(B) that is 
     accepted by the Secretary;
       ``(B) an entity whose certification expires and which does 
     not submit a renewal application that is accepted by the 
     Secretary; and
       ``(C) an entity with respect to which the Secretary revokes 
     the Secretary's acceptance of the entity's certification, 
     pursuant to subsection (d).

[[Page 17018]]

       ``(d) Revocation of Acceptance.--
       ``(1) In general.--Except as provided in paragraph (2), if 
     the Secretary determines that a patient safety organization 
     does not perform any activity described in subparagraph (A) 
     through (F) of section 921(3), the Secretary may, after 
     notice and an opportunity for a hearing, revoke the 
     Secretary's acceptance of the certification of such 
     organization.
       ``(2) Delayed certification of collection from more than 
     one provider.--A revocation under paragraph (1) may not be 
     based on a determination that the organization does not 
     perform the activity described in section 921(3)(B) if--
       ``(A) the listing of the organization is based on its 
     submittal of an initial certification under subsection 
     (a)(2)(A);
       ``(B) the organization has not submitted a supplemental 
     certification under subsection (a)(2)(B); and
       ``(C) the 2-year period described in subsection (a)(2)(B) 
     has not expired.
       ``(e) Notification of Revocation or Removal From Listing.--
       ``(1) Supplying confirmation of notification to 
     providers.--Within 15 days of a revocation under subsection 
     (d)(1), a patient safety organization shall submit to the 
     Secretary a confirmation that the organization has taken all 
     reasonable actions to notify each provider whose patient 
     safety data is collected or analyzed by the organization of 
     such revocation.
       ``(2) Publication.--Upon the revocation of an acceptance of 
     an organization's certification under subsection (d)(1), or 
     upon the removal of an organization from the listing under 
     subsection (c)(2), the Secretary shall publish notice of the 
     revocation or removal in the Federal Register.
       ``(f) Status of Data After Removal From Listing.--
       ``(1) New data.--With respect to the privilege and 
     confidentiality protections described in section 922, data 
     submitted to an organization within 30 days after the 
     organization is removed from the listing under subsection 
     (c)(2) shall have the same status as data submitted while the 
     organization was still listed.
       ``(2) Protection to continue to apply.--If the privilege 
     and confidentiality protections described in section 922 
     applied to data while an organization was listed, or during 
     the 30-day period described in paragraph (1), such 
     protections shall continue to apply to such data after the 
     organization is removed from the listing under subsection 
     (c)(2).
       ``(g) Disposition of Data.--If the Secretary revokes the 
     acceptance of an organization's certification under 
     subsection (d)(1) and removes the organization from the 
     listing as provided for in subsection (c)(2), with respect to 
     the patient safety data that the organization received from 
     providers, the organization shall--
       ``(1) with the approval of the provider and another patient 
     safety organization, transfer such data to such other 
     organization;
       ``(2) return such data to the provider of that patient 
     safety data; or
       ``(3) if returning such data to the provider is not 
     practicable, destroy such data.

     ``SEC. 925. TECHNICAL ASSISTANCE.

       ``The Secretary, acting through the Director, may provide 
     technical assistance to patient safety organizations, 
     including annual meetings for patient safety organizations to 
     discuss methodology, communication, data collection, or 
     privacy concerns.

     ``SEC. 926. PROMOTING THE INTEROPERABILITY OF HEALTH CARE 
                   INFORMATION TECHNOLOGY SYSTEMS.

       ``(a) Development.--Not later than 36 months after the date 
     of enactment of the Patient Safety and Quality Improvement 
     Act of 2003, the Secretary shall develop or adopt voluntary 
     national standards that promote the electronic exchange of 
     health care information.
       ``(b) Updates.--The Secretary shall provide for the ongoing 
     review and periodic updating of the standards developed under 
     subsection (a).
       ``(c) Dissemination.--The Secretary shall provide for the 
     dissemination of the standards developed and updated under 
     this section.

     ``SEC. 927. AUTHORIZATION OF APPROPRIATIONS.

       ``There is authorized to be appropriated such sums as may 
     be necessary to carry out this part.''.

     SEC. 4. STUDIES AND REPORTS.

       (a) In General.--The Secretary of Health and Human Services 
     shall enter into a contract (based upon a competitive 
     contracting process) with an appropriate research 
     organization for the conduct of a study to assess the impact 
     of medical technologies and therapies on patient safety, 
     patient benefit, health care quality, and the costs of care 
     as well as productivity growth. Such study shall examine--
       (1) the extent to which factors, such as the use of labor 
     and technological advances, have contributed to increases in 
     the share of the gross domestic product that is devoted to 
     health care and the impact of medical technologies and 
     therapies on such increases;
       (2) the extent to which early and appropriate introduction 
     and integration of innovative medical technologies and 
     therapies may affect the overall productivity and quality of 
     the health care delivery systems of the United States; and
       (3) the relationship of such medical technologies and 
     therapies to patient safety, patient benefit, health care 
     quality, and cost of care.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall prepare and submit to the appropriate 
     committees of Congress a report containing the results of the 
     study conducted under subsection (a).

  Mr. KENNEDY. Mr. President, I commend Senator Gregg, Senator 
Jeffords, Senator Dodd, Senator Frist, Senator Sessions, and all of the 
other Democratic and Republican members of our Health committee who 
have devoted extraordinary energy and skill to finding bipartisan 
consensus on the complex issue of medical errors and improving patient 
safety.
  For even one American to die from an avoidable medical error is a 
tragedy. That thousands die every year is a national disgrace--and an 
urgent call to action.
  More than 4 years ago, the Institute of Medicine reported that 
medical errors cause 98,000 deaths every year. The IOM recommended that 
health care professionals should be encouraged to report medical 
errors, without fearing that their reports will be used against them. 
Our legislation implements this sensible recommendation by establishing 
patient safety organizations to analyze medical errors and recommend 
ways to avoid them in future. The legislation also creates a legal 
privilege for material reported to these safety organizations, while 
seeing that original records, such as a patient's chart, remain 
accessible to patients.
  Drawing the boundaries of this privilege requires a careful balance. 
The legislation is designed to create a culture in which medical 
professionals feel secure in reporting errors without fear of 
punishment, and it is right to do so. But we must be careful that in 
doing so, we do not actually shield those who have negligently or 
intentionally caused harm to patients. We must also make sure not to 
interfere with existing State laws on reporting.
  The proposal that the Senate considers today has made substantial and 
welcome progress on these and other important issues, and I look 
forward to making further progress in conference with our colleagues in 
the House. I will do all I can to see that we continue the bipartisan 
cooperation that has allowed today's important action. I look forward 
to working with our colleagues in the House to produce a conference 
report that includes the best features of the Senate and House 
proposals. I believe that several features of the bipartisan House 
legislation are worth close consideration by the conference, including 
the strong protections against conflict of interest.
  I hope that this legislation is the beginning of our action on 
patient safety--not the conclusion. Other steps are also necessary. The 
Federal Government should play a leading role in the quest for 
improving quality and safety for patients. Indeed, the very title of 
one of IOM's most important reports, ``Leadership by Example,'' 
highlights the central role that the Federal Government must play in 
transforming the quality of health care.
  I thank all my colleagues from both sides of the aisle, who came 
together and put their differences aside to bring this legislation to 
the floor. This legislation sends a promising message that every 
patient in America will receive effective, high quality health care.
  Mr. JEFFORDS. Mr. President, I am very pleased that today the Senate 
will pass a measure that many have worked on for many years. The 
Patient Safety and Quality Improvement Act, and similar companion 
legislation, have been the focus of considerable efforts by many of our 
colleagues since 1999. I must thank Senator Gregg, Senator Kennedy and 
our other colleagues for all their hard work in bringing S. 720 before 
the Senate today.
  In 1999, Americans were shocked by the findings of the landmark 
Institute of Medicine study on medical errors. As we all know, that 
study reported that the number of deaths associated with medical errors 
could be as high 98,000 each year.
  Most importantly, the report noted that more than half of these 
deaths resulted from preventable errors--needless deaths that could 
have been prevented if we only had a system in place that would help 
providers learn from each other's mistakes.
  The bill starts with a simple premise. Let's set up a system that 
helps our health care providers learn from each other. Let's set up a 
system that promotes the reporting and analysis of

[[Page 17019]]

medical errors. Let's set up a system that engenders the trust of 
providers and the patients they serve.
  Of course, we also live in a complex society, one in which medical 
errors that may have harmed a patient might also be the basis for 
litigation. It is a right under our laws to seek a remedy when harmed, 
and we need to preserve access to certain information for this redress 
of grievances.
  However, an unfortunate consequence of living in a litigious society 
is that hospitals and providers often feel that it's not in their best 
interests to share information openly and honestly. We know, in fact, 
that their attorneys and risk managers often advise them not to do so. 
So, in order for our system to work, it needs to balance these 
sometimes competing demands.
  The bill we are considering strikes this balance. It calls for the 
creation of new entities we call Patient Safety Organizations that 
would collect voluntarily reported patient safety data. This bill 
provides the protections of confidentiality and privilege to that 
patient safety data, but the bill also sets definite limitations on 
what can be considered confidential and privileged.
  This legislation does nothing to reduce or affect other Federal, 
State or local legal requirements pertaining to health related 
information. Nor does this bill alter any existing rights or remedies 
available to injured patients. The bottom line is that this legislation 
neither strengthens nor weakens the existing system of tort and 
liability law.
  Instead, the legislation before us creates a new, parallel system of 
information collection and analysis, designed to educate our doctors 
and protect patients' safety everywhere. This bill reflects difficult 
negotiations and many compromises over almost 5 years of consideration. 
Through the contributions of Members on both sides of the aisle, this 
legislation has been greatly strengthened since I first introduced it 
back in the 106th Congress. I have appended these remarks with an 
article I wrote that provides a more detailed description of the 
efforts that have been made to reduce medical errors and I ask 
unanimous consent that it will be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                           First, Do No Harm

       With the publication of the Institute of Medicine IOM 
     study, To Err is Human 1999, we were all reminded that 
     Hippocrates' maxim to ``first, do no harm'' is as relevant to 
     the practice of medicine today as it was in 400 B.C. The IOM 
     report was among the first to galvanize national attention on 
     the issue of patient safety when it reported that medical 
     errors contribute to approximately 100,000 patient deaths a 
     year. This startling and troubling statistic has been 
     verified in subsequent studies and cited in peer reviewed 
     articles in the leading journals of biomedical research, 
     including the Journal of the American Medical Association, 
     the Lancet, and the New England Journal of Medicine.
       When I was Chairman of the Senate Committee on Health, 
     Education, Labor, and Pensions in 1999, I undertook several 
     hearings--five in all--to examine this issue and discuss the 
     recommendations of the To Err is Human report. The testimony 
     overwhelmingly agreed with several of the original Institute 
     of Medicine recommendations.
       Perhaps the most important of these recommendations stress 
     that improving patient safety requires a learning environment 
     rather than a punitive environment; voluntary data gathering 
     systems as opposed to mandatory systems; and appropriate 
     legal protections--including confidentiality and privilege 
     from discovery--that allow for the review and analysis of 
     medical error information.
       In response to this focused attention, a myriad of public 
     and private patient safety initiatives have begun. The 
     Department of Health and Human Services has initiated several 
     patient safety projects, including project grants funded by 
     the Agency for Healthcare Research and Quality AHRQ. The work 
     of the Veteran's Administration in developing and 
     implementing innovative patient safety systems--especially in 
     the area of medication management--has drawn attention from 
     throughout the country. In addition, the Quality Interagency 
     Coordination Taskforce has recommended steps to improve 
     patient safety that can be taken by each Federal agency 
     involved in health care, and agency activities to implement 
     these steps are ongoing.
       In addition, several non-governmental organizations and 
     professional societies have ``stepped up to the plate'' of 
     patient safety. The Joint Commission on Accreditation of 
     Healthcare Organizations, the U.S. Pharmacopoeia, the 
     American Medical Association, and other health care providers 
     including the American Federation of Hospitals and American 
     Hospital Association have launched innovative efforts 
     dedicated to improving patient safety. However, many of the 
     organizations currently collecting patient safety data have 
     expressed the need for legal protections that will allow them 
     to review protected information so that they may collaborate 
     in the development and implementation of patient safety 
     improvement strategies.
       The work of Lucien Leape, a member of the IOM panel and 
     adjunct professor of health policy at Harvard University, has 
     supported this view. Dr. Leape has argued persuasively that 
     we as a society will continue to have difficulty in reducing 
     medical errors and improving patient safety because our 
     institutions are ``still locked into a blame and punish 
     approach to errors and a focus on individual culpability,'' 
     and that ``the fear of malpractice litigation thus becomes a 
     major barrier to openly discussing and reporting errors.''
       I have introduced legislation with my colleagues, Senators 
     Bill Frist, John Breaux, and Judd Gregg, which seeks to 
     address these concerns. The legislation raises expectations 
     for higher standards for continuous patient safety 
     improvement and it encourages a new and needed culture of 
     patient safety among health care providers and American 
     hospitals. The bill accomplishes these goals by establishing 
     appropriate legal protections for patient safety information 
     voluntarily shared among patient safety organizations and 
     providers. Our legislation reflects the belief that a culture 
     of patient safety can flourish only in an environment where 
     information, data, process, and recommendations enjoy legal 
     protection and privilege.
       Because it appropriately addresses an obvious need and 
     concern, the Jeffords Patient Safety and Quality Improvement 
     Act has enjoyed widespread endorsement by hospital, patient, 
     doctor, and consumer advocacy organizations. This degree of 
     support underscores the broad appeal and essential nature of 
     this proposed legislation.
       In the time since the release of To Err is Human, the 
     Congress has been unable to enact sensible legislation to 
     reduce medical errors and increase patient safety. However I 
     believe we can accomplish that goal this year. The House of 
     Representatives has already passed its version of patient 
     safety legislation and we are working to pass the Patient 
     Safety and Quality Improvement Act in the Senate. I am 
     hopeful that we can reconcile disagreements that have 
     previously stopped this legislation from moving forward and I 
     am committed to seeing that happen.
       It has been three years since the release of the IOM 
     report. That means, based on the IOM's statistics, that an 
     additional 300,000 deaths and an untold number of injuries 
     have occurred from medical errors. We need to apply 
     Hippocrates' admonition to ``first, do no harm'' beyond the 
     medical community to the legislative community. We need to 
     pass legislation now that will help the health care community 
     stop the needless injury caused by unintentional medical 
     errors.

  Mr. JEFFORDS. I offer my appreciation to the many contributions from 
Chairman Gregg, Ranking Member Kennedy, and Senators Frist, Breaux, 
Enzi, Sessions, Dodd, and Bingaman.
  We legislate many essential issues in the Congress, but rarely can we 
say that what we do is a matter of life and death. This, however, is 
one of those issues. The time to act is long overdue. This is an area 
where delay will lead to deaths that can be prevented. I urge all of my 
colleagues to vote in support of this bill.
  Mr. FRIST. I ask unanimous consent that the amendment at the desk be 
agreed to, the committee amendment as amended be agreed to, the bill as 
amended be read a third time, and the HELP Committee be discharged from 
further consideration of H.R. 663, and the Senate proceed to its 
consideration; provided that all after the enacting clause be stricken 
and the text of S. 720, as amended, be inserted in lieu thereof; 
provided further that the bill, as amended, be read a third time and 
passed, the Senate insist upon its amendment and request a conference 
with the House of Representatives on the disagreeing votes of the two 
Houses, and the Chair be authorized to appoint conferees with a ratio 
of 4 to 3.
  Finally, I ask unanimous consent that S. 720 be returned to the 
Calendar.
  The PRESIDING OFFICER. Is there objection?
  Mr. REID. Mr. President, reserving the right to object, I was on the 
Senate floor a few weeks ago with the distinguished chairman of the 
HELP Committee. At that time there was an attempt to move the bill.

[[Page 17020]]

  I said at that time this bill could be done. There were ways we could 
accomplish it. This is an extremely important piece of legislation. 
Through the Chair to the distinguished majority leader, he knows better 
than I. He is a physician. But from what I know of patient safety, this 
is an extremely important piece of legislation, and we have been able 
to do it. We are going to be able to go to conference. There has been 
agreement between the Chair and the ranking member. I think this is an 
important step forward.
  I would say, through the Chair to my friend who is not here, the 
distinguished chairman of the HELP Committee, I am glad he brought this 
to the Senate's attention. I am glad we did not agree to what his 
unanimous consent request was at that time. But we were able to get it 
done, and I am very happy for that.
  I have no objection. This is an important piece of legislation. I now 
wish the conferees well.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 3568) was agreed to.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  The committee amendment in the nature of a substitute, as amended, 
was agreed to.
  The bill (H.R. 663), as amended, was read the third time and passed.
  (The bill will be printed in a future edition of the Record.)
  The Presiding Officer (Mr. Enzi) appointed Mr. Gregg, Mr. Frist, Mr. 
Enzi, Mr. Alexander, Mr. Kennedy, Mr. Dodd, and Mr. Jeffords conferees 
on the part of the Senate.
  Mr. FRIST. Mr. President, I do want to congratulate Senator Gregg, 
chairman of the HELP Committee, and ranking member, Senator Kennedy. 
This is a piece of legislation that people can trace. Several years 
ago, the Institute of Medicine did an outstanding report. We rely on 
the Institute of Medicine again and again to objectively, in a 
nonpartisan way, look at a whole range of issues, from the financing of 
health care, health care delivery, preventive health care, acute 
treatment, chronic treatment. They really respond very much to outside 
bodies like the Senate and do studies.
  One great study they did--people have argued their numbers aren't 
exactly right, too high, too low--but it was that about 100,000 people 
die every year from systems' lapses, medical errors. Those are, for the 
most part, preventable deaths, if you improve the systems. This bill 
goes right at the heart of improving the systems and does so in a way 
that relies on individuals who may observe something that didn't work 
out, sharing that data with their peers in a way that they do not have 
to fear lawsuits.
  Obviously, if there is wrongdoing, lawsuits would be appropriate. 
But, if it is an error, minor error, or even a more serious error, it 
can be addressed upfront in a way that you do not have to be afraid 
somebody is going to come in and crush you from the outside.
  I say that because it is a bipartisan bill. It went through the 
Health, Education, Labor and Pension Committee. I think the fundamental 
structure of the bill went through the committee unanimously. It shows 
tremendous leadership.
  There were disagreements on a few items that have been worked out, 
with Senator Gregg's leadership, working with Senator Kennedy. With 
that, we have a very good bill, a strong bill that will change systems 
of health care in a positive way, and clinics and hospitals and 
physicians offices such that we can eliminate or greatly reduce the 
number of unnecessary medical errors that occur in large part through 
systems approaches.
  Just an example would be if somebody is on 10 different medicines and 
somebody prescribes a new medicine. You don't know the interaction of 
those medicines. You need a system to identify that. That sort of 
organized, commonsense approach to improve systems is made possible by 
this bill.
  Mr. ENZI. Mr. President, the Senate this evening has taken a major 
step toward better and safer health care for all Americans.
  Tonight, we approved the Patient Safety and Quality Improvement Act. 
The goal of this legislation is to allow health care providers some 
freedom from legal fear so they can do what we all strive to do every 
day--learn from our mistakes.
  This bill would create a framework through which hospitals, doctors, 
and other health care providers can work to improve health care quality 
in a protected legal environment. It would accomplish this by granting 
privilege and confidentiality protections to health care providers to 
allow them to report health care errors and ``near misses'' to patient 
safety organizations.
  This bill would not permit anyone to hide information about a medical 
mistake. Lawyers would still have access to medical records and other 
information that would normally be discoverable in a legal proceeding. 
However, the bill would ensure that the analysis of that information by 
patient safety organizations would take place on a separate track in a 
protected legal environment.
  Under the bill, patient safety organizations would have the freedom 
to collect and analyze data on health care errors in confidence, and 
then report their findings to the health care community. These findings 
would help health care providers understand how mistakes happen in our 
health care system, and how to prevent them.
  If we can reach an agreement in conference in the House and send this 
bill to the President, health care providers will be much more likely 
to share information about honest mistakes, because they will have some 
assurance that the analysis of their information won't result in a tidy 
package of information that a personal injury lawyer could use against 
them in court.
  I express my appreciation for the hard work that the members of the 
Committee on Health, Education, Labor, and Pensions put into this bill, 
particularly Chairman Gregg, Majority Leader Frist, the lead sponsor 
Senator Jeffords, and Senators Sessions and Kennedy.
  I also thank the staff who worked so diligently over the course of 
this Congress to craft this legislation, particularly Vince 
Ventimiglia, Peggy Carlson, David Fisher, Dean Rosen, Jim Hippe, Sean 
Donohue, Megan Clarke, David Nexon, David Bowen, and of course Stephen 
Northrup with my office.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. FRIST. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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