[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1784 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 1784

 To amend the Public Health Service Act to promote a culture of safety 
 within the health care system through the establishment of a National 
           Medical Error Disclosure and Compensation Program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 28, 2005

Mrs. Clinton (for herself and Mr. Obama) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to promote a culture of safety 
 within the health care system through the establishment of a National 
           Medical Error Disclosure and Compensation 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 Medical Error Disclosure 
and Compensation Act'' or the ``National MEDiC Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) In 1999, the Institute of Medicine released a report 
        entitled ``To Err is Human'' that found medical errors to be 
        the eighth leading cause of death in the United States, with as 
        many as 98,000 people dying each year as a result of medical 
        errors.
            (2) To reduce deaths and injuries due to medical errors, 
        the health care system must identify and learn how to prevent 
        such errors so that health care quality can be improved.
            (3) The goals of the liability system are to identify 
        causes of medical error, remediate those causes to prevent 
        reoccurrence, and to compensate those injured by medical 
        negligence. Studies have shown, however, that only one medical 
        malpractice claim is filed for every 8 medical injuries, and 
        the average duration of malpractice claim resolution is between 
        4 and 8 years. Thus, the current health care liability system 
        has been found to be an inefficient and sometimes ineffective 
        mechanism for initiating or resolving claims of medical error, 
        medical negligence, or malpractice.
            (4) The current liability system has also been shown to be 
        a deterrent to the timely sharing of information among health 
        care professionals, as well as between health care 
        professionals and patients, which impedes efforts to improve 
        patient safety and quality of care.
            (5) Solutions to the patient safety, litigation, and 
        medical liability insurance problems have been elusive. A 
        middle ground solution that meets the basic needs of all 
        stakeholders including patients, health care providers, 
        insurers, purchasers, and attorneys is desperately needed.
            (6) Some hospital systems and private medical liability 
        insurance companies have adopted a policy of robust disclosure 
        of medical errors, apologies for such errors, and early 
        compensation for patient injury. For example, a Department of 
        Veterans Affairs hospital in Lexington, Kentucky, the 
        University of Michigan Health System, and the private insurer 
        Copic Insurance Company in Colorado have adopted such policies 
        and have reported significantly decreased legal expenses and 
        smaller claim payouts. Overall, these policies have resulted in 
        fewer numbers of malpractice suits being filed, more patients 
        being compensated for injuries, greater patient trust and 
        satisfaction, and significantly reduced administrative and 
        legal defense costs for providers, insurers, and hospitals 
        where such policies are in place.

SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    (a) In General.--Title IX of the Public Health Service Act (42 
U.S.C. 299 et seq.), as amended by the Patient Safety and Quality 
Improvement Act of 2005 (Public Law 109-41), is amended--
            (1) by redesignating part D as part E;
            (2) by redesignating sections 931 through 938 as sections 
        941 through 948, respectively;
            (3) in section 948(1) (as so redesignated), by striking 
        ``931'' and inserting ``941''; and
            (4) by inserting after part C the following:

          ``PART D--MEDICAL ERROR DISCLOSURE AND COMPENSATION

``SEC. 931. DEFINITIONS.

    ``In this part:
            ``(1) Database.--The term `Database' means the National 
        Patient Safety Database established under section 934.
            ``(2) 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 therapist, pharmacist, or other individual 
                health care practitioner; and
                    ``(C) any other health care professional specified 
                in regulations promulgated by the Secretary.
            ``(3) Identifiable patient safety work product.--The term 
        `identifiable patient safety work product' means patient safety 
        work product that--
                    ``(A) is presented in a form and manner that allows 
                the identification of any provider that is a subject of 
                the work product, or any providers that participate in 
                activities that are a subject of the work product;
                    ``(B) constitutes individually identifiable health 
                information as that term is defined in the regulations 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996; 
                or
                    ``(C) is presented in a form and manner that allows 
                the identification of an individual who reported 
                information in the manner specified in section 922(e) 
                or 935.
            ``(4) 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.
            ``(5) Nonidentifiable patient safety work product.--The 
        term `nonidentifiable patient safety work product' has the 
        meaning given such term in section 921.
            ``(6) Office.--The term `Office' means the Office of 
        Patient Safety and Health Care Quality established under 
        section 933, which shall be a certified patient safety 
        organization as defined under part C.
            ``(7) 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 935(e).
            ``(8) 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.
            ``(9) 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.
            ``(10) Patient safety organization.--The term `patient 
        safety organization' has the meaning given such term in section 
        921.
            ``(11) Patient safety work product.--The term `patient 
        safety work product' has the meaning given such term in section 
        921.
            ``(12) Program.--The term `Program' means the National 
        Medical Error Disclosure and Compensation (MEDiC) Program, 
        established under section 935.
            ``(13) Program participant.--The term `Program participant' 
        means a participant that meets the requirements of section 
        935(b).
            ``(14) 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.

``SEC. 932. PURPOSE AND GOALS.

    ``It is the purpose of this part to promote a culture of safety 
within hospitals, health systems, clinics, and other sites of health 
care, through the establishment of a National Medical Error Disclosure 
and Compensation (MEDiC) Program (referred to in this part as the 
`Program'). It shall be a goal of the Program to--
            ``(1) improve the quality of health care by encouraging 
        open communication between patients and health care providers 
        about medical errors and other patient safety events;
            ``(2) reduce rates of preventable medical errors;
            ``(3) ensure patients have access to fair compensation for 
        medical injury due to medical error, negligence, or 
        malpractice; and
            ``(4) reduce the cost of medical liability insurance for 
        doctors, hospitals, health systems, and other health care 
        providers.

``SEC. 933. 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 935;
            ``(3) develop a standardized application to be submitted by 
        interested parties for entry into the Program;
            ``(4) oversee the application process for entry into the 
        Program under section 935 and provide technical assistance to 
        Program applicants and Program participants;
            ``(5) 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;
            ``(6) 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 
        934 to receive nonidentifiable patient safety work product as 
        described in the reporting requirements for Program 
        participants under section 935(c)(10);
            ``(7) 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 934(e);
            ``(8) survey Federal, State, and local requirements for the 
        reporting of patient safety data and work to streamline and 
        reduce duplication of such requirements;
            ``(9) 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;
            ``(10) 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 
        medical error trend reports and other analyses as determined 
        appropriate by the Director on a quarterly basis;
            ``(11) 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;
            ``(12) maintain a publicly accessible Internet website to 
        provide patients and health care providers with information 
        concerning the Program and the Database;
            ``(13) conduct, directly or through a contract, the 
        National MEDiC Accountability Study, as described in section 
        937, the Medical Liability Insurance Study, as described in 
        section 938, and a study to reduce the incidence of lawsuits 
        not related to medical error, as described in section 939; and
            ``(14) 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. 934. NATIONAL PATIENT SAFETY DATABASE.

    ``(a) In General.--The Director of the Office shall, in accordance 
with section 933(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 as described in section 935(e); and
            ``(4) include patient safety data required to be submitted 
        by Program participants as described in section 935(e) 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. 935. NATIONAL MEDICAL ERROR DISCLOSURE AND COMPENSATION (MEDIC) 
              PROGRAM.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Office, shall establish a National Medical Error Disclosure and 
Compensation (MEDiC) 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 rates of preventable medical 
errors, ensure patient access to fair compensation for medical injury 
due to medical error, negligence, or malpractice, and reduce the cost 
of medical liability for doctors, hospitals, health systems, and other 
health care providers.
    ``(b) Eligible Participants.--To be eligible to participate in the 
Program an entity shall--
            ``(1)(A) be a health care provider as defined in section 
        931(2)(A);
            ``(B)(i) provide, in whole or part, medical malpractice 
        insurance for doctors and other designated health care 
        providers, including--
                    ``(I) mutual insurance companies;
                    ``(II) privately held or publically traded 
                liability insurance companies;
                    ``(III) self-insured hospitals;
                    ``(IV) captive insurance companies or providers 
                covered by captive insurance companies; and
                    ``(V) risk-retention groups and any other 
                alternative malpractice insurance mechanisms; or
            ``(ii) in the case of a Program participant that is a 
        medical liability insurer, provide to all, or a subset of, the 
        insured of such insurer, an opportunity to participate in the 
        Program; or
            ``(C) 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;
            ``(2) submit cost analysis statements, in such manner as 
        determined by the Director, for the 2 fiscal years prior to the 
        year of expected entry into the Program at the time of 
        application and at the end of every year of participation in 
        the Program, that outline all real and projected costs and 
        savings related to the liability coverage and legal defense 
        costs of doctors and other health care providers;
            ``(3) allocate an amount equal to not less than 50 percent 
        of the projected annual savings for the first year of 
        participation in the Program, not less than 40 percent of the 
        actual savings reported for the second year, and not less than 
        30 percent of the actual savings reported for the third and 
        each subsequent year of participation to--
                    ``(A) in the case of a Program participant that is 
                a medical liability insurer, the reduction of medical 
                liability premiums for doctors or other designated 
                health care providers as defined in section 931; or
                    ``(B) in the case of a Program participant that is 
                a health care provider as defined in section 931(2)(A), 
                activities that result in the reduction of medical 
                errors or that otherwise improve patient safety;
            ``(4) 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--
                    ``(A) any incident or occurrence involving a 
                patient that is thought to either be a medical error or 
                patient safety event; and
                    ``(B) any legal action related to the medical 
                liability of a health care provider;
            ``(5) ensure that the reports filed under paragraph (4) are 
        submitted to the Database in a standardized format as 
        designated by the Director;
            ``(6) where appropriate, ensure that a root cause analysis 
        of any report submitted to the patient safety officer as 
        described in paragraph (4) is performed within 90 days of the 
        filing of a report under such paragraph;
            ``(7) ensure that if a patient was harmed or injured as the 
        result of a 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 (4)(A) shall be 
        disclosed to the patient not later than 5 business days after 
        the completion of root cause analysis;
            ``(8) disclose information contained in any report 
        submitted to the patient safety officer as described in 
        paragraph (4)(A) upon the request of the patient with respect 
        to whom the report has been filed;
            ``(9) 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--
                    ``(A) negotiate compensation with the patient 
                involved in accordance with subsection (d);
                    ``(B) provide, at the discretion of the health care 
                provider involved, an apology or expression of remorse; 
                and
                    ``(C) share, where practicable, any efforts the 
                health care provider will undertake to prevent 
                reoccurrence; and
            ``(10) prepare and submit entries to the Database as 
        required by the Director of the Office and in accordance with 
        subsection (e).
    ``(d) Negotiations.--
            ``(1) Terms.--If at the time of the 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, a patient elects to enter into an agreement for 
        negotiations with a Program participant as provided for in 
        subsection (c)(9), such negotiations shall, at a minimum, 
        provide for the following:
                    ``(A) The confidentiality of the proceedings.
                    ``(B) An agreement that any apology or expression 
                of remorse by a doctor or other designated health care 
                provider at any time during the negotiations shall be 
                kept confidential and shall not be used in any 
                subsequent legal proceedings as an admission of guilt 
                if such negotiations end without an offer of 
                compensation that is acceptable to both parties.
                    ``(C) Written notification of a patient's right to 
                legal counsel, which shall include an affirmative 
                declaration that no coercive or otherwise inappropriate 
                action was taken to dissuade a patient from utilizing 
                counsel for the negotiations.
            ``(2) Neutral third party mediator.--Both parties may agree 
        to the use of a neutral third party mediator to facilitate the 
        negotiation of the terms of the settlement.
            ``(3) Timeframe for negotiations.--With respect to 
        negotiations under paragraph (1), the parties shall agree that 
        if an agreement on the terms of compensation is not reached 
        within 6 months from the date of the disclosure required under 
        subsection (c)(7) to the patient--
                    ``(A) the patient may proceed directly to the 
                judicial system for a resolution of the issues 
                involved; or
                    ``(B) the parties may sign an extension of the 
                agreement to provide an additional 3-month negotiation 
                period.
            ``(4) Payment.--Upon reaching an agreement under this 
        subsection, the Program participant shall provide the 
        negotiated compensation to the patient within an agreed upon 
        timeframe.
            ``(5) Finality.--Upon receipt of the final payment of the 
        accepted settlement as negotiated under this subsection, the 
        patient shall agree to the final settlement of the incident 
        described in the report and findings of the root cause analysis 
        under subsection (c)(7), and further litigation with respect to 
        such matter shall be prohibited in Federal or State court.
    ``(e) 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) the terms of any agreement reached through 
                negotiations under subsection (d);
                    ``(C) any awards given by a Program participant to 
                a patient as compensation for harm or injury whether 
                obtained through negotiations under subsection (d) or 
                by other means;
                    ``(D) 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
                    ``(E) 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. 936. NATIONAL MEDIC GRANT PROGRAM.

    ``(a) In General.--The Director of the Office shall award grants--
            ``(1) to Program participants, to enable such participants 
        to--
                    ``(A) develop and implement communication programs 
                to help health care providers disclose medical errors 
                and other patient safety events to patients; and
                    ``(B) procure information technology products, 
                including hardware, software, and support services, to 
                facilitate the reporting, collection, and analysis of 
                patient safety data as required under this part; and
            ``(2) to patient safety organizations and qualified 
        institutions or individuals, to enable the--
                    ``(A) tracking and analysis of local and regional 
                patient safety trends; and
                    ``(B) development and dissemination of training 
                guidelines and other recommendations for doctors and 
                other designated health care providers that focus on 
                methods to reduce medical errors and improve patient 
                safety and quality of care.
    ``(b) Application.--To be eligible to receive a grant under this 
section, a Program participant, patient safety organization, or 
qualified institution or individuals shall submit to the Director of 
the Office an application at such time, in such manner, and containing 
such information as the Director may require.
    ``(c) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated, 
        such sums as may be necessary to carry out this section.
            ``(2) Reserves.--The Secretary shall reserve 20 percent of 
        the funds appropriated under paragraph (1) to provide funding 
        to Program participants if the Secretary determines that the 
        total costs of the cases handled under the Program for the year 
        exceed the total costs that would have been incurred if such 
        cases had not been handled under the Program.

``SEC. 937. THE NATIONAL MEDIC 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 the National MEDiC Act, 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.

``SEC. 938. MEDICAL LIABILITY INSURANCE STUDY.

    ``(a) In General.--The Director of the Office shall conduct, 
directly or through contract with patient safety organizations or 
qualified individuals or institutions, an analysis of the medical 
liability insurance market that distinguishes between types of carriers 
to determine historic and current legal costs related to medical 
liability, factors leading to increased legal costs related to medical 
liability, and which, if any, State medical liability insurance reforms 
have led to stabilization or reduction in medical liability premiums.
    ``(b) Report and Recommendations.--Not later than 2 years after the 
date of enactment of the National MEDiC Act, the Director of the Office 
shall submit to Congress and make available to the States, State 
insurance regulators, 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.

``SEC. 939. STUDY TO REDUCE THE INCIDENCE OF LAWSUITS NOT RELATED TO 
              MEDICAL ERROR.

    ``(a) In General.--The Director of the Office shall conduct, 
directly or through a contract with patient safety organizations or 
qualified individuals and institutions, an analysis of the patient 
safety data in the Database to examine cases that were not successfully 
negotiated through the Program, or of which the parties (including 
providers and patients) chose not to participate in the Program and to 
determine the reasons, trends, and impact on the Program participants 
and patients.
    ``(b) Report and Recommendations.--
            ``(1) In general.--Not later than 5 years after the date of 
        enactment of the National MEDiC Act, the Director of the Office 
        shall submit to Congress and make available to the States, 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.
            ``(2) Interim reports.--The Director of the Office shall 
        submit periodic interim reports to Congress (and make such 
        reports available to the States and the public) before the 
        submission on the report under paragraph (1) that describes the 
        progress and findings made in carrying out the study under 
        subsection (a).

``SEC. 940. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated, such sums as may be 
necessary to carry out this part.''.
    (b) Conforming Amendment.--Section 921(7)(A)(i)(II) is amended by 
inserting ``, including activities under section 935(e)'' after 
``patient safety activities''.
                                 <all>