[Congressional Record (Bound Edition), Volume 151 (2005), Part 13]
[House]
[Pages 17774-17780]
[From the U.S. Government Publishing Office, www.gpo.gov]




           PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005

  Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and 
pass the Senate bill (S. 544) to amend title IX of the Public Health 
Service Act to provide for the improvement of patient safety and to 
reduce the incidence of events that adversely effect patient safety.
  The Clerk read as follows:

                                 S. 544

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Patient 
     Safety and Quality Improvement Act of 2005''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

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

                  ``Part C--Patient Safety Improvement

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

     SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

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

                  ``PART C--PATIENT SAFETY IMPROVEMENT

     ``SEC. 921. DEFINITIONS.

       ``In this part:
       ``(1) HIPAA confidentiality regulations.--The term `HIPAA 
     confidentiality regulations' means regulations promulgated 
     under section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
     2033).
       ``(2) Identifiable patient safety work product.--The term 
     `identifiable patient

[[Page 17775]]

     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)

[[Page 17776]]

     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

[[Page 17777]]

       ``(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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Georgia (Mr. Deal) and the gentleman from Ohio (Mr. Brown) each will 
control 20 minutes.
  The Chair recognizes the gentleman from Georgia (Mr. Deal).


                             General Leave

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks and include extraneous material on S. 544, the Senate 
bill now under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  There was no objection.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume, and I rise today in support of S. 544, the Patient Safety and 
Quality Improvement Act of 2005.
  This bill reflects the bipartisan and bicameral agreement of the 
leadership of the Committee on Energy and Commerce and the Senate 
Committee on Health, Education, Labor, and Pensions. The bill is 
identical to H.R. 3205, which was passed by the Committee on Energy and 
Commerce last week.
  In 1999, the Institute of Medicine first identified that up to 98,000 
Americans die every year as a result of preventable medical errors. In 
the report, entitled ``To Err is Human,'' the IOM recommended that 
Congress pass legislation to protect the development and analysis of 
information related to improving safety and quality. The Patient Safety 
and Quality Improvement

[[Page 17778]]

Act of 2005 codifies the principal recommendations made in the IOM 
report.
  This bill will assist in promoting a culture of safety and quality; 
and, more important, it will save lives. The bill encourages providers, 
such as hospitals and physicians, to share information with HHS-
certified patient safety organizations to assess ways in which to 
improve the delivery of health care and reduce medical errors. 
Information regarding patients, providers, and reporters, called 
patient safety work product, would now remain confidential and 
protected.
  Mr. Speaker, the bill fosters open and honest communications among 
providers and patient safety organizations to achieve an environment 
where providers are able to discuss errors openly and learn from them. 
The bill also provides a privilege from disclosing patient safety work 
product in most court or administrative proceedings.
  In addition to enjoying bipartisan support, this bill is also 
supported by providers and consumer groups. These include the American 
Medical Association, the American Hospital Association, the American 
College of Surgeons, and the AARP.
  This new language builds directly on the work of our colleague, the 
gentleman from Florida (Mr. Bilirakis), who worked to develop a 
bipartisan patient safety bill that passed by over 400 votes in the 
last Congress.
  I also want to recognize Senators Enzi and Kennedy; our House ranking 
member, the gentleman from Michigan (Mr. Dingell); and the ranking 
member of the Subcommittee on Health, the gentleman from Ohio (Mr. 
Brown), for their leadership in this effort. They, along with the 
staffs of the House Committee on Energy and Commerce and the Senate 
HELP Committee, deserve our thanks for producing this important 
bipartisan bill.
  I also specifically would like to recognize Andrew Patzman and David 
Bowen from the Senate HELP Committee, along with Bridgett Taylor, 
Purvee Kempf, Nandan Kenkermath, Melissa Bartlett, and Brandon Clark 
for their important help on this bill.
  Mr. Speaker, I yield 5 minutes to the gentleman from Florida (Mr. 
Bilirakis), the original sponsor of this legislation in the past 
Congress and one who has continued to work on it.
  Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me 
this time; and I, too, obviously, support S. 544, which is the exact 
Senate counterpart to H.R. 3205, the legislation on which I and so many 
others have worked for several years to reduce medical errors and save 
lives.
  The landmark 1999 Institute of Medicine report entitled ``To Err is 
Human,'' found that as many as 98,000 people die each year from 
preventable medical errors. The IOM report noted these errors may cost 
taxpayers as much as $29 billion each year, in addition to the 
incalculable pain and suffering experienced by those who lose loved 
ones as a result of them.
  The Patient Safety and Quality Improvement Act will implement many of 
the IOM's recommendations for reducing medical errors. This legislation 
would establish a framework within which providers can voluntarily 
report medical errors to patient safety organizations, which in turn 
would analyze the data and recommend steps providers could take to 
prevent such errors from occurring in the future.
  These patient safety organizations will be empowered to compile 
reports on errors and near-misses, determine the causes of these errors 
or near-errors, identify the changes that need to be made to the health 
care delivery system to prevent these errors in the future, and 
implement needed changes. Their work will be invaluable in identifying 
national trends on medical errors and recommending how to prevent them.
  The legislation encourages providers to share information about 
medical mistakes by preventing the information that they have created 
specifically to report to patient safety organizations from being used 
against them. The bill would preclude this information, termed patient 
safety work product, from being used against providers in civil and 
administrative proceedings, disclosed pursuant to Freedom of 
Information Act requests, or used to carry out adverse personnel 
actions.
  The bill does not shield other information outside this patient 
safety work product from use in court cases. I believe it strikes an 
appropriate balance between encouraging the reporting of valuable 
information, which will be used to save lives, and safeguarding the 
ability of individuals to access necessary information to seek judicial 
redress when appropriate.
  I believe that Congress must pass the Patient Safety and Quality 
Improvement Act to encourage the voluntary reporting of information on 
medical errors. Doing so will help create a culture of awareness to 
expose and address the systemic causes of medical errors instead of 
continuing the culture of blame which hides and perpetuates them.
  Mr. Speaker, I want to thank several individuals: Chairman of the 
Committee on Energy and Commerce, the gentleman from Texas (Mr. 
Barton); and the chairman of the Subcommittee on Health, the gentleman 
from Georgia (Mr. Deal). They have shared my commitment to making 
medical errors as rare as possible and minimizing the hurt they cause 
their families, as have the ranking member, the gentleman from Michigan 
(Mr. Dingell), and the subcommittee ranking member, the gentleman from 
Ohio (Mr. Brown). This indeed has been a true bipartisan effort.
  I also want to thank members of the staff, though the gentleman from 
Georgia (Mr. Deal) already has done so: Nandan Kenkermath and Melissa 
Bartlett, as well as chief counsel Chuck Clapton and health policy 
coordinator Brandon Clark.
  Mr. Speaker, I also want to thank Jeanne Haggerty, Jeremy Allen, and 
Steve Tilton, several former members of my staff, whose previous work 
on this legislation laid the groundwork for its enactment here today. 
All of these individuals, all should be proud their contributions to 
this legislation will ultimately save the lives of many they will never 
know.
  Mr. Speaker, I urge all our colleagues to support the Patient Safety 
and Quality Improvement Act.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
  It is tragic when Americans die prematurely despite modern medicine. 
It is heartbreaking when Americans die because of modern medicine. 
Medical errors take lives, medical errors waste money, and medical 
errors are largely preventable.
  Based on available data, medical errors kill up to 100,000 Americans 
every year. That number, for sure, is a ballpark estimate because we 
know that medical errors are underreported. That is disturbing, but 
hardly surprising. The reality is that the consequences of reporting 
medical errors can be onerous, which deters some who commit or witness 
medical errors from documenting them.
  This legislation is intended to overcome that obstacle. To reduce the 
number of medical errors, we need to understand what causes them and 
address those causes. Accurate and complete information on medical 
errors is the first step. H.R. 3205, or S. 544, creates a secure 
voluntary medical error reporting system. The system is carefully 
crafted to encourage information-sharing without undermining the 
ability of patients to obtain justice when they are harmed and to help 
the health care system identify the root causes of medical errors 
without hindering the prosecution of criminal acts.
  My friend, the gentleman from Florida (Mr. Bilirakis), and I have 
been working on this legislation for several years. I appreciate his 
leadership on this issue, as well as that of the subcommittee chairman, 
the gentleman from Georgia (Mr. Deal), and our ranking member on the 
full committee, the gentleman from Michigan (Mr. Dingell), along with 
the chairman of the full committee, the gentleman from Texas (Mr. 
Barton).
  I would also like to commend committee staff on both sides of the 
aisle for their hard work to reach a solid bipartisan, bicameral 
compromise on this bill. H.R. 3205/S. 544 will strengthen our health 
care system and save

[[Page 17779]]

lives, and I urge my colleagues' support of this measure.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I yield 3 minutes to the gentleman 
from Georgia (Mr. Norwood).
  Mr. NORWOOD. Mr. Speaker, I thank the gentleman for yielding me this 
time, and I rise in support of the Patient Safety and Quality 
Improvement Act of 2005. I am a proud cosponsor of this bill, and I 
know that this is a bill that my good friend, the gentleman from 
Florida (Mr. Bilirakis), has been working on for at least 5 years. And 
so now I am happy to see it finally come to the floor and will become 
law, hopefully.
  Americans have the best doctors and technology in the world; yet it 
is reported every day that more than 250 Americans die because of 
preventable medical errors in hospitals alone. The cost of preventable 
medical errors is estimated between $17 billion and $29 billion 
annually.
  Mr. Speaker, we must acknowledge that any error that causes harm to a 
patient is one too many. While our health care system may never be 
perfect, we must strive for the best care for our Nation's patients. I 
am happy that this legislation begins to improve the ability to connect 
information about errors and near-errors between doctors, researchers, 
and patients.
  However, as I have stated for years, a key step to improving care 
should be also the passage of meaningful patient protections under 
Federal law. When insurers and employees are concerned about the cost 
of health care, the quality of patient care can be jeopardized for the 
bottom line. This breeds improper care, and it breeds medical error.

                              {time}  1230

  In this light, this legislation is an important first step. This bill 
will encourage the creation of patient safety organizations that 
providers will contract with to provide patient safety information to a 
national patient safety database. While I will concede that I wish we 
were mandating more in this legislation about reporting errors and 
getting that information to patients, I stress that this is an 
essential, important first step.
  The bill helps develop a culture of safety that encourages 
information sharing. When an error occurs, it is important to learn 
from it so as to not repeat it. We need to get everyone comfortable 
with reporting errors and near errors, and this bill begins to do just 
that.
  This bill presents us with an opportunity to stand up for patients, 
and I urge all of my colleagues to join us in supporting it.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman 
from Rhode Island (Mr. Kennedy) who has been a strong advocate during 
his several terms in Congress for patient safety and for patients 
generally.
  Mr. KENNEDY of Rhode Island. Mr. Speaker, I would like to thank the 
gentleman from Ohio (Mr. Brown) for his leadership in this area, as 
well as the gentleman from Florida (Mr. Bilirakis) for his, in addition 
to the committee chairman, the gentleman from Texas (Mr. Barton), and 
the ranking member, the gentleman from Michigan (Mr. Dingell).
  Of the many bills we are talking about on the floor this week, this 
is the only one that is really addressing the root problem in our 
health care system. We stand here in the well of the House, all of us 
from both sides of the aisle, pontificating about the high cost of 
care, malpractice rates, access to prescription drugs, or the 
uninsured. All of these are serious problems with big negative impacts 
on people, but these issues are all symptomatic of a real problem in 
health care. Our system is not set up to get the right care at the 
right time to the right people.
  Hundreds of our constituents will die today, tomorrow, and every day 
until we get this right. Millions will be priced out of care until we 
get this right. My friends just mentioned the statistics; the 
equivalent of a jumbo jet crashing every 3 days is how many people we 
lose in our health care system due to inadequate information because 
there is inadequate information technology to make the information 
intraoperable and transparent for all to see so there are not those 
medications that one is being prescribed by one doctor contravening the 
medications that are prescribed by another doctor because no one has an 
electronic medical record.
  This bill is a step in the right direction. It aligns the incentives 
in health care to promote outcomes we want: higher quality, higher 
safety and higher efficiency. We have seen studies where Medicare has 
had a single procedure. That procedure has been done all around the 
country, and even in the markets where it costs us the most, we often 
see where we have the worst outcomes. We have to ask ourselves why is 
it that we are paying for more care and getting less results? This bill 
does a lot to address that problem. We need to learn from our mistakes 
and use them to make better decisions in the future.
  This is a bill that is carefully designed to compromise so we do not 
have a situation where we close down people's right to seek redress for 
those that are seriously and grievously injured in the course of their 
health care.
  I hope this patient safety bill is the tip of the iceberg in what we 
will do to transform health care. We need to pass a strong health care 
information technology bill. This bill was reported out of the 
committee and I think it will go a long way to getting us on that road, 
but I hope that we continue in this legislative session to move us even 
further, where we begin as a country to make our health care system 
come up to the same level of technology as every other area in our 
country is right now.
  It is inconceivable that people can have an ATM card and get 
information or dollars anywhere in the country, and yet they cannot get 
their medical record to the doctor that they need to have that medical 
record so that physician can make the right decision based upon all of 
the information that is there about their background, and that we are 
not having situations where there are drug overdoses because of lack of 
being able to read the orders. As is too often the case, we not only 
have people die, but also seriously injured.
  One instance, a little girl named Josie King in Baltimore was 
seriously scalded when she went into the bathtub and the tub was too 
hot. Her mother took her to the hospital, and she got the best care 
because this country has the best health care in the world. She had the 
best professionals because this country has the best professionals in 
the world. But when it came to the system, the system is what is 
broken, and this system let Josie King down to the point where she was 
given the wrong medication because her physician did not have the right 
information before him. As a result, Josie King was in a coma and 
eventually had to be removed from life support.
  Mr. Speaker, we need to learn from these tragedies if we are to 
prevent them in the future. This legislation moves us down that path. I 
ask my colleagues to support this legislation.
  Mr. DEAL of Georgia. Mr. Speaker, I yield 2 minutes to the gentleman 
from Texas (Mr. Burgess), a member of the Subcommittee on Health.
  Mr. BURGESS. Mr. Speaker, I thank the gentleman for yielding me this 
time, and thank the gentleman from Florida (Mr. Bilirakis) for his 
leadership, and the gentleman from Texas (Chairman Barton), who is 
always evenhanded, played a big role in us finally getting this bill to 
the floor. I thank the ranking member, the gentleman from Ohio (Mr. 
Brown), for his work on this bill as well.
  Mr. Speaker, this is an important bill before us today. As a 
physician, I know that in order to improve safety, we have got to 
report errors. The gentleman from Georgia (Mr. Norwood) just pointed 
out how if you do not report the error, you cannot learn from the 
mistake and never prevent it from happening again.
  We have an environment right now that punishes doctors for perceived 
or actual mistakes by lawsuits and regulation, and it has become nearly 
impossible to encourage true transparency in

[[Page 17780]]

the practice of medicine. This opacity has not served anyone well with 
the possible exception of the plaintiff's bar.
  I am pleased the United States Congress has finally come to an 
agreement on a level-headed approach to error reporting and will set 
quality standards in medicine. I believe this bill will be the first 
assault on the culture of fear that has permeated medicine for years 
now; doctors afraid of making a mistake, or doctors afraid of saying I 
am sorry for fear of being sued no matter how small the mistake, and 
this may lead to underreporting, overtreatment, and repetition of the 
same error again.
  By permitting reporting, this bill takes a critical first step in 
improving the quality of care in this country. The research on patient 
safety unequivocally calls for a learning environment rather than the 
punitive environment that is present in this country.
  Many organizations are currently collecting patient safety data, and 
this bill will give them the legal protections that will allow them to 
review protected information and collaborate on the development and 
implementation of patient safety and improvement strategies.
  Mr. Speaker, this bill is long overdue. I agree with the gentleman 
from Georgia (Mr. Norwood) it is but a first step, but it is an 
important first step, and I am happy to put my support behind this bill 
that will improve the medical profession and improve the quality and 
safety of medical care for all Americans.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, S. 544 is identical to the bill passed out of the 
Committee on Emergency and Commerce, H.R. 3205. Therefore, the 
committee report we will be filing based on H.R. 3205 is directly 
relevant to S. 544. I wanted that part of the Record.
  Mr. DINGELL. Mr. Speaker, in 1999, the Institute of Medicine (IOM) 
reported that as many as 98,000 people are estimated to die annually as 
a result of medical errors. The IOM recommended several changes, 
including the creation of a patient safety reporting system that would 
allow health care service providers to report information about medical 
errors in a non-punitive environment. This information would be 
reviewed by a patient safety organization that would then help 
providers learn from their mistakes without fear of reprisal.
  The Committee has been working for many years on legislation to bring 
forward the building blocks of this system, and in the 108th Congress, 
we successfully passed bipartisan legislation in the House. Only this 
Congress, however, did we successfully reach a compromise with our 
colleagues in the Senate. I am pleased that today we will finally pass 
the Patient Safety and Quality Improvement Act of 2005, with the 
expectation that it will be enacted into law.
  S. 544, the Senate companion bill to H.R. 3205, contains the same 
language as the House bill approved unanimously by the Committee on 
Energy and Commerce last week. The goal of H.R. 3205 is to set up an 
error reporting system for health care providers that brings real 
improvements in patient safety and the quality of health care. It will 
also help ensure accountability by raising standards and creating the 
expectation for continuous quality improvements in patient safety. This 
bill achieves these goals by creating a helpful and non-punitive 
atmosphere for health care providers to share information with entities 
specialized in patient safety and quality improvement. Yet, it 
continues to allow public access to information that is available 
today. Patient safety organizations will receive information about 
medical errors and then evaluate trends, such as infection rates and 
other quality measures, within provider organizations. This will help 
providers learn to avoid such errors in the future.
  This is excellent and important legislation, and I urge its adoption.
  Mr. DOOLITTLE. Mr. Speaker, I rise today to support the legislation 
introduced by my colleague from Vermont which, understandably, enjoys 
bipartisan support.
  Last, year, President Bush called for the majority of Americans to 
have electronic health records within 10 years and established the role 
of the National Coordinator for Health Information Technology to help 
realize this target. The Patient Safety and Quality Improvement Act 
2005 is a critical step toward this important goal and the nation's 
overall vision of providing safer, efficient healthcare for all 
Americans.
  I am proud to report that a healthcare leader in my district is ahead 
of the curve in pursuit of this vision. In response to the need for 
leadership in the area of healthcare information technology, Adventist 
Health--a not-for-profit health care system headquartered in Roseville, 
California--made the decision to invest over $120,000,000 to implement 
a new state-of-the-art Clinical Information System for all their 
hospitals. Project IntelliCare is a ground-breaking, historical 
initiative and an important first step toward fulfilling patients' 
aspirations for safe, effective health care.
  Long before the concept of healthcare information technology was 
being discussed nationally, Adventist Health committed to implementing 
this system-- one of the largest single capital investments the health 
care system has ever made. I think it is extremely important that we 
support this legislation today. By establishing the refining our goals 
in this area with legislation like this, we allow health care providers 
like Adventist Health to easily adapt programs and projects that 
support patient safety and quality.
  It would be my hope--and good public policy--that officials at the 
Department of Health and Human Services reach out to Adventist Health 
officers and solicit their guidance. This guidance would be based on 
the experience of a half a decade of success and challenges. I am proud 
of what Adventist Health is accomplishing in California. I look forward 
working with secretary Leavitt and the Department of Health and Human 
Services to assist in the implementation of Health Information 
Technology on a national level.
  Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I urge the adoption of this bill, 
and I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Culberson). The question is on the 
motion offered by the gentleman from Georgia (Mr. Deal) that the House 
suspend the rules and pass the Senate bill, S. 544.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. DEAL of Georgia. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

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