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[109th Congress Public Law 41]
[From the U.S. Government Printing Office]

[DOCID: f:publ041.109]

[[Page 423]]

           PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005

[[Page 119 STAT. 424]]

Public Law 109-41
109th Congress

                                 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. <<NOTE: July 29, 2005 -  [S. 544]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Patient Safety and Quality 
Improvement Act of 2005.>> 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) <<NOTE: 42 USC 299b-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) <<NOTE: 42 USC 299c--299c-7.>> by redesignating sections 
        921 through 928, as sections 931 through 938, respectively;
            (4) <<NOTE: 42 USC 299c-7.>> 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. <<NOTE: 42 USC 299b-21.>> 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).

[[Page 119 STAT. 425]]

            ``(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

[[Page 119 STAT. 426]]

                                    ``(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.

[[Page 119 STAT. 427]]

``SEC. 922. <<NOTE: 42 USC 299b-22.>> 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.

[[Page 119 STAT. 428]]

                    ``(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

[[Page 119 STAT. 429]]

                      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.

[[Page 119 STAT. 430]]

                    ``(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. <<NOTE: Public 
        information.>> The Secretary shall make the draft report 
        available for public comment and submit the draft report to the 
        Institute of Medicine for review.

[[Page 119 STAT. 431]]

            ``(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. <<NOTE: 42 USC 299b-23.>> 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. <<NOTE: Public information.>> 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. <<NOTE: 42 USC 299b-24.>> 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 <<NOTE: Deadlines.>> 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.

[[Page 119 STAT. 432]]

                    ``(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

[[Page 119 STAT. 433]]

                    ``(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 <<NOTE: Deadline.>> 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) <<NOTE: Federal 
                Register, publication.>> 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--

[[Page 119 STAT. 434]]

            ``(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. <<NOTE: 42 USC 299b-25.>> 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. <<NOTE: 42 USC 299b-26.>> 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 <<NOTE: 42 USC 299c-6.>> 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.

    Approved July 29, 2005.

LEGISLATIVE HISTORY--S. 544 (H.R. 3205):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 109-197 accompanying H.R. 3205 (Comm. on Energy and 
Commerce).
CONGRESSIONAL RECORD, Vol. 151 (2005):
            July 21, considered and passed Senate.
            July 27, considered and passed House.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 41 (2005):
            July 29, Presidential remarks.

                                  <all>
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