[House Report 109-197]
[From the U.S. Government Publishing Office]



109th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    109-197

======================================================================
 
           PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005

                                _______
                                

 July 27, 2005.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 3205]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3205) 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, having considered the 
same, report favorably thereon with an amendment and recommend 
that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     9
Background and Need for Legislation..............................     9
Hearings.........................................................     9
Committee Consideration..........................................    10
Committee Votes..................................................    10
Committee Oversight Findings.....................................    10
Statement of General Performance Goals and Objectives............    10
New Budget Authority, Entitlement Authority, and Tax Expenditures    10
Committee Cost Estimate..........................................    10
Congressional Budget Office Estimate.............................    10
Federal Mandates Statement.......................................    13
Advisory Committee Statement.....................................    13
Constitutional Authority Statement...............................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    18

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.

                          Purpose and Summary

    H.R. 3205 is intended to help create a ``culture of 
safety'' by providing peer review protections for information 
reported on health care errors for the purposes of quality 
improvement and patient safety.

                  Background and Need for Legislation

    In its 1999 report, To Err Is Human, the Institute of 
Medicine (IOM) estimated that 44,000 to 98,000 Americans die 
each year as a result of medical errors; however, providers 
have little to no incentive to report or analyze errors to 
improve the quality of health care. The IOM offered several 
recommendations to improve patient safety and reduce medical 
errors, including that Congress pass legislation to extend peer 
review protections to data related to patient safety and 
quality improvement that are developed and analyzed by health 
care organizations for internal use or shared with others 
solely for the purposes of improving safety and quality.
    This bill is intended to encourage the reporting and 
analysis of medical errors and health care systems by providing 
peer review protection of information reported to patient 
safety organizations for the purposes of quality improvement 
and patient safety. These protections will facilitate an 
environment in which health care providers are able to discuss 
errors openly and learn from them. The protections apply to 
certain categories of documents and communications termed 
``patient safety work product'' that are developed in 
connection with newly created patient safety organizations. 
This patient safety work product is considered privileged and, 
therefore, cannot be subject to disclosures in certain civil, 
criminal, administrative, and disciplinary proceedings or 
disclosed pursuant to the Freedom of Information Act.
    Patient safety organizations will analyze information 
reported from providers and disseminate information back to 
providers in effort to improve quality and patient safety. 
Providers will work with patient safety organizations to 
determine the causes of these errors, identify what changes 
need to be made to prevent these errors, and then implement 
these changes.
    These new protections do not, however, prevent a provider 
from complying with authorized requests for information that 
has been collected, developed, maintained, or exists separately 
from a patient safety evaluation system. Additionally, all 
original patient or provider records are not patient safety 
work product. In general, information that is available to the 
public today will continue to be available.
    The Patient Safety and Quality Improvement Act requires the 
Secretary of Health and Human Services (HHS) to facilitate the 
creation of a network of databases to analyze health care 
errors.

                                Hearings

    On Thursday, June 9, 2005, the Subcommittee on Health held 
an oversight hearing entitled ``Patient Safety and Quality 
Initiatives.'' The subcommittee received testimony from Dr. 
Carolyn M. Clancy, Director, Agency for Healthcare Research and 
Quality; Dr. Dennis O'Leary, President, Joint Commission on 
Accreditation of Healthcare Organizations; Dr. F. Dean Griffen, 
MD, FACS, American College of Surgeons; Dr. William A. 
Bornstein, MD, PhD, Medical Association of Georgia; and, Dr. 
Jane Loewenson, Director, Health Policy, National Partnership 
for Women & Families.

                        Committee Consideration

    On Thursday, July 14, 2005, the Subcommittee on Health met 
in open markup session and approved H.R. 3205 for full 
Committee consideration, by a voice vote, a quorum being 
present. On Wednesday, July 20, 2005, the full Committee met in 
open markup session and ordered H.R. 3205 favorably reported to 
the House, amended, by a voice vote, a quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 3205 reported. A motion by Mr. Barton to order H.R. 3205 
reported to the House, amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of H.R. 3205 is to provide for a health care error 
reporting system that both protects information and improves 
patient safety and the quality of health care, and to ensure 
accountability by raising standards and expectation for 
continuous quality improvements in patient safety.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
3205, the Patient Safety and Quality Improvement Act, would 
result in no new or increased budget authority, entitlement 
authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 27, 2005.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 3205, the Patient 
Safety and Quality Improvement Act of 2005.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                      Elizabeth M. Robinson
                               (For Douglas Holtz-Eakin, Director).
    Enclosure.

H.R. 3205--Patient Safety and Quality Improvement Act of 2005

    Summary: H.R. 3205 would establish certification procedures 
for patient safety organizations (PSOs) and require the 
Secretary of Health and Human Services to maintain a list of 
certified PSOs. Those PSOs would collect patient safety data 
voluntarily submitted by health care providers for inclusion in 
a network of databases. The bill would require the Secretary to 
develop a uniform database, establish national standards for 
the collection and maintenance of patient safety data, and 
provide technical assistance to PSOs. The bill also would 
establish privacy protections and impose civil monetary 
penalties for violations of those protections. The bill would 
require two reports, including a report by the Government 
Accountability Office (GAO) on the overall effectiveness of the 
program and a report by the Secretary on effective strategies 
for increasing patient safety.
    CBO estimates that implementing H.R. 3205 would cost $5 
million in 2006 and $58 million over the 2006-2010 period, 
assuming the appropriation of the necessary amounts. CBO 
estimates that receipts from fines for violation of the privacy 
protections, which are recorded as federal revenues, would 
amount to less than $500,000 a year.
    H.R. 3205 would preempt state laws that govern the 
disclosure of information provided to patient safety 
organizations. While that preemption would be an 
intergovernmental mandate as defined in the Unfunded Mandates 
Reform Act (UMRA), it would impose no requirements on states 
that would result in additional spending; thus, the threshold 
established by UMRA would not be exceeded ($62 million in 2005, 
adjusted annually for inflation).
    The bill would impose a private-sector mandate on health 
care providers, as defined in UMRA, by not allowing them to use 
the fact that an employee reported patient safety data in an 
adverse employment action against an employee. That mandate 
would not have any direct cost, however, because patient safety 
data as defined in the bill does not exist under current law.
    Estimated cost to the Federal Government: The estimated 
cost of H.R. 3205 is shown in the following table. The bill 
could also result in an increase in revenues from fines, but 
CBO estimates that any such increase would be less than 
$500,000 a year. The costs of this legislation fall within 
budget functions 550 (health) and 800 (general government).

------------------------------------------------------------------------
                                      By fiscal year, in millions of
                                                 dollars--
                                 ---------------------------------------
                                   2006    2007    2008    2009    2010
------------------------------------------------------------------------
              CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated authorization level...      15      13      14      14      14
Estimated outlays...............       5      11      14      14      14
------------------------------------------------------------------------

Basis of estimate

            Spending subject to appropriation
    H.R. 3205 would expand the current duties of the Agency for 
Healthcare Research and Quality (AHRQ). Although not 
specifically named, the AHRQ is the most likely agency within 
the Department of Health and Human Services to carry out the 
provisions of the bill. The new duties would include providing 
technical assistance to PSOs that have (or are developing) 
systems for reporting medical errors. AHRQ also would oversee 
the certification and listing of PSOs, which collect patient 
safety data from health care providers. (PSOs are private or 
public organizations that conduct activities to improve patient 
safety and the quality of health care delivery.) PSOs would not 
receive funding under this bill.
    In addition, the bill would require AHRQ to develop and 
maintain a network of databases to collect, support, and 
coordinate the analysis of patient safety data that is reported 
on a voluntary basis. Based on information from AHRQ, CBO 
expects that these tasks would require increased staff for 
providing assistance to PSOs, oversight of PSOs, and 
maintenance of the patient safety database. CBO estimates that 
the agency would need appropriations of$15 million in 2006 and 
about $70 million over the 2006-2010 period to carry out those 
responsibilities. We estimate that the agency would spend about $5 
million in 2006 (primarily on the development of the patient safety 
database) and $58 million over the 2006-2010 period, assuming the 
necessary amounts are appropriated.
            Revenues
    Because those prosecuted and convicted for violation of the 
bill's privacy provisions could be subject to civil monetary 
penalties, the federal government might collect additional 
fines if the bill is enacted. Collections of civil fines are 
recorded in the budget as governmental receipts (i.e., 
revenues). CBO estimates that any additional receipts would be 
less than $500,000 a year.
    Estimated Impact on State, Local, and Tribal Governments: 
H.R. 3205 would preempt any state freedom of information law or 
other laws governing subpoena power or civil or administrative 
procedure that require the disclosure of information provided 
by a health care provider to a certified patient safety 
organization. That preemption would be an intergovernmental 
mandate as deemed in UMRA because it would limit the 
application of those state laws. The bill also would establish 
a number of exceptions to the preemption of state and local 
laws, thus narrowing the scope of the mandate. CBO estimates 
that this mandate would impose no requirement on states that 
would result in additional spending; thus, the threshold as 
established by UMRA would not be exceeded ($62 million in 2005, 
adjusted annually for inflation).
    Estimated Impact on the Private Sector: The bill would 
impose a private-sector mandate on health care providers, as 
deemed in UMRA, by not allowing them to use the fact that an 
employee reported patient safety data in an adverse employment 
action against the employee. This mandate would not have any 
direct cost, however, because patient safety data as defined in 
the bill does not exist under current law.
    Previous CBO estimate: On March 31, 2005, CBO transmitted 
an estimate for S. 544, the Patient Safety and Quality 
Improvement Act of 2005, as ordered reported by the Senate 
Committee on Health, Education, Labor, and Pensions. The scope 
of work under S. 544 is similar to H.R. 3205, and CBO's two 
cost estimates are nearly identical.
    Estimate prepared by: Federal Costs: Julia M. Christensen 
and Camite Williams. Impact on State, Local, and Tribal 
Governments: Leo Lex. Impact on the Private Sector: Peter 
Richmond.
    Estimate Approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title as the ``Patient 
Safety and Quality Improvement Act of 2005.''

Section 2. Amendments to the Public Health Service Act

    Section 2(a) would establish a new Part C in Title IX of 
the Public Health Service Act to encourage a voluntary 
reporting system for patient safety data as set out below.
            Section 921. Definitions
    The bill would add a new section 921 to identify and define 
the elements of a new voluntary reporting system, including the 
terms ``identifiable information,'' ``non-identifiable 
information,'' ``patient safety activities,'' ``patient safety 
evaluation system,'' ``patient safety organization,'' ``patient 
safety work product,'' and ``provider.''
    The definition of patient safety work product contains 
several parts,and a document or communication is patient safety 
work product if it falls into any of the categories in clauses 
(7)(A)(i)-(iii). A document may be patient safety work product for 
multiple reasons. For example, a patient safety organization may 
prepare a memorandum describing its request for further collection of 
information from the reporting provider. The memorandum of the patient 
safety organization is both a document developed by the patient safety 
organization and a document that would identify the deliberations of a 
patient safety evaluation system. A memorandum of the provider that 
identifies the deliberations of a patient safety evaluation system 
would also be patient safety work product.
    Paragraphs 7(B)(i) and (ii) explains documents or 
communications that are not included under clause (7)(A). The 
Committee understands that it is likely and appropriate for a 
provider to keep a copy of documents and possible logs of 
communications that are reported to the patient safety 
organization. Generally, such copies are also patient safety 
work product because they are part of the patient safety 
evaluation system. Such items would not be considered original 
provider records as set out under 7(B)(i).
    On the other hand, there may be documents or communications 
that are part of traditional health care operations or record 
keeping (including but not limited to medical records, billing 
records, guidance on procedures, physician notes, hospital 
policies, logs of operations, records of drug deliveries, and 
primary information at the time of events). Such information 
may be in communications or copies of documents sent to a 
patient safety organization. Originals or copies of such 
documents are both original provider records and separate 
information that is developed, collected, maintained or exist 
separately from any patient safety evaluation system. Both 
these original documents and ordinary information about health 
care operations may be relevant to a patient safety evaluation 
system but are not themselves patient safety work product.
    Once something is patient safety work product, a person may 
disclose such work product for a variety of purposes under 
subsection 922(c). Subsection 922(d) provides that, despite 
such a disclosure, such work product remains confidential and 
privileged and does not lose its status as patient safety work 
product. Thus, clause 921(7)(B)(ii) would not operate to change 
the status of the patient safety work product in this 
circumstance. For example, assume material otherwise meets the 
definition of patient safety work product. If the provider 
voluntarily discloses such work product to an accrediting 
organization under subsection 922(c)(2)(E), the privileged and 
confidential nature of the work product remains.
    On the other hand, nothing requires a provider to disclose 
such patient safety work product to an accrediting 
organization. A provider may choose to collect, develop, or 
maintain information separately from a patient safety 
evaluation system. That separate information or analysis may be 
similar or identical in substance or subject matter to patient 
safety work product. A provider may choose this route in 
disclosing such separate material to an accrediting 
organization.
    A similar approach would apply to material given to 
researchers or for patient safety activities. Information 
provided for research or patient safety activities may be 
patient safety work product or it may not be patient safety 
work product.
    There is further discussion of the term ``patient safety 
work product'' in the context of section 922.
            Section 922. Privilege and confidentiality protections
    New subsection 922(a) creates a privilege for patient 
safety work product for certain proceedings and forums. 
Paragraphs 922(c)(1) and (3) contain exceptions to the 
prohibitions in 922(a). Nothing in this legislation changes 
other requirements that may exist for evidence.
    Here are a few examples of the privilege. Assume a trial 
lawyer asks a provider what communications has the provider had 
with other parties concerning the medical procedures that took 
place during the month of August 2006. Communications that 
identify or constitute the deliberations of or analyses of, or 
identify the fact or reporting to, a patient safety evaluation 
system under 921(7)(A)(ii) are patient safety work product. 
Such information would not be discoverable. Communications with 
other parties, however, would be discoverable.
    Assume a trial lawyer asks what a specific practitioner 
understood about how a certain piece of medical equipment 
operated. Even if this same information was reported to a 
patient safety organization, such information ``exists 
separately'' from a patient safety evaluation system under 
921(7)(B)(ii). Under such a circumstance, the provider should 
respond to the interrogatory but not reveal that similar or the 
same information was being reviewed within the context of a 
patient safety evaluation system.
    Assume an expert analysis is relevant to a legal proceeding 
and a patient safety organization had developed such an 
analysis. The fact that a patient safety organization has 
developed such an analysis does not mean a party could not 
obtain a separate analysis on the same subject matter from a 
different expert or prepare a separate analysis on the same 
subject matter in-house. Such analysis may be separate from a 
patient safety evaluation system both under the meaning of 
921(7)(b)(ii) and under 922(h).
    New subsection 922(b) provides that patient safety work 
product shall not be disclosed except as provided for in 
922(c)(1) and (2). A person may rely on any of the exceptions 
to justify a permissible disclosure. The same disclosure may 
fall under multiple exceptions. For example, patient safety 
work product may be provided, under appropriate circumstances, 
to a researcher under multiple exceptions, including but not 
limited to 922(c)(2)(C).
    There are more exceptions to 922(b) under subsection (c) 
than thereare to 922(a). For example, a discovery order cannot 
request the dates of meetings held between a patient safety 
organization and other parties. On the other hand, schedulers for 
parties may disclose dates of such individual meetings relevant to that 
party for ordinary purposes such as contacting other schedulers, 
setting out travel vouchers, or other purposes. Such disclosure could 
be a disclosure of patient safety work product under 922(c)(2)(H). Such 
a disclosure would neither assess the quality of care of an 
identifiable provider nor describe or pertain to one or more actions or 
failures to act by an identifiable provider.
    Subsection 922(d)(1) states that the fact of disclosure of 
information under one of the exceptions under subsection (c) 
shall not be treated as a waiver of privilege or 
confidentiality. Nor can such a disclosure change the 
privileged or confidential status of such work product.
    Subparagraph 922(d)(4)(A) provides that 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. This 
limitation does not apply to actions against the patient safety 
organization or with respect to disclosures under subsection 
(c)(1). The basic idea is that patient safety organizations may 
be collecting or developing material that is based on 
underlying material that is available at the provider's office 
or through another party. In such circumstances, discovery 
orders should be made to other parties and not the patient 
safety organization.
    Subsection (e) sets out protections for individuals who in 
good faith report information to providers, with the intent 
that the information is reported to a patient safety 
organization, or who report directly to a patient safety 
organization. A provider may not use the fact that an 
individual reported to a patient safety organization or that 
provider against the individual in any adverse employment 
action.
    Paragraph (f)(1) provides monetary penalties for a knowing 
or reckless violation of subsection (b). Subsection 922(a) is 
not enforceable under paragraph (f)(1) but rather should be 
administered in the context of the relevant proceeding. To be 
held liable under paragraph (f)(1) a person should at least 
know, or be reckless in not knowing, that the information was 
indeed confidential patient safety work product.
    Paragraph (f)(3) provides that penalties shall not be 
imposed under (f)(1) and pursuant to HIPAA confidentiality 
regulations for a single act or omission.
    Under paragraph (g)(3) the provisions of the HIPAA 
confidentiality regulations continue to apply, except as 
provided in subsection (i).
    Under paragraph (g)(4), providers, patient safety 
organizations, or other entities, can enter contracts that 
increase confidentiality or restrict the use of information for 
purposes of the relationship between the contracting parties, 
so long as the contracts do not conflict with this Act or any 
other laws. Parties may also, by contract, delegate the 
authority to make an authorized disclosure that is otherwise 
permissible under the Act for that person.
    Paragraph (g)(5) is a savings clause concerning state 
reporting requirements. State reporting requirements cannot 
require reporting of patient safety work product but can 
require reporting of primary medical information and other 
documents or communications that are not patient safety work 
product. Such reporting requirements may even require providers 
to produce reports that are similar in basic function to 
reports being provided to a patient safety organization. 
However, patient safety work product itself, as defined in this 
Act, remains privileged.
    Subsection (h) was discussed in part above. 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. Such 
additional analysis is separate and not patient safety work 
product.
    Under subsection (i) a patient safety organization shall be 
treated as a business associate for purposes of section 264(c) 
of HIPAA. The patient safety activities of such organization 
are deemed to be health care operations of the provider. A 
patient safety organization can be a covered entity for other 
purposes, but also a business associate in its role as a 
patient safety organization.
    Subsection (j) requires the Secretary to provide a report 
on effective strategies for reducing medical errors and 
increasing patient safety.
            Section 923. Network of patient safety databases
    New section 923 requires the Secretary to 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 Secretary may establish common formats for reporting 
data to and among the network of patient safety databases to 
enable ease of use and communication to and among the 
databases. The Secretary should build upon existing databases 
and work already done by the Office of the National Coordinator 
for Health Information Technology and other parts of the 
Department in an effort to maximize the efficiency and utility 
of common data collection efforts across agencies.
    Each database in the network shall be able to accept 
nonidentifiable information, aggregate all the nonidentifiable 
information within the network, and analyze such information. 
The Secretary shall make the information available to 
providers, patient safety organizations and the public and, if 
feasible, the Secretary shall also provide for implementation 
of a single point of access to the individual and aggregated 
data in the network of databases.
            Section 924. Certification of patient safety organizations
    Subsection (a) of new section 924 sets out certain 
requirements for initial and subsequent certifications for 
patient safety organizations. Paragraph (b)(1) sets out 
criteria a patient safety organization must meet as conditions 
of certification. New paragraph 924(b)(2) sets out certain 
additional requirements for patient safety organizations that 
are components of other organizations. Subsection (c) provides 
procedures for the review of certifications. Subsection (d) 
provides for the listing of certifications that have been 
accepted and not revoked. Subsection (e) provides for 
revocation procedures for certain causes. Subsection (f) 
maintains the confidential and privileged status of information 
even where a patient safety organizations listing has been 
revoked.
            Section 925. Technical assistance
    New section 925 states that the Secretary may provide 
certain technical assistance to patient safety organizations.
            Section 926. Severability
    New section 926 provides that if any provision of this part 
is held to be unconstitutional, the remainder of this part 
shall not be affected.
    Subsection (2)(b) of the Act would modify existing section 
937 of the Public Health Service Act to authorize such sums as 
may be necessary for each of the fiscal years 2006-2010.
    Subsection (2)(c) of the Act provides for study from the 
General Accounting Office regarding implementation of the Act.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *



TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

           *       *       *       *       *       *       *


PART B--HEALTH CARE IMPROVEMENT RESEARCH

           *       *       *       *       *       *       *


SEC. 912.  PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND 
                    DELIVERY.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Reducing Errors in Medicine.--The Director shall, in 
accordance with part C, conduct and support research and build 
private-public partnerships to--
          (1) * * *

           *       *       *       *       *       *       *


                   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.

                     PART [C] D--GENERAL PROVISIONS

SEC. [921] 931. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [922] 932. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [923] 933. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, 
                    COLLECTION, AND DISSEMINATION OF DATA.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [924] 934. DISSEMINATION OF INFORMATION.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [925] 935.  ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND 
                    CONTRACTS.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [926] 936. CERTAIN ADMINISTRATIVE AUTHORITIES.

  (a) * * *

           *       *       *       *       *       *       *


SEC. [927] 937. FUNDING.

  (a) * * *

           *       *       *       *       *       *       *

  (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.

SEC. [928] 938. DEFINITIONS.

  In this title:
          (1) Advisory council.--The term ``Advisory Council'' 
        means the National Advisory Council on Healthcare 
        Research and Quality established under section [921] 
        931.

           *       *       *       *       *       *       *


                                  
