19–006

107TH CONGRESS REPT. 107–714 " HOUSE OF REPRESENTATIVES ! 2d Session Part 1

PATIENT SAFETY IMPROVEMENT ACT OF 2002

OCTOBER 1, 2002.—Ordered to be printed 

Mr. THOMAS, from the Committee on Ways and Means, 

submitted the following 

R E P O R T 

[To accompany H.R. 4889] 

[Including cost estimate of the Congressional Budget Office]

The Committee on Ways and Means, to whom was referred the 

bill (H.R. 4889) to amend title XI of the Social Security Act to improve patient safety, having considered the same, report favorably 

thereon with an amendment and recommend that the bill as 

amended do pass.

CONTENTS 

Page 

I. Introduction ...................................................................................................... 9

A. Purpose and Summary ........................................................................ 9

B. Legislative History .............................................................................. 10

II. Explanation of Provisions ................................................................................ 11

A. Analysis of Legislation and Comparison With Present Law ............ 11

a. Section 1, Short Title, Table of Contents .................................... 11

b. Section 2, Patient Safety Improvements ..................................... 11

c. Section 3, Medical Information Technology Advisory Board ..... 16

III. Votes of the Committee .................................................................................... 18

IV. Budget Effects of the Bill ................................................................................. 19

A. Committee Estimate of Budgetary Effects ........................................ 19

B. Statement Regarding New Budget Authority and Tax Expenditures .................................................................................................... 19

C. Cost Estimate Prepared by the Congressional Budget Office .......... 19

V. Other Matters To Be Discussed Under the Rules of the House ................... 22

A. Committee Oversight Findings and Recommendations .................... 22

B. Constitutional Authority Statement .................................................. 22

C. Information Relating to Unfunded Mandates ................................... 22

D. Summary of General Performance Goals and Objectives ................ 22

VI. Changes in Existing Law Made by the Bill as Reported .............................. 23

The amendment is as follows: 

Strike all after the enacting clause and insert the following:

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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Patient Safety Improvement Act 

of 2002’’. 

(b) TABLE OF CONTENTS.—The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Patient safety improvements. 

‘‘PART D—PATIENT SAFETY IMPROVEMENTS

‘‘Sec. 1181. Voluntary reporting of patient safety data; definitions. 

‘‘Sec. 1182. Confidentiality and peer review protections. 

‘‘Sec. 1183. Center for Quality Improvement and Patient Safety. 

‘‘Sec. 1184. Interoperability standards for health care information technology systems. 

‘‘Sec. 1185. Voluntary adoption of methods to improve patient safety. 

‘‘Sec. 1186. Evaluation and report. 

Sec. 3. Medical Information Technology Advisory Board.

SEC. 2. PATIENT SAFETY IMPROVEMENTS. 

Title XI of the Social Security Act is amended by adding at the end the following 

new part: 

‘‘PART D—PATIENT SAFETY IMPROVEMENTS

‘‘VOLUNTARY REPORTING OF PATIENT SAFETY DATA; DEFINITIONS

‘‘SEC. 1181. (a) COLLECTION AND VOLUNTARY REPORTING OF PATIENT SAFETY

DATA.—In order to improve patient safety and the quality of health care delivery, 

a health care provider (as defined in subsection (d)) may voluntarily collect and develop patient safety data (as defined in subsection (e)) and report such data to one 

or more patient safety organizations (as defined in subsection (f)) in a manner that 

is confidential and privileged (as described in section 1182). 

‘‘(b) USE OF PATIENT SAFETY DATA BY PATIENT SAFETY ORGANIZATIONS.—Patient 

safety organizations shall analyze the patient safety data reported and develop (and 

report back to health care providers) information to improve patient safety and the 

quality of health care delivery and shall submit non-identifiable information derived 

from such data in a uniform manner to the Center for Quality Improvement and 

Patient Safety (for inclusion in the Patient Safety Database, if applicable). Such 

non-identifiable information may be disclosed and shared with other patient safety 

organizations. Identifiable patient safety data may be disclosed to other patient 

safety organizations with the explicit authorization for each such disclosure by the 

reporting provider involved. 

‘‘(c) FUNCTIONS OF CENTER.—The Center for Quality Improvement and Patient 

Safety conducts patient safety activities consistent with section 1183. 

‘‘(d) HEALTH CARE PROVIDERS COVERED.—For purposes of this part, the term 

‘health care provider’ means—

‘‘(1) a provider of services (as defined in section 1861(u) and including a hospital, skilled nursing facility, home health agency, and hospice program) that 

provides services for which payment may be made under part A of title XVIII 

and the provider’s employees; 

‘‘(2) a health care entity or individual that furnishes medical or other health 

services (as defined in section 1861(s)), other services described in section 

1832(a)(2), or other items and services for which payment may be made under 

such title, including a physician (as defined in section 1861(r)); and 

‘‘(3) an organization offering a plan under part C of title XVIII. 

‘‘(e) PATIENT SAFETY DATA COVERED.—

‘‘(1) IN GENERAL.—For purposes of this part, the term ‘patient safety data’

means any data, reports, records, memoranda, analyses, deliberative work, 

statements, or root cause analyses that are collected or developed to improve 

patient safety or health care quality and that—

‘‘(A) are collected or developed by a health care provider for the purpose 

of reporting to a patient safety organization and that are reported on a 

timely basis to such an organization; 

‘‘(B) are collected or developed by a patient safety organization or by (or 

on behalf of) the Center for Quality Improvement and Patient Safety, regardless of whether the data are transmitted to the health care provider 

that reported the original data; or 

‘‘(C) describes corrective actions taken by a health care provider in response to the provider’s reporting of data to that organization, regardless 

of whether the organization has transmitted under subsection (f)(2) information to the health care provider that reported the original data, and that 

are reported on a timely basis to such an organization. 

‘‘(2) CONSTRUCTION REGARDING USE OF DATA.—

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‘‘(A) INTERNAL USE PERMITTED TO IMPROVE PATIENT SAFETY, QUALITY, AND

EFFICIENCY.—Nothing in this part shall be construed to limit or discourage 

a health care provider from developing and using patient safety data within 

the provider to improve patient safety, health care quality, or administrative efficiency of the provider. ‘‘(B) TREATMENT.—Information that is collected or developed as patient 

safety data is not disqualified from being treated as patient safety data because of its development or use for the purposes described in subparagraph 

(A) and such development or use shall not constitute a waiver of any privilege or protection established under section 1182 or under State law. ‘‘(f) QUALIFICATIONS OF PATIENT SAFETY ORGANIZATIONS.— ‘‘(1) IN GENERAL.—For purposes of this part, the term ‘patient safety organization’ means a private or public organization that conducts activities to improve 

patient safety and the quality of health care delivery by assisting health care 

providers that report to such organizations and that has been certified by the 

Secretary as— ‘‘(A) performing each of the activities described in paragraph (2); and 

‘‘(B) meets the other requirements of paragraphs (3) through (5). ‘‘(2) ACTIVITIES DESCRIBED.—The activities referred to in paragraph (1)(A) are 

the following: ‘‘(A) The collection and analysis of patient safety data that are voluntarily 

reported by more than one health care provider on a local, regional, State, 

or national basis. 

‘‘(B) The development and dissemination of information to health care 

providers and other patient safety organizations with respect to improving 

patient safety, such as recommendations, protocols, or information regarding best practices. 

‘‘(C) The utilization of patient safety data to carry out activities under 

this paragraph to improve patient safety and to provide assistance to health 

care providers to minimize patient risk. 

‘‘(3) CONDUCT OF ACTIVITIES.—In conducting activities under paragraph (2), a 

patient safety organization shall—

‘‘(A) maintain confidentiality with respect to individually identifiable 

health information; 

‘‘(B) submit non-identifiable information to the Center for Quality Improvement and Patient Safety in a format established by the Secretary; and 

‘‘(C) maintain appropriate security measures with respect to patient safety data. 

‘‘(4) ORGANIZATION REQUIREMENTS.—The requirements of this paragraph for 

an organization are that—

‘‘(A) the organization is managed, controlled, and operated independently 

from health care providers which report patient safety data to it under this 

part; 

‘‘(B) if the organization no longer qualifies as a patient safety organization, with respect to any patient safety data that it received from a health 

care provider, the organization shall do one of the following: 

‘‘(i) with the approval of the provider and another patient safety organization, transfer such data to such other organization; 

‘‘(ii) if practicable, return the data to the provider; or 

‘‘(iii) destroy the patient safety data; 

‘‘(C) if the organization charges a fee for the activities it performs with 

respect to health care providers, the fee shall be uniform among all classes 

or types of health care providers (taking into account the size of the health 

care provider); 

‘‘(D) the organization seeks to collect data from health care providers in 

a standardized manner that permits valid comparisons of similar cases 

among similar health care providers; and 

‘‘(E) the organization meets such other requirements as the Secretary 

may by regulation require. 

For purposes of subparagraph (A), an organization is controlled by a health care 

provider if the provider is able to significantly influence or direct the actions 

or policies of the organization. 

‘‘(5) LIMITATION ON USE OF PATIENT SAFETY DATA BY PATIENT SAFETY ORGANIZATIONS.—A patient safety organization may not use patient safety data reported by a health care provider in accordance with this part to take regulatory 

or enforcement actions it otherwise performs (or is responsible for performing) 

in relation to such provider. 

‘‘(6) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance 

to patient safety organizations in providing recommendations and advice to 

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health care providers reporting patient safety data under this part. Such assistance shall include advice with respect to methodology, communication, dissemination of information, data collection, security, and confidentiality concerns. ‘‘(g) CONSTRUCTION.—Nothing in this part shall be construed to limit or discourage the reporting of information relating to patient safety within a health care provider. 

‘‘CONFIDENTIALITY AND PEER REVIEW PROTECTIONS

‘‘SEC. 1182. (a) IN GENERAL.—Notwithstanding any other provision of law, patient 

safety data shall be privileged and confidential in accordance with this section. ‘‘(b) SCOPE OF PRIVILEGE.—Subject to the succeeding provisions of this section, 

such data shall not be— ‘‘(1) subject to a civil or administrative subpoena; 

‘‘(2) subject to discovery in connection with a civil or administrative proceeding; ‘‘(3) disclosed pursuant to section 552 of title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal 

or State law; or ‘‘(4) admitted as evidence or otherwise disclosed in any civil or administrative 

proceeding. ‘‘(c) CLARIFICATION OF SCOPE.—The privilege established by this section with respect to patient safety data described in section 1181(e)(1)(A) shall apply to information, such as records of a patient’s medical diagnosis and treatment, other primary 

health care information, and other information, to the extent that such information 

was collected or developed for the purpose specified in such section and is reported 

in accordance with such section. Such privilege shall not apply to information merely by reason of its inclusion, or the fact of its submission, in a report under such 

section. Information available from sources other than a report made under such 

section may be discovered or admitted in a civil or administrative proceeding, if discoverable or admissible under applicable state law. ‘‘(d) INFORMATION NOT SUBJECT TO PRIVILEGE.—The privilege established by this 

section shall not apply to one or more of the following: ‘‘(1) MEDICAL RECORDS AND OTHER PRIMARY HEALTH RECORDS.—Records of a 

patient’s medical diagnosis and treatment and other primary health records of 

a health care provider. Such privilege shall not apply to such information by 

reason of its inclusion within patient safety data. ‘‘(2) FDA.—Relevant information disclosed by a health care provider or patient safety organization to the Food and Drug Administration, or to a person 

that is subject to the jurisdiction of such Administration, with respect to an Administration-regulated product or activity for which that entity has responsibility, for the purposes of activities related to quality, safety, or effectiveness of 

such Administration-regulated product or activity, subject to section 520(c) of 

the Federal Food, Drug, and Cosmetic Act. ‘‘(3) NON-IDENTIFIABLE INFORMATION USED BY DATABASE.—Non-identifiable information from a patient safety organization to the Patient Safety Database and 

the further disclosure of such data by the Center for Quality Improvement and 

Patient Safety. ‘‘(e) REPORTER PROTECTION.— ‘‘(1) IN GENERAL.—A health care provider may not use against an individual 

in an adverse employment action described in paragraph (2) the fact that the 

individual in good faith reported— ‘‘(A) to the provider with the intention of having it reported to a patient 

safety organization, or 

‘‘(B) directly to a patient safety organization, 

information that would constitute patient safety data under section 

1181(e)(1)(A) if the provider were to have submitted it on a timely basis to a 

patient safety organization in accordance with such section. 

‘‘(2) ADVERSE EMPLOYMENT ACTION.—For purposes of this subsection, an ‘adverse employment action’ includes—

‘‘(A) the failure to promote an individual or provide any other employment-related benefit for which the individual would otherwise be eligible; 

‘‘(B) an evaluation or decision made in relation to accreditation, certification, credentialing or licensing of the individual; and 

‘‘(C) a personnel action that is adverse to the individual concerned. 

‘‘(3) REMEDIES.—The provisions of the first sentence of section 1128A(a) shall 

apply with respect to a health care provider’s violation of paragraph (1) in the 

same manner as they apply to an act referred to in section 1128A(a)(7). 

‘‘(f) PENALTY.—It is unlawful for any person to disclose any patient safety data 

in violation of the provisions of this section. Any person violating such provisions 

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shall subject to the same sanctions under section 1160(c) (relating to, upon conviction, a fine of not more than $1,000, imprisonment for not more than 6 months, or 

both, per disclosure and payment of the costs of prosecution) as a person who discloses any information described in section 1160(a). 

‘‘(g) RULES OF CONSTRUCTION.—

‘‘(1) NO LIMITATION OF OTHER PRIVILEGES.—Subject to paragraph (2), nothing 

in this section shall be construed as affecting other privileges that are available 

under Federal or State laws that provide greater peer review or confidentiality 

protections than the peer review and confidentiality protections provided for in 

this section. 

‘‘(2) NO EFFECT ON STATE MANDATORY REPORTING REQUIREMENTS.—Nothing in 

this part shall be construed as preempting or otherwise affecting any State law 

mandatory reporting requirement for health care providers. 

‘‘(h) APPLICATION OF PRIVACY REGULATIONS.—For purposes of applying the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability 

and Accountability Act of 1996 (Public Law 104-191; 110 Stat. 2033)—

‘‘(1) patient safety organizations shall be treated as business associates; 

‘‘(2) activities of such organizations described in section 1181(f)(2)(A) in relation to a health care provider are deemed to be health care operations of the 

provider; and 

‘‘(3) the disclosure of identifiable information under the voluntary program 

under this part by such an organization shall be treated as necessary for the 

proper management and administration of the organization. 

Nothing in this section shall be construed to alter or affect the implementation of 

such regulation or such section 264(c). 

‘‘(i) WAIVERS.—Nothing in this part shall be construed as precluding a health care 

provider from waiving the privilege or confidentiality protections under this section. 

Disclosure of patient safety data under subsection (d)(2) shall not constitute a waiver of any privilege or protection established under this section or under State law. 

‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety data of an organization that is 

certified as a patient safety organization shall continue to be privileged and confidential, in accordance with this section, if the organization’s certification is terminated or revoked or if the organization otherwise ceases to qualify as a patient safety organization until the data are otherwise disposed of in accordance with section 

1181(f)(4). 

‘‘(k) SURVEY AND REPORT.— ––

‘‘(1) SURVEY.—The Comptroller General of the United States shall conduct a 

survey of State laws that relate to patient safety data peer review systems, including laws that establish an evidentiary privilege applicable to data developed 

in such systems, and shall review the manner in which such laws have been 

interpreted by the courts and the effectiveness of such laws in promoting patient safety. 

‘‘(2) REPORT.—Not later than 9 months after the date of enactment of this section, the Comptroller General shall prepare and submit to Congress a report 

concerning the results of the survey conducted under paragraph (1). 

‘‘CENTER FOR QUALITY IMPROVEMENT AND PATIENT SAFETY

‘‘SEC. 1183. (a) IN GENERAL.—The Secretary, acting through the Director of the 

Agency for Healthcare Research and Quality, shall ensure that the Center for Quality Improvement and Patient Safety (in this section referred to as the ‘Center’) supports public and private sector initiatives to improve patient safety for items and 

services furnished through health care providers. 

‘‘(b) DUTIES.—

‘‘(1) IN GENERAL.—The Secretary, acting through the Director, shall ensure 

that the Center carries out the following duties: 

‘‘(A) Provide for the certification and recertification of patient safety organizations in accordance subsection (d). 

‘‘(B) Collect and disseminate information related to patient safety. 

‘‘(C) Establish a Patient Safety Database to collect, support, and coordinate the analysis of non-identifiable information submitted to the Database 

in accordance with subsection (e). 

‘‘(D) Facilitate the development of consensus among health care providers, patients, and other interested parties concerning patient safety and 

recommendations to improve patient safety. 

‘‘(E) Provide technical assistance to States that have (or are developing) 

medical errors reporting systems, assist States in developing standardized 

methods for data collection, and collect data from State reporting systems 

for inclusion in the Patient Safety Database. 

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‘‘(2) CONSULTATION.—In carrying out the duties under paragraph (1) (including the establishment of the Database), the Secretary shall consult with and develop partnerships, as appropriate, with health care organizations, health care 

providers, public and private sector entities, patient safety organizations, health 

care consumers, and other relevant experts to improve patient safety. ‘‘(c) CERTIFICATION AND RECERTIFICATION PROCESS.— ‘‘(1) IN GENERAL.—The initial certification and recertification of a patient safety organization under subsection (b)(1)(A) shall be made under a process that 

is approved by the Secretary and is consistent with criteria published by the 

Secretary. ‘‘(2) REVOCATION.—Such a certification or recertification may be revoked by 

the Secretary upon a showing of cause (including the disclosure of data in violation of section 1182). ‘‘(3) TERMINATION.—Such a certification provided for a patient safety organization shall terminate (subject to recertification) on the earlier of— ‘‘(A) the date that is 3 years after the date on which such certification 

was provided; or ‘‘(B) the date on which the Secretary revokes the certification. ‘‘(d) IMPLEMENTATION AND CONSULTATION.—In carrying out subsection (c)(1), the 

Secretary shall— ‘‘(1) facilitate the development of patient safety goals and track the progress 

made in meeting those goals; and ‘‘(2) ensure that data submitted by a patient safety organization to the Patient Safety Database, as provided for under subsection (e), are comparable and 

useful for research and analysis and that the research findings and patient safety alerts that result from such analyses are presented in clear and consistent 

formats that enhance the usefulness of such alerts. ‘‘(e) PATIENT SAFETY DATABASE.— ‘‘(1) IN GENERAL.—The Secretary, acting through the Director, shall— ‘‘(A) establish a Patient Safety Database to collect non-identifiable information concerning patient safety that is reported on a voluntary basis; and ‘‘(B) establish common formats for the voluntary reporting of data under 

subparagraph (A), including the establishment of necessary data elements, 

common and consistent definitions, and a standardized computer interface 

for the processing of such data. ‘‘(2) DATABASE.—In carrying out this subsection, the Secretary— ‘‘(A) shall establish and modify as necessary criteria to determine the organizations that may voluntarily contribute to, and the data that comprises, 

the Patient Safety Database; ‘‘(B) shall ensure that the Patient Safety Database is only used by qualified entities or individuals as determined appropriate by the Secretary in 

accordance with criteria applied by the Secretary; and ‘‘(C) may enter into contracts for the administration of the Database with 

private and public entities with experience in the administration of similar 

databases. ‘‘(3) NON-IDENTIFIABLE INFORMATION.—For purposes of this part, the term ‘non-identifiable information’ means information that is presented in a form and 

manner that prevents the identification of any health care provider, patient, 

and the reporter of the information. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated 

such sums as may be necessary for each fiscal year to carry out this section. 

‘‘INTEROPERABILITY STANDARDS FOR HEALTH CARE INFORMATION TECHNOLOGY

SYSTEMS

‘‘SEC. 1184. (a) IN GENERAL.—By not later than 2 years after the date of the enactment of this part, the Secretary shall develop or adopt (and shall periodically review and update) voluntary, national standards that promote the interoperability of 

health care information technology systems across all health care settings. In promulgating regulations to carry out this section, the Secretary shall take into account 

the cost that meeting such standards would have on providing health care in the 

United States and the increased efficiencies in providing such care achieved under 

the standards. 

‘‘(b) CONSULTATION AND COORDINATION.—The Secretary shall develop and update 

such standards in consultation with (and with coordination between)—

‘‘(1) the National Committee for Vital and Health Statistics, and 

‘‘(2) the Medical Information Technology Advisory Board (established under 

section 3 of the Patient Safety Improvement Act of 2002). 

‘‘(c) DISSEMINATION.—The Secretary shall provide for the dissemination of the 

standards developed and updated under this section. 

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‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for each fiscal year to carry out this section. 

‘‘VOLUNTARY ADOPTION OF METHODS TO IMPROVE PATIENT SAFETY

‘‘SEC. 1185. The Secretary shall encourage health care providers to adopt appropriate evidence-based methods to improve patient safety. Such methods shall not 

constitute national practice guidelines. 

‘‘EVALUATION AND REPORT

‘‘SEC. 1186. (a) EVALUATION.—The Comptroller General of the United States shall 

conduct a comprehensive evaluation of the implementation of this part. Such evaluation shall include an examination of the following: ‘‘(1) The health care providers that reported patient safety data under this 

part and the patient safety organizations to which they reported the information. ‘‘(2) What types of events were so reported on. 

‘‘(3) The usefulness of the analyses, information, and recommendations provided by patient safety organizations in response to such reported information. ‘‘(4) The response of health care providers to such analyses, information, and 

recommendations, including a survey of providers to obtain estimates of the percentage of providers by category who have adopted specific error-reduction 

methods and, if applicable, reasons for not adopting specific practices. ‘‘(5) The effectiveness of the program under this part in reducing medical er- rors. ‘‘(b) REPORT.—Not later than 5 years after the date the provisions of this part are 

first implemented, the Comptroller General shall submit to Congress a report on the 

evaluation conducted under subsection (a).’’. 

SEC. 3. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD. 

(a) ESTABLISHMENT.— (1) IN GENERAL.—Not later than 3 months after the date of the enactment of 

this Act, the Secretary of Health and Human Services (in this section referred 

to as the ‘‘Secretary’’) shall appoint an advisory board to be known as the ‘‘Medical Information Technology Advisory Board’’ (in this section referred to as the ‘‘MITAB’’). 

(2) CHAIRMAN.—The Secretary shall designate one member as chairman. The 

chairman shall be an individual affiliated with an organization having expertise 

creating American National Standards Institute (ANSI) accepted standards in 

health care information technology and a member of the National Committee 

for Vital and Health Statistics. 

(b) COMPOSITION.— (1) IN GENERAL.—The MITAB shall consist of not more than 17 members that 

include—

(A) experts from the fields of medical information, information technology, medical continuous quality improvement, medical records security 

and privacy, individual and institutional health care clinical providers, 

health researchers, and health care purchasers; 

(B) one or more staff experts from each of the following: the Centers for 

Medicare & Medicaid Services, the Agency for Healthcare Research and 

Quality, and the Institute of Medicine of the National Academy of Sciences; 

(C) representatives of private organizations with expertise in medical 

infomatics; 

(D) a representative of a teaching hospital; and 

(E) one or more representatives of the health care information technology 

industry. 

(2) TERMS OF APPOINTMENT.—The term of any appointment under paragraph 

(1) to the MITAB shall be for the life of the MITAB. 

(3) MEETINGS.—The MITAB shall meet at the call of its chairman or a majority of its members. 

(4) VACANCIES.—A vacancy on the MITAB shall be filled in the same manner 

in which the original appointment was made not later than 30 days after the 

MITAB is given notice of the vacancy and shall not affect the power of the remaining members to execute the duties of the MITAB. 

(5) COMPENSATION.—Members of the MITAB shall receive no additional pay, 

allowances, or benefits by reason of their service on the MITAB. 

(6) EXPENSES.—Each member of the MITAB shall receive travel expenses and 

per diem in lieu of subsistence in accordance with sections 5702 and 5703 of 

title 5, United States Code. 

(c) DUTIES.—

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(1) IN GENERAL.—The MITAB shall on an ongoing basis advise, and make recommendations to, the Secretary regarding medical information technology, including the following: 

(A) The best current practices in medical information technology. 

(B) Methods for the adoption (not later than 2 years after the date of the 

enactment of this section) of a uniform health care information system 

interface between and among old and new computer systems. 

(C) Recommendations for health care vocabulary, messaging, and other 

technology standards (including a common lexicon for computer technology) 

necessary to achieve the interoperability of health care information systems 

for the purposes described in subparagraph (E). 

(D) Methods of implementing— (i) health care information technology interoperability standardization; and 

(ii) records security. 

(E) Methods to promote information exchange among health care providers so that long-term compatibility among information systems is maximized, in order to do one or more of the following: 

(i) To maximize positive outcomes in clinical care— (I) by providing decision support for diagnosis and care; and 

(II) by assisting in the emergency treatment of a patient presenting at a facility where there is no medical record for the patient. 

(ii) To contribute to (and be consistent with) the development of the 

patient assessment instrument provided for under section 545 of the 

Medicare, Medicaid, and SCHIP Benefits Improvement and Protection 

Act of 2000, and to assist in minimizing the need for new and different 

records as patients move from provider to provider. 

(iii) To reduce or eliminate the need for redundant records, paperwork, and the repetitive taking of patient histories and administering 

of tests. 

(iv) To minimize medical errors, such as administration of contraindicated drugs. 

(v) To provide a compatible information technology architecture that 

facilitates future quality and cost-saving needs and that avoids the financing and development of information technology systems that are 

not readily compatible. 

(2) REPORTS.—

(A) INITIAL REPORT.—No later than 18 months after the date of the enactment of this Act, the MITAB shall submit to Congress and the Secretary 

an initial report concerning the matters described in paragraph (1). The report shall include—

(i) the practices described in paragraph (1)(A), including the status 

of health care information technology standards being developed by private sector and public-private groups; 

(ii) recommendations for accelerating the development of common 

health care terminology standards; 

(iii) recommendations for completing development of health care information system messaging standards; and 

(iv) progress toward meeting the deadline described in paragraph 

(1)(B) for adoption of methods described in such paragraph. 

(B) SUBSEQUENT REPORTS.—During each of the 2 years after the year in 

which the report is submitted under subparagraph (A), the MITAB shall 

submit to Congress and the Secretary an annual report relating to additional recommendations, best practices, results of information technology 

improvements, analyses of private sector efforts to implement the interoperability standards established in section 1184 of the Social Security Act, and 

such other matters as may help ensure the most rapid dissemination of best 

practices in health care information technology. 

(d) STAFF AND SUPPORT SERVICES.—

(1) EXECUTIVE DIRECTOR.—

(A) APPOINTMENT.—The Chairman shall appoint an executive director of 

the MITAB. 

(B) COMPENSATION.—The executive director shall be paid the rate of basic 

pay for level V of the Executive Schedule. 

(2) STAFF.—With the approval of the MITAB, the executive director may appoint such personnel as the executive director considers appropriate. 

(3) APPLICABILITY OF CIVIL SERVICE LAWS.—The staff of the MITAB shall be 

appointed without regard to the provisions of title 5, United States Code, govVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00008 Fmt 6659 Sfmt 6621 E:\HR\OC\HR714P1.XXX HR714P1
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erning appointments in the competitive service, and shall be paid without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such 

title (relating to classification and General Schedule pay rates). 

(4) EXPERTS AND CONSULTANTS.—With the approval of the MITAB, the executive director may procure temporary and intermittent services under section 

3109(b) of title 5, United States Code. 

(e) POWERS.—

(1) HEARINGS AND OTHER ACTIVITIES.—For the purpose of carrying out its duties, the MITAB may hold such hearings and undertake such other activities 

as the MITAB determines to be necessary to carry out its duties. 

(2) DETAIL OF FEDERAL EMPLOYEES.—Upon the request of the MITAB, the 

head of any Federal agency is authorized to detail, without reimbursement, any 

of the personnel of such agency to the MITAB to assist the MITAB in carrying 

out its duties. Any such detail shall not interrupt or otherwise affect the civil 

service status or privileges of the Federal employee. 

(3) TECHNICAL ASSISTANCE.—Upon the request of the MITAB, the head of a 

Federal agency shall provide such technical assistance to the MITAB as the 

MITAB determines to be necessary to carry out its duties. 

(4) OBTAINING INFORMATION.—The MITAB may secure directly from any Federal agency information necessary to enable it to carry out its duties, if the information may be disclosed under section 552 of title 5, United States Code. 

Upon request of the Chairman of the MITAB, the head of such agency shall furnish such information to the MITAB. 

(f) TERMINATION.—The MITAB shall terminate 30 days after the date of submission of its final report under subsection (c)(2)(B). 

(g) APPLICABILITY OF FACA.—The provisions of the Federal Advisory Committee 

Act (5 U.S.C. App.) shall apply to the MITAB. 

(h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated 

to the Secretary of Health and Human Services such sums as are necessary to carry 

out this section.

I. INTRODUCTION 

A. PURPOSE AND SUMMARY

PURPOSE

More than three years ago, the Institute of Medicine (IOM) reported that preventable medical errors are the eighth leading cause 

of death in America—ahead of breast cancer, AIDS, and traffic 

deaths. Up to 100,000 patients die in hospitals each year as a result of preventable mistakes. The number of injured is far greater. 

A recent report by Auburn University analyzed data from 36 hospitals and nursing homes in Colorado and Georgia over an 81–day 

period and found medication errors in about 20 percent of the doses 

administered in a ‘‘typical’’ 300–bed facility; researchers considered 

seven percent of the errors ‘‘potentially harmful.’’

Not only can avoidable patient errors result in poorer health outcomes—the most dramatic being death—they often drive up health 

costs by requiring expensive medical interventions to correct the 

subsequent medical problems. For example, adverse drug events 

(ADEs) and interactions in hospitals are prevalent and costly, yet 

could be dramatically reduced by adopting technology to reduce 

prescribing errors. 

According to the Pittsburgh Regional Healthcare Initiative, medication errors result in $3,500 to $4,000 in additional costs per incident. According to estimates from Cardinal Health, Inc., there were 

more than 625,000 preventable ADEs in hospitals in 2000 at a cost 

of $2.9 billion. The IOM also estimates that medical errors cost the 

economy about $38 billion each year, of which $17 billion is the result of preventable errors. 

10

These unacceptable financial costs are borne by providers, individuals, insurers and employers and public programs such as Medicare. 

The purpose of the bill is to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect health outcomes. Specifically, this act will encourage a culture 

of safety by providing for the legal protection of information reported voluntarily for the purposes of quality improvement and the 

reduction of medical errors.

B. LEGISLATIVE HISTORY

In the 106th Congress, the Subcommittee on Health held a hearing on the prevalence and nature of medical errors on February 10, 

2002. During the 107th Congress, the Subcommittee on Health 

held a hearing on March 7, 2002 (107–76), on improving health 

quality by reducing the incidence and prevalence of medical errors. 

At that hearing, a number of experts testified to the Committee. 

Specifically, Dr. James Bagian, Director, National Center for Patient Safety, Department of Veterans Affairs, testified the VA has 

adopted a successful reporting system that has improved patient 

safety. Also, Dr. Karen Wolk Feinstein, Chair of the Pittsburgh Regional Healthcare Initiative, testified as to the Initiative’s success 

in implementing an ambitious zero tolerance policy for medical errors and how a voluntary, confidential reporting system will help 

reduce medical errors by promoting a culture of safety. 

Academic expert Donald M. Berwick, the President and CEO of 

the Institute for Healthcare Improvement testified limited reporter 

protections and new information technology standards will promote 

better clinical outcomes, and the adoption of computerized physician order entry technology for electronic prescribing is critical to 

reduce avoidable medication errors. Dr. Matthew Alan Miller from 

Danbury Hospital (Connecticut), testified on behalf of the American 

Hospital Association on their perspectives to improve health outcomes and patient safety. Dr. Miller testified additional resources 

should be added to Medicare to encourage the purchase of information technology. Lastly, Mary Foley, President of the American 

Nurses Association, focused her testimony on mandatory overtime 

and dangerous working conditions in health facilities that lead to 

medical errors. 

The information gained from that hearing led to the introduction 

of H.R. 4889, the ‘‘Patient Safety Improvement Act of 2002,’’ that 

would provide incentives to report error information and glean 

knowledge about medical mistakes and system failures in order to 

reduce medical errors. 

On September 10, 2002, the Subcommittee on Health held a legislative hearing on the draft substitute amendment to H.R. 4889. 

At the hearing Health and Human Services Secretary Tommy 

Thompson expressed the Administration’s strong support for H.R. 

4889. Testifying with Secretary Thompson was Carolyn Clancy, 

Acting Director of the Agency for Healthcare Research and Quality, 

which is the primary federal agency responsible for quality improvement and patient safety. In addition, letters of support from 

Secretary Thompson, Treasury Secretary Paul O’Neil, Centers for 

Medicare and Medicaid Services Administrator Tom Scully and Director Clancy for H.R. 4889 were presented at the hearing. 

11

Dr. Lucian Leape of Harvard University testified that error reporting for all but the most serious events should be voluntary and 

confidential and that certain changes needed to be made in the underlying bill prior to his support. Those changes were made. It is 

important to note that Dr. Leape was one of the authors of the 

1999 Institute of Medicine report. 

Michael B. Wood, President and Chief Executive Officer of the 

Mayo Foundation, testified on behalf of the Healthcare Leadership 

Council. He stated that reporting systems should be voluntary and 

confidential, and that the Secretary should develop standards for 

the interoperability of health information technology in order to reduce medical mistakes and improve health outcomes. 

Ken Segel, Director of the Pittsburgh Regional Healthcare Initiative, testified that mandatory reporting should not be pursued prior 

to a voluntary, confidential and cooperative approach had been 

tested. In addition, Herbert Pardes, President of New York-Presbyterian, and Chief Executive Officer of the New York-Presbyterian 

Healthcare System testified that the interoperability and Advisory 

Board provisions of H.R. 4889 are critical to promoting the adoption of information technology to reduce medical errors. Lastly, the 

Committee heard from Jill Rosenthal who is a Project Manager at 

the National Academy for State Health Policy and who encouraged 

the Committee to protect state laws in this area and provide support for current and future efforts. 

On September 12, 2002, the Subcommittee on Health ordered favorably reported to the full Committee H.R. 4889, the ‘‘Patient 

Safety Improvement Act of 2002,’’ on a voice vote with a quorum 

present. 

On September 18, 2002, the Full Committee on Ways and Means 

ordered favorably reported H.R. 4889, the ‘‘Patient Safety Improvement Act,’’ as amended, by a recorded vote of 33 to 4.

II. EXPLANATION OF PROVISIONS 

A. ANALYSIS OF LEGISLATION AND COMPARISON WITH PRESENT LAW

Section 1. Short title; table of contents 

Current Law. No provision. 

Explanation of Provision. The legislation would be cited as the 

Patient Safety Improvement Act of 2002 and would amend Title XI 

of the Social Security Act by adding Part D—Patient Safety Improvements—with six new sections (Sections 1181–1186). A Medical Information Technology Advisory Board would also be established. 

Reason for Change. Not applicable. 

Effective Date. Upon enactment. 

Section 2. Patient safety improvements 

Current Law. No statutory provisions. The Institute of Medicine’s 

(IOM) 1999 report, To Err is Human, focused attention on the 

problem of preventable medical errors and the need for systematic 

steps to reduce their incidence to enhance patient safety. Among 

other proposals, IOM recommended that Congress create a Center 

for Patient Safety within the Agency for Healthcare Research and 

Quality (then called the Agency for Health Care Policy and ReVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00011 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
12

search) to promote knowledge and prevention of medical errors, set 

national goals for patient safety, fund patient safety research, 

evaluate methods for identifying and preventing medical errors, 

disseminate information on effective safety practices, and issue an 

annual report to the President and Congress on patient safety. The 

IOM recommended two systems for identifying and learning from 

medical errors. First, they recommended a nationwide, mandatory 

reporting system for serious adverse events such as death. The 

IOM also recommended a voluntary reporting system for less serious errors, or for situations that could be prevented. The Committee has addressed the later recommendation, based on the advice of numerous experts, academicians and providers. In addition, 

the IOM recommended that the Center for Patient Safety encourage the development of voluntary reporting systems and outlined 

various actions that could be undertaken. Furthermore, IOM recommended that Congress pass legislation to extend peer review 

protections to information collected under such voluntary systems. 

While existing law often shields data about errors within a given 

institution, the IOM report noted that this protection may be lost 

if the information is transmitted elsewhere, even to a voluntary reporting system serving as the backbone of a collaborative effort to 

reduce medical errors. 

Explanation of Provision. The provision would establish a new 

Part D in Title XI of the Social Security Act to encourage a voluntary reporting system for patient safety data. 

A new Section 1181 would be added that would permit a health 

care provider to voluntarily collect, develop and report patient safety data to a patient safety organization in a manner that is confidential and privileged. Patient safety organizations would analyze 

the reported data, report back to providers information to improve 

patient safety, and submit non-identifiable information to the Center for Quality Improvement and Patient Safety for inclusion in the 

Patient Safety Database. Patient safety organizations would be 

permitted to share non-identifiable information, but the disclosure 

of identifiable information from one such organization to another 

would require for each disclosure the explicit authorization of the 

provider who initially reported the information, and the information could only be shared for purposes consistent with the Act. 

In this legislation, a health care provider would mean: (1) facilities and their employees that provide services under Medicare Part 

A; (2) a health care entity or individual (including a physician) who 

furnishes Medicare Part B services; and (3) an organization offering a Medicare+Choice plan. 

Patient safety data would mean any data, reports, records, 

memoranda, analyses, deliberative work, statements, or root cause 

analyses that are collected or developed to improve patient safety 

or health care quality. That would include patient safety data collected or developed by a provider to report to a patient safety organization on a timely basis, as well as data collected or developed 

by a patient safety organization or by or on behalf of the Center 

for Quality Improvement and Patient Safety, regardless of whether 

the data are transmitted back to the health care provider that supplied the information originally. Patient safety data would also encompass descriptions of corrective actions taken by providers in response to the provider’s reporting of data to a patient safety organiVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00012 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
13

zation (on a timely basis to such an organization), regardless of 

whether the organization has provided feedback to the provider. To 

further knowledge, providers would have to report the corrective 

actions to the patient safety organization. Nothing in the bill 

should be construed as limiting a provider’s ability to waive the 

privilege or confidentiality protections established by the legislation. 

A patient safety organization (PSO) would mean a private or 

public organization that conducts activities to improve patient safety and health care quality by assisting health care entities that report to them. Such entities must meet certain requirements and be 

certified by the Secretary. Activities performed by the PSO would 

include: (1) the collection and analysis of patient safety data that 

are voluntarily reported by more than one provider on a local, 

state, regional, or national basis; (2) the development of and dissemination to providers and other patient safety organizations information such as recommendations, protocols, and best practice 

data; and (3) the utilization of patient safety data to help providers 

minimize patient risk. Patient safety organizations would be required to ensure the confidentiality of individually identifiable 

health information, submit non-identifiable information to the Center for Quality Improvement and Patient Safety, if applicable, in a 

format established by the Secretary, and maintain appropriate data 

security measures. 

Such organizations would also be required: (1) to be managed, 

controlled (i.e. the provider is able to significantly influence or direct its actions or policies), and operated independently from providers that report data to it; (2) to collect data from providers in 

a standardized manner to facilitate comparisons of similar cases 

across similar providers; and (3) to meet other requirements specified by the Secretary. An entity that no longer qualified as a patient safety organization would be required to destroy its patient 

safety data, return (if practicable) the data to the reporting providers, or transfer data to another patient safety organization with 

the approval of the provider and that organization. Patient safety 

organizations that charge fees for their activities would be required 

to impose a uniform fee across all types and classes of providers, 

taking into account the size of the health care provider. A patient 

safety organization could not use data reported by a provider to 

take regulatory or enforcement actions it otherwise performs in relation to the provider, though the Committee does not intend for 

this to interfere with established oversight and regulatory activities. The Secretary would be able to give technical assistance to patient safety organizations in providing recommendations and advice 

to providers on methodology, communication, data collection, dissemination of information, security and confidentiality concerns. 

Nothing in this part would be construed to limit or discourage reporting patient safety data within a health care provider. 

A new Section 1182 would designate patient safety data as privileged and confidential. That designation would apply to information, such as medical records and other primary health care information, to the extent it was collected and developed for the purpose 

of improving patient safety and health care quality, and reported 

to a patient safety organization on a timely basis. Such privilege 

would not apply to information merely by reason of its inclusion in 

14

reported patient safety data. Information available from sources 

other than a report made under such section may be discovered or 

admitted in a civil or administrative proceeding, if discoverable or 

admissible under applicable state law. With some limitations under 

this new privilege, patient safety data would not be subject to: (1) 

a civil or administrative subpoena; (2) discovery in connection with 

a civil or administrative proceeding; (3) disclosure pursuant to a 

Freedom of Information Act request; or (4) admission as evidence 

or disclosure in any civil or administrative proceeding. 

The privilege established by this section would not apply to: (1) 

Records of a patient’s medical diagnosis and treatment and other 

primary health records of a health care provider; (2) information 

disclosed by a provider or patient safety organization of data to the 

Food and Drug Administration (FDA), or to a person subject to 

FDA jurisdiction, regarding an FDA-regulated product or activity; 

and (3) disclosures of non-identifiable information from a patient 

safety organization to the Patient Safety Database and the further 

disclosure of such information by the Center for Quality Improvement and Patient Safety. Disclosures in violation of the provisions 

of this section would be unlawful. Persons found in violation would 

be subject to the same penalties as those relating to inappropriate 

disclosures made by peer review organizations under the Medicare 

program, which provide for fines of up to $1,000 per disclosure, up 

to six months in prison, or both, and payment of the costs of prosecution. A health care provider would not be permitted to take an 

adverse employment action, including actions related to licensing 

or credentialing, against an individual who reported patient safety 

data to a patient safety organization. A health care provider who 

does undertake such retaliation may be subject to civil monetary 

penalties up to $50,000 in the same manner they are applied in the 

Social Security Act relating to illegal kickbacks. 

Nothing in this part would be construed as preempting or otherwise affecting any state mandatory reporting requirements for 

health care providers. Consistent with protecting state mandatory 

reporting requirements, nothing shall be construed as affecting 

other privileges that are available under Federal or State laws that 

provide greater peer review protection than the peer review and 

confidentiality protections provided under this bill.

The health information privacy provisions in the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and related implementing regulations would not be affected by this legislation. Disclosure of individually identifiable health information 

under this bill would fall under the same confidentiality protections 

required by the HIPAA confidentiality rule as any other disclosure 

of individually identifiable health information (e.g. providers would 

be subject to the Rule’s minimum necessary requirements). The 

Committee believes it is unnecessary for providers to report, and 

PSOs to collect, patient safety data that includes a patient’s name 

or Social Security number. Patient safety organizations would be 

treated as business associates under HIPAA’s privacy rule. 

Permissible disclosures to FDA under these provisions would not 

waive any privilege established by this legislation or under State 

law. Patient safety data of an organization that loses its certification as a patient safety organization would continue to be privileged and confidential until returned to the providers that supplied 

15

the data, transferred to another patient safety organization, or otherwise destroyed. 

The GAO would be required to conduct a survey of State laws regarding patient safety peer review systems, evidentiary privilege 

applicable to data developed in such systems, court interpretations 

of such laws, and the effectiveness of such laws in promoting patient safety. The GAO would be required to submit a report on this 

subject to Congress within nine months of enactment. 

Under Section 1183, the Secretary, through the existing Center 

for Quality Improvement and Patient Safety in the Agency for 

Healthcare Research and Quality, would be required to: (1) provide 

for the certification and recertification of patient safety organizations; (2) collect and disseminate information related to patient 

safety; (3) establish a Patient Safety Database to collect, support 

and coordinate the analysis of non-identifiable information submitted to the database; and (4) facilitate the development of consensus among providers and interested parties concerning patient 

safety and related recommendations. The Secretary, acting through 

the director of the Agency for Healthcare Research and Quality 

would be required to consult with and develop appropriate partnerships with health care organizations, providers, public and private 

sector entities, patient safety organizations, health care consumers 

and other relevant experts. 

The Secretary would certify patient safety organizations under a 

process consistent with published criteria. The Secretary would be 

able to revoke such certification upon a showing of cause, including 

the inappropriate disclosure of patient safety data. Certification 

would terminate, subject to recertification, upon three years from 

the date of certification or upon revocation. In carrying out these 

responsibilities, the Secretary would be required to facilitate the 

development of patient safety goals, track progress in meeting 

these goals, ensure that data submitted by a patient safety organization to the Patient Safety Database are comparable and useful 

for research and analysis, and ensure that research findings and 

patient safety alerts are presented in clear and consistent formats. 

The Secretary, acting through the Center, would: (1) establish a 

Patient Safety Database to collect voluntarily reported, non-identifiable information concerning patient safety; and (2) establish common formats for PSOs reporting data to the Patient Safety Database. The Secretary would also be required to establish criteria to 

determine the organizations and individuals that may voluntarily 

contribute to, and the data that comprises, the Patient Safety 

Database, and to ensure that the database is only used by qualified 

entities and individuals. The Secretary would also be permitted to 

enter into contracts with private and public entities to administer 

the database. Non-identifiable information would mean information 

that is presented in a form that precludes the identification of any 

provider, patient, or reporter of the information. There would be 

authorized to be appropriated such sums as may be necessary for 

each fiscal year to carry out this section. 

A new Section 1184 would require the Secretary within two years 

of enactment to develop or adopt (and periodically review and update) voluntary, national standards that promote the interoperability of health care information technology systems across all 

health care settings. The Secretary must take into account the 

16

costs to the health care system and any efficiencies that accrue as 

a result of the adoption of these standards. These standards would 

be developed in consultation with the National Committee for Vital 

and Health Statistics, and the Medical Information Technology Advisory Board (established under Section 3). The Secretary would be 

required to disseminate these standards. The Secretary is encouraged to use existing demonstration authority to test standards 

across health settings. In doing so, the Secretary should consult 

with the Medical Information Technology Advisory Board established under Section 3. There would be authorized to be appropriated such sums as may be necessary for each fiscal year to carry 

out this section.

A new Section 1185 would require the Secretary to encourage 

providers to adopt appropriate evidence-based methods to improve 

patient safety. These methods would not constitute national practice guidelines. 

A new Section 1186 would require GAO to conduct a comprehensive evaluation of the implementation of Sections 1181–1185 and 

report to Congress within five years of enactment. Such an evaluation would include: (1) an examination of the health care providers 

who reported patient safety data and the patient safety organizations to which they reported the information; (2) what types of 

events were reported; (3) the usefulness of the analyses, information, and recommendations provided by the patient safety organizations in response to such reported data; (4) the response of providers to such analysis, information, and recommendations, including a survey of providers to determine the percentage of providers 

by category that have adopted specific error reduction methods and 

the reasons, if applicable, for not adopting such methods; and (5) 

the effectiveness of these efforts in reducing medical errors. The 

Committee intends for this report to be a thorough and vigorous review of the new system including its utility and effectiveness. 

Reason for Change. According to the IOM, nearly 100,000 patients die in hospitals each year as a result of preventable mistakes. The number of injured is far greater. The Committee believes these provisions, taken together, will reduce preventable 

medical errors and improve quality. In addition, the Committee believes the development and promulgation of voluntary interoperability standards by HHS will promote efficiency and quality of 

health care delivery, while helping to reduce costs, to the extent 

such standards are adopted by health care systems. 

Effective Date. Upon enactment. 

Section 3. Medical Information Technology Advisory Board 

Current Law. No provision. 

Explanation of Provision. Within three months of enactment, the 

Secretary would be required to appoint the Medical Information 

Technology Advisory Board (MITAB) and designate a chairman. 

The chairman would be required to be affiliated with an organization having expertise in creating American National Standards Institute (ANSI) standards governing health care information technology and to be a member of the National Committee for Vital and 

Health Statistics. The MITAB would consist of no more than 17 

members that include: (1) experts from the fields of medical information, information technology, medical continuous quality imVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00016 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
17

provement, medical records security and privacy, individual and institutional clinical providers, health researchers, and health care 

purchasers; (2) one or more staff experts from the Centers for 

Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, and the Institute of Medicine of the National 

Academy of Sciences; (3) representatives of private organizations 

with expertise in medical infomatics; (4) a representative of a 

teaching hospital; and (5) one or more representatives of the health 

care information technology industry. Individuals would be appointed for the life of the MITAB, with any vacancy filled in the 

same manner in which the original appointment was made. The 

new appointment would be made no later than 30 days after the 

MITAB is given notice of the vacancy. Such a vacancy would not 

affect the ability of the remaining members to perform the duties 

of the MITAB. 

The MITAB would meet at the call of its Chairman or a majority 

of its members. MITAB members would receive no additional pay, 

allowances, or benefits stemming from their service on the board, 

but would receive travel expenses and per diem in lieu of subsistence as directed by Sections 5702 and 5703 of Title 5 of the United 

States Code (USC). The Chairman would appoint an executive director of the MITAB who would be paid at level V of the Executive 

Schedule. With the approval of the MITAB, the director would be 

able to appoint appropriate personnel without regard to the provisions of Title 5 USC governing appointments in the competitive 

services or those relating to job classification and pay rates. The 

MITAB director would also be able to procure temporary and intermittent services under Section 3109(b) of Title 5 USC. Upon the request of MITAB, the head of any Federal agency would be able to 

detail, without reimbursement, any personnel of that agency to 

MITAB. The detail would not interrupt or affect the civil service 

status of the Federal employee. 

MITAB would be able to hold hearings and undertake other activities as necessary to carry out its duties. If requested by MITAB, 

a Federal agency would be required to provide technical assistance 

to the MITAB as deemed necessary. At the request of the MITAB 

chairman, the MITAB would be able to secure directly from any 

Federal agency information necessary to carry out its duties, if the 

information may be disclosed under the Freedom of Information 

Act (Section 552 of Title 5 USC). The Federal Advisory Committee 

Act (FACA) applies to the MITAB.

MITAB would advise, and make recommendations to, the Secretary regarding medical information technology, including: (1) best 

practices in medical information technology; (2) methods of implementing health care information technology interoperability standards, and records security; (3) a recommendation for a common 

lexicon for computer technology; and (4) and adoption within two 

years of a uniform health information system interface between old 

and new systems. MITAB would also be required to make recommendations on methods to promote information exchange to enhance compatibility among information systems in order to: (1) 

maximize positive outcomes in clinical care by providing decision 

support for diagnosis and care, and assisting in the emergency 

treatment of a patient at a facility where there is no medical record 

of the patient; (2) contribute to the development of a patient assessVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00017 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
18

ment instrument that minimizes the need for different records 

when patients move from provider to provider; (3) reduce redundant paperwork; (4) minimize medical errors; and (5) contribute to 

compatible information technology architecture. 

MITAB would be required within 18 months of enactment to submit to Congress and the Secretary an initial report of its deliberations and recommendations. Subsequent annual reports would be 

due in each of the following two years after the initial report is 

submitted. 

MITAB would terminate 30 days after the date of submission of 

its final report. The provision provides such sums as necessary for 

the operations of MITAB. 

Reason for Change. The Committee believes an advisory board on 

medical technology will promote the adoption of better, more efficient and effective health information technology systems. These 

systems will help health care providers reduce errors by making 

patient information more readily available, and promoting quality 

by providing expert advice to HHS on the adoption of interoperability standards and through promotion of information technology. 

Effective Date. Upon enactment. 

III. VOTES OF THE COMMITTEE 

In compliance with clause 3(b) of rule XIII of the Rules of the 

House of Representatives, the following statements are made concerning the votes of the Committee on Ways and Means in its consideration of the bill, H.R. 4889. 

MOTION TO REPORT THE BILL

The bill, H.R. 4889, as amended, was ordered favorably reported 

by a roll call vote of 33 yeas to 4 nays (with a quorum being 

present). The vote was as follows:

Representatives Yea Nay Present Representative Yea Nay Present 

Mr. Thomas ........................... X ........... ............. Mr. Rangel ........................... ........... ........... .............

Mr. Crane .............................. X ........... ............. Mr. Stark .............................. X ........... .............

Mr. Shaw ............................... X ........... ............. Mr. Matsui ............................ X ........... .............

Mrs. Johnson ......................... X ........... ............. Mr. Coyne ............................. X ........... .............

Mr. Houghton ........................ ........... ........... ............. Mr. Levin .............................. X ........... .............

Mr. Herger ............................. ........... ........... ............. Mr. Cardin ............................ ........... ........... .............

Mr. McCrery ........................... X ........... ............. Mr. McDermott ..................... ........... X .............

Mr. Camp .............................. X ........... ............. Mr. Kleczka ........................... ........... X .............

Mr. Ramstad ......................... X ........... ............. Mr. Lewis (GA ....................... ........... X .............

Mr. Nussle ............................. X ........... ............. Mr. Neal ............................... X ........... .............

Mr. Johnson ........................... X ........... ............. Mr. McNulty .......................... X ........... .............

Ms. Dunn .............................. X ........... ............. Mr. Jefferson ........................ X ........... .............

Mr. Collins ............................ X ........... ............. Mr. Tanner ............................ X ........... .............

Mr. Portman .......................... X ........... ............. Mr. Becerra .......................... X ........... .............

Mr. English ........................... X ........... ............. Mrs. Thurman ....................... X ........... .............

Mr. Watkins ........................... X ........... ............. Mr. Doggett .......................... ........... X .............

Mr. Hayworth ......................... X ........... ............. Mr. Pomeroy ......................... X ........... .............

Mr. Weller .............................. X ........... .............

Mr. Hulshof ........................... X ........... .............

Mr. McInnis ........................... X ........... .............

Mr. Lewis (KY) ...................... X ........... .............

Mr. Foley ............................... X ........... .............

Mr. Brady .............................. X ........... .............

Mr. Ryan ............................... X ........... .............

19

IV. BUDGET EFFECTS OF THE BILL 

A. COMMITTEE ESTIMATE OF BUDGETARY EFFECTS

In compliance with clause 3(c)(3) of rule XIII of the Rules of the 

House of Representatives, the following statement is made: 

The Committee agrees with the estimate prepared by the Congressional Budget Office (CBO), which is included below. 

B. STATEMENT REGARDING NEW BUDGET AUTHORITY AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee states the bill will increase direct spending and government receipts by less than 

$500,000 annually. 

C. COST ESTIMATE PREPARED BY THE CONGRESSIONAL BUDGET

OFFICE

In compliance with clause 3(c)(3) of rule XIII of the Rules of the 

House of Representatives requiring a cost estimate prepared by the 

Congressional Budget Office, the following report prepared by CBO 

is provided.

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, September 26, 2002. 

Hon. WILLIAM ‘‘BILL’’ M. THOMAS, Chairman, Committee on Ways and Means, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 4889, the Patient Safety 

Improvement Act of 2002. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contacts are Chris Topoleski and 

Margaret Nowak. 

Sincerely, 

STEVEN LIEBERMAN

(For Dan L. Crippen, Director). 

Enclosure. 

H.R. 4889—Patient Safety Improvement Act 2002

Summary: H.R. 4889 would expand the duties of the Center for 

Quality Improvement and Patient Safety (CQuIPS) within the 

Agency for Healthcare Research and Quality (AHRQ). CQuIPS 

would establish credentialing procedures for patient safety organizations (PSOs), which collect patient safety data voluntarily submitted by health care providers for including in a patient safety 

database. The bill also would establish privacy protections and impose fines and civil monetary penalties for violations of those protections. 

In addition H.R. 4889 would establish the Medical Information 

Technology Advisory Board (MITAB, which would provide advice 

and recommendations on the compatibility of medical information 

technologies. The bill would require the Secretary of Health and 

20

Human Services, with the National Committee for Vital and 

Health Statistics and the MITAB, to develop voluntary national 

standards for uniform reporting of health care information. CBO estimates that implementing H.R. 4889 would cost $6 mil- lion in 2003 and $58 million over the 2003–2007 period, assuming 

the appropriation of the necessary amounts. CBO estimates that 

receipts from fines for violation of the privacy protections would 

amount to less than $500,000 a year. Because the legislation would 

affect receipts and direct spending, pay-as-you-go procedures would 

apply. 

H.R. 4889 would preempt any state freedom-of-information law 

that would require the disclosure of information provided by a 

health care provider to a certified patient safety organization. This 

preemption would be an intergovernmental mandate as defined in 

the Unfunded Mandates Reform Act (UMRA) because it would 

limit the application of such state laws. CBO estimates that this 

mandate would impose no requirement on states that would result 

in additional spending; thus, the threshold established by UMRA 

($58 million in 2002, adjusted annually for inflation) would not be 

exceeded. 

H.R. 4889 contains no private-sector mandates as defined in 

UMRA. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 4889 is shown in the following table. The costs 

of this legislation fall within budget function 550 (health).

By fiscal year, in millions of dollars— 

2002 2003 2004 2005 2006 2007

CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Level ...................................................... 0 12 14 15 13 13

Estimated Outlays ........................................................................ 0 6 11 14 14 13

CHANGES IN REVENUES

Estimated Revenues ..................................................................... 0 * * * * *

CHANGES IN DIRECT SPENDING

Estimated Budget Authority ......................................................... 0 * * * * *

Estimated Outlays ........................................................................ 0 * * * * *

Note.—* = Less than $500,000. 

Basis of estimate 

Spending subject to appropriation 

H.R. 4889 would expand the current duties of CQuIPS. The new 

duties would include the provision of technical assistance to states 

that have (or are developing) systems for reporting medical errors. 

CQuIPS also would provide for the certification and recertification 

of PSOs, which collect patient safety data from health care providers. (PSOs are private or public organizations that conduct activities to improve patient safety and the quality of health care delivery). PSOs would not receive funding under this bill. In addition, 

CQuIPS would establish a patient safety database to collect, support, and coordinate the analysis of patient safety data that is reported on a voluntary basis. Based on information from AHRQ, 

CBO expects that these tasks would require increased staff for providing assistance to states, oversight of PSOs, and collection and 

maintenance of the patient safety database. They would also reVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00020 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
21

quire additional computer resources for the database. Based on information from AHRQ, CBO estimates that the agency would need 

additional appropriations of $10 million in 2003 and $61 million 

over the 2003–2007 period to carry out these responsibilities. CBO estimates that outlays would total $4 million in fiscal year 2003 

and $51 million over the 2003–2007 period, assuming the necessary 

amounts are appropriated. 

The bill would require the Secretary to develop voluntary, national standards that promote the compatibility of health care information technology systems across all health care settings. CBO 

estimates that this effort would not involve significant additional 

costs. 

In addition, H.R. 4889 would require the Comptroller General of 

the United States to report to the Congress the findings of comprehensive evaluation of PSOs, the usefulness of the reported information and the overall effectiveness of the program in reducing 

medical errors. CBO estimates that these tasks would cost the 

General Accounting Office $1 million in 2003 and $2 million over 

the 2003–2007 period. 

Finally, the bill would establish the MITAB to provide recommendations regarding medical information technology. The 

MITAB would terminate 30 days after the submisswion of its final 

report. For purposes of this estimate, CBO assumed that the 

MITAB would be created in January 2003, and therefore would terminate in July 2006. As stated in the bill, the MITAB would require one Executive Level V employee and support staff. In addition, while board members would not be compensated for their time 

serving on the MITAB, reimbursement for travel and per-diem expenses would be allowed. CBO estimates that the MITAB would require appropriations of about $1 million a year over the 2003–2007 

period. We estimate that outlays would total $0.6 million in fiscal 

year 2003 and $5 million over the 2003–2007 period, assuming the 

necessary amounts are appropriated. 

Direct spending and revenues 

Because those prosecuted and convicted for violation of the bill’s 

privacy provisions could be subject to criminal fines and civil monetary penalties, the federal government might collect additional 

fines if the bill is enacted. Collections of civil fines are recorded in 

the budget as governmental receipts (revenues). Criminal fines are 

deposited as receipts in the Crime Victims Fund and later spent. 

CBO estimates that any additional receipts and direct spending 

would be less than $500,000. 

Pay-as-you-go considerations: The Balanced Budget and Emergency Deficit Control Act sets up pay-as-you-go procedures for legislation affecting direct spending or receipts. Enacting H.R. 4889 

could affect receipts and direct spending through the collection of 

fines for noncompliance with the privacy standards, but CBO estimates that any such effects would be less than $500,000 a year. 

Estimated impact on state, local, and tribal governments: H.R. 

4889 would preempt any state freedom-of-information law that 

would require the disclosure of information provided by a health 

care provider to a certified patient safey organization. This preemption would be an intergovernmental mandate as defined in UMRA 

because it would limit the application of such state laws. CBO estiVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00021 Fmt 6659 Sfmt 6602 E:\HR\OC\HR714P1.XXX HR714P1
22

mates that this mandate would impose no requirement on states 

that would result in additional spending; thus, the threshold established by UMRA ($58 million in 2002, adjusted annually for inflation) would not be exceeded. 

Estimated impact on the private sector: H.R. 4889 contains no 

private-sector mandates as defined in UMRA. 

Estimate prepared by: Federal Revenues and Outlays: Chris 

Topoleski and Margaret Nowak; Impact on State, Local, and Tribal 

Governments: Leo Lex; and Impact on the Private Sector: Daniel 

Wilmoth. 

Estimate approved by: Robert A. Sunshine, Assistant Director for 

Budget Analysis.

V. OTHER MATTERS REQUIRED TO BE DISCUSSED 

UNDER THE RULES OF THE HOUSE 

A. COMMITTEE OVERSIGHT FINDINGS AND RECOMMENDATIONS

In compliance with clause 3(c)(1) of rule XIII of the Rules of the 

House of Representatives, the Committee reports that the need for 

this legislation was verified by the two hearings conducted by the 

Committee. Details of these hearings are included in Section I. Introduction, Part B. Legislative History. 

B CONSTITUTIONAL AUTHORITY STATEMENT

In compliance with clause 3(d)(1) of rule XIII of the Rules of the 

House of Representatives, the Committee states that the Committee’s action in reporting this bill is derived from Article I of the 

Constitution, Section 8 (‘‘The Congress shall have Power to lay and 

collect taxes, duties, imposts and excises, to pay the debts and to 

provide for * * * the General Welfare.’’) 

C. INFORMATION RELATING TO UNFUNDED MANDATES

This information is provided in accordance with section 423 of 

the Unfunded Mandates Act of 1995 (P.O. 104–4). 

The Committee has determined that the bill does not contain 

Federal mandates on the private sector. The Committee has determined that the bill does not impose a Federal intergovernmental 

mandate on State, local, or tribal governments, but that such mandate will have no budgetary impact on those entities. The bill, however, also provides assistance to State governments. It requires the 

Secretary of Health and Human Services to provide technical assistance to State governments in developing or maintaining State 

reporting systems, developing standardized methods of data collection, and in collecting data from State governments for inclusion in 

the Patient Safety Database. In addition, the legislation allows the 

Secretary to provide technical assistance to the patient safety organizations established under the bill. 

D. SUMMARY OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

In compliance with clause 3(c)(4) of rule XIII of the Rules of the 

House of Representatives, the Committee states that the primary 

purpose of H.R. 4889 is to reduce medical errors, thereby improving 

patient safety.

23

VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS 

REPORTED 

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (new matter is printed in italic 

and existing law in which no change is proposed is shown in 

roman): 

SOCIAL SECURITY ACT 

* * * * * * *

TITLE XI—GENERAL PROVISIONS, PEER REVIEW, AND 

ADMINISTRATIVE SIMPLIFICATION 

* * * * * * *

PART D—PATIENT SAFETY IMPROVEMENTS

VOLUNTARY REPORTING OF PATIENT SAFETY DATA; DEFINITIONS

SEC. 1181. (a) COLLECTION AND VOLUNTARY REPORTING OF PA- TIENT SAFETY DATA.—In order to improve patient safety and the 

quality of health care delivery, a health care provider (as defined in 

subsection (d)) may voluntarily collect and develop patient safety 

data (as defined in subsection (e)) and report such data to one or 

more patient safety organizations (as defined in subsection (f)) in a 

manner that is confidential and privileged (as described in section 

1182). 

(b) USE OF PATIENT SAFETY DATA BY PATIENT SAFETY ORGANIZATIONS.—Patient safety organizations shall analyze the patient safety 

data reported and develop (and report back to health care providers) 

information to improve patient safety and the quality of health care 

delivery and shall submit non-identifiable information derived from 

such data in a uniform manner to the Center for Quality Improvement and Patient Safety (for inclusion in the Patient Safety Database, if applicable). Such non-identifiable information may be disclosed and shared with other patient safety organizations. Identifiable patient safety data may be disclosed to other patient safety organizations with the explicit authorization for each such disclosure 

by the reporting provider involved. 

(c) FUNCTIONS OF CENTER.—The Center for Quality Improvement 

and Patient Safety conducts patient safety activities consistent with 

section 1183. 

(d) HEALTH CARE PROVIDERS COVERED.—For purposes of this 

part, the term ‘‘health care provider’’ means—

(1) a provider of services (as defined in section 1861(u) and 

including a hospital, skilled nursing facility, home health agency, and hospice program) that provides services for which payment may be made under part A of title XVIII and the provider’s employees; 

(2) a health care entity or individual that furnishes medical 

or other health services (as defined in section 1861(s)), other 

services described in section 1832(a)(2), or other items and services for which payment may be made under such title, including 

a physician (as defined in section 1861(r)); and 

24

(3) an organization offering a plan under part C of title 

XVIII. 

(e) PATIENT SAFETY DATA COVERED.— (1) IN GENERAL.—For purposes of this part, the term ‘‘patient 

safety data’’ means any data, reports, records, memoranda, 

analyses, deliberative work, statements, or root cause analyses 

that are collected or developed to improve patient safety or 

health care quality and that— (A) are collected or developed by a health care provider 

for the purpose of reporting to a patient safety organization 

and that are reported on a timely basis to such an organization; 

(B) are collected or developed by a patient safety organization or by (or on behalf of) the Center for Quality Improvement and Patient Safety, regardless of whether the 

data are transmitted to the health care provider that reported the original data; or 

(C) describes corrective actions taken by a health care 

provider in response to the provider’s reporting of data to 

that organization, regardless of whether the organization 

has transmitted under subsection (f)(2) information to the 

health care provider that reported the original data, and 

that are reported on a timely basis to such an organization. 

(2) CONSTRUCTION REGARDING USE OF DATA.— (A) INTERNAL USE PERMITTED TO IMPROVE PATIENT SAFE- TY, QUALITY, AND EFFICIENCY.—Nothing in this part shall 

be construed to limit or discourage a health care provider 

from developing and using patient safety data within the 

provider to improve patient safety, health care quality, or 

administrative efficiency of the provider. 

(B) TREATMENT.—Information that is collected or developed as patient safety data is not disqualified from being 

treated as patient safety data because of its development or 

use for the purposes described in subparagraph (A) and 

such development or use shall not constitute a waiver of 

any privilege or protection established under section 1182 

or under State law. 

(f) QUALIFICATIONS OF PATIENT SAFETY ORGANIZATIONS.— (1) IN GENERAL.—For purposes of this part, the term ‘‘patient 

safety organization’’ means a private or public organization 

that conducts activities to improve patient safety and the quality of health care delivery by assisting health care providers 

that report to such organizations and that has been certified by 

the Secretary as— (A) performing each of the activities described in paragraph (2); and 

(B) meets the other requirements of paragraphs (3) 

through (5). 

(2) ACTIVITIES DESCRIBED.—The activities referred to in paragraph (1)(A) are the following: 

(A) The collection and analysis of patient safety data that 

are voluntarily reported by more than one health care provider on a local, regional, State, or national basis. 

(B) The development and dissemination of information to 

health care providers and other patient safety organizations 

25

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

practices. 

(C) The utilization of patient safety data to carry out activities under this paragraph to improve patient safety and 

to provide assistance to health care providers to minimize 

patient risk. 

(3) CONDUCT OF ACTIVITIES.—In conducting activities under 

paragraph (2), a patient safety organization shall— (A) maintain confidentiality with respect to individually 

identifiable health information; 

(B) submit non-identifiable information to the Center for 

Quality Improvement and Patient Safety in a format established by the Secretary; and 

(C) maintain appropriate security measures with respect 

to patient safety data. 

(4) ORGANIZATION REQUIREMENTS.—The requirements of this 

paragraph for an organization are that— (A) the organization is managed, controlled, and operated 

independently from health care providers which report patient safety data to it under this part; 

(B) if the organization no longer qualifies as a patient 

safety organization, with respect to any patient safety data 

that it received from a health care provider, the organization shall do one of the following: 

(i) with the approval of the provider and another patient safety organization, transfer such data to such 

other organization; 

(ii) if practicable, return the data to the provider; or 

(iii) destroy the patient safety data; 

(C) if the organization charges a fee for the activities it 

performs with respect to health care providers, the fee shall 

be uniform among all classes or types of health care providers (taking into account the size of the health care provider); 

(D) the organization seeks to collect data from health care 

providers in a standardized manner that permits valid 

comparisons of similar cases among similar health care 

providers; and 

(E) the organization meets such other requirements as the 

Secretary may by regulation require. 

For purposes of subparagraph (A), an organization is controlled 

by a health care provider if the provider is able to significantly 

influence or direct the actions or policies of the organization. 

(5) LIMITATION ON USE OF PATIENT SAFETY DATA BY PATIENT

SAFETY ORGANIZATIONS.—A patient safety organization may not 

use patient safety data reported by a health care provider in accordance with this part to take regulatory or enforcement actions it otherwise performs (or is responsible for performing) in 

relation to such provider. 

(6) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to patient safety organizations in providing recommendations and advice to health care providers reporting 

patient safety data under this part. Such assistance shall include advice with respect to methodology, communication, disVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00025 Fmt 6659 Sfmt 6603 E:\HR\OC\HR714P1.XXX HR714P1
26

semination of information, data collection, security, and confidentiality concerns. 

(g) CONSTRUCTION.—Nothing in this part shall be construed to 

limit or discourage the reporting of information relating to patient 

safety within a health care provider. 

CONFIDENTIALITY AND PEER REVIEW PROTECTIONS

SEC. 1182. (a) IN GENERAL.—Notwithstanding any other provision of law, patient safety data shall be privileged and confidential 

in accordance with this section. 

(b) SCOPE OF PRIVILEGE.—Subject to the succeeding provisions of 

this section, such data shall not be— (1) subject to a civil or administrative subpoena; 

(2) subject to discovery in connection with a civil or administrative proceeding; 

(3) disclosed pursuant to section 552 of title 5, United States 

Code (commonly known as the Freedom of Information Act) or 

any other similar Federal or State law; or 

(4) admitted as evidence or otherwise disclosed in any civil or 

administrative proceeding. 

(c) CLARIFICATION OF SCOPE.—The privilege established by this 

section with respect to patient safety data described in section 

1181(e)(1)(A) shall apply to information, such as records of a patient’s medical diagnosis and treatment, other primary health care 

information, and other information, to the extent that such information was collected or developed for the purpose specified in such section and is reported in accordance with such section. Such privilege 

shall not apply to information merely by reason of its inclusion, or 

the fact of its submission, in a report under such section. Information available from sources other than a report made under such 

section may be discovered or admitted in a civil or administrative 

proceeding, if discoverable or admissible under applicable state law. 

(d) INFORMATION NOT SUBJECT TO PRIVILEGE.—The privilege established by this section shall not apply to one or more of the following: 

(1) MEDICAL RECORDS AND OTHER PRIMARY HEALTH

RECORDS.—Records of a patient’s medical diagnosis and treatment and other primary health records of a health care provider. Such privilege shall not apply to such information by 

reason of its inclusion within patient safety data. 

(2) FDA.—Relevant information disclosed by a health care 

provider or patient safety organization to the Food and Drug 

Administration, or to a person that is subject to the jurisdiction 

of such Administration, with respect to an Administration-regulated product or activity for which that entity has responsibility, for the purposes of activities related to quality, safety, or 

effectiveness of such Administration-regulated product or activity, subject to section 520(c) of the Federal Food, Drug, and Cosmetic Act. 

(3) NON-IDENTIFIABLE INFORMATION USED BY DATABASE.—

Non-identifiable information from a patient safety organization 

to the Patient Safety Database and the further disclosure of 

such data by the Center for Quality Improvement and Patient 

Safety. 

(e) REPORTER PROTECTION.—

27

(1) IN GENERAL.—A health care provider may not use against 

an individual in an adverse employment action described in 

paragraph (2) the fact that the individual in good faith reported—

(A) to the provider with the intention of having it reported to a patient safety organization, or 

(B) directly to a patient safety organization, 

information that would constitute patient safety data under section 1181(e)(1)(A) if the provider were to have submitted it on 

a timely basis to a patient safety organization in accordance 

with such section. 

(2) ADVERSE EMPLOYMENT ACTION.—For purposes of this subsection, an ‘‘adverse employment action’’ includes—

(A) the failure to promote an individual or provide any 

other employment-related benefit for which the individual 

would otherwise be eligible; 

(B) an evaluation or decision made in relation to accreditation, certification, credentialing or licensing of the individual; and 

(C) a personnel action that is adverse to the individual 

concerned. 

(3) REMEDIES.—The provisions of the first sentence of section 

1128A(a) shall apply with respect to a health care provider’s 

violation of paragraph (1) in the same manner as they apply to 

an act referred to in section 1128A(a)(7). 

(f) PENALTY.—It is unlawful for any person to disclose any patient 

safety data in violation of the provisions of this section. Any person 

violating such provisions shall subject to the same sanctions under 

section 1160(c) (relating to, upon conviction, a fine of not more than 

$1,000, imprisonment for not more than 6 months, or both, per disclosure and payment of the costs of prosecution) as a person who 

discloses any information described in section 1160(a). 

(g) RULES OF CONSTRUCTION.—

(1) NO LIMITATION OF OTHER PRIVILEGES.—Subject to paragraph (2), nothing in this section shall be construed as affecting 

other privileges that are available under Federal or State laws 

that provide greater peer review or confidentiality protections 

than the peer review and confidentiality protections provided 

for in this section. 

(2) NO EFFECT ON STATE MANDATORY REPORTING REQUIREMENTS.—Nothing in this part shall be construed as preempting 

or otherwise affecting any State law mandatory reporting requirement for health care providers. 

(h) APPLICATION OF PRIVACY REGULATIONS.—For purposes of applying the regulations promulgated pursuant to section 264(c) of the 

Health Insurance Portability and Accountability Act of 1996 (Public 

Law 104-191; 110 Stat. 2033)—

(1) patient safety organizations shall be treated as business 

associates; 

(2) activities of such organizations described in section 

1181(f)(2)(A) in relation to a health care provider are deemed 

to be health care operations of the provider; and 

(3) the disclosure of identifiable information under the voluntary program under this part by such an organization shall 

28

be treated as necessary for the proper management and administration of the organization. 

Nothing in this section shall be construed to alter or affect the implementation of such regulation or such section 264(c). 

(i) WAIVERS.—Nothing in this part shall be construed as precluding a health care provider from waiving the privilege or confidentiality protections under this section. Disclosure of patient safety data under subsection (d)(2) shall not constitute a waiver of any 

privilege or protection established under this section or under State 

law. 

(j) CONTINUATION OF PRIVILEGE.—Patient safety data of an organization that is certified as a patient safety organization shall continue to be privileged and confidential, in accordance with this section, if the organization’s certification is terminated or revoked or 

if the organization otherwise ceases to qualify as a patient safety organization until the data are otherwise disposed of in accordance 

with section 1181(f)(4). 

(k) SURVEY AND REPORT.— –– (1) SURVEY.—The Comptroller General of the United States 

shall conduct a survey of State laws that relate to patient safety 

data peer review systems, including laws that establish an evidentiary privilege applicable to data developed in such systems, 

and shall review the manner in which such laws have been interpreted by the courts and the effectiveness of such laws in promoting patient safety. 

(2) REPORT.—Not later than 9 months after the date of enactment of this section, the Comptroller General shall prepare and 

submit to Congress a report concerning the results of the survey 

conducted under paragraph (1). 

CENTER FOR QUALITY IMPROVEMENT AND PATIENT SAFETY

SEC. 1183. (a) IN GENERAL.—The Secretary, acting through the 

Director of the Agency for Healthcare Research and Quality, shall 

ensure that the Center for Quality Improvement and Patient Safety 

(in this section referred to as the ‘‘Center’’) supports public and private sector initiatives to improve patient safety for items and services furnished through health care providers. 

(b) DUTIES.—

(1) IN GENERAL.—The Secretary, acting through the Director, 

shall ensure that the Center carries out the following duties: 

(A) Provide for the certification and recertification of patient safety organizations in accordance subsection (d). 

(B) Collect and disseminate information related to patient safety. 

(C) Establish a Patient Safety Database to collect, support, and coordinate the analysis of non-identifiable information submitted to the Database in accordance with subsection (e). 

(D) Facilitate the development of consensus among health 

care providers, patients, and other interested parties concerning patient safety and recommendations to improve patient safety. 

(E) Provide technical assistance to States that have (or 

are developing) medical errors reporting systems, assist 

States in developing standardized methods for data collecVerDate Sep 04 2002 22:06 Oct 03, 2002 Jkt 019006 PO 00000 Frm 00028 Fmt 6659 Sfmt 6603 E:\HR\OC\HR714P1.XXX HR714P1
29

tion, and collect data from State reporting systems for inclusion in the Patient Safety Database. 

(2) CONSULTATION.—In carrying out the duties under paragraph (1) (including the establishment of the Database), the 

Secretary shall consult with and develop partnerships, as appropriate, with health care organizations, health care providers, 

public and private sector entities, patient safety organizations, 

health care consumers, and other relevant experts to improve 

patient safety. 

(c) CERTIFICATION AND RECERTIFICATION PROCESS.— (1) IN GENERAL.—The initial certification and recertification 

of a patient safety organization under subsection (b)(1)(A) shall 

be made under a process that is approved by the Secretary and 

is consistent with criteria published by the Secretary. 

(2) REVOCATION.—Such a certification or recertification may 

be revoked by the Secretary upon a showing of cause (including 

the disclosure of data in violation of section 1182). 

(3) TERMINATION.—Such a certification provided for a patient 

safety organization shall terminate (subject to recertification) on 

the earlier of— (A) the date that is 3 years after the date on which such 

certification was provided; or 

(B) the date on which the Secretary revokes the certification. 

(d) IMPLEMENTATION AND CONSULTATION.—In carrying out subsection (c)(1), the Secretary shall— (1) facilitate the development of patient safety goals and track 

the progress made in meeting those goals; and 

(2) ensure that data submitted by a patient safety organization to the Patient Safety Database, as provided for under subsection (e), are comparable and useful for research and analysis 

and that the research findings and patient safety alerts that result from such analyses are presented in clear and consistent 

formats that enhance the usefulness of such alerts. 

(e) PATIENT SAFETY DATABASE.— (1) IN GENERAL.—The Secretary, acting through the Director, 

shall—

(A) establish a Patient Safety Database to collect nonidentifiable information concerning patient safety that is reported on a voluntary basis; and 

(B) establish common formats for the voluntary reporting 

of data under subparagraph (A), including the establishment of necessary data elements, common and consistent 

definitions, and a standardized computer interface for the 

processing of such data. 

(2) DATABASE.—In carrying out this subsection, the Secretary—

(A) shall establish and modify as necessary criteria to determine the organizations that may voluntarily contribute 

to, and the data that comprises, the Patient Safety Database; 

(B) shall ensure that the Patient Safety Database is only 

used by qualified entities or individuals as determined appropriate by the Secretary in accordance with criteria applied by the Secretary; and 

30

(C) may enter into contracts for the administration of the 

Database with private and public entities with experience 

in the administration of similar databases. 

(3) NON-IDENTIFIABLE INFORMATION.—For purposes of this 

part, the term ‘‘non-identifiable information’’ means information 

that is presented in a form and manner that prevents the identification of any health care provider, patient, and the reporter 

of the information. 

(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to 

be appropriated such sums as may be necessary for each fiscal year 

to carry out this section. 

INTEROPERABILITY STANDARDS FOR HEALTH CARE INFORMATION

TECHNOLOGY SYSTEMS

SEC. 1184. (a) IN GENERAL.—By not later than 2 years after the 

date of the enactment of this part, the Secretary shall develop or 

adopt (and shall periodically review and update) voluntary, national standards that promote the interoperability of health care information technology systems across all health care settings. In promulgating regulations to carry out this section, the Secretary shall 

take into account the cost that meeting such standards would have 

on providing health care in the United States and the increased efficiencies in providing such care achieved under the standards. 

(b) CONSULTATION AND COORDINATION.—The Secretary shall develop and update such standards in consultation with (and with coordination between)—

(1) the National Committee for Vital and Health Statistics, 

and 

(2) the Medical Information Technology Advisory Board (established under section 3 of the Patient Safety Improvement Act 

of 2002). 

(c) DISSEMINATION.—The Secretary shall provide for the dissemination of the standards developed and updated under this section. 

(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to 

be appropriated such sums as may be necessary for each fiscal year 

to carry out this section. 

VOLUNTARY ADOPTION OF METHODS TO IMPROVE PATIENT SAFETY

SEC. 1185. The Secretary shall encourage health care providers to 

adopt appropriate evidence-based methods to improve patient safety. 

Such methods shall not constitute national practice guidelines. 

EVALUATION AND REPORT

SEC. 1186. (a) EVALUATION.—The Comptroller General of the 

United States shall conduct a comprehensive evaluation of the implementation of this part. Such evaluation shall include an examination of the following: 

(1) The health care providers that reported patient safety data 

under this part and the patient safety organizations to which 

they reported the information. 

(2) What types of events were so reported on. 

(3) The usefulness of the analyses, information, and recommendations provided by patient safety organizations in response to such reported information. 

31

(4) The response of health care providers to such analyses, information, and recommendations, including a survey of providers to obtain estimates of the percentage of providers by category who have adopted specific error-reduction methods and, 

if applicable, reasons for not adopting specific practices. 

(5) The effectiveness of the program under this part in reducing medical errors. 

(b) REPORT.—Not later than 5 years after the date the provisions 

of this part are first implemented, the Comptroller General shall 

submit to Congress a report on the evaluation conducted under subsection (a). 

* * * * * * *

Æ