IB 

Union Calendar No. 117 

109TH CONGRESS 

1ST SESSION H. R. 3205 

[Report No. 109–197] 

To amend title IX of the Public Health Service Act to provide for the 

improvement of patient safety and to reduce the incidence of events 

that adversely affect patient safety, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 12, 2005 

Mr. BILIRAKIS (for himself, Mr. DEAL of Georgia, Mr. BROWN of Ohio, and 

Mr. WAXMAN) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

JULY 27, 2005 

Additional sponsors: Mr. MURPHY, Mr. BAIRD, Mr. WHITFIELD, Ms. ESHOO, 

Mr. BISHOP of Georgia, Mr. BURGESS, Mr. NORWOOD, Mr. WALDEN of 

Oregon, Mr. UPTON, Mrs. BONO, Mrs. DRAKE, Mr. GENE GREEN of 

Texas, Mr. EMANUEL, Mr. PICKERING, and Mr. MCDERMOTT

JULY 27, 2005 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on July 12, 2005] 

A BILL 

To amend title IX of the Public Health Service Act to 

provide for the improvement of patient safety and to 
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reduce the incidence of events that adversely affect patient safety, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the ‘‘Pa5 tient Safety and Quality Improvement Act of 2005’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 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. 

8 SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT. 

9 (a) IN GENERAL.—Title IX of the Public Health Serv10 ice Act (42 U.S.C. 299 et seq.) is amended— 

11 (1) in section 912(c), by inserting ‘‘, in accord12 ance with part C,’’ after ‘‘The Director shall’’; 

13 (2) by redesignating part C as part D; 

14 (3) by redesignating sections 921 through 928, as 

15 sections 931 through 938, respectively; 

16 (4) in section 938(1) (as so redesignated), by 

17 striking ‘‘921’’ and inserting ‘‘931’’; and 

18 (5) by inserting after part B the following: 
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1 ‘‘PART C—PATIENT SAFETY IMPROVEMENT 

2 ‘‘SEC. 921. DEFINITIONS. 

3 ‘‘In this part: 

4 ‘‘(1) HIPAA CONFIDENTIALITY REGULATIONS.— 

5 The term ‘HIPAA confidentiality regulations’ means 

6 regulations promulgated under section 264(c) of the 

7 Health Insurance Portability and Accountability Act 

8 of 1996 (Public Law 104–191; 110 Stat. 2033). 

9 ‘‘(2) IDENTIFIABLE PATIENT SAFETY WORK

10 PRODUCT.—The term ‘identifiable patient safety work 

11 product’ means patient safety work product that— 

12 ‘‘(A) is presented in a form and manner 

13 that allows the identification of any provider 

14 that is a subject of the work product, or any pro15 viders that participate in activities that are a 

16 subject of the work product; 

17 ‘‘(B) constitutes individually identifiable 

18 health information as that term is defined in the 

19 HIPAA confidentiality regulations; or 

20 ‘‘(C) is presented in a form and manner 

21 that allows the identification of an individual 

22 who reported information in the manner speci23 fied in section 922(e). 

24 ‘‘(3) NONIDENTIFIABLE PATIENT SAFETY WORK

25 PRODUCT.—The term ‘nonidentifiable patient safety 

26 work product’ means patient safety work product that 
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1 is not identifiable patient safety work product (as de2 fined in paragraph (2)). 

3 ‘‘(4) PATIENT SAFETY ORGANIZATION.—The term 

4 ‘patient safety organization’ means a private or pub5 lic entity or component thereof that is listed by the 

6 Secretary pursuant to section 924(d). 

7 ‘‘(5) PATIENT SAFETY ACTIVITIES.—The term 

8 ‘patient safety activities’ means the following activi9 ties: 

10 ‘‘(A) Efforts to improve patient safety and 

11 the quality of health care delivery. 

12 ‘‘(B) The collection and analysis of patient 

13 safety work product. 

14 ‘‘(C) The development and dissemination of 

15 information with respect to improving patient 

16 safety, such as recommendations, protocols, or 

17 information regarding best practices. 

18 ‘‘(D) The utilization of patient safety work 

19 product for the purposes of encouraging a culture 

20 of safety and of providing feedback and assist21 ance to effectively minimize patient risk. 

22 ‘‘(E) The maintenance of procedures to pre23 serve confidentiality with respect to patient safe24 ty work product. 
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1 ‘‘(F) The provision of appropriate security 

2 measures with respect to patient safety work 

3 product. 

4 ‘‘(G) The utilization of qualified staff. 

5 ‘‘(H) Activities related to the operation of a 

6 patient safety evaluation system and to the pro7 vision of feedback to participants in a patient 

8 safety evaluation system. 

9 ‘‘(6) PATIENT SAFETY EVALUATION SYSTEM.— 

10 The term ‘patient safety evaluation system’ means the 

11 collection, management, or analysis of information 

12 for reporting to or by a patient safety organization. 

13 ‘‘(7) PATIENT SAFETY WORK PRODUCT.— 

14 ‘‘(A) IN GENERAL.—Except as provided in 

15 subparagraph (B), the term ‘patient safety work 

16 product’ means any data, reports, records, 

17 memoranda, analyses (such as root cause anal18 yses), or written or oral statements— 

19 ‘‘(i) which— 

20 ‘‘(I) are assembled or developed by 

21 a provider for reporting to a patient 

22 safety organization and are reported to 

23 a patient safety organization; or 
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1 ‘‘(II) are developed by a patient 

2 safety organization for the conduct of 

3 patient safety activities; 

4 and which could result in improved patient 

5 safety, health care quality, or health care 

6 outcomes; or 

7 ‘‘(ii) which identify or constitute the 

8 deliberations or analysis of, or identify the 

9 fact of reporting pursuant to, a patient 

10 safety evaluation system. 

11 ‘‘(B) CLARIFICATION.— 

12 ‘‘(i) Information described in subpara13 graph (A) does not include a patient’s med14 ical record, billing and discharge informa15 tion, or any other original patient or pro16 vider record. 

17 ‘‘(ii) Information described in sub18 paragraph (A) does not include information 

19 that is collected, maintained, or developed 

20 separately, or exists separately, from a pa21 tient safety evaluation system. Such sepa22 rate information or a copy thereof reported 

23 to a patient safety organization shall not by 

24 reason of its reporting be considered patient 

25 safety work product. 
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1 ‘‘(iii) Nothing in this part shall be 

2 construed to limit— 

3 ‘‘(I) the discovery of or admissi4 bility of information described in this 

5 subparagraph in a criminal, civil, or 

6 administrative proceeding; 

7 ‘‘(II) the reporting of information 

8 described in this subparagraph to a 

9 Federal, State, or local governmental 

10 agency for public health surveillance, 

11 investigation, or other public health 

12 purposes or health oversight purposes; 

13 or 

14 ‘‘(III) a provider’s recordkeeping 

15 obligation with respect to information 

16 described in this subparagraph under 

17 Federal, State, or local law. 

18 ‘‘(8) PROVIDER.—The term ‘provider’ means— 

19 ‘‘(A) an individual or entity licensed or 

20 otherwise authorized under State law to provide 

21 health care services, including— 

22 ‘‘(i) a hospital, nursing facility, com23 prehensive outpatient rehabilitation facility, 

24 home health agency, hospice program, renal 

25 dialysis facility, ambulatory surgical center, 
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1 pharmacy, physician or health care practi2 tioner’s office, long term care facility, be3 havior health residential treatment facility, 

4 clinical laboratory, or health center; or 

5 ‘‘(ii) a physician, physician assistant, 

6 nurse practitioner, clinical nurse specialist, 

7 certified registered nurse anesthetist, cer8 tified nurse midwife, psychologist, certified 

9 social worker, registered dietitian or nutri10 tion professional, physical or occupational 

11 therapist, pharmacist, or other individual 

12 health care practitioner; or 

13 ‘‘(B) any other individual or entity speci14 fied in regulations promulgated by the Secretary. 

15 ‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTEC16 TIONS. 

17 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi18 sion of Federal, State, or local law, and subject to subsection 

19 (c), patient safety work product shall be privileged and shall 

20 not be— 

21 ‘‘(1) subject to a Federal, State, or local civil, 

22 criminal, or administrative subpoena or order, in23 cluding in a Federal, State, or local civil or adminis24 trative disciplinary proceeding against a provider; 
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1 ‘‘(2) subject to discovery in connection with a 

2 Federal, State, or local civil, criminal, or administra3 tive proceeding, including in a Federal, State, or 

4 local civil or administrative disciplinary proceeding 

5 against a provider; 

6 ‘‘(3) subject to disclosure pursuant to section 552 

7 of title 5, United States Code (commonly known as 

8 the Freedom of Information Act) or any other similar 

9 Federal, State, or local law; 

10 ‘‘(4) admitted as evidence in any Federal, State, 

11 or local governmental civil proceeding, criminal pro12 ceeding, administrative rulemaking proceeding, or ad13 ministrative adjudicatory proceeding, including any 

14 such proceeding against a provider; or 

15 ‘‘(5) admitted in a professional disciplinary pro16 ceeding of a professional disciplinary body established 

17 or specifically authorized under State law. 

18 ‘‘(b) CONFIDENTIALITY OF PATIENT SAFETY WORK

19 PRODUCT.—Notwithstanding any other provision of Fed20 eral, State, or local law, and subject to subsection (c), pa21 tient safety work product shall be confidential and shall not 

22 be disclosed. 

23 ‘‘(c) EXCEPTIONS.—Except as provided in subsection 

24 (g)(3)— 
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1 ‘‘(1) EXCEPTIONS FROM PRIVILEGE AND CON2 FIDENTIALITY.—Subsections (a) and (b) shall not 

3 apply to (and shall not be construed to prohibit) one 

4 or more of the following disclosures: 

5 ‘‘(A) Disclosure of relevant patient safety 

6 work product for use in a criminal proceeding, 

7 but only after a court makes an in camera deter8 mination that such patient safety work product 

9 contains evidence of a criminal act and that 

10 such patient safety work product is material to 

11 the proceeding and not reasonably available from 

12 any other source. 

13 ‘‘(B) Disclosure of patient safety work prod14 uct to the extent required to carry out subsection 

15 (f)(4)(A). 

16 ‘‘(C) Disclosure of identifiable patient safety 

17 work product if authorized by each provider 

18 identified in such work product. 

19 ‘‘(2) EXCEPTIONS FROM CONFIDENTIALITY.— 

20 Subsection (b) shall not apply to (and shall not be 

21 construed to prohibit) one or more of the following 

22 disclosures: 

23 ‘‘(A) Disclosure of patient safety work prod24 uct to carry out patient safety activities. 
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1 ‘‘(B) Disclosure of nonidentifiable patient 

2 safety work product. 

3 ‘‘(C) Disclosure of patient safety work prod4 uct to grantees, contractors, or other entities car5 rying out research, evaluation, or demonstration 

6 projects authorized, funded, certified, or other7 wise sanctioned by rule or other means by the 

8 Secretary, for the purpose of conducting research 

9 to the extent that disclosure of protected health 

10 information would be allowed for such purpose 

11 under the HIPAA confidentiality regulations. 

12 ‘‘(D) Disclosure by a provider to the Food 

13 and Drug Administration with respect to a 

14 product or activity regulated by the Food and 

15 Drug Administration. 

16 ‘‘(E) Voluntary disclosure of patient safety 

17 work product by a provider to an accrediting 

18 body that accredits that provider. 

19 ‘‘(F) Disclosures that the Secretary may de20 termine, by rule or other means, are necessary 

21 for business operations and are consistent with 

22 the goals of this part. 

23 ‘‘(G) Disclosure of patient safety work prod24 uct to law enforcement authorities relating to the 

25 commission of a crime (or to an event reasonably 
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1 believed to be a crime) if the person making the 

2 disclosure believes, reasonably under the cir3 cumstances, that the patient safety work product 

4 that is disclosed is necessary for criminal law 

5 enforcement purposes. 

6 ‘‘(H) With respect to a person other than a 

7 patient safety organization, the disclosure of pa8 tient safety work product that does not include 

9 materials that— 

10 ‘‘(i) assess the quality of care of an 

11 identifiable provider; or 

12 ‘‘(ii) describe or pertain to one or more 

13 actions or failures to act by an identifiable 

14 provider. 

15 ‘‘(3) EXCEPTION FROM PRIVILEGE.—Subsection 

16 (a) shall not apply to (and shall not be construed to 

17 prohibit) voluntary disclosure of nonidentifiable pa18 tient safety work product. 

19 ‘‘(d) CONTINUED PROTECTION OF INFORMATION

20 AFTER DISCLOSURE.— 

21 ‘‘(1) IN GENERAL.—Patient safety work product 

22 that is disclosed under subsection (c) shall continue to 

23 be privileged and confidential as provided for in sub24 sections (a) and (b), and such disclosure shall not be 

25 treated as a waiver of privilege or confidentiality, 
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1 and the privileged and confidential nature of such 

2 work product shall also apply to such work product 

3 in the possession or control of a person to whom such 

4 work product was disclosed. 

5 ‘‘(2) EXCEPTION.—Notwithstanding paragraph 

6 (1), and subject to paragraph (3)— 

7 ‘‘(A) if patient safety work product is dis8 closed in a criminal proceeding, the confiden9 tiality protections provided for in subsection (b) 

10 shall no longer apply to the work product so dis11 closed; and 

12 ‘‘(B) if patient safety work product is dis13 closed as provided for in subsection (c)(2)(B) (re14 lating to disclosure of nonidentifiable patient 

15 safety work product), the privilege and confiden16 tiality protections provided for in subsections (a) 

17 and (b) shall no longer apply to such work prod18 uct. 

19 ‘‘(3) CONSTRUCTION.—Paragraph (2) shall not 

20 be construed as terminating or limiting the privilege 

21 or confidentiality protections provided for in sub22 section (a) or (b) with respect to patient safety work 

23 product other than the specific patient safety work 

24 product disclosed as provided for in subsection (c). 

25 ‘‘(4) LIMITATIONS ON ACTIONS.— 
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1 ‘‘(A) PATIENT SAFETY ORGANIZATIONS.— 

2 ‘‘(i) IN GENERAL.—A patient safety or3 ganization shall not be compelled to disclose 

4 information collected or developed under 

5 this part whether or not such information is 

6 patient safety work product unless such in7 formation is identified, is not patient safety 

8 work product, and is not reasonably avail9 able from another source. 

10 ‘‘(ii) NONAPPLICATION.—The limita11 tion contained in clause (i) shall not apply 

12 in an action against a patient safety orga13 nization or with respect to disclosures pur14 suant to subsection (c)(1). 

15 ‘‘(B) PROVIDERS.—An accrediting body 

16 shall not take an accrediting action against a 

17 provider based on the good faith participation of 

18 the provider in the collection, development, re19 porting, or maintenance of patient safety work 

20 product in accordance with this part. An accred21 iting body may not require a provider to reveal 

22 its communications with any patient safety or23 ganization established in accordance with this 

24 part. 

25 ‘‘(e) REPORTER PROTECTION.— 
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1 ‘‘(1) IN GENERAL.—A provider may not take an 

2 adverse employment action, as described in para3 graph (2), against an individual based upon the fact 

4 that the individual in good faith reported informa5 tion— 

6 ‘‘(A) to the provider with the intention of 

7 having the information reported to a patient 

8 safety organization; or 

9 ‘‘(B) directly to a patient safety organiza10 tion. 

11 ‘‘(2) ADVERSE EMPLOYMENT ACTION.—For pur12 poses of this subsection, an ‘adverse employment ac13 tion’ includes— 

14 ‘‘(A) loss of employment, the failure to pro15 mote an individual, or the failure to provide any 

16 other employment-related benefit for which the 

17 individual would otherwise be eligible; or 

18 ‘‘(B) an adverse evaluation or decision 

19 made in relation to accreditation, certification, 

20 credentialing, or licensing of the individual. 

21 ‘‘(f) ENFORCEMENT.— 

22 ‘‘(1) CIVIL MONETARY PENALTY.—Subject to 

23 paragraphs (2) and (3), a person who discloses iden24 tifiable patient safety work product in knowing or 

25 reckless violation of subsection (b) shall be subject to 
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1 a civil monetary penalty of not more than $10,000 

2 for each act constituting such violation. 

3 ‘‘(2) PROCEDURE.—The provisions of section 

4 1128A of the Social Security Act, other than sub5 sections (a) and (b) and the first sentence of sub6 section (c)(1), shall apply to civil money penalties 

7 under this subsection in the same manner as such 

8 provisions apply to a penalty or proceeding under 

9 section 1128A of the Social Security Act. 

10 ‘‘(3) RELATION TO HIPAA.—Penalties shall not 

11 be imposed both under this subsection and under the 

12 regulations issued pursuant to section 264(c)(1) of the 

13 Health Insurance Portability and Accountability Act 

14 of 1996 (42 U.S.C. 1320d–2 note) for a single act or 

15 omission. 

16 ‘‘(4) EQUITABLE RELIEF.— 

17 ‘‘(A) IN GENERAL.—Without limiting rem18 edies available to other parties, a civil action 

19 may be brought by any aggrieved individual to 

20 enjoin any act or practice that violates sub21 section (e) and to obtain other appropriate equi22 table relief (including reinstatement, back pay, 

23 and restoration of benefits) to redress such viola24 tion. 
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1 ‘‘(B) AGAINST STATE EMPLOYEES.—An en2 tity that is a State or an agency of a State gov3 ernment may not assert the privilege described 

4 in subsection (a) unless before the time of the as5 sertion, the entity or, in the case of and with re6 spect to an agency, the State has consented to be 

7 subject to an action described in subparagraph 

8 (A), and that consent has remained in effect. 

9 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec10 tion shall be construed— 

11 ‘‘(1) to limit the application of other Federal, 

12 State, or local laws that provide greater privilege or 

13 confidentiality protections than the privilege and con14 fidentiality protections provided for in this section; 

15 ‘‘(2) to limit, alter, or affect the requirements of 

16 Federal, State, or local law pertaining to information 

17 that is not privileged or confidential under this sec18 tion; 

19 ‘‘(3) except as provided in subsection (i), to alter 

20 or affect the implementation of any provision of the 

21 HIPAA confidentiality regulations or section 1176 of 

22 the Social Security Act (or regulations promulgated 

23 under such section); 

24 ‘‘(4) to limit the authority of any provider, pa25 tient safety organization, or other entity to enter into 
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1 a contract requiring greater confidentiality or dele2 gating authority to make a disclosure or use in ac3 cordance with this section; 

4 ‘‘(5) as preempting or otherwise affecting any 

5 State law requiring a provider to report information 

6 that is not patient safety work product; or 

7 ‘‘(6) to limit, alter, or affect any requirement for 

8 reporting to the Food and Drug Administration in9 formation regarding the safety of a product or activ10 ity regulated by the Food and Drug Administration. 

11 ‘‘(h) CLARIFICATION.—Nothing in this part prohibits 

12 any person from conducting additional analysis for any 

13 purpose regardless of whether such additional analysis in14 volves issues identical to or similar to those for which infor15 mation was reported to or assessed by a patient safety orga16 nization or a patient safety evaluation system. 

17 ‘‘(i) CLARIFICATION OF APPLICATION OF HIPAA CON18 FIDENTIALITY REGULATIONS TO PATIENT SAFETY ORGANI19 ZATIONS.—For purposes of applying the HIPAA confiden20 tiality regulations— 

21 ‘‘(1) patient safety organizations shall be treated 

22 as business associates; and 

23 ‘‘(2) patient safety activities of such organiza24 tions in relation to a provider are deemed to be health 
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1 care operations (as defined in such regulations) of the 

2 provider. 

3 ‘‘(j) REPORTS ON STRATEGIES TO IMPROVE PATIENT

4 SAFETY.— 

5 ‘‘(1) DRAFT REPORT.—Not later than the date 

6 that is 18 months after any network of patient safety 

7 databases is operational, the Secretary, in consulta8 tion with the Director, shall prepare a draft report on 

9 effective strategies for reducing medical errors and in10 creasing patient safety. The draft report shall include 

11 any measure determined appropriate by the Secretary 

12 to encourage the appropriate use of such strategies, 

13 including use in any federally funded programs. The 

14 Secretary shall make the draft report available for 

15 public comment and submit the draft report to the In16 stitute of Medicine for review. 

17 ‘‘(2) FINAL REPORT.—Not later than 1 year 

18 after the date described in paragraph (1), the Sec19 retary shall submit a final report to the Congress. 

20 ‘‘SEC. 923. NETWORK OF PATIENT SAFETY DATABASES. 

21 ‘‘(a) IN GENERAL.—The Secretary shall facilitate the 

22 creation of, and maintain, a network of patient safety data23 bases that provides an interactive evidence-based manage24 ment resource for providers, patient safety organizations, 

25 and other entities. The network of databases shall have the 
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1 capacity to accept, aggregate across the network, and ana2 lyze nonidentifiable patient safety work product voluntarily 

3 reported by patient safety organizations, providers, or other 

4 entities. The Secretary shall assess the feasibility of pro5 viding for a single point of access to the network for quali6 fied researchers for information aggregated across the net7 work and, if feasible, provide for implementation. 

8 ‘‘(b) DATA STANDARDS.—The Secretary may deter9 mine common formats for the reporting to and among the 

10 network of patient safety databases maintained under sub11 section (a) of nonidentifiable patient safety work product, 

12 including necessary work product elements, common and 

13 consistent definitions, and a standardized computer inter14 face for the processing of such work product. To the extent 

15 practicable, such standards shall be consistent with the ad16 ministrative simplification provisions of part C of title XI 

17 of the Social Security Act. 

18 ‘‘(c) USE OF INFORMATION.—Information reported to 

19 and among the network of patient safety databases under 

20 subsection (a) shall be used to analyze national and re21 gional statistics, including trends and patterns of health 

22 care errors. The information resulting from such analyses 

23 shall be made available to the public and included in the 

24 annual quality reports prepared under section 913(b)(2). 
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1 ‘‘SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFI2 CATION AND LISTING. 

3 ‘‘(a) CERTIFICATION.— 

4 ‘‘(1) INITIAL CERTIFICATION.—An entity that 

5 seeks to be a patient safety organization shall submit 

6 an initial certification to the Secretary that the enti7 ty— 

8 ‘‘(A) has policies and procedures in place to 

9 perform each of the patient safety activities de10 scribed in section 921(5); and 

11 ‘‘(B) upon being listed under subsection (d), 

12 will comply with the criteria described in sub13 section (b). 

14 ‘‘(2) SUBSEQUENT CERTIFICATIONS.—An entity 

15 that is a patient safety organization shall submit 

16 every 3 years after the date of its initial listing under 

17 subsection (d) a subsequent certification to the Sec18 retary that the entity— 

19 ‘‘(A) is performing each of the patient safe20 ty activities described in section 921(5); and 

21 ‘‘(B) is complying with the criteria de22 scribed in subsection (b). 

23 ‘‘(b) CRITERIA.— 

24 ‘‘(1) IN GENERAL.—The following are criteria for 

25 the initial and subsequent certification of an entity as 

26 a patient safety organization: 
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1 ‘‘(A) The mission and primary activity of 

2 the entity are to conduct activities that are to 

3 improve patient safety and the quality of health 

4 care delivery. 

5 ‘‘(B) The entity has appropriately qualified 

6 staff (whether directly or through contract), in7 cluding licensed or certified medical profes8 sionals. 

9 ‘‘(C) The entity, within each 24-month pe10 riod that begins after the date of the initial list11 ing under subsection (d), has bona fide contracts, 

12 each of a reasonable period of time, with more 

13 than 1 provider for the purpose of receiving and 

14 reviewing patient safety work product. 

15 ‘‘(D) The entity is not, and is not a compo16 nent of, a health insurance issuer (as defined in 

17 section 2791(b)(2)). 

18 ‘‘(E) The entity shall fully disclose— 

19 ‘‘(i) any financial, reporting, or con20 tractual relationship between the entity and 

21 any provider that contracts with the entity; 

22 and 

23 ‘‘(ii) if applicable, the fact that the en24 tity is not managed, controlled, and oper-
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1 ated independently from any provider that 

2 contracts with the entity. 

3 ‘‘(F) To the extent practical and appro4 priate, the entity collects patient safety work 

5 product from providers in a standardized man6 ner that permits valid comparisons of similar 

7 cases among similar providers. 

8 ‘‘(G) The utilization of patient safety work 

9 product for the purpose of providing direct feed10 back and assistance to providers to effectively 

11 minimize patient risk. 

12 ‘‘(2) ADDITIONAL CRITERIA FOR COMPONENT OR13 GANIZATIONS.—If an entity that seeks to be a patient 

14 safety organization is a component of another organi15 zation, the following are additional criteria for the 

16 initial and subsequent certification of the entity as a 

17 patient safety organization: 

18 ‘‘(A) The entity maintains patient safety 

19 work product separately from the rest of the or20 ganization, and establishes appropriate security 

21 measures to maintain the confidentiality of the 

22 patient safety work product. 

23 ‘‘(B) The entity does not make an unau24 thorized disclosure under this part of patient 
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1 safety work product to the rest of the organiza2 tion in breach of confidentiality. 

3 ‘‘(C) The mission of the entity does not cre4 ate a conflict of interest with the rest of the orga5 nization. 

6 ‘‘(c) REVIEW OF CERTIFICATION.— 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) INITIAL CERTIFICATION.—Upon the 

9 submission by an entity of an initial certifi10 cation under subsection (a)(1), the Secretary 

11 shall determine if the certification meets the re12 quirements of subparagraphs (A) and (B) of such 

13 subsection. 

14 ‘‘(B) SUBSEQUENT CERTIFICATION.—Upon 

15 the submission by an entity of a subsequent cer16 tification under subsection (a)(2), the Secretary 

17 shall review the certification with respect to re18 quirements of subparagraphs (A) and (B) of such 

19 subsection. 

20 ‘‘(2) NOTICE OF ACCEPTANCE OR NON-ACCEPT21 ANCE.—If the Secretary determines that— 

22 ‘‘(A) an entity’s initial certification meets 

23 requirements referred to in paragraph (1)(A), the 

24 Secretary shall notify the entity of the accept25 ance of such certification; or 
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1 ‘‘(B) an entity’s initial certification does 

2 not meet such requirements, the Secretary shall 

3 notify the entity that such certification is not ac4 cepted and the reasons therefor. 

5 ‘‘(3) DISCLOSURES REGARDING RELATIONSHIP

6 TO PROVIDERS.—The Secretary shall consider any 

7 disclosures under subsection (b)(1)(E) by an entity 

8 and shall make public findings on whether the entity 

9 can fairly and accurately perform the patient safety 

10 activities of a patient safety organization. The Sec11 retary shall take those findings into consideration in 

12 determining whether to accept the entity’s initial cer13 tification and any subsequent certification submitted 

14 under subsection (a) and, based on those findings, 

15 may deny, condition, or revoke acceptance of the enti16 ty’s certification. 

17 ‘‘(d) LISTING.—The Secretary shall compile and 

18 maintain a listing of entities with respect to which there 

19 is an acceptance of a certification pursuant to subsection 

20 (c)(2)(A) that has not been revoked under subsection (e) or 

21 voluntarily relinquished. 

22 ‘‘(e) REVOCATION OF ACCEPTANCE OF CERTIFI23 CATION.— 

24 ‘‘(1) IN GENERAL.—If, after notice of deficiency, 

25 an opportunity for a hearing, and a reasonable op-
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1 portunity for correction, the Secretary determines 

2 that a patient safety organization does not meet the 

3 certification requirements under subsection (a)(2), in4 cluding subparagraphs (A) and (B) of such sub5 section, the Secretary shall revoke the Secretary’s ac6 ceptance of the certification of such organization. 

7 ‘‘(2) SUPPLYING CONFIRMATION OF NOTIFICA8 TION TO PROVIDERS.—Within 15 days of a revocation 

9 under paragraph (1), a patient safety organization 

10 shall submit to the Secretary a confirmation that the 

11 organization has taken all reasonable actions to no12 tify each provider whose patient safety work product 

13 is collected or analyzed by the organization of such 

14 revocation. 

15 ‘‘(3) PUBLICATION OF DECISION.—If the Sec16 retary revokes the certification of an organization 

17 under paragraph (1), the Secretary shall— 

18 ‘‘(A) remove the organization from the list19 ing maintained under subsection (d); and 

20 ‘‘(B) publish notice of the revocation in the 

21 Federal Register. 

22 ‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST23 ING.— 

24 ‘‘(1) NEW DATA.—With respect to the privilege 

25 and confidentiality protections described in section 
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1 922, data submitted to an entity within 30 days after 

2 the entity is removed from the listing under sub3 section (e)(3)(A) shall have the same status as data 

4 submitted while the entity was still listed. 

5 ‘‘(2) PROTECTION TO CONTINUE TO APPLY.—If 

6 the privilege and confidentiality protections described 

7 in section 922 applied to patient safety work product 

8 while an entity was listed, or to data described in 

9 paragraph (1), such protections shall continue to 

10 apply to such work product or data after the entity 

11 is removed from the listing under subsection (e)(3)(A). 

12 ‘‘(g) DISPOSITION OF WORK PRODUCT AND DATA.— 

13 If the Secretary removes a patient safety organization from 

14 the listing as provided for in subsection (e)(3)(A), with re15 spect to the patient safety work product or data described 

16 in subsection (f)(1) that the patient safety organization re17 ceived from another entity, such former patient safety orga18 nization shall— 

19 ‘‘(1) with the approval of the other entity and a 

20 patient safety organization, transfer such work prod21 uct or data to such patient safety organization; 

22 ‘‘(2) return such work product or data to the en23 tity that submitted the work product or data; or 
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1 ‘‘(3) if returning such work product or data to 

2 such entity is not practicable, destroy such work 

3 product or data. 

4 ‘‘SEC. 925. TECHNICAL ASSISTANCE. 

5 ‘‘The Secretary, acting through the Director, may pro6 vide technical assistance to patient safety organizations, in7 cluding convening annual meetings for patient safety orga8 nizations to discuss methodology, communication, data col9 lection, or privacy concerns. 

10 ‘‘SEC. 926. SEVERABILITY. 

11 ‘‘If any provision of this part is held to be unconstitu12 tional, the remainder of this part shall not be affected.’’. 

13 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

14 937 of the Public Health Service Act (as redesignated by 

15 subsection (a)) is amended by adding at the end the fol16 lowing: 

17 ‘‘(e) PATIENT SAFETY AND QUALITY IMPROVEMENT.— 

18 For the purpose of carrying out part C, there are authorized 

19 to be appropriated such sums as may be necessary for each 

20 of the fiscal years 2006 through 2010.’’. 

21 (c) GAO STUDY ON IMPLEMENTATION.— 

22 (1) STUDY.—The Comptroller General of the 

23 United States shall conduct a study on the effective24 ness of part C of title IX of the Public Health Service 
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1 Act (as added by subsection (a)) in accomplishing the 

2 purposes of such part. 

3 (2) REPORT.—Not later than February 1, 2010, 

4 the Comptroller General shall submit a report on the 

5 study conducted under paragraph (1). Such report 

6 shall include such recommendations for changes in 

7 such part as the Comptroller General deems appro8 priate. 
Union Calendar No. 117 

109TH CONGRESS 

1ST SESSION H. R. 3205 

[Report No. 109–197] 

A BILL 

To amend title IX of the Public Health Service Act 

poses. versely affect patient safety, and for other purand to reduce the incidence of events that adto provide for the improvement of patient safety 

JULY 27, 2005 

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