A bill 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 effect patient safety.

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 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 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).

Summary: Patient Safety and Quality Improvement Act - Amends the Public Health Service Act to make patient safety data privileged and confidential. Excludes such data from subpoena, discovery, disclosure under the Freedom of Information Act (FOIA), evidentiary use, or any credentialing or licensing situation. Permits disclosures necessary to the proper management and administration of the patient safety organization, including maintenance of a patient's medical record, in a disciplinary proceeding relating to a provider, or as needed by the Food and Drug Administration for regulatory purposes. Authorizes the establishment of a database for non-identifiable patient safety data, consistent, if practicable, with the administrative simplification provisions of the Social Security Act. Authorizes technical assistance, including annual meetings for patient safety organizations. Requires the Secretary of Health and Human Services to develop or adopt voluntary national standards promoting the integration of health care information technology systems. Requires the Secretary to contract for and report to Congress on a study assessing the impact of medical technologies and therapies on patient safety and benefit, health care quality and costs, as well as productivity growth. Directs the Attorney General to survey and report to Congress on State laws and their interpretation as they relate to patient safety data peer review systems.