[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 544 Enrolled Bill (ENR)]


        S.544

                       One Hundred Ninth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
            the fourth day of January, two thousand and five


                                 An Act


 
 To amend title IX of the Public Health Service Act to provide for the 
improvement of patient safety and to reduce the incidence of events that 
                    adversely effect patient safety.

    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 and 
Quality Improvement Act of 2005''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Amendments to Public Health Service Act.

                  ``Part C--Patient Safety Improvement

    ``Sec. 921. Definitions.
    ``Sec. 922. Privilege and confidentiality protections.
    ``Sec. 923. Network of patient safety databases.
    ``Sec. 924. Patient safety organization certification and listing.
    ``Sec. 925. Technical assistance.
    ``Sec. 926. Severability.

SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

    (a) In General.--Title IX of the Public Health Service Act (42 
U.S.C. 299 et seq.) is amended--
        (1) in section 912(c), by inserting ``, in accordance with part 
    C,'' after ``The Director shall'';
        (2) by redesignating part C as part D;
        (3) by redesignating sections 921 through 928, as sections 931 
    through 938, respectively;
        (4) in section 938(1) (as so redesignated), by striking ``921'' 
    and inserting ``931''; and
        (5) by inserting after part B the following:

                  ``PART C--PATIENT SAFETY IMPROVEMENT

``SEC. 921. DEFINITIONS.

    ``In this part:
        ``(1) HIPAA confidentiality regulations.--The term `HIPAA 
    confidentiality regulations' means regulations promulgated under 
    section 264(c) of the Health Insurance Portability and 
    Accountability Act of 1996 (Public Law 104-191; 110 Stat. 2033).
        ``(2) 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 HIPAA 
        confidentiality regulations; 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).
        ``(3) Nonidentifiable patient safety work product.--The term 
    `nonidentifiable patient safety work product' means patient safety 
    work product that is not identifiable patient safety work product 
    (as defined in paragraph (2)).
        ``(4) Patient safety organization.--The term `patient safety 
    organization' means a private or public entity or component thereof 
    that is listed by the Secretary pursuant to section 924(d).
        ``(5) Patient safety activities.--The term `patient safety 
    activities' means the following activities:
            ``(A) Efforts to improve patient safety and the quality of 
        health care delivery.
            ``(B) The collection and analysis of patient safety work 
        product.
            ``(C) The development and dissemination of information with 
        respect to improving patient safety, such as recommendations, 
        protocols, or information regarding best practices.
            ``(D) The utilization of patient safety work product for 
        the purposes of encouraging a culture of safety and of 
        providing feedback and assistance to effectively minimize 
        patient risk.
            ``(E) The maintenance of procedures to preserve 
        confidentiality with respect to patient safety work product.
            ``(F) The provision of appropriate security measures with 
        respect to patient safety work product.
            ``(G) The utilization of qualified staff.
            ``(H) Activities related to the operation of a patient 
        safety evaluation system and to the provision of feedback to 
        participants in a patient safety evaluation system.
        ``(6) Patient safety evaluation system.--The term `patient 
    safety evaluation system' means the collection, management, or 
    analysis of information for reporting to or by a patient safety 
    organization.
        ``(7) Patient safety work product.--
            ``(A) In general.--Except as provided in subparagraph (B), 
        the term `patient safety work product' means any data, reports, 
        records, memoranda, analyses (such as root cause analyses), or 
        written or oral statements--
                ``(i) which--

                    ``(I) are assembled or developed by a provider for 
                reporting to a patient safety organization and are 
                reported to a patient safety organization; or
                    ``(II) are developed by a patient safety 
                organization for the conduct of patient safety 
                activities;

            and which could result in improved patient safety, health 
            care quality, or health care outcomes; or
                ``(ii) which identify or constitute the deliberations 
            or analysis of, or identify the fact of reporting pursuant 
            to, a patient safety evaluation system.
            ``(B) Clarification.--
                ``(i) Information described in subparagraph (A) does 
            not include a patient's medical record, billing and 
            discharge information, or any other original patient or 
            provider record.
                ``(ii) Information described in subparagraph (A) does 
            not include information that is collected, maintained, or 
            developed separately, or exists separately, from a patient 
            safety evaluation system. Such separate information or a 
            copy thereof reported to a patient safety organization 
            shall not by reason of its reporting be considered patient 
            safety work product.
                ``(iii) Nothing in this part shall be construed to 
            limit--

                    ``(I) the discovery of or admissibility of 
                information described in this subparagraph in a 
                criminal, civil, or administrative proceeding;
                    ``(II) the reporting of information described in 
                this subparagraph to a Federal, State, or local 
                governmental agency for public health surveillance, 
                investigation, or other public health purposes or 
                health oversight purposes; or
                    ``(III) a provider's recordkeeping obligation with 
                respect to information described in this subparagraph 
                under Federal, State, or local law.

        ``(8) Provider.--The term `provider' means--
            ``(A) an individual or entity licensed or otherwise 
        authorized under State law to provide health care services, 
        including--
                ``(i) a hospital, nursing facility, comprehensive 
            outpatient rehabilitation facility, home health agency, 
            hospice program, renal dialysis facility, ambulatory 
            surgical center, pharmacy, physician or health care 
            practitioner's office, long term care facility, behavior 
            health residential treatment facility, clinical laboratory, 
            or health center; or
                ``(ii) a physician, physician assistant, nurse 
            practitioner, clinical nurse specialist, certified 
            registered 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; or
            ``(B) any other individual or entity specified in 
        regulations promulgated by the Secretary.

``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.

    ``(a) Privilege.--Notwithstanding any other provision of Federal, 
State, or local law, and subject to subsection (c), patient safety work 
product shall be privileged and shall not be--
        ``(1) subject to a Federal, State, or local civil, criminal, or 
    administrative subpoena or order, including in a Federal, State, or 
    local civil or administrative disciplinary proceeding against a 
    provider;
        ``(2) subject to discovery in connection with a Federal, State, 
    or local civil, criminal, or administrative proceeding, including 
    in a Federal, State, or local civil or administrative disciplinary 
    proceeding against a provider;
        ``(3) subject to disclosure pursuant to section 552 of title 5, 
    United States Code (commonly known as the Freedom of Information 
    Act) or any other similar Federal, State, or local law;
        ``(4) admitted as evidence in any Federal, State, or local 
    governmental civil proceeding, criminal proceeding, administrative 
    rulemaking proceeding, or administrative adjudicatory proceeding, 
    including any such proceeding against a provider; or
        ``(5) admitted in a professional disciplinary proceeding of a 
    professional disciplinary body established or specifically 
    authorized under State law.
    ``(b) Confidentiality of Patient Safety Work Product.--
Notwithstanding any other provision of Federal, State, or local law, 
and subject to subsection (c), patient safety work product shall be 
confidential and shall not be disclosed.
    ``(c) Exceptions.--Except as provided in subsection (g)(3)--
        ``(1) Exceptions from privilege and confidentiality.--
    Subsections (a) and (b) shall not apply to (and shall not be 
    construed to prohibit) one or more of the following disclosures:
            ``(A) Disclosure of relevant patient safety work product 
        for use in a criminal proceeding, but only after a court makes 
        an in camera determination that such patient safety work 
        product contains evidence of a criminal act and that such 
        patient safety work product is material to the proceeding and 
        not reasonably available from any other source.
            ``(B) Disclosure of patient safety work product to the 
        extent required to carry out subsection (f)(4)(A).
            ``(C) Disclosure of identifiable patient safety work 
        product if authorized by each provider identified in such work 
        product.
        ``(2) Exceptions from confidentiality.--Subsection (b) shall 
    not apply to (and shall not be construed to prohibit) one or more 
    of the following disclosures:
            ``(A) Disclosure of patient safety work product to carry 
        out patient safety activities.
            ``(B) Disclosure of nonidentifiable patient safety work 
        product.
            ``(C) Disclosure of patient safety work product to 
        grantees, contractors, or other entities carrying out research, 
        evaluation, or demonstration projects authorized, funded, 
        certified, or otherwise sanctioned by rule or other means by 
        the Secretary, for the purpose of conducting research to the 
        extent that disclosure of protected health information would be 
        allowed for such purpose under the HIPAA confidentiality 
        regulations.
            ``(D) Disclosure by a provider to the Food and Drug 
        Administration with respect to a product or activity regulated 
        by the Food and Drug Administration.
            ``(E) Voluntary disclosure of patient safety work product 
        by a provider to an accrediting body that accredits that 
        provider.
            ``(F) Disclosures that the Secretary may determine, by rule 
        or other means, are necessary for business operations and are 
        consistent with the goals of this part.
            ``(G) Disclosure of patient safety work product to law 
        enforcement authorities relating to the commission of a crime 
        (or to an event reasonably believed to be a crime) if the 
        person making the disclosure believes, reasonably under the 
        circumstances, that the patient safety work product that is 
        disclosed is necessary for criminal law enforcement purposes.
            ``(H) With respect to a person other than a patient safety 
        organization, the disclosure of patient safety work product 
        that does not include materials that--
                ``(i) assess the quality of care of an identifiable 
            provider; or
                ``(ii) describe or pertain to one or more actions or 
            failures to act by an identifiable provider.
        ``(3) Exception from privilege.--Subsection (a) shall not apply 
    to (and shall not be construed to prohibit) voluntary disclosure of 
    nonidentifiable patient safety work product.
    ``(d) Continued Protection of Information After Disclosure.--
        ``(1) In general.--Patient safety work product that is 
    disclosed under subsection (c) shall continue to be privileged and 
    confidential as provided for in subsections (a) and (b), and such 
    disclosure shall not be treated as a waiver of privilege or 
    confidentiality, and the privileged and confidential nature of such 
    work product shall also apply to such work product in the 
    possession or control of a person to whom such work product was 
    disclosed.
        ``(2) Exception.--Notwithstanding paragraph (1), and subject to 
    paragraph (3)--
            ``(A) if patient safety work product is disclosed in a 
        criminal proceeding, the confidentiality protections provided 
        for in subsection (b) shall no longer apply to the work product 
        so disclosed; and
            ``(B) if patient safety work product is disclosed as 
        provided for in subsection (c)(2)(B) (relating to disclosure of 
        nonidentifiable patient safety work product), the privilege and 
        confidentiality protections provided for in subsections (a) and 
        (b) shall no longer apply to such work product.
        ``(3) Construction.--Paragraph (2) shall not be construed as 
    terminating or limiting the privilege or confidentiality 
    protections provided for in subsection (a) or (b) with respect to 
    patient safety work product other than the specific patient safety 
    work product disclosed as provided for in subsection (c).
        ``(4) Limitations on actions.--
            ``(A) Patient safety organizations.--
                ``(i) In general.--A patient safety organization shall 
            not be compelled to disclose information collected or 
            developed under this part whether or not such information 
            is patient safety work product unless such information is 
            identified, is not patient safety work product, and is not 
            reasonably available from another source.
                ``(ii) Nonapplication.--The limitation contained in 
            clause (i) shall not apply in an action against a patient 
            safety organization or with respect to disclosures pursuant 
            to subsection (c)(1).
        ``(B) Providers.--An accrediting body shall not take an 
    accrediting action against a provider based on the good faith 
    participation of the provider in the collection, development, 
    reporting, or maintenance of patient safety work product in 
    accordance with this part. An accrediting body may not require a 
    provider to reveal its communications with any patient safety 
    organization established in accordance with this part.
    ``(e) Reporter Protection.--
        ``(1) In general.--A provider may not take an adverse 
    employment action, as described in paragraph (2), against an 
    individual based upon the fact that the individual in good faith 
    reported information--
            ``(A) to the provider with the intention of having the 
        information reported to a patient safety organization; or
            ``(B) directly to a patient safety organization.
        ``(2) Adverse employment action.--For purposes of this 
    subsection, an `adverse employment action' includes--
            ``(A) loss of employment, the failure to promote an 
        individual, or the failure to provide any other employment-
        related benefit for which the individual would otherwise be 
        eligible; or
            ``(B) an adverse evaluation or decision made in relation to 
        accreditation, certification, credentialing, or licensing of 
        the individual.
    ``(f) Enforcement.--
        ``(1) Civil monetary penalty.--Subject to paragraphs (2) and 
    (3), a person who discloses identifiable patient safety work 
    product in knowing or reckless violation of subsection (b) shall be 
    subject to a civil monetary penalty of not more than $10,000 for 
    each act constituting such violation.
        ``(2) Procedure.--The provisions of section 1128A of the Social 
    Security Act, other than subsections (a) and (b) and the first 
    sentence of subsection (c)(1), shall apply to civil money penalties 
    under this subsection in the same manner as such provisions apply 
    to a penalty or proceeding under section 1128A of the Social 
    Security Act.
        ``(3) Relation to hipaa.--Penalties shall not be imposed both 
    under this subsection and under the regulations issued pursuant to 
    section 264(c)(1) of the Health Insurance Portability and 
    Accountability Act of 1996 (42 U.S.C. 1320d-2 note) for a single 
    act or omission.
        ``(4) Equitable relief.--
            ``(A) In general.--Without limiting remedies available to 
        other parties, a civil action may be brought by any aggrieved 
        individual to enjoin any act or practice that violates 
        subsection (e) and to obtain other appropriate equitable relief 
        (including reinstatement, back pay, and restoration of 
        benefits) to redress such violation.
            ``(B) Against state employees.--An entity that is a State 
        or an agency of a State government may not assert the privilege 
        described in subsection (a) unless before the time of the 
        assertion, the entity or, in the case of and with respect to an 
        agency, the State has consented to be subject to an action 
        described in subparagraph (A), and that consent has remained in 
        effect.
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed--
        ``(1) to limit the application of other Federal, State, or 
    local laws that provide greater privilege or confidentiality 
    protections than the privilege and confidentiality protections 
    provided for in this section;
        ``(2) to limit, alter, or affect the requirements of Federal, 
    State, or local law pertaining to information that is not 
    privileged or confidential under this section;
        ``(3) except as provided in subsection (i), to alter or affect 
    the implementation of any provision of the HIPAA confidentiality 
    regulations or section 1176 of the Social Security Act (or 
    regulations promulgated under such section);
        ``(4) to limit the authority of any provider, patient safety 
    organization, or other entity to enter into a contract requiring 
    greater confidentiality or delegating authority to make a 
    disclosure or use in accordance with this section;
        ``(5) as preempting or otherwise affecting any State law 
    requiring a provider to report information that is not patient 
    safety work product; or
        ``(6) to limit, alter, or affect any requirement for reporting 
    to the Food and Drug Administration information regarding the 
    safety of a product or activity regulated by the Food and Drug 
    Administration.
    ``(h) Clarification.--Nothing in this part prohibits any person 
from conducting additional analysis for any purpose regardless of 
whether such additional analysis involves issues identical to or 
similar to those for which information was reported to or assessed by a 
patient safety organization or a patient safety evaluation system.
    ``(i) Clarification of application of hipaa confidentiality 
regulations to patient safety organizations.--For purposes of applying 
the HIPAA confidentiality regulations--
        ``(1) patient safety organizations shall be treated as business 
    associates; and
        ``(2) patient safety activities of such organizations in 
    relation to a provider are deemed to be health care operations (as 
    defined in such regulations) of the provider.
    ``(j) Reports on Strategies to Improve Patient Safety.--
        ``(1) Draft report.--Not later than the date that is 18 months 
    after any network of patient safety databases is operational, the 
    Secretary, in consultation with the Director, shall prepare a draft 
    report on effective strategies for reducing medical errors and 
    increasing patient safety. The draft report shall include any 
    measure determined appropriate by the Secretary to encourage the 
    appropriate use of such strategies, including use in any federally 
    funded programs. The Secretary shall make the draft report 
    available for public comment and submit the draft report to the 
    Institute of Medicine for review.
        ``(2) Final report.--Not later than 1 year after the date 
    described in paragraph (1), the Secretary shall submit a final 
    report to the Congress.

``SEC. 923. NETWORK OF PATIENT SAFETY DATABASES.

    ``(a) In General.--The Secretary shall facilitate the creation of, 
and maintain, a network of patient safety databases that provides an 
interactive evidence-based management resource for providers, patient 
safety organizations, and other entities. The network of databases 
shall have the capacity to accept, aggregate across the network, and 
analyze nonidentifiable patient safety work product voluntarily 
reported by patient safety organizations, providers, or other entities. 
The Secretary shall assess the feasibility of providing for a single 
point of access to the network for qualified researchers for 
information aggregated across the network and, if feasible, provide for 
implementation.
    ``(b) Data Standards.--The Secretary may determine common formats 
for the reporting to and among the network of patient safety databases 
maintained under subsection (a) of nonidentifiable patient safety work 
product, including necessary work product elements, common and 
consistent definitions, and a standardized computer interface for the 
processing of such work product. To the extent practicable, such 
standards shall be consistent with the administrative simplification 
provisions of part C of title XI of the Social Security Act.
    ``(c) Use of Information.--Information reported to and among the 
network of patient safety databases under subsection (a) shall be used 
to analyze national and regional statistics, including trends and 
patterns of health care errors. The information resulting from such 
analyses shall be made available to the public and included in the 
annual quality reports prepared under section 913(b)(2).

``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.

    ``(a) Certification.--
        ``(1) Initial certification.--An entity that seeks to be a 
    patient safety organization shall submit an initial certification 
    to the Secretary that the entity--
            ``(A) has policies and procedures in place to perform each 
        of the patient safety activities described in section 921(5); 
        and
            ``(B) upon being listed under subsection (d), will comply 
        with the criteria described in subsection (b).
        ``(2) Subsequent certifications.--An entity that is a patient 
    safety organization shall submit every 3 years after the date of 
    its initial listing under subsection (d) a subsequent certification 
    to the Secretary that the entity--
            ``(A) is performing each of the patient safety activities 
        described in section 921(5); and
            ``(B) is complying with the criteria described in 
        subsection (b).
    ``(b) Criteria.--
        ``(1) In general.--The following are criteria for the initial 
    and subsequent certification of an entity as a patient safety 
    organization:
            ``(A) The mission and primary activity of the entity are to 
        conduct activities that are to improve patient safety and the 
        quality of health care delivery.
            ``(B) The entity has appropriately qualified staff (whether 
        directly or through contract), including licensed or certified 
        medical professionals.
            ``(C) The entity, within each 24-month period that begins 
        after the date of the initial listing under subsection (d), has 
        bona fide contracts, each of a reasonable period of time, with 
        more than 1 provider for the purpose of receiving and reviewing 
        patient safety work product.
            ``(D) The entity is not, and is not a component of, a 
        health insurance issuer (as defined in section 2791(b)(2)).
            ``(E) The entity shall fully disclose--
                ``(i) any financial, reporting, or contractual 
            relationship between the entity and any provider that 
            contracts with the entity; and
                ``(ii) if applicable, the fact that the entity is not 
            managed, controlled, and operated independently from any 
            provider that contracts with the entity.
            ``(F) To the extent practical and appropriate, the entity 
        collects patient safety work product from providers in a 
        standardized manner that permits valid comparisons of similar 
        cases among similar providers.
            ``(G) The utilization of patient safety work product for 
        the purpose of providing direct feedback and assistance to 
        providers to effectively minimize patient risk.
        ``(2) Additional criteria for component organizations.--If an 
    entity that seeks to be a patient safety organization is a 
    component of another organization, the following are additional 
    criteria for the initial and subsequent certification of the entity 
    as a patient safety organization:
            ``(A) The entity maintains patient safety work product 
        separately from the rest of the organization, and establishes 
        appropriate security measures to maintain the confidentiality 
        of the patient safety work product.
            ``(B) The entity does not make an unauthorized disclosure 
        under this part of patient safety work product to the rest of 
        the organization in breach of confidentiality.
            ``(C) The mission of the entity does not create a conflict 
        of interest with the rest of the organization.
    ``(c) Review of Certification.--
        ``(1) In general.--
            ``(A) Initial certification.--Upon the submission by an 
        entity of an initial certification under subsection (a)(1), the 
        Secretary shall determine if the certification meets the 
        requirements of subparagraphs (A) and (B) of such subsection.
            ``(B) Subsequent certification.--Upon the submission by an 
        entity of a subsequent certification under subsection (a)(2), 
        the Secretary shall review the certification with respect to 
        requirements of subparagraphs (A) and (B) of such subsection.
        ``(2) Notice of acceptance or non-acceptance.--If the Secretary 
    determines that--
            ``(A) an entity's initial certification meets requirements 
        referred to in paragraph (1)(A), the Secretary shall notify the 
        entity of the acceptance of such certification; or
            ``(B) an entity's initial certification does not meet such 
        requirements, the Secretary shall notify the entity that such 
        certification is not accepted and the reasons therefor.
        ``(3) Disclosures regarding relationship to providers.--The 
    Secretary shall consider any disclosures under subsection (b)(1)(E) 
    by an entity and shall make public findings on whether the entity 
    can fairly and accurately perform the patient safety activities of 
    a patient safety organization. The Secretary shall take those 
    findings into consideration in determining whether to accept the 
    entity's initial certification and any subsequent certification 
    submitted under subsection (a) and, based on those findings, may 
    deny, condition, or revoke acceptance of the entity's 
    certification.
    ``(d) Listing.--The Secretary shall compile and maintain a listing 
of entities with respect to which there is an acceptance of a 
certification pursuant to subsection (c)(2)(A) that has not been 
revoked under subsection (e) or voluntarily relinquished.
    ``(e) Revocation of Acceptance of Certification.--
        ``(1) In general.--If, after notice of deficiency, an 
    opportunity for a hearing, and a reasonable opportunity for 
    correction, the Secretary determines that a patient safety 
    organization does not meet the certification requirements under 
    subsection (a)(2), including subparagraphs (A) and (B) of such 
    subsection, the Secretary shall revoke the Secretary's acceptance 
    of the certification of such organization.
        ``(2) Supplying confirmation of notification to providers.--
    Within 15 days of a revocation under paragraph (1), a patient 
    safety organization shall submit to the Secretary a confirmation 
    that the organization has taken all reasonable actions to notify 
    each provider whose patient safety work product is collected or 
    analyzed by the organization of such revocation.
        ``(3) Publication of decision.--If the Secretary revokes the 
    certification of an organization under paragraph (1), the Secretary 
    shall--
            ``(A) remove the organization from the listing maintained 
        under subsection (d); and
            ``(B) publish notice of the revocation in the Federal 
        Register.
    ``(f) Status of Data After Removal from Listing.--
        ``(1) New data.--With respect to the privilege and 
    confidentiality protections described in section 922, data 
    submitted to an entity within 30 days after the entity is removed 
    from the listing under subsection (e)(3)(A) shall have the same 
    status as data submitted while the entity was still listed.
        ``(2) Protection to continue to apply.--If the privilege and 
    confidentiality protections described in section 922 applied to 
    patient safety work product while an entity was listed, or to data 
    described in paragraph (1), such protections shall continue to 
    apply to such work product or data after the entity is removed from 
    the listing under subsection (e)(3)(A).
    ``(g) Disposition of Work Product and Data.--If the Secretary 
removes a patient safety organization from the listing as provided for 
in subsection (e)(3)(A), with respect to the patient safety work 
product or data described in subsection (f)(1) that the patient safety 
organization received from another entity, such former patient safety 
organization shall--
        ``(1) with the approval of the other entity and a patient 
    safety organization, transfer such work product or data to such 
    patient safety organization;
        ``(2) return such work product or data to the entity that 
    submitted the work product or data; or
        ``(3) if returning such work product or data to such entity is 
    not practicable, destroy such work product or data.

``SEC. 925. TECHNICAL ASSISTANCE.

    ``The Secretary, acting through the Director, may provide technical 
assistance to patient safety organizations, including convening annual 
meetings for patient safety organizations to discuss methodology, 
communication, data collection, or privacy concerns.

``SEC. 926. SEVERABILITY.

    ``If any provision of this part is held to be unconstitutional, the 
remainder of this part shall not be affected.''.
    (b) Authorization of Appropriations.--Section 937 of the Public 
Health Service Act (as redesignated by subsection (a)) is amended by 
adding at the end the following:
    ``(e) Patient Safety and Quality Improvement.--For the purpose of 
carrying out part C, there are authorized to be appropriated such sums 
as may be necessary for each of the fiscal years 2006 through 2010.''.
    (c) GAO Study on Implementation.--
        (1) Study.--The Comptroller General of the United States shall 
    conduct a study on the effectiveness of part C of title IX of the 
    Public Health Service Act (as added by subsection (a)) in 
    accomplishing the purposes of such part.
        (2) Report.--Not later than February 1, 2010, the Comptroller 
    General shall submit a report on the study conducted under 
    paragraph (1). Such report shall include such recommendations for 
    changes in such part as the Comptroller General deems appropriate.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.