109TH CONGRESS

1ST SESSION S. 544

AN ACT

To amend title IX of the Public Health Service Act to

provide for the improvement of patient safety and to

reduce the incidence of events that adversely effect patient safety.

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

5 ‘‘Patient Safety and Quality Improvement Act of 2005’’.
 †

2

S 544 ES

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

2 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.

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

4 (a) IN GENERAL.—Title IX of the Public Health

5 Service Act (42 U.S.C. 299 et seq.) is amended—

6 (1) in section 912(c), by inserting ‘‘, in accord7 ance with part C,’’ after ‘‘The Director shall’’;

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

9 (3) by redesignating sections 921 through 928,

10 as sections 931 through 938, respectively;

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

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

13 (5) by inserting after part B the following:

14 ‘‘PART C—PATIENT SAFETY IMPROVEMENT

15 ‘‘SEC. 921. DEFINITIONS.

16 ‘‘In this part:

17 ‘‘(1) HIPAA CONFIDENTIALITY REGULA18 TIONS.—The term ‘HIPAA confidentiality regula19 tions’ means regulations promulgated under section

20 264(c) of the Health Insurance Portability and Ac-
†

3

S 544 ES

1 countability Act of 1996 (Public Law 104–191; 110

2 Stat. 2033).

3 ‘‘(2) IDENTIFIABLE PATIENT SAFETY WORK

4 PRODUCT.—The term ‘identifiable patient safety

5 work product’ means patient safety work product

6 that—

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

8 that allows the identification of any provider

9 that is a subject of the work product, or any

10 providers that participate in activities that are

11 a subject of the work product;

12 ‘‘(B) constitutes individually identifiable

13 health information as that term is defined in

14 the HIPAA confidentiality regulations; or

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

16 that allows the identification of an individual

17 who reported information in the manner speci18 fied in section 922(e).

19 ‘‘(3) NONIDENTIFIABLE PATIENT SAFETY WORK

20 PRODUCT.—The term ‘nonidentifiable patient safety

21 work product’ means patient safety work product

22 that is not identifiable patient safety work product

23 (as defined in paragraph (2)).

24 ‘‘(4) PATIENT SAFETY ORGANIZATION.—The

25 term ‘patient safety organization’ means a private or
†

4

S 544 ES

1 public entity or component thereof that is listed by

2 the Secretary pursuant to section 924(d).

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

4 ‘patient safety activities’ means the following activi5 ties:

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

7 the quality of health care delivery.

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

9 safety work product.

10 ‘‘(C) The development and dissemination

11 of information with respect to improving patient

12 safety, such as recommendations, protocols, or

13 information regarding best practices.

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

15 product for the purposes of encouraging a cul16 ture of safety and of providing feedback and as17 sistance to effectively minimize patient risk.

18 ‘‘(E) The maintenance of procedures to

19 preserve confidentiality with respect to patient

20 safety work product.

21 ‘‘(F) The provision of appropriate security

22 measures with respect to patient safety work

23 product.

24 ‘‘(G) The utilization of qualified staff.
†

5

S 544 ES

1 ‘‘(H) Activities related to the operation of

2 a patient safety evaluation system and to the

3 provision of feedback to participants in a pa4 tient safety evaluation system.

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

6 The term ‘patient safety evaluation system’ means

7 the collection, management, or analysis of informa8 tion for reporting to or by a patient safety organiza9 tion.

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

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

12 subparagraph (B), the term ‘patient safety

13 work product’ means any data, reports, records,

14 memoranda, analyses (such as root cause anal15 yses), or written or oral statements—

16 ‘‘(i) which—

17 ‘‘(I) are assembled or developed

18 by a provider for reporting to a pa19 tient safety organization and are re20 ported to a patient safety organiza21 tion; or

22 ‘‘(II) are developed by a patient

23 safety organization for the conduct of

24 patient safety activities;
†

6

S 544 ES

1 and which could result in improved patient

2 safety, health care quality, or health care

3 outcomes; or

4 ‘‘(ii) which identify or constitute the

5 deliberations or analysis of, or identify the

6 fact of reporting pursuant to, a patient

7 safety evaluation system.

8 ‘‘(B) CLARIFICATION.—

9 ‘‘(i) Information described in subpara10 graph (A) does not include a patient’s

11 medical record, billing and discharge infor12 mation, or any other original patient or

13 provider record.

14 ‘‘(ii) Information described in sub15 paragraph (A) does not include informa16 tion that is collected, maintained, or devel17 oped separately, or exists separately, from

18 a patient safety evaluation system. Such

19 separate information or a copy thereof re20 ported to a patient safety organization

21 shall not by reason of its reporting be con22 sidered patient safety work product.

23 ‘‘(iii) Nothing in this part shall be

24 construed to limit—
†

7

S 544 ES

1 ‘‘(I) the discovery of or admissi2 bility of information described in this

3 subparagraph in a criminal, civil, or

4 administrative proceeding;

5 ‘‘(II) the reporting of information

6 described in this subparagraph to a

7 Federal, State, or local governmental

8 agency for public health surveillance,

9 investigation, or other public health

10 purposes or health oversight purposes;

11 or

12 ‘‘(III) a provider’s recordkeeping

13 obligation with respect to information

14 described in this subparagraph under

15 Federal, State, or local law.

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

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

18 otherwise authorized under State law to provide

19 health care services, including—

20 ‘‘(i) a hospital, nursing facility, com21 prehensive outpatient rehabilitation facil22 ity, home health agency, hospice program,

23 renal dialysis facility, ambulatory surgical

24 center, pharmacy, physician or health care

25 practitioner’s office, long term care facility,
†

8

S 544 ES

1 behavior health residential treatment facil2 ity, clinical laboratory, or health center; or

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

4 nurse practitioner, clinical nurse specialist,

5 certified registered nurse anesthetist, cer6 tified nurse midwife, psychologist, certified

7 social worker, registered dietitian or nutri8 tion professional, physical or occupational

9 therapist, pharmacist, or other individual

10 health care practitioner; or

11 ‘‘(B) any other individual or entity speci12 fied in regulations promulgated by the Sec13 retary.

14 ‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTEC15 TIONS.

16 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi17 sion of Federal, State, or local law, and subject to sub18 section (c), patient safety work product shall be privileged

19 and shall not be—

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

21 criminal, or administrative subpoena or order, in22 cluding in a Federal, State, or local civil or adminis23 trative disciplinary proceeding against a provider;

24 ‘‘(2) subject to discovery in connection with a

25 Federal, State, or local civil, criminal, or administra-
†

9

S 544 ES

1 tive proceeding, including in a Federal, State, or

2 local civil or administrative disciplinary proceeding

3 against a provider;

4 ‘‘(3) subject to disclosure pursuant to section

5 552 of title 5, United States Code (commonly known

6 as the Freedom of Information Act) or any other

7 similar Federal, State, or local law;

8 ‘‘(4) admitted as evidence in any Federal,

9 State, or local governmental civil proceeding, crimi10 nal proceeding, administrative rulemaking pro11 ceeding, or administrative adjudicatory proceeding,

12 including any such proceeding against a provider; or

13 ‘‘(5) admitted in a professional disciplinary pro14 ceeding of a professional disciplinary body estab15 lished or specifically authorized under State law.

16 ‘‘(b) CONFIDENTIALITY OF PATIENT SAFETY WORK

17 PRODUCT.—Notwithstanding any other provision of Fed18 eral, State, or local law, and subject to subsection (c), pa19 tient safety work product shall be confidential and shall

20 not be disclosed.

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

22 (g)(3)—

23 ‘‘(1) EXCEPTIONS FROM PRIVILEGE AND CON24 FIDENTIALITY.—Subsections (a) and (b) shall not
†

10

S 544 ES

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

2 or more of the following disclosures:

3 ‘‘(A) Disclosure of relevant patient safety

4 work product for use in a criminal proceeding,

5 but only after a court makes an in camera de6 termination that such patient safety work prod7 uct contains evidence of a criminal act and that

8 such patient safety work product is material to

9 the proceeding and not reasonably available

10 from any other source.

11 ‘‘(B) Disclosure of patient safety work

12 product to the extent required to carry out sub13 section (f)(4)(A).

14 ‘‘(C) Disclosure of identifiable patient safe15 ty work product if authorized by each provider

16 identified in such work product.

17 ‘‘(2) EXCEPTIONS FROM CONFIDENTIALITY.—

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

19 construed to prohibit) one or more of the following

20 disclosures:

21 ‘‘(A) Disclosure of patient safety work

22 product to carry out patient safety activities.

23 ‘‘(B) Disclosure of nonidentifiable patient

24 safety work product.
†

11

S 544 ES

1 ‘‘(C) Disclosure of patient safety work

2 product to grantees, contractors, or other enti3 ties carrying out research, evaluation, or dem4 onstration projects authorized, funded, certified,

5 or otherwise sanctioned by rule or other means

6 by the Secretary, for the purpose of conducting

7 research to the extent that disclosure of pro8 tected health information would be allowed for

9 such purpose under the HIPAA confidentiality

10 regulations.

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

12 and Drug Administration with respect to a

13 product or activity regulated by the Food and

14 Drug Administration.

15 ‘‘(E) Voluntary disclosure of patient safety

16 work product by a provider to an accrediting

17 body that accredits that provider.

18 ‘‘(F) Disclosures that the Secretary may

19 determine, by rule or other means, are nec20 essary for business operations and are con21 sistent with the goals of this part.

22 ‘‘(G) Disclosure of patient safety work

23 product to law enforcement authorities relating

24 to the commission of a crime (or to an event

25 reasonably believed to be a crime) if the person
†

12

S 544 ES

1 making the disclosure believes, reasonably

2 under the circumstances, that the patient safety

3 work product that is disclosed is necessary for

4 criminal law enforcement purposes.

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

6 a patient safety organization, the disclosure of

7 patient safety work product that does not in8 clude materials that—

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

10 identifiable provider; or

11 ‘‘(ii) describe or pertain to one or

12 more actions or failures to act by an iden13 tifiable provider.

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

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

16 prohibit) voluntary disclosure of nonidentifiable pa17 tient safety work product.

18 ‘‘(d) CONTINUED PROTECTION OF INFORMATION

19 AFTER DISCLOSURE.—

20 ‘‘(1) IN GENERAL.—Patient safety work prod21 uct that is disclosed under subsection (c) shall con22 tinue to be privileged and confidential as provided

23 for in subsections (a) and (b), and such disclosure

24 shall not be treated as a waiver of privilege or con25 fidentiality, and the privileged and confidential na-
†

13

S 544 ES

1 ture of such work product shall also apply to such

2 work product in the possession or control of a per3 son to whom such work product was disclosed.

4 ‘‘(2) EXCEPTION.—Notwithstanding paragraph

5 (1), and subject to paragraph (3)—

6 ‘‘(A) if patient safety work product is dis7 closed in a criminal proceeding, the confiden8 tiality protections provided for in subsection (b)

9 shall no longer apply to the work product so

10 disclosed; and

11 ‘‘(B) if patient safety work product is dis12 closed as provided for in subsection (c)(2)(B)

13 (relating to disclosure of nonidentifiable patient

14 safety work product), the privilege and con15 fidentiality protections provided for in sub16 sections (a) and (b) shall no longer apply to

17 such work product.

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

19 be construed as terminating or limiting the privilege

20 or confidentiality protections provided for in sub21 section (a) or (b) with respect to patient safety work

22 product other than the specific patient safety work

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

24 ‘‘(4) LIMITATIONS ON ACTIONS.—

25 ‘‘(A) PATIENT SAFETY ORGANIZATIONS.—
†

14

S 544 ES

1 ‘‘(i) IN GENERAL.—A patient safety

2 organization shall not be compelled to dis3 close information collected or developed

4 under this part whether or not such infor5 mation is patient safety work product un6 less such information is identified, is not

7 patient safety work product, and is not

8 reasonably available from another source.

9 ‘‘(ii) NONAPPLICATION.—The limita10 tion contained in clause (i) shall not apply

11 in an action against a patient safety orga12 nization or with respect to disclosures pur13 suant to subsection (c)(1).

14 ‘‘(B) PROVIDERS.—An accrediting body shall

15 not take an accrediting action against a provider

16 based on the good faith participation of the provider

17 in the collection, development, reporting, or mainte18 nance of patient safety work product in accordance

19 with this part. An accrediting body may not require

20 a provider to reveal its communications with any pa21 tient safety organization established in accordance

22 with this part.

23 ‘‘(e) REPORTER PROTECTION.—

24 ‘‘(1) IN GENERAL.—A provider may not take an

25 adverse employment action, as described in para-
†

15

S 544 ES

1 graph (2), against an individual based upon the fact

2 that the individual in good faith reported

3 information—

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

5 having the information reported to a patient

6 safety organization; or

7 ‘‘(B) directly to a patient safety organiza8 tion.

9 ‘‘(2) ADVERSE EMPLOYMENT ACTION.—For

10 purposes of this subsection, an ‘adverse employment

11 action’ includes—

12 ‘‘(A) loss of employment, the failure to

13 promote an individual, or the failure to provide

14 any other employment-related benefit for which

15 the individual would otherwise be eligible; or

16 ‘‘(B) an adverse evaluation or decision

17 made in relation to accreditation, certification,

18 credentialing, or licensing of the individual.

19 ‘‘(f) ENFORCEMENT.—

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

21 paragraphs (2) and (3), a person who discloses iden22 tifiable patient safety work product in knowing or

23 reckless violation of subsection (b) shall be subject

24 to a civil monetary penalty of not more than

25 $10,000 for each act constituting such violation.
†

16

S 544 ES

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

2 1128A of the Social Security Act, other than sub3 sections (a) and (b) and the first sentence of sub4 section (c)(1), shall apply to civil money penalties

5 under this subsection in the same manner as such

6 provisions apply to a penalty or proceeding under

7 section 1128A of the Social Security Act.

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

9 be imposed both under this subsection and under the

10 regulations issued pursuant to section 264(c)(1) of

11 the Health Insurance Portability and Accountability

12 Act of 1996 (42 U.S.C. 1320d-2 note) for a single

13 act or omission.

14 ‘‘(4) EQUITABLE RELIEF.—

15 ‘‘(A) IN GENERAL.—Without limiting rem16 edies available to other parties, a civil action

17 may be brought by any aggrieved individual to

18 enjoin any act or practice that violates sub19 section (e) and to obtain other appropriate eq20 uitable relief (including reinstatement, back

21 pay, and restoration of benefits) to redress such

22 violation.

23 ‘‘(B) AGAINST STATE EMPLOYEES.—An

24 entity that is a State or an agency of a State

25 government may not assert the privilege de-
†

17

S 544 ES

1 scribed in subsection (a) unless before the time

2 of the assertion, the entity or, in the case of

3 and with respect to an agency, the State has

4 consented to be subject to an action described

5 in subparagraph (A), and that consent has re6 mained in effect.

7 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec8 tion shall be construed—

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

10 State, or local laws that provide greater privilege or

11 confidentiality protections than the privilege and

12 confidentiality protections provided for in this sec13 tion;

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

15 of Federal, State, or local law pertaining to informa16 tion that is not privileged or confidential under this

17 section;

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

19 alter or affect the implementation of any provision

20 of the HIPAA confidentiality regulations or section

21 1176 of the Social Security Act (or regulations pro22 mulgated under such section);

23 ‘‘(4) to limit the authority of any provider, pa24 tient safety organization, or other entity to enter

25 into a contract requiring greater confidentiality or
†

18

S 544 ES

1 delegating authority to make a disclosure or use in

2 accordance with this section;

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

4 State law requiring a provider to report information

5 that is not patient safety work product; or

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

7 for reporting to the Food and Drug Administration

8 information regarding the safety of a product or ac9 tivity regulated by the Food and Drug Administra10 tion.

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 in15 formation was reported to or assessed by a patient safety

16 organization or a patient safety evaluation system.

17 ‘‘(i) CLARIFICATION OF APPLICATION OF HIPAA CON18 FIDENTIALITY REGULATIONS TO PATIENT SAFETY ORGA19 NIZATIONS.—For purposes of applying the HIPAA con20 fidentiality regulations—

21 ‘‘(1) patient safety organizations shall be treat22 ed as business associates; and

23 ‘‘(2) patient safety activities of such organiza24 tions in relation to a provider are deemed to be
†

19

S 544 ES

1 health care operations (as defined in such regula2 tions) of the 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 safe7 ty databases is operational, the Secretary, in con8 sultation with the Director, shall prepare a draft re9 port on effective strategies for reducing medical er10 rors and increasing patient safety. The draft report

11 shall include any measure determined appropriate by

12 the Secretary to encourage the appropriate use of

13 such strategies, including use in any federally fund14 ed programs. The Secretary shall make the draft re15 port available for public comment and submit the

16 draft report to the Institute 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

23 databases that provides an interactive evidence-based

24 management resource for providers, patient safety organi25 zations, and other entities. The network of databases shall
†

20

S 544 ES

1 have the capacity to accept, aggregate across the network,

2 and analyze nonidentifiable patient safety work product

3 voluntarily reported by patient safety organizations, pro4 viders, or other entities. The Secretary shall assess the

5 feasibility of providing for a single point of access to the

6 network for qualified researchers for information aggre7 gated across the network and, if feasible, provide for im8 plementation.

9 ‘‘(b) DATA STANDARDS.—The Secretary may deter10 mine common formats for the reporting to and among the

11 network of patient safety databases maintained under sub12 section (a) of nonidentifiable patient safety work product,

13 including necessary work product elements, common and

14 consistent definitions, and a standardized computer inter15 face for the processing of such work product. To the ex16 tent practicable, such standards shall be consistent with

17 the administrative simplification provisions of part C of

18 title XI of the Social Security Act.

19 ‘‘(c) USE OF INFORMATION.—Information reported

20 to and among the network of patient safety databases

21 under subsection (a) shall be used to analyze national and

22 regional statistics, including trends and patterns of health

23 care errors. The information resulting from such analyses

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

25 annual quality reports prepared under section 913(b)(2).
†

21

S 544 ES

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 sub6 mit an initial certification to the Secretary that the

7 entity—

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

9 to perform each of the patient safety activities

10 described in section 921(5); and

11 ‘‘(B) upon being listed under subsection

12 (d), will comply with the criteria described in

13 subsection (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

17 under subsection (d) a subsequent certification to

18 the Secretary that the entity—

19 ‘‘(A) is performing each of the patient

20 safety 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

25 for the initial and subsequent certification of an en26 tity as a patient safety organization:
†

22

S 544 ES

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 con12 tracts, each of a reasonable period of time, with

13 more than 1 provider for the purpose of receiv14 ing and reviewing patient safety work product.

15 ‘‘(D) The entity is not, and is not a com16 ponent of, a health insurance issuer (as defined

17 in section 2791(b)(2)).

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

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

21 and any provider that contracts with the

22 entity; and

23 ‘‘(ii) if applicable, the fact that the

24 entity is not managed, controlled, and op-
†

23

S 544 ES

1 erated independently from any provider

2 that 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

10 feedback and assistance to providers to effec11 tively minimize patient risk.

12 ‘‘(2) ADDITIONAL CRITERIA FOR COMPONENT

13 ORGANIZATIONS.—If an entity that seeks to be a pa14 tient safety organization is a component of another

15 organization, the following are additional criteria for

16 the initial and subsequent certification of the entity

17 as a 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
†

24

S 544 ES

1 safety work product to the rest of the organiza2 tion in breach of confidentiality.

3 ‘‘(C) The mission of the entity does not

4 create a conflict of interest with the rest of the

5 organization.

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

13 such subsection.

14 ‘‘(B) SUBSEQUENT CERTIFICATION.—

15 Upon the submission by an entity of a subse16 quent certification under subsection (a)(2), the

17 Secretary shall review the certification with re18 spect to requirements of subparagraphs (A) and

19 (B) of such 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),

24 the Secretary shall notify the entity of the ac25 ceptance of such certification; or
†

25

S 544 ES

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

4 accepted 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

13 certification and any subsequent certification sub14 mitted under subsection (a) and, based on those

15 findings, may deny, condition, or revoke acceptance

16 of the entity’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)

21 or voluntarily relinquished.

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

24 ‘‘(1) IN GENERAL.—If, after notice of defi25 ciency, an opportunity for a hearing, and a reason-
†

26

S 544 ES

1 able opportunity for correction, the Secretary deter2 mines that a patient safety organization does not

3 meet the certification requirements under subsection

4 (a)(2), including subparagraphs (A) and (B) of such

5 subsection, the Secretary shall revoke the Sec6 retary’s acceptance of the certification of such orga7 nization.

8 ‘‘(2) SUPPLYING CONFIRMATION OF NOTIFICA9 TION TO PROVIDERS.—Within 15 days of a revoca10 tion under paragraph (1), a patient safety organiza11 tion shall submit to the Secretary a confirmation

12 that the organization has taken all reasonable ac13 tions to notify each provider whose patient safety

14 work product is collected or analyzed by the organi15 zation of such revocation.

16 ‘‘(3) PUBLICATION OF DECISION.—If the Sec17 retary revokes the certification of an organization

18 under paragraph (1), the Secretary shall—

19 ‘‘(A) remove the organization from the list20 ing maintained under subsection (d); and

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

22 Federal Register.

23 ‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST24 ING.—
†

27

S 544 ES

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

2 and confidentiality protections described in section

3 922, data submitted to an entity within 30 days

4 after the entity is removed from the listing under

5 subsection (e)(3)(A) shall have the same status as

6 data submitted while the entity was still listed.

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

8 the privilege and confidentiality protections de9 scribed in section 922 applied to patient safety work

10 product while an entity was listed, or to data de11 scribed in paragraph (1), such protections shall con12 tinue to apply to such work product or data after

13 the entity is removed from the listing under sub14 section (e)(3)(A).

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

16 If the Secretary removes a patient safety organization

17 from the listing as provided for in subsection (e)(3)(A),

18 with respect to the patient safety work product or data

19 described in subsection (f)(1) that the patient safety orga20 nization received from another entity, such former patient

21 safety organization shall—

22 ‘‘(1) with the approval of the other entity and

23 a patient safety organization, transfer such work

24 product or data to such patient safety organization;
†

28

S 544 ES

1 ‘‘(2) return such work product or data to the

2 entity that submitted the work product or data; or

3 ‘‘(3) if returning such work product or data to

4 such entity is not practicable, destroy such work

5 product or data.

6 ‘‘SEC. 925. TECHNICAL ASSISTANCE.

7 ‘‘The Secretary, acting through the Director, may

8 provide technical assistance to patient safety organiza9 tions, including convening annual meetings for patient

10 safety organizations to discuss methodology, communica11 tion, data collection, or privacy concerns.

12 ‘‘SEC. 926. SEVERABILITY.

13 ‘‘If any provision of this part is held to be unconstitu14 tional, the remainder of this part shall not be affected.’’.

15 (b) AUTHORIZATION OF APPROPRIATIONS.—Section

16 937 of the Public Health Service Act (as redesignated by

17 subsection (a)) is amended by adding at the end the fol18 lowing:

19 ‘‘(e) PATIENT SAFETY AND QUALITY IMPROVE20 MENT.—For the purpose of carrying out part C, there are

21 authorized to be appropriated such sums as may be nec22 essary for each of the fiscal years 2006 through 2010.’’.

23 (c) GAO STUDY ON IMPLEMENTATION.—

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

25 United States shall conduct a study on the effective-
†

29

S 544 ES

1 ness of part C of title IX of the Public Health Serv2 ice Act (as added by subsection (a)) in accom3 plishing the purposes of such part.

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

5 2010, the Comptroller General shall submit a report

6 on the study conducted under paragraph (1). Such

7 report shall include such recommendations for

8 changes in such part as the Comptroller General

9 deems appropriate.

Passed the Senate July 21, 2005.

Attest:

Secretary.
109TH CONGRESS

1ST SESSION S. 544

AN ACT

To amend title IX of the Public Health Service Act

versely effect patient safety.and to reduce the incidence of events that adto provide for the improvement of patient safety