[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4889 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4889

To amend title XI of the Social Security Act to improve patient safety.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 2002

Mrs. Johnson of Connecticut (for herself, Mr. Thomas, Mr. Houghton, Mr. 
    Fletcher, Mrs. Morella, Mr. Hayworth, Mr. Weller, and Mr. Camp) 
 introduced the following bill; which was referred to the Committee on 
    Ways and Means, and in addition to the Committee on Energy and 
Commerce, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title XI of the Social Security Act to improve patient safety.

    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 
Improvement Act of 2002''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Patient safety improvements.
                 ``Part D--Patient Safety Improvements

        ``Sec. 1181. Voluntary reporting of patient safety data; 
                            definitions.
        ``Sec. 1182. Confidentiality and peer review protections.
        ``Sec. 1183. Reduction of medical errors using non-identifiable 
                            patient safety data reported to patient 
                            safety organization.
        ``Sec. 1184. Technical assistance.
        ``Sec. 1185. Interoperability standards for health care 
                            information technology systems.
Sec. 3. Medical Information Technology Advisory Board.

SEC. 2. PATIENT SAFETY IMPROVEMENTS.

    (a) In General.--Title XI of the Social Security Act is amended by 
adding at the end the following new part:

                 ``Part D--Patient Safety Improvements

       ``voluntary reporting of patient safety data; definitions

    ``Sec. 1181. (a) Voluntary Reporting.--The reporting of patient 
safety data by health care providers under this part is voluntary.
    ``(b) Definitions.--In this part:
            ``(1) 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 health 
                        care 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 health care provider 
                        by a patient safety organization;
                            ``(v) collected or developed by a patient 
                        safety organization; or
                            ``(vi) reported among patient safety 
                        organizations; 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.
            ``(2) Patient safety organization.--
                    ``(A) In general.--The term `patient safety 
                organization' means a private or public organization or 
                component thereof that certifies to the Secretary that 
                it performs each of the activities described in 
                subparagraph (B) (which are necessary for the proper 
                management and administration of such organization or 
                component) and meets the conflict of interest standard 
                under subparagraph (C).
                    ``(B) Activities described.--The activities 
                referred to in subparagraph (A) are the following:
                            ``(i) The conduct, as its primary activity, 
                        of efforts to improve patient safety and the 
                        quality of health care delivery by assisting 
                        health care providers that report to such 
                        organizations.
                            ``(ii) The collection and analysis of 
                        patient safety data that are voluntarily 
                        submitted by a health care provider.
                            ``(iii) The development and dissemination 
                        of information to health care providers with 
                        respect to improving patient safety, such as 
                        recommendations, protocols, or information 
                        regarding best practices.
                            ``(iv) The utilization of patient safety 
                        data to carry out activities under this 
                        subparagraph and for the purposes of 
                        encouraging a culture of safety and of 
                        providing direct feedback and assistance to 
                        health care providers to effectively minimize 
                        patient risk.
                            ``(v) The maintenance of confidentiality 
                        with respect to individually identifiable 
                        health information.
                            ``(vi) The provision of appropriate 
                        security measures with respect to patient 
                        safety data.
                    ``(C) Conflict of interest standard.--The conflict 
                of interest standard referred to in subparagraph (A) 
                for a patient safety organization, with respect to a 
                health care provider, is that the organization does not 
                use patient safety data submitted under this part to 
                take regulatory or enforcement actions it otherwise 
                performs (or is responsible for performing) in relation 
                to such provider.
            ``(3) Health care provider.--The term `health care 
        provider' means--
                    ``(A) a provider of services (as defined in section 
                1861(u), and including a hospital, skilled nursing 
                facility, home health agency, and hospice program) that 
                provides services for which payment may be made under 
                part A of title XVIII;
                    ``(B) a health care entity or individual that 
                furnishes medical or other health services (as defined 
                in section 1861(s)) or other services described in 
                section 1832(a)(2) for which payment may be made under 
                part B of such title, including a physician (as defined 
                in section 1861(r)); and
                    ``(C) a Medicare+Choice organization under part C 
                of such title.

             ``confidentiality and peer review protections

    ``Sec. 1182. (a) In General.--Notwithstanding any other provision 
of law, and subject to subsection (b), patient safety data shall be 
privileged and confidential and 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 or 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.
    ``(b) Disclosure Requirements.--Nothing in this section shall be 
construed to prohibit one or more of the following disclosures:
            ``(1) Disclosures by a health care provider in complying 
        with authorized requests for the provision of patient safety 
        information (such as a patient's medical record or other 
        relevant information) that is in the control of such a health 
        care provider and that has been developed, maintained, or 
        exists separately from the process by which the health care 
        provider collects or develops information for reporting to a 
        patient safety organization.
            ``(2) Disclosures by a health care provider or patient 
        safety organization of patient safety data as part of a 
        disciplinary proceeding relating to a health care 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 health care 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.
            ``(4) Disclosures by a health care provider or patient 
        safety organization of information to which subsection (a) 
        applies to carry out activities described in section 
        1181(b)(2)(B).
    ``(c) Penalty.--It is unlawful for any person to disclose any 
patient safety data in violation of the provisions of this section. Any 
person violating such provisions shall be subject to the same sanctions 
under section 1160(c) as a person who discloses any information 
described in section 1160(a).
    ``(d) 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.
    ``(e) 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.
    ``(f) Treatment of Residual Patient Safety Data.--In the case of a 
patient safety organization which no longer qualifies as a patient 
safety organization under section 1181(b)(2) that received patient 
safety data from a health care provider, the organization shall return 
the data to the provider, if practicable, or destroy the data.

``reduction of medical errors using aggregated non-identifiable patient 
          safety data reported to patient safety organization

    ``Sec. 1183. (a) Analysis of Patterns of Medical Errors.--
            ``(1) In general.--The Secretary shall establish one or 
        more mechanisms--
                    ``(A) to analyze aggregate non-identifiable patient 
                safety data (as defined in paragraph (3))--
                            ``(i) to identify patterns of medical 
                        errors; and
                            ``(ii) to disseminate to health care 
                        providers methods that can be systematically 
                        employed; and
                    ``(B) to analyze system changes adopted by patient 
                safety organizations and health care providers;
        in order to reduce such errors and improve patient safety and 
        health care quality.
            ``(2) Periodic reports.--The Secretary shall periodically 
        report to Congress on mechanisms established under paragraph 
        (1) and on changes that should be made to the provisions of 
        this part in order to best promote system-wide improvements in 
        patient safety and quality.
            ``(3) Non-identifiable patient safety data defined.--For 
        purposes of this section, the term `non-identifiable patient 
        safety data' means patient safety data voluntarily reported to 
        a patient safety organization under this part that are 
        presented in a form and manner that prevent the identification 
        of any health care provider, patient, and the reporter of the 
        data.
    ``(b) Confidentiality.--Any patient safety data that are used under 
this section shall be privileged and confidential in the same manner as 
provided under section 1182 with respect to such data reported to a 
patient safety organization.

                         ``technical assistance

    ``Sec. 1184. The Secretary may provide technical assistance to 
patient safety organizations in providing recommendations and advice to 
health care providers submitting patient safety data under this part. 
Such assistance shall include advice with respect to methodology, 
communication, data collection, security, and confidentiality concerns.

  ``interoperability standards for health care information technology 
                                systems

    ``Sec. 1185. (a) In General.--By not later than 2 years after the 
date of the enactment of this part, the Secretary shall develop (and 
shall periodically review and update) voluntary, national standards 
that promote the interoperability of health care information technology 
systems across all health care settings.
    ``(b) Consultation.--The Secretary shall develop and update such 
standards in consultation with--
            ``(1) the National Committee for Vital and Health 
        Statistics,
            ``(2) the organizations referred to in section 
        1172(c)(3)(B), and
            ``(3) the Medical Information Technology Advisory Board 
        (established under section 3 of the Patient Safety Improvement 
        Act of 2002).
    ``(c) Dissemination.--The Secretary shall provide for the 
dissemination of the standards developed and updated under this 
section.''.

SEC. 3. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.

    (a) Establishment.--
            (1) In general.--Not later than 3 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 appoint an advisory board to be known as the ``Medical 
        Information Technology Advisory Board'' (in this section 
        referred to as the ``MITAB'').
            (2) Chairman; vice chairman.--The Secretary shall designate 
        one member as chairman and one as vice 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.
    (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 the Centers for 
                Medicare & Medicaid Services;
                    (C) one or more staff experts from the Agency for 
                Healthcare Research and Quality;
                    (D) one or more staff experts from the Institute of 
                Medicine of the National Academy of Sciences;
                    (E) representatives of private organizations with 
                expertise in medical infomatics;
                    (F) one or more staff experts of a public health 
                agency;
                    (G) a representative of a teaching hospital; and
                    (H) 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) Initial report.--No later than 30 months after the date 
        of the enactment of this Act, the MITAB shall submit to 
        Congress and the Secretary a report on the following:
                    (A) The best current practices in medical 
                information technology.
                    (B) Methods of implementing--
                            (i) health care information technology 
                        interoperability standardization; and
                            (ii) records security
                    (C) A recommendation for a common lexicon for 
                computer technology.
            (2) Subsequent reports.--During each of the 2 years after 
        the year in which the report is submitted under paragraph (1), 
        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 1185 of the Social Security 
        Act, and such other matters as may help ensure the most rapid 
        dissemination of best practices in health care information 
        technology.
    (d) Goals.--The goals described in this subsection are the 
following:
            (1) To maximize positive outcomes in clinical care--
                    (A) by providing decision support for diagnosis and 
                care; and
                    (B) by assisting in the emergency treatment of a 
                patient presenting at a facility where there is no 
                medical record of the patient.
            (2) 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 (as enacted into law by 
        section 1(a)(6) of Public Law 106-554), and to assist in 
        minimizing the need for new and different records as patients 
        move from provider to provider.
            (3) To reduce or eliminate the need for redundant records, 
        paperwork, and the repetitive taking of patient histories and 
        administering of tests.
            (4) To minimize medical errors, such as administration of 
        contraindicated drugs.
            (5) To promote and ensure access to best practices of 
        medicine through support of research across institutions.
            (6) 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.
    (e) 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.
            (5) Physical facilities.--The Administrator of the General 
        Services Administration shall locate suitable office space for 
        the operation of the MITAB. The facilities shall serve as the 
        headquarters of the MITAB and shall include all necessary 
        equipment and incidentals required for the proper functioning 
        of the MITAB.
    (f) 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) Use of mails.--The MITAB may use the United States 
        mails in the same manner and under the same conditions as 
        Federal agencies and shall, for purposes of the frank, be 
        considered a commission of Congress as described in section 
        3215 of title 39, United States Code.
            (5) 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.
            (6) Administrative support services.--Upon the request of 
        the MITAB, the Administrator of General Services shall provide 
        to the MITAB on a reimbursable basis such administrative 
        support services as the MITAB may request.
            (7) Printing.--For purposes of costs relating to printing 
        and binding, including the cost of personnel detailed from the 
        Government Printing Office, the MITAB shall be deemed to be a 
        committee of the Congress.
    (g) Termination.--The MITAB shall terminate 30 days after the date 
of submission of its final report under subsection (c)(2).
    (h) Authorization of Appropriations.--There are authorized to be 
appropriated to the Secretary of Health and Human Services such sums as 
are necessary to carry out this section.
                                 <all>