[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3205 Reported in House (RH)]


                                                 Union Calendar No. 117
109th CONGRESS
  1st Session
                                H. R. 3205

                          [Report No. 109-197]

 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 affect patient safety, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 12, 2005

Mr. Bilirakis (for himself, Mr. Deal of Georgia, Mr. Brown of Ohio, and 
 Mr. Waxman) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                             July 27, 2005

 Additional sponsors: Mr. Murphy, Mr. Baird, Mr. Whitfield, Ms. Eshoo, 
Mr. Bishop of Georgia, Mr. Burgess, Mr. Norwood, Mr. Walden of Oregon, 
Mr. Upton, Mrs. Bono, Mrs. Drake, Mr. Gene Green of Texas, Mr. Emanuel, 
                    Mr. Pickering, and Mr. McDermott

                             July 27, 2005

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on July 
                               12, 2005]

_______________________________________________________________________

                                 A BILL


 
 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 affect patient safety, and for other purposes.

    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.
                                                 Union Calendar No. 117

109th CONGRESS

  1st Session

                               H. R. 3205

                          [Report No. 109-197]

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                                 A BILL

 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 affect patient safety, and for other purposes.

_______________________________________________________________________

                             July 27, 2005

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed