PUBLIC LAW 109–41—JULY 29, 2005

PATIENT SAFETY AND QUALITY

IMPROVEMENT ACT OF 2005

119 STAT. 424 PUBLIC LAW 109–41—JULY 29, 2005

Public Law 109–41

109th Congress

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.

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).

42 USC 299b–21.

42 USC 299c–7.

42 USC

299c—299c–7.

42 USC 299b–1.

Patient Safety

and Quality

Improvement Act

of 2005.

July 29, 2005

[S. 544]

PUBLIC LAW 109–41—JULY 29, 2005 119 STAT. 425

‘‘(2) IDENTIFIABLE PATIENT SAFETY WORK PRODUCT.—The

term ‘identifiable patient safety work product’ means patient

safety work product that—

‘‘(A) is presented in a form and manner that allows

the identification of any provider that is a subject of the

work product, or any providers that participate in activities

that are a subject of the work product;

‘‘(B) constitutes individually identifiable health

information as that term is defined in the HIPAA confidentiality regulations; or

‘‘(C) is presented in a form and manner that allows

the identification of an individual who reported information

in the manner specified in section 922(e).

‘‘(3) NONIDENTIFIABLE PATIENT SAFETY WORK PRODUCT.—

The term ‘nonidentifiable patient safety work product’ means

patient safety work product that is not identifiable patient

safety work product (as defined in paragraph (2)).

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

safety organization’ means a private or public entity or component thereof that is listed by the Secretary pursuant to section

924(d).

‘‘(5) PATIENT SAFETY ACTIVITIES.—The term ‘patient safety

activities’ means the following activities:

‘‘(A) Efforts to improve patient safety and the quality

of health care delivery.

‘‘(B) The collection and analysis of patient safety work

product.

‘‘(C) The development and dissemination of information

with respect to improving patient safety, such as recommendations, protocols, or information regarding best

practices.

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

for the purposes of encouraging a culture of safety and

of providing feedback and assistance to effectively minimize

patient risk.

‘‘(E) The maintenance of procedures to preserve confidentiality with respect to patient safety work product.

‘‘(F) The provision of appropriate security measures

with respect to patient safety work product.

‘‘(G) The utilization of qualified staff.

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

safety evaluation system and to the provision of feedback

to participants in a patient safety evaluation system.

‘‘(6) PATIENT SAFETY EVALUATION SYSTEM.—The term

‘patient safety evaluation system’ means the collection, management, or analysis of information for reporting to or by a patient

safety organization.

‘‘(7) PATIENT SAFETY WORK PRODUCT.—

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

(B), the term ‘patient safety work product’ means any data,

reports, records, memoranda, analyses (such as root cause

analyses), or written or oral statements—

‘‘(i) which—

‘‘(I) are assembled or developed by a provider

for reporting to a patient safety organization and

are reported to a patient safety organization; or

119 STAT. 426 PUBLIC LAW 109–41—JULY 29, 2005

‘‘(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.

PUBLIC LAW 109–41—JULY 29, 2005 119 STAT. 427

‘‘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.

42 USC 299b–22.

119 STAT. 428 PUBLIC LAW 109–41—JULY 29, 2005

‘‘(D) Disclosure by a provider to the Food and Drug

Administration with respect to a product or activity regulated by the Food and Drug Administration.

‘‘(E) Voluntary disclosure of patient safety work

product by a provider to an accrediting body that accredits

that provider.

‘‘(F) Disclosures that the Secretary may determine,

by rule or other means, are necessary for business operations and are consistent with the goals of this part.

‘‘(G) Disclosure of patient safety work product to law

enforcement authorities relating to the commission of a

crime (or to an event reasonably believed to be a crime)

if the person making the disclosure believes, reasonably

under the circumstances, that the patient safety work

product that is disclosed is necessary for criminal law

enforcement purposes.

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

safety organization, the disclosure of patient safety work

product that does not include materials that—

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

provider; or

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

or failures to act by an identifiable provider.

‘‘(3) EXCEPTION FROM PRIVILEGE.—Subsection (a) shall not

apply to (and shall not be construed to prohibit) voluntary

disclosure of nonidentifiable patient safety work product.

‘‘(d) CONTINUED PROTECTION OF INFORMATION AFTER DISCLOSURE.—

‘‘(1) IN GENERAL.—Patient safety work product that is disclosed under subsection (c) shall continue to be privileged and

confidential as provided for in subsections (a) and (b), and

such disclosure shall not be treated as a waiver of privilege

or confidentiality, and the privileged and confidential nature

of such work product shall also apply to such work product

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

product was disclosed.

‘‘(2) EXCEPTION.—Notwithstanding paragraph (1), and subject to paragraph (3)—

‘‘(A) if patient safety work product is disclosed in a

criminal proceeding, the confidentiality protections provided for in subsection (b) shall no longer apply to the

work product so disclosed; and

‘‘(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B) (relating to disclosure of

nonidentifiable patient safety work product), the privilege

and confidentiality protections provided for in subsections

(a) and (b) shall no longer apply to such work product.

‘‘(3) CONSTRUCTION.—Paragraph (2) shall not be construed

as terminating or limiting the privilege or confidentiality protections provided for in subsection (a) or (b) with respect to patient

safety work product other than the specific patient safety work

product disclosed as provided for in subsection (c).

‘‘(4) LIMITATIONS ON ACTIONS.—

‘‘(A) PATIENT SAFETY ORGANIZATIONS.—

‘‘(i) IN GENERAL.—A patient safety organization

shall not be compelled to disclose information collected

or developed under this part whether or not such

PUBLIC LAW 109–41—JULY 29, 2005 119 STAT. 429

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 employmentrelated 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.

119 STAT. 430 PUBLIC LAW 109–41—JULY 29, 2005

‘‘(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.

Public

information.

PUBLIC LAW 109–41—JULY 29, 2005 119 STAT. 431

‘‘(2) FINAL REPORT.—Not later than 1 year after the date

described in paragraph (1), the Secretary shall submit a final

report to the Congress.

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

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

of, and maintain, a network of patient safety databases that provides an interactive evidence-based management resource for providers, patient safety organizations, and other entities. The network

of databases shall have the capacity to accept, aggregate across

the network, and analyze nonidentifiable patient safety work

product voluntarily reported by patient safety organizations, providers, or other entities. The Secretary shall assess the feasibility

of providing for a single point of access to the network for qualified

researchers for information aggregated across the network and,

if feasible, provide for implementation.

‘‘(b) DATA STANDARDS.—The Secretary may determine common

formats for the reporting to and among the network of patient

safety databases maintained under subsection (a) of nonidentifiable

patient safety work product, including necessary work product elements, common and consistent definitions, and a standardized computer interface for the processing of such work product. To the

extent practicable, such standards shall be consistent with the

administrative simplification provisions of part C of title XI of

the Social Security Act.

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

the network of patient safety databases under subsection (a) shall

be used to analyze national and regional statistics, including trends

and patterns of health care errors. The information resulting from

such analyses shall be made available to the public and included

in the annual quality reports prepared under section 913(b)(2).

‘‘SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND

LISTING.

‘‘(a) CERTIFICATION.— ‘‘(1) INITIAL CERTIFICATION.—An entity that seeks to be

a patient safety organization shall submit an initial certification

to the Secretary that the entity—

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

each of the patient safety activities described in section

921(5); and

‘‘(B) upon being listed under subsection (d), will comply

with the criteria described in subsection (b).

‘‘(2) SUBSEQUENT CERTIFICATIONS.—An entity that is a

patient safety organization shall submit every 3 years after

the date of its initial listing under subsection (d) a subsequent

certification to the Secretary that the entity—

‘‘(A) is performing each of the patient safety activities

described in section 921(5); and

‘‘(B) is complying with the criteria described in subsection (b).

‘‘(b) CRITERIA.—

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

and subsequent certification of an entity as a patient safety

organization:

‘‘(A) The mission and primary activity of the entity

are to conduct activities that are to improve patient safety

and the quality of health care delivery.

Deadlines.

42 USC 299b–24.

Public

information.

42 USC 299b–23.

119 STAT. 432 PUBLIC LAW 109–41—JULY 29, 2005

‘‘(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

PUBLIC LAW 109–41—JULY 29, 2005 119 STAT. 433

‘‘(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 PRO- VIDERS.—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—

Federal Register,

publication.

Deadline.

119 STAT. 434 PUBLIC LAW 109–41—JULY 29, 2005

LEGISLATIVE HISTORY—S. 544 (H.R. 3205):

HOUSE REPORTS: No. 109–197 accompanying H.R. 3205 (Comm. on Energy and

Commerce).

CONGRESSIONAL RECORD, Vol. 151 (2005):

July 21, considered and passed Senate.

July 27, considered and passed House.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 41 (2005):

July 29, Presidential remarks.

Æ

‘‘(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.

Approved July 29, 2005.

42 USC 299c–6.

42 USC 299b–26.

42 USC 299b–25.