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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9037 Introduced in House (IH)]

<DOC>

116th CONGRESS
  2d Session
                                H. R. 9037

 To amend the Public Health Service Act to ensure transparency within 
    the health care system through the establishment of a National 
   Healthcare Acquired Infection and Medical Error Reporting Program.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           December 20, 2020

 Ms. Gabbard introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend the Public Health Service Act to ensure transparency within 
    the health care system through the establishment of a National 
   Healthcare Acquired Infection and Medical Error Reporting Program.

    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 ``National Healthcare Acquired 
Infection and Medical Error Transparency Act''.

SEC. 2. FINDINGS.

            (1) The Centers for Disease Control and Prevention reported 
        that each day one in thirty-one hospital patients has at least 
        one healthcare-associated infection;
            (2) 32 percent of all healthcare-acquired infections are 
        urinary tract;
            (3) 22 percent of all infections are surgical site 
        infections;
            (4) 15 percent are pneumonia (lung infections);
            (5) 14 percent are bloodstream infections.
            (6) Patients who acquire infections from surgery spend on 
        average an additional 6.5 days hospitalized;
            (7) are five times more likely to be readmitted after 
        discharge;
            (8) and are twice as likely to die.
            (9) As recent as 2016, Johns Hopkins University patient 
        safety experts calculated that medical error is responsible for 
        at least 250,000 deaths per year (the third leading cause of 
        death in the U.S.).

SEC. 3. ESTABLISHMENT OF OFFICE OF PATIENT SAFETY AND HEALTH CARE 
              QUALITY.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended--
            (1) by redesignating part E as part F;
            (2) in part F, as redesignated--
                    (A) by redesignating sections 941 through 948 as 
                sections 951 through 958, respectively; and
                    (B) in section 958(1), as redesignated, by striking 
                ``941'' and inserting ``951''; and
            (3) by inserting after part D the following:

  ``PART E--NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL ERROR 
                           REPORTING PROGRAM

``SEC. 941. DEFINITIONS.

    ``In this part:
            ``(1) Anti-retaliation.--The term `anti-retaliation' any 
        patient or legal representative of a patient who engages in 
        Protected Activity will be shielded from retaliation.
            ``(2) Database.--The term `Database' means the National 
        Patient Safety Database established under section 944.
            ``(3) Health care provider.--The term `health care 
        provider' means a person or entity licensed or otherwise 
        authorized under State law to provide health care services, 
        including--
                    ``(A) a hospital, health plan, community clinic, 
                nursing facility, comprehensive rehabilitation 
                facility, home health agency, hospice program, renal 
                dialysis facility, ambulatory surgical center, 
                pharmacy, doctor's or health care practitioner's 
                office, long-term care facility, behavior health 
                residential treatment facility, clinical laboratory, or 
                health center;
                    ``(B) a doctor, nurse, physician assistant, nurse 
                practitioner, clinical nurse specialist, certified 
                nurse anesthetist, certified nurse midwife, 
                psychologist, certified social worker, registered 
                dietitian or nutrition professional, physical or 
                occupational therapists, pharmacist, or other 
                individual healthcare practitioner; and
                    ``(C) any other health care professional specified 
                in regulations promulgated by the Secretary.
            ``(4) Healthcare acquired infection.--The term `Healthcare 
        Acquired Infection(s) (HAI)' means an infection that is 
        contracted while in a healthcare facility, such as an acute 
        care hospital, skilled nursing care facility, or doctor's 
        office or clinic.
            ``(6) Medical error.--The term `medical error' means an 
        unexpected occurrence involving death or serious physical or 
        psychological injury, or the risk of such injury, including any 
        process variation of which recurrence may carry significant 
        chance of a serious adverse outcome.
            ``(7)  Office.--The term `Office' means the Office of 
        Patient Safety and Health Care Quality established under 
        section 943, which shall be a certified patient safety 
        organization as defined under part C.
            ``(8) Outcomes.--The term `outcomes' means any result of 
        healthcare acquired infection and/or medical error on affected 
        patients.
            ``(9) Patient safety data.--The term `patient safety data' 
        means information requested by the Director of the Office to be 
        submitted by the patient safety officer of a Program 
        participant as described in section 945(e).
            ``(6) Patient safety event.--The term `patient safety 
        event' means an occurrence, incident, or process that either 
        contributes to, or has the potential to contribute to, a 
        patient injury or degrades the ability of health care providers 
        to provide the appropriate standard of care.
            ``(7) Patient safety officer.--The term `patient safety 
        officer' means the individual designated by a Program 
        participant as being responsible for ensuring that the 
        conditions for participation in the Program are met.
            ``(8) Patient safety organization.--The term `patient 
        safety organization' has the meaning given such term in section 
        921.
            ``(9)  Patient safety work product.--The term `patient 
        safety work product' has the meaning given such term in section 
        921.
            ``(10) Program.--The term `Program' means the National 
        Healthcare Acquired Infections and Medical Error Reporting 
        Program established under section 945.
            ``(11) Program participant.--The term `program participant' 
        means any healthcare provider who reports healthcare acquired 
        infections and/or medical errors to the National Healthcare 
        Acquired Infections and Medical Error Reporting Program.
            ``(12) Root cause analysis.--The term `root cause analysis' 
        means an examination or investigation of an occurrence, event, 
        or incident to determine if a preventable medical error took 
        place or the standard of care was not followed and to identify 
        the causal factors that led to such occurrence, event, or 
        incident.
            ``(14) Whistleblower.--The term `whistleblower' means any 
        individual or legal representative of an individual, who 
        provides original information relating to a Healthcare Acquired 
        Infection or Medical Error outcome.

``SEC. 942. PURPOSE AND GOALS.

    ``It is the purpose of this legislation to promote a culture of 
safety and trust within hospitals, health systems, clinics, and other 
sites of health care, through the establishment of a National 
Healthcare Acquired Infection and Medical Error Reporting Program. It 
shall be a goal of the Program to--
            ``(1) establish standardized procedures for States to 
        provide reports detailing healthcare acquired infection and 
        medical error disclosure and reporting;
            ``(2) require all State departments of health to use the 
        data provided by hospitals for error reporting to analyze 
        trends and identify best practices;
            ``(3) reduce rates of preventable medical errors; and
            ``(4) ensure patients have access to information for 
        medical injury or illness due to medical error, negligence, or 
        malpractice.

``SEC. 943. OFFICE OF PATIENT SAFETY AND HEALTH CARE QUALITY.

    ``(a) In General.--The Secretary shall establish within the Office 
of the Secretary, an Office of Patient Safety and Health Care Quality 
to collaborate with the Director of the Agency for Health Care Research 
and Quality to improve patient safety and reduce medical error across 
the health care system. The Office shall be headed by a Director to be 
appointed by the Secretary.
    ``(b)  Activities.--The activities of the Office shall be deemed 
patient safety activities, as defined in section 921.
    ``(c) Duties.--The Director of the Office shall--
            ``(1) establish and administer the Program;
            ``(2) determine who is eligible for participation in the 
        Program in accordance with section 945;
            ``(3) contract with an independent entity for the purpose 
        of evaluating the Program at least once every two years, with 
        the results of such evaluations being disseminated to Program 
        participants, Congress, and the public;
            ``(4) establish and maintain, in consultation with patient 
        safety organizations, health care quality organizations, health 
        care providers, and the health information technology industry, 
        a National Patient Safety Database as provided for in section 
        944 to receive nonidentifiable patient safety work product as 
        described in the reporting requirements for Program 
        participants under section 945(c)(10);
            ``(5) determine and adopt a standardized patient safety 
        taxonomy, necessary elements, common and consistent 
        definitions, and standardized formats for the electronic 
        reporting of patient safety data to the Database as described 
        in section 944(e);
            ``(6) survey Federal, State, and local requirements for the 
        reporting of patient safety data and work to streamline and 
        reduce duplication of such requirements;
            ``(7) grant patient safety organizations, researchers, and 
        other qualified individuals and institutions access to the 
        Database as determined appropriate through the evaluation of 
        completed applications submitted to the Office for such 
        purpose;
            ``(8) analyze, directly or through a contract with a 
        patient safety organization, all data entered into the Database 
        and provide Program participants, Congress, and the public with 
        healthcare acquired infection and medical error trend reports 
        and other analyses as determined appropriate by the Director on 
        a quarterly basis;
            ``(9) develop, directly or through a contract with a 
        patient safety organization, safety and training 
        recommendations for health care providers that focus on the 
        reduction of medical errors, improved patient safety, and 
        increased quality of care on at least a yearly basis;
            ``(10) maintain a publicly accessible internet website to 
        provide patients and health care providers with information 
        concerning the Program and the Database; and
            ``(11) perform any other duties for the administration of 
        the Program as determined necessary by the Secretary.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out the activities of the Office.

``SEC. 944. NATIONAL PATIENT SAFETY DATABASE.

    ``(a) In General.--The Director of the Office shall, in accordance 
with section 943(c)(6), establish a National Patient Safety Database 
that shall--
            ``(1) adopt standardized patient safety taxonomy in 
        consultation with the Joint Commission on Accreditation of the 
        Healthcare Organizations and other entities with relevant 
        expertise;
            ``(2) include necessary elements, common and consistent 
        definitions, and a standardized electronic interface for the 
        entry and processing of the data by Program participants, as 
        developed by the Director in consultation with patient safety 
        organizations, health care providers, and the health 
        information technology industry;
            ``(3) allow for the comprehensive collection and analysis 
        of the patient safety data required to be submitted by all 
        Program participants under section 945; and
            ``(4) include patient safety data required to be submitted 
        by Program participants under section 945 as nonidentifiable 
        patient safety work product and privileged and confidential in 
        accordance with section 922.
    ``(b) Limitation.--Information submitted to the Database shall be 
confidential and protected from disclosure in accordance with the 
regulations promulgated under section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
    ``(c)  Access.--Access to the patient safety data contained within 
the Database shall only be provided through application to and approval 
by the Director.

``SEC. 945. NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL ERROR 
              REPORTING PROGRAM.

    ``(a)  Establishment.--The Secretary, acting through the Director 
of the Office, shall establish a National Healthcare Acquired Infection 
and Medical Error Reporting Program to provide for the confidential 
disclosure of medical errors and patient safety events in order to 
improve patient safety and health care quality, reduce preventable 
medical errors, ensure patient access to data and reports for medical 
injury due to medical error, negligence, or malpractice.
    ``(b) Eligible Participants.--To be eligible to participate in the 
Program an entity shall--
            ``(1)(A) be a healthcare provider; or
            ``(B) be any other entity determined to be eligible by the 
        Director;
            ``(2) designate a patient safety officer to ensure that the 
        conditions of participation described in subsection (c) are 
        met;
            ``(3) submit a completed application to the Office at such 
        time, in such manner, and containing such information as the 
        Director may require; and
            ``(4) agree to comply with the conditions of participation 
        under subsection (c).
    ``(c) Conditions of Participation.--A Program participant shall, 
directly or indirectly--
            ``(1) submit a comprehensive plan, as part of the 
        application for participation in the Program, to reduce the 
        incidence of medical errors and improve patient safety in the 
        case of a Program participant that is a health care provider, 
        activities that result in the reduction of medical errors or 
        that otherwise improve patient safety;
            ``(2) require health care providers included in the Program 
        by the Program participant and as outlined in the Program 
        participant application, to submit to the patient safety 
        officer a report of any incident or occurrence involving a 
        patient that is thought to either be a medical error or patient 
        safety event;
            ``(3) ensure that the reports filed under paragraph (2) are 
        submitted to the Database in a standardized format as 
        designated by the Director;
            ``(4) where appropriate, ensure that a root cause analysis 
        of any report submitted to the patient safety officer under 
        paragraph (2) is performed within 90 days of the filing of a 
        report under such paragraph;
            ``(5) ensure that if a patient was harmed or injured as the 
        result of a healthcare acquired infection or medical error, or 
        as a result of the relevant standard of care not being 
        followed, an account of the incident or occurrence, as 
        described in paragraph (2) shall be disclosed to the patient 
        not later than 5 business days after the completion of root 
        cause analysis;
            ``(6) disclose information contained in any report 
        submitted to the patient safety officer under paragraph (2) 
        upon the request of the patient with respect to whom the report 
        has been filed;
            ``(7) offer, at the time of disclosure of an incident or 
        occurrence in which it was determined that a patient was harmed 
        or injured as a result of medical error or as a result of the 
        relevant standard of care not being followed, to share, where 
        practicable, any efforts the health care provider will 
        undertake to prevent reoccurrence; and
            ``(8) prepare and submit entries to the Database as 
        required by the Director of the Office and in accordance with 
        subsection (d).
    ``(d)  Submission of Patient Safety Data.--
            ``(1) In general.--All entries into the Database shall--
                    ``(A) contain only non-identifiable patient safety 
                work product;
                    ``(B) be in a standardized electronic format to be 
                determined by the Director; and
                    ``(C) if related to a single occurrence or 
                incident, be given a common identifier to link entries 
                of related data.
            ``(2) Reporting requirements.--The patient safety officer 
        of a Program participant shall be required to prepare and enter 
        into the Database--
                    ``(A) reports, containing only nonidentifiable 
                patient safety work product, filed by a health care 
                provider under subsection (c)(4) and a summary of the 
                findings of the root cause analysis with respect to 
                such report within 5 business days of the completion of 
                the root cause analysis;
                    ``(B) any disciplinary actions taken against a 
                health care provider as a result of involvement in any 
                incident or occurrence involving a patient that is 
                thought to be a medical error or patient safety event, 
                or legal action for which a report under subsection 
                (c)(4) was filed; or
                    ``(C) other data as determined appropriate by the 
                Director.
            ``(3) Privilege and confidentiality.--The provisions of 
        section 922 shall apply to patient safety data submitted under 
        this subsection.

``SEC. 946. THE NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL 
              ERROR REPORTING ACCOUNTABILITY STUDY.

    ``(a) In General.--The Director of the Office shall conduct, 
directly or through a contract with patient safety organizations or 
qualified individuals or institutions, an analysis of the patient 
safety data in the Database and other available data to determine 
performance and systems standards, tools, and best practices (including 
peer review) for doctors and other health care providers necessary to 
prevent medical errors, improve patient safety, and increase 
accountability within the health care system. Such analysis shall also 
consider the value of increasing the transparency of the patient safety 
data to include the identity of health care providers and provide 
recommendations for improvements to the peer review process.
    ``(b) Report and Recommendations.--Not later than 2 years after the 
date of enactment of this section, the Director of the Office shall 
submit to Congress and make available to States, State medical boards, 
and the public a report that describes the results of the study carried 
out under subsection (a) and contains recommendations for Congress 
based on the findings of the report.''.
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