Patient Safety Act of 1996

Summary: Patient Safety Act of 1996 - Requires providers under the Medicare program, as a condition for continued participation in the program, to make publicly available certain minimum information, in addition to information specified by the Secretary of Health and Human Services, regarding nurse staffing and patient outcomes. 
Requires the following to be made public along with its source and currency status:  (1) data regarding complaints filed with the State agency with oversight over health care services, the Health Care Financing Administration, or a provider accrediting agency; (2) compliance with the standards deemed to demonstrate compliance with conditions of Medicare participation; and (3) data regarding investigations and findings as a result of those complaints and the findings of scheduled inspection visits. 
Allows the Secretary to waive or reduce reporting requirements in the case of a small provider for whom their imposition would be unduly burdensome. 
Prohibits Medicare providers from terminating or taking any other adverse action against any employee or groups of employees for certain actions, including those taken for the purpose of notifying the provider of conditions potentially dangerous or injurious to patients receiving services from the provider or to employees of the provider. Requires provider termination from participation in Medicare for taking such an adverse action. 
Requires any provider under Medicare that files with the Department of Justice and the Federal Trade Commission notification of a transaction required to be reported under the Clayton Act to provide to the Secretary a report that includes:  (1) the overall impact of such transaction on the health services available and readily accessible to the community; and (2) the impact of such transaction on each of various specified subjects, including the availability and accessibility of services to the poor, the uninsured, ethnic minorities, women, the disabled, and the lesbian and gay communities. 
Requires public availability of such reports, public hearings on their elements and any other factors related to the health, safety, and welfare of patients and the community involved, secretarial review of each such proposed transaction based on the report, hearing testimony, and any other relevant factors. 
Deems any provider that executes a transaction found to have a negative impact on health and safety (or that fails to file a required report) not to be in compliance with the conditions of Medicare participation.  Mandates the provider's immediate suspension from program participation if it completes a transaction that poses immediate jeopardy or irreparable harm to patient health, safety, or welfare.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Safety Act of 1996''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) There has been increased and growing public concern 
        expressed regarding the quality and safety of services provided 
        by health care facilities and institutions, as such facilities 
        have instituted aggressive efforts to reduce levels of staff 
        who provide direct patient care services as a principal means 
        of decreasing expenses.
            (2) A growing body of data suggests a linkage between the 
        number and mix of nursing staff and positive patient care 
        outcomes, including the avoidance of patient death and injury.
            (3) Many employees of health care facilities have expressed 
        fear for their employment if they report unsafe conditions, 
        including violations of State or Federal law.
            (4) Unprecedented consolidation among health care 
        institutions has led to increasing concern regarding the effect 
        of such activity on the health and safety of communities served 
        by these facilities, yet the Federal Government has little 
        authority to evaluate such effect in deciding whether or not to 
        approve mergers and acquisitions among health care facilities.

SEC. 3. DEFINITIONS.

    For purposes of this Act:
            (1) Licensed practical nurse or licensed vocational 
        nurse.--The term ``licensed practical nurse or licensed 
        vocational nurse'' means an individual who is entitled under 
        State law or regulation to practice as a licensed practical 
        nurse or a licensed vocational nurse.
            (2) Made publicly available.--The term ``made publicly 
        available'' means, with respect to information of a provider, 
        information that is--
                    (A) provided to the Secretary and to any State 
                agency responsible for licensing or accrediting the 
                provider;
                    (B) provided to any State agency which approves or 
                oversees health care services delivered by the provider 
                directly or through an insuring entity or corporation; 
                and
                    (C) provided to any member of the public which 
                requests such information directly from the provider.
            (3) Medicare program.--The term ``medicare program'' means 
        the programs under title XVIII of the Social Security Act.
            (4) Provider.--The term ``provider'' means an entity that 
        is--
                    (A) a psychiatric hospital described in section 
                1861(f) of the Social Security Act,
                    (B) a provider of services described in section 
                1861(u) of such Act,
                    (C) a rural health clinic described in section 
                1861(aa)(2) of such Act,
                    (D) an ambulatory surgical center described in 
                section 1832(a)(2)(F)(i) of such Act, or
                    (E) a renal dialysis facility described in section 
                1881(b)(1)(A) of such Act.
            (5) Registered nurse.--The term ``registered nurse'' means 
        an individual who is entitled under State law or regulation to 
        practice as a registered nurse.
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 4. PUBLIC DISCLOSURE OF STAFFING AND OUTCOMES DATA.

    (a) Disclosure of Staffing and Outcomes.--Any provider under the 
medicare program shall, as a condition of continued participation in 
such program, make publicly available information regarding nurse 
staffing and patient outcomes as specified by the Secretary. Such 
information shall include at least the following:
            (1) The number of registered nurses providing direct care. 
        This information shall be expressed both in raw numbers, in 
        terms of total hours of nursing care per patient (including 
        adjustment for case mix and acuity), and as a percentage of 
        nursing staff, and shall be broken down in terms of the total 
        nursing staff, each unit, and each shift.
            (2) The number of licensed practical nurses or licensed 
        vocational nurses providing direct care. This information shall 
        be expressed both in raw numbers, in terms of total hours of 
        nursing care per patient (including adjustment for case mix and 
        acuity), and as a percentage of nursing staff, and shall be 
        broken down in terms of the total nursing staff, each unit, and 
        each shift.
            (3) Numbers of unlicensed personnel utilized to provide 
        direct patient care. This information shall be expressed both 
        in raw numbers and as a percentage of nursing staff and shall 
        be broken down in terms of the total nursing staff, each unit, 
        and each shift.
            (4) The average number of patients per registered nurse 
        providing direct patient care. This information shall be broken 
        down in terms of the total nursing staff, each unit, and each 
        shift.
            (5) Patient mortality rate (in raw numbers and by diagnosis 
        or diagnostic-related group).
            (6) Incidence of adverse patient care incidents, including 
        as such incidents at least medication errors, patient injury, 
        decubitus ulcers, nosocomial infections, and nosocomial urinary 
        tract infections.
            (7) Methods used for determining and adjusting staffing 
        levels and patient care needs and the provider's compliance 
        with these methods.
    (b) Disclosure of Complaints.--Data regarding complaints filed with 
the State agency, the Health Care Financing Administration, or an 
accrediting agency, compliance with the standards of which have been 
deemed to demonstrate compliance with conditions of participation under 
the medicare program, and data regarding investigations and findings as 
a result of those complaints and the findings of scheduled inspection 
visits, shall be made publicly available.
    (c) Information on Data.--All data made publicly available under 
this section shall indicate the source and currency of the data 
provided.
    (d) Waiver for Small Providers.--The Secretary may waive or reduce 
reporting requirements under this section in the case of a small 
provider (as defined by the Secretary) for whom the imposition of the 
requirements would be unduly burdensome.

SEC. 5. PROTECTION OF CERTAIN ACTIVITIES BY EMPLOYEES OF MEDICARE 
              PROVIDERS.

    (a) In General.--No provider under the medicare program shall 
terminate or take other adverse action against any employee or groups 
of employees for actions taken for the purpose of--
            (1) notifying the provider of conditions which the employee 
        or group of employees identifies, in communications with the 
        provider, as dangerous or potentially dangerous or injurious 
        to--
                    (A) patients who currently receive services from 
                the provider;
                    (B) individuals who are likely to receive services 
                from the provider; or
                    (C) employees of the provider;
            (2) notifying a Federal or State agency or an accreditation 
        agency, compliance with the standards of which have been deemed 
        to demonstrate compliance with conditions of participation 
        under the medicare program, of such conditions as are 
        identified in paragraph (1);
            (3) notifying other individuals of conditions which the 
        employee or group of employees reasonably believe to be such as 
        are described in paragraph (1);
            (4) discussing such conditions as are identified in 
        paragraph (1) with other employees for the purposes of 
        initiating action described in paragraph (1), (2), or (3); or
            (5) other related activities as specified in regulations 
        promulgated by the Secretary.
    (b) Sanction.--A determination by the Secretary that a provider has 
taken such action as described in subsection (a) shall result in 
termination from participation in the medicare program for a period of 
time to be specified by the Secretary, such period to be not less than 
1 month.
    (c) Exception.--The protections of this section shall not apply to 
any employee who knowingly or recklessly provides substantially false 
information to the Secretary.

SEC. 6. EVALUATION OF HEALTH AND SAFETY OF CERTAIN MERGERS AND 
              ACQUISITIONS BY OR AMONG MEDICARE PROVIDERS.

    (a) Impact Report.--Any provider under the medicare program that 
files with the Department of Justice and the Federal Trade Commission 
notification of a transaction which is required to be reported pursuant 
to section 7A of the Clayton Act (15 U.S.C. 18a) shall, on the same 
date as such notification is submitted, provide the Secretary with a 
written report that includes the overall impact of such transaction on 
the health services available and readily accessible to the community 
and that includes the impact of such transaction on each of the 
following:
            (1) On the availability and accessibility of primary, acute 
        care, and emergency services.
            (2) On the availability and accessibility of services for 
        mothers and children.
            (3) On the availability and accessibility of services to 
        the elderly.
            (4) On the availability and accessibility of services to 
        other specific populations, including the poor, the uninsured, 
        ethnic minorities, women, the disabled, and the lesbian and gay 
        communities.
            (5) On the availability and accessibility of specialized 
        services, including services for the prevention, detection, and 
        treatment of the human immunodeficiency virus and related 
        illnesses, mental health services, and substance abuse 
        services.
            (6) On the safety and quality of health care services to be 
        provided, including anticipated changes in numbers and mix of 
        nursing and other patient care staff and on other factors 
        related to patient outcomes.
            (7) On the availability and accessibility of social 
        services and other services within the community.
            (8) On overall employment within the community.
            (9) On the provider's workforce, including--
                    (A) the status of existing collective bargaining 
                contracts, if any; and
                    (B) plans for retraining and redeployment of 
                employees who are displaced as a result of the 
                contemplated transaction.
            (10) On the financial stability of the merged entity, 
        taking into account at least projected acquisition costs, 
        related expenses, and planned marketing or advertising 
        campaigns for the new entity.
            (11) On other factors to be specified in regulations to be 
        promulgated by the Secretary.
Such report shall be in addition to any documentation required by any 
other Federal or State agency.
    (b) Availability.--A report under subsection (a) shall be made 
publicly available by the provider and by the Secretary upon request. 
In addition, the provider shall make publicly available any 
documentation submitted to the Department of Justice, the Federal Trade 
Commission, or other Federal or State agency regarding the contemplated 
transaction.
    (c) Hearings.--The Secretary shall conduct, or arrange for, public 
hearings on the elements of each report submitted under subsection (a) 
and any other factors related to the health, safety, and welfare of 
patients served by the provider and the community involved, including 
the provider's workforce. Such hearings shall be held at a time or 
times and location or locations readily accessible to the public and 
may be conducted jointly with relevant State agencies.
    (d) Review.--The Secretary shall review each such proposed 
transaction. Such review shall be based on the written report submitted 
under subsection (a), a transcript of testimony at the public hearing 
under subsection (c), and any other factors which the Secretary finds 
are relevant to the health, safety, and welfare of the patients served 
by the provider and the community, including the provider's workforce.
    (e) Findings.--(1) The Secretary shall, within 45 days of 
completion of a hearing under subsection (c), issue written findings on 
the likely impact of the contemplated transaction on the health and 
safety of the patients and communities served by the provider, 
including the provider's workforce.
    (2) If the Secretary determines that the overall impact of the 
transaction on the health and safety of patients and the community is a 
negative one, the Secretary shall issue, as part of the findings, a 
finding of negative impact on health and safety.
    (3) In issuing findings under this subsection, the Secretary may 
confer with such other agencies (such as the Department of Justice, the 
Federal Trade Commission, and the Department of Labor) as may have an 
interest in the impact on the public of the proposed transaction.
    (f) Sanctions.--A provider that executes a transaction which is the 
subject of a finding of negative impact on health and safety under 
subsection (e)(2) (or a provider which fails to file a report with the 
Secretary pursuant to subsection (a)) shall be deemed not to be in 
compliance with the conditions of participation under the medicare 
program. Such a determination shall be subject to such procedures and 
appeal as provided for in regulations promulgated by the Secretary. In 
the case of a determination that conditions effected by the transaction 
in question pose immediate jeopardy or irreparable harm to patient 
health, safety, and welfare, the Secretary shall (if such transaction 
is completed) immediately suspend the entity's participation in the 
medicare program and such suspension shall continue in force during any 
administrative or judicial review for the transaction sought by the 
entity.